On February 27, 2026 MonTa Biosciences, a Copenhagen-based clinical-stage biotech company developing next-generation innate immune modulators for cancer therapy, reported the expansion of its clinical program with MBS8, a systemically administered second-generation TLR7 agonist, in checkpoint-resistant cutaneous melanoma and metastatic uveal melanoma.

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Unlike first-generation systemic TLR7 approaches that were limited by toxicity, MBS8 utilizes a proprietary lipid micelle formulation designed to enable controlled innate immune activation while maintaining systemic tolerability. Phase I evaluation established a favorable safety profile, encouraging tumor effects and a recommended dose for further development

The multi-center expansion study will enroll patients in Denmark and Spain. MBS8 will be evaluated in combination with pembrolizumab (Keytruda) in patients with acquired resistance to PD-1 therapy, and as monotherapy in uveal melanoma patients previously treated with T-cell engagers.

CEO Statement
"We are very encouraged by the MBS8 phase I data generated and believe systemic TLR7 agonism is entering a new era of clinical validation and investment momentum," said Simon Skjøde Jensen, CEO of MonTa Biosciences. "With Phase I safety established, we are advancing MBS8, which we believe has Best-in-class potential, into defined resistant melanoma populations where innate immune activation may restore responsiveness to immunotherapy. As capital and clinical momentum accelerate in the TLR7 field, we see a clear opportunity to differentiate through safety, formulation, and rational combination strategies."

Addressing Checkpoint Resistance
Although immune checkpoint inhibitors have transformed melanoma treatment, up to 40–50% of responding patients ultimately relapse—representing approximately 10-12,000 patients annually across the US and EU—with no broadly effective therapy specifically targeting acquired resistance.

Orphan Opportunity in Metastatic Uveal Melanoma
Metastatic uveal melanoma remains a major unmet need, with approximately 4,000 new cases annually in the US and Europe. The indication qualifies for orphan designation, offering potential regulatory incentives and accelerated development pathways. Checkpoint inhibitors show response rates below 10%, and while a T-cell engager is approved for a subset of patients, durable responses remain limited.

TLR7 Agonism Gains Clinical Validation and Reduces Development Risk
Systemic TLR7 agonism is rapidly re-emerging as a validated immuno-oncology strategy, supported by substantial capital deployment and advancing clinical data. Eikon Therapeutics has raised more than USD 1 billion to advance its TLR7 agonist EIK1001 into Phase II/III development and completed its NASDAQ listing in February 2026. Interim Phase II data in NSCLC demonstrated improved progression-free survival when EIK1001 was combined with chemotherapy and pembrolizumab, reinforcing the clinical relevance of systemic innate immune activation.

In parallel, a landmark Nature publication (Grippin et al., 2025) showed that NSCLC and melanoma patients receiving an mRNA COVID-19 vaccine—known to partly activate TLR7 signaling—within 100 days of initiating checkpoint therapy experienced significantly improved survival, including nearly doubled 36-month overall survival in NSCLC.
Collectively, these developments materially reduce development and clinical risk for MBS8 and underscore its potential to enhance checkpoint efficacy.

MonTa’s MBS8 is, alongside EIK1001, among the most advanced systemically administered TLR7 agonists with completed Phase I safety data, positioning the company at the forefront of this revalidated therapeutic class.

(Press release, MonTa Biosciences, FEB 27, 2026, View Source [SID1234663126])

On February 27, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported results from the final analysis of the pivotal Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, showing that KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab significantly improved overall survival (OS), a key secondary endpoint, for patients with platinum-resistant recurrent ovarian cancer regardless of PD-L1 status versus paclitaxel with or without bevacizumab alone, the most active standard of care control arm for patients who are bevacizumab-eligible. These data will be presented for the first time today during a Best Oral Session at the European Society of Gynaecological Oncology (ESGO) 2026 Congress (abstract #526).

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As previously reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, KEYTRUDA plus paclitaxel with or without bevacizumab met its primary endpoint of progression-free survival (PFS) in the all comers population of patients with platinum-resistant recurrent ovarian cancer, as well as in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). The KEYTRUDA regimen also met its key secondary endpoint of OS in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1).

