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EXHIBIT 99.1

Filana Therapeutics Reports Q2 2026 Financial Results and Provides Business Update

AUSTIN, Texas, July 29, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company currently focused on developing therapies for Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the second quarter ended June 30, 2026 and provided a business update.

“The Company continues to engage with the FDA regarding the clinical hold on its proof-of-concept trial in TSC-related epilepsy. The Company is working diligently to address the FDA’s request for information in order to have the clinical hold lifted,” said Rick Barry, President and Chief Executive Officer of Filana Therapeutics, Inc. “In the meantime, we continue to work actively with the TSC community. Participation in the TSC World Conference this week will keep us connected and prepared for future development of simufilam as the regulatory process continues.”

Scientific Presentations and Publications

Publication of Eilat XVIII Proceedings in Epilepsia: Peer-reviewed proceedings of the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices (Eilat XVIII) have been published in Epilepsia. The proceedings include a summary of the biological rationale and preclinical data supporting the Company’s simufilam program in TSC-related epilepsy, consistent with the presentation Filana Therapeutics delivered at the conference in Madrid, Spain, on May 5, 2026 (see Section 7 of the published proceedings)1.

TSC Community Engagement

Planned Participation in the 2026 TSC World Conference: Filana is a sponsor of the 2026 TSC World Conference, hosted by the TSC Alliance® and Tuberous Sclerosis Complex International (TSCi), to be held July 30 to August 1, 2026, in Aurora, Colorado. The conference, held every four years, promises to be one of the largest TSC gatherings around the globe, covering all aspects of TSC across a patient’s lifespan.

Financial Results for Second Quarter 2026

Cash and cash equivalents at June 30, 2026 were $82.7 million, compared to $95.5 million as of December 31, 2025. The Company has no debt. Research and development (R&D) expenses for the second quarter of 2026 were $3.3 million. This compared to $5.1 million for the same period in 2025. This 35% decrease was due primarily to the previously reported phase out of the Alzheimer’s disease development program, completed in the second quarter of 2025. Expenses for the TSC-related epilepsy program are expected to be significantly lower compared to those for the Alzheimer’s disease program. General and administrative (G&A) expenses for the second quarter of 2026 were $6.1 million. This compared to $40.3 million for the same period in 2025. The 85% decrease was due primarily to a $31.25 million securities litigation loss contingency recorded in the second quarter of 2025 not being repeated in 2026. Net cash used in operations was $12.7 million during first-half of 2026 and below previous guidance. Litigation Settlement: On July 23, 2026, the Company paid $31.25 million into escrow in connection with the potential settlement of certain securities litigation recorded in 2025. This funding is a step toward final resolution of the matter, and this cash will remain restricted subject to final court approval. Net cash used in operations for second-half 2026 is expected to be in a range from $11 to $15 million, plus the $31.25 million litigation settlement funding described above. The Company estimates unrestricted cash at year-end 2026 in a range from $36 to $40 million. Net loss for the second quarter of 2026 was $8.6 million, or $0.18 per share. This compares to a net loss of $44.2 million, or $0.92 per share, for the same period in 2025. Shares outstanding were 48.3 million as of July 27, 2026.

About TSC and TSC-related Epilepsy

TSC is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2 gene. These mutations affect the mechanistic target of rapamycin (mTOR) pathway and can cause tumors to grow in multiple organs2,3. Epilepsy is the most common health issue affecting the TSC community, with 80% to 90% of TSC patients experiencing seizures4. TSC-related epilepsy affects approximately 45,000 people in the U.S.2,5 Most patients start having seizures within their first year of life5. Even with multiple approved treatments, more than 60% of TSC patients remain refractory to antiepileptic therapy6.

About Filana Therapeutics, Inc.

Filana Therapeutics, Inc. (NASDAQ: FLNA), is a biotechnology company focused on developing novel, investigational therapies to modulate the filamin A protein for the treatment of central nervous system disorders, such as tuberous sclerosis complex (TSC)-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A.

For more information, please visit: https://www.Fil

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EXHIBIT 99.1

Filana Therapeutics Reports Q1 2026 Financial Results and Business Update

AUSTIN, Texas, May 07, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company currently focused on developing therapies for Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the first quarter ended March 31, 2026 and provided a business update on the development of simufilam, an oral small molecule intended to modulate filamin A protein.

“2026 has been a year of important progress and new beginnings for Filana Therapeutics. Our new name reflects who we are—a team dedicated to rigorous science and to bringing new treatment options to patients with TSC-related epilepsy and their families,” said Rick Barry, President and Chief Executive Officer of Filana Therapeutics, Inc. “We believe the recent publication of preclinical data in Epilepsia and our presentation at the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices further support the biological rationale behind simufilam and our approach to the potential treatment of TSC-related epilepsy. We remain focused on generating the necessary data to resolve the FDA’s Clinical Hold and advance the program. We are committed to keeping our stakeholders informed and look forward to sharing updates as they develop.”

Recent Updates:

Corporate Developments

Name Change to Filana Therapeutics: The new name and brand reflect a shared purpose to develop medicines that modulate filamin A – targeting CNS disorders like TSC-related epilepsy and other conditions associated with filamin A dysregulation or overexpression.

Regulatory

TSC Program Update: The Company is actively working to address FDA’s Clinical Hold, including the planned submission of additional pre-clinical data and protocol design modifications. The timeline for initiation of a clinical trial will depend on the Company’s ability to provide the requested information to FDA and on satisfactory completion of FDA’s review.

Scientific Presentations and Publications

Presentation of TSC-Related Epilepsy Program Overview at Eilat XVIII: On May 5, 2026, Filana presented an overview of its TSC-related epilepsy program at the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices (Eilat XVIII) in Madrid, Spain. The presentation highlighted the biological rationale supporting continued evaluation of simufilam in TSC-related epilepsy.

Publication in Epilepsia of Preclinical Simufilam Data: The preclinical data published in Epilepsia showed that simufilam attenuated seizure progression in a well-accepted mouse model of severe TSC-related epilepsy1. The results, together with published findings in an earlier animal model2, underscore a positive correlation between seizure outcomes and plasma exposure to simufilam, supporting the continued evaluation of simufilam for the treatment of TSC-related epilepsy, which affects approximately 45,000 people in the U.S.2,3

Financial Results for First Quarter 2026

Cash and cash equivalents at March 31, 2026 were $86.6 million, compared to $95.5 million as of December 31, 2025. The Company has no debt. The Company estimates cash at June 30, 2026 in a range from $47 to $50 million. Research and development (R&D) expenses were $4.5 million. This compared to $13.7 million for the same period in 2025. This 67% decrease was due primarily to the previously reported phase out of the Alzheimer's disease development program, completed in the second quarter of 2025. Expenses for the TSC-related epilepsy program are expected to be significantly lower compared to those for the Alzheimer's disease program. General and administrative (G&A) expenses were $6.6 million. This compared to $10.9 million for the same period in 2025. The 39% decrease was due primarily to legal loss contingencies of $3.0 million recorded in Q1 2025 not being repeated in 2026. Net cash used in operations was $8.9 million during the first quarter of 2026. Net cash used in operations for first-half 2026 is expected to be in a range from $14 to $17 million, plus a payment of $31.25 million estimated loss contingency related to the potential settlement of certain securities litigation recorded in 2025. Net loss was $10.3 million, or $0.21 per share. This compares to a net loss of $23.4 million, or $0.48 per share, for the same period in 2025. Shares outstanding were 48.3 million as of May 4, 2026.

About TSC and TSC-related Epilepsy

TSC is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2 gene. These mutations affect the mechanistic target of rapamycin (mTOR) pathway and can cause tumors to grow in multiple organs3,4. Epilepsy is the most common health issue affecting the TSC community, with 80% to 90% of TSC patients experiencing seizures5. TSC-related epilepsy affects approximately 45,000 people in the U.S.2,3 Most patients start

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EXHIBIT 99.1

Filana Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results

Working to advance TSC-related epilepsy program, with a focus on capital efficiency

AUSTIN, Texas, March 12, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (formerly Cassava Sciences, Inc.) (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company focused on developing novel medicines to modulate the filamin A protein for the treatment of central nervous system (CNS) disorders, such as Tuberous Sclerosis Complex (TSC)-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A, today reported financial results for the fourth quarter and year ended December 31, 2025, and provided a business update.

Net loss for 2025 was $91.0 million, or $1.88 per share, compared to a net loss of $24.3 million, or $0.53 per share (basic), in 2024. Net cash used in operations was $32.3 million in 2025, consistent with previous guidance.

The Company met cash guidance for year-end 2025, reporting $95.5 million, and estimates cash at June 30, 2026 in a range from $47 to $50 million. The Company estimates net cash use in operations for first half of 2026 in a range from $14 to $17 million, plus a payment of a $31.25 million estimated loss contingency related to the potential settlement of certain securities litigation recorded in 2025.

“At Filana Therapeutics, our name reflects our deep commitment to science and to patients affected by diseases tied to filamin A dysregulation, including TSC-related epilepsy. We are driven by the urgent need for new treatment options that can meaningfully improve patients’ lives,” said Rick Barry, President and Chief Executive Officer of Filana Therapeutics, Inc. “In partnership with our advisors, we are working diligently to address the FDA’s requests and look forward to sharing a progress update in the coming months.”

Corporate Updates:

Name change to Filana Therapeutics, Inc.: Filana Therapeutics’ new name and brand reflect the Company’s strategic focus on developing novel medicines to modulate the filamin A protein for the treatment of CNS disorders, such as TSC-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A. TSC Program Update: The Company is actively addressing FDA’s request for information detailed in the Clinical Hold Letter received in December 2025, including the submission of additional pre-clinical data and protocol design modifications. The Company intends to submit a response to FDA as soon as practicable.

