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ATHERSYS, INC / NEW (ATHX)·Q2 2022 Earnings Summary

Executive Summary

  • Q2 2022 revenue was $2.316M, with net loss of $23.648M and EPS of $(0.09); total operating expenses rose to $26.574M, reflecting a $4.9M impairment and $1.5M restructuring costs .
  • Management initiated a corporate restructuring (workforce reduction up to 70%) and prioritized the MASTERS-2 ischemic stroke Phase 3 trial; MACOVIA (ARDS) was suspended pending financing/partnership .
  • Clinical execution improved: MASTERS-2 enrollment rate doubled vs prior years and Q2’22 had the highest quarterly enrollments to date; 10 new trial sites added across Germany, UK, Taiwan, and Australia .
  • Consensus estimates from S&P Global were unavailable for ATHX at the time of this analysis due to missing CIQ mapping, so we cannot assess beats/misses; investors will focus on cash runway and financing options given cash fell to $13.4M at quarter-end .

What Went Well and What Went Wrong

What Went Well

  • MASTERS-2 reprioritized; enrollment rate doubled and Q2 delivered the highest quarterly enrollments to date, supported by 10 new global trial sites (Germany, UK, Taiwan, Australia) .
  • Strategic focus sharpened via restructuring to conserve cash and improve execution; management highlighted confidence that actions “better position Athersys in bringing MultiStem to market” .
  • MATRICS-1 trauma study advanced: first cohort enrollment completed and dosing initiated using large-scale bioreactor-derived product, supporting scalability .
  • Management quote: “We are particularly pleased that [TREASURE] demonstrated improvement in other pre-specified measures of functional outcomes over time, supporting the long-term impact of MultiStem in ischemic stroke patients” — Dan Camardo, CEO .

What Went Wrong

  • TREASURE (Japan stroke study by Healios) missed the primary endpoint (Excellent Outcome at 90 days), although longer-term functional measures improved; raises near-term approval uncertainty .
  • MACOVIA (ARDS) suspended to focus resources on MASTERS-2 pending additional financing or partnership, signaling constrained capital and trial prioritization .
  • Operating expense inflation (impairment and restructuring) drove total operating expenses higher QoQ and YoY; net loss widened modestly YoY to $23.648M despite collaboration revenue .
  • Cash declined to $13.378M at June 30, 2022 (from $37.407M at 12/31/21), heightening financing risk and urgency to secure partners/funding .

Financial Results

Consolidated P&L and Liquidity (USD, in millions except per-share)

MetricQ4 2021Q1 2022Q2 2022
Revenues$0.722 $2.912 $2.316
Loss from Operations$(21.675) $(22.378) $(24.258)
Net Loss$(21.711) $(22.216) $(23.648)
EPS (Basic & Diluted)$(0.09) $(0.09) $(0.09)
Total Operating Expenses$22.397 $25.290 $26.574
Cash & Cash Equivalents (period-end)$37.407 $21.797 $13.378

Notes:

  • Q2 2022 R&D included a $4.9M impairment and $1.5M restructuring costs; G&A included $1.2M restructuring costs .
  • Collaboration revenue reflects services provided to Healios and can fluctuate period-to-period .

YoY and QoQ Dynamics (calculated from cited figures)

  • Revenue: +$2.316M YoY (vs $0.000M in Q2 2021 per narrative), and down $0.596M QoQ vs Q1 2022 ($2.912M) .
  • Net Loss: $(23.648)M vs $(22.599)M in Q2 2021 (worse by $1.049M YoY); vs $(22.216)M in Q1 2022 (worse by $1.432M QoQ) .
  • Total Operating Expenses: +$4.002M YoY vs Q2 2021 ($22.572M), +$1.284M QoQ vs Q1 2022 ($25.290M) .

KPIs and Program Status

KPI / ProgramQ4 2021Q1 2022Q2 2022
MASTERS-2 Enrollment RateInitiatives to accelerate; 2022 completion target or shortly thereafter Continued enrollment; new sites initiated in EU/Asia Enrollment rate doubled vs prior years; Q2’22 highest quarterly enrollments
Active Trial Sites (MASTERS-2)NANA+10 new locations added (Germany, UK, Taiwan, Australia)
MACOVIA (ARDS)Ongoing; fast-track; bioreactor process transfer FDA approval to use bioreactor-manufactured product Suspended until financing/partnership; design informed by two dosing levels data
MATRICS-1 (Trauma)Program advancing OngoingFirst cohort enrollment completed; dosing initiated with bioreactor-derived product
TREASURE (Japan Stroke by Healios)Completion of enrollment; data expected Q2 2022 Last patient 365-day visit completed; topline data expected in May Missed primary 90-day endpoint; long-term functional outcomes improved; full results at World Stroke Congress (Oct)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Research & Development ExpenseFY 2022NAExpect R&D to decrease due to restructuring Lowered (qualitative)
General & Administrative ExpenseFY 2022NAExpect G&A to decrease due to restructuring Lowered (qualitative)
MACOVIA (ARDS) ProgramNext Phase TimingContinue pending designSuspended pending financing/partnership Lowered/Pushed Out
MASTERS-2 (Stroke) Focus2022 ExecutionOngoingPrioritized; enrollment rate doubled; expanded sites Raised Priority

No quantitative revenue/EPS/tax/OI&E guidance provided.

