Good morning, ladies and gentlemen, and welcome to the FENIC Pharmaceuticals third quarter 2026 earnings and corporate update conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions on how to participate will be given at that time. As a reminder, today's conference call is being recorded. I would now like to turn the conference over to FENIC's Chief Financial Officer, Robert Andrade. Please go ahead.

Thank you, operator, and good morning, everyone. Thank you for joining us. We are pleased to host Fennec Pharmaceuticals' third quarter 2026 earnings conference call today, during which we will review our financial results as well as provide a general business update. Joining me from Fennec this morning is our Chief Executive Officer, and Board Member Jeff Hackman. Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. Reference to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the U.S. Securities and Exchange Commission. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on Fennec's website, www.fennecpharma.com. where it will be available for the next 30 days. And with that, I will now turn the call over to Jeff Hackman.

Thank you, Robert, and good morning, everyone. Thank you for joining us here today. We are pleased to report yet another quarter of revenue growth, reflecting continued progress across our business and the positive momentum that we are building around Pedmark. As we look ahead, We remain focused on executing our commercial strategy, strengthening the evidence supporting the use of Pedmark, and expanding opportunities to reach more patients who may benefit from this treatment. Today, I'd like to highlight two significant areas of progress from the quarter. First, we are realizing the benefits of the investments that we made in our Project Ignite, which is a strategic expansion of our sales organization. We did this in the first quarter of the year. We invested in 14 territories, four frontline managers to expand our ability to engage healthcare professionals, support the adoption of our product and strengthen our commercial presence across priority markets. We now have two full quarters in the field with our new territory managers and they are delivering significant productivity gains. Greater efficiency is enabling us to reach more healthcare professionals and engage them more frequently across our targeted segments. We are seeing strong uptake in the community with oncologists and we remain focused on accelerating adoption at academic centers. This momentum is strengthening our presence and relationships across these new and existing accounts. We're very encouraged by this continued progress and we believe that the productivity curve will continue to increase through the fourth quarter and through into 2027. Commercial demand continued to grow at a double-digit rate in the third quarter compared to the prior quarter, driven primarily through our Phenicures program, which is our patient services hub. Patient enrollments in Phenicures increased 23%, leading to a record number of infusions, up 58%. Thank you for joining us today. Cancer Network, or NCCN, with a 2A recommendation for use in AYA patients. As we've discussed, GPOs and their vertically integrated oncology models are an important driver of patient care in the community settings. This year, we've built upon our formulary wins by expanding our partnerships with these community practice aggregators. to access tumor-specific data and diagnosis codes for AYA patients. The data has been highly actionable. The third quarter was the first quarter for this internal alert program, which allows us to target new providers with active patients who could be appropriate for PEDMAR. Our team is becoming much more effective every month at engaging these prescribers. Using this data in the third quarter, we successfully added multiple new accounts and expanded utilization within existing ones. We anticipate the growing use of the data to be one of the fundamental drivers of adding new accounts in the community setting going forward. We are also having expanded use of PEDMARC in the academic setting. Our market access team recently secured another formulary win with a very large Midwestern academic center and their home infusion service. This inclusion enables physicians across the entire center to seamlessly prescribe Pedmark to patients at risk of CIO. The formulary win removes historical barriers to adoption and opens up the door to potentially hundreds of additional patients in this academic center alone. These types of wins are good examples of how our commercial, medical, and market access teams are working together to remove barriers and expand access across these key institutions. By increasing access in both academic and community practices, we are driving new demand and successfully changing the standard of care with Pedmark. A second area of progress is our investment in evidence generation, which is beginning to yield important scientific results. At the most recent PSYOP annual meeting, we detailed results from an investigator-initiated phase two trial, STS-J01, evaluating Pedmark for the reduction of cisplatin-induced ototoxicity in pediatric and adolescent young adults with non-metastatic tumors in Japan, where we were featured in an oral presentation. The data demonstrates significant hearing protection and provides reassurance and clinical context regarding anti-tumor activity with delayed PEDMARC administration. This represents the first public exchange of detailed results from an investigator-initiated study, and we look forward to full results from the trial being published in a peer-reviewed publication in the future. As you recall, we set a strategy in the fourth quarter of 2025 to partner with leading academic institutions to advance independent research and generate new clinical data and expand insights across additional tumor types and patient populations. We are starting to see results of these partnerships. Some exciting data forthcoming in adult and metastatic patient populations are coming. In early January, City of Hope Cancer Center plans to present interim data from its investigator-initiated study at one of the largest, most influential meetings focused on testicular cancer. The study is evaluating PEDMARC for the prevention of cisplatin-induced ototoxicity, or CIO, in adult men with stage 2 and 3 metastatic testicular germ cell tumors. We believe the interim data will provide an important opportunity to engage clinical communities and advance the discussion around PEDMARC's potential in hearing loss prevention. Additionally, City of Hope will present real-world feasibility and observe toxicity findings for PEDMARC, which utilized a deep dive into collected data from our Phenic Hears program in adults with germ cell tumors receiving platinum-based chemo. In summary, We are realizing the benefits of strategic investments and initiatives put into motion at the start of 2026, and we firmly believe PEDMARC has the potential to deliver continued sustainable growth. We are working to realize the potential through disciplined commercial execution, a growing body of evidence to support its use and ongoing operational enhancements, and designed to improve overall experience for our patients and healthcare professionals. We are confident today in the opportunity ahead and focused on turning today's progress into a long-term value for our patients, our healthcare professionals and our shareholders. And with that, I'm going to turn the call back over to Robert for a financial update.