At the final analysis, after a median follow-up of 32.7 months (range, 26.1-44.1), KEYTRUDA plus paclitaxel with or without bevacizumab demonstrated a statistically significant and clinically meaningful improvement in OS in all comers, reducing the risk of death by 18% (HR=0.82 [95% CI, 0.69-0.97]; p=0.0115) compared to paclitaxel with or without bevacizumab alone. For patients who received the KEYTRUDA regimen, median OS was 17.7 months versus 14.0 months for patients receiving the placebo regimen. The observed OS is among the longest reported in any clinical trial for platinum-resistant recurrent ovarian cancer, showing a clinically meaningful benefit of this regimen relative to the most active standard of care control arm, weekly paclitaxel with bevacizumab in bevacizumab-eligible patients.

"Patients with platinum-resistant ovarian cancer show reduced responses to traditional treatment regimens and may experience poor overall survival," said Dr. Nicoletta Colombo, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. "These results build on prior data from the KEYNOTE-B96 trial and further define the clinical impact of this pembrolizumab-based regimen in appropriate patients with platinum-resistant recurrent ovarian cancer."

Additionally, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA in combination with paclitaxel with or without bevacizumab for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 (CPS ≥1), and who have received one or two prior systemic treatment regimens.

In February, KEYTRUDA plus paclitaxel with or without bevacizumab was approved by the U.S. Food and Drug Administration (FDA) to treat adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens based on previous data from the KEYNOTE-B96 trial.

"Results from the final analysis of KEYNOTE-B96, including overall survival data in the all comers population, demonstrate the continued clinical benefit of KEYTRUDA plus paclitaxel with or without bevacizumab for certain patients with platinum-resistant recurrent ovarian cancer," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "Taken together, the recent FDA approval and CHMP positive opinion underscore our commitment to the ovarian cancer community and our ongoing focus on delivering therapies that can help patients with unmet needs across women’s cancers."

Study design and additional data from KEYNOTE-B96/ENGOT-ov65
KEYNOTE-B96, also known as ENGOT-ov65, is a multicenter, randomized, double-blind placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT05116189) sponsored by Merck and conducted in collaboration with the European Network for Gynecologic Oncology Trial (ENGOT) groups investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab compared to placebo plus paclitaxel with or without bevacizumab for the treatment of platinum-resistant recurrent ovarian cancer. The primary endpoint is PFS, as assessed by investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS is a key secondary endpoint. The trial enrolled 643 patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma, regardless of PD-L1 tumor expression status, who received one or two prior lines of systemic therapy for ovarian carcinoma, including at least one line of platinum-based chemotherapy. Of the 643 enrolled patients, 72% of patients had tumors expressing PD-L1 (CPS ≥1). Patients were enrolled in KEYNOTE-B96 regardless of PD-L1 tumor expression status. Patients were randomized (1:1) to receive either KEYTRUDA plus paclitaxel with or without bevacizumab, or placebo plus paclitaxel with or without bevacizumab. KEYTRUDA (400 mg) or placebo were administered on Day 1 of each six-week treatment cycle and paclitaxel (80 mg/m2) was administered on Days 1, 8 and 15 of each three-week treatment cycle. The option to use bevacizumab was by investigator choice prior to randomization. Bevacizumab (10 mg/kg) was administered on Day 1 of a two-week treatment cycle.

At the final analysis, in the all comers population, KEYTRUDA plus paclitaxel with or without bevacizumab reduced the risk of disease progression or death by 27% (HR=0.73 [95% CI, 0.62-0.87]) compared to paclitaxel with or without bevacizumab alone. In patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1), the KEYTRUDA regimen reduced the risk of disease progression or death by 24% (HR=0.76 [95% CI, 0.62-0.93]) versus paclitaxel with or without bevacizumab alone. The KEYTRUDA regimen also continued to demonstrate a clinically meaningful improvement in OS, a key secondary endpoint of the study, in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1), reducing the risk of death by 24% (HR=0.76 [95% CI, 0.62-0.93]) compared to paclitaxel with or without bevacizumab.

The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety concerns were identified. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 67.8% of patients receiving the KEYTRUDA regimen (n=320) versus 55.3% of patients receiving the placebo regimen (n=318). TRAEs led to death in 1.3% of patients receiving the KEYTRUDA regimen and 1.6% of patients receiving the placebo regimen.

