Hello, everyone, and welcome to this next in a series of Fireside Chats here at the H.C. Wainwright Fourth Annual Bioconnect Investor Conference. My name is Ram Salvaraju, and I'm a Managing Director and Senior Healthcare Equity Research Analyst here within the Equity Research Department at Wainwright. It is my pleasure to introduce the next company, which is Fennec Pharmaceuticals. Fennec is traded on the NASDAQ under the ticker symbol FENC, and we cover Fennec with a buy rating and 12-month price target of $13 per share. Joining me here on the stage are Jeff Hackman, Chief Executive Officer, and Robert Andrade, Chief Financial Officer. Gentlemen, it's a pleasure to have you with us. So I think it would be helpful to our audience if you could provide us with an overview of Fennec Pharmaceuticals' marketed product, Pedmark, sodium thiosulfate, and the unique position that it plays within the context of oncology-supportive care.

Thanks, Ram. you know we we have the the privilege of having one of the founders here with us and so I whenever we get asked I get asked that question about tell me what what is pedmark and and I always I lean over to the guy who who spent 15 years trying to get this product approved and then I'll touch a little bit more in the second part thank you Jeff pedmark in of itself is an agent that prevents hearing loss as it's associated with cisplatinum so important to note pedmark is the first and only approved agent for the prevention of hearing loss cisplatinum itself is a chemotherapy

administered to various solid tumors across all ages from pediatric to adolescent to young adult to adults and is very effective as we say it's a mainstay in cancer as overall effectiveness rates of up to 90 percent depending on the tumor types but unfortunately it comes with a catch and as our marketing team has appropriately put a little asterisk next to survival because that's that is the hearing loss that is associated with it, which is up to 75 percent. So we've studied Pedmark for over 30 years, did two phase three trials with one of them published in the New England Journal of Medicine that statistically proved that hearing loss was reduced or at a minimum cut in half for the overall patient population. Important to note, when you are administered cisplatinum, you do not know who is going to have the hearing loss, in what form or fashion. So ultimately, our goal is that all patients are afforded the opportunity to be administered PEDMARC and to prevent that hearing loss, which is life-lasting and irreversible.

I think, Ram, just to add on to that, and we recently had a patient, a mother come talk to us whose son was treated with cisplatin and it sticks with you when you have these conversations with these patients who had to fight for, for example, having a supportive care product like this to be administered. And it's not that physicians aren't, they don't want to use Pedmark. The idea is that there's a significant amount of unawareness of what's happening out there with cisplatin. Cisplatin works incredibly well, and it has been for 40 years. And like we said, some cancers, it's doing upwards of 90% efficacious in that type of cancer. So it works really well. And oncologists, they're designed, they're trained to cure cancer. any way they can, right? But there's an asterisk, as you said, and that's up to us now to try to educate them on this. The awareness levels of PEDMARC are low. That's a good thing for us because we believe that there's significant opportunity, but there are patients out there that are losing their hearing potentially today, and we have to make that change. you know that's up to us.

I think it's important for folks to note you know I was recently at an event that Fennec kindly hosted in Indianapolis where we got to hear from not only doctors but also patients you know via interview and what is striking is the degree to which hearing loss impacts every facet of life. The treating physician who deploys cisplatin sees the good side, the response, the fact that the patient's life may have been saved. But the question then becomes, what kind of life are they left with if they can no longer hear? And I think one of the things that your chief medical officer, Pierre Sayad, who was one of the presenters at this event, said that really resonated with me is the number needed to treat with Pedmark. So I'll offer some historical context. For those of you who are not familiar, number needed to treat is a metric that defines the total number of patients who would have to be treated with a drug in order to achieve the drug's stated outcome. And in the case of, say, a drug that many of you are familiar with, atorvastatin or Lipitor, that NNT number is 220, because even though these drugs are deployed, statins are deployed in many people. I myself take one. You know, they have an effect that is very difficult to see and very difficult to measure. And that's why you have to deploy them in millions of people. But when Pierre got up on that stage, I remember him saying very proudly and emphatically that the number needed to treat with Pedmark is three. That means for every three people who get PEDmark, at least one is going to be saved the stigma and the long-term downside for the remainder of their life of irreversible hearing loss. And I think that's a key message that I want to make sure resonates with our audience today. And now this is a commercial product, you know, I have been there for most of this journey with Fenix founders, you know, how difficult it was to ultimately get the product approved, and then once it was approved, to effectively optimize the commercial messaging and the deployment. And I think, Jeff, maybe you could talk a bit through that journey and kind of how it evolved, you know, from Petmark's approval in the United States to where you are currently today and what you anticipate to be the key long-term commercial potential for the drug. And, you know, we can talk through, of course, you know, the initiatives that you have ongoing with the ISTs, et cetera, you know, to kind of make that reality. But we can start there.

