On September 26, 2024 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells, reported the pricing of an underwritten public offering of (i) 11,564,401 shares of its common stock and accompanying common stock warrants to purchase an aggregate of 2,891,100 shares of common stock and, (ii) to certain investors in lieu of common stock, pre-funded warrants to purchase 12,435,599 shares of common stock and accompanying common stock warrants to purchase an aggregate of 3,108,900 shares of common stock (Press release, Cue Biopharma, SEP 26, 2024, View Source [SID1234646883]). Each share of common stock and accompanying common stock warrant are being sold together at a combined public offering price of $0.50, and each pre-funded warrant and accompanying common stock warrant are being sold together at a combined public offering price of $0.499. The aggregate gross proceeds of the offering are expected to be approximately $12.0 million, before deducting underwriting discounts and commissions and other offering expenses. Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately and will be exercisable until all of the pre-funded warrants are exercised in full. Each common stock warrant will have an exercise price of $0.50 per share, will be exercisable immediately and will expire five years from the date of issuance. The offering is expected to close on or about September 30, 2024, subject to satisfaction of customary closing conditions. All of the securities are being offered by Cue Biopharma.

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Oppenheimer & Co. Inc. is acting as sole book-running manager for the offering. Newbridge Securities Corporation is acting as co-manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-271786) relating to the securities to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") on May 9, 2023 and declared effective on May 26, 2023. The offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and final prospectus supplement relating to the offering may also be obtained by contacting: Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at [email protected].

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

On September 26, 2024 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in the following upcoming October 2024 investor conferences (Press release, Fortress Biotech, SEP 26, 2024, View Source [SID1234646885]):

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Lytham Partners Fall 2024 Investor Conference
Date and Time: Tuesday, October 1, 2024 at 4:15 p.m. ET
Location: Virtual
Format: Fireside Chat and 1×1 Meetings
Registration link for the event: View Source

3rd Annual ROTH Healthcare Opportunities Conference
Date: Wednesday, October 9, 2024
Location: New York
Format: 1×1 Meetings

A replay of the fireside chat at the Lytham Partners Fall 2024 Investor Conference will be available shortly after the conference on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the meeting.

On September 26, 2024 RefleXion Medical, an external-beam theranostic oncology company, reported it will showcase Multi-target Treatment (MTT), the groundbreaking upgrade for its RefleXion X1 platform (Press release, RefleXion, SEP 26, 2024, View Source [SID1234646886]). This innovation allows physicians to combine SCINTIX biology-guided radiotherapy with conventional stereotactic body radiotherapy (SBRT) in a single plan to treat patients with metastatic disease. The company will also highlight learnings from its early patient treatments.

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RefleXion will showcase MTT at the American Society for Radiation Oncology (ASTRO) Annual Meeting, Sept. 29 – Oct. 3, in Washington D.C. (booth #1313), where researchers will present new scientific evidence in 22 presentations, including four oral presentations, showcasing the X1 machine with SCINTIX therapy.

"The results from our first-year patient treatments are highly encouraging," said Sean Shirvani, M.D., M.P.H., chief medical officer at RefleXion. "We are consistently observing that SCINTIX therapy detects and adapts to tumor motion in an autonomous fashion. In the lung, this means that less normal lung tissue is damaged by the ablative zone of radiotherapy. And in the bone, our system provides insurance against unanticipated shifts by the patient when the radiotherapy beam is on.

"Moreover, our clinical partners recognize the immense value of having positron emission tomography or PET data underpinning both treatment planning and delivery. This information has, in several cases, influenced the course of patient therapy," continued Shirvani.

The RefleXion X1 with SCINTIX therapy uses information from an injected PET radiopharmaceutical produced by the cancer itself in real time to determine where to deliver radiation. Because PET data is used to direct treatment, it is also an integral part of the treatment planning process.

In early SCINTIX therapy cases, PET data during treatment planning or delivery demonstrated tumor progression, uncovered additional tumors, or confirmed significant tumor movement in bone tumors, which are generally considered relatively immobile. In the bone tumor cases, SCINTIX technology accurately followed the live PET signal and delivered the dose as planned, a feat not achievable with conventional image-guided radiotherapy.

The following oral presentations highlight some of the new research being presented at ASTRO 2024. Detailed information on all 22 presentations may be found here.

Sunday, Sept. 29, 3:37 pm, room 147 – Scientific Development and Clinical Deployment of BgRT
Monday, Sept. 30, 3:00 pm, room 145 – Early Clinical Insights into FDG-Guided Radiotherapy Planning and Delivery on a Novel PET-Linac Platform in Patients with Lung and Bone Lesions: Pioneering Real-Time Biology-guided Radiotherapy
Monday, Sept. 30, 3:50 pm, room 145 – Feasibility of Biology-guided Radiotherapy with Gallium-68 PSMA-11 Radiotracer for Bony Metastases in Prostate Cancer Patients
Tuesday, Oct. 1, 8:40 am, room 152 – Impact of Synthetic PET Evaluation Prior to PET-Guided Functional Modeling in Optimizing Patient Selection for Biology-guided Radiotherapy
RefleXion’s booth will feature a multi-target SCINTIX technology interactive demonstration and SCINTIX treatment planning demonstrations.

