Severe Acute Respiratory Syndrome

BOTHELL, Wash., March 31, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the 12 months ended December 31, 2024, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “Our novel, potent antiviral compounds for norovirus, influenza and coronavirus address critical gaps in global health where effective treatments or vaccines are currently lacking,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “We plan to initiate a norovirus human challenge study in the U.S. later this year to evaluate our pan-viral protease inhibitor CDI-988 for the potential treatment and prevention of norovirus infection. The big surge in reported norovirus outbreaks is possibly due to norovirus variants switching from GII.4 to GII.17, as well as increased social gathering after the COVID-19 pandemic. Norovirus is the most common cause of acute gastroenteritis and there are no approved therapeutics or vaccines, making it a compelling target. “We are optimistic that our oral PB2 inhibitor CC-42344 will have potential as a treatment for seasonal influenza A infection and pandemic avian influenza,” he added. “Following the unexpected low infection rate from the Phase 2a challenge study that precluded us from obtaining meaningful human efficacy data, we plan to continue the influenza challenge study.” “News coverage in recent months of norovirus and avian flu outbreaks underscore the urgent need for new antiviral solutions,” said James Martin, CFO and co-CEO of Cocrystal. “We are advancing our first- and best-in-class antiviral drug compounds that were designed using our Nobel Prize-winning structure-based technologies for these high-value viral targets that address multibillion-dollar markets.” Antiviral Product Pipeline Overview We apply our proprietary structure-based drug discovery platform technology for developing broad-spectrum antivirals that inhibit viral replication. By designing and selecting candidates that target highly conserved regions of the viral enzymes, we seek to develop drugs that are effective against the virus and mutations of the virus, while reducing off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes. Influenza Programs Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for an estimated $11.2 billion in direct and indirect costs in the U.S. annually. Oral CC-42344 for the treatment of pandemic and seasonal influenza A Our novel PB2 inhibitor CC-42344 showed excellent in vitro antiviral activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study.In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).In May 2024 we completed enrollment in the Phase 2a human challenge study.In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows.In December 2024 we announced a plan to extend the CC-42344 human challenge study due to unexpectedly low influenza infection among study participants. Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A Our preclinical testing showed superior pulmonary pharmacology with CC-42344 including high exposure to drug and a long half-life.We have completed CC-42344 inhalation formulation development and GLP toxicology studies. Influenza A/B program Our efforts to develop a preclinical lead of novel influenza replication inhibitors are ongoing. Norovirus Program Norovirus symptoms can include severe nausea, vomiting and diarrhea. An estimated 685 million cases and an estimated 50,000 child deaths worldwide are attributed to norovirus each year, with an estimated societal cost of $60 billion. By targeting viral replication, we believe it is possible to develop an effective treatment and/or prophylaxis for closed environments for all genogroups of norovirus. Oral pan-viral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for noroviruses and coronaviruses.CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains.In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CDI-988 in healthy volunteers.In August 2023 we announced our selection of CDI-988 as our lead compound for the oral treatment for noroviruses, in addition to coronaviruses.In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a higher-dose cohort.We expect to report topline results from the high-dose healthy volunteer cohort with CDI-988 in the second quarter of 2025.We plan to initiate a human challenge study in the U.S. in 2025 to evaluate CDI-988 as a norovirus treatment and prophylaxis. SARS-CoV-2 and Other Coronavirus Programs By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031. Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties.In September 2023 we dosed the first healthy subject in our dual pan-norovirus/pan-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications.In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohort in the Phase 1 study.In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a higher-dose cohort.We expect to report topline results from the higher dose cohort in the CDI-988 Phase 1 study in the second quarter of 2025. 