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Fri Oct 23 · pre-market6 signals on Oct 22103 insider buys this week · $208.8MCIRO short report next: Oct 31The week ahead

ARMP

Armata Pharmaceuticals, Inc.
NYSE · HEALTH CARE · BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
3.45
+0.39 +12.75%
USD · close Oct 22

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How ARMP rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
79%
of sentences unchanged
Added
41
new sentences
Dropped
45
sentences removed
Length
+130
words, now 14,779

New in FY2025

  • Our consolidated financial statements as of December 31, 2025 and December 31, 2024 were prepared under the assumption that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
  • As of December 31, 2025, we had unrestricted cash and cash equivalents of $8.7 million, and we have had recurring losses from operations and negative operating cash flows since inception.
  • Our outstanding term loans, which comprise of $85.0 million of principal and $18.1 million of accrued interest, mature in June 2027 and January 2029. ​ We will need to raise additional capital to support our operations and product development activities.
  • Any of these events could have a material adverse effect on our business, financial condition and results of operations. ​ While we believe that our existing resources will be sufficient to fund our planned operations into fiscal year 2026, we cannot provide assurances that our estimates will be accurate, that our plans will not change or that changed circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate.
  • Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations. ​ As of December 31, 2025, our accumulated deficit was $501.5 million and we expect to incur losses for the foreseeable future.
  • This award has been used to partially fund the Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled dose escalation study to assess the safety, tolerability and efficacy of our phage-based candidate, AP-SA02, for the treatment of adults with S. aureus (the “diSArm” study) and to support activities required for the EOP2 meeting with the FDA .
  • On July 29, 2024, the MTEC Agreement was modified to increase the total award by $5.3 million to $21.6 million and extend the term into the third quarter of 2025.
  • On April 29, 2025, we received $4.65 million of additional non-dilutive award funding through MTEC, thereby increasing the total MTEC award to $26.2 million, and the MTEC Agreement was modified to extend the term to September 30, 2025.
  • On July 2, 2025, the MTEC Agreement was modified to extend the term to March 31, 2026. ​ Government contracts and grants normally contain additional requirements that may increase our costs of doing business and expose us to liability for failure to comply with these terms and conditions.
  • If we experience significant delays in the progress of our clinical trials and in our plans to submit BLA, the commercial prospects for product candidates could be harmed and our ability to generate product revenue would be delayed or prevented.
  • In addition, if we receive sensitive personal information, including health information, we may be subject to state laws governing the use, security, and disclosure of such information.
  • We cannot assure you that we, our CROs, our clinical trial sites, and our clinical trial principal investigators with access to personal information and other sensitive or confidential information relating to the patients in our clinical trials will not breach contractual obligations, or that we or they will not experience data security breaches or attempts thereof.
  • The regulatory framework for the collection, use, safeguarding, sharing, transfer, and other processing of personal information worldwide is rapidly evolving and is likely to remain uncertain for the foreseeable future.
  • For example, the California Consumer Privacy Act (the “CCPA”), which went into effect on January 1, 2020, provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. ​ Additionally, the CCPA was amended by the California Privacy Rights Act, which significantly amends the CCPA and imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data.
  • It also created a new California data protection agency authorized to issue substantive regulations, which could result in increased privacy and information security enforcement.
  • The majority of the amendments went into effect on January 1, 2023, and additional compliance investment and potential business process changes may be required.
  • Similar so-called comprehensive privacy laws have been enacted in, or are being considered by, other states.
  • In addition, a broad range of privacy-related legislative measures also have been introduced at the federal level, though none has yet been enacted.
  • The enactment of new or amended privacy laws in other states or at the federal level could result in potentially conflicting requirements, which would make compliance challenging and costly. ​ The FTC and many state attorneys general continue to enforce federal and state consumer protection laws against companies for online collection, use, dissemination and security practices that appear to be unfair or deceptive.
  • The collection, use, disclosure, transfer, or other processing of personal data regarding individuals in the European Economic Area (“EEA”), including personal health data, is subject to the General Data Protection Regulation, (EU) 2016/679 (the “EU GDPR”).
  • The EU GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors.
