03/25/2026 | Press release | Distributed by Public on 03/25/2026 14:19
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the consolidated financial statements and the related notes contained elsewhere in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis are set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. 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.
Overview
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 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 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. Food and Drug Administration (the "FDA") for our Investigational New Drug ("IND") application for AP-PA02. 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 ("CF") and chronic pulmonary P. aeruginosa infection. Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event profile similar to placebo. Pharmacokinetics findings confirm that AP-PA02 can be effectively delivered to the lungs through nebulization with minimal systemic exposure, with single ascending doses and multiple ascending doses resulting in a proportional increase in exposure as measured in induced sputum. AP-PA02 exposures were generally consistent across subjects. Additionally, bacterial levels of P. aeruginosa in the sputum measured at several timepoints suggest improvement in bacterial load reduction for subjects treated with AP-PA02 at the end of treatment as compared to placebo after ten days of dosing. In addition, a correlation was seen between increasing phage dose (higher AP-PA02 exposures) and reduction in the bacterial load, supporting the biologic plausibility of a bacterial specific mechanism of action and creating the opportunity for phage as a therapeutic alternative to inhaled antibiotics. 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, 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. aeruginosa.
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 "Tailwind" 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. aeruginosa infection. Data indicated that inhaled AP-PA02 provides a durable reduction of P. aeruginosa in the lung, with a favorable safety and tolerability profile. The Tailwind study was conducted in two cohorts running in parallel: 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. The primary efficacy endpoint was the reduction in P. aeruginosa colony forming units ("CFUs") in lung sputum at one week following completion of dosing (day 17) compared to baseline. Per the statistical analysis plan, efficacy analysis of each independent cohort showed no significant difference between subjects treated with AP-PA02 and placebo due to small numbers of subjects in each cohort. Notably, a post-hoc intent-to-treat analysis (n=33 active and n=15 placebo; all subjects from both cohorts) demonstrated a statistically significant reduction of P. aeruginosa CFUs in the lung at day 17 (AP-PA02 vs. placebo; P=0.05). The reduction in P. aeruginosa CFUs persisted two weeks following completion of dosing with AP-PA02 when compared with placebo at day 24 (AP-PA02 vs. placebo; P=0.015). Additionally, paired analysis of P. aeruginosa CFU density at baseline compared to day 10 (P=0.03), day 11 (P=0.01), day 17 (P=0.003) and day 24 (P=0.018) was significant in the AP-PA02-treated cohort. We believe the data suggest that AP-PA02 alone is as effective as the combination therapy of phage and antibiotics in reducing P. aeruginosa CFUs in the lung. Additionally, approximately one-third of subjects treated with phage monotherapy exhibited at least a 2-log CFU reduction in P. aeruginosa compared to no reduction in placebo treated subjects. Safety data indicate that inhaled AP-PA02 was well-tolerated with treatment-emergent adverse events mild and self-limiting. There was one possibly related serious adverse event that was linked to an acute pulmonary event requiring hospitalization that was responsive to antibiotics. We believe the safety and tolerability of AP-PA02 offers a promising profile for treating chronically infected NCFB patients.
Results from the Phase 2 Tailwind 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. The Phase 2 Tailwind 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 to evaluate inhaled AP-PA02 as an alternative to antibiotics in chronic pulmonary P. aeruginosa infection.
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. aeruginosa. 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.
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. aureus; this has enabled us to pursue treatment of complicated S. 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 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 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: TOC BAT; p = 0.020: EOS).
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.
Conclusions:
| ● | 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 2025TM. 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 aureusBacteremia," was accepted as a late-breaking oral presentation, and was presented by Dr. Loren G. 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. 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. aureus. 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.
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 (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.
S. 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. aureus. We had planned to initiate a Phase 1b/2a trial; however, in light of the growing concerns of both PJI and wound infections, we are considering revising the protocol to include both indications. 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. aureus.
The following chart summarizes the status of our phage product candidate development programs and partners.
We have incurred net losses since our inception and our operations to date have been primarily limited to research and development and raising capital. As of December 31, 2025, we had an accumulated deficit of $501.5 million. We currently expect to use our existing cash and cash equivalents for the focused research and development of our current product candidates and for working capital and other general corporate purposes. We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on completing the development of and seeking to obtain regulatory approval for our product candidates. We do not expect to generate product revenue unless and until we successfully complete development and obtain marketing approval for at least one of our product candidates. 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 $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. Accordingly, we will be required to obtain further funding through one or more other public or private equity offerings, debt financings, collaboration, strategic financing, grants or government contract awards, licensing arrangements or other sources. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and potential disruptions to, and volatility in, financial markets in the United States and worldwide. Adequate additional funding may not be available to us on acceptable terms, or at all. If we are unable to raise capital when needed or on acceptable terms, we may be required to defer, reduce or eliminate significant planned expenditures, restructure, curtail or eliminate some or all of our development programs or other operations, dispose of assets, enter into arrangements that may require us to relinquish rights to certain of our product candidates, technologies or potential markets, file for bankruptcy or cease operations altogether. Any of these events could have a material adverse effect on our business, financial condition and results of operations and result in a loss of investment by our stockholders.
