What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-11 compared with 2025-11-12 · 108 added, 115 removed, 131 unchanged (63% of the section changed)

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You should review the disclosure under the heading “Risk Factors” in this Quarterly Report on Form 10-Q for a discussion of important factors that could cause our actual results to differ materially from those anticipated in these forward-looking statements.

We are a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections.

Our approach is to develop antibiotic candidates with a Gram-positive selective spectrum (“GPSS®”) that block the active site of the Gram positive specific bacterial enzyme deoxyribonucleic acid (“DNA”) polymerase IIIC (“pol IIIC”), inhibiting DNA replication and leading to Gram-positive bacterial cell death.

Our research and development (“R&D”) pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile , methicillin-resistant Staphylococcus aureus (“MRSA”), vancomycin resistant Enterococcus (“VRE”) and drug-resistant Streptococcus pneumoniae (“DRSP”).

These bacterial targets are listed as priority pathogens by the World Health Organization (“WHO”), the United States (“U.S.”) Centers for Disease Control and Prevention (“CDC”) and the U.S.

Acurx Pharmaceuticals, Inc., (the “Company”), a Delaware corporation, formerly Acurx Pharmaceuticals, LLC (the “Company”) is a clinical stage biopharmaceutical company developing a new class of antibiotics for infections caused by bacteria listed as priority pathogens by the World Health Organization (“WHO”), the U.S.

Centers for Disease Control and Prevention (“CDC”) and the U.S.

Food and Drug Administration (“FDA”).

Priority pathogens are those which require new antibiotics to address the worldwide crisis of antimicrobial resistance (“AMR”) as identified by the WHO, CDC and FDA.

Our Market Opportunity

The CDC estimates that, in the U.S., antibiotic-resistant pathogens infect one individual every 11 seconds and result in one death every 15 minutes.

According to the WHO Fact Sheet (November 2023), AMR is one of the top global public health and development threats.

According to the WHO Fact Sheet (November 2023) Antimicrobial Resistance (AMR) is one of the top global public health and development threats.

It is estimated that bacterial AMR was directly responsible for 1.27 million global deaths in 2019 and contributed to 4.95 million deaths.

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There is an inadequate research and development pipeline in the face of rising levels of resistance, and urgent need for additional measures to ensure equitable access to new and existing vaccines, diagnostics and medicines.

We believe we are developing the first DNA pol IIIC inhibitor to enter Phase 3 clinical trials and our Phase 2 clinical trial has provided positive clinical trial results for our lead pol IIIC antibiotic candidate.

Our approach is to develop a new class of antibiotic candidates that block the DNA polymerase IIIC (“pol IIIC”).

We believe we are developing the first pol IIIC inhibitor to enter clinical trials and have clinically validated the bacterial target by demonstrating the efficacy of our lead antibiotic candidate in a Phase 2a clinical trial.

pol IIIC is the primary catalyst for DNA replication of several Gram-positive bacterial cells.

Our research and development pipeline includes clinical stage and early-stage antibiotic candidates that target Gram-positive bacteria for oral and/or parenteral treatment of infections caused by Clostridioides difficile (“C.

difficile”), Enterococcus (including VRE), Staphylococcus (including MRSA), and Streptococcus (including antibiotic resistant strains).

difficile”), Enterococcus (including vancomycin-resistant strains (“VRE”)), Staphylococcus (including methicillin-resistant strains), Streptococcus (including antibiotic resistant strains) and B.

anthracis (anthrax).

Pol IIIC is required for the replication of DNA in certain Gram-positive bacterial species.

By blocking this enzyme, our antibiotic candidates are believed to be bactericidal and inhibit proliferation of several common Gram-positive bacterial pathogens, including both sensitive and resistant C.

difficile , MRSA, vancomycin-resistant Enterococcus, penicillin-resistant Streptococcus pneumonia (“PRSP”) and other resistant bacteria.

