1. SAN DIEGO, Oct. 28, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Histogen's financial results for the third quarter ended September 30, 2020 will be released after the close of market on Thursday, November 12, 2020.

    About Histogen Inc.

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned…

    SAN DIEGO, Oct. 28, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Histogen's financial results for the third quarter ended September 30, 2020 will be released after the close of market on Thursday, November 12, 2020.

    About Histogen Inc.

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen's proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

    CONTACT:

    Susan A. Knudson

    Executive Vice President & CFO

    Histogen Inc.

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  2. SAN DIEGO, Oct. 19, 2020 (GLOBE NEWSWIRE) -- 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, today announced the appointment of Moya Daniels as Executive Vice President and Head of Regulatory, Quality and Clinical Operations.

    "I am pleased to have Moya join the Histogen team at this important time as we continue to progress our pipeline candidates in the clinic," said Richard W. Pascoe, President and Chief Executive Officer of Histogen. "Moya has over 30 years of experience in the biotechnology and pharmaceutical industries and most notably has extensive expertise…

    SAN DIEGO, Oct. 19, 2020 (GLOBE NEWSWIRE) -- 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, today announced the appointment of Moya Daniels as Executive Vice President and Head of Regulatory, Quality and Clinical Operations.

    "I am pleased to have Moya join the Histogen team at this important time as we continue to progress our pipeline candidates in the clinic," said Richard W. Pascoe, President and Chief Executive Officer of Histogen. "Moya has over 30 years of experience in the biotechnology and pharmaceutical industries and most notably has extensive expertise in the cell and gene therapy field. Moreover, Moya brings an impressive track-record to Histogen as an industry leader which will complement our existing senior management team."

    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. Moya led development of the global regulatory strategy, quality, and global clinical operations at Osiris Therapeutics, which led to the approval of Prochymal®, the first approved allogeneic cell therapy indicated for the treatment of pediatric steroid refractory acute Graft Versus Host Disease in Canada and New Zealand. Ms. Daniels also held a senior leadership position at Macrocure as Vice President of Global Regulatory Affairs and currently serves as a Scientific Advisory Board member for Indapta Therapeutics.

    "I am energized by Histogen's leadership team and scientists and look forward to working with them to advance the company's technology through clinical development. Histogen's proprietary manufacturing process that generate biological materials that stimulate a patient's own stem cells to activate and regenerate tissue is truly unique," said Ms. Daniels. "Histogen's focus on developing potential first-in-class restorative therapeutics is perfectly aligned with my industry experience and scientific passion."

    About Histogen

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen's proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss our future operations and our ability to successfully initiate and complete clinical trials, obtain clinical trial data and achieve regulatory milestones and related timing; the nature, strategy and focus of our business; the sufficiency of our cash resources and ability to achieve value for our stockholders; and the development and commercial potential and potential benefits of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of ours that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of our product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies of Histogen's product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase its costs and expenses; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; and the ability to attract and retain key personnel. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in our filings with the Securities and Exchange Commission. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.

    CONTACT:

    Susan A. Knudson

    Executive Vice President & CFO

    Histogen Inc.

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  3. SAN DIEGO, Oct. 05, 2020 (GLOBE NEWSWIRE) -- 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, today 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.

    "We are pleased to have 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," said Richard W. Pascoe, Histogen's President…

    SAN DIEGO, Oct. 05, 2020 (GLOBE NEWSWIRE) -- 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, today 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.

    "We are pleased to have 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," said Richard W. Pascoe, Histogen's President and CEO. "We believe HST-001 has the potential to stimulate new long-lasting hair growth in contrast to the two FDA approved therapies that focus on reducing hair loss."

    About the HST-001 Phase 1a/2b Trial

    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.

    About HST-001

    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.

    About Histogen

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen's proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss our future operations and our ability to successfully initiate and complete clinical trials, obtain clinical trial data and achieve regulatory milestones and related timing, including those related to the reporting of topline data for the ongoing HST-001 Phase 1a/2b clinical trial for the treatment of androgenic alopecia in men; the nature, strategy and focus of our business; the sufficiency of our cash resources and ability to achieve value for our stockholders; and the development and commercial potential and potential benefits of any of our product candidates, including HST-001. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of ours that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of our product candidates, including potential delays in the commencement, enrollment and completion of clinical trials, such as the reporting of the topline data for the ongoing HST-001 Phase 1a/2b clinical trial for the treatment of androgenic alopecia in men; the potential that earlier clinical trials and studies of Histogen's product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in our filings with the Securities and Exchange Commission. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.

    CONTACT:

    Susan A. Knudson

    Executive Vice President & CFO

    Histogen Inc.

     

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  4. HST-002 Designated as Drug-Biologic-Device Combination Product

    HST-001 1b/2a Trial for Androgenic Alopecia in Men on Track for Top Line Data Results in 4Q20

    HST-003 IND Submission for Regeneration of Cartilage in the Knee Expected 4Q20

    SAN DIEGO, Sept. 29, 2020 (GLOBE NEWSWIRE) -- 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, today 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…

    HST-002 Designated as Drug-Biologic-Device Combination Product

    HST-001 1b/2a Trial for Androgenic Alopecia in Men on Track for Top Line Data Results in 4Q20

    HST-003 IND Submission for Regeneration of Cartilage in the Knee Expected 4Q20

    SAN DIEGO, Sept. 29, 2020 (GLOBE NEWSWIRE) -- 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, today 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.    

