Trading after the bell was relatively muted on Thursday, with small-cap biotech names showing modest shifts. Delcath Systems edged higher following its buyback announcement, while BioVie, Cassava Sciences, and Enlivex Therapeutics rebounded despite a lack of fresh headlines.Delcath Systems, Inc. (DCTH) rose in after-hours trading to $8.52, up 4.02% or $0.33. Earlier in the day, the stock had closed at $8.19, down 3.76% or $0.32. The rebound followed the company's announcement of a $25 million share repurch ...

Drug Development and Clinical Trials - Cassava Sciences is focusing on developing simufilam for Tuberous Sclerosis Complex (TSC)-related epilepsy, with plans to initiate a proof-of-concept clinical trial in the first half of 2026[149]. - The company has entered into a License Agreement with Yale, granting exclusive worldwide rights for the development and commercialization of simufilam, with potential milestone payments totaling up to $4.5 million[150][151]. - Simufilam has shown promising preclinical results in reducing seizure activity in TSC-related epilepsy models, with a statistically significant correlation between dosage and seizure frequency[148]. - The company has sole ownership of patents covering simufilam's composition and methods of use in multiple jurisdictions, with U.S. patent protection expiring between 2029 and 2040[141]. - Tuberous Sclerosis Complex affects approximately 50,000 people in the U.S. and over one million worldwide, with 84% of patients experiencing epilepsy[142]. - The company has appointed Dr. Joseph Hulihan as Chief Medical Officer to oversee the clinical development of simufilam, bringing over 25 years of industry experience[149]. - Cassava Sciences has conducted preclinical studies indicating that simufilam may effectively reduce TSC-related seizure activity, as demonstrated in research published in peer-reviewed journals[143][145]. - Simufilam targets the protein filamin A (FLNA), which is linked to seizures and neuronal abnormalities in TSC patients[140]. - The company intends to continue exploratory preclinical studies in collaboration with researchers to better understand simufilam's potential for treating TSC-related seizures[170]. - Preclinical studies indicated that simufilam may reduce seizure activity in TSC-related epilepsy models, suggesting its potential beyond Alzheimer's disease[168]. Alzheimer's Disease Program - The Phase 3 RETHINK-ALZ study of simufilam in mild-to-moderate Alzheimer's disease did not meet its co-primary endpoints, with no significant change in cognition and function compared to placebo after 52 weeks[157]. - The Phase 3 REFOCUS-ALZ study, which enrolled 1,125 patients, was also discontinued after failing to meet pre-specified endpoints, with no significant differences in cognitive and functional measures compared to placebo after 76 weeks[159]. - The company announced the decision to phase out its Alzheimer's disease development program following the disappointing results from both Phase 3 studies, completed in Q2 2025[160]. - The investigational product candidate SavaDx, aimed at detecting Alzheimer's disease from a blood sample, was discontinued due to business and technical reasons, accounting for less than 1% of the research budget[177]. Financial Performance and Expenses - As of September 30, 2025, the company has an accumulated deficit of $483.5 million, primarily due to research and development costs, salaries, and legal expenses[182]. - Research and development expenses decreased by 78% to $4.0 million for the three months ended September 30, 2025, compared to $17.7 million in the same period of 2024, mainly due to the phase-out of the Alzheimer's disease program[190]. - General and administrative expenses were $7.9 million for the three months ended September 30, 2025, a 39% decrease from $12.9 million in the same period of 2024, attributed to lower legal costs and severance expenses[195]. - Interest income decreased to $1.2 million for the three months ended September 30, 2025, down from $2.6 million in the same period of 2024, due to lower interest rates and cash balances[198]. - Cash and cash equivalents were $106.1 million as of September 30, 2025, with expectations of continued significant cash usage in operations for the next several years[205]. - The company expects research and development expenses to decrease further now that the Alzheimer's disease program has been phased out, with lower costs anticipated for the TSC-related epilepsy program[193]. - The company recorded other losses of $(0.1) million for the three months ended September 30, 2025, due to higher vacancy rates compared to the prior year[203]. - The company plans to continue using capital resources for research and development, capital expenditures, and general corporate purposes[205]. - The company expects general and administrative expenses to remain high compared to historic levels due to ongoing litigation and increased stock-based compensation expenses[197]. - Net cash used in operating activities was $22.5 million for the nine months ended September 30, 2025, primarily due to a net loss of $78.4 million[215]. - The company has an accumulated deficit of $483.5 million as of September 30, 2025, and expects significant future cash requirements[220]. - Net cash provided by financing activities was $0.1 million for the nine months ended September 30, 2025, from the exercise of stock options[218]. - The company occupied approximately 25% of its office complex in Austin, Texas, with higher vacancy rates expected to significantly lower rental income in 2025[219]. - No cash payments were authorized or made to participants under the 2020 Cash Incentive Bonus Plan as of September 30, 2025[214]. - Net cash used in investing activities was $0.1 million for the nine months ended September 30, 2025, primarily for tenant improvements[217]. - The company recorded a net cash used in operating activities of $55.7 million for the nine months ended September 30, 2024, primarily due to a change in fair value of warrants of $108.2 million[216]. - The company may seek additional future funding through public or private financing, but there are no assurances that such financing will be available on favorable terms[220]. - Total cost of warrant exercises through the Redemption Date was approximately $2.7 million[213]. - The company expects to record a net loss on leasing activities in 2025 due to unfilled tenant leases[219]. Research and Development Strategy - The company is leveraging its scientific platform to develop first-in-class programs targeting central nervous system disorders[138]. - The company is focusing on targeting the scaffolding protein FLNA for potential treatments of central nervous system disorders, including TSC-related epilepsy[164]. - The company owns worldwide rights to its development program, including critical intellectual property rights that are essential for its competitive position[178]. - The company is exploring potential applications of artificial intelligence to enhance productivity and efficiency in research and development activities[171].

