お知らせ • Apr 19
Histogen Inc. Filed for Bankruptcy Histogen Inc. filed a voluntary petition for reorganization under Chapter 11 in the US Bankruptcy Court for the Southern District of California on April 18, 2024. The debtor listed its assets in the range of $1 million to $10 million and liabilities in the range of $0.05 million to $0.10 million. The debtor is represented by Eric D. Goldberg of DLA Piper LLP (US) and Armanino LLP as financial advisor as its legal counsel. お知らせ • Jan 05
Histogen Inc. Files Form 15 Histogen Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.0001 per share. お知らせ • Oct 06
Histogen Inc.(OTCPK:HSTO) dropped from NASDAQ Composite Index Histogen, Inc. has been removed from NASDAQ Composite Index . お知らせ • Sep 27
Nasdaq To File A Form 25-NSE with the SEC, To Remove Histogen's Securities from Listing and Registration On September 18, 2023, Histogen Inc. (the “Company”) previously announced that its board of directors (the “Board”) approved a plan of liquidation and dissolution of the Company (the “Plan of Dissolution”), subject to approval by the Company’s stockholders. The Company also announced that it had discontinued all clinical development programs and implemented a reduction in its workforce, including the termination of all employees except for two remaining employees effective September 30, 2023 (“Workforce Reduction”). In light of the Plan of Dissolution and Workforce Reduction, the Company was notified on September 26, 2023 by the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) that, based upon the Staff’s determination that the Company is a “public shell” as that term is defined in Nasdaq Listing Rule 5101, trading of the Company’s common stock will be suspended from trading at the opening of business on October 5, 2023 unless the Company timely requests a hearing before a Nasdaq Hearings Panel to address the deficiencies and present a plan to regain compliance. The Company does not plan to request a hearing and, therefore, expects that trading in the Company's stock will be suspended upon the opening of business on October 5, 2023. Thereafter, Nasdaq will file a Form 25-NSE with the SEC, which will remove the Company’s securities from listing and registration on The Nasdaq Stock Market. Nasdaq has not specified the exact date on which the Form 25-NSE will be filed. お知らせ • Sep 22
Histogen Inc.(NasdaqCM:HSTO) dropped from S&P TMI Index Histogen Inc.(NasdaqCM:HSTO) dropped from S&P TMI Index お知らせ • Sep 19
Histogen Intends to File Certificate of Dissolution, Delist its Shares of Common Stock from The Nasdaq Capital Market Histogen Inc. announced that its board of directors, after extensive consideration of potential strategic alternatives, has approved and adopted a Plan of Dissolution (‘Plan of Dissolution’) that would include the distribution of remaining cash to stockholders following an orderly wind down of the company’s operations, including any proceeds from the potential sale of any pipeline assets. In order to reduce costs and in connection with the Plan of Dissolution, the company has discontinued all clinical development programs and reduced its workforce, including the anticipated termination of most employees by the end of September. ‘The Board of Directors and management devoted substantial time and effort in identifying and pursuing various opportunities, but we were unable to complete a transaction that would allow us the potential to enhance stockholder value,’ stated Steven J. Mento, Ph.D., President and Chief Executive Officer of Histogen. On September 18, 2023, Histogen’s board of directors approved the liquidation and dissolution of the company pursuant to the Plan of Dissolution, subject to stockholder approval. The company intends to call a special meeting of its stockholders in the fourth quarter of 2023 to seek approval of the Plan of Dissolution and will file proxy materials with the Securities and Exchange Commission (‘SEC’) as soon as practicable. The Plan of Dissolution contemplates an orderly wind down of Histogen’s business and operations. If Histogen’s stockholders approve the Plan of Dissolution, Histogen intends to file a certificate of dissolution, delist its shares of common stock from The Nasdaq Capital Market, satisfy or resolve its remaining liabilities and obligations, including but not limited to contingent liabilities and claims and costs associated with the dissolution, make reasonable provisions for unknown claims and liabilities, attempt to convert all of its remaining assets into cash, and make distributions to its stockholders of any remaining cash available for distribution based upon their proportionate ownership at the time of the filing of the certificate of dissolution, subject to applicable legal requirements. Upon the filing of the certificate of dissolution, Histogen intends to cease trading in its common stock, close its stock transfer books and discontinue recording transfers of shares of its capital stock, in accordance with applicable law. Histogen currently expects that its existing capital resources together with the anticipated net proceeds from any sale of pipeline assets will enable it to meet its remaining liabilities and obligations with sufficient reserves. The amount actually distributable, however, may vary substantially from any estimate provided by the company based on a number of factors. お知らせ • Jun 06
