PolyPid Ltd. Q4 FY2025 earnings call

• 2025 was pivotal with successful SHIELD II Phase III trial for D-PLEX100, moving it to final stages of regulatory preparation. Advancing broader platform efforts including long-acting GLP-1 Receptor Agonist program. - In regulatory progress, received positive FDA written feedback for rolling NDA submission of D-PLEX100, expecting to begin by end of Q1 2026. - Commercial front: advanced U.S. partnership discussions, participated in KOL webinar. - Appointed Brooke Story as Chairman of Board. - Ori discussed progress in U.S. commercial partner discussions, refreshed corporate brand, introduced Kynatrix technology as next-gen platform.

Fourth quarter: Research and development expenses were $6.2 million (down from $7 million in same period 2024), general and administrative expenses were $1.8 million (up from $1 million in 2024 Q4), marketing and business development expenses were $0.6 million (up from $0.2 million in prior year period), net loss was $8.5 million or $0.41 per share (same as 2024 Q4 net loss of $8.5 million but lower per share). Full year 2025: Research and development expenses totaled $23.8 million (up from $22.8 million in 2024), general and administrative expenses were $7.2 million (up from $4.3 million in 2024) due to noncash expenses from option vesting, marketing and business development expenses were $2 million (up from $0.9 million in 2024), net loss was $34.2 million or $2.09 per share (up from $29 million or $4.91 per share in 2024). As of Dec 31, 2025, cash, cash equivalents and short-term deposits were $12.9 million; subsequent warrant exercises generated $3.7 million in additional gross proceeds.

• Expect to begin rolling NDA submission for D-PLEX100 by end of Q1 2026. - 2026 has potential to be transformative for PolyPid with ongoing regulatory, partnership, and commercialization efforts. - Existing cash resources expected to fund operations into H2 2026 and through significant milestones.

• Forward-looking statements subject to numerous risks and uncertainties beyond company's control, as detailed in SEC filings, including regulatory uncertainties, commercialization challenges, etc.

Q: Maybe just a couple around the pre-NDA minutes that you received in December. Depo, would you be willing to share kind of how those discussions around the scope of the label sort of progressed? And just kind of generally, what your current expectations are as you kind of look to your proposed label as far as what we're thinking around kind of colorectal kind of specific versus a broader kind of abdominal label? And then kind of the same question around what kind of investor expectation should be potentially for some sort of risk factor or size of incision that could be on a proposed label?

A: Thank you. With regards to label, based on our discussion with the FDA we are targeting an initial label for the prevention of surgical site infections in prevention in patients undergoing abdominal colorectal surgery. This indication is directly supported by the SHIELD II Phase III data and is also our breakthrough therapy designation. We also expect that there may be an opportunity to evaluate potential label expansion into broader abdominal surgical application as we pursue -- as we go through the review process in a parallel. And the main rationale around it is as colorectal is the worst SSI prevalence in abdominal surgery. And obviously, there are other, but that's just as a high level. So that's our baseline assumption. This is how we built all of our planning and models. We do not expect on that regard anything that will narrow this. We think that this is a very conservative assumption, and this is why this is our baseline assumption. And as you referred to, we also met the FDA towards the end of last year as part of an NDA process, actually had a pre-IND communication with the FDA, where the purpose of this communication was really to align the requirement around the NDA submission, both in terms of time lines as well as in terms of having the FDA agreed that the Phase III data is adequate for NDA submission, both in terms of efficacy and safety.

Q: Congrats on the progress. Dikla, can you just talk about the work that you're doing or will be doing this year to get ready for a potential approval of D-PLEX100, both in terms of building awareness as well as getting ready with payers. Just the work that needs to be done before approval?

A: Sure, sure. So some of it, we've shared with -- in previous calls and some of it is also Ori referred to in our new branding and website. This is all part of getting ready for the commercial stage. Some of it is already out there like the website and the new branding. But also there is work that is done around packaging for D-PLEX, its commercial name that we will obviously expose later on once we are in the approval process. And in addition to that, we have been doing a lot of work, not just now, but in the last 2 years. And Ori, please feel free to add to that. whether it is in terms of market research of pricing, creating awareness, you'll start to see many more abstracts and article coming from our front during this year, building a KOL network. Just the beginning of it was with our KOL event with doctor -- or well, it was actually our KOL event, but the ROTH Group KOL event with Professor Steven D. Wexner. Ori, do you want to add anything to that?

A: I would just add that the main work right now is really, like you said, Jason, kind of putting the data out there and making sure that people are aware of the data of the product. So conferences will be a big part of it. publication will be a big part of it. A lot of the health economics piece is something that is kicking off now because, as you said, for market access, this is a driver. But also some of the on the ground kind of boots on the ground market preparation will be dependent on the partner, and we are expecting that the partner will have sufficient time, and we are -- and that's why our conversations are with kind of experienced global partners that will kind of get running immediately after signing can go on and start doing all the prior approval meetings in the hospitals and really get the access piece going almost immediately.