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

Government contracts require ongoing funding decisions by governments. A substantial percentage of our potential future revenues are expected to come from government contracts. The majority of potential revenue under theany 19Cfuture BARDAU.S. Contract,Government thecontract Company'swill largestlikely procurement contract, isbe tied to options all but one of which have been exercised and the remaining optionthat may or may not be exercised at the sole discretion of BARDA.the OurU.S. inabilityGovernment. Failure of the U.S. Government to obtainexercise its options under a new procurement contract to supply TPOXX® to the U.S. Government could cause our business, financial condition, results of operations and prospects to sufferbe materially.materially harmed.

As of December 31, 2024,2025, all but one of the options to which most of the contract value of the 19C BARDA Contract is tied have been exercised. The one remaining option may or may not be exercised in the sole discretion of BARDA. There is no guarantee that the remaining option will be exercised, or if it is exercised, when such exercise will occur. In addition, there is no guarantee that we will be able to enter into a new contract to supply TPOXX® to the U.S. Government, or if we do, whether the potentialU.S. revenuesGovernment will exercise its options under such contractnew willprocurement be favorable.agreement. If the remaining option under the 19C BARDA Contract is not exercised, or we are unable to enter into a new contract to supply TPOXX® to the U.S. Government onfails favorableto terms,exercise its options under such new procurement agreement, if at all, including because levels of government expenditures and authorizations for biodefense decrease or shift to other programs, changes in the U.S. administration, or for any other reason,any, our business, financial condition, results of operations and prospects may suffer materially.

RemainingPreviously unexercisedexercised options under currentour government procurement contracts, including the 19C BARDA Contract, arewere predominately fixed-price.fixed price. We expect that ourany future contracts with the U.S. Government and foreign governments for TPOXX®, as well as contracts for other biodefense product candidates, would also be predominantly fixed-price arrangements with potential moderate annual increases. Under a fixed-price contract, we are required to deliver our products at a fixed price determined at the inception of the contract regardless of the actual costs we incur, and to absorb any costs incurred in satisfaction of our obligations. Our failure to secure financial terms, including price, generally consistent with our prior agreements, anticipate significant technical problems, estimate costs accurately or control costs during performance of a fixed-price contract could reduce the profitability of such contract, or if severe, cause a loss, which could in turn negatively affect our operating results.

A U.S. Government shutdown could negativelymaterially impactadversely affect our businessbusiness, results of operations, and liquidity.financial condition.

Each year, the U.S. Congress must pass all spending bills in the federal budget. If any such spending bill is not timely passed, a government shutdown may close many federally run operations, and halt work for federal employees unless they are considered essential or such work is separately funded by a continuing resolution or by industry. If a government shutdown were to occur, we could experience a delay in contract funding decisions by the government. Additionally, we could be materially harmed by any prolonged government shutdown.

The DCAA also reviews the adequacy of, and a contractor’s compliance with, its internal control systems and policies, including the contractor’s purchasing, property, estimating, compensation and management information systems. Any cost found to be improperly allocated to a specific contract will not be reimbursed, and such costs already reimbursed must be refunded. If an audit uncovers improper or illegal activities, a contractor may be subject to civil and criminal penalties and administrative sanctions, including termination of contracts, forfeiture of profits, suspension of payments, fines and suspension, debarment or prohibition from doing business with the U.S. Government. Such actions wouldcould materially damage our business and could also negatively affect our reputation.

The development and full commercialization of additional indications for TPOXX® in the U.S., such as use for smallpox post-exposure prophylaxis ("PEP") or treatment of mpox,, including the testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries and jurisdictions. We could fail to achieve FDA or other regulatory approval of certain indications of TPOXX®, or there could be delays in such approval of TPOXX®, or the approved labeling for such indications of TPOXX® may differ from expectations. For example, in connection with a potential FDA label expansion of oral TPOXX® for an indication covering PEP, we completed an immunogenicity trial in 2023 and originally targeted a supplemental NDA submission in 2024. Because samples from that trial are being reanalyzed by the U.S. Centers for Disease Control and Prevention,Prevention which has been impacted by recent U.S. Government shutdowns, the Company is now targeting a supplemental NDA submission inwithin the next twelve months. In addition, in 2024, data reported from two randomized, placebo-controlled clinical trials studying TPOXX® as a potential treatment for mpox, showed that TPOXX® did not demonstrate improved time to full lesion resolution compared to placebo, the primary endpoint in each trial.

Failure to obtain regulatory approval of certain indications for TPOXX® may prevent us from commercializing TPOXX® in the United States for the mpoxPEP indication or may prevent us from getting procurement orders from the U.S. Government for the post-exposure prophylaxis indication and may impact other regulatory authorities' future review of other indications of TPOXX®, which in turn, could adversely impact potential sales of TPOXX® in other countries, and such delays or required alterations to regulatory applications could also have a material adverse effect on our future revenue opportunities.

We have received FDA approval for the oral and intravenous formulations of TPOXX® in the U.S. for the treatment of smallpox,smallpox. We have not received FDA approval for the liquid suspension/pediatric formulation or any other formulation.formulation of TPOXX®. Because pharmaceutical manufacturers are only permitted to commercialize in the U.S. formulations that have received FDA approval (or in other jurisdictions according to their applicable regulatory and legal frameworks), any regulatory or legal setbacks as described above could have an adverse impact on the Company’sour ability to sell TPOXX® in other formulations.

Failure to maintain existing regulatory approvals or obtain future regulatory approvalapprovals in additional international jurisdictions could prevent us from marketing our products in certain jurisdictions abroad.

