Cassava Sciences (SAVA) Faces an Indictment and at Least Two Investigations

Cassava Sciences (SAVA) is a Nasdaq issuer that claims to have developed a treatment for Alzheimer’s disease; the product is currently in Phase 3 trials. It’s called Simufilam, and the company says it not only stops the progression of the disease but also reverses its effects. In 2021, its stock spiked and sold off dramatically several times, though its price entered what would become an extended decline in the last months of the year.

In January, it traded for several weeks between $8 and $9 and, by the end of the month, had begun to move into the $20s. On February 4, it briefly climbed over $100. It then pulled back but started another run in late spring. On July 29, it reached a historical intraday high of $146.16 but dropped quickly to close at $103.35. It has not seen those prices since.

All that happened in part because Cassava was treated as a sort of meme stock, though it didn’t have the kind of run enjoyed by GameStop (GME) or AMC Entertainment Holdings (AMC). Still, its fans had an active sub-Reddit, where they proudly called themselves “SAVAges” and dreamt of hitting the jackpot. The board is still alive, though its posters are less enthusiastic as once upon a time.

Worse yet, short sellers had begun to attack the company. It started when the law firm Labaton Sucharow submitted an FDA Citizen Petition on August 23, 2021. The official petitioner was Jordan A. Thomas, an attorney at Labaton. He specializes in helping whistleblowers get their claims heard by the SEC and in seeing to it they’re rewarded for exposing fraud. His clients were not insider whistleblowers. They didn’t work for Cassava. But they were scientists familiar with the kind of work Cassava said it was doing, and for many reasons, they found its published work fishy. They were also (amateur) short sellers. 

The FDA Citizen Petition

The petition was brief but summarized the key points of the real petitioners’ claims:

ACTION REQUESTED

Petitioner is requesting that the FDA halt the current clinical studies of Simufilam (PTI-125) sponsored by Cassava Sciences (NCT04388254 and NCT04994483), pending audits of (1) the publications relied on by Cassava in support of its scientific claims concerning Simufilam; (2) the IND application for Simufilam’s use in Alzheimer’s Disease; and (3) all clinical biomarker studies of Simufilam in Alzheimer’s Disease. Petitioner is further requesting that the FDA oversee third party reanalysis of all clinical biomarker studies of Simufilam in Alzheimer’s disease. The ongoing clinical trials should be paused until the satisfactory completion of these investigations.

STATEMENT OF GROUNDS

 Petitioner has enclosed with this Petition (and incorporates herein) a detailed technical report presenting multiple reasons to question the quality and integrity of the research supporting Cassava’s claims about Simufilam’s use for Alzheimer’s Disease. In sum, that report explains:

(1) All of the foundational science supporting Cassava’s claims about Simufilam’s use for Alzheimer’s Disease comes from a series of papers with two common co-authors (Dr. Hoau-Yan-Wang at City University of New York and Dr. Lindsay Burns of Cassava). The studies of Drs. Wang and Burns were used by Cassava to obtain NIH grants and to open an Investigational New Drug (IND) application to study Simufilam. They form the foundation for the current clinical trials of Simufilam.

(2) No other lab has confirmed Cassava’s research connecting Filamin A to Alzheimer’s Disease, nor has any other lab confirmed that Simufilam binds or modifies Filamin A or has effects in Alzheimer’s Disease models.

(3) Close review of the data and analyses in the foundational research papers and Cassava’s recent publications of clinical trial analyses presents three primary areas of concern:

1. 1. 1. The underlying papers of Drs. Wang and Burns involve extensive use of Western blot analyses to support their claims connecting Simufilam to Alzheimer’s. Detailed analysis of the western blots in the published journal articles shows a series of anomalies that are suggestive of systematic data manipulation and misrepresentation.
      2. Some of the foundational studies published by Drs. Wang and Burns make claims about Simufllam’s effects in experiments conducted on postmortem human brain tissue. The methodology allegedly used in these experiments defies logic, and the data presented again have hallmarks of manipulation.
      3. Cassava’s presentation of clinical biomarker data from the Phase 2b trials raises questions about the validity of the data. The CSF samples in this study were first analyzed by an outside lab, which found that Simufilam was ineffective in improving the primary biomarkers end point and high variability in other biomarkers. But Cassava had these samples analyzed again and this time reported that Simufilam rapidly and robustly improved a wide array of biomarkers. Cassava has not fully published the data from this reanalysis, but a presentation poster that it published on July 26, 2021, which appears to describe aspects of that work, shows signs of data anomalies or manipulation.

