Curis Provides Fourth Quarter 2025 Business Update

On March 19, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported its business update and financial results for the quarter ended December 31, 2025.

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Operational Highlights

TakeAim Lymphoma

Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma at Dana-Farber Cancer Institute in Boston, presented a poster with updated clinical data in Primary CNS Lymphoma (PCNSL) at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) in November 2025. The poster, titled Preliminary Safety and Efficacy of Emavusertib (CA-4948) in Combination with Ibrutinib in Relapsed/Refractory Primary Central Nervous System Lymphoma Patients, showed results for 24 patients who have received treatment with emavusertib and ibrutinib, a BTK inhibitor (BTKi), for at least 1 cycle (28 days):
5 of 5 BTKi-naïve patients achieved objective response (100% ORR)
7 of 19 BTKi-experienced patients achieved objective response (37% ORR)
Median treatment duration for the 12 responders was 123 days (44 – 798 days)
9 additional patients were unable to complete 1 cycle of treatment; reasons for discontinuing treatment included adverse events unrelated to treatment, disease progression, and transition to hospice care.
Cecilia Merrigan, DNP, Mayo Clinic in Rochester, presented a poster with initial clinical data in Secondary CNS Lymphoma (SCNSL) at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) in November 2025. The poster, titled Promising Efficacy Signal in Secondary CNS Lymphoma Patients Treated with Emavusertib and Ibrutinib, showed results for 2 patients who had previously progressed on a BTKi. Adding emavusertib to their ibrutinib treatment resulted in 1 complete response (CR) and 1 stable disease (SD) with a 38% reduction in disease burden.
Curis continues to enroll PCNSL patients in the Company’s TakeAim Lymphoma study of emavusertib in combination with ibrutinib which, as a result of discussions with FDA and EMA, is intended to support filings for accelerated approval in PCNSL in the US and Europe. Emavusertib has been granted orphan drug designation by both FDA and EMA in PCNSL.
TakeAim CLL

Curis initiated an open label Phase 2 clinical study of emavusertib in combination with zanubrutinib, a BTKi, in patients with Chronic Lymphocytic Leukemia (CLL). The goal of combining emavusertib with a BTKi is to enable a dual blockade of NF-kB, a key driver of disease in CLL and NHL, by inhibiting both the TLR and BCR pathways. The current standard of care is BTKi, which blocks the BCR pathway and can deliver high response rates, though typically only partial responses. Previous clinical studies have shown that adding emavusertib, which blocks the TLR pathway, to a BTKi regimen can enable patients with NHL to achieve deeper responses, including complete remission or undetectable minimal residual disease (MRD) and the potential for time-limited treatment, outcomes which represent the potential for a paradigm shift in the management of CLL.
AML

Christina Papayannidis, MD, IRCCS Azienda Ospedaliero Universitaria di Bologna, presented a poster with initial clinical data in frontline AML at the 67th ASH (Free ASH Whitepaper) Annual Meeting in December. The AML triplet study (CA-4948-104) is evaluating the addition of emavusertib to the combination of azacitidine and venetoclax (aza-ven) in AML patients who have achieved complete remission on aza-ven but remain MRD-positive (MRD+). The first two cohorts in the study evaluate patients who received emavusertib for either 7 or 14 days in a 28-day cycle, in addition to their aza-ven treatment. The poster, titled Preliminary Pharmacokinetic and MRD Results from AML Patients Treated with 7- and 14-Day Dosing Schedule of Emavusertib added to Combination Therapy with Azacitidine and Venetoclax, showed results for 4 patients in the 7-day cohort and 6 patients in the 14-day cohort:
8 patients had central MRD samples
5 of 8 patients (62.5%) achieved MRD conversion (MRD+ to undetectable).
Corporate

On January 9, 2026, the Company announced the closing of a private placement (the "January 2026 PIPE Financing") with gross proceeds of up to $80.8 million, including initial gross proceeds of approximately $20.2 million with three series of warrants (A, B, and C) which can be exercised for up to $20.2 million each according to the terms and conditions of the financing agreement. All three series of warrants are currently exercisable at $0.75 per share and have the following termination conditions:

