What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2026-03-25 compared with 2025-03-21 · 216 added, 106 removed, 183 unchanged (64% of the section changed)

3 unchanged sentences

See “Special Note Regarding Forward-Looking Statements.” Our actual results may differ substantially from those referred to herein due to a number of factors, including but not limited to risks described in the section entitled “Risk Factors” and elsewhere in this Annual Report on Form 10-K .

We are a clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacteria using our proprietary bacteriophage-based technology.

We are a late clinical-stage biotechnology company focused on the development of high-purity and potency, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using our proprietary bacteriophage-based technology.

We have completed three Phase 2 clinical trials to date.

We see bacteriophages as a potentially safer and effective alternative to antibiotics and an essential response to the growing bacterial resistance to current classes of antibiotics.

Bacteriophages or “phages” have a powerful and highly differentiated mechanism of action that enables binding to and killing of specific targeted bacteria while uniquely preserving the normal human microbiome or “healthy bacteria”.

This is in direct contrast to traditional broad-spectrum antibiotics which can alter the human microbiome increasing susceptibility to opportunistic pathogens, such as C.

This is in direct contrast to traditional broad-spectrum antibiotics which can alter the human microbiome increasing susceptibility to opportunistic pathogens, such as Clostridium difficile .

We believe that phages represent a promising means to effectively treat bacterial infections as an alternative to broad-spectrum antibiotics, especially for patients with bacterial infections resistant to current standard of care therapies, including the multidrug-resistant or “superbug” strains of bacteria.

We are a leading developer of clinical-stage phage therapeutics of high purity, and believe we are uniquely positioned to address the growing worldwide threat of antibiotic-resistant bacterial infections.

We have completed three critical Phase 2 trials, utilizing two distinct phage cocktails against two different bacterial pathogens with the potential to treat chronic pulmonary disease complicated by bacterial infection, as well as acute systemic bacterial infection.

We believe we are on a critical pathway towards pivotal Phase 3 clinical studies.

We are combining our proprietary approach and expertise in identifying, characterizing and developing both naturally occurring and engineered (synthetic) bacteriophages with our proprietary phage-specific host-engineered cGMP manufacturing capabilities to advance a target pipeline of high-quality bacteriophage product candidates for late-stage clinical development.

We have improved our manufacturing processes by significantly increasing phage titers and improving production efficiency with the goal of ensuring commercial viability.

We believe that we are uniquely advancing two lead candidates, referred to as AP-PA02 and AP-SA02, to address both chronic and acute bacterial infections.

Our first lead phage candidate, inhaled AP-PA02, is focused primarily on the treatment of chronic pulmonary infections due to P.

We are a leading developer of clinical-stage phage therapeutics of high purity and potency, and believe we are uniquely positioned to address the growing worldwide threat of antibiotic-resistant bacterial infections.

We are combining our proprietary approach and expertise in identifying, characterizing and developing both naturally occurring and engineered bacteriophages with our proprietary phage-specific host-engineered cGMP manufacturing capabilities to advance a clinical pipeline of high-quality bacteriophage product candidates.

We believe that we are uniquely advancing two distinct clinical candidates, referred to as AP-PA02 and AP-SA02, targeting two different bacterial pathogens with the potential to treat chronic pulmonary disease complicated by bacterial infection as well as acute systemic bacterial infection.

To date, we have completed three critical Phase 2 randomized, double-blind, placebo controlled clinical trials.

We have combined our clinical data with rigorous and innovative in vitro science to extend our knowledge of phage biology enabling continued enhancement of in vivo phage function.

Importantly, we have improved our manufacturing processes, which significantly increases phage titers and purity, and improves production efficiency.

Aligned with these improvements, we have been able to reproducibly produce high titer and high purity phages with lot-to-lot consistency, configuring our phage platform for full commercialization with the goal of ensuring commercial viability of our current and future phage product candidates across a variety of potential use cases.

We remain committed to our mission to evaluate phage-based therapeutics in randomized controlled clinical trials that evaluate safety and efficacy required to support potential regulatory approval and commercialization of our phage products as alternatives to traditional antibiotics, providing a potential method of treating patients suffering from drug-resistant and difficult-to-treat bacterial infections.

Pseudomonas aeruginosa Phage Product Candidate, AP-PA02

Clinical Development of AP-PA02 in Cystic Fibrosis:

Completed Phase 1b/2a Study

Our first phage candidate, inhaled AP-PA02, is focused primarily on the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa (“ P.

aeruginosa”) .

On October 14, 2020, we received the approval to proceed from the U.S.

1 unchanged sentence

In the first quarter of 2023, we announced positive topline results from the completed “SWARM- P.a.

” study – a Phase 1b/2a, multicenter, double-blind, randomized, placebo-controlled, single ascending dose and multiple ascending dose clinical trial to evaluate the safety and tolerability of inhaled AP-PA02 in subjects with cystic fibrosis and chronic pulmonary P.

aeruginosa infection.

6 unchanged sentences

This study was supported by the CFF, which granted us a Therapeutics Development Award of $5.0 million.

We received the full award’s amount, including the final payment of $0.3 million, in January 2024.

We received the full award’s amount, in 2024.

Following the promising Phase 1b/2a results of favorable safety and tolerability profile and plausible mechanism of action, an additional confirmatory Phase 2 trial was initiated in non-cystic fibrosis bronchiectasis (“NCFB”) patients with similar chronic pulmonary disease with infections due to P.

On February 22, 2022, Armata announced that it had received from the FDA the approval to proceed for our IND application for AP-PA02, in a second indication, non-cystic fibrosis bronchiectasis (“NCFB”).

Clinical Development of AP-PA02 in Non-Cystic Fibrosis Bronchiectasis:

Completed Phase 2 Study

On February 22, 2022, Armata announced that it had received from the FDA the approval to proceed for our IND application for AP-PA02, in a second indication, NCFB.

On December 19, 2024, Armata announced encouraging results from the completed “Tail wind ” study – a Phase 2 multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 in subjects with NCFB and chronic pulmonary P.

