— GAIN Trial enrollment on track to complete in
Q4 2020
— GAIN Trial interim analysis on schedule to
complete by year end 2020
— Clinical pipeline expansion anticipated in
2021
Cortexyme, Inc. (Nasdaq: CRTX), a clinical stage
biopharmaceutical company pioneering potential therapeutics for
Alzheimer’s and other degenerative diseases, today announced
financial results for the second quarter 2020 and provided an
update on its business.
“The participation of the medical community and patients in the
GAIN study of atuzaginstat in mild to moderate Alzheimer’s disease
continues to be strong, and we’re entering the final months of
enrollment with key anticipated milestones on track,” said Casey
Lynch, Cortexyme’s chief executive officer, co-founder, and chair.
“We are looking forward to the GAIN interim analysis before the end
of this year, and we anticipate top-line data from the trial in the
fourth quarter of 2021. At the same time, our research efforts
continue to be productive and we are advancing additional molecules
into IND-enabling studies, with the goal of expanding and adding
value to our clinical pipeline in 2021. With a strong balance sheet
and a talented team, we believe we are well positioned to
potentially provide new therapeutic options to patients stricken
with Alzheimer’s and other neurodegenerative diseases.”
GAIN Trial Updates: Evaluating
Atuzaginstat, a New Potential Therapy for Alzheimer’s
Disease
- The Phase 2/3 GAIN Trial of atuzaginstat (COR388) versus
placebo in patients with mild to moderate Alzheimer’s disease (AD)
has surpassed 500 patients enrolled and remains on track to report
top-line results from its final analysis in the fourth quarter of
2021.
- Cortexyme remains on track to conduct an interim analysis in
the GAIN Trial before year end 2020. This interim analysis for
overwhelming efficacy, futility and sample size adjustment will be
conducted after approximately 100 patients in each of the GAIN
Trial’s three arms reach 24 weeks of treatment. The co-primary
endpoints for the GAIN Trial’s interim analysis are change from
baseline in ADAS-Cog11 and CDR-SB versus placebo.
- The GAIN Trial also includes an ongoing open-label extension
(OLE) study in the United States. Upon completing the 48-week
placebo-controlled period of the GAIN Trial, participants in the
GAIN Trial’s placebo and active arms in the U.S. may be eligible to
enroll in the OLE study, where they will receive 40 mg or 80 mg of
atuzaginstat twice daily for an additional 48 weeks. The OLE is
intended to evaluate long-term safety and efficacy measures of
participants in the GAIN Trial.
- A research abstract on the design of the GAIN Trial and its
baseline biomarkers has been accepted as an oral presentation at
the 13th Clinical Trials on Alzheimer’s Disease (CTAD) meeting,
which will be held in a hybrid virtual/onsite format in Boston from
November 4-7, 2020. The abstract, “GAIN Trial Update and Baseline
Biomarkers,” will be presented on November 6th.
Scientific
Updates: Generating New
Evidence and Expanding Our Opportunities to Help
Patients
As atuzaginstat advances through late-stage clinical
development, Cortexyme and external collaborators continue to
present and publish new research and study data to advance the
gingipain hypothesis for Alzheimer’s pathogenesis and identify
additional development opportunities. Recent scientific
presentations and research accomplishments include:
- At the virtual Alzheimer’s Association International
Conference® 2020 (AAIC®) last month, Cortexyme presented three
posters, including new preclinical data in collaboration with the
Forsyth Institute demonstrating the role of the bacterium P.
gingivalis in AD and cardiovascular disease, providing a potential
explanation for why the two diseases often occur together.
Cortexyme also shared data demonstrating the therapeutic potential
of atuzaginstat in treating both diseases.
- The in-life portion of a human radiolabeled mass balance study
for atuzaginstat was completed on schedule and met the goal of
achieving mass balance recovery, completing an important step in a
study required by regulatory authorities for the registration of a
new drug.
- A novel lysine gingipain inhibitor from Cortexyme’s library,
COR588, has been selected to begin IND-enabling studies and is
expected to enter the clinic in 2021. Cortexyme is advancing a
portfolio of gingipain inhibitors toward the clinic with distinct
target therapeutic product profiles and intellectual property.
- Cortexyme completed additional screening of its proprietary
library of small molecules for a possible treatment for
coronaviruses. The Company has identified inhibitors of the 3CL
protease of SARS-CoV-2 that block viral replication in cells.
Cortexyme is continuing to screen analogs for potency, selectivity,
pharmacokinetics and other important properties to identify
potential candidate molecules for further progression.
Financial Results for the Quarter Ended
June 30, 2020
Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents, and short and long-term marketable securities as
of June 30, 2020, were $210.6 million, and includes approximately
$117.6 million of net proceeds raised in Cortexyme’s private
placement offering completed in February 2020. Cortexyme expects
current cash, cash equivalents and marketable securities will be
sufficient to fund its operating and capital expenditures through
2022 and the completion of the GAIN Trial.
