PHAT Phathom Pharmaceuticals Inc.

32.1
+0.13  (+0%)
Previous Close 31.97
Open 31.76
52 Week Low 30.465
52 Week High 50.78
Market Cap $1,005,680,577
Shares 31,329,613
Float 20,536,258
Enterprise Value $812,929,727
Volume 81,788
Av. Daily Volume 98,821
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Upcoming Catalysts

Drug Stage Catalyst Date
Vonoprazan PHALCON-HP
H. pylori
NDA Filing
NDA Filing
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Vonoprazan PHALCON-EE
Erosive esophagitis / Gastroesophageal reflux disease (GERD)
Phase 3
Phase 3
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Vonoprazan (PHALCON-NERD)
Non-erosive reflux disease (NERD)
Phase 2
Phase 2
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Latest News

  1. Eleusis, a clinical-stage life science company dedicated to unlocking the full therapeutic potential of psychedelics, today announced the appointment of four highly experienced business leaders to its board of directors. The new directors' deep expertise building high-growth, high-impact life science companies complements Eleusis's world-class leadership team. The appointees include:

    • David Socks, former CEO of Phathom Pharmaceuticals, joining as Chair of the board
    • Robert Hershberg, M.D., Ph.D., former CBO and CSO of Celgene
    • John Tucker, CEO of SC Pharmaceuticals
    • Esther van den Boom, Managing Partner at van den Boom & Associates

    "We are delighted to welcome these four exceptional directors, who bring with them decades of experience…

    Eleusis, a clinical-stage life science company dedicated to unlocking the full therapeutic potential of psychedelics, today announced the appointment of four highly experienced business leaders to its board of directors. The new directors' deep expertise building high-growth, high-impact life science companies complements Eleusis's world-class leadership team. The appointees include:

    • David Socks, former CEO of Phathom Pharmaceuticals, joining as Chair of the board
    • Robert Hershberg, M.D., Ph.D., former CBO and CSO of Celgene
    • John Tucker, CEO of SC Pharmaceuticals
    • Esther van den Boom, Managing Partner at van den Boom & Associates

    "We are delighted to welcome these four exceptional directors, who bring with them decades of experience building successful therapeutics-focused life sciences companies," said Shlomi Raz, Eleusis's CEO and founder. "Our management team is thrilled to have these individuals help support and guide the company's effort to discover, develop, and deliver transformational psychedelic drug therapies to patients in urgent need of new treatment alternatives."

    "This is an opportune moment for Eleusis to push forward its vision of transforming psychedelics into modern medicines," said David Socks, Chair of the board. "On behalf of myself and my fellow directors, we are excited to be involved in a science-driven company that is pursuing a disciplined, thoughtful approach to transforming psychedelics into potential treatment options for patients with depression and other neuropsychiatric disorders, where there is significant unmet need."

    ELE-Psilo, the company's lead psychedelic drug candidate, is based on a proprietary, infusible form of psilocybin and is expected to enter clinical trials in early 2022. The company is also in the process of nationally scaling its innovative care delivery platform for psychedelic drug therapy to provide patients with affordable therapeutic alternatives for depression in a safe and caring environment.

    Board Appointments

    David Socks currently serves on the board of directors of Phathom Pharmaceuticals (NASDAQ:PHAT), where he was the founding CEO through the company's IPO. He also serves as a Venture Partner at Frazier Healthcare Partners, where he helps lead the firm's company creation efforts, co-founding companies such as Arcutis (NASDAQ:ARQT), Passage Bio (NASDAQ:PASG) and Scout Bio. Mr. Socks has also served as an advisor to Prometheus Bioscience (NASDAQ:RXDX) and PvP Biologics (acquired by Takeda). Previously, he was co-founder, President and COO of Incline Therapeutics (acquired by the Medicines Company) and co-founder and Senior Vice President, Corporate Development and Strategy of Cadence Pharmaceuticals (NASDAQ:CADX, acquired by Mallinckrodt))). Mr. Socks holds a B.S. from Georgetown University and an M.B.A from Stanford University.

