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Find Clinical Drug Pipeline Developments & Deals by Histogen

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            Lead Product(s): Emricasan

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Small molecule

            Recipient: Amerimmune

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration October 27, 2020

            Details:

            Histogen will retain ownership and oversight over emricasan and responsibility for all regulatory filings and maintaining its existing caspase inhibitor patent portfolio. Amerimmune will lead development efforts of emricasan in a phase 1 study in mild-COVID-19 patients.

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            Lead Product(s): HST-001

            Therapeutic Area: Dermatology Product Name: HST-001

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 05, 2020

            Details:

            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.

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            Lead Product(s): HST-002

            Therapeutic Area: Dermatology Product Name: HST-002

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 29, 2020

            Details:

            Histogen received communications from the Office of Combination Products that HST-002 is a drug-biologic-device combination product. HST-001 1b/2a trial for androgenic alopecia in men on track for top line data results in 4Q20.

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            Lead Product(s): HST-003

            Therapeutic Area: Musculoskeletal Product Name: HST-003

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: U.S. Department of Defense

            Deal Size: $2.0 million Upfront Cash: Undisclosed

            Deal Type: Funding September 16, 2020

            Details:

            The funding supports Phase 1/2 clinical trial of HST-003 for regeneration of cartilage in the knee led by Histogen. The trial is designed to evaluate HST-003 in combination with a microfracture procedure to treat recent focal cartilage defects in the knee caused by injury.

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            Lead Product(s): HST 001

            Therapeutic Area: Dermatology Product Name: Undisclosed

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2020

            Details:

            This blinded, randomized, placebo controlled, single site study is designed to assess the safety and tolerability of HST 001, and indicators of efficacy including non-vellus hair count, total hair count, and hair thickness density as measured by Canfield macrophotography.

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            Lead Product(s): HST 001

            Therapeutic Area: Dermatology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Recipient: Conatus Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Merger May 27, 2020

            Details:

            This merger is transformative for Histogen as it looks to advance its novel regenerative medicine pipeline. The merger provides an opportunity for Histogen to become a leader in the aesthetics and orthopedic medicine markets.

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            Lead Product(s): HST 004

            Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 14, 2020

            Details:

            Clinical data from the first three cohorts of the ongoing Phase I dose-escalation trial demonstrating safety of MCY-M11 and feasibility of one-day manufacturing will be shared at the ASCO 2020.

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            Lead Product(s): HST 001

            Therapeutic Area: Dermatology Product Name: Undisclosed

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 11, 2020

            Details:

            Under this IND, Histogen intends to initiate a Phase 1b/2a clinical trial of HST 001, a Hair Stimulating Complex (HSC), in the second quarter of 2020.

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            Lead Product(s): HST 001

            Therapeutic Area: Dermatology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 06, 2020

            Details:

            Histogen has submitted IND amendment with the U.S. FDA for the initiation of a Phase 1b/2a clinical trial of its lead program, HST 001 for the treatment of androgenic alopecia in men.

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            Lead Product(s): HST 001

            Therapeutic Area: Dermatology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Conatus Pharmaceuticals

            Deal Size: $135.1 million Upfront Cash: Undisclosed

            Deal Type: Merger January 28, 2020

            Details:

            Proposed merger creates regenerative medicine company with three clinical-stage product candidates and combined company capitalization expected to support operations into 2021.