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 and full-year ended December 31, 2021 and highlighted
recent corporate progress.
“2021 was a transformational year for
Prometheus, and we begin 2022 in our strongest position to date,”
said Mark McKenna, Chairman and CEO. “Prometheus is the first
company to implement precision medicine in immunology and we
continue to execute on this pioneering approach. We believe PRA023
is potentially a best-in-class anti-TL1A inhibitor, with a broad
development program for multiple immune-mediated diseases in large
markets that are primed for disruption. We are currently advancing
three clinical trials of PRA023 for ulcerative colitis, Crohn’s
disease and SSc-ILD, and currently anticipate top line data
readouts in both UC and CD in the fourth quarter.”
FOURTH QUARTER AND FULL-YEAR 2021 AND
RECENT CORPORATE HIGHLIGHTS
PIPELINE AND PLATFORM HIGHLIGHTS
Reported positive topline results from Phase 1 trial of
PRA023 in healthy volunteers. In December, Prometheus
reported positive topline results from the Phase 1 trial to assess
the safety, tolerability, pharmacokinetics, and pharmacodynamics of
PRA023 in normal healthy volunteers and observed that PRA023 was
well-tolerated, with no safety signal identified during the study.
Prometheus also described a number of potentially differentiating
features of the PRA023 program, including robust target engagement,
a favorable immunogenicity profile, a Phase 2 dosing profile that
is designed to quickly achieve steady state concentrations of drug,
and a subcutaneous formulation of 200 mg/ml with a development plan
designed to support the use of autoinjectors in future
registrational studies.
Initiated 2 global Phase 2 clinical studies for PRA023
in Ulcerative Colitis (UC) and Crohn’s
disease:
- Prometheus’ Phase 2 ARTEMIS-UC
clinical trial is currently enrolling patients with
moderate-to-severely active UC who have failed conventional
therapy, including biologics. The trial is a 12-week, double-blind,
placebo-controlled, randomized study to evaluate the efficacy and
safety of PRA023 in patients with UC. The initial cohort is
statistically powered to evaluate the efficacy of PRA023 in
patients with UC. The expansion cohort is statistically powered to
further evaluate the effectiveness of the company’s companion
diagnostic candidate in patients with UC. Topline results are
expected in 4Q 2022.
- Prometheus’ Phase 2a APOLLO-CD
clinical trial is a 12-week open-label study that is currently
enrolling patients with moderate-to-severely active CD with
endoscopically active disease who have failed conventional therapy,
including biologics. The study will assess the efficacy of PRA023
and the effectiveness of the company’s companion diagnostic
candidate in patients with CD. Topline results expected in 4Q
2022.
Expanded development of PRA023 into third
indication, SSc-ILD.
Prometheus broadened its pipeline by adding a third indication for
PRA023, Systemic Sclerosis-associated Interstitial Lung Disease
(SSc-ILD). Systemic Sclerosis (SSc) is an autoimmune disorder
characterized by progressive fibrosis of the skin and internal
organs thought to result from inflammation and chronic immune
activation. Lung parenchymal involvement (SSc-ILD) is the leading
cause of morbidity and mortality for individuals with the disorder.
The company plans to initiate the ATHENA-SSc-ILD study in the first
quarter of 2022, which will also assess the performance of the
company’s companion diagnostic candidate.
Received Fast Track Designation for PRA023 for
SSc-ILD. The US FDA has granted Fast Track Designation for
Prometheus’ lead therapeutic candidate, PRA023, for the treatment
of SSc-ILD.
Enrolled over 2,000 patients in Prometheus
Enroll360™ platform. Prometheus’
Enroll360™ is a global patient recruitment platform that is
designed to accelerate development timelines by improving the
efficiency of patient identification and increasing the rate of
enrollment for the company’s biomarker-guided clinical trials.
Prometheus is building a global network of trial-ready sites where
over 5,000 patients will be molecularly profiled and clinically
evaluated to determine their eligibility for Prometheus clinical
trials. The company plans to utilize Enroll360™ in Prometheus’
companion diagnostic-paired clinical trials for PRA023 as well as
future programs.
