On February 20, 2025 Harbour BioMed (HKEX: 02142, the "Company"), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology, and Insilico Medicine ("Insilico"), a clinical stage generative artificial intelligence (AI)-driven biotechnology company, reported a strategic collaboration to accelerate the discovery and development of innovative therapeutic antibodies, leveraging their respective technological strengths in antibody discovery and artificial intelligence (Press release, Harbour BioMed, FEB 20, 2025, View Source [SID1234650433]).

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Under the collaboration agreement, the parties will combine Harbour BioMed’s industry-leading technology platform, proprietary dataset and extensive expertise in antibody development with Insilico’s advanced capabilities in designing integrated AI-driven drug discovery and development platforms to jointly develop the next-generation AI-powered antibody application. Additionally, the two companies will collaborate on early-stage drug discovery programs targeting novel, specific antibodies, leveraging Insilico’s AI expertise and Harbour BioMed’s wet lab capabilities. These efforts aim to deliver innovative therapeutic solutions for the unmet medical needs of immunology, oncology, and neuroscience.

Harbour BioMed has built a strong foundation in antibody discovery and development, underpinned by its advanced technology platform, proprietary dataset, and deep expertise. The Company’s proprietary Harbour Mice platform enables the generation of fully human monoclonal antibodies in both conventional (H2L2) and heavy chain-only (HCAb) formats, eliminating the need for additional engineering or humanization. The HCAb technology, in particular, produces unique, fully human heavy chain-only antibodies that are approximately half the size of conventional IgGs, offering significant advantages for next-generation antibody therapies. With a clinically validated and globally recognized platform, Harbour BioMed has applied its technology in more than 250 drug discovery programs across various therapeutic areas, establishing itself as a leader in the field of biotherapeutics.

Insilico has previously showcased the capability of its proprietary AI platform to significantly reduce cost and improve efficiency in the early stages of small molecule drug discovery and development. Since 2021, the company has established a wholly-owned pipeline of 30 assets powered by its Pharma.AI platform, 10 of which have received IND clearance, setting a benchmark for AI-driven drug discovery and development. In July 2024, Insilico introduced Generative Biologics, an AI-powered tool for de novo protein engineering, designed to accelerate the development of next-generation biologics. Moving forward, the company plans to leverage real-world case studies to further refine and advance the application through ongoing enhancements and iterative improvements.

"We are excited to collaborate with Insilico, a pioneer and leading advocate in AI-driven drug discovery and development, to integrate AI technologies with our industry-leading technology platform and proven expertise in antibody discovery and development," said Jingsong Wang, MD, PhD, Founder, Chairman, and CEO of Harbour BioMed. "By combining our validated Harbour Mice platform with advanced generative AI approaches, we aim to further streamline antibody discovery, enhance candidate selection, and ultimately bring innovative therapies to patients more efficiently."

"By combining advanced machine learning models with biological expertise, AI platforms are transforming antibody discovery and engineering – enabling the prediction of antibody structures, identification of binding sites, and design of candidates with enhanced specificity, efficacy, and safety," said Feng Ren, PhD, Co-CEO and Chief Scientific Officer of Insilico Medicine. "High-quality dataset and wet-lab validation are critical components in this process, and we are thrilled to collaborate with Harbour BioMed who excel in these areas. Together, we aim to build the next generation AI-driven antibody platforms and deliver breakthrough antibody therapies to address critical healthcare needs."

On February 20, 2025 Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) reported its financial results for the year ended 31 December 2024 (Press release, Telix Pharmaceuticals, FEB 20, 2025, View Source [SID1234650432]). All figures are in AU$ unless stated otherwise.

