POINT Biopharma Reports Third Quarter 2023 Financial Results and Provides Business Highlights

INDIANAPOLIS, Nov. 13, 2023 (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, 2023, and provided a business update.

"The founding mission of our company is to accelerate the discovery, development and global access to radiopharmaceuticals," said Joe McCann, Ph.D., CEO of POINT Biopharma. "I view Lilly's agreement to acquire POINT as validation of the uniqueness of our team, infrastructure and pipeline. Together, we can become a global radiopharmaceutical leader, executing on our mission and transforming lives touched by cancer."

POINT to be Acquired by Lilly

On October 3, 2023, Eli Lilly and Company (NYSE:LLY) and POINT Biopharma Global Inc. (NASDAQ:PNT) announced a definitive agreement for Lilly to acquire POINT for a purchase price of $12.50 per share in cash (an aggregate of approximately $1.4 billion) payable at closing. The purchase price payable at closing represents a premium of approximately 87% to POINT's closing stock price on Oct. 2, 2023, the last trading day before the announcement of the transaction, and 68% to the 30-day volume-weighted average price. The tender offer, which was previously scheduled to expire at one minute past 11:59 p.m., Eastern time, on Nov. 9, 2023, has been extended until 5:00 p.m., Eastern time, on Nov. 16, 2023, unless the tender offer is further extended or earlier terminated, in order for the parties to satisfy outstanding closing conditions. The proposed acquisition is expected to close near the end of 2023, subject to customary closing conditions, including the tender of at least a majority of the outstanding Shares as of the expiration of the tender offer.

Business Highlights and Upcoming Milestones

Pipeline Updates

PNT2002: ¹⁷⁷Lu-labelled PSMA-targeted radioligand therapy

Enrollment in PNT2002's phase 3 SPLASH trial (NCT04647526) is complete and topline data is expected in the fourth quarter of 2023.

PNT2004: fibroblast activation protein-α (FAP-α) targeted radioligand therapy

The PNT2004 program leverages the D-ala-boroPro FAP targeting warhead, which is a potent and selective FAP inhibitor. PNT6555 is the current clinical lead in the PNT2004 program.

The phase 1 FRONTIER trial (NCT05432193) utilizing ⁶⁸Ga/¹⁷⁷Lu-labelled PNT6555 closed enrollment after the dosing of cohort 3 (12 GBq) in October. There are no plans for expansion of the third cohort, and there were no dose limiting toxicities. Analysis of the dosimetry and clinical data from the FRONTIER trial is underway and includes pancreatic ductal adenocarcinoma, colorectal cancer, cholangiocarcinoma, and esophageal cancer subjects.

Presentation of data from the FRONTIER study is anticipated in the first half of 2024, and based on initial promising data we expect to advance at least one 2nd-generation D-ala-boroPro-based lead into the clinic next year.

PNT2001: ²²⁵Ac-labelled next-generation PSMA-targeted radioligand therapy

For the phase 1 portion of ACCEL, the first-in-human phase 1/2 clinical trial for PNT2001's actinium-225 program, we expect the first patient dosed in this trial to be in the first quarter of 2024. The trial was designed to enable the parallel exploration of PNT2001 in two populations: patients with later-stage mCRPC and patients with earlier-stage BCR or PSMA-positive oligorecurrent disease.

Manufacturing & Supply Chain Updates

In July 2023, we announced an expanded agreement with ITM Isotope Technologies Munich SE (ITM), which broadens the supply of ITM's no-carrier-added lutetium-177 (n.c.a. ¹⁷⁷Lu) to POINT to enable its usage in the clinical and potential future commercial development of the ¹⁷⁷Lu-based molecules in POINT's development pipeline.

In September 2023, we signed a supply agreement with Eckert & Ziegler AG for no-carrier-added lutetium-177 (n.c.a. ¹⁷⁷Lu).

Discovery Updates

In September 2023, we announced a collaboration and license agreement to develop and commercialize DARPin-targeted radioligands ("Radio-DARPins"). The collaboration gives POINT exclusive access to Athebio's intellectual property and capabilities in DARPin development in the radioligand therapy field. Together, the parties will collaborate in discovery, candidate selection and preclinical development of Athebody^® DARPins for use as Radio-DARPin drug entities. POINT will be solely responsible for the clinical development and commercialization of Radio-DARPins translated from the discovery collaboration.

Third Quarter 2023 Financial Results

Cash, Cash Equivalents, and Investments: As of September 30, 2023, POINT had approximately $399.0 million in cash, cash equivalents, and investments, which is anticipated to fund operations into 2026.