Recent Events
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 Agreementwith 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 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 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 March 4, 2024, we entered into the 2024 Credit Agreement for the 2024 Loan in an aggregate amount of $35.0 million. The 2024 Loan bears interest at an annual rate of 14.0% and matures on June 1, 2027. Principal and accrued interest are payable at maturity. Repayment of the 2024 Loan is guaranteed by our domestic subsidiaries, and the loan is secured by substantially all of our assets and the subsidiary guarantors. Concurrently with the execution of the 2024 Credit Agreement, we amended certain provisions of the Convertible Loan and Convertible Credit Agreement and the 2023 Loan and 2023 Credit Agreement to, among other things, conform certain terms relating to permitted indebtedness and permitted liens.
Results of Operations
Comparison of years ended December 31, 2025 and 2024
The following table summarizesour results of operations for the years ended December 31, 2025 and 2024 (dollars in thousands):
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Year Ended December 31, |
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Change |
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2025 |
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2024 |
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Amount |
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% |
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Grant and award revenue |
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$ |
4,904 |
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$ |
5,174 |
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$ |
(270) |
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(5.2%) |
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Operating expenses |
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Research and development |
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23,717 |
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34,426 |
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(10,709) |
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(31.1%) |
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General and administrative |
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12,409 |
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|
13,184 |
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(775) |
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(5.9%) |
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Impairment expense |
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5,412 |
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- |
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5,412 |
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* |
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Total operating expenses |
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41,538 |
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47,610 |
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(6,072) |
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(12.8%) |
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Loss from operations |
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(36,634) |
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(42,436) |
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5,802 |
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(13.7%) |
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Other income (expense) |
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Interest income |
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388 |
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697 |
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(309) |
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(44.3%) |
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Interest expense |
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(16,590) |
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(10,742) |
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(5,848) |
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54.4% |
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Change in fair value of the Convertible Loan |
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(120,963) |
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31,399 |
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(152,362) |
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(485.2%) |
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Gain on debt and the Convertible Loan extinguishments |
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- |
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2,166 |
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(2,166) |
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(100.0%) |
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Total other income (expense), net |
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(137,165) |
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23,520 |
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(160,685) |
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(683.2%) |
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Net loss |
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$ |
(173,799) |
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$ |
(18,916) |
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$ |
(154,883) |
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818.8% |
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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
The following table summarizes our research and development expenses for the years ended December 31, 2025 and 2024 (dollars in thousands):
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Year Ended December 31, |
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Change |
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|
|
2025 |
|
2024 |
|
Amount |
|
% |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
External costs: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials |
|
$ |
2,022 |
|
$ |
10,278 |
|
$ |
(8,256) |
|
|
(80.3)% |
|
Other research and development costs, including consulting, laboratory supplies and other |
|
|
2,980 |
|
|
3,418 |
|
|
(438) |
|
|
(12.8%) |
|
Total external costs |
|
5,002 |
|
|
13,696 |
|
(8,694) |
|
|
(63.5%) |
||
|
Internal costs: |
|
|
|
|
|
|
|
|
|
|
||
|
Personnel-related costs |
|
|
9,199 |
|
|
10,925 |
|
|
(1,726) |
|
|
(15.8%) |
|
Facilities and overhead costs |
|
9,516 |
|
9,805 |
|
(289) |
|
(2.9%) |
||||
|
Total research and development expense: |
|
$ |
23,717 |
|
$ |
34,426 |
|
$ |
(10,709) |
|
(31.1%) |
|
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. 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):
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|||||
|
|
|
|
2025 |
|
2024 |
||
|
Product |
Project name |
|
|
|
|
||
|
AP-PA02 |
Non-Cystic Fibrosis Bronchiectasis |
|
$ |
114 |
|
$ |
6,840 |
|
AP-PA02 |
Cystic Fibrosis |
|
|
33 |
|
|
236 |
|
AP-SA02 |
Bacteremia |
|
|
2,157 |
|
|
4,177 |
|
AP-SA02 |
Prosthetic Joint Infection |
|
|
2 |
|
|
35 |
|
|
Expenses not allocated by projects |
|
|
2,696 |
|
|
2,408 |
|
|
Total external costs |
|
$ |
5,002 |
|
$ |
13,696 |
* Expenses not allocated by projects include consultants, lab supplies and outsource service expenses
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 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
Interest income for the years ended December 31, 2025 and 2024 was $0.4 million and $0.7 million, respectively, which was related to interest income earned on our cash, cash equivalents and restricted cash balances.
Interest Expense
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 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 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. The gain was estimated as the difference between the carrying value of the 2023 Loan and Convertible Loan before the modification and the fair value of the 2023 Loan and Convertible Loan after the modification. 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.
