Alpha Tau Medical Ltd Stock Price, News & Analysis

Alpha Tau Medical (NASDAQ: DRTS, DRTSW) has been accepted into the FDA's Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to accelerate market access for Alpha DaRT® in treating recurrent glioblastoma multiforme (GBM). This follows the company's previous Breakthrough Device Designation for this indication. TAP aims to expedite patient access to innovative medical devices by providing early, frequent, and strategic communications with the FDA and facilitating engagement with key stakeholders.

The program offers tailored assistance from FDA TAP advisors to advance devices to market, focusing on product lifecycle regulation, payer coverage policies, and integration of patient insights. With an estimated 14,000 new GBM diagnoses per year in the U.S. and low five-year survival rates, Alpha Tau sees this as a important step in their strategy to treat internal organs with high unmet medical needs.

Alpha Tau Medical (NASDAQ: DRTS, DRTSW) has treated its first patient with recurrent lung cancer using the Alpha DaRT® therapy at Hadassah Medical Center in Jerusalem, Israel. The clinical trial aims to treat up to ten patients with recurrent tumors in the mediastinum area, allowing concurrent use of other therapies if indicated. The study will assess the safety and feasibility of delivering Alpha DaRT sources into the lung using an endobronchial ultrasound (EBUS) procedure, as well as evaluate the efficacy of Alpha DaRT for this indication.

Lung cancer is the leading cause of cancer-related deaths worldwide, with almost 2.5 million new cases detected annually. In the U.S., it's the third most common cancer, with an estimated 210,000 new cases per year. The Alpha DaRT treatment offers a potential new approach for patients with treatment options, especially those who have already undergone conventional radiation therapy.

Alpha Tau Medical (NASDAQ: DRTS, DRTSW) announced FDA approval of an Investigational Device Exemption (IDE) for a multi-center study using Alpha DaRT® to treat recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients. The study, led by Winship Cancer Institute of Emory University, will enroll up to 28 U.S. patients across 8 institutions.

The trial's primary efficacy objective is the objective response rate (ORR), with secondary objectives including progression-free survival, overall survival, and local control. Immunocompromised patients face a significantly higher risk of cSCC, with organ transplant recipients having a 65-100 fold greater incidence compared to the general population.

This study addresses clinician requests to treat immunocompromised patients, who are ineligible for Alpha Tau's ongoing ReSTART pivotal trial for recurrent cSCC. The company aims to provide a new potential treatment alternative for this vulnerable population.

Alpha Tau Medical (NASDAQ: DRTS, DRTSW), developer of the Alpha DaRT® alpha-radiation cancer therapy, has announced its participation in four upcoming investor conferences. CFO Raphi Levy will present at the following events:

1. H.C. Wainwright 26th Annual Global Investment Conference on September 10, 2024, in New York, NY
2. Sidoti Small-Cap Virtual Investor Conference on September 19, 2024 (virtual)
3. Redburn Atlantic and Rothschild & Co 2024 Radiopharma Conference on September 26, 2024, in New York, NY
4. Lytham Partners Fall 2024 Investor Conference on October 1, 2024 (virtual)

Mr. Levy will be available for one-on-one investor meetings at all conferences. Interested parties should contact their respective conference representatives to schedule meetings.

Alpha Tau Medical (NASDAQ: DRTS), developer of the Alpha DaRT® cancer therapy, reported Q2 2024 financial results and provided a corporate update. Key highlights include:

- First patient treated for liver metastases from colorectal cancer in May
- Publication in Cancers journal showing nearly 100% overall response rate in treated lesions
- Cash balance of $74.1 million, providing at least two years of runway
- ReSTART U.S. pivotal trial in recurrent cutaneous squamous cell carcinoma progressing
- Ongoing internal organ trials generating strong clinician interest
- New manufacturing plant in Hudson, NH approved and under renovation

Financial results for H1 2024 show R&D expenses of $13.3 million, marketing expenses of $1.1 million, and G&A expenses of $3.0 million. Net loss was $15.4 million ($0.22 per share), compared to $16.9 million ($0.24 per share) in H1 2023.

Alpha Tau announced the publication of long-term safety and efficacy data for its Alpha DaRT™ cancer therapy in the journal Cancers. The pooled analysis included 81 patients with hard-to-treat skin, head and neck, and oral cavity cancers from four international clinical trials. The results demonstrated an overall response rate of 99%, with a complete response rate of 89% and a 10% partial response rate. No moderate or severe long-term toxicities were observed, and the two-year local recurrence-free survival was estimated at 77%. Follow-up spanned up to 51 months, with a median of 14 months. The study suggests that Alpha DaRT may offer long-term disease control with minimal side effects for difficult-to-treat cancers.

Alpha Tau Medical, a leader in alpha-radiation cancer therapy, announced its participation in the Jefferies Global Healthcare Conference on June 5, 2024. Their CFO, Raphi Levy, will present a corporate overview and update at the event scheduled from 1:30 to 1:55 PM EST in New York. Levy will also be available for one-on-one meetings with investors during the conference. Attendees are encouraged to contact their Jefferies representative to schedule a session.

Alpha Tau Medical reported its Q1 2024 financials and provided a corporate update. The company presented preclinical data showcasing an abscopal immune effect in pancreatic murine tumor models at ESTRO 2024. The first patient in a liver metastases study was treated at McGill University Health Center, with recruitment ongoing for multiple trials. Financially, the company recorded R&D expenses of $6.4 million, marketing expenses of $0.5 million, and G&A expenses of $1.4 million, resulting in a net loss of $8.0 million. Alpha Tau holds $80.7 million in cash, projected to fund operations for at least two years.

Alpha Tau Medical announced the treatment of the first patient with liver cancer metastases using their innovative alpha-radiation cancer therapy, Alpha DaRT. The feasibility and safety study is being conducted at McGill University Health Center in Montreal, Canada. The trial aims to recruit up to 10 patients for a two-staged hepatectomy to resect liver metastases of colorectal cancer. The study will assess the feasibility and safety of delivering Alpha DaRT sources into the liver metastases, as well as its efficacy in terms of radiological and pathological response. CEO Uzi Sofer expressed optimism about the trial's potential to provide new therapeutic options for patients with liver metastases and other challenging cancers.