— Lead investigational medicine COR388, a
potentially transformative new paradigm for addressing Alzheimer’s
disease, continues to advance in Phase 2/3 GAIN clinical trial
— Following successful May 2019 initial public
offering, Cortexyme is well capitalized and focused on high quality
execution of the GAIN Trial
Cortexyme, Inc. (Nasdaq: CRTX), a clinical stage
biopharmaceutical company pioneering a novel, disease-modifying
therapeutic approach to treat what it believes to be a key
underlying cause of Alzheimer’s and other degenerative diseases,
today announced financial results for the third quarter 2019 and
provided an update on its business.
“The GAIN Trial has been met with enthusiasm from the
Alzheimer’s clinical and patient communities since its launch this
past spring in the U.S. and, last quarter, in Europe,” said Casey
Lynch, Cortexyme’s chief executive officer, co-founder, and chair.
“We look forward to delivering a steady cadence of milestones in
the coming quarters. Supported by a strong balance sheet and our
experienced and growing professional team, we are well positioned
to advance toward our goal of stemming the tide of Alzheimer’s
disease by halting its progression.”
Recent Business Updates
GAIN Trial
- The GAIN Trial, the company’s Phase 2/3 study of COR388 versus
placebo in patients with mild to moderate Alzheimer’s disease, is
anticipated to continue on track in 2020. The trial is targeting an
enrollment of 570 patients across 90 sites in the United States and
Europe, with top-line results from the trial expected in the fourth
quarter of 2021. In addition, the company is evaluating the
feasibility of conducting an interim analysis, and plans to discuss
this strategy with the U.S. Food and Drug Administration
(FDA).
- In September, Cortexyme announced the start of screening in
Europe for the GAIN Trial. Cortexyme expects to enroll subjects in
five European countries; sites in the UK, Spain, France, and Poland
are already active. An updated listing can be found on
www.clinicaltrials.gov.
Advancing a New Understanding of Alzheimer’s Causation and
Treatment
- Earlier this month, Cortexyme announced that research on
COR388’s impact on ApoE in Alzheimer’s disease patients will be the
subject of an oral presentation at the 12th Clinical Trials on
Alzheimer’s (CTAD) conference, which is being held December 4-7,
2019, in San Diego. Michael Detke, M.D., Ph.D., Cortexyme’s chief
medical officer, will deliver the presentation (abstract OC28) at
10:00 a.m. PST on Saturday, December 7th. Additionally, the company
will host a lunch symposium on Thursday, December 5th, from
12:30-1:30 p.m. PST. More details, including registration info, are
available here.
- In July, COR388 was the subject of a research abstract
presented at the Alzheimer’s Association International Conference
(AAIC) 2019 in Los Angeles. In a Developing Topics poster that was
included in the AAIC press program, researchers highlighted the
Phase 1b clinical development experience of COR388 and provided an
overview of the design for the GAIN trial. AAIC is the largest
international meeting dedicated to advancing dementia science.
- In June, Cortexyme expanded its Clinical Advisory Board (CAB)
with four new key clinical and regulatory experts. The CAB includes
leading experts on Alzheimer’s, neurodegenerative disorders, and
central nervous system drug development. Cortexyme has benefited
from the group’s insights as it advanced COR388 through Phase 1
testing and laid the groundwork for the GAIN trial. Recently,
Cortexyme’s regulatory advisor David Hosford, M.D., Ph.D. rejoined
the FDA Division of Neurology Products. Thomas Laughren, M.D., a
consultant and previous Division Director at the FDA, will now be
advising the company on regulatory matters.
Corporate Updates
- In May, Cortexyme completed a successful initial public
offering, raising approximately $77.8 million after expenses.
Financial Results for the Quarter Ended
September 30, 2019
Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents, and short and long-term marketable securities as
of September 30, 2019, were $127.8 million. Cortexyme expects
current cash, cash equivalents and marketable securities will be
sufficient to fund its operating and capital expenditures through
2021 and the completion of the GAIN Trial.
Research and Development (R&D) Expenses: For the
quarter ended September 30, 2019, R&D expenses were $8.3
million, including $0.6 million of stock-based compensation,
compared to R&D expenses of $2.3 million for the quarter ended
September 30, 2018. The increase was primarily due to costs related
to the research and development of COR388, the GAIN Trial, and
stock-based compensation.
