Jaguar Health, Inc. (JAGX)
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Earnings Call: Q1 2023

May 15, 2023

Operator

Greetings, welcome to the Jaguar Health Investor Webcast. At this time, all participants are in listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Before I turn the call over to management, I'd like to remind you that management may make forward-looking statements relating to such matters as continued 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. 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 the currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company's 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 risk factors sections of the company's Form 10-K for the year 2022, which was filed March 24, 2023, and its other filings with the SEC, which are available on the investor relations section of Jaguar's website. Except as required by law, Jaguar undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future 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 the basis upon which company management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance in conformity with GAAP. Today's conference is being recorded. At this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health's Founder, President, and Chief Executive Officer. Lisa, the floor is yours.

Lisa Conte
Founder, President, and CEO, Jaguar Health

Thank you. Thank you for that very comprehensive forward-looking statements as well. Thank you all for joining our first quarter 2023 earnings webcast. Welcome to you all. As you just heard, my name is Lisa Conte, and I am the founder, president, and CEO of Jaguar Health. While this is an earnings webcast, our overreaching theme for this morning's discussion is patient voice and its importance in every aspect of drug development, including labeling and regulatory approval, raising awareness of non-infectious diarrhea, preparation for promotion related to the potential introduction of crofelemer for prophylaxis and mitigation of cancer therapy-related diarrhea, and commercialization to provide comfort and treatment to a meaningful share of the affected population.

We are prioritizing learning from and listening to patient voice to bridge from the HIV community to the cancer community, and to refer to crossing the chasm, to take a phrase from Geoffrey Moore, if anybody's familiar with that book. We can do better by co-creating awareness with the patient community through education around crofelemer's potential entry to the cancer market to provide a better solution to the comfort, the dignity, and treatment outcomes to cancer patients with chronic diarrhea. We believe this will allow us to best serve these important neglected comorbidities. The potential patient reach is much larger for the cancer community than the HIV community, both in terms of the number of patients affected by non-infectious diarrhea and of emerging relevance with the paradigm shift in cancer care to long-term targeted treatments that often result in chronic secretory diarrhea.

We have two short video interviews, one from an oncologist who is a thought leader in the field and one from a well-recognized patient advocate on this important issue, which we will play for you in a moment, and I think you will enjoy and find really important. First, however, I want to address our sales performance for the first quarter of 2023. We have to own this and learn from it. After five consecutive quarters of prescription product net sales growth, we have now seen in Q1 a decrease in prescription product sales compared to the prior quarter and compared to the first quarter of 2022. Let me say it again.

This is a learning moment for the organization and likely a wake-up call that we have perhaps lost sight of the depth, reach, and importance of patient voice to facilitate expansion of the care crofelemer can provide into the HIV community, the current approved indication. Over the past 18 months or so, as we shifted to a specialty pharmacy distribution model and incorporated other aspects of a patient access program, we've facilitated the difficult process of gaining prior authorization for patient reimbursement, and we improved gross to net revenues significantly by decreasing distribution costs and improving our payer mix. The population of adults living with HIV/AIDS is an aging population. According to the National Institutes of Health, nearly 50% of those living with HIV in the U.S. are age 50 and older and have had the virus in their gut for over 10 years.

A trend we have seen over the last 2 years is a decrease in net sales in the first quarter of the year over the prior quarter, due mainly to commercial and Medicare plan deductibles resetting, which results in a much higher out-of-pocket cost to patients during this time period, the first quarter. The Inflation Reduction Act has specific Medicare provisions that start to take effect in 2024 that will reduce prescription abandonment in the first quarter of the year due to significantly lowered out-of-pocket expenses for patients. We believe the provisions in this legislation should benefit the Mytesi brand and the Q4 to Q1 dip when implemented. We also believe that higher co-pays in Q1 account for about half of the decrease in net sales in the first quarter of this year over the Q4 2022.

