Proactiveinvestors United Kingdom Motif Bio PLC https://www.proactiveinvestors.co.uk Proactiveinvestors United Kingdom Motif Bio PLC RSS feed en Sun, 19 May 2019 09:17:03 +0100 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Motif Bio meets FDA ]]> https://www.proactiveinvestors.co.uk/companies/news/219763/motif-bio-meets-fda-219763.html Motif Bio PLC (LON:MTFB, NASDAQ:MTFB) is expected to be able to chart a “path forward” for its lead drug iclaprim in the next month after a meeting with the US regulator went ahead as planned.

The company sought talks after the Food & Drug Administration declined to give the antibiotic the green light, citing in a document the need for additional data on liver toxicity.

As one of Motif’s advisers pointed out, this wasn’t a straight ‘no’.The firm has always said it was keen to discuss potential deficiencies with the information provided.

The latest meeting offered that chance, with feedback expected in the next 30 days.

“After Motif Bio has received the [FDA’s] minutes, the company will be in a position to provide an update to the market on the path forward for iclaprim,” the company said in a short investor update.

iclaprim is being developed as a treatment for acute skin infection.

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Tue, 07 May 2019 07:39:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/219763/motif-bio-meets-fda-219763.html
<![CDATA[RNS press release - Meeting with US FDA held as planned ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190503182503_14063296/ Fri, 03 May 2019 18:25:03 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190503182503_14063296/ <![CDATA[News - Motif Bio partners up with Scottish biotech to develop iclaprim as cystic fibrosis lung infection treatment ]]> https://www.proactiveinvestors.co.uk/companies/news/219454/motif-bio-partners-up-with-scottish-biotech-to-develop-iclaprim-as-cystic-fibrosis-lung-infection-treatment-219454.html Motif Bio PLC (LON:MTFB) shares gained on Wednesday as the firm revealed that it has partnered up with Scottish biotech Lamellar Biomedical to develop a treatment for lung infections in patients with cystic fibrosis (CF).

AIM-quoted Motif already owns a next generation antibiotic called iclaprim, while Lamellar’s LMS-611 is known to have mucus-clearing properties and has been shown to boost the performance of antibiotics.

READ: Motif Bio seeks talks with US drugs regulator

Iclaprim has been granted orphan drug designation in the US for Staphylococcus aureus pneumonia in patients with CF, and LMS-611 has a European orphan drug designation for the disorder.

Based on the data from each drug so far, the companies believe combining the two could create a “promising potential treatment” for CF patients with lung infections.

As part of the tie-up, Motif Bio will carry out an in vivo study evaluating iclaprim in combination with LMS-611.

“We have been looking for a way to optimise the development of iclaprim in patients with CF,” said chief executive Motif Bio.

“We are excited about the preliminary data we have seen with Lamellar's technology and look forward to evaluating it in combination with iclaprim.”

In afternoon trading, shares in Motif Bio were 7.6% higher at 9.34p.

In a note to clients, analysts at ‘house’ broker Peel Hunt commented: “This is an incremental positive for iclaprim, reminding investors of its wider potential as an antibiotic but – as a reminder – we await Motif’s perspective following the FDA meeting on 3 May in respect of icalprim’s CRL for ABSSSI (14th Feb) and, perhaps more importantly, the receipt of the meeting minutes expected c30 days afterwards (c3 June).”

 -- Adds analyst comment, updates share price --

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Wed, 01 May 2019 08:45:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/219454/motif-bio-partners-up-with-scottish-biotech-to-develop-iclaprim-as-cystic-fibrosis-lung-infection-treatment-219454.html
<![CDATA[RNS press release - Motif Signs Agreement with Lamellar Biomedical ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190501070014_14058482/ Wed, 01 May 2019 07:00:14 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190501070014_14058482/ <![CDATA[RNS press release - Notice of AGM ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190426070103_14052824/ Fri, 26 Apr 2019 07:01:03 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190426070103_14052824/ <![CDATA[RNS press release - Appointment of Andrew Powell to Board of Directors ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190426070011_14052781/ Fri, 26 Apr 2019 07:00:11 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190426070011_14052781/ <![CDATA[News - Motif Bio higher as it presents data from Phase III iclaprim trial ]]> https://www.proactiveinvestors.co.uk/companies/news/218650/motif-bio-higher-as-it-presents-data-from-phase-iii-iclaprim-trial-218650.html Motif Bio PLC (LON:MTFB) (NASDAQ:MTFB) shares rose on Tuesday as the firm delivered new data on its lead drug, iclaprim, at the European Congress of Clinical Microbiology and Infectious Diseases, in Amsterdam.

