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Phathom Pharmaceuticals
Reports First Quarter 2023 Results
2023-05-10
·
BioSpace
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FLORHAM PARK, N.J., May 10, 2023 (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 first quarter of 2023 and provided updates on recent regulatory progress. “This quarter, we made remarkable progress advancing mission-critical priorities that position
Phathom
to potentially deliver
vonoprazan
to patients suffering from
Erosive GERD
and
H. pylori infection
before year end,” said Terrie Curran, President and Chief Executive Officer of
Phathom
. “Our ongoing stability program for the minor drug product reformulation continues to demonstrate effective control of the N-nitroso-vonoprazan (NVP) impurity and confirms our confidence that our planned NDA resubmission will address the sole deficiency cited in the FDA’s complete response letters. Building on this positive momentum, our commercial team continues to prepare for a planned fourth quarter commercial launch and we remain engaged with payers, healthcare providers, and key opinion leaders to capitalize on the blockbuster potential of our first-in-class therapy.” Clinical, Regulatory, and Business Updates:
Phathom
remains on track to resubmit its
erosive esophagitis (Erosive GERD)
NDA this quarter, with potential for FDA approval and a subsequent U.S. commercial launch for
Erosive GERD
and
H. pylori infection
anticipated in the fourth quarter of 2023. The Company’s ongoing stability program for the minor reformulation of
vonoprazan
drug product continues to demonstrate that it is achieving the intended effects of limiting and controlling
NVP
formation. Based on FDA feedback from the March 2023 meeting,
Phathom
believes the data package it expects to include in the resubmission will address the
NVP
issue, the sole deficiency noted in the FDA’s complete response letters (CRLs). In January 2023,
Phathom
shared positive topline results from the Phase 3 PHALCON-NERD-301 trial evaluating the daily dosing of
vonoprazan
for
Non-Erosive GERD
. Both
vonoprazan
10 mg and 20 mg doses met the primary endpoint and showed highly statistically significant greater percentage of 24-hour
heartburn
free days as compared to placebo (p<0.0001). The blinded 20-week long-term extension period of the trial is proceeding as planned and a regulatory submission is expected for the second half of 2023 seeking approval of
vonoprazan
as a daily (QD) treatment for
Non-Erosive GERD
, the largest subcategory of
GERD
with an estimated U.S. patient population of over 45 million people.
Phathom
has currently secured coverage for 60% of commercial lives for first-in-class
H. pylori infection
treatments
VOQUEZNA
® TRIPLE PAK® and
VOQUEZNA
® DUAL PAK®. New data from two post-hoc analyses were presented in poster presentations during
Digestive Disease
Week® (DDW) 2023, held May 6-9 in person in Chicago, IL and virtually: Higher eradication rates of
H. pylori infection
were demonstrated with
vonoprazan
-based regimens vs.
lansoprazole
triple therapy, regardless of different baseline demographics and clinical characteristics. A meta-analysis showed that
potassium-competitor acid blockers (PCABs)
, including
vonoprazan
, provide a longer duration of pH >4, higher predicted
Erosive GERD
healing rates, and lower probabilities of failure to achieve healing, as compared to histamine2–receptor antagonists (H2RAs) and
proton pump inhibitors (PPIs)
. First Quarter 2023 Financial Results: Net loss for the first quarter ended March 31, 2023 was $37.8 million, compared to $40.7 million for first quarter 2022. First quarter 2023 net loss included a non-cash charge related to stock-based compensation of $7.0 million compared to $5.8 million for first quarter 2022. Operating expenses for the first quarter 2023 were 36% lower than the preceding quarter, primarily due to cost control measures enacted as a result of the delayed commercial launch of VOQUEZNA TRIPLE PAK and DUAL PAK for
H. pylori infection
, and, if approved, VOQUEZNA for
Erosive GERD
. Research and development expenses for the first quarter 2023 were $11.5 million, a decrease of $6.2 million compared to $17.7 million for first quarter 2022. The decrease was a result of decreased clinical trial costs and chemistry, manufacturing and controls costs, partially offset by increased personnel costs. General and administrative expenses for the first quarter 2023 were $18.6 million, a decrease of $1.6 million compared to $20.2 million for first quarter 2022. The decrease was primarily due to a reduction in professional services partially offset by increased personnel costs. As of March 31, 2023, cash and cash equivalents were $129.6 million. An additional $100.0 million is available under
Phathom
’s term loan with Hercules Capital and $175.0 million becomes available to
Phathom
upon FDA approval of
VOQUEZNA
for
Erosive GERD
under the terms of our revenue interest financing agreement. Based on its current operating plan, including the funds currently available under our existing term loan and cash available under our royalty interest financing agreement following approval of VOQUEZNA for
Erosive GERD
,
Phathom
believes it will have sufficient capital to fund operations through the end of 2024. About
Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals
is a biopharmaceutical company focused on the development and commercialization of novel treatments for
gastrointestinal diseases
.