    "Assuming the IDE had been granted by FDA, we planned to initiate a Phase 1 clinical trial designed to assess the safety and tolerability of HST-002, as well as look for early indications of efficacy versus Restylane-L in moderate to severe nasolabial folds, in the fourth quarter of 2020," said Richard W. Pascoe, Histogen's President and CEO. "Based upon FDA's communications that HST-002 will be regulated as a drug-biologic-device combination product, we are evaluating the impact to our clinical timeline and expect to provide an update in the fourth quarter of 2020."

    "We remain on track to announce top line data results in the fourth quarter of this year for our HST-001 phase 1b/2a trial for androgenic alopecia in men," said Richard W. Pascoe, Histogen's President and CEO. "HST-001, if approved, could be a first-in-class product given its potential to stimulate new long-lasting hair growth in contrast to existing therapies that focus on reducing hair loss.   In addition, we continue to make progress on our HST-003 program for regeneration of cartilage in the knee and anticipate filing an IND in the fourth quarter of 2020."

    About HST-002

    HST-002 is a human-derived collagen and extracellular matrix dermal filler intended to be injected into the dermis for the treatment of facial folds and wrinkles. Human Extracellular Matrix, or hECM is an insoluble hECM for applications such as orthopedics and soft tissue augmentation, which can be fabricated into a variety of structural or functional forms for tissue engineering and clinical applications. The hECM produced through Histogen's proprietary process is a novel, all-human, naturally secreted material. It is most similar to early embryonic structural tissue which provides the framework and signals necessary for cell in-growth and tissue development. By producing similar ECM materials to those that aided in the original formation of these tissues in the embryo, regenerative cells are supported in vitro and have shown potential as therapeutics in vivo.

    About Histogen

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen's proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss our future operations and our ability to successfully initiate and complete clinical trials, obtain clinical trial data, and achieve regulatory milestones and related timing, including those related to the submission of a HST-003 IND for regeneration of cartilage in the knee, any initiation of a HST-002 Phase 1 trial for the treatment of moderate to severe nasolabial folds and the reporting of topline data for the ongoing HST-001 Phase 1a/2b trial for androgenic alopecia in men; the nature, strategy and focus of our business; the sufficiency of our cash resources and ability to achieve value for our stockholders; and the development and commercial potential and potential benefits of any of our product candidates, such as HST-001, HST-002 and HST-003. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of ours that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of our product candidates, including potential delays in the commencement, enrollment and completion of clinical trials,; the potential that earlier clinical trials and studies of our product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in our filings with the Securities and Exchange Commission. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.

    CONTACT:

    Susan A. Knudson

    Executive Vice President & CFO

    Histogen Inc.

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  5. Investigational New Drug (IND) Filing Expected in the Fourth Quarter of 2020

    SAN DIEGO, Sept. 16, 2020 (GLOBE NEWSWIRE) -- 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, 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…

    Investigational New Drug (IND) Filing Expected in the Fourth Quarter of 2020

    SAN DIEGO, Sept. 16, 2020 (GLOBE NEWSWIRE) -- 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, 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.

    "The Steadman Clinic is world renowned for our dedication to excellence in treating orthopedic defects and we are excited about being a clinical center for studying Histogen's human extracellular matrix, or hECM, for focal lesions of the knee," said Matthew Provencher MD, CAPT, MC, USNR.  "Regenerating uniform functional hyaline cartilage is critical to restoring normal function for military personnel and civilians alike."

    "Lesions in articular knee cartilage can cause considerable morbidity and current surgical options may result in uneven repair and a scar-like fibrous cartilage instead of the normal hyaline cartilage that provides the greatest long-term function," said Dr. Gail K. Naughton, Histogen Founder and CSO. "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 our 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 yearii.

    "These non-dilutive funds will support our efforts to clinically evaluate the safety and efficacy of our novel cartilage repair treatment which has applicability in both the military and civilian populations," said Richard W. Pascoe, Histogen's President and CEO. "As a former soldier, I understand that the health and readiness of our servicemembers is essential to our national defense. We are pleased to partner with the DoD and these prestigious clinical sites to advance HST-003 into the clinic in support of that effort."

    The views expressed in this press release are those of the author and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.

    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.

