8-K
AGENUS INC (AGEN)
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
May 7, 2020
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<br><br><br>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))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br><br><br>Symbol(s) | Name of each exchange<br><br><br>on which registered |
|---|---|---|
| Common Stock, $0.01 par value per share | AGEN | The Nasdaq Capital Market |
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 ☐
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 7, 2020, Agenus Inc. announced its financial results for the quarter ended March 31, 2020. In connection with the announcement, the Company issued a press release and made a presentation during its earnings call, which are being furnished as Exhibits 99.1 and 99.2, respectively, to this current report on Form 8-K.
The information set forth under Item 2.02 and in Exhibits 99.1 and 99.2 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 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits are furnished herewith:
99.1 Press Release dated May 7, 2020
99.2 Earnings Presentation dated May 7, 2020
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.
| Date: May 7, 2020 | AGENUS INC. |
|---|---|
| By: /s/ Christine M. Klaskin | |
| Christine M. Klaskin | |
| VP, Finance |
Exhibit 99.1
Agenus First Quarter Results and Update
- AGEN1181 (nextgen CTLA-4) +/- balstilimab (anti-PD-1) shows benefit in 70% of patients in Phase 1
- Balstilimab + Zalifrelimab (anti-CTLA-4) achieve 26% response rates in a cohort of 55 patients with advanced cervical cancer
- Two INDs filed for AgenTus cell therapy (Allogeneic iNKTs) for cancer & COVID-19
- Two TIGIT antibodies advancing; IND filings starting in Q4
- Recent organizational streamlining expected to reduce annualized burn by $50M
LEXINGTON, Mass., May 7, 2020 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers provided a corporate update and reported financial results for the first quarter of 2020.
"We accelerated the development of AGEN1181, advanced our plans to file our BLAs and filed two INDs for our allogeneic iNKT cell therapy to treat cancer and COVID-19," said Garo Armen, Ph.D., Chairman and CEO, Agenus. "Our ability to rapidly enroll in our bali and zali trials, in just 2 years, underscores the speed with which we can advance our AGEN1181 +/- bali and our innovative pipeline of products including allogeneic cell therapy programs."
AGEN1181, reveals clinical benefit^1^ in >70% of response-evaluable patientsEarly data suggest that AGEN1181 could be a breakthrough in IO treatment:
- Confirmed CR with AGEN1181 (1 mg/kg) in advanced endometrial cancer with a poor prognosis
- Confirmed PR (significant tumor reduction) in advanced endometrial cancer with low-dose AGEN1181 + balstilimab
- Disease stabilization in the majority of response-evaluable patients
- Advisory board endorsed accelerated plans for AGEN1181 development
Balstilimab & zalifrelimab demonstrate ~26% response rates which are durable in an all-comer, non-biomarker selected population
- Large cohort analysis (n=55) bali + zali demonstrate ~26% response rates (4 CRs, 10 PRs) in refractory cervical cancer
- Responses are durable over 12 months
Allogeneic iNKTs advancing to clinic for the treatment of cancer and COVID-19
- COVID-19: iNKTs designed to eliminate COVID-19 virus, dampen harmful inflammation, and promote protection from reinfection (FIM 1H2020)
- CANCER: iNKTs designed to promote anti-tumor immunity in cancer & enable optimal combinations with Agenus checkpoint antibodies
Potential best and first in class TIGIT programs advancing to IND filing starting in 4Q2020
- Fc enhanced TIGIT antibody (AGEN1327) has outperformed all tested competitor antibodies with superior T cell activation in PD-1 or LAG-3 combos
- TIGIT bispecific (AGEN1777) demonstrated potent tumor killing in a difficult to treat colon cancer model where PD-1 antibodies alone are ineffective
Key Upcoming Milestones Expected
- BLA filings and pre-commercial activities
- IND filings for (2) TIGIT programs in 4Q2020 & 1H2021
- Ongoing read-outs from lead clinical trials (AGEN1181, Balstilimab, Zalifrelimab)
- Deliver new partnerships
- Reduce annualized burn by $50M to mitigate any pandemic related business risk
First Quarter Financial Results
We ended the first quarter of 2020 with a cash balance of $92.3 million as compared to $61.8 million at December 31, 2019.
