ACXP 10-K & 10-Q changes, risk factors and insider trading

Our independent registered public accounting firm noted in its report accompanying our financial statements for the fiscal year ended December 31, 20242025 that we had suffered a significant accumulated deficit and had negative operating cash flows and that the development and commercialization of our product candidates are expected to require substantial expenditures. We have not yet generated any material revenues from our operations to fund our activities, and are therefore dependent upon external sources for financing our operations. There can be no assurance that we will succeed in obtaining the necessary financing to continue our operations. As a result, our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. If we cannot successfully continue as a going concern, our stockholders may lose their entire investment in our common stock.

As of December 31, 2024,2025, we had approximately $3.7$7.6 million in cash. In June 2021, we completed the IPO for net cash proceeds of $14.8 million after deducting underwriting discounts and commissions and offering expenses. In July 2022, we completed a registered direct offering and concurrent private placement for net cash proceeds of $3.7 million after deducting placement agent fees and offering expenses. In May 2023, we completed a registered direct offering and concurrent private placement for net cash proceeds of $3.5 million after deducting placement agent fees and offering expenses. In November 2023, we entered into a Sales Agreement and established an “At-the-Market" offering (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. As of the year ended December 31, 2024,2025, we sold a total of 2,830,328141,516 shares of our common stock under the ATM Program, at a weighted-average price of $3.26$65.20 per share, raising $9.2 million of gross proceeds and net proceeds of $8.8 million after deducting commissions to the sales agent and other ATM Program related expenses. There remained approximately $7.8 million available for future sales of shares of common stock under the Sales Agreement. As of January 6, 2025, we suspended the ATM program. In January 2025, we completed a registered direct offering and concurrent private placement for net proceeds of $2.1 million after deducting placement agent fees and offering expenses. 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, $0.001 par value per share. Under the ELOC, we raised net proceeds of approximately $3.8 million after deducting related fees and expenses as of December 31, 2025. 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. We believe that, based upon our current operating plan, our existing capital resources, will not be sufficient to fund our anticipated operations for at least 12 months from the issuance of our financial statements for the year ended December 31, 2024.2025. Our future capital requirements and the period for which we expect our existing resources to support our operations may vary significantly from what we expect. Our monthly spending levels vary based on new and ongoing research and development and other corporate activities. Because the length of time and activities associated with successful research and development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities.

We cannot be certain that additional funding will be available on acceptable terms, or at all. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. Our ability to raise additional funding will depend on financial, economic and market conditions and other factors, over which we may have no or limited control, including the conflict between Russia and UkraineUkraine, andgeopolitical tensions involving China, the conflict between the U.S., Israel and Iran and tensions in the Middle East between Israel and Hamas.East. In addition, our ability to obtain future funding when needed through equity financings, debt financings or strategic collaborations may be particularly challenging in light of the uncertainties and circumstances regarding the COVID-19 pandemic. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives. We could be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to our product candidates in markets where we otherwise would seek to pursue development or commercialization ourselves.

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, contractors, suppliers, CROs, clinical sites, contract manufacturing organizations (“CMOs”) 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 duration and severity 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. Previously, our clinical trial operations were directly and indirectly adversely impacted, and could continue to be directly and indirectly adversely impacted, by the COVID-19 pandemic. A new pandemic or a resurgence of the COVID-19 pandemic could have an adverse economic impactsimpact to us.

The results of our operations could be adversely affected by general conditions in the global economy, the global financial markets and the global political conditions. The U.S. and global economies are facing growing inflation, higher interest rates and a potential recession. Furthermore, a severe or prolonged economic downturn, including a recession or depression resulting from public health crises such as a pandemic or ongoing political disruption such as the war between UkraineUkraine, andgeopolitical Russiatensions andinvolving China, the conflict involvingbetween the U.S., Israel and HamasIran and as well as the tensions in the Middle East could result in a variety of risks to our business, including weakened demand for our programs and development candidates, if approved, relationships with any vendors or business partners located in affected geographies and our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy or political disruption, including any international trade disputes, could also strain our manufacturers or suppliers, possibly resulting in supply disruption, or cause our customers to delay making payments for our potential products. Any of the foregoing could seriously harm our business, and we cannot anticipate all of the ways in which the political or economic climate and financial market conditions could seriously harm our business.

