Executive Summary

Provectus reported no revenue and a net loss of $5.04M for Q2 2016; diluted EPS improved sequentially to $(0.02) from $(0.04) in Q1, as G&A fell vs Q1; cash declined to $4.89M and management disclosed going-concern risk given the cash burn .
Management emphasized near-term financing needs, stating they will need to raise money “this quarter,” while targeting at least one quarter’s burn and maintaining NYSE MKT stockholders’ equity >$6M (equity was $9.14M at quarter-end) .
Clinical pipeline updates: Phase 3 melanoma trial continued with expanded eligibility and six sites recruiting; interim analysis will be triggered at 81 progression events with timing clarity targeted for November, earliest by end of 2016 for the interim assessment .
Combination strategy advanced: PV-10 + Keytruda Phase 1b added a fourth center; liver programs progressed (HCC and NET studies), and new IP was allowed covering synthesis/use of Rose Bengal analogs .
Key stock catalysts: clarity on Phase 3 interim timing in November, initial Phase 1b combo data (likely early 2017), PH‑10 mechanism-of-action readout, and financing announcements to address liquidity risk .

What Went Well and What Went Wrong

What Went Well
- Sequential cost moderation: G&A dropped vs Q1 (absence of prior warrant incentive expense), improving EPS to $(0.02) from $(0.04) .
- Pipeline breadth and momentum: six Phase 3 sites recruiting; eligibility broadened (incl. Imlygic comparator), with CTO noting careful design to maximize success .
- Scientific validation and combination thesis: “Our results show that combining intralesional PV‑10 with anti‑PD‑1… yields marked increases in tumor‑specific T cell activation” (Moffitt data referenced by management) .
What Went Wrong
- Liquidity tightened: Cash fell to $4.89M; management highlighted going-concern risk and the need to raise capital promptly .
- Timeline uncertainty: Interim analysis timing remains uncertain; earliest at year-end, with update promised in November, reflecting prior delays acknowledged in Q1 .
- Elevated legal/compliance costs and internal control weaknesses persisted, inflating G&A vs prior year and requiring remediation efforts .

Financial Results

Metric	Q2 2015	Q1 2016	Q2 2016
Revenue ($USD)	$0	$0	$0
R&D Expense ($USD)	$2,224,623	$2,407,984	$2,004,962
G&A Expense ($USD)	$2,367,041	$6,099,232	$3,039,874
Operating Loss ($USD)	$(4,591,664)	$(8,507,216)	$(5,044,836)
Net Loss ($USD)	$(4,544,949)	$(8,506,303)	$(5,044,082)
Diluted EPS ($USD)	$(0.02)	$(0.04)	$(0.02)
Net Income Margin %	N/M (no revenue)	N/M (no revenue)	N/M (no revenue)

KPIs (balance sheet/operational):

KPI	Q2 2015	Q1 2016	Q2 2016
Cash & Equivalents ($USD)	N/A	$9,760,997	$4,891,313
Stockholders’ Equity ($USD)	N/A	$14,184,248	$9,140,166
Weighted Avg Shares	187,792,643	205,278,509	212,829,352

Segment breakdown: Not applicable; company had no revenue and reports as a single clinical-stage entity .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Phase 3 Interim Analysis Timing	Melanoma	Mid/end of 2016 or early 2017 (Q1 call)	Earliest by end of 2016; update expected on November call	Delayed/clarified timeline
Liquidity/Capital Raise	Near-term	Adequate funds into 2017 per Q1 10‑Q (absent further injections)	Will need to raise money “this quarter”; aim to cover at least one quarter burn	Tightened; immediate raise
NYSE MKT Equity Threshold	Ongoing	Maintain >$6M equity	Equity $9.14M at 6/30; maintain compliance focus	Maintained

