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Item 1A. Risk Factors

2026-03-10 compared with 2025-03-11 · 103 added, 108 removed, 289 unchanged (42% of the section changed)

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Risks Related to Our Dependence on Government Contracts

We expect a substantial percentage of our future operating revenues to come from contracts with the U.S.

Government for the provision and maintenance of the stockpile of TPOXX® built under the 19C BARDA Contract.

Government does not enter into such a contract, or if such contract is materially delayed or smaller than the 19C BARDA Contract, our long-term business, financial condition and operating results could be materially harmed.

The success of our business and our operating results for the foreseeable future will be substantially dependent on the U.S.

Government’s commitment to maintaining or expanding its stockpile of TPOXX®.

Failure to secure in a timely manner and perform additional U.S.

Government contracts after the 19C BARDA Contract to substantially maintain or expand the U.S.

Government stockpile of TPOXX® could have a material adverse effect on our long-term business, financial condition, results of operations, including losses due to potential inventory write-offs, and prospects.

Additionally, the 19C BARDA Contract does not necessarily increase the likelihood that we will secure future comparable contracts with the U.S.

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 the 19C BARDA Contract, the Company's largest procurement contract, is tied to options all but one of which have been exercised and the remaining option may or may not be exercised at the sole discretion of BARDA.

Our inability to obtain a new procurement contract to supply TPOXX® to the U.S.

Government could cause our business, financial condition, results of operations and prospects to suffer materially.

The majority of potential revenue under any future U.S.

Government contract will likely be tied to options that may or may not be exercised at the sole discretion of the U.S.

Failure of the U.S.

Government to exercise 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 be materially harmed.

Government-funded contracts often consist of standalone procurement orders or a base period of performance followed by options for the performance of certain future activities.

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Our government customers are subject to political considerations and budgetary constraints, which result in uncertainties as to continued funding of their ongoing programs, including SIGA’s contracts.

As of December 31, 2024, 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 potential revenues under such contract will be favorable.

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 on favorable terms, 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, our business, financial condition, results of operations and prospects may suffer materially.

As of December 31, 2025, all of the options to which most of the contract value of the 19C BARDA Contract is tied have been exercised.

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 U.S.

Government will exercise its options under such new procurement agreement.

Government fails to exercise its options under such new procurement agreement, if any, our business, financial condition, results of operations and prospects may suffer materially.

Government procurement contracts are mostly set at fixed prices determined at inception of the contract based on estimates of the time, resources and expenses required to perform these contracts.

If our estimates are not accurate, we may not be able to earn an adequate return or may incur a loss under these arrangements.

Remaining unexercised options under current government procurement contracts, including the 19C BARDA Contract, are predominately fixed-price.

We expect that our future contracts with the U.S.

Previously exercised options under our government procurement contracts, including the 19C BARDA Contract, were predominately fixed price.

We expect that any 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.

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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.

We expect a substantial percentage of our future operating revenues to come from contracts with the U.S.

Government for the provision and maintenance of the stockpile of TPOXX® built under the 19C BARDA Contract.

Government does not enter into such a contract, our long-term business, financial condition and operating results could be materially harmed.

The success of our business and our operating results for the foreseeable future will be substantially dependent on the U.S.

Government’s commitment to maintaining or expanding its stockpile of TPOXX®.

Failure to secure and perform additional U.S.

Government contracts after the 19C BARDA Contract to substantially maintain or expand the U.S.

Government stockpile of TPOXX® could have a material adverse effect on our long-term business, financial condition, results of operations and prospects.

Additionally, the 19C BARDA Contract does not necessarily increase the likelihood that we will secure future comparable contracts with the U.S.

Laws and regulations affecting government contracts and grants might make it more costly and difficult for us to successfully conduct our business.

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Our government contracts and grants could be terminated under these circumstances.

Government shutdown could negatively impact our business and liquidity.

Government shutdown could materially adversely affect our business, results of operations, and financial condition.

Each year, the U.S.

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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.

A significant portion of our revenue is derived from contracts with U.S.

federal agencies.

continues to face a changing geopolitical environment, along with certain fiscal and economic challenges, and uncertainty exists regarding how future budget and program decisions will unfold.

During periods of federal government shutdowns, many government agencies and contracting offices cease operations or operate at reduced capacity.

