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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 |
For
the quarterly period ended June 30, 2022.
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:
001-32188
ORAGENICS, INC.
(Exact
name of registrant as specified in its charter)
florida |
|
59-3410522 |
(State
or other jurisdiction of
incorporation
or organization)
|
|
(IRS
Employer
Identification
No.)
|
4902 Eisenhower Blvd.,
Suite 125
Tampa,
Florida
33634
(Address
of principal executive offices)
813-286-7900
(Issuer’s
telephone number)
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 |
|
OGEN |
|
NYSE American |
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 and
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, non-accelerated filer, a smaller reporting
company, or an emerging growth company. See definition of
“accelerated filer”, “large accelerated filer”, “smaller reporting
company” and “emerging growth company” in Rule 12b-2 of the
Exchange Act (check one):
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 ☒
Indicate
the number of shares outstanding of each of the issuer’s classes of
common equity, as of the latest practicable date:
As of
August 8, 2022, there were 116,394,806
shares of Common Stock, $.001 par value, outstanding.
PART I – |
FINANCIAL
INFORMATION |
|
|
ITEM
1. |
FINANCIAL
STATEMENTS |
Oragenics, Inc.
Consolidated
Balance Sheets
See
accompanying notes.
Oragenics, Inc.
Consolidated
Statements of Operations
(Unaudited)
See
accompanying notes.
Oragenics, Inc.
Consolidated
Statements of Changes in Shareholders’ Equity
(Unaudited)
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
Total |
|
|
|
Common Stock |
|
|
Preferred Stock |
|
|
Paid
In |
|
|
Accumulated |
|
|
Shareholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Equity |
|
Balances at December
31, 2020 |
|
|
91,766,928 |
|
|
$ |
91,767 |
|
|
|
16,017,133.483 |
|
|
$ |
7,174,854 |
|
|
$ |
164,022,957 |
|
|
$ |
(154,444,983 |
) |
|
$ |
16,844,595 |
|
Compensation
expense
relating to option issuances |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,123,761 |
|
|
|
— |
|
|
|
1,123,761 |
|
Series C
dividend |
|
|
— |
|
|
|
— |
|
|
|
33.016 |
|
|
|
1,117,531 |
|
|
|
— |
|
|
|
(1,117,531 |
) |
|
|
— |
|
Series C
redemption |
|
|
|
|
|
|
|
|
|
|
(166.499 |
) |
|
|
(5,635,672 |
) |
|
|
|
|
|
|
|
|
|
|
(5,635,672 |
) |
ATM offering - net
of expenses |
|
|
21,398,765 |
|
|
|
21,399 |
|
|
|
— |
|
|
|
— |
|
|
|
26,654,993 |
|
|
|
— |
|
|
|
26,676,392 |
|
Issuance of common
stock from warrant exercise |
|
|
2,472,573 |
|
|
|
2,472 |
|
|
|
— |
|
|
|
— |
|
|
|
2,258,864 |
|
|
|
— |
|
|
|
2,261,336 |
|
Net
loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5,219,945 |
) |
|
|
(5,219,945 |
) |
Balances at March 31, 2021 |
|
|
115,638,266 |
|
|
|
115,638 |
|
|
|
16,017,000 |
|
|
|
2,656,713 |
|
|
|
194,060,575 |
|
|
|
(160,782,459 |
) |
|
|
36,050,467 |
|
Compensation
expense
relating to option issuances |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
231,140 |
|
|
|
— |
|
|
|
231,140 |
|
Issuance of common
stock from option exercise |
|
|
556,540 |
|
|
|
557 |
|
|
|
— |
|
|
|
— |
|
|
|
266,583 |
|
|
|
— |
|
|
|
267,140 |
|
Net
loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(3,815,347 |
) |
|
|
(3,815,347 |
) |
Balances at June 30, 2021 |
|
|
116,194,806 |
|
|
|
116,195 |
|
|
|
16,017,000 |
|
|
|
2,656,713 |
|
|
|
194,558,298 |
|
|
|
(164,597,806 |
) |
|
|
32,733,400 |
|
See
accompanying notes.
Oragenics, Inc.
Consolidated
Statements of Cash Flows
(Unaudited)
See
accompanying notes.
Oragenics, Inc.
Notes
to Consolidated Financial Statements
(Unaudited)
1.
Organization
Oragenics,
Inc. (the “Company” or “we”) is focused on the development of the
NT-CoV2-1 intranasal vaccine candidate to combat the novel Severe
Acute Respiratory Syndrome coronavirus (“SARS-CoV-2”) and further
development of effective treatments for novel antibiotics against
infectious disease.
2.
Basis of
Presentation
The
accompanying unaudited interim consolidated financial statements as
of June 30, 2022 and December 31, 2021 (audited) and three and six
months ended June 30, 2022 and 2021, have been prepared in
accordance with accounting principles generally accepted in the
United States of America (“US GAAP”) for interim consolidated
financial information and with the instructions to Form 10-Q and
Article 8 of Regulation S-X. Accordingly, they do not include all
of the information and footnotes required by US GAAP for complete
consolidated financial statements. In the opinion of management,
the accompanying consolidated financial statements include all
adjustments, consisting of normal recurring accruals, necessary for
a fair presentation of the financial condition, results of
operations and cash flows for the periods presented. The results of
operations for the interim period ended June 30, 2022, are not
necessarily indicative of the results of operations that may be
expected for the year ended December 31, 2022, or any future
period.
These
consolidated financial statements should be read in conjunction
with the audited financial statements and notes thereto for the
year ended December 31, 2021, which are included in our Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on March 24, 2022. The Company has incurred recurring
losses and negative cash flows from operations since inception. To
date, the Company has not generated significant revenues from
operations. The Company incurred a net loss of $10,068,087 and used cash of $9,019,757 in its operating
activities during the six months ended June 30, 2022. As of June
30, 2022, the Company had an accumulated deficit of $181,342,215.
The
Company expects to incur substantial expenditures to further
develop its technologies. The Company believes the working capital
at June 30, 2022 will be sufficient to meet the business objectives
as presently structured through the fourth quarter of 2022. As
such, there is substantial doubt that we can continue as a going
concern beyond that date.
The
Company’s ability to continue operations after its current cash
resources are exhausted depends on its ability to obtain additional
financing or achieve profitable operations, as to which no
assurances can be given. Cash requirements may vary materially from
those now planned because of changes in the Company’s focus and
direction of its research and development programs, competitive and
technical advances, or other developments. Additional financing
will be required to continue operations after the Company exhausts
its current cash resources and to continue its long-term plans for
clinical trials and new product development. There can be no
assurance that any such financing can be realized by the Company,
or if realized, what the terms thereof may be, or that any amount
that the Company is able to raise will be adequate to support the
Company’s working capital requirements until it achieves profitable
operations.
The
Company intends to seek additional funding through sublicensing
arrangements, joint venturing or partnering, sales of rights to
technology, government grants and public or private financings. The
Company’s future success depends on its ability to raise capital
and ultimately generate revenue and attain profitability. The
Company cannot be certain that additional capital, whether through
selling additional debt or equity securities or obtaining a line of
credit or other loan, will be available to it or, if available,
will be on terms acceptable to the Company. If the Company issues
additional securities to raise funds, these securities may have
rights, preferences, or privileges senior to those of its common
stock, and the Company’s current shareholders may experience
dilution. If the Company is unable to obtain funds when needed or
on acceptable terms, the Company may be required to curtail its
current development programs, cut operating costs and forego future
development and other opportunities.
3.
Significant Accounting
Policies
Basis of Consolidation
The
consolidated financial statements include the accounts of
Oragenics, Inc. and our wholly-owned subsidiary Noachis Terra,
Inc.(“NTI”). All intercompany balances and transactions have been
eliminated.
New Accounting Standards
There
are no additional accounting pronouncements issued or effective
during the three and six months ended June 30, 2022, that have had,
or are expected to have, a material impact on our consolidated
financial statements.
Use of Estimates
The
preparation of consolidated financial statements in conformity with
US GAAP requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the
consolidated financial statements, as well as the reported amounts
of expenses during the reporting period. Actual results could
differ from those estimates. The principal area of estimation
reflected in the consolidated financial statements is stock-based
compensation.
Stock-Based Payment Arrangements
Generally,
all forms of stock-based payments, including stock option grants,
and warrants are measured at their fair value on the awards’ grant
date using a Black-Scholes pricing model. Stock-based compensation
awards issued to non-employees for services rendered are recorded
at the fair value of the stock-based payment. The expense resulting
from stock-based payments are recorded in research and development
expense or general and administrative expense in the consolidated
statement of operations, depending on the nature of the services
provided. Stock-based payment expense is recorded over the
requisite service period in which the grantee provides services to
us. To the extent the stock option grants, or warrants do not vest
at the grant date they are subject to forfeiture.
Stock-Based Compensation
US
GAAP requires all stock-based payments to employees, including
grants of employee stock options, to be recognized in the
consolidated financial statements based on their fair values as of
the grant date. Stock-based compensation expense is recorded over
the requisite service period in which the grantee provides services
to us, to the extent the options do not vest at the grant date and
are subject to forfeiture. For performance-based awards that do not
include market-based conditions, we record share-based compensation
expense only when the performance-based milestone is deemed
probable of achievement. We utilize both quantitative and
qualitative criteria to judge whether milestones are probable of
achievement. For awards with market-based performance conditions,
we recognize the grant-date fair value of the award over the
derived service period regardless of whether the underlying
performance condition is met. In connection with adopting ASU
2016-09, the Company made an accounting policy election to account
for forfeitures in compensation expense as they occur.
Warrants
The
Company used the Black Scholes Option Pricing Model in calculating
the relative fair value of any warrants that have been
issued.
Net Loss Per Share
During
all periods presented, the Company had securities outstanding that
could potentially dilute basic earnings per share in the future but
were excluded from the computation of diluted net loss per share,
as their effect would have been antidilutive because the Company
reported a net loss for all periods presented. Basic and diluted
net loss per share amounts are the same for the periods presented.
Net loss per share is computed using the weighted average number of
shares of common stock outstanding.
Concentrations
Financial
instruments which potentially subject the Company to concentrations
of credit risk consist principally of cash and cash equivalents.
The Company maintains cash accounts in commercial banks, which may,
at times, exceed federally insured limits. The Company has not
experienced any losses in such accounts. The Company believes it is
not exposed to any significant credit risk on cash and cash
equivalents. As of June 30, 2022, the uninsured portion of this
balance was $17,617,483. As of
December 31, 2021, the uninsured portion of this balance was
$27,015,703.
Grant Revenue
Grant
revenues are derived from a small business innovation research
grant in the amount of $250,000 (“Computer-aided Design for Improved
Lantibiotics” R41GM136034. The Company recognizes grant revenue as
reimbursable grant costs are incurred up to the pre-approved award
limits within the budget period. The costs associated with these
reimbursements are reflected as a component of research and
development expenses in the accompanying consolidated statement of
operations.
4.
