0001285550FALSE00012855502024-08-072024-08-07
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):
August 7, 2024
_________________________________________
CLEARPOINT NEURO, INC.
(Exact name of registrant as specified in its charter)
_________________________________________
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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:
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o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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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 August 7, 2024, ClearPoint Neuro, Inc. (the “Company”) issued a press release announcing its financial performance for the second fiscal quarter ended June 30, 2024. 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 August 7, 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:
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Exhibit 99.1 | |
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Exhibit 99.2 | |
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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.
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Date: August 7, 2024 | CLEARPOINT NEURO, INC. |
| | |
| By: | /s/ Danilo D’Alessandro |
| | Danilo D’Alessandro |
| | Chief Financial Officer |
Exhibit 99.1
ClearPoint Neuro Reports Second Quarter 2024 Results
Second Quarter Revenue Growth +32%; Record Revenue Achieved
SOLANA BEACH, CA, August 7, 2024 – ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced financial results for its second quarter ended June 30, 2024.
Second Quarter Highlights
•Reported quarterly revenue of $7.9 million, a 32% year-over-year increase;
•Product revenue across all segments more than doubled, and grew 112% to $4.9 million;
•Increased Biologics and Drug Delivery revenue to $4.3 million, a 28% year-over-year increase;
•Full market release of SmartFrame OR™ platform and ClearPoint Prism® Laser Therapy System contributing to record navigation and device revenue of $2.6 million and 34% growth versus the prior quarter;
•Activated six new global centers in the second quarter for a total of fourteen new centers so far this year;
•Partners advancing through preclinical and clinical review with seven pharmaceutical partners receiving expedited FDA review designation;
•Approval of SmartFlow® Cannula for commercial use in Taiwan by the Taiwan Food and Drug Administration;
•Operational cash burn reduced to $2.7 million, a 47% year-over-year decrease;
•Cash and cash equivalents totaled $32.8 million as of June 30, 2024.
“This has been the strongest quarter in our history both from a financial standpoint as well as continued execution of our four-pillar growth strategy,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “In the second quarter of 2024, we were excited to achieve double-digit growth from all four pillars including Biologics and Drug Delivery, Neurosurgery Navigation, Therapy and Access Products, and achieving global scale through capital placements and customer activations. This has led to record quarterly revenue of $7.9 million, record product revenue of $4.9 million, gross margins rising to 63%, and an operating cash burn
reduction of 47% year over year. We expect to be well poised to continue this growth across all of our segments as we:
•Expand our biologics and drug delivery services and customers,
•Add long-term strategic agreements with pharmaceutical partners,
•Assist our biotech partners as they continue first-in-human study initiations,
•Continue our expansion into the operating room with SmartFrame OR,
•Expand our installed base of the PRISM Laser Therapy System under full market release, and
•Activate new capital customers by working through our sizable funnel of prospective customers.
As a result of our strong first half of 2024, we are raising our revenue guidance to between $30.0 and $33.0 million for the year 2024.”
Business Outlook
The Company is raising its full year 2024 revenue outlook to between $30.0 and $33.0 million.
Financial Results – Quarter Ended June 30, 2024
Total revenue was $7.9 million for the three months ended June 30, 2024, and $6.0 million for the three months ended June 30, 2023, which represents an increase of $1.9 million, or 32%.
Biologics and Drug Delivery revenue, which includes sales of services and disposable products related to customer-sponsored preclinical and clinical trials utilizing our products, increased 28% to $4.3 million for the three months ended June 30, 2024, from $3.4 million for the same period in 2023. This increase is attributable to a $1.3 million increase in product revenue as a result of increased demand for disposables as multiple partners progress in their trials, partially offset by a decrease of $0.4 million in service and other revenue, during the three months ended June 30, 2024, compared to the same period in 2023.
