Motif Bio Reports Fiscal Year 2018 Results
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 Officefor 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 Goldappointed 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 Bioreported a net loss of $14.0 millionor $(.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 millionfor 2018, compared to $29.5 millionfor 2017. This decrease was primarily attributable to a $22.1 millionreduction in expense for the iclaprim Phase III clinical trial program, which was completed in 2017. This decrease was partially offset by a $3.6 millionincrease 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 millionfor 2018, compared to $8.5 millionin 2017. This decrease was primarily attributable to a $0.4 millionreduction 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 millionreduction in legal, investor relations and other professional fees. This decrease was partially offset by a $0.7 millionincrease in employee cash compensation.
$12.7 millionof net proceeds through the issuance of ordinary shares London’s AIM market.
- Cash and cash equivalents of approximately
$12.3 millionas 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
FDAregarding NDA for iclaprim; Motif’s request to meet with the FDAto discuss the points raised in the CRL was granted and a meeting is scheduled for May 3, 2019.
Bruce Williamsappointed interim Chairman following resignation of Richard Morganfrom Board of Directors.
$3.3 millionof 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 email@example.com|
|Graham Lumsden (Chief Executive Officer)|
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|Dr Christopher Golden|
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Note to Editors
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
Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the
This 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
Consolidated statements of comprehensive loss
For 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 $|
|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|
|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|
|Weighted average number of ordinary shares|
Consolidated statements of financial position
As at December 31, 2018 and 2017
|(in thousands)||December 31, 2018||December 31, 2017|
|US $||US $|
|Other non-current assets||18||23|
|Total non-current assets||6,214||6,219|
|Prepaid expenses and other receivables||231||318|
|Cash and cash equivalents||12,279||22,651|
|Total current assets||12,510||22,969|
|Term loan, net of current portion||10,131||14,057|
|Other non-current liabilities||196||23|
|Total non-current liabilities||10,327||14,080|
|Trade payables and accrued liabilities||7,207||10,890|
|Term loan, current portion||4,327||—|
|Payable on completion of clinical trial||—||500|
|Total current liabilities||17,323||24,016|
|Net assets (liabilities)||(8,926||)||(8,908||)|
|Group reorganization reserve||9,938||9,938|