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): June 20, 2020

 

 

AGENUS INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-29089   06-1562417

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

3 Forbes Road

Lexington, MA 02421

(Address of principal executive offices, including zip code)

(781) 674-4400

(Registrant’s telephone number, including area code)

 

 

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 or to be 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 $0.01   AGEN   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 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

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 1.01 Entry into a Material Definitive Agreement.

License Agreement

On June 20, 2020, Agenus Inc. (“Agenus”) entered into a License and Collaboration Agreement (“License Agreement”) with Betta Pharmaceuticals Co., Ltd. (“Betta Pharma”) to collaborate on the development and commercialization of Agenus’s anti-PD-1 antibody, balstilimab, and Agenus’s anti-CTLA-4 antibody, zalifrelimab, in the People’s Republic of China, Hong Kong, Macau and Taiwan (the “Territory”).

Pursuant to the terms of the License Agreement, Agenus grants Betta Pharma an exclusive license under certain of Agenus’s intellectual property rights to develop, manufacture and commercialize zalifrelimab and balstilimab in all fields (other than intravesical delivery) in the Territory. Betta Pharma is responsible for all of the development, regulatory approval, manufacturing and commercialization costs in the Territory. As part of the collaboration, Betta Pharma has agreed to make an upfront cash payment of $15.0 million and up to $100.0 million in aggregate milestone payments plus tiered royalties on net sales of zalifrelimab and balstilimab in the Territory. Royalties range from mid-single digit to low-twenties percent, subject to certain reductions under certain circumstances as described in the License Agreement. The royalty term shall terminate on a product-by-product and country-by-country basis on the latest of (i) the ten (10) year anniversary of the first commercial sale of such product in such country, (ii) the expiration of any regulatory exclusivity period that covers such product in such country, and (iii) the expiration of the last-to-expire licensed patent that covers such product in such country. In addition, Betta Pharma has agreed to purchase Agenus stock valued at $20.0 million as described below.

The License Agreement includes customary representations and warranties, covenants and indemnification obligations for a transaction of this nature. The License Agreement became effective upon signing and will continue until all of Betta Pharma’s applicable payment obligations under the License Agreement have been performed or have expired, or the agreement is earlier terminated. Under the terms of the License Agreement, Agenus and Betta Pharma each have the right to terminate the agreement for material breach by, or insolvency of, the other party. Betta Pharma may also terminate the License Agreement in its entirety, or on a product-by-product or country-by-country basis, for convenience upon ninety (90) days’ notice.

Stock Purchase Agreement

One June 20, 2020 and in connection with the execution of the License Agreement, Agenus, Betta Pharma and Betta Investment (Hong Kong) Limited, a wholly-owned subsidiary of Betta Pharma (“Betta HK”), entered into a Stock Purchase Agreement (the “Stock Purchase Agreement” and together with the License Agreement, the “Betta Agreements”), pursuant to which Betta HK agreed to purchase 4,962,779 shares of Agenus common stock (the “Shares”) for an aggregate purchase price of approximately $20.0 million, or $4.03 per share, which represents a 10% premium over the 7-day volume weighted average closing price prior to signing. Betta HK will own approximately 2.8% of the outstanding shares of Agenus common stock after such purchase. Under the Stock Purchase Agreement, Betta HK has agreed not to dispose of any of the Shares for a period of 12 months and to vote the Shares in accordance with the recommendations of the Agenus board of directors for a period of 12 months. Agenus has agreed to register the Shares for resale under the Securities Act of 1933, as amended (the “Securities Act”). Closing under the Stock Purchase Agreement is subject to customary closing conditions, as well as continued effectiveness of the License Agreement and Betta HK’s receipt of a certificate of outbound investment by enterprises by the Ministry of Commerce of the People’s Republic of China, the National Development and Reform Commission of the People’s Republic of China and State Administration of Foreign Exchange of the People’s Republic of China or their local counterparts. The Stock Purchase Agreement also includes customary representations and warranties, covenants and indemnification obligations.

The foregoing descriptions of the Betta Agreements do not purport to be complete and are qualified in their entirety by reference to the text of the Betta Agreements, which will be filed as exhibits to Agenus’ Quarterly Report on Form 10-Q for the quarter ending June 30, 2020.

On June 22, 2020, Agenus issued a press release relating to the Betta Agreements. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 3.02 Unregistered Sales of Equity Securities.