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). For more information about
Phathom
, visit the Company’s website at 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
Phathom
’s expectations of generating stability data necessary to support the proposed shelf life of
vonoprazan
; the expected timing of resubmission of the
Erosive GERD
NDA; the potential approval of its
Erosive GERD
NDA and post approval supplements for its H. pylori NDAs, and anticipated product launches in H. pylori and
Erosive GERD
; and that
Phathom
will have sufficient capital to fund operations through the end of 2024. 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:
Phathom
may be unable to generate the required data to meet the acceptable intake of its nitrosamine impurity, or may be unable to reduce the impurity to an acceptable level throughout the shelf life of the product, to obtain approval its
Erosive GERD
NDA or to bring
vonoprazan
to market for patients with
Erosive GERD
, if approved, or for patients with H. pylori; future nitrosamine data may be inconsistent with data generated to date; the FDA may not accept for review the Erosive GERD NDA even after we have submitted the NDA; risks associated with product manufacturing or formulation changes required to be made in connection with achieving the acceptable daily intake limit of the nitrosamine detected in vonoprazan drug product; the FDA may disagree that the existing safety and efficacy data, together with additional data, is sufficient to approve the erosive esophagitis NDA or supplements to the H. pylori NDAs; 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; 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
; 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 CONTACT Nick Benedetto 1-877-742-8466 media@phathompharma.com INVESTOR CONTACT Eric Sciorilli 1-877-742-8466 ir@phathompharma.com © 2023
Phathom Pharmaceuticals
. All rights reserved. Selected Condensed Balance Sheets (Unaudited) (in thousands) March 31, 2023 December 31, 2022 Assets Cash and cash equivalents $ 129,574 $ 155,385 Total assets $ 144,010 $ 164,810 Total liabilities $ 234,205 $ 239,624 Total stockholders’ deficit $ (90,195 ) $ (74,814 ) Statements of Operations and Comprehensive Loss (Unaudited) (in thousands, except share and per share amounts) Three Months Ended March 31, 2023 2022 Operating expenses: Research and development $ 11,479 $ 17,660 General and administrative 18,598 20,246 Total operating expenses 30,077 37,906 Loss from operations (30,077 ) (37,906 ) Other income (expense): Interest income 1,460 7 Interest expense (9,217 ) (2,759 ) Other expense 20 (7 ) Total other expense (7,737 ) (2,759 ) Net loss and comprehensive loss $ (37,814 ) $ (40,665 ) Net loss per share, basic and diluted $ (0.89 ) $ (1.07 ) Weighted-average shares of common stock outstanding, basic and diluted 42,354,520 38,036,960
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机构
Phathom Pharmaceuticals, Inc.
Takeda Pharmaceutical Co., Ltd.
适应症
胃肠道疾病
胃食管反流
幽门螺杆菌感染
[+3]
靶点
Proton pump
药物
醋酸沃诺拉赞
奈韦拉平
阿莫西林/富马酸伏诺拉生
[+2]
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