UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2025
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _________to ___________
Commission
File Number: 001-41159
IMMIX
BIOPHARMA, INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware
45-4869378
(State
or other jurisdiction
of
incorporation or organization)
(I.R.S.
Employer
Identification
No.)
11400
West Olympic Blvd. , Suite 200 , Los Angeles , CA
90064
(Address
of principal executive offices)
(Zip
Code)
(310)
651-8041
(Registrant’s
telephone number, including area code)
Not
applicable
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
Common stock, $0.0001
par value
IMMX
The Nasdaq Stock Market
LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company
☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Number
of shares of common stock outstanding as of August 1, 2025 was 28,834,111 .
Page
No.
PART I. FINANCIAL INFORMATION
Item 1.
Financial Statements
5
Condensed Consolidated Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024
5
Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months ended June 30, 2025 and 2024 (Unaudited)
6
Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months ended June 30, 2025 and 2024 (Unaudited)
7
Condensed Consolidated Statements of Cash Flows for the Six Months ended June 30, 2025 and 2024 (Unaudited)
8
Notes to the Condensed Consolidated Financial Statements (Unaudited)
9
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
22
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
31
Item 4.
Controls and Procedures
31
PART II. OTHER INFORMATION
Item 1.
Legal Proceedings
32
Item 1A.
Risk Factors
32
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
33
Item 5.
Other Information
33
Item 6.
Exhibits
34
Signatures
35
2
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This
Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A
of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,”
“should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other
comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections
about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually
achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially
from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements
involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:
●
our projected financial
position and estimated cash burn rate;
●
our estimates regarding
expenses, future revenues and capital requirements;
●
our ability to continue
as a going concern;
●
our need to raise substantial
additional capital to fund our operations, the availability and terms of such funding, and dilution caused thereby;
●
the success, cost and timing
of our clinical trials;
●
our dependence on third
parties in the conduct of our clinical trials;
●
our ability to obtain the
necessary regulatory approvals to market and commercialize our product candidates;
●
the ultimate impact of
a health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole;
●
the potential that results
of pre-clinical and clinical trials indicate our current product candidates or any future product candidates we may seek to develop
are unsafe or ineffective;
●
the results of market research
conducted by us or others;
●
our ability to obtain and
maintain intellectual property protection for our current and future product candidates;
●
our ability to protect
our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our intellectual
property rights;
●
the possibility that a
third party may claim we or our third-party licensors have infringed, misappropriated or otherwise violated their intellectual property
rights and that we may incur substantial costs and be required to devote substantial time defending against claims against us;
3
●
our reliance on third-party
suppliers and manufacturers;
●
the success of competing
therapies and products that are or become available;
●
our ability to expand our
organization to accommodate potential growth and our ability to retain and attract key personnel;
●
our competitive position
and ability to leverage the clinical, regulatory and manufacturing advancements to accelerate our clinical trials and regulatory
approval of product candidates;
●
the potential for us to
incur substantial costs resulting from product liability lawsuits against us and the potential for these product liability lawsuits
to cause us to limit our commercialization of our product candidates;
●
our
ability to quickly leverage our initial product candidates and to progress additional candidates;
●
market acceptance of our
product candidates, the size and growth of the potential markets for our current product candidates and any future product candidates
we may seek to develop, and our ability to serve those markets; and
●
the successful development
of our commercialization capabilities, including sales and marketing capabilities.
All
of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ
materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will
prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties
referred to in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 25, 2025, this Quarterly
Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other documents or filings filed with
or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely affect our business,
prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise
any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances
affecting such forward-looking statements occurring after the date of this Quarterly Report on Form 10-Q, even if such results, changes
or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us
following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements contained in this Quarterly
Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q.
This
Quarterly Report on Form 10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company
surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications,
articles and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained
therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed.
While we believe that such studies and publications are reliable, we have not independently verified market and industry data from third-party
sources, and we have not commissioned any such information.
4
PART
I – FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS.
Immix
Biopharma, Inc.
Condensed
Consolidated Balance Sheets
June 30, 2025
December 31, 2024
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$ 11,637,945
$ 17,681,954
Tax receivable
-
1,974,370
Prepaid expenses and other current assets
687,515
541,510
Total current assets
12,325,460
20,197,834
Other assets
20,418
20,418
Deferred offering cost
110,606
-
Right-of-use asset, net
947,103
989,471
Property and equipment, net
2,231,517
1,740,149
Total assets
$ 15,635,104
$ 22,947,872
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses
$ 9,939,271
$ 8,621,899
Operating lease liability - current
70,467
65,219
Total current liabilities
10,009,738
8,687,118
Operating lease liability – long term
972,335
1,009,551
Total liabilities
10,982,073
9,696,669
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; 28,478,664 shares issued and 28,406,301 shares outstanding at June 30, 2025 and 27,612,383 shares issued and 27,540,020 shares outstanding at December 31, 2024
2,847
2,762
Additional paid-in capital
90,874,877
88,374,131
Accumulated other comprehensive income
65,032
( 1,056 )
Accumulated deficit
( 86,189,762 )
( 75,024,671 )
Treasury stock at cost, 72,363 shares as of June 30, 2025 and December 31, 2024
( 99,963 )
( 99,963 )
Total stockholders’ equity
4,653,031
13,251,203
Total liabilities and stockholders’ equity
$ 15,635,104
$ 22,947,872
See
accompanying notes to the unaudited condensed consolidated financial statements.
5
Immix
Biopharma, Inc.
Condensed
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
2025
2024
2025
2024
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2025
2024
2025
2024
Operating expenses:
General and administrative expenses
$ 2,745,247
$ 2,478,357
$ 5,453,098
$ 4,819,821
Research and development
3,972,458
2,224,139
5,947,532
5,472,808
Total operating expenses
6,717,705
4,702,496
11,400,630
10,292,629
Loss from operations
( 6,717,705 )
( 4,702,496 )
( 11,400,630 )
( 10,292,629 )
Other income (expense):
Interest income
104,056
306,915
254,275
574,823
Total other expense, net
104,056
306,915
254,275
574,823
Loss before provision for income taxes
( 6,613,649 )
( 4,395,581 )
( 11,146,355 )
( 9,717,806 )
Provision for income taxes
8,914
10,269
18,736
19,108
Net loss
( 6,622,563 )
( 4,405,850 )
( 11,165,091 )
( 9,736,914 )
Net loss attributable to non-controlling interests
-
12,914
-
84,987
Net loss attributable to Immix Biopharma, Inc. common stockholders
( 6,622,563 )
( 4,392,936 )
( 11,165,091 )
( 9,651,927 )
Other comprehensive income (loss):
Foreign currency translation
49,569
27,358
66,088
( 17,694 )
Total other comprehensive loss
49,569
27,358
66,088
( 17,694 )
Comprehensive loss
$ ( 6,572,994 )
$ ( 4,365,578 )
$ ( 11,099,003 )
$ ( 9,669,621 )
Loss per common share - basic and diluted
$ ( 0.22 )
$ ( 0.15 )
$ ( 0.37 )
$ ( 0.36 )
Weighted average shares outstanding - basic and diluted
29,983,764
28,785,223
29,844,499
27,068,513
See
accompanying notes to the unaudited condensed consolidated financial statements.
6
Immix
Biopharma, Inc.
