UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

SCHEDULE 14D-9

(Rule 14d-101)

(Amendment No. 7)

Solicitation/Recommendation Statement

Under Section 14(d)(4) of the Securities Exchange Act of 1934

 

 

POINT Biopharma Global Inc.

(Name of Subject Company)

 

 

POINT Biopharma Global Inc.

(Name of Persons Filing Statement)

 

 

Common Stock, par value $0.0001 per share

(Title of Class of Securities)

730541109

(CUSIP Number of Class of Securities)

Joe McCann

Chief Executive Officer

4850 West 78th Street

Indianapolis, IN

(317) 543-9957

(Name, address, and telephone numbers of person authorized to receive notices and communications

on behalf of the persons filing statement)

With copies to:

 

Graham Robinson

Chadé Severin

Skadden, Arps, Slate, Meagher & Flom LLP

500 Boylston Street, 23rd Floor

Boston, Massachusetts 02116

(617) 573-4800

 

 

 

Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.

 

 

 


This Amendment No. 7 (this “Amendment”) amends and supplements the Solicitation/Recommendation Statement on Schedule 14D-9 (as amended or supplemented from time to time, the “Schedule 14D-9”) filed by POINT Biopharma Global Inc., a Delaware corporation (“POINT”) with the Securities and Exchange Commission on October 13, 2023, relating to the tender offer by Yosemite Falls Acquisition Corporation, a Delaware corporation (“Purchaser”) and a wholly owned subsidiary of Eli Lilly and Company, an Indiana corporation (“Lilly”), to purchase all of the issued and outstanding shares of common stock of POINT, par value $0.0001 per share (the “Shares”), at a purchase price of $12.50 per Share, net to the stockholder in cash, without interest, and less any applicable tax withholding, on the terms and subject to the conditions set forth in the Offer to Purchase, dated as of October 13, 2023 (as amended or supplemented from time to time) and the related Letter of Transmittal (as amended or supplemented from time to time), and pursuant to the Agreement and Plan of Merger, dated as of October 2, 2023, by and among Lilly, Purchaser and POINT.

Except to the extent specifically provided in this Amendment, the information set forth in the Schedule 14D-9 remains unchanged. Capitalized terms used but not otherwise defined in this Amendment shall have the meanings ascribed to them in the Schedule 14D-9. This Amendment No. 7 is being filed to reflect certain updates as set forth below.

ITEM 2. IDENTITY AND BACKGROUND OF FILING PERSON

Item 2 of the Schedule 14D-9 is hereby amended and supplemented as follows:

 

  1.

By adding the bold and underlined text and deleting the struck through text to the below paragraph under the subsection titled “Tender Offer” on page 3 as follows:

“Purchaser commenced (within the meaning of Rule 14d-2 promulgated under the Exchange Act) the Offer on October 13, 2023. The Offer was initially scheduled to expire at one minute after 11:59 p.m., Eastern Time, on November 9, 2023. On November 8, 2023, the Offer was extended until 5:00 p.m., Eastern Time, on November 16, 2023. On November 17, 2023, the Offer was extended until 5:00 p.m., Eastern Time, on December 1, 2023. On December 4, 2023, the Offer was extended until 5:00 p.m., Eastern Time, on December 15, 2023. On December 18, 2023, Lilly announced a further extension of the Offer until 5:00 p.m., Eastern Time, on December 15 December 22, 2023 (the “Expiration Time”), unless the expiration of the Offer is extended to a subsequent date in accordance with the terms of the Merger Agreement, in which case the term “Expiration Time” means such subsequent time on such subsequent date. The depositary has advised Purchaser that, as of 5:00 p.m., Eastern Time, on December 1 December 15, 2023, approximately 26,374,912 24,338,647 Shares had been validly tendered into and not properly withdrawn pursuant to the Offer, representing approximately 24.75% 22.81% of the outstanding Shares. If at the scheduled Expiration Time any of the conditions to the Offer (other than the Minimum Tender Condition) have not been satisfied or waived, Purchaser shall, and Lilly shall cause Purchaser to, extend the Offer for one or more consecutive increments of not more than 10 business days each (or such longer period as may be agreed to by Lilly and POINT), until such time as such conditions have been satisfied or waived. Purchaser shall, and Lilly shall cause Purchaser to, extend the Offer for the minimum period required by any rule, regulation, interpretation or position of the SEC or the staff thereof or The Nasdaq Capital Market, in each case that are applicable to the Offer. In addition, if at the scheduled Expiration Time, each condition to the Offer (other than the Minimum Tender Condition) shall have been satisfied or waived and the Minimum Tender Condition shall not have been satisfied, Purchaser may elect to (and if so requested by POINT, Purchaser shall, and Lilly shall cause Purchaser to), extend the Offer for one or more consecutive increments of such duration as requested by POINT (or if not so requested by POINT, as determined by Lilly), but not more than 10 business days each (or for such longer period as may be agreed to by Lilly and POINT), provided that POINT shall not request Purchaser to, and Lilly shall not be required to cause Purchaser to, extend the Offer pursuant to this sentence on more than five occasions. In no event will Purchaser be required to extend the Offer beyond one minute after 11:59 p.m., Eastern Time, on July 2, 2024 (the “Outside Date”), provided that the Outside Date may be extended once by a period of 90 days, if on the Outside Date all of the Offer Conditions have been satisfied or waived by Lilly or Purchaser (other than conditions that by their nature are to be satisfied at the Acceptance Time, each of which is then capable of being satisfied), other than the Antitrust Condition, the NRC Condition and the condition requiring the absence of any Legal Restraint by any Specified Governmental Entity preventing or prohibiting the consummation of the Offer or the Merger.”

