Executive Summary

Pre-revenue clinical-stage quarter; net loss widened to $62.3M and EPS to $(1.77) as Disc accelerated commercialization and clinical spend, while ending Q3 with $615.9M in cash, cash equivalents, and marketable securities .
Submitted the bitopertin NDA on Sep 29 and received the FDA Commissioner’s National Priority Voucher, targeting a potentially accelerated U.S. approval decision in late 2025/early 2026; APOLLO confirmatory trial enrollment ongoing .
Initial Phase 2 data in MF anemia (DISC-0974) expected by year-end; Phase 2 PV (DISC-3405) ongoing and Phase 1b SCD initiated in October with initial data expected in 2026, broadening the hematology pipeline .
Cash runway extended into 2029 after an October financing, reducing financing overhang and supporting pivotal development and launch readiness for bitopertin .

What Went Well and What Went Wrong

What Went Well

Bitopertin regulatory momentum: NDA filed and CNPV granted, enabling 1–2 month review post-acceptance; management is accelerating commercial readiness for a potential late-2025/early-2026 launch .
“Achieving this milestone is a strong testament to our team’s commitment to execution…bringing a potential new treatment option to the EPP patient community.” — CEO John Quisel .
Pipeline breadth sustained: Phase 2 MF anemia data (DISC-0974) slated for year-end; PV Phase 2 (DISC-3405) ongoing and SCD Phase 1b initiated; clear multi-indication strategy across iron/heme biology .
Liquidity buffer strengthened: $615.9M at Q3-end and ~$211M net proceeds in Oct, extending cash runway into 2029 to fund development and launch .

What Went Wrong

Higher operating costs: R&D rose to $50.3M and SG&A to $17.4M, reflecting milestones and commercialization build-out; net loss increased YoY and sequentially as spend scaled .
CKD program variability: Non-dialysis CKD anemia Phase 1b showed mechanism engagement but hemoglobin increases occurred only in a subset (linked partly to higher baseline EPO), prompting reassessment of program path .
No earnings call transcript was available; absence limits direct visibility into Q&A clarifications; reliance on press release and filings for narrative [functions.ListDocuments earnings-call-transcript=0] .

Financial Results

Metric	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Revenue ($USD Millions)	N/A (pre-revenue)	N/A (pre-revenue)	N/A (pre-revenue)	N/A (pre-revenue)
Net Loss ($USD Millions)	$26.6	$34.1	$55.2	$62.3
EPS (Basic & Diluted, $)	$(0.89)	$(1.02)	$(1.58)	$(1.77)
Total Operating Expenses ($USD Millions)	$32.9	$39.9	$61.4	$67.7

Operating expense detail:

Operating Expense ($USD Millions)	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Research & Development	$24.7	$27.8	$46.3	$50.3
Selling, General & Administrative	$8.2	$12.2	$15.1	$17.4

KPIs:

KPI	Q1 2025	Q2 2025	Q3 2025
Cash, Cash Equivalents & Marketable Securities ($USD Millions)	$694.7	$650.0	$615.9
Weighted-Average Shares (Basic & Diluted)	33.3M	35.0M	35.2M

Segment/program expense (company reports a single segment; values as presented in segment table):

Program/Category ($USD Millions; company presentation shows expenses as negatives)	Q3 2024	Q3 2025
Bitopertin program external expense	$(7.261)	$(11.833)
DISC-0974 program external expense	$(5.671)	$(7.369)
DISC-3405 program external expense	$(3.254)	$(11.910)
Other external R&D	$(1.233)	$(4.095)
Internal & other R&D	$(5.586)	$(10.704)
Commercial expense	$(0.555)	$(3.928)
General & administrative	$(4.964)	$(8.343)
Stock-based compensation	$(4.332)	$(9.514)
Other segment items (income)	$6.257	$5.375

