PHAT Phathom Pharmaceuticals Inc.

34.96
+1.31  (+4%)
Previous Close 33.65
Open 34.28
52 Week Low 28.1
52 Week High 64.54
Market Cap $996,919,710
Shares 28,516,010
Float 17,722,655
Enterprise Value $759,297,189
Volume 55,656
Av. Daily Volume 100,007
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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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Drug Pipeline

Drug Stage Notes
Vonoprazan
Non-erosive reflux disease (NERD)
Phase 2
Phase 2
Phase 2 trial to be initiated 2Q 2021.

Latest News

  1. 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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  2. FLORHAM PARK, N.J., April 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 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13, 2021 at 10:15 a.m. ET.

    Company management will also participate in one-on-one meetings during the virtual conference which runs from April 12-15, 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

    FLORHAM PARK, N.J., April 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 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13, 2021 at 10:15 a.m. ET.

    Company management will also participate in one-on-one meetings during the virtual conference which runs from April 12-15, 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

    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



    Primary Logo

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  3. FLORHAM PARK, N.J., March 30, 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 fourth quarter and full year ended December 31, 2020 and provided highlights of pipeline and business progress.

    "During 2020 our teams made significant progress advancing the clinical development of vonoprazan and building the foundation to become a leader in the gastrointestinal space," said Terrie Curran, President and Chief Executive Officer of Phathom. "Our accomplishments position Phathom for a catalyst-rich year in 2021, when we expect to share results from our…

    FLORHAM PARK, N.J., March 30, 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 fourth quarter and full year ended December 31, 2020 and provided highlights of pipeline and business progress.

    "During 2020 our teams made significant progress advancing the clinical development of vonoprazan and building the foundation to become a leader in the gastrointestinal space," said Terrie Curran, President and Chief Executive Officer of Phathom. "Our accomplishments position Phathom for a catalyst-rich year in 2021, when we expect to share results from our pivotal Phase 3 trials in H. pylori infection and erosive esophagitis and expand our vonoprazan development program into non-erosive reflux disease (NERD). Building on our momentum from 2020, we are well-positioned financially and operationally to continue our efforts in bringing vonoprazan to the millions of underserved patients with acid-related disorders."

    Fourth Quarter 2020 and Recent Business Highlights:

    • Completed patient enrollment in pivotal Phase 3 trial for vonoprazan in erosive esophagitis (PHALCON-EE).
    • Completed patient enrollment in pivotal Phase 3 trial for vonoprazan in H. pylori infection (PHALCON-HP).
    • Announced the planned expansion of vonoprazan development program into NERD.
    • Completed a successful public offering of common stock with net proceeds of approximately $89 million to fund the clinical development of vonoprazan and for working capital and general corporate purposes, including pre-commercial activities.

    2021 Expected Milestones:

    • Topline results for PHALCON-HP in the second quarter of 2021.
    • Initiation of Phase 2 non-erosive reflux disease (NERD) trial in the second quarter of 2021.
    • NDA submission for H. pylori in the second half of 2021.
    • Topline results for PHALCON-EE in the second half of 2021.
    • Enrollment completion of Phase 2 NERD trial in the second half of 2021.

    Fourth Quarter and Full Year 2020 Financial Results:

    • Fourth quarter net loss for 2020 was $53.7 million, compared to $98.0 million for fourth quarter 2019.
    • Fourth quarter net loss for 2020 was driven by a net loss from operations of $52.4 million, which included a non-cash charge related to stock-based compensation of $2.3 million.
    • Fourth quarter net loss for 2019 was driven by a non-cash charge related to the change in fair value of warrant liabilities of $37.2 million, a non-cash charge related to the change in fair value of convertible promissory notes of $44.6 million, and net loss from operations of $15.7 million, which included a non-cash charge related to stock-based compensation of $0.3 million.
    • Fourth quarter 2020 research and development expenses increased to $41.6 million compared to $12.7 million for fourth quarter 2019 as a result of higher clinical trial costs and personnel-related expenses related to the development of vonoprazan, including the acceleration of patient enrollment in the current quarter.
    • Fourth quarter 2020 general and administrative expenses increased to $10.8 million compared to $3.0 million for fourth quarter 2019 due to the ongoing buildout of administrative and commercial functions.
    • Full year net loss for 2020 was $129.1 million, compared to $255.1 million in 2019.
    • Full year net loss for 2020 was driven by a net loss from operations of $125.7 million, which included a non-cash charge related to stock-based compensation of $5.8 million.
    • Full year net loss for 2019 was driven by a non-cash charge related to the change in fair value of warrant liabilities of $96.3 million, a non-cash charge related to the change in fair value of convertible promissory notes of $49.5 million, and net loss from operations of $106.2 million, which included a non-cash charge related to stock-based compensation of $0.4 million.
    • Full year research and development expenses for 2020 increased to $98.2 million compared to $20.4 million in 2019 as a result of higher clinical trial costs and personnel-related expenses following the in-licensing of vonoprazan in the second quarter of 2019, including the acceleration of patient enrollment in 2020.
    • In-process research and development expenses of $78.9 million in 2019 consisted of the purchase price for the vonoprazan research and development assets we in-licensed in the second quarter of 2019.
    • Full year general and administrative expenses for 2020 increased to $27.5 million from $6.9 million in 2019 due to the ongoing buildout of administrative and commercial functions.



