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Artiva Biotherapeutics, Inc.(ARTV) - 2025 Q4 - Annual Report
2026-03-10 20:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-42179 Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ☐ NO ☒ ...
Artiva Biotherapeutics, Inc.(ARTV) - 2025 Q4 - Annual Results
2026-03-10 20:07
Exhibit 99.1 Artiva Biotherapeutics Reports Full Year 2025 Financial Results and Recent Business Highlights Initial clinical response data for AlloNK® in refractory rheumatoid arthritis (RA) expected in first half of 2026 U.S. Food and Drug Administration (FDA) interaction to discuss potential pivotal trial design for AlloNK expected in first half of 2026 Strengthened board and executive leadership with deep immunology, commercial and financial expertise About Artiva Biotherapeutics Artiva is a clinical-sta ...
Artiva Biotherapeutics Reports Full Year 2025 Financial Results and Recent Business Highlights
Globenewswire· 2026-03-10 20:05
Core Insights - Artiva Biotherapeutics is advancing its AlloNK program for refractory rheumatoid arthritis (RA), with initial clinical response data expected in the first half of 2026 [1][10] - The company has received FDA Fast Track designation for AlloNK in refractory RA, highlighting the significant unmet need in this patient population [3] - Artiva's financial position remains robust, with cash, cash equivalents, and investments totaling $108.0 million as of December 31, 2025, expected to fund operations into Q2 2027 [1][10] Company Developments - Artiva has prioritized refractory RA as the lead indication for AlloNK, aiming to redefine treatment paradigms by combining deep B-cell depletion with an outpatient-ready profile [2][3] - The company has successfully enrolled patients across various autoimmune indications, with a focus on refractory RA, and plans to provide initial clinical response data from at least 15 patients [3][10] - Recent leadership appointments include Subhashis Banerjee, M.D. as chief medical officer and Thad Huston as chief financial officer, enhancing the company's expertise in rheumatology and financial strategy [4] Clinical and Financial Highlights - AlloNK plus rituximab has demonstrated deep and consistent B-cell depletion, achieving non-quantifiable peripheral CD19+ B-cell levels by Day 13 in treated patients [3] - The regimen has shown a favorable safety profile, with no reported cases of cytokine release syndrome or other severe adverse effects, facilitating strong patient enrollment [3] - For the year ended December 31, 2025, Artiva reported a net loss of $83.9 million, an increase from a net loss of $65.4 million in 2024, with research and development expenses rising to $69.5 million [10][15]
Artiva Biotherapeutics (NasdaqGM:ARTV) FY Conference Transcript
2026-03-04 19:12
Summary of Artiva Biotherapeutics FY Conference Call Company Overview - **Company**: Artiva Biotherapeutics (NasdaqGM:ARTV) - **Industry**: Biotechnology, specifically focusing on autoimmune diseases and cell therapy Core Points and Arguments Deep B-Cell Depletion Mechanism - Artiva emphasizes the potential of deep B-cell depletion as a transformative mechanism in treating autoimmune diseases, particularly in comparison to autologous CAR T therapies [2][24] - The company aims to differentiate itself by being the first to market with a deep B-cell depleting agent for rheumatoid arthritis (RA), targeting a significant unmet need in patients who have not responded to existing therapies [5][21] Lead Indication: Rheumatoid Arthritis - RA has been chosen as the lead indication due to its large population of refractory patients and the opportunity to be first in the market [5][6] - The company plans to initiate a registrational trial for RA in the first half of 2026, with an interaction with the FDA to discuss trial design [5][6][34] Efficacy and Safety Profile - Artiva has reported strong efficacy in treating aggressive non-Hodgkin's lymphoma, with complete response rates around 60% and durability of 19.4 months [10][11] - In a trial involving 32 patients with autoimmune conditions, no cases of cytokine release syndrome (CRS) were reported, indicating a favorable safety profile compared to existing therapies [4][14] Market Opportunity - The current market for RA treatments is approximately $20 billion, with $5 billion attributed to patients on third-line therapies, which have a low response rate of 10%-20% [9][21] - Artiva aims to capture this market by providing a therapy that could achieve ACR50 responses of 50% or greater in patients who have failed multiple therapies [8][9][34] Scalability and Cost of Goods Sold (COGS) - The company utilizes umbilical cord-derived NK cells, which allows for scalable production, with a COGS estimated at $1,000 or less per vial containing 1 billion cells [12][13] - The treatment is designed to be administered in a community setting, enhancing accessibility and ease of use [18][27] Future Indications - Beyond RA, Artiva is also exploring indications for Sjögren's disease, scleroderma, and myositis, with a focus on community access and scalability [6][42][43] - The company plans to take a data-driven approach, prioritizing one indication at a time for further development [44] Additional Important Insights - Artiva's approach to community administration of Cyclophosphamide and Fludarabine has shown feasibility, with positive outcomes in patient management and tolerability [27][29] - The company has a cash balance of $123 million as of Q3 2025, providing a runway into Q2 2027 for ongoing development [22] - Artiva's strategy involves understanding the competitive landscape and focusing on indications where they can lead, rather than competing in crowded spaces [25][26] Conclusion - Artiva Biotherapeutics is positioned to potentially revolutionize the treatment of autoimmune diseases through its innovative deep B-cell depletion therapy, with a strong focus on RA as its lead indication and a commitment to safety, efficacy, and scalability in treatment delivery [21][45]
Artiva Biotherapeutics to Participate in the TD Cowen 46th Annual Health Care Conference
Globenewswire· 2026-02-25 13:00
SAN DIEGO, Feb. 25, 2026 (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 that Artiva management will participate in a fireside chat at the TD Cowen 46th Annual Health Care Conference on Wednesday, March 4, 2026, at 1:10 p.m. EST, in Boston, MA. Members of the Artiva management team will also be availab ...
Artiva Biotherapeutics Announces Appointment of Thad Huston as Chief Financial Officer and Award of Inducement Grant
Globenewswire· 2026-02-24 13:00
Core Insights - Artiva Biotherapeutics has appointed Thad Huston as Chief Financial Officer, bringing extensive experience in capital allocation and operational execution to support the company's growth in cell therapies for autoimmune diseases and cancers [1][2]. Company Overview - Artiva Biotherapeutics is a clinical-stage biotechnology company focused on developing safe and effective cell therapies for patients with autoimmune diseases and cancers [1][6]. - The company's lead program, AlloNK, is an allogeneic NK cell therapy designed to enhance the efficacy of monoclonal antibodies for B-cell depletion [6]. Leadership Appointment - Thad Huston has over 30 years of global leadership experience in finance, commercial strategy, and operations within the pharmaceuticals and biotechnology sectors [2]. - Huston previously served as CFO and COO at Galapagos, leading the company's transition to an oncology-focused cell therapy organization [2]. Inducement Grant - Artiva's Board of Directors approved an employment inducement grant of 220,000 restricted stock units to Mr. Huston, which will vest over four years [3][4]. - The grant is contingent upon the filing of a registration statement to register the shares under Artiva's 2025 Inducement Plan [4][5]. Clinical Development - AlloNK is currently being evaluated in three clinical trials targeting B-cell driven autoimmune diseases, including rheumatoid arthritis and Sjögren's disease [6]. - The company is preparing to receive feedback from the FDA regarding a potential pivotal trial and plans to share clinical efficacy data in rheumatoid arthritis in the first half of the year [2]. Strategic Positioning - Artiva aims to position itself for sustained growth by leveraging Huston's financial discipline and operational rigor as it approaches key clinical and regulatory milestones [2].
Artiva Biotherapeutics Announces Appointment of Elaine Sorg to Board of Directors
Globenewswire· 2026-02-19 13:00
Core Insights - Artiva Biotherapeutics, Inc. has appointed Elaine Sorg to its Board of Directors, bringing over 35 years of experience in the biopharmaceutical industry, particularly in immunology therapies [1][2] - The company is preparing to share clinical activity data from its AlloNK regimen for rheumatoid arthritis and engage with the FDA for a registrational trial, indicating a significant phase in its development [2] - AlloNK is positioned as a potentially transformative treatment for autoimmune diseases, with a focus on B-cell depletion and improved efficacy compared to existing therapies [2][4] Company Overview - Artiva Biotherapeutics is a clinical-stage biotechnology company focused on developing cell therapies for autoimmune diseases and cancers, with its lead program being AlloNK, a non-genetically modified NK cell therapy [4][5] - The company was founded in 2019 as a spin-out from GC Cell, acquiring exclusive worldwide rights to NK cell manufacturing technology [4] Leadership Experience - Elaine Sorg has held senior executive roles at major pharmaceutical companies, including AbbVie and Eli Lilly, where she was instrumental in the commercialization of key immunology products [2][3] - Her experience includes leading U.S. commercialization efforts for a broad portfolio of medicines and overseeing major autoimmune disease brands [2][3]
Artiva Biotherapeutics: Upcoming Data Presentations May Bring Them Out Of Being Ignored
Seeking Alpha· 2026-01-16 01:02
Core Insights - Artiva Biotherapeutics (ARTV) is focused on developing cell therapies aimed at treating autoimmune diseases, positioning itself in a niche market within the biotechnology sector [1] Company Overview - Artiva Biotherapeutics is one of the few companies dedicated to cell therapies for autoimmune diseases, indicating a specialized focus in a competitive industry [1] Industry Context - The biotechnology industry is currently experiencing a trend towards engineered cell therapies, particularly those designed to downregulate immune responses, highlighting the innovative direction of the sector [1]
