Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global
biopharmaceutical company developing novel oral small molecule
therapeutics for metabolic and cardiopulmonary diseases, today
reported financial results for the first quarter ended March 31,
2024, and highlighted recent corporate achievements.
“We look forward to our 12 week Phase 2a data for GSBR-1290 in
June, and moving forward with our 36 week Phase 2b obesity study
later this year,” said Raymond Stevens, Ph.D., Founder and CEO of
Structure Therapeutics. “With tremendous unmet need including more
than 100 million people in the United States and more than 800
million people worldwide living with obesity, we believe GSBR-1290
is uniquely positioned as an oral, non-peptide small molecule GLP-1
receptor agonist that can be manufactured at scale and
significantly help address the growing obesity epidemic, which
current peptide GLP-1s are not able to do.”
Upcoming Milestones
GSBR-1290 Oral Small Molecule Selective GLP-1R agonist
for Obesity
- Topline data from the obesity cohort of the Phase 2a study,
including full 12-week efficacy data for 40 participants and safety
and tolerability for all 64 participants, are expected in June
2024.
- In preparation for later stage clinical trials, the company is
conducting a formulation bridging and titration study to evaluate
capsule versus tablet pharmacokinetics (PK) and explore different
titration regimens of GSBR-1290. High level PK study results are
expected in June 2024.
- The Company plans to initiate a global Phase 2b obesity study
of GSBR-1290 in the fourth quarter of 2024.
- The Company plans to initiate a Phase 2 study in T2DM in the
second half of 2024.
Oral Small Molecule GLP-1R Combination Programs: Amylin,
GIPR, Apelin (APJR)
- Oral Small Molecule Amylin Program: The Company is developing
amylin receptor agonists for potential use either alone or in
combination with GLP-1R agonists to treat obesity and associated
diseases, and expects to select a development candidate in the
fourth quarter of 2024.
- Oral Small Molecule GIPR Program: The Company is developing a
GIPR selective agonist and GLP‑1R/GIPR combinations to treat
obesity and associated diseases, and expects to select a
development candidate in the first half of 2025.
- Oral Small Molecule Apelin Receptor (APJR) Program: The Company
is evaluating ANPA-0073, a Phase 2 ready biased APJR agonist for
potential selective or muscle-sparing weight loss. ANPA-0073 is
also being evaluated for idiopathic pulmonary fibrosis (IPF). The
Company has completed a Phase 1 single-ascending and
multiple-ascending dose study, in which ANPA-0073 was generally
well-tolerated with no serious adverse event reported.
Oral Small Molecule LPA1R Program for Idiopathic
Pulmonary Fibrosis (IPF)
- The Company is developing LTSE-2578, an oral small molecule
antagonist that targets lysophosphatidic acid 1 receptor (LPA1R).
Preclinical studies have demonstrated substantial anti-fibrotic
activity in mouse models of fibrotic lung disease, and the Company
expects to initiate a first-in-human study of LTSE-2578 in June
2024.
First Quarter 2024 Financial Highlights
Cash Position: Cash, cash equivalents and
short-term investments totaled $436.4 million on March 31, 2024.
The Company expects its current cash, cash equivalents and
short-term investments to fund projected operations through at
least 2026.
R&D Expenses: Research and development
(R&D) expenses for the first quarter of 2024 were $20.7
million, as compared to $13.1 million for the same period in 2023.
The increase was primarily due to the advancement of the Company’s
GLP-1R franchise and other research programs, clinical study
activities and increases related to employee expenses, primarily
due to an increase in personnel.
G&A Expenses: General and administrative
(G&A) expenses for the first quarter of 2024 were $11.3
million, as compared to $6.5 million for the same period in 2023.
The increase was primarily due to increases in professional
services and employee related expenses as the Company expanded its
infrastructure to drive and support the growth in its operations as
a publicly-traded company.
Net Loss: Net loss for the first quarter of
2024 totaled $26.0 million, with non-cash share-based compensation
expense of $2.7 million, compared to $18.0 million for the first
quarter of 2023 with non-cash share-based compensation expense of
$2.5 million.
About Structure TherapeuticsStructure
Therapeutics is a science-driven clinical-stage biopharmaceutical
company focused on discovering and developing innovative oral small
molecule treatments for chronic metabolic and cardiopulmonary
conditions with significant unmet medical needs. Utilizing its next
generation structure-based drug discovery platform, the Company has
established a robust GPCR-targeted pipeline, featuring multiple
wholly-owned proprietary clinical-stage small molecule compounds
designed to surpass the scalability limitations of traditional
biologic and peptide therapies and be accessible to more patients
around the world. For additional information, please visit
www.structuretx.com.
