Form 8-K - Current report

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):

January 8, 2024

_________________________________________

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, CA 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:


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

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

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

o			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 o

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. o

Item 2.02. Results of Operations and Financial Condition.

On January 8, 2024, ClearPoint Neuro, Inc. (the “Company”) issued a press release announcing its preliminary, unaudited financial results for the fourth fiscal quarter ended December 31, 2023. 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 January 8, 2024, 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 J anuary 8, 2024

Exhibit 99.2			Investor Presentation dated Janua ry 8, 2024

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: January 8, 2024	CLEARPOINT NEURO, INC.

	By:	/s/ Danilo D’Alessandro
		Danilo D’Alessandro
		Chief Financial Officer

Exhibit 99.1

ClearPoint Neuro Reports Fourth Quarter and Full Year 2023 Preliminary Revenue Results and Guidance for Full Year 2024 Revenue

SOLANA BEACH, CA, January 8, 2024 – 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, 2023. These preliminary unaudited financial results are management’s estimates and are subject to revision in the course of completing annual audit processes. Audited results for 2023 will be publicly reported by the Company later in the first quarter of 2024, prior to a Form 10-K filing for the year with full financial statements.

Fourth Quarter 2023 Preliminary Unaudited Financial Highlights

•Preliminary unaudited revenue of approximately $6.8 million, a 32% year-over-year increase;

•Increased biologics and drug delivery revenue to approximately $4.1 million, a 76% year-over-year increase; and

•Cash burn of approximately $1.2 million in the fourth quarter. The Company had approximately $23.1 million in cash and cash equivalents at December 31, 2023.

Full Year 2023 Preliminary Unaudited Financial Highlights

•Achieved preliminary unaudited record revenue of approximately $24 million, a 17% year-over-year increase, versus most recent guidance of $23 - $25 million; and

•Increased biologics and drug delivery revenue to approximately $13.6 million, a 49% year-over-year increase.

Business Outlook and Planned Value Creating Milestones

•The Company estimates revenue in 2024 to be between $28 million and $32 million, representing growth between 17% and 33%;

•Achieve FDA clearance and launch SmartFrame OR for navigation and first revenue in the operating room;

•Launch full market release of the ClearPoint PRISM® Neuro Laser Therapy System;

•Launch and deploy ClearPoint 2.2 Software with embedded ClearPoint Maestro® and 1.2 Array Software with parallel trajectory tumor planning application to the installed base;

•Win first purchase orders for GLP ready pre-clinical services;

•Prototype demonstration of next generation software application for AI predictive modeling to pharma partners;

•Continue global expansion to achieve 100 ClearPoint sites by 2025; and

•Demonstrate operating leverage with expenses increasing less than revenue growth.

“We are thrilled with our fourth quarter performance delivering record revenue of $6.8 million, reflecting 32% growth, while meaningfully reducing our cash burn and gaining commitments for multiple new ClearPoint installations,” commented Joe Burnett, President and CEO at ClearPoint Neuro.

“In 2024, we look forward to several new product introductions reflecting success with the strategic investments we have made to expand our leadership position, including the SmartFrame OR for our entrance into the operating room; the full market release of the PRISM laser therapy system; the integration of ClearPoint Maestro into our navigation software; and the expansion of our pre-clinical biologics and drug delivery services including GLP readiness. These represent four new potential revenue streams that we plan to add to our base business throughout the year.”

Management will be available for meetings in San Francisco during the J.P. Morgan Healthcare Conference from January 8-11, 2024.

About ClearPoint Neuro

ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.

Forward-Looking Statements

This press release contains forward-looking statements within the context of the federal securities laws, including the Company’s expectation for revenues, operating expenses, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, the future market of its products and services, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which 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: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval 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, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, 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, 2023, which the Company intends to file with the Securities and Exchange Commission on

or before March 31, 2024. The Company does not assume any obligation to update these forward-looking statements.

Contact:

Danilo D’Alessandro, Chief Financial Officer

(888) 287-9109

ir@clearpointneuro.com

© 2 0 2 4 C L E A R P O I N T N E U R O 2 This presentation and discussion contain forward-looking statements within the context of the federal securities laws, including the Company’s expectation for revenues, gross margin, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, the future market of its products and services, and other performance and results. These forward looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which 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: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval 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, 2022, and the Company’s Quarterly Reports on Form 10-Q for the three months ended September 30, 2023, both of which the Company filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2024. We do not assume any obligation to update these forward-looking statements.

