On November 19, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported third quarter 2024 financial results and provided a corporate update (Press release, Alpha Tau Medical, NOV 19, 2024, View Source [SID1234648496]).

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"Alpha Tau has continued to make great progress during 2024, with a number of important trials moving ahead and continued generation of data across superficial tumors and cancers of internal organs," said Alpha Tau Chief Executive Officer Uzi Sofer. "Our decision to use the ReSTART pivotal trial to explore our implementation of the Alpha DaRT treatment with community clinicians such as Mohs surgeons continues to bear fruit. We look forward to releasing important data in internal organ cancers in the coming months and giving our stakeholders a deeper look at the future we envision for the Alpha DaRT," stated Alpha Tau CEO Uzi Sofer.

Recent Corporate Highlights:

● In October, Alpha Tau announced its acceptance into FDA’s Total Product Life Cycle Advisory Program (TAP) to accelerate market access to Alpha DaRT for patients with recurrent glioblastoma multiforme (GBM). TAP’s primary goal is to expedite and enable patient access to innovative and highly promising medical devices which are not currently on the market by providing frequent, and strategic communications with the FDA, and by facilitating engagement with other key parties for developers of devices of public health importance, working toward reducing the time, cost and uncertainty of patient access through reimbursement and commercial adoption following FDA authorization.

● In October, the first patient with recurrent lung cancer was treated in a clinical trial at Hadassah Medical Center in Jerusalem, Israel. The study will assess safety and feasilibity of delivering Alpha DaRT sources into the lung using an endobronchial ultrasound (EBUS) procedure, including the rate of successful source placement and any treatment-related adverse events. For more information, please see here: View Source

● In September, the FDA approved and Investigational Device Exemption (IDE) application to initiate a multi-center study for the treatment of recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients using the Alpha DaRT. The clinical study, which is an investigator-initiated study led by the Winship Cancer Institute of Emory University in Atlanta, has been approved to enroll up to 28 U.S. patients at up to 8 institutions in the U.S., and will focus on patients with recurrent cSCC who have a weakened immune system due to any primary or secondary immunodeficiencies, excluding diabetes. For more information, please see here: View Source

Upcoming Milestones:

● Anticipating response from PMDA in Japan in Q1 2025 for pre-market approval for Alpha DaRT in patients with recurrent head and neck cancer.

● Planned release of data from pancreatic cancer trials in Canada and Israel in Q1 2025.

● Targeting completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in H1 2025. For more information, please see here: View Source

● Targeting release of data from combination trial of Alpha DaRT with pembrolizumab (Keytruda) in H1 2025. For more information, please see here: View Source

● Targeting first brain cancer treatment in H1 2025.

Financial results for quarter ended September 30, 2024

R&D expenses for the nine months ended September 30, 2024 were $19.5 million, compared to $18.9 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 nine months ended September 30, 2024 were $1.7 million, compared to $1.5 million for the same period in 2023, due to increased employee compensation and benefits.

G&A expenses for the nine months ended September 30, 2024 were $4.6 million, compared to $5.3 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 nine months ended September 30, 2024 was $3.5 million, compared to $4.0 million for the same period in 2023, due to changes in foreign exchange rates, a decrease in interest from bank deposits, and an increase in interest on long-term loan.

For the nine months ended September 30, 2024, the Company had a net loss of $22.3 million, or $0.32 per share, compared to a net loss of $21.8 million, or $0.31 per share, in the nine months of 2023.

Balance Sheet Highlights

As of September 30, 2024, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $68.4 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 November 19, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the Company has entered into an agreement under which Orion Corporation has settled all future contractual milestones, royalty and any other commitments towards Alligator in relation to two preclinical bispecific antibodies resulting from the discovery collaboration between the companies (Press release, Alligator Bioscience, NOV 19, 2024, View Source [SID1234648495]). No further development activities will be conducted under the collaboration agreement.

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"I am pleased that our successful collaboration has grown to this logical outcome. This divestiture sharpens our focus on our lead candidate mitazalimab, and this non-dilutive income constitutes an important element in advancing mitazalimab towards Phase 3" says Søren Bregenholt, CEO of Alligator Bioscience. "Following the unprecedented 18-month survival data announced earlier this year we expect several value inflection points on mitazalimab in the coming months. Notably among them, 24-months follow-up, as well as key progress in Phase 3 preparations in pancreatic cancer, which we are expected to further facilitate partnership discussions."

Van Lanschot Kempen acted as financial adviser to Alligator on the transaction.

On November 19, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that data were published on Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating AIM ImmunoTech’s drug Ampligen (also known as rintatolimod) as a component of a chemokine-modulating (CKM) regimen in early-stage triple-negative breast cancer (TNBC) (Press release, AIM ImmunoTech, NOV 19, 2024, View Source [SID1234648494]). Results of the study were reported in The Journal for ImmunoTherapy of Cancer.