Financial Performance - Net loss for Q3 2025 was $10.8 million, or $0.22 per share, a significant improvement from a net loss of $27.9 million, or $0.58 per share, in Q3 2024[3][10]. - Incremental cash use of $10 to $14 million is expected in Q4 2025, reflecting a downward revision from previous guidance for the second half of 2025[4][10]. - The accumulated deficit increased from $(405,111,000) to $(483,545,000), indicating a worsening financial position[23]. Cash and Assets - Cash and cash equivalents were $106.1 million as of September 30, 2025, down from $128.6 million at the end of 2024, with an estimated cash range of $92 to $96 million expected by year-end 2025[4][10]. - Total current assets decreased from $136,532,000 on December 31, 2024, to $108,910,000 on September 30, 2025, representing a decline of approximately 20.2%[23]. - Cash and cash equivalents decreased from $128,574,000 to $106,080,000, a reduction of about 17.5%[23]. - Common stock and additional paid-in-capital rose from $550,815,000 to $565,113,000, an increase of about 2.4%[23]. - Property and equipment, net slightly decreased from $21,001,000 to $20,823,000, a decline of approximately 0.8%[23]. Liabilities - Total liabilities increased significantly from $11,829,000 to $48,165,000, marking an increase of approximately 306.5%[23]. - Current liabilities surged from $11,750,000 to $48,046,000, reflecting an increase of around 308.5%[23]. - Accounts payable and other accrued expenses increased dramatically from $7,654,000 to $46,092,000, an increase of about 503.5%[23]. - Other non-current liabilities increased from $79,000 to $119,000, reflecting a growth of approximately 50.6%[23]. Expenses - Research and development (R&D) expenses decreased by 78% to $4.0 million in Q3 2025, compared to $17.7 million in Q3 2024, primarily due to the phase-out of the Alzheimer's disease development program[10]. - General and administrative (G&A) expenses were $7.9 million in Q3 2025, down 39% from $12.9 million in Q3 2024, attributed to reduced legal costs and absence of severance costs[10]. Clinical Development - The company plans to initiate a proof-of-concept study for simufilam in TSC-related epilepsy in the first half of 2026, building on positive preclinical results[5][7]. - Simufilam demonstrated a 60% reduction in seizure frequency in a mouse model of focal onset seizures, supporting its potential as a first-in-class treatment[7][10]. - The company has appointed Joseph Hulihan, MD, as Chief Medical Officer, enhancing its leadership in clinical development for TSC-related epilepsy[10]. Share Information - Total shares outstanding as of November 10, 2025, were 48.3 million[10]. - The company maintains a $31.25 million estimated loss contingency related to potential securities litigation, with unclear timing for any settlement payment[4][10].

