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RAPT Therapeutics, Inc. (RAPT)·Q1 2024 Earnings Summary

Executive Summary

  • RAPT reported Q1 2024 net loss of $30.5M and EPS of -$0.79, with total operating expenses of $32.5M and no product revenue as the company remains in clinical stage . As of March 31, cash and marketable securities were $141.6M .
  • The FDA placed clinical holds in February on Phase 2b AD and Phase 2a asthma trials of zelnecirnon; management decided to close and unblind both trials to inform the path forward with the FDA, with analysis targeted for Q3 2024 .
  • R&D expense declined year over year (-3% to $24.8M) on lower program costs, while G&A rose to $7.7M on higher personnel/stock comp and consulting/facilities .
  • Oncology program (tivumecirnon + pembrolizumab) delivered CPI-experienced HNSCC data in April: confirmed responses in 5/32 (15.6%); ORR 17.4% in PD-L1+ and 22.2% in HPV+ subsets, supporting continued development .
  • Wall Street consensus from S&P Global was unavailable at the time of this analysis; estimate comparisons are therefore not included (S&P Global data unavailable).

What Went Well and What Went Wrong

What Went Well

  • Maintained $141.6M in cash and marketable securities, supporting at least 12 months of operations; executed $9.0M ATM equity sales (365,316 shares) to bolster liquidity .
  • R&D expenses fell year over year (-$0.8M) driven by lower zelnecirnon, tivumecirnon and early-stage program costs, partially offset by personnel/stock comp increases .
  • Oncology program update: CPI-experienced HNSCC cohort showed 15.6% confirmed responses (5/32); PD-L1+ ORR 17.4% (4/23), HPV+ ORR 22.2% (4/18), an encouraging signal for tivumecirnon combinations .
    Quote: “In the 23 patients known to have PD-L1+ disease... ORR of 17.4%... in 18 patients... HPV+ disease, ORR of 22.2%” .

What Went Wrong

  • Clinical hold on zelnecirnon in AD and asthma due to a serious adverse event of liver failure requiring transplant, halting dosing/enrollment; decision to close and unblind both trials reflects significant setback in the AD/asthma programs .
  • Net loss widened modestly (+$1.3M YoY) to $30.5M; G&A increased by $1.7M YoY on higher personnel, stock comp, consulting and facilities costs .
  • No revenue generated as the company remains pre-commercial, limiting margin visibility and estimate comparability .

Financial Results

MetricQ3 2023Q4 2023Q1 2024
Revenue ($USD Millions)$0.00 $0.00 $0.00
Net Loss ($USD Millions)$(31.37) $(30.88) $(30.52)
EPS ($USD)$(0.82) $(0.80) $(0.79)
Total Operating Expenses ($USD Millions)$33.92 $33.22 $32.52
Cash & Marketable Securities ($USD Millions)$184.8 $158.9 $141.6

Notes:

  • RAPT reported no product revenue in these periods (clinical-stage) .
  • Estimates from S&P Global were unavailable at time of analysis; estimate comparisons are therefore omitted.

Segment breakdown: Not applicable (no commercial segments) .

KPIs

KPIQ3 2023Q4 2023Q1 2024
AD Phase 2b Enrolled (patients)——229
AD Phase 2b Completed 16-week dosing (patients)——~110
ATM Shares Sold (shares)——365,316
ATM Net Proceeds ($USD Millions)——$9.0
Cash Runway Disclosure“Through mid-2025” expectation —“At least 12 months from filing date”

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Zelnecirnon AD & asthma trial status2024Working to lift clinical hold Close and unblind both trials; analyze data by Q3 2024 Lowered (program pause/closure)
Cash runwayForward 12 months“Through mid-2025” expectation (Q3 press release commentary) “Sufficient funds for at least 12 months from 10-Q filing date” Maintained (near-term solvency)

No revenue/OpEx/EBITDA/tax guidance was provided in Q1 materials .

Earnings Call Themes & Trends

(Transcript not available in the document corpus; themes derived from press releases/10-Q.)

TopicPrevious Mentions (Q-2: Q3 2023)Previous Mentions (Q-1: Q4 2023)Current Period (Q1 2024)Trend
Clinical hold / patient safetyNo hold; progress in AD/asthma enrollment; mid-2024 AD topline anticipated Working diligently to lift clinical hold after SAE Close/unblind AD & asthma; analyze data Q3; investigating SAE Deteriorated (program paused)
Oncology program (tivumecirnon)Progress; NSCLC data at SITC Ongoing; AACR update planned HNSCC CPI-experienced ORR data disclosed Improving evidence base
Liquidity/runwayStrong cash ($184.8M); runway through mid-2025 Cash $158.9M Cash/marketable $141.6M; at least 12 months runway Declining balance; runway maintained near term
R&D/OpEx disciplineHigher R&D YoY on zelnecirnon costs Elevated R&D and G&A R&D down YoY; G&A up Mixed (R&D easing, G&A up)
Regulatory/legalStandard forward-looking risk Focus on lifting clinical hold Risks emphasize clinical holds, safety investigation -Heightened regulatory risk

Management Commentary

  • “Although there were a significant number of patients who were unable to complete the AD trial due to the hold, we believe we will have sufficient data, even if not statistically significant, to inform our path forward and support our discussions with the FDA… we anticipate that our analysis of the data will be completed in the third quarter of this year.” — Brian Wong, President & CEO (Q1 press release) .
  • “We are working diligently to lift the clinical hold on our Phase 2 trials of zelnecirnon in atopic dermatitis and asthma. Patient safety is our top priority.” — Brian Wong (Q4 press release) .

Q&A Highlights

  • A Q1 2024 earnings call transcript was not available in the document corpus; management themes and clarifications derive from the Q1 press release and 10-Q filing . No specific Q&A content to report.

Estimates Context

  • S&P Global consensus estimates were unavailable at the time of analysis; as a result, we are unable to provide versus-consensus comparisons in this recap. Values retrieved from S&P Global were unavailable due to access limits.

Where third-party outlets noted EPS comparisons (e.g., -$0.79 EPS vs -$0.81), we have not incorporated them, as our standard is to anchor to S&P Global consensus; thus estimate-driven beat/miss assessments are omitted pending access to SPGI data .

Key Takeaways for Investors

  • Near-term catalyst: unblinded AD/asthma data analysis expected in Q3 2024 to inform FDA dialogue and future development of zelnecirnon; this will be pivotal for the inflammation franchise .
  • Clinical risk elevated: SAE-triggered clinical holds and program closure/unblinding introduce uncertainty around zelnecirnon’s safety profile and the feasibility of resuming trials -.
  • Oncology optionality: Tivumecirnon combination data in CPI-experienced HNSCC demonstrate ORR signals that could support continued investment or partnering discussions in oncology .
  • Liquidity adequate but declining: $141.6M in cash/marketable securities and an ATM program ($140.6M capacity remaining as of Q1) provide at least 12 months’ runway; monitor cash burn and any further ATM usage .
  • Expense trajectory: R&D down YoY as programs shift; G&A up on personnel and stock comp—watch for further cost discipline amid pipeline transitions .
  • Stock reaction can be sensitive to regulatory updates; anticipate volatility around Q3 data analysis timing and any FDA communications -.

Sources: Q1 2024 8-K press release and exhibits ; Q1 2024 10-Q -; Q4 2023 8-K press release ; Q3 2023 8-K press release ; Feb 20/22, 2024 8-Ks on clinical hold ; RAPT investor site press release page .