CASSAVA SCIENCES INC

Previous wording

Cassava Sciences, Inc. is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat central nervous system disorders, such as Tuberous Sclerosis Complex (“TSC”)-related epilepsy. Our novel science is based on affecting the activity of a critical protein in the brain for patients with certain central nervous system disorders, such as TSC. Our lead therapeutic drug candidate, simufilam, was under clinical evaluation for the proposed treatment of Alzheimer’s disease in two Phase 3 clinical studies through 2024, when all ongoing clinical trials for simufilam in Alzheimer’s disease were discontinued. On March 25, 2025, we announced the decision to phase out the Company’s Alzheimer's disease development program, which we expect to be completed by the end of the second quarter of 2025.

Current wording

Cassava Sciences, Inc. is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat central nervous system disorders, such as Tuberous Sclerosis Complex (“TSC”)-related epilepsy. Our novel science is based on affecting the activity of a critical protein in the brain for patients with certain central nervous system disorders, such as TSC. Our lead therapeutic drug candidate, simufilam, was under clinical evaluation for the proposed treatment of Alzheimer’s disease in two Phase 3 clinical studies through 2024, when all ongoing clinical trials for simufilam in Alzheimer’s disease were discontinued. The phase out of the Company’s Alzheimer's disease development program was completed in the second quarter of 2025.

Previous wording

We intend to conduct exploratory preclinical studies in collaboration with the TSCA and other researchers to better understand simufilam’s potential as a treatment for TSC-related seizures. Based on the results of these studies, considered together with Dr. Bordey’s work, the Company will assess whether sufficient support exists for an Investigational New Drug (“IND”) application in respect of a proof-of-concept clinical trial for simufilam in TSC-related epilepsy. Dr. Bordey joined the Company as Senior Vice President, Neuroscience, on May 1, 2025, while continuing her tenured academic position at Yale School of Medicine on a part time basis.

Current wording

Dr. Bordey joined the Company as Senior Vice President, Neuroscience, on May 1, 2025, while continuing her tenured academic position at Yale School of Medicine on a part time basis.

Previous wording

Following the release of the topline RETHINK-ALZ and REFOCUS-ALZ results, the Company announced the decision to phase out the Company's Alzheimer's disease development program, which we expect to be completed by the end of the second quarter of 2025.

Current wording

Following the release of the topline RETHINK-ALZ and REFOCUS-ALZ results, the Company announced the decision to phase out the Company's Alzheimer's disease development program, which was completed in the second quarter of 2025.

Previous wording

On April 15, 2025, James W. Kupiec, M.D. informed the Company of his intent to retire and tendered his resignation as the Company’s Chief Medical Officer, effective as of May 9, 2025.

Current wording

As previously announced, James W. Kupiec, M.D., retired as the Company’s Chief Medical Officer, with his resignation effective as of May 9, 2025.

Previous wording

We intend to conduct exploratory preclinical studies in collaboration with the TSCA and other researchers to better understand simufilam’s potential as a treatment for TSC-related seizures. Based on the results of such additional studies, considered together with pre-clinical academic research, the Company will assess whether there is support for an IND application in respect of a proof-of-concept clinical trial for simufilam in TSC-related epilepsy.

Current wording

We intend to continue exploratory preclinical studies in collaboration with the TSCA and other researchers to better understand simufilam’s potential as a treatment for TSC-related seizures. The Company also intends to submit an IND application in respect of a proof-of-concept clinical trial for simufilam in TSC-related epilepsy.

Previous wording

The Company announced top-line results for REFOCUS-ALZ on March 25, 2025 as well as the decision to phase out the Company's Alzheimer's disease development program, which is expected to be completed by the end of the second quarter of 2025.

Current wording

The Company announced top-line results for REFOCUS-ALZ on March 25, 2025 as well as the decision to phase out the Company's Alzheimer's disease development program, which was completed in the second quarter of 2025.

Previous wording

Our investigational product candidate, called SavaDx, is an early-stage program focused on detecting the presence of Alzheimer’s disease from a small sample of blood. For business, technical and personnel reasons, we continue to prioritize the development of simufilam, our novel drug candidate, over SavaDx, our novel diagnostic candidate. SavaDx is a research-use only, non-safety related exploratory biomarker. Development activity related to SavaDx accounts for less than 1% of our research budget.

