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Coya Therapeutics, Inc. (COYA)·Q4 2024 Earnings Summary

Executive Summary

  • FY 2024 audited results showed cash and equivalents of $38.34M, collaboration revenue of $3.55M, and net loss of $14.88M as COYA accelerated pipeline investments; Q4 collaboration revenue was minimal and loss narrowed vs Q3 .
  • The company reiterated 2025 operational milestones: ALS Phase 2b nonclinical data submission in Q2, FTD IND in 2H 2025, and multiple data publications, sustaining the narrative of near-term clinical catalysts .
  • No formal financial guidance was provided; management emphasized strong cash runway, external funding support (ADDF $5.0M) and DRL potential milestones ($8.4M upon ALS IND acceptance and first dosing) as execution and funding pillars .
  • Street consensus via S&P Global was unavailable at time of retrieval; third-party data indicated a Q4 EPS beat and revenue beat vs non-S&P estimates, which may influence near-term sentiment pending validation by institutional sources .

What Went Well and What Went Wrong

What Went Well

  • Cash position strengthened to $38.34M at year-end, aided by capital raises and warrant exercises, supporting 2025 clinical milestones and business development optionality .
  • Regulatory and clinical progress: alignment with FDA on nonclinical data requirements for ALS Phase 2b; expanded pipeline (COYA-303; COYA-301 + GLP-1 RA) and positive AD biomarker study updates, bolstering the multi-pathway thesis .
  • Management tone constructive: “We remain encouraged by the progress we made in 2024… on track to initiate the randomized, double-blind controlled Phase 2b trial in patients with ALS upon IND acceptance,” CEO Arun Swaminathan said .

What Went Wrong

  • Elevated operating spend: R&D rose to $11.87M (from $5.50M) and G&A to $8.89M (from $7.83M) in FY 2024, widening net loss to $14.88M (from $7.99M); spend was driven by preclinical advancement and internal R&D .
  • Q4 revenue recognition was minimal (collaboration revenue effectively flat vs nine months), highlighting limited near-term topline while the model remains pipeline-dependent .
  • Earlier in 2024, FDA requested additional nonclinical tox/pharm data prior to initiating ALS Phase 2; though later aligned, this extended timelines and increased preclinical costs .

Financial Results

Income Statement and Cash Metrics (Quarterly)

MetricQ2 2024Q3 2024Q4 2024
Collaboration Revenue ($USD Millions)$3.425 $0.000 $0.002 (FY $3.554 − 9M $3.552)
Total Operating Expenses ($USD Millions)$6.661 $4.450 $4.083 (FY $20.804 − 9M $16.722)
Net Loss ($USD Millions)$2.892 $4.021 $2.916 (FY $14.881 − 9M $11.965)
Diluted EPS ($USD)-$0.19 -$0.26 -$0.18
Cash and Equivalents ($USD Millions)$36.575 $31.057 $38.340

Notes: S&P Global consensus data unavailable; Q4 EPS sourced from third-party (MarketBeat). Nine-month totals from Q3 press release used to derive Q4 figures where quarter detail was not explicitly provided .

Operating Expense Mix (Quarterly)

MetricQ2 2024Q3 2024Q4 2024
R&D Expense ($USD Millions)$4.566 $2.224 $1.938 (FY $11.866 − 9M $9.928)
G&A Expense ($USD Millions)$2.088 $2.220 $2.138 (FY $8.886 − 9M $6.748)

Margins: Net income margin not meaningful for Q3 and Q4 given negligible collaboration revenue; Q2 margin reflects negative profitability due to R&D/G&A investment against one-time collaboration revenue recognition .

Estimates vs Actual (Q4 2024)

MetricConsensusActualBeat/Miss
EPS ($USD)-$0.32 -$0.18 Beat (+$0.14)
Revenue ($USD Millions)$0.10 $0.002 (derived) Miss vs third-party; primary docs indicate negligible Q4 revenue

Important: S&P Global consensus was unavailable at time of retrieval; above consensus figures are from MarketBeat for context. Primary documents indicate FY 2024 collaboration revenue of $3.554M and nine months revenue of $3.552M, implying minimal Q4 recognition .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ALS COYA-302 Phase 2b start (nonclinical package)2025Aligned with FDA; submit additional data; targeting start post-IND acceptance Q2 2025 submission of additional nonclinical data; initiate upon IND acceptance Maintained timing/steps
FTD COYA-302 IND2H 2025IND submission expected in 2H 2025 2H 2025: IND filing for Phase 2 trial Maintained
COYA-303 combo mechanistic dataQ2 2025Not previously datedQ2 2025 publication New datapoint
ALS biomarker publications (NfL, oxidative stress)Q2 2025ALS biomarker dataset planned Q2 2025 publication Maintained
AD LD IL-2 single-cell proteomics2H 2025Expect comprehensive AD data post-CTAD24 2H 2025 additional single cell proteomics data Maintained
FTD IIT top-line (LD IL-2 + CTLA4-Ig)2H 2025IIT initiated 2H 2025 top-line clinical data Progressed to data timing
DRL milestones (ALS)Upon IND acceptance & first dosingEligible for $8.4M upon IND acceptance and first patient dosing Same eligibility reiterated Maintained

No financial guidance (revenue, margins, OpEx ranges, tax rate, dividends) was issued .

