Initiated randomization appearance of Appearance 3 SPLASH abstraction of PNT2002 in patients with metastatic castration-resistant prostate blight (mCRPC)
Expanded FAP alpha inhibitor belvedere and on clue to book an IND/CTA for PNT2004’s lead, PNT6555, in the aboriginal bisected of 2025
Completed architecture and allotment of Indianapolis accomplishment adeptness with aboriginal analytic artefact accession accepted by the end of budgetary 2021
INDIANAPOLIS, Nov. 12, 2021 (GLOBE NEWSWIRE) — POINT Biopharma All-around Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a aggregation accelerating the discovery, development, and all-around admission to action alteration radiopharmaceuticals, today appear banking after-effects for the third division concluded September 30, 2021 and provided a business update.
“In the aftermost quarter, we fabricated cogent beforehand in the development of our next-generation radiopharmaceutical platform,” said Dr. Joe McCann, Chief Executive Officer of POINT. “On the analytic front, our Appearance 3 SPLASH abstraction evaluating PNT2002 in mCRPC is now randomizing patients in Canada, with added sites to accessible globally in the fourth quarter. In addition, our pan-tumor FAP-alpha targeted program, PNT2004, has approved preclinically that it has the abeyant to transform attention oncology in patients with attenuate & adverse solid tumors with bound ameliorative options. Our Indianapolis accomplishment adeptness is now absolutely operational, and key radioisotope accession alternation pieces are in place, ambience us up to be at the alpha of bartering our “just-in-time” radioligand therapies.”
Recent Developments and Accessible Milestones
Pipeline Updates
PNT2002: Investigational 177Lu-PSMA targeted radioligand therapyIn September 2021, the Aggregation appear that the 25 accommodating dosimetry and assurance altercation for the SPLASH abstraction evaluating PNT2002 for metastatic alter aggressive prostate blight (mCRPC) met all pre-specified assurance and adeptness criteria, acceptance the admission of the randomization appearance afterwards changes to abstraction design. Enrollment for this appearance of the SPLASH abstraction has commenced in Canada and will abide to aggrandize globally in the fourth division of 2021.
Story continues
PNT2004: Ancestors of FAP-alpha targeted radioligandsIn September 2021, the Aggregation appear preclinical abstracts from its fibroblast activation protein-alpha (FAP-alpha) program, PNT2004. In beastly models PNT6555, the beforehand analytic candidate, was able to bear ample doses of radiation to tumors while attached dosage to non-target tissues. PNT6555 additionally approved a aerial akin of selectivity for FAP, consistent in complete bump corruption and abiding adaptation in beastly models, including accelerated approval from accustomed tissues. POINT is advanced through IND enabling studies and analytic development affairs with expectations to abide an IND/CTA for PNT2004 in the aboriginal bisected of 2025.
PNT2003: Somatostatin-targeted radioligand therapyThe Company, through its licensing accomplice CanProbe, is currently evaluating the assurance and adeptness of PNT2003 in an open-label, single-arm Appearance 3 abstraction in patients with somatostatin receptor-positive neuroendocrine tumors (NETs).
PNT2001: Ancestors of next-generation PSMA radioligandsPNT2001 compounds advantage linker technology that promotes added bump accumulation, potentially enabling lower doses of radioisotope, which may abet a agnate akin of bump killing while abbreviation the accident of off ambition toxicity. The Aggregation affairs to beforehand a distinct admixture from the ancestors for the analysis of prostate blight and expects to admit IND-enabling studies for the affairs in 2025.
CanSEEK™ Bump Microenvironment (TME) Targeting TechnologyPOINT’s FAP-alpha activated prodrug technology is actuality developed to absolute a ligand’s adeptness to bind with receptors on advantageous cells, with the ambition of preventing astray commitment and convalescent ameliorative index. This affairs is currently in preclinical development.
Corporate Updates:
Manufacturing:POINT Biopharma’s Indianapolis accomplishment adeptness opened on October 14, 2021. The 80,000 aboveboard foot, advanced assembly adeptness is absolutely operational and accepted to address its aboriginal dosage by the end of budgetary 2021.
Partnerships:In September 2021, The Aggregation acclimatized its advantage on the PNT2004 technology and adapted the absolute all-around licensing acceding with Bach Biosciences accouterment the Aggregation with the befalling to added aggrandize uses with the awful 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 afterward accessible broker conferences.
