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Coya Therapeutics, Inc. (COYA)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 marked a pivotal operational quarter: collaboration revenue rose to $3.43M, driving a narrower net loss of $2.89M versus $3.10M YoY; cash increased to $36.6M, bolstered by partnership inflows .
  • FDA feedback requires additional non-clinical tox/pharm data before initiating the planned randomized, double-blind, placebo-controlled Phase 2 ALS trial for COYA 302; management aims to align the revised package in 4Q 2024 .
  • Strategic financing and BD tailwinds: $5.0M strategic investment from ADDF for COYA 302 in FTD and $3.85M received from Dr. Reddy’s First Amendment to fund the first U.S. Phase 2 ALS trial .
  • Near-term catalysts include CTAD24 AD data (Oct/Nov), Parkinson’s animal data by year-end, and FDA interactions in 4Q; management continues to explore partnering opportunities for COYA 302 beyond ALS .
  • Wall Street consensus estimates for Q2 2024 were unavailable via S&P Global during retrieval; beats/misses cannot be determined at this time (S&P Global data unavailable).

What Went Well and What Went Wrong

What Went Well

  • Collaboration revenue recognized at $3.43M (vs. $0 prior year), supported by Dr. Reddy’s collaboration; this helped shrink the quarterly net loss despite higher operating expenses .
  • Strengthened balance sheet and liquidity: cash and cash equivalents rose to $36.6M, supporting clinical plans and BD flexibility .
  • Expanded external validation and funding: $5.0M ADDF strategic investment for COYA 302 in FTD; CEO emphasized “Pipeline in a Drug” positioning and dual mechanism of LD IL-2 + CTLA4-Ig for multi-pathway neurodegenerative diseases .
    • Quote: “We bolstered our corporate and strategic efforts... COYA 302, our ‘Pipeline in a Drug.’... Together, we believe this novel combination approach could provide a new paradigm of treatment for neurodegenerative diseases.” — CEO Howard Berman .

What Went Wrong

  • Regulatory delay for ALS Phase 2: FDA requested additional non-clinical tox/pharm data prior to initiating the randomized Phase 2 ALS study; timeline pushed to post-4Q alignment .
  • Elevated R&D spend to advance COYA 302 in ALS (+$3.0M preclinical) pressured OpEx; R&D reached $4.57M vs. $1.07M prior year .
  • No formal quantitative financial guidance was provided; visibility into revenue cadence from collaborations remains limited near-term .

Financial Results

MetricQ2 2023Q1 2024Q2 2024
Collaboration Revenue ($USD)$0 $126,838 $3,425,271
Research & Development ($USD)$1,067,952 $3,138,159 $4,566,152
General & Administrative ($USD)$1,829,553 $2,439,841 $2,088,404
Total Operating Expenses ($USD)$3,254,345 $5,609,840 $6,661,396
Net Loss ($USD)$(3,095,375) $(5,051,913) $(2,891,680)
Net Loss per Share (Basic & Diluted) ($)$(0.31) $(0.35) $(0.19)
Weighted Avg. Shares (Basic & Diluted)9,947,915 14,457,839 14,915,217

Notes:

  • Margin metrics (gross/EBITDA) not applicable given collaboration-revenue model; company does not report segment margins .
  • The YoY reduction in net loss was primarily driven by collaboration revenue from Dr. Reddy’s and higher other income, partly offset by increased operating expenses .

KPIs and Balance Sheet Highlights

MetricDec 31, 2023Mar 31, 2024Jun 30, 2024
Cash & Cash Equivalents ($USD)$32,626,768 $35,989,406 $36,575,089
Collaboration Receivable ($USD)$7,500,000 $0 $0
Deferred Collaboration Revenue – Current ($USD)$923,109 $689,669 $939,035
Deferred Collaboration Revenue – Non-Current ($USD)$574,685 $681,287 $856,650
Total Current Liabilities ($USD)$5,051,980 $4,319,142 $3,825,365
Total Stockholders’ Equity ($USD)$35,635,609 $32,393,041 $35,256,600

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial guidance (Revenue, EPS, margins)FY/Q2 2024None providedNone providedMaintained (no formal guidance)
ALS Phase 2 (COYA 302) initiation2024IND planned in 2Q24 with initiation thereafter Additional non-clinical tox/pharm required before initiating; aiming to align with FDA in 4Q 2024 Deferred by regulatory feedback
AD LD IL-2 Ph 2 toplineSummer/CTAD 2024Summer 2024 topline expected Full dataset to be presented at CTAD24 (Oct 29–Nov 1, 2024) Timing reaffirmed/clarified

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript was available in our document catalog; themes reflect press-release narratives and prior quarter disclosures.

