TCBP CEO Bryan Kobel to Participate on Cancer Progress Panel at 18th Annual European Life Sciences CEO Forum

On February 20, 2025 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) , a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported that its CEO will join the Cancer Progress Panel discussion on February 27th at 1:10 pm CET at the 18th Annual European Life Sciences CEO Forum, which will include HealthTech topics such as AI, convergence, and diagnostics (Press release, TC Biopharm, FEB 20, 2025, View Source [SID1234650431]).

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The forum will take place on the 26th – 27th of February 2025 at the Hilton Zurich Airport Hotel. The main programme for the 18th Annual ELSF will feature more than 12 hours of high-level keynotes and panel discussions.

Additionally, there will be a global company showcase of 50+ presentations by established public, private, emerging, and seed companies, offering innovative solutions and seeking investment and partnering opportunities. For more information about the 18th Annual European Life Sciences CEO Forum.

Bantam Pharmaceutical Announces Activation of First Phase 1 Clinical Trial Site at MD Anderson Cancer Center

On February 20, 2025 Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, reported the activation of its first clinical trial site at The University of Texas MD Anderson Cancer Center for its Phase 1 study evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas (Press release, Bantam Pharmaceutical, FEB 20, 2025, View Source [SID1234650429]). BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets mitochondrial homeostasis via the ATF4-Integrated Stress Response (ISR) pathway to treat aggressive tumors.

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"We are pleased to activate our first clinical site at MD Anderson Cancer Center, a world-renowned institution known for its leadership in cancer research and treatment," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "This represents a major milestone for our company as we transition from discovery into clinical development. Through its novel mechanism of action, BTM-3566 has the potential to deliver the tumor-killing potency of chemotherapy with the precision and selectivity of targeted therapies. We are excited to partner with MD Anderson and believe this collaboration reflects our shared commitment to advancing medical research and improving patient outcomes."

The Phase 1 clinical trial is a multicenter, open-label, dose-escalation and -expansion study. The study will evaluate the safety, tolerability, pharmacokinetics, anti-tumor, and pharmacodynamic effects of BTM-3566. Initial clinical data from the trial are expected in the second half of 2025.

Bantam remains dedicated to addressing the need for new treatments targeting aggressive tumors and looks forward to expanding the clinical trial to additional North American sites in the coming months.

For more information about the trial, visit ClinicalTrials.gov and search NCT number NCT06792734.

About BTM-3566

BTM-3566 is a novel, orally available small molecule designed to target a wide range of cancers, including both hematologic and solid tumors. Its initial clinical focus is on mature B-cell lymphomas, such as mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL). In preclinical studies, BTM-3566 demonstrated potent anti-cancer activity, driving significant tumor regression – and in many cases, complete tumor elimination – in tumor models resistant to standard treatments, including CAR-T cell therapy. BTM-3566 works by disrupting the mitochondrial function in tumor cells, triggering their natural cell death process (apoptosis). With its unique mechanism of action and strong preclinical data, Bantam also plans to expand clinical development into solid tumors, broadening its potential impact for patients with limited treatment options.

GRAIL Reports Fourth Quarter and Full Year 2024 Financial Results

On February 20, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported business and financial results for the fourth quarter and full year 2024 and provided business updates (Press release, Grail, FEB 20, 2025, View Source [SID1234650428]).

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Fourth quarter revenue grew 26% year-over-year to $38.3 million, and Galleri revenue grew 39% year over year to $31.6 million. Net loss for the quarter was $97.1 million, which includes amortization of Illumina acquisition-related intangible items of $34.6 million. Gross loss was $16.0 million. Non-GAAP adjusted gross profit was $17.9 million and non-GAAP adjusted EBITDA was $(84.0) million.1

For the full year, total revenue grew 35% year over year to $125.6 million, and Galleri revenue grew 45% year over year to $108.6 million. Net loss for the year was $2.0 billion, which includes goodwill and intangible assets impairment of $1.4 billion and amortization of Illumina acquisition-related intangible items of $138.3 million. Gross loss was $78.0 million. Non-GAAP adjusted gross profit was $57.8 million and non-GAAP adjusted EBITDA was $(483.5) million.1

Additionally, TRICARE Health Insurance recently added GRAIL’s Galleri multi-cancer early detection test as a covered benefit. The Galleri test will be covered for patients who are 50 years or older with an elevated risk for cancer. TRICARE is one of the largest health plans in the U.S. and serves active duty service members, National Guard and Reserve members, retirees and their families.

"2024 was a transformational year for GRAIL as we completed the separation from Illumina in June 2024, and completed study visits for our two registrational studies in July," said Bob Ragusa, Chief Executive Officer at GRAIL. "We executed a restructuring in the third and fourth quarters, and continue to focus on business efficiencies while also growing commercially. We plan to read out our registrational studies in 2025 and 2026 and complete our modular PMA submission in the first half of 2026."

