POINT Biopharma Inc. (POINT), a global radiopharmaceutical company
dedicated to successfully delivering precision radioligand therapy
to cancer patients, today announced that it has successfully dosed
multiple patients in its Phase 3 SPLASH study evaluating the
efficacy of PNT2002, the Company’s investigational 177Lu-PSMA
targeted radioligand therapy for patients with PSMA expressing
metastatic castration resistant prostate cancer (mCRPC) who are not
eligible for chemotherapy.
The Phase 3 SPLASH study is a multi-center,
randomized, open label assessment of PNT2002 in patients with mCRPC
who have progressed on ARAT therapy and refuse or not eligible for
chemotherapy. The study will commence with a single-arm dosimetry
lead-in and expects to enroll a total of approximately 450 patients
across North America, Europe and the UK. Patients will be
randomized 2:1 with patients in arm A receiving PNT2002 and
patients in arm B receiving either Abiraterone or Enzalutamide. The
primary endpoint of the study is radiographic progression-free
survival (rPFS). Key secondary endpoints include overall response
rate (ORR), overall survival (OS), and pharmacokinetics (PK).
“We are pleased to announce dosing of patients
in our Phase 3 SPLASH study, which represents a significant
milestone for POINT. I am very proud of the work our clinical and
CMC teams have done to bring us to this stage and believe that this
study holds the potential to demonstrate an improvement against the
current standard of care for patients with little to no current
therapeutic options,” said Joe McCann, Chief Executive Officer of
POINT Biopharma. “It is exciting to be working on PSMA targeted
radiopharmaceuticals, a technology which will likely continue to
gain interest as results from studies like the VISION trial are
published. We appreciate the collaboration and engagement from our
trial investigators as well as the guidance from global key opinion
leaders in the field.”
The first patients in the trial were dosed last
month by Dr. Luke Nordquist, Urologic Medical Oncologist, Urology
Cancer Center & GU Research Network, Omaha, Nebraska, and Dr.
Ebrahim Delpassand, Nuclear Medicine Physician, Excel Diagnostics
and Nuclear Oncology Center, Houston, Texas. “There is a
significant unmet need for therapeutic alternatives with a novel
mechanism of action for patients with PSMA expressing mCRPC,
particularly in advance of chemotherapy. The current standard of
care is not sufficient for patients with this aggressive form of
cancer,” said Dr. Nordquist. “As a nuclear medicine physician with
special interest in nuclear Oncology, I have seen an
increasing demand and appreciation for this therapeutic
modality and believe it holds much promise as the future of
precision medicine,” added Dr. Delpassand.
Additional information on the Phase 3 SPLASH
study can be found at
https://www.clinicaltrials.gov/ct2/show/NCT04647526.
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 a registration
statement on Form S-4 filed with the SEC by RACA.
About POINT BiopharmaPOINT
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.
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.
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 these terms
or other comparable terminology, although not all forward-looking
statements contain these words. These statements involve risks,
uncertainties and other factors that may cause actual results,
levels of activity, performance or achievements to be materially
different from the information expressed or implied by these
forward-looking statements. Although we believe that we have a
reasonable basis for each forward-looking statement contained in
this press release, we caution you that these statements are based
on a combination of facts and factors currently known by us and our
projections of the future, about which we cannot be
certain. Forward-looking statements in this press release
include, but are not limited to, statements regarding the proposed
business combination, including the timing and structure of the
business combination, the proceeds from the business combination,
the initial market capitalization of the Combined Company and the
benefits of the business combination, as well as statements about
the potential attributes and benefits of POINT’s product
candidates and the format and timing of POINT’s product
development activities and clinical trials. We cannot assure
you that the forward-looking statements in this press release will
prove to be accurate. These forward-looking statements are
subject to a number of significant risks and uncertainties that
could cause actual results to differ materially from expected
results, including, among others, the ability to complete the
business combination due to the failure to obtain approval from
RACA’s shareholders or satisfy other closing conditions in the
business combination agreement, the occurrence of any event that
could give rise to the termination of the business combination
agreement, the outcome of any legal proceedings that may be
instituted against RACA or POINT following announcement of the
proposed business combination and related transactions, the impact
of COVID-19 on POINT’s business and/or the ability of the
parties to complete the business combination, the ability to obtain
or maintain the listing of RACA’s common stock on Nasdaq following
the proposed business combination, costs related to the proposed
business combination, changes in applicable laws or regulations,
the possibility that RACA or POINT may be adversely affected by
other economic, business, and/or competitive factors, and other
risks and uncertainties, including those to be included under the
header “Risk Factors” in the registration statement on Form S-4 to
be filed by RACA with the SEC and those included under the header
“Risk Factors” in the final prospectus of RACA related to its
initial public offering. Most of these factors are outside of
RACA’s and POINT’s control and are difficult to
predict. Furthermore, if the forward-looking statements prove
to be inaccurate, the inaccuracy may be material. In light of the
significant uncertainties in these forward-looking statements, you
should not regard these statements as a representation or warranty
by us or any other person that we will achieve our objectives and
plans in any specified time frame, or at all. The forward-looking
statements in this press release represent our views as of the date
of this press release. We anticipate that subsequent events and
developments will cause our views to change. However, while we may
elect to update these forward-looking statements at some point in
the future, we have no current intention of doing so except to the
extent required by applicable law. You should, therefore, not rely
on these forward-looking statements as representing our views as of
any date subsequent to the date of this press release.
Company Contact:Ari ShomairVP,
Corporate Affairsmedia@pointbiopharma.com (647) 812-2417
Investor Relations Contact:Alex
LoboStern Investor Relationsinvestors@pointbiopharma.com
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