To market our products in certain additional foreign jurisdictions, we need to maintain existing regulatory approvals or may need to obtain separateadditional regulatory approvals and comply with numerous and varying regulatory requirements. The approval procedureprocedures variesvary among countries and can involve additional testing and differing manufacturing or labeling requirements. ComplyingComing into compliance with and maintaining compliance with such requirements may take substantial timetime, including prior to approvalapproval, and delay commercial activities in those jurisdictions.

The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval for expanded indications or new formulations of TPOXX®. We may be unable to maintain existing regulatory approvals or may not obtainbe successful in obtaining additional foreign regulatory approvals on a timely basis, if at all. Regulatory approval by the FDA, which we obtained for oral and IV TPOXX®, and by Health Canada, for oral TPOXX®, in each case for the treatment of smallpox, or by aadditional foreign regulatory authorityauthorities such as Health Canada, the European Medicines Agency,Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency, and the U.K. Medicines and Healthcare Products Regulatory Agency,Agency (MHRA), which we obtained for oral TPOXX® for the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against smallpox, does not ensure continued approval in those jurisdictions or approval by additional regulatory authorities in other foreign countries or jurisdictions or by the FDA for additional indications or new formulations. In addition, failure to obtain approval in one jurisdiction may impact our ability to obtain approvals elsewhere. We may not be able to file for or receive necessary regulatory approvals to commercialize our products in new markets, in which case, our addressable market may be reduced and our ability to realize the full potential of our products and product candidates may be harmed and our business, financial condition, results of operations and prospects may be adversely affected.

Products developed to treat diseases caused by or to combat the threat of bioterrorism or biowarfare are subject to changing political and social environments. The political and social responses to bioterrorism and biowarfare have been unpredictable and much debated. Changes in political leadership, such as the recentlatest change in the U.S. Presidential administration, as well as changes in the perception of the risk that military personnel or civilians could be exposed to biological agents as weapons of bioterrorism or biowarfare may delay or cause resistance to bringing investigational products to market or limit pricing or purchases of approved products, any of which could materially harm our business.

Lawsuits, protests or other negative publicity may adversely affect the degree of market acceptance of, and thereby limit the demand for, TPOXX® and any biodefense product candidates. In such event, our ability to market and sell such products may be hindered, the commercial success of TPOXX® and other products we develop may be harmed and we may need to expend time, attention and resources addressing such legal or publicity issues, thereby reducing our revenues and having a material adverse impact on us.our business.

Our ability to grow our business partly depends on our ability to achieve recurring sales of TPOXX® to customers other than the U.S. Government, which may exposeincrease usour exposure to risks associated with conducting business in international markets.

We recently reacquired international promotional rights and we may be unable successfully to expand our internal international sales and marketing capabilities or enter into agreements with third parties outside of the U.S..U.S.

Pursuant to the International Promotion Agreement described under “Business,” we previously granted a third party, Meridian Medical Technologies ("Meridian") exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in all geographic regions except for the United States (the “Territory”). In June 2024, we reacquired international promotional rights from Meridian. Our ability to maintain existing international customer relationships and contracts as well as generate future international relationships and contracts will depend on our ability to identify, hire and train qualified personnel. At present, we arecontinue atto adjust the earlystaffing stagesand key focal points of building out anthe international marketing organization.organization; as such, the build out of the international marketing organization is subject to additional refinements and adjustments.

For contracts with international customers that were originated by Meridian in prior years and remain active, thewe Company isare reliant on Meridian to collect payments from such customers, and to remit theto Company’sus our share of such payment to the Company.payments.

TheWe Company isare subject to complex and changing laws and regulations worldwide, which exposes the Companyus to potential liability, increased cost, and other adverse effects on the Company’sour business.

Some laws and regulations governing our business, including the U.S. Foreign Corrupt Practices Act (FCPA) and many other global anti-corruption laws, may hold us liable for the actions of our employees as well as those of our third-party partners. Although thewe Company hashave implemented policies and procedures designed to ensure compliance with applicable laws and regulations, there can be no assurance the Company’sour employees, contractors, third parties or agents will not violate such laws and regulations or the Company’sour policies and procedures.

Failure to comply with such laws and regulations could adversely affect the Company’sour business, reputation, financial condition, or ability to procure government contracts. Indeed, violations of the FCPA can result in significant civil and criminal penalties that can be levied on the Companyus and its executives. Indictment alone under the FCPA can lead to suspension of the right to do business with the U.S. Government until the pending claims are resolved and conviction under the FCPA can result in long-term disqualification as a government contractor. The SEC may also suspend or bar issuers from trading securities on U.S. stock exchanges for violations of the FCPA.

We have incurred in the past, and could incur net losses in the future, including if the remaining option is not exercised under the 19C BARDA Contract or we fail to enter into a new procurement contract with the U.S. Government.

While we believe our current cash position is strong, our ability to continue to fund future operations will be substantially impacted by remainingpotential cash flows from the 19C BARDA Contract or any new procurement contract with the U.S. Government. If BARDA fails to exercise the remaining option under the 19C BARDA Contract or we fail to enter into a new U.S. Government procurement contract or cash flows from such procurement contract are significantly delayed or significantly different from expectations, or if operating expenses or other expenses meaningfully exceed our expectations or cannot be adjusted accordingly, then our business, financial condition, results of operations and prospects could be materially adversely affected.

IfWe currently rely on third parties on whom we rely for manufacturing and raw materials of TPOXX®, and for managing our inventory,inventory. If these third parties do not perform as contractually required or as we expect, and we are unable to find an alternative third party to provide these services, we may not be able to successfully satisfy our obligations under any contracts, including the 19C BARDA Contract and any future U.S. Government procurement contract, and our business would suffer.

