AGEN Agenus Inc

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):February 20, 2015    

AGENUS INC.
(Exact name of registrant as specified in its charter)

Registrant’s telephone number, including area code 781-674-4400

N/A
(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 (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))

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

As previously disclosed, Agenus Inc. (the “Company”) is party to a Note Purchase Agreement dated April 15, 2013, pursuant to which the Company issued to certain investors (the “Existing Investors”) (i) senior subordinated promissory notes in the aggregate principal amount of $5.0 million that were scheduled to mature on April 14, 2015 (the “2013 Notes”) and (ii) warrants to purchase 500,000 shares of the Company’s common stock.

On February 20, 2015, the Company, the Existing Investors and certain additional investors entered into an Amended and Restated Note Purchase Agreement (the “Purchase Agreement”), pursuant to which the Company (i) cancelled the 2013 Notes in exchange for new senior subordinated promissory notes (the “2015 Notes”) in the aggregate principal amount of $5.0 million, (ii) issued additional 2015 Notes in the aggregate principal amount of $9.0 million and (iii) issued warrants to purchase 1,400,000 shares of the Company’s common stock (the “Warrants”).  

The 2015 Notes bear interest at a rate of 8% per annum, payable in cash on the first day of each month in arrears. Among other default and acceleration terms customary for indebtedness of this type, the 2015 Notes include default provisions which allow for the acceleration of the principal payment of the 2015 Notes in the event the Company becomes involved in certain bankruptcy proceedings, becomes insolvent, fails to make a payment of principal or (after a grace period) interest on the 2015 Notes, defaults on other indebtedness with an aggregate principal balance of $13.5 million or more if such default has the effect of accelerating the maturity of such indebtedness, or becomes subject to a legal judgment or similar order for the payment of money in an amount greater than $13.5 million if such amount will not be covered by third-party insurance. The 2015 Notes are not convertible and will mature on February 20, 2018, at which point the Company must repay the outstanding balance in cash. The Company may prepay the 2015 Notes at any time, in part or in full, without premium or penalty.

The Warrants have a term of five years and an exercise price of $5.10 per share.

The securities issued in connection with the Purchase Agreement were issued in reliance on the exemption from registration provided by Section 4(2) of the Securities Act of 1933, as amended (the “Securities Act”). Neither the Warrants nor the underlying shares of common stock have been registered under the Securities Act. Neither the Warrants nor such underlying shares of common stock may be offered or sold in the United States absent registration or an applicable exemption from registration requirements. No commission or other remuneration was paid or given directly or indirectly for soliciting such issuance.

Item 2.02 Results of Operations and Financial Condition.

On February 26, 2015, the Company announced its financial results for the quarter and year ended December 31, 2014. 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 3.02 Unregistered Sales of Equity Securities.

The information provided above under Item 2.03 of this Current Report on Form 8-K is hereby incorporated by reference into this Item 3.02.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

(b)  On February 23, 2015, Tom Dechaene, a member of the Company’s board of directors (the “Board”), informed the Company of his intention to resign from the Board effective as of December 31, 2015. Mr. Dechaene will continue to serve as a director until such date. Mr. Dechaene’s decision is required by his role as an executive director of the National Bank of Belgium and is not due to any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.

Item 9.01 Financial Statements and Exhibits.

          (d) Exhibits

          The following exhibit is furnished herewith:

                        99.1     Press Release dated February 26, 2015

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 INDEX

Exhibit No.          Description of Exhibit

99.1                      Press Release dated February 26, 2015

Exhibit 99.1

Agenus Reports Fourth Quarter and Full Year 2014 Financial Results

Agenus to host conference call at 11 a.m. ET today

LEXINGTON, Mass.--(BUSINESS WIRE)--February 26, 2015--Agenus Inc. (NASDAQ:AGEN), an immunology company developing novel therapeutic approaches based on checkpoint modulators (CPMs), heat shock protein-based vaccines, and immune adjuvants, today announced its financial results and business highlights for the fourth quarter and year ended December 31, 2014.

