Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage
pharmaceutical company focused on the discovery, development and
commercialization of novel therapeutics for endocrine diseases and
endocrine-related tumors, today reported financial results for the
second quarter ended June 30, 2024.
“The second quarter of 2024 has been yet another
successful period of executing our strategy to become the world’s
premier endocrine company,” said Scott Struthers, Ph.D., Founder
and Chief Executive Officer of Crinetics. “Our strong presence at
the ENDO 2024 meeting in June showcased the breadth and depth of
our pipeline. Our second internally-developed candidate atumelnant*
showed profoundly positive initial results in the treatment of both
congenital adrenal hyperplasia and Cushing’s disease. We anticipate
reporting additional data in both indications later in 2024. Data
presentations from the paltusotine program continue to demonstrate
clinical benefits for patients, providing even more compelling
support for its potential to treat people with acromegaly. We
remain on track for our planned paltusotine NDA filing in
acromegaly later this year, and multiple workstreams are underway
in anticipation of an expected market launch in 2025.”
Crinetics today also announced that Marc Wilson
will be transitioning from his role as Chief Financial Officer for
personal reasons and the Company has initiated a search for a
successor. Mr. Wilson will continue to serve at full capacity until
a successor is named and will provide all necessary support to
ensure a seamless transition.
“Marc has been an invaluable member of the
Crinetics team over the last six years and we thank him for his
outstanding contributions,” said Scott Struthers, Ph.D., Founder
and Chief Executive Officer of Crinetics. “His leadership has been
instrumental in the success of our capital markets activities, the
build-out of our finance and corporate affairs functions, and the
maturation of our organization and culture. During his tenure, we
have successfully raised a significant amount of capital to fund
development of our differentiated pipeline, our rapidly growing
clinical and research programs, and our anticipated commercial
launch.”
“I am proud of what Crinetics has accomplished,
and it has been a privilege to work with such a talented and
dedicated team over the last six years,” said Mr. Wilson. “The
company is in a strong financial position to invest across its deep
pipeline, and I have unwavering confidence in the team’s ability to
continue discovering new, meaningful therapies and advance them
through the clinic to reach as many patients as possible. I will
continue to support the company through this transition and look
forward to following the company’s continued success.”
Second Quarter 2024 and Recent
Highlights:
- Presented positive initial
results from atumelnant studies at the Endocrine Society’s Annual
Meeting (ENDO 2024). In June, Crinetics presented positive
initial results from its ongoing, open-label studies of atumelnant
for the treatment of ACTH-dependent Cushing’s syndrome and
congenital adrenal hyperplasia (CAH) at ENDO 2024 in Boston.
- Presented data from
paltusotine development program at ENDO 2024. In June,
Crinetics presented findings from its paltusotine development
program in acromegaly. Data presented included results of the Phase
3 PATHFNDR-2 trial, a new analysis of patient reported outcome data
from the Phase 3 PATHFNDR-1 trial, and interim long-term efficacy
and safety results at 42 months from the open-label ACROBAT Advance
extension study.
- Selected development
candidates in two programs. Crinetics has identified an
oral parathyroid hormone antagonist development candidate for the
treatment of hyperparathyroidism and IND-enabling studies have
commenced. In addition, a development candidate in the SST3 agonist
program was selected for the treatment of autosomal dominant
polycystic kidney disease.
- Scott Struthers, Ph.D.,
founder and chief executive officer of Crinetics,
was named an Entrepreneur of The Year® 2024 Pacific
Southwest Award winner.
- Strengthened scientific
leadership team. In April, Crinetics appointed Lise Kjems,
M.D., Ph.D. as Senior Vice President of Endocrinology Clinical
Research, and in May, Crinetics appointed Robert M. Cuddihy, M.D.,
as Senior Vice President of Medical Affairs.
Key Upcoming Milestones:
- Topline data and additional data
from the ongoing Phase 2 studies of atumelnant in CAH and
ACTH-dependent Cushing’s syndrome, respectively, are anticipated by
the end of 2024.
- Submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
seeking regulatory approval of paltusotine for the treatment of
acromegaly is on track for the second half of 2024.
- Initiation of a Phase 3 program of
paltusotine for carcinoid syndrome is expected by the end of 2024,
following consultation with the FDA.
- Additional research pipeline
updates are expected by the end of 2024.