4 unchanged sentences

subjects in one cohort (cohort A) received inhaled AP-PA02 as monotherapy, while subjects in another cohort (cohort B) received inhaled AP-PA02 in combination with inhaled anti-pseudomonal antibiotic treatment.

Subjects in both cohorts were dosed at home by nebulization with study drug

administered every 12 hours for 10 days and were followed for approximately four weeks after receiving their last dose of study drug.

Subjects in both cohorts were dosed at home by nebulization with study drug administered every 12 hours for 10 days and were followed for approximately four weeks after receiving their last dose of study drug.

The primary efficacy endpoint was the reduction in P.

16 unchanged sentences

Results from the Phase 2 Tail wind study demonstrate the potential of Armata’s high-purity phage cocktail, AP-PA02, as a new monotherapy treatment alternative for chronic pulmonary disease caused by P.

aeruginosa infection, including drug-resistant bacteria, and indicate the potential for phage therapy to reduce reliance on chronic antibiotic use.

aeruginosa infection,

including drug-resistant bacteria, and indicate the potential for phage therapy to reduce reliance on chronic antibiotic use.

The Phase 2 Tail wind study represents the second successful clinical trial for AP-PA02, Armata’s lead pulmonary candidate, which was first evaluated in people with cystic fibrosis in the Phase 1b/2a SWARM- P.a.

trial that completed in 2023.

We believe the learnings on dose-schedule regimens gained from the two completed Phase 2 studies position us to define a safe and promising biologic correlation for a Phase 3 definitive trial which will aim to evaluate inhaled AP-PA02 as an alternative to antibiotics in chronic pulmonary P.

We believe the learnings on dose-schedule regimens gained from the two completed Phase 2 studies position us to define a safe and promising biologic correlation for a Phase 3 definitive trial to evaluate inhaled AP-PA02 as an alternative to antibiotics in chronic pulmonary P.

aeruginosa infection.

In parallel to developing novel phage therapeutics that target chronic bacterial infections, we have an acute bacterial infection clinical development plan focused on Staphylococcus aureus (“ S.

Contingent upon securing sufficient additional funding, we may at the appropriate time in the future resume clinical development of AP-PA02 for NCFB, which may include the execution of a definitive Phase 3 clinical trial.

We are also actively exploring potential strategic partnerships as a means to further advance this important program.

Pseudomonas aeruginosa Phage Product Candidate, AP-PA03:

Platform Expansion

Based on clinical findings with our intravenously administered S.

aureus phage product candidate AP-SA02 (described below), and the approach that the Company’s P.

aeruginosa phage cocktails are formulated with the same high potency and purity standards, we are exploring preclinical development of an intravenously administered P.

aeruginosa phage cocktail for the treatment of acute ventilator-associated pneumonia (“VAP”) and other severe and difficult-to-treat infections caused by antibiotic-resistant and multidrug-resistant P.

Recognizing the distinct physiology of acute hospitalized pneumonia compared to chronic respiratory infections such as CF and NCFB, we are developing a novel phage cocktail specifically for acute bacterial pneumonia and have leveraged our extensive P.

aeruginosa clinical isolate collection and phage library to identify AP-PA03 as a potential clinical candidate for this indication.

Contingent upon securing sufficient funding, we may at the appropriate time in the future file an IND application in order to initiate clinical development of AP-PA03 for the treatment of VAP.

Staphylococcus aureus Phage Product Candidate, AP-SA02

Clinical Development of AP-SA02 in Bacteremia:

Completed Phase 1b/2a Study

In parallel to developing novel phage therapeutics that target chronic bacterial infections, we have an acute bacterial infection clinical development program focused on S.

aureus bacteremia, a difficult-to-treat and often life-threatening human infection that can result in high morbidity and mortality and for which bacterial resistance to antibiotics is growing.

A key advantage of our phage manufacturing expertise is the purity profiles of our phage products, including AP-SA02, our phage product candidate for S.

We believe a key advantage of our phage manufacturing expertise is the purity profiles and the lot-to-lot consistency of our phage products, including AP-SA02, our phage product candidate for S.

this has enabled us to pursue treatment of complicated S.

aureus bacteremia, where repetitive intravenous dosing is required.

On June 15, 2020, we entered into an agreement (the “MTEC Agreement”) with the Medical Technology Enterprise Consortium (“MTEC”), pursuant to which we received a $15.0 million award and entered into a multi-year program administered by the U.S Department of Defense through MTEC and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.

On September 29, 2022, the MTEC Agreement was modified to increase the total award by $1.3 million to $16.3 million and extend the term into the second half of 2024.

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) .

aureus bacteremia, where repetitive intravenous (“IV”) dosing is required.

On November 17, 2021, we announced that we had received approval from the FDA to proceed with our IND application for AP-SA02.

On November 12, 2024, we announced completion of enrollment of the Phase 1b/2a diSArm study of intravenous AP-SA02 as a potential treatment for S.

On May 19, 2025, we announced positive topline data from the Phase 1b/2a diSArm study of intravenously administered AP-SA02 in complicated S.

aureus bacteremia.

The last patient final follow-up visit was completed on January 14, 2025.

During the Phase 2a portion of diSArm, Armata focused on evaluating clinical safety of higher intravenous doses of AP-SA02 and accelerating enrollment to arrive at topline data expeditiously.

The manufacture of highly purified phages using Armata's proprietary methods enabled dose escalation to 5E10 PFU every six hours (2E11 PFU every 24 hours) for five days without clinically significant adverse events.

In parallel with dose escalation, the evolution of two distinct blinded subsets of subjects receiving phage has been observed.

comprising approximately half of the treated group, has evidence of persistence of detectable phage in the blood providing early evidence of in vivo phage amplification and resultant release of phage progeny.

The Company anticipates topline data from the diSArm study in the first half of 2025 where it can explore the two aforementioned subsets in an unblinded manner.

Topline results are also expected to inform the optimal dose of AP-SA02 to be evaluated in a larger definitive efficacy study.

Data from this Phase 1b/2a study will be invaluable for a follow-on trial that is being designed to demonstrate efficacy of AP-SA02 in treating S.