Histogen Receives Letter from the Listing Qualifications Department of the Nasdaq Regarding Listing Rule 5550(a)(2) On June 5, 2023, Histogen Inc. received a letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) indicating that, based upon the closing bid price of the Company’s common stock for the 30 consecutive business day period between April 21, 2023, through June 2, 2023, the Company did not meet the minimum bid price of $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). The letter also indicated that the Company will be provided with a compliance period of 180 calendar days, or until December 4, 2023 (the “Compliance Period”), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A). In order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s common stock must maintain a minimum closing bid price of $1.00 for at least ten consecutive business days during the Compliance Period. In the event the Company does not regain compliance by the end of the Compliance Period, the Company may be eligible for additional time to regain compliance. To qualify, the Company will be required to meet the continued listing requirement for the market value of its publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split if necessary. If the Company meets these requirements, the Company may be granted an additional 180 calendar days to regain compliance. However, if it appears to Nasdaq that the Company will be unable to cure the deficiency, or if the Company is not otherwise eligible for the additional cure period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The letter has no immediate impact on the listing of the Company’s common stock, which will continue to be listed and traded on The Nasdaq Capital Market, subject to the Company’s compliance with the other listing requirements of The Nasdaq Capital Market. Although the Company will use all reasonable efforts to achieve compliance with Rule 5550(a)(2), there can be no assurance that the Company will be able to regain compliance with that rule or will otherwise be in compliance with other listing criteria of The Nasdaq Capital Market. お知らせ • Jan 04
Histogen Inc. Hires Alfred P. Spada as Chief Scientific Officer Histogen Inc. announced the appointment of Alfred P. Spada Ph.D. as Chief Scientific Officer. Alfred P. Spada, Ph. D. is a seasoned veteran of pharmaceutical discovery and development with over 35 years of combined experience in large Pharma and Biotech. Dr. Spada most recently served as President and CEO of Aya Biosciences focused on the discovery and development of novel therapies for the treatment of severe neuropsychiatric disorders where he identified the company’s orally active clinical candidate and completed necessary IND-enabling studies to position the asset for clinical evaluation. Prior to joining Aya Biosciences, Dr. Spada was co-founder, EVP of R&D and CSO of Conatus Pharmaceuticals until its merger with Histogen in May 2020. At Conatus, Dr. Spada was responsible for the management of all preclinical and safety activities and assisted in the generation of IND packages and presentations to support the company’s clinical assets. Prior to Conatus, Dr. Spada was the VP of Preclinical and Pharmaceutical Development at Idun Pharmaceuticals until its acquisition by Pfizer in 2005 and prior to Idun, the Director of Chemistry in the United States for Rhone-Poulenc Rorer and Aventis Pharmaceuticals. Dr. Spada received his Ph.D. in organic chemistry from MIT and conducted post-doctoral studies at Yale. Dr. Spada holds a BS in chemistry from Worcester Polytechnic Institute. お知らせ • Jul 29
Histogen Inc. to Report Q2, 2022 Results on Aug 11, 2022 Histogen Inc. announced that they will report Q2, 2022 results After-Market on Aug 11, 2022 お知らせ • Jul 13
Histogen Inc. announced that it expects to receive $5 million in funding Histogen Inc. announced that it has entered into a securities purchase agreement with a single healthcare-focused institutional investor for the issue of 1,774,309 common shares, Series A warrants to purchase up to an aggregate of 1,774,309 common shares and Series B warrants to purchase up to an aggregate of 1,774,309 common shares, for $2.818 per common share (or pre-funded warrant) for aggregate gross proceeds of nearly $5,000,000 on July 12, 2022. Each common share was sold with a Series A warrant to purchase one common share and a Series B warrant to purchase one common share. The Series A warrants have an exercise price of $2.568 per share and will be exercisable immediately upon issuance for a period of five and one-half years from the date of issuance. The Series B warrants have an exercise price of $2.568 per share, will be exercisable commencing immediately upon issuance for a period of eighteen months from the date of issuance. The closing of the offering is expected to occur on or about July 15, 2022, subject to the satisfaction of customary closing conditions. The shares are being sold and issued without registration under the Securities Act of 1933, as amended, in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering and Rule 506 of Regulation D promulgated under the Securities Act as sales to accredited investors, and in reliance on similar exemptions under applicable state laws. お知らせ • Jun 03
