Executive Summary

Q2 2022 delivered operational execution with first-patient enrollment in Phase 2 trials for mivavotinib (DLBCL) and sapanisertib (NRF2-mutated sqNSCLC) and continued progress in the VPS4 synthetic lethality program; cash runway guided through Q2 2023 .
Financially, net loss narrowed to $9.08M on lower R&D/G&A and a positive warrant-liability fair value change; no revenue recognized, limiting margin analysis .
Guidance was maintained: data readouts for both Phase 2 programs by Q1 2023; VPS4 program update by YE 2022; cash runway through Q2 2023 .
Wall Street consensus estimates via S&P Global were unavailable for CALA this quarter; therefore, no beat/miss assessment versus estimates can be provided (S&P Global consensus unavailable).

What Went Well and What Went Wrong

What Went Well

Initiated Phase 2 enrollment for mivavotinib in non-GCB DLBCL and sapanisertib in NRF2-mutant sqNSCLC as planned; CEO: “We continue to deliver… successfully initiating two new clinical trials… [and] share data… by the first quarter of 2023” .
Encouraging external data: investigator-led sapanisertib + telaglenastat combo showed tolerability and early clinical benefit, including a partial response in NRF2-mutant sqNSCLC .
Cost discipline and non-cash warrant liability revaluation reduced net loss; CFO highlighted R&D down to $7.8M and other income of $2.3M driven by warrant liability fair value change .

What Went Wrong

No revenue recognized in Q2 2022 (vs $3.0M license revenue in Q2 2021), limiting near-term financial flexibility and obviating margin analysis .
Cash declined to $41.8M at quarter-end from $44.7M in Q1 and $59.5M at 12/31/21, reflecting ongoing burn despite runway guided through Q2 2023 .
Estimates context unavailable from S&P Global; investors lack a consensus benchmark for EPS/revenue comparison this quarter (S&P Global consensus unavailable).

Financial Results

P&L and Revenue Comparison

Metric	Q2 2021	Q1 2022	Q2 2022
Revenue ($USD Millions)	$3.00	$0.00	$0.00
Total Operating Expenses ($USD Millions)	$17.31	$13.83	$11.38
Net Loss ($USD Millions)	$14.31	$13.84	$9.08

Notes: Revenue for Q1/Q2 2022 was zero, consistent with the six-month 2022 revenue being “—” and the Q2 2022 quarter showing “—” .

EPS

Metric	Q2 2021	Q1 2022	Q2 2022
EPS (Basic/Diluted, $USD)	N/A	$(0.18)	N/A

EPS for Q2 2022 was not disclosed in the press release; S&P Global consensus unavailable for CALA, so estimates and actual EPS comparison cannot be provided (S&P Global consensus unavailable).

Margins

Metric	Q2 2021	Q1 2022	Q2 2022
Net Income Margin %	—	NM (zero revenue)	NM (zero revenue)

NM = Not meaningful due to zero revenue.

Operating Expense Detail and Other Income

Metric	Q2 2021	Q1 2022	Q2 2022
R&D Expense ($USD Millions)	$12.82	$9.57	$7.76
G&A Expense ($USD Millions)	$4.49	$4.26	$3.62
Other Income (Net) ($USD Millions)	$(0.00) (−$0.004M)	$(0.01)	$2.30

Balance Sheet KPIs

Metric	Dec 31, 2021	Mar 31, 2022	Jun 30, 2022
Cash & Equivalents ($USD Millions)	$59.54	$44.66	$41.79
Working Capital ($USD Millions)	$47.45	$35.89	$33.93
Total Assets ($USD Millions)	$64.76	$50.24	$45.56
Total Liabilities ($USD Millions)	$15.67	$12.67	$10.31
Stockholders’ Equity ($USD Millions)	$8.38	$(3.14)	$35.25

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Phase 2 data readouts (mivavotinib, sapanisertib)	Q1 2023	“Expect to share data… by the first quarter of 2023” (Q1 release)	“Plan to share data… by the first quarter of 2023”	Maintained
VPS4 program update	2022 YE	Initial VPS4A data at AACR and advancing through lead optimization (Q1 release)	“Provide an update… by the end of 2022”	Clarified timing (maintained progress)
Cash runway	Through Q2 2023	“Sufficient… through the second quarter of 2023”	“Sufficient… through the second quarter of 2023”	Maintained
Enrollment start (mivavotinib)	Q2 2022	“On track to begin enrolling in Q2 2022”	First patient enrolled (June 2022)	Achieved
Enrollment start (sapanisertib)	Q2–Q3 2022	“On track to begin enrolling in Q2 2022”	First patient enrolled (July 2022)	Achieved