For the first quarter ended March 31, 2020, we reported a cash burn from our operations of $32 million. Net loss for the quarter was $45 million or $0.31 per share which included non-cash expenses of $16 million. We generated net income for the same period in 2019 of $17 million or $0.14 per share. In the first quarter of 2019 we recognized revenue of $80 million which included revenue related to the upfront license fee from our transaction with Gilead in addition to non-cash royalties earned. For the same period in 2020 we recorded revenue of $15 million primarily related to non-cash royalties earned.
| Select Financial Information | ||
|---|---|---|
| (in thousands, except per share data) | ||
| (unaudited) | ||
| March 31, 2020 | December 31, 2019 | |
| Cash and cash equivalents | $ 92,284 | $ 61,808 |
| Three months ended March 31, | ||
| 2020 | 2019 | |
| Revenues, research and development | $ 1,928 | $ 70,871 |
| Revenues, non-cash royalty | 13,156 | 8,605 |
| Revenues, other | 44 | 415 |
| Total Revenue | 15,128 | 79,891 |
| Research and development expenses | 36,363 | 40,130 |
| General and administrative expenses | 10,613 | 10,805 |
| Other expense (income) | 1,243 | (655) |
| Non-cash interest expense | 13,844 | 9,428 |
| Loss on modification of debt | 2,720 | - |
| Non-cash contingent consideration fair value adjustment | (4,384) | 2,748 |
| Net (loss) income | $ (45,271) | $ 17,435 |
| Net (loss) income per share attributable to Agenus Inc. common stockholders: | ||
| Basic | $ (0.31) | $ 0.14 |
| Diluted | $ (0.31) | $ 0.12 |
| Cash (used in) provided by operations | $ (32,073) | $ 76,587 |
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 or with this link https://www.webcaster4.com/Webcast/Page/1556/34323.
A replay will be available on the Company's website approximately one hour after the call and will remain available until July 7, 2020. ****
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, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), 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 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.
Forward-Looking StatementsThis press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the anticipated regulatory and development timelines, as well as anticipated efficacy of Agenus' TIGIT programs, AGEN1181 and iNKT cell therapies, the expected reduction to annual cash burn and anticipated upcoming corporate milestones. 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 S. Buell, PhD
781-674-4420
Jennifer.Buell@agenusbio.com
^1^ Clinical benefit includes complete response, partial response, disease stabilization
agen-ex992_22.pptx.htm
May 2020 Exhibit 99.2
Forward-Looking Statements This presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Agenus and AgenTus' clinical development and regulatory plans and timelines, expected timing for clinical trials and releasing clinical data, anticipated milestones from partnership transactions, goals for 2020 and anticipated commercial market opportunities. 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 filed with the Securities and Exchange Commission and made available on our website at www.agenusbio.com. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this presentation. These statements speak only as of the date of this presentation, 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.
