Executive Summary

Q1 2025 focused on execution: VELA Phase 3 in HS fully enrolled with patient baseline characteristics mirroring Phase 2 MIRA; management narrowed the primary endpoint timing to “around September 2025,” a potential near-term catalyst . Cash and short-term investments were $480.1M at quarter-end, bolstered post-period by a non-dilutive debt facility of up to $500M (with $75M drawn), extending cash runway into 2028 .
Operating loss widened year over year on stepped-up R&D and G&A to support Phase 3 programs and financing preparation; net loss was $40.6M (vs. $14.0M in Q1 2024) and diluted EPS was $(0.63) (vs. $(0.22) in Q1 2024) .
Management highlighted additional pipeline progress: initiation of VELA-TEEN (adolescent HS), LEDA (PPP) interim readout presented, and S-OLARIS (axSpA) underway; IZAR Phase 3 in PsA continues to advance .
Consensus estimates from S&P Global were unavailable for Q1 2025; we therefore cannot quantify beats/misses vs Street for EPS or revenue (see Estimates Context) [GetEstimates Q1 2025 returned no values]*.

What Went Well and What Went Wrong

What Went Well

Completion of HS Phase 3 VELA enrollment with baseline characteristics replicating Phase 2 MIRA—raises confidence heading into the primary endpoint readout “around September 2025” .
Strengthened balance sheet and extended runway: ended Q1 with $480.1M cash and securities; secured up to $500M non-dilutive debt (drew $75M at close), extending runway into 2028 .
Positive development momentum: interim LEDA (PPP) readout presented; multiple trials initiated/advancing across dermatology and rheumatology, indicating broad optionality for sonelokimab .

Quote: “Having enrolled our Phase 3 VELA program with a patient population that mirrors our Phase 2 MIRA trial further increases our confidence in the primary endpoint data which we expect to present around September 2025.” — CFO, Matthias Bodenstedt .

What Went Wrong

Higher OpEx with scale-up: R&D of $36.5M and G&A of $11.0M (vs $13.0M and $6.8M in Q1’24), reflecting clinical trial execution, personnel growth, and legal/advisory fees for the facility—driving larger YoY losses .
Net loss of $40.6M vs. $14.0M a year ago; diluted EPS $(0.63) vs. $(0.22) in Q1’24; other income helped, but was insufficient to offset OpEx step-up .
Introduction of long-term debt ($73.0M) to the balance sheet reflects new leverage, albeit with favorable terms per company framing; interest expense was modest in the quarter .

Financial Results

Metric	Q3 2024	Q4 2024	Q1 2025
R&D Expense ($M)	$35.74	$40.36	$36.46
G&A Expense ($M)	$7.38	$9.22	$11.03
Total Operating Expenses ($M)	$43.11	$49.58	$47.49
Operating Loss ($M)	$(43.11)	$(49.58)	$(47.49)
Other Income, net ($M)	$7.09	$3.23	$7.10
Net Loss ($M)	$(36.11)	$(46.40)	$(40.56)
Diluted EPS ($)	$(0.56)	$(0.72)	$(0.63)
Cash & ST Investments ($M, end of period)	$493.9	$448.0	$480.1
Long-term Debt ($M, end of period)	—	—	$73.02

Additional YoY context:

Versus Q1 2024: R&D $36.46M vs $13.01M; G&A $11.03M vs $6.81M; Net loss $40.56M vs $13.98M; EPS $(0.63) vs $(0.22) .

KPIs and Operating Metrics

VELA HS Phase 3: Enrollment complete; ~800 patients across VELA-1 and VELA-2; HiSCR75 primary endpoint; readout “around September 2025” .
IZAR PsA Phase 3: Two global trials (IZAR-1, IZAR-2) totaling ~1,500 adults; ACR50 at week 16 primary endpoint; IZAR-2 includes risankizumab active reference arm .
LEDA PPP Phase 2: Interim readout presented; primary endpoint readout expected 2H 2025 .
S-OLARIS axSpA Phase 2: Ongoing open-label PoC with imaging endpoints .
VELA-TEEN Phase 3 (adolescent HS): Initiated early 2025 .

Segment breakdown: Not applicable (clinical-stage, no commercial segments).