  • The EU GDPR broadly defines personal data to include data which identities, directly or indirectly, a natural person, including coded data and requiring changes to informed consent practices and more detailed notices for clinical trial patients and investigators.
  • In addition, the EU GDPR imposes strict rules on the transfer of personal data to countries outside the EEA, including the United States and, as a result, increases the scrutiny that clinical trial sites located in the EEA should apply to transfers of personal data from such sites to countries that are considered to lack an adequate level of data protection, such as the United States.
  • The EU GDPR also permits data protection authorities to require destruction of improperly gathered or used personal data or impose substantial fines for violations of the EU GDPR, which can be up to 4% of global revenues or €20 million, whichever is greater, and it also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the EU GDPR.
  • In addition, the EU GDPR provides that EU member states may enact additional laws and regulations further limiting the processing of personal data, including genetic, biometric, or health data. ​ Furthermore, since the United Kingdom is no longer part of the EU, its data protection regulatory regime is independent of the EU.
  • From January 1, 2021, companies have had to comply with both the EU GDPR and the United Kingdom GDPR, which, together with the amended United Kingdom Data Protection Act 2018, assimilates the GDPR in UK national law (collectively, the “UK GDPR”).
  • While the differences between the EU GDPR and UK GDPR to date are largely administrative, the substantive requirements of the laws may diverge over time as regulators and courts impose differing interpretations on otherwise similar provisions.
  • The speed at which AI technologies are being adopted, and the uncertainty regarding the scope and details of laws, regulations or standards governing their use, combined with the growing interest of various legislatures and regulators to address the development and deployment of AI technologies in a manner which may not be consistent across jurisdictions, increases these risks.
  • In addition, it can be very difficult to predict revenue growth rates of, or variability in demand for, new products and indications, which in some cases leads to difficult meeting product demand or, on the other hand, excess inventory and related financial charges. ​ We face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than we do.
  • In addition, Innoviva’s interests in our business may be different than our other stockholder s. ​ As of December 31, 2025, Innoviva owns 68.8% of our outstanding shares and 10,653,847 warrants to purchase shares of our Common Stock.
  • If Innoviva were to exercise the warrants held by them, they would hold approximately 75.9% of our issued and outstanding shares of Common Stock.
  • Between January 1, 2025 and December 31, 2025, the high and low sales prices of our Common Stock as reported on NYSE varied between $0.90 and $16.34 per share.
  • The stock market in general and the market for biotechnology and biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the companies’ operating performance, in particular during the last several years. ​ As of December 31, 2025, we had outstanding common warrants to purchase an aggregate of 10,655,047 shares of our Common Stock at a weighted-average exercise price of $4.18 per share.
  • We also have outstanding options to exercise 4,803,921 shares of our Common Stock at a weighted-average exercise price of $3.22 per share.
  • To the extent any of our outstanding warrants or options are exercised, additional shares of our Common Stock will be issued which will result in dilution to our security holders and could also have an adverse effect on the market price of our Common Stock. ​ Raising additional capital may cause dilution to our stockholders, restrict our operations, and/or require us to relinquish rights to our technologies or product candidates .
  • Our operations could be disrupted if our information systems—or those of our vendors— fail, if communications or other critical infrastructure fail, if we or our vendors are unsuccessful in implementing necessary upgrades, or if we or our vendors are subject to successful cyber-attacks.
  • Despite our efforts to monitor and safeguard our systems to prevent data compromise (as discussed below in Item 1C), such attacks are increasing in frequency and sophistication, including as a result of threat actors’ use of artificial intelligence, and the possibility of a future data compromise, and risks associated with intrusion, tampering, and theft, cannot be eliminated entirely.
  • We have experienced cyber-attacks in various forms, including phishing and other attempts to compromise our systems, but none of these incidents have resulted in a material adverse impact on our business operations, financial condition, or reputation.
  • To the extent that any disruption or security breach were to result in a loss of or damage to data or applications, or inappropriate disclosure of confidential or proprietary information or personal health information, we could incur substantial liability, our reputation may be damaged and the further development of our product candidates could be delayed.
  • The Company’s and its vendors’ information technology operations are spread across multiple, sometimes inconsistent, platforms, which can pose operational difficulties, such as in maintaining data integrity across systems.

