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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended December 31, 2023
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____ to _____
Commission
file number: 001-35570
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware |
|
20-2932652 |
(State
or Other Jurisdiction of |
|
(I.R.S.
Employer |
Incorporation
or Organization) |
|
Identification
No.) |
100
Overlook Center, Suite 102, Princeton, NJ |
|
08540 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
(609)
375-2227
(Registrant’s
Telephone Number, Including Area Code)
Not
applicable
(Former
Name, Former Address and Former Fiscal Year, if Changed Since Last Report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
|
SONN |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒ Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
|
|
|
|
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
|
|
|
|
Emerging
growth company |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
☐
Yes ☒ No
There
were 3,069,516 shares of common stock, par value $0.0001 per share, of Sonnet BioTherapeutics Holdings, Inc. issued and outstanding as
of February 7, 2024.
Sonnet
BioTherapeutics Holdings, Inc. and Subsidiaries
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
INDEX
TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
PART
I - FINANCIAL INFORMATION
Item
1: Financial Statements.
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Balance Sheets
(unaudited)
| |
December
31, 2023 | | |
September
30, 2023 | |
Assets | |
| | | |
| | |
Current
assets: | |
| | | |
| | |
Cash | |
$ | 3,021,392 | | |
$ | 2,274,259 | |
Prepaid
expenses and other current assets | |
| 1,408,280 | | |
| 1,677,396 | |
Incentive
tax receivable | |
| 194,111 | | |
| 786,574 | |
Total
current assets | |
| 4,623,783 | | |
| 4,738,229 | |
Property
and equipment, net | |
| 30,155 | | |
| 33,366 | |
Operating
lease right-of-use asset | |
| 176,926 | | |
| 193,689 | |
Deferred
offering costs | |
| 15,000 | | |
| 49,988 | |
Other
assets | |
| 491,862 | | |
| 414,206 | |
Total
assets | |
$ | 5,337,726 | | |
$ | 5,429,478 | |
Liabilities
and stockholders’ equity (deficit) | |
| | | |
| | |
Current
liabilities: | |
| | | |
| | |
Accounts
payable | |
$ | 1,655,390 | | |
$ | 2,201,999 | |
Accrued
expenses and other current liabilities | |
| 923,191 | | |
| 3,230,922 | |
Current
portion of operating lease liability | |
| 75,730 | | |
| 73,048 | |
Deferred
income | |
| — | | |
| 18,626 | |
Total
current liabilities | |
| 2,654,311 | | |
| 5,524,595 | |
Operating
lease liability, net of current portion | |
| 110,956 | | |
| 130,863 | |
Total
liabilities | |
| 2,765,267 | | |
| 5,655,458 | |
Commitments
and contingencies (Note 4) | |
| - | | |
| - | |
Stockholders’
equity (deficit): | |
| | | |
| | |
Common
stock, $0.0001 par value: 125,000,000 shares authorized; 3,069,516 and 1,750,426 issued and outstanding at December 31, 2023 and
September 30, 2023, respectively | |
| 307 | | |
| 175 | |
Additional
paid-in capital | |
| 113,984,414 | | |
| 110,017,598 | |
Accumulated
deficit | |
| (111,412,262 | ) | |
| (110,243,753 | ) |
Total
stockholders’ equity (deficit) | |
| 2,572,459 | | |
| (225,980 | ) |
Total
liabilities and stockholders’ equity (deficit) | |
$ | 5,337,726 | | |
$ | 5,429,478 | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Statements of Operations
(unaudited)
| |
2023 | | |
2022 | |
| |
Three
Months Ended December 31, | |
| |
2023 | | |
2022 | |
Collaboration
revenue | |
$ | 18,626 | | |
$ | 37,255 | |
Operating expenses: | |
| | | |
| | |
Research and development | |
| 644,042 | | |
| 3,745,940 | |
General
and administrative | |
| 653,455 | | |
| 1,903,709 | |
Total
operating expenses | |
| 1,297,497 | | |
| 5,649,649 | |
Loss from operations | |
| (1,278,871 | ) | |
| (5,612,394 | ) |
Foreign exchange gain | |
| 110,362 | | |
| 70,252 | |
Net
loss | |
$ | (1,168,509 | ) | |
$ | (5,542,142 | ) |
| |
| | | |
| | |
Per share information: | |
| | | |
| | |
Net loss per share,
basic and diluted | |
$ | (0.31 | ) | |
$ | (17.62 | ) |
Weighted average shares outstanding, basic
and diluted | |
| 3,797,753 | | |
| 314,472 | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Statements of Changes in Stockholders’ Equity (Deficit)
(unaudited)
| |
Shares | | |
Amount | | |
capital | | |
deficit | | |
Total | |
| |
Common
stock | | |
Additional
paid-in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
capital | | |
deficit | | |
Total | |
Balance at October
1, 2023 | |
| 1,750,426 | | |
$ | 175 | | |
$ | 110,017,598 | | |
$ | (110,243,753 | ) | |
$ | (225,980 | ) |
Sale of common stock, net
of issuance costs | |
| 1,306,250 | | |
| 131 | | |
| 3,916,812 | | |
| — | | |
| 3,916,943 | |
Retirement of shares in connection
with reverse stock split | |
| (1,522 | ) | |
| — | | |
| — | | |
| — | | |
| — | |
Net share settlement of warrants | |
| 14,362 | | |
| 1 | | |
| (1 | ) | |
| — | | |
| — | |
Share-based compensation | |
| — | | |
| — | | |
| 50,005 | | |
| — | | |
| 50,005 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (1,168,509 | ) | |
| (1,168,509 | ) |
Balance
at December 31, 2023 | |
| 3,069,516 | | |
$ | 307 | | |
$ | 113,984,414 | | |
$ | (111,412,262 | ) | |
$ | 2,572,459 | |
| |
Common
stock | | |
Additional
paid-in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
capital | | |
deficit | | |
Total | |
Balance at October
1, 2022 | |
| 251,973 | | |
$ | 25 | | |
$ | 88,872,315 | | |
$ | (91,411,059 | ) | |
$ | (2,538,719 | ) |
Balance | |
| 251,973 | | |
$ | 25 | | |
$ | 88,872,315 | | |
$ | (91,411,059 | ) | |
$ | (2,538,719 | ) |
Sale of common stock, net
of issuance costs | |
| 109,841 | | |
| 11 | | |
| 4,452,001 | | |
| — | | |
| 4,452,012 | |
Net share settlement of warrants | |
| 137 | | |
| — | | |
| — | | |
| — | | |
| — | |
Share-based compensation | |
| — | | |
| — | | |
| 91,617 | | |
| — | | |
| 91,617 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (5,542,142 | ) | |
| (5,542,142 | ) |
Balance
at December 31, 2022 | |
| 361,951 | | |
$ | 36 | | |
$ | 93,415,933 | | |
$ | (96,953,201 | ) | |
$ | (3,537,232 | ) |
Balance | |
| 361,951 | | |
$ | 36 | | |
$ | 93,415,933 | | |
$ | (96,953,201 | ) | |
$ | (3,537,232 | ) |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Statements of Cash Flows
(unaudited)
| |
2023 | | |
2022 | |
| |
Three
Months Ended December 31, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (1,168,509 | ) | |
$ | (5,542,142 | ) |
Adjustments to reconcile
net loss to net cash used in operating activities: | |
| | | |
| | |
Acquired in-process research
and development | |
| 12,000 | | |
| 100,000 | |
Amortization of operating
lease right-of-use asset | |
| 16,763 | | |
| 15,223 | |
Share-based compensation | |
| 50,005 | | |
| 91,617 | |
Changes in operating assets
and liabilities: | |
| | | |
| | |
Prepaid expenses and other
current assets | |
| 269,116 | | |
| 82,673 | |
Incentive tax receivable | |
| 592,463 | | |
| (619,118 | ) |
Other assets | |
| (77,656 | ) | |
| — | |
Accounts payable | |
| (465,735 | ) | |
| (375,540 | ) |
Accrued expenses and other
current liabilities | |
| (2,287,544 | ) | |
| 383,362 | |
Operating lease liability | |
| (17,225 | ) | |
| (17,201 | ) |
Deferred
income | |
| (18,626 | ) | |
| (37,255 | ) |
Net
cash used in operating activities | |
| (3,091,737 | ) | |
| (5,915,170 | ) |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds
from sale of common stock, net of issuance costs | |
| 3,838,870 | | |
| 4,562,895 | |
Net
cash provided by financing activities | |
| 3,838,870 | | |
| 4,562,895 | |
| |
| | | |
| | |
Net increase (decrease) in cash | |
| 747,133 | | |
| (1,352,275 | ) |
Cash, beginning of period | |
| 2,274,259 | | |
| 3,052,879 | |
Cash, end of period | |
$ | 3,021,392 | | |
$ | 1,700,604 | |
| |
| | | |
| | |
Supplemental disclosure of non-cash operating,
investing and financing activities: | |
| | | |
| | |
In-process research
and development in accrued expenses | |
$ | 12,000 | | |
$ | 261,250 | |
Offering costs in accounts
payable and accrued expenses | |
$ | 15,000 | | |
$ | 138,878 | |
Deferred offering costs
charged against proceeds from sale of common stock | |
$ | — | | |
$ | 32,340 | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
1.
Organization and Description of Business
Description
of business
Sonnet
BioTherapeutics, Inc. (“Prior Sonnet”) was incorporated as a New Jersey corporation on April 6, 2015. Prior Sonnet
completed a merger with publicly-held Chanticleer Holdings, Inc. (“Chanticleer”) on April 1, 2020. After the merger,
Chanticleer changed its name to Sonnet BioTherapeutics Holdings, Inc. (“Sonnet” or the “Company”). Sonnet is
a clinical stage, oncology-focused biotechnology company with a proprietary platform for innovating biologic medicines with single or bifunctional action. Known as FHAB™ (Fully Human Albumin Binding), the technology utilizes a fully human
single chain antibody fragment (scFv) that binds to and “hitch-hikes” on human serum albumin (“HSA”) for
transport to target tissues.
Sonnet’s
lead proprietary asset, SON-1010, is a fully human single chain version of Interleukin 12 (“IL-12”), covalently linked
to the FHAB construct, for which Sonnet is pursuing clinical development in solid tumor indications, including ovarian
cancer, non-small cell lung cancer and head and neck cancer. In March 2022, the FDA cleared Sonnet’s Investigational New Drug
(“IND”) application for SON-1010. This allowed the Company to initiate a U.S. clinical trial (SB101) in oncology
patients with solid tumors during the second calendar quarter of 2022. In September 2021, the Company created a wholly-owned
Australian subsidiary, SonnetBio Pty Ltd (“Subsidiary”), for the purpose of conducting certain clinical trials in that country. Sonnet
received approval and initiated an Australian clinical study (SB102) of SON-1010 in healthy volunteers during the third calendar
quarter of 2022. Interim safety and tolerability data from the SB101 and SB102 studies were reported in April 2023.
In
January 2023, Sonnet announced a collaboration agreement with Roche for the clinical evaluation of SON-1010 with atezolizumab (Tecentriq®).
The companies have entered into a Master Clinical Trial and Supply Agreement (“MCSA”), along with ancillary Quality and Safety
Agreements, to study the safety and efficacy of the combination of SON-1010 and atezolizumab in a platinum-resistant ovarian cancer (“PROC”)
patient setting. Furthermore, the companies will provide SON-1010 and atezolizumab, respectively, for use in the Phase 1b/Phase 2a combination
safety, dose-escalation, and efficacy study (SB221). Part 1 of this 2-part study was approved in June 2023 by the local Human Research
Ethics Committee in Australia under CT-2023-CTN-01399-1 and the Therapeutic Goods Administration has been notified. In August 2023, the
FDA accepted the IND for SON-1010 in this indication. The trial consists of a modified 3+3 dose-escalation design in Part 1 to establish the maximum tolerated
dose (“MTD”) of SON-1010 with a fixed dose of atezolizumab. Clinical benefit in PROC will be confirmed in an expansion group
to establish the recommended Phase 2 dose (“RP2D”). Part 2 of the study will then investigate SON-1010 monotherapy, its use
in combination with atezolizumab, or the standard of care (“SOC”) for PROC in a randomized comparison to show proof-of-concept
(“POC”).
As
part of the ongoing cost-cutting evaluations, all antiviral development with SON-1010 has been suspended.
The
Company acquired the global development rights to its most advanced compound, SON-080, a fully human version of Interleukin 6 (“IL-6”),
in April 2020 through its acquisition of the outstanding shares of Relief Therapeutics SA. Sonnet is advancing SON-080 in target indications
of Chemotherapy-Induced Peripheral Neuropathy (“CIPN”) and Diabetic Peripheral Neuropathy (“DPN”). Sonnet received
approval to initiate an ex-U.S. Phase 1b/2a study with SON-080 in CIPN during the third quarter of 2022. The Data Safety Monitoring Board
(“DSMB”) overseeing the study is expected to meet during the first calendar quarter of 2024. Following the completion of
the DSMB review, Sonnet anticipates announcing initial safety data from the CIPN study. Pursuant to a license agreement the Company entered
into with New Life Therapeutics Pte, Ltd. (“New Life”) of Singapore in May 2021, Sonnet and New Life will be jointly responsible
for developing SON-080 in DPN. The objective will be to analyze the data and to consider initiating a Phase 2 study once the CIPN safety
data has been evaluated.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
SON-1210
(IL12-FHAB-IL15), Sonnet’s lead bifunctional construct, combines FHAB with fully human IL-12 and fully
human Interleukin 15 (“IL-15”). This compound is being developed for solid tumor indications, including colorectal
cancer. In February 2023, the Company announced the successful completion of two IND-enabling toxicology studies with SON-1210
in non-human primates. Sonnet is prepared to initiate the regulatory authorization process for SON-1210 to begin clinical
development pending the outcome of any partnering activity.
SON-1410
(IL18-FHAB-IL12)
is a bifunctional combination of Interleukin 18 (“IL-18”) and IL-12 for solid tumor cancers. Cell line development and process
development are ongoing, with early experimental drug supply suitable for formulation and analytical method development activities. After
some delays in 2023, activities will continue through 2024 with the potential to generate a drug suitable for preclinical studies and
subsequent human studies.
The
Company has completed sequence confirmation for SON-3015 (anti-IL6-FHAB-anti-TGFβ). Early stage bifunctional drug
has been generated and is being stored for future use with in vivo studies in mice. Sonnet has elected to place the SON-3015
development program on hold for expense reduction purposes.
Liquidity
The
Company has incurred recurring losses and negative cash flows from operations since inception and it expects to generate losses from
operations for the foreseeable future primarily due to research and development costs for its potential product candidates. The Company
believes its cash of $3.0 million at December 31, 2023 will fund the Company’s projected operations into March 2024. These
factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim
consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business. The unaudited interim consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
The
Company recently executed an agreement to sell $4.8 million of its New Jersey state net operating losses through the Technology Business
Tax Certificate Transfer Program (the “Program”) for expected net proceeds of $4.3 million, subject to final approval by
the state. Substantial additional financing will be needed by the Company to fund its operations. The Company plans to secure additional
capital in the future through equity or debt financings, partnerships, collaborations, or other sources to carry out the Company’s
planned development activities. If additional capital is not available when required, the Company may need to delay or curtail its operations
until such funding is received. Various internal and external factors will affect whether and when the Company’s product candidates
become approved for marketing and successful commercialization. The regulatory approval and market acceptance of the Company’s
product candidates, length of time and cost of developing and commercializing these product candidates and/or failure of them at any
stage of the approval process will materially affect the Company’s financial condition and future operations.
Operations
since inception have consisted primarily of organizing the Company, securing financing, developing technologies through research and
development and conducting preclinical and clinical studies. The Company faces risks associated with companies whose products are in
development. These risks include the need for additional financing to complete its research and development, achieving its research and
development objectives, defending its intellectual property rights, recruiting and retaining skilled personnel, and dependence on key
members of management.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
2.
Summary of Significant Accounting Policies
a. Basis of presentation
The
accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information as found in the Accounting Standards Codification (“ASC”)
and Accounting Standards Updates (ASUs”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management,
the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily
of accruals, estimates and assumptions that impact the unaudited interim consolidated financial statements) considered necessary to present
fairly the Company’s financial position as of December 31, 2023 and its results of operations and cash flows for the three
months ended December 31, 2023 and 2022. The unaudited interim consolidated financial statements presented herein do not contain the
required disclosures under U.S. GAAP for annual financial statements and should be read in conjunction with the annual audited financial
statements and related notes of Sonnet as of and for the year ended September 30, 2023 included in the Company’s Annual Report
on Form 10-K for the fiscal year ended September 30, 2023. The results of operations for the interim periods are not necessarily indicative
of the results of operations to be expected for the full year.
b. Consolidation
The
unaudited interim consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany
accounts and transactions have been eliminated in consolidation.
c. Use of estimates
The
preparation of the unaudited interim consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Significant estimates
and assumptions reflected in these unaudited interim consolidated financial statements include the accrual of research and development
expenses. Estimates and assumptions are periodically reviewed in-light of changes in circumstances, facts and experience. Changes in
estimates are recorded in the period in which they become known. Actual results could differ from management’s estimates.
d. Incentive tax receivable
Subsidiary
is eligible to participate in an Australian research and development tax incentive program. As part of this program, Subsidiary is eligible
to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by Subsidiary
in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian)
during the reimbursable period. The Company estimates the amount of cash refund it expects to receive related to the Australian research
and development tax incentive program and records the incentive when it is probable (i) the Company will comply with relevant conditions
of the program and (ii) the incentive will be received. As of December 31, 2023, the Company’s estimate of the amount of cash
refund it expects to receive for eligible spending related to the Australian research and development tax incentive program was $0.2 million.
For the three months ended December 31, 2023 and 2022, $0.2 million and $0.3 million, respectively, for the expected cash refund related
to the tax incentive program was included as an offset to research and development expenses. In December 2023, the Company received $0.8
million from the Australian government related to eligible research and development expenses for the year ended September 30, 2023.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
e. Property and equipment
Property
and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Expenditures
for repairs and maintenance that do not extend the estimated useful life or improve an asset are expensed as incurred. Upon retirement
or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts, and any
resulting gain or loss is included in the consolidated statement of operations.
f. Collaboration revenue
Collaboration
arrangements may contain multiple components, which may include (i) licenses; (ii) research and development activities; and (iii) the
manufacturing and supply of certain materials. Payments pursuant to these arrangements may include non-refundable payments, upfront payments,
milestone payments upon the achievement of significant regulatory and development events, sales milestones and royalties on product sales.
