Full Press Release Details
Phathom Pharmaceuticals Reports Second Quarter 2021 Results and Provides Update Regarding Key Clinical and Regulatory Milestones
Florham Park, N.J., August 10, 2021 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 second quarter of 2021 and provided an update on expected clinical and regulatory milestones.
Our execution against key priorities through the second quarter has advanced several critical catalysts which we expect will lay the foundation for
Phathom s long-term success, said Terrie Curran, Phathom s President and Chief Executive Officer. We continue to progress our GERD development programs, which have the potential to address the unmet needs in a population of
approximately 65 million people in the U.S. We are expecting topline data from our pivotal Phase 3 PHALCON-EE trial evaluating vonoprazan for erosive esophagitis (EE) in October 2021 and are now expecting
topline data from our Phase 2 PHALCON-NERD trial evaluating vonoprazan as on demand treatment for non-erosive reflux disease (NERD) in Q1 2022. Additionally, we are nearing the submission of new drug
applications (NDAs) to the FDA for both the dual and triple vonoprazan-based regimens for the treatment of H. pylori infection, now expected in September 2021. The anticipated progress over the next
several months will be key to advancing our mission of changing the landscape in gastrointestinal diseases.
Clinical Development and Regulatory
Second Quarter 2021 Financial Results:
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 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 Phathom Pharmaceuticals, Inc.
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 and the Phase 2 NERD on demand clinical trials; and the expected submission of New Drug
Applications for vonoprazan-based therapies for the eradication of H. pylori infection. 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 the Phase 2 NERD study may not complete the clinical
trial 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.
PHATHOM PHARMACEUTICALS, INC.
thousands, except share and par value amounts)
| June 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 209,669 | $ | 287,496 | ||||
| Prepaid expenses and other current assets (including related party amounts of $0 and $82, respectively) | 1,669 | 3,872 | ||||||
| Total current assets | 211,338 | 291,368 | ||||||
| Property, plant and equipment, net | 803 | 986 | ||||||
| Operating lease right-of-use assets | 2,147 | 2,373 | ||||||
| Other long-term assets | 291 | 384 | ||||||
| Total assets | $ | 214,579 | $ | 295,111 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable (including related party amounts of $124 and $173, respectively) | $ | 5,401 | $ | 16,782 | ||||
| Accrued clinical trial expenses | 14,238 | 19,997 | ||||||
| Accrued expenses (including related party amounts of $1,505 and $734, respectively) | 8,845 | 10,606 | ||||||
| Accrued interest | 302 | 312 | ||||||
| Current portion of long-term debt | 10,345 | 7,353 | ||||||
| Operating lease liabilities, current | 480 | 474 | ||||||
| Total current liabilities | 39,611 | 55,524 | ||||||
| Long-term debt, net of discount | 37,340 | 39,634 | ||||||
| Operating lease liabilities | 1,375 | 1,557 | ||||||
| Other long-term liabilities | 4,125 | 4,125 | ||||||
| Total liabilities | 82,451 | 100,840 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.0001 par value; authorized shares 40,000,000 at June 30, 2021 and December 31, 2020 ; no shares issued and outstanding at June 30, 2021 and December 31, 2020 | ||||||||
| Common stock, $0.0001 par value; authorized shares 400,000,000; issued shares 31,329,613 and 31,262,769 at June 30, 2021 and December 31, 2020, respectively; outstanding shares 29,186,169 and 28,516,010 at June 30, 2021 and December 31, 2020, respectively | 3 | 3 | ||||||
| Additional paid-in capital | 589,007 | 579,755 | ||||||
| Accumulated deficit | (456,882 | ) | (385,487 | ) | ||||
| Total stockholders equity | 132,128 | 194,271 | ||||||
| Total liabilities and stockholders equity | $ | 214,579 | $ | 295,111 |
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, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (includes related party amounts of $905, $249, $1846, and $653, respectively) | $ | 21,597 | $ | 14,859 | $ | 42,178 | $ | 30,724 | ||||||||
| General and administrative (includes related party amounts of $0, $34, $16, and $77, respectively) | 13,722 | 5,162 | 26,725 | 9,672 | ||||||||||||
| Total operating expenses | 35,319 | 20,021 | 68,903 | 40,396 | ||||||||||||
| Loss from operations | (35,319 | ) | (20,021 | ) | (68,903 | ) | (40,396 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 13 | 182 | 27 | 1,060 | ||||||||||||
| Interest expense | (1,256 | ) | (1,262 | ) | (2,528 | ) | (2,000 | ) | ||||||||
| Change in fair value of warrant liabilities | 95 | |||||||||||||||
| Other income (expense) | 10 | 9 | (1 | ) | ||||||||||||
| Total other income (expense) | (1,233 | ) | (1,080 | ) | (2,492 | ) | (846 | ) | ||||||||
| Net loss and comprehensive loss | $ | (36,552 | ) | $ | (21,101 | ) | $ | (71,395 | ) | $ | (41,242 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.00 | ) | $ | (0.64 | ) | $ | (1.96 | ) | $ | (1.26 | ) | ||||
| Weighted-average shares of common stock outstanding, basic and diluted | 36,636,164 | 32,997,099 | 36,468,498 | 32,733,750 |