Histogen Announces 1-for-20 Reverse Stock Split Histogen Inc. announced that its Board of Directors has approved a 1-for-20 reverse stock split of the Company's issued and outstanding common stock (the Reverse Stock Split). The principal purpose of the Reverse Stock Split is to decrease the total number of shares of common stock outstanding and proportionately increase the market price of the common stock in order to meet the continuing listing requirements of The Nasdaq Capital Market. In connection with the Reverse Stock Split, the Company's CUSIP number will change to 43358Y202 as of June 3, 2022. The Company's common stock will continue to trade under the symbol HSTO. Reported Earnings • May 14
First quarter 2022 earnings released: US$0.013 loss per share (vs US$0.14 loss in 1Q 2021) First quarter 2022 results: US$0.013 loss per share (up from US$0.14 loss in 1Q 2021). Revenue: US$3.76m (up US$3.32m from 1Q 2021). Net loss: US$673.0k (loss narrowed 84% from 1Q 2021). Over the next year, revenue is expected to shrink by 68% compared to a 36% growth forecast for the industry in Germany. お知らせ • Apr 22
Histogen Inc., Annual General Meeting, Jun 01, 2022 Histogen Inc., Annual General Meeting, Jun 01, 2022, at 08:00 Pacific Standard Time. Agenda: To elect three directors to serve as Class III directors for a three-year term to expire at the 2025 annual meeting of stockholders; to approve an amendment to the Company's amended and restated certificate of incorporation to effect a reverse stock split of the Company's common stock, within a range, as determined by the Company's board of directors, of one new share for every five (5) to twenty (20) (or any number in between) shares outstanding (the Reverse Stock Split"), the implementation and timing of which shall be subject to the discretion of the Company's board of directors; to consider and vote upon the ratification of the selection of Mayer Hoffman McCann P.C. ( MHM) as independent registered public accounting firm for the fiscal year ending December 31, 2022; and to transact such other business as may be properly brought before the meeting or any adjournment or postponement thereof. Reported Earnings • Mar 12
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: US$0.39 loss per share (up from US$2.08 loss in FY 2020). Net loss: US$15.0m (loss narrowed 20% from FY 2020). Revenue was in line with analyst estimates. Over the next year, revenue is expected to shrink by 100% compared to a 76% growth forecast for the pharmaceuticals industry in Germany. お知らせ • Mar 06
Histogen Inc. to Report Q4, 2021 Results on Mar 10, 2022 Histogen Inc. announced that they will report Q4, 2021 results After-Market on Mar 10, 2022 お知らせ • Feb 17
Histogen Not Regained Compliance with the Minimum Bid Price Requirement As previously disclosed, on August 18, 2021, Histogen Inc. (the “Company”) received a letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) indicating that, based upon the closing bid price of the Company’s common stock for the 30 consecutive business day period between July 7, 2021, through August 17, 2021, the Company did not meet the minimum bid price of $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). The letter indicated that the Company will be provided with a compliance period of 180 calendar days, or until February 14, 2022 (the “Compliance Period”), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A) by having the Company’s common stock meet a minimum closing bid price of at least $1.00 for at least ten consecutive business days during the Compliance Period. As of February 14, 2022, the Company had not regained compliance with the minimum bid price requirement. However, the Company was granted an additional 180 calendar day period, or until August 15, 2022, to regain compliance (the “Second Compliance Period”) based upon the Company’s written notice provided to Nasdaq of its intention to cure the deficiency during the Second Compliance Period, by effecting a reverse stock split if necessary. There continues to be no immediate impact on the listing of the Company’s common stock, which will continue to be listed and traded on The Nasdaq Capital Market, subject to the Company’s compliance with the other listing requirements of The Nasdaq Capital Market. Although the Company will use all reasonable efforts to achieve compliance with Rule 5550(a)(2), there can be no assurance that the Company will be able to regain compliance with that rule or will otherwise be in compliance with other listing criteria of The Nasdaq Capital Market. お知らせ • Dec 22
Histogen Inc. announced that it has received $3.500001 million in funding On December 21, Histogen Inc closed the transaction. お知らせ • Dec 17
