On November 16, 2023 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 2023 financial results and provided a corporate update (Press release, Alpha Tau Medical, NOV 16, 2023, View Source [SID1234637731]).
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"This year has already seen tremendous progress, as we advance our ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma, which is expected to produce data in 2024, and continue to initiate a series of feasibility trials in difficult-to-treat internal organ tumors with high unmet need, such as pancreatic and liver cancers," stated Alpha Tau CEO Uzi Sofer. "We are looking forward to meaningful inflection points during the rest of 2023, including interim safety and feasibility data from our pancreatic cancer trial in Montreal, and our forthcoming submission in Japan for pre-market approval. In parallel, we are preparing for future product launches by advancing our commercial planning activities and solidifying our supply chain, which was recently bolstered by a valuable land grant in Jerusalem that is expected to increase our future manufacturing capacity as well as the leasing of a second manufacturing site in the U.S. Alpha Tau remains adequately capitalized to support all of these programs over the coming years," he concluded.
Recent Corporate Highlights:
● In October, the Company announced that it had entered into a long-term lease agreement for a standalone building of over 14,000 rentable square feet in Hudson, NH, with the intention of erecting the Company’s second U.S. manufacturing site, alongside its first site in nearby Lawrence, MA.
● In October, the Company announced that Dr. Stephen Hahn, a former commissioner of the U.S. Food and Drug Administration (FDA) and a distinguished expert in the field of radiation oncology and translational clinical research, has joined its Scientific Advisory Board.
● In September, the first patient with advanced inoperable pancreatic cancer was treated with Alpha DaRT at Hadassah Medical in Jerusalem, Israel, in parallel to the Company’s ongoing safety and feasibility trial for the treatment of advanced inoperable pancreatic cancer currently underway in Montreal, Canada.
● In August, Alpha Tau reported long-term safety and tumor control outcomes data for patients with unresectable, recurrent, or locally advanced head and neck or skin tumors treated with Alpha DaRT across four prospective trials conducted at several international institutions. In this analysis, 81 lesions were treated in 71 patients. The median follow-up was 14 months (range: 2-51 months). A complete response (CR) was observed in 89% of treated lesions (n=72), 10% (n=8) demonstrated a partial response, and one patient was not evaluable. The two-year actuarial local recurrence-free survival (LRFS) rate was 77% [95% CI: 63–87%]. Twenty percent of patients developed treatment-related acute grade 2 toxicity (such as dermatitis radiation, local pain at the treatment site or pruritus), which subsequently resolved with conservative treatment; there were no grade 3 or higher related acute toxicities reported. There were no grade 2 or higher ‘late toxicities’, defined as toxicities occurring six months after Alpha DaRT treatment or later, observed in this cohort.
Upcoming Near-Term Milestones
● Expecting to release interim safety and feasibility data in Q4 2023 from the first five patients treated in the Company’s study examining the use of Alpha DaRT to treat patients in Montreal, Canada with advanced inoperable pancreatic cancer. For more information please see here: View Source
● Expecting to submit to the PMDA in Japan in Q4 2023 for pre-market approval for Alpha DaRT in patients with recurrent head & neck cancer.
● Planning treatment of the first patient in the Canadian liver metastases safety and feasibility trial in Q4 2023 or Q1 2024. The trial is currently open for recruitment; for more information please see here: View Source
● Planning treatment of the first patient in the Israeli recurrent lung cancer safety and feasibility trial in H1 2024. The trial is currently open for recruitment; for more information please see here: View Source
● Targeting first brain cancer treatment in H1 2024.
● Targeting completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q2 2024. For more information please see here: View Source
Financial results for nine months ended September 30, 2023
R&D expenses for the nine months ended September 30, 2023 were $18.9 million, compared to $15.5 million for the same period in 2022, due to increased employee compensation and benefits, including share-based compensation, increased pre-clinical study and clinical trial expenses particularly in our U.S. multi-center pivotal trial, and reduced government grants, offset by lower expenses in Japan because of the completion of our clinical study in Japan last year.
Marketing expenses for the nine months ended September 30, 2023 were $1.5 million, compared to $0.6 million for the same period in 2022, due to increased employee compensation and benefits, including share-based compensation for marketing personnel including our chief commercial officer hired in 2022, as well as increased marketing activities.
G&A expenses for the nine months ended September 30, 2023 were $5.3 million, compared to $8.1 million for the same period in 2022, due to decreased compensation expenses as well as one-time expenses in 2022 associated with the Company’s merger with Healthcare Capital Corp.
Financial income, net, for the nine months ended September 30, 2023 was $4.0 million, compared to financial expense, net of $6.2 million, for the same period in 2022, due to a decrease in remeasurement of warrants, an increase in interest from bank deposits, and changes in foreign exchange rates.
For the nine months ended September 30, 2023, the Company had a net loss of $21.8 million, or $0.31 per share, compared to a net loss of $30.4 million, or $0.49 per share, in the same period of 2022.
Balance Sheet Highlights
As of September 30, 2023, the Company had cash, restricted cash, deposits and restricted deposits in the amount of $90.1 million, compared to $105.4 million on December 31, 2022. The Company expects that this cash balance will be sufficient to fund operations for at least two years.