Product Launch and Approvals - Humacyte commenced the U.S. commercial launch of its first FDA-approved product, Symvess™, in Q1 2025, targeting the vascular repair market[17]. - The FDA granted full approval for Symvess™ on December 19, 2024, for use in adults as a vascular conduit for extremity arterial injury[20]. - The FDA granted full approval for ATEV on December 19, 2024, for use in adults with extremity vascular trauma when autologous vein grafts are not feasible[98]. - A New Technology Add-On Payment (NTAP) application for Symvess was submitted to CMS in October 2024, with potential reimbursement starting on October 1, 2025[213]. Clinical Trials and Results - As of December 31, 2024, approximately 601 patients have received ATEVs, with ongoing Phase 3 and Phase 2 trials for AV access in hemodialysis and PAD[19]. - The V007 Phase 3 trial for dialysis access met co-primary endpoints, with topline results expected in August 2024[56]. - The ATEV has shown a 30-day primary patency rate of 95% in the V001 trial for dialysis access, with a 0% infection rate per year[56]. - The V005 Phase 2/3 trial demonstrated a primary patency rate of 84.3% for ATEVs compared to 78.9% for synthetic grafts, and a secondary patency rate of 90.2% versus 78.9%[77]. - The V011 clinical trial for dialysis access completed with a 30-day primary patency rate of 97% and a 12-month secondary patency rate of 83%[23]. - The V006 trial achieved a 30-day primary patency of 93% and a 12-month secondary patency of 82%, with an infection rate of 0.93% per year[115]. - The V002 trial reported a secondary patency rate of 60% at 72 months, with no infections or amputations reported[168]. - The V004 trial showed a secondary patency of 86% at 6 months and 64% at 12 months, with no reported infections or amputations[173]. Manufacturing and Production - Humacyte's manufacturing facility spans 83,000 square feet and can accommodate over 40 LUNA200 systems, currently operating eight systems[33]. - The LUNA200 system can produce up to 200 ATEVs (42cm in length) per batch, with the ability to generate 400 ATEVs (13cm in length) per batch[35]. - The ATEV manufacturing process utilizes primary human aortic vascular cells, with each qualified isolation capable of producing approximately 500,000 to 1 million ATEVs[205]. - The LUNA200 system can produce up to 200 ATEVs per batch, with an annual gross capacity of approximately 7,200 ATEVs from eight installed systems[204]. Patient Population and Market Potential - The estimated annual eligible patient population for ATEVs in the U.S. is approximately 26,000, based on trauma injury analysis[41]. - In 2024, over 555,000 patients received hemodialysis in the U.S., with at least 160,000 requiring new AV access annually[43]. - Over 230,000 peripheral artery disease-related procedures are reported annually in the U.S., with significant potential for ATEVs as bypass conduits[46]. - Approximately 1,800 babies are born with Tetralogy of Fallot in the U.S. each year, and the company plans to submit an orphan drug application for ATEV use as a BT shunt[53]. Safety and Efficacy - The ATEV has shown a low infection rate of approximately 1.0% or less per patient-year in AV access trials, with rates in trauma and PAD trials ranging from 0% to approximately 2%[60]. - The ATEV has demonstrated maximal pressure withstand capabilities of approximately 3,200 mmHg, comparable to native human blood vessels[36]. - The ATEV has shown strong patency rates and no reported infections in clinical studies for PAD, supporting its development as a bypass conduit[161]. - The ATEV demonstrated a statistically significant lower rate of conduit infections compared to ePTFE, highlighting its safety advantage[126]. Financial and Strategic Considerations - The ATEVs are projected to be cost-saving for trauma centers and third-party payors, primarily due to reductions in costs related to amputations and conduit infections[42]. - A Budget Impact Model indicates that the per-patient cost of treating with Symvess is expected to be lower than current treatments, with significant cost savings attributed to reduced amputation and infection rates[212]. - The company received approximately $6.8 million in grants from the Department of Defense for the development of ATEVs for vascular reconstruction and repair[70]. - The ATEV technology has been designated as a priority by the DoD, expediting its development and review process[70]. Partnerships and Collaborations - A distribution agreement with Fresenius Medical Care grants exclusive rights to develop and commercialize the 6mm x 42cm ATEV outside the U.S. and EU, with collaboration for U.S. commercialization[215]. - The agreement with Fresenius Medical Care includes responsibilities for regulatory approval in the U.S. and efforts to meet market entry criteria in other countries[216]. - The company anticipates exploring strategic partnerships for earlier-stage applications of its technology platform, such as CABG and BVP for diabetes, as clinical results are generated[214].

