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Texas Biotech Exceeds Alzheimer's Trial Enrollment Target

Source: Vernon Bernardino


November 9, 2023 ( Newswire) This Texas-based biotech company's enrollment in its two pivotal Phase 3 trials evaluating lead drug candidate simufilam for Alzheimer's disease surpassed initial enrollment targets, noted H.C. Wainwright analyst Vernon Bernardino.

Austin, Texas-based Cassava Sciences Inc. (SAVA:NASDAQ) announced it had completed enrollment in its two pivotal Phase 3 trials evaluating lead drug candidate simufilam for Alzheimer's disease (AD), surpassing initial enrollment targets, noted H.C. Wainwright analyst Vernon Bernardino in a November 8 research report.

Robust Enrollment Exceeds Expectations

The Phase 3 studies, named RETHINK-ALZ and REFOCUS-ALZ, were originally designed to enroll 750 and 1,000 AD patients, respectively over one year. However, Cassava completed enrollment of 804 patients in RETHINK-ALZ in just ten months. Meanwhile, REFOCUS-ALZ enrolled a total of 1,125 patients.

According to Bernardino, the robust enrollment numbers "show patient enrollment is exceeding our expectations, and supports our view that there is high interest in simufilam."

Novel Mechanism and Safety Profile Drive Interest

The analyst believes the Alzheimer's community has a significant interest in simufilam given its novel mechanism of action to restore altered filamin A (FLNA) protein to normal, strong safety profile demonstrated so far, and potential to change disease progression shown in Phase 2 trials.

Late-Stage Data Catalysts

Approaching Bernardino expects topline data readouts from the RETHINK-ALZ and REFOCUS-ALZ trials by the end of 2024 and mid-2025, respectively.

He sees Cassava signing a "lucrative" simufilam licensing deal in 2024 based on positive Phase 3 results, with upfront and milestone payments totaling US$1.5 billion.

Interim Safety Data Positive

The analyst also highlighted recent interim MRI data from 180 patients in REFOCUS-ALZ supporting simufilam's safety profile.

The Week 40 brain scans showed no signs of amyloid-related imaging abnormalities (ARIA), which are common side effects of other experimental Alzheimer's drugs like lecanemab.

Bernardino believes this early safety data will help drive simufilam adoption upon approval, with potential for over US$1.8 billion in revenue in the first year. He maintains a Buy rating on Cassava Sciences with a US$124 price target.

Financial Results Beat Expectations

Cassava reported a Q3 net loss of US$25.7 million, beating the analyst's US$37.5 million loss estimate, driven by lower R&D spending.

The company had US$142.4 million in cash at quarter end, providing operational funding through early 2026 based on management projections.

Upside Driven by Clinical Progress

The US$124 price target was based on a probability-adjusted discounted cash flow model, applying a 13% weighted average cost of capital and 65% odds of success.

Key risks include negative clinical trial data, regulatory delays, competition, intellectual property issues, and the need for additional financing.

More Info: Newswire

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