Form 8-K - Current report

Date: August 8, 2024

Agenus Inc.

/s/ Christine M. Klaskin

Christine M. Klaskin

VP Finance

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): August 7, 2024

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 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 Global 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 August 8, 2024, Agenus Inc. (“Agenus”) announced its financial results for the quarter ended June 30, 2024. In connection with the announcement, Agenus 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 5.02

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On August 7, 2024, the Board of Directors (the “Board”) of Agenus elected Thomas L. Harrison to become a Class III director of Agenus with an initial term that expires at Agenus’s annual meeting of stockholders in 2027.

In connection with his election to the Board, Mr. Harrison was granted an option to purchase 7,500 shares of the Agenus’s common stock pursuant to Agenus’s 2019 Equity Incentive Plan and Agenus’s non-employee director compensation program. The option has a per-share exercise price equal to the closing price of Agenus’s common stock on the Nasdaq Capital Market on the date of grant and a 10-year term, and it vests over three years in equal annual installments (provided Mr. Harrison maintains a service relationship with Agenus through each such vesting date). As a non-employee director, Mr. Harrison will also receive cash and additional equity compensation paid by Agenus pursuant to its non-employee director compensation program. There are no arrangements or understandings between Mr. Harrison and any other person pursuant to which Mr. Harrison was selected as a director, and there are no transactions between Mr. Harrison and Agenus that would require disclosure under Item 404(a) of Regulation S-K.

On August 8, 2024, Agenus issued a press release announcing Mr. Harrison’s appointment to the Board. A copy of this press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

Item 8.01

Other Events.

On August 8, 2024, Agenus filed a prospectus supplement with the U.S. Securities and Exchange Commission in connection with the offer and sale of up to 13,843,015 shares (the “Placement Shares”) from time to time in “at the market” offerings pursuant to an At Market Issuance Sales Agreement with B. Riley Securities, Inc. (formerly B. Riley FBR Inc., the “Sales Agent”), dated as of July 22, 2020 (the “Agreement”). Sales pursuant to the Agreement will be made only upon instructions by Agenus to the Sales Agent, and Agenus cannot provide any assurances that it will issue any Placement Shares pursuant to the Agreement.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is incorporated herein by reference. A copy of the opinion of Ropes & Gray LLP relating to the legality of the issuance and sale of the Placement Shares is attached as Exhibit 5.1 hereto.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits


Exhibit No.		Description

1.1		Sales Agreement dated July 22, 2020 by and between Agenus Inc. and B. Riley FBR, Inc. Incorporated by reference to Exhibit 1.2 on Form S-3ASR filed by the Company on July 22, 2020

5.1		Opinion of Ropes & Gray LLP

23.1		Consent of Ropes & Gray LLP (included in Exhibit 5.1)

99.1		Press Release dated August 8, 2024

99.2		Press Release dated August 8, 2024

104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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.

Exhibit 5.1

LOGO

August 8, 2024

Agenus Inc.

3 Forbes Road

Lexington, MA 02421

Re: Registration of Securities by Agenus Inc.

Ladies and Gentlemen:

We have acted as counsel to Agenus Inc., a Delaware corporation (the “Company”) in connection with its filing of a Registration Statement on Form S-3 (Registration No. 333-272911) (the “Registration Statement”), filed with the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended (the “Securities Act”) and the related prospectus supplement dated August 8, 2024 (the “Prospectus Supplement”) relating to the sale of up to 13,843,015 shares (the “Shares”) of the common stock of the Company, $0.01 par value (“Common Stock”). The Shares will be sold pursuant to an At Market Issuance Sales Agreement, by and between the Company and B. Riley Securities, Inc. (the “Agreement”).

In connection with this opinion letter, we have examined such certificates, documents and records and have made such investigation of fact and such examination of law as we have deemed appropriate in order to enable us to render the opinions set forth herein. In conducting such investigation, we have relied, without independent verification, upon certificates of officers of the Company, public officials and other appropriate persons.

The opinion expressed below is limited to the Delaware General Corporation Law.

Based upon and subject to the foregoing, we are of the opinion that the Shares have been duly authorized and, when the Shares are issued out of the Company’s duly authorized Common Stock and sold in accordance with the terms of the Agreement, the Shares will be validly issued, fully paid and non-assessable.

