JAGX Jaguar Health Inc.

1.67
-0.03  -2%
Previous Close 1.7
Open 1.69
52 Week Low 0.185
52 Week High 4.47
Market Cap $229,324,871
Shares 137,320,282
Float 137,122,331
Enterprise Value $215,869,858
Volume 4,904,429
Av. Daily Volume 12,847,381
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Crofelemer (Mytesi)
Chronic Idiopathic Diarrhea in Non-HIV Patients
Phase 3
Phase 3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
Mytesi (crofelemer) HALT-D
Cancer related diarrhea (CRD)
Phase 2
Phase 2
Phase 2 trial ongoing.
Mytesi (crofelemer)
Cancer Therapy-Related Diarrhea
Phase 3
Phase 3
Phase 3 trial initiation announced October 7, 2020.
Mytesi (crofelemer)
Inflammatory bowel disease (IBD)
Phase 2
Phase 2
Protocol development for discussions with FDA.

Latest News

  1. Based on a preliminary review of votes cast, over 76% have voted in favor of Proposals 2, 3, 4 & 6
    Meeting scheduled to reconvene July 9, 2021 at 8:30 AM Pacific Standard Time to provide time to reach quorum

    SAN FRANSICO, CA / ACCESSWIRE / June 11, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) ('Jaguar' or the 'Company') today announced that it has adjourned its Annual Meeting of Stockholders held on May 13, 2021 (the "Annual Meeting") for a second time due to a lack of quorum. The adjourned meeting will be held at 8:30 a.m. Pacific Standard Time/11:30 a.m. Eastern Standard Time on Friday, July 9, 2021, at the offices of the Company at 200 Pine Street, Suite 400, San Francisco, CA 94104. The record date for determining stockholders eligible to vote…

    Based on a preliminary review of votes cast, over 76% have voted in favor of Proposals 2, 3, 4 & 6
    Meeting scheduled to reconvene July 9, 2021 at 8:30 AM Pacific Standard Time to provide time to reach quorum

    SAN FRANSICO, CA / ACCESSWIRE / June 11, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) ('Jaguar' or the 'Company') today announced that it has adjourned its Annual Meeting of Stockholders held on May 13, 2021 (the "Annual Meeting") for a second time due to a lack of quorum. The adjourned meeting will be held at 8:30 a.m. Pacific Standard Time/11:30 a.m. Eastern Standard Time on Friday, July 9, 2021, at the offices of the Company at 200 Pine Street, Suite 400, San Francisco, CA 94104. The record date for determining stockholders eligible to vote at the Annual Meeting will remain the close of business on April 12, 2021. Stockholders have thus far strongly supported the proposals.

    No action is required by any stockholder who has previously delivered a proxy and who does not wish to revoke or change that proxy.

    "We currently have less than 0.1% of our total authorized shares of Common Stock available for future issuance, taking into account shares issued and outstanding and shares reserved for issuance upon exercise of outstanding warrants, existing equity incentive awards, and under our stock incentive plan and inducement award plans. The Board believes that approval of Proposal 3 - the proposed increase in the number of authorized shares of Common Stock - will benefit us by providing flexibility in responding to future business opportunities as the Board may deem in the best interest of shareholders, from time to time; and also, if deemed in the best interest of shareholders by the Board, to raise additional capital from time to time to execute our business plans," said Lisa Conte, Jaguar's president and CEO.

    "We encourage all eligible stockholders who have not yet voted their shares - or provided voting instructions to their broker or other record holder - to do so prior to the Annual Meeting, as your participation is important. See below under ‘How to Vote' for instructions on how to vote if you have not already voted, or if you would like to change your votes," said Conte. "Jaguar's Board of Directors recommends a vote 'FOR' the presented proposals. Based on a preliminary review of the votes cast, over 76% have voted in favor of Proposal 3 ("Approving an amendment to the Company's Third Amended and Restated Certificate of Incorporation, as amended (the "COI"), to increase the number of authorized shares of Common Stock from 150,000,000 shares to 290,000,000 shares."). Approximately an additional 6% of the Company's eligible common stock outstanding needs to be voted to reach quorum."

