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IGC Pharma, Inc.

For the period ended Sep 30, 2026. Filed Nov 6, 2026.

View on SEC.gov

About 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 6, 2026

IGC$0.20+5.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-14.

0001185185-26-003544

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-06.

0001185185-26-005237

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 86 previous paragraphs and 90 current paragraphs.

54 unchanged; 22 reworded; 12 added; 10 removed; 0 previous and 2 current paragraphs rearranged.

Tables are not compared: 20 previous and 14 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 (12)

Current report

During the three months ended September 30, 2026, the Company completed enrollment in its CALMA Phase 2 clinical trial and continued clinical trial activities in preparation for the completion of the treatment period and subsequent data analysis.

Current report

Following the protocol-defined six-week treatment period, final participant dosing is expected to conclude mid-November 2026, after which the Company expects to proceed with database lock, unblinding, and topline analysis. The Company anticipates reporting topline results during the December 2026/January 2027 timeframe, subject to clinical trial and data management uncertainties.

Current report

Revenue– Revenue increased by approximately $137 thousand, or 72%, to approximately $328 thousand for the three months ended September 30, 2026, from approximately $191 thousand for the three months ended September 30, 2025, primarily due to higher white label revenue of approximately $321 thousand compared with approximately $153 thousand. Revenue in both periods was derived from our Life Sciences segment.

Current report

Cost of revenue – Cost of revenue was approximately $267 thousand for the three months ended September 30, 2026, compared with approximately $92 thousand for the three months ended September 30, 2025, and gross margin decreased to 19% from 52%. The decrease in gross margin was primarily due to the transition of production to third-party manufacturers following the 2025 sale of our Vancouver, Washington manufacturing operations. Cost of revenue consists primarily of raw materials, labor and other direct costs. Gross margin may fluctuate based on product mix and is expected to remain below historical levels in the near term.

Current report

Research and Development expenses (“R&D”)– R&D expenses were attributed to our Life Sciences segment. The R&D expenses decreased by approximately $575 thousand, or 36%, to approximately $1.0 million for the three months ended September 30, 2026, from approximately $1.6 million for the three months ended September 30, 2025. The decrease was primarily due to lower clinical trial costs of approximately $362 thousand, because site activation for the Phase 2 CALMA trial was largely completed in the first six months of 2026 and costs in the third quarter related mainly to patient enrollment, and lower non-cash stock-based compensation of approximately $213 thousand. R&D expenses relate primarily to the Phase 2 CALMA trial of IGC-AD1 and preclinical studies of TGR-63.

Current report

Revenue– Revenue increased by approximately $61 thousand, or 7%, to approximately $910 thousand for the nine months ended September 30, 2026, from approximately $849 thousand for the nine months ended September 30, 2025, primarily due to higher white label revenue of approximately $871 thousand compared with approximately $793 thousand. Revenue in both periods was derived from our Life Sciences segment.

Current report

Cost of revenue – Cost of revenue was approximately $746 thousand for the nine months ended September 30, 2026, compared with approximately $442 thousand for the nine months ended September 30, 2025, and gross margin decreased to 18% from 48%, primarily due to the transition of production to third-party manufacturers following the 2025 sale of our Vancouver, Washington manufacturing operations.

Current report

Research and Development expenses (“R&D”)– R&D expenses were attributed to our Life Sciences segment. The R&D expenses increased by approximately $239 thousand, or 7%, to approximately $3.7 million for the nine months ended September 30, 2026, from approximately $3.4 million for the nine months ended September 30, 2025. The increase was primarily due to higher clinical trial costs of approximately $87 thousand, mainly for site activation for the Phase 2 CALMA trial in the first six months of 2026, and higher non-cash stock-based compensation of approximately $236 thousand, partially offset by lower other operating expenses.

Current report

Other (expense)/income, net – Other (expense)/income, net was an expense of approximately $211 thousand for the nine months ended September 30, 2026, compared with income of approximately $1.6 million for the nine months ended September 30, 2025. The change was primarily due to two items in the nine months ended September 30, 2025 that did not recur: the gain of approximately $1.1 million on the sale of our Vancouver, Washington manufacturing operations and tax credits of approximately $465 thousand, and approximately $188 thousand of amortization of debt discount on the loans in the nine months ended September 30, 2026, partially offset by a gain of approximately $40 thousand from the change in fair value of the derivative liability.

Current report

During the three months ended September 30, 2026, the Company settled approximately $586 thousand of accrued officers’ compensation in shares, and approximately $568 thousand of officers’ loans and advances is to be settled in shares. For more information, please refer to Note 11, “Loans and Other liabilities”.
Removed paragraphs (10)

Previous report

Clinical trial activities are subject to inherent uncertainties, including patient enrollment rates, protocol adherence, regulatory oversight, and data integrity, any of which could materially affect trial timelines or results. During the quarter ended June 30, 2026, the Company reached its previously disclosed target enrollment of 146 patients, with 146 participants randomized at baseline; the CALMA trial remains ongoing, with limited over-enrollment and patient follow-up activities continuing.

