Q2 2024 Humacyte Inc Earnings Call

Speaker Change: The End

Iseult McMahon: Iseult McMahon, Iseult McMahon, Iseult McMahon, Iseult McMahon, Good afternoon, ladies and gentlemen. Unwakoms for human sight. The second quarter is our content school. Currently, all participants are in listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Lauren Marek with LifeSci Advisors. Please go ahead.

Speaker Change: Good afternoon, ladies and gentlemen, and welcome to the Human Sites Second Quarter Resolve conference call. Currently, all participants are in listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time.

Speaker Change: As a reminder, this conference call is being recorded. I will now turn the call over to Lauren Marek with LifeSci Advisors. Please go ahead.

Lauren Marek: Thank you, Operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.

Lauren Marek: Thank you, Operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.

Lauren Marek: Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise forward-looking statements except as required by law. Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which, after filing, may be accessed from the Investors page of the Humacyte website.

Lauren Marek: Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.

Lauren Marek: The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise forward-looking statements except as required by law.

Lauren Marek: Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which after filing may be accessed from the investors page of the HumaSite website.

Lauren Marek: Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer, Dale Sander, Chief Financial Officer and Chief Corporate Development Officer, and Dr. Heather Prichard, Chief Operating Officer. Dr. Niklason will provide a summary of the company's progress during the quarter and recent weeks, and Dale will review the company's financial results for the quarter ended June 30, 2024. Following their prepared remarks, the management team will be available for your questions. I will now turn the call over to Dr. Niklason. Thank you, Lauren. Good morning, everyone.

Speaker Change: Joining me on today's call from HumaSite are Dr. Laura Niklason, President and Chief Executive Officer, Dale Sander, Chief Financial Officer and Chief Corporate Development Officer, and Dr. Heather Pritchard, Chief Operating Officer.

Speaker Change: Dr. Niklason will provide a summary of the company's progress during the quarter and recent weeks, and Dale will review the company's financial results for the quarter ended June 30, 2024. Following their prepared remarks, the management team will be available for your questions. I will now turn the call over to Dr. Niklason.

Laura Niklason: And thank you for joining us on our second quarter 2024 Financial Results and Business Update call. This has been a very productive time for Humacyte. Although we were surprised to learn that the FDA needs additional time to complete their review of the ATEV, BLA, and vascular trauma, the entire Humacyte team continues to engage in commercial preparation to support our planned U.S. market launch, if approved. In addition, the ATEV met its primary endpoint in the VO7 phase 3 trial in arteriovenous access for hemodialysis, and it demonstrated superiority over the current standard of

Dr. Niklason: Thank you, Lauren. Good morning everyone and thank you for joining us on our second quarter 2024 financial results and business update call. This has been a very productive time for Humacyte.

Speaker Change: Although we were surprised to learn that the FDA needs additional time to complete their review of the ATEV, BLA, and vascular trauma, the entire Humacyte team continues to engage in commercial preparation to support our planned U.S. market launch, if approved.

Speaker Change: In addition, the ATEV met its primary endpoint in the VO7 phase 3 trial in arteriovenous access for hemodialysis.

Speaker Change: and it demonstrated superiority over current standard of care. The ATEV also received its third Regenerative Medicine Advanced Therapy, or RMAT designation, from the FDA.

Speaker Change: This time, in Advanced Peripheral Artery Disease, this supports ATAV's broad applicability across multiple indications.

Speaker Change: The Biovascular Pancreas, or BVP, was featured in a variety of medical and scientific presentations, which is highlighting its significant promise in type 1 diabetes.

Speaker Change: And finally, we strengthened our board of directors with the addition of two seasoned experts, Dr. John Bamforth and Dr. Keith, or Tony, Jones.

Laura Niklason: The ATEV also received its third Regenerative Medicine Advanced Therapy, or RMAT, designation from the FDA, this time for Advanced Peripheral Artery Disease. This supports ATAV's broad applicability across multiple indications. The Biovascular Pancreas, or BVP, was featured in a variety of medical and scientific presentations, which are highlighting its significant promise in type 1 diabetes, and finally, we strengthened our Board of Directors with the addition of two seasoned experts, Dr. John Bamforth and Dr. Keith Ortoni Jones. During today's call, I'll review these developments in more detail before turning the call over to Dale for a review of our financial results, then we'll be happy to open the call to your questions.

Speaker Change: During today's call, I'll review these developments in more detail before turning the call over to Dale for a review of our financial results. Then we'll be happy to open the call up to your questions.

Laura Niklason: I'll begin with our program in vascular trauma. On Friday, we announced that the FDA will require additional time to complete its review of the BLA that we submitted for the ATEV in the vascular trauma indication. We were surprised to receive this notification from the FDACber leadership, who apologized and noted that our ATEV is a first-in-class product. As a reminder, the BLA for the ATEF trauma program was submitted to the FDA in December of 2023. The FDA granted a priority review in February 2024, which allows only a six-month review cycle instead of the standard 10 months for most products. The original assigned PDUFA date was August 10, 2024.

Speaker Change: I'll begin with our program in vascular trauma.

Speaker Change: On Friday, we announced that the FDA will require additional time to complete its review of the BLA that we submitted for the ATEV in the vascular trauma indication.

Speaker Change: We were surprised to receive this notification from the FDA CBER leadership, who apologized and noted that our ATEV is a first-in-class product.

Speaker Change: As a reminder, the BLA for the ATEF trauma program was submitted to the FDA in December of 2023.

Speaker Change: The FDA granted a priority review in February 2024, which allows only a six-month review cycle instead of the standard ten months for most products.

Speaker Change: The original assigned PDUFA date was August 10, 2024.

Laura Niklason: Despite the FDA's delay, I want to emphasize that we remain confident in the approvability of the ATEV in vascular trauma. Based on our interactions with the agency to date, during the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and our clinical sites. They've also actively engaged with us in multiple discussions regarding the BLA filing, including post-approval marketing and labeling discussions. The FDA apologized for missing the August 10th PDUFA date, and we do not yet have a revised action date, as we await an updated action date from the FDA. Meanwhile, we continue to prepare for a planned U.S. launch, as we discussed last quarter. We've implemented a company-wide multidisciplinary program designed to ensure U.S. launch readiness.

Speaker Change: Despite the FDA's delay, I want to emphasize that we remain confident in the approvability of the ATEV in vascular trauma. Based on our interactions with the agency to date,

Speaker Change: During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and our clinical sites.

Speaker Change: They've also actively engaged with us in multiple discussions regarding the BLA filing, including post-approval marketing and labeling discussions.

Speaker Change: The FDA apologized for missing the August 10th PDUFA date, and we do not yet have a revised action date.

Speaker Change: As we await an updated action date from the FDA,

Speaker Change: Humacyte continues to prepare for a planned U.S. launch.

Speaker Change: As we discussed last quarter, we've implemented a company-wide, multidisciplinary program designed to ensure U.S. launch readiness. In June, we announced issuance of four new ICD-10 codes from the Centers for Medicare and Medicaid Services, or CMS.

Laura Niklason: In June, we announced the issuance of four new ICD-10 codes from the Centers for Medicare and Medicaid Services, or CMS. These codes will be effective for hospital discharges beginning in October 2024 and will cover procedures for replacing arteries in the upper or lower extremities using the A-tests. Humacyte also previously announced that we've hired Morgan Rankin as Vice President of Sales, joining Humacyte after 12 years at Teleflex Medical. Morgan most recently served as Vice President of Sales for trauma and emergency medicine at Teleflex, where she led a team of approximately 100 sales professionals.

Speaker Change: These codes will be effective for hospital discharges beginning in October 2024 and will cover procedures for replacing arteries in the upper or lower extremities using the ATEV.

Speaker Change: Humacyte also previously announced that we've hired Morgan Rankin as Vice President of Sales, joining Humacyte after 12 years at Teleflex Medical.

Morgan Rankin: Morgan most recently served as VP of sales trauma and emergency medicine at Teleflex where she led a team of approximately 100 sales professionals.

Laura Niklason: Our entire commercialization team is positioning Humacyte to be ready for commercial launch of the ATEV in vascular trauma upon approval by the FDA in the future. Now, to our program in Dialysis Access. In July of 2024, we were incredibly pleased to announce positive results from the VO7 Phase 3 trial of the ATEV for arteriovenous access in hemodialysis patients who have end-stage renal disease. As a reminder, this trial enrolled 242 patients and is a prospective, multi-center, randomized study designed to evaluate the usability of the ATAB for dialysis during the first 12 months after implantation.

Morgan Rankin: Our entire commercialization team is positioning Humacyte to be ready for commercial launch of the ATEV in vascular trauma upon approval by the FDA in the future.

Laura Niklason: All participants will continue to be followed for a total of 24 months after implantation. The primary endpoint assessed functional patency or usability for dialysis access at six months, as well as secondary patency or blood flow through the conduit at twelve months. These assessments were co-primary endpoints and were compared to arteriovenous fistula, which is the current standard of care in dialysis accidents. At six months, 81% of patients implanted with the ATEV had functional patency as compared to 66% of patients receiving a fistula.

Laura Niklason: At 12 months, 68% of patients implanted with the ATEV had secondary patency, or blood flow through the conduit, as compared to 62% of patients receiving an AV fistula. The joint test for superiority of the ATEV versus the AV fistula at 6 and 12 months was statistically significant.

Morgan Rankin: Turning now to our program in dialysis access, in July of 2024 we were incredibly pleased to announce positive results from the VO7 phase 3 trial of the ATEV for arteriovenous access in hemodialysis patients who have end-stage renal disease.

Laura Niklason: Patients who received the A-TEV also utilized the conduit significantly longer for hemodialysis during the first 12 months as compared to Fichula. There were more adverse events reported in patients on the ATEF treatment arm than in those in the dialysis fistula treatment arm, although the impact of this observation is not clear at this time. We're highly encouraged by these results, and we believe that they demonstrate the potential of the ATEV to improve arteriovenous access in hemodialysis patients who are underserved by the current standard of care.

Morgan Rankin: As a reminder, this trial enrolled 242 patients and is a prospective, multi-center, randomized study designed to evaluate the usability of the ATAB for dialysis during the first 12 months after implantation.