Thank you, Jeff. Our press release contains details of our financial results for the third quarter of 2026, which can be viewed on the Investors and Media section of our website. My comments today will focus on highlighting some key financial results. Let me start by stating that Fennec just reported the best commercial quarter in its history. Entering the fourth quarter of 2026, We have the largest number of patients, planned infusions, and planned vials being carried over from the third quarter. Importantly, we have strong visibility into the strength of our fourth quarter as a result of the third quarter carryover and after a strong October. For the third quarter of 2026, the company recorded net product sales of 19.4 million compared to 12.5 million in the third quarter of 2025, representing an increase of approximately 56% year over year. We continued to build on our second quarter performance by expanding Pedmark use with both new and existing customers and the increasing productivity from our commercial team. On the OpEx side, which we define as R&D and SG&A excluding stock-based compensation, it was approximately $12.7 million for the quarter, with a year-over-year increase of about $3 million. The majority of the increase was related to the 2026 expanded marketing investment focused on awareness initiatives and increased commercial headcount supporting the growth of PEDMARC. Consistent with prior commentary for 2026, we expect the fourth quarter of 26 Cash Op X to be the lowest of the year. At Fennec, we are focused on profitability as we grow the business, and as such, are presenting record non-gap adjusted EBITDA in the third quarter of 2026 of about $5.8 million. or 30% of net product sales compared to 2 million in the comparable quarter a year ago or 16% of net product sales and up from 2.8 million in the second quarter or 16% of net product sales. As stated previously, we have significant operating leverage in the business with a predominantly fixed cost base. Our capital efficiency was evident as our EBITDA grew by $3 million on a revenue growth of $2.3 million. Importantly, in the third quarter, we generated nearly $7 million in cash from operations, a record for Fennec. EPS in the third quarter was $0.12 per share compared to a loss of $0.02 per share in the comparable quarter Cash and cash equivalents were $48.7 million as of September 30, 2026, or approximately $1.40 per share of cash, with no debt. For the avoidance of doubt, we generated approximately $0.16 per share per EBITDA this quarter alone, or an annualized run rate of 64 cents per share of EBITDA, with the potential for further margin expansion as revenues grow. Operator, with that, we are now ready to open the call for questions.

Thank you. If you would like to ask a question, please press star 1 on your telephone. You will then hear an automated message advising your hand is raised. If you would like to remove yourself, press star 1 again. We also ask that you wait for your name and company to be announced before proceeding with your question. One moment while we compile the Q&A roster. Our first question will be coming from the line of Chase Knickenbacher of Craig Killiam. Please go ahead.

Good morning. Congrats on the great quarter here and the progress. Maybe just first on the KPIs. Enrollment's up 23%. completed Infusion 58. Both those were greater than the sequential change in revenue from Q2 to Q3. Can you just help us understand kind of why and is it the time of enrollment of these patients in the third quarter? Just help us reconcile these to the top line. Thanks.

Yeah, Chase, good to hear your voice again. Yes, there are various variables as it translates from both enrollment and account growth into net revenues. One of them you mentioned, which is the timing of the enrollment and the timing of the infusion. So that carries into my fourth quarter commentary itself. The other part is also the type of patient. So as you know, we get some patients from the academic centers, some patients from the outpatient, and also some select government patients. So there's a mix there as well. But nevertheless, the momentum is strong, and I think the best KPI there are the enrollments.