Key Achievements in Advancing Innovative I-O Therapies Delivered 14 INDs (2016 - Present) Produced 11 clinical batches GMP mAbs Positive clinical data released: 26% ORR in 2L cervical cancer (“Bali” + “Zali”) 14.3% ORR in 2L cervical cancer (“Bali” mono) Early responses in AGEN1181 Ph1 (CR, PR) Fully enrolled “Bali” +/- “Zali” cervical cancer Tracking for planned 2020 BLA filings Generated $540M (2014 - Present) Corporate collaborations Monetization of royalties Delivered on commitments to partners GSK, Merck, Incyte, Gilead
AGEN1181: Multifunctional anti-CTLA-4 Source: Agenus data Waight et al., Cancer Cell 2018 AGEN1181 is Fc enhanced To expand benefit to 3X more patients than first gen anti CTLA-4 To deliver superior performance alone and in combination with anti-PD-1 To improve safety
AGEN1181: Unprecedented Clinical Responses in Early Phase 1 Yervoy In >1000 patients with solid tumors outside of melanoma, only 4 CRs observed at high doses of 3 or 10mg/kg AGEN1181 >70% disease control rate among 22 patients treated with monotherapy or balstilimab combination 1 CR and 1 PR in aggressive cancer with poor prognosis (endometrial) at low dose levels (1mg/kg or lower) Responders had genetic polymorphism that AGEN1181 was designed to benefit Shows potential for AGEN1181 to benefit an additional 40% of patients unresponsive to Yervoy® due to genetics Source: Agenus data
Target Lesion 1 Target Lesion 2 AGEN1181 + Balstilimab (anti-PD-1): Endometrial Cancer Patient Shows Partial Response in Three Target Lesions and Complete Response in Non-Target Lesion Target Lesion 3 Non Target Lesion Baseline 12 weeks Source: Agenus data
Targeting cancer patients who have failed previous standard therapies for: US Population (2020E) Non-small cell lung cancer (NSCLC) ~31,000 Colorectal cancer ~6,000 Melanoma ~6,000 AGEN1181/Balstilimab Combination Has Blockbuster Revenue Potential Fast to market strategy via accelerated pathways in indications with large market and no active treatments Source: GlobalData
Agenus’ Balstilimab (anti-PD-1) +/- Zalifrelimab (anti-CTLA-4) References: 1 Bookman et al., Gynecol Oncol. 2000 Jun;77(3):446-9 2 Monk et al., J Clin Oncol. 2009 Mar 1;27(7):1069-74 3 Chung HC et al., J Clin Oncol. 2019 Jun 10;37(17):1470-1478 Chemotherapy Topotecan1 n=40 Roche Bevacizumab2 n=46 Merck Pembrolizumab3 n=77 (PD-L1 positive only) AGEN PD-1 Balstilimab n=42* AGEN PD-1 + CTLA-4 Bali/Zali n=55** Response rate 12.5% 10.9% 14.3% 14.3% ~26% Complete response 2.5% 0% 2.6% 2.4% 7.3% Partial response 10% 10.9% 11.7% 11.9% 18.2% Treatment related discontinuation (%) N/A 8.7% 4.1% 4.5% 7.8% Fast Track Designation received for Balstilimab +/- Zalifrelimab Potential Best-in-class treatment for second-line cervical cancer * Data from evaluable patients enrolled as of July 15, 2019 (updated interim analysis) ** Data from evaluable patients enrolled as of May 31, 2019 Evolution of cancer therapies ~2X more patients than previously reported ~2x more active than available treatments
Cytotoxicity GzmB/FasL IFNɣ iNKT cell Tumor cell Cytotoxicity NK or T cell IL-12 IFNɣ Activation iNKTs - Invariant Natural Killer T Cells Unmodified allogeneic cell therapy to treat solid tumors and COVID-19 AgenTus iNKTs: Require no genetic manipulation Have potential to treat both solid and liquid tumors Diminish the risk of graft vs. host disease (GvHD) Can be manufactured to treat large numbers of patients from a single batch Are synergistic with Agenus’ pipeline for combination treatment Can be available at substantially lower costs vs. today’s cell therapies IND Filed IL-12 Tumor associated macrophages
