9 METERS BIOPHARMA, INC. (NMTRQ)·Q3 2022 Earnings Summary

Executive Summary

• Q3 2022 focused on clinical execution: positive final Phase 2 VIBRANT results for vurolenatide in short bowel syndrome (SBS) and End-of-Phase 2 FDA meeting set up Phase 3 initiation; net loss narrowed as Opex shifted away from discontinued larazotide in celiac disease .
• Reported net loss of $9.4M and $0.72 EPS ($0.04 pre-split basis), improving from Q3 2021’s $13.5M loss and $1.06 EPS ($0.05 pre-split); cash and cash equivalents were $39.4M, including $23.5M restricted cash .
• Financing runway extended via $21M gross initial draw on a $70M senior secured convertible notes facility; company expects runway into 2H 2023, contingent on capital access .
• Corporate actions and near-term catalysts: 1-for-20 reverse split executed to regain Nasdaq compliance (Oct 17) and Phase 3 VIBRANT 2 design announced (Nov 29) with two co-primary endpoints and up to 50 sites, targeting study initiation as early as end-of-year .

What Went Well and What Went Wrong

What Went Well

• Positive final Phase 2 data: vurolenatide 50mg Q2W achieved a 30% decrease in mean 24-hour total stool output (TSO) vs a 32% increase on placebo (62% relative reduction), with rapid onset and sustained response; vurolenatide generally well tolerated .
• Constructive End-of-Phase 2 FDA meeting; protocol finalization planned in Q4 with activities underway to enable Phase 3 initiation shortly thereafter. “We look forward to finalizing protocol details in the fourth quarter and plan to initiate the Phase 3 program shortly thereafter” — John Temperato, CEO .
• Liquidity improved: cash increased to $39.4M (incl. $23.5M restricted) with initial draw of $21M gross under a $70M notes facility; stated runway into 2H 2023 .

What Went Wrong

• Larazotide discontinued after Phase 3 interim analysis in celiac disease, eliminating a co-lead asset and concentrating pipeline risk on vurolenatide .
• Continued listing risk required a 1-for-20 reverse split to address sub-$1 bid price; Nasdaq granted compliance extension to Feb 6, 2023, underscoring listing pressure .
• Capital dependence persists: future access to the remaining $50M of the notes facility is conditioned on raising additional capital; forward-looking statements emphasize funding uncertainties .

Financial Results

Quarterly P&L and Liquidity

Notes:

• No product revenues were disclosed; as a clinical-stage company, margin metrics are not applicable .
• Financing: $21M gross initial draw from a $70M senior secured convertible notes facility on July 15; ability to access up to $50M more in tranches, subject to requirements including raising additional capital .

Year-over-Year (Q3)

Capital Structure Snapshot

Clinical KPIs (VIBRANT Phase 2)

Guidance Changes

Earnings Call Themes & Trends

No Q3 2022 earnings call transcript was available; themes summarized from company press releases.

Management Commentary

• “Vurolenatide is the first GLP-1 agonist being developed specifically for SBS... The unique mechanism of action, as observed in the VIBRANT study, resulted in a decrease in both total stool output and parenteral support volume with a rapid onset of action, sustained response, and an every two-week dosing regimen.” — John Temperato, CEO .
• “Based on the outcome of [the End-of-Phase 2] meeting and the Phase 2 data, the Company intends to finalize the Phase 3 protocol during the fourth quarter of 2022.” .
• “As of September 30, 2022, the Company's cash and cash equivalents totaled approximately $39.4 million, of which $23.5 million was restricted cash... The Company anticipates that its cash runway is sufficient to fund the ongoing clinical programs into the second half of 2023.” .
• “Following thorough analysis of the CedLara® Phase 3 study interim data, we are discontinuing further development of larazotide in celiac disease.” .

Q&A Highlights

No Q3 2022 earnings call transcript or Q&A session was found for NMTRQ in the available document set; analysis reflects press releases and 8-K filings .

Estimates Context

• Wall Street consensus (S&P Global) for Q3 2022 EPS and revenue was unavailable due to missing SPGI/CIQ mapping for NMTRQ in our estimates feed; therefore, estimate comparisons cannot be provided in this recap. If and when mapping is restored, we will incorporate “Primary EPS Consensus Mean” and “Revenue Consensus Mean” for the period and assess beats/misses (currently unavailable).
• With larazotide discontinued and Phase 3 vurolenatide moving forward, analysts may need to recalibrate Opex, timelines, and probability of success assumptions for SBS and remove celiac-related valuation components .

Key Takeaways for Investors

• Clinical de-risking: robust Phase 2 data and EOP2 alignment support Phase 3 initiation; the dual-endpoint Phase 3 design (TSO and PS) may broaden approvability across SBS subpopulations .
• Focused pipeline: discontinuation of larazotide concentrates resources on vurolenatide; execution risk centralizes in a single late-stage asset .
• Financing runway extended but contingent: initial $21M draw and restricted cash underpin runway into 2H 2023; access to additional tranches requires capital raises, a key watch item .
• Listing risk mitigated: reverse split addressed bid price compliance; monitor continued Nasdaq status through the Feb 2023 extension window .
• Near-term catalysts: Phase 3 site activation and patient enrollment, protocol finalization updates, and potential early readouts on operational progress could drive sentiment .
• Commercial positioning: if Phase 3 confirms reductions in TSO and PS, vurolenatide could address the majority of SBS patients (including non-PS-dependent), differentiated from GLP-2 analogs limited to PS-dependent patients .
• Risk factors: funding, trial execution in a rare disease across global sites, and regulatory clarity on endpoints; watch for updates and interim analyses (PS-dependent subgroup) .