To help address the additional shortfall, we at Jaguar are taking diagnostic steps to understand how the voice of the people in the HIV community needs to be incorporated further into our patient access activities. It appears we've lost our reach to some of the patients. The continued learning of how to effectively navigate the HIV market is foundational to our preparations for the potential introduction of crofelemer to the much larger U.S. oncology market for our target indication of prophylaxis of cancer therapy-related diarrhea. Much larger here, when I say much larger oncology market, is referring to the estimated 1.8 million patients newly diagnosed with cancer each year in the U.S. Additionally, annually in the U.S., there are an estimated 1 million cancer patients on targeted therapies chronically with an average rate of non-infectious diarrhea of 80%, the most common side effect.

An estimated 40% of patients have their therapeutic dose, their cancer therapeutic dose, reduced or go off their life-saving targeted therapy because of the side effect of diarrhea. With the now fully enrolled phase III OnTarget trial, we are addressing this paradigm shift of prophylactic treatment of cancer therapy-related diarrhea with crofelemer. I do want to say that again, fully enrolled OnTarget trial, which we're very excited about. This is analogous to what already occurs in the supportive care cancer world with chemotherapy-induced nausea and vomiting. It's referred to as CINV. Guidelines and protocols that incorporate prophylaxis for CINV, typically the first 3 days of cytotoxic chemotherapy. That global market is projected to reach $3.9 billion by 2029, according to a report from iHealthcareAnalyst, Inc. There's a good portion of that market that is addressed with generic products.

With targeted cancer therapy, we're talking about chronic diarrhea for several months to several years in both the metastatic and curative scenarios, nothing tested or approved specifically for cancer therapy-related diarrhea. Crofelemer would be the first entry to this market. We're going to play two short recent videos for you consisting of segments from interviews regarding the neglected comorbidity of cancer treatment-related diarrhea with two amazing women, both of whom are members of Jaguar's Scientific Advisory Board. Dr. Sandra Swain, who's a Professor of Medicine at Georgetown University and former President of ASCO, the American Society of Clinical Oncology. She served as the senior investigator of the investigator-initiated HALT-D trial, phase 2 trial, evaluating crofelemer for preventing chemotherapy-induced diarrhea in HER2 positive breast cancer patients, which was published last October in the peer-reviewed journal Breast Cancer Research and Treatment. The other video features Dr.

Kelly Shanahan, a metastatic breast cancer patient who's now a full-time independent patient advocate who made a shared decision with her oncologist regarding chronic targeted therapy specifically to avoid the side effect of chronic diarrhea. As she so eloquently says, so she could live, not just exist. Following the videos, Carol Lizak, Jaguar Health's Chief Financial Officer, who's having a little trouble connecting, so hopefully Carol Lizak, Jaguar Health's Chief Financial Officer, will provide a more detailed recap of key financial results for the first quarter of 2023, and we will review the clinical milestones we have coming up in 2023 this year that we feel will be transformative in terms of value inflection for the company. We'll now move forward with the two videos, and I'll turn it over to Peter. Hello? Thank you, Peter, for showing those videos. I hope everybody had an opportunity to see those.

It's impossible to overstate how inspirational and powerful these women are and all the advocates from the healthcare profession as well as patient advocacy in the cancer community, in part learned from patient advocacy in the HIV community and now back full circle from the cancer community back to the HIV community. We're so honored to have them on our scientific advisory board. As a company, we went to great lengths to incorporate this patient voice and to design a first of its kind patient-centric clinical trial for the investigation of the prophylactic use of crofelemer in cancer therapy-related diarrhea. This is the OnTarget trial, which has now completed enrollment, ensuring patient-reported outcomes as the primary endpoint.

