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All You Need to Know About Humacyte, Inc. (HUMA) Rating Upgrade to Buy
ZACKS· 2025-04-30 17:00
Core Viewpoint - Humacyte, Inc. (HUMA) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, indicating a positive outlook for the company's stock price [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often rely on earnings estimates to determine the fair value of a company's shares, leading to significant stock price movements when estimates are revised [4]. Recent Performance and Projections - For the fiscal year ending December 2025, Humacyte, Inc. is expected to earn -$0.69 per share, reflecting a 34.3% change from the previous year's reported number [8]. - Over the past three months, the Zacks Consensus Estimate for Humacyte has increased by 16.9%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - Humacyte's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].
Humacyte, Inc. (HUMA) Ascends But Remains Behind Market: Some Facts to Note
ZACKS· 2025-04-24 23:00
Company Performance - Humacyte, Inc. closed at $1.48, with a daily increase of +0.68%, underperforming the S&P 500's gain of 2.03% [1] - Over the past month, Humacyte's shares have decreased by 26.5%, compared to the Medical sector's loss of 8.57% and the S&P 500's loss of 5.07% [1] Earnings Expectations - The upcoming earnings report for Humacyte is anticipated to show an EPS of -$0.19, which represents a 34.48% increase from the same quarter last year [2] Analyst Estimates - Recent changes in analyst estimates for Humacyte indicate a positive outlook, reflecting analysts' confidence in the company's business performance and profit potential [3] - The Zacks Consensus EPS estimate has increased by 10.48% over the last 30 days, suggesting a favorable trend in analyst sentiment [5] Industry Context - Humacyte operates within the Medical - Biomedical and Genetics industry, which currently holds a Zacks Industry Rank of 79, placing it in the top 32% of over 250 industries [6] - The Zacks Industry Rank measures the strength of industry groups, indicating that the top 50% rated industries tend to outperform the bottom half by a factor of 2 to 1 [6]
Humacyte, Inc. (HUMA) Increases Despite Market Slip: Here's What You Need to Know
ZACKS· 2025-04-16 23:20
Company Overview - Humacyte, Inc. (HUMA) closed at $1.55, reflecting a +0.65% change from the previous session, outperforming the S&P 500's loss of 2.24% on the same day [1] - Over the past month, shares of Humacyte have depreciated by 50.8%, significantly underperforming the Medical sector's loss of 7.47% and the S&P 500's loss of 4.17% [1] Financial Performance Expectations - Analysts expect Humacyte to report earnings of -$0.19 per share in the upcoming financial results, indicating a year-over-year growth of 34.48% [2] - The Zacks Consensus EPS estimate for Humacyte has increased by 10.48% over the past month [5] Analyst Sentiment and Estimates - Recent changes to analyst estimates for Humacyte reflect short-term business trends, with positive revisions indicating analysts' confidence in the company's performance and profit potential [3] - Humacyte currently holds a Zacks Rank of 3 (Hold), which is part of a ranking system that has historically delivered an average annual return of +25% for stocks rated 1 [5] Industry Context - Humacyte operates within the Medical - Biomedical and Genetics industry, which holds a Zacks Industry Rank of 75, placing it in the top 31% of over 250 industries [6] - Research indicates that the top 50% rated industries outperform the bottom half by a factor of 2 to 1 [6]
Humacyte(HUMA) - 2024 Q4 - Annual Report
2025-03-31 20:31
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, 2024 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) ___________________________________ (St ...
Humacyte(HUMA) - 2024 Q4 - Earnings Call Transcript
2025-03-28 20:23
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]
Humacyte(HUMA) - 2024 Q4 - Earnings Call Transcript
2025-03-28 17:48
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]
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 ...