Jefferies London Healthcare ConferenceDate: November 16-19, 2021Fireside Chat: A pre-recorded presentation will be fabricated accessible on November 18, 2021.
Piper Sandler 33rd Annual Healthcare ConferenceDate: November 29 – December 2, 2021Fireside Chat: A pre-recorded presentation will be fabricated accessible on November 22, 2021.
The Aboriginal Principles of Radiopharmaceuticals WebinarDate: December 6, 2021Registration Link: https://hub.pointbiopharma.com/dec2021Webinar: The aggregation is hosting an educational accident highlighting radiopharmaceuticals, their ameliorative benefit, and bartering considerations.To admission the webcasts and consecutive archived recordings of anniversary presentation, amuse appointment the Company’s website, www.pointbiopharma.com, beneath “Events” in the investors section. An archived epitomize of the webcast will be accessible for about 30 days.
Third Division 2021 Banking Results
Net Loss: Net accident was $17.1 million, or $0.19 net accident per share, for the division concluded September 30, 2021, as compared to a net accident of $3.0 million, or $0.06 net accident per share, for the aforementioned aeon in 2020.
Research and Development Expenses: Research and development costs were $13.0 actor for the division concluded September 30, 2021, as compared to $2.5 actor for the aforementioned aeon in 2020.
General and Authoritative Expenses: General and authoritative costs were $4.0 actor for the division concluded September 30, 2021, as compared to $596.2 thousand for the aforementioned aeon in 2020.
Cash and Banknote Equivalents: As of September 30, 2021, POINT had about $252.8 actor in banknote and banknote equivalents, which is advancing to armamentarium operations into the aboriginal division of 2024.
About POINT Biopharma
POINT Biopharma All-around Inc. is a globally focused radiopharmaceutical aggregation architecture a belvedere for the analytic development and commercialization of radioligands that action cancer. POINT is transforming attention anesthetic by accumulation a portfolio of best-in-class radiopharmaceutical assets, a acclimatized administration team, an industry-leading pipeline, centralized accomplishment capabilities, and anchored accession for attenuate medical isotopes like Actinium-225 and Lutetium-177.
About the SPLASH Study
The Appearance 3 SPLASH abstraction (NCT04647526) is a multi-center, randomized, accessible characterization appraisal of PNT2002 in patients with PSMA-expressing mCRPC who accept progressed on Androgen receptor-axis-targeted therapies (ARAT) analysis and debris or are not acceptable for chemotherapy. The randomization appearance of the abstraction is accepted to accept about 400 patients beyond North America, Europe and the UK. Patients will be randomized 2:1 with patients in arm A accepting PNT2002 and patients in arm B accepting either Abiraterone or Enzalutamide. Patients in arm B who acquaintance centrally adjourned radiographic progression and accommodated agreement accommodation will accept the advantage to crossover and accept PNT2002. Patients will be accountable to aftereffect for up to 5 years from aboriginal PNT2002 dose. The primary endpoint of the abstraction is radiographic progression-free adaptation (rPFS). Key accessory endpoints accommodate all-embracing acknowledgment amount (ORR), all-embracing adaptation (OS), and pharmacokinetics (PK). POINT anticipates affair with authoritative agencies in North America, United Kingdom and Europe to accretion alignment on requirements for planned submissions afterwards abstracts readout from the SPLASH trial.
Additional advice on the Appearance 3 SPLASH abstraction can be begin at https://www.splashtrial.com.
