Atherosclerosis

Initiated pivotal spiriTED Phase 2b trial in Thyroid Eye Disease (TED) in 2023 and expanded TED clinical development plan, including accelerating the planned initiation of a pivotal Phase 3 trial into 2024 Reached alignment with the U.S. FDA on the clinical development program in Atherosclerotic Cardiovascular Disease (ASCVD) in 2023 and received clearance for Investigational New Drug application (IND) in March 2024 Completed reverse merger with Talaris Therapeutics in October 2023, including a concurrent private placement of $75.0 million Completed underwritten follow-on public offering in January 2024, raising gross proceeds of $172.5 million Expected cash runway into 2027, providing funding for key TOUR006 data readouts in TED and cardiovascular disease and the opportunity to expand into additional indications NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today announced its financial results for the fourth quarter and year ended December 31, 2023 and outlined recent business highlights. “2023 was a transformational year for Tourmaline. We became a public company and continued our efforts to lead an IL-6 renaissance with TOUR006, which we believe can achieve a best-in-class pro providing a long-acting, patient-friendly treatment through low-volume subcutaneous injections,” said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. “With the support of our expanding team, the clinical and patient communities, and our shareholders, we look forward to executing on our two strategic paths. We aim to harness the exciting and emerging insights in the IL-6 field towards addressing significant unmet medical needs in TED, ASCVD, and other autoantibody and inflammation-driven diseases.” Clinical Highlights and Upcoming Milestones: Tourmaline is pursuing development of TOUR006 in two areas of high unmet need: FcRn+ and cardiovascular inflammation. FcRn+ Tourmaline believes that TOUR006, a long-acting, fully-human, anti-IL-6 monoclonal antibody, can potentially deliver substantial therapeutic benefit to address a wide range of autoantibody-driven disorders, including a more durable response and patient-friendly administration than therapies currently on the market or in clinical development by others. The pivotal spiriTED Phase 2b trial in TED is currently enrolling, and Tourmaline continues to expect topline data in the first half of 2025. Tourmaline plans to accelerate the initiation of a pivotal Phase 3 trial evaluating subcutaneous TOUR006 every 8 weeks as first-line treatment for TED in 2024, with topline data expected in 2026. Tourmaline continues to explore additional indications with significant unmet medical need under its FcRn+ strategic path. Cardiovascular Inflammation During 2023, Tourmaline reached alignment with the U.S. Food and Drug Administration (FDA) on the clinical development program of TOUR006 in ASCVD, and Tourmaline received clearance for the related IND in March 2024. Tourmaline plans to commence a Phase 2 trial evaluating quarterly subcutaneous dosing of TOUR006 in patients with elevated cardiovascular risk in the first half of 2024. Data from this Phase 2 trial are expected in the first half of 2025. Other Corporate Highlights: In October 2023, Tourmaline become a publicly-traded company via reverse merger with Talaris Therapeutics, including a concurrent private placement of $75.0 million. In December 2023, Tourmaline expanded its Board of Directors with the appointment of Dr. Clay Siegall as Chairman. Tourmaline also continued to expand its executive leadership team during 2023, including the appointments of Gerhard Hagn as SVP, Head of Commercial and Business Development and Dr. Emil deGoma as SVP, Medical Research. In December 2023, Tourmaline was added to the NASDAQ Biotechnology Index (NASDAQ: NBI). In January 2024, Tourmaline completed an underwritten follow-on public offering of its common stock, which included the full exercise of the underwriters' option to purchase additional shares, resulting in gross proceeds of $172.5 million. Net proceeds were $161.3 million after deducting underwriting discounts and offering expenses. Fourth Quarter and Full Year 2023 Financial Results: Cash Position Cash, cash equivalents and investments were $203.0 million as of December 31, 2023, as compared to $8.3 million as of December 31, 2022. Tourmaline anticipates that its current cash, cash equivalents and investments as of the date hereof, which includes $161.3 million of net proceeds received from the January 2024 underwritten public offering, will provide cash runway into 2027, funding key TOUR006 data readouts in TED and cardiovascular disease and the opportunity to expand development efforts into additional indications. Research and Development Expenses Research and development expenses were $8.0 million for the fourth quarter of 2023, as compared to $3.8 million for the fourth quarter of 2022. Research and development expenses were $32.4 million for the full year ended December 31, 2023, as compared to $17.5 million for the full year ended December 31, 2022. The increase in research and development expenses for both periods