Cabozantinib (s)-Malate

Positive proof-of-concept clinical data show substantial improvements in visual acuity in limbal stem cell deficiency ( LSCD) patients treated with CSB-001 Pivotal studies for CSB-001 in LSCD planned for 1H 2027 Series B funds Claris through pivotal development and supports pre-commercialization activities Stephen Brady appointed President and Chief Executive Officer, Brian Baum named Chief Commercial Officer, and Marc de Garidel appointed Chairman of the Board ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); JERSEY CITY, N.J., July 28, 2026 (GLOBE NEWSWIRE) -- Claris Biotherapeutics, Inc. , a late-stage biopharmaceutical company dedicated to advancing transformative therapies for sight-threatening conditions where limited or no treatment options exist, today announced multiple key milestones, including the close of a $118 million Series B financing and key executive and board appointments. These catalysts are designed to accelerate the company’s next phase of growth as it advances CSB-001 (oremepermin alfa ophthalmic solution) based on positive proof-of-concept data towards the planned initiation of pivotal studies in 1H 2027 in patients with limbal stem cell deficiency (LSCD), a blinding disease impacting the ocular surface, representing an area of high unmet need where no approved drug therapy exists. Financing Details The $118M Series B financing was co-led by new investors Samsara Biocapital and Catalio Capital Management, and joined by Adage Capital Management, Sofinnova Investments, Aisling Capital, and ADAR1 Capital Management, with continued support from all existing investors, Novo Holdings, Janus Henderson Investors, and Mass General Brigham Ventures. Proceeds from the fundraise will be used to complete Claris’ ongoing clinical trials in patients with LSCD, including a proof-of-concept study evaluating CSB-001 and a non-interventional natural history study. The financing will also fund the company through a planned pivotal program of CSB-001 in patients with LSCD, scheduled to start in 1H 2027, and enable pre-commercialization activities. CSB-001 targets the underlying pathophysiology of LSCD by promoting corneal epithelial regeneration while modulating inflammation and fibrosis. Clinical data generated to date have demonstrated substantial improvements in visual acuity. Claris expects to report its proof-of-concept results in LSCD during the second half of 2026. In connection with the financing, Stephen Brady, President and CEO of Claris, Mike Dybbs, Ph.D., Partner at Samsara Biocapital, Matthew Hobson, Ph.D., Principal at Catalio Capital Management, and Maha Radhakrishnan, M.D., Executive Partner at Sofinnova Investments, joined the board of directors. Claris Appointments Stephen Brady, President & CEO , has nearly 30 years of operational, transactional, and board experience spanning corporate strategy, M&A, business development, and finance across public and private life sciences companies. Prior to Claris, Mr. Brady was the Chairman of the Board and CEO of Tempest Therapeutics, and prior to this position, he was executive vice president of strategy and finance at Immune Design and played a key role in the company's IPO, financings, licensing deals, and eventual sale to Merck. Earlier in his career, he held progressively senior roles at several biopharmaceutical companies, including vice president of corporate development at Proteolix. In this position, Mr. Brady led Proteolix’s business development and strategic efforts that culminated in the company’s sale to Onyx Pharmaceuticals. Proteolix’s lead asset, Kyprolis ® (carfilzomib), subsequently became the cornerstone of Onyx and a principal driver of Amgen’s $10.4 billion acquisition of Onyx. Mr. Brady currently serves on the Board of Directors of Claris and the Biotechnology Innovation Organization (BIO). Brian Baum, CCO, brings to Claris more than 20 years of program and lifecycle management, commercial strategy, marketing, market access, commercial operations, and specialty product launch experience in biopharma. Prior to Claris, Mr. Baum served as Senior Vice President at Dompé Pharmaceuticals and led critical commercial initiatives that supported the successful U.S. launch and growth of Oxervate ® , a recombinant human nerve growth factor approved in 2018 for neurotrophic keratitis, a rare and serious eye disease with no prior FDA-approved therapies. As a senior commercial leader, Mr. Baum played a key role in driving Oxervate’s growth, with annual U.S. sales surpassing $1.1 billion in 2024. Prior to Dompé, Mr. Baum spent ten years at Genentech in a range of U.S. and global commercial leadership roles, including supporting the launch and commercialization of Lucentis ® across three major retinal indications: wAMD, RVO, and DME. Marc de Garidel, Chairman, is a recognized biotech entrepreneur and global pharmaceutical executive with a distinguished track record of building and scaling innovative healthcare companies, advancing breakthrough therapies, and creating substantial shareholder value through organic growth and strategic M&A across the biotechnology sector. Since May 2023, Mr. de Garidel has served as CEO of Abivax, leading the development of obefazimod for ulcerative colitis and driving exceptional corporate growth, from a $500 million to a $14 billion company in over three years. Prior to Abivax, he was CEO of CinCor Pharma from 2020 to 2023, where he successfully led the company through its acquisition by AstraZeneca. CinCor’s lead therapy was subsequently approved by the FDA as a first-in-class treatment for resistant hypertension. From 2018 to 2020, Mr. de Garidel served as CEO of Corvidia Therapeutics, overseeing its strategic growth and successful acquisition by Novo Nordisk. Earlier