Notice of Preliminary
Results
Mereo BioPharma Group plc (AIM: MPH), a clinical stage, UK-based,
biopharmaceutical company focused on rare diseases, announces that
the merger with OncoMed Pharmaceuticals, Inc. ("OncoMed"
NASDAQ:OMED) announced on 5 December 2018 has today completed.
This follows the approval from the stockholders
of OncoMed on 17 April 2019 of the transactions contemplated by the
merger agreement dated 5 December 2018 (the "Merger") between
Mereo, OncoMed and certain other parties thereto (the “Merger
Agreement”), and OncoMed has today become a wholly-owned indirect
subsidiary of Mereo following the effective filing of a certificate
of merger with the Secretary of State of the State of Delaware. In
connection with completion of the Merger:
- Mereo has today issued 24,783,320 new ordinary shares (the “New
Shares”) to Citibank, N.A., London Branch, as custodian, and will
instruct Citibank, N.A., as depositary, to deliver 4,956,664
American Depositary Shares (the "ADSs") to former OncoMed
stockholders, each ADS representing five New Shares. The ADSs are
expected to be admitted to trading on the Global Market of Nasdaq
Stock Exchange Market LLC on 24 April 2019, under the ticker symbol
“MREO”; and
- Michael Wyzga and Deepa Pakianathan, Ph.D. today become
non-executive directors of Mereo.
Mereo also announces today that its preliminary
results for the Financial Year ended 31 December 2018 will be
published on Monday 29 April 2019.
Commenting on the announcement, Mereo's
Chief Executive Officer, Dr. Denise Scots-Knight,
said:
“We are pleased to have
completed our merger with OncoMed which has broadened our asset
base, strengthened our cash position and will enable us to further
progress our two rare disease programmes. We are delighted to
welcome both Michael and Deepa to our Board.
The ADR programme we have now initiated on
NASDAQ, together with our existing AIM listing, will facilitate a
deeper engagement with a broader international pool of capital. As
we look forward to the remainder of 2019 we continue to anticipate
several important data points from our two rare disease products.
These include initial 6 month data from the open label arm our
Phase 2b dose ranging study for BPS-804 in the treatment
osteogenesis imperfecta in Q2 2019, 12 month data for this
programme in Q4 2019 and data from our Phase 2 dose-ranging study
with MPH-966 for alpha-1 antitrypsin deficiency (AATD), which we
expect around the end of 2019.
Partnering discussions for BCT-197 for severe
exacerbations of COPD are progressing following our successful end
of Phase 2 Type B meeting with the FDA. We also intend to
initiate partnering discussions for navicixizumab, which has
generated encouraging clinical data in ovarian cancer and for
BGS-649 in hypogonadotrophic hypogonadism in parallel with the
regulatory interactions to determine the next development steps. We
look forward to updating our shareholders on the progress of our
pipeline more comprehensively on the publication of our preliminary
financial results for 2018 at the end of April.”
Issue of New Shares and Total Voting
Rights
The New Shares rank pari passu with the existing
ordinary shares of Mereo. Application has been made for the New
Shares to be admitted to trading on AIM ("Admission") and it is
expected that Admission will take place at 8.00 a.m. (BST) on 24
April 2019.
The New Shares represent approximately 25.8% of
the enlarged issued share capital of Mereo which, following the
issue, consists of an aggregate total of 96,023,592 ordinary shares
of £0.003 each, none of which are held in treasury. Shareholders
may use this figure as the denominator for the calculations by
which they will determine if they are required to notify their
interest in, or to notify a change to their interest in, the issued
share capital of Mereo.
Appointment of Michael Wyzga and Deepa
Pakianathan, Ph.D. as Non-Executive Directors of Mereo
In accordance with the Merger Agreement, Mereo
has appointed Michael Wyzga and Deepa Pakianathan, Ph.D. as
non-executive directors of Mereo.
