Kidney Failure, Chronic

NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the first quarter ended September 30, 2024. Mesoblast Chief Executive Silviu Itescu said: “We have had an extremely busy and productive quarter starting right from the outset with the filing of our Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGvHD). We continue to be engaged in active and ongoing interactions with the agency as part of the review process. We are anticipating a decision prior to or on the FDA’s Prescription Drug User Fee Act (PDUFA) goal date of January 7, 2025.” “During the period we put in place a strategic financing to ensure that the Company is well capitalized for a commercial launch of RYONCIL. This has been structured as a convertible note subscription agreement with our largest shareholder for issue, at Mesoblast’s sole discretion, up to US$50.0 million convertible notes following approval of RYONCIL by FDA. At the same time, we have maintained a strong focus on our cost control with net operating spend for the period of US$10.5 million, down 26% on the prior corresponding quarter.” “I look forward to providing an update at our Annual General Meeting (AGM) on November 15th 12.00 noon AEDT (November 14th 8.00pm EST).” KEY HIGHLIGHTS Ryoncil® (Remestemcel-L) for Steroid-Refractory Acute Graft Versus Host Disease – Potential FDA Approval There are no approved treatments for children under 12 with steroid-refractory acute GvHD, making approval of a safe and effective treatment for this vulnerable population the most urgent need.Mesoblast resubmitted its BLA to FDA for approval of RYONCIL on July 8, 2024 and anticipates a decision prior to or on the FDA’s Prescription Drug User Fee Act (PDUFA) goal date of January 7, 2025.FDA has already conducted the Pre-License Inspection (PLI) of the manufacturing process for RYONCIL in May 2023 and this did not result in the issuance of any Form 483.Inventory has been manufactured and there is an established supply chain to ensure cryopreserved product is available for delivery to meet the needs of each site immediately post approval, with ability to scale up as necessary going forward.We have been working diligently to lay the groundwork for a successful launch of RYONCIL, including hiring select senior positions to implement a targeted commercial strategy since 50% of pediatric transplants are performed at just 15 centers.Post approval implementation will initially target those centers with greatest experience using the RYONCIL product and highest volume, with staged rollout beyond. Revascor® (Rexlemestrocel-L) for Pediatric Congenital Heart Disease - Hypoplastic Left Heart Syndrome Earlier this year, FDA granted Mesoblast’s second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell product REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for treatment of children with hypoplastic left heart syndrome (HLHS), a potentially life-threatening congenital heart condition. Results from a blinded, randomized, placebo-controlled prospective trial of REVASCOR conducted in the United States in children with HLHS were published in the December 2023 issue of the peer reviewed The Journal of Thoracic and Cardiovascular Surgery Open (JTCVS Open).1 A single intramyocardial administration of REVASCOR at the time of staged surgery resulted in the desired outcome of significantly larger increases in left ventricular (LV) end-systolic and end-diastolic volumes over 12 months compared with controls as measured by 3D echocardiography (p=0.009 & p=0.020 respectively).These changes are indicative of clinically important growth of the small left ventricle, facilitating the ability to have a successful surgical correction, known as full biventricular (BiV) conversion, which allows for a normal two ventricle circulation.Without full BiV conversion the right heart chamber is under excessive strain with increased risk of heart failure, liver cirrhosis, and death.RPDD demonstrates that the disease is serious or life-threatening and the manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents, and that the disease is a rare disease or condition.On FDA approval of a BLA for REVASCOR for the treatment of HLHS, Mesoblast may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed for any subsequent marketing application or may be sold or transferred to a third party.Mesoblast plans to meet with FDA to discuss the clinical data to support regulatory approval for REVASCOR in children with this life-threatening condition. REVASCOR for Chronic Heart Failure with Reduced Ejection Fraction (HFrEF) and Persistent Inflammation In March FDA informed Mesoblast that it supports an accelerated approval pathway for its second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell product REVASCOR, for patients with end-stage ischemic HFrEF kept alive with a left ventricular assist device (LVAD).This