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FY2024 highlights

Total revenue, driven primarily from sales of Illuccix of $783.2 million, up by 56%1 from $502.5 million in 2023, beating full year guidance2.
Second year of profitable growth, delivered in a period of investment, including:
R&D investment of $194.6 million, in line with guidance, with a focus on late-stage assets.
Expanded global supply chain and product delivery infrastructure, including acquisitions of ARTMS, Inc. and IsoTherapeutics Group, LLC, and expansion of Telix Manufacturing Solutions’ Brussels South facility, resulting in an incremental increase of $15.8 million in manufacturing and distribution investment.
Adjusted EBITDA of $99.3 million, up by 70%, demonstrating strong underlying growth3.
Telix continued to deliver on its growth strategy. The Company’s key achievements, aligned to its strategic pillars:
Grow precision medicine: Prepared for launch of three new products TLX007-CDx (Gozellix), TLX101-CDx (Pixclara) and TLX250-CDx (Zircaix)4 in 2025 while continuing to increase sales and market share for Illuccix.
Deliver late-stage therapeutics: Expanded ProstACT GLOBAL Phase 3 prostate cancer therapy trial recruitment in the U.S. and continued to advance therapeutic trials for the brain and kidney cancer programs.
Build next generation pipeline: Delivered clinical proof-of-concept for first alpha therapy candidate in prostate cancer (TLX592) and added depth to urology franchise with acquisition of FAP5-targeting theranostic.
Expand global delivery infrastructure: Completed acquisitions of ARTMS, IsoTherapeutics and RLS (USA), Inc. (RLS)6 and expanded Brussels South facility, in preparation to commence GMP7 production in 2025.
For a full list of operational achievements, please refer to the Telix 2024 Annual Report.

1. All comparisons to Full Year 2023 results.

2. Previously stated guidance of AU$745 million to AU$776 million (US$490 million to US$510 million).

3. Adjusted EBITDA excludes one-off expenses related to both the Company’s U.S. capital markets activity ($9.1 million) and strategic acquisitions ($8.2 million).

4. Launch and brand names subject to regulatory approval.

5. Fibroblast activation protein. Transaction subject to customary closing conditions.

6. RLS acquisition completed 27 January 2025, subsequent to year end. Refer to ASX disclosure.

7. Good manufacturing practice.

Summary Group financial results

Full Year 2024

Full Year 2023

AU$M

AU$M

% change

Revenue

783.2

502.5

56 %

Cost of sales

(273.6)

(188.2)

45 %

Gross profit

509.6

314.3

62 %

Research and development (R&D)

(194.6)

(128.5)

51 %

Selling and marketing

(85.5)

(50.1)

71 %

Manufacturing and distribution

(25.7)

(9.9)

160 %

General and administration

(129.8)

(74.2)

75 %

Other gains/(losses) (net)

8.1

(35.9)

*

Operating profit

82.1

15.7

423 %

Profit after tax

49.9

5.2

860 %

Adjusted EBITDA1

99.3

58.4

70 %

Cash from operating activities

43.0

23.9

80 %

1. Earnings before interest, tax, depreciation and amortization.

Commentary

Group CEO, Dr. Christian Behrenbruch, commented on the result:

"2024 has been an extraordinary year for Telix. We generated strong financial growth while investing for the future. The Precision Medicine business is poised for step-change growth with three commercial product launches planned for this year in the U.S. and the European rollout of Illuccix. We have a deep therapeutic pipeline with multiple assets moving into pivotal trials, and we are building out the infrastructure to ensure we can deliver our products to patients around the world. We see 2025 as a year of significant growth and evolution for Telix in terms of international business, multiple product launches and the integration of key infrastructure that will further deliver on our mission to ensure global patient access."

Further details on the Company’s results can be found in the Appendix 4E, investor presentation, and 2024 Annual Report lodged with the ASX and also available on the Company’s website.

Guidance

Telix provides FY2025 revenue guidance of $1.18 billion to $1.23 billion (US$770 million to US$800 million1). This guidance includes revenue from Illuccix (in jurisdictions with a marketing authorization)2 and 11 months of revenue from RLS (and excluding RLS revenue generated from Illuccix). Guidance does not reflect revenue for products that have not yet received a marketing authorization (for example, Gozellix, Pixclara and Zircaix3).

Telix has also provided R&D expenditure guidance, expecting an increased investment range of 20% to 25% compared to FY2024.

lnvestor call

An investor webcast will be held at 9.00am AEDT on Friday 21 February 2025 (5.00pm EST, Thursday 20 February 2025).

Participants can register for the webcast and find audio call details at the following link: View Source diamondpass/10044775-kmnuu.html

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.

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.

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.