Item 8. Financial Statements and Supplementary Data
ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
IMMIX
BIOPHARMA, INC.
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Audited
Consolidated Financial Statements for the Years Ended December 31, 2024 and 2023:
Report
of Independent Registered Public Accounting Firm – Crowe LLP (PCAOB ID: 173 )
F-2
Report of
Independent Registered Public Accounting Firm – KML Corbin & Company LLP (PCAOB ID: 170 )
F-3
Consolidated Balance Sheets as of December 31, 2024 and 2023
F-4
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2024 and 2023
F-5
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2024 and 2023
F-6
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023
F-7
Notes to the Consolidated Financial Statements for the Years Ended December 31, 2024 and 2023
F-8
F- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Shareholders
and the Board of Directors of Immix Biopharma, Inc.
Irvine,
California
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheet of Immix Biopharma, Inc. (the “Company”) as of December 31, 2024,
the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows, and the related
notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly,
in all material respects, the financial position of the Company as of December 31, 2024, and the results of its operations and its cash
flows for the year then ended, in conformity with accounting principles generally accepted in the United States of America.
The
financial statements of the Company as of December 31, 2023, were audited by other auditors whose report dated March 29, 2024, expressed
an unqualified opinion on those statements
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit
we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or
fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provided
a reasonable basis for our opinion.
/s/
Crowe LLP
We
have served as the Company’s auditor since 2024.
Los
Angeles, California
March
24, 2025
F- 2
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Stockholders and Board of Directors
Immix Biopharma, Inc.
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheet of Immix Biopharma, Inc. and its subsidiaries (the “Company”) as
of December 31, 2023, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash
flows for the year then ended, and the related notes (collectively referred to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position
of the Company as of December 31, 2023, and the results of its operations and its cash flows for the year then ended, in conformity
with accounting principles generally accepted in the United States of America.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on these consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting
Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with
the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due
to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audit provides a reasonable basis for our opinion.
KMJ
Corbin & Company LLP
We
served as the Company’s auditor from 2021 to 2024.
Glendora,
California
March 29, 2024
F- 3
Immix
Biopharma, Inc.
Consolidated
Balance Sheets
December 31, 2024
December 31, 2023
ASSETS
Current assets:
Cash and cash equivalents
$ 17,681,954
$ 17,509,791
Tax receivable
1,974,370
1,172,183
Prepaid expenses and other current assets
541,510
1,105,776
Total current assets
20,197,834
19,787,750
Other assets
20,418
-
Deferred offering costs
-
87,229
Right-of-use asset, net
989,471
-
Property and equipment, net
1,740,149
50,181
Total assets
$ 22,947,872
$ 19,925,160
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses
$ 8,621,899
$ 3,721,783
Operating lease liabilities - current
65,219
-
Total current liabilities
8,687,118
3,721,783
Operating lease liabilities - long term
1,009,551
-
Total liabilities
9,696,669
3,721,783
Commitments and contingencies
-
-
Stockholders’ equity:
Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding
-
-
Common stock, $ 0.0001 par value; 200,000,000 shares authorized; 27,612,383 shares issued and 27,540,020 shares outstanding at December 31, 2024, and 19,994,719 shares issued and 19,922,356 shares outstanding at December 31, 2023
2,762
2,000
Additional paid-in capital
88,374,131
69,779,706
Accumulated other comprehensive income
( 1,056 )
134,666
Accumulated deficit
( 75,024,671 )
( 53,411,295 )
Treasury stock at cost, 72,363 shares as of December 31, 2024 and 2023
( 99,963 )
( 99,963 )
Total Immix Biopharma, Inc. stockholders’ equity
13,251,203
16,405,114
Non-controlling interests
-
( 201,737 )
Total stockholders’ equity
13,251,203
16,203,377
Total liabilities and stockholders’ equity
$ 22,947,872
$ 19,925,160
See
accompanying notes to the consolidated financial statements.
F- 4
Immix
Biopharma, Inc.
Consolidated
Statements of Operations and Comprehensive Loss
For the Years Ended December 31,
2024
2023
Operating expenses:
General and administrative expenses
$ 11,381,978
$ 7,406,082
Research and development
11,292,702
8,735,031
Total operating expenses
22,674,680
16,141,113
Loss from operations
( 22,674,680 )
( 16,141,113 )
Other income:
Interest income
1,017,354
572,006
Total other income
1,017,354
572,006
Loss before provision for income taxes
( 21,657,326 )
( 15,569,107 )
Provision for income taxes
41,037
26,415
Net loss
( 21,698,363 )
( 15,595,522 )
Net loss attributable to non-controlling interests
84,987
169,474
Net loss attributable to Immix Biopharma, Inc. common stockholders
( 21,613,376 )
( 15,426,048 )
Other comprehensive income (loss):
Foreign currency translation
( 135,722 )
47,645
Total other comprehensive income (loss)
( 135,722 )
47,645
Comprehensive loss
( 21,749,098 )
( 15,378,403 )
Less: comprehensive loss attributable to non-controlling interests
-
-
Comprehensive loss attributable to Immix Biopharma, Inc. common stockholders
$ ( 21,749,098 )
$ ( 15,378,403 )
Loss per common share - basic and diluted
$ ( 0.76 )
$ ( 0.89 )
Weighted average shares outstanding – basic and diluted
28,285,637
17,341,146
See
accompanying notes to the consolidated financial statements.
F- 5
Immix
Biopharma, Inc.
Consolidated
Statements of Stockholders’ Equity
For
the Years Ended December 31, 2024 and 2023
Stockholders of Immix Biopharma, Inc.
