Cognition Therapeutics Reports Year End 2023 Financial Results and Provides Business Update
- Completion of enrollment in Phase 2 SHINE Study for mild-to-moderate Alzheimer's disease
- Initiation of clinical studies in early Alzheimer's disease and dry AMD
- Publication of scientific manuscripts and presentations at medical congresses
- Appointment of John Doyle as chief financial officer
- FDA approval in 2023 for first disease-modifying biologics for Alzheimer's disease
- Successful public offering raising $10.4 million in March 2024
- Cash runway extended through May 2025 with $29.9 million in cash and equivalents
- Research and development expenses increased to $37.2 million in 2023
- Net loss of $25.8 million reported for 2023
- Increase in research and development expenses compared to 2022
- Net loss of $25.8 million for 2023
- General and administrative expenses increased in 2023
Insights
The announcement from Cognition Therapeutics regarding the progression of its clinical trials and the recent capital raise is significant for investors. The completion of the Phase 2 SHINE Study enrollment is a pivotal step towards advancing CT1812, a potential treatment for Alzheimer's disease. The anticipation of topline results by mid-2024 could serve as a catalyst for the company's stock, as positive outcomes may lead to increased investor confidence and potential partnerships or licensing deals.
Furthermore, the capital raise extending the company's cash runway through May 2025 reduces immediate financial risk, allowing the company to focus on its clinical programs without the immediate need for additional funding. However, the reported net loss and increased R&D expenses reflect the high costs inherent in the biotech industry's clinical development phase. Investors should monitor the burn rate and future financing needs, especially in light of the recent FDA approval of disease-modifying treatments for Alzheimer's, which may affect the competitive landscape.
The FDA's approval of novel biologics for Alzheimer's in 2023 represents a shift in the treatment paradigm, highlighting the importance of Aβ oligomers and protofibrils in disease progression. Cognition's focus on the sigma-2 receptor with CT1812 aligns with the industry's broader interest in targeting underlying disease mechanisms. The data generated from the SHINE and SHIMMER studies may not only contribute to the clinical knowledge base but also potentially identify biomarkers for CT1812 activity.
Understanding the biological impact of CT1812 on Alzheimer's and Parkinson's diseases, as well as dry AMD, could have significant implications for the drug's development trajectory and patient outcomes. The neurology field will be keenly observing the results of these studies for their potential to validate the sigma-2 receptor as a therapeutic target and to provide insights into disease-modifying effects. The long-term success of CT1812 will hinge on its efficacy, safety profile and the ability to differentiate from other treatments in the pipeline.
The strategic financial decisions made by Cognition Therapeutics are important for its sustainability. The follow-on public offering completed in March 2024 has bolstered the company's financial position, providing necessary funds to continue its research endeavors. However, investors should evaluate the dilutive effect of issuing additional shares on the value of existing shares. The net proceeds from the offering, coupled with the remaining grant funds from the National Institute on Aging (NIA), offer a buffer against the company's significant R&D expenditures.
The increase in R&D expenses is expected given the company's active clinical trials, but it's important to assess whether these investments are likely to yield a favorable return. While the company's cash runway has been extended, the ongoing losses highlight the risks inherent in biotech investing. Investors should weigh the potential of the company's drug pipeline against these financial risks and consider the broader market's reception to Alzheimer's and neurological treatments when making investment decisions.
- Topline Results from SHINE Study in Mild-to-Moderate Alzheimer’s Expected mid-2024 -
- On Track to Report Topline Results from SHIMMER Study in Mild-to-Moderate DLB in 2H 2024 -
- 1Q 2024 Capital Raise Extends Cash Runway Through May 2025 -
- Webcast Conference Call Scheduled Today at 8:00 a.m. ET -
PURCHASE, N.Y., March 26, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update. Management will host a live webcast conference call at 8:00am ET to review 2023 accomplishments. Details of the call are provided below.
A number of important clinical milestones were achieved in 2023, including the completion of enrollment in the Company’s Phase 2 SHINE Study in people with mild-to-moderate Alzheimer’s disease. In addition, the company initiated clinical studies in early Alzheimer’s disease and dry age-related macular degeneration (dry AMD). Cognition scientists published two manuscripts and made 11 presentations at medical and scientific congresses in 2023, advancing the understanding of its foundational science and clinical implications.
“We achieved a number of critical clinical objectives in 2023,” said Lisa Ricciardi, Cognition’s president and CEO. “We are pleased with the progress being made with our clinical trial partners to advance our Phase 2 studies. In addition, the scientific data generated by our team has continued to provide insights into proteins and biological processes impacted by CT1812 in Alzheimer’s and Parkinson's diseases as well as dry AMD.”
