On March 12, 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 full year 2024 financial results and provided a corporate update (Press release, Alpha Tau Medical, MAR 12, 2025, View Source [SID1234651093]).

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"Alpha Tau has been incredibly busy and very successful throughout 2024. With fantastic clinical results observed across a number of difficult cancers, we are now able to demonstrate the broader Alpha Tau vision of expanding our focus on treating internal organ tumors of high unmet need, as well as helping metastatic patients by harnessing the potential systemic immune benefits of Alpha DaRT", said Alpha Tau Chief Executive Officer Uzi Sofer. "FDA approval of our forthcoming U.S. trials in patients with newly diagnosed pancreatic cancer and our investigator-initiated trial in immunocompromised patients with recurrent cSCC, not only aligns with our broader vision but also reflects continued progress in our regulatory pathway to approval for Alpha DaRT. In parallel, we remain focused on expanding our operational capabilities, with our Hudson, NH facility expected to complete its first phase of construction in the coming months and come online for production of Alpha DaRT later in 2025."

Recent Corporate Highlights:

● In January, Alpha Tau hosted a virtual R&D Update Day to present interim results from multiple trials as well as more information regarding the expected regulatory path forward in internal organs. Principal investigators presented data showing high disease control rate and strong interim safety results observed across three trials exploring the use of Alpha DaRT in pancreatic cancer patients. Principal investigators also reported strong interim results in median survival of patients treated with Alpha DaRT after prior therapy as compared to previously published studies of alternative monotherapies, across all analyzed subgroups.

● At the R&D Update Day, positive interim results were also reported for the first eight patients recruited in a combination trial of Alpha DaRT with pembrolizumab (Keytruda), a checkpoint inhibitor, in treating patients with recurrent unresectable or metastatic head and neck squamous cell carcinoma (HNSCC). A reported systemic objective response rate of 75% and complete response rate of 37.5% were observed, compared to historical benchmarks of 19% and 5%, respectively, for pembrolizumab on its own in the KEYNOTE-048 trial.

● Approvals for two forthcoming clinical trials exploring the use of Alpha DaRT in treating pancreatic cancer were also announced during the R&D Update Day:

o Investigational Device Exemption (IDE) received from the FDA to conduct a U.S. pilot study of Alpha DaRT together with first-line chemotherapy in patients with newly diagnosed pancreatic cancer, the first step toward regulatory approval in the U.S. The trial was initially approved for 12 patients with metastatic cancer, but was then expanded to 30 patients in two cohorts of 15 patients each, one cohort of patients with newly diagnosed locally advanced cancer and the other of patients with newly diagnosed metastatic cancer.

o Approval from France’s Ministry of Health to commence a French multicenter clinical trial of Alpha DaRT alongside capecitabine for patients with locally advanced pancreatic cancer, as well as a second study at a single center in France examining the use of Alpha DaRT delivered via Fine Needle System, or FNS, in the treatment of locally advanced pancreatic cancer.

● In January, researchers from Hadassah Medical Center presented a poster entitled "Interim analysis of feasibility, safety, and tumor control in two first-in-human trials of a novel alpha-emitting radionuclide for pancreatic adenocarcinoma" at the prestigious 2025 ASCO (Free ASCO Whitepaper) GI Symposium, with interim data demonstrating 100% disease control rate and a strong safety profile. They also reported on a patient with pancreatic adenocarcinoma with metastases in the liver, who was seeing inadequate response from second-line chemotherapy but then saw full resolution of all tumors on PET scan after adding in Alpha DaRT treatment.

● In December, Alpha Tau announced the appointment of Maya Netser to its Board of Directors, bringing a wealth of experience and a keen understanding of the industry from her many years of corporate leadership and advisory, following the completion of Meir Jakobsohn’s term as a director.

Upcoming Milestones:

● Targeting first patient treated in Israel for brain cancer in H1 2025.

● Anticipating response from Japan’s PMDA in Q3 2025 to application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.

● Targeting first patient enrolled in pancreatic cancer pilot study in the U.S. in Q2 2025.

● Seeking FDA IDE approval in Q2 2025 to conduct early feasibility study in recurrent glioblastoma multiforme (GBM) patients.

● Targeting completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q3 2025. For more information, please see here: View Source

Financial results for year ended December 31, 2024

R&D expenses for the year ended December 31, 2024 were $27.0 million, compared to $26.4 million for the same period in 2023, due to increased employee compensation and benefits, including share-based compensation, increased costs of raw materials, reduced government grants, and increased travel expenses related to our U.S. multi-center pivotal trial, offset by lower third-party contractor expenses.

Marketing expenses for the year ended December 31, 2024 were $2.3 million, compared to $1.9 million for the same period in 2023, due to increased marketing activities and travel abroad.

G&A expenses for the year ended December 31, 2024 were $6.7 million, compared to $7.3 million for the same period in 2023, primarily due to decreased professional fees (including D&O insurance and legal expenses), offset by increased travel expenses and increased employee compensation and benefits, including share-based compensation.