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2021)Previous Mentions (Q1 2022)Current Period (Q2 2022)Trend
Clinical Execution (Stroke)Aim to finish MASTERS-2 by end-2022 or soon after; address site/product supply constraints Continued enrollment; EU/Asia site initiation Reprioritized; doubled enrollment rate; +10 global sites Improving execution focus
Manufacturing StrategyTech transfer to CMO; bioreactor scale-up FDA approval to use bioreactor-manufactured product in MACOVIA/MATRICS Dosing in MATRICS-1 with large-scale bioreactor product; suspend costly manufacturing/process initiatives Shift to capital-light/partner-enabled
Financing / Cash RunwayCash $37.4M YE21; higher OpEx Cash down to $21.8M; OpEx elevated Cash $13.4M; exploring financing & strategic partners; restructuring to reduce OpEx Deteriorating liquidity; seeking solutions
Regulatory/Clinical Read-ThroughONE-BRIDGE ARDS positive topline (Japan) TREASURE 365-day complete; topline expected May TREASURE primary endpoint miss; longer-term functional outcomes supportive; plenary presentation Oct Mixed efficacy signals
Program PrioritizationBroad pipelineContinued multi-program progressMASTERS-2 prioritized; MACOVIA suspended; MATRICS-1 advancing Focused portfolio

Management Commentary

  • CEO perspective: “We also implemented a restructuring of our organization with the intention of significantly reducing expenses, conserving cash, improving focus of the Company’s activities and creating a positive impact on enrollment progress in our MASTERS-2 study. We are confident that the actions taken over the last two months will better position Athersys in bringing MultiStem to market and becoming a global leader in regenerative medicine.” — Dan Camardo .
  • Stroke program context: “While the topline data from the TREASURE study... did not reach statistical significance for its primary Endpoint... we are particularly pleased that the study demonstrated improvement in other pre-specified measures of functional outcomes over time, supporting the long-term impact of MultiStem in ischemic stroke patients.” — Dan Camardo .
  • Business development: Focused on securing regional/global MultiStem partners, non-dilutive funding, and complementary clinical/regulatory/commercial/manufacturing capabilities .

Q&A Highlights

  • Themes addressed included operational prioritization of MASTERS-2, implications of TREASURE results for trial design/read-through, manufacturing approach (bioreactor scale-up) and financing/partnership pathways; management hosted the call at 4:30 p.m. ET on Aug 11, 2022 .
  • Call logistics and replay links were provided in the press release; registration for Q&A participation described .

Estimates Context

  • Wall Street consensus (S&P Global) for ATHX was unavailable due to missing CIQ mapping at the time of this analysis. As a result, we cannot present vs-consensus comparisons for revenue or EPS for Q2 2022 (S&P Global estimates unavailable).
  • Actuals: Revenue $2.316M; EPS $(0.09) .
MetricPeriodWall Street Consensus (S&P Global)ActualBeat/Miss
Revenue ($M)Q2 2022Unavailable$2.316 N/A
EPS ($)Q2 2022Unavailable$(0.09) N/A

Key Takeaways for Investors

  • Execution pivot: The restructuring and reprioritization of MASTERS-2 is improving operational execution (higher enrollment velocity, expanded sites), sharpening near-term value creation around stroke .
  • Capital urgency: Cash declined to $13.4M; management is actively exploring financing and partnerships; watch for near-term capital actions and their terms .
  • Clinical risk/reward: TREASURE’s primary endpoint miss tempers near-term optimism, but longer-term functional improvements and KOL endorsements may still support the MultiStem thesis; plenary presentation in Oct as a potential narrative catalyst .
  • Portfolio focus: MACOVIA suspension concentrates resources; MATRICS-1 advances with scalable bioreactor product — a step toward manufacturability and potential cost-of-goods advantages .
  • Expense trajectory: R&D and G&A expected to decline post-restructuring, but Q2 included impairment/restructuring charges; monitor OpEx trend and how quickly savings materialize .
  • Strategic partnering: Management is pursuing regional/global partners and non-dilutive funding — deal optionality is a key medium-term driver of risk and dilution .
  • Near-term catalysts: Further MASTERS-2 enrollment updates, financing announcements, and detailed TREASURE data discussion at World Stroke Congress could move the stock narrative .

Additional Q2 2022 Press Releases and Materials

  • “Athersys Reports Second Quarter 2022 Financial Results and Provides Business Update” (Company press release) .
  • “Athersys to Host Second Quarter Financial Results Call” (July 26, 2022) .

Prior Two Quarters (for Trend Analysis)

  • Q1 2022: Revenue $2.912M; Net loss $(22.216)M; EPS $(0.09); total operating expenses $25.290M; cash $21.797M (period-end) .
  • Q4 2021: Revenue $0.722M; Net loss $(21.711)M; EPS $(0.09); total operating expenses $22.397M; cash $37.407M (year-end) .

Citations:

  • Q2 2022 8-K press release (Item 2.02 and Exhibit 99.1, including financial tables and management commentary) .
  • Q1 2022 8-K (financial results and program updates) .
  • Q4 2021 8-K (financial results and business highlights) .
  • Earnings call transcript (external sources) .