TIDMVRP
Funding to support Phase 3 ENHANCE clinical program in COPD
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF
ARTICLE 7 OF THE MARKET ABUSE REGULATION (EU) NO. 596/2014 ("MAR"). UPON
PUBLICATION OF THIS ANNOUNCEMENT THIS INFORMATION IS NOW CONSIDERED IN
THE PUBLIC DOMAIN.
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN OR
INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A
VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION. NEITHER THIS
ANNOUNCEMENT, NOR ANYTHING CONTAINED HEREIN, SHALL FORM THE BASIS OF, OR
BE RELIED UPON IN CONNECTION WITH, ANY OFFER OR COMMITMENT WHATSOEVER IN
ANY JURISDICTION.
LONDON and RALEIGH, N.C., July 17, 2020 (GLOBE NEWSWIRE) -- Verona
Pharma plc (AIM: VRP) (Nasdaq: VRNA) ("Verona Pharma" or the "Company"),
a clinical-stage biopharmaceutical company focused on respiratory
diseases, announces it has raised approximately $200 million (GBP159
million*) in an oversubscribed private placement and subscription with
new and existing institutional and accredited investors (the
"Financing"). The Financing comprises a private placement of 39,090,009
of the Company's American Depositary Shares ("ADSs"), each representing
eight ordinary shares of the Company ("Ordinary Shares"), at a price of
$4.50 per ADS, and 43,111,112 of the Company's Ordinary Shares at the
equivalent price per Ordinary Share, being GBP0.45 or $0.5625 (together
the "Securities").
Verona Pharma anticipates net proceeds of the Financing will be
approximately $183 million after deducting placement agent fees and
estimated expenses.
The Financing was led by new investors RA Capital Management, Access
Biotechnology, Perceptive Advisors, Acorn Bioventures, PBM Capital,
Samsara BioCapital, Foresite Capital, Sphera, Fairmount and Soleus
Capital, as well as additional investors. Existing investors, OrbiMed,
New Enterprise Associates (NEA), Vivo Capital, Abingworth, Novo Holdings
A/S, Polar Capital and Aisling Capital also participated.
Jefferies LLC ("Jefferies") is acting as the lead placement agent to the
Company in connection with the Financing.
Verona Pharma intends to use the net proceeds from the Financing
primarily to fund its Phase 3 clinical program ENHANCE (Ensifentrine as
a Novel inHAled Nebulized COPD thErapy) in chronic obstructive pulmonary
disease (COPD) and for general corporate purposes. The Phase 3 clinical
trials are planned to start later in 2020.
"We are extremely pleased to have received support from this group of
highly experienced life science investors who understand the potential
benefit of ensifentrine for patients with COPD," said David Zaccardelli,
Pharm. D., President and CEO of Verona Pharma. "With this financing we
plan to initiate our Phase 3 ENHANCE clinical trials later this year and
expect to support our programs into 2023. This important milestone
brings us closer to our goal of ensuring ensifentrine is available for
millions of COPD patients who urgently need additional treatment
options."
Director Interests
In connection with the Financing, certain Directors and an Officer of
the Company (the "Participating Directors and Officer") intend to
subscribe for new ordinary shares or ADSs at the applicable price per
ordinary share or per ADSs to contribute, in aggregate, gross proceeds
of approximately $955,000.
Each of the Participating Directors and Officer has agreed to
participate in the Financing by acquiring such number of Securities at
the applicable price (rounded down to the nearest whole share) as is
equal to the following participation amounts:
Director Name Title Participation Amount
--------------------- --------- --------------------
GBP100,000
David Ebsworth Chairman ($125,000)*
--------------------- --------- --------------------
David Zaccardelli CEO $250,000
--------------------- --------- --------------------
Vikas Sinha
(connected persons) Director $300,000
--------------------- --------- --------------------
Anders Ullman Director $150,000
--------------------- --------- --------------------
Martin Edwards Director $30,000
--------------------- --------- --------------------
Mark Hahn CFO $100,000
--------------------- --------- --------------------
Further dealing disclosures will be made in accordance with MAR in
respect of the above transactions by Persons Discharging Managerial
Responsibility (PDMR).