    About Histogen

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen's proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Histogen's future operations and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones and related timing, including those related to the planned Phase 1/2 clinical trial of HST-003 for regeneration of cartilage in the knee; the nature, strategy and focus of Histogen's business; and the development and commercial potential and potential benefits of any of Histogen's product candidates. Histogen may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on Histogen's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of Histogen's product candidates, including potential delays in the commencement, enrollment and completion of clinical trials such as the planned Phase 1/2 clinical trial of HST-003 for regeneration of cartilage in the knee; the potential that earlier clinical trials and studies of Histogen's product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen's financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in Histogen's filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.

    i Merkely, G., Ackermann, J. & Lattermann, C. Articular Cartilage Defects: Incidence, Diagnosis, and Natural History. Oper. Tech. Sports Med. 26, 156–161 (2018).

    ii Teyhen, D. S., Goffar, S. L., Shaffer, S. W., Kiesel, K., Butler, R. J., Tedaldi, A.-M., Prye, J. C., Rhon, D. I. & Plisky, P. J. Incidence of Musculoskeletal Injury in US Army Unit Types: A Prospective Cohort Study. J. Orthop. Sports Phys. Ther. 48, 749–757 (2018).

    CONTACT:

    Susan A. Knudson

    Executive Vice President & CFO

    Histogen, Inc.

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  6. SAN DIEGO, Sept. 10, 2020 (GLOBE NEWSWIRE) -- 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, today announced completion of patient dosing for the week 6 treatment timepoint 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.

    "We are pleased to have accomplished the second of three treatment timepoints in our HST-001 trial and we remain on track to announce top line data results in the fourth quarter of this year," said Richard W. Pascoe…

    SAN DIEGO, Sept. 10, 2020 (GLOBE NEWSWIRE) -- 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, today announced completion of patient dosing for the week 6 treatment timepoint 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.

    "We are pleased to have accomplished the second of three treatment timepoints in our HST-001 trial and we remain on track to announce top line data results in the fourth quarter of this year," said Richard W. Pascoe, Histogen's President and CEO.  "HST-001, if approved, could be a first-in-class product given its potential to stimulate new long-lasting hair growth in contrast to existing therapies that focus on reducing hair loss."

    About the HST-001 Phase 1a/2b Trial

    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 temporal recession region and 5 in each vertex scalp 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.

    About HST-001

    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.

    About Histogen

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen's proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.  For more information, please visit www.histogen.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Histogen's future operations and its ability to successfully initiate and complete clinical trials, obtain clinical trial data and achieve regulatory milestones and related timing, including those related to the reporting of topline data for the ongoing HST-001 Phase 1a/2b clinical trial for the treatment of androgenic alopecia in men; the nature, strategy and focus of Histogen's business; and the development and commercial potential and potential benefits of any of Histogen's product candidates, including HST-001. Histogen may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on Histogen's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of Histogen's product candidates, including potential delays in the commencement, enrollment and completion of clinical trials, such as the reporting of the topline data for the ongoing HST-001 Phase 1a/2b clinical trial for the treatment of androgenic alopecia in men; the potential that earlier clinical trials and studies of Histogen's product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen's financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in Histogen's filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.

    CONTACT:

    Susan A. Knudson

    Executive Vice President & CFO

    Histogen Inc.

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  7. SAN DIEGO, Sept. 01, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Richard W. Pascoe, President and Chief Executive Officer of Histogen, will present at the HC Wainwright 22nd Annual Global Investment Conference.  The virtual presentation is scheduled for Tuesday, September 15, 2020 at 11:30 a.m. Eastern Time.

    Presentation Details

    Date: Tuesday September 15, 2020
    Time: 11:30 a.m. Eastern Time (8:30 a.m. Pacific Time)
    Live Webcast Link: https://wsw.com/webcast/hcw7/hsto/1625710

    For those not available to listen to…

    SAN DIEGO, Sept. 01, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Richard W. Pascoe, President and Chief Executive Officer of Histogen, will present at the HC Wainwright 22nd Annual Global Investment Conference.  The virtual presentation is scheduled for Tuesday, September 15, 2020 at 11:30 a.m. Eastern Time.

    Presentation Details



    Date: Tuesday September 15, 2020

    Time: 11:30 a.m. Eastern Time (8:30 a.m. Pacific Time)

    Live Webcast Link: https://wsw.com/webcast/hcw7/hsto/1625710

    For those not available to listen to the live broadcast, a replay will be archived for 90 days and available through the Investors page on www.histogen.com.

    About Histogen Inc.

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen's proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

    CONTACT:

    Susan A. Knudson

    Executive Vice President & CFO

    Histogen Inc.

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  8. Completed Enrollment for HST-001 Phase 1a/2b Trial for Androgenic Alopecia in Men with Topline Data Expected 4Q20
    Filed IDE for HST-002 for Treatment of Moderate to Severe Nasolabial Folds
    Appointed Susan A. Knudson as Chief Financial Officer

    SAN DIEGO, Aug. 13, 2020 (GLOBE NEWSWIRE) -- 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, today reported financial results for the second quarter ended June 30, 2020 and provided an update on its clinical pipeline and other corporate developments.

    Key Second Quarter 2020 Highlights and Subsequent Updates

    • Filed Investigational

    Completed Enrollment for HST-001 Phase 1a/2b Trial for Androgenic Alopecia in Men with Topline Data Expected 4Q20

    Filed IDE for HST-002 for Treatment of Moderate to Severe Nasolabial Folds

    Appointed Susan A. Knudson as Chief Financial Officer

    SAN DIEGO, Aug. 13, 2020 (GLOBE NEWSWIRE) -- 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, today reported financial results for the second quarter ended June 30, 2020 and provided an update on its clinical pipeline and other corporate developments.

