Please enable JS and disable any ad blocker Cassava Sciences (NASDAQ: SAVA) has appointed Dr Angélique Bordey as Senior Vice President of Neuroscience to lead the company's research and development efforts who currently serves as Vice Chair of the Department of Neurosurgery at Yale School of Medicine will maintain her academic position part-time while focusing on evaluating simufilam as a potential treatment for TSC-related epilepsy and other pipeline indications was fundamental to Cassava's recently granted patent for using simufilam to treat TSC-related epilepsy The company has secured a license agreement with Yale University for this patent Her expertise in neuroscience and leadership in the TSC community is expected to advance Cassava's preclinical program and facilitate study collaborations Cassava Sciences (NASDAQ: SAVA) ha nominato la Dott.ssa Angélique Bordey come Senior Vice President di Neuroscienze per guidare le attività di ricerca e sviluppo dell'azienda attualmente Vice Presidente del Dipartimento di Neurochirurgia presso la Yale School of Medicine manterrà il suo ruolo accademico part-time concentrandosi sulla valutazione di simufilam come possibile trattamento per l'epilessia correlata alla TSC e altre indicazioni in pipeline sono state fondamentali per il recente brevetto ottenuto da Cassava sull'uso di simufilam per trattare l'epilessia correlata alla TSC L'azienda ha stipulato un accordo di licenza con la Yale University per questo brevetto La sua esperienza nelle neuroscienze e il suo ruolo di leadership nella comunità TSC sono destinati a far progredire il programma preclinico di Cassava e a facilitare collaborazioni di studio Cassava Sciences (NASDAQ: SAVA) ha nombrado a la Dra Angélique Bordey como Vicepresidenta Senior de Neurociencia para liderar los esfuerzos de investigación y desarrollo de la empresa quien actualmente es Vicepresidenta del Departamento de Neurocirugía en la Yale School of Medicine mantendrá su puesto académico a tiempo parcial mientras se enfoca en evaluar simufilam como un posible tratamiento para la epilepsia relacionada con TSC y otras indicaciones en desarrollo fue fundamental para la reciente concesión de la patente de Cassava para el uso de simufilam en el tratamiento de la epilepsia relacionada con TSC La empresa ha asegurado un acuerdo de licencia con la Universidad de Yale para esta patente Su experiencia en neurociencia y liderazgo en la comunidad TSC se espera que impulsen el programa preclínico de Cassava y faciliten colaboraciones en estudios Cassava Sciences (NASDAQ: SAVA)는 회사의 연구 개발 노력을 이끌기 위해 앙겔리크 보르데이 박사를 신경과학 수석 부사장으로 임명했습니다 현재 예일 의과대학 신경외과 부학장으로 재직 중인 보르데이 박사는 파트타임으로 학계 직위를 유지하면서 simufilam을 TSC 관련 간질 및 기타 파이프라인 적응증의 잠재적 치료제로 평가하는 데 집중할 예정입니다 이는 Cassava가 최근 취득한 TSC 관련 간질 치료용 simufilam 특허에 핵심적인 역할을 했습니다 그녀의 신경과학 전문 지식과 TSC 커뮤니티에서의 리더십은 Cassava의 전임상 프로그램을 발전시키고 연구 협력을 촉진할 것으로 기대됩니다 Cassava Sciences (NASDAQ : SAVA) a nommé le Dr Angélique Bordey au poste de Vice-Présidente Senior des Neurosciences afin de diriger les efforts de recherche et développement de l'entreprise qui est actuellement Vice-Présidente du département de neurochirurgie à la Yale School of Medicine conservera son poste académique à temps partiel tout en se concentrant sur l'évaluation de simufilam comme traitement potentiel de l'épilepsie liée à la TSC et d'autres indications en développement ont été essentielles pour le brevet récemment accordé à Cassava concernant l'utilisation de simufilam pour traiter l'épilepsie liée à la TSC L'entreprise a conclu un accord de licence avec l'université de Yale pour ce brevet Son expertise en neurosciences et son rôle de leader dans la communauté TSC devraient faire progresser le programme préclinique de Cassava et faciliter les collaborations d'études Angélique Bordey zur Senior Vice President für Neurowissenschaften ernannt um die Forschungs- und Entwicklungsaktivitäten des Unternehmens zu leiten die derzeit stellvertretende Vorsitzende der Neurochirurgie an der Yale School of Medicine ist wird ihre akademische Position in Teilzeit beibehalten und sich darauf konzentrieren simufilam als potenzielle Behandlung für TSC-bedingte Epilepsie und weitere Pipeline-Indikationen zu evaluieren veröffentlicht in renommierten Fachzeitschriften war grundlegend für das kürzlich von Cassava erteilte Patent zur Verwendung von simufilam bei der Behandlung von TSC-bedingter Epilepsie Das Unternehmen hat eine Lizenzvereinbarung mit der Yale University für dieses Patent abgeschlossen Ihre Expertise in den Neurowissenschaften und ihre Führungsrolle in der TSC-Community sollen Cassavas präklinisches Programm vorantreiben und Studienkooperationen erleichtern Bordey will lead Cassava’s ongoing research and development efforts Bordey to direct the scientific evaluation of simufilam in TSC-related epilepsy and potentially additional pipeline indications 2025 (GLOBE NEWSWIRE) -- Cassava Sciences a clinical-stage biotechnology company focused on developing novel investigational treatments for central nervous system (CNS) disorders has joined the Company as Senior Vice President (SVP) while continuing her tenured academic position at Yale School of Medicine on a part time basis Bordey will be primarily responsible for leading Cassava’s research and development efforts Her scientific expertise will guide the Company’s preclinical program to evaluate simufilam as a potential treatment for TSC-related epilepsy and potentially for additional pipeline indications Bordey currently serves as the Vice Chair of the Department of Neurosurgery at Yale School of Medicine where she holds the Rothberg Endowed Chair She will limit the time devoted to those duties to allow her to perform her new role with Cassava Bordey’s unique neuroscience expertise can be instrumental to advancing our preclinical program and that her stature as a leader in the TSC community may allow for productive study collaborations,” said Rick Barry President and Chief Executive Officer of Cassava “Through my academic research and collaboration with the TSC Alliance I have learned that TSC-related epilepsy is among the more challenging epilepsy syndromes to manage often requiring innovative and individualized treatment approaches It is exciting to work directly with the Cassava team to advance the evaluation of simufilam as a potential novel treatment for this devasting rare disease I am hopeful that simufilam’s unique mechanism of action will provide a new approach to treating TSC-related epilepsy,” said Dr widely published neuroscientist and tenured professor who has dedicated her career to understanding neuronal signaling and unlocking the neurobiology of diseases such as tuberous sclerosis complex She has been a member of the Departments of Neurosurgery and Cellular and Molecular Physiology at Yale School of Medicine for more than two decades Department of Neurosurgery at Yale School of Medicine her work has resulted in more than 125 publications significant grant support and numerous invited lectures Bordey has mentored and supervised numerous students and postdoctoral associates overseen numerous grants and provided consulting advice to several biopharmaceutical companies Bordey earned her PhD in Neuroscience at University Louis Pasteur France and completed her post-doctoral fellowship at the University of Alabama at Birmingham she earned Master’s Degrees from the University Louis Pasteur in Neurophysiology and the Ecole Polytechnique de Lyon in Chemistry Bordey completed her Bachelor’s Degree in Mathematics and Chemistry at Blaise Pascal College and her Baccalaureate at Lycée Saint Joseph is a clinical-stage biotechnology company focused on developing novel for central nervous system disorders such as tuberous sclerosis complex (TSC)-related epilepsy investigational oral small molecule that targets the filamin A protein Cautionary Note Regarding Forward-Looking Statements:  This news release contains forward-looking statements that include but are not limited to statements regarding: our plans to conduct preclinical studies of simufilam relating to seizures in TSC the potential for simufilam as a treatment for TSC-related epilepsy and other indications and management appointments and comments made by our employees These statements may be identified by words such as “anticipate” and other words and terms of similar meaning All of our pharmaceutical assets under development are investigational product candidates They have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety have not been established in any patient population none of our product candidates is approved or available for sale anywhere in the world Our clinical results from earlier-stage clinical trials may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval You should not place undue reliance on these statements or any scientific data we present or publish We are in the business of new drug discovery Our research and development activities are long Holders of our common stock should carefully read our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q in their entirety Because risk is fundamental to the process of drug discovery you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested Already have an account? Login Family and friends of Jill Meredith Sava of East Windsor New Jersey are heartbroken to announce her passing on February 4 2025 at the age of forty-eight after battling several years with chronic illness Jill graduated college with a Bachelor’s in Jewish Studies with honors from Rutgers College and continued for a Masters in Jewish Communal Service from Hebrew Union College in Los Angeles She worked for many years at several JCC’s and Synagogues as the Director of Early Childhood Education She loved not only working with children but found great pride in helping her local Jewish communities flourish eleven years ago Jill developed a debilitating illness causing her to move home and give up on her dream career acknowledged that she was bedridden and said Jill would go on to spend the next eleven years of her life within the romance book community helping countless authors She didn’t take her diagnosis sitting down She is the epitome of what we should all do when facing darkness—fight to see the light and the most beautiful part of her newfound career was that she knew she had to sit—so others could run and she cheered each and every one of the people she worked with on until she quite literally could no longer speak She would engage in conversations where she had to mute her zoom calls because a nurse was attending to her She will always be remembered as someone who fought until the last breath of air left her lungs Jill advocated for others and started an incredible group on Facebook for those also dealing with Chronic illness—her legacy will never be forgotten Robin Smolarz (Gabriel) 12 nieces and nephews and two great nephews who will miss her greatly Memorial contributions can be made to The Gastroparesis Patient Association or the Mast Cell Disease Society Funeral services and burial were held February 7 Funeral arrangements are by Orland’s Ewing Memorial Chapel. For condolences please visit OrlandsMemorialChapel.com/Jill-Sava I knew Jill for several years through Author Rachel Van Dyken and through the Facebook group she made for chronic illnesses I am so sorry for her passing and pray for comforting peace for her family for the hours and days to come She was such an asset to our JCC in Allentown Sending love and support to the entire family Jill was such an amazing soul the book world is going to miss her so much I knew both Jill and her sister Robin as I was a member of Carousel Club which is a recreational program for those with disabilities that was started by the JCC of the Delaware Valley in conjunction with Mercer County now a program of The Arc Mercer and Jill was very nice to all of the members of Carousel including myself She will be sadly missed and Jill my former girlfriend Tammy A My deepest condolences to the family and friends of a brave woman Sorry for your loss 🙏 sending lots of love from Ireland My prayers and thoughts are with you at this time I did not know her but she sounds like a wonderful and amazing person Most of us know how it feels to lose someone we love And cherished memories never fade because a loved one is gone They will be with us forever in our hearts I was a member of the book community for some time and had interacted with Jill in relation to books but it wasn’t until I was diagnosed with gastroparesis that I became aware of her conditions I was