UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported): August 13, 2021

 

 

 

POINT BIOPHARMA GLOBAL INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 001-39311 85-0800493

(State or other jurisdiction

 of incorporation)

(Commission

 File Number)

(I.R.S. Employer

Identification No.)

     

4850 West 78th Street,

Indianapolis, IN

46268
(Address of principal executive offices) (Zip Code)
       


(647) 812-2417

Registrant’s telephone number, including area code

 

(Former name or former address, if changed since last report)

_______________________

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common stock, par value $0.0001 per share PNT The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934. 

Emerging growth company x 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

  

Item 2.02 Results of Operations and Financial Condition.

 

On August 13, 2021, POINT Biopharma Global Inc. issued a press release announcing financial results for the quarter ended June 30, 2021. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information contained in this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit Number Description
99.1 Press Release by POINT Biopharma Global Inc. dated August 13, 2021

 

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SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

  

Dated: August 13, 2021 POINT BIOPHARMA GLOBAL INC.  
   
  By: /s/ Bill Demers
  Name:   Bill Demers
  Title: Chief Financial Officer

 

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Exhibit 99.1

 

POINT Biopharma Reports Second Quarter 2021 Financial Results and Provides Business Update

 

Strengthened the Company’s balance sheet by completing the business combination with Therapeutics Acquisition Corp (“RACA”), with gross proceeds from the transaction totaling approximately $286.7 million

Completion of enrollment of the 25-patient safety and dosimetry lead-in in the Phase 3 SPLASH study to evaluate the efficacy of PNT2002 in patients with mCRPC

 

August 13, 2021 – INDIANAPOLIS, INDIANA – 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, 2021 and provided a business update.

 

“During Q2 2021, POINT listed on NASDAQ and now has $273.7 million of cash to transform POINT into a global radioligand leader,” said Dr. Joe McCann, Chief Executive Officer of POINT. "The Phase 3 trial of POINT’s lead product, PNT2002 for metastatic castration resistant prostate cancer, is progressing ahead of schedule, with patient enrollment of its safety and dosimetry lead-in completed early. PNT2002 is complemented by a healthy portfolio of other radioligands also focused on oncological indications.”

 

Recent Developments and Upcoming Milestones

 

Pipeline Updates

 

PNT2002: PNT2002 is the Company’s investigational 177Lu-PSMA targeted radioligand therapy. In August 2021, the Company announced the completion of enrollment of the 25-patient safety and dosimetry lead-in in the Phase 3 SPLASH study to evaluate the efficacy of PNT2002 in patients with mCRPC who have progressed on ARAT therapy and refuse or not eligible for chemotherapy. The study is a multi-center, randomized open label assessment of PNT2002 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). The Company expects to report top-line data from the SPLASH study in mid-2023.

  

PNT2003: PNT2003 is a somatostatin-targeted radioligand therapy. The Company, through it’s 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). The Company expects to report data from this study in the first half of 2022.

 

PNT2001: PNT2001 is a family of next-generation PSMA radioligands being developed for the treatment of prostate cancer. PNT2001 compounds are designed to include a linker technology that promotes increased tumor accumulation, potentially enabling lower doses of radioisotope to be used to induce a similar level of tumor killing while reducing the risk of off target toxicity. The Company expects to advance a single compound from the family and initiate IND-enabling studies for this program in 2022.

 

PNT2004: PNT2004 is a FAP-α targeted radioligand in preclinical development for the treatment of solid tumors. FAP-α is highly expressed on a wide range of solid tumors but absent in all other healthy tissues, offering the potential for a tumor agnostic therapy that could enable the precise treatment of a variety of solid tumors independent of tissue origin. POINT is continuing preclinical studies and expects to initiate clinical development for this program in 2022.

 

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Tumor Microenvironment (TME) Targeting Technology: POINT’s FAP-α activated prodrug technology attempts to limit a ligand’s ability to bind with receptors on healthy cells, to prevent off-target delivery and improve therapeutic index. Currently in the pre-clinical stage, POINT’s TME Targeting Technology is sub-licensed from Avacta, who has named it pre | CISION™ (an Avacta trademark).

