Jaguar Health, Inc. (JAGX) Earnings Call Transcript & Summary

Before I turn the call over to management, I'd like to remind you that management may make forward-looking statements relating to the matters as contained growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends and product initiatives, including products in the development stage, which may not achieve scientific objectives or meet stringent regulatory requirements. Fast -- forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on currently available information and management's current assumptions, expectations and projections about future events. While management believes its assumptions, expectations and projections are reasonable in view of currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the forward-looking statements and the Risk Factors sections of the company's Form 10-K for the year 2021, which was filed March 11, 2022, and its other filings with the SEC, which are available on the Investor Relations section of Jaguar [indiscernible]. Expect as required by law, JAG undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, further events or otherwise. Additionally, please note that the company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects [indiscernible] basis upon the company management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or a substitute for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance and conformity with GAAP. Today's conference is being recorded. And at this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health Founder, President and Chief Executive Officer. Please, the floor is yours.

Thank you very much, and thank you for those comprehensive forward-looking statements. Welcome all. As you just heard, my name is Lisa Conte, and I am the founder, President and CEO of Jaguar Health and our wholly owned subsidiary in the United States, Napo Pharmaceuticals. And for those of you who can only participate for a short time here are the key takeaway messages from this webcast regarding upcoming potential momentum drivers. Combined net revenue for our prescription products increased in the third quarter of 2022 for the fifth quarter in a row, growing 8.2% in Q3 versus Q2 of 2022 and increasing approximately 412% over Q3 2021. Next, we expect the successful completion of our ongoing Phase III on-target clinical trial of crofelemer for cancer therapy-related diarrhea to potentially expand the indication of Mytesi, with enrollment in the trial targeted for completion in the second quarter of 2023, with an analogous market opportunity in chemotherapy-induced nausea vomiting of approximately $3 billion for comparison purposes. As we recently announced, the full results of the investigator-initiated HALT-D trial named HALT-D, evaluating crofelemer for preventing chemotherapy-induced diarrhea in breast cancer patients was published last month in the peer-reviewed journal breast cancer research and treatment, the principal investigator and author of that was Dr. Sandy Swain, who's the former President of ASCO. Next point, Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology division at the Sheikh Khalifa Medical City in Abu Dhabi in the UAE, is leading an investigator-initiated proof-of-concept trial of crofelemer for short bowl syndrome, which you may hear us refer to in this discussion as SBS and also congenital diarrheal disorders, which we may refer to as CDD. Publication of proof-of-concept data from this and other expected investigator-initiated trials could support early patient access to crofelemer for SBS and/or CDD with intestinal failure within 2023 through programs in Europe. These early patient access programs, which do not exist in the United States, are revenue generating and reimbursable for participating patients and focused on rare diseases where there are no good alternative treatments. Next, we expect that a business development deal will be executed in the next couple of months that will bring in non-dilutive funding in support of our mental health and Theragene therapeutics initiative program and our extensive proprietary library of plants and plant extracts, which is an asset we're looking to mobilize. And finally, a second conditional approval for Canalevia for exercise-induced diarrhea, which we refer to as EID in dogs is targeted for the first quarter of 2023, complementing Canalevia, which is currently conditionally approved for chemotherapy-induced diarrhea in dogs. And now I'll go into greater detail on these bullet point items. I'm going to begin today with the key top line results for the third quarter, the financial results for the third quarter of 2022. Prescription product net revenue totaled approximately $3.1 million. This is in the third quarter of 2022. And as I mentioned, this represents an 8.2% increase over the second quarter of 2022 and an increase of approximately 41% and over the third quarter of last year, 2021. And this is the fifth consecutive quarter of growth in Mytesi net revenue. We are quite pleased with the growth trajectory of our current prescription drug business. And as you'll hear, quite excited about the late-stage pipeline opportunities that we feel will be transformative in value recognition, value creation for all our stakeholders, including, of course, patients and our shareholders. I'll continue with a few other updates and then Carol Lizak, our Chief Financial Officer, will provide a recap of the key financial results for the third quarter of 2022. And after Carol speaks, we'll hear from Ian Wendt Jaguar's Chief Commercial Officer. Ian will speak to updates on Mytesi-related commercial initiatives to continue to educate and serve the HIV community and about ongoing commercial efforts underway for Canalevia CA1, our prescription product for the treatment of chemotherapy-induced diarrhea in dogs. We call that sometimes CID. And this product has been conditionally approved by the FDA and became commercially available just this year to veterinarians in April of 2022 and for dog owners to provide comfort and relief to their family members into the canine patients. As a reminder, our commercialized drug product is named Mytesi. The generic name is Crofelemer, -- it is a first-in-class antisecretory agent approved initially in the United States for the specialty indication of symptomatic relief of noninfectious diarrhea in adult patients with HIV AIDS on antiretroviral therapy [indiscernible]. As the term specialty implies, this is a relatively small market, an important