Condensed
Consolidated Statements of Stockholders’ Equity
For
the Three and Six Months Ended June 30, 2025 and 2024
(Unaudited)
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, 2024
27,612,383
$ 2,762
$ 88,374,131
$ ( 1,056 )
$ ( 75,024,671 )
( 72,363 )
$ ( 99,963 )
$ -
$ 13,251,203
Shares issued for vested restricted
stock awards
164,315
16
( 16 )
-
-
-
-
-
-
Shares issued for services
148,006
15
266,235
-
-
-
-
-
266,250
Stock-based compensation
-
-
602,109
-
-
-
-
-
602,109
Net loss
-
-
-
-
( 4,542,528 )
-
-
-
( 4,542,528 )
Foreign
currency translation adjustment
-
-
-
16,519
-
-
-
-
16,519
Balance March 31, 2025
27,924,704
$ 2,793
$ 89,242,459
$ 15,463
$ ( 79,567,199 )
( 72,363 )
$ ( 99,963 )
$ -
$ 9,593,553
Shares issued under ATM facility
for cash proceeds, net of offering costs
513,935
51
1,094,348
-
-
-
-
-
1,094,399
Shares issued for exercise of stock options
4,500
-
5,824
-
-
-
-
-
5,824
Shares issued for services
35,525
3
67,497
-
-
-
-
-
67,500
Stock-based compensation
-
-
464,749
-
-
-
-
-
464,749
Net loss
-
-
-
-
( 6,622,563 )
-
-
( 6,622,563 )
Foreign
currency translation adjustment
-
-
-
49,569
-
-
-
-
49,569
Balance June 30, 2025
28,478,664
$ 2,847
$ 90,874,877
$ 65,032
$ ( 86,189,762 )
( 72,363 )
$ ( 99,963 )
$ -
$ 4,653,031
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
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
85,486
9
327,367
-
-
-
-
-
327,376
Stock-based compensation
-
-
615,888
-
-
-
-
-
615,888
Non-controlling interests in
subsidiary
-
-
9,472
-
-
-
-
( 9,472 )
-
Net loss
-
-
-
-
( 5,258,991 )
-
-
( 72,073 )
( 5,331,064 )
Foreign
currency translation adjustment
-
-
-
( 45,052 )
-
-
-
-
( 45,052 )
Balance March 31, 2024
26,468,783
2,648
86,593,132
89,614
$ ( 58,670,286 )
( 72,363 )
( 99,963 )
( 283,282 )
27,631,863
Balance
26,468,783
2,648
86,593,132
89,614
$ ( 58,670,286 )
( 72,363 )
( 99,963 )
( 283,282 )
27,631,863
Shares issued for services
42,901
5
102,495
-
-
-
-
-
102,500
Stock-based compensation
-
-
535,350
-
-
-
-
-
535,350
Non-controlling interests in
subsidiary
-
-
20,200
-
-
-
-
( 20,200 )
-
Buyout of non-controlling interests
in subsidiary
989,876
99
( 316,495 )
-
-
-
-
316,396
-
Net loss
-
-
-
-
( 4,392,936 )
-
-
( 12,914 )
( 4,405,850 )
Foreign
currency translation adjustment
-
-
-
27,358
-
-
-
-
27,358
Balance June 30, 2024
27,501,560
$ 2,752
$ 86,934,682
$ 116,972
$ ( 63,063,222 )
( 72,363 )
$ ( 99,963 )
$ -
$ 23,891,221
Balance
27,501,560
$ 2,752
$ 86,934,682
$ 116,972
$ ( 63,063,222 )
( 72,363 )
$ ( 99,963 )
$ -
$ 23,891,221
See
accompanying notes to the unaudited condensed consolidated financial statements.
7
Immix
Biopharma, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
2025
2024
For the Six Months Ended
June 30,
2025
2024
Operating Activities:
Net loss
$ ( 11,165,091 )
$ ( 9,736,914 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
1,400,608
1,581,114
Depreciation
96,647
6,889
Amortization of right of use asset
42,368
41,256
Changes in operating assets and liabilities:
Tax receivable
2,025,564
( 815,290 )
Prepaid expenses and other current assets
( 145,953 )
( 278,480 )
Other assets
-
( 20,418 )
Accounts payable and accrued expenses
782,904
119,782
Operating lease liability
( 31,968 )
19,244
Net cash used in operating activities
( 6,994,921 )
( 9,082,817 )
Investing Activities:
Purchase of property and equipment
( 195,343 )
( 398,987 )
Net cash used in investing activities
( 195,343 )
( 398,987 )
Financing Activities:
Proceeds from sale of common stock, net of offering costs
1,104,292
15,946,078
Proceeds from exercise of stock options
5,824
2,489
Net cash provided by financing activities
1,110,116
15,948,567
Effect of foreign currency on cash
36,139
( 1,456
Net change in cash and cash equivalents
( 6,044,009 )
6,465,307
Cash and cash equivalents – beginning of period
17,681,954
17,509,791
Cash and cash equivalents – end of period
$ 11,637,945
$ 23,975,098
Supplemental Disclosures of Cash Flow Information:
Income taxes paid
$ 18,736
$ 19,108
Supplemental Disclosures of Noncash Financing Information:
Establishment of right of use asset and liabilities
$ -
$ 1,071,918
Purchase of property and equipment included in accounts payable and accrued expenses
$ 392,672
$ -
Deferred offering costs charged against proceeds from sale of common stock
$ 9,893
$ 87,229
Deferred offering costs accrued
$ 120,499
$ -
Shares issued in subsidiary absorption
$ -
$ 99
Shares issued for vested RSUs
$ 16
$ -
See
accompanying notes to the unaudited condensed consolidated financial statements.
8
Immix
Biopharma, Inc.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited)
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 other serious 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
Basis
of Presentation - The accompanying condensed consolidated financial statements and related notes have been prepared in accordance
with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and in accordance with the rules
and regulations of the United States Securities and Exchange Commission (the “SEC”). The Company’s fiscal year end
is December 31.
The
condensed consolidated financial statements and related disclosures as of June 30, 2025, and for the three and six months ended June
30, 2025 and 2024 are unaudited, pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally
included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations.
In the Company’s opinion, these unaudited condensed consolidated financial statements include all adjustments (consisting only
of normal recurring adjustments) necessary for the fair statement of the results for the interim periods. These unaudited condensed consolidated
financial statements should be read in conjunction with the audited financial statements of the Company for the years ended December
31, 2024 and 2023 which are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2025. The results
of operations for the three and six months ended June 30, 2025, are not necessarily indicative of the results to be expected for the
full year ending December 31, 2025.
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.
9
The
Company has expended and will continue to expend substantial funds to complete the research, development and clinical testing of product
candidates. The Company also will be required to expend additional funds to establish commercial-scale manufacturing arrangements and
to provide for the marketing and distribution of products that receive regulatory approval. The Company may require additional funds
to commercialize its products. The Company is unable to entirely fund these efforts with its current financial resources. If adequate
funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the
scope of or eliminate one or more of its research or development programs which may materially and adversely affect its business, financial
condition and operations.
Use
of Estimates in Financial Statement Presentation - The preparation of these 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 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. The condensed consolidated financial statements do not include any adjustments
to reflect the possible future effects on the recoverability and classification of assets or the amounts of liabilities that may result
from uncertainty related to the Company’s ability to continue as a going concern. The Company had a net loss of $ 6.6 million for
the three months ended June 30, 2025 and an accumulated deficit of $ 86.2 million as of June 30, 2025, as a result of incurring losses
since its inception. Since the initial public offering of its common stock in December
2021, the Company has financed its operations through various equity financing.
10
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 6).
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. During the three months ended
March 31, 2025, the Company received $ 1.7 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. As of June 30 2025, the Company has received $ 3.6 million in grant reimbursements under the grant agreement and $ 4.4
million of remaining awarded funds are expected to be disbursed upon the achievement of milestones.
On
June 3, 2025, the Company entered into an At The Market Offering Agreement (the “June 2025 ATM Agreement”) with Citizens
JMP Securities, LLC (“Citizens”) under which the Company may offer and sell, from time to time at its sole discretion, up
to $ 50
million shares of its common stock (refer to Note 6 – Stockholders’ Equity). During the three and six months ended
June 30, 2025, the Company sold 513,935
shares of common stock pursuant to the June 2025 ATM Agreement
for net proceeds of $ 1,094,399 ,
after offering expenses. As of August 6, 2025, the Company has sold 1,015,347 common shares pursuant to the June 2025 ATM Agreement for net proceeds of $ 2,430,741 ,
after offering expenses.
