Agenus Reports Third Quarter 2024 Financial Results and Strategic Advancements in BOT/BAL Development
Agenus (AGEN) reported Q3 2024 financial results and provided updates on BOT/BAL development. The company ended Q3 with $44.8 million in cash, down from $76.1 million in December 2023. Revenue was $25.1 million for Q3 2024, compared to $24.3 million in Q3 2023. Net loss was $67.2 million for Q3 2024. BOT/BAL showed promising clinical progress in MSS colorectal cancer and sarcomas. The company is pursuing strategic initiatives including asset monetization and operational efficiencies to strengthen its financial position. Cash used in operations decreased to $129.7 million for the first nine months of 2024, down from $183.8 million in the same period of 2023.
Agenus (AGEN) ha riportato i risultati finanziari del terzo trimestre del 2024 e fornito aggiornamenti sullo sviluppo di BOT/BAL. L'azienda ha chiuso il terzo trimestre con 44,8 milioni di dollari in contanti, in calo rispetto ai 76,1 milioni di dollari di dicembre 2023. I ricavi sono stati di 25,1 milioni di dollari per il terzo trimestre del 2024, rispetto ai 24,3 milioni di dollari del terzo trimestre del 2023. La perdita netta è stata di 67,2 milioni di dollari per il terzo trimestre del 2024. BOT/BAL ha mostrato progressi clinici promettenti nel cancro colorettale MSS e nei sarcomi. L'azienda sta perseguendo iniziative strategiche tra cui monetizzazione degli asset e miglioramenti operativi per rafforzare la sua posizione finanziaria. Il denaro utilizzato per le operazioni è diminuito a 129,7 milioni di dollari per i primi nove mesi del 2024, rispetto ai 183,8 milioni di dollari nello stesso periodo del 2023.
Agenus (AGEN) informó sobre los resultados financieros del tercer trimestre de 2024 y proporcionó actualizaciones sobre el desarrollo de BOT/BAL. La compañía cerró el tercer trimestre con 44.8 millones de dólares en efectivo, una disminución desde los 76.1 millones de dólares en diciembre de 2023. Los ingresos fueron de 25.1 millones de dólares para el tercer trimestre de 2024, en comparación con los 24.3 millones de dólares en el tercer trimestre de 2023. La pérdida neta fue de 67.2 millones de dólares para el tercer trimestre de 2024. BOT/BAL mostró un progreso clínico prometedor en el cáncer colorrectal MSS y en sarcomas. La empresa está persiguiendo iniciativas estratégicas que incluyen la monetización de activos y eficiencias operativas para fortalecer su posición financiera. El efectivo utilizado en operaciones disminuyó a 129.7 millones de dólares en los primeros nueve meses de 2024, en comparación con los 183.8 millones de dólares en el mismo período de 2023.
Agenus (AGEN)는 2024년 3분기 재무 결과를 보고하고 BOT/BAL 개발에 대한 업데이트를 제공했습니다. 회사는 2023년 12월 7610만 달러에서 감소하여 3분기 말에 4480만 달러의 현금을 보유했습니다. 2024년 3분기 매출은 2510만 달러로, 2023년 3분기 2430만 달러와 비교되었습니다. 2024년 3분기 순손실은 6720만 달러로 나타났습니다. BOT/BAL은 MSS 대장암과 육종에서 유망한 임상 진행을 보였습니다. 회사는 재무 상태를 강화하기 위해 자산 수익화 및 운영 효율성 향상을 포함한 전략적 이니셔티브를 추진하고 있습니다. 운영에 사용된 현금은 2024년 첫 아홉 달 동안 1억 2970만 달러로 감소했으며, 이는 2023년 같은 기간의 1억 8380만 달러에서 감소한 수치입니다.
