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Humacyte(HUMA) - 2025 Q1 - Quarterly Results
2025-05-13 11:36
Financial Performance - Total revenues for Q1 2025 were $517,000, with $147,000 from the initial U.S. commercial launch of Symvess and $370,000 from a research collaboration[11]. - Net income for Q1 2025 was $39.1 million, compared to a net loss of $31.9 million in Q1 2024, largely due to a non-cash remeasurement of the contingent earnout liability[11]. - Total revenue for Q1 2025 was $517,000, compared to $0 in Q1 2024, indicating a significant growth[27]. - Product revenue was $147,000, while contract revenue was $370,000, both contributing to the total revenue[27]. - Operating expenses decreased to $23,701,000 in Q1 2025 from $26,578,000 in Q1 2024, reflecting a reduction of approximately 11%[27]. - The net income for Q1 2025 was $39,139,000, a turnaround from a net loss of $31,896,000 in Q1 2024[27]. - Net income per share, basic, was $0.28 in Q1 2025, compared to a loss of $0.29 per share in Q1 2024[27]. Cash and Assets - As of March 31, 2025, Humacyte reported cash, cash equivalents, and restricted cash of $113.2 million[11]. - Cash and cash equivalents increased to $62,847,000 as of March 31, 2025, up from $44,937,000 at the end of 2023[29]. - Total assets rose to $162,553,000 as of March 31, 2025, compared to $137,872,000 at the end of 2023, marking an increase of approximately 18%[29]. - Total liabilities decreased significantly to $126,510,000 from $190,541,000, indicating a reduction of about 34%[29]. - Stockholders' equity improved to $36,043,000 as of March 31, 2025, compared to a deficit of $52,669,000 at the end of 2023[29]. Cost Management - The company implemented cost reduction measures, including a workforce reduction of approximately 31 employees, expected to save about $13.8 million in 2025 and up to $38.0 million in 2026[7]. - Research and development expenses for Q1 2025 were $15.4 million, down from $21.3 million in Q1 2024, primarily due to decreased materials costs[11]. Product Development and Market Approval - 45 hospitals have initiated the Value Analysis Committee (VAC) approval process for Symvess, with five hospitals already approving its purchase[4]. - A total of 84 patients have been enrolled in the V012 Phase 3 clinical trial for dialysis, with an interim analysis planned upon reaching the one-year follow-up for the first 80 patients[8]. - Humacyte plans to file an Investigational New Drug (IND) application with the FDA for first-in-human clinical testing of the small-diameter ATEV in coronary artery bypass grafting (CABG) later this year[8]. Economic Value - The economic value of Symvess is projected to be lower than that of synthetic grafts, with significant cost savings attributed to reduced amputation and infection rates[8]. - The company reported a change in fair value of contingent earnout liability of $49,731,000 in Q1 2025, compared to a loss of $4,593,000 in Q1 2024[27].
Humacyte Announces First Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-05-13 11:30
Core Insights - Humacyte, Inc. has successfully launched its product Symvess™ for treating extremity vascular trauma, marking a significant milestone for the company [2][3] - The company reported total revenues of $517,000 for the first quarter of 2025, with $147,000 from the initial commercial sales of Symvess and $370,000 from a research collaboration [9][27] - Humacyte completed a public offering that raised $46.7 million in net proceeds, which will help extend its cash runway [6][9] Market Launch and Sales - The commercial launch of Symvess began in late February 2025, with initial shipments to three Level 1 trauma centers [3] - 45 hospitals have initiated the Value Analysis Committee (VAC) approval process for Symvess, with five hospitals already approving its purchase [2][3] - The company anticipates further approvals and sales growth in the upcoming quarters [3] Financial Performance - The first quarter of 2025 saw a revenue increase to $517,000 compared to no revenue in the same period of 2024 [9][27] - Research and development expenses decreased to $15.4 million from $21.3 million year-over-year, attributed to reduced material costs and clinical study expenses [9][27] - General and administrative expenses rose to $8.1 million from $5.3 million, primarily due to the costs associated with the commercial launch of Symvess [9][27] Cost Management and Future Plans - The company implemented cost reduction measures, including workforce reductions and deferring new hires, aiming for estimated savings of approximately $13.8 million in 2025 and up to $38 million in 2026 [6][9] - Humacyte plans to file an Investigational New Drug (IND) application with the FDA for the small-diameter ATEV™ in coronary artery bypass grafting (CABG) later this year [2][8] - The company is on track to submit a supplemental Biologics License Application (BLA) for ATEV in dialysis in 2026, following a major enrollment milestone in its Phase 3 trial [2][8] Corporate Developments - Humacyte was issued a new U.S. patent in January 2025, providing protection for its biomanufacturing platform until 2040 [4] - The company reported a net income of $39.1 million for the first quarter of 2025, a significant improvement from a net loss of $31.9 million in the same period of 2024 [17][27] - As of March 31, 2025, Humacyte had cash, cash equivalents, and restricted cash totaling $113.2 million [17][28]