As of June 30, 2025, the Company had cash and cash equivalents of approximately $ 11.6 million. Management expects the Company to incur losses in the period ending twelve months
from this filing, and believes
that the Company does not have sufficient capital resources to sustain operations through at least the next twelve months from the date
of this filing. The Company plans to seek to address this condition by raising additional capital to finance its operations, although
the availability of, and the Company’s access to such financing is not assured. Accordingly, management believes that there is substantial
doubt regarding the Company’s ability to continue operating as a going concern through at least the next twelve months from the
date of this filing.
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.
11
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 assets 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 June 30, 2025
Level 1
Level 2
Level 3
Assets:
Cash equivalents (money market funds)
$ 5,742,414
$ -
$ -
Cash equivalents (US Treasuries)
3,936,613
$ -
$ -
Cash equivalents
$ 9,679,027
$ -
$ -
As
of June 30, 2025, the Company had no liabilities required to be 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
$ -
$ -
Cash equivalents
$ 15,429,431
$ -
$ -
As
of December 31, 2024, the Company had no liabilities required to be measured at fair value on a recurring basis.
Australian
Tax Incentive – IBAPL is eligible to receive a cash refund from the Australian Taxation Office for eligible research and development
(“R&D”) expenditures under the Australian R&D Tax Incentive Program (the “Australian Tax Incentive”).
The Australian Tax Incentive is recognized as a reduction to R&D expense when there is reasonable assurance that the relevant expenditure
has been incurred, the amount can be reliably measured and that the Australian Tax Incentive will be received. The Company recognized
no reductions to R&D expense for the three months ended June 30, 2025 and $ 231,247 for the three months ended June 30, 2024. The
Company recognized reductions to R&D expense of $ 124 and $ 1,142,787 for the six months ended June 30, 2025 and 2024, respectively.
Deferred
Offering Costs – The Company has capitalized qualified legal, accounting and other direct costs related to its efforts to raise
capital through the sale of its common stock under the June 2025 ATM Agreement. Deferred offering costs will be deferred and amortized
ratably upon sales under the June 2025 ATM Agreement, and upon completion, they will be reclassified to additional paid-in capital as
a reduction of the June 2025 ATM proceeds. If the Company terminates the June 2025 ATM Agreement or there is a significant delay, all
of the deferred offering costs will be immediately written off to operating expenses. As of June 30, 2025, $ 110,606 of deferred offering
costs were capitalized related to the June 2025 ATM Agreement, which are included in deferred offering cost in the accompanying condensed consolidated
balance sheet.
12
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 6). 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 have 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 rates 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 $ ( 5,232 ) and $ 18,705 for the three months ended June
30, 2025 and 2024, respectively, and $ ( 16,884 ) and $ ( 19,477 ) for the six months ended June 30, 2025 and 2024, respectively, and are included
in general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss.
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 three and six months ended June 30, 2025 include 1,913,661 shares
underlying Pre-Funded warrants to purchase common shares (See Note 6). As the shares underlying these Pre-Funded warrants can be issued
for nominal 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. For the three and six months ended June 30, 2025 and 2024, the Company’s potentially dilutive shares,
which were not included in the calculation of net loss per share, included stock options and warrants exercisable for 5,338,488 and 2,908,810
shares of common stock, respectively.
13
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
is 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 June 30, 2025 and December 31, 2024, the Company did not have any finance leases.
Recent
Accounting Pronouncements
In
November 2024, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2024-03 , Disaggregation
of Income Statement Expenses , and in January 2025, the FASB issued ASU 2025-01 , Clarifying the Effective Date (“ASU
2025-01”). The amendments are intended to enhance disclosures regarding an entity’s costs and expenses by requiring additional
disaggregated information disclosures about certain income statement expense line items. The amendments, as clarified by ASU 2025-01,
are effective for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15,
2027. Early adoption is permitted. The Company is currently evaluating the effect of this pronouncement on its disclosures.
Note
3 – Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consist of the following as of June 30, 2025 and December 31, 2024:
Schedule of Prepaid Expenses and Other Current Assets
June 30, 2025
December 31, 2024
Prepaid research and development expenses
$ 437,465
$ 472,508
Prepaid insurance expense
109,746
9,334
Prepaid investor relations expense
2,603
27,397
Other current assets
137,701
32,271
Total prepaid expenses and other current assets
$ 687,515
$ 541,510
Note
4 – Accounts Payable and Accrued Expenses
Accounts
payable and accrued expenses consist of the following as of June 30, 2025 and December 31, 2024:
Schedule of Accounts Payable and Accrued Expenses
June 30, 2025
December 31, 2024
Accounts payable
$ 6,614,389
$ 5,388,494
Accrued research and development expenses
2,423,340
2,423,177
Accrued professional services
146,023
22,500
Accrued compensation and related expenses
702,579
658,161
Other accrued expenses
52,940
129,567
Total accounts payable and accrued expenses
$ 9,939,271
$ 8,621,899
Note
5 – Property and Equipment
Property
and equipment at June 30, 2025 and December 31, 2024 consisted of:
Schedule of Property and Equipment
June 30, 2025
December 31, 2024
Operating equipment
$ 1,177,402
$ 844,740
Office equipment
3,896
3,896
Total property and equipment, gross
1,181,298
848,636
Less: Accumulated depreciation
( 143,901 )
( 47,255 )
Property and equipment
excluding construction in progress
1,037,396
801,381
Construction in progress
1,194,120
938,768
Total property and equipment, net
$ 2,231,517
$ 1,740,149
For
the six months ended June 30, 2025 and 2024, depreciation expense amounted to $ 96,647 and $ 6,889 , 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, construction in progress balances will be classified to their respective property and equipment category.
The
construction in progress of $ 1,194,120 as of June 30, 2025, represents the investment in building a biopharmaceutical processing facility
inside the leased property.
14
Note
6 – 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.
June
2025 ATM Sales Agreement
On
June 3, 2025, the Company entered into the June 2025 ATM Agreement with Citizens under which the Company may offer and sell, from
time to time at its sole discretion, up to $ 50 million
shares of its common stock. Citizens will use commercially reasonable efforts, consistent with its normal trading and sales
practices and applicable state and federal law, rules and regulations and the rules of the Nasdaq Capital Market, to sell the common
stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary
parameters or conditions the Company may impose). The Company will pay Citizens a commission of three percent ( 3 %)
of the gross sales proceeds of any common stock sold through Citizens under the June 2025 ATM Agreement, and has also provided
Citizens with customary indemnification and contribution rights. The Company has reimbursed Citizens for certain specified expenses
in the amount of approximately $ 50,000
in connection with entering into the June 2025 ATM Agreement, and expects to conduct quarterly reimbursements of $ 3,000
throughout the term of the June 2025 ATM Agreement. Initially, the Company is eligible to sell up to $ 13,450,000
worth of shares of its common stock under the June 2025 ATM Agreement subject to the so-called “baby shelf” 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 baby shelf 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 June 2025 ATM Agreement. During the three and six months ended June 30, 2025, the Company sold 513,935 shares
of common stock pursuant to the June 2025 ATM Agreement for net proceeds of $ 1,094,399 ,
after offering expenses. As of August 6, 2025, the Company has sold 1,015,347
common shares pursuant to the June 2025 ATM Agreement for net proceeds of $ 2,430,741 ,
after offering expenses.
Other
Common Stock Issuances
During
the six months ended June 30, 2025, the Company issued 69,691 shares of restricted common stock valued at $ 135,000 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.
During
the six months ended June 30, 2025, 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.
During
the six months ended June 30, 2025, the Company issued 75,000 shares of restricted common stock valued at $ 123,750 for investor relations
services based on the closing price pursuant to the extension of a marketing services agreement entered into on March 16, 2025.
During
the six months ended June 30, 2025, the Company issued 164,315 shares of common stock upon the vesting of restricted stock awards.
