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 (£159 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 £0.45 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 |
David Ebsworth |
Chairman |
£100,000 ($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
£0.7973 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 (Nominated Adviser and UK Broker) |
Tel: +44 (0)20 3283 4200 |
Aubrey Powell / George Tzimas / Iqra Amin (Corporate Finance) |
|
Tom Salvesen (Corporate Broking) |
|
|
|
Optimum Strategic Communications (European Media
and Investor Enquiries) |
Tel: +44 (0)203 950 9144 verona@optimumcomms.com |
Mary Clark / Eva Haas / Shabnam Bashir |
|
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|
Argot Partners (US Investor Enquiries) |
Tel: +1 212-600-1902 verona@argotpartners.com |
Kimberly Minarovich / Michael Barron |
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