2024 Financial Results Research and development (R&D) expenses for 2024 were $12.5 million, compared with $15.2 million for 2023. The decrease was primarily due to the timing of clinical study costs. General and administrative (G&A) expenses for 2024 were $5.3 million, compared with $6.0 million for 2023, with the $0.7 million decrease primarily due to a reduction of insurance costs and other expenses. During 2023 the Company received $2.6 million related to litigation with an insurer. The net loss for 2024 was $17.5 million, or $1.72 per share, compared with the net loss for 2023 of $18.0 million, or $1.87 per share. For 2024 the year over-year-net loss was reduced by $3.1 million exclusive of the $2.6 million received in 2023 noted above. Cocrystal reported unrestricted cash as of December 31, 2024 of $9.9 million, compared with $26.4 million as of December 31, 2023. Net cash used in operating activities for 2024 was $16.5 million, compared with $14.7 million for 2023. The Company had working capital of $9.2 million and 10.2 million common shares outstanding as of December 31, 2024. About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. For further information about Cocrystal, please visit www.cocrystalpharma.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical product candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including preparation, commencement and advancement of clinical studies for certain product candidates in 2025, our plans regarding further clinical development of such product candidates, and the viability and efficacy of potential treatments for diseases our product candidates are designed to treat, and expectations for the markets for certain therapeutics. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from our need for additional capital to fund our operations over the next 12 months, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies for CC-42344 and CDI-988 including the delay of the Phase 2a study for CC-42344 which may require us to incur substantial additional costs, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes including potential downward pressure on government spending on the biopharmaceutical and healthcare industry based on policies and actions taken by the Trump Administration in the U.S., the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, and the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Investor Contact:Alliance Advisors IRJody Cain310-691-7100jcain@allianceadvisors.com Financial Tables to follow COCRYSTAL PHARMA, INC. CONSOLIDATED BALANCE SHEETS(in thousands) December 31, 2024 December 31, 2023 Assets Current assets: Cash $9,860 $26,353 Restricted cash 75 75 Tax credit receivable 1,215 890 Prepaid expenses and other current assets 430 1,773 Total current assets 11,580 29,091 Property and equipment, net 153 271 Deposits 29 46 Operating lease right-of-use assets, net (including $152 and $42 to related party) 1,694 1,851 Total assets $13,456 $31,259 Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses $2,127 $3,022 Current maturities of operating lease liabilities (including $49 and $42 to related party) 301 240 Total current liabilities 2,428 3,262 Long-term liabilities: Operating lease liabilities (including $104 and $0 to related party) 1,505 1,613 Total long-term liabilities 1,505 1,613 Total liabilities 3,933 4,875 Commitments and contingencies Stockholders’ equity: Common stock $0.001 par value; 100,000 and 150,000 shares authorized as of December 31, 2024 and 2023, respectively; 10,174 shares issued and outstanding as of December 31, 2024 and 2023, respectively 10 10 Additional paid-in capital 342,931 342,288 Accumulated deficit (333,418) (315,914)Total stockholders’ equity 9,523 26,384 Total liabilities and stockholders’ equity $13,456 $31,259 COCRYSTAL PHARMA, INC. CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited)(in thousands, except per share data) December 31, 2024 2023 Operating expenses: Research and development $12,537 $15,169 General and administrative 5,341 5,990 Legal settlement - (2,600)Total operating expenses 17,878 18,559 Loss from operations (17,878) (18,559) Other income (expense): Interest income, net 537 640 Foreign exchange loss (163) (65)Total other income, net 374 575 Net loss $(17,504) $(17,984) Net loss per common share, basic and diluted $(1.72) $(1.87)Weighted average number of common shares outstanding, basic and diluted 10,174 9,651 # # #