Common
Additional
Accumulated Other
Treasury
Non-
Total
Common
Stock
Paid-in
Comprehensive
Accumulated
Treasury
Stock
Controlling
Stockholders’
Shares
Amount
Capital
Income
Deficit
Shares
Amount
Interests
Equity
Balance December 31, 2022
13,964,485
$ 1,397
$ 51,156,597
$ 87,021
$ ( 37,985,247 )
( 72,363 )
$ ( 99,963 )
$ -
$ 13,159,805
Shares issued under ATM facilities for cash proceeds, net of offering costs
2,523,702
252
5,438,718
-
-
-
-
-
5,438,970
Shares and warrants issued under private placement for cash proceeds, net of offering costs
3,241,076
324
9,933,829
-
-
-
-
-
9,934,153
Shares issued for exercise of stock options
1,351
-
2,618
-
-
-
-
-
2,618
Nexcella shares issued for cash proceeds
-
-
650,000
-
-
-
-
-
650,000
Shares issued for services
264,105
27
622,396
-
-
-
-
-
622,423
Stock-based compensation
-
-
1,943,285
-
-
-
-
-
1,943,285
Non-controlling interests in subsidiary
-
-
32,263
-
-
-
-
( 32,263 )
-
Net loss
-
-
-
-
( 15,426,048 )
-
-
( 169,474 )
( 15,595,522 )
Foreign currency translation adjustment
-
-
-
47,645
-
-
-
-
47,645
Balance December 31, 2023
19,994,719
$ 2,000
$ 69,779,706
$ 134,666
$ ( 53,411,295 )
( 72,363 )
$ ( 99,963 )
$ ( 201,737 )
$ 16,203,377
Balance
19,994,719
$ 2,000
$ 69,779,706
$ 134,666
$ ( 53,411,295 )
( 72,363 )
$ ( 99,963 )
$ ( 201,737 )
$ 16,203,377
Shares issued under ATM facility for cash proceeds, net of offering costs
68,302
7
338,488
-
-
-
-
-
338,495
Shares issued under public offering for cash proceeds, net of offering costs
6,319,025
632
15,519,722
-
-
-
-
-
15,520,354
Shares issued for exercise of stock options
1,251
-
2,489
-
-
-
-
-
2,489
Shares issued for services
239,210
24
627,352
-
-
-
-
-
627,376
Stock-based compensation
-
-
2,393,197
-
-
-
-
-
2,393,197
Non-controlling interests in subsidiary
-
-
29,672
-
-
-
-
( 29,672 )
-
Buyout of non-controlling interests in subsidiary
989,876
99
( 316,495 )
-
-
-
-
316,396
-
Net loss
-
-
-
-
( 21,613,376 )
-
-
( 84,987 )
( 21,698,363 )
Foreign currency translation adjustment
-
-
-
( 135,722 )
-
-
-
-
( 135,722 )
Balance December 31, 2024
27,612,383
$ 2,762
$ 88,374,131
$ ( 1,056 )
$ ( 75,024,671 )
( 72,363 )
$ ( 99,963 )
$ -
$ 13,251,203
Balance
27,612,383
$ 2,762
$ 88,374,131
$ ( 1,056 )
$ ( 75,024,671 )
( 72,363 )
$ ( 99,963 )
$ -
$ 13,251,203
See
accompanying notes to the consolidated financial statements.
F- 6
Immix
Biopharma, Inc.
Consolidated
Statements of Cash Flows
For the Years Ended December 31,
2024
2023
Operating Activities:
Net loss
$ ( 21,698,363 )
$ ( 15,595,522 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
3,020,573
2,565,708
Depreciation
32,941
5,468
Amortization of right of use asset
82,447
-
Changes in operating assets and liabilities:
Tax receivable
( 971,527 )
( 893,401 )
Prepaid expenses and other current assets
554,770
111,842
Other assets
( 20,418 )
-
Accounts payable and accrued expenses
4,401,623
2,434,467
Operating lease liability
2,852
-
Net cash used in operating activities
( 14,595,102 )
( 11,371,438 )
Investing Activities:
Purchase of property and equipment
( 1,177,680 )
( 52,089 )
Net cash used in investing activities
( 1,177,680 )
( 52,089 )
Financing Activities:
Payments of deferred offering costs
-
( 234,616 )
Proceeds from exercise of stock options
2,489
2,618
Proceeds from sale of common stock, net of offering costs
15,946,078
15,520,510
Proceeds from sale of Nexcella common stock
-
175,000
Net cash provided by financing activities
15,948,567
15,463,512
Effect of foreign currency on cash
( 3,622 )
33,092
Net change in cash and cash equivalents
172,163
4,073,077
Cash and cash equivalents - beginning of year
17,509,791
13,436,714
Cash and cash equivalents - end of year
$ 17,681,964
$ 17,509,791
Supplemental Disclosures of Cash Flow Information:
Interest paid
$ -
$ -
Income taxes paid
$ -
$ -
Supplemental Disclosures of Noncash Financing Information:
Establishment of right of use asset and liabilities
$ 1,071,918
$ -
Purchases of property and equipment included in accounts payable and accrued liabilities
$ 545,229
$ -
Nexcella shares issued for funds previously received
$ -
$ 475,000
Shares issues in subsidiary absorption
$ 99
$ -
Deferred offering costs charged against proceeds from sale of common stock
$ 87,229
$ 147,387
See
accompanying notes to the consolidated financial statements.
F- 7
Immix
Biopharma, Inc.
Notes
to the Consolidated Financial Statements
Note
1 – Nature of Business
Immix
Biopharma, Inc. (the “Company”) is a clinical-stage biopharmaceutical pharmaceutical company organized as a Delaware corporation
on January 7, 2014, which is focused on developing cell therapies in AL Amyloidosis and select immune-mediated 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. (“Nexcella”), its cell therapy division, which subsequently merged into the Company in May 2024,
with the Company continuing as the surviving entity.
Note
2 – Summary of Significant Accounting Policies
The
accompanying 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.
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 was denied approval, approval
was delayed or the Company was 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.
F- 8
Use
of Estimates in Financial Statement Presentation - The preparation of these 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
judgments 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 consolidated financial statements include the accounts of Immix Biopharma, Inc., the accounts
of its 100 % owned subsidiary, IBAPL, and the accounts of its and the accounts of its subsidiary Nexcella, which was majority owned through
May 2024, and wholly-owned after May 2024, as discussed above. 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 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.
Segment
Reporting - The Company manages its operations as a single segment for the purposes of assessing performance and making operating
decisions. The Company’s Chief Operating Decision Maker (“CODM”) is its Chief Executive Officer. The CODM allocates
resources and evaluates the performance of the Company at the consolidated level using information about its revenues, gross profit,
income from operations, and other key financial data. All significant operating decisions are based upon an analysis of the Company as
one operating segment, which is the same as its reporting segment.
Liquidity
and Going Concern - These 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. Since the initial public offering
of its common stock in December 2021, the Company has financed its operations through various equity financing. On July 14, 2023, the
Company entered into an ATM Sales Agreement (the “July 2023 Sales Agreement”) with ThinkEquity LLC (the “Sales Agent”),
pursuant to which the Company, could, from time to time, issue and sell through the Sales Agent 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 “July 2023 ATM Facility”) (see Note 7). Initially, the Company was eligible to sell up to $ 4,200,000
worth of shares of its common stock as the aggregate market value of the Company’s shares of common stock eligible for sale under
the July 2023 Sales Agreement is subject to the limitations of General Instruction I.B.6 of Form S-3 until such time that the Company’s
public float equals or exceeds $ 75.0 million. In the event the aggregate market value of the Company’s outstanding common stock
held by non-affiliates equals or exceeds $ 75.0 million, then the one-third limitation on sales set forth in General Instruction I.B.6
of Form S-3 shall not apply to additional sales made pursuant to the July 2023 Sales Agreement.
From
July 14, 2023 through February 5, 2024, the Company sold 328,136 common shares pursuant to the July 2023 ATM Facility for net proceeds
of $ 1,091,887 , after offering expenses. On February 5, 2024, the Company suspended, and is not offering any shares of its common stock
pursuant to, the prospectus supplement dated July 14, 2023, relating to the July 2023 Sales Agreement by and between the Company and
the Sales Agent. The Company will not make any sales of common stock pursuant to the July 2023 Sales Agreement unless and until a new
prospectus supplement is filed with the SEC; however, the July 2023 Sales Agreement remains in full force and effect.
In
February 2024, the Company conducted an underwritten public offering of 5,535,055 shares of its common stock at the public offering price
of $ 2.71 per share, for the net proceeds of $ 13,565,760 , after underwriter discounts and offering expenses (the “Offering”).