Michael Wyzga served as a director of OncoMed
from October 2013 until the closing of the Merger today. Mr. Wyzga
is currently the President of MSW Consulting Inc., a strategic
consulting group focused in the life sciences area. From December
2011 until November 2013, Mr. Wyzga served as President and Chief
Executive Officer and a member of the board of directors of Radius
Health, Inc. Prior to that, Mr. Wyzga served in various senior
management positions at Genzyme Corporation, including as Chief
Financial Officer from July 1999 until November 2011. Mr. Wyzga is
a member of the boards of directors of Exact Sciences Corporation
and LogicBio and is Chairman of the board of directors of GenSight
Biologics S.A. and of X4 Biologics. Mr. Wyzga previously served as
a member of the boards of directors of Idenix Pharmaceuticals, Inc.
and Altus Pharmaceuticals, Inc., and as a member of the supervisory
board of Prosensa Holding B.V. He received an M.B.A. from
Providence College and a B.S. from Suffolk University.
Deepa Pakianathan, Ph.D. served as a director of
OncoMed from December 2008 until the closing of the Merger today.
Since 2001, Dr. Pakianathan has been a Managing Member at Delphi
Ventures, a venture capital firm focused on biotechnology and
medical device investments. Dr. Pakianathan serves on the boards of
directors of Alder Biopharmaceuticals, Inc., Karyopharm
Therapeutics, Inc., and Calithera Biosciences, Inc. Dr. Pakianathan
previously served on the boards of directors of Alexza
Pharmaceuticals, Inc., PTC Therapeutics, Inc. and Relypsa, Inc. Dr.
Pakianathan received a B.Sc. from the University of Bombay, India,
a M.Sc. from The Cancer Research Institute at the University of
Bombay, India, and an M.S. and Ph.D. from Wake Forest
University.
The following information is disclosed pursuant
to Schedule Two paragraph (g) of the AIM Rules for Companies.
Michael Stephen Wyzga, aged 63 years, and Deepa Rachel Pakianathan,
Ph.D., aged 54 years, have been a director of the following
companies during the five years preceding the date of this
announcement:
Michael Stephen Wyzga
Current
directorships/partnerships |
Past
directorships/partnerships |
Exact Sciences Corporation |
Idenix Pharmaceuticals, Inc |
GenSight Biologics S.A. |
Prosensa Holding B.V. |
LogicBio |
Akebia Therapeutics, Inc. |
MSW Consulting |
Aura Biosciences, Inc. |
X4 Biologics |
Dohman Co. |
|
OncoMed Pharmaceuticals, Inc. |
Deepa Rachel Pakianathan
Current
directorships/partnerships |
Past
directorships/partnerships |
Delphi Management Partners VI, LLC |
Alexza Pharmaceuticals, Inc. |
Alder Biopharmaceuticals, Inc. |
ForsightVision5 |
Calithera Biosciences, Inc. |
NeurAxon, Inc. |
Karyopharm Therapeutics, Inc. |
OncoMed Pharmaceuticals, Inc. |
Serplus Bio |
|
Save as set out above there are no further disclosures pursuant
to Rule 17 or Schedule Two paragraph (g) of the AIM Rules for
Companies in respect of the appointment of Michael Wyzga and Deepa
Pakianathan, Ph.D.
Deepa Pakianathan, Ph.D. holds a beneficial
interest in 256,734 ADSs.
About MereoMereo is a
biopharmaceutical company focused on the development and
commercialisation of innovative therapeutics that aim to improve
outcomes for patients with rare diseases. Mereo's strategy is to
selectively acquire product candidates that have substantial
preclinical, clinical and manufacturing data packages. Mereo's four
product candidates have previously generated positive clinical data
for Mereo's target indications or in related indications. Mereo has
commenced randomised Phase 2 clinical trials for all four of the
product candidates. In connection with the merger with OncoMed,
Mereo added two candidates to its pipeline, Navicixizumb and
Etigilimab.
