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 fourth quarter and full year 2019 and provided an update on its business.
"Throughout 2019, Cortexyme made strong progress toward our goal of stemming the tide of Alzheimer's disease by halting its progression," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "As we move through 2020, we are highly focused on the execution of the GAIN Trial, which has enrolled more than 300 patients and for which top-line results are anticipated in Q4 2021. At the same time, we continue to research and publish new data that sheds light on the gingipain hypothesis for Alzheimer's causation and the potential clinical utility of COR388, our lead investigational gingipain inhibitor. With a strong balance sheet and a talented, growing team, we're committed to delivering for all of our stakeholders, especially the neurodegenerative disease patients and caregivers that have been vocal in their calls for new therapeutic options."
Recent Business Updates and Upcoming Milestones
GAIN Trial Updates
Advancing a New Understanding of Alzheimer's Causation and Treatment
As COR388 moves through late-stage clinical development, Cortexyme and external collaborators continue to present and publish new research to advance our understanding of the gingipain hypothesis for Alzheimer's pathogenesis and the clinical potential of COR388.
This spring, Cortexyme's publication and presentation plans include three data sets at meetings that have either been canceled or become virtual events as a result of the evolving COVID-19 situation. Cortexyme expects to be able to share these presentations on the News & Events > Presentations page of its investor website, ir.cortexyme.com, as they are available. These presentations are:
Recent scientific presentations and publications from the fourth quarter of 2019 and early 2020 are detailed below:
Corporate Updates
Financial Results for the Quarter Ended December 31, 2019
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and short and long-term marketable securities as of December 31, 2019, were $116.6 million. In February 2020, Cortexyme completed a successful private placement offering, raising approximately $117.6 million after expenses. Cortexyme expects current cash, cash equivalents and marketable securities plus the net proceeds of the private placement in February 2020 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 December 31, 2019, R&D expenses were $10.0 million. The expense was primarily due to costs related to the research and development of COR388 and the GAIN Trial.
General and Administrative (G&A) Expenses: For the quarter ended December 31, 2019, G&A expenses were $2.9 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 December 31, 2019, net loss was $12.4 million, or a loss of $0.46 per basic share.
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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, cash forecasts, the timing and success of our clinical trials and related data, 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, 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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(Unaudited) |
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(In thousands, except per share amounts) |
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|
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Three Months Ended
|
|
|
Year Ended
|
||
Operating expenses: |
|
|
|
|
|
|
Research and development |
$ |
10,027 |
|
$ |
30,214 |
|
General and administrative |
|
2,922 |
|
|
8,954 |
|
Total operating expenses |
|
12,949 |
|
|
39,168 |
|
Loss from operations |
|
(12,949) |
|
|
(39,168) |
|
Interest income |
|
570 |
|
|
2,188 |
|
Interest expense |
|
? |
|
|
? |
|
Change in fair value of derivative liability |
|
? |
|
|
? |
|
Net loss |
|
(12,379) |
|
|
(36,980) |
|
Other comprehensive income/ (loss): |
|
|
|
|
|
|
Unrealized gain / (loss) on available for sales securities |
|
(36) |
|
|
109 |
|
Total comprehensive income/(loss) |
$ |
(12,415) |
|
$ |
(36,871) |
|
Net loss per share - basic and diluted |
|
(0.46) |
|
|
(1.94) |
Cortexyme, Inc. Condensed Balance Sheets |
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(Unaudited) |
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(In thousands, per share amounts) |
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|
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December 31, |
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|
2019 |
2018 |
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ASSETS |
|
|
|
|
||
Current assets: |
|
|
|
|
||
Cash and cash equivalents |
$ |
51,214 |
$ |
24,872 |
||
Short term investments |
|
48,650 |
|
46,844 |
||
Prepaid expenses and other current assets |
|
6,192 |
|
868 |
||
Total current assets |
|
106,056 |
|
72,584 |
||
Property and equipment, net |
|
709 |
|
283 |
||
Operating lease right-of-use assets |
|
625 |
|
? |
||
Long term investments |
|
16,763 |
|
? |
||
Other assets |
|
217 |
|
10 |
||
Total assets |
$ |
124,370 |
$ |
72,877 |
||
|
|
|
|
|
||
LIABILITIES AND STOCKHOLDERS' EQUITY / (DEFICIT) |
|
|
|
|
||
Current liabilities: |
|
|
|
|
||
Accounts Payable |
|
3,075 |
|
495 |
||
Accrued expenses and other current liabilities |
|
5,817 |
|
962 |
||
Total current liabilities |
|
8,892 |
|
1,457 |
||
Total liabilities |
|
8,892 |
|
1,457 |
||
Redeemable convertible preferred stock |
|
? |
|
104,046 |
||
Total stockholders' equity / (deficit) |
|
115,478 |
|
(32,626) |
||
Total liabilities and stockholders' equity / (deficit) |
$ |
124,370 |
$ |
72,877 |
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