Filing Details

CUSIP No.  73730P108

SCHEDULE 13D

1	NAMES OF REPORTING PERSONS
		Astellas US Holding, Inc.
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP					(a)  ☐
						(b)  ☒
3	SEC USE ONLY
4	SOURCE OF FUNDS (See Instructions)
		WC
5	CHECK IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) OR 2(e)					☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
		Delaware
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH			7	SOLE VOTING POWER
					-0-
			8	SHARED VOTING POWER
					8,333,333(1)
			9	SOLE DISPOSITIVE POWER
					-0-
			10	SHARED DISPOSITIVE POWER
					8,333,333(1)
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
		8,333,333(1)
12	CHECK IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (See Instructions)					☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
		8.7%(2)
14	TYPE OF REPORTING PERSON (See Instructions)
		CO

1

Represents shares of the Issuer’s common stock directly held by Astellas US LLC, a wholly owned direct subsidiary of Astellas US Holding, Inc., which is in turn a wholly owned direct subsidiary of Astellas Pharma Inc. Astellas Pharma Inc., Astellas US Holding, Inc. and Astellas US LLC may each be deemed to have shared voting and dispositive power over all of the shares.

This Statement is being filed on behalf of each of the following persons (each a “Reporting Person” and, collectively, the “Reporting Persons”):

(iii)

Astellas US LLC, a company formed under the laws of Delaware (“Astellas US”), with its principal business address at 2375 Waterview Drive, Northbrook, IL 60062.

 

The Reporting Persons are part of a pharmaceutical business operating in more than 70 countries around the world. The business is promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality.

 

The directors and executive officers of each Reporting Person are set forth on Schedule I, attached hereto. Schedule I sets forth the following information with respect to each such person:

 

(a) name;

 

(b) business address;

 

(c) position with the Reporting Person and present principal occupation or employment and, for persons not employed by the Reporting Persons, the name, principal business and address of any corporation or other organization in which such employment is conducted; and

 

(f) citizenship.

 

(d) - (e) During the last five years, neither the Reporting Persons nor, to the knowledge of the Reporting Persons, any person named in Schedule I have been (i) convicted in a criminal proceeding (excluding traffic violations or similar misdemeanors) or (ii) a party to a civil proceeding of a judicial or administrative body of competent jurisdiction, as a result of which, he, she or it was or is subject to a judgment, decree or final order enjoining future violations of, or prohibiting or mandating activities subject to, federal or state securities laws or finding any violation with respect to such laws.

This information set forth in Item 6 of this Statement is incorporated by reference in its entirety into this Item 3. Capitalized terms used but not defined in this Item 3 or the preceding Items of this Statement are defined in Item 6.

 

On August 4, 2023, the Issuer and Astellas US entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”), pursuant to which, among other things, the Issuer agreed to issue and sell to Astellas US in a private placement an aggregate of 8,333,333 shares of common stock of the Issuer, for an aggregate purchase price of approximately $25.0 million. On August 7, 2023, Astellas US paid such purchase price to the Issuer and the Issuer delivered to Astellas US such shares of the Issuer’s common stock and the transaction contemplated by the Securities Purchase Agreement closed.

 

Also on August 4, 2023, the Issuer and Astellas US entered into a Strategic Rights Letter Agreement, attached hereto as Exhibit 5 (the “Strategic Rights Letter”). Pursuant to the Strategic Rights Letter, as partial consideration for the rights afforded to Astellas US thereunder, Astellas US agreed to pay the Issuer a one-time payment in the amount of $25.0 million (the “Upfront Payment”). In connection with a Change in Control transaction (as defined in the Strategic Rights Letter) or Program Transaction between the Issuer and Astellas, some, all or none of the Upfront Payment may be offset against payments owed by Astellas to the Company or its controlled affiliates, dependent on certain factors set forth in the Strategic Rights Letter. A “Program Transaction” is an exclusive or co-exclusive license or co-promote or co-marketing arrangement or granting of commercial rights to sell, promote or market one or more products of the Program for any indication in the world.

 

The shares of the Issuer purchased by the Reporting Persons were purchased using general working capital and cash on hand.

