Form 8-K

0001171843-22-003483.txt : 20220510 0001171843-22-003483.hdr.sgml : 20220510 20220510080049 ACCESSION NUMBER: 0001171843-22-003483 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220510 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220510 DATE AS OF CHANGE: 20220510 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AGENUS INC CENTRAL INDEX KEY: 0001098972 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 061562417 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29089 FILM NUMBER: 22907439 BUSINESS ADDRESS: STREET 1: 3 FORBES ROAD CITY: LEXINGTON STATE: MA ZIP: 02421 BUSINESS PHONE: 781-674-4410 MAIL ADDRESS: STREET 1: 3 FORBES ROAD CITY: LEXINGTON STATE: MA ZIP: 02421 FORMER COMPANY: FORMER CONFORMED NAME: ANTIGENICS INC /DE/ DATE OF NAME CHANGE: 19991115 8-K 1 f8k_051022.htm FORM 8-K Form 8-K

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

May 10, 2022
Date of Report (Date of earliest event reported)

_______________________________

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) (Zip Code)

(781) 674-4400

(Registrant's telephone number, including area code)

(Former name or former address, if changed since last report)

_______________________________

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 pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.01 par value per share	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 2.02. Results of Operations and Financial Condition.

On May 10, 2022, Agenus Inc. announced its financial results for the quarter ended March 31, 2022. In connection with the announcement, the Company issued a press release, which is being furnished as Exhibit 99.1 to this current report on Form 8-K.

The information set forth under Item 2.02 and in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibit

The following exhibit is furnished herewith:

99.1 Press Release dated May 10, 2022
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

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.

	AGENUS INC.


Date: May 10, 2022	By:	/s/ Christine M. Klaskin
		Christine M. Klaskin
		VP, Finance

EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFiling

EXHIBIT 99.1

Agenus Corporate Update and First Quarter 2022 Financial Report

Botensilimab data to be presented and Phase 2 trials to launch.
AGEN1571 (ILT2) clinical trials to commence and data presented at AACR.
AGEN2373 progressing in the clinic and Gilead milestone payment received.

LEXINGTON, Mass., May 10, 2022 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, today provided a corporate update and reported financial results for the first quarter 2022.

“In the current challenging environment for the biotech industry, we are prioritizing our most promising clinical programs, including botensilimab combinations, as well as preclinical programs with the highest potential for engagement from collaborators,” said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. “Needless to say, we are also taking decisive steps to contain costs across the board despite our reasonable cash position.”

Botensilimab, Agenus’ innate and adaptive immune stimulator, to advance to Phase 2

Present updated data from our ongoing development program in the 3^rd quarter.
Phase 2 clinical studies to commence in colorectal, melanoma, and pancreatic cancers.
All trials designed to demonstrate superiority to other immunotherapies and/or other standards of care.
In addition, trials are designed to show benefit in cold tumors in combination with chemotherapy.

AGEN1571 clinical trials to commence; preclinical data presented at AACR

Agenus’ first myeloid-targeting agent.
Overcomes the suppression of anti-tumor response via the ILT2 pathway which drives resistance to CTLA-4 and PD-1 directed therapies.
Rationale is further validated by the durable clinical responses achieved in PD-1 resistant cancers with an ILT4 antagonist discovered by Agenus and licensed to Merck.
Provides advantages in enhanced activation of T, NK and NKT cells and a superior ability to switch myeloid cells to a pro-inflammatory state.
Phase 1 study to commence.

Milestone payment received from Gilead for the clinical advancement of AGEN2373 targeting CD137

Another key pathway for antitumor immunity with enhancement of T cell and NK cell proliferation, cytokine secretion, and cellular cytotoxicity.
Phase 1b combination study with botensilimab ongoing in melanoma patients who have relapsed or are refractory to prior anti-PD-1 therapy.
Gilead has an exclusive option to license AGEN2373, while Agenus can opt-in for a 50:50 profit share and US co-commercialization rights.
Agenus received $5M milestone payment with up to $570 million in future potential option fees and milestones.

First Quarter 2022 Financial Results

We ended our first quarter 2022 with a cash and short-term investment balance of $263 million as compared to $307 million on December 31, 2021.

We recognized revenue of $26 million for the quarter ended March 31, 2022, which represents an increase of $14 million from the $12 million reported for the same quarter in 2021. Both numbers include revenue related to non-cash royalties earned, revenue recognized under our collaboration agreements, and in 2022, milestones received.

Net loss for the quarter ended March 31, 2022, was $51 million which includes non-cash expenses of $21 million compared to a net loss for the same period of 2021 of $54 million which includes non-cash expenses of $20 million. Per share losses were $0.19 in the first quarter of 2022 as compared to per share losses of $0.27 in the first quarter of 2021.

Cash used in operations for the three months ended March 31, 2022, was $52 million up from $43 million for the quarter ended March 31, 2021. The company has initiated cost containment measures with expected reductions in operating expenses in coming quarters.



Select Financial Information
(in thousands, except per share data)
(unaudited)

	March 31, 2022			December 31, 2021

Cash, cash equivalents and short-term investments	$	262,687		$	306,923


	Three months ended March 31,
	2022			2021

Revenues, research and development	$	6,740		$	1,571
Revenues, non-cash royalty	17,634			8,484
Revenues, other	1,567			1,664
Total Revenue	25,941			11,719


Research and development expenses	42,442			36,677
General and administrative expenses	18,953			16,352
Cost of service revenue	543			1,105
Other (income) expense	191			(2,579		)
Non-cash interest expense	14,952			15,611
Non-cash contingent consideration fair value adjustment	(536		)	(1,044		)
Net loss	$	(50,604	)	$	(54,403	)

Net loss per share attributable to Agenus Inc. common stockholders:	$	(0.19	)	$	(0.27	)

Cash used in operations	$	52,391		$	42,744
Non-cash operating expenses	$	21,069		$	20,297

Conference Call
Tuesday, May 10, 2022, 8:30am ET
Dial-in numbers: (866) 374-5140 (US Toll-Free) or (404) 400-0571 (US Toll)
Conference PIN: 71044045#

Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at https://investor.agenusbio.com/events-and-presentations and via https://edge.media-server.com/mmc/p/5nove2tf.

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 and infections. 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 subsidiary MiNK Therapeutics), adjuvants, 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. Information that may be important to investors will be routinely posted on our website and Twitter.

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 relating to the use of therapeutic candidates botensilimab, AGEN1571, and AGEN2373, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action (including validation of mechanism of action), potency, durability, and safety profile of the therapeutic candidates, both alone and in combination with each other and/or other agents (e.g., botensilimab in combination with balstilimab); statements relating to future clinical and regulatory development plans for therapeutic candidates alone and in combination with other agents, including botensilimab in combination with balstilimab; statements relating to superiority of our therapeutic candidates over third party therapeutics and therapeutic candidates; statements relating to current or future manufacturing capabilities, manufacturing sustainability and cost-effective manufacturing; statements relating to planned savings or efficiencies; and any other statements containing the words "may," "expects," "anticipates," "will," “establish,” “potential,” “superiority,” and similar expressions are intended to identify forward-looking statements. 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

Ethan Lovell
339-927-1763
ethan.lovell@agenusbio.com

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