Immix Biopharma, Inc.
For the period ended Mar 31, 2026. Filed May 7, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 7, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-07.
0001493152-25-021325
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001493152-26-021764
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 93 previous paragraphs and 74 current paragraphs.
31 unchanged; 27 reworded; 14 added; 31 removed; 4 previous and 2 current paragraphs rearranged.
Tables are not compared: 4 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (14)
Current report
Overview
Current report
In December 2025, we announced positive interim phase 2 safety and efficacy data from our Phase1/2 NEXICART-2 clinical trial, the first U.S. trial of CAR-T in relapsed/refractory light chain AL, evaluating NXC-201. The results were as of November 13, 2025 and were presented by Heather Landau, MD, of Memorial Sloan Kettering Cancer Center in an oral presentation at the American Society of Hematology’s ASH 2025 Annual Meeting. Prior to NXC-201 treatment, all patients were exposed to an anti-CD38 antibody and a proteasome inhibitor. Median prior lines of therapy were four (range: 1-10). All patients had baseline relapsed/refractory AL Amyloidosis organ involvement.
Current report
In January 2026, the FDA granted Breakthrough Therapy designation to sterically-optimized CAR-T NXC-201 for the treatment of relapsed/refractory AL amyloidosis. Per FDA, Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
Current report
After NXC-201 treatment, complete responses (“CRs”) were observed in 75% (at s/u IFE(-) level) (15 out of 20) patients as determined by an independent review committee. In four out of five pending patients, minimum residual disease (MRD) negativity in bone marrow suggests a future complete response may be expected. Downstream clinical improvement, including organ responses, were observed in 70% of evaluable patients (7/10). No neurotoxicity has been observed. Grade 2 cytokine release syndrome was observed in four patients, Grade 1 cytokine release syndrome was observed in 11 patients, with a median duration of one day.
Current report
Amended June 2025 ATM Agreement
Current report
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”), which was amended on March 25, 2026 (the “June 2025 ATM Amendment No. 1” and, together with the June 2025 ATM Agreement, the “Amended June 2025 ATM Agreement”), pursuant to which we may offer and sell, from time to time, at our option, shares of our common stock, through Citizens, as the sales agent, having an aggregate offering price of up to $100,000,000 in an “at the market offering,” as defined in Rule 415(a)(4) under the Securities Act. During the three months ended March 31, 2026, we sold no shares of common stock pursuant to the June 2025 ATM Agreement and Amended June 2025 ATM Agreement. As of April 30, 2026, we have sold an aggregate of 3,062,504 shares of common stock pursuant to the Amended June 2025 ATM Agreement for net proceeds of $17,101,938, after offering expenses.
Current report
General and administrative expense was $4,823,378 for the three months ended March 31, 2026, compared to $2,707,851 for the three months ended March 31, 2025.
Current report
Research and development expense was $5,980,477 for the three months ended March 31, 2026, compared to $1,975,074 for the three months ended March 31, 2025.
Current report
Sources of Liquidity
Current report
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.
Current report
Material Cash Requirements
Current report
Cash Flows
Current report
Net cash used in investing activities was $4,800,836 for the three months ended March 31, 2026, consisting of $7,768,350 in purchases of short-term investments offset by $3,000,000 in sales of short-term investments. In addition, there was $32,486 in purchases of property and operating equipment. Net cash used in investing activities was $67,713 for the three months ended March 31, 2025, consisting solely of purchase of property and operating equipment.
Current report
Net cash used in financing activities in the three months ended March 31, 2026 of $37,561 was mainly related to $71,093 in payments of deferred offering costs, offset by $33,532 from cash proceeds received from the exercise of common stock options. There were no financing cash flows during the three months ended March 31, 2025.
Removed paragraphs (31)
Previous report
NXC-201 is in clinical trials to treat relapsed/refractory AL Amyloidosis.
Previous report
As of October 2025, there are no FDA approved drugs for relapsed/refractory AL Amyloidosis.
Previous report
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.
Previous report
As of October 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.
Previous report
As of October 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.
Previous report
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).
Previous report
In November 2023, the FDA cleared an IND application for NXC-201 to enroll U.S. patients into NXC-201 clinical trials.
Previous report
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).
Previous report
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.
Previous report
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).
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
June 2025 ATM Sales Agreement
Previous report
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 $3,000 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 months ended September 30, 2025, the Company sold 573,446 shares of common stock pursuant to the June 2025 ATM Agreement for net proceeds of $1,478,976, after offering expenses. During the nine months ended September 30, 2025, the Company sold 1,087,381 shares of common stock pursuant to the June 2025 ATM Agreement for net proceeds of $2,573,375, after offering expenses.
