u/Pristine_Hurry_4693

“Securing regulatory approval in Japan, specifically a PMDA stamp, can serve as a crucial gateway to broader Asian markets.

This validation is often respected by regulatory authorities across other Asian countries, smoothing market entry. This principle holds true for the ASEAN region and extends to certain nations in the Middle East as well.

Navigating these complex regulatory landscapes strategically can significantly accelerate international expansion.”

Rob Claar is the CEO of HekaBio, the partners of DRTS in Japan.

HekaBio are located in Japan, and are experts in everything to do with the medical sector, including regulations, clinical trials, commercialization and everything to do with the Japanese market.

That’s why DRTS has partnered with them years back, launched trials with them, got the the PMDA approval and are now working towards commercialization of the Alpha DaRT treatment.

That’s also why I believe it’s worth listening to what they have to say.

These aren’t remarks made about DRTS specifically, but I found them interesting and valuable because of the content and the context of who is speaking.

DRTS CEO Uzi Sofer was interviewed following the announcement that the company will be dual-listed on the Tel Aviv Stock Exchange, by different Israeli media outlets.

He shared great insights (and excitement), so here are the ones I was able to translate and believe are worth sharing.

First of all the listing came because of demand by investors. Uzi shared that he and Raphi (the CFO) have been talking to investors (and funds), and there is great interest in DRTS.

Tel Aviv being the place the Alpha DaRT treatment was developed, it’s understandable the company would have connections and potential investors worth utilizing with no fundamental downside (it’s the same shares). Having the TASE listing enables institutional money (otherwise irrelevant) to potentially participate.

The listing should become live on the 13th (so later this week).

The inclusion into indexes (it’s a strong market, this could mean many millions in buying power, realistically over $100M in buying power) could happen as soon as November (depending on timing factors, hopefully they are met).

“The listing will be without fundraising. We have $100 million in cash, which is sufficient for all our needs right now, and we expect to receive additional milestone payments from deals we have made” he said.

Regarding commercialization, he said that in Japan (where they were approved for H&N earlier this year) they are in the final stages before getting the reimbursement (which means they could be close to sales).

He mentioned they completed the recruitment in the Pivotal (“phase 3”) trial for Skin in the US, that they are now in the follow up stage, should have the results (to share and submit to the FDA) before the end of the year, and from there “the way to commercialization will be short”.

He then explained a bit about the treatment itself, how it works, and called the potential “infinite” both medically and business wise.

He explained the three pillars they decided to focus on (because it can do so much they had to start somewhere), which are recurring (and overall patients that can no longer be treated by other treatments, or that other treatments aren’t working for them, including Breast, Prostate, Skin, H&N etc), the second being high unmet needs (looking to be first line for GBM, PanC and more), and the third being metastatic (exploring the potential immune effect, that’s the combinations like Keytruda).

“Each indication can be a company in and of itself” he said, and they are getting ready with manufacturing for the future demand.

He also notes that the company is in talks with various pharma and biotech companies regarding strategic deals, but they feel that they can take this forward themselves (while being a public company, so they will need to consider serious offers).

“This company is just getting started, we are in for a magical journey”.

DRTS has partnered with HekaBio years ago, to help advance the Alpha DaRT treatment in Japan. This partnership has proven itself successful, as Alpha DaRT has been approved in Japan before the US and EU (first time ever for such a case, as discussed above and also has been mentioned before).

It seems that running a clinical track in Japan itself, has had significant impact on the treatment getting approved relatively quickly. It’s worth noting that a similar track seems to be going on in Japan for the treatment of Pancreatic Cancer with Alpha DaRT, as HekaBio has already extended it to PanC and it is also shows up on the Alpha Tau pipeline.