Machine learning predictions based on historical earnings data and price patterns
1-Day Prediction
-3.71%
$0.09
0% positive prob.
5-Day Prediction
-16.74%
$0.08
0% positive prob.
20-Day Prediction
-24.18%
$0.07
0% positive prob.
SEC 8-K filings with transcript text
Mar 19, 2026 · 100% conf.
1D
-3.71%
$0.09
Act: -7.31%
5D
-16.74%
$0.08
Act: -7.31%
20D
-24.18%
$0.07
Act: -21.53%
2 tm269106d1_ex99-1.htm
Exhibit 99.1
Universally Implantable Regenerative Human Tissue
2 Disclaimer These slides and the accompanying oral presentation contain forward-looking statements. All statements, other than statements of historical fact, included in these slides and the accompanying oral presentation are forward-looking statements reflecting management’s current beliefs and expectations. In some cases, you can identify
terminology. Forward-looking statements in these slides and the accompanying oral presentation include, but are not limited to, statements about our plans and ability to commercialize our bioengineered acellular tissue engineered vessels (“ATEV s”) in the United States under the brand name Symvess in vascular trauma repair; the anticipated commercialization of our ATEVs and our ability to manufacture ATEVs and other product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our plans, anticipated timelines and ability to obtain marketing approval from the U.S. Food and Drug Administration (“FDA”) and other regulatory authorities, including the European Medicines Agency and Israel, for our ATEVs in other indications and other product candidates; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned preclinical and clinical trials; the outcome of our ongoing discussions with the FDA concerning the design of our clinical trials; our anticipated growth rate and market opportunities; the potential liquidity and trading of our securities; our ability to raise additional capital in the future; our ability to use our proprietary scientific technology platform to build a pipeline of additional product candidates; the anticipated characteristics and performance of our ATEVs; the expected size of the target populations and addressable markets for our product candidates; the anticipated benefits of our ATEVs relative to existing alternatives; our assessment of the competitive landscape; the degree of market acceptance of ATEVs and the availability of third-party coverage and reimbursement; the implementation of our business model and strategic plans for our business; our expectations regarding our strategic partnership with Fresenius Medical Care Holdings, Inc. to sell, market and distribute our 6 millimeter ATEV for certain specified indications and in specified markets; the performance of other third parties on which we rely, including our third-party manufacturers, our licensors, our suppliers and the organizations conducting our clinical trials; our ability to obtain and maintain intellectual property protection for our product candidates as well as our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others; our ability to maintain the confidentiality of our trade secrets, particularly with respect to our manufacturing process; our compliance with applicable laws and regulatory requirements, including FDA regulations, healthcare laws and regulations, and anti-corruption laws; our ability to attract, retain and motivate qualified personnel and to manage our growth effectively; our future financial performance and capital requirements; our ability to implement and maintain effective internal controls; and the impact of the overall global economy and increasing interest rates and inflation on our business. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. The potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, those risks and uncertainties included under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K for the year ended December 31, 2024, our quarterly report on Form 10-Q for the quarter ended September 30, 2025, each filed by Humacyte with the Securities and Exchange Commission, and in future filings made with the Securities and Exchange Commission from time to time. Any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of the date hereof. Except as required by law, we assume no obligation to update these
Nov 12, 2025
2 tm2530973d1_ex99-1.htm
Exhibit 99.1
Humacyte Announces Third Quarter 2025 Financial Results and Provides Business Update
- Total revenues of $753,000 for third quarter, and $1,571,000 for first nine months of 2025, from sales and collaborative research agreement -
- Major advances in pipeline as Humacyte moves closer to planned BLA filing in dialysis and first-in-human studies in cardiac bypass graft surgery –
– IND submitted to the FDA for the CABG indication –
- Symvess™ and pipeline programs highlighted in multiple scientific publications and presentations -
- Conference call today at 8:00 am ET -
November 12, 2025 – Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced financial results for the third quarter ended September 30, 2025, and provided a business update.
