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])

On February 27, 2026 Bayer reported results from the ongoing global Phase I first-in-human, dose-escalation PAnTHa study (NCT06217822) evaluating the safety, tolerability and preliminary efficacy of 225Ac-PSMA-Trillium (BAY 3563254), a next-generation targeted alpha therapy (TAT) in patients with advanced metastatic castration-resistant prostate cancer (mCRPC). The dose for expansion was successfully identified, with ≥80% of patients achieving a PSA50 response at the expansion dose.

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New data were presented during the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium, taking place in San Francisco, CA, United States, from February 26-28, 2026. These clinical data represent the first disclosure for 225Ac-PSMA-Trillium and were selected as part of the rapid oral session focused on advanced prostate cancer research. They support advancing 225Ac-PSMA-Trillium to the next phase of clinical development. TAT is a strategic pillar of precision oncology at Bayer, with the potential to accelerate novel treatment options for patients with mCRPC.

"We are excited to see the results from the Phase I PAnTHa study demonstrating the potential of our next-generation targeted alpha therapy to provide new treatment options for patients with advanced metastatic castration-resistant prostate cancer (mCRPC), a type of cancer with limited treatment options and poor prognosis," said Dominik Ruettinger, M.D., Ph.D., Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division. "The development of 225Ac-PSMA-Trillium confirms our ongoing focus on prostate cancer treatment and continued drive to develop precise and personalized healthcare solutions."

"Despite progress, patients with metastatic castration-resistant prostate cancer continue to face high mortality, highlighting the urgent need for new precision therapies," said Fred Saad, MD, FRCS, Professor and Chairman of Surgery at the University of Montreal and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), Canada. "The promising data support the further investigation of this molecule to provide a potentially meaningful clinical benefit for patients with mCRPC."

225Ac-PSMA-Trillium (BAY 3563254) is a next-generation investigational TAT labeled with actinium-225 and comprising a novel PSMA (prostate-specific membrane antigen)-targeting small molecule with a customized albumin-binding moiety. The compound is designed specifically to increase uptake within the tumor, with the goal to provide a differentiated safety and efficacy profile.

Prostate cancer is the second most commonly diagnosed cancer in men with less than three years median survival among metastatic patients, who have developed castration-resistance. There is an increasing unmet need to improve the outcomes of men with mCRPC.6

About the PAnTHa study (NCT06217822)
PSMA-targeted Actinium-225-Trillium FiH study in Advanced mCRPC (PAnTHa), is a Phase I, open-label, first-in-human, multicenter study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of 225Ac-PSMA-Trillium (BAY 3563254) in participants with advanced metastatic castration resistant prostate cancer (mCRPC) that have at least 1 PSMA-positive lesion on PSMA-PET. In the trial, patients received 225Ac-PSMA-Trillium intravenously every 6 weeks for up to 4 doses. At data cut-off, 50 patients were enrolled across four dose levels in the escalation cohort and 80% completed all four cycles of 225Ac-PSMA-Trillium (range: 75 to 150 kBq/kg; 12-13 patients/cohort).

Detailed Results from PAnTHa
To date, 225Ac-PSMA-Trillium has had no dose-limiting toxicities (DLTs) or treatment-related deaths. Most common treatment-emergent adverse events (TEAEs) were dry mouth, fatigue and nausea. Overall, 38% of patients had Gr ≥3 TEAEs, most commonly lymphopenia, 16% of patients had serious TEAEs and 4% of patients discontinued treatment due to TEAEs. The overall response rate per PCWG3 criteria across all doses in patients with measurable disease at baseline (n=24) was 46%, with disease control rate of 83%. Respective PSA50 and PSA90 response rates were 58% and 36% overall, and 83% and 58% at the Recommended Dose for Expansion (RDE). This was further supported by the decline in circulating tumor DNA (ctDNA) fraction at the RDE. Further, PSA50 responses were observed across all baseline mean Standardized Uptake Value (SUVmean) groups.

About 225Ac-PSMA-Trillium (BAY 3563254)
225Ac-PSMA-Trillium (BAY 3563254) is a next-generation TAT that comprises a highly specific PSMA-targeting motif, an albumin-binding domain to optimize tumor uptake and retention, and a MacropaTM chelator complexed with the alpha-emitter actinium-225. The distinctive structural components are designed to provide a differentiated safety and efficacy profile. Both in vitro and in vivo characterization of 225Ac-PSMA-Trillium demonstrates high tumor uptake and retention. Potent antitumor efficacy has been observed in several preclinical models of prostate cancer. PSMA-Trillium resulted from the acquisition of PSMA Therapeutics and Noria Therapeutics in 2021 and are now under clinical investigation.