afraid and felt alone with a scary diagnosis that changed my life drastically and that was difficult for my loved ones to understand Finding someone within the community I was already a part of who understood and who had made major adjustments to their life that resulted in being as busy and purposeful in chronic illness as they had been previously was an unbelievable inspiration to me Over the last couple of years I have not been able to be online as much as I could before but I always knew Jill and the group she had made for others with chronic illness was there for me if I needed them I hope it is a comfort to Jill’s family to know just how far and wide Jill made an impact When my daughter was in Israel last year she offered me support and someone to listen to my worries even though she didn’t really know me as we met through the book world I’m grateful for her kindness and wish her family my deepest sympathies May you be pain free and your memory always be a blessing My deepest condolences to her family and friends at this time of loss May you find the strength to move on and always remember her Δdocument.getElementById( "ak_js_1" ).setAttribute( "value" On the occasion of the 850th anniversary of Saint Sava’s birth the Patriarch Porfirije of Serbia celebrated a Hierarchical Divine Liturgy on May 2 at the Church of Saint Sava in Deževa —the very place where Stefan Nemanja laid the foundations of the first Serbian state and where his palace and cathedral once stood Concelebrating with Patriarch Porfirije were Metropolitans Teodosije of Raška-Prizren and Ignatije of Požarevac-Braničevo along with priests and monks from numerous dioceses of the Serbian Orthodox Church Many faithful from all regions of Raška participated prayerfully in the celebration the Patriarch emphasized: “Saint Sava was born here 850 years ago; it is his anniversary — and ours as well He journeyed to every corner of the world — as far as Egypt and to the West — building bridges of friendship and forging brotherly relations with all he showed that love is the true meaning of our existence and that and in the Crucifixion of Christ lies His victory.” He continued: “Saint Sava was born here you who come from this land should be proud because all of us — all Orthodox Serbs — were born here That is why we have come to you as true brothers and sisters: to be strengthened by your love and faith that the Lord may grant us all peace and joy wherever it may be — that we may all be one visited the Church of the Holy Apostles Peter and Paul — also known as the Petrova Church — in the Ras region near Novi Pazar where he sanctified and laid the cornerstone for a new monastic residence the Patriarch venerated the holy relics in the oldest church of the region the Patriarchate of Jerusalem solemnly celebrated the Sunday of the Myrrh-Bearing Women... Archbishop Elpidophoros of America celebrated the Divine Liturgy at the Monastery of the Theotokos.. it was announced that two Roman Catholic institutions in Bavaria have decided to jointly.. A car once used by Pope Francis during his 2014 visit to Bethlehem is being transformed into a mobile.. the Monastery of Saint Vlash in Albania hosted a festal Divine Liturgy on the.. Archbishop Ieronymos of Athens and All Greece presided over the festal Great Vespers at the historic.. (function() { window.mc4wp = window.mc4wp || { listeners: [] cb) { window.mc4wp.listeners.push( { event : evt callback: cb } ); } } }})(); © 2023 OrthodoxTimes.com - All rights reserved Necessary cookies are absolutely essential for the website to function properly This category only includes cookies that ensures basic functionalities and security features of the website These cookies do not store any personal information Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics other embedded contents are termed as non-necessary cookies It is mandatory to procure user consent prior to running these cookies on your website to their team as Senior Vice President of Neuroscience Her role within the company will run concurrently with her academic responsibilities at Yale School of Medicine where she holds a part-time tenured position Based on the consensus recommendation from 2 brokerage firms, Cassava Sciences Inc's (SAVA, Financial) average brokerage recommendation is currently 3.0 Africa Specialty Risks (ASR) has entered into binding authority agreements with Sava Re enabling the Slovenian reinsurance group to provide capacity across ASR’s core lines of business Each agreement includes a line size of up to US$10 million effective for risks incepting from March 20 is one of the largest reinsurers based in southeastern Europe The company serves over 450 partners across more than 100 reinsurance markets Get the latest reinsurance news direct to your inbox twice a week. Sign up here It holds “A”-level long-term financial strength ratings from S&P Global Ratings The agreement gives Sava Re expanded access to risks originating in Africa ASR said the partnership aligns with its objective to support economic development in growth economies by providing capacity where insurance coverage remains limited said that Sava Re has demonstrated strong risk and capital management and brings leading capacity to the partnership Since commencing underwriting in February 2021 ASR has aimed to close the insurance gap in these regions by offering a range of products including political risk & trade credit ASR also entered into Binding Authority Agreements with Eureka Re Eureka Re provides up to US$10 million in line size across various classes including political violence and terrorism In the same month, ASR Middle East also began operating as a Lloyd's service company in Dubai underwriting business on behalf of ASR Syndicate 2454 Please feel free to share your comments below Get the latest reinsurance news direct to your inbox twice a week. Sign up here Cassava Sciences (NASDAQ: SAVA) announced key leadership changes in its clinical development team after completing the company's Alzheimer's disease clinical trial program Jack Moore has been appointed as Senior Vice President of Clinical Development Moore will focus on advancing the clinical evaluation of simufilam for new potential indications including tuberous sclerosis complex (TSC)-related epilepsy He brings extensive experience in medical affairs and clinical development from leading global pharmaceutical companies Cassava Sciences (NASDAQ: SAVA) ha annunciato importanti cambiamenti nella sua squadra di sviluppo clinico andrà in pensione a partire dal 9 maggio 2025 dopo aver completato il programma di studi clinici sull'Alzheimer dell'azienda Jack Moore è stato nominato Senior Vice President dello Sviluppo Clinico Moore si concentrerà sull'avanzamento della valutazione clinica di simufilam per nuove potenziali indicazioni tra cui l'epilessia correlata alla sclerosi tuberosa (TSC) Porta con sé una vasta esperienza in affari medici e sviluppo clinico maturata in importanti aziende farmaceutiche globali soprattutto nel campo dei disturbi del sistema nervoso centrale Cassava Sciences (NASDAQ: SAVA) anunció cambios clave en su equipo de desarrollo clínico se retirará a partir del 9 de mayo de 2025 tras completar el programa de ensayos clínicos de la empresa sobre la enfermedad de Alzheimer Jack Moore ha sido nombrado Vicepresidente Senior de Desarrollo Clínico Moore se centrará en avanzar en la evaluación clínica de simufilam para nuevas indicaciones potenciales incluyendo la epilepsia relacionada con el complejo de esclerosis tuberosa (TSC) Aporta una amplia experiencia en asuntos médicos y desarrollo clínico adquirida en compañías farmacéuticas globales líderes especialmente en trastornos del sistema nervioso central Cassava Sciences (NASDAQ: SAVA)는 임상 개발 팀의 주요 리더십 변화를 발표했습니다 쿠피에크 박사(Chief Medical Officer)는 2025년 5월 9일부로 은퇴할 예정이며 잭 무어 박사가 2025년 4월 28일부로 임상 개발 수석 부사장으로 임명되었습니다 무어 박사는 결절성 경화증(TSC) 관련 간질을 포함한 새로운 적응증에 대한 시무필람의 임상 평가를 진전시키는 데 주력할 것입니다 그는 중추신경계 질환 분야를 중심으로 세계적인 제약사에서 의학 업무 및 임상 개발 경험을 풍부하게 쌓아왔습니다 Cassava Sciences (NASDAQ: SAVA) a annoncé des changements clés dans son équipe de développement clinique prendra sa retraite à compter du 9 mai 2025 après avoir terminé le programme d'essais cliniques de la société sur la maladie d'Alzheimer Le Dr Jack Moore a été nommé Senior Vice President du développement clinique Le Dr Moore se concentrera sur l'avancement de l'évaluation clinique de simufilam pour de nouvelles indications potentielles y compris l'épilepsie liée au complexe de sclérose tubéreuse (TSC) Il apporte une vaste expérience en affaires médicales et développement clinique acquise dans des entreprises pharmaceutiques mondiales de premier plan notamment dans les troubles du système nerveux central Cassava Sciences (NASDAQ: SAVA) gab bedeutende Führungswechsel in seinem klinischen Entwicklungsteam bekannt nachdem er das klinische Studienprogramm des Unternehmens zur Alzheimer-Krankheit abgeschlossen hat Jack Moore wurde zum Senior Vice President für klinische Entwicklung ernannt die klinische Bewertung von simufilam für neue potenzielle Indikationen voranzutreiben einschließlich der epileptischen Erkrankungen im Zusammenhang mit dem tuberösen Sklerose-Komplex (TSC) Er bringt umfangreiche Erfahrung in medizinischen Angelegenheiten und klinischer Entwicklung aus führenden globalen Pharmaunternehmen mit insbesondere im Bereich der ZNS-Erkrankungen for central nervous system (CNS) disorders such as tuberous sclerosis complex (TSC)-related epilepsy “The entire Cassava team is grateful for Jim’s service as our Chief Medical Officer He is retiring after a notable career of exemplary work with exceptional expertise in Alzheimer’s disease drug development Thanks to Jim’s attention to patient care and his deep credibility in the scientific community Cassava completed a high-quality clinical trial program in Alzheimer’s disease that was carried out with respect for the dignity of patients and their caregivers We wish Jim a happy and fulfilling retirement,” said Rick Barry Moore joins Cassava as Senior Vice President He will be responsible for advancing the clinical evaluation of simufilam in new potential indications Moore will build on an established track record of working in leading global pharmaceutical companies to advance novel compounds for the treatment of CNS disorders “As we formulate our strategy going forward He brings broad medical affairs and clinical development expertise plus extensive experience working with study sites and patient advocacy groups These skills will be invaluable to Cassava as we take the next steps in our TSC program identify potential clinical collaborators and study sites and explore additional potential applications,” commented Mr “I am eager to contribute my clinical development expertise to Cassava’s emerging program for simufilam in TSC and other applications,” said Dr Jack Moore is an accomplished biopharmaceutical executive with extensive drug development expertise in CNS and neurodegenerative diseases including Alzheimer’s disease and other neuro-immunologic and oncologic disorders He has a history of building and executing clinical development strategies and publication plans as well as engaging with key opinion leaders and medical communities in established and rare clinical indications across multiple drug modalities Head of Global Medical Affairs at Alector Inc Moore held clinical and medical affairs leadership roles of increasing responsibility at global pharmaceutical companies including Janssen Pharmaceutica a subsidiary of Bristol-Myers Squibb Company Moore earned his Doctor of Philosophy in Neuroscience at the University of North Texas and he was a Post-Doctoral Research Fellow at the University of Texas at Southwestern Medical Center at Dallas He earned his Master of Science in Physiology at the University of North Texas and his Bachelor of Science in Biology at Texas State University Mediamedia@cassavasciences.com Cassava Sciences (NASDAQ: SAVA) reported its 2024 financial results highlighting key developments in its clinical programs The company expects top-line data from REFOCUS-ALZ its second Phase 3 study of simufilam in Alzheimer's disease This follows the November 2024 RETHINK-ALZ study which failed to meet its co-primary endpoints leading to the discontinuation of all Alzheimer's disease clinical studies The company ended 2024 with $128.6 million in cash and no debt Net loss decreased to $24.3 million ($0.53 per share) in 2024 from $97.2 million in 2023 R&D expenses decreased to $69.6 million from $89.4 million