    How to Vote

    Stockholders of record as of the close of business on April 12, 2021 may vote by internet at http://www.voteproxy.com, or by telephone at 800-776-9437 (this voting phone number is operational 24x7), or by returning a properly executed proxy card. Stockholders who hold shares of Jaguar stock in street name may vote through their broker. Street name stockholders requiring assistance with voting their shares are encouraged to contact Jaguar's proxy solicitation firm, Georgeson, at 866-821-0284, Monday to Friday from 9:00 AM - 11:00 PM US Eastern Standard Time, and Saturday from 12:00 PM-6:00 PM US Eastern Standard Time. Georgeson's call center is not staffed on Sundays.

    No changes have been made to the proposals to be voted on by stockholders at the Annual Meeting. The Company's Proxy Statement and any other materials filed by the Company with the SEC can be obtained free of charge at the SEC's website at www.sec.gov.

    About Jaguar Health, Inc., Napo Pharmaceuticals, Inc. & Napo EU S.p.A.

    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. Our wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest areas. Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance. Napo Pharmaceuticals' wholly owned Italian subsidiary, Napo EU S.p.A., focuses on expanding crofelemer access in Europe.

    For more information about Jaguar, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com. For more information about Napo EU, visit www.napoeu.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%).

    More information and complete Prescribing Information are available 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.

    Forward-Looking Statements

    Certain statements in this press release constitute "forward-looking statements." These include statements regarding the Company's belief that approval of Proposal 3 will benefit the Company by providing flexibility in responding to future business opportunities as the Board may deem in the best interest of shareholders, from time to time; and also, if deemed in the best interest of shareholders by the Board, to raise additional capital from time to time to execute the Company's business plans. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    CONTACT:
    Peter Hodge
    Jaguar Health, Inc.

    Jaguar-JAGX

    SOURCE: Jaguar Health, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/651327/Jaguar-Health-Announces-Adjournment-of-Annual-Meeting-of-Stockholders-Until-Friday-July-9-2021-and-Encourages-All-Shareholders-to-Vote

    View Full Article Hide Full Article
  2. Registration link for webcast appears below

    SAN FRANCISCO, CA / ACCESSWIRE / June 2, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") issued a reminder today that an Innovators with Jane King webcast interview with Jaguar CEO Lisa Conte & Dragon SPAC S.p.A. ("Dragon SPAC") founding sponsor Josh Mailman will air this Thursday, June 3, 2021, at 8:30 AM Eastern Time.

    The interview will focus on plans, announced June 1, 2021, for Napo EU S.p.A., the Italian subsidiary of Napo Pharmaceuticals, Jaguar's wholly owned U.S. subsidiary, to pursue conditional marketing authorization from the European Medicines Agency for crofelemer, the Company's novel proprietary drug, for an important orphan indication: short bowel syndrome ("SBS…

    Registration link for webcast appears below

    SAN FRANCISCO, CA / ACCESSWIRE / June 2, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") issued a reminder today that an Innovators with Jane King webcast interview with Jaguar CEO Lisa Conte & Dragon SPAC S.p.A. ("Dragon SPAC") founding sponsor Josh Mailman will air this Thursday, June 3, 2021, at 8:30 AM Eastern Time.

    The interview will focus on plans, announced June 1, 2021, for Napo EU S.p.A., the Italian subsidiary of Napo Pharmaceuticals, Jaguar's wholly owned U.S. subsidiary, to pursue conditional marketing authorization from the European Medicines Agency for crofelemer, the Company's novel proprietary drug, for an important orphan indication: short bowel syndrome ("SBS"). SBS is a complex condition characterized by severe malabsorption of fluids and nutrients due to surgical resection of substantial lengths of bowel segments, congenital anomalies, or disease-associated loss of absorption.

    Participation Instructions for Webcast

    When: Thursday, June 3rd at 8:30 AM Eastern Time

    Participant Registration & Access Link: Click Here

    Napo EU S.p.A. is the named target of Italy-based Dragon SPAC.

    About Jaguar Health, Inc., Napo Pharmaceuticals, Inc. & Napo EU S.p.A.
    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. Our wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest areas. Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance. Napo Pharmaceuticals' wholly owned Italian subsidiary, Napo EU S.p.A., focuses on expanding crofelemer access in Europe.

    For more information about Jaguar, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com. For more information about Napo EU, visit www.napoeu.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%).