Financial Data and Key Metrics Changes - No revenue was reported for the fourth quarter of 2024 or 2023, and no revenue was recorded for the years ended December 31, 2024, and 2023. However, commercial revenues have started to be booked for the first time in the company's history within the last several weeks [23] - Research and development expenses for the fourth quarter of 2024 were $20.7 million, a decrease from $22.9 million in the third quarter of 2024, but a slight increase from $20.2 million in the fourth quarter of 2023. For the year ended December 31, 2024, R&D expenses were $88.6 million, compared to $76.6 million in 2023 [24] - General and administrative expenses for the fourth quarter of 2024 were $7.4 million, consistent with the third quarter of 2024, and increased from $6 million in the fourth quarter of 2023. Total G&A expenses for the year ended December 31, 2024, were $25.8 million, compared to $23.5 million in 2023 [25] - Net loss for the fourth quarter of 2024 was $20.9 million, down from $39.2 million in the third quarter of 2024 and $25.1 million in the fourth quarter of 2023. The net loss for the year ended December 31, 2024, was $148.7 million, compared to $110.8 million in 2023 [28] - Cash, cash equivalents, and restricted cash totaled $95.3 million as of December 31, 2024, with an additional $46.6 million raised from a public offering completed shortly after [29] Business Line Data and Key Metrics Changes - The commercial launch of Symvess is proceeding at full speed, with 34 hospitals initiating their Value Analysis Committee (VAC) approval process. Three hospitals have already approved the purchase of Symvess [9][10] - The ATEV program for dialysis access has shown superior function and patency compared to AV fistula in clinical trials, with plans to submit a supplemental BLA in the second half of 2026 [18][20] Company Strategy and Development Direction - The company aims to drive adoption of Symvess through a highly experienced sales team, focusing on both civilian and military healthcare providers [16][17] - The company is committed to expanding its pipeline, including the ATEV program and small diameter ATEV for coronary artery bypass grafting, with plans for IND application filing [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the transformative potential of Symvess and its impact on patient outcomes, emphasizing the importance of commercial execution and pipeline programs [31] - The management acknowledged the challenges of the VAC approval process but remains optimistic about the adoption of Symvess in trauma centers [41][42] Other Important Information - A new U.S. patent covering key aspects of the manufacturing system for Symvess was issued, providing protection until 2040 [14] - The company has published a Budget Impact Model indicating cost reductions associated with the use of Symvess in traumatic injury [12] Q&A Session Summary Question: Characteristics of hospitals that approved Symvess - Management noted that approvals were driven by hospitals committed to improving patient care and having surgeon champions advocating for the product [35][36] Question: Goals for the launch in 2025 - Management refrained from providing specific guidance but indicated a strong start with ongoing VAC processes and expected sales growth in the second half of the year [40][44] Question: Feedback from surgeons regarding a controversial article - Surgeons involved in clinical trials expressed strong discontent with the article, drafting a rebuttal that was not published by the New York Times [49][50] Question: Interim analysis for the V012 trial - The interim analysis will focus on catheter-free days during the first year, with expectations for positive results based on previous data [60] Question: Supplemental BLA review timeline - Management hopes for a shorter review time for the supplemental BLA compared to the initial application, but acknowledges the unpredictability of FDA timelines [90] Question: Cost of manufacturing small diameter ATEV - The cost of producing smaller diameter ATEV is expected to be less than that of larger sizes, with no need for new equipment [95]