Financial Results for the Fourth Quarter and Full Year 2025:

Cash and cash equivalents were $95.5 million, with no debt, as of December 31, 2025. This compares to cash and cash equivalents of $128.6 million at December 31, 2024. The Company estimates cash at June 30, 2026, in a range from $47 to $50 million. Total shares outstanding as of March 9, 2026, were 48.3 million. Net loss for the year ended December 31, 2025, was $91.0 million, or $1.88 per share. This compares to a net loss of $24.3 million, or $0.53 per share (basic) for the same period in 2024. Net loss increased primarily due to a $108.1 million gain in 2024 from change in fair value of warrant liabilities that was not repeated in 2025. Net cash used in operations was $32.3 million in 2025, consistent with previous guidance. The Company estimates net cash use in operations for first half of 2026 in a range from $14 to $17 million, plus a payment of $31.25 million estimated loss contingency related to the potential settlement of certain securities litigation recorded in 2025. Research and development (R&D) expenses for the year ended December 31, 2025, decreased to $26.6 million from $69.6 million in 2024, representing a 62% reduction. This decrease was due primarily to the phase out of the Alzheimer's disease (AD) development program beginning the fourth quarter 2024 and completed in second quarter 2025. The Company’s planned clinical program in TSC-related epilepsy is expected to cost significantly less than the discontinued AD program. General and administrative (G&A) expenses for the year ended December 31, 2025, decreased to $68.8 million from $71.8 million in 2024. The 4% decrease was due primarily to a $40.0 million SEC-related loss contingency recorded in 2024, which was partially offset by $9.9 million in insurance recoveries. This compared to a $31.3 million securities litigation loss contingency and $4 million of other litigation contingencies recorded in 2025, for which there were no insurance recoveries. The change also included a $2.6 million increase in stock-based compensation expense due to new awards granted in late 2024, as well as cost decreases as severance costs recorded in the prior year were not repeated in 2025.

About TSC and TSC-related Epilepsy

TSC is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2 gene. Thi

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EXHIBIT 99.1

Cassava Reports Q3 2025 Financials Results and Provides Business Update

Simufilam advancing towards a clinical study expected to begin in H1 2026 for the potential treatment of TSC-related epilepsy Further fortified our strategic capabilities with the appointment of Dawn C. Bir to the Board of Directors $106.1 million in cash and cash equivalents at September 30, 2025. Expected to support operations into 2027

AUSTIN, Texas, Nov. 12, 2025 (GLOBE NEWSWIRE) -- – Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the third quarter ended September 30, 2025 and provided a business update.

Net loss was $10.8 million, or $0.22 per share, compared to net loss of $27.9 million, or $0.58 per share, for the same period in 2024. Net cash used in operations was $22.5 million during the first nine months of 2025.

The Company estimates cash at year-end 2025 in a range from $92 to $96 million, including incremental cash use of $10 to $14 million expected in Q4 2025. This represents a downward revision from previous guidance for net cash use in operations for second half 2025. While the Company maintains a $31.25 million estimated loss contingency related to a potential settlement of certain securities litigation recorded in Q2 2025, the timing of such potential settlement payment is unclear. Payment of a potential settlement was previously included in the cash use guidance for 2025.

“2025 has been a year of significant progress for Cassava. We launched a program for simufilam focused on TSC-related epilepsy, building on the results of two sophisticated animal studies that support simufilam’s potential use as a first-in-class treatment. We enhanced our development capabilities with top-tier experts in neuroscience and medicine, and we expanded our Board to strategically guide this important new initiative,” said Rick Barry, President and Chief Executive Officer of Cassava. “We are excited to be working with the TSC Alliance and key opinion leaders in the field of TSC to create a proof-of-concept study which we intend to initiate in the first half of 2026.”

Corporate Highlights: The Company is advancing simufilam as a potential treatment for TSC-related epilepsy, with positive preclinical progress and the appointment of experienced neuroscience leaders.

TSC-related epilepsy (Proof-of-concept study planned for H1 2026)

The program builds on groundbreaking work by Angélique Bordey, PhD, published in Neuron1 and Science Translational Medicine2 which showed treatment with simufilam alleviated neuronal abnormalities and reduced seizure frequency by 60% compared to vehicle in a mouse model of focal onset seizures.

Target indication: Tuberous sclerosis complex (TSC)-related epilepsy. TSC affects approximately 50,000 people in the US and epilepsy is one of the most common neurological features of TSC, occurring in 84% of patients with TSC.3 Positive preclinical data: In addition to the findings from the Bordey lab, simufilam also demonstrated positive preclinical results (August 2025) in a well-accepted mouse model of TSC-related epilepsy provided by the TSC Alliance. Simufilam attenuated the progression of seizure activity with a statistically significant correlation between simufilam dose and the number of seizures by the end of the study. Not all parameters measured reached statistical significance. The study, conducted in collaboration with the TSC Alliance and the TSC Preclinical Consortium, provides further support for the potential use of simufilam as a first-in-class treatment for TSC-related epilepsy. The Company intends to present data and analyses in an upcoming scientific conference and publication. Collaboration: Yale University license agreement (February 2025) Current status: Preparations are underway to initiate a proof-of-concept study in H1 2026 for TSC-related epilepsy, including development of the regulatory strategy. Corporate Updates:

Joseph Hulihan, MD, MSHP, appointed Chief Medical Officer, bringing substantial clinical development experience advancing novel therapies for TSC-related epilepsy and other neurological disorders. Dr. Hulihan will devote approximately half of his professional time to Cassava (August 2025). Ms. Dawn C. Bir appointed as Independent Director, bringing a proven track record of aligning clinical development with strategic commercial goals to the Cassava Board of Directors (October 2025). Financial Results for Third Quarter 2025:

Cash and cash equivalents were $106.1 million, with no debt, as of September 30, 2025. This compares to cash and cash equivalents of $128.6 million as of December 31, 2024. Total shares outstanding as of November 10, 2025 were 48.3 million. Net loss for the q

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Cassava Reports Q2 2025 Financials Results and Provides Business Update

Following positive preclinical data, simufilam development to advance with a clinical study expected to begin in H1 2026 for the potential treatment of TSC-related epilepsy Recent appointment of experienced neuroscience leaders to guide the clinical development strategy for simufilam Advanced settlement negotiations ongoing to resolve certain securities litigation; $31.25 million estimated loss contingency recorded in Q2 for resolution $112.4 million in cash and cash equivalents at June 30, 2025 AUSTIN, Texas, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the second quarter ended June 30, 2025 and provided a business update.

Net loss was $44.2 million compared to net income of $6.2 million for the same period in 2024. Net cash used in operations was $16.3 million during the first half of 2025, consistent with previous guidance. Net cash use in second half 2025 is expected to be $47 to $51 million, which includes a $31.25 million estimated loss contingency related to the potential settlement of certain securities litigation recorded in the second quarter.

“2025 has been transformational for Cassava. We have initiated a new program focused on TSC-related epilepsy, a rare disease for which patients urgently need more treatment options. Two encouraging animal model studies—one conducted at Yale and another with the TSC Alliance—support the exploration of simufilam as a novel, first-in-class approach to this disease,” said Rick Barry, President and Chief Executive Officer of Cassava.

Corporate Highlights: The Company is advancing simufilam as a potential treatment for TSC-related epilepsy, with positive preclinical progress and the appointment of experienced neuroscience leaders.

TSC-related epilepsy (Proof-of-concept study planned for H1 2026)

The program builds on groundbreaking work by Dr. Angélique Bordey, published in Neuron1 and Science Translational Medicine2 which showed treatment with simufilam alleviated neuronal abnormalities and reduced seizure frequency by 60% compared to vehicle in a mouse model of focal onset seizures.

Target indication: Tuberous sclerosis complex (TSC)-related epilepsy. TSC affects approximately 50,000 people in the US.3 Recent Developments: Simufilam demonstrated positive preclinical results in a well-accepted mouse model of TSC-related epilepsy. Simufilam attenuated the progression of seizure activity with a statistically significant correlation between simufilam dose and the number of seizures by the end of the study. Not all parameters measured reached statistical significance. The study, conducted in collaboration with the TSC Alliance and the TSC Preclinical Consortium, provides further support for the potential use of simufilam as a first-in-class treatment for TSC-related epilepsy. The Company intends to present data and analyses in an upcoming scientific conference and publication. Collaboration: Yale University license agreement (February 2025) Current status: Preparations are underway to initiate a proof-of-concept study in H1 2026 for TSC-related epilepsy, including conduct of final pre-IND studies and development of the regulatory strategy. Appointment of Experienced Neuroscience Professionals: Dr. Joseph Hulihan appointed as Chief Medical Officer (CMO), bringing expertise in neurotherapeutics and epilepsy to Cassava. Dr. Hulihan will devote approximately half of his professional time to Cassava, advising on the clinical development of simufilam for the treatment of TSC-related epilepsy. This follows the appointment of Angélique Bordey, PhD, who joined Cassava as Senior Vice President (SVP), Neuroscience, while continuing her tenured academic position at Yale School of Medicine on a part time basis, as well as Jack Moore, PhD, who joined the Company as SVP, Clinical Development.

Financial Results for Second Quarter 2025

Cash and cash equivalents were $112.4 million, with no debt, as of June 30, 2025. This compares to cash and cash equivalents of $128.6 million as of December 31, 2024. Total shares outstanding as of August 12, 2025 were 48.3 million. Net loss for the quarter ended June 30, 2025 was $44.2 million or $0.92 per basic and diluted share. This compares to a net income of $6.2 million or $0.13 per basic and diluted share, for the same period in 2024. Net loss in 2025 included a $31.25 million estimated loss contingency recorded related to the potential settlement of certain securities litigation. Net loss in 2025 also included $4.6 million is stock-based compensation expense, a non cash item, compared to $2.6 million in the same period in 2024. Net

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EXHIBIT 99.1

Cassava Reports Q1 2025 Financials Results, Provides Business Update

License agreement and recent leadership appointments position Cassava to advance development of simufilam in TSC-related epilepsy

$117.3 Million in Cash and Cash Equivalents at March 31, 2025

AUSTIN, Texas, May 08, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders, today reported financial results for the first quarter ended March 31, 2025, and provided a business update.