Agenus (AGEN) a publié ses résultats financiers du troisième trimestre 2024 et a fourni des mises à jour sur le développement de BOT/BAL. La société a terminé le troisième trimestre avec 44,8 millions de dollars en liquidités, en baisse par rapport à 76,1 millions de dollars en décembre 2023. Le chiffre d'affaires s'élevait à 25,1 millions de dollars pour le troisième trimestre 2024, contre 24,3 millions de dollars pour le troisième trimestre 2023. La perte nette a atteint 67,2 millions de dollars pour le troisième trimestre 2024. BOT/BAL a montré des progrès cliniques prometteurs dans le cancer colorectal MSS et les sarcomes. L'entreprise poursuit des initiatives stratégiques, y compris la monétisation des actifs et l'efficacité opérationnelle, pour renforcer sa position financière. L'argent utilisé dans les opérations a diminué à 129,7 millions de dollars pour les neuf premiers mois de 2024, contre 183,8 millions de dollars sur la même période en 2023.
Agenus (AGEN) hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht und Updates zur Entwicklung von BOT/BAL bereitgestellt. Das Unternehmen schloss das dritte Quartal mit 44,8 Millionen Dollar in bar ab, verglichen mit 76,1 Millionen Dollar im Dezember 2023. Der Umsatz betrug 25,1 Millionen Dollar für das dritte Quartal 2024, im Vergleich zu 24,3 Millionen Dollar im dritten Quartal 2023. Der Nettoverlust betrug 67,2 Millionen Dollar für das dritte Quartal 2024. BOT/BAL zeigte vielversprechende klinische Fortschritte im MSS-Kolorektalkarzinom und bei Sarkomen. Das Unternehmen verfolgt strategische Initiativen, einschließlich der Monetarisierung von Vermögenswerten und der Effizienzsteigerung im Betrieb, um seine finanzielle Position zu stärken. Der in der Betriebstätigkeit verwendete Cashflow sank auf 129,7 Millionen Dollar in den ersten neun Monaten 2024, im Vergleich zu 183,8 Millionen Dollar im gleichen Zeitraum 2023.
- Revenue increased to $25.1M in Q3 2024 from $24.3M in Q3 2023
- Reduced cash burn with operations cash usage down to $129.7M from $183.8M YoY
- Positive clinical progress with BOT/BAL in MSS colorectal cancer trials
- EMA agreement reached on Phase 3 study design for BOT/BAL
- Cash position declined to $44.8M from $76.1M in December 2023
- Net loss of $67.2M in Q3 2024
- Additional share dilution through $7.1M stock sales after Q3
- Significant non-cash operating expenses of $40.5M in Q3 2024
Insights
The Q3 results reveal significant financial challenges with
Revenue growth remains modest at
The BOT/BAL combination demonstrates breakthrough potential in microsatellite stable (MSS) colorectal cancer, historically resistant to immunotherapy. The expansion into multiple investigator-sponsored trials (ISTs) and positive data in sarcomas indicate broad therapeutic potential. The EMA agreement on Phase 3 trial design represents significant regulatory progress.
However, the financial constraints could impact the development timeline and scope of clinical programs. The company's focus on compassionate use programs while beneficial for patients, may strain resources without immediate revenue generation. The success of upcoming data presentations in early 2025 will be important for attracting strategic partnerships or investment.
Transforming Cancer Treatment with BOT/BAL While Strengthening Financial Foundations
“BOT/BAL represents one of the most significant advancements in cancer immunotherapy, showing remarkable results in MSS colorectal cancer where previous treatments have fallen short,” said Garo Armen, Ph.D., Chairman and CEO of Agenus. “Its potential extends beyond this challenging cancer type, with promising efficacy seen in the neoadjuvant setting and other hard-to-treat cancers. While we are excited by these achievements, we remain mindful of the financial challenges that come with advancing such breakthrough therapies. We are focused on strategic initiatives, including asset monetization and operational efficiencies, to strengthen our financial position and continue driving forward. We are confident in our path and unwavering in our commitment to deliver innovative treatments that redefine patient care and create long-term value for our patients and shareholders.”
Key Highlights from Q3 2024
Breakthrough Clinical Progress - Botensilimab (BOT) and balstilimab (BAL) continues to deliver unprecedented outcomes across multiple cancer settings.
