Renal Insufficiency

Company is advancing portfolio of novel therapies that aim to redefine the standard of care for patients with autoimmune diseases Lead candidate JADE-001 on track to enter the clinic in second half of 2025, with initial data expected in first half of 2026 The combined company will operate as “Jade Biosciences, Inc.” and will trade on Nasdaq under the ticker symbol “JBIO” April 28, 2025 -- Jade Biosciences, Inc. (“Jade” or the “Company”), a biotechnology company focused on developing best-in-class therapies for autoimmune diseases, today announced the completion of its previously announced merger with Aerovate Therapeutics, Inc. (“Aerovate”). The combined company will operate as Jade Biosciences, Inc., with its shares expected to begin trading on the Nasdaq Capital Market on April 29, 2025, under the ticker symbol “JBIO.” Immediately prior to the merger, Jade successfully completed a previously announced, oversubscribed private investment round that resulted in total gross proceeds of approximately $300 million from a syndicate of healthcare investors led by Fairmount, Venrock Healthcare Capital Partners, and a large investment firm, with participation from Deep Track Capital, Braidwell LP, Driehaus Capital Management, Frazier Life Sciences, RA Capital Management, Great Point Partners, Soleus Capital, Avidity Partners, Blackstone Multi-Asset Investing, Logos Capital, Deerfield Management, OrbiMed, and Samsara BioCapital, among other leading investment management firms. The proceeds include the conversion of $95 million in previously issued convertible notes, plus interest and premiums thereon. Pursuant to the terms of the previously disclosed merger agreement, each outstanding share of Jade common stock was converted into 0.6311 shares of common stock of the combined company, as adjusted for the reverse stock split of Aerovate common stock at a ratio of 1-for-35 shares, effected immediately prior to the merger. In the reverse stock split, every 35 shares of Aerovate common stock outstanding were combined and reclassified into 1 share of Aerovate common stock. The new CUSIP number for the combined company following the reverse stock split and merger is 008064206. In connection with the closing of the merger, Aerovate will distribute a previously announced special cash dividend of approximately $2.40 per share of common stock to pre-merger Aerovate stockholders of record as of April 25, 2025. Following completion of the reverse stock split, private placement, and merger, there are approximately 60.6 million shares of the combined company’s common stock outstanding on a fully-diluted basis, or approximately 52.6 million shares excluding shares underlying equity awards. “We’ve made remarkable progress since our founding, assembling a talented team with deep expertise in drug development for autoimmune diseases,” said Tom Frohlich, Chief Executive Officer of Jade. “With a strong financial foundation, we aim to advance best-in-class therapeutics for autoimmune diseases, offering more patient-friendly dosing regimens with the potential of better outcomes. Our lead program, JADE-001, is just one example that reflects our commitment to providing patients with better solutions.” JADE-001 is an investigational anti-A PRoliferation-Inducing Ligand (APRIL) monoclonal antibody for the treatment of Immunoglobulin A (IgA) nephropathy (IgAN), an autoimmune condition in which the kidney is damaged by pathogenic IgA containing immune complexes, leading to proteinuria and kidney function decline, and potentially progressing to end-stage kidney disease requiring dialysis or transplantation. Designed to block the APRIL protein, JADE-001 targets an underlying cause of IgAN, offering the potential to reduce pathogenic IgA levels, decrease proteinuria, and preserve kidney function over the long term. Incorporating half-life extension technology, JADE-001 is engineered to enable dosing at intervals of at least eight weeks, with the potential to significantly alleviate the burden of treatment, particularly considering that IgAN is often diagnosed in young adulthood and requires lifelong care. JADE-001 is anticipated to enter the clinic in the second half of 2025, with initial data expected in the first half of 2026. In addition, Jade has initiated preclinical development of JADE-002 and JADE-003, two undisclosed antibody programs. IgAN is a chronic autoimmune disease in which an abnormal form of IgA (a type of antibody produced by the body) is deposited in the kidney and causes kidney damage. Over time, kidney function can decline and may lead to kidney failure requiring dialysis or kidney transplant. IgAN is often diagnosed in young adulthood, and there are currently no approved treatments for IgAN that reduce the abnormal form of IgA and stabilize kidney function. APRIL, or “A Proliferation-Inducing Ligand,” is a protein in the body that is necessary for immune cells to make IgA antibodies. Too much APRIL can lead to the overproduction of IgA, including an abnormal IgA variant that can result in immune complex formation which can be harmful to the kidney. Jade Biosciences is focused on developing best-in-class therapies to address critical unmet needs in autoimmune diseases. Its lead asset, JADE-001, targets the cytokine APRIL for immunoglobulin A nephropathy, with initiation of a first-in-human clinical trial expected in the second half of 2025. Jade’s pipeline also includes two undisclosed antibody discovery programs, JADE-002 and JADE-003, currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. The content above comes from the network. if any infringement, please contact us to modify.