“Cassava has made significant progress this year in leveraging our science to expand our portfolio. Our license with Yale University for intellectual property rights to potential treatments for certain rare diseases, including TSC-related epilepsy, has laid the groundwork for pursuing new therapeutic applications for simufilam. The appointments of Dr. Angélique Bordey as SVP, Neuroscience, and Dr. Jack Moore as SVP, Clinical Development, position us to advance toward a clinical trial program in TSC with diligence,” said Rick Barry, President and Chief Executive Officer of Cassava. “Our goal is to initiate the first clinical study in TSC-related epilepsy in first-half 2026, following the completion of necessary pre-clinical studies and the development of our regulatory strategy. With a favorable balance sheet, an enhanced team, and a new therapeutic indication for simufilam, we believe Cassava is well situated to move forward in 2025.”

Eric Schoen, Chief Financial Officer of Cassava added, “Cassava remains committed to our mission of developing novel medicines for central nervous system diseases, while maintaining continued strategic expense management. We look forward to updating investors on our progress.”

Portfolio Highlights: Simufilam for TSC-related epilepsy Simufilam is a proprietary, investigational oral small molecule that targets the filamin A protein

Key indications: Tuberous sclerosis complex (TSC)-related epilepsy and other potential CNS indications Current status: Preparations are underway to potentially initiate clinical trials in H1 2026 for TSC-related epilepsy, including conduct of pre-IND studies and development of the regulatory strategy. The program builds on groundbreaking work by Dr. Bordey, published in Neuron and Science Translational Medicine Collaboration: Yale University license agreement (February 2025)

Simufilam for Alzheimer’s disease Simufilam is a proprietary, investigational oral small molecule that targets the filamin A protein

Prior Clinical Focus: Mild-to-moderate Alzheimer’s disease Current status: Each of the RETHINK-ALZ and REFOCUS-ALZ Phase 3 studies did not meet its co-primary endpoints. As a result, Cassava’s Alzheimer’s disease program with simufilam will be completely discontinued by the end of the second quarter of 2025 Corporate Highlights:

Appointed neuroscience experts to advance a new TSC-related epilepsy program. Angélique Bordey, PhD, has joined Cassava as Senior Vice President (SVP), Neuroscience, while continuing her tenured academic position at Yale School of Medicine on a part time basis. Jack Moore, PhD, has joined the Company as SVP, Clinical Development. Cassava also announced the retirement of James W. Kupiec, MD, as Chief Medical Officer, effective May 9, 2025 Implemented cost curtailment program, and reduced its workforce by 10 employees, or approximately 33%, in the first quarter Financial Results for First Quarter 2025

At March 31, 2025, cash and cash equivalents were $117.3 million, with no debt. . Net loss was $23.4 million. This compares to a net income of $25.0 million for the same period in 2024. Net income in 2024 resulted from the change in fair value of warrant liabilities, a non-cash item. Net cash used in operations was $11.3 million during the first quarter of 2025. Net cash used in operations for first half 2025 is expected to be $16 to $20 million, consistent with previous guidance. This includes significant costs for the conclusion of the two Phase 3 trials in Alzheimer’s disease which are not expected to recur in second half 2025. Research and development (R&D) expenses were $13.7 million. This compared to $16.2 million for the same period in 2024. This 16% decrease was due primarily to the discontinuation of clinical trials in Alzheimer's disease beginning the fourth quarter of 2024. This decrease was partially offset by an increase in stock-based compensation expense due to new awards granted in the third quarter of 2024. General and administrative (G&A) expenses were $10.9 million. This compared to $3.7 million for the same period in 2024. The increase was due primarily to legal related expenses which included a $3.0 million estimated loss accrual recorded during the three months ended March 31, 2025. Legal expenses were partially offset by $

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EXHIBIT 99.1

Cassava Sciences Reports 2024 Financial Results and Provides Business Update

Top-line data for REFOCUS-ALZ, the second Phase 3 study of simufilam in Alzheimer’s disease, expected late first-quarter/early second-quarter 2025 License agreement brings potential in a new therapeutic application for simufilam for seizures related to tuberous sclerosis complex (TSC) $128.6 Million in Cash and Cash Equivalents at December 31, 2024

AUSTIN, Texas, March 03, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders, including Alzheimer’s disease and tuberous sclerosis complex (TSC)-related seizures, today reported financial results for the year ended December 31, 2024 and provided a business update.

“Cassava is preparing to report the topline results of the now-discontinued REFOCUS-ALZ, the second Phase 3 study of simufilam in Alzheimer’s disease, in late first-quarter/early second-quarter 2025. We intend to evaluate the next steps for simufilam in Alzheimer’s disease after reviewing the REFOCUS-ALZ results in conjunction with the results of the RETHINK-ALZ study, reported in November 2024, which did not meet the prespecified co-primary endpoints,” said Rick Barry, President and Chief Executive Officer at Cassava. “We are pleased to have entered a licensing agreement with Yale University which allows us to build on the promising research of Angélique Bordey, PhD, Professor of Neurosurgery and Vice Chair of Research, Neurosurgery at Yale, to explore simufilam’s potential as a treatment for TSC-related seizures. We look forward to updating investors on our progress in the coming months.”

Financial Results for the year ended December 31, 2024

At December 31, 2024, cash and cash equivalents were $128.6 million, with no debt. The Company continues its strategic expense management efforts. Net loss was $24.3 million, or $0.53 per share (basic) in 2024. This compares to a net loss of $97.2 million, or $2.32, in 2023. Net loss decreased due primarily to a gain from change in fair value of warrant liabilities. Net cash used in operations was $116.9 million in 2024. Net cash use in operations for first half 2025 is expected to be $16 to $20 million, including significant costs for the conclusion of the two Phase 3 trials in Alzheimer’s disease which will not recur in second half 2025. Research and development (R&D) expenses were $69.6 million in 2024. This compared to $89.4 million for 2023. R&D expenses decreased due primarily to the completion of enrollment for our Phase 3 Alzheimer’s disease clinical program for simufilam in the fall of 2023. R&D expenses in 2024 primarily related to support for the two Phase 3 studies and open label extension studies. Discontinuation of all Alzheimer’s disease clinical studies was initiated following the November 25, 2024 announcement that the RETHINK-ALZ study did not achieve the prespecified co-primary endpoints. Decreases in R&D expenses in 2024 were partially offset by a $4.4 million increase in stock-based compensation expense due to new grant awards in 2024. General and administrative (G&A) expenses were $71.8 million in 2024. This compared to $16.5 million for 2023. G&A expenses increased due primarily to payment of the $40 million settlement with the Securities and Exchange Commission (SEC) as well as a $7.3 million increase in stock-based compensation expense due to new grant awards in late 2023 and 2024, increased compensation costs and higher legal related expenses. Total common shares outstanding as of February 27, 2025 were 48.3 million. Going forward, rather than conducting quarterly earnings conference calls, the Company plans on hosting investor calls that focus on corporate or clinical updates. About Simufilam

Simufilam is a proprietary, investigational oral small molecule that targets the filamin A protein.

About REFOCUS-ALZ

REFOCUS-ALZ (NCT05026177) is a Phase 3 trial designed as a multi-center, double-blinded, placebo-controlled, randomized parallel group study to evaluate the safety and efficacy of two doses of simufilam compared to a placebo in a study involving over 75 clinical trial sites in the U.S., Canada, Puerto Rico and South Korea. The clinical trial sites that conducted REFOCUS-ALZ were completely distinct from the clinical trial sites that conducted RETHINK-ALZ. REFOCUS-ALZ randomized approximately 1,125 people utilizing the same eligibility criteria as RETHINK-ALZ. Subjects were randomized 1:1:1 to receive simufilam, dosed in 50 mg or 100 mg tablets, or a matched placebo, dosed orally twice daily (BID) for 76 weeks. On November 25, 2024, the Company announced plans to discontinue the REFOCUS-ALZ study and its intention to report topline data from that trial, including the complete 52-week dataset and a large portion of

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EXHIBIT 99.1

Cassava Sciences Provides a Business Update

Topline data from Phase 3 REFOCUS-ALZ study of simufilam in patients with mild-to-moderate Alzheimer’s disease expected late first-quarter/early second-quarter 2025

Implementing cost curtailment including a workforce reduction of approximately 33%

Approximately $128.6 million cash and cash equivalents at December 31, 2024 (unaudited)

AUSTIN, Texas, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage biotechnology company focused on developing novel, investigational treatments for central nervous system diseases including Alzheimer’s disease dementia, today provided a business update.

In November 2024, Cassava reported that the topline results from the Phase 3 RETHINK-ALZ study evaluating simufilam as a potential treatment for patients with mild-to-moderate Alzheimer’s disease did not meet its prespecified co-primary endpoints and that the Company intended to share a detailed analysis of data from the study at a future medical meeting. The Company also outlined its plan to discontinue the Phase 3 REFOCUS-ALZ study and Open Label Extension study and to analyze the complete 52-week dataset from the REFOCUS-ALZ study, along with a large portion of 76-week data. The Company is on track to complete these efforts and plans to release top-line REFOCUS-ALZ results late first-quarter/early second-quarter 2025.

The Company today announced that it is reducing its workforce by 10 employees, or approximately 33%, in the first quarter of 2025, as well as continuing strategic expense management efforts. Expense reductions include halting the planned biomarker analysis of additional plasma samples from prior Phase 2 studies. The Company estimates that it will incur approximately $0.4 million of one-time costs in Q1 2025 related to the workforce reduction.

The Company’s unaudited cash and cash equivalents balance as of December 31, 2024 was approximately $128.6 million.