Core Viewpoint - Cassava Sciences, Inc. has reported significant financial improvements and advancements in its research and development efforts, particularly focusing on simufilam as a potential treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy, with plans for a proof-of-concept study in H1 2026 [4][10]. Financial Results - The net loss for Q3 2025 was $10.8 million, or $0.22 per share, a notable decrease from a net loss of $27.9 million, or $0.58 per share, in Q3 2024 [2][10]. - Cash and cash equivalents stood at $106.1 million as of September 30, 2025, down from $128.6 million at the end of 2024, with an estimated cash range of $92 to $96 million expected by year-end 2025 [3][9]. - Research and development expenses for Q3 2025 were $4.0 million, a 78% decrease from $17.7 million in Q3 2024, primarily due to the completion of the Alzheimer's disease development program [10][19]. - General and administrative expenses were $7.9 million in Q3 2025, down 39% from $12.9 million in Q3 2024, attributed to reduced legal costs and absence of severance costs from the prior year [10][19]. Business Updates - Cassava is advancing simufilam as a potential treatment for TSC-related epilepsy, with positive preclinical results indicating a 60% reduction in seizure frequency in a mouse model [6][10]. - The company has strengthened its strategic capabilities by appointing experienced neuroscience leaders and expanding its Board of Directors [5][10]. - A collaboration with the TSC Alliance is underway to initiate a proof-of-concept study for simufilam in TSC-related epilepsy, expected to begin in the first half of 2026 [4][10]. Industry Context - Tuberous Sclerosis Complex (TSC) affects approximately 50,000 people in the US, with epilepsy being a common condition among TSC patients, occurring in 84% of cases [10][11]. - Current therapies for TSC-related epilepsy are often ineffective and associated with serious adverse events, highlighting the need for novel treatments like simufilam [11][12].

Core Viewpoint - Cassava Sciences, Inc. has appointed Ms. Dawn C. Bir to its Board of Directors, which is seen as a strategic move as the company prepares to initiate its first clinical study for simufilam in Tuberous Sclerosis Complex (TSC)-related epilepsy in the first half of 2026 [1][3]. Company Overview - Cassava Sciences, Inc. is a biotechnology company focused on developing investigational treatments for central nervous system disorders, including TSC-related epilepsy [4]. - The company's lead product, simufilam, is an oral small molecule believed to modulate the activity of the filamin A protein, which plays a role in neuronal development [4]. Appointment of Dawn C. Bir - Dawn C. Bir is a seasoned biopharmaceutical executive with a history of contributing to the growth and commercialization of biotechnology companies [2]. - Her previous roles include Interim President and CEO of Geron Corporation and Executive Vice President and Chief Commercial Officer at Reata Pharmaceuticals, where she was instrumental in the company's acquisition by Biogen [2][3]. - The Board believes that Ms. Bir's experience in building shareholder value and her relationships with market stakeholders will be beneficial as Cassava advances its clinical programs [3]. Strategic Importance - The appointment of Ms. Bir is considered pivotal for Cassava as it seeks to enhance its strategic capabilities in preparation for the upcoming clinical study [3]. - Ms. Bir expressed her commitment to delivering transformative therapies for TSC-related epilepsy and is eager to collaborate with the management team to guide business and clinical strategies [3].

Group 1 - The article discusses the recent failure of Cassava Sciences' drug program for Alzheimer's disease and the company's decision to move away from this area of research [1] - The author emphasizes a focus on growth markets, particularly in AI and biotech, while also exploring undervalued stocks with significant potential [1] - The investment strategy is influenced by Warren Buffett's principles but applied to riskier investments, with a portfolio that spans from megacap to microcap stocks [1] Group 2 - The author has been investing since 2021 and has a vast network for sharing insights, focusing primarily on the U.S. market but occasionally considering European or Canadian stocks [1] - The investment portfolio includes sectors such as semiconductor, mining, and biotech, with a particular interest in companies that are under-the-radar [1] - The author holds a Master's Degree in Law and serves as the deputy director general in a leading European sector organization [1]

