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Half-year record

RNS number : 7856B

Motif Bio PLC

25 September 2018

 

 

 

now not FOR release, book OR DISTRIBUTION IN whole OR partly at once OR ultimately IN, INTO OR FROM ANY JURISDICTION the place TO do so WOULD represent A VIOLATION OF THE vital legal guidelines OR rules OF SUCH JURISDICTION.

 

Motif Bio plc and subsidiary

("Motif Bio", or "the group")

 

Motif Bio stories

Half-yr 2018 financial effects and Operational growth

 

Motif Bio plc (goal/NASDAQ: MTFB), a medical-stage biopharmaceutical business focusing on developing novel antibiotics, today introduced unaudited financial results for the half year ended June 30, 2018 and stated on its development yr up to now.

 

Graham Lumsden, CEO of Motif Bio, mentioned: "We made colossal progress right through the first half of 2018, together with finishing the submission of an NDA with the U.S. FDA for iclaprim in acute bacterial epidermis and epidermis constitution infections, which turned into authorised for overview in August with confirmation of a precedence evaluation from FDA resulting in a PDUFA date of February 13, 2019. they are continuing to construct on their achievements and are working to raise cognizance and understanding of Motif Bio and iclaprim with skills commercialization companions, the medical group and traders.  As partnering discussions progress, they proceed to consider tips on how to construct a crew of scientific Science Liaisons, Key Account Managers and professional Representatives to be able to bring iclaprim to patients in an excellent and efficient method.  Their basic center of attention is guaranteeing a successful launch and commercialization in the first half of 2019, assuming that iclaprim is accepted for advertising through the FDA."

 

corporate and construction Highlights - 2018 yr thus far:

 

·      New Drug application ("NDA") submitted to the U.S. meals & Drug Administration ("FDA") for investigational drug candidate iclaprim for treatment of sufferers with acute bacterial skin and epidermis structure infections ("ABSSSI").   The NDA become permitted for filing through FDA and granted priority evaluate.  The FDA has set a target action date beneath the Prescription Drug consumer charge Act ("PDUFA") of February 13, 2019.

 

·      note of Allowance got from the us Patent and Trademark office for united states Patent application Nos. 15/586,021 and 15/586,815 for the use of iclaprim to deal with patients with bacterial infections. the two method of use patents will expire in November 2037.

 

·      New iclaprim statistics introduced at key infectious sickness conferences, including American Society of Microbiology (ASM) Microbe in Atlanta, GA, country and 28th European Congress of medical Microbiology and Infectious ailments (ECCMID) in Madrid, Spain.

 

·      results of REVIVE-2 part three trial in ABSSSI posted in peer-reviewed journal, Antimicrobial agents and Chemotherapy.

 

·      Their operational group turned into strengthened by the appointment of Stephanie Noviello, MD, MPH, as vp, clinical development.

 

·      Award received from the Cystic Fibrosis groundwork to fund critical in vitro trying out that allows you to assist to develop the building of iclaprim for the treatment of lung infections in sufferers with cystic fibrosis.

 

 

 

economic Highlights

 

·      net loss for the six months ended June 30, 2018 and 2017 became US$7.8 million and US$29.7 million, respectively.

 

·      normal and administrative fees diminished via US$0.5 million to US$4.1 million within the six months ended June 30, 2018 from US$four.6 million within the six months ended June 30, 2017. This reduce was primarily because of a US$0.6 million reduction in inventory-primarily based compensation and a US$0.2 million discount in criminal, investor family members and different knowledgeable services. This lower was partly offset by using a US$0.3 million boost in employee compensation.

 

·      analysis and development costs reduced by means of US$16.7 million to US$6.9 million in the six months ended June 30, 2018 from US$23.6 million within the six months ended June 30, 2017. This lessen became basically brought on by a US$20.6 million discount in fee for their REVIVE phase 3 scientific trial application, which become completed in 2017.

 

·      On may 17, 2018, they raised US$12.7 million of net proceeds, after deducting US$0.7 million of issuance charges, from a placement of 32,258,064 new typical shares at 31 pence per share to both existing and new investors.

 

·      At June 30, 2018 and December 31, 2017, they had money and cash equivalents of US$19.eight million and US$22.7 million, respectively.

