AIM ImmunoTech Inc.
For the period ended Sep 30, 2026. Filed Nov 12, 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.
Sep 30, 2026 · Filed Nov 12, 2026
AIM$0.15+0.1%Stored close · as of Nov 12, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-07.
0001493152-26-036609
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-12.
0001493152-26-051439
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 179 previous paragraphs and 165 current paragraphs.
113 unchanged; 38 reworded; 14 added; 12 removed; 16 previous and 0 current paragraphs rearranged.
Tables are not compared: 14 previous and 22 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
On July 31, 2026, the Company entered into a proposal with Sterling Pharma Solutions (“Sterling”) that is related to the Master Service Agreement and a Quality Agreement entered into between the Company and Sterling in 2022. Pursuant to the Sterling Proposal Agreement, Sterling agreed to manufacture further batches of the polynucleotide drug substances PolyI and Poly C12U and transfer of associated test methods at Sterling’s Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen. The estimated cost to the Company under the Sterling Proposal Agreement is approximately $1.5 million to be paid over a period of 12 months, as set forth in more detail in the Sterling Proposal Agreement. The Company anticipates using the manufactured product for ongoing and future clinical trials, including potentially a Phase 3 clinical trial for metastatic pancreatic cancer.
Current report
The Company’s net loss for the quarter ended September 30, 2026 was $3.1 million compared with a net loss of $3.3 million for the quarter ended September 30, 2025, a decrease of approximately $141 thousand. The decrease in net loss was primarily attributable to the absence in the 2026 period of the $4.0 million loss on issuance of warrants recognized in the third quarter of 2025 (partially offset in that period by a $670 thousand gain on the change in fair value of warrants) and a $322 thousand decrease in interest expense and other finance costs, substantially offset by a $3.0 million decrease in interest and other income, reflecting the nonrecurring gain recognized in the third quarter of 2025 upon the settlement of previously billed legal fees, and a $510 thousand increase in operating loss.
Current report
Interest expense was $259 thousand and $581 thousand for the three months ended September 30, 2026 and 2025, respectively. The decrease in interest expense resulted from reduced debt pursuant to principal reductions in 2026.
Current report
During the three months ended September 30, 2026, holders of the Company’s Series G Preferred Stock converted an aggregate of 8 shares of preferred stock into 8,000 shares of the Company’s common stock in accordance with the original conversion terms. As a result of the conversion, the carrying value of the converted preferred stock was reclassified to common stock and additional paid-in capital. No fractional shares were issued, and no cash was paid upon conversion. No Class G Warrants were exercised.
Current report
During the nine months ended September 30, 2026, holders of the Company’s Series G Preferred Stock converted an aggregate of 1,321 shares of preferred stock into 1,321,000 shares of the Company’s common stock in accordance with the original conversion terms. As a result of the conversion, the carrying value of the converted preferred stock was reclassified to common stock and additional paid-in capital. No fractional shares were issued, and no cash was paid upon conversion. There were also 310,000 Class G Warrants exercised.
Current report
At September 30, 2026 and December 31, 2025, the Company had 521 and 0 shares of Series G Convertible Preferred Stock and 3,374,000 and 0 Class G Warrants outstanding, respectively. Subsequent to September 30, 2026, holders of the Company’s Series G Preferred Stock converted an aggregate of 25 shares of preferred stock into 25,000 shares of the Company’s common stock in accordance with the original conversion terms.
Current report
May 2026 Class H Inducement Transaction
Current report
May 2026 Class I Offering
Current report
At September 30, 2026 there were 451,161 Placement Agent Warrants and 15,038,702 Class I Warrants outstanding.
Current report
June 2026 Class J Offering
Current report
The combined offering price was approximately $0.52 per share and accompanying warrant. Gross proceeds to the Company totaled approximately $2.6 million.
Current report
On May 18, 2026, the Company and the Lender entered into Amendment #2, which amended the Note and further extended the maturity date of the Note until June 30, 2027. Pursuant to the Amendment, the Company agreed to pay the Lender an extension fee in the amount of $10 thousand. The Extension Fee was added to the outstanding balance of the Note. The Amendment also contains customary representations and warranties of the Company, as well as a representation and warranty of the Company that, as of the date of the Amendment, the outstanding balance of the Note, following the application of the Extension Fee, was approximately $1.7 million.
Current report
During the nine months ended September 30, 2026, the Company entered into a total of ten exchange agreements and, for each, a corresponding partitioned promissory note with Streeterville Capital, LLC related to that certain Promissory Note dated February 16, 2024. Pursuant to the Exchange Agreements and Partitioned Promissory Notes, the Company and the Lender converted approximately $1.9 million of the Promissory Note into 6,392,202 shares of the Company’s common stock, at an average conversion price of approximately $0.49 per share. Consequently, as of September 3, 2026, the Promissory Note was satisfied in full and there are no longer any amounts owing under the Promissory Note
Current report
On July 15, 2026, our stockholders approved a series of alternate amendments to our Certificate of Incorporation to effect, at the discretion of our Board of Directors, a reverse stock split of our outstanding common stock at a ratio of up to 1-for-25. As of the date of this Report, our Board of Directors has not effected a reverse stock split.
Removed paragraphs (12)
Previous report
Interferons are a group of proteins produced and secreted by cells to combat diseases. Researchers have identified four major classes of human interferon: alpha, beta, gamma and omega. Alferon N Injection contains a multi-species form of alpha interferon. The worldwide market for injectable alpha interferon-based products has experienced rapid growth and various alpha interferon injectable products are approved for many major medical uses worldwide. Alpha interferons are manufactured commercially in three ways: by genetic engineering, by cell culture, and from human white blood cells. All three of these types of alpha interferon are or were approved for commercial sale in the United States. Our natural alpha interferon is produced from human white blood cells. The potential advantages of natural alpha interferon over recombinant (i.e., synthetic) interferon produced and marketed by other pharmaceutical firms may be based upon their respective molecular compositions. Natural alpha interferon is composed of a family of proteins containing many molecular species of interferon. In contrast, commercial recombinant alpha interferon products each contain only a single species. Researchers have reported that the various species of interferons may have differing antiviral activity depending upon the type of virus. Natural alpha interferon presents a broad complement of species, which we believe may account for its higher activity in laboratory studies. Natural alpha interferon is also glycosylated (i.e., partially covered with sugar molecules). We believe that the absence of glycosylation may be in part responsible for the production of interferon-neutralizing antibodies seen in patients treated with recombinant alpha interferon. Although cell culture-derived interferon is also composed of multiple glycosylated alpha interferon species, the types and relative quantity of these species are different from our natural alpha interferon.
Previous report
Subsequently, on August 4, 2026, a holder exercised pre-funded warrants to purchase 481,788 shares of common stock upon exercise of the pre-funded warrants and received nominal cash proceeds from the exercise.