(4) Six further aspects of the research by Drs. Wang and Burns are incompatible with scientific norms, and these claims raise further suspicions.

1. 1. 1. Remarkably High Affinity Binding Between PTI-125 and Filamin A.
      2. Remarkably High Affinity Binding Between Naloxone and Filamin A.
      3. Isoelectric Focusing Experiments in Multiple Papers Indicate 100% of Filamin in Altered Conformation in Alzheimer’s Disease and largely Restored to Correct Conformation by PTI-125.
      4. Novel Blood Diagnostic SavaDx Represents Plasma Filamin A Level
      5. PTI-125/Simufilam Improves Memory in a Mouse Model of Alzheimer’s Disease.
      6. PTI-125/Simufilam Blocks the Interaction Between13 amyloid and tx7- Nicotinic Acetylcholine Receptors.

Petitioner submits that the extensive evidence set forth in the enclosed report, which presents grave concerns about the quality and integrity of the scientific data supporting Cassava’s claims for Simufilam’s efficacy, provides compelling grounds for pausing the ongoing clinical trials until the FDA can conduct and complete a rigorous audit of Cassava’s research.

As the baby boom generation has aged in the past 15 years or so, and its members’ lifespans have grown longer, Alzheimer’s has become more prevalent. Nearly seven million Americans are living with the disease. In 2021, it was the fifth-ranked cause of death in people over 65. The hunt for a cure—or at least an effective treatment—is on. There’s no shortage of candidates: as of about a year ago, there were 141 potential treatments undergoing clinical trials. At the beginning of July 2024, the FDA cleared Eli Lilly’s donemab, which will be sold as Kisunla. It’s a monoclonal antibody infusion administered every four weeks. Lilly says it’s been shown to “modestly slow a decline in memory and thinking abilities in people with the disease.” A year ago, the FDA granted full approval to a drug called Lequembi, developed by Japanese pharma Eisai and U.S. pharma Biogen. It’s capable of slowing the progression of the illness by 27 percent over 18 months. Both are extremely expensive. That means Medicare will be placed under greater strain, which will affect everyone over 65. 

If SAVA’s Simufilam is eventually shown to work, it will be an important step forward. Remember: the company claims it not only stops progression but also reverses the disease. Yet the drug has yet to be cleared by the FDA, and the controversy surrounding it has not subsided. 

Attorney Jordan Thomas

Thomas, the lawyer who submitted the petition to the FDA, was not done guiding his clients through the whistleblower process. He submitted evidence to the SEC because it’s the SEC’s Whistleblower program that would, with luck, deliver a payout that he would share in. Another part of his routine as an adviser was to place a story in the Wall Street Journal, where he has connections. For the WSJ to accept a story, however, his clients would have to agree to give up their anonymity. That can be both scary and costly because once identified as Cassava’s attackers, they’d be vulnerable to lawsuits. But they trusted Thomas and emerged from the shadows.

Attorney John Thomas. Source SEC Whistle Blower Advocate website https://secwhistlebloweradvocate.com/our-attorneys/jordan-thomas/

Thomas is a remarkable character. We highly recommend Patrick Rodden Keefe’s fascinating and very long article about him from The New Yorker. Written in January 2022, it’s focused on the Cassava case but ventures into Thomas’s unusual personal history and stories of other whistleblowers he’s worked with. Briefly, he was born in California to a white nun who worked as a schoolteacher and a black man who attended an unaccredited law school and became a judge of sorts. The parents didn’t stay together for long. His mother married another man—a stepfather Thomas didn’t like. For years, he lived with and looked up to his father, but eventually realized he wasn’t honest and, though charismatic, was not a suitable role model. He packed his belongings and moved to Vermont, where he enrolled in Bennington College. It was his intention to become a dancer—Bennington had an excellent program—but in the end, after graduation, he enrolled at Southwestern Law School. While in law school, he worked as a stockbroker. He then joined the Navy and joined the Judge Advocate General’s Corps. Between 1999 and 2003, he worked for the Department of Justice and then moved to the SEC’s Division of Enforcement. While there, he helped create the agency’s Whistleblower program. In 2011, he joined Labaton Sucharow. Finally, in 2022, he formed his own firm called SEC Whistleblower Advocates. 

