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Humacyte, Inc. (HUMA) Q4 2024 Earnings Conference Call Transcript
Seeking Alpha· 2025-03-28 17:48
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].
Humacyte(HUMA) - 2025 4 - Earnings Call Transcript
2025-03-28 12:30
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]
Humacyte(HUMA) - 2024 Q4 - Annual Results
2025-03-28 11:55
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™ ...
Humacyte Announces Fourth Quarter and Year End 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-03-28 11:30
- 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 ...
Brokers Suggest Investing in Humacyte, Inc. (HUMA): Read This Before Placing a Bet
ZACKS· 2025-03-26 14:30
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 ...
Humacyte to Present Fourth Quarter and Full Year Financial Results and Provide Corporate Update on March 28, 2025
Globenewswire· 2025-03-26 12:00
DURHAM, N.C., March 26, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the fourth quarter and year ended December 31, 2024, on Friday, March 28, 2025. Management will host a webcast and conference call at 8:30 a.m. ET. Title:Humacyte Fourth Quarter and Full Year 2024 Financial Results and Corporate UpdateDate:March 28, 2025Time:8: ...
Humacyte, Inc. Announces Pricing of Public Offering of Common Stock
Globenewswire· 2025-03-26 00:35
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].
Humacyte, Inc. Announces Proposed Public Offering of Common Stock
Newsfilter· 2025-03-25 20:01
Core Viewpoint - Humacyte, Inc. has initiated an underwritten public offering of its common stock to fund the commercialization of its product SYMVESS™ and other developmental projects [1][3] Group 1: Offering Details - Humacyte is offering shares of common stock and has granted underwriters a 30-day option to purchase an additional 15% of the shares sold [1] - The offering is managed by TD Cowen, Barclays, and BTIG as joint book-running managers, with H.C. Wainwright & Co. and The Benchmark Company as lead managers [2] - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [2] Group 2: Use of Proceeds - The net proceeds from the offering will be used for the commercialization of SYMVESS™ in vascular trauma, development of product candidates, and general corporate purposes [3] Group 3: Company Overview - Humacyte is focused on developing bioengineered human tissues and advanced tissue constructs to improve patient outcomes [6] - The company’s initial product candidates, acellular tissue engineered vessels (ATEVs), are in late-stage clinical trials for various vascular applications [6] - The ATEV for vascular trauma received FDA approval in December 2024, and the company is also pursuing preclinical development for other applications [6][7]
Humacyte, Inc. (HUMA) Flat As Market Gains: What You Should Know
ZACKS· 2025-03-24 23:05
Company Overview - Humacyte, Inc. (HUMA) closed at $3.32, showing no change from the previous day's closing price, which is less than the S&P 500's daily gain of 1.77% [1] - The stock has decreased by 6.21% over the past month, underperforming compared to the Medical sector's loss of 1.17% and the S&P 500's loss of 5.73% [1] Earnings Expectations - The upcoming earnings release is anticipated, with an expected EPS of -$0.23, reflecting a 4.17% increase from the same quarter last year [2] - Recent changes in analyst estimates are crucial for investors, as positive revisions indicate confidence in the company's performance and profit potential [2] Analyst Ratings - The Zacks Rank system, which ranges from 1 (Strong Buy) to 5 (Strong Sell), currently ranks Humacyte, Inc. at 4 (Sell) [4] - Over the past month, the Zacks Consensus EPS estimate has decreased by 0.91% [4] Industry Context - Humacyte operates within the Medical - Biomedical and Genetics industry, which holds a Zacks Industry Rank of 74, placing it in the top 30% of over 250 industries [5] - The Zacks Industry Rank evaluates the strength of industry groups based on the average Zacks Rank of individual stocks, with top-rated industries outperforming the bottom half by a factor of 2 to 1 [5]
Humacyte Announces Publication of the Budget Impact Model (BIM) for Symvess™ (acellular tissue engineered vessel-tyod) in the Journal of Medical Economics
Globenewswire· 2025-03-10 12:00
– Symvess is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair – – Publication of the Budget Impact Model in peer-reviewed journal supports Symvess as a treatment that provides economic value to hospitals and payers – DURHAM, N.C., March 10, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, t ...