If the equity and credit markets deteriorate, it may make any necessary equity or debt financing more difficult to secure, more costly or more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could harm our growth strategy, financial performance and stock price and could require us to delay or abandon plans with respect to our business, including clinical development plans. Further, recent developments in the banking industry could adversely affect our business. If the financial institutions with which we do business enter receivership or become insolvent in the future, there is no guarantee that the Department of the Treasury, the Federal Reserve and the Federal Deposit Insurance Corporation, or FDIC, will intercede to provide us and other depositors with access to balances in excess of the $250,000 FDIC insurance limit, that we would be able to access our existing cash, cash equivalents and investments, that we would be able to maintain any required letters of credit or other credit support arrangements, or that we would be able to adequately fund our business for a prolonged period of time or at all, any of which could have a material adverse effect on our business, financial condition and results of operations. We cannot predict the impact that the high market volatility and instability of the banking sector more broadly could have on economic activity and our business in particular. In addition, there is a risk that one or more of our current service providers, manufacturers or other third parties with which we conduct business may not survive difficult economic times, including the ongoing conflict between Russia and Ukraine, geopolitical tensions involving China, the warconflict between the U.S., Israel and Hamas,Iran and as well as the tensions in the Middle East, the instability of the banking sector, and the uncertainty associated with current worldwide economic conditions, which could directly affect our ability to attain our operating goals on schedule and on budget.

Competitors may infringe our patents. To counter infringement or unauthorized use, we or our collaborators may be required to file infringement lawsuits that can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one of our patents is not valid, is unenforceable and/or is not infringed, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put any pending applications at risk of being interpreted narrowly and not issuing.being issued.

On FebruaryAugust 24,26, 2025, we received a letter from The Nasdaq Stock Market (“Nasdaq”) notifying us that forwe theregained precedingcompliance 31 consecutive business days our common stock did not maintain a minimum closing bid price of $1.00 per share as required bywith Nasdaq Listing Rule 5550(ab)(2) (the “Minimum Bid Price Requirement”1).

Should we fail to satisfy additional continued listing requirements, such as the corporate governance requirementsrequirements, Stockholders’ Equity Requirement, or the Minimum Bid Price Requirement, Nasdaq may take steps to delist our common stock. Such a delisting would likely have a negative effect on the price of our common stock, and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below Nasdaq’s Minimum Bid Price Requirement or prevent future non-compliance with the Nasdaq’s listing requirements.

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 stageearly-stage antibiotic candidates that target Gram-positive bacteria for oral and/or parenteral treatment of infections caused by Clostridium difficile (“C. difficile”), Enterococcus (including vancomycin-resistant strains (“VRE”)), Staphylococcus (including methicillin-resistant strains), and 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, methicillin-resistant Staphylococcus aureus (“MRSA”), vancomycin-resistant Enterococcus, penicillin-resistant Streptococcus pneumonia (“PRSP”), B. anthracis (anthrax) and other resistant bacteria.

We also have an early stageearly-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.PRSP and B. anthracis (anthrax).

On March 6, 2025, we, entered into a Securities Purchase Agreement (the “March Purchase Agreement”) with an institutional investor named therein (the “March Investor”), pursuant to which we agreed to issue and sell, in a registered direct offering by us directly to the March Investor (the “March Registered Offering”) (i) 2,150,000107,500 shares of common stock, par value $0.001 per share (the “Common Stock”), at a purchase price of $0.40$8.00 per share and (ii) pre-funded common stock purchase warrants (the “March Pre-Funded Warrants”) to purchase up to 595,00029,750 shares of Common Stock (the “March Pre-Funded Warrant Shares”) at a purchase price of $0.3999$7.998 per March Pre-Funded Warrant for aggregate gross proceeds of approximately $1.1 million, before deducting the placement agent fees and related offering expenses. As of December 31, 2025, all of the March Pre-Funded Warrants were exercised. We intend to use the net proceeds from the offering for working capital and other general corporate purposes.