On Monday, November 15, SAVA filed its quarterly report with the SEC for the period ended September 30, 2021. In the report, it acknowledged that:

Certain government agencies have asked us to provide them with corporate information and documents. We have been cooperating and will continue to cooperate with government authorities. No government agency has informed us that any wrongdoing has occurred by any party. We cannot predict the outcome or impact of any these ongoing matters, including whether a government agency may pursue an enforcement action against us or others.

One of those agencies must have been the FDA. By that time, another Citizen Petition had been received requesting that action be taken against Cassava. That is also reported in the 10-Q. On the 17th, the Wall Street Journal published a story about the company, in which it reported that “[t]he Securities and Exchange Commission is investigating claims that Cassava Sciences Inc., …the sixth-best performing U.S. stock this year, manipulated research results of its experimental Alzheimer’s drug, according to people familiar with the matter.”

Thomas’s clients had agreed to tell their story to the WSJ and allow the newspaper to identify them in its story. They were David Bredt and Geoffrey Pitt, both doctors. Bredt, from San Diego, is a neuroscientist and former researcher at Janssen Pharmaceuticals and Eli Lilly. Geoffrey Pitt, Bredt’s former med school classmate, is a cardiologist who teaches at Weill Cornell Medical College in New York. The two men checked out a presentation Cassava had made at a conference in Denver in July. As they studied the material, they became increasingly outraged by what they saw as a likely scam. Pitt felt the gatekeepers who should have been on guard—the peer reviewers at the journals that published Cassava’s studies; the NIH, which had given the company $20 million in grants; and the FDA, which had let the clinical trials go forward—hadn’t been paying attention. 

And so they contacted Thomas. Both were by then short the stock. Thomas urged them to send their own critical comments, along with examples of Cassava’s research papers, to ten top experts, one of whom was a Nobel Prize winner. All the experts were shocked and disquieted by what they found.

Patrick Radden Keefe, author of the New Yorker article, spoke to several of them. Roger Nicoll of the University of California is an expert on the study of brain slices. He told Keefe that “he was shocked to see Cassava assert that it had tested the effects of its drug on the brains of deceased Alzheimer’s patients which had been frozen and then thawed months, or even years, later. “It’s hard for me to imagine how you could get any life from that tissue… I mean, this is wild. It’s zombie science!”  

In August, Thomas prepared the Citizen Petition and submitted it to the FDA. On the 26th, he issued a press release explaining the submission and the reaction to it. Then in November, the WSJ article in which Bredt and Pitt were identified appeared. 

A few weeks earlier, at the end of October 2021, more critics of Cassava made themselves known, registering their own internet domain and creating a website. Its URL is “cassavafraud.com”, and its internal title is “Cassava Sciences (SAVA): A Shambolic Charade.” Its creators and contributors identify themselves as Enea Milioris, Adrian Heilbut, Jesse Brodkin, and Patrick Markey. Like Bredt and Pitt, they were medical researchers with Ph.D.’s. Less sophisticated and experienced than Bredt and Pitt, they nonetheless felt strongly about what was going on with Cassava. They also created a cloned website called “simuflimflam.com”. 

As if November 2021 weren’t already bad enough for SAVA, hedge fund Quintessential Capital Management LLC (QCM) piled on with its own research report. QCM is run by Gabriel Grego, who describes himself as a value investor and activist short seller. The report on SAVA was called “Cassava Sciences: Game Over!” Unlike the alarmed and outraged scientists who focused on Simufilam and the company’s claims regarding it, Grego took a broader view, giving much of his attention to the issuer’s SEC filings. It makes a valid point about Cassava’s employee benefits program:

Moreover, Cassava’s management has somehow managed to approve what looks to us like an outrageous. compensation system, literally rewarding short-term stock price fluctuations regardless of more traditional metrics as [sic] such as profitability or drug approval milestones.