    Key Second Quarter 2020 Highlights and Subsequent Updates

    • Filed Investigational Device Exemption (IDE) for HST-002. In April, Histogen filed an IDE application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of HST-002 as a dermal filler for the treatment of moderate to severe nasolabial folds. If the application is approved, Histogen plans to initiate the clinical trial in fourth quarter of 2020.

       
    • Closed Reverse Merger with Conatus.  In May, Histogen closed the reverse merger transaction with Conatus.  The transaction included approximately $13.0 million in cash resources, which when combined with existing resources, is expected to fund Histogen's current operating plan into the second quarter of 2021. The combined company changed its name from Conatus Pharmaceuticals Inc. to Histogen Inc. and began trading on the Nasdaq Capital Market under the ticker symbol "HSTO" on May 27, 2020.
    • Appointed Susan A. Knudson as Chief Financial Officer.  In May, Ms. Knudson joined Histogen as its Executive Vice President and Chief Financial Officer.  With over 20 years of experience in the biopharmaceutical industry, she brings a wealth of financial and corporate strategy expertise to Histogen.  Ms. Knudson most recently served as Chief Financial Officer at Pfenex Inc. and prior to Pfenex, she held the position of Chief Financial Officer of Neothetics, Inc. 



    • Completed Enrollment for HST-001 Phase 1a/2b trial for Androgenic Alopecia in Men with Topline Data Expected in the fourth quarter 2020.  Histogen announced that it initiated the trial in June, completed enrollment in July and expects to report topline results in the fourth quarter of 2020.

       
    • Entered into Common Stock Purchase Agreement for Up to $10 Million.  In July, Histogen entered into a common stock purchase agreement for up to $10 million with Lincoln Park Capital Fund, LLC.  Upon execution of the purchase agreement, Lincoln Park made an initial purchase of $1.0 million of common stock.      

    "Throughout the second quarter of this year, we focused on transforming Histogen into a leading restorative therapeutics development company through the completion of the reverse merger, obtaining a NASDAQ listing, strengthening the executive team and advancing our innovative therapeutics pipeline," said Richard W. Pascoe, Histogen's President and Chief Executive Officer.  "In the remaining months of 2020, we will focus on achieving a number of near-term clinical and regulatory value-inflection points, such as filing an IND for our HST-003 program focused on knee cartilage repair, initiating a Phase 1 trial for HST-002 for the treatment of moderate to severe nasolabial folds and reporting topline results from our HST-001 Phase 1a/2b trial for androgenic alopecia in men. Moreover, I want to take this opportunity to commend the entire Histogen team for their tireless efforts, in the midst of a global pandemic, to position the company for success in 2020 and beyond."

    Expected Second Half 2020 Milestones

    • Submit HST-003 IND for the regeneration of cartilage in the knee
    • Initiate HST-002 Phase 1 trial for the treatment of moderate to severe nasolabial folds, if IDE is approved
    • Report topline data for HST-001 Phase 1a/2b trial for androgenic alopecia in men

    Financial Highlights for the Second Quarter 2020

    Revenues for the three months ended June 30, 2020 and 2019 were $0.1 million and $1.4 million, respectively. The year-over-year decrease of $1.3 million was primarily due to a decrease in the fulfillment of supply orders of CCM to Allergan and one additional customer.

    Cost of revenues for the three months ended June 30, 2020 and 2019, were $0 million and $0.5 million, respectively. The decrease of $0.5 million for the three months ended June 30, 2020 as compared to the three months ended June 30, 2019 was due to a decrease in fulfillment of supply orders of CCM to Allergan and one additional customer.

    For both the three months ended June 30, 2020 and 2019, we recognized costs of professional services of $0.1 million related to our Allergan License Agreements.

    In-process research and development expenses for the three months ended June 30, 2020 and 2019 were $7.1 million and $2.3 million, respectively.  In the three months ended June 30, 2020, we incurred $7.1 million for in-process research and development acquired in connection with the reverse merger with Conatus and in the three months ended June 30, 2019, we incurred $2.3 million for in-process research and development related to the acquisition of HST-003 and HST-004  from PUR Biologics LLC.

    Research and development expenses for the three months ended June 30, 2020 and 2019 were $1.4 million and $1.0 million, respectively. The increase of $0.4 million for the three months ended June 30, 2020 was primarily due to an increase in development costs for our  product candidates.

    General and administrative expenses for both the three months ended June 30, 2020 and 2019 were $1.6 million. The three months ended June 30, 2019 included success-based fees of approximately $0.8 million related to $7.5 million of license revenue received in the three months ended June 30, 2019 for which there was no comparable expense incurred in the three months ended June 30, 2020.  This decrease for the three months ended June 30, 2020 was offset by increases in personnel related expenses,  legal and accounting fees in the three months ended June 30, 2020.

