Alpha Tau Medical Announces Full Year 2023 Financial Results and Provides Corporate Update
Alpha Tau Medical Ltd. reported positive interim safety and feasibility data from a pancreatic cancer study in Montreal, entered a pivotal U.S. trial, submitted a PMDA application in Japan, and expanded its U.S. facility. The company has a strong financial position with $84.9 million in cash, providing a runway for at least two years.
The reported financial results of Alpha Tau Medical Ltd. indicate a net loss reduction from $33.8 million in 2022 to $29.2 million in 2023, which may be seen by investors as a positive trajectory in terms of narrowing losses. This is coupled with a cash balance of $84.9 million, which the company anticipates will provide a runway for at least two years. Considering the increased R&D expenses, which rose from $20.9 million to $26.4 million, stakeholders should note the company’s commitment to advancing its clinical trials. The rise in R&D is reflective of the company's strategic investments in the ReSTART trial and its expansion of clinical trials, which could potentially lead to future revenue streams upon successful product commercialization.
However, the increase in marketing expenses, although relatively small, signals the company's efforts to prepare for commercialization, which is crucial for future revenue generation. The decrease in G&A expenses from $10.3 million to $7.3 million demonstrates improved cost management. Additionally, the net financial income of $(6.5) million, a change from a net expense in the previous year, largely driven by revaluation of warrants and interest from bank deposits, contributes positively to the company's financial position.
Investors should consider the implications of these financials in light of the company's clinical progress and strategic expansion, including the addition of manufacturing facilities, which could enhance production capacity in anticipation of product approval and market demand.
The interim safety and feasibility data from the pancreatic cancer study in Montreal and the progress in the ReSTART U.S. multi-center pivotal trial are critical developments for Alpha Tau Medical Ltd. The initial signs of dose response in the pancreatic cancer trial suggest that the Alpha DaRT therapy could be effective in treating this type of cancer, which typically has a poor prognosis and limited treatment options. Stable disease responses and a partial response in patients are encouraging outcomes that could lead to significant interest from the medical community and potential for future FDA approval.
The submission of a PMDA application in Japan for recurrent head and neck cancer represents a strategic move to enter the Asian market, potentially diversifying the company's revenue sources and mitigating geographic risk. The addition of Dr. Stephen Hahn to the Scientific Advisory Board may further bolster the company's credibility and expertise in the field of radiation oncology, potentially influencing the perception of the company's scientific rigor among investors and medical professionals.
The long-term lease for a second manufacturing facility in the U.S. indicates forward-thinking in terms of production scalability. This is essential not only for meeting anticipated demand but also for mitigating risk associated with single-site production vulnerabilities. The milestones outlined for 2024, including the treatment of the first patients in liver metastases and recurrent lung cancer trials, showcase the company's aggressive pipeline development, which is an important factor for long-term growth and investor confidence.
From a market perspective, Alpha Tau Medical Ltd.'s strategic initiatives, such as the expansion of its manufacturing footprint with a second facility in the U.S., suggest an anticipation of successful commercialization and market demand for its Alpha DaRT therapy. The company's focus on difficult-to-treat internal organ tumors with high unmet need represents a targeted approach to capture niche markets that may be underserved by current therapies.
The company's projected two-year financial runway, supported by a substantial cash balance, provides it with a buffer to navigate the capital-intensive phase of clinical trials and regulatory approvals without immediate pressure to seek additional funding. This financial stability is crucial as it enters a pivotal phase of clinical development and potential market entry.
Additionally, the company's international expansion efforts, as evidenced by the PMDA submission in Japan, reflect a strategic approach to market diversification. This move could potentially reduce reliance on any single market and provide a hedge against regional regulatory risks. The anticipation of a PMDA response by year-end 2024 will be a key milestone that may influence market sentiment and the company's valuation.
03/07/2024 - 04:01 PM
- Positive interim safety and feasibility data from pancreatic cancer study in Montreal , with initial signs of potential dose response findings -
- ReSTART U.S. multi-center pivotal trial currently underway -
- Submitted PMDA application for recurrent Head and Neck cancer in Japan -
- Entered into long-term lease for a second facility in the U.S. in Hudson, NH -
- Cash , deposits and restricted deposits balance of $ 8 4 . 9 million , with anticipated runway for at least two years -
JERUSALEM, March 07, 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 full year 2023 financial results and provided a corporate update.
“2023 was an incredibly productive year, as we launched our ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma, which is expected to complete recruitment in the second half of 2024, and as we initiated a number of feasibility trials in difficult-to-treat internal organ tumors with high unmet need,” stated Alpha Tau CEO Uzi Sofer. "We saw meaningful inflection points delivered by the end of 2023, including strong interim safety and feasibility data from our pancreatic cancer trial in Montreal, with initial signs of dose response, and our PMDA submission in Japan for pre-market approval. In parallel, we continue to advance our commercial planning activities and to solidify our supply chain, which was recently bolstered by both a valuable land grant in Jerusalem that is expected to increase our future manufacturing capacity, as well as by the leasing of a second manufacturing site in the United States. In 2024, we are focused on completing patient recruitment in our U.S. pivotal ReSTART study and our pancreatic cancer pilot study in Canada, and on beginning to treat patients in studies targeting a number of other internal organs. We are also exploring the addition of new clinical trials in the U.S., based upon recent positive regulatory feedback. We expect to begin work on the construction of our second U.S. facility, in Hudson, NH, and on the construction plans for our second facility in Jerusalem. Alpha Tau expects to remain adequately capitalized to support all of these programs over the coming years.”
