Motif Bio Reports Fiscal Year 2018 Results
April 15 2019 - 2:00AM
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced financial results for the year ended
December 31, 2018.
Dr. Graham Lumsden, Chief Executive Officer,
said: “Motif Bio had an incredibly productive year in 2018,
including submitting a New Drug Application to the U.S. FDA for
iclaprim for the treatment of patients with acute bacterial skin
and skin structure infections. Unfortunately, in February
2019 we unexpectedly received a Complete Response Letter from FDA
notifying Motif that the NDA for iclaprim could not be approved as
submitted. The Agency has asked for additional data to assess the
potential for liver toxicity and we have a confirmed FDA meeting
date of May 3, 2019 to discuss the concerns noted in the Complete
Response Letter. We expect to be joined at the meeting by two
external experts and anticipate a collaborative discussion and
hopefully an acceptable path forward. We believe that iclaprim can
be a valuable option for patients and their providers who are in
need of new antibiotic treatment options.”
Corporate and Development
Highlights
- New Drug Application (NDA) submitted to and accepted for
priority review by U.S. Food & Drug Administration (FDA) for
iclaprim for treatment of patients with acute bacterial skin and
skin structure infections (ABSSSI).
- Notice of Allowance from the United States Patent and Trademark
Office for two patent applications. The claims relate to the
use of iclaprim to treat patients with bacterial infections,
including but not limited to ABSSSI, hospital-acquired bacterial
pneumonia and Staphylococcus aureus lung infections in patients
with cystic fibrosis. The two method of use patents, which
have now issued, will expire in November 2037.
- Results from the Phase III REVIVE-2 trial and pooled efficacy
and safety results from the REVIVE-1 and -2 Phase III trials in
ABSSSI published in peer-reviewed medical journals.
- Data on iclaprim safety and efficacy and potential cost
avoidance data presented at major medical conferences.
- Jonathan Gold appointed interim Chief Financial Officer in
February 2018; Stephanie Noviello, MD, MPH joins as Vice President,
Clinical Development in May 2018.
Full Year 2018 Financial Results
Highlights
- Motif Bio reported a net loss of $14.0 million or $(.05) per
share, basic and $(.07) per share, diluted for 2018, compared to
$44.8 million, or $(0.19) per share, basic and diluted for
2017.
- Research and development expenses decreased to $11.0 million
for 2018, compared to $29.5 million for 2017. This decrease was
primarily attributable to a $22.1 million reduction in expense for
the iclaprim Phase III clinical trial program, which was completed
in 2017. This decrease was partially offset by a $3.6 million
increase in costs relating to regulatory and clinical operating
activities, chemistry manufacturing and control requirements and
other non-clinical development activities.
- General and administrative expenses were $7.6 million for 2018,
compared to $8.5 million in 2017. This decrease was primarily
attributable to a $0.4 million reduction in stock-based
compensation, which was higher in the 2017 period partially due to
a previously disclosed out-of-period correction and a $1.3 million
reduction in legal, investor relations and other professional
fees. This decrease was partially offset by a $0.7 million
increase in employee cash compensation.
- Raised $12.7 million of net proceeds through the issuance of
ordinary shares London’s AIM market.
- Cash and cash equivalents of approximately $12.3 million as of
December 31, 2018.
- 296.7 million ordinary shares outstanding as of December 31,
2018.
Post Period End Highlights
- Received Complete Response Letter (CRL) from FDA regarding NDA
for iclaprim; Motif’s request to meet with the FDA to discuss the
points raised in the CRL was granted and a meeting is scheduled for
May 3, 2019.
- Bruce Williams appointed interim Chairman following resignation
of Richard Morgan from Board of Directors.
- Raised $3.3 million of net proceeds through the issuance of
ordinary shares London’s AIM market.
- 342.5 million ordinary shares outstanding as of April 11,
2019.
Motif Bio will file later today its U.S. Annual
Report on Form 20-F for the year ended December 31, 2018 with the
U.S. Securities and Exchange Commission (SEC). The Form 20-F will
be available to download, either from the Investors section of the
Company website www.motifbio.com or the SEC website at www.sec.gov.
An electronic version of the UK Annual Report and Accounts will be
made available on Motif Bio’s website under “AIM Investors” in due
course and announced when available.
