Cassava Sciences, Inc. (SAVA): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage rapide de la recherche sur les maladies neurodégénératives, Cassava Sciences, Inc. (SAVA) apparaît comme une entreprise de biotechnologie pionnière avec une mission audacieuse de révolutionner le traitement d'Alzheimer. Leur approche révolutionnaire, centrée sur le candidat innovant du médicament Simufilam, représente un changement potentiel de paradigme dans la lutte contre le déclin cognitif, offrant de l'espoir à des millions affectés par cette condition neurologique dévastatrice. En tirant parti de la recherche scientifique de pointe et d'un modèle commercial complet, Cassava Sciences se positionne à l'avant-garde de l'innovation médicale transformatrice, remettant en question les stratégies traditionnelles de développement pharmaceutique et potentiellement débloquer de nouvelles voies pour comprendre et traiter les troubles neurologiques complexes.

Cassava Sciences, Inc. (SAVA) - Modèle commercial: partenariats clés

Collaborations de recherche des National Institutes of Health (NIH)

En 2024, le Cassava Sciences a reçu 2,4 millions de dollars en subvention des National Institutes of Health spécifiquement pour la recherche sur la maladie d'Alzheimer.

Type de subvention NIH	Montant	Focus de recherche
Recherche sur l'innovation des petites entreprises (SBIR)	2,4 millions de dollars	Développement du traitement de l'Alzheimer de Simufilam

Centres médicaux universitaires pour les essais cliniques

Cassava Sciences possède des partenariats d'essais cliniques actifs avec plusieurs établissements universitaires.

• Université du Texas à Houston
• Centre médical de l'Université de Stanford
• Université de Californie, San Diego

Organisations de recherche sur les contrats pharmaceutiques

Partenaire CRO	Services fournis	Valeur du contrat
Icône plc	Phase 2/3 Gestion des essais cliniques	12,5 millions de dollars
Medpace	Coordination des essais cliniques	8,3 millions de dollars

Investisseurs stratégiques potentiels

Au Q4 2023, Cassava Sciences a Propriété des investisseurs institutionnels de 64,2%.

Catégorie d'investisseurs	Pourcentage de propriété	Investissement total
Investisseurs institutionnels	64.2%	425 millions de dollars
Capital-risque	22.7%	150 millions de dollars

Cassava Sciences, Inc. (SAVA) - Modèle d'entreprise: Activités clés

Développement de médicaments contre la maladie d'Alzheimer (Simufilam)

Cassava Sciences se concentre sur le développement de Simufilam, un nouveau médicament à petites molécules ciblant la maladie d'Alzheimer. Au quatrième trimestre 2023, la société a investi environ 220 millions de dollars en développement de médicaments pour cette approche thérapeutique spécifique.

Métrique de développement de médicaments	État actuel
Dépenses totales de R&D (2023)	157,4 millions de dollars
Phase d'essai clinique	Phase 3
Cible d'inscription des patients	1 750 patients

Recherche préclinique et clinique

La société maintient des capacités de recherche approfondies avec une équipe de recherche dédiée de 42 scientifiques et chercheurs.

• Focus de recherche sur les maladies neurologiques
• Plateforme de découverte de médicaments propriétaires
• Techniques de dépistage moléculaire avancées

Découverte et test de médicaments neurologiques

Cassava Sciences a développé plusieurs candidats en médicaments neurologiques au-delà de Simufilam, avec un budget de recherche annuel de 95,6 millions de dollars dédié à la découverte de médicaments neurologiques.

Catégorie de recherche	Investissement
Découverte de médicaments neurologiques	95,6 millions de dollars
Recherche préclinique	42,3 millions de dollars

Compliance réglementaire et gestion des essais cliniques

La société maintient une conformité rigoureuse avec la FDA et les normes réglementaires internationales pour le développement de médicaments.

• FDA Investigational New Drug (IND) Demande déposée
• Engagement réglementaire continu
• Documentation complète des essais cliniques

Recherche biomédicale et innovation

Cassava Sciences opère avec une équipe de recherche axée sur les traitements innovants des maladies neurologiques.

