NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART DIRECTLY OR INDIRECTLY IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION
This announcement contains inside information
Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announces financial results for the second quarter and half-year ended June 30, 2016.
- On March 2, 2016 we announced the dosing of the first patient in our two REVIVE (Randomized Evaluation IntraVenous Iclaprim Vancomycin trEatment) Phase 3 clinical trials in Acute Bacterial Skin and Skin Structure Infections (ABSSSI). We are enrolling and dosing patients in two global Phase 3 clinical trials with an intravenous (IV) formulation of iclaprim, for the treatment of ABSSSI. Data from the two trials are expected in the second half of 2017.
- In March 2016, we announced that we had appointed The Fulford Group Ltd to assist Motif Bio in developing and implementing strategies to commercialise iclaprim in territories outside of the United States.
- We plan to complete preparations for our INSPIRE (Iclaprim for NoSocomial PneumonIa gRam- positive pathogEns) Phase 3 clinical trial with iclaprim in patients with Hospital Acquired Bacterial Pneumonia (HABP), including patients with Ventilator Associated Bacterial Pneumonia (VABP), by the end of 2016.
- In addition to our clinical programmes, we have a preclinical development programme underway to identify a formulation of iclaprim suitable for adolescent and pediatric patients.
- We are also developing IV and oral formulations of MTF-101, a diaminopyrimidine that may be suitable for testing in clinical trials to demonstrate safety and efficacy in patients with osteomyelitis and patients with prosthetic joint infections.
- At June 30, 2016 and December 31, 2015, we had cash and cash equivalents of approximately US$19.5 million and US$28.6 million, respectively.
- Net cash used in operating activities was US$8.9 million in the six months ended June 30, 2016, which reflects the continuation of the clinical development of iclaprim. Net cash used in operating activities was US$1.2 million for the six months ended June 30, 2015, reflecting the commencement of clinical development of iclaprim.
- General and administrative expenses increased by US$0.8 million, to US$1.9 million, in the six months ended June 30, 2016 from US$ 1.1 million in the six months ended June 30, 2015. This increase was primarily attributable to: (i) an increase in personnel related expenses; (ii) the costs associated with being a public company in the United Kingdom; and (iii) increases in the costs of outside professional services, including commercial evaluation and strategy services, investor relations and other consulting services.
- Research and development expenses increased by US$11.4 million to US$12.0 million in the six months ended June 30, 2016 from US$0.6 million in six months ended June 30, 2015. This increase was primarily attributable to the commencement of iclaprim clinical development. For the six months ended June 30, 2016, US$10.1 million was spent in relation to contract research organization expenses, US$1.0 million in relation to clinical operations and US$0.9 million in relation to chemistry and manufacturing development and other non-clinical development.
Post period highlights
- Motif Bio has deferred pricing of its proposed public offering of American Depositary Shares (“ADSs”) and listing of ADSs on the NASDAQ Global Market. The Company remains in registration with the Securities and Exchange Commission and is continuing to engage with investors.
“We are very pleased that our lead product candidate, iclaprim, is now in the final stage of development following the dosing of the first patient in March of this year in our two REVIVE Phase 3 clinical trials in ABSSSI. This is a significant milestone for the company and we expect the data read-out from these two trials in the second half of 2017. We are encouraged to see that patient enrollment to date is ahead of our projections,” commented Dr. Graham Lumsden, Motif Bio’s Chief Executive Officer. “We believe that iclaprim, a novel antibiotic with an under-utilized mechanism of action, if approved, could offer advantages compared to the current standard of care for high-risk, seriously ill patients hospitalised with ABSSSI and who also have renal impairment or diabetes,” added Dr. Lumsden.
A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy these securities be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Motif Bio plc
Graham Lumsden, Chief Executive Officer
Zeus Capital Limited (Nominated Advisor and Broker)
Phil Walker / Giles Balleny
+44 (0) 20 3829 5000
Northland Capital Partners Limited (Broker)
Patrick Claridge / David Hignell
John Howes / Rob Rees (Broking)
+44 (0) 207 382 1100
Walbrook PR Ltd. (Public and Investor Relations)
Paul McManus / Mike Wort
Main: +44 (0)20 7933 8780
Paul: +44 (0)7980 541 893
Mike: +44 (0)7900 608 002
MC Services AG (European IR)
+49 (0) 89 210 2280
About Motif Bio
Motif Bio plc 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. The discovery of new antibiotics has not kept pace with the increasing incidence of resistant, difficult-to-treat bacteria. One of the biggest threats of antibiotic resistance is from MRSA (methicillin resistant Staphylococcus aureus), a leading cause of hospital-acquired infections and a growing cause of infections in healthy people in the general community. In 2013, the Centers of Disease Control (CDC) reported that at least two million people became infected with antibiotic-resistant bacteria and at least 23,000 Americans died as a direct result of these infections. 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 which are often caused by MRSA. We are currently enrolling and dosing patients in two global Phase 3 clinical trials with an IV formulation of iclaprim, for the treatment of ABSSSI.
This news release contains forward-looking statements that reflect Motif Bio’s current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the relevance of Motif Bio’s product candidates, and the clinical benefits, safety profile, and commercial potential of iclaprim. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of Motif Bio’s clinical development strategies, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of iclaprim and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in Motif Bio can be found in Motif Bio’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Motif Bio undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.