AGENUS INC (AGEN)·Q1 2024 Earnings Summary

Executive Summary

• Agenus reported Q1 2024 revenue of $28.0M and a net loss of $63.5M (-$3.04 per share), with cash used in operations of $38.2M and cash/cash equivalents of $52.9M; the quarter included announcement of a $100M royalty financing from Ligand to support BOT/BAL development and launch readiness .
• Clinical momentum in r/r MSS CRC (non-active liver metastases) remained strong: confirmed ORR 23% (n=77), median OS 21.2 months, 12‑month OS 71%, 18‑month OS 62%, with grade ≥3 diarrhea/colitis ~16% .
• Management plans an FDA meeting in July 2024 to align on an accelerated approval BLA for BOT/BAL in r/r MSS CRC NLM and to commence the confirmatory Phase III trial this year; commercial readiness (CMC supply, leadership hires) is underway .
• Prior quarter (Q4 2023) delivered $84.0M revenue and a net loss of $49.0M (-$0.13 per share) as the company secured Fast Track for BOT/BAL in MSS CRC NLM and guided to being funded through 2024; Q3 2023 revenue was $24.3M with a net loss of $64.5M .
• Notable stock catalysts: finalized Ligand royalty financing, FDA July meeting outcome, Phase II CRC data disclosure in 2H 2024, and initiation of confirmatory Phase III; reverse split achieved Russell eligibility and restored Nasdaq compliance, broadening investor access .

What Went Well and What Went Wrong

• What Went Well

  • Secured minimally dilutive $100M royalty financing (initial $75M, optional $25M) from Ligand to fund BOT/BAL development and launch readiness. “This capital infusion is pivotal for advancing the development and market readiness of our BOT/BAL treatment.” – CEO Garo Armen .
  • Robust efficacy signals in r/r MSS CRC NLM: 23% confirmed ORR (n=77), mOS 21.2 months, 12‑mo OS 71%, 18‑mo OS 62%; safety manageable with ~16% grade ≥3 diarrhea/colitis .
  • Commercial buildout: seasoned leadership across sales, marketing, access, and operations; dual CMO/wholly owned GMP facility readiness; strong market research (~150 U.S. GI oncologists) indicating significant anticipation for BOT/BAL .

• What Went Wrong

  • Ongoing operating losses and high cash burn: Q1 2024 net loss $63.5M (-$3.04/share) with cash from operations of -$38.2M, increasing capital dependency despite reductions vs Q4 .
  • Limited disclosure on Phase II CRC topline prior to FDA meeting; analysts flagged desire for more detail, but management held data to preserve regulatory process timing .
  • Adverse events remain a watch item: immune‑related diarrhea/colitis at grade ≥3 levels in ~16% of CRC patients; increases vs ~14% reported previously, though managed per standard therapies .

Financial Results

Clinical KPIs – MSS CRC (non-active liver metastases cohort):

Neoadjuvant CRC (NEST-1, window-of-opportunity):

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “This capital infusion is pivotal for advancing the development and market readiness of our BOT/BAL treatment… we plan to engage with the FDA in the second half of 2024 [and] commence the submission of a Biologics License Application under the accelerated approval provision…” – Garo Armen, CEO .
• “It is clear to us that there is significant anticipation for BOT/BAL… underscores the urgency we feel to deliver this important treatment option to patients.” – Robin Taylor, CCO .
• “For the first quarter ended March 31, 2024, we recognized revenue of $28 million and incurred a net loss of $63.5 million… Our cash used in operations… was $38 million… cash and cash equivalent balance of $52.9 million.” – Christine Klaskin, VP Finance .
• “We plan to gain alignment with the FDA… in an upcoming meeting anticipated in July 2024… Phase III trial will commence this year and enroll in time to support an accelerated approval.” – Steven O’Day, CMO .

Q&A Highlights

• Accelerated approval evidence base: Management confident in efficacy/safety across Phase I/II cohorts at active doses; detailed counts held until FDA engagement to protect process integrity .
• Phase II CRC data: Comparable to Phase I at similar follow‑up; topline to be shared post‑FDA meeting; follow‑up maturation considered in regulatory planning .
• Confirmatory Phase III design/timing: Target same line of therapy; commence in 2024 to enroll ahead of potential accelerated approval; first‑line confirmatory possible depending on FDA guidance .
• IST pipeline: >50 IST requests across CRC (early lines), melanoma, lung, sarcoma; prioritization to avoid data cleaning bottlenecks ahead of BLA .
• Financing details: Ligand has option for additional $25M at its discretion; transaction expected to close in May; share count just over 20M post reverse split .

Estimates Context

Values retrieved from S&P Global were unavailable due to system limits; consensus comparisons could not be performed at this time.*

Implications: Without consensus anchors, sell‑side models will likely recalibrate around liquidity improvements (Ligand financing), regulatory timing (July FDA meeting), and commercialization readiness; near‑term narrative driven more by regulatory outcomes than P&L beat/miss dynamics .

Key Takeaways for Investors

• Regulatory inflection approaching: FDA July meeting for BOT/BAL in r/r MSS CRC NLM; expect BLA submission to begin in 2H 2024 and Phase III initiation this year – key binary catalyst path .
• Liquidity strengthened without equity dilution: $100M Ligand royalty financing (with potential expansion to $200M) materially improves funding runway for development and launch readiness .
• Clinical risk/reward: Durable responses and survival signals in CRC cohorts versus historical SOC benchmarks; watch GI immune‑related AEs (~16% grade ≥3) and liver metastasis exclusion in lead indication .
• Commercial execution: Experienced leadership, supply readiness (CMOs and Emeryville GMP facility), and strong KOL/oncologist interest underpin potential launch momentum pending approval .
• Capital markets positioning: 20:1 reverse split restored Nasdaq compliance and supports Russell inclusion/institutional access—potentially expanding shareholder base .
• Pipeline breadth: Data updates in melanoma, lung, sarcoma, pancreatic expected 2H 2024; ISTs may enable targeted, biomarker‑guided expansions with potentially rapid paths in select indications .
• Trading setup: Near‑term stock moves likely keyed to financing closure, FDA meeting minutes, and Phase II CRC disclosure; medium‑term thesis hinges on accelerated approval prospects and Phase III execution .