On December 19, 2025 IN8bio, Inc. ("IN8Bio" or the "Company") (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative γδ T cell therapies for cancer and autoimmune diseases, reported that it has entered into a definitive securities purchase agreement ("SPA") with certain institutional and accredited investors for up to approximately $40.2 million in gross proceeds through a private placement, priced at-the-market under Nasdaq rules. The net proceeds from the initial tranche of the financing are expected to fund the Company’s current operating plans into the first half of 2027.

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The private placement includes new and existing investors including Coastlands Capital, Stonepine Capital Management and 683 Capital Partners, LP along with directors and officers of the Company.

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

Under the terms of the SPA, the private placement includes an initial closing of approximately $20.1 million in gross proceeds. At the initial closing, the Company will sell 5,127,029 shares of common stock at a purchase price of $1.38 per share and, in lieu of common stock, pre-funded warrants to purchase up to 9,452,677 shares of common stock, at a purchase price $1.3799 for each pre-funded warrant. The pre-funded warrants will have an exercise price of $0.0001 per share and will be immediately exercisable. The Company will be eligible to receive up to an additional approximately $20.1 million in gross proceeds in exchange for up to 14,579,706 shares of common stock (or, for certain investors, pre-funded warrants in lieu of common stock), subject to achieving certain milestone-driven conditions related to preclinical data for the Company’s CD-19 targeting INB-619 product candidate and share price.

IN8bio intends to use the net proceeds from the private placement to fund the IND enabling studies of INB-619, for use in oncology and autoimmune diseases. The Company expects to generate early animal model data for initial discussions with the U.S. Food and Drug Administration ("FDA") in 2026 with pivotal animal model data and potential IND submission in 2027. The Company also intends to use a portion of the net proceeds to fund the submission of data from the INB-200 and INB-400 Phase 1 and Phase 2 clinical programs in newly diagnosed glioblastoma to the FDA. Funds will be used to seek FDA feedback and guidance on any potential registrational pathway, as well as for working capital and general corporate purposes.

The initial closing of the private placement is expected to occur on or about December 22, 2025, subject to satisfaction of customary closing conditions.

The offer and sale of the foregoing securities is being made in a private placement pursuant to an exemption under the Securities Act of 1933, as amended (the "Securities Act"), and the securities have not been registered under the Securities Act or applicable state securities laws. The securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Concurrently with the execution of the securities purchase agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock and shares of common stock issuable upon the exercise of the warrants following the closing of each tranche.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities, nor shall there be any sale of the 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, In8bio, DEC 19, 2025, View Source [SID1234661558])

On December 19, 2025 Nimbus Therapeutics, LLC ("Nimbus Therapeutics" or "Nimbus"), a biotechnology company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, reported the completion of dose escalation (Part A) in its Phase 1/2 clinical trial of NDI-219216, the company’s investigational non-covalent Werner syndrome helicase (WRN) inhibitor for the treatment of microsatellite instability-high (MSI-H) tumors.

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Data thus far from the dose escalation portion of the trial demonstrated that NDI-219216 has a favorable safety profile, with no dose-limiting toxicities or severe treatment-related adverse events observed through the maximum administered dose (MAD). No maximum tolerated dose (MTD) was reached. Pharmacokinetic and pharmacodynamic data indicated that NDI-219216 achieved robust WRN target engagement for more than 24 hours at multiple dose levels. The company completed dose escalation approximately nine months ahead of schedule, with enrollment continuing to accelerate across global clinical sites.

"Completing dose escalation represents an important milestone in the clinical development of NDI-219216," said Anita Scheuber, M.D., Ph.D., Senior Vice President, Therapeutic Area Head, Oncology at Nimbus. "We are encouraged by the favorable safety profile and robust target coverage that is translating into early clinical activity in patients. The accelerated timeline, driven by strong patient recruitment, underscores the significant unmet need in this patient population. These results reinforce our confidence in NDI-219216’s differentiated profile and its potential to address patients with MSI-H tumors who have limited treatment options. We look forward to sharing clinical data at an upcoming scientific conference."

The Phase 1/2 clinical trial (NCT06898450) is an open-label study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of NDI-219216 in patients with advanced solid tumors. The study is being conducted in three parts: Part A (dose escalation), Part B (dose optimization), and Part C (dose expansion). With Part A now complete, the trial is advancing to Part B, which will determine the recommended dose(s) for further evaluation.

About NDI-219216

NDI-219216 is a highly potent and selective non-covalent investigational inhibitor of Werner syndrome helicase (WRN) activity being developed for the treatment of MSI-H tumors. WRN is a DNA helicase required for DNA replication and DNA repair and is a validated synthetic lethal target for tumors with microsatellite instability (MSI). MSI is a phenotypic consequence of deficient mismatch repair (dMMR) and occurs in various tumor types, including colorectal, gastric, and endometrial cancers. In preclinical studies, treatment with NDI-219216 exhibited robust antitumor activity across multiple cell line-derived xenograft (CDX) and patient-derived xenograft (PDX) MSI-H tumor models, including models for colorectal, gastric, and endometrial cancers.

