On November 10, 2020 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported financial results for the third quarter ended September 30, 2020 and provided an update on its clinical pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, NOV 10, 2020, View Source [SID1234570491]).
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Key Third Quarter 2020 Highlights and Subsequent Updates
Received $2M Grant Award from DoD to support the HST-003 Trial for Cartilage Regeneration in the Knee. In September, Histogen was awarded a $2 million grant by the Peer Reviewed Orthopedic Research Program (PRORP) of the U.S. Department of Defense (DoD) to help fund a Phase 1/2 clinical trial of HST-003 for regeneration of cartilage in the knee. Histogen expects to start the trial in the first quarter of 2021. The Phase 1/2 clinical trial is designed to evaluate HST-003 in combination with a microfracture procedure in 15 civilian and military patients with recent focal cartilage defects in the knee caused by injury. Patients will be enrolled at three clinical sites: OasisMD in San Diego, CA, The Steadman Clinic in Vail, CO and Walter Reed Medical Center in Bethesda, MD. In addition to safety parameters, endpoints will include traditional scores for pain and joint function from The Knee Injury and Osteoarthritis Outcome Scores (KOOS) and The International Knee Documentation Committee (IKDC), as well as an MRI to quantify cartilage regeneration. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702, is the awarding and administering acquisition office. The views expressed in this press release are those of Histogen and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
Topline Data for HST-001 Phase 1b/2a Trial for Androgenic Alopecia in Men on Track for 4Q20. Histogen announced in October that it completed dosing for week 12, the last of three dosing timepoints, in our HST-001 trial, and we remain on track to announce top line data results in the fourth quarter of this year.
Appointed Moya Daniels as Head of Regulatory, Quality and Clinical Operations. In October, Ms. Daniels joined Histogen as its Executive Vice President and Head of Regulatory, Quality and Clinical Operations. Moya brings over 30 years of experience in regulatory, quality and development in the life sciences industry to Histogen. Ms. Daniels most recently served as Senior Vice President of GMP Quality at SanBio and prior to SanBio, she held the position of Senior Vice President of Regulatory Affairs and Global Quality Assurance at Orchard Therapeutics.
Entered into a Collaborative Development and Commercialization Agreement with Amerimmune LLC to jointly develop emricasan, an orally active caspase inhibitor, for the treatment of COVID-19. Under the terms of the collaboration, Histogen will retain ownership and oversight over emricasan and responsibility for all regulatory filings and maintaining its existing caspase inhibitor patent portfolio. Amerimmune, in collaboration with Histogen, will fund and lead the emricasan development efforts and maintain its own portfolio of patents for caspase inhibition and immunotherapy. Additionally, Amerimmune has been granted an option to commercialize emricasan under certain conditions for the sole purpose of supporting future third-party partnering transactions. Should any such partnering transaction emerge, Histogen and Amerimmune will share profits equally. The parties will manage the collaboration under a joint development and partnering committee governance structure.
Received IND Approval from FDA to Initiate a Phase 1 Study of Emricasan in Mild-COVID-19 Patients. Histogen received IND approval from the FDA in October. Histogen’s partner Amerimmune will lead the development efforts for emricasan and has selected clinical sites at two major medical centers in the New York City metropolitan area to conduct the study. Amerimmune is pursuing non-dilutive funding in order to support the clinical program and anticipates initiating the Phase 1 study as early as the end of 2020.
"With our continued successful transition into a public company during the third quarter, we believe we remain on track to achieve our key strategic objectives in the fourth quarter of 2020, notably, the sharing of top-line results from our HST-001 Phase 1a/2b trial for androgenic alopecia in men, submitting the IND for HST-003, and supporting our partner, Amerimmune, in preparing for a Phase 1 study of emricasan as a potential therapeutic for the treatment of mild COVID-19 patients" said Richard W. Pascoe, Histogen’s President and Chief Executive Officer.
Financial Highlights for the Third Quarter 2020
Revenues for the three months ended September 30, 2020 and 2019, we recognized product and service revenues of $0.5 million and $0.3 million, respectively. The year-over-year increase of $0.2 million was primarily due to the fulfillment of supply orders of CCM to Allergan.
Cost of revenues for the three months ended September 30, 2020 and 2019, we recognized cost of product revenue of $0.3 million and $0.1 million, respectively. The increase of $0.2 million for the three months ended September 30, 2020 as compared to the three months ended September 30, 2019 was commensurate with the increase in product sales to Allergan.
Research and development expenses for the three months ended September 30, 2020 and 2019 were $1.5 million and $0.7 million, respectively. The increase of $0.8 million for the three months ended September 30, 2020 as compared to the three months ended September 30, 2019 was primarily due to increases related to expanded development costs of our product candidates and increases in personnel related expenses due to changes in duties and responsibilities of existing personnel.
General and administrative expenses for the three months ended September 30, 2020 and 2019 were $2.0 million and $1.2 million, respectively. The $0.8 million increase for the three months ended September 30, 2020 as compared to the three months ended September 30, 2019 was primarily due to increases in insurance, rent and legal and accounting fees, offset by decreases in personnel related expenses due to changes in duties and responsibilities of existing personnel.
Cash and cash equivalents as of September 30, 2020 were $6.6 million. The $6.6M is exclusive of any DOD grant funding which will be received only as budgeted expenses under the grant are incurred by Histogen. Histogen believes that its existing cash and cash equivalents and cash inflow from operations will be sufficient to meet Histogen’s anticipated cash needs into the second quarter of 2021.