PolyPid at Lytham Partners: Strategic Advances and Financial Stability

On Thursday, 29 May 2025, PolyPid (NASDAQ:PYPD) presented at the Lytham Partners Spring 2025 Investor Conference. The company highlighted its strategic progress and financial robustness, focusing on Diplex 100, a promising product in the final stages of clinical trials. While the company boasts a strong cash position and potential market exclusivity, challenges remain in securing a US distribution partner.

Key Takeaways

• PolyPid is nearing completion of its Phase 3 trial for Diplex 100, with results expected by June 2025.
• The company holds a strong financial position with $8 million in cash and potential funding avenues exceeding $65 million.
• A US commercialization partner is actively being sought, with an announcement anticipated by year-end.
• PolyPid plans to leverage its PLEX platform for other medical applications, including OncoPlex and Immunogenesis.
• Market exclusivity for Diplex 100 could extend to eight and a half years.

Financial Results

• Cash Position: PolyPid ended the quarter with $8 million, sufficient to fund operations through Q3 2025.
• Potential Funding: The company could generate over $65 million through warrant exercises and milestone payments.

- $27 million in warrants expiring shortly after trial results at $4 per share.

- $18 million in warrants expiring January 2026 at $5.50 per share.

• Projected Runway: If all funding sources are realized, the runway extends into 2027, beyond FDA approval and market launch of Diplex 100.

Operational Updates

• Diplex 100 Clinical Trial:

- Phase 3 trial is nearing completion, with data expected by the end of June 2025.

- The trial involves 800 patients and aims to demonstrate efficacy in reducing surgical site infections.

• Manufacturing and Regulatory:

- PolyPid’s GMP manufacturing suite in Israel is ready for commercial production in Europe.

- The facility awaits FDA inspection as part of the NDA process.

- The company has secured breakthrough therapy and fast track designations, granting additional market exclusivity.

Future Outlook

• Regulatory Filings: PolyPid plans to file for FDA approval immediately after receiving trial results, followed by European approval.
• Pipeline Expansion: Focus will shift to OncoPlex and Immunogenesis once the Diplex 100 trial concludes.
• Market Expansion: The PLEX platform may be applied to other medical needs, such as local steroid delivery and GLP-1 therapies.

Q&A Highlights

• US Distribution Partner: PolyPid is in discussions with several potential partners, aiming for a deal by year-end. Partners of interest include anti-infective and medical device companies.
• Next Steps for OncoPlex and Immunogenesis: Preclinical studies for OncoPlex are planned, and collaboration with Immunogenesis continues to integrate the STING agonist molecule.
• Cash Runway: The company is well-positioned financially, with potential funding sources extending the runway into 2027.

In conclusion, PolyPid’s strategic direction and financial planning position it well for future growth. For further details, refer to the full transcript below.

Full transcript - Lytham Partners Spring 2025 Investor Conference:

Ben Chamsey, Vice President, Lithium Partners: Hello, everyone, and thank you all for joining us during for the Lithium Partners Spring twenty twenty five Investor Conference. My name is Ben Chamsey, I’m the Vice President of Lithium Partners. And today, we welcome Poly Pitt and Ori Wachowski, Chief Operating Officer, who will be taking us through slide presentation followed by a q

Ori Wachowski, Chief Operating Officer, Polypede: and a

Ben Chamsey, Vice President, Lithium Partners: discussion. Polypit trades under PYPD on the Nasdaq. With that, let’s get started. Ori, welcome, and I will turn the floor over to your presentation.

Ori Wachowski, Chief Operating Officer, Polypede: Thank you, Ben. I’m happy happy to be here. I’m, I think the audience will see that we are really at the final stages or weeks from a very meaningful milestone end of phase three with data coming, and I’ll take the audience through where we’re at and what, what to expect. Very high level, who we are and what we do. Polypede is a biopharma clinical stage biopharma with a drug delivery platform, what we call PLEX, and PLEX stands for polymer lipid encapsulation metrics.

In a nutshell, what PLEX does, PLEX can take many types of APIs from small molecules to chemotherapy all the way up to large molecules and antibodies and turn them into a local high concentration prolonged release. Lot of buzzwords. But, basically, what it means is that we can release a molecule over a duration of anywhere from days to weeks and even months of sustained linear release. Just as a comparison, some of our competitors that talk about local, release talk about seventy two hours or ninety six hours, so we are in a different scale talking about weeks and months. We have, our lead product, DIPLEX 100, at the end of phase three with data, as I mentioned, expected before the end of this quarter.