Histogen Inc. announced that it expects to receive $3.500001 million in funding Histogen Inc. announced that it has entered into a Securities Purchase Agreement with several institutional and accredited investors for the issue of 8,235,297 shares at par value of $0.0001 per share at a price of $0.425 for the gross proceeds of $3,500,001 on December 15, 2021. The company also issued 8,235,297 warrants in the transaction. Subject to certain ownership limitations, the Warrants will become exercisable beginning six months and one day after the issuance date at an exercise price equal to $0.425 per share of Common Stock, subject to adjustments as provided under the terms of the Warrants. The Warrants have a term of five and one-half years from the issuance date. The transaction is expected to be closed by December 20, 2021, subject to the satisfaction of customary closing conditions. The Shares, the Warrants, and the shares issuable upon exercise of the Warrants are being sold and issued without registration under the Securities Act of 1933, as amended (the “Securities Act”), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering and Rule 506 of Regulation D promulgated under the Securities Act as sales to accredited investors, and in reliance on similar exemptions under applicable state laws. Reported Earnings • Nov 16
Third quarter 2021 earnings released: US$0.092 loss per share (vs US$0.27 loss in 3Q 2020) Third quarter 2021 results: Net loss: US$3.84m (loss widened 18% from 3Q 2020). お知らせ • Jul 01
Histogen Announces Initiation of HST 003 Phase 1/2 Trial for Knee Cartilage Regeneration Histogen Inc. announced the initiation of its Phase 1/2 clinical trial of HST 003 to evaluate the safety and efficacy of human extracellular matrix implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. Clinical sites participating in the trial include: OasisMD in San Diego, CA, The Steadman Clinic in Vail, CO and Walter Reed Medical Center in Bethesda,
MD. お知らせ • Jun 23
Histogen Inc. and its partner Amerimmune LLC Announce Positive Top-Line Study Results from its Phase 1 Study of Emricasan in Mild Symptomatic COVID-19 Patients Histogen Inc. and its partner Amerimmune LLC, announced top line results from its Phase 1 study of emricasan in mild symptomatic COVID-19 patients to assess safety, tolerability, and preliminary efficacy. The study demonstrated that emricasan was safe and well tolerated during the 14 days of dosing and at the day 45 follow-up, as compared to placebo with no reports of serious adverse events. Patients who completed treatment with emricasan had a complete resolution of the symptoms most commonly associated in mild COVID-19, such as cough, headache and fatigue at day 7 and continued through day 45. Patients in the placebo arm who completed the study did not experience COVID-19 symptom resolution at any time point out to day 45. In addition, a number of very important observations were made related to clinical outcomes, laboratory findings and drug target related biomarkers. These improvements were seen in all subjects in the active drug group that showed decreases in caspase biomarkers, whereas patients in placebo group continued to have COVID-19 related symptoms and laboratory findings. お知らせ • Jun 10
Histogen Inc. has completed a Follow-on Equity Offering in the amount of $6.57503 million. Histogen Inc. has completed a Follow-on Equity Offering in the amount of $6.57503 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,977,300
Price\Range: $1.1
Discount Per Security: $0.077
Transaction Features: Registered Direct Offering お知らせ • Jun 04
Histogen Provides Update on its Development Programs and Pipeline Focus Histogen Inc. announced an update on its pipeline focus following a strategic evaluation of its regenerative medicine platform technology development programs with the goal of focusing on high value orthopedic indications, creating pipeline synergies and maximizing resources in an effort to further drive long-term shareholder value. HST 001 – they completed their strategic evaluation of the HST 001 program taking into consideration the results from their Phase 1b/2a clinical trial of HST 001 as announced earlier this year, and as a result, they will suspend development of this program. While HST 001 has demonstrated a favorable safety and tolerability profile in androgenic alopecia in men, the development resources required to potentially achieve an acceptable efficacy threshold are substantial in terms of cost and time. Therefore, believe the best business decision at this time, is to redirect these resources towards high value orthopedic programs. HST 003 - are on track to initiate Phase 1/2 clinical study of HST 003 in June 2021. The upcoming study is designed to evaluate the safety and efficacy of human extracellular matrix (hECM) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. Patients will be enrolled at three sites: Oasis MD in San Diego, CA, The Steadman Clinic in Vail, CO, and Walter Reed Medical Center in Bethesda, MD. HST 004 - recently initiated an investigational new drug application (IND) enabling activities for HST 004, a