We hereby consent to your filing this opinion as an exhibit to the Registration Statement and to the use of our name therein and in the Prospectus Supplement under the caption “Legal Matters.” In giving such consent, we do not thereby admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the Commission thereunder.

Very truly yours,

/s/ Ropes & Gray LLP

Ropes & Gray LLP

Exhibit 99.1

Agenus Reports Second Quarter 2024 Operational and Financial Results

•

Robust Phase 2 Data Validate Consistent Clinical Activity of BOT/BAL in Metastatic MSS CRC

•

Maturing Data Across BOT/BAL Program Demonstrate Broad Solid Tumor Activity in the Late Stage, First-Line with Chemo Combinations, and Neoadjuvant disease

•

Commenced Interactions with Global Regulatory Authorities for BOT/BAL Approval Pathways

•

Data from ESMO GI Demonstrate Pathologic Complete Responses with BOT/BAL Therapy in Neoadjuvant CRC Patients

LEXINGTON, Mass.—(BUSINESS WIRE) — Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today provided a corporate update and reported financial results for the second quarter of 2024.

“Agenus milestones this quarter include the release of interim data from our global randomized Phase 2 trial of BOT/BAL in relapsed/refractory MSS colorectal cancer, consistent with our Phase 1 results,” said Garo Armen, PhD, Chairman and CEO of Agenus. “The robust responses in this trial and across various solid tumors validate BOT/BAL’s potential to address challenging cancer cases. Our data show significant and durable tumor reductions in patients who have exhausted other treatments. We are continuing to work with global health authorities and are dedicated to ensuring swift access to these life-saving therapies. We are deeply moved by the strong support from the patient advocacy and clinical communities and remain committed to accelerating the BOT/BAL program and delivering innovative therapies to patients.”

Key Highlights:

•

Maturing Data Demonstrate Activity in Multiple Cancers and Stages of Disease: Data from our BOT/BAL clinical program in ~1,100 patients have demonstrated robust activity across 10 different cancers and across early and late-stage disease, including refractory metastatic and neoadjuvant settings. This includes durable tumor reductions and, in some cases, complete responses in patients who have failed approved therapies. Some of these data have already been presented and published, with new data to be presented at upcoming conferences and published in top tier scientific publications.

•

Promising Interim Data: Topline interim data from the randomized Phase 2 trial in r/r MSS CRC show trends consistent with the more mature data from the Phase 1 study at a similar follow up timepoint. This includes a now RECIST confirmed overall response rate (ORR) of 19.4% and a 6-month overall survival (OS) rate of 90% in the selected BOT 75mg/BAL combination cohort. BOT/BAL’s safety profile continues to be manageable, with no new signals observed.

•

Nature Medicine and Cancer Discovery Publications: Recent publications in Nature Medicine and Cancer Discovery highlighted the promising results of the BOT/BAL combination in metastatic MSS CRC, the most prevalent form of CRC, affecting 95% of metastatic CRC patients.

•

NEST Study Results: Updated results from the NEST study in neoadjuvant CRC presented at ESMO GI in June demonstrated unprecedented activity of BOT/BAL in MSS CRC that has historically been poorly responsive to IO therapies. In the NEST-2 cohort of extended treatment (8 weeks), 78% (7/9) of MSS CRC patients achieved pathologic responses of at least 50% tumor reduction, with 56% (5/9) achieving complete pathologic responses (cPR). Toxicities were well managed, and no surgeries were delayed due to adverse events.

•

ASCO Annual Meeting: New analyses presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June highlighted BOT/BAL activity in metastatic CRC across challenging sites of metastatic disease, including peritoneal metastases, soft tissue, bone, and brain. The ORR was consistent across favorable and unfavorable sites of disease and ranged from 18-33%, with disease control rates (DCR) ranging from 67-82%. Median OS remained consistent and ranged from 20.7 months to not reached.

•

National Cancer Institute Collaboration: The National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP) began accepting Letters of Intent to conduct clinical studies using BOT during Q2. CTEP is also considering requests to supply BOT for nonclinical studies.