market, but the HIV market is relatively small. The indication was fast-tracked by the FDA. And that's why it's the first approved indication for Crofelemer. As I frequently state, what is really powerful about proper is that it is a pipeline within a product. And what I'm going to focus on today are the 2 late-stage clinical milestones, what we believe are potentially transformative events in the next approximately 6 to 9 months in support of the company taking Crofelemer from pipeline opportunities to with the potential of important and significant clinical trial results, tangible revenue-generating patient benefiting product indications. The core human follow-on indications on which we're focused are cancer therapy-related diarrhea, CTD, in the United States. -- and through Napo's Therapeutics rare disease business model, a company that we established in Italy, the orphaned indications of SBS or Balasingam and CDD congenital diarrheal disorders, initially for commercialization in Europe. However, with clinical data, both generated in the U.S. and available for U.S. filings as well. So first, what exactly are these indications? Each year, according to the CDC, there's more than 1 million cancer patients in the United States receiving chemotherapy or radiation in an outpatient oncology clinic in the United States and as many as 50% to 100% of these patients experienced diarrhea depending on the treatment regimen. Most of us have had lives of our close community touching by cancer in some way. There have been amazing advances to treat survivors to make survivors, not managing diarrhea, negatively impacts patient outcomes of their cancer therapy as approximately 40% of cancer treatment patients who experience diarrhea, either discontinue their life-saving cancer therapy or move to or even start with a subtherapeutic dose of their cancer treatment regimen. This is at best, highly distressing and impacts the comfort and dignity of the patient and at its worst it impacts the outcome of the patient's chemotherapy and drives cost to the health care system from immense dehydration, potential infections, compromised outcomes for the cancer treatment. Enrollment is continuing for the on-target study that is the name of our pivotal Phase III trial of crofelemer for cancer therapeutic dated diarrhea in humans. We're aiming to complete this enrollment with a total of 256 patients by the second quarter of 2023, just around the corner. This is a prophylaxis study, which tells you a lot about how important it is to get in front of the impact of diarrhea during cancer treatment. CTD is not the mild loss of control that we've all invariably experienced with perhaps a minor flu or a bad meal. This is diarrhea that can put patients in the hospital can cause organ shutdown and has even contributed to death in some patients who have been in targeted cancer agent manufacturers clinical trials. With the new targeted therapies, cancer therapies that are used chronically, both in metastatic and in curative cancer situation, therapies are used for months or years. The incidence of diarrhea is sometimes as high as 100% to project the potential market opportunity for CTD since crofelemer would be the first drug to be approved for this indication, we're looking at an analogous market, chemotherapy-induced nausea and vomiting, CINV, how it's often referred to, which is projected to be close to a $3 billion global market this year according to a report published by Allied Market Research, and CINV agents are typically only used for about the first 3 to 5 days in traditional cytotoxic chemotherapy, and there are many generic entries in this market. With CTD, cancer therapy-related diarrhea, we're talking about diarrhea that can persist on a chronic basis for months or years. The enrollment criteria for our Phase III trial includes all patients with solid tumors -- so a basket approval, a broad approval, including a label for prophylaxis for patients on target therapy with or without cytotoxic chemotherapy in all solid tumors is the label expansion we are seeking for Mytesi. And let me point out, this trial is being done with the exact formulation of Mytesi, which is already proved, which obviously has a full GMP compliant supply chain in place and is approved for chronic indication. So has chronic safety completed as well. The 2 most common reasons safety manufacturing why new drug applications fail are already taken care of with Mytesi. We're very excited about this program with [indiscernible] strong safety profile, we expect cancer patients to be able to tolerate and benefit from Crofelemer chronically. The successful completion of enrollment in our on-target pivotal trial, again, just around the corner targeted for the second quarter of 2023. Well, we expect lead to a supplemental new drug application filing for Mytesi, as I mentioned, the same formulation of crofelemer that is currently approved. We spent much care and engaged in extensive communication with the FDA in the design and the execution of this final clinical and regulatory step to support bringing crofelemer to cancer patients suffering from diarrhea and/or the risk of diarrhea from their prescribed therapy. I'll now discuss our prioritized or bowl syndrome pipeline indication for crofelemer. I am Chairman of the Board of Napo Therapeutics, the corporation we established in Milan, Italy last year to which we granted an exclusive license to Crofelemer in Europe. Specifically, Napo Fera is initially pursuing a rare disease business model based on the orphan drug designation of crofelemer for SBS and CDD with intestinal failure, Jaguar is a majority shareholder of Napo Therapeutics as well as the licensor of the technology, which, therefore, provides equity interest value to Jaguar as well as typical license terms. Let me describe the catastrophic medical situation for people with SBS [indiscernible] syndrome. A normal gut is 20, 25 feet in length. In SBS, the patients could be less than 5 feet for congenital reasons or as a result of surgery due to cancer, inflammation or an accident. As you can imagine, with a very short gut, it's like a [indiscernible], what goes in comes right out. The bottom line is that there's not enough intestinal real estate surface area for the SBS patient to absorb the nutrients of life, carbohydrates, protein fats, vitamins and minerals. So what happens is that these patients often end up on parenteral nutrition, the intravenous feeding of liquid nutrients for up to 20 hours a