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Phio Pharmaceuticals Corp. (PHIO)·Q4 2024 Earnings Summary

Executive Summary

  • Phio reported year-end results for Q4 2024 with continued progress in its Phase 1b trial of PH-762 and materially lower operating expenses year-over-year; net loss narrowed to $7.2M for FY 2024 vs $10.8M in FY 2023 due to cost rationalization actions .
  • Clinical updates were constructive: intratumoral PH-762 remained well tolerated with no dose-limiting toxicities, and Cohort 2 showed 2 complete responses (100% tumor clearance) and 1 partial response (90% clearance) among four patients; Cohort 3 is fully enrolled and the company expects to complete study enrollment in Q3 2025 .
  • Liquidity improved post year-end through financings: net proceeds of ~$6.8M subsequent to year-end and ~$4.0M during FY 2024; year-end cash was $5.4M (vs $8.5M at 12/31/23), and management believes capital is sufficient to complete the treatment phase of the Phase 1b trial .
  • Street coverage remains thin; Q4 2024 consensus EPS was -$1.23 with one estimate and revenue consensus was $0.0*, while the company did not disclose Q4 quarterly EPS or revenue figures in the 8-K .
  • Near-term catalysts: additional readouts from Cohort 3 and full enrollment by Q3 2025; longer-term value hinges on sustained safety/efficacy signals and capital access to support subsequent studies .

What Went Well and What Went Wrong

What Went Well

  • “To date, intratumoral injection of PH-762 has been well tolerated in all enrolled patients. There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects” .
  • Robust efficacy signals in Cohort 2: “At Day 36 (tumor excision), a complete response (100% tumor clearance) was reported for 2 patients, a partial response (90% tumor clearance) was reported for 1 patient and 1 patient had stable disease” .
  • Strengthened liquidity and runway: “Phio raised an aggregate of approximately $9.2 million… Additional gross proceeds of approximately $2.9 million were raised from the exercise of warrants… now believes it has sufficient capital to complete the treatment phase” .

What Went Wrong

  • Program deprioritization: Terminated the clinical co-development agreement with AgonOx after limited enrollment and cost assessment; the single patient receiving PH-762 + DP TIL showed tumor size reductions of 65%, 100% and 81% in three lesions, but resource constraints drove strategic reallocation .
  • Ongoing losses despite reductions: FY 2024 net loss of $7.2M remains significant, though improved vs $10.8M FY 2023; decreasing R&D and G&A reflect rationalization but underscore reliance on external capital .
  • Limited disclosure granularity for Q4: The company furnished year-end results rather than detailed Q4 quarterly P&L metrics, constraining precision in quarter-over-quarter comparisons vs estimates .

Financial Results

Quarterly Operating Metrics

MetricQ2 2024Q3 2024Q4 2024
Total Operating Expenses ($USD Millions)$1.91 $1.59 — (Not disclosed in Q4 release; FY 2024 total $7.39 shown below)
Net Loss ($USD Millions)$1.85 $1.52 — (Not disclosed in Q4 release; FY 2024 total $7.15 shown below)
Diluted EPS ($USD)-$3.62 -$1.54 — (Not disclosed)
Cash And Equivalents ($USD Millions)$4.70 $5.39 $5.38 (as of 12/31/24)

Notes: Q4-specific quarterly P&L metrics were not provided in the 8-K; company furnished year-end results .

Annual Operating Metrics (YoY)

MetricFY 2023FY 2024
Research and Development ($USD Millions)$6.33 $3.64
General and Administrative ($USD Millions)$4.37 $3.74
Total Operating Expenses ($USD Millions)$10.82 $7.39
Net Loss ($USD Millions)$10.83 $7.15
Diluted EPS ($USD)-$46.76 -$9.08
Cash And Equivalents ($USD Millions)$8.49 (12/31/23) $5.38 (12/31/24)

Clinical KPIs

KPIQ2 2024Q3 2024Q4 2024
Safety/Tolerability (DLTs)No DLTs in initial cohort; SMC recommended escalation Continued tolerability; opened screening for 3rd cohort “Well tolerated… no dose-limiting toxicities”
Cohort Enrollment StatusCohort 2 enrolling; 5 sites Cohort 2 fully enrolled; 6th site added Cohort 3 fully enrolled; study to complete enrollment in Q3 2025
Efficacy Signals (Cohort 2)—1 CR (100%), 1 PR (90%) reported among first two patients 2 CR (100%), 1 PR (90%), 1 SD reported among four patients

Segment breakdown: Not applicable; PHIO is a clinical-stage biotech without revenue segmentation .

