Humacyte(HUMA)

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Humacyte(HUMA) - 2023 Q4 - Annual Report
2024-03-28 12:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ___________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-39532 Humacyte, Inc. (Exact name of registrant as specified in its charter) ___ ...
Humacyte(HUMA) - 2023 Q4 - Annual Results
2024-03-22 11:06
Exhibit 99.1 -Raised approximately $43.1 million in net proceeds from public offering of common stock- -Conference call and live webcast at 8:00 a.m. ET today- DURHAM, N.C., March 22, 2024 – Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2023 and highlighted recent corporate accomplishments in advancing the in ...
Humacyte(HUMA) - 2023 Q3 - Earnings Call Transcript
2023-11-10 05:21
Financial Data and Key Metrics Changes - Research and development expenses increased to $18.6 million for Q3 2023 from $17.3 million in Q3 2022, and for the nine months ended September 30, 2023, expenses rose to $56.4 million from $48.3 million in the same period of 2022 [13] - Net loss for Q3 2023 was $26.0 million compared to $25.3 million in Q3 2022, and for the nine months ended September 30, 2023, net loss was $85.7 million compared to $8.2 million in the same period of 2022 [14][49] - No revenue was reported for Q3 2023, down from $31,000 in Q3 2022, and for the nine months ended September 30, 2023, revenue was $1.6 million compared to $1.6 million in the same period of 2022 [28] Business Line Data and Key Metrics Changes - The Human Acellular Vessel (HAV) demonstrated a 30-day patency rate of 90% in the V005 trial, compared to approximately 81% historically for synthetic grafts [22] - The HAV showed a lower amputation rate of 9.8% compared to over 20% for synthetic grafts, and an infection rate of 2% compared to over 8% historically for synthetic grafts [6][7] Market Data and Key Metrics Changes - Approximately 70,000 vascular injuries occur annually in the U.S. requiring repair, with tens of thousands needing grafting or surgical repair [35] - The company anticipates capturing a significant portion of the synthetic graft market and potentially some vein use in traumatic injury indications [36] Company Strategy and Development Direction - The company plans to submit a Biologics Licensing Application (BLA) for the HAV in vascular trauma during the current quarter, leveraging its Regenerative Medicine Advanced Therapy (RMAT) designation for priority review [24] - The company is focusing on health economics and budget impact modeling to support the HAV's utility in trauma care, aiming to improve patient outcomes and reduce hospital expenditures [41][63] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming BLA submission and the potential for priority review due to existing designations from the FDA and the Department of Defense [24][58] - The company highlighted the positive outcomes from humanitarian efforts in Ukraine, which will be included in the BLA filing [25] Other Important Information - As of September 30, 2023, the company had cash and cash equivalents of $100 million, with a funding arrangement of up to $160 million from Oberland Capital [47] - General and administrative expenses were $6.1 million for Q3 2023, slightly down from $6.2 million in Q3 2022, with a total of $17.5 million for the nine months ended September 30, 2023, compared to $17.1 million in the same period of 2022 [48] Q&A Session Summary Question: What additional data on V005 should be expected at VEITH? - The company will share efficacy results and safety outcomes during a podium presentation at the VEITH meeting [34] Question: Can you size up the market and low-hanging fruit post-approval? - The market size includes approximately 70,000 vascular injuries annually, with a significant portion requiring grafting [35] Question: What steps remain for the BLA submission process? - The BLA is complex, but much of it is ready, with two modules largely completed [40] Question: Will there be humanitarian efforts during the Gaza conflict? - The company has not received requests from surgeons in Israel but would consider them if they arise [61] Question: How open are surgeons to trying new procedures and options? - Trauma surgeons are generally more inclined to use biologics like HAV due to the ease of use compared to harvesting veins [68] Question: What are the plans for collecting real-world evidence post-launch? - The company plans to work with key opinion leaders and capture data on HAV usage in various trauma scenarios [83]
Humacyte(HUMA) - 2023 Q3 - Quarterly Report
2023-11-09 21:28
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________________________________________________________________________ FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to __ ...
Humacyte(HUMA) - 2023 Q2 - Earnings Call Transcript
2023-08-14 16:42
Humacyte Inc. (NASDAQ:HUMA) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET Company Participants Dr. Laura Niklason - President & CEO Dale Sander - CFO & Chief Corporate Development Officer Dr. Heather Prichard - COO Laura Marek - LifeSci Advisors, IR Conference Call Participants Ryan Zimmerman - BTIG Josh Jennings - TD Cowen Matthew O'Brien - Piper Sandler Suraj Kalia - Oppenheimer & Company Bruce Jackson - The Benchmark Company. Operator Good morning, ladies and gentlemen, and welcome to the H ...
Humacyte(HUMA) - 2023 Q2 - Quarterly Report
2023-08-14 12:44
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________________________________________________________________________ FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (State or other jurisdiction of incorporation or ...
Humacyte(HUMA) - 2023 Q1 - Quarterly Report
2023-05-12 20:18
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________________________________________________________________________ FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ ...
Humacyte(HUMA) - 2023 Q1 - Earnings Call Transcript
2023-05-12 15:27
Humacyte Inc. (NASDAQ:HUMA) Q1 2023 Results Conference Call May 12, 2023 8:00 AM ET Company Participants Lauren Marek - LifeSci Advisors Laura Niklason - Founder, President, CEO and Director Dale Sander - CFO, Chief Corporate Development Officer and Treasurer Conference Call Participants Phil Dantoin - Piper Sandler Ryan Zimmerman - BTIG Joshua Jennings - TD Cowen Suraj Kalia - Oppenheimer & Company Bruce Jackson - Benchmark Company Operator Good morning, ladies and gentlemen, and welcome to the Humacyte Fi ...
Humacyte(HUMA) - 2022 Q4 - Earnings Call Transcript
2023-03-27 18:46
Humacyte, Inc. (NASDAQ:HUMA) Q4 2022 Earnings Conference Call March 24, 2023 8:00 AM ET Company Participants Lauren Marek - LifeSci Advisors, Investor Relations Laura Niklason - President and Chief Executive Officer Dale Sander - Chief Financial Officer and Chief Corporate Development Officer Heather Prichard - Chief Operating Officer Conference Call Participants Ryan Zimmerman - BTIG Phillip Paul Dantoin - Piper Sandler Josh Jennings - TD Cowen Suraj Kalia - Oppenheimer Bruce Jackson - The Benchmark Compan ...
Humacyte(HUMA) - 2022 Q4 - Annual Report
2023-03-24 12:49
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ___________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-39532 Humacyte, Inc. (Exact name of registrant as specified in its charter) ___________________________________ (State or o ...