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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Quince Therapeutics Inc | NASDAQ:QNCX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0814 | -8.19% | 0.912 | 0.91 | 1.11 | 1.07 | 0.93 | 1.03 | 105,089 | 01:00:00 |
— 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
Advancing a New Understanding of Alzheimer’s Causation and Treatment
Corporate Updates
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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