Executive Summary

VCN-01 achieved primary survival and safety endpoints in the VIRAGE Phase 2b trial in first‑line metastatic PDAC; management is preparing a Phase 3 protocol, scaling manufacturing, and initiating partnering outreach .
Q2 2025 net loss was $13.06M ($1.93 EPS) vs. $8.32M ($10.72 EPS on prior share base) in Q2 2024; G&A spiked 662% to $11.2M on a $9.2M increase in contingent consideration tied to VIRAGE success, while R&D fell 34% YoY to $2.0M .
Cash was $12.1M at 6/30/25 (runway into Q1 2026); management reiterated expectation that R&D will increase as it completes Phase 2b, advances retinoblastoma, and scales GMP manufacturing .
Against S&P Global consensus, Q2 EPS missed: actual ($1.93) vs. estimate ($1.08); revenue expectations were $0 and the company reported no product revenue disclosure in the press note, making margins not meaningful for this period. Values retrieved from S&P Global.*
Near-term stock catalysts: ESMO mini-oral presentation of expanded VIRAGE data on Oct 20, 2025, Phase 3 design clarity and potential partnership updates .

What Went Well and What Went Wrong

What Went Well
- Positive VIRAGE topline: “VCN-01 achieved its primary survival and safety endpoints” in mPDAC; company moving to Phase 3 planning and manufacturing scale-up .
- Program breadth: VCN‑01 showed potential in retinoblastoma with Phase 1 safety/clinical outcome data presented at ASCO 2025, reinforcing platform optionality .
- Liquidity runway: Cash of $12.1M at quarter‑end; runway into Q1 2026 was reiterated (“cash position of $9.5M as of early August 2025 will be able to fund its operations into the first quarter of 2026”) .
What Went Wrong
- Earnings miss vs Street on EPS: Q2 2025 EPS ($1.93) vs. S&P Global consensus ($1.08); the delta was primarily driven by a $9.2M increase in fair value of contingent consideration recorded in G&A after VIRAGE met its primary endpoint **[894158_0001104659-25-075944_tm2522967d1_ex99-1.htm:1]. Values retrieved from S&P Global.
- Continued losses with limited cash: Net loss widened YoY to $13.06M; company remains pre‑revenue and dependent on external capital/partnerships to extend runway beyond Q1 2026 .
- Going concern context (context from FY): FY24 audit opinion included an explanatory paragraph about going concern, underscoring financing dependency until late‑stage partnering or additional capital is secured .

Financial Results

Core P&L and operating metrics

Metric	Q2 2024	Q1 2025	Q2 2025
Net Loss ($USD Millions)	$8.32	$4.32	$13.06
Diluted EPS ($)	$10.72	$1.55	$1.93
General & Administrative Expense ($USD Millions)	$1.47	$1.45	$11.18
Research & Development Expense ($USD Millions)	$2.95	$2.97	$1.95

Cash and runway

Metric	Q4 2024	Q1 2025	Q2 2025
Cash & Cash Equivalents ($USD Millions)	$11.61	$10.01	$12.12
Runway Commentary	Into Q3 2025	Into Q1 2026 (post raise)	Into Q1 2026; $9.5M as of early Aug-25

Revenue/margins

Revenue: Not disclosed in press materials; company remains pre‑revenue; margins not meaningful for Q2 2025 .
Note: Earnings dynamics driven by operating expenses, notably contingent consideration and program timing .

Estimates comparison

Metric	Period	S&P Global Consensus*	Actual	Surprise
EPS ($)	Q2 2025	-1.08*	-1.93	-0.85 (MISS)
Revenue ($)	Q2 2025	0.00*	Not disclosed	N/A

Values retrieved from S&P Global.*

Segment breakdown and KPIs

Segment revenue: N/A (no commercial revenue)
KPIs: Program milestones (VIRAGE positive, ESMO 2025 planned mini oral), manufacturing scale‑up progress, retinoblastoma Phase 1 outcomes .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate	Into Q1 2026 (post May 8 financing)	Into Q1 2026 (also cites $9.5M as of early Aug 2025)	Maintained
R&D Trend	Corporate	Anticipates R&D to increase as VIRAGE completes, Phase 3 plans, retinoblastoma, GMP scale‑up	Anticipates R&D to increase as VIRAGE completes, Phase 3 planning, retinoblastoma, GMP scale‑up	Maintained
Phase 3 Path (VCN‑01 PDAC)	Program	FDA/EMA advice received; plan Phase 3; End‑of‑Phase 2 meeting to be requested before end‑2025 (from FY update)	Preparing Phase 3 protocol; strategic partnering outreach ongoing	Advanced planning

No revenue, margin, OpEx dollar‑range, OI&E, tax rate, or dividend guidance was provided in Q2 materials .

