On March 5, 2026 Kestrel Therapeutics Inc. ("Kestrel" or the "Company"), a clinical stage biotechnology company developing next-generation small-molecule inhibitors targeting mutant KRAS, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for KST-6051, an investigational, oral, small-molecule inhibitor designed to target KRAS.

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Kestrel is advancing KST-6051 into the clinic and expects to initiate a first-in-human Phase 1 dose-escalation clinical trial FALCON by the end of the first quarter. The trial, designed to evaluate safety, tolerability and preliminary anti-tumor activity, will enroll patients with advanced or metastatic KRAS-mutant solid tumors, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and others.

"IND approval for KST-6051 is a significant milestone for Kestrel and an important step forward for patients with KRAS-driven cancers," said Dr. Frank G. Haluska, President and Chief Executive Officer of Kestrel Therapeutics. "KST-6051 represents our next-generation approach to pan-KRAS inhibition, leveraging proprietary and unique Switch-II pocket chemistry to target KRAS in both the ON- and OFF-states. We are excited to initiate our first study as we work toward initial clinical readouts anticipated in late 2026."

About KST-6051

KST-6051 is a potential best-in-class, oral pan-KRAS inhibitor, developed for the treatment of KRAS-driven cancers. KST-6051 is a potent and selective inhibitor of KRAS with activity against KRAS in both its active (GTP-bound) and inactive (GDP-bound) states. Preclinical data demonstrate robust on-target pathway modulation, anti-proliferative activity, and efficacy at well-tolerated doses in multiple human KRAS mutant tumor models. The Company is initiating a Phase 1 study in patients with KRAS-mutant advanced/metastatic solid tumors. Its clinical development will ultimately address pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and other KRAS-driven malignancies.

(Press release, Kestrel Therapeutics, MAR 5, 2026, View Source [SID1234663319])

On March 5, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinicaal-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, reported a business update and announced full year 2025 financial results.

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"2026 is on track to be transformational for NextCure, as we set the stage to present clinical dose escalation data from the Phase 1 trial for SIM0505, in development for multiple cancers," said Michael Richman, President and CEO of NextCure. "Since acquiring the program in June of 2025, we have made rapid clinical and regulatory progress and soon expect to begin enrolling platinum resistant ovarian cancer patients in the Phase 1 dose optimization study. To accelerate the program, we plan to double the number of U.S. trial sites and expand our footprint into multiple other countries."

Business Highlights and Near-Term Milestones

SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026

SIM0505 is a novel ADC directed to cadherin-6 (CDH6 ADC), overexpressed in several cancers including ovarian cancer, with limited expression in healthy tissues. SIM0505 features a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window.

● Data from the Phase 1 open-label dose escalation study is expected to be presented in the second quarter of 2026, including results from patients in the U.S. and China.
● The study (NCT06792552) is evaluating SIM0505 in patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on platinum resistant ovarian cancer (PROC).
● Initiation of Phase 1 dose optimization study in ovarian cancer expected in the second quarter of 2026 with a continued focus on PROC. The Company anticipates doubling the number of trial sites in the second half of 2026, including the activation of sites in Canada and Europe, with continued study site additions in 2027.

LNCB74 (B7-H4 ADC): Ongoing enrollment in Phase 1 dose escalation

LNCB74 is a novel ADC directed to B7-H4, overexpressed in several cancers, with limited expression in healthy tissues. LNCB74 features a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload.

● Higher dose cohort enrollment initiated in the ongoing open-label Phase 1 dose escalation study (NCT06774963), following the November 2025 protocol amendment announcement. The next dose cohort will prioritize patients with high B7-H4 expression in breast and gynecological cancers, as well as the inclusion of patients with adenoid cystic carcinoma type 1.
● NextCure continues to plan to provide a trial update in the second half of 2026.

