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Coya Therapeutics, Inc. (COYA)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 was a pre-revenue quarter with net loss of $4.02M and diluted EPS of -$0.26; operating expenses rose YoY as R&D and G&A scaled to support COYA‑302/301 programs .
  • Management highlighted strategic progress: FDA alignment on non‑clinical data for ALS Phase 2, CEO transition to Arun Swaminathan, new patents on COYA‑301/GLP‑1 combinations, and AD Phase 2 LD IL‑2 data presented at CTAD24 .
  • Cash and cash equivalents were $31.06M at quarter‑end, with an interim unaudited cash balance of $39.8M as of Oct 31, 2024 following capital raise, extending execution runway into 2025 catalysts .
  • Wall Street consensus from S&P Global was unavailable; third‑party trackers showed EPS beat versus external consensus proxies, framing a potential sentiment positive around cost discipline and pipeline clarity (see Estimates Context) .

What Went Well and What Went Wrong

What Went Well

  • FDA alignment: “We have clarity on the non‑clinical data needed to support the start of our Phase 2 study of COYA‑302 in patients with ALS and we are fully aligned with the FDA” — CMO Dr. Fred Grossman .
  • Strategic breadth: Positive AD Phase 2 LD IL‑2 data, new patents for COYA‑301/GLP‑1, and preclinical anti‑inflammatory brain effects in PD expand optionality; CEO transition positions execution focus for 2025 .
  • Liquidity: Cash of $31.06M at Sep 30, 2024 and unaudited $39.8M at Oct 31, 2024 post capital raise, supporting upcoming clinical/regulatory milestones .

What Went Wrong

  • No collaboration revenue in Q3 2024 (vs $3.43M in Q2), increasing reliance on financing and partnership receipts for near‑term cash inflows .
  • Operating expenses increased YoY: R&D $2.22M (+$0.63M YoY), G&A $2.22M (+$0.25M YoY), driving net loss of $4.02M versus $3.42M in Q3 2023 .
  • Prior FDA feedback in Q2 required additional non‑clinical tox/pharm data before initiating ALS Phase 2, modestly pushing timelines and adding non‑clinical workstreams .

Financial Results

Quarterly Comparison (Q1 → Q2 → Q3 2024)

MetricQ1 2024Q2 2024Q3 2024
Collaboration Revenue ($USD Millions)$0.13 $3.43 $0.00
Research & Development ($USD Millions)$3.14 $4.57 $2.22
General & Administrative ($USD Millions)$2.44 $2.09 $2.22
Other Income ($USD Millions)$0.43 $0.34 $0.43
Net Loss ($USD Millions)$5.05 $2.89 $4.02
Diluted EPS ($)-$0.35 -$0.19 -$0.26
Cash & Cash Equivalents ($USD Millions, period-end)$35.99 $36.58 $31.06

YoY Snapshot (Q3 2024 vs Q3 2023)

MetricQ3 2023Q3 2024YoY Change
Research & Development ($USD Millions)$1.59 $2.22 +$0.63
General & Administrative ($USD Millions)$1.96 $2.22 +$0.25
Other Income ($USD Millions)$0.14 $0.43 +$0.29
Net Loss ($USD Millions)$3.42 $4.02 +$0.60
Diluted EPS ($)-$0.34 -$0.26 +$0.08
Weighted Avg Shares (Millions)9.95 15.22 +5.27

KPIs/Operating details:

  • Deferred collaboration revenue (current + non‑current) at 9/30/24: $1.80M (current $0.57M, non‑current $1.22M), indicating future revenue recognition tied to progress/milestones .
  • Total operating expenses Q3 2024: $4.45M; loss from operations: -$4.45M .

Segment breakdown: Not applicable (clinical‑stage; no commercial segments) .

Guidance Changes

No formal quantitative financial guidance (revenue, margins, OpEx) was provided. Management outlined 2025 milestone/catalyst timelines and partnership economics.

Metric/ItemPeriodPrevious GuidanceCurrent GuidanceChange
ALS COYA‑302 Phase 2 start (after FDA alignment)2025 (data submission Q2 2025)FDA requested additional non‑clinical data (Aug 2024) Aligned on non‑clinical package; submit additional data to support Phase 2 start Clarified path
DRL Milestone Payments (ALS)Upon IND acceptance and first patient dosingNot previously quantifiedEligible to receive $8.4M upon IND acceptance and first patient dosing Newly specified
AD LD IL‑2 IIT additional data (blood immune panels/CSF biomarkers)Q1 2025Data presentation expected at CTAD24 (Oct/Nov 2024) Additional clinical/biomarker data release in Q1 2025 Timeline update
COYA‑301/GLP‑1 combo IP filingsQ1/Q2 2025Patents filed in 2024 Further data submission for publication and IP filings Extended
FTD IND for COYA‑3022H 2025IND planned for 2H24 IND expected likely in 2H 2025, post ALS IND acceptance Deferred
FTD IIT LD IL‑2 + CTLA‑4 Ig topline2H 2025IIT initiated Topline release 2H 2025 Firmed
PD preclinical data (COYA‑302)By end‑2024Anticipated release by YE 2024 Anti‑inflammatory brain effects announced Delivered

Earnings Call Themes & Trends

Earnings call transcript for Q3 2024 was not available in our document corpus; themes below reflect quarter‑over‑quarter press release narratives.