Financial income, net, for the year ended December 31, 2024 was $4.3 million, compared to $6.5 million for the same period in 2023, due to a decrease in income from revaluation of warrants and in interest from bank deposits and an increase in interest on long-term loan, offset by changes in foreign exchange rates .

For the year ended December 31, 2024, the Company had a net loss of $31.8 million, or $0.45 per share, compared to a net loss of $29.2 million, or $0.42 per share, in the year ending December 31, 2023.

Balance Sheet Highlights

As of December 31, 2024, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $62.9 million, compared to $84.9 million at December 31, 2023. The Company expects that this cash balance will be sufficient to fund anticipated operations for at least two years.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On March 12, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported it will participate at the 37th Annual Roth Conference on March 16th to 18th (Press release, Actinium Pharmaceuticals, MAR 12, 2025, View Source [SID1234651092]).

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Actinium management will be in attendance during the conference and will be available for 1-on-1 meetings on March 17th and 18th. Interested investors should contact their ROTH representative or submit a registration request at Roth2025Registration.

On March 12, 2025 Pierre Fabre Laboratories and RedRidge Bio ("RedRidge") reported an exclusive R&D collaboration and license agreement to identify and develop biparatopic antibody (BPA) drug candidates against multiple targets (Press release, Pierre Fabre, MAR 12, 2025, View Source [SID1234651082]). In line with Pierre Fabre Laboratories’ innovation strategy, the partnership’s therapeutic focus will be on precision oncology as well as dermatology and rare diseases.

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Under the terms of the agreement, RedRidge will provide its capabilities to engineer, screen and characterize BPAs against an undisclosed portfolio of jointly nominated targets, while Pierre Fabre Laboratories will provide their drug development expertise to help drive two co-development programs through clinical development. RedRidge will hold exclusive commercial rights in the United States, Canada, and Japan for both programs, while Pierre Fabre Laboratories will hold exclusive rest-of-world rights. In addition, Pierre Fabre Laboratories will hold exclusive worldwide rights for a third program after a hand-off by RedRidge at a preclinical stage.

Financial terms of the agreement are not disclosed but include investment participation by Pierre Fabre Laboratories in RedRidge’s Series A financing that will be announced separately, as well as upfront, milestone and future sales royalty payments in addition to funded research payments for Pierre Fabre Laboratories’ worldwide program. RedRidge and Pierre Fabre Laboratories will share R&D costs for the co-development programs.

"This strategic alliance attests to the RedRidge team’s expertise in innovation and drug discovery for a wide variety of therapeutic targets. We are thrilled to join forces with Pierre Fabre Laboratories as a highly experienced development partner and look forward to building a long-term partnership that synergistically leverages the capabilities of each company," said Alex Mayweg, PhD, chairperson of RedRidge’s board and a managing director at Versant Ventures.

"Pierre Fabre Laboratories are excited to enter into this agreement with RedRidge, which confirms our commitment to collaborate with innovative biotechnology companies. This partnership will allow us to capitalize on RedRidge’s cutting-edge expertise in biparatopic antibody drug discovery to deliver high quality clinical candidates on multiple targets addressing oncology, dermatology and rare diseases. It represents a significant milestone in the implementation of our strategy to enrich further our R&D pipeline," stated Francesco Hofmann, PhD, Head of Research and Development for Medical Care at Pierre Fabre Laboratories."

On March 11, 2025 Cue Biopharma reported the Ninth Amendment to the Collaboration, License and Option Agreement (the "Ninth Amendment") is entered into as of the last signature set forth below (the "Ninth Amendment Effective Date"), by and between Cue Biopharma, Inc., a Delaware corporation, having an address of 40 Guest Street, Boston, MA 02135 ("Cue"), and LG Chem Ltd., with its principal place of business at LG Twin Towers, 128, Yeoui-daero, Yeongdeungpo-gu, Seoul, 07336, Republic of Korea ("LGC"). Cue and LGC may be referred to herein individually as a "Party" or collectively as the "Parties".

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Whereas, the Parties entered into a Collaboration, License and Option Agreement as of November 6, 2018 (the "Original Agreement") that was subsequently amended on March 15, 2019, August 5, 2019, October 29, 2019, December 18, 2019, January 10, 2020, February 14, 2020, May 14, 2020 and December 7, 2020 (the "First Amendment", "Second Amendment", "Third Amendment", "Fourth Amendment", "Fifth Amendment", "Sixth Amendment", "Seventh Amendment" and "Eighth Amendment", respectively, and collectively with the Original Agreement, the "Agreement");

Whereas, under the Agreement, Cue granted to LGC, inter alia, certain licenses, sublicenses and other rights relating to the CUE-101 Program, including the right to use, Research, Develop, Manufacture, Commercialize and otherwise exploit CUE-101 Compounds, and Collaboration Products that consist of or contain a CUE-101 Compound in any dosage form or formulation or mode of administration alone or in combination with one or more other therapeutically active ingredients (such products hereinafter "CUE-101 Products") in the Field in the LGC Territory; and

Whereas, Cue desires to acquire all of LGC’s rights in the CUE-101 Program (the "LGC CUE-101 Program Rights"), and LGC desires to terminate all of its rights under the CUE-101 Program, including the CUE-101 Compounds and CUE-101 Products, pursuant to Section 13.2(a) of the Agreement in exchange for the consideration set forth herein, and the Parties are entering into this Ninth Amendment to set forth the consideration agreed to between the Parties pursuant to Section 13.3(c)(iii) of the Agreement and to clarify the terms pursuant to which all LGC CUE-101 Program Rights would revert back to Cue.

