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])

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 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])

On December 15, 2025 AB Science SA (Euronext – FR0010557264 – AB) reported the publication of a new article on the preprint platform bioRxiv. This article is entitled ‘Identification of AB8939, a novel synthetic microtubule destabilizer and ALDH inhibitor that overcomes multidrug resistance in tumor cells as a drug candidate for the treatment of refractory acute myeloid leukemia’ and is freely accessible online from the bioRxiv website [1].

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Professor Olivier Hermine, President of AB Science’s Scientific Committee, member of the French Academy of Sciences and Head of the Hematology Department at Necker Hospital, commented: "Our preclinical research has identified AB8939 as a powerful compound with a novel dual mechanism of action, which holds potential for treating high-risk acute myeloid leukemia. The data indicate that AB8939 disrupts microtubule formation, a classic anti-cancer strategy, and inhibits ALDH enzymes, which are implicated in therapy resistance and the survival of leukemic stem cells. We demonstrated that AB8939 overcomes formidable drug resistance pathways, such as P-gp efflux, and is highly effective against patient-derived AML cells that are resistant to standard therapies. Most importantly, our work in advanced preclinical models shows that it can eradicate the leukemic stem cells that fuel this disease, a critical step toward preventing relapse. These robust findings provide a strong scientific rationale for the ongoing clinical trials and represent a tangible step toward developing a new, effective therapy for patients with high-risk and refractory AML."

The key findings are as follows.

AB8939 has a novel dual-targeting mechanism of action
Microtubule Destabilizer: It acts as a microtubule-targeting agent (MTA) by binding to the colchicine-binding site on β-tubulin. This interaction disrupts the microtubule network, leading to cell cycle arrest in the G2/M phase and subsequent apoptosis (programmed cell death).
ALDH Inhibitor: Through reverse proteomics, aldehyde dehydrogenases (ALDH), specifically ALDH1 and ALDH2, were identified as secondary targets of AB8939. AB8939 is a potent inhibitor of these enzymes, which are often overexpressed in tumors and are associated with cancer stem cells, tumor progression, and resistance to therapy.
AB8939 has potent and broad antiproliferative activity
AB8939 demonstrated strong and broad-spectrum antiproliferative activity against a wide variety of human cancer cell lines, with particularly high potency against hematopoietic cancers, with IC₅₀ values in the nanomolar range.
AB8939 can overcome several major mechanisms of drug resistance in cancer cells
P-glycoprotein (P-gp) Efflux: Unlike many conventional chemotherapeutics (e.g., doxorubicin and vincristine), AB8939 is not a substrate for the P-gp efflux pump. This allows it to remain effective in cancer cells that overexpress P-gp, a common cause of multidrug resistance (MDR).
β3-tubulin Expression: The molecule retains its efficacy in cell lines with high expression of β3-tubulin, another factor linked to resistance against microtubule-targeting agents.
Chemoresistance in AML: It shows high cytotoxicity against AML patient blasts, including those resistant to standard-of-care agents such as cytarabine (Ara-C) and vincristine.
In vivo evidence supporting the therapeutic potential of AB8939 in AML
In an Ara-C-resistant AML mouse model (MOLM-14), AB8939 treatment significantly inhibited tumor growth and increased survival rates.
In a patient-derived xenograft (PDX) model of high-risk AML (TG-LAM-75 with MECOM rearrangement), AB8939 monotherapy was effective, and its combination with azacitidine led to near-complete disease clearance with a manageable safety profile.
AB8939 effectively eradicated leukemic stem cells (LSCs) in an AML PDX model (TG-AML-36), suggesting that it could reduce the risk of disease relapse.

Clinical study AB18001

AB8939 is currently being evaluated in a Phase I/II clinical trial (AB18001, NCT05211570) in patients with refractory and relapsed AML. AB Science recently received regulatory approval to initiate the third stage of this study, which combines the molecule AB8939 with venetoclax for the treatment of acute myeloid leukemia [2].

The objective of the Phase 1 study was to determine the maximum tolerated dose (MTD) for different treatment cycles of AB8939.

Stage 1: Determination of the MTD after three consecutive days of treatment with AB8939 alone.
Stage 2: Determination of the MTD after 14 consecutive days of treatment with AB8939 alone.
Step 3: Determination of the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax.
Stage 4: Determination of MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax and azacitidine.
The first two stages of Phase 1 were completed with 28 and 13 patients enrolled, respectively, and the MTD of AB8939 was determined after 3 consecutive days of treatment (21.3 mg/m2 ) and after 14 consecutive days of treatment (21.3 mg/m2). The third stage now consists of evaluating the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax, a standard treatment for AML.

Intellectual property protection until 2036 or even 2044 and orphan drug protection

AB8939 was discovered by AB Science, which retains full ownership of the intellectual property rights, reflecting AB Science’s priority to develop innovative drugs aimed at improving patients’ lives.

The composition of AB8939, including its use in the treatment of AML, is covered until 2026 by a patent granted in all geographical areas where AB8939 could be marketed, including Europe (patent EP 3253749), the United States (US 10,570,122), Canada (CA 2975644), China (CN 107531685), South Korea (KR 10-2544132), Japan (JP 6713000), Hong Kong (HK 1243700), Israel (IL 253779), Australia (AU 2016214283), Russia (RU 2758259), Brazil (BR 112017016883-9), Mexico (MX 377742), India (IN 480996), and South Africa (ZA 2017/05537).

A second patent application for medical use was filed to protect the use of AB8939 in the treatment of AML with specific chromosomal abnormalities. If this application is accepted, the protection for AB8939 will be extended until 2044 for these subpopulations of AML patients.

In addition to patent protection, AB8939 is eligible for regulatory data protection in numerous countries, preventing generic competition for up to 8 years from product registration.

AB8939 has also received orphan drug designation for AML by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This orphan drug designation confers 10 and 7 years of marketing exclusivity in Europe and the US, respectively, from the date of the product registration.

(Press release, AB Science, DEC 15, 2025, View Source [SID1234661416])

On December 14, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported the company will host a conference call and webcast on Monday, December 15, 2025 at 8:30 am ET to disclose the topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat, an investigational, oral, once-daily gamma secretase inhibitor, in patients with progressing desmoid tumors.

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Webcast, Presentation Slides and Conference Call Information

Immunome will host a webcast and conference call on Monday, December 15, 2025, at 8:30 a.m. ET / 5:30 a.m. PT to discuss the Phase 3 RINGSIDE trial topline results. A live webcast, which will include presentation slides, can be accessed using this link or by visiting the Events and Presentations section of the Immunome website at View Source The conference call can be accessed by clicking on the call link and completing the online registration form, which will enable the selection of a dial-in number or callback from the system. A live question-and-answer session will follow the prepared remarks. Participants wishing to ask a question must do so via the conference call; the webcast will be listen-only. After the live webcast, the event will remain archived on the Immunome website for 90 days.

(Press release, Immunome, DEC 14, 2025, View Source [SID1234661414])