followed presentation to FDA of the results of two complementary randomized controlled trials of REVASCOR, one in patients with end-stage HFrEF and LVADs and a second in advanced NYHA class II/III HFrEF patients.Mesoblast has received RMAT designation for rexlemestrocel-L in the treatment of end-stage heart failure in LVAD patients and intends to meet with FDA, after the meeting on HLHS, to discuss data presentation, timing and FDA expectations for an accelerated approval filing in these patients. Rexlemestrocel-L for Chronic Low Back Pain associated with Degenerative Disc Disease – Phase 3 Program The confirmatory Phase 3 trial of Mesoblast’s second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell product rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease (DDD) of less than five years duration has commenced enrollment at multiple sites across the United States. FDA has previously agreed on the design of this 300-patient randomized, placebo-controlled confirmatory Phase 3 trial, and the 12-month primary endpoint of pain reduction as an approvable indication.This endpoint was successfully met in Mesoblast’s first Phase 3 trial.Key secondary measures include improvement in quality of life and function.A particular focus is on treatment of patients on opioids, since discogenic back pain accounts for approximately 50% of prescription opioid usage in the US.Significant pain reduction and opioid cessation were observed in Mesoblast’s first Phase 3 trial.FDA has designated rexlemestrocel-L a Regenerative Medicine Advanced Therapy (RMAT) for the treatment of chronic low back pain. RMAT designation provides all the benefits of Breakthrough and Fast Track designations, including rolling review and eligibility for priority review on filing of a BLA. FINANCIAL REPORT We have continued our disciplined financial management strategy focused on ensuring that we are well-positioned to execute our clinical, manufacturing, and commercialization plans while maintaining conservative fiscal practices. The successful implementation of our cost containment plan over the past 12 months and the re-prioritization of projects has enabled us to reduce cash expenditure whilst still making significant strides forward on key programs as outlined above. To ensure that the Company is well capitalized for a commercial launch of RYONCIL, we recently entered into a convertible note subscription agreement with our largest shareholder for issue, at Mesoblast’s sole discretion, up to US$50.0 million convertible notes following approval of RYONCIL by FDA. First Quarter Results Cash balance at September 30, 2024 is US$51.1 million, with additional US$60.0 million available from existing financing facilities on RYONCIL approval.Net operating cash spend of US$10.5 million for the first quarter FY2025. 26% (US$3.7 million) reduction in net operating cash spend for the first quarter FY2025 versus the prior comparative quarter in FY2024. Other Fees to Non-Executive Directors were nil, consulting payments to Non-Executive Director were US$40,000 and salary payments to full-time Executive Directors were US$231,552, detailed in Item 6 of the Appendix 4C cash flow report for the quarter.2 From 1 August 2024, Non-Executive directors have voluntarily deferred 50% cash payment of their director fees and agreed to receive the remaining 50% of their fees in equity-based incentives and Executive Directors (our Chief Executive and Chief Medical Officers) have voluntarily reduced their base salaries for FY25 by 30% in lieu of accepting equity-based incentives. A copy of the Appendix 4C – Quarterly Cash Flow Report for the first quarter FY2025 is available on the investor page of the company’s website www.mesoblast.com. About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease, and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast References / Footnotes Wittenberg RE et al. Prospective randomized controlled trial of the safety and feasibility of a novel mesenchymal precursor cell therapy in hypoplastic left heart syndrome, JTCVS Open Volume 16, Dec 2023.As required by ASX listing rule 4.7 and reported in Item 6 of the Appendix 4C, reported are the aggregated total payments to related parties being Executive Directors and Non-Executive Directors. Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including any future decision that the FDA may make on the BLA for remestemcel-L for pediatric patients with SR-aGVHD), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact: Corporate Communications / InvestorsMediaPaul HughesBlueDot MediaT: +61 3 9639 6036Steve DabkowskiE: investors@mesoblast.comT: +61 419 880 486 E: steve@bluedot.net.au