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2021 & Q1 2022)	Current Period (Q2 2022)	Trend
Mivavotinib Phase 2 in non-GCB DLBCL	Plan to initiate in H1 2022; target biomarker-defined subsets; potential accelerated pathway	First patient enrolled; study aims to confirm single-agent activity and refine dose; ORR and safety primary endpoints	On track; execution milestone achieved
Sapanisertib Phase 2 in NRF2-mutant sqNSCLC	Plan to initiate in H1 2022; selective activity expected; potential registrational path post-Phase 2A	First patient enrolled; dosing rationale discussed; primary endpoints ORR/safety	On track; dosing strategy articulated
Sapanisertib + telaglenastat combo (investigator-led)	Telaglenastat not being developed by CALA; KEAPSAKE discontinued	Favorable tolerability; partial response in NRF2-mutant sqNSCLC; stable disease in KEAP1/NRF2/KRAS	Supportive external validation; combo optionality
VPS4 synthetic lethality program	First data showcased; advancing lead optimization	Advancing multiple series; update by YE 2022	Steady R&D progress
Financing/cash runway	$10M raise in April; runway through Q2 2023	$41.8M cash; runway reiterated through Q2 2023	Runway maintained; cash burn ongoing
Portfolio focus	CB-280 deprioritized; oncology focus	Focus reaffirmed; resource optimization emphasized	Strategy consistent

Management Commentary

CEO (prepared): “We continue to deliver on our commitment to efficiently advance our clinical programs… We look forward to sharing data from the ongoing mivavotinib and sapanisertib phase 2 trials by the first quarter of 2023” .
CMO (prepared): “The recommended Phase 2 dose of 100 mg QD showed a compelling overall response rate of 53% with a median duration of response of 15.7 months in non-GCB patients” (prior analyses cited as rationale) .
CFO (prepared): “Cash and cash equivalents totaled $41.8 million… which we expect will be sufficient to meet our operating plans through the second quarter of 2023” .
CEO (prepared): “We have continued to advance our pipeline of synthetic lethality targets, most notably VPS4A and VPS4B… we expect to provide further updates… by year-end” .

Q&A Highlights

Sapanisertib dosing rationale: PK/PD modeling supports 3 mg QD or 2 mg BID to manage GI toxicities and maximize exposure; combination starting dose at 2 mg QD with telaglenastat is not directly extrapolable to monotherapy .
Combo implications: Early tolerability and efficacy signals (partial response) in NRF2-mutant sqNSCLC are encouraging; combo data complements monotherapy development paths .
Enrollment and timelines: Sites active; patients screened/enrolled; company remains confident in data readouts by Q1 2023 given quick response profiles and open-label designs .
Go/no-go criteria: Company expects meaningful response data by Q1 2023 in biomarker-defined populations with prior single-agent activity; specific thresholds not disclosed .
Cash runway flexibility: Management evaluating runway continuously and will update as plans evolve; focus remains on executing current programs .

Estimates Context

Wall Street consensus (S&P Global) for Q2 2022 revenue and EPS was unavailable for CALA due to missing CIQ mapping; therefore, no comparison versus consensus can be provided this quarter (S&P Global consensus unavailable).

Key Takeaways for Investors

Execution risk reduced: First-patient enrollment achieved in both Phase 2 programs, maintaining the Q1 2023 data catalyst timeline—key near-term stock drivers .
Cost discipline supportive: Lower R&D/G&A and warrant liability revaluation narrowed net loss; however, cash declined to $41.8M, reinforcing the importance of upcoming data to support financing optionality .
Clinical upside: Prior mivavotinib signal (53% ORR in non-GCB DLBCL) and emerging sapanisertib biology in NRF2-mutant tumors frame attractive registrational paths if Phase 2A confirms activity .
Combo optionality: Investigator-led sapanisertib + telaglenastat data provide external validation and potential future combination routes without near-term internal spend .
Watch runway and milestones: Runway through Q2 2023 aligns with Phase 2A readouts; positive efficacy could enable accelerated pathways and unlock financing/partnering .
No revenue and estimates gap: Zero revenue limits near-term P&L leverage; with S&P consensus unavailable, investors should anchor expectations on operational milestones rather than earnings metrics .
Trading implications: Into Q1 2023, sentiment likely hinges on enrollment pace updates and any interim signals; binary response endpoints mean early efficacy reads can move the stock materially .

Calithera Biosciences, Inc. (CALA)·Q2 2022 Earnings Summary