was primarily driven by employee compensation costs attributable to increased headcount, costs associated with the manufacture of drug substance and drug product for Tourmaline’s clinical trials, and clinical trial costs related to the spiriTED trial. General and Administrative Expenses General and administrative expenses were $6.9 million for the fourth quarter of 2023, as compared to $1.1 million for the fourth quarter of 2022. General and administrative expenses were $13.0 million for the full year ended December 31, 2023, as compared to $2.2 million for the full year ended December 31, 2022. The increase in general and administrative expenses for both periods was primarily driven by employee compensation costs attributable to increased headcount, increased recruiting and commercial consulting expenses, and increased professional service fees. Net Loss Net loss was $12.9 million for the fourth quarter of 2023 and $4.9 million for the fourth quarter of 2022, resulting in basic and diluted net loss per share of $0.81 and $5.51, respectively. Net loss was $42.1 million for the full year ended December 31, 2023 and $19.7 million for the full year ended December 31, 2022, resulting in basic and diluted net loss per share of $8.87 and $22.46, respectively. The increase in net loss for both periods was attributable to increased operating expenses and the overall growth of Tourmaline during 2023 as compared to 2022. The decrease in net loss per share for both periods was attributable to the issuance of additional shares of common stock in conjunction with the reverse merger and private placement that were completed in October 2023. About Tourmaline Bio: Tourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Tourmaline’s lead asset is TOUR006. About TOUR006: TOUR006 is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. To date, TOUR006 has been studied in 448 participants, including patients with autoimmune disorders, across six clinical trials. Tourmaline is developing TOUR006 in TED and ASCVD as its first two indications, with additional diseases under consideration. Cautionary Note Regarding Forward-Looking Statements: Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe,” “designed to,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Tourmaline’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of TOUR006; the timing of initiation, progress and results of Tourmaline’s current and future clinical trials for TOUR006, including reporting of data therefrom; the timing and potential of preclinical research and development activities; market opportunities; and Tourmaline’s anticipated cash runway. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Tourmaline’s current or future product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Tourmaline’s current or future product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Tourmaline’s current or future product candidates; the risk that Tourmaline’s current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy pro Tourmaline anticipates; risks regarding the accuracy of Tourmaline’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions Tourmaline’s business, clinical trials and financial position; and other risks and uncertainties that are described in Tourmaline’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on or about March 19, 2024 and other filings that Tourmaline makes with the SEC from time to time. Any forward-looking statements speak only as of the date of this press release and are based on information available to Tourmaline as of the date hereof, and Tourmaline assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Tourmaline Bio, Inc. Consolidated Statements of Operations (unaudited) (amounts in thousands, except per share data) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Operating expenses: Research and development $ 8,015 $ 3,794 $ 32,368 $ 17,526 General and administrative 6,875 1,126 13,041 2,175 Total operating expenses 14,890 4,920 45,409 19,701 Loss from operations (14,890 ) (4,920 ) (45,409 ) (19,701 ) Other income, net 1,988 — 3,285 — Net loss $ (12,902 ) $ (4,920 ) $ (42,124 ) $ (19,701 ) Net loss per share, basic and diluted $ (0.81 ) $ (5.51 ) $ (8.87 ) $ (22.46 ) Weighted-average common shares outstanding, basic and diluted 16,003 893 4,747 877 Tourmaline Bio, Inc. Selected Consolidated Balance Sheet Data (unaudited) (amounts in thousands) December 31, 2023 2022 Cash, cash equivalents and investments $ 202,951 $ 8,258 Working capital $ 203,872 $ 6,949 Total assets $ 210,295 $ 9,098 Total stockholders’ equity (deficit) $ 205,042 $ (19,732 ) Investor Contact: Meru Advisors Lee M. Stern lstern@meruadvisors.com

