Skip to main content

AETHLON MEDICAL INC

For the period ended Sep 30, 2025. Filed Nov 12, 2025.

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, 2025 · Filed Nov 12, 2025

AEMD$5.47+3.0%Stored close · as of Nov 6, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

September 30, 2025

  1. NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION

Aethlon Medical, Inc., or Aethlon, the Company, we or us, is a medical therapeutic company focused on developing the Hemopurifier® (HP), a clinical-stage immunotherapeutic device intended for applications in cancer, life-threatening viral infections, and organ transplantation and other areas of significant unmet needs. In human studies (167 sessions with 41 patients), the Hemopurifier was used safely and demonstrated the potential to remove enveloped viruses. In pre-clinical studies, the Hemopurifier has exhibited the capacity to remove harmful extracellular vesicles (EVs) and enveloped viruses from biological fluids, utilizing its proprietary lectin-based mechanism. These extracellular vesicles have been implicated in disease processes such as immune suppression and metastasis in cancer as well as in the progression of severe life-threatening infectious diseases. The U.S. Food and Drug Administration (“FDA”) has designated the Hemopurifier as a “Breakthrough Device” for two independent indications:

·the treatment of individuals with advanced or metastatic cancer who are unresponsive to or intolerant of standard of care therapy, and with cancer types in which extracellular vesicles have been shown to participate in the development or severity of the disease; and
·the treatment of life-threatening viruses for which no approved therapies currently exist.

We are also evaluating the Hemopurifier’s potential in additional clinical contexts based on its mechanism of action and preclinical findings.

Three clinical sites in Australia—Royal Adelaide Hospital in Adelaide, Pindara Private Hospital in the Gold Coast, and GenesisCare North Shore Hospital in Sydney—are currently open for enrollment in our phase 1 oncology trial. As of November 3, 2025, we have treated three participants in the first of three planned treatment cohorts. The Data Safety Monitoring Board (DSMB), comprising independent medical experts in nephrology and oncology, has reviewed the data from the initial cohort. Each of the three participants received a single 4-hour Hemopurifier treatment. Based on their evaluation, the DSMB found no safety concerns and confirmed that the Hemopurifier continues to demonstrate a favorable safety and tolerability profile. To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been reported.

Enrollment for Cohort 2 is now open. In this phase, participants will receive two Hemopurifier treatments over a one-week period at the study's three active clinical sites in Australia. This trial, which aims to enroll approximately 9 to 18 patients, is designed to evaluate the safety and feasibility of administering the Hemopurifier at varying dosing intervals in patients with solid tumors who have stable or progressive disease, while receiving treatment that includes Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®).

The Company previously pursued approval of a similar clinical trial in India. We received formal approval from the Indian regulatory agency, the Central Drugs Standard Control Organization (CDSCO), to conduct this trial in India on July 7, 2025. We were working with our India CRO, Qualtran, toward site initiation at Medanta Medicity Hospital. However, after reviewing extended timelines associated with site activation and trial execution, we made the decision to cancel the Indian trial to conserve resources and to concentrate efforts on the Australian oncology trial.

The Hemopurifier is designed to address life-threatening viral infections, particularly those involving highly glycosylated viruses for which there are no approved therapies. It has previously been used under FDA and international regulatory frameworks to treat individuals infected with HIV, hepatitis C, Ebola, and SARS-CoV-2. While our COVID-19 clinical trials in the U.S. and India have been terminated due to low ICU enrollment, these programs provided real-world evidence of Hemopurifier use in critically ill patients. We maintain an open IDE for viral indications, preserving the ability to respond to future outbreaks or emerging pathogens.

In addition to our ongoing clinical trials, we continue to explore potential new applications for the Hemopurifier through internal pre-clinical research. In the first fiscal quarter of 2026, results of our pre-clinical ex-vivo study entitled “Ex Vivo Removal of CD41 positive platelet microparticles from Plasma by a Medical Device containing a Galanthus nivalis agglutinin (GNA) affinity resin” were published in the pre-print vehicle bioRxiv. This manuscript has been submitted to a peer-reviewed publication for review. In the study we evaluated the Hemopurifier’s ability to remove disease-relevant extracellular vesicles (EVs), including those derived from platelets, which are implicated in cancer, autoimmune disease, and neurological disorders. The study demonstrated >98% removal of platelet-derived EVs from healthy human plasma in a simulated clinical session. We are also collaborating with academic researchers to investigate EV characteristics in patients with Long COVID. These exploratory programs are intended to inform potential future clinical indications and expand the utility of the Hemopurifier platform.