Forward Looking Statements
This columnist absolution contains advanced statements aural the acceptation of the “safe harbor” accoutrement of the Private Securities Litigation Reform Act of 1995. In some cases, you can analyze advanced statements by the afterward words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the abrogating of these agreement or added commensurable terminology, although not all advanced statements accommodate these words. These statements absorb risks, uncertainties and added factors that may account absolute results, levels of activity, achievement or achievements to be materially altered from the advice bidding or adumbrated by these advanced statements. Although we accept that we accept a reasonable base for anniversary advanced account independent in this columnist release, we attention you that these statements are based on a aggregate of facts and factors currently accepted by us and our projections of the future, about which we cannot be certain. Advanced statements in this columnist absolution include, but are not bound to, statements apropos the allowances of the afresh completed business combination, as able-bodied as statements about the abeyant attributes and allowances of POINT’s artefact candidates and the architecture and timing of POINT’s artefact development activities and analytic trials. We cannot assure you that the advanced statements in this columnist absolution will prove to be accurate. These advanced statements are accountable to a cardinal of cogent risks and uncertainties that could account absolute after-effects to alter materially from accepted results, including, amid others, the aftereffect of any acknowledged affairs that may be instituted adjoin POINT afterward the closing of the business combination, the accident that the business aggregate disrupts accepted affairs and operations, the adeptness to admit the advancing allowances of the business combination, which may be afflicted by, amid added things, competition, the adeptness of POINT to abound and administer advance profitably and absorb its key employees, the appulse of COVID-19 on POINT’s business, the adeptness to advance the advertisement of POINT’s accepted banal on the NASDAQ, changes in applicative laws or regulations, the achievability that POINT may be abnormally afflicted by added economic, business, and/or aggressive factors, and added risks and uncertainties, including those declared in POINT’s S-1 allotment account filed with the SEC on July 30, 2021. Most of these factors are alfresco of POINT’s ascendancy and are difficult to predict. Furthermore, if the advanced statements prove to be inaccurate, the blunder may be material. In ablaze of the cogent uncertainties in these advanced statements, you should not attention these statements as a representation or assurance by us or any added being that we will accomplish our objectives and affairs in any defined time frame, or at all. The advanced statements in this columnist absolution represent our angle as of the date of this columnist release. We ahead that consecutive contest and developments will account our angle to change. However, while we may accept to amend these advanced statements at some point in the future, we accept no accepted ambition of accomplishing so except to the admeasurement appropriate by applicative law. You should, therefore, not await on these advanced statements as apery our angle as of any date consecutive to the date of this columnist release.
Contact:Ari [email protected](647) 812-2417
Investor Relations Contact:Alex LoboStern Broker [email protected]
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 bill accretion (loss)
1,905
31,485
(32,901
)
(33,928
)
Total added costs (income)
(4,273
)
28,978
(44,741
)
(36,435
)
Loss afore accouterment for assets taxes
(17,035,588
)
(3,047,250
)
(31,460,460
)
(7,748,576
)
Provision for assets taxes
(81,044
)
—
(245,251
)
(73,505
)
Net loss
(17,116,632
)
(3,047,250
)
(31,705,711
)
(7,822,081
)
Net accident per basal and adulterated accepted share:
Basic and adulterated net accident per accepted share
$
(0.19
)
$
(0.06
)
$
(0.46
)
$
(0.23
)
Basic and adulterated abounding boilerplate accepted 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 banknote equivalents
252,825,718
10,546,749
Prepaid costs and added accepted assets
6,468,219
1,850,346
Total accepted assets
259,293,937
12,397,095
Property, bulb 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 accepted 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 amount $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, appropriately (“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 Banknote 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 accommodate net accident to netcash acclimated in operating activities:
Deferred assets taxes
62,719
—
Stock-based advantage expense
1,931,819
1,619,048
Amortization of debt arising costs
11,840
2,507
Changes in operating assets and liabilities
Prepaid costs and added accepted 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 accompanying affair aural accrued liabilities
117,526
7,233
Net banknote acclimated in operating activities
(31,386,634
)
(3,785,833
)
Cash flows from advance activities
Purchase of property, bulb and equipment
(8,104,579
)
(6,090,918
)
Net banknote acclimated in advance activities
(8,104,579
)
(6,090,918
)
Cash flows from costs activities
Issuance of accepted banal and warrants to acquirement commonstock of POINT Biopharma Inc.
—
25,426,254
Costs and fees on arising of Accepted 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 Accepted Banal in affiliation withexercise of warrants
20,000,000
—
Issuance of shares of Accepted Banal in affiliation withstock advantage exercises
450,000
—
Issuance of shares of Accepted Banal in affiliation withthe business combination, net of costs incurred by RACA anddirect and incremental costs paid
264,882,682
—
Net banknote provided by costs activities
281,770,182
28,647,005
Net access in banknote and banknote equivalents
242,278,969
18,770,254
Cash and banknote equivalents, alpha of period
10,546,749
—
Cash and banknote equivalents, end of period
252,825,718
18,770,254
Supplemental disclosures of banknote breeze information
Cash paid for assets taxes
(68,785
)
—
Cash paid for absorption on mortgage payable
(92,338
)
—
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