Now, Therefore, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Cue and LGC hereby agree as follows:

1.
All capitalized terms used (including in the recitals) but not separately defined in this Ninth Amendment shall have the meaning ascribed to them in the Agreement.
The Parties acknowledge and agree that the Agreement is hereby terminated by LGC for convenience under Section 13.2(a) of the Agreement as to the CUE-101 Program effective as of the Ninth Amendment Effective Date, and for purposes of the Agreement, notice of termination will be deemed to have occurred on the Ninth Amendment Effective Date notwithstanding any notice period requirement. From and after the Ninth Amendment Effective Date, the CUE-101 Compounds and CUE-101 Products will become Terminated Products. Without limiting the generality of the foregoing, it is understood and agreed that (i) HPV16 shall no longer be deemed a Collaboration Antigen, (ii) Collaboration Compounds shall no longer include CUE-101 Compounds, and (iii) Collaboration Products shall no longer include CUE-101 Products; in each case, except that, for purposes of licenses to Cue under Sections 2.4(a), 2.4(b) and 2.4(c) of the Agreement that survive termination pursuant to Section 13.3(c) of the Agreement, the references to Collaboration Compounds and Collaboration Products in such sections will be deemed to include the Terminated Products that were formerly the CUE-101 Compounds and CUE-101 Products. Cue acknowledges and agrees that, as of the Effective Date, LGC has fully complied with all of LGC’s obligations under the Agreement to pay any payment or reimburse any amount to Cue related to the CUE-101 Program prior to the Ninth Amendment Effective Date, and no such obligation remains outstanding as of the Ninth Amendment Effective Date.

2.
For purposes of termination of the CUE-101 Program only, the Parties agree that Section 13.6 of the Agreement is hereby deleted in its entirety and replaced with the following:
"Except as set forth in the Ninth Amendment, neither Party will have any rights or obligations under the Agreement with respect to the CUE-101 Program after the Ninth Amendment Effective Date except:

(a) termination of this Agreement with respect to the CUE-101 Program shall not relieve the Parties of any obligation or right accrued under the CUE-101 Program prior to the Ninth Amendment Effective Date; and

(b) the obligations and rights of the Parties under the following provisions of this Agreement to the extent applicable to the CUE-101 Program shall survive termination of this Agreement with respect to the CUE-101 Program: Article VII (solely to the extent obligations accrued prior to the date of termination), Article VIII, Article XI (excluding Section 11.4), Article XII, Article XIV, and Article XV (except that Section 15.6(a) will not be deemed to prohibit transfer of Cue’s rights under the licenses with respect to the Terminated Products under Section 13.3(c)(iii)), the last sentence of Section 4.15, and Sections 9.1(a)-(b) and (d), 9.3(i), 9.10(a)- (d), 10.1, 13.3, 13.5, 13.6, 13.7, 13.8 and 13.9. "

3.
Pursuant to Section 13.3(c)(iii) of the Agreement and in consideration for the reversion of all LGC CUE-101 Program Rights back to Cue pursuant to this Ninth Amendment, the Parties have agreed that Cue will make payments to LGC according to one or more of the following scenarios, if and when applicable.
(i) Royalties on Net Sales of CUE-101 Products in the LGC Territory

Cue will make Calendar Quarterly the following non-refundable royalty payments to LGC according to the royalty rates set forth below based on Net Sales in the LGC Territory for the Royalty Term, with the royalties calculated according to (i) the Net Sales definition in Section 1.245 of the Agreement (with CUE-101 Product substituted for Collaboration Products and "Sublicensees" defined as any Third Party to which Cue has granted a license of its rights with respect to the CUE-101 Product (including a sublicense of its rights under Section 13.3(c)(iii) of the Agreement), and otherwise mutatis mutandis), and (ii) the provisions for Royalty Term, Royalty Step Down, Royalty Offsets and Royalty Floor as set forth in Sections 7.6(b)-(e) of the Agreement (with CUE-101 Products substituted for Collaboration Products).

(Filing, Cue Biopharma, MAR 11, 2025, View Source [SID1234663871])

On March 11, 2025 GenScript reported its annual results for the year 2024 (Presentation, GenScript, MAR 11, 2025, https://www.genscript.com/gsfiles/IPO/2024_GenScript_Annual_Results_EN.pdf?=2?1720353431 [SID1234652211]).

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