 

 

For additional information, please contact:

 

Motif Bio plc

[email protected]

Graham Lumsden (Chief executive Officer)

 

 

 

Peel Hunt LLP (NOMAD & broking service)

+ 44 (0)20 7418 8900

Dr. Christopher Golden

 

Oliver Jackson

 

 

 

Northland Capital companions restricted (broker)

+forty four (0)203 861 6625

David Hignell/Vadim Alexandre/Rob Rees

 

 

 

Walbrook PR Ltd. (UK financial PR & IR)

+forty four (0) 20 7933 8780

Paul McManus/Helen Cresswell/Lianne Cawthorne

 

 

 

MC features AG (EUROPEAN IR)

+forty nine (0)89 210 2280

Raimund Gabriel

             [email protected]

 

 

Solebury Trout (U.S. IR)

+ 1 (646) 378-2963

Meggie Purcell

              [email protected]

 

 

Russo partners (U.S. PR)

+1 (858) 717-2310 or +1 (212) 845 4272

David Schull

[email protected]

Travis Kruse, Ph.D.

[email protected]

 

 

     

 

 

 

 

Notes to Editors:

 

About Motif Bio

 

Motif Bio plc (goal/NASDAQ: MTFB) is a scientific-stage biopharmaceutical company focused on developing novel antibiotics for hospitalised patients and designed to be valuable against critical and life-threatening infections brought about by multi-drug resistant Gram-positive micro organism, including MRSA. The enterprise's lead product candidate is iclaprim. Following tremendous results from two phase 3 trials (REVIVE-1 and REVIVE-2), a brand new Drug application (NDA) changed into submitted to the U.S. food & Drug Administration (FDA) for the treatment of acute bacterial skin and epidermis constitution infections (ABSSSI) and is now under review, with a PDUFA date of February 13, 2019. more than three.6 million sufferers with ABSSSI are hospitalised yearly within the U.S. it's estimated that up to 26% of hospitalized ABSSSI sufferers have renal impairment.

 

The enterprise additionally plans to strengthen iclaprim for medical institution acquired bacterial pneumonia (HABP), together with ventilator linked bacterial pneumonia (VABP), as there is a high unmet want for new remedies during this indication.  A part 2 trial in patients with HABP has been effectively completed and a section three trial is being planned. additionally, iclaprim has been granted orphan drug designation by the FDA for the treatment of Staphylococcus aureus lung infections in sufferers with cystic fibrosis and is in preclinical building for this indication.

 

Iclaprim has received certified Infectious disease Product (QIDP) designation from the FDA together with quickly track popularity for the ABSSSI indication. If authorized for the ABSSSI indication as a brand new Chemical Entity, iclaprim can be eligible for 10 years of market exclusivity within the U.S. from the date of first approval, under the generating Antibiotic Incentives Now Act (the benefit Act). In Europe, 10 years of market exclusivity is predicted.

 

Motif is building a patent property to provide further insurance policy for iclaprim.  On August eight, 2018 the business introduced that it had acquired a observe of Allowance from the USA Patent and Trademark workplace for united states Patent application Nos. 15/586,021 and 15/586,815.  The claims relate to the use of iclaprim to deal with sufferers with bacterial infections, together with however no longer restrained to acute bacterial dermis and dermis structure infections, medical institution-bought 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 functions were and are anticipated to be filed that are designed to protect their proprietary applied sciences, including processes for manufacturing the iclaprim energetic pharmaceutical ingredient and therapeutic formulations, their use in pharmaceutical preparations and strategies of treating disease with iclaprim.

 

ahead-looking Statements

 

This press free up contains forward-searching statements. phrases comparable to "predict," "consider," "intend," "plan," "continue," "might also," "will," "count on," and identical expressions are intended to determine forward-looking statements. ahead-looking statements involve popular and unknown dangers, uncertainties and other important factors that could cause Motif Bio's exact effects, efficiency or achievements to be materially distinct from any future results, performance or achievements expressed or implied by the ahead-looking statements. Motif Bio believes that these components encompass, however aren't restrained to, (i) the timing, growth and the effects of medical trials for Motif Bio's product candidates, (ii) the timing, scope or probability of regulatory filings and approvals for Motif Bio's product candidates, (iii) Motif Bio's capability to correctly commercialise its product candidates, (iv) Motif Bio's capacity to readily market any product candidates that receive regulatory approval, (v) Motif Bio's commercialisation, advertising and marketing and manufacturing capabilities and method, (vi) Motif Bio's expectation regarding the protection and efficacy of its product candidates, (vii) the advantage clinical utility and benefits of Motif Bio's product candidates, (viii) Motif Bio's ability to improve its product candidates via quite a few tiers of construction, particularly via pivotal safeguard and efficacy trials, (ix) Motif Bio's estimates related to the skills market chance for its product candidates, and (x) the components mentioned within the section entitled "possibility factors" in Motif Bio's Annual record on form 20-F filed with the SEC on April 10, 2018, which is accessible on the SEC's internet website, www.sec.gov. Motif Bio undertakes no duty to update or revise any ahead-searching statements.