Morgan Rankin: All participants will continue to be followed for a total of 24 months after implantation.

Morgan Rankin: The primary endpoint assessed functional patency, or usability for dialysis access, at 6 months, as well as secondary patency, or blood flow through the conduit, at 12 months.

Morgan Rankin: These assessments were co-primary endpoints and were compared to arteriovenous fistula, which is the current standard of care in dialysis access.

Morgan Rankin: At six months, 81% of patients implanted with the ATEV

Morgan Rankin: had functional patency as compared to 66% of patients receiving a fistula.

Morgan Rankin: At 12 months, 68% of patients implanted with the ATEV had secondary patency, or blood flow through the conduit, as compared to 62% of patients receiving an AV fistula.

Morgan Rankin: The joint test for superiority of the ATEV versus AV fistula at 6 and 12 months was statistically significant.

Morgan Rankin: Patients who receive the ATEV also utilize the conduit significantly longer for hemodialysis during the first 12 months as compared to fistula.

Morgan Rankin: There were more adverse events reported in patients on the ATEF treatment arm than on those in the dialysis fistula treatment arm, although the impact of this observation is not clear currently.

Speaker Change: were highly encouraged by these results, and we believe that they demonstrate the potential of the ATAV

Speaker Change: to improve arteriovenous access in hemodialysis patients who are underserved by the current standard of care. We look forward to presenting more detailed clinical results, including subgroup analyses, at upcoming medical meetings.

Laura Niklason: We look forward to presenting more detailed clinical results, including subgroup analyses, at upcoming medical meetings. We're also making progress in our program in Advanced Peripheral Arterial Disease, or PAD. PED is a cardiovascular disease of blood vessels, most commonly affecting arteries in the lower leg. As many as 40% of patients who require a bypass to repair arteries of the lower leg do not have an autologous vein available for revascular

Speaker Change: Thank you for watching, see you in the next video!

Speaker Change: We're also making progress in our program in Advanced Peripheral Arterial Disease or PAD.

Speaker Change: PAD is a cardiovascular disease of blood vessels, most commonly affecting arteries in the legs.

Speaker Change: As many as 40% of patients who require a bypass to repair arteries of the lower leg do not have an autologous vein available for revascularization. Autologous vein is the standard of care for such patients.

Laura Niklason: Autologous vein is the standard of care for such patients. In June of 2024, Dr. Todd Rasmussen and colleagues at the Mayo Clinic in Rochester, Minnesota published the outcomes of arterial bypass using the ATEV in patients with chronic limb ischemia or severe PAD. In this paper, which appeared in the Journal of Vascular Surgery, all patients treated with the ATEV for severe PAD had no suitable vein of their own for bypass, and were treated under an investigator-sponsored trial.

Laura Niklason: Outcomes for ATEV patency or blood flow and limb salvage in patients with severe PAD having no veins were comparable to historical control patients having similar disease but having received a bypass using their own vein at the Mayo Clinic.

Speaker Change: In June of 2024, Dr. Todd Rasmussen and colleagues at the Mayo Clinic in Rochester, Minnesota published the outcomes of arterial bypass using the ATEV in patients with chronic limb ischemia or severe PAD.

Speaker Change: In this paper, which appeared in the Journal of Vascular Surgery, all patients treated with the ATEV for severe PAD had no suitable vein of their own for bypass and were treated under an investigator-sponsored trial.

Speaker Change: Outcomes for the ATEV patency or blood flow and limb salvage in patients with severe PAD having no vein were comparable to historical control patients having similar disease but having received a bypass using their own vein at the Mayo Clinic.

Laura Niklason: Mayo Investigators reported that patency and limb salvage were similar for patients receiving Atev and patients receiving bypass with their own vein history. This result highlights the potential impact that Humacyte's ATAV may have on patients suffering from severe PD and having no vein of their own to perform a bypass operation. In July, the FDA also granted an RMAT designation for the ATAV in the PAD indication. Following vascular trauma, AV access, and hemodialysis, this marks the third indication for which the ATEV has been granted this RMAT designation.

Speaker Change: Mayo investigators reported that patency and limb salvage were similar for patients receiving ATEV and patients receiving bypass with their own vein historically.

Speaker Change: This result highlights the potential impact that humicides ATEV may have on patients suffering from severe PAD and having no vein of their own to perform a bypass operation.

Speaker Change: In July, the FDA also granted an RMAT designation for the ATAV in the PAD indication.

Speaker Change: Following vascular trauma and AV access and hemodialysis, this marks the third indication for which the ATEV has been granted this RMAT designation.

Laura Niklason: This designation is designed to provide pathways for expedited development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. This designation allows for close interactions with the FDA and potentially an expedited or priority review of any BLA. At the same time, we also received clearance for a newly issued IND for the ATV in the PAD indication. To date, the ATEV has been evaluated in two Phase II trials in PAD, with patients followed for as long as six years.

Speaker Change: This designation is designed to provide pathways for expedited development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions.

Speaker Change: This designation allows for close interactions with the FDA and potentially an expedited or priority review of any BLA. At the same time, we also receive clearance for a newly issued IND for the ATEV in the PAD indication.

Speaker Change: To date, the ATEV has been evaluated in two Phase II trials in PAD, with patients followed for as long as six years.

Laura Niklason: In addition, an ongoing study at the Mayo Clinic is evaluating the ATEV in 30 patients with chronic limb-threatening ischemia. All patients treated with the A-TEV and PAD to date have had no autologous vein available for revascularization.

Speaker Change: In addition, the ongoing study at the Mayo Clinic is evaluating the ATEVs in 30 patients with chronic limb-threatening ischemia.

Speaker Change: All patients treated with the ATEV and PAD to date have had no autologous vein available for revascularization and we believe the ATEV may represent an important therapeutic alternative for these patients.

Laura Niklason: And we believe the ATAB may represent an important therapeutic alternative for these patients. Returning now to diabetes, results from an ongoing preclinical study of our biovascular pancreas or BVP product candidate continued to be featured in medical meetings. The BVP is designed to enable the delivery and survival of insulin-producing islets as a potential treatment for type 1 diabetes. At the Breakthrough T1D Beta Cell Consortium meeting in June, scientists presented data in which stem cell derived islets were observed to restore normal blood sugar in diabetic mice. In the mice, the stem cell islets survived and continued to produce insulin with no evidence of adverse events from the stem cell derived islets.

Laura Niklason: These experiments were performed in collaboration with the Diabetes Research Institute at the University of Miami. In addition, we also presented results from a non-human primate study at the American Diabetes Association Annual Meeting in June. In this study, primate BVP implants showed eyelid survival and continued insulin production throughout the three-month duration of the study. The eyelids also developed capillaries to support survival of the insulin-producing cells.

Speaker Change: Thank you for watching!

Speaker Change: Returning now to diabetes, results from an ongoing preclinical study of our biovascular pancreas or BVP product candidate continue to be featured in medical meetings.

Speaker Change: The BVP is designed to enable the delivery and survival of insulin-producing islets as a potential treatment for type 1 diabetes.

Speaker Change: at the Breakthrough T1D Beta Cell Consortium meeting in June.

Speaker Change: scientists presented data in which stem cell derived islets were observed to restore normal blood sugar in diabetic mice.

Speaker Change: In the mice, the stem cell islets survived and continued to produce insulin, with no evidence of adverse events from the stem cell-derived islets.

Speaker Change: These experiments were performed in collaboration with the Diabetes Research Institute at the University of Miami.

Speaker Change: In addition, we also presented results from a non-human primate study at the American Diabetes Association annual meeting in June. In this study, primate BVP implants showed islet survival and continued insulin production throughout the three-month duration of the study.

Speaker Change: Eyelids also developed capillaries to support survival of the insulin-producing cells. This study was also performed in collaboration with the Diabetes Research Institute.

Laura Niklason: This study was also performed in collaboration with the diabetes researcher. We also presented results from studies of our small caliber, 3.5mm diameter ATAV in the coronary artery bypass grafting or caesarean setting. We also presented results from studies of our small caliber, 3.5mm diameter ATAV in the coronary. This presentation was at the Tissue Engineering and Regenerative Medicine Conference in June. Preclinical six-month studies have been conducted in non-human primates to support the planned advancement of the small-diameter ATEV into Phase I human clinical trials in CABIT. We have observed remodeling of the ATAV to a diameter that closely matches that of the native coronary vessel, which is an outcome that has not been observed with any other conduit previously.

Speaker Change: We also presented results from studies of our small-caliber, 3.5-millimeter diameter ATAV in the coronary artery bypass grafting or CABG setting. This presentation was at the Tissue Engineering and Regenerative Medicine Conference in June.

Speaker Change: Preclinical six-month studies have been conducted in non-human primates to support the planned advancement of the small-diameter ATEV into Phase I human clinical trials in cabbage.

Speaker Change: We have observed remodeling of the ATEV to a diameter that closely matches that of the native coronary vessels, which is an outcome that has not been observed with any other conduit previously.

Dale Sander: This finding demonstrates the favorable biologic response of the host to the engineered human arteries in the coronary system. We are very pleased that the preclinical studies of the BVP and small diameter ATV continued to show promising results and will continue to update on the progress of this and other pipeline programs as they advance. Finally, last quarter, we welcomed pharmaceutical industry veteran, Dr. John P. Bamforth, and the distinguished health system leader and physician, Dr. Tony Jones, to the company's board of directors.

Speaker Change: This finding demonstrates the favorable biologic response of the host to the engineered human arteries in the coronary system.

Speaker Change: We're very pleased that the preclinical studies of the BVP and small diameter ATEV continue to show promising results, and we'll continue to update on the progress of this and other pipeline programs as they advance.

Speaker Change: Finally, last quarter we welcomed

Speaker Change: and the distinguished health system leader and physician, Dr. Tony Jones, to the company's board of directors.

Dale Sander: John and Tony are both distinguished commercialization and health system leaders whose experience and perspectives will be extremely valuable as we prepare for the planned commercial launch of the ATEV in vascular trauma. And with that, I'll now turn it over to Dale for a review of our financial results and other business developments. Thank you, Laura. Now turning to the financial report that came out this morning, there were no revenues in any of the quarters or six-month periods reported today.