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.
15
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 “2nd 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) approve 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 2nd Amended 2021 Plan.
As
of June 30, 2025, there were 2,711,876 shares of the Company’s common stock remaining to be issued under the 2 nd Amended
2021 Plan.
During
the six months ended June 30, 2025, the Compensation Committee of the Board of Directors approved the issuance of options to purchase
198,000 shares of the Company’s common stock 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, an exercise price of $ 2.24 per
share and vest over periods of 12 to 48 equal monthly installments.
During
the six months ended June 30, 2025, the Board of Directors approved the issuance of options to purchase 25,000 shares of the Company’s
common stock to employees of the Company with a term of 10 years and an exercise price of $ 2.20 per share, which options vest in 48 equal
monthly installments.
The
Company recognized stock-based compensation of $ 389,702 and $ 293,802 related to stock options for the three months ended June 30, 2025
and 2024 and $ 824,404 and $ 515,301 related to stock options for the six months ended June 30, 2025 and 2024, respectively, which is included
in general and administrative expenses.
As
of June 30, 2025, the Company had unrecognized stock-based compensation expense of $ 3,476,703 , related to unvested stock options, which
is expected to be recognized over the weighted-average vesting period of 2.78 years.
The
following table reflects the weighted average assumptions used to estimate the fair value of stock options granted during the six months
ended June 30, 2025:
Schedule of Stock Option Valuation Assumption
2025
Volatility
88 - 105 %
Expected life (years)
5.27 - 10.00
Risk-free interest rate
3.98 - 4.58 %
Dividend rate
— %
The
following table summarizes the stock option activity for the six months ended June 30, 2025:
Schedule of Stock Option Activity
Options
Weighted-
Average Exercise
Price Per Share
Outstanding, January 1, 2025
4,065,988
$ 2.02
Granted
903,000
$ 2.24
Exercised
( 4,500 )
$ 1.33
Forfeited
( 19,989 )
$ 2.14
Expired
( 3,511 )
$ 2.14
Outstanding and expected to vest, June 30, 2025
4,940,988
$ 2.06
16
The
following table discloses information regarding outstanding and exercisable options at June 30, 2025:
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
5.70
256,500
$ 0.80
$ 1.01 - 2.00
1,696,562
$ 1.80
6.49
1,325,223
$ 1.80
$ 2.01 - 3.00
2,976,676
$ 2.30
8.86
1,287,654
$ 2.40
$ 3.10 - 6.00
11,250
$ 5.83
6.54
9,610
$ 5.83
4,940,988
$ 2.06
7.88
2,878,987
$ 1.99
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 June 30, 2025, the aggregate intrinsic value for the options
vested and outstanding was $ 699,480 and $ 811,189 , respectively.
The
total intrinsic value of stock options exercised during the six months ended June 30, 2025, was $ 4,532 .
Stock
Warrants
The
following table discloses information regarding outstanding and exercisable, pre-funded and non pre-funded, warrants at June 30, 2025:
Schedule of Stock Outstanding and Exercisable
Outstanding
Exercisable
Exercise
Price
Number
of
Warrant
Shares
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Life (Years)
Number
of
Warrant
Shares
Weighted
Average
Exercise
Price
$
0.0001
1,913,661
$
0.0001
-
1,913,661
$
0.0001
$
0.80
156,000
$
0.80
5.73
156,000
$
0.80
$
6.25
241,500
$
6.25
1.46
241,500
$
6.25
2,311,161
$
0.71
0.54
2,311,161
$
0.71
The
following table summarizes the stock warrant activity for the six months ended June 30, 2025:
Schedule of Stock Warrant Activity
Warrants
Weighted-Average
Exercise Price Per
Share
Outstanding and exercisable (including pre-funded warrants), January 1, 2025
2,311,161
$ 0.71
Granted
-
$ -
Exercised
-
$ -
Forfeited
-
$ -
Expired
-
$ -
Outstanding and exercisable (including pre-funded warrants), June 30, 2025
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 June 30, 2025, the intrinsic value for the
warrants vested and outstanding was $ 4,159,207 .
17
Restricted
Stock Awards
During
the three and six months ended June 30, 2025, the Company recorded stock-based compensation expense of $ 75,046 and $ 167,408 , respectively,
related to the total fair value of the previously issued restricted stock awards, which was included in general and administrative expenses.
As of June 30, 2025, there were no unvested restricted shares.
Note
7 – 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.
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 , $ 250,000 of which was paid during the six months ended June 30, 2025, as well as development milestone payments of up to $ 4.5 million upon the Company’s
achievement of certain milestones.
During
the six months ended June 30, 2025 and 2024, the Company recorded R&D expenses of $ 2,616,569 and $ 1,482,763 , respectively, related
to the license agreement.
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.
18
Note
8 - 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 six months ended June 30, 2025,
the Company received $ 1.7 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. As of June 30 2025, the Company has received $ 3.6 million in grant reimbursements under the grant agreement and $ 4.4
million of remaining awarded funds are expected to be disbursed upon the achievement of milestones.
Note
9 – 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 accompanying condensed
consolidated statement of operations, for the three and six months ended June 30, 2025 and 2024 were as follows:
Schedule of Lease Cost for Operating Leases
Three Months Ended
June 30, 2025
Six Months Ended
June 30, 2025
Operating lease cost
$ 42,150
$ 84,300
Short-term lease cost
14,011
22,411
Total lease cost
$ 56,161
$ 106,711
Three Months Ended
June 30, 2024
Six Months Ended
June 30, 2024
Operating lease cost
$ 42,150
$ 84,300
Short-term lease cost
13,408
31,824
Total lease cost
$ 55,558
$ 116,124
The
following table summarizes the lease-related assets and liabilities recorded in the consolidated balance sheets at June 30, 2025 and
December 31, 2024:
Schedule of Lease Related Assets and Liabilities
June 30, 2025
December 31, 2024
Operating Leases
Operating lease right-of-use assets
$ 947,103
$ 989,471
Right of use liability operating lease current portion
$ 70,467
$ 65,219
Right of use liability operating lease long term
972,335
1,009,551
Total operating lease liabilities
$ 1,042,802
$ 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 8.50 years and an implicit
weighted average interest rate of 8 %.
19
The
following table provides the maturities of lease liabilities at June 30, 2025:
Schedule of Maturity Lease Liability
Operating
Leases
2025 (remaining 6 months)
$ 73,899
2026
152,971
2027
158,325
2028
163,866
2029 and thereafter
909,482
Total future undiscounted lease payments
1,458,543
Less: Interest
( 415,741 )
Present value of lease liabilities
$ 1,042,802
Note
10 – 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 June 30, 2025 and December 31, 2024.
Legal
Proceedings
From
time to time the Company may be involved in claims that arise during the ordinary course of business. Although the results of litigation
and claims cannot be predicted with certainty, the Company does not currently have any pending litigation to which it is a party or to
which its property is subject that it believes to be material. Regardless of the outcome, litigation can be costly and time consuming,
and it can divert management’s attention from important business matters and initiatives, negatively impacting the Company’s
overall operations.
Employment
Agreements
On
June 18, 2021, the Company entered into an Employment Agreement with Ilya Rachman (as amended, the “Rachman Employment Agreement”),
effective for a three-year term, 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.
20
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, 2026. 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 $ 425,00 0 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.
Note
11 – Subsequent Events
Sales under the June 2025 ATM Agreement
Subsequent to June 30, 2025, the Company
has sold 501,412 common shares pursuant to the June 2025 ATM Agreement for net proceeds of $ 1,336,342 , after offering expenses.
21
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
You
should read the following discussion and analysis of our financial condition and results of operations together with our unaudited interim
condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition
to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.
Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include,
but are not limited to, those identified below in “Risk Factors”, and those discussed in the section titled “Risk Factors”
included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as may be amended, supplemented or superseded
from time to time by other reports we file with the SEC. All amounts in this report are in U.S. dollars, unless otherwise noted.