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Corporate	“Into 2028” (Q2 2025 PR)	“Into 2029” post Oct offering (Q3 2025 PR; 10-Q subsequent events)	Raised
Bitopertin NDA review timeline	U.S.	On track to submit Oct 2025 (Q2 PR)	CNPV granted; expected 1–2 month review from acceptance; potential approval late 2025/early 2026 (Q3 PR; investor presentation)	Accelerated
MF anemia (DISC-0974) data cadence	Program	Initial Phase 2 data “H2 2025” (Q2 PR)	Initial data “by year end” and topline in 2026 (Q3 PR)	Clarified timing
SCD Phase 1b (DISC-3405)	Program	Initiation “by year end” (Investor materials)	Initiated Oct 2025; initial data 2026 (Q3 PR)	Initiated

Earnings Call Themes & Trends

(Note: No formal earnings call transcript was available. Themes reflect press releases and investor presentation.)

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3 2025)	Trend
Bitopertin regulatory path	APOLLO confirmatory trial initiated; pre-NDA alignment (Q1/Q2 PRs)	NDA filed; CNPV granted; accelerated review 1–2 months; potential approval late 2025/early 2026	Accelerating
MF anemia (DISC-0974)	Phase 2 ongoing; initial data H2 2025	Initial data confirmed “by year end”; topline 2026	On schedule
CKD anemia (DISC-0974)	Multiple-dose data expected H2 2025	Mechanism engaged; variable Hb; options under assessment; full data at ASN Kidney Week	Reassessing
PV & SCD (DISC-3405)	PV Phase 2 initiated H1 2025; SCD planned by year end	PV Phase 2 ongoing; SCD Phase 1b initiated Oct; initial data 2026	Executing
Cash runway	Into 2028 (Q1/Q2)	Into 2029 after Oct offering	Strengthened

Management Commentary

“We continue to work with the Agency on their review of our application, and we are furthering our commercial infrastructure in preparation for a potential launch.” — John Quisel, CEO .
Investor deck emphasizes accelerated review benefits under CNPV (1–2 month timeline), and urgent focus on access and launch readiness for EPP/XLP .

Q&A Highlights

(No formal earnings call transcript published. Notable clarifications from press/investor materials:)

CKD anemia program: engagement of mechanism with variable hemoglobin; subset responses tied in part to higher baseline EPO; options under assessment pending full data .
MF anemia: initial Phase 2 data by year-end and topline in 2026; potential to discuss registrational path with regulators if positive .
Bitopertin launch readiness: commercial infrastructure build-out underway given CNPV-accelerated timeline .

Estimates Context

S&P Global consensus EPS/revenue estimates for Q3 2025 were unavailable via our data source; as a result, we cannot assess beat/miss versus Street for this quarter (Values retrieved from S&P Global; no data returned).*
Company reported no revenue and EPS of $(1.77) for Q3 2025; comparisons here are to prior periods rather than estimates .

Key Takeaways for Investors

Regulatory catalyst: bitopertin NDA + CNPV materially compresses review, making late-2025/early-2026 U.S. approval plausible if accepted and favorable, a potential inflection for valuation .
Pipeline diversification: MF anemia (near-term data), PV, and SCD programs provide multiple shots on goal beyond EPP/XLP, supporting medium-term growth narrative .
Cash runway into 2029 reduces financing risk through pivotal development and initial commercialization, supporting execution continuity .
Near-term trading setup: regulatory review milestones (NDA acceptance, potential decision) and MF anemia initial Phase 2 data are likely stock-moving events in the coming weeks/months .
CKD program risk-managed: program path being reassessed given variable Hb response; focus staying on indications with stronger clinical signal and clearer regulatory trajectories .
Commercial readiness: SG&A growth reflects infrastructure build for bitopertin; this spend is consistent with accelerated approval timing .

Sources and Prior Quarter References

Q3 2025 press release (Nov 6, 2025) and program updates .
Corporate 8-K and investor presentation update (Oct 20, 2025) .
Q3 2025 10-Q (filed Nov 6, 2025) for financial statements and subsequent events .
Q2 2025 press release and Q2 10-Q .
Q1 2025 press release and Q1 10-Q .

Notes:

No earnings call transcript was available for Q3 2025 via our document tools [functions.ListDocuments earnings-call-transcript=0].
Disc is a single operating segment; program expense detail presented as per segment disclosure.

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