day, 7 days a week. Obviously, a significant negative impact on the patient's quality of life, and there are multiple negative health impacts, infections, complications associated with parenteral nutrition. It's expensive. It costs hundreds of thousands to millions to $1 million a year to manage an individual patient, including not only the price of nutrition, but also the myriad of complications with very high morbidity and mortality. The global market for SBS is projected by third parties to reach $5 billion by 2027. This is a report from Vision Research reports. Although French nutrition is considered the standard of care, there is a drug product approved for SBS [indiscernible]teduglutide, very hard to pronounce teduglutide, which is a GLP-2 analog. It's essentially a growth hormone, intended to grow the surface, the real estate of the gut slightly so that there is a little bit more time for absorption. It's administered as an injection, and it's estimated to be utilized in less than 10% of the SBS patient population is not considered standard of care. And GLP-2 analogs have a range of side effects, including cardiovascular risk, endocrine risk, and it's not used chronically. The primary endpoint in the trial for the approval of teduglutide was the reduction in the time required to be on printer nutrition by about 20%. What we're looking to do with Crofelemer for a primary endpoint is to reduce the time on parenteral nutrition as well and provide better stool formation and a quality of life measurement, which the reimbursement organizations have indicated is important to them. As I mentioned, SBS development of crofelemer is being pursued through Napo Therapeutics in Europe, which holds an exclusive license to Crofelemer for the European marketplace from Jaguar. Jaguar is licensor, Napa Therapeutics as a licensee. And it's a classic license agreement, incorporating upfront payment milestones and royalties. We based the new company in Europe because key countries in the European Union and Europe, U.K., which is not the European Union, have early access programs for orphan indications with unmet medical needs like SBS, because of the impact on patients. Early patient access programs of this type do not exist currently in the United States. Hence, with published proof-of-concept data, patients in specific major markets in Europe and get access to a product through these early access programs, while the full approval trials are still being pursued. Early access programs are revenue generating and for participating patients, the product is reimbursed. We have approved an investigator-initiated proof of post-trial for feline 4 SBS in CDD. The third-party investigator is targeting a presentation of this trial at next month's December 2022 next month's World Congress of gastroenterology. This is a global GI conference in Dubai. Additional investigator-initiated requests and trials and clinical data are expected to come throughout 2023 from key opinion leaders with whom we've been in touch. And in accordance with the guidelines of specific EU countries, as I mentioned, publications of such data could support early patient access to crofelemer for SBS or CDD with intestinal failure within 2023. -- as Jaguar and Napo Therapeutics were pleased to announce last month the European Medicines Agency, which is the equivalent of the FDA in the United States, EMA is in Europe. The granted orphan drug designation for crofelemer for the indication of microvillus inclusion disease, MVID. This is a rare congenital disorder, so it's a form of CDD. And this -- it was granted in the European Union. This is a very welcome development for crofelemer because now it is a new molecular entity that has been granted to orphan designations by the EMA in less than 1 year. The orphan designation for SBS was received from the EMA in December of 2021. This regulatory progress for the molecule is absolutely remarkable. Crofelemer already holds orphan drug designation in the United States for SBS. And this is a classic rare disease estimated about 40,000 people around the world. Again, remember, third-party market research put the market opportunity at $5 billion for rare disease is about 40,000 given the way reimbursement works for rare disease business models. MVID, which, as I said, is a component of CDD is ultrarare with maybe only a couple of hundred of infants around the world. The orphan drug designation application for crofelemer for MVID was also submitted to the FDA in the United States, and we're standing by waiting for that designation. Financially important key advantage of Napo therapeutics effort to Jaguar is that Napo [indiscernible] is well over majority owned by Jaguar, providing potential equity value accretion to Jaguar shareholders and stakeholders value that we believe is unrecognized at this time. Jaguar also receives the value of any clinical data generated by Napothera and recyclicaly, Napothera receives the value and ability to utilize, for example, the CTD, the cancer Phase III data Jaguar is developing for their licensed territory in Europe. Hence, the parallel complementary and geographically focused development efforts of Crofelemer for these 3 core indications, CTD, SBS and CDD are progressing simultaneously and collaboratively with 2 dedicated focus and extremely experienced and talented teams for the relevant pursuits on each side of the ocean. So to recap, in approximately 6 to 9 months, we expect to have completion of enrollment in our Phase III trial of cancer therapy-related diarrhea, called the ON TARGET trial and published proof-of-concept data in support of potential early access program participation in mid-2023 in Europe for SBS and/or CDD, which could bring in meaningful revenues, while Crofelemer continues to go through the process for full approval in Europe, 2 expected transformative events on the near-term horizon, supporting value recognition, potentially moving initiatives from a pipeline opportunity to ultimately tangible revenues, further tangible revenues in hand for Crofelemer an additional key milestone for 2022 on the human front, for which we completed in the third quarter of this year was the filing of an investigational new drug application with the FDA for our NP300 drug candidate for the symptomatic relief of diarrhea from [indiscernible]. We were very pleased to hear from the FDA in September that they completed their review of our IND and concluded that Jaguar may proceed with its proposed Phase I clinical trial for the