Current wording

Our investigational product candidate, called SavaDx, is an early-stage program focused on detecting the presence of Alzheimer’s disease from a small sample of blood. For business, technical and personnel reasons, we have discontinued the development of SavaDx as of mid-2025. SavaDx is a research-use only, non-safety related exploratory biomarker. Development activity related to SavaDx accounted for less than 1% of our research budget.

Previous wording

Simufilam was discovered and designed in-house and was characterized by our academic collaborators during research activities that were conducted from approximately 2008 to date. SavaDx is being developed in-house with outside collaborators. We solely own patents covering the composition of matter of our drug simufilam in the United States, Europe, Australia, Israel and Canada. We solely own patents covering certain methods of use of our drug simufilam in the United States, Europe and Japan. We solely own pending patent applications that cover diagnostic assets for simufilam in the United States, Europe, Japan, China, Canada, and Australia. We solely own pending patent applications that cover other diagnostic assets in the United States, Europe, Japan, China and Canada. We have no obligation to pay any royalty to any third party in connection with any of the foregoing described patents and patent applications. In the United States, our patent protection with respect to simufilam, its solid forms, and uses of simufilam for Alzheimer’s disease and other neurodegenerative diseases includes nine issued United States patents, with terms expiring on dates ranging from 2029 to 2040, subject to any patent extensions that may be available for such patents. Corresponding foreign filings have been made for each of the United States filings. We may also pursue additional intellectual property protections in other jurisdictions or in connection with any potential expansion into other indications, including other central nervous system disorders, such as TSC-related epilepsy, in each case, in light of the Company’s overall strategic development plans.

Current wording

Simufilam was discovered and designed in-house and was characterized by our academic collaborators during research activities that were conducted from approximately 2008 to date. We solely own patents covering the composition of matter of our drug simufilam in the United States, Europe, Australia, Israel and Canada. We solely own patents covering certain methods of use of our drug simufilam in the United States, Europe and Japan. We solely own pending patent applications that cover diagnostic assets for simufilam in the United States, Europe, Japan, China, Canada, and Australia. We solely own pending patent applications that cover other diagnostic assets in the United States, Europe, Japan, China and Canada. We have no obligation to pay any royalty to any third party in connection with any of the foregoing described patents and patent applications. In the United States, our patent protection with respect to simufilam, its solid forms, and uses of simufilam for Alzheimer’s disease and other neurodegenerative diseases includes nine issued United States patents, with terms expiring on dates ranging from 2029 to 2040, subject to any patent extensions that may be available for such patents. Corresponding foreign filings have been made for each of the United States filings. We may also pursue additional intellectual property protections in other jurisdictions or in connection with any potential expansion into other indications, including other central nervous system disorders, such as TSC-related epilepsy, in each case, in light of the Company’s overall strategic development plans.

Previous wording

We have yet to generate any revenues from product sales. We have an accumulated deficit of $428.5 million at March 31, 2025. These losses have resulted principally from costs incurred in connection with research and development activities, salaries and other personnel-related costs and general corporate expenses. Research and development activities include costs of clinical and preclinical trials as well as clinical supplies associated with our product candidates. Salaries and other personnel-related costs include stock-based compensation associated with stock options and other equity awards granted to employees and non-employees. Our operating results may fluctuate substantially from period to period as a result of enrollment rates of clinical trials for our product candidates, timing of preclinical activities and our need for clinical supplies.

Current wording

We have yet to generate any revenues from product sales. We have an accumulated deficit of $472.7 million at June 30, 2025. These losses have resulted principally from costs incurred in connection with research and development activities, salaries and other personnel-related costs, legal related costs and general corporate expenses. Research and development activities include costs of clinical and preclinical trials as well as clinical supplies associated with our product candidates. Salaries and other personnel-related costs include stock-based compensation associated with stock options and other equity awards granted to employees and non-employees. Our operating results may fluctuate substantially from period to period as a result of enrollment rates of clinical trials for our product candidates, timing of preclinical activities and our need for clinical supplies.