    More information and complete Prescribing Information are available 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.

    Forward-Looking Statements
    Certain statements in this press release constitute "forward-looking statements." These include statements regarding the Company's expectation that a webcast interview event will take place June 3, 2021. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Source: Jaguar Health, Inc.

    Contact:
    Peter Hodge
    Jaguar Health, Inc.

    Jaguar-JAGX

    SOURCE: Jaguar Health, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/650012/REMINDER-Innovators-with-Jane-King-Webcast-Interview-with-Jaguar-Health-CEO-Lisa-Conte-Dragon-SPAC-Founding-Sponsor-Josh-Mailman-to-Take-Place-Thursday-June-3-2021-at-830-AM-Eastern

    View Full Article Hide Full Article
  3. Jaguar & Dragon SPAC announce initial funding of $10.8 million into Dragon SPAC

    Napo EU to focus initially on conditional approval for an important orphan indication, short bowel syndrome (SBS), a condition leading to intestinal failure

    Innovators with Jane King webcast interview with Jaguar CEO Lisa Conte & Dragon SPAC founding sponsor Josh Mailman to take place Thursday, June 3rd at 8:30 AM Eastern

    Registration link for webcast appears below

    Equita Group S.p.A., a leading Italian based investment bank, advising Dragon SPAC; Cantor Fitzgerald & Co. advising Jaguar on non-deal related activities

    SAN FRANCISCO, CA & MILAN, ITALY / ACCESSWIRE / June 1, 2021 / Napo EU S.p.A. ("Napo EU"), the Italian subsidiary of Napo Pharmacuticals, Inc. ("Napo Pharma…

    Jaguar & Dragon SPAC announce initial funding of $10.8 million into Dragon SPAC

    Napo EU to focus initially on conditional approval for an important orphan indication, short bowel syndrome (SBS), a condition leading to intestinal failure

    Innovators with Jane King webcast interview with Jaguar CEO Lisa Conte & Dragon SPAC founding sponsor Josh Mailman to take place Thursday, June 3rd at 8:30 AM Eastern

    Registration link for webcast appears below

    Equita Group S.p.A., a leading Italian based investment bank, advising Dragon SPAC; Cantor Fitzgerald & Co. advising Jaguar on non-deal related activities

    SAN FRANCISCO, CA & MILAN, ITALY / ACCESSWIRE / June 1, 2021 / Napo EU S.p.A. ("Napo EU"), the Italian subsidiary of Napo Pharmacuticals, Inc. ("Napo Pharma"), which is a wholly owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company"), today provided updates on plans to pursue conditional marketing authorization from the European Medicines Agency ("EMA") for crofelemer, the Company's novel proprietary drug. Additionally, Jaguar and Milan, Italy-based Dragon SPAC S.p.A. ("Dragon SPAC") today announced the first funding of the Dragon SPAC private financing in an amount equal to approximately $10.8 million, with proceeds of such financing to be used in part for Dragon SPAC's contemplated business combination with Napo EU.

    Napo EU was formed with the mission to expand access to crofelemer to Europe to address significant unmet gastrointestinal medical needs, and Napo EU's initial focus is on pursuing conditional marketing authorization for an important orphan indication: short bowel syndrome ("SBS"). SBS is a complex condition characterized by severe malabsorption of fluids and nutrients due to surgical resection of substantial lengths of bowel segments, congenital anomalies, or disease-associated loss of absorption.

    In the European Union (EU), a drug is defined as rare/orphan if it treats a life-threatening or chronically and seriously debilitating condition affecting fewer than 5 in 10,000 people across the EU. An orphan designation allows a pharmaceutical company to benefit from incentives from the EU, such as reduced fees and protection from competition once the medicine is placed on the market.

    Napo Pharma previously received orphan‑drug status for crofelemer from the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration ("FDA") for a potential future SBS indication in adult and/or pediatric patients. Napo Pharma intends to simultaneously pursue regulatory approval to commercialize the new formulation of crofelemer in the U.S. for SBS.

    The FDA is committed to advancing rare disease therapies through the Orphan Drug Act (ODA) of 1983, providing financial and other incentives for innovation to treat rare diseases. Since this groundbreaking legislation went into effect, more than 300 orphan products for treatment of rare diseases have been approved in the U.S. by the FDA.

