Executive Summary

Q2 2025 showed continued clinical progress for PH-762 with 5 complete responses to date in cSCC and no dose-limiting toxicities, alongside operational execution on manufacturing readiness and financing; however, OpEx rose and net loss widened year over year .
EPS of -$0.45 missed Wall Street consensus of -$0.36 by $0.09, driven by higher R&D CRO pass-through costs from increased patient enrollment and higher salary-related G&A .*
Cash and equivalents were $10.8M at quarter-end, down from $13.3M in Q1 due to operating spend; subsequent warrant inducement and exercises raised ~~$2.5M gross (~~$2.2M after expenses), extending runway to complete Phase 1b treatment phase .
Stock-reaction catalysts: cGMP drug substance agreement for PH-762, positive pathology readouts (including CRs), and 5th (final) cohort enrollment initiation .

What Went Well and What Went Wrong

PH-762 safety/tolerability maintained across four cohorts; no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects; no clinical progression during treatment phase .
Efficacy signals: cumulative cSCC pathology responses include five complete responses (100% clearance), one near-CR (>90%), and one partial response (>50%) as of Q2; MCC patient had a partial response .
Manufacturing readiness: entered a comprehensive drug substance development services agreement with a U.S. manufacturer to support analytical/process development and cGMP production of PH-762, advancing toward later-stage readiness .

Expenses increased: R&D rose to $1.1M from $0.9M YoY due to higher CRO pass-through costs and consulting/salary expense; G&A rose to $1.2M from $1.0M YoY from higher salary costs .
Net loss widened to $2.2M from $1.8M YoY as higher operating expenses outpaced other income .
No formal financial guidance provided (beyond capital sufficiency statements), limiting visibility for investors on upcoming OpEx cadence and timing of next milestones .

Metric	Q4 2024	Q1 2025	Q2 2025
Net Loss ($USD Millions)	$1.626*	$1.769	$2.166
Total Operating Expenses ($USD Millions)	$1.674*	$1.872	$2.309
Diluted EPS ($USD)	-$1.43*	-$0.41	-$0.45
Cash & Equivalents ($USD Millions)	$5.382	$13.278	$10.775

Values with an asterisk were retrieved from S&P Global.

Estimate comparison (Q2 2025):

Metric	Consensus	Actual
EPS ($USD)	-$0.36*	-$0.45
Revenue ($USD Millions)	$0.00*	Pre-revenue; no revenue reported in Q2 statements

Values with an asterisk were retrieved from S&P Global.

Segment breakdown: Not applicable (single program focus).

KPIs (Clinical trial progress):

KPI	Q1 2025 (to date)	Q2 2025 (to date)
Patients treated (total across cohorts)	10	15
cSCC complete responses	4	5
cSCC near-complete responses (>90%)	1	1
cSCC partial responses (>50%)	1	1
cSCC non-responses (<50%)	3	6
MCC partial responses	—	1
Melanoma non-responder	1	1
Safety: DLTs/clinically relevant TEAEs	None observed	None observed

Metric	Period	Previous Guidance	Current Guidance	Change
Capital runway (treatment phase)	FY2025	Sufficient capital to complete Phase 1b treatment phase	Management continues to expect sufficient capital to complete the treatment phase; added ~$2.2M net from warrant exercises	Maintained (runway bolstered)
Revenue, margins, OpEx, OI&E, tax rate, dividends	FY2025	No formal guidance provided	No formal guidance provided	Maintained

Note: No Q2 2025 earnings call transcript was available.

Topic	Q4 2024 Mentions	Q1 2025 Mentions	Q2 2025 Current Period	Trend
PH-762 clinical progress	Cohorts 1–2 positive; Cohort 3 fully enrolled; CRs and stable disease noted	Cohorts 1–3 updated; 4th cohort enrolling; safety maintained	4 cohorts completed; strong cSCC responses; 5th (final) cohort enrolling	Progressing to final cohort
Manufacturing readiness	—	—	U.S. cGMP drug substance agreement for PH-762	Advancing CMC readiness
Capital sourcing	Raised $9.2M (Dec’24/Jan’25) and $2.9M gross from prior warrant exercises	Cash to complete Phase 1b treatment phase	~$2.5M gross warrant exercises; ~$2.2M net after expenses	Runway extended
Regulatory/legal	Terminated AgonOx co-development; redirected funding to self-directed trial	—	—	Focus on internal program
R&D execution	Cost rationalization and redeployment to PH-762 trial	Lower R&D YoY in Q1	R&D up YoY in Q2 due to CRO costs, higher consulting/salary	Spend increasing with enrollment

“We are delighted to be partnering with an organization known for its quality and expertise in oligonucleotide chemistry sequencing. Additionally, we value the strategic advantages to our management team of working with a U.S. based organization.” — Robert J. Bitterman, President & CEO, on cGMP drug substance manufacturing agreement .
“The positive safety and efficacy outcomes through the fourth cohort continue to indicate that PH-762 may present a viable non-surgical alternative in this large and continually expanding skin cancer market.” — Robert Bitterman, CEO & Chairman, on interim pathology results .
Clinical safety consistency: no dose-limiting toxicities or clinically relevant TEAEs; no clinical progression during treatment .

EPS: Actual -$0.45 vs consensus -$0.36; miss of $0.09, explained by higher CRO pass-through costs from increased patient enrollment and higher consulting/salary-related expenses (R&D and G&A increases) .*
Revenue: Consensus $0.00; company did not report revenue in Q2 statements; pre-revenue profile for the quarter .*

Values marked with an asterisk were retrieved from S&P Global.

Clinical momentum: 5 cSCC complete responses and continued safety/tolerability underscore PH-762 potential as a non-surgical option; 5th (final) cohort enrollment is a near-term catalyst .
Manufacturing de-risking: cGMP drug substance agreement for PH-762 aligns with forward CMC readiness and later-stage development needs .
Runway bolstered: ~$2.2M net proceeds post-quarter from warrant exercises support completing the Phase 1b treatment phase; cash at Q2-end was $10.8M .
Expense trajectory: R&D and G&A increases tied to enrollment and staffing drove an EPS miss vs consensus; monitor OpEx cadence as patient enrollment ramps .*
Near-term milestones: final cohort enrollment, additional pathology readouts, and potential manufacturing progress updates are likely to drive sentiment .
Absence of formal financial guidance: investors should focus on operational milestones (clinical and CMC) rather than revenue/profitability near term .
Estimate recalibration: given higher OpEx in Q2, models may need near-term expense adjustments until enrollment stabilizes; EPS consensus appears thin (1 estimate), implying potential volatility on results .*

Values marked with an asterisk were retrieved from S&P Global.