CCM solution intended to be administered through an intradiscal injection for spinal disc repair. Its initial preclinical research has shown that HST 004 stimulates stem cells from the spinal disc to proliferate and secrete aggrecan and collagen II, regenerate normal matrix and cell tissue structure, and restore disc height. HST 004 was also shown to both reduce inflammation and protease activity and upregulate aggrecan production in an ex vivo spinal disc model. It anticipate filing an IND in the second half of 2022. Emricasan – In May, we, along with partner Amerimmune, completed enrollment of the Phase 1 study of emricasan for the treatment of mild-symptomatic COVID-19 patients. A total of 13 patients have been enrolled at single site in New York City versus the initially targeted 40 patients. The decision to stop enrollment with a lesser number of patients was based solely upon the overall decline in COVID-19 cases in New York City and its negative impact on patient recruitment. To date, there have been no reports of serious adverse events, and anticipate top-line safety, biomarker and patient reported outcomes data to be available in June 2021. お知らせ • May 21
Histogen and Amerimmune Reports Publication on Emricasan in COVID-19 Histogen Inc. and its partner, Amerimmune, LLC reported the publication of the potential utility of emricasan in COVID-19 in Allergy, the official Journal of the European Academy of Allergy and Clinical Immunology. Amerimmune, in collaboration with Dr. Raavi Gupta from SUNY Downstate Medical Center and Dr. Lishomva Ndhlovu from Weill Cornell Medicine, demonstrated the impact of caspases in multiple blood cells beyond the acute stage of the disease. Their research concluded that caspases are elevated in patients with co-morbidities and persisted into much later stages of the disease, also referred to as long COVID. Moreover, the results were not just limited to the elevation of caspase-1 in white blood cells. There was also an elevation of caspase-3 in red blood cells (erythrocytes). These findings have potential implications to understand the pathogenesis of complications of SARS-CoV2 infection such as extensive blood clot formation, resulting in significant morbidity and mortality. The collaborative work of SUNY Downstate and Weill Cornell Medical Center with Amerimmune demonstrated how in certain individuals regarded as “high risk”, such as asthma, immune deficiencies and chronic sinopulmonary disease, there is already increased baseline caspase-1 expression, potentially setting the stage for complications if they were to be infected with SARS CoV2. All the assays used in this study were developed and validated by Amerimmune. This study now leads to more research opportunities to explore why some individuals develop worse outcomes, whereas some others remain asymptomatic. Most importantly, the team showed that Emricasan, a pan-caspase inhibitor, can effectively reduce the caspase expression in vitro, paving the way to the use of pan-caspase inhibition as a treatment modality in COVID-19. About Emricasan: Emricasan is a potential first-in-class, orally active, pan-caspase inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Histogen acquired certain rights to emricasan and other caspase inhibitor compounds as a part of its merger with Conatus Pharmaceuticals Inc. in 2020. Histogen believes that by reducing the activity of these enzymes, caspase inhibitors have the potential to interrupt the progression of a variety of diseases. To date, emricasan has been studied in over 950 patients in 19 completed clinical trials across a broad range of liver diseases. In NASH cirrhosis patients in multiple clinical Phase II trials conducted by Conatus, emricasan demonstrated rapid and sustained reductions in elevated levels of key biomarkers of inflammation and cell death. Similarly, elevated biomarkers are also believed to play a role in the severity and progression of COVID-19. Reported Earnings • May 16
First quarter 2021 earnings released: US$0.14 loss per share (vs US$0.55 loss in 1Q 2020) First quarter 2021 results: Net loss: US$4.27m (loss widened 132% from 1Q 2020). お知らせ • May 14
Histogen Provides Business Update Histogen Inc. initiated the emricasan study for treatment of mild symptomatic COVID-19 patients and are on track to initiate the HST-003 study for knee cartilage repair in the second quarter of 2021. お知らせ • Mar 17
Histogen and Amerimmune Announce First Patient Dosed in Phase 1 Study of Emricasan in Symptomatic Covid-19 Patients Histogen Inc. and Amerimmune LLC announced dosing the first patient in a Phase 1 study of emricasan in mild symptomatic -COVID-19 patients to assess safety, tolerability, and preliminary efficacy. SUNY Downstate Medical Center in Brooklyn, New York, has been selected as the single site for the study conduct. This double blinded, 1:1 randomized, placebo controlled single site study is expected to enroll 40 symptomatic mild-COVID-19 patients in an outpatient setting using emricasan at 25mg BID dosing for 14 days versus placebo. The study is designed to assess safety and tolerability and will also include various clinical and laboratory measures and patient reported outcomes (PROs) using the FDA COVID-19 Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Assessment tool. お知らせ • Mar 16