Previous wording

Estimating the dates of completion of clinical development, and the costs to complete development, of our product candidates would be highly speculative and subjective. Pharmaceutical products take a significant amount of time to research, develop and commercialize. The clinical study portion of the development of a new drug alone usually spans several years. We expect our research and development expenses to decrease in 2025 compared to 2024 as a result of discontinuation of our program in Alzheimer's disease. The decrease is expected to be partially offset by costs to explore an indication for TSC-related epilepsy as well as higher stock-based compensation expense. We expect to reassess our future research and development plans based on our review of data we receive from our current research and development activities. The cost and pace of our future research and development activities are linked and subject to change.

Current wording

Estimating the dates of completion of clinical development, and the costs to complete development, of our product candidates would be highly speculative and subjective. Pharmaceutical products take a significant amount of time to research, develop and commercialize. The clinical study portion of the development of a new drug alone usually spans several years. We expect our research and development expenses to decrease in 2025 compared to 2024 as a result of phase out of our Alzheimer's disease development program, which was completed in the second quarter of 2025. The decrease is expected to be partially offset by costs to explore an indication for TSC-related epilepsy as well as higher stock-based compensation expense. We expect to reassess our future research and development plans based on our review of data we receive from our current research and development activities. The cost and pace of our future research and development activities are linked and subject to change.

Previous wording

There have been no material changes to our critical accounting estimates during the three months ended March 31, 2025 from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 3, 2025.

Current wording

There have been no material changes to our critical accounting estimates during the six months ended June 30, 2025 from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 3, 2025.

Previous wording

Results of Operations–** Three Months Ended March 31, 2025 and 2024**

Current wording

Results of Operations–** Three and Six Months Ended June 30, 2025 and 2024**

Previous wording

Research and development expenses were $13.7 million and $16.2 million during the three months ended March 31, 2025 and 2024, respectively. 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 a $1.4 million increase in stock-based compensation expense due to new awards granted in the third quarter of 2024.

Current wording

Research and development expenses were $18.8 million and $31.4 million during the six months ended June 30, 2025 and 2024, respectively. This 40% decrease was due primarily to the phase out of the Alzheimer's disease development program beginning the fourth quarter of 2024 and completed in the second quarter of 2025. This decrease was partially offset by a $1.6 million increase in stock-based compensation expense due to new awards granted in the third quarter of 2024.

Previous wording

We expect general and administrative expense for 2025 will remain at high historic levels due to professional fees and costs related to ongoing litigation. In addition, stock-based compensation expense will be significantly higher than historic levels due to new awards granted in 2023 and 2024.

Current wording

We expect general and administrative expense will decrease significantly in future quarters. However, we expect general and administrative expense to remain high compared to historic levels due to professional fees, legal expense and potential settlements related to ongoing litigation. In addition, stock-based compensation expense is expected to be higher than historic levels due to new awards granted in 2024 and 2025.

Previous wording

Interest income was $1.3 million and $1.8 million during the three months ended March 31, 2025 and 2024, respectively. The decrease in interest income was due primarily to lower interest rates in 2025 compared to 2024.

Current wording

Interest income was $1.2 million and $2.3 million during the three months ended June 30, 2025 and 2024, respectively. The decrease in interest income was due primarily to lower interest rates and cash balances in 2025 compared to 2024.

Previous wording

There were no common stock warrants outstanding or change in fair value of warrants for the three months ended March 31, 2025. The change in fair value of warrants was $43.0 million for the three months ended March 31, 2024.

Current wording

There were no common stock warrants outstanding or change in fair value of warrants for the three months ended June 30, 2025. The change in fair value of warrants was $65.1 million for the three months ended June 30, 2024.

Previous wording

The 2024 change was attributable to a gain on the change in fair value of our liability-classified warrants from distribution on January 3, 2024 to March 31, 2024. The change in fair value was primarily driven by a decrease in the closing price for the common stock warrants in open-market trading on March 31, 2024 from the fair value determined by the Monte Carlo simulation at distribution.

Current wording

The 2024 change was attributable to a gain on the change in fair value of our liability-classified warrants from distribution on January 3, 2024 to their redemption in May 2024. The change in fair value was primarily driven by a decrease in fair value at redemption as there was little or no market trading activity and the warrants were redeemed for a nominal payment of $0.001 per warrant.

Previous wording

We record the activities related to leasing office space to third parties in buildings we own as other income, net, as leasing is not core to the Company’s operations. Other income (loss), net, was $(0.1) million and $0.2 million during the three months ended March 31, 2025 and 2024, respectively. We recorded other loss in the three months ended March 31, 2025 as due to higher vacancy rates in 2025 compared to the prior year period. We expect other loss to increase in future periods as higher vacancy rates are expected to further lower rental income.