Speaker Change: John and Tony are both distinguished commercialization and health system leaders whose experience and perspectives will be extremely valuable as we prepare for planned commercial launch of the ATEV in vascular trauma.

Dale Sander: Revenant, sorry, research and development expenses were 23.8 million for the second quarter of 2024, compared to 20.5 million for the second quarter of 2023, and we're 45.0 million for the six months ending June 30, 2024, compared to 37.8 million for the six months ended June 30, 2023. The current priority increases resulted primarily from increased materials and personnel expenses. The current priority increases for the second quarter of 2020 resulted mainly from increased materials and personnel expenses to support expanded research and development initiatives, primarily in the areas of expanding our manufacturing activities and in support of the FDA review of the BLA and vascular trauma.

Speaker Change: And with that, I'll now turn it over to Dale for a review of our financial results and other business developments.

Dale Sander: General and administrative expenses were $5.7 million for the second quarter of 2024 compared to $6.2 million for the second quarter of 2023, and we're 11.1 million for the six months ending June 30, 2024, compared to 11.4 million for the six months ended June 30, 2023. The decreases during 2024 resulted primarily from decreased non-cash stock compensation expense, partially offset by increased personnel expenses and increased professional fees.

Dale: Thank you, Laura.

Dale: Now turning to the financial report that came out this morning. There were no revenues in any of the quarters or six-month periods reported today.

Dale: revenue, sorry, research and development expenses were $23.8 million for the second quarter of 2024 compared to $20.5 million for the second quarter of 2023.

Dale: and were $45.0 million for the six months into June 30, 2024 compared to $37.8 million for the six months into June 30, 2023. The current period increases resulted primarily from increased materials and personnel expenses

Dale: to support expanded research and development initiatives.

Dale: primarily in the areas of expanding our manufacturing activities and in support of the FDA review of the BLA and vascular trauma.

Dale: General and administrative expenses were $5.7 million for the second quarter of 2024, compared to $6.2 million for the second quarter of 2023.

Dale: and were $11.1 million for the six months ended June 30, 2024, compared to $11.4 million for the six months ended June 30, 2023.

Dale: The decreases during 2024 resulted primarily from decreased non-cash stock compensation expense.

Dale: partially offset by increased personnel expenses and increased professional fees.

Dale Sander: Other net income or expense was a net expense of $27.2 million for the second quarter of 2024, compared to an income of $4.0 million for the second quarter of 2023. For the six months ended June 30, 2024, other net expense was $32.5 million compared to $10.4 million for the six months ended June 30, 2023. The increase in other net expense for the second quarter of 2024 and for the six months into June 30, 2024, compared to 2023, resulted primarily from the non-cash remeasurement of the contingent earn out liability associated with the company's August 2021 merger with Alpha Healthcare Acquisition Corp. Net loss was $56.7 million for the second quarter of 2024, compared to $22.7 million for the second quarter of 2023. The net loss was $88.6 million for the six months ending June 30.

Dale: Other net income or expense was net expense of $27.2 million for the second quarter of 2024 compared to net income of $4.0 million for the second quarter of 2023.

Dale: For the six months ended June 30, 2024, other net expense was $32.5 million compared to other net expense of $10.4 million for the six months ended June 30, 2023.

Dale: the increase in other net expense for the second quarter of 2024 and for the six months into June 30, 2024 compared to 2023.

Dale: resulted primarily from the non-cache re-measurement.

Dale: of the contingent are now liability.

Dale: associated with the company's August 2021 merger with Alpha Healthcare Acquisition Corp.

Dale: Net loss was $56.7 million for the second quarter of 2024, compared to $22.7 million for the second quarter of 2023.

Laura Niklason: 2024, compared to $59.7 million for the six months ended June 30, 2023. The current period increase in net loss resulted primarily from the non-cash remeasurement of the contingent earn out liability and net operating expense increases described previously. The company reported cash and cash equivalents of 93.6 million as of June 30, 2024. Total net cash provided was $13.1 million for the first six months of 2024 compared to net cash used of $35.2 million for the first six months of 2023.

Dale: Net loss was $88.6 million for the six months ended June 30, 2024 compared to $59.7 million for the six months ended June 30, 2023.

Dale: The current period increase in net loss resulted primarily from the non-cash re-measurement of the contingent earn-out liability.

Dale: and net operating expense increases described previously.

Dale: The company reported cash and cash equivalents of $93.6 million as of June 30, 2024.

Dale: Total net cash provided was $13.1 million for the first six months of 2024 compared to net cash used of $35.2 million for the first six months of 2023.

Laura Niklason: The increase in net cash provided resulted primarily from the receipt of approximately $43 million in net proceeds from an underwritten public offering of common stock in March 2024, and $20 million in proceeds from an additional draw under our funding arrangement with Oberlin Capital Management. With that, I'd like to turn it back to Laura for some concluding remarks. Thank you, Dale. We're very excited about the future of Humacyte.

Dale: The increase in net cash provided resulted primarily from the receipt of approximately $43 million in net proceeds from an underwritten public offering of common stock in March 2024.

Dale: and 20 million in proceeds from an additional draw under our funding arrangement with Oberlin Capital Management.

Dale: With that, I'd like to turn it back to Laura for some concluding remarks.

Laura Niklason: We're confident that the FDA approval of the ATAV in vascular trauma is coming soon, and we and our entire organization are continuing to prepare for commercialization of our first product, if approved. We also remain committed to advancing our pipeline program, which continues to demonstrate encouraging results and underscore the promise of ATEV across a wide range of diseases, injuries, and chronic conditions. This is a transformational period for us, and we're grateful for your continued support. Thank you for joining us on the call today.

Laura: Thank you, Dale. We're very excited about the future of human sight.

Speaker Change: We're confident that the FDA approval of the ATEV in vascular trauma is coming soon and we and we and our entire organization are continuing to prepare for commercialization of our first product if approved.

Speaker Change: We also remain committed to advancing our pipeline programs, which continue to demonstrate encouraging results and underscore the promise of the ATEV across a wide range of diseases, injuries, and chronic conditions.

Speaker Change: This is a transformational period for us, and we're grateful for your continued support.

Operator: Operator, we're ready to take questions. Thank you. Ladies and gentlemen, at this time we will be conducting a question and answer session. If you would like to ask a question, please first start then one on your telephone, keep out! [inaudible] A confirmation tone will indicate your line is in the question queue. You may press star and then 2 if you would like to remove your question from the queue.

Speaker Change: Thank you for joining us on the call today. Operator, we're ready to take questions.

Speaker Change: Thank you so much for watching this video.

Speaker Change: Thank you. Ladies and gentlemen, at this time we will be conducting a question and answer session.

Speaker Change: If you would like to ask a question, please press star then 1 on your telephone keypad.

Speaker Change: A confirmation tone will indicate your line is in the question queue.

Speaker Change: You may press star and then 2 if you would like to remove your question from the queue.

Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Again, if you would like to ask a question, please press star and then 1 now.

Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Again, if you would like to ask a question, please press star and then 1 now. The first question that he has comes from Ryan Zimmerman of BTIG. Please go ahead. Good morning.

Speaker Change: The first question that we have comes from Ryan Zimmerman of BTIG. Please go ahead. Good morning. Thanks for taking our questions, Laura and Dale.

Ryan Zimmerman: Thanks for taking our questions, Laura and Dale. And you know, apologies for this myopic focus here on vascular trauma, but just a couple questions for me. If the FDA does communicate with you, I guess I'm curious, you know, what they should expect a new date for a clearance, or will it simply provide a clearance at a future date as you understand it today. And then, you know, as part of that, what impact does this have on your BLA submission timing for AV access, which I think is expected later this year, and I've won follow-up. So Ryan, this is Laura Niklason.

Ryan Zimmerman: And, you know, apologies for this myopic focus here on vascular trauma, but just a couple questions for me. First,

Ryan Zimmerman: If the FDA does communicate with you, I guess I'm curious, you know, should we expect a new date?

Speaker Change: for clearance, or will it simply provide a clearance at a future date as you understand it today?

Speaker Change: And then, you know, as part of that, what impact does this have on your BLA submission timing for AV access, which I think is expected later this year. And then I have one follow-up. Thank you.

Laura Niklason: Thanks for that question. As far as what to expect as far as a new PDUFA date or timing on a decision, I wish I could provide more clarity for this group, but I can't. You know, again, the phone call from the senior leadership at CBER on Friday said simply that they needed more time, and they did not give us any insight into a new date or how we would be informed. That said, I would expect that within the next several months we will hear a decision, but the exact mechanics of that are very hard for me to predict. I just can't at this stage.

Laura Niklason: So, Ryan, this is Laura Niklason. Thanks for that question. As far as what to expect as far as a new PDUFA date or timing on a decision, I wish I could provide more clarity for this group, but I can't. You know, again, the phone call from the senior leadership at...

Speaker Change: at CBER on Friday said simply that they need more time and they did not give us

Speaker Change: insight into a new date or how we would be informed.

Speaker Change: That said, I would expect that within the next several months, we will hear a decision, but the exact mechanics of that is very hard for me to predict. I just can't at this stage.

Laura Niklason: With respect to the supplemental BLA that we had been planning and hoping to file for dialysis access, from my standpoint, that's still on track. You know, the reality is that, you know, we just got top-line results in our phase three trial a couple weeks ago, and we're still processing those results. Our plan was

Speaker Change: With respect to the supplemental BLA that we had been planning and hoping to file in dialysis access, from my standpoint, that's still on track.

Speaker Change: You know, the reality is that, you know, we just got top-line results in our Phase 3 trial a couple weeks ago. We're still processing those results. Our plan had been.

Laura Niklason: Assuming FDA approval in trauma in the second half of this year, our plan had been to initiate commercial launch and then look at filing a supplemental BLA perhaps sometime in 2025. So I don't think we've messaged the market that we were going to file a supplemental BLA in late 2014. So, you know, from my standpoint, barring any other changes in timing from the FDA, the communicated timing on BLA filing for dialysis kind of remains the same.

