Humacyte, Inc.
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Gold Falls 1%; ProKidney Shares Spike Higher
Benzinga· 2025-07-08 17:25
Market Overview - U.S. stocks showed mixed performance with the Dow Jones index declining by 0.35% to 44,249.09, while the NASDAQ increased by 0.07% to 20,427.63 and the S&P 500 fell by 0.03% to 6,228.39 [1] - Energy shares experienced a notable increase of 2.1%, while utilities stocks decreased by 1.9% [1] Used Vehicle Market - The US Manheim Used Vehicle Value Index rose by 1.6% month-over-month for June, following a 1.4% decline in May [2][11] Commodity Market - Oil prices increased by 0.3% to $68.14, while gold prices decreased by 1.1% to $3,306.90. Silver fell by 0.8% to $36.625, and copper dropped by 0.5% to $5.0000 [5] European Market - European shares showed positive movement with the eurozone's STOXX 600 rising by 0.40%, Spain's IBEX 35 Index up by 0.10%, London's FTSE 100 gaining 0.46%, Germany's DAX 40 increasing by 0.68%, and France's CAC 40 rising by 0.46% [6] Asian Market - Asian markets closed higher, with Japan's Nikkei gaining 0.26%, Hong Kong's Hang Seng climbing 1.09%, China's Shanghai Composite increasing by 0.70%, and India's BSE Sensex rising by 0.32% [7] Company News - ENDRA Life Sciences Inc. saw its shares surge by 134% to $8.10 after announcing a US patent for a "Radio Frequency Applicator" [9] - ProKidney Corp. shares surged by 218% to $1.95 following positive topline results from its Phase 2 REGEN-007 trial for chronic kidney disease and diabetes [9] - Humacyte, Inc. shares increased by 20% to $2.5750 after receiving Electronic Catalog Listing approval from the US Defense Logistics Agency [9] - Blue Gold Limited shares dropped by 21% to $58.75 after announcing the formation of its inaugural Advisory Board for Blockchain Evolution [9] - Sunrun Inc. shares fell by 11% to $9.84 after President Trump signed an executive order to end clean-energy tax credits [9] - Apogee Therapeutics, Inc. shares decreased by 8% to $36.24 following the release of data from its Phase 2 APEX clinical trial for atopic dermatitis [9]
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 - 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 to Present Fourth Quarter and Full Year Financial Results and Provide Corporate Update on March 28, 2025
Globenewswire· 2025-03-26 12:00
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]
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]
Wall Street Bulls Look Optimistic About Humacyte, Inc. (HUMA): Should You Buy?
ZACKS· 2025-03-07 15:30
Core Viewpoint - Brokerage recommendations, particularly for Humacyte, Inc. (HUMA), show a strong bias towards positive ratings, which may not accurately reflect the stock's potential for price appreciation [4][5][9]. Brokerage Recommendations - Humacyte, Inc. has an average brokerage recommendation (ABR) of 1.29, indicating a consensus between Strong Buy and Buy, with 85.7% of the recommendations being Strong Buy from seven brokerage firms [2][4]. - Despite the positive ABR, relying solely on this information for investment decisions may not be advisable due to the historical ineffectiveness of brokerage recommendations in guiding investors [4][9]. Zacks Rank Comparison - The Zacks Rank, a proprietary stock rating tool, categorizes stocks from 1 (Strong Buy) to 5 (Strong Sell) and is based on earnings estimate revisions, which are more reliable indicators of near-term stock price movements [7][10]. - The Zacks Rank for Humacyte, Inc. is currently 4 (Sell), reflecting a 0.9% decline in the consensus earnings estimate to -$1.27 over the past month, indicating growing pessimism among analysts [12][13]. Analyst Optimism and Bias - Analysts from brokerage firms tend to exhibit overly optimistic ratings due to vested interests, often leading to a misalignment with retail investors' interests [5][6][9]. - The disparity between the ABR and Zacks Rank highlights the importance of using multiple tools for investment validation, as the ABR may not be timely or reflective of current market conditions [11].
Humacyte, Inc. (HUMA) Stock Slides as Market Rises: Facts to Know Before You Trade
ZACKS· 2025-03-06 00:00
Company Performance - Humacyte, Inc. (HUMA) closed at $3.15, reflecting a decline of -1.56% from the previous day's closing price, underperforming the S&P 500 which gained 1.12% [1] - The stock has decreased by 26.77% over the past month, contrasting with the Medical sector's gain of 0.4% and the S&P 500's loss of 4.13% [1] Earnings Forecast - The upcoming earnings release is anticipated, with predictions indicating an EPS of -$0.24, showing no change compared to the same quarter last year [2] Analyst Estimates - Recent changes to analyst estimates for Humacyte, Inc. are important, as they reflect short-term business trends and can indicate analyst optimism regarding the company's profitability [3] - The Zacks Consensus EPS estimate has decreased by 0.91% over the last 30 days, and Humacyte, Inc. currently holds a Zacks Rank of 4 (Sell) [5] Industry Overview - The Medical - Biomedical and Genetics industry, part of the Medical sector, has a Zacks Industry Rank of 73, placing it in the top 30% 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 to Host In-Person and Virtual Investor Event in New York to Discuss Commercial Launch of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma on March 6, 2025
GlobeNewswire News Room· 2025-03-03 13:00
Core Viewpoint - Humacyte, Inc. is hosting an investor event to discuss the commercial plans and early market-launch success of its bioengineered human tissue product, Symvess, for extremity arterial injury [1][2][3] Company Overview - Humacyte, Inc. is a biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][7] - The company aims to improve patient lives and transform medical practices through its advanced tissue constructs and organ systems [7] Product Details - Symvess is a first-in-class bioengineered human tissue designed as a vascular conduit for arterial replacement and repair [3] - The FDA granted full approval for Symvess in December 2024 for use in adults facing imminent limb loss due to extremity arterial injury when autologous vein grafts are not feasible [3] Event Information - The investor event will take place on March 6, 2025, featuring key opinion leaders in vascular surgery and company management [1][2] - A live Q&A session will follow the formal presentations, with a replay available on Humacyte's website [4] Clinical and Regulatory Milestones - Humacyte's acellular tissue engineered vessels (ATEVs) are in late-stage clinical trials targeting various vascular applications, including vascular trauma repair and arteriovenous access for hemodialysis [7][8] - The ATEV for urgent arterial repair received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense [8]