IL-6

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

PRINCETON, NJ / ACCESSWIRE / March 19, 2024 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today that preclinical data and clinical trial design from the study of SON-080 (recombinant human Interleukin-6 or rhIL-6) in CIPN will be presented in a poster session at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, to be held April 5-10, in San Diego, California. Presentation details: Title: Low dose interleukin-6 (SON-080) for neuropathies: Toxicology and clinical plans Session Title: Pharmacology and Pharmacogenetics Presentation Type: Poster Session Date and Time: Wednesday April 10, 2024, 9:00 AM - 12:30 PM Abstract Number: 7181 Location: Poster Section 24 Poster Board Number: 22 About Sonnet BioTherapeutics Holdings, Inc. Sonnet BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovating biologic drugs of single or bifunctional action. Known as FHAB (Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. Sonnet's FHAB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs. FHAB is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies, and vaccines. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's cash runway, the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Sonnet BioTherapeutics Investor Contact: Jack Yauch Solebury Strategic Communications 862-754-1024 jyauch@soleburystrat.com SOURCE: Sonnet BioTherapeutics, Inc. View the original press release on accesswire.com

British Medical Journal Open publishes paper detailing the results of the international Phase II human trial for LSALT peptide targeting acute lung and kidney inflammation in hospitalized patients infected with SARS-CoV-2 virusPhase II findings previously disclosed support dipeptidase-1 (DPEP-1) as a relevant therapeutic target for diseases of the lung, kidneys and liver where inflammation plays a major role. New biomarker data from the pandemic Phase II trial, provides further scientific rationale for Arch to bring LSALT peptide into larger trials to inhibit DPEP-1 mediated organ inflammation. Arch is currently performing a Phase II human trial to support LSALT peptide as a first ever treatment for preventing cardiac surgery-associated acute kidney injury. TORONTO, March 18, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has published a peer reviewed paper in the British Medical Journal Open (BMJ Open) detailing the results of the international Phase II human trial for LSALT peptide targeting acute lung and kidney inflammation in hospitalized patients infected with SARS-CoV-2 virus. LSALT peptide is a DPEP-1 inhibitor and the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs, and liver. The paper in BMJ Open describes the clinical highlights, outcomes and biomarker results of the study. The Phase II trial was an international, multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide for the prevention of organ inflammation such as acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in patients infected with SARS-CoV-2. The exploratory, adaptive trial was initiated in the early stages of the global pandemic to identify clinical signals of efficacy for LSALT peptide in the treatment of acute lung and kidney inflammation. The results of the Phase II trial provided first-ever evidence validating DPEP-1 as a mediator of organ inflammation and therapeutic target in humans. In addition, LSALT peptide was well tolerated with no safety issues related to the drug. New biomarker data for LSALT peptide was disclosed for the first time in the BMJ Open publication. An analysis of serum inflammatory biomarkers was performed from blood samples collected from study participants. Biomarkers analyzed which relate to organ inflammation included cytokines and chemokines such as IL-6, CXCL8, CXCL10, IL-1β and CCL7. Collectively, a greater proportion of inflammatory biomarkers decreased in patients receiving LSALT peptide compared with placebo. In particular, the reduction of CXCL10 in the LSALT peptide group versus the placebo group was statistically significant at the end of treatment. CXCL10 plays a role in facilitating leukocyte recruitment to various vascular beds including the lungs and kidneys. The reduction of CXCL10 and the other inflammatory biomarkers during LSALT peptide treatment is consistent with LSALT peptide’s mechanism of action as an inhibitor of DPEP-1 mediated leukocyte recruitment to the lungs and kidneys. The new data provides more scientific rationale for Arch to advance LSALT peptide to prevent leukocyte recruitment and organ inflammation for other indications, including a larger Phase II trial targeting cardiac surgery-associated AKI, which recently began recruiting patients. More information on the current trial can be found below and at clinicaltrials.gov Details of the results from the Phase II trial are reported in the peer-reviewed journal BMJ Open. The publication, titled “Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome and Acute Kidney Injury in Patients Infected with SARS-CoV-2 (COVID-19)” by Somayaji et. al. can be found at the BMJ Open website. Quote from Richard Muruve, CEO of Arch Biopartners Inc.: “When the pandemic started and hospitals were filling up with patients with respiratory distress caused by inflammation, we postponed our plans to do a CS-AKI trial to urgently perform a Phase II trial to treat hospitalized COVID patients and reduce acute organ inflammation. Now that we have published our biomarker and clinical data from the trial, we are more confident today that inhibiting DPEP-1 mediated leukocyte recruitment to the kidneys, lungs and liver is a valid path toward first-ever treatments to prevent acute injury in these organs.” About the Phase II trial for LSALT Peptide in Pandemic Patients The Phase II trial was an international, multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide for the prevention of organ inflammation such as acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in patients infected with SARS-CoV-2. Six clinical sites located in Canada, United States, and Turkey participated in the Phase II trial in 2021. The composite primary endpoint of the Phase II trial reflected the severe effects often experienced by hospitalized patients in the early months of the pandemic and deemed appropriate for LSALT peptide’s novel mechanism of action in blocking consequential inflammation in the lungs, kidneys, and other organs. The exploratory study was designed to detect a clinical signal of efficacy and was not powered for statistical significance. Previously disclosed in December 2021 and included in the BMJ Open publication, there were no significant differences in adverse events between LSALT peptide and placebo treated patients. The study population of the Phase II trial did not have enough incidence of ARDS or AKI to detect a conclusion on these two particular clinical outcomes. In a secondary evaluation of patients on ventilation, despite being older by an average of 5 years, subjects in the LSALT peptide group demonstrated 22.8 ventilation-free days compared to 20.9 days in the placebo group in the unadjusted analysis at 28 days. “Ventilation” was defined as a need for high flow oxygen therapy (≥ 6L/min), non-invasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a post-hoc analysis adjusting for age, body mass index (BMI), and PaO2/FiO2 ratio (a measure of lung disease severity), the difference in ventilation-free days was 6.7 days favoring the LSALT peptide group compared to the placebo group. About Phase II trial for LSALT Peptide targeting CS-AKI Arch Biopartners is currently sponsoring a Phase II trial for LSALT peptide targeting cardiac surgery-associated acute kidney injury (CS-AKI). CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI. The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide. The recruitment target for the trial is 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with AKI within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Details of the Phase II trial, entitled “Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery” can be viewed at clinicaltrials.gov. Recruitment of patients in the CS-AKI trial has begun in three hospital sites in Turkey with a hospital in Canada (University of Calgary) joining the trial last week. Additional sites are expected to be added in Turkey and Canada in the next few weeks. About LSALT Peptide LSALT peptide is a novel peptide drug candidate and DPEP-1 inhibitor. In August 2019, a scientific team led by Arch scientists Dr. Donna Senger and Dr. Stephen Robbins published a paper in the journal Cell describing a novel mechanism of action for organ inflammation. In the publication, DPEP-1 was identified, for the first time, as a major leukocyte (white blood cell) adhesion receptor on the lung, liver and kidney endothelium. DPEP-1 was also identified as the target of LSALT peptide, differing from typical anti-inflammatory drugs by targeting this novel adhesion receptor rather than targeting individual cytokines, of which there are many. The Cell publication, titled “Dipeptidase-1 is an adhesion receptor for neutrophil recruitment in lungs and liver” by Choudhry et. Al. can be found at the Cell journal’s website. LSALT peptide has been shown by Arch scientists and their collaborators to prevent ischemia-reperfusion injury to the kidneys in pre-clinical models (Video Link to pre-clinical proof of concept). Details of their findings were published in a Science Advances publication, titled “Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury” by Lau et. al. and can be found at the Science Advances website. About Arch Biopartners Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The Company is developing new drug candidates that inhibit inflammation in the lungs, kidneys, and liver via the dipeptidase-1 (DPEP-1) pathway and are relevant for common injuries and diseases where organ inflammation is an unmet problem. For more information on Arch Biopartners' science and technologies, please visit: www.archbiopartners.com/our-science For investor information and other public documents the company has also filed on SEDAR+, please visit www.archbiopartners.com/investor-hub The Company has 62,755,633 common shares outstanding. Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of our future performance, liquidity and capital resources, as well as the ongoing clinical development of our drug candidates targeting the dipeptidase-1 (DPEP-1) pathway, including the outcome of our clinical trials relating to LSALT peptide (Metablok), the successful commercialization and marketing of our drug candidates, whether we will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe and other countries, our ability to raise capital to fund our business plans, the efficacy of our drug candidates compared to the drug candidates developed by our competitors, our ability to retain and attract key management personnel, and the breadth of, and our ability to protect, our intellectual property portfolio. These statements are based on management’s current expectations and beliefs, including certain factors and assumptions, as described in our most recent annual audited financial statements and related management discussion and analysis under the heading “Business Risks and Uncertainties”. As a result of these risks and uncertainties, or other unknown risks and uncertainties, our actual results may differ materially from those contained in any forward-looking statements. The words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We undertake no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including our most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (“SEDAR”) website at www.sedarplus.ca . The science and medical contents of this release have been approved by the Company’s Chief Science Officer Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release