Prometheus Biosciences, Inc. (Nasdaq: RXDX), a clinical-stage
biotechnology company pioneering a precision medicine approach for
the discovery, development, and commercialization of novel
therapeutic and companion diagnostic products for the treatment of
immune-mediated diseases, today reported financial results for the
quarter ended March 31, 2022 and highlighted recent corporate
progress.
“I couldn’t be more pleased with the execution our
team has demonstrated during a very challenging external backdrop.
Despite significant global headwinds and our aggressive timelines,
we are still on track to deliver on our near-term milestones,
namely the topline results from our Artemis-UC Phase 2 and
Apollo-CD Phase 2a trials in the fourth quarter this year,” said
Mark McKenna, Chairman and CEO.
FIRST QUARTER 2022 AND RECENT CORPORATE
HIGHLIGHTS
PIPELINE AND PLATFORM HIGHLIGHTS
Initiated third Phase 2 study of PRA023 for Systemic
Sclerosis-Associated Interstitial Lung Disease (SSc-ILD).
Prometheus initiated the ATHENA-SSc-ILD trial, a placebo-controlled
Phase 2 trial of PRA023 in SSc-ILD. Systemic Sclerosis (SSc) is a
rare autoimmune disorder characterized by progressive fibrosis of
the skin and internal organs thought to result from inflammation
and chronic immune activation. Lung involvement is the leading
cause of morbidity and mortality for individuals with the
disorder.
Received Fast Track Designation for PRA023 for
SSc-ILD. The US FDA granted Fast Track Designation for
Prometheus’ lead therapeutic candidate, PRA023, for the treatment
of SSc-ILD.
Initiated PRA023 subcutaneous bridging study in normal
healthy volunteers. Prometheus initiated dosing of
Caucasian normal healthy volunteers with PRA023 to assess the
bioavailability of the subcutaneous formulation. In addition,
Prometheus also initiated dosing of healthy volunteers of Japanese
descent with PRA023 as part of the bridging study to assess safety,
tolerability, and pharmacokinetics.
New patent granted for PRA023 companion
diagnostic. The US Patent and Trademark Office
(USPTO) granted a US patent to Prometheus covering claims directed
to methods of treating Crohn’s disease or ulcerative colitis by
administering inhibitors of tumor necrosis factor-like cytokine 1A
(TL1A) to patients selected by a defined companion diagnostic test.
This granted patent reinforces Prometheus’ precision approach and
extends the Company’s patent coverage of its PRA023 companion
diagnostic candidate into 2040.
RECENT CORPORATE HIGHLIGHTS
Appointed Marla Hochfeld, MD, as Senior Vice President
of Clinical Development and Clinical Affairs. In May 2022,
Prometheus hired Dr. Hochfeld as Senior Vice President of Clinical
Development and Clinical Affairs. Dr. Hochfeld will be responsible
for leading and expanding the Company’s pipeline of immune-mediated
programs. Most recently, she served as Vice President, Head of
Clinical Development for Immunology and Fibrosis at Bristol Myers
Squibb, where she established and evolved the global Immunology and
Fibrosis clinical development organization, including setting the
clinical strategy and achieving global approvals of Zeposia for
multiple sclerosis and ulcerative colitis. Dr. Hochfeld received
her MD from Hahnemann University and a BS from the University of
Pennsylvania. She completed a residency in internal medicine and
fellowship in rheumatology at Stanford University.
Appointed Deepti Garg, PhD, as Vice President of
Companion Diagnostics. In March 2022, Prometheus hired Dr.
Garg as Vice President of Companion Diagnostics. Dr. Garg is
responsible for the development, regulatory and commercialization
strategy of Prometheus’ companion diagnostic portfolio. Prior to
joining, Dr. Garg served as Executive Director, Biomarkers and
Companion Diagnostics at Merck, where she led several
first-in-class companion diagnostic approvals for their blockbuster
KEYTRUDA. Dr. Garg received her PhD in Molecular Biology and
Immunology from Indiana University and completed her postdoctoral
training at Children’s Hospital, Boston, an affiliate of Harvard
Medical School.
Received final milestone payment from Dr. Falk Pharma
for PR600. Prometheus has achieved multiple
significant milestones from its collaboration with Dr. Falk Pharma
GmbH with the selection of a clinical candidate in the PR600
program, which targets an undisclosed member of the tumor-necrosis
factor superfamily for the treatment of IBD. The Company expects to
file an Investigational New Drug (IND) application for PR600 in the
third quarter of 2022.
UPCOMING MILESTONES AND EVENTS
- Update on UC and CD Phase 2 enrollment planned in 2Q
- IND submission for PR600 planned for 3Q
- Topline results from the ARTEMIS-UC Phase 2 study expected in
4Q
- Topline results from APOLLO-CD Phase 2a study expected in
4Q
FIRST QUARTER 2022 FINANCIAL RESULTS
Cash and Cash Equivalents. As of March 31,
2022, Prometheus Biosciences had cash and cash equivalents of
$227.0 million, compared to $257.3 million at the end of Q4
2021.
Collaboration Revenue. Revenue was
$3.9 million for the three months ended March 31, 2022
compared to $0.8 million for the three months ended March 31,
2021 primarily due to additional revenue generated from Prometheus’
partnership with Dr. Falk Pharma.
Research and Development (R&D) Expenses.
Research and development expenses were $27.9 million for the
three months ended March 31, 2022 compared to $7.8 million for
the three months ended March 31, 2021 primarily due to advancement
of PRA023 through global Phase 2 clinical trials and PR600 toward
IND.
General and Administrative (G&A) Expenses.
General and administrative expenses were $8.1 million for the
three months ended March 31, 2022 compared to $5.2 million for
the three months ended March 31, 2021 primarily due to an increase
in stock-based compensation and expenses associated with being a
public company.
