StockMarketWire.com - Motif Bio reported a net loss for the six months ended 30 June 2017 and 2016 was $29.7m and $14.2m, respectively.

BUSINESS UPDATE:

- On April 18 2017, we announced positive top-line results from REVIVE-1, a global Phase 3 clinical trial of our investigational drug candidate iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI). Iclaprim achieved the primary endpoint of non-inferiority (10% margin) compared to vancomycin at the early time point, 48 to 72 hours after start of study drug administration in the intent-to-treat patient population. Given its differentiated mechanism, potency, spectrum, safety and efficacy, iclaprim, if approved, could provide a valuable new antibiotic treatment option. Iclaprim was well tolerated in the study, with most adverse events categorized as mild

- Our operational team and Board of Directors were strengthened by the appointments of Robert Dickey IV as Chief Financial Officer on January 17, 2017 and Dr. Craig T Albanese, Chief Operating Officer of the Morgan Stanley Children's Hospital, as a non-executive director on May 5, 2017.

- Three appointments were made to our Clinical Advisory Board: Dr. Thomas Lodise, Dr. Thomas Holland and Dr. William O'Riordan. These experts participated in our recent Investor and Analyst Event, providing insight on ABSSSI, current treatments and iclaprim's potential role in treating this serious skin infection

After the period end, we continued to make strong operational and strategic progress.

- On August 9, 2017, we announced that the last patient had completed the treatment phase in REVIVE-2, the second Phase 3 clinical trial investigating the safety and efficacy of iclaprim in patients with ABSSSI.

- On September 15, 2017, we announced that the US Food and Drug Administration (FDA) granted Orphan Drug Designation to iclaprim for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis

- This designation grants special status to a drug or biologic under development to treat a rare disease or condition and qualifies the sponsor of the product for various development incentives, including tax credits for qualified clinical testing, waiver of user fees and potentially up to seven years of market exclusivity for the given indication, if approved

- Top-line results from REVIVE-2, which uses an identical protocol to REVIVE-1 but has different trial centres, are expected in the fourth quarter of 2017. We believe that the successful completion of the REVIVE-1 and REVIVE-2 Phase 3 trials satisfy both FDA and European Medicines Agency (EMA) requirements for regulatory submission for an IV formulation of iclaprim in the treatment of ABSSSI

- We continue to anticipate submission of a New Drug Application (NDA) for iclaprim for the treatment of ABSSSI in the United States in the first quarter of 2018 and a Marketing Authorisation Application (MAA) for iclaprim for the treatment of ABSSSI in Europe in the first half of 2018

FINANCIAL HIGHLIGHTS:

- On June 23 2017, we raised $23.7m of net proceeds, after deducting $1.7m of issuance costs, from a placement in the United Kingdom of 66,666,667 new ordinary shares at 30p per share

- At June 30 2017 and December 31 2016, we had cash and cash equivalents of $29.5m and $21.8m, respectively. At September 22 2017, our cash and cash equivalents were $18.1m

- Our strategy is focused on gaining approval for and commercialising iclaprim for ABSSSI and the continued development of iclaprim for additional indications to potentially broaden its use as a safe and effective antibiotic

- In this regard, we have completed the necessary steps to initiate a Phase 3 clinical trial of iclaprim for the treatment of hospital-acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia (VABP). However, we will be required to raise additional capital within the next year to commercialise and further develop iclaprim and to continue to fund operations




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