The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in
a future period.
In
determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under a collaboration arrangement,
the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of
whether the promised goods or services are performance obligations, including whether they are capable of being distinct; (iii) measurement
of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance
obligations; and (v) recognition of revenue as the Company satisfies each performance obligation.
The
Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating
transaction price to performance obligations within a contract, determining when performance obligations have been met, and assessing
the recognition of variable consideration. When consideration is received prior to the Company completing its performance obligation
under the terms of a contract, a contract liability is recorded as deferred income. Deferred income expected to be recognized as revenue
within the twelve months following the balance sheet date is classified as a current liability. In May 2021, the Company entered into
a License Agreement (the “New Life Agreement”) with New Life. See Note 5 for
further discussion of the New Life Agreement.
g. Research and development expense
Research
and development expenses include all direct and indirect costs associated with the development of the Company’s biopharmaceutical
products. These expenses include personnel costs, consulting fees, and payments to third parties for research, development, and manufacturing
services. These costs are charged to expense as incurred.
At
the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward
completion of the related project, based on the measure of progress as defined in the contract. Factors the Company considers in preparing
the estimates include costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of its service
providers. Such estimates are subject to change as additional information becomes available. Depending on the timing of payment to the
service providers and the progress that the Company estimates has been made as a result of the service provided, the Company will record
a prepaid expense or accrued liability relating to these costs. Upfront milestone payments made to third parties who perform research
and development services on the Company’s behalf are expensed as services are rendered. Contingent development or regulatory milestone
payments are recognized upon the related resolution of such contingencies.
h. Reverse stock split
On
August 31, 2023, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary of
State of the State of Delaware, which effected a 1-for-22 reverse stock split of the Company’s issued and outstanding shares of
common stock. As a result of the reverse stock split, every 22 shares of common stock issued and outstanding was converted into one share
of common stock. The reverse stock split affected all stockholders uniformly and did not alter any stockholder’s percentage interest
in the Company’s equity. No fractional shares were issued in connection with the reverse stock split. Stockholders who would otherwise
be entitled to a fractional share of common stock were instead entitled to receive a proportional cash payment. The reverse stock split
did not change the par value or authorized number of shares of common stock. All common share and per share amounts presented in the
unaudited interim consolidated financial statements and accompanying notes have been retroactively adjusted to reflect the reverse stock
split.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
i. Net loss per share
Basic
net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each
period (and potential shares of common stock that are exercisable for little or no consideration). Included in basic weighted-average
number of shares of common stock outstanding during the three months ended December 31, 2023 are the pre-funded October 2023 warrants
to purchase 1,537,500 shares of common stock with an exercise price of $0.0001 per share. Included in basic weighted-average number of
shares of common stock outstanding during the three months ended December 31, 2022 are the Series B warrants to purchase 137 shares
of common stock with an exercise price of $0.0308 per share, which were net share settled in November 2022.
Diluted
loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and
stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average
number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities
are not included in the calculation as the impact is anti-dilutive.
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule of Potentially Dilutive Securities
| |
2023 | | |
2022 | |
| |
December
31, | |
| |
2023 | | |
2022 | |
Common stock warrants August 2021 | |
| 112,429 | | |
| 128,500 | |
Underwriter warrants August 2021 | |
| 2,287 | | |
| 2,287 | |
Private warrants | |
| — | | |
| 90 | |
Chanticleer warrants | |
| 57 | | |
| 57 | |
Series C warrants | |
| 18,391 | | |
| 36,778 | |
Series 3 warrants | |
| 12,548 | | |
| 12,548 | |
Unvested restricted stock units and awards | |
| 7,840 | | |
| 10,002 | |
Common stock warrants February 2023 | |
| 271,883 | | |
| — | |
Underwriter warrants February 2023 | |
| 15,466 | | |
| — | |
Common stock private placement warrants June
2023 | |
| 227,272 | | |
| — | |
Placement agent warrants June 2023 | |
| 6,818 | | |
| — | |
Common stock warrants October 2023 | |
| 5,687,500 | | |
| — | |
Underwriter warrants October 2023 | |
| 85,312 | | |
| — | |
Total anti-dilutive weighted
average shares | |
| 6,447,803 | | |
| 190,262 | |
j. Recent accounting pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU
2023-07, which is applicable to entities with a single reportable segment, will primarily require enhanced disclosures about significant
segment expenses and enhanced disclosures in interim periods. The guidance in ASU 2023-07 will be applied retrospectively and is effective
for annual reporting periods in fiscal years beginning after December 15, 2023 and interim reporting periods in fiscal years beginning
after December 31, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-07
will have on its consolidated financial statements and disclosures.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 is intended
to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the
rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the
income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning
after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated
financial statements and disclosures.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
3.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following:
Schedule of Accrued Expenses and Other Current Liabilities
| |
December 31, | | |
September
30, | |
| |
2023 | | |
2023 | |
Compensation and benefits | |
$ | 141,636 | | |
$ | 2,091,196 | |
Research and development | |
| 564,674 | | |
| 913,145 | |
Professional fees | |
| 213,912 | | |
| 224,031 | |
Other | |
| 2,969 | | |
| 2,550 | |
Accrued expenses and
other current liabilities | |
$ | 923,191 | | |
$ | 3,230,922 | |
During
the current period, the Company cancelled accrued but unpaid bonuses that had been awarded for fiscal years 2022 and 2023, which has
been accounted for as a change in estimate. The cancellation of bonuses reduced research and development expenses by $1.0 million and
general and administrative expenses by $0.9 million for the three months ended December 31, 2023.
4.
Commitments and Contingencies
Legal
proceedings
From
time to time, the Company is a party to various lawsuits, claims, and other legal proceedings that arise in the ordinary course of its
business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters
will have a material adverse effect on the Company’s consolidated financial position, results of operations, or cash flows.
License
agreements
In
July 2012, the Company entered into a Discovery Collaboration Agreement (the “Collaboration Agreement”) with XOMA (US) LLC
(“XOMA”), pursuant to which XOMA granted to the Company a non-exclusive, non-transferable license and/or right to use certain
materials, technologies and related information for the discovery, optimization and development of antibodies and related proteins
and to develop and commercialize products thereunder. The Company is obligated to make contingent milestone payments to XOMA totaling
$3.8 million on a product-by-product basis upon the achievement of certain development and approval milestones related to a product.
The Company has also agreed to pay XOMA low single-digit royalties on net sales of products sold by the Company. Royalties on each product
are payable on a country-by-country basis until the later of (i) a specified period of time after the first commercial sale, and (ii)
the date of expiration of the last valid claim in the last-to-expire of the issued patents covered by the Collaboration Agreement. The
first milestone was achieved in April 2022, at which time the Company incurred a $0.5 million license fee which was recorded as acquired
in-process research and development. No license fees were incurred during the three months ended December 31, 2023 and 2022.
In
August 2015, the Company entered into a License Agreement (the “ARES License Agreement”) with Ares Trading, a wholly-owned
subsidiary of Merck KGaA (“ARES”). Under the terms of the ARES License Agreement, ARES has granted the Company a sublicensable,
exclusive, worldwide, royalty-bearing license on proprietary patents to research, develop, use and commercialize products using atexakin
alfa (“Atexakin”), a low dose formulation of human IL-6 in peripheral neuropathies and vascular complications. Pursuant to
the ARES License Agreement, the Company will pay ARES mid single-digit royalties on net sales of products sold by the Company. Royalties
are payable on a product-by-product and country-by-country basis until the later of (i) a specified period of time after the first commercial
sale in such country, and (ii) the last date on which such product is covered by a valid claim in such country.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In
January 2019, the Company entered into a Frame Services and License Agreement (the “Cellca Agreement”) with Sartorius Stedim
Cellca GMBH (“Cellca”), pursuant to which Cellca has granted the Company a worldwide, non-exclusive, perpetual, non-transferable
license to develop, manufacture or have manufactured, use, sell, import, export and/or otherwise commercialize product based on Cellca’s
work to generate a specified transfected cell line and develop an upstream production process for such cell line. The Cellca Agreement
is effective unless terminated by either party by giving six months notice, or by giving 14 days notice if terminated for good cause.
The Company is obligated to make milestone payments to Cellca totaling up to $0.7 million upon the achievement of certain development
and approval milestones if the Buy-Out Option is not exercised. The Company has a Buy-Out Option that will be effective between the time
of completion of a clinical trial and the receipt of regulatory approval for commercialization of product. The cost to exercise the Buy-Out
Option increases on each anniversary of the commencement date of the Buy-Out Option Period, and ranges from $0.1 million to $0.6 million.
The cost to exercise the Buy-Out Option will replace the $0.6 million contingent milestone payment due upon final regulatory approval.
The first milestone was achieved in April 2022, at which time the Company incurred a $0.1 million license fees which was recorded as
acquired in-process research and development. No license fees were incurred during the three months ended December 31, 2023 and 2022.
In
October 2021, the Company entered into a Non-Exclusive License Agreement (the “Brink Agreement”) with Brink Biologics Inc.
(“Brink”), pursuant to which Brink has granted the Company a non-exclusive, non-transferable license and limited right to
sublicense certain materials and related information to develop cell-based assays for batch, quality control, stability, efficacy, potency
or any other type of assay required for production and commercialization of products. During the product development phase, the Company
was obligated to make annual product development license fee payments of approximately $0.1 million. In April 2023, the Brink Agreement
was amended, effective November 2022, to reduce the annual license fee payments to $12,000 for storage. If materials are removed from
storage during the product development phase, the annual product development license fee of approximately $0.1 million will apply. If
a product achieves commercial status, the Company is obligated to make a commercial product license fee payment of approximately $0.1
million per commercial product. The amended agreement has an initial term of one year and will automatically renew for one additional
year unless terminated or converted to a product development license. After the second year, the license will automatically convert to
a full license requiring a product development or a commercial product license fee unless the parties mutually agree to terminate the
agreement. The Company incurred $12,000 in license fees during the three months ended December 31, 2023, which were recorded as
acquired in-process research and development and included in research and development expenses in the unaudited interim consolidated
statement of operations. No license fees were incurred during the three months ended December 31, 2022.
In
February 2022, the Company entered into a Biological Materials License Agreement (the “InvivoGen Agreement”) with InvivoGen
SAS (“InvivoGen”), pursuant to which InvivoGen has granted the Company a worldwide, non-exclusive license to use certain
reporter cells for research, development and/or quality control purposes. The InvivoGen Agreement has an initial term of three years
and may be extended for two additional three-year periods upon written notice by the Company and payment of an approximately €0.1
million fee per extension (approximately $0.1 million as of December 31, 2023). No license fees were incurred during the three months
ended December 31, 2023 and 2022.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In
March 2022, the Company entered into a Material Transfer and License Agreement (the “ProteoNic Agreement”) with
ProteoNic B.V. (“ProteoNic”), pursuant to which ProteoNic has granted to the Company a non-exclusive, non-transferable,
non-sublicensable (except as provided for in the ProteoNic Agreement) license for certain materials, including plasmids and DNA
sequences used to generate the vectors used in the Company’s cell lines, for the Company’s use in research, development
and commercialization of product. The license will continue until terminated by either party. The Company incurred a $24,600
license fee upon obtaining the license. The Company was obligated to make contingent milestone payments to ProteoNic totaling up to
€1.2
million (approximately $1.3
million as of December 31, 2023) upon the achievement of certain development and commercialization milestones as outlined in
the ProteoNic Agreement. No
license fees were incurred during the three months ended December 31, 2023 and 2022. In January 2024, the Company terminated the
ProteoNic Agreement and has no further obligations under the arrangement.
Research
and development agreement
In
December 2021, the Company entered into a Research and Development Agreement (the “Navigo Agreement”), as subsequently amended,
with Navigo Proteins GmbH (“Navigo”), pursuant to which Navigo will perform specified evaluation and development procedures
to evaluate certain materials to determine their commercial potential. Under the terms of the Navigo Agreement, the Company has granted
Navigo a royalty-free, non-exclusive, worldwide, non-sublicensable, non-transferable right and license to use certain technology to perform
the evaluation and development activities, and Navigo has granted the Company (i) an exclusive, worldwide, perpetual, irrevocable, sublicensable,
transferable, royalty-free right and license to research, develop, use, sell, have sold, distribute, import or otherwise commercially
exploit certain materials, and (ii) a non-exclusive, worldwide, perpetual, sublicensable, non-transferable right and license to make
or have made such materials. The Company incurred a $0.1 million technology access fee upon execution of the Navigo Agreement, at which
time it was recorded as acquired in-process research and development. The Company is obligated to make contingent milestone payments
to Navigo, totaling up to $1.0 million upon the achievement of certain evaluation and development milestones as outlined in the Navigo
Agreement. Certain evaluation milestones were achieved in 2023, including $0.1 million in license
fees which were recorded as acquired in-process research and development and included as research and development expenses in the unaudited
interim consolidated statement of operations for the three months ended December 31, 2022. No milestones were achieved and no license
fees were incurred during the three months ended December 31, 2023.
Employment
agreements
The
Company has entered into employment contracts with its officers and certain employees that provide for severance and continuation of
benefits in the event of termination of employment either by the Company without cause or by the employee for good reason, both as defined
in the contract. In addition, in the event of termination of employment following a change in control, as defined, either by the Company
without cause or by the employee for good reason, any unvested portion of the employee’s initial stock option grant becomes immediately
vested.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
5.
Collaboration Revenue
Under
the New Life Agreement, the Company granted New Life an exclusive license (with the right to sublicense) to develop and commercialize
pharmaceutical preparations containing a specific recombinant human IL-6, SON-080 (the “Compound”) (such preparations, the
“Products”) for the prevention, treatment or palliation of diabetic peripheral neuropathy in humans (the “DPN Field”)
in Malaysia, Singapore, Indonesia, Thailand, Philippines, Vietnam, Brunei, Myanmar, Lao PDR and Cambodia (the “Exclusive Territory”).
New Life had the option to expand (1) the field of the exclusive license to include the prevention, treatment or palliation of chemotherapy-induced
peripheral neuropathy in humans (the “CIPN Field”), which option was non-exclusive and expired on December 31, 2021; and/or
(2) the territorial scope of the license to include the People’s Republic of China, Hong Kong and/or India, which option was exclusive
and expired on December 31, 2021.
The
Company will retain all rights to manufacture Compounds and Products anywhere in the world. The Company and New Life shall enter into
a follow-on supply agreement pursuant to which the Company shall supply to New Life Products for development and commercialization thereof
in the DPN Field in the Exclusive Territory on terms to be negotiated by the parties. The Company will also assist in transferring certain
preclinical and clinical development know-how that is instrumental in New Life’s ability to benefit from the license.
New
Life will bear the cost of, and be responsible for, among other things, conducting clinical studies and additional non-clinical studies
and other developmental and regulatory activities for and commercializing Products in the DPN Field in the Exclusive Territory.
New
Life paid the Company a $0.5 million non-refundable upfront cash payment in August 2020 upon executing a letter of intent to negotiate
a license agreement and a $0.5 million non-refundable upfront cash payment in June 2021 in connection with the execution of the New Life
Agreement. New Life is also obligated to pay a non-refundable deferred license fee of an additional $1.0 million at the time of the satisfaction
of certain milestones, as well as potential additional milestone payments to the Company of up to $19.0 million subject to the achievement
of certain development and commercialization milestones. In addition, during the Royalty Term (as defined below), New Life is obligated
to pay the Company tiered double-digit royalties ranging from 12% to 30% based on annual net sales of Products in the Exclusive Territory.
The “Royalty Term” means, on a Product-by-Product and a country-by-country basis in the Exclusive Territory, the period commencing
on the date of the first commercial sale (subject to certain conditions) of such Product in such country in the Exclusive Territory and
continuing until New Life ceases commercialization of such Product in the DIPN Field.
The
New Life Agreement will remain in effect on a Product-by-Product, country-by-country basis and will expire upon the expiration of the
Royalty Term for the last-to-expire Product in the last-to-expire country, subject to (i) each party’s early termination rights
including for material breach or insolvency or bankruptcy of the other party and (ii) the Company’s Buy Back Right and New Life’s
Give Back Right (as defined below).
In
addition, New Life granted to the Company an exclusive option to buy back the rights granted by the Company to New Life and the Company
granted New Life the right to give back the rights with respect to Products in the DPN Field in one or more countries in the Exclusive
Territory on terms to be agreed upon, which options will expire upon the initiation of a Phase III Trial for the applicable Product.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Revenue
recognition
The
Company first assessed the New Life Agreement under ASC 808, Collaborative Arrangements (“ASC 808”), to determine
whether the New Life Agreement or units of accounts within the New Life Agreement represent a collaborative arrangement based on the
risks and rewards and activities of the parties. The Company applied relevant guidance from ASC 606, Revenue from Contracts with Customers
(“ASC 606”), to evaluate the appropriate accounting for the collaborative arrangement with New Life. In accordance with
this guidance, the Company identified the following obligations under the arrangement: (i) License to develop, market, import, use and
commercialize the Product in the Field in the Exclusive Territory (the “License”); and (ii) transfer of know-how and clinical
development and regulatory activities (“R&D Activities”). The options to expand the CIPN Field and territory as well
as the future supply agreement represent optional purchases, which are accounted for as separate contracts. The Company evaluated these
separate contracts and did not identify any material right to be present. The Company determined that License and the R&D services
are not distinct from each other and therefore combined these material promises into a single performance obligation.
The
Company determined the initial transaction price of the single performance obligation to be $1.0 million, as the future development and
commercialization milestones, which represent variable consideration, are subject to constraint at inception. At the end of each subsequent
reporting period, the Company will reevaluate the probability of achievement of the future development and commercialization milestones
subject to constraint and, if necessary, will adjust its estimate of the overall transaction price. Any such adjustments will be recorded
on a cumulative catch-up basis. For the sales-based royalties, the Company will recognize revenue when the related sales occur.
