Executive Summary

Q3 2023 was operationally significant but financially weak: revenue fell to $0.086M from $0.278M YoY while net loss narrowed to $2.68M; FDA clearance for Pure‑Vu EVS Gastro and Gen 4 Colon was achieved, enabling market introduction by year‑end .
No Wall Street consensus (S&P Global) was available for MOTS; therefore, estimate comparisons are not possible.
Cash and equivalents decreased to $5.7M; management reiterated runway “through Q1 2024,” highlighting the need for strategic and financing alternatives to fund commercialization of the Pure‑Vu System .
Potential stock reaction catalysts: regulatory clearance, initial placements at top hospital systems, and progress on strategic alternatives; offset by deteriorating revenue and limited cash runway .

What Went Well and What Went Wrong

What Went Well

FDA clearance obtained for the Pure‑Vu EVS Gastro and Gen 4 Colon via special 510(k), positioning for broader U.S. market introductions by end of 2023 .
- “We believe gastroenterologists are eager to begin utilizing these new products, especially in the emergent setting of an upper GI bleed…” — CEO Mark Pomeranz .
International regulatory progress: AMAR approval in Israel; CE Mark in final stages under MDR; supply chain described as “strong” to support strategic initiatives .
Corporate steps: appointment of industry veteran Scott Durbin to Board; continued exploration of strategic and financing alternatives aimed at accelerating commercialization and maximizing stockholder value .

What Went Wrong

Revenue deterioration: $0.086M in Q3 2023 vs $0.278M in Q3 2022; sequentially down from $0.113M in Q2 2023, indicating weak commercial momentum ahead of next‑gen launches .
Cash draw and constrained runway: cash fell to $5.7M at 9/30/23 (from $8.5M at 6/30/23); management indicates runway only through Q1 2024; Kreos Capital facility has ~$9.2M due outstanding .
Balance sheet/royalty clean‑up signals pressure: royalty rights cancelled in exchange for 97,042 shares, removing ~$1.1M contingent royalty obligations; while helpful, it underscores capital structure constraints .

Financial Results

Metric	Q3 2022	Q1 2023	Q2 2023	Q3 2023
Revenue ($USD)	$278,000	$56,000	$113,000	$86,000
Net Loss ($USD)	$(4,964,000)	$(4,386,000)	$(2,997,000)	$(2,679,000)
Diluted EPS ($USD)	$(26.99)	$(0.92)	$(0.40)	$(4.28)
Total Costs and Expenses ($USD)	$4,983,000	$4,415,000	$2,795,000	$2,480,000
Cash and Equivalents ($USD)	N/A	$8,648,000	$8,521,000	$5,724,000

Notes: Q3 2023 EPS per share data is split‑adjusted following the November 2, 2023 reverse split . Revenues were primarily from disposable sleeve sales and limited workstation sales .

No segment/KPI breakdown disclosed beyond product sales mix.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	FY23–Q1’24	Sufficient to fund commercial, R&D, corporate operations through Q1 2024	Sufficient to fund commercial, R&D, corporate operations through Q1 2024	Maintained
Regulatory Milestone (Pure‑Vu EVS Gastro & Gen 4 Colon)	Q4’23 timing	On track to submit special 510(k) before end of year	FDA clearance received for EVS Gastro & Gen 4 Colon special 510(k)	Achieved/Positive
Market Introduction Timing (U.S.)	By end of 2023	Preparing for next‑gen launch; growing hospital approvals (e.g., Banner network)	Initiate market introductions into top U.S. hospital systems by end of 2023	More specific/timing affirmed

No quantitative revenue/margin/OpEx/tax guidance disclosed.

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2 2023)	Current Period (Q3 2023)	Trend
Regulatory/Approvals	Q1: Upper GI Pure‑Vu EVS Gastro development; aim for 510(k) submission in Q4 2023 . Q2: On track for special 510(k) submission; both Gastro & Colon to use same workstation .	FDA clearance obtained for EVS Gastro & Gen 4 Colon special 510(k) .	Improving (milestone achieved)
International Commercialization	Q2: AMAR approval to sell Pure‑Vu EVS in Israel; evaluating EU strategies .	AMAR approval reiterated; CE Mark in final stages under MDR .	Progressing
Cost Structure/Execution	Q1/Q2: Cost cuts expected to reduce OpEx cash burn >50%; restructuring charges incurred .	Continued focus on commercialization efficiency; supply chain described as strong .	Stabilizing
Strategic & Financing Alternatives	Q1/Q2: Exploring strategic/financing alternatives to accelerate commercialization .	Exploration process continues; board appointment; royalty rights cancellation cleans balance sheet .	Ongoing
Hospital System Adoption	Q2: Banner network approval; initial system installed .	Targeting top U.S. hospital systems for reference centers with new devices .	Building pipeline

No Q3 2023 earnings call transcript was located; themes above are derived from press releases/8‑K filings.

Management Commentary

“These activities have included achieving a number of regulatory and corporate milestones to better position the Company… evaluating strategic and financing alternatives aimed at accelerating market introduction of the Pure‑Vu System and maximizing stockholder value.” — CEO Mark Pomeranz .
“We are working diligently to place the new device in top hospital systems in order to build a base of reference centers to support our strategic initiatives.” — CEO Mark Pomeranz .
Company reiterates preparation for market introduction and underscores unmet need in upper GI bleeds (approx. 400,000 U.S. cases annually) .

Q&A Highlights

No public Q3 2023 earnings call transcript was found; Motus GI appears not to have published an earnings call transcript for Q3 2023. Source checks: company press release distribution via GlobeNewswire/Yahoo Finance .

Estimates Context

Wall Street consensus via S&P Global was unavailable for MOTS for Q3 2023 due to missing CIQ mapping in our data pipeline; as a result, estimate comparisons cannot be made. If available, consensus values would be sourced from S&P Global.

Key Takeaways for Investors

Regulatory de‑risking is significant: special 510(k) clearances for EVS Gastro and Gen 4 Colon enable imminent U.S. market introductions and potential early reference center placements .
Commercial metrics remain weak pre‑launch: sequential and YoY revenue declines suggest near‑term pressure until next‑gen devices ramp .
Balance sheet/runway is tight: cash fell to $5.7M with runway only through Q1 2024 and ~$9.2M due under the Kreos facility; strategic/financing actions are pivotal near‑term .
Strategic alternatives continue: cancellation of royalty rights cleans up ~$1.1M in contingent obligations and may aid future transactions .
Near‑term trading: potential positive headlines from initial hospital deployments and CE Mark progress; risk from limited runway and lack of estimate coverage.
Medium‑term thesis: adoption in emergent settings (upper GI bleed) and system standardization (one workstation for upper/lower GI) could expand addressable use cases; execution in hospital systems and monetization pace are key .
Monitor: reference center placements, CE Mark timing, additional financing or partnerships, and any emerging revenue traction from EVS Gastro/Gen 4 Colon.

Sources: Q3 2023 Form 8‑K/Exhibit 99.1 press release and financials ; Q2 2023 8‑K/Exhibit 99.1 ; Q1 2023 8‑K/Exhibit 99.1 ; Distribution references .

Motus GI Holdings, Inc. (MOTS)·Q3 2023 Earnings Summary