Humacyte to Present First Quarter Financial Results and Provide Corporate Update on May 13, 2025
GlobeNewswire News Room· 2025-05-09 12:00
Core Viewpoint - Humacyte, Inc. is set to release its financial results for Q1 2025 on May 13, 2025, and will provide a corporate and financial update during a webcast and conference call [1][2]. Company Overview - Humacyte, Inc. is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][3]. - The company manufactures acellular tissues aimed at treating various diseases, injuries, and chronic conditions [3]. - The FDA approved the Biologics License Application for Humacyte's acellular tissue engineered vessel (ATEV) for vascular trauma in December 2024 [3]. - ATEVs are currently in late-stage clinical trials for additional vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [3]. - Preclinical development is ongoing for coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes treatment, and other novel cell and tissue applications [3]. - Humacyte's 6mm ATEV for AV access in hemodialysis is notable for being the first product to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received Fast Track designation [3]. - The ATEV has received priority designation for vascular trauma treatment from the U.S. Secretary of Defense [3]. Financial Results Announcement - The financial results for the quarter ended March 31, 2025, will be announced on May 13, 2025, at 8:30 AM ET [2]. - A conference call will be available for U.S. and international investors, with specific dial-in numbers provided [2]. - The webcast will be accessible 15 minutes prior to the call and will be available for replay for at least 30 days [2].
Humacyte, Inc. (HUMA) Beats Stock Market Upswing: What Investors Need to Know
ZACKS· 2025-04-30 23:05
Company Performance - Humacyte, Inc. (HUMA) ended the latest trading session at $1.45, reflecting a +1.4% adjustment from the previous day's close, outperforming the S&P 500 which gained 0.15% [1] - The stock has decreased by 4.03% over the past month, which is worse than the Medical sector's loss of 4.39% and the S&P 500's loss of 0.21% [1] Earnings Forecast - Humacyte, Inc. is projected to report earnings of -$0.19 per share in the upcoming release, indicating a year-over-year growth of 34.48% [2] Analyst Revisions - Recent revisions to analyst forecasts for Humacyte, Inc. are important as they reflect changes in short-term business dynamics, with positive revisions indicating analysts' confidence in the company's performance [3] Zacks Rank System - The Zacks Rank system, which ranges from 1 (Strong Buy) to 5 (Strong Sell), has a strong track record, with 1 stocks averaging an annual return of +25% since 1988 [5] - Over the last 30 days, the Zacks Consensus EPS estimate for Humacyte, Inc. has increased by 14.6%, and the company currently holds a Zacks Rank of 2 (Buy) [5] Industry Context - Humacyte, Inc. operates within the Medical - Biomedical and Genetics industry, which has a Zacks Industry Rank of 78, placing it in the top 32% 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]
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
Humacyte (HUMA) Q4 2024 Earnings Call March 28, 2025 04:23 PM ET Company Participants Tom Johnson - Director - Corporate CommunicationsLaura Niklason - Founder, President, CEO & DirectorDale Sander - CFO, Chief Corporate Development Officer & TreasurerJoshua Jennings - Managing DirectorVernon Bernardino - Managing Director Conference Call Participants Ryan Zimmerman - Managing Director & Medical Technology AnalystNone - AnalystBruce Jackson - Senior Analyst Operator morning, ladies and gentlemen, and welcom ...
Humacyte(HUMA) - 2024 Q4 - Earnings Call Transcript
2025-03-28 17:48
Humacyte, Inc. (NASDAQ:HUMA) Q4 2024 Earnings Conference Call March 27, 2025 8:30 AM ET Company Participants Thomas Johnson - Director, Corporate Communications, LifeSci Advisors, IR Laura Niklason - President and CEO Dale Sander - CFO and Chief Corporate Development Officer Conference Call Participants Josh Jennings - TD Cowen & Company Ryan Zimmerman - BTIG Vernon Bernardino - H.C. Wainwright Bruce Jackson - Benchmark Company Operator Good morning, ladies and gentlemen. Welcome to the Humacyte Fourth Quar ...