Notes
to the Condensed Consolidated Financial Statements
(Unaudited)
Note
1 – Nature of Business
Immix
Biopharma, Inc. (the “Company”) is a clinical-stage pharmaceutical company organized as a Delaware corporation on January
7, 2014 to focus on the development of therapies for patients with cancer and inflammatory diseases. In August 2016, the Company established
a wholly-owned Australian subsidiary, Immix Biopharma Australia Pty Ltd. (“IBAPL”), in order to conduct various preclinical
and clinical activities for its development candidates. In November 2022, the Company established a majority-owned subsidiary, Nexcella,
Inc. (formerly known as Immix Biopharma Cell Therapy, Inc.) (“Nexcella”) in order to conduct various preclinical and clinical
activities for its development candidates.
Note
2 – Summary of Significant Accounting Policies
The
accompanying condensed consolidated financial statements and related notes have been prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”) and in accordance with the rules and regulations of the
United States Securities and Exchange Commission (the “SEC”). The Company’s fiscal year end is December 31.
The
condensed consolidated financial statements and related disclosures as of March 31, 2023 and for the three months ended March 31, 2023
and 2022 are unaudited, pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally included
in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations.
In the Company’s opinion, these unaudited condensed consolidated financial statements include all adjustments (consisting only
of normal recurring adjustments) necessary for the fair statement of the results for the interim periods. These unaudited condensed consolidated
financial statements should be read in conjunction with the audited financial statements of the Company for the years ended December
31, 2022 and 2021 which are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 27, 2023. The results
of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the full year
ending December 31, 2023.
Risk
and Uncertainties - The Company operates in a dynamic and highly competitive industry and is subject to risks and uncertainties common
to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological
innovations, protection of proprietary technology, dependence on key personnel, contract manufacturer and contract research organizations,
compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under
development will require significant additional research and development efforts, including extensive preclinical studies and clinical
trials and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate
personnel infrastructure and extensive compliance and reporting. The Company believes that changes in any of the following areas could
have a material adverse effect on the Company’s future financial position, results of operations, or cash flows; ability to obtain
future financing; advances and trends in new technologies and industry standards; results of clinical trials; regulatory approval and
market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims
against the Company based on intellectual property, patent, product, regulatory, or other factors; and the Company’s ability to
attract and retain employees necessary to support its growth.
Products
developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory
agencies prior to commercial sales. There can be no assurance that the Company’s research and development will be successfully
completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that the products will
receive the necessary approvals, or that any approved products will be commercially viable. If the Company is denied approval, approval
is delayed or the Company is unable to maintain approval, it could have a material adverse impact on the Company. Even if the Company’s
product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The
Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology
companies. In addition, the Company is dependent upon the services of its employees, consultants and other third parties.
The
Company has expended and will continue to expend substantial funds to complete the research, development and clinical testing of product
candidates. The Company also will be required to expend additional funds to establish commercial-scale manufacturing arrangements and
to provide for the marketing and distribution of products that receive regulatory approval. The Company may require additional funds
to commercialize its products. The Company is unable to entirely fund these efforts with its current financial resources. If adequate
funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the
scope of or eliminate one or more of its research or development programs which may materially and adversely affect its business, financial
condition and operations.
Use
of Estimates in Financial Statement Presentation – The preparation of these condensed consolidated financial statements in
conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. The Company uses
significant judgements when making estimates related to the valuation of deferred tax assets and related valuation allowances, accrual
and prepayment of research and development expenses, and the valuation of stock-based compensation. Actual results could differ from
those estimates.
Principles
of Consolidation – The accompanying condensed consolidated financial statements include the accounts of Immix
Biopharma, Inc., the accounts of its 100%
owned subsidiary, IBAPL, and the accounts of its majority-owned subsidiary, Nexcella. All intercompany transactions and balances
have been eliminated in consolidation. For consolidated entities where the Company owns less than 100%
of the subsidiary, the Company records net loss attributable to non-controlling interests in its condensed consolidated statements
of operations and comprehensive loss equal to the percentage of the economic or ownership interest retained in such entities by the
respective non-controlling parties.
Liquidity
and Going Concern – These condensed consolidated financial statements have been prepared on a going concern basis,
which assumes the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The
continuation of the Company as a going concern is dependent upon the ability of the Company to obtain financing to continue
operations. In December 2021, the Company received $18,648,934
in net proceeds from the initial public offering (“IPO”) of its common stock. In January 2022, the Company raised
additional net proceeds of $2,913,750
from the exercise of the underwriter’s over-allotment option in connection with the Company’s IPO. On March 22, 2023,
the Company entered into an ATM Sales Agreement (the “Sales Agreement”) with ThinkEquity LLC (the “Sales
Agent”), pursuant to which the Company, may, from time to time, issue and sell through the Sales Agent, up to $5
million of shares of the Company’s common stock in sales deemed to be
“at-the-market offerings” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended
(the “ATM Facility”) (see Note 4). As of May 11, 2023, the Company has raised net proceeds of $2,611,843
under the ATM Facility.
The
Company has a history of, and expects to continue to report, negative cash flows from operations and a net loss. While the Company’s
estimates of its operating expenses and working capital requirements could be incorrect and the Company may use its cash resources faster
than it anticipates, management believes that its cash on hand at March 31, 2023 and funds that may be raised from the ATM Facility,
will be sufficient to meet the Company’s working capital requirements through at least May 12, 2024.
