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, starting first with inflammatory bowel
disease (IBD), today reported financial results for the quarter
ended September 30, 2021.
“We advanced significant milestones in the third quarter with
the initiations of our two Phase 2 trials in ulcerative colitis and
Crohn’s disease and are on track to readout the topline data of
these two trials in the fourth quarter of 2022,” said Mark McKenna,
Chairman and CEO of Prometheus. “We look forward to announcing our
full Phase 1a trial results and expanding PRA023 into a new
indication beyond IBD this quarter.”
Third Quarter 2021 and Recent Corporate
Highlights
Initiated global Phase 2 ARTEMIS-UC clinical trial of
PRA023 in Ulcerative Colitis (UC). 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 in patients with UC. Topline results for the Phase 2
ARTEMIS-UC trial are expected in 4Q 2022.
Initiated global Phase 2a APOLLO-CD clinical trial of
PRA023 in Crohn’s disease (CD). 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
in patients with CD. Topline results for the Phase 2a APOLLO-CD
trial are expected in 4Q 2022.
Enrolled over 1,500 patients in Prometheus
Enroll360TM 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
characterized 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.
Prometheus Biosciences and Abveris announce multi-target
antibody discovery collaboration. Prometheus and Abveris
entered into a multi-year collaboration to develop therapeutic
antibodies. The collaboration will support the expansion of
Prometheus’ portfolio and complement internal antibody development
capabilities.
Upcoming Milestones and Events
- Final results from the Phase 1a trial of PRA023 expected in 4Q
2021
- New indication announcement for PRA023 in 4Q 2021
- Investigational Device Exemption (IDE) submission of the
companion diagnostic for PRA023 planned for 3Q 2022
- IND submission for PR600 planned for 3Q 2022
- Topline results from the ARTEMIS-UC Phase 2 study expected in
4Q 2022
- Topline results from APOLLO-CD Phase 2a study expected in 4Q
2022
Third Quarter 2021 Financial Results
Cash and Cash Equivalents. As of September 30,
2021, Prometheus Biosciences had cash and cash equivalents of
$279.1 million, compared to $54.2 million at the end of 2020. We
received net proceeds of $73.7 million from the sale of shares of
our Series D-2 convertible preferred stock and net proceeds of
$199.8 million from the sale of our common stock in our IPO, both
in the first quarter.
Collaboration Revenue. Revenue was $1.0 million
for the quarter ended September 30, 2021, compared to $0.4 million
for the quarter ended September 30, 2020. Revenues were $2.1
million for the first nine months of 2021 compared to $0.8 million
for the first nine months of 2020 primarily due to additional
revenue generated from Prometheus’ collaboration with Dr. Falk
Pharma.
Research and Development Expenses. Research and
development expenses were $17.6 million for the quarter ended
September 30, 2021, compared to $4.7 million for the quarter ended
September 30, 2020, and $38.9 million for the first nine months of
2021 compared to $13.8 million for the first nine months of 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 Expenses. General
and administrative expenses were $10.2 million for the quarter
ended September 30, 2021, compared to $3.2 million for the quarter
ended September 30, 2020, and $21.1 million for the first nine
months of 2021 compared to $7.4 million for the first nine months
of 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 an IgG1 humanized monoclonal 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 the two most common forms of IBD,
Ulcerative Colitis (UC) and Crohn’s disease (CD). The Company has
initiated enrollment in a Phase 2 trial in UC patients and a Phase
2a trial in CD patients, each utilizing a genetic-based companion
diagnostic designed to identify 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, starting first with inflammatory bowel disease (IBD). 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 our
current beliefs and expectations. Such forward-looking statements
include, but are not limited to statements regarding: the potential
