On March 5, 2020 Kadmon Holdings, Inc. (NYSE: KDMN) reported financial and operational results for the fourth quarter and full year ended December 31, 2019 (Press release, Kadmon, MAR 5, 2020, View Source [SID1234555279]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We achieved significant progress in 2019, led by positive results from the interim analysis of the pivotal trial of KD025 in cGVHD that greatly exceeded the threshold for success, achieving overall response rates of 64% and 67% with KD025 200 mg QD and 200 mg BID, respectively; we also recently presented detailed efficacy and safety data from this trial, further underscoring the therapeutic potential of KD025 in this indication," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We will meet with the FDA later this month to discuss our planned NDA submission of KD025 and expect to provide an update of that meeting, along with topline results from the primary analysis of the pivotal trial, in the second quarter of 2020. Finally, we raised approximately $123 million and fully paid off our term debt in the fourth quarter of 2019, strengthening our financial position and ability to execute on our anticipated milestones."
2020 Anticipated Key Clinical Milestones:
KD025
Hold pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) in March 2020 to discuss regulatory pathway for KD025 in chronic graft-versus-host disease (cGVHD); provide an update on the meeting in the second quarter of 2020
Announce topline results from primary analysis of pivotal trial in cGVHD (KD025-213) in the second quarter of 2020
Complete enrollment in ongoing Phase 2 clinical trial in systemic sclerosis (KD025-209)
KD033
Initiate clinical trial of KD033, Kadmon’s anti-PD-L1/IL-15 fusion protein for the treatment of solid tumors, in the second quarter of 2020
KD045
Continue ongoing Investigational New Drug Application (IND)-enabling activities of KD045, Kadmon’s next-generation ROCK inhibitor for the treatment of fibrotic diseases
Q4 2019 Key Business Highlights:
Closed underwritten public offering of 29.9 million shares of common stock for gross proceeds of $101.6 million, including full exercise of the underwriters’ option to purchase additional shares
Divested 1.4 million ordinary shares of MeiraGTx Holdings plc (MGTX), bringing $22 million in net proceeds
Paid off term debt in full; the Company no longer maintains any term debt obligations
Established strategic partnerships to develop KD025 in China and Japan with BioNova Pharmaceuticals Ltd. (BioNova) and Meiji Seika Pharma Co., Ltd., respectively
Financial Results
Fourth Quarter 2019 Results
Loss from operations for the three months ended December 31, 2019 was $18.3 million, compared to $27.8 million for the same period in 2018.
The decrease in loss from operations was primarily due to $4.0 million of license revenue recognized by the Company during the three months ended December 31, 2019 related to the BioNova strategic partnership. The decrease was also driven by a decrease in research and development expense due to timing of direct external costs associated with development of KD025 and compensation for research and development personnel.
Full Year 2019 Results
Loss from operations for the year ended December 31, 2019 was $89.1 million, compared to $85.9 million for the same period in 2018.
The increase in loss from operations was primarily due to an increase in research and development expenses for the year ended December 31, 2019 of $7.5 million, offset by $4.0 million of revenue associated with the BioNova strategic partnership. The increase in research and development expenses was primarily related to direct external costs of KD025 development.
Liquidity and Capital Resources
At December 31, 2019, the Company’s cash and cash equivalents totaled $139.6 million, compared to $94.7 million at December 31, 2018. In addition, as of December 31, 2019, the Company held approximately 2.1 million ordinary shares of MGTX, a publicly traded, clinical-stage gene therapy company.
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. In addition to the pivotal trial in cGVHD, KD025 is being studied in 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.