while G&A expenses increased to $71.8 million from $16.5 million primarily due to a $40 million SEC settlement Cassava has entered a new licensing agreement with Yale University to explore simufilam's potential in treating tuberous sclerosis complex (TSC)-related seizures The company projects $16-20 million in net cash use for H1 2025 Cassava Sciences (NASDAQ: SAVA) ha riportato i risultati finanziari del 2024 evidenziando sviluppi chiave nei suoi programmi clinici L'azienda prevede di ricevere i dati preliminari dallo studio REFOCUS-ALZ il suo secondo studio di Fase 3 su simufilam nella malattia di Alzheimer entro la fine del primo trimestre/primi del secondo trimestre del 2025 Questo segue lo studio RETHINK-ALZ di novembre 2024 che non ha raggiunto i suoi obiettivi co-principali portando alla sospensione di tutti gli studi clinici sulla malattia di Alzheimer L'azienda ha chiuso il 2024 con 128,6 milioni di dollari in contante e senza debiti La perdita netta è diminuita a 24,3 milioni di dollari (0,53 dollari per azione) nel 2024 rispetto ai 97,2 milioni di dollari nel 2023 Le spese per R&S sono diminuite a 69,6 milioni di dollari rispetto ai 89,4 milioni di dollari mentre le spese generali e amministrative sono aumentate a 71,8 milioni di dollari rispetto ai 16,5 milioni di dollari principalmente a causa di un accordo di 40 milioni di dollari con la SEC Cassava ha stipulato un nuovo accordo di licenza con l'Università di Yale per esplorare il potenziale di simufilam nel trattamento delle crisi correlate alla sclerosi tuberosa complessa (TSC) L'azienda prevede un utilizzo di cassa netto di 16-20 milioni di dollari per il primo semestre del 2025 Cassava Sciences (NASDAQ: SAVA) informó sus resultados financieros de 2024 destacando desarrollos clave en sus programas clínicos La compañía espera datos preliminares del estudio REFOCUS-ALZ su segundo estudio de Fase 3 de simufilam en la enfermedad de Alzheimer a finales del primer trimestre/principios del segundo trimestre de 2025 Esto sigue al estudio RETHINK-ALZ de noviembre de 2024 que no logró cumplir con sus objetivos co-principales lo que llevó a la suspensión de todos los estudios clínicos sobre la enfermedad de Alzheimer La compañía cerró 2024 con 128,6 millones de dólares en efectivo y sin deudas La pérdida neta disminuyó a 24,3 millones de dólares (0,53 dólares por acción) en 2024 desde 97,2 millones de dólares en 2023 Los gastos de I+D disminuyeron a 69,6 millones de dólares desde 89,4 millones de dólares mientras que los gastos generales y administrativos aumentaron a 71,8 millones de dólares desde 16,5 millones de dólares principalmente debido a un acuerdo de 40 millones de dólares con la SEC Cassava ha firmado un nuevo acuerdo de licencia con la Universidad de Yale para explorar el potencial de simufilam en el tratamiento de las convulsiones relacionadas con la esclerosis tuberosa compleja (TSC) La compañía proyecta un uso neto de efectivo de 16-20 millones de dólares para el primer semestre de 2025 카사바 사이언스 (NASDAQ: SAVA)는 2024년 재무 결과를 보고하며 임상 프로그램의 주요 개발 사항을 강조했습니다 회사는 알츠하이머병에 대한 시뮤필람의 두 번째 3상 연구인 REFOCUS-ALZ의 주요 데이터를 2025년 1분기 말 또는 2분기 초에 발표할 것으로 예상하고 있습니다 이는 2024년 11월에 실시된 RETHINK-ALZ 연구에 이어지는 것으로 이 연구는 공동 주요 목표를 달성하지 못해 모든 알츠하이머병 임상 연구가 중단되었습니다 2024년 순손실은 2023년 9억 7200만 달러에서 2430만 달러 (주당 0.53달러)로 감소했습니다 카사바는 예일대학교와 새로운 라이선스 계약을 체결하여 시뮤필람의 잠재력을 결절성 경화증(TSC) 관련 발작 치료에 대해 탐색하고 있습니다 회사는 2025년 상반기 동안 1600만~2000만 달러의 순 현금 사용을 예상하고 있습니다 Cassava Sciences (NASDAQ: SAVA) a annoncé ses résultats financiers pour 2024 mettant en avant des développements clés dans ses programmes cliniques La société s'attend à des données préliminaires de l'étude REFOCUS-ALZ sa deuxième étude de Phase 3 sur le simufilam dans la maladie d'Alzheimer d'ici la fin du premier trimestre/début du deuxième trimestre 2025 Cela fait suite à l'étude RETHINK-ALZ de novembre 2024 qui n'a pas atteint ses objectifs co-principaux entraînant l'arrêt de toutes les études cliniques sur la maladie d'Alzheimer La société a terminé 2024 avec 128,6 millions de dollars en liquidités et sans dettes La perte nette a diminué à 24,3 millions de dollars (0,53 dollar par action) en 2024 contre 97,2 millions de dollars en 2023 Les dépenses de R&D ont diminué à 69,6 millions de dollars contre 89,4 millions de dollars tandis que les dépenses générales et administratives ont augmenté à 71,8 millions de dollars contre 16,5 millions de dollars principalement en raison d'un règlement de 40 millions de dollars avec la SEC Cassava a conclu un nouvel accord de licence avec l'Université de Yale pour explorer le potentiel du simufilam dans le traitement des crises liées à la sclérose tubéreuse complexe (TSC) La société prévoit une utilisation nette de liquidités de 16 à 20 millions de dollars pour le premier semestre 2025 Cassava Sciences (NASDAQ: SAVA) hat ihre finanziellen Ergebnisse für 2024 veröffentlicht und wichtige Entwicklungen in ihren klinischen Programmen hervorgehoben Das Unternehmen erwartet die ersten Ergebnisse der REFOCUS-ALZ-Studie seiner zweiten Phase-3-Studie zu Simufilam bei Alzheimer Dies folgt auf die RETHINK-ALZ-Studie im November 2024 die ihre ko-prägnanten Endpunkte nicht erreicht hat was zur Einstellung aller klinischen Studien zur Alzheimer-Krankheit führte Das Unternehmen schloss das Jahr 2024 mit 128,6 Millionen Dollar in bar und ohne Schulden ab Der Nettoverlust verringerte sich auf 24,3 Millionen Dollar (0,53 Dollar pro Aktie) im Jahr 2024 verglichen mit 97,2 Millionen Dollar im Jahr 2023 Die F&E-Ausgaben sanken auf 69,6 Millionen Dollar von 89,4 Millionen Dollar während die allgemeinen und administrativen Ausgaben auf 71,8 Millionen Dollar von 16,5 Millionen Dollar stiegen hauptsächlich aufgrund eines 40-Millionen-Dollar-Vergleichs mit der SEC Cassava hat einen neuen Lizenzvertrag mit der Yale-Universität abgeschlossen um das Potenzial von Simufilam zur Behandlung von Anfällen im Zusammenhang mit tuberöser Sklerose (TSC) zu erkunden Das Unternehmen rechnet mit einem Nettobarmittelverbrauch von 16-20 Millionen Dollar für das erste Halbjahr 2025 Cassava's 2024 financial results highlight a company at a critical inflection point the immediate liquidity picture appears stable but the $116.9 million cash burn in 2024 indicates approximately one year of runway at current spending levels The projected $16-20 million cash use for H1 2025 signals substantial operational scaling back The reported net loss reduction to $24.3 million ($0.53 per share) from $97.2 million requires careful interpretation as it stems largely from non-operational warrant liability valuation changes rather than business improvements More telling is the 22% R&D expense reduction to $69.6 million reflecting the completed enrollment and subsequent discontinuation of Alzheimer's trials following RETHINK-ALZ's failure to meet endpoints The striking 335% increase in G&A expenses to $71.8 million was primarily driven by the $40 million SEC settlement a significant corporate governance concern The transition away from quarterly earnings calls to event-driven communications further suggests a company focusing resources on critical path activities while reducing regular investor touchpoints The pending REFOCUS-ALZ results and new Yale licensing agreement for TSC-related seizures represent the company's potential paths forward though investors should note the TSC program is still preclinical meaning significant development time and capital would be required before potential commercialization Cassava's clinical pipeline strategy is undergoing a fundamental restructuring following the November 2024 RETHINK-ALZ study failure The discontinuation of their Alzheimer's clinical program represents a significant setback for their lead asset simufilam with only the REFOCUS-ALZ readout remaining as a potential salvage opportunity in the Alzheimer's indication The Yale University licensing agreement for tuberous sclerosis complex (TSC)-related seizures introduces a strategic pivot toward a rare disease indication with potentially lower development costs and regulatory hurdles compared to Alzheimer's This represents a rational portfolio diversification given simufilam's mechanism targeting filamin A which has potential applications beyond Alzheimer's TSC affects approximately 1 in 6,000 births and is characterized by non-cancerous tumors in multiple organs with nearly 90% of patients experiencing seizures Current treatments provide inadequate seizure control in many patients creating a well-defined market opportunity with less competition than Alzheimer's The complete discontinuation of all Alzheimer's studies following the single RETHINK-ALZ failure indicates internal confidence in simufilam's Alzheimer's efficacy This decisive action suggests the company is preparing for a full strategic repositioning around TSC and potentially other neurological indications where filamin A modulation may prove more effective including Alzheimer’s disease and tuberous sclerosis complex (TSC)-related seizures today reported financial results for the year ended December 31 “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 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 Professor of Neurosurgery and Vice Chair of Research 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 REFOCUS-ALZ (NCT05026177) is a Phase 3 trial designed as a multi-center 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. 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 orally twice daily (BID) for 76 weeks 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 76-week data Topline data for the study are anticipated in late first-quarter/early second-quarter 2025 The prespecified 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 76 assessed by the ADAS-COG12 and ADCS-ADL scales comparing each dose of 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 an evaluation of changes in plasma and cerebrospinal fluid biomarkers from baseline to week 76 as well as an evaluation of various brain volumes using magnetic resonance imaging (MRI) and amyloid and tau deposition using positron emission tomography (PET) scans from baseline to week 76 RETHINK-ALZ (NCT04994483) is a Phase 3 trial designed to evaluate the safety and efficacy of simufilam in a multi-center randomized parallel group study involving over 75 clinical trial sites in the U.S. 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 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 The prespecified 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 The study also included a pharmacokinetic and plasma biomarker sub-study comprised of approximately 100 subjects the Company reported that the RETHINK-ALZ study did not meet the prespecified co-primary endpoints The Company also indicated that it planned to continue to review the data and evaluate next steps and that it intended to share the data at a future medical meeting Tuberous sclerosis complex (TSC) and focal cortical dysplasia (FCD) type II are neurodevelopmental disorders caused by mutations in mechanistic target of rapamycin (mTOR) pathway genes These mutations lead to focal malformations of the developing cortex and seizures in 80% to 90% of patients Nearly two-thirds of TSC patients do not respond to antiepileptic drugs and experience lifelong seizures leading to a spectrum of neurocognitive and psychological disabilities and poor quality of life are associated with serious adverse events and/or are invasive.1 Cassava will focus on TSC-related seizures the disorder affects an estimated 1 in 6,000 live births Approximately 50,000 people in the United States and more than one million worldwide live with TSC2 1. Science Translational Medicine. 