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

Completion of the Merger is subject to the satisfaction or waiver of a number of conditions, as set forth in the Merger Agreement, including the approval by the CSRC, approval by our stockholders, which was received in 2025, approval by Nasdaq of our application for the initial listing of our common stock to be issued in connection with the Merger, and other customary closing conditions. There can be no assurance that we and Cullgen will be able to satisfy the closing conditions or that closing conditions beyond their control will be satisfied or waived. For a discussion of the conditions to the completion of the Merger, see the section titled “The Merger Agreement-Conditions to the Completion of the Merger” beginning on page 147 of the proxy statement/prospectus included in the registration statement on Form S-4, filed with the SEC on February 14, 2025 (the “proxy statement/prospectus”). If the conditions are not satisfied or waived, the Merger may not occur or may not be completed within the expected timeframe, and we and Cullgen each may materially and adversely lose some or all of the potential benefits that we and Cullgen expect to achieve as a result of the Merger and could result in additional transaction costs or other effects associated with uncertainty about the Merger. In addition, pursuanton toAugust 1, 2025, Pulmatrix and Cullgen, as provided for in the Merger Agreement, wemutually mayagreed to extend the originally“End scheduledDate”, Enda term defined Date (defined in the Merger AgreementAgreement, asby 60 days from August 13, 2025)2025, by up to 60 calendar days (to October 12, 2025)2025. The Merger Agreement does not have a defined term and does not terminate on the “End Date”. The “End Date” is simply the date at which certain termination options become available to either party. Moreover, each of we and Cullgen has incurred and expects to continue to incur significant expenses related to the Merger, such as legal and accounting fees, some of which must be paid even if the Merger is not completed.

We have never paid and, otherexcept thanthe potential Cash Dividend in connection with the MergerMerger, with Cullgen, doesdo not intend to pay any cash dividends in the foreseeable foreseeable future.

All of our research and development programs are in developmental stages. One or more of our product candidates may fail to meet safety and efficacy standards in human testing, even if those product candidates are found to be effective in animal studies. To develop and commercialize inhaled therapeutic treatment for allergic bronchopulmonary aspergillosis (“ABPA”), acute migraine, and other iSPERSE™-based product candidates, we must provide the FDA and foreign regulatory authorities with human clinical and non-clinical animal data that demonstrate adequate safety and effectiveness. To generate these data, we will have to subject our product candidates to substantial additional research and development efforts, including extensive non-clinical studies and clinical testing. Our approach to drug development may not be effective or may not result in the development of any drug. Currently ourOur development efforts arehave been primarily focused on PUR3100, PUR1800 and PUR1900. Even if PUR3100, PUR1800 and PUR1900 or our other product candidates are successful when tested in animals, such success would not be a guarantee of the safety or effectiveness of such product candidates in humans. It can take several years for a product to be approved and we may not be successful in bringing any therapeutic candidates to the market. A new drug may appear promising at an early stage of development or after clinical trials and never reach the market, or it may reach the market and not sell, for a variety of reasons. For example, the drug may:

In the United States, we will be subject to various federal and state health care “fraud and abuse” laws, including anti-kickback anti-kickback laws, false claims laws and other laws intended to reduce fraud and abuse in the healthcare industry, which could affect us, particularly upon successfulif commercializationwe decide to resume development of and successfully commercialize any of our productsproduct candidates that receive regulatory approval in the United States. The federal Anti-Kickback Statute makes it illegal for any person, including a prescription drug manufacturer (or a party acting on our behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration in exchange for or to induce the referral of an individual for, or the purchase, order or recommendation of, any good or service, including the purchase, order or prescription of a particular drug for which payment may be made under a federal health care program, such as Medicare or Medicaid. Under federal government regulations, some arrangements, known as safe harbors, are deemed not to violate the federal Anti-Kickback Statute. However, these laws are broadly written, and it is often difficult to determine precisely how the law will be applied in specific circumstances. Accordingly, it is possible that our practices may be challenged under the federal Anti-Kickback Statute. False claims laws prohibit anyone from knowingly and willfully presenting or causing to be presented for payment to third-party payors, including government payors, claims for reimbursed drugs or services that are false or fraudulent, claims for items or services that were not provided as claimed, or claims for medically unnecessary items or services. Cases have been brought under false claims laws alleging that off-label promotion of pharmaceutical products or the provision of kickbacks has resulted in the submission of false claims to governmental healthcare programs. Under the Health Insurance Portability and Accountability Act of 1996, we are prohibited from from knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private payors, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in in connection with the delivery of or payment for healthcare benefits, items or services. Violations of fraud and abuse laws may be punishable punishable by criminal and/or civil sanctions, including fines, penalties and/or exclusion or suspension from federal and state healthcare programs such as Medicare and Medicaid and debarment from contracting with the U.S. government. In addition, private individuals have the ability to bring actions on behalf of the government under the federal False Claims Act as well as under the false claims laws of several states.

