GRAIL to Present at the 44th Annual J.P. Morgan Healthcare Conference

On December 15, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that company management will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, Jan. 12 at 7:30 a.m. PT.

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Live and replay webcasts may be accessed in the investor relations section of GRAIL’s website at investors.grail.com. The webcast will be archived and available for reply for at least 30 days after the event.

(Press release, Grail, DEC 15, 2025, View Source [SID1234661436])

Amira Therapeutics’ Lead Compound AMI463 Demonstrates 60% Tumor Reduction in Preclinical Oral Study

On December 15, 2025 Amira Therapeutics ("Amira"), an innovative biotechnology company focused on improving outcomes for pediatric cancer patients, reported that its lead compound, AMI463, demonstrated significant efficacy in a preclinical murine model following oral administration, achieving a 60% reduction in tumor volume compared with untreated controls.

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In addition to the in vivo results, in vitro studies have shown that AMI463 exhibits strong synergistic activity when combined with standard chemotherapy treatments in relapsed rhabdomyosarcoma (RMS), supporting its potential as a novel therapeutic option in difficult-to-treat pediatric cancers.

Soft tissue sarcomas (STS) are a rare and heterogeneous group of malignancies arising from mesenchymal tissues and are often associated with poor prognosis and limited treatment options beyond chemotherapy. Amira is advancing AMI463 primarily for rhabdomyosarcoma, the most common soft tissue sarcoma in children. RMS has an annual incidence of approximately 500 new cases in the United States and 400 pediatric cases in Europe, and it is characterized by aberrant activation of the Hedgehog signaling pathway, primarily affecting muscular tissue and hollow organs.

AMI463 is a first-in-class inhibitor that blocks the cell adhesion molecule (CAM)-related down-regulated by oncogenes (CDON). By selectively blocking CDON, AMI463 has shown strong preclinical efficacy across RMS models, including aggressive subtypes, as well as potential activity in other sarcomas and solid tumors.

The preclinical development of AMI463 has been conducted in close collaboration with the Vall d’Hebron University Hospital Research Institute Foundation (VHIR), with whom Amira has partnered since the inception of the program. This collaboration has resulted in a family of jointly owned patents protecting the use of AMI463 across multiple indications, which have been granted in Europe, the United States, and Japan.

Amira is currently preparing a scientific advice meeting with the Spanish Agency of Medicines and Medical Devices (AEMPS) to define a regulatory pathway toward first-in-human (FIH) clinical studies. The outcome of this meeting is expected to guide the required CMC, toxicology, and non-clinical development activities, enabling the company to accelerate clinical advancement of AMI463.

(Press release, Amira Therapeutics, DEC 15, 2025, View Source [SID1234661417])

Lunit Announces Collaboration with Daiichi Sankyo to Advance AI-Driven Biomarker Discovery and Translational Oncology Research

On December 15, 2025 Lunit (KRX:328130), a leading provider of AI for cancer diagnostics and precision oncology, reported a collaboration with Daiichi Sankyo (TSE: 4568) that aims to accelerate biomarker discovery and optimize translational research by integrating multiple AI-powered Lunit SCOPE digital pathology products across two oncology pipeline programs.

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Daiichi Sankyo will apply various Lunit SCOPE solutions, including SCOPE uIHC for quantitative IHC analysis and SCOPE IO for immune phenotyping and spatial analysis, to explore novel biomarkers and to potentially enrich clinical trials or to potentially support precision patient stratification for select oncology pipeline programs.

"Lunit SCOPE was built to unlock hidden insights from pathology slides – quantifying the tumor microenvironment, predicting molecular profiles and generating data-rich features to inform trial design," said Brandon Suh, CEO of Lunit. "SCOPE uIHC is now enabling the next generation of IHC-based biomarkers. By working with Daiichi Sankyo, we are embedding these capabilities into translational and clinical research, enabling faster biomarker discovery and more precise patient stratification. Ultimately, this means more efficient trials and better outcomes, where each patient has a greater chance of receiving the therapy that works best for them."

The work will include exploratory research projects and analyses across two oncology assets across multiple types of cancer, with the potential to inform future trial designs, biomarker strategies and clinical development plans.

(Press release, Daiichi Sankyo, DEC 15, 2025, https://www.prnewswire.com/news-releases/lunit-announces-collaboration-with-daiichi-sankyo-to-advance-ai-driven-biomarker-discovery-and-translational-oncology-research-302641994.html [SID1234661437])

Leucid Bio and Syenex Announce Strategic Collaboration for In Vivo CAR-T Cell Engineering

On December 15, 2025 Leucid Bio ("Leucid" or the "Company"), a privately-held biotechnology company developing innovative Chimeric Antigen Receptor T-cell (CAR-T) therapies using its proprietary lateral CAR platform, and Syenex, an open-science genetic medicines platform company, reported a strategic collaboration to access Syenex’s VivoCell Platform for the precise in vivo delivery of Leucid’s CAR-T assets including LEU011 for the treatment of solid tumours.