Stock-based
Compensation
The
Company recognized stock-based compensation on all employee and
non-employee awards as follows:
Schedule of Stock Based Compensation Expenses
Recognized
|
|
For the Three Months Ended June 30, 2022 |
|
|
For the Three Months Ended June 30, 2021 |
|
|
For the Six Months Ended June 30, 2022 |
|
|
For the Six Months Ended June 30, 2021 |
|
Research and
development |
|
$ |
26,399 |
|
|
$ |
48,761 |
|
|
$ |
65,854 |
|
|
$ |
79,688 |
|
General and
administrative |
|
|
252,589 |
|
|
|
182,379 |
|
|
|
303,381 |
|
|
|
1,275,213 |
|
Total
Stock-based compensation |
|
$ |
278,988 |
|
|
$ |
231,140 |
|
|
$ |
369,235 |
|
|
$ |
1,354,901 |
|
The
following table summarizes the stock option activity during the six
months ended June 30, 2022:
Summary of Stock Option
Activity
|
|
Number of Shares |
|
|
Weighted Average Exercise Price |
|
|
Weighted Average Remaining Contractual Term (In Years) |
|
|
Aggregate Intrinsic Value(1) |
|
Outstanding at December 31, 2021 |
|
|
6,724,402 |
|
|
$ |
0.95 |
|
|
|
7.99 |
|
|
$ |
2,773 |
|
Granted |
|
|
1,382,500 |
|
|
|
0.32 |
|
|
|
— |
|
|
$ |
— |
|
Exercised |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
$ |
— |
|
Expired |
|
|
(4,500 |
) |
|
|
12.00 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(726,998 |
) |
|
|
0.94 |
|
|
|
— |
|
|
$ |
— |
|
Outstanding at June 30, 2022 |
|
|
7,375,404 |
|
|
$ |
0.83 |
|
|
|
8.06 |
|
|
$ |
72,050 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at June 30, 2022 |
|
|
5,952,900 |
|
|
$ |
0.89 |
|
|
|
7.74 |
|
|
$ |
36,300 |
|
(1) |
|
The
aggregate intrinsic value is calculated as the difference between
the exercise price of the underlying stock option awards and the
closing market price of our common stock as of December 31, 2021
and June, 2022, respectively. |
Total
unrecognized compensation cost related to unvested stock options
was $436,162
as of June 30, 2022 and is expected to be recognized over a
weighted-average period of less than two years.
On February 25, 2022, the Company held its reconvened 2020 Annual
Meeting. At the reconvened 2020Annual Meeting, the shareholders of
the Company approved and ratified the Company’s 2021 Equity
Incentive Plan (the “2021 Plan”) which is a successor to the
Company’s 2012 Equity Incentive Plan (the “2012 Plan”).The 2021
Plan provides the aggregate number of shares of Common Stock that
may be issued under the 2021 Plan will not exceed the sum of (i)
10,000,000 new shares,
(ii) the number of shares remaining available for the grant of new
awards under the 2012 Plan as of immediately prior to the effective
date of the 2021 Plan, and (iii) certain shares subject to
outstanding awards granted under the 2012 Plan that may become
available for issuance under the 2021 Plan, as such shares become
available from time to time. As of
June 30, 2022, 9,877,306 shares of
common stock are available for future awards under the 2021
Plan.
Each
executive officer and non-employee director receiving equity-based
awards is subject to a minimum dollar value stock ownership holding
requirement with respect to the awards received as well as all
prior equity awards under the Plan which requirements are intended
to align the ability to sell shares with the performance of the
Company’s stock price. The executive officer recipients each have a
minimum dollar value stock ownership holding requirement threshold
equal to two times (2x) their then base salaries below which dollar
threshold they would be precluded from selling any shares of
Company stock obtained from the Company under its Plan. Also, the
non-employee directors are each subject to a minimum dollar value
stock ownership holding requirement threshold equal to six times
the annual Board retainer ($270,000)
below which dollar threshold they would be precluded from selling
shares of Company stock acquired from the Company under its
Plan.
5.
Warrants
During the three months ended March 31, 2021, the
Company issued an additional 2,472,573
shares of common stock as a result of the exercise of certain
outstanding warrants as follows: (i) warrants to acquire 360,000
shares of Common Stock at an exercise price of $1.00 per share
were exercised and (ii) warrants to acquire 2,112,573
shares of Common Stock at an exercise price of $0.90 per share
were exercised. The warrant exercises provided aggregate gross
proceeds to the Company of $2,261,336.
A
summary of warrant activity for the year ended December 31, 2021
and the six months ended June 30, 2022 is as follows:
Schedule of Warrants
Activity
|
|
Warrants |
|
|
Weighted
Average
Price
|
|
Balance - December 31, 2020 |
|
|
20,513,145 |
|
|
$ |
1.36 |
|
Granted |
|
|
— |
|
|
|
— |
|
Exercised |
|
|
(2,472,573 |
) |
|
|
0.91 |
|
Expired |
|
|
— |
|
|
|
— |
|
Balance - December 31, 2021 |
|
|
18,040,572 |
|
|
|
1.42 |
|
Granted |
|
|
— |
|
|
|
— |
|
Exercised |
|
|
— |
|
|
|
— |
|
Expired |
|
|
— |
|
|
|
— |
|
Balance - June 30, 2022 |
|
|
18,040,572 |
|
|
$ |
1.42 |
|
The
warrants outstanding as of June 30, 2022 are as follows:
Schedule of Warrants
Outstanding
Exercise Price |
|
|
Warrants
Outstanding
|
|
|
Expiration
Date
|
$ |
3.10 |
|
|
|
48,387 |
|
|
9/19/2022 |
$ |
2.00 |
|
|
|
900,000 |
|
|
4/10/2023 |
$ |
3.10 |
|
|
|
462,106 |
|
|
5/10/2024 |
$ |
3.10 |
|
|
|
602,414 |
|
|
7/25/2024 |
$ |
3.10 |
|
|
|
1,064,518 |
|
|
11/8/2024 |
$ |
1.00 |
|
|
|
3,174,500 |
|
|
7/17/2025 |
$ |
0.90 |
|
|
|
2,588,647 |
|
|
3/25/2024 |
$ |
1.25 |
|
|
|
9,200,000 |
|
|
5/1/2025 |
|
|
|
|
|
18,040,572 |
|
|
|
All
outstanding warrants are classified as equity on the Company’s
Consolidated Balance Sheets.
6.
Short-Term Notes
Payable
As of
June 30, 2022 and December 31, 2021, the Company had $— and
$303,416, respectively, in
short-term notes payable for the financing of various insurance
policies.
Products
Liability Insurance
The
product liability insurance policy has been renewed in subsequent
periods without premium financing.
Directors’
and Officers’ Insurance
On
July 24, 2021, the Company entered into a short-term note payable
for $600,169 bearing interest at
5.34% to finance a portion of the
directors’ and officers’ liability insurance and employment
practices liability insurance premiums. Principal and interest
payments on this note began August 24, 2021 and are made evenly
based on a straight-line amortization over a 10-month period with the final
payment being made on May 16, 2022.
On
July 24, 2020, the Company entered into a short-term note payable
for $413,784 bearing interest at
5.39% to finance a portion of the
directors’ and officers’ liability insurance and employment
practices liability insurance premiums. Principal and interest
payments on this note began August 24, 2020 and were made evenly
based on a straight-line amortization over an 11-month period with the final
payment being made on June 28, 2021.
7.
Commitments and
Contingencies
Additional
Consideration-NTI Acquisition
In
connection with the Company’s acquisition of NTI in May of 2020,
the Company is obligated to pay the former sole shareholder of NTI
contingent consideration based upon the exercise of certain of the
Company’s outstanding warrants as follows: (i) twenty percent
(20%) of the cash
proceeds received by the Company upon exercise of the Company’s
warrants carrying an exercise price of $0.75 and
$0.90 and (ii)
forty-five percent (45%) of the cash
proceeds received by the Company upon exercise of the Company’s
warrants carrying an exercise price of $1.00, in each
case, for so long as the warrants remain outstanding.
The Company’s previously
issued warrants carrying an exercise price of $0.75 have expired by
their terms. As a result, no additional consideration will be due
to the former sole shareholder of NTI relating to these
warrants.
During the three months ended March 31, 2021, 2,472,573 warrants were
exercised as follows: (i) 360,000 shares at an exercise
price of $1.00 per share and
(ii) 2,112,573 at an exercise price
of $0.90 per share.
See Note 9. Shareholders’ Equity.
As a
result of the warrant exercises in 2021, the Company paid
$542,263 of additional
consideration to the sole former shareholder of NTI. The additional
consideration payment is included in research and development
expenses.
During the three months ended June 30, 2022, no warrants were
exercised that resulted in the payment of
additional consideration to the sole former shareholder of
NTI.
NIH
License
Through
NTI, the Company is a party to a Patent License and Biological
Materials License Agreement (the “NIH License Agreement” or “NIH
License”), dated March 23, 2020, with the United States Department
of Health and Human Services (the “HHS”), as represented by the
National Institute of Allergy and Infectious Diseases (“NIAID”), an
Institute within the National Institutes of Health (“NIH”). Under
the terms of the NIH License Agreement, we hold a nonexclusive,
worldwide license to certain specified patent rights (including
patent applications, provisional patent applications and Patent
Cooperation Treaty (“PCT”) patent applications) and biological
materials relating to the use of pre-fusion coronavirus spike
proteins to exploit products (“Licensed Products”) and practice
processes (“Licensed Processes”) that are covered by the licensed
patent rights and biological materials for the purpose of
developing and commercializing a vaccine product candidate for
SARS-CoV-2.
Under
the terms of the NIH License Agreement, the NIAID is entitled to
receive a non-creditable, nonrefundable upfront license issue
royalty of $30,000 and reimbursement of
$11,739 for our pro rata share
of the NIAID’s past and future patent prosecution-related expenses
(which amounts have already been paid). Additionally, the NIAID is
entitled to receive lump sum nonrefundable minimum annual
royalties, which increase in the year after the first commercial
sale of any Licensed Products or the practice of any Licensed
Processes, as well as lump sum benchmark royalties following our
completion of certain commercial development and sales-related
benchmarks. The NIH is entitled to receive earned royalties on the
annual net sales of Licensed Products and the practice of any
Licensed Processes (subject to certain reductions), at certain low-
to mid-single digit royalty rates, which rates vary based on the
total amount of annual net sales and the geographic market in which
those sales occur. We must provide regular written reports to the
NIAID on the development status of and royalty payments relating to
the Licensed Products and the Licensed Processes.
The
NIH License Agreement will expire upon (a) twenty (20) years from the first
commercial sale where no licensed patent rights exist or have
ceased to exist or (b) the expiration of the last patent contained
in the licensed patent rights, unless terminated earlier. None of
the applications included in the NIH licensed patent rights have
issued yet. The NIH may terminate or modify the license in the
event of a material breach, including if the Company does not meet
certain milestones by certain dates, or upon certain insolvency
events that remain uncured following the date that is 90 days
following written notice of such breach or insolvency event. The
Company may terminate the license, or any portion thereof, at its
sole discretion at any time upon 60 days written notice to the
NIH.