Previous report

Revenue– Revenue was approximately $265 thousand and $328 thousand for the three months ended June 30, 2026, and June 30, 2025, respectively. Revenue in both periods was primarily derived from our Life Sciences segment, encompassing the sale of our formulations as white-labeled manufactured products, among others. There is a decrease in revenue as our core focus is on advancing IGC-AD1, completing the Phase 2 trial, and developing MINT-AD for the early diagnosis of Alzheimer’s disease.

Previous report

Cost of revenue – Cost of revenue amounted to approximately $217 thousand for the three months ended June 30, 2026, compared to $174 thousand in the three months ended June 30, 2025. This represents gross margins of 18% and 47%, respectively. The cost of revenue is primarily attributable to the cost of raw materials, labor, and other direct overheads required to produce our products in the Life Sciences segment. Typically, the gross margin in the Life Sciences business will fluctuate from one quarter to the next based on the mix among white-label, private-label, and branded products. There is insufficient revenue to model or project gross margins. In the near term, the Company expects gross margins to remain lower than historical levels as operations stabilize and supply chain arrangements are transitioned to third-party manufacturers. While the transition may result in a temporary reduction in gross margins, management believes the transaction provides long-term operational efficiencies and improved financial flexibility.

Previous report

Research and Development expenses (“R&D”)– R&D expenses were attributed to our Life Sciences segment. The R&D expenses increased by approximately $539 thousand, or 63%, to approximately $1.4 million during the three months ended June 30, 2026, from approximately $851 thousand during the three months ended June 30, 2025. The R&D expenses are primarily attributed to the progression of Phase 2 trials on IGC-AD1 and preclinical studies on TGR-63, indicating the Company’s dedication to advancing its product pipeline. As the development of TGR-63 and the Phase 2 trial on Alzheimer’s gains momentum, the Company anticipates an increase in R&D expenses.

Previous report

Results of Operations for the Six Months Ended June 30, 2026, and June 30, 2025

Previous report

Revenue– Revenue was approximately $582 thousand and $658 thousand for the six months ended June 30, 2026, and June 30, 2025, respectively. Revenue in both periods was primarily derived from our Life Sciences segment, encompassing the sale of our formulations as white-labeled manufactured products, among others. There is a decrease in revenue as our core focus is on advancing IGC-AD1, completing the Phase 2 trial, and developing MINT-AD for the early diagnosis of Alzheimer’s disease.

Previous report

Cost of revenue – Cost of revenue amounted to approximately $479 thousand for the six months ended June 30, 2026, compared to $350 thousand in the six months ended June 30, 2025. This represents gross margins of 18% and 47%, respectively. The cost of revenue is primarily attributable to the cost of raw materials, labor, and other direct overheads required to produce our products in the Life Sciences segment. Typically, the gross margin in the Life Sciences business will fluctuate from one quarter to the next based on the mix among white-label, private-label, and branded products. There is insufficient revenue to model or project gross margins. In the near term, the Company expects gross margins to remain lower than historical levels as operations stabilize and supply chain arrangements are transitioned to third-party manufacturers. While the transition may result in a temporary reduction in gross margins, management believes the transaction provides long-term operational efficiencies and improved financial flexibility.

Previous report

Research and Development expenses (“R&D”)– R&D expenses were attributed to our Life Sciences segment. The R&D expenses increased by approximately $814 thousand, or 44%, to approximately $2.7 million during the six months ended June 30, 2026, from approximately $1.8 million, during the six months ended June 30, 2025. The R&D expenses are primarily attributed to the progression of Phase 2 trials on IGC-AD1 and preclinical studies on TGR-63, indicating the Company’s dedication to advancing its product pipeline. As the development of TGR-63 and the Phase 2 trial on Alzheimer’s gains momentum, the Company anticipates an increase in R&D expenses.

Previous report

Other (expense)/income, net – The Company recorded other expense, net, of approximately $96 thousand for the six months ended June 30, 2026, compared to other income, net, of approximately $521 thousand for the six months ended June 30, 2025, a decrease of approximately $617 thousand, or 118%. Other income consists of interest and rental income, dividend income, gains on the sale of assets, unrealized gains on investments, net, and income from scrap sales. Other expense consists of interest, amortization of debt discount and issuance costs, and non-operational one-time items. The change is primarily attributable to approximately $133 thousand of interest and amortization expense on outstanding loans during the six months ended June 30, 2026, and approximately $457 thousand of tax credits received during the six months ended June 30, 2025.

