Q3 2024 Jaguar Health Inc Earnings Call and Business Update
[music].
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 continuing 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 make achieved 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 complicated in such forward-looking statements. These statements are based on current available information and management's current assumptions, expectations, and projections about future events.
What management believes it is, its assumptions, expectations, and projections are reasonable in view of currently available information. Your caution 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 in sections in the company's Form 10-K in the year 2023.
which was filed on April 1st, 2024, and its other filings with the SEC, which are available on the Investor Relations section of Jaguar's website.
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 in a GAAP basis with provided non-GAAP EBITDA and non-GAAP recurring EBITDA.
Jaguar believes that the disclosure items in these non-GAAP measures provide investors with additional information that reflects the basis upon which the 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 or financial performance and conformality with GAAP.
Speaker Change: As a reminder, today's conference call is being recorded, and at this time it is my pleasure to turn the call over to Lisa Conte, Jaguar Health's President and Chief Executive Officer. Lisa, the floor is yours.
Lisa Conte: Thank you, Matt. Good morning, everybody. Thank you all for joining our Investor Webcast today.
Lisa Conte: As announced, this is an earnings webcast. And once again, I'm going to steal the thunder of our CFO, Carol Lizak, as we're pleased to report our net third quarter 2024 revenue of approximately $3.1 million increased approximately 14%.
versus the net in the second quarter of 2024,
Lisa Conte: and it increased approximately 11% versus net Q3 2023 last year's revenue of approximately $2.8 million.
So it's an earnings call. Those are the numbers.
Lisa Conte: I couldn't just stop right there, but I'm going to continue because as you hear, I'm going to address our ongoing commercial and development efforts. We have multiple near-term catalysts in the fourth quarter of this year. In the next two months,
Lisa Conte: and continuing early into 2025. And we view these as important and value enhancing catalysts for the recognition of the value in the company.
Lisa Conte: On the topic of key milestones, we are so pleased that we achieved significant results in the recently completed analysis from our recently completed Phase 3 on-target trial in the pre-specified subgroup of breast cancer patients.
Lisa Conte: This result has been accepted for a poster presentation, and it's on December 11th, 2024, so next month, at the very prestigious San Antonio Breast Cancer Symposium.
Lisa Conte: which is the largest international breast cancer symposium and also I believe the second largest cancer symposium in the United States after ASCO.
Lisa Conte: Patients with breast cancer accounted for the majority of the participants in the on-target trial.
which really is an unprecedented, global, prophylactic, prophylactic.
Clinical Trial.
Lisa Conte: for Diarrhea in Adult Patients with All Solid Tumors, receiving 24 different targeted therapies, with or without standard chemotherapy.
Lisa Conte: It's what we call a BASCA trial, attempting to address the treatment-related side effects of chronic diarrhea commonly suffered by all solid tumor patients.
Lisa Conte: This was an ambitious trial. We were putting a big inclusive hug around all patients that could potentially benefit all solid tumor patients.
Lisa Conte: And while the study did not achieve its primary endpoint for all solid tumor types included in the trial.
Lisa Conte: We did achieve meaningful clinical signals in breast cancer, as you just heard, and also lung cancer patients, two of the most common cancer diagnoses.
Lisa Conte: We are very, very happy, very pleased that this important abstract on breast cancer results has been accepted for San Antonio. And as announced,
Lisa Conte: A second late-breaking abstract related to the on-target trial based on data from the placebo arm of the trial has also been accepted for a poster presentation, and that too will occur on December 11th.
Lisa Conte: The value of the data in this poster is to shine a light with much greater precision on the rates and impact of cancer therapy-related diarrhea on patients beyond the summary and somewhat unsatisfactory descriptions of side effects, in particular diarrhea.
Lisa Conte: that appear in package inserts for many of the targeted cancer therapies.
Lisa Conte: And the impact in particular that this can have on the ability of patients to remain on their cancer therapy, to not have a reduction, an interruption, or a termination of their cancer therapy based on side effects, and of course, in particular, because of diarrhea.
My long-time colleague.
Lisa Conte: Dr. Pravin Chaturvedi, my brother from another mother, our Chief Scientific Officer and Chair of our Scientific Advisory Board.
Lisa Conte: And also, and separately, and also, are orphan-designated indications for prophylluma of microvillous inclusion disease, which is a congenital diarrheal disorder in pediatric patients when they're born, and short bowel syndrome for intestinal failure. This is
Crowe-Fellmer.