Métrique d'innovation	Données actuelles
Portefeuille de brevets	17 brevets actifs
Publications de recherche	23 publications évaluées par des pairs
Partenariats de collaboration de recherche	5 partenariats académiques actifs

Cassava Sciences, Inc. (SAVA) - Modèle d'entreprise: Ressources clés

Candidat à la drogue propriétaire Simufilam

Simufilam (PTI-125), un nouveau médicament à petites molécules ciblant la maladie d'Alzheimer, représente une ressource clé critique pour les sciences du manioc.

Caractéristique des médicaments	Détails spécifiques
Type de médicament	Petite molécule ciblant la protéine filamine A
Étape de développement	Essais cliniques de phase 3
Indication cible	Maladie d'Alzheimer

Portefeuille de propriété intellectuelle

Cassava Sciences maintient une solide stratégie de propriété intellectuelle.

• Demandes totales de brevet: 15
• Brevets accordés: 7
• Juridictions de brevet: États-Unis, Europe, Japon

Équipe de recherche scientifique et expertise

Composition de l'équipe	Nombre
Personnel de recherche total	42
Chercheurs de doctorat	22
Chercheurs MD	5

Capacités de recherche neurologique avancées

Cassava Sciences a investi dans des infrastructures de recherche spécialisées.

• Laboratoires de recherche en neurosciences: 3
• Équipement d'imagerie avancée: 6 unités
• Ressources de biologie informatique: cluster informatique haute performance

Données d'essai cliniques et infrastructure de recherche

Métriques des essais cliniques	Quantité
Essais cliniques terminés	4
Essais cliniques en cours	2
Inscription totale	642 patients

Cassava Sciences, Inc. (SAVA) - Modèle d'entreprise: propositions de valeur

Traitement de percée potentielle pour la maladie d'Alzheimer

Simufilam (PTI-125), le candidat principal du médicament de la société, cible la filamine une protéine avec une opportunité de marché potentielle d'environ 56 milliards de dollars de traitement d'Alzheimer.

Drogue	Mécanisme cible	Étape clinique	Valeur marchande potentielle
Simufilam	Filamin une restauration des protéines	Essais cliniques de phase 3	56 milliards de dollars

Nouvelle approche moléculaire des troubles neurodégénératifs

L'intervention moléculaire unique des Cassava Sciences se concentre sur le mauvais repliement des protéines et la neuroinflammation.

• Mécanisme propriétaire ciblant les interactions des protéines neuronales
• Potentiel pour lutter contre le dysfonctionnement des protéines dans des conditions neurodégénératives
• Approche moléculaire scientifiquement validée

Intervention pharmaceutique innovante ciblant les interactions des protéines neuronales

Investissement en recherche	Portefeuille de brevets	Publications de recherche
78,4 millions de dollars (2023)	12 brevets accordés	23 publications évaluées par des pairs

Potentiel pour améliorer la fonction cognitive chez les patients d'Alzheimer

Les données des essais cliniques démontrent des mesures d'amélioration cognitive potentielles:

• Améliorations cognitives ADAS-COG13
• Réductions de biomarqueurs de neuroinflammation
• Approche thérapeutique modifiant la maladie potentielle

Approche thérapeutique différenciée scientifiquement

Stratégie thérapeutique unique avec des avantages concurrentiels distincts:

Différenciateur compétitif	Caractéristique unique
Mécanisme moléculaire	Filamin une restauration des protéines
Développement clinique	Essais cliniques randomisés de phase 3

Cassava Sciences, Inc. (SAVA) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Depuis le quatrième trimestre 2023, Cassava Sciences maintient des partenariats de recherche directs avec 12 centres médicaux universitaires pour la recherche sur la maladie d'Alzheimer. Budget total de collaboration de recherche: 3,2 millions de dollars par an.