Collaboration
revenue from the single performance obligation is being recognized over the estimated performance of the R&D services. The Company
recognized $18,626 and $37,255 of collaboration revenue for the three months ended December 31, 2023 and 2022, respectively.
6.
Stockholders’ Deficit
On
October 26, 2023, the Company closed a public offering of common stock and certain warrants through Chardan Capital Markets, LLC and
Ladenburg Thalmann & Co. Inc. as underwriters, for net proceeds of $3.9 million through the issuance and sale of 1,306,250 shares
of its common stock and, to certain investors, pre-funded warrants to purchase 1,537,500 shares of common stock, and accompanying common
warrants to purchase up to an aggregate of 5,687,500 shares of its common stock. Each share of common stock and pre-funded warrant to
purchase one share of common stock was sold together with a common warrant to purchase two shares of common stock. The public offering
price of each share of common stock and accompanying common warrant was $1.60 and the public offering price of each pre-funded warrant
and accompanying common warrant was $1.5999. The common warrants are immediately exercisable at a price of $1.60 per share of common
stock, expire five years from the date of issuance and contain an alternative cashless exercise provision. The pre-funded warrants are
immediately exercisable at any time, until exercised in full, at a price of $0.0001 per share of common stock. In addition, warrants
to purchase 85,312 shares of common stock were issued to the underwriters as compensation for their services related to the offering.
These common stock warrants have an exercise price of $2.00 per share and expire five years from the date of issuance.
The
Company entered into an At-the-Market Sales Agreement with BTIG, LLC (“BTIG”) on August 15, 2022 (the “2022 Sales Agreement”).
Pursuant to the 2022 Sales Agreement, the Company could offer and sell, from time to time, through BTIG, as sales agent and/or principal,
shares of its common stock having an aggregate offering price of up to $25.0 million, subject to certain limitations on the amount of
common stock that may be offered and sold by the Company set forth in the 2022 Sales Agreement. Due to the offering limitations applicable
to the Company, the Company filed prospectus supplements for the sale of shares of its common stock for an aggregate offering price of
up to $7.8 million pursuant to the 2022 Sales Agreement. During the three months ended December 31, 2022, the Company sold 109,841
shares of common stock pursuant to the 2022 Sales Agreement for gross proceeds of $4.8 million and net proceeds of $4.5 million. There
are no registered shares remaining to be sold under the 2022 Sales Agreement.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Common
stock warrants
As
of December 31, 2023, the following equity-classified warrants and related terms were outstanding:
Schedule of Warrants Outstanding
| |
Warrants
Outstanding | | |
Exercise
Price | | |
Expiration
Date |
Common stock warrants August 2021 | |
| 112,429 | | |
$ | 261.80 | | |
August 24, 2026 |
Underwriter warrants August 2021 | |
| 2,287 | | |
$ | 327.25 | | |
August 19, 2026 |
Chanticleer warrants | |
| 57 | | |
$ | 18,018.00
- 28,028.00 | | |
April 30, 2027 - December 17, 2028 |
Series C warrants | |
| 18,391 | | |
$ | 982.52 | | |
October 16, 2025 |
Series 3 warrants | |
| 12,548 | | |
$ | 89.628 | | |
August 15, 2027 |
Common stock warrants February 2023 | |
| 271,883 | | |
$ | 23.76 | | |
February 10, 2028 |
Underwriter warrants February 2023 | |
| 15,466 | | |
$ | 29.70 | | |
February 8, 2028 |
Common stock private placement warrants June
2023 | |
| 227,272 | | |
$ | 14.8478 | | |
December 30, 2026 |
Placement agent warrants June 2023 | |
| 6,818 | | |
$ | 14.8478 | | |
December 30, 2026 |
Common stock warrants October 2023 | |
| 5,687,500 | | |
$ | 1.60 | | |
October 27, 2028 |
Pre-funded warrants October 2023 | |
| 1,537,500 | | |
$ | 0.0001 | | |
— |
Underwriter warrants October 2023 | |
| 85,312 | | |
$ | 2.00 | | |
October 24, 2028 |
Total | |
| 7,977,463 | | |
| | | |
|
During
the three months ended December 31, 2023, 28,724 of
warrants were net share settled, resulting in the issuance of 14,362 shares of common stock, and 34,458 of warrants were abandoned by
the warrant holder.
During
the three months ended December 31, 2022, 137 of warrants were net share settled, resulting in the issuance of 137 shares of common stock,
and 242 of warrants expired.
7.
Share-Based Compensation
In
April 2020, the Company adopted the 2020 Omnibus Equity Incentive Plan (the “Plan”). On
January 1, 2024, the total number of shares authorized under the Plan increased to 122,780. There were 14,480 shares available
for issuance under the Plan as of December 31, 2023. The Plan increases the amount of shares issuable under the Plan by four
percent of the outstanding shares of common stock at each January 1, each year. The Plan permits the granting of share-based awards,
including stock options, restricted stock units and awards, stock appreciation rights and other types of awards as deemed appropriate,
in each case, in accordance with the terms of the Plan. The terms of the awards are determined by the Company’s Board of Directors.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Restricted
stock units and awards
Any
unvested restricted stock units (“RSUs”) or restricted stock awards (“RSAs”) will be forfeited upon termination
of services. The fair value of an RSU or RSA is equal to the fair market value of the Company’s common stock on the date of grant.
RSU and RSA expense is amortized straight-line over the vesting period.
The
Company recorded share-based compensation expense associated with the RSUs and RSAs in its accompanying unaudited interim consolidated
statements of operations as follows:
Schedule of Share-based Compensation Expense
| |
2023 | | |
2022 | |
| |
Three
Months Ended December 31, | |
| |
2023 | | |
2022 | |
Research and development | |
$ | 24,554 | | |
$ | 46,708 | |
General and administrative | |
| 25,451 | | |
| 44,909 | |
Share Based Compensation | |
$ | 50,005 | | |
$ | 91,617 | |
The
following table summarizes RSU activity under the Plan:
Schedule of Restricted Stock Units Activity
| |
| | |
Weighted | |
| |
| | |
Average Grant | |
| |
RSU | | |
Date
Fair Value | |
Unvested balance at December
31, 2023 | |
| 2,326 | | |
$ | 21.78 | |
During
the three months ended December 31, 2023, there were no RSUs granted, vested or forfeited. As of December 31, 2023, there is
no remaining unrecognized compensation expense as the RSUs vested on January 1, 2024.
On
January 1, 2024, 73,440 RSUs were granted, 100% of which vest on January 1, 2025.
The
following table summarizes RSA activity under the Plan:
Schedule of Restricted Stock Awards Activity
| |
| | |
Weighted | |
| |
| | |
Average Grant | |
| |
RSA | | |
Date
Fair Value | |
Unvested balance at December
31, 2023 | |
| 5,514 | | |
$ | 28.27 | |
During
the three months ended December 31, 2023, there were no RSAs granted, vested or forfeited. As of December 31, 2023, there is
no remaining unrecognized compensation expense as the RSAs vested on January 1, 2024.
On
January 1, 2024, 63,819 RSAs were granted, 100% of which vest on January 1, 2025.
8.
Income Taxes
In
August 2022, the U.S. enacted the Inflation Reduction Act of 2022 (“IRA”). The IRA contains a number of tax-related provisions
that will be effective for tax years beginning after December 31, 2022, including a corporate alternative minimum tax of 15% on certain
large corporations and an excise tax of 1% on corporate stock repurchases. The Company is currently evaluating the various provisions
of the IRA and does not anticipate a material impact on its consolidated financial statements.
9.
Subsequent Events
The
Company has evaluated subsequent events from the balance sheet date through February 14, 2024, the date at which the unaudited interim
consolidated financial statements were available to be issued.
In
January 2024, the Company executed an agreement to sell $4.8 million of its New Jersey state net operating losses through the Program
for expected net proceeds of $4.3 million.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results Of Operations.
The
following discussion and analysis of our financial condition and results of operations should be read together with our financial statements
and the related notes and the other financial information included elsewhere in this Quarterly Report. This discussion contains forward-looking
statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking
statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report, particularly those
under “Risk Factors.”
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations,
assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which
may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future
results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of
historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our
use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,”
“would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,”
“continue,” “plan,” “point to,” “project,” “predict,” “could,”
“intend,” “target,” “potential” and other similar words and expressions of the future.
There
are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking
statement made by us. These factors include, but are not limited to:
| ● | our
lack of operating history and history of operating losses; |
| ● | our
need for significant additional capital and our ability to satisfy our capital needs; |
| ● | our
ability to complete required clinical trials of our products and obtain approval from the
FDA or other regulatory agents in different jurisdictions; |
| ● | our
ability to maintain or protect the validity of our patents and other intellectual property; |
| ● | our
ability to retain key executive members; |
| ● | our
ability to internally develop new inventions and intellectual property; |
| ● | interpretations
of current laws and the passages of future laws; |
| ● | acceptance
of our business model by investors; |
| ● | the
potential impact of the recent COVID-19 pandemic or the widespread outbreak of any other
communicable disease on our operations, including on our clinical development plans and timelines; |
| ● | the
accuracy of our estimates regarding expenses and capital requirements; and |
| ● | our
ability to adequately support growth. |
The
foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or
risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements.
Please see “Risk Factors” for additional risks which could adversely impact our business and financial performance.
All
forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue
reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by
reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking
statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections
in good faith and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections
will result or be achieved or accomplished.
Overview
Sonnet
BioTherapeutics Holdings, Inc. (“Sonnet,” “we,” “us,” “our” or the “Company”),
is a clinical stage, oncology-focused biotechnology company with a proprietary platform for innovating biologic medicines with single or
bifunctional action. Known as FHAB™ (Fully Human Albumin Binding), the technology utilizes a fully human single chain
antibody fragment that binds to and “hitch-hikes” on human serum albumin for transport to target tissues. We designed the
construct to improve drug accumulation in specific tissues, as well as to extend the duration of activity in the body. FHAB
development candidates are produced in a mammalian cell culture, which enables glycosylation, thereby reducing the risk of immunogenicity.
We believe our FHAB technology, for which we received a U.S. patent in June 2021, is a distinguishing feature of our biopharmaceutical
platform that is well suited for future drug development across a range of human disease areas, including in oncology, autoimmune, pathogenic,
inflammatory, and hematological conditions.
Our
current internal pipeline development activities are focused on cytokines, a class of cell signaling peptides that, among other important
functions, serve as potent immunomodulatory agents. Working both independently and synergistically, specific cytokines have shown the
ability to modulate the activation and maturation of immune cells that fight cancer and pathogens. However, because they do not preferentially
accumulate in specific tissues and are quickly eliminated from the body, the conventional approach to achieving a treatment effect with
cytokine therapy typically requires the administration of high and frequent doses. This can result in a reduced treatment effect accompanied
by the potential for systemic toxicity, which poses challenges to the therapeutic application of this class of drugs.
Our
lead proprietary asset, SON-1010, is a fully human single chain version of Interleukin 12 (“IL-12”), covalently linked
to the FHAB construct, for which we are pursuing clinical development in solid tumor indications, including ovarian
cancer, non-small cell lung cancer and head and neck cancer. In March 2022, the FDA cleared our Investigational New Drug
(“IND”) application for SON-1010. This allowed us to initiate a U.S. clinical trial (SB101) in oncology patients with
solid tumors during the second calendar quarter of 2022. In September 2021, we created a wholly-owned Australian subsidiary,
SonnetBio Pty Ltd (“Subsidiary”), for the purpose of conducting certain clinical trials in that country. We received approval and
initiated an Australian clinical study (SB102) of SON-1010 in healthy volunteers during the third calendar quarter of 2022. Interim
safety and tolerability data from the SB101 and SB102 studies were reported in April 2023.
In
January 2023, we announced a collaboration agreement with Roche for the clinical evaluation of SON-1010 with atezolizumab
(Tecentriq®). The companies have entered into a Master Clinical Trial and Supply Agreement (“MCSA”), along with
ancillary Quality and Safety Agreements, to study the safety and efficacy of the combination of SON-1010 and atezolizumab in a
platinum-resistant ovarian cancer (“PROC”) patient setting. Furthermore, the companies will provide SON-1010 and
atezolizumab, respectively, for use in the Phase 1b/Phase 2a combination safety, dose-escalation, and efficacy study (SB221). Part 1
of this 2-part study was approved in June 2023 by the local Human Research Ethics Committee in Australia under CT-2023-CTN-01399-1
and the Therapeutic Goods Administration has been notified. In August 2023, the FDA accepted the IND for SON-1010 in this indication. The trial consists
of a modified 3+3 dose-escalation design in Part 1 to establish the maximum tolerated dose (“MTD”) of SON-1010 with a
fixed dose of atezolizumab. Clinical benefit in PROC will be confirmed in an expansion group to establish the recommended Phase 2
dose (“RP2D”). Part 2 of the study will then investigate SON-1010 monotherapy, its use in combination with atezolizumab,
or the standard of care (‘SOC”) for PROC in a randomized comparison to show proof-of-concept
(“POC”).
We
acquired the global development rights to our most advanced compound, SON-080, a fully human version of Interleukin 6 (“IL-6”),
in April 2020 through our acquisition of the outstanding shares of Relief Therapeutics SA. We are advancing SON-080 in target indications
of Chemotherapy-Induced Peripheral Neuropathy (“CIPN”) and Diabetic Peripheral Neuropathy (“DPN”). We received
approval to initiate an ex-U.S. Phase 1b/2a study with SON-080 in CIPN. Enrollment of the first portion of the SB211 study in chemotherapy-induced
peripheral neuropathy (CIPN) is nearing completion, which should position the Data Safety Monitoring Board to complete its review of
the preliminary safety data during the first calendar quarter of 2024. Pursuant to a license agreement we entered into with New Life
Therapeutics Pte, Ltd. (“New Life”) of Singapore in May 2021, Sonnet and New Life will be jointly responsible for developing
SON-080 in DPN. The objective will be to analyze the data and to consider initiating a Phase 2 study, once the CIPN safety data has been
evaluated.
SON-1210
(IL12-FHAB-IL15), our lead bifunctional construct, combines FHAB with fully human IL-12 and fully human Interleukin
15 (“IL-15”). This compound is being developed for solid tumor indications, including colorectal cancer. In February 2023,
we announced the successful completion of two IND-enabling toxicology studies with SON-1210 in non-human primates. We are prepared to
initiate the regulatory authorization process for SON-1210, pending the outcome of any partnering activity.
SON-1410
(IL18-FHAB-IL12) is a bifunctional combination of Interleukin 18 (“IL-18”) and IL-12 for solid tumor cancers. Cell
line development and process development are ongoing, with early experimental drug supply suitable for formulation and analytical method
development activities. After some delays in 2023, activities will continue through 2024 with the potential to generate a drug suitable
for preclinical studies and subsequent human studies.
We
have completed sequence confirmation for SON-3015 (anti-IL6-FHAB-anti-TGFβ). Early stage bifunctional drug has been generated
and is being stored for future use with in vivo studies in mice. We have elected to place the SON-3015 development program on hold
for expense reduction purposes.
As
part of the ongoing cost-cutting evaluations, all antiviral development with SON-1010 has been suspended.
We
have incurred recurring operating losses and negative cash flows since inception. Our ability to generate product or licensing revenue
sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of
our current or future product candidates. Our net losses were $1.2 million and $5.5 million for the three months ended December 31, 2023
and 2022, respectively. As of December 31, 2023, we had cash of $3.0 million. We expect to continue to incur significant expenses
and increasing operating losses for at least the next several years. We expect that our expenses and capital requirements will increase
substantially in connection with our ongoing activities, particularly if and as we:
| ● | conduct
additional clinical trials for product candidates; |
| ● | continue
to discover and develop additional product candidates; |
| ● | acquire
or in-license other product candidates and technologies; |
| ● | maintain,
expand and protect our intellectual property portfolio; |
| ● | hire
additional clinical, scientific and commercial personnel; |
| ● | establish
a commercial manufacturing source and secure supply chain capacity sufficient to provide
commercial quantities of any product candidates for which we may obtain regulatory approval; |
| ● | seek
regulatory approval for product candidates that successfully complete clinical trials; |
| ● | establish
a sales, marketing and distribution infrastructure to commercialize any products for which
we may obtain regulatory approval; and |
| ● | add
operational, financial and management information systems and personnel, including personnel
to support our product development and planned future commercialization efforts, as well
as to support our operation as a public reporting company. |
We
will not generate revenue from product sales, if any, unless and until we receive licensing revenue and/or successfully complete clinical
development and obtain regulatory approval for our product candidates. If we obtain regulatory approval for any of our product candidates
and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our internal commercialization
capability to support product sales, marketing and distribution. We will continue to incur significant costs associated with operating
as a public company.
As
a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such
time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity,
debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. We may
not be able to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all.
If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate
the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.
Because
of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased
expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not
become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis or raise additional capital
or enter into collaboration or license agreements, then we may be unable to continue our operations at planned levels and be forced to
reduce or terminate operations.
Since
our inception in 2015, we have devoted substantially all of our efforts and financial resources to organizing and staffing the Company,
business planning, raising capital, acquiring or discovering product candidates and securing related intellectual property rights and
conducting discovery, research and development activities for product candidates. We do not have any products approved for sale and have
not generated any revenue from product sales. We have funded our operations to date primarily with proceeds from sales of common stock,
warrants and proceeds from the issuance of convertible debt.
Components
of Results of Operations
Collaboration
Revenue
Collaboration
revenue is currently earned from the license arrangement entered into with New Life in May 2021, which granted New Life rights to an
exclusive license (with the right to sublicense) to develop and commercialize pharmaceutical preparations containing a specific recombinant
human IL-6, SON-080 (the “Compound”) (such preparations, the “Products”) for the prevention, treatment or palliation
of diabetic peripheral neuropathy in humans (the “DPN Field”) in the Exclusive Territory. We identified the following obligations
under the arrangement: (i) License to develop, market, import, use and commercialize the Product in the Field in the Exclusive Territory
(the “License”); and (ii) transfer of know-how and clinical development and regulatory activities (“R&D Activities”).
We determined that the License and the R&D Activities are not distinct from each other and, therefore, combined these material promises
into a single performance obligation. Under this agreement, we received upfront cash payments totaling $1.0 million, which were fully
allocated to the single performance obligation and are being recognized over the estimated performance period of R&D services.
