Executive Summary

Q3 2024 revenue was $4.70M; net loss narrowed to $13.84M versus $19.07M in Q3 2023, with operating expenses reduced year over year; cash ended at $59.96M, down from $77.35M in Q2 2024 .
The company completed enrollment (68 patients) in the Phase 2 H200-001 study of eseba-vec plus pembrolizumab four months ahead of schedule; late-breaking SITC 2024 data showed robust efficacy (ORR 52%, DCR 80%, preliminary median PFS >16 months; 12-month OS 83%) in CPS ≥20 patients, supportive of the pivotal AVALON-1 start in Q4 2024 .
R&D expenses fell materially to $15.57M (vs $19.75M in Q2 and $24.63M YoY), reflecting reprioritization and HB-300 pause; G&A rose to $6.73M due to leadership transition costs; restructuring ($0.88M) and small impairment ($0.17M) impacted results .
Consensus estimates from S&P Global were unavailable for Q3 2024 due to provider limitations; therefore, beat/miss analysis versus Street is not provided (S&P Global consensus unavailable).

What Went Well and What Went Wrong

What Went Well

Phase 2 enrollment completion ahead of schedule (68 patients) and initiation of adjuvant IIT at MSKCC; CEO emphasized “excellent progress across each program” and pipeline prioritization to optimize spending .
Late-breaking SITC poster expanded dataset: ORR 52% (55% at Phase 3 dose), DCR 80%, preliminary median PFS >16 months, 12-month OS 83%, with durable antigen-specific T-cell responses and manageable toxicity (7.6% serious TRAEs) .
HB-500 HIV program advanced; first subject dosed in Phase 1b and triggered a $5M milestone payment from Gilead in July, adding non-dilutive funding .

What Went Wrong

Revenue declined YoY to $4.70M (from $6.87M) due to lower partnering revenues following Roche collaboration termination; despite sequential improvement vs Q2 ($1.29M), topline remains collaboration-dependent .
G&A increased to $6.73M driven by personnel and professional fees tied to management transitions; restructuring ($0.88M) and impairment ($0.17M) further pressured opex in Q3 .
Cash decreased to $59.96M from $77.35M in Q2 and $92.96M in Q1; while milestone receipts provided offsets, operating cash burn remained significant .

Financial Results

Metric	Q3 2023	Q1 2024	Q2 2024	Q3 2024
Revenue ($USD Millions)	$6.87	$36.60	$1.29	$4.70
Net Income (Loss) ($USD Millions)	$(19.07)	$14.38	$(19.10)	$(13.84)
EPS (Basic) ($USD)	$(0.17)	$0.11	$(1.52)	$(1.10)
EPS (Diluted) ($USD)	$(0.17)	$0.11	$(1.52)	$(1.10)
R&D Expenses ($USD Millions)	$(24.63)	$(20.17)	$(19.75)	$(15.57)
G&A Expenses ($USD Millions)	$(4.91)	$(4.06)	$(3.95)	$(6.73)
Restructuring ($USD Millions)	—	$(1.27)	$(0.05)	$(0.88)
Impairment ($USD Millions)	—	—	—	$(0.17)
Total Operating Expenses ($USD Millions)	$(29.54)	$(25.49)	$(23.75)	$(23.35)
Loss from Operations ($USD Millions)	$(22.67)	$11.11	$(22.46)	$(18.64)
Cash & Equivalents ($USD Millions)	$108.10	$92.96	$77.35	$59.96

KPIs (clinical efficacy – SITC 2024 CPS ≥20 subset):

KPI	Data
Overall Response Rate (ORR)	52% (n=25 evaluable)
Disease Control Rate (DCR)	80%
Preliminary Median PFS	>16 months
12-month OS Rate	83%
Confirmed Responders Ongoing	66.7%
Serious TRAEs	7.6%

Segment breakdown: Not applicable (no reportable segments) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
AVALON-1 pivotal start (ese ba-vec + pembrolizumab, 1L OPSCC CPS ≥20)	Q4 2024	“On track/anticipated start Q4 2024; FDA-aligned design”	“On track to initiate in Q4 2024”	Maintained
Phase 2 H200-001 enrollment status	Q4 2024	“Accelerated enrollment momentum”	“Enrollment completed (68 patients) as of Oct 2024”	Achieved
Adjuvant IIT (MRD+ HNSCC) initial data timing	2026	Not previously specified	“Initial safety/efficacy data expected in 2026”	New
HB-700 development status	2024	“FDA IND clearance; Phase 1-ready”	“Strong preclinical dataset presented; Phase 1-ready”	Maintained/Expanded dataset
HB-500 (HIV) Phase 1b	2024	“Actively enrolling; milestone upon first dosing”	“First subject dosed; $5M milestone received (July)”	Progressed
HB-400 (HBV) trial status	2024	“Phase 1 trial led by Gilead”	“Phase 1a/1b enrollment completed (n=83)”	Progressed

Earnings Call Themes & Trends

Note: No Q3 2024 earnings call transcript was available in the document catalog; themes are derived from company press releases and 8-Ks.