For the first time, Thompson shares his journey living with gastroesophageal reflux disease (GERD) and experience using VOQUEZNA, as part of the new GERD IS NO JOKE campaignVOQUEZNA is a potassium competitive acid blocker (PCAB), the first and only FDA-approved treatment of its kind for both types of GERD1 A Media Snippet accompanying this announcement is available by clicking on this link. FLORHAM PARK, N.J., March 31, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today a partnership with actor, comedian, and author Kenan Thompson, best known as the longest-running cast member on Saturday Night Live. For the first time ever, Thompson is publicly speaking out about his experience with GERD as part of the GERD IS NO JOKE campaign to raise awareness about the condition and encourage others to talk with their doctor about treatment options. Thompson, who has been diagnosed with the most common form of GERD, called Non-Erosive GERD, found heartburn relief with VOQUEZNA® (vonoprazan) after struggling with other treatments. VOQUEZNA is the first and only treatment of its kind approved by the U.S. Food and Drug Administration (FDA) to help manage his condition.1 VOQUEZNA is approved for use in adults for the relief of heartburn associated with Non-Erosive GERD and for the treatment of all severities of Erosive Esophagitis, commonly referred to as Erosive GERD, and relief of related heartburn.1 As one of more than 65 million people in the U.S. living with GERD2—a chronic condition where stomach acid flows into the esophagus, causing irritation and heartburn3—Thompson knows firsthand how disruptive symptoms can be. His goal is to help elevate the discussion around GERD and help others recognize the importance of finding an effective treatment to better manage their disease. “This is the first time I’m sharing my story with GERD, and trust me—it's no joke,” said Thompson. “I’ve dealt with terrible burning in my chest, avoided some of my favorite foods, and even had my heartburn affect my voice and sleep, which is tough when your job is to make people laugh. After struggling with treatments that didn’t work, my doctor recommended VOQUEZNA, and it helped me kick some acid and reduce my heartburn! I’m excited to partner with Phathom to encourage others to talk to their doctor and find the right treatment for them.” While Thompson has not experienced side effects while taking VOQUEZNA, some patients taking VOQUEZNA do. The most common side effects of VOQUEZNA for the relief of heartburn related to Non-Erosive GERD include stomach pain, constipation, diarrhea, nausea, and urinary tract infection.1 Please see additional Important Safety Information below. Thompson shares more about his personal story with GERD at GERDIsNoJoke.com, including a downloadable guide from his own unique point of view, and helpful tips for people to talk to their doctor about the condition. “Despite using over-the-counter medications and prescription treatments like antacids, histamine-2 receptor antagonists, or proton pump inhibitors—also called PPIs—many people with GERD continue to experience persistent, bothersome symptoms which could affect their daily lives,” said Kavita Kongara, M.D., Motility Clinical Chair and Georgia Physician Executive Committee Member, United Digestive, Physician, Atlanta Gastroenterology Associates. “It’s crucial that patients engage in open, honest conversations with their healthcare providers to explore all available therapeutic approaches. VOQUEZNA, a first-in-class PCAB, works differently than traditional medications and provides rapid and durable acid suppression, resulting in effective relief from heartburn and making it an important and differentiated option for GERD management.” As part of the campaign, Thompson is also taking on the comedic role of a chef in a “Kick Some Acid Cooking Show," a humorous nod to how VOQUEZNA has helped him better control his GERD-related heartburn. This multi-channel campaign will feature a new commercial airing next month on broadcast television and streaming platforms—including Prime Video, Hulu, and Peacock—and will also extend across digital platforms such as Facebook and Instagram, and in waiting rooms at doctors’ offices. The goal of the light-hearted campaign is to empower individuals experiencing persistent heartburn to consult their healthcare providers. “Phathom is passionate about supporting the millions of patients living with GERD and working to advance innovative treatments to address unmet needs," said Martin Gilligan, Chief Commercial Officer at Phathom. “We are excited to partner with Kenan Thompson, who has been making audiences laugh and feel good for decades. Kenan's story is inspiring and relatable to so many GERD sufferers. By sharing his journey for the first time, he’s helping to spark conversations and encourage others to talk to their doctors about VOQUEZNA.” To learn more about Thompson’s story, tips for discussing GERD