- BPS-804 for osteogenesis imperfecta (OI). In October 2018, the
Company announced completion of enrollment of 112 adult patients in
a Phase 2b dose ranging study with initial data expected in Q2 2019
and top-line dose ranging data in late 2019. A pediatric Phase 3
study design has also been approved by the EMA. BPS-804 has orphan
designation in the U.S. and the EU and has been accepted into the
PRIME and Adaptive Pathways in EU;
- MPH-966 for alpha-1 antitrypsin deficiency (AATD). The Company
recently announced dosing of the first patient in a Phase 2 dose
ranging study in the U.S. with data expected around the end of
2019;
- BCT-197 for severe exacerbations of COPD. The Company announced
positive Phase 2 data in May 2018 and recently announced the
outline of the pivotal Phase 3 study including the primary and key
secondary endpoints following the successful end of Phase 2 Type B
meeting with the FDA;
- BGS-649 for hypogonadotropic hypogonadism (HH). The Company
announced positive top-line Phase 2b data in March 2018 and
positive results from the Phase 2b safety extension study in
December 2018;
- Navicixizumab has completed a Phase 1a single-agent clinical
trial in patients with advanced solid tumors and is currently in a
Phase 1b trial in combination with a standard paclitaxel regimen in
patients with platinum-resistant ovarian cancer. This study
recently completed enrolment; and
- Etigilimab has completed a single-agent Phase 1a trial in
patients with advanced or metastatic solid tumors and is currently
in a Phase 1b combination study with nivolumab. Etigilimab is
part of OncoMed’s prior collaboration with Celgene. Celgene has the
option to obtain an exclusive licence to develop and commercialize
the product. If Celgene exercises such option, OncoMed (now a
wholly-owned indirect subsidiary of Mereo) will be eligible to
receive a $35 million opt in payment.
A conference call to discuss the merger
and Mereo’s preliminary results will take place at 1pm (BST) on
Monday April 29 2019.
Mereo |
+44 (0)333 023
7300 |
Denise Scots-Knight, Chief
Executive Officer |
|
Richard Jones, Chief
Financial Officer |
|
|
|
Evercore
(Financial Adviser to
Mereo) |
+44 (0)20 7653
6000 |
Julian Oakley |
|
Tom Watson |
|
|
|
Cantor Fitzgerald
Europe (Nominated Adviser and Joint Broker to
Mereo) |
+44 (0)20 7894
7000 |
Phil Davies |
|
Will Goode |
|
|
|
RBC Capital
Markets (Joint Broker to
Mereo) |
+44 (0)20 7653
4000 |
Rupert WalfordJamil
Miah |
|
|
|
FTI Consulting
(Public Relations Adviser to
Mereo) |
|
Simon Conway |
+44 (0)20 3727
1000 |
Brett Pollard |
|
|
|
Burns McClellan
(US Public Relations Adviser to
Mereo) |
+01 (0) 212 213
0006 |
Lisa Burns |
|
Jill Steier |
|
Important Notice
Each of Evercore Partners International LLP
("Evercore"), Cantor Fitzgerald Europe (“Cantor Fitzgerald”) and
RBC Europe Limited (“RBC”), which is authorised and regulated in
the United Kingdom by the FCA, is acting exclusively for
Mereo and no one else in connection with the
merger and accordingly will not be responsible to anyone other than
Mereo in providing the protections afforded to
clients of Evercore, Cantor Fitzgerald or RBC (as applicable) nor
for providing advice in relation to the Merger, the content of this
announcement or any matter referred to herein. None of Evercore,
Cantor Fitzgerald or RBC nor any of its subsidiaries, branches or
affiliates owes or accepts any duty, liability or responsibility
whatsoever (whether direct or indirect, whether in contract, in
tort, under statue or otherwise) to any person who is not a client
of Evercore, Cantor Fitzgerald or RBC (as applicable) in connection
with this announcement, any statement contained herein or
otherwise.