Previous report
Total costs and expenses decreased to $5.8 million for the six months ended June 30, 2026, compared with $6.3 million for the six months ended June 30, 2025, representing a decrease of approximately 8.2%.
Previous report
Equity transactions
Previous report
For the three months ended June 30, 2026, 149 shares of the Series G Preferred had been converted for 149,000 shares of common stock and no Class G Warrants were exercised. For the six months ended June 30, 2026, 1,313 shares of the Series G Preferred had been converted for 1,313,000 shares of common stock, and 310,000 Class G Warrants had been exercised. Subsequent to June 30, 2026, 8 shares of the G Preferred had been converted to 8,000 shares of common stock. At June 30, 2026 3,374,000 Class G Warrants and 529 Series G Preferred were outstanding.
Previous report
Subsequently, on August 4, 2026, a holder exercised pre-funded warrants to purchase 481,788 shares of common stock upon exercise of the pre-funded warrants and received nominal cash proceeds from the exercise.
Previous report
On September 6, 2024, an amendment to an agreement dated April 7, 2022, was executed by us and Amarex clarifying and changing the nature of the remaining execution fee of $725 thousand. The amendment allowed that the remainder would not be exclusive to the agreement dated on April 7, 2022, that the nature of the payment changed from an execution fee to a fully refundable deposit, and that it could be applied to any invoice upon mutual agreement of the parties, removed the threshold contingencies, and if such invoices were not sufficient to exhaust the balance, that the refund would be refunded in cash. Due to the changes brought about by the amendment, the nature of the payment changed to deposit status. At June 30, 2026, we had a remaining deposit of $128 thousand which may be used to offset future clinical research expenditures. This deposit is listed as a non-current asset on the balance sheet but could provide working capital if the timing of expenditures are realized within the next 12 months.
Previous report
On May 7, 2026, the Company entered into a warrant exercise inducement offer letter agreement with certain holders of existing warrants, pursuant to which the holders agreed to exercise their warrants in cash at a reduced exercise price for aggregate gross proceeds of approximately $3.6 million in consideration of the Company’s agreement to issue new warrants upon such exercise.
Previous report
We are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed to commercialize the many potential therapeutic aspects of our experimental drugs and our FDA approved drug Alferon N Injection.
Previous report
Possible Sources of Funding
Previous report
Equity Distribution Agreement
Previous report
The Company plans to enter into a new Equity Distribution Agreement in August 2026.
Reworded paragraphs (38)
Previous wording
Oncology is one of the areas of biotech known for multibillion-dollar mergers and acquisitions deals – large-market Phase 3 oncology clinical trials with positive data are a desirable focus for acquisition. AIM strongly believes that such a Phase 3 study will be possible following the ongoing Phase 2 clinical study evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the “DURIPANC” study). The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The primary objective of the study is the clinical benefit rate of the combination therapy. The secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life. According to the Erasmus MC Cancer Institute, the promising progression-free survival and overall survival seen in Phase 1 of the study – which we believe supported advancement to the ongoing Phase 2 portion of the study – continue to be seen. As of June 30, 2026, all subjects have been enrolled in the study and have received the first dose of study medication. Erasmus MC expects that detailed data will be published later this year. According to Erasmus MC, there has also been no significant toxicity – an encouraging safety profile for a post-chemo setting – and Ampligen subjects are consistently reporting “high” quality of life during treatment.
Current wording
Oncology is one of the areas of biotech known for multibillion-dollar mergers and acquisitions deals – large-market Phase 3 oncology clinical trials with positive data are a desirable focus for acquisition. AIM strongly believes that such a Phase 3 study will be possible following the ongoing Phase 2 clinical study evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the “DURIPANC” study). DURIPANC is a Phase 1 / 2 investigator-initiated, exploratory, open-label, single-center study. The primary objective of the study is the clinical benefit rate of the combination therapy. The secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life. According to the Erasmus MC Cancer Institute, the promising progression-free survival and overall survival seen in Phase 1 of the study – which we believe supported advancement to the ongoing Phase 2 portion of the study – continue to be seen. As of September 30, 2026, all subjects were enrolled in the study and completed Ampligen treatment, while durvalumab treatment continues. AIM anticipates topline results in the first quarter of 2027, followed by the analysis of overall survival in the third quarter of 2027. According to Erasmus MC, there has been no significant toxicity – an encouraging safety profile for a post-chemo setting – and Ampligen subjects are consistently reporting “high” quality of life during treatment.
Previous wording
In July 2023, we enrolled and dosed the first patient in our Phase 2 study evaluating Ampligen® as a potential therapeutic for people with post-COVID conditions (“AMP-518”). We announced in August 2023 that the study had met the planned enrollment of 80 subjects ages 18 to 60 years who have been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. In January 2025, we announced that the final Clinical Study results from AMP-518 had been posted to ClinicalTrials.gov. The results support our belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue, and that this would be the likely subject population for any follow-up clinical trial.
Current wording
In July 2023, we enrolled and dosed the first patient in our Phase 2 study evaluating Ampligen® as a potential therapeutic for people with post-COVID conditions (“AMP-518”). We announced in August 2023 that the study had met the planned enrollment of 80 subjects ages 18 to 60 years who have been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. In January 2025, we announced that the final Clinical Study results from AMP-518 had been posted to ClinicalTrials.gov. The results support our belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue, which would be the likely subject population for any follow-up clinical trial.
Previous wording
Our primary pharmaceutical product platform consists of Ampligen (rintatolimod), a first-in-class drug of large macromolecular double-stranded (ds) RNA (ribonucleic acid) molecules. Ampligen is the only known TLR3 agonist to avoid helicase activation of NF-κB. Natural dsRNAs and poly IC which activate NF-κB in the tumor microenvironment (TME) and have the potential to enhance cancer cell proliferation. Alferon Injection is an FDA-approved natural alpha-interferon product.
Current wording
Our primary pharmaceutical product platform consists of Ampligen (rintatolimod), a first-in-class drug of large macromolecular double-stranded (ds) RNA (ribonucleic acid) molecules. Ampligen is the only known TLR3 agonist to avoid helicase activation of NF-κB. Natural dsRNAs and poly IC activate NF-κB in the tumor microenvironment (TME) and have the potential to enhance cancer cell proliferation. Alferon Injection is an FDA-approved natural alpha-interferon product.
Previous wording
We have received approval of our NDA from ANMAT for the commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS. The product would be marketed by GP Pharm – now Filaxis – our commercial partner in Latin America. Shipment of the drug product to Argentina was initiated in 2018 to complete the release testing by ANMAT needed for commercial distribution. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. In June 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. Collaboration with Filaxis continues for commercial launch of Ampligen in Argentina and they are currently in the process of renewing the existing license. To successfully bring this to market, several key steps are necessary, including building disease awareness, providing medical education, securing appropriate reimbursement, developing effective market strategies, and finalizing manufacturing preparations for launch.
