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Calithera Biosciences, Inc. (CALA)·Q1 2022 Earnings Summary

Executive Summary

  • Q1 2022 was pre‑revenue with disciplined spend: total operating expenses fell 33% YoY to $13.8M; net loss was $13.8M (EPS −$0.18). Cash and cash equivalents were $44.7M, with runway guided through Q2 2023 .
  • Clinical execution on track: first patients for mivavotinib (DLBCL) and sapanisertib (sqNSCLC) trials expected to enroll in Q2 2022; initial data targeted by Q1 2023 .
  • Portfolio focus sharpened: company presented first data from internally‑discovered VPS4A synthetic lethality inhibitors; decided not to pursue CB‑280 in CF near‑term; partnering optionality remains .
  • Liquidity risk noted: 10‑Q includes going concern language and outlines potential mitigants (financing, spend reductions, collaborations) .
  • Near‑term stock catalysts: trial initiations (Q2 2022), possible ASCO combination data (legacy mivavotinib study), and steady cadence toward Q1 2023 readouts .

What Went Well and What Went Wrong

What Went Well

  • Timely transfer and site start‑up for Takeda assets; management reaffirmed Q2 2022 first‑patient‑in and Q1 2023 data timeline: “We are on track to begin enrolling patients…expect to share data…by the first quarter of 2023” .
  • Synthetic lethality progress: first data on VPS4A inhibitors presented at AACR; management believes these are the first active, on‑target VPS4 inhibitors described to date .
  • Balance sheet strengthened: April 1, 2022 underwritten offering raised $10.0M gross ($8.5M net); guided runway through Q2 2023 .

What Went Wrong

  • No revenue in the quarter and continued losses: net loss −$13.8M; EPS −$0.18 .
  • Going concern disclosure: management concluded substantial doubt exists without additional funding; mitigants may be less than probable at issuance date .
  • CF program deprioritization: decision not to pursue CB‑280 in CF due to shifting therapeutic/regulatory landscape; potential to partner remains, but timing uncertain .

Financial Results

MetricQ1 2021Q3 2021Q4 2021Q1 2022
Revenue ($USD Millions)$0.0 $6.8 $0.0 $0.0
Net Loss ($USD Millions)$(20.4) $(11.2) $(69.2) $(13.8)
EPS (basic & diluted, $USD)$(0.28) $(0.15) $(0.92) $(0.18)
R&D Expense ($USD Millions)$15.3 $11.6 $13.7 $9.6
G&A Expense ($USD Millions)$5.4 $6.3 $4.6 $4.3
Total Operating Expenses ($USD Millions)$20.8 $17.9 $69.2 $13.8
Net Income Margin %N/A (no revenue) N/A (license one‑off; not meaningful) N/A (no revenue) N/A (no revenue)

R&D program spending detail (quarterly):

Development CandidateQ1 2021 ($USD Millions)Q1 2022 ($USD Millions)
Sapanisertib (CB‑228)$0.0 $2.3
Mivavotinib (CB‑659)$0.0 $2.0
Telaglenastat (CB‑839)$11.7 $2.3
CB‑280$1.8 $0.8
Preclinical & Research$1.9 $2.2
Total R&D$15.3 $9.6

KPIs (balance sheet snapshot):

KPIQ3 2021Q4 2021Q1 2022
Cash & Cash Equivalents ($USD Millions)$84.5 $59.5 $44.7
Working Capital ($USD Millions)$72.8 $47.4 $35.9
Total Assets ($USD Millions)$90.0 $64.8 $50.2
Total Liabilities ($USD Millions)$15.6 $15.7 $12.7
Stockholders’ Equity ($USD Millions)$74.4 $8.4 $(3.1)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough Q2 2023“Sufficient…through the second quarter of 2023” (12/31/21) “Sufficient…through the second quarter of 2023” (3/31/22 base + 4/1 offering) Maintained
Mivavotinib Phase 2 FPIQ2 2022Initiate Phase 2 in H1 2022 “Anticipates the first patient enrolled in the second quarter of 2022” Narrowed to Q2; on track
Sapanisertib Phase 2 FPIQ2 2022Initiate Phase 2 in H1 2022 “Anticipates the first patient enrolled…in the second quarter of 2022” Narrowed to Q2; on track
Initial data readoutsQ1 2023“Plan to share data…by the first quarter of 2023” “Expect to share data…by the first quarter of 2023” Maintained