The diSArm study (NCT05184764) was a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to BAT compared to BAT alone (placebo) for the treatment of adults with complicated SAB.

All doses of AP-SA02 were dosed intravenously every six hours for five days.

The primary clinical efficacy endpoint for the Phase 2a portion of the diSArm study was clinical outcome (responder rate) in subjects with complicated bacteremia, measured at (i) TOC for AP-SA02, defined as one week following the end of IV treatment with AP-SA02 (day 12), (ii) TOC for BAT, defined as one week following the end of IV BAT, and (iii) end of study (“EOS”), defined as four weeks following the end of IV BAT.

Clinical outcome was evaluated by both the blinded site investigators and a blinded Clinical Efficacy Adjudication Committee (the “CEAC”) in the intent-to-treat (“ITT”) population.

Safety and efficacy were assessed in the ITT population, which included all subjects (n=50) who received at least one dose of AP-SA02 or placebo.

The Phase 2a study enrolled and dosed 42 patients, with 29 randomized to AP-SA02 in addition to BAT and 13 to placebo (BAT alone).

MRSA was the causative pathogen in ~38% of both the AP-SA02 and placebo groups.

AP-SA02 was well-tolerated with no serious adverse events related to the study drug.

Two subjects had adverse events that were possibly related to the study drug:

one with transient liver enzyme elevation and one with hypersensitivity that resolved with discontinuation of vancomycin.

A statistically significant increase in clinical response rate was observed at TOC for AP-SA02 (day 12) in AP-SA02 treated subjects (88%;

21/24) versus placebo (58%;

7/12) (p = 0.047) as assessed by blinded site investigators, and 83% (20/24) in the AP-SA02 group versus 58% (7/12) in the placebo group as assessed by the blinded CEAC.

At TOC for BAT and at EOS, 100% of the AP-SA02 treated subjects had clinically responded (p = 0.017) versus 25% of placebo subjects considered non-responsive due to either relapse or treatment failure, consistent with the non-responder rate reported in the literature for recent Phase 3 trials.

Of note, the clinical response with AP-SA02 occurred regardless of whether subjects were infected with MSSA or MRSA.

All subjects infected with MRSA and treated with AP-SA02 and BAT cleared their infection by TOC for BAT with no evidence of relapse through EOS, as compared to the relapse rate of BAT alone as noted above.

Supporting the investigator assessment, clinical outcome was assessed by the CEAC, who agreed that subjects who received placebo had a 22% and 25% non-responder rate at TOC with BAT and at EOS, respectively, while 100% of the subjects who received AP-SA02 clinically responded (p = 0.025:

Additionally, and consistent with the clinical response rate, patients treated with AP-SA02 showed trends toward rapid normalization of key predictors of mortality and complications in SAB including C-reactive protein and interleukin-10, shorter time to negative blood culture, quicker time to resolution of signs and symptoms at the infection site, shorter intensive care unit and hospital utilization.

Clinical efficacy was observed independent of the BAT utilized, in that all patients responded despite receiving different classes of antibiotics.

The active and placebo arms were well-matched for antibiotics utilized.

The clinical response rate also occurred independent of the site of infection, which were well-matched between the active and placebo arms, and were diverse ranging from endocarditis, to osteomyelitis, to septic joints, to deep wounds, and pneumonia.

Moreover, phages in AP-SA02 administered systemically by IV push, were able to hone to the site of infection, bind to, penetrate and kill the target bacteria, enabling phage progeny to exit the burst bacteria and reenter the intravascular space including further target any remaining local bacteria.

Phage are not able to continue to exist and replicate once all target bacteria have been killed.

Defined and reproducible laboratory derived stable genomic variants present in the AP-SA02 drug product may provide an immediate advantage, enabling rapid, strain-specific response to each patient’s S.

aureus isolate.

These characterized variants can expand from as little as 2% to dominance when infecting certain patient isolates in vitro , highlighting that these variants are favored for their enhanced ability to infect those clinical strains and the importance of integrating this diversity into Armata’s phage cocktail from the outset.

This inherent flexibility may be central to achieving optimal therapeutic efficacy in the clinic.

● AP-SA02, combined with BAT, had a higher and earlier cure rate compared to placebo in patients with complicated SAB at day 12 as assessed by both blinded site investigators and independent adjudicators.

● No patients who received AP-SA02 demonstrated non-response or relapse at one week post-BAT or at EOS, as assessed by both blinded site investigators and the independent adjudication committee, compared with approximately 25% non-response or relapse in the placebo group.

● AP-SA02 appears safe with clinical efficacy against both MRSA and MSSA and trends toward earlier resolution and shorter hospitalization, with no evidence of relapse four weeks post-therapy.

● We previously demonstrated the persistence of AP-SA02 in the IV space on multiple days one hour post IV push.

These trial results support AP-SA02 homing to different sites of infection, presumably penetrating

biofilms, and infecting and lysing the target S.

aureus bacteria, independent of both antibiotic resistance patterns and site of infection.

● Defined phage variants in AP-SA02 drug product ensure an intrinsic adaptive mechanism — a flexibility that may be key to achieving effective phage therapy from patient to patient.

On October 22, 2025, we highlighted the positive results from our Phase 2a diSArm clinical study of AP-SA02 in an oral presentation at IDWeek 2025 TM .

The abstract, titled, “A Phase 2a Randomized, Double-Blind, Controlled Trial of the Efficacy and Safety of an Intravenous (IV) Bacteriophage Cocktail (AP-SA02) vs.

Placebo in Combination with Best Available Antibiotic Therapy (BAT) in Patients with Complicated Staphylococcus aureus Bacteremia,” was accepted as a late-breaking oral presentation, and was presented by Dr.

Miller, M.D., M.P.H., Professor of Medicine, David Geffen School of Medicine at UCLA, Chief, Division of Infectious Diseases at Harbor-UCLA Medical Center and the Lundquist Institute.

The results from our Phase 1b/2a diSArm study are an important step forward in our effort to confirm the potent antimicrobial activity of phage therapy and the completion of the study represents a significant milestone in the development of AP-SA02, moving us one step closer to introducing an effective new treatment option to patients suffering from complicated SAB.

