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Clearside Biomedical, Inc. (CLSD)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 delivered positive clinical and operational updates while remaining a development-stage P&L: license and other revenue was $1.038M, net loss was $7.688M (EPS -$0.10), and cash, cash equivalents and short-term investments were $23.6M with runway into Q3 2025 .
  • ODYSSEY Phase 2b in wet AMD achieved primary and secondary outcomes; CLS-AX showed extended durability, flexible redosing between 12–36 weeks, and a well‑tolerated safety profile, positioning the asset for Phase 3 with a targeted flexible 3–6 month maintenance dosing label .
  • Strategic validation strengthened via Arctic Vision’s collaboration with Santen for China and multiple partner programs advancing suprachoroidal delivery with Clearside’s SCS Microinjector .
  • Near-term catalysts: End‑of‑Phase 2 FDA meeting in early 2025 and Phase 3 start targeted for 2H 2025; AAO reception was favorable, reinforcing flexible dosing differentiation versus competitors .
  • Street consensus estimates were not available through S&P Global at the time of analysis; no company-provided guidance on revenue/EPS was issued .

What Went Well and What Went Wrong

What Went Well

  • ODYSSEY met all primary and secondary outcomes with extended durability: 90% needed no additional treatment up to 4 months, 81% up to 5 months, and 67% up to 6 months; injection frequency reduced ~84% versus baseline, supporting flexible redosing and reduced treatment burden .
  • Management emphasized platform leadership and clinical safety; CEO: “We continue to make outstanding progress advancing our differentiated suprachoroidal delivery pipeline” .
  • AAO feedback underscored differentiation of flexibility and redosing; CMO: “We are the only one who are offering a variability… physicians are really very keen on [it]” .
  • Strategic validation: Arctic Vision–Santen collaboration for China commercial rights to ARVN001/ARCATUS, plus partner updates at REGENXBIO/AbbVie, Aura Biosciences, BioCryst .

What Went Wrong

  • Continuing operating losses and limited top-line: Q3 license and other revenue $1.038M; net loss $7.688M; loss from operations $(5.934)M; underscores dependence on milestones/services rather than product revenues .
  • Balance sheet shows high liabilities tied to royalty funding and warrant liabilities; royalty liability net $49.188M and warrant liabilities $8.757M; stockholders’ deficit $(34.789)M .
  • No quantitative guidance (revenue/margins) and Phase 3 cost estimates remain unprovided; management noted cost detail is premature until Phase 3 design finalization .

Financial Results

Income Statement and EPS

MetricQ3 2023Q1 2024Q2 2024Q3 2024
License and other revenue ($USD Thousands)$859 $230 $90 $1,038
Total operating expenses ($USD Thousands)$7,913 $8,439 $7,680 $6,972
Loss from operations ($USD Thousands)$(7,054) $(8,209) $(7,590) $(5,934)
Interest income ($USD Thousands)$409 $348 $419 $338
Other income (expense), net ($USD Thousands)— $(1,499) $1,917 $365
Non-cash interest expense on royalty liability ($USD Thousands)$(2,622) $(2,403) $(2,340) $(2,457)
Net loss ($USD Thousands)$(9,267) $(11,763) $(7,594) $(7,688)
Net loss per share ($USD)$(0.15) $(0.17) $(0.10) $(0.10)
Weighted avg. shares outstanding (basic/diluted)61,983,987 69,853,227 74,731,139 74,745,415

Narrative highlights:

  • YoY: G&A +$0.2M; R&D −$1.0M; net loss improved by $1.6M; reflects lower CLS‑AX program costs .
  • QoQ: license revenue increased materially from $90k to $1.038M; operating expenses declined, improving loss from operations .

Balance Sheet

MetricDec 31, 2023Jun 30, 2024Sep 30, 2024
Cash and cash equivalents ($USD Thousands)$28,920 $18,238 $13,888
Short‑term investments ($USD Thousands)— $11,122 $9,703
Total assets ($USD Thousands)$34,018 $33,934 $29,161
Liabilities related to sales of future royalties, net ($USD Thousands)$41,988 $46,731 $49,188
Warrant liabilities ($USD Thousands)— $9,121 $8,757
Total liabilities ($USD Thousands)$49,930 $62,219 $63,950
Total stockholders’ deficit ($USD Thousands)$(15,912) $(28,285) $(34,789)

KPIs (ODYSSEY Phase 2b – Wet AMD)

KPIValue
Participants not needing additional treatment up to 12 weeks100% (n=40/40)
Up to 16 weeks90% (n=35/39)
Up to 20 weeks81% (n=30/37)
Up to 24 weeks (before mandatory Week 24 redose)67% (n=26/39)
Injection frequency reduction vs 24 weeks pre‑screening~84%
Safety to Week 36No ocular SAEs; no endophthalmitis; no retinal vasculitis