Immune-mediated adverse events (AEs) and infusion reactions of any grade occurred in 39.4% of patients receiving the KEYTRUDA regimen and 18.9% of patients receiving the placebo regimen. The most common of these events (occurring in ≥10% of patients) was hypothyroidism (18.1%) in patients receiving the KEYTRUDA regimen. Immune-mediated AEs led to death in 0.6% of patients in the KEYTRUDA arm and in no patients in the placebo arm.

About platinum-resistant ovarian cancer
Ovarian cancer often begins in the fallopian tubes or the ovaries. As of 2022, it is the eighth most commonly diagnosed cancer and the eighth leading cause of cancer death among women worldwide. Globally, there were more than 324,000 patients diagnosed with ovarian cancer and almost 207,000 deaths from the disease in 2022. In many regions, its incidence has been increasing, with estimates projecting a 42% increase in new cases worldwide by 2040. Over 80% of patients diagnosed with ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. Of these patients, approximately 25% will experience disease progression within six months of completing first-line platinum-based chemotherapy – defined as primary platinum-resistant ovarian cancer. Prognosis is particularly poor for these patients and approved treatment options are limited.

(Press release, Merck & Co, FEB 27, 2026, View Source [SID1234663125])

On February 27, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported results from the final analysis of the pivotal Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, showing that KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab significantly improved overall survival (OS), a key secondary endpoint, for patients with platinum-resistant recurrent ovarian cancer regardless of PD-L1 status versus paclitaxel with or without bevacizumab alone, the most active standard of care control arm for patients who are bevacizumab-eligible. These data will be presented for the first time today during a Best Oral Session at the European Society of Gynaecological Oncology (ESGO) 2026 Congress (abstract #526).

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As previously reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, KEYTRUDA plus paclitaxel with or without bevacizumab met its primary endpoint of progression-free survival (PFS) in the all comers population of patients with platinum-resistant recurrent ovarian cancer, as well as in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). The KEYTRUDA regimen also met its key secondary endpoint of OS in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1).

At the final analysis, after a median follow-up of 32.7 months (range, 26.1-44.1), KEYTRUDA plus paclitaxel with or without bevacizumab demonstrated a statistically significant and clinically meaningful improvement in OS in all comers, reducing the risk of death by 18% (HR=0.82 [95% CI, 0.69-0.97]; p=0.0115) compared to paclitaxel with or without bevacizumab alone. For patients who received the KEYTRUDA regimen, median OS was 17.7 months versus 14.0 months for patients receiving the placebo regimen. The observed OS is among the longest reported in any clinical trial for platinum-resistant recurrent ovarian cancer, showing a clinically meaningful benefit of this regimen relative to the most active standard of care control arm, weekly paclitaxel with bevacizumab in bevacizumab-eligible patients.

"Patients with platinum-resistant ovarian cancer show reduced responses to traditional treatment regimens and may experience poor overall survival," said Dr. Nicoletta Colombo, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. "These results build on prior data from the KEYNOTE-B96 trial and further define the clinical impact of this pembrolizumab-based regimen in appropriate patients with platinum-resistant recurrent ovarian cancer."

Additionally, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA in combination with paclitaxel with or without bevacizumab for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 (CPS ≥1), and who have received one or two prior systemic treatment regimens.

In February, KEYTRUDA plus paclitaxel with or without bevacizumab was approved by the U.S. Food and Drug Administration (FDA) to treat adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens based on previous data from the KEYNOTE-B96 trial.

"Results from the final analysis of KEYNOTE-B96, including overall survival data in the all comers population, demonstrate the continued clinical benefit of KEYTRUDA plus paclitaxel with or without bevacizumab for certain patients with platinum-resistant recurrent ovarian cancer," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "Taken together, the recent FDA approval and CHMP positive opinion underscore our commitment to the ovarian cancer community and our ongoing focus on delivering therapies that can help patients with unmet needs across women’s cancers."