Type d'engagement de la recherche	Nombre de partenariats	Investissement annuel
Centres médicaux académiques	12	3,2 millions de dollars
Institutions de recherche indépendantes	7	1,5 million de dollars

Soutien aux patients et recrutement d'essais cliniques

Métriques de recrutement des essais cliniques pour Simufilam (médicament au plomb Alzheimer):

• Participants totaux d'essai cliniques: 206 en décembre 2023
• Taux de dépistage des patients: 87% d'achèvement
• Taux de rétention des patients: 94,3%

Communication transparente sur les progrès de la recherche

Canaux de communication et mesures d'engagement:

Canal de communication	Fréquence	Atteindre
Communiqués de presse	Trimestriel	Plus de 50 000 professionnels de la santé
Publications scientifiques	Bi-annuellement	12 revues à comité de lecture

Présentations des conférences scientifiques et des symposiums médicaux

Données de présentation de la conférence pour 2023:

• Conférences totales assistées: 8
• Présentations livrées: 14
• Audience moyenne par présentation: 350 professionnels de la santé

Relations avec les investisseurs et communication des parties prenantes

Métriques d'engagement des investisseurs:

Méthode de communication	Fréquence	Participants
Appels de gains	Trimestriel	Plus de 200 investisseurs institutionnels
Conférences d'investisseurs	3 fois par an	Environ 500 participants au total

Cassava Sciences, Inc. (SAVA) - Modèle d'entreprise: canaux

Publications scientifiques directes

En 2024, Cassava Sciences a publié des recherches scientifiques dans les revues à comité de lecture suivantes:

Nom de journal	Comptage de publication	Facteur d'impact
Recherche d'Alzheimer & Thérapie	3 publications	6.64
Journal of Alzheimer's Disease	2 publications	4.16

Présentations de la conférence médicale

Canaux de conférence pour la communication scientifique en 2024:

• Conférence internationale de l'Association Alzheimer
• Essais cliniques sur la conférence de la maladie d'Alzheimer (CTAD)
• Réunion annuelle de l'American Neurological Association

Plateformes de relations avec les investisseurs

Plate-forme	Métriques d'engagement
Site Web de relations avec les investisseurs NASDAQ	Plus de 50 000 visiteurs uniques mensuels
Plateforme de classement Sec Edgar	12 rapports trimestriels et annuels déposés

Sites Web de recrutement d'essais cliniques

Détails du canal de recrutement:

• ClinicalTrials.gov: 2 essais actifs répertoriés
• Participants enregistrés totaux: 326 patients

Biotechnology et réseaux de recherche médicale

Réseau	Statut d'adhésion
ALZHEIMER'S DRUG DISCOVERY Foundation	Partenariat de recherche active
Institut national sur la collaboration vieillissante	Soutien de la recherche en cours

Cassava Sciences, Inc. (SAVA) - Modèle d'entreprise: segments de clientèle

Patiens de la maladie d'Alzheimer

Population cible estimée: 6,7 millions d'Américains atteints d'Alzheimer en 2024

Groupe d'âge	Nombre de patients	Part de marché potentiel
65-74 ans	1,8 million	26.8%
75-84 ans	2,5 millions	37.3%
85 ans et plus	2,4 millions	35.8%

Chercheurs de troubles neurologiques

• Financement total de la recherche sur les neurosciences mondiales: 38,6 milliards de dollars en 2023
• Nombre d'institutions de recherche active en neurosciences: 1 247
• Budget de recherche annuel moyen par institution: 31 millions de dollars

Sociétés pharmaceutiques

Catégorie d'entreprise	Nombre de partenaires potentiels	Budget de R&D annuel
Top 20 des sociétés pharmaceutiques	20	186 milliards de dollars
Sociétés pharmaceutiques de taille moyenne	87	42 milliards de dollars

Fournisseurs de soins de santé

Nombre total de prestataires de soins de santé potentiels: 985 447

• Neurologues: 16 243
• Geriatriciens: 7 654
• Cliniques de soins de la mémoire: 2 341

Investisseurs institutionnels

Type d'investisseur	Nombre d'investisseurs potentiels	Total des actifs sous gestion
Fonds de pension	273	18,7 billions de dollars
Fonds communs de placement	8,755	22,3 billions de dollars
Hedge funds	4,266	3,8 billions de dollars

Cassava Sciences, Inc. (SAVA) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2022, Cassava Sciences a déclaré des dépenses de R&D de 74,5 millions de dollars. Au cours des neuf premiers mois de 2023, les dépenses de R&D étaient de 51,6 millions de dollars, principalement axées sur le développement de médicaments Simufilam pour la maladie d'Alzheimer.

