Freudiger v. Molecular Partners AG

CourtDistrict Court, S.D. New York
DecidedFebruary 5, 2024
Docket1:22-cv-05925
StatusUnknown

This text of Freudiger v. Molecular Partners AG (Freudiger v. Molecular Partners AG) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Freudiger v. Molecular Partners AG, (S.D.N.Y. 2024).

Opinion

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK JAMES MERRITT, individually and on behalf of all others similarly situated, Plaintiffs, 22-cv-5925 (AS)

-against- MEMORANDUM OPINION MOLECULAR PARTNERS AG, et al., AND ORDER Defendants.

ARUN SUBRAMANIAN, United States District Judge: Plaintiff James Merritt alleges that defendant Molecular Partners’ registration statement misled investors by discussing a partnership for the development of a cancer treatment without disclosing that a competitor had a similar treatment that was further along. But Merritt fails to show that the omission of this information rendered existing statements misleading, especially considering the registration statement’s disclosures about “intense” competition in the company’s drug development efforts and “significant competition” in oncology specifically. See Dkt. 23-1 at 8, 166. As such, defendants’ motion to dismiss is GRANTED. BACKGROUND Molecular Partners is a biopharmaceutical company. Am. Compl., Dkt. 18 ¶ 24. In December 2018, it entered into a licensing agreement with Amgen for the clinical development and commercialization of an oncology product, MP0310, for the treatment of fibroblast activation protein (FAP) positive cancers. ¶¶ 27, 29. In 2021, Molecular Partners went public. ¶ 25. At the time, Molecular Partners and Amgen were conducting a Phase 1 clinical trial for MP0310. ¶ 27. The registration statement discussed MP0310, the Amgen licensing agreement, and the trial. Id. On April 26, 2022, Molecular Partners announced that Amgen had terminated the MP0310 licensing agreement. ¶ 45. The next day, the company’s shares fell 37.37%. ¶ 46. Merritt now sues on behalf of a class of shareholders who purchased Molecular Partners shares pursuant or traceable to its registration statement. ¶ 1. He brings claims under §§ 11 and 15 of the Securities Act based on the registration statement’s allegedly misleading statements and omissions. ¶¶ 53–65. The § 11 claim is brought against the company and the officers and directors who signed (or authorized the signing of) the registration statement. The § 15 claim is brought against just the officers and directors. This opinion refers to the defendants collectively as “Molecular Partners.” Merritt identifies six allegedly actionable statements, which can be grouped into three categories: 1. Statements about MP0310 and the Amgen partnership: Statement 1: “We believe our partnership with Amgen allows for a meaningful investigation of combination therapies, given Amgen’s expertise in the field of oncology. ¶ 36 (alterations omitted). Statement 3: “We believe AMG 506 (MP0310) could be particularly relevant as a combination agent with potential combination studies in collaboration with Amgen.” Id. 2. Statements describing the terms of the Amgen agreement: Statement 4: “Under the Amgen Agreement, we and Amgen will jointly evaluate MP0310 / AMG 506 in combination with Amgen’s oncology pipeline products, including its investigational BiTE molecules. In accordance with a mutually agreed development plan, we will conduct the Phase 1a clinical trials and Amgen will be responsible for all subsequent development of MP0310 / AMG 506 after completion of the Phase 1a clinical trials. We and Amgen have established a joint steering committee to oversee the research, information sharing, and potential amendments of the research plan. Each party is responsible for development costs incurred by it until the beginning of Phase 2 clinical trial, after which point the parties will each contribute a fixed percentage of the development costs on the first three indications. Amgen is required to use commercially reasonable efforts to develop MP0310 / AMG 506 in combination with at least one of Amgen’s oncology pipeline products in certain major markets.” ¶ 38. Statement 5: “The Amgen Agreement expires on a country-by-country basis upon the expiration of Amgen’s payment obligations in such country. Amgen may terminate the Amgen Agreement in its entirety for convenience following a certain notice period. Either party may terminate the Amgen Agreement upon an uncured material breach of the agreement or insolvency of the other party following a certain notice period. Following any termination, we have certain rights to receive a license to certain intellectual property generated by Amgen under the Amgen Agreement for purposes of continued development and commercialization of MP0310 / AMG 506.” ¶ 40. 3. Statements describing expectations for MP0310 and the IPO proceeds: Statement 2: “We expect that the ongoing Phase 1 clinical trial of AMG 506 (MP0310), should it demonstrate sustained activity of 4-1BB, will produce data in 2021 to inform potential combination studies which would be conducted by Amgen assets.” ¶ 36 (alternations omitted). Statement 6: “We currently intend to use the net proceeds from this offering, together with our existing cash and cash equivalents, to fund our planned Phase 1 clinical trial of MP0317, to advance the expansion of our research and development activities in our infectious disease program, which is expected to include the selection of an additional product candidate targeting infectious disease and the 2 preclinical research and initiation of IND-enabling studies with respect to this product candidate, to advance our liquid tumor portfolio initially in acute myeloid leukemia through Phase 1 clinical development, and leveraging our CD3 platform to develop additional product candidates thereafter, to advance our platform and other potential product candidates and for working capital and other general corporate purposes. …. We currently expect to use the net proceeds from this offering, together with our existing cash and cash equivalents, as follows: • approximately $25 (CHF 22) million to fund our planned Phase 1 clinical trial for MP0317, the second product candidate in our oncology program, to completion; • approximately $40 (CHF 36) million towards the expansion of our research and development activities in our infectious disease program, which is expected to include the selection of an additional product candidate targeting infectious disease and the preclinical research and initiation of IND-enabling studies with respect to this product candidate; • approximately $43 (CHF 39) million to advance our liquid tumor portfolio initially in acute myeloid leukemia, or AML, through Phase 1 clinical development, and leveraging our CD3 platform to develop additional product candidates thereafter; and • the remainder to fund the advancement of our platform and other potential product candidates, working capital and other general corporate purposes.” ¶ 42. All six statements were misleading, in Merritt’s view, for the same basic reason: they “omitted that the value of the Amgen Agreement to Amgen had changed, materially increasing the likelihood of [Amgen’s] termination of the Amgen Agreement.” ¶ 37. According to Merritt, three of the four patents Molecular Partners had licensed from the University of Zurich were “about to expire.” Id. And Amgen’s competitor, Roche, had begun “enrolling patients in trials for two of its own drug candidates for the treatment of FAP-positive solid tumors, which were each further along and larger than the trial of MP0310.” Id. Roche also had another trial in progress for a third drug candidate. Id. “[T]his increasing competition materially impacted Amgen’s strategy concerning drug candidates for FAP positive tumors, devaluing MP0310 to Amgen and undermining Amgen’s partnership with Molecular Partners.” ¶ 4. “[W]ith the Amgen Agreement in jeopardy,” ¶ 43, it was misleading for Molecular Partners to (1) tout the agreement, (2) describe its potential termination as hypothetical, and (3) discuss using the IPO proceeds for other projects when the agreement’s termination meant those proceeds would have to be used for MP0310 instead, see ¶¶ 37, 41, 43.

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Freudiger v. Molecular Partners AG, Counsel Stack Legal Research, https://law.counselstack.com/opinion/freudiger-v-molecular-partners-ag-nysd-2024.