    "For SBS patients who suffer from the catastrophic loss of their bowel, the resulting excessive intestinal fluid output and lifelong restriction and adjustment of oral intake of food and liquids leads to the requirement that patients receive intravenous fluids for most of every day - a treatment called parenteral support ("PS"). This challenges their ability to carry out activities of daily living, or to attend school or work, and has a significant impact on their daily quality of life. Furthermore, lifelong PS leads to potentially life-threatening complications like sepsis," Darlene Horton, M.D., Napo's Chief Medical Officer, said. "Orphan drug designation is one of the most important areas of drug regulatory incentives that exists today."

    According to the Crohn's & Colitis Foundation, approximately 10,000 to 20,000 people in the United States have SBS1, and it's estimated that the population of SBS patients in Europe is approximately the same size.2 Many of these patients are reliant on parenteral support.

    It is estimated that the direct costs of inpatient PS in Europe ranges from approximately €28,000 to €75,000 (approximately $34,000 to $91,000 per patient per year3-5) and that home parenteral nutrition costs 30%-60% less than the cost of PS in the hospital6. The estimated annual cost for non-hospitalized PS for an SBS patient in the U.S. is approximately $150,0007. Additional indirect PS costs include hospitalisations, infections, laboratory tests, and the need for a multi-disciplinary care team which can further increase health care resource utilization.

    A treatment that can delay or reduce an SBS patient's reliance on PS will offer significant value to the patient in terms of disease management and quality of life and offer significant cost savings to the healthcare system. The global SBS market exceeded $568 million in 2019 and is expected to reach $4.6 billion by 2027 with a CAGR of 26% from 2020 to 2027, according to a report from Vision Research Reports.

    "We are quite pleased that Napo EU is the named target of Dragon SPAC and that Dragon SPAC has completed a first funding for the benefit of Napo EU," stated Lisa Conte, Napo EU's sole board member and the founder, president, and CEO of Jaguar and Napo Pharma. "Napo EU has refined its business plan, and the terms of its contemplated license from Napo Pharma, to focus initially on conditional approval for SBS. Although our initial focus was on addressing diarrhea in COVID long-hauler patients, there is growing evidence that long-hauler symptoms may be ameliorated following vaccination against COVID-19. While Napo EU will continue to monitor the COVID long-hauler population to determine if diarrhea remains a chronic condition, we believe focusing on SBS represents a more substantial and long-term initial opportunity for Napo EU to help patients with significant unmet medical needs. Plans are in place to develop a new dosage form of crofelemer that will be optimized for SBS patients and would, we believe, be eligible to pursue the EMA's conditional marketing authorization pathway for orphan medicines for this indication."

    Participation Instructions for Webcast

    When: Thursday, June 3rd at 8:30 AM Eastern Time

    Participant Registration & Access Link: Click Here

    About Jaguar Health, Inc., Napo Pharmaceuticals, Inc. & Napo EU S.p.A.

    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. Our wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest areas. Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance. Napo Pharmaceuticals' wholly owned Italian subsidiary, Napo EU S.p.A., focuses on expanding crofelemer access in Europe.

    For more information about Jaguar, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com. For more information about Napo EU, visit www.napoeu.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%).

    More information and complete Prescribing Information are available 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.

    Forward-Looking Statements

    Certain statements in this press release constitute "forward-looking statements." These include statements regarding Napo EU's plans to pursue conditional marketing authorization for SBS, Napo Pharma's intention to pursue regulatory approval to commercialize a new formulation of crofelemer in the U.S. for SBS, the Company's belief that focusing on SBS represents a more substantial and long-term initial opportunity for Napo EU to help patients with significant unmet medical needs, plans to develop a new dosage form of crofelemer that will be optimized for SBS patients, the belief that the new dosage form of crofelemer will be eligible to pursue the EMA's conditional marketing authorization pathway for orphan medicines for this indication, and the Company's expectation that a webcast interview event will take place June 3, 2021. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    1http://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/short-bowel-disease-crohns.pdf

    2http://www.pharmabiz.com/NewsDetails.aspx?aid=84221&sid=2

    3Aatmani TDK, et al. Gastroenterol Clin Biol 2006;30:574-79

    4Arhip L, et al. Clin Nutr. 2019;38(4):1945-51

    5Howard L. Gastroenterology. 2006;130(2 Suppl 1):S52-9

    6https://int.shortbowelsupport.com/hcp/burden-of-disease/costs-of-sbs-if-care

    7https://nutritionequity.org/wp-content/uploads/2018/05/mnea-factsheet-sbs.pdf

    Jaguar Contact:
    Peter Hodge
    Jaguar Health, Inc.