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In vivo CAR-T cell engineering, which generates CAR-T cells directly within the body, addresses many limitations of conventional CAR-T cell therapies. Enabling in vivo delivery removes the need for extensive and complex ex vivo cell processing and logistics, enhancing overall clinical outcomes.

The collaboration is focused on harnessing Syenex’s VivoCell Platform to precisely deliver the LEU011 construct to T-cells in vivo when systemically administered. This represents a next-generation approach, fundamentally transforming the therapeutic profile of Leucid’s lateral CAR platform, moving toward a simpler, potentially off-the-shelf administration route. By addressing the logistical hurdles of ex vivo cell administration – this collaboration is poised to unlock the full potential of the lateral CAR-T platform, including LEU011.

Under the non-exclusive agreement, Syenex will provide Leucid access to its VivoCell Platform and support the development of precision in vivo delivery vehicles tailored to Leucid’s lateral CAR-T candidates. The aim of the collaboration is to accelerate the timeline of Leucid’s in vivo programme, advancing from in vitro proof-of-concept to IND-enabling studies, while enabling Leucid to continue to clinically validate LEU011 in the ongoing Phase I/IIa AERIAL trial in patients with relapsed/refractory solid tumours.

Filippo Petti, Chief Executive Officer of Leucid Bio, said: "LEU011 has been well tolerated and demonstrated functional activity in our ongoing AERIAL trial for relapsed/refractory solid tumours. Gaining access to Syenex’s innovative VivoCell Platform will enable precise in vivo delivery of our CAR-T assets and will be key to maximising the therapeutic impact and accelerate our reach. This partnership with Syenex is key to advancing this powerful therapeutic into a more scalable, patient-friendly format, bringing us closer to addressing one of the greatest challenges in oncology."

Jay Rosanelli, Co-Founder and Chief Executive Officer of Syenex, commented, "We are thrilled to partner with Leucid Bio to apply our precision delivery technology to their cutting-edge cell therapy. This collaboration advances our mission to Cure More and validates the power of our platform to enable the development of complex, next-generation CAR-T therapies, establishing the pathway toward an off-the-shelf product in a much more scalable and efficient in vivo format. By combining Leucid Bio’s pan-cancer CAR-T with our targeted delivery system, we aim to significantly improve treatment options for patients battling solid tumours."

(Press release, Leucid Bio, DEC 15, 2025, View Source [SID1234661438])

Champions Oncology Reports Record Quarterly Service Revenue of $14.9 Million

On December 15, 2025 Champions Oncology, Inc. (Nasdaq: CSBR), a leading translational oncology research organization, reported its financial results for its second quarter of fiscal 2026, ended October 31, 2025.

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Second Quarter and Recent Highlights:

•Total revenue increased 11% to $15 million
•Oncology services profit of $7.8 million; oncology services margin of 52%
•Net income of $237,000
•Adjusted EBITDA of $843,000

First Half 2026 Highlights:

•Total revenue increased 5% to $29 million
•Oncology services profit of $13.8 million; oncology services margin of 47%
•Adjusted EBITDA of $962,000

Robert Brainin, CEO of Champions, commented, "Our recent results reinforced our confidence in the Company’s ongoing return to growth, as we continued to make progress. While our business can vary period to period, we manage and evaluate performance primarily on an annual basis and remain focused on delivering sustainable year-over-year revenue growth. We continue to be cautiously optimistic that the pharma and biotech funding environment is beginning to strengthen, which should support improved bookings as we move into calendar 2026."

"In parallel with our core services business, we continued to invest in our data platform—expanding its capabilities to provide greater value to our pharma partners—and strengthened our business development organization to support adoption of these offerings. As our data business scales, we expect it to contribute meaningfully to long-term growth, even as it introduces additional variability in shorter reporting periods. Together, these growth engines position Champions to create meaningful long-term value for our shareholders."

David Miller, CFO of Champions, added, "From a financial standpoint, the period reflected continued progress in our operating model. Oncology services margin improved as higher revenue was generated on a largely stable cost base, highlighting the leverage in our business as volumes increase. Operating expenses rose as planned, reflecting targeted investments in areas that support future growth, particularly within our data platform and related infrastructure."

"Based on our year-to-date performance and current visibility, we remain on track to deliver year-over-year revenue growth and to achieve positive adjusted EBITDA for the full fiscal year. We believe the combination of disciplined cost control and targeted strategic investment positions the Company for continued improvement as market conditions strengthen."