Clinical Trials at American Society of Nephrology (ASN) – Kidney Week 2024 SAN FRANCISCO, Oct. 28, 2024 /PRNewswire/ -- Kind Pharmaceutical ("Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC"), a clinical-stage biopharmaceutical company focused on developing innovative medicines to treat hematological diseases and cancers, today announced that positive results of four clinical trials from its leading program AND017 to treat anemia in non-dialysis dependent chronic kidney disease (NDD-CKD) and dialysis-dependent chronic kidney disease (DD-CKD) were presented at annual meeting of American Society of Nephrology (ASN) Kidney Week in San Diego. The four clinical trials are first-in-human trial in healthy subjects in Austria (clinical trial "AU-001", NCT04751539), food effects on pharmacokinetics (PK) in China (clinical trial "CN-101", NCT04712500), phase 2 trial in anemia in NDD CKD in both US and China (clinical trial "MN-201", NCT05035641), and phase 2 trial in anemia in DD CKD in both US and China (clinical trial "MN-202", NCT05265325). In the AU-001 double-blinded, placebo-controlled, first-in-human clinical trial in healthy subjects in Australia, AND017 demonstrated favorable linear oral pharmacokinetics (PK) with T1/2 (elimination half-life) between 11.9 h and 19.7 h for the SAD part of trial (dosed from 1 mg to 50 mg) and T1/2 between 10.1 h and 19.4 h for the MAD part of trial (dosed from 4 mg to 30 mg QD for 10 days). In this trial, preliminary PD markers (EPO, Hb) were observed. In AU-001 trial, AND017 was safe and well tolerated in all doses (1 mg to 50 mg in SAD and 4 mg to 30 mg in MAD trials). In the CN-101 phase I, randomized, open-label, two-sequence, two-period, crossover, single dose (10 mg) trial, the effect of food on the PK of AND017 was studied in non-elderly healthy subjects in China. The Fed/Fasted ratio of geometric mean of Cmax was 79.61% with 90% CI (73.40, 86.34) and the Fed/Fasted ratio of geometric mean of AUC0-inf was 99.93% with 90% CI (96.31, 103,68). The CN-101 trial demonstrated that AND017 with the current formulation can be administered with or without food. In the MN-201 phase II, randomized, double-blinded, placebo-controlled, dose ranging study in U.S. and China, a total of 113 NDD CKD patients were randomized at 1:1:1:1 ratio to one of the four treatment groups to receive AND017 at three different doses of 8 mg, 12 mg, 16 mg, or placebo three times weekly (TIW) (28, 29, 28, and 28 patients respectively) in the first 5-week fixed-dose period; at Week 6 the drug-treated patients were combined and re-randomized to two TIW and once weekly (QW) dosing regimens to enter the 8-week titration period. At Week 6, the end of the titration period, all AND017 dose groups had significantly higher hemoglobin level (Hb) rise rate from baseline compared to placebo group; the dose of AND017 and the rate of rise in Hb were linearly correlated. After switching from the TIW dosing in the fixed-dose period, the Hb levels in both the TIW and QW dosing regimens maintained in the targeted range in the 8-week dose titration period. For the safety assessment, treatment emergent adverse events (TEAEs) occurred in 59 patients (69.4%) in the pooled AND017 group and 18 patients (64.3%) in the placebo group; the treatment-related TEAEs occurred in 10 patients (11.8%) in the pooled AND017 group and 1 patient (3.6%) in the placebo group. A total of six patients, three in AND017 12 mg group and three in AND017 16 mg group, experienced serious AEs (SAEs), none of which were assessed as treatment related. The MN-201 anemia in NDD-CKD trial demonstrated that AND017 was safe and well tolerated in NDD-CKD patients with safety prolife similar to the placebo; the drug effectively increased the Hb level in a dose-dependent manner starting at 8 mg TIW within the first 5-week fixed-dose period. The Hb levels were maintained within the target range 10.0-11.0 g/dL at both TIW and QW dosing groups in the following 8-week titration period. The MN-202 trial is a phase II, randomized, open-label, active-controlled study to treat anemia in patients with dialysis-dependent with end-stage kidney disease (ESKD) in both U.S. and China. Eligible patients were randomized at a ratio of 1:1:1 to AND017 10 mg TIW group (59 pts), AND017 16 mg QW group (56 pts), and the active comparator erythropoietin stimulating agents (ESA) group (59 pts) and patients were treated for a total of 20-week study treatment with doses of AND017 adjusted based on the study protocol and doses of ESA adjusted based on the local package insert or clinical practice to target Hb ranges within 11.0-11.0 g/dL in U.S. and 10.0-12.0 g/dL in China. In the primary efficacy analysis, both AND017 10 mg TIW and 16 mg QW groups showed non-inferiority to ESA in the maintaining Hb levels within the target range during the 20-week treatment. For the safety assessment, treatment emergent adverse events (TEAEs) occurred in 91 patients (78.4%) treated with AND017 and 39 patients (66.1%) treated with ESA. Among all frequently reported TREAEs, the only TEAE deemed