2020 Feb 19: https://pubmed.ncbi.nlm.nih.gov/32075941/   2. https://www.tscalliance.org/understanding-tsc/what-is-tsc/ investigational treatments for central nervous system disorders For more information, please visit: https://www.CassavaSciences.com InvestorsSandya von der Weidsvonderweid@lifesciadvisors.com Mediamedia@cassavasciences.com Cautionary Note Regarding Forward-Looking Statements: This news release contains forward-looking statements that include but are not limited to statements regarding: our intention to share topline data from REFOCUS-ALZ the timing of data from the REFOCUS-ALZ study the timing to evaluate the data from REFOCUS-ALZ and RETHINK-ALZ our plans to share the data from one or both studies our plans to conduct preclinical studies of simufilam relating to seizures in TSC and other neurodevelopmental disorders the potential for simufilam as a treatment for TSC-related seizures These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety 100%; border-collapse:collapse ;">  CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited except per share amounts)          Three months ended December 31 net 90   291   411   907 Gain from change in fair value of warrant liabilities —   —   108,183   — Net loss$(27,597) $(20,919) $(24,342) $(97,217)            Net loss per share basic$(0.57) $(0.50) $(0.53) $(2.32)Net loss per share diluted (0.57)  (0.50)  (1.46)  (2.32)            Weighted-average shares used in computing net loss per share basic 48,099   42,188   46,329   41,932 Weighted-average shares used in computing net loss per share diluted 48,099   42,188   46,604   41,932              CONDENSED CONSOLIDATED BALANCE SHEETS(unaudited in thousands)       Year Ended December 31       2024  2023 Assets           Current assets           Cash and cash equivalents      $128,574  $121,136 Prepaid expenses and other current assets       7,958   8,497 Total current assets       136,532   129,633 Property and equipment net       20,964   21,854 Intangible assets Cassava Sciences (NASDAQ: SAVA) has secured a license agreement with Yale University for intellectual property rights including an exclusive license to a US method of treatment patent for simufilam as a potential treatment for seizures related to rare neurodevelopmental disorders particularly tuberous sclerosis complex (TSC) The licensed patent stems from research led by Dr published in Science Translational Medicine in 2020 Cassava's proprietary small molecule drug candidate targeting filamin A showed promising results in reducing TSC-related seizure frequency in animal models The company plans to conduct preclinical studies in collaboration with the TSC Alliance to evaluate simufilam's potential as a treatment for TSC-related seizures and determine future development steps Cassava Sciences (NASDAQ: SAVA) ha ottenuto un accordo di licenza con l'Università di Yale per i diritti di proprietà intellettuale inclusa una licenza esclusiva per un brevetto statunitense relativo a un metodo di trattamento per simufilam considerato un potenziale trattamento per le crisi epilettiche legate a disturbi neuroevolutivi rari in particolare il complesso di sclerosi tuberosa (TSC) Il brevetto licenziato deriva da ricerche condotte dalla Dr.ssa Angélique Bordey presso Yale pubblicate in Science Translational Medicine nel 2020 il candidato farmaco di piccole molecole proprietario di Cassava ha mostrato risultati promettenti nella riduzione della frequenza delle crisi legate al TSC in modelli animali L'azienda prevede di condurre studi preclinici in collaborazione con l'alleanza TSC per valutare il potenziale di simufilam come trattamento per le crisi legate al TSC e determinare i futuri passi di sviluppo Cassava Sciences (NASDAQ: SAVA) ha asegurado un acuerdo de licencia con la Universidad de Yale para los derechos de propiedad intelectual incluida una licencia exclusiva para una patente de método de tratamiento en EE para simufilam como un posible tratamiento para las convulsiones relacionadas con trastornos neurodesarrollo raros particularmente el complejo de esclerosis tuberosa (TSC) La patente licenciada proviene de una investigación liderada por la Dra publicada en Science Translational Medicine en 2020 el candidato a fármaco de pequeñas moléculas propietario de Cassava mostró resultados prometedores en la reducción de la frecuencia de convulsiones relacionadas con el TSC en modelos animales La empresa planea llevar a cabo estudios preclínicos en colaboración con la Alianza TSC para evaluar el potencial de simufilam como tratamiento para las convulsiones relacionadas con el TSC y determinar los pasos de desarrollo futuros 카사바 사이언스(Cassava Sciences) (NASDAQ: SAVA)는 예일 대학교와 지적 재산권에 대한 라이센스 계약을 체결했으며 여기에는 시무필람(simufilam)에 대한 미국 치료 방법 특허에 대한 독점 라이센스가 포함됩니다 특히 결절성 경화증 복합체(TSC)에 대한 잠재적 치료제로 고려되고 있습니다 라이센스된 특허는 예일 대학교의 앙젤리크 보르데이 박사가 주도한 연구에서 비롯되었으며 2020년 Science Translational Medicine에 발표되었습니다 이 연구는 카사바의 독점 소분자 약물 후보인 시무필람이 필라민 A를 표적으로 하여 TSC와 관련된 발작 빈도를 동물 모델에서 줄이는 데 유망한 결과를 보였음을 보여주었습니다 회사는 TSC 연합과 협력하여 시무필람의 TSC 관련 발작 치료 가능성을 평가하고 향후 개발 단계를 결정하기 위한 전임상 연구를 수행할 계획입니다 Cassava Sciences (NASDAQ: SAVA) a conclu un accord de licence avec l'Université de Yale pour les droits de propriété intellectuelle y compris une licence exclusive pour un brevet américain relatif à une méthode de traitement pour simufilam considéré comme un traitement potentiel pour les crises liées à des troubles neurodéveloppementaux rares en particulier le complexe de sclérose tubéreuse (TSC) Le brevet sous licence provient de recherches menées par la Dr Angélique Bordey à Yale publiées dans Science Translational Medicine en 2020 le candidat médicament à petites molécules propriétaire de Cassava a montré des résultats prometteurs dans la réduction de la fréquence des crises liées au TSC dans des modèles animaux L'entreprise prévoit de réaliser des études précliniques en collaboration avec l'Alliance TSC pour évaluer le potentiel de simufilam en tant que traitement des crises liées au TSC et déterminer les étapes de développement futures Cassava Sciences (NASDAQ: SAVA) hat eine Lizenzvereinbarung mit der Yale-Universität über geistige Eigentumsrechte abgeschlossen einschließlich einer exklusiven Lizenz für ein US-Patent für eine Behandlungsmethode für simufilam als potenzielle Behandlung von Anfällen im Zusammenhang mit seltenen neurodevelopmentalen Störungen insbesondere dem tuberösen Sklerosekomplex (TSC) Das lizenzierte Patent stammt aus einer Forschung Angélique Bordey an Yale geleitet wurde und 2020 in Science Translational Medicine veröffentlicht wurde vielversprechende Ergebnisse bei der Reduzierung der Anfallshäufigkeit im Zusammenhang mit TSC in Tiermodellen zeigte in Zusammenarbeit mit der TSC-Allianz präklinische Studien durchzuführen um das Potenzial von simufilam als Behandlung für TSC-bezogene Anfälle zu bewerten und zukünftige Entwicklungsschritte zu bestimmen Cassava Sciences' licensing agreement with Yale University marks a strategic expansion of its simufilam development program beyond Alzheimer's disease into rare neurodevelopmental disorders specifically targeting seizures related to tuberous sclerosis complex (TSC) This diversification is particularly significant given Cassava's recent challenges in their Alzheimer's program which has faced skepticism and controversy With a market cap of just $116.4 million and share price of $2.30 the company desperately needs to broaden simufilam's potential applications to create additional value pathways The Science Translational Medicine publication provides scientific credibility that has been questioned in Cassava's Alzheimer's program Working with the TSC Alliance also adds legitimacy and access to patient networks for future clinical trials this creates a potential secondary value driver while reducing overall program risk through indication diversification requiring substantial preclinical work before potential clinical trials The company's cash resources (~$30 million estimated) mean they'll likely need additional financing to pursue this indication alongside their ongoing Alzheimer's program 2025 (GLOBE NEWSWIRE) --  Cassava Sciences today announced that it has entered into an agreement with Yale University (Yale) for a license to intellectual property rights including an exclusive license to an issued US method of treatment patent (US 12,186,3071) for simufilam as a potential treatment for seizures related to rare neurodevelopmental disorders including tuberous sclerosis complex (TSC) Simufilam is Cassava’s proprietary small molecule drug candidate that targets filamin A The intellectual property that Cassava has licensed is based on the promising research and development work of Angélique Bordey In a paper published in Science Translational Medicine2 in 2020 the researchers showed that treatment with simufilam (also known as PTI-125) appeared to meaningfully reduce TSC-related seizure frequency in an animal model These data formed the basis of the US method of treatment patent issued to Yale on January 7 which is included in the license to Cassava “We are pleased to enter into a license agreement with Yale University Bordey’s research opens the door to a potential new therapeutic application for simufilam in the treatment of seizures related to rare neurodevelopmental disorders including tuberous sclerosis complex,” said Rick Barry President and Chief Executive Officer of Cassava Sciences “We plan to conduct preclinical studies in collaboration with the TSC Alliance to further evaluate simufilam’s potential as a treatment for TSC-related seizures and define next steps.” Tuberous sclerosis complex (TSC) and focal cortical dysplasia (FCD) type II are neurodevelopmental disorders caused by mutations in the mechanistic target of rapamycin (mTOR) pathway genes are associated with serious adverse events and/or are invasive.2 Cassava will focus on developing simufilam as a potential treatment for TSC-related seizures Approximately 50,000 people in the United States and more than one million worldwide live with TSC3 1.   US Patent 12,186,307 B2 2.   Science Translational Medicine. 2020 Feb 19: https://pubmed.ncbi.nlm.nih.gov/32075941/   3.   https://www.tscalliance.org/understanding-tsc/what-is-tsc/ For more information, please visit: https://www.CassavaSciences.com InvestorsSandya van der Weidsvonderweid@lifesciadvisors.com Mediamedia@cassavasciences.com Cautionary Note Regarding Forward-Looking Statements:This news release contains forward-looking statements that include but are not limited to statements regarding: the plan to conduct preclinical studies of simufilam relating to TSC-related epilepsy opportunities for simufilam with respect to other neurodevelopmental disorders the potential for simufilam as a treatment for TSC-related seizures and Cassava’s development priorities Our clinical results from preclinical studies and earlier-stage clinical trials may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval “The closest comparison might be a full-body head tingler I won’t lie to you: when an opportunity to elevate my consciousness by way of a vibrating sound pod crossed my inbox the invitation raised more suspicion than awareness I am generally apprehensive of the ways in which the tech industry dove-tails with the wellness sector — the careless repackaging of indigenous traditions the personal solutions to systemic problems the capitalistic leap-frog game between buzzy new ailments and their quick cures — and truthfully Very little in wellness could surprise me; did I really need another hunk of rose quartz and permission to be more selfish That being said, we’re in deeply unwell times. I’m not immune to the allure of serenity — especially when a machine does the inner work for you. The mysterious and futuristic-sounding SAVA Sound Pod promised “a multi-dimensional healing journey” in a contraption described in deliciously infantilizing verbiage like “womblike and welcoming,” and “built like a cradle ideal for healing and ergonomic benefits.” It was low-lift enlightenment: “simply choose a Sound Journey despite not really understanding what SAVA was — a product I had to leave the house anyway: it was free Slurpee day at 7-Eleven with or without THC — to ensure an accurate write-up and avoid Pod paranoia I opted for the latter — and led into a gallery drenched in cosmic swirling light the Pod: a slick black lounger encircled with a rope of blue neon and topped with buttery fabric pulled taught so that when you lie across it Beneath the fabric were ten 100-watt bass amplifiers and an arrangement of strategically placed speakers music becomes a sonic and physical experience that “hypnotizes the body,” as Kelly put it Every detail of the Pod had been engineered to reduce stress from its airy open-top design to winged sides that “hug” the body activating touchpoints that signal safety to the human nervous system Kelly demonstrated how to get in the Pod — you sit at the foot of it swaddled me in a weighted blanket and sleep mask finally understanding all those womb comparisons and trippy synth resonated through my body I’ve been to those 4DX movies where they shake the chair and spritz you with mist and I’d left damp and nauseated; this experience had the same immersive spirit I was a baby in a bassinet; I was a battery in a Hitachi wand; I was going to leave this experience taller After the last beat reverberated through my skull I hadn’t traversed time or hopped