October 3, 2022

Castlow

Be INvestment Confident

Motus GI Reports First Quarter 2022 Financial Results and Provides Business Update

Motus GI Holdings, Inc.

  • Pure-Vu EVS approved for use at 11 hospitals since product launch commenced in March 2022; with strong procedural volumes and significant positive feedback

  • Expansion of US commercial footprint ahead of schedule, with additional investments planned throughout 2022

  • Designing a large, multi-center trial as part of the strategy to secure reimbursement for the Pure-Vu EVS System for certain outpatient colonoscopies

FORT LAUDERDALE, Fla., May 12, 2022 (GLOBE NEWSWIRE) — Motus GI Holdings, Inc., (NASDAQ: MOTS) (“Motus GI” or the “Company”), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, today reported its financial results for the first quarter ended March 31, 2022, and provided a corporate update.

“As we guided at the end of March, our first quarter revenues were impacted by both the surge of Omicron in the US and associated staffing shortages at hospitals, as well as the sunsetting of Pure-Vu Gen2 and initiating our first commercial shipments of Pure-Vu EVS to US hospitals,” commented Tim Moran, Chief Executive Officer.

“During the first quarter, in addition to receiving FDA clearance for the Pure-Vu EVS, we accelerated the expansion of our sales organization as we look to capitalize on what we believe is the right technology to drive broader market adoption. Moreover, we continue to receive positive feedback from both physicians and staff regarding the advancements offered by the all-new Pure-Vu EVS. While it’s early into the commercial launch, we are excited to see physicians performing more procedures than before and, based on the simplicity of the new device, we believe accounts are becoming independent more rapidly. These are important initial indicators that we expect will lead to sustainable, quarterly revenue growth in the US market.”

“It was just six weeks ago that I forecasted we’d have Pure-Vu EVS placed in approximately 12 sites in the near-term. I’m pleased to report that midway through the second quarter, we’re well on track to far exceed that expectation, having Pure-Vu EVS approved for use at 11 hospital accounts since March,” commented Mr. Moran.

First Quarter and Recent Business Highlights

  • Received 510(k) clearance from the U.S. FDA for the Pure-Vu EVS System in mid-February 2022.

  • March represented a key transitional period for the Company as it completed the sunsetting activities of Pure-Vu Gen2 and began shipments of the all-new Pure-Vu EVS to U.S. customers.

  • Company on track with initial guidance of placing Pure-Vu EVS at first 12 sites

  • Clinical Data Generation

    • Completed enrollment in the European Union (EU) study of the Pure-Vu System, which is evaluating the clinical outcomes in patients with a history of poor bowel preparation using both a low volume preparation with limited diet restrictions and the Pure-Vu System. The Company expects to announce topline data from the study at a leading scientific conference in May 2022.

Financial Results for the First Quarter Ended March 31, 2022

The Company reported revenue of $20,000 for the first quarter 2022, compared to $51,000 for the same period last year. The impact of both the Omicron variant early in the first quarter and the controlled phase-out of the Gen 2 System ahead of the EVS launch later in the quarter significantly affected our first quarter results. The Company believes that these specific factors will be less impactful in the second quarter of 2022 and beyond.

For the three months ended March 31, 2022, the Company reported a net loss attributable to common sharholders of $4.8 million, or $0.09 per basic and diluted share, compared to a net loss attributable to common shareholders of $10.8 million, or $0.25 per basic and diluted share, for the same period last year, which included the impact of a non-cash “deemed dividend from warrant issuance” of $6.1 million.

During the first quarter 2022, net cash used in operating activities and for the purchase of fixed assets was $5.2 million as compared to $4.7 million for the same period of 2021. First quarter 2022 cash expenditures included certain one-time annual outflows associated with compliance and corporate matters, totaling approximately $1.8 million, which is not expected to recur in future quarters this year.

The Company reported $20.3 million in cash and cash equivalents as of March 31, 2022. This balance includes the fully funded $12.0 million credit facility with Kreos Capital. The Company’s current cash balance allows it to continue executing on its upcoming catalysts and is expected to meet overall anticipated cash needs into Q1 2023.

Motus GI Holdings, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets Highlights
(unaudited, in thousands)

As of

March 31, 2022

December 31, 2021

Cash

$

20,338

$

22,563

Working capital

19,024

20,629

Total assets

24,425

26,089

Total shareholders’ equity

8,607

9,657

Conference Call:

The Motus GI management team has scheduled a conference call for today, May 12th, at 4:30 p.m. ET to discuss these results. To access the conference call, investors are invited to dial (844) 825-9789 (U.S. and Canada) or (412) 317-5180 (International). The conference ID number is 10166381. A live audio webcast can be accessed by visiting the investor relations section of the Company’s website, www.motusgi.com or (click here). A replay of the webcast will be archived on the Motus GI website for 90 days following the event.

About Motus GI

Motus GI Holdings, Inc. is a medical technology company, with subsidiaries in the U.S. and Israel, providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions.

For more information, visit www.motusgi.com and connect with the Company on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This press release contains certain forward-looking statements. Forward-looking statements are based on the Company’s current expectations and assumptions. The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms, including without limitation, risks related to the continued impact of the COVID-19 pandemic, risks inherent in the development and commercialization of potential products, possible or assumed future results of operations, business strategies, potential grow opportunities, uncertainty in the timing and results of clinical trials or regulatory approvals, maintenance of intellectual property rights or other risks discussed in the Company’s quarterly and annual reports filed with the Securities and Exchange Commission, and its other filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:
Troy Williams
LifeSci Advisors
(518) 221-0106
[email protected]

Motus GI Holdings, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)

March 31,

December 31,

2022

2021

(unaudited)

Assets

Current assets:

Cash and cash equivalents

$

20,338

$

22,563

Accounts receivable

18

109

Inventory

700

496

Prepaid expenses and other current assets

1,347

793

Total current assets

22,403

23,961

Fixed assets, net

1,366

1,428

Right-of-use assets

643

687

Other non-current assets

13

13

Total assets

$

24,425

$

26,089

Liabilities and Shareholders’ Equity

Current liabilities:

Accounts payable and accrued expenses

$

1,992

$

2,584

Operating lease liabilities – current

296

307

Other current liabilities

8

10

Current portion of long-term debt, net of unamortized debt discount of $274 and $271, respectively

1,083

431

Total current liabilities

3,379

3,332

Contingent royalty obligation

1,731

1,760

Operating lease liabilities – non-current

346

385

Convertible note, net of unamortized debt discount of $153 and $166, respectively

3,847

3,834

Long-term debt, net of unamortized debt discount of $268 and $588, respectively

6,515

7,121

Total liabilities

15,818

16,432

Commitments and contingent liabilities (Note 9)

Shareholders’ equity

Common stock $0.0001 par value; 115,000,000 shares authorized; 55,059,891 and 48,320,986 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively

5

5

Additional paid-in capital

136,167

132,406

Accumulated deficit

(127,565

)

(122,754

)

Total shareholders’ equity

8,607

9,657

Total liabilities and shareholders’ equity

$

24,425

$

26,089

Motus GI Holdings, Inc. and Subsidiaries
Condensed Consolidated Statements of Comprehensive Loss
(unaudited, in thousands, except share and per share amounts)

Three Months Ended
March 31,

2022

2021

Revenue

$

20

$

51

Operating expenses:

Cost of Revenue – sales

15

28

Cost of Revenue – impairment of inventory

159

Research and development

1,275

1,345

Sales and marketing

983

676

General and administrative

2,114

2,444

Total costs and expenses

4,546

4,493

Operating loss

(4,526

)

(4,442

)

Gain (loss) on change in estimated fair value of contingent royalty obligation

29

(80

)

Finance expense, net

(332

)

(117

)

Foreign currency gain (loss)

18

(10

)

Net loss

$

(4,811

)

$

(4,649

)

Deemed dividends from warrant issuance

(6,145

)

Net loss attributable to common shareholders

$

(4,811

)

$

(10,794

)

Basic and diluted loss per common share:

Net loss attributable to common shareholders

$

(0.09

)

$

(0.25

)

Weighted average number of common shares outstanding, basic and diluted

51,794,258

42,230,001