And then we have, earlier programs, in oncology, including OncoPlex. The pipeline sorry. The the platform and the products are protected by over a 70 patents. We are backwards integrated based in Israel. We have all the capabilities from r and d to regulatory to clinical to the manufacturing all in Israel.

And as Ben Ben mentioned, we are traded in Nasdaq under PYPD. A high level how Plex works. So imagine on a nanometric level, a structure that looks like an onion, layers of layers of layers of polymer that saves as a backbone and then layers of lipids. What what’s here, the this orange y white and orange pieces, lipids that surround the API, protect the API from from body fluids, from enzymes, from a harsh pH. And then what happens every time the outer layer of this onion structure comes in touch with body fluids, It disintegrates, and the API is released.

And then the next layer comes in touch with body fluid, and the API is released again and again and again. We can control we can control the number of layers, and this is how we can customize the the duration. The more layers, the longer the the duration is. We’ve con we’ve completed one phase three trial, shield shield one, in in 2022. We are in the final stages of shield two.

I’ll go over the the design and the results in in a minute. And then we have additional plans on a future expansion of the label and and and pipeline work. But the focus of this conversation is Diplex one hundred for the most part. So Diplex one hundred takes the Plex platform and combines it with doxycycline, which is a known broad spectrum antibiotic approved many years on the market, safe, with a with a target of preventing abdominal surgical site infections or SSIs. And SSIs are basically infections that come post major surgery.

It’s under this umbrella of hospital acquired infection. So a patient comes into the hospital for a surgery, whether it’s a colectomy or a joint replacement or open heart procedure. The procedure went well, but then there’s an infection. And because this infection happened within the hospital, it’s now the hospital’s responsibility to clear the infection. Everything that has to do with it from a clinical perspective, from a cost perspective, It’s all the responsibility of the hospital.

It’s a five zero five b two approval, which means we have three years of market exclusivity. We also are break we have breakthrough therapy and fast track and QIDP designations, which gives us another five years of market exclusivity. So all in all, eight years plus six months for a pediatric expansion, so we’ll have eight and a half years of exclusivity in the market. The product itself, as I mentioned, is antibiotic. We designed it.

We customized the release for thirty days of of prolonged release because the CDC guidelines of what surgical site infections are are any infections that come within the first thirty days post surgery. So we really wanted to align what the product does to what the CDC guy guidelines are and make sure that the patient gets an umbrella protection for the entire duration. You can see on the right here the total addressable market. It’s a big market, close to 12,000,000 procedures, and we can split it in into two different buckets. One are the procedures with high infection rates, like abdominal procedures, colon resection, open hernia, some of the complicated appendectomies, gynecology procedures like hysterectomy, complicated C sections, and so on.

This is one bucket when there’s high infection rates. The other bucket are procedures that infection is not as high. But if there is an infection, the consequences are really terrible. So for example, if in open heart procedure, in in a sternum procedure, if there’s an infection in a sternum bone, there’s a forty percent chance of mortality, four zero. In orthopedic procedures, if there’s an infection in in a hip replacement or knee replacement.

If there is an infection, this can mean patient in the hospital is in the hospital for four, five weeks, multiple surgeries, multiple touch points with the doctor. In worst cases, the joint is taken out, and then there’s a period of time when the patient has no no joint, and he’s completely kinda stuck to a wheelchair. So there’s quite a lot of downstream consequence that we’re trying to prevent with DPLEX one hundred. This is what it looks like in in a surgery for those who can handle it. This is Plex, the white powder.

And as you can see, the doctor at the end of the procedure, one once the the procedure is itself is done, when the surgeon is ready to close, they take the Diplex, which is a powder, mix it with saline. It turns into a a paste. It looks almost like a toothpaste, and then the surgeon or the nurse applies it directly on the incision. In this case, in this video clip here, this is open heart surgery, so applied directly on the sternum bone and then on the layers of fat, fascia, fat, muscles all the way to the skin. It’s relatively straightforward.

Doctors do it either with their their hands or with an applicator. It doesn’t really change much how the doctors close the incision today as you can see here. And then once once the duplex is administrate is administrated, it’s a onetime shot. There’s no need to reapply. There’s no need to wash everything.