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough Q3 2025“Into the third quarter of 2025” (Q2 disclosure) “Into the third quarter of 2025” (Q3 disclosure) Maintained
ODYSSEY toplineLate Q3 2024“Topline data expected in late Q3 2024” Reported as positive (Oct 9 and AAO sessions) Achieved
End‑of‑Phase 2 FDA meetingEarly 2025Not previously specified“Expect to conduct EoP2 meeting early 2025” New/Specified
Phase 3 start timing2025Not previously specified“Target to start Phase 3 in 2H 2025” New/Specified
Phase 3 designWet AMD, comparatorInternal planning; flexible dosing concept discussed Non‑inferiority vs aflibercept 2 mg with flexible 3–6 month dosing; human‑naïve patients likely Clarified
Non‑inferiority margin (expectation)Phase 3Not specifiedDraft guidance suggests 4.5 letters (to be finalized with FDA) Informational

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 and Q2)Current Period (Q3 2024)Trend
CLS‑AX durability and flexible dosingEmphasized goal to maintain VA without retreatment up to 6 months; ODYSSEY design includes redosing at 6 months if needed Achieved primary/secondary outcomes; strong intervention‑free rates; flexible redosing 12–36 weeks; aiming for label enabling 3–6 months dosing Strengthening; de‑risked by Phase 2b data
Safety profileNo SAEs noted by Safety Review Committee in masked data; protocol continuation No ocular/treatment‑related SAEs; no endophthalmitis/retinal vasculitis through Week 36 Consistent, positive
Regulatory pathPlanning Phase 3 pending ODYSSEY; internal design discussion EoP2 meeting early 2025; Phase 3 start targeted for 2H 2025; likely NI vs aflibercept 2 mg; draft NI margin ~4.5 letters Clearer milestones
Platform/partnersREGENXBIO/AbbVie progressing; real‑world XIPERE durability; CPT code adoption Arctic Vision–Santen collaboration; REGENXBIO accelerated EoP2 in DR; Aura Phase 2 positive; BioCryst DME trial plans Broadening validation
Geographic atrophy pipelineKOL webinar highlighted GA opportunity; platform applicability Two approaches (choroidal perfusion, inflammatory cell moderation); advancing candidate toward IND Emerging focus

Management Commentary

  • CEO: “We continue to make outstanding progress advancing our differentiated suprachoroidal delivery pipeline… CLS‑AX is now positioned for real‑world success… with extended duration maintenance therapy combined with the option for flexible redosing” .
  • CMO: “We are focused on designing a Phase III program… supportive of label with flexible dosing between 3 to 6 months… likely… human naïve patients… comparator aflibercept 2‑mg” .
  • CFO: “As of September 30, 2024, our cash and cash equivalents totaled approximately $23.6 million… sufficient resources to fund planned operations into the third quarter of 2025” .
  • AAO feedback: “We are the only one who are offering a variability… that variability is what physicians are really very keen on” .

Q&A Highlights

  • AAO reception and design: Analysts probed retreatment vs rescue; management clarified Phase IIb enabled redosing and that no interventions were needed up to week 12 in CLS‑AX arm .
  • Phase 3 specification: Team indicated non‑inferiority with flexible dosing vs aflibercept 2 mg, human‑naïve patients likely; NI margin expectation from draft guidance ~4.5 letters (final specs post FDA meeting) .
  • Timing and costs: Phase 3 targeted to start in 2H 2025; costs not yet disclosed pending design finalization .
  • GA program: Mechanistic emphasis on choroid involvement; two candidate approaches under in vivo evaluation; IND timing not yet specified .

Estimates Context

  • Street consensus via S&P Global was not available at the time of analysis; the company did not provide revenue/EPS guidance in Q3 materials, so beat/miss vs estimates cannot be assessed .
  • Given development-stage revenue mix, near-term estimate revisions (if/when available) will likely focus on Phase 3 timelines for CLS‑AX and cash runway rather than top-line growth .

Key Takeaways for Investors

  • CLS‑AX de‑risked on durability and safety; flexible redosing between 12–36 weeks and targeted 3–6 month label could be commercially differentiated versus competitors pursuing fixed longer intervals .
  • Regulatory visibility improved: EoP2 in early 2025; Phase 3 start targeted for 2H 2025; draft NI margin context (~4.5 letters) informs design and feasibility .
  • Platform validation is strengthening via Arctic Vision–Santen and partner programs (REGENXBIO/AbbVie, Aura, BioCryst), supporting optionality beyond CLS‑AX .
  • Financial posture: runway into Q3 2025, but royalty/warrant liabilities drive stockholders’ deficit; monitor financing plans tied to Phase 3 initiation .
  • Near-term trading implications: incremental ODYSSEY data presentations (APVRS, Floretina, angiogenesis meetings) and FDA EoP2 scheduling updates could catalyze sentiment; watch for Phase 3 design clarity and funding path .
  • Medium-term thesis: If Phase 3 confirms flexible 3–6 month maintenance efficacy with safety, CLS‑AX could ease treatment burden and fit existing practice patterns, potentially expanding share in wet AMD maintenance treatment .

Appendix: Other Relevant Q3 Press Releases

  • “Clearside Biomedical Announces Third Quarter 2024 Financial Results and Provides Corporate Update”: financials and corporate highlights; cash + ST investments $23.6M; net loss $7.7M; validation via Arctic Vision–Santen .
  • AAO/ODYSSEY press releases: detailed intervention‑free rates, safety profile, and flexible dosing narrative supportive of Phase 3 .
Note: No non‑GAAP adjustments were disclosed; all metrics above reflect GAAP reporting from company materials.