NRC
License
On
July 26, 2021, the Company entered into a non-exclusive Technology
License Agreement (the “NRC License Agreement”) with the National
Research Council of Canada (“NRC”) pursuant to which the NRC grants
to the Company a license to use NRC’s inventions, patents, trade
secrets, know-how, copyright, biological material, designs, and/or
technical information created by or on behalf of the NRC (the “NRC
Technologies”) relating to the derivatives of CHO 2353
TM Cell Line listed in the NRC License Agreement (the “Stable
Cells”) to: (i) make, research, and develop SARS-CoV-2 spike
protein manufactured by a Stable Cell (the “Drug Substance”)
within Canada, Australia, the United Kingdom, the European Union
and the United States (U.S.) (collectively the “Territory”); (ii)
file regulatory approval, export and sell the final formulation of
the Drug Substance (“Products”) and (iii) engage contractors to use
the Stable Cells to make Drug Substance or Products on behalf of
the Company to be used and sold, worldwide, by the Company. The NRC
License Agreement was subsequently amended to include the Delta and
Omicron variants. In addition, the Company subsequently amended the
NRC License Agreement to broaden the non-exclusive field of use to
include all diseases caused by coronaviruses and any genetic
variants thereof.
As
consideration for the grant of the license, the Company will pay to
the NRC an annual (low five digits) license fee, with the initial
portion of the fee covering the first three years of the license.
Additionally, we will pay certain milestone payments (a) upon
transfer of each Stable Cell listed in the Agreement and (b) with
regard to each of the first three Products, (i) upon submission of
the Investigational New Drug application (IND) related thereto,
(ii) upon dosing the first patient in a Phase 1 or Phase 2 clinical
trial, (iii) upon dosing the first patient in a Phase 3 clinical
trial and (iv) upon first regulatory approval. Milestone payments
range from the low five digits to high six digits. In addition,
Oragenics will pay a low single-digit royalty to the NRC for the
sale of Products, based on sales revenue, commencing after the
first commercial sale.
Pursuant
to the NRC License Agreement, the NRC is required to bear the
responsibility and pay the costs to obtain and maintain patents
related to the NRC Technologies in the U.S., Canada, Brazil,
European Union, Japan, South Korea, Singapore, Australia, China,
and India, and the NRC shall use reasonable efforts to obtain and
maintain those patents. Additional countries may be requested by
us, in which event, the NRC will file and maintain such patents, at
our expense.
Pursuant
to the NRC License Agreement, we are required to indemnify and hold
the NRC and its employees and agents harmless from and against all
liability and damages in connection with or arising out of all
claims, demands, losses, damages, costs including solicitor and
client costs, actions, suits or proceedings brought by any third
party that are in any manner based upon, arising out of, related
to, occasioned by, or attributable to the manufacturing,
distribution, shipment, offering for sale, sale, or use of
Products, services based on the NRC Technologies and product
liability and infringement of intellectual property rights other
than copyright, if any, licensed under the NRC License
Agreement.
Unless
terminated earlier, the NRC License Agreement will terminate twenty
(20) years from the effective date of the NRC License Agreement.
Either party may terminate the NRC License Agreement, by giving
written notice to the other party, if the other party defaults or
is in breach of the NRC License Agreement, provided that if the
defaulting party cures the breach within 60 days after the notice
is given, the NRC License Agreement shall continue in full force
and effect. The NRC may terminate the NRC License Agreement if the
Company becomes bankrupt, or insolvent, or has a receiver appointed
to continue its operations, or passes a resolution for winding up.
The NRC License Agreement contains customary confidentiality
obligations.
In
addition, in connection with the initiative to develop its vaccine,
we also previously entered into a material transfer agreement with
the NRC for SARS-CoV-2 trimeric spike protein Wuhan variant and
SARS-CoV-2 trimeric spike protein South African variant to move
forward with pre-clinical testing.
Leases
Lab
Facility-Alachua. The Company’s Alachua facility is being
leased from a real estate developer for a term of five years
beginning in December 2019. Under the amended lease agreement, the
rental payments range from $12,870 per month to $13,338 per month. The lease may be
terminated prior to its stated expiration date upon the payment of
nine-months rent.
Corporate
Office – Tampa. In November of 2016, the Company entered into
an amendment for the leased office space for corporate personnel
located in Tampa, FL. The amended lease is for approximately
2,207 square feet.
The lease period for the office space is
for thirty-six months commencing on March 1, 2017. Lease
payments range from $4,138 per month to $4,392 per month inclusive of
insurance, taxes and utilities. The lease expired on February 29, 2020. In November
of 2019, the Company entered into an amendment for
the Tampa facility for a term of three years beginning in March of
2020. Under the amended lease agreement, the rental payments
range from $4,524 per month to $4,800 per month.
Supplemental
balance sheet information related to leases is as
follows:
Schedule of Supplemental Balance Sheet
Information Related to Leases
|
|
June 30, 2022 |
|
|
December 31, 2021 |
|
Weighted Average Remaining Lease Term
In Years |
|
|
|
|
|
|
|
|
Operating leases |
|
|
1.95 |
|
|
|
2.45 |
|
|
|
|
|
|
|
|
|
|
Weighted Average Discount Rate |
|
|
|
|
|
|
|
|
Operating
leases |
|
|
5.69 |
% |
|
|
5.70 |
% |
Maturities
of operating lease liabilities are as follows:
Schedule of Maturities of Operating Lease
Liabilities
Year ended December 31: |
|
|
|
|
2022 |
|
$ |
108,829 |
|
2023 |
|
|
169,656 |
|
2024 |
|
|
146,718 |
|
Total |
|
$ |
425,203 |
|
Less:
Imputed interest |
|
|
(27,026 |
) |
Present value
of lease liabilities |
|
$ |
398,177 |
|
The
cost component of operating leases is as follows:
Schedule of Cost Component of Operating
Leases
|
|
For
the Six Months
Ended
June 30, 2022
|
|
|
For
the Six Months
Ended
June 30, 2021
|
|
Operating lease cost |
|
$ |
114,259 |
|
|
$ |
114,002 |
|
Short-term
lease cost |
|
|
1,965 |
|
|
|
782 |
|
Total lease
cost |
|
$ |
116,224 |
|
|
$ |
114,784 |
|
Supplemental
cash flow information related to operating leases is as
follows:
Schedule of Supplemental Cash Flow
Information Related to Operating Leases
|
|
For
the Six Months
Ended
June 30, 2022
|
|
|
For
the Six Months
Ended
June 30, 2021
|
|
Cash paid for amounts included in the
measurement of lease liabilities: |
|
|
|
|
|
|
|
|
Operating cash flows from operating leases |
|
$ |
117,350 |
|
|
$ |
113,454 |
|
8.
Shareholders’
Equity
Common
Stock
The Company’s Board of Directors and the Company’s shareholders, at
its reconvened 2020 Annual Meeting on February 25, 2022, approved
an amendment to our Amended and Restated Articles of Incorporation
to (i) increase the number of authorized shares of common stock
from 200,000,000 shares to
250,000,000
shares.
During the three and six months ended June 30, 2022, the Company
issued no shares of common stock.
During
the three months ended March 31, 2021, the Company issued an
aggregate of 23,871,338
shares of common stock comprised of (i) 21,398,765
shares of common stock issued in connection with sales under its
At-The-Market Program which generated gross proceeds of
approximately $27.8 million and
(ii) 2,472,573 shares of common
stock issued as the result of the exercise of certain outstanding
warrants which generated gross proceeds of approximately $2.3 million as a result
of the exercise of certain outstanding.
Preferred
Stock
Series
C Non-Voting, Non-Convertible, Preferred Stock Dividend and
Redemption
During
the three months ended March 31, 2021, the Company provided a
notice of redemption, to the holder of the Company’s Series C
Preferred Stock to redeem all outstanding Series C Preferred Stock
(which included the dividend of 26.697 shares paid on
January 28, 2021 and any accrued dividends due through the
redemption date of March 13, 2021). The Series C Preferred Stock
redemption amount of approximately $5.6 million was paid
on March 15, 2021 and all outstanding shares of Series C Preferred
Stock were cancelled.
ITEM 2. |
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS |
The
following information should be read in conjunction with the
Consolidated Financial Statements, including the notes thereto,
included elsewhere in this Form 10-Q as well as our Annual Report
on Form 10-K for the year ended December 31, 2021 filed on March
24, 2022.
As
used in this quarterly report the terms “we”, “us”, “our”,
“Oragenics” and the “Company” mean Oragenics, Inc. and its wholly
owned subsidiary Noachis Terra Inc., unless the context otherwise
requires.
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q includes “forward-looking” statements
within the meaning of Section 27A of the Securities Act of 1933, as
amended and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward-looking statements are not historical facts,
but are based on current expectations, estimates and projections
about our industry, our beliefs and our assumptions. These
forward-looking statements include statements about our strategies,
objectives and our future achievement. To the extent statements in
this Quarterly Report involve, without limitation, our expectations
for growth, estimates of future revenue, our sources and uses of
cash, our liquidity needs, our current or planned clinical trials
or research and development activities, product development
timelines, our future products, regulatory matters, expense,
profits, cash flow balance sheet items or any other guidance on
future periods, these statements are forward-looking statements.
These statements are often, but not always, made through the use of
word or phrases such as “believe,” “will,” “expect,” “anticipate,”
“estimate,” “intend,” “plan,” and “would. “These forward-looking
statements are not guarantees of future performance and concern
matters that could subsequently differ materially from those
described in the forward-looking statements. Actual events or
results may differ materially from those discussed in this
Quarterly Report on Form 10-Q. Except as may be required by
applicable law, we undertake no obligation to update any
forward-looking statements or to reflect events or circumstances
arising after the date of this Report. Important factors that could
cause actual results to differ materially from those in these
forward-looking statements are in the section entitled “Risk
Factors” in the most recent Annual Report on Form 10- K filed with
the Securities and Exchange Commission, and the other risks and
uncertainties described elsewhere in this report as well as other
risks identified from time to time in our filings with the
Securities and Exchange Commission, press releases and other
communications. In addition, the statements contained throughout
this Quarterly Report concerning future events or developments or
our future activities, including concerning, among other matters,
current or planned clinical trials, anticipated research and
development activities, anticipated dates for commencement of
clinical trials, anticipated completion dates of clinical trials,
anticipated meetings with the FDA or other regulatory authorities
concerning our product candidates, anticipated dates for
submissions to obtain required regulatory marketing approvals,
anticipated dates for commercial introduction of products, and
other statements concerning our future operations and activities,
are forward-looking statements that in each instance assume that we
are able to obtain sufficient funding in the near term and
thereafter to support such activities and continue our operations
and planned activities in a timely manner. There can be no
assurance that this will be the case. Also, such statements assume
that there are no significant unexpected developments or events
that delay or prevent such activities from occurring. Failure to
timely obtain sufficient funding, or unexpected developments or
events, could delay the occurrence of such events or prevent the
events described in any such statements from occurring.
Overview
We
are a development-stage company dedicated to fighting infectious
diseases including coronaviruses and multidrug-resistant organisms.
Our lead product (NT-CoV2-1) is an intranasal vaccine candidate to
prevent coronavirus disease 2019 (“COVID-19”) from the SARS-CoV-2
virus and variants thereof. The NT-CoV2-1 program leverages
coronavirus spike protein research licensed from the National
Institute of Health and the National Research Council of Canada
with a focus on reducing viral transmission and offering a more
patient-friendly intranasal administration. Our lantibiotics
program features a novel class of antibiotics against bacteria that
have developed resistance to commercial antibiotics.
