POINT Biopharma Reports Third Quarter 2022 Financial Results and Announces Strategic Collaboration and Exclusive License Agreements with Lantheus Holdings

INDIANAPOLIS, Nov. 14, 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 third quarter ended September 30, 2022, and provided an update on business highlights, including the announcement of a strategic collaboration and exclusive license agreements with Lantheus Holdings Inc. (NASDAQ: LNTH) for the commercialization of PNT2002 & PNT2003.

Upon consummation of the agreements, in exchange for the exclusive worldwide rights1, Lantheus will pay a total of $260 million in upfront payments between the two agreements to POINT, with the potential for additional milestone payments of approximately $1.8 billion between the two products based on U.S. Food and Drug Administration (FDA) approval and net sales and commercial milestones. Additionally, Lantheus will pay POINT royalties on net sales, beyond certain financial thresholds and subject to conditions, of 20% for PNT2002 and 15% for PNT2003. Additional terms of the agreements are summarized below and a website with more information about the collaboration is accessible at https://www.strategiccollaboration.net and the Company’s website.

“We are very pleased to have reported the Lantheus strategic collaboration earlier this morning. The terms of the deal affirm for us the value of POINT’s platform and maximizes value for both shareholders and patients,” said Joe McCann, Ph.D., CEO of POINT Biopharma. “We founded POINT to accelerate the discovery, development, and global access to life-changing radiopharmaceuticals, and with this collaboration POINT is now better positioned than ever to execute on our mission. With our financial position further strengthened, we can continue to focus on our core competencies and dedicate resources to our pipeline. Specifically, we believe that PNT2004 is an incredibly exciting, high value opportunity. PNT2004 is our pan-cancer FAP-α program, which is currently in Phase 1. We will also continue to invest in PNT2001, our actinium-225 next-generation PSMA program, which is expected to begin Phase 1 in 2023, and other next-generation radioligand opportunities.”

Recent Developments and Upcoming Milestones

Pipeline Updates

PNT2002: 177Lu-based PSMA targeted radiopharmaceutical

In September 2022, the Company published a poster at ESMO Congress 2022 containing efficacy and safety data from the 27-patient safety and dosimetry lead-in cohort for the Company’s phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The poster was titled “Efficacy and Safety of 177Lu-PNT2002 prostate-specific membrane antigen (PSMA) Therapy in Metastatic Castration Resistant Prostate Cancer (mCRPC): Initial Results from SPLASH” (e-Poster #1400P). Key findings include a median rPFS time of 11.5 months, along with a well-tolerated safety profile with no treatment-related deaths and few treatment-related adverse events of grade 3 or higher.

The SPLASH trial is currently enrolling patients across 55 sites in North America, Europe, and United Kingdom, and recruitment is expected to be completed by the end of the calendar year. The Company continues to expect to report top line data from SPLASH in mid-2023.

PNT2004: fibroblast activation protein-alpha (FAP-alpha) targeted radiopharmaceutical

The phase 1 FRONTIER trial (NCT05432193) for the Company’s pan-cancer fibroblast activation protein-α (FAP-α) targeted program, PNT2004, commenced in July 2022. FRONTIER is evaluating PNT6555 (the lead candidate of PNT2004) in approximately 30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcomas. A gallium-68 (68Ga)-based PNT6555 molecular imaging agent is being used to select patients for the study, those selected then receive a no-carrier-added (n.c.a.) lutetium-177 (177Lu)-based PNT6555 therapeutic agent.

The primary objective of the study is to determine the recommended phase 2 dose (RP2D), as guided by a modified toxicity probability interval-2 design. Phase 1 data from FRONTIER is expected in H1 2024.

PNT2001: 225Ac-labelled next-generation PSMA-targeted radiopharmaceutical

In October 2022, POINT published promising new pre-clinical data from the Company’s next-generation radioligand therapy (RLT) program for prostate cancer, PNT2001. The new PNT2001 data were shared in E-poster #039, “Development and characterization of a next-generation 225Ac-PMSA radioligand,” at the 35th Annual Congress of the European Association of Nuclear Medicine (EANM) in Barcelona, Spain. The Company is targeting an IND/CTA submission for PNT2001 in H1 2023, with the first patient expected for a phase 1 clinical trial by EOY 2023.

Corporate Updates:

In September 2022, the Company closed a previously announced underwritten public offering of 13,900,000 shares of Common Stock at a public offering price of $9.00 per share. Subsequent to closing, the underwriter exercised its option to purchase an additional 1,589,779 shares. The gross proceeds to the Company from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $140 million.

Upcoming Investor Conferences

Management will participate in the following upcoming investor conferences:

Jefferies London Healthcare Conference
Format: Company Presentation (in person) and 1x1 Meetings
Date: Tuesday, November 15, 2022
Time: 5:00pm GMT

Piper Sandler 34th Annual Healthcare Conference
Format: Fireside Chat (in person) and 1x1 Meetings
Date: Tuesday, November 29, 2022
Time: 8:30am EST

5th Annual Evercore ISI HealthCONx Conference
Format: 1x1 Meetings (virtual)
Date: Wednesday, November 30, 2022

Three Months and Nine Months Ended 2022 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2022, POINT had approximately $291.5 million in cash, cash equivalents and investments, which is anticipated to fund operations into the fourth quarter of 2024.