From this point on, there’s thirty days of release. So if I’m looking on where we are on the clinical on the clinical, program, as I mentioned, we are at the final stages of phase three phase three. And if, I’ll try to point you so our phase three right now, shield two, is eight hundred patient comparing the standard of care, which is IV antibiotics, to DeepLex on top of standard of care. So we are not looking to replace anything, but we are adding another layer of protection. We are looking at the reduction in infection, reduction in reintervention, and reduction in mortality over thirty days, plus another sixty thirty days of safety assessment.

Now we announced last patient into the trial in March 11. So the eight hundred patient was recruited in March 11. The thirty day assessment was in April 11. The the the sixty day follow-up was in May 11 or May 10. So, basically, this path is is is finished, and what is left now is really to close all the the different patient files, make sure the data is clean, lock the data, and then let the statisticians do their work.

So we are on time. We are in the timeline, as we said, to have the results, the top line results, by the end of this quarter, June. And what we’ll be able to share at the June is basically the top line, maybe some of the sec the secondary endpoints, and some information on demographic most likely. Maybe a point on how we got to the 800 patients, we had a had an interim analysis done by an independent data safety monitoring committee or DSMB. And the role of the DSMB was twofold.

It was one, to look at the the look at the data and ensure that there are no safety issue, and two, to right size the trial for the highest probability of success. Success. And what we heard from, what we heard from the DSMB is, one, we don’t have any safety issues with with the product, and this we heard again and again over the over the the duration of the trial. And two, the the the DSMB sent us to the lowest stopping point they could. They could have sent us to anywhere from 800 patients all the way to 1,100 patients.

So the fact that they sent us to 800 patients first says that there’s there is efficacy, meaning there’s no scenario of futile trial at this point. And two, with 800 patients, we see a high probability of of success. So all to say, from from our perspective, this is a relatively derisk trial, definitely at the stage that we are at this point. The the shield one the shield two trial is is a repeat of a subpopulation of shield one. So shield one, the large incision subgroup.

And you can see these are the results of the of the shield one, and you can see really the effect on the right column across the board. The product worked as designed, showed over fifty percent reduction in primary endpoint, fifty five percent reduction in infection, forty percent reduction in mortality, fifty five percent reduction in reintervention. So, really, the product worked as designed, and we are repeating the same patient population this time around. And between that, between knowing that the product worked well in the previous phase three, the fact that the DSMB looked at the data in an unblended way, and the fact that we are that we are you know, did a lot of this lesson learned and and and refining on how we do the trial, we are very confident or feel confident in in the probability of success of this trial. We also looked on on the previous trial, we looked on how how does the product reacts to high risk patients when the risk of infection is is is greater with the thought that this is where really the main the most of the problem is, and this is where hospitals will try to use the product first.

So we look this is post hoc work, but we looked at in ShieldOne at patients that either have procedural related risk or just patient related risk, like, smokers, high BMI, diabetics, and to see how the product reacted. And what we saw is that, again, even in this high risk where the the risk of infection is is greater, the product worked well as designed with a very low p value. Again, another boost for us to feel confident about, what’s coming for us next. Finishing with the clinical, just to touch a few words on on the commercial side. So I spoke about the 12,000,000 doll 12,000,000 patient, addressable market for this product.

The parallel for that in Europe is 8,000,000 procedures in Europe. The trial shield two is designed in a way that it meets the requirements of both the FDA and the EMEA. So we’ll file for FDA for FDA approval, and immediately after that, file for a for a European approval. What is nice in Europe is that the European authorities already told us in writing that because colorectal resection is the most complicated abdominal procedure, they will use the data to give us a broad label for all abdominal procedures. So from day one, we will have access to all these abdominal procedures.

So you have the the volume here in terms in terms of pricing. We are looking at around $600 per vial. Open procedures or all in all, the the dosing is small incisions, one vial, medium sized incisions, two vial, and large incisions over 20 centimeters, three vial. On average, we like to calculate about 2.2 vials per per procedure. Maybe a point about the access and how we see the the uptake of of the product.

