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9M

9 METERS BIOPHARMA, INC. (NMTRQ)·Q1 2023 Earnings Summary

Executive Summary

  • Q1 2023 was dominated by liquidity stress: net loss widened to $13.87M and diluted EPS was ($1.02), with unrestricted cash declining to $6.94M; management disclosed substantial doubt about going concern and entered a forbearance agreement on its convertible note with 18% default interest .
  • Management is “exploring options to fund further advancement” of vurolenatide (SBS) and NM‑136 (anti‑GIP for obesity), including financing and strategic alternatives; a $5M registered direct offering closed March 15, 2023 .
  • Pipeline momentum: FDA pre‑IND feedback received for NM‑136; the company plans to submit an IND in 2H 2023; vurolenatide Phase 3 (VIBRANT‑2) design refined earlier in 2023 with 24‑week duration and continuous endpoint across subgroups (120 patients; interim at 50%) .
  • No earnings call transcript was published in our sources; narrative relies on the 8‑K/press release and the 10‑Q. S&P Global consensus estimates were not available in our feed, so beat/miss versus Street could not be assessed.

What Went Well and What Went Wrong

  • What Went Well

    • FDA pre‑IND feedback for NM‑136 provided clarity on preclinical package and Phase 1 design; plan to submit IND in 2H 2023, sustaining an optionality path in obesity .
    • Vurolenatide program remains the strategic focus; prior Phase 2 data underpinned Phase 3 design aiming to serve full SBS population, including patients not on parenteral support .
    • Management signaled willingness to pursue strategic alternatives and financing to advance programs: “exploring options to fund further advancement… including financing and other strategic alternatives” .
  • What Went Wrong

    • Liquidity deterioration and going‑concern disclosure: unrestricted cash fell to $6.94M; management stated substantial doubt about continuing as a going concern without additional funding .
    • Debt default and forbearance: company was in default under its amended convertible note (Nasdaq listing deficiency); entered a forbearance agreement requiring ~$3.1M partial acceleration and maintaining 18% default interest until further notice .
    • Operating loss expanded YoY as R&D spend pivoted to NM‑136 (obesity) offset by lower spend on vurolenatide post‑Phase 2 and discontinued larazotide; net loss increased to $13.87M (vs. $11.35M) .

Financial Results

MetricQ3 2022Q4 2022Q1 2023
Net Loss ($USD Millions)$9.4 $11.9 $13.87
Diluted EPS ($)($0.72) ($0.92) ($1.02)
Total Cash and Cash Equivalents ($USD Millions)$39.4 (incl. restricted) $29.7 (incl. restricted) $7.62 (cash, cash equivalents and restricted cash)
Restricted Cash ($USD Millions)$23.5 $17.0 $0.68

Q1 2023 P&L detail and YoY mix shift (program-level R&D):

R&D by Program ($USD)Q1 2022Q1 2023
Vurolenatide – SBS$3,826,934 $3,125,601
NM‑136 – Obesity$775,542 $4,817,107
NM‑102 – Orphan$926,495 $43,453
Larazotide – Celiac$1,651,492 $30,261
Other R&D$1,188,015 $1,782,869
Total Operating Expenses (R&D+G&A)$11,364,249 $12,787,491

Cash flows and financing (Q1 2023):

  • Operating cash outflow: ($9.75M) .
  • Financing: $16.75M cash principal paid on convertible note; $5.0M gross proceeds from March 2023 equity/warrants, ~$4.4M net .

KPIs (capital structure/liquidity):

  • Shares outstanding: 14,459,690 (as of May 12, 2023) .
  • Convertible note (current portion net): $5.07M; multiple redemption/convert features and default remedies disclosed .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayFY 2023“Sufficient to fund operations into the third quarter of 2023” (as of Dec 31, 2022) Going‑concern doubt without additional funding; forbearance agreement with default interest 18% Lowered/withdrawn
NM‑136 IND timing2023Pre‑IND meeting in 1H23; potential IND submission 2H23 Plan to submit IND in 2H23 after FDA feedback Maintained
Vurolenatide Phase 3 (VIBRANT‑2)2023+Protocol clarified with FDA; 24‑week duration, continuous variable endpoint; ~120 patients; interim at 50% Development focus reiterated; no new timing in Q1 PR beyond strategic alternatives Maintained narrative; timeline dependent on funding

No revenue/EPS guidance was provided in the company materials reviewed .