with your healthcare provider, and VOQUEZNA as a treatment option, visit GERDIsNoJoke.com. A Media Snippet accompanying this announcement is available by clicking on this link. INDICATION AND IMPORTANT SAFETY INFORMATION What is VOQUEZNA? VOQUEZNA® (vonoprazan) is a prescription medicine used in adults: for 8 weeks to heal acid-related damage to the lining of the esophagus (called Erosive Esophagitis) and for relief of heartburn related to Erosive Esophagitis.for up to 6 months to maintain healing of Erosive Esophagitis and for relief of heartburn related to Erosive Esophagitis.for 4 weeks for relief of heartburn related to gastroesophageal reflux disease (GERD). It is not known if VOQUEZNA is safe and effective in children. Do not take VOQUEZNA if you: are allergic to vonoprazan or any of the other ingredients in VOQUEZNA. Allergic reaction symptoms may include trouble breathing, rash, itching, and swelling of your face, lips, tongue or throat.are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus). Before taking VOQUEZNA, tell your healthcare provider about all your medical conditions, including if you: have low magnesium, calcium, or potassium in your blood, or you are taking a medicine to increase urine (diuretic).have kidney or liver problems.are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if VOQUEZNA will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if VOQUEZNA passes into your breast milk. You and your healthcare provider should decide if you will take VOQUEZNA or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. VOQUEZNA may affect how other medicines work, and other medicines may affect how VOQUEZNA works. Especially tell your healthcare provider if you take medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSEY). What are the possible side effects of VOQUEZNA? VOQUEZNA may cause serious side effects including: A type of kidney problem (acute tubulointerstitial nephritis): Some people who take VOQUEZNA may develop a kidney problem called acute tubulointerstitial nephritis. Call your healthcare provider right away if you have a decrease in the amount that you urinate or if you notice blood in your urine.Diarrhea caused by an infection (Clostridioides difficile) in your intestines: Call your healthcare provider right away if you have watery stools, stomach pain, and fever that does not go away.Bone fractures (hip, wrist, or spine): Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long period of time (a year or longer). Tell your healthcare provider if you have a bone fracture, especially in the hip, wrist, or spine.Severe skin reactions: VOQUEZNA can cause rare, but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening: Skin rash which may have blistering, peeling, or bleeding on any part of your skin.You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes. If you experience any of these symptoms, stop taking VOQUEZNA and call your healthcare provider right away. These symptoms may be the first sign of a severe skin reaction. Low vitamin B-12 levels: VOQUEZNA lowers the amount of acid in your stomach. Stomach acid is needed to absorb Vitamin B12 properly. Tell your healthcare provider if you have symptoms of low vitamin B12 levels, including irregular heartbeat, shortness of breath, lightheadedness, tingling or numbness in the arms or legs, muscle weakness, pale skin, feeling tired, or mood changes. Talk with your healthcare provider about the risk of low vitamin B12 levels if you have been on VOQUEZNA for a long time.Low magnesium levels in the body can happen in people who take VOQUEZNA. Tell your healthcare provider right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, or spasms of the hands, feet, or voice.Stomach growths (fundic gland polyps): A certain type of stomach growth called fundic gland polyps may happen in people who take another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long time. Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time. The most common side effects of VOQUEZNA for treatment of Erosive Esophagitis and/or relief of heartburn related to gastroesophageal reflux disease include: • stomach inflammation• indigestion• diarrhea• constipation• stomach bloating• high blood pressure• stomach pain• urinary tract infection• nausea These are not all the possible side effects of VOQUEZNA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You are encouraged to report suspected adverse reactions by contacting Phathom Pharmaceuticals at 1-888-775-PHAT (7428) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see Patient Information and full Prescribing Information for VOQUEZNA. About Erosive and Non-Erosive Gastroesophageal Reflux Disease (GERD)Erosive GERD, also referred to as Erosive Esophagitis (EE), is a subtype of gastroesophageal