Earnings Call Themes & Trends

Note: No Q4 earnings call transcript found in document catalog; themes below synthesize press releases across quarters.

TopicQ2 2024 (Prev Q-2)Q3 2024 (Prev Q-1)Q4 2024 (Current Period)Trend
ALS program (COYA-302)IND submitted; FDA requested more nonclinical tox/pharm data prior to Phase 2 start Aligned with FDA on nonclinical package for Phase 2b On track: submit nonclinical data in Q2 2025; initiate upon IND acceptance Progression towards initiation
FTD programPipeline expansion; planning IND in 2H 2024 IIT combining LD IL-2 + CTLA4-Ig began IND planned for 2H 2025; top-line IIT data expected in 2H 2025 Advancing IIT, IND timing clarified
AD programExpect Ph2 LD IL-2 data in summer; informs COYA-302 strategy in AD Positive LD IL-2 data at CTAD24; additional blood/CSF biomarkers planned Q1 2025 2H 2025 single-cell proteomics data planned Continued data generation
PD preclinicalAnimal model data anticipated by year-end Anti-inflammatory effects in brain in PD model announced Publication on inflammation in PD planned Q2 2025 Ongoing preclinical outputs
Funding/BDCash $36.6M; ADDF $5.0M, DRL $3.85M; private placement context Promoted new CEO; interim cash $39.8M; exploring partnerships Cash $38.34M YE; reiterates potential BD and DRL milestones Stable funding, BD optionality

Management Commentary

  • CEO Arun Swaminathan: “We remain encouraged by the progress we made in 2024… we are on track to initiate the randomized, double-blind controlled Phase 2b trial in patients with ALS upon IND acceptance” .
  • CEO (Q3) Swaminathan: “I am very encouraged by our progress in 2024… keenly focused on delivering shareholder value over the next year” .
  • CMO Dr. Fred Grossman (Q3): “We have clarity on the non-clinical data needed… fully aligned with the FDA… confident in the path forward towards the completion of this important potential pivotal trial” .
  • CMO Grossman (Q4): “We expect 2025 to hold important milestones… initiate the phase 2b trial of COYA 302 in ALS… submitting an IND for a phase 2b study of COYA 302 in FTD” .

Q&A Highlights

  • No Q4 earnings call transcript or Q&A was available in the document catalog; third-party sites listed a conference call on March 18, 2025 but a transcript was not accessible via primary sources .
  • Guidance clarifications noted in press releases: timeline and regulatory alignment for ALS Phase 2b and FTD IND .

Estimates Context

  • S&P Global consensus estimates were unavailable at time of retrieval; as such, estimates comparisons anchored to SPGI are not provided.
  • For context only, third-party data suggested Q4 EPS consensus of -$0.32 vs actual -$0.18 (beat by $0.14) and revenue consensus of $0.10M vs actual minimal revenue per primary filings; traders may treat this as provisional pending S&P validation .

Key Takeaways for Investors

  • Cash runway and external funding (ADDF $5.0M; YE cash $38.34M) underwrite 2025 clinical milestones, reducing near-term financing risk vs typical micro-cap biotech peers .
  • Regulatory path for ALS Phase 2b appears clarified and time-bound (Q2 2025 nonclinical submission, initiation post-IND acceptance), supporting a catalyst-driven setup through 2H 2025 .
  • FTD program advances with IIT combo data expected in 2H 2025 and IND in 2H 2025, diversifying optionality beyond ALS .
  • Minimal Q4 collaboration revenue and rising R&D/G&A reflect an R&D-stage profile; near-term stock drivers are clinical/regulatory events rather than financials .
  • Multi-pathway approach (LD IL-2 + CTLA4-Ig) and mechanistic readouts (AD, PD) continue to build the scientific narrative; additional single-cell proteomics and biomarker publications are near-term visibility events .
  • Potential DRL milestones ($8.4M) on ALS IND acceptance/first dosing provide non-dilutive funding triggers tied directly to execution .
  • Trading setup: attention on Q2 2025 nonclinical submission for ALS and subsequent IND acceptance; stock likely sensitive to regulatory updates and IIT readouts for FTD in 2H 2025 .

S&P Global disclaimer: Consensus estimates from S&P Global were unavailable at time of retrieval. Where third-party estimates are shown, they are for context only and should be validated against SPGI.