Pursuant to the underwriting agreement, the Company granted the underwriter a 30-day over-allotment option to purchase up to an additional
783,970 shares of the Company’s common stock, which was exercised in full on March 1, 2024 for net proceeds of $ 1,954,594 , after
underwriting discounts and offering expenses (see Note 7).
On
July 25, 2024, the Company was awarded an $ 8 million grant from the California Institute for Regenerative Medicine (CIRM) to support
the clinical development of chimeric antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.
The award is payable to the Company upon achievement of milestones that are primarily based on patient enrollment in the Company’s
clinical trials. Additionally, if CIRM determines, in its sole discretion, that the Company has not complied with the terms and conditions
of the grant, CIRM may suspend or permanently cease disbursements. Funds received under this grant may only be used for allowable project
costs specifically identified with the CIRM-funded project. Such costs can include, but are not limited to, salary for personnel, itemized
supplies, consultants, and itemized clinical study costs. Under the terms of the grant, both CIRM and the Company will co-fund the research
project and the amount of the Company’s co-funding requirement is predetermined as a part of the award. The Company signed the
grant agreement in November 2024 and began receiving funds from the grant in November of 2024.
F- 9
The
Company has a history of, and expects to continue to report, negative cash flows from operations and net losses. We believe that our
existing cash, cash equivalents and restricted cash as of December 31, 2024, expected disbursements under the CIRM grant, and expected
payments of tax receivables will enable us to fund our operating expenses and capital expenditure requirements for at least the next
12 months from the filing of our 10-K.
Concentration
of Credit Risk - Periodically, the Company may carry cash and cash equivalents balances at financial institutions in excess of the
United States federally insured limit of $ 250,000 , or the Australian insured limit of AUD 250,000 . At times, deposits held with financial
institutions may exceed the amount of insurance provided. 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 table 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 December 31, 2024
Level 1
Level 2
Level 3
Assets:
Cash equivalents (money market funds)
$ 8,208,776
$ -
$ -
Cash equivalents (US Treasuries)
7,220,655
$ -
$ -
Total
$ 15,429,431
$ -
$ -
Level 1
Level 2
Level 3
Fair Value Measurements at December 31, 2023
Level 1
Level 2
Level 3
Assets:
Cash equivalents (money market funds)
$ 16,113,006
$ -
$ -
Cash equivalents
$ 16,113,006
$ -
$ -
As
of December 31, 2024 and 2023, the Company had no liabilities required to be measured at fair value on a recurring basis.
F- 10
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 $ 1,299,616
and $ 1,064,745
for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024 and 2023, the Company recognized a tax receivable related to the expected cash refund from
the Australian Taxation Office of $ 1,974,370 and $ 1,172,183 , respectively, in the accompanying consolidated balance sheets.
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 July 2023 ATM Facility. Deferred offering costs will be deferred and amortized
ratably upon sales under the July 2023 ATM Facility, and upon completion, they will be reclassified to additional paid-in capital as
a reduction of the July ATM proceeds. If the Company terminates the July 2023 ATM Facility or there is a significant delay, all of the
deferred offering costs will be immediately written off to operating expenses. As of December 31, 2024, no remaining amounts of deferred
offering costs were capitalized related to the July 2023 ATM Facility. As of December 31, 2023, $ 87,229 of deferred offering costs were
capitalized related to the July 2023 ATM Facility.
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 7). 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 – Research and development costs are expensed as incurred. Research and development 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. Research
and development costs also include grant reimbursements under government contracts. Costs incurred in obtaining technology licenses are
charged to research and development 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 research and development 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 consolidated
balance sheets, as accumulated other comprehensive income.
Foreign
Currency Translation and Transaction Gains (Losses) – The Company and Nexcella, its majority-owned subsidiary through May 2024,
and wholly-owned subsidiary thereafter maintain their accounting records in U.S. Dollars. The Company’s operating wholly-owned
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. Exchange gains and (losses) are recognized in income and were $ ( 39,600 ) and $ ( 992 ) for the years ended December 31,
2024 and 2023, respectively, and are included in general and administrative expenses in the accompanying consolidated statements of operations
and comprehensive loss.
F- 11
Loss
Per Common Share - Basic loss per common share is computed by dividing net loss attributable 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. Basic weighted average shares outstanding for the year ended December 31, 2024 include 1,913,661 shares underlying
Pre-Funded warrants to purchase common shares. As the shares underlying these Pre-Funded warrants can be issued for little consideration
(an exercise price per share equal to $ 0.0001 per share), these shares are deemed to be issued for purposes of basic loss per common
share. As of December 31, 2024 and 2023, the Company’s potentially dilutive shares and options, which were not included in the
calculation of net loss per share, included stock options and warrants for 4,463,488 and 2,910,061 common shares, respectively.
Property
and Equipment - Included in property and equipment is construction-in-progress which consists of manufacturing space improvements
and includes the costs of construction, machinery and equipment, and any interest charges arising from borrowings used to finance these
assets during the period of construction or installation of the assets. No provision for depreciation is made on construction-in-progress
until such time as the relevant assets are completed and ready for their intended use.
Estimated
useful lives of the Company’s assets are as follows:
Schedule
of Property and Equipment Useful Lives
Useful
Life
Operating equipment
3 - 10 years
Electronic equipment
3 - 5 years
Office equipment
3 - 5 years
The
cost and related accumulated depreciation of assets sold or otherwise retired are eliminated from the accounts, and any gain or loss
are included in the Company’s results of operations. The costs of maintenance and repairs are recognized to expenses as incurred;
significant renewals and betterments are capitalized.
Leases
- At the inception of a contract the Company determines if the arrangement is, or contains a lease. Operating lease right-of-use
(“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent
its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement
date based on the present value of the lease payments over the lease term. Lease expense is recognized on a straight-line basis over
the lease term.
The
Company has made certain accounting policy elections whereby it (i) does not recognize ROU assets or lease liabilities for short-term
leases (those with original terms of 12-months or less) and (ii) separates lease and non-lease elements of its operating leases as separate
lease components. As of December 31, 2024 and 2023, the Company did not have any finance leases.
Impairment
of Long-lived Assets – The Company evaluates its long-lived assets for impairment whenever events or changes in circumstances
indicate that the carrying amount of such assets may not be recoverable. Recoverability of a long-lived asset is measured by comparison
of the carrying amount to the expected future undiscounted cash flows that the asset is expected to generate. Any impairment to be recognized
is measured by the amount by which the carrying amount of the asset exceeds its fair value.
Income
Taxes – The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets
and liabilities are determined based on the differences between the financial reporting and the tax bases of reported assets and liabilities
and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company
must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is
more likely than not that some portion or all of a deferred tax asset will not be realized.
F- 12
The
Company accounts for uncertain tax positions in accordance with the provisions of Accounting Standards Codification (ASC) 740-10 which
prescribes a recognition threshold and measurement attribute for financial statement disclosure of tax positions taken, or expected to
be taken, on its tax return. The Company evaluates and records any uncertain tax positions based on the amount that management deems
is more likely than not to be sustained upon examination and ultimate settlement with the tax authorities in the tax jurisdictions in
which it operates.
Patent
Costs – Although the Company believes that its patents have continuing value, the amount of future benefits to be derived from
the patents is uncertain. Accordingly, patent costs are expensed as incurred.