The information provided above under Item 1.01 of this Current Report on Form 8-K is hereby incorporated by reference into this Item 3.02. The Shares are to be sold to Betta HK in reliance upon an exemption from registration afforded by Section 4(2) of the Securities Act as the transaction does not involve any public offering. Betta HK has represented to Agenus that it is an “accredited investor” within the meaning of Regulation D.

Item 9.01. Financial Statements and Exhibits.

 

(d)

Exhibits

 

Exhibit No.    Description
99.1    Press release issued by Agenus Inc. dated June 22, 2020

SIGNATURES

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.

 

Date: June 22, 2020

    AGENUS INC.
   

By:

 

/s/ Evan D. Kearns

     

Evan D. Kearns

     

VP, General Counsel and Secretary

Exhibit 99.1

Agenus and Betta Pharmaceuticals Enter Into a License Agreement for Balstilimab and Zalifrelimab in Greater China

 

  •  

Agenus to receive $35M upfront with $100M in milestones plus royalties

 

  •  

Betta receives exclusive license of balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) in Greater China

LEXINGTON, Mass., June 22, 2020 /PRNewswire/ — Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with an extensive pipeline of agents designed to activate immune response to cancers, announced today that it has entered into an agreement with Betta Pharmaceuticals (SZ300558), a top Chinese pharmaceutical company focusing on the development of innovative oncology therapies, for an exclusive collaboration and license agreement for the development and commercialization of balstilimab and zalifrelimab in Greater China, including Mainland China, Hong Kong, Macau and Taiwan.

Under the terms of the agreement, Agenus will receive $35 million, which includes a $15 million in upfront cash and a $20 million equity investment. The agreement also includes $100 million in potential milestones plus royalties on net sales. Betta receives exclusive rights for the development and commercialization of balstilimab and zalifrelimab to either as monotherapies or combination therapies, excluding intravesical delivery in greater China.

Agenus’ balstilimab (anti-PD-1) is advancing in trials planned for BLA filing this year as a monotherapy and in combination with zalifrelimab (anti-CTLA-4) for the treatment of refractory or metastatic cervical cancer. Agenus has recently reported positive results suggesting robust and durable responses of balstilimab and zalifrelimab in patients with relapsed or refractory metastatic cervical cancer. The US FDA recently granted Fast Track designation for balstilimab alone and in combination with zalifrelimab in this indication.

“Betta has a strong track record of advancing innovative products in China and a growing portfolio of complementary oncology therapies,” said Garo Armen, Chairman and Chief Executive Officer of Agenus. “Betta is an ideal partner to enable us to address significant patient needs in China while also advancing global development of balstilimab and zalifrelimab.”

“We are delighted to enter this collaboration with Agenus, a leader in the immuno-oncology field, as the first step in a long-term strategic partnership,” said Lieming Ding, Chairman and Chief Executive Officer of Betta Pharmaceuticals. “ Based on the compelling clinical data reported to date, we believe Agenus’ balstilimab and zalifrelimab hold great promise for Chinese patients with cervical cancer, with the potential to further expand in additional tumor types through synergistic combinations with Betta’s existing pipeline programs.”

The equity purchase component of the transaction is subject to China regulatory approval and other customary closing conditions.

About Agenus

Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer. The Company’s vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio.

About Betta Pharmaceuticals

Betta Pharmaceuticals Co., Ltd. (SZ300558), established in 2003 in Hangzhou, China, is one of the leading Chinese pharmaceutical companies dedicated to develop and commercialize innovative oncology products to meet high unmet medical needs. With over 1,300 employees in Hangzhou and Beijing, Betta’s development capabilities range from small-molecule to biologics discovery, clinical development, manufacturing, sales and marketing. Betta’s leading product – icotinib (Conmana®), the first innovative oncology product developed and launched in China – is one of the top selling targeted therapies for patients with non-small cell lung cancer, having achieved 1.55 billion RMB annual sales in 2019. Betta currently has two programs under NDA review by the NMPA, two programs under late-stage clinical development, eight programs under proof-of-concept clinical development, and multiple small-molecule and biologics programs under pre-clinical discovery. Throughout the years, Betta has set up strategic partnerships with Amgen Inc., Xcovery LLC., Beijing Mabworks Biotech Co., Ltd., Tyrogenex Inc., InventisBio lnc., and Merus N.V.. For additional information, please visit http://bettapharma.com/en.php

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the anticipated closing and expected benefits of the collaboration, as well as timing for planned BLA filings. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not

to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Contact:

Agenus Inc.

Jennifer S. Buell, PhD

781-674-4420

Jennifer.Buell@agenusbio.com