drug. And we are grateful for the partial financial support we received from the National Institute of Allergy and Infectious Diseases to support the NP300 preclinical program. Following the completion of Phase I trial, we are positioned to initiate the next stage of clinical development program for [indiscernible] -- when Jaguar has the requisite resources and bandwidth to initiate these additional trials. We intend to pursue a tropical disease priority review voucher to develop NP300 for the [indiscernible] indication under the FDA's financial incentive program. Priority review vouchers are transferable. And in past transactions by other companies, has sold for values ranging from $67 million to $350 million, which provides for a potential immediate return on investment upon approval of NP300 for the color-related diarrhea indication and receipt of a priority review voucher. And now if we move on to our Animal Health side of the business, which is a relatively small side of our business, but very important and meaningful. Crofelemer is also the active ingredient in Canalevia CA1, our product for chemotherapy-induced diarrhea in dogs for which commercial launch activities have already been initiated and ongoing throughout 2022. The entire cancer situation does is remarkably analogous to the human situation. And as with humans, it's estimated that dogs discontinue their disease-modifying chemotherapy or move to a subtherapeutic dose nearly 40% of the times due to diarrhea, meaning that these dogs cannot complete their therapeutic dose of chemotherapy because of diarrhea. The comfort of the dog is one of the most important, if not the most important considerations of dog owners when they decide whether or not to put their dog -- through cancer treatment. As you can imagine, you can't speak to the dog and also the entire household when is compromised when the dog has lost control. There are a couple of really important factors in the dog market. The incidence of cancer in dogs is reported to be 5x what we see in humans. And the total number of dogs in the U.S. is about $108 million post pandemic, $108 million. And unfortunately, and heart-breakingly, about 50% of the dogs over the age of 10 are going to be diagnosed with cancer at some point. So in addition to this really important conditionally approved indication of CID chemotherapy-induced diarrhea in dogs. Crofelemer is expected to be conditionally approved for the treatment of exercise-induced diarrhea in dogs in the first quarter of 2023. Jaguar also is proud to say that we launched the first ever canine cancer registry in the United States in May of this year. At an event in New York, we couldn't believe that of registry did not exist in the United States. The project is called the Jaguar Health take charge as an acronym initiative. The goal in establishing take charge is to assess the prevalence and insulin incidence of cancer in dogs and most importantly, how you can keep the dog and the entire family situation comfortable during what is often a very siloed and tragic event for family and help create a community of support and education with the information that comes from the registry. The take charge campaign was developed by [indiscernible], which is Jaguar's amazing PR firm and one of the financial cosponsors of take charge. And [indiscernible] efforts have led to more than 80 million media impressions generated for the for take charge with more to come, of course. And I'm happy to report that just this month, the Marcom Awards program, which celebrates excellence in marketing and communication honored take charge with 2 platinum or awards and 1 gold award, which drives awareness and therefore, the value of the registry, and we're quite proud of [indiscernible] runs capabilities and efforts there. In the next 12 months, there is the potential for a lot of other news. And in particular, on the business development front, we have global rights to crofelemer for all indications. For what I'm going to focus on, though, beyond our GI efforts is Jaguar's mental health focus development efforts, which is called Entheogen Therapeutics Initiative, ETI. And this initiative aims to discover and develop groundbreaking novel natural medicines derived from the psychedelic and psychoactive plants for the potential treatment and potentially cure of mental health disorders. This effort has been designed to mobilize a key Jaguar asset, our proprietary library of 2,300 plants and 3,500 plant extracts that was generated over 3 decades. In June of this year, Jaguar and Filament Health find a letter of intent to enter a collaboration agreement to develop botanical prescription drugs for specific psychoactive target indications in the United States. Filament has laboratories, manufacturing, manufacturing IP capability for natural and plant priced products that Jaguar as a company now focused on later-stage clinical development no longer has. We bring to the table the ethnobotany expertise of how to do drug development under FDA botanical guidance, which is the approval that we have for Mytesi. And our 2 companies together are seeking partnerships with well-funded entities to pursue regulatory approval and ultimately, commercialization for novel pharmaceutical prescription grade plant-based standardized drug candidates in the mental health space. Jaguar in filament together are far along in discussions. And within the next several months, I believe you can expect to see a formalized business development collaboration that involves bringing in nondilutive funding to help mobilize and leverage Jaguar's plant library for the very important initial targets, we're thinking of ADHD and social anxiety disorder, 2 markets that have understandably expanded because of the pandemic. I believe you can also expect to see other business development deals on the horizon because we are committed. It is our mission to bring crofelemer to all patient populations in need in all geographies around the world. Finally, I'd like to let all of you participating today know that we will have a brief Q&A segment at the end of the webcast to address any questions if they are submitted in writing. Questions can be submitted via the webcast link for today's event that appears on the Events and Presentations page of the Investor Relations section of Jaguar's website and the URL for Jaguar's website is jaguar.health. We'll now move along to the key financial results for the third quarter of 2022. Carol, our CFO, I'll turn it over to you.

