0001144204-18-042997.txt : 20180809 0001144204-18-042997.hdr.sgml : 20180809 20180809081246 ACCESSION NUMBER: 0001144204-18-042997 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20180809 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20180809 DATE AS OF CHANGE: 20180809 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: 181003507 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 tv500554_8k.htm 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

 

August 9, 2018

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 (Commission (IRS Employer
of incorporation) File Number) 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)

 

 

 

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 (see General Instruction A.2. below):

 

¨ 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))

 

 

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 o

 

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. o

 

 

 

 

Item 2.02Results of Operations and Financial Condition.

 

On August 9, 2018, Agenus Inc. announced its financial results for the quarter ended June 30, 2018. The full text of the press release issued in connection with the announcement 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 9.01Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibit is furnished herewith:

 

99.1Press Release dated August 9, 2018

 

 

 

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.


AGENUS INC.

 



Date: August 9, 2018 By: /s/ Christine M. Klaskin 


Christine M. Klaskin
VP, Finance

 

 

 

 

EXHIBIT INDEX

 

 

Exhibit No. Description of Exhibit
   
99.1 Press Release dated August 9, 2018

 



EX-99.1 2 tv500554_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

Agenus Reports Second Quarter 2018 Financial Results and Provides Corporate Update



- Cash milestones earned from Merck & Incyte  

- Three INDs filed and 3 more to be filed during 2018

- CTLA-4 & PD-1 trials treated more than 115 patients; clinical benefit confirmed

LEXINGTON, Mass., Aug. 9, 2018 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, provided a corporate update and reported financial results for the second quarter of 2018.

"Innovation and speed are core to our strategy. We have delivered eight new discoveries over the past 2 years. This year alone, 3 INDs from our discovery engines have been filed and 3 additional INDs will be filed by year end; they include our NexGen CTLA-4 and our first-in-class bispecifics. We have delivered on our partnership commitments with Merck and Incyte with 2 programs in the clinic this year and a third expected before the end of the year, each triggering a cash milestone," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "In addition, our proprietary CTLA-4 and PD-1 programs are advancing in three trials designed to take advantage of accelerated pathways for a BLA filing as early as 2020. Our partnership discussions have advanced towards potential closure. With these developments, we expect to deliver value to our shareholders and partners."

Key clinical and business updates

  • Operational Achievements:
    • New discoveries advance to clinic
      • Three INDs filed and 3 more to be filed by the end of 2018, including Next-Gen CTLA-4 and two first-in-class bispecifics
    • Lead CTLA-4 (AGEN1884) & PD-1 (AGEN2034) trials advance towards BLA as early as 2020
      • ASCO reported data show 31-42% benefit
      • New data in 2018 anticipated to show expanded benefit
      • Three trials ongoing designed to leverage accelerated pathways
    • Payment milestones triggered in partnerships with Incyte, Merck
      • LAG-3 (INCAGN02385) in the clinic
      • TIM-3 (INCAGN02390) expected to enter clinic in 2018
      • Undisclosed target with Merck entered clinic
      • Sales of GSK's Shingrix, containing QS-21 Stimulon®, have exceeded projections 
  • Manufacturing Speed and Innovation:
    • Completed clinical & pivotal grade material for AGEN1884 & AGEN2034 3-5x faster than industry standards
    • First-in-class bispecific, AGEN1223, manufactured at scale in <2 months; setting industry records
  • AgenTus Cell Therapy Business:
    • Lead identified for IND filing; private financing and plans for IPO underway

Second Quarter 2018 Financial Results

Cash and cash equivalents were $43.2 million and $60.2 million at June 30, 2018 and December 31, 2017 respectively.

For the second quarter ended June 30, 2018, we reported a net loss of $25.2 million, or $0.24 per share, compared to a net loss for same period in 2017 of $31.7 million, or $0.32 per share. We recognized revenue during the current quarter of $16 million which includes milestone achievements and non-cash royalties earned.

For the six months ended June 30, 2018, we reported a net loss of $79.5 million or $0.76 per share compared to a net loss for the same period in 2017 of $48.8 million or $0.51 per share. The increased net loss reflects reduced revenue due to an accelerated milestone received during 2017 from Incyte and the loss on early extinguishment of debt.

Conference Call, Webcast and Prepared Statement Information

Agenus executives will host a conference call on Thursday, August 9, 2018 at 8:30 a.m. Eastern Time. To access the live call, dial (844) 492-3727 (domestic) and (412) 317-5118 (international). Ask to be joined into the Agenus call. The call will also be webcast and will be accessible from the Company's website at http://investor.agenusbio.com/presentation-webcasts or via the following link: https://www.webcaster4.com/Webcast/Page/1556/26916. A replay will be available on the Company's website approximately two hours after the call and will remain available for 90 days.

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, proprietary cancer vaccine platforms, and adoptive cell therapies (through its AgenTus Therapeutics subsidiary). 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 early phase 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.

About AgenTus Therapeutics, Inc.

AgenTus Therapeutics, a subsidiary of Agenus, is a preclinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of breakthrough "living drugs" to advance potential cures for cancer patients. AgenTus employs naturally-derived and engineered receptors, specifically T cell receptors (TCRs) and Chimeric Antigen Receptors (CARs), designed to supercharge human immune effector cells to seek and destroy cancer. AgenTus also aims to advance adoptive cell therapy formats which would enable off-the-shelf living drugs. AgenTus has locations in Lexington, MA and Cambridge, UK. For more information, please visit www.agentustherapeutics.com.

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 Agenus' plans to file additional INDs in 2018 and 2019, timing of partner trials and related milestone payments to Agenus, Agenus' plans to file a BLA as early as 2020, Agenus' plans to present new data in 2018 that shows expanded benefit, Agenus' expectation to deliver value to its shareholders and partners, and financing and development plans for AgenTus. 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 Buell, PhD
781-674-4420
Jennifer.Buell@agenusbio.com

1 Through AgenTus Therapeutics, a subsidiary of Agenus

Select Financial Information





(in thousands, except per share data)





(unaudited)






















June 30, 2018


December 31, 2017

















Cash and cash equivalents

$       43,164


$      60,187





Total assets

131,936


138,402






















Three months ended June 30,


Six months ended June 30,






2018


2017


2018


2017













Revenues, research and development

$       10,473


$        4,208


$ 12,109


$ 11,163

Revenues, non-cash royalty

5,422


-


5,422


-

Revenues, accelerated milestone

-


-


-


20,000

Research and development expenses

29,274


25,824


58,715


58,464

G&A expenses

9,485


8,136


18,413


15,906

Other expenses, net

8,632


2,825


10,377


6,670

Loss on early extinguishment of debt

-


-


10,767


-

Non-cash contingent consideration fair value adjustment

(6,292)


(865)


(1,276)


(1,061)

Net loss

(25,204)


(31,713)


(79,465)


(48,816)

Net loss per share

$         (0.24)


$          (0.32)


$   (0.76)


$   (0.51)



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