in his career, he served as CEO of Ipsen from 2010 to 2016, where he transformed the company into a leading global oncology player through the expansion of Somatuline and the landmark ex-U.S. licensing agreement for Cabometyx. Mr. de Garidel began his career at Eli Lilly and Company before spending 15 years at Amgen in senior international leadership roles. He has also served as Chairman of Ipsen since late 2010. “I’m thrilled to join Claris at such a pivotal moment in the company’s evolution,” said Mr. Brady, President and CEO of Claris. “The strong interest in CSB-001 reflects both its promise for patients and commercial potential. With the company financed through Phase 3 and the team in place to execute, we're ready to advance CSB-001 from a position of strength. The prospect of significantly improving vision with a convenient eye drop is a tremendous advance, and I'm energized by the opportunity to take on a blinding disease like LSCD.” Marc de Garidel, Chairman of Claris Bio, added, “Claris is entering a defining period in its growth. In addition to welcoming Steve and Brian to Claris’ leadership team, I’d like to thank our founding CEO, Clarke Atwell, for his years of diligence in building the team and advancing the science underlying CSB-001, which allows us to approach this watershed moment with confidence. We look forward to continuing our work to advance CSB-001 in patients with limbal stem cell deficiency and lead the company through its next phase as we approach commercialization.” About LSCD and CSB-001 Limbal stem cell deficiency (LSCD) is a disease of the eye in which specialized stem cells that continuously replenish and repair the corneal surface are damaged or destroyed, leading to severe vision loss or blindness. CSB-001 (oremepermin alfa ophthalmic solution) contains recombinant human deleted hepatocyte growth factor (dHGF) as its active ingredient. By promoting corneal epithelial regeneration while modulating inflammation and fibrosis, CSB-001 is intended to address the underlying pathophysiology of LSCD. Clinical data to date demonstrate substantial improvements in visual acuity in LSCD patients treated with CSB-001. If approved, CSB-001 has the potential to become the first pharmacologic treatment for LSCD, providing a reliable, accessible, and scalable non-surgical treatment option. Claris and Kringle Pharma, Inc., a company developing oremepermin alfa for non-ophthalmic indications, have a safety-data sharing collaboration that has enabled a more efficient development of oremepermin alfa. Estimates indicate that at least 30,000 LSCD patients in the U.S. are actively being managed by an eye care professional, although given the lack of diagnosis, the number is likely larger. Ongoing and Planned CSB-001 Clinical Studies Proof-of-Concept Study. An open-label clinical study evaluating the safety and efficacy of CSB-001 eyedrops in 63 LSCD subjects is ongoing. Subjects receive CSB-001 investigational eye drops in either one or both eyes over 20 weeks beginning on Day 0, or at Week 20 after a 20 week observational period. Completion of dosing is followed by an observational period. More information can be found at clinicaltrials.gov (NCT06452316): Pivotal Studies. In 1H 2027, Claris plans to initiate two pivotal studies evaluating the safety and efficacy of CSB-001 compared to vehicle in a total of approximately 400 LSCD subjects. The primary efficacy endpoint will be visual acuity supported by anatomical endpoints. Non-Interventional Study. To prepare for the planned pivotal studies, Claris is currently conducting a prospective non-interventional study in subjects with LSCD. This study will provide insights into the natural history of LSCD and characterize real-world LSCD management patterns, and identify and qualify investigative sites and potential study participants for the planned pivotal studies. More information can be found at clinicaltrials.gov (NCT07636590): About Claris Bio Claris Biotherapeutics is a late-stage biopharmaceutical company dedicated to advancing transformative therapies for sight-threatening conditions where no or limited treatment options exist. With an initial focus on limbal stem cell deficiency (LSCD), a blinding disease, we are developing the first pharmacologic treatment with the potential to provide a reliable, accessible, and scalable non-surgical treatment option, while moving medical management beyond today's palliative care and towards meaningful improvements in vision and ocular surface health. Our near-term plan is to advance our lead therapeutic candidate, CSB-001 (oremepermin alfa ophthalmic solution), into LSCD pivotal studies in the first half of 2027, with a longer-term goal to become a leader in developing new therapies that improve vision and change patients’ lives. Foundational intellectual property for Claris was based on the scientific work of Drs. Reza Dana, MD, MSc, MPH, and Sunil Chauhan, DVM, PhD., both from the Massachusetts Eye and Ear and the Harvard Medical School Department of Ophthalmology. To learn more, visit . Media Contact Jordyn Temperato LifeSci Communications jtemperato@lifescicomms.com

