October 3, 2022

JAGX Profile2

OUR NEW PROFILE IS:   (NASDAQ: JAGX)

Mytesi®  is approved by the U.S. Food and Drug Administration for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy

Prescription product net revenue of $2.9 million in Q2 2022 increased approximately 12.0% Quarter over Quarter, over Q1 2022; and increased approximately 641% Year over Year, over Mytesi® net revenue in Q2 2021

CHECK OUT THE CORPORATE PRESENTATION HERE

*****BREAKING NEWS JUST RELEASED MINUTES AGO*****

Jaguar Health Provides Company Updates and Reports 2022 Second Quarter Financials

Prescription product net revenue of $2.9 million in Q2 2022 increased approximately 12.0% Quarter over Quarter, over Q1 2022; and increased approximately 641% Year over Year, over Mytesi® net revenue in Q2 2021

Core initiatives:

  • OnTarget Phase 3 clinical trial of crofelemer for prophylaxis of cancer therapy-related diarrhea (CTD) adding international sites, targeting completion of enrollment 1H 2023
  • Expected presentation in December 2022 of results of a third-party, investigator-initiated proof-of-concept trial of crofelemer for short bowel syndrome (SBS), supporting the potential for expanded patient access through programs in Europe in 2023
  • Ongoing launch of Canalevia®-CA1 for treatment of chemotherapy-induced diarrhea (CID) in dogs

REMINDER: Jaguar to host investor webcast Monday, August 22nd at 8:30 a.m. Eastern regarding second quarter 2022 financials and company updates; Click here to register for webcast

SAN FRANCISCO, CA / ACCESSWIRE / August 22, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) today provided Company updates and reported consolidated second-quarter 2022 financial results.

Prescription product net revenue was approximately $2.9 million in the second quarter of 2022, representing an increase of approximately 12% over Mytesi net revenue in the first quarter of 2022, which totaled approximately $2.6 million, and an increase of approximately 641% over Mytesi net revenue in the second quarter of 2021, which totaled approximately $0.4 million.

“We are very pleased that growth in Mytesi (crofelemer) revenue continued in the second quarter of 2022,” said Lisa Conte, Jaguar’s president and CEO. “We completed the full shift this past January to a patient access strategy that involves transitioning to a limited distribution network of specialty pharmacies, which reduced our distribution costs and improved our Mytesi gross-to-net ratio dramatically. It is wonderful to see Mytesi growth continuing following this transition and the other components of our Mytesi patient access program, including our ongoing educational and promotional activities in 2022 and the launch this past May of our telehealth initiative for Mytesi. Most importantly, we are pleased with the realization of our mission of providing relief with a novel, plant-based, first-in-class mechanism of action to patients in need – including patients for whom no alternative therapeutic options exist.”

“Jaguar is focused on two late-stage clinical events in the next approximately 6 to 12 months that we expect to be transformational in terms of value creation and recognition for the Company. We anticipate the completion in 2022 of an investigator-initiated proof-of-concept study of crofelemer for short bowel syndrome (SBS), supporting the potential for expanded patient access to crofelemer in Europe in 2023 for this devastating and often catastrophic disease for these patients, who are frequently on parenteral nutrition for as long as 20 hours a day, seven days a week. The third-party investigator, Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City, is targeting the presentation in December 2022 of results from the SBS study at a global GI conference in Dubai. Our second key clinical activity is our Phase 3 pivotal OnTarget trial of crofelemer for our core follow-on indication of prophylaxis of cancer therapy-related diarrhea (CTD). We expect enrollment in this pivotal trial to complete in the first half of 2023,” Conte said.