Motif Bio expects to hold its next Annual
General meeting at 1 PM BST on May 22, 2019 at the offices of DLA
Piper UK LLP at 160 Aldersgate Street London EC1A 4HT, United
Kingdom.
| Motif Bio plc |
info@motifbio.com |
| Graham Lumsden (Chief Executive Officer) |
|
| |
+44 (0)20 7418 8900 |
| Peel Hunt LLP (NOMAD & JOINT
BROKER) |
|
| Dr Christopher Golden |
|
| Oliver Jackson |
|
| |
|
| SP ANGEL CORPORATE FINANCE
LLP |
|
| (JOINT BROKER) |
+44 (0)20 3470 0470 |
| David Hignell |
|
| Vadim Alexandre |
|
| Rob Rees |
|
| |
|
| Walbrook PR Ltd. (UK FINANCIAL PR &
IR) |
+44 (0) 20 7933 8780 |
| Paul McManus/Helen Cresswell/Lianne
Cawthorne |
|
| |
|
| MC Services AG (EUROPEAN
IR) |
+49 (0)89 210 2280 |
| Raimund Gabriel |
raimund.gabriel@mc-services.eu |
| |
|
| Russo Partners (U.S. PR) |
+1 (858) 717-2310 or +1 (212) 845 4272 |
| David Schull |
david.schull@russopartnersllc.com |
Note to EditorsMotif Bio plc (AIM/NASDAQ: MTFB)
is a clinical-stage biopharmaceutical company focused on developing
novel antibiotics designed to be effective against serious and
life-threatening infections caused by multi-drug resistant
Gram-positive bacteria, including MRSA. The Company's lead product
candidate is iclaprim. Motif Bio is seeking approval of iclaprim
from the U.S. Food & Drug Administration (FDA) for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI). More than 3.6 million patients with ABSSSI are
hospitalised annually in the U.S. It is estimated that up to 26% of
hospitalized ABSSSI patients have renal impairment.
The Company also has plans to develop iclaprim
for hospital acquired bacterial pneumonia (HABP), including
ventilator associated bacterial pneumonia (VABP), as there is a
high unmet need for new therapies in this indication. A Phase
2 trial in patients with HABP has been successfully completed and a
Phase 3 trial is being planned. Additionally, iclaprim has been
granted orphan drug designation by the FDA for the treatment of
Staphylococcus aureus lung infections in patients with cystic
fibrosis and is in preclinical development for this indication.
Iclaprim has received Qualified Infectious
Disease Product (QIDP) designation from the FDA together with Fast
Track status for the ABSSSI indication. If approved for the ABSSSI
indication as a New Chemical Entity, iclaprim will be eligible for
10 years of market exclusivity in the U.S. from the date of first
approval, under the Generating Antibiotic Incentives Now Act (the
GAIN Act). In Europe, 10 years of market exclusivity is
anticipated. Motif is also building a patent estate to
provide additional protection for iclaprim and has two U.S. method
of use patents issued that will expire in 2037.
Forward-Looking StatementsThis 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 commercialise 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,
(ix) Motif Bio's estimates regarding the potential market
opportunity for its product candidates, (x) Motif Bio's ability to
raise additional capital to sustain its operations and pursue its
strategy and (xi) the factors discussed in the section entitled
"Risk Factors" in Motif Bio's Annual Report on Form 20-F filed with
the SEC on April 15, 2019, which is available on the SEC's web
site, www.sec.gov. Motif Bio undertakes no obligation to update or
revise any forward-looking statements.