Related Party Transactions
As of July 15, 2020, Novo Holdings A/S and Vivo Capital held
approximately 11.63 per cent and 11.21 per cent, respectively, of Verona
Pharma's issued ordinary share capital and as such each is considered to
be a related party of the Company as defined in the AIM Rules for
Companies. The participations by Novo Holdings A/S and Vivo Capital in
the Financing are deemed to each constitute a related party transaction
pursuant to AIM Rule 13 (the "Related Party Transactions").
The Independent Directors (being for this purpose the directors of the
Company other than the Participating Directors and Dr Mahendra Shah
appointed by Vivo Capital) consider, having consulted with N+1 Singer,
the Company's nominated adviser for the purposes of the AIM Rules, that
the terms of each of the Related Party Transactions are fair and
reasonable insofar as the shareholders of the Company are concerned.
Restriction on further issue of securities
The Company has undertaken to the investors that, between July 16, 2020
and 90 calendar days after Closing, it will not, without the prior
written consent of Jefferies, directly or indirectly issue or allot any
Ordinary Shares or equivalent securities, subject to customary
exceptions and waiver by Jefferies.
Further details of Financing
The Securities will represent 77.0% of the issued share capital as
enlarged for the Financing. The issue price of the Securities represents
a discount of approximately 4.7% to the closing mid-market price of
$4.72 per ADS on July 15, 2020, being the last practicable date before
the pricing of the Financing. The issuance of the Securities is being
made under the Company's existing authority to issue new securities on a
non pre-emptive basis, as granted at the recent Annual General Meeting
of shareholders on April 16, 2020.
The issuance of the Securities is expected to close on July 22, 2020
("Closing"). Of the Securities, 312,720,080 of the Securities will be
voting Ordinary Shares represented by 39,090,009 ADSs, 222,216 will be
voting Ordinary Shares, and 42,888,896 will be non-voting Ordinary
Shares. Application is expected to be made to the London Stock Exchange
for the voting Ordinary Shares to be admitted to trading on AIM
("Admission") at 0800 BST on July 23, 2020. A further announcement will
be made confirming Closing and Admission.
Important Information
The offer and sale of the foregoing securities are being made in a
transaction not involving a public offering and have not been registered
under the Securities Act of 1933, as amended (the "Securities Act"), or
applicable state securities laws, and will be sold in a private
placement pursuant to Section 4(a)(2) and Regulation D of the Securities
Act. The securities being issued in the Financing may not be offered or
sold in the United States absent registration or pursuant to an
exemption from the registration requirements of the Securities Act and
applicable state securities laws. Verona Pharma has agreed to file a
registration statement with the Securities and Exchange Commission
("SEC") registering the resale of the ADSs sold in the Financing.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy the securities, nor shall there be any
sale of the securities in any state in which such offer or sale would be
unlawful prior to the registration or qualification under the securities
laws of such state.
*The conversion of pounds sterling to U.S. dollars in this press release
is based on an exchange rate of GBP0.7973 per US$1.00 as of July 15,
2020.
About Ensifentrine
Ensifentrine (RPL554) is an investigational, first-in-class, inhaled,
dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4).
This dual inhibition enables it to combine both bronchodilator and
anti-inflammatory effects in one compound. Ensifentrine has demonstrated
significant and clinically meaningful improvements in both lung function
and COPD symptoms, including breathlessness, in Verona Pharma's prior
Phase 2 clinical studies in patients with moderate to severe COPD. In
addition, nebulized ensifentrine showed further improved lung function
and reduced lung volumes in patients taking standard short- and
long-acting bronchodilator therapy, including maximum bronchodilator
treatment with dual/triple therapy. Ensifentrine has been well tolerated
in clinical trials involving more than 1,300 people to date.
About Verona Pharma
Verona Pharma is a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative therapies for the treatment of
respiratory diseases with significant unmet medical needs. If
successfully developed and approved, Verona Pharma's product candidate,
ensifentrine, has the potential to be the first therapy for the
treatment of respiratory diseases that combines bronchodilator and
anti-inflammatory activities in one compound. Following a response from
the U.S. FDA to Verona Pharma's End-of-Phase 2 briefing package, the
Company is accelerating preparations for the Phase 3 clinical program
ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) to
start later in 2020. Verona Pharma is currently in Phase 2 development
with two additional formulations of ensifentrine for the treatment of
COPD: dry powder inhaler and pressurized metered-dose inhaler.
Ensifentrine also has potential applications in cystic fibrosis, asthma
and other respiratory diseases. For more information, please visit
www.veronapharma.com
Forward-Looking Statements
This press release contains forward-looking statements. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including, but not limited to, the anticipated net proceeds from the
Financing and the use of those proceeds, the sufficiency of the
Financing to support initiation of the Phase 3 program and programs into
2023, the goal of ensifentrine being available to millions of COPD
patients, the intention of certain Directors and an Officer to subscribe
for Securities and the aggregate amount they are expected to contribute,
the timing of closing of the Financing and admission of the Ordinary
Shares to AIM, the progress and timing of initiation of clinical trials,
the potential for ensifentrine to be a first-in-class phosphodiesterase
3 and 4 inhibitor and to be the first therapy for the treatment of
respiratory diseases to combine bronchodilator and anti-inflammatory
effects in one compound, and the potential of ensifentrine in the
treatment of COPD, cystic fibrosis, asthma and other respiratory
diseases.
These forward-looking statements are based on management's current
expectations. These statements are neither promises nor guarantees, but
involve known and unknown risks, uncertainties and other important
factors that may cause our actual results, performance or achievements
to be materially different from our expectations expressed or implied by
the forward-looking statements, including, but not limited to, the
following: our limited operating history; our need for additional
funding to complete development and commercialization of ensifentrine,
which may not be available and which may force us to delay, reduce or
eliminate our development or commercialization efforts; the reliance of
our business on the success of ensifentrine, our only product candidate
under development; economic, political, regulatory and other risks
involved with international operations; the lengthy and expensive
process of clinical drug development, which has an uncertain outcome;
serious adverse, undesirable or unacceptable side effects associated
with ensifentrine, which could adversely affect our ability to develop
or commercialize ensifentrine; potential delays in enrolling patients,
which could adversely affect our research and development efforts and
the completion of our clinical trials; we may not be successful in
developing ensifentrine for multiple indications; our ability to obtain
approval for and commercialize ensifentrine in multiple major
pharmaceutical markets; misconduct or other improper activities by our
employees, consultants, principal investigators, and third-party service
providers; our future growth and ability to compete depends on retaining
our key personnel and recruiting additional qualified personnel;
material differences between our "top-line" data and final data; our
reliance on third parties, including clinical research organizations,
clinical investigators, manufacturers and suppliers, and the risks
related to these parties' ability to successfully develop and
commercialize ensifentrine; and lawsuits related to patents covering
ensifentrine and the potential for our patents to be found invalid or
unenforceable; and our vulnerability to natural disasters, global
economic factors and other unexpected events, including health epidemics
or pandemics like the novel coronavirus (COVID-19). These and other
important factors under the caption "Risk Factors" in our Annual Report
on Form 20-F filed with the SEC on February 27, 2020, and our other
reports filed with the SEC, could cause actual results to differ
materially from those indicated by the forward-looking statements made
in this press release. Any such forward-looking statements represent
management's estimates as of the date of this press release. While we
may elect to update such forward-looking statements at some point in the
future, we disclaim any obligation to do so, even if subsequent events
cause our views to change. These forward-looking statements should not
be relied upon as representing our views as of any date subsequent to
the date of this press release.
For further information, please contact:
Verona Pharma plc Tel: +44 (0)20 3283 4200
David Zaccardelli, Chief Executive Officer info@veronapharma.com
Victoria Stewart, Director of Communications
N+1 Singer Tel: +44 (0)20 3283 4200
(Nominated Adviser and UK Broker)
Aubrey Powell / George Tzimas / Iqra Amin (Corporate
Finance)
Tom Salvesen (Corporate Broking)
Optimum Strategic Communications Tel: +44 (0)203 950 9144
(European Media and Investor Enquiries) verona@optimumcomms.com
Mary Clark / Eva Haas / Shabnam Bashir
Argot Partners Tel: +1 212-600-1902
(US Investor Enquiries) mailto:verona@argotpartners.com verona@argotpartners.com
---------------------------------------------------------
Kimberly Minarovich / Michael Barron
(END) Dow Jones Newswires
July 17, 2020 02:00 ET (06:00 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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