Successful outcomes of human trials will also be required by the regulatory agencies of certain foreign countries where we plan to market and sell the Hemopurifier. Some of our patents may expire before FDA approval or approval in a foreign country, if any, is obtained. However, we believe that certain patent applications and/or other patents issued to us more recently will help protect the proprietary nature of our Hemopurifier treatment technology.

In addition to the foregoing, we are monitoring closely the impact of inflation, recent bank failures and the war between Russia and Ukraine and the military conflicts in Israel and the surrounding areas, as well as related political and economic responses and counter-responses by various global factors on our business. Given the level of uncertainty regarding the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess the impact on our timelines and future access to capital. The full extent to which inflation, recent bank failures and the ongoing military conflicts will impact our business, results of operations, financial condition, clinical trials and preclinical research will depend on future developments, as well as the economic impact on national and international markets that are highly uncertain.

We incorporated in Nevada on March 10, 1999. Our executive offices are located at 11555 Sorrento Valley Road, Suite 203, San Diego, California 92121. Our telephone number is (619) 941-0360. Our website address is www.aethlonmedical.com.

Our common stock is listed on the Nasdaq Capital Market under the symbol “AEMD.”

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

During the six months ended September 30, 2025, there were no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2025.

REVERSE STOCK SPLITS

On October 16, 2025, the Company implemented a 1-for-10 reverse stock split of its then outstanding shares of common stock, with trading of the post-split shares beginning October 20, 2025. Accordingly, each 10 shares of outstanding common stock then held by our stockholders were combined into one share of common stock. Any fractional shares resulting from the reverse split were rounded up to the next whole share. Authorized common stock was 6,000,000 shares following the stock split. The reverse stock split was effected in anticipation of, and to address, a Nasdaq notification regarding noncompliance with the minimum bid price requirement for continued listing. The accompanying unaudited condensed consolidated financial statements and accompanying notes have been retroactively revised to reflect such reverse stock split as if it had occurred on April 1, 2024. All shares and per share amounts have been revised accordingly.

On June 9, 2025, we effected a 1-for-8 reverse stock split of our then outstanding shares of common stock. Accordingly, each 8 shares of outstanding common stock then held by our stockholders were combined into one share of common stock. Any fractional shares resulting from the reverse split were rounded up to the next whole share. Authorized common stock remained at 60,000,000 shares following the stock split. The accompanying unaudited condensed consolidated financial statements and accompanying notes have been retroactively revised to reflect such reverse stock split as if it had occurred on April 1, 2024. All shares and per share amounts have been revised accordingly.

Basis of Presentation and Use of Estimates

Our accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 8 of the Securities and Exchange Commission, or SEC, Regulation S-X. Accordingly, they should be read in conjunction with the audited financial statements and notes thereto for the fiscal year ended March 31, 2025, included in our Annual Report on Form 10-K filed with the SEC on June 26, 2025. The accompanying unaudited condensed consolidated financial statements include the accounts of Aethlon Medical, Inc. and its wholly owned subsidiary, Aethlon Medical Australia Pty Ltd. All significant inter-company transactions and balances have been eliminated in consolidation. The accompanying unaudited condensed consolidated financial statements, taken as a whole, contain all adjustments that are of a normal recurring nature necessary to present fairly our operating results, cash flows, and financial position as of and for the period ended September 30, 2025. Estimates were made relating to useful lives of fixed assets, impairment of assets, share-based compensation expense and accruals for clinical trial and research and development expenses. Actual results could differ materially from those estimates. The accompanying condensed consolidated balance sheet at March 31, 2025 has been derived from the audited consolidated balance sheet at March 31, 2025, contained in the above referenced 10-K. The results of operations for the three and six months ended September 30, 2025 are not necessarily indicative of the results to be expected for the full year or any future interim periods.

Reclassifications

Certain prior year balances within the unaudited condensed consolidated financial statements have been reclassified to conform to the current year presentation, including the impact of the reverse stock splits.

LIQUIDITY AND GOING CONCERN

Management expects existing cash as of September 30, 2025 to not be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these condensed consolidated financial statements. As a result, there is substantial doubt about the Company’s ability to continue as a going concern.