Research and Development (R&D) Expenses: For the
quarter ended June 30, 2020, R&D expenses were $14.1 million,
primarily due to costs related to the research and development of
atuzaginstat and the GAIN Trial.
General and Administrative (G&A) Expenses: For the
quarter ended June 30, 2020, G&A expenses were $4.2 million.
The expense was primarily attributable to personnel-related
expenses, insurance, professional and legal fees, and stock-based
compensation.
Net Loss: For the quarter ended June 30, 2020, net loss
was $17.6 million, or a loss of $0.60 per basic share. Weighted
average shares outstanding for the quarter ended June 30, 2020 was
29,442,915.
About Cortexyme, Inc.
Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage
biopharmaceutical company pioneering upstream therapeutic
approaches designed to improve the lives of patients diagnosed with
Alzheimer’s and other degenerative diseases. Based upon the
evidence generated to date, Cortexyme is currently advancing its
lead therapeutic candidate, atuzaginstat (COR388), in the GAIN
Trial, an ongoing Phase 2/3 clinical trial in patients with mild to
moderate Alzheimer’s disease. Cortexyme is targeting a specific,
infectious pathogen found in the brain of Alzheimer’s patients and
tied to neurodegeneration and neuroinflammation in animal models.
To learn more about Cortexyme, visit www.cortexyme.com or follow
@Cortexyme on Twitter.
Forward-Looking
Statements
Statements in this press release contain “forward-looking
statements” that are subject to substantial risks and
uncertainties. Forward-looking statements contained in this press
release may be identified by the use of words such as “anticipate,”
“expect,” “believe,” “will,” “may,” “should,” “estimate,”
“project,” “outlook,” “forecast” or other similar words. Examples
of forward-looking statements include, among others, statements we
make regarding our business plans and prospects, the translation to
humans of pre-clinical data; the pre-clinical results for our
product candidates, the timing and success of our clinical trials
and related data, the potential of atuzaginstat to treat
Alzheimer’s disease and cardiovascular disease, our ability to fund
planned operating and capital expenditures, the timing of
announcements and updates relating to our clinical trials and
related data, the timing of and our ability to enroll patients into
our clinical trials, and the potential therapeutic benefits, safety
and efficacy of our product candidate or library of compounds.
Forward-looking statements are based on Cortexyme’s current
expectations and are subject to inherent uncertainties, risks and
assumptions that are difficult to predict and could cause actual
results to differ materially from what we expect. Further, certain
forward-looking statements are based on assumptions as to future
events that may not prove to be accurate. Factors that could cause
actual results to differ include, but are not limited to, the risks
and uncertainties described in the section titled “Risk Factors” in
our Annual Report on Form 10-K filed with the Securities and
Exchange Commission (SEC) on March 16, 2020, our Quarterly Report
on Form 10-Q filed with the SEC on August 14, 2020, and other
reports as filed with the SEC. Forward-looking statements contained
in this press release are made as of this date, and Cortexyme
undertakes no duty to update such information except as required
under applicable law.
Cortexyme, Inc. Condensed Statements of
Operations (Unaudited) (In thousands, except per share
amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2020
2019
2020
2019
Operating expenses:
Research and development
$
14,086
$
7,109
$
28,467
$
11,934
General and administrative
4,185
2,466
7,662
3,716
Total operating expenses
18,271
9,575
36,129
15,650
Loss from operations
(18,271)
(9,575)
(36,129)
(15,650)
Interest income
659
513
1,341
907
Net loss
(17,612)
(9,062)
(34,788)
(14,743)
Other comprehensive income:
Unrealized gain on available for sales
securities
748
103
651
129
Total comprehensive loss
(16,864)
(8,959)
(34,137)
(14,614)
Net loss per share - basic and diluted
(0.60)
(0.57)
(1.21)
(1.52)
Cortexyme, Inc. Condensed Balance
Sheets (Unaudited) (In thousands, per share amounts)
June 30, 2020
December 31, 2019
ASSETS
Current assets:
Cash and cash equivalents
$
66,156
$
51,214
Short term investments
78,348
48,650
Restricted cash
—
—
Prepaid expenses and other current
assets
7,104
6,192
Total current assets
151,608
106,056
Property and equipment, net
565
709
Operating lease right-of-use assets,
net
686
625
Long term investments
66,107
16,763
Other assets
244
217
Total assets
$
219,210
$
124,370
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
5,091
$
3,075
Accrued expenses and other current
liabilities
8,602
5,817
Short-term lease liability
—
—
Total current liabilities
13,693
8,892
Long-term operating lease liability
50
—
Total liabilities
13,743
8,892
Total stockholders’ equity
205,467
115,478
Total liabilities and stockholders’
equity
$
219,210
$
124,370
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200817005162/en/
Investor Contact: Chris Lowe Cortexyme, Inc. Chief
Financial Officer clowe@cortexyme.com
Media Contact: Hal Mackins For Cortexyme, Inc.
hal@torchcomllc.com (415) 994-0040
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