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
March 5, 2014
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 March 5, 2014, Agenus Inc. announced its financial results for the quarter and year ended December 31, 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 8.01 |
Other Events |
Ludwig Cancer Research and Agenus Inc. today announced the selection of three monoclonal antibody checkpoint modulators (CPMs) that Agenus is advancing into preclinical development. These product candidates—two GITR agonists and a CTLA-4 antagonist—target cell-surface checkpoint proteins that control immune responses. The full text of the press release issued in connection with the announcement is being filed as Exhibit 99.2 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 Fourth Quarter and Full Year 2013 Press Release dated March 5, 2014
99.2 Checkpoint Modulator Press Release dated March 5, 2014
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. |
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|
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Date: March 5, 2014 |
By: |
/s/ Garo H. Armen |
|
Garo H. Armen |
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Chief Executive Officer |
EXHIBIT INDEX
Exhibit No. |
Description of Exhibit |
|
99.1 |
Fourth Quarter and Full Year 2013 Press Release dated March 5, 2014 |
|
99.2 |
Checkpoint Modulator Press Release dated March 5, 2014 |
Exhibit 99.1
Agenus Reports Fourth Quarter and Full Year 2013 Financial Results
Agenus to host conference call beginning at 11 a.m. ET today
LEXINGTON, Mass.--(BUSINESS WIRE)--March 5, 2014--Agenus Inc. (NASDAQ: AGEN), a biopharmaceutical company developing a portfolio of immuno-oncology candidates, including checkpoint modulators (CPMs), heat shock protein vaccines and adjuvants, today announced its financial results and business highlights for the fourth quarter and year ended December 31, 2013.
“We began 2014 with the acquisition of an exciting new platform of fully-human checkpoint antibodies. This platform has generated six lead discovery programs in immuno-oncology,” said Garo H. Armen, PhD, chairman and CEO of Agenus. “This transformative acquisition along with our strengthened balance sheet from our recent financing enables us to rigorously pursue our cancer immuno-oncology strategy with a broad portfolio of innovative products. I look forward to reporting progress from all of our platforms this year, which include QS-21 Stimulon adjuvant, heat shock protein vaccines and checkpoint modulators.”
On February 12, 2014, Agenus completed the acquisition of 4-Antibody AG, a private European-based biopharmaceutical company. The 4-Antibody assets include the Retrocyte Display® technology platform which is designed to enable rapid discovery and optimization of fully human antibodies against a wide array of molecular targets. 4-Antibody has applied Retrocyte Display to create therapeutic antibodies to six checkpoint targets that regulate immune response to cancers and other diseases. 4-Antibody has multiple preclinical immune CPM programs in development including GITR and OX40 agonists and antagonists of TIM-3, LAG-3, PD-1 and CTLA-4. These programs are being pursued through a strategic collaboration with the Ludwig Cancer Research.
Fourth Quarter 2013 and Full Year Financial Update
For the fourth quarter, Agenus reported a net loss attributable to common stockholders of $5.8 million, or $0.16 per share, basic and diluted, compared with a net loss attributable to common stockholders for the fourth quarter of 2012 of $5.6 million, or $0.23 per share, basic and diluted.
For the year ended December 31, 2013, the company incurred a net loss attributable to common stockholders of $33.2 million, or $1.12 per share, basic and diluted, compared with a net loss attributable to common stockholders of $12.1 million, or $0.51 per share, basic and diluted, for the comparable period in 2012.
Cash and cash equivalents were $27.4 million as of December 31, 2013. Subsequent to year end, the company’s cash position includes net proceeds of approximately $56 million from a registered public offering completed in the first quarter of 2014.
The increase in net loss attributable to common stockholders for the year ended December 31, 2013 compared to the net loss attributable to common stockholders for the same period in 2012, was 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 charge of $2.9 million. In the second quarter of 2013, the Company retired its outstanding 8.0% senior secured convertible notes due August 2014 in the principal amount of $39 million resulting in a non-cash loss of $3.3 million. In 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.
