Fennec Pharmaceuticals Inc.

Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceutical's fourth quarter in full year 2024 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. Now, I would like to turn the conference over to Fennec's Chief Financial Officer, Robert Andretti. Please go ahead.

Thank you, Operator, and good morning, everyone. We appreciate you joining us today for Fennec Pharmaceutical's fourth quarter and full year 2024 earnings conference call, 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 statement. 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 now it is my pleasure to turn the call over to Jeff Hackman. Jeff?

Hey, thank you, Robert, and good morning, everybody. Today I'm going to discuss our continued progress, including updates on our market expansion efforts, new academic endorsements, our new demographic interest, our educational investments, our operating efficiency, and our strong overall execution. All we believe will translate into significant shareholder value in 2025 and beyond. In 2024, it marked the beginning of a foundational transformation for Fennec, setting the stage for our PEDMARCH strategy. It's a strategy that we'll be utilizing throughout 2025 to realize our next phase of growth. With our recent key management and commercial hires in Q3 and Q4, we strengthened our leadership team and we enhanced our expertise. We are well positioned now to drive execution and excellence in the field, and we are already seeing encouraging momentum in early 2025. As a reminder, our first imperative was to increase our awareness around the unmet need and continuing to drive oncologists to recognize the importance of preventing cisplatin-induced ototoxicity, or CIO. Our second imperative is establishing and cementing PEDMARC as the standard of care for all CIO prevention. Next is PEDMARC's adoption. Beyond just the oncologist, Gain confidence throughout the office, first, and continued positive experiences with Pedmark. Fourth is access. Having advocacy, payers, and providers be ensured that we have seamless access for our product. And last, and equally an important pillar, is activation. Patients and caregivers are activated throughout the disease education process and realize the importance of Pedmark. One of the most exciting developments that we continue to see is the interest and adoption that we are seeing in the adolescent and young adult segment, or AYA. As mentioned previously, this opportunity for AYA is significant. In the U.S., we estimate it's approximately 20,000 cisplatin chemotherapy patients that are treated each year with the primary tumor types of thyroid, breast, germ cell, and testicular. Additionally, in contrast to the pediatric market, and based upon our market research, the USAYA oncology landscape is shaped by a combination of both academic and community centers across the nation. The key academic institutions play a critical role for establishing the treatment framework, with 72 NCI-designated academic centers that see high volume of patients across the country. In contrast, the remaining patients are treated at nearly 4,000 community practices throughout the country. The market potential for AYA is greater than the size of the pediatric market and has a favorable reimbursement profile through outpatient reimbursement efforts. We continue to be very encouraged by the response to PEDMARC from the AYA treating physicians. We are finding that most of them are acutely aware of hearing loss caused by cisplatin, but many of them are still not aware of the availability and prevention and treatment that Pedmark offers. I'm pleased to report that Pedmark is gaining traction in select major academic centers across the country. Institutions such as UCLA in California, Fred Hutchinson Cancer Center in Seattle, Mount Sinai in New York City, and Henry Ford Cancer Institute in Detroit, just to name a few examples, all have begun integrating Pedmark into their treatment plans, further validating the clinical utility and expanding patient access in real-world settings. These experiences have been very positive, and we are pleased with both the new and continued interest in Pedmark as the first and only approved therapy for the prevention of hearing loss related to cisplatin. These centers are critical in setting clinical standards, so this transition and endorsement by key institutions is a powerful signal for broader market acceptance for our product. This also opens opportunities in research settings, positioning us well for potential future expansion. As a reminder, PEDMARC is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized non-metastatic solid tumors. PEDMARC is recommended for the AYA population by the National Comprehensive Cancer Network, or the NCCN. It has a 2A endorsement. In addition, with this recommendation, as of the end of 2024, all medical compendia have received Phenix clinical updates. I'm pleased to announce that the AHFS, the largest online platform for pharmacists, has updated its content to reflect and differentiate Pedmark in accordance with our labeling. We anticipate additional compendia listings in the early 2025 and look forward to providing you all updates. Further, we continue to advance our efforts to have PEDMARC added to the NCCN Drug and Biologics Compendium, a key step in further expanding access and reimbursement pathways. As you can imagine, the process involves multiple steps. beginning with our request to modify the NCCN adolescent and young adult guidelines to expand consideration for PEDMARC in platinum based regimens beyond cisplatin. In parallel, we've also submitted a formal inclusion request to the NCCN for the neuroblastoma guidelines. Since inclusion in the compendium requires product recognition in a cancer-specific NCCN guideline, the submission is a key milestone. A decision is anticipated by mid-25, and we are actively engaging with key stakeholders to support a positive outcome here. In terms of the commercial launch and the progress, we are making significant steps outside the U.S. As previously announced, we have an exclusive licensing agreement that we've executed in March of last year, 2024, with Norgene to commercialize PedMarxi. The product is now commercially launched in both Germany and the UK in early 2025. In the UK, NICE published the list price of PedMarxi is 8,277 pounds. In Germany, the current public price is more than 10,500 euros per vial. And that final price in Germany is anticipated to happen at the end of 2025. Both markets are generating additional revenue source for Fennec in 2025 with potential for the achievement of the first two sales royalty and related milestones by the end of 2025. We look forward to providing you all updates to these recent launches as we move forward in Europe. Also on the ex-US front is the investigator-initiated trial in Japan. We call it STS-J01. It's evaluating PEDMARC and was currently enrolled and completed with enrollment in October 2024. The clinical trial STS-J01 evaluates the efficacy and safety of PEDMARC in reducing ototoxicity induced by cisplatin in children and AYAs with localized solid tumors. The primary endpoint of this trial is to assess the frequency of hearing impairment at the end of the treatment. Results of the trial are expected by the fall of 2025 with the potential evaluation of both registration and partnering or licensing of PEDMARC in Japan thereafter. Further, we've partnered with Infamous, Infarmis, excuse me, for the distribution of PEDMARC in Turkey and in the Gulf cooperated council countries. These milestones collectively mark an important step in achieving Fennec's mission of expanding our access to PEDMARC to cancer patients across the globe who all have risk of hearing loss due to Cisplatin or CIO. I want to take a moment now to just reflect on why this work and what we're doing here at Pedmark truly matters, or what we're doing here at Fennec truly matters. I recently shared at an all-company Fennec national meeting that we're not just working to preserve hearing, we're preserving connections, memories, and life itself. At Fennec, we are constantly reminded through our daily interactions with both physicians and patients of the significant importance of protecting hearing for people who are going through cancer treatment. Every cancer patient who makes it through treatment and can still hear the laughter of a loved one or just everyday sounds because of the work that we are doing to raise awareness and the importance of CIO and PEDMARC. The progress we are sharing with you today is more important than just the milestones and numbers. It's making real impact on patients' lives and their families. I'm incredibly proud of our team here at Fennec and excited about our road ahead. With that, I'm going to turn it back over to Robert.