Study design and additional data from KEYNOTE-B96/ENGOT-ov65
KEYNOTE-B96, also known as ENGOT-ov65, is a multicenter, randomized, double-blind placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT05116189) sponsored by Merck and conducted in collaboration with the European Network for Gynecologic Oncology Trial (ENGOT) groups investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab compared to placebo plus paclitaxel with or without bevacizumab for the treatment of platinum-resistant recurrent ovarian cancer. The primary endpoint is PFS, as assessed by investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS is a key secondary endpoint. The trial enrolled 643 patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma, regardless of PD-L1 tumor expression status, who received one or two prior lines of systemic therapy for ovarian carcinoma, including at least one line of platinum-based chemotherapy. Of the 643 enrolled patients, 72% of patients had tumors expressing PD-L1 (CPS ≥1). Patients were enrolled in KEYNOTE-B96 regardless of PD-L1 tumor expression status. Patients were randomized (1:1) to receive either KEYTRUDA plus paclitaxel with or without bevacizumab, or placebo plus paclitaxel with or without bevacizumab. KEYTRUDA (400 mg) or placebo were administered on Day 1 of each six-week treatment cycle and paclitaxel (80 mg/m2) was administered on Days 1, 8 and 15 of each three-week treatment cycle. The option to use bevacizumab was by investigator choice prior to randomization. Bevacizumab (10 mg/kg) was administered on Day 1 of a two-week treatment cycle.

At the final analysis, in the all comers population, KEYTRUDA plus paclitaxel with or without bevacizumab reduced the risk of disease progression or death by 27% (HR=0.73 [95% CI, 0.62-0.87]) compared to paclitaxel with or without bevacizumab alone. In patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1), the KEYTRUDA regimen reduced the risk of disease progression or death by 24% (HR=0.76 [95% CI, 0.62-0.93]) versus paclitaxel with or without bevacizumab alone. The KEYTRUDA regimen also continued to demonstrate a clinically meaningful improvement in OS, a key secondary endpoint of the study, in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1), reducing the risk of death by 24% (HR=0.76 [95% CI, 0.62-0.93]) compared to paclitaxel with or without bevacizumab.

The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety concerns were identified. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 67.8% of patients receiving the KEYTRUDA regimen (n=320) versus 55.3% of patients receiving the placebo regimen (n=318). TRAEs led to death in 1.3% of patients receiving the KEYTRUDA regimen and 1.6% of patients receiving the placebo regimen.

Immune-mediated adverse events (AEs) and infusion reactions of any grade occurred in 39.4% of patients receiving the KEYTRUDA regimen and 18.9% of patients receiving the placebo regimen. The most common of these events (occurring in ≥10% of patients) was hypothyroidism (18.1%) in patients receiving the KEYTRUDA regimen. Immune-mediated AEs led to death in 0.6% of patients in the KEYTRUDA arm and in no patients in the placebo arm.

About platinum-resistant ovarian cancer
Ovarian cancer often begins in the fallopian tubes or the ovaries. As of 2022, it is the eighth most commonly diagnosed cancer and the eighth leading cause of cancer death among women worldwide. Globally, there were more than 324,000 patients diagnosed with ovarian cancer and almost 207,000 deaths from the disease in 2022. In many regions, its incidence has been increasing, with estimates projecting a 42% increase in new cases worldwide by 2040. Over 80% of patients diagnosed with ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. Of these patients, approximately 25% will experience disease progression within six months of completing first-line platinum-based chemotherapy – defined as primary platinum-resistant ovarian cancer. Prognosis is particularly poor for these patients and approved treatment options are limited.

(Press release, Merck & Co, FEB 27, 2026, View Source [SID1234663124])

On February 27, 2026 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported that Company management will participate in the following investor conferences:

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TD Cowen 46th Annual Health Care Conference
Date and Time: Tuesday, March 3rd, 2026, at 3:10PM ET
Leerink Global Healthcare Conference
Date and Time: Monday, March 9th, 2026, at 8:00AM ET
Barclays 28th Annual Global Healthcare Conference
Date and Time: Tuesday, March 10th, 2026, at 1:00PM ET

Live webcasts for each of the conferences will be available on Certara’s investor relations website at View Source and will be available for replay for at least 90 days thereafter.

(Press release, Certara, FEB 27, 2026, View Source [SID1234663122])

On February 27, 2026 Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the full year ended December 31, 2025, and provided a business update.

