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ATHERSYS, INC / NEW (ATHX)·Q3 2022 Earnings Summary

Executive Summary

  • Restructuring largely completed with expense reductions underway; R&D fell to $12.4M in Q3 (from $20.8M in Q2), and net loss narrowed sequentially to $13.7M (from $23.6M in Q2) on lower OpEx and higher other income, despite minimal revenue recognized this quarter .
  • Liquidity actions: raised $12.0M via registered direct offering in Q3 and $5.5M post-quarter; executed a 1-for-25 reverse split to address Nasdaq bid price compliance .
  • Clinical execution: MASTERS-2 enrollment accelerated (average monthly rate doubled vs prior years), new sites added in Germany, UK, Taiwan, Australia; MATRICS-1 advanced dosing with large-scale bioreactor product .
  • Revenue dropped to $0.065M as Healios service deliverables wound down, materially below prior-year $4.792M; no formal guidance or Street consensus was available to judge beats/misses (S&P Global consensus unavailable) .

What Went Well and What Went Wrong

What Went Well

  • “Our restructuring initiative is now largely complete and has yielded significant expense savings and a streamlined organization,” enabling lower R&D and expected lower G&A going forward (CEO Dan Camardo) .
  • MASTERS-2 enrollment momentum: “Doubled the average number of patients enrolled per month in 2022 from prior years” and expanded the network with additional international key stroke centers .
  • Operational execution: MATRICS-1 initiated dosing with product from large-scale bioreactors (improves scalability/cost); transfer of certain MultiStem manufacturing rights to Healios supports partner’s clinical work .

What Went Wrong

  • Revenue collapsed to $0.065M as Healios services were “largely complete,” versus $4.792M in Q3 2021, removing a prior contribution and magnifying GAAP loss margins .
  • Cash burn remains heavy: net cash used in operating activities reached $47.0M for the first nine months; quarter-end cash was $13.8M, underscoring financing dependency .
  • Continued risk disclosures: ability to raise capital and resolve “payment issues with our primary contract manufacturer” to access clinical product; Nasdaq minimum market value compliance risk noted .

Financial Results

Metric (USD)Q3 2021Q1 2022Q2 2022Q3 2022
Revenue ($MM)$4.792 $2.912 $2.316 $0.065
R&D Expense ($MM)$17.162 $20.944 $20.794 $12.424
G&A Expense ($MM)$3.632 $4.099 $5.162 $3.737
Depreciation ($MM)$0.220 $0.247 $0.618 $0.617
Total Costs & Expenses ($MM)$21.014 $25.290 $26.574 $16.778
Loss from Operations ($MM)$(16.222) $(22.378) $(24.258) $(16.713)
Other Income ($MM)$0.045 $0.162 $0.610 $3.044
Net Loss ($MM)$(16.177) $(22.216) $(23.648) $(13.669)
Diluted EPS$(1.76) $(0.09) $(0.09) $(1.15)
Weighted Avg Shares (MM)9.169 244.197 259.570 11.855

Notes: EPS/share counts are not comparable across periods due to the 1-for-25 reverse stock split executed in 2022 and subsequent financing; Q3 2022 reflects the post-split share base while earlier quarters reflect pre-split shares .
Estimates: S&P Global consensus for Q3 2022 revenue and EPS was unavailable for ATHX; therefore, no vs-consensus comparison is provided (S&P Global consensus unavailable).

Balance sheet and liquidity

Metric (USD)Q1 2022Q2 2022Q3 2022
Cash & Cash Equivalents ($MM)$21.797 $13.378 $13.782
Total Assets ($MM)$44.959 $35.204 $35.543
Total Stockholders’ Equity ($MM)$0.307 $(11.738) $(16.613)
Advance from Healios ($MM)$5.199 $5.199 $5.199
Deferred Revenue – Healios ($MM)$2.202 $0.000 $0.000
Net Cash Used in Operating Activities (YTD) ($MM)$20.2 (Q1) $36.6 (H1) $47.0 (9M)

KPIs and operating updates

KPIQ1 2022Q2 2022Q3 2022
MASTERS-2 enrollment paceContinued enrollment; new sites in EU/Asia “Doubled” avg monthly enrollments in 2022; +10 new sites Enrollment “stepped up considerably”; new sites in DE/UK/TW/AU
MACOVIA (ARDS)Ongoing; bioreactor product approved Suspended pending financing/partner No change (focus on stroke)
MATRICS-1 (Trauma)Progressing First cohort enrolled; dosing with bioreactor product Continued dosing; streamline enrollment process
ManufacturingFDA approvals for bioreactor process Restructuring; paused costly mfg/process dev Transferred certain mfg rights to Healios; suspended high-cost initiatives
Capital structureRestructuring announced $12.0M raised; additional $5.5M post-Q3; 1-for-25 reverse split