“Cassava continues to be dedicated to its mission of developing novel medicines for central nervous system disorders and enhancing shareholder value. We are in the final stages of discontinuing the REFOCUS-ALZ study and expect to report topline results late first-quarter/early second-quarter 2025. In addition, we continue to carefully review the data from the RETHINK-ALZ study and plan to incorporate the results of the REFOCUS-ALZ study into our evaluation of next steps for Cassava. With that in mind, following the announcement that the RETHINK-ALZ study did not meet its primary endpoints and that the REFOCUS-ALZ and Open Label Extension studies will be discontinued, we believe it is prudent to implement additional cost saving measures, including a reduction in force,” said Rick Barry, President and Chief Executive Officer. “Cassava is a closely-knit organization, and so I want to thank each one of our employees being affected by this workforce reduction. We recognize and appreciate with deep and heartfelt gratitude your fine and dedicated service to Cassava’s mission, to our clinical programs and to patients with Alzheimer’s disease.”

About RETHINK-ALZ

RETHINK-ALZ (NCT04994483) is a Phase 3 trial designed to evaluate the safety and efficacy of simufilam compared to a placebo in a multi-center, double-blinded, placebo-controlled, randomized parallel group study involving over 75 clinical trial sites in the U.S., Canada and Australia. The trial randomized 804 people with confirmed mild or moderate Alzheimer’s disease, as defined by several well validated parameters including a mini-mental state exam (MMSE) of >16 and <27, stratified as mild or moderate. Subjects were randomized 1:1 to receive a 100 mg tablet of simufilam (n=403) or a matched placebo (n=401), dosed orally twice daily (BID) for 52 weeks. On November 25, 2024, the Company reported that the RETHINK-ALZ study did not meet the co-primary endpoints for the study. The Company also indicated that it planned to fully analyze the results and share the data at a future medical meeting.

The co-primary endpoints for this study included the change in cognition and function from baseline to the end of the double-blind treatment period at week 52, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo. Secondary endpoints included several well validated measures of neuropsychiatric symptoms and caregiver burden. Safety was evaluated by adverse event monitoring, as well as standard laboratory and ECG assessments. The study also included a pharmacokinetic and plasma biomarker sub-study comprised of approximately 100 subjects, evaluated at three timepoints. RETHINK-ALZ was conducted under a Special Protocol Assessment (“SPA”) with the U.S. Food and Drug Administration (“FDA”).

REFOCUS-ALZ (NCT05026177) is a Phase 3 trial designed as a multi-center, double-blinded, placebo-controlled, randomized parallel grou

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Cassava Sciences Reports Q3 2024 Financial and Operating Results

Top-line Data for RETHINK-ALZ 52-week Phase 3 trial Expected Before the End of 2024

$149.0 Million in Cash and Cash Equivalents at September 30, 2024. Expected To Support Operations Into 2026 Conference Webcast Scheduled for Today at 8:30AM ET AUSTIN, Texas, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on developing a novel treatment for Alzheimer’s disease, today reported financial results for the third quarter ended September 30, 2024.

“We look forward to the release of top-line results from RETHINK-ALZ, our first Phase 3 trial for simulfilam, by the end of 2024,” said Rick Barry, President and Chief Executive Officer. “This will represent the culmination of three-plus years of concerted effort by our clinical team, principal investigators, patients and their caregivers.”

Current Updates on Phase 3 Clinical Program Background - Our Phase 3 program consists of two global, double-blind, randomized, placebo-controlled studies of simufilam, an investigational agent in development for the potential treatment of patients with mild-to-moderate Alzheimer’s disease (“Alzheimer’s” or “AD”). The program’s goal is to evaluate the overall safety and efficacy of oral simufilam, administered twice-daily, versus placebo, in a large population of people with Alzheimer’s disease over 12 and 18 months.

The target study population is people with mild-to-moderate Alzheimer’s (mini-mental state examination, (MMSE) score of 16-27) who are biomarker-positive for Alzheimer’s disease pathology and who meet other inclusion/exclusion eligibility criteria of the study protocols.

Phase 3 Trials – Our first Phase 3 study, RETHINK-ALZ (NCT04994483), is designed to evaluate the safety and efficacy of simufilam 100 mg tablets administered twice-daily versus matching placebo over 52 weeks. Our second Phase 3 study, REFOCUS-ALZ (NCT05026177), is designed to evaluate the safety and efficacy of two doses of oral simufilam tablets, 100 mg and 50 mg, administered twice-daily, versus matching placebo, over 76 weeks. Clinical sites are in the United States, Canada, Puerto Rico, Australia, and South Korea.

Patient Enrollment – Both Phase 3 studies are fully enrolled. Approximately 1,900 patients are randomized in these studies, with approximately 800 patients randomized into RETHINK-ALZ and approximately 1,100 patients randomized into REFOCUS-ALZ. Approximately 90% of patients are recruited from clinical sites in the U.S. and Canada. The overall drop-out rate was 21% for RETHINK-ALZ and has been 25% for REFOCUS-ALZ; these numbers are generally consistent with expectations.

Patient Completion – The Last Patient/Last Visit (LPLV) occurred several weeks ago for the RETHINK-ALZ study, with approximately 635 patients completed. To date, over 550 patients have completed the REFOCUS-ALZ study, for a total of over 1,185 completers.

Data and Safety Monitoring Board (DSMB) – The DSMB is composed of independent clinical research experts who periodically review interim patient safety data. Following a third routine, scheduled meeting in September 2024, the DSMB recommended that both of our Phase 3 studies continue as planned, without modification. This was consistent with recommendations of the DSMB following meetings in September 2023 and March 2024.

Co-primary Efficacy Outcomes – The pre-specified efficacy endpoints for the Phase 3 studies are Alzheimer’s Disease Assessment Scale-Cognitive subscale 12 (ADAS-Cog12), a cognitive scale, and Alzheimer’s Disease Cooperative Study – Activities of Daily Living subscale, (ADCS-ADL), a functional scale.

Phase 3 Efficacy Results – All efficacy data from our Phase 3 program remain blinded. No interim analyses on efficacy outcomes are planned. We expect to report top-line data for RETHINK-ALZ before the end of 2024. We anticipate a top-line data readout for REFOCUS-ALZ approximately mid-year 2025.

Open-label Extension Study – This study is designed to provide no-cost access to oral simufilam to Alzheimer’s patients who have successfully completed a Phase 3 study of simufilam and who meet other entry criteria. Approximately 88% of patients who have completed treatment in one of the two Phase 3 studies, RETHINK-ALZ or REFOCUS-ALZ, have opted to enter the open-label extension (OLE) study. To date, over 1,040 patients have entered the OLE study. The OLE study is intended to continue for up to 36 months or until a new drug application for simufilam has been reviewed by FDA. Cassava also plans to add cognition and plasma biomarker monitoring to its OLE trial for patients who have completed either of the two Phase 3 trials, in order to gather additional long-term data on the potential impact of simufilam treatment.

Financial Results for Third Quarter 2024

At September 30, 2024, cash and cash equivalents were $14

sava20240809_8ka.htm

Form 8-K/A date of report 08-08-24 true 0001069530

0001069530

2024-08-08 2024-08-08

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K/A

(Amendment No. 1)

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) August 8, 2024

Cassava Sciences, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-41905

91-1911336

(State or other jurisdiction

of incorporation)

(Commission File Number)

(I.R.S. Employer Identification Number)

6801 N Capital of Texas Highway, Building 1; Suite 300

Austin, Texas 78731

(Address of principal executive offices, including zip code)

(512) 501-2444

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

☐

Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17CFR 240.14d-2(b))

☐

Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value

SAVA

Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Explanatory Note

This Amendment No. 1 to the Current Report on Form 8-K (“Amendment”) of Cassava Sciences, Inc. (the “Company”) is being filed to amend the Current Report on Form 8-K furnished on August 8, 2024 (the “Initial 8-K”) announcing the Company’s financial results for the quarter ended June 30, 2024 solely for the purpose of correcting an error in the Net income (loss) per share, diluted presented for the Six months ended June 30, 2024. No other figures or information in the Initial 8-K are impacted by this correction and no other changes are made to the Initial 8-K.

Item 2.02. Results of Operations and Financial Condition.

On August 8, 2024, the Company issued a press release announcing financial results for the quarter ended June 30, 2024 (the “Earnings Release”). Within the financial tables included in the Earnings Release, the Company incorrectly presented Net income (loss) per share, diluted for the Six months ended June 30, 2024 as $(1.72). The Company is filing this Amendment to provide the corrected Net income (loss) per share, diluted for the Six months ended June 30, 2024 of $(0.28), which was correctly presented in the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2024 filed with the Securities and Exchange Commission on August 8, 2024.

The information provided in this Amendment is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. Such information shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in such filing.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

CASSAVA SCIENCES, INC.

Date: August 9, 2024

By:

/s/ Eric J. Schoen

Eric J. Schoen

Chief Financial Officer

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Cassava Sciences Reports Q2 2024  Financial Results and Operational Updates

$207.3 Million in Cash and Cash Equivalents at June 30, 2024. Company in Advanced Discussions to Resolve SEC Investigation. $40 Million Estimated Loss Contingency Recorded in Q2 for Resolution. Conference Webcast Scheduled for Today at 8:30AM ET.

AUSTIN, Texas, Aug. 08, 2024 (GLOBE NEWSWIRE) --  Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on a novel treatment for Alzheimer’s disease, today reported financial results for the second quarter ended June 30, 2024. Net income was $6.2 million compared to a net loss of $26.4 million for the same period in 2023. Net cash used in operations was $37.4 million during the first half of 2024, consistent with previous guidance. Net cash use in second half 2024 is expected to be $80 to $90 million, which includes an estimated $40 million loss contingency related to advanced discussions to resolve the SEC’s investigation of the Company recorded in the second quarter.