About Targeted Alpha Therapy
Targeted alpha therapy (TAT) is an emerging class of radionuclide therapy that can be used against a variety of tumors. It delivers alpha particle radiation directly to the tumor inside the body, either via its bone-seeking property (radium-223) or by combining alpha radionuclides, such as actinium-225, with specific targeting moieties.

Actinium-225 is an alpha particle–emitting radionuclide with a 9.9-day half-life. Alpha particles deposit highly ionizing radiation over a short range. This localized delivery of the radioactive payload induces irreparable DNA double-strand breaks, often resulting in cell death.

About prostate cancer
Prostate cancer is the second most commonly diagnosed cancer in men. Despite significant advances in the last decade, the prognosis for men with mCRPC remains poor with a median survival of about 31 months.2 With increasing incidence, more than 300 thousand prostate cancer cases were reported in the US in 2025; 5-year relative survival with distant disease is only 34%.3 Advances in imaging technologies (i.e. PSMA-PET) and their utilization across all stages of prostate cancer will likely result in an increased number of patients diagnosed with metastatic disease earlier. Consequently, more men will be diagnosed with de novo PSMA-positive metastatic disease.

(Press release, Bayer, FEB 27, 2026, View Source [SID1234663138])

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 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported it will present new data in genitourinary malignancies at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026.

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Across four oral presentations in muscle-invasive bladder cancer (MIBC), these data reinforce Signatera’s role in identifying patients who benefit from adjuvant immunotherapy, supporting response-adaptive bladder preservation strategies, and refining molecular residual disease (MRD) detection with plasma circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA).

Bladder Preservation: INDIBLADE and RETAIN

The INDIBLADE and RETAIN multicenter phase 2 trials demonstrate Signatera’s consistent performance in treatment response monitoring across diverse neoadjuvant regimens in MIBC, with 73-77% of patients demonstrating clearance of ctDNA following therapy and Signatera-negativity showing strong associations with positive outcomes, even with the bladder preserved.

INDIBLADE, the findings of which will be published today in Nature Medicine, investigated induction with combination immune checkpoint inhibitors (ICI) followed by chemoradiotherapy as a bladder-sparing strategy in stage II/III MIBC patients. The results show that Signatera status post-ICI was associated with bladder-intact event-free survival (BI-EFS). Specifically, Signatera-negativity at baseline and post-neoadjuvant therapy was linked to an 88.6% and 91% estimated two-year BI-EFS, respectively.

RETAIN evaluated a clinical response-adapted approach to identify patients for potential bladder-preservation following neoadjuvant therapy. The findings showed that post-treatment ctDNA clearance or negativity was associated with improved metastasis-free survival (MFS), and that Signatera-negative patients with no clinical or radiographic evidence of disease managed with active surveillance achieved MFS comparable to Signatera-negative patients undergoing cystectomy. In contrast, persistent Signatera-positivity was associated with poor outcomes.

Perioperative Care: NIAGARA

This phase 3 randomized perioperative study includes the first-ever presentation of utDNA data with clinical correlation. The combination of utDNA and ctDNA status post-neoadjuvant therapy and pre-cystectomy identified the group with the highest 24-month EFS. utDNA-positivity pre-cystectomy was more strongly associated with residual non-invasive disease vs ctDNA-positivity was more strongly associated with residual invasive disease. These data suggest that the combined assessment of utDNA and ctDNA can provide complementary risk stratification benchmarked against pathologic staging, enabling comprehensive identification of residual disease.

"As treatment options expand in perioperative and bladder preservation settings, we need tools that help us determine who truly requires additional therapy and who may safely avoid it," said Michiel van der Heijden, M.D., Ph.D., Netherlands Cancer Institute, principal investigator of INDIBLADE and presenting author of the NIAGARA study. "The data presented at ASCO (Free ASCO Whitepaper) GU demonstrate that MRD assessment with Signatera has strong correlations with outcomes and the potential to inform these critical treatment decisions."

"Following our milestone PMA submission to the FDA based on IMvigor011, these compelling data presentations reflect our commitment to transforming care across the spectrum of genitourinary malignancies," said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. "The new data suggests a particularly important opportunity for Signatera to optimize clinical decisions around bladder preservation, a major opening to improve patient quality of life."

