Executive Summary

Q4 2023 was effectively a “full-year wrap” with no quarterly revenue; FY 2023 revenue was $5.44M driven by a $5.0M Merck milestone, implying Q4 revenue of $0 as FY equaled nine months .
Reported promising early clinical signals in VISTA-101: durable stable disease in monotherapy, and a partial response in combination with pembrolizumab; importantly, no dose-limiting toxicities were observed across dose levels .
Guidance/reset: cash fell to $5.8M at year-end and management disclosed substantial doubt about going concern; in Feb 2024 the company suspended new patient enrollment and began exploring strategic alternatives after investors indicated they would not fund the April 2024 tranche .
Catalysts: Q2 2024 clinical updates for monotherapy and combination cohorts were targeted, but near-term equity value hinges on strategic alternatives/resolution of financing uncertainty .

What Went Well and What Went Wrong

What Went Well

Early efficacy signals: 9/12 monotherapy patients with stable disease (mean duration 15 weeks); one NSCLC patient with 28 weeks SD despite CPI failure .
Combination cohort signals: one PR (54% reduction in target lesions, CR in non-target lesions) and one SD (24% reduction in target lesions) among first evaluable patients .
Safety profile: no dose-limiting toxicities or cytokine release syndrome observed at any dose level; dose-dependent biomarker activation consistent with on-target activity .

What Went Wrong

Funding reversal: investors indicated they will not fulfill the April 2024 funding obligation; company initiated a significant restructuring and is pursuing strategic alternatives .
Cash compression and going concern: year-end cash fell to $5.8M and management disclosed substantial doubt about ability to continue as a going concern absent additional funding .
Operational impact: suspension of new patient enrollment and a ~64% workforce reduction materially slows trial execution and increases uncertainty around program timelines .

Financial Results

Metric	Q2 2023	Q3 2023	Q4 2023
Revenue ($USD Millions)	$5.161	$0.000	$0.000 (FY $5.442 equals 9M $5.442)
Net Income (Loss) ($USD Millions)	$0.375	$(5.311)	$(2.660) (FY $(14.076) − 9M $(11.416))
EPS ($USD)	$0.04	$(0.46)	Not disclosed (company reported FY only)
Cash ($USD Millions, period-end)	$7.770	$7.562	$5.783
R&D Expense ($USD Millions)	$2.710	$1.909	$1.561 (FY $9.023 − 9M $7.462)
G&A Expense ($USD Millions)	$3.431	$2.077	$2.710 (FY $12.142 − 9M $9.432)

Notes:

No segment reporting applicable; revenues in 2023 primarily from a Merck milestone .
Q4 EPS not provided; FY EPS was $(1.28), but quarterly EPS cannot be derived due to weighted-average shares dynamics .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	As of Q3 2023	“Into early 2025,” premised on October 2023 and April 2024 financing closings	Substantial doubt about going concern; insufficient cash for next 12 months; exploring strategic alternatives	Lowered materially
Enrollment status (VISTA-101)	Q4 2023 → Feb 2024	Continued recruitment; first combo patient enrolled; SITC data forthcoming	Suspended new patient enrollment; existing patients may continue; workforce reduced ~64%	Lowered materially
Clinical data milestones	1H 2024	Initial monotherapy data by end-2023; combo dosing in Q3 2023	Additional monotherapy safety/efficacy and initial combo data targeted for Q2 2024	Timeline updated

No financial guidance for revenue, margins, OpEx, OI&E or tax rate was provided; guidance consisted of operational milestones and liquidity commentary .

Earnings Call Themes & Trends

No Q4 2023 earnings call transcript was found for KA; the company furnished a full-year press release within an 8-K, and no transcript is available in our document set [List: none found 2024-03 to 2024-04].