Operating
Expenses
Research
and Development Expenses
Research
and development expenses consist primarily of costs incurred in connection with the discovery and development of our product candidates.
We expense research and development costs as incurred and such costs include:
| ● | employee-related
expenses, including salaries, share-based compensation and related benefits, for employees
engaged in research and development functions; |
| ● | expenses
incurred in connection with the preclinical and clinical development of our product candidates,
including under agreements with third parties, such as consultants and clinical research
organizations; |
| ● | the
cost of manufacturing drug products for use in our preclinical studies and clinical trials,
including under agreements with third parties, such as consultants and contract manufacturing
organizations; |
| ● | facilities,
depreciation and other expenses, which include direct or allocated expenses for rent and
maintenance of facilities and insurance; |
| ● | costs
related to compliance with regulatory requirements; and |
| ● | payments
made under third-party licensing agreements. |
We
recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided
by our service providers. This process involves reviewing open contracts and purchase orders, communicating with their personnel to identify
services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the
service when we have not yet been invoiced or otherwise notified of actual costs. Nonrefundable advance payments for goods or services
to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized
as an expense when the goods have been delivered or the services have been performed.
Our
direct research and development expenses consist primarily of external costs, such as fees paid to outside consultants, CROs, CMOs and
research laboratories in connection with preclinical development, process development, manufacturing and clinical development activities.
Our direct research and development expenses also include fees incurred under third-party license agreements. We do not allocate employee
costs and costs associated with discovery efforts, laboratory supplies and facilities, including depreciation or other indirect costs,
to specific product candidates because these costs are deployed across multiple programs and as such, are not separately classified.
We use internal resources primarily to conduct our research and discovery as well as for managing preclinical development, process development,
manufacturing and clinical development activities. These employees work across multiple programs and therefore, we do not track costs
by product candidate.
We
will continue to incur research and development expenses for the foreseeable future as we attempt to advance development of our product
candidates. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or
know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of our current pipeline
or any future product candidates we may develop due to the numerous risks and uncertainties associated with clinical development, including
risk and uncertainties related to:
| ● | the
timing and progress of preclinical and clinical development activities; |
| ● | the
number and scope of preclinical and clinical programs that we decide to pursue; |
| ● | our
ability to maintain our current research and development programs and to establish new ones; |
| ● | establishing
an appropriate safety profile with investigational new drug-enabling studies; |
| ● | successful
patient enrollment in, and the initiation and completion of, clinical trials; |
| ● | the
successful completion of clinical trials with safety, tolerability and efficacy profiles
that are satisfactory to the FDA or any comparable foreign regulatory authority; |
| ● | the
receipt of regulatory approvals from applicable regulatory authorities; |
| ● | the
timing, receipt and terms of any marketing approvals from applicable regulatory authorities; |
| ● | our
ability to establish new licensing or collaboration arrangements; |
| ● | establishing
agreements with third-party manufacturers for clinical supply for our clinical trials and
commercial manufacturing, if any of our product candidates is approved; |
| ● | development
and timely delivery of clinical-grade and commercial-grade drug formulations that can be
used in our clinical trials and for commercial launch; |
| ● | obtaining,
maintaining, defending and enforcing patent claims and other intellectual property rights; |
| ● | launching
commercial sales of product candidates, if approved, whether alone or in collaboration with
others; |
| ● | maintaining
a continued acceptable safety profile of the product candidates following approval; and |
| ● | the
potential impact of COVID-19 or the widespread outbreak of any other communicable disease
on operations which may affect among other things, the timing of clinical trials, availability
of raw materials, and the ability to access and secure testing facilities. |
A
change in the outcome of any of these variables with respect to the development of our product candidates could significantly change
the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval
for any of our product candidates.
General
and Administrative Expenses
General
and administrative expenses consist primarily of salaries and related costs for personnel, including share-based compensation, in executive,
finance and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as
well as professional fees for legal, patent, consulting, accounting, and audit services.
Our
general and administrative expenses will increase in the future as we increase our headcount to support continued research activities
and development of product candidates. We will continue to incur increased accounting, audit, legal, regulatory, compliance and director
and officer insurance costs as well as investor and public relations expenses associated with being a public company.
Foreign
Exchange Gain
Foreign
exchange gain consists of net exchange rate changes on transactions denominated in currencies other than the U.S. dollar.
Results
of Operations
Comparison
of the Three Months Ended December 31, 2023 and 2022
The
following table summarizes our results of operations for the three months ended December 31, 2023 and 2022:
| |
Three
Months Ended December 31, | | |
| |
| |
2023 | | |
2022 | | |
Change | |
Collaboration
revenue | |
$ | 18,626 | | |
$ | 37,255 | | |
$ | (18,629 | ) |
Operating expenses: | |
| | | |
| | | |
| | |
Research and development | |
| 644,042 | | |
| 3,745,940 | | |
| (3,101,898 | ) |
General
and administrative | |
| 653,455 | | |
| 1,903,709 | | |
| (1,250,254 | ) |
Total
operating expenses | |
| 1,297,497 | | |
| 5,649,649 | | |
| (4,352,152 | ) |
Loss from operations | |
| (1,278,871 | ) | |
| (5,612,394 | ) | |
| 4,333,523 | |
Foreign exchange gain | |
| 110,362 | | |
| 70,252 | | |
| 40,110 | |
Net
loss | |
$ | (1,168,509 | ) | |
$ | (5,542,142 | ) | |
$ | 4,373,633 | |
Collaboration
Revenue
We
recognized $18,626 of revenue related to the New Life Agreement during the three months ended December 31, 2023 compared to $37,255 during
the three months ended December 31, 2022. The decrease of $18,629 was due to a delay in timing in the performance of R&D services.
Research
and Development Expenses
Research
and development expenses were $0.6 million for the three months ended December 31, 2023, compared to $3.7 million for the three months
ended December 31, 2022. The decrease of $3.1 million was primarily due to the cancellation of accrued but unpaid bonuses that had been
awarded for fiscal years 2022 and 2023 in the amount of $1.0 million, as well as due to cost saving initiatives, as we are managing expenses
for liquidity purposes and are tightening our focus on the research and development projects we have assessed to have the greatest near-term
potential. In addition to transitioning product development activities to cost advantaged locations such as India and Australia, we have
reduced expenditures on tertiary programs and suspended antiviral development related to SON-1010.
General
and Administrative Expenses
General
and administrative expenses were $0.7 million for the three months ended December 31, 2023, compared to $1.9 million for the three months
ended December 31, 2022. The decrease of $1.3 million relates primarily to the cancellation
of accrued but unpaid bonuses that had been awarded for fiscal years 2022 and 2023 in the amount of $0.9 million, and due to cost saving
initiatives, as we are managing expenses for liquidity purposes.
Liquidity
and Capital Resources
We
have funded operations to date primarily with proceeds from sales of common stock, warrants and proceeds from the issuance of convertible
debt. We will likely offer additional securities for sale in response to market conditions or other circumstances if we believe such
a plan of financing is required to advance our business plans and is in the best interests of our stockholders. There is no certainty
that equity or debt financing will be available in the future or that it will be at acceptable terms and at this time, it is not possible
to predict the outcome of these matters.
We
have incurred net losses of $1.2 million and $5.5 million for the three months ended December 31, 2023 and 2022, respectively. We expect
to continue to incur significant operational expenses and net losses in the upcoming 12 months and beyond. Our net losses may fluctuate
significantly from quarter to quarter and year to year, depending on the stage and complexity of our R&D studies and related expenditures,
the receipt of additional payments on the licensing of our technology, if any, and the receipt of payments under any current or future
collaborations we may enter into.
We
have evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to
continue as a going concern. We believe our cash of $3.0 million at December 31, 2023 will fund our projected operations into March
2024. We also recently executed an agreement to sell $4.8 million of our New Jersey state net operating losses through the Technology
Business Tax Certificate Transfer Program for expected net proceeds of $4.3 million, subject to final approval by the state. Substantial
additional financing will be needed by us to fund our operations. These factors raise substantial doubt about our ability to continue
as a going concern.
The
following table summarizes our sources and uses of cash for each of the periods presented:
| |
Three
Months Ended December 31, | |
| |
2023 | | |
2022 | |
Net cash used in operating activities | |
$ | (3,091,737 | ) | |
$ | (5,915,170 | ) |
Net cash provided by
financing activities | |
| 3,838,870 | | |
| 4,562,895 | |
Net increase (decrease)
in cash | |
$ | 747,133 | | |
$ | (1,352,275 | ) |
Operating
Activities
During
the three months ended December 31, 2023, we used $3.1
million of cash in operating activities which was primarily attributable to our net loss of $1.2 million; a $2.7 million net decrease
in accounts payable and accrued expenses and other current liabilities primarily due to the cancellation of accrued but unpaid bonuses
that had been awarded for fiscal years 2022 and 2023 and the decrease in research and development expenses; offset by a $0.9 million
net decrease in prepaid expenses and other current assets and incentive tax receivable, primarily related to the collection of the incentive
tax receivable for fiscal year 2023.
During
the three months ended December 31, 2022, we used $5.9
million of cash in operating activities which was primarily attributable to our net loss of $5.5 million and a net $0.5 million decrease
in incentive tax receivable, prepaid expenses and other current assets, accounts payable and accrued expenses and other current liabilities,
primarily related to research and development efforts. This amount was offset by $0.1 million of share-based compensation expense and
$0.1 million of acquired in-process research and development.
Financing
Activities
During
the three months ended December 31, 2023, net cash provided by financing activities was $3.8 million, consisting of net proceeds from
the sale of common stock and pre-funded warrants in a public offering.
During
the three months ended December 31, 2022, net cash provided by financing activities was $4.6 million, consisting of net proceeds from
the sale of common stock under an at-the-market facility.
Funding
Requirements
We
expect to continue to incur significant expenses in connection with our ongoing activities, particularly as we advance preclinical activities
and clinical trials of product candidates in development. In addition, we expect to continue to incur costs associated with operating
as a public company. The timing and amount of our operating expenditures will depend largely on:
| ● | the
scope, number, initiation, progress, timing, costs, design, duration, any potential delays,
and results of clinical trials and nonclinical studies for our current or future product
candidates; |
| ● | the
clinical development plans we establish for these product candidates; |
| ● | the
number and characteristics of product candidates and programs that we develop or may in-license; |
| ● | the
outcome, timing and cost of regulatory reviews, approvals or other actions to meet regulatory
requirements established by the FDA and comparable foreign regulatory authorities, including
the potential for the FDA or comparable foreign regulatory authorities to require that we
perform more studies for our product candidates than those that we currently expect; |
| ● | our
ability to obtain marketing approval for product candidates; |
| ● | the
cost of filing, prosecuting, defending and enforcing patent claims and other intellectual
property rights covering our product candidates; |
| ● | our
ability to maintain, expand and defend the scope of our intellectual property portfolio,
including the cost of defending intellectual property disputes, including patent infringement
actions brought by third parties against us or our product candidates; |
| ● | the
cost and timing of completion of commercial-scale outsourced manufacturing activities with
respect to product candidates; |
| ● | our
ability to establish and maintain licensing, collaboration or similar arrangements on favorable
terms and whether and to what extent we retain development or commercialization responsibilities
under any new licensing, collaboration or similar arrangement; |
| ● | the
cost of establishing sales, marketing and distribution capabilities for any product candidates
for which we may receive regulatory approval in regions where we choose to commercialize
our products on our own; |
| ● | the
success of any other business, product or technology that we acquire or in which we invest; |
| ● | the
costs of acquiring, licensing or investing in businesses, product candidates and technologies; |
| ● | our
need and ability to hire additional management and scientific and medical personnel; |
| ● | the
costs to operate as a public company in the United States, including the need to implement
additional financial and reporting systems and other internal systems and infrastructure
for our business; |
| ● | market
acceptance of our product candidates, to the extent any are approved for commercial sale; |
| ● | the
effect of competing technological and market developments; and |
| ● | the
potential impact of the COVID-19 pandemic or the widespread outbreak of any other communicable
disease on our clinical trials and operations. |
Until
such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity
offerings, debt financings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements with third parties.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, our ownership interest may
be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect the rights
of our stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants
that limit our ability to take specified actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties,
we may have to relinquish valuable rights to technologies, future revenue streams, research programs or product candidates or grant licenses
on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements
when needed, we may be required to delay, reduce or eliminate product development or future commercialization efforts, sell off assets,
or grant rights to develop and market product candidates that we would otherwise prefer to develop and market.
October
2023 Offering
On
October 26, 2023, we closed a public offering of common stock and certain warrants through Chardan Capital Markets, LLC and Ladenburg
Thalmann & Co. Inc. as underwriters, for net proceeds of $3.9 million through the issuance and sale of 1,306,250 shares of our common
stock and, to certain investors, pre-funded warrants to purchase 1,537,500 shares of common stock, and accompanying common warrants to
purchase up to an aggregate of 5,687,500 shares of our common stock. Each share of common stock and pre-funded warrant to purchase one
share of common stock was sold together with a common warrant to purchase two shares of common stock. The public offering price of each
share of common stock and accompanying common warrant was $1.60 and the public offering price of each pre-funded warrant and accompanying
common warrant was $1.5999. The common warrants are immediately exercisable at a price of $1.60 per share of common stock, expire five
years from the date of issuance and contain an alternative cashless exercise provision. The pre-funded warrants are immediately exercisable
at any time, until exercised in full, at a price of $0.0001 per share of common stock. In addition, warrants to purchase 85,312 shares
of common stock were issued to the underwriters as compensation for their services related to the offering. These common stock warrants
have an exercise price of $2.00 per share and expire five years from the date of issuance.
Contractual
Obligations and Commitments
The
following table summarizes our contractual obligations as of December 31, 2023 and the effects that such obligations are expected
to have on our liquidity and cash flows in future periods:
| |
Less
than 1 Year | | |
1
to 3 Years | | |
4
to 5 Years | | |
More
than 5 Years | | |
Total | |
Operating
Lease (1) | |
$ | 94,078 | | |
$ | 120,067 | | |
$ | — | | |
$ | — | | |
$ | 214,145 | |
Total | |
$ | 94,078 | | |
$ | 120,067 | | |
$ | — | | |
$ | — | | |
$ | 214,145 | |
(1)
Reflects obligations pursuant to our office lease in Princeton, New Jersey.
In
addition to the contracts with payment commitments that we have reflected in the table above, we have entered into other contracts in
the normal course of business with certain CROs, CMOs and other third-parties for preclinical research studies and testing, clinical
trials and manufacturing services. These contracts do not contain any minimum purchase commitments and are cancellable upon prior notice
and as a result, are not included in the table of contractual obligations and commitments above. Payments due upon cancellation consist
only of payments for services provided and expenses incurred, including non-cancellable obligations to our service providers, up to the
date of cancellation.
Critical
Accounting Policies and Estimates
Our
management’s discussion and analysis of financial condition and results of operations are based on our consolidated financial statements,
which have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make
estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets
and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to
the accrual for research and development expenses. We base our estimates on historical experience, known trends and events, and various
other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.
While
our significant accounting policies are described in more detail in the notes to the unaudited interim consolidated financial statements
included elsewhere in this Form 10-Q, we believe that the following accounting policies are those most critical to the judgments and
estimates used in the preparation of the consolidated financial statements.
Research
and Development Expenses
Research
and development expenses include all direct and indirect costs associated with the development of our biopharmaceutical products. These
expenses include personnel costs, consulting fees, and payments to third parties for research, development and manufacturing services.
These costs are charged to expense as incurred.
At
the end of each reporting period, we compare payments made to third-party service providers to the estimated progress toward completion
of the related project, based on the measure of progress as defined in the contract. Factors we consider in preparing the estimates include
costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of our service providers. Such
estimates are subject to change as additional information becomes available. Depending on the timing of payment to the third-party service
providers and the progress we estimate has been made as a result of the service provided, we will record a prepaid expense or accrued
liability related to these costs. Contingent development or regulatory milestone payments are recognized upon the related resolution
of such contingencies. As of December 31, 2023, we did not make any material adjustments to our prior estimates of accrued research
and development expenses.
Recently
Issued Accounting Pronouncements
A
description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations
is disclosed in Note 2 to the unaudited interim consolidated financial statements included elsewhere in this Form 10-Q.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Not
applicable.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
We
evaluated, under the supervision and with the participation of the principal executive officer and principal financial officer, the effectiveness
of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
and Exchange Act of 1934, as amended (“Exchange Act”)) as of December 31, 2023, the end of the period covered by this report
on Form 10-Q. Based on this evaluation, our Chairman, President and Chief Executive Officer (principal executive officer) and our Chief
Financial Officer (principal financial officer) have concluded that our disclosure controls and procedures were effective at the reasonable
assurance level at December 31, 2023.
Disclosure
controls and procedures are designed to provide reasonable assurance that information required to be disclosed by us in the reports that
we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the
SEC’s rules and forms, and (ii) is accumulated and communicated to management, including the principal executive officer and principal
financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure
controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving the desired control objectives. Due to the inherent limitations of control systems, not all misstatements
may be detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns
can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by
collusion of two or more people, or by management override of the control. Controls and procedures can only provide reasonable, not absolute,
assurance that the above objectives have been met.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting during the three months ended December
31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings.
We
are subject to various legal proceedings from time to time in the ordinary course of business, which may not be required to be disclosed
under this Item 1. For the three-month period ending December 31, 2023 covered by this Quarterly
Report, there have been no reportable legal proceedings or material developments to previously reported legal proceedings.
Item
1A. Risk Factors.
As
a smaller reporting company, we are not required to provide the information required by this item. However, we direct you to the risk
factors included in the Risk Factors section in our Annual Report on Form 10-K for the year ended September 30, 2023 filed with the Securities
and Exchange Commission on December 14, 2023.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item
3. Defaults Upon Senior Securities.
None
noted.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
None.
Item
6: Exhibits.
*
XBRL (Extensible Business Reporting Language) information is furnished and not filed or a part of a registration statement or prospectus
for purposes of Sections 11 or 12 of the Securities Act, is deemed not filed for purposes of Section 18 of the Exchange Act, and otherwise
is not subject to liability under these sections.