New patent granted for PRA023 companion diagnostic
(CDx). The U.S. Patent and Trademark Office (USPTO) has
granted a U.S. patent to Prometheus covering its companion
diagnostic technology, which covers claims directed to methods of
treating CD or UC by administering inhibitors of tumor necrosis
factor-like cytokine 1A (TL1A) to patients selected by a defined
companion diagnostic test. This newly granted patent reinforces
Prometheus’ precision approach and extends the company’s patent
coverage of its PRA023 companion diagnostic candidate into
2040.
CORPORATE HIGHLIGHTS
Completed oversubscribed $218.5M
Initial Public Offering (IPO); ended 2021 as one of the best
performing IPOs of 2021 across all industries. Prometheus
completed its IPO in March 2021 and was the top-performing biotech
IPO in 2021, despite the challenging environment for biotech
stocks.
Received $20M in milestone payments from Dr. Falk Pharma
for PR600. Prometheus achieved multiple significant
milestones in 2021 from its collaboration with Dr. Falk Pharma GmbH
with the selection of a clinical candidate in the PR 600 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 and plans to explore its utility in other
immune-mediated indications beyond IBD.
Signed agreement with Ypsomed for development and
clinical supply of autoinjector. Prometheus is
collaborating with Swiss-based developer and manufacturer of
injection and infusion systems to develop an autoinjector for
potential use in PRA023 registrational studies in UC and CD based
on their commercially approved platform.
UPCOMING 2022 MILESTONES AND EVENTS
- Initiation of SSc-ILD Phase 2 study
expected by end of 1Q
- Update on UC and CD Phase 2
enrollment planned in 2Q
- Investigational Device Exemption
(IDE) submission of the companion diagnostic for PRA023 planned in
3Q
- 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
FOURTH QUARTER AND FULL-YEAR 2021 FINANCIAL
RESULTS
Cash and Cash Equivalents. As of
December 31, 2021, Prometheus Biosciences had cash and cash
equivalents of $257.3 million, compared to $54.2 million at the end
of 2020.
Collaboration Revenue. Revenue was $1.0
million for the three months ended December 31, 2021 compared to
$0.5 million for the three months ended December 31, 2020 and $3.1
million for the full year 2021 compared with $1.2 million for the
full year 2020. The increase is primarily due to additional
revenue generated from Prometheus’ partnership with Dr. Falk Pharma
GmbH.
Research and Development (R&D) Expenses.
Research and development expenses were $23.6 million for the three
months ended December 31, 2021 compared to $5.3 million for the
three months ended December 31, 2020 and $62.4 million for the full
year 2021 compared with $19.1 million for the full year
2020. The increases were primarily driven by advancement
of PRA023 into global Phase 2 clinical trials, as well as advancing
our other development programs.
General and Administrative (G&A) Expenses.
General and administrative expenses were $7.4 million for the three
months ended December 31, 2021 compared to $3.7 million for the
three months ended December 31, 2020 and $28.5 million for the full
year 2021 compared with $11.1 million for the full year
2020. The increases were primarily due to an
increase in expenses related to operating as a public company and
an increase in personnel and stock-based compensation.
About PRA023
PRA023 is a humanized IgG1monoclonal antibody (mAb) that has
been shown to bind and neutralize both the active trimeric form and
inactive monomeric form of 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 the newly
identified systemic sclerosis-associated interstitial lung disease
(SSc-ILD). The company is currently conducting a Phase 2 trial in
UC patients and a Phase 2a trial in CD patients, 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. The company
also plans to initiate a Phase 2 clinical trial for PRA023 in
SSc-ILD by the end of the first quarter.
