Executive Summary

Development-stage quarter with no revenue; net loss was $4.54M and diluted EPS was $(0.02). R&D stepped up on Phase 3 PV‑10 and PH‑10 MOA studies, while G&A declined year-over-year due to lower noncash share-based expense .
Cash and equivalents rose to $23.12M after a June equity offering; management extended cash runway guidance from “well into 2016” to “well into 2017,” reducing near-term financing risk .
Strategic progress: LOI with Boehringer Ingelheim China to explore PV‑10 commercialization in mainland China, Hong Kong, and Taiwan; continued discussions with Sinopharm units and others .
Noncash warrant liability tailwind from prior year faded (Q2’14 gain $3.52M vs Q2’15 gain $0.05M), normalizing reported losses quarter-over-quarter and year-over-year .
Key stock catalysts: China partnership formalization, Phase 3 melanoma study enrollment updates/interim data, liver program data at ESMO, and clarity on litigation matters .

What Went Well and What Went Wrong

What Went Well

Cash runway extended: “sufficient to meet current and planned operating needs well into 2017,” with optional capacity to direct Alpha Capital to purchase additional stock and a $50M at-the-market with Cantor .
Strategic partnering momentum: LOI with Boehringer Ingelheim China; active diligence by potential partners via data room, and ongoing Sinopharm discussions .
R&D execution: Phase 3 melanoma and PH‑10 MOA commencement drove higher R&D, reflecting program acceleration; management aims for rapid recruitment and diversified site mix across U.S., Australia, and other regions .

What Went Wrong

No revenue; business remains pre-commercial, with operating loss of $4.59M for the quarter and net loss of $4.54M .
Legal overhang continues (class actions and multiple derivative suits), and management notes listing risk uncertainty (no assurance of continued NYSE MKT listing) .
Noncash warrant liability benefit that helped Q2’14 results (gain $3.52M) largely disappeared in Q2’15 (gain $0.05M), removing a prior tailwind and exposing the full operating loss .

Financial Results

Income Statement vs Prior Periods and Prior Year

Metric	Q2 2014	Q1 2015	Q2 2015
Revenue ($USD)	$0	$0	$0
Research & Development ($USD)	$1,025,535	$2,280,706	$2,056,843
General & Administrative ($USD)	$2,966,569	$2,171,985	$2,367,041
Amortization ($USD)	$167,780	$167,780	$167,780
Total Operating Loss ($USD)	$(4,159,884)	$(4,620,471)	$(4,591,664)
Gain on Change in Warrant Liability ($USD)	$3,515,025	$94,026	$45,568
Net Loss ($USD)	$(643,416)	$(4,525,107)	$(4,544,949)
Diluted EPS ($USD)	$(0.00)	$(0.02)	$(0.02)
Weighted Avg Shares	175,554,000	185,196,323	187,792,643

Why changes: R&D rose YoY due to Phase 3 PV‑10 and PH‑10 MOA initiation; G&A declined YoY mainly from lower noncash share-based expense tied to stock prices. The warrant liability gain was a major YoY tailwind in Q2’14 that did not recur in Q2’15 .

Balance Sheet Key Items

Metric	Q4 2014	Q1 2015	Q2 2015
Cash and Equivalents ($USD)	$17,391,601	$14,170,733	$23,117,144
Stockholders’ Equity ($USD)	$25,189,876	$21,696,349	$30,246,789
Warrant Liability ($USD)	$146,560	$52,534	$6,966
Common Shares Outstanding (period-end)	184,796,275	185,972,159	204,558,259

Note: The Q4’14 8‑K press release stated equity of $26,184,158; subsequent 10‑Qs cite $25,189,876 for Dec 31, 2014, indicating a discrepancy later clarified in quarterly filings .

KPIs and Cash Flow

Metric	6M 2014	6M 2015
Cash Used in Operating Activities ($USD)	$(6,268,093)	$(8,219,212)
Net Proceeds from Sales of Stock/Warrants ($USD)	$4,350,000	$13,653,927
Proceeds from Exercises of Warrants/Options ($USD)	$4,347,886	$290,828
Net Change in Cash ($USD)	$2,429,793	$5,725,543
Cash and Equivalents at Period End ($USD)	$18,126,036	$23,117,144
R&D Expense (6M) ($USD)	$2,183,418	$4,337,549

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate	“Well into 2016”	“Well into 2017”	Raised
Need to Raise Capital for PV‑10 Development	Corporate	Do not anticipate needing additional capital; plan to monetize via regional licenses and spin-outs	Same strategic stance; broadened indications listed; caveat no assurance	Maintained
Alpha Capital Purchase Capacity	Financing Facility	Up to $30M	Up to $10M	Lowered/updated
Cantor Controlled Equity Offering	Financing Facility	$50M capacity	$50M capacity	Maintained
PV‑10 Phase 3 Timeline	Melanoma	Enrollment begun; 225 patients; primary endpoint PFS; estimated primary completion Sept 2017	Continue rapid recruitment; diversified site mix	Maintained trajectory
China Partnership	PV‑10 commercial path	MOU discussions with Sinopharm units	LOI with Boehringer Ingelheim China; continued Sinopharm discussions	Progressing
Funding Through Interim/Study Data	Corporate	Adequate funds well into 2016	“Sufficient…to fund operations through obtaining interim and potentially complete Phase 3 data”	Strengthened