“During the third quarter of 2025 we continued to execute on our U.S. commercial launch of Symvess with sales increasing substantially, totaling $703,000 for third quarter compared to $100,000 in second quarter,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “This significant ramp-up is due to an increased number of individual hospital and healthcare system Value Analysis Committee (VAC) approvals, our recent inclusion in the U.S. Defense Logistics Agency’s Electronic Catalog (ECAT), and the tireless work of our commercial and medical teams in educating the vascular surgery community about the benefits of Symvess.”
“The launch of Symvess in the vascular trauma indication is just the first of the many planned products emerging from our proprietary bioengineering platform, and the advancement of our broader pipeline was supported by multiple events during the quarter,” continued Dr. Niklason. “The acellular tissue engineered vessel (ATEV™) is moving closer to our planned supplemental Biologics License Application (BLA) filing in dialysis access. This planned dialysis indication is supported by positive two-year results from the V007 Phase 3 trial presented last weekend at Kidney Week 2025, which is the world’s largest nephrology meeting. For coronary artery bypass grafting (CABG), we published positive results of a preclinical study evaluating our coronary tissue engineered vessel (CTEV) in non-human primates. These results support our plans to advance the CTEV into a human study in CABG in 2026. If successful, the CTEV would be the first novel conduit tested in CABG in the US in decades. Lastly, we expanded our intellectual property estate with the grant of a new U.S. patent for our bioengineered esophagus, complementing our existing intellectual property in urinary conduits and tracheas, all of which can be produced using our proprietary regenerative tissue engineering platform.”
Third Quarter 2025 and Recent Corporate Highlights
Symvess Market Launch and Expanded Clinical Results
Approval Process and Sales: There are now a total of 25 VAC approvals of the Symvess product compared to 13 as of the date of the August 2025 quarterly report. As these VAC approvals include multi-hospital networks, 92 civilian hospitals are now eligible to purchase Symvess. Furthermore, an additional 45 VAC committees are currently conducting their review processes. To date, 16 hospitals have ordered Symvess, with the majority placing re-orders.
1
·Publication of Outcomes for Patients with Hospital-Acquired Vascular Complications Treated with Symvess: A September 2025 publication in the Journal of Vascular Surgery reported that Symvess was observed to have high levels of patency, 100% limb salvage, and zero cases of conduit infection in 12 patients with hospital-acquired iatrogenic injuries or complications of vascular surgical procedures. Complications of surgery and vascular procedures, including iatrogenic injuries, planned oncological tumor resections, and steal syndrome following arteriovenous access placement, are increasingly common in modern medical care, and are reported to comprise close to 30% of patients requiring vascular injury repair.
·Long-term Results for Ukrainian Patients Published: An October 2025 publication in Oxford Academic’s Military Medicine described positive long-term results from a humanitarian program using Symvess to treat wartime vascular injuries in Ukraine. The publication, titled "Evaluating the Safety and Efficacy of Humacyte Acellular Tissue-Engineered Vessel in a Real-World Combat Setting: A Retrospective Observational Multicenter Study,” reported on 17 trauma patients with wartime extremity injuries who were treated with Symvess and were followed for up to 18 months. These wartime patients were observed to have a high patency rate of 87.1%, along with 100% limb salvage, and zero cases of conduit infection, showing the durability of Symvess in treatment of real-world combat injuries.
·New Data Comparing Symv
Aug 11, 2025
2 huma-20250811xexx991.htm
Document
Exhibit 99.1
Humacyte Announces Second Quarter 2025 Financial Results and Provides Business Update
- Total revenues of $301,000 for quarter, and $818,000 for first six months of 2025, from sales and collaborative research agreement -
- 82 civilian hospitals now have VAC approval to purchase Symvess™ -
- ECAT approval makes Symvess available to 35 Military Treatment Facilities and 160 U.S. Department of Veterans Affairs hospitals -
- Conference call today at 8:00 am ET -
DURHAM, N.C., August 11, 2025 – Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced financial results for the second quarter ended June 30, 2025, and provided a business update.