The plan rewards management if Cassava’s stock reaches certain market capitalization thresholds and holds them for a period of only 20 days. Bonuses range from $10m to $50m per threshold and the thresholds range from $200m to $5bn. Intermediate amounts, unsurprisingly have not been disclosed, but we estimate the total bonus pool to be around $450m. Clearly management would get rich temporarily inflating Cassava’s stock price by creating unlikely expectations for the prospect of its only drug, Simufilam. Should the drug then fail to deliver, and we think it will, shareholders will be wiped out, but management will get to keep their large bonuses.

Grego also discusses at some length a surprising number of employees or individuals associated with Cassava who claim titles they did not earn or use names that may not be theirs, declared bankruptcy and/or engaged in dicey business dealings, or have criminal convictions for fraud or drug charges. One, the principal investigator for the Simufilam trials, had received a serious warning letter from the SEC in 2021. 

That wasn’t all that was wrong with the company’s personnel. Remi Barbier, the founder and CEO, had over 25 years of experience in the biopharmaceutical industry, but not all of them were good ones. What is now Cassava Sciences was once called Pain Therapeutics, Inc.; the name was not changed until 2019. Barbier spent the better part of a decade working on a pain medication called Remoxy. Eventually, a class action was filed, and Barbier was a defendant. What had happened?

Plaintiff alleges Defendants intentionally misled their shareholders regarding the U.S. Food and Drug Administration (FDA) approval process for Remoxy,  PTI’s controlled-release and purportedly abuse-resistant form of the opioid painkiller oxycodone. Specifically, Plaintiff claims after the FDA rejected PTI’s first New Drug Application (NDA) for Remoxy, PTI concealed the nature and extent of the problems with Remoxy from the public, falsely led investors to believe the FDA would approve a resubmitted NDA, and did so while lining its own pockets, rewarding the individual Defendants with unjustifiable compensation packages it asked the shareholders to approve.

That sounds familiar. It was rather like a foreshadowing of what would come a few years later with Simufilam. At issue at that point in the case was a motion to dismiss filed by the defendants. It was denied by the judge.

Barbier’s wife, Lindsay Burns, was a senior vice president of Cassava. She has a Ph.D. in neuroscience and, for what it’s worth, is a rower who won a silver medal at the 1996 Summer Olympics.

We’ve seen that Jordan Thomas, in his Citizen Petition to the FDA based on material furnished by Bredt and Pitt, had emphasized the role played by Dr Hoau-Yan Wang, Ph.D., who was an associated professor at the School of Medicine of the City University of New York (CUNY). Although Cassava was located in Texas, Wang worked as a consultant to the company for years. During that time, many of his research papers were co-authored by Lindsay Burns. He worked on the Simufilam project. Despite his involvement, Wang was not once referenced in SAVA’s 10-K for fiscal year 2022. 

He was not, however, forgotten by those interested in Cassava. His employer, CUNY, conducted a 10-month investigation of his activities. The resulting report, which was substantially finished by late spring 2023, received a few addenda before it became public. (SAVA, enraged, said it must have been “leaked” by short sellers, which didn’t make much sense.) The investigators concluded that:

The committee has found evidence highly suggestive of deliberate scientific misconduct by Dr. Wang for 14 of the 31 allegations. However, we were unable to objectively assess the merit of the allegations due to the failure of Dr. Wang to provide underlying, original data or research records and the low quality of the published images that had to be examined in their place…

Finally, our investigation has revealed long-standing and egregious misconduct in data management and record keeping by Dr. Wang. It appears likely that no primary data and no research notebooks pertaining to the 31 allegations exist… Thus, the integrity of Dr. Wang’s work remains highly questionable.

The report also concludes that Burns bore “primary or partial” responsibility for some of the misconduct, given that she and Wang had published together since the mid-2000s and shared inventor credit on a number of patents related to Simufilam. 

The magazine Science spoke with CUNY biochemist Kevin Gardner, who called the panel’s findings “embarrassing beyond words.”

The Litigation

Cassava was furious from the moment Jordan Thomas filed the Citizen Petition with the FDA. Barbier must have hired lawyers and begun preparations for a lawsuit almost immediately. On November 2, 2022, the company filed against David Bredt, Geoffrey Pitt, Quintessential Capital Management LLC, Adrian Heilbut, Jesse Brodkin, Enea Milioris, and Patrick Markey. The action charged Bredt and Pitt with defamation and conspiracy to defame; Heilbut, Brodkin, Milioris, and Markey (the “Dot.com” Defendants”) with defamation and conspiracy to defame; and QCM with defamation.