Lisa Conte: But it is a different product than Mitesi, which is the commercial, the brand name for the product that's currently on the market and the product for cancer therapy related diarrhea. This is a different formulation that is clinically, medically administration appropriate for these patients with intestinal failure.
Lisa Conte: And then after Pravin speaks, our CFO, Carol Lizak, she'll provide a recap in more detail of the financial highlights for the third quarter of 2024.
Lisa Conte: On our expanding commercialization front, which is very exciting, Jaguar launched the FDA-approved oral mucositis prescription product, GelClear, our third commercialized prescription product.
Speaker Change: We launched it in the United States about a month ago, a little less than a month ago, and it's another important milestone in support of our deep, deep commitment to supportive care and needs of people, and in particular, undergoing cancer treatment.
oral mucositis.
Speaker Change: is among the most common painful and debilitating cancer treatment related side effects and for those who don't specifically know what mucositis is
Speaker Change: I can give you actually a first hand assessment. I had an odd reaction two years ago to a COVID treatment and I ended up with grade four oral mucositis. It feels like broken glass in your mouth all day long.
Speaker Change: and with a habanero pepper on top of it. It is remarkably painful.
and what JailClear does, it's a joke.
Speaker Change: It has a mechanical action, and it's indicated for the management and relief of pain, the soothing of the pain by adhering to the mucosal surface of the mouth. It coats the mouth.
and protects, which soothes and supports healing.
It has oral mucositis, which
Commonly sometimes it's called chemo mouth.
Speaker Change: It has emerged as the most significant adverse event in oncology according to National Comprehensive Cancer Network.
Speaker Change: Up to 40% of all patients treated with chemo develop oral mucositis. And the same thing that I was mentioning about with our placebo results, it can impact the ability of the patient to stay on their cancer therapy, their life-saving therapy.
Speaker Change: When we talk about patients with head and neck cancers treated with chemotherapy and or radiation, experiencing severe oral mucositis, this impacts the patient's overall health and well-being.
Speaker Change: a patient's ability to swallow, to speak, to eat, to drink, and of course, again, can lead to their cancer treatment disruption and discontinuation. And it essentially, it's
Speaker Change: About 100%, almost every single patient that is dealing with head and neck radiation and bone marrow transplant.
Speaker Change: So, as we have launched, our core target audience are, in fact, the patients with head and neck cancer and the team that supports them, the oncology radiologists, nurses, nurse practitioners, dieticians, all the support groups.
Speaker Change: The National Cancer Institute estimates that about 71,000, more than 71,000 cases of cancer in the oral cavity, pharynx, and larynx will occur in the United States each year and in this year, 2024.
Speaker Change: One subset of the prescribers that has been quick to adopt and repeat gel clear prescriptions are nurse practitioners.
Speaker Change: Recognizing the importance that nurses play in the management of cancer patients overall treatment.
Speaker Change: We had the opportunity to meet with many of these providers at the American Academy of Nurse and Patient Navigators Conference just last week.
Speaker Change: Many of the nurses that we spoke with were familiar with GelClear and recognized the lasting and soothing benefits it provides to oral mucositis patients versus other treatments which don't last long, can sting, can burn, can cause numbing,
Speaker Change: and really are not satisfactory when put in the mouth. This is a wide open space for us to open with the benefits from Gelcler.
Speaker Change: We also met with many providers for this patient population at the American Society of Radiation Oncology Conference earlier in October.
Speaker Change: and heard strong, strong support for the availability of this as an alternative treatment as an option.
for their patients with oral mucositis.
Again, to relieve the patient.
Speaker Change: The pain, the quality of life and allow the patient to stay on their cancer therapy.
Speaker Change: Our other key area for near-term catalysts on the clinical development front, so now going back to the clinical development front, is cropheloma, as I mentioned, for rare and orphan diseases.
Speaker Change: MVID, microbulus inclusion disease, is this congenital diarrheal disorder, which is an ultra rare pediatric congenital diarrheal disorder and short bowel syndrome with intestinal failure, which will be referred to here shorthand SBSIF.
We have
Speaker Change: two phase two trials in the fourth quarter this year, the next two months. And we are supporting multiple investigator-initiated proof of concept studies for these two indications.
Including territories in the United States.
Europe, and the MENA regions, the UAE in particular.
Speaker Change: With results from the proof of concept studies expected potentially by the end of this year over the next two months and throughout the beginning of 2025. These are five different clinical efforts that I just mentioned initiating.