Concentration
of Credit Risk – Periodically, the Company may carry cash and cash equivalents balances at financial institutions in
excess of the federally insured limit of $250,000,
or the Australian insured limit of AUD 250,000.
As of March 31, 2023, the Company had $11,167,892
in excess of the FDIC insurance limit and no
amounts in excess of the Australian insured limit. The Company has not experienced losses on these accounts and management believes
that the credit risk with regard to these deposits is not
significant.
Cash
and Cash Equivalents – The Company’s cash equivalents include short-term highly liquid investments with an original maturity
of 90 days or less when purchased and are carried at fair value.
Fair
Value of Financial Instruments – The carrying value of short-term instruments, including cash and cash equivalents, tax receivable,
accounts payable and accrued expenses, approximate fair value due to the relatively short period to maturity for these
instruments.
Fair
value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal
or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The
Company utilizes a three-level valuation hierarchy for disclosures of fair value measurements, defined as follows:
Level
1 – inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level
2 – inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs
that are observable for the assets or liability, either directly or indirectly, for substantially the full term of the financial instruments.
Level
3 – inputs to the valuation methodology are unobservable and significant to the fair value.
The
following fair value hierarchy tables presents information about the Company’s asset measured at fair value on a recurring basis:
Schedule
of Asset Measured at Fair Value on a Recurring Basis
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
Fair Value Measurements at March 31, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
Assets: | |
| | | |
| | | |
| | |
Cash equivalents (money market funds) | |
$ | 11,167,892 | | |
$ | - | | |
$ | - | |
As of March 31, 2023, the Company had no liabilities required to be measured at fair value on a recurring basis.
As
of December 31, 2022, the Company had no assets or liabilities required to be measured at fair value on a recurring
basis.
Australian
Tax Incentive – IBAPL is eligible to receive a cash refund from the Australian Taxation Office for eligible research and development
(“R&D”) expenditures under the Australian R&D Tax Incentive Program (the “Australian Tax Incentive”).
The Australian Tax Incentive is recognized as a reduction to R&D expense when there is reasonable assurance that the relevant expenditure
has been incurred, the amount can be reliably measured and that the Australian Tax Incentive will be received. The Company recognized
reductions to R&D expense of $72,188 and $35,960 for the three months ended March 31, 2023 and 2022, respectively.
Deferred
Offering Costs – The Company has capitalized qualified legal, accounting and other direct costs related to its efforts to raise
capital through the sale of its common stock under the ATM Facility. Deferred offering costs will be deferred and amortized ratably upon
sales under the ATM Facility, and upon completion, they will be reclassified to additional paid-in capital as a reduction of the ATM
proceeds. If the Company terminates the ATM Facility or there is a significant delay, all of the deferred offering costs will be immediately
written off to operating expenses. As of March 31, 2023, $118,407 of deferred offering costs were capitalized related to the ATM Facility, which are included in other assets in the accompanying condensed consolidated
balance sheet.
The
Company has capitalized qualified legal, accounting and other direct costs related to its efforts to raise capital on behalf of its wholly-owned subsidiary, Nexcella. Deferred
offering costs will be deferred until such capital raising is completed, at which time they will be reclassified to additional
paid-in capital as a reduction of the Nexcella proceeds. If the Company terminates the Nexcella capital raising efforts or there is a
significant delay, all of the deferred offering costs will be immediately written off to operating expenses. As of March 31, 2023,
$56,724
of deferred offering costs were capitalized, which are included in other assets in the accompanying condensed consolidated
balance sheet.
Stock-Based
Compensation – Stock-based compensation expense represents the estimated grant date fair value of the Company’s equity
awards, consisting of stock options issued under the Company’s stock option plan and restricted common stock (see Note 4). The
fair value of equity awards is recognized over the requisite service period of such awards (usually the vesting period) on a straight-line
basis. The Company estimates the fair value of stock options using the Black-Scholes option pricing model on the date of grant and recognizes
forfeitures as they occur. For stock awards for which vesting is subject to performance-based milestones, the expense is recorded over
the remaining service period after the point when the achievement of the milestone is probable, or the performance condition has been
achieved.
Research
and Development Costs – R&D costs are expensed as incurred. R&D costs consist primarily of clinical research fees paid
to consultants and outside service providers, other expenses relating to design, development and testing of the Company’s therapy
candidates, and for license and milestone costs related to in-licensed products and technology. Costs incurred in obtaining technology
licenses are charged to R&D expense if the technology licensed has not reached commercial feasibility and has no
alternative future use. Such licenses purchased by the Company require substantial completion of research and development, regulatory
and marketing approval efforts in order to reach commercial feasibility and has no alternative future use.
Clinical
trial costs are a component of R&D expenses. The Company estimates expenses incurred for clinical trials that are in process based
on services performed under contractual agreements with clinical research organizations and actual clinical investigators. Included in
the estimates are (1) the fee per patient enrolled as specified in the clinical trial contract with each institution participating in
the clinical trial and (2) progressive data on patient enrollments obtained from participating clinical trial sites and the actual services
performed. Changes in clinical trial assumptions, such as the length of time estimated to enroll all patients, rate of screening failures,
patient drop-out rates, number and nature of adverse event reports, and the total number of patients enrolled can impact the average
and expected cost per patient and the overall cost of the clinical trial. The Company monitors the progress of the trials and their related
activities and adjusts expense accruals, when applicable. Adjustments to accruals are charged to expense in the period in which the facts
give rise to the adjustments become known.