That was all. We’d have expected to see a relatively short and simple complaint. One that emphasized what the plaintiff saw as unambiguous, indisputable evidence of the misconduct charged, followed by an explanation of how the defendants’ actions had damaged the company. 

Instead, the complaint was an astonishing 189 pages long, with 106 exhibits. Not long after, the company filed an amended complaint to clear up some jurisdictional issues. Clearly, the intention was to overwhelm the defendants with attorney fees and take up enormous amounts of their time. That would, as defamation suits are often intended to do, encourage the defendants to settle, cough up some money, and keep their mouths shut forever after.

The following day, November 3, Cassava issued a press release about the action, characterizing the defendants as greedy shorts who chose self-enrichment over science. It adds that “[t]he complaint identifies over 1,000 false and defamatory statements made by the Defendants in submissions to the U.S. Food and Drug Administration as well as ‘reports’ and presentations that Defendants published online or on social media…” The defendants would be required to respond to every one of those allegations.

We did not read the entire original complaint or the later amended complaint. Mercifully, the case is over, and since it isn’t precedential, no one needs to bother with it again. 

What happened at the end of what was almost a two-year journey was fascinating, though. In early summer, those years of investigation suddenly began to pay off for company critics, government agencies, the DOJ, and even Alzheimer’s patients who’d been spared the misery of putting their hope in a worthless treatment. On June 28, 2024, Hoau-Yan Wang was indicted by a Maryland grand jury and charged with defrauding the NIH of about $16 million in federal grant funds:

From approximately May 2015 through approximately April 2023, Wang allegedly engaged in a scheme to fabricate and falsify scientific data in grant applications made to the NIH on behalf of himself and the biopharmaceutical company. As alleged, the fraudulent grant applications to the NIH sought funding for scientific research of a potential treatment and diagnostic test for Alzheimer’s disease and resulted in the award of approximately $16 million in grants from approximately 2017 to 2021, part of which funded Wang’s laboratory work and salary. 

Cassava isn’t named, but there’s no doubt it’s the Texas company working on a treatment for Alzheimer’s. Perhaps there will soon be more arrests or civil lawsuits at least. On July 17, Remi Barbier and Lindsey Burns resigned from their positions. Barbier also resigned from the board of directors. But is that just for show? Barbier will stay on till September 13; Burns will provide consulting services for at least one year. If that works out, perhaps she may stay on for another year.

On July 2, however, SAVA disclosed in an 8-K that it had been cooperating with the DOJ and the SEC “in connection with ongoing investigations into the Company and two senior employees of the Company.”

Good thing Cassava’s erstwhile power couple doesn’t have to worry about dealing with that sprawling lawsuit. On March 28, Judge Gregory Woods filed a Memorandum and Order dismissing the suit against all three groups of defendants “[b]ecause the Court finds that the majority of the defendants’ statements were protected under the First Amendment as statements of opinion or scientific debate and that the fraction of statements that were adequately alleged to be defamatory were not published with actual malice, it dismisses Plaintiff’s claims against all of the defendants.”

He granted leave to amend but warned Cassava that any attempt to do so would not be favorably received. Cassava chose not to listen and filed a second amended complaint on April 29. It was 282 pages long, with 192 exhibits attached. It was filed only against Heilbut, Brodkin, Milioris, and Markey. Once again, it was obvious that a frustrated plaintiff was simply seeking some form of revenge. 

As the dog days of summer approached, Cassava had a criminal investigation to deal with. It voluntarily dismissed the case against the remaining defendants on August 2nd. It was finally over. 

The Anti-SLAPP Suit

Or was it? Evidently, Patrick Markey had had enough, but Heilbut, Brodkin, and Milioris had been forced to spend far more money than they could afford on the litigation, and as far as we know, they hadn’t shorted the stock; they’d only tried to alert the scientific community to problems they saw with Simufilam and the studies conducted by Cassava. There was a course of action open to them, and they took it. 

On August 6, they filed suit against Cassava under New York’s anti-SLAPP suit, seeking to recover “their costs and attorney’s fees, compensatory damages, and punitive damages against the company.”