 

On August 4, 2023, the Issuer and Astellas US entered into a registration rights agreement, attached hereto as Exhibit 4 (the “Registration Rights Agreement”), pursuant to which the Issuer agreed to register the resale of the Shares. Under the Registration Rights Agreement, the Issuer has agreed to file a registration statement covering the resale of the Shares no later than April 13, 2024. The Issuer has agreed to use reasonable best efforts to cause such registration statement to become effective as promptly as practicable after the filing thereof but in any event on or prior to the Effectiveness Deadline (as defined in the Registration Rights Agreement), and to keep such registration statement continuously effective until the earlier of (i) the date the Shares covered by such registration statement have been sold or may be resold pursuant to Rule 144 without restriction, or (ii) the date that is three (3) years following the Closing Date. The Issuer has also agreed, among other things, to pay all reasonable fees and expenses (excluding any underwriters’ discounts and commissions and all fees and expenses of legal counsel, accountants and other advisors for Astellas US except as specifically provided in the Registration Rights Agreement) incident to the performance of or compliance with the Registration Rights Agreement by the Issuer.

 

The Issuer and Astellas US granted each other customary indemnification rights in connection with the registration statement. The Issuer made additional customary covenants, including with respect to “piggyback” registrations, cooperating in underwritten offerings of the Shares and taking steps to allow the Shares to be resold pursuant to Rule 144 under the Securities Act of 1933.

 

The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference to such agreement, a copy of which is attached hereto as Exhibit 4 and incorporated into this Item 6 by reference.

 

 

On August 4, 2023, the Issuer and Astellas US entered into the Strategic Rights Letter. Pursuant to the Strategic Rights Letter, the Issuer granted Astellas US the right to designate a representative, reasonably acceptable to the Issuer, to attend meetings and receive related materials provided thereto of the Issuer’s board of directors (the “Board”), any committee of the Board, and the Issuer’s scientific advisory board, subject to certain customary exceptions. The rights described in this sub-section are referred to in this Statement as the “Board Observer Rights.”

 

During the period beginning on the Closing Date and ending on the 12-month anniversary of the Closing Date (the “Exclusivity Period”), the Issuer has agreed not to (i) solicit, knowingly encourage, negotiate or otherwise enter into bona fide discussions about a Program Transaction with any third party, (ii) provide access to any confidential information of the Issuer relating to P-MUC1C-ALLO1, the Issuer’s fully allogeneic CAR-T product candidate for multiple solid tumor indications (the “Program”), for purposes of knowingly facilitating a Program Transaction, or (iii) enter into any letter of intent, contract or other commitment for a Program Transaction. The rights described in this sub-section are referred to in this Statement as the “Exclusivity Rights.”

 

Further, pursuant to the Strategic Rights Letter, the Issuer has agreed to provide notice to Astellas US (i) if the Issuer receives a bona fide proposal for a Change in Control (as defined in the Strategic Rights Letter) transaction from a third party, unless such proposal is rejected by the Board, or (ii) of the commencement of a process approved by the Board for a Change in Control, (iii) if the Issuer receives a bona fide proposal for a Program Transaction from a third party unless the proposal is rejected by the Board (a “Program Transaction Proposal”) or, (iv) following the Exclusivity Period, the commencement of substantive discussions for a Program Transaction with a third party in connection with a process approved by the Board for a Program Transaction (a “Program Process”). In connection with a notice related to (x) a Program Transaction Proposal, Astellas shall have a right of first refusal to provide a competing proposal that is in aggregate more favorable to the Issuer than the Program Transaction Proposal, and thereby have a right to negotiate exclusively a possible Program Transaction for a specified period and (y) a Program Process, Astellas US shall have a right of first offer to negotiate a Program Transaction for a specified period before the Issuer engages with any third party in meaningful substantive discussions, in each case, in accordance with the procedures and subject to the conditions set forth in the Strategic Rights Letter. The rights described in this sub-section are referred to in this Statement as the “Strategic Transaction Rights.”

 

This Strategic Rights Letter shall terminate upon the earliest to occur of (i) the 18-month anniversary of the Closing Date, (ii) such time that Astellas US owns fewer than 8,000,000 shares of the Issuer’s common stock (subject to adjustment for any stock splits, stock dividends or recapitalizations) and (iii) the consummation of a Change in Control.

 

The foregoing description of the Strategic Rights Letter does not purport to be complete and is qualified in its entirety by reference to such agreement, a copy of which is attached hereto as Exhibit 5 and incorporated into this Item 6 by reference.

Schedule I

 

 

The name and present principal occupation of each of the executive officers and directors of Astellas Pharma Inc. are set forth below. Unless otherwise noted, each of these persons has as their business address 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, Japan.