dimensions And then I realized: I was feeling a lack of tension always-in-its-TMJ-era jaw — was unclenched it’s an achievement to spend an hour doing something ineffable I don’t know exactly how to explain the SAVA Pod The closest comparison might be a full-body head tingler Kelly noted that perhaps the Pod isn’t meant to be fully quantified with language: “While we are seeing an incredible shift in science-based research driving holistic healthcare it’s really important to balance our foundational research with more progressive ideas that look at the magic in the unknown.. We have so much more to learn and give in our understanding of ourselves and the deeply synergistic relationship we have with nature and the universe with multi-Pod healing centers in different locations around the country to follow Maybe my heart had softened and my mind had been pried open with theta waves I do believe that Kelly wants to heal the world I can’t fully dunk on the Pod — I can only hope that one day its womblike embrace is available to everyone no doubt exhausted from the parade of free Slurpee grifters nonetheless greeted me with the warmth of a friend A stranger complimented the way I dispensed Slurpee into my cup “Have a good one!” Like I was the main character in a neighborhood sitcom everyone in my orbit was disconcertingly happy to see me The only logical conclusion: my vibes had been made immaculate You need to first accept the terms and conditions before download Subject to the Terms of usage of UN Photo UN Photo materials are available free of charge for news purposes only UN Photo materials may not be sold or redistributed to third parties without the prior written consent of the UN or the UN entity which is source of the UN Photo material All users of UN Photo materials must provide due credit to the United Nations or any UN entity source(s) in their use and broadcast of UN Photo materials Cassava Sciences (NASDAQ: SAVA) announced that its Phase 3 REFOCUS-ALZ study of simufilam for mild-to-moderate Alzheimer's disease failed to meet its primary endpoints showed no significant reduction in cognitive or functional decline compared to placebo over 76 weeks following similar negative results from another Phase 3 trial While simufilam demonstrated a favorable safety profile Cassava will completely discontinue its Alzheimer's disease development program by Q2 2025 The company plans to redirect efforts toward evaluating simufilam for TSC-related epilepsy in preclinical studies Cassava maintains a strong financial position with approximately $128.6 million in cash and cash equivalents Cassava Sciences (NASDAQ: SAVA) ha annunciato che il suo studio di Fase 3 REFOCUS-ALZ su simufilam per la malattia di Alzheimer da lieve a moderata non ha raggiunto i suoi obiettivi principali non ha mostrato una riduzione significativa del declino cognitivo o funzionale rispetto al placebo nel corso di 76 settimane Lo studio è stato interrotto il 25 novembre 2024 dopo risultati negativi simili provenienti da un altro studio di Fase 3 Sebbene simufilam abbia dimostrato un profilo di sicurezza favorevole Cassava interromperà completamente il suo programma di sviluppo per la malattia di Alzheimer entro il secondo trimestre del 2025 L'azienda prevede di reindirizzare gli sforzi verso la valutazione di simufilam per l'epilessia correlata alla TSC in studi preclinici Cassava mantiene una solida posizione finanziaria con circa $128,6 milioni in contante e equivalenti di cassa Cassava Sciences (NASDAQ: SAVA) anunció que su estudio de Fase 3 REFOCUS-ALZ sobre simufilam para la enfermedad de Alzheimer leve a moderada no logró cumplir con sus objetivos principales no mostró una reducción significativa en el deterioro cognitivo o funcional en comparación con el placebo durante 76 semanas El estudio fue interrumpido el 25 de noviembre de 2024 tras resultados negativos similares de otro ensayo de Fase 3 Si bien simufilam demostró un perfil de seguridad favorable Cassava cancelará por completo su programa de desarrollo para la enfermedad de Alzheimer para el segundo trimestre de 2025 La empresa planea redirigir sus esfuerzos hacia la evaluación de simufilam para la epilepsia relacionada con TSC en estudios preclínicos Cassava mantiene una sólida posición financiera con aproximadamente $128.6 millones en efectivo y equivalentes de efectivo 카사바 사이언스 (NASDAQ: SAVA)는 경증에서 중등도의 알츠하이머병에 대한 시무필람의 3상 REFOCUS-ALZ 연구가 주요 목표를 달성하지 못했다고 발표했습니다 1,125명의 환자가 참여한 이 시험은 76주 동안 위약에 비해 인지적 또는 기능적 감소의 유의미한 감소를 보여주지 않았습니다 또 다른 3상 시험인 RETHINK-ALZ에서도 유사한 부정적인 결과가 나왔습니다 카사바는 2025년 2분기까지 알츠하이머병 개발 프로그램을 완전히 중단할 예정입니다 회사는 시무필람을 TSC 관련 간질에 대한 전임상 연구로 평가하는 방향으로 노력을 전환할 계획입니다 2024년 12월 31일 현재 카사바는 약 $128.6 백만의 현금 및 현금 등가물을 보유하고 있어 재정적으로 안정적인 상태를 유지하고 있습니다 Cassava Sciences (NASDAQ: SAVA) a annoncé que son étude de Phase 3 REFOCUS-ALZ sur le simufilam pour la maladie d'Alzheimer légère à modérée n'a pas atteint ses objectifs principaux n'a montré aucune réduction significative du déclin cognitif ou fonctionnel par rapport au placebo sur une période de 76 semaines L'étude a été interrompue le 25 novembre 2024 suite à des résultats négatifs similaires d'un autre essai de Phase 3 Bien que le simufilam ait démontré un profil de sécurité favorable Cassava mettra complètement fin à son programme de développement pour la maladie d'Alzheimer d'ici le deuxième trimestre 2025 L'entreprise prévoit de rediriger ses efforts vers l'évaluation du simufilam pour l'épilepsie liée à la TSC dans des études précliniques Cassava maintient une solide position financière avec environ 128,6 millions de dollars en liquidités et équivalents de liquidités Cassava Sciences (NASDAQ: SAVA) gab bekannt dass die Phase-3-Studie REFOCUS-ALZ zu Simufilam bei leichter bis mäßiger Alzheimer-Krankheit ihre primären Endpunkte nicht erreicht hat zeigte über einen Zeitraum von 76 Wochen keine signifikante Reduktion des kognitiven oder funktionalen Rückgangs im Vergleich zur Placebo-Gruppe nachdem ähnliche negative Ergebnisse aus einer anderen Phase-3-Studie Obwohl Simufilam ein günstiges Sicherheitsprofil aufwies wird Cassava sein Entwicklungsprogramm für Alzheimer bis zum zweiten Quartal 2025 vollständig einstellen seine Anstrengungen auf die Bewertung von Simufilam bei TSC-bedingter Epilepsie in präklinischen Studien umzuleiten Dezember 2024 verfügt Cassava über eine starke finanzielle Position mit etwa $128,6 Millionen in bar und liquiden Mitteln The Phase 3 REFOCUS-ALZ trial results represent a decisive clinical failure for Cassava Sciences' lead candidate simufilam in Alzheimer's disease the drug failed to meet all prespecified co-primary secondary and exploratory biomarker endpoints showing no significant benefits over placebo in cognitive or functional measures after 76 weeks of treatment following the earlier RETHINK-ALZ study disappointment effectively terminates simufilam's development pathway in Alzheimer's The company's explicit decision to "discontinue all efforts" in this indication by Q2 2025 signals a complete abandonment of what was clearly their flagship program The clinical development setback is particularly significant because: safety without efficacy offers no developmental pathway The company's pivot to TSC-related epilepsy keeps the asset alive but resets their clinical timeline dramatically moving from near-market potential to years of preclinical and early clinical work with uncertain prospects This Phase 3 failure fundamentally alters Cassava's investment profile and near-term prospects The discontinuation of their Alzheimer's program eliminates what was likely their primary value driver and most advanced pipeline asset While the company reports $128.6 million in cash as of December 31 the strategic pivot has significant financial implications: This represents a material business transformation from a late-stage Alzheimer's-focused company to one with primarily preclinical assets The unambiguous nature of both Phase 3 failures (REFOCUS-ALZ and RETHINK-ALZ) leaves no pathway to salvage the significant investment already made in the Alzheimer's program The TSC-epilepsy indication represents a much smaller potential market than Alzheimer's disease further affecting the company's long-term revenue prospects Investors should anticipate a fundamental reassessment of the company's valuation framework based on this significant pipeline setback a clinical-stage biotechnology company focused on developing a novel investigational treatment for central nervous system disorders including Alzheimer’s disease (AD) dementia and tuberous sclerosis complex (TSC)-related epilepsy today shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate AD Topline data indicate that REFOCUS-ALZ did not meet each of the prespecified co-primary The co-primary endpoints were the change in cognition and function from baseline to the end of the double-blind treatment period at week 76 REFOCUS-ALZ enrolled 1,125 patients and was discontinued on November 25 following the report that a prior 52-week Phase 3 study A large portion of subjects enrolled in REFOCUS-ALZ completed their final study visit prior to the termination of the trial Simufilam continued to demonstrate an overall favorable safety profile “We are disappointed that the results of REFOCUS-ALZ and RETHINK-ALZ showed no treatment benefit for patients with mild-to-moderate Alzheimer’s disease their families and their caregivers has brought a special dignity to our Phase 3 Alzheimer’s disease clinical trial program and to each of us at Cassava We are deeply grateful for the dedication and committed efforts of study investigators and site teams who enabled us to conduct these trials with integrity and scientific rigor and whose efforts provided a clear data read out,” said Rick Barry “Cassava will discontinue all efforts to develop simufilam for Alzheimer’s disease and we expect to phase out the program by the end of Q2 2025,” continued Mr “We remain dedicated to our mission of developing novel medicines for central nervous system disorders While we have initiated preclinical studies to evaluate simufilam’s potential as a treatment for TSC-related epilepsy we maintain ongoing strategic expense management efforts.” Chief Financial Officer of Cassava commented “We remain focused on the interests of Cassava shareholders and are committed to enhancing shareholder value Cassava is well-capitalized with approximately $128.6 million in cash and cash equivalents as of December 31 Summary Study Results: Primary Endpoint Data The table below provides a high-level summary of the patient demographic and safety data in years73.6 ± 8.274.5 ± 7.673.7 ± 7.9Sex including P-tau217 (phosphorylated tau at threonine 217) GFAP (glial fibrillary acidic protein) and NFL (neurofilament light chain) as well as an evaluation of various brain volumes using MRI (magnetic resonance imaging) and amyloid and tau deposition using PET (positron emission tomography) scans from baseline to week 76 including Alzheimer’s disease and tuberous sclerosis complex (TSC)-related epilepsy For More Information Contact:InvestorsSandya von der Weidsvonderweid@lifesciadvisors.com  Mediamedia@cassavasciences.com  This news release contains forward-looking statements that include but are not limited to statements regarding: REFOCUS-ALZ and RETHINK-ALZ the timing for discontinuation of our Alzheimer’s disease development program our plans for the development of investigational treatments for central nervous system disorders our plans to conduct preclinical studies of simufilam relating to seizures in TSC the potential for simufilam as a treatment for TSC-related epilepsy our strategic expense management efforts and the timing of anticipated milestones Share on FacebookShare on X (formerly Twitter)Share on PinterestShare on LinkedInWICHITA (KWCH) - The FBI is seeking information on the whereabouts of two wanted fugitives Arrest warrants were issued for the couple on January 31 in the United States District Court for the District of Kansas They are charged with conspiracy to commit interstate transportation of stolen property Sava and Rostas are accused of targeting various jewelry businesses they allegedly enter the stores in groups of two or more distract or separate the employees to facilitate the theft and ultimately leave the store with jewelry items displayed for sale a method known as “sleight-of-hand distraction” theft The couple is believed to be using multiple aliases and may be living or operating in several states across the U.S. Anyone with information about the whereabouts of Sava