•

Global Regulatory Engagements: Agenus initiated engagement with the European Medicines Authority (EMA) and has subsequent meetings planned for this fall. In addition, Agenus will explore registration paths for BOT/BAL in r/r MSS CRC with regulatory authorities in other geographies, including the UK, Canada, Australia, Israel, and Brazil.

•

Upcoming Data: Agenus anticipates releasing further data later this year across the BOT/BAL program beyond MSS CRC that will continue to demonstrate the uniquely differentiated clinical activity of this combination therapy.

•

Phase 3 Study in r/r MSS CRC: Agenus has gained alignment with the FDA on the proposed design and dosing regimen for its upcoming Phase 3 study in the r/r MSS CRC treatment setting and intends to initiate this study soon.

•

FDA Interaction: While the FDA discouraged the submission of interim results for Accelerated Approval based on the dataset shared with them during the July End-of-Phase 2 meeting, Agenus plans to further engage the FDA with more mature data to support its AA strategy.

Partnerships and Financing

Agenus closed the first tranche of its $75 million royalty financing led by Ligand Pharmaceuticals, as announced in May. The company is continuing its efforts for a second closing of this financing. Additionally, Agenus is pursuing potential out-licensing transactions for several of its pipeline assets. This includes assets such as AGEN1777, previously licensed to Bristol Myers Squibb (BMS), and AGEN2373, for which Gilead’s (GILD) option period has expired. Agenus’ clinical and R&D teams are currently assessing the rich datasets generated in these programs.

“To support our efforts to deliver BOT/BAL to individuals living with colorectal cancer and other solid tumors, our strategic focus includes securing a global partnership for BOT/BAL. We are in discussions with several major biopharma companies that share our belief in the therapeutic regimen’s potential to provide meaningful clinical benefit to patients. The recent FDA interactions have provided additional clarity on the selection of dose and design of our phase 3 trial, which have been helpful in our partnership discussions,” said Robin Taylor, Agenus’ Chief Commercial Officer.

Agenus has also received recent interest in partnerships for its wholly owned Chemistry, Manufacturing, and Controls (CMC) infrastructure in Northern California, including the newly launched 83,000 sq. ft. cGMP facility in Emeryville, California.

As part of its commitment to patient care, Agenus is launching a Named Patient Program for BOT/BAL. This program will provide a framework for physicians to prescribe this investigational combination to eligible patients before it becomes commercially available. The program aims to offer early access to botensilimab for patients with critical needs, particularly those with colorectal cancer and other solid tumors that have not responded to standard treatments.

“Patients can’t wait, which is why Agenus is putting this Named Patient Program in place, a program that reflects our dedication to patients who need promising new therapies,” said Dr. Nils Eckardt, Global Head of Medical Affairs at Agenus. “By providing this early access pathway, we’re offering hope to patients with limited options while we continue to advance BOT/BAL through clinical development. This program underscores our commitment to patients and our confidence in BOT/BAL’s potential to transform cancer treatment.”

Second Quarter 2024 Financial Overview

We ended the second quarter 2024 with a consolidated cash balance of $93.7 million compared to $76.1 million on December 31, 2023.

For the three and six months ended June 30, 2024, we recognized revenue, which includes non-cash revenue, of $23.5 million and $51.5 million respectively. This compares to $25.3 million and $48.2 million, for the same periods in 2023. Our cash used in operations for the first half of 2024 was $76.4 million, reduced from $118.6 million for the first half of 2023. Our net loss for the three and six months ended June 30, 2024, is $54.8 million and $118.3 million; these include non-cash operating expenses of $33.5 million and $71.8 million, respectively.

Financial Highlights

(in thousands, except per share data)

(unaudited)


	June 30, 2024			December 31, 2023
Cash, cash equivalents and short-term investments	$	93,723		$	76,110

	Three months ended June 30,						Six months ended June 30,
	2024			2023			2024			2023
Revenues, non-cash royalty	$	22,582		$	22,068		$	50,349		$	41,174
Revenues, research and development		267			2,489			267			5,101
Revenues, other		660			739			898			1,923

Total Revenue		23,509			25,296			51,514			48,198
Research and development expenses		36,771			59,285			80,696			116,402
General and administrative expenses		16,816			20,415			33,672			38,653
Cost of service revenue		115			254			222			2,548
Other income		(7,064	)		(883	)		(6,088	)		(1,604	)
Non-cash interest expense		31,668			19,647			61,263			36,920
Non-cash contingent consideration fair value adjustment		—			8			—			(398	)