This is the first clear evidence in a randomized controlled trial of the efficacy of phage against a serious systemic pathogen that is responsible for significant morbidity and mortality in the United States.

Findings from the Phase 1b/2a study, including the favorable safety and tolerability profile of AP-SA02, inform the design of a larger definitive efficacy study to demonstrate superiority of AP-SA02 in treating complicated SAB.

In January 2026, the Company announced the conclusion of an EOP2 meeting written response from the FDA.

The FDA’s CBER division, upon reviewing our detailed EOP2 meeting package, confirmed that the safety and efficacy data from our Phase 2a diSArm study support advancement to Phase 3.

The FDA provided critical guidance on key elements of the Phase 3 clinical study design, which will assess the superiority of AP-SA02 over the current standard of care for the treatment of complicated S.

aureus bacteremia.

We anticipate findings from the Phase 1b/2a study will provide the basis for constructing a robust trial strategy for registration which can be the basis for an End-of-Phase-2 meeting with the FDA that enables us to obtain agreement on a path to approval.

We are committed to developing a definitive efficacy trial focused on phage as an alternative to broad-spectrum antibiotics and/or antibiotic sparing to decrease the utilization of broad-spectrum antibiotics and their detrimental impact on the normal human microbiome.

On August 1, 2022, we announced FDA approval to proceed with our IND application for AP-SA02 in a second indication, prosthetic joint infections (“PJI”) with S.

The FDA provided comments on Chemistry, Manufacturing, and Controls (“CMC”) which we are aligning with our existing Phase 3 manufacturing and quality strategy.

The FDA also included recommendations for the future BLA.

As of the date of this filing, we are already addressing many of the clinical and CMC comments from the FDA.

On February 20, 2026, under Section 505E of the Federal Food, Drug, and Cosmetic Act, the FDA designated AP-SA02 for intravenous use as a QIDP for adjunct treatment of complicated bacteremia caused by methicillin-sensitive or methicillin-resistant S.

To achieve QIDP designation, a drug candidate must be intended to treat serious or life-threatening infections, particularly those caused by bacteria and fungi that are resistant to treatment, or that treat qualifying resistant pathogens identified by the FDA.

The QIDP designation makes AP-SA02 eligible to benefit from certain incentives for the development of new antibacterials provided under the Generating Antibiotic Incentives Now (“GAIN”) Act, including an additional five-year extension of Hatch-Waxman market exclusivity.

Further, the QIDP designation makes AP-SA02 eligible for Fast Track status, which provides an opportunity for more frequent meetings and communication with the FDA, priority and rolling review, leading to potential accelerated approval of its BLA.

As of the date of this filing, the Company has submitted to the FDA a request for Fast Track Designation for AP-SA02.

Department of Defense (the “DoD”) through MTEC and managed by the Naval Medical Research Command – Naval Advanced Medical Development with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.

On September 29, 2022, the MTEC Agreement was modified to increase the total award by $1.3 million to $16.3 million and extend the term into the second half of 2024.

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.

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 AP-SA02 for the treatment of adults

with complicated S.

aureus bacteremia (the “diSArm” study), and to support activities related to the EOP2 meeting with the FDA.

Clinical Development of AP-SA02 in Bacteremia:

Phase 3 Superiority Study

The current proposed Phase 3 clinical study design, which incorporates feedback from the Company’s EOP2 meeting with the FDA, is intended to assess the superiority of AP-SA02 administered as an adjunct to 4–6 weeks of BAT for the treatment of adults with complicated S.

aureus bacteremia.

The proposed trial design, which incorporates feedback from the Company’s EOP2 meeting with the FDA, will evaluate clinical response at 7 days post BAT and/or 28 days post BAT as the primary study endpoint, and defined as resolution of all baseline signs and symptoms of bacteremia and negative blood cultures.

Secondary endpoints include clinical response at day 14 (TOC), time to hospital discharge, microbiologic eradication evidenced by two consecutive negative blood cultures, and S.

aureus -specific and all-cause mortality at day 14, 7 days post BAT and/or 28 days post BAT.

The study is expected to enroll approximately 450 patients in a 2:1 randomization, powered to detect a 15% absolute improvement with 90% power at a 0.05 alpha level, and is designed to provide safety data from approximately 300 AP-SA02-treated subjects (receiving the full 7-day dose) to support a potential BLA.

Safety and healthcare resource impact analyses will be included.

The Phase 3 study is anticipated to initiate in the second half of 2026.

aureus Bacteremia Clinical Strategy:

Moving AP-SA02 to Frontline Therapy, Expanding Patient Populations and Indications

The Company believes that, if clinical superiority of AP-SA02 is demonstrated in the Phase 3 study for registration in adults with complicated S.

aureus bacteremia, it is plausible the Phase 3 safety and efficacy data may potentially drive changes to infectious disease clinical treatment guidelines, requiring the use of AP-SA02 with antibiotics as new standard of care.

With demonstration of superiority and following a potential initial approval of AP-SA02 in adults with complicated S.

aureus bacteremia, the Company believes there may be additional development opportunities for AP-SA02, including use as adjunct therapy with shorter antibiotic treatment durations, and evaluation of AP-SA02 as a potential front-line therapy.

Moreover, a potential future bridging study may support label expansion, including expanding into adults with uncomplicated S.

aureus bacteremia, and a potential opportunity to expand into the pediatric population given the high titer formulation of AP-SA02 enables administration at small volume doses.

Additional Clinical Indications for AP-SA02

On August 1, 2022, we announced FDA approval to proceed with our IND application for AP-SA02 in a second indication, PJI with S.

We had planned to initiate a Phase 1b/2a trial;

1 unchanged sentence

Driven by data from the bacteremia study, and with sufficient funding, we may in the future initiate a Phase 1b/2a trial to assess the safety and tolerability of intravenous and intra-articular AP-SA02 as an adjunct to standard of care antibiotics in adults undergoing treatment of periprosthetic joint infections and/or wound infections caused by S.