In a concurrent private placement (the “March Private Placement” and together with the March Registered Offering, the “March Offering”), we agreed to issue to the Investor series F common warrants (the “Series F Warrants”) to purchase up to an aggregate of 8,235,000411,750 shares of Common Stock. The Series F Warrants will have an exercise price of $0.40$8.00 per share and will bewere exercisable commencing on theJuly effective17, date of stockholder approval of the issuance of the shares of Common Stock issuable upon exercise of the Series F Warrants (the “Stockholder Approval”)2025 and will expire twenty-four months following the date of Stockholder Approval. We will be obligated to obtain Stockholder Approval at the Company's annual meeting of stockholders on orJuly prior19, to the date that is 150 days following the closing date (the “Stockholder Meeting Deadline”). If Stockholder Approval is not obtained on or prior to the Stockholder Meeting Deadline, we are required to cause an additional stockholder meeting to be held every 60 days after the Stockholder Meeting Deadline until Stockholder Approval is obtained or the Series F Warrants are no longer outstanding.2027. The Series F Warrants and the shares of our Common Stock issuable upon the exercise of the Series F Warrants are not being registered under the Securities Act of 1933, as amended (the “Securities Act”), were not offered pursuant to the Registration Statement and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act, and Rule 506(b) promulgated thereunder.

On February 24, 2025, we received a letter from The Nasdaq Stock Market notifying us that for the preceding 31 consecutive business daysdays, 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.

Research and Development Expenses. Research and development expenses were $1.8 million for the year ended December 31, 2025, and $5.4 million for the year ended December 31, 2024, and $6.0 million for the year ended December 31, 2023, a decrease of $0.6$3.6 million due to a decrease in consulting fees of $1.6$2.6 million,million offset by increase inand manufacturing cost of $1.0 million.million as the prior year had higher expenses related to Phase 2b and Phase 3 clinical trial preparation costs.

General and Administrative Expenses. General and administrative expenses were $6.3 million for the year ended December 31, 2025, and $8.7 million for the year ended December 31, 2024, and $8.5 million for the year ended December 31, 2023.2024. General and administrative expenses increaseddecreased by approximately $0.2$2.4 million primarily due to a $0.4 million decrease in compensation costs, a $1.4 million decrease in share-based compensation costs and a $0.9 million decrease in professional fees, offset by a $0.3 million increase in legal fees, and $0.7 million increase in professional fees, offset by $0.6 million decrease in share based compensation costs and $0.2 million decrease in insurance costs.

Since inception, we have generated no revenue from operations and we have incurred cumulative losses of approximately $67.3$75.2 million as of December 31, 2024.2025. We have funded our operations primarily from equity issuances. We received net cash proceeds of approximately $12.9 million from equity financings closed between March 2018 and October 2020. On June 29, 2021, we completed our IPO resulting in net proceeds of approximately $14.8 million after deducting underwriter discounts of $1.4 million and offering costs of approximately $1.1 million. On July 27, 2022, we completed a registered direct offering and concurrent private placement resulting in net proceeds of approximately $3.7 million after deducting the placement agents commission of $0.3 million and offering costs of $0.2 million. On May 18, 2023, we completed a registered direct offering and a concurrent private placement resulting proceeds of approximately $3.5 million after deducting the 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 commission and other related expenses of $0.4 million. As of January 6, 2025, we suspended the ATM Program. In January 2025, we completed a registered direct offering and concurrent private placement for net proceeds of $2.1 million after deducting placement agent fees and offering expenses. 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 $3.8 million after deducting related fees and expenses as of December 31, 2025. 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.

To date, we have financed our operations principally through private placements of equity issuances, the IPO, registered direct offeringsofferings, the ATM Program and the ATMequity Program.line of credit purchase agreement.

On March 10, 2025, we completed a registered direct offering and a concurrent private placement, issuing 2,150,000107,500 shareshares of common stock, 595,00029,750 pre-funded warrants and Series F warrants to purchase 8,235,000411,750 shares of common stock for gross proceeds of approximately $1.1 million.

As ofThrough the yearATM ended December 31, 2024,Program, we sold a total of 2,830,328141,516 shares of its common stock under the ATM Program at a weighted-average price of $3.26$65.28 per share, raising $9.2 million of gross proceeds and net proceeds of $8.8 million, after deducting commissions to the sales agents and other ATM Program related expenses. There remainedremains approximately $7.8 million available for future sales of shares of common stock under the Sales Agreement. On January 6, 2025, we suspended the ATM program.