The full list of presentations at ASCO (Free ASCO Whitepaper) GU includes:

February 27, 8:10 AM PT | Abstract #633 (Oral Presentation)
Presenter: Joaquim Bellmunt, M.D.
Circulating tumor (ct)DNA-guided adjuvant atezolizumab (atezo) in muscle-invasive bladder cancer (MIBC): Exploratory analysis of ctDNA dynamics in the IMvigor011 trial

February 27, 8:10 AM PT | Abstract #632 (Oral Presentation)
Presenter: Pooja Ghatalia, M.D.
Circulating tumor DNA (ctDNA) to guide response-adapted bladder preservation in muscle invasive bladder cancer (MIBC): Integrated analysis of the RETAIN trials

February 27, 11:30 AM PT | Abstract #797
Presenter: Can Aydogdu, M.D.
Integrating genomic profiling and circulating tumor DNA monitoring to optimize surveillance strategies in muscle-invasive bladder cancer

February 27, 11:30 AM PT | Abstract #831
Presenter: Can Aydogdu, M.D.
Association of ctDNA status with upstaging, pathologic outcomes, and genomic alterations in high-risk NMIBC

February 27, 2:30 PM PT | Abstract #637 (Oral Presentation)
Presenter: Jan-Jaap J. Mellema, M.D.
Induction ipilimumab plus nivolumab followed by consolidating chemoradiotherapy as bladder-sparing treatment in stage II/III urothelial carcinoma of the bladder: The phase 2 INDIBLADE trial

February 27, 4:00 PM PT | Abstract #636 (Oral Presentation)
Presenter: Michiel van der Heijden, M.D., Ph.D.
Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA

February 28, 7:00 AM PT | Abstract #532
Presenter: Shuchi Gulati, M.D., M.Sc.
Association of pre-operative circulating tumor DNA (ctDNA) status with clinicopathologic characteristics in patients (pts) with localized renal cell carcinoma (RCC)

February 28, 7:00 AM PT | Abstract #620
Presenter: Dalia Kaakour, M.D., MPH
Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer

February 27, 11:30 AM PT | Abstract #860
Presenter: Lingbin Meng, M.D., Ph.D.
Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer

February 27, 11:30 AM PT | Abstract #800
Presenter: Tanya Jindal, BS, BA
Predictive value of early circulating tumor DNA (ctDNA) response in advanced urothelial carcinoma (aUC) treated with enfortumab vedotin plus pembrolizumab (EVP).

February 28, 7:00 AM PT | Abstract #541
Presenter: David F. McDermott, M.D.
Circulating tumor DNA (ctDNA) analysis in participants (pts) with advanced clear cell renal cell carcinoma (ccRCC) treated with first-line pembrolizumab (pembro) monotherapy from the phase 2 KEYNOTE-427 study.

(Press release, Natera, FEB 27, 2026, View Source [SID1234663139])

On February 26, 2026 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) reported that SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), reported positive topline results from a pre-specified interim analysis of a Phase III study (BL-B01D1-307) evaluating izalontamab brengitecan (iza-bren), an EGFR×HER3 bispecific antibody-drug conjugate (ADC), in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose disease progressed following prior taxane therapy.

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In the pre-specified interim analysis, topline results showed that iza-bren demonstrated statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy of physician’s choice, meeting both dual primary endpoints.

This Phase III study represents the third Phase III trial in which iza-bren has achieved its primary endpoint(s). It is the first bispecific ADC in a Phase III study to report dual positive PFS/OS results in the treatment of triple-negative breast cancer.

"Patients with advanced triple-negative breast cancer who progress after standard therapies face an urgent need for more effective options," said Dr. Yi Zhu, Chief Executive Officer of Biokin "These topline results further strengthen our confidence in iza-bren’s potential to deliver meaningful clinical benefit across multiple cancers."

"These results underscore the potential of bispecific ADC technology targeting both EGFR and HER3 to meaningfully change outcomes in difficult‑to‑treat cancers," said Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb. "We look forward to advancing the science and development of ADCs, with the hope of uncovering new options for people living with cancer."

These data will be presented at an upcoming medical meeting.

The BL-B01D1-307 study is sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), in Mainland China. Outside of China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb (BMS) under a collaboration and exclusive license agreement.

The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation (BTD) to iza-bren for the treatment of seven indications, and the U.S. FDA has granted BTD to iza-bren for previously treated NSCLC patients with an EGFR mutation. The New Drug Applications (NDAs) for two indications of iza-bren, for the treatment of locally advanced or metastatic nasopharyngeal carcinoma and for the treatment of recurrent or metastatic esophageal squamous cell carcinoma, have been accepted by the CDE and included in the priority review process.

About BL-B01D1-307
BL-B01D1-307 is a Phase III, randomized, open-label, multi-center clinical study in China, evaluating iza-bren in patients with unresectable locally advanced or metastatic triple-negative breast cancer whose disease progressed following prior taxane therapy. The study includes dual primary endpoints of progression-free survival (PFS) and overall survival (OS). For more detailed information, please visit clinical.trials.gov (NCT06382142).

About iza-bren
SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death.

(Press release, Bristol-Myers Squibb, FEB 26, 2026, View Source [SID1234663061])