Oracle Partners, L.P. v. Concentric Analgesics, Inc.

District Court, N.D. California·Decided June 7, 2021·No. 4:20-cv-03775·Unknown

Opinion

ORACLE PARTNERS, L.P., et al., Case No. 20-cv-03775-HSG

Plaintiffs, ORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS’ v. MOTION TO DISMISS

CONCENTRIC ANALGESICS, INC., et al., Re: Dkt. No. 70 Defendants.

Pending before the Court is the motion to dismiss filed by John Donovan, Frank J. Bellizzi, Jr. (collectively, “Individual Defendants”), and Concentric Analgesics, Inc. (“Concentric”). Dkt. Nos. 70 (“Mot.”), 42 (“Opp.”), 51 (“Reply”). For the following reasons, the Court GRANTS IN PART and DENIES IN PART Defendants’ motion to dismiss WITH LEAVE TO AMEND. Concentric is a clinical-stage biopharmaceutical company “developing pain-relieving products, primarily for post-surgical uses, that are injected at the surgical site to provide long- lasting pain relief.” Compl. ¶¶ 19–20. Concentric’s “flagship pain product” is called “CA-008.” Id. at ¶ 21. “Concentric’s management team includes its Founder & President, Dr. John Donovan, and its CEO, Dr. Frank Bellizzi.”1 Id. at ¶ 22. Between 2017 and 2018, Concentric ran clinical trials of CA-008 across three surgical models, including bunionectomies, abdominoplasties, and total knee arthroplasties (“TKA”). Id. at ¶¶ 25–28. Concentric told potential investors that TKA surgeries held the “highest” commercial

1 The complaint details on information and belief that Defendant Donovan “worked for a company that was working on developing a drug similar to CA-008,” and that Defendant Bellizzi “is a dentist by training who was brought in by Dr. Donovan—a friend from college—to help lead potential in terms of profitability. Id. at ¶¶ 27, 44. “CA-008 had shown early promise in bunionectomies, a surgical model with little to no market, yet failed to yield any success in the abdominoplasty surgical trial, which represented a medium sized market for the product.” Id. at ¶ 44. Plaintiffs allege that “present[ing] negative results from the TKA trial” would have made it “extremely difficult for Concentric to raise money from potential investors” and “the market value of Concentric’s shares would have plummeted given CA-008’s greatly reduced prospects for success.” Id. at ¶ 45. Lotus, a clinical research organization hired by Concentric, conducted the TKA trial between November and December 2018 for Cohort 1. Id. at ¶¶ 42, 46–47. On December 22, 2018, Lotus sent a link to “Interim Data” from the TKA Trial “by email to Carole Hodge, Concentric’s Clinical Operations copying Concentric’s President, [Defendant] Donovan, and its Chief Medical Officer (‘CMO’), Dr. Michael Royal.” Id. at ¶ 47. Lotus informed them that it would provide its interim analysis of the data within a week. Id. In the meantime, Dr. Steve Shafer, Concentric’s biostatistician consultant, analyzed the Interim Data, and on December 28, 2018, “he wrote to the Individual Defendants and Royal: ‘Neither the AUC results nor the opioid use results are statistically significant between the groups in the absence of imputation.’ ” Id. at ¶ 48. “Dr. Shafer then wrote that he used two different methods to impute the missing data ‘and the results weren’t pretty.’ ” Id. at ¶ 51. “Dr. Royal, responded to Dr. Shafer that same day: ‘I am not surprised that the key results are not statistically significant; we knew this would happen going in with the small sample size.’ ” Id. at ¶ 52. When Dr. Shafer replied agreeing “completely” with Dr. Royal’s view, he also told them about other methods of presenting the AUC data to investors, but warned that investors may recognize the use of “an unfamiliar statistical test” and that another technique may “scare investors.” Id. at ¶¶ 55–56. Plaintiffs allege that Concentric instead opted to “falsely represent[] . . . that the trial had been successful in meeting its goals by both misrepresenting and obscuring the negative results.” Id. at ¶ 60. On December 31, 2018, Lotus emailed the link for its Interim Analysis to Defendant Donovan, Dr. Royal, and Hodge. Id. at ¶ 61. The Interim Analysis concluded that the TKA value of 0.4871,” which is “nowhere near demonstrating efficacy with statistical significance.”2 Id. at ¶¶ 61–64. On January 2, 2019, Defendant Donovan asked Dr. Royal for assistance “putting [together] a couple of slides . . . to entice” a potential investor, by showing “that the first cohort suggests that we have a shot at succeeding in TKA.” Id. at ¶ 66 (emphasis in original). On January 17, 2019, “Concentric put together a presentation for potential investors, including Plaintiffs, entitled ‘CA-008: TKA SAD Cohort #1; Preliminary Results.’ ” The presentation “represent[ed] that Concentric had achieved both its primary and secondary endpoints . . . at high levels of statistical significance.” Id. at ¶¶ 68–70. On February 15, 2019, “Concentric presented a 107-page ‘Clinical Overview’ to the FDA regarding CA-008” stating that as to Cohort 1 of the TKA trial, “neither” the primary endpoint nor the AUC secondary endpoint was “statistically significant for CA-008 vs. placebo.” Id. at ¶ 72 (emphasis omitted). Between January and May 2019, Defendants “expressly told” Plaintiffs “contrary to the true facts . . . that Cohort 1 of the Phase II TKA Trial had successfully achieved its primary and key secondary efficacy endpoints, and that the trial demonstrated that CA-008 reduced pain and opioid dependency to a statistically significant degree in a surgical model that Concentric represented had the highest commercial value for CA-008.” Id. at ¶ 124. On May 13, 2019, Plaintiffs entered into the Series B Preferred Stock Purchase Agreement (“SPA”) with Concentric and purchased 50.7% of shares issued at a purchase price of $7.6296 per share. Id. at ¶¶ 83–84. Defendants concede that the statements that CA-008 had achieved two of the study’s efficacy endpoints in Cohort 1 with statistical significance were inaccurate. See Mot. at 1. Federal Rule of Civil Procedure 8(a) requires that a complaint contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). A defendant may move to dismiss a complaint for failing to state a claim upon which relief can be granted under Federal Rule of Civil Procedure 12(b)(6). “Dismissal under Rule 12(b)(6) is

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Oracle Partners, L.P. v. Concentric Analgesics, Inc., (N.D. Cal. 2021).

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