Neurosurgery Navigation and Therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 17% to $2.6 million for the three months ended June 30, 2024, from $2.2 million for the same period in 2023. The increase is driven by higher product revenue of $0.8 million as a result of increased case volume, new capital placements, and new product offerings (SmartFrame OR and Prism) during the three months ended June 30, 2024, compared to the same period in 2023. This is partially offset by a decrease of $0.4 million in service and other revenue primarily as a result of pausing a co-development program with one of our Brain Computer Interface partners, during the three months ended June 30, 2024, compared to the same period in 2023.
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, increased 148% to $0.9 million for the three months ended June 30, 2024, from $0.4 million for the same period in 2023 due to an increase in the placements of ClearPoint navigation capital and software and Prism laser units.
Gross margin for the three months ended June 30, 2024, was 63% compared to a gross margin of 53% for the three months ended June 30, 2023. The increase in gross margin was primarily due to lower costs for the three months ended June 30, 2024 due to the transition to the new manufacturing facility which was occurring in 2023, and higher volumes for the three months ended June 30, 2024.
Operating expenses for the second quarter of 2024 were $9.7 million, compared to $10.3 million for the second quarter of 2023. The decrease was mainly driven by lower product development costs and bad debt expense, partially offset by higher sales and marketing personnel expense.
At June 30, 2024, the Company had cash and cash equivalents totaling $32.8 million as compared to $23.1 million at December 31, 2023, with the increase resulting from the net proceeds from the public offering of
common stock of $16.2 million in the first quarter, partially offset by the use of cash in operating activities of $6.5 million in the six month period ending June 30, 2024.
Teleconference Information
Investors and analysts are invited to listen to a live broadcast review of the Company's 2024 second quarter on Wednesday, August 7, 2024 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=u0rzWezB. Investors and analysts who would like to participate in the conference call via telephone may do so at (888) 428-7458, or at (862) 298-0702 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 September 7, 2024, 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 Investor website at https://ir.clearpointneuro.com/.
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 preclinical 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 preclinical 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
Statements in this press release and in the teleconference referenced above 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, the size of total addressable markets or the market opportunity for the Company’s products and services, the Company’s expectation for revenues, operating expenses, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, 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. 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, 2023, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, both of which have been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months
ended June 30, 2024, which the Company intends to file with the Securities and Exchange Commission on or before August 14, 2024. The Company does not assume any obligation to update these forward-looking statements.
Contact:
Media Contact:
Jacqueline Keller, Vice President of Marketing
(888) 287-9109 ext. 4
info@clearpointneuro.com
Investor Relations:
Danilo D’Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.com
CLEARPOINT NEURO, INC.
Consolidated Statements of Operations
(Unaudited)
(in thousands, except for share and per share data)
| | | | | | | | | | | |
| For The Three Months Ended June 30, |
| 2024 | | 2023 |
Revenue: | | | |
Product revenue | $ | 4,944 | | | $ | 2,337 | |
Service and other revenue | 2,914 | | | 3,613 | |
Total revenue | 7,858 | | | 5,950 | |
Cost of revenue | 2,870 | | | 2,824 | |
Gross profit | 4,988 | | | 3,126 | |
Research and development costs | 3,120 | | | 3,605 | |
Sales and marketing expenses | 3,834 | | | 3,474 | |
General and administrative expenses | 2,773 | | | 3,178 | |
Operating loss | (4,739) | | | (7,131) | |
Other expense: | | | |
Other income (expense), net | 5 | | | (2) | |
Interest income, net | 326 | | | 81 | |
Net loss | $ | (4,408) | | | $ | (7,052) | |
Net loss per share attributable to common stockholders: | | | |
Basic and diluted | $ | (0.16) | | | $ | (0.29) | |
Weighted average shares used in computing net loss per share: | | | |
Basic and diluted | 27,468,378 | | | 24,583,712 | |
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| For The Six Months Ended June 30, |
| 2024 | | 2023 |
Revenue: | | | |
Product revenue | $ | 8,579 | | | $ | 4,967 | |
Service and other revenue | 6,918 | | | 6,416 | |
Total revenue | 15,497 | | | 11,383 | |
Cost of revenue | 5,984 | | | 5,055 | |
Gross profit | 9,513 | | | 6,328 | |
Research and development costs | 5,745 | | | 6,628 | |
Sales and marketing expenses | 7,124 | | | 6,407 | |
General and administrative expenses | 5,614 | | | 6,136 | |
Operating loss | (8,970) | | | (12,843) | |
Other expense: | | | |
Other expense, net | (21) | | | (13) | |
Interest income, net | 437 | | | 195 | |
Net loss | $ | (8,554) | | | $ | (12,661) | |
Net loss per share attributable to common stockholders: | | | |
Basic and diluted | $ | (0.32) | | | $ | (0.52) | |
Weighted average shares used in computing net loss per share: | | | |
Basic and diluted | 26,460,237 | | | 24,583,439 | |
CLEARPOINT NEURO, INC.
Consolidated Balance Sheets
(in thousands, except for share and per share data)
| | | | | | | | | | | |
| June 30, 2024 | | December 31, 2023 |
| (Unaudited) | |
ASSETS | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 32,845 | | | $ | 23,140 | |
Accounts receivable, net | 3,475 | | | 3,211 | |
Inventory, net | 8,031 | | | 7,911 | |
Prepaid expenses and other current assets | 2,205 | | | 1,910 | |
Total current assets | 46,556 | | | 36,172 | |
Property and equipment, net | 1,545 | | | 1,389 | |
Operating lease, right-of-use assets | 3,330 | | | 3,564 | |
Software license inventory | 236 | | | 386 | |
Licensing rights | 758 | | | 1,041 | |
Other assets | 149 | | | 109 | |
Total assets | $ | 52,574 | | | $ | 42,661 | |
| | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | |
Current liabilities: | | | |
Accounts payable | $ | 822 | | | $ | 393 | |
Accrued compensation | 2,996 | | | 2,947 | |
Other accrued liabilities | 1,302 | | | 1,053 | |
Operating lease liabilities, current portion | 516 | | | 424 | |
Deferred product and service revenue, current portion | 1,079 | | | 2,613 | |
2020 senior secured convertible note payable, net | 9,979 | | | — | |
Total current liabilities | 16,694 | | | 7,430 | |
Operating lease liabilities, net of current portion | 3,302 | | | 3,568 | |
Deferred product and service revenue, net of current portion | 446 | | | 541 | |
2020 senior secured convertible note payable, net | — | | | 9,949 | |
Total liabilities | 20,442 | | | 21,488 | |
Commitments and contingencies | | | |
Stockholders’ equity: | | | |
Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at June 30, 2024 and December 31, 2023 | — | | | — | |
Common stock, $0.01 par value; 90,000,000 shares authorized at June 30, 2024 and December 31, 2023; 27,588,812 shares issued and outstanding at June 30, 2024; and 24,652,729 issued and outstanding at December 31, 2023 | 276 | | | 247 | |
Additional paid-in capital | 212,866 | | | 193,382 | |
Accumulated deficit | (181,010) | | | (172,456) | |
Total stockholders’ equity | 32,132 | | | 21,173 | |
Total liabilities and stockholders’ equity | $ | 52,574 | | | $ | 42,661 | |
CLEARPOINT NEURO, INC.
Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
| | | | | | | | | | | |
| For The Six Months Ended June 30, |
| 2024 | | 2023 |
Cash flows from operating activities: | | | |
Net loss | $ | (8,554) | | | $ | (12,661) | |
Adjustments to reconcile net loss to net cash flows from operating activities: | | | |
Allowance for credit losses (recoveries) | (507) | | | 454 | |
Depreciation and amortization | 476 | | | 285 | |
Share-based compensation | 3,300 | | | 2,952 | |
Amortization of debt issuance costs and original issue discounts | 29 | | | 28 | |
Amortization of lease right-of-use, net of accretion in lease liabilities | 461 | | | 325 | |
Accretion of discounts on short-term investments | — | | | (126) | |
Increase (decrease) in cash resulting from changes in: | | | |
Accounts receivable | 244 | | | (588) | |
Inventory, net | (320) | | | 94 | |
Prepaid expenses and other current assets | (294) | | | (438) | |
Other assets | (39) | | | (25) | |
Accounts payable and accrued expenses | 726 | | | (282) | |
| | | |
Lease liabilities | (401) | | | (293) | |
Deferred revenue | (1,629) | | | (480) | |
Net cash flows from operating activities | (6,508) | | | (10,755) | |
Cash flows from investing activities: | | | |
Purchases of property and equipment | — | | | (461) | |
Acquisition of licensing rights | — | | | (167) | |
Proceeds from maturities of short-term investments | — | | | 10,000 | |
Net cash flows from investing activities | — | | | 9,372 | |
Cash flows from financing activities: | | | |
Proceeds from public offering of common stock, net of offering costs | 16,183 | | | — | |
Proceeds from stock option exercises | 21 | | | — | |
Payments for taxes related to net share settlement of equity awards | (279) | | | (82) | |
Proceeds from issuance of common stock under employee stock purchase plan | 288 | | | 314 | |
Net cash flows from financing activities | 16,213 | | | 232 | |
Net change in cash and cash equivalents | 9,705 | | | (1,151) | |
Cash and cash equivalents, beginning of period | 23,140 | | | 27,615 | |
Cash and cash equivalents, end of period | $ | 32,845 | | | $ | 26,464 | |
| | | |
SUPPLEMENTAL CASH FLOW INFORMATION | | | |
Cash paid for: | | | |
Income taxes | $ | — | | | $ | — | |
Interest | $ | 370 | | | $ | 369 | |
© 2 0 24 C LE A R P OI N T NE UR O 1
© 2 0 24 C LE A R P OI N T NE UR 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, 2023, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, both of which have been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2024, which the Company intends to file with the Securities and Exchange Commission on or before August 14, 2024. The Company does not assume any obligation to update these forward-looking statements.
© 2 0 24 C LE A R P OI N T NE UR O 3
• • • • • • • • • • • *Including owned and licensed patents 4
5© 2 0 24 C LE A R P OI N T NE UR O
ClearPoint Neuro Navigation Software v.2.2.1 With Integrated ClearPoint Maestro® Brain Model ClearPoint Array® Software v.1.2 ClearPoint Maestro® Brain Model Inflexion® Head Fixation Frame ClearPoint Prism® Neuro Laser Therapy System 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 24 C LE A R P OI N T NE UR O SmartFlow® Cannula SmartFrame® XG Kit Components ClearPoint Prism® Neuro Laser Fibers SmartFrame OR ClearPointer
7 (A) (B) (B,D) © 2 0 24 C LE A R P OI N T NE UR O (C) Revenue Guidance $7.4 $11.2 $12.8 $16.3 $20.6 $24.0 $30.0 - $33.0 2018 2019 2020 2021 2022 2023 2024 (A) Estimated and subject to revision (B) Unaudited as of, and for the quarter ended, June 30,2024 (C) Including owned and licensed patents (D) For the Trailing Twelve Months (TTM)
© 2 0 21 C LE A R P OI N T NE UR 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 24 C LE A R P OI N T NE UR O
© 2 0 24 C LE A R P OI N T NE UR O 9
© 2 0 24 C LE A R P OI N T NE UR 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 *Prevalence and Incidence for United States only 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 24 C LE A R P OI N T NE UR 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%20o lder 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. gen eral 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, an d 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, amy otrophic 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 24 C LE A R P OI N T NE UR 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 24 C LE A R P OI N T NE UR 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 OR
© 2 0 24 C LE A R P OI N T NE UR 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 24 C LE A R P OI N T NE UR O 16 Unique platform technology with 10+ years of commercial experience enabling Precision MRI-Guided and OR- based Therapies to restore quality of life for some of the most debilitating disorders Large, growing number of customer and partner sites of 85+ 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
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