In support of our goal of obtaining FDA approval for a paradigm-shifting first oral antidiarrheal drug for the management of CTD, OnTarget is the first trial of its kind to include participation of adult cancer patients with a diversity of solid tumor types. It's also the first clinical trial to include multiple targeted therapies that have more than 50% all grade diarrhea with or without standard chemotherapy. The first prophylactic trial of targeted therapy with concomitant and chronic crofelemer administration. Prophylactic chronic crofelemer administration. Our goal in reality is the enrollment of a diverse population of cancer patients. The trial includes clinical trial sites not only in the United States, but also Georgia, the country, Serbia, Argentina, and Taiwan. This phase III OnTarget trial is conducted with the same dose and formulation of crofelemer as our Mytesi product.

Crofelemer has a GMP supply chain in place from the rainforest to our distribution network of specialty pharmacies across the United States. As a reminder, safety and manufacturing are the two most common reasons that new drug applications fail. These activities are completed for crofelemer from a regulatory perspective with the commercial approved product we already have on the market, which is being utilized in the phase 3 clinical trial. A new near-term development goal for the company focuses on something called microvillous inclusion disease. I'll refer to it as MVID. This is an ultra-rare pediatric congenital diarrheal disorder, often referred to as CDD, congenital diarrheal disorder. MVID and short bowel syndrome with intestinal failure are our two prioritized rare disease investigative indications for a novel formulation of crofelemer. MVID is a catastrophic medical situation for pediatric patients, and there are currently no approved drug treatments.

We are planning to submit an investigational new drug application to the FDA for MVID in the second quarter of 2023. Literally right around the corner. We're in the second quarter of 2023. For the European market, MVID and other CDD patients could potentially participate in revenue-generating early access programs targeted for 2024. In accordance with the guidelines of specific European Union countries, publications of data from proof-of-concept trials could support participation in early patient access programs for crofelemer for these patients. Participation in early access programs which do not exist in the United States provides an opportunity for reimbursement while impacting the morbidity and the high cost of care for these chronic unmet needs.

To recap, in 2023, This year, we expect to have top-line results from our phase 3 trial for prophylaxis of cancer therapy-related diarrhea, our OnTarget trial, and the initial proof- of- concept evidence for patients with either short bowel syndrome with intestinal failure and/or for CDD, which may include MVID, in support of potential early access program participation in certain European countries with reimbursement. These programs are sufficiently resourced from Jaguar.

We are prioritizing for 2023 these late-stage clinical development programs, and we are prioritizing the learning and listening to patient voice to bridge the chasm from the HIV community, how we need to do better there, and prepare to co-create the education around crofelemer's potential entry to the cancer market to provide a better solution to support the comfort, the dignity, and the treatment outcomes, the cancer treatment outcomes of cancer patients with chronic diarrhea. Before I hand the discussion over to our CFO, Carol Lizak, who was able to connect, I'd like to tell all of you participating today that we're gonna have a brief Q&A segment at the end of the webcast to address if there's any questions submitted in writing. Ian Wendt, Jaguar's Chief Commercial Officer, is also on today's call, as well as Dr. Pravin Chaturvedi, Jaguar's.

Chair of the Scientific Advisory Board and Chief Scientific Officer, and they can respond to any submitted questions that may be relevant for their functions. 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 Health website. The URL for Jaguar's website is jaguar.health. We'll now move along to the key financial results for the first quarter of 2023. Carol, are you on?

Carol Lizak
CFO, Jaguar Health

Yes, I am. Thank you, Lisa.

Lisa Conte
Founder, President, and CEO, Jaguar Health

Okay.

Carol Lizak
CFO, Jaguar Health

Thank you all.

Lisa Conte
Founder, President, and CEO, Jaguar Health

Thanks, Carol.

Carol Lizak
CFO, Jaguar Health

Yes. Thank you all for joining our webcast today. I'll begin my review of our financials for the first quarter of 2023. Prescription product net revenue was approximately $2 million in the first quarter of 2023, representing a decrease of 40% compared to prescription product net revenue in the fourth quarter of 2022, which totaled approximately $3.3 million, and a decrease of approximately 25% over prescription product net revenue in the first quarter of 2022, which totaled $2.6 million. Mytesi prescription volume decreased approximately 9% in the first quarter of 2023 compared to the fourth quarter of 2022, and decreased 1% in the first quarter of 2023 compared to the first quarter of 2022.