and Rostas is encouraged to contact local law enforcement or the FBI via www.tips.fbi.gov or call the National FBI Tip Line at 1-800-CALLFBI 11-25-2024NEWS Shares in the pharmaceutical company fell a staggering 85% on Monday after it reported disappointing Phase 3 results [Photo: Andrew Brookes/Connect Images/Getty Images] BY Grace Snelling In March, pharmaceutical company Cassava Sciences made headlines for a report by the Food and Drug Administration (FDA) that cast doubt on the positive trial results of its novel Alzheimer’s drug Then, in September, the Securities and Exchange Commission (SEC) settled with Cassava over charges that the company had misled investors about the effectiveness of its new drug Cassava announced that its Phase 3 trials of simufilam failed to meet all of its main goals This latest disappointing news came in the form of a company press release which noted that “the topline results from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet each of the pre-specified co-primary secondary and exploratory biomarker endpoints.” The release went on to note that in the wake of these results Cassava decided to discontinue a planned second Phase 3 trial of the drug Cassava Sciences’ stock (NASDAQ: SAVA) plummeted on Monday by a staggering 85% “The results are disappointing for patients and their families who are living with this disease and physicians who have been looking for novel treatment options,” Cassava president and CEO Rick Barry said in a statement “We took careful measures to enroll patients with mild-to-moderate AD the loss of cognition in the placebo group was less pronounced than was previously reported in other placebo-controlled studies in AD We are working to understand this better.” The study’s failure comes after multiple federal agencies called Cassava’s methods into question. Earlier this year, Science reported that an FDA inspection found that City University of New York (CUNY) researcher Hoau-Yan Wang who was involved in Cassava’s clinical tests on simufilam had used questionable data collection practices Then, in June, Wang was indicted by the Department of Justice (DOJ) for allegedly “defrauding the National Institutes of Health (NIH) of approximately $16 million.” The DOJ’s release claimed that Wang had participated in “a scheme to fabricate and falsify scientific data in grant applications made to the NIH on behalf of himself and [Cassava Sciences].” Wang does not appear to have commented on the indictment We reached out to his attorney for comment Cassava said in a statement at the time that “Dr Wang and his former public university medical school have had no involvement in the Company’s Phase 3 clinical trials of simufilam.” Vanderbilt University neuroscientist Matthew Schrag has previously blown the whistle on potentially objectionable data and images from both Wang and Cassava In an interview with Science this September “There is strong evidence of corruption of the basic science and pharmacology data on which the Phase 2 trials were based there is strong evidence of corruption of the Phase 2 trial data on which the Phase 3 trials are based.” The final deadline for Fast Company’s Brands That Matter Awards is Friday, May 30, at 11:59 p.m. PT. Apply today. Fast Company & Inc © 2025 Mansueto Ventures Fastcompany.com adheres to NewsGuard’s nine standards of credibility and transparency. Learn More Cassava Sciences announced that its Phase 3 ReThink-ALZ study of simufilam for mild-to-moderate Alzheimer's disease failed to meet its co-primary The study evaluated changes in cognition and function over 52 weeks using ADAS-COG12 and ADCS-ADL scales the company is discontinuing its second Phase 3 trial Simufilam maintained a favorable safety profile throughout the trial The company reported approximately $149.0 million in cash and cash equivalents as of Q3 2024 Cassava Sciences ha annunciato che il suo studio di Fase 3 ReThink-ALZ su simufilam per il morbo di Alzheimer da lieve a moderato non ha raggiunto i suoi obiettivi co-principali Lo studio ha valutato i cambiamenti nella cognizione e nella funzionalità per 52 settimane utilizzando le scale ADAS-COG12 e ADCS-ADL l'azienda sta interrompendo il suo secondo studio di Fase 3 Simufilam ha mantenuto un profilo di sicurezza favorevole durante tutto il trial L'azienda ha riportato circa 149,0 milioni di dollari in contante e equivalenti di cassa a partire dal terzo trimestre del 2024 Cassava Sciences anunció que su estudio de Fase 3 ReThink-ALZ sobre simufilam para la enfermedad de Alzheimer leve a moderada no logró alcanzar sus objetivos co-principales secundarios y exploratorios de biomarcadores El estudio evaluó los cambios en la cognición y la función durante 52 semanas utilizando las escalas ADAS-COG12 y ADCS-ADL la empresa está discontinuando su segundo ensayo de Fase 3 y el estudio de Extensión de Etiqueta Abierta Simufilam mantuvo un perfil de seguridad favorable durante todo el ensayo La empresa reportó aproximadamente $149.0 millones en efectivo y equivalentes de efectivo hasta el tercer trimestre de 2024 카사바 사이언스는 경증에서 중등도 알츠하이머병을 위한 시무필람의 3상 ReThink-ALZ 연구가 공동 주요 이 연구는 ADAS-COG12 및 ADCS-ADL 척도를 사용하여 52주 동안 인지 및 기능 변화를 평가했습니다 이러한 실망스러운 결과로 인해 회사는 두 번째 3상 시험인 ReFocus-ALZ와 오픈 레이블 확장 연구를 중단하기로 결정했습니다 회사는 2024년 3분기 기준으로 약 1억 4,900만 달러의 현금 및 현금성 자산을 보고했습니다 Cassava Sciences a annoncé que son étude de Phase 3 ReThink-ALZ sur simufilam pour la maladie d'Alzheimer légère à modérée n'a pas réussi à atteindre ses objectifs co-principaux secondaires et d'exploration des biomarqueurs L'étude a évalué les changements de cognition et de fonction sur 52 semaines en utilisant les échelles ADAS-COG12 et ADCS-ADL l'entreprise met fin à son deuxième essai de Phase 3 ainsi qu'à l'étude d'extension en libre-évaluation Simufilam a maintenu un profil de sécurité favorable tout au long de l'essai L'entreprise a rapporté environ 149,0 millions de dollars en espèces et équivalents de liquidités au troisième trimestre 2024 dass die Phase-3-Studie ReThink-ALZ zu simufilam bei leichtem bis mäßigem Alzheimer nicht die co-prime sekundären und explorativen Biomarker-Endpunkte erreichen konnte Die Studie bewertete Veränderungen in Kognition und Funktion über 52 Wochen anhand der ADAS-COG12- und ADCS-ADL-Skalen Aufgrund dieser enttäuschenden Ergebnisse stellt das Unternehmen auch die zweite Phase-3-Studie ReFocus-ALZ und die Open-Label-Erweiterungsstudie ein Simufilam wies während der gesamten Studie ein günstiges Sicherheitsprofil auf Das Unternehmen berichtete über etwa 149,0 Millionen US-Dollar an liquiden Mitteln und Barmitteläquivalenten zum dritten Quartal 2024 The Phase 3 ReThink-ALZ trial results represent a significant setback for Cassava Sciences' Alzheimer's disease program The study failed to meet both co-primary endpoints showing no meaningful difference between simufilam and placebo in cognitive decline (ADAS-COG12) or functional abilities (ADCS-ADL) The unusually low placebo group decline rate raises questions about patient selection and trial design The company's decision to discontinue both the second Phase 3 trial (ReFocus-ALZ) and the Open Label Extension study indicates a complete halt to simufilam's development in Alzheimer's disease but this represents a fundamental challenge to their primary development program This is a devastating outcome for Cassava Sciences effectively invalidating their lead drug candidate and primary business focus combined with the discontinuation of other ongoing trials leaves the company without a clear path forward in the Alzheimer's space While the $149 million cash position provides some runway the company faces significant strategic challenges: Expect significant stock price volatility and potential market cap erosion as investors reassess the company's prospects Simufilam did not show a significant reduction in cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s disease in the ReThink-ALZ Phase 3 study Cassava intends to present the data at an upcoming medical meeting 2024 (GLOBE NEWSWIRE) -- Cassava Sciences investigational treatment for Alzheimer’s disease (AD) dementia today announced that the topline results from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet each of the pre-specified co-primary The co-primary endpoints were the change in cognition and function from baseline to the end of the double-blind treatment period at week 52 The Company will hold a webcast today at 8 AM ET “The results are disappointing for patients and their families who are living with this disease and physicians who have been looking for novel treatment options We took careful measures to enroll patients with mild-to-moderate AD We are working to understand this better,” said Rick Barry “A result like this has implications on our second Phase 3 trial We have made the difficult decision to discontinue ReFocus-ALZ given the nature of today’s reported results The complete 52-week dataset will be available from the study along with a large portion of 76-week data We intend to report detailed analyses of both studies in the future We will also be discontinuing the Open Label Extension study.” “We have a special gratitude for the patients and their families and caregivers who participated in our clinical program for AD We are also immensely grateful to our employees We hope the information we have gathered can ultimately be used to benefit ongoing research in AD.” The table below provides a high-level summary of the co-primary endpoints data Topline analysis of the mild and moderate sub-groups did not demonstrate statistical significance at week 52 100%; border-collapse:collapse ;">Metrics for Simufilam and PlaceboSimufilam 100 mg BIDPlacebo BIDBaseline*Age We plan to share the detailed results at a future medical meeting Chief Financial Officer at Cassava commented Cassava is well-capitalized with approximately $149.0 million in cash and cash equivalents as of the end of the third quarter of 2024.” 100%; border-collapse:collapse ;"> Webcast Info 10%; width:10%; min-width:10%;"> Date: 90%; width:90%; min-width:90%;"> Monday, November 25th Time: 8:00 a.m. Eastern Time Webcast: https://lifescievents.com/event/cassava/    A webcast of the live call will be available in the investor relations section of the Cassava website Access to the webcast replay will be available on the Company’s website approximately two hours after completion of the call for approximately 90 days 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 randomized parallel group study involving over 75 clinical trial sites in the U.S. The trial randomized 804 people with confirmed mild or moderate AD defined by several well validated parameters including a mini-mental state examination (MMSE) of >16 and <27 Subjects were randomized 1:1 to receive simufilam 100 mg (n=403) or a matched placebo (n=401) Secondary endpoints also included several well validated measures of neuropsychiatric symptoms and caregiver burden Safety was evaluated through multiple measures ReThink-ALZ was conducted under a Special Protocol Assessment (SPA) with the U.S Cassava Sciences is a clinical-stage biotechnology company based in Austin Our mission is to detect and treat neurodegenerative diseases small molecule drug candidate that targets the filamin A protein is under evaluation for the potential treatment of Alzheimer's disease worldwide rights to its investigational product candidates and related technologies without royalty obligations to any third party For more information, please visit: https://www.CassavaSciences.com InvestorsSandya von der Weidsvonderweid@lifesciadvisors.com Mediamedia@cassavasciences.com  Cassava Sciences (NASDAQ: SAVA) has announced significant updates following its Phase 3 RETHINK-ALZ study's failure to meet primary endpoints in November 2024 The company is proceeding with the discontinuation of both the Phase 3 REFOCUS-ALZ and Open Label Extension studies with topline results expected in late Q1/early Q2 2025 As part of strategic cost-cutting measures Cassava is implementing a 33% workforce reduction The company is also halting planned biomarker analysis of additional plasma samples from prior Phase 2 studies The workforce reduction will incur approximately $0.4 million in one-time costs The company reports unaudited cash and cash equivalents of $128.6 million as of December 31 Cassava Sciences (NASDAQ: SAVA) ha annunciato importanti aggiornamenti dopo il fallimento del suo studio di Fase 3 RETHINK-ALZ nel raggiungere gli obiettivi primari nel novembre 2024 L'azienda procederà con la sospensione sia