Recent and Fourth Quarter 2013 Highlights:
Additional milestones anticipated in 2014 include:
Checkpoint Antibody Platform
The company’s proprietary discovery engine Retrocyte Display® is capable of rapidly generating high quality therapeutic antibody drug candidates using a high-throughput approach incorporating full-length IgG format human antibody libraries expressed in mammalian B-lineage cells.
Heat Shock Protein Platform( HSP): Prophage Anti-Cancer Vaccines
The company’s individualized cancer vaccine platform produces therapeutic cancer vaccine candidates from each patient’s own tumor tissue. As a result of its individualized nature, each Prophage vaccine intends to contain the precise signals (antigenic fingerprint) of the patient’s particular cancer which is meant to engage the body’s immune system to target only cancer cells bearing this specific fingerprint. Such high precision in immunological targeting represents a distinctly different method for treating cancer compared to conventional anti-cancer treatments such as chemotherapy or radiation therapy without many of the side effects seen in conventional therapy.
Prophage is currently being studied in both newly diagnosed and recurrent GBM. Patient enrollment is underway for the large-scale, randomized Phase 2 trial of Prophage in combination with Avastin® in patients with surgically resectable recurrent GBM. This three-arm study of 222 patients will compare efficacy of Prophage 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
Heat Shock Protein Platform (HSP): 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). Positive preliminary results were reported from a Phase 2 randomized study during the fourth quarter of 2013 and post-booster results, along with immune response data, are anticipated in the first half of 2014. HerpV consists of recombinant human heat shock protein-70 complexed with 32 distinct 35-mer synthetic peptides from the HSV-2 proteome and contains QS-21 Stimulon.
Saponin Platform: QS-21 Stimulon Adjuvant
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 of 21 investigational vaccines for infectious diseases, cancers and degenerative disorders. Licensees include GSK and Janssen Alzheimer Immunotherapy. Agenus is generally entitled to receive milestone payments as well as royalties for 10 years after commercial launch.
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 May 5, 2014. The replay number is 416-915-1035 and the access code is 498676. The replay will also be available on the company’s website approximately two hours after the live call.
About Agenus
Agenus is a biopharmaceutical company developing a portfolio of immuno-oncology candidates, including checkpoint modulators (CPMs), heat shock protein vaccines and adjuvants. The company’s proprietary discovery engine Retrocyte Display® is designed to rapidly generate high quality therapeutic antibody drug candidates using a high-throughput approach incorporating full-length IgG format human antibody libraries expressed in mammalian B-lineage cells. A portfolio of checkpoint modulator programs is advancing in preclinical development. The company’s heat shock protein vaccines for cancer and infectious disease are in Phase 2 studies. Agenus’ QS-21 Stimulon adjuvant platform is extensively partnered with GlaxoSmithKline and Janssen and includes several candidates in Phase 3 trials. Among Agenus and its partners, 23 programs are in clinical development. 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, including statements regarding the potential impact of the 4-Antibody acquisition on the company’s business, preclinical and clinical trial activities, the publication of data, and the potential application of the Company’s technologies and product candidates in the prevention and treatment of diseases. 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended September 30, 2013. 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.
