Initiated randomization phase of Phase 3 SPLASH study of PNT2002 in patients with metastatic castration-resistant prostate cancer (mCRPC)
Expanded FAP alpha inhibitor platform and on track to file an IND/CTA for PNT2004's lead, PNT6555, in the first half of 2022
Completed construction and commissioning of Indianapolis manufacturing facility with first clinical product shipment expected by the end of fiscal 2021
INDIANAPOLIS, Nov. 12, 2021 (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, 2021 and provided a business update.
“In the last quarter, we made significant progress in the development of our next-generation radiopharmaceutical platform,” said Dr. Joe McCann, Chief Executive Officer of POINT. “On the clinical front, our Phase 3 SPLASH study evaluating PNT2002 in mCRPC is now randomizing patients in Canada, with additional sites to open globally in the fourth quarter. In addition, our pan-tumor FAP-alpha targeted program, PNT2004, has demonstrated preclinically that it has the potential to transform precision oncology in patients with rare & refractory solid tumors with limited therapeutic options. Our Indianapolis manufacturing facility is now fully operational, and key radioisotope supply chain pieces are in place, setting us up to be at the forefront of supplying our “just-in-time” radioligand therapies.”
Recent Developments and Upcoming Milestones
Pipeline Updates
PNT2002: Investigational 177Lu-PSMA targeted radioligand therapy
In September 2021, the Company announced that the 25 patient dosimetry and safety run-in for the SPLASH study evaluating PNT2002 for metastatic castrate resistant prostate cancer (mCRPC) met all pre-specified safety and efficacy criteria, allowing the initiation of the randomization phase without changes to study design. Enrollment for this phase of the SPLASH study has commenced in Canada and will continue to expand globally in the fourth quarter of 2021.
PNT2004: Family of FAP-alpha targeted radioligands
In September 2021, the Company reported preclinical data from its fibroblast activation protein-alpha (FAP-alpha) program, PNT2004. In animal models PNT6555, the lead clinical candidate, was able to deliver large doses of radiation to tumors while limiting dose to non-target tissues. PNT6555 also demonstrated a high level of selectivity for FAP, resulting in complete tumor regression and prolonged survival in animal models, including rapid clearance from normal tissues. POINT is progressing through IND enabling studies and clinical development plans with expectations to submit an IND/CTA for PNT2004 in the first half of 2022.
PNT2003: Somatostatin-targeted radioligand therapy
The Company, through its licensing partner CanProbe, is currently evaluating the safety and efficacy of PNT2003 in an open-label, single-arm Phase 3 study in patients with somatostatin receptor-positive neuroendocrine tumors (NETs).
PNT2001: Family of next-generation PSMA radioligands
PNT2001 compounds leverage linker technology that promotes increased tumor accumulation, potentially enabling lower doses of radioisotope, which may induce a similar level of tumor killing while reducing the risk of off target toxicity. The Company plans to advance a single compound from the family for the treatment of prostate cancer and expects to initiate IND-enabling studies for the program in 2022.
CanSEEK™ Tumor Microenvironment (TME) Targeting Technology
POINT’s FAP-alpha activated prodrug technology is being developed to limit a ligand’s ability to bind with receptors on healthy cells, with the goal of preventing off-target delivery and improving therapeutic index. This program is currently in preclinical development.
Corporate Updates:
Manufacturing:
POINT Biopharma’s Indianapolis manufacturing facility opened on October 14, 2021. The 80,000 square foot, state-of-the-art production facility is fully operational and expected to ship its first dose by the end of fiscal 2021.
Partnerships:
In September 2021, The Company exercised its option on the PNT2004 technology and amended the exclusive global licensing agreement with Bach Biosciences providing the Company with the opportunity to further expand uses with the highly FAP specific D-Ala-boroPro inhibitor as a targeting warhead.
Upcoming Events:
The Company’s Chief Executive Officer, Dr. Joe McCann will participate in the following upcoming investor conferences.
Jefferies London Healthcare Conference
Date: November 16-19, 2021
Fireside Chat: A pre-recorded presentation will be made available on November 18, 2021.
Piper Sandler 33rd Annual Healthcare Conference
Date: November 29 - December 2, 2021
Fireside Chat: A pre-recorded presentation will be made available on November 22, 2021.