“We have made significant progress over the last few months,” Rick Barry, Cassava’s Executive Chairman said. “The Cassava Clinical Operations team in conjunction with Premier Research have done a brilliant job in executing our Phase 3 program. We expect our last patient/last visit for our ReTHINK trial in early Q4 and a top-line read out from the trial by year-end. We also expect our second Phase 3 trial, ReFOCUS, to read out in mid-year 2025. The success of our warrant program earlier in the second quarter – which provided over $123 million net in equity capital to Cassava – has provided the Company with a strong balance sheet with enough liquidity to get well past our Phase 3 readouts. We are very grateful for the confidence that investors, principal investigators, patients and their loved ones have shown in Cassava. Our team’s urgent focus is to deliver a best-in-class therapy for Alzheimer’s patients.”

Current Updates on Phase 3 Clinical Program Background - Our Phase 3 program consists of two global, double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. The goal is to evaluate overall risk/benefit for oral simufilam twice-daily versus placebo in a large population of people with Alzheimer’s disease over 12 and 18 months.

The target study population is people with mild-to-moderate Alzheimer’s (MMSE score of 16-27) who are biomarker-positive for Alzheimer’s disease pathology, and who meet other inclusion/exclusion eligibility criteria of the study protocols.

Phase 3 Trials – Our first Phase 3 study, called RETHINK-ALZ, is designed to evaluate the safety and efficacy of simufilam 100 mg tablets twice-daily versus matching placebo over 52 weeks (NCT04994483). Our second Phase 3 study, called REFOCUS-ALZ, is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg tablets twice-daily versus matching placebo over 76 weeks (NCT05026177). Clinical sites are in the United States, Canada, Puerto Rico, Australia, and South Korea. Premier Research International is the clinical research organization (CRO) supporting the conduct of our Phase 3 clinical program.

Patient Enrollment – Both Phase 3 studies are fully enrolled. Approximately 1,900 patients are randomized in these studies, with approximately 800 patients randomized in the 52-week study (RETHINK-ALZ) and approximately 1,100 patients randomized in the 76-week study (REFOCUS-ALZ). Approximately 90% of patients are recruited from clinical sites in the U.S. and Canada. The overall drop-out rate for both Phase 3 studies is in the range of 20% to 23%, which is generally consistent with expectations. A longer study will generally have a higher dropout rate versus a similar shorter study.

Patient Completion – Over 555 patients have completed the 52-week RETHINK-ALZ study. Over 420 patients have completed the 76-week REFOCUS-ALZ study, for a total of over 975 completers.

Data and Safety Monitoring Board (DSMB) – The DSMB is composed of independent clinical research experts who periodically review interim patient safety data. Routine, scheduled DSMB meetings were held September 2023 and March 2024. Both DSMB meetings recommended that the Phase 3 studies continue as planned, without modification.

Co-primary Efficacy Outcomes – The pre-specified efficacy endpoints for the Phase 3 studies are ADAS-Cog12, a cognitive scale, and ADCS-ADL, a functional scale.

Phase 3 Efficacy Results – All efficacy data from our Phase 3 program remain blinded. No interim analyses on efficacy outcomes are planned. We anticipate top-line data readout for our 52-week study (RETHINK-ALZ) by the end of 2024. We anticipate top-line data readout for our 76-week study (REFOCUS-ALZ) approximately mid-year 2025.

Open-label Extension Study – This study is designed to provide no-cost access to oral simufilam to Alzheimer’s patient

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Cassava Sciences Reports Q1 2024 Financial Results and Clinical Updates on Phase 3 Trials of Simufilam

$126.3 Million In Total Gross Proceeds from Warrant Distribution.

Over 1,900 Patients with Alzheimer’s Disease Are Randomized in Phase 3 Trials of Simufilam.

Over 735 Patients Have Completed a Phase 3 Trial of Simufilam. AUSTIN, Texas, May 10, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today reported financial results for first quarter ended March 31, 2024. Net income was $25.0 million compared to a net loss of $24.3 million for the same period in 2023. Net cash used in operations was $19.1 million during the first quarter of 2024. Cash use for operations for the first half of 2024 is still expected to be $35 to $45 million, driven primarily by expenses for our clinical program in Alzheimer’s disease.

Current Updates on Phase 3 Clinical Program Background - Our Phase 3 program consists of two global, double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. The goal is to evaluate overall risk/benefit for simufilam 100 mg twice-daily versus placebo in a large population of people with Alzheimer’s disease over 12 and 18 months.

The target study population is people with mild-to-moderate Alzheimer’s (MMSE score of 16-27) who are biomarker-positive for Alzheimer’s disease pathology, and who meet other inclusion/exclusion eligibility criteria of the study protocols.

Phase 3 Trials – Our first Phase 3 study, called RETHINK-ALZ, is designed to evaluate the safety and efficacy of simufilam 100 mg tablets twice-daily versus matching placebo over 52 weeks (NCT04994483). Our second Phase 3 study, called REFOCUS-ALZ, is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg tablets twice-daily versus matching placebo over 76 weeks (NCT05026177). Clinical sites are in the United States, Canada, Puerto Rico, Australia, and South Korea. Premier Research International is the clinical research organization (CRO) supporting the conduct of our Phase 3 clinical program.

Patient Enrollment – Both Phase 3 studies are fully enrolled. Approximately 1,900 patients are randomized in these studies, with approximately 800 patients randomized  in the 52-week study (RETHINK-ALZ) and approximately 1,100 patients randomized  in the 76-week study (REFOCUS-ALZ). Approximately 90% of patients are recruited from clinical sites in the U.S. and Canada. The overall drop-out rate for both Phase 3 studies is in the range of 20% to 22%, which is generally consistent with expectations. (A longer study will generally have a higher dropout rate versus a similar shorter study).

Patient Completion – Over 435 patients have completed the 52-week RETHINK-ALZ study. Over 300 patients have completed the 76-week REFOCUS-ALZ study, for a total of over 735 completers.

Data Safety and Monitoring Board (DSMB) – The DSMB is composed of independent clinical research experts who periodically review interim patient safety data. Routine, scheduled DSMB meetings were held September 2023 and March 2024. Both DSMB meetings recommended that the Phase 3 studies continue as planned, without modification.

Co-primary Efficacy Outcomes – The pre-specified efficacy endpoints are ADAS-Cog12, a cognitive scale, and ADCS-ADL, a functional scale. iADRS is a combination of scores from ADAS-Cog and ADCS-ADL. Because the distribution of study participants is numerically skewed towards mild patients, we expect to rely predominantly on mild patients to evaluate drug safety and efficacy.

Phase 3 Efficacy Results – All efficacy data from our Phase 3 program remain blinded. No interim analyses on efficacy outcomes are planned. We anticipate top-line data readout for our 52-week study (RETHINK-ALZ) approximately year-end 2024. We anticipate top-line data readout for our 76-week study (REFOCUS-ALZ) approximately mid-year 2025.

Open-label Extension Study – This study is designed to provide no-cost access to oral simufilam for up to one year to Alzheimer’s patients who have successfully completed a Phase 3 study of simufilam and who meet other entry criteria. Approximately 90% of patients who’ve completed treatment in a Phase 3 study have opted to enter the open-label extension study. To date, over 655 patients have entered the open-label extension study.

Financial Results for First Quarter 2024

At March 31, 2024, cash and cash equivalents were $124.2 million, with no debt. The total gross proceeds received from the cash-exercise of Warrants were $126.3 million, including approximately $104.0 million received in April and May 2024. Net income was $25.0 million compared to a net loss of $24.3 million for the same period in 2023. Net income resulted from the change in fair value of warrant liabilities, a non-cash item. This warrant gain was parti

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Cassava Sciences Reports Full-year 2023 Financial Results and Corporate Updates

$121.1 Million In Cash and Cash Equivalents at December 31, 2023, With an Additional $21.8 Million Raised In 2024 From Exercise of Warrants.

A Total of Over 555 Study Participants Have Completed Our Phase 3 Studies. Topline Data Readout for Our 52-Week Phase 3 Trial Expected Year-End 2024. Internal Investigation by Outside Counsel Has Found No Evidence to Substantiate Allegations of Research Misconduct by the Company. AUSTIN, Texas, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today reported financial and operating results for the full year ended December 31, 2023 and presented corporate updates.

“I see Alzheimer’s disease as one of the last great frontiers in medicine,” said Remi Barbier, President & CEO. “It’s clear to me these patients need new and more simplified treatment options. In 2024 and beyond, we’ll continue to try to make a meaningful difference in the lives of people who suffer from Alzheimer’s disease. I believe our Phase 3 program of simufilam in Alzheimer’s will reach important milestones in 2024, particularly in patients with mild disease.”

Simufilam is Cassava Sciences’ investigational drug candidate for the proposed treatment of Alzheimer's disease dementia.

Net loss for full year 2023 was $97.2 million, or $2.32 per share, compared to a net loss of $76.2 million, or $1.90 per share, in 2022. Net cash used in operations full-year 2023 was $82.0 million, consistent with previous guidance. Cash use for operations for the first half of 2024 is expected to be $35 to $45 million, driven primarily by expenses for our clinical program in Alzheimer’s disease. In 2024, the Company raised gross proceeds of approximately $21.8 million from the exercise of common stock warrants though February 26, 2024.

“We expect our research and development expenses to decrease modestly in 2024 as a result of decreased spending for our Phase 3 program, as patient screening and enrollment are now complete for the Phase 3 clinical studies,” said Eric Schoen, Chief Financial Officer. “We also expect the decrease in Phase 3 program costs to be partially offset by increased enrollment in the open-label study as well as higher expenses in other parts of our operations.”