Histogen Announces Removal of Clinical Hold by FDA for HST-003 IND to Initiate a Phase 1/2 Trial for Knee Cartilage Regeneration Histogen Inc. announced that the U.S. Food and Drug Administration (“FDA”) has confirmed that the Company satisfactorily addressed all clinical hold questions and can proceed with initiation of the planned Phase 1/2 clinical trial of HST-003 to evaluate the safety and efficacy of human extracellular matrix (hECM:HST-003) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. It is anticipated that clinical sites participating in the trial will include: OasisMD in San Diego, CA, The Steadman Clinic in Vail, CO and Walter Reed Medical Center in Bethesda, MD. About HST-003: Histogen’s human extracellular matrix, or hECM, is intended for regenerating hyaline cartilage for the treatment of articular cartilage defects with a novel malleable scaffold that stimulates the body’s own stem cells. In multiple preclinical models, HST-003 has been shown to regenerate mature cartilage and well vascularized bone, indicating great therapeutic potential in the sports medicine, spinal disc repair, orthopedic, and dental areas. Studies conducted by outside experts have demonstrated that HST-003 is anti-inflammatory, angiogenic, and can stimulate the growth of stem cells in damaged areas to induce tissue regeneration. The most extensive in vivo work in animals has focused on the regeneration of new hyaline cartilage and bone in full thickness knee injuries. Reported Earnings • Mar 15
Full year 2020 earnings released: US$2.08 loss per share (vs US$0.89 loss in FY 2019) The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: US$2.06m (down 82% from FY 2019). Net loss: US$18.8m (loss widened US$15.8m from FY 2019). Products in clinical trials Phase I: 2 Executive Departure • Mar 11
Independent Director has left the company On the 10th of March, Yizhuo Zhang's tenure as Independent Director ended after 4.5 years in the role. As of December 2020, Yizhuo personally held 600.98k shares (€528k worth at the time). A total of 5 executives have left over the last 12 months. お知らせ • Mar 05
Histogen Inc. to Report Q4, 2020 Results on Mar 11, 2021 Histogen Inc. announced that they will report Q4, 2020 results After-Market on Mar 11, 2021 お知らせ • Feb 18
Histogen Announces Week 26 HST-001 Study Results for the Treatment of Androgenic Alopecia in Men Histogen Inc. announced week 26 results from its Phase 1b/2a clinical trial of HST-001 in male patients with androgenic alopecia. At the week 26 timepoint, patients treated with HST-001 demonstrated statistically significant change from baseline in total hairs (terminal and vellus) in the target area (TAHC) in the vertex as measured by Canfield’s Hairmetrix macrophotography system. HST-001 was also shown to be safe and well tolerated at week 26 as compared to placebo with no reports of serious adverse events. Similar to the week 18 primary endpoint results reported in December of 2020, HST-001 did not achieve statistical significance at week 26 when compared to placebo. About the HST-001 Phase 1a/2b Study - This 2:1 randomized, blinded, placebo controlled, single site study enrolled 36 male patients with androgenic alopecia with mild to moderate hair loss on a Norwood-Hamilton (N-H) Scale (3V, 4, 5), with a total of 30 evaluable patients at week 26. It was designed to assess the safety and tolerability of HST-001, as well as indicators of efficacy at weeks 18 and 26. The primary study endpoint is absolute change from baseline versus week 18 in total hairs (terminal and vellus) in the (TAHC) of the vertex as measured by Canfield’s Hairmetrix macrophotography system. Secondary endpoints include absolute change from baseline in total hairs (terminal and vellus) new terminal and vellus hair count, hair thickness density and percent change from baseline in TAHC, terminal and vellus hair counts in the vertex and right temporal regions at weeks 18 and 26, all as measured by Canfield’s Hairmetrix macrophotography system. At each treatment timepoint (Weeks 0, 6 and 12), patients received a total of 20 injections, 10 in the vertex scalp region and 5 in each temporal region for a total dose of 2mL. HST-001, or Hair Stimulating Complex (HSC), is intended to be a physician-administered therapeutic for hair loss. HSC is anticipated to be a relatively safe, minimally invasive treatment that promotes new hair growth where existing treatments only reduce hair loss. HSC is manufactured to enrich for growth factors including KGF, VEGF and follistatin, which are involved in signaling stem cells in the body and have been shown to be important in hair formation and the stimulation of resting hair follicles. Is New 90 Day High Low • Feb 10
New 90-day high: €1.51 The company is up 8.0% from its price of €1.40 on 12 November 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 11% over the same period. お知らせ • Jan 21