2022 MILESTONES, UPDATES & ACCOMPLISHMENTS:

  • Phase 3 clinical trial of crofelemer for cancer therapy-related diarrhea (CTD) in humans: The pivotal OnTarget Phase 3 clinical trial of crofelemer for prophylaxis of CTD was initiated in October 2020and is ongoing. The Company is in the process of adding additional clinical trial sites – both in the US and outside the US – to accelerate patient enrollment. Further details about the trial can be viewed here on the clinicaltrials.gov website. Is it estimated that 50-80% of chemotherapy patients experience diarrhea,1 and diarrhea has the potential to cause dehydration, potential infections, and non-adherence to treatment in cancer patients. Patients with CTD are 40% more likely to discontinue their chemotherapy or targeted therapy than patients without CTD,2 and the cost of care of CTD patients is estimated to be 2.9 times higher than for patients who are not experiencing CTD.3
  • 2022 & 2023 Milestones: Completion of investigator-initiated proof-of-concept studies of crofelemer for SBS and congenital diarrheal disorders (CDD) with intestinal failure: Napo Therapeutics, the Italy-based company Jaguar established under exclusive license to crofelemer in Europe, is supporting planned investigator-initiated studies of crofelemer in patients with SBS or CDD with intestinal failure, with a planned primary endpoint of reduction of weekly volume of parenteral nutrition. On December 13, 2021, the EMA granted Orphan Drug Designation (ODD) for crofelemer for SBS in the European Union, and crofelemer has received ODD in the U.S. for SBS. The EMA is committed to enabling early patient access to new medicines, particularly those that target an unmet medical need, and ODD status in the EU is expected to support Napo Therapeutics’ plans to make crofelemer available through Early Access Programs in the EU for SBS. Participation in Early Access Programs provides a potential opportunity for meaningful revenue generation in addition to the ability to impact important morbidity, mortality, and the cost of care for chronically ill patients for whom no good therapeutic options exist. SBS affects approximately 10,000 to 20,000 people in the U.S.,4 according to the Crohn’s & Colitis Foundation, and it is estimated that the population of SBS patients in Europe is approximately the same size.5 Despite limited treatment options, the global SBS market exceeded $568 million in 2019 and is expected to reach $4.6 billion by 2027, according to a report by Vision Research Reports.
  • May 2022 submission of an Orphan Drug Designation (ODD) application to the European Medicines Agency (EMA) for crofelemer for a rare congenital diarrheal disorder (CDD): Napo Therapeutics, the Italian corporation established by the Company in Italy in 2021 that focuses on expanding crofelemer access in Europe, submitted a CDD ODD application for crofelemer to the EMA. CDDs are a group of inherited chronic enteropathies characterized by heterogeneous etiology, and each type of CDD is thus a different disease with a different pathogenetic mechanism. CDD is a life-threatening and rare autosomal recessive disease that affects newborns and children and leads to significant morbidity and even death from severe secretory diarrhea.
  • Q3 2022 Milestone: Filing of an Investigational New Drug (IND) application with the FDA for NP-300 (lechlemer) for the symptomatic relief of diarrhea from cholera: Lechlemer is the Company’s drug product candidate for symptomatic relief of diarrhea from cholera. It is a standardized and proprietary botanical drug product that is sustainably derived from the same source as crofelemer – the Croton lechleri tree – and works by the same mechanism of action as crofelemer. In support of the planned IND application filing for lechlemer, the Company received comprehensive animal toxicity preclinical services supported by the National Institute of Allergy and Infectious Diseases for four preclinical studies. The Company intends to pursue a tropical disease priority review voucher under the FDA’s financial incentive program to develop drugs for tropical diseases such as cholera. Priority review vouchers are transferable, and in past transactions by other companies have sold for prices ranging from $67 million to $350 million, which provides for a potential immediate return on investment upon approval of the product for the symptomatic relief of diarrhea from cholera.
  • 2022, Jaguar’s Year of the Dog: Launch activities remain underway for Canalevia-CA1 in the U.S. veterinary market for the treatment of chemotherapy-induced diarrhea (CID) in dogs, and the second quarter of 2022 is the first Canalevia-CA1 revenue recognition period for the Company. Canalevia-CA1 was the focus of Jaguar Animal Health’s activities at April’s Veterinary Cancer Society Mid-Year Conference in Puerto Vallarta, Mexico. Jaguar Animal Health exhibited at the June 23-25, 2022 American College of Veterinary Internal Medicine (ACVIM) Forum in Austin, Texas, and will be exhibiting at the September 7-11, 2022 International Veterinary Emergency and Critical Care Symposium (IVECCS) in San Antonio, Texas, and at the October 13-15, 2022 Veterinary Cancer Society (VCS) Annual Conference in Norfolk, Virginia. Dogs, as with humans, go off their disease modifying chemotherapy approximately 40% of the time due to diarrhea, and dogs are a predictive model of the human situation. Jaguar expects that Canalevia could additionally receive FDA conditional approval, under the name Canalevia®-CA2, for the treatment of exercise-induced diarrhea (EID) in dogs in the next 6-8 months.
  • Jaguar’s Canine Cancer: Take C.H.A.R.G.E. (Canine Health And ReGistry Exchange) initiative launched with a special media event and performance in New York City on May 23, 2022. Take C.H.A.R.G.E. established the first-ever U.S. canine cancer national registry and cancer care index to assess the prevalence and incidence of cancer in dogs. The mission is important, because protecting dogs from cancer begins with knowing its impact by breed, type, age, gender, and location. The data may also provide insights to help better understand cancer in humans and the importance of managing side effects in human cancer therapy. On August 10, 2022, Gallup published an article providing their analysis of results from Take Charge of Canine Cancer, the first-ever nationally representative survey of U.S. dog owners’ experiences with the disease. The survey, which comprises the Index component of the Take C.H.A.R.G.E. initiative, found that of the 67% of Americans who have had at least one dog in the past 10 years, nearly one in five – equating to approximately 30 million people – say at least one of their dogs has experienced cancer. Gallup’s article, which can be viewed by clicking here, also describes the Take C.H.A.R.G.E. initiative.

Ongoing business development initiatives in 2022:

  • In June 2022, as announced, Jaguar entered an exclusive license and services agreement with Ontario, Canada-based SynWorld Technologies Corporation (SynWorld) for the treatment of diarrhea in dogs in the China market with Jaguar’s Canalevia drug product. Per the terms of the agreement, Jaguar has engaged SynWorld as a service provider to obtain regulatory approval of the product for Jaguar in China and granted SynWorld a license to commercialize and sell this product following such approval in China. As consideration for the license, Jaguar is entitled to receive 60% of any profits from sales of the product in China. If Jaguar reimburses SynWorld for the direct expense of obtaining regulatory approval in China, the profit sharing will be 80% and 20%, respectively, for Jaguar and SynWorld. The agreement also entails monthly license fee payments by SynWorld to Jaguar amounting to US $5.0 million in total during the initial two-year term of the agreement, realized as a commitment by SynWorld to make quarterly purchases of Jaguar common stock (purchased at market price in unregistered stock at the time of purchase). As consideration for the regulatory services to be provided by SynWorld, Jaguar will pay SynWorld a monthly service fee up to U.S. $5.0 million in total over the initial two-year term of the agreement in the form of unregistered Jaguar stock.
  • In June 2022, as announced, Jaguar and Filament Health signed a letter of intent to enter a collaboration agreement to develop botanical prescription drugs for specific psychoactive target indications in the United States. The goal of the collaboration is to extend the botanical drug development skillsets of both companies in order to develop pharmaceutical-grade, standardized drug candidates and partner with a potential future licensee regarding the development and commercialization of these novel plant-based drugs for indications such as attention-deficit/hyperactivity disorder (ADHD) and social anxiety disorder. Jaguar’s Entheogen Therapeutics Initiative (ETI) aims to discover and develop groundbreaking, novel, natural medicines derived from psychedelic and psychoactive plants for treatment of mood disorders, neurodegenerative diseases, addiction, and mental health disorders. Jaguar is in discussions with potential partners for this initiative.
  • The Company is continuing to manage its relationship with Quadri Pharmaceuticals Store LLC (Quadri Pharma) following the execution on March 31, 2022 of an exclusive crofelemer distribution and license agreement for multiple target indications in Middle East markets. As announced, the agreement grants Quadri Pharma exclusive promotional, commercialization, and distribution rights for specified human indications of crofelemer in Bahrain, Kuwait, Qatar, Saudi Arabia, the United Arab Emirates, and Oman following regulatory approval to market crofelemer in these countries for the specified indications, including the indication currently approved in the U.S. for HIV-related diarrhea, and cancer therapy-related diarrhea. In addition, the agreement grants Quadri Pharma exclusive rights to distribute crofelemer in these countries in the immediate future under Named Patient Programs. Jaguar expects patients in this territory to be able to access crofelemer before the end of 2022.
  • Jaguar is continuing efforts to forge additional license and business development relationships in key markets around the globe.