Guidance Changes

Metric/TopicPeriodPrevious GuidanceCurrent GuidanceChange
PH-762 Phase 1b Enrollment CompletionQ3 2025Not previously specified“Phio expects to complete enrollment of all patients in the study in the third quarter of 2025.” Raised specificity (timeline provided)
Capital Sufficiency to Complete Treatment Phase2025Not previously specified“Company now believes it has sufficient capital to complete the treatment phase of the Phase 1b trial.” New statement
Financial Guidance (Revenue, Margins, OpEx, OI&E, Tax, Dividends)2025NoneNone provided in Q4 materials Maintained (no formal guidance)

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was available in our document catalog; themes below reflect press release narratives .

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
R&D Execution / Clinical ProgressSMC positive safety, dose escalation; Cohort 2 enrolling Cohort 2 fully enrolled; early CR/PR signals; 6th site added Cohort 3 fully enrolled; expanded CR count and maintained tolerability; enrollment to complete Q3 2025 Improving execution, expanding efficacy signals
Cost RationalizationHeadcount and consulting reductions begin to show in OpEx Continued reductions; Q3 OpEx down YoY FY R&D down 42%, G&A down 14% vs FY23 Sustained OpEx discipline
Capital Sourcing / RunwayWarrant exercises (~$3.1M gross) and Nasdaq compliance Additional financing flows, CFO appointment ~$9.2M gross (Dec–Jan), ~$2.9M warrants; ~$6.8M net post YE; sufficient to complete treatment phase Runway strengthened
Regulatory/Legal——Terminated AgonOx co-development; strategic focus on self-directed PH-762 trial Portfolio focus sharpened
IP/ScientificKorea patent on RXI-185; conference presence Peer-reviewed PH-804 article; multiple conferences 77 issued patents; presentation at AAD; PH-804 highlighted in journal IP base broad, scientific visibility rising

Management Commentary

  • “To date, intratumoral injection of PH-762 has been well tolerated in all enrolled patients. There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects” (Exhibit 99.1) .
  • “At Day 36... a complete response (100% tumor clearance) was reported for 2 patients, a partial response (90% tumor clearance) was reported for 1 patient and 1 patient had stable disease” (Exhibit 99.1) .
  • “The third dose cohort is fully enrolled... Phio expects to complete enrollment of all patients in the study in the third quarter of 2025” (Exhibit 99.1) .
  • “Phio raised an aggregate of approximately $9.2 million... Additional gross proceeds of approximately $2.9 million were raised from the exercise of warrants... now believes it has sufficient capital to complete the treatment phase” (Exhibit 99.1) .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available; therefore, Q&A themes and guidance clarifications are not applicable for this period .

Estimates Context

MetricQ4 2024 ConsensusQ4 2024 Actual# of Estimates
Primary EPS Consensus Mean-$1.23*Not disclosed 1*
Revenue Consensus Mean$0.00*Not disclosed 1*

Values retrieved from S&P Global.*

Implications:

  • With only one estimate and no disclosed quarterly EPS/revenue, estimate-based beat/miss cannot be determined for Q4 2024 .
  • Thin coverage suggests any new clinical efficacy or safety disclosures could drive forecast revisions once quarterly detail is provided.

Key Takeaways for Investors

  • Clinical signal quality is improving: additional complete responses and partial responses in Cohort 2, with continued tolerability; upcoming Cohort 3 data and full enrollment by Q3 2025 are key catalysts .
  • Cost discipline is durable: FY R&D down 42% and G&A down 14% YoY, narrowing FY net loss to $7.15M; supports extended runway while preserving core development priorities .
  • Balance sheet flexibility enhanced: ~$6.8M net proceeds post year-end and ~$4.0M net in FY 2024; management believes funding suffices for the Phase 1b treatment phase—reducing near-term financing risk but watch for post-enrollment needs .
  • Strategic focus sharpened: termination of AgonOx co-development consolidates resources on the intratumoral PH-762 program where efficacy signals are most tangible .
  • Data-flow matters more than quarterly P&L: absent revenue and limited quarterly EPS disclosure, stock narrative hinges on clinical updates, enrollment timelines, and safety/efficacy durability .
  • Near-term trading setup: monitor any AAD/medical conference data updates and 8-Ks for Cohort 3 results; thin analyst coverage means new data can disproportionately move the stock .
  • Medium-term thesis: If PH-762 continues to show strong local efficacy with favorable safety, non-surgical skin cancer treatment potential may attract partners or justify expanded trials; sustain capital access and execution milestones to bridge to Phase 2 .

Sources: Q4 2024 8-K and Exhibit 99.1 press release (year-end financial results and business update) ; Q3 2024 8-K press release ; Q2 2024 8-K press release .