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])

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])

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])

On December 15, 2025 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported it will participate in the Biotech Showcase in San Francisco, CA, from January 13-15, 2026. This premier event is for private and micro-mid-cap biotechnology companies to highlight their innovation, connect with global investors, and engage with executives from prominent biopharmaceutical companies.

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Diakonos Oncology will be represented by Jay Hartenbach, President and COO, who will provide a company presentation on the latest clinical developments of DOC1021, a first-in-class, patient-derived double-loaded dendritic cell investigational therapy for aggressive cancers. Mr. Hartenbach will also join industry-leading C-suite executives on a panel to discuss how technological advancements are driving paradigm shifts in the cell and gene therapy landscape.

"Diakonos is advancing immunotherapy through our innovative double-loading dendritic cell treatments that harness the body’s immune system to target cancer with specificity and rigor," said Jay Hartenbach, President and COO of Diakonos Oncology. "I’m honored to join this discussion on the breakthroughs transforming medicine and excited to showcase Diakonos’ leadership in the field."

Details of the company presentation and panel participation are as follows:

Company Overview Presentation
Date: Monday, January 12, 2026, at 2:15 PM Pacific Standard Time
Location: Franciscan B (Ballroom Level), Hilton Union Square, 333 O’Farrell St, San Francisco, CA 94102

Panel Participation
Session Title: Engineering the Future: Advances in Cell and Gene Therapies
Description: Explore cutting-edge advances in cell and gene therapies that reshape the treatment landscape and create new investment opportunities. This session highlights emerging technologies driving transformative therapeutics.
Date: Tuesday, January 13, 2026, at 8:00-9:00 AM Pacific Standard Time
Location: Yosemite A, Hilton Union Square, 333 O’Farrell St, San Francisco, CA 94102

Diakonos’s management team will be available for one-on-one meetings during the Biotech Showcase for interested parties.

To learn more about the event, please visit https://informaconnect.com/biotech-showcase, or to schedule one-on-one meetings, please email [email protected]

About DOC1021

DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that uniquely combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double-loading approach, which mimics a viral infection, unlocks a synergistic and exponentially more powerful tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient’s immune cells for manufacturing and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 allows for simple administration in the outpatient setting and broad reach via community cancer centers.

Diakonos currently has two active clinical trials with DOC102, a Phase 1 pancreatic cancer study (NCT04157127) and a Phase 2 glioblastoma (GBM) study (NCT06805305). Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs, in October 2023 and May 2024, respectively. The company also received Orphan Drug Designation for the GBM program in January 2024. The refractory melanoma Phase 1/2 study with DOC1021 will be initiated with the facilitation and support of the Cancer Prevention and Research Institute of Texas (CPRIT).

(Press release, Diakonos Oncology, DEC 15, 2025, https://www.prnewswire.com/news-releases/diakonos-oncology-to-present-corporate-overview-and-participate-in-panel-at-2026-biotech-showcase-302641688.html [SID1234661439])

On December 15, 2025 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics" or the "Company"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported it has entered into definitive agreements for the issuance and sale of an aggregate of 5,227,275 shares of its common stock at an offering price of $0.33 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. Additionally, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to an aggregate of 5,227,275 shares of common stock at an exercise price of $0.33 per share. The unregistered warrants will be exercisable beginning on the effective date of, and subject to, approval by the Company’s stockholders of the issuance of the shares of common stock upon exercise of the unregistered warrants (the "Stockholder Approval") and will expire five years following the date of the Stockholder Approval. The closing of the offering is expected to occur on or about December 16, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $1.7 million, before deducting placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the unregistered warrants, if fully exercised on a cash basis, will be approximately $1.7 million. No assurance can be given that the Stockholder Approval will be achieved or that any of the unregistered warrants will be exercised. FibroBiologics intends to use the net proceeds from the offering for working capital and general corporate purposes.

The shares of common stock offered in the registered direct offering (but not the unregistered warrants issued in the concurrent private placement and the shares issuable upon exercise of such unregistered warrants) described above are being offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-284663) initially filed with the Securities and Exchange Commission (the "SEC") on February 3, 2025 and which became effective on February 10, 2025. The offering of the shares of common stock in the registered direct offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The unregistered warrants to be issued in the concurrent private placement and the shares issuable upon exercise of such warrants are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and/or Regulation D promulgated thereunder, have not been registered under the Act or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

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

(Press release, FibroBiologics, DEC 15, 2025, View Source [SID1234661420])