and 1 more.

Gone since FY2024

  • We will need substantial additional financing to develop our product candidates and implement our operating plans, including to support one or more pivotal trials in 2025 and beyond.
  • Our consolidated financial statements as of December 31, 2024 and December 31, 2023 were prepared under the assumption that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
  • As of December 31, 2024, we had unrestricted cash and cash equivalents of $9.3 million, and we have had recurring losses from operations and negative operating cash flows since inception.
  • In March 2024, we received an additional loan from Innoviva of $35.0 million.
  • Our outstanding term loans, which comprise of $60.0 million of principal and $9.4 million of accrued interest, mature in January 2026 and in June 2025. ​ We will need to raise additional capital to support our operations and product development activities.
  • Any of these events could have a material adverse effect on our business, financial condition and results of operations. ​ While we believe that our existing resources will be sufficient to fund our planned operations into fiscal year 2025, we cannot provide assurances that our estimates will be accurate, that our plans will not change or that changed circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate.
  • Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations. ​ As of December 31, 2024, our accumulated deficit was $327.7 million and we expect to incur losses for the foreseeable future.
  • In July 2024, the MTEC Agreement was modified to increase the total award by $5.3 million to $21.6 million and extend the term into the third quarter of 2025.
  • We are using the award to partially fund a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled dose escalation study that will assess the safety, tolerability and efficacy of our phage-based candidate, AP-SA02, for the treatment of adults with S. aureus (“diSArm” study) . ​ Government contracts and grants normally contain additional requirements that may increase our costs of doing business and expose us to liability for failure to comply with these terms and conditions.
  • If we experience significant delays in the progress of our clinical trials and in our plans to submit Biologics License Applications, the commercial prospects for product candidates could be harmed and our ability to generate product revenue would be delayed or prevented.
  • In addition, if we receive sensitive personally identifiable information, including health information, we may be subject to state laws governing the use, security, and disclosure of such information.
  • We cannot assure you that we, our CROs, our clinical trial sites, and our clinical trial principal investigators with access to personally identifiable and other sensitive or confidential information relating to the patients in our clinical trials will not breach contractual obligations, or that we or they will not experience data security breaches or attempts thereof.
  • The regulatory framework for the collection, use, safeguarding, sharing, transfer, and other processing of information worldwide is rapidly evolving and is likely to remain uncertain for the foreseeable future.
  • For example, the California Consumer Privacy Act (the “CCPA”), which went into effect on January 1, 2020, provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation.
  • Many other states are considering similar legislation.
  • A broad range of legislative measures also have been introduced at the federal level.
  • There also is the threat of consumer class actions related to these laws and the overall protection of personal data. ​ Additionally, the CCPA was amended by the California Privacy Rights Act, which significantly amends the CCPA and imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data.
  • It will also create a new California data protection agency authorized to issue substantive regulations, which could result in increased privacy and information security enforcement.
  • The majority of the provisions went into effect on January 1, 2023, and additional compliance investment and potential business process changes may be required.
  • Similar laws have passed in, or are being considered by, other states.
  • The enactment of such laws in other states could result in potentially conflicting requirements, which would make compliance challenging and costly. ​ The FTC and many state attorneys general continue to enforce federal and state consumer protection laws against companies for online collection, use, dissemination and security practices that appear to be unfair or deceptive.
  • The collection, use, disclosure, transfer, or other processing of personal data regarding individuals in the European Union (the “EU”), including personal health data, is subject to the General Data Protection Regulation, (EU) 2016/679 (the “GDPR”).
  • The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors.
  • The GDPR has expanded the definition of personal data to include coded data and requiring changes to informed consent practices and more detailed notices for clinical trial patients and investigators.
  • In addition, the GDPR imposes strict rules on the transfer of personal data to countries outside the EU, including the United States and, as a result, increases the scrutiny that clinical trial sites located in the European Economic Area should apply to transfers of personal data from such sites to countries that are considered to lack an adequate level of data protection, such as the United States.
  • The GDPR also permits data protection authorities to require destruction of improperly gathered or used personal information or impose substantial fines for violations of the GDPR, which can be up to 4% of global revenues or €20 million, whichever is greater, and it also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.
  • In addition, the GDPR provides that EU member states may make their own additional laws and regulations limiting the processing of personal data, including genetic, biometric, or health data. ​ Furthermore, since the United Kingdom is no longer part of the EU, its data protection regulatory regime is independent of the EU.
  • From January 1, 2021, companies have had to comply with both the GDPR and the United Kingdom GDPR, which, together with the amended United Kingdom Data Protection Act 2018, retains the GDPR in UK national law.
  • The relationship between the United Kingdom and the EU in relation to certain aspects of data protection law remains unclear.
  • The relative newness of the technology, the speed at which it is being adopted, and the paucity of laws, regulations or standards expressly and specifically governing its use increases these risks.
  • In addition, it can be very difficult to predict revenue growth rates of, or variability in demand for, new products and indications, which in some cases leads to difficult meeting product demand or, on the other hand, excess inventory and related financial charges.
  • We face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than we do.
  • In addition, Innoviva’s interests in our business may be different than our other stockholder s. ​ As of December 31, 2024, Innoviva owns 69.3% of our outstanding shares and 19,364,647 warrants to purchase shares of our Common Stock.
  • If Innoviva were to exercise the warrants held by them, they would hold approximately 80.0% of our issued and outstanding shares of Common Stock.
  • Between January 1, 2024 and December 31, 2024, the high and low sales prices of our Common Stock as reported on NYSE varied between $1.85 and $4.18 per share.
  • The stock market in general and the market for biotechnology and biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the companies’ operating performance, in particular during the last several years. ​ As of December 31, 2024, we had outstanding common warrants to purchase an aggregate of 19,365,847 shares of our Common Stock at a weighted-average exercise price of $3.59 per share.
  • We also have outstanding options to exercise 3,755,965 shares of our Common Stock at a weighted-average exercise price of $3.74 per share.
  • To the extent any of our outstanding warrants or options are exercised, additional shares of our Common Stock will be issued which will result in dilution to our security holders and could also have an adverse effect on the market price of our Common Stock.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations, and/or require us to relinquish rights to our technologies or product candidates .
  • Our operations could be disrupted if our information systems—or those of our vendors— fail, if we or our vendors are unsuccessful in implementing necessary upgrades, or if we or our vendors are subject to successful cyber-attacks.

and 5 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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