Throughout
this Quarterly Report on Form 10-Q, references to “we,” “our,” “us,” the “Company,” “Immix,”
or “Immix Biopharma” refer to Immix Biopharma, Inc., individually, or as the context requires, collectively with its subsidiaries.
Our
logo and some of our trademarks and tradenames are used in this Report. This Report also includes trademarks, tradenames and service
marks that are the property of others. Solely for convenience, trademarks, tradenames and service marks referred to in this Report may
appear without the ®, ™ and SM symbols. References to our trademarks, tradenames and service marks are not intended to indicate
in any way that we will not assert to the fullest extent under applicable law our rights or the rights of the applicable licensors if
any, nor that respective owners to other intellectual property rights will not assert, to the fullest extent under applicable law, their
rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with,
or endorsement or sponsorship of us by, any other companies.
Certain
capitalized terms used below and otherwise defined below, have the meanings given to such terms in the footnotes to our unaudited consolidated
financial statements included above under “Part I – Financial Information” – “Item 1. Financial Statements”.
Unless
the context otherwise requires and for the purposes of this Report only:
●
“Exchange Act”
refers to the Securities Exchange Act of 1934, as amended;
●
“SEC” or the
“Commission” refers to the United States Securities and Exchange Commission; and
●
“Securities Act”
refers to the Securities Act of 1933, as amended.
Available
Information
We
file annual, quarterly, and current reports, proxy statements and other information with the Securities and Exchange Commission. Our
SEC filings (reports, proxy information statements, and other information) are available to the public over the Internet at the SEC’s
website at www.sec.gov and are available for download, free of charge, soon after such reports are filed with or furnished to the SEC,
on the “Investors,” “SEC Filings” page of our website at www.immixbio.com. Copies of documents filed by us with
the SEC are also available from us without charge, upon oral or written request to our Secretary, who can be contacted at the address
and telephone number set forth on the cover page of this Report. The information contained on the websites referenced in this Report
is not incorporated by reference into this filing. Further, the Company’s references to website URLs are intended to be inactive
textual references only.
22
Overview
Immix
Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on the application of chimeric antigen receptor cell therapy (“CAR-T”)
in light chain (AL) Amyloidosis and other serious diseases. Our lead cell therapy candidate is U.S. Food and Drug Administration (“FDA”)
investigational new drug (“IND”) cleared CAR-T NXC-201 (“NXC-201”), currently being evaluated in our ongoing
United States Phase 1b/2 NEXICART-2 (NCT06097832) clinical trial.
NXC-201
has been awarded Regenerative Medicine Advanced Therapy (“RMAT”) Designation by the FDA, and Orphan Drug Designation (“ODD”)
by both the FDA and European Commission (“EMA”) in AL Amyloidosis.
Our
mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures in
AL Amyloidosis and other serious diseases, as we believe patients are waiting.
Our
strategy is to:
●
Develop our lead candidate
NXC-201 in AL Amyloidosis and other serious diseases; and
●
Pursue development of NXC-201
and additional cell therapy candidates in other applicable indications where CAR-T is not an approved therapy today.
Our
N-GENIUS platform has produced our clinical-stage lead candidate NXC-201, a next-generation CAR-T for AL Amyloidosis and other serious
diseases.
Figure
1: ImmixBio Pipeline
NXC-201
is in clinical trials to treat relapsed/refractory AL Amyloidosis.
AL
amyloidosis is a life-threatening immunological disorder in which an abnormal protein called amyloid builds up in tissues and organs.
This abnormal protein is produced by long-lived plasma cells (“LLPCs”), a type of immune B-cell. The signs and symptoms of
AL amyloidosis vary among patients because build-up may occur in the heart (most frequent cause of mortality), liver, kidneys, intestines,
muscles, joints, nerves, or spleen, according to the National Institutes of Health (“NIH”). Diagnosis is frequently delayed,
due to varied and non-specific symptoms including: fatigue, weight loss, shortness of breath, dizziness, and numbness in hands and feet.
Upon diagnosis, many patients already have late-stage disease, and are not aware of available treatment options and clinical trials.
23
As
of August 2025, there are no FDA approved drugs for relapsed/refractory AL Amyloidosis.
The
U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal
2021, estimated to reach 37,270 patients in 2025. Untreated patients with AL amyloidosis and cardiac involvement have a median survival
of less than 1 year, according to Quock, et al. Journal of Comparative Effective Research, 2023. The current market size for amyloidosis
therapies is estimated at $3.6 billion, expected to reach $6 billion in 2027, according to Grand View Research.
As
of August 2025, we have disclosed treatment of 10 relapsed/refractory AL Amyloidosis patients in the United States in our ongoing Phase
1b/2 multi-site NEXICART-2 (NCT06097832) U.S. clinical trial. Memorial Sloan Kettering Cancer Center is the lead NEXICART-2 clinical
site.
As
of August 2025, we have disclosed treatment of 16 relapsed/refractory AL Amyloidosis patients in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313)
ex-U.S. clinical trial.
In
September 2023, the FDA granted ODD to NXC-201 for the treatment of AL Amyloidosis. If a product that has ODD subsequently receives the
first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusive approval (or exclusivity),
which means that the FDA may not approve any other applications to market the same drug for the same indication for 7 years (except in
limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity).
In
November 2023, the FDA cleared an IND application for NXC-201 to enroll U.S. patients into NXC-201 clinical trials.
In
December 2023, NXC-201 clinical data in relapsed/refractory AL Amyloidosis was presented in an oral presentation at the 65 th
annual American Society of Hematology (“ASH”) meeting, covering 10 relapsed/refractory AL Amyloidosis patients treated with
NXC-201, indicating an overall response rate of 100% (10/10) and a complete response rate of 70% (7/10).
In
February 2024, the European Commission (“EC”) granted orphan drug designation to NXC-201 for the treatment of AL Amyloidosis.
Benefits of European ODD include: 10 years of market exclusivity once authorized in the EU; Access to the EU centralized authorization
procedure; and reduced fees for EU protocol assistance, marketing authorization applications, inspections before authorization, applications
for changes to marketing authorizations made after approval, and reduced annual fees.
In July 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.
In
December 2024, NXC-201 clinical data in relapsed/refractory AL Amyloidosis was presented in an oral presentation at the 66 th
annual ASH meeting, covering 16 relapsed/refractory AL Amyloidosis patients treated with NXC-201, indicating an overall response rate
of 94% (15/16) and a complete response rate of 75% (12/16).
In
February 2025, the FDA granted RMAT designation to NXC-201 for relapsed/refractory AL Amyloidosis. RMAT designation potentially streamlines
the path to FDA approval by allowing frequent interactions with FDA and routes to FDA Accelerated Approval and Priority Review.
In
June 2025, NXC-201 clinical data in relapsed/refractory AL Amyloidosis was presented in an oral presentation at the 2025 American Society
of Clinical Oncology Annual Meeting (ASCO 2025), covering 10 relapsed/refractory AL Amyloidosis patients treated with NXC-201. After
NXC-201 treatment, all patients normalized pathological disease markers. Complete responses (CRs) were observed in 70% (7 out of 10)
of patients treated with NXC-201. The remaining 3 patients are bone marrow minimum residual disease (MRD) negative (10 -6 ),
predicting future CR (Immix believes remaining three MRD negative (10 -6 ) patients could be confirmed as CRs in the coming
weeks and months). Downstream clinical improvement, including cardiac and renal organ responses, were recorded after CRs. There have
been no relapses recorded and no safety signals identified as of the date of this report. Also, as of the date of this report, no neurotoxicity
has been observed and only low-grade cytokine release syndrome has been observed.
In July 2025, the Company expanded the number of clinical trial sites to 18 in its relapsed/refractory AL Amyloidosis
clinical trial NEXICART-2 with a registrational design.
24
Our
Other Programs
Our
other programs include NXC-201 for other serious immune-mediated diseases, a $25 billion combined annual market size according to Grand
View Research and Fortune Business Insights and other preclinical candidates.
