POINT Biopharma Receives U.S. Nuclear Regulatory Commission Materials License for Indiana Facility
POINT Biopharma announced that the U.S. Nuclear Regulatory Commission has issued a Materials License for its new Indianapolis facility, allowing for the handling of nuclear materials. The 80,000-square-foot manufacturing center aims to be a leading radiopharmaceutical production site. This facility will support the Phase 3 clinical trial for metastatic castration resistant prostate cancer later this year. Additionally, POINT has a merger agreement with Research Alliance Corp. I, with plans to trade under the ticker symbol 'PNT' upon completion.
- NRC Materials License granted, enabling operations with nuclear materials.
- Completion of a state-of-the-art, GMP-compliant manufacturing facility.
- The facility will support a Phase 3 clinical trial for prostate cancer therapy.
- None.
POINT Biopharma Inc. (POINT), a radiopharmaceutical company dedicated to bringing the many benefits of precision radioligand therapy to cancer patients, announced today that the U.S. Nuclear Regulatory Commission (NRC) has issued a Materials License for its new production facility located in Indianapolis, Indiana.
POINT is currently finishing renovations to its 80,000-square-foot radiopharmaceutical manufacturing center which, when complete, will make it one of the largest, state-of-the-art, Good Manufacturing Practices (GMP) radioligand manufacturing facilities in the world. The NRC Materials License authorizes the handling of nuclear material in chemical and/or physical form, enabling POINT to begin work with a wide variety of radioisotopes on-site and complete testing and qualification of its operations.
“The completion of our Indianapolis facility and scope of this Materials License will enable POINT to quickly bring its drug manufacturing operations online,” said Todd Hockemeyer, EVP, US Manufacturing Operations at POINT Biopharma. “Our mission is to make radioligand therapy applicable to more cancers, available to more people, thereby improving the lives of cancer patients and their families everywhere. This Materials License is an important milestone in our journey to deliver on our mission. ”
“I am proud of the many accomplishments Todd and his team in Indiana have achieved,” added Joe McCann, CEO of POINT Biopharma. “Attaining the NRC Materials License means we can get to work using radioisotopes like Lutetium-177 and Actinium-225 at our facility, which is a key milestone in the path to manufacturing our products in Indianapolis.”
POINT expects the Indianapolis facility will begin to provide supply for its Phase 3 clinical trial targeting metastatic castration resistant prostate cancer later this year. More information about POINT’s Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH) is available at https://www.splashtrial.com .
POINT Biopharma has entered into a definitive merger agreement with Research Alliance Corp. I (Nasdaq: RACA). Upon closing, the combined company is expected to be listed on Nasdaq under the ticker symbol “PNT”. A full description of the terms of the business combination can be found in registration statement on Form S-4 filed with the SEC by RACA.
About Therapeutics Acquisition Corp, d/b/a Research Alliance Corp. I
Research Alliance Corp. I is sponsored by RA Capital Management, L.P., and is led by Chairman and CEO Peter Kolchinsky, PhD and CFO Matthew Hammond, PhD. RACA is a blank check company formed for the purpose of effecting a business combination with one or more businesses in the healthcare industry.
About RA Capital Management
RA Capital is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare and life science companies that are developing drugs, medical devices, and diagnostics. The flexibility of its strategy allows RA Capital to provide seed funding to startups and to lead private, IPO, and follow-on financings for its portfolio companies, allowing management teams to drive value creation from inception through commercialization.
About POINT Biopharma
POINT Biopharma is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT is combining a portfolio of best-in-class radiopharmaceutical assets, a seasoned management team, strategic partnerships in radioisotope supply, manufacturing technology and novel direct-to-patient targeting to revolutionize theragnostic drug development and radioligand commercialization. Learn more at https://www.pointbiopharma.com.
Important Information About the Business Combination and Where to Find It
A full description of the terms of the business combination is provided in a registration statement on Form S-4 filed with the SEC by Therapeutics Acquisition Corp. d/b/a/ Research Alliance Corp. I. (“RACA”) which includes a prospectus with respect to the Combined Company’s securities to be issued in connection with the business combination and a proxy statement with respect to the shareholder meeting of RACA to vote on the business combination. RACA urges its investors, shareholders and other interested persons to read the preliminary proxy statement/ prospectus as well as other documents filed with the SEC because these documents will contain important information about RACA, POINT and the business combination. After the registration statement is declared effective, the definitive proxy statement/prospectus to be included in the registration statement will be mailed to shareholders of RACA as of a record date to be established for voting on the proposed business combination. Shareholders will also be able to obtain a copy of the S-4, including the proxy statement/prospectus, and other documents filed with the SEC without charge, by directing a request to: Research Alliance Corp. I, Attn: Secretary, 200 Berkeley St, 18th floor, Boston, MA 02116. The preliminary and definitive proxy statement/prospectus to be included in the registration statement, once available, can also be obtained, without charge, at the SEC’s website (www.sec.gov).
Participants in the Solicitation
RACA and POINT and their respective directors and executive officers may be considered participants in the solicitation of proxies with respect to the proposed business combination described in this press release under the rules of the SEC. Information about the directors and executive officers of RACA is set forth in RACA’s final prospectus for initial public offering filed with the SEC pursuant to Rule 424(b) of the Securities Act of 1933, as amended (the “Securities Act”) on July 9, 2020, and is available free of charge at the SEC’s website at www.sec.gov or by directing a request to: Research Alliance Corp. I, Attn: Secretary, 200 Berkeley St, 18th floor, Boston, MA 02116. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the RACA shareholders in connection with the proposed business combination will be set forth in the registration statement containing the proxy statement/prospectus for the proposed business combination when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated above.
Non-Solicitation
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination and shall not constitute an offer to sell or a solicitation of an offer to buy any securities nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act.
Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of t
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