Other
Comprehensive Income (Loss) – Other comprehensive income (loss) includes foreign currency translation gains and losses. The
cumulative amount of translation gains and losses are reflected as a separate component of stockholders’ equity in the condensed
consolidated balance sheets, as accumulated other comprehensive income.
Foreign
Currency Translation and Transaction Gains (Losses) – The Company, and its majority-owned subsidiary
Nexcella, maintain their accounting records in U.S. Dollars. The Company’s
operating subsidiary, IBAPL, is located in Australia and maintains its accounting records in Australian Dollars, which is its functional
currency. Assets and liabilities of the subsidiary are translated into U.S. dollars at exchange rates at the balance sheet date, equity
accounts are translated at historical exchange rate and revenues and expenses are translated by using the average exchange rates for
the period. Translation adjustments are reported as a separate component of other comprehensive income (loss) in the consolidated statements
of operations and comprehensive loss. Foreign currency denominated transactions are translated at exchange rates approximating those
in effect at the transaction dates. Gains (losses) resulting from foreign currency transactions are included in general and administrative
expenses in the accompanying condensed consolidated statements of operations and comprehensive loss and were $(274) and $7,615 for the
three months ended March 31, 2023 and 2022, respectively.
Loss
Per Common Share - Basic loss per common share is computed by dividing net loss available to common stockholders by the weighted-average
number of common shares outstanding during the period. Diluted loss per common share is determined using the weighted-average number
of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses
are reported, the weighted-average number of common shares outstanding excludes common stock equivalents because their inclusion would
be anti-dilutive. As of March 31, 2023 and 2022, the Company’s potentially dilutive shares, which were not included in the calculation
of net loss per share, included stock options and warrants exercisable for 2,168,742 and 1,729,734 shares of common stock, respectively.
Recent
Accounting Pronouncements
The
Company does not believe that any recently issued effective pronouncements, or pronouncements issued but not yet effective, if adopted,
would have a material effect on the accompanying condensed consolidated financial statements.
Note
3 – Agreements with Nexcella Subsidiary
Founders
Agreement
Effective
December 8, 2022, the Company entered into a Founders Agreement with Nexcella (the “Nexcella Founders
Agreement”).
The
Nexcella Founders Agreement provides that prior to a Qualified IPO (as defined in Nexcella’s Amended and Restated Certificate of
Incorporation, as amended (the “Nexcella COI”)) or Qualified Change in Control (as defined in the Nexcella COI), the Company
shall provide funds to Nexcella as requested by Nexcella, in good faith, to be evidenced by a senior unsecured promissory note. In exchange
for the time and capital expended in the formation of Nexcella and the identification of specific assets, the acquisition of which benefit
Nexcella, on December 21, 2022, the Company loaned Nexcella approximately $2.1 million, evidenced by a senior unsecured promissory note,
representing the up-front fee required to acquire Nexcella’s license agreement with Hadasit Medica Research Services & Development,
Ltd. (“HADASIT”) and BIRAD Research and Development Company Ltd. (“BIRAD”), and for use as working capital for
its research and development activities. The note, which matures on January 31, 2030, accrues interest at a rate of 7.875% per annum
and is convertible into shares of common stock of Nexcella at a conversion price of $2.00 per share, subject to adjustment; provided,
however, that such note shall automatically convert into shares of Nexcella common stock immediately prior to certain conversion triggers
set forth in the note. Nexcella may not prepay the note without the Company’s prior written consent. The Nexcella Founders Agreement
has a term of 15 years, which, upon expiration, automatically renews for successive one-year periods unless terminated by the Company
upon notice at least six months prior to the end of the term or upon the occurrence of a Change of Control (as defined in the Nexcella
Founders Agreement). In connection with the Nexcella Founders Agreement, the Company was issued 250,000 shares of Nexcella’s Class
A Preferred Stock, 1,000,000 shares of Nexcella’s Class A Common Stock, and 5,000,000 shares of Nexcella’s common stock.
The Class A Preferred Stock is identical to the common stock other than as to conversion rights and the PIK Dividend right (as defined
below) and voting rights.
Each
share of Class A Preferred Stock is convertible, at the Company’s option, into one fully paid and nonassessable share of Nexcella’s
common stock, subject to certain adjustments. As a holder of Nexcella’s Class A Preferred Stock, the Company will receive on each
March 13 (each a “PIK Dividend Payment Date”) until the date all outstanding Class A Preferred Stock is converted into Nexcella’s
common stock or redeemed (and the purchase price is paid in full), pro rata per share dividends paid in additional fully paid and nonassessable
shares of Nexcella common stock (“PIK Dividends”) such that the aggregate number of shares of common stock issued pursuant
to such PIK Dividend is equal to 2.5% of Nexcella’s fully-diluted outstanding capitalization on the date that is one business day
prior to any PIK Dividend Payment Date. In addition, as a holder of Class A Preferred Stock, the Company shall be entitled to cast for
each share of Class A Preferred Stock held as of the record date for determining stockholders entitled to vote on matters presented to
the stockholders of Nexcella, the number of votes that is equal to 1.1 times a fraction, the numerator of which is the sum of (A) the
shares of outstanding Nexcella common stock and (B) the whole shares of Nexcella common stock into which the shares of outstanding Nexcella
Class A Common Stock and the Class A Preferred Stock are convertible and the denominator of which is number of shares of outstanding
Nexcella Class A Preferred Stock.