TopicPrevious Mentions (Q4 2023)Previous Mentions (Q1 2024)Current Period (Q2 2024)Trend
ALS program (COYA 302)IND filing anticipated in 2Q24; randomized Ph 2 planned Pre-IND/Type C completed; IND expected in 2Q24 FDA requested more non-clinical tox/pharm before Ph 2 initiation; plan to align in 4Q Regulatory timeline extended
Alzheimer’s (LD IL-2/COYA 302)Ph 2 LD IL-2 completed enrollment; topline Summer 2024 Summer 2024 readout guiding COYA 302 path Full dataset slated for CTAD24; attending ADDF Summit Data presentation window firmed
Biomarkers (4-HNE in ALS)Mechanism support; publications planned New data correlating 4-HNE with progression/survival; IP filed Updated biomarker data presented; predictive of survival; elevated in bulbar onset Expanding evidence base
Funding/PartnershipsIPO, 2023 private placement; Dr. Reddy’s deal terms Cash runway into 2026; exploring partnerships beyond ALS $5.0M ADDF investment; $3.85M received under Dr. Reddy’s amendment; partnership optionality highlighted Strengthened
Exosomes R&DCMU exosome engineering licensed Pipeline expansion; patent estate enlarged Expanded HMRI collaboration for exosomes Continuation/expansion

Management Commentary

  • “The dual mechanism of action of COYA 302, a combination of our proprietary LD IL-2 and CTLA4-Ig, could prove vital to addressing complex neurodegenerative diseases...” — CEO Howard Berman .
  • “FDA... feedback that additional non-clinical toxicology/pharmacology data must be submitted prior to initiating our planned randomized, double-blind, placebo-controlled Phase 2 study... Coya intends to discuss the recommendations with the FDA in 4Q 2024...” .
  • “$5 million strategic investment by the ADDF... help fund development of COYA 302 for FTD... evaluating plans for advancing COYA 302 in FTD into clinical trials.” .
  • “There are plenty of clinical, preclinical and regulatory milestones... cash balance of $36.6 million... provides us the flexibility to seek the best deal(s) possible for our shareholders.” .

Q&A Highlights

  • No Q2 2024 earnings call transcript was available; no Q&A themes or clarifications could be extracted from call materials (document catalog search returned none).

Estimates Context

  • Wall Street consensus estimates via S&P Global for Q2 2024 were unavailable at retrieval due to a data access limitation; therefore, we cannot quantify beats/misses for revenue or EPS (S&P Global data unavailable).
  • As a result, near-term estimate revisions may center on collaboration revenue cadence and ALS regulatory timing, but we cannot specify magnitude without consensus figures.

Key Takeaways for Investors

  • Collaboration revenue ramped ($3.43M) and net loss narrowed QoQ/YoY, aided by Dr. Reddy’s revenue recognition and other income; OpEx rose as R&D advanced COYA 302 in ALS .
  • Regulatory path in ALS shifted: additional tox/pharm data required pre-Phase 2; a 4Q FDA interaction is a key binary catalyst for timeline clarity .
  • Liquidity is strong ($36.6M cash); coupled with ADDF funding and Dr. Reddy’s proceeds, this underpins program execution and BD optionality .
  • Alzheimer’s readout visibility improved: full dataset presentation set for CTAD24; watch for signal that could inform COYA 302 trial design in AD .
  • Biomarker narrative strengthening (4-HNE in ALS); management is positioning the program with mechanistic validation across neurodegeneration .
  • With no formal quantitative guidance, monitor collaboration revenue timing, deferred revenue progression, and upcoming data/regulatory events as primary stock drivers .
  • Earnings estimate comparisons are unavailable; trading focus should be on catalysts and regulatory clarity rather than near-term EPS print (S&P Global data unavailable).