Got it. Maybe second on this large Midwestern institution that you mentioned. Did you see any benefit from that in the third quarter? Maybe give us some commentary on how things have ramped in the fourth quarter, if you didn't see that benefit in the third. and then just on that center, what did, I guess, the reps do differently there to kind of get kind of wholesome buy-in at such a large institution and how can that be replicated?

Yeah.

Hey, Chase, Jeff, you know, thanks for the question. It's an exciting example of something. Your second part of the question is why now? Why this institution? Why did they move? And it's... It's a combination of our execution across not only our market access folks, which is calling on kind of the C-suite folks, right, when you think about it, our commercial organization, our MSLs, our medical science liaisons, all kind of working together over the months throughout this year to try to move physicians to utilize PEDMARC in a place like this. In this specific institution, we targeted thought leaders there. We met them at different medical meetings throughout. We conducted actually a large... and the advisory board at this institution. So all that work goes into building and getting a, you know, on formulary, for example, in an institution like this. We did see some success in the third quarter from this institution as it just got up and running, but we're seeing Significant success from this institution now moving into the fourth quarter, Chase. So you'll hear more about that, but these patients, we're just getting started there. We did, like I said, we had a few in the third, but we're starting to see some pretty significant results now as we move throughout October and into November. So stay tuned.

Got it. Last for me, Robert, just on expenses. We had previously talked about kind of a first half, second half split. Can you give us an update on kind of your thinking on cash OPEX relative to that kind of prior expectation, that split? Thanks.

Yeah, nothing has changed there as in the commentary to start. Q4 will be our lowest cash OPEX for the year. So that's going to come off of the Q3 levels of under $13 million. And the cadence is such that we should overall be in the low, which is similar to our commentary, in the low 50s in terms of full cash OpEx for the year. So we already have three quarters baked in, so we know you can do the math on what Q4 is going to be.

Helpful. Congrats again, guys. Thanks.

Thank you. One moment for the next question. Our next question will come from the line of David Anselm of Piper Sandler. Please go ahead.

Hi, good morning. This is Alex von Reisman on for David. Thanks for taking your questions. The first question, sort of following up on the first question, is what are you learning about the gap between enrollment and completed infusion and what obstacles are most limiting in terms of the conversion or Continuity of Treatment. And then secondly, we wanted to dive more into the germ cell and testicular cancer group of patients. Can you maybe refresh us on what you're seeing in the field from advocacy groups and the new field force and how penetration is in this segment? Thank you.

Perfect. I'll take a little bit of this question, I think, and then, Robert, you can jump in as well. You know, we're seeing positive trends across the business. And so those trends, we see that from just not new accounts also that we're bringing on board, but also an existing prescriber base in this engagement. And I think it's really critical to kind of understand that, that this is an ongoing business. It's not one, these patients are on therapy for a significant amount of time and so the carry that's why we can start to see carry over from one quarter to the next which gives us a lot of confidence you know as we kind of establish foundational growth here this is how we kind of move this business in that in that area so so you know we've made We've made progress in the evidence generation, which I talked about. We've really kind of focused ourselves on the medical side to try to build some impactful scientific results. And like I said, in fact, we're really diving into that data, especially into the AYA and adult metastatic area. So the germ cell tumors are important to this business to protect these patients. There's a lot of germ cell folks out there having impact to their hearing because of all the cisplatin that they're getting. So while we see this product being used in multiple tumor types, you know, the germ cells, because of so much cisplatin being given, we see an impact to their hearing.

Yeah, I'll add on both items briefly. When it comes to convergence from enrollments, this is something that we are always focused on every quarter, and that includes adherence and also the continuation of the patient. So I think our medical team and our commercial team are doing a fantastic job, as well as our partners, and you see our trends continuing to improve because generally the journey can be from four to six months. and in particular that first patient at that maybe first or new account. Our goal is to have the most positive experience possible because this is their first journey. This is their new account. So all those trends are going in a positive direction. But we ultimately start with enrollments and then go to adherence and continuation. That's the focus of the entire team. When it comes to testicular cancer, that makes up a little north of half of our business today. That is a population that obviously has a lot of exposure to cisplatinum, is in that age range that we are currently focused on. We made some good inroads. I think we touched upon one of those large institutions recently that has potential for hundreds of patients there. But we continue to look for additional inroads, advocacy groups, Awareness Initiatives, all of what we've done this entire year from ASCO to Indy's Nuts. And so we're quite pleased, but we're just scratching the surface there on that population.

