8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

February 15, 2022

CLEARPOINT NEURO, INC.

(Exact name of registrant as specified in its charter)

delaware	001-34822	58-2394628
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)

120 S. Sierra Ave., Suite 100
Solana Beach, California 92075

(Address of principal executive offices, zip code)

(888) 287-9109

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.01 par value per share	CLPT	Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 2.02. Results of Operations and Financial Condition.

On February 15, 2022, ClearPoint Neuro, Inc. (the “Company”) issued a press release announcing its preliminary, unaudited financial results for the fourth fiscal quarter and year ended December 31, 2021. A copy of the press release is furnished herewith as Exhibit 99.1.

The information in Item 2.02 of this Form 8-K, as well as Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 7.01. Regulation FD Disclosure.

On February 15, 2022, the Company posted an updated investor presentation to its website at http://ir.stockpr.com/clearpointneuro/investor-presentations. A copy of the investor presentation is being furnished herewith as Exhibit 99.2. The Company may use the investor presentation from time to time in conversations with analysts, investors and others.

The information in Item 7.01 of this Form 8-K, as well as Exhibit 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item  9.01 Financial Statements and Exhibits.

(d) Exhibits.

The following exhibit is furnished herewith:

Exhibit 99.1	Press Release dated February 15, 2022
Exhibit 99.2	Investor Presentation dated February 2022
Exhibit 104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: February 15, 2022	CLEARPOINT NEURO, INC.
	By:	/s/ Danilo D’Alessandro
		Danilo D’Alessandro
		Chief Financial Officer

EX-99.1

Exhibit 99.1

 

ClearPoint Neuro Reports Fourth Quarter and Full Year 2021 Preliminary Revenue Results and Guidance for Full Year 2022 Revenue

Company to Hold Earnings Call on March 1, 2022

SOLANA BEACH, CA, February 15, 2022 – ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced preliminary, unaudited financial results for its fourth quarter and full year ended December 31, 2021. The Company also announced that its earnings call will take place on Tuesday, March 1, 2022, after the market close.

Fourth Quarter 2021 Revenue Highlights

· Reported revenue of $4.3 million, a 15% year-over-year increase;

· Increased functional neurosurgery products and services to $2.1 million, a 37% year-over-year increase;

· Increased biologics and drug delivery revenue to $1.7 million, a 10% year-over-year increase;

· Clinical team supported 239 cases despite a regional impact of the Omicron variant on elective procedures, a 37% year-over-year increase.

Full Year 2021 Revenue Highlights

· Achieved record revenue of $16.3 million, a 27% year-over-year increase and within the initial 2021 forecast of $16.0 - $17.5 million despite the impact of both Delta and Omicron variants throughout the year on elective procedures and supply chain;

· Achieved record case volume of 929 cases, a 36% year-over-year increase and within initial 2021 forecast of 900 – 1,000 cases supported by our clinical specialist team;

· The Company had approximately $54.1 million in cash and cash equivalents at December 31, 2021.

Business Outlook

· The Company estimates revenue in 2022 to be between $20.0 and $22.0 million, representing growth between 23% and 35%;

· The single largest risk factor for 2022 revenue is expected to remain the impact of COVID, including the resumption of elective procedures post-Omicron and the risk of new emerging variants as seen in 2021.

“As we close the books on 2021, we reflect on a tremendous year for the Company as we have continued to execute and make progress across our four-pillar growth strategy,” commented Joe Burnett, President and CEO of ClearPoint Neuro. “Overall, we achieved record revenue and case volume across all of our segments including functional neurosurgery, biologics and drug delivery and capital and service. We also met our initial guidance for both revenue and case volume despite multiple disruptions to elective procedures caused by the Delta and Omicron variants.”

“We continue to manage the business appropriately during these uncertain times caused by the pandemic and will use our existing capital to balance growth with thoughtful spending. Our current cash position entering 2022 is $54.1 million and we do not at present feel the need for additional capital at any time in 2022. We have a unique product offering at a special time and will continue to invest and innovate in the neurosurgical space. If you add up all the different patient indications where we plan to participate using our platform supporting Biologics, Deep Brain Stimulation, Brain-Computer-Interfaces, and laser ablation, the total amounts to 35 different patient populations. In the United States alone, this represents approximately one million new patients diagnosed each year across these various indications who could one day benefit from treatments utilizing the ClearPoint platform.”

Investors and analysts are invited to listen to a live broadcast review of the Company's fourth quarter and full year 2021 financial results on Tuesday, March 1, 2022 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://themediaframe.com/mediaframe/webcast.html?webcastid=ZSukJDu1. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada.

For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until Thursday, March 31, 2022 by calling (877) 660-6853, or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's website at www.clearpointneuro.com, on the “Investor Relations” page.

About ClearPoint Neuro

ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, neuro-aspiration, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint^® Neuro Navigation System has FDA clearance, is CE-marked, and is installed in approximately 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with approximately 40 biologics/pharmaceutical companies and academic centers, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 5,000 cases have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners. For more information, please visit www.clearpointneuro.com.

Forward-Looking Statements

Statements herein concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of the COVID-19 pandemic and the measures adopted to contain its spread; future revenue from sales of the Company’s ClearPoint Neuro Navigation System products; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System products; and risks inherent in the research and development of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2021, both of which have been filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2022.

Contact:

Danilo D’Alessandro, Chief Financial Officer
(949) 900-6833

info@clearpointneuro.com

Caroline Corner, Investor Relations

ir@clearpointneuro.com

EX-99.2

Exhibit 99.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

XML

Cover	Feb. 15, 2022	Dec. 15, 2021
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 15, 2022
Entity File Number	001-34822
Entity Registrant Name	CLEARPOINT NEURO, INC.
Entity Central Index Key	0001285550
Entity Tax Identification Number	58-2394628
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	120 S. Sierra Ave.
Entity Address, Address Line Two	Suite 100	,
Entity Address, City or Town	Solana Beach
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92075
City Area Code	(888)
Local Phone Number	287-9109
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.01 par value per share
Trading Symbol	CLPT
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false