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Histogen Inc. (Symbol: HSTO) is a regenerative medicine company utilizing naturally-produced products derived from newborn fibroblasts grown in a proprietary bioreactor. They focus on two primary product families: a proprietary liquid complex rich in embryonic-like proteins and growth factors, and a human extracellular matrix (ECM) material named Exceltrix. These products aim to harness the body's natural healing processes for therapeutic applications.
Despite its innovative approach, Histogen has recently faced significant challenges. On April 18, 2024, the company announced that it had filed for voluntary petitions for relief under subchapter V of Chapter 11 of the U.S. Bankruptcy Code. This filing is part of a plan to liquidate the company and distribute all value to its stakeholders. The decision follows the cessation of further development announced on September 18, 2023, where the company indicated its intention to seek approval for a Plan of Dissolution.
Histogen's journey reflects its commitment to pioneering treatments for various medical conditions. However, the strategic shift towards liquidation signifies the company's current financial predicament. Legal counsel for this process is provided by DLA Piper, LLP, with Armanino LLP serving as financial advisor.
In summary, Histogen Inc. represents a significant endeavor in the field of regenerative medicine, though its recent developments mark a pivotal change in its operational trajectory. The company’s products and research have contributed valuable insights into therapeutic applications, despite the economic hurdles encountered.
Histogen Inc. (NASDAQ: HSTO) announced positive results from its Phase 1 study of emricasan in mild symptomatic COVID-19 patients, demonstrating safety and tolerability, with no serious adverse events reported. The study showed that patients receiving emricasan experienced a complete resolution of COVID-19 symptoms such as cough and fatigue by day 7, continuing through day 45. Notably, clinical biomarkers also improved significantly in the active treatment group. Histogen aims to develop emricasan as a therapeutic option for COVID-19 and other viral inflammatory diseases.
Histogen Inc. (HSTO) announced the closing of a registered direct offering of 5,977,300 shares at $1.10 each, generating approximately $6.5 million in gross proceeds. In a concurrent private placement, the company issued unregistered warrants to purchase 4,781,840 shares at $1.00 per share. The funds will be used for working capital, clinical development of its pipeline programs, and general corporate purposes. The offering adheres to Nasdaq rules and the shares are available through a registered prospectus. H.C. Wainwright & Co. served as the placement agent.
Histogen Inc. (Nasdaq: HSTO) announced a registered direct offering of 5,977,300 shares at $1.10 each, expected to close by June 9, 2021. Concurrently, the company will issue unregistered warrants for the purchase of 4,781,840 shares. The gross proceeds are approximately $6.5 million, earmarked for working capital, clinical development expenses, and general corporate purposes. H.C. Wainwright & Co. serves as the placement agent. The shares are offered via a shelf registration statement previously filed with the SEC.
Histogen Inc. (NASDAQ: HSTO) has shifted its focus to developing orthopedic product candidates within its regenerative medicine technology platform. The company will suspend the development of HST 001 due to high resource requirements despite favorable safety results. It is on track to initiate the Phase 1/2 trial for HST 003 in June 2021, targeting cartilage regeneration in the knee. Additionally, HST 004 is moving forward with IND enabling activities for spinal disc repair, while top-line data for emricasan in mild COVID-19 patients is expected in June 2021.
Histogen Inc. (NASDAQ: HSTO) and Amerimmune, LLC released a study indicating the potential effectiveness of emricasan in treating COVID-19, published in Allergy. Research highlights elevated caspase levels in patients, particularly those with comorbidities, during both acute and long-haul phases of the disease. Emricasan, a pan-caspase inhibitor, showed promise in reducing caspase expression in vitro. The ongoing Phase 1 Study at SUNY Downstate aims to assess emricasan's efficacy in symptomatic COVID-19 patients, with results expected in Q2 2021.
Histogen Inc. (HSTO) reported a 56% revenue decline in Q1 2021, with revenues of $0.4 million compared to $1.0 million in Q1 2020. Despite this, the company has bolstered its balance sheet with $20.8 million from financing and warrant exercises. Histogen initiated a Phase 1 study of Emricasan for symptomatic COVID-19 patients, with top-line data expected in Q2 2021. The company is also set to begin a Phase 1/2 study of HST-003 for knee cartilage regeneration. New board members, Dr. Windham-Bannister and Rochelle Fuhrmann, bring valuable industry experience.
Histogen Inc. (NASDAQ: HSTO) has announced the release date for its second-quarter financial results, which will be shared post-market on May 13, 2021. The company is focused on developing first-in-class restorative therapeutics utilizing its innovative technology platform and proprietary manufacturing process. Their therapies target various indications including hair growth and joint regeneration, enhancing biological function through hypoxia-induced multipotent cells.
Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company, announced that CEO Richard W. Pascoe will present at the 20th Annual Needham Virtual Healthcare Conference. The presentation is scheduled for April 13, 2021, at 3:00 p.m. Eastern Time. A live webcast will be available, with a replay lasting 90 days on the company's Investors page. Histogen focuses on developing first-in-class restorative therapeutics aimed at enhancing the body's ability to repair itself, utilizing innovative technology involving cell-conditioned media and extracellular matrix materials.
Histogen Inc. (NASDAQ: HSTO) appointed Rochelle Fuhrmann as the new Board Chairperson and Audit Committee head, succeeding Stephen Chang, Ph.D., who is stepping down. Fuhrmann brings extensive experience from her role at Becton Dickinson and a strong financial background in the pharmaceutical sector. This leadership change is aimed at strengthening Histogen's growth trajectory as a public company. The company focuses on restorative therapeutics that stimulate the body’s natural healing processes, addressing various therapeutic indications.
Histogen Inc. (NASDAQ: HSTO) has initiated a Phase 1 study of emricasan for treating mild symptomatic COVID-19 patients. This double-blinded, randomized trial will enroll 40 patients to evaluate safety, tolerability, and preliminary efficacy, with topline results expected in Q2 2021. The trial is being conducted at SUNY Downstate Medical Center, focusing on various clinical measures. Emricasan, acquired during Histogen's merger with Conatus Pharmaceuticals, has shown potential in previous trials for inflammatory conditions.
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