Net Loss: Net loss was $24.0 million, or $0.26 net loss per share, for the three months ended September 30, 2022, as compared to a net loss of $17.1 million, or $0.19 net loss per share, for the same period in 2021. Net loss was $65.0 million, or $0.71 net loss per share, for the nine months ended September 30, 2022, as compared to a net loss of $31.7 million, or $0.46 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 September 30, 2022, as compared to $13.0 million for the same period in 2021. Research and development expenses were $54.1 million for the nine months ended September 30, 2022, as compared to $24.0 million for the same period in 2021.

General and Administrative Expenses: General and administrative expenses were $3.8 million for the three months ended September 30, 2022, as compared to $4.0 million for the same period in 2021. General and administrative expenses were $11.7 million for the nine months ended September 30, 2022, as compared to $7.4 million for the same period in 2021.

1 Excluding the following territories: China (inclusive of Taiwan, Hong Kong and Macau), Japan, South Korea, Indonesia and Singapore, which are retained by POINT.

About the SPLASH Trial

The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 participants across North America, Europe, and the United Kingdom. Participants will be randomized 2:1 with participants in arm A receiving PNT2002 and participants in arm B receiving either abiraterone or enzalutamide. Participants 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 their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics.

About the FRONTIER Trial

The FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability, and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients with Select Solid Tumors (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 68Ga-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) 177Lu-based PNT6555 therapeutic agent. The phase 1 clinical protocol will evaluate PNT6555 in approximately 30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.

About POINT Biopharma Global Inc.

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 aims to transform precision medicine by combining a portfolio of radiopharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like actinium-225 (225Ac) and lutetium-177 (177Lu). POINT’s active clinical trials include FRONTIER, the phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment. More information about the SPLASH trial can be found at https://www.splashtrial.com/. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.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:
Daniel Pearlstein
Associate Director, Corporate Strategy

Unaudited Interim Condensed Consolidated Statements of Operations

(In U.S. dollars)

  For the Three Months Ended
September 30,
 For the Nine Months Ended
September 30,
   2022   2021   2022   2021 
Operating expenses:        
Research and development  20,797,406   13,004,649   54,112,136   23,974,809 
General and administrative  3,839,626   4,026,666   11,727,969   7,440,910 
Total operating expenses  24,637,032   17,031,315   65,840,105   31,415,719 
Loss from operations  (24,637,032)  (17,031,315)  (65,840,105)  (31,415,719)
Other income (expenses):        
Finance income (costs)  1,048,254   (6,178)  1,605,927   (11,840)
Foreign currency (loss) gain  (243,791)  1,905   (287,691)  (32,901)
Total other income (expenses)  804,463   (4,273)  1,318,236   (44,741)
Loss before provision for income taxes  (23,832,569)  (17,035,588)  (64,521,869)  (31,460,460)
Provision for income taxes  (180,500)  (81,044)  (452,021)  (245,251)
Net loss $(24,013,069) $(17,116,632) $(64,973,890) $(31,705,711)
Net loss per basic and diluted common share:

Basic and diluted net loss per common share $(0.26) $(0.19) $(0.71) $(0.46)
Basic and diluted weighted average common shares outstanding  92,401,484   90,121,794   90,891,031   68,317,492 

Interim Condensed Consolidated Balance Sheets

(In U.S. dollars)

 September 30, 2022  
 (Unaudited) December 31, 2021
 $ $
Current assets   
Cash and cash equivalents125,783,126  238,815,991 
Short-term investments165,735,511   
Prepaid expenses and other current assets4,711,979  5,030,565 
Total current assets296,230,616  243,846,556 
Non-current assets   
Property, plant and equipment, net29,457,230  19,412,086 
Total non-current assets29,457,230  19,412,086 
Total assets325,687,846  263,258,642 
Current liabilities   
Accounts payable3,198,646  1,738,470 
Accrued liabilities13,047,645  5,990,516 
Income taxes payable361,723  250,978 
Total current liabilities16,608,014  7,979,964 
Deferred tax liability  65,592 
Total liabilities16,608,014  8,045,556 
Commitments and contingencies   
Stockholders’ equity   
Common Stock, par value $0.0001 per share, 430,000,000 authorized, 104,054,962 and 90,121,794 issued and outstanding as of September 30, 2022 and December 31, 2021, respectively10,405  9,012 
Additional paid-in capital433,936,723  314,488,782 
Accumulated deficit(124,258,598) (59,284,708)
Accumulated other comprehensive loss(608,698)  
Total stockholders’ equity309,079,832  255,213,086 
Total liabilities and stockholders’ equity325,687,846  263,258,642