Additional data from the lead-in of PNT2002's SPLASH trial on track for fall 2022 release
PNT6555, the lead of the pan-cancer PNT2004 fibroblast activation protein-alpha targeted program, enters Phase 1 clinical trial
INDIANAPOLIS, Aug. 12, 2022 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today announced financial results for the second quarter ended June 30, 2022 and provided an update on business highlights.
“We continue to execute across our pipeline and platform,” said Dr. Joe McCann, CEO of POINT Biopharma. “The Phase 3 SPLASH trial in pre-chemotherapy mCRPC began European randomization in the second quarter, and I look forward to the release of further data from the 27-patient lead-in of the SPLASH trial this fall.”
"One of the achievements from this past quarter I am most proud of is the commencement of the FRONTIER trial - the Phase 1 trial for PNT2004, our pan-cancer fibroblast activation protein targeted program,” Dr. McCann continued. “This program is a true cross-functional collaboration highlighting POINT's strengths in chemistry, radiochemistry, biology, clinical development and regulatory to enable the acceleration of radioligand discovery, progressing from in-license of a non-radiopharmaceutical molecule to a Phase 1 trial for both an imaging agent and a therapeutic agent in just 2 years. 68Ga-PNT6555 and 177Lu-PNT6555, the leads of the PNT2004 program, have now advanced into the clinic, a significant step forward in the development of a pan-cancer theranostic.”
Recent Developments and Upcoming Milestones
PNT2002: 177Lu-based PSMA targeted radiopharmaceutical
In April 2022, the Company dosed its first European Union patient in the SPLASH trial. The SPLASH trial is currently enrolling patients across 53 sites in North America, Europe, and UK, and site activations remain ongoing to expedite accrual. The Company continues to expect to report top line data from SPLASH mid-2023.
PNT2004: fibroblast activation protein-alpha (FAP-alpha) targeted radiopharmaceutical
The Company filed a clinical trial application (CTA) with Health Canada at the end of the first quarter of 2022 for PNT6555, the lead of the pan-cancer PNT2004 fibroblast activation protein-alpha (FAP-alpha) targeted program, and a No Objection Letter was received from Health Canada in May 2022. The first patient was dosed in FRONTIER in July 2022.
The Company also presented posters on PNT6555 at two recent academic conferences including the American Association for Cancer Research (AACR) 2022 Annual Meeting in April 2022, and the Society for Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting in June 2022. Both posters are accessible at https://www.pointbiopharma.com/investors#investor-presentations
In June 2022, the Company appointed Chris Horvath as Executive Vice President, Commercial. Mr. Horvath brings almost twenty years of experience in the pharmaceutical industry, having led or worked on the launch of a number of key oncology products, including Pluvicto (lutetium 177Lu vipivotide tetraxetan), Locametz (gallium 68Ga gozetotide), Nubeqa (darolutamide), and Zytiga (abiraterone acetate). In his new role at POINT, Mr. Horvath will lead the commercial strategy for POINT’s pipeline.
Mr. Horvath began his career as a scientist, working at both DuPont and Novartis Institutes for BioMedical Research. He then transitioned to commercial roles of increasing responsibility at Janssen, Dendreon, Merck, Bayer, and most recently Advanced Accelerator Applications (Novartis). Mr. Horvath holds a BSc in Chemistry & Biology from Wilfrid Laurier University, a MSc in Analytical Science from the University of Guelph, and an MBA from Rutgers Business School.
Three Months and Six Months Ended 2022 Financial Results
Cash, Cash Equivalents and Investments: As of June 30, 2022, POINT had approximately $204.3 million in cash, cash equivalents and investments, which is anticipated to fund operations into the first quarter of 2024.
Net Loss: Net loss was $24.6 million, or $0.27 net loss per share, for the three months ended June 30, 2022, as compared to a net loss of $8.8 million, or $0.15 net loss per share, for the same period in 2021. Net loss was $41.0 million, or $0.45 net loss per share, for the six months ended June 30, 2022, as compared to a net loss of $14.6 million, or $0.26 net loss per share, for the same period in 2021.
Research and Development Expenses: Research and development expenses were $20.8 million for the three months ended June 30, 2022, as compared to $6.7 million for the same period in 2021. Research and development expenses were $33.3 million for the six months ended June 30, 2022, as compared to $11.0 million for the same period in 2021.
General and Administrative Expenses: General and administrative expenses were $4.1 million for the three months ended June 30, 2022, as compared to $1.9 million for the same period in 2021. General and administrative expenses were $7.9 million for the six months ended June 30, 2022, as compared to $3.4 million for the same period in 2021.
