Executive Summary

Q4 2024 GAAP net loss was $12.1M (vs. $6.7M YoY), with GAAP EPS of $(0.18); cash, cash equivalents and marketable securities ended at $52.0M, supporting runway into Q1 2026 .
On S&P Global consensus, “Primary EPS” actual was $(0.14)* vs. $(0.12)* estimated (slight miss), and revenue was immaterial/zero versus a $0 consensus estimate*, consistent with the company’s pre‑revenue stage *.
Pipeline execution advanced: AD Phase 1 Cohort 1–2 showed positive efficacy/safety; Cohort 3 nearing completion with data from Cohorts 1–3 planned in May 2025; ALPS Phase 2 initiated with NIAID; PTCL Phase 3 enrollment ongoing; solid tumor Phase 2 start guided to Q3 2025 .
Non‑cash fair value changes in warrant liability ($2.3M loss in Q4) and Angel Pharma equity method losses ($2.2M in Q4) impacted GAAP results; early warrant exercises in Q4 delivered $18.6M cash, with ~$41M additional potential if remaining warrants are exercised .

What Went Well and What Went Wrong

What Went Well
- Positive AD signal and clean safety at low doses: 26% IGA 0/1 and 37% EASI‑75 across Cohorts 1–2 at 28 days; no significant safety or lab abnormalities; no IGA 0/1 or EASI‑75 in placebo .
- Management confidence on ITK mechanism breadth and durability across immune diseases and cancer; clear plan to present Cohorts 1–3 in May and full dataset in Q3 2025 .
- Liquidity strengthened: $52.0M year‑end cash and $18.6M from early warrant exercise; runway into Q1 2026 provides time for key 2025–2026 readouts .
What Went Wrong
- Slight EPS miss vs S&P consensus on “Primary EPS” (actual $(0.14)* vs $(0.12)) despite GAAP EPS of $(0.18); non‑cash items (warrant fair value loss $2.3M; Angel equity loss $2.2M) weighed on results .
- Some program timelines pushed: solid tumor Phase 2 now Q3 2025 (was early 2025); AD full dataset now guided to Q3 2025 (was 1H25) .
- R&D spending rose with soquelitinib trials (Q4 R&D $6.0M vs $4.0M YoY), increasing quarterly cash burn as programs scale .

Financial Results

GAAP operating profile and losses (USD Millions; per‑share in USD). Periods are oldest → newest.

Metric	Q4 2023	Q2 2024	Q3 2024	Q4 2024
Research & Development ($)	$4.0	$4.1	$5.2	$6.0
General & Administrative ($)	$1.7	$1.8	$2.0	$2.1
Total Operating Expenses ($)	$5.7	$5.9	$7.3	$8.1
Net Loss ($)	$(6.7)	$(4.3)	$(40.2)	$(12.1)
Net Loss per Share ($)	$(0.14)	$(0.07)	$(0.60)	$(0.18)

Liquidity and capital structure (USD Millions; shares units):

Metric	Q4 2023	Q3 2024	Q4 2024
Cash, Cash Equivalents & Marketable Securities ($)	$27.1	$41.7	$52.0
Warrant Liability ($)	—	$40.0	$28.9
Cash Runway Guidance	—	Into 2026	Into Q1 2026
Shares Used (Basic & Diluted)	49.0M	66.7M	68.3M

Q4 2024 results vs S&P Global consensus (Q4 2024):

Metric	Consensus	Actual
Primary EPS (S&P)	$(0.12)*	$(0.14)*
Revenue ($)	$0.0*	$0.0*

Values marked with * are retrieved from S&P Global.

Key P&L drivers and items:

Non‑cash warrant fair value change: $(2.347)M in Q4; Angel Pharma equity method loss: $(2.174)M in Q4 .
Early warrant exercises provided ~$18.6M cash in Q4; ~$41M additional potential if all remaining are exercised (exercise price $3.50; expire Jun 30, 2025) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Multi‑year	Into 2026 (Q3 2024)	Into Q1 2026 (Q4 2024)	Maintained/clarified
AD Phase 1 Data (Cohorts 1–3)	Q2 2025	Interim Dec 2024; final all four cohorts 1H25 (Q3 2024)	Cohorts 1–3 in May 2025; full dataset Q3 2025	Pushed
Solid Tumor Phase 2 Start (Soquelitinib)	2025	Early 2025 (Q3 2024)	Q3 2025	Pushed
PTCL Phase 3 Enrollment / Interim Timing	2025–2026	Enrolling, on track (Q3 2024)	Enrolling; interim data late 2026	New timing disclosed
ALPS Phase 2 (with NIAID)	2025	Not initiated (Q3 2024)	Initiated March (under CRADA); up to 30 pts; 200/400 mg BID; up to 360 days	New