If a third-party provider fails to comply with applicable laws and regulations, fails to meet expected deadlines, fails to conduct trials in accordance with regulatory requirements or our stated protocols, experiences shortages or delays, or otherwise does not carry out its contractual duties to us, or encounters physical damage or natural disaster or disruptions at its facilities, our ability to meet our obligations under any contract including the 19C BARDA Contract or any future U.S. Government procurement contract, or to develop, obtain approval of and commercialization of other indications of TPOXX® or other drug candidates, could be significantly impaired or delayed. We do not currently have the internal capacity to perform these important functions, must contract with alternative third parties if our existing third-party providers are unable to fulfill their contractual duties, and we may not be able to maintain commercial arrangements for these services on reasonable terms.

Manufacturing API and finished drug products, especially in large quantities, is complex. Our products require several manufacturing steps at multiple facilities and involve complex techniques to assure quality and sufficient quantity. Our products must be made consistently and in compliance with a clearly defined manufacturing process. Accordingly, it is essential to be able to validate and control the manufacturing process to assure that it is reproducible. Slight deviations anywhere in the manufacturing process, including obtaining materials, filling, labeling, packaging, storage, shipping, quality control and testing, some of which all pharmaceutical companies, including SIGA,us, experience from time to time, may result in lot failures, delay in the release of lots, product recalls or spoilage. Success rates can vary dramatically at different stages of the manufacturing process, which can lower yields and increase costs. We may experience deviations in the manufacturing process that may take significant time and resources to resolve and, if unresolved, may affect manufacturing output and/or cause us to fail to satisfy contractual commitments, lead to delays in our clinical trials or result in litigation or regulatory action. Such actions would hinder our ability to meet contractual obligations and could cause material adverse consequences for our business.

We may not be able to fully commercialize the liquid suspension/pediatric formulation of TPOXX®, or other additional indications for TPOXX®, if our clinical trials do not demonstrate adequate safety or our animal studies do not demonstrate adequate efficacy.

The fact that the FDA has approved the oral and IV formulations of TPOXX® does not guarantee that our approach to drug development will be effective or will result in the successful commercialization of the liquid suspension/pediatric formulation of TPOXX®, any new indication such as post-exposure prophylaxis, of TPOXX® or any other drug.drug we seek to develop. We cannot predict with certainty whether any other drug candidate or expanded indication resulting from our research and development efforts will be approved by the FDA.

SIGA exclusively owns its key patent portfolios, which relate to its leading drug product, TPOXX® (also known as ST-246, tecovirimat). As of February 1,20, 2025,2026, the TPOXX® patent portfolio has seven patent families consisting of 2526 U.S. utility patents, 97101 issued foreign patents, one U.S. utility patent application, and 1412 foreign patent applications. With FDA regulatory approval of oral TPOXX® in July 2018, we were awarded seven years of regulatory exclusivity by the U.S. Patent and Trademark Office based on orphan drug designation for the product. Such protection is separate from, and in addition to, our patent and other intellectual property rights and provides for exclusivity to July 2025.

Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, we are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, phishing attacks, persons inside our organization or persons with access to systems inside our organization. The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased and been targeted at pharmaceutical companies in particular. Also,In addition, the increasing use of artificial intelligence technologies, including by our employees and third-party service providers, may increase thecybersecurity riskrisks, including risks related to data exposure, misuse of cyberconfidential attacks.or sensitive information, and the growing sophistication of AI-enabled cyber-attacks. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs.programs, manufacturing or quality systems, or other GxP-regulated activities. For example, the lossloss, corruption, or unavailability of clinical trial datadata, frommanufacturing completeddata, or ongoingquality records - whether maintained by us or plannedby clinicalthird trialsparties such as CROs or CDMOs - could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

In addition to being approved by the FDA, oral TPOXX® (tecovirimat) has received regulatory approval from the European Medicines Agency ("EMA"), Health Canada, the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom, and most recently, in December 2024, the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA"). The EMA, MHRA and PMDA approved oral TPOXX® for the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against smallpox. Health Canada approved TPOXX® for the treatment of smallpox.

In connection with a potential FDA label expansion of oral TPOXX® for an indication covering smallpox post-exposure prophylaxis (“PEP”), the Company has completed an immunogenicity trial and an expanded safety trial. The timing of a potential submission of a supplemental New Drug Application to the FDA (“Supplemental NDA”) for a smallpox PEP indication for oral TPOXX® will be based on the results of ongoing sample analyses from the immunogenicity trial; the Company is currently targeting a Supplemental NDA submission inwithin the next twelve months.

On September 10, 2018, the Company entered into a contract with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX® to the Strategic Stockpile, and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of IV TPOXX®. In October 2023, the contract was modified so that a course of IV TPOXX® was redefined within the contract from being 14 vials to being 28 vials; as such, the 19C BARDA Contract currently specifies 106,000 courses of IV TPOXX® (for the same payment amount as originally specified). In addition to the delivery of TPOXX® courses, the contract includes funding from BARDA for a range of activities, including: advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, development forof a pediatric formulation, support for manufacturing activities, and procurement activities. On April 8, 2025, total payments contemplated under the contract with BARDA were increased by $14.3 million to add funding for activities supporting manufacturing. On June 3, 2025, total payments contemplated under the contract with BARDA were increased by $13.2 million in connection with the development of the pediatric formulation of TPOXX®. As of December 31, 2024,2025, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $602.5$630 million of payments, of which approximately $51.7$79.2 million of payments are included within the base period of performance, approximately $519.6$545.2 million of payments are related to exercised options and up to approximately $31.2$5.6 million of payments are currently specified as unexercised options. BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term.