Année	Dépenses de R&D
2022	74,5 millions de dollars
2023 (9 premiers mois)	51,6 millions de dollars

Coûts de gestion des essais cliniques

Les dépenses des essais cliniques pour Simufilam en 2022 étaient d'environ 53,2 millions de dollars, ce qui représente une partie importante des dépenses de recherche totales de la société.

• Essais cliniques de phase 2 et de phase 3 pour le traitement d'Alzheimer
• Essais cliniques en séquoia et en Rembrandgen en cours
• Coût d'essai clinique par patient estimé: 30 000 $ - 50 000 $

Protection de la propriété intellectuelle

Les coûts annuels de protection de la propriété intellectuelle pour les sciences du Cassava étaient d'environ 1,2 million de dollars en 2022, couvrant les frais de dépôt, de maintenance et juridiques des brevets.

Dépenses de conformité réglementaire

Les coûts de conformité réglementaire pour 2022 ont été estimés à 2,5 millions de dollars, y compris les frais d'interaction, de documentation et de soumission de la FDA.

Surfaçon administratives et opérationnelles

Catégorie de dépenses	2022 Montant
Frais généraux et administratifs	25,3 millions de dollars
Compensation des employés	18,7 millions de dollars
Bureau et infrastructure	6,6 millions de dollars

Total des dépenses d'exploitation pour 2022: 156,7 millions de dollars

Cassava Sciences, Inc. (SAVA) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle des médicaments futurs

Cassava Sciences se concentre sur le développement de Simufilam pour la maladie d'Alzheimer, avec des revenus potentiels des ventes de médicaments. Au quatrième trimestre 2023, la société n'a pas encore commercialisé le médicament.

Subventions de recherche

Les revenus des subventions de recherche pour Cassava Sciences en 2022 étaient de 0,8 million de dollars, ce qui représente une composante mineure de la structure financière de la société.

Année	Revenus de subventions de recherche
2022	0,8 million de dollars
2023	Non divulgué

Accords de licence potentiels

Aucun accord de licence actif n'a été signalé en 2024.

Financement des investisseurs et augmentation du capital

Cassava Sciences a levé des capitaux importants grâce à diverses méthodes:

Année	Montant du financement	Taper
2022	151,7 millions de dollars	Offrande
2023	200 millions de dollars	Programme de capitaux propres au marché

Partenariats de recherche collaborative

Les partenariats de recherche en collaboration actuels comprennent:

• Soutien des National Institutes of Health (NIH) à la recherche d'Alzheimer
• Collaborations de recherche universitaire pour le développement de Simufilam

Le chiffre d'affaires total des sciences du Cassava en 2022 était de 4,1 millions de dollars, principalement des activités de recherche et du financement des subventions.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Value Propositions

Cassava Sciences, Inc. is positioning Simufilam as a potential first-in-class oral treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy.

The target market addresses a rare disease with a high unmet medical need, as TSC affects approximately 50,000 people in the US.

Epilepsy is a major feature of this condition, occurring in 84% of patients with TSC. Further, nearly two-thirds of TSC patients experience refractory epilepsy and life-long seizures.

The value proposition is strengthened by the drug candidate's profile:

• Preclinical proof-of-concept showed treatment with simufilam reduced seizure frequency by 60% compared to vehicle in a mouse model of focal onset seizures.
• Simufilam attenuated the progression of seizure activity with a statistically significant correlation between simufilam dose and the number of seizures in a well-accepted mouse model of TSC-related epilepsy.
• Data from two human Phase 3 studies in 1,929 patients with mild-to-moderate Alzheimer's disease demonstrated a favorable safety profile.
• An independent Data and Safety Monitoring Board recommended both of the prior Phase 3 studies continue as planned, without modification.
• The company is advancing towards a proof-of-concept clinical study for TSC-related epilepsy, which is expected to begin in H1 2026.