We are actively evaluating a range of strategic and financing options to extend our cash runway and support our ongoing operations, including clinical development activities. These options include potential equity offerings and other funding opportunities. However, there can be no assurance that any such financing will be available on acceptable terms, or at all.

Our ability to continue as a going concern is dependent upon securing additional capital and successfully executing our business plans. If we are unable to raise additional capital when needed, we may be forced to significantly curtail or cease operations, including research and development programs and clinical trials.

The accompanying unaudited condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the ordinary course of business.

Restricted Cash

As of September 30, 2025, we maintained a restricted cash balance of $98,448 in an interest-bearing money market deposit account with JPMorgan Chase, which supports our lease obligations. This balance includes a $5,000 buffer above the required security amount.

  1. LOSS PER COMMON SHARE

Basic loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period of computation. Diluted loss per share is computed similar to basic loss per share, except that the denominator is increased to include the number of additional dilutive common shares that would have been outstanding if potential common shares had been issued, if such additional common shares were dilutive. Since we had net losses for all periods presented, basic and diluted loss per share are the same, and additional potential common shares have been excluded, as their effect would be antidilutive.

As of September 30, 2025 and 2024, an aggregate of 737,149 and 169,016 potential common shares, respectively, consisting of shares underlying outstanding stock options, warrants, and restricted stock units were excluded, as their inclusion would be antidilutive.

  1. RESEARCH AND DEVELOPMENT EXPENSES

Our research and development costs are expensed as incurred. We incurred research and development expenses during the three- and six-month periods ended September 30, 2025 and 2024, which are included in various operating expense line items in the accompanying condensed consolidated statements of operations. Our research and development expenses in those periods were as follows:

Schedule of research and development expenses
September 30,September 30,
20252024
Three months ended$294,318$261,486
Six months ended818,686702,115

During the three and six months ended September 30, 2025, we recognized an R&D tax incentive related to our clinical trial activities conducted in Australia. The Australian R&D incentive is a government program that provides refundable tax offsets for eligible research and development expenditures incurred in Australia. The incentive is recorded as a reduction of research and development expense when the related qualifying expenditures are incurred and receipt of the credit is considered probable. We recognized approximately $218,000 related to this incentive during the current quarter, which reduced reported R&D expense for both the three- and six-month periods ended September 30, 2025 (see Note 11).

  1. RECENT ACCOUNTING PRONOUNCEMENTS

In December 2023, the FASB issued Accounting Standards Update 2023-09, Income Taxes (Topic 740*): Improvements to Income Tax Disclosures*, which requires enhanced annual disclosures related to tax rate reconciliation and income taxes paid disaggregated by federal, state and foreign taxes. ASU 2023-09 is effective for the Company for annual periods beginning on or after April 1, 2025. The Company maintains a full valuation allowance against its deferred assets and does not have current income tax expense nor material income taxes paid. While the Company is evaluating the impact of this new standard on its income tax disclosures, it does not expect the adoption of ASU 2023-09 to have material impact on its consolidated financial statements, as the amendments relate to disclosures only.

In November 2024, the FASB issued Accounting Standards Update 2024-03,Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (“ASU 2024-03”), which requires public business entities to provide enhanced annual and interim disclosures that disaggregate specified income statement expense categories. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. In January 2025 the FASB issued Accounting Standards Update 2025-01,Income Statement — Reporting Comprehensive Income — Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date, to clarify effective dates of in ASU 2024-03. The Company is currently evaluating the potential impact of this guidance on its disclosures.

In March 2024, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2024-02,Codification Improvements—Amendments to Remove References to the Concepts Statements (“ASU 2024-02”). ASU 2024-02 eliminates various references to the FASB’s Concepts Statements from the FASB Accounting Standards Codification in order to clarify that the Codification represents the authoritative source of generally accepted accounting principles (GAAP) in the United States. The amendments do not alter existing accounting requirements. The guidance is effective for fiscal years, including interim periods within those fiscal years, beginning after December 15, 2024, and early adoption is permitted. This ASU is not expected to have a material impact on the Company’s consolidated financial statements or disclosures.