Current wording
We have received approval of our NDA from ANMAT for the commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS. The product would be marketed by Filaxis (formerly GP Pharm), our commercial partner in Latin America. Shipment of the drug product to Argentina was initiated in 2018 to complete the release testing by ANMAT needed for commercial distribution. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. In June 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. Collaboration with Filaxis continues for commercial launch of Ampligen in Argentina and they are currently in the process of renewing the existing license. To successfully bring this to market, several key steps are necessary, including building disease awareness, providing medical education, securing appropriate reimbursement, developing effective market strategies, and finalizing manufacturing preparations for launch.
Previous wording
The economic landscape in Argentina has changed dramatically since then with the country experiencing significant hyper-inflation. As contracts in Argentina are U.S. dollar contracts, the parties must evaluate the impact of the devaluation on the relationship and the ability to go forward on a U.S.-dollar basis. The combination of the cost and frequency of treatments has rendered CFS treatments in Argentina cost prohibitive, at least for the time being. We will therefore focus our efforts with Filaxis on an approval in Argentina for pancreatic cancer.
Current wording
The economic landscape in Argentina has changed dramatically since 2020, with the country experiencing significant hyper-inflation. As contracts in Argentina are U.S. dollar contracts, the parties must evaluate the impact of the devaluation on the relationship and the ability to go forward on a U.S.-dollar basis. The combination of the cost and frequency of treatments has rendered CFS treatments in Argentina cost prohibitive, at least for the time being. We have shifted our focus and efforts with Filaxis toward approval in Argentina for pancreatic cancer.
Previous wording
We consider patent exclusivity as a crucial component of our business. As of June 30, 2026, we had 31 patents worldwide with 21 additional pending patent applications comprising our intellectual property.
Current wording
We consider patent exclusivity as a crucial component of our business. As of September 30, 2026, we had 33 patents worldwide with 19 additional pending patent applications comprising our intellectual property.
Previous wording
The AMP-511 Expanded Access Program (“AMP-511”) is an open-label treatment protocol allowing Ampligen access to severely debilitated CFS patients. The AMP-511 protocol started in the 1990s and is ongoing. The data collected from the AMP-511 protocol through clinical sites provide safety information regarding the use of Ampligen in patients with CFS. We are establishing an enlarged database of clinical safety information which we believe will provide further documentation regarding the absence of autoimmune disease associated with Ampligen treatment. We believe that continued efforts to understand existing data, and to advance the development of new data and information, will ultimately support our future filings for Ampligen and/or the design of future clinical studies that the FDA requested in a CRL. The FDA approved an increased reimbursement level from $200 to $345 per 200 mg vial of Ampligen, due to increased production costs; which was re-authorized in 2021, 2022, 2023, 2024, 2025 and 2026. At this time, we do not plan on passing this adjustment along to the patients in this program.
Current wording
The AMP-511 Expanded Access Program (“AMP-511”) is an open-label treatment protocol allowing Ampligen access to severely debilitated CFS patients. The AMP-511 protocol started in the 1990s and is ongoing. The data collected from the AMP-511 protocol through clinical sites provide safety information regarding the use of Ampligen in patients with CFS. We are establishing an enlarged database of clinical safety information which we believe will provide further documentation regarding the absence of autoimmune disease associated with Ampligen treatment. We believe that continued efforts to understand existing data, and to advance the development of new data and information, will ultimately support our future filings for Ampligen and/or the design of future clinical studies that the FDA requested in a CRL. The FDA approved an increased reimbursement level from $200 to $345 per 200 mg vial of Ampligen, due to increased production costs; which was re-authorized in 2021, 2022, 2023, 2024, 2025 and 2026.
Previous wording
In July 2023, we enrolled and dosed the first patient in our Phase 2 study evaluating Ampligen as a potential therapeutic for people with post-COVID conditions (“AMP-518”). We announced in August 2023 that the study had met the planned enrollment of 80 subjects ages 18 to 60 years who had been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. All patients completed the study, and topline data was reported in February 2024.
Current wording
In July 2023, we enrolled and dosed the first patient in our Phase 2 study evaluating Ampligen as a potential therapeutic for people with post-COVID conditions (“AMP-518”). The study enrolled 80 subjects ages 18 to 60 years who had been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. All patients completed the study, and topline data was reported in February 2024.
Previous wording
Jubilant HollisterStier (“Jubilant”) has been our authorized CMO for Ampligen since 2017. Multiple lots of Ampligen were produced from 2018 to 2023. AIM currently has adequate stock of Ampligen for ongoing clinical purposes. In addition, we have supplied GP Pharm, now Filaxis, with the Ampligen required for testing and ANMAT release under the agreement that GP Pharm, now Filaxis, would be the eventual distributor in Argentina.
Current wording
Jubilant HollisterStier (“Jubilant”) has been our authorized CMO for Ampligen since 2017. Multiple lots of Ampligen were produced from 2018 to 2023. AIM currently has adequate stock of Ampligen for ongoing clinical purposes. In addition, we have supplied Filaxis (formerly GP Pharm), with the Ampligen required for testing and ANMAT release under the agreement that Filaxis, would be the eventual distributor in Argentina.
Previous wording
Our business plan calls for the potential utilization of one or more CMOs. While we believe we have sufficient Ampligen API to meet our current needs, we are also continually exploring new efficiencies so as to maximize our ability to fulfill future obligations. In December 2022, we entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”) for the manufacture of our Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’s Dudley, UK, location to produce the polymer precursors to manufacture the drug Ampligen. We are utilizing Sterling’s expertise to refine our approach to polymer production; the validation of the polymer production process with Sterling is ongoing.
Current wording
Our business plan calls for the potential utilization of one or more CMOs. While we believe we have sufficient Ampligen API to meet our current needs, we are also continually exploring new efficiencies to maximize our ability to fulfill future obligations. In December 2022, we entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”) for the manufacture of our Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’s Dudley, UK, location to produce the polymer precursors to manufacture the drug Ampligen. We are utilizing Sterling’s expertise to refine our approach to polymer production; the validation of the polymer production process with Sterling is ongoing.
Previous wording
Beginning in May 2016, we have had an exclusive Renewed Sales, Marketing, Distribution and Supply Agreement (the “Agreement”) with GP Pharm, now Filaxis. Under this Agreement, GP Pharm is responsible for gaining regulatory approval in Argentina for Ampligen to treat severe CFS in Argentina and for commercializing Ampligen for this indication in Argentina. We granted GP Pharm the right to expand rights to sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance milestones. The contract ended date May 24, 2024. While we are in discussions with Filaxis to extend the agreement, we are also open to the possibility of looking for a new partner. In August 2021, ANMAT granted a five-year extension to a previous approval to sell and distribute Ampligen to treat severe CFS in Argentina. This extends the approval until 2026.