Updates about recent and currently active investigator-initiated trials of crofelemer:

  • Investigator-initiated HALT-D trial evaluating crofelemer for preventing chemotherapy-induced diarrhea (CID) in HER2-positive breast cancer patients: The full results of this study, which were presented at the San Antonio Breast Cancer Symposium (SABCS 2021) in December 2021, are being submitted to a medical journal in 2022 for consideration for publication.
  • Chronic idiopathic diarrhea in non-HIV adult patients
    • Study Name: Yield of Diagnostic Tests and Management of Crofelemer for Chronic Idiopathic Diarrhea in Non-HIV Patients: A Pilot Study
    • Location: University of Texas Health Science Center at Houston
  • Functional diarrhea in non-HIV adult patients
    • Study Name: A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of crofelemer in subjects with functional diarrhea
    • Location: Beth Israel Deaconess Medical Center, a Harvard Medical School institution in Boston

2022 SECOND QUARTER COMPANY FINANCIAL RESULTS:

Prescription product net revenue was approximately $2.9 million in the second quarter of 2022, representing an increase of approximately 12% over Mytesi net revenue in the first quarter of 2022, which totaled approximately $2.6 million, and an increase of approximately 641% over Mytesi net revenue in the second quarter of 2021, which totaled approximately $0.4 million.

“Mytesi total prescription volume increased 8.2% in the second quarter of 2022 over the first quarter of 2022,” said Ian Wendt, Jaguar’s Chief Commercial Officer. “As previously announced, the transition we completed this past January 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 am very pleased to report that we significantly outperformed the industry gross-to-net average in the second quarter of 2022 – as we did in both of the two previous quarters – for sales of our human prescription product. 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, and SBS. Additionally, the transition has allowed us to begin utilizing sales and prescription data directly provided by our network of specialty pharmacies to more accurately track prescription metrics.”

The Company believes the availability of Mytesi through specialty pharmacies represents a significant benefit to patients, as such pharmacies focus on complex and chronic conditions and offer a higher level of support for prior authorizations, appeals, adherence reminders and counseling, and home delivery options.

