Alpha Tau Medical Announces First Quarter 2024 Financial Results and Provides Corporate Update
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.
- Presented promising preclinical data showcasing abscopal immune effect in pancreatic murine tumor models.
- First patient treated in liver metastases feasibility study at McGill University Health Center.
- Ongoing patient recruitment for pivotal U.S. trial and other trials in Canada and Israel.
- Targeting completion of key trial recruitments and first treatments in various cancers throughout 2024.
- Anticipating response from Japan's PMDA for pre-market approval for Alpha DaRT in recurrent head and neck cancer.
- R&D expenses increased slightly to $6.4 million, indicating robust investment in ongoing trials.
- Marketing expenses remain low at $0.5 million, reflecting efficient use of resources.
- G&A expenses reduced to $1.4 million, showcasing cost management.
- Maintained a strong cash position of $80.7 million, sufficient to fund operations for at least two years.
- Net loss of $8.0 million for Q1 2024, slightly down from $8.2 million in the previous year.
- Reduction in cash and equivalents to $80.7 million from $84.9 million at the end of 2023.
- Increased expenses in R&D and marketing due to higher employee compensation and operational activities.
- Financial income remained flat, with higher expenses from remeasurement of warrants offsetting interest gains.
Insights
The financial results of Alpha Tau for Q1 2024 indicate a net loss of
Alpha Tau's cash balance of
From a financial perspective, the company's strategy appears sound, focusing on long-term growth through sustained investment in innovative therapies. However, the ongoing net losses and the slow revenue generation highlight that this investment is a long-term play. Investors should weigh the potential of future breakthroughs against the current financial burn rate.
The update on Alpha Tau’s clinical trials and preclinical studies showcases promising advancements in cancer treatment, particularly with their Alpha DaRT technology. The preclinical data demonstrating an abscopal immune effect in pancreatic murine tumor models is noteworthy. The abscopal effect refers to a phenomenon where local treatment of a tumor also leads to the regression of untreated metastatic tumors, mediated by the immune system. This can significantly enhance treatment efficacy, especially in difficult-to-treat cancers like pancreatic cancer.
The initiation of feasibility and safety studies in patients with liver metastases and recurrent prostate cancer, alongside ongoing recruitment for the ReSTART multi-center pivotal trial, underscores the breadth of Alpha Tau’s clinical development efforts. These studies may provide critical data that can validate the efficacy and safety of Alpha DaRT across various cancer types. The successful execution and positive outcomes of these trials could pave the way for future FDA approvals and commercial launches.
However, clinical trials are inherently risky with uncertain outcomes. Investors should remain cautious about the timelines and potential delays commonly associated with such rigorous clinical testing. Additionally, while early results are encouraging, substantial evidence of therapeutic efficacy and patient benefits will be necessary to support regulatory approvals and market adoption.
- Presented preclinical data demonstrating abscopal immune effect in pancreatic murine tumor models at ESTRO 2024 Congress in Glasgow -
- First patient with liver metastases treated in a feasibility and safety study of Alpha DaRT at the McGill University Health Center in Montreal, Canada -
- Patient recruitment for ReSTART U.S. multi-center pivotal trial and for pancreatic cancer feasibility and safety studies in Canada and Israel currently ongoing -
- Cash, cash equivalents, deposits & restricted deposits balance of $80.7 million with runway of at least two years -
JERUSALEM, May 20, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, reported first quarter 2024 financial results and provided a corporate update.
"This year we remain focused on advancing our ReSTART U.S. multi-center pivotal trial in recurrent cutaneous squamous cell carcinoma, but in parallel we have seen very encouraging initial results from our internal organ trials over the past quarter, which remind us of the broader opportunity set ahead of us,” stated Alpha Tau CEO Uzi Sofer. "Alongside our focus on completing our pivotal trial and feasibility programs, we also continue to make good progress in preparing for potential future product launches by advancing our commercial planning activities and solidifying our supply chain, with a focus on building out our new planned manufacturing facility in Hudson, New Hampshire. Alpha Tau anticipates remaining adequately capitalized to support all of these programs over the coming years," he concluded.
Recent Corporate Highlights:
- In May, preclinical data demonstrating an abscopal immune effect in pancreatic murine tumor models was presented at ESTRO 2024 Congress in Glasgow. Initial data demonstrates significant reduction in distant pancreatic cancer tumor growth rate starting from three weeks after first tumor is treated with Alpha DaRT alone. The effect was seen across both Panc02 and KPC tumor models.
- In May, the first patient with liver cancer metastases was treated in a feasibility and safety study of Alpha DaRT at McGill University Health Center in Montreal, Canada. The trial aims to recruit up to 10 patients who are eligible for a two-staged hepatectomy to resect liver metastases of colorectal cancer. For more information, please refer to https://clinicaltrials.gov/study/NCT05829291.
- In May, the first patient was treated in a clinical trial at the Rambam Health Care Campus in Haifa, Israel examining the use of Alpha DaRT for focal treatment of recurrent prostate cancer tumors. The trial aims to recruit up to 10 patients with recurrent, non-metastatic prostate adenocarcinoma. For more information, please refer to https://www.clinicaltrials.gov/study/NCT06202248.