Advertising
Costs – The Company expenses advertising costs as incurred. Advertising costs were not significant during the years ended December
31, 2024 and 2023.
Grant
Income – The Company records grant income when both the following conditions are met; all terms and conditions for disbursement
milestones have been met and the related co-funding disbursement is probable. Grant income is presented as a separate component of other
income (expense).
Emerging
Growth Company Status - The Company is an “emerging growth company” (“EGC”) as defined in the Jumpstart Our
Business Startups Act (the “JOBS Act”), and may take advantage of certain exemptions from various reporting requirements
that are applicable to other public companies that are not EGCs. The Company may take advantage of these exemptions until it is no longer
an EGC under Section 107 of the JOBS Act and has elected to use the extended transition period for complying with new or revised accounting
standards. As a result of this election, the Company’s financial statements may not be comparable to companies that comply with
public company Financial Accounting Standards Board (“FASB”) standards’ effective dates. The Company may take advantage
of these exemptions up until it is no longer an EGC.
Recent
Accounting Pronouncements – In November 2023, the FASB issued ASU 2023-07 , Segment Reporting ( Topic 280 ) :
Improvements to Reportable Segment Disclosures, which requires disclosure of incremental segment information on an annual and
interim basis. This Accounting Standards Update (ASU) is effective for fiscal years beginning after December 15, 2023, and interim periods
within fiscal years beginning after December 15, 2024 on a retrospective basis. The Company has implemented this ASU effective January
1, 2024, and determined no retrospective changes were necessary.
In
December 2023, the FASB issued ASU 2023-09 , Income Taxes ( Topic 740 ) : Improvements to Income Tax Disclosures,
which expands the disclosures required for income taxes. This ASU is effective for fiscal years beginning after December 15, 2024,
with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The
Company is currently evaluating the effect of this pronouncement on its disclosures.
Note
3 – Prior Agreements with Nexcella Subsidiary
Nexcella
Absorption
On
May 20, 2024, Nexcella, was merged (the “Merger”) with and into the Company, with the Company as the surviving corporation
(the “Nexcella Absorption”). The Merger was effected pursuant to Section 253 of the Delaware General Corporation Law (“DGCL”)
when the Company filed a Certificate of Ownership and Merger (“Certificate of Merger”) with the Secretary of State of the
State of Delaware. Immediately prior to the Merger, the Company owned greater than 95 % of the outstanding common stock on a fully diluted
basis of Nexcella, par value $ 0.0001 per share (the “Nexcella Shares”), and 100 % of the outstanding shares of each other
class of capital stock of Nexcella. Under the DGCL, the only approval required was that of the Company’s Board of Directors for
the Merger to become effective. As a result of the Merger, Nexcella ceased to exist and all assets, operations and other property and
rights of Nexcella have been succeeded to by the Company. Pursuant to the terms of the Certificate of Merger, as a result of the Merger,
each of the outstanding Nexcella Shares (other than Nexcella Shares held by the Company) were converted into common stock of the Company
(“Company Merger Shares”). In connection with the Merger, the Company issued 989,876 shares of its common stock to the former
stockholders of Nexcella (other than shares held by the Company) (including Company common stock issued to third-party cash investors
in Nexcella) (the “Merger Shares”). The shares were issued on a pro-rata basis and as such resulted in no change in fair
value. In addition, the Company issued to the former participants in the Nexcella 2022 Equity Incentive Plan, 275,759 restricted stock
awards to receive common stock in the Company and options to purchase up to 595,676 shares of Company common stock at an exercise price
of $ 2.47 per share (the closing price on May 17, 2024), under the Company’s Amended and Restated 2021 Omnibus Equity Incentive
Plan. As such, as of May 20, 2024, the Founders Agreement and Management Services Agreement agreements listed below with Nexcella are
no longer in effect.
F- 13
Founders
Agreement
Effective
December 8, 2022, the Company entered into a Founders Agreement with Nexcella (the “Nexcella Founders Agreement”).
The
Nexcella Founders Agreement provided 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 Medical 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 had a maturity date of January 31, 2030 , accrued interest at a rate of 7.875 %
per annum and was 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 note and accrued
interest were converted in full prior to the Nexcella Absorption. The Nexcella Founders Agreement had a term of 15 years, which, upon
expiration, would automatically renew 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 was identical
to the common stock other than as to conversion rights, the PIK Dividend right (as defined below) and voting rights.
Each
share of Class A Preferred Stock was 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 received on each March
13 (each a “PIK Dividend Payment Date”) until the date all outstanding Class A Preferred Stock was 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 was equal to 2.5 % of Nexcella’s fully-diluted outstanding capitalization on the date that was one business
day prior to any PIK Dividend Payment Date. In addition, as a holder of Class A Preferred Stock, the Company was 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 was equal to 1.1 times a fraction, the numerator of which was 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 were convertible and the denominator of which was the number of shares of outstanding
Nexcella Class A Preferred Stock.
F- 14
Each
share of Class A Common Stock was 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 in the Nexcella COI) or Qualified Change
in Control (as defined in the Nexcella COI), each share of Class A Common Stock would 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 was 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 would 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 on 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 was 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 was 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 was 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 also agreed to: (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 agreed to 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 rendered 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 utilized 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 paid the Company an annual base management and consulting fee of $ 500,000 (the “Annual Consulting Fee”).
Notwithstanding the foregoing, the first Annual Consulting Fee payment was not due until the first business day of the calendar quarter
immediately following the completion of the first equity financing for Nexcella that was in excess of $ 10 million in gross proceeds,
which did not occur. Actual and direct out-of-pocket expenses reasonably incurred by the Company in performing the Services were reimbursed
to the Company by Nexcella.
The
Nexcella MSA was terminated on May 20, 2024 in connection with the Nexcella Absorption. In addition, as a result of the Nexcella Absorption,
the Class A Preferred Stock, Class A Common Stock, and the Founders Agreement cease to exist.
F- 15
Note
4 – Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consist of the following as of December 31, 2024 and 2023:
Schedule of Prepaid Expenses and
Other Current Assets
December 31, 2024
December 31, 2023
Prepaid research and development expenses
$ 472,508
$ 412,773
Prepaid insurance expense
9,334
263,927
Prepaid investor relations expense
27,397
384,494
Other current assets
32,271
44,582
Total prepaid expenses and other current assets
$ 541,510
$ 1,105,776
Note
5 – Accounts Payable and Accrued Expenses
Accounts
payable and accrued expenses consist of the following as of December 31, 2024 and 2023:
Schedule
of Accounts Payable and Accrued Expenses
December 31, 2024
December 31, 2023
Accounts payable
$ 5,388,494
$ 1,433,022
Accrued research and development expenses
2,423,177
1,571,261
Accrued professional services
22,500
38,639
Accrued compensation and related expenses
658,161
577,854
Other accrued expenses
129,567
101,007
Total accounts payable and accrued expenses
$ 8,621,899
$ 3,721,783
Note
6 – Property and Equipment
Property
and equipment at December 31, 2024 and 2023 consisted of:
Schedule
of Property and Equipment
December 31, 2024
December 31, 2023
Operating equipment
$ 844,740
$ 60,599
Office equipment
3,896
3,896
Total property and equipment, gross
848,636
64,495
Less: Accumulated depreciation
( 47,255 )
( 14,314 )
Property and equipment
excluding construction in progress
801,381
50,181
Construction in progress
938,768
-
Total property and equipment
$ 1,740,149
$ 50,181
For
the years ended December 31, 2024 and 2023, depreciation expense amounted to $ 32,941 and $ 5,468 , respectively. Depreciation is not taken
during the period of construction or equipment installation. Upon completion of the installation of manufacturing equipment or any construction
in progress, balances will be classified to their respective property and equipment category.
