Immix Biopharma, Inc. 10-K

ITEM 7. 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 plan of operations together with our accompanying consolidated financial statements and the related notes appearing elsewhere in this Annual Report on Form 10-K. 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, and those discussed in the section titled “Risk Factors” included elsewhere in this Annual Report on Form 10-K. All amounts in this report are in U.S. dollars, unless otherwise noted. Overview Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on the application of CAR-T in AL Amyloidosis and other serious diseases. Our lead cell therapy candidate is FDA IND cleared CAR-T NXC-201, currently being evaluated in our ongoing United States Phase 1b/2 NEXICART-2 (NCT06097832) clinical trial and our ex-U.S. phase 1b/2a NEXICART-1 (NCT04720313) clinical trial. 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 convertible debt and equity securities and, to a lesser extent, grant funding. Currently, our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and 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. Public Offering On December 7, 2025, we entered into the 2025 Underwriting Agreement with Morgan Stanley, as representative of the several underwriters named in Schedule 1 thereto, relating to the issuance and sale of 19,117,646 Shares and Pre-Funded Warrants to purchase up to 490,196 shares of common stock. The Shares were sold at a price of $5.10 per share and the Pre-Funded Warrants were sold at a price of $5.09 per Pre-Funded Warrant, which represents the per Share offering price minus the $0.01 per share exercise price for each Pre-Funded Warrant. Private Placement On September 5, 2025 and September 11, 2025, we entered into the September 2025 Securities Purchase Agreements and Registration Rights Agreements with the Purchasers, pursuant to which we sold to the Purchasers in the Private Placement (i) an aggregate of 3,915,604 shares of common stock (ii) Warrants to purchase up to an aggregate of 2,936,709 shares of common stock. The combined purchase price per Share and Warrant was $2.37. The Private Placement closed on September 5, 2025 and September 11, 2025 and aggregate gross proceeds from both closings were approximately $9.3 million, before deducting fees and expenses payable by us. The Warrants are exercisable over a ten-year period at an exercise price of $2.00 per share, subject to proportional adjustments in the event of stock splits or combinations or similar events. The Warrants are not transferable other than to affiliates of the Purchasers, and are exercisable only for cash consideration. Pursuant to the terms of the Registration Rights Agreements, we filed a resale registration statement with the SEC on October 6, 2025 providing for the resale of the shares of common stock and the shares of common stock issuable upon exercise of the Warrants by the Purchasers, which was declared effective by the SEC on December 1, 2025. Pursuant to the terms of the September 2025 Securities Purchase Agreements, effective September 8, 2025, our Board appointed Nancy Chang, Ph.D. as a member of the Board. 68 ATM Agreements June 2025 ATM Sales Agreement On June 3, 2025, we entered into an At The Market Offering Agreement (the “June 2025 ATM Agreement”) with Citizens JMP Securities, LLC (“Citizens”) for offers and sales of up to $50 million shares of common stock through Citizens as sales agent. We paid 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 have also provided Citizens with customary indemnification and contribution rights. Initially, we were eligible to sell up to $13,450,000 of shares of 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 our public float equals or exceeds $75.0 million. Since the aggregate market value of our outstanding shares of common stock held by non-affiliates exceeds $75.0 million, we are no longer subject to the baby shelf limitation on sales set forth in General Instruction I.B.6 of Form S-3. During the three months ended December 31, 2025, we sold 610,123 shares of common stock pursuant to the June 2025 ATM Agreement for net proceeds of $1,836,055, after offering expenses. During the year ended December 31, 2025, we sold 1,697,504 shares of common stock pursuant to the June 2025 ATM Agreement for net proceeds of $4,409,430, after offering expenses. Research and License Agreement with Hadasit and BIRAD On December 8, 2022, Nexcella entered into the Agreement with the Licensors pursuant to which the Licensors granted to Nexcella an exclusive, worldwide, royalty-bearing license in 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 Licensed Product. 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 during the Royalty Period. In addition, Nexcella shall pay sales milestone payments of up to $20 million for Net Sales (as such term is defined in the Agreement) exceeding $700 million 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, shall 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 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 $1.5 million, which has been paid in full as of December 31, 2025, as well as development milestone payments of up to $4.5 million upon the Company’s achievement of certain milestones. Nexcella is a wholly-owned subsidiary of Immix Biopharma, Inc (was merged with and into the Company in May 2024). 