Executive Summary

Reported Q1 2024 collaboration revenue of $0.127M and net loss of $5.05M; diluted EPS was $(0.35), widening from $(0.28) in Q1 2023; cash and cash equivalents were $36.0M, with management stating runway into 2026 .
Strategic momentum: IND for COYA 302 in ALS expected in 2Q24, with subsequent Phase 2 initiation; FTD IND targeted for 2H24; AD Phase 2 LD IL-2 topline data expected summer 2024; PD animal data expected 2H24 .
Business development: Dr. Reddy’s exclusive license for COYA 302 in ALS across U.S./Canada/EU/UK (potential $733M in upfront and milestones plus low-to-mid-teens royalties) and additional partnership discussions ongoing .
Estimates context: Unable to retrieve S&P Global consensus at this time due to request limit, so estimate comparisons are not available; focus remains on upcoming clinical catalysts as primary near-term stock drivers [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

Expanded pipeline beyond ALS into FTD, Parkinson’s, and Alzheimer’s, reinforcing “pipeline in a product” strategy for COYA 302. “We expanded our clinical pipeline… into FTD, Parkinson’s, and Alzheimer’s diseases” .
Biomarker progress: presented novel ALS biomarker (4-HNE) correlating with progression and survival; updated data show 4-HNE predictive of survival and elevated at diagnosis in bulbar vs. limb-onset ALS; IP filings submitted on multiple uses .
Funding visibility and discipline: cash of $36.0M with runway into 2026; management is patient on future commercial negotiations to maximize shareholder value .

What Went Wrong

Operating expense pressure: R&D rose to $3.14M from $1.23M (+$1.91M), and G&A increased to $2.44M from $1.66M (+$0.78M) year over year, reflecting increased preclinical and personnel/consulting spend .
Loss widened: net loss was $5.05M vs. $2.74M in Q1 2023, and diluted EPS declined to $(0.35) from $(0.28) .
Limited revenue base: collaboration revenue only ($0.127M), no product sales reported; operating loss driven by R&D and G&A investment .

Financial Results

Income Statement (YoY comparison)

Metric	Q1 2023	Q1 2024
Collaboration Revenue ($USD)	$0	$126,838
Net Loss ($USD)	$(2,736,462)	$(5,051,913)
Diluted EPS ($USD)	$(0.28)	$(0.35)

Operating Expenses (YoY)

Metric	Q1 2023	Q1 2024
Research and Development ($USD)	$1,231,712	$3,138,159
In-Process R&D ($USD)	$0	$25,000
General and Administrative ($USD)	$1,661,544	$2,439,841
Total Operating Expenses ($USD)	$2,900,096	$5,609,840

Trend KPIs (cash and shares)

Metric	Q3 2023	Q4 2023	Q1 2024
Cash and Cash Equivalents ($USD)	$10,886,282	$32,626,768	$35,989,406
Weighted Avg Shares (Basic & Diluted)	9,947,915	N/A	14,457,839

Notes:

No quarterly Q4 2023 income statement detail was disclosed in the FY 2023 8‑K; Q4 2023 presented on an annual basis .

Margins

Metric	Q1 2023	Q1 2024
Gross Margin %	N/A	N/A
Net Income Margin %	N/A	N/A
Notes: Collaboration revenue only and no product COGS disclosed; margin metrics not applicable from provided data .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
ALS (COYA 302) IND filing	2Q24	IND expected 1H24 (ALS)	IND expected to be filed in 2Q24; Ph. 2 to initiate thereafter	Maintained/timed
ALS Ph. 2 topline	2025	Topline data expected in 2025	Reiterated via IND/Ph. 2 plan	Maintained
FTD (COYA 302) IND filing	2H24	IND planned in 2H24	IND expected to be filed in 2H24	Maintained
Parkinson’s (COYA 302) preclinical	2H24	Animal data to be released in 2H24	Animal data to be released in 2H24	Maintained
AD (COYA 301/302) clinical	Summer 2024	AD Phase 2 LD IL‑2 topline Summer 2024	AD Phase 2 LD IL‑2 data expected Summer 2024; informs COYA 302 design	Maintained/clarified
ALS biomarker (4‑HNE) in Ph. 2	2024 planning	Biomarker work ongoing	In discussions with FDA on inclusion of 4‑HNE in expected Ph. 2	New detail
Cash runway	Through 2026	“Meaningful cash runway into 2026” aided by financing and Dr. Reddy’s	“Cash and cash equivalents… $36.0 million provides us a runway into 2026”	Maintained

Earnings Call Themes & Trends

No Q1 2024 earnings call transcript was found in our document set; themes are derived from Q3 2023 and FY2023 press releases and the Q1 2024 8‑K press release [ListDocuments results; 0 transcripts].