    Robert Hershberg, M.D., Ph.D., is a Venture Partner on the life sciences team at Frazier Healthcare Partners. Dr. Hershberg previously served as President and Chief Executive Officer of VentiRx Pharmaceuticals, a Frazier-founded company that he led through its transformational partnership with Celgene. Mr. Hershberg then joined Celgene, where he was promoted to Chief Scientific Officer and subsequently to Chief Business Officer. Before VentiRx, he served as Senior Vice President and Chief Medical Officer of Dendreon Corporation and as Vice President of Medical Genetics at Corixa, a Frazier portfolio company. Earlier in his career, he was an Assistant Professor at Harvard Medical School and an Associate Physician at Brigham and Women's Hospital in Boston. Dr. Hershberg received his undergraduate and medical degrees from the University of California, Los Angeles, and his Ph.D. from the Salk Institute for Biological Studies.

    John H. Tucker is the Chief Executive Officer of scPharmaceuticals. Mr. Tucker previously served as Chief Executive Officer at Algal Scientific and Alcresta, where he led both companies through successful periods of strategic innovation and development. Throughout his career, he has held senior positions at multiple life sciences companies, including Incline Therapeutics, AMAG Pharmaceuticals, Basilea Pharmaceuticals and Indevus Pharmaceuticals. He also worked in a variety of hospital and retail-based sales and marketing roles at Ortho-McNeil Pharmaceuticals, ALZA Corporation, VIVUS and UCB Pharma. Mr. Tucker holds a B.A. from Plymouth State College and an M.B.A. from New Hampshire College.

    Esther van den Boom is Managing Partner of van den Boom & Associates and Chief Financial Officer of Tyra Biosciences. Ms. van den Boom has personally worked with over 50 life sciences companies throughout her career, partnering on various responsibilities including CFO, SOX 404 implementations, compliance and IPO assistance. Prior to founding van den Boom & Associates, she worked at Ernst & Young LLP as a Senior Manager in their San Diego office's audit practice. Ms. van den Boom received a B.A. in economics from the University of California, San Diego and an M.S. in accountancy from San Diego State University and is a licensed CPA.

    About Eleusis Ltd.

    Founded in 2013, Eleusis is a privately held, clinical-stage life science company dedicated to unlocking the full therapeutic potential of psychedelics, guided by science and enabled by drug discovery, clinical development and care delivery design. The company's comprehensive discovery, development and delivery capabilities enable it to target a broad spectrum of unmet needs within psychiatry, and beyond psychiatry. For more information, visit https://www.eleusisltd.com/.

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  2. FLORHAM PARK, N.J., May 25, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of the management team will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 10:00 a.m. ET.  

    Company management will also participate in one-on-one meetings during the virtual conference which runs from June 1-4, 2021.

    To access the live webcast and archived recording of the presentation, visit the News & Events section of the Phathom website at https://investors.phathompharma.com/news-events/events-and-presentations. The…

    FLORHAM PARK, N.J., May 25, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of the management team will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 10:00 a.m. ET.  

    Company management will also participate in one-on-one meetings during the virtual conference which runs from June 1-4, 2021.

    To access the live webcast and archived recording of the presentation, visit the News & Events section of the Phathom website at https://investors.phathompharma.com/news-events/events-and-presentations. The recording will be available for 90 days following the event.

    About Phathom Pharmaceuticals, Inc.

    Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information about Phathom, visit the Company's website at www.phathompharma.com or follow the Company on social media: LinkedIn at www.linkedin.com/company/phathompharma and Twitter @PhathomPharma.

    CONTACTS

    Media Contact:

    Nick Benedetto

    1-877-742-8466

    Investor Contact:

    Todd Branning

    1-877-742-8466



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    • Positive Phase 3 trial of vonoprazan in Helicobacter pylori (H. pylori) infection; New Drug Applications (NDAs) targeted for the fourth quarter of 2021
    • U.S. Food and Drug Administration (FDA) grants additional qualified infectious disease product (QIDP) designations to vonoprazan-based regimens with amoxicillin capsules; FDA had previously designated vonoprazan-based regimens with amoxicillin tablets as QIDP
    • Initiated Phase 2 trial evaluating vonoprazan on-demand in non-erosive reflux disease (NERD) – disease with large unmet need impacting an estimated more than 40 million people in the U.S.
    • Pivotal Phase 3 PHALCON-EE trial topline results expected in the fourth quarter of 2021