Group 1: Super League Enterprise, Inc. - Super League Enterprise, Inc. announced a $10 million strategic equity investment from Evo Fund, leading to a sharp increase in its stock price [1] - Shares of Super League Enterprise rose 200% to $9.83 in pre-market trading following the announcement [1] Group 2: Other Notable Gainers - Professional Diversity Network, Inc. gained 88.8% to $5.40 in pre-market trading after a previous rise of around 4% [4] - STRATA Skin Sciences, Inc. rose 80% to $3.06 in pre-market trading after an 8% increase on Monday [4] - Jiuzi Holdings, Inc. jumped 50.9% to $1.69 in pre-market trading after a 5% gain on Monday [4] - New Era Energy & Digital, Inc. gained 47.2% to $0.8941 in pre-market trading after a surge of around 12% on Monday [4] - Better Home & Finance Holding Company increased by 30% to $64.95 in pre-market trading, following a 46% jump on Monday [4] - MicroCloud Hologram Inc. surged 29% to $7.17 in pre-market trading after announcing a breakthrough in quantum technology [4] - Cassava Sciences, Inc. rose 24.1% to $2.88 in pre-market trading after CEO Richard Barry purchased shares at an average price of $2.25 [4] - SES AI Corporation surged 10.3% to $2.04 in pre-market trading after a 17% increase on Monday [4] - Ballard Power Systems Inc. gained 8.3% to $3.12 in pre-market trading after a 5% rise on Monday [4] Group 3: Notable Decliners - Psyence Biomedical Ltd. dipped 19.6% to $3.65 in pre-market trading after a decline of around 5% on Monday [4] - Diginex Limited shares fell 17.7% to $14.60 in pre-market trading after a jump of over 30% on Monday [4] - Addentax Group Corp. declined 16.5% to $0.9021 in pre-market trading after gaining more than 30% on Monday [4] - Boxlight Corporation fell 15.5% to $4.03 in pre-market trading after a significant jump of 205% on Monday [4] - Reliance Global Group, Inc. dropped 15.5% to $0.9122 in pre-market trading after a 47% increase on Monday [4] - Qualigen Therapeutics, Inc. declined 14.1% to $4.75 in pre-market trading after a 95% jump on Monday [4] - Fly-E Group, Inc. fell 13.1% to $0.8773 in pre-market trading after announcing a securities purchase agreement [4] - Firefly Aerospace Inc. dropped 12.5% to $43.29 in pre-market trading after reporting a second-quarter loss [4] - Opendoor Technologies Inc. dipped 6.3% to $7.85 in pre-market trading after a 12% fall on Monday [4] - Symbotic Inc. fell 4.8% to $57.80 in pre-market trading after a gain of more than 6% on Monday [4]

Core Insights - Several biotech companies experienced significant stock price increases in after-hours trading, driven by clinical updates, strategic shifts, and upcoming catalysts [1] Cassava Sciences (SAVA) - Shares surged 37.1% to $3.18 in after-hours trading, following a regular session close of $2.32, which marked a 1.75% gain [2] - The rally is attributed to renewed interest in the investigational drug simufilam, particularly its potential in treating TSC-related epilepsy, following positive preclinical data [3] - Leadership changes, including the appointment of Dr. Joseph Hulihan as Chief Medical Officer, indicate a strategic pivot in clinical priorities [3] - Future updates on simufilam and the diagnostic candidate SavaDx could serve as near-term catalysts [4] Helius Medical Technologies (HSDT) - Stock rose 15.67% to $18.53 in after-hours trading after a regular session close of $16.02, where it had dropped 33.61% [4] - The rebound followed a $500 million private placement announcement, marking a significant pivot from its core neurotech focus [5] - Helius continues to advance its medical device pipeline, with positive results from the Portable Neuromodulation Stimulator (PoNS) stroke registrational program and plans for FDA submission [6] Werewolf Therapeutics (HOWL) - Shares increased 9.78% to $2.02 in after-hours trading, following a regular session close of $1.84, which was up 23.49% [6] - The company is advancing multiple conditionally activated cytokine therapies through its INDUKINE platform, with lead candidate WTX-124 in a Phase 1/1b trial targeting advanced solid tumors [7] - Participation in the H.C. Wainwright 27th Annual Global Investment Conference highlighted management's timelines for clinical readouts and pipeline progress [8] Aytu BioPharma Inc. (AYTU) - Stock rose 7.63% to $2.68 in after-hours trading after closing at $2.49, up 2.05% [8] - The price action follows the announcement of full-year and Q4 fiscal 2025 results expected on September 23, 2025, which will clarify commercial performance and progress with EXXUA [9] - Aytu maintains a portfolio of pediatric and ADHD-focused therapeutics and has extended its loan agreement with Eclipse to boost liquidity [10] Equillium Inc. (EQ) - Shares increased 10.34% to $1.60 in after-hours trading after closing at $1.45, down 0.68% [10] - The company announced up to $50 million in financing to advance EQ504 into clinical development, with positive feedback from the FDA regarding its regulatory pathway [11] - Its lead candidate, itolizumab (EQ001), is in Phase 3 trials for acute graft-versus-host disease and has completed earlier-stage studies in lupus nephritis and ulcerative colitis [11]