We expect to partner with a fully-integrated pharmaceutical company for late-stage clinical trials and commercialization or conduct Phase 3 clinical trials prior to such partnership and continue to review partnership opportunities on an ongoing basis up to FDA approval.

difficile, methicillin-resistant Staphylococcus aureus (“MRSA”), vancomycin-resistant Enterococcus, penicillin-resistant Streptococcus pneumonia (“PRSP”), B.

anthracis (anthrax) and other resistant bacteria.

We intend to “de-risk” this new class of antibiotics through our drug development activities and potentially partner with a fully-integrated pharmaceutical company for late-stage clinical trials and commercialization.

Our lead antibiotic candidate, ibezapolstat (formerly named ACX 362E), has a novel mechanism of action that targets the pol IIIC enzyme, a previously unexploited scientific target.

A Phase 2 clinical trial, comprised of a Phase 2a segment and a Phase 2b segment, provided data that demonstrates positive clinical trial results for our lead antibiotic candidate and demonstrates pol IIIC as an appropriate bacterial target.

Our Lead Product Candidate

Currently available antibiotics used to treat C .

difficile infections (“CDI”) utilize other mechanisms of action.

We believe ibezapolstat is the first antibiotic candidate in late-stage clinical trials to work by blocking the DNA pol IIIC enzyme in C.

Phase 2a clinical efficacy of our lead antibiotic validate the pol IIIC bacterial target.

On December 3, 2021, we commenced enrollment in a Phase 2b 64-patient, randomized (1-to-1), non-inferiority, double-blind, trial of oral ibezapolstat compared to oral vancomycin, a standard of care to treat C.

difficile infections (“CDI”).

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) study at 28 U.S.

clinical trial sites which together comprise the Phase 2 clinical trial.

This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline.

In the Phase 2a trial segment, 10 patients with diarrhea caused by C.

difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days.

All patients were followed for recurrence for 28± two

Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment, 10 of 10).

In the Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every six hours, in each case, for 10 days and followed for 28 ± two days following the end of treatment for recurrence of CDI.

The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind.

In this Phase 2b trial segment, 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population experienced Clinical Cure (CC) and all 15 of 15 (100%) remained free of CDI recurrence through one month after end of treatment (“EOT”).

When Phase 2b results are combined with Phase 2a results, the Clinical Cure rate in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat.

Notably, in the combined Phase 2 trial, 100% (25 of 25) of ibezapolstat-treated patients who had Clinical Cure at EOT remained cured through one month after EOT, as compared to 86% (12 of 14) for the vancomycin patient group.

Ibezapolstat was well-tolerated, with no serious adverse events assessed by the blinded investigator to be drug- related.

The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96%, Sustained Clinical Cure Rate of 100% and the historical vancomycin Clinical Cure Rate range of 70% to 92% and a Sustained Clinical Cure historical range of 42% to 74%, we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials, in accordance with the applicable FDA Guidance for Industry (October 2022), with favorable differentiation in both Clinical Cure and Sustained Clinical Cure.

In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (“PK”) and microbiome changes and tested for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy.

Phase 2a data demonstrated complete eradication of colonic C.

difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy.

Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C.

A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin.

The Company also reported positive extended clinical cure (“ECC”) data for ibezapolstat (“IBZ”), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI.

This exploratory endpoint showed that 5 of 5 IBZ patients followed for up to three months following Clinical Cure experienced no recurrence of infection.

Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

Currently available antibiotics used to treat CDI infections utilize other mechanisms of action.

We believe ibezapolstat is the first antibiotic candidate to work by blocking the DNA pol IIIC enzyme in C.

This enzyme is necessary for replication of the DNA of certain Gram-positive bacteria, like C.

Our Other Candidates

We also have an early-stage pipeline of antibiotic product candidates with the same previously unexploited mechanism of action which has established proof of concept in animal studies.

This pipeline includes ACX-375C, a potential oral and parenteral treatment targeting Gram-positive bacteria, including MRSA, VRE and PRSP.

We continue to evaluate strategic transactions for the Company, including a partner for the further development and potential commercialization of our lead antibiotic candidate, ibezapolstat, as well as a potential sale, merger, third-party licensing arrangement or other strategic transaction.