    Jaguar-JAGX

    SOURCE: Jaguar Health, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/649860/Napo-EU-SpA-Jaguar-Healths-Italian-Subsidiary-Provides-Updates-on-Plans-to-Pursue-Conditional-Marketing-Authorization-in-the-EU

    View Full Article Hide Full Article
  4. Napo EU S.p.A., named target of Dragon SPAC, provides update on plan to pursue conditional marketing authorization for crofelemer in EU

    Equita Group S.p.A., a leading Italian based investment bank, advising Dragon SPAC; Cantor Fitzgerald & Co. advising Jaguar on non-deal related activities

    SAN FRANCISCO, CA & MILAN, ITALY / ACCESSWIRE / June 1, 2021 / Jaguar Health, Inc. ("Jaguar") and Milan, Italy-based Dragon SPAC S.p.A. ("Dragon SPAC") today announced the initial funding of the private financing of Dragon SPAC, which has named as its target Napo EU S.p.A. ("Napo EU"). Dragon SPAC and Napo Pharmaceuticals, Inc. ("Napo Pharma"), Jaguar's wholly-owned U.S. subsidiary, have entered into an agreement, pursuant to which Dragon SPAC will issue units…

    Napo EU S.p.A., named target of Dragon SPAC, provides update on plan to pursue conditional marketing authorization for crofelemer in EU

    Equita Group S.p.A., a leading Italian based investment bank, advising Dragon SPAC; Cantor Fitzgerald & Co. advising Jaguar on non-deal related activities

    SAN FRANCISCO, CA & MILAN, ITALY / ACCESSWIRE / June 1, 2021 / Jaguar Health, Inc. ("Jaguar") and Milan, Italy-based Dragon SPAC S.p.A. ("Dragon SPAC") today announced the initial funding of the private financing of Dragon SPAC, which has named as its target Napo EU S.p.A. ("Napo EU"). Dragon SPAC and Napo Pharmaceuticals, Inc. ("Napo Pharma"), Jaguar's wholly-owned U.S. subsidiary, have entered into an agreement, pursuant to which Dragon SPAC will issue units ("Units") to Napo Pharma in a private placement for cash consideration of approximately US$10.8 million, with proceeds of such financing to be used in part for Dragon SPAC's contemplated business combination (the "Merger") with Napo EU. Each Unit consists of one ordinary share of Dragon SPAC and one warrant. Each warrant will entitle the holder thereof to purchase one ordinary share at an exercise price of EUR 10 per ordinary share at any time prior to the earlier of (i) the 10-year anniversary of the consummation of the Merger and (ii) the five-year anniversary of the listing of the combined Napo EU/Dragon SPAC entity resulting from the Merger (the "Combined Company") on a public exchange. The private financing is expected to close around the end of Q2 2021, subject to certain conditions including the concurrent closing of the Merger and completion of customary items.

    Proceeds from the private placement will be used exclusively for the purposes of funding the Merger and the activities of the Combined Company.

    As announced today, Napo EU, the wholly-owned Italian subsidiary of Napo Pharma, has refined its business plan, and terms of its contemplated license from Napo Pharma, to focus initially on conditional approval for an important orphan indication, short bowel syndrome (SBS), a condition leading to intestinal failure requiring intravenous nutritional support for survival, and a global market expected to reach US$4.6 billon by 2027, expanding at a CAGR of 26% from 2020 to 20271, rather than the previously announced indication of prophylaxis and/or symptomatic relief of inflammatory diarrhea, including COVID-associated diarrhea.

    "We're thrilled to provide the initial funding of US$10.8 million into Dragon SPAC using funds from the recent registered direct offering - which closed on May 3, 2021 - by Jaguar to certain North American institutional investors into Jaguar," stated Lisa Conte, Napo EU's sole board member and the founder, president, and CEO of Jaguar and Napo Pharma. "As Jaguar announced on April 29, 2021, the proceeds from the registered direct offering were earmarked for the benefit of our Italian subsidiary Napo EU - the named target of Dragon SPAC," Conte said.