The presentation provided a drill-down into the results from the company’s REVIVE Phase III study of people with skin and skin structure infections.

READ: Motif Bio receives vote of confidence as it raises £2.7mln

Among the headlines was an analysis by lesion size, which showed the antibiotic had comparable efficacy to vancomycin, the current standard of care.

Delegates heard the bacteremia rates were comparable between the two drugs, while the pharmacokinetics of iclaprim (the way the drug moves around the body) supported the use of a fixed dosing regimen.

Finally, Motif provided details of a recent lab-based data supporting iclaprim’s activity against Gram-positive bacteria collected from patients.

“Data are being presented that show that iclaprim continues to be active against a variety of antibiotic-resistant pathogens like methicillin-resistant (MRSA), methicillin-susceptible (MSSA) Staphylococcus aureus, and other Gram-positive skin and soft structure pathogens collected during 2017 from Europe and the US,” Motif said.

In early afternoon trading in London, Motif Bio shares were 4.9% higher at 8.82p.

 -- Adds share price --

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Tue, 16 Apr 2019 07:46:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/218650/motif-bio-higher-as-it-presents-data-from-phase-iii-iclaprim-trial-218650.html
<![CDATA[RNS press release - Motif Presents New Iclaprim Data at ECCMID 2019 ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190416070015_14042103/ Tue, 16 Apr 2019 07:00:15 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190416070015_14042103/ <![CDATA[News - Motif Bio still hopeful of reaping the benefit from a productive year ]]> https://www.proactiveinvestors.co.uk/companies/news/218554/motif-bio-still-hopeful-of-reaping-the-benefit-from-a-productive-year-218554.html Securing approval in the US for iclaprim remains the top priority for Motif Bio PLC (LON:MTFB), the company said in its full-year results statement.

The company, which is scheduled to meet the US Food and Drug Administration (FDA) in early May to discuss concerns over the risk of liver toxicity for patients taking iclaprim, stressed that securing US approval is but part of a broader plan for iclaprim's long-term success.

READ: Motif Bio receives vote of confidence as it raises £2.7mln

“We expect to be joined at the meeting by two external experts and anticipate a collaborative discussion and hopefully an acceptable path forward. We believe that iclaprim can be a valuable option for patients and their providers who are in need of new antibiotic treatment options,” said Dr Graham Lumsden, the chief executive officer of Motif.

In the meantime, the company is keeping a tight watch on costs, having posted a sharply reduced loss of US$14.0mln for 2018 compared to a loss of US$44.8mln in 2017.

Research and development expenses decreased to US$11.0mln from US$29.5mln in 2017. This decrease was primarily attributable to a US$22.1 million reduction in expense for the iclaprim Phase III clinical trial programme, which was completed in 2017, although this was partially offset by a US$3.6mln increase in costs relating to regulatory and clinical operating activities, chemistry manufacturing and control requirements and other non-clinical development activities.

Cash and cash equivalents stood at around US$12.3mln at the end of 2018; since then, the company has raised US$3.3mln through a share issue.

Way forward for iclaprim

As previously mentioned, the company has enough money to get it beyond the meeting with the FDA next month and tide it over while it formulates a plan for the way forward for iclaprim after the meeting.

In a note to clients, analysts at ‘house’ broker Peel Hunt pointed out: “Our forecasts, recommendation and TP remain U/R and we await the company’s perspective following the FDA meeting on 3 May where it will discuss the points raised in the complete response letter (received 14 February) for iclaprim’s NDA.”

They added: “We note that the company has previously described that – assuming a viable route to approval can be found beyond the FDA meeting – it expects further funds to be required to resubmit an NDA, meet all obligations and reach a new approval date.”

In afternoon trading, Motif Bio shares were trading at 8.68p, down 1% on Friday’s close.