Yeah, the, you know, PEDMARC was initially approved in the pediatric space, and Robert mentioned the trials that were done, and they were incredible trials. They were done with the Children's Oncology Group in the United States throughout all the major centers. and so the strategy in the beginning was to start a pediatrics sometimes what you see with some products is they start with older patients and work their way down to pediatrics but but but the the key for for this product is is almost think about it in reverse so the pediatric patients were targeted first and that's where the the approval the regulatory approval was given for this product. And the FDA gave that approval for pediatric patients, but what we saw initially was there were other people losing their hearing from cisplatin, mainly, for example, in another space called AYA, Adolescents and Young Adults, and that ranges from 15 years old to 39 years old. So what happened initially six months in after the launch or after the approval was NCCN. This group came out with what's called recommendations, a level two recommendation. And they did that recommendation on behalf of what they saw in pediatrics now for the AYA population. Well, that market is 10 times larger than the pediatric market, but you access those patients in different ways. They're not just always in the academic center. A lot of times they're treated potentially in oncology IV suites or in these offices, right? So the launch was in pediatrics and the academic institutions, and now all of a sudden the company had to shift a little bit because this opportunity existed. And so what we've tried to do since I came on board here two years ago was try to build the organization to allow that to happen, not just to be in these pediatric academic centers, but now to grow ourselves to a point where we're now on over 5,400 targets throughout the United States and build the structure to be able to administer the product, not only in these offices as well as these academic centers, but also in their homes. Remember, Robert touched on it earlier, but every time cisplatin is given, Pedmark needs to be given six hours later. And because of this six-hour delay, sometimes our product will be given at home. We needed to build what's called a program called Fennec Hears. And we're really excited about this program because it allows this product to be given in a patient's home after they had received their infusion of cisplatin, the physicians in the IV suite, for example. So, that opportunity is something that we're in the process of unlocking that. We've mentioned, we've grown our commercial organization from 10 now to 24 territories. That opportunity we're seeing play out right in front of us. We had a record first quarter, but we now have even seen a record April. And these folks have only been on for a month, you know, these new territories. So we're excited about the early green shoots of what we're seeing.

So I think just to drill down on that, you know, for our audience's edification, Fennec reported $15.1 million in top-line revenue for the first quarter of 2026. I don't want to necessarily have you make too many forward-looking statements here, but maybe you could talk through how the prescriber base has expanded since the product was originally launched, what expectations you have, especially with this scaled-up sales force for the remainder of this year, and perhaps most importantly, talk through a little bit the pricing dynamic and the implications that this could have for deployment in the community setting, especially given the advent of 340B and the fact that a lot of high-priced drugs don't make it that far. But the fact that clearly, Robert, you said this best, right? Platinum-based chemotherapy is a mainstay of chemotherapy and oncology treatment in general. I would define it as a workhorse drug that has been around for a very long time. So clearly in the community setting, that's where a lot of cisplatin gets administered. And obviously, therefore, PEDmark needs to be there. So maybe talk through some of those aspects.

Maybe you can talk through some of the numbers and then kind of touch on a little bit about the pricing.

Yeah, so important to note, since Jeff joined, we have nearly doubled our quarterly revenue. So when Jeff joined, we were around $7 million, flatlined, predominantly all pediatric. This last quarter, as Jeff said, was our record quarter. 15.1 million for the quarter. Now I stepped that back a little because if you think about that in terms of rough number of patients, we're administering on a yearly rate on that 15.1 roughly 300, maybe 400 patients in total of which 100 of them are AYA. That's 100 out of the total market size of 20 plus thousand so and again the first and only approved product for the prevention of hearing loss so no competition so that's why when we think we step back and we say well we have a product we're creating awareness in the AYA market have the awareness in the pediatric market our medical team has done a fantastic job of educating about cisplatinum, how it works, its side effects, how it impacts the cochlea. So we have the education component. Lastly, we're now we're working on the frequency, hence to Jeff's point of going from 10 territories to 24 territories. Part of the attractiveness, and Ron, forgive me if I didn't get all your questions here, in the AYA market is it's predominantly all done outpatient. So outpatient means it's going to be a cost plus model from the product. So a little different than the pediatric market, which is largely done inpatient. So we have everything aligned from awareness now, took us over a year and we're just getting going. Education, we have that recipe done. The medical team has done a wonderful job of establishing the anti-medics beforehand, the logistics, et cetera. And now we're gonna have the frequency with the team. So that bodes our enthusiasm and excitement for what's to come in the rest of 26.