to rapidly enroll and execute our clinical trials and expand our
approach to other immune-mediated diseases beyond IBD; our
Enroll360 program and ability to accelerate enrollment in our
planned and other future clinical trials; Prometheus’ expected
timing of topline results for its Phase 2 and 2a trials, final
Phase 1a study results and new indication announcement for PRA023,
IDE submission for the PRA023 companion diagnostic, and IND
submission for PR600; and the potential for the collaboration with
Abveris and internal antibody development programs to support the
expansion of our portfolio. 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, 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, including due to the COVID-19 pandemic;
Prometheus’ dependence on third parties in connection with product
manufacturing, research and preclinical and clinical testing, and
potential supply chain disruptions related to the COVID-19
pandemic; Prometheus’ ability to develop a companion diagnostic for
PRA023; the success of clinical trials and preclinical studies for
its product candidates and companion diagnostic; 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; regulatory
developments in the United States and foreign countries; Prometheus
may not realize any benefits from our collaboration with Dr. Falk
or Abveris; and other risks described in our prior press
releases and filings with the Securities and Exchange
Commission (SEC), including under the heading “Risk Factors”
in our 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 we undertake 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 Balance Sheets |
(unaudited) |
(in thousands) |
|
|
|
|
|
|
|
September 30, 2021 |
|
December 31, 2020 |
Assets |
|
|
|
|
Cash, cash equivalents |
$ |
279,116 |
|
|
$ |
54,201 |
|
|
Other current assets |
|
7,992 |
|
|
|
3,255 |
|
|
Total current assets |
|
287,108 |
|
|
|
57,456 |
|
|
Other assets |
|
1,830 |
|
|
|
2,177 |
|
Total assets |
$ |
288,938 |
|
|
$ |
59,633 |
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
Current liabilities |
$ |
15,093 |
|
|
$ |
15,255 |
|
|
Long-term liabilities |
|
11,745 |
|
|
|
15,896 |
|
|
Total liabilities |
|
26,838 |
|
|
|
31,151 |
|
|
Convertible preferred stock |
|
— |
|
|
|
126,023 |
|
|
Total stockholders' equity |
|
262,100 |
|
|
|
(97,541 |
) |
Total liabilities
and stockholders' equity |
$ |
288,938 |
|
|
$ |
59,633 |
|
|
|
|
|
|
|
|
|
Prometheus Biosciences, Inc. |
Condensed Consolidated Statements of
Operations |
(unaudited) |
(in thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
September 30, |
|
September 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue |
$ |
1,006 |
|
|
$ |
359 |
|
|
$ |
2,092 |
|
|
$ |
766 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
|
17,551 |
|
|
|
4,652 |
|
|
|
38,863 |
|
|
|
13,840 |
|
General and
administrative |
|
10,248 |
|
|
|
3,173 |
|
|
|
21,088 |
|
|
|
7,370 |
|
Total operating
expenses |
|
27,799 |
|
|
|
7,825 |
|
|
|
59,951 |
|
|
|
21,210 |
|
Loss from
operations |
|
(26,793) |
|
|
|
(7,466) |
|
|
|
(57,859) |
|
|
|
(20,444) |
|
Other income
(expense), net |
|
(540) |
|
|
|
(360) |
|
|
|
(2,418) |
|
|
|
(1,487) |
|
Loss from
continued operations |
|
(27,333) |
|
|
|
(7,826) |
|
|
|
(60,277) |
|
|
|
(21,931) |
|
Loss from
discontinued operations |
|
— |
|
|
|
879 |
|
|
|
— |
|
|
|
(6,584) |
|
Net loss |
$ |
(27,333) |
|
|
$ |
(6,947) |
|
|
$ |
(60,277) |
|
|
$ |
(28,515) |
|
Net loss per
share, basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continued operations |
|
$ |
(0.70) |
|
|
$ |
(5.13) |
|
|
$ |
(2.09) |
|
|
$ |
(15.21) |
|
Discontinued operations |
|
$ |
— |
|
|
$ |
0.58 |
|
|
$ |
— |
|
|
$ |
(4.57) |
|
Net loss per
share, basic and diluted |
$ |
(0.70) |
|
|
$ |
(4.55) |
|
|
$ |
(2.09) |
|
|
$ |
(19.78) |
|
Weighted average
common shares outstanding - basic and diluted |
|
38,848,412 |
|
|
|
1,526,122 |
|
|
|
28,778,814 |
|
|
|
1,441,516 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Company Contact:Noel KurdiVP Investor Relations
and Communications(646)
241-4400nkurdi@prometheusbiosciences.com
Media Contact:Jake RobisonCanaleComm, an
Ashfield Health Company(619)
849-5383jake.robison@canalecomm.com
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