 

 

administration's dialogue and evaluation of fiscal condition and effects of Operations

Overview

 

we are a medical stage biopharmaceutical enterprise engaged within the analysis, development and commercialization of novel antibiotics designed to be effective in opposition t severe and existence-threatening infections in hospitalized patients caused by way of multi-drug resistant micro organism. the invention of latest antibiotics has not stored tempo with the increasing incidence of resistant, difficult-to-deal with micro organism. one of the biggest threats of antibiotic resistance is from methicillin resistant Staphylococcus aureus ("MRSA"), a number one reason behind sanatorium-bought infections and a becoming explanation for infections in suit americans in the ordinary group. In 2013, the centers for disorder handle and Prevention ("CDC") mentioned that at least two million individuals grew to become contaminated with antibiotic-resistant bacteria and at least 23,000 americans died as a direct outcomes of these infections. Their lead product candidate, iclaprim, is being developed for the medicine of acute bacterial dermis and dermis structure infections ("ABSSSI") and health facility-got bacterial pneumonia ("HABP"), including ventilator-linked bacterial pneumonia ("VABP"), infections that are often brought about by using MRSA. Iclaprim is also being developed to deal with lung infections brought about via Staphylococcus aureus in patients with cystic fibrosis.

 

On June 14, 2018, they announced the completion of a rolling submission of a brand new Drug utility ("NDA") to the U.S. meals & Drug Administration ("FDA") for their investigational drug candidate iclaprim in sufferers with ABSSSI.  This follows the a success completion of their two global REVIVE part 3 clinical trials with an IV formulation of iclaprim, for the medication of ABSSSI. The pre-detailed FDA primary endpoints of non-inferiority of early scientific response of iclaprim at the early time factor had been met.

 

On August 14, 2018, they introduced the FDA's acceptance of their NDA submission for iclaprim in patients with ABSSSI.  The FDA granted their NDA a priority overview and set a goal determination date under the Prescription Drug user price Act (PDUFA) of February 13, 2019.

 

Iclaprim is a novel diaminopyrimidine antibiotic that inhibits an essential bacterial enzyme known as "dihydrofolate reductase" ("DHFR"). Diaminopyrimidines are a category of chemical compounds that inhibit different enzymes in the production of tetrahydrofolate, a form of folic acid, which is required for the production of bacterial DNA and RNA. The inhibition of DHFR represents a differentiated and under-utilized mechanism of action in comparison with different antibiotics. They obtained iclaprim from Nuprim Inc. ("Nuprim"), following the completion of their merger with Nuprim on April 1, 2015. Arpida AG ("Arpida"), one of the vital old house owners of iclaprim, accomplished a complete construction software for iclaprim, together with two phase three trials in advanced skin and dermis structure infections ("cSSSI"). Iclaprim is a targeted Gram-fine antibiotic that's swiftly bactericidal and highly mighty in opposition t MRSA and different Gram-wonderful micro organism in vitro.  "Gram-fine" or "Gram-negative" refer to how bacteria react to the Gram stain examine in line with the outer casing of the micro organism, and the bacterial cellphone wall constitution. every category of bacteria can be associated with different ailments.  to date, iclaprim has been studied in over 1,400 sufferers and fit volunteers. Vancomycin, a standard of care antibiotic in hospitalized sufferers with infections caused with the aid of Gram-tremendous micro organism, is linked to nephrotoxicity (i.e., hurt to the kidneys caused by way of exposure to a poisonous chemical, toxin or remedy), together with vancomycin-associated acute kidney harm ("VA-AKI"). Therapeutic drug monitoring ("TDM") and dosage adjustment in patients with renal impairment is required with vancomycin. In contrast to vancomycin, iclaprim is minimally excreted by the use of the kidneys (<2% of the administered dose changed into recovered within the urine), and neither TDM nor dosage adjustment have been required and no nephrotoxicity changed into viewed with iclaprim in the REVIVE section three medical trials. Iclaprim has also confirmed a low propensity for resistance building in vitro.