• • • • • • • • • • • *Including owned and licensed patents 4

ClearPoint Neuro Navigation Software v.2.1 ClearPoint Array Software v.1.2 ClearPoint Maestro® Brain Model Inflexion® Head Fixation Frame MRI Coils MRI Monitor Multi-Positional Head Fixation Frame Accessory Kit (4Fr, 5Fr, and 7Fr Available) SmartFrame Array® Kit Components Capital Hardware and Software Disposables 6© 2 0 2 4 C L E A R P O I N T N E U R O

7 (A) (B) (D,E) © 2 0 2 4 C L E A R P O I N T N E U R O (A) Estimated and subject to revision (B) Unaudited as of, and for the quarter ended December 31, 2023 (C) Including owned and licensed patents (D) For the Trailing Twelve Months (TTM) (E) Unaudited as of, and for the quarter ended September 30, 2023 (C) $3.6 Revenue Guidance $4.6 $5.7 $7.4 $7.4 $11.2 $12.8 $16.3 $20.6 $24.0 $28.0 - $32.0 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Preliminary unaudited financial results for the year 2023 are management’s estimates and are subject to revision in the course of completing annual audit processes

© 2 0 2 1 C L E A R P O I N T N E U R O 8 • 1,500 sq. ft Class 8 Clean Room with Expansion Capability • 1,300 sq. ft Dedicated R&D Lab Space • ISO 13485/MDSAP/EU MDR Certified Quality System • Successful Audit Outcomes from Global Regulatory Bodies and Pharma • Training Facility with over 100 Surgeons and Pharma Scientist Visitors 8© 2 0 2 4 C L E A R P O I N T N E U R O

© 2 0 2 4 C L E A R P O I N T N E U R O 10 VISUALASE ClearPoint Navigation is Compatible with all Major Diagnostic and Intraoperative MRI Scanners …with 50+ industry and academic partners *In approved clinical trials and preclinical studies.

Parkinson’s Disease 1,000,0001 60,0001 • $270 M - $1.35 B Drug Resistant Epilepsy 1,000,0002 11,0003 • $49.5 M - $198 M Refractory Essential Tremor 3,500,0004 60,0005 $180 M - $1.08 B Brain Tumors (n=3)6 35,0007,8 13,3007,8 $33.3 M - $300 M Severe Obsessive-Compulsive Disorder 500,0009,10 10,0009,10 $45 M - $75 M Dystonia 250,00011 8,00012 $36 M - $60 M Rare Genetic/Lysosomal (n=7)13 36,50014-18 3,00014,19,20 $13.5 M - $67.5 M Paralysis / Spinal Cord (n=15)21,22 331,00022-24 17,90023 $80.6 M - $403 M Huntington’s Disease 30,00025 4,00025 $18 M - $90 M Alzheimer’s Disease 6,000,00026 500,00026 $1.5 B - $11.3 B Severe Major Depressive Disorder 1,000,00010 20,00010,27 $90 M - $150 M Stroke Rehabilitation 2,000,00028 610,00028 $1.83 B - $5.49 B Frontotemporal Dementia 60,00029 12,00029 $54 M – $270 M $4.2 B - $20.8 B 11 *Citations & footnotes on next slide Indication Patient Population Annual Incidence Pillar 2: DBS & BCI Pillar 3: Laser Therapy Pillar 1: Drug/Cell Delivery Incremental Revenue from Annual Incidence Pillar 4: Global Expansion Commercial U.S or EU ClearPoint procedures today ~2 X U.S. Revenue Active clinical trial Pre-clinical study/testing