At this time, we have no commitments from potential partners or others to provide the Company with capital.

This pipeline includes ACX 375C, a potential oral and parenteral treatment targeting Gram-positive bacteria, including MRSA, VRE and PRSP and B.

anthracis (anthrax).

Pioneering data demonstrates that ibezapolstat has unique selective antibacterial activity in the gut which spares beneficial bile acid-metabolizing bacteria.

The favorable gut bile acid profile contributes to ibezapolstat's anti-recurrence effect in patients with CDI.

New data presented at IDWeek in October 2025 demonstrated that representative novel compounds from our DNA pol IIIC inhibitor preclinical pipeline provide initial evidence that microbiome selectivity, when compared to the comparator antibiotic, linezolid, may be a class effect.

As of March 31, 2026, we had cash of approximately $9.3 million.

Recent Developments

April 2026 Registered Direct Offering and Concurrent Private Placement

On April 15, 2026, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with the investors named therein (the “Investors”), pursuant to which we agreed to issue and sell, in a registered direct offering by us directly to the Investors (the “April 2026 Registered Offering”) (i) 816,068 shares of common stock, par value $0.001 per share, of the Company (the “Common Stock”) at a purchase price of $3.03 per share and (ii) pre-funded common stock purchase warrants to purchase up to 9,017 shares of Common Stock at a purchase price of $3.029 per share for aggregate gross proceeds of approximately $2.5 million, before deducting the placement agent fees and related offering expenses.

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

In a concurrent private placement to the April 2026 Registered Offering, the Company issued unregistered short-term warrants to purchase up to 1,650,170 shares of Common stock.

The short-term warrants have an exercise price of $2.78 per share, were immediately exercisable upon issuance and will expire twenty-four months following the effective date of the registration statement registering the resale of the share of common stock underlying the short-term warrants.

Pursuant to the terms of the Purchase Agreement, the Company agreed to use commercially reasonable efforts to cause a registration statement on Form S-1 providing for the resale by holders of shares of its Common Stock issuable upon the exercise of the short-term warrants, to become effective within 60 calendar days following the date of the Purchase Agreement (or within 90 calendar days following the date of the Purchase Agreement in case of a “full review” by the Commission) and to keep such registration statement effective at all times until the Investors do not own any short-term warrants or shares of Common Stock issuable upon exercise thereof.

Ibezapolstat Program Clinical Development

On March 9, 2026, the Company announced a new clinical development initiative to expand the ibezapolstat program into recurrent C.

difficile infection (rCDI).

The initiative includes an open label pilot trial in multiply recurrent CDI that will enroll up to 20 patients who have experienced at least two recurrences within the past 12 months.

Trial start up activities are scheduled to begin later this month, and first patient enrollment is expected in the fourth quarter of this year.

The Company intends to use data from this 20 patient study to inform the design of a planned active controlled Phase 3 registration trial in rCDI.

Following a successful pivotal Phase 3 study, the Company plans to seek the United States Food and Drug Administration’s approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) for treatment and prevention of rCDI.

Amendment to our Certificate of Incorporation

At our special meeting of stockholders, held on September 16, 2025, our stockholders approved an amendment (the “Amendment”) to our Certificate of Incorporation, as amended, to increase the total number of authorized shares of our common stock from 200,000,000 to 250,000,000.

On September 22, 2025, we filed the Amendment with the Secretary of State of the State of Delaware with immediate effect.

Reverse Stock Split

On August 4, 2025, we effected a 1-for-20 reverse stock split of our issued and outstanding shares of common stock, and as a result of the reverse-stock-split, on August 26, 2025, we regained compliance with the minimum bid price requirement of $1.00 per share under Nasdaq Listing Rule 5550(a)(2).

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We are now in full compliance with all Nasdaq continued listing requirements and our common stock will remain listed and traded on the Nasdaq Stock Market.

On September 22, 2025, we filed the Amendment with the Secretary of State of the State of Delaware with immediate effect.

