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DURHAM, N.C.and SEATTLE, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, and Pluristyx, Inc. today announced an expanded partnership. Pluristyx makes and sells PluriBank™ iPSC lines as part of their tools, technologies, and services to support the development of cellular therapies, and is currently performing gene editing of PluriBank cells for Humacyte’s use in developing its investigational BioVascular Pancreas (BVP™), designed for the potential treatment of insulin-dependent diabetes. Pluristyx has developed a clinical-grade manufacturing process for using a licensed Mad7 gene editing technology to block Human Leukocyte Antigen (HLA) markers expression. Humacyte is optimizing a process to differentiate immune-evading iPSCs, provided by Pluristyx, into a pancreatic islet component of their BVP that will aim to normalize glucose levels in diabetic patients. The expanded partnership builds on Humacyte’s existing license for Pluristyx’s PluriBank cell lines. “We are excited to grow our pipeline by advancing the development of the BVP, an advanced tissue and organ system,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “The stem cell and gene editing technologies from Pluristyx have promising advantages for our BioVascular Pancreas and other cell and tissue therapies.” “The recent FDA approval for Humacyte’s Symvess™ (acellular tissue engineered vessel) for use as a vascular conduit for extremity arterial injury is a huge step forward to treating trauma patients,” said Benjamin Fryer, Ph.D., co-Founder and Chief Executive Officer of Pluristyx. “Pluristyx is proud to support Humacyte as they develop the BioVascular Pancreas, a highly needed organ system for the treatment of insulin-dependent diabetes.” The BVP is designed to enable the delivery and survival of insulin-producing islets inside the body, using Humacyte’s acellular tissue engineered vessel (ATEV™) as a carrier for the islets. The BVP is an investigational product in pre-clinical development and has not been approved for sale by the Food and Drug Administration or any global regulatory agency. About Pluristyx Pluristyx is a privately held, biotechnology company offering a wide range of products and services to support the development and manufacture of cell and gene therapies, including iPSC lines, proprietary genetic engineering technologies, differentiation services, iPSC culture kits, and contract development services. Pluristyx is committed to delivering highest quality products and services to accelerate clinical translation of life-changing cell therapies. For more information on Pluristyx visit www.pluristyx.com. 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. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease. 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 uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. For more information, visit www.Humacyte.com. Humacyte 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 and the BVP; the anticipated benefits of the our BVPs relative to existing alternatives; the expected success of our sales team; the validity of our Budget Impact Model; 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 Pluristyx Contact:Steve Geelhood+1 888-588-9935 Business DevelopmentEmail: info@pluristyx.com

- Following the recent submission of the IND application for CNTY-101 and pending FDA clearance, the Phase 1 ELiPSE-1 trial in relapsed/refractory lymphoma is on track to commence in the second half of 2022 - - Ended second quarter 2022 with cash, cash equivalents, and investments of $429.4; Expected cash runway into 2025 - PHILADELPHIA, Aug. 11, 2022 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, today reported financial results and business highlights for the second quarter ended June 30, 2022. “We are excited about our recent IND submission for our lead candidate, CNTY-101, and pending FDA clearance, are looking forward to initiating the Phase 1 ELiPSE-1 trial in relapsed/refractory lymphoma,” said Lalo Flores, Chief Executive Officer, Century Therapeutics. “We continue to make steady progress in building a best-in-class allogeneic cell therapy platform and achieved a key milestone this quarter in establishing the iNK 3.0 Common Progenitor, which we believe will accelerate new candidate selection. Additionally, we look forward to providing updates on our gamma delta iT platform and other program advancements in the coming months.” Business Highlights The Company presented preclinical data on MAD7, a novel CRISPR nuclease used to enable the genetic engineering of iPSC-derived NK and T cell product candidates, during a poster presentation at the American Society of Gene and Cell Therapy (ASGCT) 25th Annual Meeting held on May 16-19, 2022 in Washington, D.C. A copy of the presentation is available in the Posters section of Century’s website.During a Research and Development Event in June, Century’s management team discussed CNTY-103, the Company’s first solid tumor candidate for glioblastoma, the establishment of the Common Progenitor iNK 3.0, and progress on the Company’s next-generation iPSC-based cell therapy platform. Century expects to submit an Investigational New Drug (IND) application for CNTY-103 in 2024.The Company’s current Good Manufacturing Practice (cGMP) manufacturing facility in Branchburg, New Jersey is operational and undergoing qualification.Century was added to the Russell Microcap Index in June 2022. Subsequent Events and Upcoming Milestones Following the recent submission of the IND application for CNTY-101, the Company remains on track to initiate its Phase 1 ELiPSE-1 clinical trial in the second half of 2022, subject to U.S. Food and Drug Administration (FDA) clearance of the application. ELiPSE-1 will assess CNTY-101 in patients with relapsed/refractory CD19 positive aggressive lymphoma or indolent lymphoma after at least