So I think the clinical story of DeepLex is relatively clear. If we show doctors or when I talk to doctors and talk about fifty percent reduction in infection, they understand immediately what that means for their patient, what that means for their clinic, and for their own themselves personally. The other side of this or the additional lever that we’re looking to to pull in terms of of uptake is looking at the pharmacoeconomics. What we know from literature is infection. Soft tissue infection, can cost as much as $25,000 per patient.

Infections in bone related procedures like joint replacement can cost as high as a hundred thousand dollars per surgery per patient. And it’s important to know, though, all these costs are completely paid by the hospital. Meaning, the insurers because these are inpatient procedures, the insurer pays the hospital a prenegotiated sum. Let’s take, for example, patient goes to colorectal resection. The insurer insurance pays $10,000 per the procedure.

If the patient left on time and the procedure went well, the hospital makes money. If there’s an infection and now the patient stays another seven to ten days in the hospital, all that cost, all that additional $25,000 is paid by the hospital. So our conversation in terms of access and use is really talking to the hospital and not the insuring the insurance, talking to the hospital on how can we prevent these these, very costly infection to improve the margin. In addition to that, there are programs by CMS, by Medicare to improve quality, and the the worst offenders in terms of hospital acquired infections get penalized on all their Medicare reimbursement, and this can sum up to a few million dollars per per hospital. The flip side of that is this program called NTAP, which we are eligible for new technology add on payment.

And this program reimburses CMS reimburses the hospital for up to 75% of the cost of the drug. So on one hand, on the left hand, we save money for the hospital by preventing infection. On the right hand, ENTA program reimburses the hospital for the use of the product. One more point on the on the commercial piece. We are, we have a partner in Europe, Advanced Pharma, to that, will be responsible to fully commercialize the the product.

We will we will approve it, and they will commercialize it. This is a deal that is valued at over a hundred and $10,000,000 in upfront payment, milestone payments, development milestones, and sales milestones, and royalties. Advanced Pharma is a is a hospital focused, anti infective focused company, really the the the model for what we’re looking for. And we’re looking to for partners in other markets, including The US, that will, that will commercialize the product for us. Similar structure, up fund payment, and milestone payments, and and royalties.

So we start with The US, and we’ll go to to other markets following that. Two quick points. One, we we we manufacture the product. A lot of the know how a lot of the know how for the product is how it’s manufactured. We have our own fully GMP manufacturing suite in, in Israel.

It went through a European inspection. It’s ready for European commercial manufacturing. It will go through FDA inspection as part of the NDA process. It has enough capacity. We have also plans on how to to expand capacity when when the time comes.

One touch on on on the other other molecules in in the pipeline. We signed a deal with Immunogenesis end of last year. Immunogenesis is MD Anderson based technology for solid tumors. They have a STING agonist molecule, and they showed really strong results in animals. But when they when they got to to the clinic, they saw toxicity with, with administering the the product, systemically.

So IV reached you the product reached really toxicity levels before it could impact the the tumor itself. Our collaboration will take their molecule, combine it with rPlex, inject it directly into the tumor for a prolonged release of a few weeks of a high concentration molecule, sting agonist without, the systemic toxicity that we see with the IV IV injection. So this is in early stage, and we hope to to report on this later later in the year. Final point before I open it for for questions, we had a quarterly call, q one call recently. We finished the quarter with $8,000,000, which should take us all the way to to q three this year.

So beyond the top line results, the trial is fully funded. We have enough cash to finish the trial. We have warrants that are tied to the success of the trial. So we have $27,000,000 in warrants that expire ten days after the top line results. If all the warrants are exercised, that’s another twelve twenty seven million dollars.

If the top line results is positive, we’ll get a down payment from our European partner. All in all, this should take us all the way through NDA submission and all the way up to approval. You see some of our shareholders here. No name in this space. They’ve been with us for a number of deals now, a number of years now.

We have nice coverage, and I think I think that’s it. Ben, I’m handing it over to you.

Ben Chamsey, Vice President, Lithium Partners: Alright. Thanks, Ori. Just wanted to touch on some topics. Let’s talk about the how will a positive top line, result in June impact, your US distribution, and who might be the type of partners in The US, who will be appropriate for you?

Ori Wachowski, Chief Operating Officer, Polypede: Yeah. Yeah. I think I think it’s it’s important to emphasize that we are not looking to we are not looking to, to sell this product on our own, and we are looking for partners. So we know hospital space is a complicated space. You need the experts that know how to sell in the hospital, know how to go to P and T, know how to tech talk to surgeons.