Our
SARS-CoV-2 Vaccine Product Candidate - NT-CoV2-1
Following
our May 2020 acquisition of one hundred percent (100%) of the total
issued and outstanding common stock of Noachis Terra, Inc.
(“Noachis Terra”) we are focused on the development and
commercialization of a vaccine product candidate to provide
long-lasting immunity from SARS-CoV-2, which causes COVID-19.
Noachis Terra is a party to a worldwide, nonexclusive intellectual
property and biological materials license agreement with the
National Institute of Allergy and Infectious Diseases (“NIAID”), an
institute within the National Institutes of Health (“NIH”),
relating to certain research, patent applications and biological
materials involving pre-fusion stabilized coronavirus spike
proteins and their use in the development and commercialization of
a vaccine to provide specific, long lasting immunity from
SARS-CoV-2. Since the acquisition we have conducted testing in
animal models, including SARS-CoV-2 challenge studies in hamsters,
using specific formulations for intramuscular administration (our
Terra CoV-2 vaccine candidate) and intranasal administration (our
NT-CoV2-1 vaccine candidate), both based on the NIAID pre-fusion
stabilized spike protein antigens. Following consideration of a
number of factors, including but not limited to the competitive
landscape, we determined to bring the intranasal vaccine candidate
NT-CoV2-1, into further development due to the greater
differentiation versus current COVID-19 vaccines and the potential
benefits of intranasal over intramuscular administration. We
believe these benefits could include a higher reduction of
transmission of SARS-CoV-2 and would offer a needle-free delivery
option. We therefore are currently focusing our development efforts
on our more highly differentiated NT-CoV2-1 vaccine
candidate.
On
July 26, 2021, we entered into a licensing agreement with the
National Research Council (“NRC”) that enables us to pursue the
development of next-generation vaccines against the SARS-CoV-2
virus and its variants. The license was subsequently amended to
include the Omicron variant to broadened the non-exclusive field of
use to include all diseases caused by coronaviruses and any genetic
variants thereof and to add a research protocol developed by the
NRC and reagents as part of the NRC Technology licensed by us. The
NRC technologies, in combination with the licensed technologies
from the U.S. NIH used in our NT-CoV2-1 vaccine candidate, provide
us with a platform that can generate cell lines for high-yield
production of spike protein antigens for existing and emerging
variants of concern. This platform should allow production of cell
lines within six to eight weeks of spike gene sequence
availability, compared with six to nine months for traditional
production of such cell lines. The NRC technologies, developed with
support from the NRC’s Pandemic Response Challenge Program, are
expected to enable expedited evaluation of SARS-CoV-2 antigen
candidates in pre-clinical and clinical studies.
Coronaviruses
are a family of viruses that can lead to upper-respiratory
infections in humans. Recent clinical reports also suggest that the
SARS-CoV-2 virus can affect other body-systems, including the
nervous, cardiovascular, gastrointestinal and renal systems. Among
the recent iterations of coronaviruses to move from animal to human
carriers is SARS-CoV-2, which, beginning in Wuhan, China, in late
2019, caused a global pandemic due to its rapid spread and the
relatively high mortality rate (as compared to the seasonal
influenza). In late July of 2022, the World Health Organization’s
estimates indicate the number of worldwide COVID-19 infections have
exceeded 566 million and the number of deaths directly attributed
to COVID-19 have exceeded 6.4 million. Pfizer/BioNTech received FDA
approval for their COVID-19 vaccines in August of 2021 and the
Moderna vaccine in January 2022. The Janssen vaccine is currently
available in the United States under Emergency Use Authorizations
(“EUA”) by the FDA. In July 2022, the FDA granted EUA for the
Novavax COVID-19 vaccine as well. The overall disease burden from
COVID-19 has continued to increase in the U.S. despite 92% of those
age 65 or older being fully vaccinated and 72% of those age 5 or
older. Current vaccines have reduced the rates of hospitalization
and death due to COVID-19 in vaccinated individuals, but the
transmission levels even in vaccinated individuals has allowed
SARS-CoV-2 variants to continue to circulate. We believe given the
size of the worldwide pandemic that even with additional vaccines
available in the months ahead, there will be demand for the highly
differentiated NT-CoV2-1 vaccine, once development is successfully
completed. We intend to combine the research, patent applications
and biological materials covered by our NIAID license and with our
NRC license and our existing clinical research and manufacturing
capabilities to respond rapidly to this ongoing, global, public
health issue. We believe our NT-CoV2-1 vaccine holds the
possibility of playing an important role in addressing this
issue.
Coronaviruses, such as SARS-CoV-2, possess signature protein spikes
on their outer capsule. Our NIAID license covers patents and data
on a vaccine candidate that were created based on a stabilized
pre-fusion spike trimeric protein. By stabilizing the spike protein
in the pre-fusion state, the number of immunogenic centers is
increased thereby allowing for a greater likelihood of successful
antibody binding, resulting in an improved immunogenic response.
Spike protein antigens stabilized in the pre-fusion state have been
used successfully in the leading COVID-19 vaccines from
Pfizer/BioNTech and Moderna, which we believe reduces the risk of
using the same approach in our NT-CoV2-1 vaccine candidate. The
Company is currently producing Phase 1 clinical materials based on
the pre-fusion protein stabilization technology licensed from the
NIH as well as additional antigen design technologies licensed from
the NRC.
We
entered into both a material transfer agreement and a non-exclusive
research license agreement with Inspirevax for the use of
intranasal mucosal adjuvants in our NT-CoV2-1 vaccine candidates.
Regarding the intranasal mucosal adjuvants of interest, BDX300 and
BDX301 are proteosome-based adjuvants comprised of proteins and
lipopolysaccharides with improved attributes including enhanced
immune response, manufacturing efficiency and the benefits of
intranasal vaccine administration. The non-exclusive license
agreement allows for the collaboration and research regarding the
intranasal delivery of vaccine during clinical development with the
opportunity to enter into a commercial agreement upon regulatory
approval of the intranasal vaccine. The NT-CoV2-1 vaccine
containing Inspirevax’s intranasal mucosal adjuvant BDX301 has been
studied in pre-clinical animal studies, including hamster viral
challenge studies and mouse immunogenicity studies. A rabbit
toxicology study has been initiated and is required for regulatory
approval prior to the Phase 1 clinical study.
We
began pre-clinical studies in June of 2021 through our
collaboration and material transfer agreement with the NRC. We
initiated an immunogenicity study in mice to evaluate several
adjuvant candidates. On August 30, 2021, we announced the
successful completion of these mouse immunogenicity studies that
supported further development using either the intramuscular or
intranasal routes of administration. A hamster challenge study was
initiated in September of 2021 to assess inhibition of viral
replication using adjuvants specific for intramuscular and
intranasal administration. In December of 2021, we announced that
both formulations generated robust immune responses and reduced the
SARS-CoV-2 viral loads to undetectable levels in the nasal passages
and lungs five days following a viral challenge. By contrast,
hamsters in the control groups that had received saline or
adjuvants alone had no detectable immune response and substantial
viral loads. The vaccines delivered by intranasal and intramuscular
routes generated immune responses as measured by multiple assays.
On June 14, 2022, we announced that the results of these studies
were published in Nature Scientific Reports.
In
March of 2022, following a positive assessment of a rabbit-based
pilot study, we initiated a Good Laboratory Practice toxicology
study to evaluate the safety profile and immunogenicity of
NT-CoV2-1 in rabbits. This important preclinical study is designed
to provide data required to advance our intranasal vaccine
candidate into human clinical studies. While the study has
concluded, we are completing the full set of toxicology data which
will be needed to support the filing of an IND application for
NT-CoV2-1. Based on our previous preclinical results, we are
encouraged that this study may further support our intranasal
development path.
While
we previously had a Type B Pre-IND Meeting with the FDA on our
intramuscular vaccine product candidate, we again met with the FDA
in a Type B Pre-IND Meeting request to discuss our intranasal
vaccine product candidate. As a result of this meeting, the FDA
indicated that the Company could file an IND application for
NT-CoV2-1 following the availability of the final GLP toxicology
report for inclusion in the IND.
We
believe the benefits of our NT-CoV2-1 vaccine product candidate
through its intranasal delivery mechanism to be:
|
● |
Targeted
Mucosal Immunity – Conventional injectable vaccines are poor
inducers of mucosal immunity, whereas intranasal immunization can
induce strong mucosal immunity by enhancing the immune response at
the entry sites of mucosal pathogens. When the SARS-CoV-2 virus
enters the nasal cavity, the respiratory epithelial layer is the
first barrier against viral infection. The intranasal route of
vaccination provides two additional layers of protection over
intramuscular shots because (i) it produces immunoglobulin A and
resident memory B and T cells in the respiratory mucosa that are an
effective barrier to infection at those sites, and (ii)
cross-reactive resident memory B and T cells can respond earlier
than other immune cells should a viral variant start an
infection. |
|
|
|
|
● |
Needle-Free
Administration – As an obvious benefit, intranasal
administration means needle-free delivery, resulting in meaningful
differentiation for children and needle-phobic populations,
improved compliance and the potential for
self-administration. |
|
|
|
|
● |
Storage
& Transport – The currently available mRNA-based vaccines
have been delivered globally via stringent storage and transport
requirements that strain distribution logistics under the best of
circumstances. A key benefit of our NT-CoV2-1 vaccine candidate is
a significantly reduced handling burden, allowing transport at a
more manageable refrigeration temperature (5°C) that improves
access globally including remote and under-vaccinated
geographies. |
|
|
|
|
● |
Durability
– Broad initial success with mRNA vaccines has significantly
diminished COVID-19’s impact and death, but the trade-off has been
fleeting efficacy. By benefitting from the immunological properties
of the hybrid NIH/NRC construct, NT-CoV2-1 is potentially much more
durable and long-lasting than currently available mRNA-based
therapies. |
Through
assessment of a variety of factors including our pre-clinical
testing to date, the expected benefits noted above, evolving
variants and available vaccines in use, we determined to focus our
development efforts on the intranasal delivery of our vaccine
product candidate, NT-CoV2-1, which we believe is more highly
differentiated than the currently available and late-stage COVID-19
vaccines. We expect to file an IND application with the FDA upon
completion of our pending toxicology study and to thereafter
commence a Phase 1 clinical study with NT-CoV2-1, the protocol for
which is currently under development.
In
parallel with our pursuit of an IND for a US-based Phase 1 study,
we are exploring regulatory approval of an equivalent safety and
immunogenicity study with Health Canada through the submission of a
Clinical Trial Application (“CTA”) with feedback expected by the
end of 2022. Given Health Canada’s experience with related
adjuvants to that used in NT-CoV2-1 and the growing urgency for
nasal vaccines, we believe this parallel regulatory path remains a
viable route for maintaining our development timelines.
We
expect to use our currently available cash resources to continue to
advance the development of NT-CoV2-1 through IND-enabling studies
and commencement of a Phase 1 clinical trial with further clinical
development being contingent upon the receipt of additional
funding, including non-dilutive government grant funding which we
continue to pursue, or partnering or out-licensing
opportunities.
Our
Antibiotic Product Candidate - Oragenics Derived Compound
(ODC-x)
Members
of our scientific team discovered that a certain bacterial strain
of Streptococcus mutans, produces Mutacin 1140 (MU1140), a
molecule belonging to the novel class of antibiotics known as
lantibiotics. Lantibiotics, such as MU1140, are highly modified
peptide antibiotics made by a small group of Gram-positive
bacterial species. Over 60 lantibiotics have been discovered, to
date. We believe lantibiotics are generally recognized by the
scientific community to be potent antibiotic agents.