    FLORHAM PARK, N.J., May 11, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals…

    • Positive Phase 3 trial of vonoprazan in Helicobacter pylori (H. pylori) infection; New Drug Applications (NDAs) targeted for the fourth quarter of 2021
    • U.S. Food and Drug Administration (FDA) grants additional qualified infectious disease product (QIDP) designations to vonoprazan-based regimens with amoxicillin capsules; FDA had previously designated vonoprazan-based regimens with amoxicillin tablets as QIDP
    • Initiated Phase 2 trial evaluating vonoprazan on-demand in non-erosive reflux disease (NERD) – disease with large unmet need impacting an estimated more than 40 million people in the U.S.
    • Pivotal Phase 3 PHALCON-EE trial topline results expected in the fourth quarter of 2021

    FLORHAM PARK, N.J., May 11, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the first quarter of 2021 and provided an update on its recent clinical and organizational progress.

    "With both the impressive results from our pivotal Phase 3 PHALCON-HP trial and the initiation of our NERD development program, Phathom marks a strong start to 2021 having accomplished two of our key strategic imperatives for the year," said Terrie Curran, Phathom's President and Chief Executive Officer. "We are well-positioned to further build on this positive momentum as we anticipate several other significant catalysts in 2021 – including the expected readout from our pivotal Phase 3 trial in erosive esophagitis and the planned NDA submissions for vonoprazan-based regimens in the treatment of H. pylori infection."

    PHALCON-HP Clinical Development and Regulatory Updates:

    • On April 29, 2021, the company announced PHALCON-HP, a pivotal Phase 3 trial of vonoprazan in H. pylori infection, met all primary and secondary endpoints.
    • The PHALCON-HP study met the FDA required primary endpoints of noninferiority for vonoprazan in combination with amoxicillin and clarithromycin ("vonoprazan triple therapy") and vonoprazan in combination with amoxicillin ("vonoprazan dual therapy") compared to lansoprazole in combination with amoxicillin and clarithromycin ("lansoprazole triple therapy") in clarithromycin sensitive patient population.
    • The PHALCON-HP study also demonstrated vonoprazan triple therapy and vonoprazan dual therapy were superior in the eradication of H. pylori compared to lansoprazole triple therapy in all patients and patients with clarithromycin resistant strains of H. pylori.
    • Based on these positive results, Phathom remains on track to submit NDAs for both vonoprazan-based regimens in the fourth quarter of 2021.
    • In May 2021, the FDA granted additional QIDP designations to vonoprazan triple therapy and vonoprazan dual therapy, each containing amoxicillin capsules, for the treatment of H. pylori infection. The FDA had previously granted QIDP designations to vonoprazan-based H. pylori regimens containing amoxicillin tablets.

    Other Clinical and Business Updates:

    • In April 2021, the company commenced its NERD program by initiating PHALCON-NERD on-demand, a Phase 2 trial evaluating various doses of vonoprazan as an on-demand therapy for patients with NERD. The company expects to complete patient enrollment in the fourth quarter of 2021 and share topline results in the first half of 2022. NERD is a major subcategory of gastroesophageal reflux disease (GERD) and is characterized by reflux-related symptoms in the absence of esophageal erosions. There are estimated to be over 40 million people with NERD in the U.S.
    • The PHALCON-EE pivotal Phase 3 trial evaluating vonoprazan for both the healing and maintenance of healing of erosive esophagitis, as well as the relief of heartburn, remains on track with topline results expected in the fourth quarter of 2021.
    • Phathom will have a significant presence at the Digestive Disease Week® (DDW) Virtual Meeting scheduled for May 21-23, 2021. A vonoprazan-focused poster presentation, The Effect of Food on the Pharmacokinetics of the Potassium-competitive Acid Blocker Vonoprazan, has received recognition as a poster of distinction and will be presented in a virtual session. The poster will be presented live by Prof. Colin W. Howden, MD, FRCP, FACP, AGAF, FACG, on May 22, 2021 at 12:15 pm ET. More information about Phathom's DDW abstracts will be made available on www.phathompharma.com following the conference.

