Microscopic Polyangiitis

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

HYDERABAD, India--( BUSINESS WIRE )--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI ® ) in European markets. Dr. Reddy’s had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad, India. As part of the established approval process, the CHMP positive opinion will now be reviewed by the European Commission (EC), following which a decision will be made on the grant of marketing authorisation in the European Union (EU) member countries, and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein. A Marketing Authorisation Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be made separately in keeping with the reliance route under the International Recognition Procedure (IRP). DRL_RI is being developed as a biosimilar of MabThera ® (Rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. ITUXREDI ® / DRL_RI (rituximab) is a proposed biosimilar to reference medicinal product MabThera ® and the intended indications are the same as those currently approved for MabThera®: Non–Hodgkin’s Lymphoma (NHL); Chronic Lymphocytic Leukaemia (CLL); Rheumatoid Arthritis (RA); Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA); Pemphigus Vulgaris (PV). EMA reference product, MabThera®, is a registered trademark of Roche. About Dr. Reddy’s biosimilars programme: Dr. Reddy’s biosimilars business is part of our key strategic initiatives expected to drive both near-term and long-term growth. Over the last 25 years, our Biologics team has developed into a fully integrated organisation with robust capabilities in the development, manufacture and commercialisation of a range of biosimilar products in oncology and immunology. We have a portfolio of commercial products in India, with some products marketed in more than 25 other countries. In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across regulated as well as emerging markets. We are also ramping up manufacturing capacity to support our global expansion plans. In July 2023, our proposed rituximab biosimilar application was accepted for review by the USFDA, EMA and MHRA. Earlier this year, we launched Versavo® (bevacizumab) in the UK, making it our first biosimilar product to be approved and launched in that country. About Dr. Reddy’s : Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com . Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2024. The company assumes no obligation to update any information contained herein.

After backing out from its public debut plans in 2022, Artiva Biotherapeutics is ready to make a second attempt at securing a NASDAQ listing. The cell therapy company aims to raise about $130 million in what could be the first IPO of the third quarter — hopefully signalling a turnaround from the previous period. IPO fundraising this year is on pace to surpass that of 2023 and 2022, but the fall-off of offerings from the first to second quarter — which saw just three public debuts — was striking, and is the largest ‘IPO cliff’ in recent memory. For further analysis, see Vital Signs: Bright spots in a sluggish IPO market.On a more positive note, the IPOs that have snuck out the door seem to be generally faring better than prior cohorts, with 40% trading above their debut price, in contrast to 22% from last year. Thanks to CG Oncology’s massive financing and positively trending share price, oncology is easily the best-performing disease area for IPOs this year, followed by neurology. While that may seem like a good sign for Artiva, whose most advanced programme is in a potentially registrational trial for Hodgkin lymphoma (HL), the biotech has recently been putting more of its cell therapy eggs into the autoimmune bucket — and inflammation has had the poorest IPO performance of any disease area. What’s more, the year’s loss leader, Kyverna Therapeutics is operating in a similar circle as Artiva: cell therapies for autoimmune diseases such as lupus.Autoimmune opportunityOn Monday, Artiva proposed to sell 8.7 million shares at a range of $14 and $16 each; at the midpoint, the biotech would raise $130.5 million and be valued at more than $260 million. The company’s lead candidate, AlloNK, is an allogeneic NK cell therapy intended to boost the antibody-dependent cellular cytotoxicity effect of B–cell-targeted antibodies. The experimental therapy is being tested in combination with an innate cell engager from Affimed, who is running the Phase II trial in patients with HL. Artiva launched its own study of AlloNK earlier this year in patients with lupus nephritis, for which it has FDA fast track designation. An investigator-initiated autoimmune disease basket trial, sponsored by a rheumatology clinic in Florida, is also underway and enrolling patients with rheumatoid arthritis, pemphigus vulgaris, and the anti-neutrophil cytoplasmic antibody associated vasculitis subtypes of granultomatosis with polyangiitis, and microscopic polyangiitis.Initial data from either the basket trial or Phase I lupus study are expected in the first half of next year. Artiva also has a pair of CAR-NK cell therapies in preclinical development for solid and liquid tumours, respectively, in partnership with GC Cell.