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
October
24, 2013
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) |
(IRS 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)
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 2.02 |
Results of Operations and Financial Condition |
|
On October 24, 2013, Agenus Inc. announced its financial results for the quarter ended September 30, 2013. 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. |
||
Item 9.01 |
Financial Statements and Exhibits |
(d) Exhibits |
|
The following exhibit is furnished herewith: |
|
99.1 Press Release dated October 24, 2013 |
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: |
October 24, 2013 |
By: |
/s/ Christine M. Klaskin |
|
|
||||
Christine M. Klaskin |
||||
VP, Finance |
EXHIBIT INDEX
Exhibit No. Description
of Exhibit
99.1 Press Release dated
October 24, 2013
Exhibit 99.1
Agenus Reports Third Quarter 2013 Financial Results
Agenus to host conference call beginning at 11 a.m. ET today
LEXINGTON, Mass.--(BUSINESS WIRE)--October 24, 2013--Agenus Inc. (NASDAQ: AGEN), a biotechnology company working to develop novel immunology based treatments for cancers and infectious diseases, today announced its financial results and business highlights for the third quarter ended September 30, 2013.
“Recently, we achieved important milestones in both QS-21 Stimulon®1 adjuvant-containing programs as well as our Prophage Phase 2 newly diagnosed brain cancer trial. We are gratified to have contributed to the clinical success of the world’s most advanced malaria vaccine candidate with QS-21 Stimulon. We believe this important proof of efficacy could potentially lead to a string of clinical successes in coming years,” said Garo H. Armen, Ph.D., chairman and CEO of Agenus. “Through our own efforts and those of our partners, we remain committed to advancing our heat shock protein platform, QS-21 Stimulon programs, and additional immunotherapy product candidates over the next several years. In the near-term, we look forward to reporting Phase 2 data for HerpV, a therapeutic vaccine for the treatment of genital herpes, and Phase 3 results from GSK’s MAGE-A3 non-small cell lung cancer trial.”
The company’s net loss attributable to common stockholders for the third quarter of 2013 was $7.4 million, or $0.24 per share, basic and diluted, compared to a net loss attributable to common stockholders of $5.9 million, or $0.24 per share, basic and diluted, for the third quarter of 2012.
For the nine months ended September 30, 2013, the company reported a net loss attributable to common stockholders of $27.4 million, or $0.99 per share, basic and diluted, compared with a net loss attributable to common stockholders of $6.5 million, or $0.28 per share, basic and diluted, for the nine months ended September 30, 2012.
As a result of various corporate transactions, net loss for the nine months ended September 30, 2013 increased compared to the net loss for the same period in 2012 primarily due to $6.2 million of non-recurring non-cash charges incurred during 2013 and one-time payments of $13.4 million received during 2012. In the first quarter of 2013, the company’s preferred stock restructuring, which reduced the dividend requirements for its Series A-1 preferred securities, resulted in a non-cash deemed dividend of $2.9 million. In the second quarter of 2013, the company retired its outstanding $39 million 8.0% senior secured convertible notes due August 2014 resulting in a non-cash loss on extinguishment of debt of $3.3 million. In the first quarter of 2012, revenue of $13.4 million was generated primarily due to one-time payments received through an expanded agreement with GlaxoSmithKline (GSK) and through a license of non-core technologies.
Cash and cash equivalents were $30.2 million as of September 30, 2013.
Recent and Third Quarter 2013 Highlights
Between Agenus and its partners, a total of 23 vaccine programs are in clinical development of which 21 contain QS-21 Stimulon. They include, but are not limited to:
Agenus’ pipeline programs include:
Saponin Platform: QS-21 Stimulon® Adjuvant
Agenus’ QS-21 Stimulon adjuvant is one of the most widely tested vaccine adjuvants in clinical development. QS-21Stimulon is designed to strengthen the body's immune response to a vaccine's antigen, thus making it more effective. QS-21 Stimulon is a key component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, and appears to play an important role in several investigational therapeutic vaccines intended to treat cancer and degenerative disorders. Licensees of QS-21 Stimulon include GSK and Janssen Alzheimer Immunotherapy. Agenus is generally entitled to receive milestone payments as QS-21Stimulon-containing programs advance, as well as royalties for 10 years after commercial launch, with some exceptions.
Heat Shock Protein Platform (HSP): Recombinant Series HerpV
HerpV is a recombinant therapeutic vaccine candidate for the treatment of genital herpes, which is caused by the herpes simplex virus-2 (HSV-2). HerpV, one of the most clinically advanced HSV-2 therapeutic vaccine candidates in development, is currently in a Phase 2 randomized, double-blind, multicenter study. The Phase 2 data are anticipated during the fourth quarter of 2013. The vaccine is based on Agenus' HSP platform technology, and contains Agenus’ proprietary QS-21 Stimulon adjuvant.
HerpV consists of recombinant human heat shock protein-70 complexed with 32 distinct 35-mer synthetic peptides from the HSV-2 proteome. This broad spectrum of herpes antigens is intended to allow for more accurate immune targeting and surveillance, reducing the likelihood of immune escape. Further, the diversity of antigens in HerpV increases the chance of providing efficacy for a wide segment of the patient population.
In a four-arm, Phase 1 study, 35 HSV-2 seropositive patients received HerpV (designated in the study as AG-707 plus QS-21), AG-707, QS-21 alone, or placebo. Patients received three treatments at two-week intervals. The vaccine was generally well tolerated, with injection site pain as the most common reported adverse event. All patients who received HerpV and were evaluable for immune response showed a statistically significant CD4+ T cell response (100%; 7/7) to HSV-2 antigens as detected by IFNγ Elispot, and the majority of those patients demonstrated a CD8+ T cell response (75%; 6/8). This study was published in the scientific journal Vaccine.