TIGIT: Highly Promising Novel Target for Immune Oncology What is TIGIT? (aka T cell immunoreceptor with Ig and ITIM domains) A critical regulator of innate and adaptive immune response A key synergistic mechanism to anti PD-1 therapy Hence, a natural partner for PD-1 combination therapy – particularly active in TIGIT-expressing tumors Agenus’ TIGIT programs have unique properties to optimize anti-tumor activity TIGIT Monospecific - AGEN1327: TIGIT antibody differentiated via “Fc enhanced” backbone for superior tumor killing as monotherapy or in combination with PD-1 TIGIT Bispecific - AGEN1777: TIGIT bispecific which also inhibits an undisclosed receptor expressed on T and NK cells
AGEN1327 (TIGIT monospecific) as Optimal PD-1 Partner AGEN1777 (TIGIT bispecific) for PD-1 Refractory Tumors IND H1 2021 Source: Agenus data in mouse models AGEN1777 shows effective tumor control in PD-1 refractory colon cancer model AGEN’s Fc-enhanced TIGIT monospecific offers superior tumor control IND YE 2020 Anti-PD-1 CR: 2/15 AGEN1777 TIGIT Bispecific Surrogate CR: 13/15 Control Competitor-like TIGIT mAb AGEN Fc enhanced TIGIT mAb
Key Achievements in Advancing Innovative I-O Therapies Delivered 14 INDs (2016 - Present) Produced 11 clinical batches GMP mAbs Positive clinical data released: 26% ORR in 2L cervical cancer (“Bali” + “Zali”) 14.3% ORR in 2L cervical cancer (“Bali” mono) Early responses in AGEN1181 Ph1 (CR, PR) Fully enrolled “Bali” +/- “Zali” cervical cancer Tracking for planned 2020 BLA filings Generated $540M (2014 - Present) Corporate collaborations Monetization of royalties Delivered on commitments to partners GSK, Merck, Incyte, Gilead
Agenus has Delivered More INDs in I-O vs. Big Pharma *Agenus analysis as of April 2020. Includes AgenTus’ AGENT-797 IND filing. I-O: Immuno-oncology
Agenus has Generated $540M from Recent Strategic and Financial Transactions $172.5M received1 $145M received2 $9M received $205M received More detailed information available in Agenus SEC and 10k filings 1 Including $30M in equity investment 2 Including $95M in equity investment $10M received
Agenus Owned Pipeline Highlights CTLA-4 Zalifrelimab AGEN1884 PD-1 Balstilimab AGEN2034 Product Mechanism/Target Preclinical Ph1 Ph2 Ph3 Filed Multipurpose 2nd Gen CTLA-4 AGEN1181 TIGIT AGEN1327 TIGIT AGEN1777 (Bispecific) CD137 AGEN2373 Regulatory T cell depletion AGENT-797 (Bispecific) Cancers COVID-19 (Unmodified iNKT Cell Therapy) AGENT-797 (Unmodified iNKT Cell Therapy) AGEN1223 OPTION OPTION Approved Notes: AGEN1884 and AGEN2034 are being evaluated in 2L cervical cancer and undisclosed tumors. | Recepta Biopharma S.A. has exclusive rights to AGEN1884 and AGEN2034 in Brazil and five other South American countries. *Gilead has an exclusive option to license AGEN2373 and AGEN1223. To view Agenus’ full pipeline, please visit https://agenusbio.com/pipeline/ Tumor Associated Macrophage AGEN1531 Anticipated BLA filing in combination with “Bali”: 2020 Anticipated BLA filing: 2020
TME conditioning anti-CD73/TGFb TRAP bifunctional fusion protein GS-1423 GITR INCAGN1876 OX40 INCAGN1949 TIM-3 INCAGN2390 LAG-3 INCAGN2385 Undisclosed MK-4830 ILT4 Agenus’ Partnered Pipeline Product Mechanism/Target Preclinical Ph1 Ph2 Ph3 Filed Approved Partner Shingles QS-21
What’s Next? 6 Clinical Data Readouts Zalifrelimab and Balstilimab Balstilimab AGEN1181 AGEN1223 AGEN2373 AgenT-797 2 BLA filings 2 INDs: TIGIT, TIGIT Bispecific Commercial Launch: Cervical More partnerships COVID-19: Protective (QS-21) Therapeutic (iNKT) approaches