On September 26, 2024 OSE Immunotherapeutics reported its consolidated half-year financial results and provided updates on key milestones achieved during the H1 2024 as well as the Company’s outlook for its immunotherapies in immuno-oncology and immuno-inflammation (Press release, OSE Immunotherapeutics, SEP 26, 2024, View Source [SID1234646993]).

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Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "The major milestones achieved during H1 2024 are paving the way for a transformative year for OSE. During this period, thanks to the OSE teams, the Company made significant outstanding progress.

The half-year has seen continued execution of our partnership-focused business model through three strategic pharmaceutical agreements with major partners, AbbVie and Boehringer Ingelheim, related to our differentiated immunological pipeline. These key achievements trigger a solid financial position supporting the Company’s growth, relying on our promising clinical and preclinical proprietary programs in immuno-inflammation and immuno-oncology conducted and supported by highly skilled OSE teams

We also achieved two significant inflection points on our late-stage proprietary clinical assets. In immunoinflammation, the positive clinical efficacy and safety results for Lusvertikimab in ulcerative colitis represent a strong catalyst for potential future partnership opportunities. We have generated exciting data that we plan to communicate with our investigators at an upcoming global medical conference. In immuno-oncology, the international registration study Artemia for cancer vaccine Tedopi in second-line non-small cell lung cancer treatment is now on track globally. In parallel, in order to ensure continuous portfolio development, we continue accelerating and strengthening first-in-class preclinical programs from our innovative research platforms".

Anne-Laure Autret-Cornet, Chief Financial Officer of OSE Immunotherapeutics, said: "With more than €90 million non-dilutive cash-in in 2024, our financial visibility is strongly reinforced until 2027. This allows us to prioritize funding of our recently globally launched Artemia Phase 3 registration study for our cancer vaccine Tedopi in lung cancer and to further invest in our other proprietary clinical products and innovative R&D engine to increase the value and interest of our assets."

On September 26, 2024 858 Therapeutics reported that it has raised $50 million in a Series B financing led by Avidity Partners with participation from Insight Partners, Mirae Asset Capital, and Alexandria Venture Investments, as well as existing investors Versant Ventures, NEA, and Logos Capital (Press release, 858 Therapeutics, SEP 26, 2024, View Source [SID1234646887]). As part of the financing, Monal Mehta, Ph.D., Managing Director at Avidity Partners, will join the company’s Board of Directors.

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"We are pleased to have strong backing from an elite group of life science investors," said Jeffrey Stafford, Ph.D., CEO of 858 Therapeutics. "The Series B financing is a testament to the 858 team and the progress we’ve made across our portfolio, including the advancement of our PARG inhibitor ETX-19477 into the clinic."

858 Therapeutics plans to use the proceeds to advance its pipeline of small molecule therapeutics. The company’s lead asset, ETX-19477, is a potent and selective inhibitor of the DNA repair protein PARG and is currently being evaluated in patients with advanced solid tumors. Data from the ongoing clinical trial will provide insights for advancing ETX-19477 through clinical development and for understanding the patients who may benefit most from PARG inhibition.

The Phase 1 trial for ETX-19477 is a multi-center, open-label, dose escalation and expansion study designed to evaluate safety, tolerability, dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy. The dose escalation portion of the study is preferentially enrolling patients with specific tumor types and genetic alterations that are likely to confer sensitivity to PARG inhibition. Once a recommended dose for expansion is identified, the company will initiate tumor- and biomarker-focused Phase 2 cohorts. For more information, visit www.clinicaltrials.gov (NCT06395519).

"858 Therapeutics has a seasoned management team with a track record of drugging challenging targets," said Dr. Mehta. "We are excited to partner with the company to help address unmet needs across a variety of disease types in an effort to bring transformative medicines to patients."

About ETX-19477

The company’s lead asset, ETX-19477, is a novel and potent small molecule inhibitor of PARG, a glycohydrolase that plays a pivotal role in the regulation of DNA repair mechanisms. Pharmacological inhibition of PARG results in hyperPARylation, which leads to the death of cancer cells undergoing replication stress. In multiple animal models, ETX-19477 shows potent tumor growth inhibition, which is associated with specific genetic biomarkers. 858 Therapeutics is evaluating ETX-19477 in a Phase 1 study in patients with advanced solid tumors at multiple sites in the U.S. For more information on the Phase 1 study, please visit: View Source