Full Press Release Details
Phathom Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Updates
FLORHAM PARK, N.J., August 2, 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 second quarter of 2022 and provided recent
The second quarter of 2022 was pivotal for Phathom as our teams continued to achieve major milestones, including the approval of
our first products, the receipt of an earlier than expected PDUFA date for our EE NDA, and key progress in enrollment in our Phase 3 NERD trial, said Terrie Curran, President and Chief Executive Officer of Phathom. As the pharmaceutical
industry and global regulatory agencies continue to develop standards to help detect and control levels of nitrosamines, an impurity commonly found in water, meats, and vegetables, we detected trace levels of a nitrosamine in vonoprazan drug product
in our post-approval testing as we prepared for commercial launch. We will be discussing with the FDA a new test method and controls, and confirming our assessment that our drug product is within acceptable intake levels. Our goal is to make our
product available to H. pylori patients as soon as possible, however, we are now planning for a combined full commercial launch of both H. pylori and EE in the first quarter of 2023. We believe a combined launch will bring significant
operational and financial benefits.
Second Quarter and Recent Business Updates:
Second Quarter 2022 Financial
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 submitted a New Drug
Application to 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 Phase 3 trial; and our plans to address the trace levels of a nitrosamine impurity observed in vonoprazan drug
product for VOQUEZNA DUAL and TRIPLE PAK and to obtain FDA approval to enable commercial launch of these products. 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 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.
2022 Phathom Pharmaceuticals. All rights
VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks or trademarks
of Phathom Pharmaceuticals, Inc.
PHATHOM PHARMACEUTICALS, INC.
Selected Condensed Balance Sheets
| June 30, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 207,392 | $ | 183,259 | ||||
| Total assets | $ | 213,502 | $ | 189,431 | ||||
| Total liabilities | $ | 220,502 | $ | 117,275 | ||||
| Total stockholders equity (deficit) | $ | (7,000 | ) | $ | 72,156 |
PHATHOM PHARMACEUTICALS, INC.
Statements of Operations and Comprehensive Loss
thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (includes related party amounts of $370, $905, $1,800, and $1,846, respectively) | $ | 18,815 | $ | 21,597 | $ | 36,475 | $ | 42,178 | ||||||||
| General and administrative (includes related party amounts of $0, $0, $0, and $16, respectively) | 26,548 | 13,722 | 46,794 | 26,725 | ||||||||||||
| Total operating expenses | 45,363 | 35,319 | 83,269 | 68,903 | ||||||||||||
| Loss from operations | (45,363 | ) | (35,319 | ) | (83,269 | ) | (68,903 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 112 | 13 | 119 | 27 | ||||||||||||
| Interest expense | (5,667 | ) | (1,256 | ) | (8,426 | ) | (2,528 | ) | ||||||||
| Other (expense) | (2 | ) | 10 | (9 | ) | 9 | ||||||||||
| Total other (expense) | (5,557 | ) | (1,233 | ) | (8,316 | ) | (2,492 | ) | ||||||||
| Net loss and comprehensive loss | $ | (50,920 | ) | $ | (36,552 | ) | $ | (91,585 | ) | $ | (71,395 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.33 | ) | $ | (1.00 | ) | $ | (2.40 | ) | $ | (1.96 | ) | ||||
| Weighted-average shares of common stock outstanding, basic and diluted | 38,272,044 | 36,636,164 | 38,155,151 | 36,468,498 |