HOOKIPA Pharma Inc. (HOOK)·Q2 2024 Earnings Summary

Executive Summary

• Q2 2024 revenue was $1.29M with a net loss of $19.10M (EPS $(1.52)), reflecting the wind-down of Roche collaboration revenue recognition; cash and equivalents were $77.35M as of June 30, 2024 .
• Pipeline momentum remained the core narrative: best‑in‑class HB‑200 Phase 2 data presented at ASCO, FDA alignment on the pivotal AVALON‑1 Phase 2/3 design (first‑line HPV16+ OPSCC), and EMA PRIME designation; management reaffirmed AVALON‑1 start in Q4 2024 .
• Corporate actions and funding: $10M Roche milestone (April) and, post‑quarter, a $5M Gilead milestone (July) tied to HB‑500 first dosing; HOOK enacted a 1‑for‑10 reverse split to regain Nasdaq minimum bid-price compliance and appointed a new CEO and CFO in July .
• No quantitative guidance was issued; Street consensus from S&P Global for Q2 2024 was unavailable at query time, so we cannot assess beats/misses vs estimates. Management emphasized clinical execution and capital planning as near‑term stock catalysts (AVALON‑1 initiation, additional HB‑200 data flow) .

What Went Well and What Went Wrong

What Went Well

• HB‑200 clinical data strengthened the thesis: in CPS ≥20 first‑line patients, HB‑200 + pembrolizumab showed 53% confirmed ORR, 18% CR, 82% DCR, preliminary PFS 16.3 months, and 9‑month OS 88%, favorable to historical pembrolizumab monotherapy benchmarks; management calls the profile “best‑in‑class” among HPV16‑targeted therapeutics .
• Regulatory and pivotal readiness: FDA alignment on the seamless, adaptive AVALON‑1 Phase 2/3 with a path to potential accelerated approval; EMA PRIME designation supports an expedited EU path; first patient remains on track for Q4 2024 .
• Non‑dilutive cash inflows and partnership execution: $10M Roche success milestone in April (HB‑700 IND) and $5M Gilead milestone in July (HB‑500 first person dosed), enhancing funding flexibility for clinical execution .

Quote: “Our best‑in‑class Phase 2 data … has generated significant momentum … preparations are well underway for our AVALON‑1 pivotal adaptive Phase 2/3 trial … expected to be initiated in the fourth quarter of this year.” — CEO Malte Peters .
Quote: “We are keenly focused on clinical execution and operational excellence … to ensure that we are sufficiently capitalized to reach these goals.” — CFO Terry Coelho .

What Went Wrong

• Revenue normalization post‑Roche termination created a sharp QoQ step‑down (from $36.60M in Q1 to $1.29M in Q2), driving a return to GAAP net loss (from $14.38M profit in Q1 to $(19.10)M loss in Q2) .
• Cash burn continued: cash fell to $77.35M at quarter‑end from $92.96M at March 31 and $117.52M at year‑end 2023; management completed a restructuring plan by June 30 to refocus spending, but clinical scale‑up remains capital intensive .
• No numeric financial guidance or revenue visibility, as revenue depends on collaboration accounting and milestones; lack of consensus data limits external benchmarking and may contribute to modeling uncertainty near term .

Financial Results

Notes:

• Q1 revenue and profitability were primarily driven by accelerated recognition of previously deferred Roche collaboration consideration due to termination; Q2 normalized materially lower following that event .
• Restructuring expense was $0.054M in Q2 (plan completed by June 30) .

KPIs (Clinical)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Our best‑in‑class Phase 2 data … has generated significant momentum … preparations are well underway for our AVALON‑1 pivotal adaptive Phase 2/3 trial … expected to be initiated in the fourth quarter of this year.” — Malte Peters, CEO .
• “We are keenly focused on clinical execution and operational excellence … to ensure that we are sufficiently capitalized to reach these goals.” — Terry Coelho, EVP & CFO .
• “We have full alignment with our regulators in the U.S. and Europe, and our development team is rapidly progressing our program to the registrational trial.” — Jörn Aldag, on HB‑200 path and timelines (June 4 special call) .
• “In CPS 20 and above … ORR 53% … CR 18% … DCR 82% … PFS 16 months … OS ~90% at 9 months” — Mark Winderlich, CDO, ASCO dataset summary (June 4) .

Q&A Highlights

• Dataset maturation and confirmed responses: One previously unconfirmed response did not confirm after cutoff; others pending additional scans; new PRs continue to emerge as follow‑up accrues .
• Target population and control arm: Pivotal trial will enroll CPS ≥20 OPSCC and use pembrolizumab monotherapy as control, consistent with FDA discussions and standard of care for this homogeneous population; no added chemo in the control arm .
• Survival status and follow‑up: Of 19 CPS ≥20 patients, 16 alive at cutoff; only five deaths across the broader dataset; subsequent therapies standard (chemo ± pembro) .
• Enrollment feasibility and disease characteristics: No pronounced efficacy differences by baseline tumor burden; site feasibility supports Phase 2 ORR analysis targeted for 2026; accrual strategy follows regional incidence patterns .

Estimates Context

• S&P Global (Capital IQ) consensus for Q2 2024 EPS and revenue was unavailable at query time due to data access limits; as a result, we cannot assess beats/misses versus Street estimates. Models should reflect post‑Roche revenue normalization, milestone variability, and trial start timing rather than recurring product revenue at this stage [GetEstimates error].

Key Takeaways for Investors

• HB‑200 remains the core value driver; ASCO data in CPS ≥20 supports a potential accelerated approval strategy, with AVALON‑1 initiation in Q4’24 as the next binary catalyst .
• Financials are collaboration‑driven and lumpy; expect low baseline revenue post‑Roche termination, punctuated by occasional milestone receipts (e.g., $10M in April; $5M in July), implying continued GAAP losses during the pivotal ramp .
• Cash of $77.35M at 6/30 plus July milestone extends runway, but pivotal execution will keep capital planning in focus; management explicitly highlighted capitalization as a priority, and the reverse split improves listing compliance optics .
• New leadership (CEO Peters, CFO Coelho) aligns governance with late‑stage development needs, potentially accelerating BD/financing optionality (HB‑700 partnering under evaluation) .
• Trading setup: Near‑term catalysts include AVALON‑1 site activation/enrollment updates, additional HB‑200 data flow, and any partnering progress on HB‑700; absence of product revenue keeps shares sensitive to clinical/regulatory headlines.
• Risk checks: Reliance on a single registrational program, inherent clinical/regulatory risk, and funding needs through pivotal timelines remain primary considerations; no quantitative guidance to anchor near‑term models .