    "With the recent choppiness and uncertain liquidity in the U.S. and European SPAC markets, Dragon SPAC has been advised by its banking advisors to hold off on a public financing at this time. Plans for the Napo EU drug development opportunity are progressing, and Dragon SPAC has decided to complete a private financing rather than a public financing to fund the Merger," said Josh Mailman, the founding sponsor and a board member of Dragon SPAC. "With this first investment funded and the initial product development focus on the devastating unmet medical need in patients suffering from SBS, Dragon SPAC remains confident about receiving binding commitments for this private financing from additional investors, with closing of the private financing targeted to occur around the end of Q2 2021, and the closing of the planned Merger to occur within approximately 30 days thereafter. The business of the Combined Company will be the Napo EU business, with funds that we believe will be sufficient to complete a trial in SBS patients suitable for a conditional marketing authorization pathway with the EMA."

    With an eye toward a potential future listing of the Combined Company following receipt of results of data from a clinical trial which the Combined Company expects to receive within two years of the completion of the Merger transaction, Dragon SPAC has engaged Equita Group S.p.A., a leading Italian independent investment bank, to advise Dragon SPAC, and Jaguar has engaged New York-based Cantor Fitzgerald & Co., a leading global financial services group, as a capital markets advisor in the U.S. to assist Jaguar in its evaluation of various financing strategies.

    Additional Dragon SPAC board members include Dr. Niccolò Caderni and Giovanni Maria Conti, who is of no relation to Lisa Conte.

    An astrophysicist by training, Dr. Caderni is a former European Space Agency Fellow at the University of Cambridge. He held a number of research and academic positions before a change of career in the mid 1980's to the fields of finance, technological innovation, and fine art. He previously served as vice president, mergers and acquisitions at Bankers Trust International, managing director at Phillips, the third largest auction house in the world, the chairman of Webiz, the private equity fund of the Italian utility giant, ENEL, the Chairman of RAFT, a leading research institute in the field of regenerative medicine, and served on the Board of the Centre for European Policy Studies in Brussels.

    Giovanni Maria Conti is a founding partner of CPAssociati, a chartered accountant's professional firm in Italy, and has extensive experience providing advisory services to national and international companies in the areas of corporate governance, finance transactions, M&A operations, and tax. He is a former founding partner of RSC & Partners S.r.l., which is an advisory firm, now named Oryx Finance S.r.I., that specializes in IPO processes, M&A, debt advisory, and financial restructuring. In 2003 he participated in drafting the Italian government law to reform the country's tax system. Mr. Conti has been listed on the National Register of Certified Public Accountants of Milan since 1994, and on the Register of Auditors since 1999.

    Dragon SPAC is selling its Units and underlying ordinary shares and warrants (collectively, the "Securities") only to "accredited investors" in reliance on the exemption from registration set forth in Rule 506(c) of Regulation D promulgated under the Securities Act of 1933, as amended (the "Securities Act"). The Securities, have not been and will not be registered under the Securities Act or the securities laws of any state or other jurisdiction, and may not be offered or sold without registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities or blue sky laws and foreign securities laws.

    This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor shall there be any sales of the Securities in any jurisdiction in which such offer, solicitation or sales would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

    About Jaguar Health, Inc., Napo Pharmaceuticals, Inc. & Napo EU S.p.A.

    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. Our wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest areas. Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance. Napo Pharmaceuticals's wholly owned Italian subsidiary, Napo EU S.p.A., focuses on expanding crofelemer access in Europe.