Speaker Change: assuming FDA approval in trauma in the second half of this year.

Speaker Change: Our plan had been to initiate commercial launch and then look at filing a supplemental BLA, perhaps sometime in 2025. So, I don't think we've messaged the market that we were going to file a supplemental BLA in late 24.

Speaker Change: So, you know, from my standpoint, you know, barring any other changes in timing from the FDA.

Speaker Change: The communicated timing on BLA filing for dialysis kind of remains the same, you know, depending on conversations with the FDA. We would hope to file sometime in 2025. So that remains on track as near as I can tell.

Laura Niklason: You know, depending on conversations with the FDA, we would hope to file sometime in 2025. So that remains on track as near as I can tell, very helpful. And then for Dale, you know, how do you think about operating expenses? Cash Burn, Yeah, Ryan, I think the... to extrapolate from what Laura said, we don't know what the delay will be at this instant.

Dale: Okay, very helpful and then for Dale

Dale: You know, how do you think about operating expenses and cash burn during this interim period? Just given the delay impact, are you, you know,

Dale: pulling back anything? Are you, you know, full steam ahead, foot on the gas? Help us understand kind of how you're managing your cash in this kind of limbo period that you're in right now as a result of Friday's update.

Dale: Yeah, Ryan, I think the...

Speaker Change: to extrapolate from what Laura said, you know, we don't know what the delay will be at this instance.

Dale Sander: But the entire BLA process has been one that's been very iterative, and so our expectation is that as these weeks unfold, we're going to have a better sense of what that timeline is. Based on our assessment of the timeline to completing this process, we will, you know, apply that knowledge and be prudent in terms of how we undertake new programs and how we manage operating expenses. I think, you know, being essentially two working days out from the notice from the FDA, there's limits to what we know right now.

Speaker Change: But the entire BLA process has been one that's been very iterative. And so our expectation is that as these weeks unfold, we're going to have a better sense of what that timeline is. Based on our assessment of timeline to completing this process,

Speaker Change: then we will apply that knowledge and be prudent in terms of how we undertake new programs and how we manage.

Speaker Change: operating expenses.

Speaker Change: I think, you know, being essentially...

Dale Sander: We're certainly thinking about how we're going to respond to different potential outcomes in terms of what that timeline is. But it's a little early to give specifics in terms of how we might change our operations under different scenarios of timelines, but clearly, we're looking at it very closely.

Speaker Change: Two working days out from the notice from the FDA. There's limits to what we know right now. We're certainly thinking about how we're going to respond to different potential outcomes in terms of what that timeline is, but it's a little early to give specifics in terms of.

Speaker Change: how we might change our operations under different scenarios of timelines, but clearly we're looking at it very closely.

Ryan Zimmerman: Thank you for taking the questions. Thank you. The next question we have comes from Josh Jennings of T.D. Cohen and Company. Please go ahead. Hi, good morning.

Speaker Change: Understood. Thank you for taking the questions.

Speaker Change: Thank you.

Speaker Change: The next question we have comes from Josh Jennings of T.D. Cohen and Company. Please go ahead.

Joshua Jennings: Thanks for taking the questions, Laura and Dale. I wanted to just ask about the vascular trauma dataset and just, you know, to call out that adverse events were higher in the ATEV study group. I don't think that you're disclosing much around that, but the efficacy was not impacted. Our assumption is that these are minor adverse events in total, but just wanted to see if there's any other color you can share on that.

Josh Jennings: Hi, good morning. Thanks for taking the questions Laura and Dale. I wanted to just ask about the vascular trauma dataset and just you know to call out that

Josh Jennings: that adverse events were higher in the ATEV study group.

Speaker Change: I don't think that you're disclosing much around that, but the efficacy was not impacted. Our assumption that these are minor adverse events in total, but just wanted to see if there's any other color you can share.

Joshua Jennings: Sure. Yeah, Josh, just to clarify, that was on dialysis. That's not on trauma. Thank you. Sorry about that. I appreciate it. Yeah, yeah, yeah. I just don't want our listeners to think that was on trauma.

Speaker Change: on measure. Yeah so Josh just just to clarify that was on dialysis that's not on trauma.

Speaker Change: Thank you. Sorry about that. I appreciate it. Yeah, yeah, yeah, yeah. I just don't want our listeners to think that was on trauma. Yeah, so on dialysis.

Laura Niklason: Yeah, so on dialysis, yeah, we're still digging into that. You know, most of these adverse events are minor. As you know, in dialysis access, these patients undergo a lot of procedures in general to maintain access patency. It's just how life is for these patients. I will say very clearly that we have no new safety signals for this conduit. None.

Speaker Change: Yeah, we're still digging into that. You know, most of these adverse events are minor, as you know. In dialysis access, you know, these patients undergo a lot of procedures in general to maintain access patency. It's just how life is for these patients.

Operator: Currently, all participants are in listen only mode.

Operator: Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded.

Laura Niklason: It's not like we've seen anything new that we haven't seen before. So the increased number of adverse events, I'm not sure. It could be related to the fact that our vessels were used for a longer period of time during the first year and got more needle punctures or something else. So it's hard for me to comment on that right now. But we're in the process of sorting that out, and we expect to share this information at medical meetings later this year. And the second one on the AV access indication and the top-line data: just how involved is Fresenius in terms of aggregating the data? How much have they seen?

Speaker Change: I will say very clearly

Lauren Marek: I will now turn the call over to Lauren Marek with my side-visors. Please go ahead. Thank you, operator.

Speaker Change: that we have no new safety signals for this conduit, none.

Speaker Change: It's not like we've seen something new that we haven't seen before.

Speaker: Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under US Federal Security's laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as the date hereof, and the company undertakes no obligation to update or revise forward-looking statements except as required by law.

Speaker Change: So the increased number of adverse events, I'm not sure, it could be related to the fact that our vessels were used for a longer period of time during the first year and got more needle punctures.

Speaker Change: or something else. So it's hard for me to comment on right now, but we're in the process of sorting that out and we expect to share this information at medical meetings later this year.

Speaker Change: Understood. And the second one on the APAV access.

Speaker Change: indication

Speaker Change: and the top-line data, and how involved is Fresenius in terms of aggregating the data? How much have they seen? And I guess, what's next steps in terms of that agreement and collaboration on two fronts? One, just continued collection of cost-effectiveness data.

Speaker: Information presented on this call is contained in the press release we issued this morning, and in our form 10Q, which after filing may be accessed from the investor's page of the Humocyte website.

Laura Niklason: And I guess what the next steps in terms of that agreement and collaboration on two fronts are? One, just continued collection of cost-effectiveness data. And then two, I think down the line, Fresenius has agreed to use ATEV in any indication where clinical value has been demonstrated. Well, certainly we've worked with a number of renal care centers, dialysis access centers, as part of the VO7 Phase III trial. That said, pricenius is not active in aggregating or analyzing our data.

Speaker: Joining me on today's call from Humocyte are Dr. Laura Nicholson, President and Chief Executive Officer, Dale Sander, Chief Financial Officer and Chief Corporate Development Officer, and Dr. Heather Pritchard, Chief Operating Officer. Dr. Nicholson will provide a summary of the company's progress during the quarter and recent weeks, and Dale will review the company's financial results for the quarter-ended June 30, 2024. Following their prepared remarks, the management team will be available for your questions.

Speaker Change: And then two, I think down the line, Presenius has agreed to use ATEV in any indication where clinical value has been demonstrated.

Speaker Change: Well, so certainly we've worked with a number of Fresenius centers, dialysis access centers, as part of the VO7 phase 3 trial. That said, Fresenius is not active in aggregating or analyzing our data. You know, that's a human site endeavor for sure.

Laura Niklason: I will now turn the call over to Dr. Nicholson. Thank you, Lauren. Good morning, everyone, and thank you for joining us on our second quarter, 2024 Financial Results and Business Update Call. This has been a very productive time for Humocyte, although we were surprised to learn that the FDA needs additional time to complete their review of the ATAV BLA and Vascular Trauma. The entire Humocyte team continues to engage in commercial preparation to support our planned U.S, market launch, if approved.

Laura Niklason: You know, that's a noble endeavor for sure. But as you mentioned, our partnership with them really does focus on health economics and the cost-benefit analysis for different demographics of dialysis patients. So we are working closely with Fresenius on actually putting together a publication on some of the costs that are incurred by patients who have multiple access failures and what that costs the system, and we're also working with them on a similar project in Europe. So they've been great partners for that.

Speaker Change: But, as you mentioned, you know, our partnership with them really does focus on the health economics and the cost-benefit analysis for different demographics of dialysis patients.

Speaker Change: So we are working closely with Fresenius actually on putting together a publication on some of the costs that are incurred with patients who have multiple access failures and what that costs the system.

Laura Niklason: In addition, the ATAV met its primary endpoint in the VO7 Phase III trial in arteriovenous access for human dialysis, and it demonstrated superiority over current standard of care. The ATAV also received its Third Regenerative Medicine Advanced Therapy, or ARMAT designation, from the FDA. This time, in advanced peripheral artery disease, this supports ATAV's broad applicability across multiple indications. The Biovascular Pancreas, or BVP, was featured in a variety of medical and scientific presentations, which is highlighting its significant promise in Type 1 Diabetes, and finally, we strengthened our Board of Directors with the addition of two seasoned experts, Dr. John Bambforth and Dr. Keith Ortoni Jones. During today's call, I'll review these developments in more detail before turning the call over to Dale for a review of our financial results.

Speaker Change: and we're also working with them on a similar project in Europe. So they've been great partners for that. And you're right.

Laura Niklason: And you're right. Forsenius, you know, as part of our commercialization agreement, they have agreed to adopt Atev in dialysis for their centers in patients where the clinical results and the health economic results make sense. So, working with them to identify those patient populations where the health economics become really prohibitive for dialysis access, that's a key part of our long-term market adoption strategy in the U.S., and they're working with us very closely on that.

Speaker Change: Fresenius, you know, as part of our commercialization agreement, they have they have agreed to adopt the ATEV in dialysis.