Previous report

On June 30, 2026, the Company entered into separate Stock Purchase Agreements with Mr. Ram Mukunda and Ms. Claudia Grimaldi covering outstanding amounts aggregating $1,154,210. Pursuant to the Stock Purchase Agreements, the Company approved the future issuance of an aggregate of 4,274,853 shares of common stock at $0.27 per share. The transaction was noncash, and the aggregate amount was classified within stockholders’ equity as common stock subscribed but not yet issued. As of June 30, 2026, the shares had not been issued, delivered, credited to the respective individuals’ accounts, or reflected as issued and outstanding in the Company’s stock ledger. Accordingly, the shares did not increase the Company’s issued and outstanding common stock as of June 30, 2026. For more information, please refer to Note 11, “Loans and other liabilities” and Note 13, “Securities.”
Reworded paragraphs (22)

Previous wording

The purpose of this Management’s Discussion and Analysis (“MD&A”) is to provide an understanding of IGC Pharma, Inc.’s (“IGC,” “IGC Pharma,” the “Company,” “we,” “our,” and/or “us”) consolidated financial condition and results of operations and cash flows. The MD&A should be read in conjunction with our unaudited condensed financial statements and related notes that appear elsewhere in this Quarterly Report on Form 10-Q for the three and six months ended June 30, 2026, and in the Transition Report on Form 10-KT for the nine months ended December 31, 2025, filed with the SEC on March 18, 2026 (the “2025 Form 10-KT”). The Company’s actual results could differ materially from those discussed here. Factors that could cause differences include those discussed in the “Forward-Looking Statements” and “Risk Factors” sections and discussed elsewhere in this report. The risks and uncertainties can cause actual results to differ significantly from those in our forward-looking statements or implied in historical results and trends. Accordingly, we caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as expressly required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those outlined in the forward-looking statements.

Current wording

The purpose of this Management’s Discussion and Analysis (“MD&A”) is to provide an understanding of IGC Pharma, Inc.’s (“IGC,” “IGC Pharma,” the “Company,” “we,” “our,” and/or “us”) consolidated financial condition and results of operations and cash flows. The MD&A should be read in conjunction with our unaudited condensed financial statements and related notes that appear elsewhere in this Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2026, and in the Transition Report on Form 10-KT for the nine months ended December 31, 2025, filed with the SEC on March 18, 2026 (the “2025 Form 10-KT”). The Company’s actual results could differ materially from those discussed here. Factors that could cause differences include those discussed in the “Forward-Looking Statements” and “Risk Factors” sections and discussed elsewhere in this report. The risks and uncertainties can cause actual results to differ significantly from those in our forward-looking statements or implied in historical results and trends. Accordingly, we caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as expressly required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those outlined in the forward-looking statements.

Previous wording

Our lead product candidate,IGC-AD1, is currently being evaluated in the CALMA, a randomized, double-blind, placebo-controlled Phase 2 clinical trial for the treatment of agitation in Alzheimer’s dementia, a neuropsychiatric condition affecting a substantial proportion of patients and associated with significant patient distress, caregiver burden, and healthcare utilization. In addition to symptom management, preclinical studies of IGC-AD1 suggest activity against biological pathways associated with Alzheimer’s disease pathology, supporting its potential evaluation in broader disease-modifying contexts. As of June 30, 2026, the CALMA trial had reached the Company’s previously disclosed target enrollment of 146 patients, with 146 participants randomized at baseline. The Company continued limited over-enrollment and patient follow-up activities intended to address potential attrition and support the planned clinical analyses. Following completion of these activities, the Company expects to proceed with database activities, site closeout, and topline analysis. The trial remains ongoing, and there can be no assurance regarding its results, future development, or regulatory approval.

Current wording

Our lead product candidate,IGC-AD1, is currently being evaluated in the CALMA, a randomized, double-blind, placebo-controlled Phase 2 clinical trial for the treatment of agitation in Alzheimer’s dementia, a neuropsychiatric condition affecting a substantial proportion of patients and associated with significant patient distress, caregiver burden, and healthcare utilization. In addition to symptom management, preclinical studies of IGC-AD1 suggest activity against biological pathways associated with Alzheimer’s disease pathology, supporting its potential evaluation in broader disease-modifying contexts.

Previous wording

The Company is also developingMINT-AD, a proprietary, artificial intelligence, enabled data platform designed to support risk stratification and longitudinal assessment in Alzheimer’s disease using multimodal datasets. MINT-AD is intended as a clinical and research decision-support tool and is not currently approved as a diagnostic device. As of June 2026, the Company announced the beta version of AHA. MINT-AD and AHA remain under development and have not been approved or cleared as diagnostic or therapeutic products.

