Name: ZyVersa Therapeutics, Inc. Q3 2024 Earnings Call
Start: 2024-11-14T00:00:00.000Z

Executive Summary

Net loss narrowed year-over-year to $2.40M in Q3 2024 (vs. $2.90M in Q3 2023) as R&D and G&A expenses declined; diluted EPS was $(2.43) vs. $(30.18) in Q3 2023 .
Cash was $0.12M with an $11.15M working capital deficit; management reiterated substantial doubt about going concern and the need for additional financing .
Operational catalysts: VAR 200 Phase 2a in DKD expected to start Q1-2025 (data mid-2025); IC 100 IND targeted for Q2-2025 with Phase 1 in Q2/Q3-2025; obesity PoC mouse studies to begin as early as Q4-2024 .
Financing actions: ~$3.9M raised from the beginning of Q3-2024 to press release date, including ATM sales and warrant exercises; further warrant inducement program post quarter .

What Went Well and What Went Wrong

R&D timelines clarified and advanced: “Phase 2a clinical trial for Cholesterol Efflux Mediator TM VAR 200 in patients with diabetic kidney disease expected to begin Q1-2025” with initial data around mid-2025 .
New obesity-focused strategy around IC 100 with SAB formation and two PoC studies (monotherapy vs semaglutide; combo with semaglutide) starting as early as Q4-2024; IND planned Q2-2025 and Phase 1 initiation Q2/Q3-2025 .
Expense discipline: R&D down 35.3% YoY; G&A down 17.7% YoY, driven by lower professional fees, D&O insurance, and stock comp amortization completion .

Liquidity extremely constrained: Cash $0.12M; working capital deficit $11.15M; management disclosed substantial doubt about going concern and urgent need for financing .
Interest expense increased due to vendor-related interest charges; addition of disputed vendor invoices and accrued interest impacted other expenses .
Continuing material weakness in disclosure controls (segregation of duties); remediation not yet verified as effective .

Metric	Q1 2024	Q2 2024	Q3 2024
Revenue ($USD Millions)	$0.00	$0.00	$0.00
Research and Development ($USD Millions)	$0.51	$0.71	$0.44
General and Administrative ($USD Millions)	$2.31	$2.04	$1.83
Loss From Operations ($USD Millions)	$(2.83)	$(2.75)	$(2.27)
Net Loss ($USD Millions)	$(2.83)	$(2.76)	$(2.40)
Diluted EPS ($USD)	$(4.53)	$(3.31)	$(2.43)
Cash And Equivalents ($USD Millions)	$2.03	$0.12	$0.12

Segment breakdown

Segment	Revenue Q3 2024	Notes
Single operating segment	$0.00	Company operates one reportable segment

KPIs

KPI	Q1 2024	Q2 2024	Q3 2024
Working Capital Deficiency ($USD Millions)	$(6.68)	$(9.35)	$(11.15)
Accounts Payable ($USD Millions)	$8.13	$8.32	$9.28
Accrued Expenses & Other Current Liabilities ($USD Millions)	$1.45	$1.68	$2.26
Weighted Avg Shares – Basic and Diluted (units)	623,600	834,915	988,378

Metric	Period	Previous Guidance	Current Guidance	Change
VAR 200 Phase 2a (DKD) start	Q1 2025	Not detailed in Q1/Q2 filings	“Expected to begin Q1-2025; initial data mid-2025”	New/clarified
IC 100 IND submission	Q2 2025	Not detailed in Q1/Q2 filings	“IND submission planned Q2-2025”	New/clarified
IC 100 Phase 1 initiation	Q2/Q3 2025	Not detailed in Q1/Q2 filings	“Phase 1… in healthy overweight subjects at risk… Q2/Q3-2025; safety data H2-2025”	New/clarified
IC 100 Obesity PoC (DIO) mouse studies	Q4 2024	Not detailed in Q1/Q2 filings	“At least one study targeted to begin Q4-2024; two studies incl. mono vs semaglutide and combo”	New
Financing update	Q3-Q4 2024	N/A	Raised ~$3.9M from start of Q3 to press date; ATM ~$1.39M and warrant exercises ~$1.69M post quarter	New funds

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3)	Trend
R&D execution	Focus on VAR 200 and IC 100; pre-revenue status maintained	Specific timelines for VAR 200 Phase 2a and IC 100 IND/Phase 1; obesity PoC studies designed by SAB	Progressing from general development to defined milestones
Regulatory/legal & controls	Material weakness in disclosure controls noted; going concern disclosed	Material weakness persists; continuing going concern disclosure	Persistent risk; remediation ongoing
Financing/liquidity	Warrants exercised ($2.67M) improved near-term cash; cash decreased sharply Q2	Additional ATM and warrant inducement programs post-Q3; still month-to-month funding plan	Ongoing reliance on external capital
Product performance/preclinical	No product revenue; development emphasis	Obesity PoC DIO studies to assess metabolic parameters; IC 100 mechanism targeting ASC specks	Building preclinical evidence base
Disputed vendor invoices	Not present in Q1; disclosed Q2 with disputes	Accrued interest for vendor charges added to liabilities	Headwind in other expenses

“We are pleased to announce the progress that ZyVersa has made toward achieving our key near-term development milestones… Our Phase 2a clinical trial with Cholesterol Efflux MediatorTM VAR 200 in diabetic kidney disease is expected to begin Q1-2025, with an initial data read-out around mid-year 2025.” — Stephen C. Glover, CEO .
“Unlike NLRP3 inhibitors in development for obesity with metabolic complications, IC 100 targets ASC to inhibit multiple inflammasomes… IC 100 uniquely disrupts the function of ASC specks to attenuate chronic, systemic inflammation…” .
“We believe our near-term milestone achievement will be a key inflection point for ZyVersa that will drive shareholder value.” .

N/A — An earnings call transcript for Q3 2024 was not available in our document set.

Wall Street consensus (S&P Global) for Q3 2024 EPS and revenue was unavailable in this session due to data access limits; therefore, estimate-based comparisons are not provided. If coverage exists, we expect minimal variance given pre-revenue status; otherwise analysts likely focus on cash runway and milestone timing.
Values would be retrieved from S&P Global; unavailable in this session.

Liquidity risk is elevated: Cash of $0.12M and an $(11.15)M working capital deficit necessitate near-term financing; stock may trade on dilution risk and capital access .
Near-term catalysts: VAR 200 Phase 2a start in Q1-2025 and IC 100 IND/Phase 1 in 2025; any preclinical PoC readouts from obesity DIO models in H1-2025 could drive sentiment .
Operating discipline continues: R&D and G&A reduced YoY; sequential net loss improvement supports managed burn, but runway remains constrained .
Watch financing actions: ATM program and warrant inducements provide incremental cash but introduce overhang; monitor terms and potential dilution .
Process/control remediation: Material weakness persists; successful remediation could reduce execution risk over time .
Vendor dispute/interest accrual: Added interest expense highlights operational headwinds; resolution could alleviate other expense pressure .
Single-segment, pre-revenue profile means stock is driven by clinical/regulatory milestones and funding events rather than quarterly revenue/EPS beats .