Since
inception, we have devoted substantially all of our resources to developing product and technology rights, conducting research and development,
organizing and staffing our Company, business planning and raising capital. We operate as one business segment and have incurred recurring
losses, the majority of which are attributable to research and development activities and negative cash flows from operations. We have
funded our operations primarily through the sale of equity securities and grant proceeds. Currently, our primary use of cash is to fund
operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative
expenditures. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance our product
candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval. In addition, if we obtain
regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing,
marketing, sales and distribution. Furthermore, we incur costs associated with operating as a public company, including significant legal,
accounting, investor relations and other expenses. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year,
depending on the timing of our clinical trials and our expenses on other research and development activities.
Research
and License Agreement with Hadasit and BIRAD
On
December 8, 2022, our subsidiary Nexcella entered into a Research and License Agreement (the “Agreement”) with Hadasit Medical
Research Services & Development, Ltd. and BIRAD – Research and Development Company Ltd. (collectively, the “Licensors”)
pursuant to which the Licensors granted to Nexcella an exclusive, worldwide, royalty-bearing license throughout the world, except Israel,
Cyprus and other countries in the Middle East (the “Territory”), to an invention entitled “Anti-BCMA CAR-T cells to
target plasma cell” to develop, manufacture, have manufactured, use, market, offer for sale, sell, have sold, export and import
the Licensed Product (as defined in the Agreement). Pursuant to the Agreement, Nexcella paid the Licensors an upfront fee of $1,500,000
in December 2022. Additional quarterly payments totaling approximately $13.0 million are due through September 2026 along with an annual
license fee of $50,000. Nexcella has agreed to pay royalties to the Licensors equal to 5% of Net Sales (as defined in the Agreement)
during the Royalty Period. “Royalty Period” means for each Licensed Product, on a country-to-country basis, the period commencing
on December 8, 2022 and ending on the later of (a) the expiration of the last to expire Valid Claim (as defined in the Agreement) under
a Licensed Patent (as defined in the Agreement), if any, in such country, (b) the date of expiration of any other Exclusivity Right (as
defined in the Agreement) or data protection period granted by a regulatory or other governmental authority with respect to a Licensed
Product or (c) 15 years from the date of First Commercial Sale (as defined in the Agreement) of a Licensed Product in such country.
In
addition, Nexcella is required to pay milestone payments of up to $20 million upon the achievement of certain Net Sales milestones as
set forth in the Agreement and Nexcella has committed to funding NXC-201 clinical trials in Israel over 4 years for an estimated total
cost of approximately $13 million, spread on a quarterly basis over that period, which Nexcella believes will generate clinical trial
data owned by Nexcella. The term of the Agreement commenced on December 8, 2022 and, unless earlier terminated pursuant to the terms
thereof, will continue in full force and effect until the later of the expiration of the last Valid Claim under a Licensed Patent or
a Joint Patent (as defined in the Agreement) or Exclusivity Right covering a Licensed Product or the expiration of a continuous period
of 15 years during which there shall not have been a First Commercial Sale of any Licensed Product in any country in the world. Licensors
may terminate the Agreement immediately if Nexcella or its affiliates or sublicensees commences an action in which it challenges the
validity, enforceability or scope of any of the Licensed Patents or Joint Patents. In addition, either party may terminate the Agreement
if the other party materially breaches the Agreement and fails to cure such breach within 30 days. Additionally, Licensors may terminate
the Agreement if Nexcella becomes insolvent or files for bankruptcy.
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, $250,000 of which was paid during the six months ended June 30, 2025, as well as development milestone payments of up to $4.5 million upon the Company’s
achievement of certain milestones. The upfront license fee was paid in full during the six months ended June 30, 2025.
25
CIRM
Grant
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. During the six months ended June 30, 2025,
the Company received $1.7 million in grant reimbursements under the grant agreement. As of August 2025, the Company has received $3.6
million in grant reimbursements under the grant agreement and $4.4 million of remaining awarded funds are expected to be disbursed upon the achievement
of milestones.
June
2025 ATM Sales Agreement
On
June 3, 2025, the Company entered into an At The Market Offering Agreement (the “June 2025 ATM Agreement”) with Citizens
JMP Securities, LLC (“Citizens”) under which the Company may offer and sell, from time to time at its sole discretion,
up to $50 million shares of its common stock. Citizens will use commercially reasonable efforts, consistent with its normal trading
and sales practices and applicable state and federal law, rules and regulations and the rules of the Nasdaq Capital Market, to sell
the common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other
customary parameters or conditions the Company may impose). The Company will pay Citizens a commission of three percent (3%) of the
gross sales proceeds of any common stock sold through Citizens under the June 2025 ATM Agreement, and has also provided Citizens
with customary indemnification and contribution rights. The Company has reimbursed Citizens for certain specified expenses in the
amount of approximately $50,000 in connection with entering into the June 2025 ATM Agreement, and expects to conduct quarterly
reimbursements of $3,000 throughout the term of the June 2025 ATM Agreement. Initially, the Company is eligible to sell up to
$13,450,000 worth of shares of its common stock under the June 2025 ATM Agreement subject to the so-called “baby shelf”
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 baby shelf 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 June 2025 ATM Agreement.. During the three and six months ended June 30, 2025, the Company
sold 513,935 shares of common stock pursuant to the June 2025 ATM Agreement for net proceeds of $1,094,399, after offering expenses.
As of August 6, 2025, the Company has sold 1,015,347 common shares pursuant to the June 2025 ATM Agreement for net proceeds
of $2,430,741, after offering expenses.
26
Results
of Operations
Three
Months Ended June 30, 2025 compared to the Three Months Ended June 30, 2024
General
and Administrative Expense
General
and administrative expenses were $2,745,247 for the three months ended June 30, 2025, compared to $2,478,357 for the three months ended
June 30, 2024.
The
expenses incurred in both periods were related to salaries, patent maintenance costs and general accounting and other general consulting
expenses, which were higher for the three months ended June 30, 2025, due to increases in professional fees of $198,910, compensation
of $148,865, due to hiring of additional employees, and other general expenses of $61,716, slightly offset by decreases of $71,999 in
investor relations expense and stock-based compensation of $70,602.
Research
and Development Expense
Research
and development expense was $3,972,458 for the three months ended June 30, 2025, compared to $2,224,139 for the three months ended June
30, 2024.
The
increase in research and development expenses was primarily driven by an increase in expenses related to our ongoing Phase 1b/2a CAR-T
clinical trial, including, but not limited to, related costs for maintaining and treating patients in the clinical trial, as well as
site onboarding costs and license fees.
Interest
Income
Interest
income was $104,056 for the three months ended June 30, 2025, compared to $306,915 for the three months ended June 30, 2024. Interest
income was related to interest received on investments in money market funds and US Treasuries. The decrease is a result of the Company
maintaining lower balances during the current period.
Provision
for Income Taxes
Provision
for income taxes for the three months ended June 30, 2025 was $8,914 compared to $10,269 for the three months ended June 30, 2024, due
to withholding taxes relating to our Australian subsidiary.
Net
Loss
Net
loss for the three months ended June 30, 2025 was $6,622,563, compared to $4,405,850 for the three months ended June 30, 2024, which
increase was due primarily to the increase in research and development expenses, as discussed above.
Six
Months Ended June 30, 2025 compared to the Six Months Ended June 30, 2024
General
and Administrative Expense
General
and administrative expenses were $5,453,098 for the six months ended June 30, 2025, compared to $4,819,821 for the six months ended June
30, 2024.
The
expenses incurred in both periods were related to salaries, patent maintenance costs and general accounting and other general consulting
expenses, which were higher for the six months ended June 30, 2025, due to increases in compensation of $545,065, due to hiring additional
employees, other general expenses of $102,675, investor relations expenses of $43,961 and professional services of $25,959, slightly
offset by a $84,383 decrease in stock-based compensation.
