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
March 12, 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 2.02Results of Operations and Financial Condition.
On March 12, 2020, Agenus Inc. announced its financial results for the quarter and year ended December 31, 2019. 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 9.01Financial Statements and Exhibits.
(d) Exhibits
The following exhibit is furnished herewith:
| 99.1 | Press Release dated March 12, 2020 |
|---|---|
| 99.2 | Earnings Presentation dated March 12, 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.
AGENUS INC.
| Date: March 12, 2020 | By: | /s/ Christine M. Klaskin |
|---|
Christine M. Klaskin
VP, Finance
Exhibit 99.1
Agenus Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update
AGEN1181 +/- balstilimab (anti-PD-1) reveals a complete response and new partial responses in phase 1 clinical trial
Balstilimab & zalifrelimab (anti-CTLA-4) demonstrate 26.5% response rates in an all-comer (non-biomarker selected) population with advanced cervical cancer
FDA grants Fast Track Designation for the investigation of combination balstilimab & zalifrelimab in relapsed/refractory metastatic cervical cancer
LEXINGTON, Mass., March 12, 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 fourth quarter and full year of 2019.
"We are excited by the clinical responses seen in our phase 1 trial of AGEN1181 alone and in combination with our PD-1," said Garo Armen, Ph.D., Chairman and CEO, Agenus. "2020 is a year of clinical data for us; with readouts from 6 separate programs. Additionally, the data we have generated from our cervical cancer combination trial may represent the most meaningful treatment option for these patients."
AGEN1181 Clinical Responses in a Phase 1 Trial
Early data suggest that AGEN1181 could be a breakthrough in IO treatment:
- Low-dose AGEN1181 (1 mg/kg) generated a complete response in advanced endometrial cancer with a poor prognosis (PD-L1[-], MSS, CD16a low affinity)
- Low-dose AGEN1181 + balstilimab delivered new partial responses
- Trial is in dose escalation and expansion to support rapid development
Updated data of balstilimab & zalifrelimab show 26.5% objective response rates which are durable in an all-comer, non-biomarker selected population of patients with refractory cervical cancer
- Balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) in second line cervical cancer demonstrate 26.5% response rates (4 CRs, 5 PRs, 8 SD), responses are durable (median not yet reached 6.9mos+) and may reveal best in class treatment option
- Combination receives FDA Fast Track designation for the investigation in relapsed/refractory metastatic cervical cancer
Key Milestones Expected in 2020
- 2 BLA filings for balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4)
- 3 INDs for new discoveries targeting myeloid & macrophage biology and allogeneic iNKT cell therapy
- 6 clinical data readouts
- Expect to trigger ~$60M in milestone payments for the year
- Additional partnerships and/or collaboration discussions underway
2019: A Year of Financial and Operational Achievements
- New business development transactions and milestone payments
generated $183 million
- $150M initially from our collaboration with Gilead ($120M in cash up front and $30M equity investment). Collected an additional $22.5M in cash milestones.
- $10 million upfront from a collaboration with Urogen. Potential for ~$200M in future milestones
- Completed accrual and pre-planned interim analysis of two pivotal trials to support the planned BLA filing of balstilimab and zalifrelimab in second-line cervical cancer
- Launched 4 clinical programs with our first-in-class/best-in-class discoveries, including AGEN1181, AGEN1223, AGEN2373, and GS-1423 (licensed to GILD)
- Advanced allogeneic cell therapy program for planned IND filing
Fourth Quarter and Full Year 2019 Financial Results
We ended 2019 with a cash balance of $62 million as compared to $53 million at December 31, 2018. Based on our year end cash balance and cash receipts in our current quarter, we expect our cash balance to be in excess of $100M at the end of the first quarter of 2020.
Cash used in operations for the quarter ended December 2019 was $32 million compared to $36 million for the same period in 2018. Cash used in operations for the year ended December 2019 was $19 million as compared to cash used in operations of $131 million for the same period in 2018.
For the fourth quarter ended December 31, 2019, we reported net loss of $31 million or $0.22 per share compared to a net loss for same period in 2018 of $49 million, or $0.40 per share. For the year ended December 31, 2019, we reported a net loss of $112 million or $0.80 per share compared to a net loss for the same period in 2018 of $162 million or $1.44 per share.