Each
share of Class A Common Stock is convertible, at the Company’s option, into one fully paid and nonassessable share of Nexcella’s
common stock, subject to certain adjustments. In addition, upon a Qualified IPO (as defined the Nexcella COI) or Qualified Change
in Control (as defined in the Nexcella COI), the shares of Class A Common Stock, will automatically convert into one fully paid and nonassessable
share of Nexcella’s common stock; provided however, if at that time, the Class A Common Stock is not then convertible into a number
of shares of Nexcella common stock (or such other capital stock or securities at the time issuable upon the conversion of the Class A
Common Stock) that have a value of: (a) in the case of a Qualified IPO, at least $5,000,000 based on the initial offering price in such
initial public offering, or (b) in the case of a Qualified Change in Control, at least $5,000,000 in cash or at least $5,000,000 of equity
based on the implied value of a share of Nexcella common stock resulting from the price paid upon the consummation of such Qualified
Change of Control, the Class A Common Stock will automatically convert into such number of shares of Nexcella common stock (or such other
capital stock or securities at the time issuable upon the conversion of the Class A Common Stock) that have a value of $5,000,000 based
in the initial offering price in such initial public offering or the implied value of a share of Nexcella common stock resulting from
the price paid upon the consummation of such Qualified Change of Control (or if such Qualified Change of Control results in the Class
A Shares being exchanged solely for cash, then $5,000,000 in cash). The Company shall be entitled to cast such number of votes equal
to the number of whole shares of Nexcella common stock into which the Company’s Class A Common Stock is convertible as of the record
date for determining stockholders entitled to vote on matters presented to the stockholders of Nexcella.
In
addition to the foregoing, the Company shall be entitled to one vote for each share of Nexcella common stock held by it. Except as provided
by law or by the Nexcella COI, holders of Nexcella Class A Common Stock and Class A Preferred Stock shall vote together with the holders
of Nexcella common stock, as a single class.
As
additional consideration under the Nexcella Founders Agreement, Nexcella will also: (i) pay an equity fee in shares of common stock,
payable within five business days of the closing of any equity or debt financing for Nexcella or any of its respective subsidiaries that
occurs after the effective date of the Nexcella Founders Agreement and ending on the date when the Company no longer has majority voting
control in Nexcella’s voting equity, equal to 2.5% of the gross amount of any such equity or debt financing; and (ii) pay a cash
fee equal to 4.5% of Nexcella’s annual Net Sales (as defined in the Nexcella Founders Agreement), payable on an annual basis, within
90 days of the end of each calendar year. In the event of a Change of Control, Nexcella will pay a one-time change in control fee equal
to five times the product of (A) Net Sales for the 12 months immediately preceding the Change of Control and (B) 4.5%.
Management
Services Agreement
Effective
as of December 8, 2022, the Company entered into a Management Services Agreement (the “Nexcella MSA”) with Nexcella. Pursuant
to the terms of the Nexcella MSA, the Company will render management, advisory and consulting services to Nexcella. Services provided
under the Nexcella MSA may include, without limitation, (i) advice and assistance concerning any and all aspects of Nexcella’s
operations, clinical trials, financial planning and strategic transactions and financings and (ii) conducting relations on behalf of
Nexcella with accountants, attorneys, financial advisors and other professionals (collectively, the “Services”). At the request
of the Company, Nexcella shall utilize clinical research services, medical education, communication and marketing services and investor
relations/public relation services of companies or individuals designated by the Company, provided those services are offered at market
prices. In consideration for the Services, Nexcella will pay the Company an annual base management and consulting fee of $500,000 (the
“Annual Consulting Fee”), payable in advance in equal quarterly installments on the first business day of each calendar quarter
in each year; provided, however, that such Annual Consulting Fee shall be increased to $1.0 million for each calendar year in which Nexcella
has Net Assets (as defined in the Nexcella MSA) in excess of $100 million at the beginning of the calendar year. Notwithstanding the
foregoing, the first Annual Consulting Fee payment shall be made on the first business day of the calendar quarter immediately following
the completion of the first equity financing for Nexcella that is in excess of $10 million in gross proceeds. The first payment shall
include all amounts in arrears from the effective date of the Nexcella MSA through such payment as well as the amounts in advance for
such first quarterly payment. Actual and direct out-of-pocket expenses reasonably incurred by the Company in performing the Services
shall be reimbursed to the Company by Nexcella. The Nexcella MSA shall continue for a period of five years from the effective date thereof
and shall be automatically extended for additional five year periods unless the Company and Nexcella provide written notice to not extend
the term at least 90 days prior to the end of the term, unless the Nexcella MSA is terminated earlier by mutual agreement of the Company
and Nexcella.
Note
4 – Stockholders’ Equity
The
Company has authorized 200,000,000 shares of common stock and 10,000,000 shares of preferred stock each with a par value of $0.0001 per
share.