  • Mytesi Prescription Volume: As stated above, Mytesi prescription volume increased 8.2% in the second quarter of 2022 over 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.
  • Mytesi Net Product Revenue: Mytesi net revenue during the second quarter of 2022 was approximately $2.8 million and approximately $2.6 million in the first quarter of 2022, an increase of approximately $0.2 million, or approximately 10%, quarter over quarter, and an increase of approximately 644% over Mytesi net revenue in the second quarter of 2021, which totaled approximately $0.4 million. The transition to a limited distribution network of specialty pharmacies, which was completed this past January, resulted in a meaningful reduction in Mytesi distribution costs and a higher average net price. As part of the process of transitioning to the closed specialty pharmacy network, the third and fourth quarters of 2021 were significantly impacted by the inventory draw-down of approximately 1,300 bottles of Mytesi across the Company’s third-party logistics warehouse, wholesalers, distributors, and retail stores.
  • Mytesi Gross Product Revenue (Non-GAAP): Mytesi gross revenue was approximately $3.7 million in the second quarter of 2022 and $3.4 million in the first quarter of 2022, representing an increase of approximately $0.3 million or 9% quarter over quarter, and a decrease of approximately 24% over Mytesi gross revenue in the second quarter of 2021, which totaled approximately $4.9 million.
  • Canalevia-CA1 Net Product Revenue: Canalevia-CA1 (crofelemer delayed-release tablets), the Company’s prescription drug product for the treatment of chemotherapy-induced diarrhea (CID) in dogs, became commercially available to veterinarians across the U.S. at the end of April 2022. Canalevia-CA1 net and gross revenue during the second quarter of 2022 were approximately $87.4 thousand.
  • Neonorm: Revenues for the non-prescription Neonorm products and Jaguar’s Animal Health business unit were minimal for the second quarters of 2022 and 2021, in accordance with the Company’s primary focus on human health and prescription products.
Three Months Ended
Financial Highlights (in thousands) June 30,
Gross product sales 2022 2021 $ change % change
Mytesi $ 3,671 $ 4,922 $ (1,251 ) -34 %
Neonorm 15 6 9 60 %
Canalevia 87 87 100 %
Total gross product sales 3,773 4,928 (1,155 ) -31 %
Sales rebates (523 ) (1,354 ) 831 -159 %
Sales discounts (318 ) (2,600 ) 2,282 -718 %
Sales returns (11 ) (48 ) 37 -336 %
Wholesaler fee (541 ) 541 0 %
Net product sales $ 2,921 $ 385 $ 2,536 87 %
Mytesi Sales: Gross to Net
Gross sales $ 3,671 $ 4,922 $ (1,251 ) -34 %
Sales rebates, discounts and returns (852 ) (4,543 ) 3,691 -433 %
Net Mytesi Sales 2,819 379 2,440 87 %
Three Months Ended
Financial Highlights June 30,
(in thousands, except per share amounts) 2022 2021 $ change % change
Net product revenue $ 2,921 $ 385 2,536 87 %
Loss from operations $ (6,479 ) $ (11,580 ) 5,101 -79 %
Net loss $ (9,390 ) $ (14,081 ) 4,691 -50 %
Net loss per share, basic and diluted $ (0.12 ) $ (0.31 )
  • Cost of Product Revenue: Total cost of product revenue for the quarter ended June 30, 2022 was $0.5 million compared to $0.7 million for the quarter ended June 30, 2021. The decrease of $0.2 million was largely due to lower distribution and channel rebate/discount costs that resulted from the shift to the specialty pharmacies distribution model.
  • Research and Development: The R&D expense was $2.5 million for the second quarter of 2022 compared to $3.9 million for the second quarter of 2021, a decrease of $1.4 million. Clinical, contract manufacturing, personnel and related benefits decreased approximately $1.0 million in the second quarter of 2022 compared to the same period in 2021. During the second quarter of 2022 certain personnel and related benefits were capitalized as internally developed software costs for the Canine Cancer: Take C.H.A.R.G.E.Registry. Consulting, formulation and regulatory fees decreased $0.7 million from $0.9 million in the three months ended June 30, 2021 to $0.2 million in the same period in 2022. The decrease was due to lower clinical trial consulting costs.
  • Sales and Marketing: The Sales and Marketing expense was $2.1 million for the second quarter of 2022 compared to $2.2 million for the second quarter of 2021, a decrease of $0.1 million.
  • General and Administrative: The G&A expense was $4.3 million for the second quarter of 2022 compared to $5.1 million for the second quarter of 2021. The decrease of $0.8 million was largely due to a reduction of $0.1 million in personnel and related benefits, $0.5 million in public company expense and $0.1 in consulting costs. This is offset by increases of $0.03 million in travel expenses due to loosening of Covid-related travel restrictions, $0.1 million in rent and $0.7 million in Company financing activities.
  • Loss from Operations: For the second quarter of 2022, the loss from operations was $6.5 million compared to a loss of $11.6 million in the second quarter of 2021, a decrease of $5.1 million.
  • Net Loss: For the second quarter of 2022, the net loss attributable to common shareholders was approximately $9.4 million, compared to a net loss of $14.1 million in the second quarter of 2021, a decrease of approximately $4.7 million quarter over quarter. In addition to the loss from operations:
  • Interest expense increased by $0.5 million from $2.0 million in the three months ended June 30, 2021 to $2.5 million for the same period in 2022 primarily due to interest from the royalty and note agreements.
  • Change in fair value of financial instruments and hybrid instruments designated at fair value option (FVO) losses increased $1.2 million from a loss of $0.5 million in the three months ended June 30, 2021 to a gain of $0.7 million for the same period in 2022.
  • Other expense increased by $1.1 million from $0.02 in the three months ended June 30, 2021 to $1.1 million for the same period in 2022 due to the foreign currency transactions.
  • Non-GAAP EBITDA: Non-GAAP EBITDA for the second quarter of 2022 and the second quarter of 2021 was a net loss of $5.4 million and $10.8 million, respectively.
Three Months Ending
June 30,
(in thousands) 2022 2021
(unaudited)
Net loss $ (9,390 ) $ (14,081 )
Adjustments:
Interest expense 2,536 2,009
Property and equipment depreciation 10 8
Amortization of intangible assets 422 422
Share-based compensation expense 1,017 892
Income taxes
Non-GAAP EBITDA (5,405 ) (10,750 )
Impairment of indefinite-lived intangible assets
Loss on extinguishment of debt
Series 3 warrants inducement expense
Series B convertible preferred stock inducement expense
Non-GAAP Recurring EBITDA $ (5,405 ) $ (10,750 )

Note Regarding Use of Non-GAAP Measures

The Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing gross sales, non-GAAP EBITDA, and non-GAAP recurring EBITDA, which are considered non-GAAP under applicable SEC rules. 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 are not in accordance with GAAP and 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.

Gross sales percentages issued by the Company are based on gross sales figures that represent Mytesi orders placed by select Specialty Pharmacies with Jaguar’s third-party logistics warehouse, less allowances for rebates and discounts, which generate the cash flows for Napo Pharmaceuticals, Inc. (“Napo”), Jaguar’s wholly owned subsidiary. Gross sales are used internally by management as an indicator of and to monitor operating performance, including sales performance of Mytesi, salesperson performance, and product growth or declines. Gross sales are not a measure that is recognized under accounting principles generally accepted in the United States of America (“GAAP”) and should not be considered as an alternative to net sales, which is determined in accordance with GAAP, and should not be used alone as an indicator of operating performance in place of net sales. Additionally, gross sales may not be comparable to similarly titled measures used by other companies, as gross sales have been defined by the Company’s internal reporting practices. In addition, gross sales may not be realized in the form of cash receipts as promotional payments and allowances may be deducted from payments received from certain customers. Mytesi gross sales are reduced by specialty pharmacy discounts, Medicare rebates, Medicaid rebates, 340B discounts, ADAP rebates, VA rebates, copay program costs, prompt pay discounts, and returns based on historical trends to determine net sales.

