Mereo BioPharma Announces Interim Financial Results for the Six Months Ended June 30, 2020 and Provides Corporate Update
September 29 2020 - 7:00AM
Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), “Mereo” or “the
Company”, a clinical stage biopharmaceutical company focused on
oncology and rare diseases, today announces unaudited interim
financial results for the six months ended June 30, 2020 and
provides a corporate update.
Denise Scots-Knight, Chief Executive of Mereo,
said: “Following the closing of our $70 million financing in the
first half of 2020 we have focussed on executing our strategy,
advancing etigilimab (“Anti-TIGIT”) for the treatment of solid
tumors alongside developing our rare disease portfolio. We remain
on track to initiate a Phase 1b/2 study of etigilimab (Anti-TIGIT)
in combination with an anti-PD-1 in a range of solid tumor types in
Q4 2020. Our rare disease portfolio includes setrusumab for
osteogenesis imperfecta which we plan to partner prior to the
initiation of a pivotal Phase 3 study, and alvelestat which is
being investigated in an ongoing Phase 2 proof-of-concept study for
alpha-1 anti-trypsin deficiency. We were also pleased to have
recently announced the initiation of a Phase 1b/2
placebo-controlled study of alvelestat in COVID-19 infected
patients following the scientific publications demonstrating the
involvement of neutrophil elastase in COVID-19 infection pathways.
We also continue to advance other discussions with potential
partners to optimize the value of our broader product
portfolio.”
Recent Highlights and Upcoming
Milestones
Etigilimab (Anti-TIGIT) for Solid
Tumors
- On track to initiate a Phase 1b/2
study of etigilimab in combination with an anti-PD-1 in a range of
solid tumor types in Q4 2020.
Setrusumab for
Osteogenesis Imperfecta (OI)
- Receipt of FDA Rare Pediatric Disease
Designation on September 23, 2020.
- Following regulatory discussions in 1H
2020, both the FDA and EMA have agreed on the principles of a
design of a single Phase 3 pediatric pivotal study in OI.
- Intend to partner setrusumab prior to
conducting a pivotal trial of setrusumab in children with severe
OI. Partnering discussions are well underway with a range of
potential structures including options for Mereo to retain
commercial rights in certain regions.
Alvelestat for
Severe Alpha-1 Antitrypsin Deficiency
(AATD)
- Topline data from an ongoing Phase 2
proof of concept study remains on track for 2H 2021.
- Announced the initiation of a Phase
1b/2 placebo-controlled clinical trial to evaluate the safety and
efficacy of alvelestat in hospitalized, adult patients with
moderate to severe COVID-19 respiratory disease.
- Investigator-sponsored studies
underway in AATD and in the orphan disease, bronchiolitis
obliterans syndrome (BOS).
Partnering Discussions Continue for
Portfolio of Other Clinical-Stage
Programs
- Leflutrozole for hypogonadotropic
hypogonadism (HH) º Partnering discussions
continuing based on development in male infertility.
- Acumapimod for Acute Exacerbations of
Chronic Obstructive Pulmonary Disease (AECOPD)
º Discussions continuing on separate financing for the Phase
3 study agreed with the FDA and EMA.
Corporate
- Appointment of Dr. Brian Schwartz and
Dr. Jeremy Bender as Non-Executive Directors and departure of Mr
Paul Blackburn as Non-Executive Director effective October 1,
2020
- Dr. John Lewicki appointed as Chief
Scientific Officer and Dr. Ann Kapoun appointed as Head
Translational R&D in July 2020.
Financial Highlights
- Cash resources of £56.8 million as at
June 30, 2020 (June 30, 2019 £36.1 million).
- £11.8 million raised in equity and
debt in Q1 2020.
- Additional $70 million (£56 million)
raised in PIPE in Q2 2020.
- Cash runway to early 2022.
Conference Call InformationMereo
will host a live conference call and webcast today at 8:00 a.m. EDT
/ 1:00 p.m. BST to discuss the Company’s financial results and
provide a corporate update.
Dial-in numbers: (866) 688-2942 (U.S.) or +1 (561)
569-9224 (U.K./International)
Conference ID number: 9572439
A live and archived webcast may be accessed by
visiting the Investors sections of the Company’s website at
https://www.mereobiopharma.com/investors/results-reports-and-presentations/.