Financial Results for the Full Year Ended December 31, 2025

● Cash, cash equivalents, and marketable securities as of December 31, 2025 were $41.8 million as compared to $68.6 million as of December 31, 2024. The decrease of $26.8 million was primarily due to cash used to fund operations of $49.6 million, including $13.5 million of upfront license fees and milestone payments to Simcere Zaiming Pharmaceutical Co., Ltd. for the rights to SIM0505, partially offset by proceeds of $22.3 million from equity sales including a $21.5 million private placement of common stock in November 2025. NextCure expects current financial resources to be sufficient to fund operating expenses and capital expenditures into the first half of 2027 through proof-of-concept for SIM0505.
● Research and development expenses were $44.9 million for the full year ended December 31, 2025, as compared to $41.5 million for the full year ended December 31, 2024. The increase of $3.4 million was due to $18.5 million of license fees and milestone payments for SIM0505 partially offset by lower costs related to deprioritized programs, lower preclinical development costs and lower personnel-related costs.
● General and administrative expenses were $12.7 million for the full year ended December 31, 2025, as compared to $15.7 million for the full year ended December 31, 2024. The decrease of $3.0 million was primarily related to lower personnel costs.
● Net loss was $55.8 million for the full year ended December 31, 2025, as compared to a net loss of $55.7 million for the full year ended December 31, 2024. Net loss for the year ended December 31, 2025 was driven by higher research and development costs and lower other income of $2.3 million, partially offset by lower general and administrative costs and lower restructuring charges.

About SIM0505

SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds

exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.

About LNCB74

LNCB74 is a novel antibody drug conjugate (ADC) directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload. LNCB74 is being evaluated in an open-label, Phase 1 dose escalation study for the potential treatment of advanced solid tumors. NextCure shares global co-development rights with LigaChem Biosciences, Inc. through a 50-50 cost share arrangement.

(Press release, NextCure, MAR 5, 2026, View Source [SID1234663302])

On March 5, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported a clinical trial collaboration and supply agreement (CTCSA) with Tango Therapeutics, Inc. (Nasdaq: TNGX; "Tango") to evaluate Erasca’s pan-RAS molecular glue, ERAS-0015, with Tango’s PRMT5 inhibitor, vopimetostat (TNG462).

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"We’ve disclosed encouraging early clinical activity for our potential best-in-class molecular glue, ERAS-0015, including first clinical responses in multiple patients with differing tumor types and RAS mutations at just 1/10th of the dose at which first clinical responses were observed with RMC-6236," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Combining ERAS-0015 with Tango’s potentially first-in-class PRMT5 inhibitor represents a promising opportunity to redefine the standard of care in patients with MTAP-deleted RAS-mutant (MTAPdel RASm) cancers, where treatment options remain limited. We are excited to partner with Tango to evaluate this approach in these patients with high unmet needs."

This agreement will support a Phase 1/2 clinical trial evaluating ERAS-0015 in combination with vopimetostat in patients with MTAPdel pancreatic or MTAPdel RASm non-small cell lung cancer (NSCLC). Erasca will supply ERAS-0015 free of charge, and Tango will be the trial sponsor. Each company will retain commercial rights to their respective compound, and the agreement is mutually non-exclusive.

Nearly all MTAP-deleted pancreatic cancers and 30% of MTAP-deleted NSCLC tumors harbor co-occurring RAS mutations, creating a dependency that makes these cancer cells particularly susceptible to simultaneous RAS and PRMT5 inhibition. Combining a pan-RAS molecular glue with a PRMT5 inhibitor may provide a differentiated, dual-targeted approach designed to shut down the RAS signaling pathway and more strongly suppress PRMT5 in MTAP-deleted tumor cells, potentially leading to deeper and more durable responses and reducing the likelihood of resistance in these difficult-to-treat cancers.

About ERAS-0015
ERAS-0015 is an oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile. Erasca is evaluating ERAS-0015 in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumors. Early dose escalation data in AURORAS-1 demonstrated favorable safety and tolerability, well-behaved, linear PK, and confirmed and unconfirmed responses in multiple patients across multiple tumor types with different RAS mutations, including confirmed and unconfirmed partial responses at doses as low as 8 mg once daily (QD). In preclinical studies versus RMC-6236, ERAS-0015 demonstrated approximately 8-21 times higher binding affinity to cyclophilin A (CypA) , approximately 5 times greater potency in RAS inhibition, and greater in vivo antitumor activity evidenced by achieving comparable or greater tumor growth inhibition or regression at doses that are as low as approximately one-tenth to one-fifth of the dose of RMC-6236. ERAS-0015 is also designed to prevent resistance against mutant-selective inhibitors through inhibition of RAS wildtype variants. In addition, ERAS-0015 has demonstrated favorable absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) properties in multiple animal species.