The First Principles of Radiopharmaceuticals Webinar
Date: December 6, 2021
Registration Link: https://hub.pointbiopharma.com/dec2021
Webinar: The company is hosting an educational event highlighting radiopharmaceuticals, their therapeutic benefit, and commercial considerations.
To access the webcasts and subsequent archived recordings of each presentation, please visit the Company’s website, www.pointbiopharma.com, under "Events" in the investors section. An archived replay of the webcast will be available for approximately 30 days.
Third Quarter 2021 Financial Results
Net Loss: Net loss was $17.1 million, or $0.19 net loss per share, for the quarter ended September 30, 2021, as compared to a net loss of $3.0 million, or $0.06 net loss per share, for the same period in 2020.
Research and Development Expenses: Research and development expenses were $13.0 million for the quarter ended September 30, 2021, as compared to $2.5 million for the same period in 2020.
General and Administrative Expenses: General and administrative expenses were $4.0 million for the quarter ended September 30, 2021, as compared to $596.2 thousand for the same period in 2020.
Cash and Cash Equivalents: As of September 30, 2021, POINT had approximately $252.8 million in cash and cash equivalents, which is anticipated to fund operations into the first quarter of 2024.
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 radiopharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like Actinium-225 and Lutetium-177.
About the SPLASH Study
The Phase 3 SPLASH study (NCT04647526) 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 UK. 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 study 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 regarding the benefits of the recently completed 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 outcome of any legal proceedings that may be instituted against POINT following the closing of the business combination, the risk that the business combination disrupts current plans and operations, the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of POINT to grow and manage growth profitably and retain its key employees, the impact of COVID-19 on POINT’s business, the ability to maintain the listing of POINT’s common stock on the 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 POINT's S-1 registration statement filed with the SEC on July 30, 2021. Most 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.
Contact:
Ari Shomair
media@pointbiopharma.com
(647) 812-2417
Investor Relations Contact:
Alex Lobo
Stern Investor Relations
investors@pointbiopharma.com
Unaudited Interim Condensed Consolidated Statements of Operations
(In U.S. dollars)
| For the three months ended | For the nine months ended | |||||||||||||||||||
| September 30, 2021 | September 30, 2020 | September 30, 2021 | September 30, 2020 | |||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||
| Operating expenses | ||||||||||||||||||||
| Research and development | 13,004,649 | 2,480,064 | 23,974,809 | 5,024,980 | ||||||||||||||||
| General and administrative | 4,026,666 | 596,164 | 7,440,910 | 2,687,161 | ||||||||||||||||
| Total operating expenses | 17,031,315 | 3,076,228 | 31,415,719 | 7,712,141 | ||||||||||||||||
| Loss from operations | (17,031,315 | ) | (3,076,228 | ) | (31,415,719 | ) | (7,712,141 | ) | ||||||||||||
| Other (expenses) income | ||||||||||||||||||||
| Finance costs | (6,178 | ) | (2,507 | ) | (11,840 | ) | (2,507 | ) | ||||||||||||
| Foreign currency gain (loss) | 1,905 | 31,485 | (32,901 | ) | (33,928 | ) | ||||||||||||||
| Total other expenses (income) | (4,273 | ) | 28,978 | (44,741 | ) | (36,435 | ) | |||||||||||||
| Loss before provision for income taxes | (17,035,588 | ) | (3,047,250 | ) | (31,460,460 | ) | (7,748,576 | ) | ||||||||||||
| Provision for income taxes | (81,044 | ) | — | (245,251 | ) | (73,505 | ) | |||||||||||||
| Net loss | (17,116,632 | ) | (3,047,250 | ) | (31,705,711 | ) | (7,822,081 | ) | ||||||||||||
| Net loss per basic and diluted common share: | ||||||||||||||||||||