Speaker Change: for their centers in patients where the clinical results and the health economic results make sense. So working with them to identify those patient populations which where the health economics become really prohibitive for dialysis access.

Speaker Change: That's a key part of our long-term market adoption strategy in the U.S. and they're working with us very closely on that.

Laura Niklason: Great, just one more to sneak in just on the PAD indication, and you know you've had some positive updates and RMAT designation. Just wanted to, I'm not sure if you did this earlier in the call, and you prepared Mark's slide, but just any next steps, outline you can provide in terms of moving forward with the initiation of a clinical trial and getting that up and running. Thanks a lot.

Speaker Change: Great, just one one more to sneak in just on the PAD indication and you know you've had some some positive updates and RMAT designation.

Speaker: Then we'll be happy to open the call up to your questions.

Speaker Change: Just wanted to, I'm not sure if you did this earlier in the call, and you're prepared, Mark, but just any any next steps, outline you can provide in terms of moving forward with with initiation of a clinical trial and getting that up and running. Thanks a lot.

Laura Niklason: I'll begin with our program in vascular trauma. On Friday, we announced that the FDA will require additional time to complete its review of the BLA that we submitted for the ATAV in the vascular trauma indication. We were surprised to receive this notification from the FDA-CBRA leadership, who apologized and noted that our ATAV is a first-in-class product. As a reminder, the BLA for the ATAV trauma program was submitted to the FDA in December of 2023.

Laura Niklason: Yes, well, as I may have mentioned on prior calls, we've certainly had multiple requests from vascular surgeons to initiate a phase three trial in PAD. I think there's a lot of excitement on the clinical vascular surgery side for looking at this as an option for patients who are facing potential amputation. And we are, you know, designing that trial, so we're doing the intellectual work around that. But, you know, I think that we're going to have to play it by ear in terms of the timing of the approval and the trauma and our cash runway.

Mark: Yes, well as I may have mentioned on prior calls, we've certainly had had multiple requests from vascular surgeons to initiate a phase 3 trial in PAD. I think there's a lot of excitement on the clinical vascular surgery side for looking at this as an option for patients who are facing potential amputation.

Laura Niklason: The FDA granted a priority review in February 2024, which allows only a six-month review cycle, instead of the standard ten months for most products. The original assigned pedophadate was August 10, 2024. Despite the FDA's delay, I want to emphasize that we remain confident in the approvability of the ATAV in vascular trauma, based on our interactions with the agency to date. During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and our clinical sites.

Mark: And we are, you know, designing that trial, so we're doing the intellectual work around that.

Mark: But, you know, I think that we're going to have to play it by ear in terms of the timing of the approval and trauma.

Laura Niklason: You know, again, we remain a pre-revenue company, and so we'll just have to be holistic and mindful as we think about when to start a phase three trial in PAD, given that that would be a third phase three program, so, you know, after trauma and dialysis. So it's something that we're thinking about very actively, but, as Dale said, with respect to our finances and our cash runway, you know, we're evaluating this, you know, month over month. understood. Thanks a lot.

Mark: and our cash runway. Again, we remain a pre-revenue company, and so we'll just have to be holistic and mindful as we think about when to start a Phase III trial in PAD, given that that would be a third Phase III program.

Dale: you know, after trauma and dialysis. So it's something that we're thinking about very actively, but as Dale said, with respect to our finances and our cash runway, you know, we're evaluating this, you know, month over month.

Laura Niklason: They've also actively engaged with us in multiple discussions regarding the BLA filing, including post-approval marketing and labeling discussions. The FDA apologized for missing the August 10th pedophadate, and we do not yet have a revised action date. As we await an updated action date from the FDA, Kiyuma site continues to prepare for a planned U.S, launch. As we discuss last quarter, we've implemented a company-wide multi-disciplinary program designed to ensure U.S, launch readiness.

Speaker Change: Understood. Thanks a lot.

Allison Bratzel: Thank you. The next question we have comes from Allison Bratzel of Piper Sandler. Please go ahead. Hey, thanks.

Speaker Change: Thank you. The next question we have comes from Alison Brassell of Piper Sandler. Please go ahead.

Laura Niklason: Good morning, and thanks for taking the questions. A couple from me on the vascular trauma review: just what's your sense of the area of the filing that the agency needs more time to review, you know, clinical and non-clinical manufacturing for something else. And then, in terms of, you know, how much additional time FDA is going to need to complete the review, I think, Laura, earlier you indicated this could take a couple of months.

Alison Brassell: Hey, thank you. Good morning and thanks for taking the questions. A couple for me on the vascular trauma review, just what's your sense of the area of the filing that the agency needs more time to review, you know, clinical, non-clinical, manufacturing, or something else?

Laura Niklason: In June, we announced issuance of four new ICD-10 codes from the Centers for Medicare and Medicaid Services or CMS. These codes will be effective for hospital discharges, beginning in October 2024, and will cover procedures for replacing arteries in the upper or lower extremities using the ATAV. U.S, site also previously announced that we've hired Morgan Rankin as vice president of sales, joining U.S, site after 12 years at Teleflex Medical. Morgan most recently served as VP of sales, trauma, and emergency medicine at Teleflex, where she led a team of approximately 100 sales professionals. Our entire commercialization team is positioning U.S, site to be ready for commercial launch of the ATAV and Vascular trauma upon approval by the FDA in the future.

Alison Brassell: and then in terms of you know how much additional time FDA is going to need to complete the review I think Laura earlier you indicated this could take a couple of months

Laura Niklason: So, just help us understand, you know, what feedback from the agency indicates that this will be wrapped up in months as opposed to days or weeks. And then also, is it your sense that you will need to generate additional clinical data for FDA to be able to complete the review for vascular trauma? Or said another way, you know, what gives you confidence that the clinical data package you submitted is sufficient for FDA to grant approval in trauma?

Speaker Change: So just help us understand, you know, what feedback from the agency indicates that this will be wrapped up in months as opposed to days or weeks.

Speaker Change: And then also, is it your sense that you will need to generate additional clinical data for FDA to be able to complete the review?

Speaker Change: and vascular trauma, or said another way, what gives you confidence that the clinical data package you submitted is sufficient for FDA to grant approval in trauma?

Laura Niklason: So, Allison, I'll try to answer those questions as best I can with the extremely limited knowledge that I have. So, with respect to the timeline regarding days versus weeks versus months, you know, the senior CBER leadership said this could take, possibly take months, and they were not sure. And so, we have messaged the market exactly what the FDA told us. So, it might be sooner than that. It might But what we didn't want to do was message the market that this would be weeks or days when it may not be.

Speaker Change: So Allison, I'll try to answer those questions as best as I can with the extremely limited knowledge that I have. So with respect to the timeline,

Speaker: Turning now to our program in dialysis access.

Speaker Change: regarding days versus weeks versus months. You know, the senior CBER leadership said this could possibly take months, that they were not sure. And so we have messaged the market.

Laura Niklason: In July of 2024, we were incredibly pleased to announce positive results from the VO7 Phase III trial of the ATAV for arteriovenous access in hemodialysis patients who have end-stage renal distance. As a reminder, this trial enrolled 242 patients and is a prospective, multi-center, randomized study designed to evaluate the usability of the ATV for dialysis during the first 12 months after implantation. All participants will continue to be followed for a total of 24 months after implantation.

Speaker Change: exactly what the FDA told us. So it might be sooner than that, it might, but what we didn't want to do is message the market that this would be weeks or days when it may not be. So, you know, you now have the full extent of my knowledge.

Laura Niklason: So, you know, you now have the full extent of my knowledge on this topic. With respect to what part of the file they feel like they need more time for, again, I can't, I can't answer that.

Speaker Change: on this topic. With respect to what part of the file they feel like they need more time for, again, I can't answer that. There was literally no insight provided on what parts of the file they were continuing to work on.

Laura Niklason: There was literally no, no insight provided on what parts of the file they were continuing to work on. And thirdly, with respect to whether we think we will need more clinical data, I did not hear that on the call. And we have never, we have never gotten that indication in any part of the review. And I certainly didn't hear that on the call. And so that's where it stands.

Laura Niklason: The primary endpoint assessed functional patency or usability for dialysis access at 6 months. As well as secondary patency or blood flow through the conduit at 12 months. These assessments were co-primary endpoints and were compared to arteriovenous fistula, which is the current standard of care in dialysis access. At 6 months, 81% of patients had functional patency as compared to 66% of patients receiving a fistula. At 12 months, 68% of patients implanted with the ATV had secondary patency or blood flow through the conduit as compared to 62% of patients receiving an AV fistula.

Speaker Change: And thirdly, with respect to do we think we will need more clinical data? I did not hear that on the call. And we have never gotten that indication in any part of the review, and I certainly didn't hear that on the call.

Speaker Change: and so that's where it stands.

Laura Niklason: Got it. And then maybe just one follow-up question on the dialysis access data. Could you just clarify over what period adverse events are measured? Is that, you know, comment in the press release talking about AEs over the entire 12 months of the study, or just AEs during the time the ATEV or fistula was actually used for hemodialysis?

Speaker Change: Got it. And then maybe just one follow-up question on the dialysis access data. Could you just clarify over what period adverse events are measured? Is that...

Speaker Change: you know, comment in the press release talking about AEs over the entire 12 months of the study or just AEs during the time the ATEV or fistula, you know, was actually used for hemodialysis.

Laura Niklason: The joint test for superiority of the ATV versus AV fistula at 6 and 12 months was statistically significant. Patients who received the ATV also utilized the conduit significantly longer for hemodialysis during the first 12 months as compared to fistula. There were more adverse events reported in patients on the ATV treatment arm than on those in the dialysis fistula treatment arm, although the impact of this observation is not clear currently.

Speaker Change: I believe that it's AEs over the entire study because that's the typical way that adverse events are reported for study outcomes. So it's the entirety of the data that we have in hand.

Speaker Change: Got it. Thank you.

Speaker Change: Thank you. Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then 1 now.

Laura Niklason: We're highly encouraged by these results and we believe that they demonstrate the potential of the ATV to improve arteriovenous access in hemodialysis patients who are underserved by the current standard of care. We look forward to presenting more detailed clinical results including subgroup analyses at upcoming medical meetings.