The Company defines non-GAAP EBITDA as net loss before interest expense and other expense, depreciation of property and equipment, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. The Company defines non-GAAP Recurring EBITDA as non-GAAP EBITDA adjusted for certain non-recurring revenues and expenses. Company management believes that non-GAAP EBITDA and non-GAAP Recurring EBITDA are meaningful indicators of Jaguar’s performance and provide useful information to investors regarding the Company’s results of operations and financial condition.

Participation Instructions for Webcast
When: Monday, August 22, 2022, at 8:30 AM Eastern Time
Participant Registration & Access Link: Click Here

Replay Instructions for Webcast
Replay of the webcast on the investor relations section of Jaguar’s website: (click here)

About Jaguar Health, Jaguar Animal Health, Napo Pharmaceuticals, & Napo Therapeutics

Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Animal Health is a tradename of Jaguar Health. Jaguar Health’s wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe.

For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com.

About Mytesi®

Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).

See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.

Important Safety Information About Canalevia®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

See full Prescribing Information at Canalevia.com.

___________________

Hello Everyone,

We have a company back on our radar for Monday’s session that we recently took a look at just under two weeks ago.

We profiled it before the open and it saw gap up about a penny and a half gap and opened at .285.  It moved up over the next few sessions hitting a high of .32 for a nice 12% move in just a few sessions.  Over the past few sessions it has seen a little bit of a pullback and is sitting around .27 right now.

We have a major catalyst to look at today:

 

 

There will be a lot of eyes on these earnings today with this one trading for such a low price right now.

There is also another catalyst to look at:

Long story short, the company has a lot of motivation to do everything they can to move the price of this one up over the next 6 months.  If the company has any positive news to be released, you can assume it will be coming out in the next few months.

Make sure JAGX is on your screen right now.  

Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, specifically chronic, debilitating diarrhea. Jaguar Animal Health is a tradename of Jaguar Health. Jaguar Health’s wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest areas. Napo Pharmaceuticals’ Mytesi® (crofelemer) product is approved by the U.S. Food and Drug Administration for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and is the only oral plant-based prescription medicine approved under FDA Botanical Guidance. Crofelemer is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy.
Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A., an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on a rare disease business model, including an initial focus on the orphan designation of crofelemer for short bowel syndrome for which proof of concept data is expected in the next 6 months. Napo Therapeutics is pursuing the rare disease strategy to bring crofelemer to patients in need, potentially in 2023, under the reimbursed expanded patient access program that exists in EU.

Most people I know are dog people.  How how could you not be?  My most recent dogs were small and both lived a long time.  I spent tens of thousands of dollars on each of them to keep them alive at different points in their lives.  We had to go the the vet for everything  from cut paws to pancreas surgery and then some.  Think about how many people you know who’s pets are part of their family.  Unfortunately, roughly 1 in 4 dogs will, at some stage in their life, develop neoplasia.  Almost half of dogs over the age of 10 will develop cancer. According to theNational Cancer Institute, roughly 6 million new cancer diagnoses are made in dogs each year in the U.S.

The market is substantial.

 

Jaguar Health Enters Exclusive Crofelemer License and Commercialization Agreement with SynWorld Technologies for Canalevia for Treatment of Diarrhea in Dogs in China

License fees of $5.0 million, and up to $5.0 million in unregistered equity infusion, over next 24 months

Service agreement of up to $5.0 million payable in unregistered Jaguar stock to SynWorld to support approval of crofelemer in China, providing Jaguar Health with up to 80% of profits

SAN FRANCISCO, CA / ACCESSWIRE / June 29, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that the company has entered an exclusive license and services agreement with Ontario, Canada-based SynWorld Technologies Corporation(SynWorld) for the treatment of diarrhea in dogs in the China market with Jaguar’s Canalevia® (crofelemer delayed-release tablets) prescription drug product.

“We are very excited about the possibility of making Canalevia available in China as part of the license we have provided to SynWorld for crofelemer for treatment of diarrhea in dogs in this territory,” said Lisa Conte, Jaguar’s founder, president, and CEO. “Per the terms of the agreement, Jaguar is engaging SynWorld as a service provider to obtain regulatory approval of the product for Jaguar in China and granting SynWorld a license to commercialize and sell this product following such approval in China. As consideration for the license, Jaguar is entitled to receive 60% of any profits from sales of the product in China. If Jaguar reimburses SynWorld for the direct expense of obtaining regulatory approval in China, the profit sharing will be 80% and 20%, respectively, for Jaguar and SynWorld.”

The agreement also entails monthly license fee payments by SynWorld to Jaguar amounting to US $5.0 million in total during the initial two-year term of the agreement, and a commitment by SynWorld to make quarterly purchases of Jaguar common stock (purchased at market price in unregistered stock at the time of purchase), amounting to US $5.0 million of Jaguar stock purchased in total, during the initial two-year term of the agreement. As consideration for the regulatory services to be provided by SynWorld, Jaguar will pay SynWorld a monthly service fee up to U.S. $5.0 million in total over the initial two-year term of the agreement in the form of unregistered Jaguar stock, with the value of such stock equal to market price at the time of such issuance. Under no circumstances will stock under the agreement be issued below market price on the commencement date of the license agreement. Additionally, under no circumstances will the number of shares of common stock issued under the agreement (i) exceed 19.99% of the total Jaguar shares outstanding as of the date of the agreement or (ii) result in the total number of shares of common stock held by SynWorld and its affiliates exceeding 19.99% of total Jaguar shares outstanding at any given time, in each case unless stockholder approval is obtained. The agreement includes customary termination provisions including the right of either party to terminate the agreement for material breach of the agreement by the other party.