We remain committed to our mission to evaluate phage-based therapeutics in randomized controlled clinical trials that evaluate safety and efficiacy required to support potential regulatory approval and commercialization of our phage products as alternatives to traditional antibiotics, providing a potential method of treating patients suffering from drug-resistant and difficult-to-treat bacterial infections.

The following chart summarizes the status of our phage product candidate development programs and partners.

5 unchanged sentences

We may also use a portion of our existing cash and cash equivalents for the potential acquisition of, or investment in, product candidates, technologies, formulations or companies that complement our business, although we have no current understandings, commitments or agreements to do so.

Our existing cash and cash equivalents of $9.3 million as of December 31, 2024 will not be sufficient to enable us to complete all necessary development of any potential product candidates and fund our operations for the next twelve months from the date the consolidated financial statements included elsewhere in this Annual Report on Form 10-K are

Our existing cash and cash equivalents of $8.7 million as of December 31, 2025 will not be sufficient to enable us to complete all necessary development of any potential product candidates and fund our operations for the next twelve months from the date the consolidated financial statements included elsewhere in this Annual Report on Form 10-K are issued.

These circumstances raise substantial doubt about the Company’s ability to continue as a going concern.

5 unchanged sentences

Recent Events

MTEC Agreement Modification

In July 2024, we extended the MTEC Agreement to August 2025 and increased the amount of the award by $5.3 million to a total of $21.6 million.

We will recognize an increase in grant revenue from the third quarter of 2024 until the full amount of the amended award is utilized.

2025 Credit Agreement

On March 12, 2025, the Company entered the 2025 Credit Agreement for the 2025 Loan in an aggregate amount of $10.0 million.

The 2025 Loan bears interest at an annual rate of 14.0% and matures on March 12, 2026.

Credit Agreements and Warrants Extensions

On January 23, 2026, we entered into amendments to the March 2025 Credit Agreement, the 2024 Credit Agreement, the 2023 Credit Agreement, and the Convertible Credit Agreement with Innoviva Strategic Opportunities LLC (“Innoviva Sub”), extending the maturity dates to June 1, 2027.

In addition, we amended certain outstanding Innoviva Sub warrants to extend their expiration dates to January 26, 2031, and amended the related voting agreement to align with the revised warrant expiration date or FDA approval, as applicable.

Refer to Note 7, “ Convertible Loan ” and

Note 8, “ Term Debt ”, in our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional details.

December 2025 Sales Agreement

On December 1, 2025, we entered into a Capital on Demand™ Sales Agreement (the “Sales Agreement”) with JonesTrading Institutional Services LLC (“Jones”), relating to the offer and sale of shares of its common stock.

In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $100,000,000 from time to time subject to certain conditions, through or to Jones, acting as agent or principal.

August 2025 Credit Agreement

On August 11, 2025, we entered into a credit and security agreement (the “August 2025 Credit Agreement”) for a loan in the aggregate amount of $15.0 million (the “August 2025 Loan”) with Innoviva Sub.

The August 2025 Loan bears interest at an annual rate of 14.0% and matures on January 11, 2029.

Principal and accrued interest are payable at maturity.

Repayment of the 2025 Loan is guaranteed by the Company’s domestic subsidiaries, and the loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

Concurrently with the execution of the 2025 Credit Agreement, the Company entered into amendments to (i) the Convertible Loan and Convertible Credit Agreement, (ii) the 2023 Loan and 2023 Credit Agreement, and (iii) the 2024 Loan and 2024 Credit Agreement, which, among other things, extended the maturity date of the Convertible Loan, 2023 Loan and 2024 Loan, respectively, to March 12, 2026.

2024 Credit Agreement

On March 4, 2024, the Company entered into the 2024 Credit Agreement for the 2024 Loan in an aggregate amount of $35.0 million.

The 2024 Loan bears interest at an annual rate of 14.0% and was scheduled to mature on June 4, 2025.

Repayment of the August 2025 Loan is guaranteed by our domestic subsidiaries, and the loan is secured by substantially all of our assets and the subsidiary guarantors.

March 2025 Credit Agreement

On March 12, 2025, we entered into a credit and security agreement (the “March 2025 Credit Agreement”) for a loan in an aggregate amount of $10.0 million (the “March 2025 Loan”) with Innoviva Sub.

The March 2025 Loan bears interest at an annual rate of 14.0% and matures on June 1, 2027.

Principal and accrued interest are payable at maturity.

Repayment of the 2024 Loan is guaranteed by the Company’s domestic subsidiaries, and the loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

Concurrently with the execution of the 2024 Credit Agreement, the Company amended certain provisions of the Convertible Loan and Convertible Credit Agreement and the 2023 Loan and 2023 Credit Agreement to, among other things, conform certain terms relating to permitted indebtedness and permitted liens.

On March 12, 2025, the Company executed an amendment to the 2024 Credit Agreement which, among other things, extended the 2024 Loan maturity date to March 12, 2026.

Repayment of the March 2025 Loan is guaranteed by our domestic subsidiaries, and the loan is secured by substantially all of our assets and the subsidiary guarantors.

MTEC Agreement Modification

On July 2, 2025, the MTEC Agreement was modified to extend the term to March 31, 2026.

We will continue to recognize additional grant and award revenue until the full amount of the amended award is utilized.

2024 Credit Agreement

On July 10, 2023, the Company entered into the 2023 Credit Agreement.

The 2023 Credit Agreement provides for the 2023 Loan, a secured term loan facility in an aggregate amount of $25.0 million at an interest rate of 14.0% per annum, and was scheduled to mature on January 10, 2025.

On March 4, 2024, we entered into the 2024 Credit Agreement for the 2024 Loan in an aggregate amount of $35.0 million.

The 2024 Loan bears interest at an annual rate of 14.0% and matures on June 1, 2027.

Principal and accrued interest are payable at maturity.

Repayment of the 2023 Loan is guaranteed by the Company’s domestic subsidiaries, and the 2023 Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

On November 12, 2024, the Company executed an amendment to the 2023 Credit Agreement, which, among other things, extended the 2023 Loan maturity date to January 10, 2026.

On March 12, 2025, the Company executed a

subsequent amendment to the 2023 Credit Agreement which, among other things, extended the 2023 Loan maturity date to March 12, 2026.