Earnings Call Themes & Trends

No Q1 2023 earnings call transcript was available in our sources; themes reflect 8‑K/press release and 10‑Q.

TopicPrevious Mentions (Q3 2022, Q4 2022)Current Period (Q1 2023)Trend
Liquidity/runway; financingCash runway into 2H/late 2023; $70M note facility; equity financing discussed Going‑concern substantial doubt; forbearance on note default; default interest 18% Worsening
Vurolenatide (SBS) clinical pathPhase 2 VIBRANT positive; Phase 3 protocol aligned with FDA (24‑weeks; continuous endpoints) Program remains focus; advancement contingent on funding/strategic alternatives Stable but funding‑dependent
NM‑136 (anti‑GIP) in obesityIND‑enabling work; pre‑IND planned 1H23 FDA feedback received; plan to file IND in 2H23 Improving clarity
Cost actions/opsReverse split; phase program reprioritization ~52% workforce reduction; retention RSUs; cost reduction plan De‑risking cash burn
Capital markets/NasdaqListing maintenance risk flagged; financings ongoing Default tied to Nasdaq listing deficiency; forbearance agreed Worsening

Management Commentary

  • “We are enthusiastic about the potential of vurolenatide and NM‑136 to deliver value to patients. We are exploring options to fund further advancement of these assets, including financing and other strategic alternatives.” — John Temperato, President & CEO .
  • Q4 2022 set the Phase 3 vurolenatide path: “VIBRANT 2 incorporates two primary endpoints… continuous variable endpoint and a 24‑week study duration… Approximately 120 patients… interim analysis when 50% reach 24 weeks” .
  • Strategic posture: continued evaluation of financing, BD and strategic alternatives amid challenging markets for small‑cap pharma .

Q&A Highlights

  • No earnings call/Q&A transcript was available in our sources for Q1 2023; no additional guidance clarifications beyond the 8‑K/press release and 10‑Q .

Estimates Context

  • S&P Global/Capital IQ consensus estimates for Q1 2023 were not available in our feed for NMTRQ; therefore, we cannot assess beat/miss versus Street for revenue or EPS.
  • Reported results: diluted EPS ($1.02) and net loss $13.87M; no product revenue was disclosed in the 10‑Q (statements present operating expenses without a revenue line) .

Key Takeaways for Investors

  • Near‑term thesis hinges on liquidity: going‑concern disclosure, low unrestricted cash ($6.94M), forbearance/default interest at 18%, and need for rapid financing or strategic transaction are the dominant stock catalysts .
  • Debt overhang remains material: amended and restated 2022 convertible note has multiple redemption/convert features; default tied to listing deficiency elevates execution risk .
  • Pipeline optionality persists: NM‑136 has FDA feedback and a 2H23 IND plan; vurolenatide Phase 3 design is FDA‑aligned but requires funding and/or partnership to progress .
  • Expense mix shifting: significant reallocation toward NM‑136 ($4.82M in Q1 vs $0.78M prior year), with lower spend on vurolenatide post‑Phase 2; watch R&D cadence vs. cash runway .
  • Cost actions partially mitigate burn (52% workforce reduction; retention RSUs), but runway remains constrained absent new capital or BD .
  • No formal financial guidance or call transcript; trading likely to react to financing headlines, Nasdaq compliance developments, and any BD/partnership around vurolenatide .

Supporting citations:

  • Q1 2023 8‑K/press release (business update, financing, forbearance, EPS/net loss): .
  • Q1 2023 10‑Q (financials, going concern, debt, cash flows, R&D breakdown, subsequent events): .
  • Prior quarter press releases (Q4 2022, Q3 2022) for trend and Phase 3 design/runway: .