Anti-SLAPP statutes were created to protect our freedom of speech. They provide ordinary citizens with a simple and relatively inexpensive way to fight defamation suits. As we’ve often seen, powerful parties will try to force a settlement and demand silence from defendants who couldn’t afford to defend an action. Usually, the suit brought is a defamation suit. At first, anti-SLAPP actions could only be used against government entities and officials, but courts soon expanded the concept to include corporations and public figures. Anti-SLAPP laws put the burden on the person or entity bringing the suit. He or she must demonstrate that they are likely to win; that is, their claims must be very persuasive. If they aren’t, the case is dismissed. Discovery cannot begin until it’s decided whether the suit qualifies as a SLAPP suit, so it will move along quickly. And finally, court costs and attorney fees will be awarded to the defendant if he or she wins. 

Fortunately for Heilbut, Brodkin, and Milioris, New York, where the original suit against them had been filed, considerably expanded its anti-SLAPP law in late 2020. To qualify as a SLAPP suit, the action must be considered to be in the “public interest.” For New York, that is now seen as “any subject other than a purely private action.” As is the case in most states with anti-SLAPP statutes, motions to dismiss are easier to win, and discovery is delayed. A defendant may receive not only the usual attorneys’ fees and court costs but may also: 

“recover ‘other compensatory damages’ by showing that the plaintiff brought the case to harass, intimidate, punish, or maliciously inhibit free speech, petition, or association rights… A defendant may also recover punitive damages by showing that the plaintiff brought the case “for the sole purpose” of harassing, intimidating, punishing or maliciously inhibiting free speech, petition, or association rights.”

As we shall see, that is exactly what the former “Dot.com Defendants” seek. But they’re plaintiffs now, not defendants, and anti-SLAPP laws are designed to stop the rich and powerful from bringing legal actions to silence opponents. It’s uncertain how that will be addressed. Courts all over the state have ruled that the expanded law applies to cases already pending when the law was changed. But this suit was filed on November 2, 2022, and so would seem not to qualify. 

It is also unclear whether the new law applies in federal court. There is no federal anti-SLAPP statute; some courts accept the New York anti-SLAPP law, or elements of it, and others do not. The Dot.com Defendants’ case is in federal district court, so that could be a problem. 

The complaint is short—only 10 pages—and the arguments are simple. It begins by declaring the plaintiffs’ objective: “Plaintiffs bring this action to recover damages caused by Cassava’s filing and prosecution of a meritless lawsuit against them for the sole purpose of harassing, intimidating, punishing, and maliciously inhibiting public participation in scientific and popular discourse related to Cassava’s experimental Alzheimer’s drug candidate simufilam.”

It’s then pointed out that Cassava’s claims were without basis in fact or law. Naturally, Dr. Hoau-Yan Wang’s indictment is explained, as is the hasty departure of Barbier and Burns, and the reluctance of several scientific journals to publish any criticism of Cassava for fear of retaliation. As well as trying to silence and intimidate Heilbut, Brodkin, and Milioris, a year ago, the company “served improper and overbroad document subpoenas on Plaintiffs, seeking 49 broad categories of documents, ostensibly in connection with a securities class action that Cassava is defending in the Western District of Texas, in a further effort to harass, punish, and intimidate Plaintiffs.”

The plaintiffs then restate their earlier arguments and attach a Prayer for Relief. As we see it, the real question is whether the SDNY will accept at least the elements of the state’s new anti-SLAPP law that Heilbut, Brodkin, and Milioris’s attorneys have seen fit to introduce… It’s a gamble we hope pays off the long-suffering Dot.com Defendants.

Cassava’s story will not end well. Given the leading roles played by Remi Barbier and Lindsay Burns, it’s a bit reminiscent of another biotech disaster, Elizabeth Holmes’s Theranos. Theranos is dead and gone now, and Holmes is in prison, as is her former boyfriend, Sunny Balwani. Both companies seem to have relied on the fake-it-till-you-make-it ethic. It appears that reliance has let them down. 

For further information about this securities law blog, please contact Brenda Hamilton, Securities Attorney, at 200 E. Palmetto Park Rd, Suite 103, Boca Raton, Florida, (561) 416-8956, or by email at [email protected]. This securities law blog post is provided as a general informational service to clients and friends of Hamilton & Associates Law Group and should not be construed as and does not constitute legal advice on any specific matter, nor does this message create an attorney-client relationship. Please note that the prior results discussed herein do not guarantee similar outcomes.

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