The
construction in progress of $ 938,768 as of December 31, 2024, represents the investment in building a biopharmaceutical processing facility
inside the leased property. The Company expects to complete the processing facility by the end of 2025.
Note
7 – 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.
F- 16
July
2023 ATM Sales Agreement
On
July 14, 2023, the Company entered into the July 2023 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 “July Shares”) of the Company’s common stock, par value
$ 0.0001 per share, subject to the terms and conditions set forth in the July 2023 Sales Agreement. Initially, the Company is eligible
to sell up to $ 4,200,000 worth of shares of its common stock as the aggregate market value of the Company’s shares of common stock
eligible for sale under the July 2023 Sales Agreement is subject to the limitations of General Instruction I.B.6 of Form S-3 until such
time that the Company’s public float equals or exceeds $ 75.0 million. In the event the aggregate market value of the Company’s
outstanding common stock held by non-affiliates equals or exceeds $ 75.0 million, then the one-third limitation on sales set forth in
General Instruction I.B.6 of Form S-3 shall not apply to additional sales made pursuant to the July 2023 Sales Agreement. The July Shares
will be offered and sold pursuant to the Company’s prospectus supplement, dated July 14, 2023, filed by the Company with the SEC
on July 14, 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.
Under
the July 2023 Sales Agreement, the Sales Agent may sell the July Shares in sales deemed to be “at-the-market offerings” as
defined in Rule 415(a)(4) promulgated under 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 July 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 July Shares pursuant
to the July 2023 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 of 1933, as amended.
During
the year ended December 31, 2024, the Company sold a total of 68,302 shares of its common stock under the July 2023 ATM Facility for
aggregate net proceeds of $ 338,495 after deducting commissions and SEC fees, and charging $ 87,229 of deferred offering costs against
the proceeds. On February 5, 2024, the Company suspended, and is not offering any shares of its common stock pursuant to, the prospectus
supplement dated July 14, 2023, relating to the July 2023 Sales Agreement by and between the Company and ThinkEquity LLC. The Company
will not make any sales of common stock pursuant to the July 2023 Sales Agreement unless and until a new prospectus supplement is filed
with the SEC; however, the July 2023 Sales Agreement remains in full force and effect.
Common
Stock Issuance – Public Offering
On
February 5, 2024, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Titan Partners Group
LLC, a division of American Capital Partners, LLC (the “Underwriter”), relating to an underwritten offering (the “Offering”)
of 5,535,055 shares of common stock of the Company. The public offering price was $ 2.71 per share of common stock and the Underwriter
agreed to purchase the common stock pursuant to the Underwriting Agreement at a price of $ 2.5203 per share. On February 8, 2024, the
Company closed the offering and received net proceeds of $ 13,565,760 , after deducting underwriting discounts and commissions and estimated
offering expenses. Pursuant to the Agreement, the Company granted the Underwriter a 30-day over-allotment option to purchase up to an
additional 783,970 shares of common stock which was exercised in full on March 1, 2024, for net proceeds of $ 1,954,594 , after deducting
underwriting discounts and offering expenses.
Other
Common Stock Issuances
During
the year ended December 31, 2024, the Company issued 114,767 shares of restricted common stock valued at $ 270,000 for investor relations
services based on the average closing price for the prior 10 trading days pursuant to a marketing services agreement entered into on
July 25, 2023.
F- 17
During
the year ended December 31, 2024, the Company issued 124,443 shares of restricted common stock valued at $ 357,376 for investor relations
services based on the closing price pursuant to the extensions of marketing services agreements.
During
the year ended December 31, 2024, the Company issued 1,251 shares of common stock upon the exercise of certain common stock options for
cash proceeds of $ 2,489 .
During
the year ended December 31, 2023, the Company entered into various marketing services agreements, whereby the Company agreed to issue
122,300 shares of its common stock, valued at $ 247,500 , in exchange for future services. As of December 31, 2023, the Company has issued
122,300 shares of the Company’s common stock pursuant to the marketing services agreements. During the year ended December 31,
2023, the Company recorded stock-based compensation expense of $ 232,624 related to the fair value of the shares of common stock. As of
December 31, 2023, the Company has $ 14,876 of unamortized stock-based compensation which was amortized during the current period.
During
the year ended December 31, 2023, the Company entered into various marketing services agreements, whereby the Company issued 123,396
shares of its common stock valued at $ 322,299 for services received, which was recorded as stock-based compensation during the year ended
December 31, 2023.
During
the year ended December 31, 2023, the Company entered into a marketing services agreement, whereby the Company agreed to issue shares
of restricted common stock for services performed on a monthly basis valued at $ 22,500 based on the average closing price for the prior
10 trading days. During the year ended December 31, 2023, the Company has issued 18,409 shares of its common stock for an aggregate value
of $ 67,500 pursuant to the agreement.
During
the year ended December 31, 2023, the Company issued 1,351 shares of its common stock upon the exercise of stock options for cash proceeds
of $ 2,618 .
Restricted
Stock Awards
Pursuant
to the Merger, the Company issued to the former participants in the Nexcella 2022 Equity Incentive Plan, 275,759 restricted stock awards
to receive common stock in the Company. The shares were issued on a pro-rata basis and resulted in no change in fair value.
During
the year ended December 31, 2024, the Company recorded stock-based compensation expense of $ 438,671 related to the total fair value of
the previously issued restricted stock awards, which was included in general and administrative expenses. The unrecognized stock-based
compensation expense of $ 242,454 related to unvested restricted common stock is expected to be recognized over the remaining vesting
period of 0.37 years. As of December 31, 2024, 164,315 shares of restricted common stock have vested with the remaining 111,444 restricted
shares to vest over the vesting period of 0.37 years.
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 (as amended and restated, the “2021 Plan”) pursuant to which it initially reserved and made 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) would not count
against such share limit. Subsequent to September 10, 2021, no further awards are to 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.
F- 18
On
April 24, 2023, the Company’s Board of Directors adopted the Immix Biopharma, Inc. Amended and Restated 2021 Omnibus Equity Incentive
Plan (the “Amended 2021 Plan”) which, among other things, increased the number of shares of common stock that may be issued
under such plan by 1,034,561 shares, subject to stockholder approval. On June 7, 2023, stockholders of the Company approved the Amended
2021 Plan. On April 18, 2024, our Board of Directors approved amendments to the 2021 Plan (the “2 nd Amended 2021 Plan”)
to (i) increase the number of shares of common stock available for issuance under the 2021 Plan by 3,000,000 to a total share reserve
of 4,934,561 and (ii) the adoption of an evergreen provision to the 2021 Plan to provide for an automatic annual increase in the shares
of common stock available for issuance under the 2021 Plan over the next ten years (the “2021 Plan Amendments”). Pursuant
to the evergreen provision, the number of shares available for issuance under the 2021 Plan shall automatically increase on January 1st
of each year for a period of ten years, commencing on January 1, 2025 and ending on (and including) January 1, 2034, in an amount equal
to five percent ( 5 %) of the total number of shares of Common Stock outstanding on December 31st of the preceding calendar year. On June
11, 2024, stockholders of the Company approved the 2 nd Amended 2021 Plan. As of December 31, 2024, there were 2,210,757 shares
of the Company’s common stock remaining to be issued under the Amended 2021 Plan.