“We are especially pleased with the infusion of capital into Jaguar expected over time from this agreement. This anticipated contribution to Jaguar’s financial health not only supports these efforts to expand Canalevia availability to China, it will support Jaguar’s goal of realizing value from progress in the development of the human pipeline of crofelemer, specifically: (i) the targeted completion of enrollment by the end of Q2, 2023 for the OnTarget Phase 3 study of crofelemer for the prophylaxis of cancer therapy-related diarrhea; and (ii) the completion and publication of proof-of-concept data for the orphan indications of short bowel syndrome (SBS) and potentially congenital diarrheal disorders (CDD) in 2022, supporting potential approval from the European Medicines Agency for early patient access to product in the European Union for SBS and CDD – an effort led by Napo Therapeutics, the rare disease-focused company Jaguar established in Europe in 2021 that has an exclusive license to crofelemer in Europe,” said Conte.

Crofelemer, under the name Canalevia®-CA1, received conditional approval from the U.S. Food and Drug Administration on December 21, 2021 for the treatment of chemotherapy-induced diarrhea (CID) in dogs in the United States, and Jaguar is currently pursuing FDA conditional approval of Canalevia for treatment of exercise-induced diarrhea (EID) in dogs in the US. This license agreement has the potential to significantly improve and/or expand the value of Jaguar’s Canalevia-related intellectual property portfolio.

According to Frost & Sullivan’s 2018 China Pet Industry Report, there were approximately 74 million pet dogs in China at the end of 2018, the number of pet-owner households in China increased from 69.3 million in 2013 to 99.8 million in 2018, and the market size of China’s overall pet industry is projected to reach an estimated RMB472.3 billion (US $70.5 billion) by 2023 – an 800 percent increase compared to 2013.

“The Chinese pet market has been expanding very rapidly, thanks to fast-rising pet ownership driven by a younger generation of consumers who view dogs and cats as embedded members of the family,” said Tao Wang, SynWorld’s General Manager, “and this growth is projected to continue. We look forward to creating a sales channel for the Chinese pet market and plan to directly sell Canalevia through already-existing sales and distribution partnerships in China following approval of the product in this territory.”

About SynWorld Technologies Corporation

SynWorld Technologies Corporation employs cutting edge technology to facilitate opportunities for companies in the U.S. to reach international markets, specifically, China. This is particularly important for publicly traded U.S. based companies who need distribution and Chinese compliance-related logistic partnerships.

PRODUCTS AND PIPELINE

Mytesi

Mytesi® (crofelemer), a product of Jaguar’s wholly-owned subsidiary Napo Pharmaceuticals, is approved by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.

Mytesi is a novel, first‑in‑class anti‑secretory agent which has a basic normalizing effect locally on the gut, and this mechanism of action has the potential to benefit multiple gastrointestinal disorders. Jaguar, through Napo, holds extensive global rights for Mytesi. Mytesi is in development for multiple possible follow‑on indications, including diarrhea related to targeted cancer therapy; orphan‑drug indications for infants and children with congenital diarrheal disorders and short bowel syndrome; supportive care for inflammatory bowel disease; irritable bowel syndrome; and for idiopathic/functional diarrhea. In addition, a second‑generation proprietary anti‑secretory agent is in development for cholera.

Crofelemer, the active ingredient in Mytesi®, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.

 

The term ethnobotanical refers to the use of plants by indigenous people in the course of their everyday lives, including the use of plants for medicine. Crofelemer, the active pharmaceutical ingredient in Mytesi, is derived from the Amazonian tree species, Croton lechleri, and has a rich history of medicinal use by indigenous peoples in the Western Amazon rainforests of South America. The tree produces a blood red latex from which crofelemer is isolated and purified. The tree is commonly called “Sangre de drago” in Spanish, which translates to “Dragon’s blood” in English.

Croton lechleri tree
Croton lechleri tree

The Croton lechleri tree is one of the most widely used plant-derived medicines in the western hemisphere. Red latex from Croton lechleri trees continues to be part of rural and urban traditional medicine in multiple countries including Peru, Colombia, Ecuador, and Bolivia.

Indigenous people utilize the red latex to treat a variety of medical conditions. Its most common uses are taking small quantities of the latex orally to treat diarrhea, stomach ulcers, coughs, and flu. The red latex is also applied topically as a wound healing agent for cuts and open sores, and for healing the gums after tooth extractions. It has been and continues to be used to treat humans as well as dogs and livestock.

Because of its widespread medicinal use, there has been extensive research conducted on the chemistry and pharmacology of this red latex. Mytesi is the result of decades of research that began with the expertise of traditional healers of the Amazon Rainforest.

The Croton lechleri tree is rapidly growing and abundant in multiple countries. Jaguar and its predecessor companies always focus on the long-term sustainable management of the tree as part of our commitment to helping local communities both conserve their natural resources while also earning income for the basic needs of their families, such as food, clothing, health care and education. Jaguar employees have been collaborating with local communities, business partners and scientists for the past 30 years to make certain that the development and sale of this product provides benefit to local communities. Large numbers of these trees have been planted, and re-planted upon harvesting, across Peru in collaboration with communities and small local businesses.

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JAGUAR ANIMAL HEALTH

Jaguar Animal Health is an animal health company focused on creating plant-based gastrointestinal products for companion and production animals, foals, and high-value horses. Jaguar Animal Health is committed to discovering, developing, and commercializing plant-based prescription medicines and non-prescription products for animal health needs on a global basis. Each of our products are first-in-class and sustainably derived to ensure the highest degree of quality and ecological integrity.