30-Day Data from Endospan's NEXUS TRIOMPHE IDE Trial Demonstrate 63% Reduction in Major Adverse Event (MAE) Rate compared with Reference Performance Goal ATLANTA, May 5, 2025 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced the presentation of new clinical data from Endospan's NEXUS TRIOMPHE trial at the 105th American Association for Thoracic Surgery (AATS) Annual Meeting in Seattle, Washington. The data presented analyzed clinical outcomes across a 54-patient chronic aortic dissection statistical cohort at 30 days following treatment with NEXUS. Patients enrolled were at high risk for open surgical repair. Dr. Bradley Leshnower, Professor of Surgery and Director of Thoracic Aortic Surgery, Emory University, presented the data from the NEXUS US IDE trial in an abstract titled, Endovascular Aortic Arch Repair Using a Novel Single-Branch Arch Stent Graft for Chronic Dissection: 30-Day Outcomes of the TRIOMPHE FDA Pivotal Study. The data demonstrate statistically significant improvement in clinical outcomes and device technical performance compared with the performance goals set forth in the FDA-approved investigational device exemption (IDE). *Major adverse events (MAEs) = mortality, disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, or development of new dissections in the thoracic aorta or brachiocephalic artery requiring intervention. Dr. Leshnower said, "The 30-day results from the TRIOMPHE study demonstrate that aneurysms due to chronic aortic arch dissection involving the aortic arch can be successfully treated with this novel off-the-shelf stent graft system. The NEXUS device provides an excellent, minimally invasive alternative to open aortic arch replacement in select patients at high risk for open surgery. This novel technology will extend treatment to patients who previously would not be offered therapy due to prohibitive risk" "We are pleased with the 30-day results and look forward to seeing the one-year outcomes," said Pat Mackin, Chairman, President and Chief Executive Officer of Artivion. "These results further validate this important therapeutic option for patients with aortic arch disease." About the NEXUS TRIOMPHE Clinical Trial The NEXUS TRIOMPHE trial is the US IDE study evaluating the NEXUS device in the endovascular treatment of chronic aortic dissection, either primary type B or residual dissection after prior type A repair, or aneurysm (not reported here). Inclusion criteria include the patient being high risk for open surgical repair. The clinical module of the PMA is anticipated to be filed after completion of one year of follow up with the 54 patients in the chronic aortic dissection statistical primary cohort. About Artivion, Inc. Headquartered in suburban Atlanta, Georgia, Artivion, Inc., is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, . References Leshnower B: Endovascular Aortic Arch Repair Using a Novel Single-Branch Arch Stent Graft for Chronic Dissection: 30-Day Outcomes of the TRIOMPHE FDA Pivotal Study. Presented May 3, 2025 at American Association of Thoracic Surgeons 105th annual meeting. Contacts: SOURCE Artivion, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

– Phase 2 TRANQUILITY trial in patients with elevated high-sensitivity C-reactive protein and chronic kidney disease remains on track for topline data readout in the second quarter 2025 – – Tourmaline expects to provide further details on the clinical development plan for pacibekitug within cardiovascular inflammation in conjunction with reporting TRANQUILITY topline data – – Cash, cash equivalents, and investments of $275.3 million as of March 31, 2025 provide expected cash runway into the second half of 2027 – NEW YORK, May 02, 2025 (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 first quarter of 2025 and outlined recent business highlights. “We continue to see growing evidence and enthusiasm for the potential of addressing IL-6-driven cardiovascular inflammation through our discussions with cardiovascular disease experts, attendance at major medical conferences, and review of constantly emerging scientific literature,” said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. “We look forward to the expected presentation of topline data from our Phase 2 TRANQUILITY trial of pacibekitug later in the second quarter. This readout has the potential to advance pacibekitug into the next stage of development within atherosclerotic cardiovascular disease, abdominal aortic aneurysm, and potentially other cardiovascular diseases.” Clinical Highlights and Upcoming Milestones: Cardiovascular Inflammation In December 2024, Tourmaline announced the over-enrollment of its Phase 2 TRANQUILITY trial, which evaluates quarterly and monthly subcutaneous dosing of pacibekitug in patients with elevated high-sensitivity C-reactive protein and chronic kidney disease. A total of 143 participants have been enrolled in the TRANQUILITY trial, as compared to 120 participants originally anticipated. Tourmaline remains on track to report topline data from the TRANQUILITY trial in the second quarter of 2025.The TRANQUILITY trial is the starting point of Tourmaline’s clinical development program for pacibekitug for the potential treatment of atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases. If successful, results from the TRANQUILITY trial are expected to position pacibekitug to be Phase 3-ready for ASCVD.At its Investor Day in December 2024, Tourmaline announced the nomination of abdominal aortic aneurysm (AAA) as an additional indication within its cardiovascular inflammation disease focus for pacibekitug. Tourmaline