two prior lines of therapy, including patients who have received prior CAR-T cell therapy. Second Quarter 2022 Financial Results Cash Position: Cash, cash equivalents, and investments were $429.4 million as of June 30, 2022, as compared to $358.8 million as of December 31, 2021. Net cash provided by operations was $61.2 million for the six months ended June 30, 2022 (which includes deferred revenue from the Bristol-Myers Squibb (BMS) collaboration of $120.7M) compared to net cash used in operations of $40.7 million for the six months ended June 30, 2021.Collaboration Revenue: Collaboration revenue was $1.4 million for the three months ended June 30, 2022, generated through the Company’s collaboration, option and license agreement with BMS.Research and Development (R&D) expenses: R&D expenses were $24.5 million for the three months ended June 30, 2022, compared to $18.9 million for the same period in 2021. The increase in R&D expenses was primarily due to an increase in personnel expenses related to increased headcount to expand the Company’s R&D capabilities, costs for pre-clinical studies, costs for laboratory supplies and facility costs, offset by a decrease in collaboration expenses with FUJIFILM Cellular Dynamics, Inc. (FCDI) as the scope of work with FCDI has narrowed down to primarily manufacturing CNTY-101 clinical supply.General and Administrative (G&A) expenses: G&A expenses were $8.3 million for the three months ended June 30, 2022, compared to $4.1 million for the same period in 2021. The increase was primarily due to an increase in employee headcount, an increase in directors’ and officers’ insurance expense and an increase in the Company’s professional fees as a result of expanded operations to support the Company’s infrastructure as well as additional costs to operate as a public company, and increased information technology and facility costs.Net loss: Net loss was $31.0 million for the three months ended June 30, 2022, compared to $23.3 million for the same period in 2021. Financial Guidance The Company expects full year GAAP Operating Expenses to be between $155 million and $165 million including non-cash stock-based compensation expense of $10 million to $15 million.The Company expects its cash, cash equivalents, and investments will support operations into 2025. About Century Therapeutics Century Therapeutics, Inc. (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived iNK and iT cell product candidates are designed to specifically target hematologic and solid tumor cancers. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care. For more information on Century Therapeutics please visit https://www.centurytx.com/. Forward-Looking Statements This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our cash, financial resources, and estimated expenses, our clinical development plans and timelines, and the development of our U.S. manufacturing facility are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this presentation are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our ability to obtain FDA acceptance for our IND submissions and commence clinical trials on expected timelines, or at all; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of the COVID-19 pandemic, geopolitical issues and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our future clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. For More Information: Company: Elizabeth Krutoholow – investor.relations@centurytx.com Investors: Melissa Forst/Maghan Meyers – century@argotpartners.com Media: Joshua R. Mansbach – century@argotpartners.com Century Therapeutics, IncCondensed Balance Sheets(unaudited, in thousands) June 30, December 31,Assets 2022 2021Current Assets: $ $ Cash and cash equivalents 112,787 56,445 Short-term investments 265,971 166,434 Prepaid expenses and other current assets 5,035 5,275 Total current assets 383,793 228,154 Property and equipment, net 69,971 57,967 Operating lease right-of-use assets, net 24,728 11,854 Long-term investments 50,607 135,914 Other long-term assets 3,485 3,486 Total assets $532,584 $437,375 Liabilities, convertible preferred stock, and stockholders' equity Current liabilities: Accounts payable $4,048 $7,596 Accrued expenses and other liabilities 9,697 8,059 Deferred revenue, current 7,824 - Total current liabilities 21,569 15,655 Operating lease liability, noncurrent 30,433 14,559 Long-term debt, net 8,501 8,903 Other long-term liabilities 1,220 2,020 Deferred revenue 112,909 - Total liabilities 174,632 41,137 Stockholders' equity Common stock 6 5 Additional paid-in capital 818,047 785,049 Accumulated deficit (456,667) (388,166)Accumulated other comprehensive loss (3,434) (650)Total stockholders' equity 357,952 396,238 Total liabilities and stockholders' equity $532,584 $437,375 Century Therapeutics, IncCondensed consolidated statements of operations(unaudited, in thousands, except share and per share amounts) Three months ended Six months ended June 30, June 30, June 30, June 30, 2022 2021 2022 2021 Collaboration Revenue$1,396 $- $2,454 $- Operating Expenses Research and development$24,494 $18,933 $45,690 $34,307 General and administrative 8,253 4,088 15,551 6,776 In-process research and development - - 10,000 - Total operating expenses$32,747 $23,021 $71,241 $41,083 Loss from operations (31,351) (23,021) (68,787) (41,083) Interest expense (330) (318) (644) (632)Other income, net 711 66 964 94 Loss before provision for income taxes$(30,970) $(23,273) $(68,467) $(41,621)Provision for income taxes (18) - (34) - Net Loss$(30,988) $(23,273) $(68,501) $(41,621) Unrealized (loss) gain on investments (780) 32 (2,766) 5 Foreign currency translation adjustment (12) (9) (18) (5)Comprehensive loss (31,780) (23,250) (71,285) (41,621) Net loss per common share - Basic and Diluted (0.54) (1.93) (1.19) (4.26) Weighted average common shares outstanding 57,685,006 12,044,610 57,370,022 9,775,840