The options that have been exercised as of December 31, 2024,2025, provide for payments up to approximately $519.6$545.2 million. As of December 31, 2024,2025, there are exercised options for the following activities: payments up to $450.2 million for the manufacture and delivery of up to 1.5 million courses of oral TPOXX®; payments up to $51.2$76.8 million for the manufacture of courses of IV FDP, of which $20.5 million of payments relate to the manufacture of IV BDS to be used in the manufacture of IV FDP; payments of up to approximately $3.6 million to fund post-marketing activities for IV TPOXX®; and payments of up to $14.6 million for funding of post-marketing activities for oral TPOXX®. As of December 31, 2024,2025, a cumulative total of $396.9$450.2 million of oral TPOXX® has been delivered to the Strategic Stockpile and accepted, of which approximately $15 million was delivered in the first quarter of 2024, approximately $8 million was delivered in the third quarter of 2024, and approximately $51 million was delivered in the fourth quarter of 2024accepted; a cumulative total of $25.4$61.4 million of IV BDS or IV FDP has been either set aside in inventory or delivered to the Strategic Stockpile and accepted, of which approximately $17 million of revenueaccepted (includingIV recognitionBDS of deferred revenue) was recorded in the second quarter of 2024 and approximately $8 million of revenue (including recognition of deferred revenue) was recorded in the fourth quarter of 2024; $10.3 millionthat has been receivedset foraside thehas manufacture of IV BDS (such amount isbeen recorded as deferred revenue and will be recognized as revenue when the IV BDS is manufactured as IV FDP and delivered); and the Company has been cumulatively reimbursed $9.4$10.9 million in connection with post-marketing activities for oral and IV TPOXX®.

Unexercised options specify potential payments up to approximately $31.2$5.6 million in total (if all such options are exercised), all of which approximately $5.6 million relates to supportive activities that we currently do not expect to be required. The remaining unexercised options specify payments of up to $25.6 million for the manufacture of courses of IV FDP, of which up to $10.2 million of payments would be paid upon the manufacture of IV BDS to be used in the manufacture of IV FDP.

The options related to IV TPOXX® arewere divided into two primary manufacturing steps. There arewere options related to the manufacture of bulk drug substance (“IV BDS Options”), and there arewere corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”). BARDA mayhad the sole discretion to choose to exercise any, all, or none of these options in its sole discretion.options. The 19C BARDA Contract includesincluded: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 32,000 courses (as currently defined within the contract) of IV TPOXX®; and three separate IV FDP Options, each providing for 32,000 courses of final drug product of IV TPOXX®. BARDA hashad the sole discretion as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to exercise options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option). To date, BARDA has exercised two of theall three IV BDS options and two of theall three IV FDP options. If BARDA decides only to exercise the remaining IV BDS Option, then the Company would receive payments up to $10.2 million; alternatively, if BARDA decides to exercise the remaining IV BDS Option and IV FDP Option, then the Company would receive payments up to $25.6 million. BARDA may also decide not to exercise either remaining option. For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 32,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP. The Company estimates that sales of the IV formulation under this contract (under current terms), assuming the remaining IV FDP Option was exercised, would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%.

In 2024, the Company had sales of approximately $10 million with the U.S. Department of Defense ("DoD") (also known as the Department of War). Sales consistconsisted mostly of delivery of oral TPOXX®, with a minor amount of IV TPOXX® delivered.

Over the past threefour years, the Company has received three procurement contracts from the DoD, includingtotaling a $9$28 million contractin value, mostly in Augustconnection 2024,with whichthe hasmanufacture and delivery of oral TPOXX®. All deliveries specified under these contracts have been fulfilled.

In connection with the 2022 response to a global mpox outbreak, a series of observational and randomized, placebo-controlled clinical trials were initiated to assess the safety and efficacy of TPOXX® in participants with mpox. The purpose of these randomized clinical trials iswas to seek to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease. As of December 31, 2024,2025, twothree of the randomized, placebo-controlled clinical trials reported preliminary topline results: a randomized, placebo-controlled clinical trial in the Democratic Republic of the Congo ("DRC") known as PALM 007 (Tecovirimat for Treatment of Monkeypox Virus - NCT05559099), which iswas funded and sponsored by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID); and the Study of Tecovirimat for Human Mpox Virus (STOMP) clinical trial (NCT05534984), which iswas a randomized, placebo-controlled, double-blind study also sponsored and funded by NIAID to evaluate the safety and efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive mpox disease that included enrollees from Argentina, Brazil, Japan, Mexico, Peru, Thailand, and the United States.States; and the UNITY clinical trial (Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease - NCT NCT05597735), which was funded and sponsored by ANRS-Emerging Infectious Diseases, which included enrollees from Switzerland, Brazil, and Argentina. The PALM 007 study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the DRC with mpox who received TPOXX® compared to patients who received placebo. Some improvement versus placebo was observed in patients receiving TPOXX® whose symptoms began sevenfive days or fewer before randomization and patients with severe or grave disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions, however the significance of these data havehas not been established. AnSimilarly, interim analysis of data fromin the STOMP studystudy, showed that TPOXX®tecovirimat did not demonstratemeet efficacyits primary endpoint of a statistically significant improvement in time to skin and mucosal lesion resolution comparedfor to placebo in patientsadults with mild to moderate clade II mpox. Based on this resultmpox and additional analyses, the study Data Safety and Monitoring Board (DSMB) recommended to stop enrolling patients in the randomized arms of the study. NIAID accepted this recommendation and subsequently decided to take a similarlow action in the open label arm of this study, which included severe and at-riskrisk of developing severe diseasedisease. patients.Additional Dataanalyses analysisof is not yet complete for primary endpoint subgroups and detailedsubgroups, secondary and exploratory endpoints.endpoints is ongoing in each of these studies. Topline data from the UNITY study, which was presented at a medical conference, also showed that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution for patients with mpox who received TPOXX® compared to patients who received placebo. In bothall three studies, TPOXX® exhibited a safety profile comparable to placebo. These safety results are consistent with prior studies and further support the strong safety profile that has been observed with tecovirimat over the past 15 years.