Equity Line of Credit Purchase Agreement

On May 8, 2025, we entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $12.0 million in shares of our common stock.

Concurrently with the execution of the Purchase Agreement on May 8, 2025, we also entered into a registration rights agreement (the “Registration Rights Agreement”) with Lincoln Park, relating to the registration under the Securities Act of 1933, as amended (the “Securities Act”), of the offer and sale of the securities that have been and may be issued and sold by us to Lincoln Park, from time to time in our sole discretion, from and after the date of this report, under the Purchase Agreement and to take such other specified actions to maintain such registration under the Securities Act.

Under the terms and subject to the conditions of the Purchase Agreement, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $12.0 million in shares of our common stock.

Such sales of our common stock, if any, will be subject to certain limitations, and may occur from time to time, at our sole discretion, over the 24-month period commencing on May 29, 2025, which was the date the conditions set forth in the Purchase Agreement were satisfied (the “Commencement Date”).

Sales of shares of our common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of our common stock and our

determination as to the appropriate sources of funding for our operations.

We expect that any proceeds we receive from such sales will be used for working capital and general corporate purposes.

In connection with entering into the Purchase Agreement, on May 8, 2025, we issued 44,963 shares of our common stock to Lincoln Park in consideration for its commitment to purchase shares under the Purchase Agreement.

As of the period ended September 30, 2025, we sold 393,532 shares of our common stock under the Purchase Agreement at a weighted-average price of $6.18 per share, raising $2.4 million of gross proceeds and net proceeds of $2.3 million after deducting related fees and expenses.

As of November 11, 2025, total sales under the Purchase agreement is approximately $3.0 million out of $12 million.

Warrant Inducement Agreement

On June 17, 2025, we entered into a warrant inducement agreement (the “Letter Agreement”) with a certain holder (the “Holder”) of existing (i) Series A warrants to purchase 61,538 shares of common stock, (ii) Series B warrants to purchase 27,400 shares of common stock, (iii) Series C warrants to purchase 66,667 shares of common stock, and (iv) Series D warrants to purchase 66,667 shares of common stock (together, the “Existing Warrants”).

Pursuant to the Letter Agreement, the Holder exercised for cash its Existing Warrants to purchase an aggregate of 222,272 shares of common stock, at a reduced exercised price of $12.00 per share, in consideration for our agreement to issue (i) Series G-1 warrants (the “Series G-1 Warrants”) to purchase up to an aggregate of 311,180 shares of common stock (the “Series G-1 Warrant Shares”) and (ii) Series G-2 warrants (the “Series G-2 Warrants” and, together with the Series G-1 Warrants, the “Series G Warrants”) to purchase up to an aggregate of 133,363 shares of common stock, each at an exercise price of $8.50 per share.

Pursuant to the engagement letter entered into with H.C.

Wainwright & Co., LLC (“Wainwright”) in connection with prior financings by the Company and as previously disclosed in the Company’s prior filings with the U.S.

Securities and Exchange Commission (the “SEC”), the Company paid a fee to Wainwright equal to 7.0% of the gross proceeds from the transactions contemplated by the Letter Agreement and issued to Wainwright and its designees warrants (“Wainwright Warrants”) to purchase up to an aggregate of 13,336 shares of common stock, which have the same terms as the Series G Warrants, except that they have an exercise price of $15.00 per share.

The Company received net proceeds of approximately $2.5 million from the exercise of the Existing Warrants by the Holder, after deducting offering fees and other expenses payable by the Company in connection with the transaction.

The Company expects to use the net proceeds of these transactions for general corporate and working capital purposes.

The closing of the transactions contemplated by the Letter Agreement occurred on June 20, 2025 (the “Closing Date”).

Nasdaq Minimum Stockholders’ Equity Requirement

On March 25, 2025, we received a letter from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that we are not in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market (the “Notice”) based on the information provided in our Annual Report on Form 10-K for the year ended December 31, 2024.

