Motif Bio Reports Year-End 2016 Financial Results
(Thomson Reuters ONE) -
NEW YORK, May 01, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (NASDAQ:MTFB)
(AIM:MTFB.LN), a clinical stage biopharmaceutical company specialising in
developing novel antibiotics, today announced financial results for the year
ended December 31, 2016.
"Motif Bio made significant progress in 2016 towards our goal of bringing our
novel antibiotic candidate, iclaprim, to patients with serious and life-
threatening infections. The announcement of positive Phase 3 topline results for
iclaprim in REVIVE-1 was a major achievement for Motif Bio and we expect to
announce the topline data from REVIVE-2, the second Phase 3 trial, in the second
half of 2017," commented Graham Lumsden, CEO of Motif Bio plc.
Recent Corporate Developments
* Announced positive topline results for iclaprim in the REVIVE-1 Phase 3
study of acute bacterial skin and skin structure infections (ABSSSI)
* Data from REVIVE-2, which uses an identical protocol to REVIVE-1 but has
different trial centres, has more than 80% of the total patients enrolled,
and data is expected in the second half of 2017
* Achieved a NASDAQ listing
* Closed a U.S. initial public offering and a concurrent European placement
with aggregate net proceeds of $21.5 million, which brought the total raised
by the Company to approximately $65 million
* Appointed Robert Dickey IV as Chief Financial Officer
* Presented two posters at ID Week 2016. The first showed new data
demonstrating that iclaprim is highly potent in vitro against bacterial
strains associated with clinical Hospital Associated Bacterial Pneumonia
(HABP) and Skin and Skin Structure Infections (SSSI) clinical isolates. The
second poster described the potential benefits of an optimized 80mg fixed
dose of iclaprim administered intravenously over 120 minutes, that is being
used in the REVIVE Phase 3 clinical trials. Improvement by approximately
30% in the PK/PD parameters associated with efficacy, AUC/MIC and t/MIC, was
seen compared to the previously studied weight based dose of 0.8 mg/kg.
* Completed preparations for INSPIRE, a Phase 3 trial designed to study the
safety and efficacy of iclaprim in patients with HABP, including ventilator
associated bacterial pneumonia (VABP)
* Completed additional research with clinicians and payers to understand how
iclaprim may be able to address the unmet need in hospitalised ABSSSI
patients with renal impairment with/without diabetes
Full Year 2016 Financial Results
* For the full year, Motif Bio reported a net loss of $40.3 million, or
$(0.35) per share (basic and diluted) compared to a net loss of $8.5
million, or $(0.14) per share (basic and diluted) during the same period in
2015.
* Research and development (R&D) costs for 2016 were $34.8 million compared to
$4.7 million during 2015. Higher R&D costs in 2016 were primarily
attributable to the commencement of iclaprim clinical development. Clinical
development expenses are a significant component of our research and
development expenses and product candidates in later stage development
generally have higher costs.
* General and administrative expenses for 2016 were $4.9 million compared to
$3.6 million during 2015. The increase is primarily due to the costs
associated with the filing of a registration statement relating to the
initial public offering in the U.S.; costs associated with being a public
company in both the United Kingdom and the U.S.; and increases in the costs
of outside professional services.
* Cash and cash equivalents were $21.8 million as of December 31, 2016.
* As of December 31, 2016, the Company had 195.7 million ordinary shares
outstanding.
Motif Bio has filed its U.S. Annual Report on Form 20-F for the year ended
December 31, 2016 with the US Securities and Exchange Commission ("SEC"). The
Form 20-F is available to download, either from the Investors section of the
Company website at www.motifbio.com, the SEC website at www.sec.gov or from the
link below.
Click here to download the Form 20-F
About iclaprim
Iclaprim is a potential novel antibiotic, designed to be effective against
bacteria that have developed resistance to other antibiotics, including
trimethoprim. Iclaprim exhibits potent in vitro activity against Gram-positive
clinical isolates of many genera of staphylococci, including methicillin
sensitive Staphylococcus aureus (MSSA) and methicillin resistant Staphylococcus
aureus (MRSA). The MIC90 of iclaprim was lower than most comparators including
vancomycin and linezolid, standard of care therapies used in serious and life-
threatening Gram-positive hospital infections. To date, iclaprim has been
studied in over 1,000 patients and healthy volunteers. Iclaprim is administered
intravenously at a fixed dose, with no dosage adjustment required in patients
with renal impairment, or in obese patients. This may help reduce overall
hospital treatment costs, especially in renally impaired patients.
About Motif Bio plc www.motifbio.com
Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research
and development of novel antibiotics designed to be effective against serious
and life-threatening infections in hospitalised patients caused by multi-drug
resistant bacteria. Our lead product candidate, iclaprim, is being developed for
the treatment of acute bacterial skin and skin structure infections (ABSSSI) and
hospital acquired bacterial pneumonia (HABP), including ventilator associated
bacterial pneumonia (VABP), infections often caused by MRSA (methicillin
resistant Staphylococcus aureus). Having completed the REVIVE-1 trial, patients
are currently being enrolled and dosed in a second global Phase 3 clinical trial
(REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of
ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017.
Forward-Looking Statements
This press release contains forward-looking statements. Words such as "expect,"
"believe," "intend," "plan," "continue," "may," "will," "anticipate," and
similar expressions are intended to identify forward-looking statements.
