Azitra Announces Pricing of Private Placement Financing of up to Approximately $10.5 Million with up to an Additional Approximately $20.9 Million

On March 19, 2026 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported that it has entered into a securities purchase agreement (the "SPA") with new and existing healthcare focused institutional investors. The financing is for gross proceeds of up to approximately $31.4 million to the Company, including initial gross proceeds of approximately $10.5 million and up to an additional $20.9 million in gross proceeds upon the potential cash exercise of accompanying warrants at the election of the investors. The transaction is expected to close on or about March 20, 2026, subject to the satisfaction of customary closing conditions.

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Participating investors include institutional healthcare focused funds, Stonepine Capital and Nantahala Capital as well as other institutional funds and individual healthcare professionals, along with certain Company insiders, including the Company’s Chief Executive Officer.

The financing enables Azitra to utilize its expertise in skin science and leverage its microbial genetic engineering platform to produce high value proteins and peptides for the cosmetic market. The market for biotech oriented cosmetic ingredients reached $2.3 billion in 2024 and is projected to grow to $3.7 billion by 20301. The new initiatives drive near term value creation opportunities by streamlining the time to commercialization and opening up a new universe of new potential strategic partners.

"Azitra is thrilled to be accelerating its new program focused on developing its proprietary filaggrin protein and peptide technologies for the consumer, cosmeceutical market," said Chief Executive Officer, Francisco Salva. "We are confident these technologies offer an exciting new way to address the appearance of fine lines and wrinkles as well as dry sensitive skin and eczema-like rashes. Over the last two decades, research has evolved to understand that such issues are not just the result of immune system overdrive but are commonly driven by a physical barrier deficiency caused by a lack of sufficient filaggrin protein and subsequent breakdown into peptides and natural moisturizing factors."

Pursuant to the terms of the SPA, the Company is selling to investors in the financing an aggregate of (i) 10,470 shares of Series A convertible non-redeemable preferred stock (the "Series A Preferred Stock"), (ii) Series B warrants (the "Series B Warrants") to purchase up to 85,101,201 shares of the Company’s common stock, par value $0.0001 ("Common Stock") and (iii) Series C warrants (the "Series C Warrants") to purchase up to 85,101,201 shares of Common Stock, (the Series B Warrants together with the Series C Warrants, the "Warrants"). Each share of Series A Preferred Stock is being sold together with a Series B Warrant to purchase 8,129 shares of Common Stock and a Series C Warrant to purchase 8,129 shares of Common Stock. The Series A Preferred Stock was sold at a purchase price of $1,000 per share to the investors. The Warrants will each have an exercise price of $0.123 per share, subject to adjustment in certain circumstances. In accordance with the terms of the Warrants, in certain circumstances, pre-funded warrants to purchase shares of Common Stock may be issued upon exercise of the Warrants (the "Pre-Funded Warrants").

Each share of Series A Preferred Stock will automatically convert into approximately 8,129 shares of Common Stock upon the approval of the Company’s stockholders and subject to certain beneficial ownership limitations set by each holder. Holders will receive Pre-Funded Warrants in lieu of shares of Common Stock upon conversion of the Series A Preferred Stock to avoid going above the beneficial ownership limitation. The Warrants will be exercisable following the receipt of approval by the Company’s stockholders. The Series B Warrants will terminate 18 months following the date of stockholder approval. The Series C Warrants will terminate, subject to certain exceptions, upon the 30th calendar day following the date on which the Company publicly announces data from its planned human cosmetic study testing the effect of the filaggrin technology.

The issuance of the securities is being made pursuant to exemptions from the registration requirements of the federal and state securities laws. Pursuant to the transaction documents, the Company must register the resale of the shares of common stock issuable upon conversion of the Series A Preferred Stock and exercise of the Warrants.

The Company intends to use the initial net proceeds from the financing, together with the Company’s existing cash and cash equivalents to provide financing for research and development, general corporate expenses, and working capital needs.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Azitra, MAR 19, 2026, View Source [SID1234663745])

GI Innovation Announces First Clinical Supply Agreement to Explore Combination Therapy for Prostate Cancer

On March 19, 2026 GI Innovation reported that it has entered into a clinical supply agreement with Johnson & Johnson to evaluate a combination therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) in a phase 1b clinical trial.

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This trial aims to evaluate the combination of GI Innovation’s immuno-oncology agent GI-102 with pasritamig (KLK2-CD3), a first-in-class bispecific T-cell engager. This trial will explore the therapeutic potential of the combination regimen in patients with mCRPC, a disease area with limited treatment options.

Under the terms of the clinical supply agreement, Johnson & Johnson will provide pasritamig to GI Innovation, who will be the sponsor of the Phase 1b clinical trial. The study will be conducted in both Korea and the United States. Dr. Mark Stein of Columbia University Irving Medical Center will serve as the global coordinating investigator. In Korea, leading tertiary hospitals including Asan Medical Center and Severance Hospital will participate in the study.

