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Phathom Pharmaceuticals, Inc. (PHAT)

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Previous Close34.09
Open35.65
Bid34.94 x 800
Ask49.50 x 1100
Day's Range33.87 - 36.51
52 Week Range28.10 - 64.54
Volume148,070
Avg. Volume101,911
Market Cap1B
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)-23.02
Earnings DateAug 04, 2021 - Aug 09, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est56.83
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  • Phathom Pharmaceuticals Reports First Quarter 2021 Results and Provides Recent Business Updates
    GlobeNewswire

    Phathom Pharmaceuticals Reports First Quarter 2021 Results and Provides Recent Business Updates

    Positive Phase 3 trial of vonoprazan in Helicobacter pylori (H. pylori) infection; New Drug Applications (NDAs) targeted for the fourth quarter of 2021U.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 QIDPInitiated 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 VonoprazanVonoprazan 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-HPPHALCON-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-EEPHALCON-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-demandPHALCON-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 Benedetto1-877-742-8466media@phathompharma.com Investor Contact:Todd Branning 1-877-742-8466ir@phathompharma.com PHATHOM PHARMACEUTICALS, INC.Balance Sheets (Unaudited)(in thousands, except share and par value amounts) March 31,2021 December 31,2020Assets 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 atMarch 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 EndedMarch 31, 2021 2020Operating 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

  • Phathom Pharmaceuticals to Present at the Bank of America Securities 2021 Virtual Healthcare Conference
    GlobeNewswire

    Phathom Pharmaceuticals to Present at the Bank of America Securities 2021 Virtual Healthcare Conference

    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. CONTACTSMedia Contact:Nick Benedetto1-877-742-8466media@phathompharma.com Investor Contact:Todd Branning1-877-742-8466ir@phathompharma.com

  • Phathom Pharmaceuticals Announces Positive Topline Results from Pivotal Phase 3 Trial of Vonoprazan in Helicobacter pylori (H. pylori) Infection; Study Met All Primary and Secondary Endpoints
    GlobeNewswire

    Phathom Pharmaceuticals Announces Positive Topline Results from Pivotal Phase 3 Trial of Vonoprazan in Helicobacter pylori (H. pylori) Infection; Study Met All Primary and Secondary Endpoints

    Both vonoprazan-based treatment regimens demonstrated superior eradication rates vs. a standard of care proton pump inhibitor (PPI)-based triple therapyNew Drug Application (NDA) submissions targeted for Q4 2021Phathom 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 therapyThe 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 therapyThe 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 profileBoth 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 resultsPhathom 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-HPPHALCON-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 VonoprazanVonoprazan 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 PhathomPhathom 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 StatementsPhathom 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 Benedetto1-877-742-8466media@phathompharma.com Investor Contact:Todd Branning 1-877-742-8466ir@phathompharma.com ____________________1 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/helicobacter-pylori-associated-duodenal-ulcer-disease-adults-developing-drugs-treatment2 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.