In
nonclinical testing, MU1140 has shown activity against all
Gram-positive bacteria against which it has been tested, including
those responsible for a number of healthcare associated infections,
or HAIs. A high percentage of hospital-acquired infections are
caused by highly antibiotic-resistant bacteria such as
methicillin-resistant Staphylococcus aureus (MRSA) or
multidrug-resistant Gram-negative bacteria. We believe the need for
novel antibiotics is increasing as a result of the growing
resistance of target pathogens to existing FDA approved antibiotics
on the market.
Lantibiotics
have been difficult to investigate for their clinical usefulness as
therapeutic agents in the treatment of infectious diseases due to a
general inability to produce or synthesize sufficient quantities of
pure amounts of these molecules. Traditional fermentation methods
can only produce minute amounts of the lantibiotic.
The
timing of the filing of an IND regarding any future lantibiotic
candidate is subject to our having sufficient available human,
material and financing capital, which includes research subjects,
both animal and human, given all of our anticipated needs and
expected requirements in connection with our ongoing research and
development initiatives. We expect to continue to advance our
lantibiotics program to an IND filing based on the availability of
both human and financial capital. Based upon the current funding we
expect to continue to focus on the identification of new potential
product lantibiotic candidates, efficient and cost-effective
improvements in the manufacturing processes and pre-clinical
studies required to support a first in human Phase 1 clinical
study.
In
October 2021, we were awarded a small business innovation research
grant in the amount of $250,000 (“Computer-aided Design for
Improved Lantibiotics”, R41GM136034) for the Company’s continued
research and development of lantibiotics, including its
collaborative program with the Biomolecular Sciences Institute at
Florida International University (FIU). The grant provides the
Company with funding to develop novel lantibiotics for the
treatment of ESKAPE pathogens (defined as Enterococcus faecium,
Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter
baumannii, Pseudomonas aeruginosa, and Enterobacter
spp.).
Product
Candidates.
Through
our wholly-owned subsidiary, Noachis Terra, we began the research
and development stage for our new Terra CoV-2 and NT-CoV2-1 vaccine
product candidates. We hold a nonexclusive, worldwide intellectual
property license agreement for certain research, patent
applications and biological materials relating to the use of
pre-fusion coronavirus spike proteins for the development and
commercialization of a vaccine against SARS-CoV-2. We also hold a
non-exclusive license with the NRC that enables us to pursue the
rapid development of next-generation vaccines against the
SARS-CoV-2 (the “NIH License”) virus and its variants (the “NRC
License” and together with the NIH License the License
Agreements.
Additionally,
we are developing semi-synthetic lantibiotic analogs that may be
effective against systemic Gram-positive multidrug infections, and
analogs that may be effective in treating Gram-negative infections.
We seek to protect our product candidates through patents and
patent applications pursuant to the terms of our license
agreements.
Product/Candidate |
|
Description |
|
Application |
|
Status |
|
|
|
|
|
|
|
NT-CoV2-1 |
|
Intranasal
vaccine candidate (recombinant protein + adjuvant) to provide long
lasting immunity against SARS-CoV-2 |
|
Broad,
community-based vaccine immunity against SARS-CoV-2 |
|
Pre-clinical |
|
|
|
|
|
|
|
Antibiotics |
|
Semi-synthetic
analogs of MU1140: Member of lantibiotic class of
antibiotics |
|
Healthcare-associated
infections |
|
Pre-clinical |
Our Business Development Strategy
Success in the biopharmaceutical and product development industry
relies on the continuous development of novel product candidates.
Most product candidates do not make it past the clinical
development stage, which forces companies to look externally for
innovation. Accordingly,
we expect from time to time, to seek strategic opportunities
through various forms of business development, which can include
strategic alliances, licensing deals, joint ventures,
collaborations, equity-or debt-based investments, dispositions,
mergers and acquisitions. We view these business development
activities as a necessary component of our strategies, and we seek
to enhance shareholder value by evaluating business development
opportunities both within and complementary to our current business
as well as opportunities that may be new and separate from the
development of our existing product candidates.
Financial
Overview
Impact of the Novel Coronavirus.
The
current COVID-19 pandemic has presented a substantial public health
and economic challenge around the world and is affecting our
employees, development partners, communities and business
operations, as the U.S. and global economies and financial markets.
The full extent to which the COVID-19 pandemic will directly or
indirectly impact our business, results of operations and financial
condition will depend on future developments that are highly
uncertain and cannot be accurately predicted, including new
information or trends that may emerge concerning COVID-19, the
actions taken to contain it or treat its impact, the emergence of
any new variant strains of COVID-19, and the impact on local,
regional, national and international markets.
To
date, we and our development partners, have been able to conduct
ordinary operations at or near normal levels and do not currently
anticipate any interruptions for the foreseeable future. However,
there could be additional repercussions for our operations,
particularly for the initial development of our NT-CoV2-1 product
candidate, including but not limited to, the sourcing of materials
for product candidates, manufacture of supplies for preclinical
and/or clinical studies, delays in clinical operations, which may
include the availability or the continued availability of patients
for trials due to such things as quarantines, conduct of patient
monitoring and clinical trial data retrieval at investigational
study sites. The continuation of the pandemic could adversely
affect our planned clinical trial operations, including our ability
to conduct the trials on the expected timelines and recruit and
retain patients and principal investigators and site staff who, as
healthcare providers, may have heightened exposure to COVID-19 if
their geography is impacted by the pandemic. Further, the COVID-19
pandemic could result in delays in our clinical trials due to
prioritization of hospital resources toward the pandemic, the broad
emergency use authorization of vaccines, restrictions in travel,
potential unwillingness of patients to enroll in trials at this
time, or the inability of patients to comply with clinical trial
protocols if quarantines or travel restrictions impede patient
movement or interrupt healthcare services. In addition, we rely on
independent clinical investigators, contract research organizations
and other third-party service providers to assist us in managing,
monitoring and otherwise carrying out our preclinical studies and
clinical trials, and the pandemic may affect their ability to
devote sufficient time and resources to our programs or to travel
to sites to perform work for us.
Research and Development Expenses
Research
and development consist of expenses incurred in connection with the
discovery and development of our product candidates. These expenses
consist primarily of employee-related expenses, which include
salaries and benefits and attending science conferences; expenses
incurred under our License Agreements with third parties and under
other agreements with contract research organizations,
investigative sites and consultants that conduct our clinical
trials and a substantial portion of our nonclinical studies; the
cost of acquiring and manufacturing clinical trial materials;
facilities, depreciation and other allocated expenses, which
include direct and allocated expenses for rent and maintenance of
facilities and equipment, and depreciation of fixed assets; license
fees, for and milestone payments related to, in-licensed products
and technology; stock-based compensation expense; and costs
associated with nonclinical activities and regulatory approvals. We
expense research and development costs as incurred.
Our
research and development expenses can be divided into (i) clinical
research, and (ii) nonclinical research and development activities.
Clinical research costs consist of clinical trials, manufacturing
services, regulatory activities all of which are largely provided
by third parties. Nonclinical research and development costs
consist of our research activities, research activities provided by
third parties, our own nonclinical studies, nonclinical studies
provided by third parties, the acquisition of in process research
and development, related personnel costs and laboratory supplies,
and other costs such as rent, utilities, depreciation and
stock-based compensation and research expenses we incur associated
with the development of our product candidates. While we are
currently focused on advancing our product development programs,
our future research and development expenses will depend on the
clinical success of our product candidates, as well as ongoing
assessments of each product candidate’s commercial potential. In
addition, we cannot forecast with any degree of certainty which
product candidates may be subject to future collaborations, when
such arrangements will be secured, if at all, and to what degree
such arrangements would affect our development plans, research
expenses and capital requirements.
Our
research and development expenses were $7,771,244 and $5,728,479
for the six months ended June 30, 2022 and 2021,
respectively.
Our
current product development strategy contemplates an expected
increase in our research and development expenses in the future as
we continue the advancement of our product development programs for
our vaccine and lantibiotic product candidates, with greater
near-term emphasis on our vaccine product candidate. The lengthy
process of completing pre-clinical studies, clinical trials;
seeking regulatory approval for our product candidates; and
expanding the potential claims we are able to make, requires
expenditure of substantial resources. Any failure or delay in
completing pre-clinical studies, clinical trials, or in obtaining
regulatory approvals, could cause a delay in generating product
revenues and cause our research and development expenses to
increase and, in turn, have a material adverse effect on our
operations. Our current product candidates are not expected to be
commercially available until we are able to obtain regulatory
approval from the FDA or the regulatory authority in other
jurisdictions where we may seek approval.
Our
plan is to budget and manage expenditures in research and
development such that they are undertaken in a cost-effective
manner yet still advance the research and development efforts.
While we have some control under our Lantibiotic program and the
License Agreements as to the planning and timing of our research
and development and therefore the timing of when expenditures may
be incurred for various phases of agreed upon projects, actual
expenditures can vary from period to period. Subject to available
capital, we expect overall research and development expenses to
increase as a result of our vaccine product candidate and to remain
relatively constant with respect to our lantibiotic program. Our
research and development projects are currently expected to be
taken to the point where they can be licensed or partnered with
larger pharmaceutical companies.
General and Administrative Expenses
General
and administrative expenses consist principally of salaries and
related costs for personnel in executive, finance, and
administrative functions. Other general and administrative expenses
include facility costs not otherwise included in research and
development expenses, patent filing, and professional fees for
legal, consulting, auditing and tax services.
We
anticipate that our general and administrative expenses to increase
for, among others, the following reasons:
|
● |
to
support our research and development activities, which, subject to
available capital, we expect to expand as we continue the
development of our product candidates; |
|
|
|
|
● |
the
efforts we undertake from, time to time, to raise additional
capital; and |
|
|
|
|
● |
the
increased payroll, and stock-based compensation, expanded
infrastructure and higher consulting, legal, accounting and
investor relations costs associated with being a public
company. |
Other Income (Expense)
Other
income (expense) includes local business taxes, gain on sale of
property and equipment, as well as interest income and expense.
Interest income consists of interest earned on our cash and cash
equivalents, and interest earned on the stock subscription
receivable. The primary objective of our investment policy is
capital preservation. Interest expense consists primarily of
interest and costs associated with our indebtedness.
Income Taxes
At
December 31, 2021, the Company has federal and state tax net
operating loss carryforwards of $145,260,353. Federal and state tax
net operating loss carryforwards generated prior to December 31,
2017 will expire through 2037 and are not subject to taxable income
limitations. Federal tax net operating loss carryforwards generated
subsequent to December 31, 2017, do not expire but are subject to
taxable income limitation pursuant to the Tax Cuts and Jobs Act
that was enacted on December 22, 2017. State of Pennsylvania tax
net operating loss carryforwards will expire through 2036. The
Company also has federal research and development tax credit
carryforwards of $4,027,180. The federal tax credit carryforward
will expire beginning in 2021 and continuing through 2041 unless
previously utilized.