Financial Results for Full-year 2023

At December 31, 2023, cash and cash equivalents were $121.1 million, compared to $201 million at December 31, 2022, with no debt. In 2024 through February 26, 2024, we received gross proceeds of $21.8 million from the exercise of warrants, resulting in the issuance of 989,000 shares of common stock. (This amount is not included in the above cash and cash equivalents at December 31, 2023.) Net loss was $97.2 million, or $2.32 per share. This compares to a net loss of $76.2 million, or $1.90 per share, in 2022. Net loss increased due primarily to increases in patient enrollment and associated costs to conduct the Phase 3 clinical program, as well as other studies with simufilam. Net cash used in operations full-year 2023 was $82 million. Net cash use in operations for first half 2024 is expected to be $35 to $45 million, driven primarily by expenses for our program in Alzheimer’s disease. Research and development (R&D) expenses were $89.4 million. This compared to $68 million for 2022. R&D expenses increased due primarily to increasing patient enrollment and costs to conduct the Phase 3 clinical program, as well as other studies with simufilam. General and administrative (G&A) expenses were $16.5 million. This compared to $12.0 million for 2022. G&A expenses increased due to increases in stock-based compensation as well as activities and expenses related to legal services.

Recent corporate highlights include the following:

In January 2024, we completed a dividend distribution of common stock warrants to shareholders. The warrants allow the holder to purchase additional shares of our common stock. The warrants trade on Nasdaq (SAVAW), separate from our common stock (SAVA). Unless earlier redeemed, the warrants will expire and cease to be exercisable on November 15, 2024. The warrants are redeemable at our sole option at any time with a redemption date on or after April 15, 2024. Cassava Sciences will provide at least 20 calendar days’ notice by press release of the date selected, if any, for a redemption. In February 2024, we reported that patients with mild Alzheimer’s disease who received simufilam treatment continuously for two years (n=47) had no decline in ADAS-Cog scores (± 1.51 SE) as a group. Patients with mild Alzheimer’s who received simufilam treatment non-continuously for two years (n=40) declined 1 point on ADAS-Cog (± 1.65 SE) as a group. Continuous treatment consisted of one year on open-label drug, six months randomized to drug and six months back on open-label drug. Non

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Cassava Sciences Reports Third Quarter 2023 Financial and Operating Results

Enrollment completed for Phase 3 trials evaluating oral simufilam in Alzheimer's.

Over 1,900 patients randomized in on-going Phase 3 trials. Top-line results for 52-week Phase 3 trial expected approximately year-end 2024; top-line results for 76-week Phase 3 trial expected approximately mid-year 2025. MRI safety data suggests simufilam is not associated with ARIA. $142.4 Million in cash and cash equivalents at September 30, 2023.

AUSTIN, Texas, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today reported financial and operating results for the third quarter ended September 30, 2023.

“In the third quarter, Cassava Sciences made important progress with simufilam, our lead drug candidate,” said Remi Barbier, President & CEO. “This progress exemplifies our unwavering commitment to develop a new treatment option for people with Alzheimer’s.”

Simufilam is Cassava Sciences’ proprietary oral drug candidate. This investigational drug binds to altered filamin A protein in the brain and restores its normal shape and function. By targeting altered filamin A, simufilam may help patients with Alzheimer’s achieve better health outcomes.

Cassava Sciences recently announced the completion of enrollment in a pair of on-going Phase 3 trials to evaluate the safety and efficacy of oral simufilam versus placebo in Alzheimer's disease dementia. A total of 1,929 patients were randomized in these two Phase 3 trials.

The first Phase 3 trial (NCT04994483) has a 52-week treatment period; 804 Alzheimer’s patients were randomized into this study. Top-line results for the 52-week Phase 3 study are currently expected approximately year-end 2024.

The second Phase 3 trial (NCT05026177) has a 76-week treatment period; 1,125 Alzheimer’s patients were randomized into this study. Top-line results for the 76-week Phase 3 study are currently expected approximately mid-year 2025.

Cassava Sciences recently presented interim safety MRI data that suggests simufilam is not associated with treatment-emergent ARIA, which are imaging abnormalities. In addition, in September 2023, a Data and Safety Monitoring Board (DSMB), recommended that the Phase 3 studies continue as planned, without modification. Finally, in September 2023, a fourth academic institution showed non-clinical data in support of the biological activity of simufilam.

Financial Results for Third Quarter 2023

At September 30, 2023, cash and cash equivalents were $142.4 million, with no debt. Net loss was $25.7 million, or $0.61 per share. This compares to a net loss of $20.3 million, or $0.51 per share, for the same period in 2022. Net loss increased due primarily to increases in patient enrollment and associated costs to conduct the Phase 3 clinical program, as well as other studies with simufilam. Net cash used in operations was $59.7 million during the first nine months of 2023. Net cash use in operations for second half 2023 is expected to be $40 to $50 million, consistent with previous guidance and driven primarily by expenses for our clinical program in Alzheimer’s disease. Research and development (R&D) expenses were $23.6 million. This compared to $18.5 million for the same period in 2022. R&D expenses increased due primarily to increasing patient enrollment and costs to conduct the Phase 3 clinical program, as well as other studies with simufilam. General and administrative (G&A) expenses were $4.3 million. This compared to $2.8 million for the same period in 2022. G&A expenses increased due to activities and expenses related to legal services as well as increases in stock-based compensation. About Cassava Sciences, Inc. Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Our novel science is based on stabilizing—but not removing—a critical protein in the brain. Our product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established.

For more information, please visit: https://www.CassavaSciences.com

For More Information Contact:

Eric Schoen, Chief Financial Officer (512) 501-2450 or ESchoen@CassavaSciences.com

Cautionary Note Regarding Forward-Looking Statements:

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that may include but are not limited to: the design, scope, conduct, continuation, completion, intended purpose, or future results of our on-going Phase 3 program of simufilam in patients with Alzheimer's disease; the suitability of clinical data from our Phase 3 program to support the filing of an NDA; any f

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Cassava Sciences Reports Q2 2023 Financial Results and Operating Updates

Results of a randomized, controlled trial of oral simufilam in Alzheimer’s disease announced July 2023.

Over 1,587 patients now enrolled in Phase 3 studies of simufilam in Alzheimer’s disease, an increase of over 340 patients in the last three months. Completion of patient enrollment for Phase 3 program still expected Q4 2023. $168.4 Million in Cash and Cash Equivalents at June 30, 2023. AUSTIN, Texas, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced financial results for the second quarter ended June 30, 2023. Net loss was $26.4 million, or $0.63 per share, compared to a net loss of $19.3 million, or $0.48 per share, for the same period in 2022. Net cash used in operations was $33.2 million during the first half of 2023. Net cash use in second half 2023 is expected to be $40 to $50 million, driven primarily by expenses for our clinical program in Alzheimer’s disease.

“In July 2023, we announced clinical results of a randomized controlled trial with oral simufilam in over 150 patients with Alzheimer’s disease,” said Remi Barbier, President & CEO. “In this study simufilam treatment for 6 months slowed cognitive decline by 38% versus placebo over six-month in patients with mild-to-moderate Alzheimer’s disease. In addition, oral simufilam continues to be safe, well-tolerated. We believe these clinical results are noteworthy.”

Cassava Sciences continues to evaluate its lead oral drug candidate, simufilam, in Alzheimer’s disease. Over 1,587 patients with mild-to-moderate Alzheimer’s disease are now enrolled in a Phase 3 program of simufilam, an increase of over 340 patients in the last three months. The target enrollment is approximately 1,750 patients. Cassava Sciences expects to complete patient enrollment for its Phase 3 program in Q4 2023.

Financial Results for Second Quarter 2023

At June 30, 2023, cash and cash equivalents were $168.4 million, with no debt. Net loss was $26.4 million, or $0.63 per share. This compares to a net loss of $19.3 million, or $0.48 per share, for the same period in 2022. Net loss increased due primarily to increases in the rate of patient enrollment and associated costs to conduct the Phase 3 clinical program, as well as other studies with simufilam. Net cash used in operations was $33.2 million during the first six months of 2023. Net cash use in operations for second half 2023 is expected to be $40 to $50 million, driven primarily by expenses for our clinical program in Alzheimer’s disease. Research and development (R&D) expenses were $25.0 million. This compared to $16.9 million for the same period in 2022. R&D expenses increased due primarily to increasing patient enrollment and costs to conduct the Phase 3 clinical program, as well as other studies with simufilam. General and administrative (G&A) expenses were $3.8 million. This compared to $3.0 million for the same period in 2022. G&A expenses increased due primarily to increases in stock-based compensation and activities and expenses related to legal services. On-going Phase 3 Studies with Simufilam Cassava Sciences is currently evaluating oral simufilam for Alzheimer’s disease dementia in two Phase 3 clinical studies. These are large, randomized, double-blind, placebo-controlled trials. The Phase 3 program is recruiting a total of approximately 1,750 patients with mild-to-moderate Alzheimer’s disease who also meet other study eligibility criteria. Both Phase 3 studies have received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration. Our Phase 3 studies recruit Alzheimer’s patients in clinical sites in the United States, Canada, Puerto Rico, South Korea and Australia.

About Simufilam Simufilam is Cassava Sciences’ proprietary, small molecule (oral) drug candidate that restores the normal shape and function of altered filamin A (FLNA) protein in the brain. Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party.

About Cassava Sciences, Inc. Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Our novel science is based on stabilizing—but not removing—a critical protein in the brain. Our product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established.

For more information, please visit: https://www.CassavaSciences.com

For More Information Contact:

Eric Schoen, Chief Financial Officer (512) 501-2450 or ESchoen@CassavaSciences.com

Cautionary Note Regarding Forward-Looking Statements:

This news release conta

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EXHIBIT 99.1

Cassava Sciences Reports Q1 2023 Financial Results and Operating Updates

Over 1,244 Alzheimer’s patients now enrolled in Phase 3 studies of simufilam. Completion of patient enrollment for Phase 3 program still expected Q4 2023. $187.5 Million Cash and Cash Equivalents at March 31, 2023.

AUSTIN, Texas, May 01, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced financial results for the first quarter ended March 31, 2023. Net loss was $24.3 million, or $0.58 per share, compared to a net loss of $17.5 million, or $0.44 per share, for the same period in 2022. Net cash used in operations was $13.3 million during the first quarter of 2023. New guidance for net cash use in first half 2023 is expected to be $30 to $40 million, which is revised downward from our previous guidance of $45 to $50 million, due primarily to the timing of certain clinical payment obligations.