Earnings Call Themes & Trends

Note: We did not locate a Q2 2025 earnings call transcript; themes are drawn from the 8‑K press release and Q2‑relevant press releases .

Topic	Previous Mentions (Q4 2024, Q1 2025)	Current Period (Q2 2025)	Trend
Phase 3 path (VCN-01 PDAC)	FDA Fast Track; FDA/EMA Phase 3 design guidance; End‑of‑Phase 2 meeting to be requested before end‑2025	Preparing Phase 3 protocol; partnering outreach underway	Advancing
Clinical efficacy (VIRAGE)	Topline expected Q2 2025; program momentum	Positive topline announced (OS/PFS/DOR signals) ; ESMO 2025 mini oral planned	Positive
Manufacturing scale‑up	Scaling plans referenced	Advancing VCN‑01 manufacturing using proprietary suspension cell line	Advancing
Retinoblastoma (VCN‑01)	Rare Pediatric Disease (FDA) and Orphan (EU) designations; Phase 1 completed	ASCO 2025 poster of Phase 1 outcomes	Positive visibility
Spend trajectory	Anticipated R&D to increase with program progress	Anticipates R&D to increase as programs advance and scale‑up expands	Maintained
Financing/runway	Cash runway into Q3 2025 (FY) ; extended into Q1 2026 post offering	Runway into Q1 2026 reiterated	Maintained

Management Commentary

“We have achieved a significant milestone with the positive readout from the Phase 2b VIRAGE trial… We are now preparing a study protocol for a potential Phase 3 clinical trial and advancing VCN‑01’s manufacturing scale‑up… [and] initiated strategic outreach to identify potential partners” — Steven A. Shallcross, CEO .
Retinoblastoma: Phase 1 safety and clinical outcomes presented at ASCO 2025 underscore potential in pediatric oncology .
Expense trajectory: R&D expected to increase as the company completes VIRAGE, plans Phase 3, advances retinoblastoma, and scales GMP manufacturing .

Q&A Highlights

We could not locate a Q2 2025 earnings call transcript or Q&A; management commentary in this recap is sourced from the 8‑K 2.02 press release and related Q2 press releases .

Estimates Context

EPS: Q2 2025 EPS missed S&P Global consensus (actual -$1.93 vs. -$1.08*); miss driven largely by a $9.2M contingent consideration fair‑value increase flowing through G&A after VIRAGE met its endpoint . Values retrieved from S&P Global.*
Revenue: Consensus was $0.00* and the company’s press release disclosed operating costs and losses without product revenue detail; margins are not meaningful at this stage . Values retrieved from S&P Global.*

Additional efficacy color (external coverage)

OncLive summarized VIRAGE topline: median OS 10.8 months for VCN‑01+SoC vs 8.6 months SoC (HR 0.57; 95% CI 0.34–0.96; P=0.0546), supporting survival benefit signals that may influence estimate revisions around development probability and partnering timelines .

Key Takeaways for Investors

VIRAGE positive topline plus ESMO data read‑throughs strengthen VCN‑01’s late‑stage profile and partnering case heading into Phase 3 design — near‑term catalyst path remains active .
EPS miss vs. S&P Global reflects non‑cash contingent consideration recorded in G&A; underlying R&D spend trended lower YoY in Q2 but is guided to increase as programs advance . Values retrieved from S&P Global.*
Liquidity extends into Q1 2026; however, the FY24 going‑concern context and ongoing cash burn make partnership funding and/or additional capital prudent focus areas before mid‑2026 .
Manufacturing scale‑up (proprietary suspension cell line) is a strategic enabler for Phase 3 readiness and future commercial viability; track progress alongside regulatory milestones .
Retinoblastoma data and regulatory designations diversify optionality beyond PDAC, broadening the platform’s value proposition .
Watch for: ESMO 2025 expanded VIRAGE data (Oct 20), Phase 3 protocol details and potential End‑of‑Phase 2 meeting timing, and any partnering announcements — all potential stock catalysts .

References and Sources:

Q2 2025 8‑K 2.02 press release and financials .
Q1 2025 8‑K 2.02 press release and financials .
FY 2024 8‑K press release, cash and going‑concern context .
May 2025 VIRAGE topline press release .
May 2025 ASCO/Investigator Meeting notice .
ESMO 2025 mini‑oral plan .
External coverage of VIRAGE topline (OncLive) .

Note: Where S&P Global consensus estimates are presented, values are marked with an asterisk and were retrieved from S&P Global.*

Theriva Biologics, Inc. (TOVX)·Q2 2025 Earnings Summary