Repayment of the 2024 Loan is guaranteed by our domestic subsidiaries, and the loan is secured by substantially all of our assets and the subsidiary guarantors.

Concurrently with the execution of the 2024 Credit Agreement, we amended certain provisions of the Convertible Loan and Convertible Credit Agreement and the 2023 Loan and 2023 Credit Agreement to, among other things, conform certain terms relating to permitted indebtedness and permitted liens.

Results of Operations

2 unchanged sentences

Year Ended December 31,

Grant revenue

Grant and award revenue

Operating expenses

1 unchanged sentence

General and administrative

Impairment expense

Total operating expenses

4 unchanged sentences

Change in fair value of the Convertible Loan

Gain (loss) on debt and the Convertible Loan extinguishments

Gain on debt and the Convertible Loan extinguishments

Total other income (expense), net

Grant Revenue

We recognized $5.2 million and $4.5 million of grant revenue for the years ended December 31, 2024 and 2023, respectively, which represents MTEC’s share of the clinical development costs incurred for our AP-SA02 program for the treatment of S.

aureus bacteremia.

Grant and Award Revenue

We recognized $4.9 million and $5.2 million of grant and award revenue for the years ended December 31, 2025 and 2024, respectively, which represents MTEC’s share of the clinical development costs incurred for our AP-SA02 program for the treatment of SAB.

Research and Development

2 unchanged sentences

External costs:

Clinical trial expenses

Clinical trials

Other research and development costs, including consulting, laboratory supplies and other

4 unchanged sentences

Total research and development expense:

Research and development expenses increased by $0.6 million, from $33.8 million for the year ended December 31, 2023 to $34.4 million for the year ended December 31, 2024.

Clinical trial costs increased by $0.3 million, from $10.0 million for the year ended December 31, 2023, to $10.3 million for the year ended December 31, 2024.

The increase is primarily due to a $2.2 million increase in the AP-PA02 NCFB study as the study is at an active stage with significant developments during the year ended December 31, 2024, offset by a $1.9 million decrease in other clinical trial expenses, based on the progress of our clinical trials.

Research and development expenses decreased by $10.7 million, from $34.4 million for the year ended December 31, 2024 to $23.7 million for the year ended December 31, 2025, primarily driven by lower clinical trial spending as AP-PA02 NCFB and SA study activities wound down.

Clinical trial costs decreased by $8.3 million, from $10.3 million for the year ended December 31, 2024, to $2.0 million for the year ended December 31, 2025.

The decrease was primarily attributable to a $6.4 million decrease in AP-PA02 NCFB trial costs, a $1.7 million decrease in SA study costs, and a $0.2 million decrease in the CF study.

Other external research and development costs decreased by $0.4 million from $3.4 million for the year ended December 31, 2024 to $3.0 million for the year ended December 31, 2025.

We recognized zero and $0.3 million credits to research and development expenses related to the CFF grant for the years ended December 31, 2024 and 2023, respectively.

Our consultant expenses decreased by $0.9 million, spending on outsource service contracts decreased by $0.4 million, laboratory supplies decreased by $0.2 million.

The decrease was primarily due to a decrease of $0.9 million in consulting expenses, partially offset by increases of $0.2 million in lab supplies and $0.3 million in equipment and other service contracts.

Our external research and development expenses by project for the years ended December 31, 2025 and 2024 were as follows (in thousands):

6 unchanged sentences

* Expenses not allocated by projects include consultants, lab supplies and outsource service expenses

Personnel-related costs, including employee payroll and related expenses, increased by $1.3 million, from $9.7 million for the year ended December 31, 2023 to $11.0 million for the year ended December 31, 2024, largely due to an increase of $0.9 million in incentive compensation expense, whereas no such expense was incurred during the year ended December 31, 2023, an increase of $0.7 million in severance expense, offset by a decrease of $0.3 million in employee stock-based compensation expenses, which was primarily due to the full vesting of awards issued in prior periods.

Facilities and overheads increased by $0.3 million from $9.5 million for the year ended December 31, 2023 to $9.8 million for the year ended December 31, 2024, largely as a result of an increase in lease expense of $1.0 million, partially offset by a decrease of $0.7 million in expensed noncapitalizable lab equipment, lab equipment maintenance and other research and development costs.

Personnel-related costs, including employee payroll and related expenses, decreased by $1.7 million, from $10.9 million for the year ended December 31, 2024 to $9.2 million for the year ended December 31, 2025.

This decrease was mainly driven by a $1.4 million decrease in incentive compensation, salaries and wages, vacation and insurance due to a reduction in personnel as we maximize efficiency for product development and a decrease of $0.8 million in severance expense.

This decrease was partially offset by increases of $0.3 million in stock-based compensation expense and $0.2 million in employee training expenses.

Facilities and overhead costs decreased by $0.3 million from $9.8 million for the year ended December 31, 2024 to $9.5 million for the year ended December 31, 2025, mainly due to a decrease of $0.4 million in lease expense partially offset by a $0.1 million increase in depreciation costs.

General and Administrative

General and administrative expenses were $12.4 million and $13.2 million for the years ended December 31, 2025 and 2024, respectively.

The increase of $1.4 million is primarily related to an increase of $2.1 million in personnel related costs, including $2.3 million in stock-based compensation expense, mainly related to the awards granted in March 2024, an increase of $0.7 million in salaries, an increase of $0.2 million in incentive compensation expense, offset by a $1.1 million decrease in severance expense.

The increase in general and administrative expenses was also attributable to an increase of $0.5 million in lease expenses, an increase of $0.8 million in other facilities, general, administrative and overhead expenses, partially offset by a decrease of $2.0 million in legal, accounting and other consulting expenses.

The decrease of $0.8 million was primarily related to a decrease of $0.7 million in consulting fees as we continue to streamline and increase in-house expertise .

Impairment Expense

During the year ended December 31, 2025, an impairment charge of $5.4 million was recognized related to our office and research and development space under a non-cancelable operating lease in Marina del Rey, California.

The impairment resulted from changes in the anticipated timeline in our plan to sublease the vacated space.

