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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):
December 29, 2023
GREENBROOK TMS INC.
(Exact name of registrant as specified in its
charter)
Ontario |
|
001-40199 |
|
98-1512724 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission
File No.) |
|
(IRS Employee
Identification No.) |
890 Yonge Street, 7th Floor
Toronto, Ontario Canada
M4W 3P4
(Address of Principal Executive Offices)
(866) 928-6076
(Registrant’s telephone number, including
area code)
(Former name or former address, if changed since
last report)
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 Shares, without par value |
|
GBNH |
|
The Nasdaq Stock Market LLC |
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 x
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 1.01 | Entry into a Material Definitive Agreement. |
On
December 29, 2023, Greenbrook TMS Inc. (the “Company”) entered into a research collaboration agreement (the “Research
Collaboration Agreement”) with Compass Pathways plc, a corporation registered in England and Wales (“Compass”)
to explore delivery models for investigational COMP360 psilocybin treatment ("COMP360") upon regulatory approval by the
U.S. Food and Drug Administration (“FDA”). The collaboration will research and investigate models for the delivery
of scalable, commercial COMP360, within healthcare systems, assuming FDA-approval.
As
part of the Research Collaboration Agreement, the Company and Compass plan to enter into mutually agreeable collaboration plans (the “Collaboration
Plans”) in order to further their mutual goals around improving health outcomes, lowering the cost of care, and improving the
patient and provider experiences. The first Collaboration Plan is included in the Research Collaboration Agreement, (the “Initial
Collaboration Plan”), is effective as of December 29, 2023, and will comprise research into the delivery model, assuming FDA
approval, of COMP360 at treatment centers across the United States, such as through Greenbrook TMS’s current network of treatment
centers, working with their patient populations, which include people suffering from treatment-resistant depression, and other mental
health conditions. The Initial Collaboration Plan is expected to be completed by December 2026.
The
Initial Collaboration Plan outlines a series of milestones for the Company. Each milestone involves deliverables from the Company, which
include, among other things, committing a number of personnel to the Initial Collaboration Plan; and a number of patients and staff enrolled
in Compass’ digital tools and continued engagement with the tools. In return for meeting the deliverables set forth in the Initial
Collaboration Plan, the Company has the opportunity to earn up to $3,000,0000 in compensation from Compass between the effective date
of the Initial Collaboration Plan and completion of the Initial Collaboration Plan. Of the $3,000,000 issuable under the Initial Collaboration
Plan, the Company has received $1,300,000 to date, in anticipation of meeting the initial milestones.
The
Research Collaboration Agreement will expire on the later of (a) December 31, 2026, or (b) the termination of the last collaboration program
executed by the parties prior to the third anniversary of December 29, 2023. The Research Collaboration Agreement can also be terminated
earlier via 30 days’ notice by either party, as well as upon breach or mutual termination. The Research Collaboration Agreement
may also be extended by mutual agreement of the parties.
The
Research Collaboration Agreement and associated Collaboration Plans are limited to research and collaboration and does not provide for
commercialization.
A
copy of the Research Collaboration Agreement will be filed as an exhibit to the Company’s annual report on Form 10-K for the year
ended December 31, 2023. Pursuant to Item 601(b)(10)(iv) of Regulation S-K, the Company intends to redact from the filed copy of the Research
Collaboration Agreement certain information that is both (i) not material and (ii) is the type of information that the Company treats
as private or confidential.