Topic	Previous Mentions (Q3 2023, Nov-8)	Previous Mentions (FY2023, Mar-19)	Current Period (Q1 2024, May-9)	Trend
ALS – COYA 302 IND & Ph. 2	IND in 1H24; planning Ph. 2 efficacy/safety	IND 2Q24; Ph. 2 initiation; topline 2025	IND 2Q24; Ph. 2 initiation; 4‑HNE biomarker FDA discussions	Steady execution with added biomarker clarity
AD – LD IL‑2 Phase 2 data	Topline Summer 2024 expected	Phase 2 completed Oct 2023; data guide 302 design	Phase 2 LD IL‑2 data Summer 2024; informs COYA 302 AD strategy	Consistent timing; reinforces 302 strategy
FTD – COYA 302 IND	—	IND 2H24 planned	IND 2H24 expected; presented Treg dysfunction/inflammation data	Advancing; added mechanistic data
PD – COYA 302	—	Animal data 2H24	Animal data 2H24	Maintained
Biomarkers – 4‑HNE in ALS	Mechanism/supporting data presented (NEALS)	Novel biomarker data correlating with progression/survival; IP filed	Updated data: 4‑HNE predictive of survival; elevated at diagnosis; FDA discussion	Building evidence; regulatory engagement
Partnerships – Dr. Reddy’s	—	Exclusive license in ALS; up to $733M milestones + royalties	Ongoing discussions for additional indications outside ALS	Platform partnering optionality expanding

Management Commentary

“We expanded our clinical pipeline with our lead asset COYA 302 beyond the initial indication of ALS and into FTD, Parkinson’s, and Alzheimer’s diseases” – Howard Berman, Ph.D., CEO .
“We expect to report clinical progress… we expect to file the IND for COYA 302 in 2Q24 and subsequently initiate the Ph. 2 trial [in ALS]… [and] are in discussions with the FDA about the inclusion of 4‑HNE in the expected Ph. 2 trial” .
“Our cash and cash equivalents balance of $36.0 million provides us a runway into 2026… We continue to have discussions about additional commercial partnerships and license opportunities for COYA 302 in other indications” .

Q&A Highlights

No Q1 2024 earnings call transcript or Q&A was available in our document set; no call-based guidance clarifications or tone changes to report [ListDocuments results; 0 transcripts].

Estimates Context

S&P Global consensus estimates for Q1 2024 could not be retrieved due to a daily request limit exceeded error, so comparisons to Street expectations are unavailable at this time [GetEstimates error].
With collaboration revenue of $0.127M and increased R&D/G&A investments, the quarter’s loss widened year over year, but Street revisions will likely hinge on execution of IND filings and upcoming AD Phase 2 data rather than near-term revenues .

Key Takeaways for Investors

Clinical catalyst stack is robust: ALS IND in 2Q24 with Ph. 2 initiation thereafter; FTD IND in 2H24; AD Phase 2 LD IL‑2 topline Summer 2024; PD animal data in 2H24 – these are the primary stock catalysts .
Biomarker strategy strengthens ALS read-through: 4‑HNE correlates with progression/survival, with updated data predictive of survival and potential inclusion in Ph. 2 design after FDA discussions .
Platform optionality: COYA 302 expansion into FTD/PD/AD and partnering optionality beyond ALS; Dr. Reddy’s deal provides external validation and long-tail economics (up to $733M milestones plus royalties) .
Balance sheet runway: $36.0M cash supports operations into 2026, enabling measured negotiation posture and sustained R&D execution .
Operating spend ramp is intentional: R&D and G&A increases reflect portfolio advancement; monitor burn trajectory relative to clinical timelines and partnering milestones .
Near-term P&L is secondary to clinical execution: collaboration revenue remains small; investor focus should stay on upcoming data reads and IND progress .
Watch for AD data implications: Summer 2024 LD IL‑2 results will inform COYA 302 design in AD and could broaden investor conviction across neurodegenerative indications .

Coya Therapeutics, Inc. (COYA)·Q1 2024 Earnings Summary