– Anticipates Early Information Readout for Section 2b Examine of PTI-125 in Alzheimer’s Illness –
– Roughly $2.9 Million in NIH Analysis Grants Awarded in 2020 –
– Open-Label Examine of PTI-125 Initiated in Alzheimer’s Illness –
AUSTIN, Texas, Could 06, 2020 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology firm targeted on Alzheimer’s illness, immediately introduced latest enterprise highlights and monetary outcomes for the primary quarter ended March 31, 2020. Internet loss was $1.2 million, or $0.05 per share, in comparison with a web lack of $1.four million, or $0.08 per share, for a similar interval in 2019. Internet money utilized in operations was $1.2 million through the first quarter of 2020. Internet money use in full-year 2020 is predicted to be roughly $5 million. Money and money equivalents have been $25.6 million as of March 31, 2020, with no debt.
“Cassava Sciences had a productive quarter with its analysis applications in Alzheimer’s illness,” mentioned Remi Barbier, President & CEO. “Because of this, we anticipate having top-line outcomes for our Section 2b research of PTI-125, our lead drug candidate for Alzheimer’s, sooner than mid-2020.”
Section 2b Examine – Early information readout on results of PTI-125 on tau protein anticipated
In March 2020, Cassava Sciences introduced the completion of a double-blind, randomized, placebo-controlled research of PTI-125 in 64 sufferers with mild-to-moderate Alzheimer’s illness, 50-85 years of age, with 16 ≤ MMSE ≤ 26. Examine members obtained PTI-125 100 mg, 50 mg or matching placebo, twice-daily, for 28 steady days. The first efficacy endpoint is the impact of PTI-125 vs placebo on CSF ranges of tau protein, and different biomarker assessments.
Open-label Examine – Initiated in March, roughly 20% enrolled
In March 2020, Cassava Sciences introduced the initiation of an open-label, multi-center research of PTI-125 at 100 mg twice-daily for 12 months. Each research participant receives drug therapy in an open-label design. This on-going research has a goal enrollment of roughly 100 sufferers with mild-to-moderate Alzheimer’s illness. The research is roughly 20% enrolled.
Finance Replace – $2.9 million of recent NIH analysis grant awards introduced in 2020
Cassava Sciences’ scientific applications proceed to be supported by analysis grant awards from the Nationwide Institutes of Well being (NIH), the nation’s foremost medical analysis company. In April 2020, the Firm introduced it had been awarded a brand new $2,500,000 analysis grant from NIH. In March 2020, NIH awarded the Firm supplemental analysis funding within the quantity of $374,000. The NIH’s Nationwide Institute on Growing older awarded the Firm these analysis grant award following an in-depth, peer evaluate of PTI-125. Peer evaluate, one of many gold requirements of science, is a course of the place unbiased, outdoors scientists consider the deserves of recent analysis.
Operations Replace – No main disruptions thus far
In these instances of pandemic, Cassava Sciences’ prime priorities are to guard the well being, well-being, and security of its workers and companions, whereas nonetheless specializing in the important thing drivers of its enterprise. The corporate believes it stays on-track to realize its main strategic targets for 2020. The Firm has not skilled main disruptions throughout its drug manufacturing operations or provide of supplies. Its broad spectrum of technical consultants, scientific advisors and repair suppliers proceed to supply well timed providers. The Firm has tailored versatile enterprise practices, corresponding to distant work preparations and short-term journey restrictions, to insure it continues to function security and cautiously whereas assembly its public well being tasks.
Cassava Sciences acknowledges the on-going pandemic has created an unstable and unsure state of affairs within the nationwide economic system. The Firm continues to intently monitor the newest data to make well timed, knowledgeable enterprise choices and public disclosures relating to the potential influence of pandemic on its operations. Nevertheless, the scope of this pandemic is unprecedented and its long-term influence on the Firm’s operations and monetary situation can’t be moderately estimated presently.
Monetary Highlights for First Quarter 2020
- At March 31, 2020, money and money equivalents have been $25.6 million, in comparison with $23.1 million at December 31, 2019, with no debt.
- Money steadiness included $3.6 million in proceeds from train of warrants within the first quarter of 2020. Roughly 1.6 million warrants stay excellent, every with an train value of $1.25 per share. All warrants expire February 2021.
- Internet money utilized in operations through the quarter ended March 31, 2020 was $1.2 million, web of reimbursements obtained from NIH grant awards.
- Internet money use for full yr 2020 is predicted to be roughly $5.Zero million, per earlier monetary steering.
- Analysis grant funding reimbursements of $1.Three million have been obtained from NIH and recorded as a discount in analysis and improvement (R&D) bills. This in comparison with $0.eight million of NIH grant receipts obtained for a similar interval in 2019.
- R&D bills have been $0.5 million. This in comparison with $0.6 million for a similar interval in 2019, representing a 5% lower. Whereas Section 2 medical program bills have been greater in Q1 2020, total expense was lowered by larger NIH reimbursement.
- Basic and administrative (G&A) bills have been $0.eight million. This in comparison with $0.9 million for a similar interval in 2019, representing a 11% lower. The lower was due primarily to decrease stock-based compensation expense in comparison with 2019.