Current wording

The Company is also developingMINT-AD, a proprietary, artificial intelligence, enabled data platform designed to support risk stratification and longitudinal assessment in Alzheimer’s disease using multimodal datasets. MINT-AD is intended as a clinical and research decision-support tool and is not currently approved as a diagnostic device. On June 23, 2026, the Company announced the beta version of AHA. MINT-AD and AHA remain under development and have not been approved or cleared as diagnostic or therapeutic products.

Previous wording

IGC Pharma, a clinical-stage company developing treatments for Alzheimer’s disease, is committed to transforming patient care by striving to offer faster acting and more effective solutions. Our lead drug, IGC-AD1, embodies this vision by tackling a critical challenge – managing agitation in Alzheimer’s dementia. In a previously completed early-stage study, IGC-AD1 was associated with reductions in agitation scores relative to placebo, including observations within two weeks. That study was not designed to establish comparative onset versus approved therapies, and the ongoing CALMA Phase 2 trial has not been unblinded or completed. Interim and blinded observations are preliminary, are not statistically powered to establish efficacy, and may not be predictive of topline or final results. While existing anti-psychotics can take as long as 6 to 12 weeks to show effects; we believe IGC-AD1 has the potential to act within two weeks. This potentially faster onset of action could significantly improve patient care and represents a potential breakthrough in managing Alzheimer’s-related agitation, although there can be no assurance thereof. In addition, we have created in-house wellness brands, available through online channels that are compliant with relevant federal, state, and local laws and regulations. We derive revenue from our in-house wellness non-pharmaceutical formulations that are sold over-the counter (“OTC”). As of June 30, 2026, CALMA had reached the Company’s previously disclosed target enrollment of 146 patients, with 146 participants randomized at baseline. The Company continued limited over-enrollment and patient follow-up activities intended to account for potential attrition and support a high-quality evaluable dataset as the trial advances toward completion and topline analysis.

Current wording

IGC Pharma, a clinical-stage company developing treatments for Alzheimer’s disease, is committed to transforming patient care by striving to offer faster acting and more effective solutions. Our lead drug, IGC-AD1, embodies this vision by tackling a critical challenge – managing agitation in Alzheimer’s dementia. In a previously completed early-stage study, IGC-AD1 was associated with reductions in agitation scores relative to placebo, including observations within two weeks. That study was not designed to establish comparative onset versus approved therapies, and the ongoing CALMA Phase 2 trial has not been unblinded or completed. Interim and blinded observations are preliminary, are not statistically powered to establish efficacy, and may not be predictive of topline or final results. While existing anti-psychotics can take as long as 6 to 12 weeks to show effects; we believe IGC-AD1 has the potential to act within two weeks. This potentially faster onset of action could significantly improve patient care and represents a potential breakthrough in managing Alzheimer’s-related agitation, although there can be no assurance thereof. In addition, we have created in-house wellness brands, available through online channels that are compliant with relevant federal, state, and local laws and regulations. We derive revenue from our in-house wellness non-pharmaceutical formulations that are sold over-the counter (“OTC”).

Previous wording

The Company is developing a proprietary Multimodal Interpretable Transformer for Alzheimer’s Disease (“MINT-AD”). MINT-AD is an artificial intelligence (“AI”) platform designed to enhance the detection and management of Alzheimer’s disease (“AD”) by providing clinicians with scalable, interpretable, and predictive diagnostic support. The platform is engineered to transition AD diagnostics from specialized, high-cost environments—such as neurology clinics utilizing Positron Emission Tomography (“PET”) scans—to primary care settings, rural areas, and underserved populations, although there is no assurance we will be successful in this regard. MINT-AD is intended as a clinical and research decision-support tool and is not currently approved as a diagnostic device. In addition, the Company is developing the Agentic Harmonization Assistant (“AHA”), a proprietary artificial intelligence-enabled platform designed to assist with the harmonization and analysis of fragmented biomedical datasets. As of June 2026, the Company announced the beta version of AHA. MINT-AD and AHA remain under development and have not been approved or cleared as diagnostic or therapeutic products.

Current wording

The Company is developing a proprietary Multimodal Interpretable Transformer for Alzheimer’s Disease (“MINT-AD”). MINT-AD is an artificial intelligence (“AI”) platform designed to enhance the detection and management of Alzheimer’s disease (“AD”) by providing clinicians with scalable, interpretable, and predictive diagnostic support. The platform is engineered to transition AD diagnostics from specialized, high-cost environments—such as neurology clinics utilizing Positron Emission Tomography (“PET”) scans—to primary care settings, rural areas, and underserved populations, although there is no assurance we will be successful in this regard. MINT-AD is intended as a clinical and research decision-support tool and is not currently approved as a diagnostic device. In addition, the Company is developing the Agentic Harmonization Assistant (“AHA”), a proprietary artificial intelligence-enabled platform designed to assist with the harmonization and analysis of fragmented biomedical datasets. On June 23, 2026, the Company announced the beta version of AHA. MINT-AD and AHA remain under development and have not been approved or cleared as diagnostic or therapeutic products.