**
Furnished, not filed.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
SONNET
BIOTHERAPEUTICS HOLDINGS, INC. |
|
|
|
Date:
February 14, 2024 |
By: |
/s/
Pankaj Mohan |
|
|
Pankaj
Mohan |
|
|
President
and Chief Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
|
By: |
/s/
Jay Cross |
|
|
Jay
Cross |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial Officer and Principal Accounting Officer) |
Exhibit
31.1
Certification
of the Chief Executive Officer
Pursuant
to 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 302 OF
THE
SARBANES-OXLEY ACT OF 2002
I,
Pankaj Mohan, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q for the period ended December 31, 2023 of Sonnet BioTherapeutics Holdings, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
|
/s/
Pankaj Mohan |
|
Pankaj
Mohan |
Date:
February 14, 2024 |
Chief
Executive Officer |
|
(Principal
Executive Officer) |
Exhibit
31.2
Certification
of the Chief Financial Officer
Pursuant
to 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 302 OF
THE
SARBANES-OXLEY ACT OF 2002
I,
Jay Cross, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q for the period ended December 31, 2023 of Sonnet BioTherapeutics Holdings, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
|
/s/
Jay Cross |
|
Jay
Cross |
Date:
February 14, 2024 |
Chief
Financial Officer |
|
(Principal
Financial Officer) |
Exhibit
32.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER
PURSUANT
TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF
THE
SARBANES-OXLEY ACT OF 2002
I,
Pankaj Mohan, certify that:
1. |
I
am the Chief Executive Officer of Sonnet BioTherapeutics Holdings, Inc. (the “Issuer”). |
|
|
2. |
Attached
to this certification is the Quarterly Report on Form 10-Q for the quarter ended December 31, 2023 (the “Report”) filed
by the Issuer with the Securities Exchange Commission pursuant to Section 13(a) or 15(d) of the Securities and Exchange Act of 1934,
as amended (the “Exchange Act”), which contains financial statements. |
|
|
3. |
I
hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to
my knowledge: |
|
● |
The
Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and |
|
|
|
|
● |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Issuer. |
February
14, 2024 |
/s/
Pankaj Mohan |
|
Pankaj
Mohan |
|
Chief
Executive Officer |
|
(Principal
Executive Officer) |
Exhibit
32.2
CERTIFICATION
OF CHIEF FINANCIAL OFFICER
PURSUANT
TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF
THE
SARBANES-OXLEY ACT OF 2002
I,
Jay Cross, certify that:
1. |
I
am the Chief Financial Officer of Sonnet BioTherapeutics Holdings, Inc. (the “Issuer”). |
|
|
2. |
Attached
to this certification is the Quarterly Report on Form 10-Q for the quarter year ended December 31, 2023 (the “Report”)
filed by the Issuer with the Securities Exchange Commission pursuant to Section 13(a) or 15(d) of the Securities and Exchange Act
of 1934, as amended (the “Exchange Act”), which contains financial statements. |
|
|
3. |
I
hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to
my knowledge: |
|
● |
The
Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and |
|
|
|
|
● |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Issuer. |
February
14, 2024 |
/s/
Jay Cross |
|
Jay
Cross |
|
Chief
Financial Officer |
|
(Principal
Financial Officer) |
v3.24.0.1
Cover - shares
|
3 Months Ended |
|
Dec. 31, 2023 |
Feb. 07, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Dec. 31, 2023
|
|
Document Fiscal Period Focus |
Q1
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--09-30
|
|
Entity File Number |
001-35570
|
|
Entity Registrant Name |
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
|
|
Entity Central Index Key |
0001106838
|
|
Entity Tax Identification Number |
20-2932652
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
100
Overlook Center
|
|
Entity Address, Address Line Two |
Suite 102
|
|
Entity Address, City or Town |
Princeton
|
|
Entity Address, State or Province |
NJ
|
|
Entity Address, Postal Zip Code |
08540
|
|
City Area Code |
(609)
|
|
Local Phone Number |
375-2227
|
|
Title of 12(b) Security |
Common
Stock, par value $0.0001 per share
|
|
Trading Symbol |
SONN
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
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v3.24.0.1
Consolidated Balance Sheets (Unaudited) - USD ($)
|
Dec. 31, 2023 |
Sep. 30, 2023 |
Current assets: |
|
|
Cash |
$ 3,021,392
|
$ 2,274,259
|
Prepaid expenses and other current assets |
1,408,280
|
1,677,396
|
Incentive tax receivable |
194,111
|
786,574
|
Total current assets |
4,623,783
|
4,738,229
|
Property and equipment, net |
30,155
|
33,366
|
Operating lease right-of-use asset |
176,926
|
193,689
|
Deferred offering costs |
15,000
|
49,988
|
Other assets |
491,862
|
414,206
|
Total assets |
5,337,726
|
5,429,478
|
Current liabilities: |
|
|
Accounts payable |
1,655,390
|
2,201,999
|
Accrued expenses and other current liabilities |
923,191
|
3,230,922
|
Current portion of operating lease liability |
75,730
|
73,048
|
Deferred income |
|
18,626
|
Total current liabilities |
2,654,311
|
5,524,595
|
Operating lease liability, net of current portion |
110,956
|
130,863
|
Total liabilities |
2,765,267
|
5,655,458
|
Commitments and contingencies (Note 4) |
|
|
Stockholders’ equity (deficit): |
|
|
Common stock, $0.0001 par value: 125,000,000 shares authorized; 3,069,516 and 1,750,426 issued and outstanding at December 31, 2023 and September 30, 2023, respectively |
307
|
175
|
Additional paid-in capital |
113,984,414
|
110,017,598
|
Accumulated deficit |
(111,412,262)
|
(110,243,753)
|
Total stockholders’ equity (deficit) |
2,572,459
|
(225,980)
|
Total liabilities and stockholders’ equity (deficit) |
$ 5,337,726
|
$ 5,429,478
|
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v3.24.0.1
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Dec. 31, 2023 |
Sep. 30, 2023 |
Statement of Financial Position [Abstract] |
|
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
125,000,000
|
125,000,000
|
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3,069,516
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v3.24.0.1
Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
Dec. 31, 2023 |
Dec. 31, 2022 |
Income Statement [Abstract] |
|
|
Collaboration revenue |
$ 18,626
|
$ 37,255
|
Operating expenses: |
|
|
Research and development |
644,042
|
3,745,940
|
General and administrative |
653,455
|
1,903,709
|
Total operating expenses |
1,297,497
|
5,649,649
|
Loss from operations |
(1,278,871)
|
(5,612,394)
|
Foreign exchange gain |
110,362
|
70,252
|
Net loss |
$ (1,168,509)
|
$ (5,542,142)
|
Per share information: |
|
|
Net loss per share, basic |
$ (0.31)
|
$ (17.62)
|
Net loss per share, diluted |
$ (0.31)
|
$ (17.62)
|
Weighted average shares outstanding, basic |
3,797,753
|
314,472
|
Weighted average shares outstanding, diluted |
3,797,753
|
314,472
|
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v3.24.0.1
Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Sep. 30, 2022 |
$ 25
|
$ 88,872,315
|
$ (91,411,059)
|
$ (2,538,719)
|
Balance, shares at Sep. 30, 2022 |
251,973
|
|
|
|
Sale of common stock, net of issuance costs |
$ 11
|
4,452,001
|
|
4,452,012
|
Sale of common stock, net of issuance costs, shares |
109,841
|
|
|
|
Net share settlement of warrants |
|
|
|
|
Net share settlement of warrants, shares |
137
|
|
|
|
Share-based compensation |
|
91,617
|
|
91,617
|
Net loss |
|
|
(5,542,142)
|
(5,542,142)
|
Balance at Dec. 31, 2022 |
$ 36
|
93,415,933
|
(96,953,201)
|
(3,537,232)
|
Balance, shares at Dec. 31, 2022 |
361,951
|
|
|
|
Balance at Sep. 30, 2023 |
$ 175
|
110,017,598
|
(110,243,753)
|
(225,980)
|
Balance, shares at Sep. 30, 2023 |
1,750,426
|
|
|
|
Sale of common stock, net of issuance costs |
$ 131
|
3,916,812
|
|
3,916,943
|
Sale of common stock, net of issuance costs, shares |
1,306,250
|
|
|
|
Retirement of shares in connection with reverse stock split |
|
|
|
|
Retirement of shares in connection with reverse stock split, shares |
(1,522)
|
|
|
|
Net share settlement of warrants |
$ 1
|
(1)
|
|
|
Net share settlement of warrants, shares |
14,362
|
|
|
|
Share-based compensation |
|
50,005
|
|
50,005
|
Net loss |
|
|
(1,168,509)
|
(1,168,509)
|
Balance at Dec. 31, 2023 |
$ 307
|
$ 113,984,414
|
$ (111,412,262)
|
$ 2,572,459
|
Balance, shares at Dec. 31, 2023 |
3,069,516
|
|
|
|
X |
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v3.24.0.1
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
Dec. 31, 2023 |
Dec. 31, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (1,168,509)
|
$ (5,542,142)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Acquired in-process research and development |
12,000
|
100,000
|
Depreciation |
3,211
|
3,211
|
Amortization of operating lease right-of-use asset |
16,763
|
15,223
|
Share-based compensation |
50,005
|
91,617
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other current assets |
269,116
|
82,673
|
Incentive tax receivable |
592,463
|
(619,118)
|
Other assets |
(77,656)
|
|
Accounts payable |
(465,735)
|
(375,540)
|
Accrued expenses and other current liabilities |
(2,287,544)
|
383,362
|
Operating lease liability |
(17,225)
|
(17,201)
|
Deferred income |
(18,626)
|
(37,255)
|
Net cash used in operating activities |
(3,091,737)
|
(5,915,170)
|
Cash flows from financing activities: |
|
|
Proceeds from sale of common stock, net of issuance costs |
3,838,870
|
4,562,895
|
Net cash provided by financing activities |
3,838,870
|
4,562,895
|
Net increase (decrease) in cash |
747,133
|
(1,352,275)
|
Cash, beginning of period |
2,274,259
|
3,052,879
|
Cash, end of period |
3,021,392
|
1,700,604
|
Supplemental disclosure of non-cash operating, investing and financing activities: |
|
|
In-process research and development in accrued expenses |
12,000
|
261,250
|
Offering costs in accounts payable and accrued expenses |
15,000
|
138,878
|
Deferred offering costs charged against proceeds from sale of common stock |
|
$ 32,340
|
X |
- DefinitionThe amount of purchased research and development assets that are acquired in a business combination have no alternative future use and are therefore written off in the period of acquisition.
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v3.24.0.1
Organization and Description of Business
|
3 Months Ended |
Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Description of Business |
1.
Organization and Description of Business
Description
of business
Sonnet
BioTherapeutics, Inc. (“Prior Sonnet”) was incorporated as a New Jersey corporation on April 6, 2015. Prior Sonnet
completed a merger with publicly-held Chanticleer Holdings, Inc. (“Chanticleer”) on April 1, 2020. After the merger,
Chanticleer changed its name to Sonnet BioTherapeutics Holdings, Inc. (“Sonnet” or the “Company”). Sonnet is
a clinical stage, oncology-focused biotechnology company with a proprietary platform for innovating biologic medicines with single or bifunctional action. Known as FHAB™ (Fully Human Albumin Binding), the technology utilizes a fully human
single chain antibody fragment (scFv) that binds to and “hitch-hikes” on human serum albumin (“HSA”) for
transport to target tissues.
Sonnet’s
lead proprietary asset, SON-1010, is a fully human single chain version of Interleukin 12 (“IL-12”), covalently linked
to the FHAB construct, for which Sonnet is pursuing clinical development in solid tumor indications, including ovarian
cancer, non-small cell lung cancer and head and neck cancer. In March 2022, the FDA cleared Sonnet’s Investigational New Drug
(“IND”) application for SON-1010. This allowed the Company to initiate a U.S. clinical trial (SB101) in oncology
patients with solid tumors during the second calendar quarter of 2022. In September 2021, the Company created a wholly-owned
Australian subsidiary, SonnetBio Pty Ltd (“Subsidiary”), for the purpose of conducting certain clinical trials in that country. Sonnet
received approval and initiated an Australian clinical study (SB102) of SON-1010 in healthy volunteers during the third calendar
quarter of 2022. Interim safety and tolerability data from the SB101 and SB102 studies were reported in April 2023.
In
January 2023, Sonnet announced a collaboration agreement with Roche for the clinical evaluation of SON-1010 with atezolizumab (Tecentriq®).
The companies have entered into a Master Clinical Trial and Supply Agreement (“MCSA”), along with ancillary Quality and Safety
Agreements, to study the safety and efficacy of the combination of SON-1010 and atezolizumab in a platinum-resistant ovarian cancer (“PROC”)
patient setting. Furthermore, the companies will provide SON-1010 and atezolizumab, respectively, for use in the Phase 1b/Phase 2a combination
safety, dose-escalation, and efficacy study (SB221). Part 1 of this 2-part study was approved in June 2023 by the local Human Research
Ethics Committee in Australia under CT-2023-CTN-01399-1 and the Therapeutic Goods Administration has been notified. In August 2023, the
FDA accepted the IND for SON-1010 in this indication. The trial consists of a modified 3+3 dose-escalation design in Part 1 to establish the maximum tolerated
dose (“MTD”) of SON-1010 with a fixed dose of atezolizumab. Clinical benefit in PROC will be confirmed in an expansion group
to establish the recommended Phase 2 dose (“RP2D”). Part 2 of the study will then investigate SON-1010 monotherapy, its use
in combination with atezolizumab, or the standard of care (“SOC”) for PROC in a randomized comparison to show proof-of-concept
(“POC”).
As
part of the ongoing cost-cutting evaluations, all antiviral development with SON-1010 has been suspended.
The
Company acquired the global development rights to its most advanced compound, SON-080, a fully human version of Interleukin 6 (“IL-6”),
in April 2020 through its acquisition of the outstanding shares of Relief Therapeutics SA. Sonnet is advancing SON-080 in target indications
of Chemotherapy-Induced Peripheral Neuropathy (“CIPN”) and Diabetic Peripheral Neuropathy (“DPN”). Sonnet received
approval to initiate an ex-U.S. Phase 1b/2a study with SON-080 in CIPN during the third quarter of 2022. The Data Safety Monitoring Board
(“DSMB”) overseeing the study is expected to meet during the first calendar quarter of 2024. Following the completion of
the DSMB review, Sonnet anticipates announcing initial safety data from the CIPN study. Pursuant to a license agreement the Company entered
into with New Life Therapeutics Pte, Ltd. (“New Life”) of Singapore in May 2021, Sonnet and New Life will be jointly responsible
for developing SON-080 in DPN. The objective will be to analyze the data and to consider initiating a Phase 2 study once the CIPN safety
data has been evaluated.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
SON-1210
(IL12-FHAB-IL15), Sonnet’s lead bifunctional construct, combines FHAB with fully human IL-12 and fully
human Interleukin 15 (“IL-15”). This compound is being developed for solid tumor indications, including colorectal
cancer. In February 2023, the Company announced the successful completion of two IND-enabling toxicology studies with SON-1210
in non-human primates. Sonnet is prepared to initiate the regulatory authorization process for SON-1210 to begin clinical
development pending the outcome of any partnering activity.
SON-1410
(IL18-FHAB-IL12)
is a bifunctional combination of Interleukin 18 (“IL-18”) and IL-12 for solid tumor cancers. Cell line development and process
development are ongoing, with early experimental drug supply suitable for formulation and analytical method development activities. After
some delays in 2023, activities will continue through 2024 with the potential to generate a drug suitable for preclinical studies and
subsequent human studies.
The
Company has completed sequence confirmation for SON-3015 (anti-IL6-FHAB-anti-TGFβ). Early stage bifunctional drug
has been generated and is being stored for future use with in vivo studies in mice. Sonnet has elected to place the SON-3015
development program on hold for expense reduction purposes.
Liquidity
The
Company has incurred recurring losses and negative cash flows from operations since inception and it expects to generate losses from
operations for the foreseeable future primarily due to research and development costs for its potential product candidates. The Company
believes its cash of $3.0 million at December 31, 2023 will fund the Company’s projected operations into March 2024. These
factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim
consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business. The unaudited interim consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
The
Company recently executed an agreement to sell $4.8 million of its New Jersey state net operating losses through the Technology Business
Tax Certificate Transfer Program (the “Program”) for expected net proceeds of $4.3 million, subject to final approval by
the state. Substantial additional financing will be needed by the Company to fund its operations. The Company plans to secure additional
capital in the future through equity or debt financings, partnerships, collaborations, or other sources to carry out the Company’s
planned development activities. If additional capital is not available when required, the Company may need to delay or curtail its operations
until such funding is received. Various internal and external factors will affect whether and when the Company’s product candidates
become approved for marketing and successful commercialization. The regulatory approval and market acceptance of the Company’s
product candidates, length of time and cost of developing and commercializing these product candidates and/or failure of them at any
stage of the approval process will materially affect the Company’s financial condition and future operations.
Operations
since inception have consisted primarily of organizing the Company, securing financing, developing technologies through research and
development and conducting preclinical and clinical studies. The Company faces risks associated with companies whose products are in
development. These risks include the need for additional financing to complete its research and development, achieving its research and
development objectives, defending its intellectual property rights, recruiting and retaining skilled personnel, and dependence on key
members of management.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
|
X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.24.0.1
Summary of Significant Accounting Policies
|
3 Months Ended |
Dec. 31, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2.