Dr. Myoung-ho Jang, CEO of GI Innovation, stated, "This agreement represents a meaningful step toward validating the potential of GI-102 in combination with next-generation modalities such as T cell engagers together with Johnson & Johnson. As combination strategies become increasingly important in the field of immuno-oncology, clinical collaborations with global partners will serve as an important opportunity to further strengthen the technological credibility of our platform".

(Press release, GI Innovation, MAR 19, 2026, View Source [SID1234663763])

Biofrontera Inc. Reports Record Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update

On March 19, 2026 Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, reported financial results for the three and twelve months ended December 31, 2025 and provided a business update.

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Fourth Quarter Financial Highlights

Revenues for 4Q25 were a record $17.1 million, a 36% increase compared to $12.6 million for the same period in 2024.
Gross margins were 82.4%, a roughly 2,400 basis point year over year increase compared to 58.0% in 4Q24, reflecting the transition away from the transfer pricing model under the prior license and supply agreement.
Operating income was $4.6 million in 4Q25 compared to a loss of $1.7 million in 4Q24.
Cash balance was $6.4 million as of December 31, 2025.
Recent Operational Highlights

Announced positive results of its Phase 2b clinical trial evaluating Ameluz topical gel, 10% used in combination with the RhodoLED red-light lamp series for the treatment of moderate to severe acne vulgaris (AV).
Announced FDA’s completion of its filing review and filing acceptance of the Company’s supplemental New Drug Application (sNDA) for Ameluz Photodynamic Therapy (PDT) for the treatment of superficial basal cell carcinoma (sBCC).
Announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz PDT with the red-light LED (RhodoLED) platform for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk.
Announced database lock of Phase 1 pharmacokinetics study required for FDA filing on treatment field on extremities, neck and trunk of up to 240 cm2.
Closed the purchase of all Ameluz and RhodoLED US Assets from Biofrontera AG. New earnout structure reduces payment rate from 25%–35% to 12%–15% of U.S. net sales.
Received the final $2.5 million of $11 million financing led by existing investors in October.
In November, announced the divestiture of its Xepi antibiotic cream to Pelthos Pharmaceuticals for $3 million at closing, $1 million upon commercial availability, and up to $6 million in milestone payments tied to revenue thresholds of $10 million and $15 million.

(Press release, Biofrontera, MAR 19, 2026, View Source [SID1234669305])

Congruence Announces $39.5M Financing to Advance Portfolio of Small Molecule Correctors into the Clinic

On March 19, 2026 Congruence Therapeutics, a clinical-stage, computationally-driven biotechnology company building a unique pipeline of pharmacological correctors for diseases of protein misfolding, including MC4R-deficient (MC4R-d) genetic obesity, GBA1-driven Parkinson’s disease and Alpha-1 antitrypsin (A1AT) deficiency, reported the closing of a US $39.5 million financing.

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The financing was co-led by new investor Dimension and existing investor OrbiMed. Additional investors included Amplitude Ventures, FSTQ, Lumira, Investissement Quebec, BDC Capital’s Thrive Venture Fund, Driehaus, and Silver Arc.

"Our mission is to translate biology, chemistry and protein structural insights into medicines that address disease at its molecular origin," said Dr. Clarissa Desjardins, co-founder and CEO of Congruence Therapeutics. "In addition to CGX-926, we are advancing multiple proprietary and collaborative programs. We thank our new and existing investors for their continued support."

Proceeds from the financing will support the Phase 1/1b study of CGX-926, the Company’s lead program for MC4R-deficient genetic obesity, in healthy subjects and patients with MC4R-deficiency. Congruence also plans to complete IND-enabling activities for two additional development candidates targeting GBA1-driven Parkinson’s Disease and Alpha-1 antitrypsin deficiency, with the goal of filing a CTA/IND for both programs in early 2027.

"Leveraging cutting edge molecular dynamics and machine learning, Congruence has built a best-in-class platform to unlock an exciting modality of medicines in small molecule correctors," said Zavain Dar, Founder & Managing Partner, Dimension. "In short order Clarissa and team have demonstrated technology and scientific leadership, joined with strong execution and capital efficiency. This is the promise of technologically enabled biotech. We’re thrilled to join as CGX-926 enters the clinic and we see the translation of the platform’s unique capabilities."

Congruence also continues to advance its R&D collaborations, including a recently expanded multi-target partnership with Ono Pharmaceuticals in which Congruence is leading the effort to discover small molecules for targets spanning the therapeutic areas of oncology, neurology, and immunology. The Company is separately advancing another collaboration with an undisclosed global pharmaceutical company on a difficult to drug metabolic target.

About Revenir Drug Discovery Platform

Revenir, Congruence’s proprietary computational drug discovery platform, captures the dynamic biophysical changes of proteins in different functional states, offering unique insights into protein function and their modulation. By examining surface features and a spectrum of biophysical descriptors across an ensemble of protein conformers, Revenir predicts small molecule induced modulation of underlying physiologic protein states. This platform-driven strategy underpins Congruence’s growing pipeline of first-in-class and best-in-class programs directed to genetically validated targets implicated in conditions associated with significant unmet medical need, supporting a readily scalable and repeatable value creation paradigm.