These shutdowns may delay funding decisions, new contract awards, contract modifications, and may result in the suspension of ongoing work under existing contracts.

In the event of a prolonged shutdown, we may experience delays in securing new procurement contracts, which could result in reduced revenue.

Even after government operations resume, it may take additional time for normal contracting activities to resume.

Government shutdowns can also create uncertainty in federal budgeting and procurement priorities, which could reduce future opportunities for our products.

The timing and duration of any shutdown are unpredictable, and we cannot estimate the ultimate effect on our business.

Any prolonged or repeated shutdowns could have a material adverse effect on our financial condition, results of operations, and ability to execute our strategic objectives.

Our business could be adversely affected by a negative audit by the U.S.

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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.

Such actions would also negatively affect our reputation.

Such actions could materially damage our business and could also negatively affect our reputation.

Risks Related to Regulatory Approvals

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Government, and our ability to generate future revenue could be materially impaired.

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.

The development and commercialization of additional indications for TPOXX® in the U.S., such as use for smallpox post-exposure prophylaxis ("PEP"), 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.

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Because samples from that trial are being reanalyzed by the U.S.

Centers for Disease Control and Prevention, the Company is now targeting a supplemental NDA submission in 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 mpox indication or may prevent us from getting procurement orders from the U.S.

Centers for Disease Control and Prevention which has been impacted by recent U.S.

Government shutdowns, the Company is now targeting a supplemental NDA submission within the next twelve months.

Failure to obtain regulatory approval of the PEP indication 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.

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We have received FDA approval for the oral and intravenous formulations of TPOXX® in the U.S.

for the treatment of smallpox, not the liquid suspension/pediatric formulation or any other formulation.

Because pharmaceutical manufacturers are only permitted to commercialize 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’s ability to sell TPOXX® in other formulations.

Failure to obtain future regulatory approval 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 may need to obtain separate regulatory approvals and comply with numerous and varying regulatory requirements.

The approval procedure varies among countries and can involve additional testing and differing manufacturing or labeling requirements.

Complying with such requirements may take substantial time prior to approval and delay commercial activities in those jurisdictions.

for the treatment of smallpox.

We have not received FDA approval for the liquid suspension/pediatric formulation or any other 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 our ability to sell TPOXX® in other formulations.

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

To market our products in certain foreign jurisdictions, we need to maintain existing regulatory approvals or may need to obtain additional regulatory approvals and comply with numerous and varying regulatory requirements.

The approval procedures vary among countries and can involve additional testing and differing manufacturing or labeling requirements.

Coming into compliance with and maintaining compliance with such requirements may take substantial time, including prior to approval, 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 not obtain additional foreign regulatory approvals on a timely basis, if at all.

Regulatory approval by the FDA, which we obtained for oral and IV TPOXX®, or by a foreign regulatory authority such as Health Canada, the European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency, and the Medicines and Healthcare Products Regulatory Agency, which we obtained for oral TPOXX®, does not ensure 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.

We may be unable to maintain existing regulatory approvals or may not be 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 additional foreign regulatory authorities such as European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency, and the U.K.

Medicines and Healthcare Products Regulatory 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.

The EMA and MHRA approved TPOXX® under “exceptional circumstances” under the brand name Tecovirimat-SIGA.

These regulators granted marketing authorizations under “exceptional circumstances” because it was not possible to obtain complete efficacy and safety information about the product due to the rarity of smallpox and other orthopoxviruses and because ethical considerations prevented conducting the necessary clinical studies.

The Tecovirimat-SIGA marketing authorizations under “exceptional circumstances” are subject to certain specific obligations to gather additional data post-approval to help confirm the product’s safety and efficacy.

All “exceptional circumstances” marketing authorizations are subject to annual reassessments that consider whether data generated pursuant to the specific obligations continue to confirm its positive benefit-risk profile.

These annual reassessments determine whether the product’s marketing authorization should be maintained, changed, suspended, or withdrawn based on its benefit-risk profile.

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.

The CHMP is expected to meet in March to issue its recommendation.

We expect the CHMP will confirm the positive benefit-risk balance of Tecovirimat-SIGA as a treatment for smallpox, cowpox, and vaccinia complications, and maintain those indications in the product label.