 -- Adds analyst comment, share price --

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Mon, 15 Apr 2019 07:39:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/218554/motif-bio-still-hopeful-of-reaping-the-benefit-from-a-productive-year-218554.html
<![CDATA[RNS press release - Fiscal Year 2018 Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190415070007_14040326/ Mon, 15 Apr 2019 07:00:07 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190415070007_14040326/ <![CDATA[RNS press release - Motif Bio to Present Iclaprim Data at ECCMID 2019 ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190404070013_14028240/ Thu, 04 Apr 2019 07:00:13 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190404070013_14028240/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190402174355_14026227/ Tue, 02 Apr 2019 17:43:55 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190402174355_14026227/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190401152807_14024074/ Mon, 01 Apr 2019 15:28:07 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190401152807_14024074/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190401141735_14023907/ Mon, 01 Apr 2019 14:17:35 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190401141735_14023907/ <![CDATA[News - Motif Bio receives vote of confidence as it raises £2.7mln ]]> https://www.proactiveinvestors.co.uk/companies/news/217201/motif-bio-receives-vote-of-confidence-as-it-raises-27mln-217201.html Motif Bio PLC (LON:MTFB, NASDAQ:MTFB) received a monetary boost – and by extension a vote of confidence in its prospects – as it raised £2.7mln via a share placing.

The cash will fund the business through the coming months as it meets with officials at the US Food & Drug Administration (FDA) to discuss the future of its antibiotic, iclaprim.

The treatment, which was developed to tackle acute bacterial skin infections, was knocked by the FDA last month.

The watchdog 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.

Of course, Motif is keen “to discuss potential options to address the deficiencies” with the information it had furnished. But ahead of the fundraiser, there had been real concerns the business might run out of cash.

Meeting scheduled

A meeting with the FDA is scheduled for May 3, and the company expects a response a month later.

Proceeds from the placing, which was completed at 6p a share, will provide a financial runway long enough to see it past the date it receives the minutes from the regulator in June.

Chief executive Graham Lumsden said: "We are encouraged by the support shown by both new and existing investors as we strengthen our balance sheet.

“The company now expects to be funded through completion of the FDA meeting and receipt of the minutes, which should provide guidance regarding the path forward for iclaprim."

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Tue, 26 Mar 2019 08:10:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/217201/motif-bio-receives-vote-of-confidence-as-it-raises-27mln-217201.html
<![CDATA[RNS press release - Motif Bio Raises £2.7m (US$3.55m) ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190326070017_14015167/ Tue, 26 Mar 2019 07:00:17 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190326070017_14015167/ <![CDATA[News - Motif Bio PLC says it is in the advanced stages of concluding a proposed placing to institutional and other investors ]]> https://www.proactiveinvestors.co.uk/companies/news/217110/motif-bio-plc-says-it-is-in-the-advanced-stages-of-concluding-a-proposed-placing-to-institutional-and-other-investors-217110.html Motif Bio PLC (LON:MTFB) (NASDAQ:MTFB) has confirmed that it needs to raise additional capital in the near term and said it is in the advanced stages of concluding a proposed placing of new ordinary shares to institutional and other investors.

The AIM-listed clinical-stage biopharmaceutical company, specialising in developing novel antibiotics, said the net proceeds of the proposed placing, when taken together with its existing cash resources are expected to be sufficient to fund the business beyond its meeting with the US Food & Drug Administration (FDA) scheduled for 3 May 2019.

READ: Motif Bio surges as US FDA agrees to a meeting to discuss new drug application for novel antibiotic iclaprim

At that meeting, Motif Bio will discuss the Complete Response Letter received in respect of the company's New Drug Application (NDA) for its lead novel antibiotic, iclaprim, which said additional data was needed.

The company said it expects to be able to provide guidance as to a route to approval for iclaprim upon receipt of the minutes from this meeting, which would typically be approximately 30 days from the meeting date.

The group added that assuming a viable route to approval, it is expected that further additional funds will be required to resubmit an NDA and reach a new approval date.

Motif Bio concluded: “Whilst there can be no certainty that the Proposed Placing will proceed, nor as to the quantum, pricing, or timing of any such placing the Board is seeking to conclude the process shortly and will update shareholders accordingly.”

In mid-morning trading, Motif Bio shares were 4.6% lower at 7.50p.