R ecent 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, joined its Scientific Advisory Board. In November, the Company announced that Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) accepted Alpha Tau’s submission requesting shonin pre-market approval of Alpha DaRT in patients with recurrent head and neck cancer, following multiple pre-submission consultation meetings with the PMDA per common practice in Japan. In November, the Company announced interim results from treatment of the first five patients in the Company’s safety and feasibility trial in Montreal, Canada, examining the use of Alpha DaRT to treat advanced pancreatic cancer. The Alpha DaRT procedure was deemed technically successful in all five cases, with Alpha DaRT sources successfully inserted into the target tumors. There were no reported serious adverse events deemed related to the product, and the only reported adverse events deemed possibly related to the product were of severity grade 1 (mild). In addition, despite the conservative and gradual step-up of tumor coverage from minimal initial levels, three of the five patients demonstrated stable disease responses at four weeks after treatment, and one was upgraded to partial response at 69 days after treatment. Upcoming Milestones
Planning treatment of the first patient in the Canadian liver metastases safety and feasibility trial in H1 2024. The trial is currently open for recruitment; for more information please see here: https://www.clinicaltrials.gov/study/NCT05829291 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: https://www.clinicaltrials.gov/study/NCT05632913 Targeting first brain cancer treatment in H2 2024. Targeting completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in H2 2024. 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. 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 the full year ended December 31, 202 3
R&D expenses for the year ended December 31, 2023 were $26.4 million , compared to $20.9 million in 2022, due to increased employee headcount, compensation and benefits, including share-based compensation, increased operating costs, and increased pre-clinical study and clinical trial expenses, particularly in our U.S. ReSTART trial, with a smaller offset through government grants from the Israel Innovation Authority.
Marketing expenses for the year ended December 31, 2023 were $1.9 million , compared to $1.0 million for 2022 due to increased employee compensation and benefits, including share-based compensation, and the hiring of our chief commercial officer.
G&A expenses for the year ended December 31, 2023 were $7.3 million , compared to $10.3 million for 2022, due to to decreased professional fees (including D&O insurance), and costs associated with our financing transaction in the first quarter of 2022.
Financial expenses (income), net, for the year ended December 31, 2023 were $(6.5) million , compared to $1.6 million for 2022, due to revaluation of warrants and an increase in interest from bank deposits, offset by changes in foreign exchange rates.
For the year ended December 31, 2023, the Company had a net loss of $29.2 million , or $0.42 per share, compared to a net loss of $33.8 million , or $0.53 per share, in 2022.
Balance Sheet Highlights
As of December 31, 2023, the Company had cash and cash equivalents, restricted cash and deposits in the amount of $84.9 million , compared to $105.4 million as of December 31, 2022 and $90.1 million as of September 30, 2023. The Company expects that this cash balance will be sufficient to fund 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.
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) costs related to being a public company; (xiv) risks related to Alpha Tau’s status as a foreign private issuer located in Israel, including those related to the ongoing war between Israel and Hamas and any further escalations of conflict in the Middle East; (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: IR@alphatau.com
CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands December 31, 202 2 2023 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 5,836 $ 12,657 Restricted cash 850 - Short-term deposits 98,694 69,131 Restricted deposits - 3,152 Prepaid expenses and other receivables 1,097 816 Total current assets 106,477 85,756 LONG-TERM ASSETS: Long term prepaid expenses 391 471 Property and equipment, net 7,471 12,798 Operating lease right-of-use assets 5,810 8,363 Total long-term assets 13,672 21,632 Total assets$ 120,149 $ 107,388
CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (except share and per share data) December 31, 2022 2023 LIABILITIES AND SHAREHOLDERS’ EQUITY CURRENT LIABILITIES: Trade payables $ 1,423 $ 2,566 Other payables and accrued expenses 2,246 3,474 Current maturities of operating lease liabilities 669 1,062 Total current liabilities 4,338 7,102 LONG-TERM LIABILITIES: Long-term loan - 5,610 Warrants liability 5,630 3,597 Operating lease liabilities 4,524 6,604 Total long-term liabilities 10,154 15,811 Total liabilities 14,492 22,913 COMMITMENTS AND CONTINGENCIES SHAREHOLDERS' EQUITY: Ordinary shares of no-par value per share – - - Additional paid-in capital 192,259 200,234 Accumulated deficit (86,602 ) (115,759 ) Total shareholders' equity 105,657 84,475 Total liabilities and shareholders' equity$ 120,149 $ 107,388
CONSOLIDATED STATEMENTS OF OPERATIONS U.S. dollars in thousands (except share and per share data) Year ended December 31, 2021 2022 2023 Research and development, net $ 11,447 $ 20,890 $ 26,424 Marketing expenses 482 974 1,924 General and administrative 1,861 10,272 7,332 Total operating loss 13,790 32,136 35,680 Financial expenses (income), net 13,474 1,606 (6,539 ) Loss before taxes on income 27,264 33,742 29,141 Tax on income 7 20 16 Net loss 27,271 33,762 29,157 Net comprehensive loss $ 27,271 $ 33,762 $ 29,157 Net loss per share, basic and diluted $ (0.67 ) $ (0.53 ) $ (0.42 ) Weighted-average shares used in computing net loss per share, basic and diluted 40,534,697* 63,534,875 69,377,922
* Prior period results have been retroactively adjusted to reflect the 1: 0.905292 stock split effected on March 7, 2022.
Alpha Tau Medical reported positive interim safety and feasibility data from the pancreatic cancer study in Montreal, with initial signs of potential dose response findings.
Alpha Tau entered the ReSTART pivotal U.S. multi-center trial for recurrent cutaneous squamous cell carcinoma.
Alpha Tau submitted a PMDA application for recurrent Head and Neck cancer in Japan.
Alpha Tau entered into a long-term lease for a second facility in the U.S. in Hudson, NH.
Alpha Tau had a cash, deposits, and restricted deposits balance of $84.9 million as of December 31, 2023, providing a runway for at least two years.