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

    Forward-Looking Statements

    Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that the private financing will close around the end of Q2 2021, subject to certain conditions including the concurrent closing of the Merger and completion of customary items, the expectation that the global SBS market will reach US$4.6 billon by 2027, expanding at a CAGR of 26% from 2020 to 2027, Dragon SPAC's expectation that it will receive binding commitments for the private financing from additional investors, Dragon SPAC's expectation that closing of the private financing will occur around the end of Q2 2021 and Dragon SPAC's expectation that the closing of the planned Merger will occur within approximately 30 days thereafter, Dragon SPAC's expectation that the Combined Company will have sufficient funds to complete a trial in SBS patients suitable for a conditional marketing authorization pathway with the EMA, and the expectation that data from a clinical trial will be available within two years of the completion of the Merger transaction. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    1https://www.mynewsdesk.com/us/medical-technology-news/pressreleases/short-bowel-syndrome-market-global-industry-analysis-size-share-trends-revenue-forecast-2020-to-2027-3069433

    Source: Jaguar Health, Inc. and Dragon SPAC

    Jaguar Contact:

    Peter Hodge
    Jaguar Health, Inc.

    Dragon SPAC Contact:
    Josh Mailman

    Jaguar-JAGX

    SOURCE: Jaguar Health, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/649859/Jaguar-Health-Dragon-SPAC-Announce-Initial-Funding-of-US108-Million-into-Dragon-SPAC

    View Full Article Hide Full Article
  5. SAN FRANCISCO, CA / ACCESSWIRE / May 26, 2021 / Napo Pharmaceuticals Inc., the wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company"), announced today the appointment of Darlene Horton, M.D., a biopharmaceutical veteran and leading clinical development expert, to the role of Chief Medical Officer (CMO) for Napo.

    "We are thrilled that Darlene is bringing her strong clinical experience together with deep industry experience and operational leadership, which will support Napo's ongoing phase 3 clinical trial with crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted cancer therapy ("cancer therapy‑related diarrhea" (CTD))," said Pravin Chaturvedi, PhD, Napo/Jaguar Chair, Scientific Advisory…

    SAN FRANCISCO, CA / ACCESSWIRE / May 26, 2021 / Napo Pharmaceuticals Inc., the wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company"), announced today the appointment of Darlene Horton, M.D., a biopharmaceutical veteran and leading clinical development expert, to the role of Chief Medical Officer (CMO) for Napo.

    "We are thrilled that Darlene is bringing her strong clinical experience together with deep industry experience and operational leadership, which will support Napo's ongoing phase 3 clinical trial with crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted cancer therapy ("cancer therapy‑related diarrhea" (CTD))," said Pravin Chaturvedi, PhD, Napo/Jaguar Chair, Scientific Advisory Board and acting Chief Scientific Officer. "Darlene has a deep background in drug development, and her leadership and stewardship will augment our ongoing clinical studies for CTD as well as other planned indications."

    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.

    "I am very excited to join Napo at this important time, when both our lead CTD program and efforts to pursue conditional marketing authorization from the European Medicines Agency for crofelemer through Napo EU are underway," said Dr. Horton. "I believe crofelemer's novel mechanism of action has the potential to benefit multiple gastrointestinal disorders. I am delighted to be partnering with the experienced Napo and Jaguar leadership teams and look forward to helping the Company expand access to crofelemer."

    Mytesi (crofelemer) is a non-opiate, plant-based, chloride ion channel modulating antidiarrheal medicine that is FDA approved for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS receiving antiretroviral therapy. The only oral plant-based prescription medicine approved under FDA Botanical Guidance, Mytesi has a novel mechanism of action that works locally in the gut by gently and effectively modulating and normalizing the flow of water and electrolytes with minimal systemic absorption.

    About Jaguar Health, Inc. and Napo Pharmaceuticals, Inc.
    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. Our wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest areas. Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance.

    For more information about Jaguar, please visit https://jaguar.health. For more information about Napo, 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%).

    More information and complete Prescribing Information are available 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.

    Forward-Looking Statements
    Certain statements in this press release constitute "forward-looking statements." These include statements regarding the belief that Dr. Horton's leadership and stewardship will augment Napo's ongoing clinical studies for CTD as well as other planned indications, and the belief that crofelemer's novel mechanism of action has the potential to benefit multiple gastrointestinal disorders. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    CONTACT:
    Peter Hodge
    Jaguar Health, Inc.

    Jaguar-JAGX

    SOURCE: Jaguar Health, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/649120/Napo-Pharmaceuticals-Jaguar-Healths-Subsidiary-Bolsters-Management-Team-with-Appointment-of-Darlene-Horton-MD-as-Chief-Medical-Officer

    View Full Article Hide Full Article
View All Jaguar Health Inc. News