Current wording
Beginning in May 2016, we have had an exclusive Renewed Sales, Marketing, Distribution and Supply Agreement (the “Agreement”) with Filaxis (formerly GP Pharm). Under this Agreement, Filaxis is responsible for gaining regulatory approval in Argentina for Ampligen to treat severe CFS in Argentina and for commercializing Ampligen for this indication in Argentina. We granted Filaxis the right to expand rights to sell this experimental therapeutic into other Latin America countries based upon the achievement of certain performance milestones. The Agreement expired on May 24, 2024. While we are in discussions with Filaxis to extend the agreement, we are also open to the possibility of looking for a new partner. In August 2021, ANMAT granted a five-year extension to a previous approval to sell and distribute Ampligen to treat severe CFS in Argentina. This extends the approval until 2026 and they are currently in the process of renewing the existing license.
Previous wording
In February 2013, we received approval from Argentina’s ANMAT for Alferon N Injection (under the brand name “Naturaferon”) for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon. In JANMAT granted a five-year extension in 2017; a request to extend the approval beyond 2022 has been filed and is still under review. GP Pharm, now renamed Filaxis, has decided not to move forward with this project and has sent us a notice of termination for this project. However, as there are numerous companies in Argentina now providing patients treatment with recombinant interferon, we believe these companies and their patients would benefit greatly from having the opportunity to treat those refractory patients with Naturaferon. We are continuing to seek out potential partners.
Current wording
In February 2013, we received approval from Argentina’s ANMAT for Alferon N Injection (under the brand name “Naturaferon”) for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon. ANMAT granted a five-year extension in 2017; a request to extend the approval beyond 2022 has been filed and is still under review. Filaxis, has decided not to move forward with this project and has sent us a notice of termination for this project. However, as there are numerous companies in Argentina now providing patients treatment with recombinant interferon, we believe these companies and their patients would benefit greatly from having the opportunity to treat those refractory patients with Naturaferon. We are continuing to seek out potential partners.
Previous wording
The Company’s operating results may fluctuate significantly depending on the pace of patient enrollment in our clinical trials, particularly the ongoing DURIPANC study for pancreatic cancer. Patient enrollment has varied, which directly impacts the timing and amount of clinical trial expenditures. Additionally, our ability to maintain compliance with NYSE American listing requirements and the trading status of our common stock may affect our ability to raise capital and, consequently, our ability to fund ongoing operations and clinical development activities. We cannot predict with certainty the timing of regulatory decisions or clinical trial outcomes, which represent material uncertainties that could significantly impact our future results of operations.
Current wording
The Company’s operating results may fluctuate significantly depending on the timing and pace of our clinical development activities, including the completion of the ongoing DURIPANC study for pancreatic cancer, the manufacture of polymer under the Sterling Proposal Agreement and the planned initiation of a Phase 3 clinical trial, which directly impacts the timing and amount of research and development expenditures. Additionally, our ability to maintain compliance with NYSE American listing requirements and the trading status of our common stock may affect our ability to raise capital and, consequently, our ability to fund ongoing operations and clinical development activities. We cannot predict with certainty the timing of regulatory decisions or clinical trial outcomes, which represent material uncertainties that could significantly impact our future results of operations.
Previous wording
The following table sets forth, for the periods indicated, certain items in our Condensed Consolidated Statements of Income ($ in thousands):
Current wording
The following table sets forth, for the periods indicated, certain items in our Condensed Consolidated Statements of Operations ($ in thousands):
Previous wording
Total costs and expenses increased to $3.5 million for the quarter ended June 30, 2026, compared with $2.7 million for the quarter ended June 30, 2025, an increase of approximately 32.5%.
Current wording
Total costs and expenses increased to $3.0 million for the quarter ended September 30, 2026, compared with $2.5 million for the quarter ended September 30, 2025, an increase of approximately 20.5%.
Previous wording
Research and development costs declined to $589 thousand during the quarter ended June 30, 2026 compared with $1.2 million during the quarter ended June 30, 2025. Research costs declined as the Company completed a Phase II study in 2026 and shifted its focus toward a European Pancreatic Cancer study which is funded by a grant and in collaboration with a major pharmaceutical interest. The Company expects to begin new studies shortly and the timing and amount of clinical expenditures is dependent on recruiting patients and therefore can be difficult to project and lead to significant expense variations between periods.
Current wording
Research and development costs increased to $846 thousand during the quarter ended September 30, 2026 compared with $607 thousand during the quarter ended September 30, 2025. The Company expects to begin new studies shortly and the timing and amount of clinical expenditures is dependent on recruiting patients and therefore can be difficult to project and lead to significant expense variations between periods. The increase was primarily due to costs incurred under an agreement for the production of Poly I and Poly C12U polynucleotides which began during the third quarter of 2026.
Previous wording
General and administrative costs for the quarter ended June 30, 2026 were $1.5 million above those during the three months ended June 30, 2025 due to increases in issuance costs together with legal and accounting fees associated with the equity transactions
Current wording
General and administrative costs for the quarter ended September 30, 2026 were $328 thousand above those during the three months ended September 30, 2025 due to increases in salaries and director fees that were waived a year ago.
Previous wording
The Company’s net loss for the six months ended June 30, 2026 was $6.8 million compared with a net loss of $6.5 million for the six months ended June 30, 2025, an increase of $300 thousand. The increase in net loss was primarily attributed to offering related costs incurred in connection with multiple equity transactions completed during the period, including placement agent fees, legal fees, accounting fees, and other direct costs, as discussed below. These increased costs were partially offset by lower research and development expenses.
Current wording
The Company’s net loss for the nine months ended September 30, 2026 was $10.0 million compared with a net loss of $9.8 million for the nine months ended September 30, 2025, an increase of approximately $171 thousand. The increase in net loss was primarily attributed to offering related costs incurred in connection with multiple equity transactions completed during the period, including placement agent fees, legal fees, accounting fees, and other direct costs, as discussed below. These increased costs were partially offset by lower research and development expenses. Additionally, during the quarter ended September 30, 2025, the Company reached an agreement with a vendor to waive legal fees which resulted in a large nonrecurring gain recorded as other income.
Previous wording
On May 7-8, 2026, the Company entered into inducement letter agreements with eight existing warrant holders pursuant to which such holders agreed to immediately exercise an aggregate of 7,451,920 previously outstanding Class A through Class F Warrants at an exercise price of $0.48 per share, generating gross proceeds to the Company of approximately $3.6 million. In connection with the inducement, the Company reduced the exercise price of the outstanding Class A through Class F Warrants to $0.48 per share. In consideration for the immediate exercises, the Company issued to such holders an aggregate of 14,903,840 new Class H Common Stock Purchase Warrants with an exercise price of $0.60 per share and a five-year term commencing on the Stockholder Approval Date. In connection with the inducement transaction, the Company also issued 447,116 Placement Agent Warrants to Ladenburg Thalmann & Co., Inc. with an exercise price of $0.60 per share and a five-year term commencing on the issue date, issued pursuant to the Investment Banking Agreement dated April 9, 2026. The Class H Warrants and Class H Placement Agent Warrants are equity-classified. The Class H Warrants are not exercisable until the Company obtains stockholder approval (See Note 17: Subsequent Events) and include a beneficial ownership limitation of 4.99%, or 9.99% upon election, customary anti-dilution adjustments, cashless exercise rights if there is no effective registration statement or available prospectus for resale of the underlying shares, and fundamental transaction provisions.