2023 Corporate and Clinical Highlights:
- Completed enrollment of 153 adults in the Phase 2 SHINE Study of CT1812 in mild-to-moderate Alzheimer’s disease; topline results expected mid-2024
- Continued enrollment in the Phase 2 SHIMMER Study in mild-to-moderate dementia with Lewy bodies (DLB); topline results expected in 2H2024
- Initiated site activation and recruitment in Phase 2 START Study in early Alzheimer’s disease and Phase 2 MAGNIFY Study in geographic atrophy secondary to dry AMD
- Completed Phase 2 SEQUEL Study; reported quantitative electroencephalogram (qEEG) results at Clinical Trials in Alzheimer's Disease congress
- Published manuscripts that provide an extensive review of sigma-2 receptor biology in the International Journal of Molecular Science
- Published results from the Phase 1b SNAP Study of CT1812, which measured target engagement in the journal, Translational Neurodegeneration
- Presented extensive research at scientific and medical congresses from our proteomics research elucidating the pathways involved in sigma-2 receptor modulation in Alzheimer’s and Parkinson’s diseases and dry AMD
- Appointed John Doyle to the role of chief financial officer
“The FDA approval in 2023 of the first disease-modifying biologics for Alzheimer’s disease was a much-needed advance for the development of new drugs to treat Alzheimer’s and other neurological conditions,” said Ms. Ricciardi. “The approval confirmed the role of Aβ oligomers and protofibrils as disease drivers, re-invigorated research into complementary therapeutic approaches, and re-established investment interest in the sector. Building on this momentum, Cognition looks forward to two key milestones in 2024, namely the topline readout from two Phase 2 studies: SHINE in mild-to-moderate Alzheimer's disease and SHIMMER in mild-to-moderate DLB. In addition to cognitive findings, samples from study participants will be analyzed with an expectation that candidate biomarkers of CT1812 activity can be identified. We expect these clinical and biomarker results will inform the next phase of our evolution.”
Recent 2024 Financing
In March 2024, the Company issued and sold 6,571,428 shares of its common stock in an underwritten follow-on public offering, at
2023 Financial Results
Cash and cash equivalents as of December 31, 2023, were approximately
Research and development expenses were
General and administrative expenses were
The Company reported a net loss of
Conference Call Information
Management will host a conference call and live webcast to discuss Cognition’s financial results today at 8:00 a.m. ET. To participate in the conference call, dial (800) 715-9871 (U.S.) or (646) 307-1963 (international) and provide conference ID number 6295507. Alternatively, you may connect to the live webcast via this link: https://edge.media-server.com/mmc/p/q7djwfy4 or by visiting the Investor Relations page of the Cognition website at www.cogrx.com. An archived webcast recording will be available approximately one hour after the conclusion of the live call.
About Cognition Therapeutics:
Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our lead candidate CT1812 in clinical programs in Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at https://cogrx.com/.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials, and cash runway, involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data and pre-clinical studies being predictive of the results of clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts; the impact of the COVID-19 pandemic on our business, supply chain and labor force; and the risks and uncertainties described in the “Risk Factors” section of our annual and quarterly reports filed the Securities Exchange Commission. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
| Cognition Therapeutics, Inc. Unaudited Selected Financial Data | |||||||||
| (in thousands, except share and per share data) | For the Year Ended December 31, | ||||||||
| Consolidated Statements of Operations Data: | 2023 | 2022 | |||||||
| Operating Expenses: | |||||||||
| Research and development | $ | 37,196 | $ | 30,324 | |||||
| General and administrative | 13,528 | 13,227 | |||||||
| Total operating expenses | 50,724 | 43,551 | |||||||
| Loss from operations | (50,724 | ) | (43,551 | ) | |||||
| Other income (expense): | |||||||||
| Grant income | 24,805 | 22,217 | |||||||
| Other income (expense), net | 158 | (35 | ) | ||||||
| Interest expense | (27 | ) | (28 | ) | |||||
| Total other income, net | 24,936 | 22,154 | |||||||
| Net loss | $ | (25,788 | ) | $ | (21,397 | ) | |||
| Unrealized gain (loss) on foreign currency translation | 4 | (1 | ) | ||||||
| Total comprehensive loss | $ | (25,784 | ) | $ | (21,398 | ) | |||
| Net loss per share: | |||||||||
| Basic | $ | (0.86 | ) | $ | (0.91 | ) | |||
| Diluted | $ | (0.86 | ) | $ | (0.91 | ) | |||
| Weighted-average common shares outstanding: | |||||||||
| Basic | 30,029,087 | 23,640,199 | |||||||
| Diluted | 30,029,087 | 23,640,199 | |||||||
| As of | |||||||||
| (in thousands) | December 31, 2023 | December 31, 2022 | |||||||
| Consolidated Balance Sheet Data: | |||||||||
| Cash and cash equivalents | $ | 29,922 | $ | 41,562 | |||||
| Total assets | 35,163 | 50,425 | |||||||
| Total liabilities | 10,689 | 10,176 | |||||||
| Accumulated deficit | (141,189 | ) | (115,401 | ) | |||||
| Total stockholders’ equity | 24,474 | 40,249 | |||||||
| Contact Information: Cognition Therapeutics, Inc. info@cogrx.com | Casey McDonald (media) Tiberend Strategic Advisors, Inc. cmcdonald@tiberend.com | Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com |
FAQ
What are the upcoming milestones for Cognition Therapeutics in 2024?
How much did Cognition raise in the public offering in March 2024?
What was the net loss reported by Cognition for the year ended December 31, 2023?
What is the cash runway for Cognition Therapeutics extended to?
Who was appointed to the role of chief financial officer at Cognition Therapeutics?
What were the research and development expenses for Cognition in 2023?
What important clinical milestones were achieved by Cognition in 2023?
What was the FDA approval related to Alzheimer's disease in 2023 mentioned in the press release?
Where can investors find the archived webcast recording of Cognition's conference call?