In
addition, the Company issued to the former participants in the Nexcella 2022 Equity Incentive Plan, options to purchase up to 595,676
shares of Company common stock at an exercise price of $ 2.47 per share (the closing price on May 17, 2024), under the Company’s
Amended and Restated 2021 Omnibus Equity Incentive Plan. The options were issued on a pro-rata basis and resulted in no change in fair
value.
During the year ended December 31, 2024, the Board of Directors approved the issuance of options to purchase 98,500 shares of the Company’s
common stock to employees of the Company, 198,000 to non-employee members of the Board of Directors of the Company
and 680,000 shares of the Company’s common stock to management of the Company. The options have a term of 10 years and exercise prices ranging from $ 1.48 - $ 2.17 per share, which options
vest in 48 equal monthly installments .
During
the year ended December 31, 2023, the Compensation Committee of the Board of Directors approved the issuance of options to purchase 136,670
shares of the Company’s common stock to non-employee members of the Board of Directors of the Company and 586,000 shares of the
Company’s common stock to management of the Company. The options have a term of 10 years, exercise prices ranging from $ 1.82 to
$ 1.95 per share and vest over periods of 10 to 48 equal monthly installments .
During
the year ended December 31, 2023, the Board of Directors approved the issuance of options to purchase 20,000 shares of the Company’s
common stock to a consultant of the Company with a term of 10 years and an exercise price of $ 1.95 per share, which options vest in 48
equal monthly installments .
The
following table reflects the weighted average assumptions used to estimate the fair value of stock options granted during the years ended
December 31, 2024 and 2023:
Schedule
of Stock Option Valuation Assumption
2024
2023
Volatility
98 - 107
%
114 - 120
%
Expected life (years)
5.27 - 6.02
5.27 - 10
Risk-free interest rate
3.56 - 4.64
%
4.12 - 4.38
%
Dividend rate
—
%
—
%
The
Company recognized stock-based compensation of $ 1,404,044 and $ 731,329 related to stock options for the years ended December 31, 2024
and 2023, respectively, which is included in general and administrative expenses.
As
of December 31, 2024, the Company had unrecognized stock-based compensation expense of $ 2,779,882 , related to unvested stock options,
which is expected to be recognized over the weighted-average vesting period of 2.51 years.
F- 19
The
following table summarizes the stock option activity for the years ended December 31, 2024 and 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
742,670
$ 1.86
Exercised
( 1,351 )
$ 1.94
Forfeited
-
$ -
Expired
-
$ -
Outstanding, December 31, 2023
2,512,561
$ 1.92
Granted
1,572,176
$ 2.19
Exercised
( 834 )
$ 1.95
Forfeited
( 17,915 )
$ 1.95
Expired
-
$ -
Outstanding and expected to vest, December 31, 2024
4,065,988
$ 2.02
The
following table discloses information regarding outstanding and exercisable options at December 31, 2024:
Schedule
of Stock Outstanding and Exercisable
Outstanding
Exercisable
Exercise Price Range
Number of
Option
Shares
Weighted
Average
Exercise Price
Weighted
Average
Remaining
Life (Years)
Number of
Option
Shares
Weighted
Average
Exercise Price
$ 0.00 - 1.00
256,500
$ 0.80
6.20
256,500
$ 0.80
$ 1.01 - 2.00
1,701,062
$ 1.80
6.97
1,149,704
$ 1.79
$ 2.01 - 3.00
2,097,176
$ 2.33
8.88
937,851
$ 2.45
$ 3.10 - 6.00
11,250
$ 5.83
7.04
8,203
$ 5.83
4,065,988
$ 2.02
7.91
2,352,258
$ 1.96
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 December 31, 2024, the intrinsic value for the options vested
and outstanding was $ 1,185,433 .
The
total intrinsic value of stock options exercised during the year ended December 31, 2024 was $ 3,069 .
F- 20
Stock
Warrants
The
following table summarizes the stock warrant activity for the years ended December 31, 2024 and 2023:
Schedule
of Stock Warrant Activity
Warrants
Weighted-Average
Exercise Price
Per Share
Outstanding and exercisable, January 1, 2023
397,500
$ 4.11
Granted
1,913,661
$ 0.0001
Exercised
-
$ -
Forfeited
-
$ -
Expired
-
$ -
Outstanding and exercisable, December 31, 2023
2,311,161
$ 0.71
Granted
-
$ -
Exercised
-
$ -
Forfeited
-
$ -
Expired
-
$ -
Outstanding and exercisable, December 31, 2024
2,311,161
$ 0.71
The
following table discloses information regarding outstanding and exercisable warrants at December 31, 2024:
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
$
0.0001
1,913,661
$
0.0001
-
1,913,661
$
0.0001
$
0.80
156,000
$
0.80
6.23
156,000
$
0.80
$
6.25
241,500
$
6.25
1.96
241,500
$
6.25
2,311,161
$
4.11
0.62
2,311,161
$
0.71
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 December 31, 2024, the intrinsic value for
the warrants vested and outstanding was $ 4,428,263 .
Nexcella
Equity Transactions
The
Nexcella 2022 Equity Incentive Plan (the “2022 Plan”) allows for Nexcella’s Board of Directors to grant various forms
of incentive awards initially covering up to 375,000 shares of common stock. On May 29, 2023, Nexcella’s Board of Directors approved
the Second Amended and Restated Nexcella 2022 Equity Incentive Plan, which increased to the number of shares of Nexcella common stock
issuable under the plan from 375,000 shares to 607,640 shares. On August 11, 2023, Nexcella’s Board of Directors requested the
Third Amended and Restated 2022 Equity Incentive Plan, which increased the number of shares of Nexcella common stock issuable under the
plan from 607,640 to 800,000 shares. The Nexcella shareholders subsequently approved the increase in Nexcella common stock issuable under
the plan to 800,000 shares. On May 17, 2024, upon absorption into the Company, the 2022 Plan ceased to exist.
As
of December 31, 2023, there were 83,688 shares of common stock available for issuance under the Nexcella 2022 Plan.
F- 21
Common
Stock
On
March 13, 2024, pursuant to the terms of the Founders Agreement, Nexcella issued 238,220 shares of common stock to the Company as a PIK
Dividend based on the total dilutive shares of Nexcella outstanding as of March 12, 2024.
During
the year ended December 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
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.
Restricted
Stock Awards
During
the year ended December 31, 2023, the Board of Directors of Nexcella, granted 179,784 shares of restricted common stock to the non-employee
members of the Board of Directors for services to be performed, which vest in 24 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 $ 1,166,798 related to services.
