Motif Bio plc today announced unaudited financial results for the half year ended June 30, 2018 and reported on its progress year to date.
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specializing in developing novel antibiotics, today announced unaudited financial results for the half year ended June 30, 2018 and reported on its progress year to date.
Graham Lumsden, CEO of Motif Bio, said: “We made tremendous progress during the first half of 2018, including completing the submission of an NDA with the U.S. FDA for iclaprim in acute bacterial skin and skin structure infections, which was accepted for review in August with confirmation of a Priority Review from FDA resulting in a PDUFA date of February 13, 2019. We are continuing to build on our achievements and are working to increase awareness and understanding of Motif Bio and iclaprim with potential commercialization partners, the medical community and investors. As partnering discussions progress, we continue to evaluate ways to build a team of Medical Science Liaisons, Key Account Managers and Professional Representatives to be able to deliver iclaprim to patients in an effective and efficient manner. Our primary focus is ensuring a successful launch and commercialization in the first half of 2019, assuming that iclaprim is approved for marketing by the FDA.”
Corporate and Development Highlights – 2018 Year to Date:
- New Drug Application (“NDA”) submitted to the U.S. Food & Drug Administration (“FDA”) for investigational drug candidate iclaprim for treatment of patients with acute bacterial skin and skin structure infections (“ABSSSI”). The NDA was accepted for filing by FDA and granted priority review. The FDA has set a target action date under the Prescription Drug User Fee Act (“PDUFA”) of February 13, 2019.
- Notice of Allowance received from the United States Patent and Trademark Office for United States Patent Application Nos. 15/586,021 and 15/586,815 for the use of iclaprim to treat patients with bacterial infections. The two method of use patents will expire in November 2037.
- New iclaprim data presented at key infectious disease conferences, including American Society of Microbiology (ASM) Microbe in Atlanta, GA, USA and 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Madrid, Spain.
- Results of REVIVE-2 Phase 3 trial in ABSSSI published in peer-reviewed journal, Antimicrobial Agents and Chemotherapy.
- Our operational team was strengthened by the appointment of Stephanie Noviello, MD, MPH, as Vice President, Clinical Development.
- Award received from the Cystic Fibrosis Foundation to fund important in vitrotesting that will help to advance the development of iclaprim for the treatment of lung infections in patients with cystic fibrosis.
Financial Highlights
- Net loss for the six months ended June 30, 2018 and 2017 was US$7.8 million and US$29.7 million, respectively.
- General and administrative expenses decreased by US$0.5 million to US$4.1 million in the six months ended June 30, 2018 from US$4.6 million in the six months ended June 30, 2017. This decrease was primarily attributable to a US$0.6 million reduction in stock-based compensation and a US$0.2 million reduction in legal, investor relations and other professional services. This decrease was partially offset by a US$0.3 million increase in employee compensation.
- Research and development expenses decreased by US$16.7 million to US$6.9 million in the six months ended June 30, 2018 from US$23.6 million in the six months ended June 30, 2017. This decrease was primarily attributable to a US$20.6 million reduction in expense for our REVIVE Phase 3 clinical trial program, which was completed in 2017.
- On May 17, 2018, we raised US$12.7 million of net proceeds, after deducting US$0.7 million of issuance costs, from a placement of 32,258,064 new ordinary shares at 31 pence per share to both existing and new investors.
- At June 30, 2018 and December 31, 2017, we had cash and cash equivalents of US$19.8 million and US$22.7 million, respectively.
For further information, please contact:
Motif Bio plc
Graham Lumsden (Chief Executive 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
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
Solebury Trout (U.S. IR)
+ 1 (646) 378-2963
Meggie Purcell
Russo Partners (U.S. PR)
+1 (858) 717-2310 or +1 (212) 845 4272
David Schull
david.schull@russopartnersllc.
Travis Kruse, Ph.D.
travis.kruse@russopartnersllc.
Notes to Editors:
About Motif Bio
Motif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage biopharmaceutical company focused on developing novel antibiotics for hospitalised patients and 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. Following positive results from two Phase 3 trials (REVIVE-1 and REVIVE-2), a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is now under review, with a PDUFA date of February 13, 2019. 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 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 building a patent estate to provide additional protection for iclaprim. On August 8, 2018 the Company announced that it had received a Notice of Allowance from the United States Patent and Trademark Office for United States Patent Application Nos. 15/586,021 and 15/586,815. The claims relate to the use of iclaprim to treat patients with bacterial infections, including but not limited to acute bacterial skin and skin structure infections, hospital-acquired bacterial pneumonia and Staphylococcus aureus lung infections in patients with cystic fibrosis. The two method of use patents will expire in November 2037. Other patent applications have been and are expected to be filed that are designed to protect our proprietary technologies, including processes for manufacturing the iclaprim active pharmaceutical ingredient and therapeutic formulations, their use in pharmaceutical preparations and methods of treating disease with iclaprim.
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 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, and (x) 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 10, 2018, 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.