Histogen Inc. Reports FDA Clinical Hold for Planned Phase 1/2 Trial of HST-003 for Knee Cartilage Regeneration Histogen Inc. announced that the U.S. Food and Drug Administration (FDA) has verbally notified the company that it has additional questions about the company’s Investigational New Drug (“IND”) application package for the planned Phase 1/2 clinical trial of HST-003, which is intended to evaluate the safety and efficacy of human extracellular matrix (hECM:HST-003) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. Histogen has not yet received the written notice of its clinical hold from the FDA, which the FDA expects to provide to the company by February 12, 2021. Based upon the verbal communication with FDA, they indicated that the clinical hold is due to pending CMC information that is required to complete their review. Histogen plans to work diligently with the FDA to seek the release of the clinical hold and provide updated guidance on any potential impact to the HST-003 program once the written notice from FDA is received. Histogen’s human extracellular matrix, or hECM, is intended for regenerating hyaline cartilage for the treatment of articular cartilage defects with a novel malleable scaffold that stimulates the body’s own stem cells. In multiple preclinical models, HST-003 has been shown to regenerate mature cartilage and well vascularized bone, indicating therapeutic potential in the sports medicine, spinal disc repair, orthopedic, and dental areas. Studies conducted by outside experts have demonstrated that HST-003 is anti-inflammatory, angiogenic, and can stimulate the growth of stem cells in damaged areas to induce tissue regeneration. The most extensive in vivo work in animals has focused on the regeneration of new hyaline cartilage and bone in full thickness knee injuries. お知らせ • Jan 06
Histogen Inc. has completed a Follow-on Equity Offering in the amount of $14 million. Histogen Inc. has completed a Follow-on Equity Offering in the amount of $14 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 11,600,000
Price\Range: $1
Discount Per Security: $0.07
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 14,000,000
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 2,400,000 Is New 90 Day High Low • Jan 05
New 90-day low: €0.63 The company is down 59% from its price of €1.55 on 07 October 2020. The German market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is flat over the same period. Is New 90 Day High Low • Dec 19
New 90-day low: €0.96 The company is down 34% from its price of €1.45 on 18 September 2020. The German market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 9.0% over the same period. お知らせ • Dec 19
Histogen Inc. Announces Filing an Investigational New Drug Application for HST-003 Histogen Inc. announced that it has submitted an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration for the initiation of a Phase 1/2 clinical trial of HST-003 to evaluate the safety and efficacy of human extracellular matrix (hECM:HST-003) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. It is anticipated that clinical sites participating in the trial will include: OasisMD in San Diego, CA, The Steadman Clinic in Vail, CO and Walter Reed Medical Center in Bethesda, MD. Is New 90 Day High Low • Dec 03
New 90-day low: €1.06 The company is down 29% from its price of €1.51 on 04 September 2020. The German market is up 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 11% over the same period. お知らせ • Dec 02
Histogen Announces Preliminary Week 18 HST-001 Study Results for the Treatment of Androgenic Alopecia in Men Histogen Inc. announced preliminary week 18 results from its Phase 1b/2a clinical trial of HST-001 in male patients with androgenic alopecia. At the week 18 primary efficacy endpoint, patients treated with HST-001 demonstrated separation from placebo patients for absolute change from baseline in total hairs (terminal and vellus) in the target area (TAHC) in the vertex as measured by Canfield’s Hairmetrix macrophotography system. HST-001 was also shown to be safe and well tolerated at week 18 as compared to placebo with no reports of serious adverse events. While HST-001 did not achieve statistical significance at the week 18 primary endpoint assessment, the company is encouraged that these results demonstrated separation from placebo and that patients treated with HST-001 grew new hairs in the vertex region of the scalp while placebo patients lost hairs in the same region during the 18 week evaluation period the company look forward to completing the study and reporting the final results from the week 26 assessments, along with plans for further clinical development of HST-001, in early first quarter of 2021. お知らせ • Nov 17
Histogen Inc. has completed a Follow-on Equity Offering in the amount of $4.500016 million. Histogen Inc. has completed a Follow-on Equity Offering in the amount of $4.500016 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,522,784
Price\Range: $1.78375
Discount Per Security: $0.12486
Transaction Features: Registered Direct Offering お知らせ • Oct 30