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"We are very excited with these promising results from our study of a new treatment combination for patients with this most highly aggressive form of breast cancer, triple-negative breast cancer," said study principal investigator Shipra Gandhi, MD, Associate Professor of Oncology and staff physician in the Department of Medicine at Roswell Comprehensive Cancer Center. "Because this initial study was in a small number of patients, it will be important to validate these findings in a larger study."

For more information on the data reported, please visit Roswell Park’s website to read its press release titled, "Roswell Park Clinical Trial Points Toward Promising New Therapy for Most Aggressive Type of Breast Cancer."

AIM CEO Thomas K. Equels stated: "The results of this pilot study suggest that the Ampligen-containing chemokine modulation regimen is capable of modifying the tumor microenvironment and releasing cytokines that attract killer T-cells into the early-stage triple-negative breast cancer tumor. These data are similar to those we have seen with Ampligen previously in late-stage TNBC, advanced recurrent ovarian cancer and pancreatic cancer. We look forward to collaborating with Roswell Park as this study advances to Phase 2. We believe in the power of Ampligen to work in conjunction with a variety of chemotherapy regimens and/or immune checkpoint inhibitors."

For more information about the study, please visit ClinicalTrials.com: NCT04081389.

About Roswell Park Comprehensive Cancer Center

From the world’s first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. Driven to eliminate cancer’s grip on humanity, the Roswell Park team of 4,000 makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Founded in 1898, Roswell Park was among the first three cancer centers nationwide to become a National Cancer Institute-designated comprehensive cancer center and is the only one to hold this designation in Upstate New York. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email [email protected].

On November 18, 2024 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies for patients, reported it has entered into an exclusive option agreement with VelaVigo for an exclusive license to develop, manufacture and commercialize a potential first-in-class Nectin4/TROP2 bispecific antibody-drug conjugate (ADC), globally (excluding Greater China) (Press release, Avenzo Therapeutics, NOV 18, 2024, View Source [SID1234649419]). Nectin4 and TROP2 are highly co-expressed in multiple solid tumor types, including metastatic urothelial cancer.

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In addition, Avenzo has closed the final tranche of an oversubscribed Series A/A-1 financing, adding three new investors. The prior syndicate of investors, namely OrbiMed, Foresite Capital, SR One, Lilly Asia Ventures, Surveyor Capital (a Citadel company), New Enterprise Associates (NEA), Deep Track Capital, Sofinnova Investments, Sands Capital, INCE Capital, TF Capital, Delos Capital, and Quan Capital participated in this tranche, bringing the total capital raised to approximately $386 million.

"Since the formation of Avenzo, we have focused on building a pipeline of potential best- or first-in-class oncology assets. Today’s announcement brings us one step closer to our goal, and is based on the tremendous work from Scott Lipman, Chief Business Officer, and our entire team over the past 18 months," said Athena Countouriotis, M.D., Co-founder, President and CEO of Avenzo. "We continue to build our team to support our expected multiple clinical stage assets in mid-2025 and are excited to close our Series A/A-1 financing and add three new investors to our syndicate."

Under the terms of the exclusive option agreement, VelaVigo will receive an upfront fee and be entitled to receive upon the option exercise by Avenzo, an option exercise payment and potential development, regulatory, and commercial milestone payments, totaling up to approximately $800 million, as well as tiered royalties on sales in Avenzo’s territory.

An Investigational New Drug application for the Nectin4/TROP2 ADC is planned for submission to the U.S. Food and Drug Administration in mid-2025.

The company also announced the promotion of Scott Lipman, MBA to Chief Business Officer. Mr. Lipman joined Avenzo in March 2023 as Senior Vice President, Corporate Development and has led the company’s business development and strategy functions. Previously, he was on the leadership team at Turning Point Therapeutics and played an integral role in its acquisition by Bristol Myers Squibb for $4.1 billion in 2022. Mr. Lipman also worked in Healthcare Investment Banking at Goldman Sachs and started his career as a management consultant at ZS Associates. He received his B.S. in Chemical Engineering from the University of California, Los Angeles and his M.B.A. from the Kellogg School of Management at Northwestern University.

On Nov. 18, 2024 Aclaris Therapeutics, Inc. (NASDAQ: ACRS) (the "Company" or "Aclaris"), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that it has entered into a securities purchase agreement with a group of accredited investors for the private placement of 35,555,555 shares of common stock at a purchase price of $2.25 per share, for gross proceeds of approximately $80.0 million (Press release, Aclaris Therapeutics, NOV 18, 2024, View Source [SID1234648571]). The private placement is expected to close on or about November 19, 2024, subject to the satisfaction of customary closing conditions.

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The private placement was led by Vivo Capital, with participation by new and existing investors including Forge Life Science Partners, Rock Springs Capital, RA Capital Management, Adage Capital Partners LP, Decheng Capital, Logos Capital and Samsara BioCapital.

Net proceeds from the private placement are expected to fund the research and development of its pipeline and for general corporate purposes.

The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"). Accordingly, these 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. 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 sold in the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

Leerink Partners and Cantor acted as placement agents in connection with the private placement.