Series A warrants terminate on January 8, 2031
Series B warrants terminate 30 days after the Company announces dosing of the fifth patient in the Phase 2 clinical trial in CLL, subject to conditions defined in the financing agreement
Series C warrants terminate on January 8, 2027.
Fourth Quarter 2025 Financial Results

For the year ended December 31, 2025, Curis reported a net loss of $7.6 million, or $0.58 per share on both a basic and diluted basis, as compared to a net loss of $43.4 million, or $6.88 per share on both a basic and diluted basis in 2024. For the fourth quarter of 2025, Curis reported net income of $19.4 million or $1.23 per share on both a basic and diluted basis as compared to a net loss of $9.6 million or $1.25 on both a basic and diluted basis for the same period in 2024.

Revenues, net were $9.4 million and $10.9 million for the years ended December 31, 2025 and 2024, respectively. Revenues are comprised of royalty revenues related to Genentech and Roche’s net sales of Erivedge. Revenues were $1.1 million and $3.3 million for the fourth quarters of 2025 and 2024, respectively. As previously announced, on November 6, 2025, the Company sold to TPC Investments Royalty LLC, a limited liability company managed by Oberland, its interest in Curis Royalty LLC. The sale included the Erivedge intellectual property, other assets associated with Erivedge and the License Agreement with Genentech ("Erivedge"), in exchange for upfront consideration of $2.5 million and a release of the Company’s liability related to sale of future royalties to Oberland. In connection with such transaction, the Company transferred to Curis Royalty all rights to Curis Technology, Inventions and Joint Patents (each as defined in the License Agreement) and assigned the Company’s rights, duties and obligations under the License Agreement to Curis Royalty. Following the sale, the Company is no longer entitled to revenues under the License Agreement.

Research and development expenses were $28.3 million and $38.6 million for the years ended December 31, 2025 and 2024, respectively. The decrease was primarily attributable to lower employee-related, clinical, manufacturing and consulting costs. Research and development expenses were $5.8 million and $9.0 million for the fourth quarters of 2025 and 2024, respectively.

General and administrative expenses were $14.0 million and $16.8 million for the years ended December 31, 2025 and 2024, respectively. The decrease was primarily attributable to lower employee-related and legal costs. General and administrative expenses were $2.9 million and $3.4 million for the fourth quarters of 2025 and 2024, respectively.

Gain on release of liability related to sale of future royalties associated with sale of assets was the result of the sale of Erivedge. In the fourth quarter 2025, the Company recognized a non-cash $27.2 million gain and the liability related to sale of future royalties was extinguished.

Other expense, net was $1.9 million for the year ended December 31, 2025 and other income, net was $1.2 million for the year ended December 31, 2024. The increase was partially attributable to an increase in expense related to the sale of future royalties and a decrease in interest income. Other expense, net was $0.3 million and $0.6 million for the fourth quarters of 2025 and 2024, respectively.

As of December 31, 2025, Curis’s cash and cash equivalents totaled $5.1 million, and the Company had approximately 12.9 million shares of common stock outstanding.

Cash Runway Guidance

Curis believes its cash and cash equivalents as of December 31, 2025, together with initial gross proceeds of $20.2 million received in January 2026 and expected gross proceeds of up to an additional $20.2 million from the exercise of the January 2026 PIPE Financing Series B Warrants upon the public announcement of dosing the 5th CLL patient in our TakeAim CLL study expected later this year, should enable the Company’s planned operations into the second half of 2027.

Conference Call Information

Curis management will host a conference call today, March 19, 2026, at 4:30 p.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial (800)-836-8184 from the United States or (646)-357-8785 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed here on the Curis website in the Investors section.

(Press release, Curis, MAR 19, 2026, View Source [SID1234663747])

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])

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])

Oncoinvent secures new patent expanding protection for Radspherin

On March 19, 2026 Oncoinvent (OSE: ONCIN), a biotech company developing a receptor-independent alpha radiopharmaceutical to eradicate cancer cells in the abdominal cavity after surgery with a single, targeted dose, reported that the China National Intellectual Property Administration (CNIPA) has granted a new patent for Radspherin, the Company’s lead product candidate, marking the first approval worldwide within this patent family.

