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INFINITY PHARMACEUTICALS, INC. (INFIQ)·Q1 2022 Earnings Summary

Executive Summary

  • Infinity Pharmaceuticals reported Q1 2022 royalty revenue of $0.652M, net loss of $12.4M, and EPS of $(0.14); cash and investments were $67.1M at quarter-end .
  • Guidance was maintained: 2022 net loss $45–$55M and year-end cash $25–$35M; no additional funding assumed .
  • Operational focus advanced toward MARIO-4 (front-line mTNBC, registrational) by year-end 2022 and MARIO-P platform program starting in Q3 2022 .
  • No Q1 2022 earnings call transcript was available via our sources; company held a call on May 3, 2022 per press release .

What Went Well and What Went Wrong

What Went Well

  • Clear clinical execution path: MARIO-4 registrational study design progressing with global regulatory meetings; targeting PFS and OS endpoints and both PD-L1(-) and PD-L1(+) cohorts .
  • Positive prior data underpin strategy: MARIO-3 showed median PFS of 11.0–11.2 months in PD-L1(+) and 7.3 months in PD-L1(-) vs IMpassion130 benchmarks; MARIO-275 showed mOS of 15.4 months vs 7.9 months control, reinforcing mechanism and patient benefit .
  • Management confidence and continuity of guidance: “We continue to leverage eganelisib’s unique mechanism of action and differentiated clinical data to advance our clinical development program and maximize the value of eganelisib for patients and shareholders.” — Adelene Perkins, CEO .

What Went Wrong

  • Ongoing losses widened modestly YoY: net loss of $12.4M vs $11.6M in Q1 2021; R&D up to $9.0M from $8.2M driven by compensation and development activities .
  • Cash decreased sequentially to $67.1M from $80.7M at year-end 2021, reflecting operating spend ahead of registrational activities .
  • Lack of earnings call transcript access limits visibility into near-term BD or financing updates; press release states no additional funding assumed in guidance .

Financial Results

MetricQ1 2021Q2 2021Q3 2021Q1 2022
Royalty Revenue ($USD Thousands)$467 $512 $428 $652
Research & Development Expense ($USD Thousands)$8,201 $7,957 $7,073 $8,990
General & Administrative Expense ($USD Thousands)$3,566 $3,498 $3,847 $3,676
Total Operating Expenses ($USD Thousands)$12,049 $11,763 $11,178 $13,059
Net Loss ($USD Thousands)$(11,629) $(11,269) $(10,713) $(12,436)
Diluted EPS ($)$(0.15) $(0.13) $(0.12) $(0.14)
Cash, Cash Equivalents & AFS Securities ($USD Thousands)n/a$97,258 $90,088 $67,140
Weighted Avg Shares (Basic & Diluted)75,728,176 88,661,934 88,766,912 89,155,311

Estimate vs. Actual (Q1 2022)

MetricWall Street Consensus (S&P Global)Actual
Revenue ($USD)Unavailable via S&P Global$652,000
EPS ($)Unavailable via S&P Global$(0.14)

Note: Consensus estimates for INFIQ were not available via S&P Global at the time of analysis.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Loss ($USD Millions)FY 2022$45–$55 (Mar 29, 2022) $45–$55 (May 3, 2022) Maintained
Year-End Cash & Investments ($USD Millions)FY 2022$25–$35 (Mar 29, 2022) $25–$35 (May 3, 2022) Maintained

Assumptions: Guidance excludes additional financing or BD activities .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2021)Previous Mentions (Q3 2021)Current Period (Q1 2022)Trend
R&D Execution (MARIO-275 OS, MARIO-3 PFS)mOS 15.4 vs 7.9 control; early PFS improvement; strong DCR; mechanism consistent with macrophage reprogramming PFS prolongation vs IMpassion130; OS extension in UC; safety consistent; preparing SABCS update MARIO-4 registrational plan, endpoints PFS/OS; MARIO-P platform launch planning Strengthening execution toward registration
Regulatory/Trial DesignPlanning optimal registrational paths in UC and TNBC; Fast-Track designations noted Registrational trial planning referenced Design confirmation with global regulators for MARIO-4 Advancing to pivotal design confirmation
Cash Runway/SpendCash $97.3M; net loss guidance $40–$50M Cash $90.1M; end-year cash $70–$80M guidance reiterated Cash $67.1M; 2022 net loss $45–$55M; YE cash $25–$35M Cash trending down as programs advance
Business Development/Financing$92M raise earlier in 2021; BD not in guidance Leadership additions (CSO/CMO/Board) Guidance excludes new funding/BD Funding-neutral guidance maintained
Safety/MechanismOn-mechanism immune activation; PD-L1 conversion; consistent safety profiles Safety consistent with components; no new signals Continued emphasis on mechanism-driven differentiation Consistent safety/mechanism narrative

Management Commentary

  • “We are pleased to further advance the development of eganelisib, building on our encouraging MARIO-3 results, by initiating our first registration study, MARIO-4, in front-line metastatic TNBC by the end of this year… We continue to leverage eganelisib’s unique mechanism of action and differentiated clinical data to advance our clinical development program and maximize the value of eganelisib for patients and shareholders.” — Adelene Perkins, CEO .
  • “We are aggressively advancing a registration focused study in TNBC… We also continue to be encouraged by the overall survival benefit seen in patients with urothelial cancer… expanding the development of eganelisib in a platform study in additional indications…” — Robert Ilaria, Jr., M.D., CMO .

Q&A Highlights

  • The company held a conference call on May 3, 2022, but a transcript was not available through our sources; webcast archive was referenced for 30 days on the investor site .
  • Without transcript access, no formal Q&A themes or guidance clarifications can be cited beyond the press release’s stated financial guidance .

Estimates Context

  • S&P Global consensus estimates for Q1 2022 revenue and EPS were not available for INFIQ at the time of analysis. Results are therefore presented without an estimates comparison and investors should monitor for the next consensus update.
  • Actuals: Revenue $0.652M, EPS $(0.14), net loss $12.4M .

Key Takeaways for Investors

  • The clinical strategy is converging on a pivotal MARIO-4 trial in front-line mTNBC with PFS/OS endpoints and a PD-L1 stratified design, supported by encouraging MARIO-3 and MARIO-275 datasets; regulatory interactions to finalize design are underway .
  • Guidance is unchanged: 2022 net loss $45–$55M and YE cash $25–$35M, implying continued cash burn and likely future financing or BD need beyond current plans; management explicitly excludes additional funding from guidance .
  • Q1 revenue increased YoY ($0.652M vs $0.467M), but net loss widened modestly as R&D spend rose to drive registrational readiness; sequential cash declined to $67.1M .
  • The differentiated macrophage reprogramming mechanism and demonstrated OS/PFS signals across PD-L1 statuses create a potential catalyst path as MARIO-4 initiates and 2H 2022 data updates arrive (MARIO-3 TNBC/RCC, MARIO-275 UC, HNSCC IST) .
  • Near-term trading implications: stock likely sensitive to trial initiation timing, regulatory feedback on endpoints, and any BD/financing announcements given balance sheet trajectory .
  • Medium-term thesis: confirmation of efficacy in registrational settings (especially PD-L1(-) populations) could unlock significant value; monitor safety consistency, translational biomarkers (PD-L1 conversion), and durability of OS/PFS signals in maturing datasets .