Previous wording

Selling, General and Administrative expenses (“SG&A”)– SG&A expenses primarily encompass various costs such as employee-related expenses, sales commissions, professional fees, legal fees, marketing expenses, other corporate expenses, allocated general overhead, provisions, depreciation, and write-offs related to doubtful accounts and advances. During the three months ended June 30, 2026, SG&A expenses increased by approximately $234 thousand, or 19%, to approximately $1.4 million as compared to approximately $1.2 million during the three months ended June 30, 2025. The increase of $234 thousand is attributed to the increase of approximately $273 thousand related to non-cash expense, which was offset by decreases of approximately $39 thousand in operating expenses.

Current wording

Selling, General and Administrative expenses (“SG&A”)– SG&A expenses primarily encompass various costs such as employee-related expenses, sales commissions, professional fees, legal fees, marketing expenses, other corporate expenses, allocated general overhead, provisions, depreciation, and write-offs related to doubtful accounts and advances. During the three months ended September 30, 2026, SG&A expenses decreased by approximately $431 thousand, or 31%, to approximately $979 thousand from approximately $1.4 million for the three months ended September 30, 2025, primarily due to lower stock-based compensation of approximately $127 thousand and lower other operating expenses of approximately $304 thousand, including lower depreciation and manufacturing running costs following the 2025 sale of our Vancouver, Washington manufacturing operations.

Previous wording

Other (expense)/income, net – The Company recorded other expense, net, of approximately $152 thousand for the three months ended June 30, 2026, compared to other income, net, of approximately $306 thousand for the three months ended June 30, 2025, a decrease of approximately $458 thousand, or 150%. Other income consists of interest and rental income, dividend income, gains on the sale of assets, unrealized gains on investments, net, and income from scrap sales. Other expense consists of interest, amortization of debt discount and issuance costs, and non-operational one-time items. The change is primarily attributable to approximately $120 thousand of interest and amortization expense on outstanding loans during the three months ended June 30, 2026, and approximately $263 thousand of tax credits received during the three months ended June 30, 2025.

Current wording

*Other (expense)/income, net –*Other (expense)/income, net was an expense of approximately $115 thousand for the three months ended September 30, 2026, compared with income of approximately $1.1 million for the three months ended September 30, 2025. The change was primarily due to the gain of approximately $1.1 million on the sale of our Vancouver, Washington manufacturing operations in the three months ended September 30, 2025, which did not recur, and interest and amortization of debt discount and issuance costs on the Loans in the three months ended September 30, 2026. Other income consists of interest and rental income, dividend income, gains on the sale of assets, unrealized gains on investments and income from scrap sales.

Previous wording

The historical results presented below are not necessarily indicative of the results that may be expected for any future period. The following table presents an overview of our results of operations for the six months ended June 30, 2026, and June 30, 2025:

Current wording

The historical results presented below are not necessarily indicative of the results that may be expected for any future period. The following table presents an overview of our results of operations for the nine months ended September 30, 2026, and September 30, 2025:

Previous wording

Selling, General and Administrative expenses (“SG&A”)– SG&A expenses primarily encompass various costs such as employee-related expenses, sales commissions, professional fees, legal fees, marketing expenses, other corporate expenses, allocated general overhead, provisions, depreciation, and write-offs related to doubtful accounts and advances. During the six months ended June 30, 2026, SG&A expenses increased by approximately $905 thousand, or 51%, to approximately $2.7 million as compared to approximately $1.8 million during the six months ended June 30, 2025. The increase of $905 thousand is attributed to the absence of a $700 thousand credit recognized in the prior period related to the conversion of accrued cash bonuses into performance-based compensation by the Board of Directors. In addition, the increase of approximately $401 thousand related to non-cash expense was offset by decreases of approximately $196 thousand in operating expenses.

Current wording

Selling, General and Administrative expenses (“SG&A”)– SG&A expenses primarily encompass various costs such as employee-related expenses, sales commissions, professional fees, legal fees, marketing expenses, other corporate expenses, allocated general overhead, provisions, depreciation, and write-offs related to doubtful accounts and advances. During the nine months ended September 30, 2026, SG&A expenses increased by approximately $474 thousand, or 15%, to approximately $3.7 million from approximately $3.2 million for the nine months ended September 30, 2025, primarily due to the absence of a credit of approximately $700 thousand recognized in the prior-year period upon the conversion of accrued cash bonuses into performance-based compensation and higher stock-based compensation of approximately $273 thousand, partially offset by lower other operating expenses of approximately $499 thousand, including lower depreciation and manufacturing running costs following the 2025 sale of our Vancouver, Washington manufacturing operations.