Utilization
of net operating loss carryforwards and research and development
credit carryforwards may be subject to a substantial annual
limitation due to ownership change limitations that may have
occurred or, could occur in the future in accordance with Section
382 of the Internal Revenue Code of 1986 (“IRC Section 382”) and
with Section 383 of the Internal Revenue Code of 1986, as well as
similar state provisions. These ownership changes may limit the
amount of net operating loss carryforwards and research and
development credit carryforwards that can be utilized annually to
offset future taxable income and taxes, respectively. In general,
an ownership change, as defined by IRC Section 382, results from
transactions increasing the ownership of certain stockholders or
public groups in the stock of a corporation by more than 50
percentage points over a three-year period. The Company has
completed several financings since its inception, as well as the
recent acquisition of Noachis Terra, which may result in a change
in ownership as defined by IRC Section 382, or could result in a
change in control in the future. In each period since our
inception, we have recorded a 100% valuation allowance for the full
amount of our deferred tax asset, as the realization of the
deferred tax asset is uncertain. As a result, we have not recorded
any federal tax benefit in our statements of operations.
Results
of Operations for the Three Months Ended June 30, 2022 and
2021
Grant revenue. Grant
revenue was $30,391 for the three months ended June 30, 2022
compared to $-0- for the three months ended June 30, 2021; an
increase of $30,391, or 100.0%. This increase was attributable to
the award of a small business innovation research grant.
Research and Development. Research and development expenses
were $3,033,182 for the three months ended June 30, 2022 compared
to $2,467,575 for the three months ended June 30, 2021, an increase
of $565,607 or 22.9%.
The table below provides a breakdown of our research and
development expense for the periods for our current development
programs:
|
|
For the Three Months Ended June 30, 2022 |
|
|
For the Three Months Ended June 30, 2021 |
|
Lantibiotics
Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical Research |
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Non-clinical research and
development activities |
|
|
297,520 |
|
|
|
304,311 |
|
|
|
|
|
|
|
|
|
|
Vaccine Development
Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical Research |
|
|
864,367 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Non-clinical
research and development activities |
|
|
1,871,295 |
|
|
|
2,163,264 |
|
|
|
|
|
|
|
|
|
|
Total
Research and Development expense |
|
$ |
3,033,182 |
|
|
$ |
2,467,575 |
|
This
increase was primarily due to increases in costs associated with
the NT-CoV2-1 vaccine program, supplies and equipment costs, and
rent and utilities costs of $572,398, $34,292, and $18,735,
respectively. These increases were partially offset by decreases in
costs associated with salaries and costs associated with our
lantibiotic program of $29,967, and $23,254, respectively. The
increase in research and development expenses attributable to the
vaccine development program related to our taking the requisite
preclinical steps to be in a position to submit an Initial New Drug
Application to the FDA or other regulatory agency, including
conducting toxicology studies in mice, hamsters, and rabbits,
enablement of COVID 19 variants, securing an adjuvant, assay
testing, stability and release testing and preparing the elements
necessary for manufacturing of our vaccine product candidate in
order to be in a position to move forward with a Phase 1 and Phase
2 clinical studies.
General and Administrative. General and administrative
expenses were $1,044,334 for the three months ended June 30, 2022
compared to $1,370,393 for three months ended June 30, 2021, a
decrease of $326,059 or 23.8%. This decrease was primarily due to
decreases in salaries, filing fees and registration costs, and
board costs of $252,448, $134,054, and $33,687. These decreases
were offset by increases in non-employee stock-based compensation,
and insurance costs of $54,704 and $37,431,
respectively.
Other Income. Other income, net was $14,432 for the three
months ended June 30, 2022 compared to $22,621 for the three months
ended June 30, 2021, resulting in a net change of $8,189. The net
change was primarily attributable to a decrease in interest income
of $8,885.
Results
of Operations for the Six Months Ended June 30, 2022 and
2021
Grant revenue. Grant
revenue was $45,474 for the six months ended June 30, 2022 compared
to $-0- for the six months ended June 30, 2021; an increase of
$45,474, or 100.0%. This increase was attributable to the award of
a small business innovation research grant.
Research and Development. Research and development expenses
were 7,771,244 for the six months ended June 30, 2022 compared to
5,728,479 for the six months ended June 30, 2021, an increase of
$2,042,765 or 35.7%.
The table below provides a breakdown of our research and
development expense for the periods for our current development
programs:
|
|
For the Six Months Ended June 30, 2022 |
|
|
For the Six Months Ended June 30, 2021 |
|
Lantibiotics
Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical Research |
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Non-clinical research and
development activities |
|
|
688,557 |
|
|
|
595,383 |
|
|
|
|
|
|
|
|
|
|
Vaccine Development
Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical Research |
|
|
1,955,117 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Non-clinical
research and development activities |
|
|
5,127,570 |
|
|
|
5,133,096 |
|
|
|
|
|
|
|
|
|
|
Total
Research and Development expense |
|
$ |
7,771,244 |
|
|
$ |
5,728,479 |
|
This
increase was primarily due to increases in costs associated with
the NT-CoV2-1 vaccine program, supplies and equipment costs, bonus
costs, costs associated with our lantibiotic ECC, patent costs, and
rent and utilities costs, of $2,491,852, $44,490, $39,060, $27,966,
$26,745, and $18,891, respectively. These increases were partially
offset by decreases in costs associated with consideration relating
to the acquisition of Noachis Terra, Inc., and salaries of
$542,261, and $71,603, respectively. The increase in research and
development expenses attributable to the vaccine development
program related to our taking the requisite preclinical steps to be
in a position to submit an Initial New Drug Application to the FDA
or other regulatory agency, including conducting toxicology studies
in mice, hamsters, and rabbits, enablement of COVID 19 variants,
securing an adjuvant, assay testing, stability and release testing
and preparing the elements necessary for manufacturing of our
vaccine product candidate in order to be in a position to move
forward with a Phase 1 and Phase 2 clinical studies.
General and Administrative. General and administrative
expenses were $2,375,883 for the six months ended June 30, 2022
compared to $3,346,969 for six months ended June 30, 2021, a
decrease of $971,086 or 29.0%. This decrease was primarily due to
decreases in non-employee stock-based compensation, salaries,
employee benefits, stock-based compensation costs, and payroll
taxes of $945,141, $336,103, $27,233, $26,692, and $21,091. These
decreases were offset by increases in costs associated with filing
fees and registration costs, insurance, bonus, and legal costs of
$216,742, $75,572, and $52,254, respectively.
Other Income. Other income, net was $33,566 for the six
months ended June 30, 2022 compared to $40,156 for the six months
ended June 30, 2021, resulting in a net change of $6,590. The net
change was primarily attributable to a decrease in interest income
of $16,273. and an increase in the gain on sale of property and
equipment of $10,964.
Liquidity
and Capital Resources
Since
our inception, we have funded our operations primarily through the
sale of equity securities in our initial public offering, the sale
of equity securities and warrants in private placements, debt
financing, warrant exercises, public offerings, and grants. During
the six months ended June 30, 2022 and June 30, 2021 our operating
activities used cash of $9,019,757, and $6,405,775, respectively.
The use of cash in all periods primarily resulted from our net
losses adjusted for non-cash items and changes in operating assets
and liabilities. We had a working capital surplus of $16,509,559
and $26,262,129 at June 30, 2022 and December 31, 2021,
respectively.
During
the six months ended June 30, 2022 and June 30, 2021, our investing
activities used cash of $(75,047) and $-0- respectively. The cash
used by investing activities during the six months ended June 30,
2022, was primarily due to the purchase of property and equipment
net of the proceeds from the sale of property and
equipment.
During
the six months ended June 30, 2022 and June 30, 2021, our financing
activities used and provided cash of $(303,416) and $23,340,969
respectively. The cash used by and provided in financing activities
during the six months ended June 30, 2022 and June 30, 2021, was
primarily due to payments on short term notes payable, the sales of
common stock, the exercise of warrants, and the redemption of the
Series C Preferred stock.
Financing
Additional
details of our financing activities for the periods reflected in
this report are provided below as well as certain information on
our outstanding shares of preferred stock:
November 2020 Public Offering.
On
November 24, 2020, we closed an underwritten public offering for
gross proceeds of approximately $6.0 million, which included the
full exercise of the underwriter’s over-allotment option to
purchase additional shares, prior to deducting underwriting
discounts and commissions and offering expenses. The offering was
comprised of 14,189,189 shares of common stock at a price to the
public of $0.37 per share. We granted the underwriter a 45-day
option to purchase up to 2,128,378 additional shares of our common
stock at the public offering price, less underwriting discounts and
commissions. The underwriter exercised its option in full to
purchase 2,128,378 additional shares of common stock, which the
indicated gross proceeds reflect. We intend to use the net proceeds
of the offering primarily to continue funding our pre-clinical
development of our SARS-CoV-2 vaccine, NT-CoV2-1 and our
lantibiotics program and for general corporate purposes, including
research and development activities, capital expenditures and
working capital. Dr. Frederick Telling who is a Director of the
Company, participated in the offering through the purchase of
100,000 shares of the Company’s common stock. Dr. Telling’s
participation was approved by the Company’s Audit
Committee.
December 2020 Registered Direct Offering.
On
December 29, 2020, we closed a registered direct offering for gross
proceeds of approximately $6.5 million, prior to deducting
underwriting discounts and commissions and offering expenses. The
offering was comprised of 14,444,444 shares of common stock at a
price to the public of $0.45 per share. We intend to use the net
proceeds of the offering primarily to continue funding our
pre-clinical development of our SARS-CoV-2 vaccine, NT-CoV2-1 and
our lantibiotics program and for general corporate purposes,
including research and development activities, capital expenditures
and working capital.
At-the- Market (“ATM Program”)
On
February 1, 2021, we entered into a Sales Agreement (the “Sales
Agreement”) with A.G.P./Alliance Global Partners, as sales agent
(the “Sales Agent”), pursuant to which we may offer and sell
through or to the Sales Agent shares of our Common Stock (the “ATM
Program”). During the three months ended March 31, 2021, we issued
an aggregate of 21,398,765 shares of Common Stock and received
gross proceeds of an aggregate of approximately $27.8 million under
our ATM Program. Any Shares offered and sold in the ATM Program
were issued pursuant to our universal shelf registration statement
on Form S-3 (the “Shelf Registration Statement”) of which
$9,671,869 remains available under our Shelf Registration
Statement. The ATM Program will terminate upon (a) the election of
the Agent upon the occurrence of certain adverse events, (b) 10
days’ advance notice from one party to the other, or (c) the sale
of the balance available under our Shelf Registration Statement.
Under the terms of the Sales Agreement, the Sales Agent is entitled
to a commission at a fixed rate of 3.0% of the gross proceeds from
each sale of shares under the Sales Agreement.
Other Financings
We
enter into short term financing arrangements for the payment of our
annual insurance premiums for our products liability insurance and
directors and officers and employment practices
insurance.
Products
Liability Insurance
The
product liability insurance policy has been renewed in subsequent
periods without premium financing.
Directors’
and Officers’ Insurance
On
July 24, 2021, we entered into a short-term note payable for
$600,169 bearing interest at 5.34% to finance a portion of the
directors’ and officers’ liability insurance and employment
practices liability insurance premiums. Principal and interest
payments on this note began August 24, 2021 and are made evenly
based on a straight-line amortization over a 10-month period with
the final payment being made on May 16, 2022.
