Cassava Sciences Announces Recent Clinical Highlights and Third Quarter 2019 Financial Results
- Phase 2a Study Showed Statistically Significant Decreases (p<0.001) in Clinical Biomarkers of Alzheimer’s Disease -
- Phase 2b Study in Patients with Alzheimer’s Disease Initiated in Multiple Clinical Sites -
- Clinical Results in Alzheimer’s Disease Selected as
Net loss for the third quarter 2019 was
“Cassava Sciences had a productive quarter with our clinical research program in Alzheimer’s,” said
- In September,
Cassava Sciencesreported positive clinical results in Alzheimer’s disease with its lead drug candidate, PTI-125. In a first-in-patient, Phase 2a study funded by the National Institutes of Health(NIH), treatment with PTI-125 for 28 days significantly reduced biomarkers of disease pathology, neuroinflammation and neurodegeneration, consistent with years of basic research and pre-clinical data.
- Key results of the Phase 2a study include: total tau (T-tau) decreased 20% (p<0.001); phosphorylated tau (P-tau) decreased 34% (p<0.0001); neurofilament light chain (NfL), a marker for neurodegeneration, decreased 22% (p<0.0001); neurogranin, a marker for cognitive decline, decreased 32% (p<0.0001); and neuroinflammatory marker YKL-40, an indicator of microglial activation, decreased 9% (p<0.0001). We believe these and other data provide evidence of target engagement in patients with Alzheimer’s disease.
- All evaluable patients showed a biomarker response to PTI-125. The drug was well tolerated, with no observable drug-related adverse events.
- As a result of positive clinical results from its Phase 2a study of PTI-125,
Cassava Sciencesrecently initiated a Phase 2b study. This Phase 2b is designed to evaluate safety, tolerability and drug effects of PTI-125 in Alzheimer’s disease. This blinded, randomized, placebo-controlled, oral dose study will enroll approximately 60 patients with mild-to-moderate Alzheimer’s disease. Patients will be dosed with PTI-125 100 mg, 50 mg or matching placebo, twice daily for 28 continuous days. The primary endpoint is improvement in biomarkers of neurodegeneration and neuroinflammation from baseline to Day 28. The study is supported by a clinical research grant award from NIH.
- In October,
Cassava Sciencesannounced that results of its Phase 2a study of PTI-125 were selected for a late-breaking oral presentation by the 12th International Conferenceon Clinical Trials on Alzheimer’s Disease (CTAD), which takes place December 4-7th, 2019.
September 30, 2019, cash and cash equivalents were $17.8 million, compared to $19.8 millionat December 31, 2018, with no debt.
- Cash used was
$0.7 millionduring the third quarter of 2019, net of reimbursements received from NIH.
- Net cash use for full year 2019 is expected to be
$3.0 - $5.0 million, consistent with previous financial guidance.
- Net loss for the third quarter 2019 was
$0.7 million, or $0.04per share, as compared to a net loss of $1.3 million, or $0.11per share, for the same period in 2018.
- Research grant funding reimbursements of
$1.5 millionfrom NIH were recorded as a reduction in research and development expenses (R&D). This compared to $1.1 millionof NIH grant receipts received for the same period in the prior year.
- R&D expenses, after deducting the grant reimbursement, were negative
$0.1 million. This compared to $0.4 millionfor the same period in the prior year, representing a 112% decrease. The decrease was due primarily to an increase in NIH grant funding in 2019 compared to the prior year, combined with a decrease in non-cash stock-based compensation expense.
- General and administrative expenses were
$0.8 million, consistent with the same period in 2018.
About PTI-125 and Cassava Sciences’ Scientific Approach
The target of PTI-125 is an altered form of filamin A (FLNA), a scaffolding protein. Published studies have shown that altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. Cassava Sciences’ lead drug candidate, PTI-125, is a small molecule that restores the normal shape and function of FLNA in the brain. This action improves the function of certain receptors in the brain and exerts powerful anti-neuroinflammatory effects.
The underlying science for Cassava Sciences’ programs in neurodegeneration is published in several prestigious peer-reviewed technical journals, including
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 U.S. alone, approximately 5.8 million people are currently living with Alzheimer’s disease, and approximately 487,000 people age 65 or older will develop Alzheimer’s in 2019.1 The number of people living with Alzheimer’s disease is expected to grow dramatically in the years ahead, which may also result in a growing social and economic burden.2
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
The mission of
|For More Information Contact:||For Media Inquiries Contact:|
|Eric Schoen, Chief Financial Officer||Kirsten Thomas, SVP|
|Cassava Sciences, Inc.||The Ruth Group|
|(512) 501-2450||(508) 280-6592|
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 –
|CASSAVA SCIENCES, INC.|
|CONDENSED STATEMENTS OF OPERATIONS|
|(unaudited, in thousands, except per share amounts)|
|Three months ended September 30,||Nine months ended September 30,|
|Research and development, net of grant reimbursement||$||(52||)||$||436||$||830||$||2,967|
|General and administrative||831||848||2,553||2,945|
|Total operating expenses||779||1,284||3,383||5,912|
|Net loss per share, basic and diluted||$||(0.04||)||$||(0.11||)||$||(0.18||)||$||(0.69||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||17,162||11,959||17,162||8,498|
|CONDENSED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||17,804||$||19,807|
|Other current assets||385||233|
|Total current assets||18,189||20,040|
|Property and equipment, net||61||87|
|Operating lease right-of-use assets||113||—|
|Liabilities and stockholders' equity|
|Accrued development expense||415||156|
|Accrued compensation and benefits||55||61|
|Operating lease liabilities, current||90||—|
|Other accrued liabilities||7||—|
|Total current liabilities||907||511|
|Operating lease liabilities, non-current||23||—|
|Common Stock and additional paid-in-capital||184,516||183,584|
|Total stockholders' equity||17,445||19,628|
|Total liabilities and stockholders' equity||$||18,375||$||20,139|
Source: Cassava Sciences, Inc.