Thank you, Lisa, and thank you all for joining our webcast today. I'll begin my review of our financials for the third quarter of 2022. The prescription product net revenue during the third quarter of 2022 was approximately $3.1 million and $2.9 million in the second quarter of 2022, an increase of about $200,000 or 8.2% quarter-over-quarter and an increase of approximately 412% over prescription product debt revenues in the third quarter of 2021. Mytesi prescription volume increased approximately 3% in the third quarter of 2022 over the third quarter of 2022. Prescription volume differs from invoice sales volume, which reflects, among other factors, varying product buying patterns among specialty pharmacies in the closed network as they manage their inventory levels. For the third quarter of 2022, the loss from operations increased by $400,000 from $9.5 million in the third quarter ended September 30, 2021 to $9.9 million during the same period in 2022. Non-GAAP EBITDA for the third quarter of 2022 and the third quarter of 2021 were a net loss of $8.5 million each, respectively. For third quarter of 2022, the net loss attributable to common shareholders increased by approximately $300,000 from $12.2 million in the quarter ended September 30, 2021 to $12.5 million in the same period in 2022. In addition to the loss from operations, interest expense increased by $600,000 from $2.1 million in the quarter ended September 30, 2021, to $2.7 million for the same period in 2022, primarily due to interest from the royalty and note agreements. Another one is the change in fair value of financial instruments and hybrid instruments designated at fair value option or FVO increased by $700,000 from a loss of approximately $600,000 in the 3 months ended September 30, 2021, to a gain of about $200,000 for the same period in 2022, primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO. Other expenses also increased by about $100,000 from $20,000 in this quarter ended September 30, 2021 to approximately $200,000 for the same period in 2022, and that's largely due to foreign currency transactions. That concludes my recap of high-level financials for the third quarter of 2022. I will now hand the discussion over to Ian Wendt, Jaguar's Chief Commercial Officer.