I think it'd be helpful at this point to maybe educate the audience a little bit about NCCN guidelines, the National Comprehensive Cancer Network guidelines. And for those who don't know, category one is the top. That basically means NCCN's ringing endorsement, right? Immediately below that is Category 2A, which is where you folks currently are. But maybe talk through what it took to get to that category now, and also what you are planning, what is already ongoing with respect to these investigator-sponsored trials that are being done as we speak with Pedmark, and I know you have more planned, and how this effectively sort of fits into a string of pearls, if I may call it that, strategy to ultimately elevate the NCCN guidelines classification for Pedmark and perhaps most importantly let's assume let's think about a scenario in which it's no longer category 2a it's category 1 what implications does that have commercially for the product I'll peel back and I'm going to add on to a

little bit so the NCCN 2a is there's evidence that it works as you mentioned and one is the highest evidence possible. You have over 85% of the panelists that say uniformly, every time cisplatinum, or to the extent of another platinum-based chemotherapy is there, utilize Penmark. So that is the holy grail. What we have found, though, in our early indications with the 2A is that is definitely sufficient enough to get the attention of the oncologists, hence the importance of our medical team. So what we're working on with these ISTs, and I know, Ram, you sat in and listened to the City of Hope IST as an example, is phenomenal because this is going to be real-world evidence on adults, on metastatic, all the potential question marks that oncologists without the education may have. So that is what we're working towards. We have three ISTs right now up and running and enrolling. You'll hear more from us later in the year. and not only do ISTs provide the real-world evidence and potentially for the NCCN advancement, but also they stimulate the rest of the institution to think about PEDMARC, not only within the IST, but outside of the IST and even including pediatric.

And these partnerships, I call these ISTs, are partnerships that we have like the City of Hopes and the Tampa Generals now, as well as University of Arizona. These are critical partnerships for us to be able to establish as well the credibility of the company and be able to, the credibility of Pedmark, right? And we have multiple others that are going to be coming. These are all areas where we're going to look at data from these, these real world data that are really critically important for these patients. You know, we talk a lot so far about the pediatric and AYA market, but most of cisplatin is actually given in the adult space. And so there are people that are coming to us, institutions, to say, well, what about a patient at 45 years old, they want to prevent their hearing. You know, what about these patients, what are you gonna do here, you know, Fennec for these patients? And the opportunity to unlock, going back all the way to NCCN. NCCN gives recommendations. We received the two-way recommendations at AYA. The next step would be is could you achieve NCCN recommendations in the adult space? And getting to your point at the end of that question is that unlocks a significant-sized market and an unmet need. There are patients here. Why stop at 39 years of age? That's where AYA is. If I'm a 45-year-old, Don't I want to prevent hearing loss for the rest of my life? So that's a marketplace that we have to take on that responsibility to make sure this product can be given there as well.

I think it's important to delineate. First of all, correct me if I'm wrong, SIOPL-6, which was the principal registrational trial used to support the approval of PEDMARC, was an N of 114. team. These ISTs are not in hundreds or thousands of patients. They don't need to be when you have an NNT of three. Also, the investigators are highly motivated. You are choosing them based on their level of motivation to get these trials completed and get the data out there. So these are not going to be trials where we're sitting here, you know, now five years from now thinking about, oh, you know, the trial still hasn't completed enrollment.

We're never going to see the data just talk a little bit about you know kind of the cadence of results and within what time frame you expect them one of our City of Hope which started just how long ago did City of Hope just the beginning of the year just beginning of the year they have multiple patients now enrolled what you'll see is you'll have interim looks and you'll have the ability to be able to look at this data not at the end of this two year two and a half year trials that you see out here you'll be able to see those once they start to see these patients come through and see the results so you don't it's not like a typical randomized you know trial that's you know placebo-controlled these are very different and the plan is is to actually present some data in January of of next year from one of these ISTs already they were already starting to plan that so we got to get the patients enrolled and and and have that data generated but but you'll see data flowing out from all of these ISTs in these populations that that potentially need to know and need to understand that PEDMARC can be given in these populations right and be given safely I think it's important also to highlight the fact that you are building an ex-US business for PEDMARC so first talk through PEDMARC it's not called PEDMARC

in certain territories. I believe the trade name is PedMarxie. But maybe talk through PedMarxie's current status, particularly in Europe, and what infrastructure you've effectively built through partnership over there. And then also talk through what you expect to be the plan for sodium thiosulfate in Japan, where, of course, you've already generated pivotal clinical data.

