Alpha Tau Medical Ltd 20-F for FY2023

Alpha Tau Medical Ltd. (DRTS)

20-F 2024-03-07 For: 2023-12-31

Added on April 12, 2026

About this 20-F

Alpha Tau Medical Ltd filed this 20-F on March 7, 2024, covering the fiscal year ended December 31, 2023 (FY2023).

Headline figures

Fiscal year ended December 31, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $29.16M; compared with a net loss of $33.76M a year earlier
Diluted EPS: -$0.42; compared with -$0.53 a year earlier

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Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Ordinary shares, no par value	DRTS	Nasdaq Stock Market LLC
Warrants to purchase ordinary shares	DRTSW	Nasdaq Stock Market LLC

ABOUT THIS ANNUAL REPORT			iii
PRESENTATION OF FINANCIAL AND OTHER INFORMATION			iii
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS			iv
PART I			1
Item 1. Identity of Directors, Senior Management and Advisers			1
Item 2. Offer Statistics and Expected Timetable			1
Item 3. Key Information			1
	A.	[Reserved.]	1
	B.	Capitalization and Indebtedness	1
	C.	Reasons for the Offer and Use of Proceeds	1
	D.	Risk Factors	1
Item 4. Information on the Company.			61
	A.	History and Development of the Company	61
	B.	Business Overview	62
	C.	Organizational Structure	113
	D.	Property, Plants and Equipment	113
Item 4A. Unresolved Staff Comments			113
Item 5. Operating and Financial Review and Prospects			113
	A.	Operating Results	117
	B.	Liquidity and Capital Resources	121
	C.	Research and Development, Patents and Licenses, Etc.	125
	D.	Trend Information	125
	E.	Critical Accounting Estimates	125
Item 6. Directors, Senior Management and Employees			127
	A.	Directors and Senior Management and Board of Directors	127
	B.	Compensation	130
	C.	Board Practices	139
	D.	Employees	151
	E.	Share Ownership	151
	F.	Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation	151
Item 7. Major Shareholders and Related Party Transactions			152
	A.	Major Shareholders	152
	B.	Related Party Transactions	154
	C.	Interests of Experts and Counsel	155
Item 8. Financial Information			156
	A.	Consolidated Statements and Other Financial Information	156
	B.	Significant Changes	156

Item 9. The Offer and Listing			156
	A.	Offer and Listing Details	156
	B.	Plan of Distribution	156
	C.	Markets	156
	D.	Selling Shareholders	156
	E.	Dilution	156
	F.	Expenses of the Issue	156
Item 10. Additional Information			157
	A.	Share Capital	157
	B.	Memorandum and Articles of Association	157
	C.	Material Contracts	157
	D.	Exchange Controls	157
	E.	Taxation	157
	F.	Dividends and Paying Agents	168
	G.	Statement by Experts	168
	H.	Documents on Display	168
	I.	Subsidiary Information	169
	J.	Annual Report to Security Holders	169
Item 11. Quantitative and Qualitative Disclosures about Market Risk			169
Item 12. Description of Securities Other than Equity Securities			169
PART II			170
Item 13. Defaults, Dividend Arrearages and Delinquencies			170
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds			170
Item 15. Controls and Procedures			170
Item 16. [Reserved]			171
Item 16A. Audit Committee Financial Expert			171
Item 16B. Code of Ethics			171
Item 16C. Principal Accounting Fees and Services			171
Item 16D. Exemptions from the Listing Standards for Audit Committees			172
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers			172
Item 16F. Change in Registrant’s Certifying Accountant			172
Item 16G. Corporate Governance			172
Item 16H. Mine Safety Disclosure			173
Item 16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections			173
Item 16J. Insider Trading Policies.			173
Item 16K. Cybersecurity			173
PART III			175
Item 17. Financial Statements			175
Item 18. Financial Statements			175
Item 19. Exhibits			175
SIGNATURES			177
INDEX

Histology	Murine Cells in Mice or in Vitro	Human Cells in Athymic Mice or in Vitro
Skin SCC	X	X
Lung SCC		X
HNSCC		X
Lung Adenocarcinoma	X	X
Pancreas Adenocarcinoma	X	X
Prostate Adenocarcinoma	X	X
Breast Carcinoma	X	X
Glioblastoma Multiforme		X
Cervical Carcinoma		X
Melanoma	X	X
Colon Carcinoma	X	X
Sarcoma	X

	●	Alpha DaRT Needle Applicator – a rigid, hypodermic needle designed in various lengths. In this applicator, the sources are affixed to a biocompatible suture and loaded inside the needle;

	●	Alpha DaRT Flex Applicator – designed for difficult geometry insertions. This applicator is in the form of a flexible (Kapton) tube, wherein the sources are strung upon a biocompatible suture and loaded inside the tube. The Flex Applicator is designed to be used in conjunction with a rigid hypodermic needle, which may be straight or curved, depending upon the specific geometry of the patient’s tumor and the physician’s preference; and

	●	Alpha DaRT Template Applicator – designed to be used together with a custom-fitted 3D-printed template molded to the patient’s tumor. The template is used as a guiding channel for rigid hypodermic needles. The sources are attached to a stainless-steel wire and loaded inside the needle. This applicator is designated for deeper tumors.