Liquidity, Capital Resources and Financial Condition
We have incurred net losses since our inception and have negative operating cash flows. Our cash and cash equivalents of $8.7 million as of December 31, 2025, will not be sufficient to fund our operations for the next 12 months from the date the consolidated financial statements included elsewhere in this Annual Report on Form 10-K are issued. We plan to control our expenses and to raise additional capital through a combination of public and private equity, debt financings, strategic alliances, and grant arrangements. These circumstances raise substantial doubt about our ability to continue as a going concern. While management believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt, these plans are not entirely within its control and cannot be assessed as being probable of occurring. We may not be able to secure additional financing in a timely manner or on favorable terms, if at all.
On January 23, 2026, we entered into amendments to the March 2025 Credit Agreement, the 2024 Credit Agreement, the 2023 Credit Agreementand 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 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.
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.
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 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 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. We will continue to recognize additional grant and award revenue until the full amount of the amended award is utilized.
Future Capital Requirements
We will need to raise additional capital in the future to continue to fund our operations. Our future funding requirements will depend on many factors, including:
| ● | the costs and timing of our research and development activities; |
| ● | the progress and cost of our clinical trials and other research and development activities; |
| ● | manufacturing costs associated with our targeted phage therapies strategy and other research and development activities; |
| ● | the costs and timing of seeking regulatory approvals; |
| ● | the costs of filing, prosecuting and enforcing any patent applications, claims, patents and other intellectual property rights; and |
| ● | the costs of potential lawsuits involving us or our product candidates. |
We may seek to raise capital through a variety of sources, including:
| ● | the public equity market; |
| ● | private equity or debt financings; |
| ● | collaborative arrangements, |
| ● | government grants; or |
| ● | strategic financings. |
Any additional fundraising efforts may divert our management team from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. Our ability to raise additional funds will depend, in part, on the success of our product development activities, including our targeted phage therapies strategy and any clinical trials we initiate, regulatory events, our ability to identify and enter into in-licensing or other strategic arrangements, and other events or conditions that may affect our value or prospects, as well as factors related to financial, economic and market conditions, many of which are beyond our control. We cannot be certain that sufficient funds will be available to us when required or on acceptable terms. If we are unable to secure additional funds on a timely basis or on acceptable terms, we may be required to defer, reduce or eliminate significant planned expenditures, restructure, curtail or eliminate some or all of our development programs or other operations, dispose of technology or assets, pursue an acquisition of our company by a third party at a price that may result in a loss on investment for our stockholders, enter into arrangements that may require us to relinquish rights to certain of our product candidates, technologies or potential markets, file for bankruptcy or cease operations altogether. Any of these events could have a material adverse effect on our business, financial condition and results of operations, increase the risk of insolvency and loss of investment by our stockholders. To the extent that additional capital is raised through the sale of equity or convertible loan securities, the issuance of such securities could result in dilution to our existing stockholders. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the United States and worldwide.
Cash Flows
The following table summarizes our sources and uses of cash for the periods presented (in thousands):
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
||||
|
|
2025 |
|
2024 |
|
||
|
Net cash provided by (used in): |
|
|
|
|
|
|
|
Operating activities |
$ |
(25,763) |
|
$ |
(37,551) |
|
|
Investing activities |
|
(542) |
|
|
(1,879) |
|
|
Financing activities |
|
25,612 |
|
|
34,958 |
|
|
Net change in cash, cash equivalents and restricted cash |
$ |
(693) |
|
$ |
(4,472) |
|
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 $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. 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 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.
Off-Balance Sheet Arrangements
As of December 31, 2025, we did not have any off-balance sheet arrangements.
Critical Accounting Policies and Use of Estimates
Management's discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements as of December 31, 2025 and December 31, 2024, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate estimates and assumptions, including but not limited to those related to the fair value estimate of the Convertible Loan, stock-based compensation expense, accruals for research and development costs, impairment of goodwill and intangible assets and impairment of long-lived assets. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Although our significant accounting policies are described in more detail in Note 3, "Significant Accounting Policies", to our consolidated financial statements included in this Annual Report on Form 10-K, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
Accrued Research and Development
All research and development costs are expensed as incurred. Research and development costs consist primarily of salaries, employee benefits, costs associated with preclinical studies and clinical trials (including amounts paid to clinical research organizations and other professional services) and in-process research and development expenses. Payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.
We record accruals for estimated research and development costs, comprising payments for work performed by third-party contractors, laboratories, participating clinical trial sites, and others. Some of these contractors bill monthly based on actual services performed, while others bill periodically based upon achieving certain contractual milestones. For the latter, we accrue the expenses as goods or services are used or rendered. Clinical trial site costs related to patient enrollment are accrued as patients enter and progress through the trial. 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. 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 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. Refer to Note 7, "Convertible Loan", in the consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional details.
We account for the Convertible Loan at fair value and changes in fair value are included in other income (expense) in the consolidated statements of operations in each reporting period. We estimate the fair value using a weighted probability of various settlement scenarios during the Convertible Loan term discounted to each reporting date. 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 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, 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
Refer to Note 3, "Significant Accounting Policies", of the notes to the consolidated financial statements contained elsewhere in this Annual Report on Form 10-K.