    First Quarter 2021 Financial Results:

    • First quarter 2021 net loss was $34.8 million compared to $20.1 million for the first quarter of 2020.
    • First quarter 2021 net loss included a non-cash charge related to stock-based compensation of $3.8 million compared to the first quarter of 2020 non-cash charges related to stock-based compensation of $0.6 million and change in fair value of warrant liabilities of ($0.1) million.
    • First quarter 2021 research and development expenses increased to $20.6 million compared to $15.9 million for the first quarter 2020 as a result of higher chemistry, manufacturing, and controls (CMC) costs, clinical trial costs, and personnel-related expenses. Compared to the fourth quarter of 2020, research and development expenses decreased by $21.0 million following the acceleration of patient enrollment in our Phase 3 trials during late 2020.
    • First quarter 2021 general and administrative expenses increased to $13.0 million compared to $4.5 million for the first quarter of 2020 due to the ongoing buildout of administrative and commercial functions.
    • As of March 31, 2021, cash and cash equivalents were $238.0 million. Cash and cash equivalents are expected to be sufficient to meet anticipated cash requirements into the fourth quarter of 2022.

    About Vonoprazan

    Vonoprazan is an investigational, oral small molecule potassium-competitive acid blocker (P-CAB). P-CABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has shown the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. The FDA has designated vonoprazan in combination with both amoxicillin and clarithromycin and with amoxicillin alone as qualified infectious disease products (QIDP) and awarded them Fast Track status for the treatment of H. pylori infection. Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 19 Phase 3 trials for vonoprazan and received marketing approval in Japan and numerous other countries in Asia and Latin America.

    About PHALCON-HP

    PHALCON-HP was a randomized, multicenter, Phase 3 trial that enrolled 1046 patients of which 992 patients with a confirmed H. pylori infection were randomized to one of three arms: vonoprazan 20 mg administered twice a day (BID) and amoxicillin 1g administered three times a day (TID) (n=324); vonoprazan 20 mg BID, amoxicillin 1g BID and clarithromycin 500 mg BID (n=338); and lansoprazole 30 mg BID, amoxicillin 1g BID and clarithromycin 500 mg BID (n=330). Each treatment regimen was administered for 14 days. Diagnoses of infection and test of cure were confirmed by 13C-urea breath test. Additional efficacy analyses were conducted using the pre-specified per protocol population (n=822), a subset of the mITT population comprised of patients who were protocol compliant.

    About PHALCON-EE

    PHALCON-EE is a randomized, double-blind, two-phase, multicenter Phase 3 trial that has completed enrollment of patients with erosive esophagitis (EE) in the U.S. and Europe. The first phase of the trial is evaluating the efficacy and safety of vonoprazan 20 mg administered once-daily (QD) compared to lansoprazole 30 mg QD for the healing of EE for up to eight weeks. The second phase of the trial is evaluating the efficacy and safety of vonoprazan 10 mg QD and 20 mg QD compared to lansoprazole 15 mg QD for the maintenance of healing of EE for 24 weeks. Both phases are also evaluating heartburn symptoms.

    About PHALCON-NERD on-demand

    PHALCON-NERD on-demand is a randomized, double-blind, multicenter Phase 2 study evaluating the efficacy and safety of various doses of vonoprazan compared to placebo for relief of episodic heartburn in subjects with symptomatic non-erosive gastroesophageal reflux disease or NERD. The first phase of the trial is a four-week, open-label run-in period with daily dosing of vonoprazan 20 mg. Following the run-in period, responders will be evenly randomized to one of three doses of vonoprazan (10 mg, 20 mg, and 40 mg) or placebo and treated on-demand for six weeks. The primary endpoint is evaluating the proportion of heartburn episodes with complete and durable relief. Secondary endpoints will also assess different aspects of the speed of onset of symptom relief and durability of relief, as well as number of doses of study drug and use of rescue antacids.

    About Phathom Pharmaceuticals, Inc.

    Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information about Phathom, visit the Company's website at www.phathompharma.com or follow the Company on social media: LinkedIn at www.linkedin.com/company/phathompharma and Twitter @PhathomPharma.