So this is this is the strategy, and some examples could be either some of the anti infective companies like a Paratek, Innoviva, or some of the other local local administered products like Pacira, Heron. These are some of the, possible names. The other type of of targets are some of the medical device companies. These guys have a infection prevention units. They are in every single surgery room in The US.

So Medtronic, J and J, Abekton, Dickinson, these are these are some of the the target the targets. I can tell you that we’ve seen really an an increase in in interest over the last few months. We have a few companies that are already in due diligence, a few of them that are in the data room already going through our some of our market research and our correspondence with the FDA really starting to build their business case. And I know I’ve I’ve been I’ve been doing this a while now. I know there there are a few companies that are sitting waiting for the the data, and, they will come in into the into the process once the data comes in.

All in all, I I target or I hope to be able to announce announce a deal before the end of the year.

Ben Chamsey, Vice President, Lithium Partners: Okay. So a positive p three announcement obviously sets the stage for DPLEX NDA and also validates the PLEX platform. What would your next next next steps be for OncoPlex, and immunogenesis?

Ori Wachowski, Chief Operating Officer, Polypede: Yeah. Yeah. So we have so we have a lot of ideas, a lot of stuff that’s in that’s in the pipe. Up until now, really, all the focus and all the resources were on, on DeepLex. Once the trial finishes, we kinda divert some of the resources to the other products.

In terms of OncoPlex, just to remind everyone, this is combining the plex platform plus plus chemotherapy, the targeting solid tumor. We already had conversations with the FDA, pre IND meeting with the FDA, on this program in glioblastoma. And, actually, the FDA suggested that this could be a first line treatment together with a resection in glioblastoma. So the next step, there’s a few there are few, preclinical studies that we we we agreed with the FDA that we should do before going into the clinic. So that’s coming up.

Immunogenesis, as I mentioned, we are now kind of in the initial stages. We are they gave us the molecule. We put it into our platform. Once we know that it releases over time as we want the profile that we want, the duration that we want, Immunogenesis will take this into preclinical models. And then if all goes well, we will go together to the clinic.

And this is where, I think, before the end of the year, we’ll be able to report some some progress on on how this is, working. But I think, overall, there’s quite a lot we can do with the platform. You know, you can think of anywhere where where local treatment is needed, frozen shoulder, or local steroids or even something like some of the GLPs, all of these ideas where where the local impact, when the long duration impact is what is needed is is areas that we can, we can play in and we can, I think, improve existing molecules?

Ben Chamsey, Vice President, Lithium Partners: Okay. Great. And I just wanna touch on the the cash runway again. You mentioned it during your presentation. But, upon you know, if you do get positive results here, talk to us about, you know, the warrants and and sort of how how that all leads to, what you guys need to do over the

Ori Wachowski, Chief Operating Officer, Polypede: next year

Ben Chamsey, Vice President, Lithium Partners: or so.

Ori Wachowski, Chief Operating Officer, Polypede: Yeah. So so a few points here. First, again, the the trial is fully funded, and and that’s that’s point number one. We we did a pipe end of last year, raised $15,000,000 with investors like, AIGH, Rosalyn, Dafna Capital. And the the the deal was structured in a way that those investors will, one, ensure that the trial is funded.

The those were the $15,000,000. And once the trial is funded, though, with our warrants that will, that will be exercised to continue to to fund the company. So ten days after top line, there are $27,000,000 of warrants that will expire at $4 a a share. There’s also another set of another $18,000,000 that expire January 2026 at $5.5 a share. So all in all, over $65,000,000 in these warrants, plus milestone payment from the from our commercial partner, Advance, for successful successful finishing the the trial, plus a potential, upfront payment from a US partner.

All in all, over $50,000,000. If all of those are exercised, this will take us well into 2027 beyond the approval and, beyond the launch.

Ben Chamsey, Vice President, Lithium Partners: Okay. Well, thank you, Uri, and thank you everyone for, watching. If you have any questions, would like to schedule, a meeting with PolyPet, please send me an email at shamsian@lithinpartners.com. That’s shamsian@lithinpartners.com. If you’d like to learn more about Lithinpartners, you can visit our website at lithinpartners.com or follow us on LinkedIn to stay connected about future events.

We hope you all enjoy the rest of the conference, have a great day. Thank

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.