Net cash used in operating activities was $9.8$6.8 million for the year ended December 31, 2023,2025, primarily attributable to the net loss of $14.6$8.0 million, offset by share-based compensation of $3.2$1.2 million, share-based payments to vendors of $0.6$0.3 million and ana increasedecrease of $1.0$0.4 million in accounts payable and accrued expenses.

We are not profitable and have incurred significant losses in each period since our inception, including net losses of $1.7$3.9 million for the threesix months ended MarchJune 31,30, 2026 and $8.0 million for the year ended December 31, 2025. We have not commercialized any products and have never generated any revenue from product sales. We expect these losses to increase as we continue to incur significant research and development and other expenses related to our ongoing operations, seek regulatory approvals for our product candidates, scale-up manufacturing capabilities and hire additional personnel to support the development of our product candidates and to enhance our operational, financial and information management systems.

As of MarchJune 31,30, 2026, we had approximately $9.3$10.7 million in cash. In June 2021, we completed the IPO for net proceeds of $14.8 million after deducting underwriting discounts and commissions and offering expenses. In July 2022, we completed a registered direct offering and concurrent private placement for net proceeds of $3.7 million after deducting placement agent fees and offering expenses. In May 2023, we completed a registered direct offering and concurrent private placement for net proceeds of $3.5 million after deducting placement agent fees and offering expenses. In November 2023, we entered into a Sales Agreement and established an 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. We sold a total of 145,516 shares of our common stock under the ATM Program, at a weighted-average price of $65.20 per share, raising $9.2 million of gross proceeds and net proceeds of $8.8 million after deducting commissions to the sales agent and other ATM Program related expenses. As of January 6, 2025, we suspended the ATM Program. In January 2025, we completed a registered direct offering and concurrent private placement for net proceeds of $2.1 million after deducting placement agent fees and offering expenses. 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, $0.001 par value per share. Under the ELOC, we raised net proceeds of approximately $6.9$7.8 million after deducting related fees and expenses as of MarchJune 31,30, 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. In April 2026, we completed a registered direct offering and concurrent private placement for net proceeds of approximately $2.2$2.3 million after deducting placement agent fees and offering expenses.

We believe that, based upon our current operating plan, our existing capital resources will not be sufficient to fund our anticipated operations for at least 12 months from the issuance of our condensed interim financial statements for the threesix months ended MarchJune 31,30, 2026. Our future capital requirements and the period for which we expect our existing resources to support our operations may vary significantly from what we expect. Our monthly spending levels vary based on new and ongoing research and development and other corporate activities. Because the length of time and activities associated with successful research and development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities.

Our officers, directors and their affiliates currently collectively own 331,330339,579 shares of our common stock (on an as-converted basis) or approximately 9%7% of our outstanding shares of common stock (on an as-converted basis) as of MarchJune 31,30, 2026. Accordingly, if these stockholders were to choose to act together, they could have a significant influence over all matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions, such as a merger or other sale of our company or all or a significant percentage of our assets. This concentration of ownership could limit your ability to influence corporate matters and may have the effect of delaying or preventing a third party from acquiring control over us.

Should we fail to satisfy additional continued listing requirements, such as the corporate governance requirements, Stockholders’ Equity Requirement, or the Minimum Bid Price and MVLS Requirement, Nasdaq may take steps to delist our common stock. Such a delisting would likely have a negative effect on the price of our common stock, and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below Nasdaq’s Minimum Bid Price Requirement or prevent future non-compliance with the Nasdaq’s listing requirements.

In a concurrent private placement to the April 2026 Registered Offering, the Company issued unregistered short-term24 month term warrants to purchase up to 1,650,170 shares of Common stock. The short-termThese warrants have an exercise price of $2.78 per share, were immediately exercisable upon issuance and will expire twenty-fouron monthsMay following11, the effective date of the registration statement registering the resale of the share of common stock underlying the short-term warrants.2028.

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 arebegan scheduledin tothe beginsecond later this month,quarter, 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.