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
VELA HS primary endpoint timing	2025	“as of mid-2025”	“around September 2025”	Narrowed/updated timing
Cash runway	Multi-year	“to at least end of 2026”	“into 2028” with $500M facility	Raised runway
LEDA PPP readouts	2025	Trial start around year-end 2024	Interim readout presented; primary endpoint in 2H 2025	Pulled forward/clarified
P-OLARIS (PsA/axSpA) start	2025	Early 2025	Mid 2025	Timing updated
Financing capacity	2025	N/A	Up to $500M non-dilutive, $75M drawn	New facility

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2024, Q4 2024)	Current Period (Q1 2025)	Trend
HS VELA timing/confidence	Primary readout “as of mid-2025”; strong execution	Enrollment completed; baseline characteristics mirror MIRA; readout “around September 2025”	Increased confidence; narrowed timing
Financing runway	Cash to at least end of 2026	$500M facility; runway into 2028	Strengthened liquidity
PPP (LEDA)	Trial start near year-end 2024	Interim readout presented; primary endpoint 2H 2025	Accelerated visibility
PsA (IZAR)	Phase 3 initiation; two trials incl. active reference arm	Program advancing; trials described with ~1,500 target enrollment	Ongoing execution
R&D execution/scale	R&D rising with VELA/IZAR ramp	Continued spend for portfolio; G&A ↑ on personnel and financing legal/advisory	Cost scale aligned to late-stage trials
Macro/regulatory	Sector and regulatory risks noted in FLS	Mentions tariffs/policy shifts in FLS	Continues as risk backdrop

Note: No Q1 2025 earnings call transcript was available in our corpus; themes reflect 8-K and company press releases.

Management Commentary

“Having enrolled our Phase 3 VELA program with a patient population that mirrors our Phase 2 MIRA trial further increases our confidence in the primary endpoint data which we expect to present around September 2025... The non-dilutive facility with Hercules Capital of up to $500 million... extends our projected cash runway into 2028.” — CFO, Matthias Bodenstedt .
Financing partners: “We were able to secure deal terms... highly competitive cost of capital... removes any perceived financing overhang as we approach our pivotal data readout for the HS VELA program this summer.” — CFO, Matthias Bodenstedt (financing PR) .
Strategic intent: CEO emphasized 2025 as data-rich and focused on bringing innovation to patients as commercialization approaches .

Q&A Highlights

No earnings call transcript was available; no Q&A to summarize from company-provided materials. Core clarifications on timing, financing, and program status were provided via 8-K and press releases .

Estimates Context

Consensus (S&P Global) for Q1 2025 EPS and revenue was unavailable at the time of analysis; as a result, we cannot quantify beat/miss vs Street. Management did not provide revenue guidance; company remains pre-commercial [GetEstimates Q1 2025 returned no values]*.

Metric	Q1 2025 Actual	Q1 2025 Consensus	Surprise
Diluted EPS	$(0.63)	N/A*	N/A*
Revenue	N/A (not reported)	N/A*	N/A*

*Values retrieved from S&P Global.

Where estimates may need to adjust: As the VELA HS Phase 3 readout narrows to “around September 2025,” models may shift timing for potential filing/launch scenarios and adjust opex/financing assumptions given the $500M facility and runway into 2028 .

Key Takeaways for Investors

Near-term catalyst: HS VELA primary endpoint readout “around September 2025,” with baseline comparability to MIRA increasing confidence in outcome; positive readout would be stock-moving .
Balance sheet de-risked: $480.1M cash/securities plus up to $500M facility ($75M drawn) extends runway into 2028, mitigating financing overhangs into pivotal data and potential pre-commercial investments .
Portfolio breadth: Multiple active programs (HS, adolescent HS, PPP, PsA, axSpA) create diversified paths to value; LEDA interim already presented; primary endpoint in 2H 2025 .
Investment trade-off: Elevated OpEx (R&D and G&A) necessary for late-stage execution drove larger YoY losses; however, net loss improved sequentially vs Q4 2024 .
Competitive/market validation: Continued success of IL-17 class in inflammatory diseases supports sonelokimab’s commercial opportunity if efficacy/label are compelling .
Timeline watch items: P-OLARIS timing updated to mid-2025; monitor for enrollment progress and any regulatory feedback that could affect development or launch sequencing .
Risk framework: Regulatory, enrollment, macro/tariff and policy shifts noted in forward-looking statements; financing terms appear favorable, but leverage introduces new balance sheet considerations .

Appendix: Source Documents

Q1 2025 Form 8-K and attached press release and financial statements .
Q1 2025 earnings press release (duplicative content) -.
Financing press release (April 3, 2025) .
Capital Markets Day announcement (April 25, 2025) .
Prior quarter 8-Ks (Q4 2024; Q3 2024) for trend analysis - -.

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