(NASDAQ:DRTS)
Company Overview
Confidential
Disclaimer
This presentation (together with oral statements made in connection herewith, the "Presentation") is for informational purposes only to assist interested parties in making their own evaluation with respect to Alpha Tau Medical Ltd. ("Alpha Tau" or the "Company"). By accepting this Presentation, you acknowledge and agree that all of the information contained herein or disclosed orally during this Presentation is confidential, that you will not distribute, reproduce, disclose and use such information for any purpose other than for the purpose of your firm's participation in the potential financing, that you will not distribute, reproduce, disclose or use such information in any way detrimental to Alpha Tau, and that you will return to Alpha Tau, delete or destroy this Presentation upon request.
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The information contained herein does not purport to be all-inclusive and neither the Company nor any of its respective subsidiaries, stockholders, shareholders, affiliates, representatives, control persons, partners, directors, officers, employees, advisers or agents make any representation or warranty, express or implied, as to the accuracy, completeness or reliability of the information contained in this Presentation. You should consult your own counsel and tax and financial advisors as to legal and related matters concerning the matters described herein, and, by accepting this Presentation, you confirm that you are not relying upon the information contained herein to make any decision. The reader shall not rely upon any statement, representation or warranty made by any other person, firm or corporation in making its investment or decision to invest in the Company. To the fullest extent permitted by law, in no circumstances will the Company or any of its subsidiaries, stockholders, shareholders, affiliates, representatives, control persons, partners, directors, officers, employees, advisers or agents be responsible or liable for any direct, indirect or consequential loss or loss of profit arising from the use of this Presentation, its contents, its omissions, reliance on the information contained within it, or on opinions communicated in relation thereto or otherwise arising in connection therewith. In addition, this Presentation does not purport to be all-inclusive or to contain all of the information that may be required to make a full analysis of the Company. The general explanations included in this Presentation cannot address, and are not intended to address, your specific investment objectives, financial situations or financial needs.
Use of Data
Certain information contained in this Presentation relates to or is based on studies, publications, surveys and the Company's own internal estimates and research. In addition, all of the market data included in this Presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while the Company believes its internal research is reliable, such research has not been verified by any independent source and none of the Company nor any of its affiliates nor any of its control persons, officers, directors, employees or representatives make any representation or warranty with respect to the accuracy of such information.
Forward-Looking Statements
This presentation contains forward-looking statements, including without limitation, statements related to: Alpha Tau becoming the leader in delivering innovative devices in medical technology, our ability to expand our development pipeline, opportunities to expand our portfolio through partnerships and collaborations, the progress, timing and results of our clinical trials, the safety and efficacy of our development programs, the timing of the potential approval of our products, the timing and commercial success of our products, strategies for completion and likelihood of success for our business and activities, size and growth of markets in which we may compete and potential market opportunity, and potential growth opportunities. Forward-looking statements can be identified by the words "believe," "anticipate," "continue," "estimate "project," "expect," "plan," "potential," "intends," "will," "would," "could," "should" or the negative or plural of these words or other similar expressions that are predictions or indicate future events, trends or prospects but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, among others, those inherent in the preclinical and clinical development process and the regulatory approval process, the risks and uncertainties in commercialization and gaining market acceptance, the risks associated with protecting and defending our patents or other proprietary rights, the risk that our proprietary rights may be insufficient to protect our development programs, the risk that we will be unable to obtain necessary capital when needed on acceptable terms or at all, competition from other products or procedures, our reliance on third-parties to conduct our clinical and non-clinical trials, our reliance on any third-party suppliers to manufacture clinical, non-clinical and any future commercial supplies of our products, and increased regulatory requirements. These statements are subject to the risk that clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share Alpha Tau's views of the clinical study data. There can be no assurance that the clinical studies for our development programs will be successful in demonstrating safety and/or efficacy, that we will not encounter problems or delays in clinical development, or that any of our products will ever receive regulatory approval or be successfully commercialized.
These forward-looking statements are based on information available to Alpha Tau as of the date of this presentation and speak only as of the date of this presentation. Alpha Tau disclaims any obligation to update these forward-looking statements, except as may be required by law.
This presentation is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to purchase any securities of any nature whatsoever, and it may not be relied upon in connection with the purchase of securities.
Trademarks
This presentation may contain trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners. Solely for convenience, some of the trademarks, service marks, trade names and copyrights referred to in this presentation may be listed without the TM, SM © or ® symbols, but Alpha Tau will assert, to the fullest extent under applicable law, the rights of the applicable owners, if any, to these trademarks, service marks, trade names and copyrights.
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The Alpha Tau Mission
A novel approach using localized alpha particle radiotherapy designed to precisely destroy solid tumors while sparing surrounding healthy tissue
Platform technology may be utilized alone or synergistically with other cancer treatment modalities
Radiation delivery can be customized to tumor type and geometry
Additional data from multiple clinical trials in various stages in different indications expected in 2024
First potential U.S. marketing authorization in 2025, with blockbuster market opportunity across multiple tumor types
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Confidential
Alpha Tau - Key Investment Highlights
1 | Proprietary Alpha DaRT designed to safely deliver alpha radiation with localized precision in solid tumors, sparing | |
surrounding healthy tissue | ||
2 | Broad potential and preclinical evidence supporting evaluation across various solid tumors (skin, pancreas, | |
breast, GBM, etc.) with 23 peer-reviewedpre-clinical papers | ||
3 Compelling potential immuno-stimulatory effect and synergetic combination with other therapies
4 | Over 150 superficial tumors treated to date, with strong results observed. 100% CR seen at 12 weeks in |
1st US study. Long-term pooled data analysis demonstrates 89% CR rate and 77% 2-year LRFS. | |