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,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). In addition, we met the minimum stockholders’ equity threshold of $2.5 million under Listing Rule 5550(b)(1). We are now in full compliance with all Nasdaq continued listing requirements and our common stock willis remaincurrently listed and traded on the Nasdaq Stock Market.

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$8.7 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. On May 4, 2026, we filed with the SEC a registration statement (the “Fourth Registration Statement” and, together with the First Registration Statement and the Second Registration Statement and the Third Registration Statement, the “Prior Registration Statements”) on Form S-1 (Registration No. 333-295527) to register up to 1,300,000 shares of common stock. To date, we have issued and sold 1,835,0002,754,359 shares of common stock pursuant to the Prior Registration Statements for aggregate gross proceeds of $7.3$8.7 million.

In March 2020, the World Health Organization declared the outbreak of COVID 19,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.

Three Months Ended MarchJune 31,30, 2026 Compared to the Three Months Ended MarchJune 31,30, 2025

The following table presents a summary of the changes in our results of operations for the three months ended MarchJune 31,30, 2026 compared with the three months ended MarchJune 31,30, 2025:

Research and development expenses were $0.3$1.1 million for the three months ended MarchJune 31,30, 2026 and $0.6$0.5 million for the three months ended MarchJune 31,30, 2025, aan decreaseincrease of $0.3$0.6 million due to $0.1$0.3 million decreaseincrease in manufacturing related costs and $0.2$0.3 million decreaseincrease in consulting fees as thea priorresult yearof hadcosts higherassociated expenseswith relatednew torecurrent PhaseCDI 2btrial and Phase 3 preparation costs.program.

General and administrative expenses were $1.4$1.2 million for the three months ended MarchJune 31,30, 2026 and $1.6$1.7 million for the three months ended MarchJune 31,30, 2025, a decrease of $0.2$0.5 million. The decrease was primarily due to $0.1a $0.3 million decrease in professional feesfees, anda $0.1 million decrease in legal fees.fees and a $0.1 million decrease in share-based compensation expense.

Net loss was $1.7$2.3 million and $2.2 million for the three months ended MarchJune 31,30, 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.respectively.

Since inception, we have generated no revenue from operations and we have incurred cumulative losses of approximately $77.0$79.2 million as of MarchJune 31,30, 2026. We have funded our operations primarily from equity issuances. We received net proceeds of approximately $12.9 million from equity financings closed between March 2018 and October 2020. On June 29, 2021, we completed our IPO resulting in net proceeds of approximately $14.8 million after deducting underwriter discounts of $1.4 million and offering costs of approximately $1.1 million. On July 27, 2022, we completed a registered direct offering and concurrent private placement resulting in net proceeds of approximately $3.7 million after deducting placement agents fees of $0.3 million and offering costs of $0.2 million. 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 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. In January 2025, we completed a registered direct offering and concurrent private placement for net proceeds of $2.1 million after deducting placement agent fees and offering expenses. 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 $6.9$7.8 million after deducting related fees and expenses as of MarchJune 31,30, 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. In April 2026, we completed a registered direct offering and concurrent private placement for net proceeds of approximately $2.3 million after deducting placement agent fees and offering expenses.

As of MarchJune 31,30, 2026, we had working capital of $7.0$8.2 million, consisting primarily of $9.3$10.7 million of cash and $0.3 million of prepaid expenses and other receivable, offset by approximately $2.5$2.8 million of accounts payable and accrued expenses.

Net cash used in operating activities was $2.1$3.1 million for the threesix months ended MarchJune 31,30, 2025.2026. The net loss was greater than the net cash used in operating activities by $0.1$0.8 million, primarily attributable to share-based compensation and share-based vendor payments of $0.4$0.6 million offsetand by a decreaseincrease in accounts payable and accrued expenses of $0.3$0.4 million, offset by increase in other receivable and prepaid expenses of $0.2 million.

Net cash provided from financing activities was $3.0$6.2 million for the threesix months ended MarchJune 31,30, 2025,2026, which was primarily attributable to the netsales proceedsrelated fromto the Januaryequity 2025line of credit purchase agreement and Marchthe 2025April 2026 Registered Direct OfferingsOffering (as defined in Note-4 to our condensed interim financial statements contained in Item 1 of this Quarterly Report on Form 10-Q).