Jaguar Animal Health continues to support the discovery and development of medicines from its proprietary library of 2,300 plants; presenting its four-legged patients with an increasing number of options for effective bio-based treatments.

Canalevia-CA1 is the lead prescription drug product for Jaguar Animal Health and is intended for the treatment of chemotherapy-induced diarrhea (CID) in dogs.

NEWS

Lisa Conte: Founder & CEO

Ms. Conte is the founder, president and chief executive officer, and a member of the board of directors, of Jaguar Health, a commercial-stage pharmaceuticals company committed to discovering, developing and commercializing plant-based prescription medicines for urgent global health needs. Mytesi®, the company’s FDA-approved drug product indicated for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy, is a first-in-class, plant-based anti-secretory agent and the first oral drug approved under FDA Botanical Guidance. In July 2017, two companies founded by Ms. Conte—Napo Pharmaceuticals, a human-focused pharmaceuticals company, and Jaguar Animal Health, the veterinary-focused licensor of all of Napo’s technology—merged and now comprise Jaguar Health. In 1989, Ms. Conte also founded Shaman Pharmaceuticals, Inc. and has pioneered plant-based prescription medicine investigation and development for more than 30 years, including a recent Entheogen Therapeutics Initiative, looking at psychoactive plants for novel cures for mood disorders and CNS neurodegenerative diseases. Ms. Conte is currently a member of the board of directors of Healing Forest Conservatory, and serves on the Editorial Advisory Board of Life Science Leader magazine. She holds an M.S. in Physiology and Pharmacology from the University of California, San Diego, and an M.B.A. and A.B. in Biochemistry from Dartmouth College.


Carol Lizak: Chief Financial Officer

Ms. Lizak is an accomplished, high-performing finance, operations, and strategic executive with more than twenty-five years of leadership experience in private and public life science and technology companies. Prior to serving as Jaguar’s CFO, she was the company’s Chief Accounting Officer. Before joining Jaguar, she served in executive director and corporate controller roles at Zosano Pharma Corp, Alexza Pharmaceuticals, Inc., LaserCard Corporation, and subsidiaries of HID Global, and in other senior finance leadership roles in both private and public companies. She holds an MBA from Pepperdine Graziadio Business School’s Executive MBA program.


Steven King, PhD: Chief Sustainable Supply, Ethnobotanical Research & IP Officer

Dr. King has served as our head of sustainable supply, ethnobotanical research and intellectual property since 2004. Prior to that, Dr. King served as the Vice President of Ethnobotany and Conservation at Shaman Pharmaceuticals, Inc. Dr. King has been recognized by the International Natural Products and Conservation Community for the creation and dissemination of research on the long-term sustainable harvest and management of Croton lechleri, the widespread source of crofelemer. Dr. King is currently a member of the board of directors of Healing Forest Conservatory, a California not-for-profit public benefit corporation. Dr. King holds an M.S. and Ph.D. in biology from the City University of New York (CUNY), and he received the first doctoral fellowship granted by the Institute of Economic Botany of the New York Botanical Garden.


Pravin Chaturvedi, PhD: Chief Scientific Officer; Chair of Scientific Advisory Board

Dr. Chaturvedi has served as our Chief Scientific Officer in addition to continuing his responsibilities as the Chair of the company’s Scientific Advisory Board (SAB) since March 1, 2022. He joined the Company in May 2017 as Chair of the SAB of Jaguar and Napo. Over his 30+ year career in the pharmaceutical industry, Dr. Chaturvedi has participated in the successful development and commercialization of multiple drugs in the therapeutic areas of epilepsy, HIV, hepatitis C, memory and gastrointestinal disorders. Dr. Chaturvedi served as the President and Chief Scientific Officer of Napo from 2006 to 2013 and remained a scientific adviser of Napo from 2013 through 2017. Dr. Chaturvedi has co-founded and led multiple biotech enterprises. From 2001 through 2004, he served as the President, Chief Executive Officer and Director of Scion Pharmaceuticals, Inc. He is the founder of IndUS Pharmaceuticals, where he has served as Chairman and Director since 2017, and held the same roles from 2005 through 2007 and from 2010 through 2015. IndUS Pharmaceuticals merged with Pivot Pharmaceuticals in 2015 and Dr. Chaturvedi served as the President and CEO of Pivot Pharmaceuticals from 2015 to 2017, prior to assuming his role as the Chair of the SAB for Napo and Jaguar. Dr. Chaturvedi also co-founded Oceanyx Pharmaceuticals, where he has served as Chief Executive Officer and Director since 2011, and he continues to serve on the boards of IndUS, Oceanyx, Enlivity and Cellanyx. He has been an adjunct faculty member at Georgetown University since 2013. Earlier in his career, from 1994 through 2001, Dr. Chaturvedi served in various roles as the head of lead evaluation at Vertex Pharmaceuticals, and from 1993 through 1994 he was in the preclinical group at Alkermes Inc. He started his career in the product development group at Parke-Davis/Warner-Lambert Company (now Pfizer) in 1988, where he worked through 1993. Dr. Chaturvedi holds a Ph.D. in Pharmaceutical Sciences from West Virginia University and a Bachelor’s in Pharmacy from the University of Bombay.


