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Anaptys Announces Participation in March Investor Conferences
Globenewswire· 2025-02-27 21:15
Company Overview - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [2] - The lead program, rosnilimab, targets PD-1+ T cells and is currently in Phase 2b trials for rheumatoid arthritis and Phase 2 trials for ulcerative colitis [2] - Other antibodies in the portfolio include ANB033, a CD122 antagonist in Phase 1 trials, and ANB101, a BDCA2 modulator entering Phase 1 trials [2] - Anaptys has licensed multiple therapeutic antibodies to GSK for immuno-oncology, including a PD-1 antagonist (Jemperli) and a TIM-3 antagonist (cobolimab) [2] Upcoming Events - Daniel Faga, CEO of Anaptys, and other executive team members will participate in several investor conferences [1] - Conferences include TD Cowen 45th Annual Healthcare Conference in Boston, Leerink Partners 2025 Global Healthcare Conference in Miami, and Barclays 27th Annual Global Healthcare Conference in Miami [1] - Live webcasts of the events will be available on the Anaptys investor website, with replays accessible for at least 30 days [1] Event Schedule - Fireside chat and one-on-one investor meetings on March 4, 2025, at 1:10 PM ET / 10:10 AM PT [3] - Fireside chat and one-on-one investor meetings on March 11, 2025, at 10:40 AM ET / 7:40 AM PT [3] - Presentation and one-on-one investor meetings on March 12, 2025, at 8:30 AM ET / 5:30 AM PT [3]
Anaptys Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Globenewswire· 2025-02-27 21:15
Core Insights - AnaptysBio reported positive Phase 2b data for rosnilimab in rheumatoid arthritis, demonstrating impressive safety, tolerability, and sustained efficacy [2][4] - The company has a strong cash position of approximately $420 million, ensuring funding through the end of 2027 [2][8] - Upcoming data releases include full clinical results for rosnilimab in rheumatoid arthritis in Q2 2025 and top-line Phase 2 data for ulcerative colitis in Q4 2025 [2][4] Financial Performance - For Q4 2024, collaboration revenue was $43.1 million, a significant increase from $9.0 million in Q4 2023 [10][11] - The net loss for Q4 2024 was $21.8 million, compared to a net loss of $42.2 million in Q4 2023, indicating improved financial performance [14][17] - Research and development expenses increased to $42.6 million for Q4 2024 from $33.5 million in Q4 2023, primarily due to costs associated with rosnilimab and other candidates [14][17] Clinical Development Updates - Rosnilimab achieved statistical significance on primary and key secondary endpoints in the Phase 2b trial for rheumatoid arthritis, with 69% of treated patients achieving low disease activity [5][10] - Phase 1 trials for ANB033 and ANB101 are progressing as planned, with ANB101 set to initiate this quarter [2][4] - An exclusive global license agreement with Vanda Pharmaceuticals was announced for imsidolimab, an IL-36R antagonist, which includes potential future milestone payments and royalties [4][10] Asset Portfolio - The company is advancing its lead program, rosnilimab, in both rheumatoid arthritis and ulcerative colitis, with significant data expected in 2025 [2][4] - Other candidates in development include ANB033, a CD122 antagonist, and ANB101, a BDCA2 modulator, both in early-stage trials [6][12] - The collaboration with GSK has shown strong commercial performance, particularly with Jemperli, which reported $190 million in Q4 2024 sales [10][11]
Is AnaptysBio (ANAB) Stock Outpacing Its Medical Peers This Year?
ZACKS· 2025-02-13 15:41
Group 1 - AnaptysBio, Inc. (ANAB) has shown strong year-to-date performance, returning 22%, significantly outperforming the Medical sector average of 5% [4] - The Zacks Consensus Estimate for ANAB's full-year earnings has increased by 15.7% in the past quarter, indicating improved analyst sentiment and earnings outlook [4] - AnaptysBio, Inc. is ranked 2 (Buy) in the Zacks Rank, which highlights stocks with characteristics likely to outperform the market in the near term [3] Group 2 - AnaptysBio, Inc. is part of the Medical - Biomedical and Genetics industry, which consists of 510 companies and is currently ranked 66 in the Zacks Industry Rank [6] - The Medical - Biomedical and Genetics industry has an average year-to-date return of 12.3%, indicating that ANAB is performing better than its industry peers [6] - Another outperforming stock in the Medical sector is AtriCure (ATRC), which has returned 38.6% year-to-date and also holds a Zacks Rank of 2 (Buy) [5][7]
AnaptysBio (ANAB) Surges 30.5%: Is This an Indication of Further Gains?
ZACKS· 2025-02-13 11:16
Core Viewpoint - AnaptysBio, Inc. shares experienced a significant rally of 30.5% following positive results from a mid-stage study of its investigational candidate, rosnilimab, for moderate-to-severe rheumatoid arthritis, despite a prior 17% loss over the past four weeks [1][2]. Company Performance - AnaptysBio's stock closed at $16.15 after notable trading volume [1]. - The company is expected to report a quarterly loss of $1.61 per share, reflecting a year-over-year change of -1.3%, with anticipated revenues of $10.17 million, representing a 12.8% increase from the previous year [3]. Study Results - Rosnilimab met its primary endpoint in the phase IIb RENOIR study for rheumatoid arthritis, achieving statistical significance at one dose and numerical superiority across all doses at week 12 [2]. - The study also achieved key secondary endpoints, with the highest responses recorded at week 14, despite elevated placebo rates [2]. - Full 28-week data from the RA study is expected to be shared in Q2 2025, and top-line data for ulcerative colitis is anticipated in Q4 2025 [2]. Earnings Estimates - The consensus EPS estimate for AnaptysBio has been revised 5.4% higher over the last 30 days, indicating a positive trend that may lead to price appreciation [4]. - The stock currently holds a Zacks Rank of 2 (Buy), suggesting potential for further strength [4]. Industry Context - AnaptysBio operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Pacira, has also shown strong performance with a 32.6% return over the past month [4]. - Pacira's consensus EPS estimate has increased by 4.1% to $0.85, although this reflects a year-over-year change of -4.5% [5].
AnaptysBio (ANAB) Update / Briefing Transcript
2025-02-12 14:32
Summary of Anaptis Bio Conference Call on Rozolumab Phase 2b Trial Results Company and Industry - **Company**: Anaptis Bio - **Industry**: Biotechnology, specifically focusing on autoimmune diseases, particularly Rheumatoid Arthritis (RA) Core Points and Arguments 1. **Strategic Focus**: Anaptis Bio aims to develop innovative antibodies to treat autoimmune diseases with high unmet needs, highlighting Rozolumab as a key program targeting PD-1 co-inhibitory receptors on activated T cells [3][100] 2. **Positive Trial Results**: The Phase 2b trial for Rozolumab in RA showed statistically significant results, with approximately 70% of treated patients achieving low disease activity (LDA) at week 14, the highest response rate reported in similar studies [5][102] 3. **Safety Profile**: Rozolumab demonstrated a favorable safety and tolerability profile, with no severe adverse events reported and only mild to moderate adverse events observed [13][14] 4. **Efficacy Metrics**: The primary endpoint (DAS28 CRP) was statistically significant at week 12, with continued improvement noted at week 14. The results showed comparable or superior efficacy to existing RA treatments [18][20][22] 5. **Patient Population**: The trial included a balanced mix of approximately 60% bio-naive and 40% bio-experienced patients, ensuring diverse representation [8][9] 6. **Long-term Efficacy**: Early data suggests that responses may deepen over time, with sustained improvements in ACR50 and ACR70 responses observed through week 28 [24][25] 7. **Market Potential**: The RA market is valued at approximately $20 billion globally, with a significant portion of revenue generated from bio-experienced patients, indicating a strong need for new therapies [27][28] 8. **Future Trials**: Anaptis Bio is optimistic about the ongoing Phase II trial for ulcerative colitis (UC), leveraging the positive safety and efficacy data from the RA trial [28][30] Other Important Content 1. **Translational Data**: Initial findings indicate a significant reduction in PD-1 high T cells and a 50% decrease in CRP levels in Rozolumab-treated patients, suggesting a broader impact on inflammation beyond T cell targeting [15][17][29] 2. **Financial Position**: Anaptis Bio has a strong cash runway through 2027, allowing for the completion of ongoing trials without immediate need for additional capital [30] 3. **Collaboration with GSK**: The company has a financial collaboration with GSK that could yield significant revenue, further strengthening its financial outlook [30][31] 4. **Regulatory Strategy**: The company plans to focus on completing the UC study before moving into Phase III trials for either RA or UC, emphasizing the need for a strategic approach to commercialization [83][88] This summary encapsulates the key points discussed during the conference call, highlighting the promising results of Rozolumab in treating RA and the strategic direction of Anaptis Bio in the biotechnology industry.