Speaker Change: essentially now, real time, that have been in the development for almost two years of regulatory filings, meeting with key opinion leaders, assessing the needs that are relevant to patients and providers,
Speaker Change: Designing Protocols, and they're all coming to fruition now and providing this opportunity for, again, what we feel will be value enhancing catalysts starting right now.
Speaker Change: We do have orphan drug designation for profilin in both the United States and Europe for both MVID and the SPS indications.
Speaker Change: In accordance with the guidelines of specific European countries, published data from clinical investigations proof-of-concept studies for both of these indications could support reimbursed early patient access to crofilamer for these debilitating conditions.
Speaker Change: Before there is full regulatory approval, early patient access programs that don't exist in the United States, and it's part of the reason why we have our subsidiary, NAPO Therapeutics, in Europe with a team that has the capability and the experience to move on this important strategy to get products to patients that need them.
Speaker Change: Rare diseases are really a very important business model and there are many companies that are built around only focusing on rare diseases. It's a
Program within Jaguar.
Speaker Change: It's important to recognize that prophyllum are, for these indications, relatively small population, high morbidity, high mortality, high expense.
Speaker Change: taking care of these patients, highly activated patient support groups. And it's a it's a different business model, different pricing. And as I mentioned, it is profilomer, yet it is a different product because of the different formulation.
Speaker Change: Before I hand the discussion over to Pravin, I'd like to let you all know that we will have a brief Q&A at the end of the webcast, and if there are any questions, we won't be able to, hopefully there are questions, and if there are questions, we may not be able to get to them all. They can be submitted in writing.
Speaker Change: and they can be submitted via the webcast link for the event right now that's on the events and presentations page of the investor relations section of Jaguar's website. The URL for the website is jaguar.health.
Speaker Change: Pravin, I'm now going to hand this over to you. Good morning, and we look forward to your update.
Speaker Change: Good morning, Lisa, and good morning all. Thank you for taking part in today's Investor Webcast.
Speaker Change: As Lisa stated, we are thrilled with the abstract of the results of the breast cancer subgroup responder analysis from the OnTarget Phase 3 trial have been accepted for presentation at the San Antonio Breast Cancer Symposium.
Speaker Change: Additional analyses of the on-target data are ongoing and these additional analysis may result in future submissions to other appropriate scientific forums.
Speaker Change: We plan to submit the breast cancer subgroup responder analysis to a peer-reviewed journal for publication in the future.
Furthermore, the content of the breast cancer subgroup responder analysis.
Speaker Change: We'll serve as the basis for preparing a briefing document that we plan to submit to the FDA for further discussion.
Speaker Change: We plan to request a meeting with the GI Division of the FDA in the first half of 2025 to discuss potential regulatory pathways for grafoma approval for the subgroup of, say, breast cancer patients.
Speaker Change: As a reminder, the Profelmo formulation that was studied in the on-target study is MITESI formulation, which is currently approved by the FDA for the HIV indication.
Speaker Change: Hence the safety and manufacturing sections of the new drug application have already been reviewed and approved by the GI Division of the FDA for profilamide-delayed-release tablets.
Speaker Change: The breast cancer subgroup results from the on-target study that are being presented at the San Antonio Breast Cancer Symposium are our responder analysis, which is also the analysis for the primary endpoint in the Pivotal Phase III Antenna Trial.
Speaker Change: That led to the FDA approval of grafelma for his current indication of symptomatic relief of non-infectious diarrhea in adult patients with HIV-AIDS on antiretroviral therapy.
Speaker Change: Profelma has consistently shown clinical benefit in other clinical studies based on responder analysis of gastrointestinal function.
Speaker Change: The results from two independent investigator-initiated trials for Crofilmer in functional diarrhea and chronic idiopathic diarrhea in irritable bowel syndrome patients based on responder analysis were recently presented last month.
Speaker Change: at the American College of Gastroenterology Annual Scientific Meeting in Philadelphia.
Speaker Change: We continue to evaluate Crofelma in patients with gastrointestinal unmet needs and observe, have observed Crofelma shows benefit in various patient populations that have secretory diarrhea.
Speaker Change: As Lisa mentioned, development of Crofilma has also been initiated for the orphan and rare disease indications of microbial inclusion disease, MBID, and short bowel syndrome with intestinal failure, SPSIF, which are a key focus for the company.
Speaker Change: We have focused on developing appropriate clinical study design, clinical endpoints that would meet regulatory requirements and also support clinical outcomes.
Speaker Change: By the end of 2024, in the EU, we expect to activate the Phase II trial in adult SBS IF patients.