Motif Bio plcConsolidated statements of
comprehensive lossFor the years ended
December 31, 2018, 2017 and 2016(in thousands, except
share and per share data)
|
|
|
|
Year ended |
|
Year ended |
|
Year ended |
|
|
|
|
|
December 31, 2018 |
|
December 31, 2017 |
|
December 31, 2016 |
|
|
|
|
|
US $ |
|
US $ |
|
US $ |
|
| |
|
|
|
|
|
|
|
|
| Continuing
operations |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
| General and administrative
expenses |
|
|
(7,635 |
) |
|
(8,542 |
) |
|
(4,912 |
) |
|
| |
|
|
|
|
|
|
|
|
| Research and development
expenses |
|
|
(10,988 |
) |
|
(29,475 |
) |
|
(34,795 |
) |
|
| |
|
|
|
|
|
|
|
|
| Gains on settlement of
contract disputes |
|
|
— |
|
|
— |
|
|
83 |
|
|
| |
|
|
|
|
|
|
|
|
| Operating
loss |
|
|
(18,623 |
) |
|
(38,017 |
) |
|
(39,624 |
) |
|
| |
|
|
|
|
|
|
|
|
| Interest income |
|
|
113 |
|
|
134 |
|
|
70 |
|
|
| |
|
|
|
|
|
|
|
|
| Interest expense |
|
|
(2,160 |
) |
|
(275 |
) |
|
(383 |
) |
|
| |
|
|
|
|
|
|
|
|
| Net foreign exchange gains
(losses) |
|
|
40 |
|
|
(238 |
) |
|
(251 |
) |
|
| |
|
|
|
|
|
|
|
|
| Gain (loss) from
revaluation of derivative liabilities |
|
|
6,654 |
|
|
(6,392 |
) |
|
(136 |
) |
|
| |
|
|
|
|
|
|
|
|
| Loss before income
taxes |
|
|
(13,976 |
) |
|
(44,788 |
) |
|
(40,324 |
) |
|
| |
|
|
|
|
|
|
|
|
| Income tax expense |
|
|
(9 |
) |
|
(22 |
) |
|
— |
|
|
| |
|
|
|
|
|
|
|
|
| Net loss for the
year |
|
|
(13,985 |
) |
|
(44,810 |
) |
|
(40,324 |
) |
|
| |
|
|
|
|
|
|
|
|
| Total
comprehensive loss for the year |
|
|
(13,985 |
) |
|
(44,810 |
) |
|
(40,324 |
) |
|
| |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
| Net loss per
share |
|
|
|
|
|
|
|
|
| Basic |
|
|
|
(0.05 |
) |
|
|
(0.19 |
) |
|
|
(0.35 |
) |
|
| Diluted |
|
|
|
(0.07 |
) |
|
|
(0.19 |
) |
|
|
(0.35 |
) |
|
| Weighted average
number of ordinary shares |
|
|
|
|
|
|
|
|
|
|
|
| Basic |
|
|
284,530,534 |
|
|
231,530,091 |
|
|
116,558,191 |
|
|
| Diluted |
|
|
287,131,688 |
|
|
231,530,091 |
|
|
116,558,191 |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
Motif Bio plcConsolidated statements of
financial positionAs at December 31, 2018 and
2017
| (in thousands) |
|
|
December 31, 2018 |
|
December 31, 2017 |
|
|
|
|
|
US $ |
|
US $ |
|
| |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
| Non-current
assets |
|
|
|
|
|
|
| Intangible assets |
|
|
6,196 |
|
|
6,196 |
|
|
| Other non-current
assets |
|
|
18 |
|
|
23 |
|
|
| Total non-current
assets |
|
|
6,214 |
|
|
6,219 |
|
|
| |
|
|
|
|
|
|
| Current
assets |
|
|
|
|
|
|
| Prepaid expenses and other
receivables |
|
|
231 |
|
|
318 |
|
|
| Cash and cash
equivalents |
|
|
12,279 |
|
|
22,651 |
|
|
| Total current assets |
|
|
12,510 |
|
|
22,969 |
|
|
| |
|
|
|
|
|
|
| Total
assets |
|
|
18,724 |
|
|
29,188 |
|
|
| |
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
| Non-current
liabilities |
|
|
|
|
|
|
| Term loan, net of current
portion |
|
|
10,131 |
|
|
14,057 |
|
|
| Other non-current
liabilities |
|
|
196 |
|
|
23 |
|
|
| Total non-current
liabilities |
|
|
10,327 |
|
|
14,080 |
|
|
| |
|
|
|
|
|
|
| Current
liabilities |
|
|
|
|
|
|
| Trade payables and accrued
liabilities |
|
|
7,207 |
|
|
10,890 |
|
|
| Term loan, current
portion |
|
|
4,327 |
|
|
— |
|
|
| Payable on completion of
clinical trial |
|
|
— |
|
|
500 |
|
|
| Derivative
liabilities |
|
|
5,789 |
|
|
12,626 |
|
|
| Total current
liabilities |
|
|
17,323 |
|
|
24,016 |
|
|
| |
|
|
|
|
|
|
| Total
liabilities |
|
|
27,650 |
|
|
38,096 |
|
|
| |
|
|
|
|
|
|
| Net assets
(liabilities) |
|
|
(8,926 |
) |
|
(8,908 |
) |
|
| |
|
|
|
|
|
|
|
EQUITY |
|
|
|
|
|
|
| Share capital |
|
|
4,032 |
|
|
3,589 |
|
|
| Share premium |
|
|
93,456 |
|
|
80,873 |
|
|
| Group reorganization
reserve |
|
|
9,938 |
|
|
9,938 |
|
|
| Accumulated deficit |
|
|
(116,352 |
) |
|
(103,308 |
) |
|
| |
|
|
|
|
|
|
| Total
deficit |
|
|
(8,926 |
) |
|
(8,908 |
) |
|
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