About PRA023: Pipeline in a Product
PRA023 is a humanized IgG1monoclonal antibody (mAb) that has
been shown to block tumor necrosis factor (TNF)-like ligand 1A
(TL1A). PRA023 binds both soluble and membrane-associated human
TL1A with high affinity and specificity and has the potential to
substantially improve outcomes for moderate-to-severe IBD patients
predisposed to increased TL1A expression. Prometheus is developing
PRA023 for the treatment of immune-mediated diseases including
Ulcerative colitis (UC), Crohn’s disease (CD), and systemic
sclerosis-associated interstitial lung disease (SSc-ILD).
The Company is currently conducting three Phase 2 studies of
PRA023: a Phase 2 trial in UC patients, ARTEMIS-UC, a Phase 2a
trial in CD patients, APOLLO-CD, and a Phase 2 clinical trial in
SSc-ILD, ATHENA-SSc-ILD, each utilizing a genetic-based companion
diagnostic candidate designed to classify patients who are
predisposed to increased expression of TL1A and therefore
potentially more likely to respond to PRA023.
About Prometheus Biosciences
Prometheus Biosciences, Inc. is a clinical-stage biotechnology
company pioneering a precision medicine approach for the discovery,
development, and commercialization of novel therapeutic and
companion diagnostic products for the treatment of immune-mediated
diseases. The company’s precision medicine platform,
Prometheus360™, combines proprietary machine learning-based
analytical approaches with one of the world’s largest
gastrointestinal bioinformatics databases to identify novel
therapeutic targets and develop therapeutic candidates to engage
those targets.
Forward Looking Statements
Prometheus cautions readers 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 timing of Prometheus’ APOLLO-CD, ARTEMIS-UC and ATHENA-SSc-ILD
clinical trials; the ability of Prometheus’ genetic-based companion
diagnostic candidate to classify patients who are predisposed to
increased expression of TL1A or more likely to respond to PRA023;
and the timing of Prometheus’ planned IND and IDE submissions. The
inclusion of forward-looking statements should not be regarded as a
representation by Prometheus that any of our plans will be
achieved. Actual results may differ from those set forth in this
press release due to the risks and uncertainties inherent in our
business, including, without limitation: Prometheus’ approach to
the discovery and development of precision medicines based on
Prometheus360 is unproven; potential delays in the commencement,
enrollment and completion of clinical trials and preclinical
studies; Prometheus’ dependence on third parties in connection with
product manufacturing, research and preclinical and clinical
testing; Prometheus’ ability to develop companion diagnostics for
our therapeutic product candidates; unexpected adverse side effects
or inadequate efficacy of our product candidates that may limit
their development, regulatory approval and/or commercialization, or
may result in recalls or product liability claims; the results of
preclinical studies and early clinical trials are not necessarily
predictive of future results; Prometheus may not realize any
benefits from our current and any future collaborations; regulatory
developments in the United States and foreign countries;
Prometheus’ ability to obtain and maintain intellectual property
protection for our product candidates and maintain our rights under
intellectual property licenses; Prometheus’ ability to maintain
undisrupted business operations due to the COVID-19 pandemic or the
ongoing conflict between Russia and Ukraine, including delaying or
otherwise disrupting its clinical trials, manufacturing and supply
chain; and other risks described in the company’s prior press
releases and filings with the Securities and Exchange
Commission (SEC), including under the heading “Risk Factors”
in Prometheus’ most recent quarterly report on Form 10-Q 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 Prometheus 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.
Prometheus Biosciences,
Inc.Condensed Consolidated Statements of
Operations(unaudited)(in thousands, except share and per
share data)
|
Three Months Ended |
|
|
March 31, |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
Collaboration revenue |
$ |
3,919 |
|
|
$ |
760 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
27,930 |
|
|
|
7,758 |
|
General and
administrative |
|
8,085 |
|
|
|
5,222 |
|
Total operating expenses |
|
36,015 |
|
|
|
12,980 |
|
Loss from operations |
|
(32,096 |
) |
|
|
(12,220 |
) |
Other income (expense),
net |
|
30 |
|
|
|
(1,725 |
) |
Net loss |
$ |
(32,066 |
) |
|
$ |
(13,945 |
) |
Net loss per share, basic and
diluted |
$ |
(0.82 |
) |
|
$ |
(1.67 |
) |
Weighted average shares
outstanding - basic and diluted |
|
39,006,794 |
|
|
|
8,338,892 |
|
Prometheus Biosciences,
Inc.Condensed Consolidated Balance
Sheets (unaudited)(in thousands)
|
|
March 31, 2022 |
|
|
December 31, 2021 |
Assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
227,034 |
|
|
$ |
257,254 |
Other current assets |
|
|
7,950 |
|
|
|
8,129 |
Total current assets |
|
|
234,984 |
|
|
|
265,383 |
Other assets |
|
|
18,597 |
|
|
|
2,418 |
Total assets |
|
$ |
253,581 |
|
|
$ |
267,801 |
|
|
|
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
Current liabilities |
|
$ |
17,324 |
|
|
$ |
16,442 |
Long-term liabilities |
|
|
29,534 |
|
|
|
16,204 |
Total liabilities |
|
|
46,858 |
|
|
|
32,646 |
Total stockholders’ equity |
|
|
206,723 |
|
|
|
235,155 |
Total liabilities and
stockholders’ equity |
|
$ |
253,581 |
|
|
$ |
267,801 |
Contacts:Noel KurdiVP Investor Relations and
Communications(646) 241-4400nkurdi@prometheusbiosciences.com
Media contact:Juniper PointAmy Conrad(858)
914-1962media@prometheusbiosciences.com
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