Requiring total parenteral support, which includes total parenteral nutrition, TPN.
Speaker Change: Our Italian subsidiary, Napa Therapeutics SBA, has received the initial regulatory clearance for conducting the adult SPS-IF trial.
from the European Medicines Agency.
Speaker Change: For the pediatric MVID trial, we are initiating a phase 2 trial in the United States and at additional clinical sites in Europe and the Middle East, North Africa, MENA regions.
Speaker Change: The Pediatric MVID Clinical Protocol has received regulatory clearances from the FDA.
and European Medicines Agency.
Additionally, we are supporting some investigator-initiated proof-of-concept studies.
In adult and pediatric SPSI patient populations.
Speaker Change: to meet their requisite daily needs for nutrition, electrolytes and fluids from total parenteral support.
upon obtaining some initial results in these investigative initial studies.
Speaker Change: And with published proof of concept data, we also have the potential to move towards reimbursed early patient access in certain European markets prior to full product approval in Europe, a program which does not exist in the United States.
Speaker Change: This is also an important strategic advantage for our Napa Therapeutic Subsidiary.
Speaker Change: which means they have lost a part of their interesting, either anatomically or functionally or both.
Speaker Change: And in some cases, these are provided their caloric requirements are provided predominantly through total parenteral nutrition, potentially up to 20 hours in a day, sometimes for all seven days of the week.
Speaker Change: Obviously, this is a catastrophic situation for these patients and their families.
Speaker Change: This anti-secretory mechanism of action of grafelma reduces fluid and electrolyte accumulation in the GI tract and improves stool consistency.
Importantly, due to the shortened length of the intestinal tract.
in SPSI patients.
The oral formulation of profilmo was not suitable.
Unknown Speaker I am not viable.
Speaker Change: Our team has developed a novel, proprietary, highly-concentrated, lyophilized chroforma powder for oral solution formulation.
Speaker Change: Which will be administered orally to these patients in very small volumes.
Speaker Change: to evaluate the effects of profelma on various clinical symptoms, including reduction in stool volume output and the requirements for total parenteral support.
Speaker Change: As you may know, both the FDA and EMA, European Medicines Agency, have approved a growth hormone for the management of adult and pediatric SPSIS patients.
but not for MBID.
Speaker Change: The approved growth hormone is a GLP-2 analog and it functions by promoting growth of villi in the intestinal mucosa, which means it helps increase the length of the villi after surgery or other interventions.
Speaker Change: To help SPS patients, short bowel syndrome patients, increase their fluid and or nutrient absorption from their intestine.
Speaker Change: A key limitation of the mechanism of action of growth hormones is that they cannot be used.
in Cancer Patients.
and inpatients with abnormal hyperproliferative medical conditions.
Speaker Change: As I said earlier, GLP-2, growth hormone, or any other therapies are not approved for pediatric MVID patients.
Speaker Change: and cannot be expected to provide any benefit because these patients, although they have a full intact gut, they do not have any villi. They are brush border. They have no brush border membrane and hence the name microvillous inclusion disease.
Speaker Change: And there are needs for new approaches that are potentially provided by Profelma to reduce their stool volume output and some reduction in their total parenteral support requirements.
Speaker Change: Since grafoma is also not a growth hormone, it does not have any of the limitations of the GLP-2 analogs.
Crofelma is a locally acting drug in the gastrointestinal tract.
Speaker Change: without significant oral absorption, and it provides the ability to reduce chloride secretion into the gut and accompanying fluid accumulation, which will then result in reduction of stool volume output and potentially reduction of total parenteral support requirements.
Speaker Change: Nevertheless, with the approval of GLP analogs, the regulatory endpoint for reduction of total parenteral nutrition has been established.
Speaker Change: The GLP-2 analogs cost approximately $500,000 per year per patient in the U.S. And the cost of TPN with or without supplementary fluids is not included in that. It is in addition to the cost of the GLP-2 analog.
Speaker Change: Lisa, that's the overall summary and I'll hand it back to you for continuing the discussion. Thank you.
Speaker Change: Thank you very much Pravin. Thank you for everything you do. Hang on in case there are any questions for you. Carol we'll turn it over to you now. Wonderful. Good morning Lisa and thank you to all of you who have joined our webcast today.
Carol Lizak: I'll give my review of our financials for the third quarter of 2024.
Carol Lizak: The total net revenue for the companies Mitessi and Canolivia CA1 prescription products
Carol Lizak: The company's non-prescription products and license revenue was approximately $3.1 million in the third quarter of 2024.
representing an increase of approximately 14 percent.