General and Administrative (G&A) Expenses: For the
quarter ended September 30, 2019, G&A expenses were $2.3
million, which included $0.3 million of stock-based compensation.
This compared to G&A expenses of $0.6 million for the quarter
ended September 30, 2018. The increase was primarily attributable
to personnel-related expenses, professional and legal fees, and
stock-based compensation.
Net Loss: For the quarter ended September 30, 2019, net
loss was $9.9 million, or a loss of $0.37 per basic share.
About the GAIN Trial
The GAIN Trial is a Phase 2/3 randomized, double-blind,
placebo-controlled study assessing the efficacy, safety, and
tolerability of two dose levels of COR388 oral capsules in subjects
with mild to moderate AD. The trial is currently enrolling subjects
in the U.S. and Europe, and top-line results from the trial are
anticipated in the fourth quarter of 2021. More information about
the trial can be found at www.GAINtrial.com.
About Cortexyme, Inc.
Cortexyme (Nasdaq: CRTX) is a clinical stage biopharmaceutical
company pioneering a novel, disease-modifying therapeutic approach
to treat what it believes to be a key underlying cause of
Alzheimer’s disease and other degenerative diseases. Cortexyme is
targeting a specific, infectious pathogen found in the brain of
Alzheimer’s patients and tied to neurodegeneration and
neuroinflammation in animal models. The company’s lead
investigational medicine, COR388, is the subject of the GAIN Trial,
an ongoing Phase 2/3 clinical study in patients with mild to
moderate Alzheimer’s. 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.
Forward-looking statements are based on Cortexyme’s current
expectations and are subject to inherent uncertainties, risks and
assumptions that are difficult to predict. 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
the final prospectus related to Cortexyme’s initial public offering
filed with the Securities and Exchange Commission on May 9, 2019
and Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on June 12, 2019. 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 share and per share
amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2019
2018
2019
2018
Operating expenses:
Research and development
$
8,253
$
2,290
$
20,187
$
6,989
General and administrative
2,316
584
6,032
1,288
Total operating expenses
10,569
2,874
26,219
8,277
Loss from operations
(10,569
)
(2,874
)
(26,219
)
(8,277
)
Interest income
711
353
1,618
434
Interest expense
—
—
—
(957
)
Change in fair value of derivative
liability
—
—
—
(206
)
Net loss
(9,858
)
(2,521
)
(24,601
)
(9,006
)
Other comprehensive income/ (loss):
Unrealized gain / (loss) on available for
sales securities
16
(16
)
145
(16
)
Total comprehensive income/(loss)
(9,842
)
(2,537
)
(24,456
)
(9,022
)
Net loss per share - basic and diluted
(0.37
)
(0.75
)
(1.59
)
(2.68
)
Weighted average shares of common stock
outstanding - basic and diluted
26,841,149
3,361,029
15,489,216
3,360,683
Cortexyme, Inc. Condensed Balance Sheets (Unaudited)
(In thousands, except share and per share amounts)
September 30, 2019
December 31, 2018
ASSETS
Current assets:
Cash and cash equivalents
$
44,740
$
24,872
Short term investments
75,730
46,844
Restricted cash
250
—
Prepaid expenses and other current
assets
3,649
868
Total current assets
124,369
72,584
Property and equipment, net
270
283
Right-of-use assets
1,171
—
Long term investments
7,341
—
Other assets
263
10
Total assets
$
133,414
$
72,877
LIABILITIES AND STOCKHOLDERS’ EQUITY /
(DEFICIT)
Current liabilities:
Accounts Payable
$
2,295
$
495
Accrued expenses and other current
liabilities
3,832
962
Total current liabilities
6,127
1,457
Total liabilities
6,127
1,457
Total stockholders’ equity / (deficit)
127,287
(32,626
)
Total liabilities and stockholders’ equity
/ (deficit)
$
133,414
$
72,877
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191112006062/en/
Investor Contact: Chris Lowe Cortexyme, Inc. Chief
Financial Officer clowe@cortexyme.com
Media Contact: Hal Mackins For Cortexyme
hal@torchcomllc.com (415) 994-0040
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