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BriaCell Therapeutics Corp. (BCTX)·Q4 2022 Earnings Summary

Executive Summary

  • Pre-revenue quarter with focus on clinical execution; no product revenue was reported. FY 2022 ended with $41.0M cash to fund trials, providing liquidity into FY 2023 while operating losses reflect R&D scale-up and warrant-liability remeasurement effects .
  • Clinical catalysts advanced during and immediately after Q4: completion of Phase I safety for Bria-IMT + retifanlimab and transition to randomized Phase II (FDA Fast Track), plus a planned FDA meeting on pivotal design .
  • Early efficacy and quality-of-life signals were highlighted: 70% of evaluable patients showed disease control or PFS benefits vs their last therapy in a 12-patient cohort at SITC; SABCS posters emphasized improved QoL (“better quality of life,” “less pain”), and an HR+/grade I/II subset (CBR 63%, ORR 25%) suggesting a responsive population .
  • Strategic expansion: exclusive license to develop soluble CD80 (sCD80) (2% royalty to UMBC), molecular-profiling enrollment partnership with Caris Life Sciences, and an AI-enabled antibody discovery collaboration with IPA’s BioStrand (success-based milestones/royalties), broadening optionality beyond Bria-IMT .

What Went Well and What Went Wrong

What Went Well

  • Completed Phase I safety/tolerability for Bria-IMT + retifanlimab in 12 subjects; randomized Phase II efficacy evaluation (Fast Track) is underway, with dosing-schedule arm added and a planned FDA meeting on registration study design. “We are very impressed by the clinical data showing a favorable safety profile...” (Dr. Del Priore) .
  • Positive efficacy/QoL signals: SITC update showed 70% of evaluable patients with disease control or PFS benefits vs prior therapy; SABCS posters cited “better quality of life” and “less pain” for many patients, with safety described as “well-tolerated with no dose-limiting toxicities.” Dr. Chumsri: Bria-IMT “responses across all MBC subtypes and a very manageable adverse event experience” .
  • Identification of responsive subgroups: HR+/grade I/II patients showed CBR 63%, ORR 25%, PFS 5.8±2.9 mos; responses observed with both pembrolizumab and retifanlimab combinations, supporting additive/synergistic PD-1 effects .

What Went Wrong

  • Operating expenses rose with trial expansion: FY22 R&D $8.02M (vs. $2.02M FY21) and G&A $7.27M (vs. $4.96M), increasing operating loss as the company scaled programs .
  • Non-cash warrant-liability volatility created large swings in reported results (FY22 financial expense, net $(11.55)M; prior-year also significant), and contributed to outsized quarterly loss in the restated FY22 Q1 comparison (warrant revaluation loss of $(25.25)M) .
  • Controls: management reported material weaknesses in internal control over financial reporting as of Oct 31, 2022, and is implementing remediation (additional personnel, segregation of duties, documentation) .

Financial Results

Fiscal year view (context for Q4 FY2022)

MetricFY 2021FY 2022
Revenues ($)$0 $0
R&D Expense ($)$2,020,899 $8,021,489
G&A Expense ($)$4,955,136 $7,267,452
Operating Loss ($)$(6,976,035) $(15,288,941)
Financial Expenses, net ($)$(6,840,165) $(11,549,962)
Net Loss ($)$(13,816,200) $(26,838,903)
EPS (Basic & Diluted) ($)$(3.06) $(1.73)
Cash & Equivalents (period-end) ($)$57,268,685 $41,041,652

Notes:

  • FY 2022 (ended July 31, 2022) provides the context for Q4 FY2022; BriaCell is pre-revenue .

Subsequent quarter (Q1 FY2023) vs prior-year quarter (YoY lens on operating trajectory post-Q4)

MetricQ1 FY2022 (3 mo ended Oct 31, 2021)Q1 FY2023 (3 mo ended Oct 31, 2022)
Revenues ($)$0 $0
R&D Expense ($)$875,636 $3,255,215
G&A Expense ($)$1,409,173 $2,147,936
Total Operating Expenses ($)$2,284,809 $5,403,151
Financial Income (Expenses), net ($)$(25,248,676) $4,296,610
Net Income (Loss) ($)$(27,533,485) $(1,106,541)
EPS (Basic & Diluted) ($)$(1.81) $(0.07)
Cash from Operations ($)$(1,778,599) $(3,542,382)
Cash & Equivalents (period-end) ($)$55,490,086 $37,451,976

Drivers:

  • Operating spend increased as trials scaled; financial line benefited from a favorable warrant-liability revaluation in Q1 FY2023 versus a large non-cash loss in the prior-year quarter .

Balance sheet highlights (Q4 FY2022 context)

  • Cash & Equivalents at FY22 year-end: $41.0M, providing runway into FY23 .
  • Warrant liability at FY22 year-end: $31.3M, a source of non-cash P&L volatility .