Thank you, Carol, and good morning to all. As Carol stated, my test total prescription volume, a metric we believe to be the best indicator of patient demand increased approximately 3% in the third quarter of 2022 over the second quarter of 2022. As previously announced, the transition we completed throughout the end of 2021 and into the beginning of 2022 to a limited distribution network of specialty pharmacies resulted in a meaningful reduction in Mytesi distribution costs as well as a higher average net price. I'm very pleased to report that we significantly outperformed the industry gross to net average in the third quarter of 2022 as we did in the previous -- in the 3 previous quarters as well for sales of our human prescription products. This improvement in our gross to net was largely a result of the efficiencies realized by the transition to a closed network of specialty pharmacies. This transition assists in the preparation of the company's U.S. commercial distribution network for potential future indication expansion of Crofelemer to other populations of patients with complex medical needs, such as CTD, inflammatory bowel disease, SBS and CDD. As Lisa mentioned, Q3 2022 is the fifth consecutive quarter of growth in Mytesi net revenue, which we're also very pleased about. I'm also pleased to report that our innovative recently launched programs that further support patients connecting to care and medication access services are continuing as planned. The first program is our telehealth initiative, which went live in May. This enables patients seeking help with their HIV-related diarrhea to be linked immediately to a provider for assistance with their medical needs. This new capability prevents patients from having to wait until their next scheduled doctor visit to get help with what is a really urgent problem. Our second recently launched program delivers digital Mytesi and disease state education directly into a provider's EHR, that's the electronic health record system. -- so that the provider can learn about Mytesi at the moment they are seeing their HIV patients. This technology allows us to intelligently deliver ads to a provider based on the profile of the patients they are seeing in their exam role. This is strictly a one-way communication. We do not receive any protected health information. Turning to the Animal Health side of our business. Canalevia CA1, our FDA conditionally approved drug for the treatment of chemotherapy-induced diarrhea, or CID and dogs became commercially available to veterinarians across the United States at the end of April 2022, as Lisa mentioned. Since that time, we have succeeded in pushing Canalevia CA1 into broad distribution with the leading veterinary distribution centers. Approximately 40% of the 280 veterinary specialty clinics in the U.S. have already ordered at least 1 bottle of Canalevia C1 -- this is a great indicator that veterinarians are seeing the clinical benefits of our product among their patients. Commercial launch activities for the drug remain underway and reception of Canalevia C-1 among general practice vets and veterinary oncologists continues to be extremely positive. For example, under our Jaguar Animal Health trade name for the veterinary market, we sponsored the October 26, 2022 episode of DBM360 live. This is a web-based magazine-style talk show veterinary professionals hosted by veterinarian, Dr. Adam Prissman, which drives awareness of [indiscernible] C1 and encourages veterinary clinics to contribute Canine cancer records to Jaguar's -- take Charge Canine Cancer Registry initiative -- veterinary oncologists, Dr. Sue Ettinger, who is also known as Dr. Sue Cancer vet appeared on the DBM360 live episode to discuss [indiscernible]. She was joined on the show by one of our canine patients, a Labrador mix undergoing chemotherapy for sarcoma and the dog's owner, who discussed his pets experience with [indiscernible]. Additionally, Jaguar Animal Health launched an on-demand webinar for veterinarians on October 27, 2022, titled chemotherapy-induced diarrhea in dogs effectively treating this therapy limiting side effect. U.S. veterinarians who participate in the webinar, which is hosted by veterinary oncologists, Dr. Craig Clifford, are eligible to receive 1 hour of American Association of Veterinary State Boards [indiscernible], which stands for registry of approved continuing education. This gives them an improved continuing education credit. This effort represents another way that we are actively engaging with providers one-on-one. And I'm excited to report that attendance for the live for the webcast, both the 2022 record for clinicians [indiscernible] who hosted DC training. -- the continuing education provider that hosted the event. We had well over 500 participants and there were a lot of excellent questions, all of which shows a great level of interest among veterinarians about managing and treating chemotherapy-induced diarrhea in dogs. As Lisa mentioned, we expect Canalevia C1 could additionally receive FDA conditional approval under the name candy in the treatment of exercise-induced diarrhea or EID and dogs in the first quarter of 2023. That concludes my comments. Thank you all for your time today, and I'll pass the conversation back to Lisa.