    • As of December 31, 2020, cash and cash equivalents were $287.5 million.

    About Vonoprazan

    Vonoprazan is an 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. 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-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-HP

    PHALCON-HP is a randomized, multicenter, Phase 3 trial that has completed enrollment of patients with H. pylori infection in the U.S. and Europe. Participants are randomized 1:1:1 to one of three arms: vonoprazan 20 mg administered twice a day (BID) and amoxicillin 1g administered three times a day (TID); vonoprazan 20 mg BID, amoxicillin 1 g BID and clarithromycin 500 mg BID; and lansoprazole 30 mg BID, amoxicillin 1 g BID and clarithromycin 500 mg BID. Each treatment regimen is being administered for 14 days. PHALCON-HP is evaluating the percentage of patients with successful eradication of H. pylori infection.

    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 availability of topline results from the PHALCON-EE and PHALCON-HP Phase 3 clinical trials; the expected submission of a New Drug Application for the eradication of H. pylori infection; and the expected initiation and completion of enrollment in the Phase 2 NERD study. 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 PHALCON-HP may not complete the clinical trials or public health conditions and governmental restrictions may lead Phathom to stop such trials 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.

    Statements of Operations and Comprehensive Loss

    (Unaudited)

    (in thousands, except share and per share amounts)

      Three Months Ended

    December 31,
      Year Ended

    December 31,
     
      2020  2019  2020  2019 
    Operating expenses:                
    Research and development (includes related party amounts of $1,136, $1,036, $2,812, and $1,243 respectively) $41,654  $12,704  $98,148  $20,374 
    In-process research and development           78,897 
    General and administrative (includes related party amounts of $18, $138, $157, and $312, respectively)  10,785   2,989   27,517   6,944 
    Total operating expenses  52,439   15,693   125,665   106,215 
                     
    Loss from operations  (52,439)  (15,693)  (125,665)  (106,215)
                     
    Other income (expense):                
    Interest income  16   559   1,091   1,089 
    Interest expense (includes related party amounts of $0, $(93), $0 and $(590), respectively)  (1,296)  (1,039)  (4,581)  (4,177)
    Change in fair value of warrant liabilities (includes related party amounts of $0, $(37,247), $0 and $(96,278), respectively)     (37,212)  95   (96,272)
    Change in fair value of convertible promissory notes (includes related party amounts of $0, $(9,888), $0, and $(10,941), respectively)     (44,618)     (49,546)
    Other income (expense)  (2)  (3)  (8)  (10)
    Total other income (expense)  (1,282)  (82,313)  (3,403)  (148,916)
    Net loss $(53,721) $(98,006) $(129,068) $(255,131)
    Net loss per share, basic and diluted $(1.58) $(3.97) $(3.88) $(22.45)
    Weighted-average shares of common stock outstanding, basic and diluted  34,060,291   24,706,661   33,228,158   11,366,916 

    PHATHOM PHARMACEUTICALS, INC.

    Balance Sheets

    (Unaudited)

    (in thousands, except share and par value amounts)

      December 31,

    2020
      December 31,

    2019
     
    Assets        
    Current assets:        
    Cash and cash equivalents $287,496  $243,765 
    Prepaid expenses and other current assets (including related party amounts of $82 and $0, respectively)  3,872   11,836 
    Total current assets  291,368   255,601 
    Property, plant and equipment, net  986   463 
    Operating lease right-of-use assets  2,373   933 
    Other long-term assets  384   181 
    Total assets $295,111  $257,178 
             
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable (including related party amounts of $173 and $200, respectively) $16,782  $699 
    Accrued clinical trial expenses  19,997    
    Accrued expenses (including related party amounts of $734 and $308, respectively)  10,606   2,319 
    Accrued interest  312   156 
    Current portion of long-term debt  7,353    
    Operating lease liabilities, current  474   161 
    Warrant liabilities     413 
    Total current liabilities  55,524   3,748 
             