| Basic and diluted net loss per common share | $ | (0.19 | ) | $ | (0.06 | ) | $ | (0.46 | ) | $ | (0.23 | ) | ||||||||
| Basic and diluted weighted average common shares outstanding | 90,121,794 | 54,181,325 | 68,317,492 | 33,579,905 | ||||||||||||||||
Interim Condensed Consolidated Balance Sheets
(In U.S. dollars)
| September 30, 2021 (Unaudited) | December 31, 2020 | |||||||
| $ | $ | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | 252,825,718 | 10,546,749 | ||||||
| Prepaid expenses and other current assets | 6,468,219 | 1,850,346 | ||||||
| Total current assets | 259,293,937 | 12,397,095 | ||||||
| Property, plant and equipment | 17,901,979 | 9,797,400 | ||||||
| Total assets | 277,195,916 | 22,194,495 | ||||||
| LIABILITIES & STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | 3,218,234 | 3,596,634 | ||||||
| Accrued liabilities | 4,674,266 | 1,479,041 | ||||||
| Income taxes payable | 201,629 | 87,882 | ||||||
| Total current liabilities | 8,094,129 | 5,163,557 | ||||||
| Deferred tax liability | 62,719 | — | ||||||
| Mortgage payable, net of debt discount | — | 3,550,660 | ||||||
| Total liabilities | 8,156,848 | 8,714,217 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Common stock, par value $0.0001 per share, 430,000,000 authorized, 90,121,794 and 54,647,656 issued and outstanding as of September 30, 2021 and December 31, 2020, respectively ("Common Stock") | 9,012 | 5,465 | ||||||
| Additional paid-in capital | 314,117,994 | 26,857,040 | ||||||
| Accumulated deficit | (45,087,938 | ) | (13,382,227 | ) | ||||
| Total stockholders' equity | 269,039,068 | 13,480,278 | ||||||
| Total liabilities and stockholders' equity | 277,195,916 | 22,194,495 | ||||||
Unaudited Interim Condensed Consolidated Statements of Cash Flows
(In U.S. dollars)
| For the nine months ended | |||||||
| September 30, 2021 | September 30, 2020 | ||||||
| $ | $ | ||||||
| Cash flows from operating activities | |||||||
| Net loss: | (31,705,711 | ) | (7,822,081 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Deferred income taxes | 62,719 | — | |||||
| Stock-based compensation expense | 1,931,819 | 1,619,048 | |||||
| Amortization of debt issuance costs | 11,840 | 2,507 | |||||
| Changes in operating assets and liabilities | |||||||
| Prepaid expenses and other current assets | (4,617,873 | ) | (82,611 | ) | |||
| Accounts payable | (378,400 | ) | 1,957,578 | ||||
| Accrued liabilities | 3,077,699 | 458,988 | |||||
| Income taxes payable | 113,747 | 73,505 | |||||
| Amount due to related party within accrued liabilities | 117,526 | 7,233 | |||||
| Net cash used in operating activities | (31,386,634 | ) | (3,785,833 | ) | |||
| Cash flows from investing activities | |||||||
| Purchase of property, plant and equipment | (8,104,579 | ) | (6,090,918 | ) | |||
| Net cash used in investing activities | (8,104,579 | ) | (6,090,918 | ) | |||
| Cash flows from financing activities | |||||||
| Issuance of common stock and warrants to purchase common stock of POINT Biopharma Inc. | — | 25,426,254 | |||||
| Costs and fees on issuance of Common Stock | — | (324,555 | ) | ||||
| Borrowings on mortgage payable, net of debt discount | — | 3,545,306 | |||||
| Repayment of mortgage payable | (3,562,500 | ) | — | ||||
| Issuance of shares of Common Stock in connection with exercise of warrants | 20,000,000 | — | |||||
| Issuance of shares of Common Stock in connection with stock option exercises | 450,000 | — | |||||
| Issuance of shares of Common Stock in connection with the business combination, net of costs incurred by RACA and direct and incremental costs paid | 264,882,682 | — | |||||
| Net cash provided by financing activities | 281,770,182 | 28,647,005 | |||||
| Net increase in cash and cash equivalents | 242,278,969 | 18,770,254 | |||||
| Cash and cash equivalents, beginning of period | 10,546,749 | — | |||||
| Cash and cash equivalents, end of period | 252,825,718 | 18,770,254 | |||||
| Supplemental disclosures of cash flow information | |||||||
| Cash paid for income taxes | (68,785 | ) | — | ||||
| Cash paid for interest on mortgage payable | (92,338 | ) | — | ||||
