Cassava Sciences Announces Second Quarter 2020 Financial Results and Mid-year Business Review
- Final Clinical Results of a Phase 2b Study in Alzheimer’s Disease with Lead Drug Candidate, PTI-125, Expected to be Announced
- SavaDx Demonstrates Direct Evidence of Target Engagement & Treatment Effects -
- Open-label Study Of PTI-125 Reaches >50% Enrollment -
For the second quarter ended
Update on Market Awareness
Update on Phase 2b Study With PTI-125
In Q2 2020,
As previously reported, the drug was safe and well-tolerated. An outside lab (with whom the Company had no prior work experience) generated an initial bioanalysis in which the study missed its pre-specified primary outcome, defined as a drug effect on cerebrospinal fluid (CSF) levels of tau protein and other biomarker assessments. The data set from that initial bioanalysis showed unnaturally high variability and other problems, such as no correlation among changes in levels of biomarkers over 28 days, even in the placebo group, and different biomarkers of disease moving in opposite directions in the same patient. Overall, we believe data from the initial bioanalysis can be interpreted as anomalous and highly improbable.
We are now conducting a comprehensive analysis of clinical results of our Phase 2b study, including evaluating the effects of PTI-125 on cognition. Data collected from this analysis will constitute final clinical results of our Phase 2b study of PTI-125 in Alzheimer’s disease. We anticipate announcing such results in
“Our Phase 2b study was well-conducted, but we believe the analysis of results is a re-do,” said
Update on Open-label Study with PTI-125 – Initiated in March, Now Over 50% Enrolled
Update on SavaDx
Financial Highlights for Second Quarter 2020
June 30, 2020, cash and cash equivalents were $25.3 million, compared to $23.1 millionat December 31, 2019, with no debt.
- Cash balance included
$3.8 millionin proceeds from exercise of warrants in the first six months of 2020. Approximately 1.4 million warrants remain outstanding, each with an exercise price of $1.25per share. All warrants expire February 2021.
- Net cash used in operations during the six months ended
June 30, 2020was $2.0 million, net of reimbursements received from NIHgrant awards.
- Net cash use for full year 2020 is expected to be approximately
$5.0 million, consistent with previous financial guidance.
- Research grant funding reimbursements of
$1.1 millionwere received from NIHand recorded as a reduction in research and development (R&D) expenses in the second quarter of 2020. This compared to $1.4 millionof NIHgrant receipts received for the same period in 2019.
- R&D expenses were
$0.6 millioncompared to $0.3 millionfor the same period in 2019. The decrease was due primarily to lower NIHreimbursement compared to the prior year.
- General and administrative (G&A) expenses were
$0.8 million, consistent with the same period in 2019.
About Alzheimer's Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. In the
Cassava Sciences’ lead therapeutic product candidate is for the treatment of Alzheimer’s disease. PTI-125 is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science is published in peer-reviewed scientific journals, including
SavaDx is Cassava Sciences’ investigational diagnostic to detect Alzheimer’s disease. The goal of SavaDx is to make the detection of Alzheimer’s as simple as getting a blood test, possibly years before the appearance of any overt clinical symptoms. This clinical-stage program is substantially funded by a research grant award from the
Cassava Sciences’ mission is to discover and develop innovations for chronic, neurodegenerative conditions. Over the past 10 years,
1, 2 Source: Alzheimer’s Association. 2019 Alzheimer’s Disease Facts and Figures. Available online at: https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf
For more information, please visit: https://www.CassavaSciences.com
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Cautionary Note Regarding Forward-Looking Statements: This press release contains “forward-looking statements” for purposes of the Private Securities Litigation Reform Act of 1995 (the Act).
– Financial Tables Follow –
|CONDENSED STATEMENTS OF OPERATIONS|
|(unaudited, in thousands, except per share amounts)|
|Three months ended
||Six months ended
|Research and development, net of grant reimbursement||$||591||$||308||$||1,135||$||882|
|General and administrative||818||845||1,596||1,722|
|Gain on sale of property and equipment||(246||)||—||(346||)||—|
|Total operating expenses||1,163||1,153||2,385||2,604|
|Net loss per share, basic and diluted||$||(0.05||)||$||(0.06||)||$||(0.09||)||$||(0.14||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||24,779||17,162||24,630||17,162|
|CONDENSED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||25,254||$||23,081|
|Other current assets||186||268|
|Total current assets||25,440||23,349|
|Property and equipment, net||13||47|
|Operating lease right-of-use assets||45||90|
|Liabilities and stockholders' equity|
|Accrued development expense||755||777|
|Accrued compensation and benefits||84||58|
|Operating lease liabilities, current||45||90|
|Other accrued liabilities||14||9|
|Total current liabilities||1,314||1,387|
|Common Stock and additional paid-in-capital||195,057||190,686|
|Total stockholders' equity||24,184||22,099|
|Total liabilities and stockholders' equity||$||25,498||$||23,486|
Source: Cassava Sciences, Inc.