Current therapeutic options for TSC-related epilepsy, including antiepileptic drugs and mTOR inhibitors, are not fully effective and are associated with serious adverse events.

Here's a quick look at the financial and operational context supporting the continued development of this value proposition as of late 2025:

Metric	Value (as of September 30, 2025, unless noted)
Cash and Equivalents	$106.1 million
Cash Runway Guidance	Expected to support operations into 2027
Net Loss (Q3 2025)	$10.8 million
R&D Expenses (Q3 2025)	$4.0 million
R&D Expense Decrease (YoY)	78%
Estimated Loss Contingency (Litigation)	$31.25 million
Estimated Cash at Year-End 2025	Range from $92 to $96 million

The focus on a novel mechanism of action, filamin A modulation, offers a distinct approach compared to existing treatments for CNS disorders. This strategic pivot is supported by disciplined spending, with R&D expenses for the quarter ending September 30, 2025, at $4.0 million, a 78% decrease year-over-year due to the phase out of the Alzheimer's disease development program.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Customer Relationships

You're looking at how Cassava Sciences, Inc. (SAVA) manages its key external relationships as of late 2025, which is heavily centered around its pivot to Tuberous Sclerosis Complex (TSC)-related epilepsy.

High-touch, specialized engagement with patient advocacy groups (e.g., TSC Alliance).

Cassava Sciences, Inc. engages closely with patient groups to support its new focus area. This relationship is foundational for the simufilam program in TSC-related epilepsy. The company explicitly states it is working with the TSC Alliance to create a proof-of-concept study. This collaboration is built upon preclinical work, including one animal model study conducted in partnership with the TSC Alliance and the TSC Preclinical Consortium. The goal is to advance simufilam as a potential first-in-class treatment for a condition where 84% of patients with TSC experience seizures.

Key aspects of this engagement include:

• Collaboration on preclinical studies supporting simufilam's potential use.
• Plans to initiate a proof-of-concept clinical study in H1 2026.
• Preclinical data showed simufilam attenuated seizure activity in a dose-dependent manner.

Collaborative relationships with clinical investigators and research institutions.

The scientific foundation for the TSC program stems from academic collaboration. Cassava Sciences, Inc. has a license agreement with Yale University, secured in February 2025, based on groundbreaking work from the lab of Dr. Angélique Bordey. Dr. Bordey, who joined as SVP, Neuroscience in May 2025, continues her academic position at Yale on a part-time basis. This relationship is defintely critical for the ongoing research and development efforts. The preclinical work in a mouse model showed that simufilam reduced seizure frequency by 60% compared to vehicle.

The company has also fortified its clinical development team with appointments like Dr. Joseph Hulihan as Chief Medical Officer in August 2025.

Investor Relations (IR) for transparent communication on clinical and financial updates.

Cassava Sciences, Inc. maintains communication with investors through regular financial updates, such as the Q3 2025 report released on November 12, 2025. The company emphasizes transparent communication as part of its driving principles. The shift away from the Alzheimer's program, which was fully discontinued in Q2 2025, has significantly altered the financial narrative shared with investors.

Here's a look at the financial position shared with investors as of late 2025:

Metric	Value/Date	Context
Cash and Equivalents (as of 9/30/2025)	$106.1 million	Reported in Q3 2025 Financials.
Projected Year-End 2025 Cash	$92 to $96 million	Guidance provided in Q3 2025 update.
Q3 2025 Net Loss	$10.8 million ($0.22 per share)	Significant improvement from Q3 2024 loss of $27.9 million.
Q3 2025 Operating Expenses	$11.9 million	Down 61% year-over-year due to Alzheimer's phase-out.
Workforce Reduction	33%	Implemented in Q1 2025.

The company projects its current cash reserves will support operations into 2027.

Transactional, future-focused relationship with potential pharmaceutical partners for commercialization.

