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AnaptysBio, Inc. (Nasdaq: ANAB) is a clinical-stage biotechnology company dedicated to developing innovative immunology therapeutics to address unmet medical needs. Founded in 2005, AnaptysBio leverages its proprietary SHM-XEL platform to generate high-affinity therapeutic antibodies by harnessing the natural process of somatic hypermutation (SHM) under controlled conditions. The SHM-XEL platform mimics key features of the human immune system and overcomes the limitations of prior antibody technologies.
Headquartered in San Diego, AnaptysBio is focused on creating a robust pipeline of novel therapeutic antibody candidates targeting autoimmune, inflammatory, and oncology indications. The company boasts a portfolio that includes clinical-stage immune cell modulators such as rosnilimab (PD-1 agonist) and ANB032 (BTLA agonist), both in Phase 2 trials for rheumatoid arthritis (RA), ulcerative colitis (UC), and atopic dermatitis (AD).
AnaptysBio has shown significant progress in its clinical programs. Notably, the company reported positive top-line results from its global Phase 3 GEMINI-1 and GEMINI-2 trials evaluating imsidolimab (IL-36R mAb) for generalized pustular psoriasis (GPP). The results demonstrated rapid clearance of GPP symptoms with a single intravenous dose followed by effective maintenance with monthly subcutaneous doses.
Financially, AnaptysBio is on solid ground, reiterating a cash runway through year-end 2026 with expected year-end 2023 cash and investments of $400 to $410 million. The company's strategic collaborations, including its partnership with GSK for Jemperli (dostarlimab-gxly), provide additional financial support and validation of their therapeutic candidates' commercial potential.
Recently, AnaptysBio announced an exclusive license agreement with Centessa Pharmaceuticals for a BDCA2 modulator portfolio, including ANB101, further expanding its pipeline. The company plans to submit investigational new drug (IND) applications for ANB033 (anti-CD122 antagonist) and ANB101 in 2024.
With a commitment to patient-centric innovation and a strategic approach to partnerships and financial management, AnaptysBio continues to advance its mission of delivering transformative therapies to improve patients' lives globally.
AnaptysBio, a clinical-stage biotechnology company focused on innovative immunology therapeutics, announced that interim president and CEO Dan Faga will present at the Cowen and Company 43rd Annual Health Care Conference on March 6, 2023, at 2:50 p.m. ET. The presentation will be accessible via a live audio webcast on the company’s investor website, with a replay available for 30 days post-event.
The company is working on immune cell modulators for autoimmune and inflammatory diseases, including a planned Phase 2b trial for its PD-1 agonist, rosnilimab, and BTLA agonist, ANB032. AnaptysBio’s portfolio also includes several therapeutic antibodies developed in collaboration with GSK.
AnaptysBio, a clinical-stage biotechnology firm, announced a $50 million Stock Repurchase Plan, authorized by its Board of Directors. This initiative comes as the company reports having over $575 million in cash as of December 31, 2022, allowing it to maintain approximately four years of capital for its research and development projects. The buyback, which can occur through open market transactions, aims to enhance shareholder value. While the plan may be executed before its expiration on December 31, 2023, it does not obligate AnaptysBio to repurchase a specific number of shares.
AnaptysBio announced the advancement of its product candidates with two global Phase 2b trials: rosnilimab, a PD-1 agonist for rheumatoid arthritis, starting in Q3 2023, and ANB032, a BTLA agonist for atopic dermatitis, in Q2 2023. Despite promising interim data showing safety for rosnilimab in alopecia areata, the SALT scores did not meet target efficacy, halting further development in this area. The company ended 2022 with over $575 million in capital, providing approximately four years of runway for research and development initiatives.
AnaptysBio announced that the Phase 3 RUBY trial of JEMPERLI plus chemotherapy met its primary endpoint, significantly improving progression-free survival (PFS) in patients with advanced or recurrent endometrial cancer. The trial's favorable results for the dMMR/MSI-H subgroup could drive substantial royalties for AnaptysBio. Regulatory submissions are expected in early 2023, with GSK planning to publish full results soon. JEMPERLI, developed by AnaptysBio, is a PD-1-blocking antibody indicated for specific endometrial cancer cases.
AnaptysBio, a clinical-stage biotechnology firm, announced that CEO Dan Faga will participate in a fireside chat at the Guggenheim 4th Annual Immunology and Neurology Conference on November 14, 2022. The session is scheduled for 1:00 p.m. ET. Additionally, the senior management team will conduct investor meetings at the Jefferies London Healthcare Conference on November 16, 2022. An audio webcast of the event will be available on AnaptysBio's investor website and can be replayed for 30 days post-event.
AnaptysBio reported its Q3 2022 operating results, highlighting key developments in its immune cell modulator pipeline. The company anticipates top-line data for its anti-PD-1 agonist, Rosnilimab, in Q1 2023, and has progressed its anti-BTLA agonist, ANB032, towards a Phase 2 trial with IND submission expected in Q4 2022. The company sold its Zejula royalty interest for up to $45 million. Despite having $590 million in cash, AnaptysBio faced a net loss of $33.5 million, a significant increase from last year, attributed to rising general and administrative expenses.
AnaptysBio announced positive results from the PERLA Phase 2 trial, comparing JEMPERLI against Keytruda in metastatic non-squamous lung cancer, achieving its primary endpoint of objective response rate (ORR). Additionally, the COSTAR trial, evaluating JEMPERLI in combination with cobolimab, met its pre-specified efficacy and safety criteria, allowing progression to Phase 3. AnaptysBio expects to receive a $5 million milestone payment from GSK upon dosing the first patient in the Phase 3 COSTAR trial. JEMPERLI is being developed for various advanced cancers, while cobolimab is an investigational TIM-3 antagonist.
AnaptysBio, a clinical-stage biotechnology company, announced the sale of its royalty interest in Zejula to DRI Healthcare Trust for up to $45 million. The company received an upfront payment of $35 million for a 1% royalty on global net sales, which is effectively 0.5% due to third-party royalties. AnaptysBio stands to gain an additional $10 million contingent upon FDA approval of Zejula for endometrial cancer, expected by December 31, 2025. This sale supports their focus on innovative immunology therapeutics.
AnaptysBio announced disappointing results from its HARP Phase 2 trial of imsidolimab, an anti-IL-36 receptor antagonist for hidradenitis suppurativa, which showed no significant efficacy over placebo in primary and key secondary endpoints. The company will discontinue this clinical development but continues to enroll patients in the GEMINI-1 Phase 3 trial for generalized pustular psoriasis (GPP), with top-line data expected in Q4 2023. AnaptysBio plans to outlicense imsidolimab prior to FDA approval and shift focus to its immune cell modulator pipeline, including two checkpoint agonists, rosnilimab and ANB032.
AnaptysBio (ANAB) reported Q2 2022 results, highlighting an operating cash position of $572.1 million, with anticipated net cash burn estimated at $90-$100 million for 2022.
Collaboration revenue fell significantly to $1.2 million compared to $30 million a year prior. Research and development expenses decreased to $20.8 million, while general and administrative costs increased to $8.2 million due to personnel changes. The company posted a net loss of $32.6 million for Q2, with a net loss per share of $1.15, up from a $0.4 million loss in Q2 2021.
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