Second Fiscal Quarter Financial Results

Total oncology revenue for the second quarter of fiscal 2026 was $15.0 million compared to $13.5 million for the same period last year, an increase of 11.5%. An improvement in bookings quality contributed to a higher revenue conversion percentage, resulting in revenue growth for the three months ended October 31, 2025. Total costs and operating expenses for the second quarter of fiscal 2026 were $14.9 million compared to $12.8 million for the second quarter of fiscal 2025, an increase of $2.1 million or 16.4%.

For the second quarter of fiscal 2026, Champions reported net income of $237,000, including $249,000 in stock-based compensation and $357,000 in depreciation and amortization expenses. This compares to net income of $728,000 in the second quarter of fiscal 2025, which included $9,000 in stock-based compensation and $399,000 in depreciation and amortization expenses. Adjusted EBITDA, which is defined as net income excluding stock-based compensation and depreciation and amortization expenses, was $843,000 for the second quarter of fiscal 2026 compared to adjusted EBITDA of $1.1 million in the second quarter of fiscal 2025.

Cost of oncology revenue was $7.3 million, for the three months ended October 31, 2025, a decline of $166,000, or 2.2%, compared to $7.4 million in the same quarter of fiscal 2025. The decrease was primarily driven by lower outsourced lab service costs. Oncology services margin for the quarter was 52% compared to 45% for the three months ended October 31, 2024. The improvement in margin resulted from higher revenue combined with a lower cost base due to operational efficiencies implemented during the year. Oncology services margin and profit are defined below in our Non-GAAP financial information discussion.

Research and development expense for the three-months ended October 31, 2025 was $2.6 million, an increase of $927,000 or 54.9%, compared to $1.7 million for the three-months ended October 31, 2024. The increase reflected greater investment in sequencing and related activities to advance the Company’s data licensing platform. Sales and marketing expense for the quarter was $2.0 million, an increase of $247,000, or 14.1%, compared to $1.8 million in the prior year period, driven primarily by higher compensation expense to support the growth of the data business. General and administrative expense for the three-months ended October 31, 2025 was $3.0 million, an increase of $1.1 million, or 57.4%, compared to $1.9 million for the three-months ended October 31, 2024. The increase was primarily due to higher compensation expense, including stock-based compensation, and increased IT-related costs.

Net cash used in operating activities was approximately $1.9 million for the three months ended October 31, 2025, primarily driven by an increase in accounts receivable and a decline in deferred revenue. Net cash provided by financing and investing activities totaled approximately $115,000, reflecting proceeds from option exercises offset by purchases of lab and computer equipment and repayment of financing leases.

The Company ended the quarter with cash on hand of approximately $8.5 million and no debt.

Year-to-date Financial Results

Total revenue for the first half of fiscal 2026 was $29.0 million, compared to $27.6 million for the same period last year, an increase of 5.4% Total costs and operating expenses for the first half of fiscal 2026 were $29.4 million, compared to $25.5 million for the first half of fiscal 2025, an increase of $3.9 million, or 15.2%.

For the first half of fiscal 2026, Champions reported a net loss of $230,000, including $457,000 in stock-based compensation, $715,000 in depreciation and amortization expenses, and a loss on the disposal of equipment of $20,000. This compares to net income of $2.1 million in the first half of fiscal 2025, which included $267,000 in stock-based compensation and $848,000 in depreciation and amortization expenses. Excluding stock-based compensation, depreciation and amortization, and an equipment disposal loss, adjusted EBITDA was $962,000 for the first half of fiscal 2026, compared to $3.2 million in the first half of fiscal 2025.

Cost of oncology services was $15.3 million for the six months ended October 31, 2025, an increase of $757,000, or 5.2%, compared to $14.5 million for the same period in 2024. The increase resulted primarily from higher mice costs and outsourced lab services, including radiolabeling work. Importantly, as this radiolabeling work transitions into our own labs over the coming quarters, the Company anticipates a reduction in cost of sales and an improvement in oncology services margin. Oncology services margin for both the current and prior-year periods was 47%.

Research and development expense for the six months ended October 31, 2025 was $4.7 million, an increase of $1.6 million, or 49.5%, compared to $3.1 million for the same period in 2024. The increase was primarily driven by greater investment in sequencing and related costs to support the development of our data platform. Sales and marketing expense for the first half of fiscal 2026 was $3.9 million, an increase of $423,000, or 12.3%, compared to the prior-year period. General and administrative expense was $5.5 million, an increase of $1.1 million, or 25.5%, compared to $4.4 million for the six months ended October 31, 2024. The increase was primarily due to higher compensation expense and increased IT-related costs.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its second quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 691139, or provide the verbal reference "Champions Oncology".

(Press release, Champions Oncology, DEC 15, 2025, View Source [SID1234661419])