Summary of Significant Accounting Policies
a. Basis of presentation
The
accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information as found in the Accounting Standards Codification (“ASC”)
and Accounting Standards Updates (ASUs”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management,
the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily
of accruals, estimates and assumptions that impact the unaudited interim consolidated financial statements) considered necessary to present
fairly the Company’s financial position as of December 31, 2023 and its results of operations and cash flows for the three
months ended December 31, 2023 and 2022. The unaudited interim consolidated financial statements presented herein do not contain the
required disclosures under U.S. GAAP for annual financial statements and should be read in conjunction with the annual audited financial
statements and related notes of Sonnet as of and for the year ended September 30, 2023 included in the Company’s Annual Report
on Form 10-K for the fiscal year ended September 30, 2023. The results of operations for the interim periods are not necessarily indicative
of the results of operations to be expected for the full year.
b. Consolidation
The
unaudited interim consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany
accounts and transactions have been eliminated in consolidation.
c. Use of estimates
The
preparation of the unaudited interim consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Significant estimates
and assumptions reflected in these unaudited interim consolidated financial statements include the accrual of research and development
expenses. Estimates and assumptions are periodically reviewed in-light of changes in circumstances, facts and experience. Changes in
estimates are recorded in the period in which they become known. Actual results could differ from management’s estimates.
d. Incentive tax receivable
Subsidiary
is eligible to participate in an Australian research and development tax incentive program. As part of this program, Subsidiary is eligible
to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by Subsidiary
in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian)
during the reimbursable period. The Company estimates the amount of cash refund it expects to receive related to the Australian research
and development tax incentive program and records the incentive when it is probable (i) the Company will comply with relevant conditions
of the program and (ii) the incentive will be received. As of December 31, 2023, the Company’s estimate of the amount of cash
refund it expects to receive for eligible spending related to the Australian research and development tax incentive program was $0.2 million.
For the three months ended December 31, 2023 and 2022, $0.2 million and $0.3 million, respectively, for the expected cash refund related
to the tax incentive program was included as an offset to research and development expenses. In December 2023, the Company received $0.8
million from the Australian government related to eligible research and development expenses for the year ended September 30, 2023.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
e. Property and equipment
Property
and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Expenditures
for repairs and maintenance that do not extend the estimated useful life or improve an asset are expensed as incurred. Upon retirement
or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts, and any
resulting gain or loss is included in the consolidated statement of operations.
f. Collaboration revenue
Collaboration
arrangements may contain multiple components, which may include (i) licenses; (ii) research and development activities; and (iii) the
manufacturing and supply of certain materials. Payments pursuant to these arrangements may include non-refundable payments, upfront payments,
milestone payments upon the achievement of significant regulatory and development events, sales milestones and royalties on product sales.
The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in
a future period.
In
determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under a collaboration arrangement,
the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of
whether the promised goods or services are performance obligations, including whether they are capable of being distinct; (iii) measurement
of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance
obligations; and (v) recognition of revenue as the Company satisfies each performance obligation.
The
Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating
transaction price to performance obligations within a contract, determining when performance obligations have been met, and assessing
the recognition of variable consideration. When consideration is received prior to the Company completing its performance obligation
under the terms of a contract, a contract liability is recorded as deferred income. Deferred income expected to be recognized as revenue
within the twelve months following the balance sheet date is classified as a current liability. In May 2021, the Company entered into
a License Agreement (the “New Life Agreement”) with New Life. See Note 5 for
further discussion of the New Life Agreement.
g. Research and development expense
Research
and development expenses include all direct and indirect costs associated with the development of the Company’s biopharmaceutical
products. These expenses include personnel costs, consulting fees, and payments to third parties for research, development, and manufacturing
services. These costs are charged to expense as incurred.
At
the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward
completion of the related project, based on the measure of progress as defined in the contract. Factors the Company considers in preparing
the estimates include costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of its service
providers. Such estimates are subject to change as additional information becomes available. Depending on the timing of payment to the
service providers and the progress that the Company estimates has been made as a result of the service provided, the Company will record
a prepaid expense or accrued liability relating to these costs. Upfront milestone payments made to third parties who perform research
and development services on the Company’s behalf are expensed as services are rendered. Contingent development or regulatory milestone
payments are recognized upon the related resolution of such contingencies.
h. Reverse stock split
On
August 31, 2023, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary of
State of the State of Delaware, which effected a 1-for-22 reverse stock split of the Company’s issued and outstanding shares of
common stock. As a result of the reverse stock split, every 22 shares of common stock issued and outstanding was converted into one share
of common stock. The reverse stock split affected all stockholders uniformly and did not alter any stockholder’s percentage interest
in the Company’s equity. No fractional shares were issued in connection with the reverse stock split. Stockholders who would otherwise
be entitled to a fractional share of common stock were instead entitled to receive a proportional cash payment. The reverse stock split
did not change the par value or authorized number of shares of common stock. All common share and per share amounts presented in the
unaudited interim consolidated financial statements and accompanying notes have been retroactively adjusted to reflect the reverse stock
split.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
i. Net loss per share
Basic
net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each
period (and potential shares of common stock that are exercisable for little or no consideration). Included in basic weighted-average
number of shares of common stock outstanding during the three months ended December 31, 2023 are the pre-funded October 2023 warrants
to purchase 1,537,500 shares of common stock with an exercise price of $0.0001 per share. Included in basic weighted-average number of
shares of common stock outstanding during the three months ended December 31, 2022 are the Series B warrants to purchase 137 shares
of common stock with an exercise price of $0.0308 per share, which were net share settled in November 2022.
Diluted
loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and
stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average
number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities
are not included in the calculation as the impact is anti-dilutive.
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule of Potentially Dilutive Securities
| |
2023 | | |
2022 | |
| |
December
31, | |
| |
2023 | | |
2022 | |
Common stock warrants August 2021 | |
| 112,429 | | |
| 128,500 | |
Underwriter warrants August 2021 | |
| 2,287 | | |
| 2,287 | |
Private warrants | |
| — | | |
| 90 | |
Chanticleer warrants | |
| 57 | | |
| 57 | |
Series C warrants | |
| 18,391 | | |
| 36,778 | |
Series 3 warrants | |
| 12,548 | | |
| 12,548 | |
Unvested restricted stock units and awards | |
| 7,840 | | |
| 10,002 | |
Common stock warrants February 2023 | |
| 271,883 | | |
| — | |
Underwriter warrants February 2023 | |
| 15,466 | | |
| — | |
Common stock private placement warrants June
2023 | |
| 227,272 | | |
| — | |
Placement agent warrants June 2023 | |
| 6,818 | | |
| — | |
Common stock warrants October 2023 | |
| 5,687,500 | | |
| — | |
Underwriter warrants October 2023 | |
| 85,312 | | |
| — | |
Total anti-dilutive weighted
average shares | |
| 6,447,803 | | |
| 190,262 | |
j. Recent accounting pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU
2023-07, which is applicable to entities with a single reportable segment, will primarily require enhanced disclosures about significant
segment expenses and enhanced disclosures in interim periods. The guidance in ASU 2023-07 will be applied retrospectively and is effective
for annual reporting periods in fiscal years beginning after December 15, 2023 and interim reporting periods in fiscal years beginning
after December 31, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-07
will have on its consolidated financial statements and disclosures.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 is intended
to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the
rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the
income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning
after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated
financial statements and disclosures.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.24.0.1
Accrued Expenses and Other Current Liabilities
|
3 Months Ended |
Dec. 31, 2023 |
Payables and Accruals [Abstract] |
|
Accrued Expenses and Other Current Liabilities |
3.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following:
Schedule of Accrued Expenses and Other Current Liabilities
| |
December 31, | | |
September
30, | |
| |
2023 | | |
2023 | |
Compensation and benefits | |
$ | 141,636 | | |
$ | 2,091,196 | |
Research and development | |
| 564,674 | | |
| 913,145 | |
Professional fees | |
| 213,912 | | |
| 224,031 | |
Other | |
| 2,969 | | |
| 2,550 | |
Accrued expenses and
other current liabilities | |
$ | 923,191 | | |
$ | 3,230,922 | |
During
the current period, the Company cancelled accrued but unpaid bonuses that had been awarded for fiscal years 2022 and 2023, which has
been accounted for as a change in estimate. The cancellation of bonuses reduced research and development expenses by $1.0 million and
general and administrative expenses by $0.9 million for the three months ended December 31, 2023.
|
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- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
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v3.24.0.1
Commitments and Contingencies
|
3 Months Ended |
Dec. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
4.
Commitments and Contingencies
Legal
proceedings
From
time to time, the Company is a party to various lawsuits, claims, and other legal proceedings that arise in the ordinary course of its
business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters
will have a material adverse effect on the Company’s consolidated financial position, results of operations, or cash flows.
License
agreements
In
July 2012, the Company entered into a Discovery Collaboration Agreement (the “Collaboration Agreement”) with XOMA (US) LLC
(“XOMA”), pursuant to which XOMA granted to the Company a non-exclusive, non-transferable license and/or right to use certain
materials, technologies and related information for the discovery, optimization and development of antibodies and related proteins
and to develop and commercialize products thereunder. The Company is obligated to make contingent milestone payments to XOMA totaling
$3.8 million on a product-by-product basis upon the achievement of certain development and approval milestones related to a product.
The Company has also agreed to pay XOMA low single-digit royalties on net sales of products sold by the Company. Royalties on each product
are payable on a country-by-country basis until the later of (i) a specified period of time after the first commercial sale, and (ii)
the date of expiration of the last valid claim in the last-to-expire of the issued patents covered by the Collaboration Agreement. The
first milestone was achieved in April 2022, at which time the Company incurred a $0.5 million license fee which was recorded as acquired
in-process research and development. No license fees were incurred during the three months ended December 31, 2023 and 2022.
In
August 2015, the Company entered into a License Agreement (the “ARES License Agreement”) with Ares Trading, a wholly-owned
subsidiary of Merck KGaA (“ARES”). Under the terms of the ARES License Agreement, ARES has granted the Company a sublicensable,
exclusive, worldwide, royalty-bearing license on proprietary patents to research, develop, use and commercialize products using atexakin
alfa (“Atexakin”), a low dose formulation of human IL-6 in peripheral neuropathies and vascular complications. Pursuant to
the ARES License Agreement, the Company will pay ARES mid single-digit royalties on net sales of products sold by the Company. Royalties
are payable on a product-by-product and country-by-country basis until the later of (i) a specified period of time after the first commercial
sale in such country, and (ii) the last date on which such product is covered by a valid claim in such country.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In
January 2019, the Company entered into a Frame Services and License Agreement (the “Cellca Agreement”) with Sartorius Stedim
Cellca GMBH (“Cellca”), pursuant to which Cellca has granted the Company a worldwide, non-exclusive, perpetual, non-transferable
license to develop, manufacture or have manufactured, use, sell, import, export and/or otherwise commercialize product based on Cellca’s
work to generate a specified transfected cell line and develop an upstream production process for such cell line. The Cellca Agreement
is effective unless terminated by either party by giving six months notice, or by giving 14 days notice if terminated for good cause.
The Company is obligated to make milestone payments to Cellca totaling up to $0.7 million upon the achievement of certain development
and approval milestones if the Buy-Out Option is not exercised. The Company has a Buy-Out Option that will be effective between the time
of completion of a clinical trial and the receipt of regulatory approval for commercialization of product. The cost to exercise the Buy-Out
Option increases on each anniversary of the commencement date of the Buy-Out Option Period, and ranges from $0.1 million to $0.6 million.
The cost to exercise the Buy-Out Option will replace the $0.6 million contingent milestone payment due upon final regulatory approval.
The first milestone was achieved in April 2022, at which time the Company incurred a $0.1 million license fees which was recorded as
acquired in-process research and development. No license fees were incurred during the three months ended December 31, 2023 and 2022.
In
October 2021, the Company entered into a Non-Exclusive License Agreement (the “Brink Agreement”) with Brink Biologics Inc.
(“Brink”), pursuant to which Brink has granted the Company a non-exclusive, non-transferable license and limited right to
sublicense certain materials and related information to develop cell-based assays for batch, quality control, stability, efficacy, potency
or any other type of assay required for production and commercialization of products. During the product development phase, the Company
was obligated to make annual product development license fee payments of approximately $0.1 million. In April 2023, the Brink Agreement
was amended, effective November 2022, to reduce the annual license fee payments to $12,000 for storage. If materials are removed from
storage during the product development phase, the annual product development license fee of approximately $0.1 million will apply. If
a product achieves commercial status, the Company is obligated to make a commercial product license fee payment of approximately $0.1
million per commercial product. The amended agreement has an initial term of one year and will automatically renew for one additional
year unless terminated or converted to a product development license. After the second year, the license will automatically convert to
a full license requiring a product development or a commercial product license fee unless the parties mutually agree to terminate the
agreement. The Company incurred $12,000 in license fees during the three months ended December 31, 2023, which were recorded as
acquired in-process research and development and included in research and development expenses in the unaudited interim consolidated
statement of operations. No license fees were incurred during the three months ended December 31, 2022.
In
February 2022, the Company entered into a Biological Materials License Agreement (the “InvivoGen Agreement”) with InvivoGen
SAS (“InvivoGen”), pursuant to which InvivoGen has granted the Company a worldwide, non-exclusive license to use certain
reporter cells for research, development and/or quality control purposes. The InvivoGen Agreement has an initial term of three years
and may be extended for two additional three-year periods upon written notice by the Company and payment of an approximately €0.1
million fee per extension (approximately $0.1 million as of December 31, 2023). No license fees were incurred during the three months
ended December 31, 2023 and 2022.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In
March 2022, the Company entered into a Material Transfer and License Agreement (the “ProteoNic Agreement”) with
ProteoNic B.V. (“ProteoNic”), pursuant to which ProteoNic has granted to the Company a non-exclusive, non-transferable,
non-sublicensable (except as provided for in the ProteoNic Agreement) license for certain materials, including plasmids and DNA
sequences used to generate the vectors used in the Company’s cell lines, for the Company’s use in research, development
and commercialization of product. The license will continue until terminated by either party. The Company incurred a $24,600
license fee upon obtaining the license. The Company was obligated to make contingent milestone payments to ProteoNic totaling up to
€1.2
million (approximately $1.3
million as of December 31, 2023) upon the achievement of certain development and commercialization milestones as outlined in
the ProteoNic Agreement. No
license fees were incurred during the three months ended December 31, 2023 and 2022. In January 2024, the Company terminated the
ProteoNic Agreement and has no further obligations under the arrangement.
Research
and development agreement
In
December 2021, the Company entered into a Research and Development Agreement (the “Navigo Agreement”), as subsequently amended,
with Navigo Proteins GmbH (“Navigo”), pursuant to which Navigo will perform specified evaluation and development procedures
to evaluate certain materials to determine their commercial potential. Under the terms of the Navigo Agreement, the Company has granted
Navigo a royalty-free, non-exclusive, worldwide, non-sublicensable, non-transferable right and license to use certain technology to perform
the evaluation and development activities, and Navigo has granted the Company (i) an exclusive, worldwide, perpetual, irrevocable, sublicensable,
transferable, royalty-free right and license to research, develop, use, sell, have sold, distribute, import or otherwise commercially
exploit certain materials, and (ii) a non-exclusive, worldwide, perpetual, sublicensable, non-transferable right and license to make
or have made such materials. The Company incurred a $0.1 million technology access fee upon execution of the Navigo Agreement, at which
time it was recorded as acquired in-process research and development. The Company is obligated to make contingent milestone payments
to Navigo, totaling up to $1.0 million upon the achievement of certain evaluation and development milestones as outlined in the Navigo
Agreement. Certain evaluation milestones were achieved in 2023, including $0.1 million in license
fees which were recorded as acquired in-process research and development and included as research and development expenses in the unaudited
interim consolidated statement of operations for the three months ended December 31, 2022. No milestones were achieved and no license
fees were incurred during the three months ended December 31, 2023.
Employment
agreements
The
Company has entered into employment contracts with its officers and certain employees that provide for severance and continuation of
benefits in the event of termination of employment either by the Company without cause or by the employee for good reason, both as defined
in the contract. In addition, in the event of termination of employment following a change in control, as defined, either by the Company
without cause or by the employee for good reason, any unvested portion of the employee’s initial stock option grant becomes immediately
vested.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
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v3.24.0.1
Collaboration Revenue
|
3 Months Ended |
Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Collaboration Revenue |
5.
Collaboration Revenue
Under
the New Life Agreement, the Company granted New Life an exclusive license (with the right to sublicense) to develop and commercialize
pharmaceutical preparations containing a specific recombinant human IL-6, SON-080 (the “Compound”) (such preparations, the
“Products”) for the prevention, treatment or palliation of diabetic peripheral neuropathy in humans (the “DPN Field”)
in Malaysia, Singapore, Indonesia, Thailand, Philippines, Vietnam, Brunei, Myanmar, Lao PDR and Cambodia (the “Exclusive Territory”).
New Life had the option to expand (1) the field of the exclusive license to include the prevention, treatment or palliation of chemotherapy-induced
peripheral neuropathy in humans (the “CIPN Field”), which option was non-exclusive and expired on December 31, 2021; and/or
(2) the territorial scope of the license to include the People’s Republic of China, Hong Kong and/or India, which option was exclusive
and expired on December 31, 2021.
The
Company will retain all rights to manufacture Compounds and Products anywhere in the world. The Company and New Life shall enter into
a follow-on supply agreement pursuant to which the Company shall supply to New Life Products for development and commercialization thereof
in the DPN Field in the Exclusive Territory on terms to be negotiated by the parties. The Company will also assist in transferring certain
preclinical and clinical development know-how that is instrumental in New Life’s ability to benefit from the license.
New
Life will bear the cost of, and be responsible for, among other things, conducting clinical studies and additional non-clinical studies
and other developmental and regulatory activities for and commercializing Products in the DPN Field in the Exclusive Territory.
New
Life paid the Company a $0.5 million non-refundable upfront cash payment in August 2020 upon executing a letter of intent to negotiate
a license agreement and a $0.5 million non-refundable upfront cash payment in June 2021 in connection with the execution of the New Life
Agreement. New Life is also obligated to pay a non-refundable deferred license fee of an additional $1.0 million at the time of the satisfaction
of certain milestones, as well as potential additional milestone payments to the Company of up to $19.0 million subject to the achievement
of certain development and commercialization milestones. In addition, during the Royalty Term (as defined below), New Life is obligated
to pay the Company tiered double-digit royalties ranging from 12% to 30% based on annual net sales of Products in the Exclusive Territory.
The “Royalty Term” means, on a Product-by-Product and a country-by-country basis in the Exclusive Territory, the period commencing
on the date of the first commercial sale (subject to certain conditions) of such Product in such country in the Exclusive Territory and
continuing until New Life ceases commercialization of such Product in the DIPN Field.
The
New Life Agreement will remain in effect on a Product-by-Product, country-by-country basis and will expire upon the expiration of the
Royalty Term for the last-to-expire Product in the last-to-expire country, subject to (i) each party’s early termination rights
including for material breach or insolvency or bankruptcy of the other party and (ii) the Company’s Buy Back Right and New Life’s
Give Back Right (as defined below).