On
July 24, 2020, we entered into a short-term note payable for
$413,784 bearing interest at 5.39% to finance a portion of the
directors’ and officers’ liability insurance and employment
practices liability insurance premiums. Principal and interest
payments on this note began August 24, 2020 and were made evenly
based on a straight-line amortization over an 11-month period with
the final payment being made on June 28, 2021.
Our Outstanding Preferred Stock
During
2017, we issued shares of Series A and Series B Preferred Stock in
financing transactions (the “Preferred Stock Financings”). In
connection with the Preferred Stock Financings, we filed
Certificate of Designations of Preferences, Rights and Limitations
of Series A and Series B Preferred Stock with the Secretary of
State of the State of Florida, effective May 10, 2017 and November
8, 2017, respectively. Our currently outstanding Series A and
Series B Preferred Stock and the amount of common stock that may be
issued upon conversion is set forth below:
Preferred Stock Series |
|
Outstanding
Shares
|
|
|
Common Stock Equivalents |
|
Series A Preferred |
|
|
9,417,000 |
|
|
|
941,701 |
|
Series B Preferred |
|
|
6,600,000 |
|
|
|
1,320,002 |
|
In
addition, we issued warrants to purchase an aggregate of (i)
1,064,520 shares of Common Stock to the Series A holders, and (ii)
1,064,518 shares of Common Stock to the Series B holders in
connection with the Preferred Stock Financings.
Except
as otherwise required by law, the Series A and Series B Preferred
Stock have no voting rights. However, as long as any shares of
Series A and Series B Preferred Stock are outstanding, we shall
not, without the affirmative vote of the holders of a majority of
the then outstanding shares of the Series A and Series B Preferred
Stock, (a) alter or change adversely the powers, preferences or
rights given to the Series A or Series B Preferred Stock or alter
or amend the Certificate of Designation, (b) amend its articles of
incorporation or other charter documents in any manner that
adversely affects any rights of the holders of Series A and Series
B Preferred Stock, (c) increase the number of authorized shares of
Series A and Series B Preferred Stock, or (d) enter into any
agreement with respect to any of the foregoing. Upon any
liquidation, dissolution or winding-up by us, whether voluntary or
involuntary that is not a Fundamental Transaction (as defined in
the Certificate of Designations), the holders of Series A and
Series B Preferred Stock shall be entitled to receive out of the
assets, the greater of (i) the product of the number of shares of
Series A and Series B Preferred Stock then held by such holder,
multiplied by the Original Issue Price; and (ii) the amount that
would be payable to such holder in the Liquidation (as defined in
the Certificate of Designations) in respect of Common Stock
issuable upon conversion of such shares of Series A and Series B
Preferred Stock if all outstanding shares of Series A and Series B
Preferred Stock were converted into Common Stock immediately prior
to the Liquidation. The Series A and Series B Preferred Stock is
classified as permanent equity. Each of the Series A and Series B
Preferred Stock have redemption rights to the extent we have funds
legally available therefor, at any time after the fifth anniversary
of the original issue date of the applicable Series A and Series B
Preferred Stock. We have the right to redeem all or any portion of
the outstanding shares of Series A and Series B Preferred Stock at
the original issue price by providing at least seventy five (75)
days written notice of such redemption to all holders of the then
outstanding shares of Series A and Series B Convertible Preferred
Stock.
Future
Capital Requirements
Our
capital requirements for 2022 will depend on numerous factors,
including the success of our commercialization efforts and of our
research and development, the resources we devote to develop and
support our technologies and our success in pursuing strategic
licensing and funded product development relationships with
external partners. Subject to our ability to raise additional
capital including through possible joint ventures and/or
partnerships, we expect to incur substantial expenditures to
further commercialize or develop our technologies including
continued increases in costs related to research, nonclinical
testing and clinical trials, as well as costs associated with our
capital raising efforts and being a public company. We will require
substantial funds to conduct research and development and
nonclinical and Phase 1 and Phase 2 clinical testing of our
licensed, patented technologies and to develop sublicensing
relationships for the Phase 2 and 3 clinical testing and
manufacture and marketing of any products that are approved for
commercial sale. Our plans include seeking both equity and debt
financing, alliances or other partnership agreements with entities
interested in our technologies, or other business transactions that
would generate sufficient resources to ensure continuation of our
operations and research and development programs.
Our
current available cash and cash equivalents, provide us with
limited liquidity. We believe our existing cash and cash will allow
us to fund our operating plan through the fourth quarter of 2022.
We expect to continue to seek additional funding for our
operations. Any such required additional capital may not be
available on reasonable terms, if at all. If we were unable to
obtain additional financing, we may be required to reduce the scope
of, delay or eliminate some or all of our planned clinical testing,
research and development and commercialization activities, which
could harm our business. The sale of additional equity or debt
securities may result in additional dilution to our shareholders.
If we raise additional funds through the issuance of debt
securities or preferred stock, these securities could have rights
senior to those of our common stock and could contain covenants
that would restrict our operations. We also will require additional
capital beyond our currently forecasted amounts.
For
example, as we seek to move forward with the development of
NT-CoV2-1 vaccine candidate and our other product candidates, we
will require additional capital. In addition, we continue to pursue
other COVID-19 research and development funding opportunities
through governmental and nongovernmental sources, as well as
potential research collaboration arrangements with academic
institutions and other commercial partners. Our ability to advance
the development of our NT-CoV2-1 vaccine candidate at our currently
anticipated pace, in accordance with our License agreements, is
dependent upon our ability to secure additional capital resources
through these funding opportunities or an alternative capital
raise, such as an equity or debt financing or other strategic
business collaboration. Moreover, the global impact of COVID-19
could further impact our need for additional capital if we
experience delays in our anticipated timelines or achievement
milestones.
Because
of the numerous risks and uncertainties associated with research,
development and clinical testing of our product candidates, we are
unable to estimate the exact amounts of our working capital
requirements. Our future funding requirements will depend on many
factors, including, but not limited to:
|
● |
conducting
preclinical research for our NT-CoV2-1vaccine product candidate,
filing an IND with the FDA and, if approved, engage in Phase 1
clinical trials; |
|
|
|
|
● |
our
ability to partner or collaborate with third parties; |
|
|
|
|
● |
identifying
and securing clinical sites for the conduct of human trials for our
product candidates; |
|
|
|
|
● |
the
number and characteristics of the product candidates we
pursue; |
|
|
|
|
● |
the
scope, progress, results and costs of researching and developing
our product candidates, and conducting nonclinical and clinical
trials; |
|
|
|
|
● |
the
timing of, and the costs involved in, obtaining regulatory
approvals for our product candidates; |
|
|
|
|
● |
our
ability to maintain current research and development licensing
agreements and to establish new strategic partnerships, licensing
or other arrangements and the financial terms of such
agreements; |
|
|
|
|
● |
our
ability to advance our lantibiotic development or achieve
milestones under our License Agreements and the payment obligations
we may have; |
|
|
|
|
● |
the
costs involved in preparing, filing, prosecuting, maintaining,
defending and enforcing patent claims, including litigation costs
and the outcome of such litigation; and |
|
|
|
|
● |
the
timing, receipt and amounts of sales of, or royalties on, our
products and future products, if any. |
We
have based our estimates on assumptions that may prove to be wrong.
We may need to obtain additional funds sooner or in greater amounts
than we currently anticipate. Potential sources of financing
include strategic relationships, grants, public or private sales of
our shares or debt and other sources. We may seek to access the
public or private equity markets when conditions are favorable due
to our long-term capital requirements. We do not have any committed
sources of financing at this time, and it is uncertain whether
additional funding will be available when we need it on terms that
will be acceptable to us, or at all. If we raise funds by selling
additional shares of common stock or other securities convertible
into common stock, the ownership interest of our existing
stockholders will be diluted. If we are not able to obtain
financing when needed, we may be unable to carry out our business
plan. As a result, we may have to significantly limit our
operations and our business, financial condition and results of
operations would be materially harmed.
Critical
Accounting Estimates and Policies
Our
discussion and analysis of our financial condition and results of
operations are based upon our consolidated financial statements,
which have been prepared in accordance with accounting principles
generally accepted in the United States of America (“US GAAP”). The
preparation of consolidated financial statements in accordance with
US GAAP requires us to make estimates and assumptions that affect
reported amounts and related disclosures. We consider an accounting
estimate to be critical if it requires assumptions to be made that
were uncertain at the time the estimate was made; and changes in
the estimate or different estimates that could have been made could
have a material impact on our results of operations or financial
condition. The principal area of estimation reflected in the
consolidated financial statements is stock-based compensation. For
a detailed discussion of our critical accounting estimates, see our
Annual Report on Form 10-K for the year ended December 31, 2021
There have been no material changes to our critical accounting
estimates during the three and six months ended June 30,
2022.
Recently
Issued Accounting Pronouncements
There
are no accounting pronouncements issued or effective during the
three and six months ended June 30, 2022 that have had or are
expected to have an impact on our consolidated financial
statements.
ITEM 3. |
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Oragenics,
Inc. is a smaller reporting company as defined by Rule 12b-2 of the
Securities and Exchange Act of 1934 and is not required to provide
the information required under this item.
ITEM 4. |
CONTROLS
AND PROCEDURES |
Evaluation
of Disclosure Controls and Procedures
Management’s
evaluation of the effectiveness of the Company’s disclosure
controls and procedures as defined in Rules 13a-15(e) and 15d-15(e)
of the Securities Exchange Act was performed under the supervision
and participation of our senior management, including our Principal
Executive Officer and Chief Financial Officer. The purpose of
disclosure controls and procedures is to ensure that information
required to be disclosed in the reports filed or submitted under
the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the SEC’s rules and forms, and
that such information is accumulated and communicated to
management, including our Principal Executive Officer and Chief
Financial Officer, to allow timely decisions regarding required
disclosures. Based upon that evaluation, our Principal Executive
Officer and Chief Financial Officer concluded that, as of the end
of such period, our disclosure controls and procedures were
effective as of June 30, 2022 in ensuring that information required
to be disclosed by us in reports that we file or submit under the
Exchange Act is recorded, processed, summarized and reported with
the time periods specified in the Securities and exchange
Commission’s rules and forms.
Changes
in Internal Controls over Financial Reporting
Our
management, with the participation of our Principal Executive
Officer and Chief Financial Officer, has concluded there were no
significant changes in our internal controls over financial
reporting that occurred during our last fiscal quarter that has
materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
Limitations
on the Effectiveness of Controls
Our
management, including our Principal Executive Officer and Chief
Financial Officer, does not expect that our Disclosure Controls and
internal controls will prevent all errors and all fraud. A control
system, no matter how well conceived and operated, can provide only
reasonable, not absolute, assurance that the objectives of the
control system are met. Further, the design of a control system
must reflect the fact that there are resource constraints, and the
benefits of controls must be considered relative to their costs.
Because of the inherent limitations in all control systems, no
evaluation of controls can provide absolute assurance that all
control issues and instances of fraud, if any, within the Company
have been 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 or board override of the control.
The
design of any system of controls also is based in part upon certain
assumptions about the likelihood of future events, and there can be
no assurance that any design will succeed in achieving its stated
goals under all potential future conditions; over time, controls
may become inadequate because of changes in conditions, or the
degree of compliance with the policies or procedures may
deteriorate. Because of the inherent limitations in a
cost-effective control system, misstatements due to error or fraud
may occur and not be detected.
