LEXINGTON, Mass., Aug. 3, 2017 /PRNewswire/ -- Agenus Inc.
(NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies and cancer vaccines, provided a
corporate update and reported financial results for the second quarter ended June 30, 2017.
"In the second quarter, we advanced our anti-CTLA-4 and anti-PD-1 antibodies in preparation for initiating combination trials
in the second half of this year. We also produced GMP grade product in our facilities in Berkeley and selected a commercial
supplier for our lead antibodies. In addition, our partnering efforts are maturing and we expect to close on several transactions
in the second half of this year," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "We are
committed to our path of generating potential first-in-class and best-in-class immuno-oncology agents, and doing so with speed,
quality and efficiency."
Anticipated Milestones for H2 2017:
- AGEN1884 (anti-CTLA-4) Phase 1 trial: complete dose-escalation and compile safety and pharmacodynamic data
- AGEN2034 (anti-PD-1) Phase 1/2 trial:
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- Complete dose-escalation for monotherapy, define optimal combination dose and collect safety and receptor occupancy
data
- Recruit patients with second line cervical cancer
- AGEN1884+AGEN2034 Phase 1b trial: commence combination trial
- AutoSynVax™ (neoantigen vaccine): immunological readouts expected in patients with advanced malignancies
- Advance our cell therapy spin off efforts
- Secure substantial funds from existing agreements and future transactions
Recent Highlights:
- AGEN1884 interim data presented at ASCO:
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- Safe at doses up to 3 mg/kg
- Partial response in a patient with angiosarcoma with 92% reduction in tumor burden at 0.1 mg/kg dose (since ASCO this
patient has experienced a complete response)
- QS-21 Stimulon® update:
-
- GSK's shingles vaccine containing Agenus' QS-21 Stimulon adjuvant showed strong immunogenicity in patients previously
treated with standard of care (Merck's Zostavax®)
- U.S. regulatory approval of Shingrix is anticipated in Q4
- Manufacturing readiness:
-
- Agenus West successful GMP production of AGEN2034 at 1,000L scale
- Selection of CMOs for production of commercial grade material for planned registrational trials
Second Quarter 2017 Financial Results
Cash, cash equivalents and short-term investments were $96.8 million at June 30, 2017 compared to $76.4 million as of December 31,
2016.
For the six months ended June 30, 2017, Agenus reported a net loss of $48.8 million, or $0.51 per share, compared with a net loss for the same period
in 2016 of $60.1 million or $0.69 per share. The decrease in
net loss for the six months ended June 30, 2017, compared to the net loss for the same period in
2016, was primarily due to the accelerated milestone payment received from Incyte during the first quarter of 2017. Our
operating expenses increased $9.2 million over the same period in 2016.
For the second quarter ended June 30, 2017, Agenus reported a net loss of $31.7 million, or $0.32 per share, compared with a net loss for the second
quarter of 2016 of $28.3 million, or $0.33 per share. The increase in
net loss for the three months ended June 30, 2017, compared to the net loss for the same period in
2016, was primarily due to the later stage advancement of our programs.
Conference Call, Webcast and Prepared Statement Information
Agenus executives will host a conference call on Thursday, August 3, 2017 at 11:00 a.m. Eastern Time. To access the live call, dial 1-844-492-3727 (U.S.) or 1-412-317-5118 (international)
and 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. 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 a number of combination approaches that leverage a broad repertoire of antibody therapeutics and proprietary cancer
vaccine platforms. 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; information
that may be important to investors will be routinely posted on our website.
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 Agenus' clinical trial plans and activities, anticipated milestones for the
second half of 2017, and the expected timing for FDA approval of GSK's Shingrix vaccine candidate containing Agenus' QS-21
Stimulon® adjuvant. 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.
Michael Plater
781-674-4504
michael.plater@agenusbio.com
Summary Consolidated Financial Information
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Condensed Consolidated Statements of Operations Data
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(in thousands, except per share data)
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(unaudited)
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Three months ended June 30,
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Six months ended June 30,
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2017
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2016
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2017
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2016
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Revenue
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$ 4,207
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$ 6,592
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$ 31,163
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$ 12,551
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Operating expenses:
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Research and development
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25,824
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22,362
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58,464
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47,400
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General and administrative
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8,136
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7,117
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15,906
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16,349
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Non-cash contingent consideration fair value adjustment
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(865)
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721
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(1,061)
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379
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Operating loss
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(28,888)
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(23,608)
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(42,146)
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(51,577)
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Other expense, net
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(2,825)
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(4,712)
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(6,670)
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(8,521)
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Net loss
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(31,713)
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(28,320)
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(48,816)
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(60,098)
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Dividends on Series A-1 convertible preferred stock
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(51)
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(51)
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(103)
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(102)
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Net loss attributable to common stockholders
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$ (31,764)
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$ (28,371)
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$ (48,919)
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$ (60,200)
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Per common share data, basic and diluted:
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Net loss attributable to common stockholders
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$ (0.32)
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$ (0.33)
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$ (0.51)
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$ (0.69)
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Weighted average number of common shares outstanding, basic and
diluted
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99,202
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86,965
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96,371
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86,826
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Condensed Consolidated Balance Sheet Data
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(in thousands)
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(unaudited)
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June 30, 2017
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December 31, 2016
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Cash, cash equivalents and short-term investments
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$ 96,766
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$ 76,437
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Total assets
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176,491
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156,986
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Total stockholders' deficit
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(17,481)
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(39,126)
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View original content with multimedia:http://www.prnewswire.com/news-releases/agenus-reports-second-quarter-2017-financial-results-and-provides-corporate-update-300498865.html
SOURCE Agenus Inc.