Certain
statements contained in this Current Report on Form 8-K, including statements relating to the Initial Collaboration Plan, the expected
completion of such plan and expected compensation to be received thereunder, may constitute “forward-looking information”
within the meaning of applicable securities laws in Canada and “forward-looking statements” within the meaning of the United
States Private Securities Litigation Reform Act of 1995 (collectively, “forward-looking information”). Forward-looking
information may relate to the Company’s future financial and liquidity outlook and anticipated events or results and may include
information regarding the Company’s business, financial position, results of operations, business strategy, growth plans and strategies,
technological development and implementation, budgets, operations, financial results, taxes, dividend policy, plans and objectives. Particularly,
information regarding the Initial Collaboration Plan, the expected completion of such plan and expected compensation to be received thereunder
may be forward-looking information. In some cases, forward-looking information can be identified by the use of forward-looking terminology
such as “plans”, “targets”, “expects” or “does not expect”, “is expected”,
“an opportunity exists”, “budget”, “scheduled”, “estimates”, “outlook”, “forecasts”,
“projection”, “prospects”, “strategy”, “intends”, “anticipates”, “does
not anticipate”, “believes”, or variations of such words and phrases or statements that certain actions, events or results
“may”, “should”, “could”, “would”, “might”, “will”, “will
be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, intentions,
projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking
information are not facts but instead represent management’s expectations, estimates and projections regarding future events or
circumstances.
Forward-looking
information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as
of the date of this Current Report on Form 8-K, are subject to known and unknown risks, uncertainties, assumptions and other factors that
may cause the actual results, level of activity, performance or achievements or future events or developments to differ materially from
those expressed or implied by the forward-looking statements, including, without limitation: macroeconomic factors such as inflation and
recessionary conditions, substantial doubt regarding the Company’s ability to continue as a going concern due to recurring losses
from operations; inability to increase cash flow and/or raise sufficient capital to support the Company’s operating activities and
fund its cash obligations, repay indebtedness and satisfy the Company’s working capital needs and debt obligations; prolonged decline
in the price of the Company’s common shares (the “Common Shares”) reducing the Company’s ability to raise
capital; inability to satisfy debt covenants under the Company’s credit facility with Madryn Fund Administration LLC (the “Credit
Facility”) and the potential acceleration of indebtedness; risks related to the resolution of the Company’s ongoing litigation
with Benjamin Klein and compliance with the terms of their settlement agreement; risks related to the ability to continue to negotiate
amendments to the Credit Facility to prevent a default; risks relating to the Company’s ability to deliver and execute on the previously-announced
restructuring plan (the “Restructuring Plan”) and the possible failure to complete the Restructuring Plan on terms
acceptable to the Company or its suppliers (including Neuronetics, Inc.), or at all; risks relating to maintaining an active, liquid and
orderly trading market for Common Shares as a result of the Company’s recent delisting notification and potential inability to regain
compliance with the Nasdaq Stock Market’s listing rules; risks relating to the Company’s ability to realize expected cost-savings
and other anticipated benefits from the Restructuring Plan; risks related to the Company’s negative cash flows, liquidity and its
ability to secure additional financing; increases in indebtedness levels causing a reduction in financial flexibility; inability to achieve
or sustain profitability in the future; inability to secure additional financing to fund losses from operations and satisfy the Company’s
debt obligations; risks relating to strategic alternatives, including restructuring or refinancing of the Company’s debt, seeking
additional debt or equity capital, reducing or delaying the Company’s business activities and strategic initiatives, or selling
assets, other strategic transactions and/or other measures, including obtaining bankruptcy protection, and the terms, value and timing
of any transaction resulting from that process; claims made by or against the Company, which may be resolved unfavorably to us; risks
relating to the Company’s dependence on Neuronetics, Inc. as its exclusive supplier of TMS devices. Additional risks and uncertainties
are discussed in the Company’s materials filed with the Canadian securities regulatory authorities and the United States Securities
and Exchange Commission from time to time, available at www.sedarplus.com and www.sec.gov, respectively. These factors are not intended
to represent a complete list of the factors that could affect the Company; however, these factors should be considered carefully. There
can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this Current
Report on Form 8-K are made as of the date of this report, and the Company expressly disclaims any obligation to update or alter statements
containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future
events or otherwise, except as required by law.