Current wording
On May 7-8, 2026, the Company entered into inducement letter agreements with eight existing warrant holders pursuant to which such holders agreed to immediately exercise an aggregate of 7,451,920 previously outstanding Class A through Class F Warrants at an exercise price of $0.48 per share, generating gross proceeds to the Company of approximately $3.6 million. In connection with the inducement, the Company reduced the exercise price of the outstanding Class A through Class F Warrants to $0.48 per share. In consideration for the immediate exercises, the Company issued to such holders an aggregate of 14,903,840 new Class H Common Stock Purchase Warrants with an exercise price of $0.60 per share and a five-year term commencing on the Stockholder Approval Date. In connection with the inducement transaction, the Company also issued 447,116 Placement Agent Warrants to Ladenburg Thalmann & Co., Inc. with an exercise price of $0.60 per share and a five-year term commencing on the issue date, issued pursuant to the Investment Banking Agreement dated April 9, 2026. The Class H Warrants and Class H Placement Agent Warrants are equity-classified. The Class H became exercisable upon receipt of stockholder approval at the special meeting of stockholders held on July 15, 2026, and include a beneficial ownership limitation of 4.99%, or 9.99% upon election, customary anti-dilution adjustments, cashless exercise rights if there is no effective registration statement or available prospectus for resale of the underlying shares, and fundamental transaction provisions.
Previous wording
The transaction generated gross exercise proceeds of approximately $3.6 million. The Company recognized equity issuance costs equal to the gross proceeds of the transaction, consisting of approximately $561 thouand of placement-agent costs and approximately $3.0 million of holder-side inducement consideration. The remaining approximately $3.6 million of value transferred to the exercising warrant holders exceeded the proceeds available to absorb the transaction costs and was recognized as a deemed dividend. Because the Company had an accumulated deficit, the deemed dividend was recorded as a reduction of additional paid-in capital.
Current wording
The transaction generated gross exercise proceeds of approximately $3.6 million. The Company recognized equity issuance costs equal to the gross proceeds of the transaction, consisting of approximately $561 thousand of placement-agent costs and approximately $3.0 million of holder-side inducement consideration. The remaining approximately $3.6 million of value transferred to the exercising warrant holders exceeded the proceeds available to absorb the transaction costs and was recognized as a deemed dividend. Because the Company had an accumulated deficit, the deemed dividend was recorded as a reduction of additional paid-in capital.
Previous wording
On May 21, 2026, the Company closed a registered direct offering (the ‘May 2026 Class I Offering’) of 7,519,351 registered shares of common stock and Class I Common Stock Purchase Warrants to purchase up to 15,038,702 shares of common stock at an exercise price of $0.325 per share, exercisable for a five-year period commencing on the Stockholder Approval Date.
Current wording
On May 21, 2026, the Company closed a registered direct offering (the ‘May 2026 Class I Offering’) of 7,519,351 registered shares of common stock and, in a concurrent private placement, Class I Common Stock Purchase Warrants to purchase up to 15,038,702 shares of common stock at an exercise price of $0.325 per share, exercisable for a five-year period commencing on the Stockholder Approval Date.
Previous wording
Ladenburg Thalmann & Co., Inc. acted as the placement agent for the May 2026 Class I Offering and received an 8.0% cash commission of approximately $196 thousand, a 0.75% management fee of approximately $18 thousand, reimbursement of expenses of $100 thousand, and 451,161 Placement Agent Warrants exercisable at approximately $0.41 per share (125% of the offering price) for a five-year period from the effective date of the Registration Statement. The Class I Warrants and Class I Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds between the common stock and the Class I Warrants, resulting in allocations of approximately $939 thousand to common stock and $1.5 million to Class I Warrants. The Class I Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder meeting to be held no later than July 21, 2026. (See Note 17: Subsequent Events)
Current wording
Ladenburg Thalmann & Co., Inc. acted as the placement agent for the May 2026 Class I Offering and received an 8.0% cash commission of approximately $196 thousand, a 0.75% management fee of approximately $18 thousand, reimbursement of expenses of $100 thousand, and 451,161 Placement Agent Warrants exercisable at approximately $0.41 per share (125% of the offering price) for a five-year period from the effective date of the Registration Statement. The Class I Warrants and Class I Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds between the common stock and the Class I Warrants, resulting in allocations of approximately $939 thousand to common stock and $1.5 million to Class I Warrants. The Class I Warrants became exercisable upon receipt of stockholder approval at the special meeting of stockholders held July 15, 2026.
Previous wording
Ladenburg Thalmann & Co., Inc. acted as the placement agent for the June 2026 Class J Offering and received an 8.0% cash commission of approximately $212 thousand, a 0.75% management fee of approximately $20 thousand, reimbursement of expenses of $100 thousand, and 306,494 Placement Agent Warrants exercisable at approximately $0.65 per share with a five-year term. The Class J Warrants, June 2026 Pre-Funded Warrants, and Class J Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds among the common stock, Pre-Funded Warrants, and Class J Warrants. The Class J Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder meeting to be held no later than July 21, 2026 (concurrent with the Class I and Class H Warrants). (See Note 17: Subsequent Events)
Current wording
Ladenburg Thalmann & Co., Inc. acted as the placement agent for the June 2026 Class J Offering and received an 8.0% cash commission of approximately $212 thousand, a 0.75% management fee of approximately $20 thousand, reimbursement of expenses of $100 thousand, and 306,494 Placement Agent Warrants exercisable at approximately $0.65 per share with a five-year term. The Class J Warrants, June 2026 Pre-Funded Warrants, and Class J Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds among the common stock, Pre-Funded Warrants, and Class J Warrants. The Class J Warrants, together with the Class H and Class I Warrants, became exercisable upon receipt of stockholder approval at the special meeting of stockholders held on July 15, 2026.
Previous wording
For the three months ended June 30, 2026, prefunded warrants were exercised for 1,300,828 shares of common stock. At June 30, 2026 481,788 Pre-Funded Warrants, 306,494 Placement Agent Warrants and 10,216,476 Class J Warrants were outstanding.
Current wording
For the three months ended September 30, 2026, prefunded warrants were exercised for 481,788 shares of common stock. For the nine months ended September 30, 2026, prefunded warrants were exercised for 1,782,616 shares of common stock. At September 30, 2026 there were 306,494 Placement Agent Warrants and 10,216,476 Class J Warrants were outstanding and there were no Pre-Funded Warrants outstanding.