Regarding mpox, based on the results of the mpox clinical trials, we expect the CHMP will recommend withdrawal of the mpox indication.

In the UK, Tecovirimat-SIGA is undergoing an annual reassessment by the MHRA.

This reassessment, which is ongoing, is substantially similar to the EMA’s annual reassessment process and could result in a similar outcome.

If the CHMP recommends withdrawal of the mpox indication, and European Commission adopts the recommendation of the CHMP, it could negatively impact our anticipated revenue from Tecovirimat-SIGA and could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

In addition, failure to obtain or maintain approval in one jurisdiction may impact our ability to obtain approvals elsewhere.

We may not be able to maintain existing approvals or may be unable 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.

Risks Related to Commercial and International Activities

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The political and social responses to bioterrorism and biowarfare have been unpredictable and much debated.

Changes in political leadership, such as the recent change in the U.S.

Changes in political leadership, such as the latest 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 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 expose us to risks associated with conducting business in international markets.

Government, which may increase our exposure to risks associated with conducting business in international markets.

An element of our business strategy is to sell TPOXX® internationally to foreign governments on a recurring basis.

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regional safety and security considerations;

increased costs and risks relating to exportation, shipping and transportation of the Company’s products, including the impact of any trade disputes or other trade barriers, such as the imposition of new or increased tariffs;

increased costs and risks and uncertainties relating to exportation, shipping and transportation of our products, including the impact of any trade disputes or other trade barriers, such as the imposition and enforceability of new or increased tariffs, any retaliatory actions taken by counties impacted by such tariffs and uncertainties regarding the ability to obtain refunds for previously paid tariffs that have subsequently been invalidated;

increased management and infrastructure costs.

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We cannot predict the ultimate impact such events might have on the Company’s business, financial condition and results of operations.

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..

We 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.

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”).

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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 are at the early stages of building out an international marketing organization.

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

At present, we continue to adjust the staffing and key focal points of the international marketing 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, we are reliant on Meridian to collect payments from such customers, and to remit to us our share of such payments.

Under the terms of the Amended International Promotion Agreement, Meridian remains responsible for collecting payments from customers under certain legacy contracts and remitting such payments to us on a quarterly basis.

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Any of the foregoing could adversely impact our business, financial condition and operating results as a result.

If we are unable to expand our internal sales and marketing capabilities or enter into agreements with third parties with expertise in sales and marketing, we may be unable to expand our sales of TPOXX® or other product candidates in the U.S., including to U.S.

customers other than the U.S.

In the United States, we currently employ a small, targeted group to support development and business activities related to TPOXX®.

We plan to continue our current approach for sales to the U.S.

Government of any other biodefense product candidates that we may successfully develop.

This approach may prove insufficient to adequately support our development and business activities in the United States.

In order to expand our sales of TPOXX® or other product candidates in the U.S., including to U.S.

customers other than the U.S.

Government, we may need to enhance our own sales and marketing capabilities, and/or enter into collaborations with third parties able to perform these services or outsource these functions to third parties.

There is no assurance that we will be able to do so successfully, and even if we are able to do so that it will have a significant impact on our growth or profitability.

Although TPOXX® is currently stockpiled by certain governments and not sold commercially, in the future we may be required to perform additional clinical trials or change the labeling of TPOXX® if we or others identify side effects after a product is on the market, which could harm future sales of such product.

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reformulation of our products, additional clinical trials or other testing or changes in labeling of our products may be required;

changes to or re-approvals of manufacturing facilities used by SIGA may be required;

changes to or re-approvals of manufacturing facilities we use may be required;

sales of the affected products may drop significantly;

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Any of the above occurrences could harm or prevent future sales of the affected product or could increase the costs and expenses of commercializing and marketing these products, which could adversely affect our business, financial condition and results of operations.

If we sell TPOXX ® to non-government customers and are able to charge such customers higher prices than we charge to the U.S.

Government , healthcare reform and controls on healthcare spending in the U.S.

may nonetheless limit the prices we charge for our products and the amounts that we can sell.

There have been a number of legislative and regulatory proposals in the United States to change the health care system in ways that could affect our pricing of TPOXX® to non-government customers.