Previous report
September 2025 Securities Purchase Agreements
Previous report
On September 5, 2025, the Company entered into a Securities Purchase Agreement (the “September 2025 Securities Purchase Agreement”) and a Registration Rights Agreement with certain accredited investors (the “Purchasers”), pursuant to which the Company sold to the Purchasers in a private placement transaction (the “Private Placement”) (i) 3,915,604 shares (the “Shares”) of the Company’s common stock, par value $0.0001 (“Common Stock”), and (ii) non-transferable warrants to purchase 2,936,709 shares of Common Stock (the “Warrants”). The purchase price per Share was $2.37. The Private Placement closed on September 5, 2025 and the Company received gross proceeds of approximately $9.3 million, before deducting fees and expenses payable by the Company. The Company intends to use the proceeds from the Private Placement for working capital and general corporate purposes. The non-transferable 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 non-transferable Warrants are not transferable other than to affiliates of the Purchaser, and are exercisable only for cash consideration.
Previous report
General and administrative expenses were $3,078,378 for the three months ended September 30, 2025, compared to $2,949,403 for the three months ended September 30, 2024.
Previous report
Research and development expense was $4,584,131 for the three months ended September 30, 2025, compared to $4,445,528 for the three months ended September 30, 2024.
Previous report
Nine Months Ended September 30, 2025 compared to the Nine Months Ended September 30, 2024
Previous report
General and Administrative Expense
Previous report
General and administrative expenses were $8,531,476 for the nine months ended September 30, 2025, compared to $7,769,224 for the nine months ended September 30, 2024.
Previous report
Research and Development Expense
Previous report
Research and development expense was $10,531,663 for the nine months ended September 30, 2025, compared to $9,918,336 for the nine months ended September 30, 2024.
Previous report
Interest Income
Previous report
Interest income was $338,814 for the nine months ended September 30, 2025, compared to $831,503 for the nine months ended September 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.
Previous report
Provision for Income Taxes
Previous report
Net Loss
Previous report
Net loss for the nine months ended September 30, 2025 was $18,750,783 compared to $16,886,309 for the nine months ended September 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.
Previous report
Net cash used in investing activities was $567,799 for the nine months ended September 30, 2025, compared to $670,529 for the nine months ended September 30, 2024, each consisting solely of purchase of property and equipment.
Previous report
Net cash provided by financing activities was $11,718,263 for the nine months ended September 30, 2025 and $15,948,567 for the nine months ended September 30, 2024. Net cash provided by financing activities in 2025 was primarily related to proceeds of $11,878,678 from the sale of common shares, which includes $2,573,375 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.
Reworded paragraphs (27)
Previous wording
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.
Current wording
Our logo and some of our trademarks and tradenames are used in this Quarterly Report on Form 10-Q. This Quarterly Report on Form 10-Q 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 Quarterly Report on Form 10-Q 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.
Previous wording
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”.
Current wording
Certain capitalized terms used below and otherwise defined below, have the meanings given to such terms in the footnotes to our unaudited condensed consolidated financial statements included above under “Part I – Financial Information” – “Item 1. Financial Statements”.
Previous wording
Unless the context otherwise requires and for the purposes of this Report only:
Current wording
Unless the context otherwise requires and for the purposes of this Quarterly Report on Form 10-Q only:
Previous wording
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.
Current wording
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 “Investor & News,” “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 Quarterly Report on Form 10-Q is not incorporated by reference into this filing. Further, the Company’s references to website URLs are intended to be inactive textual references only.
Previous wording
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.
Current wording
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 CAR-T NXC-201 (“NXC-201”), which is currently being evaluated in our ongoing United States Phase 1b/2 NEXICART-2 (NCT06097832) clinical trial and an ex-U.S. phase 1b/2a NEXICART-1 (NCT04720313) clinical trial. NEXICART-2 is expected to enroll 40 patients, with final readout and Biologics License Application (“BLA”) submission planned thereafter.
Previous wording
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.
Current wording
NXC-201 has been awarded Regenerative Medicine Advanced Therapy (“RMAT”) Designation by the FDA, Orphan Drug Designation (“ODD”) by both the FDA and European Commission (“EC”) in AL Amyloidosis and, most recently, in January 2026, Breakthrough Therapy designation by the FDA for the treatment of relapsed/refractory AL amyloidosis.
Previous wording
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.
Current wording
Our N-GENIUS platform (discussed below) has produced our clinical-stage lead candidate NXC-201, a next-generation CAR-T being designed to treat AL Amyloidosis and other serious diseases.