Crude Oil Falls Over 1%; US Homebuilder Sentiment Edges Higher In December - Argo Blockchain (NASDAQ:ARBK), Artiva Biotherapeutics (NASDAQ:ARTV)
Benzinga· 2025-12-15 17:30
Market Overview - U.S. stocks experienced a decline, with the Nasdaq Composite falling approximately 0.4% on Monday. The Dow decreased by 0.27% to 48,328.47, while the S&P 500 dropped 0.11% to 6,819.62 [1] - In the commodities market, oil prices fell by 1.5% to $56.58, while gold decreased by 0.1% to $4,366.60. Conversely, silver rose by 2.2% to $63.395, and copper increased by 1.1% to $5.4175 [5] Sector Performance - Health care shares saw an increase of 0.9% on Monday, indicating a positive trend in that sector [1] - Energy stocks, however, experienced a decline of 1.5% [1] International Markets - European shares showed positive performance, with the eurozone's STOXX 600 gaining 0.74%. Spain's IBEX 35 Index rose by 1.11%, and London's FTSE 100 jumped by 1.06% [6] - In contrast, Asian markets closed lower, with Japan's Nikkei falling by 1.31% and Hong Kong's Hang Seng dipping by 1.34% [7] Economic Indicators - The NAHB/Wells Fargo Housing Market Index increased to 39 in December, marking the highest reading in eight months, up from 38 in November and exceeding market estimates of 38 [2][10] - The NY Empire State Manufacturing Index fell to -3.9 in December, a significant drop from the previous month's one-year high of 18.7, and below market expectations of 10 [8] Company News - 3 E Network Technology Group Ltd (NASDAQ:MASK) shares surged by 47% to $0.44 following a master services agreement for an AI data center in Finland [9] - Kyverna Therapeutics Inc (NASDAQ:KYTX) shares rose by 28% to $11.22 after announcing topline data from KYSA-8 [9] - Artiva Biotherapeutics Inc (NASDAQ:ARTV) shares increased by 50% to $4.94 after reporting positive initial safety data [9] - iRobot Corp (NASDAQ:IRBT) shares plummeted by 72% to $1.20 after filing for Chapter 11 bankruptcy [9] - Argo Blockchain PLC – ADR (NASDAQ:ARBK) shares fell by 22% to $5.35 amid volatility in the cryptocurrency market [9] - Momentus Inc (NASDAQ:MNTS) shares dropped by 43% to $0.48 following a 1-for-17.85 reverse split announcement [9]
Wedbush Predicts Up to ~600% Jump for These 2 ‘Strong Buy’ Stocks
Yahoo Finance· 2025-12-14 11:05
Group 1: Artiva Biotherapeutics - Artiva is developing AlloNK, a natural killer (NK) cell-based therapy for autoimmune diseases and cancers, with ongoing clinical trials for conditions like refractory rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) [2][6] - The FDA granted Fast Track designation to AlloNK for refractory RA, highlighting its potential to meet the needs of over 150,000 U.S. patients who have not responded to existing treatments [6] - Recent data from 32 patients treated with AlloNK showed no cases of cytokine release syndrome or neurotoxicity, with all patients achieving complete B-cell depletion by Day 13 [7] Group 2: Market Potential and Analyst Ratings - Wedbush analyst Martin Fan projects a price target of $23 for Artiva, indicating a potential upside of approximately 600% over the next 12 months, supported by a Strong Buy consensus from analysts [10] - The SPDR S&P Biotech ETF (XBI) has increased by about 37% year-to-date, suggesting a growing interest in the biotech sector amid a pause in AI market leadership [4] - Artiva's shares are currently trading at $3.30, which is below its cash value of $5 per share, indicating potential for substantial appreciation as clinical data emerges [10] Group 3: BioCryst Pharmaceuticals - BioCryst has transitioned into a profitable biotech company, driven by its focus on rare diseases and the success of its drug Orladeyo, which generated $159.1 million in net revenue for Q3 2025, a 37% year-over-year increase [14][15] - The FDA recently approved an oral pellet formulation of Orladeyo for pediatric patients, expanding its market reach and potential revenue, with estimates suggesting it could generate $1 billion in peak annual revenue by 2029 [15] - BioCryst's stock is trading at $7.57, with an average price target of $19.27, implying a potential gain of 154% over the next 12 months, supported by a Strong Buy consensus from analysts [19]