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
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:
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
|
||||||||||||
Three Months Ended
|
Six Months Ended
|
|||||||||||
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
|
||||||
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
[email protected]
Media Contact:
Hal Mackins
For Cortexyme, Inc.
[email protected]
(415) 994-0040