Previous wording
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.
Current wording
Our other programs include NXC-201 for treatment of select other serious diseases and other preclinical candidates.
Previous wording
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.
Current wording
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 and short-term investment 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.
Previous wording
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.
Current wording
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. Upon the merger of Nexcella with and into Immix, we assumed all of Nexcella’s rights and obligations pursuant to the Agreement.
Previous wording
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.
Current wording
In addition, we are required to pay milestone payments of up to $20.0 million upon the achievement of certain Net Sales milestones as set forth in the Agreement. Pursuant to the Agreement, Nexcella committed to funding NXC-201 clinical trials in Israel for a period of four years for an estimated total cost of approximately $13.0 million, spread on a quarterly basis over that period, the payment of which has been, and will be, paid by us since the merger in May 2024. We expect that the clinical trial data generated by the NXC-201 clinical trials in Israel will be owned by us. 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 we or our affiliates or sublicensees commences an action in which the validity, enforceability or scope of any of the Licensed Patents or Joint Patents is challenged. 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 we become insolvent or file for bankruptcy.
Previous wording
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, which was paid in full during the nine months ended September 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 nine months ended September 30, 2025.
Current wording
On December 16, 2024, our wholly-owned subsidiary, Nexcella, Inc., 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.
Previous wording
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 nine months ended September 30, 2025, the Company received $2.7 million in grant reimbursements under the grant agreement. As of November 2025, the Company has received $4.6 million in grant reimbursements under the grant agreement and $3.4 million of remaining awarded funds are expected to be disbursed upon the achievement of milestones.
Current wording
On July 25, 2024, we were awarded an $8.0 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 our co-funding requirement is predetermined as a part of the award. We signed the grant agreement in November 2024 and began receiving funds from the grant in November of 2024. As of April 30, 2026, we have received $6.7 million in grant reimbursements under the grant agreement.
Previous wording
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 September 30, 2025, due to increases in other general expenses of $369,784, professional fees of $235,251, and compensation of $98,206, due to hiring of additional employees, slightly offset by decreases of $369,784 in investor relations expense driven by less activity, and stock-based compensation of $225,835.
Current wording
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 March 31, 2026, due to increased investor relations and professional fees of $1,174,910 related to the Company’s efforts to raise capital, increased compensation of $607,006 due to hiring of additional employees, and increased other general expenses of $355,724.
Previous wording
The increased research and development expenses during the nine months ended September 30, 2025, as compared to the nine months ended September 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.
Current wording
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 2026 as a result of funding from multiple share offerings during the year ended December 31, 2025. Additionally, the Company received approximately $1.5 million in CIRM grant reimbursement, which is recorded as an offset to research and development expenses.
Previous wording
Interest income was $84,539 for the three months ended September 30, 2025, compared to $256,680 for the three months ended September 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.
Current wording
Interest income was $717,168 for the three months ended March 31, 2026, compared to $150,219 for the three months ended March 31, 2025. Interest income was related to interest received on investments in money market funds and US Treasuries. The increase is a result of the Company maintaining higher balances during the current period.
Previous wording
Provision for income taxes for the three months ended September 30, 2025 was $7,722 compared to $11,144 for the three months ended September 30, 2024, due to withholding taxes relating to our Australian subsidiary.
Current wording
Provision for income taxes for the three months ended March 31, 2026 was $0 compared to $9,822 for the three months ended March 31, 2025, due to withholding taxes relating to our Australian subsidiary.
Previous wording
Net loss for the three months ended September 30, 2025 was $7,585,692, compared to $7,149,395 for the three months ended September 30, 2024, which increase was due primarily to the increase in research and development expenses, as discussed above.
Current wording
Net loss for the three months ended March 31, 2026 was $10,086,687 compared to $4,542,528 for the three months ended March 31, 2025, which increase was due primarily to the increase in research and development expenses, as discussed above.
Previous wording
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.
Current wording
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.
Previous wording
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 November 2025, the Company has received $4.6 million in grant reimbursements under the grant agreement.
Current wording
As discussed above, on July 25, 2024, the Company was awarded an $8.0 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 April 30, 2026, we have received $6.7 million in grant reimbursements under the grant agreement.
Previous wording
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 nine months ended September 30, 2025, the Company sold 573,446 and 1,087,381 shares, respectively, of common stock pursuant to the June 2025 ATM Agreement for net proceeds of $1,478,976 and $2,573,375, respectively, after offering expenses.