No formal quantitative revenue/margin/OpEx guidance was issued; management commentary focused on financing plans and clinical timelines .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2015, Q1 2016)	Current Period (Q2 2016)	Trend
Phase 3 Melanoma Interim	Q4: interim could come in 2016; protocol amended; Imlygic comparator added	Interim trigger at 81 events; earliest year-end; clarity in November	Timing pushed; process clarified
Combination Therapy (PV‑10 + Keytruda)	Initiated Phase 1b/2; plan 5–7 sites; strategy to pave broader combos	Fourth center opening; data likely first half 2017	Steady progress; data timing set
HCC/Asia Strategy	Plan to move to Asia; KOL meetings; sorafenib combo contemplated	Continuing expansion; Asia studies in planning; U.S. centers added	Advancing regionally
PH‑10 MOA	Clinical work completed; analysis pending; FDA meeting planned	Initial analysis nearing; aim to fast-track publication/partner discussions	Nearing readout
Financing/Liquidity	Warrant exchange; minimize dilution; adequate funds into 2017	“Will need to raise money this quarter”; cover quarter burn; focus on non-dilutive options	Urgency increased
Legal/Controls	Addressed former CEO issues; audit committee investigation	Material weakness persists; remediation ongoing; higher legal costs	Ongoing remediation

Management Commentary

Interim CEO on Phase 3 timing: “We should have a better handle… on communicating more precisely on the November call… interim assessment would by the end of the year at the earliest” .
CTO on combination strategy: “Non‑clinical data strongly supports the strategy and [we] have a high degree of confidence this study will be successful” .
Moffitt data cited by management: “Combining intralesional PV‑10 with anti‑PD‑1… yields marked increases in tumor‑specific T cell activation” (Shari Pilon‑Thomas, Ph.D.) .
IP strengthening: “Notice of Allowance… covering additional aspects of our process for synthesizing halogenated xanthenes… provides a significant potential commercial lifetime” .
Liquidity stance: “We will need to raise money this quarter… focused on doing the kinds of financing that is the least dilutive possible” .

Q&A Highlights

Interim analysis mechanics/timeframe: Interim at 50% of required events (81 progressions); earliest by year-end; detailed protocol sections explained by CTO .
Financing needs and approach: Management expects to raise funds in the current quarter; targeting at least a quarter of burn; striving for least dilutive structures (including warrant exchanges) .
Combination trial status: Fourth center opening; Phase 1b readout likely first half of next year; potential to share early data confidentially with partners .
Partnerships and regional strategy: Continued work with Boehringer Ingelheim in China; ongoing discussions with Sinopharm; broader Asia HCC plans .
Listing compliance and governance: Focus on NYSE equity threshold; material weaknesses acknowledged; remediation steps outlined .

Estimates Context

Wall Street consensus EPS/revenue estimates via S&P Global for Q2 2016 were not available in our session; management did not provide formal quantitative guidance. As a result, no beat/miss vs estimates can be assessed .

Key Takeaways for Investors

Liquidity risk elevated: Cash dropped to $4.89M, with going-concern language and an explicit plan to raise funds this quarter—near-term financing headlines are likely .
Sequential P&L improvement: Net loss narrowed from $8.51M (Q1) to $5.04M (Q2) as G&A normalized without warrant incentive cost, improving EPS to $(0.02) .
Clinical catalysts: November update on Phase 3 interim timing; earliest interim assessment at year-end, plus early-2017 combo readout potential .
Combination thesis gaining support: Moffitt’s data and management’s strategy reinforce PV‑10’s role alongside checkpoint inhibitors, a potential partnering narrative .
Regional expansion: HCC/NET liver programs advancing with Asia emphasis and added U.S. centers—watch for conference publications and site activations .
Governance/legal tail risk: Material weakness remediation and legal/compliance costs continue; monitor for resolution and expense normalization .
Listing compliance stable for now: Equity at $9.14M (> $6M requirement) but dependent on timely financing and execution .

PROVECTUS BIOPHARMACEUTICALS, INC. (PVCT)·Q2 2016 Earnings Summary