Executive Summary

Q2 2023 delivered disciplined cost control and clinical progress: R&D fell to $10.836M (from $15.164M YoY), G&A held flat at $3.055M, and net loss narrowed to $16.235M ($2.00 EPS) versus $19.099M ($2.50 EPS) in Q2 2022 .
Cash, cash equivalents and restricted cash dropped to $16.1M from $58.8M in Q1 and $76.7M at YE22, primarily due to the April repayment of the Runway term loan; management expects a strategic manufacturing transaction to reduce annualized operating and interest expense by at least $28M, extending cash runway .
MB-106 advanced across WM and FL cohorts; favorable response rates and manageable safety reinforce potential for an outpatient CAR-T option; management reiterated plans to initiate a pivotal Phase 2 in WM potentially in Q1 2024 and at least one additional B‑cell malignancy later in 2024 .
Street consensus (S&P Global) for Q2 2023 EPS/revenue was unavailable at time of query; beats/misses vs estimates cannot be assessed at this time (consensus unavailable via S&P Global).

What Went Well and What Went Wrong

What Went Well

MB-106 clinical momentum: In WM (6 patients, all BTKi‑experienced), 83% overall response with 2 CRs and no grade ≥3 CRS/ICANS; one CR durable for 22 months, with normalized IgM and no additional therapy initiated .
FL cohort efficacy: ORR 95% (19/20) and CR 80% (16/20), with 100% ORR and 91% CR at higher dose levels; all CRS events grade 1–2 and no ICANS observed .
Strategic opex actions: uBriGene partnership expected to reduce annualized operating and interest expense by at least $28M, providing manufacturing support while focusing resources on data readouts and registration strategy .
Management quote: “Manufacturing support from uBriGene… allows us to significantly reduce annualized operating and interest expense by at least $28 million to ensure focus on data readouts for key programs and extend our cash runway.” – Manuel Litchman, M.D., CEO .

What Went Wrong

Cash drawdown: Cash and restricted cash fell to $16.1M from $58.8M in Q1 and $76.7M at YE22, largely reflecting $30.7M loan payoff in April; near‑term financing dependency increases execution risk .
Limited revenue visibility: As a clinical-stage biotech, results were driven by opex; no product revenue to offset burn, keeping reliance on external capital sources .
Manufacturing lease transfer contingencies: $5M contingent consideration from uBriGene depends on landlord consent and Mustang raising $10M in equity; until transfer, Mustang retains lease and personnel, sustaining some fixed costs .

Financial Results

P&L Comparison (USD Millions unless noted)

Metric	Q2 2022	Q1 2023	Q2 2023
Research & Development ($)	$15.164	$14.000	$10.836
General & Administrative ($)	$3.077	$2.321	$3.055
Total Operating Expenses ($)	$18.241	$16.321	$13.891
Net Loss ($)	$19.099	$16.693	$16.235
Diluted EPS ($)	$2.50	$2.06	$2.00

Cash and Liquidity KPIs

Metric	YE 2022	Q1 2023	Q2 2023
Cash, Cash Equivalents & Restricted Cash ($)	$76.7	$58.8	$16.1
Notes Payable, Long-Term, Net ($)	$27.436	$27.579	$0.000 (repaid in April 2023)

Notes: Q2 cash decline primarily reflects Runway term loan repayment in April 2023 .

Revenue and Margins

Metric	Q2 2022	Q1 2023	Q2 2023
Product/License Revenue ($)	N/A (not disclosed)	N/A (not disclosed)	N/A (not disclosed)
Gross Margin (%)	N/A	N/A	N/A

No revenue was disclosed in the company’s press release financial statements; margin metrics are not applicable for the period .

EPS vs Estimates

Metric	Q2 2022	Q1 2023	Q2 2023	Consensus EPS
Diluted EPS ($)	$2.50	$2.06	$2.00	N/A*

*Consensus estimates unavailable via S&P Global at time of query.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
MB-106 WM pivotal Phase 2 start	Q1 2024 target	“First pivotal Phase 2 WM patient potentially to be treated in Q1 2024”	“First pivotal Phase 2 patient with WM potentially in Q1 2024”	Maintained
MB-106 multicenter dose escalation	Phase 1 indolent arm	“Final dose level escalation anticipated in Q3 2023”	“Anticipates escalation to the final dose level in Q3 2023”	Maintained
MB-106 data disclosures	2023	“Safety/efficacy data in Q2 2023; initial multicenter data shortly”	“Initial data soon; more extensive multicenter data later this year; additional data in Q4”	Timing updated/expanded
In vivo CAR‑T platform (Mayo)	2023	“POC publication in murine model in 2023”	“Anticipates POC publication in 2023”	Maintained
Operating + Interest expense run‑rate	Annualized	Not previously quantified	“Reduce by at least $28M annualized”	New
Manufacturing facility transaction	2023	N/A	Closed July 2023: $6M upfront; $5M contingent on $10M equity raise and lease assignment within 2 years	New strategic transaction

