Granulomatosis With Polyangiitis

WASHINGTON, Nov. 18, 2024 /PRNewswire/ -- New research to be presented by an investigator from Hospital for Special Surgery (HSS) shows avacopan is effective in achieving disease control with less steroid exposure in patients with ear, nose and throat (ENT) manifestations of ANCA associated vasculitis - Robert F. Spiera, MD, Director of the Scleroderma, Vasculitis, and Myositis Center at Hospital for Special Surgery (HSS), helped lead this latest analysis which was presented at the ACR Convergence 2024, the annual meeting of the American College of Rheumatology. The study built on the pivotal ADVOCATE trial, focusing on patients with the most severe manifestations of vasculitis in the ENT region, which has historically been harder to treat. Avacopan (Tavneos, Amgen) was approved by the US Food and Drug Administration in 2021 for the treatment of severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, a rare autoimmune disorder that can cause potentially life-threatening inflammation by restricting blood flow to vital organs. Once considered a fatal condition, ANCA associated vasculitis is now treatable, especially if identified early and treated with appropriate immunsosuppressive medications. Avacopan is a targeted therapy that offers a safer and more effective alternative to prednisone which had traditionally been a mainstay of remission induction therapy in these disorders but carries with it high risks such as infections, weight gain, diabetes, and bone thinning. While the original ADVOCATE trial established the avacopan as an improved treatment option, the new analysis zeroes in on a group of patients whose disease has historically been more difficult to treat – those with ENT involvement. These patients often experience debilitating symptoms such as pain, hearing loss, and chronic inflammation, which severely impact quality of life. "We know patients with this disease often achieve remission in their kidneys and lungs, but ENT disease frequently becomes a significant factor impacting their quality of life," Dr. Spiera said. "This analysis provides crucial insights, showing that avacopan not only brings faster relief but sustains improvement over time in patients with those manifestations." The new analysis focused on a subgroup of 144 patients from the ADVOCATE trial, all of whom had severe ENT symptoms. Findings revealed that patients treated with avacopan showed significant improvements as early as week 4, with results continuing to favor avacopan over prednisone at week 52. Remarkably, 71% of these patients reached remission at 26 weeks, closely mirroring the remission rates in the broader trial. Beyond clinical improvement, patients taking avacopan reported higher quality of life scores compared to the group taking prednisone. "Avacopan offers these patients a real opportunity to live with fewer limitations," noted Dr. Spiera. Equally important, the study showed that avacopan's safety profile was comparable to that of prednisone, with similar rates of adverse events such as infections. "These encouraging results underscore the importance of considering avacopan, for patients with microscopic polyangiitis and granulomatosis with polyangiitis with active ENT symptoms," Dr. Spiera said. About HSS HSS is the world's leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 15th consecutive year), No. 3 in rheumatology by U.S. News & World Report (2024-2025), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report "Best Children's Hospitals" list (2024-2025). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked world #1 in orthopedics for a fifth consecutive year (2025). Founded in 1863, the Hospital has the lowest readmission rates in the nation for orthopedics, and among the lowest infection and complication rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. In addition, more than 200 HSS clinical investigators are working to improve patient outcomes through better ways to prevent, diagnose, and treat orthopedic, rheumatic and musculoskeletal diseases. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 165 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. . SOURCE Hospital for Special Surgery WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Expanded Board of Directors with appointment of Dr. Alison Moore bringing cell therapy and manufacturing expertise to advance AlloNK® in autoimmune diseases Initial data for AlloNK® in autoimmune indications expected H1 2025 Robust balance sheet with cash, cash equivalents and investments of $199.6 million as of September 30, 2024, is expected to fund operations at least through end of 2026 SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced financial results for the third quarter ended September 30, 2024, and highlighted recent progress. “As AlloNK® advances in the clinic, we were pleased to expand our Board of Directors with the appointment of Dr. Alison Moore, an experienced executive in manufacturing and technical operations in allogenic cell therapies,” said Fred Aslan, M.D., CEO