One significant example of recent legislative action is the Inflation Reduction Act of 2022 (the “IRA”), which was signed into law on August 16, 2022.

The IRA, as written, among other changes, gives HHS the ability and authority to directly negotiate with manufacturers the price that Medicare will pay for certain high-priced drugs.

The IRA also requires manufacturers of certain Part B and Part D drugs to issue to HHS rebates based on certain calculations and triggers (i.e., when drug prices increase and outpace the rate of inflation).

Implementation of the IRA's drug price negotiation provisions began in 2023, and is expected to continue over the next several years.

Multiple pharmaceutical manufacturers have challenged the law in court, largely on constitutional grounds.

These suits will continue through 2025 and the ultimate effects of such legal challenges are unclear.

In addition, there are uncertainties as to the extent to which the IRA and similar frameworks will be implemented under the new U.S.

administration.

At this time, we continue to evaluate the effect of the IRA on our business operations and financial condition and results as the full impact of the IRA remains uncertain.

In addition, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “Healthcare Reform Act”), substantially changed the way healthcare is financed by both governmental and private insurers and had a substantial effect on the pharmaceutical industry.

The Healthcare Reform Act contains a number of provisions, including those governing enrollment in federal healthcare programs like Medicare, reimbursement changes and rules protecting against fraud and abuse, that affect existing healthcare programs.

If we are able to charge higher prices to non-government customers than we charge to the U.S.

Government, healthcare reform and controls on healthcare spending in the U.S.

may nonetheless limit the price we charge for our products and the amounts that we can sell.

For example, some of our revenue may be derived from governmental healthcare programs, including Medicare.

Furthermore, beginning in 2011, the Healthcare Reform Act imposed a non-deductible excise tax on pharmaceutical manufacturers or importers who sell “branded prescription drugs,” which includes innovator drugs and biologics (excluding orphan drugs or generics) to U.S.

Government programs.

The Healthcare Reform Act and other healthcare reform measures that may be adopted in the future could have an adverse effect on our industry generally, as well as potential future sales and profitability of our current or future products.

Additionally, the new U.S.

administration may propose or mandate policy changes that create additional uncertainty for our business.

The Company is subject to complex and changing laws and regulations worldwide, which exposes the Company to potential liability, increased cost, and other adverse effects on the Company ’ s 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 the Company has implemented policies and procedures designed to ensure compliance with applicable laws and regulations, there can be no assurance the Company’s employees, contractors, third parties or agents will not violate such laws and regulations or the Company’s policies and procedures.

Failure to comply with such laws and regulations could adversely affect the Company’s 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 Company and its executives.

We are subject to complex and changing laws and regulations worldwide, which exposes us to potential liability, increased cost, and other adverse effects on our business.

Some laws and regulations governing our business, including the 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 we have implemented policies and procedures designed to ensure compliance with applicable laws and regulations, there can be no assurance our employees, contractors, third parties or agents will not violate such laws and regulations or our policies and procedures.

Failure to comply with such laws and regulations could adversely affect our 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 us and its executives.

Indictment alone under the FCPA can lead to suspension of the right to do business with the U.S.

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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.

While we believe our current cash position is strong, our ability to continue to fund future operations will be substantially impacted by remaining cash flows from the 19C BARDA Contract or any new procurement contract with the U.S.

If BARDA fails to exercise the remaining option under the 19C BARDA Contract or we fail to enter into a new U.S.

We have incurred in the past, and could incur net losses in the future, including if we fail to enter into a new procurement contract with the U.S.

While we believe our current cash position is strong, our ability to continue to fund future operations will be substantially impacted by potential cash flows from any new procurement contract with the U.S.

If 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.

Risks Related to Manufacturing, Storage and Our Dependence on Third Parties

If third parties on whom we rely for manufacturing and raw materials of TPOXX®, and managing our inventory, do not perform as contractually required or as we expect, we may not be able to successfully satisfy our obligations under any contracts, including the 19C BARDA Contract and any future U.S.

We currently rely on third parties for manufacturing and raw materials of TPOXX® and for managing our 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.

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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, and we may not be able to maintain commercial arrangements for these services on reasonable terms.

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 may not be able to maintain commercial arrangements for these services on reasonable terms.

In addition, the facilities used by our third-party manufacturers must be approved by the FDA and comparable foreign regulatory authorities.