ATM
Sales Agreement
On
March 22, 2023, the Company entered into the Sales Agreement with the Sales Agent pursuant to which the Company may offer and sell,
from time to time, through the Sales Agent, shares (the “Shares”) of the Company’s common stock, par value $0.0001
per share, having an aggregate offering price of up to $5,000,000,
subject to the terms and conditions set forth in the Sales Agreement. The Shares will be offered and sold pursuant to the
Company’s prospectus supplement, dated March 22, 2023, filed by the Company with the Securities and Exchange Commission (the
“SEC”) on March 22, 2023, including the accompanying base prospectus forming a part of the Company’s Registration Statement on Form S-3 (File No.
333-269100) filed by the Company with the SEC on January 3, 2023 and declared effective
by the SEC on January 11, 2023. The aggregate market value of Shares eligible for sale under the Sales Agreement will be subject to
the limitations of General Instruction I.B.6 of Form S-3.
Under
the Sales Agreement, the Sales Agent may sell the Shares in sales deemed to be “at-the-market offerings” as defined in Rule
415(a)(4) promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directly
on or through The Nasdaq Capital Market or any other existing trading market for the Company’s common stock, in negotiated transactions
at market prices prevailing at the time of sale or at prices related to such prevailing market prices, and/or any other method permitted
by law. The Company may instruct the Sales Agent not to sell any Shares if the sales cannot be effected at or above the price designated
by the Company from time to time.
The
Company will pay the Sales Agent a fixed commission rate of 3.75% of the aggregate gross proceeds from the sale of the Shares pursuant
to the Sales Agreement. The Company has paid an expense deposit of $15,000 to the Sales Agent, which will be applied against the actual
out-of-pocket accountable expenses that will be paid by the Company to the Sales Agent in connection with the offering. The Company has
agreed to reimburse the Sales Agent for all expenses related to the offering including, without limitation, the fees and expenses of
the Sales Agent’s legal counsel up to $50,000, and shall reimburse the Sales Agent, upon request, for such costs, fees and expenses
in an amount not to exceed $7,500 on a quarterly basis for the first three fiscal quarters of each year and $10,000 for the fiscal fourth
quarter of each year. The Company has also agreed to provide indemnification and contribution to the Sales Agent with respect to certain
liabilities, including liabilities under the Securities Act.
During
the three months ended March 31, 2023, the Company sold 50,000 shares pursuant to the ATM Facility for net cash proceeds of $103,916.
In addition, the Company amortized $2,593 of deferred offering costs for fees paid related to the ATM Facility.
Other
Common Stock Issuances
On
March 9, 2023, the Company entered into a marketing services agreement, whereby the Company agreed to issue 50,000
shares of its common stock valued at $97,500,
in exchange for six months of services. As of March 31, 2023, the Company has issued 6,700
shares of the Company’s common stock pursuant to the marketing services agreement. During the three months ended March 31,
2023, the Company recorded stock-based compensation expense of $9,590
related to the fair value of the shares of common stock, with the remaining fair value of the common stock of $87,910
to be recorded over the remaining service period.
Stock
Options
In
2016, the Board of Directors of the Company approved the Immix Biopharma, Inc. 2016 Equity Incentive Plan (the “2016 Plan”).
The 2016 Plan allows for the Board of Directors to grant various forms of incentive awards covering up to 417,120 shares of common stock.
During the year ended December 31, 2021, the Board of Directors amended the 2016 Plan to increase the aggregate number of shares available
for issuance under the 2016 Plan to 1,761,120 shares of common stock. On September 10, 2021, the Board of Directors approved the 2021
Equity Incentive Plan (the “2021 Plan”) which reserves and makes available for future issuance under the 2021 Plan (i) 900,000
shares of common stock, plus (ii) the number of shares of common stock reserved, but unissued under the 2016 Plan, and (iii) the number
of shares of common stock underlying forfeited awards under the 2016 Plan, provided that shares of common stock issued under the 2021
Plan with respect to an Exempt Award (as defined in the 2021 Plan) shall not count against such share limit. Subsequent to September
10, 2021, no further awards shall be issued under the 2016 Plan, but all awards under the 2016 Plan which were outstanding as of September
10, 2021 (including any Grandfathered Arrangement (as defined in the 2021 Plan)) shall continue to be governed by the terms, conditions
and procedures set forth in the 2016 Plan and any applicable award agreement. As of March 31, 2023, there are 635,622 shares of the Company’s common stock remaining
to be issued under the 2021 Plan.
The
Company recognized stock-based compensation of $178,360 and $65,074 related to stock options for the three months ended March 31, 2023
and 2022, respectively, which is included in general and administrative expenses. As of March 31, 2023, the Company had unrecognized
stock-based compensation expense of $1,375,931, related to unvested stock options, which is expected to be recognized over the weighted-average
vesting period of 2.93 years.
