DICE Therapeutics Reports First Quarter 2023 Financial Results and Recent Highlights
11 Mayo 2023 - 3:05PM
DICE Therapeutics, Inc. (Nasdaq: DICE) (DICE or the Company), a
biopharmaceutical company leveraging its proprietary DELSCAPE
technology platform to build a pipeline of novel oral therapeutic
candidates to treat chronic diseases in immunology, today reported
financial results for the first quarter ended March 31, 2023, and
highlighted recent corporate achievements.
“Our oral IL-17 franchise continues to advance
on multiple fronts. The first psoriasis patient has been dosed in
our global, dose-ranging Phase 2b clinical trial of DC-806,” said
Kevin Judice, Ph.D., CEO of DICE. “We also look forward to topline
data in healthy volunteers from our Phase 1 trial with our second
oral IL-17 inhibitor, DC-853, expected in the second half of 2023.
Additionally, we are excited about the progress of our earlier
stage research and development (R&D) programs and continuing to
utilize our DELSCAPE platform to accelerate the expansion of our
pipeline to other validated targets in immunology.”
Recent Highlights & Upcoming Events
-
Results from DICE’s Phase 1 proof-of-concept clinical trial of
DC-806, including additional biomarker data, were presented in a
late-breaking oral session at the 2023 American Academy of
Dermatology (AAD) Annual Meeting in March 2023.
- The first patient has been dosed in
a global, dose-ranging Phase 2b clinical trial of DICE’s lead oral
IL-17 inhibitor, DC-806.
- The randomized, double-blind, placebo-controlled trial aims to
enroll approximately 225 patients with moderate-to-severe psoriasis
and will evaluate multiple doses of DC-806 compared to placebo over
a 12-week treatment period to further explore peak efficacy and
inform induction and maintenance doses for Phase 3 development. The
primary endpoint is percentage of patients with ≥ 75% in Psoriasis
Area and Severity Index score reduction from baseline
(PASI-75).
-
Continued enrollment of participants in DICE’s Phase 1 clinical
trial of DC-853, a second oral IL-17 antagonist, in healthy
volunteers. Topline data are expected in the second half of
2023.
-
DICE plans to host an R&D Event on Tuesday, June 20, 2023. The
event will highlight progress on the Company’s clinical-stage and
discovery programs as well as key aspects of the DELSCAPE
platform.
First Quarter 2023 Financial Highlights
- Cash
Position: Cash, cash equivalents and marketable securities
totaled $554.5 million at March 31, 2023. The Company expects its
current cash position to fund operations through expected key
clinical milestones and into 2026.
- R&D Expenses:
Research and development expenses were $23.7 million for the first
quarter of 2023, compared to $13.4 million for the same period in
2022. The increase was primarily due to the advancement of
DICE’s IL-17 franchise and other research programs, and
increases related to personnel expenses due to an increase in
headcount and stock-based compensation expense.
- G&A Expenses:
General and administrative expenses were $7.9 million for the first
quarter of 2023, compared to $5.4 million for the same period in
2022. The increase was primarily due to an increase in personnel
costs related to increased headcount and stock-based compensation
and an increase in professional service fees and other costs
associated with operating as a publicly-traded company.
- Net Loss: Net loss
totaled $25.6 million and $18.6 million for the first quarters of
2023 and 2022, respectively, with non-cash stock-based compensation
expense of $4.9 million and $1.8 million for the first quarters of
2023 and 2022, respectively.
About the DICE Oral IL-17
FranchiseDICE is developing orally-available, small
molecule antagonists of the pro-inflammatory signaling molecule
IL-17, an immune cell-derived cytokine. Blockade of this pathway
has proven to be an effective therapy in a number of auto-immune
diseases. The anti-IL-17 injectable biologics have been approved
for the treatment of psoriasis, psoriatic arthritis, ankylosing
spondylitis and non-radiographic axial spondyloarthritis.
The DICE oral IL-17 franchise includes the lead
therapeutic candidate, DC-806, the differentiated fast-follower
candidate, DC-853, and the novel scaffold program. DICE is
developing its lead therapeutic candidate, DC-806, for the
treatment of psoriasis and plans to expand development to
additional indications in which the marketed anti-IL-17 injectable
biologics have proven to be effective. The Company is considering
multiple applications for its differentiated fast-follower, DC-853,
including potential development in distinct indications from
DC-806, such as hidradenitis suppurativa.