Prescription volume differs from invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels. Loss from operations decreased by $2 million from $11.8 million in the quarter ended March 31, 2022, to about $9.8 million during the same period in 2023. Non-GAAP recurring EBITDA for the first quarter of 2023 and the first quarter of 2022 were a net loss of $9 million and $9.4 million, respectively. Finally, net loss attributable to common shareholders decreased by approximately $6 million from $18 million in the quarter ended March 31, 2022, to $12 million in the same period in 2023. That concludes my recap of high-level financials for the first quarter of 2023. I will now hand the discussion back to Lisa Conte. Thank you.

Lisa Conte
Founder, President, and CEO, Jaguar Health

Thanks, Carol. Okay. We at Jaguar, Napo Therapeutics, we're energized about all the important initiatives underway in 2023 and beyond. As you can see from the numbers, working very efficiently with these very important near-term late-stage clinical activities. The company's current cash position, the last reported cash at the end of the first quarter is approximately $14.3 million. The current cash position also includes gross proceeds from a PIPE transaction concluded in the second quarter of approximately $1.86 million, involving the issuance and sale of approximately 3.4 million shares of unregistered Jaguar common stock and approximately 6.85 million warrants not exercisable until January 1st, 2024. This financing involved a small group of dedicated long-term Jaguar investors.

Pursuant to the terms of the PIPE purchase agreement, each participating investor agreed not to sell or transfer any Jaguar equity securities for a period commencing on the signing of the agreement, which was very recent, last week, and ending 6 months after the PIPE closing. There is no anti-dilution, no resets, no variable pricing rights, nothing toxic associated with the securities issued in this PIPE. We believe this financing illustrates the confidence that the participating and well-educated investors have in the company and the expectation that both the OnTarget trial and our focus on development of proof-of-concept data for crofelemer for the rare disease indications previously discussed will prove transformational in 2023 for Jaguar value inflection and recognition. We'll now open the floor for written questions that have come in. I'll repeat the questions. Okay. Question. Well, here's a very detailed question.

How many shares are currently outstanding? How much cash is on the balance sheet? What is the monthly net burn? Just to recap some of the numbers that we just went through, the last reported cash at the end of the first quarter is approximately $14.3 million. Last part of this question. What is the expected date of a readout from the OnTarget trial? Last reported cash, $14.3 million. The PIPE, which closed in the second quarter, approximately $1.9 million. If you look at the first quarter average monthly burn is about $3 million per month, and that's pretty heavily into phase 3 clinical trial operations. The expected reported date for top-line results from the OnTarget trial is in October of this year.

We're talking probably a little less than six months away. We're confident, as I said, about our resource stability to get there, and we have about 19 million shares outstanding right now. I have another question about the Chewy deal that we just announced. I didn't talk in my comments about, but just to be efficient, we have a small business, a very important business in animal health. We have a conditionally approved product for chemotherapy-induced diarrhea in dogs called Canalevia. Conditional approval is how you work with the Center for Veterinary Medicine of the FDA to get a product out there for an important unmet medical need.

Ian, if you are on the line, would you mind speaking a little bit about how Chewy can expand the opportunity for pet parents to be able to get access to Canalevia?

Ian Wendt
CCO, Jaguar Health

Yes, sure. Happy to. Thank you, Lisa. Yeah, Chewy, you know, is a major retailer, including, you know, a lot of different pet-related products, but including prescription products and supplements. This just gives another very convenient option for oncologists or any vet who would prescribe Canalevia-CA1 to be able to utilize their services. It makes it more convenient for the vet, but also more convenient for the pet owner. If the vet doesn't have stock on hand of Canalevia, they can e-prescribe to Chewy very easily, or even the pet owner can initiate the prescription, and Chewy will reach out to their vets to fulfill the prescription.