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Mon, 25 Mar 2019 10:06:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/217110/motif-bio-plc-says-it-is-in-the-advanced-stages-of-concluding-a-proposed-placing-to-institutional-and-other-investors-217110.html
<![CDATA[RNS press release - Proposed Equity Fundraise ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190325094953_14014125/ Mon, 25 Mar 2019 09:49:53 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190325094953_14014125/ <![CDATA[News - Motif Bio surges as US FDA agrees to a meeting to discuss new drug application for novel antibiotic iclaprim ]]> https://www.proactiveinvestors.co.uk/companies/news/216830/motif-bio-surges-as-us-fda-agrees-to-a-meeting-to-discuss-new-drug-application-for-novel-antibiotic-iclaprim-216830.html Motif Bio PLC (LON:MTFB) (NASDAQ:MTFB), saw its shares surge on Wednesday after the biopharmaceutical company said the US Food & Drug Administration (FDA) has agreed to a meeting to discuss its need for additional data related to the new drug application for Motif’s novel antibiotic, iclaprim

The AIM-listed firm said the meeting with the US watchdog is scheduled to take place on 3 May 2019, with official meeting minutes typically received from the FDA within 30 days of a meeting. 

READ: Motif Bio seeks talks with FDA after iclaprim setback

After this, Motif Bio said it will be in a position to provide an update to the market on the path forward for iclaprim, which has been developed for the treatment of acute bacterial skin and skin structure infections.

Graham Lumsden, Motif Bio’s chief executive officer said:  "We are pleased that the FDA has granted our meeting request and that critical personnel from the FDA have been invited to attend the upcoming meeting with our internal and external experts.

“We look forward to a collaborative meeting and to discussing with the Agency the best way to move iclaprim towards marketing approval."

Financing

As previously announced, the company also reaffirmed that it needs to raise additional capital in the near term, with a further update regarding financing to be made in due course.

In early afternoon trading in London, Motif Bio shares were 52% higher at 9.00p.

The company said on 14 February that it had requested a meeting after the FDA said it wouldn’t be giving the regulatory green light to the company’s antibiotic, iclaprim.

In what is called a complete response letter, the FDA indicated additional data would be required “to further evaluate the risk for liver toxicity” before granting approval.

 -- Updates share price --

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Wed, 20 Mar 2019 09:51:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/216830/motif-bio-surges-as-us-fda-agrees-to-a-meeting-to-discuss-new-drug-application-for-novel-antibiotic-iclaprim-216830.html
<![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190320070010_14008316/ Wed, 20 Mar 2019 07:00:10 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190320070010_14008316/ <![CDATA[RNS press release - Motif Bio Granted Meeting with U.S. FDA ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190320070006_14008292/ Wed, 20 Mar 2019 07:00:06 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190320070006_14008292/ <![CDATA[News - Motif Bio appoints long-standing board member Bruce Williams as interim chairman, replacing Richard C.E. Morgan ]]> https://www.proactiveinvestors.co.uk/companies/news/216618/motif-bio-appoints-long-standing-board-member-bruce-williams-as-interim-chairman-replacing-richard-ce-morgan-216618.html Motif Bio PLC (LON:MTFB) (NASDAQ:MTFB) has appointed long-standing board member Bruce Williams as its interim chairman to replace Richard C.E. Morgan who is stepping down with immediate effect to focus on other business commitments.

The AIM-listed group said Morgan has agreed to remain available to the company in the coming months on an as needed basis to ensure a smooth transition.

READ: Motif Bio to manage cash aggressively after making loan repayment

The company pointed out that Williams has significant operational experience in the biopharmaceutical industry and has held senior leadership positions at both large pharmaceutical firms and start-up biotechs.

It said he served as senior vice president, global business management at Enzon Pharmaceuticals, where he led the company's commercial functions, prior to that, he was senior vice president, sales & marketing at Genta Incorporated.

Graham Lumsden, Motif Bio’s chief executive officer commented: "We are delighted that Bruce has agreed to step into the interim Chairman role. He is a strong leader who has held senior executive positions, particularly in strategic product planning and commercialisation, at a number of biopharmaceutical companies.”

The CEO added: “I look forward to continuing to work with him as Motif Bio seeks to advance iclaprim towards approval. We have submitted a meeting request and package to the FDA and expect to work collaboratively with the Agency over the coming weeks."