Laura Niklason: I believe that it's AEs across the entire study because that's the typical way that adverse events are reported for study outcomes. So it's the entirety of the data that we have in hand. Got it. Thank you. Thank you. The next question we have comes from Kristen Kluska of Cantol Fitzgerald. Please go ahead. Hi, good morning, everybody, and congrats on the second positive phase three trial result for you in the last year. So maybe I'll start with AV Access.

Speaker Change: The next question we have comes from Kristen Kluska of Cantor Fitzgerald. Please go ahead.

Kristen Kluska: Hi, good morning everybody and congrats on the second positive phase 3 trial result for you in the last year. So maybe I'll start with AV access. Can you talk about some of the subgroup analysis data that you're going to share and ultimately why you believe that's going to be helpful with future commercial considerations? And to be clear, I'm not asking for the data, just which analyses in general you are conducting.

Kristen Kluska: Can you talk about some of the subgroup analyses data that you're going to share and ultimately why you believe that it's going to be helpful with future commercial considerations? And to be clear, I'm not asking for the data; I just want to know which analyses, in general, you are conducting. Yeah, thanks Kristen for that question. So, you know, as we've shared in previous quarterly calls and other presentations, it's clear from our work with Fresenius and other publications that there are certain subgroups of dialysis patients that tend to have a very hard time with dialysis access. They have a lot of failures and a lot of complications, and they're very expensive for the system.

Speaker: We're also making progress in our program in advance peripheral arterial disease or PAD. PAD is a cardiovascular disease of blood vessels, most commonly affecting arteries in the legs. As many as 40% of patients who require a bypass to repair arteries of the lower leg do not have an autologous vein available for re-vascularization. Autologous vein is the standard of care for such patients.

Speaker Change: Yeah, thanks Kristen for that question. So, you know, as we've shared in previous quarterly calls and other presentations, you know, it's clear from our work with Fresenius and other publications that there are certain subgroups of dialysis patients

Laura Niklason: In June of 2024, Dr. Todd Rasmussen and colleagues at the Mayo Clinic in Rochester, Minnesota published the outcomes of arterial bypass using the ATV in patients with chronic limb ischemia or severe PAD. In this paper, which appeared in the Journal of Vascular Surgery, all patients treated with the ATV for severe PAD had no suitable vein of their own for bypass and were treated under an investigator-a-sponsored trial. Outcomes for the ATV patency or blood flow and limb salvage in patients with severe PAD having no vein were comparable to historical control patients having similar disease but having received a bypass using their own vein at the Mayo Clinic.

Speaker Change: that tend to have a very hard time with dialysis access. They have a lot of failures and a lot of complications, and they're very expensive for the system.

Laura Niklason: These patients are often women, often diabetic or obese women. These patients often will not mature their fistulas and are stuck using synthetic grafts or catheters, and for all of those reasons, have higher complication rates and are more expensive. So it's known since this study compared our ATAV against our Terry Venus Fistula, it's known in the literature that there are certain demographics that have poorer maturation rates for their Fistula. So underrepresented minorities have different maturation rates for their Fistulas; the elderly, women, diabetics, et cetera.

Speaker Change: These patients are often women, often diabetic or obese women. These patients often will not mature their fistulas and are...

Speaker Change: stuck using synthetic grafts or catheters and, for all of those reasons, have higher complication rates and are more expensive.

Laura Niklason: So built into our statistical analysis plan, we had pre-specified, looking at these different subgroups to try to understand what the delta is between the ATEV and dialysis, particularly in these subgroups, the ATEV and FISHLA, I'm sorry, particularly in these subgroups where FISHLA is known not to work very well. So, again, there's nothing magic here. This is just sort of the standard subgroups that are known in the literature to be problematic.

Speaker Change: So, it's known since this...

Speaker Change: study compared our ATEV against

Speaker Change: arteriovenous fistula.

Speaker Change: It's known in the literature that there are certain demographics that have poorer maturation rates for their fistulas, so underrepresented minorities have different fistula maturation rates, the elderly, women, diabetics, etc.

Laura Niklason: Mayo Investigators reported that patency and limb salvage were similar for patients receiving ATV and patients receiving bypass with their own vein historically. This result highlights the potential impact that Humocyte's ATV may have on patients suffering from severe PAD and having no vein of their own to perform a bypass operation.

Laura Niklason: And I think diving down into those groups will really give us a better sense of which patients are the most underserved currently and which can benefit the most from ATEV and Dialysis. Okay, thanks. Appreciate that. And then just one on vascular trauma.

Speaker Change: So, built into our statistical analysis plan, we had pre-specified.

Speaker Change: looking at these different subgroups.

Speaker Change: to try to understand what the delta is between the ATEV and dialysis.

Laura Niklason: In July, the FDA also granted an ARMAT designation for the ATV in the PAD indication. Following vascular trauma and AV access in hemodialysis, this marks the third indication for which the ATV has been granted this ARMAT designation. This designation is designed to provide pathways for expedited development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. This designation allows for close interactions with the FDA and potentially an expedited or priority review of any BLA.

Speaker Change: particularly in these subgroups, the ATEV and FISHLA, I'm sorry, particularly in these subgroups where FISHLA is known not to work very well.

Speaker Change: So again, there's nothing magic here, this is just sort of the standard subgroups that are known in the literature to be problematic.

Speaker Change: And I think diving down into those groups will really give us a better sense of which patients are the most underserved currently and which can benefit the most.

Laura Niklason: At the same time, we also received clearance for a newly issued IND for the ATV in the PAD indication. Today, the ATV has been evaluated in two Phase 2 trials in PAD with patients followed for as long as six years. In addition, the ongoing study at the Mayo Clinic is evaluating the ATV in 30 patients with chronic limb-threatening ischemia. All patients treated with the ATV in PAD to date have had no autologous vein available for re-vascularization and we believe the ATV may represent an important therapeutic alternative for these patients.

Laura Niklason: Sounds like the clinical site and the manufacturing inspections occurred a few months ago. Can you just give us a sense of how those inspections went and, in terms of the follow-up items that were required, was there anything in particular you were working with the FDA on addressing? Thank you again. So, we had a total of five inspections. I would say all of those inspections went very well.

Speaker Change: Okay thanks, appreciate that. And then just one on vascular trauma, sounds like the the clinical site and the manufacturing inspections occurred a few months ago. Can you just give us a sense of how those those inspections went and in terms of the follow-up items that were required that you know is there anything in particular you were working with the FDA on addressing? Thank you again.

Speaker Change: So we had a total of five inspections. I would say all of those inspections went very well.

Laura Niklason: You know, in terms of follow-up items, there are a small number of standard follow-up items on assays and CMC having to do with validation of certain methods. But these are sort of standard things that we've worked out with the agency; some of those were completed pre-padoofa. Some of those were slated for after-padoofa. For example, one study is shipping the product during winter, and we couldn't do that until winter.

Speaker Change: In terms of follow-up items, there's a small number of standard follow-up items on assays and CMC having to do with

Laura Niklason: Returning now to diabetes results from an ongoing pre-clinical study of our biovascular pancreas or BVP product candidate continue to be featured in medical meetings. The BVP is designed to enable the delivery and survival of insulin-producing eyelets as a potential treatment for type 1 diabetes.

Speaker Change: validation of certain methods?

Speaker Change: But these are sort of standard things that we've worked out with the agency.

Speaker Change: were completed pre-PDUFA, some of those were slated for post-PDUFA. For example, one study is shipping the product during winter.

Laura Niklason: So we agreed to do that in winter. But these are sort of standard, I don't want to say cookie cutter, but these are standard validation and test procedures that we do not believe are impacting the timing of the file. Thanks again. Thank you. The next question we have comes from Bruce Jackson of the Benchmore Company. Please go ahead. The next question we have comes from Bruce Jackson of the Benchmore Company. Hi, good morning.

Laura Niklason: At the breakthrough T1D beta cell consortium meeting in June, scientists presented data in which stem cell-derived eyelets were observed to restore normal blood sugar in diabetic mice. In the mice, the stem cell eyelets survived and continued to produce insulin with no evidence of adverse events from the stem cell-derived eyelets. These experiments were performed in collaboration with the diabetes research institute at the University of Miami.

Speaker Change: and we couldn't do that until winter.

Speaker Change: So we agreed to do that in winter. So, you know, but there's, these are sort of standard, I don't want to say cookie cutter, but these are standard.

Speaker Change: validation and test procedures that we do not believe are impacting the timing of the file.

Speaker Change: Thanks again.

Speaker Change: Thank you for watching, see you in the next video!

Speaker Change: Thank you.

Speaker Change: The next question we have comes from Bruce Jackson of the Benchmark Company. Please go ahead.

Laura Niklason: In addition, we also presented results from a non-human primate study at the American Diabetes Association Annual Meeting in June. In this study, primate BVP implants showed eyelets survival and continued insulin production throughout the three-month duration of the study, eyelets also developed capillaries to support survival of the insulin-producing cells. This study was also performed in collaboration with the diabetes research institute.

Bruce Jackson: Thank you for taking my questions. I was hoping to get an update on the new technology add-on payment application. Are you still going to apply for it this October? And how does the delay in FDA approval factor into that? Bruce, that's a good question.

Bruce Jackson: Hi, good morning and thank you for taking my questions. I was hoping to get an update on the new technology add-on payment application. Are you still going to apply for it this October and how does the delay in the FDA approval factor into that?

Laura Niklason: Thank you very much. As you know, we got codes, ICD-10 codes from CMS in June, and that's a prerequisite for filing an NTAP application. To the best of my knowledge, unless the rules have changed, but to the best of my knowledge, even without approval, we can file for an NTAP payment during this cycle. NTAP applications are only allowed once per year, and they typically, the deadline is typically around October 1st, so we can file for an Entap ad on payment.

Speaker Change: Bruce, that's a good question. Thank you very much. As you know, we got...

Speaker Change: ICD-10 codes from CMS in June, and that's a prerequisite for filing an NTAP application.