Topic	Previous Mentions (Q-2: Q2 2023)	Previous Mentions (Q-1: Q3 2023)	Current Period (Q4 2023)	Trend
R&D execution	Recruiting monotherapy cohorts; seven U.S. sites engaged; initial clinical data by end-2023	Announced positive monotherapy safety data; initiated combo with pembrolizumab; SITC presentation	Durable SD in monotherapy; PR in combo; cleared more cohorts	Scientific signals improving
Safety	Routine trial progress; no major safety commentary	Positive safety in monotherapy to-date	No DLTs or cytokine release syndrome at any dose	Reinforced benign profile
Biomarkers/technology	VISTA biomarker data and trial update presented at AACR	Biomarker agreements/publications	Dose-dependent cytokines; immune cell increases	Strengthening translational story
Funding/capital	$5M Merck milestone; cash runway into early 2025 (assuming financings)	Additional $2.7M in Oct; committed $22.5M expected in April 2024	Investors to not fund April tranche; going concern; strategic alternatives; enrollment suspended	Deteriorating materially
Strategic alternatives	Not discussed	Not discussed	Actively exploring strategic alternatives to maximize value	Newly introduced, critical

Management Commentary

“2023 was a productive year for Kineta… we initiated the Phase 1/2 VISTA-101 trial… and saw promising results… We look forward to sharing the clinical update in the second quarter and we will continue to explore strategic alternatives…” — Craig Philips, President .
“We are thrilled to share the significant progress… initial monotherapy data… initiated Part B… We continue to execute the VISTA-101 trial on time and on budget…” — Shawn Iadonato, Ph.D., CEO (Q3 update) .
“Steady progress… pleased with recruitment… expect to share initial clinical data by the end of the year… anticipate enrolling patients in Part B… moving one step closer…” — Shawn Iadonato, Ph.D., CEO (Q2 update) .

Q&A Highlights

No Q4 2023 earnings call transcript was available; therefore, no Q&A themes or guidance clarifications could be extracted [List: none found 2024-03 to 2024-04].

Estimates Context

Wall Street consensus for Q4 2023 EPS and revenue was unavailable via S&P Global due to missing CIQ mapping for KA; accordingly, estimate comparisons cannot be provided at this time [GetEstimates error: Missing CIQ mapping for 'KA'].
Given the FY and nine-month data, Q4 revenue was $0 and net loss was ~$2.66M; absent EPS consensus, we cannot judge a beat/miss versus Street expectations .

Key Takeaways for Investors

Clinical signals are constructive (durable SD in monotherapy; PR in combo) with a clean safety profile (no DLTs), supporting the VISTA mechanism and potential combination synergies .
Liquidity is the gating factor: $5.8M cash at year-end with going concern language and the April funding tranche failing; near-term equity outcomes hinge on strategic alternatives or fresh capital .
Operational slowdown (enrollment suspension, 64% workforce reduction) introduces timeline risk and could delay value-creating clinical readouts beyond Q2 2024 targets .
The Merck collaboration and prior milestone validate external interest; however, without additional financing, partnership leverage may be constrained .
Trade setup: headline risk around strategic alternative updates and financing outcomes is high; clinical updates, if maintained, could provide upside optionality but are secondary to balance sheet resolution .
Medium-term thesis requires capital access to continue VISTA-101 and expand combo cohorts; absent that, asset sale/merger outcomes become central to value realization .
Monitor disclosures for any reinstatement of funding, partnership transactions, or data readouts that could re-rate the risk profile .

Appendix: Clinical KPI Highlights

KPI	Detail
Monotherapy BOR	9/12 evaluable patients with stable disease; mean duration 15 weeks; one NSCLC patient with 28 weeks SD post-CPI failure
Combination BOR	One PR with 54% reduction in target lesions and CR in non-target lesions; one SD with 24% reduction in target lesions
Safety	No DLTs; no cytokine release syndrome across dose levels
Biomarkers	Dose-dependent induction of pro-inflammatory cytokines/chemokines; increases in non-classical monocytes, CD4+/CD8+ T cells, NK cells

Prior Quarter Financial Reference

Q2 2023: Revenue $5.161M; EPS $0.04; cash $7.770M (Merck milestone recognized) .
Q3 2023: Revenue $0; EPS $(0.46); cash $7.562M; “Expected cash runway into early 2025” predicated on financing closings .

KINETA, INC./DE (KA)·Q4 2023 Earnings Summary