  1. EQUITY TRANSACTIONS IN THE SIX MONTHS ENDED SEPTEMBER 30, 2025

October 2025 Reverse Stock Split

On October 16, 2025, the Company implemented a 1-for-10 reverse stock split of its then outstanding shares of common stock, with trading of the post-split shares beginning October 20, 2025 Accordingly, each 10 shares of outstanding common stock then held by our stockholders were combined into one share of common stock. Any fractional shares resulting from the reverse split were rounded up to the next whole share. Authorized common stock was adjusted accordingly to 6,000,000 shares following the stock split. The reverse stock split was effected in anticipation of, and to address, a Nasdaq notification regarding noncompliance with the minimum bid price requirement for continued listing. The accompanying unaudited condensed consolidated financial statements and accompanying notes have been retroactively revised to reflect such reverse stock split as if it had occurred on April 1, 2024. All shares and per share amounts have been revised accordingly.

June 2025 Reverse Stock Split

Effective as of the close of business on June 6, 2025 with an effective trading date of June 9, 2025, we effected a 1-for-8 reverse stock split of our then outstanding shares of common stock. Accordingly, each 8 shares of outstanding common stock then held by our stockholders were combined into one share of common stock. Any fractional shares resulting from the reverse split were rounded up to the next whole share. Authorized common stock remained at 60,000,000 shares following the stock split. The accompanying consolidated financial statements and accompanying notes have been retroactively revised to reflect such reverse stock split as if it had occurred on April 1, 2024. All shares and per share amounts have been revised accordingly.

September 2025 Registered Direct Offering

On September 4, 2025, we entered into a Securities Purchase Agreement with certain investors pursuant to which it agreed to sell (i)4,047,780 shares of common stock, (ii)952,220 pre-funded warrants, and (iii)5,000,000 common warrants to purchase up to 5,000,000 shares of common stock at an exercise price of $0.90 per share. The securities were offered as part of a registered public offering on Form S-1 (File No. 333-289745), which was declared effective by the SEC on September 4, 2025. The combined public offering price for each share (or pre-funded warrant in lieu thereof) and accompanying common warrant was $0.90 per unit.

The offering closed on September 5, 2025, and we received gross proceeds of approximately $4.5 million and net proceeds of approximately $3.7 million, after deducting placement agent fees and other offering expenses. Maxim Group LLC acted as the exclusive placement agent and received a cash fee of 6.25% of gross proceeds, reimbursement of $100,000 of expenses, and warrants to purchase up to 200,000 shares of common stock at an exercise price of $0.90 per share.

We intend to use the net proceeds from the offering for working capital and general corporate purposes.

In connection with the offering, the Company and its officers and directors agreed to customary lock-up provisions restricting certain issuances or sales of securities for up to 90 days following the closing.

Restricted Stock Unit Grants

In April 2025, the Compensation Committee of the Board, or Compensation Committee, approved, pursuant to the terms of our Amended and Restated Non-Employee Director Compensation Policy, or the Director Compensation Policy, the grant of the annual RSUs under the Director Compensation Policy to each of the three non-employee directors of the Company then serving on the Board of Directors of the Company, or Board. The Director Compensation Policy provides for a grant of stock options or $50,000 worth of RSUs at the beginning of each fiscal year for current non-employee directors then serving on the Board, and for a grant of stock options or $75,000 worth of RSUs for a newly elected non-employee director, with each RSU priced at the average for the closing prices for the five days preceding and including the date of grant, or $20.80 per share for the April 2025 RSU grants. As a result, in April 2025 the four eligible directors were each granted an RSU in the amount of 1,786 shares under the 2020 Plan. The RSUs are subject to vesting in four equal installments, with 25% of the restricted stock units vesting on each of June 30, 2025, September 30, 2025, December 31, 2025, and March 31, 2026, subject in each case to the director’s Continuous Service (as defined in the 2020 Plan), through such dates. Vesting will terminate upon the director’s termination of Continuous Service prior to any vesting date.

During the three- and six-months ended September 30, 2025,1,340 and 2,680 shares were issued upon settlement of 1,787 and 3,573 RSUs, respectively.

  1. RELATED PARTY TRANSACTIONS

During the three-months ended September 30, 2025, we accrued $68,250 for board fees and paid fees of $68,250 owed to our non-employee directors for services in the current and prior quarter respectively. In the six-months ended September 2025 and September 2024 we accrued $136,500 for board fees and paid out an aggregate $136,500.

The accrued balance for separation expenses at September 30, 2025, relates to agreement with a former executive officer from a prior period; no new separation accruals were recorded during the quarter.