27
Research
and Development Expense
Research
and development expense was $5,947,532 for the six months ended June 30, 2025, compared to $5,472,808 for the six months ended June 30,
2024.
The
increased research and development expenses during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024,
were related to our ongoing Phase 1b/2a CAR-T clinical trial, including, but not limited to, related costs for maintaining and treating
patients in the clinical trial, as well as site onboarding costs and license fees.
Interest
Income
Interest
income was $254,275 for the six months ended June 30, 2025, compared to $574,823 for the six months ended June 30, 2024. Interest income
in the current period was related to interest received on investments in a money market fund which decreased as a result of the Company
maintaining lower balances in money market funds during the current period.
Provision
for Income Taxes
Provision
for income taxes for the six months ended June 30, 2025 was $18,736 compared to $19,108 for the six months ended June 30, 2024, due to
withholding taxes relating to our Australian subsidiary.
Net
Loss
Net
loss for the six months ended June 30, 2025 was $11,165,091 compared to $9,736,914 for the six months ended June 30, 2024, which increase
was due primarily to the increase in general and administrative expenses and research and development expenses, each as discussed in
greater detail above.
Liquidity
and Capital Resources
Our
primary use of cash and cash equivalents is to fund operating expenses, which consist of clinical research and development expenses,
manufacturing expenses, legal and compliance expenses, compensation and related expenses, and general overhead costs. Cash and cash equivalents
used to fund operating expenses are impacted by the timing of when we pay or prepay these expenses. We expect our expenses to increase
in connection with our ongoing activities, particularly as we expand our clinical programs, continue the research and development of,
and seek marketing approval for our product candidates. In addition, if we obtain marketing approval for any of our product candidates,
we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.
Because
of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are
unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors,
including, but not limited to:
●
the
scope, timing, progress and results of discovery, pre-clinical development, laboratory testing and clinical trials for our product
candidates;
●
the
costs of manufacturing our product candidates for clinical trials and in preparation for regulatory approval and commercialization;
●
the
extent to which we enter into collaborations or other arrangements with additional third parties in order to further develop our
product candidates;
28
●
the
costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending
intellectual property-related claims;
●
the
costs and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies;
●
expenses
needed to attract and retain skilled personnel;
●
the
costs associated with being a public company;
●
the
costs required to scale up our clinical, regulatory and manufacturing capabilities;
●
the
costs of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities,
for any of our product candidates for which we receive regulatory approval; and
●
revenue,
if any, received from commercial sales of our product candidates, should any of our product candidates receive regulatory approval.
In
February and March 2024, we conducted an underwritten public offering of 6,319,025 shares of our common stock, inclusive of the underwriter’s
exercise in full of its over-allotment option, at $2.71 per share, for net proceeds of approximately $15.5 million, after underwriting
discounts and offering expenses.
As
discussed above, on July 25, 2024, the Company was awarded an $8 million grant from CIRM to support the clinical development of chimeric
antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis. As of August 2025, the Company has received
$3.6 million in grant reimbursements under the grant agreement.
In
June 2025, the Company entered into the June 2025 ATM Agreement with Citizens under which the Company may offer and sell, from time to
time at its sole discretion, up to $50 million in shares of its $0.0001 par value common stock, through Citizens as its sales agent.
During the three and six months ended June 30, 2025, the Company sold 513,935 shares of common stock pursuant to the June 2025 ATM Agreement
for net proceeds of $1,094,399, after offering expenses. As of August 6, 2025, the Company has sold 1,015,347 common shares pursuant to the June 2025 ATM Agreement for net proceeds of $2,430,741,
after offering expenses.
As of June 30, 2025, we had total assets of approximately $15.6 million
and working capital of approximately $2.3 million. As of June 30, 2025, our liquidity included approximately $11.6 million of cash and
cash equivalents. We believe that our cash and cash equivalents on hand as of the date of this report, will not be sufficient to fund
our planned operations over the twelve month period following the date of this report. In addition, we believe that we will need additional
capital to continue our planned operations beyond the twelve month period following the filing date of this report. We intend to seek
additional funds through various financing sources, including the sale of our equity and debt securities, government or other third-party
funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements.
In addition, we will consider alternatives to our current business plan that may enable us to achieve revenue producing operations and
meaningful commercial success with a smaller amount of capital. However, there can be no guarantees that such funds will be available
on commercially reasonable terms, if at all. If such financing is not available on satisfactory terms, we may be unable to further pursue
our business plan and we may be unable to continue operations.
To
the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be
diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common
stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting
our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third
parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates,
or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings
or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future
commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market
ourselves.
29
The
continuation of the Company as a going concern is dependent upon its ability to obtain continued financial support from its stockholders,
necessary equity financing to continue operations and the attainment of profitable operations.
In
January 2024, the Company entered into a long-term operating lease agreement for biopharmaceutical manufacturing space in California
under a non-cancelable operating lease that expires in December 2033. Under the terms of the lease we expect to make total lease payments
of $1.5 million through December 2033.
We
enter into contracts in the normal course of business with third-party contract organizations for preclinical and clinical studies, manufacture
and supply of our preclinical and clinical materials and providing other services and products for operating purposes. Contracts for
preclinical and clinical studies and other services generally provide for termination following a certain period after notice, and therefore
we believe that our non-cancelable obligations under these agreements are not material. We do not have any long-term manufacturing and
supply agreements with our third-party contract manufacturers, but we enter into specific contracts on an as needed basis for individual
batch production runs.
Cash
used in operating activities
Net
cash used in operating activities was $6,994,921 for the six months ended June 30, 2025 and $9,082,817 for the six months ended June
30, 2024. Net cash used for the six months ended June 30, 2025 was primarily related to our net loss of $11,165,091, offset by non-cash
items of stock-based compensation expense of $1,400,608, depreciation expense of $96,647 and right of use asset amortization of $42,368.
Operating activities also included an increase in accounts payable and accrued expenses of $782,904, an increase prepaid expenses of
$145,953, and a decrease in the tax receivable of $2,025,564. Net cash used for the six months ended June 30, 2024 was primarily related
to our net loss of $9,736,914, offset by non-cash items of stock-based compensation expense of $1,581,114, depreciation expense of $6,889
and right of use asset amortization of $41,256. Operating activities also included an increase in accounts payable and accrued expenses
of $119,782, an increase in the tax receivable of $815,290, and an increase in prepaid expenses of $278,480.
Cash
used in investing activities
Net
cash used in investing activities was $195,343 for the six months ended June 30, 2025, consisting solely of purchase of property and
equipment, compared to $398,987 for the six months ended June 30, 2024.
Cash
provided by financing activities
Net
cash provided by financing activities was $1,110,116 for the six months ended June 30, 2025 and $15,948,567 for the six months ended
June 30, 2024. Net cash provided by financing activities in 2025 was related to proceeds of $1,104,292 from the sale of common shares
through an at-the-market offering. Net cash provided by financing activities in 2024 was related to proceeds of $425,724 from the sale
of common shares through an at-the-market offering and proceeds of $15,520,354 from the sale of common shares through a public offering
JOBS
Act
On
April 5, 2012, the Jumpstart Our Business Startups Act (the “JOBS Act”) was enacted. Section 107 of the JOBS Act provides
that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of
the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can
delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
We
have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying
with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act.
As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for
complying with new or revised accounting standards.
30
Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,
including, without limitation, (i) providing an auditor’s attestation report on our internal controls over financial reporting
pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended, and (ii) complying with the requirement adopted by the Public
Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on financial statements.
We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total
annual gross revenues of $1.235 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of
the completion of our initial public offering (December 31, 2026); (iii) the date on which we have issued more than $1 billion in nonconvertible
debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the
SEC.
