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:
- On May 3, 2022, Phathom announced the FDA approval of VOQUEZNA
TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA
DUAL PAK (vonoprazan, amoxicillin) for the treatment of
Helicobacter pylori (H. pylori) infection in adults. These VOQUEZNA
treatment regimens contain antibiotics conveniently packaged with
vonoprazan, a novel potassium-competitive acid blocker (PCAB) and
the first innovative acid suppressant from a new drug class
approved in the U.S. in over 30 years. The two New Drug
Applications for these products were given priority review
designation by the FDA and were previously designated as qualified
infectious disease products (QIDP). A U.S. commercial launch is
anticipated for the third quarter of 2022.
- Phathom announced positive topline results from a Phase 2 trial
evaluating vonoprazan for non-erosive gastroesophageal reflux
disease (NERD). The primary endpoint was met for all three dose
levels (10 mg, 20 mg, 40 mg) taken on-demand in the trial,
demonstrating faster and sustained relief of episodic heartburn as
compared to placebo (p<0.0001).
- Based on input from the FDA, Phathom commenced a Phase 3 NERD
development program in the first quarter of 2022 with the
initiation of a pivotal Phase 3 vonoprazan daily dosing trial
(NERD-301). The trial is actively recruiting across the U.S. with
topline results expected in 2023.
- Phathom is currently designing a Phase 3 study to support the
novel dosing regimen for vonoprazan as an on-demand treatment for
episodic heartburn relief in patients with NERD, a dosing regimen
not approved in the U.S. for proton pump inhibitors (PPIs). Pending
FDA input, we expect to initiate the NERD Phase 3 on-demand trial
(NERD-302) in 2023.
Recent Financial and Business Updates:
- Phathom announced the signing of a revenue interest financing
agreement for up to $260 million in non-dilutive financing on May
4, 2022. The agreement provides for an upfront $100 million cash
payment and an additional $160 million cash payment upon FDA
approval of vonoprazan for treatment of erosive esophagitis (EE).
The company has an option, upon the same terms, to obtain an
additional $15 million in funding upon EE approval and an
additional cash payment up to $25 million upon achievement of a
sales milestone, which could bring the total financing to $300
million. Under the agreement, the company will pay the investors a
10% royalty on net sales of products containing vonoprazan, which
royalty rate is subject to a step-down on net sales exceeding
annual thresholds if the company receives approval of vonoprazan
for NERD. Based upon the company’s current operating plan, the full
amount of this non-dilutive funding, in combination with existing
cash and a full drawdown of funds under the loan agreement with
Hercules Capital and anticipated future sales of products
containing vonoprazan, the company believes it will have sufficient
capital to fund operations through 2024, which includes supporting
the launch of vonoprazan in both H. pylori and EE (if approved) in
addition to completing its daily dosing Phase 3 trial in NERD.
- During Digestive Disease Week® (DDW) 2022, to be held May 21-24
in San Diego, CA and virtually, Phathom will have a large presence
including showcasing new data for vonoprazan. An analysis of H.
pylori diagnosis and treatment patterns will be presented, among
other important clinical developments. Several abstracts being
presented during DDW have been recognized as “posters of
distinction” by the American Gastroenterological Association (AGA)
Institute.
- Phathom announced the strengthening
of its company leadership with the appointments of Molly Henderson
as Chief Financial and Business Officer and Frank Karbe to its
Board of Directors. Ms. Henderson most recently served as Chief
Financial Officer of UroGen Pharma (Nasdaq: URGN) and brings over
two decades of global finance expertise and has extensive
experience in financial planning and analysis, investor relations,
and capital raising. Mr. Karbe, who most recently served as
President and Chief Financial Officer of Myovant Sciences (NYSE:
MYOV) brings over twenty-five years of financial and life-sciences
expertise to Phathom.
First Quarter 2022 Financial Results:
- Research and development expenses
for the first quarter ended March 31, 2022 decreased to $17.7
million compared to $20.6 million for first quarter 2021 as a
result of lower clinical trial costs related to the development of
vonoprazan. The first quarter of 2021 included activity relating to
two pivotal Phase 3 trials which supported the recent approval of
vonoprazan-based regimens in H. pylori infection and the NDA
submission for vonoprazan in EE. Non-cash stock compensation
expense included within research and development expenses for the
first quarter ended 2022 and 2021 was $1.1 million and $0.9
million, respectively.
- General and administrative expenses
for the first quarter ended March 31, 2022 increased to $20.2
million compared to $13.0 million for first quarter 2021 primarily
due to the ongoing buildout of the commercial organization in
support of the planned U.S. launch of VOQUEZNA TRIPLE and DUAL
PAKs, the company’s first FDA approved products in H. pylori
infection. Non-cash stock compensation expense included within
general and administrative expenses for the first quarter ended
2022 and 2021 was $4.6 million and $3.0 million, respectively.
- Net loss for the first quarter ended
March 31, 2022 was $40.7 million, compared to $34.8 million for
first quarter 2021.
- As of March 31, 2022, cash and cash
equivalents were $138.1 million plus an additional $150 million in
liquidity for which Phathom is eligible to receive, which includes
$100 million in proceeds from the revenue interest financing
agreement announced on May 4, 2022 and $50 million from its term
loan with Hercules Capital.
[Tables follow]
About VOQUEZNA TRIPLE and DUAL PAKsVOQUEZNA
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
InformationINDICATIONS 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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSVOQUEZNA TRIPLE 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).
Severe 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 appropriately.
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 tablets.
ADVERSE REACTIONSThe most common adverse
reactions (≥2%) include diarrhea, dysgeusia, vulvovaginal
candidiasis, abdominal pain, headache, hypertension, and
nasopharyngitis.
DRUG INTERACTIONSComponents 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 POPULATIONSLactation:
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 impairment.
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.
About DDWDigestive 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.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 StatementsPhathom 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
Nick Benedetto1-877-742-8466media@phathompharma.com
ir@phathompharma.com
© 2022 Phathom Pharmaceuticals. All rights reserved.
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.
Statements of Operations and Comprehensive Loss
(Unaudited)(in thousands, except share and
per share amounts)
|
|
Three Months
EndedMarch 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
(Unaudited)(in thousands)
|
|
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 |
|
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