Cassava Sciences Resolves SEC Investigation
Cassava Sciences, Inc. (Nasdaq: SAVA) has reached a settlement with the SEC to resolve a previously-disclosed investigation. The company agreed to pay a $40 million penalty for negligence-based disclosure charges related to its 2020 Phase 2b clinical trial of simufilam. Two former senior employees also settled charges. Cassava cooperated with the investigation and implemented remedial measures.
The company does not anticipate charges from the DOJ's Criminal Division. On July 17, 2024, Cassava appointed Richard Barry as Executive Chairman, who became CEO on September 6, 2024. The company remains focused on completing ongoing Phase 3 trials of simufilam for Alzheimer's disease.
Cassava's expected net cash use in operations for the second half of 2024 is $80 to $90 million, including the penalty. The company maintains its estimate of $117 to $127 million cash at year-end 2024.
Cassava Sciences, Inc. (Nasdaq: SAVA) ha raggiunto un accordo con la SEC per risolvere un'indagine precedentemente divulgata. L'azienda ha accettato di pagare una sanzione di 40 milioni di dollari per accuse di divulgazione negligente relative al suo studio clinico di Fase 2b sul simufilam del 2020. Anche due ex dipendenti senior hanno concordato un accordo riguardo alle accuse. Cassava ha collaborato con l'indagine e ha implementato misure correttive.
L'azienda non prevede accuse da parte della Divisione Criminale del DOJ. Il 17 luglio 2024, Cassava ha nominato Richard Barry come Presidente Esecutivo, che è diventato CEO il 6 settembre 2024. L'azienda rimane concentrata sul completamento dei trial di Fase 3 del simufilam per la malattia di Alzheimer.
Il previsto utilizzo netto di cassa da parte di Cassava per le operazioni nella seconda metà del 2024 è di 80-90 milioni di dollari, inclusa la sanzione. L'azienda mantiene la sua stima di 117-127 milioni di dollari di cassa a fine anno 2024.
Cassava Sciences, Inc. (Nasdaq: SAVA) ha llegado a un acuerdo con la SEC para resolver una investigación previamente divulgada. La empresa acordó pagar una por cargos de divulgación negligente relacionados con su ensayo clínico de Fase 2b de simufilam en 2020. Dos ex-empleados senior también llegaron a un acuerdo respecto a los cargos. Cassava cooperó con la investigación e implementó medidas correctivas.
La empresa no anticipa cargos por parte de la División Criminal del DOJ. El 17 de julio de 2024, Cassava nombró a Richard Barry como Presidente Ejecutivo, quien se convirtió en CEO el 6 de septiembre de 2024. La empresa se mantiene enfocada en completar los ensayos de Fase 3 de simufilam para la enfermedad de Alzheimer.
Se espera que el uso neto de efectivo en operaciones de Cassava para la segunda mitad de 2024 sea de entre 80 y 90 millones de dólares, incluyendo la multa. La empresa mantiene su estimación de 117 a 127 millones de dólares en efectivo a finales de 2024.
카사바 사이언스(Cassava Sciences, Inc.) (Nasdaq: SAVA)는 SEC와 합의를 도출하여 이전에 공개된 조사를 해결했습니다. 회사는 2020년 시무필람(simufilam) 임상 시험 2b 단계와 관련된 과실 기반 정보 공개 혐의로 4천만 달러의 벌금을 지불하기로 합의했습니다. 두 명의 전 고위 임원도 혐의를 해결했습니다. 카사바는 조사에 협력하고 개선 조치를 시행했습니다.
회사는 DOJ의 형사 부서로부터 기소를 예상하지 않습니다. 2024년 7월 17일 카사바는 리차드 배리(Richard Barry)를 집행 의장으로 임명했으며, 그는 2024년 9월 6일 CEO가 되었습니다. 회사는 알츠하이머 병에 대한 시무필람의 3상 시험을 완료하는 데 집중하고 있습니다.