The archived webcast will remain available on the Company's website
following the live call.
About Mereo
BioPharmaMereo BioPharma is a
biopharmaceutical company focused on the development and
commercialization of innovative therapeutics that aim to improve
outcomes for oncology and rare diseases. Mereo's lead oncology
product candidate, etigilimab ("Anti-TIGIT"), has completed a Phase
1a dose escalation clinical trial in patients with advanced solid
tumors and has been evaluated in a Phase 1b study in combination
with nivolumab in select tumor types. Mereo's rare disease product
portfolio consists of setrusumab, which has completed a Phase 2b
dose-ranging study in adults with osteogenesis imperfecta ("OI"),
as well as alvelestat, which is being investigated in a Phase 2
proof-of-concept clinical trial in patients with alpha-1
antitrypsin deficiency ("AATD") and in a Phase 1b/2 clinical trial
in COVID-19 respiratory disease.
Additional Information The
person responsible for arranging the release of this information on
behalf of the Company is Charles Sermon, General Counsel.
Forward-Looking StatementsThis
Announcement contains "forward-looking statements." All statements
other than statements of historical fact contained in this
Announcement are forward-looking statements within the meaning of
Section 27A of the United States Securities Act of 1933, as amended
and Section 21E of the United States Securities Exchange Act of
1934, as amended. 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 the
Company's current expectations, beliefs and assumptions concerning
future developments and business conditions and their potential
effect on the Company. While management believes that these
forward-looking statements are reasonable as and when made, there
can be no assurance that future developments affecting the Company
will be those that it anticipates.
All of the Company's forward-looking statements
involve known and unknown risks and uncertainties (some of which
are significant or beyond its control) and assumptions that could
cause actual results to differ materially from the Company's
historical experience and its present expectations or projections.
The foregoing factors and the other risks and uncertainties that
affect the Company's business, including those described in its
Annual Report on Form 20-F, Reports on Form 6-K and other documents
filed from time to time by the Company with the United States
Securities and Exchange Commission. The Company wishes to caution
you not to place undue reliance on any forward-looking statements,
which speak only as of the date hereof. The Company undertakes 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.
Mereo BioPharma
Contacts:
Mereo |
+44 (0)333 023 7300 |
Denise Scots-Knight, Chief Executive Officer |
|
|
|
N+1 Singer (Nominated Adviser and Broker
to Mereo) |
+44 (0)20 7496 3081 |
Phil Davies |
|
Will Goode |
|
|
|
Burns McClellan (US Investor Relations Adviser
to Mereo) |
+1 212 213 0006 |
Lisa Burns |
|
Steve Klass |
|
|
|
FTI Consulting (UK Public Relations Adviser
to Mereo) |
+44 (0)20 3727 1000 |
Simon Conway |
|
Ciara Martin |
|
|
|
Investors |
investors@mereobiopharma.com |
Consolidated statement of comprehensive lossfor the
six months ended June 30, 2020
|
Notes |
Six months endedJune 30,
2020Unaudited£’000 |
|
Six months endedJune 30, 2019Unaudited£’000 |
|
Year endedDecember 31, 2019Audited£’000 |
|
Research and
development expenses |