Save for the responsibilities and liabilities,
if any, of Evercore, Cantor Fitzgerald and RBC under the Financial
Services and Markets Act 2000 or the regulatory regime established
thereunder or in respect of fraudulent misrepresentation, no
representation or warranty, express or implied, is or will be made
as to, or in relation to, and no responsibility or liability is or
will be accepted by or on behalf of Evercore, Cantor Fitzgerald or
RBC or by their respective affiliates, agents, directors, officers
and employees as to, or in relation to, the accuracy or
completeness of this announcement or any other written or oral
information made available to or publicly available to any
interested party or its advisers, and any liability therefor is
expressly disclaimed.
This announcement has been issued by and is the
sole responsibility of Mereo. The information contained in this
announcement is for background purposes only and does not purport
to be full or complete. The information in this announcement is
subject to change without notice. Subject to the AIM Rules, the UK
Disclosure Guidance and Transparency Rules and MAR, the issue of
this announcement shall not, under any circumstances, create any
implication that there has been no change in the affairs of Mereo
or OncoMed since the date of this announcement or
that the information in this announcement is correct as at any time
subsequent to the date of this announcement.
The distribution of this announcement may be
restricted by law in certain jurisdictions and persons into whose
possession this announcement, or other information referred to
herein, comes should inform themselves about and observe any such
restriction. Any failure to comply with these restrictions may
constitute a violation of the securities laws of any such
jurisdiction.
No statement in this announcement is intended to
be a profit forecast, and no statement in this announcement should
be interpreted to mean that earnings per share of Mereo for the
current or future financial years would necessarily match or exceed
the historical published earnings per share of Mereo.
Forward-Looking Statements
This communication contains "forward-looking
statements". All statements other than statements of historical
fact contained in this report are forward-looking statements within
the meaning of Section 27A of the United States Securities Act of
1933, as amended (the "Securities Act"), and Section 21E of the
United States Securities Exchange Act of 1934, as amended (the
"Exchange Act"). Forward-looking statements usually relate to
future events and anticipated revenues, earnings, cash flows or
other aspects of our operations or operating results.
Forward-looking statements are often identified by the words
"believe," "expect," "anticipate," "plan," "intend," "foresee,"
"should," "would," "could," "may," "estimate," "outlook" and
similar expressions, including the negative thereof. The absence of
these words, however, does not mean that the statements are not
forward-looking. These forward-looking statements are based on our
current expectations, beliefs and assumptions concerning future
developments and business conditions and their potential effect on
us. While management believes that these forward-looking statements
are reasonable as and when made, there can be no assurance that
future developments affecting us will be those that we
anticipate.
Factors that could cause actual results to
differ materially from those in the forward-looking statements
include failure to realise anticipated benefits of the Merger;
risks relating to unanticipated costs or liabilities associated
with of the Merger; failure or delays in research and development
programs; unanticipated changes relating to competitive factors in
the Company's industry; risks relating to expectations regarding
the capitalisation, resources and ownership structure of the
combined organisations; the availability of sufficient resources
for combined company operations and to conduct or continue planned
clinical development programs; the outcome of any legal proceedings
related to the merger; risks related to the ability to correctly
estimate operating expenses and expenses associated with the
merger; risks related to the ability to project future cash
utilisation and reserves needed for contingent future liabilities
and business operations; risks related to the Company's ability to
hire and retain key personnel; the potential impact of consummation
of the Merger on the Company's relationships with third parties;
changes in law or regulations affecting the companies;
international, national or local economic, social or political
conditions that could adversely affect the Company and its
business; conditions in the credit markets; risks associated with
assumptions the Company makes in connection with its critical
accounting estimates and other judgments.
All of our forward-looking statements involve
risks and uncertainties (some of which are significant or beyond
our control) and assumptions that could cause actual results to
differ materially from our historical experience and our present
expectations or projections. You should carefully consider the
foregoing factors and the other risks and uncertainties that affect
the Company's business, including those described in the Company's
annual reports, relevant reports and other documents published from
time to time by the Company or filed by the Company with the SEC.
We wish to caution you not to place undue reliance on any
forward-looking statements, which speak only as of the date hereof.
We undertake no obligation to publicly update or revise any of our
forward-looking statements after the date they are made, whether as
a result of new information, future events or otherwise, except to
the extent required by law.
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