Executive Summary

Q4 2022 net loss was $11.9M and diluted EPS was $0.92; full-year 2022 net loss was $43.8M and diluted EPS was $3.38, with the year-over-year increase driven by advancement of clinical programs .
The company aligned Phase 3 design for vurolenatide (SBS) post-FDA comments: 24-week duration for both subgroups, continuous variable endpoints, approximately 120 patients, interim analysis at 50% completion—positioning for pivotal efficacy readouts .
Liquidity tightened: cash and cash equivalents fell to $29.7M at 12/31/22 (from $39.4M at 9/30/22 and $29.5M at 6/30/22), but subsequent amendments released ~$16.8M of restricted cash and a $5M equity raise extended runway into Q3 2023 .
Potential stock catalysts: Phase 3 VIBRANT 2 enrollment progress, interim analysis, and clinical conference presentations (ASPEN, DDW) on vurolenatide/NM-136 .

What Went Well and What Went Wrong

What Went Well
- VIBRANT Phase 2 final data showed strong efficacy: 30% TSO reduction on vurolenatide vs 32% increase on placebo (mean relative reduction 62%), with rapid onset and sustained response on Q2W dosing; vurolenatide broadly targets SBS beyond PS-dependent patients .
- FDA alignment on Phase 3 protocol (VIBRANT 2) with robust design (continuous endpoints, 24 weeks, ~120 patients), enhancing likelihood of clinically meaningful readouts .
- Management reaffirmed conviction in vurolenatide’s potential to become a new standard of care in SBS, citing full patient population coverage and convenient dosing .
What Went Wrong
- Net loss increased year over year (FY 2022 $43.8M vs FY 2021 $36.8M) as clinical programs advanced, pressuring cash resources in a challenging small-cap biotech financing environment .
- Q4 2022 net loss of $11.9M and diluted EPS of $0.92 reflect continued spend ahead of pivotal trials without revenue offset .
- Program rationalization earlier in 2022 (larazotide for celiac disease discontinued) underscores pipeline risk; while it lowered Q3 2022 loss vs prior year, it removed a potential future revenue stream .

Financial Results

Quarterly trends and liquidity

Metric	Q2 2022	Q3 2022	Q4 2022
Net Loss ($USD Millions)	$11.1	$9.4	$11.9
Diluted EPS ($USD)	$0.04 (pre-split); $0.80 post-split derived via 1-for-20 split	$0.72 (post-split; $0.04 pre-split)	$0.92
Cash & Cash Equivalents (Period-End) ($USD Millions)	$29.5	$39.4 (incl. $23.5M restricted)	$29.7 (incl. $17.0M restricted)
Cash Runway Commentary	Runway into 4Q 2023 pro forma with $20M draw	Runway into H2 2023	Runway into Q3 2023; $16.8M restricted cash released post-year-end; $5M equity raise

Year-over-year EPS comparison

Metric	Q4 2021	Q4 2022
Diluted EPS ($USD)	$0.04 pre-split; $0.80 post-split	$0.92

Notes: The company did not disclose product revenues or margin metrics in the Q4 press release; as a clinical-stage biotech, no product revenue was reported in the releases reviewed .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	As of Q2 2022	Into 4Q 2023 (pro forma with $20M draw)	Into Q3 2023; ~$16.8M restricted cash repaid; $5M equity raise	Lowered (timing), liquidity actions taken
Phase 3 Initiation (Vurolenatide)	2H 2022	“As early as 4Q 2022” pending EoP2	Protocol finalized; aligned with FDA; VIBRANT 2 to enroll ~120 patients, 24-week duration, continuous endpoints	Clarified design, timelines refined
Study Endpoints & Duration (VIBRANT 2)	2022 Planning	Dual primary endpoints across PS subgroups	Confirmed continuous variable endpoints; 24-week duration for both subgroups; interim at 50%	Refined (strengthened design)
Operating Expenses	FY 2022 vs FY 2021	N/A in releases	FY net loss increased due to program advancement	Higher spend (development-driven)

Earnings Call Themes & Trends

(No Q4 2022 earnings call transcript was found; we searched earnings-call-transcript documents 3/1/2023–4/30/2023 and none were available. We relied on press releases and 8-Ks.)