69 CIRM Grant On July 25, 2024, we were 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 us upon achievement of milestones that are primarily based on patient enrollment in our clinical trials. Additionally, if CIRM determines, in its sole discretion, that we have 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 we will co-fund the research project and the amount of the Company’s co-funding requirement is predetermined as a part of the award. We signed the grant agreement in November 2024 and begin receiving funds from the grant in November of 2024. As of March 20, 2026, we have received approximately $6.2 million in grant reimbursements under the grant agreement and $1.8 million of remaining awarded funds are expected to be disbursed upon the achievement of milestones. Results of Operations Year Ended December 31, 2025 compared to the Year Ended December 31, 2024 General and Administrative Expenses General and administrative expenses were $13,697,817 for the year ended December 31, 2025 compared to $11,381,978 for the year ended December 31, 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 year ended December 31, 2025, due to increased compensation of $1,213,247 due to the hiring of additional employees, increased investor relations and professional services of $695,152 due to service scope expansion and price increases, and increased other general expenses of $407,440. Research and Development Expenses Research and development expenses were $16,258,598 for the year ended December 31, 2025, compared to $11,292,702 for the year ended December 31, 2024. The increased research and development expenses were related to our ongoing Phase 1b/2a clinical trial and our CAR-T clinical trial, including, but not limited to, CRO and related costs for maintaining and treating patients in the clinical trial, as well as site onboarding costs and license fees. We were able to increase spending on research and development in 2025 as a result of funding from multiple share offerings resulting in net proceeds of $107,349,347, after underwriter discounts and offering expenses. Additionally, the Company received $2,725,000 in CIRM grant reimbursement which is recorded as an offset to research and development expenses. Interest Income Interest income was $555,526 for the year ended December 31, 2025, compared to $1,017,354 of interest income for the year ended December 31, 2024. Interest income in the current year was related to interest received on investments in a money market fund and decreased from the prior year as a result of the Company maintaining lower balances in money market funds during the current year. Provision for Income Taxes Provision for income taxes for the year ended December 31, 2025 was $37,724 compared to $41,037 for the year ended December 31, 2024, due to withholding taxes relating to our Australian subsidiary. 70 Liquidity and Capital Resources Sources of Liquidity We do not have any approved products for commercial sale and have never generated revenue from product sales and have incurred significant net losses since our inception and expect to continue to incur net operating losses for the foreseeable future. We do not expect to receive any revenue from any product candidates that we develop unless and until we obtain regulatory approval and commercialize our product candidates or enter into collaborative arrangements with third parties. We currently have no credit facility or committed sources of capital. Our primary use of cash, cash equivalents, and short-term investments 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, cash equivalents, and short-term investments 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; ● 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, we were 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 March 2026, we have received $6.2 million in grant reimbursements under the grant agreement. 71 In June 2025, we entered into the June 2025 ATM Agreement under which we may offer and sell, from time to time at its sole discretion, up to $50 million in shares of its common stock. During the three months ended December 31, 2025 and the year ended December 31, 2025, we sold 610,123 and 1,697,504 shares, respectively, of common stock pursuant to the June 2025 ATM Agreement for net proceeds of $1,836,055 and $4,409,430, respectively, after offering expenses. In September 2025, we sold to the Purchasers in the Private Placement, pursuant to the September 2025 Securities Purchase Agreements (i) an aggregate of 3,915,604 shares of common stock, and (ii) non-transferable Warrants to purchase up to an aggregate of 2,936,709 shares of common stock for gross proceeds of approximately $9.3 million, before deducting fees and offering expenses payable by us. In December 2025, we conducted an underwritten public offering of 19,117,646 shares of our common stock, at a price of $5.10 per share, and 490,196 Pre-Funded Warrants at a price of $5.09 per Pre-Funded Warrant, for net proceeds of approximately $93.7 million, after underwriting discounts and offering expenses. Material Cash Requirements Our primary use of cash, cash equivalents and short-term investments 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, cash equivalents and short-term investments 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. As of December 31, 2025, we had total assets of approximately $104.8 million and working capital of approximately $91.1 million. As of December 31, 2025, our liquidity included approximately $100.4 million of cash, cash equivalents and short-term investments. We believe that our cash, cash equivalents and short-term investments on hand as of the date of this report coupled with expected disbursements under the CIRM grant, will be sufficient to fund our planned operations over the 12-month period following the date of this report; however, there can be no assurance we will not need additional capital sooner. In addition, we believe that we will need additional capital to continue our planned operations beyond the 12-month period following the 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. 