    Forward Looking Statements

    Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the expected availability of topline results from the PHALCON-EE Phase 3 clinical trial; the expected submission of New Drug Applications for the eradication of H. pylori infection; the expected completion of enrollment in the Phase 2 NERD study; and Phathom's belief that vonoprazan could represent an important treatment option for acid-related diseases, if approved. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom's business, including, without limitation: potential additional delays in the commencement, enrollment and completion of clinical trials due to the COVID-19 pandemic and other factors outside of Phathom's control; patients already enrolled in PHALCON-EE and the Phase 2 NERD study may not complete the clinical trials or public health conditions and governmental restrictions may lead Phathom to stop such trial all together, which may adversely impact its trial results and development plans; Phathom's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; QIDP and Fast Track designations may be withdrawn or not actually lead to a faster development or regulatory review or extended exclusivity, and would not assure FDA approval of vonoprazan; Phathom's ability to obtain and maintain intellectual property protection for vonoprazan; Phathom's ability to comply with its license agreement with Takeda; Phathom's ability to maintain undisrupted business operations due to the ongoing spread of the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain, and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    CONTACTS

    Media Contact:

    Nick Benedetto

    1-877-742-8466

    Investor Contact:

    Todd Branning

    1-877-742-8466



    PHATHOM PHARMACEUTICALS, INC.

    Balance Sheets

    (Unaudited)

    (in thousands, except share and par value amounts)

     March 31,

    2021
     December 31,

    2020
    Assets       
    Current assets:       
    Cash and cash equivalents$237,974  $287,496 
    Prepaid expenses and other current assets (including related party amounts of $0 and $82, respectively) 4,836   3,872 
    Total current assets 242,810   291,368 
    Property, plant and equipment, net 907   986 
    Operating lease right-of-use assets 2,261   2,373 
    Other long-term assets 385   384 
    Total assets$246,363  $295,111 
            
    Liabilities and Stockholders' Equity       
    Current liabilities:       
    Accounts payable (including related party amounts of $335 and $173, respectively)$10,857   16,782 
    Accrued clinical trial expenses 10,868   19,997 
    Accrued expenses (including related party amounts of $1,000 and $734, respectively) 6,566   10,606 
    Accrued interest 312   312 
    Current portion of long-term debt 11,765   7,353 
    Operating lease liabilities, current 477   474 
    Total current liabilities 40,845   55,524 
            
    Long-term debt, net of discount 35,587   39,634 
    Operating lease liabilities 1,467   1,557 
    Other long-term liabilities 4,125   4,125 
    Total liabilities 82,024   100,840 
            
    Commitments and contingencies       
            
    Stockholders' equity:       
    Preferred stock, $0.0001 par value; authorized shares — 40,000,000 at March 31, 2021 and December 31, 2020; no shares issued and outstanding at

    March 31, 2021 and December 31, 2020
         
    Common stock, $0.0001 par value; authorized shares — 400,000,000; issued shares — 31,321,613 and 31,262,769 at March 31, 2021 and December 31, 2020, respectively; outstanding shares — 28,876,510 and 28,516,010 at March 31, 2021 and December 31, 2020, respectively 3   3 
    Additional paid-in capital 584,666   579,755 
    Accumulated deficit (420,330)  (385,487)
    Total stockholders' equity 164,339   194,271 
    Total liabilities and stockholders' equity$246,363  $295,111 



    PHATHOM PHARMACEUTICALS, INC.

    Statements of Operations and Comprehensive Loss

    (Unaudited)

    (in thousands, except share and per share amounts)

     Three Months Ended

    March 31,
     2021 2020
    Operating expenses:       
    Research and development (includes related party amounts of $939 and $404 respectively)$20,580  $15,865 
    General and administrative (includes related party amounts of $16 and $43, respectively) 13,004   4,510 
    Total operating expenses 33,584   20,375 
            
    Loss from operations (33,584)  (20,375)
            
    Other income (expense):       
    Interest income 14   878 
    Interest expense (1,272)  (738)
    Change in fair value of warrant liabilities    95 
    Other income (expense) (1)  (1)
    Total other income (expense) (1,259)  234 
    Net loss and comprehensive loss$(34,843) $(20,141)
    Net loss per share, basic and diluted$(0.96) $(0.62)
    Weighted-average shares of common stock outstanding, basic and diluted 36,298,968   32,470,402 

     



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  3. FLORHAM PARK, N.J., May 06, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of the management team will participate in a fireside chat at the Bank of America Securities 2021 Virtual Healthcare Conference on Thursday, May 13, 2021 at 8:45 a.m. ET.  