Cassava Sciences’ lead therapeutic product candidate is for the therapy of Alzheimer’s illness. PTI-125 is a proprietary, small molecule (oral) drug that restores the traditional form and performance of altered filamin A (FLNA), a scaffolding protein, within the mind. Altered FLNA within the mind disrupts the traditional perform of neurons, resulting in Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science is revealed in peer-reviewed scientific journals, together with Journal of Neuroscience, Neurobiology of Growing older, Journal of Organic Chemistry and Journal of Prevention of Alzheimer’s Illness. The Firm can also be creating an investigational diagnostic, known as SavaDx, to detect Alzheimer’s illness with a easy blood take a look at.
About Alzheimer’s Illness
Alzheimer’s illness is a progressive mind dysfunction that destroys reminiscence and considering abilities. At present, there aren’t any drug therapies to halt Alzheimer’s illness, a lot much less reverse its course. Within the U.S. alone, roughly 5.eight million individuals are at present residing with Alzheimer’s illness, and roughly 487,000 folks age 65 or older developed Alzheimer’s in 2019.1 The variety of folks residing with Alzheimer’s illness is predicted to develop dramatically within the years forward, leading to a rising social and financial burden.2
About Cassava Sciences, Inc.
The mission of Cassava Sciences, Inc. is to detect and deal with neurodegenerative ailments, corresponding to Alzheimer’s illness. Over the previous 10 years, Cassava Sciences has mixed state-of-the-art know-how with new insights in neurobiology to develop novel options for Alzheimer’s illness. Cassava Sciences owns worldwide improvement and business rights to its analysis applications in Alzheimer’s illness, and associated applied sciences, with out royalty obligations to any third-party.
For extra data, please go to: https://www.CassavaSciences.com
1, 2 Supply: Alzheimer’s Affiliation. 2019 Alzheimer’s Illness Info and Figures. Accessible on-line at: https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf
|For Extra Info Contact:
Eric Schoen, Chief Monetary Officer
Cassava Sciences, Inc.
|For Media Inquiries Contact:
Kirsten Thomas, SVP
The Ruth Group
Cautionary Word Concerning Ahead-Wanting Statements: This press launch comprises “forward-looking statements” for functions of the Personal Securities Litigation Reform Act of 1995 (the Act). Cassava Sciences claims the safety of the Secure Harbor for forward-looking statements contained within the Act. All statements apart from statements of historic reality contained on this press launch together with, however not restricted to, anticipated money use in future intervals; statements relating to the standing of medical research with PTI-125; the timing of saying medical outcomes of our Section 2b research; the interpretation of outcomes of medical research, potential well being advantages, if any, of modifications in ranges of biomarkers; verbal commentaries made by Cassava Sciences’ workers; and potential advantages, if any, of the Firm’s product candidates for Alzheimer’s illness are all forward-looking statements. Such statements are primarily based largely on the Firm’s present expectations and projections about future occasions. Such statements converse solely as of the date of this press launch and are topic to a lot of dangers, uncertainties and assumptions, together with, however not restricted to, these dangers regarding the power to conduct or full medical research on anticipated timelines, to show the specificity, security, efficacy or potential well being advantages of our product candidates, the severity and length of well being care precautions given the COVID-19 pandemic, any unanticipated impacts of the pandemic on our enterprise operations, and together with these described within the part entitled “Danger Components” in Cassava Sciences’ Annual Report on Type 10-Okay for the yr ended December 31, 2019 and future reviews to be filed with the SEC. In gentle of those dangers, uncertainties and assumptions, the forward-looking statements and occasions mentioned on this press launch are inherently unsure and will not happen, and precise outcomes may differ materially and adversely from these anticipated or implied within the forward-looking statements. Accordingly, you shouldn’t depend upon forward-looking statements as predictions of future occasions. Besides as required by legislation, the Firm disclaims any intention or accountability for updating or revising any forward-looking statements contained on this press launch. For additional data relating to these and different dangers associated to our enterprise, buyers ought to seek the advice of our filings with the SEC, which can be found on the SEC’s web site at www.sec.gov.
– Monetary Tables Comply with –
|CASSAVA SCIENCES, INC.|
|CONDENSED STATEMENTS OF OPERATIONS|
|(unaudited, in 1000’s, besides per share quantities)|
|Three months ended March 31,|
|Analysis and improvement, web of grant reimbursement||$||544||$||574|
|Basic and administrative||778||877|
|Acquire on sale of property and tools||(100||)||—|
|Complete working bills||1,222||1,451|
|Internet loss per share, fundamental and diluted||$||(0.05||)||$||(0.08||)|
|Weighted-average shares utilized in computing web loss per share, fundamental and diluted||24,481||17,162|
|CONDENSED BALANCE SHEETS|
|(unaudited, in 1000’s)|
|March 31, 2020||December 31, 2019|
|Money and money equivalents||$||25,600||$||23,081|
|Different present belongings||277||268|
|Complete present belongings||25,877||23,349|
|Property and tools, web||33||47|
|Working lease right-of-use belongings||67||90|
|Liabilities and stockholders’ fairness|
|Accrued improvement expense||387||777|
|Accrued compensation and advantages||72||58|
|Working lease liabilities, present||67||90|
|Different accrued liabilities||11||9|
|Complete present liabilities||1,145||1,387|
|Widespread Inventory and extra paid-in-capital||194,569||190,686|
|Complete stockholders’ fairness||24,832||22,099|
|Complete liabilities and stockholders’ fairness||$||25,977||$||23,486|