of Artiva. “We remain focused on generating clinical data and strengthening Artiva’s talent in autoimmune disease and cell therapy across the organization as we prepare for this next stage of growth.” Recent Business Highlights Corporate and Financial Updates Expanded Board of Directors: In October 2024, Artiva appointed Alison Moore, Ph.D., as an independent member of its Board of Directors. Dr. Moore brings over 25 years of executive experience in the biotechnology and pharmaceutical industry, including an extensive background in cell therapy manufacturing. She currently serves as Chief Technical Officer (CTO) of Codexis Inc., a leading enzyme engineering company, and was the former CTO of Allogene Therapeutics, a pioneering clinical-stage company advancing CAR T-cell therapies.Completed upsized $179.0 Million initial public offering: In July 2024, Artiva sold 14,920,000 shares of its common stock, including partial exercise of the overallotment option, at a public offering price of $12.00 per share, for gross proceeds of $179.0 million. AlloNK® Clinical Updates In August 2024, Artiva announced the treatment of its first patient was initiated in an investigator-initiated basket trial (IIT) assessing the safety, tolerability, and clinical activity of AlloNK® (AB-101) in combination with rituximab in patients with rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis/microscopic polyangiitis, and systemic lupus erythematosus (SLE). The trial is being conducted by Integral Rheumatology & Immunology Specialists, a community rheumatology clinic, demonstrating the potential to bring AlloNK® to patients in a community setting in addition to academic and transplant centers. AlloNK® is also in clinical evaluation in combination with rituximab or obinutuzumab in an Artiva sponsored Phase 1/1b trial for treatment of SLE, for patients with or without lupus nephritis. Initial data for AlloNK® in autoimmune indications from the Phase 1/1b trial or the basket IIT expected in the first half of 2025. Third Quarter 2024 Financial Results Cash, Cash Equivalents and Investments. As of September 30, 2024, Artiva had cash, cash equivalents, and investments of $199.6 million. This includes $179.0 million in gross proceeds from Artiva’s completed initial public offering in July 2024 in which it sold 14,920,000 shares of its common stock, including partial exercise of the overallotment option. Existing cash, cash equivalents, and investments as of September 30, 2024, are expected to fund operations at least through the end of 2026 and through key clinical data milestones.Collaboration Revenue. Collaboration revenue was $0 for the three months ended September 30, 2024, compared to $26.7 million for the three months ended September 30, 2023. Revenues in 2023 were related to the Merck Sharpe & Dohme Corp. collaboration which was terminated in October 2023.Research and Development Expenses. Research and development expenses were $13.5 million for the three months ended September 30, 2024, compared to $13.1 million for the three months ended September 30, 2023.General and Administrative Expenses. General and administrative expenses were $4.8 million for the three months ended September 30, 2024, compared to $2.8 million for the three months ended September 30, 2023.Other Income (Expense), net. Other income (expense), net, was $0.9 million for the three months ended September 30, 2024, compared to other income (expense), net, of $0.5 million for the three months ended September 30, 2023. Net Income (Loss). Net loss totaled $17.5 million for the three months ending September 30, 2024, as compared to net income of $11.3 million for the three months ending September 30, 2023, with non-cash stock-based compensation expense of $1.9 million and $1.4 million for the three months ended September 30, 2024 and 2023, respectively. About Artiva Biotherapeutics Artiva is a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK® is currently in clinical trials for treatment of systemic lupus erythematosus, for patients with or without lupus nephritis, and in an investigator-initiated basket trial in multiple autoimmune indications. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, please visit www.artivabio.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Artiva Biotherapeutics, Inc. (the “Company”) regarding the potential benefits, accessibility, effectiveness and safety of AlloNK®; the Company’s ability to advance AlloNK® in autoimmune disease; the Company’s expectations regarding timing and availability of data from the Phase 1/1b trial or the IIT; and the Company’s future results of operations and financial position, including cash runway. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Artiva Biotherapeutics, Inc.Condensed Balance Sheets(unaudited)(in thousands) September 30, 2024 December 31, 2023Assets Cash, cash equivalents and investments$199,597 $76,971 Property and equipment, net 6,857 8,096 Operating and financing lease right-of-use assets 14,652 16,547 Other assets 4,490 3,500 Total assets$225,596 $105,114 Liabilities, convertible preferred stock, and stockholders' equity (deficit) Accounts payable and accrued expenses$9,559 $8,631 Operating and financing lease liabilities 14,968 16,912 Simple agreements for future equity (SAFEs) — 25,100 Other liabilities 73 73 Total liabilities 24,600 50,716 Convertible preferred stock — 216,413 Stockholders' equity (deficit) 200,996 (162,015)Total liabilities, convertible preferred stock, and stockholders' equity (deficit)$225,596 $105,114 Artiva Biotherapeutics, Inc. Condensed Statements of Operation and Comprehensive Income (Loss) (unaudited) (in thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenue Collaboration revenue$— $26,656 $— $31,142 License and development support revenue — — 251 — Total revenue — 26,656 251 31,142 Operating expenses: Research and development 13,524 13,065 37,011 39,098 General and administrative 4,811 2,780 12,255 10,745 Total operating expenses 18,335 15,845 49,266 49,843 Income (loss) from operations (18,335) 10,811 (49,015) (18,701)Other income (expense) Interest income 1,846 418 3,172 1,952 Change in fair value of SAFEs (977) — (3,597) — Other income (expense), net (6) 50 162 27 Total other income (expense) 863 468 (263) 1,979 Net income (loss)$(17,472) $11,279 $(49,278) $(16,722)Net income (loss) per share, basic$(0.92) $13.98 $(7.16) $(20.89)Net income (loss) per share, diluted$(0.92) $1.62 $(7.16) $(20.89)Weighted-average common shares outstanding, basic 18,896,829 806,714 6,883,271 800,541 Weighted-average common shares outstanding, diluted 18,896,829 6,967,099 6,883,271 800,541 Comprehensive income (loss): Net income (loss)$(17,472) $11,279 $(49,278) $(16,722)Other comprehensive income 217 144 30 271 Comprehensive income (loss)$(17,255) $11,423 $(49,248) $(16,451) ContactsInvestors: Neha Krishnamohan, Artiva Biotherapeutics, ir@artivabio.comMedia: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com, +1.858.344.8091 Source: Artiva Biotherapeutics, Inc.

Strong balance sheet with successful completion of upsized $179.0 million initial public offering Treatment initiated in the first patient in an investigator-initiated basket trial of AlloNK® exploring multiple autoimmune indicationsTreated first patient in Artiva sponsored Phase 1/1b trial in patients with class III or IV lupus nephritis (LN) and expanded trial to include patients with systemic lupus erythematosus (SLE) without kidney involvement SAN DIEGO, Aug. 29, 2024 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced financial results for the second quarter ended June 30, 2024, and highlighted recent progress. “Artiva is at an inflection point as we advance AlloNK® in clinical development across multiple autoimmune indications and transition to a publicly traded company,” said Fred Aslan, M.D., Artiva’s Chief Executive Officer. “With two trials in autoimmunity underway, we are focused on the potential of AlloNK® in delivering effective, safe, and accessible cell therapies for patients with devastating autoimmune disease.” Recent Business Highlights AlloNK® Treatment initiated in the first patient in an investigator-initiated basket trial (IIT) exploring AlloNK® in combination with rituximab in patients with rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis/microscopic polyangiitis, and SLE. The trial is being conducted by Integral Rheumatology & Immunology Specialists (IRIS), a community rheumatology clinic, demonstrating the potential to bring AlloNK® to patients in a community setting in addition to academic and transplant centers. The study is assessing the safety, tolerability, and clinical activity of AlloNK® (also known as AB-101). Announced treatment of the first LN patient in Artiva sponsored Phase 1/1b trial in April 2024. To Artiva's knowledge, this marks the first patient to receive an allogeneic, off-the-shelf NK cell therapy in a U.S. clinical trial for treatment of an autoimmune disease. In the Phase 1/1b trial, AlloNK® will be administered in combination with rituximab or obinutuzumab. The trial was expanded to include patients with SLE without kidney involvement.Expect to report initial data on autoimmune indications from at least one of the Phase 1/1b trial or the basket IIT in the first half of 2025. Corporate and Financial Updates Significantly extended cash runway through the completion of Artiva’s initial public offering (IPO). Strengthened balance sheet with approximately $179.0 million in gross proceeds from the IPO in July 2024, which extends cash runway at least through the end of 2026 and through key clinical data milestones. Second Quarter 2024 Financial Results Cash, Cash Equivalents and Short-Term Investments. As of June 30, 2024, Artiva had cash, cash equivalents, and short-term investments of $46.6 million. In addition, Artiva completed its IPO in July 2024 in which it sold 14,920,000 shares of its common stock, including partial exercise of the overallotment option, for gross proceeds of $179.0 million. Collaboration Revenue. Collaboration revenue was $0 for the three months ended June 30, 2024, compared to $3.5 million