Thank you. One moment for the next question, please. Our next question is coming from the line of Madison El-Sadati of B. Riley Securities. Please go ahead.

Hi guys, thanks for taking our question and congrats on the progress here. Is the 58% growth in completed infusions hub only or all channels? And relatedly, what percent of enrollment does the hub capture? And I guess how much of these total enrollments actually start and finish drugs? And then secondly, you carried a record number of patients and planned infusions into 4Q. How does that compare in percentage terms with the carry into 3Q? And any comments on what you're seeing in October? Thanks.

Sure.

Well, this is one of the most significant carryovers in from quarter to quarter that we've ever seen for the product. So that continues to grow. So that's exciting to answer the second part of that question. When you talk about enrollments and you talk about our patient adherence and what this looks like, as we started to get into this business, we tried to understand more and more about what levers it was going to be able to have to take to keep people not only to engage patients and get them on this product through their physicians, but also to keep patients on. and so we're seeing an increase with you know every single month because of the programs and the learnings and the things that we're doing to be able to keep these patients on and and to lower discontinuations and so those metrics are are better every quarter as we as we progress the business we see you know At one time we said it's about half and half where we saw patients being used phenic here's giving product at home versus in these academic or in the community settings. We see that growing. That will continue to grow on the patient, the phenic here's. or the in-home administration. It depends on the tumor type. It depends on a lot of different factors. We allow the physician to make that decision which is best for the patient. So for us, we're agnostic. We offer both of those opportunities for patients to receive product in both those settings. So, you know, is one better than the other? You know, listen, one's a little bit more hands-on on our side, you know, but again, we don't really see discontinuations or, you know, different when you look at each one of those segments of where this product's being given. I don't know, Robert, did you have a comment on it?

Yeah, Madison, I think Jeff hit most of your question, at least there. I think the start and finish component is what I was alluding to earlier, which is really the adherence and the continuation. You know, our chief commercial officer, Perry, likes to say, you know, the work really begins with the enrollment, and that speaks to having these patients continue and proper adherence. What we're carrying over, I think the other part was what we're carrying over into October is fantastic. And what we've seen, you know, and that speaks to my visibility on the fourth quarter. So as we build this business, I know we've talked about this ourselves, it's a little bit akin to doing the same store sales. So you want to build both the new accounts, the existing accounts, and also have growth on a vile basis on each existing account.

Understood, guys. That's very helpful. If I may ask one more, was the National Community Oncology Network formulary win, was that a major 3Q contributor? And do you have any, are you able to see how many of its sites are ordering things?

Yeah.

We, yes. So that was a major win for us in the third quarter. and we're planning on more of those major wins in the future here. So we can see where the product is used in a lot of cases when we utilize our PhenicHears programs. This particular institution will be utilizing their own administration, their own nurses, And so as we stay close to them, we'll get data and feedback from them as they supply it after the fact, after they bring these patients on. But we are helping them through the process of understanding. So we'll get a physician within that, for example, within that formulary group to reach out to us to talk about qualifications of patients. Is this a patient that potentially can benefit from PEDMARC? and those questions that go along with it. So we do have a vision into it. Again, each institution allows us different access, as you can imagine, but for us to get this on formulary really was a big win for us. Remember, when we built our customer, we grew our expansion of our customer-facing team, we went from about 1,300 physicians and accounts up to 5,000 in our targets when we expanded these territories. And so that's, you know, again, sometimes an institution may have four and five and six and seven, 10 targets at that institution. You know, so that's why it becomes also effective for us to get on formulary at these large institutions because it's not just one target of ours. in that account. We'll expand that throughout. And we've seen that in multiple places around the country.

And Madison, let me just clarify, because I think your question was, was it a big contributor in Q3? The answer is no. Was it a big win? Yes. And there are two points here, just to further add to the clarification. One is the Midwestern academic institution. That's potentially hundreds of patients. So You would see a big change in our revenue number, needless to say, if it was a contributor. The second component, which is a real valuable component that I know the commercial team is utilizing and getting more effective at, is this data that we are now getting from a GPO, which effectively gives you a pre-look at which cisplatin patients are in the pipeline. So it enables us to hopefully benefit, improve the quality of life of those patients that are going to be delivered cisplatinum in the very near, near future. And those two are new, so part of the optimism in the future. Got it. Thanks, guys. Great update here. Thanks.

