BridgeBio Initiates Long Term Debt Management Strategy and Announces Proposed Offering of Convertible Senior Notes to Refinance Senior Secured Debt

On February 24, 2025 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (the "Company," "we" or "BridgeBio") reported that it intends to offer, subject to market conditions and other factors, $500 million aggregate principal amount of convertible senior notes due 2031 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, BridgeBio, FEB 24, 2025, View Source [SID1234650485]). In connection with the offering, the Company expects to grant the initial purchasers an option to purchase up to an additional $75 million aggregate principal amount of notes.

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The Company intends to use a portion of the net proceeds from the offering to repay all outstanding borrowings under and terminate its Financing Agreement, dated as of January 17, 2024, with the lenders party thereto and Blue Owl Corporation, as administrative agent, as amended (the "Financing Agreement"), and pay any fees related thereto. The termination of the Financing Agreement, which accounted for approximately $51.5 million of cash paid for interest in 2024 and contains various restrictive covenants, will provide the Company with reduced pro forma interest expense and greater operational flexibility. The Company intends to use up to $50 million of any remaining net proceeds from the offering to repurchase shares of its common stock from certain purchasers of the notes in privately negotiated transactions effected through one or more of the initial purchasers or an affiliate thereof concurrently with the pricing of the notes (such transactions, the "share repurchases"), together, if necessary, with cash on hand. The Company expects to use any remaining net proceeds from the offering for general corporate purposes.

The Company expects the purchase price per share of its common stock in the share repurchases to equal the last reported sale price per share of its common stock on the Nasdaq Global Select Market as of the date of the pricing of the notes. The share repurchases could increase (or reduce the size of any decrease in) the market price of the Company’s common stock prior to, concurrently with or shortly after the pricing of the notes, and could result in a higher effective conversion price for the notes. The Company cannot predict the magnitude of such market activity or the overall effect it will have on the market price of the notes and/or the market price of the Company’s common stock.

The final terms of the notes, including the initial conversion rate, interest rate and certain other terms, will be determined at the time of pricing. The notes will bear interest semi-annually and will mature on March 1, 2031, unless earlier converted, redeemed or repurchased. Prior to December 2, 2030, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. Thereafter, the notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. The notes will be convertible at the option of the holders, subject to certain conditions and during certain periods, into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, with the form of consideration determined at the Company’s election.

The Company may not redeem the notes prior to March 6, 2028. On or after March 6, 2028 and on or before the 41st scheduled trading day immediately before the maturity date of the notes, the Company may redeem for cash all or any portion of the notes, at its option at any time, and from time to time, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for a specified period of time and certain other conditions are satisfied. The redemption price will be equal to 100% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. Holders of the notes will have the right to require the Company to repurchase all or a portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of certain events.

When issued, the notes will be the Company’s senior unsecured obligations and will rank senior in right of payment to any of the Company’s unsecured indebtedness that is expressly subordinated in right of payment to the notes; equal in right of payment to any of the Company’s unsecured indebtedness that is not so subordinated; effectively junior in right of payment to any of the Company’s secured indebtedness and obligations, to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of the Company’s subsidiaries.

The notes and the shares of common stock issuable upon conversion of the notes, if any, are not being registered under the Securities Act, or the securities laws of any other jurisdiction. The notes and the shares of common stock issuable upon conversion of the notes, if any, may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Myriad Genetics Partners with PATHOMIQ to add Artificial Intelligence Technology Platform to its Oncology Portfolio

On February 24, 2025 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, and PATHOMIQ, Inc., a developer of artificial intelligence (AI)-enabled prognostic and predictive tests for advancing access to personalized medicine and empowering treatment decisions, reported that they have entered into a strategic collaboration for Myriad to exclusively license PATHOMIQ_PRAD, PATHOMIQ’s AI technology platform for prostate cancer, in the United States (Press release, Myriad Genetics, FEB 24, 2025, View Source [SID1234650509]).

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Machine learning and AI-enabled diagnostics are transforming the way clinicians approach cancer patient care. Adding PATHOMIQ_PRAD to Myriad’s Oncology Solutions allows Myriad to provide urologist and radiation oncologists with molecular and AI-powered testing solutions to inform decisions both before treatment at the time of biopsy for active surveillance and following surgery or radiation treatment. This complements Myriad’s existing offerings of combined germline and comprehensive tumor profiling as recommended by NCCN guidelines for prostate cancer care.

