$200M received from BMS for anti-TIGIT bispecific antibody collaboration- FDA cleared IND for AGEN1777 clinical enrollment
- AGEN1181 rapidly advancing in the clinic; data to be presented in 2H 2021
- Cell therapy subsidiary MiNK Therapeutics filed confidential S-1 for planned IPO
- FDA accepted balstilimab BLA for Priority Review with December PDUFA date
“In the first half of this year, we announced a collaboration with BMS and advanced our flagship clinical candidate AGEN1181 to an important data inflection point,” said
AGEN1181 (Fc-enhanced anti-CTLA-4): Clinical data support superior activity in difficult-to-treat cancers
- Updated clinical data for AGEN1181 alone and in combination with balstilimab will be presented at an upcoming conference.
- Clinical responses seen in patients refractory to approved immunotherapies, including patients with microsatellite stable (MSS) tumors and melanoma, endometrial, and ovarian cancer with the low-affinity FcyRIIIA allele. No immune mediated hypophysitis, pneumonitis, or hepatitis (typically seen with first generation anti-CTLA-4s) were reported.
- Registrational trials targeted to commence by year-end 2021 with a focus on rapid path to Biologics License Application (BLA) submission.
MiNK Therapeutics: Allogeneic iNKT cell therapy company advances towards IPO
- MiNK Therapeutics (currently an
Agenus company) filed a confidential S-1 to support a planned Initial Public Offering (IPO). - Phase 1 trial of AGENT-797 in hematologic cancers dose cohorts completed with data readouts planned in the second half of 2021; Phase 1/2 expansion trials in viral acute respiratory distress syndrome (ARDS) are underway.
AGEN1777 (Fc-enhanced anti-TIGIT bispecific): Collaboration with BMS provides additional cash resources to advance Agenus’ high value drivers
- Global exclusive license with Bristol Myers Squibb for AGEN1777 provides
$200 million upfront cash. In addition,Agenus to receive up to$1.36 billion in development, regulatory, and commercial milestones, and tiered double-digit royalties upon product sales. - FDA cleared Investigational New Drug (IND) application; Phase 1 dosing with AGEN1777 alone and in combination with an anti-PD-1 in advanced solid tumors planned to begin this quarter.
Balstilimab (anti-PD-1): BLA accepted for Priority Review by
- Balstilimab BLA accepted for Priority Review by the
U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date ofDecember 16, 2021 . - Commercial preparation underway for a highly efficient, targeted launch to provide broad product access to physicians and patients while laying the foundation for future
Agenus products. - Clinical data presented at the
American Society of Clinical Oncology (ASCO) Annual Meeting:- Phase 2 data for balstilimab showed a response rate of 20% in PD-L1 positive tumors, overall response rate of 15%, and median duration of response of 15.4 months.
- Balstilimab showed superior tumor killing compared to approved anti-PD-1s such as pembrolizumab and nivolumab.
- Results from a Phase 2 trial of balstilimab plus zalifrelimab combination in recurrent or metastatic cervical cancer to be presented in a
Mini Oral Session at theEuropean Society for Medical Oncology (ESMO) Congress 2021 onSeptember 19 from 11:35 –11:40am ET .
Additional programs
- Phase 1 data for AGEN2373, a CD137 agonist antibody, in patients with advanced solid tumors were presented at ASCO 2021.
- No dose limiting toxicities were seen at doses up to 3 mg/kg, including no liver toxicity. Combination trials are in planning.
- No dose limiting toxicities were seen at doses up to 3 mg/kg, including no liver toxicity. Combination trials are in planning.
- Process for scale up of QS-21 manufacturing continues to advance.
- VISION platform knowledge base expanding to support AGEN1181 response prediction and combination discovery.
Management appointments
- Steven O’Day, MD appointed to Chief Medical Officer.
Andy Hurley appointed to Chief Commercial Officer.Marc Wiles , PhD appointed to Vice President of Regulatory Affairs.Julie DeSander promoted to Chief Business Officer.Joseph Grossman , MD, appointed to Vice President of Exploratory Medicine.Jason Paragas appointed to Vice President of Data Sciences.Jennifer Buell , PhD, appointed to Chief Executive Officer of MiNK Therapeutics.Dr. Buell will continue as a member of theAgenus Executive Committee.
Second Quarter Financial Results
We ended the second quarter of 2021 with a cash balance of
For the second quarter ended
Our cash used in operations for the six months ended
We recognized revenue of
Select Financial Information | ||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Cash and cash equivalents | $ | 73,543 | * | $ | 99,871 | |||||||||||
*Excludes | ||||||||||||||||
Three months ended | Six months ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Revenues, research and development | $ | 1,708 | $ | 18,068 | $ | 3,279 | $ | 19,996 | ||||||||
Revenues, non-cash royalty | 7,826 | 7,846 | 16,310 | 21,002 | ||||||||||||
Revenues, other | 1,196 | 1,031 | 2,860 | 1,075 | ||||||||||||
Total Revenue | 10,730 | 26,945 | 22,449 | 42,073 | ||||||||||||
Research and development expenses | 45,508 | 38,550 | 82,184 | 74,913 | ||||||||||||
General and administrative expenses | 16,650 | 14,195 | 33,003 | 24,809 | ||||||||||||
Cost of service revenue | 667 | 634 | 1,772 | 634 | ||||||||||||
Other expense (income) | 1,210 | 623 | (1,369 | ) | 1,865 | |||||||||||
Non-cash interest expense | 16,386 | 14,347 | 31,997 | 28,191 | ||||||||||||
Loss on modification of debt | - | - | - | 2,720 | ||||||||||||
Non-cash contingent consideration fair value adjustment | 14,300 | 6,840 | 13,256 | 2,456 | ||||||||||||
Net loss | $ | (83,991 | ) | $ | (48,244 | ) | $ | (138,394 | ) | $ | (93,515 | ) | ||||
Net loss per share attributable to | $ | (0.37 | ) | $ | (0.28 | ) | $ | (0.65 | ) | $ | (0.59 | ) | ||||
Cash used in operations | $ | (55,557 | ) | $ | (37,375 | ) | $ | (98,301 | ) | $ | (71,880 | ) | ||||
Non-cash operating expenses | $ | 30,171 | $ | 17,685 | $ | 41,984 | $ | 20,806 | ||||||||
Conference Call
Dial-in numbers: (833) 614-1394 (US) or (914) 987-7115 (International).
Conference ID number: 3686849.
Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at https://investor.agenusbio.com/events-and-presentations and via https://edge.media-server.com/mmc/p/gsbikqz2.
About
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding clinical development and regulatory plans and timelines, anticipated corporate milestones, new clinical data and program updates to be presented, and the anticipated commercial launch of balstilimab. 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
Contact
Agenus Investor Relations
781-674-4490
Jan.Medina@agenusbio.com
Agenus Media Relations
917-291-5744
kimberly.ha@kkhadvisors.com
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