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 commencement of Prometheus’ Phase 2 clinical trial in
SSc-ILD; Prometheus’ timing to provide an update regarding
enrollment in its ongoing Phase 2 clinical trial in UC and its
ongoing Phase 2a clinical trial in CD as well as the timing to
announce topline data from these studies; Prometheus’ Enroll360
program and its ability to accelerate enrollment in Prometheus’
ongoing PRA023 clinical trials as well as other future clinical
trials; Prometheus’ timing and ability to develop an autoinjector
for use in potential future registrational studies of PRA023; the
timing to submit an IND for Prometheus’ PR600 therapeutic
candidate; timing to submit an IDE for the its companion diagnostic
candidate for PRA023; and the potential for PRA023, if approved, to
be a differentiated anti-TL1A inhibitor. The inclusion of
forward-looking statements should not be regarded as a
representation by Prometheus 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 our
business, including, without limitation: Prometheus’ approach to
the discovery and development of precision medicines based on
Prometheus360 is unproven, and the company may not be able to
develop any therapeutics or companion diagnostic products of
commercial value; 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 its
therapeutic product candidates; the success of clinical trials and
preclinical studies for the company’s therapeutic product
candidates and its companion diagnostic 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 its current and any
future collaborations; regulatory developments in the United
States and foreign countries; Prometheus’ ability to obtain
and maintain intellectual property protection for its product
candidates and maintain its rights under intellectual property
licenses; Prometheus’ ability to maintain undisrupted business
operations due to the COVID-19 pandemic, 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 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 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 |
(in thousands, except share and per share
data)(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Twelve
Months Ended |
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
1,037 |
|
|
$ |
463 |
|
|
$ |
3,129 |
|
|
$ |
1,229 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
23,564 |
|
|
|
5,307 |
|
|
|
62,427 |
|
|
|
19,147 |
|
General and
administrative |
|
|
7,417 |
|
|
|
3,719 |
|
|
|
28,505 |
|
|
|
11,089 |
|
Total operating expenses |
|
|
30,981 |
|
|
|
9,026 |
|
|
|
90,932 |
|
|
|
30,236 |
|
Loss from operations |
|
|
(29,944) |
|
|
|
(8,563) |
|
|
|
(87,803) |
|
|
|
(29,007) |
|
Other income (expense),
net |
|
|
26 |
|
|
|
(645) |
|
|
|
(2,392) |
|
|
|
(2,132) |
|
Loss from continuing
operations |
|
|
(29,918) |
|
|
|
(9,208) |
|
|
|
(90,195) |
|
|
|
(31,139) |
|
Loss from discontinued
operations |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5,999) |
|
Net loss |
|
$ |
(29,918) |
|
|
$ |
(9,208) |
|
|
$ |
(90,195) |
|
|
$ |
(37,138) |
|
Net loss per share, basic and
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations |
|
$ |
(0.77) |
|
|
$ |
(5.51) |
|
|
$ |
(2.88) |
|
|
$ |
(20.78) |
|
Discontinued operations |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(4.00) |
|
Net loss per share, basic and
diluted |
|
$ |
(0.77) |
|
|
$ |
(5.51) |
|
|
$ |
(2.88) |
|
|
$ |
(24.78) |
|
Weighted average shares
outstanding - basic and diluted |
|
|
38,916,838 |
|
|
|
1,670,095 |
|
|
|
31,334,154 |
|
|
|
1,498,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prometheus Biosciences, Inc. |
Condensed Consolidated Balance Sheets |
(in thousands)(unaudited) |
|
|
|
|
|
December 31, 2021 |
|
December 31, 2020 |
Assets |
|
|
|
Cash and cash equivalents |
$ |
257,254 |
|
|
$ |
54,201 |
|
Other current assets |
|
8,129 |
|
|
|
3,255 |
|
Total current assets |
|
265,383 |
|
|
|
57,456 |
|
Other assets |
|
2,418 |
|
|
|
2,177 |
|
Total assets |
$ |
267,801 |
|
|
$ |
59,633 |
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
Current liabilities |
$ |
16,442 |
|
|
$ |
15,255 |
|
Long-term liabilities |
|
16,204 |
|
|
|
15,896 |
|
Total liabilities |
|
32,646 |
|
|
|
31,151 |
|
Convertible preferred stock |
|
— |
|
|
|
126,023 |
|
Total stockholders' equity (deficit) |
|
235,155 |
|
|
|
(97,541 |
) |
Total liabilities and
stockholders' equity |
$ |
267,801 |
|
|
$ |
59,633 |
|
|
|
|
|
|
|
|
|
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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