ThreeTwo other randomized clinical trials, UNITY (Switzerland, Brazil, Argentina), Platinum-CAN (Canada), and EPOXI (EU), arewhich enrollingwere started in response to the global mpox patients.outbreak, Givenare theclosed STOMPto enrollment and PALM007expected resultsto andyield similar results, given the design similarities across these mpox trials, the Company believes these ongoing trials are likely to yield similar results.trials.

We account for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). The unit of account in ASC 606 is a performance obligation. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. Our performance obligations are satisfied over time as work progresses or at a point in time. Revenue connected with performance obligations related to product delivery and supportive services are recognized at a point in time. Revenue connected with performance obligations related to research and development and certain product supportive services are recognized over time.

Revenues from product sales and supportive services for the years ended December 31, 20242025 and 20232024 were $133.3$88.0 million and $130.7$133.3 million, respectively. Such revenues for the year ended December 31, 2025 include $53.3 million of oral TPOXX® sales and $25.8 million of IV TPOXX® sales to the U.S. Government under the 19C BARDA Contract; $5.8 million of oral TPOXX® sales to one international country and $3.1 million of supportive services. Such revenues for the year ended December 31, 2024 include $73.9 million of oral TPOXX® sales and $26.2 million of IV TPOXX® sales to the U.S. Government under the 19C BARDA Contract; $23.0 million related to international sales of oral TPOXX®; and approximately $10.1 million of oral TPOXX® sales to the DoD. Such revenues for the year ended December 31, 2023 include $97.9 million of oral TPOXX® sales to the U.S. Government under the 19C BARDA Contract; $21.3 million related to international sales of oral TPOXX®; and approximately $10.7 million of oral TPOXX® sales to the DoD.

Revenues from research and development activities for the years ended December 31, 20242025 and 2023,2024, were $5.4$6.5 million and $9.2$5.4 million, respectively. The revenues for the yearyears ended December 31, 2025 and 2024, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The revenue for the year ended December 31, 2023, were mostly earned in connection with performanceincrease of research and development activities under the PEP Label Expansion R&D Contract and the 19C BARDA Contract. The decrease of $3.8$1.1 million of revenue is primarily related to thean completionincrease ofin billablereimbursable activities under the PEP19C LabelBARDA Expansion R&D Contract in 2023.Contract.

Cost of sales and supportive services for the years ended December 31, 20242025 and 20232024 were $31.3$29.7 million and $17.8$31.3 million, respectively. Such costs in 2025 were primarily associated with the manufacture and delivery of courses of oral and IV TPOXX® to the U.S. Government under the 19C BARDA Contract. Such costs in 2024 were primarily associated with the manufacture and delivery of oral TPOXX® courses to the U.S. Government, DoD and various international customers as well as the manufacture and delivery of IV TPOXX® courses to the U.S. Government. Such costs in 2023 were associated with the manufacturing and delivery of oral TPOXX® to the U.S. Government as well as various international countries. The difference in costs between years is primarily due to the inclusion of IV TPOXX® in 2024 sales; manufacturing costs for IV TPOXX® are significantly higher than manufacturing costs for oral TPOXX®.

Research and development expenses were $12.3$20.0 million for the year ended December 31, 2024,2025, aan decreaseincrease of approximately $4.1$7.7 million from the $16.4$12.3 million incurred during the year ended December 31, 2023.2024. The decreaseexpense increase is primarily attributable to lower direct vendor-related expenses incurred in connection with a decrease in activities under the PEP Label Expansion R&D Contract, partially offset by an increase in self-funded research and development activity, as well as higher expenses for the implementation of information technology enhancements, higher compensation expense in connection with newan hires.increase in headcount, and an increase in the usage of regulatory and related consultants.

Other income, net for the years ended December 31, 20242025 and 20232024 was $6.1$6.7 million and $4.2$6.1 million, respectively. TheThese increaseamounts relates toreflect interest income earned on cash and cash equivalents as the average cash balance during the year ended December 31, 2024 was higher than in 2023. Additionally, the average investment return rates in the year ended December 31, 2024 were higher than those in 2023.equivalents.

We prepare our consolidated statement of cash flows using the indirect method. Under this method, we reconcile net income to cash flows from operating activities by adjusting net income for those items that impact net income but may not result in actual cash receipts or payments during the period. These reconciling items include but are not limited to stock-based compensation, deferred income taxes and changes in the fair value of our warrant liability; gains and losses from various transactions and changes in the consolidated balance sheet for working capital from the beginning to the end of the period.

Net cash provided by operations for the years ended December 31, 20242025 and 20232024 was $48.8$43.5 million and $94.8$48.8 million, respectively. For the year ended December 31, 2025, net cash increase from operations is due to the receipt of approximately $105 million from sales of oral and IV TPOXX® to the U.S. Government and international customers, of which approximately $85 million relates to 2025 sales and the remainder to collection of accounts receivable on the December 31, 2024 balance sheet, as well as the receipt of investment income on cash and cash equivalents, was partially offset by the payment of approximately $8 million of income taxes as well as for the use of cash (net of research development revenues) for inventory and customary operating activities. For the year ended December 31, 2024, net cash increase from operations iswas due to the receipt of approximately $122.5 million from sales of oral and IV TPOXX® to the U.S. Government and international customers, of which approximately $102 million relatesrelated to 2024 sales and the remainder to collection of accounts receivable on the December 31, 2023 balance sheet, partially offset by the payment of approximately $30 million of income taxes as well as the use of cash for customary operating activities. For the year ended December 31, 2023, the receipt of substantially all of the $45 million of accounts receivable as of December 31, 2022, the receipt of approximately $111 million of 2023 product sales of oral TPOXX®, as well as approximately $10 million received in connection with IV BDS deferred revenue was partially offset by the use of cash to proactively build inventory, and for operating activities.