Forward-looking statements involve known and unknown risks, uncertainties and
other important factors that may cause Motif Bio's actual results, performance
or achievements to be materially different from any future results, performance
or achievements expressed or implied by the forward-looking statements. Motif
Bio believes that these factors include, but are not limited to, (i) the timing,
progress and the results of clinical trials for Motif Bio's product candidates,
(ii) the timing, scope or likelihood of regulatory filings and approvals for
Motif Bio's product candidates, (iii) Motif Bio's ability to successfully
commercialize its product candidates, (iv) Motif Bio's ability to effectively
market any product candidates that receive regulatory approval, (v) Motif Bio's
commercialisation, marketing and manufacturing capabilities and strategy, (vi)
Motif Bio's expectation regarding the safety and efficacy of its product
candidates, (vii) the potential clinical utility and benefits of Motif Bio's
product candidates, (viii) Motif Bio's ability to advance its product candidates
through various stages of development, especially through pivotal safety and
efficacy trials, and (ix) Motif Bio's estimates regarding the potential market
opportunity for its product candidates, and (x) the factors discussed in the
section entitled "Risk Factors" in Motif Bio plc's Annual Report on Form 20-F
filed with the SEC on May 1, 2017, which is available on the SEC's web site,
www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any
forward-looking statements.
"This announcement contains inside information for the purposes of Article 7 of
the Market Abuse Regulation (EU) No 596/2014 and has been released by Robert
Dickey IV, Chief Financial Officer, on behalf of the Company."
For further information please contact:
Motif Bio plc info(at)motifbio.com
Graham Lumsden (Chief Executive
Officer)
Robert Dickey IV (Chief Financial
Officer)
Peel Hunt LLP (NOMAD & BROKER) + 44 (0)20 7418 8900
Dr Christopher Golden
Oliver Jackson
Northland Capital Partners Limited
(BROKER) +44 (0)203 861 6625
Patrick Claridge/ David Hignell
John Howes/ Rob Rees (Broking)
Westwicke Partners 001 415-513-1284
Patricia L. Bank patti.bank(at)westwicke.com
Walbrook PR Ltd. (FINANCIAL PR & +44 (0) 20 7933 8780
IR) or motifbio(at)walbrookpr.com
Paul McManus Mob: +44 (0)7980 541 893
Mike Wort Mob: +44 (0)7900 608 002
MC Services AG (EUROPEAN IR) +49 (0)89 210 2280
Motif Bio plc Selected Financial Data
Year Year Year
ended ended ended
12/31/2016 12/31/2015 12/31/2014
US $ US $ US $
------------------- ------------------------------------
Continuing
operations
General and
administrative
expenses (4,912,150 ) (3,577,180 ) (1,096,116 )
Research and
development expenses (34,794,815 ) (4,680,940 ) -
Gains on settlement
of contract disputes 83,320 5,027 360,060
------------------- ------------------------------------
Operating
loss (39,623,645 ) (8,253,093 ) (736,056 )
Interest
income 69,754 15,028 78
Interest
expense (383,259 ) (268,216 ) (449,036 )
Net foreign
exchange losses (250,926 ) (9,644 ) -
Loss from
revaluation of
derivative
liabilities (135,939 ) - -
------------------- ------------------------------------
Loss before
income taxes (40,324,015 ) (8,515,925 ) (1,185,014 )
Income tax (287 ) (774 ) (876 )
------------------- ------------------------------------
Net loss for
the year (40,324,302 ) (8,516,699 ) (1,185,890 )
------------------- ------------------------------------
Total comprehensive
loss for the year (40,324,302 ) (8,516,699 ) (1,185,890 )
------------------- ------------------------------------
Net loss per
share
Basic and diluted
per share * $ (0.35 ) $ (0.14 ) $ (0.03 )
------------------- ------------------------------------
Weighted average
number of
ordinary shares,
basic and diluted 116,558,191 61,225,922 36,726,342
* In accordance with IAS 33 "Earnings per share", shares are not diluted
where the entity has reported a loss for the period.
December 31, 2016 December 31, 2015
US $ US $
--------------------- --------------------
ASSETS
Non-current assets
Intangible assets 6,195,748 6,195,748
--------------------- --------------------
Total non-current assets 6,195,748 6,195,748
--------------------- --------------------
Current assets
Prepaid expenses and other
receivables 401,064 167,657
Cash 21,829,632 28,594,347
--------------------- --------------------
Total current assets 22,230,696 28,762,004
--------------------- --------------------
Total assets 28,426,444 34,957,752
--------------------- --------------------
LIABILITIES
Non-current liabilities
Payable on completion of clinical
trial - 500,000
--------------------- --------------------
Total non-current
liabilities - 500,000
--------------------- --------------------
Current liabilities
Trade and other payables 12,319,117 987,083
Other interest-bearing loans and
borrowings - 3,747,961
Derivative liability 5,798,058 -
Payable on completion of clinical
trial 500,000 -
--------------------- --------------------
Total current
liabilities 18,617,175 4,735,044
--------------------- --------------------
Total liabilities 18,617,175 5,235,044
--------------------- --------------------
Net assets 9,809,269 29,722,708
--------------------- --------------------
EQUITY
Share capital 2,728,199 1,645,291
Share premium 57,348,694 38,534,280
Group reorganization
reserve 9,938,362 9,938,362
Accumulated deficit (60,205,986 ) (20,395,225 )
--------------------- --------------------
Total equity 9,809,269 29,722,708
--------------------- --------------------
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Motif BioSciences Inc. via GlobeNewswire
Datum: 01.05.2017 - 22:30 Uhr
Sprache: Deutsch
News-ID 539496
Anzahl Zeichen: 17503
contact information:
Town:
New York
Kategorie:
Business News
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