Agenus Reports Second Quarter 2024 Operational and Financial Results

Rhea-AI Summary

Agenus Inc. (Nasdaq: AGEN) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

1. Robust Phase 2 data for BOT/BAL in metastatic MSS CRC, showing a 19.4% ORR and 90% 6-month OS rate.

2. Promising results in neoadjuvant CRC with 78% of patients achieving ≥50% tumor reduction.

3. Initiation of global regulatory engagements for BOT/BAL approval pathways.

4. Q2 2024 revenue of $23.5 million and a net loss of $54.8 million.

5. Cash balance of $93.7 million as of June 30, 2024.

Agenus is pursuing partnerships and financing options to support its BOT/BAL program and other pipeline assets.

Positive

• Robust Phase 2 data for BOT/BAL in metastatic MSS CRC with 19.4% ORR and 90% 6-month OS rate
• 78% of neoadjuvant CRC patients achieved ≥50% tumor reduction in NEST-2 cohort
• Initiation of global regulatory engagements for BOT/BAL approval pathways
• Reduced cash used in operations from $118.6 million in H1 2023 to $76.4 million in H1 2024
• Closed first tranche of $75 million royalty financing led by Ligand Pharmaceuticals

Negative

• Net loss of $54.8 million for Q2 2024
• FDA discouraged submission of interim results for Accelerated Approval based on current dataset
• Decline in research and development revenues from $2.49 million in Q2 2023 to $267,000 in Q2 2024

Financial Analyst

Agenus' Q2 2024 results show mixed financial performance. Revenue of $23.5 million for Q2 is slightly down from $25.3 million in Q2 2023. However, H1 2024 revenue of $51.5 million is up from $48.2 million in H1 2023. The company's cash position improved to $93.7 million, up from $76.1 million at the end of 2023.

Notably, cash burn has decreased significantly, with cash used in operations for H1 2024 at $76.4 million, down from $118.6 million in H1 2023. This 35.6% reduction in cash burn is a positive sign for the company's financial health. However, Agenus still reported a net loss of $54.8 million for Q2 and $118.3 million for H1 2024, indicating ongoing financial challenges.

The company's focus on potential partnerships and out-licensing opportunities could provide additional revenue streams and support its financial position. The $75 million royalty financing with Ligand Pharmaceuticals is a positive step, but investors should monitor the progress of the second tranche closing.

Oncology Expert

The clinical data for Agenus' BOT/BAL combination therapy is showing promising results across multiple cancer types. The 19.4% confirmed overall response rate and 90% 6-month overall survival rate in relapsed/refractory MSS colorectal cancer (CRC) are particularly noteworthy, given the historically poor response of this cancer type to immunotherapies.

The NEST study results in neoadjuvant CRC are even more impressive, with 78% of MSS CRC patients achieving at least 50% tumor reduction and 56% achieving complete pathologic responses. These results are unprecedented in MSS CRC and could potentially change the treatment landscape if confirmed in larger studies.

The broad activity across 10 different cancer types and various disease stages, including challenging metastatic sites, suggests that BOT/BAL could have wide-ranging applications in oncology. However, it's important to see more mature data and results from the planned Phase 3 trial to fully assess the therapy's potential impact on patient outcomes and standard of care.

Regulatory Affairs Specialist

Agenus' regulatory strategy for BOT/BAL is progressing, albeit with some challenges. The company has initiated engagement with the European Medicines Authority (EMA) and plans to explore registration paths in other key markets. This global approach could potentially expedite market access if the therapy proves successful.

However, the FDA's discouragement of submitting interim results for Accelerated Approval is a setback. Agenus plans to re-engage with more mature data, but this could delay the potential approval timeline in the US. The alignment with FDA on the Phase 3 study design is positive, as it reduces regulatory risk for this critical trial.

The launch of a Named Patient Program is a strategic move that could provide early access to the therapy and generate additional real-world data. This program, along with the NCI collaboration, demonstrates Agenus' commitment to advancing BOT/BAL and could support future regulatory submissions.

Investors should closely monitor upcoming regulatory interactions, particularly with the FDA, as they will be important in determining the timeline for potential market entry.

• Robust Phase 2 Data Validate Consistent Clinical Activity of BOT/BAL in Metastatic MSS CRC
• Maturing Data Across BOT/BAL Program Demonstrate Broad Solid Tumor Activity in the Late Stage, First-Line with Chemo Combinations, and Neoadjuvant disease
• Commenced Interactions with Global Regulatory Authorities for BOT/BAL Approval Pathways
• Data from ESMO GI Demonstrate Pathologic Complete Responses with BOT/BAL Therapy in Neoadjuvant CRC Patients

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.”