Further, the healthcare regulatory environment has seen significant changes in recent years and is still in flux. Legislative initiatives to modify, limit, replace, or repeal the ACA and judicial challenges have continued for over a decade. However, as of the Supreme Court’s ruling ordering the dismissal of, arguably, the most promising case challenging the ACA to-date on June 17, 2021, it appears thatAdditionally, the ACA will remain in-effect in its current form for the foreseeable future; however, we cannot predict what additional challenges may arise in the future, the outcome thereof, or the impact any such actions may have on our business. The Biden administration also introduced various measures in 2021 focusing on healthcare and drug pricing, in particular. For example, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace, which began on February 15, 2021, and remained open through August 15, 2021. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. On the legislative front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part, eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source drugs and innovator multiple source drugs, beginning January 1, 2024. And, in July 2021, the Biden administration released an executive order entitled, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response, on September 9, 2021, HHS released a “Comprehensive Plan for Addressing High Drug Prices” that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. And, in August 2022, the Inflation Reduction Act (“IRA”) was signed into law, which will, which, among other things, allowallows U.S. Department of Health and Human Services (“HHS”) to negotiate the selling price of certain drugs and biologics that the Centers for Medicare & Medicaid Services (“CMS”) reimburses under Medicare Part B and Part D, although only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for biologics) can be selected by CMS for negotiation, with the negotiated price taking effect two years after the selection year. The negotiated prices, which will first becomebecame effective in January 1, 2026, will be capped at a statutory ceiling price. Beginning Beginning in October 2023, the IRA also began penalizing drug manufacturers that increase prices of Medicare Part B and Part D drugs at a rate greater than the rate of inflation. The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as as opposed to regulation, for the initial years. Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties. The IRA also extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. Additionally, in December 2023,Since the Biden-Harrisenactment Administrationof announcedthe furtherIRA, several pharmaceutical manufacturers and other industry stakeholders have initiated and continue to pursue lawsuits challenging the constitutionality and implementation of the IRA’s drug price negotiation provisions. It is uncertain how the drug pricing provisions imposed by the IRA, or results on any related initiatives underlitigation, will impact the IRAbroader topharmaceutical industry loweror prescriptionour costs and increase competition with help from HHS, the DOJ, and the FTC.business.

There is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the U.S. or the effect of any future legislation or regulation. Furthermore, we cannot yet assess the future impact that President Trump’s second term will have on healthcare programs and regulations or the pharmaceutical industry in general. However, it is possible that such initiatives could have an adverse effect on our ability to obtain approval and/or successfully commercialize productsany of our product candidates should we decide to resume their development in the U.S. in the future, as applicable.future.

After a comprehensive review of strategic alternatives, including identifying and reviewing potential candidates for a strategic transaction, on November 13, 2024, we entered into anthe Agreement and Plan of Merger and ReorganizationReorganization, as amended by Amendment No. 1 (“Amendment No. 1”) thereto on April 7, 2025 (as amended by Amendment No. 1, the “Merger Agreement”), bypursuant andto which, among amongother Pulmatrix,matters, PCL Merger Sub, Inc., aour Delaware corporation and ourdirect wholly owned subsidiary of (“Merger Sub I”), PCL Merger Sub II, LLC, a Delaware limited liability company and our wholly owned subsidiary (“Merger Sub II” and together with Merger Sub I, “Merger Subs”) and Cullgen Inc., a Delaware corporation (“Cullgen”), pursuant to which, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, among other things, Merger Sub I will merge with and into Cullgen, with Cullgen surviving the merger as the surviving corporation (the “First Merger”) and as part of the same overall transaction, Cullgensubsidiary, will merge with and into MergerCullgen SubInc. II, (“Cullgen”), with MergerCullgen Sub II continuingsurviving as our wholly owned subsidiary and the surviving corporation of the merger (the “Second Merger” and together with the First Merger, the “Merger”). The Merger Merger Agreement was unanimously approved by our board of directors (the “Board” or “board of directors”),directors, which resolved to recommend approval of the Merger Agreement to our stockholders.