During
the year ended December 31, 2024, the Company recorded stock-based compensation expense of $ 402,163 related to the total fair value of the previously
issued restricted stock awards. Pursuant to the Merger, the Company issued to the former participants in the Nexcella 2022 Equity Incentive
Plan, 275,759 restricted stock awards to receive common stock in the Company. The shares were issued on a pro-rata basis and resulted
in no change in fair value. As a result, there was no remaining unvested stock-based compensation expense under Nexcella.
During
the year ended December 31, 2023, the Company recorded stock-based compensation expense of $ 950,672 , related to the total value, which
was included in general and administrative expenses.
Stock
Options
During
the year ended December 31, 2023, the Board of Directors of Nexcella, granted 114,028 options to purchase shares of common stock to the
non-employee members of the Board of Directors for services to be performed, with a term of 10 years and an exercise price of $ 6.49 per
share, which options vest in 24 equal monthly installments .
During
the year ended December 31, 2023, the Board of Directors of Nexcella granted 72,500 options to purchase shares of common stock to three
consultants for services to be performed, with a term of 10 years and an exercise price of $ 6.49 per share, which options vest in 48
equal monthly installments .
During
the year ended December 31, 2024, the Company recorded stock-based compensation expense of $ 148,319 related to the previously issued restricted
stock options. Pursuant to the Merger, the Company issued to the former participants in the Nexcella 2022 Equity Incentive Plan, options
to purchase up to 595,676 shares of Company common stock under the Company’s Amended and Restated 2021 Omnibus Equity Incentive
Plan. The options were issued on a pro-rata basis and resulted in no change in fair value. As a result, there was no remaining unvested
stock-based compensation expense under Nexcella.
The
Company recognized stock-based compensation of $ 261,284 related to stock options for the year ended December 31, 2023, which is included
in general and administrative expenses.
F- 22
The
following table summarizes the stock option activity for the year ended December 31, 2024 for Nexcella:
Schedule
of Stock Option Activity
Options
Weighted-
Average Exercise
Price Per Share
Outstanding and exercisable, January 1, 2024
186,528
$ 6.49
Granted
-
$ -
Exercised
-
$ -
Forfeited
( 186,528 )
$ 6.49
Expired
-
$ -
Outstanding and expected to vest, December 31, 2024
-
$ -
Note
8 – Licenses Acquired
Research
and License Agreement with HADASIT and BIRAD
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 $13.0 million 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. The H&B License remains with the Company after the Nexcella Absorption.
On
December 16, 2024, Nexcella entered into the First Amendment to the Research and License Agreement (the “First Amendment”)
with the Licensors. The First Amendment includes terms specific to new licensed products and requires an additional upfront license fee
of $ 1,500,000 , payable no later than April 30, 2025, as well as development milestone payments of up to $ 4.5 million upon the Company’s
achievement of certain milestones.
During
the year ended December 31, 2024 and 2023, the Company recorded research and development expenses of $ 4,639,363 and $ 2,793,712 , respectively,
related to the license agreement and first amendment.
Patent
License Agreement with U.S. Medical Research Foundation
In
August 2024, the Company entered into a Patent License Agreement (“License Agreement”) with a U.S. medical research foundation
pursuant to which the Company was granted certain exclusive and nonexclusive licenses and sublicenses to intellectual and tangible property
for the development and commercialization of cell therapy products (“Licensed Products”). Pursuant to the terms of the License
Agreement, the Company shall pay an up-front payment in three installments of $ 500,000 , with the first installment due concurrent with
the signing of the agreement and the second and third installments due in January and July 2025, respectively. Under the license agreement,
the Company must also pay a mid-single-digit net licensed product sales royalty, and milestone payments corresponding with the initiation
and completion of Phase II studies in the amounts of $ 1.5 million and $ 2 million, respectively, as well as a $ 10 million milestone payment
at the initiation of Phase III studies and a $ 13.5 million dollar milestone payment in the event of first commercial sale of a licensed
product. To date, no amounts have been paid under this license agreement.
F- 23
Note
9 - CIRM Grants
On
July 25, 2024, the Company was awarded an $ 8 million grant from the California Institute for Regenerative Medicine to support the clinical
development of chimeric antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis. The award is
payable to the Company upon achievement of milestones that are primarily based on patient enrollment in the Company’s clinical
trials. Additionally, if CIRM determines, in its sole discretion, that the Company has not complied with the terms and conditions of
the grant, CIRM may suspend or permanently cease disbursements. Funds received under this grant may only be used for allowable project
costs specifically identified with the CIRM-funded project. Such costs can include, but are not limited to, salary for personnel, itemized
supplies, consultants, and itemized clinical study costs. Under the terms of the grant, both CIRM and the Company will co-fund the research
project and the amount of the Company’s co-funding requirement is predetermined as a part of the award. The Company signed the
grant agreement in November 2024 and began receiving funds from the grant in November of 2024. During the year ended December 31, 2024,
the Company received $ 1.9 million in grant reimbursements under the grant agreement. The CIRM grant reimbursements are accrued as an
offset against R&D expenses as reimbursable expenses are incurred.
Note
10 – Leases
In
January 2024, the Company entered into a long-term operating lease agreement for 14,000 square feet of biopharmaceutical manufacturing
space in California under a non-cancelable operating lease that expires in December 2033. Under the terms of the lease, the Company is
required to pay monthly base rents ranging from $ 11,900 to $ 16,218 , and pay its proportionate share of property taxes, insurance and
normal maintenance costs. The lease agreement includes two options to extend the lease for a term of five years each .
The
components of lease cost for operating leases, which are recorded in general and administrative expenses in the year ended December 31,
2024 were as follows:
Schedule
of Lease Cost for Operating Leases
Year Ended
December 31, 2024
Operating lease cost
$ 168,599
Short-term lease cost
56,621
Total lease cost
$ 225,220
The
following table summarizes the lease-related assets and liabilities recorded in the consolidated balance sheets at December 31, 2024:
Schedule
of Lease Related Assets and Liabilities
December 31, 2024
Operating Leases
Operating lease right-of-use assets
$ 989,471
Right of use liability operating lease current portion
$ 65,219
Right of use liability operating lease long term
1,009,551
Total operating lease liabilities
$ 1,074,770
The
Company utilizes the incremental borrowing rate in determining the present value of lease payments unless the implicit rate is readily
determinable. The Company estimated its incremental borrowing rate to be 8 %. The lease has a remaining term of 9.00 years and an implicit
weighted average interest rate of 8 %.
F- 24
The
following table provides the maturities of lease liabilities at December 31, 2024:
Schedule
of Maturity Lease Liability
Operating
Leases
2025
$ 147,798
2026
152,971
2027
158,325
2028
163,866
2029 and thereafter
909,483
Total future undiscounted lease payments
1,532,443
Less: Interest
( 457,673 )
Present value of lease liabilities
$ 1,074,770
Note
11 – Income Taxes
The
Company is subject to taxation in the United States, California and Australia. At December 31, 2024, the Company had federal, state,
and foreign net operating loss (“NOL”) carryforwards of approximately $ 19,850,000 , $ 19,850,000 and $ 4,670,000 , respectively.
