NEW YORK, June 10, 2020 /PRNewswire/ -- Neurotrope, Inc. (Nasdaq: NTRP) ("Neurotrope" or the "Company") today announced its entry into a strategic agreement with BryoLogyx Inc., www.BryoLogyx.com, for the supply of synthetic, GMP-certified Bryostatin-1, manufactured by Albany Molecular Research, Inc. ("AMRI"), a leading global CDMO provider of advanced drug development and manufacturing solutions. Neurotrope expects to use the synthetic Bryostatin-1 in its clinical development initiatives aimed at advancing its lead product candidate for the treatment of Alzheimer's disease ("AD") and other neurodegenerative diseases and, ultimately, as a source for potential commercial drug supply if regulatory approval is received.
"This strategic partnership with BryoLogyx brings to Neurotrope the first fully synthetic, scalable source of Bryostatin-1, providing a clinical supply for the Company's planned Phase 3 study and a manufacturing alternative that delivers a dramatically superior cost of goods," stated Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope. "Having better ongoing access to Bryostatin-1 drug supply is expected to have a positive impact on our future development efforts and, ultimately, our potential commercialization efforts if regulatory approval is received. Neurotrope has an exclusive license agreement with Stanford University for the use of this synthetic Bryostatin-1 in the treatment of all neurological disorders. In addition, BryoLogyx's innovation-driven work utilizing bryostatins for use in cancer immunotherapy make them an ideal partner to continue advancement of the CD22+ B-cell acute lymphoblastic leukemia ("ALL") development program, where they have the expertise and resources to realize its full potential."
Under the terms of the agreement, BryoLogyx will supply Neurotrope with specified amounts of synthetic, GMP-grade Bryostatin-1., manufactured by AMRI Group. BryoLogyx will pay a fee on gross revenues generated by the commercial sale of Bryostatin-1 product sold by BryoLogyx for the treatment of ALL. In exchange, Neurotrope will transfer to BryoLogyx the program right to develop Bryostatin-1 with CAR-T therapy for the potential treatment of CD22+ B-cell ALL with the National Cancer Institute. Relapsed ALL in CD22 CAR-T treated patients has been associated with reduced CD22 antigen density. Bryostatin-1 has been shown to increase CD22 expression levels, resulting in improved durability of chimeric antigen receptor ("CAR") response. Neurotrope will also transfer to BryoLogyx the Investigational New Drug ("IND") application that is in development, as well as its Cooperative Research and Development Agreement ("CRADA") with the NCI under which Bryostatin-1's ability to modulate CD22 in patients with relapsed/refractory CD22+ disease has been evaluated to date. BryoLogyx will be responsible for the IND and CRADA going forward.
As recently announced, Neurotrope has entered into a definitive merger agreement pursuant to which Metuchen Pharmaceuticals, L.L.C. and Neurotrope have agreed to merge in an all-stock transaction resulting in a newly formed holding company focused on men's health conditions, which will be named Petros Pharmaceuticals, Inc. ("Petros"). Upon closing of the transaction, Bryostatin-1 and substantially all of Neurotrope's existing assets, operations and liabilities, except for cash retained by Petros in accordance with the terms of the merger agreement, will be spun-out into a new, separately traded company which will retain the name Neurotrope Bioscience, Inc. ("NBI").
Dr. Charles S. Ryan, Neurotrope's Chief Executive Officer, added: "As we continue to work toward completing our agreement with Metuchen Pharmaceuticals and offer Neurotrope stakeholders pro-rata ownership in two distinct investment opportunities, we are pleased to have access to synthetic bryostatin. This agreement further underscores the long-term potential of both NBI and Petros as distinct, standalone, publicly-traded companies in two areas of high unmet medical need in the life sciences."
About Neurotrope, Inc.
Neurotrope is a clinical-stage biopharmaceutical company working to develop novel therapies for neurodegenerative diseases. Neurotrope has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease, and preclinical studies for rare diseases and brain injury, including Fragile X syndrome, multiple sclerosis, stroke, Niemann-Pick Type C disease, Rett syndrome, and traumatic brain injury. The FDA has granted Orphan Drug Designation to Neurotrope for Bryostatin-1 as a treatment for Fragile X syndrome. Bryostatin-1 has already undergone testing in more than 1,500 people in cancer studies, thus creating a large safety data base that will further inform clinical trial designs.
Neurotrope has entered into a definitive merger agreement pursuant to which Metuchen Pharmaceuticals, L.L.C. and Neurotrope have agreed to merge in an all-stock transaction resulting in a newly formed holding company focused on men's health conditions, which will be named Petros Pharmaceuticals, Inc. ("Petros"). Upon closing of the transaction, Bryostatin-1 and substantially all of NBI's existing assets, operations and liabilities, except for cash retained by Petros in accordance with the terms of the merger agreement, will be spun-out into a new, separately traded company named Neurotrope Bioscience, Inc.
Additional information about Neurotrope may be found on its website: www.neurotrope.com.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No public offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Important Additional Information Will be Filed with the SEC
In connection with the proposed transaction between Petros, Neurotrope and Metuchen, Petros intends to file relevant materials with the SEC, including a registration statement that will contain a proxy statement and prospectus. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT NEUROTROPE MAY FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS. Stockholders may obtain, free of charge, copies of the definitive proxy statement/prospectus and any other documents filed by Petros with the SEC in connection with the proposed transactions at the SEC's website (www.sec.gov), at Neurotrope's website: www.neurotrope.com, or by directing written request to: Neurotrope, Inc., 1185 Avenue of the Americas, 3rd Floor, New York, New York 10036, Attention: Robert Weinstein.
Participants in the Solicitation
Petros, Neurotrope, Metuchen and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Neurotrope in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger will be included in the proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of Neurotrope is also included in Neurotrope's Definitive Proxy Statement on Schedule 14A relating to the 2019 Annual Meeting of Stockholders, which was filed with the SEC on June 5, 2019. This document is available free of charge at the SEC web site (www.sec.gov), at Neurotrope's website, or by directing a written request to Neurotrope as described above.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. These forward-looking statements include statements regarding Petros, Neurotrope, Metuchen, the combined company, the proposed merger transaction, spin-off and other related matters, the Phase 2 study and further studies, and continued development of use of Bryostatin-1 for AD and other cognitive diseases. Such forward-looking statements are subject to risks and uncertainties and other influences, many of which the Company has no control over. There can be no assurance that the Company will be able to complete the merger transaction with Metuchen or realize the expected benefits from such transaction, the clinical program for Bryostatin-1 will be successful in demonstrating safety and/or efficacy, that we will not encounter problems or delays in clinical development, or that Bryostatin-1 will ever receive regulatory approval or be successfully commercialized. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Additional factors that may influence or cause actual results to differ materially from expected or desired results may include, without limitation, the risk that the conditions to the closing of the proposed transactions are not satisfied, including the failure to obtain stockholder approval for the proposed transactions in a timely manner or at all, uncertainties as to the timing of the consummation of the proposed transactions and the ability of each of Petros, Neurotrope and Metuchen to consummate the proposed transactions, the Company's inability to obtain adequate financing, the significant length of time associated with drug development and related insufficient cash flows and resulting illiquidity, the Company's patent portfolio, the Company's inability to expand its business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, availability of the Company's raw materials, existing or increased competition, stock volatility and illiquidity, and the Company's failure to implement its business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2019 and the Company's Current Report on Form 8-K filed on May 18, 2020. The Company does not undertake to update these forward-looking statements.
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