Topic	Previous Mentions (Q1 2024)	Previous Mentions (Q2 2024)	Current Period (Q3 2024)	Trend
R&D execution (ese ba-vec)	FDA-aligned pivotal design; PRIME designation; pivotal start expected Q4	On track for AVALON-1; ASCO updated data; accelerated approval path	Enrollment completed; SITC late-breaker efficacy; adjuvant IIT initiated	Strengthening execution
Regulatory/designations	FDA alignment; EMA PRIME for HB-200 + pembrolizumab	FDA-aligned protocol; continued PRIME references	Late-breaking conference selection; pivotal timing reiterated	Reinforced
Leadership and governance	New CDO appointment	New CEO & CFO; reverse split; new board member	Board Chair change; CEO/CFO confirmed; board changes	Transition executed
Partnered programs (HB-500/HB-400)	HB-500 IND clearance; milestone eligibility	HB-500 first patient milestone ($5M); HB-400 Phase 1 ongoing	HB-500 first subject dosed; HB-400 Phase 1a/1b enrollment completed	Advancing
KRAS program (HB-700)	IND cleared; regained full rights	IND cleared; preclinical at ASCO	Comprehensive preclinical proof-of-concept presented; Phase 1-ready	Ready for clinical

Management Commentary

“HOOKIPA made excellent progress across each program in our pipeline in the third quarter... implemented a number of initiatives to optimize spending and ensure prioritization of resources.” — Malte Peters, MD, CEO .
“The expanded data presented at SITC 2024 are encouraging… highly consistent proof-of-concept... could lead to improved clinical outcomes and survival in HPV16+ R/M HNSCC CPS ≥20.” — Mark Winderlich, PhD, Chief R&D Officer .
“We are on track to initiate our pivotal AVALON-1 Phase 2/3 study... in the fourth quarter of 2024. We expect initial safety and efficacy data from the IIT in 2026.” — Malte Peters, CEO .
CFO (Q2): “Keenly focused on clinical execution and operational excellence... explore opportunities to ensure that we are sufficiently capitalized to reach these goals.” — Terry Coelho, EVP & CFO .

Q&A Highlights

No earnings call transcript for Q3 2024 was available in the document catalog; therefore, Q&A themes and guidance clarifications could not be assessed [ListDocuments returned 0 for earnings-call-transcript in Oct–Dec 2024].

Estimates Context

S&P Global consensus estimates for Q3 2024 EPS and revenue were unavailable due to provider request limitations; beat/miss analysis versus Street is not provided (S&P Global consensus unavailable).
Given collaboration-driven revenue and reduced R&D from program reprioritization, Street models may adjust opex run-rate lower and incorporate clinical de-risking from SITC data as AVALON-1 initiates in Q4 2024 .

Key Takeaways for Investors

Execution momentum: Phase 2 enrollment completed early; pivotal AVALON-1 remains on track for Q4 2024, a key potential stock catalyst as first patients are dosed .
Clinical de-risking: SITC late-breaker data (ORR 52%, DCR 80%, preliminary median PFS >16 months, 12-month OS 83%) strengthen the efficacy narrative for CPS ≥20 first-line R/M HNSCC and support the selected Phase 3 dose .
Cost discipline: R&D fell to $15.57M; however, G&A increased on transition costs and restructuring/impairment impacted Q3—watch for normalization post leadership changes .
Cash runway watch: Cash declined to $59.96M; milestone receipts offset but operating cash burn remains the primary pressure—capital plans and potential BD for HB-700 are important .
Partnership validation: HB-500 milestone ($5M) and HB-400 enrollment completion demonstrate progress under Gilead collaboration, supporting non-dilutive funding avenues .
KRAS opportunity: HB-700 now Phase 1-ready with broad mutant coverage and strong preclinical data; partnering could be a medium-term value lever .
Risk factors: Revenues remain dependent on collaborations post-Roche termination; pivotal trial initiation and subsequent readouts are key binary catalysts for sentiment and valuation .

Additional relevant press releases around Q3 2024:

SITC late-breaker efficacy update (Nov 11, 2024) .
Late-breaking poster announcement (Oct 31, 2024) .
Adjuvant MRD+ HNSCC IIT first patients dosed (Oct 30, 2024) .
HB-700 preclinical dataset presented (Sept 24, 2024) .

Prior quarters (for trend analysis):

Q2 2024 8-K and press release: Revenue $1.29M; net loss $(19.10)M; cash $77.35M; AVALON-1 on track; $5M Gilead milestone .
Q1 2024 8-K: Revenue $36.60M (Roche termination-related recognition); net income $14.38M; cash $92.96M; FDA alignment; PRIME designation; HB-700 IND cleared .

HOOKIPA Pharma Inc. (HOOK)·Q3 2024 Earnings Summary