"Along with our Prolaris Prostate Cancer Prognostic Test, we are pleased to leverage PATHOMIQ’s prognostic and predictive capabilities across different phases of the patient journey in prostate cancer," said George Daneker, Jr., MD, President and Chief Clinical Officer, Oncology, Myriad Genetics. "Having both genetic and morphologic insights at the time of biopsy combined with the enhanced ability to predict disease recurrence after initial therapy can lead to more informed treatment decisions and enhance the potential for better patient outcomes. This partnership is the latest step in the strategic expansion of Myriad’s oncology portfolio. Our molecular science expertise, combined with the latest in machine learning and AI, will uniquely position Myriad to deliver higher-quality insights for patients and clinicians in the fight against cancer."

PATHOMIQ’s AI-technology platform decodes hidden information from complex morphological structures across all landscapes of cancer pathology to quickly and efficiently deploy new use cases to predict patient outcome, treatment response, and genotype mutations. This image-based technology can deliver results in one to two days after receiving the digital images from the patient’s sample.

"I am excited to have co-developed, with the PATHOMIQ team, the PATHOMIQ-PRAD AI model for prostate cancer treatment response prediction and identification of high-risk prostate cancer patients who will experience early metastasis post Radical Prostatectomy," said Ashutosh K. Tewari, Chairman, Milton and Carroll Petrie Department of Urology at the Icahn School of Medicine at Mt Sinai. "The AI model has achieved high prediction accuracy and outperformed some of the currently used markers in both Caucasian and African American patient cohorts for a much-improved patient outcome."

In addition to expanding Myriad’s prostate cancer testing portfolio to include post-surgical treatment testing solutions, the collaboration with PATHOMIQ is also envisioned to accelerate the timelines for meeting Simon level 1 evidence for both Prolaris and PATHOMIQ_PRAD. While the current PATHOMIQ_PRAD model is specific for use in patients with prostate cancer after surgery, the underlying foundational model provides opportunities for applications in virtually all solid tumor cancers that are diagnosed through a biopsy with H&E staining.

"Our collaboration with Myriad, a leader in cancer diagnostic tests, will help to advance precision medicine and improve prostate cancer disease outcomes," said Rajat Roy, CEO and co-founder of PATHOMIQ. "Our AI-powered model has been successfully validated across multiple medical institutions and pharmaceutical partners. Combining Myriad’s extensive clinical expertise and broad customer reach with PATHOMIQ’s AI technology platform will allow more personalized treatment options for clinicians and their patients."

Paul J. Diaz, President and CEO of Myriad, adds "PATHOMIQ’s technology platform, together with Myriad’s infrastructure and commercial capabilities allows for an accelerated pace of innovation to bring advanced diagnostic products to market that are clinically validated with faster turnaround times and at a lower cost."

Myriad intends to commercially launch its first AI-driven prostate cancer clinical test later this year.

Crinetics Pharmaceuticals Appoints Tobin Schilke as Chief Financial Officer

On February 24, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported the appointment of Tobin "Toby" Schilke as chief financial officer, effective February 28, 2025 (Press release, Crinetics Pharmaceuticals, FEB 24, 2025, View Source [SID1234650469]). Mr. Schilke is a seasoned biopharma executive with over 25 years of global pharmaceutical experience. In prior roles, his leadership was instrumental in transforming several biotech companies from R&D-focused entities into fully integrated commercial organizations.

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"I am excited to welcome Toby to our senior leadership team during this transformational stage of our evolution into a global pharmaceutical company," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "Toby’s deep finance experience in commercial-stage global pharmaceutical companies and emerging biotech is essential as we prepare for our first commercial launch and advance numerous promising candidates through development. I would also like to thank Marc Wilson for his invaluable leadership and financial stewardship during his tenure, guiding the company through critical phases of growth."

"I am honored to join Crinetics at such a pivotal time in the company’s journey and am deeply inspired by its mission to improve the lives of people living with endocrine-related conditions," said Mr. Schilke. "I look forward to collaborating with the Crinetics team and stakeholders to accelerate our growth objectives and create long-term value."

Prior to joining Crinetics, Mr. Schilke served as chief financial officer at Revance Therapeutics, where he oversaw finance, investor relations, IT, and technical operations for a public company with 650 employees, supporting the transformation to a commercial company with two product launches and over $700 million in cumulative revenue. Previously, Mr. Schilke served as Chief Financial Officer at Achaogen, where he built out the financial planning and analysis, accounting, procurement, information technology, and facilities management functions to support the approval and launch of the company’s first product. In these roles, Mr. Schilke successfully executed over $1.5 billion in equity, convertible debt, and structured debt financing, while also leading numerous partnerships and M&A deals. Earlier in his career, he spent more than a decade in increasing roles of responsibility at Roche/Genentech in corporate development, commercial finance, marketing and global operations. Mr. Schilke holds a bachelor’s degree in chemical engineering from Lafayette College, a master’s degree in chemical engineering from the University of California, Berkeley, and a master’s degree in business administration from Cornell University.