for the three months ended June 30, 2023. Revenues in 2023 were related to the Merck Sharpe & Dohme Corp. collaboration which was terminated in October 2023. Research and Development Expenses. Research and development expenses were $12.3 million for the three months ended June 30, 2024, compared to $11.3 million for the three months ended June 30, 2023. General and Administrative Expenses. General and administrative expenses were $3.9 million for the three months ended June 30, 2024, compared to $4.1 million for the three months ended June 30, 2023.Other Income (Expense), net. Other expense, net, was $1.7 million for the three months ended June 30, 2024, compared to other income, net, of $0.5 million for the three months ended June 30, 2023. Other expense, net, for the three months ended June 30, 2024, includes a loss on change in fair value of simple agreements for future equity (SAFEs) of $2.4 million. Net Loss. Net loss totaled $17.8 million for the three months ending June 30, 2024, as compared to $11.3 million for the three months ending June 30, 2023, with non-cash stock-based compensation expense of $1.5 million and $2.5 million for the three months ended June 30, 2024 and 2023, respectively. About Artiva Biotherapeutics Artiva is a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK® is currently in clinical trials for treatment of systemic lupus erythematosus, for patients with or without lupus nephritis, and in an investigator-initiated basket trial in multiple autoimmune indications. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, please visit https://www.artivabio.com/. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Artiva Biotherapeutics, Inc. (the “Company”) regarding the potential benefits, accessibility, effectiveness and safety of AlloNK®; the Company’s expectations regarding timing and availability of data from the Phase 1/1b trial or the IIT; and the Company’s future results of operations and financial position, including cash runway. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties, including business, regulatory, economic and competitive risks and uncertainties about the Company, including, without limitation, risks inherent in developing product candidates, future results from the Company’s ongoing and planned clinical trials, risks related to conducting clinical trials, including delays in activation of clinical trial sites or in subject enrollment, the Company’s ability to obtain adequate financing to fund its planned clinical trials and other expenses, risks that future clinical trial results may not be consistent with interim, initial or preliminary results or results from prior preclinical studies or clinical trials, trends in the industry, the Company’s relationships with its existing and future collaboration partners, the legal and regulatory framework for the industry and future expenditures. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material. Other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Artiva Biotherapeutics, Inc.Condensed Balance Sheets(unaudited)(in thousands) June 30, 2024 December 31,2023Assets Cash, cash equivalents and short-term investments$46,556 $76,971 Property and equipment, net 7,315 8,096 Operating and financing lease right-of-use assets 15,420 16,547 Other assets 6,621 3,500 Total assets$75,912 $105,114 Liabilities, convertible preferred stock, and stockholders' deficit Accounts payable and accrued expenses$7,037 $8,631 Operating and financing lease liabilities 15,765 16,912 Simple agreements for future equity (SAFEs) 27,720 25,100 Other liabilities 74 73 Total liabilities 50,596 50,716 Convertible preferred stock 216,413 216,413 Stockholders' deficit (191,097) (162,015)Total liabilities, convertible preferred stock, and stockholders' deficit$75,912 $105,114 Artiva Biotherapeutics, Inc.Condensed Statements of Operation and Comprehensive Loss(unaudited)(in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Revenue Collaboration revenue$— $3,497 $— $4,487 License and development support revenue — — 251 — Total revenue — 3,497 251 4,487 Operating expenses: Research and development 12,333 11,262 23,488 26,033 General and administrative 3,857 4,059 7,444 7,965 Total operating expenses 16,190 15,321 30,932 33,998 Loss from operations (16,190) (11,824) (30,681) (29,511)Other income (expense) Interest income 676 509 1,326 1,533 Change in fair value of SAFEs (2,352) — (2,620) — Other income (expense), net 23 31 169 (23)Total other income (expense) (1,653) 540 (1,125) 1,510 Net loss$(17,843) $(11,284) $(31,806) $(28,001)Net loss per share, basic and diluted$(22.00) $(14.09) $(39.24) $(35.12)Weighted-average common shares outstanding, basic and diluted 811,210 800,889 810,484 797,403 Comprehensive loss: Net Loss$(17,843) $(11,284) $(31,806) $(28,001)Other comprehensive income (loss) (86) 127 (187) 127 Comprehensive loss$(17,929) $(11,157) $(31,993) $(27,874) ContactsInvestors: Neha Krishnamohan, Artiva Biotherapeutics, ir@artivabio.comMedia: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com, +1.858.344.8091