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
R&D ExpenseForward periodsNone provided“Expect…to decrease in connection with restructuring plan” Lowered (directional)
G&A ExpenseForward periodsNone provided“Expect…to decrease in connection with restructuring plan” Lowered (directional)
MACOVIA trial status2022 onwardAdvancing in Q1 Suspended pending financing/partner Lowered/Pause
Revenue/EPS/Tax/SegmentsNoneNone providedN/A

Earnings Call Themes & Trends

Note: Q3 2022 earnings call transcript could not be retrieved due to a source database issue; themes below reflect company disclosures across Q1–Q3 press materials.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2022)Trend
Stroke (MASTERS-2) executionQ1: enrollment continued; new EU/Asia sites . Q2: average monthly enrollment doubled; +10 sites; TREASURE readthrough .Enrollment “stepped up considerably”; additional international key centers added .Improving
ARDS (MACOVIA)Q1: progressing; bioreactor product cleared .Suspended pending financing/partner .Deprioritized
Trauma (MATRICS-1)Q1: progressing . Q2: first cohort enrolled; dosing with bioreactor product .Continued dosing; enabling enrollment without prior consent .Advancing
Manufacturing strategyQ1: FDA approvals for bioreactor process . Q2: suspended expensive mfg/process development .Transferred certain mfg rights to Healios; sublet Stow facility .Streamlining/Partnering
Financing & listingQ2: restructuring underway .$12.0M raise + $5.5M post-Q3; 1-for-25 reverse split; risk on Nasdaq market value compliance .Bolstering liquidity; listing risk remains

Management Commentary

  • “Our restructuring initiative is now largely complete and has yielded significant expense savings and a streamlined organization… Enrollment in our MASTERS-2 clinical trial has stepped up considerably and we continue to seek strategic partnership opportunities to advance our MultiStem platform and provide non-dilutive funding.” — CEO Dan Camardo .
  • Q2 context: “We implemented a restructuring… significantly reducing expenses, conserving cash, improving focus… We are confident that the actions taken… will better position Athersys in bringing MultiStem to market…” — CEO Dan Camardo .

Q&A Highlights

  • Q3 2022 earnings call transcript was unavailable due to a source database inconsistency; as a result, Q&A themes and any guidance clarifications could not be reviewed.

Estimates Context

  • S&P Global consensus for ATHX Q3 2022 revenue and EPS was unavailable in our data access at the time of analysis; therefore, we cannot assess beats/misses versus Street for the quarter (S&P Global consensus unavailable).
  • Given the minimal recognized revenue and the company’s development stage, near-term estimate revisions (where they exist) would likely focus on OpEx runway and clinical timelines rather than top-line/EPS, especially as management indicated R&D and G&A should trend lower post-restructuring .

Key Takeaways for Investors

  • Cost inflection achieved: R&D down ~40% QoQ ($20.8M → $12.4M) with G&A also set to trend lower, materially narrowing sequential net loss ($23.6M → $13.7M) and extending runway post capital raises .
  • Revenue near zero as Healios service revenue winds down; model should emphasize cash, OpEx trajectory, and partnership timing rather than GAAP margins near-term .
  • Clinical momentum in stroke (MASTERS-2) is the central value driver; continued enrollment acceleration and site additions are key catalysts to monitor .
  • Financing/listing risks persist despite $17.5M gross proceeds around the quarter and the reverse split; management explicitly flags market value compliance risk and the need to secure additional capital/partners .
  • Manufacturing strategy is shifting to partner-enabled approaches (e.g., Healios rights transfer), aligning cost structure with focus on pivotal stroke execution .
  • For trading: watch for enrollment milestones, partnership announcements, and any updates on Nasdaq compliance or additional financing as near-term stock catalysts .

Supporting details and why:

  • The sequential loss improvement was driven by restructuring-driven OpEx cuts and higher other income ($3.0M), while revenue recognition receded as Healios services completed .
  • Liquidity remains the critical constraint given $13.8M cash at Q3-end and $47.0M YTD operating cash outflow; the quarter’s financing and post-quarter raise help but do not eliminate ongoing funding needs .
  • Strategy pivots (suspending MACOVIA, transferring certain manufacturing rights, subletting facilities) reduce burn and concentrate resources on MASTERS-2, aligning with value-creation path .

References: All figures, quotes, and disclosures cited from Athersys’ Q3 2022 8-K press release and financial statements , Q2 2022 8-K press release and financials , and Q1 2022 8-K press release and financials .