On March 10, 2025, the Company expects to grant Mr. Schilke 52,000 restricted stock units (RSUs) and a stock option to purchase 80,000 shares of common stock under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan"). The shares subject to the stock options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 successive equal monthly installments thereafter, subject to each employee’s continued employment with Crinetics on such vesting dates. The RSUs will vest over four years in equal annual installments beginning on the one-year anniversary of the applicable vesting commencement date, also subject to each employee’s continued employment with Crinetics on such vesting dates. The stock option and RSU awards are subject to the terms and conditions of the 2021 Inducement Plan and the terms and conditions of an applicable stock option award agreement or RSU award agreement covering the respective grant. The RSUs and stock option will be granted as an inducement material to Mr. Schilke entering into employment with Crinetics in accordance with Nasdaq Listing Rule 5635(c)(4).

Summit Therapeutics Reports Financial Results and Operational Progress for the Fourth Quarter and Twelve Months Ended December 31, 2024

On February 24, 2025 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported its financial results and provides an update on operational progress for the fourth quarter and year-ended December 31, 2024 (Press release, Summit Therapeutics, FEB 24, 2025, View Source [SID1234650486]).

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Operational & Corporate Updates

Operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:

In January 2023, we closed our Collaboration and License Agreement with Akeso Inc. (Akeso, HKEX Code: 9926.HK) for ivonescimab (SMT112), with which over 2,300 patients have been treated in clinical studies globally. Summit has rights to develop and commercialize ivonescimab in the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa while Akeso retains development and commercialization rights for the rest of the world, including China.
Since in-licensing ivonescimab, we have begun our development for ivonescimab in non-small cell lung cancer ("NSCLC"), specifically launching Phase III clinical trials in the following proposed indications:
HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI)
HARMONi-3: Ivonescimab combined with chemotherapy in first-line metastatic NSCLC patients
In addition, we have begun to activate clinical trial sites in the United States for a Phase III clinical study in the following proposed indication:
HARMONi-7: Ivonescimab monotherapy in first-line metastatic NSCLC patients with high PD-L1 expression
In October 2024, we completed enrollment in our HARMONi clinical trial. We expect to disclose topline results from HARMONi in mid-2025, depending upon maturation of the data per the protocol.
The U.S. Food and Drug Administration ("FDA") has granted Fast Track designation for the proposed use of ivonescimab in combination with platinum-based chemotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR mutation, who have experienced disease progression following EGFR-TKI therapy.
In the fourth quarter of 2024, we amended the HARMONi-3 protocol to, amongst other changes, include patients with both squamous and non-squamous histologies, significantly increasing the population of patients eligible for treatment in the proposed indication. Enrollment has begun in all regions for patients with squamous tumors; the protocol amendment is effective and enrollment has begun in United States for patients with non-squamous tumors.
Recently, we announced a clinical trial collaboration with Pfizer in which Pfizer will contribute multiple antibody drug conjugates (ADCs) to be evaluated in combination with ivonescimab in unique solid tumor settings. The goal of the collaboration is to accelerate the advancement of potentially landscape-changing therapeutic combinations, which seek to improve the standards of care for patients facing serious unmet needs.
Under the terms of the agreement, Summit will provide ivonescimab for use in the proposed studies, and Pfizer will be responsible for conducting the operations of the studies, including associated costs. The studies will be overseen by both Summit and Pfizer. Both parties retain their respective rights to their products. The studies combining ivonescimab with Pfizer’s vedotin ADCs are planned to begin in the middle of this year. Further details on the clinical trials will be announced at a later date.
We intend to explore further clinical development of ivonescimab in solid tumor settings outside of metastatic non-small cell lung cancer, Additionally, institutions with whom we have collaborated have begun opening investigator-sponsored trials across multiple oncology settings. We plan to review the data generated from these clinical trials as a part of our consideration for advancing our clinical development for ivonescimab beyond non-small cell lung cancer.
Financial Highlights