Nasdaq Listing Rule 5550(b)(1) requires that companies listed on The Nasdaq Capital Market with a market value of listed securities of less than $35,000,000 and annual net income of less than $500,000 maintain stockholders’ equity of at least $2,500,000 (the "Stockholders’ Equity Requirement”).

In accordance with Nasdaq rules, we were provided 45 calendar days to submit a plan to regain compliance with the Stockholders’ Equity Requirement (the "Compliance Plan”).

We submitted the Compliance Plan on May 9, 2025.

If the Compliance Plan is determined to be acceptable to the Staff, the Staff would have the discretion to grant the Company an extension of 180 calendar days from the date of the Notice to regain compliance with the Stockholders’ Equity Requirement.

There can be no assurance that the Compliance Plan will be accepted or that, if it is, we will be able to regain compliance.

The Notice has no immediate effect on our continued listing on The Nasdaq Capital Market, subject to our compliance with other continued listing requirements.

If the Staff does not accept the Compliance Plan, the Staff will provide written notification to us that the Compliance Plan has been rejected and that our common stock is subject to delisting.

At that time, we may appeal the Staff’s determination to a Nasdaq Hearing Panel.

On August 26, 2025, we received a letter from Nasdaq notifying us that we regained compliance with Nasdaq Listing Rule 5550(b)(1).

Nasdaq Minimum Bid Price Requirement

On February 24, 2025, we received a letter from The Nasdaq Stock Market notifying us that for the preceding 31 consecutive business days, our common stock did not maintain a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).

The notice has no immediate effect on the listing or trading of our common stock, and the common stock will continue to trade on The Nasdaq Capital Market under the symbol “ACXP” at this time.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have a grace period of 180 calendar days, or until August 25, 2025, to regain compliance with Nasdaq Listing Rule 5550(a)(2).

Compliance can be achieved automatically and without further action if the closing bid price of our common stock is at or above $1.00 for a minimum of 10 consecutive business days at any time during the 180-day compliance period, in which case Nasdaq will notify us of our compliance and the matter will be closed.

If, however, we do not achieve compliance with the Minimum Bid Price Requirement by August 25, 2025, we may be eligible for additional time to comply.

In order to be eligible for such additional time, we will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and must notify Nasdaq in writing of our intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary.

However, if it appears to Nasdaq that we will not be able to cure the deficiency, or if we are otherwise not eligible, Nasdaq will provide notice that our common stock will be subject to delisting.

We would then be entitled to appeal that determination to a Nasdaq Hearing Panel.

We intend to actively monitor the bid price of our common stock and will consider available options to regain compliance with the Minimum Bid Price Requirement.

However, there can be no assurance that we will be able to regain compliance with the Minimum Bid Price Requirement or that Nasdaq will grant us a further extension of time to regain compliance, if applicable.

On August 26, 2025, we received a letter from the Nasdaq notifying us that we regained compliance with Nasdaq Listing Rule 5550(a)(2).

The Lincoln Park Transaction

On May 8, 2025, we entered into a purchase agreement (the “Lincoln Park Purchase Agreement”) with Lincoln Park Capital Fund (“Lincoln Park”), pursuant to which Lincoln Park agreed to purchase from us up to an aggregate of $12.0 million of our common stock (subject to certain limitations) from time to time over the term of the Lincoln Park Purchase Agreement (of which an aggregate of $7.3 million of shares of common stock have already been issued and sold to Lincoln Park) (the “ELOC”).

Pursuant to the Lincoln Park

Purchase Agreement, we issued 44,963 shares of common stock to Lincoln Park as a fee for making its irrevocable commitment to purchase our common stock under the Lincoln Park Purchase Agreement (the “Commitment Shares”).

Also on May 8, 2025, we entered into a registration rights agreement with Lincoln Park (the “Registration Rights Agreement”), pursuant to which we filed with the SEC a registration statement (the “First Registration Statement”) on Form S-1 (Registration No.

333-287478) to register up to 544,963 shares of common stock that have subsequently been issued and sold by us to Lincoln Park, consisting of (i) 500,000 shares of common stock that we issued and sold to Lincoln Park as Purchase Shares, commencing on the Commencement Date (as defined below) for aggregate gross proceeds of $3.0 million, and (ii) 44,963 Commitment Shares.