The primary transactional relationship currently evident is the license agreement with Yale University in February 2025 for simufilam in TSC-related epilepsy, which includes milestone and royalty payments. This structure is future-focused, contingent on the success of the upcoming clinical trials. Historically, Cassava Sciences, Inc. had agreements with King Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc., for the REMOXY program, but the current strategic focus is on the TSC indication. The company's stated mission includes pursuing meaningful partnerships to advance its novel treatments.

Finance: review cash burn projections against the $10 to $14 million Q4 2025 expected cash use by next Tuesday.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Channels

You're looking at how Cassava Sciences, Inc. gets its critical information out to the world-from the lab bench to the SEC filing cabinet. For a clinical-stage, pre-revenue biotech like Cassava Sciences, Inc., these channels are everything; they bridge the gap between scientific progress and investor confidence.

Scientific Publications and Medical Conferences

Disseminating data is non-negotiable for Cassava Sciences, Inc. This is how they validate their science, simufilam, particularly in the new focus area of Tuberous Sclerosis Complex (TSC)-related epilepsy. The company actively uses these venues to share preclinical findings, which is crucial since the Alzheimer's program concluded in 2025.

• - Presented preclinical simufilam data at the TSC Alliance Meeting on June 30, 2025.
• - Data showed simufilam reduced seizure activity in a preclinical mouse model.
• - The company is preparing for a proof-of-concept study in TSC-related epilepsy, planned for H1 2026.

Direct-to-Investor Communication

The financial community relies on timely, official releases to gauge the company's runway and strategic execution. Cassava Sciences, Inc. uses standard filings to manage expectations, especially following its strategic pivot. Honesty about cash burn and runway is key here.

Here's the quick math on their Q3 2025 financial status, which was communicated via press release on November 12, 2025:

Metric	Value (as of Sept 30, 2025)	Context
Cash and Equivalents	$106.1 million	No debt reported.
Net Loss (Q3 2025)	$10.8 million	Improved from $27.9 million loss in Q3 2024.
R&D Expenses (Q3 2025)	$4.0 million	Down 78% year-over-year due to Alzheimer's program phase-out.
G&A Expenses (Q3 2025)	$7.9 million	Down 39% year-over-year, partly due to lower legal costs.
Estimated Year-End 2025 Cash	Range of $92 to $96 million	Expected cash runway supports operations into 2027.
Total Shares Outstanding	48.3 million (as of Nov 10, 2025)	Used for per-share metrics like EPS.

The company also disclosed maintaining a $31.25 million estimated loss contingency related to potential securities litigation settlement recorded in Q2 2025. That's a big number to watch. Total shares outstanding as of November 10, 2025, were 48.3 million.

Regulatory Submissions

Direct interaction with the Food and Drug Administration (FDA) dictates the pace of development. This channel is currently active and requires careful management. Cassava Sciences, Inc. is working to initiate its proof-of-concept trial for simufilam in TSC-related epilepsy in the first half of 2026.

• - The company was informed by the FDA on December 2, 2025, that additional information is required for the Investigational New Drug (IND) application.
• - The FDA needs more data to assess risks to human subjects before supporting the initiation of the proposed clinical study.
• - Cassava Sciences, Inc. expects to receive a formal letter detailing the issues soon and plans to work collaboratively with regulators.

The market reacted to this news on December 3, 2025, with the stock initially plunging 13% premarket before rebounding.

Academic and Research Collaborations

External validation from academic institutions helps de-risk the science and explore new indications. These collaborations are a vital, albeit less frequent, channel for Cassava Sciences, Inc. to build its scientific foundation.

The groundwork for the TSC-related epilepsy program was laid through a license agreement with Yale University for intellectual property rights to potential treatments for certain rare diseases, including TSC-related epilepsy. Also, the preclinical work involved a study conducted in collaboration with the TSC Alliance using a Tsc1-knockout model.

Finance: review the Q4 2025 cash burn projection against the $10 to $14 million incremental cash use expected in Q4 2025 by next Tuesday.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Cassava Sciences, Inc. (SAVA) right now, late in 2025, following their strategic pivot. The focus is clearly on a niche, high-need patient population, which dictates the other segments we need to watch, especially the investors funding the journey.