The
following table summarizes the stock option activity for the three months ended March 31, 2023:
Schedule of Stock Option Activity
| |
Options | | |
Weighted- Average Exercise Price Per Share | |
Outstanding and exercisable, January 1, 2023 | |
| 1,771,242 | | |
$ | 1.94 | |
Granted | |
| - | | |
$ | - | |
Exercised | |
| - | | |
$ | - | |
Forfeited | |
| - | | |
$ | - | |
Expired | |
| - | | |
$ | - | |
Outstanding and expected to vest, March 31, 2023 | |
| 1,771,242 | | |
$ | 1.94 | |
The
following table discloses information regarding outstanding and exercisable options at March 31, 2023:
Schedule of Stock Outstanding and Exercisable
| |
Outstanding | | |
Exercisable | |
Exercise Price | |
Number of Option Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Life (Years) | | |
Number of Option Shares | | |
Weighted Average Exercise Price | |
$0.80 | |
| 256,500 | | |
$ | 0.80 | | |
| 7.95 | | |
| 256,500 | | |
$ | 0.80 | |
$1.33 | |
| 150,992 | | |
$ | 1.33 | | |
| 2.42 | | |
| 150,992 | | |
$ | 1.33 | |
$1.86 | |
| 772,500 | | |
$ | 1.86 | | |
| 8.22 | | |
| 337,657 | | |
$ | 1.86 | |
$2.64 | |
| 580,000 | | |
$ | 2.64 | | |
| 9.29 | | |
| 136,669 | | |
$ | 2.64 | |
$5.83 | |
| 11,250 | | |
$ | 5.83 | | |
| 8.79 | | |
| 3,282 | | |
$ | 5.83 | |
| |
| 1,771,242 | | |
$ | 1.94 | | |
| 8.05 | | |
| 885,100 | | |
$ | 1.60 | |
Aggregate
intrinsic value is calculated as the difference between the exercise price of the underlying stock option and the fair value of the Company’s
common stock for stock options that were in-the-money at period end. As of March 31, 2023, the aggregate intrinsic value for the options
vested and outstanding was $335,113 and $335,113, respectively.
Stock
Warrants
The
following table summarizes the stock warrant activity for the three months ended March 31, 2023:
Schedule of Stock Warrant Activity
| |
Warrants | | |
Weighted-Average Exercise Price Per Share | |
Outstanding and exercisable, January 1, 2023 | |
| 397,500 | | |
$ | 4.11 | |
Granted | |
| - | | |
$ | - | |
Exercised | |
| - | | |
$ | - | |
Forfeited | |
| - | | |
$ | - | |
Expired | |
| - | | |
$ | - | |
Outstanding and exercisable, March 31, 2023 | |
| 397,500 | | |
$ | 4.11 | |
The
following table discloses information regarding outstanding and exercisable warrants at March 31, 2023:
Schedule of Stock Outstanding and Exercisable
| |
Outstanding | | |
Exercisable | |
Exercise Price | |
Number of Option Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Life (Years) | | |
Number of Option Shares | | |
Weighted Average Exercise Price | |
$0.80 | |
| 156,000 | | |
$ | 0.80 | | |
| 7.99 | | |
| 156,000 | | |
$ | 0.80 | |
$6.25 | |
| 241,500 | | |
$ | 6.25 | | |
| 3.71 | | |
| 241,500 | | |
$ | 6.25 | |
| |
| 397,500 | | |
$ | 4.11 | | |
| 5.39 | | |
| 397,500 | | |
$ | 4.11 | |
Aggregate
intrinsic value is calculated as the difference between the exercise price of the underlying stock warrant and the fair value of the
Company’s common stock for stock warrants that were in-the-money at period end. As of March 31, 2023, the intrinsic value for the
warrants vested and outstanding was $159,120.
Nexcella
Equity Transactions
As
of March 31, 2023, our controlling interest, on a fully dilutive basis, of Nexcella represents 94% of the total common stock equivalents
outstanding.
The
Nexcella 2022 Plan allows for the Board of Directors to grant various forms of incentive awards covering i) up to 375,000
shares of common stock and ii) up to 1,125,000
options to purchase shares of common stock. As
of March 31, 2023, there were 25,000
shares of common stock available for issuance
under the Nexcella 2022 Plan and 1,125,000 options to purchase shares of common stock as no stock options have been issued pursuant to
the Nexcella 2022 Plan as of March 31, 2023.
During
the three months ended March 31, 2023, Nexcella closed on its private offering for the sale of 100,152
common shares of Nexcella at a purchase price of $6.49
per share for total proceeds of $650,000.
The Company’s Chief Executive Officer purchased 7,704 shares of Nexcella’s common stock for a purchase price of $50,000
in the private placement offering. In addition, the Company’s Chief Financial Officer through Alwaysraise, LLC and Alwaysraise
Ventures I, L.P., entities affiliated with the Company’s Chief Financial Officer, purchased an aggregate of 15,408 shares of
Nexcella’s common stock in the private placement offering for $100,000. As of December 31, 2022, Nexcella entered into
subscription agreements for the sale of 73,188
shares of Nexcella’s common stock, at a purchase price of $6.49
per share for total proceeds of $475,000.
As of December 31, 2022, the offering had not yet closed, and the shares were not issued by Nexcella as of December 31, 2022, and
accordingly, the Company recorded the proceeds of $475,000
in funds held for subsidiary private offering at December 31, 2022.
On
December 8, 2022, Nexcella issued 350,000 shares of Nexcella restricted common stock to the officers of the Company for services to be
performed, which vest in 48 equal monthly installments. The stock was valued at a share price of $6.49 on the date of issuance, which
represents the most recent cash sales price of Nexcella’s common stock, for a total value of $2,271,500 related to services. During
the three months ended March 31, 2023, the Company recorded stock-based compensation expense of $141,969 related to the total value,
which was included in general and administrative expenses. The unrecognized stock-based compensation expense of $2,082,208 related to
unvested restricted common stock is expected to be recognized over the remaining vesting period of 3.69 years. As of March 31, 2023,
21,876 shares of the restricted common stock have vested with the remaining 328,124 restricted shares to vest over the vesting period
of 3.69 years.