So you are correct. We have currently the opportunity to benefit significantly from Pedmark or it has other branded names around the world like Pedmark's in Europe, around the world. When you say the word building, it initially triggers my mind because you think costs. Absolutely not. Our goal here is to partner. All of our infrastructure is in the U.S. But that is not taking away the opportunity in Europe, equal amount roughly of patients in Europe as in U.S. It goes by population. It goes by administration of cisplatinums. So with the Norgene partnership, we structured a nice upfront with $200 million in milestones coming to Fennec at the achievement of sales milestones or regulatory milestones, as well as with every dollar sold by Norgene, we will receive in the mid teens percent to start. Again, at very little to no cost going forward. we recently announced results out of Japan our plan is to also in the near future announce a partnership for Japan so that will our partner will launch the product in Japan and again we'll set it up such that then we have the opportunity to benefit from from the launch so there is a global opportunity maybe to put it bluntly for Fennec and for Pedmark with the focus being though of all of our FTEs here in the US we're having discussions with potential partners now in Japan the trial was kicked off you know by by my predecessor

back in 2021 it was in 10 sites in Japan it it showed similar results than the other two trials that we did around the world this study now is we believe is enough to get this product you know filed in Japan but also so as we start to think this through is is what's what's next what other territories you know the Asia Pacific area is is in discussion as you start to think about Japan and once you get there but that it's the third largest you know pharma market in the world it's an opportunity there are kids there that need this product in the country and we want to try to work as fast as we can to try to

get it there and we're excited about now all our opportunities around the world there are some other markets that are open that we believe that you know this product can have application there as well we're obviously on the edge of our seats to waiting to see you know who your Japanese partner is going to be but I want to mention to our audience that our price target our current valuation assessment gives you zero credit for potential future revenues generated by sales of Pedmark in Japan. So that's clearly something to look forward to. I think you know before we leave the Pedmark topic there's one aspect that I would love for you to elaborate on which is the expected timeframe for generic entry and in particular how that is buttressed by your recent settlement with CIPLA.

Yeah, we had some exciting news recently in the first quarter on the patent side. So let me talk about that. Thank you. You spent a lot of time working on that.

Thank you. So we were under and at litigation with a generic named CIPLA in March of this year. So just a few months ago, we settled that. So they will not be entering the market until the end of 2033. So we have a nice runway here. We're working on other potential opportunities with our formulation. In Europe, we have 10 years of market exclusivity there through what's called PUMA, or Pediatric Use Marketing Authorization. And then we have patents globally that take us through to 2039, including Japan. So I will tell you that we are very excited about our current exclusivity position and look forward to really allowing the team to focus on the execution and hopefully making and Pedmark available to as many patients as possible.

Well, thank you. I appreciate it, Ram.

One last question, if I may, Jeff. Clearly now, the product is getting its sea legs, right? You're building up a nice head of steam. There's tailwinds here. But how are you thinking strategically about the long-term future for Fennec, especially in the United States, and the extent to which you might be able to build a constellation of complementary products around Pedmark now that you've established the beachhead?

Yeah, now that, you know, we see the growth and the opportunity here, you know, we built a team that's pretty significant now at Fennec, and this commercial team has one product in their hand, and the opportunity now is what other products can we give them and put in their hands, you know, that allows them to continue to expand their capabilities out in the field. So it's our reimbursement expertise, our home health expertise, our supportive care expertise, all of our medical expertise, all of that now can be applied. So, you know, we as a company, we're looking to expand our product offerings. You know, we have, we've been approached multiple times. We're looking for the right product that fits perfectly with Pedmark and the customers that we're in. But we're excited about the future, and that's where we'll head as we continue to grow PEDMAR.

Thank you so much for sharing the Fennec story with us, gentlemen. Really, it's been a pleasure to have you with us here today, and thanks to our audience for their attention. Thank you. Thank you.