 

2


ITEM 8. ADDITIONAL INFORMATION

Item 8 of the Schedule 14D-9 is hereby amended and supplemented as follows:

 

  1.

By adding the following new subsection and paragraph immediately following the end of the subsection titled “Legal Proceedings” on page 44 as follows:

“SPLASH Clinical Trial Topline Data Announcement

On December 18, 2023, POINT and Lantheus announced topline results of the SPLASH Clinical Trial. A copy of the press release announcing the results is filed as Exhibit (a)(5)(N) to this Schedule 14D-9.”

 

3


ITEM 9. EXHIBITS

 

  1.

Item 9 is hereby amended and supplemented by adding the following exhibits:

 

Exhibit No.

 

Description

(a)(5)(N)   Joint Press Release issued by POINT and Lantheus on December 18, 2023.
(a)(5)(O)   Press Release issued by Lilly on December 18, 2023 (incorporated by reference to Exhibit (a)(5)(F) to the Schedule TO).

 

4


SIGNATURE

After due inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true, complete and correct.

Date: December 18, 2023

 

POINT Biopharma Global Inc.
By:  

/s/ Bill Demers

  Name:   Bill Demers
  Title:   Chief Financial Officer

Exhibit (a)(5)(N)

 

LOGO   LOGO

Lantheus and POINT Biopharma Announce Positive Topline Results from Pivotal SPLASH Trial in Metastatic Castration-Resistant Prostate Cancer

Phase 3 SPLASH study of 177Lu-PNT2002 demonstrated statistically significant improvement in radiographic progression-free survival (rPFS)

BEDFORD, MA, and INDIANAPOLIS, IN – December 18, 2023 – Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT Biopharma Global Inc. (POINT) (NASDAQ: PNT) today announced statistically significant topline results from the pivotal Phase 3 SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI).

“There is an urgent unmet need for targeted treatment options for mCRPC patients, particularly for those whose cancer has progressed on androgen receptor pathway inhibitors,” said Dr. Kim Chi, SPLASH Principal Investigator, Medical Oncologist, BC Cancer. “The SPLASH study results demonstrate that 177Lu-PNT2002 is well-tolerated and has the potential to play an important role in addressing those needs for patients with chemotherapy-naïve mCRPC.”

The SPLASH trial met its primary endpoint, demonstrating a median radiographic progression-free survival (rPFS) per blinded independent central review of 9.5 months for patients treated with 177Lu-PNT2002, compared to 6.0 months for patients treated with ARPI in the control arm, a statistically significant 29% reduction in the risk of radiographic progression or death (hazard ratio [HR] 0.71; p=0.0088). At the time of the analysis, interim overall survival (OS) results were immature (46% of protocol-specified target OS events reached), the HR was 1.11. The companies expect additional, follow-up data in 2024 prior to the potential submission of a New Drug Application (NDA).

177Lu-PNT2002 demonstrated a favorable safety profile with grade ≥3 treatment-emergent adverse events (TEAEs) per Common Terminology Criteria for Adverse Events (CTCAE), serious TEAEs, and TEAEs leading to discontinuation occurring at lower rates in the 177Lu-PNT2002 arm than in the ARPI arm (30.1%, 17.1%, and 1.9% vs. 36.9%, 23.1%, and 6.2%, respectively).

