Hi, everyone. Thank you for joining the H.C. Wainwright 26th Annual Global Investment Conference. My name is Vivian Chang. I'm an analyst on the corporate access team. H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across various sectors. From a logistics standpoint, please make sure to reference your online conference portal that'll provide your updated schedules. With that said, we wish you a productive rest of the conference. Now, I will hand it off to Robert Andrade, the Chief Financial Officer of Fennec Pharmaceuticals.
Thank you, and thank you to H.C. Wainwright for the conference. I'm gonna be going through a deck, which you can find on our website at www.fennecpharma.com. So all these slides will be available on our website. This is our standard safe harbor statement. We are a public company. We have public filings on sec.gov, which I refer you to, and at sedar.com. So what is Fennec? Fennec is a commercial-stage company dedicated to improving the lives of children and adolescents with cancer. We have one product. That's that product on the right. It is Pedmark, it is FDA approved in the U.S., and it is EMA approved in Europe. We had approval about two years ago, and it's for the prevention of ototoxicity or hearing loss associated with cisplatin in pediatric patients one month of age and older.
We launched the product about two years ago, in October 2022, and it is our own unique formulation of sodium thiosulfate, specifically developed and tested in pediatrics. As I mentioned, in Europe, we got approval in June 2023. We were excited to announce a partnership and a licensing agreement in March 2024 with Norgine. Norgine will be commercializing Pedmarqsi, which is the European brand name for Pedmark, in Europe, Australia, and New Zealand here shortly. With that licensing agreement, there was $43 million in upfront cash, which is on our balance sheet, and the potential of up to $230 million in milestone payments and tiered royalties up to the mid-twenties on all net sales within those territories. In Europe, we have 10 years of exclusivity under PUMA, or Pediatric Use Marketing Authorization.
Further adding to that, our IP includes six Orange Book patents here in the U.S., several patents pending internationally, and seven years of U.S. market exclusivity through ODE or Orphan Drug Exclusivity. To get to approval, we were successful in two phase III trials. One was SIOPEL 6, largely taking place in Europe. That trial was published in the New England Journal of Medicine. The other one was COG ACCL0431, largely taking place in the U.S. Both trials, as you can see here, reduced the relative risk of hearing loss by approximately 50%. On average, a patient not utilizing Pedmark would have about 60% hearing loss versus the 30% when they utilized Pedmark.
You can see the manageable safety profile on the right of this slide, common, including vomiting and nausea, largely treated with pre-hydration prior to administration and some antiemetics. So for those of you that aren't familiar with cisplatin, cisplatin's been around for decades. It's known as the penicillin of chemotherapy. It is common in those tumors you can see on the right with children, including neuroblastoma, hepatoblastoma, osteosarcoma, and germ cell. In adolescents and in young adults, one of the larger uses is for testicular cancer. One of the unfortunate complications, here you can see visually, with cisplatin is the loss of hearing. Again, prior to Pedmark, there was nothing to prevent this loss of hearing. The only option was after you had hearing loss, which is irreversible.
Some of those options on the left, you can see what a cochlear ear implant looks like on that patient, and then you can. You're familiar with hearing aids. As mentioned, cisplatin results in high-frequency hearing loss in children. It can also be accompanied by tinnitus. It is progressive, it is irreversible, and it has a long-lasting impact on the life of patients. Hearing loss can occur incredibly early in treatment, as early as the first or second dose of cisplatin. Survivors, furthermore, are at risk of hearing deterioration years and years after cisplatin. Prior to Pedmark, the hearing loss could be dose-limiting for the cisplatin, meaning that the efficacy of the chemotherapy could be compromised. Probably familiar with many of you, once you lose your hearing, it's lifelong impacting.
It has career limitations, speech impairment, social isolation, development delays. Hearing loss has been associated with lower IQ, inability for phonetic decoding, and low reading comprehension. cisplatin, as mentioned, is very, very successful, on a localized basis, for overall survival for the patients, greater than 80% survival. Unfortunately, prior to Pedmark, there were no interventions that could prevent the hearing associated with the cisplatin, and very poor, both monitoring and follow-up from an audiology perspective. North of 60% of patients, of children, develop irreversible ototoxicity. This slide depicts the risk from minimal hearing loss of being held back a grade. You can see the bars in blue within each grade of the percentage of those held back. Roughly 40% with some minimal hearing back are held back a grade, versus very low single digits.