(Press release, Nimbus Therapeutics, DEC 19, 2025, View Source [SID1234661559])

On December 19, 2025 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported financial results for fiscal year 2025.

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Financial Highlights for the Fiscal Year Ended September 30, 2025

For the fiscal year ended September 30, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $62.4 million, or $1.79 per basic and diluted share, and $1.4 million of revenue. This compares with net loss attributable to common stockholders of $75.4 million, or $4.06 per basic and diluted share, and no revenue for the prior year.

Revenue in fiscal 2025 consisted of the initial sales in June 2025 into the sales channels in Germany and the UK for LYTENAVA (bevacizumab gamma) where title to the product has transferred to the distributor. Overall, there has been a sustained increase in both the number of accounts ordering LYTENAVA and the breadth of prescribing clinicians across both markets during the early stages of fiscal year 2026. In addition to optimal market access and pricing at the national and sub-national level in both the UK and Germany, recent developments that should contribute to continued improvements in unit sales include LYTENAVA acceptance into the tender framework in the UK in December 2025 and the initiation of a multi-center non-interventional study in Germany to gather real-world data. Gross profit for fiscal 2025 was impacted negatively due to increased reserves for short-dated inventory included in the original shipments to the UK in June 2025.

Overall expenses in fiscal 2025 were $4.6 million lower than fiscal 2024 primarily due to a significant reduction in R&D expenses associated with the completion of the NORSE Eight clinical trial in fiscal 2024. The reduction in R&D expenses was partially offset by increased SG&A expenses primarily related to launching LYTENAVA in Europe in June 2025.

As of September 30, 2025, Outlook Therapeutics had cash and cash equivalents of $8.1 million, which does not include $14.9 million of net proceeds from sales under its at-the-market offering program after September 30, 2025.

"Over the course of fiscal year 2025, our team has worked diligently to position Outlook Therapeutics for success. We are preparing now for potential approval and progressing commercial launch activities in the U.S., as we await a decision from the FDA in just a few short weeks," commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics. "In Europe, our initial shipments of inventory are being used to prime and prepare to grow the market. Commercial activities remain ongoing as we push ahead with our efforts to expand into the next wave of country launches, including Austria and the Netherlands. Outside the U.S., we continue to identify potential partners for additional expansion. As we close out the remainder of 2025, our commitment remains focused on providing patients and physicians with access to an approved ophthalmic formulation of bevacizumab."

Upcoming Near Term Milestone

U.S. Food and Drug Administration (FDA) PDUFA goal date for ONS-5010 is December 31, 2025.

About ONS-5010 / LYTENAVA (bevacizumab-vikg, bevacizumab gamma)

ONS-5010/LYTENAVA is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.

In the United States, ONS-5010/LYTENAVA (bevacizumab-vikg) is investigational. In certain European Union Member States, ONS-5010/LYTENAVA must receive pricing and reimbursement approval before it can be sold.

Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

(Press release, Outlook Therapeutics, DEC 19, 2025, View Source [SID1234661561])

On December 19, 2025 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the oral presentation of interim data from the VB-C-03 trial at the 10th International Congress on Innovative Approaches in Head & Neck Oncology (ICHNO) on March 20, 2026.

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The VB-C-03 trial is investigating abi-suva in combination with KEYTRUDA (pembrolizumab) in 1st line unresectable recurrent or metastatic head and neck cancer patients (NCT06016920). Nykode is further advancing abi-suva development in 1st line head and neck cancer through the Abili-T phase 2 randomized controlled trial.

Presentation details:
Location: ICHNO 2026, Seville, Spain
Date: March 20, 2026
Time: 15:15-16:15 (CET)

The abstract is expected to be published on February 19, 2026.

Michael Engsig, Chief Executive Officer of Nykode, commented: "As previously announced, we look forward to providing further insight into the C-03 clinical data from 1st line head and neck cancer patients which supported our recently communicated strategy to further investigate abi-suva in this population with significant unmet needs."

(Press release, Nykode Therapeutics, DEC 19, 2025, View Source [SID1234661560])

On December 18, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that CEO Uzi Sofer and CFO Raphi Levy will present a corporate overview and update at the J.P. Morgan 2026 Healthcare Conference on Thursday, January 15, 2026 at 11:15am PT / 2:15pm ET, in San Francisco, CA, and will host institutional investor meetings at the event.

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Event: J.P. Morgan 2026 Healthcare Conference
Format: Presentation and 1-on-1 Meetings
Date: January 15, 2026
Time: 11:15AM PT – 11:55AM PT
Location: Westin St. Francis, San Francisco, CA

Webcast: Link will be posted on the "Events & Presentations" page in the Investor Relations section on the Company’s website at View Source

Please reach out to your J.P. Morgan representative to schedule 1-on-1 meetings with Mr. Sofer and Mr. Levy.

(Press release, Alpha Tau Medical, DEC 18, 2025, View Source [SID1234661526])