Amounts due to related parties were comprised of the following items:

Schedule of amounts due to related parties
September 30, 2025March 31, 2025
Accrued Board fees$68,250$68,250
Accrued vacation to all employees162,753165,029
Accrued separation expenses17,451346,286
Total due to related parties$248,454$579,565
  1. OTHER CURRENT LIABILITIES

Other current liabilities were comprised of the following items:

Schedule of other current liabilities
September 30,March 31,
20252025
D&O insurance premium financing$45,639$178,206
Accrued professional fees166,392247,631
Accrued resale registration46,32746,327
Employee related FSA accruals2,737–
Total other current liabilities$261,095$472,164
  1. STOCK COMPENSATION

All of the stock-based compensation expense recorded during the three and six months ended September 30, 2025 and 2024, aggregating $72,442 and $113,493 for the three-month periods and $144,884 and $252,821 for the six-month periods, respectively, is included in payroll and related expense in the accompanying condensed consolidated statements of operations. Stock-based compensation expense recorded during the three and six months ended September 30, 2025 and 2024 represented an impact on basic and diluted loss per common share of $(0.18) and $(0.65) for the three-month periods and $(0.47) and $(1.89) for the six-month periods, respectively.

Stock Option Activity

We did not issue any stock options during the six-months ended September 30, 2025 and 2024.

Stock options outstanding that have vested as of September 30, 2025 and stock options that are expected to vest subsequent to September 30, 2025 are as follows:

Schedule of stock options outstanding
Number of SharesWeighted Average Exercise PriceWeighted Average Remaining Contractual Term in Years
Vested624$1,314.865.57
Expected to vest35$1,128.006.36
Total659

A summary of stock option activity during the three months ended September 30, 2025 is presented below:

Schedule of stock option activity
AmountRange of Exercise PriceWeighted Average Exercise Price
Outstanding at beginning of year659$1,024.00 – 2,016.00$1,305
Granted–$–$–
Cancelled/Expired–$–$–
Outstanding September 30, 2025659$1,024.00 – 2,016.00$1,305
Exercisable, September 30, 2025624$1,024.00 – 2,016.00$1,315

There wereno stock option grants during the three months ended September 30, 2025 and 2024. There wereno RSUs granted during the three months ended September 30, 2025. There wereno stock option exercises during the three months ended September 30, 2025 and 2024. On September 30, 2025, our outstanding stock options hadno intrinsic value, since the closing share price on that date of $7.49 per share was below the exercise price of our outstanding stock options.

The table below summarizes nonvested stock options as of September 30, 2025 and changes during the six months ended September 30, 2025.

Schedule of non vested stock options
SharesWeighted Average Grant Date Fair Value
Nonvested stock options at April 1, 202576$1.37
Vested(41)$1.37
Forfeited–
Nonvested stock options at September 30, 202535

The detail of the options outstanding and exercisable as of September 30, 2025 is as follows:

Schedule of options outstanding and exercisable
Options Outstanding · Options Exercisable
Exercise PricesNumber OutstandingWeighted Average Remaining Life (Years)Weighted Average Exercise PriceNumber OutstandingWeighted Average Exercise Price
$1,024.00 – 1,128.005075.72 years$1,091.90472$1,089.00
$2,016.001525.26 years$2,016.00152$2,016.00
659624

The table below summarizes restricted stock units as of September 30, 2025 and changes during the six months ended September 30, 2025.

Schedule of RSUs
Shares
Nonvested RSUs at April 1, 2025–
Granted7,144
Vested(3,572)
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units(893)
Nonvested RSUs at September 30, 20252,679

Our total stock-based compensation for the six months ended September 30, 2025 and 2024 included the following:

Schedule of stock-based compensation
Six Months Ended
September 30, 2025September 30, 2024
Vesting of restricted stock units$100,000$118,750
Vesting of stock options44,884134,071
Total Stock-Based Compensation$144,884$252,821

We review share-based compensation on a quarterly basis for changes to the estimate of expected award forfeitures based on actual forfeiture experience. The cumulative effect of adjusting the forfeiture rate for all expense amortization is recognized in the period the forfeiture estimate is changed. The effect of forfeiture adjustments for the three months ended September 30, 2025 was insignificant.

At September 30, 2025, there was approximately $133,363 of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average period of 0.46 years.

  1. WARRANTS

We issued 520,000 warrants in the three-months ended September 30, 2025 in connection with our September 5, 2025 offering. We issued 206,550 warrants in connection with the May 17, 2024 public offering during three-months ended June 2024.