It just gives additional options, a different additional channels of distribution, just to make the lives more convenient, as I said, of the pet owners and the vet. We're really happy with this relationship that we have with Chewy. We're already getting good feedback from both pet owners and vets about this. You know, at the end of the day, it makes the product more broadly available and more easily available for all the stakeholders that we believe are so important.

Lisa Conte
Founder, President, and CEO, Jaguar Health

Thank you, Ian. You know what? While you're talking, there's a question here about the first quarter impact that many companies deal with on the donut hole. Could you talk a little bit about the, you know, what that's like in the U.S. reimbursement healthcare system, particularly with Medicare and government-paid programs, and how that is likely to change in 2024?

Ian Wendt
CCO, Jaguar Health

Yeah. Happy to. Every Q1 for Mytesi, and this is common among most prescription brands, there are some challenges that are seasonal and a little bit unique to Q1 each year. The main reason that occurs, it really impacts mostly commercially insured patients and Medicare Part D patients. As many on the line here may have experienced, you know, your deductibles reset in the new year, sometimes plan changes occur with your employer during the new year and can cause a little bit of disruption.

For those individuals that are on a chronic medication and through the end of Q4, so the, you know, preceding quarter, they may have met their deductibles and what the result there is often that their co-pays are very low or maybe zero for their medications at that time. There's very few cost barriers to fulfilling and getting your medication. In Q1, all of that resets, and we all have to meet our deductibles again, which can present challenges for patients. On the commercially insured side, we have a great co-pay program in place to really assist those patients. It's a very generous program, and very few patients have significant out-of-pocket if they take advantage of that program.

We really work hard to make sure that all those commercially insured patients know the program exists so they can take advantage of it. Most commercially insured patients are gonna pay $0 in out-of-pocket, even in Q1, although there are some exceptions with some patients that have catastrophic insurance plans and things like that. The bigger challenge is with the Medicare Part D patients. Federal law prohibits us from offsetting the out-of-pocket costs for those patients. This is true for every branded product. Manufacturers would love to help those patients, but we're just not allowed to do that. For those patients, this is a pretty big impact. This is something that occurs every year. As I said, it disproportionately impacts the Medicare Part D patients.

We see a dip in prescription refills for those patients in Q1, and over 50% of our patients are Medicare Part D. When they meet their deductibles, usually around the February-March timeframe, we see the prescriptions pick back up again because their deductibles are now lower or more manageable. The other positive news here, though, is the Inflation Reduction Act has some provisions in it specific to Medicare Part D. There's a lot of complexity in there, but the main thing that we focus on and that we're excited about is that starting in 2024 and then really ramping up in 2025, there's gonna be a cap to out-of-pocket co-pays for Medicare Part D patients.

In 2024, the cap will be about $3,250. In 2025, it'll cap out at $2,000. This is good news for all of our Mytesi patients, current and future Mytesi patients, 'cause we think about CTD and our potential future indication there. About 65% of those patients are Medicare Part D. The timing couldn't be better from our perspective, in having this legislation take effect right around the time we'll be launching into that therapeutic area.

Lisa Conte
Founder, President, and CEO, Jaguar Health

Thank you, Ian. We all learned something about Medicare today. Pravin, are you on the line?

Pravin Chaturvedi
CSO, Jaguar Health

Yes, I am.

Lisa Conte
Founder, President, and CEO, Jaguar Health

Okay. There is a question we had mentioned at some point in the past about COVID-related diarrhea, long-hauler diarrhea. That is a program that we are not going forward with. It's still not defined well enough for us to, you know, be sure we have a mechanistic match. Also, as I mentioned, we are focused very much for this year. Let's be realistic about the financial environment in general and specifically about small cap, medium cap biotech companies on those events that we feel can be transformative this year, late-stage clinical events that lead to near-term revenue generation. Pravin, perhaps you could talk a bit about the inefficiently the mechanistic rationale for crofelemer for cancer therapy-related diarrhea and how that links to mechanistic rationale that for the current approved indication in HIV-related diarrhea.