(8,479 |
) |
(11,918 |
) |
(23,608 |
) |
Administrative expenses |
(8,212 |
) |
(6,918 |
) |
(15,909 |
) |
Operating loss |
|
(16,691 |
) |
(18,836 |
) |
(39,517 |
) |
Net income
recognised on acquisition of subsidiary |
|
— |
|
1,035 |
|
1,035 |
|
Finance
income |
|
39 |
|
137 |
|
377 |
|
Finance
charge |
3 |
(97,628 |
) |
(998 |
) |
(3,496 |
) |
Loss on disposal
of intangible assets |
4 |
(11,302 |
) |
— |
|
— |
|
Net foreign
exchange (loss)/gain |
|
(519 |
) |
(20 |
) |
483 |
|
Loss before tax |
|
(126,101 |
) |
(18,682 |
) |
(41,118 |
) |
Taxation |
|
1,482 |
|
2,459 |
|
6,274 |
|
Loss for the period, attributable to equity holders of the
parent |
(124,619 |
) |
(16,224 |
) |
(34,844 |
) |
Basic and diluted loss per share for the
period |
|
(1.05 |
) |
(0.22 |
) |
(0.39 |
) |
|
|
|
|
|
Other comprehensive income / (loss)Items that may
be subsequently reclassified to the income statement |
Fair value changes on investments held at fair value through
OCI |
3 |
|
88 |
|
— |
|
Currency translation of foreign operations |
|
1,324 |
|
711 |
|
(499 |
) |
|
|
|
|
|
Total comprehensive loss for the period, attributable to
equity holders of the parent |
|
(123,292 |
) |
(15,425 |
) |
(35,343 |
) |
|
|
|
|
|
|
|
|
|
|
Consolidated balance sheetas at June 30, 2020
|
Notes |
June 30,
2020Unaudited£’000 |
|
June 30, 2019Unaudited£’000 |
|
December 31, 2019Audited£’000 |
|
Assets |
|
|
|
|
Non-current
assets |
|
|
|
|
Property, plant and
equipment |
|
11,225 |
|
13,100 |
|
11,558 |
|
Intangible assets |
4 |
31,876 |
|
45,157 |
|
44,456 |
|
|
|
43,101 |
|
58,257 |
|
56,014 |
|
Current assets |
|
|
|
|
Prepayments |
|
1,400 |
|
3,068 |
|
2,111 |
|
R&D tax credits |
|
6,624 |
|
7,745 |
|
10,426 |
|
Other taxes recoverable |
|
— |
|
— |
|
979 |
|
Other receivables |
|
1,836 |
|
1,953 |
|
572 |
|
Short-term investments |
|
— |
|
7,828 |
|
— |
|
Cash and short-term
deposits |
|
56,821 |
|
28,290 |
|
16,347 |
|
|
|
66,681 |
|
48,884 |
|
30,435 |
|
Total assets |
|
109,782 |
|
107,141 |
|
86,449 |
|
Equity and liabilities |
|
|
|
|
Equity |
|
|
|
|
Issued capital |
7 |
1,016 |
|
294 |
|
294 |
|
Share premium |
7 |
161,785 |
|
121,684 |
|
121,684 |
|
Other capital reserves |
7 |
127,727 |
|
58,004 |
|
59,147 |
|
Employee Benefit Trust
shares |
7 |
(1,305 |
) |
(1,305 |
) |
(1,305 |
) |
Other reserves |
7 |
4,875 |
|
7,000 |
|
7,000 |
|
Accumulated losses |
7 |
(270,681 |
) |
(127,357 |
) |
(146,065 |
) |
Translation reserve |
7 |
825 |
|
711 |
|
(499 |
) |
Total equity |
|
24,242 |
|
59,031 |
|
40,256 |
|
Non-current liabilities |
|
|
|
|
Provisions |
8 |
1,698 |
|
1,927 |
|
1,449 |
|
Interest-bearing loans and
borrowings |
6 |
14,506 |
|
11,721 |
|
5,373 |
|
Other liabilities |
|
44 |
|
34 |
|
44 |
|
Warrant liability |
9 |
35,757 |
|
225 |
|
131 |
|
Lease
liability |
|
11,167 |
|
13,139 |
|
9,318 |
|
|
|
63,172 |
|
27,046 |
|
16,315 |
|
Current liabilities |
|
|
|
|
Trade and other payables |
|
5,489 |
|
6,758 |
|
6,352 |
|
Accruals |
|
2,701 |
|
5,961 |
|
5,138 |
|
Provisions |
8 |
31 |
|
334 |
|
309 |
|
Interest-bearing loans and
borrowings |
6 |
13,254 |
|
8,011 |
|
15,139 |
|
Contingent consideration
liability |
|
— |
|
— |
|
354 |
|
Lease
liability |
|
893 |
|
— |
|
2,586 |
|
|
|
22,298 |
|
21,064 |
|
29,878 |
|
Total liabilities |
|
85,540 |
|
48,110 |
|
46,193 |
|
Total equity and liabilities |
|
109,782 |
|
107,141 |
|
86,449 |
|
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