There was no impairment of long-lived assets during the year ended December 31, 2024.

Interest Income

1 unchanged sentence

Interest Expense

We recognized interest expense of $10.7 million and $2.6 million for the years ended December 31, 2024 and 2023, respectively, which relates to the interest and the amortization of debt discount and issuance costs for the 2023 Loan and 2024 Loan received from Innoviva in July 2023 and March 2024, respectively.

Interest expense is accrued at each period end and is payable at the loan maturity.

We recognized interest expense of $16.6 million and $10.7 million for the years ended December 31, 2025 and 2024, respectively.

The increase is primarily related to increased debt balances as compared to the prior year period.

Interest expense related to the interest expenses and the amortization of debt discount and issuance costs for the 2023 Loan, 2024 Loan, March 2025 Loan and August 2025 Loan.

Stated interest is accrued and is payable at the maturity of the 2023 Loan, 2024 Loan and March 2025 Loan in June 2027, and the August 2025 Loan in January 2029.

Refer to Note 8, “ Term Debt ”, in our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional details.

Change in Fair Value of Convertible Loan

We recognized a fair value of the Convertible Loan gain of $31.4 million for the year ended December 31, 2024 and the Convertible Loan loss of $21.8 million for the year ended December 31, 2023.

The Convertible Loan is accounted at fair value using a weighted probability of various settlement scenarios of the Convertible Loan during its term discounted to each reporting date.

We recognized a loss of $121.0 million and a gain of $31.4 million for the years ended December 31, 2025 and 2024, respectively.

The Convertible Loan received from Innoviva Sub in January 2023 and amended in July 2023, November 2024, March 2025, and January 2026 is accounted for at fair value using a weighted probability of various settlement scenarios of the Convertible Loan during its term discounted to each reporting date.

Conversion option scenarios are valued using an option pricing model with significant assumptions and estimates such as volatility, expected term and risk-free interest rates.

Changes in fair value for the years ended December 31, 2025 and 2024 were primarily due to fluctuations of our stock price.

Refer to Note 7, “ Convertible Loan ”, in our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional details.

Gain (Loss) on Debt and Convertible Loan Extinguishments

Gain on Debt and Convertible Loan Extinguishments

We recognized a gain of $2.2 million on debt extinguishment for the year ended December 31, 2024, which relates to the amendments to the 2023 Loan and Convertible Loan on November 12, 2024.

1 unchanged sentence

Refer to Note 8, “ Term Debt ” and Note 7, “ Convertible Loan ”, in our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional details.

We recognized a loss of $3.9 million on the Convertible Loan extinguishment for the year ended December 31, 2023, which relates to the amendment to the Convertible Loan on July 10, 2023.

Refer to Note 7, “ Convertible Loan” , in our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional details.

Liquidity, Capital Resources and Financial Condition

5 unchanged sentences

We may not be able to secure additional financing in a timely manner or on favorable terms, if at all .

On March 12, 2025, the Company entered the 2025 Credit Agreement for the 2025 Loan in an aggregate amount of $10.0 million.

The 2025 Loan bears interest at an annual rate of 14.0% and matures on March 12, 2026.

On January 23, 2026, we entered into amendments to the March 2025 Credit Agreement, the 2024 Credit Agreement, the 2023 Credit Agreement and the Convertible Credit Agreement with Innoviva Sub, extending the maturity dates to June 1, 2027.

Refer to Note 7, “ Convertible Loan ” and Note 8, “ Term Debt ”, in our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional details.

In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an

aggregate offering price of up to $100,000,000 from time to time subject to certain conditions, through or to Jones, acting as agent or principal.

On August 11, 2025, we entered into the August 2025 Credit Agreement for a loan in the aggregate amount of $15.0 million.

The August 2025 Loan bears interest at an annual rate of 14.0% and matures on January 11, 2029.

Principal and accrued interest are payable at maturity.

Repayment of the 2025 Loan is guaranteed by the Company’s domestic subsidiaries, and the loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

In July 2024, we amended the MTEC Agreement and increased the amount of the award by $5.3 million to a total of $21.6 million.

We will recognize grant revenue from the third quarter of 2024 until the full amount of the amended award is utilized.

Repayment of the August 2025 Loan is guaranteed by our domestic subsidiaries, and the loan is secured by substantially all of our assets and the subsidiary guarantors.

On March 12, 2025, we entered into the March 2025 Credit Agreement for the March 2025 Loan in an aggregate amount of $10.0 million.

The March 2025 Loan bears interest at an annual rate of 14.0% and matures on June 1, 2027.

Principal and accrued interest are payable at maturity.

Repayment of the March 2025 Loan is guaranteed by our domestic subsidiaries, and the loan is secured by substantially all of our assets and the subsidiary guarantors.

On July 29, 2024, we amended the MTEC Agreement and increased the amount of the award by $5.3 million to a total of $21.6 million.

We will recognize grant and award revenue from the third quarter of 2024 until the full amount of the amended award is utilized.

On July 2, 2025, the MTEC Agreement was modified to extend the term to March 31, 2026.

We will continue to recognize additional grant and award revenue until the full amount of the amended award is utilized.

Future Capital Requirements

22 unchanged sentences

Year Ended December 31,

Net cash used in operating activities

Net cash used in investing activities

Net cash provided by financing activities

Net decrease in cash, cash equivalents and restricted cash

Cash Flows Used in Operating Activities

Net cash provided by (used in):

Operating activities

Investing activities

Financing activities

Net change in cash, cash equivalents and restricted cash

Cash From Operating Activities

Net cash used in operating activities was $25.8 million and $37.6 million for the years ended December 31, 2025 and 2024, respectively.

Cash used in operating activities in the year ended December 31, 2025 was primarily due to our net loss for the period of $173.8 million, adjusted by non-cash net changes of $96.1 million and a net change of $1.4 million in our net operating assets and liabilities.