Previous wording
Research and development costs declined to $1.1 million during the six months ended June 30, 2026 compared with $2.3 million during the six months ended June 30, 2025. During the first quarter of 2025, the Company decided to direct its focus and efforts on the development of Ampligen for the treatment of late-stage pancreatic cancer, with the belief that this path will potentially lead to the most lucrative outcome. As a result, the Company evaluated its patent portfolio and made a decision to reduce its annual maintenance fees and development of patents not meeting its current core objective. As a result, $335 thousand was charged to clinical expenses during the first quarter of 2025 related to prior costs of developing and maintaining patents not specific to the primary focus and was a significant factor in the variance between the quarters.
Current wording
Research and development costs declined to $1.9 million during the nine months ended September 30, 2026 compared with $2.9 million during the nine months ended September 30, 2025. During the first quarter of 2025, the Company decided to direct its focus and efforts on the development of Ampligen for the treatment of late-stage pancreatic cancer, with the belief that this path will potentially lead to the most lucrative outcome. As a result, the Company evaluated its patent portfolio and made a decision to reduce its annual maintenance fees and development of patents not meeting its current core objective. As a result, $335 thousand was charged to clinical expenses during the first quarter of 2025 related to prior costs of developing and maintaining patents not specific to the primary focus and was a significant factor in the variance.
Previous wording
Additionally, the Company’s Phase 2 study for pancreatic cancer was put on hold in 2025, which resulted in reduced clinical costs during the first six months of 2026 than during the same time period in 2025. The Company has shifted its focus toward a European Pancreatic Cancer study which is funded by a grant and in collaboration with a major pharmaceutical interest. The Company expects to begin a pivotal phase 3 clinical trial after the final DURIPANC study results become available and a study protocol has been finalized and the timing and amount of clinical expenditures is dependent on recruiting patients and therefore can be difficult to project and lead to significant expense variations between periods.
Current wording
Additionally, the Company’s Phase 2 AMP-270 study for pancreatic cancer was put on hold in 2025, which resulted in reduced clinical costs during the first nine months of 2026 than during the same time period in 2025. The Company expects to begin a pivotal Phase 3 clinical trial following the completion of the ongoing DURIPANC study and finalization of a new Phase 3 study protocol. The timing and amount of clinical expenditures is dependent on recruiting patients and therefore can be difficult to project and lead to significant expense variations between periods.
Previous wording
General and administrative costs for the six months ended June 30, 2026 were $675 thousand above the six months ended June 30, 2025 as a result of increases in issuance costs together with legal and accounting fees associated with the equity transactions. During the six months ended June 30, 2025, the Company was receiving final billings related to a shareholder dispute which was settled during the fourth quarter of 2024 which reduced the impact of the additional fees incurred during the current year.
Current wording
General and administrative costs for the nine months ended September 30, 2026 were $1 million above the nine months ended September 30, 2025 as a result of increases in issuance costs together with legal and accounting fees associated with the equity transactions. During the nine months ended September 30, 2025, the Company was receiving final billings related to a shareholder dispute which was settled during the fourth quarter of 2024 which reduced the impact of the additional fees incurred during the current year.
Previous wording
Interest expense was $295 thousand and $149 thousand for the three months ended June 30, 2026 and 2025, respectively. The increase in interest expense is due to additional debt. On November 18, 2025, the Company (“Borrower”) entered into a Note Purchase Agreement with Streeterville Capital LLC (“Streeterville” or the “Lender”). Under the terms of the agreement, Streeterville paid the Company $2.5 million in exchange for an unsecured promissory Note with an Original Issue Discount of $781 thousand. The Company will pay $3.3 million consisting of the principal amount of the Note, together with the original issue discount and $20 thousand of lender transaction fees, no later than November 18, 2027. The stated interest rate of the note is 10%.
Current wording
Interest expense was $858 thousand and $854 thousand for the nine months ended September 30, 2026 and 2025, respectively. The increase in interest expense is due to additional debt. On November 18, 2025, the Company (“Borrower”) entered into a Note Purchase Agreement with Streeterville Capital LLC (“Streeterville” or the “Lender”). Under the terms of the agreement, Streeterville paid the Company $2.5 million in exchange for an unsecured promissory Note with an Original Issue Discount of $781 thousand. The Company agreed to pay $3.3 million consisting of the principal amount of the Note, together with the original issue discount and $20 thousand of lender transaction fees, no later than November 18, 2027. The stated interest rate of the note is 10%.. As of September 30, 2026, approximately $1.7 million of principal remained outstanding under this note, following the exchange of approximately $1.0 million of the note for shares of common stock during September 2026.
Previous wording
Cash balances increased by $6.9 million or 231.7% during the six months ended June 30, 2026, primarily the result of ongoing financing initiatives. The Company raised $1.8 million from a grant of rights offering, $2.5 million from its ATM offering, and $5.7 million from warrant exercises, $1.6 million from the rights offering and $5.3 million from registered directs net of issuance costs during the quarter ended June 30, 2026.
Current wording
Cash balances increased by $3.9 million or 130.7% during the nine months ended September 30, 2026, primarily the result of ongoing financing initiatives. The Company raised $1.8 million from a grant of rights offering, $2.5 million from its ATM offering, and $5.7 million from warrant exercises, and $5.3 million from registered directs net of issuance costs during the nine months ended September 30, 2026.
Previous wording
Cash used by operating activities increased during the six months ended June 30, 2026 when compared to the six months ended June 30, 2025 primarily due to the utilization of cash for accounts payable and accrued expenses as well as administrative costs associated with equity transactions.
Current wording
Cash used by operating activities increased during the nine months ended September 30, 2026 when compared to the nine months ended September 30, 2025 primarily due to the utilization of cash for prepaid expenses and increased operating losses.
Previous wording
During the six months ended June 30, 2025, the Company utilized a portion of its investments to provide cash for operations. During the six months ended June 30, 2026, the Company utilized financing activities to provide the necessary operating funds which caused a $1.8 million difference in cash from investing activities when comparing the periods.
Current wording
During the nine months ended September 30, 2025, the Company utilized a portion of its investments to provide cash for operations. During the nine months ended September 30, 2026, the Company utilized financing activities to provide the necessary operating funds which caused a $2.2 million difference in cash from investing activities when comparing the periods.
Previous wording
Our principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide the necessary funding to meet our obligations as they become due. As of June 30, 2026, we had $10.0 million in cash, cash equivalents and marketable investments, inclusive of $64 thousand in marketable securities, compared with $3.0 million as of December 31, 2025.
Current wording
Our principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide the necessary funding to meet our obligations as they become due. As of September 30, 2026, we had $6.9 million in cash, cash equivalents and marketable securities, inclusive of $61 thousand in marketable securities, compared with $3.0 million as of December 31, 2025.