    Long-term debt, net of discount  39,634   22,777 
    Operating lease liabilities  1,557   635 
    Other long-term liabilities  4,125   2,063 
    Total liabilities  100,840   29,223 
             
    Commitments and contingencies        
             
    Stockholders' equity:        
    Preferred stock, $0.0001 par value; authorized shares — 40,000,000 at December 31, 2020 and 2019; no shares issued and outstanding at December 31, 2020 and 2019      
    Common stock, $0.0001 par value; authorized shares — 400,000,000 at December 31, 2020 and 2019; issued shares — 31,262,769 and 28,964,506 at December 31, 2020 and 2019, respectively; outstanding shares — 28,516,010 and 24,728,258 at December 31, 2020 and 2019, respectively  3   2 
    Additional paid-in capital  579,755   484,372 
    Accumulated deficit  (385,487)  (256,419)
    Total stockholders' equity  194,271   227,955 
    Total liabilities and stockholders' equity $295,111  $257,178 

     



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    • Topline results expected in second quarter of 2021
    • NDA submission for H. pylori expected in second half of 2021

    FLORHAM PARK, N.J., Jan. 19, 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 announced that it has completed patient enrollment in PHALCON-HP, a pivotal Phase 3 clinical trial of vonoprazan in combination with amoxicillin (vonoprazan dual therapy) and vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) for the eradication of H. pylori infection. Phathom continues to expect topline results from the study in the second quarter of 2021…

    • Topline results expected in second quarter of 2021

    • NDA submission for H. pylori expected in second half of 2021

    FLORHAM PARK, N.J., Jan. 19, 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 announced that it has completed patient enrollment in PHALCON-HP, a pivotal Phase 3 clinical trial of vonoprazan in combination with amoxicillin (vonoprazan dual therapy) and vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) for the eradication of H. pylori infection. Phathom continues to expect topline results from the study in the second quarter of 2021.

    PHALCON-HP is a randomized, multicenter, Phase 3 trial that has enrolled over 1,000 patients with H. pylori infection. Participants are evenly randomized to one of three arms: vonoprazan 20 mg administered twice a day (BID) and amoxicillin 1g administered three times a day (TID); vonoprazan 20 mg BID, amoxicillin 1g BID and clarithromycin 500 mg BID; and lansoprazole 30 mg BID, amoxicillin 1g BID and clarithromycin 500 mg BID. Each treatment regimen is administered for 14 days. The primary endpoint is the percentage of patients with successful eradication of H. pylori infection.

    "The completion of patient enrollment in the PHALCON-HP trial marks another significant milestone for Phathom and for the millions of people with H. pylori infection. In the U.S. and Europe, one-in-three adults are believed to carry H. pylori, which, if left untreated, can lead to dyspeptic symptoms, ulcers, and gastric cancer. These regions are experiencing declining H. pylori eradication rates due to increasing antibiotic resistance which we believe can be addressed with more potent inhibition of gastric acid. Our ability to enroll patients in the PHALCON-HP trial during a pandemic highlights the demand for new therapeutic regimens to combat this chronic bacterial infection," said Azmi Nabulsi, M.D., Phathom's Chief Operating Officer. "Phathom greatly appreciates the commitment and execution of our investigators and clinicians involved in PHALCON-HP and thanks all our patient volunteers for their participation."

    PHALCON-HP is one of two Phase 3 trials evaluating vonoprazan in gastrointestinal diseases. The second trial, PHALCON-EE, is a randomized, double-blind, two-phase, multicenter trial evaluating vonoprazan in the treatment of erosive esophagitis (EE). Patient enrollment in PHALCON-EE was completed in November 2020 with topline results expected in the second half of 2021.

    About Vonoprazan

    Vonoprazan is an 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 U.S. Food and Drug Administration (FDA) has designated as a qualified infectious disease product (QIDP) and awarded Fast Track status to vonoprazan for the treatment of H. pylori infection in combination with both amoxicillin and clarithromycin and with amoxicillin alone. 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 availability of topline results from the PHALCON-EE and PHALCON-HP Phase 3 clinical trials; the expected submission of a New Drug Application for the eradication of H. pylori infection, and the potential to receive regulatory and exclusivity benefits as a result of QIDP and Fast Track designations. 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 PHALCON-HP may not complete the clinical trials or public health conditions and governmental restrictions may lead Phathom to stop such trials 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 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



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