A summary of warrant activity during the six months ended September 30, 2025 is presented below:

Schedule of warrant activity
AmountRange of Exercise PriceWeighted Average Exercise Price
Warrants outstanding at March 31, 2025235,711$29.89 – 46.40$35.54
Granted520,0009.009.00
Exercised–$–$–
Cancelled/Expired(22,793)$46.40$46.40
Warrants outstanding at September 30, 2025732,918$9.00 – 46.40$16.37
Warrants exercisable at September 30, 2025732,918$9.00 – 46.40$16.37
  1. COMMITMENTS AND CONTINGENCIES

LEASE COMMITMENTS

Office, Lab and Manufacturing Space Leases

In December 2020, we entered into an agreement to lease approximately 2,823 square feet of office space and 1,807 square feet of laboratory space located at 11555 Sorrento Valley Road, Suite 203, San Diego, California 92121 and 11575 Sorrento Valley Road, Suite 200, San Diego, California 92121, respectively. The agreement carries a term of 63 months and we took possession of the office space effective October 1, 2021. We took possession of the laboratory space effective January 1, 2022. In October 2021, we entered into another lease for approximately 2,655 square feet of space to house our manufacturing operations located at 11588 Sorrento Valley Road, San Diego, California 92121. The term is for 55 months and we took possession of the manufacturing space in August 2022. The current monthly base rent under the office and laboratory component of the lease is $14,591. The current monthly base rent under the manufacturing component of the lease is $13,195.35. Cash paid in the three months ended September 30, 2025 for amounts included in the measurement of operating lease liabilities in operating cash flows was $82,614.

The office, lab and manufacturing leases are coterminous with a remaining term of 18 months. The weighted average discount rate is 4.25%.

As of our September 30, 2025 balance sheet, we have an operating lease right-of-use asset of $456,496 and operating lease liability of $496,772.

In connection with the lease agreements for our office, lab, and manufacturing space, we were required to provide financial assurance to the landlord in lieu of a traditional security deposit. To satisfy this requirement, we initially arranged for our former bank to issue two standby letters of credit (L/Cs) totaling $87,506 — $46,726 in fiscal year 2021 for the office and lab space, and $40,780 in fiscal year 2022 for the manufacturing space. Equivalent funds were transferred into restricted certificates of deposit to secure the bank’s risk.

Following the transition of our banking relationship to JPMorgan Chase, the L/Cs were replaced with an interest-bearing money market deposit account. As of September 30, 2025, we maintained a restricted cash balance of $98,448 in this account, which includes a $5,000 buffer above the required security amount. This balance continues to support our lease obligations and is classified as restricted cash on our balance sheet.

Overall, our rent expense, which is included in general and administrative expenses, approximated $140,229 for the three months ended September 30, 2025. This amount includes a nonrecurring charge of $33,305 related to a forfeiture of a deposit of a previously rented mobile clean room. Excluding this one-time item, recurring rent expense was approximately $107,000. Rent expense for the three-month period ending September 30, 2024 was approximately $108,000.

For the six months ended September 30, 2025, rent expense totaled approximately $249,418, which includes the same $33,305 nonrecurring charge. Excluding this item, recurring rent expense for the six-month period was approximately $216,113, compared to approximately $210,000 for the six months ended September 30, 2024.

In January 2025, the Company entered into a short-term premium financing agreement with FIRST Insurance Funding, a division of Lake Forest Bank & Trust Company, N.A., to finance a portion of its Directors & Officers (D&O) and other insurance premiums. The total amount financed under the agreement was approximately $220,984 with an associated finance charge of approximately $9,995 resulting in a total repayment obligation of approximately $230,979. The annual percentage rate is 9.75%, and the loan is payable in 10 monthly installments of approximately $23,098 beginning February 28, 2025.

As collateral for the financing, the Company granted the lender a first priority security interest in the financed insurance policies, including all unearned premiums, dividends, credits, and certain loss payments. In the event of default, cancellation, or early termination of the policies, the lender has the right to collect any unearned premiums and apply them against the remaining loan balance.

This arrangement is classified as a short-term liability within other liabilities on the balance sheet (See Note 7) and is recorded net of any prepaid portions of the insurance policies.

LEGAL MATTERS

We may be involved from time to time in various claims, lawsuits, and/or disputes with third parties or breach of contract actions incidental to the normal course of our business operations. We are currently not involved in any litigation or any pending legal proceedings.