2024년 하반기 카사바의 운영을 위한 예상 순 현금 사용액은 벌금을 포함하여 8천만 달러에서 9천만 달러 사이입니다. 회사는 2024년 연말까지 1억 1천7백만에서 1억 2천7백만 달러의 현금 추정을 유지하고 있습니다.
Cassava Sciences, Inc. (Nasdaq: SAVA) a conclu un accord avec la SEC pour résoudre une enquête précédemment divulguée. L'entreprise a accepté de payer une amende de 40 millions de dollars pour des accusations liées à des divulgations négligentes en rapport avec son essai clinique de Phase 2b sur le simufilam en 2020. Deux anciens employés de haut niveau ont également réglé des accusations. Cassava a coopéré avec l'enquête et a mis en œuvre des mesures correctives.
L'entreprise ne prévoit pas de charges de la part de la Division Criminelle du DOJ. Le 17 juillet 2024, Cassava a nommé Richard Barry en tant que Président Exécutif, qui est devenu CEO le 6 septembre 2024. L'entreprise reste concentrée sur l'achèvement des essais de Phase 3 du simufilam pour la maladie d'Alzheimer.
La société prévoit d'utiliser entre 80 et 90 millions de dollars de liquidités pour ses opérations au second semestre 2024, y compris l'amende. L'entreprise maintient son estimation de 117 à 127 millions de dollars de liquidités à la fin de l'année 2024.
Cassava Sciences, Inc. (Nasdaq: SAVA) hat eine Einigung mit der SEC erzielt, um eine zuvor bekannt gegebene Untersuchung zu klären. Das Unternehmen hat zugestimmt, eine Strafe von 40 Millionen Dollar wegen nachlässiger Offenlegungsanklagen im Zusammenhang mit seiner klinischen Studie der Phase 2b zu simufilam aus dem Jahr 2020 zu zahlen. Zwei ehemalige Führungskräfte haben ebenfalls einen Vergleich geschlossen. Cassava kooperierte mit der Untersuchung und implementierte Abhilfemaßnahmen.
Das Unternehmen erwartet keine Anklagen von der Strafrechtsabteilung des DOJ. Am 17. Juli 2024 ernannte Cassava Richard Barry zum Executive Chairman, der am 6. September 2024 CEO wurde. Das Unternehmen konzentriert sich weiterhin auf den Abschluss der Phase-3-Studien zu simufilam für die Alzheimer-Krankheit.
Die erwartete Nettokassenverwendung von Cassava für die Betriebe in der zweiten Hälfte des Jahres 2024 liegt bei 80 bis 90 Millionen Dollar, einschließlich der Strafe. Das Unternehmen hält an seiner Schätzung von 117 bis 127 Millionen Dollar Bargeld zum Jahresende 2024 fest.
- Resolution of SEC investigation allows company to focus on Phase 3 trials
- No anticipated charges from DOJ's Criminal Division
- Appointment of new Executive Chairman and CEO to enhance corporate governance
- Maintained cash estimate of $117 to $127 million at year-end 2024 despite penalty
- $40 million monetary penalty paid to SEC
- Negligence-based disclosure charges related to 2020 Phase 2b clinical trial results
- Settlement involving two former senior employees
- Increased cash use in operations due to penalty payment
Insights
The SEC settlement marks a significant development for Cassava Sciences, resolving a major regulatory issue. The
- The settlement addresses negligence-based disclosure charges without admission of guilt.
- The DOJ's Criminal Division is not expected to bring charges, reducing legal risk.
- New leadership and governance changes signal a commitment to transparency and ethical practices.
This resolution allows Cassava to refocus on its core business - developing simufilam for Alzheimer's disease. The company's ability to maintain its cash projection despite the penalty suggests financial stability. However, investors should monitor how this settlement affects Cassava's reputation and future disclosures. The ongoing Phase 3 trials now become the critical focus for the company's future prospects.
The settlement's financial implications are significant but manageable for Cassava Sciences. Key financial aspects:
- The
$40 million penalty is incorporated into the company's projected cash use of$80-90 million for H2 2024. - Year-end 2024 cash estimates remain unchanged at
$117-127 million , indicating strong cash management. - No additional equity raise appears necessary to cover the penalty.
