On May 7, 2020 Kadmon Holdings, Inc. (NYSE:KDMN) reported financial and operational results for the first quarter of 2020 (Press release, Kadmon, MAY 7, 2020, View Source [SID1234557409]).

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"We made encouraging progress this past quarter, having completed our pre-NDA meeting with the FDA. Based on the feedback we have received from the Agency to date, we are confident that our proposed data package will be sufficient to support a submission of KD025 for the treatment of patients with cGVHD in the fourth quarter of this year, as previously guided. We continue to expect to announce topline results from the six-month primary analysis of our pivotal trial of KD025 in cGVHD in the second quarter of 2020, which will include an updated look at Overall Response Rate and safety, as well as initial data on duration of response," said Harlan W. Waksal, M.D., President and CEO of Kadmon.

Dr. Waksal continued, "Although our near-term goal of advancing KD025 in cGVHD remains on target, we are experiencing COVID-19-related delays in enrollment in the ongoing Phase 2 study of KD025 in systemic sclerosis as well as a delay in the initiation of the clinical trial in KD033, our immuno-oncology fusion protein. We continue to monitor the situation at hand in order to attain a better understanding of new timelines within these studies."

Dr. Waksal concluded, "We continue to prioritize the health and safety of our employees and patients as we manage the impact of COVID-19. We have implemented measures including work-from-home directives, while maintaining our operations. In these unprecedented times, the steps we are taking position the Company to continue to advance our pipeline of product candidates."

2020 Anticipated Key Clinical Milestones:

KD025

Announce topline results (updated Overall Response Rate and safety data as well as initial data on duration of response) from primary analysis of KD025-213, the pivotal trial in chronic graft-versus-host disease (cGVHD), conducted six months after completion of enrollment, in the second quarter of 2020; additional secondary endpoints, including failure-free survival and overall survival, will be submitted for presentation at an upcoming medical meeting
Submit New Drug Application (NDA) for KD025 in cGVHD to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2020
Continue enrollment in ongoing Phase 2 clinical trial in systemic sclerosis (KD025-209); enrollment is delayed due to the COVID-19 pandemic
KD033

Previously guided to initiate clinical trial of KD033, Kadmon’s anti-PD-L1/IL-15 fusion protein, in the second quarter of 2020; enrollment is delayed due to the COVID-19 pandemic
KD045

Continue ongoing Investigational New Drug Application (IND)-enabling activities of KD045, Kadmon’s next-generation ROCK inhibitor for the treatment of fibrotic diseases
Financial Results

First Quarter 2020 Results

Loss from operations for the three months ended March 31, 2020 was $16.1 million, compared to $22.7 million for the same period in 2019.

The decrease in loss from operations was primarily due to $6.0 million of license revenue recognized by the Company during the three months ended March 31, 2020 related to the strategic partnership with Meiji Seika Pharma Co., Ltd.

Liquidity and Capital Resources

At March 31, 2020, the Company’s cash and cash equivalents totaled $120.0 million, compared to $139.6 million at December 31, 2019. In addition, as of March 31, 2020, the Company held approximately 2.1 million ordinary shares of MeiraGTx Holdings plc (Nasdaq: MGTX), a clinical-stage gene therapy company, with a fair value of $28.2 million.

About KD025

KD025 is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates immune response as well as fibrotic pathways. KD025 is being studied in an ongoing pivotal trail in cGVHD as well as an ongoing Phase 2 clinical trial in adults with diffuse cutaneous systemic sclerosis (KD025-209). The FDA has granted Breakthrough Therapy Designation to KD025 for the treatment of patients with cGVHD after failure of two or more prior lines of systemic therapy. The FDA has also granted Orphan Drug Designation to KD025 for the treatment of patients with cGVHD.