We used $42,450$355,009 and $21,686$42,450 for capital expenditures for the years ended December 31, 20242025 and 2023,2024, respectively. Capital expenditures in 2025 were made in connection with the purchase of equipment related to future IV TPOXX® manufacturing.

Cash used in financing activities for the years ended December 31, 20242025 and 20232024 was $43.5$43.6 million and $43.4$43.5 million, respectively. For the year ended December 31, 2024,2025, we paid a special dividend of approximately $42.7$43.1 million asand well asspent approximately $0.8$0.4 million associated with the payment of tax obligations for employee common stock tendered. For the year ended December 31, 2023,2024, we paid a special dividend of approximately $32.1$42.7 million.million Inand addition, we purchasedspent approximately 1.7$0.8 million sharesassociated with the payment of tax obligations for employee common stock for approximately $11.0 million.tendered.

In addition to being approved by the FDA, oral TPOXX® (tecovirimat) has received regulatory approval from the European Medicines Agency ("EMA"), Health Canada, the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom, and the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA"). The EMA,EMA and MHRA have approved oral TPOXX® for the treatment of smallpox, cowpox, and PMDAvaccinia complications following vaccination against smallpox. PDMA has approved oral TPOXX® for the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against smallpox.smallpox, and Health Canada has approved oral TPOXX® for the treatment of smallpox.

On July 24, 2025, the EMA’s Committee for Medicinal Products for Human Use ("CHMP") closed its third annual reassessment for Tecovirimat-SIGA and initiated a referral procedure for the product following questions over its effectiveness in the treatment of mpox. These questions were raised following receipt of results from certain non-SIGA sponsored clinical trials evaluating tecovirimat as a potential mpox treatment including the PALM007 and STOMP clinical trials. In the referral procedure, CHMP reviewed all available data on the safety and efficacy of Tecovirimat-SIGA for all its authorized indications in order to make a recommendation to the European Commission whether the marketing authorization should be maintained, modified, suspended or withdrawn. On March 27, 2026, the CHMP issued its opinion following the conclusion of its review. CHMP confirmed the positive benefit-risk balance of Tecovirimat-SIGA as a treatment for smallpox, cowpox and vaccinia complications, and recommended, based on the results of the mpox clinical trials, that the product no longer be used for the treatment of mpox.mpox, and on May 29, 2026, the European Commission adopted the opinion of the CHMP. In April 2026, the MHRA requested SIGA align the Tecovirimat-SIGA label in the U.K. with the outcome of the referral procedure.

In connection with a potential FDA label expansion of oral TPOXX® for an indication covering smallpox post-exposure prophylaxis (“PEP”), the Company has completed an immunogenicity trial and an expanded safety trial. The timing of a potential submission of a supplemental New Drug Application to the FDA (“Supplemental NDA”) for a smallpox PEP indication for oral TPOXX® will be based on the results of ongoing sample analyses from the immunogenicity trial; the Company is currently targeting a Supplemental NDA submission withinin the nextfirst twelvehalf months.of 2027.

On September 10, 2018, the Company entered into a contract with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX® to the Strategic Stockpile, and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of IV TPOXX®. In October 2023, the contract was modified so that a course of IV TPOXX® was redefined within the contract from being 14 vials to being 28 vials; as such, the 19C BARDA Contract currently specifies 106,000 courses of IV TPOXX® (for the same payment amount as originally specified). In addition to the delivery of TPOXX® courses, the contract includes funding from BARDA for a range of activities, including: advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, development of a pediatric formulation, support for manufacturing activities, and procurement activities. On April 8, 2025, total payments contemplated under the contract with BARDA were increased by $14.3 million to add funding for activities supporting manufacturing. On June 3, 2025, total payments contemplated under the contract with BARDA were increased by $13.2 million in connection with the development of the pediatric formulation of TPOXX®. As of MarchJune 31,30, 2026, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $630 million of payments, of which approximately $79.2 million of payments are included within the base period of performance, approximately $545.2 million of payments are related to exercised options and up to approximately $5.6 million of payments are currently specified as unexercised options. BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term.

The base period of performance specifies potential payments of approximately $79.2 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 10,000 courses (as currently defined within the contract as being 28 vials) of final drug product of IV TPOXX® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $59.5 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities. As of MarchJune 31,30, 2026, the Company had received $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, $3.2 million for the manufacture of IV BDS, $4.8 million for the delivery of IV FDP to the Strategic Stockpile and $34.0$37.4 million for other base period activities. IV BDS has been used for the manufacture of courses of IV FDP. The $3.2 million received for the completed manufacture of IV BDS had been recorded as deferred revenue as of December 31, 2021, but with the delivery of IV FDP to the Strategic Stockpile during 2022, $2.9 million was recognized as revenue. The remaining $0.3 million of deferred revenue was recognized in the second quarter of 2024 as the IV FDP containing such IV BDS was delivered to and accepted by the Strategic Stockpile.

The options that have been exercised as of MarchJune 31,30, 2026, provide for payments up to approximately $545.2 million. As of MarchJune 31,30, 2026, there are exercised options for the following activities: payments up to $450.2 million for the manufacture and delivery of up to 1.5 million courses of oral TPOXX®; payments up to $76.8 million for the manufacture of courses of IV FDP; payments of up to approximately $3.6 million to fund post-marketing activities for IV TPOXX®; and payments of up to $14.6 million for funding of post-marketing activities for oral TPOXX®. As of MarchJune 31,30, 2026, a cumulative total of $450.2 million of oral TPOXX® has been delivered to the Strategic Stockpile and accepted; a cumulative total of $61.4$76.8 million of IV BDS or IV FDP has been either set aside in inventory or delivered to the Strategic Stockpile and accepted (IV BDS that hashad been set aside has beenand recorded as deferred revenue and will bewas recognized as revenue when the IV BDSFDP, is manufactured ascontaining IV FDPBDS, andwas delivered); and the Company has been cumulatively reimbursed $11.9$13.0 million in connection with post-marketing activities for oral and IV TPOXX®.