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Mon, 18 Mar 2019 08:05:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/216618/motif-bio-appoints-long-standing-board-member-bruce-williams-as-interim-chairman-replacing-richard-ce-morgan-216618.html
<![CDATA[RNS press release - Appointment of Bruce Williams as Interim Chairman ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190318070007_14005028/ Mon, 18 Mar 2019 07:00:07 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190318070007_14005028/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190315070105_14003292/ Fri, 15 Mar 2019 07:01:05 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190315070105_14003292/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190307120742_13994286/ Thu, 07 Mar 2019 12:07:42 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190307120742_13994286/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190307120215_13994267/ Thu, 07 Mar 2019 12:02:15 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190307120215_13994267/ <![CDATA[News - Motif Bio seeks talks with US drugs regulator ]]> https://www.proactiveinvestors.co.uk/companies/news/215068/motif-bio-seeks-talks-with-us-drugs-regulator-215068.html 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.

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Thu, 21 Feb 2019 14:58:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/215068/motif-bio-seeks-talks-with-us-drugs-regulator-215068.html
<![CDATA[RNS press release - Conference Call and Webcast ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190219070006_13973516/ Tue, 19 Feb 2019 07:00:06 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190219070006_13973516/ <![CDATA[News - Motif Bio to manage cash aggressively after making loan repayment ]]> https://www.proactiveinvestors.co.uk/companies/news/214781/motif-bio-to-manage-cash-aggressively-after-making-loan-repayment-214781.html Motif Bio Plc (LON:MTFB, NASDAQ:MTFB) 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 US$3mln in cash following the payment to Hercules Capital. It still owes US$7.7mln to Hercules.

Motif will have to make a further US$500,000 repayment in 90 days, or by May 18, depending on whether it is able to raise at least US$2mln.

In a statement released Monday, the company said there will be a three-month interest-only period on the remaining loan, and that Hercules has waived any prepayment charges. 

As a result, future interest and amortisation payments will be substantially lower than before, it added.

“Though the company remains in compliance with the terms of its loan agreement, it has agreed to this amendment in order to avoid unilateral action by Hercules based upon any position that Hercules may take that the company is in default,” Motif added.

The loan repayment follows the decision by the US Food & Drug Administration not to grant regulatory clearance to the company’s next-generation antibiotic, iclaprim.

Motif is seeking talks with the FDA, which has said additional data would be required “to further evaluate the risk for liver toxicity” before granting approval.

It is currently consulting with internal and external experts to prepare the information required by the drug regulator.

Once requested, it normally takes between a month and six weeks before a meeting with FDA officials takes place.

“However, there can be no guarantee as to the date of a meeting with the FDA and no certainty that the funds available to the company, without an additional capital raise, will enable it to reach this date,” Motif warned.

“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.”

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Mon, 18 Feb 2019 07:27:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/214781/motif-bio-to-manage-cash-aggressively-after-making-loan-repayment-214781.html
<![CDATA[RNS press release - Amendment Agreement with Hercules Capital ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190218070008_13971960/ Mon, 18 Feb 2019 07:00:08 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190218070008_13971960/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190215162840_13971681/ Fri, 15 Feb 2019 16:28:40 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190215162840_13971681/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190215162646_13971680/ Fri, 15 Feb 2019 16:26:46 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190215162646_13971680/ <![CDATA[News - Motif Bio seeks talks with FDA after iclaprim setback ]]> https://www.proactiveinvestors.co.uk/companies/news/214611/motif-bio-seeks-talks-with-fda-after-iclaprim-setback-214611.html Motif Bio Plc (LON:MTFB, NASDAQ:MFTB) said it has requested a meeting with the Food & Drug Administration after the US watchdog said it wouldn’t be giving the regulatory green light to the company’s antibiotic, iclaprim.

In what’s called a complete response letter, the FDA indicated additional data would be required “to further evaluate the risk for liver toxicity” before granting approval.

READ: Motif Bio to present positive iclaprim drug data in the US this week

Motif, which developed the treatment for acute bacterial skin and skin structure infections, said it is keen to “to discuss potential options to address the deficiencies”. According to chief executive Graham Lumsden, his team may have to wait between 30-45 days before having the opportunity to do so.

"We look forward to working with the agency to discuss options to advance iclaprim towards approval," he said.