The non-cash items consist of $31.4 million related to a gain from change in fair value of our Convertible Loan, $2.2 million extinguishment gain related to the extension of our Convertible Loan and 2023 Loan maturity to January 10, 2026, $10.8 million of non-cash interest expense on outstanding balances of the 2023 Loan and the 2024 Loan, $1.3 million related to depreciation and amortization expense, $2.1 million related to change in right-of-use asset, $2.9 million related to stock-based compensation expense.

The changes in our net operating assets and liabilities were primarily due to a decrease of $5.0 million in operating lease liability, mainly related to payments for our new leased facility construction, which was completed in 2024, and rent payments, $3.8 million decrease in accounts payable and accrued liabilities, partially offset by a decrease of $5.1 million in prepaid expenses and other assets and an increase of $1.5 million in accrued compensation.

Cash used in operating activities in the year ended December 31, 2023 was primarily due to our net loss for the period of $69.0 million, adjusted by non-cash net expenses of $31.3 million and a net change of $9.7 million in our net operating assets and liabilities.

The non-cash items consist of $21.8 million related to a loss from change in fair value of the Convertible Loan, $3.9 million related to the Convertible Loan extinguishment loss, $2.6 million of non-cash interest expense on the Convertible Loan, $1.0 million related to depreciation and amortization expense, $1.0 million related to change in right-of-use asset, $0.9 million related to stock-based compensation expense.

The changes in our net operating assets and liabilities were primarily due to a decrease of $13.5 million in operating lease liability, mainly related to payments for our new leased facility construction, and rent payments, a decrease of $1.1 million in accrued compensation, partially offset by a decrease of $4.8 million in prepaid expenses and other assets.

Cash Flows Used in Investing Activities

Net cash used in investing activities was $1.9 million and $8.1 million for the years ended December 31, 2024 and 2023, respectively, which is mostly attributable to purchases of laboratory and manufacturing equipment acquired for our new manufacturing facility.

We expect our spending for property and equipment to decrease as the construction of our manufacturing facility was completed as of December 31, 2024.

Cash Flows from Financing Activities

The non-cash items consist of $121.0 million related to a loss from the change in fair value of our Convertible Loan, $16.6 million of non-cash interest expense on the 2023 Loan, 2024 Loan, March 2025 Loan, and August 2025 Loan, $1.5 million related to depreciation expense, $2.4 million related to the change in right-of-use asset, $2.6 million related to stock-based compensation expense, and $5.4 million related to an impairment expense.

The changes in our net operating assets and liabilities were primarily due to a decrease of $1.0 million in operating lease liabilities, $0.3 million decrease in accounts payable and accrued liabilities, and $0.1 million decrease in accrued compensation.

Cash used in operating activities in the year ended December 31, 2024 was primarily due to our net loss for the period of $18.9 million, adjusted by non-cash net changes of $16.5 million and a net change of $2.1 million in our net operating assets and liabilities.

The non-cash items consist of $31.4 million related to a gain from change in fair value of our Convertible Loan, $2.2 million extinguishment gain related to the extension of our Convertible Loan and 2023 Loan maturity to January 10, 2026, $10.8 million of non-cash interest expense on outstanding balances of the 2023 Loan and the 2024 Loan, $1.3 million related to depreciation expense, $2.1 million related to change in right-of-use asset, $2.9 million related to stock-based compensation expense.

accrued liabilities, partially offset by a decrease of $5.1 million in prepaid expenses and other assets and an increase of $1.5 million in accrued compensation.

Cash From Investing Activities

Net cash used in investing activities was $0.5 million and $1.9 million for the years ended December 31, 2025 and 2024, respectively, which is attributable to purchases of laboratory and manufacturing equipment for office, laboratory and manufacturing space at our leased facility in Los Angeles, California.

Cash From Financing Activities

Cash provided by financing activities for the year ended December 31, 2025 was $25.6 million, which consisted primarily of $25.0 million in net proceeds from the issuance of term debt and $0.6 million in option exercise proceeds.

Cash provided by financing activities for the year ended December 31, 2024 was $35.0 million, which consisted primarily of net proceeds from the issuance of the 2024 Loan.

Cash provided by financing activities for the year ended December 31, 2023 was $54.0 million, which consisted primarily of net proceeds from the issuance of the Convertible Loan of $29.1 million and net proceeds from the issuance of long-term debt of $24.9 million.

Off-Balance Sheet Arrangements

17 unchanged sentences

Judgments and estimates are made in determining the accrued balances at the end of the reporting period.

Payments made under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets until the services are rendered.

Payments made under these arrangements in advance of the

performance of the related services are recorded as prepaid expenses and other current assets until the services are rendered.

To date, there have been no material differences between estimates of such expenses and the amounts actually incurred.

Fair Value Estimate of the Convertible Loan

In January 2023, we entered into the Convertible Credit Agreement with Innoviva, which was amended in July 2023 and November 2024.

In January 2023, we entered into the Convertible Credit Agreement with Innoviva Sub, which was amended in July 2023, November 2024, and March 2025.

The Convertible Loan includes various conversion and repayment options, including the conversion of principal and accrued interest into shares of our Common Stock upon a Qualified Financing and our option to repay the Convertible Loan prior to maturity.

2 unchanged sentences

We estimate the fair value using a weighted probability of various settlement scenarios during the Convertible Loan term discounted to each reporting date.

estimate the fair value of the conversion option scenarios, we use an option pricing model with assumptions, such as volatility, expected term and risk-free interest rates.

To estimate the fair value of the conversion option scenarios, we use an option pricing model with assumptions, such as volatility, expected term and risk-free interest rates.

Changes in the fair value of our Common Stock and probabilities of scenarios significantly impact the fair value of the Convertible Loan.

We expect to continue making these estimates until the Convertible Loan conversion or its maturity in January 2026.

We expect to continue making these estimates until the Convertible Loan conversion or its maturity in June 2027.

As of December 31, 2025, we estimated the fair value of the Convertible Loan to be $153.9 million.

For the year ended December 31, 2024, we recognized a change in fair value gain of $31.4 million in the consolidated statements of operations and comprehensive loss.

For the year ended December 31, 2025, we recognized a change in fair value loss of $121.0 million in the consolidated statements of operations and comprehensive loss.

Recent Accounting Pronouncements

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis