Immuno-oncology
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Bristol-Myers Stock Up as Q4 Earnings and Revenues Beat Estimates
ZACKS· 2026-02-05 16:51
Core Insights - Bristol-Myers Squibb Company (BMY) reported fourth-quarter 2025 adjusted earnings per share (EPS) of $1.26, exceeding the Zacks Consensus Estimate of $1.15, but down from $1.67 in the same quarter last year [1] - Total revenues reached $12.5 billion, surpassing the Zacks Consensus Estimate of $12.25 billion, and reflecting a 1% increase from the previous year [1] - The stock price increased following the better-than-expected quarterly results [1] Financial Performance - BMY's shares have increased by 28.5% over the past six months, while the industry has grown by 43.8% [2] - U.S. revenues remained flat year over year at $8.56 billion, while international revenues rose by 5% to $3.94 billion [3] - The Growth Portfolio revenues increased by 16% to $7.39 billion, primarily driven by immuno-oncology drugs like Opdivo [6][7] - The Legacy Portfolio revenues decreased by 15% to $5.11 billion, impacted by generic competition on key drugs, despite an 8% increase in Eliquis sales to $3.45 billion [11] Key Drug Performance - Opdivo sales increased by 9% year over year to $2.69 billion, surpassing estimates [8] - Yervoy contributed $810 million, up 20% year over year, and Reblozyl sales surged 22% to $666 million [9] - Breyanzi sales rose by 49% to $392 million, while Camzyos sales skyrocketed by 59% to $353 million [10] Cost and Margin Analysis - Adjusted gross margin decreased to 71.9% from 74% in the previous year due to a change in product mix [14] - Adjusted research and development expenses declined by 8% to $2.56 billion, and adjusted marketing, selling, and administrative expenses decreased by 1% to $2.09 billion [15] Future Guidance - For 2026, BMY provided revenue guidance of $46-$47.5 billion, supported by the Growth Portfolio's strong performance [17] - The company expects adjusted earnings to be in the range of $6.05-$6.35 for the full year, with the Zacks Consensus Estimate for 2026 EPS at $6.08 [17] Pipeline Updates - In December 2025, the FDA approved Breyanzi for adult patients with relapsed or refractory marginal zone lymphoma [18] - A supplemental biologics license application for Opdivo in combination with other drugs for Hodgkin lymphoma is under priority review, with a decision expected by April 8, 2026 [19]
New Data Demonstrate CD47 Expression Level Helps Predict Response to ALX Oncology's Evorpacept in Combination with Ziihera (zanidatamab-hrii) in Advanced HER2-Positive Breast Cancer
Globenewswire· 2026-01-30 13:15
Core Insights - ALX Oncology announced new data from a Phase 1b/2 clinical trial evaluating the investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals' ZIIHERA® for metastatic breast cancer, reinforcing CD47 as a predictive biomarker for treatment response [1][2] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with its lead candidate evorpacept showing potential as a cornerstone therapy in immuno-oncology [5] Clinical Trial Findings - The Phase 1b/2 trial demonstrated promising anti-tumor activity and a manageable safety profile, with a confirmed objective response rate of 56% and a median progression-free survival of 7.4 months in heavily pretreated HER2-positive breast cancer patients [2][3] - Additional exploratory analysis indicated that responses were primarily observed in patients with higher CD47 expression, supporting the predictive biomarker role of CD47 [3] Future Directions - The company plans to adopt a biomarker-driven approach for patient selection in future trials, particularly for combinations of evorpacept with HER2-targeted agents, and is confident in the ongoing ASPEN-09-Breast Phase 2 trial [2]
GT Biopharma(GTBP) - Prospectus
2026-01-21 21:15
As filed with the Securities and Exchange Commission on January 21, 2026. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GT BIOPHARMA, INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 2834 94-1620407 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) N/A (415) 919-4040 ( ...
BioNTech (NasdaqGS:BNTX) FY Earnings Call Presentation
2026-01-13 22:15
COVID-19 Vaccine Impact - BioNTech distributed over 5 billion COVID-19 vaccine doses to over 180 countries and territories[7, 11] - A real-world study of 27 million adults showed a 74% lower risk of death from severe COVID-19 over 45 months in vaccinated individuals[11] - BioNTech maintained leadership with over 50% market share in the global COVID-19 vaccine market during the fall 2025 vaccination season[9, 11] Financial Performance and Strategy - BioNTech expects its revenues for the full 2025 financial year to be in the range of €2600 - €2800 million[9] - BioNTech has €172 billion in cash, cash equivalents, and securities as of December 31, 2025[9, 17] - BioNTech anticipates a modest decline in Comirnaty revenues in 2026 compared to 2025[18] Oncology Pipeline and Development - BioNTech has over 25 ongoing Phase 2 & 3 oncology trials[7, 9] - There are 12+ combination trials with chemotherapy and 10+ novel-novel combinations trials ongoing with Pumitamig[42] - Gotistobart Phase 3 data shows a 54% reduction in the risk of death compared with docetaxel in CPI-Treated Squamous NSCLC[62]
Oxford BioTherapeutics Enters into a Strategic Collaboration with GSK to Discover Novel Targets for Antibody-Based Therapeutics for the Treatment of Cancer
Globenewswire· 2025-12-10 07:00
Core Insights - Oxford BioTherapeutics (OBT) has announced a multi-year collaboration with GSK to develop novel antibody-based therapeutics for cancer treatment [1][8] - The collaboration leverages OBT's OGAP®-Verify discovery platform for identifying oncology targets, which will be validated through joint research efforts [2][8] - OBT will receive an undisclosed upfront payment from GSK, along with potential milestone payments and royalties on net sales of resulting products [3][8] Company Overview - OBT is a clinical stage oncology company focused on developing first-in-class antibody-based therapies, including bispecific antibodies and antibody-drug conjugates (ADCs) [5][9] - The company aims to address significant unmet needs in cancer therapy through its innovative drug development approach [5][6] Technology and Development - The OGAP®-Verify platform enhances the sensitivity and specificity of oncology target identification, accelerating the validation of human targets for drug development [6][8] - OBT's lead clinical program, OBT076, targets advanced or refractory solid tumors, with a focus on cancers where CD205 is overexpressed [7][8] Strategic Partnerships - The collaboration with GSK marks OBT's second major partnership with a leading pharmaceutical company in 2025, highlighting the recognition of its discovery platform's potential [4][8] - OBT has previously established partnerships with other major companies, including Roche and Boehringer Ingelheim, validating its capabilities in oncology [8][9]
Crescent Biopharma (:) Partnerships / Collaborations Transcript
2025-12-04 14:02
Crescent Biopharma Conference Call Summary Company Overview - **Company**: Crescent Biopharma - **Focus**: Development of innovative therapies in oncology, particularly in immuno-oncology (IO) and antibody-drug conjugates (ADCs) [2][4] Key Industry Insights - **Market Opportunity**: The oncology market is valued at over $100 billion, with significant potential for innovative therapies [12][44] - **Partnership**: Crescent has formed a strategic partnership with Kelun-Biotech, a leading Chinese biotech company, to advance their pipeline and expand their market reach [9][10] Core Points and Arguments Pipeline Development - **CR001**: A PD-1 VEGF bispecific antibody with the potential to replace Keytruda as a foundational IO therapy. Phase 1/2 studies are set to begin in Q1 2027 [6][7] - **CR002**: A PD-1 topo ADC expected to enter clinical trials in mid-2026 [7][15] - **CR003 (SKB105)**: An integrin beta-6 topo ADC, also on track for early 2026 trials through the partnership with Kelun-Biotech [10][16] Partnership with Kelun-Biotech - **Collaboration Benefits**: The partnership allows for parallel development of CR001 and SKB105, enhancing the clinical data generation across both Western and Chinese patient populations [10][11] - **Kelun's Capabilities**: Kelun-Biotech has a robust pipeline with over 10 clinical-stage assets and established ADC capabilities, which complements Crescent's offerings [9][10] Clinical Strategy - **Combination Studies**: Crescent plans to explore combinations of CR001 with ADCs from both its own pipeline and Kelun's, aiming for multiple clinical data readouts by the end of 2027 [11][31] - **Focus on Key Indications**: The company is targeting thoracic, gastrointestinal, gynecologic, and head and neck cancers, with a strong emphasis on lung cancer due to its large market potential [12][14] Financial Position - **Capital Raise**: Crescent has successfully raised $185 million, positioning the company well for upcoming clinical milestones [8][12] Additional Important Insights - **Innovative Mechanism**: CR001 is designed to replicate the pharmacology of ivonescimab, which has shown promising results in clinical trials, indicating a strong potential for success [21][22] - **Differentiation in ADCs**: Crescent's ADCs, particularly CR002 and CR003, are designed to be best-in-class with unique payloads and mechanisms that enhance efficacy and safety [33][40] - **Regulatory Strategy**: The company is focused on efficient trial designs to accelerate the path to market, leveraging existing clinical data to inform their strategies [26][27] Conclusion Crescent Biopharma is strategically positioned in the oncology market with a robust pipeline and a strong partnership with Kelun-Biotech. The company is focused on innovative therapies that leverage unique mechanisms of action, aiming to deliver transformative treatments for cancer patients. The upcoming clinical trials and data readouts in 2027 are critical milestones for Crescent's growth and market presence [44][45]
Compugen (NasdaqCM:CGEN) 2025 Conference Transcript
2025-11-11 21:20
Summary of Compugen Conference Call Company Overview - **Company**: Compugen (NasdaqCM:CGEN) - **Industry**: Biotechnology, specifically in immuno-oncology - **Key Focus**: Computational AI-based target discovery for new drug targets Core Points and Arguments 1. **Unique Computational Platform**: Compugen utilizes a validated computational platform to identify first-in-class drug targets in immuno-oncology, including TIGIT and PVRIG [3][4] 2. **Pipeline Assets**: The company has two wholly owned assets, COM-902 (TIGIT blocker) and COM-701 (anti-PVRIG antibody), and has licensed COM-902 to AstraZeneca for use in their bispecific therapy [4][34] 3. **Clinical Trials**: - COM-701 is being evaluated in recurrent platinum-sensitive ovarian cancer, with promising early clinical signals observed, particularly in PD-1 negative patients [5][6][7] - The trial design includes an adaptive approach with a control arm expected to show a median progression-free survival (PFS) of 5.5 months [11][12] - Results from the trial are anticipated in Q1 2027 [12][18] 4. **Biological Mechanism**: PVRIG inhibition is believed to significantly increase T cell presence in the tumor microenvironment, which is critical for efficacy in ovarian cancer [6][9] 5. **Regulatory Considerations**: A three-month improvement in PFS over the control arm could initiate discussions with the FDA regarding accelerated approval due to the unmet need in this patient population [23][24] 6. **Partnership with AstraZeneca**: Compugen has received $30 million in milestones from AstraZeneca and is eligible for an additional $170 million, along with mid-single digit tiered royalties from potential sales of volrustomig [42][44] Additional Important Information 1. **Competitive Landscape**: Compugen is currently the only company with a PVRIG targeting antibody in clinical trials, following GSK's discontinuation of their PVRIG program [28][31] 2. **TIGIT Development**: The company has paused new trials for COM-902 due to ongoing debates in the community regarding TIGIT therapies, but sees future potential based on AstraZeneca's promising results [34][38] 3. **IL-18BP Asset**: Compugen has licensed an IL-18BP blocker to Gilead, which is currently in phase one trials, with a unique mechanism to activate IL-18 in the tumor microenvironment [50][51] 4. **Cash Runway**: Compugen has a cash runway of approximately two years, extending into Q3 2027, allowing for the continuation of current trials without additional income [61] Conclusion Compugen is positioned as a pioneer in computational drug discovery within the immuno-oncology space, with a robust pipeline and strategic partnerships that could lead to significant advancements in cancer treatment. The upcoming trial results and ongoing collaborations will be critical in shaping the company's future trajectory and market position.
Xilio Therapeutics (NasdaqGS:XLO) Earnings Call Presentation
2025-11-10 21:30
Vilastobart Clinical Data and Opportunity - Vilastobart, in combination with atezolizumab, showed a 40% Overall Response Rate (ORR) in MSS mCRC patients without liver metastases and with high plasma TMB[30, 42] - 63% of plasma TMB-evaluable patients had high plasma TMB (≥10 mutations/Mb) in the Phase 2 trial, including all TMB-evaluable responders[32, 33, 42] - A statistically significant correlation (p=0.05) was observed between plasma TMB status and response to vilastobart plus atezolizumab[33, 42] - The combination of vilastobart and atezolizumab demonstrated a differentiated safety profile, with a low discontinuation rate of 5% and only 7% of patients experiencing colitis of any grade[35, 36, 42] Market and Competitive Landscape - Approximately 95% of mCRC patients are MSS, and standard of care in 3L+ provides minimal benefit (1-6% ORR)[23] - Real-world data indicates that approximately 55% of patients with MSS CRC have high plasma TMB, which is substantially higher than historically reported with tissue-based TMB assays[28, 42] - Next-generation anti-CTLA-4 agents in development show promising clinical efficacy in MSS mCRC, with ORRs ranging from 8-29% and discontinuation rates due to AEs up to ~30%[21] Technology and Pipeline - Xilio's clinically-validated platform technology is being applied across diverse mechanisms and architectures, including antibodies, cytokines, bispecifics, and T cell engagers[13, 14] - Efarindodekin Alfa (tumor-activated IL-12) demonstrated promising clinical efficacy with a generally well-tolerated safety profile in Phase 1 in patients with advanced solid tumors[44] - Masked T cell engager programs demonstrated potent anti-tumor activity with favorable tolerability across a diverse range of targets in preclinical models[50, 51, 52] Financial Outlook and Milestones - The company anticipates a cash runway into Q1 2027, including a $175 million development milestone received under the Gilead license in Q4 2025[53] - Anticipated milestones include reporting updated Phase 2 data for vilastobart in combination with atezolizumab in metastatic MSS mCRC in 1H 2026 and IND submissions for at least two masked T cell engager programs in 2027[53]
GT Biopharma(GTBP) - Prospectus
2025-10-24 20:15
FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GT BIOPHARMA, INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 2834 94-1620407 (Primary Standard Industrial Classification Code Number) As filed with the Securities and Exchange Commission on October 24, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Approximate date of commencement of proposed sale to the pub ...
Compugen (CGEN) FY Conference Transcript
2025-09-05 12:00
Summary of Compugen (CGEN) FY Conference Call - September 05, 2025 Company Overview - **Company**: Compugen Ltd. - **Industry**: Clinical-stage immunotherapy, specifically immuno-oncology - **Focus**: Utilizes AI/ML-driven predictive tools for discovering novel drug targets - **Key Collaborations**: Partnerships with AstraZeneca and Gilead [1][3] Core Points and Arguments Development Strategy - Compugen has a rich pipeline with two fully owned clinical assets: COM701 (PVRIG antibody) and COM902 (anti-TIGIT antibody) [3][4] - COM902 is licensed to AstraZeneca for use in a bispecific molecule, relvegostomig, currently in Phase III trials [4] - Gilead is developing GS0321, a potential first-in-class antibody identified through Compugen's Unigen™ platform, now in Phase I study [4][24] Computational Platform - Unigen™ - Unigen™ focuses on target discovery in oncology, identifying novel drug targets to enhance clinical testing options [5] - The platform has been validated through successful transitions from computational predictions to clinical testing [5] COM701 and Ovarian Cancer - COM701 targets PVRIG, which is highly expressed in ovarian cancer, particularly in less inflamed tumor types [6][7] - The MAIA ovarian cancer study aims to evaluate COM701 as a maintenance treatment for platinum-sensitive patients, with a focus on improving progression-free survival [8][14] - Current standard of care for these patients is limited, creating an unmet need that COM701 could address [10][12] Clinical Trial Design - The MAIA study is randomized and blinded, comparing COM701 monotherapy to placebo [14] - Interim analysis expected in H2 2026, with a goal to show improvement in progression-free survival by more than three months [15] TIGIT Development Landscape - Compugen and AstraZeneca continue to evaluate relvegostomig despite challenges faced by other companies in the TIGIT space [20][21] - The unique characteristics of their TIGIT antibody class, which does not bind FC receptors, may contribute to a favorable safety profile [21][22] Financials and Future Outlook - Compugen reported approximately $94 million in cash as of June, providing a runway into 2027 without relying on royalties or milestones from collaborations [31] - Upcoming catalysts include ESMO presentations and readouts from ongoing studies, particularly in the TIGIT landscape [30] Additional Important Content - The partnership with Gilead includes a deal structure worth up to $850 million, with Compugen leading the Phase I study for GS0321 [24][25] - The mechanism of action for GS0321 involves blocking IL-10 binding protein to unleash the activity of IL-10 in the tumor environment [27][28] - The company is optimistic about the potential of COM701 and its ability to prolong the time from platinum-sensitive status to relapse in ovarian cancer patients [12][30]