So impacting, certainly, to your education and development. Prior to Pedmark, it was not... there was nothing you could do to prevent this hearing loss. The best you could do was after you lost your hearing. I showed you some pictures earlier of hearing aids and cochlear ear implants, but this is devastating and life-impacting. So what do we do at Pedmark? Hopefully, it's pretty straightforward after listening to this. We are the only FDA and EMA-approved treatment for cisplatin-induced ototoxicity. We were successful in two-phase clinical trials. Shows a clear benefit with approximately a 50% reduction in hearing loss. The only commercial pharmaceutical company dedicated to CIO, and with no branded competitor in development. It's a rapid infusion time. It's approximately 15 minutes post the administration of cisplatin, six hours after the administration of cisplatin.
And in 2023, we were endorsed under NCCN AYA guidelines with a Category 2A, and I'll follow up, elaborate on that in a few slides. So this is a picture of the market, the traditional pediatric oncology market. As you can see, the U.S. market under our label, there is a potential of a little over 3,500 patients on an annual incidence. Similar in Europe, we have global rights to Pedmark, so the incidence is pretty parallel, depending on the population of different territories. In addition to the U.S. and Europe, we are running a study in Japan, which we hope to get to, the ability to go to registration in Japan. Other attractive markets include the Middle East, and China, and really to enable the opportunity for all patients to prevent this hearing loss when they're administered cisplatin.
This is the pediatric oncology landscape, really driven by high, key academic centers. 80% of all cisplatin use is with 200 institutions, and you can see there's approximately 500 total target pediatric hospitals across the U.S. With the NCCN endorsement Category 2A, we are quite excited about the opportunity to enable and provide the population of 15 to 39 the opportunity for Pedmark when using cisplatin. What this tells you here is there's a very high incidence rate when it occurs for testicular cancer. That's the most prevalent use. The population within this age group is approximately three times the size of the pediatric population, so roughly 10,000 patients that we hope to be able to provide an opportunity to utilize Pedmark and prevent the hearing loss.
As I mentioned, we received in June 2023 NCCN endorsement, and we see this as a significant opportunity in addition to the traditional pediatric opportunity. So what's our commercial strategy? We have approximately thirty employees in the company. 2/3 of those are customer-facing. So that includes our sales reps and our medical affairs team. But really, it's to establish Pedmark as the necessary complementary agent when prescribing cisplatin. So we are working to create education and awareness across the markets that I indicated earlier, for an understanding of Pedmark as the first and only FDA and EMA-approved agent. So we have traditional activities in place, as you would consider with most commercial organizations. Key to this are our relationships with KOLs, audiologists, patients and parents, nurses.
So we have education awareness through our marketing. We have commercial partnerships, which I'll highlight in a few slides later, and we make sure that our commercial and medical team is aligned to support the patients. We have a Fennec HEARS program with dedicated care coordinators available to answer insurance questions about coverage for Pedmark and provide resources for managing the patient's treatment. Here are some of the partnerships which are key to our success. Included amongst those are Momcology, a mom advocacy group, Testicular Cancer Awareness Foundation, the Coalition Against Childhood Cancer. Again, this is a full circle of partnerships, which starts with the KOLs and continues through nurses, patients, and parents. And lastly, here is our financial and capital structure. We're listed on the Nasdaq. You can see our ticker there, FENC, and on the TSX.
We have approximately 27 million shares outstanding, a market cap of roughly $130 million. We have cash and cash equivalents of $43 million. And for the first six months, we did approximately $15 million in net sales, so we're at about a $30 million net sales run rate. Our cash burn in 2023 was $16 million. Important to note there, we need, based on our current operating expenses of approximately $25 million a year, we need about $32 million-$35 million to be cash profitable, so we are very close. We have debt of $32 million. That's convertible debt. The strike price on that convertible debt is $8 per share, with a coupon of about 13% all in. You can see some of our investors there.
We have some large investors and supportive investors that have been with us for many years. The last slide is some additional safety information as it relates to Pedmark, and thank you all for your attention, and happy to take questions.
Does anyone have any questions?
Can you go back two slides? Sure.