Heat Shock Protein Platform( HSP): Prophage Series Cancer Vaccines
Derived from each individual’s tumor, Prophage Series vaccines contain the ‘antigenic fingerprint’ of the patient’s particular cancer and are designed to reprogram the body’s immune system to target only cancer cells bearing this fingerprint. Prophage Series vaccines, based on our HSP platform technology, are intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy. The Prophage Series vaccines are currently being studied in both newly diagnosed and recurrent GBM.
Patient enrollment is underway for the large-scale, randomized Phase 2 trial of Prophage Series G-200 in combination with Avastin® in patients with surgically resectable recurrent GBM. This trial is investigating the combination of G-200 and Avastin in a three-arm randomized study of 222 patients with surgically resectable recurrent GBM. The study will compare efficacy of G-200 given with Avastin either concomitantly or at progression, versus Avastin alone.
For additional information please refer to www.clinicaltrials.gov or click on the following link http://www.clinicaltrials.gov/ct2/show/NCT01814813?term=HSPPC-96&rank=6
In addition to the recurrent GBM study, a Phase 2 trial testing the Prophage Series G-100 vaccine in patients with newly diagnosed GBM is ongoing. In this trial, G-100 is being used with the standard of care, which includes Temodar® (Merck; temozolomide) and radiation. It is believed that the efficacy of G-100 could potentially be enhanced through this combination regimen.
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 647-426-1845. The call will also be webcast and will be accessible from the company’s website at www.agenusbio.com/webcast/. A replay will be available approximately two hours after the call through midnight Eastern Time on December 23, 2013. The replay number is 416-915-1035 and the access code is 402191. The replay will also be available on the company’s website approximately two hours after the live call.
About Agenus
Agenus Inc. is a biotechnology company working to develop treatments for cancers and infectious diseases. The company is focused on immunotherapeutic products based on strong platform technologies with multiple product candidates advancing through the clinic, including several product candidates that have advanced into late-stage clinical trials through corporate partners. For more information, please visit www.agenusbio.com.
Forward-Looking Statement
This earnings release contains forward-looking statements, including statements regarding development and clinical trial activities, data read-outs and timelines of the company and its licensees and collaborators, potential benefit of product candidates in development, and potential revenue streams from our partnering and licensing arrangements. 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, decisions by regulatory authorities, physicians, patients, and our existing and potential licensees and collaborators; the possibility that clinical trial results will not be favorable; the inability to secure favorable partnering arrangements; the ability to raise capital; and the factors described under the Risk Factors section of our Annual Report on Form 10-Q filed for the period ended June 30, 2013 and other reports 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 document, and Agenus undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Agenus’ business is subject to substantial risks and uncertainties, including those identified above. When evaluating Agenus’ business and securities, investors should give careful consideration to these risks and uncertainties.
1. QS-21 Stimulon® adjuvant and the related agreements, and HerpV are assets of Antigenics Inc., a wholly owned subsidiary of Agenus Inc.
2. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med, 2005. 352(10): p. 987-96.
3. QS-21 Stimulon is a component of certain GSK adjuvant systems.
Stimulon is a registered trademark of Agenus Inc. and its subsidiaries. Avastin is a registered trademark of Genentech.
Summary Consolidated Financial Information | ||||||||||||||||||||||
Condensed Consolidated Statements of Operations Data (in thousands, except per share data) (unaudited) |
||||||||||||||||||||||
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||||||||
Revenue | $ | 736 | $ | 869 | $ | 2,653 | $ | 14,871 | ||||||||||||||
Operating expenses: | ||||||||||||||||||||||
Cost of sales | 80 | 217 | 529 | 369 | ||||||||||||||||||
Research and development | 3,893 | 2,606 | 9,764 | 8,194 | ||||||||||||||||||
General and administrative | 3,578 | 2,587 | 11,112 | 8,820 | ||||||||||||||||||
Operating (loss) income | (6,815 | ) | (4,541 | ) | (18,752 | ) | (2,512 | ) | ||||||||||||||
Other expense, net | 504 | 1,188 | 5,543 | 3,373 | ||||||||||||||||||
Net loss | (7,319 | ) | (5,729 | ) | (24,295 | ) | (5,885 | ) | ||||||||||||||
Dividends on Series A convertible preferred stock | (51 | ) | (198 | ) | (3,109 | ) | (593 | ) | ||||||||||||||
Net loss attributable to common stockholders | $ | (7,370 | ) | $ | (5,927 | ) | $ | (27,404 | ) | $ | (6,478 | ) | ||||||||||
Per common share data, basic and diluted: | ||||||||||||||||||||||
Net loss attributable to common stockholders | $ | (0.24 | ) | $ | (0.24 | ) | $ | (0.99 | ) | $ | (0.28 | ) | ||||||||||
Weighted average number of common shares outstanding, basic and diluted | 30,345 | 24,529 | 27,774 | 23,275 | ||||||||||||||||||
Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) |
||||||||||||||||||||||
September 30, 2013 | December 31, 2012 | |||||||||||||||||||||
Cash and cash equivalents | $ | 30,205 | $ | 21,468 | ||||||||||||||||||
Total assets | 37,670 | 29,093 | ||||||||||||||||||||
Total stockholders' deficit | (2,877 | ) | (17,600 | ) | ||||||||||||||||||
CONTACT:
Media and Investor Contact:
Agenus Inc.
Jonae
R. Barnes, 617-818-2985
Vice President
Investor Relations and
Corporate
Communications
jonae.barnes@agenusbio.com