Current wording

We record the activities related to leasing office space to third parties in buildings we own as other income, net, as leasing is not core to the Company’s operations. Other income (loss), net, was $(46,000) and $0.1 million during the three months ended June 30, 2025 and 2024, respectively.

Previous wording

Since inception, we have financed our operations primarily through public and private stock offerings, payments received under collaboration agreements and interest earned on our cash and cash equivalents balances. We intend to continue to use our capital resources to fund research and development activities, capital expenditures, working capital requirements and other general corporate purposes. As of March 31, 2025, cash and cash equivalents were $117.3 million.

Current wording

Since inception, we have financed our operations primarily through public and private stock offerings, payments received under collaboration agreements and interest earned on our cash and cash equivalents balances. We intend to continue to use our capital resources to fund research and development activities, capital expenditures, working capital requirements and other general corporate purposes. As of June 30, 2025, cash and cash equivalents were $112.4 million.

Previous wording

Net cash used in operating activities was $11.3 million for the three months ended March 31, 2025, resulting primarily from a net loss of $23.4 million. This change was partially offset by an increase in accrued development expense of $1.6 million and a decrease in prepaid and other current assets of $5.1 million, and non-cash adjustment for stock-based compensation expense of $5.2 million.

Current wording

Net cash used in operating activities was $16.3 million for the six months ended June 30, 2025, resulting primarily from a net loss of $67.6 million. This change was partially offset by an increase in accrued development expense of $1.3 million, an increase in accounts payable and accrued expenses of $35.2 million and a decrease in prepaid and other current assets of $5.5 million. There was also a non-cash adjustment for stock-based compensation expense of $9.8 million.

Previous wording

Net cash used in operating activities was $19.1 million for the three months ended March 31, 2024, resulting primarily from the net income of $25.0 million and stock-based compensation expense of $2.3 million, offset by a change in fair value of warrants of $43.0 million, an decrease in accounts payable and accrued expenses of $1.0 million, an decrease in accrued developmental expenses of $1.2 million and a decrease in in prepaid and other current assets of $1.3 million.

Current wording

Net cash used in operating activities was $37.4 million for the six months ended June 30, 2024, resulting primarily from the net income of $31.2 million, stock-based compensation expense of $4.9 million and an increase in accounts payable and accrued expenses of $42.0 million, offset by a change in fair value of warrants of $108.2 million, an decrease in accrued developmental expenses of $1.4 million and a decrease in in prepaid and other current assets of $6.3 million.

Previous wording

There was no net cash used in investing activities during the three months ended March 31, 2025 and 2024.

Current wording

There was no net cash used in investing activities during the six months ended June 30, 2025.

Previous wording

Net cash provided by financing activities during the three months ended March 31, 2025 was $0.1 million of proceeds from the exercise of stock options.

Current wording

Net cash provided by financing activities during the six months ended June 30, 2025 was $0.1 million of proceeds from the exercise of stock options.

Previous wording

Net cash provided by financing activities during the three months ended March 31, 2024 was $22.2 million of net proceeds from the exercise of warrants.

Current wording

Net cash provided by financing activities during the six months ended June 30, 2024 was $123.6 million of net proceeds from the exercise of warrants.

Previous wording

We have an accumulated deficit of $428.5 million as of March 31, 2025. We expect our cash requirements to be significant in the future. The amount and timing of our future cash requirements will depend on regulatory and market acceptance of our drug candidates, the resources we devote to researching and developing, formulating, manufacturing, commercializing and supporting our products and other corporate needs. We believe that our current cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months. We may seek additional future funding through public or private financing in the future, if such funding is available and on terms acceptable to us. However, there are no assurances that additional financing will be available on favorable terms, or at all.

Current wording

We have an accumulated deficit of $472.7 million as of June 30, 2025. We expect our cash requirements to be significant in the future. The amount and timing of our future cash requirements will depend on regulatory and market acceptance of our drug candidates, the resources we devote to researching and developing, formulating, manufacturing, commercializing and supporting our products and other corporate needs. We believe that our current cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months. We may seek additional future funding through public or private financing in the future, if such funding is available and on terms acceptable to us. However, there are no assurances that additional financing will be available on favorable terms, or at all.