Executive Summary

Tempest reported Q3 2024 net loss of $10.6M and diluted EPS of $0.41, with R&D spend rising as the company prepared for its pivotal Phase 3 trial in first-line HCC; cash and equivalents ended at $22.1M, with an additional $19.9M raised post-quarter under the ATM program .
Strategic progress was significant: FDA issued a “Study May Proceed” letter for the Phase 3 trial of amezalpat (TPST-1120), and Roche agreed to supply atezolizumab; both de-risk trial initiation targeted for Q1 2025 .
Cash runway guidance improved: management now expects liquidity to fund operations into Q4 2025, aided by ATM proceeds, versus guidance in Q1 2024 to fund operations into Q2 2025 .
Wall Street consensus estimates via S&P Global were unavailable for Q3 2024, so no beat/miss assessment can be made (S&P Global data unavailable due to request limits).

What Went Well and What Went Wrong

What Went Well

FDA regulatory milestone: Tempest received a “Study May Proceed” letter enabling the pivotal Phase 3 trial of amezalpat in first-line HCC, aligning on study design, dose, and a pre-specified early efficacy analysis to potentially shorten the time to primary analysis by up to eight months .
Partnership support: Roche will supply atezolizumab globally free of charge for the Phase 3 trial; Tempest retains all development and commercial rights to amezalpat .
Management confidence: “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,” said CEO Stephen Brady, highlighting momentum toward late-stage development .

What Went Wrong

Operating losses widened: Operating loss rose to $10.6M (+60% YoY) on higher external R&D and regulatory preparation; R&D increased to $7.6M (+79% YoY), driving the step-up in opex .
Balance sheet pressure: Cash declined to $22.1M at Q3-end from $31.1M in Q2 as trial preparations ramped; company relies on equity financing (ATM) and faces near-term debt amortization with $8.5M current loan payable and maturity in August 2025 .
Financing risk persists: The 10-Q reiterates the need for substantial additional capital for development and commercialization; inability to raise capital could force program delays or other strategic actions .

Financial Results

P&L and Cash Trends (Quarterly)

Metric	Q1 2024	Q2 2024	Q3 2024
Cash and Equivalents ($USD Millions)	$32.3	$31.1	$22.1
Research & Development ($USD Millions)	$4.34	$5.84	$7.56
General & Administrative ($USD Millions)	$3.63	$3.75	$2.99
Operating Loss ($USD Millions)	$(7.97)	$(9.58)	$(10.55)
Interest Expense ($USD Millions)	$(0.37)	$(0.37)	$(0.33)
Interest & Other Income ($USD Millions)	$0.44	$0.38	$0.32
Net Loss ($USD Millions)	$(7.90)	$(9.57)	$(10.56)
Diluted EPS ($USD)	$-0.36	$-0.42	$-0.41
Weighted Avg Shares (Basic/Diluted)	14,059,008	14,121,805	25,806,825

Year-over-Year Comparison

Metric	Q3 2023	Q3 2024
Research & Development ($USD Millions)	$4.22	$7.56
General & Administrative ($USD Millions)	$2.37	$2.99
Operating Loss ($USD Millions)	$(6.59)	$(10.55)
Net Loss ($USD Millions)	$(6.79)	$(10.56)
Diluted EPS ($USD)	$-0.48	$-0.41

Balance Sheet Highlights

Metric	Q1 2024	Q2 2024	Q3 2024
Total Assets ($USD Millions)	$44.38	$42.17	$33.84
Total Liabilities ($USD Millions)	$23.75	$25.23	$22.38
Stockholders’ Equity ($USD Millions)	$20.63	$16.94	$11.46
Current Loan Payable, net ($USD Millions)	$6.46	$8.65	$8.50
Noncurrent Loan Payable, net ($USD Millions)	$4.14	$2.01	$0.00

KPIs – Clinical Program (Amezalpat HCC, randomized study)

KPI	Primary Analysis (Apr 2023)	Updated (Feb 14, 2024)	Notes
Median OS (Triplet vs Control)	HR 0.59 (top-line)	21 vs 15 months; HR 0.65	Survival benefit maintained; stable HR
Survival Follow-up (Triplet vs Control)	—	20/40 vs 9/30 patients	Durability signal
Confirmed ORR (Triplet vs Control)	30% vs 13.3%	30% vs 13.3%	One PR converted to CR
β‑catenin subpopulation ORR/DCR	—	ORR 43%, DCR 100%	Biomarker-enabled efficacy