Financial Data and Key Metrics Changes - No revenue was reported for the fourth quarter of 2024 or 2023, and no revenue for the years ended December 31, 2024, and 2023. However, commercial revenues have started to be booked for the first time in the company's history within the last several weeks [23] - Research and development expenses were $20.7 million for the fourth quarter of 2024, a decrease from $22.9 million in the third quarter of 2024, but a slight increase from $20.2 million in the fourth quarter of 2023. For the year ended December 31, 2024, R&D expenses were $88.6 million compared to $76.6 million in 2023 [24] - General and administrative expenses were $7.4 million for the fourth quarter of 2024, consistent with the previous quarter, but an increase from $6 million in the fourth quarter of 2023. Total G&A expenses for the year were $25.8 million compared to $23.5 million in 2023 [25] - Net loss was $20.9 million for the fourth quarter of 2024, down from $39.2 million in the third quarter of 2024 and $25.1 million in the fourth quarter of 2023. The net loss for the year was $148.7 million compared to $110.8 million in 2023 [28] Business Line Data and Key Metrics Changes - The commercial launch of Symvess is proceeding at full speed, with 34 hospitals initiating their Value Analysis Committee (VAC) approval process. Three hospitals have already approved the purchase of Symvess [9][10] - The ATEV program for dialysis access has shown superior function and patency compared to AV fistula in clinical trials, with plans for a supplemental BLA submission in the second half of 2026 [18][20] Market Data and Key Metrics Changes - The market response to Symvess has been positive, with hospitals engaged in the VAC process and early commercial shipments made to Level 1 trauma centers [9][10] - A Budget Impact Model published in the Journal of Medical Economics indicates that the use of Symvess can lead to cost reductions associated with avoiding vascular infections and amputations [12] Company Strategy and Development Direction - The company aims to drive adoption of Symvess through a highly experienced sales team and is focused on expanding its pipeline, including the ATEV program and small diameter ATEV for coronary artery bypass grafting [16][20] - The company is committed to delivering transformative regenerative medicine solutions and improving patient outcomes, with a strong emphasis on commercial execution and pipeline development [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial strategy and the potential impact of Symvess on vascular patient care, anticipating a significant year ahead [31] - The company is evaluating its cash position and prioritizing investments for future trials, particularly for the PAD program [75] Other Important Information - The company completed a public offering of common stock that provided approximately $46.6 million in additional net proceeds [29] - A new U.S. patent covering key aspects of the manufacturing system for Symvess was issued, providing protection until 2040 [14] Q&A Session Summary Question: Characteristics of hospitals that approved Symvess - Management noted that the speed of VAC approvals is influenced by hospitals committed to improving patient care and having surgeon champions advocating for the product [35][36] Question: Goals for the U.S. launch in 2025 - Management provided estimates that many Level 1 trauma centers would initiate the VAC process by the end of the year, with projected sales between $7 million and $13 million, primarily in the second half of the year [40][43] Question: Feedback from surgeons regarding a controversial article - Surgeons involved in clinical trials expressed strong discontent with the article, drafting a rebuttal that was not published by the New York Times [49][50] Question: Interim analysis for the V012 trial - The interim analysis will focus on catheter-free days during the first year, with expectations for positive results based on previous data [60] Question: Supplemental BLA submission timeline - Management hopes for a shorter review time for the supplemental BLA compared to the initial application, aiming for priority review [90] Question: Cost of manufacturing small diameter ATEV - The cost of producing smaller diameter ATEV is expected to be less than that of larger sizes, with no need for new equipment [95] Question: Update on the biovascular pancreas project - The company is continuing primate studies, showing long-term insulin production and survival of islets, with ongoing adjustments to maximize therapeutic effects [100][102]

Core Viewpoint - Humacyte is conducting a conference call to discuss its fourth quarter results, with key executives participating to provide insights into the company's performance and future outlook [1][6]. Group 1: Company Overview - The call features Dr. Laura Niklason, President and CEO, and Dale Sander, CFO and Chief Corporate Development Officer, who will summarize major events for the company [6]. Group 2: Conference Call Structure - The conference call is structured to include a question-and-answer session after the initial presentations, with all participants currently in listen-only mode [1]. - The call is being recorded for future reference [1]. Group 3: Forward-Looking Statements - The company has made forward-looking statements that are subject to risks and uncertainties, which could lead to actual results differing from expectations [4]. - The company will not update these forward-looking statements unless required by law, and additional information can be found in their periodic reports filed with the SEC [5].

Financial Data and Key Metrics Changes - There was no revenue for the fourth quarter of 2024 or 2023, and no revenue for the years ended December 31, 2024, and 2023. However, commercial revenues have started to be booked for the first time in the company's history within the last several weeks [26][31] - Research and development expenses were $20.7 million for the fourth quarter of 2024, a decrease from $22.9 million in the third quarter of 2024, but a slight increase from $20.2 million in the fourth quarter of 2023 [26][27] - General and administrative expenses were $7.4 million for the fourth quarter of 2024, consistent with the previous quarter, but an increase from $6 million in the fourth quarter of 2023 [29] - Net loss was $20.9 million for the fourth quarter of 2024, compared to $39.2 million in the third quarter of 2024 and $25.1 million in the fourth quarter of 2023 [31] - Cash, cash equivalents, and restricted cash totaled $95.3 million as of December 31, 2024, with an additional $46.6 million raised from a public offering shortly after [32] Business Line Data and Key Metrics Changes - The commercial launch of SimVest is proceeding well, with 34 hospitals initiating their Value Analysis Committee (VAC) approval process, and three hospitals already approving the purchase [9][10] - The budget impact model published in the Journal of Medical Economics supports the cost-effectiveness of SimVest compared to other treatment options [11] Market Data and Key Metrics Changes - The market response to SimVest has been positive, with hospitals engaged in the VAC process, indicating strong interest from leading trauma centers and newly introduced institutions [9][10] Company Strategy and Development Direction - The company is focused on expanding the adoption of SimVest and is optimistic about its potential impact on vascular surgery [8][35] - Plans to submit a supplemental BLA for the ATEV program in dialysis access in the second half of 2026, with expectations for positive interim results from ongoing clinical trials [21][67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial execution and the promising pipeline programs, anticipating a positive impact on patient care in the coming years [35] - The company is aware of the challenges in the market but remains committed to driving adoption and addressing any concerns raised by the medical community [54][56] Other Important Information - A new U.S. patent was issued for key aspects of the manufacturing system for SimVest, providing protection until 2040 [14] - The company is evaluating its cash position and priorities for future trials, particularly for the PADD program [82][84] Q&A Session Summary Question: Characteristics of the three hospitals that approved SimVest - Management noted that approvals were driven by hospitals committed to improving patient care and having surgeon champions advocating for the product [41][42] Question: Goals for the launch in 2025 - Management provided estimates that many level one trauma centers would initiate the VAC process by the end of the year, with expected sales between $7 million and $13 million [46][49] Question: Feedback from surgeons regarding a recent article - Surgeons involved in clinical trials expressed strong discontent with the article, drafting a rebuttal that was not published by the New York Times [54][55] Question: Interim analysis for the VO12 trial - The interim analysis aims to establish catheter-free days for women undergoing dialysis, with positive expectations based on previous data [66][67] Question: Supplemental BLA submission timeline - Management hopes for a shorter review time for the supplemental BLA compared to the initial application, aiming for priority review [97] Question: Cost of manufacturing small diameter ATEV - The cost of producing smaller diameter vessels is expected to be less than larger ones, utilizing existing manufacturing equipment [101][103] Question: Update on the biovascular pancreas project - The project is progressing well in primate studies, showing long-term insulin production and survival of islets [108][110]