On
March 13, 2023, pursuant to the terms of the Founders Agreement, Nexcella issued 167,566
shares of common stock to the Company as a PIK
Dividend based on the total dilutive shares of Nexcella outstanding as of March 12, 2023.
Note
5 – Licenses Acquired
On
December 8, 2022, Nexcella entered into a Research and License agreement with HADASIT and BIRAD (collectively, the “Licensors”)
to acquire intellectual property rights pertaining to CAR-T (the “H&B License”). Pursuant to the H&B License, Nexcella
paid the Licensors an upfront license fee of $1.5 million in December 2022 (included in research and development expenses on the consolidated
statements of operations and comprehensive loss). Additional quarterly payments totaling approximately $13 million related to the Company’s
ongoing support of the CAR-T clinical trials currently ongoing at HADASIT, are due through September 2026, along with an annual license
fee of $50,000. Future royalty payments of 5% are due on net sales of licensed products, combined with sales milestone payments in the
aggregate amount of up to $20 million when annual net sales reach certain thresholds for each licensed product. The royalties for each
licensed product on a country-to-country basis are to be paid through the latter of (a) the expiration of the last-to-expire valid claim
under a licensed patent (if any) in such country; (b) the date of expiration of any other Exclusivity Right (as defined in the H&B
License) or data protection period granted by a regulatory or other governmental authority with respect to a licensed product that provides
exclusivity in the relevant country; or (c) the end of a period of 15 years from the date of the First Commercial Sale (as defined in
the H&B License) of the applicable Licensed Product (as defined in the H&B License) in such country.
During
the three months ended March 31, 2023, the Company recorded R&D expenses of $630,963 related to the license agreement.
Note
6 – Commitments and Contingencies
Indemnifications
In
the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties
and may provide for indemnification of the counterparty. The Company’s exposure under these agreements is unknown because it involves
claims that may be made against it in the future but have not yet been made. To date, the Company has not been subject to any claims
or been required to defend any action related to its indemnification obligations.
The
Company indemnifies each of its directors and officers for certain events or occurrences, subject to certain limits, while the director
is or was serving at the Company’s request in such capacity, as permitted under Delaware law and in accordance with its certificate
of incorporation and bylaws. The term of the indemnification period lasts as long as the director or officer may be subject to any proceeding
arising out of acts or omissions of such individual in such capacity. The maximum amount of potential future indemnification is unlimited.
The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized
any liabilities relating to these obligations as of March 31, 2023.
Royalty
Agreement
On
December 22, 2014, the Company entered into a Master Service Agreement (“MSA”) with AxioMx, Inc. (“AxioMx”).
AxioMx is in the business of developing and supplying custom affinity reagents. AxioMx and the Company entered into the MSA to serve
as a master agreement governing multiple sets of projects as may be agreed upon by them from time to time. Pursuant to the MSA, AxioMx
is entitled to royalties on the sale of any Deliverable (as defined in the MSA) that is used for diagnostic, prognostic or therapeutic
purposes, in humans or animals, or for microbiology testing, including food safety testing or environmental monitoring. Specifically,
the Company shall pay AxioMx a royalty of 3.5% of Net Sales (as defined in the MSA) of assigned products for each Deliverable used in
licensed products for therapeutic purposes. In addition, the Company shall pay AxioMx a royalty of 1.5% of Net Sales of assigned products
for each Deliverable used in licensed products for diagnostic or prognostic purposes; provided, however, if three Deliverables are used
in an assigned product for diagnostic or prognostic purposes, the royalty shall be 4.5%. Through March 31, 2023, no amounts have been
paid or accrued under the MSA. As of December 31, 2022, the MSA has expired and the Company does not intend
to extend the MSA; however, the royalty obligations shall survive the termination of the MSA.
Legal
Proceedings
From
time to time the Company may be involved in claims that arise during the ordinary course of business. Although the results of litigation
and claims cannot be predicted with certainty, the Company does not currently have any pending litigation to which it is a party or to
which its property is subject that it believes to be material. Regardless of the outcome, litigation can be costly and time consuming,
and it can divert management’s attention from important business matters and initiatives, negatively impacting the Company’s
overall operations.