Pravin Chaturvedi
CSO, Jaguar Health

Oh, absolutely. Happy to. Thanks, Lisa. The thing that crofelemer does mechanistically is it regulates the secretory function of ion channels. Ion channels, in general, are responsible for brain activity, heart activity, gut activity. Those of us who experience epilepsy or have family members or friends who have that, they have to have an exact balance of ion channel regulation because it's a constitutive function in the body that's necessary for normal homeostasis and function of the body. Just like the heart or the brain, you don't wanna have a full stoppage of either of those organs because that would be very detrimental.

crofelemer does the same thing for the CFTR chloride channels, which exist in the gut, and it regulates it and slows it down to the appropriate level so that we have formed stools. Diarrhea is like a manifestation, like epilepsy is, of ion channel firing. In HIV patients, the diarrhea results from two factors. one is, they have gut inflammation. HIV basically goes and inflames the gut and changes the cytokine levels that leads to dysregulation of the chloride ion channel. The second factor is the type of antiretroviral therapy that they get. You know, the approved package insert for all the drugs nowadays only lists grade three and grade four diarrhea and other AEs, adverse events.

When we think about what is grade one and grade two, and just like you heard from Dr. Swain's video, grade one diarrhea is three watery stools every day. Imagine having that every day for the rest of your life. While it's not considered bad, it is absolutely impactful on the activities of daily living. That's because of the inflammation that's caused by HIV as well as a combination of the drugs. In cancer therapy-related diarrhea, you get the same inflammation in the gut because cancer is a reflection of inflammation. It's a disease of inflammation and aging. You have dysregulation of your cytokines, and therefore you also have, from cancer, you have diarrhea.

If you get targeted therapies, some of them actually are more impactful in the EGFR, epidermal growth factor regulation, which has a direct effect on another channel that crofelemer also affects. Same way it dysregulates, it causes secretory diarrhea. Exactly analogous to the HIV indication is the cancer therapy-related indication. Crofelemer has been around for centuries. The shamans were using it in a different form. We were able to draw the analogy and work with the FDA and our clinical advisors and scientific board members to effectively design a trial that leverages the approved package insert and go after the second chronic non-infectious diarrhea indication in cancer patients. It's a very high and neglected comorbidity in cancer patients that really tethers them to a toilet and impacts them.

We have a lot of interest in this trial as well, and we're very excited that we've finished our enrollment, and are moving towards the filing with the FDA later this year. Back to you, Lisa.

Lisa Conte
Founder, President, and CEO, Jaguar Health

Thank you. Okay, here's a related question that I'm going to let you comment on from the medical perspective, Pravin. How do you feel When we finish the trial, and if we're able to get crofelemer or Mytesi introduced to the cancer therapy-related diarrhea market, how would that impact the ability to utilize cancer therapies in their patients for them, for their adherence?

Pravin Chaturvedi
CSO, Jaguar Health

It will only make it better, because the way as you heard from Dr. Swain's video and from Dr. Shanahan's video, the way currently oncologists manage the AEs, particularly related to GI and lower bowel movement, which is diarrhea, is by actually reducing the dose of the cancer therapies. What they do is they either give a drug holiday, and we used to do that for HIV drugs as well back in the 1990s and early 2000s and/or discontinue or switch their regimen. Since cancer is like running a marathon, you gotta have the right shoes on and basically have enough runway to go through one regimen and then to another.

You might be progression free, or you may be in remission for a few years, and if you're lucky, for several years. When the cancer comes back, you need to go to a new regimen. In terms of using your regimens well and at the right dose, by not having so much diarrhea, as I said, even grade one is three watery stools every day, you are able to stay on your regimen and not have to suffer dose reductions and/or dose discontinuations. We're gonna analyze that data as well in the ongoing phase three study. We will have more information on that. Hope that answers the question.