treatment-related was hyperkalemia (1 patient, 1.7% from the AND017 10 mg TIW group); other treatment-related TEAEs were all <5% and occurred in no more than 2 patients in the pooled AND017 or ESA groups. A total of 48 patients experienced SAEs, with 35 patients (30.2%) treated with AND017 and 13 patients (22.0%) treated with ESA; none were assessed as treatment related. Both TIW and QW dosing regimens of AND017 effectively maintained Hb levels after 20 weeks of treatment in ESA-treated dialysis-dependent ESKD patients and demonstrated non-inferiority to ESA treatment with a favorable safety profile. "AND017 demonstrated adequate safety and effectively increased and maintained hemoglobin levels in the 10.0-11.0 g/dL range in two Phase II studies involving both NDD and DD CKD patient populations. Efficacy and safety will be further assessed in Phase III trials," said Pablo E. Pergola, MD, Ph.D., an expert in nephrology and the director of the Clinical Advancement Center, PLLC, a wholly-owned subsidiary of Renal Associates. "We are excited about the overall PK, efficacy and safety profiles of our compound; our results provided a once weekly, longer interval dosing option in the same class of drugs," Qi Zhu, MD, the CMO of Kind Pharmaceutical. "The longer interval dosing could be one of the keys to mitigate MACE issue, which plagued the previous clinical trials for anemia in NDD CKD. We are willing to tackle this tough problem in phase III trials." The summary of the results from the four clinical trials presented at ANS is shown below; for more detail, please read the posters from Kind's website. Last week FDA granted Orphan Drug Designation to this investigation drug in Sickle Cell Disease (SCD) treatment. About Anemia in Chronic Kidney Disease Chronic kidney disease (CKD) is very common in general population; the prevalence for CKD in the United States is about 14% in adults and that in China is about 8%. Anemia is a common complication in chronic kidney disease. There are about half million dialysis-dependent CKD anemia patients and about five million non-dialysis-dependent CKD anemia patients in US; it is estimated there are about 700K DD CKD anemia patients and about 50 million NDD CKD anemia patients in China. Anemia in CKD can increase the risk of cardiovascular complications, such as heart failure and stroke, and increase morbidity and mortality. About AND017 AND017 is a first-in-class hemoglobin elevating agent (HbEA) that targets multiple stages of the red blood cell (RBC) life cycle and is being developed to treat anemia associated with dialysis-dependent chronic kidney disease (DD-CKD), non-dialysis dependent chronic kidney disease (NDD-CKD), cancer-related anemia (CRA), myelodysplastic syndromes (MDS) anemia, sickle cell disease (SCD), and β-thalassemia. About Kind Pharmaceutical ("Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC") KIND is a clinical-stage biopharmaceutical company focused on developing innovative medicines to treat hematological diseases and cancers. The company's mission, "kind to human, humble to science, good to patients", drives its commitment to advancing current science to meet unmet medical need. KIND's lead clinical candidate, AND017, first-in-class hemoglobin elevating agent (HbEA), is being developed for treating anemia of various disorders, including dialysis dependent chronic kidney disease (DD-CKD) associated anemia, non-dialysis dependent (NDD) CKD associated anemia, cancer related anemia (CRA), myelodysplastic syndromes (MDS) anemia, sickle cell disease (SCD), and β-thalassemia. KIND's second clinical candidate, AND019, an orally available brain penetrant selective estrogen receptor degrader (SERD), is being developed to treat ER+/Her2- breast cancer. KIND is also developing promising disruptive next generation ADC technologies. For details, please visit . Contact: Dong Liu, PhD, Chairman and CEO of Kind Pharmaceutical Email: [email protected] Tel: 650-315 6151 SOURCE Kind Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

– ATEV™ demonstrated superiority at six and 12 months (co-primary endpoints) compared to autogenous fistula, the current standard of care for hemodialysis access – - ATEV also showed superior function and patency in female, obese and diabetic patients, subgroups with historically poor outcomes with autogenous fistula procedures - DURHAM, N.C., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced the presentation of positive results from the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV) in arteriovenous (AV) access for patients with end-stage renal disease at the American Society of Nephrology’s (ASN) Kidney Week 2024, the premier nephrology meeting, in San Diego. In the Phase 3 trial, the ATEV demonstrated superior function and patency at six and 12 months (co-primary endpoints) compared to autogenous fistula, which is