Executive Summary

Net loss narrowed sequentially to $25.8M with EPS of $(0.52), an improvement versus Q2 ($40.7M, $(0.83)) and Q1 ($46.8M, $(0.97)), reflecting sharply lower operating expenses in Q3 .
Operating expenses fell to $26.4M in Q3 from $43.0M in Q2 and $49.8M in Q1, driven by lower clinical development and professional services costs; other income declined due to interest expense on term loan repayment .
Cash, cash equivalents and marketable securities were $189.3M at quarter-end, down from $245.0M in Q2 and $272.7M in Q1, consistent with cash burn and restructuring actions taken earlier in the year .
Strategic update: following NEST-IN1 failure in infants, the company is exploring adult development paths for HIL-214/HIL-216 and business development/strategic alternatives, which are likely the next catalysts for the stock narrative .

What Went Well and What Went Wrong

What Went Well

Sequential cost discipline: R&D fell to $20.2M (from $26.6M in Q2), and G&A declined to $6.2M (from $8.1M in Q2), materially reducing total operating expenses to $26.4M .
Loss metrics improved: net loss narrowed to $25.8M and EPS improved to $(0.52), reflecting reduced operating spending and cost actions taken after Q2 .
Management is refocusing strategy: “The company is exploring the potential for continued development of its norovirus vaccine candidates in adults as well as business development related activities and other strategic alternatives,” signaling a pivot to adult programs and potential partnerships .

What Went Wrong

NEST-IN1 Phase 2b in infants failed its primary and secondary endpoints; HIL-214 in infants will be discontinued. “We believe the efficacy in the infant setting may have been impacted by the appearance of multiple emerging GII.4 strains,” per the CEO .
Other income dropped to $0.6M from $2.1M YoY, primarily driven by interest expense incurred on the repayment of the term loan facility in Q3 .
Balance sheet contraction continued as cash fell to $189.3M, total assets to $220.6M, and equity to $184.3M vs year-end 2023, reflecting cumulative losses and restructuring actions .

Financial Results

Quarterly progression (Q1 → Q2 → Q3 2024)

Metric	Q1 2024	Q2 2024	Q3 2024
Cash, Cash Equivalents & Marketable Securities ($USD Millions)	$272.7	$245.0	$189.3
Research & Development ($USD Millions)	$26.0	$26.6	$20.2
General & Administrative ($USD Millions)	$8.5	$8.1	$6.2
In-Process R&D ($USD Millions)	$15.3	$0.0	$0.0
Impairment Charges ($USD Millions)	$0.0	$8.235	$0.0
Total Operating Expenses ($USD Millions)	$49.797	$42.963	$26.380
Other Income ($USD Millions)	$2.968	$2.295	$0.557
Net Loss ($USD Millions)	$46.829	$40.668	$25.823
Net Loss per Share, Basic & Diluted ($USD)	$(0.97)	$(0.83)	$(0.52)

Notes:

Revenue and margin metrics were not reported; margins are not meaningful in absence of reported revenue .

Year-over-year comparison (Q3 2023 → Q3 2024)

Metric	Q3 2023	Q3 2024
Research & Development ($USD Millions)	$27.308	$20.165
General & Administrative ($USD Millions)	$6.603	$6.215
Other Income ($USD Millions)	$2.096	$0.557
Net Loss ($USD Millions)	$31.815	$25.823
Net Loss per Share, Basic & Diluted ($USD)	$(0.81)	$(0.52)
Weighted-average Shares (Basic & Diluted)	39,039,553	49,382,277

Balance Sheet Highlights

Metric	Dec 31, 2023	Jun 30, 2024	Sep 30, 2024
Total Assets ($USD Millions)	$344.434	$276.931	$220.622
Total Liabilities ($USD Millions)	$78.909	$72.001	$36.349
Stockholders’ Equity ($USD Millions)	$265.525	$204.930	$184.273

Guidance Changes

No formal financial guidance was provided for revenue, margins, OpEx, OI&E, tax rate, or segment-specific metrics. Management emphasized exploration of adult development paths for HIL-214/HIL-216 and business development/strategic alternatives instead of quantitative guidance .

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY/Quarter	None	None	Maintained
Operating Expenses	FY/Quarter	None	None	Maintained
Other Income/Expense	FY/Quarter	None	None	Maintained
Tax Rate	FY/Quarter	None	None	Maintained
Development Milestones	FY/Quarter	Q1: mid-2024 NEST-IN1 readout anticipated	Q3: pursuing adult development and BD alternatives	Reset

Earnings Call Themes & Trends

No earnings call transcript was available in the document set for Q3 2024; themes below reflect the evolution across company communications.

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q3 2024)	Trend
R&D Execution	Q1: Anticipated mid-2024 NEST-IN1 readout; plans to progress HIL-214 to Phase 3 with positive data	Q3: Post NEST-IN1 failure, discontinue infant development; explore adult development for HIL-214/HIL-216	Pivot from infant to adult focus
Workforce/Cost Actions	Q2: Announced ~40% workforce reduction to reduce OpEx and maintain core capabilities	Q3: Lower R&D and G&A expenses reported; sequential OpEx decline	Cost discipline materializing
Business Development/Strategic Alternatives	Q2: Indicated exploration following NEST-IN1 outcome	Q3: Explicitly exploring BD activities and strategic alternatives for vaccine candidates	Increased emphasis
Regulatory/Clinical Environment	Q1: Confidence in pathway pending mid-2024 data	Q3: Efficacy in infants impacted by emerging GII.4 strains; adult efficacy previously observed	More complex virology; adult setting favored

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 in this trial.” — Rob Hershberg, MD, PhD, Chairman & CEO .
“The company is exploring the potential for continued development of its norovirus vaccine candidates in adults as well as business development related activities and other strategic alternatives.” — Company statement in Q3 press release .
Prior quarter context: “With positive results from NEST-IN1, we expect HIL-214 to rapidly progress into Phase 3 clinical trials in both infants and older adults…” — CEO in Q1 press release (pre-NEST-IN1 outcome) .

Q&A Highlights

No Q&A section available, as no earnings call transcript was found in the document set for Q3 2024.

Estimates Context

We attempted to retrieve Wall Street consensus (S&P Global) for Q3 2024 EPS and revenue; data were unavailable due to a daily request limit error. As a result, we cannot quantitatively compare reported results to consensus this quarter. If needed, we can refresh and provide consensus once access is restored.

Key Takeaways for Investors

Sequential improvement in loss and EPS driven by lower R&D and G&A; total OpEx fell to $26.4M, supporting the effectiveness of cost-reduction measures .
Cash declined to $189.3M, implying ongoing burn but with a simplified operating footprint post-workforce reduction; runway will be influenced by adult program prioritization and BD outcomes .
Clinical strategy pivot: discontinuation in infants post-NEST-IN1 and renewed focus on adult pathways (HIL-214/HIL-216) where prior adult efficacy was observed, potentially de-risking next steps .
Near-term catalysts are strategic and programmatic (adult development plans, partnering, alternatives) rather than financial guidance; monitor for updates via press releases/8-Ks .
Other income softness tied to term loan repayment interest expense reduces ancillary P&L offsets; expect limited contribution from OI&E near-term .
Balance sheet contraction (assets/equity) is consistent with development-stage burn and restructuring; watch for partnering transactions to augment capital flexibility .
Without consensus estimates this quarter, narrative-driven moves are likely: clarity on adult indications, trial design, and partnership structure will be key to sentiment and valuation re-rating.

HilleVax, Inc. (HLVX)·Q3 2024 Earnings Summary