Histogen Inc. to Report Q3, 2020 Results on Nov 12, 2020 Histogen Inc. announced that they will report Q3, 2020 results at 5:00 PM, Eastern Standard Time on Nov 12, 2020 お知らせ • Oct 29
Histogen Inc. and Amerimmune Llc Enters into A Collaborative Development and Commercialization Agreement for Emricasan in the Treatment of Covid-19 Histogen Inc. announced entering 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. Additionally, Histogen has received Investigational New Drug (IND) approval from the United States Food and Drug Administration to initiate a Phase 1 study of emricasan in mild-COVID-19 patients to assess safety and tolerability. Amerimmune, which will lead the development efforts of emricasan, 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. 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. お知らせ • Oct 20
Histogen Inc. Appoints Moya Daniels as Executive Vice President and Head of Regulatory, Quality and Clinical Operations Histogen Inc. announced the appointment of Moya Daniels as Executive Vice President and Head of Regulatory, Quality and Clinical Operations. Ms. Daniels most recently served as Senior Vice President of GMP Quality at SanBio, where she successfully led the CMC regulatory development and GMP Quality function in support of the planned Japan commercialization of their lead product candidate. Prior to SanBio, Ms. Daniels was the Senior Vice President of Regulatory Affairs and Global Quality Assurance at Orchard Therapeutics, where she led the company's CMC regulatory and GXP quality strategy and was part of the team that led the in-licensing of GSK's rare disease gene therapy portfolio. Prior to joining Orchard, Ms. Daniels served as Vice President of Regulatory Affairs and Quality Assurance at Fate Therapeutics, Inc, where she led the development of the global regulatory strategy and quality assurance function and was interim head of Clinical Operations. お知らせ • Oct 06
Histogen Announces Completion of Final Dosing Timepoint Milestone in its 1b/2a Trial for Androgenic Alopecia in Men Histogen Inc. announced completion of patient dosing in its Phase 1b/2a clinical trial of HST-001, designed to assess the safety, tolerability and indicators of efficacy of HST-001 for the treatment of androgenic alopecia in men. This blinded, randomized, placebo controlled, single site study has enrolled 36 subjects with male pattern hair loss using a 2:1 randomization of HST-001 to placebo. It is designed to assess the safety and tolerability of HST-001, as well as indicators of efficacy including non-vellus hair count, total hair count, and hair thickness density as measured by Canfield macrophotography. At each treatment timepoint (Weeks 0, 6 and 12), subjects will receive a total of 20 injections, 10 in the vertex scalp region and 5 in each temporal recession region, the most common areas of hair loss in men with androgenic alopecia. Primary and secondary endpoints will be assessed at Week 18. Top-line data is anticipated to be available in the fourth quarter of 2020. お知らせ • Sep 30
Histogen Announces Update for its HST-002 Dermal Filler Program Histogen Inc. announced that it received communications from the Office of Combination Products (OCM), a division of the United States Food and Drug Administration (FDA), that HST-002 is a drug-biologic-device combination product and will be assigned to the Center for Biologics Evaluation Research (CBER) Office of Tissues and Advanced Therapies (OTAT) as the agency lead for premarket review and regulation. In April of 2020, Histogen had submitted an IDE (Investigational Device Exemption) application for HST-002 based upon its primary mechanism of action and historical regulatory precedence for approved dermal fillers. Is New 90 Day High Low • Sep 23
New 90-day low: €1.31 The company is down 66% from its price of €3.88 on 25 June 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 2.0% over the same period. お知らせ • Sep 17
Histogen Inc. Announces Phase 1/2 Clinical Trial Designed to Evaluate HST-003 Histogen Inc. has been 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. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702, is the awarding and administering acquisition office. 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. Histogen’s HST-003 has demonstrated hyaline cartilage regeneration in three different in vivo animal models conducted by orthopedic experts. It is an honor to have been granted an award from the DoD to support HST-003 Phase 1/2 trial,” concluded Dr. Naughton. There is a significant need for improved acute knee injury treatments in both military and civilian populations. Approximately 900,000 Americans are affected by knee cartilage injuries annually, with 200,000 requiring surgical interventioni. Further, among US military personnel, musculoskeletal injuries are a leading cause of morbidity, lost training time and reduced operational readiness, resulting in as many as 2.4 million health visits and 25 million limited-duty days per year. お知らせ • Aug 01
Histogen Inc. to Report Q2, 2020 Results on Aug 13, 2020 Histogen Inc. announced that they will report Q2, 2020 results at 5:00 PM, Eastern Standard Time on Aug 13, 2020 