Our future operations are highly dependent on the success of the Merger and there can be no assurances that the Merger will be successfully consummated. There can be no assurance that the strategic review process or any transaction relating to a specific asset, including the Merger and any asset sale, will result in the Companyus pursuing such a transaction, or that any transactions, if pursued, will be completed on on terms favorable to the Companyus and itsour stockholders in the existing Pulmatrix entity or any possible entity that results from a combination of of entities. If the strategic review process is unsuccessful, and if the Merger is not consummated, the Pulmatrix board of directors may may decide to pursue a dissolution and liquidation of the Company.

Our current pipeline of clinical assets is aligned to this goal and includes iSPERSE™-based therapeutic candidatescandidates, which target the prevention and treatment of a range of diseases, including CNS disorders and pulmonary diseases. These therapeutic candidates include include PUR3100 for the treatment of acute migraine, PUR1800 for the treatment of acute exacerbations of chronic obstructive pulmonary disease disease (“AECOPD”), and PUR1900 for the treatment of ABPA in patients with asthma and in patients with cystic fibrosisfibrosis. (“CF”). Each program is enabled by its unique iSPERSE™ formulation designed to achieve specific therapeutic objectives.

WeIn connection with the Merger, we are exploring opportunities to monetize these clinical assets inand connectionhave withpaused the Merger.development of these product candidates. Continued development of these candidates, if that were to occur, would be contingent on securing additional funding and would require significant expenditures to advance. Thereafter, if development of such product candidates were to be continued and successfully advanced (of which there can be no assurance), it would be necessary to seek and obtain marketing approval to commercialize such product candidates, which could be expected to require the expenditure of significant additional resources and expenses related to regulatory, product sales, medical affairs, marketing, manufacturing and distribution.

In 2020, we developed PUR3100, the iSPERSE™ formulation of DHE, for the treatment of acute migraine. Currently DHE is only available as subcutaneous, intravenous infusion or intranasal delivery. If approved for commercialization, PUR3100 has the opportunity to be the first orally inhaled DHE treatment for acute migraine and be an alternative to other acute therapies. Given the oral inhaled route route of delivery, PUR3100 is anticipated to provide rapid relief from the rapid onset of migraine symptoms and provide a favorable tolerability profile.

Our interactions with the FDA have indicated that, inas additionpart to the plannedof Phase 2 and Phase 3 studies, long-term safety should be assessed in a minimum of one hundred patients for six months of dosing and fifty patients for twelve months of dosing. The FDA also confirmed that it will be necessary to perform a safety study administering PUR3100 to otherwise healthy patients with asthma before an NDA is submitted.

The completed Phase 1 study demonstrated optimal pharmacokinetics and improved tolerability of PUR3100 compared to IV DHE. The Phase 1 trial was a randomized, double-dummy, double-blinded design to assesses the safety, tolerability, and pharmacokinetics (PK) of three dose groups treated with inhaled PUR3100 with intravenous (IV) placebo, compared to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo in healthy volunteers. All doses of PUR3100 were generally well tolerated with a lower incidence of nausea (21% vs. 86%), vomiting (0% vs. 29%), and headache (16% vs. 57%) compared to IV DHE. The PK profile of PUR3100 versus IV DHE was characterized by a similar mean time to Cmax (5 vs. 5.5 min), with reduced AUC0–2h (1120–4320 vs. 6340 ng*h/mL), and a lower Cmax (3620–14,400 vs. 45,000 ng/mL). All doses of PUR3100 were associated with mean Cmax above the minimum level required to achieve efficacy (1000 pg/mL).

We completed a Phase 1b safety, tolerability, and pharmacokinetics of PUR1800 forin patients with stable moderate-severe COPD. Topline data waswere delivered in the first quarter of 2022 and presented at the American Academy of Allergy, Asthma and Immunology conference in the first quarter of 2023.

We completed all Phase 2b wind down activities in the third quarter of 2024. As such, we no longer bear further financial responsibility for the commercialization and development with respect to the Product in the Cipla Territory, with such commercialization and development expenses of the Product in the Cipla Territory to be borne at Cipla’s sole cost and expense after January 6, 2024. We will receive 2% royalties on any potential future net sales by Cipla outside the United States. Within the United States, we and Cipla will seek to monetize PUR1900, our inhaled iSPERSE™ formulation of the antifungal drug itraconazole for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need.

To date, we have not generated any product sales. RevenuesNo revenues were recognized for the yearsyear ended December 31, 20242025. andRevenue 2023recognized for the year ended December 31, 2024, were primarily generated from the Cipla Agreement as related to our PUR1900 program, for which wind down activities have been completed.