Previous wording

On October 27, 2023, the Company entered into a Sales Agreement (the “Sales Agreement”) with A.G.P./Alliance Global Partners (the “Agent”) pursuant to which the Company may offer and sell, from time to time, through the Agent, as sales agent and/or principal, shares of its common stock having an aggregate offering price of up to $60 million, subject to certain limitations on the amount of Common Stock that may be offered and sold by the Company set forth in the Sales Agreement (the “Offering”). As of June 30, 2026, the Company had raised approximately $7.7 million under the $60 million Sales Agreement. The Company is subject to the limitations of Instruction I.B.6 to Form S-3, which limits offerings to one-third of the aggregate market value of the Company’s public float in any 12-month period.

Current wording

On October 27, 2023, the Company entered into a Sales Agreement (the “Sales Agreement”) with A.G.P./Alliance Global Partners (the “Agent”) pursuant to which the Company may offer and sell, from time to time, through the Agent, as sales agent and/or principal, shares of its common stock having an aggregate offering price of up to $60 million, subject to certain limitations on the amount of Common Stock that may be offered and sold by the Company set forth in the Sales Agreement (the “Offering”). As of September 30, 2026, the Company had raised approximately $9.9 million under the $60 million Sales Agreement. The Company is subject to the limitations of Instruction I.B.6 to Form S-3, which limits offerings to one-third of the aggregate market value of the Company’s public float in any 12-month period.

Previous wording

In addition to it, on February 9, 2026, the Company, through its subsidiary HH Processors, LLC, entered into a loan agreement with ODK Capital LLC (“OnDeck”), pursuant to which the Company received approximately $214 thousand in financing (the “OnDeck Loan”). The OnDeck Loan bears interest and is repayable in periodic installments in accordance with the terms and conditions set forth in the loan agreement, approximately $3 thousand per week. The OnDeck Loan matures in August, 2027.

Current wording

In addition to it, on February 9, 2026, the Company, through its subsidiary HH Processors, LLC, entered into a loan agreement with ODK Capital LLC (“OnDeck”), pursuant to which the Company received approximately $214 thousand in financing (the “OnDeck Loan”). The OnDeck Loan bears interest and is repayable in periodic installments in accordance with the terms and conditions set forth in the loan agreement, approximately $3 thousand per week. The OnDeck Loan matures in August, 2027. For more information, please refer to Note 11, “Loans and Other Liabilities.”

Previous wording

During the six months ended June 30, 2026, the Company issued two promissory notes to VFG with aggregate principal of approximately $591 thousand and received aggregate net proceeds of approximately $470 thousand. The notes mature in February and March 2027 and are convertible upon specified events of default at variable conversion prices, subject to applicable ownership and exchange limitations. The related conversion features were accounted for as derivative liabilities under ASC 815. For more information, please refer to Note 11, “Loans and Other Liabilities.”

Current wording

During the nine months ended September 30, 2026, the Company issued two promissory notes to VFG with aggregate principal of approximately $591 thousand and received aggregate net proceeds of approximately $470 thousand, partially offset by scheduled loan repayments of approximately $308 thousand. The aggregate principal of approximately $283 thousand remained outstanding as of September 30, 2026. The notes mature in February and March 2027 and are convertible upon specified events of default at variable conversion prices, subject to applicable ownership and exchange limitations. The related conversion features were accounted for as derivative liabilities under ASC 815. For more information, please refer to Note 11, “Loans and Other Liabilities.”

Previous wording

During the transition period ended December 31, 2025, the Company invested approximately $50 thousand in a U.S.-listed digital asset through an ETP, which is approximately valued at $23 thousand as of June 30, 2026. The investment is classified as a current marketable security and is marked to market each period. The Company does not directly hold cryptocurrencies or other digital tokens.

Current wording

During the transition period ended December 31, 2025, the Company invested approximately $50 thousand in a U.S.-listed digital asset through an ETP, which is approximately valued at $36 thousand as of September 30, 2026. The investment is classified as a current marketable security and is marked to market each period. The Company does not directly hold cryptocurrencies or other digital tokens.

Previous wording

Cash and cash equivalents decreased by approximately $569 thousand, or 63%, to $331 thousand as of June 30, 2026, from $900 thousand as of December 31, 2025. The decrease was primarily driven by approximately $2.6 million in cash used in operating activities, and approximately $424 thousand in cash used in investment activities, partially offset by approximately $2.4 million in net proceeds from financing activities. Working capital deficit increased by approximately $1.6 million to $2 million as of June 30, 2026, from approximately $366 thousand as of December 31, 2025. The increase in the working capital deficit was primarily driven by operating cash consumption and current borrowings during the quarter. For more information, please refer to Note 11, “Loans and Other Liabilities”.