In the three and six months ended MarchJune 31,30, 2026, the Company didrecognized not$13.0 havemillion of international sales. In the threesix months ended MarchJune 31,30, 2025, the Company recognized $5.8 million of international sales consisting of a delivery of oral TPOXX® to one country. There was no revenue recognized in connection with international contracts during the three months ended June 30, 2025.

Under the terms of the current International Promotion Agreement, which was amended on March 27, 2024, and effective June 1, 2024, and further amended on August 30, 2024, the Company hashad primary responsibility for the advertising, promotion and sale of oral TPOXX® in all geographic regions. Meridian hashad limited, non-exclusive rights to advertise, promote, offer for sale and sell oral TPOXX® in the European Economic Area, Australia, Japan, Switzerland, the United Kingdom and the Association of Southeast Asian Nations and its member states (collectively, the “Current Territory”). Meridian also performsperformed non-promotional activities under specified contracts with third parties entered into prior to June 1, 2024, that provideprovided for the sale of oral TPOXX® in the Current Territory. The International Promotion Agreement entitlesentitled Meridian to receive a fee equal to a high single digit percentage of collected proceeds (whether collected by Meridian or the Company), net of certain expenses, of sales of oral TPOXX® in the Current Territory in the field of use specified in the International Promotion Agreement. The International Promotion Agreement hashad a fixed term that expiresexpired on May 31, 2026, with no automatic renewal.2026.

In connection with the 2022 response to a global mpox outbreak, a series of observational and randomized, placebo-controlled clinical trials were initiated to assess the safety and efficacy of TPOXX® in participants with mpox. The purpose of these randomized clinical trials was to seek to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease. As of MarchJune 31,30, 2026, three of the randomized, placebo-controlled clinical trials reported topline results: a randomized, placebo-controlled clinical trial in the Democratic Republic of the Congo ("DRC") known as PALM 007 (Tecovirimat for Treatment of Monkeypox Virus - NCT05559099), which was funded and sponsored by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID); the Study of Tecovirimat for Human Mpox Virus (STOMP) clinical trial (NCT05534984), which was a randomized, placebo-controlled, double-blind study also sponsored and funded by NIAID to evaluate the safety and efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive mpox disease that included enrollees from Argentina, Brazil, Japan, Mexico, Peru, Thailand, and the United States; and the UNITY clinical trial (Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease - NCT NCT05597735), which was funded and sponsored by ANRS-Emerging Infectious Diseases, which included enrollees from Switzerland, Brazil, and Argentina. The PALM 007 study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the DRC with mpox who received TPOXX® compared to patients who received placebo. Some improvement versus placebo was observed in patients receiving TPOXX® whose symptoms began five days or fewer before randomization and patients with severe or grave disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions, however the significance of these data has not been established. Similarly, in the STOMP study, tecovirimat did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution for adults with mild to moderate mpox and a low risk of developing severe disease. Additional analyses of subgroups, secondary and exploratory endpoints is ongoing in each of these studies. Topline data from the UNITY study, which was presented at a medical conference, also showed that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution for patients with mpox who received TPOXX® compared to patients who received placebo. In all three studies, TPOXX® exhibited a safety profile comparable to placebo. These safety results are consistent with prior studies and further support the strong safety profile that has been observed with tecovirimat over the past 15 years.

The U.S. tariffs implemented in 2025 and continuing in 2026, and subsequently implemented retaliatory tariffs, did not materially impact our firstsecond quarter or six months ended June 30, 2026 results. While the long-term effects remain uncertain, we continue to closely monitor the evolving tariff policy environment which presents a mix of impacts, with the potential for higher product and operating costs.

Three Months Ended MarchJune 31,30, 2026 and 2025

For the three months ended MarchJune 31,30, 2026, revenues from product sales and supportive services were $3.5$37.9 million. Such revenues include $1.2$24.4 million of IV TPOXX® sales to the U.S. Government under the 19C BARDA ContractContract, $13.0 million of sales to two international countries, as well as $2.3$0.5 million of reimbursed supportive services in connection with a manufacturing technology transfer. For the three months ended MarchJune 31,30, 2025, revenues from product sales and supportive services were $5.8$79.1 million. Such revenues include $5.8$53.3 million of oral TPOXX® and $25.8 million of IV TPOXX® sales to onethe internationalU.S. country.Government under the 19C BARDA contract.

Revenues from research and development activities for the three months ended MarchJune 31,30, 2026 and 2025, were $2.7$3.1 million and $1.2$2.0 million, respectively. The revenues for the three months ended MarchJune 31,30, 2026, were earned in connection with performance of research and development activities under the 19C BARDA Contract. The revenues for the three months ended MarchJune 31,30, 2025, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The increase of $1.5$1.1 million of revenue is primarily related to an increase in billable activities under the 19C BARDA Contract.

Cost of sales and supportive services for the three months ended MarchJune 31,30, 2026 and 2025 were $2.9$17.6 million and $0.2$25.6 million, respectively. Such costs in 2026 were primarily associated with the costs of supportive services in connection with a manufacturing technology transfer, as well as costs for the manufacture and delivery of courses of IV TPOXX® to the U.S. Government under the 19C BARDA Contract.Contract, costs for the manufacture and delivery of oral TPOXX® to international countries as well as the costs of supportive services in connection with a manufacturing technology transfer. Such costs in 2025 were associated with the manufacture and delivery of courses of oral and IV TPOXX® partiallyto offsetthe byU.S. aGovernment recoveryunder forthe inventory19C previouslyBARDA writtencontract, off.as well as the write off of $0.9 million of inventory.