	●	our ability to demonstrate to the satisfaction of the FDA or similar foreign regulatory authorities or other bodies the safety and efficacy of our Alpha DaRT technology or any future products or product candidates, if required;

	●	educating medical personnel regarding the potential benefits and correct use of our Alpha DaRT technology;

	●	recalls, termination of distribution, administrative detention, or seizure of our products;

	●	customer notifications or repair, replacement or refunds;

	●	operating restrictions or partial suspension or total shutdown of production;

	●	delays in or refusal to grant our requests for future clearances, de novo classifications or approvals or comparable foreign marketing authorizations or certifications of new products, new intended uses, or modifications to existing products;

	●	withdrawals or suspensions of any granted marketing authorizations or certifications, resulting in prohibitions on sales of our products;

	●	FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and

	●	the U.S. federal civil and criminal false claims laws, including the civil False Claims Act, which, among other things, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. federal government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

	●	the federal civil monetary penalties laws, which impose civil fines for, among other things, the offering or transfer of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies;

	●	the U.S. federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

	●	the FDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;

	●	the U.S. Physician Payments Sunshine Act and its implementing regulations, which require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the government information related to certain payments and other transfers of value to physicians, as defined by such law, certain non-physician providers such as physician assistants and nurse practitioners, and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members;

	●	federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

	●	analogous U.S. state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require medical device and pharmaceutical companies to comply with the industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug and device manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; and state and local laws that require the registration of sales representatives; and

	●	Implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models; and

	●	collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;

	●	collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization of our product candidates based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;

	●	collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

	●	collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates;

	●	a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution;

	●	collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;

	●	disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;

	●	collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and

	●	infringement and other intellectual property misappropriation which, regardless of merit, may be expensive and time-consuming to litigate and may divert our management’s attention from our core business;

	●	substantial damages for infringement or misappropriation, which we may have to pay if a court decides that the product candidate or technology at issue infringes on or violates the third-party’s rights, and, if the court finds we have willfully infringed intellectual property rights, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees;

	●	an injunction prohibiting us from manufacturing, marketing or selling our product candidates, or from using our proprietary technologies, unless the third party agrees to license its patent rights to us;

	●	even if a license is available from a third party, we may have to pay substantial royalties, upfront fees and other amounts, and/or grant cross-licenses to intellectual property rights protecting our products; and

	●	Alpha DaRT Plant Applicator – designed for percutaneous delivery (delivery through the skin) to tumors located in organs such prostate and liver. This applicator is designed to be preloaded with the radioactive sources in accordance with a specific treatment plan.

	●	Alpha DaRT Scope Applicator – designed to be attached to an existing endoscope or bronchoscope for endoscopic delivery to tumors located in the upper and peripheral lungs. This applicator is also preloaded with the radioactive sources.

	●	Loading Device – designed to be fitted to existing needles such as standard FNA needles, for the administration of Alpha DaRT to GI organs such as the pancreas or the mediastinum. While our other applicators come preloaded and ready for deployment, the Loading Device is designed to allow the clinician to load the radioactive sources into the delivery device, such as the FNA needle, in the procedure room in the course of treatment, to select how many sources to deliver into the treatment area.

	●	Radial Applicator – designed to be fitted to existing stereotactic biopsy needles, for the administration of Alpha DaRT to the brain and potentially for other organs as well. This applicator is designed to be adapted to specific constraints in the brain, including minimizing movement in the brain when deploying Alpha DaRT sources in a circular pattern. Our goal is to ensure that such adaptor is appropriately sterilized and does not release any undesired radioactivity into the brain.

	●	establishment registration and device listing with the FDA;

	●	QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;

	●	labeling regulations and FDA prohibitions against the promotion of investigational products, or the promotion of “off-label” uses of cleared or approved products;

	●	requirements related to promotional activities;

	●	clearance or approval of product modifications to cleared devices or devices authorized through the de novo classification process that could significantly affect safety or effectiveness, or that would constitute a major change in intended use of such devices, or approval of certain modifications to PMA-approved devices;

	●	medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

	●	correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

	●	the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and

	●	post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.