Cassava Sciences is evaluating its lead drug candidate, simufilam, in people with Alzheimer’s disease. Over 1,244 patients with mild-to-moderate Alzheimer’s disease are now enrolled in our Phase 3 program of simufilam, up from over 1,000 enrolled patients as of February 28, 2023. The target enrollment is approximately 1,750 patients.

“In Q1 2023, we announced results of a one-year, open-label Phase 2 safety study of simufilam in over 200 patients with Alzheimer’s disease,” said Remi Barbier, President & CEO. “The dataset for this study shows long-term safety for simufilam. Notably, the data also show differences in changes in ADAS-Cog scores in mild and moderate subgroups. We believe this is an encouraging result, as it clearly shows an improvement in ADAS-Cog over 1 year in mild patients taking simufilam that is well outside the expected range of historical placebo decline from numerous other studies.”

Mr. Barbier continued, “Looking forward, our top priority is to complete patient enrollment for our Phase 3 program. We also look forward to announcing science updates, including completion of patient dosing for our Cognition Maintenance Study. In this randomized, placebo-controlled study, over 100 patients with mild-to-moderate Alzheimer’s who completed at least one year of open-label treatment with simufilam are subsequently randomized to placebo or simufilam for six months. This is known as a randomized, withdrawal study design. While complex, I think this study design may yield interesting clinical data in Q3. Separately, in Q2 we expect to announce new evidential data for the biological activity of simufilam on filamin A protein.”

Financial Results for First Quarter 2023

At March 31, 2023, cash and cash equivalents were $187.5 million, with no debt. Net loss was $24.3 million, or $0.58 per share. This compares to a net loss of $17.5 million, or $0.44 per share, for the same period in 2022. Net loss increased due primarily to increases in the rate of patient enrollment and associated costs to conduct the Phase 3 clinical program, as well as other studies with simufilam. Net cash used in operations was $13.3 million during the first quarter of 2023. Net cash use in operations for the first half 2023 is now expected to be $30 to $40 million, compared to previous guidance of $45 to $50 million due primarily to the timing of certain payment obligations for studies of simufilam. Research and development (R&D) expenses were $22.1 million. This compared to $14.9 million for the same period in 2022. R&D expenses increased due primarily to increasing patient enrollment and costs to conduct the Phase 3 clinical program, as well as other studies with simufilam. General and administrative (G&A) expenses were $4.4 million. This compared to $2.9 million for the same period in 2022. G&A expenses increased due primarily to increased activities and expenses related to legal services. About Cassava Sciences’ Phase 3 Program We are conducting a Phase 3 clinical evaluation of simufilam in people with Alzheimer’s disease dementia. This program consists of two on-going, randomized, double-blind, placebo-controlled studies. Both Phase 3 studies have received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration. The Phase 3 program is recruiting a total of approximately 1,750 patients with mild-to-moderate Alzheimer’s disease who also meet other study eligibility criteria. Our Phase 3 studies are actively recruiting Alzheimer's patients in over 100 clinical sites in the United States, Canada, Puerto Rico, South Korea and Australia. For detailed information about Cassava Sciences’ Phase 3 program, please visit the website for ClinicalTrials.gov: https://ClinicalTrials.gov/ct2/show/NCT04994483?term=simufilam&draw=2&rank=3

About Simufilam Simufilam is a novel drug candidate designed to treat and slow the progression of Alzheimer’s disease. Simufilam binds tightly to an altered c

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EXHIBIT 99.1

Cassava Sciences Reports Full-year 2022 Financial Results and Operating Updates

In Q2 2023, We Expect to Complete Patient Dosing for our Cognition Maintenance Study in Alzheimer’s disease. In Q3 2023, We Expect to Announce Results of our Cognition Maintenance Study. In Q4 2023, We Expect to Complete Patient Enrollment for our Phase 3 Studies of Simufilam in Alzheimer’s disease. Mid-year 2023, We Expect an Independent Third Party to Present Evidential Data for The Biological Activity of Simufilam Outside of Neurodegeneration. Cash And Cash Equivalents Were $201 Million at December 31, 2022.

AUSTIN, Texas, Feb. 28, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced financial results for the year ended December 31, 2022, and provided operating updates. Simufilam is Cassava Sciences’ oral drug candidate for the proposed treatment of Alzheimer’s disease dementia.

“Setting aside headwinds, 2022 was highlighted by positive developments with patient enrollment in our Phase 3 clinical studies of simufilam in Alzheimer’s disease”, said Remi Barbier, President & CEO. “Over 1,000 patients with Alzheimer’s are now enrolled in these two studies. By year-end 2023, we expect to reach our enrollment target of approximately 1,750 patients for the Phase 3 studies. Recently, we announced top-line results for an open-label study. In this study, over 200 mild-to-moderate Alzheimer’s patients were treated with simufilam for a year. Simufilam was well-tolerated, 47% of patients improved on ADAS-Cog scores over 12 months and an additional 23% of patients declined less than 5 points on ADAS-Cog. I believe these are noteworthy trial results, even as I am keenly aware that the gold standard in Alzheimer’s research requires results from randomized, controlled studies.”

Alzheimer’s disease is a major public health issue. It imposes an immense burden on patients, their families and caregivers. Anti-amyloid antibody drugs that have received FDA approval are a step in the right direction. But by themselves, anti-amyloid drugs may not be enough for patients. Anti-amyloid drugs can slow cognitive decline modestly, but they can also cause brain bleeds in elderly patients, they require monthly trips to the local infusion center and periodical monitoring with MRI, they’re expensive and they lack Medicare coverage because they bypassed the full FDA approval process. Patients have waited many years for anti-amyloid drugs to be FDA-approved. Now that the wait is over, Cassava Sciences sees an even greater need to develop the next generation of innovative treatments, even if some of these potential treatments challenge scientific orthodoxy.

“It’s the spirit of innovation and our intense desire to help patients and their families that fuels our drive to develop simufilam as an oral drug candidate for people with Alzheimer’s disease,” said Remi Barbier.

Cassava Sciences’ Scientific Goals for 2023

In Q2 2023, we expect to complete patient dosing for our on-going Cognition Maintenance Study, in which over 100 patients with mild-to-moderate Alzheimer’s disease are randomized (1:1) to simufilam or placebo for six months. In Q3 2023, we expect to announce top-line results of the Cognition Maintenance Study. In Q4 2023, we expect to complete patient enrollment for both of our Phase 3 studies. Mid-year 2023, we expect an independent, third party to present evidential data for the biological activity of simufilam outside the field of neurodegeneration. Mid-year 2023, we expect an independent, third party to generate new data for SavaDx using mass spectrometry.

Financial Highlights

At December 31, 2022, cash and cash equivalents were $201 million, compared to $233.4 million at December 31, 2021, with no debt. Year-end cash balance included net proceeds of $47.3 million from the sale of 1.7 million shares of common stock completed in November 2022. Net cash used in operations full-year 2022 was $77.5 million, net of reimbursements received from National Institutes of Health (NIH) grant awards. Net cash use for operations for the first half of 2023 is expected to be approximately $45 to $50 million, driven primarily by expenses for our clinical program in Alzheimer’s disease. Research and development (R&D) expenses for the year ended December 31, 2022 were $68.0 million compared to $24.8 million for the same period in 2021. This increase was due primarily to costs to conduct the ongoing Phase 3 clinical program in simufilam, costs of an ongoing cognition maintenance study and open-label study in simufilam, and costs related to manufacture of clinical trial supplies, as well as increased pre-clinical study and personnel expenses compared to the prior year. These expenses are net of grant funding received from NIH, which is recorded as a reduction in R&D expenses. Research grant funding reimb

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EXHIBIT 99.1

Cassava Sciences Reports Third Quarter Financial Results for 2022 and Business Updates

– $174.7 Million Cash and Cash Equivalents at September 30, 2022 –

– Over 650 Patients Now Enrolled in Phase 3 Program -

– New Clinical Data for Simufilam in Alzheimer’s Disease Expected –

AUSTIN, Texas, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced financial results for the third quarter ended September 30, 2022 and provided a clinical update on its Phase 3 clinical program of simufilam in Alzheimer’s disease. Simufilam is Cassava Sciences’ lead drug candidate for the proposed treatment of Alzheimer’s disease.

“The clinical development of oral simufilam for Alzheimer’s disease continues to make headway,” said Remi Barbier, President & CEO. “We now have over 650 patients enrolled in our on-going Phase 3 studies of simufilam in Alzheimer's disease, up from 150 patients approximately six months ago. We also look forward to presenting new clinical data for simufilam from two other ongoing studies in Alzheimer’s disease.”

Net loss for third quarter 2022 was $20.3 million, or $0.51 per share, compared to a net loss of $9.6 million, or $0.24 per share, for the same period in 2021. Net cash used in operations was $56.2 million during the first nine months of 2022. Net cash use for operations for full-year 2022 is expected to be approximately $80 to $90 million, consistent with previous guidance. Cash and cash equivalents were $174.7 million as of September 30, 2022, with no debt.

Financial Results for Third Quarter 2022

At September 30, 2022, cash and cash equivalents were $174.7 million, with no debt. Net loss was $20.3 million, or $0.51 per share. This compares to a net loss of $9.6 million, or $0.24 per share, for the same period in 2021. Net loss increased compared to the prior period due primarily to a significant increase in our R&D activities for a Phase 3 program of simufilam in Alzheimer’s disease. Net cash used in operations was $56.2 million during the first nine months of 2022. Net cash use in operations for full year 2022 is expected to be approximately $80 to $90 million, consistent with previous guidance. Research and development (R&D) expenses were $18.5 million. This compared to $8.0 million for the same period in 2021. R&D expenses increased compared to the prior period due primarily to increased activities and expenses related to clinical and pre-clinical studies and support functions. General and administrative (G&A) expenses were $2.8 million. This compared to $1.7 million for the same period in 2021. G&A expenses increased compared to the prior period due primarily to increased activities and expenses related to legal services as well as depreciation and amortization. Overview of On-going Phase 3 Clinical Program Cassava Sciences’ Phase 3 program consists of two randomized controlled trials of oral simufilam in patients with mild-to-moderate Alzheimer’s disease. The two studies are named RETHINK-ALZ and REFOCUS-ALZ. In 2021, both studies received Special Protocol Assessments (SPA) from the U.S. Food and Drug Administration.