Selling, general and administrative (“SG&A”) expenses for the three months ended MarchJune 31,30, 2026 and 2025 were $4.7$5.1 million and $5.7$5.5 million, respectively. The decrease of $1.0$0.4 million primarily reflects lower professionalcorporate serviceexpenses feesacross a range of functions and loweractivities, including consulting activities, professional services, and international business development expenses,activities, partially offset by higher compensation costs.

Other income, net for the three months ended MarchJune 31,30, 2026 and 2025 were $1.3$0.9 million and $1.7$1.6 million, respectively. These amounts reflect interest income earned on cash and cash equivalents.

For the three months ended MarchJune 31,30, 2026 and 2025, we recorded a pre-tax lossincome of ($4.0)$14.9 million and a pre-tax loss of ($0.6)$47.3 million, respectively, and a corresponding income tax benefitprovision of $0.6$2.4 million and $0.2$11.8 million, respectively. The effective tax rates during the three months ended MarchJune 31,30, 2026 and 2025 were 14.6%16.1% and 28.4%,24.9%, respectively. Our effective tax rates for the periods ended MarchJune 31,30, 2026 and 2025 differ from the statutory rate primarily as a result of currently forecasted losses for the full year, state taxes and non-deductible executive compensation under Internal Revenue Code Section 162(m). With respect to currently forecasted losses for the full year, such forecast is based on orders received to date and is subject to update upon the receipt of new procurement orders.

As of MarchJune 31,30, 2026, we had $145.6$117.6 million in cash and cash equivalents, compared with $155.0 million at December 31, 2025. We believe that our liquidity and capital resources will be sufficient to meet our anticipated requirements for at least the next twelve months from the issuance of these financial statements.

Net cash (used in)/provided by operating activities for the threesix months ended MarchJune 31,30, 2026 and 2025 was ($8.7)$6.5 million and $7.1$70.1 million, respectively. For the threesix months ended MarchJune 31,30, 2026, the net cash usedprovided inby operating activities primarily relates to the receipt of approximately $11 million from sales of IV TPOXX® from the U.S. Government, $13 million from the sales of oral TPOXX® to international countries, and $2 million from investment income, partially offset by the use of cash (net of research development revenues) for customary operating activities and inventory. For the threesix months ended MarchJune 31,30, 2025, the receipt of approximately $20$80 million from sales of TPOXX® to the U.S. Government and an international customer, all$20 million from sales of which wasTPOXX® from accounts receivable at December 31, 2024, as well as the receipt of investment income on cash and cash equivalents, was partially offset by the payment of approximately $8 million of income taxes as well as for the use of cash (net of research development revenues) for inventory and customary operating activities.

For the threesix months ended MarchJune 31,30, 2026, there were no cash-related investing activities; acquisitions of equipment thisduring quarterthe six months ended June 30, 2026 were not billed as of MarchJune 31,30, 2026. For the threesix months ended MarchJune 31,30, 2025, there was minimal (less than $25,000) cash-related investing activities.

Cash used in financing activities for the threesix months ended MarchJune 31,30, 2026 was $0.7$43.9 million, which was mostly attributable to the payment of a special cash dividend of approximately $43.3 million as well as the payments of tax obligations in connection with stock issued to employees as well as payments of accrued dividends on vested equity awards.employees. Cash used in financing activities for the threesix months ended MarchJune 31,30, 2025 was $0.2$43.1 million, which was mostly attributable to the payment of taxa obligationsspecial incash connectiondividend withof stockapproximately issued$42.9 to employees.million.

As of MarchJune 31,30, 2026, we had outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $3.5$1.3 million.

Forward-looking statements include statements regarding our future financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations and statements relating to the progress of SIGA’s development programs and timelines for bringing products to market, delivering products to domestic and international customers, and the enforceability of our procurement contracts, such as the 19C BARDA Contract (the "BARDA Contract"), with the U.S. Biomedical Advanced Research and Development Authority ("BARDA").contracts. The words “may,” “continue,” “estimate,” “intend,” “plan,” “will,” “believe,” “project,” “expect,” “seek,” “anticipate,” “could,” “should,” “target,” “goal,” “potential” and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that SIGA is not able to secure in a timely manner new contracts with the U.S. Government to substantially maintain or expand the U.S. Government stockpile of TPOXX®, (ii) the risk that SIGA may not complete performance under the 19C BARDA Contract (the "BARDA Contract"), with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") on schedule or in accordance with contractual terms, (ii) the risk that SIGA is not able to enter into new contracts to supply TPOXX® to the U.S. Government, (iii) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX® internationally, (iv) the risk that potential products, including potential alternative uses or formulations of TPOXX® that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (v) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (vi) the risk that SIGA or its collaborators will not obtain or maintain appropriate or necessary governmental approvals to market these or other potential products or uses, (vii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking, obtaining, or maintaining needed approvals to market these products, (x) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xi) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiii) the impacts of significant recent shifts in trade policies, including the imposition of tariffs, retaliatory tariff measures, and subsequent modifications or suspensions thereof, and market reactions to such policies and resulting trade disputes, (xiv) the risk of disruptions to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xv) risks associated with actions or uncertainties surrounding the debt ceiling, or the changes in the U.S. administration, and (xvi) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, are ineffective and may adversely affect SIGA’s business, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at http://www.sec.gov. All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events. The information contained on any website referenced in this Form 10-Q is not incorporated by reference into this filing.