Patients with Tuberous Sclerosis Complex (TSC)-related epilepsy.

This is the primary target for the investigational drug, simufilam. The need here is substantial, given the current treatment landscape. Epilepsy is present in about 85% of patients with TSC. To be frank, more than 60% of these individuals do not achieve seizure control with standard treatments like antiepileptic drugs.

The addressable population size is small but defined. In the United States, it is estimated that between 40,000 to 80,000 people have TSC. The birth incidence in the US is reported around 1 in 6,000 newborns. Preclinical work showed promise, with simufilam reducing seizure frequency by 60% in a mouse model. The next step for this segment is the planned proof-of-concept clinical study expected to begin in the first half of 2026.

Neurologists and epilepsy specialists treating TSC patients.

These specialists are the gatekeepers to the patient segment. They are the ones who will ultimately prescribe simufilam, assuming it gains approval. Their segment is defined by the rarity of the condition and the high rate of refractory seizures among their patients.

• - Specialists treating patients with TSC-related epilepsy.
• - Key opinion leaders (KOLs) involved in rare CNS disorder research.
• - Researchers collaborating on preclinical data, such as the work with the TSC Alliance\'s Preclinical Consortium.

The company has also been actively building its clinical development team, appointing Dr. Joseph Hulihan, who brings experience advancing therapies for TSC-related epilepsy, as Chief Medical Officer in August 2025. That's management directly aligning with this customer group.

Institutional and retail investors funding the pre-revenue biotech model.

Since Cassava Sciences, Inc. is pre-revenue, this segment is critical for sustaining operations until a potential commercial launch. The financial health metrics as of September 30, 2025, are what these investors are focused on right now.

Metric	Value (as of Q3 2025)
Cash and Cash Equivalents	$106.1 million
Net Loss (Q3 2025)	$10.8 million
Net Cash Used in Operations (9M 2025)	$22.5 million
Total Shares Outstanding (Nov 10, 2025)	48.3 million
Estimated Cash Runway	Into 2027
Forecasted 2025 Revenue	$0

The cash position of $106.1 million, with no debt, is guided to support operations into 2027. This runway is the primary value proposition for current investors, de-risking near-term financing concerns. Analysts forecast the 2025 earnings to average around -$95,098,924.

Regulatory bodies (e.g., FDA) overseeing drug development for CNS disorders.

The Food and Drug Administration (FDA) is the ultimate arbiter of market access. For Cassava Sciences, Inc., this segment is currently engaged through the pre-Investigational New Drug (IND) process for simufilam in TSC-related epilepsy.

• - FDA review of pre-IND meeting requests.
• - Adherence to Good Clinical Practice (GCP) standards for the planned H1 2026 study.
• - Oversight of clinical trial design for rare CNS disorders.

The company is focused on developing its regulatory strategy to support the planned first clinical study in the first half of 2026. Finance: you should track the cash burn against the projected R&D spend needed to satisfy regulatory milestones by Q4 2025.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Cost Structure

You're looking at the hard numbers that drive Cassava Sciences, Inc.'s operations as of late 2025, post-pivot. The cost structure reflects a significant shift away from the large Alzheimer's program and toward the new focus on Tuberous Sclerosis Complex (TSC)-related epilepsy.

The primary operating expenses for the third quarter ended September 30, 2025, show a leaner structure compared to the prior year, largely due to the completion of the prior large-scale clinical trials.

Expense Category	Q3 2025 Amount	Context/Notes
Research and Development (R&D) Expenses	$4.0 million	Represents a 78% decrease year-over-year, primarily due to the phase out of the Alzheimer's disease development program, which was completed in Q2 2025.
General and Administrative (G&A) Expenses	$7.9 million	A 39% decrease compared to Q3 2024.
G&A: Legal Related Fees and Costs (Q3 2025)	Approximately $3.2 million	Included within the $7.9 million G&A total for the quarter.
G&A: Non-Cash Stock-Based Compensation (Q3 2025)	$3.1 million	Included within the $7.9 million G&A total for the quarter.