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FY 2025 and Recent Business Highlights

Initiated Phase 1/2 Trial for ATR-04 program targeting oncology patients with EGFRi-associated rash; presented ATR-04 trial design and update at ASCO (Free ASCO Whitepaper) 2025
Announced positive preclinical data for ATR-01 program, targeting the treatment of ichthyosis vulgaris
Reported promising safety data from Phase 1b Trial of ATR12 in Netherton Syndrome
Completed financings of $8.5 million through private placements, follow-on financings and utilization of an equity line of credit.
"2025 was an exciting year for Azitra as we continued our work to revolutionize the treatment of dermatological diseases with our pipeline of first-in-class, engineered products delivered using topical live biotherapeutics," said Francisco Salva, CEO of Azitra. "A key highlight in 2025 was the progress made in our Phase 1/2 trial for ATR-04 targeting oncology patients with EGFRi-associated rash and the dosing of the trial’s first patient. We were thrilled to have the opportunity to present this technology and the trial design to leaders in the field at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, where we received positive feedback and encouraging interest."

"ATR-04 has previously been granted Fast Track designation from the FDA, signaling the potential for this candidate to help the approximately 150,000 people in the United States annually who are impacted by major dermatologic toxicities associated with EGFR inhibitor treatments. Though an impactful treatment for various serious cancers, EGFR inhibition can result in adverse skin reactions that can make it difficult for patients to stay on these effective therapies."

Mr. Salva added: "For our lead program, ATR-12, we continue to be encouraged by the promising safety data generated thus far in our Phase 1b trial and are optimistic that this candidate has the potential to be a life-changing innovation for people with Netherton syndrome, a rare, autosomal recessive disease, a chronic condition characterized by severe inflammation, pruritus, scaling, red, and dehydrated skin with no known cure and limited treatment options."

Mr. Salva continued: "Also in 2025, we presented positive preclinical data for our ATR-01 program targeting ichthyosis vulgaris. Impacting approximately 1.3 million in the United States with no treatment options beyond symptom management, ichthyosis vulgaris, is an autosomal semidominant genetic disorder caused by missing or abnormal filaggrin levels. The condition is characterized by generalized xerosis and fine, white to gray scales that are prominent on the abdomen, chest, and extensor surfaces of the extremities."

Mr. Salva concluded: "2026 promises to be an important year for Azitra with several anticipated milestones including topline data for both our Phase 1b study in Netherton Syndrome and the Phase 1/2 study in EGFRi-associated rash. We also look forward to completing IND-enabling studies for ATR-01. We remain excited and optimistic as we work towards these key events, which we believe can help build significant value for our shareholders in 2026, while we progress innovative and potentially transformative treatments for patients with severe and life-altering dermatological conditions."

Pipeline Achievements and Upcoming Milestones

ATR-12 – Advancing Phase 1b Clinical Trial in Netherton Syndrome

In June 2025, Azitra reported promising safety data with 50% of patients enrolled.
ATR12-351, a live precision dermatology therapeutic candidate has been generally safe and well-tolerated with occasional, transient, mild to moderate symptoms at application site to date.
Topline data from the Phase 1b trial is anticipated H2 2026.
ATR-04 – Addressing an Unmet Need for Cancer Patients in a Multi-billion Dollar Market Opportunity

Dosed first patient in Phase 1/2 Trial for ATR-04 program targeting oncology patients with EGFRi-associated rash in Q3 2025.
Topline data from first cohort of Phase 1/2 trial expected around mid-2026.
ATR-01 – Targeting Ichthyosis Vulgaris Which Impacts 1.3 million in the United States

Announced positive preclinical data for ATR-01 program in Q3 2025, demonstrating delivery of active, functional filaggrin through human stratum corneum and repair of damaged model skin
IND-enabling studies continue in 2026.
Financial Results for the Year Ended December 31, 2025

Research and Development (R&D) expenses: R&D expenses for the year ended December 31, 2025, were $4.8 million compared to $4.7 million for the fiscal year 2024.

General and Administrative (G&A) expenses: G&A expenses for the year ended December 31, 2025, were $6.2 million compared to $6.3 million for the fiscal year 2024.

Net Loss was $11.0 million for the year ended December 31, 2025, compared to $9.0 million for the fiscal year 2024.

Cash and cash equivalents: As of December 31, 2025, Azitra had cash and cash equivalents of $2.1 million.

(Press release, Azitra, FEB 27, 2026, View Source [SID1234663121])