Previous wording
On December 11, 2024, we received an official notice of noncompliance with the NYSE American’s continued listing requirements specifically relating to a required stockholders’ equity of $6 million or more. The NYSE American’s review showed that we were not in compliance with that requirement. We submitted a plan (the “Plan”) to the NYSE American detailing actions we would take to regain compliance by June 11, 2026. The NYSE American accepted our Plan on February 26, 2025. If we had been unable to regain compliance by June 11, 2026, our common stock was subject to delisting from the NYSE American. As of June 30, 2026, our stockholders’ equity was $7.7 million.
Current wording
On December 11, 2024, we received an official notice of noncompliance with the NYSE American’s continued listing requirements specifically relating to a required stockholders’ equity of $6 million or more. The NYSE American’s review showed that we were not in compliance with that requirement. We submitted a plan (the “Plan”) to the NYSE American detailing actions we would take to regain compliance by June 11, 2026. The NYSE American accepted our Plan on February 26, 2025. If we had been unable to regain compliance by June 11, 2026, our common stock was subject to delisting from the NYSE American. As of September 30, 2026, our stockholders’ equity was $7.1 million.
Previous wording
On April 30, 2025, the Company held a special meeting of stockholders and authorized the Company’s Board of Directors to effect a reverse split at its discretion on a basis of up to one for 100 outstanding shares of Common Stock. On May 29, 2025, the Board authorized the Reverse Split and on June 10, 2025, the Company filed an amendment to its Articles of Incorporation effecting a reverse split of its outstanding shares of Common Stock on a one for 100 basis (the “Reverse Split”). Stockholders were given cash in lieu of any fractional shares on a post-split basis.
Current wording
On April 30, 2025, the Company held a special meeting of stockholders and authorized the Company’s Board of Directors to effect a reverse split at its discretion on a basis of up to one for 100 outstanding shares of Common Stock. On May 29, 2025, the Board authorized the Reverse Split and on June 10, 2025, the Company filed an amendment to its Certificate of Incorporation effecting a reverse split of its outstanding shares of Common Stock on a one for 100 basis (the “Reverse Split”). Stockholders were given cash in lieu of any fractional shares on a post-split basis.
Previous wording
We entered into an amendment to a Promissory Note with our Lender on March 10, 2026. The maturity date for the Note was extended until June 30, 2026, and then further extended to June 30, 2027. Other than the maturity date extension, there were no other changes to the agreement.
Current wording
We entered into an amendment to a Promissory Note with our Lender on March 10, 2026. The maturity date for the Note was extended until June 30, 2026, and then further extended to June 30, 2027. Other than the maturity date extension, the amendment made no other changes to the Promissory Note.
Previous wording
As a research and development company, we are conducting research necessary to bring our product, Ampligen, to market. As such, we primarily rely on financing activities to provide the necessary funding to meet our obligations as they become due. AIM has a long and demonstrated history of success in these efforts, however, there is no assurance that we will be successful in attaining the necessary funding in the future.
Current wording
As a research and development company, we are conducting research necessary to bring our product, Ampligen, to market. As such, we primarily rely on financing activities to provide the necessary funding to meet our obligations as they become due. There is no assurance that we will be successful in attaining the necessary funding in the future. We are also committed to identifying senior co-development partners with capital and commercialization expertise.
Previous wording
The development of our products requires the commitment of substantial resources to conduct time-consuming research, preclinical development, and clinical trials that are necessary to bring pharmaceutical products to market. We believe, based on our current financial condition, that we do not have adequate funds to meet our anticipated operational cash needs and fund current clinical trials. At present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future. We will need to obtain additional funding in the future to continue operations and for new studies and/or if current studies do not yield positive results, require unanticipated changes and/or additional studies.
Current wording
The development of our products requires the commitment of substantial resources to conduct time-consuming research, preclinical development, and clinical trials that are necessary to bring pharmaceutical products to market. We believe, based on our current financial condition, that we do not have adequate funds to meet our anticipated operational cash needs and fund current clinical trials. As discussed in Note 1 to our condensed consolidated financial statements, these conditions raise substantial doubt about our ability to continue as a going concern within one year after the date that the condensed consolidated financial statements included in this Report are issued. At present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future. We will need to obtain additional funding in the future to continue operations and for new studies and/or if current studies do not yield positive results, require unanticipated changes and/or additional studies.
Previous wording
Over the next 12 months, we anticipate that our primary cash requirements will include funding ongoing clinical trials for pancreatic cancer, general and administrative expenses, and debt service obligations. As of June 30, 2026, we had approximately $10.0 million in cash, cash equivalents, and marketable securities. We estimate that our short-term (annual) working capital requirements currently range between $7.2 million and $10.8 million depending on the progress of clinical trials and financing sources.
Current wording
Over the next 12 months, we anticipate that our primary cash requirements will include funding ongoing clinical trials for pancreatic cancer, general and administrative expenses, payments under the Sterling Proposal Agreement (estimated at approximately $1.5 million over the 12 months following July 31, 2026), operating lease payments, and debt service obligations under the Streeterville note dated November 18, 2025 (approximately $1.7 million of principal outstanding as of September 30, 2026). As of September 30, 2026, we had approximately $6.9 million in cash, cash equivalents, and marketable securities. We estimate that our short-term (annual) working capital requirements currently range between $7.2 million and $10.8 million depending on the progress of clinical trials and financing sources. Accordingly, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations only into 2027, and we will need to raise additional capital to fund our operations beyond that date.
Rearranged previous paragraphs (16)
Previous report — wording carried elsewhere
The Company’s net loss for the quarter ended June 30, 2026 was $3.8 million compared with a net loss of $2.8 million for the quarter ended June 30, 2025, an increase of $1.0 million. The increase in net loss was primarily attributable to offering related costs incurred in connection with multiple equity transactions completed during the quarter, including placement agent fees, legal fees, accounting fees, and other direct transaction costs, as discussed below.
Previous report — wording carried elsewhere
On May 7-8, 2026, the Company entered into inducement letter agreements with eight existing warrant holders pursuant to which such holders agreed to immediately exercise an aggregate of 7,451,920 previously outstanding Class A through Class F Warrants at an exercise price of $0.48 per share, generating gross proceeds to the Company of approximately $3.6 million. In connection with the inducement, the Company reduced the exercise price of the outstanding Class A through Class F Warrants to $0.48 per share. In consideration for the immediate exercises, the Company issued to such holders an aggregate of 14,903,840 new Class H Common Stock Purchase Warrants with an exercise price of $0.60 per share and a five-year term commencing on the Stockholder Approval Date. In connection with the inducement transaction, the Company also issued 447,116 Placement Agent Warrants to Ladenburg Thalmann & Co., Inc. with an exercise price of $0.60 per share and a five-year term commencing on the issue date, issued pursuant to the Investment Banking Agreement dated April 9, 2026. The Class H Warrants and Class H Placement Agent Warrants are equity-classified. The Class H Warrants are not exercisable until the Company obtains stockholder approval (See Note 17: Subsequent Events) and include a beneficial ownership limitation of 4.99%, or 9.99% upon election, customary anti-dilution adjustments, cashless exercise rights if there is no effective registration statement or available prospectus for resale of the underlying shares, and fundamental transaction provisions.