| Item 7.01 | Regulation FD Disclosure. |
On
January 5, 2024, the Company and Compass issued a joint press release announcing that it had entered into the Research Collaboration Agreement
and the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The
information contained in this Current Report on Form 8-K under Item 7.01, including the attached Exhibit 99.1, is being furnished pursuant
to Item 7.01 of Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of
1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information contained
in this Current Report on Form 8-K under Item 7.01, shall not be incorporated by reference into any filing under the Securities Act of
1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific
reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
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 5, 2024
|
Greenbrook TMS Inc. |
|
|
|
|
By: |
/s/ Bill Leonard |
|
Name: |
Bill Leonard |
|
Title: |
President & Chief Executive Officer |
Exhibit 99.1
Compass Pathways and Greenbrook TMS enter into three-year research collaboration agreement
Three-year research collaboration will investigate
the development of scalable, commercial delivery models for COMP360 psilocybin treatment, if FDA-approved
January 5, 2024
Compass Pathways plc (Nasdaq: CMPS) (“Compass”),
a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Greenbrook TMS Inc.
(NASDAQ: GBNH) (“Greenbrook TMS”), a leading provider of Transcranial Magnetic Stimulation and Spravato® (esketamine
nasal spray)—FDA-cleared, non-invasive therapies for the treatment of major depressive disorder and other mental health disorders,
in the United States—today jointly-announced that they have entered into a three-year research collaboration agreement to explore
delivery models for investigational COMP360 psilocybin treatment ("COMP360") upon regulatory approval by the U.S. Food and Drug
Administration (“FDA”).
The collaboration will research and investigate
models for the delivery of scalable, commercial COMP360 within healthcare systems, assuming FDA approval. The initial phase of the collaboration
will comprise research into the delivery of COMP360 at treatment centers across the United States, such as through Greenbrook TMS’s
current network of treatment centers, working with their patient populations, which include people suffering from treatment-resistant
depression (TRD) and other mental health conditions.
In depth research will include exploring how to
improve the patient care experience and gaining a better understanding of therapist needs and investigating the potential use and integration
of digital tools within Greenbrook TMS’s existing care pathways.
COMP360 has been designated a “Breakthrough
Therapy” by the FDA for TRD. Compass has commenced a phase 3 clinical program of COMP360 in TRD and intends to apply for FDA approval
upon completion of clinical trials.
“Whilst we urgently need more innovative
medicines in mental health care, it is just as essential to deliver them at pace to people in greatest need,” said Kabir Nath, Chief
Executive Officer of Compass Pathways. “We’re pleased to enter into this research collaboration with Greenbrook TMS to learn
how this can be optimized at scale and in the most cost-effective way for our healthcare systems if COMP360 receives regulatory approval.”
“We are proud to collaborate with Compass
to explore how we can bring innovative treatments to patients safely and conveniently,” Bill Leonard, President and Chief Executive
Officer of Greenbrook TMS. “Our depth of experience and nationwide presence offers a great platform for scaling new treatments that
solve issues with awareness, geographic convenience and fiscal viability. Our team excels at navigating through barriers to care so that
patients can receive and benefit from the latest therapeutics.”
-Ends-
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated
to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering
with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin
treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support.
COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing
and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
We have commenced a phase 3 clinical program
of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted.
Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant
improvement in depressive symptom severity after three weeks for patients who received a single 25mg dose of COMP360 psilocybin with psychological
support. We are also conducting phase 2 clinical studies of COMP360 psilocybin treatment for post-traumatic stress disorder (PTSD) and
anorexia nervosa.
Compass is headquartered in London, UK, with
offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. www.compasspathways.com
About Greenbrook TMS
Operating through 130 company-operated treatment
centers, Greenbrook TMS is a leading provider of Transcranial Magnetic Stimulation (“TMS”) therapy and Spravato® (esketamine
nasal spray), FDA-cleared, non-invasive therapies for the treatment of Major Depressive Disorder (“MDD”) and other mental
health disorders, in the United States. TMS therapy provides local electromagnetic stimulation to specific brain regions known to be directly
associated with mood regulation. Spravato® is offered to treat adults with treatment-resistant depression and depressive symptoms
in adults with MDD with suicidal thoughts or actions. Greenbrook TMS has provided more than 1.3 million treatments to over 40,000 patients
struggling with depression.
Availability of other information about
Compass Pathways
Investors and others should note that Compass
communicates with its investors and the public using its website (www.compasspathways.com), its investor relations website (ir.compasspathways.com),
and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange
Commission filings, press releases, public conference calls and webcasts. The information that Compass posts on these channels and websites
could be deemed to be material information. As a result, Compass encourages investors, the media, and others interested in Compass to
review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels
may be updated from time to time on Compass’s investor relations website and may include additional social media channels. The contents
of Compass’s website or these channels, or any other website that may be accessed from Compass’s website or these channels,
shall not be deemed incorporated by reference in any filing under the United States Securities Act of 1933, as amended.
Forward-looking statements
Compass Pathways:
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology
such as “may”, “will”, “could”, “would”, “expect”, “intend”, “plan”,
“anticipate”, “believe”, “potential” and “continue” and “ongoing,” or the
negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking
statements include express or implied statements relating to, among other things, the safety or efficacy of investigational COMP360 psilocybin
treatment as a treatment for depression, post-traumatic stress disorder or anorexia nervosa, the potential for the pivotal phase 3 program
or other trials to support regulatory filings and approvals, Compass’s business strategy and goals, Compass’s plans, expectations
and ability to achieve its goals related to this research collaboration agreement; Compass’s ability to continue to advance its
research, obtain regulatory approval or develop plans to bring COMP360 psilocybin treatment to patients, and Compass’s expectations
regarding the benefits of its investigational COMP360 psilocybin treatment. The forward-looking statements in this press release are neither
promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown
risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels
of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
These risks, uncertainties, and other factors include, among others:
clinical development is lengthy and outcomes are uncertain, and therefore Compass’s clinical trials may be delayed or terminated;
the results early-stage clinical trials of investigational COMP360 psilocybin treatment may not be predictive of the results of later
stage clinical trials; Compass’s efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction
for COMP360 or any of future product candidates may be unsuccessful, and Compass’s efforts to obtain coverage and reimbursement
for its investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that this research collaboration with
Greenbrook TMS will not continue or will not be successful; Greenbrook TMS’s willingness or ability to complete its obligations
under the research collaboration agreement may be adversely affected by business combinations, restructurings or other corporate transactions,
worsening of its financial position or significant changes in its strategy; and those risks and uncertainties described under the heading
“Risk Factors” in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports
we have filed with the U.S. Securities and Exchange Commission (“SEC”) , which are available on the SEC’s website at
www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking
statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements
are based on Compass’s current expectations and speak only as of the date hereof.
Greenbrook TMS:
Certain statements contained in this press release, including statements
relating to the research collaboration with Compass Pathways, the status of COMP360 regulatory approvals and the potential introduction
of COMP360 psilocybin treatment at Greenbrook TMS centers, may constitute “forward-looking information” within the meaning
of applicable securities laws in Canada and “forward-looking statements” within the meaning of the United States Private Securities
Litigation Reform Act of 1995 (collectively, “forward-looking information”). Forward-looking information may also relate to
anticipated events or results and may include information regarding Greenbrook TMS’s business, financial position, results of operations,
business strategy, growth plans and strategies, technological development and implementation, budgets, operations, financial results,
taxes, dividend policy, plans and objectives. Particularly, information regarding the research collaboration with Compass Pathways and
COMP360 psilocybin treatment, may be forward-looking information. In some cases, forward-looking information can be identified by the
use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”,
“is expected”, “an opportunity exists”, “budget”, “scheduled”, “estimates”,
“outlook”, “forecasts”, “projection”, “prospects”, “strategy”, “intends”,
“anticipates”, “does not anticipate”, “believes”, or variations of such words and phrases or statements
that certain actions, events or results “may”, “should”, “could”, “would”, “might”,
“will”, “will be taken”, “occur” or “be achieved”. In addition, any statements that refer
to expectations, intentions, projections or other characterizations of future events or circumstances contain forward-looking information.
Statements containing forward-looking information are not facts but instead represent management’s expectations, estimates and projections
regarding future events or circumstances.
Forward-looking information is necessarily based on a number of
opinions, assumptions and estimates that, while considered reasonable by Greenbrook TMS as of the date of this press release, are
subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of
activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the
forward-looking statements, including, without limitation: risks relating to regulatory approval of COMP360
psilocybin treatment and Greenbrook TMS’s ability to successfully execute its research collaboration with Compass
Pathways; macroeconomic factors such as inflation and recessionary conditions, substantial doubt regarding Greenbrook TMS’s
ability to continue as a going concern due to recurring losses from operations; inability to increase cash flow and/or raise
sufficient capital to support Greenbrook TMS’s operating activities and fund its cash obligations, repay indebtedness and
satisfy Greenbrook TMS’s working capital needs and debt obligations; prolonged decline in the price of Greenbrook TMS’s
common shares (“Common Shares”) reducing Greenbrook TMS’s ability to raise capital; inability to satisfy debt
covenants under Greenbrook TMS’s credit facility (the “Credit Facility”) and the potential acceleration of
indebtedness; risks related to the resolution of Greenbrook TMS’s ongoing litigation with Benjamin Klein and compliance with
the terms of their settlement agreement; risks related to the ability to continue to negotiate amendments to the Credit Facility to
prevent a default; risks relating to Greenbrook TMS’s ability to deliver and execute on the previously-announced restructuring
plan (the “Restructuring Plan”) and the possible failure to complete the Restructuring Plan on terms acceptable to
Greenbrook TMS or its suppliers (including Neuronetics, Inc.), or at all; risks relating to maintaining an active, liquid and
orderly trading market for Common Shares as a result of Greenbrook TMS’s recent delisting notification and potential inability
to regain compliance with the Nasdaq Stock Market’s listing rules; risks relating to Greenbrook TMS’s ability to realize
expected cost-savings and other anticipated benefits from the Restructuring Plan; risks related to Greenbrook TMS’s negative
cash flows, liquidity and its ability to secure additional financing; increases in indebtedness levels causing a reduction in
financial flexibility; inability to achieve or sustain profitability in the future; inability to secure additional financing to fund
losses from operations and satisfy Greenbrook TMS’s debt obligations; risks relating to strategic alternatives, including
restructuring or refinancing of Greenbrook TMS’s debt, seeking additional debt or equity capital, reducing or delaying
Greenbrook TMS’s business activities and strategic initiatives, or selling assets, other strategic transactions and/or other
measures, including obtaining bankruptcy protection, and the terms, value and timing of any transaction resulting from that process;
claims made by or against Greenbrook TMS, which may be resolved unfavorably to us; risks relating to Greenbrook TMS’s
dependence on Neuronetics, Inc. as its exclusive supplier of TMS devices. Additional risks and uncertainties are discussed in
Greenbrook TMS’s materials filed with the Canadian securities regulatory authorities and the United States Securities and
Exchange Commission from time to time, available at www.sedarplus.ca and www.sec.gov, respectively. These factors are not intended
to represent a complete list of the factors that could affect Greenbrook TMS; however, these factors should be considered carefully.
There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in
this press release are made as of the date of this press release, and Greenbrook TMS expressly disclaims any obligation to update or
alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of
new information, future events or otherwise, except as required by law.
Enquiries
Compass Pathways:
Media: Amy Lawrence, media@compasspathways.com,
+44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com,
+1 401 290 7324
Greenbrook TMS:
Glen Akselrod, Investor Relations
Contact Information: investorrelations@greenbrooktms.com
1-855-797-4867
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