Upcoming 2024 Milestones
- Planning treatment of the first patient in the Israeli recurrent lung cancer safety and feasibility trial in Q2 2024. The trial is currently open for recruitment; for more information please see here: https://www.clinicaltrials.gov/study/NCT05632913
- Targeting first brain cancer treatment in H2 2024.
- Targeting completion of patient recruitment in the ReSTART U.S. multi-center pivotal trial in recurrent cutaneous squamous cell carcinoma in H2 2024. The trial is currently open for recruitment; for more information please see here: https://www.clinicaltrials.gov/study/NCT05323253
- Targeting completion of patient recruitment in the Canadian advanced inoperable pancreatic cancer study in Montreal in H2 2024. The trial is currently open for recruitment; for more information please see here: https://www.clinicaltrials.gov/study/NCT04002479
- Anticipating response from PMDA in Japan by year-end 2024 for pre-market approval for Alpha DaRT in patients with recurrent head and neck cancer.
Financial results for quarter ended March 31, 2024
R&D expenses for the quarter ended March 31, 2024 were
Marketing expenses for the quarter ended March 31, 2024 were
G&A expenses for the quarter ended March 31, 2024 were
Financial income, net, for the quarter ended March 31, 2024 was
For the quarter ended March 31, 2024, the Company had a net loss of
Balance Sheet Highlights
As of March 31, 2024, the Company had cash and cash equivalents, deposits and restricted deposits in the amount of
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.
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau is an Israeli medical device company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the SEC on March 7, 2024, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release.
Investor Relations Contact:
| CONSOLIDATED BALANCE SHEET | |||||||
| U.S. dollars in thousands | |||||||
| December 31, 2023 | March 31, 2024 | ||||||
| Audited | Unaudited | ||||||
| ASSETS | |||||||
| CURRENT ASSETS: | |||||||
| Cash and cash equivalents | $ | 12,657 | $ | 7,296 | |||
| Short-term deposits | 69,131 | 70,257 | |||||
| Restricted deposits | 3,152 | 3,124 | |||||
| Prepaid expenses and other receivables | 816 | 527 | |||||
| Total current assets | 85,756 | 81,204 | |||||
| LONG-TERM ASSETS: | |||||||
| Long term prepaid expenses | 471 | 465 | |||||
| Property and equipment, net | 12,798 | 12,592 | |||||
| Right-of-use asset | 8,363 | 8,183 | |||||
| Total long-term assets | 21,632 | 21,240 | |||||
| Total assets | $ | 107,388 | $ | 102,444 | |||
| CONSOLIDATED BALANCE SHEET | ||||||||
| U.S. dollars in thousands | ||||||||
| December 31, 2023 | March 31, 2024 | |||||||
| Audited | Unaudited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade Payables | $ | 2,566 | $ | 2,459 | ||||
| Other payables and accrued expenses | 3,474 | 3,491 | ||||||
| Current maturities of operating lease liabilities | 1,062 | 1,050 | ||||||
| Total current liabilities | 7,102 | 7,000 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term loan | 5,610 | 5,526 | ||||||
| Warrants liability | 3,597 | 4,486 | ||||||
| Operating lease liabilities | 6,604 | 6,366 | ||||||
| Total long-term liabilities | 15,811 | 16,378 | ||||||
| Total liabilities | 22,913 | 23,378 | ||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Share capital | ||||||||
| Ordinary shares of no-par value per share – Authorized: 362,116,800 shares as of December 31, 2023 and March 31, 2024; Issued and outstanding: 69,670,612 and 69,796,755 shares as of December 31, 2023 and March 31, 2024, respectively | - | - | ||||||
| Additional paid-in capital | 200,234 | 202,806 | ||||||
| Accumulated deficit | (115,759 | ) | (123,740 | ) | ||||
| Total shareholders' equity | 84,475 | 79,066 | ||||||
| Total liabilities and shareholders' equity | $ | 107,388 | $ | 102,444 | ||||
| CONSOLIDATED STATEMENT OF OPERATIONS | |||||||
| U.S. dollars in thousands (except share and per share data) | |||||||
| Three months ended March 31, | |||||||
| 2023 | 2024 | ||||||
| Unaudited | |||||||
| Research and development, net | $ | 6,306 | $ | 6,448 | |||
| Marketing expenses | 400 | 533 | |||||
| General and administrative expenses | 1,938 | 1,443 | |||||
| Total operating loss | 8,644 | 8,424 | |||||
| Financial income, net | (478 | ) | (444 | ) | |||
| Loss before taxes on income | 8,166 | 7,980 | |||||
| Tax on income | 21 | 1 | |||||
| Net loss | 8,187 | 7,981 | |||||
| Net comprehensive loss | 8,187 | 7,981 | |||||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.11 | ) | |
| Weighted-average shares used in computing net loss per share, basic and diluted | 69,205,654 | 69,714,250 | |||||
FAQ
What were Alpha Tau Medical's Q1 2024 financial results?
What is Alpha Tau Medical's cash position?
What new clinical data did Alpha Tau Medical present?
What are the upcoming milestones for Alpha Tau Medical in 2024?
How is Alpha Tau Medical progressing with its ReSTART U.S. trial?
What are the financial highlights of Alpha Tau Medical's Q1 2024?