PART II – |
OTHER
INFORMATION |
|
|
ITEM
1. |
LEGAL
PROCEEDINGS |
We
are not a party to any pending legal proceeding that is not in the
ordinary course of business or otherwise material to our financial
condition or business.
In
addition to the other information set forth in this Form 10-Q, you
should carefully consider the factors discussed in Part I, Item 1A,
subsection “Risk Factors” of our Annual Report on Form 10-K for the
fiscal year ended December 31, 2021 which could materially affect
our business, financial condition or future results of operations.
The risks described in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2021 are not the only risks that we
face. Additional risks and uncertainties not currently known to us
or that we currently deem to be immaterial may also materially
adversely affect our business, financial condition and future
results of operations. The following information updates, and
should be read in conjunction with, the risk factors previously
disclosed in Item 1A, subsection “Risk Factors” to Part I of our
Annual Report on Form 10-K for the fiscal year ended December 31,
2021 filed on March 24, 2022. Except as set forth below, there have
been no material changes to the risk factors previously disclosed
under the caption “Risk Factors” in our Annual Report on Form
10-K.
Risks
Related to Our Business
We have incurred significant losses since our inception and expect
to continue to experience losses for the foreseeable
future.
We
have incurred significant net losses and negative cash flow in each
year since our inception, including net losses of approximately and
$10.1 million and $9.0 million for the six months ended June 30,
2022 and June 30, 2021, respectively, and approximately $15.7
million and $26.4 million for the years ended December 31, 2021,
and 2020, respectively. As of June 30, 2022, our accumulated
deficit was approximately $181.3 million. We have devoted a
significant amount of our financial resources to research and
development, including our nonclinical development activities and
clinical trials. We expect that the costs associated with our plans
to begin preclinical research, contract manufacturing and file an
IND for our NT-CoV2-1 vaccine product candidate and the research
and development of our product candidates in the area of
lantibiotics (“Lantibiotics Program”) will continue to increase the
level of our overall expenses significantly going forward.
Additionally, our License Agreements also requires the payment of
certain recurring and performance-based royalties that may
negatively impact our financial capabilities. As a result, we
expect to continue to incur substantial net losses and negative
cash flow for the foreseeable future. These losses and negative
cash flows have had, and will continue to have, an adverse effect
on our shareholders’ equity and working capital. Because of the
numerous risks and uncertainties associated with product
development and commercialization, we are unable to accurately
predict the timing or amount of substantial expenses or when, or
if, we will be able to generate the revenue necessary to achieve or
maintain profitability.
We will need to raise additional capital in the future to complete
the development and commercialization of our product candidates and
operate our business.
Developing
and commercializing biopharmaceutical products, including
conducting nonclinical studies and clinical trials and establishing
manufacturing capabilities, and the progress of our efforts to
develop and commercialize our product candidates, including our
acquisition of a vaccine product candidate is expensive, and can
cause us to use our limited, available capital resources faster
than we currently anticipate. We anticipate that our cash resources
as of June 30, 2022, will be sufficient to fund our operations as
presently structured through the fourth quarter of 2022. Our actual
costs may ultimately vary from our current expectations, which
could materially impact our use of capital and our forecast of the
period of time through which our financial resources will be
adequate to support our operations. Our current cash, cash
equivalents and short-term investments are not sufficient to fully
implement our business strategy and sustain our operations.
Accordingly, we will need to seek additional sources of financing
and such additional financing may not be available on favorable
terms, if at all. Until we can generate a sufficient amount of
product revenue, if ever, we expect to finance future cash needs
through public or private equity offerings, debt financings or
corporate or government collaboration and licensing arrangements.
If we do not succeed in raising additional funds on acceptable
terms, we may be unable to complete existing nonclinical and
planned clinical trials or obtain approval of our product
candidates from the FDA and other regulatory authorities. We expect
capital outlays and operating expenditures to increase over the
next several years as we expand our infrastructure, and research
and development activities. Specifically, we need to raise
additional capital to, among other things:
|
● |
conduct
preclinical research for our NT-CoV-2-1 vaccine product candidate,
file an IND with the FDA and, if approved, engage in Phase 1
clinical trials; |
|
● |
engage
in GMP and non-GMP manufacturing for our product candidates at the
preclinical research and clinical trial stages; |
|
|
|
|
● |
expand
our clinical laboratory operations and conduct further research and
development on lantibiotics; |
|
|
|
|
● |
fund
our clinical validation study activities; |
|
|
|
|
● |
expand
our research and development activities; and |
|
|
|
|
● |
finance
our capital expenditures and general and administrative
expenses. |
Our
present and future funding requirements will depend on many
factors, including:
|
● |
the
level of research and development investment budgeted to develop
our current and future product candidates through each phase of
development; |
|
|
|
|
● |
the
timing, scope, progress, results and cost of research and
development, testing, screening, manufacturing, preclinical and
non-clinical studies and clinical trials, including any impacts
related to the COVID-19 pandemic;; |
|
|
|
|
● |
costs
of filing, prosecuting, defending and enforcing patent claims and
other intellectual property rights; |
|
|
|
|
● |
our
need or decision to acquire or license complementary technologies
or acquire complementary businesses; |
|
|
|
|
● |
changes
in test development plans needed to address any difficulties in
product candidate selection for commercialization; |
|
|
|
|
● |
competing
vaccine and technological and market developments; |
|
|
|
|
● |
our
interaction and relationship with the FDA, or other, regulatory
agencies; and |
|
|
|
|
● |
changes
in regulatory policies or laws that affect our
operations. |
Additional
capital, if needed, may not be available on satisfactory terms, or
at all. Furthermore, if we raise additional funds by issuing equity
securities, dilution to our existing stockholders could result. Any
equity securities issued also may provide for rights, preferences
or privileges senior to those of holders of our common stock. If we
raise additional funds by issuing debt securities, these debt
securities would have rights, preferences and privileges senior to
those of holders of our common stock, and the terms of the debt
securities issued could impose significant restrictions on our
operations. If we raise additional funds through collaborations and
licensing arrangements, we might be required to relinquish
significant rights to our technologies or our products under
development or grant licenses on terms that are not favorable to
us, which could lower the economic value of those programs to us.
If adequate funds are not available, we may have to scale back our
operations or limit our research and development activities, which
may cause us to grow at a slower pace, or not at all, and our
business could be adversely affected.
In
addition, we could be forced to discontinue product development and
commercialization of one or more of our product candidates, curtail
or forego sales and marketing efforts, and/or forego licensing
attractive business opportunities.
ITEM 2. |
UNREGISTERED
SALE OF EQUITY SECURITIES AND USE OF PROCEEDS |
None.
ITEM 3. |
DEFAULTS
UPON SENIOR SECURITIES |
None.
ITEM 4. |
MINE
SAFETY DISCLOSURES |
Not
Applicable.
ITEM 5. |
OTHER
INFORMATION |
None.
Incorporated
by reference to Exhibits filed after signature page.
EXHIBIT
INDEX
|
|
|
|
Incorporated
by Reference |
|
|
|
|
Exhibit
number
|
|
Exhibit
description |
|
Form |
|
File
no. |
|
Exhibit |
|
Filing
date
|
|
Filed
herewith
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.1 |
|
Amended
and Restated Articles of Incorporation as amended prior to December
29, 2017 (including certificates of designation of Series A, B and
C Preferred Stock) |
|
8-K |
|
001-32188 |
|
3.1 |
|
12/29/17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.2 |
|
Articles
of Amendment to Amended and Restated Articles of Incorporation
dated effective December 29, 2017 |
|
8-K |
|
001-32188 |
|
3.2 |
|
12/29/17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.3 |
|
Articles
of Amendment to Amended and Restated Articles of Incorporation
effective January 19, 2018 |
|
8-K |
|
001-32188 |
|
3.1 |
|
1/19/18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.4 |
|
Articles
of Amendment to Amended and Restated Articles of
Incorporation |
|
8-K |
|
001-32188 |
|
3.4 |
|
6/26/18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.5 |
|
Articles
of Amendment to Amended and Restated Articles of
Incorporation |
|
8-K |
|
001-32188 |
|
3.5 |
|
2/28//22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.6 |
|
Bylaws |
|
SB-2 |
|
333-100568 |
|
3.2 |
|
10/16/02 |
|
|
|
|
|
|
|
|
|
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3.7 |
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First
Amendment to Bylaws |
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8-K |
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001-32188 |
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3.1 |
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6/9/10 |
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3.8 |
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Second
Amendment to Bylaws |
|
8-K |
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001-32188 |
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3.1 |
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8/24/10 |
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3.9 |
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Third
Amendment to Bylaws |
|
8-K |
|
001-32188 |
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3.9 |
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2/28/22 |
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10.1 |
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National
Research Council (NRC) Canada Technology License Agreement (dated
July 26, 2021) and Amendment One (dated September 2,
2021).* |
|
10-Q |
|
001-32188 |
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10.0 |
|
11/15/21 |
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10.2 |
|
NRC
Technology License Amendment 2 |
|
10-K |
|
001-32188 |
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10.6 |
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3/24/22 |
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10.3 |
|
NRC
Technology License Amendment 3 |
|
10-K |
|
001-32188 |
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10.7 |
|
3/24/22 |
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10.4 |
|
NRC
Technology License Amendment 4 |
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X |
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31.1 |
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Certification
of Principal Executive Officer pursuant to Rule 13a-14 and Rule
15d-14(a), promulgated under the Securities and Exchange Act of
1934, as amended. |
|
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X |
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31.2 |
|
Certification
of Principal Financial Officer pursuant to Rule 13a-14 and Rule
15d-14(a), promulgated under the Securities and Exchange Act of
1934, as amended. |
|
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X |
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32.1 |
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 (Principal Executive
Officer). |
|
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X |
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32.2 |
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 (Chief Financial
Officer). |
|
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X |
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|
101.INS |
|
Inline
XBRL Instance Document |
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101.SCH |
|
Inline
XBRL Taxonomy Extension Schema |
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X |
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101.CAL |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase |
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X |
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101.DEF |
|
Inline
XBRL Taxonomy Extension Definition Linkbase |
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X |
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101.LAB |
|
Inline
XBRL Taxonomy Extension Label Linkbase |
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X |
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101.PRE |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase |
|
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X |
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104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL
document |
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* |
Confidential treatment has been granted as to certain portions of
this exhibit pursuant to Rule 406 of the Securities Act of 1933, as
amended, or Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. |
SIGNATURES
In
accordance with the requirements of the Exchange Act, the
registrant caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized on this 9th day
of August, 2022.
ORAGENICS,
INC. |
|
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|
|
BY: |
/s/
Kimberly Murphy |
|
|
Kimberly
Murphy, President and Chief Executive Officer and Principal
Executive Officer |
|
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|
|
BY: |
/s/
Michael Sullivan |
|
|
Michael
Sullivan, Chief Financial Officer and Principal Accounting
Officer |
|
Oragenics (AMEX:OGEN)
Graphique Historique de l'Action
De Déc 2022 à Jan 2023
Oragenics (AMEX:OGEN)
Graphique Historique de l'Action
De Jan 2022 à Jan 2023