  1. RECEIVABLE FROM AUSTRALIAN RESEARCH AND DEVELOPMENT TAX INCENTIVE (R&DTI)

During the three months ended September 30, 2025, we submitted a tax return to the Australian tax authorities covering our research and development operations in Australia related to our clinical trial in that country under their R&DTI. In October 2025, we received a payment under the R&DTI of Australian $330,179, which was the equivalent to US $218,314. We present all research and development amounts within general and administrative expenses; therefore, the US $218,314 was recorded as a receivable on our September 30, 2025 balance sheet and as a reduction to general and administrative expenses (see Note 3).

  1. SEGMENT REPORTING

The Company operates as a single operating and reportable segment, which reflects how the Chief Operating Decision Maker (CODM), the Company’s Chief Executive Officer, manages the business and allocates resources. The Company is a development-stage medical technology company focused on advancing a clinical-stage therapeutic device, with key operational decisions driven by cash availability, development milestones, and the expected return on investment associated with future manufacturing and commercialization efforts.

Although the Company does not generate commercial revenue, the CODM regularly reviews certain expense categories and cash flow metrics to monitor progress and inform resource allocation. The primary internal performance measure used by the CODM is cash used in operating activities, rather than traditional profit or loss metrics.

In accordance with ASU 2023-07, which the Company adopted for the fiscal year ended March 31, 2025. The following table summarizes key financial information reviewed by the CODM to evaluate operating performance and cash utilization. All amounts presented exclude the Australian R&D tax incentive credit of approximately $218,000.

Schedule of significant expense categories
CategoryThree Months EndedSix Months Ended
September 30, 2025September 30, 2024September 30, 2025September 30, 2024
Research and development¹$512,000$262,000$1,036,000$702,000
General and administrative²$739,000$958,000$1,475,000$1,709,000
Cash used in operating activities³$1,657,000$2,214,000$3,372,000$3,962,000

Amounts in this table are rounded to the nearest thousand.

¹Research and development expenses primarily include costs related to laboratory operations, clinical trial execution, investigational device testing, design iterations, and personnel expenses associated with research activities. These costs are recorded within payroll, professional fees, and general and administrative (“G&A”) expense on the face of the statements of operations, as the Company does not maintain a separate R&D line item.
²General and administrative expenses encompass overhead, administrative costs associated with clinical trial operations, and certain manufacturing-related costs. R&D costs are included within these categories for financial reporting purposes and are not separately reclassified.
³Cash used in operating activities is the key internal performance metric tracked by the CODM to evaluate development progress, cash needs, and investment strategy in the absence of commercial revenue.

The Company does not allocate assets to operating segments, nor does the CODM evaluate performance using a segment profit or loss measure. There were no changes in the internal reports provided to or reviewed by the CODM during the periods presented.

Entity-Wide Information

·The Company did not recognize revenue during the six months ended September 30, 2025.
·All long-lived assets are located in the United States.
·A significant portion of clinical trial activity is conducted through the Company’s wholly owned subsidiary in Australia.
  1. SUBSEQUENT EVENTS

On October 16, 2025, the Company implemented a 1-for-10 reverse stock split of its then outstanding shares of common stock, with trading of the post-split shares beginning October 20, 2025. Under the reverse stock split, every 10 shares of common stock held by stockholders were combined into one share, and any fractional shares were rounded up to the next whole share. Following the split, the Company’s authorized common stock was adjusted accordingly to 6,000,000 shares. The reverse stock split was effected proactively in anticipation of, and to address, Nasdaq’s minimum bid price requirement for continued listing. The accompanying unaudited condensed consolidated financial statements and notes have been retroactively revised to reflect the reverse stock split as if it had occurred on April 1, 2024, with all shares and per-share amounts revised accordingly.

On October 16, 2025, the Company received a notice from Nasdaq stating that its common stock had been below $1.00 per share for 30 consecutive business days, resulting in noncompliance with the minimum bid price requirement under Listing Rule 5550(a)(2) and pursuant to Listing Rule 5810(c)(3)(A)(iv), the Company is not eligible for any compliance period specified in Rule 5810(c)(3)(A) due to the fact that the Company has effected a reverse stock split over the prior one-year period or has effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one. On October 31, 2025, the Company regained compliance with the minimum bid price requirement, and as such on November 5, 2025, Nasdaq notified the Company that the matter is now closed. The Company remains in compliance with all other Nasdaq continued listing requirements.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.