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Thu, 14 Feb 2019 07:20:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/214611/motif-bio-seeks-talks-with-fda-after-iclaprim-setback-214611.html
<![CDATA[RNS press release - Complete Response Letter from the FDA ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190214070007_13968786/ Thu, 14 Feb 2019 07:00:07 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190214070007_13968786/ <![CDATA[RNS press release - Exercise of Warrants ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190205070009_13957932/ Tue, 05 Feb 2019 07:00:09 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190205070009_13957932/ <![CDATA[RNS press release - Exercise of Warrants ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190123163105_13944603/ Wed, 23 Jan 2019 16:31:05 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190123163105_13944603/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181101164048_13852158/ Thu, 01 Nov 2018 16:40:48 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181101164048_13852158/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181101163544_13852152/ Thu, 01 Nov 2018 16:35:44 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181101163544_13852152/ <![CDATA[RNS press release - Jefferies London Healthcare Conference ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181031070007_13848556/ Wed, 31 Oct 2018 07:00:07 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181031070007_13848556/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181030163522_13848245/ Tue, 30 Oct 2018 16:35:22 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181030163522_13848245/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181016164037_13831164/ Tue, 16 Oct 2018 16:40:37 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181016164037_13831164/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181016163532_13831154/ Tue, 16 Oct 2018 16:35:32 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181016163532_13831154/ <![CDATA[News - Motif Bio to present positive iclaprim drug data in the US this week ]]> https://www.proactiveinvestors.co.uk/companies/news/206277/motif-bio-to-present-positive-iclaprim-drug-data-in-the-us-this-week-206277.html Motif Bio PLC (LON:MTFB) plans to present data showing the safety and efficacy of its next-generation antibiotic iclaprim compared to the current gold standard medication, vancomycin.

The company said on Wednesday that it plans to present its data and the results of the REVIVE Phase 3 trials at IDWeek being held in San Francisco later this week.

READ: Pooled data from phase III trials confirms Motif Bio’s iclaprim drug is safer than gold standard

Motif Bio said 50% (602 out of 1198) of the REVIVE intent-to-treat (ITT) population had wound infections and that iclaprim was just as effective as vancomycin, based on an early clinical response of a subgroup of patients with wound infections. 

The company also repeated that its drug was found not to negatively affect patients’ kidney function, a key issue for some people taking rival treatments. None of the patients taking iclaprim showed signs of kidney toxicity, compared to two patients in the vancomycin arm.

"Wound infections, including surgical site infections, can be difficult to treat and it was important to see that iclaprim was non-inferior to standard of care in treating these types of infections,” G. Ralph Corey, MD, Vice Chair for Education and Global Health and Gary Hock Professor at Duke University School of Medicine and a principal investigator in the REVIVE-2 trial, said in a statement.

“Iclaprim, if approved, could be a valuable treatment option for patients with wound infections … including patients with co-morbidities known to increase the risk of vancomycin-associated acute kidney injury, such as renal impairment, diabetes and obesity," he added.

Shares in Motif Bio were flat at 34.95p in early trade.

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Wed, 03 Oct 2018 09:19:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/206277/motif-bio-to-present-positive-iclaprim-drug-data-in-the-us-this-week-206277.html
<![CDATA[RNS press release - Motif Bio Presents New Iclaprim Data at IDWeek ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181003080101_13814474/ Wed, 03 Oct 2018 08:01:01 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20181003080101_13814474/ <![CDATA[RNS press release - Motif Bio Notes Statement from Amphion Innovations ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20180928070101_13808094/ Fri, 28 Sep 2018 07:01:01 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20180928070101_13808094/ <![CDATA[News - Motif Bio waiting on FDA approval of iclaprim after “tremendous” first half ]]> https://www.proactiveinvestors.co.uk/companies/news/205625/motif-bio-waiting-on-fda-approval-of-iclaprim-after-tremendous-first-half-205625.html Motif Bio Plc (LON:MTFB) hopes to launch its next-generation antibiotic in the first half of 2019 as it waits on the green light from US regulators.

A new drug application (NDA) for iclaprim was filed with the US Food and Drug Administration earlier this year, and a decision is due by February 13 2019.

“Our primary focus is ensuring a successful launch and commercialisation in the first half of 2019, assuming that iclaprim is approved for marketing by the FDA,” said chief executive Graham Lumsden in the half-year report.