Summary of Cassava Sciences FY Conference Call Company Overview - **Company**: Cassava Sciences (NasdaqCM:SAVA) - **Industry**: Biotechnology, specifically focused on treatments for Alzheimer's disease and tuberous sclerosis complex (TSC) Key Points and Arguments 1. **Management Changes and Controversy**: The company faced significant controversy and investigations by government agencies, leading to the resignation of the CEO and Senior VP of Neuroscience in 2024. A settlement with the SEC was reached, allowing the company to move forward [4][5][21]. 2. **Focus on Alzheimer's Treatment**: Cassava Sciences is developing a drug, simufilam, aimed at treating Alzheimer's disease by addressing root causes rather than amyloid plaques, which is the focus of most existing drugs [3][4]. 3. **Transition to TSC Research**: Following the failure of phase 3 Alzheimer's trials, the company is pivoting to explore simufilam's potential in treating TSC-related epilepsy, leveraging promising preclinical results [10][18]. 4. **Market Opportunity in TSC**: There are approximately 50,000 TSC patients in the U.S., with 80% to 90% experiencing epilepsy. Current treatments do not provide adequate relief for over 60% of these patients, indicating a significant unmet need [14][15]. 5. **Safety Profile**: The safety profile of simufilam was noted to be remarkable, with no drug-related adverse events reported in over 1,200 patients during Alzheimer's trials [10][21]. 6. **Upcoming Clinical Trials**: A phase 2A proof-of-concept clinical trial for TSC is expected to begin in the first half of 2026, pending IND approval by the end of 2025 [22]. 7. **Financial Position**: As of June, the company had $112 million in cash and no debt. Estimated cash at the end of 2025 is projected to be between $61 million and $65 million, with operational burn rates of $16 to $20 million in the second half of the year [22][23]. Additional Important Information 1. **Research Collaboration**: The company is collaborating with Yale University and the TSC Alliance to further explore the efficacy of simufilam in TSC patients [9][12]. 2. **Expert Team**: The addition of Dr. Angelique Bordey, a leading expert in TSC, to the team is seen as a significant asset for the company's research efforts [12]. 3. **Preclinical Findings**: Preclinical studies in mouse models have shown promising results, including a 60% reduction in seizure frequency in the FCD2 model, indicating potential efficacy in humans [19][20]. 4. **Long-term Vision**: The company aims to address the root causes of diseases rather than just symptoms, which could lead to more effective treatments for patients suffering from TSC and Alzheimer's [18][21].

Core Insights - Cassava Sciences, Inc. is a biotechnology company focused on developing investigational treatments for central nervous system disorders, particularly Tuberous Sclerosis Complex-related epilepsy [1][4] - The company will participate in the H.C. Wainwright 27 Annual Global Investment Conference scheduled for September 8-10, 2025, in New York City [1][2] Company Overview - Cassava Sciences is based in Austin, Texas, and is developing a proprietary oral small molecule called simufilam, which is believed to modulate the activity of the filamin A protein, impacting neuronal development [4] - The company aims to address various CNS disorders with its investigational treatments [4] Conference Details - Rick Barry, the President and CEO of Cassava, will present at the conference on September 8, 2025, at 5 PM ET [2] - A replay of the webcast will be available on the Cassava Investor's website for approximately 90 days post-event [2]