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Phio Pharmaceuticals Corp. (PHIO)·Q1 2025 Earnings Summary
Executive Summary
- Q1 2025 showed disciplined OpEx control and improved net loss year-over-year as PH-762 advanced through cohort 3 with two complete pathologic responses, and safety supported escalation to cohort 4; cash rose to $13.3M, extending runway into Q2 2026 .
- No product revenue; basic/diluted EPS improved to $(0.41) vs $(0.47) in Q1 2024; total operating expenses fell 15% YoY to $1.872M, driven by lower R&D and G&A .
- Management reiterated expectations to complete Phase 1b enrollment in Q3 2025 and believes capital is sufficient to complete the treatment phase; continued cost rationalization supports focus on PH-762 .
- Wall Street consensus estimates for Q1 2025 EPS and revenue were unavailable via S&P Global; therefore no beat/miss assessment can be made (S&P Global consensus unavailable).
- Near-term stock catalysts include clinical data visibility (SID podium presentation May 10, 2025), safety-backed dose escalation, and completion of enrollment in Q3 2025; risks include going-concern uncertainty and potential tariff-related cost pressures for suppliers .
What Went Well and What Went Wrong
What Went Well
- Clinical efficacy signals: In cohort 3, 2/3 cSCC patients achieved complete pathologic response (100% tumor clearance); cumulative across cohorts 1–3, 4 complete responses, 1 near-complete (>90%), and 1 partial (>50%) with no clinical progression observed .
- Safety and tolerability: No dose-limiting toxicities or clinically relevant treatment-emergent adverse effects; SMC recommended dose escalation to cohort 4 .
- Strengthened liquidity: Cash increased to $13.3M, aided by ~$9.2M gross proceeds from December/January offerings and ~$2.9M gross from warrant exercises, supporting completion of the treatment phase .
What Went Wrong
- No product revenue; company remains pre-commercial and has yet to generate operating revenues, limiting margin analysis .
- Going-concern and financing dependence: Management disclosed substantial doubt about ability to continue as a going concern without additional capital; later notes project runway into Q2 2026 but financing risk persists .
- Potential macro/tariff headwinds: New U.S. tariffs (including on pharmaceuticals) could raise supplier costs or disrupt supply chains, impacting future manufacturing economics .
Financial Results
Year-over-Year (Q1 2024 → Q1 2025)
Quarter-over-Quarter (Q3 2024 → Q1 2025)
Note: Q4 2024 quarter-only detail not disclosed; Q3 2024 is the latest reported quarter.
KPIs (Clinical and Operating)
Guidance Changes
Earnings Call Themes & Trends
No Q1 2025 earnings call transcript found; themes summarized from SEC press releases and 10-Q.
Management Commentary
- “These positive outcomes continue to indicate that PH-762 may present a viable non-surgical alternative in this large and continually expanding skin cancer market.” — Robert Bitterman, President & CEO .
- “We are impressed with the continuing safety profile of PH-762 having now progressed through the first 3 escalating doses.” — Mary Spellman, MD, Acting CMO .
- “PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. The fourth cohort is currently enrolling and treating patients; Phio expects to complete enrollment in the third quarter of 2025.” — Company press release .
Q&A Highlights
No Q1 2025 earnings call transcript or Q&A was available; no additional guidance clarifications beyond press releases and 10-Q disclosures .
Estimates Context
- S&P Global consensus for Q1 2025 EPS and revenue was unavailable for PHIO; coverage appears limited, so no beat/miss determination can be made (S&P Global consensus unavailable).
- In absence of estimates, investors should anchor on reported EPS $(0.41) and net loss $(1.769)M, and clinical milestones for near-term narrative shifts .
Key Takeaways for Investors
- Clinical signal is strengthening: two complete pathologic responses in cohort 3 and four cumulative complete responses across cohorts support potential of intratumoral PH-762 in cSCC; safety has consistently supported escalation .
- Liquidity improved: cash rose to $13.278M; management expects runway into Q2 2026 and believes capital suffices to complete treatment phase of the ongoing Phase 1b trial .
- OpEx discipline: R&D and G&A both declined year-over-year, compressing total operating expenses by 15% and improving EPS vs Q1 2024 .
- Catalysts: SID podium presentation (May 10, 2025), ongoing cohort 4 enrollment, and expected completion of trial enrollment in Q3 2025 may drive sentiment and liquidity .
- Risks to monitor: going-concern disclosure and reliance on external financing despite improved runway; potential tariff-related supplier cost pressures .
- No revenue and single operating segment: commercial execution risk remains post-clinical; margin analytics are N/A until product revenues commence .
- Strategic focus: PH-894 IND deferred to prioritize PH-762 clinical execution; watch for future pipeline updates and any partnering activity to extend runway or accelerate development .