We expense research and development costs to operations as incurred. Research and development activities arehave been central to our business model. We have utilized a combination of internal and external efforts to advance product development from early-stage work to clinical trial manufacturing and clinical trial support. External efforts have included work with consultants and substantial work at CROscontract research and CMOs.manufacturing organizations. We have historically supported an internal research and development team and facility for our pipeline and other potential development programs, however following the closing of the transaction with MannKind Corporation (“MannKind” and such transactions, the “MannKind Transaction in the third quarter of 2024,”) in whichthe year ended December 31, 2024, the majority of our research and development employees were terminated and our facility lease was assigned to MannKind,MannKind. Going forward, we expect to utilize external resources for further development. Additionally, a Master Services Agreement between the Company and MannKind calls for MannKind to provide certain development services to the Company, including but not limited to, activities to develop dry powder formulations using iSPERSE™.

Our significant accounting policies are described in the notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K. WeAs believewe wound down ongoing clinical programs, in the followingyear areended ourDecember 31, 2025, we have no critical accounting estimates which involve a significant level of uncertainty at the time the estimate was made, andnor estimates for which changes in them have had or are reasonably likely to have a material effect on our financial condition or results of operations.

Research and development expenses — Research and development expenses were less than $0.1 million for the year ended December 31, 2025, as compared to $7.2 million for the year ended December 31, 2024, as compared to $15.5 million for the year ended December 31, 2023, a decrease of approximately $8.4$7.1 million. The decrease was primarily due to decreased spend of $3.9$5.0 million inless costs related to our PUR1900 program, $2.2 million of lab facilities, contractorsemployment and other operating costs,costs $1.4following the MannKind Transaction and $2.1 million less cost incurred on the PUR1900 program, for which the winding down of employmentthe costs,Phase and2b $0.8clinical milliontrial inwas costscompleted relatedduring tothe ouryear PUR3100ended program.December 31, 2024.

General and administrative expenses — General and administrative expenses were $5.1 million for the year ended December 31, 2025, as compared to $7.8 million for the year ended December 31, 2024, as compareda to $6.5 million for the year ended December 31, 2023, an increasedecrease of approximately $1.3$2.7 million. The increasedecrease was primarily due to increased$2.9 spendmillion of $1.0decreased million in legalemployment and professionalother services and $0.4 million in employmentoperating costs, partially offset by a decrease$0.2 million of $0.1increased millioncosts inrelated rentto the and other operating costs.Merger.

Loss on MannKind Transaction — Loss on MannKind Transaction was $2.6 million on certain assets held for sale as of June 30, 2024 and disposed of during the three monthsyear ended December September 30,31, 2024, in connection with the assignment of our long-term lease of our Bedford facility pursuant to those certain agreement by and between us and MannKind Corporation and Cobalt Propco 2020, LLC (the “MannKind Transaction”),. as compared with noNo such loss occurred for the year ended December 31, 2023.2025.

No net cash was used in or provided by financinginvesting activities for the year ended December 31, 2024.2025.

Net cash providedused byin financinginvesting activities for the year ended December 31, 20232024 resultedwas fromdue proceedsto from the issuancepurchases of commonproperty stock, netand of issuance costs, under the Sales Agreement (as defined below).equipment.

During the yearyears ended December 31, 2025 and 2024, no shares of the Company’s common stock were sold under the Sales Agreement.

The Company is subject to risks and uncertainties including, should it resume development of its product candidates, risks and uncertainties common to companies in the biopharmaceutical industry, including but not limited to, risks associated with completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Should the Company resume development of its product candidates, significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization, would be required. These efforts would require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, should the Company resume development of its product candidates, it is uncertain when, if ever, the Company would realize revenue from product sales. Additionally, recent changes to U.S. policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, tariffs, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business.

Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described in Part I, Item 1A under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, in addition to the risk factors below and incorporated herein by reference and other information included in this Quarterly Report on Form 10-Q before making an investment decision regarding our common stock. If any of these risks actually occur, our business, financial condition, or operating results would likely suffer, possibly materially, the trading price of our common stock could decline, and you could lose part or all of your investment.

Our unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As of MarchJune 31,30, 2026, our cash and cash equivalents balance was approximately $3.3$2.2 million, with an additional $0.7 million in restricted cash.

Our business could be adversely affected by unstable economic and political conditions within the United States and foreign jurisdictions and geopolitical conflicts, such as the conflicts in Venezuela, between Russia and Ukraine or in the Middle East. While we do not have any customer or direct supplier relationships in impacted areas at this time, the current military conflict, and related sanctions, as well as export controls or actions that may be initiated by nations including the United States, Iran, the European Union or Russia (e.g., potential cyberattacks, disruption of energy flows, etc.) and other potential uncertainties could adversely affect our business and/or our supply chain, business partners, employees or customers, and interrupt our ability to supply products, or otherwise adversely impact our business.

Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to provide a reader of our financial statements with a narrative from the perspective of our management on our financial condition, results of operations, liquidity, and certain other factors that may affect our future results. The information set forth below should be read in conjunction with the condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q, as well as the audited consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and amended on June 16, 2026 (the “Annual Report”). Unless stated otherwise, references in this Quarterly Report on Form 10-Q to “us,” “we,” “our,” or our “Company” and similar terms refer to Pulmatrix, Inc., a Delaware corporation and its subsidiaries.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Research and development expenses — Research and development expenses were less than $0.1 million for both the three months ended MarchJune 31,30, 2026, and 2025. All clinical development is currently on hold while we work to license or monetize our clinical assets.

General and administrative expenses — General and administrative expenses were $1.3$1.0 million for the three months ended MarchJune 31,30, 2026, as compared to $1.8$1.5 million for the three months ended MarchJune 31,30, 2025, a decrease of approximately $0.5 million. The decrease was primarily due to higherlower costs incurred in the three months ended March 31, 2025,as related to thesoftware preparationsubscriptions, legal and filingpatent of a registration statementcosts, and amendmentsbusiness theretodevelopment onand Form S-4 with the SEC.merger-related activities.

Through MarchJune 31,30, 2026, we incurred an accumulated deficit of $303.5$304.5 million, primarily as a result of expenses incurred through a combination of research and development activities related to our various product candidates and general and administrative expenses supporting those activities. We have financed our operations since inception primarily through the sale of preferred and common stock, the issuance of convertible promissory notes, term loans, and collaboration and license agreements. Our total cash and cash equivalents balance as of MarchJune 31,30, 2026, was $3.3$2.2 million plus $0.7 million in restricted cash.

As of MarchJune 31,30, 2026, we had $3.3$2.2 million in cash and cash equivalents, as well as $0.7 million in restricted cash that would become unrestricted following consummation of the Merger or upon any termination of the Merger Agreement in accordance with its terms. We expect to incur significant costs in connection with the Merger and even if the Merger is ultimately not consummated, including legal and professional services costs related to filing registration statements with the SEC and obtaining shareholder approval.

In order to continue development of our programs, we would need to secure substantial additional funding in the future, from one or more equity or debt financings, collaborations, or other sources. Additional funding may not be available to us on acceptable terms, or at all. Contingent on securing additional funding and continuing development of our programproduct candidates, we anticipate that we would continue to incur losses over the next several years due to development costs associated with our iSPERSE™ pipeline programs.

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026, was $1.1$2.2 million, which was primarily the result of $1.2$2.2 million million of net loss, partially offset by $0.1 million of cash flows associated with changes in operating assets and liabilities.loss.

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2025, was $1.8$3.7 million, which was primarily the result of $1.8$3.4 million million of net lossloss, and $0.1 million in net non-cash adjustments, partially offset by $0.1$0.3 million of cash outflows associated with changes in operating assets and liabilities.liabilities and less than $0.1 million in net non-cash adjustments.

No net cash was used in investing activities for the threesix months ended MarchJune 31,30, 2026.

Net cash provided by financing activities was approximately $1.0 million for the threesix months ended MarchJune 31,30, 2026, resulting from the $1.0 million sale of Series B Convertible Preferred Stock during the period.period, Issuancenet costsof attributable$50 tothousand thisof saleissuance have not yet been paid.costs.

In connection with the entry into the Merger Agreement, we entered into a Securities Purchase Agreement, dated as of March 26, 2026, with an affiliate of Eos (the “Buyer”), pursuant to which we agreed to issue and sell to the Buyer in a private placement an aggregate of 1,000 shares of Series B Convertible Preferred Stock for aggregate gross proceeds of $1.0 million, which we received during the three months ended March 31, 2026. TheWe Company deliveredissued the shares of Series B Convertible Preferred Stock to the Buyer on April 16, 2026.

During the threesix months ended MarchJune 31,30, 2026, and 2025, no shares of our common stock were sold under the Sales Agreement.

The Company is subject to risks and uncertainties including, should it resume development of its product candidates, risks and uncertainties common to companies in the biopharmaceutical industry, including but not limited to, risks associated with completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Should the Company resume development of its product candidates, significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization, would be required. These efforts would require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, should the Company resume development of its product candidates, it is uncertain when, if ever, the Company would realize revenue from product sales. Ongoing conflicts, such as those in Venezuela, between Russia and UkraineUkraine, and in the Middle East may adversely affect the economy and political conditions in the United States may be adversely affected, and in turn, affect our business and financial condition. Additionally, recent changes to U.S. policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, tariffs, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business.