Under the applicable rules of The Nasdaq Stock Market, on July 17, 2025, we obtained stockholder approval to issue to Lincoln Park, pursuant to the Lincoln Park Purchase Agreement, shares of our common stock, including the Commitment Shares, which exceed 220,315 shares, which was equal to 19.99% of the shares of our common stock outstanding immediately prior to the execution of the Lincoln Park Purchase Agreement.

On October 20, 2025, we filed with the SEC a registration statement (the “Second Registration Statement) on Form S-1 (Registration No.

333-290968) to register up to 585,000 shares of common stock.

On February 2, 2026, we filed with the SEC a registration statement (the “Third Registration Statement and, together with the First Registration Statement and the Second Registration Statement, the “Prior Registration Statements”) on Form S-1 (Registration No.

333-293136) to register up to 750,000 shares of common stock.

To date, we have issued and sold 1,835,000 shares of common stock pursuant to the Prior Registration Statements for aggregate gross proceeds of $7.3 million.

Effects of Coronavirus (COVID-19) on Our Business

Public health crises such as pandemics or similar outbreaks could adversely impact our business.

Notably, the COVID-19 pandemic continues to evolve.

The extent to which COVID-19 impacts our operations or those of our collaborators, vendors, contractors, suppliers, clinical trial sites and other material business relations and governmental agencies will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the ultimate duration of the outbreak, new information that will emerge concerning the severity of the virus and the actions to contain it or treat its impact, among others.

While the potential economic impact brought by, and the ultimate duration of, the COVID-19 pandemic, have been, and continue to be, difficult to assess or predict, the spread of COVID-19 has caused a broad impact globally.

The extent to which the COVID-19 pandemic may impact our business continues to be highly uncertain and cannot be predicted with confidence.

In March 2020, the World Health Organization declared the outbreak of COVID 19, a novel strain of coronavirus, a global pandemic.

This outbreak caused major disruptions to businesses and markets worldwide as the virus continued to spread.

The Company’s clinical trial operations were directly and indirectly adversely impacted.

While the acute global emergency phase has passed, the risk of “COVID-19-like” events causing material business interruption remains both credible and ongoing.

While the severity of any future event is uncertain, the probability of a recurrence is meaningful, and the potential for business interruption remains significant.

Actual or potential pandemics, epidemics, or outbreaks of infectious diseases or other emerging pathogens, may adversely affect our business, financial condition, and results of operations.

The extent of these disruptions may include, but are not limited to, interruptions in clinical trial initiation, enrollment, and continuity;

delays in regulatory review and approvals;

reduced access to healthcare providers and patients;

and constraints on manufacturing, supply chain logistics, and distribution channels.

Components of our Results of Operations

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Results of Operations

Three Months Ended September 30, 2025 Compared to the Three Months Ended September 30, 2024

The following table presents a summary of the changes in our results of operations for the three months ended September 30, 2025 compared with the three months ended September 30, 2024:

Three Months Ended March 31, 2026 Compared to the Three Months Ended March 31, 2025

The following table presents a summary of the changes in our results of operations for the three months ended March 31, 2026 compared with the three months ended March 31, 2025:

Three Months Ended

September 30,

(in thousands)

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Research and Development Expenses

Research and development expenses were $0.4 million for the three months ended September 30, 2025 and $1.2 million for the three months ended September 30, 2024, a decrease of $0.8 million due to $0.1 million decrease in manufacturing related costs and $0.7 million decrease in consulting fees as the prior year had higher expenses related to Phase 2b and Phase 3 preparation costs.

General and Administrative Expenses

General and administrative expenses were $1.6 million for the three months ended September 30, 2025 and $1.6 million for the three months ended September 30, 2024.

The expenses remained consistent as $0.2 million decrease in compensation related costs were offset by $0.1 million increase in legal fees.