Second Quarter 2024 Financial
Results:
- Research and development expenses
were $58.3 million for the three months ended June 30, 2024,
compared to $40.6 million for the same period in 2023. The increase
was primarily attributable to higher personnel costs and
manufacturing and development activities, both of which were driven
by the advancement of our clinical programs and the expansion of
our preclinical portfolio.
- General and administrative expenses
were $24.8 million for the three months June 30, 2024, compared to
$13.3 million for the same period in 2023. The increase was
primarily driven by higher personnel and commercial planning
costs.
- Net loss for the three months ended
June 30, 2024, was $74.1 million, compared to a net loss of $51.0
million for the same period in 2023.
- Revenues were $0.4 million for the
three months ended June 30, 2024, compared to $1.0 million for the
same period in 2023. Revenues during the current year’s quarter
were derived from the paltusotine licensing arrangement with our
Japanese partner, Sanwa Kagaku Kenkyusho.
- Unrestricted cash, cash
equivalents, and investments totaled $863.0 million as of June 30,
2024, compared to $558.6 million as of December 31, 2023. Based on
its current projections, Crinetics expects that its cash, cash
equivalents and short-term investments will be sufficient to fund
its current operating plan into 2028.
Conference Call and Webcast
DetailsManagement will hold a live conference call and
webcast today, Thursday, August 8, 2024 at 4:30 p.m. ET. To
participate, please dial 1-800-267-6316 (domestic) or
1-203-518-9783 (international) and refer to Conference ID CRNXQ2.
To access the webcast, click here. Following the live event, a
replay of the call will be available on the Investors section of
the Company’s website.
*Proposed international nonproprietary name
under review.
ABOUT CRINETICS PHARMACEUTICALS
Crinetics Pharmaceuticals is a clinical stage pharmaceutical
company focused on the discovery, development, and
commercialization of novel therapeutics for endocrine diseases and
endocrine-related tumors. Crinetics’ lead development candidate,
paltusotine, is an investigational, first-in-class, oral,
once-daily somatostatin receptor type 2 (SST2) agonist in Phase 3
clinical development for acromegaly and in Phase 2 clinical
development for carcinoid syndrome associated with neuroendocrine
tumors. Crinetics is also developing atumelnant (CRN04894), an
investigational, first-in-class, oral ACTH antagonist, that is
currently completing Phase 2 clinical studies for the treatment of
congenital adrenal hyperplasia and Cushing’s disease. All of the
company’s drug candidates are orally delivered, small molecule new
chemical entities resulting from in-house drug discovery efforts,
including additional discovery programs addressing a variety of
endocrine conditions such as hyperparathyroidism, polycystic kidney
disease, Graves’ disease (including thyroid eye disease), diabetes,
obesity and GPCR-targeted oncology indications.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
All statements other than statements of historical facts contained
in this press release are forward-looking statements, including
statements regarding the plans and timelines for the clinical
development of atumelnant and paltusotine, including the
therapeutic potential and clinical benefits or safety profile
thereof; the expected timing of an NDA submission to the FDA for
paltusotine for the treatment or maintenance of treatment of
acromegaly in the United States, and the plans and timelines for
the commercial launch paltusotine if approved; the expected timing
of initiation of a Phase 3 program of paltusotine for carcinoid
syndrome and FDA consultation; the expected timing of additional
data and topline results from studies of atumelnant in CAH and
Cushing’s syndrome; the expected timing of additional research
pipeline updates; and the expected timing through which our cash,
cash equivalents, and short-term investments will fund our
operating plans. In some cases, you can identify forward-looking
statements by terms such as “may,” “will,” “should,” “expect,”
“plan,” “anticipate,” “could,” “intend,” “target,” “project,”
“contemplates,” “believes,” “estimates,” “predicts,” “potential,”
“upcoming” or “continue” or the negative of these terms or other
similar expressions. These forward-looking statements speak only as
of the date of this press release and are subject to a number of
risks, uncertainties and assumptions, including, without
limitation, initial or topline data that we report may change
following completion or a more comprehensive review of the data
related to the clinical studies and such data may not accurately
reflect the complete results of a clinical study, and the FDA and
other regulatory authorities may not agree with our interpretation
of such results; we may not be able to obtain, maintain and enforce
our patents and other intellectual property rights, and it may be
prohibitively difficult or costly to protect such rights;
geopolitical events may disrupt Crinetics’ business and that of the
third parties on which it depends, including delaying or otherwise
disrupting its clinical studies and preclinical studies,
manufacturing and supply chain, or impairing employee productivity;
unexpected adverse side effects or inadequate efficacy of the
Company’s product candidates that may limit their development,
regulatory approval and/or commercialization; the Company’s
dependence on third parties in connection with product
manufacturing, research and preclinical and clinical testing; the
success of Crinetics’ clinical studies and nonclinical studies;
regulatory developments in the United States and foreign countries;
clinical studies and preclinical studies may not proceed at the
time or in the manner expected, or at all; the timing and outcome
of research, development and regulatory review is uncertain, and
Crinetics’ drug candidates may not advance in development or be
approved for marketing; Crinetics may use its capital resources
sooner than expected; any future impacts to our business resulting
from geopolitical developments outside our control; and the other
risks and uncertainties described in the Company’s periodic filings
with the Securities and Exchange Commission (SEC). The events and
circumstances reflected in the company’s forward-looking statements
may not be achieved or occur and actual results could differ
materially from those projected in the forward-looking statements.
