Full Press Release Details
Phathom Pharmaceuticals Reports First Quarter 2022 Results and Provides Recent
Clinical, Regulatory, and Business Updates
FLORHAM PARK, N.J., May 10, 2022 Phathom Pharmaceuticals, Inc.
(Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the first quarter of 2022 and provided updates on recent clinical, regulatory,
and business progress.
Phathom demonstrated strong execution on several key initiatives throughout the start of 2022, resulting in the
accomplishment of important regulatory and financial milestones that we believe provide the basis to achieve success for years to come, said Terrie Curran, President and Chief Executive Officer of Phathom. We were excited to receive the
company s first FDA approval of VOQUEZNA TRIPLE and DUAL PAKs in H. pylori infection, and our teams are working diligently to prepare for the planned launch of these innovative products in the third quarter of this year. Additionally,
the strengthening of our financial position with the recent signing of a royalty financing agreement provides us with a strong foundation to become the leading gastrointestinal-focused commercial pharmaceutical company.
Clinical and Regulatory Updates:
Recent Financial and Business Updates:
First Quarter 2022 Financial Results:
PHATHOM PHARMACEUTICALS, INC.
Statements of Operations and Comprehensive Loss
thousands, except share and per share amounts)
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Operating expenses: | ||||||||
| Research and development (includes related party amounts of $1,430 and $939 respectively) | $ | 17,660 | $ | 20,580 | ||||
| General and administrative (includes related party amounts of $0 and $16, respectively) | 20,246 | 13,004 | ||||||
| Total operating expenses | 37,906 | 33,584 | ||||||
| Loss from operations | (37,906 | ) | (33,584 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 7 | 14 | ||||||
| Interest expense | (2,759 | ) | (1,272 | ) | ||||
| Other (expense) | (7 | ) | (1 | ) | ||||
| Total other (expense) | (2,759 | ) | (1,259 | ) | ||||
| Net loss and comprehensive loss | $ | (40,665 | ) | $ | (34,843 | ) | ||
| Net loss per share, basic and diluted | $ | (1.07 | ) | $ | (0.96 | ) | ||
| Weighted-average shares of common stock outstanding, basic and diluted | 38,036,960 | 36,298,968 |
PHATHOM PHARMACEUTICALS, INC.
Selected Condensed Balance Sheets
| March 31, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 138,090 | $ | 183,259 | ||||
| Total assets | $ | 149,049 | $ | 189,431 | ||||
| Total liabilities | $ | 111,014 | $ | 117,275 | ||||
| Total stockholders equity | $ | 38,035 | $ | 72,156 |
About VOQUEZNA TRIPLE and DUAL PAKs
VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA DUAL PAK (vonoprazan, amoxicillin) contain vonoprazan, an oral small
molecule potassium-competitive acid blocker (PCAB) co-packaged with antibiotics. PCABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has shown the potential to
provide acid suppression that can achieve pH levels that are important in enhancing antibiotic effectiveness. 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.
Indication and Important Safety Information
INDICATIONS AND USAGE
VOQUEZNA TRIPLE PAK is a co-packaged product containing vonoprazan, a potassium-competitive acid blocker
(PCAB), amoxicillin, a penicillin-class antibacterial, and clarithromycin, a macrolide antimicrobial. VOQUEZNA DUAL PAK is a co-packaged product containing vonoprazan and amoxicillin. Both products are indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK and other antibacterial drugs,
both products should be used only to treat or prevent infections that are proven or strongly suspected of being caused by bacteria.
PAK and VOQUEZNA DUAL PAK are contraindicated in patients with known hypersensitivity to vonoprazan or amoxicillin, any other components of the formulation, any other beta-lactams, or in patients receiving rilpivirine-containing products.
Due to the clarithromycin component, VOQUEZNA TRIPLE PAK is also contraindicated in patients with any known hypersensitivity to clarithromycin or any
macrolide antibiotic, in patients receiving pimozide, lomitapide, lovastatin, simvastatin, ergotamine, dihydroergotamine, colchicine in patients with renal or hepatic impairment, or those with a history of cholestatic jaundice/hepatic dysfunction.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Serious and occasionally fatal reactions (e.g., anaphylaxis) have been reported with components of VOQUEZNA TRIPLE PAK and
VOQUEZNA DUAL PAK. If hypersensitivity reactions occur, discontinue use and institute immediate therapy (e.g., anaphylaxis management).
Cutaneous Adverse Reactions (SCAR): Discontinue use of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK at first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation. SCAR, including Stevens-Johnson syndrome (SJS)
and toxic epidermal necrolysis (TEN) have been reported with the components of both products. In addition, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with
amoxicillin and clarithromycin.
Clostridioides difficile-associated diarrhea (CDAD): Evaluate if diarrhea occurs with VOQUEZNA
TRIPLE PAK or VOQUEZNA DUAL PAK. CDAD has been reported with use of acid suppressing therapies and nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. If CDAD is confirmed, discontinue therapy and treat
VOQUEZNA TRIPLE PAK Warnings or Precautions Due to the Clarithromycin Component:
QT Prolongation: Avoid VOQUEZNA TRIPLE PAK in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular
arrhythmia (torsades de pointes), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics.
Hepatotoxicity: Discontinue use of VOQUEZNA TRIPLE PAK if signs and symptoms of hepatitis occur.
Serious adverse reactions due to concomitant use with other drugs: Serious adverse reactions can occur with VOQUEZNA TRIPLE PAK due to drug
interactions of clarithromycin with colchicine, some lipid lowering agents, some calcium channel blockers, hypoglycemic agents including insulin, quetiapine, warfarin, benzodiazepines, and other drugs.
Embryo-Fetal Toxicity: VOQUEZNA TRIPLE PAK is not recommended for use in pregnancy as clarithromycin may cause fetal harm.
Myasthenia Gravis: Exacerbation of myasthenia gravis can occur with VOQUEZNA TRIPLE PAK since it has been reported in patients receiving clarithromycin
The most common adverse
reactions ( 2%) include diarrhea, dysgeusia, vulvovaginal candidiasis, abdominal pain, headache, hypertension, and nasopharyngitis.
Components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK have the potential for clinically important drug interactions. See full
Prescribing Information for important drug interactions.
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding not recommended during treatment, but a lactating woman can pump and discard breast milk during treatment and for 2 days after
VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK administration.
Geriatrics: VOQUEZNA TRIPLE PAK increased risk of torsades de pointes due to clarithromycin.
Renal and Hepatic Impairment: Avoid use in patients with severe renal impairment and avoid use in patients with moderate to severe hepatic
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 full Prescribing Information for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK.
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by
the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT),
DDW is an in-person and virtual meeting from May 21-24, 2022. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI
research, medicine and technology. More information can be found at www.ddw.org.
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 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 our plans to launch vonoprazan-based therapies
for the treatment of H. pylori infection in the third quarter of 2022, the timing of topline results from our Phase 3 daily dosing trial for NERD and initiation of a Phase 3 on-demand dosing trial for
NERD, the availability of additional funds under our revenue interest financing agreement and loan agreement with Hercules Capital, and the sufficiency of our capital to fund the Company s operations. 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 inherent risks of clinical development of vonoprazan; 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; Phathom s ability to successfully launch and commercialize vonoprazan; 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 QIDP designations may not actually lead to extended exclusivity; 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 launch and commercialization efforts; Phathom s ability to achieve and maintain adequate levels of coverage and reimbursement for vonoprazan;
Phathom s ability to access additional capital under the term loan facility is subject to certain conditions; 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.
MEDIA AND INVESTOR CONTACT
VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks or trademarks of Phathom
Pharmaceuticals, Inc.