Laura Niklason: We also presented results from studies of our small caliber, 3.5 millimeter diameter ATAV in the coronary artery bypass grafting or cabbage setting.

Speaker Change: To the best of my knowledge, unless the rules have changed, but to the best of my knowledge, even without approval, we can file for an NTAP payment.

Laura Niklason: This presentation was at the tissue engineering and regenerative medicine conference in June. Preclinical, even six month studies have been conducted in non-human primates, to support the planned advancement of the small diameter Atev into phase one human clinical trials in cabbage. We have observed remodeling of the Atev to a diameter that closely matches that of the native coronary vessels, which is an outcome that has not been observed with any other conduit previously. This finding demonstrates the favorable biological response of the host to the engineered human arteries in the coronary system.

Speaker Change: During this cycle, NTAP applications are only allowed once per year, and the deadline is typically around October 1st.

Bruce Jackson: And so long as we have approval, I believe, I believe, before June of next year, then that Entap payment would kick in in October of 2025. So this delay on the front end with our PDUFA date, in my mind, does not change our plans for filing an NTAP application this October. Okay, great. That's it for me.

Speaker Change: So, we can file for an NTAP add-on payment, and so long as we have approval, I believe, I believe, before June of next year, then that NTAP payment would kick in in October of 2025.

Speaker Change: So, this delay on the front end with our PDUFA date, in my mind, does not change our plans for filing an NTAP application this October.

Laura Niklason: We are very pleased that the preclinical studies of the BVP and small diameter Atev continue to show promising results, and will continue to update on the progress of this and other pipeline programs as they advance.

Speaker Change: Okay, great. That's it for me. Thank you.

Laura Niklason: Thank you. Thank you, sir. Ladies and gentlemen, we have reached the end of our question and answer session, and I would like to turn the call back to Dr. Niklason for closing remarks. Please go ahead.

Speaker Change: Go to Beadaholique.com for all of your beading supplies needs!

Speaker Change: Thank you, sir. Ladies and gentlemen, we have reached the end of our question and answer session, and I would like to turn the call back to Dr. Niklason for closing remarks. Please go ahead.

Laura Niklason: Finally, last quarter, we welcomed pharmaceutical industry veteran, Dr. John P. Bamforth, and the distinguished health system leader and physician, Dr. Tony Jones, to the company's board of directors. John and Tony are both distinguished commercialization and health system leaders whose experience and perspectives will be extremely valuable as we prepare for planned commercial launch of the Atev Invascular Trauma.

Laura Niklason: Well, I'd like to thank everybody on the call, including our analysts and our investors and our, and any board members that might be on the call and our leadership. You know, this has been a very interesting part of Humacyte's journey. Again, we have full confidence that we will receive approval in the trauma indication for ATEV. We believe that ATEV provides important benefits for patients, in terms of limb salvage and infection.

Dr. Niklason: Well, I'd like to thank everybody on the call, including our analysts and our investors and our

Laura Niklason: We believe this is an important adjunct in therapy for both civilian and military trauma. And so we're pushing forward, and we're looking forward to not only the trauma indication but also future approvals and other indications as well. I continue to be very excited about our prospects, and it's going to be a very interesting journey. So, thank you for coming along with us on the journey. Thank you. Ladies and gentlemen, that concludes today's conference. Thank you for joining us. You may now disconnect your lines.

Dr. Niklason: and any board members that might be on the call and our leadership.

Speaker Change: You know, this has been a very interesting part of HumaCyte's journey. Again, we have full confidence that we will receive approval in the trauma indication for ATEV.

Dale Sander: With that, I will now turn it over to Dale for a review of our financial results and other business developments. Thank you, Laura. Now turning to the financial report that came out this morning.

Speaker Change: We believe that ATEV provides important benefits for patients in terms of limb salvage, in terms of infection. We believe this is an important adjunct in therapy for both civilian and military trauma.

Dale Sander: There were no revenues in any of the quarters or six month periods reported today. Revenue, sorry, research and development expenses were $23.8 million for the second quarter of 2024, compared to $20.5 million for the second quarter of 2023, and we're $45.0 million for the six months into June 30, 2024, compared to $37.8 million for the six months into June 30, 2023. The current priority increases resulted primarily from increased materials and personnel expenses to support expanded research and development initiatives, primarily in the areas of expanding our manufacturing activities, and in support of the FDA review of the BLA invascular trauma.

Speaker Change: and so that we're pushing forward.

Speaker Change: and we are looking forward to not only the trauma indication but also future approvals and other indications as well. I continue to be very excited about our prospects and it is going to be a very interesting journey. So thank you for coming along with us on the journey.

Speaker Change: Thank you. Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect your lines.

Dale Sander: General and administrative expenses were $5.7 million for the second quarter of 2024, compared to $6.2 million for the second quarter of 2023, and we're $11.1 million for the six months into June 30, 2024, compared to $11.4 million for the six months into June 30, 2023. The decreases during 2024 resulted primarily from decreased non-cash stock compensation expense, partially offset by increased personnel expenses and increased professional fees. Other net income or expense was net expense of $27.2 million for the second quarter of 2024, compared to net income of $4.0 million for the second quarter of 2023.

Dale Sander: For the six months into June 30, 2024, other net expense was $32.5 million compared to other net expense of $10.4 million for the six months ended June 30, 2023. The increase in other net expense for the second quarter of 2024, and for the six months ended June 30, 2024, compared to 2023, resulted primarily from the non-cash re-measurement of the contingent or not liability associated with the company's August 2021 merger with Alpha Health Care Acquisition Corps.

Dale Sander: Net loss was 56.7 million for the second quarter of 2024, compared to 22.7 million for the second quarter of 2023, net loss was 88.6 million for the six months ended June 30, 2024, compared to 59.7 million for the six months ended June 30, 2023, the current period increase in net loss resulted primarily from the non-cash re-measurement of the contingent or not liability, and net operating expense increases described previously.

Dale Sander: The company reported cash and cash equivalence of 93.6 million as of June 30, 2024. Total net cash provided was 13.1 million for the first six months of 2024, compared to net cash used of 35.2 million for the first six months of 2023. The increase in net cash provided resulted primarily from the receipt of approximately 43 million in that proceeds from an underwritten public offering that's common stock in March 2024, and 20 million proceeds from an additional draw under our funding arrangement with Overland Capital Management.

Laura Niklason: With that, I'd like to turn it back to Laura for some concluding remarks. Thank you, Dale. We're very excited about the future of human sight. We're confident that the FDA approval of the ATV Invascular Trauma is coming soon, and we and our entire organization are continuing to prepare for commercialization of our first product, if approved. We also remain committed to advancing our pipeline programs, which continue to demonstrate encouraging results and underscore the promise of the ATV across a wide range of diseases, injuries, and chronic conditions. This is a transformational period for us, and we're grateful for your continued support. Thank you for joining us on the call today.

Operator: Operator, we're ready to take questions. Thank you.

Operator: Ladies and gentlemen, at this time, we will be conducting a question and on the phone, keep out a confirmation tone. We'll indicate your line is in the question 2. You may press star and then 2 if you would like to remove your question from the queue. For participants using speaking equipment, it may be necessary to pick up your handset before pressing the star keys.

Operator: Again, if you would like to ask a question, please press star and then 1 now.

Ryan Zimmerman: The first question that we have comes from Ryan Zimmerman of BTIG. Please go ahead. Good morning.

Laura Niklason: Thanks for taking our questions, Lauren Dale. And you know, apologies for this. Myopic focus here on Vascular trauma, but just a couple of questions for me. If the FDA does communicate with you, I guess I'm curious, you know, what should we expect a new date for Clarence, or will it certainly provide a Clarence in a future date as you understand it today? And then, you know, as part of that, what impact does this have on your BLA submission timing for AV access, which I think is expected later this year, and I have one follow-up. Thank you.

Dale Sander: So, Ryan, this is Lauren Niklason, thanks for that question. As far as what to expect, as far as a new pedophidate or timing on a decision, I wish I could provide more clarity for this group, but I can't. You know, again, the phone call from the senior leadership at Seabur on Friday said simply that they need more time, and they did not give us insight into a new date or how we would be informed.

Dale Sander: That said, I would expect that within the next several months, we will hear a decision, but the exact mechanics of that is very hard for me to predict. I just can't at this stage. With respect to the supplemental BLA that we had been planning and hoping to file in dialysis access, from my standpoint, that's still on track. You know, the reality is that, you know, we just got top-line results in our Phase III trial a couple weeks ago.

Dale Sander: We're still processing those results. Our plan had been assuming FDA approval in trauma in the second half of this year. Our plan had been to initiate commercial launch, and then look at filing a supplemental BLA perhaps sometime in 2025. So I don't think we've messaged the market that we were going to file a supplemental BLA in late 24. So, you know, from my standpoint, you know, barring any other changes in timing from the FDA, the communicated timing on BLA filing for dialysis kind of remains the same. You know, depending on conversations with the FDA, we would hope to file sometime in 2025. So that remains on track as near as I can tell. Okay, very helpful.

Dale Sander: And then for Dale, you know, how do you think about operating expenses and cash burn during this interim period just given the delay impact? Are you, you know, pulling back anything? Are you, you know, full steam ahead, foot on the gas? Help us understand kind of how you're managing your cash in this kind of limbo period that you're in right now as a result of Friday's update. Yeah, Ryan, I think the take extrapolate from what Laura said, you know, we don't know what the delay will be at this instance, but the entire BLA process has been one that's been very iterative.

Dale Sander: And so our expectation is that as these weeks unfold, we're going to have a better sense of what that timeline is. You know, based on our assessment of timeline to completing this process, you know, then we will, you know, apply that knowledge and be prudent in terms of how we undertake new programs and how we we manage operating expenses. I think, you know, being essentially two working days out from the notice from the update, there's limits to what we know right now.

Dale Sander: What we're certainly thinking about how we're going to respond to different potential outcomes in terms of what that that timeline is, but it's a little early to give specifics in terms of how we might change our operations under different scenarios of timelines. But that's clearly we're looking at it very closely.

Ryan Zimmerman: Understood. Thank you for taking the questions. Thank you.