Net loss was $2.0 million for the three months ended September 30, 2025, and $2.8 million for the three months ended September 30, 2024, a decrease of $0.8 million, due to the reasons stated above.

Nine Months Ended September 30, 2025 Compared to the Nine Months Ended September 30, 2024

Nine Months Ended

September 30,

(in thousands)

OPERATING EXPENSES:

Research and Development

General and Administrative

TOTAL OPERATING EXPENSES

OPERATING LOSS

Interest Income

Research and Development Expenses

Research and development expenses were $1.6 million for the nine months ended September 30, 2025 and $4.6 million for the nine months ended September 30, 2024, a decrease of $3.0 million due to $0.7 million decrease in manufacturing related costs and $2.3 million decrease in consulting fees as the prior year had higher expenses related to Phase 2b and Phase 3 preparation costs.

Research and development expenses were $0.3 million for the three months ended March 31, 2026 and $0.6 million for the three months ended March 31, 2025, a decrease of $0.3 million due to $0.1 million decrease in manufacturing related costs and $0.2 million decrease in consulting fees as the prior year had higher expenses related to Phase 2b and Phase 3 preparation costs.

General and Administrative Expenses

General and administrative expenses were $4.9 million for the nine months ended September 30, 2025 and $6.8 million for the nine months ended September 30, 2024, a decrease of $1.9 million.

The decrease was primarily due to $0.6 million decrease in professional fees and $1.3 million decrease in share-based compensation related costs.

Net loss was $6.4 million for the nine months ended September 30, 2025, and $11.3 million for the nine months ended September 30, 2024, a decrease of $4.9 million, due to the reasons stated above.

General and administrative expenses were $1.4 million for the three months ended March 31, 2026 and $1.6 million for the three months ended March 31, 2025, a decrease of $0.2 million .

The decrease was primarily due to $0.1 million decrease in professional fees and $0.1 million decrease in legal fees.

Net loss was $1.7 million for the three months ended March 31, 2026, and $2.1 million for the three months ended March 31, 2025, a decrease of $0.4 million, due to the reasons stated above.

Liquidity and Capital Resources

Since inception, we have generated no revenue from operations and we have incurred cumulative losses of approximately $73.7 million as of September 30, 2025.

Since inception, we have generated no revenue from operations and we have incurred cumulative losses of approximately $77.0 million as of March 31, 2026 .

We have funded our operations primarily from equity issuances.

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On May 18, 2023, we completed a registered direct offering and a concurrent private placement resulting in net proceeds of approximately $3.5 million after deducting placement agents fee of $0.2 million and offering costs of $0.2 million.

On November 15, 2023, we entered into a Sales Agreement and established the ATM Program, pursuant to which we may offer and sell, from time to time, through A.G.P./Alliance Global Partners, as sales agent, shares of our common stock having an aggregate offering price of up to $17.0 million.

Under the ATM Program, we raised net proceeds of approximately $ 8.8 million after deducting sales agent commissions and other related expenses of $0.4 million.

On November 15, 2023, we entered into a Sales Agreement and established an “At-the-Market” program, pursuant to which we may offer and sell, from time to time, through A.G.P./Alliance Global Partners, as sales agent, shares of our common stock having an aggregate offering price of up to $17.0 million (the “ATM Program”) .

Under the ATM Program, we raised net proceeds of approximately $ 8.8

million after deducting sales agent commissions and other related expenses of $0.4 million.

As of January 6, 2025, we suspended the ATM Program.

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In March 2025, we completed a registered direct offering and concurrent private placement for net proceeds of $0.9 million after deducting placement agent fees and offering expenses.

On May 8, 2025, we entered

into the ELOC with Lincoln Park, pursuant to which Lincoln Park committed to purchase up to $12.0 million in shares of our common stock.

Under the ELOC, we raised net proceeds of approximately $2.3 million after deducting related fees and expenses as of September 30, 2025.

On May 8, 2025, we entered into the ELOC with Lincoln Park, pursuant to which Lincoln Park committed to purchase up to $12.0 million in shares of our common stock.

