Executive Summary

Reported year-end 2024 results with no commercial revenue, a wider GAAP net loss driven by Phase 3 preparation spending, and year-end cash and equivalents of $30.3M; management emphasized regulatory progress (Orphan Drug and Fast Track for amezalpat) and Phase 3 readiness in HCC .
Pivotal first-line HCC program de-risked by FDA/EMA alignment and Roche supply support; Phase 3 plan includes a pre-specified early efficacy analysis that could shorten time to primary analysis by up to 8 months, a potential upside catalyst pending funding/resources .
Operating expenses rose meaningfully YoY (R&D +$11.0M; G&A +$1.9M) due to CMO/CRMO, stock-based comp, and legal/consulting; management framed spending as necessary to execute on late-stage trials .
No formal financial guidance or quarterly Q4 break-out provided; S&P Global consensus for Q4 2024 and FY 2024 EPS/Revenue was unavailable as of this writing (estimates retrieval returned no data; see Estimates Context) .

What Went Well and What Went Wrong

What Went Well
- Regulatory and designations momentum: Amezalpat received Orphan Drug and Fast Track designations; FDA and EMA alignment for Phase 3 HCC plan secured; TPST-1495 Phase 2 “Study May Proceed” received for FAP .
- Strategic partnership: Agreement with Roche to supply atezolizumab globally for the pivotal HCC study; Phase 3 includes early efficacy analysis potentially accelerating time to readout by ~8 months .
- Management execution and positioning: “2024 was another year filled with significant progress and milestone achievements that position Tempest for a successful future,” per CEO Stephen Brady, underscoring execution despite “challenging capital markets” .
What Went Wrong
- Losses widened and spending increased YoY: FY2024 GAAP net loss ($41.8M) vs ($29.5M) in 2023; higher R&D ($28.5M vs $17.5M) and G&A ($13.6M vs $11.7M) tied to CMO/CRMO preparation for Phase 3 and stock-based comp/legal costs .
- Funding dependency persists: Advancement of pivotal HCC and TPST-1495 programs remains explicitly subject to securing additional resources, adding financing and execution risk to the timeline .
- No commercial revenue; continued operating losses and lack of formal financial guidance keep valuation tethered to clinical/regulatory milestones rather than fundamentals .

Financial Results

Annual results (USD Millions, except per-share; oldest → latest):

Metric	FY 2023	FY 2024
Revenue	N/A (no revenue reported)	N/A (no revenue reported)
R&D Expense ($)	$17.50	$28.48
G&A Expense ($)	$11.66	$13.55
Operating Loss ($)	($29.16)	($42.03)
Net Loss ($)	($29.49)	($41.84)
Net Loss per Share ($)	($1.91)	($1.50)
Cash & Equivalents (period-end) ($)	$39.23	$30.27

Quarterly trend (USD Millions, except per-share; oldest → latest):

Metric	Q2 2024	Q3 2024
Revenue	N/A (no revenue reported)	N/A (no revenue reported)
R&D Expense ($)	$5.84	$7.56
G&A Expense ($)	$3.75	$2.99
Net Loss ($)	($9.57)	($10.56)
Net Loss per Share ($)	($0.42)	($0.41)
Cash & Equivalents (period-end) ($)	$31.12	$22.12

KPIs and cash flow indicators:

KPI	Q2 2024	Q3 2024	FY 2024
Cash used in operating activities (YTD) ($)	$12.7 (YTD)	$22.9 (YTD)	N/A (not disclosed in YE release)
ATM Equity Proceeds ($)	N/A	$19.9 post-9/30/24	$28.6 in 2024 ATM proceeds
Cash & Equivalents ($)	$31.12	$22.12	$30.27

Notes:

The company reports no commercial revenue; financials are driven by operating expenses and financing activity .
Q4 2024 quarter-specific P&L was not separately disclosed; YE 2024 data provided instead .

Guidance Changes

Metric/Program	Period	Previous Guidance	Current Guidance	Change
Amezalpat (TPST-1120) Phase 3 start (1L HCC)	2025 start	Working to enable Q1 2025 start	Plan to advance to registrational study, subject to obtaining resources	Timing de-emphasized; resource-dependent
FDA/EMA alignment for Phase 3	HCC pivotal	FDA alignment incl. early efficacy analysis (up to ~8 months earlier)	Reiterated broad regulatory agreement (FDA/EMA)	Maintained
Roche support (atezolizumab supply)	HCC pivotal	Roche to supply atezolizumab; Tempest sponsors/leads	Maintained	Maintained
TPST-1495 (FAP) Phase 2 start	2024/early 2025 → 2025	2024 or early 2025; NCI-funded	Plan to advance in 2025; data expected 2026	Timing narrowed; data timing added
Financial guidance	FY 2025	Not provided	Not provided	Maintained

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was available; themes reflect Q2, Q3, and YE press disclosures.