Net loss	$	(54,797	)	$	(73,430	)	$	(118,251	)	$	(144,323	)
Net loss per share attributable to Agenus Inc. common stockholders:	$	(2.52	)	$	(3.93	)	$	(5.56	)	$	(8.22	)
Cash used in operations	$	38,180		$	43,453		$	76,371		$	118,569
Non-cash operating expenses	$	33,520		$	28,947		$	71,775		$	53,882

Conference Call

Date: August 8th, 2024, 8:30 a.m. ET

To access dial-in numbers, please register here.

Conference ID: 73242

Webcast

A live webcast and replay of the conference call will be accessible on the company’s website at https://investor.agenusbio.com/events-and-presentations.

About Botensilimab

Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.

About Agenus

Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.

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 its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “forecasts,” “estimates,” “will,” “establish,” “potential,” “superiority,” “best in class,” 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 Annual Report on Form 10-K for 2023, and subsequent Quarterly Reports on Form 10-Q 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.

Investors

917-362-1370

investor@agenusbio.com

Media

612-839-6748

communications@agenusbio.com

Exhibit 99.2

Agenus Announces Appointment of Tom Harrison to Board of Directors

Advertising Veteran Tapped to Elevate Awareness of Agenus and Its Innovative Pipeline

Lexington, MA – Agenus Inc. (NASDAQ: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced the appointment of Tom Harrison to its Board of Directors. Mr. Harrison brings a wealth of experience and a proven track record in healthcare advertising, branding, and strategic advising.

Tom Harrison’s Background Highlights:

•

Chairman Emeritus of Diversified Agency Services (DAS), Omnicom Group Inc.: Harrison led the world’s largest group of marketing services companies, overseeing an unparalleled range of services including public relations, crisis management, branding, and healthcare advertising. Under his leadership, DAS grew to become the largest division within Omnicom Group, generating annual revenues of over $6 billion.

•

Experience in Leading Marketing Services Companies: Harrison’s tenure at DAS saw the division expand to over 5,000 worldwide clients, accounting for more than 50% of Omnicom’s total revenues. He acquired and led a group of companies that became influential in their respective disciplines.

•

Proven Track Record in Healthcare Advertising: Before joining Omnicom, Harrison co-founded Harrison & Star Business Group, which became the most successful and rapidly growing agency in the healthcare industry. His unique approach fused high science with high creativity, positioning the agency as a leader in the market.

•

Senior Operating Partner at Merida Capital Partners: In his current role, Harrison focuses on strategic and operational advising across Merida’s portfolio companies, contributing his expertise to the dynamic cannabis industry.

In addition to his role at Merida Capital Partners, Mr. Harrison serves on the boards of AFC Gamma and Acurx Pharmaceuticals.

“We are thrilled to welcome Tom Harrison to our Board of Directors,” said Garo Armen, PhD, Chairman and CEO of Agenus. “Tom’s extensive experience in healthcare advertising and strategic advising, combined with his proven leadership skills, will be invaluable as we continue to advance our mission of harnessing the power of the immune system to bring innovative therapies to patients.”

Educating the World About Agenus and Our Pipeline

As Agenus continues to develop its robust pipeline of novel immunotherapy candidates, the importance of effectively communicating our scientific advancements and therapeutic potential to a global audience cannot be overstated. Tom Harrison’s background in leading large-scale marketing and communications efforts uniquely positions him to drive these initiatives forward.

Harrison’s experience in healthcare advertising and branding will be instrumental in elevating Agenus’ visibility and reputation within the scientific and medical communities. His ability to convey complex scientific concepts in an accessible and compelling manner will help educate stakeholders, including healthcare providers, patients, investors, and regulatory bodies, about the groundbreaking work being conducted at Agenus.

“Tom’s expertise in strategic communications and his deep understanding of the healthcare landscape will play a critical role in our efforts to educate the world about Agenus’ innovative pipeline,” added Dr. Armen. “His leadership will be crucial as we strive to enhance awareness and understanding of our mission to improve patient outcomes through cutting-edge immunotherapies.”