Key Highlights:

• Maturing Data Demonstrate Activity in Multiple Cancers and Stages of Disease: Data from our BOT/BAL clinical program in ~1,100 patients have demonstrated robust activity across 10 different cancers and across early and late-stage disease, including refractory metastatic and neoadjuvant settings. This includes durable tumor reductions and, in some cases, complete responses in patients who have failed approved therapies. Some of these data have already been presented and published, with new data to be presented at upcoming conferences and published in top tier scientific publications.
• Promising Interim Data: Topline interim data from the randomized Phase 2 trial in r/r MSS CRC show trends consistent with the more mature data from the Phase 1 study at a similar follow up timepoint. This includes a now RECIST confirmed overall response rate (ORR) of 19.4% and a 6-month overall survival (OS) rate of 90% in the selected BOT 75mg/BAL combination cohort. BOT/BAL’s safety profile continues to be manageable, with no new signals observed.
• Nature Medicine and Cancer Discovery Publications: Recent publications in Nature Medicine and Cancer Discovery highlighted the promising results of the BOT/BAL combination in metastatic MSS CRC, the most prevalent form of CRC, affecting 95% of metastatic CRC patients.
• NEST Study Results: Updated results from the NEST study in neoadjuvant CRC presented at ESMO GI in June demonstrated unprecedented activity of BOT/BAL in MSS CRC that has historically been poorly responsive to IO therapies. In the NEST-2 cohort of extended treatment (8 weeks), 78% (7/9) of MSS CRC patients achieved pathologic responses of at least 50% tumor reduction, with 56% (5/9) achieving complete pathologic responses (cPR). Toxicities were well managed, and no surgeries were delayed due to adverse events.
• ASCO Annual Meeting: New analyses presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June highlighted BOT/BAL activity in metastatic CRC across challenging sites of metastatic disease, including peritoneal metastases, soft tissue, bone, and brain. The ORR was consistent across favorable and unfavorable sites of disease and ranged from 18-33%, with disease control rates (DCR) ranging from 67-82%. Median OS remained consistent and ranged from 20.7 months to not reached.
• National Cancer Institute Collaboration: The National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP) began accepting Letters of Intent to conduct clinical studies using BOT during Q2. CTEP is also considering requests to supply BOT for nonclinical studies.
• Global Regulatory Engagements: Agenus initiated engagement with the European Medicines Authority (EMA) and has subsequent meetings planned for this fall. In addition, Agenus will explore registration paths for BOT/BAL in r/r MSS CRC with regulatory authorities in other geographies, including the UK, Canada, Australia, Israel, and Brazil.
• Upcoming Data: Agenus anticipates releasing further data later this year across the BOT/BAL program beyond MSS CRC that will continue to demonstrate the uniquely differentiated clinical activity of this combination therapy.
• Phase 3 Study in r/r MSS CRC: Agenus has gained alignment with the FDA on the proposed design and dosing regimen for its upcoming Phase 3 study in the r/r MSS CRC treatment setting and intends to initiate this study soon.
• FDA Interaction: While the FDA discouraged the submission of interim results for Accelerated Approval based on the dataset shared with them during the July End-of-Phase 2 meeting, Agenus plans to further engage the FDA with more mature data to support its AA strategy.

Partnerships and Financing

Agenus 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.

As part of its 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

We ended the second quarter 2024 with a consolidated cash balance of $93.7 million compared to $76.1 million on December 31, 2023.

For the three and 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)
(unaudited)
					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

Conference Call

Date: August 8th, 2024, 8:30 a.m. ET
To access dial-in numbers, please register here.
Conference ID: 73242

Webcast

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.

About Botensilimab

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.

About Agenus

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.

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Source: Agenus Inc.

FAQ

What were Agenus' (AGEN) key financial results for Q2 2024?

Agenus (AGEN) reported Q2 2024 revenue of $23.5 million, a net loss of $54.8 million, and ended the quarter with a cash balance of $93.7 million.

What were the Phase 2 results for BOT/BAL in metastatic MSS CRC?

The Phase 2 trial of BOT/BAL in metastatic MSS CRC showed a confirmed overall response rate (ORR) of 19.4% and a 6-month overall survival (OS) rate of 90% in the selected BOT 75mg/BAL combination cohort.

How did Agenus' (AGEN) cash used in operations change in H1 2024 compared to H1 2023?

Agenus' (AGEN) cash used in operations decreased from $118.6 million in H1 2023 to $76.4 million in H1 2024, showing improved operational efficiency.

What were the results of the NEST-2 study for BOT/BAL in neoadjuvant CRC?

In the NEST-2 cohort, 78% (7/9) of MSS CRC patients achieved pathologic responses of at least 50% tumor reduction, with 56% (5/9) achieving complete pathologic responses (cPR) after 8 weeks of BOT/BAL treatment.