72 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, we 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 $1.4 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 Flows Cash used in operating activities Net cash used in operating activities was $23,930,304 for the year ended December 31, 2025 and $14,595,102 for the year ended December 31, 2024. Net cash used in operating activities for the year ended December 31, 2025 was primarily related to our net loss of $29,438,613, offset by non-cash items of stock-based compensation expense of $2,441,875, depreciation expense of $245,747 and right of use asset amortization of $118,754. Operating activities also included increases in accounts payable and accrued expenses of $1,027,161, and in prepaid expenses of $286,729 partially offset by a decrease in the tax receivable of $2,059,507. Net cash used in operating activities for the year ended December 31, 2024 was primarily related to our net loss of $21,698,363, offset by non-cash items of stock-based compensation expense of $3,020,573, depreciation expense of $32,941 and right of use asset amortization of $82,447. Operating activities also included an increase in accounts payable and accrued expenses of $4,401,623 and an increase in the tax receivable of $971,527, partially offset by a decrease in prepaid expenses of $554,770. Cash used in investing activities Net cash used in investing activities was $7,213,785 for the year ended December 31, 2025, consisting of purchase of property and operating equipment of $732,925 and $6,480,860 for the purchase of short term investments, compared to $1,177,680 for the year ended December 31, 2024. The decrease was related to the completion of the build-out of our manufacturing space in 2025. Cash provided by financing activities Net cash provided by financing activities was $107,386,859 for the year ended December 31, 2025 and $15,948,567 for the year ended December 31, 2024. Net cash provided by financing activities in 2025 was primarily related to proceeds of $107,392,716 from the sale of common stock, which includes $4,409,430 from the sale of common stock through an at-the-market offering. Net cash provided by financing activities in 2024 was related to proceeds of $15,946,078 from the sale of common stock through a public offering. 73 Critical Accounting Estimates This management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to prepaid/accrued research and development expenses, stock-based compensation, value of deferred tax assets and related valuation allowances, and fair value of the embedded derivative financial instrument related to our convertible promissory notes. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in Note 2 to our audited consolidated financial statements included elsewhere in this Annual Report on Form 10-K, we believe the following accounting policies are the most critical to the judgments and estimates used in the preparation of our consolidated financial statements. Stock-Based Compensation We measure all stock-based awards granted based on their estimated fair value on the date of the grant and recognize the corresponding compensation expense for those awarded to employees and directors over the requisite service period, which is generally the vesting period of the respective award, and for those awarded to nonemployees over the period during which services are rendered by nonemployees until completed. We have typically issued stock options with service-based vesting conditions and we record the expense for these awards using the straight-line method. We estimate the fair value of each stock option grant using the Black-Scholes option-pricing model, which uses as inputs the fair value of our common stock and assumptions we make for the volatility of our common stock, the expected term of our stock options, the risk-free interest rate for a period that approximates the expected term of our stock options and our expected dividend yield. The following table reflects the weighted average assumptions used to estimate the fair value of stock options granted during the years ended December 31, 2025 and 2024: 2025 2024 Volatility 88-105 % 98-107 % Expected life (years) 5.27-10.00 5.27-6.02 Risk-free interest rate 3.65-4.58 % 3.56-4.64 % Dividend rate — % — % 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 our therapy candidates, and for license and milestone costs related to in-licensed products and technology. These costs are offset by any reimbursements under grant arrangements. 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 us require substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility and have no alternative future use. 74 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. We monitor the progress of the trials and their related activities and adjust 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. Recent Accounting Pronouncements See Note 2 to our audited consolidated financial statements found elsewhere in this Annual Report on Form 10-K for a description of recent accounting pronouncements applicable to our consolidated financial statements. 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. 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 and (ii) complying with the requirement adopted by the Public Company Accounting Oversight Board (“PCAOB”) 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 (i.e., 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. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK As a smaller reporting company, we are not required to provide the information required by this item. 75