Great Apologies, okay. Hopefully, I did go off news here. And thank you, Ian and Carol. And we are all energized about all these important initiatives underway, proud of what we achieved in 2022, very excited about what's coming up and really just around the quarter in pharmaceutical industry terms, 6 to 9 months in 2023.

So a few questions have come in, and I will take a look at those. Okay.

One question is the current ATM at the market that is in use. How much is left to sell?

So let me tell you something about a company like us having the gift of qualifying and having an ATM in place. We have about $10.7 million -- approximately $11 million in cash reported at the end of the Q. And to be sure that we have sufficient funds to get to the end of, for example, our cancer trial, there may be a need to bring in more funds. And right now, if you look at the financing for companies that are in our range and our market cap, they're terrible. They're structured, their warrants. They really are highly toxic to current investors. And so with the ATM gives us the opportunity to do is bring in cash at the market, no warrants, no bells or whistles down the wheel world when necessary. So we're pleased that we qualify for one, and we do have about $50 million capacity on the ATM. That doesn't mean we're using $50 million of the ATM, but we do have capacity for $50 million on our ATM.

What are the key catalysts you were focused on in the upcoming year? Which of these catalysts do you think are most underappreciated by -- the Street? How do you think the macro environment may affect your business?

Okay. I think so much is underappreciated by -- the Street. I think just about everything is underappreciated by -- the Street when we have a market cap that is hovering around $20 million or so, right? This is a company that just reported the fifth straight growth in net revenue for and is in late-stage clinical development for this very same product, this very same formulation that's already approved and on the market for a blockbuster opportunity in terms of unmet medical need for the patients, the impact to move from simply supportive care, which is very important, the comfort of the patient but to also potentially have an impact on cost of treatment and outcome of the cancer patient. When we move to Napo [indiscernible], I think that is way under recognized and valued, not only is it an opportunity for meaningful revenue generation in 2023 from meaningful patient impact with short [indiscernible] syndrome, but there's also the equity piece of that. We own well over the majority of Napo Therapeutics, which has its own valuation, which can be recognized at the end of the year from the Italian filings. We have another product approval coming up, Canalevia CA-2 for exercise-induced diarrhea that would be our third prescription product approved. We have business development deals that could pop at any time. We did the Mid-East license in February of 2022. We obviously have the license in crofelemer in Europe, but we have other Asian countries available of the rest of world territories and a commitment to bring this product to all these different patient populations. So I'm not sure which one is under -- I'm not sure which one is valued. There seems to be nothing valued. So I think we're all underappreciated by -- the Street. And I think part of it is the macro environment and in particular, the macro environment for biotech and health care. So looking forward to events in all companies in our space to help bring greater recognition to this important industry.

Okay. When do you expect the trial to be completed, so you can pursue the vouchers. This is for cholera.

So cholera is we have, as I've mentioned, the next clinical trials in that -- for that indication are going to be timed for when we have resources to do so without unnecessary or very expensive dilution to our shareholders. So as we get some more events under our belt that are recognized by our shareholders, I think that would be the time to put some resources to the Calera program because it will be a couple of years before the completion and approval of that program, which is then what allows you to have the voucher. So we are very focused on near-term momentum drivers near term, 6 to 9 months or less to really bring value recognition to the undervalued situation at Jaguar now.

Are there plans for mergers and acquisitions in the not-too-distant future?

There are no specific plans for mergers or acquisitions. However, there are no terms in any deals that we have cut or anticipate to be cut that would prevent and merger or acquisition. And certainly, we wouldn't want that to occur at this horrendous valuation at the moment -- thank you. A nice compliment. Thank you for the compliment.

What was the third quarter revenue in dog-related therapy and project the third quarter revenues, specifically for the dog-related therapy?

Carol, I don't think we broke that out. Did we break that out in the Q?

Yes, it's on the 10-Q, yes, the Canalevia because we have human health and animal health. And do you know what that number revenue beyond looking at the moment.

And remember, this product was launched in the end of the second quarter, and that's when the loading occurs to the distributors.

About $150,000 for Canalevia.

And that is all the questions. So thank you all very much for listening. We look forward to 2023, and we will look forward to speaking to you again when RK results come out, and that will be in 2023 as well. Bye-bye. Happy next year.

Thank you. That will conclude today's conference call. Thank you for your participation.