(Press release, Erasca, MAR 5, 2026, View Source [SID1234663320])

On March 5, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported it will webcast management participation at the Barclays 28th Annual Global Healthcare Conference at 9:00 a.m. ET on Tuesday, March 10, 2026.

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The session may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A replay and transcript of the webcast will be archived on the Company’s website for at least 30 days.

(Press release, Regeneron, MAR 5, 2026, View Source [SID1234663304])

On March 5, 2026 Atavistik Bio, a biotechnology company discovering the next generation of selective allosteric therapeutics, reported the closing of a $40 million extension to its Series B financing from new investor RA Capital Management, bringing the total round proceeds to $160 million. RA Capital joins other top-tier investors who participated in the Series B round, including Nextech Invest, The Column Group, Lux Capital and Regeneron Ventures, as previously announced in December 2025. Atavistik Bio will use the proceeds from the upsized Series B financing to fund clinical development of ATV-1601, a potential best-in-class AKT1-selective oral inhibitor for HHT, and its JAK2 V617F mutant-selective inhibitor program for MPNs through clinical proof of concept.

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"We’re excited to welcome RA Capital as an investor in Atavistik Bio. Our Series B round, backed by a highly respected syndicate, reflects strong belief in our selective allosteric programs and our focus to advance meaningful therapies for patients with severe diseases," said Bryan Stuart, Chief Executive Officer at Atavistik Bio. "This additional funding further strengthens our ability to accelerate the development of best-in-class therapies designed to deliver superior efficacy, improved tolerability profiles, and potentially transformative outcomes for patients."

"We are pleased to support Atavistik Bio in this next phase of growth as the company is at the forefront of developing transformative therapies for HHT and MPNs," said Nandita Shangari, PhD, Managing Director at RA Capital Management. "Atavistik Bio’s highly experienced team and a pipeline of high-quality programs targeting significant unmet need, position the company to create meaningful value."

About Hereditary Hemorrhagic Telangiectasia (HHT), AKT1 Inhibition and ATV-1601

HHT is a severe inherited bleeding disorder that affects more than 1.6 million people globally, with no approved therapies currently available. This condition often leads to frequent bleeding episodes and vascular shunts, resulting in chronic anemia, multiorgan damage, and life-threatening complications. AKT1 hyperactivation is a hallmark of HHT and has been shown to drive the vascular pathology of HHT. Selectively inhibiting AKT1, the primary AKT isoform and driver of abnormal endothelial growth implicated in HHT, offers a novel and potentially disease-modifying therapeutic approach for this difficult disease. Although there has been substantial investment in pan-AKT inhibitors, their use is limited by AKT2-driven toxicities, most notably hyperglycemia, which impact tolerability and restrict their use for chronic dosing. ATV-1601 is an oral allosteric inhibitor that selectively inhibits AKT1.

ATV-1601 was evaluated in a Phase 1 oncology study, and demonstrated a favorable safety profile, validating its differentiated selectivity profile that addresses key limitations of pan-AKT inhibitors. Development efforts will now focus on advancing ATV-1601 in HHT.

About Myeloproliferative Neoplasms (MPNs) and Selective Targeting of the JAK2 V617F Mutation

MPNs are a group of rare chronic blood cancers for which current treatment options are limited. The JAK2 V617F mutation is the most common driver mutation in patients living with MPNs, affecting approximately 95% of patients with polycythemia vera, 60% of patients with essential thrombocythemia, and 55% of patients with myelofibrosis. Approved pan-JAK inhibitors, such as ruxolitinib, provide symptom relief, but non-selectively inhibit both mutant and wild-type JAK2. This limits the ability to reduce JAK2 V617F mutant allele burden and can disrupt normal blood cell production regulated by wild-type JAK2, contributing to adverse events and treatment discontinuation. Selectively targeting the JAK2 V617F mutation has the potential to reduce mutant allele burden, preserve normal bone marrow function, and have a disease modifying impact that will substantially improve long term outcomes for patients with MPNs.

(Press release, Atavistik Bio, MAR 5, 2026, View Source [SID1234663321])