– Response rates up to 50% across evaluated dose levels and median PFS of 13 months observed in pre-treated, cabozantinib-naïve, locally advanced or metastatic ccRCC patients – – Activity compares favorably with historical outcomes for TKI and HIF-2 α monotherapies -– – Combination was well tolerated and safety pro with reported profiles of the individual agents – – Findings support potential for darlifarnib to enhance activity of VEGFR-targeted therapies in second- and third-line RCC settings – ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); – Global, randomized Phase 1b study underway to establish recommended Phase 3 dose – – Investor call scheduled for today, July 27, 2026, at 5:00 a.m. PT / 8:00 a.m. ET – SAN DIEGO, July 27, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, announced updated Phase 1a results from the ongoing FIT-001 clinical trial ( NCT06026410) demonstrating encouraging and durable clinical activity of darlifarnib plus cabozantinib in cabozantinib-naïve patients with advanced clear cell renal cell carcinoma (ccRCC). The results were presented at the 2026 Kidney Cancer Research Summit (KCRS) in Boston and support continued development of the combination, including dose selection for the randomized Phase 1b portion of the study. The long-term data compare favorably with benchmarks for advanced RCC, showing robust antitumor activity with darlifarnib plus cabozantinib, as well as evidence of durable benefit. The combination had a manageable safety pro all dose levels, including when administered with full-dose cabozantinib. Clinical Activity in Cabozantinib-naïve ccRCC Patients (N=34): Objective response rate ranged from 33% to 50% across evaluated darlifarnib dose levels Median progression free survival was 13 months across pooled dose levels Median duration of response was not estimable at most dose levels assessed because multiple responses remain ongoing Durable clinical benefit was observed across all evaluated combination dose levels, with more than half of patients remaining on treatment at data cut-off Safety and Tolerability in RCC Patients (N=72): The safety and tolerability pro manageable and generally consistent with reported safety profiles of the individual agents Supportive care, including for neutropenia, was not allowed during the dose-limiting toxicity study period Neutropenia was successfully managed with dose interruption/reduction and supportive care (as allowed after the initial dose-limiting toxicity period) “The response rates and progression-free survival observed with darlifarnib plus cabozantinib are encouraging in this refractory, pretreated, cabozantinib-naïve population, particularly given the limited treatment options after prior immunotherapy, immune check point inhibitors, and VEGFR-targeted therapy,” said Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology, Assistant Medical Director Clinical Trials Office, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. “Continued follow-up will further define the durability of benefit.” Duration of Treatment and Clinical Outcomes Clinical benefit observed across combination dose levels, with multiple patients remaining on treatment. “These updated Phase 1a data continue to support the potential for darlifarnib to enhance VEGFR-targeted therapy in advanced RCC and have informed the dose combinations advancing into the randomized Phase 1b portion of FIT-001,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “Cabozantinib-naïve patients represent an increasingly important treatment population as cabozantinib is often reserved for later lines of therapy following immunotherapy-based regimens. We look forward to longer follow-up from Phase 1a and randomized data from Phase 1b as we continue development toward a planned registrational study.” Kura is currently enrolling patients in the U.S. and E.U. in the randomized Phase 1b dose-optimization portion of FIT-001 in cabozantinib-naïve, refractory ccRCC. The Phase 1b portion is evaluating darlifarnib plus cabozantinib versus cabozantinib alone and is designed to inform selection of a recommended Phase 3 dose for a planned registrational study in 2028. Virtual Investor Event Kura will host a webcast and conference call today, July 27, 2026, at 5:00 a.m. PT / 8:00 a.m. ET featuring management and Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology and Assistant Medical Director, Clinical Trials Office, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. The live webcast and replay will be available on the Company’s website at under the Investors tab in the Events and Presentations section. Abbreviations HIF-2α, hypoxia-inducible factor 2 alpha; PD, progressive disease; PFS, progression-free survival; PR, partial response; RCC, renal cell carcinoma; SD, stable disease; TKI, tyrosine kinase inhibitor; VEGFR, vascular endothelial growth factor receptor About Darlifarnib Darlifarnib is a next-generation farnesyl transferase inhibitor (FTI) under development that inhibits farnesylation of RHEB, resulting in selective mTORC1 inhibition while sparing mTORC2. This mechanism has potential to enhance the activity of multiple targeted therapies where complementary inhibition of oncogenic pathways may improve clinical outcomes, including VEGFR-targeted therapies such as cabozantinib. About Kura Oncology Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI ® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1 -mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website at and follow us on X and LinkedIn . Forward-Looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of darlifarnib to enhance the activity of cabozantinib and other VEGFR-targeted therapies in RCC and to improve clinical outcomes, the potential of darlifarnib in combination with cabozantinib to offer durable benefit to patients with RCC, and ongoing and planned clinical trials of darlifarnib in combination with cabozantinib. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at . Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Conflict of Interest Disclosure Dr. Ayanambakkam's disclosures include consulting or advisory roles with AVEO, Pfizer/Astellas; Johnson & Johnson; Kura Oncology: Travel, Accommodations, Expenses, and Research Funding; and Regeneron. Kura Contact Investors and Media: Greg Mann 858-987-4046 gmann@kuraoncology.com A photo accompanying this announcement is available at