reflux disease (GERD) characterized by erosions in the gastric mucosa caused by acidic reflux of stomach contents into the esophagus.4 There are estimated to be over 65 million individuals with GERD in the U.S.,2 of which approximately 30% have Erosive GERD.3 In addition to experiencing troubling symptoms including heartburn, patients with inadequately treated Erosive GERD may progress to more severe diseases including Barrett’s esophagus and esophageal cancer.5 Non-Erosive GERD is the largest category of GERD and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions.3 It is estimated that approximately 70% of the overall GERD population have Non-Erosive GERD.3 Symptoms of Non-Erosive GERD may impact overall quality of life and can include episodic heartburn, especially at night, regurgitation, problems swallowing, and chest pain.2,3 About VOQUEZNA®VOQUEZNA® (vonoprazan) tablets contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). PCABs are a novel class of medicines that block acid secretion in the stomach. VOQUEZNA is approved in the U.S. for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD, the relief of heartburn associated with Erosive GERD, the relief of heartburn associated with Non-Erosive GERD, and for the treatment of H. pylori infection in combination with either amoxicillin or amoxicillin and clarithromycin. Phathom in-licensed the U.S. rights to vonoprazan from Takeda, which markets the product in Japan and numerous other countries in Asia and Latin America. About Phathom Pharmaceuticals, Inc.Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, in addition to VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company’s website at www.phathompharma.com and follow on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the Company’s estimates of the number of patients with GERD. 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: the Company’s estimates regarding patient population could prove to be inaccurate 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 most recent 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. References VOQUEZNA. Prescribing Information. Phathom Pharmaceuticals; 2024.Machicado JD, Greer JB, Yadav D. (2021) Epidemiology of Gastrointestinal Diseases. In: Pitchumoni CS, Dharmarajan T, (eds). Geriatric Gastroenterology. Springer, Cham. https://doi.org/10.1007/978-3-030-30192-7_7Antunes C, Aleem A, Curtis SA. Gastroesophageal reflux disease. NCBI Bookshelf. Accessed January 21, 2024. Available at: https://www.ncbi.nlm.nih.gov/books/NBK441938/?report=printableDickman R, Maradey-Romero C, Gingold-Belfer R, Fass R. Unmet Needs in the Treatment of Gastroesophageal Reflux Disease. J Neurogastroenterol Motil. 2015 Jul 30;21(3):309-19. doi: 10.5056/jnm15105. Savarino E, de Bortoli N, De Cassan C, et al. The natural history of gastro-esophageal reflux disease: A comprehensive review. Dis Esophagus. 2017;30(2):1-9. MEDIA CONTACTNick Benedetto1-877-742-8466media@phathompharma.com INVESTOR CONTACTEric Sciorilli1-877-742-8466ir@phathompharma.com © 2025 Phathom Pharmaceuticals. All rights reserved. VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc. 03/25US-VPZ-24-0652

FRIDAY, March 14, 2025 -- COVID-19 vaccination in early pregnancy (≤20 weeks of gestation) is not associated with increased prevalence of major structural birth defects, according to a study published online March 14 in Pediatrics . Stacey L. Rowe, Ph.D., M.P.H., from the University of San Francisco, and colleagues compared the prevalence of major structural birth defects by COVID-19 vaccination status and compared the prevalence by brand (Moderna mRNA-1273 versus Pfizer-BioNTech BNT162b2) in a claims-based cohort study. Pregnancies ending in a live birth were captured among people with an estimated last menstrual period between Aug. 15, 2021, and Dec. 24, 2021. The researchers identified 1,248 major structural birth defects among 78,052 pregnancies: 1,049 in unvaccinated people and 199 in vaccinated people (160.6 and 156.4 per 10,000 live births, respectively). There were no significant differences in the prevalence of major structural birth defects based on COVID-19 vaccination status. No change was seen in the findings by insurance provider, severe acute respiratory syndrome coronavirus 2 infection during pregnancy, or concomitant administration of other maternal vaccines. Among vaccinated people, no differences were seen in the prevalence of birth defects by brand. "Our findings align with other comparable studies and provide reassurance to potential vaccinees and vaccine providers considering COVID-19 vaccination early in pregnancy," the authors write. Two authors disclosed ties to pharmaceutical companies, including Moderna and Pfizer. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.