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Company funding horizon	Fund operations into Q2 2025 (Q1 press release)	Fund operations into Q4 2025 (post-ATM proceeds)	Raised
Phase 3 Trial Start (Amezalpat, HCC)	Study initiation	Planning to advance subject to FDA feedback (Q2)	“Study May Proceed” received; preparing to start in Q1 2025	Increased specificity
Atezolizumab Supply	Trial supply	None	Roche to supply atezolizumab free of charge for Phase 3	New support
ATM Program Capacity	Equity financing	New ATM launched in June; $205M authorized (program start)	~$196.4M remaining capacity at 9/30/24; $19.9M raised in Oct–Nov	Maintained capacity; executed raises
Rights Plan	Corporate defense	Rights Plan adopted in Oct 2023	Extended to post-2025 AGM; intended to protect shareholder value	Extended

Earnings Call Themes & Trends

Note: No Q3 2024 earnings call transcript was available in the document set; themes below reflect Q1/Q2 releases and Q3 press release/10‑Q.

Topic	Previous Mentions (Q1 & Q2 2024)	Current Period (Q3 2024)	Trend
Regulatory progress (FDA)	Advancing to pivotal Phase 3 pending FDA feedback	FDA “Study May Proceed”; agreement on endpoints, dose, and early efficacy analysis	Positive inflection/de‑risked
Partnership & supply	Global randomized data; collaboration history with Roche	Roche master clinical supply agreement; atezolizumab free-of-charge	Strengthened
R&D execution & spend	R&D up in Q2 on CRO/CMO activity	R&D up materially in Q3; amezalpat prep drove opex	Scaling for Phase 3
Financing strategy & runway	ATM program updated; runway into Q2 2025	$19.9M ATM proceeds post-Q3; runway into Q4 2025	Extended runway
Corporate governance	—	Rights Plan extended to protect shareholders amid perceived undervaluation	Defensive posture

Management Commentary

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… we hope [it] will result in a new and meaningful therapy for first-line HCC patients” .
Stephen Brady, on Roche agreement: “We’re excited to announce this agreement that supports the advancement of amezalpat into a pivotal study… [with] potential to significantly improve first-line liver cancer treatment” .
Sam Whiting, CMO: “Previously reported positive Phase 2 data underscore amezalpat’s potential to improve the survival of patients… our team is dedicated to advancing the program and bringing amezalpat to patients” .

Q&A Highlights

No Q3 2024 earnings call transcript was found; Q&A highlights and analyst clarifications were not available in the document set (no earnings-call-transcript located).

Estimates Context

Wall Street consensus estimates via S&P Global for Q3 2024 EPS and revenue were unavailable due to request limits; therefore, a beat/miss assessment versus consensus cannot be provided. Estimates may need to adjust to reflect Phase 3 de-risking and increased R&D spend trajectory as the program scales (S&P Global data unavailable).

Key Takeaways for Investors

Regulatory and partnership de-risking: FDA “Study May Proceed” and Roche supply materially increase confidence in Phase 3 initiation in Q1 2025 for first-line HCC .
Near-term cash runway extended to Q4 2025 after ATM raises, but the company still forecasts substantial capital needs to fund development; financing execution remains a core risk/driver .
R&D spend up sharply as Phase 3 manufacturing and CRO engagement accelerate; expect continued opex elevation as clinical operations scale .
Clinical signals remain strong: maintained survival benefit (21 vs 15 months), stable HR (0.65), and biomarker-enabled responses (β‑catenin) support differentiation in HCC .
Corporate defense indicates perceived undervaluation and desire to protect shareholder value during pivotal transition (Rights Plan extension) .
Catalysts: Phase 3 site activation/start in Q1 2025, trial progress updates, and potential disclosure of TPST‑1495 data in endometrial cancer and FAP study progression .
Trading setup: headline sensitivity to Phase 3 start/timeline, financing prints, and any updated survival/efficacy disclosures; balance sheet developments (ATM usage, debt amortization) can drive volatility .

Tempest Therapeutics, Inc. (TPST)·Q3 2024 Earnings Summary