- Application based on integrated global data dossier completed for Lerodalcibep by LIB - Hasten to begin bridging studies to support planned BLA submission in China CINCINNATI--(BUSINESS WIRE)-- LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. In September 2023, LIB announced that it had entered into an agreement granting Hasten the rights to develop and commercialize Lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan) and will be responsible for clinical development and regulatory approval in these territories. The acceptance of the Lerodalcibep clinical trial application by the NMPA was based on the integrated data dossier provided by LIB, including CMC, non-clinical and clinical studies completed in the U.S., Europe, and rest of world as well as the clinical development plan in China proposed by Hasten. “We are excited for Hasten to begin the bridging studies necessary to seek approval and to bring Lerodalcibep to a large and growing population in China with CVD who need substantial additional LDL-C reductions, despite being on statin therapy,” said David Cory, Chief Executive Officer of LIB. “We are preparing our own Lerodalcibep BLA submission to the FDA, to be followed by MAA submission to EMA. Lerodalcibep has a potential best in class LDL-C lowering pro will be differentiated as a more patient-friendly, once-monthly, small-volume, single subcutaneous injection that will not require refrigeration at home or in travel.” About Lerodalcibep Lerodalcibep is a potential best in class, novel, small binding protein, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly dose in a small injection volume and with long-ambient stability. Combined with sustained LDL-C reductions demonstrated in clinical trials, Lerodalcibep is expected to expand treatment options for the millions of patients around the world with atherosclerotic cardiovascular disease (ASCVD), and those at very high and high risk for ASCVD, including the 30 million individuals with more severe inherited high-cholesterol called familial hypercholesterolemia (FH). The global Phase 3 LIBerate program with over 2,700 patients enrolled a diverse population of patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia (FH). Key registration placebo-controlled trials included Lerodalcibep once-monthly for up to 52 weeks, and over 2,400 patients continued in the 72-week open-label extension trial. LIB is preparing a biologics license application (BLA) for submission to the Food and Drug Administration followed by a marketing authorization application (MAA) for submission to the European Medicines Agency. About Hasten Biopharmaceutical Company, Ltd. Hasten Biopharmaceutical Co., Ltd., which integrates R&D, production and commercial promotion and covers the whole industrial chain, was established in 2020. Hasten is committed to becoming a leader in the healthcare industry. Through joining hands with the stakeholders such as relevant government institutions, medical and health professionals and industry partners, Hasten provides high-quality medicines and solutions to benefit patients and create social value. About LIB Therapeutics, Inc. LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing novel, safe and convenient subcutaneous and oral PCSK9 inhibitors to the millions of patients with cardiovascular disease and the 30 million individuals with familial hypercholesterolemia (FH), who require additional large reductions in low density lipoprotein-cholesterol (LDL-C) despite maximally tolerated statins and other lipid lowering agents. For more information, please visit: .

DURHAM, N.C., March 18, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the fourth quarter and year ended December 31, 2023, on Friday, March 22, 2024. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update. Title:Humacyte Fourth Quarter and Year-End 2024 Earnings Conference CallDate:March 22, 2024Time8:00 AM Eastern TimeConference Call Details1-877-704-4453 (U.S. Investors Dial)1-201-389-0920 (International Investors Dial)13744046 (Conference ID)Call meTMFeatureClick HereWebcastWebcast Link - Click Here The webcast should be accessible 15 minutes prior to the conference call’s start time. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days. 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 initial opportunity, a portfolio of HAVs, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial 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 HAV 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 HAV for urgent arterial repair following extremity vascular trauma also has received RMAT designation. The HAV 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, statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our HAVs; our ability to successfully complete, preclinical and clinical trials for our HAVs; the anticipated benefits of our HAVs relative to existing alternatives; the anticipated commercialization of our HAVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; the timing or likelihood of regulatory filings and approvals; timing, scope, and rate of reimbursement for our HAVs; the outcome of our ongoing discussions with the FDA concerning the design of our ongoing V005 Phase 2/3 clinical trial, including determination of trial size, and the scope of any approved indication for our HAVs; and our estimated available market opportunity. 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 included under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, filed by Humacyte with the SEC and in future 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