    Cash and cash equivalents as of June 30, 2020 were $10.4 million.  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.

    About Histogen Inc.

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen's proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Histogen's future operations and its ability to successfully initiate and complete clinical trials, obtain clinical trial data, and achieve regulatory milestones and related timing, including those related to the submission of a HST-003 IND for regeneration of cartilage in the knee, the initiation of a HST-002 Phase 1 trial for the treatment of moderate to severe nasolabial folds and the reporting of topline data for the ongoing HST-001 Phase 1a/2b trial for androgenic alopecia in men; the nature, strategy and focus of Histogen's business; the sufficiency of Histogen's cash resources and Histogen's ability to achieve value for its stockholders; and the development and commercial potential and potential benefits of any of Histogen's product candidates, such as HST-001, HST-002 and HST-003. Histogen may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on Histogen's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of Histogen's product candidates, including potential delays in the commencement, enrollment and completion of clinical trials, such as the planned HST-002 Phase 1 trial for the treatment of moderate to severe nasolabial folds and the reporting of topline data for the ongoing HST-001 Phase 1a/2b trial for androgenic alopecia in men; the potential that earlier clinical trials and studies of Histogen's product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen's financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in Histogen's filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.

    CONTACT:

    Susan A. Knudson

    Executive Vice President & CFO

    Histogen Inc.



    HISTOGEN INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except share and per share amounts)

      June 30,

    2020
      December 31,

    2019
     
      (unaudited)     
    Assets        
    Current assets:        
    Cash and cash equivalents $10,394  $2,065 
    Restricted cash  10   10 
    Accounts receivable, net  136   110 
    Inventories  431   106 
    Prepaid and other current assets  693   167 
    Total current assets  11,664   2,458 
    Restricted cash  250    
    Property and equipment, net  318   320 
    Right-of-use assets  4,468   95 
    Other assets  1,073   69 
    Total assets $17,773  $2,942 
    Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)        
    Current liabilities:        
    Accounts payable $2,659  $808 
    Accrued liabilities  950   446 
    Current portion of lease liabilities  116   108 
    Current portion of deferred revenue  157   19 
    Total current liabilities  3,882   1,381 
    Paycheck Protection Program loan  467    
    Noncurrent portion of lease liabilities  4,666    
    Noncurrent portion of deferred revenue  128   138 
    Other liabilities  317   321 
    Total liabilities  9,460   1,840 
    Commitments and contingencies (Note 10)        
    Convertible preferred stock, $0.001 par value; no shares and 73,000,000 shares authorized at June 30, 2020 and December 31, 2019, respectively; no shares and 5,046,154 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively; liquidation preference of $0 and $40,294 at June 30, 2020 and December 31, 2019, respectively     39,070 
    Stockholders' Equity (Deficit)        
    Preferred stock, $0.0001 par value; 10,000,000 shares and no shares authorized at June 30, 2020 and December 31, 2019, respectively; no shares issued and outstanding at June 30, 2020 and December 31, 2019      
    Common stock, $0.0001 par value; 200,000,000 shares and 105,000,000 shares authorized at June 30, 2020 and December 31, 2019, respectively; 11,812,493 shares and 3,343,356 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively  1    
    Additional paid-in capital  65,176   6,864 
    Accumulated deficit  (55,945)  (43,933)
    Total Histogen Inc. stockholders' equity (deficit)  9,232   (37,069)
    Noncontrolling interest  (919)  (899)
    Total equity (deficit)  8,313   (37,968)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $17,773  $2,942 
     
     

    HISTOGEN INC. AND SUBSIDIARIES

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except share and per share amounts)

      Three Months Ended June 30,  Six Months Ended June 30, 
      2020  2019  2020  2019 
    Revenues:                
    License $5  $5  $872  $7,510 
    Product     1,184      1,766 
    Grant     150      150 
    Professional services  103   86   214   153 
    Total revenues  108   1,425   1,086   9,579 
    Operating expenses:                
    Cost of product revenue     513   161   792 
    Cost of professional services revenue  89   75   186   133 
    Acquired in-process research and development  7,144   2,250   7,144   2,250 
    Research and development  1,437   985   2,828   2,043 
    General and administrative  1,588   1,551   2,771   3,405 
    Total operating expenses  10,258   5,374   13,090   8,623 
    Income (loss) from operations  (10,150)  (3,949)  (12,004)  956 
    Other income (expense):                
    Change in fair value of warrant liabilities     25      47 
    Interest income (expense), net  (28)  17   (28)  18 
    Net income (loss)  (10,178)  (3,907)  (12,032)  1,021 
                     
    Net loss attributable to noncontrolling interest  10   8   20   17 
    Net income attributable to preferred stockholders           (624)
    Net income (loss) attributable to common stockholders $(10,168) $(3,899) $(12,012) $414 
    Net income (loss) per share attributable to common stockholders:                
    Basic $(1.52) $(1.17) $(2.39) $0.12 
    Diluted $(1.52) $(1.17) $(2.39) $0.11 
    Weighted-average common shares used to compute net income (loss) per share attributable to common stockholders:                
    Basic  6,710,490   3,327,376   5,026,923   3,321,023 
    Diluted  6,710,490   3,327,376   5,026,923   3,833,835 

     

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  9. SAN DIEGO, July 30, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Histogen's financial results for the second quarter ended June 30, 2020 will be released after the close of market on Thursday, August 13, 2020.