Joshua Jennings: The next question we have comes from Josh Jennings of TD Cohen and Company. Please go ahead. Hi, good morning. Thanks for taking the questions, Lauren Dale. I wanted to just ask about the Vassier trauma data set and just call out that adverse events were higher in the ATAV study group. I don't think that you're disclosing much around that, but the efficacy was not impacted our assumption that these are minor adverse events in total, but just wanted to see if there's any other color you can share on measure.

Joshua Jennings: Yeah, so Josh just to clarify, that was on dialysis, that's not on trauma. Thank you. Sorry about that. I appreciate it. I just don't want to, I just don't want our listeners to think that was on trauma. Yeah, so on dialysis, yeah, we're still digging into that. You know, most of these adverse events are minor as you know in dialysis access, you know, these patients undergo a lot of procedures in general to maintain access patency.

Joshua Jennings: It's just how life is for these patients. I will say very clearly that we have no new safety signals for this conduit. None. We have, it's not like we've seen something new that we haven't seen before. So the increased number of adverse events, I'm not sure, it could be related to the fact that our vessels were used for a longer period of time during the first year and got more needle punctures or something else.

Laura Niklason: So it's hard for us to, for me, to comment on right now, but we're in the process of sorting that out and we expect to share this information at medical meetings later this year. Understood.

Laura Niklason: In the second one on the UV access indication and the top line data, just and how involved is for Sennius in terms of aggregating the data, how much of a scene and I guess which, what's next steps in terms of that agreement and collaboration on two fronts, one just continued collection of cost effectiveness data, and then two, I think down the line, Sennius is agreed to use a tab in any indication where clinical value has been demonstrated. Well, so certainly we've worked with a number of Sennius centers, dialysis access centers, as part of the VO7 phase three trial.

Laura Niklason: That said, Sennius is not active in aggregating or analyzing our data, you know, that that's a human sight endeavor for sure. But as you mentioned, you know, our partnership with them really does focus on the health economics and the cost benefit analysis for different demographics of dialysis patients. So we are working closely with Sennius actually on putting together a publication on some of the costs that are incurred with patients who have multiple access failures and what that costs the system.

Laura Niklason: And we're also working with them on a similar project in Europe. So they've been great partners for that, and you're right. Forsenius, you know, as part of our commercialization agreement, they have agreed to adopt the ATAV in dialysis for their centers in patients where the clinical results and the health economic results make sense. So working with them to identify those patient populations, which where the health economics become really prohibitive for dialysis access, that's a key part of our long-term market adoption strategy in the U.S, and they're working with us very closely on that.

Joshua Jennings: Great, just one more to sneak in, just on the PAD indication, and you know, you've had some positive updates and on that designation.

Laura Niklason: Just wanted to, let's share if you do this earlier in the call or prepare marks, so I would just any next steps outline you can provide in terms of moving forward with initiation of a clinical trial and getting up and running. Thanks a lot. Yes, well, as I may have mentioned on prior calls, we've certainly had multiple requests from vascular surgeons to initiate a Phase 3 trial in PAD. I think there's a lot of excitement on the clinical vascular surgery side for looking at this as an option for patients who are facing potential amputation.

Laura Niklason: And we are designing that trial, so we're doing the intellectual work around that. But I think that we're going to have to play it by ear in terms of the timing of the approval in trauma and our cash runway. Again, we remain a pre-revenue company, and so we'll just have to be holistic and mindful as we think about when to start a Phase 3 trial in PAD, given that that would be a third Phase 3 program, so after trauma and dialysis. So it's something that we're thinking about very actively, but as Dale said with respect to our finances and our cash runway, we're evaluating this month over month. Understood. Thanks for that. Thank you.

Allison Bratzel: The next question we have comes from Alison Brassel of Paisa Sandler. Please go ahead. Hey, thank you. Good morning, and thanks for taking the questions. A couple from me on the vascular trauma review. Just what's your sense of the area of the filing that the agency needs more time to review? So clinical, non-clinical, manufacturing, or something else. And then in terms of how much additional time FDA is going to need to complete the review, I think Laura earlier, you indicated this could take a couple of months.

Allison Bratzel: So just help us understand what feedback from the agency indicates that this will be wrapped up in months, as opposed to days or weeks. And then also, is it your sense that you will need to generate additional clinical data for FDA to be able to complete the review in vascular trauma or set another way, you know, what gives you confidence that the clinical data package you submitted is sufficient for FDA to grant approval in trauma.

Laura Niklason: So Alison, I'll try to answer those questions as best as I can with the extremely limited knowledge that I have. So with respect to the timeline, regarding days versus weeks versus months, you know, the senior seabird leadership said this could possibly take months that they were not sure. And so we have messaged the market exactly what the FDA told us. So it might be sooner than that. It might. But what we didn't want to do is message the market that this would be weeks or days when it may not be.

Laura Niklason: So, you know, you know, have the full extent of my knowledge on this topic. With respect to what part of the file, they feel like they need more time for. Again, I can't answer that. There was literally no insight provided on what parts of the file they were continuing to work, on. And thirdly, with respect to do we think we will need more clinical data, I did not hear that on the call. And we have never gotten that indication in any part of the review. And I certainly didn't hear that on the call. And so that's where it stands. Got it.

Laura Niklason: And then maybe just one follow up question on the dialysis access data. Could you just clarify over what period adverse events are measured? Is that, you know, comment in the press release talking about AES over the entire 12 months of the study or just AES during the time the AES have or Fischila, you know, was actually used for PMO dialysis. I believe that it's AES over the entire study because that's the typical way that adverse events are reported for study outcomes. So it's the entirety of the data that we have in hand. Got it. Thank you.

Kristen Kluska: Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then one now. The next question we have comes from Kristin Puska of Council Fitzgerald. Please go ahead. Hi, good morning, everybody. And congrats on the second positive phase three trial result for you in the last year. So maybe I'll start with AV access.

Laura Niklason: Can you talk about some of the subgroup analysis data that you're going to share and ultimately why you believe that's going to be helpful with future commercial considerations and to be clear, I'm not asking for the data, just which analyses in general you are conducting. Yeah, thanks, Kristin, for that question. So, you know, as we've shared in previous quarterly calls and other presentations, you know, it's clear from our work with Forcinius and other publications that there are certain subgroups of dialysis patients that tend to have a very hard time with dialysis access.

Laura Niklason: They have a lot of failures and a lot of complications. And they're very expensive for the system. These patients are often women, often diabetic or obese women. These patients often will not mature their fistulas and are stuck using synthetic graphs or catheters. And for all of those reasons have higher complication rates and are more expensive. So it's known since this study compared our ATAV against arterial venous fistula, it's known in the literature that there are certain demographics that have poorer maturation rates for their fistulas.

Laura Niklason: So underrepresented minorities have different fistula maturation rates, the elderly women, diabetics, etc. So built into our statistical analysis plan, we had pre-specified looking at these different subgroups to try to understand what the delta is between the ATAV and dialysis, particularly in the ATAV and fistula, I'm sorry, particularly in these subgroups where fistula is known not to work very well. So again, these are, there's nothing magic here, this is just sort of the standard subgroups that are known in the literature to be problematic. And I think diving down into those groups will really give us a better sense of which patients are the most underserved currently and which can benefit the most, from the ATV and dialysis. Okay, thanks.

Laura Niklason: Appreciate that.

Laura Niklason: And then just one on vascular trauma. Sounds like the clinical site and the manufacturing inspections occurred a few months ago. Can you just give us a sense of how those inspections went and in terms of the follow-up items that were required, did that, you know, is there anything in particular you were working with the FDA on addressing?

Laura Niklason: Thank you again. So we had a total of five inspections. I would say all of those inspections went very well. You know, in terms of follow-up items, there are, there's a small number of standard follow-up items on assays and CMC having to do with validation of certain methods. But these are sort of standard things that we've, that we've worked out with the agency. Some of those are, we're, we're completed, you know, pre-padoofa.

Laura Niklason: Some of those were slated for post-padoofa. For example, one study is, is shipping the product during winter. And we couldn't do that until winter. So, so we agreed to do that in winter. So, you know, but there's, there's, these are sort of standard, I don't want to say cookie cutter, but these are, these are standard validation and test procedures that we do not believe are impacting the timing of the file. Thanks again.

Speaker: Thank you.

Bruce Jackson: The next question we have comes from Bruce Jackson of the benchmark company.

Bruce Jackson: Please go ahead. I did morning. Thank you for taking my questions. I was hoping to do an update on the new technology add-on payment application. Are you still going to apply for it this October? And how does he on delay in the, the FDA approval factor into that?

Laura Niklason: Bruce, that's a good question. Thank you very much. As you know, we got codes, ICD-10 codes from CMS in June. And that's a prerequisite for filing an Entap application. To the best of my knowledge, unless the rules have changed, but to the best of my knowledge, even without approval, for an Entap payment during this cycle, Entap applications are only allowed once per year, and they typically, the deadline is typically around October 1st.

Laura Niklason: So, we can file for an Entap add-on payment, and so long as we have approval, I believe, I believe, before June of next year, then that Entap payment would kick in in October of 2025. So, this delay on the front end with our pedophadate in my mind does not change our plans for filing an Entap application this October.

Bruce Jackson: Okay, great. That's it for me. Thank you. Thank you so.

Operator: Ladies and gentlemen, we have reached the end of our question and answer session.

Laura Niklason: And I would like to turn the call back to Dr. Nicholson for closing remarks. Please go ahead.

Laura Niklason: Well, I'd like to thank everybody on the call, including our analysts and our investors and any board members that might be on the call and our leadership. This has been a very interesting part of Humocyte's journey. Again, we have full confidence that we will receive approval in the trauma indication for ATV. We believe that ATV provides important benefits for patients in terms of limb salvage, in terms of infection. We believe this is an important adjunct in therapy for both civilian and military trauma.

Laura Niklason: And so that we're pushing forward and we're looking forward to not only the trauma indication, but also future approvals and other indications as well. I continue to be very excited about our prospects and it's going to be a very interesting journey. So thank you for coming along with us on the journey. Thank you.

Operator: Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect your lines.