Topic	Previous Mentions (Q2 2022)	Previous Mentions (Q3 2022)	Current Period (Q4 2022)	Trend
Regulatory/FDA Alignment	EoP2 meeting on track for Q3	EoP2 completed; planning for Phase 3	FDA comments received; protocol aligned (continuous endpoints, 24 weeks)	Progressing to pivotal
R&D Execution (Vurolenatide)	Positive preliminary Phase 2 results; Phase 3 planning	Final Phase 2 results confirm efficacy/safety; dose/regimen Q2W	VIBRANT 2 design finalized; ~120 patients; interim analysis	Advancing
Patient Population Strategy	Target full SBS population incl. non-PS patients	Emphasis on addressing all SBS patients (GLP-1 vs GLP-2 class)	Study design tailored to PS-dependent and non-PS subgroups	Consistent, reinforced
Financing & Liquidity	$70M convertible note facility; $20M initial draw	Cash runway into H2 2023; $23.5M restricted cash	~$16.8M restricted cash repaid; $5M direct offering; runway into Q3 2023	Tightening but managed
Portfolio Rationalization	Larazotide Phase 3 discontinued (cedlara)	Lower Q3 net loss vs PY due to discontinuation	Focus narrowed to vurolenatide; preclinical NM-136/NM-102 advancing	Focused pipeline
External Visibility	Anticipated data at conferences	—	ASPEN (April) & DDW (May) presentations accepted	Increasing visibility

Management Commentary

“Our priority for 2023 remains to progress our Phase 3 vurolenatide program for short bowel syndrome including securing a clinical development and commercialization partner.” — John Temperato, President & CEO .
“We firmly believe vurolenatide can establish a new standard of care… address the full SBS patient population… rapid onset of action, sustained response, and a potentially convenient dosing regimen.” — John Temperato .
“The successful completion of the VIBRANT study was a key milestone… vurolenatide is the first GLP-1 agonist being developed specifically for SBS… decrease in both total stool output and parenteral support volume… every two-week dosing regimen.” — John Temperato .
“The current financial markets… have been challenging… we have… strengthened our balance sheet with an equity financing and… implemented cost-saving measures to further our cash runway.” — Management commentary .

Q&A Highlights

No Q4 2022 earnings call transcript was available; we searched for earnings-call-transcript documents and found none for the period. Guidance clarifications were provided via press release (FDA protocol alignment, endpoints, duration, enrollment, interim analysis) .

Estimates Context

Wall Street consensus (S&P Global) for Q4 2022 EPS and revenue was unavailable due to missing CIQ mapping for NMTRQ in SPGI’s company map, preventing retrieval via our estimates tool [GetEstimates error]. Given the lack of product revenue disclosures in press releases, investor comparisons to consensus are not feasible in this case .

Financial KPIs and Clinical Metrics

KPI	Q2 2022	Q3 2022	Q4 2022
Vurolenatide Dose/Regimen	Candidate dose identified; planning Q2W	50 mg Q2W selected for Phase 3	50 mg Q2W confirmed; two primary endpoints
TSO Efficacy vs Placebo	Positive prelim efficacy (not quantified in Q2 PR)	−30% TSO on drug vs +32% placebo (mean relative −62%)	Design aligns to continuous endpoints to capture efficacy
Parenteral Support Volume	—	Mean −17% by week 2; sustained; 3/5 patients −28%	Phase 3 includes PS-dependent and non-PS subgroups
Phase 3 Design	Planning to initiate as early as 4Q22	CRO engaged; sites recruiting	24-week duration; ~120 pts; interim at 50%; continuous endpoints

Guidance Changes — Details and Rationale

Liquidity outlook: runway shifted from 4Q 2023 (pro forma) to Q3 2023 as cash fell and restricted cash decreased; mitigated by releasing ~$16.8M restricted cash post-year-end and a $5M equity raise, alongside cost-reduction measures .
Program timing/design: FDA comments led to continuous endpoints and uniform 24-week duration, improving statistical robustness and clinical relevance; interim analysis introduced for operational efficiency .
Spend profile: higher FY 2022 net loss tied to accelerated clinical development, signaling prioritization of pivotal program execution .

Key Takeaways for Investors

Vurolenatide’s differentiated GLP-1 mechanism and Phase 2 efficacy signal (TSO reduction, PS volume decrease) support the Phase 3 risk-reward, with broad applicability across SBS patients including non-PS .
Phase 3 protocol alignment with FDA (continuous endpoints, 24 weeks, ~120 pts, interim) improves trial rigor and potential for clear efficacy demonstration—critical for regulatory and commercial outcomes .
Liquidity remains the primary overhang; runway into Q3 2023 with recent actions (restricted cash release, $5M raise, cost cuts) helps bridge to near-term milestones but may necessitate additional capital/partnering .
No revenue disclosure and consensus datapoints unavailable limit traditional “beat/miss” framing; focus shifts to clinical execution cadence (enrollment, interim analysis) and partnering progress .
Discontinuation of larazotide narrowed focus and reduced spend in Q3 vs PY, but underscores pipeline concentration—execution on vurolenatide is paramount .
Near-term catalysts: ASPEN/DDW presentations, Phase 3 site activation/enrollment updates, potential partnership announcements—each can move sentiment and stock .
Medium-term thesis centers on the potential to serve the full SBS population, convenience of Q2W dosing, and health-economic implications if PS reduction is confirmed in Phase 3, driving adoption and payer interest .

9 METERS BIOPHARMA, INC. (NMTRQ)·Q4 2022 Earnings Summary