If our third-party manufacturers including any we contract with in the future, cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure or maintain regulatory approval for their manufacturing facilities.

If the FDA or a comparable foreign regulatory authority does not approve the facility of a third-party manufacturer for the manufacture of TPOXX®, or if it withdraws any such approval in the future, it may significantly impact our ability to commercialize TPOXX®.

For example, Patheon, the manufacturer for IV TPOXX®, notified us that it will be closing the manufacturing line on which it manufactures IV TPOXX® in 2026.

We have contracted with an alternative third-party manufacturer and are in the process of transferring the manufacturing process for IV TPOXX® to such third party.

This manufacturing process is complex, and it may take significant time and resources to complete the transfer.

In addition, upon completion, the third-party’s manufacturing facility will need to obtain FDA approval for the manufacture of IV TPOXX®.

Failure to timely complete the transfer of the manufacturing process or to obtain FDA approval for the third-party manufacturing facility could hinder our ability to meet contractual obligations for IV TPOXX® and could cause material adverse consequences for our business.

If third parties on whom we rely for packaging and delivery of our products, are unable to meet the target timing for deliveries to our customers, product revenue recognition may be delayed and our business could suffer.

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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, experience from time to time, may result in lot failures, delay in the release of lots, product recalls or spoilage.

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 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.

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If we are not successful in completing the development and commercialization of our drug candidates, whether due to our efforts or due to concerns raised by our governmental regulators or customers, our business could be materially adversely affected.

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.

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

Before obtaining regulatory approval for the sale of our drug candidates, extensive development is required.

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Liquid Suspension/Pediatric TPOXX® formulations are currently in product development and there can be no assurance of successful development or ultimate commercialization.

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.

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.

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utility patent application, and 12 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.

We also rely on trade secrets, know-how, continuing technological innovation and licensing opportunities.

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Risks Related to Our Common Stock

Concentration of ownership of our capital stock could delay or prevent a change of control.

Our directors, executive officers and beneficial owners of more than 5% of our common stock ("principal stockholders") beneficially own a significant percentage of our common stock.

As a result, these stockholders, if acting together, have the ability to influence the outcome of corporate actions requiring stockholder approval.

Additionally, this concentration of ownership may have the effect of delaying or preventing a change of control of SIGA.

As of February 14, 2025, directors, executive officers and principal stockholders (excluding institutional and retail investors) beneficially owned approximately 35% of our outstanding common stock.

In addition to owning common stock of the Company, directors and certain executive officers have the right to acquire additional stock through the exercise or conversion of certain securities.

Affiliates of MacAndrews & Forbes Incorporated (together with its affiliates “ MacAndrews ” ) have substantial ownership of SIGA stock and their interests may differ from the interests of other stockholders.

MacAndrews holds, directly or indirectly, approximately 34% of outstanding shares of SIGA stock.

Due to MacAndrews’ substantial ownership percentage and the rights under the securities purchase agreement (the "Securities Purchase Agreement") that was signed in 2003 between SIGA and an affiliate of MacAndrews, MacAndrews has a level of influence over us and our subsidiaries that other investors do not have.

The concentration of ownership and voting power of MacAndrews will limit other stockholders’ ability to influence corporate matters and may also delay, defer or even prevent an acquisition by a third party or other change of control of our company and may make some transactions more difficult or impossible without the support of MacAndrews.

Also, the concentration of voting power with MacAndrews could result in actions by the Company with which other stockholders do not agree.

A future issuance of preferred stock may adversely affect the rights of the holders of our common stock.

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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, increasing use of artificial intelligence may increase the risk of 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.

For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

In addition, the increasing use of artificial intelligence technologies, including by our employees and third-party service providers, may increase cybersecurity risks, including risks related to data exposure, misuse of confidential 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, manufacturing or quality systems, or other GxP-regulated activities.

For example, the loss, corruption, or unavailability of clinical trial data, manufacturing data, or quality records - whether maintained by us or by third parties such as CROs or CDMOs - could result in delays in regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

Also, our processing of sensitive information may subject us to data privacy and security obligations, and confidential patient and other personal or sensitive information may be compromised in a cyber-attack or cyber-intrusion.

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What changed 10-K

Item 1A. Risk Factors