One moment for the next question. Our next question is coming from the line of Raghuram Savaraju of HC Wainwright. Please go ahead.

Thanks for taking our questions and congratulations on this quarter. Very exciting progress. Firstly, I was wondering if you could give us some additional background color on the dynamics between academic centers and community hospitals. both of these might represent meaningful future drivers of revenue and meaningful contributors to the revenue base going forward and how you might have unique attributes of PEDMARC, of the product, of the value proposition in each of those settings. Secondly, I was wondering if you could touch upon the NCCN guideline reclassification process and how we should be thinking about the timing of that relative to the investigator-sponsored trials that are currently ongoing, and if you think this might potentially be something that could occur before the end of 2027 or further out. And then lastly, if you could give us any sense around cadence and tenor of Licensing Discussions in Japan, and when you think it might be possible for you to announce a partnership in that territory, that would be very helpful. Thank you. Perfect.

Great. Let me take a couple of these. I think you get about three sections here, and all good questions, thanks. And let me take the first one, the dynamics between academics and community. These patients are treated in obviously both settings. and so our field strategy is really designed to engage both the academic centers where treatment protocols are established in most cases, but also then in the community practices, right? Which in some cases includes networks. A large portion of the patients that we see sit in both of these sections, both of these target segments and we're seeing really traction in both areas, in both of these care models. And it's reflective on the continued quarterly growth. Is one better than the other for us? Not necessarily. I think that the academic centers in some cases will drive, will act as KOLs and thought leaders in the area, which are really important to drive those community centers. if you see what I mean. So we really, the patient demographics of what that looks like at each one varies based on the geography, but it really, really becomes exciting when you have both working together in a community. That helps with payer dynamics, it helps with customer access, It allows us to focus our concentration in a specific area, not only on that academic center, but the community centers that roll up into that academic center area. For NCCN, your second part of the question, and that's you're probably asking more about where's the movement into potentially a recommendation for NCCN for adults. And we've talked about that in the past. One of the reasons why I really wanted to start to focus our investments in driving these ISTs because there are a lot of folks out there that are asking that question, is can this product be used above AYA and into the adult marketplace? And so, for example, I mentioned in the call, City of Hope, their study is looking at older patients above AYA and they're also looking at metastatic, and so which is exciting and we believe that this product has an opportunity there as well we want to see the data and so the important thing is when is the data coming and that's when NCCN will act we believe that we've got to generate this data we're in the process of doing it we've got a large presentation that I mentioned in January which is one of the largest AYA medical meetings in the world and we'll be there presenting some preliminary data from from the City of Hope. The City of Hope will be there presenting it. So that's exciting and some of the first IST data that we're gonna see. And that will drive our adult discussions. Do we see a change in the NCCN guidelines in 2027? We can never project anything like that. We're working and showing them the data and we continue to monitor that. The third part of that question is Japan. We said one of the things, and I think I've said this in the past, is I don't want to take a deal that's not good for Fennec. And so we are in discussions. We're actively in discussions. We're actually, our chief medical officer is in Japan today. There's a large pediatric HEMOC meeting that's going on in Japan, in Yokohama. and it's exciting because all of our investigators are there. We do have some potential companies that we're talking to. They'll attend this meeting. There's a lot of action going on in Japan. So stay tuned for that. We continue to be very active in the license discussions and also how we can proceed and get this product to children. We want to get it there as fast as we can. The concern that I have is that investigators use the product in a place like this, in this region, and then it takes years to get this product to the market. So that's also something critical that we're trying to achieve as well, is get it there as fast as we can. So thank you.

Thank you. Thank you. And this concludes today's Q&A session. I would like to turn the call back to Jeff for closing remarks. Please go ahead, Jeff.

Thanks, and thanks for all the questions. We appreciate it. You know, as we look ahead, you know, all of us here remain excited about this opportunity that sits in front of us. You know, this is now our eighth consecutive quarter of growth, and it reinforces exactly what I tried to do when I came here, build the strength and consistency of our commercial execution. We believe Pedmark continues to be meaningful to our patients, and will continue to have meaningful growth potential. So thanks for joining us today. Thanks for all your interest and all your support into Fennec. And we look forward to updating you all on the progress in the quarters ahead.

This concludes today's programming. Thank you so much for joining. You may now disconnect.