Employment
Agreements
On
June 18, 2021, the Company entered into an Employment Agreement with Ilya Rachman (as amended, the “Rachman Employment
Agreement”), effective for a three-year term. Pursuant to the Rachman Employment Agreement, the Company employs Dr. Rachman as
Chief Executive Officer and Dr. Rachman was entitled to a base salary of $360,000
annually. Dr. Rachman was also entitled to a performance-based bonus of 100%
of the base salary (subject to, and determined by, the Board in its sole discretion) plus additional performance bonuses to be
determined by the Board. On July 14, 2022, the Compensation Committee of the Board of Directors approved a new compensation package
for Dr. Rachman, and on November 9, 2022, the Company entered into an amendment to the Rachman Employment Agreement dated as of June
18, 2021 pursuant to which (i) Dr. Rachman’s annual base salary was increased to $425,000,
retroactive as of January 1, 2022 and (ii) entitling Dr. Rachman to a performance-based bonus of up to 50%
of his base salary (subject to, and determined by, the Board in its sole discretion) plus additional performance bonuses to be
determined by the Board. In addition, on July 14, 2022, the Company issued Dr. Rachman options to purchase up to 250,000
shares of the Company’s common stock at an exercise price of $2.64
per share. Unless terminated by the Company without “cause” or by Dr. Rachman with “good reason” (as such
terms are defined in the Rachman Employment Agreement), upon termination, Dr. Rachman will be entitled only to his base salary
through the date of termination, valid expense reimbursements and unused vacation pay. If terminated by the Company without
“cause” or by Dr. Rachman with “good reason,” he is entitled to be paid his base salary through the end of
the term at the rate of 150%,
valid expense reimbursements and accrued but unused vacation pay. On March 7, 2023, the Compensation Committee of the Board of
Directors approved an increase in the annual base salary and on May 12, 2023, the Company entered into an amendment to the Rachman Employment Agreement pursuant to which Dr. Rachman’s annual base salary was increased to $446,000, effective January 1, 2023. Dr. Rachman’s
employment agreement contains provisions for the protection of the Company’s intellectual property and contains non-compete
restrictions in the event of his termination other than by the Company without “cause” or by Dr. Rachman with
“good reason” (generally imposing restrictions on (i)
employment or consultation with competing companies or customers, (ii) recruiting or hiring employees for a competing company and
(iii) soliciting or accepting business from our customers for a period of six months following termination). Pursuant to the
Rachman Employment Agreement, Dr. Rachman may serve as a consultant to, or on boards of directors of, or in any other capacity to
other companies provided that they will not interfere with the performance of his duties to the Company.
On
March 18, 2021, the Company entered into a Management Services Agreement with Alwaysraise LLC, an entity which Gabriel Morris, the
Company’s Chief Financial Officer and a member of the Board, is sole member, effective for a three-year term, which was
amended effective June 18, 2021 (as amended, the “Morris MSA”). Pursuant to the Morris MSA, the Company employs Mr.
Morris as Chief Financial Officer and Mr. Morris was entitled to a base salary of $240,000
annually beginning in December 2021 ($120,000
annually prior). Mr. Morris was also entitled to a performance-based bonus of 100%
of the base salary (subject to, and determined by, the Board in its sole discretion) plus additional performance bonuses to be
determined by the Board. On July 14, 2022, the Compensation Committee of the Board of Directors approved a new compensation package
for Mr. Morris, and on November 9, 2022, the Company entered into an amendment to the Morris MSA dated as of March 24, 2021 pursuant
to which (i) Mr. Morris’ annual base salary was increased to $425,000,
retroactive as of January 1, 2022 and (ii) entitling Mr. Morris to a performance-based bonus of up to 50%
of his base salary (subject to, and determined by, the Board in its sole discretion) plus additional performance bonuses to be
determined by the Board. In addition, on July 14, 2022, the company issued Mr. Morris options to purchase up to 250,000
shares of the Company’s common stock at an exercise price of $2.64
per share. Unless terminated by the Company without “cause” or by Alwaysraise LLC (as such terms are defined in the
Morris MSA), upon termination, Mr. Morris will be entitled only to his base salary through the date of termination, valid expense
reimbursements and unused vacation pay. If terminated by the Company without “cause,” he is entitled to be paid his base
salary through the end of the term at the rate of 150%,
valid expense reimbursements and accrued but unused vacation pay. On March 7, 2023, the Compensation Committee of the Board of
Directors approved an increase in the annual base salary, and on May 12, 2023, the Company entered into an amendment to the Morris
MSA pursuant to which the Mr. Morris’ annual base salary was increased to $446,000, effective January 1, 2023. The Morris MSA
contains provisions for the protection of the Company’s intellectual property and confidential information.
On
June 24, 2021, the Company issued an offer letter to Graham Ross Oncology Consulting Services Ltd., a United Kingdom company, of which
Graham Ross, the Company’s consulting Acting Chief Medical Officer and Head of Clinical Development is the sole member, regarding
Dr. Ross’ provision of consultative services to the Company (the “Offer Letter”). Pursuant to the Offer Letter (signed
by Dr. Ross on June 24, 2021), Dr. Ross is entitled to an hourly rate for his consulting services and an option grant. On June 24, 2021,
the Company also signed a mutual confidentiality and non-disclosure agreement with Graham Ross Oncology Consulting Services Ltd.
Collaboration
Agreement
In
August 2021, the Company entered into a Clinical Collaboration and Supply Agreement with BeiGene Ltd. (“BeiGene”) for a combination
Phase 1b clinical trial in solid tumors of IMX-110 and anti-PD-1 Tislelizumab (the subject of a collaboration and license agreement among
BeiGene and Novartis). Under the terms of the agreement, the Company will conduct the combination trial. The cost of Tislelizumab manufacture
and supply (including shipping, taxes and duty if applicable and any third-party license payments that may be due) will be solely borne
by BeiGene. To date, no amounts have been paid to BeiGene.
Note
7 – Subsequent Events
Subsequent
events have been evaluated subsequent to the consolidated balance sheet date of March 31, 2023 through the filing date of this Quarterly
Report. Based on management’s evaluation, there are no other events that required recognition or disclosure, other than those discussed
below and elsewhere in the notes hereto.
Subsequent
to March 31, 2023, the Company sold a total of 1,084,281
shares of its common stock under the ATM Facility for aggregate net proceeds of $2,507,928.