 

     177Lu-PNT2002 Arm     ARPI Arm  

TEAEs of CTCAE Grade ≥3

     30.1     36.9

Serious TEAEs

     17.1     23.1

TEAEs Leading to Discontinuation

     1.9     6.2

The open-label study randomized 412 patients with PSMA-expressing mCRPC who had progressed on ARPI therapy and either refused or were not eligible for chemotherapy, in a 2:1 randomization ratio (177Lu-PNT2002: control group). At the time of the analysis, 84.6% of patients who experienced progressive disease in the control arm subsequently crossed over to receive 177Lu-PNT2002. SPLASH was conducted across the United States, Canada, Europe, and the United Kingdom. Eighty percent of SPLASH patients resided in North America and approximately 10% of all participants were Black or African American.


“The success of 177Lu-PNT2002 in this trial demonstrates the value of treating patients with radioligand therapy at this stage of the disease continuum. With only four treatment administrations over a 32-week period, this regimen provides reduced treatment intensity compared to the control arm, while also delaying disease progression with lower toxicity,” said Neil Fleshner, M.D., Co-founder and Chief Medical Officer at POINT Biopharma. “We extend our deepest gratitude to the SPLASH study participants and their families and caregivers, as well as the investigators and their hard-working staff.”

“We are encouraged by the results of the SPLASH trial, which showed the benefits that 177Lu-PNT2002 offers to patients with mCRPC. We are proud to be at the forefront of advancing the potential of targeted RLT with 177Lu-PNT2002. As the leading radiopharmaceutical-focused company, we are committed to providing clinicians with cutting-edge options to fight disease and improve patient outcomes,” said Jean-Claude Provost, M.D., Chief Medical Officer at Lantheus. “We look forward to sharing additional data in the future, and to collaborating with regulatory authorities and POINT Biopharma to bring this promising therapy to the prostate cancer patient community.”

Full SPLASH trial results will be presented at a future medical congress.

About the SPLASH Trial

The phase 3 SPLASH trial is a multicenter, randomized, open label assessment of 177Lu-PNT2002 in patients with PSMA-expressing mCRPC who have progressed on ARPI therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study randomized 412 patients across North America, Europe, and the United Kingdom. Patients were randomized 2:1 with those in arm A receiving 177Lu-PNT2002 and those in arm B receiving either abiraterone or enzalutamide. Patients in arm B who experience centrally assessed radiographic progression and meet protocol eligibility have the option to crossover and receive 177Lu-PNT2002. Patients will be followed for up to 5 years from their first 177Lu-PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. More information about the trial is accessible at www.ClinicalTrials.gov, identifier NCT04647526.

About 177Lu-PNT2002

177Lu-PNT2002 is a PSMA-targeted, lutetium 177-based radioligand therapy candidate that combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added lutetium-177. Lantheus Holdings, Inc. in-licensed exclusive worldwide commercialization rights (excluding certain Asian territories) to 177Lu-PNT2002 from POINT in December of 2022. In April of 2023, the FDA granted Fast Track designation for 177Lu-PNT2002 for the treatment of mCRPC. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States — an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2023, almost 288,300 new cases of prostate cancer will be diagnosed, and about 34,700 men will die of the disease.1


About Lantheus

Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for more than 65 years. For more information, visit www.lantheus.com.

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 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. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com/.

Safe Harbor for Forward-Looking and Cautionary Statements

This press release contains “forward-looking statements” that are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements relating to the potential of PNT2002 and statements regarding Lantheus’ and POINT’S expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements may be identified by their use of terms such as “expected,” “look,” “planned,” “potential,” “will,” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the outcome of the SPLASH trial after full data is available; (ii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and regulatory authorities for PNT2002; (iii) the additional costs and risks associated with Lantheus’ ability to successfully launch PNT2002 as a commercial product; (iv) the market and patient receptivity to PNT2002 as a radiopharmaceutical therapy; (v) the existence, availability and profile of competing products and therapies; (vi) Lantheus’ ability to obtain and maintain adequate coding, coverage and payment for PNT2002; (vii) the intellectual property protection of PNT2002; (viii) POINT’s ability to successfully develop and scale the manufacturing capabilities to support the launch of PNT2002; and (ix) the risks and uncertainties discussed in Lantheus’ and POINT’s filings with the Securities and Exchange Commission (including those described in the Risk Factors section in their Annual Reports on Form 10-K and their Quarterly Reports on Form 10-Q).The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. Neither Lantheus nor POINT undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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.

 

1.

American Cancer Society. Facts & Figures 2023. American Cancer Society. Atlanta, GA. 2023

Contacts:

Lantheus

Mark Kinarney

Vice President, Investor Relations

978-671-8842

ir@lantheus.com

Melissa Downs

Senior Director, External Communications

646-975-2533

media@lantheus.com

POINT Biopharma

Daniel Pearlstein

Director, Strategy

investors@pointbiopharma.com


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