Agenus Company Update and Second Quarter 2021 Financial Report

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  • $ 200 million received from BMS for anti-TIGIT bispecific antibody collaboration

  • FDA cleared IND for clinical recruitment AGEN1777

  • AGEN1181 is progressing rapidly in the clinic; data to be presented in 2H 2021

  • Cell Therapy Affiliate MiNK Therapeutics Filed Confidential S-1 File for Planned IPO

  • FDA accepted balstilimab BLA for priority review with PDUFA date of December

LEXINGTON, Mass., Aug. 09, 2021 (GLOBE NEWSWIRE) – Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a broad portfolio of checkpoint antibodies, cell therapies, adjuvants and vaccines designed to activate the immune response against cancers and infections, today provided a company update and released second quarter 2021 financial results.

“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 Garo Armen, PhD, president and CEO of Agenus. “In the second half of the year, we will release this data at a key cancer conference and be ready with our business platform for a balstilimab launch.”

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 a future conference.

  • Clinical responses observed in patients refractory to approved immunotherapies, including patients with stable microsatellite tumors (MSS) and melanoma, endometrial cancer and ovarian cancer with the low affinity allele FcyRIIIA. No immune-mediated hypophysitis, pneumonitis or hepatitis (usually seen with first generation anti-CTLA-4) have been reported.

  • Registration trials are expected to begin by the end of 2021 with a focus on the fast track to Biologics License Application (BLA) submission.

MiNK Therapeutics: allogeneic cell therapy company iNKT moves towards IPO

  • MiNK Therapeutics (currently an Agenus company) has filed a confidential S-1 to support a planned Initial Public Offering (IPO).

  • The phase 1 trial of AGENT-797 in hematologic cancer dose cohorts has been completed with data readings expected in the second half of 2021; Phase 1/2 extension 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 Engines

  • The exclusive worldwide license with Bristol Myers Squibb for AGEN1777 provides $ 200 million in initial cash. In addition, Agenus will receive up to $ 1.36 billion in development, regulatory and commercial milestones, as well as double-digit tiered royalties on product sales.

  • The FDA has cleared the Investigational New Drug Application (IND); Phase 1 dosing with AGEN1777 alone and in combination with anti-PD-1 in advanced solid tumors is expected to start this quarter.

Balstilimab (anti-PD-1): BLA accepted for priority review by US FDA; data updates presented to ASCO

  • Balstilimab BLA accepted for priority review by the United States Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2021.

  • Commercial preparation underway for a very efficient and targeted launch to provide wide access to products 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 20% response rate in PD-L1 positive tumors, an overall response rate of 15%, and a median duration of response of 15.4 months.

    • Balstilimab has shown superior tumor destruction compared to approved anti-PD-1s such as pembrolizumab and nivolumab.

  • The results of a phase 2 trial of the balstilimab and zalifrelimab combination in recurrent or metastatic cervical cancer will be presented during a mini oral session at the 2021 congress of the European Society for Medical Oncology (ESMO ) September 19 from 11:35 a.m. to 11:40 a.m. ET.

Additional programs

  • Phase 1 data from AGEN2373, a CD137 agonist antibody, in patients with advanced solid tumors was presented at ASCO 2021.

  • The process of scaling up the production of the QS-21 continues to progress.

  • The VISION platform knowledge base expands to support AGEN1181 response prediction and combination discovery.

Management meeting

  • Steven O’Day, MD appointed Chief Medical Officer.

  • Andy Hurley appointed Commercial Director.

  • Marc Wiles, PhD appointed Vice President of Regulatory Affairs.

  • Julie DeSander is promoted to Chief Business Officer.

  • Joseph Grossman, MD, appointed vice president of exploratory medicine.

  • Jason Paragas appointed vice president of data science.

  • Jennifer Buell, PhD, appointed CEO of MiNK Therapeutics. Dr Buell will continue as a member of the Agenus executive committee.

Second Quarter Financial Results

We ended the second quarter of 2021 with a cash balance of $ 74 million, compared to $ 100 million as at December 31, 2020. After the quarter ended, we received $ 200 million under our partnership with BMS.

For the second quarter ended June 30, 2021, our cash used in operations was $ 56 million and we recorded a net loss of $ 84 million or $ 0.37 per share, which included a number of non-cash items. This compares to cash used in operations for the same period in 2020 of $ 37 million and a net loss of $ 48 million or $ 0.28 per share. Non-cash operating expenses for the second quarter ended June 30, 2021 were $ 30 million compared to $ 18 million for the second quarter of 2020.

Our cash used for operations for the six-month period ended June 30, 2021 was $ 98 million with a net loss of $ 138 million or $ 0.65 per share compared to cash used for operations of $ 72 million. dollars and a net loss for the same period in 2020 of $ 94 million. or $ 0.59 per share.

We recognized revenues of $ 22 million and $ 42 million for the six months ended June 30, 2021 and 2020, respectively, which includes revenues related to non-monetary royalties earned, revenues recognized under our collaboration agreements and in 2020, $ 14 million from an initial license fee received.

Select financial information

(in thousands, except per share data)

(unaudited)

June 30, 2021

December 31, 2020

Cash and cash equivalents

$

73,543

*

$

99 871

*Excludes $ 200 million received in July 2021 from BMS

Three months ended June 30

Six months ended June 30

2021

2020

2021

2020

Turnover, research and development

$

1708

$

18,068

$

3 279

$

19,996

Income, non-monetary royalties

7,826

7 846

16 310

21,002

Income, other

1,196

1,031

2,860

1,075

Total income

10 730

26 945

22,449

42,073

Research and development costs

45,508

38,550

82 184

74 913

General and administrative expenses

16 650

14 195

33,003

24,809

Cost of service revenues

667

634

1,772

634

Other charges (income)

1 210

623

(1,369

)

1,865

Non-cash interest charges

16,386

14 347

31,997

28,191

Loss on debt modification

2,720

Fair value adjustment of non-cash contingent consideration

14,300

6,840

13,256

2 456

Net loss

$

(83,991

)

$

(48,244

)

$

(138,394

)

$

(93 515

)

Net loss per share attributable to common shareholders of Agenus Inc.

$

(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
Monday, August 9, 2021, 8:30 a.m. ET
Telephone numbers: (833) 614-1394 (United States) or (914) 987-7115 (International).
Conference ID: 3686849.

Webcast
A live webcast and replay of the conference call will be accessible from the Events and 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 Agenus
Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that mobilize the body’s immune system to fight cancer. The Company’s vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combined approaches that take advantage of a broad repertoire of therapeutic antibodies, adoptive cell therapies (via its subsidiary MiNK Therapeutics), d adjuvants and exclusive 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 account @agenus_bio. Information that may be important to investors will be posted regularly on our website and on Twitter.

Forward-looking statements
This press release contains forward-looking statements made in accordance with the safe harbor provisions of federal securities laws, including statements regarding clinical and regulatory development plans and schedules, anticipated company milestones, news clinical data and program updates to be presented, and anticipated commercial launches of balstilimab. These forward-looking statements are subject to risks and uncertainties which could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described in 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 significant reliance on any forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Agenus assumes no obligation to update or revise any statements, except to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Contact
Agenus Investor Relations
Jan Medina, CFA
Agenus
781-674-4490
[email protected]

Agenus Media Relations
Kimberly Ha
KKH Advisors
917-291-5744
[email protected]


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