Executive Summary

Theriva Biologics delivered a pre-revenue Q4 anchored by pipeline execution: VIRAGE (VCN-01 in metastatic PDAC) completed enrollment earlier in Q3 and management set topline readout for Q2 2025; FDA and EMA provided guidance on a potential Phase 3 design, de-risking next steps .
Liquidity: Cash and equivalents were $11.6M at 12/31/24; management expects runway into Q3 2025 (extended from Q2 2025 in the prior quarter) — a modest positive for near-term financing optionality .
Operating discipline: Q4 net loss was ~$4.45M (derived from FY less 9M), improving ~19% YoY vs Q4 2023 as non-cash impairments were concentrated in Q2–Q3; no further impairments were recorded in Q4 .
Strategic focus: SYN-004 Cohort 3 will not proceed absent grant/partner funding, underscoring prioritization of VCN-01 ahead of its Q2 2025 readout and potential Phase 3 initiation planning .
Street estimates: We were unable to retrieve S&P Global consensus in real time; third‑party aggregator pages show limited/absent quarterly estimates for TOVX. Treat estimate comparisons as N/A for Q4 2024 .

What Went Well and What Went Wrong

What Went Well

VIRAGE (PDAC) execution and regulatory momentum: “VIRAGE… is nearing a topline data readout… our interactions with regulatory agencies… have provided us with clear direction on the path forward to a potential pivotal trial” (CEO) .
Cash runway extension: Management now expects cash to fund operations into Q3 2025, extending from the Q2 2025 runway indicated in August, aided by disciplined spend and targeted non-dilutive support (e.g., Spanish funding) .
Non‑dilutive support and manufacturing capability: Awarded €2.28M combined loan/grant under Spain’s knowledge transfer program to support THERICEL manufacturing platform scale-up for adenoviral/AAV therapies .

What Went Wrong

Non‑cash impairments and elevated opex earlier in 2024: FY included $5.59M goodwill and $1.33M IPR&D impairments; Q3 also saw sharp G&A volatility due to contingent consideration changes, though Q4 did not record additional impairments .
Going concern language: The FY 2024 audited financials include an explanatory paragraph regarding the company’s ability to continue as a going concern, highlighting financing risk into key 2025 milestones .
Pipeline deprioritization pending funds: Despite favorable DSMC feedback, SYN‑004 Cohort 3 enrollment is paused unless grant/partner funding materializes, reflecting resource constraints and focus on VCN‑01 .

Financial Results

Quarterly P&L and Liquidity (oldest → newest)

Metric	Q2 2024	Q3 2024	Q4 2024
Total Operating Costs & Expenses ($USD Millions)	$8.488	$7.887	$4.580 (derived: FY $26.346 − 9M $21.766)
Total Other Income ($USD Millions)	$0.172	$0.161	$0.133 (derived: FY $0.693 − 9M $0.560)
Net Loss ($USD Millions)	$8.316	$7.726	$4.447 (derived: FY $25.653 − 9M $21.206)
Net Loss Per Share ($)	$(0.43)	$(6.81)	N/A (not disclosed)
Cash & Equivalents ($USD Millions)	$16.593 (as of 6/30/24)	$16.409 (as of 9/30/24)	$11.609 (as of 12/31/24)

Notes: Q4 figures derived from reconciling FY and 9M 2024 reported amounts. Q2 EPS reflects period prior to the 1‑for‑25 reverse split effective 8/26/24; Q3 disclosures retrospectively adjusted share figures for comparability .

YoY comparison for Q4

Metric	Q4 2023	Q4 2024
Net Loss ($USD Millions)	$5.485 (derived: FY 2023 $18.349 − 9M 2023 $12.864)	$4.447 (derived)

Result: Net loss improved by ~$1.04M YoY in Q4, primarily reflecting absence of incremental impairments in Q4 2024 and lower opex late in the year .

Operating expense mix by quarter (oldest → newest)

OpEx Component ($USD Millions)	Q2 2024	Q3 2024	Q4 2024
General & Administrative	$1.467	$2.302	$1.694 (derived: FY $7.396 − 9M $5.702)
Research & Development	$2.953	$2.734	$2.886 (derived: FY $12.031 − 9M $9.145)
Goodwill Impairment	$4.068	$1.526	$0.000 (no additional in Q4)
IPR&D Impairment	$0.000	$1.325	$0.000 (no additional in Q4)

KPIs/Other:

Cash Runway: Into Q3 2025 (management guide) .
Balance sheet: Cash & equivalents $11.6M; total stockholders’ equity $19.1M at 12/31/24 .