Earnings Call Themes & Trends

Topic	Q2 2024 (Q‑2)	Q3 2024 (Q‑1)	Q4 2024 (Current)	Trend
AD efficacy/safety signal	Early AD activity at 100 mg BID; clean labs; interim planned Q4’24	Trial advancing; Cohort 1 complete; Dec readout planned	Cohorts 1–2: 26% IGA 0/1, 37% EASI‑75; Cohort 3 nearing completion; biomarkers planned	Improving
PTCL Phase 3	Moving toward start; P3 initiation targeted Q3’24	P3 enrolling; ~40–50 sites planned US/AU/CA/KR	Enrollment ongoing; interim data late 2026	Steady execution
Solid tumor expansion	Planned launch in early 2025	Still targeting early 2025	Start shifted to Q3 2025; initial data 1H 2026	Pushed
ALPS (autoimmune)	Not yet disclosed	Interest in autoimmune potential, mechanism durability	Phase 2 initiated with NIAID; 200/400 mg BID; up to 30 pts	Expanding
Biomarkers/Mechanism	Th17→Treg switch data (Cornell); durable anti‑inflammatory potential	Plan to report cytokines; rapid onset in AD	Biomarkers at May meeting; durability and Treg effects emphasized	Building evidence
Cash/warrants	Cash $47.2M (Q2); runway into Q4’25	Cash $41.7M; runway into 2026; $5.9M warrant exercise	Cash $52.0M; runway into Q1’26; $18.6M warrant exercise; $41M potential remaining	Strengthened

Management Commentary

“We continue to advance our selective ITK inhibitor, soquelitinib, in a range of diseases… AD Phase 1 is nearing completion of enrollment in the third cohort… PTCL Phase 3 is enrolling… initiated a Phase 2 in ALPS… We now anticipate initiating [solid tumor] in the third quarter 2025.” – Richard A. Miller, CEO .
“In AD, Cohorts 1 and 2 showed a favorable safety and efficacy profile with significant responses vs placebo on IGA 0/1 and EASI‑75; Cohort 3 (200 mg BID) is nearing completion; full data for Cohorts 1–3 planned for May.” .
“Our current cash gives us runway into the first quarter of 2026, allowing us to execute on these important milestones.” .
On comparative positioning: “To my knowledge, we're the only selective ITK inhibitor… others are not selective; we view that as critical.” .

Q&A Highlights

AD data and bar for success: Full datasets for Cohorts 1–3 in May; efficacy difference vs placebo of ~25–35% on key endpoints at 28 days viewed as “pretty good,” with potential to improve with longer dosing .
Dosing strategy & Cohort 4: Decision on 400 mg QD pending Cohort 3 review; strong receptor occupancy achieved across 100–400 mg; potential to explore longer treatment duration .
Patient mix: Cohort 3 includes sicker patients, more Dupixent/systemic failures, and higher baseline EASI; effect by prior biologic failure not yet known .
Biomarkers: Expect to report cytokines and T‑regulatory cell findings in May; early signals are “very provocative” .
ALPS opportunity: Estimated ~2,500 U.S. patients; rationale grounded in ITK biology and murine models; long‑term oral therapy plausible with current safety profile .
Solid tumor plan: Start with immune‑responsive tumors (RCC, lung); no classic dose escalation needed, will look at multiple doses; strong PD marker (ITK saturation) informs dose selection .

Estimates Context

S&P Global Q4 2024 consensus and actual: “Primary EPS” $(0.12)* consensus vs $(0.14)* actual (miss of ~$0.02); revenue consensus $0.0* and actual $0.0*, consistent with pre‑revenue status. Values retrieved from S&P Global.*
Reported GAAP EPS was $(0.18) as per the company’s statement of operations; differences vs “Primary EPS” reflect methodology and the impact of non‑cash items (e.g., warrant fair value change, equity method losses) .
Implication: Near‑term estimate revisions likely focus on R&D cadence, timing of AD Phase 1 full dataset (Q3 2025), solid tumor program push to Q3 2025, and runway clarity to Q1 2026 .

Key Takeaways for Investors

Readout cadence is the stock driver: AD Cohorts 1–3 at SID in May 2025, full AD Phase 1 dataset in Q3 2025; ALPS Phase 2 now active (first data likely 2026); PTCL Phase 3 continues with interim targeted late 2026 .
Selective ITK differentiation narrative is intact and emphasized across AD, oncology, and autoimmune indications; potential class‑defining strategy if Phase 3/PTCL and AD datasets deliver .
Solid tumor program delay to Q3 2025 modestly shifts 2026 optionality; risk‑reward remains centered on AD efficacy durability and P3 oncology execution .
Cash runway into Q1 2026 plus $41M potential warrant proceeds provide flexibility through key 2025 milestones, reducing near‑term financing overhang .
Non‑cash P&L items (warrant and equity method) can obscure operating trends; focus on R&D trajectory and clinical catalysts for trading setups .
For trading: May SID AD data is the next identifiable catalyst; magnitude and durability of EASI/IGA improvements and biomarker readouts will shape sentiment into the Q3 2025 full dataset .