Earnings Call Themes & Trends

(Transcript not located; themes derived from press releases and 8‑K exhibits)

Topic	Previous Mentions (Q4 2022 and Q1 2023)	Current Period (Q2 2023)	Trend
R&D execution (MB-106)	ORR 96%/CR 75% across B‑NHL/CLL (Fred Hutch); multicenter trial accruing; dose escalation planned	WM cohort 83% ORR; FL cohort 95% ORR/80% CR; multicenter dose escalation to final level in Q3 2023	Positive, consistent efficacy and manageable safety
Regulatory/registration (WM)	Orphan Drug for WM; accelerated Phase 2 registration strategy; pivotal WM patient potentially Q1 2024	Reiterated accelerated Phase 2 strategy; WM pivotal patient potentially Q1 2024	Maintained path to registration
Manufacturing strategy	Debt financing (Runway) in 2022; no manufacturing divestiture	uBriGene partnership; $6M upfront, $5M contingent; expected opex/interest reduction ≥$28M	Strategic outsourcing/cost optimization
Financing/debt	$75M debt facility in 2022	Terminated Runway Agreement; $30.7M payoff received by lender in April	Deleveraging and balance sheet reset
Pipeline breadth	Broad B‑cell malignancy coverage; multicenter trial accrual	Plan to initiate pivotal Phase 2 in at least one additional B‑cell malignancy later in 2024	Expanding registrational footprint

Management Commentary

“MB‑106 has the potential to fill a significant unmet need in many difficult‑to‑treat cancers including Waldenstrom macroglobulinemia (‘WM’), as there are currently no CAR T treatments for WM approved by the U.S. Food and Drug Administration (‘FDA’). We anticipate the results from our multicenter Phase 1 indolent lymphoma arm… to support an accelerated Phase 2 registration strategy for WM, with the first pivotal Phase 2 patient with WM to be treated potentially in the first quarter of 2024.” – Manuel Litchman, M.D., CEO .
“Manufacturing support from uBriGene… allows us to significantly reduce annualized operating and interest expense by at least $28 million to ensure focus on data readouts for key programs and extend our cash runway.” – Manuel Litchman, M.D., CEO .

Q&A Highlights

No earnings call transcript available in the document set for Q2 2023; Q&A highlights cannot be provided this quarter.

Estimates Context

S&P Global Wall Street consensus for Q2 2023 EPS and revenue was unavailable at time of query; therefore, we cannot assess beats/misses or estimate variances for MBIO. If and when available, comparisons should anchor to S&P Global consensus for EPS and any revenue/gross margin expectations.
Given the lack of revenue disclosure and clinical-stage status, consensus typically centers on EPS loss trajectory and cash runway; opex/interest reduction of ≥$28M and the loan payoff are likely inputs to forward estimate revisions .

Key Takeaways for Investors

Cost discipline is materializing: total opex fell sequentially and YoY, and management targets ≥$28M annualized opex/interest reduction via uBriGene, a meaningful lever to extend runway and reduce financing risk .
Clinical de‑risking continued: WM cohort 83% ORR with durable CRs and manageable safety; FL cohort shows strong CR rates at higher dose levels, supporting an outpatient therapy profile .
Registration timeline intact: WM pivotal Phase 2 could start in Q1 2024; an additional B‑cell malignancy pivotal program is planned later in 2024, providing potential value‑inflection catalysts .
Balance sheet reset: cash fell to $16.1M largely due to Runway loan repayment; near‑term execution on milestones and potential equity financing remain important (with a $5M contingent payment tied to lease transfer and equity raise) .
Manufacturing transition risk is manageable: until lease transfer, Mustang retains facility and personnel and continues MB‑106 manufacturing, mitigating near‑term supply risk while pursuing transfer approvals .
Trading lens: Near‑term catalysts include multicenter MB‑106 data updates later in 2023 and confirmation of pivotal start timelines; watch for financing updates and lease assignment progress as stock drivers .

Appendix: Additional Data

Clinical Data Highlights (WM and FL)

WM cohort (Fred Hutch): 5/6 responders (2 CR, 1 VGPR, 1 PR, 1 minor); 1 SD; CRS grade 1–2; single grade 1 ICANS; no grade ≥3 events; one CR in remission 22 months with normalized IgM .
FL cohort (Fred Hutch): ORR 95%, CR 80%; higher dose levels achieved ORR 100% and CR 91%; all CRS grade 1–2; no ICANS .

Transaction Details (uBriGene)

Upfront $6M at closing; additional $5M contingent upon $10M equity raise and lease assignment within two years; Mustang retains lease/personnel and continues MB‑106 manufacturing until transfer .

Footnote: Consensus estimates were unavailable via S&P Global at time of query; any future estimate comparisons should be sourced from S&P Global.

MUSTANG BIO, INC. (MBIO)·Q2 2023 Earnings Summary