Previous report — wording carried elsewhere
The Company evaluated the temporary reduction in the exercise price of the Class A through Class F Warrants as a modification of freestanding equity-classified written call options. The incremental fair value effect of the modification was approximately $8,235 based on a class-by-class analysis and was attributable to the Class A and Class C Warrants. The aggregate fair value of the new Class H Warrants issued to the exercising holders was approximately $6.6 million. Accordingly, the aggregate value transferred to the exercising warrant holders was approximately $6.6 million.
Previous report — wording carried elsewhere
The Company also incurred approximately $561 thousand of placement-agent costs in connection with the transaction, consisting of approximately $363 thousand of cash placement-agent fees and approximately $198 thousand representing the fair value of the Class H Placement Agent Warrants. Total holder-side consideration and placement-agent costs associated with the transaction were therefore approximately $7.2 million.
Previous report — wording carried elsewhere
The transaction generated gross exercise proceeds of approximately $3.6 million. The Company recognized equity issuance costs equal to the gross proceeds of the transaction, consisting of approximately $561 thouand of placement-agent costs and approximately $3.0 million of holder-side inducement consideration. The remaining approximately $3.6 million of value transferred to the exercising warrant holders exceeded the proceeds available to absorb the transaction costs and was recognized as a deemed dividend. Because the Company had an accumulated deficit, the deemed dividend was recorded as a reduction of additional paid-in capital.
Previous report — wording carried elsewhere
The deemed dividend did not affect the Company’s net loss or total stockholders’ equity but was deducted in determining net loss available to common stockholders for purposes of calculating basic earnings per share. The noncash entries associated with the Class H Warrants, the Existing Warrant modification, and the Class H Placement Agent Warrants also had no net effect on total stockholders’ equity. After payment of the cash placement-agent costs, the transaction increased total stockholders’ equity by approximately $3.2 million, representing the net cash proceeds received
Previous report — wording carried elsewhere
At June 30, 2026 447,116 Placement Agent Warrants and 14,903,840 Class H Warrants were outstanding.
Previous report — wording carried elsewhere
On May 21, 2026, the Company closed a registered direct offering (the ‘May 2026 Class I Offering’) of 7,519,351 registered shares of common stock and Class I Common Stock Purchase Warrants to purchase up to 15,038,702 shares of common stock at an exercise price of $0.325 per share, exercisable for a five-year period commencing on the Stockholder Approval Date.
Previous report — wording carried elsewhere
The combined offering price was $0.325 per share of common stock and accompanying Class I Warrants. Although the Class I Securities Purchase Agreement permitted each Purchaser to elect Pre-Funded Warrants in lieu of common stock, no Purchaser elected to receive Pre-Funded Warrants at closing, and consequently no May 2026 Pre-Funded Warrants were issued. Gross proceeds to the Company totaled approximately $2.4 million.
Previous report — wording carried elsewhere
Ladenburg Thalmann & Co., Inc. acted as the placement agent for the May 2026 Class I Offering and received an 8.0% cash commission of approximately $196 thousand, a 0.75% management fee of approximately $18 thousand, reimbursement of expenses of $100 thousand, and 451,161 Placement Agent Warrants exercisable at approximately $0.41 per share (125% of the offering price) for a five-year period from the effective date of the Registration Statement. The Class I Warrants and Class I Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds between the common stock and the Class I Warrants, resulting in allocations of approximately $939 thousand to common stock and $1.5 million to Class I Warrants. The Class I Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder meeting to be held no later than July 21, 2026. (See Note 17: Subsequent Events)
Previous report — wording carried elsewhere
On June 10, 2026, the Company closed a registered direct offering and concurrent private placement (the “June 2026 Class J Offering”) of 2,554,119 registered shares of common stock, 771,503 unregistered shares of common stock, Pre-Funded Warrants to purchase up to 1,782,616 shares of common stock at a nominal exercise price of $0.001 per share (fully pre-funded at closing), and Class J Common Stock Purchase Warrants to purchase up to 10,216,476 shares of common stock at an exercise price of approximately $0.52 per share, exercisable for a five-year period commencing on the Stockholder Approval Date.
Previous report — wording carried elsewhere
Ladenburg Thalmann & Co., Inc. acted as the placement agent for the June 2026 Class J Offering and received an 8.0% cash commission of approximately $212 thousand, a 0.75% management fee of approximately $20 thousand, reimbursement of expenses of $100 thousand, and 306,494 Placement Agent Warrants exercisable at approximately $0.65 per share with a five-year term. The Class J Warrants, June 2026 Pre-Funded Warrants, and Class J Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds among the common stock, Pre-Funded Warrants, and Class J Warrants. The Class J Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder meeting to be held no later than July 21, 2026 (concurrent with the Class I and Class H Warrants). (See Note 17: Subsequent Events)
Previous report — wording carried elsewhere
For the three months ended June 30, 2026, prefunded warrants were exercised for 1,300,828 shares of common stock. At June 30, 2026 481,788 Pre-Funded Warrants, 306,494 Placement Agent Warrants and 10,216,476 Class J Warrants were outstanding.
Previous report — wording carried elsewhere
Interest expense was $599 thousand and $273 thousand for the six months ended June 30, 2026 and 2025, respectively. The increase in interest expense is due to additional debt. On November 18, 2025, the Company (“Borrower”) entered into a Note Purchase Agreement with Streeterville Capital LLC (“Streeterville” or the “Lender”). Under the terms of the agreement, Streeterville paid the Company $2.5 million in exchange for an unsecured promissory Note with an Original Issue Discount of $781 thousand. The Company will pay $3.3 million consisting of the principal amount of the Note, together with the original issue discount and $20 thousand of lender transaction fees, no later than November 18, 2027. The stated interest rate of the note is 10%.
Previous report — wording carried elsewhere
On June 10, 2026, the Company issued and sold 2,554,119 shares of common stock and, in a concurrent private placement, 771,503 shares of common stock, pre-funded warrants to purchase up to 1,782,616 shares of common stock, and Class J warrants to purchase up to 10,216,476 shares of common stock to certain investors for aggregate gross proceeds of approximately $2.6 million
Previous report — wording carried elsewhere
On May 21, 2026, the Company issued and sold 7,519,351 shares of common stock, par value $0.001 per share, and, in a concurrent private placement, Class I warrants to purchase up to 15,038,702 shares of common stock to certain investors for aggregate gross proceeds of approximately $2.4 million.