    Company management will also participate in one-on-one meetings during the virtual conference.

    To access the live webcast and archived recording of the presentation, visit the News & Events section of the Phathom website at https://investors.phathompharma.com/news-events/events-and-presentations. The recording…

    FLORHAM PARK, N.J., May 06, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of the management team will participate in a fireside chat at the Bank of America Securities 2021 Virtual Healthcare Conference on Thursday, May 13, 2021 at 8:45 a.m. ET.  

    Company management will also participate in one-on-one meetings during the virtual conference.

    To access the live webcast and archived recording of the presentation, visit the News & Events section of the Phathom website at https://investors.phathompharma.com/news-events/events-and-presentations. The recording will be available for 90 days following the event.

    About Phathom Pharmaceuticals, Inc.

    Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information about Phathom, visit the Company's website at www.phathompharma.com or follow the Company on follow the Company on social media: LinkedIn at www.linkedin.com/company/phathompharma and Twitter @PhathomPharma.

    CONTACTS

    Media Contact:

    Nick Benedetto

    1-877-742-8466

    Investor Contact:

    Todd Branning

    1-877-742-8466



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    • Both vonoprazan-based treatment regimens demonstrated superior eradication rates vs. a standard of care proton pump inhibitor (PPI)-based triple therapy

    • New Drug Application (NDA) submissions targeted for Q4 2021

    • Phathom to host conference call and live webcast today, April 29, 2021 at 4:30 pm ET

    FLORHAM PARK, N.J., April 29, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that in PHALCON-HP, its pivotal Phase 3 clinical trial for the eradication of H. pylori infection, both vonoprazan-based regimens successfully met their primary endpoints and met all secondary endpoints…

    • Both vonoprazan-based treatment regimens demonstrated superior eradication rates vs. a standard of care proton pump inhibitor (PPI)-based triple therapy



    • New Drug Application (NDA) submissions targeted for Q4 2021



    • Phathom to host conference call and live webcast today, April 29, 2021 at 4:30 pm ET

    FLORHAM PARK, N.J., April 29, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that in PHALCON-HP, its pivotal Phase 3 clinical trial for the eradication of H. pylori infection, both vonoprazan-based regimens successfully met their primary endpoints and met all secondary endpoints. The trial studied vonoprazan in combination with amoxicillin and clarithromycin ("vonoprazan triple therapy") and vonoprazan in combination with amoxicillin ("vonoprazan dual therapy") compared to lansoprazole in combination with amoxicillin and clarithromycin ("lansoprazole triple therapy"). PHALCON-HP is the largest Phase 3 registration trial ever conducted in H. pylori infection, randomizing 992 patients with confirmed H. pylori infection.

    Phase 3 Topline Results

    Primary endpoint analysis

    The primary endpoints in the PHALCON-HP study were non-inferiority of the H. pylori eradication rate for each of vonoprazan triple and dual therapy compared to lansoprazole triple therapy. Based on U.S. Food and Drug Administration (FDA) feedback, the primary endpoint excluded patients with amoxicillin or clarithromycin resistant strains of H. pylori.

    Both vonoprazan-based regimens successfully met their primary endpoints. In the modified intent-to-treat (mITT) population, H. pylori eradication rates were 84.7% with vonoprazan triple therapy and 78.5% for vonoprazan dual therapy compared to 78.8% with lansoprazole triple therapy (p<0.0001 and p=0.0037, respectively, for non-inferiority).