Additional information on risks facing Crinetics can be found under
the heading “Risk Factors” in Crinetics’ periodic filings with the
SEC, including its annual report on Form 10-K for the year ended
December 31, 2023 and its Quarterly reports on Form 10-Q for the
quarters ended March 31, 2024 and June 30, 2024. You are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof. Except as required by
applicable law, Crinetics does not plan to publicly update or
revise any forward-looking statements contained herein, whether as
a result of any new information, future events, changed
circumstances or otherwise.
CRINETICS PHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED FINANCIAL STATEMENT
DATA(In thousands, except per share data)(Unaudited) |
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
STATEMENTS OF
OPERATIONS DATA: |
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
399 |
|
|
$ |
988 |
|
|
$ |
1,039 |
|
|
$ |
3,667 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
58,344 |
|
|
|
40,640 |
|
|
|
111,685 |
|
|
|
79,108 |
|
General and
administrative |
|
24,838 |
|
|
|
13,343 |
|
|
|
45,666 |
|
|
|
25,532 |
|
Total operating expenses |
|
83,182 |
|
|
|
53,983 |
|
|
|
157,351 |
|
|
|
104,640 |
|
Loss from operations |
|
(82,783 |
) |
|
|
(52,995 |
) |
|
|
(156,312 |
) |
|
|
(100,973 |
) |
Total other income, net |
|
8,728 |
|
|
|
2,016 |
|
|
|
15,797 |
|
|
|
3,999 |
|
Loss before equity method
investment |
|
(74,055 |
) |
|
|
(50,979 |
) |
|
|
(140,515 |
) |
|
|
(96,974 |
) |
Loss on equity method
investment |
|
— |
|
|
|
— |
|
|
|
(470 |
) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(74,055 |
) |
|
$ |
(50,979 |
) |
|
$ |
(140,985 |
) |
|
$ |
(96,974 |
) |
Net loss per share - basic and
diluted |
$ |
(0.94 |
) |
|
$ |
(0.94 |
) |
|
$ |
(1.86 |
) |
|
$ |
(1.79 |
) |
Weighted-average shares -
basic and diluted |
|
79,008 |
|
|
|
54,275 |
|
|
|
75,690 |
|
|
|
54,092 |
|
BALANCE SHEET
DATA: |
June 30,2024 |
|
|
December 31,2023 |
|
|
|
|
|
|
|
Cash, cash equivalents and investments |
$ |
862,953 |
|
|
$ |
558,555 |
|
Working capital |
$ |
820,399 |
|
|
$ |
530,211 |
|
Total assets |
$ |
935,535 |
|
|
$ |
635,353 |
|
Total liabilities |
$ |
104,772 |
|
|
$ |
96,247 |
|
Accumulated deficit |
$ |
(794,687 |
) |
|
$ |
(653,702 |
) |
Total stockholders’
equity |
$ |
830,763 |
|
|
$ |
539,106 |
|
|
|
|
|
|
|
|
|
Investors:Gayathri DiwakarHead of Investor
Relationsgdiwakar@crinetics.com (858) 345-6340
Media: Natalie BadilloHead of Corporate
Communications nbadillo@crinetics.com (858) 345-6075
Crinetics Pharmaceuticals (NASDAQ:CRNX)
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