    About Histogen Inc.

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned…

    SAN DIEGO, July 30, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Histogen's financial results for the second quarter ended June 30, 2020 will be released after the close of market on Thursday, August 13, 2020.

    About Histogen Inc.

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen's proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

    CONTACT:

    Susan A. Knudson

    Executive Vice President & CFO

    Histogen Inc.

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  10. SAN DIEGO, July 29, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Richard W. Pascoe, President and Chief Executive Officer of Histogen, will present at the Canaccord Genuity 40th Annual Growth Conference.  The virtual presentation is scheduled for Wednesday, August 12, 2020 at 1:30 p.m. Eastern Time.

    Presentation Details

    Date: Wednesday August 12, 2020
    Time: 1:30 p.m. Eastern Time (10:30 a.m. Pacific Time)
    Live Webcast Link: https://wsw.com/webcast/canaccord42/hsto

    For those not available to listen to the live broadcast…

    SAN DIEGO, July 29, 2020 (GLOBE NEWSWIRE) -- 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, today announced that Richard W. Pascoe, President and Chief Executive Officer of Histogen, will present at the Canaccord Genuity 40th Annual Growth Conference.  The virtual presentation is scheduled for Wednesday, August 12, 2020 at 1:30 p.m. Eastern Time.

    Presentation Details



    Date: Wednesday August 12, 2020

    Time: 1:30 p.m. Eastern Time (10:30 a.m. Pacific Time)

    Live Webcast Link: https://wsw.com/webcast/canaccord42/hsto

    For those not available to listen to the live broadcast, a replay will be archived for 90 days and available through the Investors page on www.histogen.com.

    About Histogen Inc.

    Histogen Inc. is 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. Histogen's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen's proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

    CONTACT:

    Susan A. Knudson

    Executive Vice President & CFO

    Histogen Inc.

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  11. SAN DIEGO, July 20, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. ("Histogen" or the "Company") (NASDAQ:HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, today announced that it has that it has entered into a common stock purchase agreement for up to $10 million with Lincoln Park Capital Fund, LLC ("Lincoln Park"), a Chicago-based institutional investor. Upon execution of the purchase agreement, Lincoln Park made an initial purchase of $1.0 million of common stock.

    Under the terms of the purchase agreement, the Company will have the right, in its sole discretion, to sell shares of its common stock to Lincoln Park over the 24-month term of the purchase agreement. Any common…

    SAN DIEGO, July 20, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. ("Histogen" or the "Company") (NASDAQ:HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, today announced that it has that it has entered into a common stock purchase agreement for up to $10 million with Lincoln Park Capital Fund, LLC ("Lincoln Park"), a Chicago-based institutional investor. Upon execution of the purchase agreement, Lincoln Park made an initial purchase of $1.0 million of common stock.

    Under the terms of the purchase agreement, the Company will have the right, in its sole discretion, to sell shares of its common stock to Lincoln Park over the 24-month term of the purchase agreement. Any common stock sold to Lincoln Park will occur at a purchase price that is based on the prevailing prices of the common stock at the time of each sale. The Company will control the timing and amount of any shares of common stock sold to Lincoln Park, and Lincoln Park is obligated to make purchases at quantities and prices in accordance with the purchase agreement. Histogen's sale of common stock is subject to various limitations including those set forth in the purchase agreement and the listing rules of Nasdaq.

    The Company intends to use any proceeds it receives under the purchase agreement for working capital and general corporate purposes. There are no warrants, limitations on use of proceeds, financial or business covenants, rights of first refusal, participation rights, penalties or liquidated damages in the purchase agreement.

    As part of the agreement, Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company's common stock. In consideration for Lincoln Park entering into the purchase agreement, Histogen issued shares of its common stock to Lincoln Park as a commitment fee. The purchase agreement may be terminated by the Company at any time, at its sole discretion, without any cost or penalty.

    Additional information regarding the purchase agreement is set forth in a Current Report on Form 8-K, which Histogen filed today with the SEC.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities in the described offering, nor shall there be any offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

    About Histogen

    Histogen is a regenerative medicine company developing patented technologies that replace and regenerates tissues in the body. The company's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells, developing therapeutic products that address underserved, multi-billion US dollar global markets. For more information, please visit www.histogen.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This communication contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "1933 Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "1934 Act"). Any statements contained herein that are not of historical facts may be deemed to be forward-looking statements. In some cases, you can identify these statements by words such as such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "should," "could," "estimates," "predicts," "potential," "continue," "guidance," and other similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements include, but are not limited to, statements regarding Histogen's common stock purchase agreement transaction with Lincoln Park, including proposed use of proceeds. These forward-looking statements are based on current expectations, estimates, forecasts, and projections about our business and the industry in which we operate and management's beliefs and assumptions and are not guarantees of future performance or developments and involve known and unknown risks, uncertainties, and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this communication may turn out to be inaccurate. Factors that could materially affect our business operations and financial performance and condition include, but are not limited to, those risks and uncertainties described under Part I Item 1A—"Risk Factors" in our most recent Annual Report on Form 10-K, Part II Item 1A—"Risk Factors" in our Form 10-Q for the quarter ended March 31, 2020, the "Risk Factors" described in our prospectus dated April 1, 2020, filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act, relating to the Registration Statement on Form S-4, as amended (File No. 333-236332), and in other documents we may file with the SEC. You are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are based on information available to us as of the date of this communication. Unless required by law, we do not intend to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise.