During the year ended December 2019 we recognized revenue of $150 million which includes revenue from our transaction with Gilead, non-cash royalties earned and a royalty sales milestone. This compares to revenue of $37 million for the year ended December 2018. For the year ended 2019 we also recorded $42 million of non-cash interest expense due to our transaction with HCR related to the sale of future royalties.
| Select Financial Information | |||
|---|---|---|---|
| (in thousands, except per share data) | |||
| (unaudited) | |||
| December 31, 2019 | December 31, 2018 | ||
| Cash and cash equivalents | $ 61,808 | 53,054 | |
| Three months ended December 31, | Year ended December 31, | ||
| 2019 | 2018 | 2019 | |
| Revenues, research and development | $ 18,824 | $ 1,090 | 99,845 |
| Revenues, non-cash<br>royalty | 352 | 5,361 | 30,424 |
| Revenues, royalty sales milestone | 15,100 | - | 15,100 |
| Revenues, other | 226 | - | 4,679 |
| Total Revenue | 34,502 | 6,451 | 150,048 |
| Research and development expenses | 36,834 | 36,031 | 168,339 |
| General and administrative expenses | 12,319 | 9,724 | 46,041 |
| Other expense (income) | (209) | 887 | (778) |
| Non-cash interest expense | 11,784 | 8,536 | 42,201 |
| Loss on early extinguishment of debt | - | - | - |
| Non-cash contingent consideration fair value<br>adjustment | 4,625 | 121 | 5,805 |
| Net loss | (30,851) | (48,848) | (111,560) |
| Net loss per share attributable to Agenus Inc. common<br>stockholders | $ (0.22) | $ (0.40) | (0.80) |
| Cash (used in) provided by operations | $ (31,780) | $ (35,812) | (18,682) |
All values are in US Dollars.
Conference Call, Webcast and Prepared Statement Information
Date: Thursday, March 12, 2020
Time: 8:30 a.m. ET
Domestic Dial-in Number: 1-844-492-3727 (U.S.)
International Dial-in Number: 1-412-317-5118 (International)
Conference ID: Agenus
The call will also be webcast and will be accessible from the Company's website at http://investor.agenusbio.com/presentation-webcasts or via the link: https://www.webcaster4.com/Webcast/Page/1556/33333.
A replay will be available on the Company's website approximately two hours after the call.
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 Agenus' anticipated BLA filings and the anticipated benefits of Fast Track designation. 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.
Regina Grebla, PhD
781-674-4495
Regina.Grebla@agenusbio.com
agen-ex992_6.pptx.htm
Exhibit 99.2 Earnings Call: 4Q and Full Year 2019 Earnings March 12, 2020
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, expected clinical results and therapeutic benefit, anticipated milestones from partnership transactions, and goals for 2020. 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. Forward-Looking Statements
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. Mechanism/Target Product Partner Preclinical Phase 1 Phase 2 Phase 3 Filed Approved CTLA-4 Zalifrelimab (AGEN 1884) PD-1 Balstilimab (AGEN 2034) Next-generation CTLA-4 AGEN1181 NK cell (bispecific) AGEN1777 Tumor-associated macrophage AGEN1531 TIGIT Cytokine (bispecific) TME conditioning (bispecific) Stromal conditioning (bispecific) Glioblastoma (newly diagnosed) ProphageTM Personalized Neoantigen Vaccine AutoSynVaxTM Off-the-Shelf Neoantigen Vaccine PhosphoSynVaxTM Allogeneic Cell Therapy Undisclosed Target Allogeneic Cell Therapy Undisclosed Target Allogeneic Cell Therapy Undisclosed Target Allogeneic Cell Therapy Undisclosed Target Allogeneic Cell Therapy Undisclosed Target CD137 AGEN2373* Regulatory T cell depletion (bispecific) AGEN1223* TME conditioning anti-CD73/TGFb TRAP bifunctional fusion protein GS-1423 GITR INCAGN1876 OX40 INCAGN1949 TIM-3 INCAGN2390 LAG-3 INCAGN2385 Undisclosed ILT4 MK-4830 Shingles QS-21 Stimulon® Malaria Fully-owned Pipeline Partnered Pipeline Agenus Pipeline
Balstilimab + Zalifrelimab ORR Increased from ~21% to ~27% with Data Maturity in 2L Cervical Cancer Early Analysis (N=34) 4.7 mo. Median F/U Mature Analysis (N=34) 12.2 mo. Median F/U Confirmed Overall Response Rate (ORR %) [95% CI] 20.6 [8.7, 37.9] 26.5 [14.6, 43.1] Complete Response (%) Partial Response (%) Stable Disease (%) 8.8 11.8 29.4 11.8 14.7 23.5 Median Duration of Response (Months) Not reached (5.5+mos) Not reached (6.9+mos)
CTLA-4 Improves PD-1 Responses & Durability in Multiple Tumors 2-3x improved ORR with CTLA4 in certain tumors PD-1 ORR PD-1/CTLA-4 ORR
Agenus Notable Strategic Partnerships ~$2.5B in potential milestones & royalties; $540M1 already received $172.5M received2 $145M received3 $9M received $205M received1 More detailed information available in Agenus SEC and 10k filings 1 Includes $2.4M that has been earned but not received as of March 12, 2020 2 Including $30M in equity investment 3Including $95M in equity investment 4Eligible for a $25M milestone based on Shingrix meeting a commercial sales targets metric by 2026 $10M received Eligible $200M milestones Royalties Eligible $85M milestones Royalties Eligible $25M milestones4 Eligible $1.7Bn milestones Royalties Eligible $450M milestones Royalties Anticipate ~$60M milestones from existing partnerships during 2020