Carol Lizak: versus the total net revenue in the second quarter of 2024, which totaled approximately $2.7 million and an increase of approximately 11% over the total net revenue in the third quarter of 2023.
which totaled approximately 2.8 million.
Carol Lizak: My Tessie prescription volume increased in the 3rd quarter of 2024 compared to the 2nd quarter of 2024 by 10.9%.
Carol Lizak: Prescription volume differs from the invoice sales volume, which reflects among other factors varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.
Carol Lizak: Now, loss from the operations decreased by $1.5 million, from $8.8 million in the quarter ended September 30, 2023, to $7.3 million during the same period in 2024.
Carol Lizak: Gap recurring EBITDA for the third quarter of 2024 and the third quarter of 2023 were a net loss of $9.2 million and $6.2 million, respectively.
Carol Lizak: Debt loss attributable to common shareholders increased by approximately $2.1 million from $7.8 million in the third quarter and September 30 of last year, 2023, to $9.9 million in the same period in 2024.
Speaker Change: Well, that concludes my recap of high-level financials for the third quarter of 2024. I will now hand the discussion back to Lisa.
Speaker Change: Over the next six months, and literally we've heard many in the remainder of 2024, over the next two months in all of our core programs, including profelomer for cancer therapy related diarrhea, the very exciting presentations at San Antonio.
Lisa Conte: The development and the clinical initiatives for MVID and short bowel syndrome intestinal failure, the ongoing commercial launch of GelClear, which will have revenues then that will be reporting in 2025 for the fourth quarter, the company's third prescription product, by the way.
Speaker Change: The Board of Directors has no intention of implementing a reverse split of the company's common stock. So I do get that question often, so let me just...
Speaker Change: preempt that and say the Board of Directors has no intention of implementing a reverse split with these important catalysts and what we feel will be value enhancing and value recognition.
Speaker Change: I also want to comment on the company's mission to change patients' lives for the better and especially, of course, in the supportive care area of complex diseases like cancer, as we have done in HIV.
Speaker Change: chronic pain, there's about 21 different documented side effects associated with cancer care. These should not ever be viewed as acceptable or tolerable. One of the most insulting things you can say to a cancer patient, and in particular a metastatic patient,
Speaker Change: who's likely to be on some sort of therapy or targeted therapy for the rest of their life, is that this is a reported side effect that is a tolerable toxicity. Tolerable to whom?
Speaker Change: And this is a belief of the core message of our ongoing Make Cancer Less Shitty campaign.
Speaker Change: which seeks to broadly acknowledge the rigors of both short-term and perpetual treatment by sharing the voices and the stories of individuals that are living with this experience. And the point is to live with the cancer experience, not just exist.
Speaker Change: The Make Cancer Less Shitty campaign now has six patient ambassadors and you can learn about and hear these remarkable people and our commitment to their campaign on the website
Speaker Change: www.MakeCancerLessShitty, I think everybody knows how to spell that, and the primary social media channel for Make Cancer Less Shitty campaign is Twitter, X, under the handle CancerSuckLess.
Speaker Change: So with that, I will, before signing off, I'm going to go look to see if there are any written questions. So give me a second here.
And okay.
Speaker Change: Question number one. Are we looking to partner with the right company to enhance the pipeline? Are you looking into institutional investors?
Absolutely, we are looking to institutional investors.
Speaker Change: Great liquidity in the StockJAGX, which is a reflection of the large retail holding that we have, which is terrific, liquidity is wonderful for everyone, and liquidity is also a factor that attracts institutional investors.
So with the key catalyst we have coming up.
Speaker Change: introducing the story or reintroducing the story to institutional investors on a global basis, in particular, as I mentioned, because we do have clinical trials going on around the world. And often that can be an opening of interest to investors in different geographical areas.
Speaker Change: As far as partnering, we have global unencumbered rights to Profelimer. We do have partners, for example, we have a partnership with a wonderful company, Genelac in Turkey, about seven different Eastern European countries. We have another partnership in the Mideast.
Right now in Europe, those rights are...
are encompassed within NAPO Therapeutics, are subsidiary in Milan.
Speaker Change: There is always the opportunity. There are always business development discussions going on for the potential.
Speaker Change: to have an appropriate partner for late stage development of commercialization and to bring in non-dilutive dollars. So there is the balance of the long-term commercial impact that is given up if we
though.
Speaker Change: Pravin, I'm going to send this to you. It's a question about the extension data from the 12 weeks in the OnTarget trial. Maybe you could explain, remind everybody what that extension period is and what we intend to do with that data.
