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FLORHAM PARK, N.J., Nov. 08, 2022 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the third quarter of 2022 and provided recent business updates.
“Phathom continued to make significant progress in the third quarter, including completing enrollment in our Phase 3 NERD daily dosing trial, and increasing the total amount potentially available under our royalty financing agreement to $300 million which will further fund our planned product launches and future vonoprazan development programs,” said Terrie Curran, President and Chief Executive Officer of Phathom. “Over the last several months we have developed and validated test methods for detecting the nitrosamine impurity discovered at trace levels in our drug product as reported in August and are in discussions with the FDA on our control limits in advance of bringing our novel products to market.” In addition, we are pleased with the progress our commercial and market access teams have made over the last quarter preparing for the anticipated first quarter 2023 launches of VOQUEZNA™ TRIPLE PAK™ and VOQUEZNA™ DUAL PAK™ as well as, if approved, VOQUEZNA™ tablets for EE.”
Third Quarter and Recent Business Updates:
Third Quarter 2022 Financial Results:
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 first-in-class potassium-competitive acid blocker (PCAB). Vonoprazan-based regimens are approved in the U.S. as part of a co-packaged product in combination with antibiotics for the treatment of H. pylori infection in adults, marketed as VOQUEZNA™ TRIPLE PAK™ (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA™ DUAL PAK™ (vonoprazan, amoxicillin). Phathom has a New Drug Application under review by the FDA for vonoprazan in erosive esophagitis (EE) and is studying the use of vonoprazan for the treatment of non-erosive reflux disease (NERD). For more information about Phathom, visit the Company’s website at www.phathompharma.com and follow the Company on LinkedIn and Twitter.
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 PDUFA target action date and potential approval of our EE NDA; our plans to launch vonoprazan for our H. pylori and EE indications and the timing thereof; the expected timing of topline data for the NERD daily dosing Phase 3 trial; and our plans to address the trace levels of a nitrosamine impurity observed in vonoprazan drug product for VOQUEZNA DUAL PAK and TRIPLE PAK and to obtain FDA approval to enable commercial launch of these products as well as VOQUEZNA, if approved, for EE. 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 FDA may disagree that the existing safety and efficacy data is sufficient to approve the EE NDA, including as a result of the trace levels of a nitrosamine impurity observed in commercial batches of vonoprazan drug product for VOQUEZNA DUAL PAK and TRIPLE PAK; the potential for the FDA to delay the PDUFA target action date related to the EE NDA due to the FDA’s internal resource constraints or other reasons; the inherent risks of clinical development of vonoprazan; Phathom’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; Phathom’s ability to successfully address the formation of nitrosamine impurities in commercial batches of vonoprazan drug product and gaining FDA approval of any such resolution including the applicable acceptable daily intake limit; 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 ability to access additional capital under its term loan facility and royalty interest finance agreements is subject to certain conditions; 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.
Selected Condensed Balance Sheets
|Cash and cash equivalents||$||196,838||$||183,259|
|Total stockholders’ equity (deficit)||$||(26,423)||$||72,156|
PHATHOM PHARMACEUTICALS, INC.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
|Three Months Ended
|Nine Months Ended
|Research and development (includes related party amounts of $77, $849, $1,800, and $2,695, respectively)||$||19,020||$||16,608||$||55,495||$||58,786|
|General and administrative (includes related party amounts of $0, $0, $0, and $16, respectively)||23,509||16,529||70,303||43,254|
|Total operating expenses||42,529||33,137||125,798||102,040|
|Loss from operations||(42,529||)||(33,137||)||(125,798||)||(102,040||)|
|Other income (expense):|
|Total other expense||(8,562||)||(3,525||)||(16,878||)||(6,017||)|
|Net loss and comprehensive loss||$||(51,091||)||$||(36,662||)||$||(142,676||)||$||(108,057||)|
|Net loss per share, basic and diluted||$||(1.32||)||$||(0.98||)||$||(3.72||)||$||(2.94||)|
|Weighted-average shares of common stock outstanding, basic and diluted||38,820,266||37,299,351||38,379,292||36,748,492|
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VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks or trademarks of Phathom Pharmaceuticals, Inc.