HISTOGEN INC - HSTO STOCK NEWS

Histogen Inc. (NASDAQ: HSTO) announced the submission of an Investigational New Drug (IND) application for HST-003, aimed at knee cartilage regeneration, anticipating a Phase 1/2 clinical trial start in Q1 2021. This follows a $2M grant from the Department of Defense to support clinical development. The trial sites will include OasisMD, The Steadman Clinic, and Walter Reed Medical Center. HST-003 aims to regenerate hyaline cartilage using a human extracellular matrix, addressing a significant need as knee injuries affect 900,000 Americans annually.

Histogen Inc. (NASDAQ: HSTO) reported preliminary results from the Phase 1b/2a clinical trial of HST-001 for androgenic alopecia. At week 18, HST-001 showed a separation from placebo in hair growth, although it did not achieve statistical significance. The treatment was found to be safe and well tolerated, with no serious adverse events reported. Final study results are expected by early Q1 2021. HST-001 aims to offer a new therapeutic option for hair loss, enriching for key growth factors essential for hair follicle stimulation.

Histogen Inc. (Nasdaq: HSTO) has completed a registered direct offering of 2,522,784 shares at $1.78375 each, raising approximately $4.5 million. The offering includes unregistered warrants for an additional 1,892,088 shares, exercisable at $1.70. Proceeds will be utilized for working capital and development of clinical programs, including CCM and HSC. The shares were offered under a previously filed registration statement. The offering was facilitated by H.C. Wainwright & Co.

Histogen Inc. (HSTO) has announced a registered direct offering of 2,522,784 shares at $1.78375 each, totaling approximately $4.5 million before fees. Concurrently, unregistered warrants for 1,892,088 shares will also be issued. The closing is expected around November 16, 2020. Proceeds will support working capital and clinical developments for their programs. H.C. Wainwright & Co. is the placement agent. The shares are offered under an effective registration statement.

Histogen (NASDAQ: HSTO) reported its Q3 2020 financials, revealing revenues of $0.5M, up from $0.3M in 2019. The company has received a $2M grant from the Department of Defense for its HST-003 cartilage regeneration trial, expected to start in Q1 2021. They are also on track to release topline data for the HST-001 trial for androgenic alopecia in Q4 2020. Histogen appointed Moya Daniels as EVP of Regulatory and Clinical Operations and entered a partnership with Amerimmune to develop emricasan for COVID-19. The company’s cash and equivalents stood at $6.6M as of September 30, 2020.

Histogen Inc. (NASDAQ: HSTO) will announce its third-quarter financial results for the period ending September 30, 2020, on November 12, 2020, after market close. The company focuses on developing first-in-class restorative therapeutics aimed at enhancing biological functions through its innovative technology platform that utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen’s applications include hair growth, dermal rejuvenation, joint cartilage regeneration, and spinal disk repair.

Histogen Inc. (NASDAQ: HSTO) received FDA IND approval to initiate a Phase 1 study of emricasan for mild COVID-19 patients to assess safety and tolerability. The study, led by Amerimmune LLC, is expected to start by the end of 2020 at major medical centers in New York City. Under a collaborative agreement, Histogen will maintain ownership and regulatory oversight of emricasan while Amerimmune will fund and develop it. The collaboration aims to leverage emricasan's potential in reducing disease severity and progression of COVID-19.

Histogen Inc. (NASDAQ: HSTO) has appointed Moya Daniels as the new Executive Vice President and Head of Regulatory, Quality, and Clinical Operations. Moya brings over 30 years of experience in biotechnology, specializing in cell and gene therapy. Previously, she held leadership roles at SanBio and Orchard Therapeutics, contributing to regulatory strategies and quality assurance. Histogen aims to advance its pipeline of therapeutic candidates, leveraging Moya's expertise. This leadership change is deemed crucial for the company's clinical progress and for enhancing regulatory oversight.

Histogen Inc. (NASDAQ: HSTO) announced the completion of patient dosing in its Phase 1b/2a trial for HST-001, aimed at treating androgenic alopecia in men. The trial involved 36 subjects and assessed safety, tolerability, and efficacy indicators. The top-line data is expected in Q4 2020. HST-001 is positioned as a potential first-in-class therapy that promotes new hair growth, differing from existing FDA-approved treatments that only reduce hair loss. Histogen's innovative technology leverages growth factors crucial for hair formation.