In
addition, New Life granted to the Company an exclusive option to buy back the rights granted by the Company to New Life and the Company
granted New Life the right to give back the rights with respect to Products in the DPN Field in one or more countries in the Exclusive
Territory on terms to be agreed upon, which options will expire upon the initiation of a Phase III Trial for the applicable Product.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Revenue
recognition
The
Company first assessed the New Life Agreement under ASC 808, Collaborative Arrangements (“ASC 808”), to determine
whether the New Life Agreement or units of accounts within the New Life Agreement represent a collaborative arrangement based on the
risks and rewards and activities of the parties. The Company applied relevant guidance from ASC 606, Revenue from Contracts with Customers
(“ASC 606”), to evaluate the appropriate accounting for the collaborative arrangement with New Life. In accordance with
this guidance, the Company identified the following obligations under the arrangement: (i) License to develop, market, import, use and
commercialize the Product in the Field in the Exclusive Territory (the “License”); and (ii) transfer of know-how and clinical
development and regulatory activities (“R&D Activities”). The options to expand the CIPN Field and territory as well
as the future supply agreement represent optional purchases, which are accounted for as separate contracts. The Company evaluated these
separate contracts and did not identify any material right to be present. The Company determined that License and the R&D services
are not distinct from each other and therefore combined these material promises into a single performance obligation.
The
Company determined the initial transaction price of the single performance obligation to be $1.0 million, as the future development and
commercialization milestones, which represent variable consideration, are subject to constraint at inception. At the end of each subsequent
reporting period, the Company will reevaluate the probability of achievement of the future development and commercialization milestones
subject to constraint and, if necessary, will adjust its estimate of the overall transaction price. Any such adjustments will be recorded
on a cumulative catch-up basis. For the sales-based royalties, the Company will recognize revenue when the related sales occur.
Collaboration
revenue from the single performance obligation is being recognized over the estimated performance of the R&D services. The Company
recognized $18,626 and $37,255 of collaboration revenue for the three months ended December 31, 2023 and 2022, respectively.
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v3.24.0.1
Stockholders’ Deficit
|
3 Months Ended |
Dec. 31, 2023 |
Equity [Abstract] |
|
Stockholders’ Deficit |
6.
Stockholders’ Deficit
On
October 26, 2023, the Company closed a public offering of common stock and certain warrants through Chardan Capital Markets, LLC and
Ladenburg Thalmann & Co. Inc. as underwriters, for net proceeds of $3.9 million through the issuance and sale of 1,306,250 shares
of its common stock and, to certain investors, pre-funded warrants to purchase 1,537,500 shares of common stock, and accompanying common
warrants to purchase up to an aggregate of 5,687,500 shares of its common stock. Each share of common stock and pre-funded warrant to
purchase one share of common stock was sold together with a common warrant to purchase two shares of common stock. The public offering
price of each share of common stock and accompanying common warrant was $1.60 and the public offering price of each pre-funded warrant
and accompanying common warrant was $1.5999. The common warrants are immediately exercisable at a price of $1.60 per share of common
stock, expire five years from the date of issuance and contain an alternative cashless exercise provision. The pre-funded warrants are
immediately exercisable at any time, until exercised in full, at a price of $0.0001 per share of common stock. In addition, warrants
to purchase 85,312 shares of common stock were issued to the underwriters as compensation for their services related to the offering.
These common stock warrants have an exercise price of $2.00 per share and expire five years from the date of issuance.
The
Company entered into an At-the-Market Sales Agreement with BTIG, LLC (“BTIG”) on August 15, 2022 (the “2022 Sales Agreement”).
Pursuant to the 2022 Sales Agreement, the Company could offer and sell, from time to time, through BTIG, as sales agent and/or principal,
shares of its common stock having an aggregate offering price of up to $25.0 million, subject to certain limitations on the amount of
common stock that may be offered and sold by the Company set forth in the 2022 Sales Agreement. Due to the offering limitations applicable
to the Company, the Company filed prospectus supplements for the sale of shares of its common stock for an aggregate offering price of
up to $7.8 million pursuant to the 2022 Sales Agreement. During the three months ended December 31, 2022, the Company sold 109,841
shares of common stock pursuant to the 2022 Sales Agreement for gross proceeds of $4.8 million and net proceeds of $4.5 million. There
are no registered shares remaining to be sold under the 2022 Sales Agreement.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Common
stock warrants
As
of December 31, 2023, the following equity-classified warrants and related terms were outstanding:
Schedule of Warrants Outstanding
| |
Warrants
Outstanding | | |
Exercise
Price | | |
Expiration
Date |
Common stock warrants August 2021 | |
| 112,429 | | |
$ | 261.80 | | |
August 24, 2026 |
Underwriter warrants August 2021 | |
| 2,287 | | |
$ | 327.25 | | |
August 19, 2026 |
Chanticleer warrants | |
| 57 | | |
$ | 18,018.00
- 28,028.00 | | |
April 30, 2027 - December 17, 2028 |
Series C warrants | |
| 18,391 | | |
$ | 982.52 | | |
October 16, 2025 |
Series 3 warrants | |
| 12,548 | | |
$ | 89.628 | | |
August 15, 2027 |
Common stock warrants February 2023 | |
| 271,883 | | |
$ | 23.76 | | |
February 10, 2028 |
Underwriter warrants February 2023 | |
| 15,466 | | |
$ | 29.70 | | |
February 8, 2028 |
Common stock private placement warrants June
2023 | |
| 227,272 | | |
$ | 14.8478 | | |
December 30, 2026 |
Placement agent warrants June 2023 | |
| 6,818 | | |
$ | 14.8478 | | |
December 30, 2026 |
Common stock warrants October 2023 | |
| 5,687,500 | | |
$ | 1.60 | | |
October 27, 2028 |
Pre-funded warrants October 2023 | |
| 1,537,500 | | |
$ | 0.0001 | | |
— |
Underwriter warrants October 2023 | |
| 85,312 | | |
$ | 2.00 | | |
October 24, 2028 |
Total | |
| 7,977,463 | | |
| | | |
|
During
the three months ended December 31, 2023, 28,724 of
warrants were net share settled, resulting in the issuance of 14,362 shares of common stock, and 34,458 of warrants were abandoned by
the warrant holder.
During
the three months ended December 31, 2022, 137 of warrants were net share settled, resulting in the issuance of 137 shares of common stock,
and 242 of warrants expired.
|
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- DefinitionThe entire disclosure for equity.
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v3.24.0.1
Share-Based Compensation
|
3 Months Ended |
Dec. 31, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Share-Based Compensation |
7.
Share-Based Compensation
In
April 2020, the Company adopted the 2020 Omnibus Equity Incentive Plan (the “Plan”). On
January 1, 2024, the total number of shares authorized under the Plan increased to 122,780. There were 14,480 shares available
for issuance under the Plan as of December 31, 2023. The Plan increases the amount of shares issuable under the Plan by four
percent of the outstanding shares of common stock at each January 1, each year. The Plan permits the granting of share-based awards,
including stock options, restricted stock units and awards, stock appreciation rights and other types of awards as deemed appropriate,
in each case, in accordance with the terms of the Plan. The terms of the awards are determined by the Company’s Board of Directors.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Restricted
stock units and awards
Any
unvested restricted stock units (“RSUs”) or restricted stock awards (“RSAs”) will be forfeited upon termination
of services. The fair value of an RSU or RSA is equal to the fair market value of the Company’s common stock on the date of grant.
RSU and RSA expense is amortized straight-line over the vesting period.
The
Company recorded share-based compensation expense associated with the RSUs and RSAs in its accompanying unaudited interim consolidated
statements of operations as follows:
Schedule of Share-based Compensation Expense
| |
2023 | | |
2022 | |
| |
Three
Months Ended December 31, | |
| |
2023 | | |
2022 | |
Research and development | |
$ | 24,554 | | |
$ | 46,708 | |
General and administrative | |
| 25,451 | | |
| 44,909 | |
Share Based Compensation | |
$ | 50,005 | | |
$ | 91,617 | |
The
following table summarizes RSU activity under the Plan:
Schedule of Restricted Stock Units Activity
| |
| | |
Weighted | |
| |
| | |
Average Grant | |
| |
RSU | | |
Date
Fair Value | |
Unvested balance at December
31, 2023 | |
| 2,326 | | |
$ | 21.78 | |
During
the three months ended December 31, 2023, there were no RSUs granted, vested or forfeited. As of December 31, 2023, there is
no remaining unrecognized compensation expense as the RSUs vested on January 1, 2024.
On
January 1, 2024, 73,440 RSUs were granted, 100% of which vest on January 1, 2025.
The
following table summarizes RSA activity under the Plan:
Schedule of Restricted Stock Awards Activity
| |
| | |
Weighted | |
| |
| | |
Average Grant | |
| |
RSA | | |
Date
Fair Value | |
Unvested balance at December
31, 2023 | |
| 5,514 | | |
$ | 28.27 | |
During
the three months ended December 31, 2023, there were no RSAs granted, vested or forfeited. As of December 31, 2023, there is
no remaining unrecognized compensation expense as the RSAs vested on January 1, 2024.
On
January 1, 2024, 63,819 RSAs were granted, 100% of which vest on January 1, 2025.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.0.1
Income Taxes
|
3 Months Ended |
Dec. 31, 2023 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
8.
Income Taxes
In
August 2022, the U.S. enacted the Inflation Reduction Act of 2022 (“IRA”). The IRA contains a number of tax-related provisions
that will be effective for tax years beginning after December 31, 2022, including a corporate alternative minimum tax of 15% on certain
large corporations and an excise tax of 1% on corporate stock repurchases. The Company is currently evaluating the various provisions
of the IRA and does not anticipate a material impact on its consolidated financial statements.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.24.0.1
Subsequent Events
|
3 Months Ended |
Dec. 31, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
9.
Subsequent Events
The
Company has evaluated subsequent events from the balance sheet date through February 14, 2024, the date at which the unaudited interim
consolidated financial statements were available to be issued.
In
January 2024, the Company executed an agreement to sell $4.8 million of its New Jersey state net operating losses through the Program
for expected net proceeds of $4.3 million.
|
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.24.0.1
Summary of Significant Accounting Policies (Policies)
|
3 Months Ended |
Dec. 31, 2023 |
Accounting Policies [Abstract] |
|
Basis of presentation |
a. Basis of presentation
The
accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information as found in the Accounting Standards Codification (“ASC”)
and Accounting Standards Updates (ASUs”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management,
the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily
of accruals, estimates and assumptions that impact the unaudited interim consolidated financial statements) considered necessary to present
fairly the Company’s financial position as of December 31, 2023 and its results of operations and cash flows for the three
months ended December 31, 2023 and 2022. The unaudited interim consolidated financial statements presented herein do not contain the
required disclosures under U.S. GAAP for annual financial statements and should be read in conjunction with the annual audited financial
statements and related notes of Sonnet as of and for the year ended September 30, 2023 included in the Company’s Annual Report
on Form 10-K for the fiscal year ended September 30, 2023. The results of operations for the interim periods are not necessarily indicative
of the results of operations to be expected for the full year.
|
Consolidation |
b. Consolidation
The
unaudited interim consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany
accounts and transactions have been eliminated in consolidation.
|
Use of estimates |
c. Use of estimates
The
preparation of the unaudited interim consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Significant estimates
and assumptions reflected in these unaudited interim consolidated financial statements include the accrual of research and development
expenses. Estimates and assumptions are periodically reviewed in-light of changes in circumstances, facts and experience. Changes in
estimates are recorded in the period in which they become known. Actual results could differ from management’s estimates.
|
Incentive tax receivable |
d. Incentive tax receivable
Subsidiary
is eligible to participate in an Australian research and development tax incentive program. As part of this program, Subsidiary is eligible
to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by Subsidiary
in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian)
during the reimbursable period. The Company estimates the amount of cash refund it expects to receive related to the Australian research
and development tax incentive program and records the incentive when it is probable (i) the Company will comply with relevant conditions
of the program and (ii) the incentive will be received. As of December 31, 2023, the Company’s estimate of the amount of cash
refund it expects to receive for eligible spending related to the Australian research and development tax incentive program was $0.2 million.
For the three months ended December 31, 2023 and 2022, $0.2 million and $0.3 million, respectively, for the expected cash refund related
to the tax incentive program was included as an offset to research and development expenses. In December 2023, the Company received $0.8
million from the Australian government related to eligible research and development expenses for the year ended September 30, 2023.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
|
Property and equipment |
e. Property and equipment
Property
and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Expenditures
for repairs and maintenance that do not extend the estimated useful life or improve an asset are expensed as incurred. Upon retirement
or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts, and any
resulting gain or loss is included in the consolidated statement of operations.
|
Collaboration revenue |
f. Collaboration revenue
Collaboration
arrangements may contain multiple components, which may include (i) licenses; (ii) research and development activities; and (iii) the
manufacturing and supply of certain materials. Payments pursuant to these arrangements may include non-refundable payments, upfront payments,
milestone payments upon the achievement of significant regulatory and development events, sales milestones and royalties on product sales.
The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in
a future period.
In
determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under a collaboration arrangement,
the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of
whether the promised goods or services are performance obligations, including whether they are capable of being distinct; (iii) measurement
of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance
obligations; and (v) recognition of revenue as the Company satisfies each performance obligation.
The
Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating
transaction price to performance obligations within a contract, determining when performance obligations have been met, and assessing
the recognition of variable consideration. When consideration is received prior to the Company completing its performance obligation
under the terms of a contract, a contract liability is recorded as deferred income. Deferred income expected to be recognized as revenue
within the twelve months following the balance sheet date is classified as a current liability. In May 2021, the Company entered into
a License Agreement (the “New Life Agreement”) with New Life. See Note 5 for
further discussion of the New Life Agreement.
|
Research and development expense |
g. Research and development expense
Research
and development expenses include all direct and indirect costs associated with the development of the Company’s biopharmaceutical
products. These expenses include personnel costs, consulting fees, and payments to third parties for research, development, and manufacturing
services. These costs are charged to expense as incurred.
At
the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward
completion of the related project, based on the measure of progress as defined in the contract. Factors the Company considers in preparing
the estimates include costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of its service
providers. Such estimates are subject to change as additional information becomes available. Depending on the timing of payment to the
service providers and the progress that the Company estimates has been made as a result of the service provided, the Company will record
a prepaid expense or accrued liability relating to these costs. Upfront milestone payments made to third parties who perform research
and development services on the Company’s behalf are expensed as services are rendered. Contingent development or regulatory milestone
payments are recognized upon the related resolution of such contingencies.
|
Reverse stock split |
h. Reverse stock split
On
August 31, 2023, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary of
State of the State of Delaware, which effected a 1-for-22 reverse stock split of the Company’s issued and outstanding shares of
common stock. As a result of the reverse stock split, every 22 shares of common stock issued and outstanding was converted into one share
of common stock. The reverse stock split affected all stockholders uniformly and did not alter any stockholder’s percentage interest
in the Company’s equity. No fractional shares were issued in connection with the reverse stock split. Stockholders who would otherwise
be entitled to a fractional share of common stock were instead entitled to receive a proportional cash payment. The reverse stock split
did not change the par value or authorized number of shares of common stock. All common share and per share amounts presented in the
unaudited interim consolidated financial statements and accompanying notes have been retroactively adjusted to reflect the reverse stock
split.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
|
Net loss per share |
i. Net loss per share
Basic
net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each
period (and potential shares of common stock that are exercisable for little or no consideration). Included in basic weighted-average
number of shares of common stock outstanding during the three months ended December 31, 2023 are the pre-funded October 2023 warrants
to purchase 1,537,500 shares of common stock with an exercise price of $0.0001 per share. Included in basic weighted-average number of
shares of common stock outstanding during the three months ended December 31, 2022 are the Series B warrants to purchase 137 shares
of common stock with an exercise price of $0.0308 per share, which were net share settled in November 2022.
Diluted
loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and
stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average
number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities
are not included in the calculation as the impact is anti-dilutive.
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule of Potentially Dilutive Securities
| |
2023 | | |
2022 | |
| |
December
31, | |
| |
2023 | | |
2022 | |
Common stock warrants August 2021 | |
| 112,429 | | |
| 128,500 | |
Underwriter warrants August 2021 | |
| 2,287 | | |
| 2,287 | |
Private warrants | |
| — | | |
| 90 | |
Chanticleer warrants | |
| 57 | | |
| 57 | |
Series C warrants | |
| 18,391 | | |
| 36,778 | |
Series 3 warrants | |
| 12,548 | | |
| 12,548 | |
Unvested restricted stock units and awards | |
| 7,840 | | |
| 10,002 | |
Common stock warrants February 2023 | |
| 271,883 | | |
| — | |
Underwriter warrants February 2023 | |
| 15,466 | | |
| — | |
Common stock private placement warrants June
2023 | |
| 227,272 | | |
| — | |
Placement agent warrants June 2023 | |
| 6,818 | | |
| — | |
Common stock warrants October 2023 | |
| 5,687,500 | | |
| — | |
Underwriter warrants October 2023 | |
| 85,312 | | |
| — | |
Total anti-dilutive weighted
average shares | |
| 6,447,803 | | |
| 190,262 | |
|
Recent accounting pronouncements |
j. Recent accounting pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU
2023-07, which is applicable to entities with a single reportable segment, will primarily require enhanced disclosures about significant
segment expenses and enhanced disclosures in interim periods. The guidance in ASU 2023-07 will be applied retrospectively and is effective
for annual reporting periods in fiscal years beginning after December 15, 2023 and interim reporting periods in fiscal years beginning
after December 31, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-07
will have on its consolidated financial statements and disclosures.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 is intended
to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the
rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the
income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning
after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated
financial statements and disclosures.
