On March 28, 2022 Alpha Tau Medical Ltd. (Nasdaq: DRTS) (Nasdaq: DRTSW), ("Alpha Tau" or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported full year 2021 financial results and provided a corporate update (Press release, Alpha Tau Medical, MAR 28, 2022, View Source [SID1234611061]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We have had an incredibly productive year, where we observed a 100% complete response rate in our multi-center U.S. pilot trial of skin cancers led by Memorial Sloan Kettering, we received two Food and Drug Administration (FDA) breakthrough device designations, one in recurrent glioblastoma and one in certain skin cancers, and we completed our acquisition of Healthcare Capital Corp and became a Nasdaq listed company," noted Alpha Tau CEO Uzi Sofer. "We are now diligently working to initiate our multi-center U.S. pivotal trial by the middle of the year, and to expand our Alpha DaRT clinical trials into additional internal organs, including the prostate cancer trial that we hope to begin imminently in Israel."
Recent Corporate Highlights:
Received FDA Breakthrough Device Designation for Alpha DaRT in June 2021 for the treatment of squamous cell carcinoma of the skin and oral cavity without curative standard of care.
Received FDA Breakthrough Device Designation for Alpha DaRT in October 2021 for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive malignant brain tumor, with an average 5-year survival rate of less than 10%.
Enrolled first patient in November 2021 in a combination trial of Alpha DaRT and pembrolizumab (Keytruda) for the treatment of recurrent unresectable or metastatic squamous cell carcinoma of the head and neck. An interim analysis is planned after the first 18 patients have been treated.
Reported results in January 2022 from the first pilot multi-center study of Alpha DaRT in the U.S., led by Memorial Sloan Kettering Cancer Center. In this trial of malignant skin and soft tissue cancer patients, a complete response, as measured by RECIST criteria, was observed in all ten out of ten tumors treated (100%), with no product-related serious adverse events reported. Alongside these data, a 98% overall response rate was observed in a pooled analysis of superficial tumors treated to date that have reached their efficacy endpoint measurement, across the Company’s various trials.
Released new pre-clinical data on the combination of Alpha DaRT with a PD-1 inhibitor, demonstrating that Alpha DART may induce responsiveness to anti-PD-1 therapy and activate T-cell function.
Completed its business combination in March 2022 with Healthcare Capital Corp., a special purpose acquisition company, raising approximately $90 million in gross proceeds and commenced trading its shares and warrants under the symbols "DRTS" and "DRTSW", respectively, on the Nasdaq Capital Market.
Upcoming Milestones
Planning to initiate a multi-center pivotal U.S. trial in skin cancers by the middle of 2022.
Planning to initiate feasibility trial in prostate cancer in Israel in second quarter of 2022.
Financial results for the full year ended December 31, 2021
R&D expenses for the year ended December 31, 2021 were $11.4 million, compared to $7.5 million in 2020, as spending increased due to expansion of the R&D team as well as increases in Alpha DaRT clinical trial activity.
Marketing expenses for the year ended December 31, 2021 were $0.5 million, compared to $0.3 million for 2020 due to increased engagement with third-party advisors and a return of marketing and conference activity that had previously decreased in 2020 due to COVID-19.
G&A expenses for the year ended December 31, 2021 were $1.9 million, compared to $1.4 million for 2020, attributed to an increase in headcount and related expenses, increased office-related expenses resulting primarily from relocation of the Company’s offices to Jerusalem, and increased audit fees in connection with preparations for public listing.
Financial expenses, net, for the year ended December 31, 2021 were $13.5 million, compared to net financial income of $0.5 million for 2020, primarily due to remeasurement of warrants, as well as changes in foreign exchange rates and a decrease in interest received from bank deposits.
For the year ended December 31, 2021, the Company had a loss attributable to ordinary shares of $27.3 million, or ($0.67) per share, compared to a loss of $8.9 million, or ($0.22) per share, in 2020. The greater loss in 2021 is primarily attributed to $13.3 million in financial expenses associated with warrant remeasurement.
Balance Sheet Highlights
As of December 31, 2021, the Company had cash and cash equivalents and deposits in the amount of $31.9 million, compared to $46.6 million at December 31, 2020. Subsequently, in March 2022 Alpha Tau raised gross proceeds of approximately $90 million from the Business Combination. 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 source 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.