Okay, thank you for the question.
Speaker Change: So, we right now have been focused singularly on the placebo-controlled blind at early 12, first 12-week stage of the study, which is the responder analysis that we were preparing to submit and which is accepted for the San Antonio Breast Cancer Conference.
Speaker Change: We have also collected the data for those patients who self-selected, whether they were on placebo or active, to continue into another 12-week period because the dose would not have been known. Our protocol did not allow patients to get open-label Crofelmer.
Speaker Change: So, a smaller number of patients than the patients that were randomized in the stage 1 went into stage 2, and we are going to evaluate that data.
After we've gone through the stage one.
Analysis completed.
Speaker Change: So, currently, we are, as I mentioned in my briefing to all of you, that as we prepare to go talk to the FDA, our emphasis of the data will primarily be on the responder analysis of the first 12 weeks, but we will also take the signals that we get in the second stage
Speaker Change: specifically for breast cancer subgroups. So remember, not all patients were only subgroup of breast cancer that went into stage two. So we think
that we will have a subset of the analysis done.
Speaker Change: That's a longer and a bigger proposition, so we will take some longer time for it. It will appear sometime in the mid to late, mid to second half of next year for the entire study. Hopefully, Lisa, that gives you the answer about how we are planning to do it.
Speaker Change: Thank you. And I've got one more question here, a question about achieving profitability in the biotech sector in development stage pharmaceutical companies.
to the company's profitability, GelClear, which has just been launched.
Speaker Change: Obviously, we put together a commercialization plan to get to a positive contribution as soon as possible.
And when I say blockbuster, I mean first and foremost.
Speaker Change: the impact on patients and the unmet needs, which is a commonly used phrase, but absolutely clear in our indications. For example, the white space, nothing available for
Speaker Change: that is satisfactory for mucositis, for cancer therapy related diarrhea. So patients can stay on their targeted therapy in a metastatic situation for the rest of their lives in a curative situation for months and years sometimes. The 21 different side effects.
Transcripts provided by Transcription Outsourcing, LLC.
Speaker Change: an active ingredient that's already approved with chronic safety, with manufacturing, the two most common reasons why new drug applications get pushed back or fail. So, we are focusing on major blockbuster needs.
Speaker Change: with as much risk reduction as possible and the investment into that.
Speaker Change: And the blockbuster impact will be for all the stakeholders, not just patients and the healthcare professionals, but shareholders and, as I mentioned, all the stakeholders in the company. And that's what the mission of this company is all about.
Speaker Change: So, I think I've hit all the questions, or I've certainly hit all the questions that I see on...
Speaker Change: computer here. So, thank you all. There is one more. What did I miss? Yeah, I think it's directed at me. Can discussions with FDA be fast-tracked?
Oh, okay. I just saw that. Go ahead.
Yeah, so the short answer is no.
Speaker Change: The FDA is absolutely efficient in responding to everything, but they have so many requests for meetings and everything, so it is first in, first out, and it depends on the unmet need and the impact factor.
Speaker Change: So the FDA does the best job to expedite whatever is necessary, but they do a thorough job because ultimately they are first a consumer safety organization.
Speaker Change: And so they take very careful approach to evaluating. So the discussions with FDA cannot be fast-tracked.
Speaker Change: They can give a fast-track designation or a good breakthrough designation to the development plans of the drug if they determine that that is actually worthwhile. So that's a discussion, that's a separate discussion, but not the timing of when we can meet with them. Hope that answers it, Lisa.
Speaker Change: Yeah, and just to clarify and that's referring to the the cancer
Speaker Change: Discussions, which is my testy, which is a product that's already approved. So these are discussions about the efficacy results and they, you know, we often hear risk benefit. I like to talk about it as benefit risk. When we talk about my testy, because.
Speaker Change: The benefit is the benefit that we'll be presenting at San Antonio and the risk for a product that's been on the market for almost a decade at this point with no serious drug-related adverse events. The risk is very, very low if not.
Speaker Change: 0. So what happens when you have benefit divided by zero?
Speaker Change: to infinity and beyond. Okay. Um, with that, we will, uh,
Speaker Change: finish up this call. Thank you all for listening. Thank you all for your support of Jaguar, NAPO, NAPO Therapeutics. Have a wonderful holiday, a wonderful year, and we will be back doing this in 2025.
Speaker Change: This concludes today's teleconference. You may disconnect your lines at this time. Thank you again for your participation.