5 Favorable safety profile observed, no systemic toxicities, no serious late-onset toxicity.
6 | Robust clinical-trial strategy with leading global centers, with U.S. pivotal study underway in recurrent | |
cutaneous SCC. Two FDA Breakthrough Device Designations (skin & GBM) | ||
7 | Solid logistics based on purpose-built manufacturing facilities, built or in planning, in the US, Israel and Asia, | |
with a highly scalable and optimized proprietary production process | ||
8 Strong intellectual property (method and device) with over 100 issued and over 200 pending patents worldwide
9 | Experienced management team, including Alpha DaRT's co-inventors, with expertise in oncology development, |
manufacturing scale up and commercialization | |
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Confidential
Therapeutic Focus
We are focused on delivering solutions to three markets that we believe would be best served by the unique characteristics of the Alpha DaRT
Localized & Unresectable
- Localized tumors that are not surgical candidates and tumors that recur after surgery and are resistant to other therapies, specifically radiotherapy
- Alpha DaRT to be evaluated as a later line therapy
-
Tumor types include SCC, H&N
SCC and prostate
High Unmet Need
- Solid tumors that have limited treatment options with limited SOC offering
- Alpha DaRT could potentially target broad patient populations
- Tumor types include GBM and pancreatic cancer
Metastatic
- Alpha DaRT would be evaluated for its potential to induce an immune response in metastatic tumors
- Alpha DaRT would be evaluated in combination with check point inhibitors as an adjuvant therapy
- Tumor types include liver, breast and H&N (which includes lip, oral cavity, salivary glands, oropharynx & pharynx) cancers
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Confidential
Development Pipeline
- Our clinical trial strategy involves progressing our lead program (superficial tumors), particularly in the US, and conducting feasibility studies in other tumors to evaluate the Alpha DaRT in tumors of high unmet need or metastatic disease
• FDA Breakthrough Device Designation received for certain uses in skin cancer and GBM
Geography | Indication | Pre-Clinical | Feasibility | Pivotal Trial | Marketing | Anticipated Milestones | |
Research | Trial | Authorization | |||||
Rec. Cutaneous SCC | U.S. | • Complete patient recruitment 2H 2024 | |||||
North America | Pancreatic Cancer | Canada | • Interim safety readout in 4Q 2023; targeting trial | ||||
recruitment completion in 2H 2024 | |||||||
Liver Metastases | Canada | • | First patient targeted in 1H 2024 | ||||
Skin & Oral SCC | |||||||
All Skin & Oral Cancers | • Trial completion and submission | ||||||
la/mHNSCC (combo | • Feasibility combination trial with Keytruda initiated | ||||||
with pembrolizumab) | 4Q 2021; awaiting interim results | ||||||
Israel | Pancreatic Cancer | • | Feasibility trial opened | ||||
Breast Cancer | • | Feasibility trial opened | |||||
Lung Cancer | • First patient in feasibility trial targeted 1H 2024 | ||||||
Brain (GBM + mets) | • Targeting first patient in 2H 2024 | ||||||
Prostate Cancer | • Opened feasibility trial for focal treatment of | ||||||
recurrent prostate cancer | |||||||
Skin Cancers | • | Trials underway | |||||
Europe | Vulvar SCC | • Trial initiated in Q2 2023 | |||||
Pancreatic Cancer | • | Trial in planning | |||||
Japan | Head & Neck Cancer | • PMDA application sent 4Q 2023, awaiting reply | |||||
Pancreatic Cancer | • Trial in planning (TBD) | ||||||
Trials may be conducted across multiple geographies, or there may be interaction between multiple studies (e.g. pooling of long-term response data) | 6 |
Alpha DaRT Mechanism of Action and Novel | |
Platform | Delivery Techniques Make the Treatment |
Broadly Applicable | |
Technology | |
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Confidential
Types of Radioactive Decay
Due to the mass of the alpha particle, in comparison to beta particle, alpha has a low penetration power. This means that the outside layer of the human skin, for example, can block these particles.
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Confidential
Potent Alpha Radiation: Extensively Damages the DNA
Local radiation therapy with gamma or beta radiation is a mainstay of cancer treatment, but requires high local dose to be effective, as it primarily relies on single-strand breaks in a process relying on oxygen. Alpha radiation can be significantly more efficient given its ability to destroy both strands of the DNA directly, requiring lower levels of radiation
Conventional Gamma/Beta Radiation | Alpha Radiation | |
• Indirectly damaging the DNA | • Directly damaging the DNA | |
• | Dependent on oxygen presence | • Independent of oxygen presence |
• | Repairable single strand breaks | • Irreparable double strand breaks |
γ/β Radiation
O2 | Free |
Radicals | |
α Radiation |
Single Strand
Breaks
Double
Strand
Breaks
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Confidential
Alpha Radiation is Focal - Short Range Limits Clinical Use
Whereas beta and gamma radiation can penetrate tissue with sufficient range to facilitate tumor coverage (while risking damage to healthy tissue), alpha radiation has short range in tissue (<100 μm), which limits its clinical usefulness in local
delivery
Beta/Gamma Radiation | Alpha Radiation |
Long therapeutic range with risk to | Short range in tissue limits damage |
surrounding organs | to surrounding organs but also |
Healthy Tissue | limits coverage |
Healthy Tissue |
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Alpha Tau Medical Ltd. published this content on 04 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 March 2024 14:44:08 UTC.