expects to provide additional details on a planned Phase 2 proof-of-concept trial in AAA in conjunction with the reporting of topline data from the TRANQUILITY trial. Thyroid Eye Disease (TED) The Phase 2b spiriTED trial remains ongoing, and Tourmaline expects to report topline data from this trial in the second half of 2025.Tourmaline expects to provide additional information on its future development plans in TED after review of data from the Phase 2b spiriTED trial. Publications and Presentations: Emil deGoma, MD, Tourmaline’s SVP of Medical Research was a contributing author and Dipender Gill, MD, PhD, a member of Tourmaline’s Cardiovascular Scientific Advisory Board, was the senior author on an original research manuscript entitled “Human Genetic Evidence to Inform Clinical Development of IL-6 Signaling Inhibition for Abdominal Aortic Aneurysm” that was published in the February 2025 issue of the American Heart Association’s Arteriosclerosis, Thrombosis, and Vascular Biology journal.In March 2025, representatives from Tourmaline presented a poster entitled “Real World Management Patterns and Outcomes in Thyroid Eye Disease: A Claims Analysis” at the North American Neuro-Ophthalmology Society 2025 Annual Meeting held in Tucson, Arizona.John Walsh, MD, Tourmaline’s Vice President, Head of Medical Affairs, Kristine Erickson, OD, PhD, Tourmaline’s Vice President and TA Head, Ophthalmology, Medical Research, and other representatives from Tourmaline were contributing authors to a publication entitled “The role of IL-6 in thyroid eye disease: An update on emerging treatments” that was published in the April 2025 issue of Frontiers in Ophthalmology. First Quarter 2025 Financial Results: Cash Position Cash, cash equivalents and investments were $275.3 million as of March 31, 2025, as compared to $294.9 million as of December 31, 2024. Tourmaline anticipates that its current cash, cash equivalents, and investments will provide cash runway into the second half of 2027, funding its operations through key pacibekitug data readouts in cardiovascular inflammation and TED as well as other pacibekitug development activities. Operating Expenses Research and development expenses were $20.3 million for the first quarter of 2025, as compared to $11.4 million for the first quarter of 2024. The increase in research and development expenses was primarily driven by increased clinical trial expenses directly related to the TRANQUILITY and spiriTED trials, increased employee compensation costs attributable to additional headcount, increased routine toxicology study expenses, and increased consulting expenses.General and administrative expenses were $6.0 million for the first quarter of 2025, as compared to $6.1 million for the first quarter of 2024. The decrease in general and administrative expenses was primarily driven by decreased consulting expenses. Net Loss Net loss was $23.0 million for the first quarter of 2025, resulting in a basic and diluted net loss per share of $0.89. Net loss was $13.3 million for the first quarter of 2024, resulting in basic and diluted net loss per share of $0.55.The increase in both net loss and net loss per share was attributable to increased operating expenses and Tourmaline’s overall growth from 2024 to 2025. 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 pacibekitug. For more information, please visit https://www.tourmalinebio.com or follow us on LinkedIn or X. About Pacibekitug: Pacibekitug 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. Pacibekitug has been previously studied in approximately 450 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is currently developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases in the future. 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 pacibekitug; the timing of initiation, progress and results of Tourmaline’s current and future clinical trials for pacibekitug, including reporting of data therefrom; the timing of Phase 3 clinical trial readiness; and the timing and potential to expand pacibekitug into additional indications. 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 genetic evidence or modeling data indicating the therapeutic potential of IL-6 inhibition, or clinical evidence from other drug candidates targeting IL-6, will not be replicated 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 profile that 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 on Tourmaline’s business, clinical trials and financial position; and other risks and uncertainties that are described in Tourmaline’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (“SEC”) on May 2, 2025 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.Condensed Consolidated Statements of Operations (unaudited)(amounts in thousands, except per share data) Three Months EndedMarch 31, 2025 2024 Operating expenses: Research and development$20,258 $11,376 General and administrative 5,973 6,141 Total operating expenses 26,231 17,517 Loss from operations (26,231) (17,517)Other income, net 3,261 4,206 Net loss$(22,970) $(13,311)Net loss per share, basic and diluted$(0.89) $(0.55)Weighted-average common shares outstanding, basic and diluted 25,692 24,082 Tourmaline Bio, Inc.Selected Condensed Consolidated Balance Sheet Data (unaudited)(amounts in thousands) March 31, December 31, 2025 2024Cash, cash equivalents and investments$275,306 $294,936Working capital$250,522 $259,933Total assets$287,498 $309,001Total stockholders’ equity$279,863 $300,052 Media Contact:Scient PR Sarah Mishek SMishek@ScientPR.com Investor Contact:Meru AdvisorsLee M. Sternlstern@meruadvisors.com