About DICE Therapeutics,
Inc.DICE Therapeutics, Inc. is a biopharmaceutical company
leveraging its proprietary technology platform to build a pipeline
of novel oral therapeutic candidates to treat chronic diseases in
immunology and other therapeutic areas. DICE is initially focused
on developing oral therapeutics against well-validated targets in
immunology, with the goal of achieving comparable potency to their
systemic biologic counterparts, which have demonstrated the
greatest therapeutic benefit to date in these disease areas. The
Company’s DELSCAPE platform is designed to discover selective oral
small molecules with the potential to modulate protein-protein
interactions (PPIs) as effectively as systemic biologics. DICE’s
lead therapeutic candidates are oral antagonists of the
pro-inflammatory signaling molecule, IL-17, which is a validated
drug target implicated in a variety of immunology indications. DICE
is also developing oral therapeutic candidates targeting the
integrin α4ß7 for the treatment of inflammatory bowel disease.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of the “safe
harbor” provisions of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements reflect the current
beliefs and expectations of management. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements, including, without limitation,
statements concerning the Company’s future plans and prospects, the
Company’s anticipated runway, any expectations regarding the safety
or efficacy of DC-806 and other candidates under development, the
ability of DC-806 to treat psoriasis or related indications, the
planned timing of the Company’s clinical trials, data results and
further development of DC-806 and DC-853. In addition, when or if
used in this press release, the words “may,” “could,” “should,”
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,”
“predict” and similar expressions and their variants, as they
relate to the Company may identify forward-looking statements.
Forward-looking statements are neither historical facts nor
assurances of future performance. Although the Company believes the
expectations reflected in such forward-looking statements are
reasonable, the Company can give no assurance that such
expectations will prove to be correct. Readers are cautioned that
actual results, levels of activity, safety, performance or events
and circumstances could differ materially from those expressed or
implied in the Company’s forward-looking statements due to a
variety of factors, including risks and uncertainties related to
the Company’s ability to advance DC-806, DC-853 and its other
therapeutic candidates, obtain regulatory approval of and
ultimately commercialize the Company’s therapeutic candidates, the
timing and results of preclinical and clinical trials, the
Company’s ability to fund development activities and achieve
development goals, the impact of the COVID-19 pandemic on the
Company’s business, its ability to protect its intellectual
property and other risks and uncertainties described under the
heading “Risk Factors” in the Company’s annual report on Form 10-Q
filed on May 11, 2023, and its other SEC filings.
Accordingly, readers are cautioned not to place undue reliance on
these forward-looking statements. Except as required by applicable
law, we do not plan to publicly update or revise any
forward-looking statements contained herein.
DICE THERAPEUTICS,
INC.Condensed Consolidated Statements of
Operations(unaudited)(In thousands, except share and per
share amounts)
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
23,661 |
|
|
$ |
13,410 |
|
General and administrative |
|
|
7,914 |
|
|
|
5,448 |
|
Total operating expenses |
|
|
31,575 |
|
|
|
18,858 |
|
Loss from operations |
|
|
(31,575 |
) |
|
|
(18,858 |
) |
Other income (expense): |
|
|
|
|
|
|
Interest and other income, net |
|
|
5,929 |
|
|
|
327 |
|
Interest expense |
|
|
— |
|
|
|
(60 |
) |
Net loss |
|
$ |
(25,646 |
) |
|
$ |
(18,591 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.54 |
) |
|
$ |
(0.50 |
) |
Weighted-average shares used in
computing net loss per share, basic and diluted |
|
|
47,193,122 |
|
|
|
37,261,685 |
|
|
DICE THERAPEUTICS,
INC.Selected Consolidated Balance Sheet
Data(unaudited)(In thousands)
|
|
March 31,2023 |
|
|
December 31,2022 |
|
Cash, cash equivalents, and marketable securities |
|
$ |
554,548 |
|
|
$ |
574,225 |
|
Total assets |
|
|
575,604 |
|
|
|
593,978 |
|
Total liabilities |
|
|
28,699 |
|
|
|
26,990 |
|
Accumulated deficit |
|
|
(213,240 |
) |
|
|
(187,594 |
) |
Total stockholders'
equity |
|
|
546,905 |
|
|
|
566,988 |
|
Contacts:
Media:Katie Engleman, 1ABkatie@1abmedia.com
Investors:investors@dicetx.com
DICE Therapeutics (NASDAQ:DICE)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
DICE Therapeutics (NASDAQ:DICE)
Gráfica de Acción Histórica
De May 2023 a May 2024