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Kadmon Holdings, Inc. (NASDAQ:KDMN) reported a loss from operations of $27.4 million for Q1 2021, an increase from $16.1 million in Q1 2020, primarily due to commercial launch preparations for belumosudil and higher R&D costs. The company has $295.9 million in cash and equivalents as of March 31, 2021. Anticipating the FDA's PDUFA goal date on August 30, 2021, Kadmon is preparing for the potential launch of belumosudil for chronic graft-versus-host disease (cGVHD) and exploring its use in systemic sclerosis. Initial clinical data for both indications is expected by year-end 2021.
Kadmon Holdings, Inc. (NASDAQ:KDMN) announced positive results from its Phase 2a trial of belumosudil for chronic graft-versus-host disease (cGVHD), published in the Journal of Clinical Oncology. The trial reported a 65% overall response rate among 54 patients, with a median response duration of 35 weeks. The drug demonstrated steroid-sparing effects, with 67% of patients reducing steroid use. An NDA for belumosudil is under Priority Review by the FDA, with a target action date of August 30, 2021. These results underscore the drug’s potential to meet unmet medical needs in cGVHD treatment.
Kadmon Holdings (NASDAQ:KDMN) announced the initiation of an open-label Phase 2 clinical trial for belumosudil, a ROCK2 inhibitor, targeting diffuse cutaneous systemic sclerosis (dcSSc). The trial (KD025-215) aims to enroll 15 adults, assessing the Combined Response Index for Systemic Sclerosis (CRISS) score as its primary endpoint. Preliminary data from this study is expected by year-end 2021. In parallel, another Phase 2 trial (KD025-209) is evaluating belumosudil's efficacy in a larger cohort. The FDA has granted Orphan Drug Designation for belumosudil in systemic sclerosis treatment.
Kadmon Holdings, Inc. (NASDAQ:KDMN) has announced its presentation of a trial-in-progress poster on KD033-101 at the 2021 AACR Annual Meeting, scheduled for April 10-15, 2021. KD033 is being evaluated in a Phase 1 study targeting patients with metastatic or locally advanced solid tumors, with initial safety data expected in Q2 2021 and more comprehensive clinical results anticipated in Q4 2021. KD033 combines an anti-PD-L1 antibody with IL-15 to enhance immune response against tumors.
Kadmon Holdings, Inc. (KDMN) announced the FDA has extended the review period for its New Drug Application for belumosudil, aimed at treating chronic graft-versus-host disease (cGVHD), to August 30, 2021. This extension results from a recent request for additional information from the FDA, classified as a major amendment to the NDA. Harlan W. Waksal, M.D., expressed confidence in the data supporting the application. Belumosudil, a selective oral ROCK2 inhibitor, is critical for a patient population of approximately 14,000 in the U.S. living with cGVHD.
Kadmon Holdings, Inc. (NASDAQ: KDMN) reported its Q4 and full-year 2020 financial results, revealing a loss from operations of $31.2 million for Q4 and $102.3 million for the year. The increases in losses were primarily due to heightened clinical and regulatory costs associated with belumosudil, aimed at treating cGVHD. As the company prepares for a potential launch of belumosudil, it has raised over $300 million in capital through a recent bond financing. The FDA has set a PDUFA date of May 30, 2021, for the drug's review, which is part of the Real-Time Oncology Review program.
Kadmon Holdings (NASDAQ: KDMN) has appointed Dr. Simon Cooper as Senior Vice President and Chief Medical Officer, effective March 1, 2021. Dr. Cooper will lead medical and clinical activities related to belumosudil for chronic graft-versus-host disease and advance the company's clinical pipeline. He succeeds Dr. John Ryan, who will transition to Executive Medical Director. With over 23 years of experience in immunologic therapies, Dr. Cooper has held key roles at major pharmaceutical companies, enhancing Kadmon's leadership and pipeline development efforts.
Kadmon Holdings (NASDAQ:KDMN) announced its participation in several virtual investor conferences, hosted by CEO Harlan W. Waksal. The Raymond James 42nd Annual Institutional Investors Conference will occur on March 3, 2021, at 4:40 pm ET. The H.C. Wainwright Global Life Sciences Conference will feature a presentation available from March 9, 2021, at 7:00 am ET. Lastly, the Oppenheimer's 31st Annual Healthcare Conference is scheduled for March 17, 2021, at 2:30 pm ET. Live webcasts will be available on the Kadmon website, with replays accessible for 90 days.
Kadmon Holdings announced the closing of a $240 million offering of 3.625% convertible senior notes due 2027, including a $40 million over-allotment option. The initial conversion price is $6.96 per share, representing a 30% premium over its common stock closing price of $5.35 on February 10, 2021. Following capped call transactions, the effective conversion price is raised to $10.70 per share, a 100% premium. Net proceeds are estimated at $232.8 million, aimed at commercializing belumosudil for chronic graft-versus-host disease, advancing other clinical candidates, and other corporate needs.
Kadmon Holdings has announced a successful pricing of $200 million in 3.625% convertible senior notes due 2027, up from the initially proposed $150 million. The offering includes capped call transactions and allows the initial purchaser a 13-day option to acquire an additional $40 million. The notes are convertible into cash or shares, with a conversion price of approximately $6.96 per share, a 30% premium over the closing stock price. Proceeds, estimated at $194 million, will be used for commercializing belumosudil for chronic graft-versus-host disease and other corporate purposes.