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The newly granted patent covers a key technical development to optimize Radspherin’s performance, specifically the size-controlled calcium carbonate microparticle technology. With this grant, patent protection for Radspherin in China is expanded in scope and duration, with a term extending to 2041. This complements the existing composition‑of‑matter patent, which is valid until 2035 (2036 in some jurisdictions). Corresponding patent applications from the same patent family remain under review in several major jurisdictions worldwide.

"We are very pleased to obtain this additional patent in China for Radspherin," said Oystein Soug, Chief Executive Officer at Oncoinvent. "As we continue to advance clinical development, it is essential that our innovation is backed by a strong and durable global intellectual property position."

(Press release, Oncoinvent, MAR 19, 2026, https://www.oncoinvent.com/press-release/oncoinvent-secures-new-patent-expanding-protection-for-radspherin/ [SID1234663708])

Molecular Partners Presents New Preclinical Data Highlighting Radio-DARPins’ Amenability to Multiple Isotopes

On March 19, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported it will hold an oral presentation outlining new preclinical data on Radio-DARPins at the 3rd Global Radiopharmaceuticals Development Summit, taking place in Shanghai, China on March 19–20, 2026.

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The presentation will outline the Radio-DARPins’ suitability to different isotopes with data on two Radio-DARPin candidates, each specific for a different tumor target. The results of studies in tumor-bearing mice show highly comparable biodistribution profiles for both Radio-DARPin candidates labeled with Lutetium-177 (177Lu) or with Lead-203 (203Pb), with similar uptake and washout rates. Imaging with 177Lu can be indicative of behavior with the therapeutic isotope Actinium-225 (225Ac), and similarly with 203Pb for 212Pb.

"Our recent data confirms that our Radio-DARPin-vector design allows interchangeability of alpha-isotopes, including 212Pb and 225Ac," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "This feature offers us the opportunity and flexibility to evaluate Radio-DARPin candidates in an isotope-agnostic manner and to choose the most suitable therapeutic isotope, as late as with initial clinical data, without having to restart the entire drug discovery and development process – a significant advantage to tailor our candidates to patient needs."

Details of the presentation

DARPins for targeted alpha therapy: from promising MP0712 first in-human data to opportunities for next Radio-DARPin candidates
Presenter: Daniel Steiner, Ph.D., SVP of Technology and Research
Time: 9:25 am CST, Friday, March 20
Location: Meeting Room B – IND Filing and Clinical Development Progress

The full presentation can be found here.

MP0712, Molecular Partners’ DLL3-targeted 212Pb-based Radio-DARPin candidate co-developed with strategic partner Orano Med, is in an ongoing Phase 1/2a trial in the US (NCT07278479). Imaging data of MP0712 carrying the diagnostic isotope 203Pb under compassionate care are supportive of clinical development plans of MP0712 carrying the therapeutic isotope 212Pb for patients with small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers.

In February 2026, Molecular Partners entered into an agreement with Eckert & Ziegler, leading specialist in isotope-related components for nuclear medicine and radiation therapy, to enable the development and manufacturing of Radio-DARPin therapeutics. Eckert & Ziegler will support Molecular Partners with a comprehensive range of services covering development activities for Radio-DARPins with 225Ac as therapeutic payload and 177Lu as imaging payload.

About Radio-DARPins
Molecular Partners’ Radio-DARPins are designed as ideal vectors for precise delivery of potent alpha-emitting isotopes to tumor lesions and have the potential to unlock a broad range of tumor targets for targeted radiopharmaceuticals. Building on the DARPins’ unique properties, Molecular Partners has developed a proprietary Radio-DARPin platform to address historic limitations of radioligand therapy, such as kidney accumulation and toxicity, and suboptimal tumor uptake. Molecular Partners’ Radio-DARPins addresses these limitations through half-life extension technologies and surface engineering approaches, while preserving the advantages of the small protein format.

(Press release, Molecular Partners, MAR 19, 2026, View Source [SID1234663707])