Prometheus Biosciences, Inc. (Nasdaq: RXDX), a 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 March 31,
2021 and highlighted recent corporate progress.
“2021 is shaping up to be a transformational
year for Prometheus with the successful completion of our IPO and
planned advancement of our lead program, PRA023, into a Phase 2
Ulcerative Colitis (UC) trial and a Phase 2a Crohn’s Disease (CD)
trial in the third quarter,” said Mark McKenna, President and CEO
of Prometheus. “This will be the first trial in the IBD space that
will utilize a precision medicine approach with a novel mechanism
of action designed to address both inflammation and fibrosis, which
we believe is important to drive clinically meaningful outcomes for
patients.”
First Quarter 2021 and Recent Corporate
Highlights
Launched Prometheus Enroll360™ to accelerate patient
recruitment. 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 its 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.
Expanded precision medicine pipeline with new programs
for IBD
- PR1100 targets a pro-inflammatory cytokine
receptor associated with several auto-immune diseases, with
multiple Crohn’s disease-associated SNPs identified in the gene
locus of this target, and other members of this signaling
pathway
- PR1800 targets a
chemo-attractant factor which contributes to the local accumulation
of a defined inflammatory effector cell population in the GI
tract
- PR2100 targets a
cytokine implicated in a range of inflammatory and fibrotic
diseases. In IBD specifically, this cytokine has been implicated to
contribute to non-response to anti-TNF therapies
Strengthened leadership and Board of Directors.
Prometheus appointed commercial veteran Mark Stenhouse as Chief
Operating Officer, Chris Doughty as Chief Business Officer, and
Nori Ebersole as Chief People Officer to the Company and appointed
experienced biotech leaders Helen C. Adams, CPA, Judith Swain, MD,
and Mary Szela to its Board of Directors.
Completed initial public offering.
On March 16, 2021, the company completed its IPO issuing 11,500,000
shares of common stock, which included the full exercise by the
underwriters of their option to purchase 1,500,000 additional
shares, at $19.00 per share resulting in gross proceeds of $218.5
million, before deducting underwriting discounts and commissions
and other offering expenses.
Upcoming Milestones and Events
- Initiation of Phase 2 UC trial and Phase 2a CD trial of PRA023
expected in 3Q 2021
- R&D day planned for 3Q 2021 to discuss TL1A mechanism and
PRA023 Phase 2 study designs
- Final Phase 1a trial results of PRA023 expected in 4Q 2021
First Quarter 2021 Financial Results
Cash and Cash Equivalents. As of
March 31, 2021, Prometheus Biosciences had cash and cash
equivalents of $311.2 million, compared to $54.2 million at the end
of 2020. We received net proceeds of $199.8 million from the
sale of our common stock in our IPO, and net proceeds of $73.7
million from the sale of shares of our Series D-2 convertible
preferred stock.
Collaboration Revenue. Revenue was
$0.8 million for the three months ended March 31, 2021
compared to $0.2 million for the three months ended March 31,
2020 due to additional revenue generated from Prometheus’
partnership with Dr. Falk Pharma.
Research and Development (R&D) Expenses.
Research and development expenses were $7.8 million for the
three months ended March 31, 2021 compared to $4.3 million for
the three months ended March 31, 2020. The increase of
$3.5 million for the three months ended March 31, 2021
compared to the three months ended March 31, 2020 was primarily
driven by a $3.0 million increase in expenses related to
research and development expenses for our product candidates and a
$0.5 million increase in expenses related to personnel costs
due to increased headcount to support increased development
activities.
General and Administrative (G&A) Expenses.
General and administrative expenses were $5.2 million for the
three months ended March 31, 2021 compared to $2.4 million for
the three months ended March 31, 2020. The increase of
$2.8 million for the three months ended March 31, 2021
compared to the three months ended March 31, 2020 was primarily
driven by one-time transaction costs related to our IPO of $1.8
million with the remainder due to increases in corporate personnel
costs due to the expansion of our executive team.
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 Ulcerative Colitis (UC) and
Crohn’s Disease (CD) and initiated a Phase 1a clinical trial
in normal healthy volunteers in December 2020. The Company is also
developing a genetic-based companion diagnostic 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 biotechnology company
pioneering a precision medicine approach for the discovery,
development, and commercialization of novel therapeutic and
companion diagnostic products for the treatment and diagnosis of
immune-mediated diseases, starting first with IBD. The
Company’s precision medicine platform, Prometheus360, combines
proprietary bioinformatics discovery methods with one of the
world’s largest gastrointestinal bioinformatics databases to
identify novel therapeutic targets and develop therapeutic
candidates to engage those targets. Prometheus is
headquartered in San Diego, CA.
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
UC and its Phase 2a clinical trial in CD; Prometheus’ Enroll360
program and the company’s ability to accelerate enrollment in its
planned and other future clinical trials; and the timing of
Prometheus obtaining the final study results from its Phase 1a
clinical trial of PRA023. 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, 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 |
31-Mar |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
Collaboration
revenue |
$ |
760 |
|
|
$ |
228 |
|
Operating
expenses: |
|
|
|
Research and
development |
|
7,758 |
|
|
|
4,265 |
|
General and
administrative |
|
5,222 |
|
|
|
2,387 |
|
Total operating
expenses |
|
12,980 |
|
|
|
6,652 |
|
Loss from
operations |
|
(12,220 |
) |
|
|
(6,424 |
) |
Other income
(expense), net |
|
(1,725 |
) |
|
|
(530 |
) |
Loss from
continued operations |
|
(13,945 |
) |
|
|
(6,954 |
) |
Loss from
discontinued operations |
|
— |
|
|
|
(6,174 |
) |
Net loss |
$ |
(13,945 |
) |
|
$ |
(13,128 |
) |
Net loss per
share, basic and diluted |
|
|
|
|
|
Continued operations |
|
$ |
(1.67 |
) |
|
$ |
(5.06 |
) |
Discontinued operations |
|
$ |
— |
|
|
$ |
(4.50 |
) |
Net loss per
share, basic and diluted |
$ |
(1.67 |
) |
|
$ |
(9.56 |
) |
Weighted average
common shares outstanding - basic and diluted |
|
8,338,892 |
|
|
|
1,373,050 |
|
|
|
|
|
|
|
|
Prometheus Biosciences, Inc. |
Condensed Consolidated Balance Sheets |
(unaudited) |
(in thousands) |
|
|
|
|
|
March 31,2021 |
|
December 31,2020 |
Assets |
|
|
|
Cash, cash equivalents |
$ |
311,231 |
|
|
$ |
54,201 |
|
Other current assets |
|
7,389 |
|
|
|
3,255 |
|
Total current assets |
|
318,620 |
|
|
|
57,456 |
|
Other assets |
|
1,381 |
|
|
|
2,177 |
|
Total assets |
$ |
320,001 |
|
|
$ |
59,633 |
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Current liabilities |
$ |
8,787 |
|
|
$ |
15,255 |
|
Long-term liabilities |
|
11,015 |
|
|
|
15,896 |
|
Total liabilities |
|
19,802 |
|
|
|
31,151 |
|
Convertible preferred stock |
|
— |
|
|
|
126,023 |
|
Total stockholders' equity |
|
300,199 |
|
|
|
(97,541 |
) |
Total liabilities
and stockholders' equity |
$ |
320,001 |
|
|
$ |
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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