Forward-Looking Statements This press release
contains “forward-looking statements” within the meaning of the
“safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995. 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
cash runway, the clinical update from the Company’s Phase 2a study
of GSBR-1290 in patients with T2DM and obesity, any expectations
regarding the safety, efficacy or tolerability of GSBR-1290 and
other candidates under development, the ability of GSBR-1290 to
treat T2DM, obesity or related indications, the planned initiation
and study design of the Company’s Phase 2 and Phase 2b studies of
GSBR-1290 in patients with T2DM and obesity and the timing thereof,
and first-in-human study of LTSE-2578 and the timing thereof,
respectively, the selection of a development candidate for the
Company’s amylin receptor agonist program and GIPR and GLP-1R/GIPR
programs, the planned timing of the Company’s data results and
continued development of GSBR-1290, ANPA-0073, amylin, GIPR and
next generation GLP-1R/GIPR combination candidates and expectations
regarding an oral development candidate targeting GLP-1R. 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 risks and uncertainties, which include, without
limitation, risks and uncertainties related to the preliminary
nature of the results due to length of the study and sample size,
the risks that unblinded data is not consistent with blinded data,
the Company’s ability to advance GSBR-1290, LTSE-2578, ANPA-0073
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
impact of any data collection omissions at any of our clinical
sites, the Company’s ability to fund development activities and
achieve development goals, the impact of any global pandemics,
inflation, supply chain issues, rising interest rates and future
bank failures on the Company’s business, its ability to protect its
intellectual property and other risks and uncertainties described
in the Company’s filings with the Securities and Exchange
Commission (SEC), including the Company’s Annual Report on Form
10-K for the year ended December 31, 2023, as filed with the SEC on
March 8, 2024, and future reports the Company may file with the SEC
from time to time. All forward-looking statements contained in this
press release speak only as of the date on which they were made and
are based on management’s assumptions and estimates as of such
date. The Company undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made, except as required by
law.
STRUCTURE THERAPEUTICS INC.Condensed Consolidated
Statements of Operations(unaudited)(In thousands, except
per share amounts) |
|
|
THREE MONTHS ENDED |
|
|
MARCH 31, |
|
|
|
2024 |
|
|
2023 |
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
20,679 |
|
|
$ |
13,135 |
|
General and administrative |
|
|
11,336 |
|
|
|
6,514 |
|
Total operating expenses |
|
|
32,015 |
|
|
|
19,649 |
|
Loss from operations |
|
|
(32,015 |
) |
|
|
(19,649 |
) |
Interest and other income (expense), net |
|
|
6,008 |
|
|
|
1,699 |
|
Loss before provision for income taxes |
|
|
(26,007 |
) |
|
|
(17,950 |
) |
Provision for income taxes |
|
|
29 |
|
|
|
25 |
|
Net loss |
|
$ |
(26,036 |
) |
|
$ |
(17,975 |
) |
STRUCTURE THERAPEUTICS INC.Condensed Consolidated Balance
Sheet Data(unaudited)(In thousands) |
|
|
MARCH 31, |
|
DECEMBER 31, |
|
|
2024 |
|
2023 |
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
436,449 |
|
|
$ |
467,323 |
|
Prepaid expenses and other current assets |
|
|
12,911 |
|
|
|
6,285 |
|
Total current assets |
|
|
449,360 |
|
|
|
473,608 |
|
Property and equipment, net |
|
|
3,120 |
|
|
|
3,228 |
|
Operating right-of-use assets |
|
|
4,698 |
|
|
|
5,136 |
|
Other non-current assets |
|
|
47 |
|
|
|
45 |
|
Total assets |
|
$ |
457,225 |
|
|
$ |
482,017 |
|
Liabilities and shareholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
6,538 |
|
|
$ |
4,742 |
|
Accrued expenses and other current liabilities |
|
|
15,448 |
|
|
|
18,558 |
|
Operating lease liabilities, current portion |
|
|
1,600 |
|
|
|
1,440 |
|
Total current liabilities |
|
|
23,586 |
|
|
|
24,740 |
|
Operating lease liabilities, net of current portion |
|
|
3,525 |
|
|
|
4,013 |
|
Other non-current liabilities |
|
|
296 |
|
|
|
298 |
|
Total liabilities |
|
|
27,407 |
|
|
|
29,051 |
|
Total shareholders’ equity |
|
|
429,818 |
|
|
|
452,966 |
|
Total liabilities and shareholders’ equity |
|
$ |
457,225 |
|
|
$ |
482,017 |
|
|
|
|
|
|
|
|
|
|
Investors:Danielle KeatleyStructure
Therapeutics Inc.ir@structuretx.com
Media:Dan Budwick1ABDan@1abmedia.com
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