About POINT Biopharma
POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT is transforming precision medicine by combining a portfolio of best-in-class radio-pharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like 225Ac and 177Lu. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com/. Information about POINT Biopharma Global Inc.’s Phase 3 SPLASH trial for metastatic castrate resistant prostate cancer (mCRPC) patients can be found at https://www.splashtrial.com/.
About the FRONTIER Trial
The FRONTIER trial is an open-label, Phase 1 trial to evaluate safety, tolerability and dosimetry of 177Lu-PNT6555 and 68Ga-PNT6555, the lead assets of the PNT2004 program. The Phase 1 clinical trial commenced in summer 2022 in Canada and uses a gallium-68 (68Ga)-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) lutetium-177 (177Lu)-based PNT6555 therapeutic agent. The Phase 1 clinical protocol will evaluate PNT6555 in ~30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.
About the SPLASH Trial
The Phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in patients with PSMA-expressing mCRPC who have progressed on Androgen receptor-axis-targeted therapies (ARAT) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 patients across North America, Europe and the United Kingdom. Patients will be randomized 2:1 with patients in arm A receiving PNT2002 and patients in arm B receiving either Abiraterone or Enzalutamide. Patients in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from first PNT2002 dose. 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). POINT anticipates meeting with regulatory agencies in North America, United Kingdom and Europe to gain alignment on requirements for planned submissions after data readout from the SPLASH trial.
Additional information on the Phase 3 SPLASH trial can be found at https://www.splashtrial.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. 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 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, our ability to grow and manage our growth profitably and retain our key employees, the impact of COVID-19 on our business, the success, cost and timing of our product development activities and clinical trials, our ability to obtain and maintain regulatory approval for our product candidates, our ability to obtain funding for our operations, our ability to maintain the listing of our common stock on NASDAQ, changes in applicable laws or regulations, the possibility that POINT may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described in our Annual Report on Form 10-K filed with the SEC on March 25, 2022. Many of these factors are outside of 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.
Investor Relations Contact:
Associate Director, Corporate Strategy
Unaudited Interim Condensed Consolidated Statements of Operations
(In U.S. dollars)
|For the Three Months Ended|
|For the Six Months Ended|
|(In U.S. dollars)||2022||2021||2022||2021|
|Research and development||20,813,882||6,700,862||33,314,730||10,970,160|
|General and administrative||4,080,401||1,949,552||7,888,343||3,414,244|
|Total operating expenses||24,894,283||8,650,414||41,203,073||14,384,404|
|Loss from operations||(24,894,283||)||(8,650,414||)||(41,203,073||)||(14,384,404||)|
|Other income (expenses):|
|Finance income (costs)||509,700||(2,863||)||557,673||(5,662||)|
|Foreign currency loss||(12,259||)||(27,599||)||(43,900||)||(34,806||)|
|Total other income (expenses)||497,441||(30,462||)||513,773||(40,468||)|
|Loss before provision for income taxes||(24,396,842||)||(8,680,876||)||(40,689,300||)||(14,424,872||)|
|Provision for income taxes||(183,405||)||(123,782||)||(271,521||)||(164,207||)|
|Net loss per basic and diluted common share:|
|Basic and diluted net loss per common share||$||(0.27||)||$||(0.15||)||$||(0.45||)||$||(0.26||)|
|Basic and diluted weighted average common shares outstanding||90,124,295||57,582,025||90,123,288||57,116,747|
Interim Condensed Consolidated Balance Sheets
(In U.S. dollars)
|June 30, 2022|
|December 31, 2021|
|Cash and cash equivalents||78,108,242||238,815,991|
|Prepaid expenses and other current assets||5,472,394||5,030,565|
|Total current assets||204,905,051||243,846,556|
|Property, plant and equipment, net||24,441,275||19,412,086|
|Total non-current assets||29,339,571||19,412,086|
|LIABILITIES & STOCKHOLDERS' EQUITY|
|Income taxes payable||509,403||250,978|
|Total current liabilities||18,796,727||7,979,964|
|Deferred tax liability||65,592||65,592|
|Commitments and contingencies|
|Common Stock, par value $0.0001 per share, 430,000,000 authorized, 90,124,962 and 90,121,794 issued and outstanding as of June 30, 2022 and December 31, 2021, respectively||9,012||9,012|
|Additional paid-in capital||315,961,198||314,488,782|
|Accumulated other comprehensive loss||(342,378||)||—|
|Total stockholders’ equity||215,382,303||255,213,086|
|Total liabilities and stockholders’ equity||234,244,622||263,258,642|