dello studio REFOCUS-ALZ di Fase 3 che dell'estensione in open label con i risultati preliminari attesi per la fine del primo o l'inizio del secondo trimestre 2025 Come parte di misure strategiche di riduzione dei costi Cassava sta implementando una riduzione del personale del 33% che influenzerà 10 dipendenti nel primo trimestre del 2025 L'azienda sta anche interrompendo l'analisi pianificata dei biomarcatori di ulteriori campioni di plasma provenienti da studi di Fase 2 precedenti La riduzione del personale comporterà costi una tantum di circa 0,4 milioni di dollari L'azienda riporta liquidità e disponibilità liquide non verificate per un totale di 128,6 milioni di dollari al 31 dicembre 2024 Cassava Sciences (NASDAQ: SAVA) ha anunciado actualizaciones significativas tras el fracaso de su estudio de Fase 3 RETHINK-ALZ en alcanzar los objetivos primarios en noviembre de 2024 La compañía procederá con la discontinuación tanto del estudio REFOCUS-ALZ de Fase 3 como de la Extensión Abierta con resultados preliminares esperados para finales del primer trimestre/principios del segundo trimestre de 2025 Como parte de medidas estratégicas de reducción de costos Cassava está implementando una reducción del 33% en su plantilla afectando a 10 empleados en el primer trimestre de 2025 La compañía también está deteniendo el análisis de biomarcadores de muestras de plasma adicionales de estudios de Fase 2 anteriores La reducción de personal incurrirá en costos únicos de aproximadamente 0,4 millones de dólares La empresa informa de disponibilidades de efectivo y equivalentes de efectivo no auditadas de 128,6 millones de dólares a fecha del 31 de diciembre de 2024 NASDAQ: SAVA)는 2024년 11월에 RETHINK-ALZ 3상 연구가 주요 목표를 달성하지 못한 후 중요한 업데이트를 발표했습니다 이 회사는 3상 REFOCUS-ALZ 연구와 개방형 연장 연구를 중단할 계획이며 전략적 비용 절감 조치의 일환으로 카사바는 33% 인력 감축을 시행하고 있으며 회사는 또한 이전 2상 연구에서 추가 혈장 샘플의 바이오마커 분석을 중단하고 있습니다 회사는 2024년 12월 31일 기준으로 1억 2860만 달러의 감사되지 않은 현금 및 현금성 자산을 보고하고 있습니다 Cassava Sciences (NASDAQ: SAVA) a annoncé d'importantes mises à jour suite à l'échec de son étude de phase 3 RETHINK-ALZ à atteindre les objectifs principaux en novembre 2024 La société s'apprête à arrêter à la fois l'étude REFOCUS-ALZ de phase 3 et celle de l'extension en open label avec des résultats préliminaires attendus à la fin du premier trimestre ou au début du deuxième trimestre 2025 Dans le cadre de mesures stratégiques de réduction des coûts Cassava va mettre en œuvre une réduction de 33% de ses effectifs visant 10 employés au premier trimestre 2025 L'entreprise met également un terme à l'analyse des biomarqueurs prévue pour des échantillons de plasma supplémentaires issus d'études de phase 2 antérieures Cette réduction des effectifs entraînera des coûts uniques d'environ 0,4 million de dollars La société rapporte des liquidités et équivalents de liquidités non audités de 128,6 millions de dollars au 31 décembre 2024 Cassava Sciences (NASDAQ: SAVA) hat nach dem Scheitern der Phase-3-RETHINK-ALZ-Studie im November 2024 bedeutende Aktualisierungen bekannt gegeben Das Unternehmen plant die Einstellung sowohl der Phase-3-REFOCUS-ALZ-Studie als auch der Open-Label-Extension-Studien wobei die Ergebnisschätzungen für Ende Q1/Anfang Q2 2025 erwartet werden Im Rahmen strategischer Kostensenkungsmaßnahmen führt Cassava eine Reduzierung der Belegschaft um 33% durch die 10 Mitarbeiter im ersten Quartal 2025 betrifft Das Unternehmen stoppt auch die geplante Biomarker-Analyse zusätzlicher Plasmaproben aus früheren Phase-2-Studien Die Reduzierung der Belegschaft wird voraussichtlich einmalige Kosten von etwa 0,4 Millionen Dollar verursachen Das Unternehmen berichtet von unauditierten Zahlungsmitteln und Zahlungsmitteläquivalenten in Höhe von 128,6 Millionen Dollar zum 31 The announced workforce reduction of <percent>33%</percent> and cost-cutting measures reflect a significant strategic pivot following the disappointing Phase 3 RETHINK-ALZ trial results With <money>$128.6 million</money> in cash reserves and a <money>$0.4 million</money> one-time restructuring cost the company is prioritizing capital preservation will need careful management as the company evaluates its future direction post-trial failures The market cap of <money>$145.5 million</money> is now trading close to cash value suggesting investors are assigning minimal value to the company's pipeline and intellectual property The upcoming REFOCUS-ALZ results in Q1/Q2 2025 represent a critical inflection point that could determine the company's future trajectory and potential strategic alternatives The discontinuation of both Phase 3 trials and halting of biomarker analysis from Phase 2 studies signals a comprehensive reassessment of simufilam's development program The failure to meet primary endpoints in RETHINK-ALZ raises fundamental questions about the drug's efficacy in treating Alzheimer's disease The decision to analyze the complete 52-week dataset and partial 76-week data from REFOCUS-ALZ suggests a thorough examination to identify any potential subgroups or secondary benefits that might inform future development decisions In simpler terms: The company's main drug didn't work as hoped in treating Alzheimer's They're now stopping all major trials and looking carefully at all the data they've collected to see if there's any silver lining or different way forward 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 investigational treatments for central nervous system diseases including Alzheimer’s disease dementia 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 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 “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 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 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 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.” 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 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 RETHINK-ALZ was conducted under a Special Protocol Assessment (“SPA”) with the U.S REFOCUS-ALZ (NCT05026177) is a Phase 3 trial designed as a multi-center 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. 2024 plans to discontinue the REFOCUS-ALZ study and intends to report topline data from that trial The Company expects to report topline data for this study late first-quarter/early second-quarter 2025 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 76 REFOCUS-ALZ was also conducted under an SPA with the FDA Inc.Cassava Sciences is a clinical-stage biotechnology company focused on developing novel For more information, please visit: https://www.CassavaSciences.com InvestorsSandya von der Weidsvonderweid@lifesciadvisors.com Mediamedia@cassavasciences.com Cassava Sciences is a clinical-stage biopharmaceutical company that focuses on developing novel therapies for neurodegenerative conditions such as Alzheimer’s disease (AD) The company’s tall claims about the potential efficacy of its lead drug candidate in the treatment of AD are at the heart of the current complaint Cassava Sciences and two of its senior officers and/or directors (Individual Defendants) repeatedly made false and misleading public statements throughout the Class Period. Particularly they are accused of omitting truthful information about the potential efficacy of simufilam from SEC filings and related material the defendants consistently reiterated their belief in simufilam and its potential to fight Alzheimer’s disease The company stated favorable top-line results from the Phase II study designed to investigate the safety of simulfilam as a treatment for Alzheimer’s disease dementia the company said that several patients (over 655 patients out of the 735 completed participants) who had completed treatment in the Phase 3 study had opted to enter the open-label extension study Cassava Science’s former science advisor Mr Wang was not involved in Phase 3 clinical trials of simufilam This was followed by the resignation of its then-president and CEO and the appointment of an Executive Chairman and principal executive officer in July 2024 The company was set on a mission to search a new permanent CEO who would help Cassava lead from a clinical-stage company to a commercial stage company subsequent events (discussed below) revealed that Cassava Sciences and the defendants wilfully misled investors about the potential efficiency of simufilam in treating Alzheimer’s disease The plaintiffs maintain that the Defendants deceived investors by lying and withholding critical information about the company’s business and prospects during the Class Period the Defendants are accused of misleading investors about the expected efficacy and commercial benefits of its lead drug candidate The information became clear on November 25 when the company released topline results for the first of its two ongoing Phase 3 studies on simufilam the drug failed to meet the desired pre-specified primary simufilam failed to outperform the placebo during the studies SAVA stock collapsed by 83.8% on November 25 To conclude, the defendants allegedly misled investors about the effectiveness of its simufilam drug in the treatment of Alzheimer’s disease. Owing to these issues, SAVA stock has plunged nearly 91% in the past year causing significant damage to shareholder returns Disclosure Disclaimer & DisclosureReport an Issue To conclude, the defendants allegedly misled investors about the effectiveness of its simufilam drug in the treatment of Alzheimer’s disease. Owing to these issues, SAVA stock has plunged nearly 91% in the past year Disclosure Disclaimer & DisclosureReport an Issue BREAKING: Berkshire Shares Slide On News Of Buffett Exit Cassava Sciences (SAVA) stock plummeted Monday — wiping out more than three-quarters of its value — after the company's Alzheimer's treatment failed in Phase 3 testing in patients with mild-to-moderate Alzheimer's disease patients who received simufilam didn't show a significant reduction in cognitive or functional decline compared to the placebo group "We took careful measures to enroll patients with mild-to-moderate AD," Chief Executive Rick Barry said in a statement We are working to understand this better." That put SAVA stock at its lowest point in four years Cassava examined patients on two scales following 52 weeks of treatment with simufilam while the other focused on patients' abilities to perform activities of daily living But the results didn't meet Cassava's goal The company is now shutting down its second Phase 3 study as well as an ongoing open label extension study patients are all knowingly receiving simufilam The news is a blow to a program that has widely split Wall Street Cassava Sciences stock began to really gain steam in 2021 critics noted the results were from open-label testing where patients know they're receiving the test drug That kicked off a Securities and Exchange Commission investigation He remained with the company for two additional months "in a nonexecutive capacity without duties or responsibilities." Lindsay Burns the company's senior vice president of neuroscience and Barbier's wife SAVA stock tumbled more than 29% on July 17 the day Barbier and Burns left the company That was from a low base under 10 per share Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin AbbVie Jumps 5% On An Upgrade Despite Bristol Myers-Tied Setback RFK Jr. Spooks Weight-Loss Stocks. Should Eli Lilly, Novo Nordisk Be Worried? Looking For The Next Big Stock Market Winners? Start With These 3 Steps Want More IBD Insights? Subscribe To Our Investing Podcast! 