“2014 was a transformative year for Agenus on many levels,” said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. “We started the year with the acquisition of privately held 4-Antibody AG, which brought us into the critically important field of checkpoint modulators. Through this acquisition, Agenus acquired our Retrocyte Display^TM technology, for the generation of antibody therapeutics, as well as a broad portfolio of checkpoint programs. In April, we announced a collaboration and license agreement with Merck around two undisclosed checkpoint targets, with Agenus eligible to receive up to $100 million in milestone payments as well as royalties on product sales. In June, we reported positive data from a Phase 2 study of our heat shock protein-based synthetic vaccine (HerpV) for the treatment of genital herpes, and shortly thereafter we announced positive results from a Phase 2 study of our heat shock-protein-based autologous vaccine (Prophage) in patients with newly diagnosed glioblastoma multiforme (GBM). In addition, our partner GlaxoSmithKline’s application for regulatory review of its malaria vaccine candidate, RTS,S, was accepted by the European Medicines Agency. The application was based on positive Phase 3 data for RTS,S, which contains Agenus’ proprietary QS-21 Stimulon^® adjuvant. In December, GlaxoSmithKline reported that its Phase 3 study with shingles vaccine candidate HZ/su, which also contains Agenus’ proprietary QS-21 Stimulon^® adjuvant, met its primary endpoint and reduced the risk of shingles by an unprecedented 97.2% in adults aged 50 years and older compared to placebo. Building on our achievements in 2014, we started 2015 with a transformative global oncology alliance with Incyte that includes, but is not limited to, four of our checkpoint programs. We look forward to executing on our alliances with Incyte and Merck, and expanding our portfolio of antibody-based therapeutics as we pursue the development of novel single agent and combination therapies for cancer patients.”

“Supporting these initiatives has required a growth in the breadth and depth of our R&D capabilities, including the assembly of a world-class translational biology team,” said Robert Stein, M.D., Ph.D., Chief Scientific Officer of Agenus. “We believe our partnership with Incyte leverages their track record of success in the discovery and development of important new cancer therapies, with our therapeutic antibody expertise, as well as our shared objectives in immuno-oncology. Our alliance aims to accelerate the development of novel checkpoint modulators in oncology, as single agent and combination therapies, while also allowing Agenus the ability to independently advance other antibody therapies and heat shock protein-based vaccines.”

Fourth Quarter 2014 and Full Year Financial Update

Cash, cash equivalents and short-term investments were $40.2 million as of December 31, 2014. Subsequent to year-end, the company received an additional $60 million from its global alliance with Incyte.

For the fourth quarter, Agenus reported a net loss attributable to common stockholders of $26.0 million, including $14.3 million of non-cash charges, or $0.41 per share, basic and diluted, compared with a net loss attributable to common stockholders for the fourth quarter of 2013 of $5.8 million, or $0.16 per share, basic and diluted.

For the year ended December 31, 2014, the company incurred a net loss attributable to common stockholders of $42.7 million, or $0.71 per share, basic and diluted, compared with a net loss attributable to common stockholders of $33.2 million, or $1.12 per share, basic and diluted, for the comparable period in 2013.

The increase in net loss attributable to common stockholders for the year ended December 31, 2014, compared to the net loss attributable to common stockholders for the same period in 2013, was primarily due to our acquisition of 4-Antibody AG in February 2014. In addition to increased operating expenses, we recorded non-cash expense of $6.7 million due to the fair value adjustment of the contingent purchase price consideration and non-cash income of $3.1 million related to the results of various trials of QS-21 Stimulon containing vaccines at GlaxoSmithKline.

During the same period of 2013, the company’s preferred stock restructuring resulted in a non-cash deemed dividend of $2.9 million, and the retirement of its then outstanding $39 million 8.0% senior secured convertible notes due August 2014 resulted in a non-cash expense of $3.3 million.

The increased net loss attributable to common stockholders for the quarter ended December 31, 2014, compared to the net loss attributable to common stockholders for the same period in 2013, was as well due to increased expenses related to our acquisition of 4-Anitbody AG. We also recorded non-cash expenses for the quarter ended December 31, 2014 of $6.6 million, due to the fair value adjustment of the contingent purchase price consideration, and $7.7 million related to the fair value adjustment of our contingent royalty obligation.

2014 Highlights:

• January: Agenus signed a definitive agreement to acquire privately held 4-Antibody AG, with its proprietary Retrocyte Display^TM technology and a broad preclinical portfolio of checkpoint modulators targeting GITR, OX40, TIM-3 and LAG-3, among others. The acquisition closed in February 2014.
• February: Agenus closed a public offering that resulted in net proceeds of approximately $56 million.
• April: Agenus entered into a collaboration and license agreement with Merck, involving generation by Agenus of fully human antibodies against two undisclosed checkpoint targets from Merck, in exchange for up to $100 million in potential milestones, as well as royalties on worldwide product sales.