Exhibit 99.1 Humacyte Announces Fourth Quarter and Year End 2024 Financial Results and Provides Business Update - Received U.S. Food and Drug Administration (FDA) approval of Symvess™ (acellular tissue engineered vessel-tyod) for the treatment of extremity vascular trauma - - Commenced market launch and first commercial sales of Symvess - - Budget Impact Model for Symvess published in Journal of Medical Economics - - IND filing planned in 2025 to support first-in-human clinical study of small-diameter ATEV™ ...

- Received U.S. Food and Drug Administration (FDA) approval of Symvess™ (acellular tissue engineered vessel-tyod) for the treatment of extremity vascular trauma - - Commenced market launch and first commercial sales of Symvess -  - Budget Impact Model for Symvess published in Journal of Medical Economics - - IND filing planned in 2025 to support first-in-human clinical study of small-diameter ATEV™ for coronary artery bypass grafting - - Conference call today at 8:30am ET - DURHAM, N.C., March 28, 2025 (GLO ...

The recommendations of Wall Street analysts are often relied on by investors when deciding whether to buy, sell, or hold a stock. Media reports about these brokerage-firm-employed (or sell-side) analysts changing their ratings often affect a stock's price. Do they really matter, though?Let's take a look at what these Wall Street heavyweights have to say about Humacyte, Inc. (HUMA) before we discuss the reliability of brokerage recommendations and how to use them to your advantage.Humacyte, Inc. currently ha ...

Core Insights - Humacyte, Inc. is set to release its financial results for Q4 and the full year of 2024 on March 28, 2025, with a conference call scheduled for 8:30 AM ET [1][2] Company Overview - Humacyte is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][3] - The company has received FDA approval for its acellular tissue engineered vessel (ATEV) for extremity vascular trauma in December 2024 and is conducting late-stage clinical trials for other vascular applications [3] - Humacyte's ATEV has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations, highlighting its potential in urgent arterial repair and advanced peripheral artery disease [3] Upcoming Events - The financial results webcast will be accessible 15 minutes prior to the conference call, with a replay available for at least 30 days on the company's investor website [2]

Core Viewpoint - Humacyte, Inc. has announced a public offering of 25 million shares at a price of $2.00 per share, aiming to raise approximately $50 million for commercialization and development purposes [1][2]. Group 1: Offering Details - The public offering consists of 25,000,000 shares priced at $2.00 each, with expected gross proceeds of $50 million before expenses [1]. - The offering is expected to close around March 27, 2025, pending customary closing conditions [1]. - Underwriters have a 30-day option to purchase an additional 3,750,000 shares at the public offering price [1]. Group 2: Use of Proceeds - Humacyte plans to use the net proceeds from the offering to fund the commercialization of its product SYMVESS™ for vascular trauma, develop product candidates in its pipeline, and for working capital and general corporate purposes [2]. Group 3: Company Background - Humacyte is focused on developing bioengineered human tissues and advanced tissue constructs to improve patient outcomes [5]. - The company’s initial product candidates, acellular tissue engineered vessels (ATEVs), are in late-stage clinical trials for various vascular applications [5]. - ATEV received FDA approval for vascular trauma in December 2024 and has also received RMAT and Fast Track designations for other applications [5].