Full Press Release Details
Agenus Reports Second Quarter 2024 Operational and Financial Results
LEXINGTON, Mass. (BUSINESS WIRE) Agenus Inc. ( Agenus ) (Nasdaq: AGEN), a leader in discovering
and developing novel immunological agents to treat various cancers, today provided a corporate update and reported financial results for the second quarter of 2024.
Agenus milestones this quarter include the release of interim data from our global randomized Phase 2 trial of BOT/BAL in relapsed/refractory MSS
colorectal cancer, consistent with our Phase 1 results, said Garo Armen, PhD, Chairman and CEO of Agenus. The robust responses in this trial and across various solid tumors validate BOT/BAL s potential to address challenging cancer
cases. Our data show significant and durable tumor reductions in patients who have exhausted other treatments. We are continuing to work with global health authorities and are dedicated to ensuring swift access to these life-saving therapies. We are
deeply moved by the strong support from the patient advocacy and clinical communities and remain committed to accelerating the BOT/BAL program and delivering innovative therapies to patients.
Partnerships and Financing
closed the first tranche of its $75 million royalty financing led by Ligand Pharmaceuticals, as announced in May. The company is continuing its efforts for a second closing of this financing. Additionally, Agenus is pursuing potential out-licensing transactions for several of its pipeline assets. This includes assets such as AGEN1777, previously licensed to Bristol Myers Squibb (BMS), and AGEN2373, for which Gilead s (GILD) option period has
expired. Agenus clinical and R&D teams are currently assessing the rich datasets generated in these programs.
To support our efforts to
deliver BOT/BAL to individuals living with colorectal cancer and other solid tumors, our strategic focus includes securing a global partnership for BOT/BAL. We are in discussions with several major biopharma companies that share our belief in the
therapeutic regimen s potential to provide meaningful clinical benefit to patients. The recent FDA interactions have provided additional clarity on the selection of dose and design of our phase 3 trial, which have been helpful in our
partnership discussions, said Robin Taylor, Agenus Chief Commercial Officer.
Agenus has also received recent interest in partnerships for its wholly owned Chemistry, Manufacturing, and
Controls (CMC) infrastructure in Northern California, including the newly launched 83,000 sq. ft. cGMP facility in Emeryville, California.
commitment to patient care, Agenus is launching a Named Patient Program for BOT/BAL. This program will provide a framework for physicians to prescribe this investigational combination to eligible patients before it becomes commercially available.
The program aims to offer early access to botensilimab for patients with critical needs, particularly those with colorectal cancer and other solid tumors that have not responded to standard treatments.
Patients can t wait, which is why Agenus is putting this Named Patient Program in place, a program that reflects our dedication to patients who
need promising new therapies, said Dr. Nils Eckardt, Global Head of Medical Affairs at Agenus. By providing this early access pathway, we re offering hope to patients with limited options while we continue to advance BOT/BAL
through clinical development. This program underscores our commitment to patients and our confidence in BOT/BAL s potential to transform cancer treatment.
Second Quarter 2024 Financial Overview
second quarter 2024 with a consolidated cash balance of $93.7 million compared to $76.1 million on December 31, 2023.
six months ended June 30, 2024, we recognized revenue, which includes non-cash revenue, of $23.5 million and $51.5 million respectively. This compares to $25.3 million and
$48.2 million, for the same periods in 2023. Our cash used in operations for the first half of 2024 was $76.4 million, reduced from $118.6 million for the first half of 2023. Our net loss for the three and six months ended
June 30, 2024, is $54.8 million and $118.3 million; these include non-cash operating expenses of $33.5 million and $71.8 million, respectively.
Financial Highlights
(in thousands, except per share data)
| June 30, 2024 | December 31, 2023 | |||||||||||||||
| Cash, cash equivalents and short-term investments | $ | 93,723 | $ | 76,110 | ||||||||||||
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues, non-cash royalty | $ | 22,582 | $ | 22,068 | $ | 50,349 | $ | 41,174 | ||||||||
| Revenues, research and development | 267 | 2,489 | 267 | 5,101 | ||||||||||||
| Revenues, other | 660 | 739 | 898 | 1,923 | ||||||||||||
| Total Revenue | 23,509 | 25,296 | 51,514 | 48,198 | ||||||||||||
| Research and development expenses | 36,771 | 59,285 | 80,696 | 116,402 | ||||||||||||
| General and administrative expenses | 16,816 | 20,415 | 33,672 | 38,653 | ||||||||||||
| Cost of service revenue | 115 | 254 | 222 | 2,548 | ||||||||||||
| Other income | (7,064 | ) | (883 | ) | (6,088 | ) | (1,604 | ) | ||||||||
| Non-cash interest expense | 31,668 | 19,647 | 61,263 | 36,920 | ||||||||||||
| Non-cash contingent consideration fair value adjustment | 8 | (398 | ) | |||||||||||||
| Net loss | $ | (54,797 | ) | $ | (73,430 | ) | $ | (118,251 | ) | $ | (144,323 | ) | ||||
| Net loss per share attributable to Agenus Inc. common stockholders: | $ | (2.52 | ) | $ | (3.93 | ) | $ | (5.56 | ) | $ | (8.22 | ) | ||||
| Cash used in operations | $ | 38,180 | $ | 43,453 | $ | 76,371 | $ | 118,569 | ||||||||
| Non-cash operating expenses | $ | 33,520 | $ | 28,947 | $ | 71,775 | $ | 53,882 |
Date: August 8th, 2024, 8:30 a.m. ET
To access dial-in numbers, please register here.
Conference ID: 73242
A live webcast and replay of the
conference call will be accessible on the company s website at https://investor.agenusbio.com/events-and-presentations.
Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to cold tumors which
generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune
responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with
Agenus investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials,
visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a
mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx).
Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical
operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
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 its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words may, believes, expects, anticipates,
hopes, intends, plans, forecasts, estimates, will, establish, potential, superiority, best in class, and similar expressions are
intended to identify forward-looking statements. 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 Annual Report on Form 10-K for 2023, and subsequent Quarterly Reports on Form 10-Q 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.