Net Loss: Net loss was $24.8 million and $66.7 million, or $0.23 and $0.63 net loss per share, for the three and nine months ended September 30, 2023, respectively, as compared to a net loss of $24.0 million and $65.0 million, or $0.26 and $0.71 net loss per share, respectively, for the same periods in 2022.

Research and Development Expenses: Research and development expenses were $26.9 million and $85.1 million for the three and nine months ended September 30, 2023, respectively, as compared to $20.8 million and $54.1 million, respectively, for the same periods in 2022.

General and Administrative Expenses: General and administrative expenses were $5.5 million and $15.6 million for the three and nine months ended September 30, 2023, respectively, as compared to $3.8 million and $11.7 million for the same periods in 2022.

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 oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT's active clinical trials include FRONTIER, a 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. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com/.

Additional Information and Where to Find it

In connection with the proposed acquisition of POINT, Eli Lilly and Company ("Lilly") caused its acquisition subsidiary to commence a tender offer for all of the issued and outstanding shares of common stock of POINT. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any securities, nor is it a substitute for the tender offer materials that Lilly and its acquisition subsidiary filed with the SEC upon commencement of the tender offer. A solicitation and offer to buy outstanding shares of POINT is being made only pursuant to the tender offer materials that Lilly and its acquisition subsidiary have filed with the SEC. Lilly and its acquisition subsidiary have filed with the SEC a tender offer statement on Schedule TO, and POINT has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO. INVESTORS AND STOCKHOLDERS OF POINT ARE URGED TO READ THESE DOCUMENTS CAREFULLY (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND STOCKHOLDERS OF POINT SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES OF COMMON STOCK IN THE TENDER OFFER. The tender offer materials (including the Offer to Purchase and the related Letter of Transmittal) are available to all stockholders of POINT at no expense to them at Lilly's website at investor.lilly.com. The information contained in, or that can be accessed through, Lilly's website is not a part of, or incorporated by reference in, this press release. The tender offer materials (including the Offer to Purchase and the related Letter of Transmittal), as well as the Solicitation/Recommendation Statement, are also available for free on the SEC's website at www.sec.gov. In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Lilly and POINT file annual, quarterly, and current reports, proxy statements and other information with the SEC. You may read any reports, statements or other information filed by Lilly and POINT with the SEC for free on the SEC's website at www.sec.gov.

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, the format and timing of POINT's product development activities and clinical trials, and timing of the closing of the proposed acquisition. 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, that there can be no guarantee that the proposed acquisition will be completed in the anticipated timeframe or at all, that the conditions required to complete the proposed acquisition will be met, that any event, change or other circumstance that could give rise to the termination of the definitive agreement for the proposed acquisition will not occur, 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 27, 2023 and our quarterly report on Form 10-Q filed with the SEC on November 13, 2023. 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

Director, Strategy

[email protected]

Unaudited Interim Condensed Consolidated Statements of Operations

(In U.S. dollars, except for share amounts)

		For the Three Months Ended September 30,								For the Nine Months Ended September 30,
			2023				2022				2023				2022
Revenue		$	2,789,993			$	—			$	17,113,113			$	—
Operating expenses:
Research and development			26,910,286				20,797,406				85,097,331				54,112,136
General and administrative			5,505,869				3,839,626				15,604,401				11,727,969
Total operating expenses			32,416,155				24,637,032				100,701,732				65,840,105
Loss from operations			(29,626,162	)			(24,637,032	)			(83,588,619	)			(65,840,105	)
Other income (expenses)			5,723,258				804,463				16,584,265				1,318,236
Loss before income taxes			(23,902,904	)			(23,832,569	)			(67,004,354	)			(64,521,869	)
Income tax (provision) benefit			(871,449	)			(180,500	)			288,491				(452,021	)
Net loss		$	(24,774,353	)		$	(24,013,069	)		$	(66,715,863	)		$	(64,973,890	)
Net loss per basic and diluted common share:
Basic and diluted net loss per common share		$	(0.23	)		$	(0.26	)		$	(0.63	)		$	(0.71	)
Basic and diluted weighted average common shares outstanding			105,765,954				92,401,484				105,717,330				90,891,031

Interim Condensed Consolidated Balance Sheets

(In U.S. dollars)

	As at September 30, 2023 (Unaudited)				As at December 31, 2022
Assets
Cash, cash equivalents and investments	$	398,956,509			$	541,331,271
Other assets		78,747,911				36,991,465
Total assets	$	477,704,420			$	578,322,736
Liabilities and Stockholders' Equity
Liabilities	$	53,512,034			$	91,368,943
Stockholders' equity		424,192,386				486,953,793
Total liabilities and stockholders' equity	$	477,704,420			$	578,322,736