Topic	Previous Mentions (Q2 2024, Q3 2024)	Current Period (Q4/YE 2024)	Trend
Phase 3 design and regulatory alignment	Q2: Advancing toward pivotal; strong OS data supports plan . Q3: FDA agreement on design and statistical plan including early efficacy analysis .	Broad regulatory agreement reiterated; EMA included .	Positive continuity; plan solidified
Roche support	Not highlighted in Q2;	Q3: Roche to supply atezolizumab globally; Tempest leads .	Maintained in YE achievements .
Clinical efficacy signal (HCC)	Six-month OS improvement; HR ~0.65 at Feb 2024 cutoff .	Reiterated survival benefit maintained across key subgroups .	Narrative consistent; de-risks program
Capital and funding	Q2: No ATM proceeds noted;	Q3: $19.9M ATM post-quarter .	YE: total 2024 ATM proceeds $28.6M; execution “despite challenging capital markets” .
Additional designations/approvals	—	—	Orphan Drug and Fast Track designations for amezalpat; “Study May Proceed” for TPST-1495 Phase 2 in FAP .

Management Commentary

“2024 was another year filled with significant progress and milestone achievements that position Tempest for a successful future... our lean team excelled, reporting key OS data… We have secured broad regulatory agreement with both the FDA and EMA on the Phase 3 plan and received both Orphan Drug and Fast Track designations from the FDA.” — Stephen Brady, CEO .
“Based on the positive randomized Phase 2 data and a Phase 3 plan we believe is designed for success, we were thrilled to receive broad agreement with the FDA. Coupled with Roche’s support for the Phase 3 study, the third quarter further solidified the foundation of a pivotal study...” — Stephen Brady, CEO .

Q&A Highlights

No Q4 2024 earnings call transcript was available; analysis reflects the 8-K Item 2.02 press release and other company press releases .

Estimates Context

S&P Global (Capital IQ) consensus for Q4 2024 and FY 2024 EPS and Revenue was not available; our estimates retrieval returned no data for “Primary EPS Consensus Mean” and “Revenue Consensus Mean” for these periods. Values retrieved from S&P Global.

Indicative comparison (no estimates available):

Metric	Q4 2024 Actual	Q4 2024 Consensus	FY 2024 Actual	FY 2024 Consensus
Revenue ($)	N/A (no revenue reported)	N/A	N/A (no revenue reported)	N/A
EPS (GAAP) ($)	N/A (no Q4-only EPS disclosed)	N/A	($1.50)	N/A

Key Takeaways for Investors

Late-stage readiness with multiple de-risking elements: FDA/EMA alignment, Roche supply, and early efficacy analysis built into Phase 3 design increase probability and potential timeline advantage in first-line HCC .
Compelling survival signal in randomized data (six-month median OS improvement; HR ~0.65 maintained) supports the thesis into Phase 3 and underpins strategic focus on HCC .
Spending stepped up appropriately for pivotal preparation; YoY increases in R&D and G&A were tied to CMO/CRMO, stock-based comp, and legal/consulting—watch for expense trajectory as Phase 3 ramps .
Balance sheet improved vs Q3 due to ATM activity (2024 ATM proceeds $28.6M), but management explicitly notes resource dependency to advance programs—financing remains a key risk/catalyst .
Regulatory catalysts broadened: Orphan Drug and Fast Track designations for amezalpat and “Study May Proceed” for TPST-1495 Phase 2 (FAP); TPST-1495 now guided to 2025 start with 2026 data—adds a second program catalyst path .
No formal financial guidance or consensus estimates available; stock likely to trade on clinical/regulatory headlines and funding developments rather than near-term fundamentals .

Supporting Documents Referenced

8-K (Item 2.02) and Exhibit 99.1 (Year End 2024 financial results and business update) .
Year-end 2024 press release (same content as Exhibit 99.1) .
Q3 2024 financial results press release and 8-K Exhibit 99.1 .
FDA “Study May Proceed” (Phase 3 HCC) press release (Nov 12, 2024) .
Roche supply agreement press release (Oct 10, 2024) .

Tempest Therapeutics, Inc. (TPST)·Q4 2024 Earnings Summary