    Additional efficacy analyses were conducted using the pre-specified per protocol population, a subset of the mITT population comprised of patients who were protocol compliant as defined by FDA draft Guidance for Industry1. In the per protocol population, H. pylori eradication rates were 90.4% with vonoprazan triple therapy and 81.2% with vonoprazan dual therapy compared to 82.1% with lansoprazole triple therapy (p<0.0001 and p=0.0077, respectively, for non-inferiority).

    Secondary endpoint analysis

    Vonoprazan triple therapy and vonoprazan dual therapy also met all secondary endpoints, demonstrating superior eradication rates versus lansoprazole triple therapy in all patients and patients with clarithromycin resistant strains of H. pylori. Patients with clarithromycin resistant strains comprised 20.3% of the PHALCON-HP study population.

    Vonoprazan triple therapy

    The H. pylori eradication rate of vonoprazan triple therapy was superior to that of lansoprazole triple therapy among all patients in both the mITT population (80.8% vs. 68.5%; p=0.0001) and the per protocol population (85.7% vs. 70.0%; p<0.0001).

    The H. pylori eradication rate with vonoprazan triple therapy was superior to that of lansoprazole triple therapy in the subset of patients with H. pylori strains resistant to clarithromycin in both the mITT population (65.8% vs. 31.9%; p<0.0001) and the per protocol population (67.2% vs. 29.0%; p<0.0001).

    Vonoprazan dual therapy

    The H. pylori eradication rate of vonoprazan dual therapy was superior to that of lansoprazole triple therapy among all patients in both the mITT population (77.2% vs. 68.5%; p=0.0063) and the per protocol population (81.1% vs. 70.0%; p=0.0013).

    The H. pylori eradication rate of vonoprazan dual therapy was superior to that of lansoprazole triple therapy in the subset of patients with H. pylori strains resistant to clarithromycin in both the mITT population (69.6% vs. 31.9%; p<0.0001) and the per protocol population (79.5% vs. 29.0%; p<0.0001).

    "Acid suppression is a key factor in addressing shortcomings associated with currently available H. pylori treatments, especially in light of increased resistance to antibiotics, including clarithromycin," said Professor William D. Chey, M.D., AGAF, FACG, FACP, Professor of Medicine and Director of the GI Physiology Laboratory at the University of Michigan. "I am very impressed with the results of PHALCON-HP which demonstrate that replacing a PPI with vonoprazan in H. pylori treatment regimens has the potential to meaningfully enhance eradication rates that have been declining over the last two decades. Further, the potential to limit the use of clarithromycin with a dual therapy regimen has the potential to transform clinical practice."

    Safety profile

    Both vonoprazan-based regimens were generally well tolerated with a safety profile comparable to lansoprazole triple therapy. The most common adverse events (>2.0%) reported in the vonoprazan triple therapy, vonoprazan dual therapy, and lansoprazole triple therapy arms, respectively, were diarrhea (4.0%, 5.2%, and 9.6%), dysgeusia (4.3%, 0.6%, and 6.1%), nausea (1.7%, 1.7% and 2.6%), headache (2.6%, 1.4%, 1.4%) and vaginal infections (2.3%, 0.9%, 0.3%). Overall rates of discontinuation due to adverse events were 2.3% for vonoprazan triple therapy-treated patients, 0.9% for vonoprazan dual therapy-treated patients, and 1.4% for lansoprazole triple therapy-treated patients.

    Full results from the PHALCON-HP study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.

    "We believe the topline results of our PHALCON-HP study support the potential of vonoprazan-based therapies to change H. pylori treatment," said Terrie Curran, Phathom's President and Chief Executive Officer. "There are estimated to be over 200 million people infected with H. pylori in the United States and Europe, and our market research among patients and physicians show antibiotic resistance, coupled with complexity of treatment, as leading causes of eradication failure. Based on these results, which further build on the robust data previously reported from clinical studies of vonoprazan-based regimens in Japan, we plan to submit NDAs with the FDA for vonoprazan dual and triple therapy in H. pylori before the end of the year. Phathom thanks all the patients, physicians, and clinical sites for their role in the PHALCON-HP trial and for helping in our efforts to advance the treatment landscape for the millions of patients suffering with H. pylori infection."

    Conference call on the PHALCON-HP trial results

    Phathom will host a webcasted conference call today, Thursday, April 29, 2021 at 4:30 pm ET to discuss the PHALCON-HP study results.