Lisa Conte
Founder, President, and CEO, Jaguar Health

It does. I hope this answers the question that was posed here about we're focused on the impact to the patient care, all aspects of it, including, as you just heard from Pravin, the outcome on the cancer outcome for these patients. The question was about the revenue impact for these cancer therapeutic manufacturers and therefore the potential business opportunity with Jaguar. Where there is a positive financial impact to the pharma industry, yes, there is absolutely an opportunity for business discussions. As I said publicly many times, those discussions are ongoing right now. We would expect that with the top-line data released from the OnTarget trial expected in mid-October of this year, there would be that would further those business conversations. There is a question about the Entheogen Therapeutics Initiative program that we have.

That is a program, an early-stage program within Jaguar that is focused on psychoactive and psychedelic plans for the novel treatment of mental health disorders, mood disorders, following in a movement now, psilocybin, MDMA, LSD, a lot of these psychoactive and psychedelic products to look at new ways of treating and potentially curing mental health disorders. Most of the companies, and that are well, very well-financed, a lot of resources, are chasing after these seven same compounds, and products and approaches. We're looking at the next generation. What can we do like we did with crofelemer? Finding new mechanisms of action, focusing on plant-based botanical products that have some more efficient opportunities to get into clinical trials quickly. The way that we're pursuing that is in a joint venture with a company called Filament Health.

The joint venture, which is funded with outside dollars, is called Magdalena Biosciences, named after the beautiful river flowing through the country of Colombia. The initial therapeutic focus is on adult ADHD. We do have several plants that have been prioritized based on the symptomatology that has been seen in the field, working with healers, working with shamans, bringing our expertise on botanical drug development, natural products, sustainable supply, novel mechanisms of action. Everything that we did successfully with crofelemer is what we're bringing to bear to Magdalena. Magdalena has a post-money valuation from its venture funding of $5 million. We own approximately 40% of that joint venture.

The goal here is to bring the first plant-based product, likely in ADHD, might be in depression or schizophrenia, bring it into clinical development and then bring on a partner that is really focused with the resources and the expertise on the regulatory and the clinical activities to take it all the way through to market. We're well on our way on that business plan. An earlier stage activity, leveraging a resource and an asset that we already had developed in the company, established in the company over 34 years. Taking very, very little effort currently on the part of the company. As I said, we're very well-resourced to focus on our 2023 late-stage clinical activities, but bringing more value and more diversity into the company.

The last question that I'll conclude with, there was a question about ATM and the announcement that we made on ATM utilization. ATM is an at-the-market facility. It is probably one of the most, according to investment bankers these days, the most efficient and least costly way to raise money for the company. We have agreed with the investment that we just did, the price investment that we just did, not to utilize the ATM. Not to put additional shares into the market without certain extraordinary circumstances.

As I said, if we look at our last cash position, the funds that we brought in from the PIPE, the historical burn rate, the target that we have, certainly for the OnTarget trial of top-line results in mid-October, we feel that we are resourced to get to that as well as likely the proof- of- concept and proof- of- concept data for MVID, the rare disease initiative. With that, I will conclude. Thank you very much for your participation. Thank you all from Jaguar who participated on this call. I do wanna say that it was International Day of Plant Health, as proclaimed by the Food and Agriculture Organization in the United Nations. It was last Friday. I do want to take this moment to express our deep dedication as a company to protecting and celebrating all of the world's plant life.

Healthy plants constitute the foundation of all life on Earth, as well as core ecosystem function, food security, and nutrition. According to the U.S. Forest Service, a full 40% of the drugs behind the pharmacist counter in the Western world are derived from plants that people have used for centuries, including the top 20 best-selling prescription drugs in the U.S. today. We at Jaguar understand that plants are precious and irreplaceable resource, and that humanity's health is inextricably linked to their health. That concludes our webcast for today. Thank you again for joining.

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