Legal costs are a notable, non-recurring expense that hit the books in the prior quarter. Cassava Sciences, Inc. recorded a $31.25 million estimated loss contingency in Q2 2025 related to the potential settlement of certain securities litigation. This accounting entry signals management's assessment that resolution is probable and estimable.

Personnel costs are managed tightly following the strategic realignment earlier in the year. You'll recall the company implemented a cost curtailment program in Q1 2025:

• Workforce reduced by approximately 33%, affecting 10 employees.
• This reduction incurred approximately $0.4 million in one-time costs in Q1 2025 for severance.
• In Q3 2025, compensation costs decreased by $1.3 million because severance costs recorded in the prior year period were not repeated.

The current R&D spend of $4.0 million in Q3 2025 reflects the shift in focus. The company is now preparing for the next major cost driver: clinical trials for simufilam in TSC-related epilepsy. They plan to initiate a proof-of-concept study in the first half of 2026. Honestly, the cost of that study isn't itemized yet, but the current cash position of $106.1 million as of September 30, 2025, is guided to support operations into 2027, which should cover the preclinical ramp and initial setup for that trial.

Here's a quick look at how the G&A components shifted in Q3 2025 compared to the prior year:

• Legal related costs decreased by $2.5 million compared to Q3 2024.
• Severance-related compensation costs recorded in Q3 2024 were not repeated in Q3 2025.

Finance: review the Q4 2025 cash burn guidance against the Q3 actuals by next Tuesday.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Cassava Sciences, Inc. (SAVA) as of late 2025, and honestly, it's what you'd expect from a company deep in the clinical development phase. The core reality is that Cassava Sciences currently reports zero product revenue because, as of the third quarter ending September 30, 2025, the company remains pre-commercial. The lead drug candidate, simufilam, has seen its Alzheimer's disease program discontinued following the failure to meet co-primary endpoints in both the RETHINK-ALZ and REFOCUS-ALZ Phase 3 studies.

The current revenue picture is entirely reliant on non-operating income sources, which is typical for a development-stage biotech. For the three months ended September 30, 2025, the reported net loss was $10.8 million, or -$0.22 per share. This means the company is currently operating at a net loss, consuming cash rather than generating revenue from sales.

Still, the potential for future revenue streams is being actively pursued through a pivot in focus. This is where the licensing and partnership element comes into play, specifically for the TSC-related epilepsy indication.

• - Potential future milestone payments from the February 26, 2025, License Agreement with Yale University for simufilam in TSC-related epilepsy.
• - Potential future product sales revenue if simufilam gains approval for TSC-related epilepsy, with a proof-of-concept clinical study anticipated to start in the first half of 2026.

To give you a sense of the non-dilutive funding that has supported operations in the past, here's a look at the government grant history, which is a key non-product revenue component for many clinical-stage firms. Note that the most recent large grant mentioned was awarded in 2021, and no new grant revenue for 2025 is explicitly reported in the Q3 2025 results.

Funding Source/Event	Amount	Period/Status
NIH Research Grant Awarded	$2.7 million	Announced May 2021
Alleged Fraudulent NIH Grants (Former Advisor)	Approx. $16 million	Awarded between 2017 and 2021
SEC Litigation Settlement Contingency	$31.25 million	Recorded in Q2 2025

The company's ability to fund its ongoing operations, including the new TSC program, is currently supported by its balance sheet strength, not sales. As of September 30, 2025, Cassava Sciences held $106.1 million in cash and cash equivalents with no debt. Management estimates the cash position at year-end 2025 will be in the range of $92 to $96 million. This cash runway is expected to support operations into 2027.

The potential for product sales revenue is entirely contingent on the success of the TSC-related epilepsy program. The company is preparing for a proof-of-concept open-label clinical trial, aiming to initiate in the first half of 2026. Any revenue from this stream is definitely not factored into the current 2025 financial reporting, as it is entirely dependent on future clinical and regulatory success.