• June: Agenus announced positive data from a randomized double blind Phase 2 study involving its heat shock protein-based vaccine candidate, HerpV, for the treatment of adult genital herpes. The study showed a statistically significant reduction in viral load in the more than half of patients who generated a robust anti-HSV cytotoxic T-cell immune response.
• July: Agenus announced positive data from a single arm Phase 2 study involving its heat shock protein-based autologous vaccine, Prophage, in the setting of GBM. The data showed patients treated with Prophage achieved a median overall survival of 23.8 months, compared with the historical expectation of about 16 months median survival with the standard of care. Subsequently, an end of Phase 2 meeting was held with the FDA.
• July: The EMA accepted GlaxoSmithKline’s application for regulatory review of its malaria vaccine candidate, RTS,S, based on positive data from a large Phase 3 study involving over 16,000 children. The vaccine contains Agenus’ proprietary QS-21 Stimulon® adjuvant, and Agenus is eligible to receive low single digit royalties on any future product sales.
• December: Agenus announced positive data from our partner GlaxoSmithKline’s ZOE-50 Phase 3 trial involving its HZ/su vaccine candidate for the prevention of shingles in adults aged 50 and over. The study showed an unprecedented 97.2% efficacy rate in the prevention of shingles compared to placebo. Full study results will be submitted for publication this year and presented at a forthcoming medical conference. The vaccine candidate contains Agenus’ proprietary QS-21 Stimulon® adjuvant, and Agenus is eligible to receive low single digit royalties on any future product sales.

Target Milestones for 2015 include:

• Publication of the Phase 2 data for Prophage in newly diagnosed GBM in a peer reviewed journal. Explore options for the advancement of Prophage for newly diagnosed GBM to a Phase 3 trial.
• Full Phase 3 data for partner GlaxoSmithKline’s HZ/su shingles vaccine are expected to be presented at a scientific conference and submitted for publication in a peer-reviewed journal. The vaccine contains Agenus’ proprietary QS-21 Stimulon® adjuvant.
• EMA regulatory decision on GlaxoSmithKline’s malaria vaccine candidate RTS,S, which contains Agenus’s QS-21 Stimulon® adjuvant.
• File Investigational New Drug (IND) applications for two checkpoint modulator antibody programs as part of our global oncology alliance with Incyte.

Conference Call and Web Cast Information

Agenus executives will host a conference call at 11:00 a.m. Eastern Time today. To access the live call, dial 866-233-4585 (U.S.) or 416-640-5946 (international). The live and archived webcast of the presentation will be accessible from the Company’s website at www.agenusbio.com/webcast. Please log in approximately 5-10 minutes before the call to ensure a timely connection. The archived replay will be available on the Agenus website for 60 days. The replay number is 866-245-6755 (U.S.) or 416-915-1035 (international), and the access code is 55109. The replay will also be available on the Company’s website approximately two hours after the live call.

About Agenus

Agenus is an immunology company developing a series of immuno-oncology CPMs, heat shock protein peptide-based vaccines and immune adjuvants. These programs are supported by three separate technology platforms. Agenus’ checkpoint modulator programs target GITR, OX40, CTLA-4, LAG-3, TIM-3 and PD-1. The Company’s proprietary discovery engine Retrocyte Display^TM is used to generate fully human and humanized therapeutic antibody drug candidates. The Retrocyte Display^TM platform uses a high-throughput approach incorporating IgG format human antibody libraries expressed in mammalian B-lineage cells. Agenus’ heat shock protein vaccines have completed Phase 2 studies in newly diagnosed glioblastoma multiforme, and in the treatment of herpes simplex viral infection; the heat shock protein platform can generate personalized as well as off the shelf products. The Company’s QS-21 Stimulon® adjuvant platform is extensively partnered with GlaxoSmithKline and Janssen Sciences Ireland UC and includes several candidates in Phase 2, as well as shingles and malaria vaccines which have successfully completed Phase 3 clinical trials. For more information, please visit www.agenusbio.com, or connect with the company on Facebook, LinkedIn, Twitter and Google+.

Forward-Looking Statement

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 Company’s research and development and clinical trial activities, potential revenue streams, potential regulatory approvals, the potential application of the Company’s technologies and product candidates in the prevention and treatment of diseases, plans to execute on the Company’s alliances with Incyte and Merck, the expected timing for filing IND applications for CPM antibody candidates, the submission and publication of data in peer-reviewed journals and presentations of data at scientific conferences. 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.
Media:
BMC Communications
Brad Miles, 646-513-3125
bmiles@bmccommunications.com
or
Investors:
Argot Partners
Andrea Rabney/ Jamie Maarten
212-600-1902
andrea@argotpartners.com
jamie@argotpartners.com