 

Corporate Updates:

 

Successfully closed business combination with Therapeutics Acquisition Corp., d/b/a Research Alliance Corp. I transitioning to a public company: The business combination, and concurrent PIPE financing, which closed in June 2021, resulted in gross proceeds to POINT of approximately $286.7 million. POINT now trades on the NASDAQ exchange under the ticker PNT.

 

Strengthened Executive Leadership Team: In June 2021, POINT appointed Dr. Myra Herrle, Ph.D., R.Ph., RAC to the Company’s leadership team as Executive Vice President of Regulatory Affairs. Dr. Herrle brings over 27 years of experience in the pharmaceutical industry in areas such as regulatory affairs and product development and will play a key role in registration strategy for both the Company’s early-stage programs and two ongoing Phase 3 trials of PNT2002 and PNT2003.

 

Manufacturing: In April 2021, POINT received a Materials License from the U.S. Nuclear Regulatory Commission (NRC) for the Company’s new radiopharmaceutical manufacturing facility located in Indianapolis, Indiana. This facility is on track to open in the second half of this year and will initially be used to provide supply for POINT’s Phase 3 SPLASH study.

 

Second Quarter 2021 Financial Results

 

Net Loss: Net loss was $ 8.8 million, or $0.15 net loss per share, for the quarter ended June 30, 2021, as compared to a net loss of $3.2 million, or $0.07 net loss per share, for the same period in 2020.

 

Research and Development Expenses: Research and development expenses were $ 6.7 million for the quarter ended June 30, 2021, as compared to $ 2.2 million for the same period in 2020, an increase of approximately 210.3%. The increase in research and development expense was primarily due to increases in (a) costs associated with our licensing agreements and related sponsored research in connection with our product candidates both pre-clinical and clinical, (b) costs incurred in clinical trials, including manufacturing and development of product candidates, (c) increased personnel costs as the Company continues to expand its research and development headcount and (d) regulatory consulting fees that are required to further advance the development of our product candidates as we advance our pipeline and grow the organization.

 

General and Administrative Expenses: General and administrative expenses were $ 1.9 million for the quarter ended June 30, 2021, as compared to $ 1.1 million for the same period in 2020, an increase of approximately 82.7%. The increase in general and administrative expenses was primarily due to increased (a) costs associated with legal fees relating to corporate and patent matters as well as costs incurred in relation to becoming a publicly traded company, (b) professional fees incurred for accounting, auditing, and tax, each increasing primarily in preparation of becoming a publicly traded company and (c) insurance, administrative consulting services, advertising, office expenses and other facilities expenses as the Company continues to increase the scale of its operations.

 

Cash and Cash Equivalents: As of June 30, 2021, POINT had approximately $273.7 million in cash and cash equivalents.

 

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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 Biopharma Global Inc. is combining a portfolio of best-in-class radiopharmaceutical assets, a seasoned management team, expertise in radioisotopes such as Actinium-225 (Ac-225) and Lutetium-177 (Lu-177), manufacturing technology and novel direct-to-patient targeting to revolutionize theragnostic drug development and radioligand commercialization. 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.

 

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 RACA’s definitive proxy statement filed with the SEC on June 9, 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

VP, Corporate Affairs
media@pointbiopharma.com
(647) 812-2417

 

Investor Relations Contact:

Alex Lobo

Stern Investor Relations

investors@pointbiopharma.com

 

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Unaudited Interim Condensed Consolidated Statements of Operations

 

(In U.S. dollars)

    For the three months ended     For the six months ended  
    June 30,
2021
    June 30,
2020
   