Current wording
On March 25, 2026, the Company and Citizens entered into the June 2025 ATM Agreement Amendment No. 1, pursuant to which, effective March 25, 2026, the Company may offer and sell, from time to time, at its option, shares of its common stock, through Citizens, as the sales agent, having an aggregate offering price of up to $100,000,000 in an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. During the three months ended March 31, 2026, we sold no shares of common stock pursuant to the June 2025 ATM Agreement and Amended June 2025 ATM Agreement. As of April 30, 2026, we have sold an aggregate of 3,062,504 shares of common stock pursuant to the Amended June 2025 ATM Agreement for net proceeds of $17,101,938, after offering expenses.
Previous wording
In September 2025, the Company entered into the September 2025 Securities Purchase Agreements with the Purchasers, pursuant to which the Company sold to the Purchasers in a private placement transaction (i) 3,915,604 shares of the Company’s common stock, and (ii) non-transferable warrants to purchase 2,936,709 shares of common stock for net proceeds of approximately $9.3 million, after underwriting discounts and offering expenses.
Current wording
In September 2025, we sold to certain accredited investors, in private placement transaction, pursuant to 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.
Previous wording
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.
Current wording
In December 2025, we conducted an underwritten public offering of 19,117,646 shares of our common stock, at a public offering price of $5.10 per share, and pre-funded warrants to purchase 490,196 shares of common stock, at a public offering price of $5.09 per pre-funded warrant, for net proceeds of approximately $93.7 million, after underwriting discounts and offering expenses.
Previous wording
As of September 30, 2025, we had total assets of approximately $20.1 million and working capital of approximately $5.7 million. As of September 30, 2025, our liquidity included approximately $15.9 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.
Current wording
As of March 31, 2026, we had total assets of approximately $95.8 million and working capital of approximately $81.7 million. As of March 31, 2026, our liquidity included approximately $90.6 million of cash and 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, 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 filing date of this Quarterly Report on Form 10-Q. 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.
Previous wording
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.
Current wording
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 approximately $1.3 million through December 2033.
Previous wording
Net cash used in operating activities was $12,900,697 for the nine months ended September 30, 2025 and $13,118,904 for the nine months ended September 30, 2024. Net cash used for the nine months ended September 30, 2025 was primarily related to our net loss of $18,750,783, offset by non-cash items of stock-based compensation expense of $1,871,079, depreciation expense of $193,633 and right of use asset amortization of $80,237. Operating activities also included an increase in accounts payable and accrued expenses of $1,818,025, an increase in prepaid expenses of $95,381, and a decrease in the tax receivable of $2,047,128. Net cash used in operating activities for the nine months ended September 30, 2024 was primarily related to our net loss of $16,886,309, offset by non-cash items of stock-based compensation expense of $2,314,920, depreciation expense of $12,338 and right of use asset amortization of $61,713. Operating activities also included an increase in accounts payable and accrued expenses of $2,120,531, an increase in the tax receivable of $746,748, and an increase in prepaid expenses of $7,932.
Current wording
Net cash used in operating activities was $9,817,073 for the three months ended March 31, 2026 and $1,685,140 for the three months ended March 31, 2025. Net cash used for the three months ended March 31, 2026 was primarily related to our net loss of $10,086,687, offset by non-cash items of stock-based compensation expense of $575,565, depreciation expense of $91,577, right of use asset amortization of $39,189, loss on disposal of fixed assets of $34,153, slightly offset by realized gain on available-for-sale securities of $10,648. Operating activities also included an increase in accounts payable and accrued expenses of $443,059 and an increase in prepaid expenses of $867,320. Net cash used for the three months ended March 31, 2025 was primarily related to our net loss of $4,542,528, offset by non-cash items of stock-based compensation expense of $868,359, depreciation expense of $38,153 and right of use asset amortization of $21,027. Operating activities also included a decrease in the tax receivable of $2,003,580, an increase in accounts payable and accrued expenses of $258,718, and an increase in prepaid expenses of $316,622.
Previous wording
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.
Current wording
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 Condensed Consolidated Financial Statements in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Form 10-K”), as filed with the SEC on March 25, 2026, and “Critical Accounting Policies” in Part II, Item 7 of the 2025 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 2025 Form 10-K.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
We are required 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.
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
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 nine months ended September 30, 2025, due to increases in compensation of $643,271, due to hiring additional employees, other general expenses of $493,812, and professional services of $261,210, offset by decreases in investor relations expenses of $325,823, driven by less activity, and stock-based compensation of $310,218.
Previous report — wording carried elsewhere
Provision for income taxes for the nine months ended September 30, 2025 was $26,458 compared to $30,252 for the nine months ended September 30, 2024, due to withholding taxes relating to our Australian subsidiary.