    Contact:

    Susan Knudson

    Executive Vice President & CFO

    Histogen, Inc.

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  12. SAN DIEGO, July 14, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ:HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, today announced completion of patient enrollment ahead of schedule 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.

     "We are pleased to have accomplished this clinical milestone with HST 001 and we look forward to completing the treatment phase of the study and releasing top-line data in the fourth quarter of this year," said Richard W. Pascoe, Histogen's President and CEO.  "The on-time achievement of this milestone demonstrates…

    SAN DIEGO, July 14, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ:HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, today announced completion of patient enrollment ahead of schedule 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.

     "We are pleased to have accomplished this clinical milestone with HST 001 and we look forward to completing the treatment phase of the study and releasing top-line data in the fourth quarter of this year," said Richard W. Pascoe, Histogen's President and CEO.  "The on-time achievement of this milestone demonstrates our ability to execute on the clinical development plans for HST 001, which has the potential to stimulate new long-lasting hair growth in contrast to existing therapies that focus on reducing hair loss."

    About the HST 001 Phase 1a/2b Trial

    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 divided between the temporal recession and vertex scalp areas, the most common regions of hair loss in men with androgenic alopecia.  Primary endpoints will be assessed at Week 18 and secondary endpoints at both Week 18 and Week 26.  Top-line data is anticipated to be available in the fourth quarter of 2020.

    About HST 001

    HST 001, or Hair Stimulating Complex (HSC), is intended to be a physician-administered therapeutic for hair loss. We expect HSC to be a relatively safe, minimally invasive treatment that promotes new hair growth where existing treatments only reduce hair loss. HSC is designed 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.

    About Histogen

    Histogen is a regenerative medicine company developing patented technologies that replace and regenerates tissues in the body. The company's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells, developing therapeutic products that address underserved, multi-billion US dollar global markets.  For more information, please visit www.histogen.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Histogen's future operations and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones and related timing, including those related to the planned Phase 1a/2b clinical trial of HST 001 for the treatment of androgenic alopecia in men; the nature, strategy and focus of Histogen's business; and the development and commercial potential and potential benefits of any of Histogen's product candidates, including HST 001. Histogen may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on Histogen's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of Histogen's product candidates, including potential delays in the commencement, enrollment and completion of clinical trials, such as the completion of the Phase 1a/2b clinical trial of HST 001 for the treatment of androgenic alopecia in men; the potential that earlier clinical trials and studies of Histogen's product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen's financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in Histogen's filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.

    CONTACT:



    Susan A. Knudson

    Executive Vice President & CFO

    Histogen Inc.

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  13. SAN DIEGO, June 03, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ:HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, announced today that it will be featured as a presenting company at BIO Digital 2020, being held virtually June 8-12, 2020.

    In addition to completion of its merger with Conatus Pharmaceuticals in May 2020, enrollment is currently underway in Histogen's Phase 1b/2a clinical trial of its lead product candidate, HST 001, for male pattern hair loss. Histogen also anticipates clinical advancement of HST 002, a novel dermal filler product, and HST 003, a product targeting joint cartilage regeneration, this year.

    Richard W. Pascoe, President and CEO of Histogen…

    SAN DIEGO, June 03, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ:HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, announced today that it will be featured as a presenting company at BIO Digital 2020, being held virtually June 8-12, 2020.

    In addition to completion of its merger with Conatus Pharmaceuticals in May 2020, enrollment is currently underway in Histogen's Phase 1b/2a clinical trial of its lead product candidate, HST 001, for male pattern hair loss. Histogen also anticipates clinical advancement of HST 002, a novel dermal filler product, and HST 003, a product targeting joint cartilage regeneration, this year.

    Richard W. Pascoe, President and CEO of Histogen, will provide an overview of the Company's technology and development pipeline during the BIO Digital event. Details of the presentation are as follows:

    Date:  June 8-12, 2020
    Location:  https://www.bio.org/events/bio-digital

    Presentation recordings will remain available on-demand through the event website for 30 days. Histogen's presentation will also be available for download through the Company's website at https://investors.histogen.com/events-and-presentations beginning June 8, 2020.

    About Histogen
    Histogen is a regenerative medicine company developing patented technologies that replace and regenerates tissues in the body. The company's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells, developing therapeutic products that address underserved, multi-billion US dollar global markets. For more information, please visit www.histogen.com.

    Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Histogen's future operations and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones and related timing; the nature, strategy and focus of Histogen's business; and the development and commercial potential and potential benefits of any of Histogen's product candidates. Histogen may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on Histogen's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of Histogen's product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies of Histogen's product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen's financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in Histogen's filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

    CONTACT:

    Susan Knudson
    Executive Vice President & CFO
    Histogen, Inc.

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  14. SAN DIEGO, June 01, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ:HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, announced today the enrollment of the first patient in its Phase 1b/2a clinical trial of HST 001, the Company's lead therapeutic candidate for the treatment of androgenic alopecia in men.

    This blinded, randomized, placebo controlled, single site study will enroll 36 subjects with male pattern hair loss using a 2:1 randomization 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…

    SAN DIEGO, June 01, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ:HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, announced today the enrollment of the first patient in its Phase 1b/2a clinical trial of HST 001, the Company's lead therapeutic candidate for the treatment of androgenic alopecia in men.

    This blinded, randomized, placebo controlled, single site study will enroll 36 subjects with male pattern hair loss using a 2:1 randomization 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.

    "The initiation of this clinical trial is a critical milestone for Histogen following the completion of our merger and listing on the Nasdaq Capital Market last week," said Richard Pascoe, Chief Executive Officer of Histogen. "HST 001 is a potentially transformative approach to treating androgenic alopecia given that existing therapies focus on reducing hair loss, while HST 001 has the potential to stimulate new long-lasting hair growth."

    Building on prior clinical experience with HST 001, the Phase 1b/2a study will be the first company-sponsored trial to include a third dosing timepoint, with dosing taking place at week 0, week 6 and week 12. At each treatment timepoint, subjects will receive 20 injections focused on temporal recession and vertex scalp areas, the most common regions of hair loss in men with androgenic alopecia. Top-line data is anticipated to be available in the fourth quarter of 2020.

    About HST 001
    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.

    About Histogen
    Histogen is a regenerative medicine company developing patented technologies that replace and regenerates tissues in the body. The company's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells, developing therapeutic products that address underserved, multi-billion US dollar global markets. For more information, please visit www.histogen.com.

    Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Histogen's future operations and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones and related timing; the nature, strategy and focus of Histogen's business; and the development and commercial potential and potential benefits of any of Histogen's product candidates. Histogen may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on Histogen's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of Histogen's product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies of Histogen's product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen's financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in Histogen's filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

    CONTACT: Eileen Brandt
    Histogen Inc.
    (858) 526-3106

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  15. SAN DIEGO, May 28, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ:HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, announced today the appointment of Susan A. Knudson as Executive Vice President and Chief Financial Officer.

    "We are proud to welcome Susan to serve as our Executive Vice President and Chief Financial Officer during this important time as we transition into a public company," said Richard W. Pascoe, President and Chief Executive Officer of Histogen. "With over 20 years of experience in the biopharmaceutical industry, Susan brings a wealth of financial and corporate strategy expertise to Histogen as we evolve into a leading regenerative medicine focused company…

    SAN DIEGO, May 28, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ:HSTO), a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, announced today the appointment of Susan A. Knudson as Executive Vice President and Chief Financial Officer.

    "We are proud to welcome Susan to serve as our Executive Vice President and Chief Financial Officer during this important time as we transition into a public company," said Richard W. Pascoe, President and Chief Executive Officer of Histogen. "With over 20 years of experience in the biopharmaceutical industry, Susan brings a wealth of financial and corporate strategy expertise to Histogen as we evolve into a leading regenerative medicine focused company."

    Prior to coming to Histogen, Ms. Knudson most recently served as Senior Vice President and Chief Financial Officer of Pfenex Inc, where she successfully led fund raising efforts and executed on strategies to grow the business from development stage through commercialization.

    Prior to Pfenex, Ms. Knudson held the position of Chief Financial Officer of Neothetics, Inc., an aesthetics focused pharmaceutical company, where she led the company's strategic and corporate finance activities from pre-IPO through IPO. Among her previous roles, she served as Senior Director of Finance and Administration at Avera Pharmaceuticals, where she drove financing strategy, and was an integral part of the business development team interacting with multinational pharmaceutical companies.

    "I am excited to join Histogen at this pivotal time, and I'm confident that my diverse background in healthcare will meaningfully complement the team as we move to execute on the Histogen pipeline of product candidates and overall corporate strategy," said Ms. Knudson.

    About Histogen
    Histogen is a regenerative medicine company developing patented technologies that replace and regenerates tissues in the body. The company's innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells, developing therapeutic products that address underserved, multi-billion US dollar global markets. For more information, please visit www.histogen.com.

    Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Histogen's future operations and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones and related timing; the nature, strategy and focus of Histogen's business; and the development and commercial potential and potential benefits of any of Histogen's product candidates. Histogen may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on Histogen's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of Histogen's product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies of Histogen's product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen's financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the those risks discussed in Histogen's filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

    CONTACT: Eileen Brandt
    Histogen Inc.
    (858) 526-3106

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