For the three months ended December 31, 2024, as compared to the three months ended December 31, 2023, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $38.3 million, an increase of $7.9 million or 26%.
Net loss: Net loss was $97.1 million, an improvement of $90.5 million or 48%.
Gross loss: Gross loss was $16.0 million , an improvement of $2.7 million or 14%.
Adjusted gross profit1: Adjusted gross profit was $17.9 million, an increase of $2.6 million or 17%.
Adjusted EBITDA1: Adjusted EBITDA was $(84.0) million, an improvement of $39.4 million or 32%.
For the twelve months ended December 31, 2024, as compared to the twelve months ended December 31, 2023, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $125.6 million, an increase of $32.5 million or 35%.
Net loss: Net loss was $2.0 billion, an increase of $561.3 million or 38%, primarily driven by goodwill and intangible asset impairment.
Gross loss: Gross loss was $78.0 million, an improvement of $17.6 million or 18%.
Adjusted gross profit1: Adjusted gross profit was $57.8 million, an increase of $17.6 million or 44%.
Adjusted EBITDA1: Adjusted EBITDA was $(483.5) million, an improvement of $40.3 million or 8%.
Cash position: Cash, cash equivalents, restricted cash and short-term marketable securities totaled $766.8 million as of December 31, 2024.

Additional business highlights include:

Patient Reported Outcomes for GRAIL’s Galleri Multi-Cancer Early Detection Blood Test Published in Lancet Oncology. Analysis of patient reported outcomes from PATHFINDER indicate minimal patient distress associated with multi-cancer early detection (MCED) testing, and high overall satisfaction with the MCED test was reported across participant groups regardless of signal detection status and eventual diagnosis. Most participants reported they were "likely"/"very likely" to adhere to future guideline recommended screening tests as recommended by their healthcare provider.

GRAIL and Quest Diagnostics Announced Availability of GRAIL’s Galleri MCED Test Through the Quest Diagnostics Test Ordering System. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest’s Quantum laboratory portal and more than 900 electronic health record systems. More than 500,000 providers used the Quest connectivity system last year. The integration will help streamline the process of ordering the Galleri test and increase availability by allowing patients access to the test at any of the approximately 7,400 patient access points nationwide. Patients can now go directly to Quest without needing to bring a Galleri test kit to the blood draw appointment.

Conference Call and Webcast

A webcast and conference call will be held today, February 20, 2025, at 1:30 p.m. PT / 4:30 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL’s website at investors.grail.com.

A replay of the webcast will be available on GRAIL’s website for 30 days.

Jazz Pharmaceuticals to Participate in TD Cowen’s 45th Annual Health Care Conference

On February 20, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Company will participate in TD Cowen’s 45th Annual Health Care Conference. Company management will participate in a fireside chat on Wednesday, March 5, 2025, at 7:30 a.m. PT / 10:30 a.m. ET / 3:30 p.m. GMT (Press release, Jazz Pharmaceuticals, FEB 20, 2025, View Source [SID1234650427]).

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An audio webcast of the fireside chat will be available via the Investors section of the Jazz Pharmaceuticals website at View Source A replay of the webcasts will be archived on the website for 30 days.

Akeso Enrolled First Patient in The Phase III Clinical Trial of Ivonescimab in Combination with Chemotherapy for First-Line Treatment of Triple-Negative Breast Cancer

On February 20, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the company has successfully enrolled the first patient in its multicenter, randomized, double-blind Phase III clinical trial of ivonescimab in combination with chemotherapy for first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) (HARMONi-BC1/AK112-308) (Press release, Akeso Biopharma, FEB 20, 2025, View Source [SID1234650426]). Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody independently developed by the company.

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HARMONi-BC1/AK112-308 study is led by Professor Xu Binghe, a renowned breast cancer expert and academician of the Chinese Academy of Engineering, from the Cancer Hospital of the Chinese Academy of Medical Sciences. Preliminary efficacy data presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting demonstrated that ivonescimab combined with chemotherapy showed significant therapeutic efficacy and also exhibited a favorable safety profile, underscoring its clinical potential for the treatment of locally advanced or metastatic TNBC.

Akeso has strategically positioned ivonescimab within a comprehensive development plan, aiming to reshape the landscape of cancer immunotherapy and establish a new global standard of care. Ivonescimab, in combination with chemotherapy, has been approved in China for the treatment of EGFR-TKI-resistant, non-squamous NSCLC. The New Drug Application (sNDA) for ivonescimab monotherapy as a first-line treatment for PD-L1-positive NSCLC (in comparison to pembrolizumab) is currently under review and has been granted priority status in China.

Three international multicenter Phase III clinical trials, led by our partner Summit Therapeutics, are progressing efficiently or are being initiated:

The HARMONi study, an international multicenter Phase III clinical trial evaluating ivonescimab in combination with chemotherapy for non-squamous NSCLC with progression after third-generation EGFR-TKI treatment, has had patient enrollment completed and has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA),
The HARMONi-3 study, an international multicenter Phase III clinical trial comparing ivonescimab combined with chemotherapy as first-line treatment for both squamous and non-squamous NSCLC (versus pembrolizumab combined with chemotherapy),
The HARMONi-7 study, an international multicenter Phase III clinical trial evaluating ivonescimab monotherapy as first-line treatment for PD-L1 high-expressing NSCLC (versus pembrolizumab).
Several Phase III clinical trials are progressing efficiently or are being initiated in China, including:

Ivonescimab combined with chemotherapy as first-line treatment for squamous NSCLC (vs. tislelizumab combined with chemotherapy, HARMONi-6/AK112-306),
Ivonescimab combined with chemotherapy as first-line treatment for biliary tract cancer (vs. durvalumab combined with chemotherapy, HARMONi-GI1/AK112-309),
Ivonescimab combined with AK117 (CD47) as first-line treatment for PD-L1 positive head and neck squamous cell carcinoma (vs. pembrolizumab, SOLO-10/AK117-302),
First-line treatment for pancreatic cancer (HARMONi-GI2/AK112-310),
First-line treatment for triple-negative breast cancer (HARMONi-BC1/AK112-308).