Under the ELOC, we raised net proceeds of approximately $ 6.9 million after deducting related fees and expenses as of March 31, 2026.

On June 17, 2025, we entered into a warrant inducement agreement with existing warrant holders, receiving net proceeds of approximately $2.5 million after deducting fees and transaction expenses.

Based upon our lack of revenue expected for the foreseeable future, and because of numerous risks and uncertainties associated with the research, development and future commercialization of our product candidates, we are unable to estimate with certainty the amounts of increased capital outlays and operating expenditures associated with our anticipated clinical trials and development activities.

As of September 30, 2025, we had working capital of $3.6 million, consisting primarily of $5.9 million of cash and $0.2 million of prepaid expenses and other receivable, offset by approximately $2.5 million of accounts payable and accrued expenses.

As of March 31, 2026, we had working capital of $7.0 million, consisting primarily of $9.3 million of cash and $0.3 million of prepaid expenses and other receivable, offset by approximately $2.5 million of accounts payable and accrued expenses.

The following table sets forth selected cash flow information for the periods indicated:

Nine Months Ended

September 30,

Three Months Ended

(in thousands)

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Financing activities

Net increase (decrease) in cash

Net increase in cash

Net Cash Used in Operating Activities

Net cash used in operating activities was $5.6 million for the nine months ended September 30, 2025.

The net loss was greater than the net cash used in operating activities by $0.8 million, primarily attributable to share-based compensation and share-based vendor payments of $1.2 million offset by decrease in accounts payable and accrued expenses of $0.4 million.

Net cash used in operating activities was $8.1 million for the nine months ended September 30, 2024.

The net loss was greater than the net cash used in operating activities by $3.2 million, primarily attributable to share-based compensation and share-based vendor payments of $2.9 million and increase in accounts payable and accrued expenses of $0.3 million.

Net cash used in operating activities was $1.4 million for the three months ended March 31, 2026.

The net loss was greater than the net cash used in operating activities by $0.3 million, primarily attributable to share-based compensation and share-based vendor payments of $0.3 million.

Net cash used in operating activities was $2.1 million for the three months ended March 31, 2025.

The net loss was greater than the net cash used in operating activities by $0.1 million, primarily attributable to share-based compensation and share-based vendor payments of $0.4 million offset by a decrease in accounts payable and accrued expenses of $0.3 million.

Net Cash Provided by Financing Activities

Net cash provided from financing activities was $7.8 million for the nine months ended September 30, 2025, which was attributable to the net proceeds from the January and March Registered Direct Offerings, 2025 warrant exercise and sales related to the equity line of credit purchase agreement.

Net cash provided from financing activities was $6.4 million for the nine months ended September 30, 2024, which was primarily attributable to the ATM Program.

Net cash provided from financing activities was $3.1 million for the three months ended March 31, 2026, which was attributable to the sales related to the equity line of credit purchase agreement.

Net cash provided from financing activities was $3.0 million for the three months ended March 31, 2025, which was primarily attributable to the net proceeds from the January 2025 and March 2025 Registered Direct Offerings (as defined in Note-4 to our condensed interim financial statements contained in Item 1 of this Quarterly Report on Form 10-Q).

Critical Accounting Policies and Estimates

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On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and share-based compensation.

We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, the

results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

Our actual results may differ from these estimates under different assumptions or conditions.

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Subject to certain conditions set forth in the JOBS Act, we are entitled to rely on certain exemptions as an emerging growth company;

we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b), (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the

auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation-related items.

we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial

reporting pursuant to Section 404(b), (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation-related items.

These exemptions will apply for a period of five years following the completion of our IPO or until we no longer meet the requirements of being an emerging growth company, whichever is earlier.

Recent Accounting Pronouncements Not Yet Adopted

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures , which expands the disclosures required for income taxes.

This ASU is effective for fiscal years beginning after December 15, 2024, and we currently believe that it will not have a material impact on our disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures , to improve transparency in financial reporting by requiring entities to present more detailed information about the nature of expenses included within the Income Statement.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis