- Proceeds from strategic financing
together with year-end cash resources expected to fund operations
into mid-2025 including etripamil NDA submission and launch in
PSVT
- The combination of etripamil's strong
clinical results with this strategic financing lays the foundation
to deliver a therapy that empowers patients to treat
supraventricular tachycardia attacks outside the emergency
department
MONTREAL and CHARLOTTE,
N.C., March 28, 2023 /PRNewswire/ -- Milestone
Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company
focused on the development and commercialization of innovative
cardiovascular medicines, today announced that it has entered into
a $125 million strategic funding
agreement with existing shareholder, RTW Investments, LP and
certain of its affiliates ("RTW"). Proceeds from this tailored
financing, together with $64.6
million of cash, cash equivalents and short-term investments
as of December 31, 2022, are expected
to fund Milestone's operations into the middle of 2025, including
the potential approval and launch of etripamil. Etripamil is the
Company's investigational calcium channel blocker envisioned to
empower patients with paroxysmal supraventricular tachycardia
(PSVT) to treat their attacks outside of the emergency
department.
The strategic financing was anchored by RTW's purchase of
$50 million in convertible notes, as
well as a commitment of $75 million
in non-dilutive royalty funding, which, together, the Company
expects will support the NDA submission and subsequent launch of
etripamil for patients with PSVT. If approved, etripamil is
intended to give health care providers a new tool to enable patient
self-management. Etripamil has the potential to provide the patient
with a greater sense of control over their PSVT, a condition marked
by highly symptomatic, unpredictable, and burdensome episodes of
cardiac arrhythmia. The Company plans to submit a New Drug
Application to the U.S. Food and Drug Administration in the third
quarter of 2023.
"Etripamil has demonstrated strong potential to offer patients a
meaningful intervention for the treatment of PSVT outside of the
costly and inconvenient acute-care setting and we are highly
encouraged by the results of the Phase 3 RAPID study in
October 2022," said Roderick Wong, MD, Managing Partner and Chief
Investment Officer of RTW Investments, LP. "We are excited to
expand our partnership with the convertible note and royalty
financings to continue to support Milestone's effort to advance
etripamil to a potential U.S. regulatory approval and future
commercialization efforts."
"As we continue on our mission of delivering this much needed
therapeutic option to patients suffering from episodic
cardiovascular conditions, it is a privilege to partner with RTW on
these strategic financings, which we believe further validate the
value of etripamil," said Amit
Hasija, Chief Financial Officer and Executive Vice President
of Corporate Development at Milestone.
RTW has extended its investment relationship with Milestone by
purchasing $50 million of senior
secured convertible promissory notes (the "Notes") in a private
placement transaction. The Notes are convertible into common shares
of Milestone at an initial conversion price of $5.23 per share, which represents a 50% premium
over the volume-weighted average price of Milestone's common shares
over the trailing 30-trading day period ending on March 27, 2023. Funds from the Notes will be
immediately available upon closing.
The Notes will be senior secured obligations of Milestone and
will accrue interest at a rate of 6.0% per annum, payable quarterly
in arrears, with the option to be paid in kind for the first three
years at Milestone's election. The Notes will mature on
March 31, 2029, unless earlier
redeemed, converted or repurchased. Holders will have the right to
convert their Notes at any time prior to the close of business on
the second trading day immediately preceding the Notes' maturity
date. Milestone will settle conversions solely in shares of its
common shares, except for payments of cash in lieu of fractional
shares.
In addition, under the terms of the revenue financing agreement,
subject to customary closing conditions and subject to FDA approval
of etripamil, RTW provided a $75
million non-dilutive synthetic royalty financing commitment
to Milestone in return for tiered rate, cash royalty payments based
on aggregate net sales of etripamil within the United States. RTW will receive royalty
rates ranging from high to low single digits based on certain
annual sales thresholds, subject to upward adjustment if certain
annual sales thresholds are not met. Royalty funds become available
upon FDA approval of etripamil for PSVT, and satisfaction of other
customary conditions.
The offer and sale of the Notes and any common shares issuable
upon conversion of the Notes have not been registered under the
Securities Act of 1933, as amended (the "Securities Act"), or any
other securities laws, and the Notes and any such shares cannot be
offered or sold except pursuant to an exemption from, or in a
transaction not subject to, the registration requirements of the
Securities Act and any other applicable securities laws. This press
release does not constitute an offer to sell, or the solicitation
of an offer to buy, the Notes or any common shares issuable upon
conversion of the Notes, nor will there be any sale of the Notes or
any such common shares, in any state or other jurisdiction in which
such offer, sale or solicitation would be unlawful.
Cowen acted as financial advisor to Milestone on the financing
transactions. Cooley acted as legal advisor to Milestone. Gibson
Dunn acted as legal advisor to
RTW.
About Milestone Pharmaceuticals Inc.
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a
biopharmaceutical company focused on the development and
commercialization of innovative cardiovascular medicines.
Milestone's lead product candidate etripamil recently completed its
Phase 3 clinical-stage program for the treatment of paroxysmal
supraventricular tachycardia (PSVT) and is in a Phase 2
proof-of-concept trial for the treatment of patients with atrial
fibrillation with rapid ventricular rate (AFib-RVR). Milestone
Pharmaceuticals operates in Canada
and the United States. For more
information, visit www.milestonepharma.com and follow Milestone on
Twitter at @MilestonePharma.
About RTW Investments, LP
RTW Investments, LP is a New
York-based, global, full life-cycle investment firm that
focuses on identifying transformational and disruptive innovations
across the biopharmaceutical and medical technologies sectors. As a
leading partner of industry and academia, RTW combines deep
scientific expertise with a solution-oriented investment approach
to advance emerging medical therapies by building and supporting
the companies and/or academics developing them. For further
information about RTW, please visit www.rtwfunds.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "believe," "continue," "could," "demonstrate,"
"designed," "develop," "estimate," "expect," "may," "pending,"
"plan," "potential," "progress," "will" and similar expressions (as
well as other words or expressions referencing future events,
conditions or circumstances) are intended to identify
forward-looking statements. These forward-looking statements are
based on Milestone's expectations and assumptions as of the date of
this press release. Each of these forward-looking statements
involves risks and uncertainties. Actual results may differ
materially from these forward-looking statements. Forward-looking
statements contained in this press release include statements
regarding the closing of the transactions on the terms provided, or
at all (including whether the closing conditions to the revenue
interest financing will be met); future cash payments based on
aggregate net sales of the Etripamil, the potential of etripamil to
serve as a promising therapy for PSVT patients; Milestone's ability
to execute on the remainder of the PSVT program; and the
sufficiency of Milestone's current cash resources to support its
operations.
Important factors that could cause actual results to differ
materially from those in the forward-looking statements include,
but are not limited to, the risks inherent in biopharmaceutical
product development and clinical trials, including the lengthy and
uncertain regulatory approval process; uncertainties related to the
timing of initiation, enrollment, completion, evaluation and
results of our clinical trials; risks and uncertainty related to
the complexity inherent in cleaning, verifying and analyzing trial
data; and whether the clinical trials will validate the safety and
efficacy of etripamil for PSVT; or other indications, among others,
general economic, political, and market conditions, including
deteriorating market conditions due to investor concerns regarding
inflation and Russian hostilities in Ukraine and overall fluctuations in the
financial markets in the United
States and abroad, risks related to pandemics and public
health emergencies, including those related to the ongoing COVID-19
pandemic, and risks related the sufficiency of Milestone's capital
resources and its ability to raise additional capital. These and
other risks are set forth in Milestone's filings with the U.S.
Securities and Exchange Commission, including in quarterly report
for the fiscal quarter ended September 30,
2022, under the caption "Risk Factors," as such discussion
may be updated from time to time by subsequent filings we may make
with the U.S. Securities & Exchange Commission. Except as
required by law, Milestone assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
Contact:
David Pitts
Argot Partners
milestone@argotpartners.com
212-600-1902
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SOURCE Milestone Pharmaceuticals, Inc.