(Press release, Congruence Therapeutics, MAR 19, 2026, View Source [SID1234663746])

D3 Bio to Showcase Its Innovative KRAS Pipeline at AACR 2026, Including an Oral Presentation at Clinical Plenary Session

On March 19, 2026 D3 Bio Inc, a global clinical-stage biotechnology company focused on developing transformative oncology therapeutics, reported that five abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, one of the most impactful oncology conferences in the world, taking place April 17–22 in San Diego, California. Notably, two of the five abstracts have been selected for oral presentations at the Clinical Trials Plenary Session and the Clinical Trials Mini-Symposium, respectively. These presentations will highlight data from D3’s robust and comprehensive pipeline targeting KRAS-driven cancers.

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Details of the oral presentations are as follows:

Safety and efficacy of Elisrasib (D3S-001), a next generation GDP-bound KRAS G12C inhibitor, as monotherapy in advanced non-small cell lung cancer (NSCLC) previously treated with or without a KRAS G12C inhibitor: Results from a phase 1/2 study
Session Title: Clinical Trials Plenary 1: New Frontiers in Precision Oncology
Date & Time: Sunday, April 19, 2026, 1:00 PM – 3:00 PM
Presentation Number: CT020
This will be presented as an oral presentation in a Clinical Trials Plenary Session.
Safety and efficacy of Elisrasib (D3S-001), a next generation GDP-bound KRAS G12C inhibitor, as monotherapy or combination therapy with cetuximab in previously treated metastatic CRC and PDAC: Results from a phase 1/2 study
Session Title: Advances in Precision Oncology
Date & Time: Tuesday, April 21, 2026, 2:30 PM – 4:30 PM
Presentation Number: CT303
This will be presented as an oral presentation in a Clinical Trials Mini-Symposium session.
Details of the poster presentations are as follows:

First in human phase 1 study of D3S-002, a purposely designed ERK1/2 inhibitor, in advanced solid tumors with MAPK pathway mutations
Session Title: First-in-Human Phase I Clinical Trials
Date & Time: Monday, April 20, 2026, 9:00 AM – 12:00 PM
Location: Poster Section 50
Poster Board Number: 20
Abstract Presentation Number: CT060
First-in-human clinical pharmacokinetic prediction of D3S-003, an orally bioavailable dual-state KRAS G12D inhibitor
Session Category: Experimental and Molecular Therapeutics
Session Title: Quantitative Pharmacology and Translational Modeling
Date & Time: Monday, April 20, 2026, 9:00 AM – 12:00 PM
Location: Poster Section 17
Poster Board Number: 19
Abstract Presentation Number: 1831
D3S-003, an orally bioavailable potent and selective dual-state inhibitor targeting both GDP- and GTP-bound KRAS G12D
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 2
Date & Time: Tuesday, April 21, 2026, 9:00 AM – 12:00 PM
Location: Poster Section 17
Poster Board Number: 12
Abstract Presentation Number: 4569
"We are excited to present new clinical and preclinical data at this year’s AACR (Free AACR Whitepaper) Annual Meeting" said George Chen, Founder, Chairman and Chief Executive Officer of D3 Bio. "These presentations will showcase our comprehensive KRAS pipeline, including Elisrasib (D3S-001), our next-generation KRAS G12C inhibitor, D3S-002, a selective ERK1/2 inhibitor designed with a unique profile for combination strategies to enhance clinical efficacy and overcome resistance to KRAS G12C inhibitors; and D3S-003, our differentiated KRAS G12D inhibitor addressing large unmet medical needs in pancreatic and colo-rectal cancers. These data highlight D3 Bio’s strong scientific progress and commitment to advancing transformative therapies for patients with KRAS-driven cancers. We look forward to engaging with the global scientific community and sharing our progress at AACR (Free AACR Whitepaper) and ultimately bringing new treatment options to patients."

About Elisrasib (D3S-001)

Elisrasib is a nextgeneration KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP-bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib‑ is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C–mutant solid tumors including NSCLC, CRC, and others.

Key publications:

Cancer Discovery (2024) 14(9):1675–1698
Nature Medicine (2025) 31(8):2768–2777
About D3S‑002

D3S‑002 is a selective ERK1/2 inhibitor strategically designed for combination approaches, providing vertical MAPK‑pathway inhibition to enhance efficacy and overcome acquired resistance, particularly in tumors previously treated with KRAS G12C inhibitors.

Key publication:

Cancer Res 1 April 2023; 83 (7_Supplement): 5501.
About D3S‑003

D3S‑003 is a differentiated KRAS G12D inhibitor targeting both OFF and ON conformations to address one of the most common KRAS mutations. The program aims to broaden D3 Bio’s multi‑allele KRAS franchise and deliver new solutions to the heterogeneous and evolving landscape of KRAS‑driven cancers.

(Press release, D3 Bio, MAR 19, 2026, View Source [SID1234663764])