Cash and Cash Equivalents & Short-term Investments

Aggregate cash and cash equivalents and short-term investments were $412.3 million and $186.2 million at December 31, 2024 and December 31, 2023, respectively.
GAAP and Non-GAAP Research and Development (R&D) Expenses

GAAP R&D expenses according to generally accepted accounting principles in the U.S. ("GAAP") were $150.8 million for the full year of 2024, compared to $59.4 million for the full year of 2023.
Non-GAAP R&D expenses were $134.8 million for the full year of 2024, compared to $55.0 million for the full year of 2023.
GAAP and Non-GAAP General and Administrative (G&A) Expenses

GAAP G&A expenses were $60.5 million for the full year of 2024, compared to $30.3 million for the full year of 2023.
Non-GAAP G&A expenses were $25.5 million for the full year of 2024, compared to $20.6 million for the full year of 2023.
GAAP and Non-GAAP Operating Expenses

GAAP operating expenses were $226.3 million for the full year of 2024, compared to $610.6 million for the full year of 2023.
Non-GAAP operating expenses were $175.3 million for the full year of 2024, compared to $596.5 million for the full year of 2023. The decrease is primarily related to the decrease in acquired in-process R&D expenses of $505.9 million, offset by the increase in R&D expenses due to expansion of clinical studies and development costs related to ivonescimab and increases in people costs as we continue to build out our team.
GAAP and Non-GAAP Net Loss

GAAP net loss in the full year of 2024 and 2023 was $221.3 million or $(0.31) per basic and diluted share, and $614.9 million or $(0.99) per basic and diluted share, respectively.
Non-GAAP net loss in the full year of 2024 and 2023 was $170.3 million or $(0.24) per basic and diluted share, and $600.8 million or $(0.97) per basic and diluted share, respectively.
Use of Non-GAAP Financial Measures

This release includes measures that are not in accordance with U.S. generally accepted accounting principles ("Non-GAAP measures"). These Non-GAAP measures should be viewed in addition to, and not as a substitute for, Summit’s reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit’s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. For further information regarding these Non-GAAP measures, please refer to the tables presenting reconciliations of our Non-GAAP results to our U.S. GAAP results and the "Notes on our Non-GAAP Financial Information" that accompany this press release.

Fourth Quarter 2024 Earnings Call

Summit will host an earnings call this morning, Monday, February 24, 2025, at 9:00 am ET. The conference call will be accessible by dialing (800) 715-9871 (toll-free domestic) or (646) 307-1963 (international) using conference code 3934052. A live webcast and instructions for joining the call are accessible through Summit’s website www.smmttx.com. An archived edition of the webcast will be available on our website after the call.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days (Zhong, et al, SITC (Free SITC Whitepaper), 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 2,300 patients have been treated with ivonescimab in clinical studies globally.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3, and the Company has begun to activate clinical trial sites in the United States for HARMONi-7.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). Enrollment in HARMONi was completed in the second-half of 2024, and top-line results are expected to be announced in the middle of this year.

HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

In addition, Akeso has recently had positive read-outs in two single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC, HARMONi-A and HARMONi-2.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

CORRECTING and REPLACING Agenus’ BOT/BAL Selected for Two Presentations at Upcoming AACR IO Annual Meeting

On February 23, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported that BOT/BAL will be featured in two presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) IO Annual Meeting that will take place on February 23-26 in Los Angeles, California (Press release, Agenus, FEB 23, 2025, View Source [SID1234650450]). An oral presentation will highlight interim data from the ongoing Phase 2 study of botensilimab and balstilimab (BOT/BAL) in combination with MiNK Therapeutics’ iNKT cell therapy, AgenT-797, in patients with refractory (2L+) gastric cancer (NCT06251973). A Trial-in-Progress (TiP) poster will feature data from the ongoing Phase 1/2 study of BOT/BAL in first-line MSS colorectal cancer (NCT06268015).

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Presentation Details:

Abstract Title: First-line botensilimab and balstilimab optimization in microsatellite stable colorectal cancer (MSS-CRC) without liver metastasis (BBOpCo)

Session : Poster Session A

Session Date and Time: Monday, February 24th , 1:45-4:45 p.m. PST

Abstract Title: Biomarker analysis from phase 2 study of AgenT-797 (invariant natural killer T-cells), botensilimab (a Fc-enhanced CTLA-4 Inhibitor) with balstilimab (anti-PD-1) in PD-1 refractory gastroesophageal cancer (GEC)

Session : Proffered Papers, Session 2

Session Date and Time: Monday, February 24th , 1:39-1:45 p.m. PST