“During our second quarter of 2025, we continued to execute on our U.S. commercial launch and now have 82 civilian hospitals eligible to purchase Symvess,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “This is a substantial increase from the five hospitals that were eligible to purchase at our last quarterly update in May. This tremendous increase is due to a combination of individual hospital and healthcare system Value Analysis Committee (VAC) approvals. In addition, our recent inclusion on the Electronic Catalog (ECAT) means that approximately 190 Military Treatment Facilities and U.S. Department of Veterans Affairs (VA) hospitals are also eligible to purchase Symvess. While we encountered some headwinds during the second quarter of 2025 due to unsubstantiated attacks by detractors, we have moved forward and seen an acceleration in VAC approvals in late June and July. Indeed, our July product sales exceeded the total sales recorded during the first half of the year. We were also pleased to achieve our first commercial sale to a U.S. military treatment facility in July, and this facility has since re-ordered the Symvess product. We have great interest in improving the medical options available to healthcare professionals treating military personnel and their families and look forward to advancing our discussions with additional Department of Defense (DOD) hospitals.”
“We were also gratified to see that our V007 trial data was one of only three presentations selected for special mention by the Society of Vascular Surgery in June, and that the Society chose to highlight the strength of the results in their own announcement,” continued Dr. Niklason. “In our V007 trial, the ATEV was observed to have superior functional patency during the first year over the autologous fistula control group not only in the overall study population but in two important subgroups: women, and men with diabetes and obesity. These two groups make up more than half of the dialysis access market and are underserved by the current standard of care, representing a high unmet medical need. We look forward to publication of the results from the V007 Phase 3 clinical trial in a major peer-reviewed medical journal this year.”
Second Quarter 2025 and Recent Corporate Highlights
Symvess Market Launch
•VAC Approval Process and Sales: To date, a total of 13 VACs have approved the Symvess product. Since these VAC approvals include multi-hospital networks, 82 civilian hospitals are now eligible to purchase Symvess. Furthermore, an additional 40 VACs are currently conducting their review process. Humacyte has experienced an acceleration in VAC approvals in late June and July 2025, and July product sales of $0.3 million exceeded the sales recorded during the first half of the year. To date, 12
1
hospitals have ordered Symvess, with multiple facilities re-ordering additional product during the month of July.
•ECAT Approval: In July 2025, Symvess was granted ECAT listing approval from the U.S. Defense Logistics Agency. ECAT is an internet system that provides the DOD and other federal agencies with access to manufacturers’ and distributors’ products. The ECAT approval makes Symvess available to healthcare professionals treating military service members, veterans, and other patients receiving care at approximately 35 Military Treatment Facilities and approximately 160 VA hospitals.
•First Military Treatment Facility Sale: Following the ECAT approval, the first sale of Symvess to a U.S. Military Treatment Facility was completed in July. The facility is a state-of-the-art medical complex located on a major U.S. military base that provides healthcare to approximately 200,000 active-duty service personnel, retirees, and their family members. Subsequent to the initial shipment, the facility has re-ordered Symvess. We are in active discussions with additional DOD facilities that are expressing interest in purchasing Symvess.
ATEV in Dialysis
•V007 Phase 3 Study Results in Dialysis Highlighted at Major Vascular Surgery Conference: Results from the V007 Pivotal Phase 3 clinical trial
This page provides Humacyte Inc. Warrant (HUMAW) earnings call transcripts from SEC 8-K filings along with AI-powered predictions for post-earnings price movements. Our machine learning models analyze historical earnings data, pre-earnings price patterns, volume changes, and volatility to predict 1-day, 5-day, and 20-day returns after each earnings release.
Earnings transcripts are sourced directly from SEC EDGAR filings. Predictions are generated using gradient boosting models trained on HUMAW's historical earnings reactions. All predicted returns are shown as percentages, and predicted prices are calculated from the closing price at the time of prediction. Past performance does not guarantee future results.