While the penalty impacts short-term financials, Cassava's ability to absorb it without altering year-end projections is positive. Investors should focus on the company's burn rate and the potential market for simufilam if Phase 3 trials succeed. The resolution of regulatory issues may improve Cassava's standing with institutional investors, potentially supporting the stock price. However, the company's future hinges on clinical trial outcomes and FDA approval.
AUSTIN, Texas, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (“Cassava” or the “Company”) (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced that it has reached a settlement with the U.S. Securities and Exchange Commission (“SEC”) of negligence-based disclosure charges that resolve a previously-disclosed SEC investigation into statements made by the Company pertaining to the results of its 2020 Phase 2b clinical trial of simufilam and related matters. Two former senior employees of the Company also settled negligence-based disclosure charges brought by the SEC.
Cassava, without admitting or denying the SEC’s allegations, agreed to pay a monetary penalty of
In connection with the previously-disclosed investigation by the Department of Justice (“DOJ”), the Company does not currently anticipate that DOJ’s Criminal Division will bring charges against or seek a resolution with the Company.
On July 17, 2024, Cassava announced the appointment of Richard (Rick) Barry as Executive Chairman of the Board as well as a series of actions designed to enhance corporate governance, transparency, and accountability, consistent with the Company’s commitment to the highest ethical business practices. Mr. Barry became Chief Executive Officer of Cassava on September 6, 2024.
“We would like to thank the staff of the Division of Enforcement for its professionalism and its engagement with the Company, which enabled the Board to conduct its own internal investigation and to take decisive action,” said Mr. Barry.
“Cassava is pleased to put this matter behind us,” Mr. Barry said. “We can now focus all of our attention on completion of the ongoing Phase 3 trials of simufilam. While no one can accurately predict the future, we remain hopeful that the trials will be successful and that, after a rigorous FDA review, simufilam could become available to help those suffering from Alzheimer’s disease.”
As previously announced, Cassava’s net cash use in operations for the second half of 2024 is expected to be
Cautionary Note Regarding Forward-Looking Statements
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that may include but are not limited to statements regarding: the impact on the Company of its settlement with the SEC; the status of, and developments related to, DOJ inquiries and investigations; the implementation of remedial measures and actions to enhance governance, transparency and accountability; the advancement and outcome of our on-going Phase 3 clinical trials of simufilam in patients with Alzheimer's disease; the safety or efficacy of simufilam in people with Alzheimer’s disease dementia; potential benefits, if any, of our product candidates; and expected cash balances and cash use in future periods. These statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” and other words and terms of similar meaning.
Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, risks relating to: any continuing investigation by DOJ, including investigation of the conduct alleged in the indictment of Dr. Hoau-Yan Wang announced by DOJ on June 28, 2024; approval by the U.S. District Court of the settlement with the SEC; the ability to conduct or complete clinical studies on expected timelines and within expected budgets; the ability to demonstrate the specificity, safety, efficacy, or potential health benefits of our product candidates; our current expectations regarding timing of clinical data for our Phase 3 clinical trials; any expected clinical results of Phase 3 clinical trials; potential benefits, if any, of our product candidates; and those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, in our Quarterly Report on Form 10-Q for the period ended June 30, 2024, and in subsequent reports filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release.
All our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates are approved or available for sale anywhere in the world.
For more information:
Sitrick And Company
Mike Sitrick: Mike_Sitrick@Sitrick.com
Seth Lubove: slubove@sitrick.com
1-800-550-7521
NY:
Rich Wilner: rwilner@sitrick.com
1-800-699-1481
FAQ
What was the outcome of the SEC investigation into Cassava Sciences (SAVA)?
How much is Cassava Sciences (SAVA) expected to spend in the second half of 2024?
What is the current status of Cassava Sciences' (SAVA) simufilam trials for Alzheimer's disease?
Who is the new CEO of Cassava Sciences (SAVA) as of September 2024?