The federal loss carryforwards generated after 2017 of approximately $19,800,000 will carryforward indefinitely and can be used to offset
up to 80% of future annual taxable income, while those loss carryforwards generated prior to 2018 begin expiring in 2034, unless previously
utilized. State loss carryforwards also begin expiring in 2034, unless previously utilized, while the Company’s foreign loss carryforward
does not expire . The Company also has federal and California research and development credit carryforwards totaling approximately $ 314,000
and $ 650,000 , respectively, at December 31, 2024. Additionally, the Company has a research orphan tax credit carryover totaling approximately
$ 1,566,000 with a carryover period of 20 years. The Federal credits begin to expire in 2034, unless previously utilized, while the State
credits do not expire. The Company also has foreign withholding tax carryforwards totaling $ 140,000 at December 31, 2024. The foreign
withholding tax carryforward credit begins to expire in 2028, unless previously utilized.
The
Company’s NOL and credit carryforwards to offset future taxable income may be subject to a substantial annual limitation as a result
of ownership changes that could occur in the future pursuant to Internal Revenue Code Sections 382 and 383. These ownership changes may
limit the amount of NOL and credit carryforwards that can be utilized to offset future taxable income and income tax, respectively. In
general, an “ownership change” as defined by the tax code results from a transaction or series of transactions over a three-year
period resulting in an ownership change of more than 50 percent of the outstanding stock of a company by certain stockholders or public
groups.
The
Company’s federal income tax returns from 2019 forward, state income tax returns from 2018 forward, and its Australian tax returns
beginning in 2020 are subject to examination by tax authorities.
A
reconciliation of the provision for income taxes to the amount computed by applying the statutory federal income tax rate to the loss
from operations for the years ended December 31, 2024 and 2023 is as follows:
Schedule
of Provision for Income Taxes
Year Ended
December 31, 2024
Year Ended
December 31, 2023
Expected income tax benefit computed at the statutory rate
$ ( 6,039,482 )
$ ( 4,308,817 )
State income tax benefit, net of federal benefit, net of valuation allowance
-
-
Foreign rate differential
45,967
43,337
Foreign losses not benefited
385,628
404,260
Tax effect of:
Change in valuation allowance
7,746,966
3,849,451
Change in fair value of derivative liability
-
-
Other permanent items and tax credits
( 1,676,951 )
( 298,179 )
Other non-deductible expenses
( 421,091 )
336,363
Provision for income taxes
$ 41,037
$ 26,415
F- 25
Net
deferred tax assets are comprised of the following as of December 31, 2024 and 2023:
Schedule
of Deferred Tax Assets
December 31, 2024
December 31, 2023
Net operating losses
$ 6,708,668
$ 4,081,830
Foreign tax credits
139,978
99,741
Federal & state research credit carryforwards
2,530,635
461,098
Stock-based compensation
775,253
109,859
Amortization of capitalized research and development
5,599,397
2,879,433
Depreciation
10,623
-
Valuation allowance
( 15,764,554 )
( 7,631,961 )
Net deferred tax assets
$ -
$ -
Realization
of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Management assesses the
available positive and negative evidence to estimate if sufficient future taxable income will be generated to use existing deferred tax
assets. Based on the weight of available evidence, including the Company’s history of operating losses, management has determined
that it is more likely than not that the Company’s net deferred tax assets will not be realized. Accordingly, a valuation allowance
has been established by the Company to fully offset these net deferred tax assets.
For
the years ended December 31, 2024 and 2023, domestic and foreign pre-tax losses were as follow:
Schedule
of Pre-tax Loss
December 31, 2024
December 31, 2023
Loss before income taxes - Domestic
$ 20,114,816
$ 13,952,065
Loss before income taxes – Foreign
1,542,510
1,617,042
Loss before income taxes - Consolidated
$ 21,657,326
$ 15,569,107
Note
12 – 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 December 31, 2024 and 2023.
F- 26
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 December 31, 2024, no amounts have been
paid or accrued under the MSA. As of December 31, 2023, the MSA has expired and the Company does not intend to extend the MSA; however,
the royalty obligations survived the termination of the MSA.
Legal
Proceedings
From
time to time, we 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, we do not currently have any pending litigation to which we are a party or to which our property
is subject that we believe 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 our 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, subject to the terms of the agreement which provide that unless the Company and Dr. Rachman have otherwise
agreed in writing, if Dr. Rachman continues to work for the Company after the expiration of the term (which he has), his employment shall
be under the same terms and conditions provided for in the Rachman Employment Agreement, except that his employment will be on an “at
will” basis and the provisions of the agreement allowing for Dr. Rachman to terminate the agreement for “good reason”
and for Dr. Rachman to be paid severance in the event his employment is terminated by the Company without cause or by Dr. Rachman for
good reason will no longer apply, and the Rachman Employment Agreement currently remains in effect pursuant to such terms. 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 November 9, 2022 and May
12, 2023, the Company entered into amendments 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 and $ 446,000 , retroactive as of January 1, 2022 and 2023, respectively and
on November 9, 2023, and (ii) the agreement was amended to entitle 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. On February 6, 2024, the Compensation Committee of the Board of Directors approved an increase in the annual base salary and on
May 9, 2024, the Company entered into an amendment to the Rachman Employment Agreement pursuant to which Dr. Rachman’s annual base
salary was increased to $ 475,000 , effective January 1, 2024. 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 board 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. The full amount of the base salary and any bonus payments are included
in general and administrative expenses.
F- 27
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, which was amended effective June 18, 2021 (as amended, the “Morris
MSA”). The Morris MSA had an initial two-year term, automatically renewable thereafter for successive one year terms unless terminated
by either party, and currently has a term through March 18, 2025. 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 November 9, 2022 and May 12, 2023, the Company
entered into amendments to the Morris MSA dated as of March 24, 2021, pursuant to which (i) Mr. Morris’ annual base salary was
increased to $ 425,000 and $ 446,000 , retroactive as of January 1, 2022 and 2023, respectively, and on November 9, 2023, and (ii) Mr. Morris
is entitled 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. 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 February 6, 2024, the Compensation Committee of the Board of Directors approved an increase in annual base salary,
and on May 9, 2024, the Company entered into an amendment to the Morris MSA pursuant to which Mr. Morris’ annual base salary was
increased to $ 475,000 , effective January 1, 2024. The Morris MSA contains provisions for the protection of the Company’s intellectual
property and confidential information. The full amount of the base salary and any bonus payments are included in general and administrative
expenses.
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 Acting Chief Medical Officer and Head of Clinical Development, is the sole member, regarding Dr. Ross’s
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
13 – Subsequent Events
Common
Stock Issuance – Marketing Services Agreements
Subsequent
to December 31, 2024, the Company issued 34,166 shares of restricted common stock valued at $ 67,500 for investor relations services based
on the average closing price for the prior 10 trading days pursuant to a marketing services agreement entered into on July 25, 2023.
Subsequent
to December 31, 2024, the Company issued 38,840 shares of restricted common stock valued at $ 75,000 for investor relations services based
on the closing price pursuant to the extension of a marketing services agreement entered into on February 29, 2024.
F- 28
ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.