    To view the live webcast, visit https://investors.phathompharma.com/news-events/events-and-presentations. Please join approximately 10 minutes prior to the scheduled start time.

    A replay of the webcast and the slide presentation will be available after the meeting on the News & Events section of the Phathom website at https://investors.phathompharma.com/news-events/events-and-presentations.

    About Helicobacter pylori (H. pylori) infection

    H. pylori is a bacterial pathogen that is estimated to infect over 200 million individuals in the United States and Europe. Approximately 50% of the world and 36% of the US population are infected with the bacterium.2 In many cases, H. pylori is acquired in childhood and through intrafamilial transmission.3 As a result of the chronic inflammation induced by H. pylori infection, infected patients develop a range of pathologies including dyspepsia, peptic ulcer disease, gastric cancer, and mucosa-associated lymphoid tissue (MALT) lymphoma.4 Studies have found that roughly 1 in 5 patients treated for H. pylori will fail first line therapy when using standard clarithromycin triple therapy.2,5  

    About PHALCON-HP

    PHALCON-HP was a randomized, multicenter, Phase 3 trial that enrolled 1046 patients of which 992 patients with a confirmed H. pylori infection were randomized to one of three arms: vonoprazan 20 mg administered twice a day (BID) and amoxicillin 1g administered three times a day (TID) (n=324); vonoprazan 20 mg BID, amoxicillin 1g BID and clarithromycin 500 mg BID (n=338); and lansoprazole 30 mg BID, amoxicillin 1g BID and clarithromycin 500 mg BID (n=330). Each treatment regimen was administered for 14 days. Diagnoses of infection and test of cure were confirmed by 13C-urea breath test. Additional efficacy analyses were conducted using the pre-specified per protocol population (n=822), a subset of the mITT population comprised of patients who were protocol compliant.  

    About Vonoprazan

    Vonoprazan is an investigational, oral small molecule potassium-competitive acid blocker (P-CAB). P-CABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has shown the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. The FDA has awarded Fast Track designation to vonoprazan in combination with both amoxicillin and clarithromycin and with amoxicillin alone for the treatment of H. pylori infection. Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 19 Phase 3 trials for vonoprazan and received marketing approval in Japan and numerous other countries in Asia and Latin America.

    About Phathom

    Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information about Phathom, visit the Company's website at www.phathompharma.com or follow the Company on social media: LinkedIn at www.linkedin.com/company/phathompharma and Twitter @PhathomPharma.

    Forward Looking Statements

    Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the expected submission of New Drug Applications for the eradication of H. pylori infection; and the potential for vonoprazan-based therapies to meaningfully enhance H. pylori eradication rates, limit the use of clarithromycin, and address shortcomings associated with currently available treatments. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom's business, including, without limitation: reported top-line data is based on preliminary analysis of key efficacy and safety data is subject to more audit and verification procedures that could result in material changes in the final data; we may experience delays submitting the NDAs including in the event that the FDA does not agree with the Company's interpretation of the data or feedback from the FDA that may be inconsistent with feedback received at prior meetings with the FDA; Phathom's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom's pending qualified infectious disease product (QIDP) requests may not be granted and previously granted QIDP and Fast Track designations may be withdrawn or not actually lead to a faster development or regulatory review or extended exclusivity, and would not assure FDA approval of vonoprazan; Phathom's ability to obtain and maintain intellectual property protection for vonoprazan; Phathom's ability to comply with its license agreement with Takeda; Phathom's ability to maintain undisrupted business operations due to the ongoing spread of the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain, and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    Contacts

    Media Contact:

    Nick Benedetto

    1-877-742-8466

    Investor Contact:

    Todd Branning

    1-877-742-8466

    ____________________

    1 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/helicobacter-pylori-associated-duodenal-ulcer-disease-adults-developing-drugs-treatment

    2 Hooi et al. Gastroenterology. 2017;153:420.

    3 Chey et al. Am J Gastroenterol.2017;112:212.

    4 Malfertheiner et al. Gut. 2017;66:6.

    5 Alsamman et al. Dig Dis Sci. 2019;64:2893.



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