Anaptys Announces Rosnilimab Achieved Positive Results in RA Phase 2b Trial and Highest Ever Reported CDAI LDA Response Over 6 Months
Globenewswire· 2025-02-12 12:30
Core Insights - AnaptysBio, Inc. announced statistically significant Week 12 data from the Phase 2b RENOIR trial for rosnilimab, a treatment for moderate-to-severe rheumatoid arthritis (RA) [1][4][9] - Rosnilimab demonstrated a favorable safety profile, with adverse event rates similar to placebo [1][12][13] Group 1: Trial Overview - The Phase 2b RENOIR trial involved 424 patients with moderate-to-severe RA, assessing the efficacy, safety, and pharmacokinetics of rosnilimab [2][4] - Patients were randomized to receive different doses of rosnilimab or placebo, with primary and secondary endpoints evaluated at Weeks 12 and 14 [3][4] Group 2: Efficacy Results - Rosnilimab achieved its primary endpoint with a mean change from baseline in DAS-28 CRP at Week 12 for all doses compared to placebo [4][7] - Key secondary endpoints, including ACR20, ACR50, and CDAI LDA, showed statistical significance at Week 12, with 69% of patients achieving CDAI LDA at Week 14 [5][7][10] Group 3: Pharmacological Activity - Translational blood biomarker data indicated a robust pharmacological effect, with a ~90% reduction in PD-1 T cells and a ~50% reduction in PD-1+ T cells observed in rosnilimab-treated patients [6][8] - The treatment resulted in a favorable T cell composition and a ~50% reduction in mean CRP levels, indicating effective inflammation control [6][8] Group 4: Safety Profile - The safety data through Week 12 showed that 48% of patients on 100mg Q4W, 45% on 400mg Q4W, and 36% on 600mg Q2W experienced any adverse events, comparable to 34% in the placebo group [12][13] - No malignancies or major adverse cardiovascular events were reported, and the incidence of serious infections was similar to placebo [13][14] Group 5: Future Outlook - Full Week 28 data and additional translational data are expected in Q2 2025, with top-line data for ulcerative colitis anticipated in Q4 2025 [7][9][20] - The company aims to address the unmet need for innovative RA therapies, highlighting the potential of rosnilimab to provide durable relief and disease modification [11][14]
Anaptys to Announce Top-line Data from Phase 2b Trial of Rosnilimab, a PD-1 Depleter and Agonist, in Rheumatoid Arthritis on Feb. 12, 2025
Globenewswire· 2025-02-11 22:30
SAN DIEGO, Feb. 11, 2025 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, will host an investor call and live webcast to review top-line data from the global Phase 2b RENOIR clinical trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis on Wednesday, Feb. 12, 2025, at 8:30am ET / 5:30am PT. A live webcast of the call will be available on the ...
Anaptys to Present at the Guggenheim SMID Cap Biotech Conference
Globenewswire· 2025-02-03 21:15
SAN DIEGO, Feb. 03, 2025 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that Daniel Faga, president and chief executive officer of Anaptys, will present at the Guggenheim SMID Cap Biotech Conference on Wednesday, Feb. 5, 2025 at 1:00pm ET / 10:00am PT. A live webcast of the presentation will be available on the investor section of the Anaptys website at http://ir.anaptysbio.com/events. A re ...
Vanda Pharmaceuticals and Anaptys Announce Exclusive Global License Agreement for Vanda to Develop and Commercialize Imsidolimab, an IL-36R Antagonist
Newsfilter· 2025-02-03 12:30
Imsidolimab has successfully completed two global Phase 3 studies in Generalized Pustular PsoriasisVanda expects to immediately begin preparing BLA and MAA applications for the US and EUAnaptys to receive $15 million from Vanda, comprised of a $10 million upfront payment and $5 million for existing drug supplyAnaptys to receive a 10% royalty on global net sales of imsidolimab WASHINGTON and SAN DIEGO, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) and AnaptysBio, Inc. (An ...
How AnaptysBio (ANAB) Stock Stands Out in a Strong Industry
ZACKS· 2025-01-13 15:46
Company Summary - AnaptysBio, Inc. (ANAB) is currently positioned as an intriguing investment choice due to solid earnings estimate revisions and a favorable Zacks Rank of 2 (Buy) [1][4]. - Over the past month, the current quarter earnings estimates have improved from a loss of $1.63 per share to a loss of $1.61 per share, while the current year estimates have narrowed from a loss of $6.10 per share to a loss of $6.08 per share [4]. Industry Summary - The Medical - Biomedical and Genetics industry is experiencing positive trends, reflected in its Zacks Industry Rank of 63 out of more than 250 industries, indicating a strong position compared to other segments [2]. - The overall strength of the industry suggests that rising trends may benefit multiple securities within this sector, making it an attractive area for investment [2][5].