Earnings Call Themes & Trends

Topic	Q4 2014 (Q‑2)	Q1 2015 (Q‑1)	Q2 2015 (Current)	Trend
Regulatory/legal	Phase 3 protocol amended/submitted; PH‑10 patent; business update	Class actions and derivative suits detailed; stay orders; consolidation	Litigation continues; motions and stays ongoing	Ongoing overhang
R&D execution (PV‑10 melanoma)	Amended Phase 3 protocol; IRB approvals	Enrollment begun; 225 patients; PFS primary endpoint; interim analysis plan	Rapid recruitment; multi-region site expansion plan	Advancing
China partnership	MOU groundwork (Sinopharm)	Active engagement; Sinopharm and other partners; investor conferences	LOI with Boehringer Ingelheim China; continued Sinopharm talks	Building momentum
Combination therapy with checkpoint inhibitors	—	Pfizer patent allowance; planned Phase 1b/2 design details	IP supports co-development; exploring transactions	Progressing
Cash runway/financing	Going concern assured at YE’14	“Well into 2016”	“Well into 2017”	Improving
Liver program	Expect initial data summer 2015	ESMO GI Congress poster accepted; Asia regulatory prep	Asia pathway and filings; partnering tie-in	Continuing

Management Commentary

Strategy and runway: “Therefore, our ability to continue as a going concern is reasonably assured… sufficient to meet our current and planned operating needs well into 2017…” .
Partnerships: “We have provided data…via a secure electronic data room… discussing transactions with potential partners in China, India, Brazil and Russia… recently announced a Letter of Intent… with Boehringer Ingelheim (China)” .
Development posture: “We believe… PV‑10 and PH‑10 provide… therapeutic products… we hope will result in one or more license transactions…” .
Enrollment push: “We anticipate potential sites throughout the world and are committed to facilitate enrollment… as quickly as possible” .

Q&A Highlights

Regulatory read-through from T‑VEC: Management sees improving environment for intralesional therapies; committee vote suggests favorable benefit-risk even without OS significance, supporting PV‑10’s local therapy hypothesis .
China path and timelines: Even without near-term definitive agreement, clinical work/regulatory filings in China to proceed; liver cancer is a compelling indication; protocol filing viewed as a partner trigger .
Stock price catalysts: Validation through big pharma partnerships, peer-reviewed data, Phase 3 progress, and liver data presentations highlighted as near-term drivers .
Combination studies: Planned Phase 1b/2 PV‑10 + checkpoint inhibitor design outlined (ORR at 3–4 months in 1b; PFS/OS in Phase 2), leveraging Pfizer IP allowance .

Estimates Context

Wall Street consensus EPS and revenue estimates for Q2 2015 via S&P Global were unavailable due to data access limits and limited coverage for this development-stage issuer; therefore, comparisons to consensus cannot be provided for this quarter. Values would have been retrieved from S&P Global if available.

Key Takeaways for Investors

Funding risk reduced: Cash of $23.12M and runway extended to well into 2017; sufficient to reach Phase 3 interim and potentially complete data, lowering near-term dilution risk .
Program acceleration: Elevated R&D reflects active Phase 3 PV‑10 and PH‑10 MOA studies; watch for interim readouts and enrollment updates as catalysts .
China optionality: LOI with Boehringer China plus ongoing Sinopharm discussions create multiple paths to regional commercialization; definitive deal would be a major stock catalyst .
Liver data and combo strategy: Upcoming/ongoing liver program data presentations (ESMO) and planned checkpoint inhibitor combination study expand PV‑10’s narrative beyond melanoma .
Legal overhang and listing risk persist; resolution or de‑risking of suits and continued compliance with NYSE MKT listing requirements are important to sentiment .
Noncash warrant effects normalized: With warrant liability down to $6,966, noncash swings should be smaller; operating results will reflect true burn more clearly going forward .

Additional Notes

Q2 2015 earnings press release confirmed no revenue and announced the business update call timing and replay details .
G&A YoY decrease primarily driven by lower noncash share-based expenses tied to lower stock prices; R&D increases due to Phase 3 PV‑10 and PH‑10 MOA commencement .
Equity financing in June: Public offering gross proceeds of $13.15M and tradable warrants (PVCTWS) provided incremental liquidity for development .

PROVECTUS BIOPHARMACEUTICALS, INC. (PVCT)·Q2 2015 Earnings Summary