© 2 0 2 4 C L E A R P O I N T N E U R O 12 1. “Parkinson’s Disease Statistics,” Parkinson’s News Today, https://parkinsonsnewstoday.com/parkinsons-disease-statistics/#:~:text=An%20estimated%20seven%20to%2010,who%20are%2080%20and%20older 2. Neurona Therapeutics. (2021 November 4). Neurona Therapeutics Receives IND Clearance to Initiate Phase 1/2 Clinical Trial of Neural Cell Therapy NRTX-1001 in Chronic Focal Epilepsy Patients [Press release] https://www.neuronatherapeutics.com/wp-content/uploads/2021/11/2021_11_01_-INDClearance_FINALVersion.pdf 3. Asadi-Pooya AA, Stewart GR, Abrams DJ, Sharan A. Prevalence and Incidence of Drug-Resistant Mesial Temporal Lobe Epilepsy in the United States. World Neurosurg. 2017;99:662-666. 4. Zesiewicz TA, Chari A, Jahan I, Miller AM, Sullivan KL. Overview of essential tremor. Neuropsychiatr Dis Treat. 2010;6:401-408. Published 2010 Sep 7. 5. Diaz NL, Louis ED. Survey of medication usage patterns among essential tremor patients: movement disorder specialists vs. general neurologists. Parkinsonism Relat Disord. 2010;16(9):604-607. 6. Includes: Glioblastoma, Diffuse Intrinsic Pontine Glioma and deep small eloquent brain tumors. 7. “Glioblastoma Multiforme,” American Association of Neurological Surgeons, https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Glioblastoma-Multiforme 8. “About DIPG/DMG,” DIPG/DMG Registry, https://dipgregistry.org/patients-families/about-dipg-dmg/ 9. Medtronic Clinical Summary – Reclaim DBS for Chronic Extreme OCD M947128A001. 10. Mantovani A, Lisanby SH. Brain stimulation in the treatment of anxiety disorders. In: Simpson HB, Neria Y, Lewis-Fernández R, Schneier F, eds. Anxiety Disorders: Theory, Research and Clinical Perspectives. Cambridge: Cambridge University Press; 2010:323-335. 11. https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Dystonia 12. Medtronic DBS™ Therapy for Dystonia - Clinical Summary 2015. 13. Includes: AADC deficiency, Friedreich’s ataxia, Angelman syndrome, multiple system atrophy, metachromatic leukodystrophy, and spinocerebellar ataxia type 3. 14. "Multiple System Atrophy," Medscape, https://emedicine.medscape.com/article/1154583-overview#a6 15. PTC Therapeutics November 30, 2021 Corporate Presentation, https://ir.ptcbio.com/static-files/0fd5d54f-55b8-416b-8006-4eb4c0d82f45 16. “Spinocerebellar ataxia type 3,” Orphanet, https://www.orpha.net/consor/cgi-bin/OC_Exp.php?lng=EN&Expert=98757 17. Lysogene Corporate Presentation at 38th Annual J.P. Morgan Healthcare Conference on Jan 13, 2020, http://www.lysogene.com/wp-content/uploads/2020/01/jpm-2020-corporate-presentation_final.pdf 18. “Metachromatic Leukodystrophy,” National Organization of Rare Disorders, https://rarediseases.org/rare-diseases/metachromatic-leukodystrophy/ 19. “Aromatic L’Amino Acid Decarboxylase Deficiency,” National Organization for Rare Disorders, https://rarediseases.org/rare-diseases/aromatic-l-amino-acid-decarboxylase-deficiency/ 20. Puckett Y, Mallorga-Hernández A, Montaño AM. Epidemiology of mucopolysaccharidoses (MPS) in United States: challenges and opportunities. Orphanet J Rare Dis. 2021;16(1):241. Published 2021 May 29. 21. Includes: stroke, spinal cord injury, multiple sclerosis, cerebral palsy, other (traumatic brain injury, complications from surgery, amyotrophic lateral sclerosis, neurofibromatosis, Chiari malformation, syringomyelia, postpolio syndrome, spinal muscular atrophy, Friedreich’s ataxia, transverse myelitis, and spina bifida). 22. Armour BS, Courtney-Long EA, Fox MH, Fredine H, Cahill A. Prevalence and Causes of Paralysis-United States, 2013. Am J Public Health. 2016;106(10):1855-1857. 23. Wyndaele M, Wyndaele JJ. Incidence, prevalence and epidemiology of spinal cord injury: what learns a worldwide literature survey?. Spinal Cord. 2006;44(9):523-529. 24. National Spinal Cord Injury Statistical Center (NSCISC): 2020 Annual Report and 2021 Facts and Figures. https://www.nscisc.uab.edu/ 25. “Huntington’s Disease,” Mov Disord. 2019 Jun; 34(6): 858–865. 26. “Alzheimer’s Disease: Facts & Figures,” Brightfocus Foundation, https://www.brightfocus.org/alzheimers/article/alzheimers-disease-facts-figures 27. Goodman WK, Alterman RL. Deep brain stimulation for intractable psychiatric disorders. Annu Rev Med. 2012;63:511-524. 28. “Stroke Facts,” Center for Disease Control and Prevention, https://www.cdc.gov/stroke/facts.htm 29. Onyike CU, Diehl-Schmid J. The epidemiology of frontotemporal dementia. Int Rev Psychiatry. 2013;25(2):130-137.

NEW THERAPY DEVICES NEURO NAVIGATION FOR DBS BIOLOGICS & DRUG DELIVERY 20252024 4 Pillar Growth Strategy by 2025 Development Pipeline Over the Next Two Years Full Market Release for PRISM Neuro Laser Integrate Tumor Segmentation Software Activate Maestro Ablation Coverage & A.I. Predictive Modeling ACHIEVE GLOBAL SCALE Expand Global Footprint to 100+ Centers Perform Procedures w/ Remote Clinical Support Achieve 60%+ Margins & Operational Cashflow Breakeven © 2 0 2 4 C L E A R P O I N T N E U R O 13 Expand Neuro Pre-Clinical CRO Services and Capacity Including GLP Capability Expand Partnerships to Include Co-Development, Pass Through Sales, Drug Clinical Milestones & Royalty Based Agreements Execute on Development Pipeline for Drug Infusion Monitoring/Modelling, Intracranial Cell Therapy and Spinal Routes of Administration Expand into the Operating Room w/ ClearPoint OR Show Compatibility with Existing Third-Party Navigation w/ SmartFrame OR Launch Maestro CT, Non-Rigid Fusion, Area-of-Activation and DTI Harmony Software

© 2 0 2 4 C L E A R P O I N T N E U R O 14 Radially Branching Cell therapy Devices ClearPoint Orchestra™ Head Fixation Frame Spinal Infusion Anchoring Devices PRISM 3.0 T & 1.5 T Compatible Systems (1.5 T Compatibility not yet FDA Cleared) Array 1.2 Parallel Trajectory Tumor Feature *Biologics & Drug Delivery Programs are for use in pre-clinical and clinical trials only ClearPoint 2.2 Software w/ Embedded ClearPoint Maestro® ClearPointer™ and SmartFrame O.R. FDA 510(k) Pending

© 2 0 2 4 C L E A R P O I N T N E U R O 15 • FDA Cleared, Shape Constrained, triangular mesh model enables point-based correspondence across multiple subjects • Auto-Segmentation for Device Targeting • Direct Navigation in Clinical Trials for Drug Delivery • Longitudinal Comparison for Pharma Trial follow-up • Platform Engine for future navigation tools for Drug Delivery, DBS, BCI, Biopsy and Laser Therapy • Expandable to CT Guidance in the Operating Room *The ClearPoint Maestro® Brain Model is only available in the United States.

© 2 0 2 4 C L E A R P O I N T N E U R O 16 Unique platform technology with 10+ years of commercial experience enabling Precision MRI-Guided Therapies to restore quality of life for some of the most debilitating disorders Large, growing number of customer and partner sites of 75+ leading Neurosurgery and research centers worldwide, on pace to be in 100+ by 2025 Expandable Platform through advanced A.I. and machine learning software applications and strategic partnerships Pipeline of new revenue streams through the expansion into the Operating Room, Launch of our own PRISM Laser Therapy, Maestro Brain Model Deployment and addition of pre-clinical services and capacity including GLP Total potential addressable market > $12B for our products, pipeline and partnerships A growing and passionate team of embedded scientists and specialists

Cover	Jan. 08, 2024
Cover [Abstract]
Document Type	8-K
Document Period End Date	Jan. 08, 2024
Entity Registrant Name	CLEARPOINT NEURO, INC
Entity Incorporation, State or Country Code	DE
Entity File Number	001-34822
Entity Tax Identification Number	58-2394628
Entity Address, Address Line One	120 S. Sierra Ave., 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
Entity Emerging Growth Company	false
Amendment Flag	false
Entity Central Index Key	0001285550