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By connecting my portfolio to TipRanks Smart Portfolio I agree to their Terms of Use LONDON, Feb. 25, 2025 /PRNewswire/ -- TERSA, the pioneering health technology company, proudly introduces SAVA Sound Pod to Europe a groundbreaking technology designed to enhance relaxation SAVA will debut in London through an exclusive experience at Four Seasons Hotel London at Tower Bridge from February 20th to 27th The launch will feature an invitation-only pop-up event allowing select guests to experience SAVA's transformative benefits firsthand providing guests with ongoing access to this next-level wellness experience SAVA has garnered significant media attention for its innovative approach to holistic healing leveraging advanced patented sound and sensory technology to aid in stress relief offering guests at Four Seasons Hotel London at Tower Bridge an exclusive opportunity to experience the future of wellness," said Ray Kelly "This collaboration reflects our commitment to providing unparalleled luxury experiences that promote relaxation and well-being." For more information about TERSA, please visit tersa.co or contact: [email protected] To book your SAVA session at Four Seasons Hotel London at Tower Bridge Samantha Jacobson[email protected] 646-272-8432TenXPR.com About SAVASAVA Sound Pod is a state-of-the-art wellness technology designed to enhance relaxation and support holistic healing through sound Created by TERSA's Founder and CEO Ray Kelly—a renowned expert in celebrity pain management and injury rehabilitation for the music industry—SAVA is at the forefront of the latest research in vibroacoustics and biophilic design to create an unparalleled experience that promotes deep rest With SAVA's award-winning Musical Director SAVA combines cutting-edge sound frequencies and vibrations designed to talk directly to the nervous to guide users into a deep state of relaxation About Four Seasons Hotel London at Tower BridgeFour Seasons Hotel London at Tower Bridge offers a unique blend of history and luxury in one of London's most iconic neighborhoods With unparalleled hospitality and a commitment to excellence the hotel caters to both business and leisure travelers alike Featuring three distinguished dining outlets the hotel provides an unforgettable experience in the heart of London for all guests Do not sell or share my personal information: The lead plaintiff deadline is February 10 You can also contact attorney Jonathan Naji, Esq. by calling (484) 270-1453 or by email at info@ktmc.com DEFENDANTS’ ALLEGED MISCONDUCT:The complaint alleges that Defendants made materially false and/or misleading statements as well as failed to disclose material adverse facts about the company’s business Defendants misrepresented and/or failed to disclose that: (1) Cassava’s drug was not capable of abating the progression of Alzheimer’s Disease even in mild to moderate cases; and (2) as a result Defendants’ statements about the company’s business and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times or may choose to do nothing and remain an absent class member A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff Kessler Topaz Meltzer & Check, LLP encourages Cassava investors who have suffered significant losses to contact the firm directly to acquire more information Kessler Topaz Meltzer & Check, LLPJonathan Naji, Esq.(484) 270-1453280 King of Prussia RoadRadnor, PA 19087info@ktmc.com May be considered attorney advertising in certain jurisdictions Past results do not guarantee future outcomes Sava Re will provide up to $10m (€9.25m) in line size for ASR's core classes Africa Specialty Risks (ASR) has entered binding authority agreements with Slovenia-based reinsurance company Sava Re Sava Re will provide up to $10m in line size for ASR’s core classes.  The agreement is said to offer Sava Re enhanced access to risks originating from Africa the Middle East and other developing markets the operating holding company of the Sava Insurance Group services more than 450 partners across more than 100 reinsurance markets globally ASR CEO Mikir Shah said: “Sava Re is one of the strongest reinsurers in CEE [Central and Eastern Europe] with excellent risk and capital management demonstrated by their financial strength ratings Entering into this partnership gives us further access to leading capacity there is a huge demand for specialty insurance solutions and ASR will continue to be at the forefront of meeting this demand.”  Don’t let policy changes catch you off guard Stay proactive with real-time data and expert analysis Sava Re management board chairman Marko Jazbec said: “This agreement with ASR will enable us to increase our footprint in Africa ASR have a strong distribution network across these regions and we can add geographic diversification to our portfolio while knowing that we are partnering with a diligent and leading underwriting-focused firm.”  Earlier this month, ASR received authorisation for ASR North Africa to operate as a Lloyd’s service company.   This authorisation allows the company to underwrite on behalf of Syndicate 2454 providing brokers in Morocco and north-west Africa with direct access to Lloyd’s capacity.  Give your business an edge with our leading industry insights View all newsletters from across the GlobalData Media network Brinks Home a North American home security and alarm monitoring company is pleased to announce the promotion of Sava Tsvetkov to Executive Vice President and Chief Financial Officer (CFO) from Senior Vice President of Finance and Strategy Tsvetkov’s promotion recognizes his exceptional leadership and significant contributions to the company’s growth over the past seven years “Sava has been instrumental in shaping Brinks Home’s financial strategy and his leadership has been integral to our success,” said William Niles and ability to collaborate with senior leadership to develop effective financial strategies have been invaluable to our company I have every confidence that Sava will continue to lead our finance team to new heights and support our efforts to create profitable accounts at scale and serve for life.” Since joining Brinks Home in 2018 as a senior financial analyst Tsvetkov has quickly risen through the ranks serving as Finance Director for the transformation office and as Senior Vice President of Finance and Strategy He has overseen the growth of the company’s Financial Planning and Analysis (FP&A) team and played a crucial role in shaping the company’s pricing and budgeting strategies “I’m honored to take on this new role and excited to continue working alongside our talented finance team and leadership to drive long-term financial success,” said Tsvetkov “The past seven years at Brinks Home have been incredibly rewarding and I look forward to further advancing our financial strategy and supporting the company’s continued growth.” Tsvetkov holds a Master of Science in Finance from the University of Warwick and a Bachelor of Business Administration in Finance from Eastern Michigan University He is also a Chartered Financial Analyst (CFA) Charterholder Tsvetkov spent five years in financial planning and analysis and procurement roles at global manufacturing companies Brinks Home looks forward to Tsvetkov’s continued leadership as it strengthens its financial position and strives to deliver value to its customers and stakeholders (SAVA) has announced the upcoming retirement of its Chief Medical Officer Jack Moore is set to take on the role of Senior Vice President of Clinical Development This transition is part of a broader strategic shift as the company moves to phase out its Alzheimer's program signaling a potential pivot in its business focus The consensus recommendation from two brokerage firms positions Cassava Sciences Inc. (SAVA, Financial) at an average rating of 3.0 which corresponds to a "Hold" status where 1 indicates a Strong Buy and 5 signals a Sell reflects a cautious sentiment towards the stock possibly due to the company's strategic shifts and current market dynamics these insights offer a comprehensive understanding of Cassava Sciences' current standing in the market emphasizing the importance of monitoring strategic changes and market sentiment As the company navigates these transitions staying informed about analyst perspectives and brokerage recommendations will be crucial in making informed investment decisions Cassava Sciences, Inc. (SAVA, Financial) has revealed a leadership transition following the retirement of James Kupiec The company expressed its gratitude for Kupiec's contributions during his tenure Cassava Sciences has appointed Jack Moore to the position of Senior Vice President of Clinical Development Moore will be reporting directly to Rick Barry This appointment is part of the company's strategic efforts to strengthen its clinical development initiatives Based on the consensus recommendation from 2 brokerage firms, Cassava Sciences Inc's (SAVA, Financial) average brokerage recommendation is currently 3.0, indicating "Hold" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell. 20241:49 PM UTCAlgae bloom turns Serbian river greenAerial photos of the River Sava's inlet where water has been covered with algae that thrives in warm and polluted environments [1/13]A drone image shows rowers training in the River Sava's inlet in Belgrade REUTERS/Djordje KojadinovicShare this photo [2/13]A drone image shows a boat cruising in the River Sava's inlet in Belgrade [5/13]A drone image shows a boat cruising in the River Sava's inlet in Belgrade [6/13]A drone image shows a boat cruising in the River Sava's inlet in Belgrade [9/13]A drone image shows boats cruising in the River Sava's inlet in Belgrade [10/13]A drone image shows moored boats in the River Sava's inlet in Belgrade [11/13]A drone image shows a boat cruising in the River Sava's inlet in Belgrade [12/13]A drone image shows boats cruising in the River Sava's inlet in Belgrade [13/13]A drone image shows moored boats in the River Sava's inlet where water has been covered with algae that thrive in warm and polluted environments REUTERS/Djordje KojadinovicShare this photo , opens new tab Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. , opens new tabScreen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. © 2025 Reuters. All rights reserved Cassava released top-line results from the phase III REFOCUS-ALZ study, which evaluated simufilam in patients with mild-to-moderate AD. Treatment with the drug failed to achieve a significant reduction in cognitive and functional decline in AD patients when compared to placebo over 76 weeks, as assessed by the ADAS-COG12 and ADCS-ADL scales. The study also failed to meet any pre-specified secondary and exploratory biomarker endpoints. The REFOCUS-ALZ study had enrolled 1,125 AD patients who were randomized equally to receive either a twice-daily, oral dose of simufilam (50 mg or 100 mg tablets) or placebo for 76 weeks. The candidate, however, demonstrated an acceptable safety profile in the study. Year to date, Cassava shares have plunged 19.5% against the industry’s 0.5% growth. SAVA’s AD Drug Failure in First Late-Stage Study Based on the above study results, SAVA had discontinued the 76-week phase III REFOCUS-ALZ study and the open-label extension study on the drug. Following simufilam’s failure to demonstrate therapeutic benefit in AD patients in two late-stage studies, Cassava expects to phase out the AD program by the end of the second quarter of 2025. Despite the setbacks, SAVA has reportedly initiated preclinical studies to evaluate simufilam’s potential as a treatment for tuberous sclerosis complex-related epilepsy. In early January, Cassava announced plans to reduce its workforce by 33% in first-quarter 2025 as part of ongoing cost management efforts. Additionally, it will discontinue the planned biomarker analysis of plasma samples from past mid-stage studies. The workforce reduction is expected to result in a one-time cost of approximately $0.4 million in first-quarter 2025. Cassava ended the fourth quarter of 2024 with a cash balance of approximately $128.6 million. Cassava Sciences, Inc. Price and Consensus Cassava Sciences, Inc. price-consensus-chart | Cassava Sciences, Inc. Quote Currently, there are two drugs approved by the FDA in the AD space — Leqembi and Kisunla. Both these drugs are approved to treat early symptomatic AD, which includes mild cognitive impairment or dementia stage of the disease. Leqembi, which was approved in 2023, is marketed by Japan-based Eisai in partnership with the Biogen BIIB market. Kisunla was developed by Eli Lilly LLY and received the FDA’s approval in 2024. Eli Lilly and Biogen/Eisai drugs are based on similar mechanisms, reducing the accumulation of amyloid beta (Aβ) plaque in the brain. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with AD. SAVA’s Zacks Rank and Another Stock to Consider Cassava currently carries a Zacks Rank #2 (Buy). Another top-ranked stock from the sector is Gilead Sciences GILD, carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. In the past 30 days, Gilead Sciences’ earnings estimate for 2025 has improved from $7.81 to $7.87 per share. During the same timeframe, the estimate for earnings per share for 2026 has improved from $8.11 to $8.27. Year to date, shares of Gilead Sciences have gained 16.8%. GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%. This article originally published on Zacks Investment Research (zacks.com). Copyright © 2025 FactSet Research Systems Inc.© 2025 TradingView