Current wording

Cash and cash equivalents decreased by approximately $523 thousand, or 58%, to $377 thousand as of September 30, 2026, from $900 thousand as of December 31, 2025. The decrease was primarily driven by approximately $4 million in cash used in operating activities and approximately $617 thousand in cash used in investing activities, partially offset by approximately $4.1 million in net proceeds from financing activities. Working capital deficit increased by approximately $1.4 million to $1.8 million as of September 30, 2026, from approximately $366 thousand as of December 31, 2025. The increase in the working capital deficit was primarily driven by operating cash consumption and current borrowings during the period. For more information, please refer to Note 11, “Loans and Other Liabilities”.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2026, was approximately $2.6 million. It consists of a net loss of approximately $5.3 million, a positive impact on cash due to non-cash expenses of approximately $2.1 million, and a positive change in operating assets and liabilities of approximately $621 thousand. Non-cash expenses consist of an amortization and depreciation charge of approximately $114 thousand, stock-based expenses of approximately $1.8 million, and other items of approximately $274 thousand. In addition, changes in operating assets and liabilities had a positive impact of approximately $621 thousand on cash, of which a positive impact of approximately $604 thousand is due to an increase in accounts payable, a positive impact of approximately $53 thousand is due to a positive increase in accrued and other liabilities, partially offset by approximately $44 thousand is due to an increase in accounts receivable and net other current assets and liabilities of approximately $8 thousand.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2026, was approximately $4.0 million. It consists of a net loss of approximately $7.4 million, a positive impact on cash due to non-cash expenses of approximately $2.6 million, and a positive change in operating assets and liabilities of approximately $748 thousand. Non-cash expenses consist of a depreciation and amortization charge of approximately $172 thousand, stock-based expenses of approximately $2.1 million, and other items of approximately $328 thousand. In addition, changes in operating assets and liabilities had a positive impact of approximately $748 thousand on cash, of which a positive impact of approximately $647 thousand is due to an increase in accounts payable, a positive impact of approximately $116 thousand is due to an increase in accrued and other liabilities, partially offset by approximately $55 thousand is due to an increase in accounts receivable, and net other current assets and liabilities of approximately $40 thousand.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2025, was approximately $2.1 million. It consists of a net loss of approximately $2.8 million, a positive impact on cash due to non-cash expenses of approximately $1.3 million, and a negative change in operating assets and liabilities of approximately $672 thousand. Non-cash expenses consist of an amortization and depreciation charge of approximately $295 thousand, stock-based expenses of approximately $907 thousand, an impairment loss of approximately $152 thousand, and an approximately $22 thousand decrease in other non-cash items. In addition, changes in operating assets and liabilities had a negative impact of approximately $672 thousand on cash, of which a net negative impact of approximately $1 million is due to a decrease in accrued and other liabilities, a positive impact of approximately $186 thousand is due to a decrease in deposits and advances, a positive impact of approximately $96 thousand is due to an increase in accounts payable, a positive impact of approximately $84 thousand is due to a decrease in inventory, and net other current assets and liabilities of approximately $8 thousand.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025, was approximately $4.2 million. It consists of a net loss of approximately $4.6 million, a positive impact on cash due to non-cash expenses of approximately $1.1 million, and a negative change in operating assets and liabilities of approximately $735 thousand. Non-cash expenses consist of a depreciation and amortization charge of approximately $414 thousand, stock-based expenses of approximately $1.6 million, an impairment loss of approximately $152 thousand, profit on sale of fixed assets of approximately $1.1 million, and an approximately $13 thousand decrease in other non-cash items. In addition, changes in operating assets and liabilities had a negative impact of approximately $735 thousand on cash, of which a net negative impact of approximately $953 thousand is due to a decrease in accrued and other liabilities, a positive impact of approximately $223 thousand is due to a decrease in deposits and advances, a negative impact of approximately $207 thousand is due to a decrease in accounts payable, a positive impact of approximately $90 thousand is due to a decrease in inventory, a positive impact of approximately $116 thousand is due to a decrease in operating lease assets, and net other current assets and liabilities of approximately $4 thousand.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2026, was approximately $424 thousand, which was comprised of approximately $418 thousand for the acquisition and development of intangible assets, and approximately $6 thousand from the purchase of property, plant, and equipment.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2026, was approximately $617 thousand, which was comprised of approximately $611 thousand for the acquisition and development of intangible assets, and approximately $6 thousand from the purchase of property, plant, and equipment.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2025, was approximately $438 thousand, which was comprised of approximately $262 thousand for the acquisition and development of intangible assets, and approximately $726 thousand of proceeds from the sale of property, plant, and equipment, partially offset by approximately $26 thousand from the purchase of property, plant, and equipment.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2025, was approximately $64 thousand, which was comprised of approximately $559 thousand for the acquisition and development of intangible assets, and approximately $703 thousand of proceeds from the sale of property, plant, and equipment, partially offset by approximately $55 thousand from the purchase of property, plant, and equipment, and approximately $25 thousand for the investment in short-term investments.