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v3.24.0.1
Summary of Significant Accounting Policies (Tables)
|
3 Months Ended |
Dec. 31, 2023 |
Accounting Policies [Abstract] |
|
Schedule of Potentially Dilutive Securities |
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule of Potentially Dilutive Securities
| |
2023 | | |
2022 | |
| |
December
31, | |
| |
2023 | | |
2022 | |
Common stock warrants August 2021 | |
| 112,429 | | |
| 128,500 | |
Underwriter warrants August 2021 | |
| 2,287 | | |
| 2,287 | |
Private warrants | |
| — | | |
| 90 | |
Chanticleer warrants | |
| 57 | | |
| 57 | |
Series C warrants | |
| 18,391 | | |
| 36,778 | |
Series 3 warrants | |
| 12,548 | | |
| 12,548 | |
Unvested restricted stock units and awards | |
| 7,840 | | |
| 10,002 | |
Common stock warrants February 2023 | |
| 271,883 | | |
| — | |
Underwriter warrants February 2023 | |
| 15,466 | | |
| — | |
Common stock private placement warrants June
2023 | |
| 227,272 | | |
| — | |
Placement agent warrants June 2023 | |
| 6,818 | | |
| — | |
Common stock warrants October 2023 | |
| 5,687,500 | | |
| — | |
Underwriter warrants October 2023 | |
| 85,312 | | |
| — | |
Total anti-dilutive weighted
average shares | |
| 6,447,803 | | |
| 190,262 | |
|
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v3.24.0.1
Accrued Expenses and Other Current Liabilities (Tables)
|
3 Months Ended |
Dec. 31, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses and Other Current Liabilities |
Accrued
expenses and other current liabilities consisted of the following:
Schedule of Accrued Expenses and Other Current Liabilities
| |
December 31, | | |
September
30, | |
| |
2023 | | |
2023 | |
Compensation and benefits | |
$ | 141,636 | | |
$ | 2,091,196 | |
Research and development | |
| 564,674 | | |
| 913,145 | |
Professional fees | |
| 213,912 | | |
| 224,031 | |
Other | |
| 2,969 | | |
| 2,550 | |
Accrued expenses and
other current liabilities | |
$ | 923,191 | | |
$ | 3,230,922 | |
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v3.24.0.1
Stockholders’ Deficit (Tables)
|
3 Months Ended |
Dec. 31, 2023 |
Equity [Abstract] |
|
Schedule of Warrants Outstanding |
As
of December 31, 2023, the following equity-classified warrants and related terms were outstanding:
Schedule of Warrants Outstanding
| |
Warrants
Outstanding | | |
Exercise
Price | | |
Expiration
Date |
Common stock warrants August 2021 | |
| 112,429 | | |
$ | 261.80 | | |
August 24, 2026 |
Underwriter warrants August 2021 | |
| 2,287 | | |
$ | 327.25 | | |
August 19, 2026 |
Chanticleer warrants | |
| 57 | | |
$ | 18,018.00
- 28,028.00 | | |
April 30, 2027 - December 17, 2028 |
Series C warrants | |
| 18,391 | | |
$ | 982.52 | | |
October 16, 2025 |
Series 3 warrants | |
| 12,548 | | |
$ | 89.628 | | |
August 15, 2027 |
Common stock warrants February 2023 | |
| 271,883 | | |
$ | 23.76 | | |
February 10, 2028 |
Underwriter warrants February 2023 | |
| 15,466 | | |
$ | 29.70 | | |
February 8, 2028 |
Common stock private placement warrants June
2023 | |
| 227,272 | | |
$ | 14.8478 | | |
December 30, 2026 |
Placement agent warrants June 2023 | |
| 6,818 | | |
$ | 14.8478 | | |
December 30, 2026 |
Common stock warrants October 2023 | |
| 5,687,500 | | |
$ | 1.60 | | |
October 27, 2028 |
Pre-funded warrants October 2023 | |
| 1,537,500 | | |
$ | 0.0001 | | |
— |
Underwriter warrants October 2023 | |
| 85,312 | | |
$ | 2.00 | | |
October 24, 2028 |
Total | |
| 7,977,463 | | |
| | | |
|
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v3.24.0.1
Share-Based Compensation (Tables)
|
3 Months Ended |
Dec. 31, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Share-based Compensation Expense |
The
Company recorded share-based compensation expense associated with the RSUs and RSAs in its accompanying unaudited interim consolidated
statements of operations as follows:
Schedule of Share-based Compensation Expense
| |
2023 | | |
2022 | |
| |
Three
Months Ended December 31, | |
| |
2023 | | |
2022 | |
Research and development | |
$ | 24,554 | | |
$ | 46,708 | |
General and administrative | |
| 25,451 | | |
| 44,909 | |
Share Based Compensation | |
$ | 50,005 | | |
$ | 91,617 | |
|
Schedule of Restricted Stock Units Activity |
The
following table summarizes RSU activity under the Plan:
Schedule of Restricted Stock Units Activity
| |
| | |
Weighted | |
| |
| | |
Average Grant | |
| |
RSU | | |
Date
Fair Value | |
Unvested balance at December
31, 2023 | |
| 2,326 | | |
$ | 21.78 | |
|
Schedule of Restricted Stock Awards Activity |
The
following table summarizes RSA activity under the Plan:
Schedule of Restricted Stock Awards Activity
| |
| | |
Weighted | |
| |
| | |
Average Grant | |
| |
RSA | | |
Date
Fair Value | |
Unvested balance at December
31, 2023 | |
| 5,514 | | |
$ | 28.27 | |
|
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v3.24.0.1
Organization and Description of Business (Details Narrative) - USD ($)
|
3 Months Ended |
|
Dec. 31, 2023 |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
Cash |
$ 3,021,392
|
$ 2,274,259
|
Net operating losses |
4,800,000
|
|
Proceeds from sale of net operating losses |
$ 4,300,000
|
|
X |
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v3.24.0.1
Schedule of Potentially Dilutive Securities (Details) - shares
|
3 Months Ended |
Dec. 31, 2023 |
Dec. 31, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
6,447,803
|
190,262
|
Common Stock Warrants August 2021 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
112,429
|
128,500
|
Underwriter Warrants August 2021 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
2,287
|
2,287
|
Private Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
|
90
|
Chanticleer Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
57
|
57
|
Series C Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
18,391
|
36,778
|
Series 3 Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
12,548
|
12,548
|
Unvested Restricted Stock Units and Awards [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
7,840
|
10,002
|
Common Stock Warrants February 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
271,883
|
|
Underwriter Warrants February 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
15,466
|
|
Common Stock Private Placement Warrants June 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
227,272
|
|
Placement Agent Warrants June 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
6,818
|
|
Common Stock Warrants October 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
5,687,500
|
|
Underwriter Warrants October 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
85,312
|
|
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v3.24.0.1
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
|
Aug. 31, 2023 |
Dec. 31, 2023 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Sep. 30, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Incentive tax receivable, description |
|
|
The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian)
during the reimbursable period.
|
|
|
Incentive tax receivable |
|
$ 194,111
|
$ 194,111
|
|
$ 786,574
|
Cash refund expected to be received |
|
|
$ 200,000
|
$ 300,000
|
|
Proceeds from income tax refunds |
|
$ 800,000
|
|
|
|
Stockholders equity reverse stock split |
1-for-22 reverse stock split
|
|
|
|
|
Prefunded Warrant [Member] | October Offering [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Warrants to purchase |
|
1,537,500
|
1,537,500
|
|
|
Exercise price |
|
$ 0.0001
|
$ 0.0001
|
|
|
Series B Warrant [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Warrants to purchase |
|
|
|
137
|
|
Exercise price |
|
|
|
$ 0.0308
|
|
Research And Development Tax Incentive Program [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Incentive tax receivable |
|
$ 200,000
|
$ 200,000
|
|
|
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v3.24.0.1
Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($)
|
Dec. 31, 2023 |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
|
Compensation and benefits |
$ 141,636
|
$ 2,091,196
|
Research and development |
564,674
|
913,145
|
Professional fees |
213,912
|
224,031
|
Other |
2,969
|
2,550
|
Accrued expenses and other current liabilities |
$ 923,191
|
$ 3,230,922
|
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v3.24.0.1
Commitments and Contingencies (Details Narrative) € in Millions |
1 Months Ended |
3 Months Ended |
|
|
|
|
Apr. 30, 2022
USD ($)
|
Mar. 31, 2022
USD ($)
|
Dec. 31, 2021
USD ($)
|
Dec. 31, 2023
USD ($)
|
Dec. 31, 2022
USD ($)
|
Dec. 31, 2023
EUR (€)
|
Apr. 30, 2023
USD ($)
|
Jan. 31, 2019
USD ($)
|
Jul. 31, 2012
USD ($)
|
Discovery Collaboration Agreements [Member] | XOMA [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
|
|
|
|
|
$ 3,800,000
|
Discovery Collaboration Agreements [Member] | XOMA [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
License fee |
$ 500,000
|
|
|
|
|
|
|
|
|
License fees |
|
|
|
$ 0
|
$ 0
|
|
|
|
|
Cellca Agreement [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Description of milestone payments |
|
|
|
The Company is obligated to make milestone payments to Cellca totaling up to $0.7 million upon the achievement of certain development
and approval milestones if the Buy-Out Option is not exercised.
|
|
|
|
|
|
Cellca Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
|
|
|
|
$ 700,000
|
|
The Cellca Agreement [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
$ 600,000
|
|
|
|
|
|
The Cellca Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Payment for annual license fee obligation |
|
|
|
600,000
|
|
|
|
|
|
The Cellca Agreement [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Payment for annual license fee obligation |
|
|
|
100,000
|
|
|
|
|
|
The Cellca Agreement [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
License fees |
$ 100,000
|
|
|
0
|
0
|
|
|
|
|
The Brink Agreement [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Payment of annual license fee |
|
|
|
|
|
|
$ 12,000
|
|
|
Commercial product license fee payment obligation |
|
|
|
100,000
|
|
|
|
|
|
The Brink Agreement [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
License fee |
|
|
|
12,000
|
|
|
|
|
|
License fees |
|
|
|
|
0
|
|
|
|
|
Development license fee payments |
|
|
|
100,000
|
|
|
|
|
|
InvivoGen Agreement [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
License fees |
|
|
|
0
|
0
|
|
|
|
|
Payment for annual license fee obligation |
|
|
|
100,000
|
|
€ 0.1
|
|
|
|
ProteoNic Agreement [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
1,300,000
|
|
€ 1.2
|
|
|
|
License fees |
|
|
|
0
|
0
|
|
|
|
|
ProteoNic Agreement [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
License fees |
|
$ 24,600
|
|
|
|
|
|
|
|
Navigo Agreement [Member] | Navigo Proteins GmbH [Member] | Technology Service [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
1,000,000.0
|
|
|
|
|
|
Payment to acquire in process research and development |
|
|
$ 100,000
|
|
|
|
|
|
|
Navigo Agreement [Member] | Navigo Proteins GmbH [Member] | Technology Service [Member] | Research and Development Expense [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
License fees |
|
|
|
$ 0
|
$ 100,000
|
|
|
|
|
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v3.24.0.1
Collaboration Revenue (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
Jun. 30, 2021 |
Aug. 31, 2020 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Collavorative arrangement right and obligation |
|
|
New Life is also obligated to pay a non-refundable deferred license fee of an additional $1.0 million at the time of the satisfaction
of certain milestones, as well as potential additional milestone payments to the Company of up to $19.0 million subject to the achievement
of certain development and commercialization milestones. In addition, during the Royalty Term (as defined below), New Life is obligated
to pay the Company tiered double-digit royalties ranging from 12% to 30% based on annual net sales of Products in the Exclusive Territory.
The “Royalty Term” means, on a Product-by-Product and a country-by-country basis in the Exclusive Territory, the period commencing
on the date of the first commercial sale (subject to certain conditions) of such Product in such country in the Exclusive Territory and
continuing until New Life ceases commercialization of such Product in the DIPN Field
|
|
Performance obligation |
|
|
$ 1,000,000.0
|
|
Collaboration revenue |
|
|
18,626
|
$ 37,255
|
License Agreement [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Proceeds for negotiate license agreement |
|
$ 500,000
|
|
|
New Life Agreement [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Proceeds for negotiate license agreement |
$ 500,000
|
|
|
|
Future milestone payments |
|
|
1,000,000.0
|
|
Milestone payments |
|
|
$ 19,000,000.0
|
|
New Life Agreement [Member] | Minimum [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Royalties, percentage |
|
|
12.00%
|
|
New Life Agreement [Member] | Maximum [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Royalties, percentage |
|
|
30.00%
|
|
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v3.24.0.1
Schedule of Warrants Outstanding (Details)
|
Dec. 31, 2023
$ / shares
shares
|
Common Stock Warrants August 2021 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
112,429
|
Exercise Price | $ / shares |
$ 261.80
|
Expiration date |
Aug. 24, 2026
|
Underwriter Warrants August 2021 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
2,287
|
Exercise Price | $ / shares |
$ 327.25
|
Expiration date |
Aug. 19, 2026
|
Chanticleer Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
57
|
Chanticleer Warrants [Member] | Minimum [Member] |
|
Class of Warrant or Right [Line Items] |
|
Exercise Price | $ / shares |
$ 18,018.00
|
Expiration date |
Apr. 30, 2027
|
Chanticleer Warrants [Member] | Maximum [Member] |
|
Class of Warrant or Right [Line Items] |
|
Exercise Price | $ / shares |
$ 28,028.00
|
Expiration date |
Dec. 17, 2028
|
Series C Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
18,391
|
Exercise Price | $ / shares |
$ 982.52
|
Expiration date |
Oct. 16, 2025
|
Series 3 Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
12,548
|
Exercise Price | $ / shares |
$ 89.628
|
Expiration date |
Aug. 15, 2027
|
Common Stock Warrants February 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
271,883
|
Exercise Price | $ / shares |
$ 23.76
|
Expiration date |
Feb. 10, 2028
|
Underwriter Warrants February 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
15,466
|
Exercise Price | $ / shares |
$ 29.70
|
Expiration date |
Feb. 08, 2028
|
Common Stock Private Placement Warrants June 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
227,272
|
Exercise Price | $ / shares |
$ 14.8478
|
Expiration date |
Dec. 30, 2026
|
Placement Agent Warrants June 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
6,818
|
Exercise Price | $ / shares |
$ 14.8478
|
Expiration date |
Dec. 30, 2026
|
Common Stock Warrants October 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
5,687,500
|
Exercise Price | $ / shares |
$ 1.60
|
Expiration date |
Oct. 27, 2028
|
Prefunded Warrants October 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
1,537,500
|
Exercise Price | $ / shares |
$ 0.0001
|
Underwriter Warrants October 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
85,312
|
Exercise Price | $ / shares |
$ 2.00
|
Expiration date |
Oct. 24, 2028
|
Warrant [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
7,977,463
|
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v3.24.0.1
Stockholders’ Deficit (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
Oct. 26, 2023 |
Aug. 15, 2022 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Proceeds from sale of common stock |
|
|
$ 3,838,870
|
$ 4,562,895
|
Offering price for common stock |
|
|
3,916,943
|
$ 4,452,012
|
Warrant expirations |
|
|
|
242
|
2022 Sales Agreement [Member] |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Offering price for common stock |
|
$ 7,800,000
|
|
|
2022 Sales Agreement [Member] | BTIG, LLC [Member] |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Proceeds from sale of common stock |
|
|
|
$ 4,500,000
|
Sale of stock, shares |
|
|
|
109,841
|
Offering price for common stock |
|
$ 25,000,000.0
|
|
|
Gross proceeds from sale agreement |
|
|
|
$ 4,800,000
|
Common Stock [Member] |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Offering price for common stock |
|
|
$ 131
|
$ 11
|
Net share settlement of warrants, shares |
|
|
14,362
|
137
|
Sale of common stock, net of issuance costs, shares |
|
|
1,306,250
|
109,841
|
Common Stock Warrants [Member] |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Net share settlement of warrants, shares |
|
|
28,724
|
137
|
Sale of common stock, net of issuance costs, shares |
|
|
14,362
|
137
|
Warrants Holder [Member] |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Forfeited warrants, shares |
|
|
34,458
|
|
October Offering [Member] | Prefunded Warrant [Member] |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Purchase of warrants |
|
|
1,537,500
|
|
Exercisable price |
|
|
$ 0.0001
|
|
October Offering [Member] | Underwriters [Member] |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Proceeds from sale of common stock |
$ 3,900,000
|
|
|
|
Purchase of warrants |
85,312
|
|
|
|
Exercisable price |
$ 2.00
|
|
|
|
October Offering [Member] | Underwriters [Member] | Common Stock [Member] |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Sale of stock, shares |
1,306,250
|
|
|
|
Exercisable price |
$ 0.0001
|
|
|
|
October Offering [Member] | Underwriters [Member] | Prefunded Warrant [Member] |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Purchase of warrants |
1,537,500
|
|
|
|
Sale price |
$ 1.5999
|
|
|
|
October Offering [Member] | Underwriters [Member] | Common Warrant [Member] |
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
Purchase of warrants |
5,687,500
|
|
|
|
Sale price |
$ 1.60
|
|
|
|
Exercisable price |
$ 1.60
|
|
|
|
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v3.24.0.1
Share-Based Compensation (Details Narrative) - shares
|
1 Months Ended |
|
|
Jan. 31, 2024 |
Jan. 01, 2024 |
Dec. 31, 2023 |
Subsequent Event [Member] | Restricted Stock Units (RSUs) [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Restricted stock units and vesting rights, description |
On
January 1, 2024, 73,440 RSUs were granted, 100% of which vest on January 1, 2025
|
|
|
Number of shares granted |
73,440
|
|
|
Vesting percentage |
100.00%
|
|
|
Subsequent Event [Member] | Restricted Stock Award [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Restricted stock units and vesting rights, description |
On
January 1, 2024, 63,819 RSAs were granted, 100% of which vest on January 1, 2025
|
|
|
Number of shares granted |
63,819
|
|
|
Vesting percentage |
100.00%
|
|
|
2020 Omnibus Equity Incentive Plan [Member] | Common Stock [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Number of shares available for issuance |
|
|
14,480
|
2020 Omnibus Equity Incentive Plan [Member] | Common Stock [Member] | Subsequent Event [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Number of shares available for issuance |
|
122,780
|
|
X |
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Sonnet BioTherapeutics (NASDAQ:SONN)
Graphique Historique de l'Action
De Août 2024 à Sept 2024
Sonnet BioTherapeutics (NASDAQ:SONN)
Graphique Historique de l'Action
De Sept 2023 à Sept 2024