Over 650 patients are now enrolled in our Phase 3 studies. Studies are being conducted in over 100 clinical trial sites across the U.S., Canada, Puerto Rico, South Korea and Australia.

Cassava Sciences’ RETHINK-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing functional decline over 52 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100 mg or matching placebo twice daily.

Cassava Sciences’ REFOCUS-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 76 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 1,000 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1:1) to simufilam 100 mg, 50 mg, or matching placebo twice daily.

Both of Cassava Sciences’ Phase 3 studies have the same co-primary efficacy endpoints: ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a functional scale). A secondary efficacy endpoint is iADRS, a clinical tool that combines cognitive and functional scores from ADAS-Cog & ADCS-ADL.

Open-label Study – closed enrollment

In March 2020, we initiated a long-term, open-label study to evaluate simufilam, our lead drug candidate, in patients with mild-to-moderate Alzheimer’s disease. The study is intended to monitor the long-term safety and tolerability of simufilam 100 mg twice daily for 12 or more months. The open-label study has reached its final target enrollment of approximately 200 patients with Alzheimer’s disease. We expect to announce open-lab

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EXHIBIT 99.1

Cassava Sciences Reports Second Quarter Financial Results for 2022, Mid-year Corporate Update and Interim Analysis of Open-label Study

Phase 3 Program - Over 400 Patients Are Now Enrolled in Our Phase 3 Clinical Studies. Open-label Study – Results of an Interim Analysis on the First 100 Patients Who Have Completed at Least 12 Months of Open-label Treatment with Simufilam Follow: Drug Appears Safe and Well Tolerated. Overall ADAS-Cog11 Scores Improved an Average of 1.5 Points (S.D. ± 6.6; P<0.05) 63% of the 100 Patients Showed an Improvement in ADAS-Cog11 Scores, and This Group of Patients Improved an Average of 5.6 Points (S.D. ± 3.8). An Additional 21% of the 100 Patients Declined Less Than 5 Points on ADAS-Cog11, and This Group of Patients Declined an Average of 2.7 Points (S.D. ± 1.4). Cognition Maintenance Study - Completion of Patient Enrollment is Expected Q4 2022. Financial Results - Net Loss for Q2 2022 Was $19.3 Million, or $0.48 Per Share. Cash Position - $197.2 Million of Cash and Cash Equivalents at June 30, 2022.

AUSTIN, Texas, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced financial results for the second quarter ended June 30, 2022, a mid-year corporate update, and interim clinical results of an open-label study with simufilam. Simufilam is Cassava Sciences’ lead drug candidate for the proposed treatment of Alzheimer’s disease. SavaDx is Cassava Sciences’ investigational diagnostic candidate to detect Alzheimer’s disease from a simple blood draw.

“I’m pleased with our operating performance in the first half of 2022,” said Remi Barbier, President & CEO. “I’m also humbled by the hard work of our team members and clinical partners. Persistence and a focus on performance are key when you’re trying to beat Alzheimer’s disease.”

Update on Patient Enrollment for Phase 3 Program A total of over 400 patients are now enrolled in our on-going Phase 3 program of simufilam in Alzheimer’s disease. Enrollment is almost evenly split between the two Phase 3 studies.

Overview of Phase 3 Program with Simufilam in Alzheimer's Disease Our Phase 3 program consists of two double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease. Both Phase 3 studies have Special Protocol Assessments (SPA) from the U.S. Food and Drug Administration. Both studies have the same co-primary efficacy endpoints: ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a functional scale). A secondary efficacy endpoint for both studies is iADRS, a clinical tool that combines cognitive and functional scores from ADAS-Cog & ADCS-ADL. Patients are now being screened in clinical trial sites in the U.S., Canada, Puerto Rico and Australia.

RETHINK-ALZ is the trade name of our 52-week Phase 3 study. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety & efficacy of oral simufilam 100 mg or placebo, twice daily, over 52 weeks in approximately 750 patients with Alzheimer’s disease.

REFOCUS-ALZ is the trade name of our 76-week Phase 3 study. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety & efficacy of oral simufilam 100 mg, 50 mg or placebo, twice daily, over 76 weeks in approximately 1,000 patients with Alzheimer’s.

Future Open-label Extension Study for the Phase 3 Program

In the second half of 2022, we expect to initiate an open-label extension study for our Phase 3 program. This new study is designed to provide no-cost access to simufilam to patients with Alzheimer’s disease who have successfully completed a Phase 3 study of simufilam.

On-going Open-label Study with Simufilam in Alzheimer's Disease

In March 2020, we initiated a long-term, open-label study to evaluate simufilam in patients with mild-to-moderate Alzheimer’s disease. The study is intended to monitor the long-term safety and tolerability of simufilam 100 mg twice daily over 12 months or more. This study has reached its target enrollment of approximately 200 patients. We expect all patients for this study will complete drug treatment in Q4 2022. We expect to announce top-line clinical results for this study approximately year-end 2022.

On-going Open-label Study - Interim Analysis on 100 Subjects at 12 Months

An interim analysis was conducted on the first 100 evaluable patients who completed at least 12 months of open-label treatment with simufilam 100 mg twice daily. Top-line results of this interim analysis show that from baseline to month-12:

Drug appears safe and well tolerated. Overall ADAS-Cog11 scores improved an average of 1.5 points (S.D. ± 6.6; P<0.05) 63% of the 100 patients showed an improvement in ADAS-Cog11 scores, and this group of patients improved an average of 5.6 points (S.D. ± 3.8). An additional 21% of the 100 patients declined less than 5 points on

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EXHIBIT 99.1

Cassava Sciences Reports First Quarter Financial Results for 2022 and Updates on Phase 3 Clinical Program

- $209.7 Million Cash and Cash Equivalents at March 31, 2022 –

- Over 120 Patients Now Enrolled in Phase 3 Program -

AUSTIN, Texas, May 05, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced financial results for the first quarter ended March 31, 2022 and provided a clinical update on its Phase 3 clinical program of simufilam in Alzheimer’s disease. Simufilam is Cassava Sciences’ lead drug candidate for the proposed treatment of Alzheimer’s disease.

Net loss was $17.5 million, or $0.44 per share, compared to a net loss of $3.5 million, or $0.09 per share, for the same period in 2021. Net cash used in operations was $23.5 million during the first quarter of 2022, including over $10 million of contractual pre-payments. Pre-payments are amounts paid for in advance of future research and development (R&D) services.

“We’re seeing an uptick in the rate of patient enrollment,” said Remi Barbier, President & CEO. “In part, the pandemic challenged some clinical sites, from staffing shortages to operational gaps. We hope these challenges are in the rearview mirror as we continue to move forward with our Phase 3 studies of simufilam in Alzheimer’s disease, while keeping an eye on the balance sheet.”

Financial Results for First Quarter 2022

At March 31, 2022, cash and cash equivalents were $209.7 million, with no debt.

Net loss was $17.5 million, or $0.44 per share. This compares to a net loss of $3.5 million, or $0.09 per share, for the same period in 2021. Net loss increased compared to the prior period due primarily to a significant increase in our R&D activities and G&A expenses.

Net cash used in operations was $23.5 million during the first quarter of 2022.

Net cash use in operations for the first half 2022 is now expected to be approximately $35 to $40 million, including significant (over $10 million) contractual pre-payments made to R&D vendors for future services, such as our contract research organization for the Phase 3 clinical program of simufilam in Alzheimer’s disease.

Research and development (R&D) expenses were $14.9 million. This compared to $2.5 million for the same period in 2021. R&D expenses increased compared to the prior period due primarily to increased activities and expenses related to clinical studies, clinical trial supplies and support functions and personnel expenses.

General and administrative (G&A) expenses were $2.9 million. This compared to $1.0 million for the same period in 2021. G&A expenses increased compared to the prior period due primarily to increased activities and expenses related to legal services and depreciation and amortization.

Overview of On-going Phase 3 Clinical Program

Our Phase 3 program consists of two double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease. Both Phase 3 studies have Special Protocol Assessments (SPA) from the U.S. Food and Drug Administration.

A total of over 120 subjects have now been enrolled in our Phase 3 studies. Studies are being conducted in over 115 clinical trial sites across the U.S., Canada and Puerto Rico.

Overview of Each On-going Phase 3 Study - RETHINK-ALZ and REFOCUS-ALZ

Our Phase 3 study called “RETHINK-ALZ” is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing functional decline over 52 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer’s disease.

Details of the RETHINK-ALZ Phase 3 study include:

Subjects are randomized (1:1) to simufilam 100 mg or placebo twice daily. The co-primary efficacy endpoints are ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a functional scale). A secondary efficacy endpoint is iADRS, a clinical tool that combines cognitive and functional scores from ADAS-Cog & ADCS-ADL. Our Phase 3 study called “REFOCUS-ALZ” is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 76 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 1,000 patients with mild-to-moderate Alzheimer’s disease.

Details of the REFOCUS-ALZ Phase 3 study, include:

Subjects are randomized (1:1:1) to simufilam 100 mg, 50 mg, or placebo twice daily. The co-primary efficacy endpoints are ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a functional scale). A secondary efficacy endpoint is iADRS, a clinical tool that combines cognitive and functional scores from ADAS-Cog & ADCS-ADL. Open-label Study – closed enrollment

In March 2020, we initiated a long-term, open-label study to evaluate simufilam, our lead drug candidate, in patients with mild-to-moderate Alzheimer’s disease. The study is inte