Critical
Accounting Policies and Use of Estimates
Our
financial statements are prepared in accordance with U.S. GAAP. The preparation of these financial statements requires management to
make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. Management regularly evaluates
its estimates and judgments, including those related to revenue recognition, intangible assets, long-lived assets valuation, variable
interest entities, and legal matters. Actual results may differ from these estimates which may be material. “Note 2 – Summary
of Significant Accounting Policies” in Part I, Item 1 of this Quarterly Report on Form 10-Q and in the Notes to Consolidated Financial
Statements in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2024 (the “2024 Form 10-K”),
and “Critical Accounting Policies” in Part II, Item 7 of the 2024 Form 10-K describe the significant accounting policies
and methods used in the preparation of the Company’s financial statements. There have been no material changes to the Company’s
critical accounting policies and estimates since the 2024 Form 10-K.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We
are not required to provide the information required by this Item as we are a “smaller reporting company,” as defined in
Rule 12b-2 of the Exchange Act.
ITEM
4. CONTROLS AND PROCEDURES.
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of
our “disclosure controls and procedures” (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of June 30, 2025,
the end of the period covered by this Quarterly Report on Form 10-Q. The term “disclosure controls and procedures” as defined
in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure
that information required to be disclosed by a company in the reports that it files under the Exchange Act is recorded, processed, summarized
and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it
files under the Exchange Act is accumulated and communicated to a company’s management, including its principal executive officer
and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating
the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated,
cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute
assurance that all control issues and instances of fraud, if any, within a company have been detected. Based on the evaluation of our
disclosure controls and procedures as of June 30, 2025, our management, with the participation of our principal executive officer and
principal financial officer has concluded that, based on such evaluation, as of the end of the period covered by this Quarterly Report
on Form 10-Q, our disclosure controls and procedures were not effective as of June 30, 2025, due to the material weakness in internal
control over financial reporting described below.
31
Material
Weakness in Internal Controls Over Financial Reporting
We
identified a material weakness in our internal control over financial reporting that existed as of December 31, 2024, as discussed in
greater detail in “ Item 9A. Controls and Procedures ” of the 2024 Form 10-K. A material weakness is a deficiency, or
a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material
misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. We determined that we
had a material weakness because, due to our small size, and our limited number of personnel, we did not have in place an effective internal
control environment with formal processes and procedures, including adequate segregation of duties within systems.
Notwithstanding
the material weaknesses in our internal control over financial reporting, we have concluded that the condensed consolidated financial
statements included in this Quarterly Report on Form 10-Q fairly present, in all material respects, our financial position, results of
operations and cash flows for the periods presented in conformity with accounting principles generally accepted in the United States
of America.
Management’s
Plan to Remediate the Material Weakness
With
the oversight of senior management, we continue to work to remediate our material weaknesses, including the establishment of additional
points of segregation of duties across our key processes and the upgrade of our information technology general controls. We will continue
to evaluate and implement procedures that will strengthen our internal controls. We are committed to continuing to improve our internal
control processes and will continue to diligently review our financial reporting controls and procedures.
Inherent
Limitations on Effectiveness of Controls and Procedures
In
designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how
well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. Because of the inherent
limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of
fraud, if any, within the Company have been detected. The design of any system of controls also is based in part upon certain assumptions
about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under
all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance
with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements
due to error or fraud may occur and not be detected.
Changes
in Internal Control
Other
than the remediation actions noted above, there have been no changes in our internal control over financial reporting that occurred during
our last fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
PART
II — OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS.
From
time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation
is subject to inherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm our business.
We are currently not aware of any such legal proceedings or claims that will have, individually or in the aggregate, a material adverse
effect on our business, financial condition or operating results.
ITEM
1A. RISK FACTORS.
Risk factors that affect our business and financial results are discussed
in Part I, Item 1A “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2024 (“Annual Report”)
as filed with the SEC on March 25, 2025, and below. There have been no material changes in our risk factors from those previously disclosed
in our Annual Report, except as set forth below. You should carefully consider the risks described in our Annual Report and below, which
could materially affect our business, financial condition or future results. The risks described in our Annual Report and below, are not
the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may
materially adversely affect our business, financial condition, and/or operating results. If any of the risks actually occur, our business,
financial condition, and/or results of operations could be negatively affected.
Our ability to continue
as a going concern.
Our consolidated financial statements
have been prepared assuming that we will continue to operate as a going concern, which contemplates the realization of assets and the
satisfaction of liabilities in the normal course of business. Based on our current operating plans, we expect our existing cash on hand, CIRM grant funding, and use of our ATM
will fund our planned operating expenses into the third quarter of 2026. Accordingly, based on recurring losses from operations incurred
since inception, the expectation of continued operating losses, and the need to raise additional capital to finance our future operations,
we determined that there is substantial doubt about our ability to continue as a going concern within one year after the date that these
consolidated financial statements are issued. There is no assurance that funding will be available to us, will be obtained on terms favorable
to us or will provide us with sufficient funds to meet our objectives. The reaction of investors to the inclusion of a going concern statement
by our auditors and our potential inability to continue as a going concern may materially adversely affect our share price and our ability
to raise new capital or enter into partnerships. If we become unable to continue as a going concern, we may have to liquidate our assets
and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial
statements.
As of June 30, 2025, the Company had cash and cash equivalents of approximately
$12 million. In addition, the company has $4.4 million remaining to draw on the CIRM grant and $2.4 million was raised via the June 2025
ATM to-date as of Aug 6, 2025.
32
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
Unregistered
Sales of Equity Securities
During
the six months ended June 30, 2025, the Company issued 69,691 shares of restricted common stock valued at $135,000 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.
During
the six months ended June 30, 2025, 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.
During
the six months ended June 30, 2025, the Company issued 75,000 shares of restricted common stock valued at $123,750 for investor relations
services based on the closing price pursuant to the extension of a marketing services agreement entered into on March 16, 2025.
The
issuances described above were exempt from registration pursuant to Section 4(a)(2), and/or Rule 506 of Regulation D of the Securities
Act, since the foregoing issuances did not involve a public offering, the recipient took the securities for investment and not resale,
we took appropriate measures to restrict transfer, and the recipient was (a) an “accredited investor”; and/or (b) had access
to similar documentation and information as would be required in a Registration Statement under the Securities Act. The securities are
subject to transfer restrictions, and the securities contain an appropriate legend stating that such securities have not been registered
under the Securities Act and may not be offered or sold absent registration or pursuant to an exemption therefrom. The securities were
not registered under the Securities Act and such securities may not be offered or sold in the United States absent registration or an
exemption from registration under the Securities Act and any applicable state securities laws.
Purchases
of Equity Securities by the Issuer and Affiliated Purchasers
None.
ITEM
5. OTHER INFORMATION.
Rule
10b5-1 Trading Plans. During the quarter ended June 30, 2025, none of the Company’s directors or officers (as defined in Rule
16a-1(f)) adopted or terminated any contract, instruction or written plan for the purchase or sale of Company securities that was intended
to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement”.
33
ITEM
6. EXHIBITS.
Exhibit No.
Description
10.1
At The Market Offering Agreement dated as of June 3, 2025 between the Company and Citizens JMP Securities, LLC (Filed as Exhibit 1.1 to the Company’s Current Report on Form 8-K which was filed with the Securities and Exchange Commission on June 3, 2025, and incorporated by reference herein).
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1**
Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS*
Inline XBRL Instance Document
101.SCH*
Inline XBRL Taxonomy Extension Schema Document
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104*
Cover Page Interactive Data File - the cover page from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 is formatted in Inline XBRL and included in the Exhibit 101 Inline XBRL Document Set
*
Filed herewith.
**
Furnished herewith.
+
Indicates management contract
or compensatory plan or arrangement.
34
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
IMMIX BIOPHARMA, INC.
Date: August 8, 2025
By:
/s/
Ilya Rachman
Ilya Rachman
Chief Executive Officer
(Principal Executive Officer)
Date: August 8, 2025
By:
/s/ Gabriel
Morris
Gabriel Morris,
Chief Financial Officer
(Principal Financial and Accounting Officer)
35
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.