Darlene Horton, M.D.: Chief Medical Officer, Napo Pharmaceuticals

Dr. Horton brings 25 years of clinical research and development, medical affairs, senior executive, and consulting experience in the development of investigational and commercialized biopharmaceutical and drug-device combination products. She has extensive clinical development experience in multiple therapeutic areas including cardiology, oncology, immunology, orthopedics, gastroenterology, women’s health, and endocrinology. Prior to joining Napo, she led clinical development and regulatory strategy as CMO at Coherus Biosciences, Itero Biopharmaceuticals, and SMC Biotechnology. As Head of Clinical and Medical Affairs at Scios, she led the clinical development program that led to the approval of Natrecor® and was on the senior executive team when Scios was acquired by JNJ for $2.4B. At JNJ, she co-led (with strategic marketing) the cardiovascular therapeutic area when JNJ in-licensed and began developing the blockbuster drug Xarelto®. She also served as CEO at Nile Therapeutics and TulangCo Inc. Dr. Horton completed her Pediatric Cardiology fellowship and Pediatrics Residency at UCSF. She holds M.D. and B.S. in Microbiology degrees from the University of Florida.


David Sesin, PhD: Chief Manufacturing Officer

David is a pharmaceutical scientist with more than 30 years of experience ranging from drug discovery through manufacturing. He is the developer of the crofelemer manufacturing process. Prior to serving as Jaguar’s CMO, he was Director of Chemistry and QHSE at Bayer CropScience, Director of Chemistry at AgraQuest, Inc., and he spent nine years with Shaman Pharmaceuticals.


Jonathan Wolin, JD, MBA, CPA: Chief of Staff, Chief Compliance Officer & General Counsel

Mr. Wolin joined Jaguar’s team in November 2018. He brings more than 25 years of compliance, legal, and business experience with a number of life science, biotech and healthcare companies. Prior to joining Jaguar, Mr. Wolin was the Chief Administrative Officer for Pacific Pulmonary Services. He also served as the Chief Compliance Officer at other public and private companies, including Natera, Inc. Pacific Pulmonary Services, and Celera, Inc. Additionally, Mr. Wolin was General Counsel for Berkeley HeartLab, Inc. and a healthcare partner at the Mintz Levin law firm (Washington, DC). Jon has been part of leadership teams during three acquisitions, an IPO, and a turnaround. He is also certified in Healthcare Compliance and Healthcare Privacy Compliance.


Ian H. Wendt, MBA: Chief Commercial Officer

Prior to joining Jaguar, Mr. Wendt was at Gilead Sciences in a variety of field leadership and marketing roles in the HIV and hepatitis C therapeutic areas. Most recently, he led strategy and tactical development for a national team focused on policy and protocol development within key HIV treatment and prevention accounts, capacity building, and direct patient education. Mr. Wendt was also responsible for Gilead’s efforts to increase hepatitis C virus screening and treatment among non-specialist health care practitioners in support of Gilead’s market development efforts for a $10 billion brand franchise. Before Gilead, Mr. Wendt was at Boehringer Ingelheim, where he led HIV and oncology sales teams across the US, and led commercial operations at Roxane Laboratories, which included sales operations, analytics, incentive compensation, and training. He received a BSc from Acadia University and an MBA from Dalhousie University in Nova Scotia.


Karen Brunke, PhD: Executive Vice President, Corporate & Business Development

Dr. Brunke brings to Jaguar over 30 years of scientific, operational, clinical, senior executive, and corporate development experience in both large and small biotechnology companies. Following her post-doctoral fellowship at the Institute for Cancer Research in Fox Chase, Dr. Brunke joined the seeds division of Sandoz, with her most recent position having been Research Director, overseeing a department whose successes included recombinant insect-resistant plants (GMOs) which have been an important backbone for the greater than $3 billion seed business of the now Syngenta Seeds. She was next part of the executive team that merged Mercator Genetics with Progenitor and helped take the resultant company public. Dr. Brunke was COO of Anexus Pharmaceuticals, a subsidiary of the Japanese public company MediBic, responsible for in- and out-licensing assistance for Japanese companies, and was next founding CEO of Cardeus Pharmaceuticals, a neuroscience company. In business and corporate development, Dr. Brunke has had primary responsibility for negotiating multiple partnerships and licenses, including with MedImmune and Astellas, and assisted in closing a deal with GlaxoSmithKline, among others. Dr. Brunke received her BA degree in Biochemistry as well as PhD in Microbiology from the University of Pennsylvania.


Brian Sutton: National Business Director

Mr. Sutton previously served as western regional business director for Napo. Prior to joining Napo, he was an executive cardiovascular hospital account manager with Novartis, an executive institutional business manager with Bristol-Myers Squib in HIV, and an institutional diabetes account Manager with Novo Nordisk A/S, and held roles with Shire, Johnson & Johnson and other companies in the pharmaceutical and medical device industries. He has a B.S. in Marketing from Penn State University and an M.S. in Information Systems Engineering from the CHUBB Institute.


Michael K. Guy, DVM, MS, PhD: Vice President, Preclinical & Nonclinical Studies

‘Dr. Mike’ joined Jaguar in September 2015 with over 20 years of experience in animal and human pharmaceutical development. Dr. Guy has worked in clinical development, manufacturing, regulatory and pre-clinical drug discovery, and he has worked at Amgen, Heska, Colorado Serum Company, Lloyd Pharmaceuticals, Virbac Animal Health, and most recently, the Morris Animal Foundation, where he created and recruited the largest and longest clinical trial ever done in dogs – the 3,000 dog Golden Retriever Lifetime Study. In addition, Dr. Mike has over 12 years of experience as a practicing veterinarian, and his patients have included everything from dogs, cats, horses and ferrets to birds, wildlife and zoo animals. Dr. Guy still maintains his veterinary license and volunteers as a spay/neuter surgeon at a local animal shelter. At Jaguar, Dr. Mike supervises all animal health clinical studies, is involved in regulatory, safety assessment and manufacturing, and he advises on the many other scientific and medical activities within the company.


Sincerely,

The Viral Stocks Team

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