Yervoy is a registered trademark of Bristol-Myers Squibb. Retrocyte Display is a registered trademark of 4-Antibody AG. 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 December 31, | Year ended December 31, | |||||||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||||||
Revenue | $ | 393 | $ | 1,090 | $ | 3,045 | $ | 15,961 | ||||||||||||
Operating expenses: | ||||||||||||||||||||
Cost of revenue | 7 | 303 | 536 | 672 | ||||||||||||||||
Research and development | 3,241 | 2,371 | 13,005 | 10,565 | ||||||||||||||||
General and administrative | 3,372 | 2,645 | 14,484 | 11,465 | ||||||||||||||||
Operating loss | (6,227 | ) | (4,229 | ) | (24,980 | ) | (6,741 | ) | ||||||||||||
Other expense, net | (450 | ) | 1,211 | 5,093 | 4,584 | |||||||||||||||
Net loss | (5,777 | ) | (5,440 | ) | (30,073 | ) | (11,325 | ) | ||||||||||||
Dividends on Series A convertible preferred stock | (50 | ) | (199 | ) | (3,159 | ) | (792 | ) | ||||||||||||
Net loss attributable to common stockholders | $ | (5,827 | ) | $ | (5,639 | ) | $ | (33,232 | ) | $ | (12,117 | ) | ||||||||
Per common share data, basic and diluted: | ||||||||||||||||||||
Net loss attributable to common stockholders | $ | (0.16 | ) | $ | (0.23 | ) | $ | (1.12 | ) | $ | (0.51 | ) | ||||||||
Weighted average number of common shares outstanding, basic and diluted | 35,676 | 24,682 | 29,766 | 23,629 | ||||||||||||||||
Condensed Consolidated Balance Sheet Data |
||||||||||||||||||||
(in thousands) |
||||||||||||||||||||
(unaudited) |
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December 31, 2013 | December 31, 2012 | |||||||||||||||||||
Cash and cash equivalents | $ | 27,352 | $ | 21,468 | ||||||||||||||||
Total assets | 34,835 | 29,093 | ||||||||||||||||||
Total stockholders' deficit | (4,481 | ) | (17,600 | ) | ||||||||||||||||
CONTACT:
Agenus Inc.
Media and Investors:
Investor Relations &
Corporate
Communications
Jonae R. Barnes, 617-818-2985
Vice President
Exhibit 99.2
Agenus to Advance Three Checkpoint Modulator Antibodies into Development
NEW YORK & LEXINGTON, Mass.--(BUSINESS WIRE)--March 5, 2014--Ludwig Cancer Research and Agenus Inc. (NASDAQ: AGEN) today announced the selection of three monoclonal antibody checkpoint modulators (CPMs) that Agenus is advancing into preclinical development. These product candidates—two GITR agonists and a CTLA-4 antagonist—target cell-surface checkpoint proteins that control immune responses. They are part of Agenus’ recent acquisition of 4-Antibody AG and the result of several years of intensive collaborative efforts between 4-Antibody and Ludwig Cancer Research. The parties also have ongoing programs to discover and develop other immune checkpoint modulator antibodies, including OX40 agonists and antagonists of LAG-3, TIM-3 and PD-1.
“GITR, a checkpoint protein on T-lymphocytes, plays an important role in amplifying specific cellular immune responses, including those against tumors. We are encouraged to have identified high-quality agonist antibodies for this very competitive target, something that has proven difficult for many other companies,” said Robert B. Stein, MD, PhD, Chief Scientific Officer of Agenus. “Furthermore, it is rational to combine CPMs such as CTLA-4 and PD-1 antagonists with anti-cancer vaccines, and we are collaborating on an on-going Phase 2 trial exploring Prophage and Yervoy® (CTLA-4 antagonist) in patients with metastatic melanoma. Intelligently designed translational studies may improve the odds of success for our CPMs and accelerate their clinical development.”
In collaboration with its translational research partner Ludwig Cancer Research, Agenus and 4-Antibody plan to advance the emerging portfolio of CPMs as single agents and in optimized combinations, including potential combinations with the company’s anti-cancer vaccine and other agents.
“The Retrocyte Display®1 technology developed by 4-Antibody over the last decade has allowed us to create attractive CPM antibodies directed against key checkpoint targets,” said Robert Burns, PhD, CEO of 4-Antibody. “By combining our know-how with Agenus’ immunotherapy development expertise, we expect to propel these candidates through preclinical and clinical development.”
“The collaboration with 4-Antibody allowed us to rapidly advance antibodies into development,” said Jonathan Skipper, Ludwig’s Executive Director of Technology Development. “We are now planning clinical studies to evaluate novel combinations of these antibodies. Ludwig has been at the forefront of translational research in immuno-oncology for several decades. Our ongoing relationship with Agenus is a good example of our broader strategy to advance cancer therapy.”