Previous wording

Net cash provided by financing activities was approximately $2.4 million for the six months ended June 30, 2026, which was comprised of net proceeds from the issuance of equity stock of approximately $1.1 million and net proceeds from borrowings of approximately $1.3 million, including proceeds from the related-party loan of approximately $377 thousand, proceeds from VFG promissory notes of approximately $470 thousand, proceeds from FirstFire promissory note of approximately $302 thousand and proceeds from the OnDeck loan of approximately $214 thousand, partially offset by scheduled loan repayments of approximately $49 thousand. Please refer to Note 13, “Securities”, and Note 11, “Loans and Other Liabilities”, for more information.

Current wording

Net cash provided by financing activities was approximately $4.1 million for the nine months ended September 30, 2026, which was comprised of net proceeds from the issuance of equity stock of approximately $3.1 million and net proceeds from borrowings of approximately $1.0 million, including proceeds from the related-party loan of approximately $412 thousand, proceeds from VFG promissory notes of approximately $470 thousand, proceeds from FirstFire promissory note of approximately $302 thousand and proceeds from the OnDeck loan of approximately $214 thousand, partially offset by scheduled loan repayments of approximately $392 thousand. Please refer to Note 13, “Securities”, and Note 11, “Loans and Other Liabilities”, for more information.

Previous wording

Net cash provided by financing activities was approximately $1.6 million for the six months ended June 30, 2025, which was comprised of net proceeds from the issuance of equity stock of approximately $1.6 million, partially offset by scheduled loan repayments of approximately $1 thousand. Please refer to Note 13, “Securities”, for more information.

Current wording

Net cash provided by financing activities was approximately $4.8 million for the nine months ended September 30, 2025, which was comprised of net proceeds from the issuance of equity stock of approximately $4.8 million, partially offset by scheduled loan repayments of approximately $2 thousand. Please refer to Note 13, “Securities”, for more information.

Previous wording

During the transition period ended December 31, 2025, the Company invested approximately $50 thousand in a U.S.-listed ETP linked to digital assets as part of an initial assessment of treasury diversification alternatives. As of June 30, 2026, this investment was valued at approximately $23 thousand, reflecting a decline in fair value of approximately $27 thousand. The Company does not currently hold any digital assets directly. Any future treasury allocation decisions will be evaluated in the context of the Company’s liquidity requirements, clinical development milestones, and the availability of capital as described under “Liquidity and Capital Resources” above. Digital asset investments involve significant volatility risk, as discussed in Item 1A — “Risk Factors”.

Current wording

During the transition period ended December 31, 2025, the Company invested approximately $50 thousand in a U.S.-listed ETP linked to digital assets as part of an initial assessment of treasury diversification alternatives. As of September 30, 2026, this investment was valued at approximately $36 thousand, reflecting a decline in fair value of approximately $14 thousand. The Company does not currently hold any digital assets directly. Any future treasury allocation decisions will be evaluated in the context of the Company’s liquidity requirements, clinical development milestones, and the availability of capital as described under “Liquidity and Capital Resources” above. Digital asset investments involve significant volatility risk, as discussed in Item 1A — “Risk Factors”.

Previous wording

During the transition period ended December 31, 2025, the Company invested approximately $50 thousand in a U.S.-listed digital asset through an ETP, which is approximately valued at $23 thousand as of June 30, 2026. The investment is classified as a current marketable security and is marked to market each period. The Company does not directly hold cryptocurrencies or other digital tokens. Holdings in ETPs will be accounted for as equity securities under ASC 321, Investments – Equity Securities, and measured at fair value with changes recognized in earnings. Fair value will be determined using quoted prices in active markets (Level 1 inputs).

Current wording

During the transition period ended December 31, 2025, the Company invested approximately $50 thousand in a U.S.-listed digital asset through an ETP, which is approximately valued at $36 thousand as of September 30, 2026. The investment is classified as a current marketable security and is marked to market each period. The Company does not directly hold cryptocurrencies or other digital tokens. Holdings in ETPs will be accounted for as equity securities under ASC 321, Investments – Equity Securities, and measured at fair value with changes recognized in earnings. Fair value will be determined using quoted prices in active markets (Level 1 inputs).
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

As of September 30, 2026, the Company had completed enrollment in the CALMA Phase 2 clinical trial, with 168 participants randomized, including planned over-enrollment. The trial remains ongoing, and there can be no assurance regarding its results, future development, or regulatory approval.

Current report — wording carried from elsewhere

Results of Operations for the Nine Months Ended September 30, 2026, and September 30, 2025