Full Press Release Details
Phathom Pharmaceuticals Reports Third Quarter 2020 Results and Provides Update on Phase 3 Trials
Florham Park, N.J., November 10,
2020 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 third quarter of 2020 and provided an update of its ongoing pivotal Phase 3 trials for vonoprazan.
We are very pleased with the progress made
in the third quarter, especially the robust activity across our trial sites. We expect to complete patient enrollment in both of our Phase 3 trials in the coming months despite the ongoing COVID-19
pandemic, said Terrie Curran, President and Chief Executive Officer of Phathom Pharmaceuticals. We continue to build an impressive commercial and medical organization to lay the foundation for the potential launch of vonoprazan. With
topline data for both the PHALCON-EE and PHALCON-HP pivotal Phase 3 studies expected in 2021, our teams are executing on our key strategic imperatives to advance the
treatment of acid-related disorders.
PHALCON-EE and PHALCON-HP
Clinical Trial Updates:
Third Quarter 2020 Financial Results:
Recent Business Updates:
Planned Virtual Phathom Investor Day:
Phathom will host a virtual Investor Day on December 14, 2020 from 1 pm to 3:30 pm Eastern Time. Members of Phathom s management team and
gastroenterology key opinion leaders will provide updates on the company s pipeline and commercial strategy.
A subsequent press release with
detailed event information will be shared in the coming weeks and will also be posted on the News & Events section of the Phathom website at www.investors.phathompharma.com. A replay of the webcast will also be available and archived
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 U.S. Food and Drug Administration (FDA) has designated as a qualified infectious disease product (QIDP) and awarded Fast Track status to vonoprazan for the treatment of H. pylori infection in combination with both amoxicillin
and clarithromycin and with amoxicillin alone. 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 13 countries in Asia and Latin America.
PHALCON-EE is a randomized, double-blind, two-phase, multicenter Phase 3 trial
that is planned to enroll approximately 1,000 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.
PHALCON-HP is a randomized, multicenter, Phase 3 trial that is planned to enroll approximately 975 patients with H.
pylori infection in the U.S. and Europe. Participants are being randomized 1:1:1 to one of three arms: vonoprazan 20 mg administered twice a day (BID) and amoxicillin 1g administered three times a day (TID); vonoprazan 20 mg BID, amoxicillin 1 g
BID and clarithromycin 500 mg BID; and lansoprazole 30 mg BID, amoxicillin 1 g BID and clarithromycin 500 mg BID. Each treatment regimen is being administered for 14 days. PHALCON-HP is evaluating the
percentage of patients with successful eradication of H. pylori infection.
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 LinkedIn at
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 when the company expects to complete enrollment of patients in its PHALCON-EE and PHALCON-HP Phase 3 clinical trials; the expected availability of topline results from the PHALCON-EE and PHALCON-HP Phase 3 clinical trials; the company s expected cash runway; and the potential to receive regulatory and exclusivity benefits as a result of QIDP and Fast Track designations. 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 rate of patient enrollment in PHALCON-EE and PHALCON-HP due to the
COVID-19 pandemic is highly uncertain due to factors outside our control; potential additional delays in the commencement, enrollment and completion of clinical trials; patients already enrolled in PHALCON-EE and PHALCON-HP may not complete the clinical trials or public health conditions and governmental restrictions may lead us to stopping such trials all together,
which may adversely impact our trial results and development plans; our 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
not actually lead to a faster development or regulatory review or extended exclusivity, and would not assure FDA approval of vonoprazan; our ability to obtain and maintain intellectual property protection for vonoprazan; our ability to comply with
our license agreement with Takeda; our ability to maintain undisrupted business operations due to the ongoing spread of the COVID-19 coronavirus, including delaying or otherwise disrupting our 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.
Statements of Operations and Comprehensive Loss
thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (includes related party amounts of $1,023, $207, $1,676, and $207 respectively) | $ | 25,770 | $ | 4,469 | $ | 56,494 | $ | 7,670 | ||||||||
| In-process research and development | 78,897 | |||||||||||||||
| General and administrative (includes related party amounts of $62, $156, $139, and $174, respectively) | 7,060 | 1,813 | 16,732 | 3,955 | ||||||||||||
| Total operating expenses | 32,830 | 6,282 | 73,226 | 90,522 | ||||||||||||
| Loss from operations | (32,830 | ) | (6,282 | ) | (73,226 | ) | (90,522 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 15 | 429 | 1,075 | 530 | ||||||||||||
| Interest expense (includes related party amounts of $0, $(302), $0 and $(498), respectively) | (1,286 | ) | (1,990 | ) | (3,286 | ) | (3,138 | ) | ||||||||
| Change in fair value of warrant liabilities (includes related party amounts of $0, $(57,754), $0 and $(59,031), respectively) | (57,776 | ) | 95 | (59,060 | ) | |||||||||||
| Change in fair value of convertible promissory notes (includes related party amounts of $0, $(732), $0, and $(1,053), respectively) | (2,486 | ) | (4,928 | ) | ||||||||||||
| Other income (expense) | (4 | ) | (7 | ) | (5 | ) | (7 | ) | ||||||||
| Total other income (expense) | (1,275 | ) | (61,830 | ) | (2,121 | ) | (66,603 | ) | ||||||||
| Net loss | $ | (34,105 | ) | $ | (68,112 | ) | $ | (75,347 | ) | $ | (157,125 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.02 | ) | $ | (9.30 | ) | $ | (2.29 | ) | $ | (22.87 | ) | ||||
| Weighted-average shares of common stock outstanding, basic and diluted | 33,366,237 | 7,326,090 | 32,946,128 | 6,871,471 |
PHATHOM PHARMACEUTICALS, INC.
thousands, except share and par value amounts)
| September 30, 2020 | December 31, 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 226,361 | $ | 243,765 | ||||
| Prepaid expenses and other current assets | 800 | 11,836 | ||||||
| Total current assets | 227,161 | 255,601 | ||||||
| Property, plant and equipment, net | 862 | 463 | ||||||
| Operating lease right-of-use assets | 2,485 | 933 | ||||||
| Other long-term assets | 381 | 181 | ||||||
| Total assets | $ | 230,889 | $ | 257,178 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable (including related party amounts of $331 and $200, respectively) | $ | 4,788 | $ | 699 | ||||
| Accrued expenses (including related party amounts of $415 and $308, respectively) | 16,593 | 2,319 | ||||||
| Accrued interest | 302 | 156 | ||||||
| Current portion of long-term debt | 5,556 | |||||||
| Operating lease liabilities, current | 431 | 161 | ||||||
| Warrant liabilities | 413 | |||||||
| Total current liabilities | 27,670 | 3,748 | ||||||
| Long-term debt, net of discount | 41,062 | 22,777 | ||||||
| Operating lease liabilities | 1,644 | 635 | ||||||
| Other long-term liabilities | 4,125 | 2,063 | ||||||
| Total liabilities | 74,501 | 29,223 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Common stock, $0.0001 par value; authorized shares 400,000,000; issued shares 28,964,506; outstanding shares 25,916,093 at September 30, 2020 and 24,728,258 at December 31, 2019, respectively | 3 | 2 | ||||||
| Additional paid-in capital | 488,151 | 484,372 | ||||||
| Accumulated deficit | (331,766 | ) | (256,419 | ) | ||||
| Total stockholders equity | 156,388 | 227,955 | ||||||
| Total liabilities and stockholders equity | $ | 230,889 | $ | 257,178 |