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q1 2024)Current Period (Q3 2024)Trend
FDA feedback & alignment (ALS Phase 2)FDA requested additional non‑clinical tox/pharm data (Aug 9 feedback) IND submission planned 2Q24 “Fully aligned with FDA” on required non‑clinical data for Phase 2 Improving regulatory clarity
AD LD IL‑2 clinical dataCTAD24 poster planned (Oct/Nov 2024) Phase 2 LD IL‑2 data expected Summer 2024 Positive AD LD IL‑2 data presented; more biomarker data in Q1 2025 Positive clinical signal
FTD programAD/PD conference biomarker/Treg data; FTD IND planned 2H24 Expanded pipeline to include FTD LD IL‑2+CTLA‑4 Ig IIT initiated; FTD IND likely 2H 2025 Progressing with adjusted timing
PD preclinicalAnticipated YE 2024 —Anti‑inflammatory effects of COYA‑302 in brain (mouse model) announced Delivered preclinical milestone
Partnerships & economics (DRL)$3.85M received from license amendment DRL exclusive ALS license (Dec 2023) $8.4M milestones eligible upon ALS IND acceptance and first dosing Enhanced partner milestones
Liquidity & runwayCash $36.58M; flexibility for partnerships Cash $35.99M; runway into 2026 Cash $31.06M at Q3; interim $39.8M at Oct 31 post raise Strengthened post‑raise

Management Commentary

  • CEO transition and focus: “As the new CEO of Coya, I am very encouraged by our progress in 2024… I will be keenly focused on delivering shareholder value over the next year.” — Arun Swaminathan, Ph.D. .
  • Mechanistic rationale: “We believe LD IL‑2 enhances and restores Treg function… while CTLA4‑Ig inhibits other inflammatory cell types… providing numerous advantages by targeting multiple immune pathways.” — CEO remarks on combination approach .
  • Regulatory pathway: “We have clarity on the non‑clinical data needed… and we are fully aligned with the FDA.” — CMO Dr. Fred Grossman on ALS Phase 2 path .
  • Liquidity: “Our recent capital raise provides additional flexibility and cushion… interim cash and cash equivalents (unaudited) was $39.8 million as of October 31, 2024.” — CEO .

Q&A Highlights

Earnings call transcript for Q3 2024 was not accessible; no Q&A content was available to extract from primary sources [earnings-call-transcript search returned no documents].

Estimates Context

  • S&P Global Wall Street consensus was unavailable due to access limitations; therefore, estimate comparisons cannot be anchored to SPGI in this report.
  • External proxies indicate EPS consensus of -$0.41 vs actual EPS of -$0.26, a beat; revenue expectation of ~$0.30M vs actual $0.00M (pre‑revenue quarter) .
  • Implications: Analysts may revisit quarterly collaboration revenue timing recognition and OpEx cadence assumptions given non‑clinical work and milestone‑driven receipts highlighted by management .

Q3 2024 vs External Consensus (Non‑SPGI proxies)

MetricExternal ConsensusActualResult
EPS ($)-$0.41 -$0.26 Beat
Revenue ($USD Millions)$0.30 $0.00 Miss/N/A (no revenue)

Key Takeaways for Investors

  • Regulatory path clarity in ALS reduces near‑term uncertainty; watch for submission of additional non‑clinical data and subsequent IND acceptance/process milestones (potential $8.4M from DRL upon IND acceptance and first dosing) .
  • Clinical optionality expanding: AD LD IL‑2 Phase 2 positive data and FTD IIT initiation strengthen the multi‑indication “pipeline‑in‑a‑product” thesis as COYA‑302 moves towards Phase 2 in ALS/FTD .
  • Liquidity improved post‑quarter; interim $39.8M cash (unaudited) at Oct 31, 2024 supports 2025 catalysts without immediate reliance on collaboration revenue .
  • Expect OpEx variability tied to non‑clinical and IND activities; Q3 showed lower R&D vs Q2 but higher YoY R&D/G&A as programs mature .
  • Near‑term trading catalysts: AD biomarker data in Q1 2025; ALS data submission Q2 2025; potential IND acceptance/milestone events; FTD IND in 2H 2025 .
  • Estimate models may need to recalibrate quarterly revenue recognition and OpEx phasing; if SPGI consensus becomes available, re‑benchmark EPS/FCF outlook accordingly .
  • Strategic focus under new CEO suggests partnership‑driven value creation across indications, with IP filings (COYA‑301/GLP‑1) potentially unlocking combo paths beyond neurodegeneration .