Segment breakdown: Not applicable (no reportable revenue segments disclosed) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
VIRAGE topline data timing (VCN‑01 in PDAC)	Q2 2025	N/A (not previously dated)	Topline in Q2 2025	Introduced
Cash runway	2025 liquidity	Into Q2 2025	Into Q3 2025	Raised
SYN‑004 Cohort 3 enrollment	Phase 1b/2a HCT	Could commence in H2’24 contingent on funding	Will not commence unless grant/partner secured	Lowered
Phase 3 design path (VCN‑01 PDAC)	Registrational readiness	“Initiated discussions” with agencies	Received FDA Type D minutes; EMA CHMP advice; planning End‑of‑Phase 2 before YE25	Advanced/clarified
Retinoblastoma regulatory	Program status	RPDD (US) granted; EU OMPD granted by EC (Oct)	Ongoing KOL/regulator engagement for pivotal design	Maintained

Earnings Call Themes & Trends

Topic	Q2 2024	Q3 2024	Q4 2024	Trend
VIRAGE (PDAC) progress	Enrollment nearing completion; FTD granted	Target 92 evaluable patients achieved; exploring Phase 3	Topline in Q2 2025; FDA/EMA design guidance received	Positive, toward pivotal
Cash runway	Into Q2 2025	Not reiterated	Into Q3 2025	Improving runway
Manufacturing scale-up	—	Spanish funding awarded; Merck KGaA EMEA finalist	Funding details/loan disbursed in Jan 2025	Strengthening
SYN‑004 funding path	Cohort 3 possible if funded	DSMC recommended proceed; seeking funds	No Cohort 3 without grant/partner	Deprioritized
Retinoblastoma (VCN‑01)	RPDD (US); positive Phase 1 signal	OMPD (EU) granted; positive study concluded	Pivotal protocol discussions advancing	Advancing
Impairments	$4.07M goodwill impairment	$1.53M goodwill + $1.33M IPR&D impairments	No additional Q4 impairments (FY total unchanged)	Largely recognized by Q3

Management Commentary

“We are very pleased with our clinical and regulatory achievements in 2024… VIRAGE… is nearing a topline data readout… clear direction on the path forward to a potential pivotal trial for VCN‑01 in [PDAC]” — Steven A. Shallcross, CEO/CFO .
“Considering the tremendous need for new therapies to treat pancreatic cancer, we have initiated discussions with regulatory agencies to explore the potential expansion of the VIRAGE Phase 2b study into a registrational Phase 3 trial…” — CEO (Q3) .
On portfolio prioritization: advancing VCN‑01 (PDAC/retinoblastoma), while pausing SYN‑004 Cohort 3 pending external funding/partner .

Q&A Highlights

We did not locate a Q4 2024 earnings call transcript for Theriva Biologics in our sources; as such, no Q&A themes to report for the quarter. Prior materials focus on press releases and 8‑K filings ; third‑party transcript aggregators largely list earlier periods or unrelated companies .

Estimates Context

Consensus (S&P Global): Not available for Q4 2024 in our programmatic request window; we therefore present estimate comparisons as N/A for this quarter. Third‑party aggregator pages also show limited/absent quarterly estimates for TOVX, consistent with minimal sell‑side coverage .
Implication: With no formal Street anchors, the stock is more likely to trade on pipeline milestones (VIRAGE Q2 2025 readout, Phase 3 path) and financing signals than on near‑term “beat/miss” mechanics .

Key Takeaways for Investors

Near‑term catalyst path is intact: VIRAGE topline in Q2 2025 and formal Phase 3 dialogue with FDA/EMA are the principal stock drivers over the next 1–2 quarters .
Liquidity is the swing factor: Cash to Q3 2025 reduces immediate pressure but still requires prudent spend and possible non‑dilutive/partnering initiatives ahead of Phase 3; monitor funding developments and cost trajectory .
Operating discipline improved by Q4 (no new impairments), yielding a ~19% YoY improvement in quarterly net loss; sustained control will help extend runway into catalysts .
Regulatory momentum across indications (PDAC Fast Track; retinoblastoma RPDD/OMPD) supports optionality, including potential Priority Review Voucher economics if retinoblastoma ultimately succeeds .
Risk balance: Pre‑revenue profile, going‑concern language, and concentration on one lead asset keep financing and trial risk elevated; trading likely correlates with VIRAGE data flow and any partnership signals .
Actionable: Position sizing should reflect binary clinical risk; consider catalysts calendar and potential financing windows; monitor additional non‑dilutive sources (grants/loans) and business development progress tied to VCN‑01 .

Sources

Q4/FY 2024 8‑K and press release: cash runway, VIRAGE timelines, FDA/EMA guidance, FY financials, going concern, balance sheet and P&L tables .
Q3 2024 8‑K and press release: VIRAGE enrollment completion, quarterly financials, impairment charges, Spanish funding highlights .
Q2 2024 8‑K and press release: financials, RPDD (retinoblastoma), FTD (PDAC), cash runway to Q2 2025 .
Additional relevant Q4 2024 press releases: EU OMPD (retinoblastoma), SYN‑004 DSMC Cohort 2 outcome .
Estimates/coverage context: third‑party aggregator page indicating absent quarterly estimates .

Theriva Biologics, Inc. (TOVX)·Q4 2024 Earnings Summary