Alpha Tau Medical CEO Mr. Uzi Sofer and CFO Mr. Raphi Levy were recently invited to give a presentation at the 42nd Annual JP Morgan Healthcare Conference. They came back with tons of energy and (cautious) optimism, as the excitement over their presentation and the feedback they generated in back-to-back meetings with major investors and multinational companies are all signaling that the radiotherapy market is on fire.
Mr., Uzi Sofer, CEO, and Mr. Raphi Levi, CFO, presenting at the 42nd Annual JP Morgan Healthcare Conference 2024
Raphi Levy, Alpha Tau Medical CFO for the last 4 and a half years, brings over a decade of finance leadership experience at Goldman Sachs to the role, and he is on a mission to bring Alpha Tau to be a leader in the radio-oncology therapeutic market.
We caught up with Raphi to talk about his impressions and insights from the 42nd Annual JP Morgan Healthcare Conference that just took place in San Francisco .
Can you tell us a little bit about your experience at the conference:
We had a fantastically busy week at the JP Morgan Healthcare Conference in San Francisco. From Sunday through Thursday, we had around 50 meetings, and a number of group events to meet other investors as well. The week was capped off on Thursday morning with a presentation at the conference itself, which is a big honor for us to be one of the presenting companies at the JP Morgan conference. We have seen investor receptivity increasing dramatically, both because of the growing interest in radiotherapy in general, as well as our specific data that we have released so far, including our most recent pancreatic cancer interim results.
For a market that has been relatively stagnant, what has changed this year in the radiotherapy market?
One thing we noticed has been that the focus on radiotherapy has increased exponentially, in part because of the continuing data showing that these new innovations can actually make a difference in the life of cancer patients. Data has supported the approval of Lutathera® and Pluvicto® and they have started seeing good commercial traction as well. When I joined Alpha Tau Medical four and a half years ago, radiotherapy was a space that many people would not consider, neither investors nor many of the strategic players. The data, approvals and commercial traction have all driven more interest, including a massive number of new startups trying to enter the radiopharmaceutical space. We’ve seen the rise of radiotherapy-focused investor conferences, and at this year’s JP Morgan conference we actually took part in a radiotherapy-focused cocktail event for the first time.
What is the major constraint/concern that might influence the radiopharmaceutical market dynamics?
One of the things we keep hearing relates to the poor access to radioisotopes used in manufacturing radioactive therapy drugs. When I meet investors who are more familiar with the space, one of the first questions they ask is always which isotopes we use and how we source them. This problem has been a real concern for many other companies, especially those using Actinium-225. We also witnessed Pluvicto™ sales (Novartis) halted as the company was unable to provide sufficient quantities to meet demand. Therefore, supply issues continue to remain very much on everyone's mind in the industry. We are fortunate that, in our case, we use Thorium-228 to generate Radium-224, and the Thorium-228 has not seen the same radioisotope supply issues as in other radioisotopes. The clinical reason we use Radium-224 while others use isotopes like Actinium-225 or Lutetium-177, is because most other companies use a sort of linker or conjugate to bring relatively high doses of the actinium to the proximity of the tumor and in these cases, you would want to have radioisotopes bound to the ligand and not diffusing and traveling around the body freely, so it’s advantageous to have a limited decay chain. In our case, we need a multi-step decay chain to give us the range that we see with the Alpha DaRT. Our mechanism of action is based on diffusion of radioisotopes from Radium-224 that are designed to diffuse into the cancerous tissues, emit alpha particles as part of the decay pathway, and allow the alpha particle to exert its powerful action and to reach a clinically relevant range, so the multi-step alpha decay chain is central to our mechanism. But in addition, the choice of Radium-224 and the mother isotope of Thorium-228 has worked out nicely, as we do not see the same issues on supply of our isotopes that others have seen in this space.
Alpha Tau CFO Raphi Levy: “Alpha Tau obviously stands differently positioned for the rest of these solutions, being a locally focused treatment, intratumorally injected, and therefore not reliant on a specific targeting mechanism”.
What are some of the interesting strategic transactions occurring in this market?
The clinical data, demonstrating the effectiveness of radiopharmaceuticals, together with the commercial validation that we have seen with some of these products that have launched, such as Pluvicto™ running at a rate of over a billion dollars a year in sales shortly after launch, has driven a lot of interest in the radiotherapy space. Historically, large pharmaceutical players with large cash balances have not been focused on this market, but this is changing as these companies have the need to find new pipeline assets to be able to build new revenue streams in the future. We have seen a couple of important deals happening last year. Among others we saw the J&J partnership within Nanobiotix, and the acquisition of Point Biopharma by Eli Lilly, as well as the announced acquisition of RayzeBio just before the end of the year by Bristol Myers Squibb. We have seen these major pharmaceutical companies come in and buy out radiotherapy assets in part for the specific product candidates of these companies, but also potentially to get access to the radiotherapy knowledge, supply chain, manufacturing, and handling capabilities that they would have not had in-house, in order to build a broader radiotherapy platform for the business.
How do you expect the strategic landscape to continue to evolve in the near future?
It feels as though we have now reached a point at which there is recognition of the importance of this field. There are many smaller companies starting up in the space of radiopharmaceuticals, but only a few companies have distinguished themselves and will stand right now as attractive takeover targets for some of these larger pharmaceutical companies. It is possible we will see a rush to acquire some more assets, just because if you're looking to acquire a platform on which to build a radiopharmaceutical business, there are not that many quality assets around there left to acquire. RayzeBio and Point Biopharma are certainly some of the best-known assets that were acquired, and there remain few differentiated quality assets left to support a standalone or a meaningful radiotherapy business.
Can you tell us about Alpha Tau’s position in the market?
We are left with a couple of companies still developing new pipeline products in the radiotherapy space. Most of those are similar in nature, there will be some sort of targeting mechanism conjugated or linked to a radioisotope. In many cases they are targeting similar targets, specifically PSMA for prostate cancer, or potentially neuroendocrine tumors. It is a little bit hard to see how they differentiate themselves and to know which ones will succeed clinically or which large acquirers will see as relatively attractive. Alpha Tau obviously stands differently positioned from the rest of these solutions, being a locally focused treatment, intratumorally injected, and therefore not reliant on a specific targeting mechanism as much as on our ability to deliver our Alpha DaRT sources precisely into the tumor. We are benefiting from many of the trends in the market now, as people continue to recognize the importance of radiotherapy as a potential curative treatment for cancer patients, and at the same time not competing in the same fray as other companies going after the same targets with slightly different targeting mechanisms. We also don't have the same isotope supply issues and so we continue to feel comfortable with the manufacturing capabilities in light of the Thorium-228 supply that we have access to. It feels like we are very well positioned now as we continue to generate very strong clinical data and show the potential of the Alpha DaRT as we have until now, with access to the supply that we need and with the differentiated platform on which we hope to be able to treat many solid tumors in future.
Tell us a bit about where Alpha Tau is heading in 2024?
2024 is going to be an incredibly exciting year for Alpha Tau as we continue to progress multiple clinical trials, including the US multi-center pivotal study bringing us closer towards a potential FDA approval in recurrent cutaneous squamous cell carcinoma, our pancreatic cancer trials, and other internal organ trials. Our clinical development plan and future milestones will continue to evolve as we learn more about the broad applicability of the Alpha DaRT and see enthusiastic responses from doctors to our various clinical trials. And we continue to build out our manufacturing footprint ahead of potential commercialization. There are an incredible number of things going on this year, and we look forward to delivering on those over the coming months.
Forward-Looking Statements
This article 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 9, 2023, 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.