|
|
|
|
|
(State or other jurisdiction
|
(Commission
|
(IRS Employer
|
|
of incorporation)
|
File Number)
|
Identification No.)
|
|
|
|
|
(Address of principal executive offices)
|
(Zip Code)
|
|
(Registrant’s telephone number, including area code)
|
|
|
|
Title of each class
|
|
Trading
Symbol(s)
|
|
Name of each exchange
on which registered
|
|
|
|
|
|
|
| Item 2.05 |
Costs Associated with Exit or Disposal Activities.
On August 23, 2023, Agenus Inc. announced a strategic alignment and streamlining of its operations to support near-term clinical development,
regulatory activities, and preparations for commercialization of its lead program of botensilimab and balstilimab. As part of this effort, Agenus Inc. (excluding its independently operating subsidiaries) is reducing its workforce by
approximately 25%, which the company expects to result in savings of approximately $2.8 million by year-end, after accounting for the cost of the workforce reduction of approximately $1.4 million. The workforce reductions are cash-based
expenditures related primarily to severance payments. The company expects to recognize substantially all charges related to the workforce reduction in the quarter ending September 30, 2023. Beyond workforce reductions, the company
expects to reduce spending by approximately $40 million by year-end 2023 on programs and activities outside of its strategic focus on botensilimab and balstilimab. These estimates are subject to assumptions and actual results may differ.
In connection with the announcement, the Company issued a press release, which is being included as Exhibit 99.1 to this current report on Form 8-K.
|
|
|
AGENUS INC. |
|
|
|
|
|
| Date: August 23, 2023 | By: | /s/ Christine M. Klaskin |
|
|
|
|
|
|
|
Christine M. Klaskin |
|
|
|
VP, Finance |
Strategic Prioritization to Deliver Savings of $40M Through End of 2023
LEXINGTON, Mass.--(BUSINESS WIRE)--August 23, 2023--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a pioneer in immuno-oncology, today announced a strategic initiative to prioritize and focus resources to accelerate the development, registration, and commercialization of its flagship program botensilimab/balstilimab (BOT/BAL). Under this new plan, Agenus will temporarily postpone all preclinical and clinical programs not related to BOT/BAL. The plan will result in a workforce reduction of approximately 25% and deliver approximately $40 million in savings by the end of 2023.
The plan will reduce operating expenses across Agenus' global organization by concentrating its quality, manufacturing, clinical, regulatory, and research & development resources on the BOT/BAL program and drive commercial readiness.
"Now is the pivotal moment to concentrate our efforts on the BOT/BAL program. The observed clinical benefit in solid tumors underscores the program’s game-changing potential, and our rapid progress towards a first filing in 2024 highlights the necessity for prioritization in every aspect of our operations," said Chairman and Chief Executive Officer, Garo Armen, Ph.D. "By zeroing in on BOT/BAL, we expect to expedite regulatory approval and availability for healthcare providers and patients in need. Our decision to streamline operations reflects our commitment to the success of these programs while optimizing shareholder value."
"We deeply value the contributions of our employees and regret the necessity of these difficult decisions," Armen continued. "We are thankful for their dedication and hard work, and we are committed to providing support to those affected during this transition."
Agenus remains dedicated to its deep pipeline of immuno-oncology agents and plans to reactivate these programs in the future. Agenus’ partner-funded programs will not be affected by these measures.
About Botensilimab
Botensilimab, an investigational multifunctional CTLA-4 antibody, is designed to extend immunotherapy benefits to "cold" tumors, which have not historically responded to standard of care or other investigational therapies. Besides binding to the CTLA-4 receptor, its Fc-enhanced structure induces a memory immune response, downregulates regulatory T cells, and activates T cells, thereby enhancing immune responses. Approximately 600 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ 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 and infectious diseases with a comprehensive pipeline of immunological agents. The company’s 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 is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or follow us on LinkedIn and Twitter @agenus_bio.
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 anticipated savings as a result of the strategic initiative, the timing of potential regulatory applications, approval and commercialization for BOT/BAL, the continued development of Agenus’ partnered programs, the reactivation of certain pipeline programs, use of botensilimab and balstilimab, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action (including validation of mechanism of action), potency, durability, and safety profile (including the absence of specific toxicities); 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 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.
Investors
Zack Armen
Head of Investor Relations
917-362-1370
zack.armen@agenusbio.com
Media
781-674-4784
communications@agenusbio.com
Document and Entity Information |
Aug. 23, 2023 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Aug. 23, 2023 |
| Entity File Number | 000-29089 |
| Entity Registrant Name | AGENUS INC. |
| Entity Central Index Key | 0001098972 |
| Entity Incorporation, State or Country Code | DE |
| Entity Tax Identification Number | 06-1562417 |
| Entity Address, Address Line One | 3 Forbes Road |
| Entity Address, City or Town | Lexington |
| Entity Address, State or Province | MA |
| Entity Address, Postal Zip Code | 02421 |
| City Area Code | 781 |
| Local Phone Number | 674-4400 |
| Title of 12(b) Security | Common Stock, $0.01 par value per share |
| Trading Symbol | AGEN |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
-8?20$3;8T.P6BP^0"X99K>]9!:G