CPMs like CTLA-4 and PD-1 antagonists make cancer more vulnerable to immune attack by releasing the brakes on the anti-cancer immune response and neutralizing the defenses cancer cells use to fend off that attack. Cancer vaccines, meanwhile, are designed to enhance the immune system’s recognition of cancer cells as abnormal based on mutant proteins that they display. Scientists reason that, together, these strategies should deliver a one-two punch against cancer that could have a durable therapeutic impact.
About Checkpoint Modulators
Promising clinical data from studies employing monoclonal antibodies that bind to checkpoint molecules, such as cytotoxic T lymphocyte antigen-4 (CTLA-4) and programmed death receptor-1 (PD-1), have generated considerable excitement in the field of cancer immunotherapy. These molecules serve as checks employed by the body to prevent a runaway immune response, which can be debilitating, and even deadly. Unfortunately, these necessary mechanisms of control can hinder the anti-cancer immune response. They can be harnessed by cancer cells as a defense against immune attack. Antibodies that bind PD-1 and CTLA-4 and antagonize their activities are designed to override these control mechanisms, disengaging the immune system’s brakes or helping immune cells to overcome the molecular defenses of cancer cells. Notably, combinations of antibodies against CTLA-4 and PD-1 have shown impressive clinical responses in recent clinical trials.
Other checkpoint proteins, such as GITR and OX40, are receptors found on T cells that stimulate immune function.
Agenus and Ludwig are driving leading-edge programs to discover and develop fully human monoclonal antibodies that bind to key checkpoint proteins and activate or block their activities for use in cancer therapy.
About Ludwig Cancer Research
Ludwig Cancer Research is an international collaborative network of acclaimed scientists with a 40-year legacy of pioneering cancer discoveries. Ludwig combines basic research with the ability to translate its discoveries and conduct clinical trials to accelerate the development of new cancer diagnostics and therapies. Founded by American shipping magnate, Daniel K. Ludwig, Ludwig Cancer Research has invested $2.5 billion in research to date. Today, the scientific efforts endowed through his resources encompass the Ludwig Institute for Cancer Research and the Ludwig Centers at six U.S. institutions, all pursuing breakthroughs that will alter the course of cancer. For more information about Ludwig Cancer Research, visit www.ludwigcanceresearch.org. Follow Ludwig Cancer Research on Twitter at @Ludwig_Cancer.
About Agenus
Agenus is a biopharmaceutical company developing a portfolio of immuno-oncology candidates, including checkpoint modulators (CPMs), heat shock protein vaccines and adjuvants. The company’s proprietary discovery engine Retrocyte Display® is designed to rapidly generate high quality therapeutic antibody drug candidates using a high-throughput approach incorporating full-length IgG format human antibody libraries expressed in mammalian B-lineage cells. A portfolio of checkpoint modulator programs is advancing in preclinical development. The company’s heat shock protein vaccines for cancer and infectious disease are in Phase 2 studies. Agenus’ QS-21 Stimulon adjuvant platform is extensively partnered with GlaxoSmithKline and Janssen and includes several candidates in Phase 3 trials. Among Agenus and its partners, 23 programs are in clinical development. 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, including without limitation, statements regarding research and development program activities the ability of 4-Antibody platform to generate product candidates and their potential application in the prevention and treatment of diseases. 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended September 30, 2013 and in our periodic reports on Form 8K. 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. E. Breous-Nystrom et al., Methods 2014, http://dx.doi.org/10.1016/j.ymeth.2013.09.003
Yervoy is a registered trademark of Bristol-Myers Squibb. Retrocyte Display is a registered trademark of 4-Antibody AG.
CONTACT:
For Ludwig Cancer Research:
Rachel Steinhardt,
212-450-1582
Director of Communications
rsteinhardt@licr.org
or
For
Agenus Media and Investors:
Jonae R. Barnes, 617-818-2985
Vice
President
Investor Relations &
Corporate Communications
Jonae.Barnes@Agenusbio.com