the current standard of care for hemodialysis patients, and also showed superior function and patency in female, obese and diabetic patients, each of which is a high-need subgroup with historically poor outcomes with AV fistula procedures. The late-breaking podium presentation, titled “Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access,” was presented on Saturday, October 26, 2024 by Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS, Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at the Center for Surgery and Public Health, and Assistant Professor of Surgery at Harvard Medical School. “These results show that availability of the ATEV, a biologic conduit, could be game changing in improving arteriovenous access in many hemodialysis patients,” said Dr. Hussain. “I was particularly pleased to see positive results in female, obese, and diabetic patients, groups which typically have poor outcomes with autogenous fistula procedures and historically limited treatment alternatives for hemodialysis access. The significantly higher duration of access over one year in these underserved patients could greatly reduce reliance on catheters for arteriovenous access.” The V007 Phase 3 trial (NCT03183245) is a prospective, multi-center, randomized clinical study in 242 hemodialysis patients in the United States. Enrolled individuals were randomly assigned to receive either the ​​ATEV or an AV fistula for hemodialysis access and are being followed for up to 24 months. Under the statistical analysis plan for the trial, the primary efficacy assessment compared functional patency (usability for hemodialysis access) at six months and secondary patency (blood flow through the conduit) at 12 months, as co-primary endpoints. At six months, 81.3% of the patients implanted with the ATEV had functional patency compared to 66.4% of the patients receiving an AV fistula. At 12 months, 68.3% of the patients implanted with the ATEV had secondary patency, compared to 62.2% of the patients receiving an AV fistula. The joint test for superiority of the ATEV versus AV fistula at six and 12 months was statistically significant (p=0.0071). Patients receiving an ATEV also achieved a significantly longer duration of hemodialysis over the first 12 months, as compared to AV fistula (p=0.0162). Sub-group analysis was also performed in patient groups that historically have poor outcomes with AV fistula procedures. In female patients (n=70), patients implanted with the ATEV had significantly higher six-month and one-year patency rates than female patients receiving an AV fistula (p<0.0001). Female patients receiving an ATEV also achieved a significantly longer duration of hemodialysis over the first 12 months compared to AV fistula, 8.3 months versus 5.0 months, respectively (p=0.0011). In obese patients (body mass index or BMI of at least 30) (n=93), patients implanted with the ATEV had significantly higher six-month and one-year patency rates than diabetic patients receiving an AV fistula (p=0.0001). Obese patients receiving an ATEV also achieved a significantly longer duration of hemodialysis over the first 12 months compared to AV fistula, 7.7 months versus 4.5 months, respectively (p=0.0020). In diabetic patients (n=165), patients implanted with the ATEV had significantly higher six-month and one-year patency rates than diabetic patients receiving an AV fistula (p=0.0024). Diabetic patients receiving an ATEV also achieved a significantly longer duration of hemodialysis over the first 12 months compared to AV fistula, 7.4 months versus 5.5 months, respectively (p=0.0155). Rates of infection were low in both treatment arms, with 9.1% of patients implanted with the ATEV experiencing access-related infections (12 total events) compared to 9.9% of patients treated with AV fistula (14 total events). Treatment-Emergent Adverse Events (TAEEs) occurred in 98.3% of patients implanted with the ATEV (1,211 total events) compared to 96.7% of patients treated with AV fistula (828 total events). The largest area of difference in adverse events was in thrombosis, occurring in 52.1% of patients implanted with the ATEV (126 total events) compared to 9.1% of patients treated with AV fistula (12 total events). The majority of ATEV patients with thrombosis, 94%, were successfully treated. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. Humacyte develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication is currently under review by the FDA and was granted Priority Review. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEV; our ability to successfully complete preclinical and clinical trials for our ATEVs; the anticipated benefits of the our ATEVs relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances, and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in subsequent SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com