-
Neoadjuvant MSS Colorectal Cancer (CRC): BOT/BAL is advancing in 3 ISTs with consistent clinical activity in MSS CRC, a tumor historically resistant to immunotherapy. Initial results from Cornell study (ESMO GI 2024) show groundbreaking potential; results from additional trials in
Italy andthe Netherlands expected to be presented at prestigious oncology conferences in early 2025. - Broad and Durable Responses in Sarcoma and other cancers: Presentations at ESMO 2024 highlighted BOT/BAL’s clinical activity advanced sarcomas and other difficult-to-treat cancers, reinforcing its potential to redefine cancer treatment. Additional data updates are expected to be shared at key oncology conferences in the coming months.
Expanding Patient Access Globally - Agenus is committed to expanding patient access to BOT/BAL through Compassionate Use and Named Patient Programs, providing innovative treatment options for patients with limited alternatives. These programs empower physicians to deliver advanced care as regulatory frameworks evolve to support broader patient access.
Strategic Financial Initiatives - Agenus is actively pursuing a disciplined approach to strengthen its financial foundation:
- Operational Efficiencies: Cash outflows have been significantly reduced through focused measures.
-
Asset Monetization: Discussions to monetize real estate assets are progressing, reflecting increased interest and opportunities following the recent
U.S. elections, which have positively impacted financial markets. These monetization efforts are expected to provide near-term cash infusions to support operations. - Near-Term Transaction: Agenus is also advancing discussions on a strategic transaction designed to deliver substantial resources. The company views its current financial initiatives as a bridge to this transformative step, which is expected to position Agenus for long-term growth while maximizing value for shareholders.
Regulatory Alignment - Ongoing discussions with the European Medicines Agency (EMA) have progressed to agreement on dose selection and trial design for the pivotal Phase 3 study in MSS CRC, marking significant progress in BOT/BAL’s development. These achievements reflect a collaborative effort to enable access to this transformative combination to patients worldwide.
Q3 2024 Financial Summary
Agenus ended the third quarter 2024 with a consolidated cash balance of
For the three and nine months ended September 30, 2024, Agenus recognized revenue, which includes non-cash revenue, of
Financial Highlights |
||||||||||||||||
(in thousands, except per share data) |
||||||||||||||||
(unaudited) |
||||||||||||||||
September 30, 2024 |
December 31, 2023 |
|||||||||||||||
| Cash, cash equivalents and short-term investments | $ |
44,784 |
|
$ |
76,110 |
|
||||||||||
| Cash raised since quarter end | $ |
7,087 |
|
|||||||||||||
Three months ended September 30, |
Nine months ended September 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
| Revenue, including non-cash royalties |
|
25,112 |
|
|
24,314 |
|
|
76,626 |
|
|
72,513 |
|
||||
| Research and development expenses |
|
41,058 |
|
|
51,443 |
|
|
121,753 |
|
|
167,846 |
|
||||
| General and administrative expenses |
|
17,275 |
|
|
18,909 |
|
|
50,947 |
|
|
57,562 |
|
||||
| Cost of service revenue |
|
146 |
|
|
303 |
|
|
368 |
|
|
2,851 |
|
||||
| Other income |
|
(486 |
) |
|
(866 |
) |
|
(6,603 |
) |
|
(2,470 |
) |
||||
| Non-cash interest expense |
|
36,196 |
|
|
19,057 |
|
|
97,489 |
|
|
55,977 |
|
||||
| Non-cash fair value adjustment |
|
(1,863 |
) |
|
- |
|
|
(1,863 |
) |
|
(398 |
) |
||||
| Net loss | $ |
(67,214 |
) |
$ |
(64,532 |
) |
$ |
(185,465 |
) |
$ |
(208,855 |
) |
||||
| Net loss per share attributable to Agenus Inc. common stockholders | $ |
(3.08 |
) |
$ |
(3.29 |
) |
$ |
(8.65 |
) |
$ |
(11.43 |
) |
||||
| Cash used in operations | $ |
53,292 |
|
$ |
65,231 |
|
$ |
129,663 |
|
$ |
183,800 |
|
||||
| Non-cash operating expenses | $ |
40,529 |
|
$ |
28,122 |
|
$ |
112,304 |
|
$ |
82,004 |
|
||||
Conference Call
Date: Tuesday, November 12th, at 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 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
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.
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