Earnings Call Themes & Trends

TopicQ3 2021 (Nov-21)Q4 2021 (Apr-22)Q1 2022 (May-22)Trend
Clinical execution for mivavotinib/sapanisertibAnnounced asset acquisition; Phase 2 starts planned Q1 2022 Site activation well underway; data guided for Q1 2023 FPI Q2 2022; data Q1 2023; open-label ORR endpoints Consistent on timing; increasing operational detail
Synthetic lethality (VPS4A/B)Discovery focus; paralog strategy described AACR poster planned; advancing lead optimization Presented first VPS4A inhibitor data; lead optimization ongoing Momentum building; external validation via AACR
CF program (CB‑280)Encouraging Phase 1b interim data; dose escalation ongoing Cohorts complete; next steps under evaluation Decision not to pursue CF now; rationale tied to landscape shifts Strategy pivot; resource focus on oncology
Funding/runwayCash/investments $84.5M; into 2023 $59.5M + offering; run through Q2 2023 $44.7M cash; offering closed; Q2 2023 runway Runway reiterated amid lower cash balance
Regulatory/commercialTelaglenastat discontinued; pipeline reorientation Registration‑enabling Phase 2b possible Registration intent reiterated for biomarker subsets Clear path toward potential accelerated approvals

Management Commentary

  • CEO on execution and timelines: “We are on track to begin enrolling patients in both mivavotinib and sapanisertib trials in the second quarter of 2022 and expect to share data…by the first quarter of 2023” .
  • CEO on synthetic lethality program: “Presented the first data from our internally‑discovered…VPS4A inhibitors…first active, on‑target VPS4 inhibitors described to date” .
  • CMO on trial design: “Open‑label response rate endpoint studies…responses tend to happen very quickly…expect to…generate data in Q1 ’23” .
  • CFO on liquidity: “Cash and cash equivalent totals $44.7 million…together with proceeds…sufficient to meet our operating plan through the second quarter of 2023” .

Q&A Highlights

  • Trial initiation and enrollment logistics: Sites actively opening; FPI in H1’22 (clarified to Q2’22 on prepared remarks); binary efficacy signals expected to read quickly .
  • Antengene CD73 partnership: $3M upfront received; up to $252M milestones; no near‑term milestone guidance provided .
  • Portfolio prioritization: CB‑280 pause driven by highly effective modulators (e.g., Trikafta) reshaping CF unmet need and regulatory endpoints; openness to future partnership .
  • Resource allocation and runway: Cash through H1’23; expect Phase 2 data in Q1’23 before needing any potential market financing .
  • Asset prioritization: No intent to out‑license one of the two Takeda assets; both viewed as high value with strong potential .

Estimates Context

  • Wall Street consensus (S&P Global) for Q1 2022 EPS and revenue was unavailable due to missing mapping for CALA in the SPGI/Capital IQ dataset, so comparisons to consensus could not be performed. Values unavailable via S&P Global.

Key Takeaways for Investors

  • Execution risk appears contained: both Phase 2 programs now at site start‑up with Q2 2022 FPI and Q1 2023 data guiding the stock’s near‑term narrative .
  • Focused R&D spend: YoY R&D down 38% as telaglenastat wind‑down freed resources for mivavotinib and sapanisertib; preclinical spend modestly up to support VPS4A .
  • Liquidity watch: runway through Q2 2023 and going concern disclosure emphasize need for timely data and potential financing; monitor dilution and milestone receipts .
  • Potential registration paths: biomarker‑enriched designs (ABC DLBCL with MYD88/CD79b; NRF2‑mutated sqNSCLC) could enable accelerated approvals upon compelling ORR .
  • Catalysts/tactical trading: trial initiations (Q2), AACR/VPS4 follow‑ups, potential ASCO legacy combo data for mivavotinib, and intra‑quarter clinical updates may drive sentiment before Q1 2023 readouts .
  • Partnering optionality: CB‑280 deprioritized; Antengene CD73 program advancing; watch for business development to extend runway or de‑risk assets .
  • Risk framing: single‑segment, pre‑revenue biotech with delisting risk previously disclosed and substantial doubt language; position sizing should reflect financing and execution uncertainties .