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 third quarter 2020 and provided an update on its business.
“We are pleased with the strong participation in the GAIN Trial and deeply appreciate the support and dedication of patients and the medical community as we approach the interim analysis before the end of this year,” said Casey Lynch, Cortexyme’s chief executive officer, co-founder, and chair. “With a strong balance sheet and a talented team, we remain confident that Cortexyme is well positioned to advance new therapeutic options for patients with Alzheimer’s and other degenerative diseases.”
GAIN Trial Updates: Evaluating Atuzaginstat, a New Potential Therapy for Alzheimer’s Disease
Scientific Updates: Generating New Evidence and Expanding Our Pipeline
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 are the following.
Financial Results for the Quarter Ended September 30, 2020
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and short and long-term marketable securities as of September 30, 2020, were $197.9 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 September 30, 2020, R&D expenses were $17.0 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 September 30, 2020, G&A expenses were $4.9 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 September 30, 2020, net loss was $21.5 million, or a loss of $0.73 per basic share. Weighted average shares outstanding for the quarter ended September 30, 2020 was 29,488,739.
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 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 human of pre-clinical data, the pre-clinical results for our product candidates, the timing and success of our clinical trials and related data including the outcome of the interim analysis, the potential of atuzaginstat to treat Alzheimer’s disease and the potential therapeutic application in oncology, 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 November 12, 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
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||||||||||||||||
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||||
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
$ |
16,983 |
|
|
$ |
8,253 |
|
|
$ |
45,450 |
|
|
$ |
20,187 |
|
|
General and administrative |
|
4,929 |
|
|
|
2,316 |
|
|
|
12,591 |
|
|
|
6,032 |
|
|
Total operating expenses |
|
21,912 |
|
|
|
10,569 |
|
|
|
58,041 |
|
|
|
26,219 |
|
|
Loss from operations |
|
(21,912 |
) |
|
|
(10,569 |
) |
|
|
(58,041 |
) |
|
|
(26,219 |
) |
|
Interest income |
|
406 |
|
|
|
711 |
|
|
|
1,747 |
|
|
|
1,618 |
|
|
Net loss |
|
(21,506 |
) |
|
|
(9,858 |
) |
|
|
(56,294 |
) |
|
|
(24,601 |
) |
|
Other comprehensive income / (loss): |
|
|
|
|
|
|
|
|||||||||
Unrealized gain / (loss) on available for sales securities |
|
(198 |
) |
|
|
16 |
|
|
|
453 |
|
|
|
145 |
|
|
Total comprehensive loss |
$ |
(21,704 |
) |
|
$ |
(9,842 |
) |
|
$ |
(55,841 |
) |
|
$ |
(24,456 |
) |
|
Net loss per share - basic and diluted |
$ |
(0.73 |
) |
|
$ |
(0.37 |
) |
|
$ |
(1.94 |
) |
|
$ |
(1.59 |
) |
Cortexyme, Inc. Condensed Balance Sheets (Unaudited) (In thousands) |
||||||
September 30, 2020 | December 31, 2019 | |||||
ASSETS |
||||||
Current assets: |
||||||
Cash and cash equivalents |
$ |
64,246 |
|
$ |
51,214 |
|
Short term investments |
|
73,548 |
|
|
48,650 |
|
Prepaid expenses and other current assets |
|
5,180 |
|
|
6,192 |
|
Total current assets |
|
142,974 |
|
|
106,056 |
|
Property and equipment, net |
|
500 |
|
|
709 |
|
Operating lease right-of-use assets, net |
|
848 |
|
|
625 |
|
Long term investments |
|
60,133 |
|
|
16,763 |
|
Other assets |
|
209 |
|
|
217 |
|
Total assets |
$ |
204,664 |
|
$ |
124,370 |
|
|
|
|
|
|||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|||
Current liabilities: |
|
|
|
|||
Accounts payable |
$ |
4,309 |
|
$ |
3,075 |
|
Accrued expenses and other current liabilities |
|
12,100 |
|
|
5,817 |
|
Total current liabilities |
|
16,409 |
|
|
8,892 |
|
Long-term operating lease liability |
|
244 |
|
|
— |
|
Total liabilities |
|
16,653 |
|
|
8,892 |
|
Total stockholders’ equity |
|
188,011 |
|
|
115,478 |
|
Total liabilities and stockholders’ equity |
$ |
204,664 |
|
$ |
124,370 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20201112006069/en/
Investor Contact:
Chris Lowe
Cortexyme, Inc.
Chief Financial Officer
[email protected]
Media Contact:
Hal Mackins
For Cortexyme, Inc.
[email protected]
(415) 994-0040