June 30,

2021

    June 30,
2020
 
       $        $        $        $  
Operating expenses                                
Research and development     6,700,862       2,159,322       10,970,160       2,544,916  
General and administrative     1,949,552       1,067,333       3,414,244       2,090,997  
Total operating expenses     8,650,414       3,226,655       14,384,404       4,635,913  
Loss from operations     (8,650,414 )     (3,226,655 )     (14,384,404 )     (4,635,913 )
                                 
Other expenses (income)                                
Finance costs     (2,863 )           (5,662 )      
Foreign currency (loss) gain     (27,599 )     92,919       (34,806 )     (65,413 )
Total other expenses (income)     (30,462 )     92,919       (40,468 )     (65,413 )
                                 
Loss before provision for income taxes     (8,680,876 )     (3,133,736 )     (14,424,872 )     (4,701,326 )
Provision for income taxes     (123,782 )     (58,261 )     (164,207 )     (73,505 )
Net loss     (8,804,658 )     (3,191,997 )     (14,589,079 )     (4,774,831 )
                                 
Net loss per basic and diluted common share:                                
Basic and diluted net loss per common share   $ (0.15 )   $ (0.07 )   $ (0.26 )   $ (0.21 )
Basic and diluted weighted average common shares outstanding     57,582,025       45,362,014       57,116,747       22,986,636  

                    

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Interim Condensed Consolidated Balance Sheets

 

(In U.S. dollars)

    June 30, 2021
(Unaudited)
    December 31, 2020  
    $     $  
ASSETS                
Current assets                
Cash and cash equivalents     273,736,820       10,546,749  
Prepaid expenses and other current assets     8,071,586       1,850,346  
Total current assets     281,808,406       12,397,095  
                 
Property, plant and equipment     15,654,223       9,797,400  
Total assets     297,462,629       22,194,495  
                 
LIABILITIES & STOCKHOLDERS' EQUITY                
Current labilities                
Accounts payable     5,018,089       3,596,634  
Accrued liabilities     3,145,807       1,479,041  
Income taxes payable     189,370       87,882  
Mortgage payable, net of debt discount     3,556,322        
Total current liabilities     11,909,588       5,163,557  
                 
Deferred tax liability     62,719        
Mortgage payable, net of debt discount           3,550,660  
Total liabilities     11,972,307       8,714,217  
                 
Commitment and contingencies (note 10)                
                 
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 June 30, 2021 and December 31, 2020, respectively     9,012       5,465  
Additional paid-in capital     313,452,616       26,857,040  
Accumulated deficit     (27,971,306 )     (13,382,227 )
Total stockholders' equity     285,490,322       13,480,278  
                 
Total liabilities and stockholders' equity     297,462,629       22,194,495  

 

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Unaudited Interim Condensed Consolidated Statements of Cash Flows

 

(In U.S. dollars)

    For the six months ended  
    June 30, 2021     June 30, 2020  
       $        $  
Cash flows from operating activities                
Net loss:     (14,589,079 )     (4,774,831 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Provision for income taxes     164,207       73,505  
Stock-based compensation expense     1,583,702       1,215,051  
Finance costs     5,662        
Changes in operating assets and liabilities                
Prepaid expenses and other current assets     (6,221,240 )     (1,473,921 )
Accounts payable     1,043,073       271,388  
Accrued liabilities     1,149,742       331,159  
Amount due to related party within accrued liabilities     33,910       150,291  
Net cash used in operating activities     (16,830,023 )     (4,207,358 )
                 
Cash flows from investing activities                
Purchase of property, plant and equipment     (5,856,823 )      
Net cash used in investing activities     (5,856,823 )      
                 
Cash flows from financing activities                
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       11,253,754  
Issuance of shares of Common Stock in connection with the business combination, net of costs incurred by RACA and direct and incremental costs paid     265,426,917        
Net cash provided by financing activities     285,876,917       11,253,754  
                 
Net increase in cash and cash equivalents     263,190,071       7,046,396  
Cash and cash equivalents, beginning of period     10,546,749        
Cash and cash equivalents, end of period     273,736,820       7,046,396  

 

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