Proactive Investors - Run By Investors For Investors
Why invest in MTFB?
Motif Bio PLC: DEEP DIVE
OVERVIEW

Motif Bio seeks talks with US drugs regulator

Motif’s lead drug candidate is iclaprim, a next-generation antibiotic for which it was seeking US FDA approval for use in patients with acute bacterial skin and skin structure infections
Motif Bio seeks talks with US drugs regulator
OVERVIEW: MTFB The Big Picture
The Motif drug was developed to treat serious and life-threatening Gram-positive infections

• Motif Bio seeking talks with FDA after recent drug setback 

• US regulator has requested more data on antibiotic iclaprim

• In cash conservation mode after repaying a tranche of a loan

 

What the company does: 

Motif Bio PLC’s (LON:MTFB) (NASDAQ:MTFB) lead drug candidate is iclaprim, a next-generation antibiotic for which it was seeking Food & Drug Administration approval for use in patients with acute bacterial skin and skin structure infections (ABSSSI). On February 14, the American watchdog said it wouldn’t be giving the regulatory green light. Unsurprisingly, the share price dropped sharply.

What next?

Motif is keen “to discuss potential options to address the deficiencies” with the information it had furnished. According to chief executive Graham Lumsden, the team may have to wait between 30-45 days before having the opportunity to do so.

So what’s the problem?

The FDA wants additional data so it can “further evaluate the risk for liver toxicity” before it decides whether or not to grant new drug approval. As one of Motif’s advisers pointed out, this wasn’t a straight ‘no’. So there may still be some hope.

Cash is key

Motif said it will manage its cash aggressively after announcing plans to immediately repay a US$7mln tranche of a loan it has taken out. It also signalled it will have to quickly raise funds after being left with just US$3mln in cash following the payment to Hercules Capital. It still owes US$7.7mln to Hercules.

What now?

“The company is currently assessing the options available to it to raise sufficient capital to provide cash runway to enable it to meet the FDA and discuss options to advance iclaprim towards approval,” Motif told investors on February 18.

iclaprim at a glance

Well-differentiated antibiotic candidate for serious and life-threatening Gram-positive infections in hospitalised patients.

Intended follow-on indications for hospital-acquired bacterial pneumonia (HABP) and staphylococcus lung infections in patients with cystic fibrosis.

View full MTFB profile View Profile

Motif Bio PLC Timeline

Newswire
May 07 2019

Related Articles

1550850611_CancerHeadline.jpg
February 22 2019
Broker Hybridan reckons Sareum is “arguably a bargain target for the relatively large group of biotech and pharma companies interested in TYK2 and the wider JAK inhibitor space”
lung x-ray
May 07 2019
The company has been developing a treatment for chronic lung disease in-house and has partnered with an Australian group to develop a drug for rare liver and lung complaints
young girl with allergy
April 29 2019
The sell-off that followed the recent disappointment of Allergy’s PQ Birch jab means now might be a good time to invest, according to City broker finnCap

© Proactive Investors 2019

Proactive Investors Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use