Executive Summary

NEST-IN1 Phase 2b in infants failed to meet primary and secondary efficacy endpoints (vaccine efficacy 5%, 95% CI: -64%, 45%), leading the company to discontinue HIL-214 in infants and pivot exploration to adult programs including HIL-214 and Phase 1–ready HIL-216 .
Q2 2024 net loss widened to $40.7M vs. $27.9M YoY, driven by higher R&D and G&A, plus an $8.2M impairment charge; total operating expenses were $43.0M vs. $30.2M YoY, while other income was stable at ~$2.3M .
Cash, cash equivalents, and marketable securities declined sequentially to $245.0M from $272.7M (Q1) and $303.5M (FY-end), reflecting ongoing spend; liabilities fell modestly to $72.0M and equity to $204.9M .
Management announced a ~40% workforce reduction in Q3 2024 to reduce operating expenses while maintaining core capabilities as they evaluate adult development paths and potential business development options, a likely near-term stock reaction catalyst tied to expense trajectory and strategic pivot narratives .

What Went Well and What Went Wrong

What Went Well

Safety and immunogenicity of HIL-214 remained consistent with prior analyses and earlier studies, preserving optionality for adult development paths and continued platform credibility .
Other income held stable at $2.3M in Q2 2024 (same as Q2 2023), providing a modest non-operating offset to higher operating expenses .
Liquidity remained substantial at $245.0M, supporting strategic evaluation of adult programs and potential business development despite near-term setbacks .

What Went Wrong

NEST-IN1 did not meet efficacy endpoints; management will discontinue infant development of HIL-214. CEO: “We are disappointed that the NEST-IN1 study did not meet its primary efficacy endpoint…[efficacy] may have been impacted by the appearance of multiple emerging GII.4 strains” .
Net loss widened YoY to $40.7M and included an $8.2M impairment; R&D rose to $26.6M and G&A to $8.1M, underscoring higher operating costs amid clinical disappointment .
Cash decreased sequentially (Q4 → Q1 → Q2), reflecting sustained cash burn and necessitating cost actions, while equity fell to $204.9M, emphasizing the importance of partnerships/strategic collaborations cited in forward-looking risks .

Financial Results

Income Statement (YoY and QoQ)

Metric	Q2 2023	Q1 2024	Q2 2024
R&D Expense ($USD Millions)	$22.953	$25.978	$26.601
In-process R&D ($USD Millions)	—	$15.325	—
G&A Expense ($USD Millions)	$7.231	$8.494	$8.127
Impairment Charges ($USD Millions)	—	—	$8.235
Total Operating Expenses ($USD Millions)	$30.184	$49.797	$42.963
Other Income ($USD Millions)	$2.282	$2.968	$2.295
Net Loss ($USD Millions)	$27.902	$46.829	$40.668
EPS (Basic & Diluted, $)	$(0.74)	$(0.97)	$(0.83)
Weighted Avg Shares (Basic & Diluted)	37,951,735	48,460,185	49,179,109

Notes: Company reported no revenue line items; loss from operations equals total operating expenses, implying no recognized revenue in these periods .

Balance Sheet Snapshot

Metric	Q4 2023	Q1 2024	Q2 2024
Cash, Cash Equivalents & Marketable Securities ($USD Millions)	$303.483	$272.743	$245.040
Total Assets ($USD Millions)	$344.434	$314.175	$276.931
Total Liabilities ($USD Millions)	$78.909	$75.266	$72.001
Total Stockholders’ Equity ($USD Millions)	$265.525	$238.909	$204.930

KPIs (Operating Mix Highlights)

KPI	Q2 2023	Q1 2024	Q2 2024
R&D (% of Total OpEx)	76.0%	52.2%	61.9%
G&A (% of Total OpEx)	24.0%	17.1%	18.9%
IPR&D (% of Total OpEx)	0.0%	30.8%	0.0%
Impairment (% of Total OpEx)	0.0%	0.0%	19.2%

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Operating Expenses	Future periods (post-Q2)	None provided	Company announced ~40% workforce reduction in Q3 2024 to reduce OpEx while maintaining core capabilities	Lowered (qualitative)
Revenue/Margins/Tax/Dividends	N/A	None provided	None provided	Maintained (no guidance)

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript was available; themes below reflect press releases and prior earnings materials.

Topic	Previous Mentions (Q4 2023)	Previous Mentions (Q1 2024)	Current Period (Q2 2024)	Trend
R&D Execution (NEST-IN1)	Enrollment complete; on track for mid-2024 topline	“On track…mid-2024” topline; expectation to progress to Phase 3 pending positive results	NEST-IN1 failed to meet endpoints; discontinue infant program	Negative
Adult Program Development	Manufacturing progress for subsequent registrational trials (infants & older adults)	Confidence in advancing adults pending data	Exploring adult development for HIL-214 and HIL-216	Pivot/Refocus
Workforce/OpEx	Not highlighted	Not highlighted	~40% workforce reduction announced in Q3 to reduce OpEx	Cost Discipline
Clinical Safety/Immunogenicity	Not highlighted	Not highlighted	Safety/immunogenicity consistent with prior analyses	Stable
Business Development/Partnerships	Risk disclosures emphasize need for partnerships	Risk disclosures emphasize need for partnerships	Explicit consideration of BD activities for vaccine candidates	Increasing Priority

Management Commentary

“We are disappointed that the NEST-IN1 study did not meet its primary efficacy endpoint… We believe the efficacy in the infant setting may have been impacted by the appearance of multiple emerging GII.4 strains” — Rob Hershberg, MD, PhD, Chairman & CEO .
“Topline data from NEST-IN1…expected in mid-2024… With positive results…HIL-214 to rapidly progress into Phase 3 clinical trials in both infants and older adults” — Q1 commentary prior to the Q2 readout .
Company highlights exploring adult development paths for HIL-214 and HIL-216 and a ~40% workforce reduction to reduce operating expenses while maintaining core capabilities .

Q&A Highlights

No Q2 2024 earnings call transcript available; thus no Q&A to report. The company’s key disclosures were provided via press releases and the 8-K filing .

Estimates Context

Wall Street consensus EPS and revenue estimates via S&P Global were unavailable in this environment; therefore, we cannot assess beats/misses versus consensus for Q2 2024. Future comparisons should anchor on S&P Global consensus when accessible (consensus data was not retrievable due to API limits in this session).

Key Takeaways for Investors

The infant HIL-214 program has been discontinued; the strategic path pivots to adult development (HIL-214 and HIL-216), which preserves potential optionality but requires clinical and strategic validation .
Expense structure is set to tighten following a ~40% workforce reduction, providing a tangible near-term narrative on lowering operating costs as the company navigates its pivot .
Liquidity of $245.0M offers runway to evaluate adult programs and BD options; however, sequential cash declines underscore urgency for disciplined capital allocation and partnership exploration .
Q2 operating mix shows lower total OpEx vs. Q1 but includes impairment; without IPR&D charges seen in Q1, expense composition is shifting, suggesting future quarter comparisons should normalize for one-time items .
Risk disclosures emphasize potential need for additional capital and/or strategic collaborations to advance adult programs; investors should watch for partnership announcements or further cost actions .
Clinical narrative centers on strain dynamics (emerging GII.4) and adult efficacy precedent (NOR-211) — future adult trial designs and endpoints will be key determinants of value .
With no reported revenue and widening losses YoY, stock reaction will likely hinge on clarity around adult development timelines, cost reduction magnitude, and BD traction. Near-term trading setups may focus on updates to adult program plans and subsequent milestone catalysts .

HilleVax, Inc. (HLVX)·Q2 2024 Earnings Summary