Iclaprim safer than current standard of care

The latest data from two phase III studies looking at the effect of the drug on patients with acute bacterial skin and skin structure infections (ABSSSI) showed that the antibiotic just as good as (the technical term is ‘non-inferior to’) the current gold standard medication, vancomycin.

Importantly though, it looks to be safer, especially in obese patients or those with kidney issues.

READ: Data from phase III trials confirms iclaprim is safer than gold standard

In the studies, no deaths were reported among the iclaprim-treated patients compared to three in the vancomycin group.

Motif also repeated that its drug was found not to negatively affect patients’ kidney function, a key issue for some people taking rival treatments.

None of the patients taking iclaprim showed signs of kidney toxicity, whereas seven patients did in the vancomycin arm.

Save hospitals time and money

Motif Bio believes iclaprim can save hospitals, and patients, money by reducing the amount of after-care required for patients who develop kidney complications as a result of taking vancomycin.

At the moment, just over 9% of hospitalised ABSSSI patients treated with vancomycin suffer from vancomycin-associated acute kidney injury, which extends hospital length-of-stay by five days.

Generally, those patients require a specialist nephrology physician consultation and acute dialysis, which can be costly.

More than just ABSSSI?

One key issue with almost all antibiotics is that some bacteria have become resistant to their effects, rendering them useless.

Motif has previously presented data showing that iclaprim still works on a variety of antibiotic-resistant pathogens such as methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) Staphylococcus aureus.

The Cystic Fibrosis Foundation is also funding important in vitro (outside of the body) testing to help develop iclaprim as a treatment for cystic fibrosis patients suffering from lung infections.

“Tremendous” first half

“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,” said Lumsden.

“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.”

For the six months ended June 30, Motif posted a net loss of US$7.8mln (H1 17: US$29.7mln), reflecting a big fall in R&D costs.

At the end of the period, the company had US$19.8mln of cash in the bank, compared with US$22.7mln a year ago.

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Tue, 25 Sep 2018 09:00:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/205625/motif-bio-waiting-on-fda-approval-of-iclaprim-after-tremendous-first-half-205625.html
<![CDATA[RNS press release - Half-year Report ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20180925070018_13802890/ Tue, 25 Sep 2018 07:00:18 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20180925070018_13802890/ <![CDATA[RNS press release - Upcoming Scientific Conferences ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20180920070017_13797561/ Thu, 20 Sep 2018 07:00:17 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20180920070017_13797561/ <![CDATA[News - Motif Bio: Latest data burnishes the credentials of new antibiotic ]]> https://www.proactiveinvestors.co.uk/companies/news/204197/motif-bio-latest-data-burnishes-the-credentials-of-new-antibiotic-204197.html Data will be presented at a conference that suggests Motif Bio Plc’s (LON:MTFB) next-generation antibiotic has a number of advantages over the current crop of drugs designed to combat infection.

A review of the two phase III studies carried out on iclaprim showed there were fewer adverse events among diabetic patients taking the drug than those on the standard of care, a treatment called Vancomycin.

Drilling down, the statistical read-out showed no patients in the iclaprim group developed kidney injury, compared with three on Vancomycin.

Additionally, only 3.6% of the iclaprim group had to be taken off the drug compared with 10% receiving the standard of care.

Separately, surveillance data from work performed in the lab has confirmed iclaprim has the potential to work against a wide variety of Gram-positive bacteria, including drug-resistant strains.

Need for new antibiotics

"Given the worldwide crisis in antibiotic resistance, there remains a major need for new antibiotic treatments,” said David Huang, Motif’s chief medical officer.

“We have shown comprehensive data indicating that iclaprim has potent activity against a wide variety of Gram-positive bacteria, including MRSA that cause severe skin infections.”

The latest statistical update will be presented later Wednesday at an industry conference being held in Lisbon.

After successfully negotiating two phase III clinical trials a new drug submission has been made to the US Food & Drug Administration, which will come back with a decision on iclaprim in February next year.

Initially, the antibiotic will be used to treat acute bacterial skin and skin structure infections.

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Wed, 05 Sep 2018 07:43:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/204197/motif-bio-latest-data-burnishes-the-credentials-of-new-antibiotic-204197.html
<![CDATA[RNS press release - Iclaprim Data presented at ESCMID/ASM Conference ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20180905070015_13778939/ Wed, 05 Sep 2018 07:00:15 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20180905070015_13778939/