KPIs (clinical efficacy signals from conference updates)

Cohort/SubsetData Point
SITC 2022 (12-patient retifanlimab cohort)70% of evaluable patients showed either disease control or PFS benefit vs their last therapy; DCR 57% (4/7 evaluable)
SABCS 2022 HR+/Grade I/II subsetCBR 63% (5/8 evaluable), ORR 25%, PFS 5.8 ± 2.9 months
Quality of LifePatients with disease control reported “better quality of life” and “less pain”; treatment well-tolerated with no dose-limiting toxicities

Guidance Changes

Metric/ItemPeriodPrevious GuidanceCurrent GuidanceChange
Clinical Program – Bria-IMT + retifanlimabPhase I → Phase IIPhase I safety/tolerabilityPhase I completed; randomized Phase II efficacy evaluation in progress (Fast Track); added dosing-schedule armRaised program stage; progression to randomized Phase II
Regulatory Interactions2022Not specifiedOn schedule to meet FDA later in 2022 to discuss pivotal designNew milestone outlined
Financial Guidance (revenue, margins, opex, tax, dividends)N/ANoneNoneNo financial guidance provided

Earnings Call Themes & Trends

No Q4 FY2022 earnings call transcript was found; themes derived from company filings and press releases.

TopicPrevious Mentions (Q-2 and Q-1 context)Current Period (Q4 FY2022)Trend
Clinical execution & safetyOngoing Phase I/IIa combo program; Fast Track status cited in updates Phase I safety completed; randomized Phase II underway; dosing-schedule arm added Positive momentum
Efficacy & patient subsetsPrior analyses suggested benefit in grade I/II and HLA-matched patients HR+/grade I/II cohort with CBR 63%, ORR 25%; improved QoL; signals with both pembrolizumab and retifanlimab Sharper patient-selection narrative
Partnerships/enablementNCI collaboration; Incyte combo; imaging biomarker tie-in (ImaginAb) in prior periods Caris Life Sciences (RIT network) for biomarker-driven enrollment; sCD80 license; AI antibody collaboration (BioStrand) Broadened ecosystem
Liquidity/runwayLarge cash balance from 2021 financings; warrant liability volatility FY22 year-end cash $41.0M; continued P&L volatility from warrants Stable liquidity; P&L volatility persists
Controls & governanceMaterial weakness disclosed historically with plans to remediate ICFR material weaknesses remain as of Q1 FY2023; remediation actions in flight Work-in-progress

Management Commentary

  • “We are very impressed by the clinical data showing a favorable safety profile for our treatment in advanced breast cancer patients who have failed other therapies.” – Dr. Giuseppe Del Priore, CMO, on completion of Phase I and progression to randomized Phase II .
  • “We’re delighted that many patients stayed on our study longer than their last therapy, suggesting the Bria-IMT combination regimen is both well tolerated and clinically effective.” – Dr. William V. Williams, President & CEO, on SABCS data .
  • “Bria-IMT does not have any theoretical cross-resistance or overlapping toxicity with other MBC treatments… encouraging to see responses across all MBC subtypes and a very manageable adverse event experience.” – Dr. Saranya Chumsri, Mayo Clinic (PI), SABCS audio summary .

Q&A Highlights

No Q4 FY2022 earnings call transcript was available; no Q&A highlights to report.

Estimates Context

  • Wall Street consensus estimates (S&P Global) were unavailable/not retrievable at the time of analysis; the company is pre-revenue and thinly covered. We attempted to pull quarterly EPS and revenue estimates and hit S&P Global request limits; consensus should be treated as unavailable for this recap.

Key Takeaways for Investors

  • Bria-IMT clinical momentum: safety de-risked with Phase I completion; randomized Phase II underway under Fast Track—key de-risking and value-inflection set-up .
  • Early efficacy/QoL signals and responsive subgroups (HR+/grade I/II) strengthen the biological rationale and potential path to registration in defined populations .
  • Strategic breadth beyond Bria-IMT (sCD80 license; AI-enabled antibody discovery; Caris biomarker network) increases optionality and partnership vectors .
  • Sufficient liquidity to execute near-term milestones (FY22 cash $41.0M); monitor burn versus trial cadence and any business development inflows .
  • Non-cash warrant-liability swings will continue to drive P&L volatility; focus on operating metrics and cash runway rather than GAAP bottom line noise .
  • Controls remediation is in progress; continued improvement in ICFR is an important governance watch item ahead of registrational activities .
  • Near-term trading catalysts: randomized Phase II updates, additional clinical-site activations, FDA feedback on pivotal design, and further efficacy/QoL disclosures at conferences .

Supporting Documents and Press Releases Consulted

  • FY 2022 10-K (financials, liquidity, business overview) .
  • 10-Q for quarter ended Oct 31, 2022 (Q1 FY2023) (operational/financial momentum and controls) .
  • 8-K (Item 2.02) Oct 28, 2022 with restated Q1 FY2022 financials (YoY comparator and warrant impact) .
  • Phase I completion → Phase II progression (press release, Oct 21, 2022) .
  • Caris Life Sciences partnership (Sep 14, 2022) .
  • sCD80 license with UMBC (Aug 4, 2022) (2% royalty; license terms) .
  • Positive initial efficacy at SITC (Nov 10, 2022) .
  • SABCS posters (Dec 8, 2022) (QoL, HR+/grade I/II subset performance, quotes) .
  • AI collaboration with IPA’s BioStrand (Nov 30, 2022) .