 

We trust that iclaprim is competencies candidate for use as a first-line empiric monotherapy, the preliminary therapy administered prior to the identification of the pathogen, in severely sick patients who are hospitalized with ABSSSI and have comorbidities, or additionally endure from different health considerations, equivalent to renal impairment or diabetes. Renal impairment influences as much as an estimated 936,000 of the about three.6 million sufferers hospitalized with ABSSSI yearly in the united states.

 

On September 15, 2017, they additionally introduced that the FDA granted Orphan Drug Designation to iclaprim for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis. This designation supplies special status to a drug or biologic under construction to deal with a rare sickness or circumstance and qualifies the sponsor of the product for a considerable number of construction incentives, including tax credits for certified clinical testing, waiver of person costs and probably up to seven years of market exclusivity for the given indication, if accredited. They continue to believe that iclaprim can be a positive agent for HABP. A section 3 trial is being planned and graduation remains area to funding.

 

Outlook

 

As they look forward to the FDA's decision on the approval of iclaprim, with a scheduled PDUFA date of February 13, 2019, they stay focused on optimizing their commercialization approach for iclaprim and guaranteeing a a hit drug launch within the U.S. In parallel with partnering discussions, we're evaluating how you can build the applicable group ahead of launch as well as complementary strategic increase alternatives. As they close their PDUFA date, they continue to evaluate further capital raising opportunities to fund their growth and continuing operations and predict that a favorable resolution by way of the FDA might be a key driver of future cost in the enterprise.

 

consequences of Operations:

 

assessment of the six months ended June 30, 2018 and June 30, 2017

 

conventional and Administrative prices

normal and administrative expenses lowered by way of US$0.5 million to US$four.1 million in the six months ended June 30, 2018 from US$4.6 million within the six months ended June 30, 2017. This lower was essentially as a result of a US$0.6 million discount in stock-based compensation, which changed into larger within the 2017 length partially because of a in the past disclosed out-of-length correction and a US$0.2 million discount in felony, investor relations and other skilled costs.  This lower changed into partially offset with the aid of a US$0.3 million increase in worker compensation.

 

analysis and construction charges

research and building fees decreased by way of US$16.7 million to US$6.9 million within the six months ended June 30, 2018 from US$23.6 million in the six months ended June 30, 2017. This decrease became primarily because of a US$20.6 million discount in price for their part three medical trial software, which was achieved in 2017. This lessen changed into partly offset by using a US$3.8 million boost in costs concerning regulatory and medical operating actions, chemistry, manufacturing and manage ("CMC") requirements and different non-medical construction activities.

 

hobby salary and interest expense

hobby profits turned into US$9 thousand for the six months ended June 30, 2018, compared to US$52 thousand for the six months ended June 30, 2017. activity profits is earned based on money holdings right through the duration. interest price changed into US$1.1 million for the six months ended June 30, 2018 because of pastime on their US$15.0 million mortgage with Hercules Capital Inc. drawn in November 2017 as neatly because the amortization of deferred financing expenses from the Hercules mortgage. There turned into no excellent debt or activity cost all over the six months ended June 30, 2017. 

 

gain (Loss) from Revaluation of spinoff Liabilities

In November 2016, they issued warrants which are labeled as a legal responsibility due to capabilities variability within the number of shares that may be issued upon recreation if they fail to keep a great registration commentary. They issued further warrants in 2017 that are also classified as a derivative legal responsibility. These by-product liabilities are carried at reasonable cost and are remeasured each reporting period using the Black-Scholes choice pricing model. Their stock price has a significant have an impact on on the cost of the legal responsibility and, in ordinary, a lower in their inventory fee will decrease their derivative legal responsibility stability and decrease the loss from revaluation of their spinoff liabilities, or cause us to respect a profit from revaluation of their spinoff liabilities. The profit for the six months ended June 30, 2018 became US$four.three million, compared to a lack of US$1.4 million for the six months ended June 30, 2017.

 

web foreign alternate Loss

The internet overseas change loss for the six months ended June 30, 2018 became US$0.1 million, in comparison to a loss of US$0.1 million in the six months ended June 30, 2017. In both intervals the loss diagnosed pertains to the re-dimension of their Sterling denominated cash deposits to US bucks at the closing US dollar to Sterling exchange cost as neatly as the gains and losses resulting from the contract of transactions denominated in overseas foreign money.

 

As prior to now disclosed, their interim economic statements for the six months ended June 30, 2017 encompass a cumulative adjustment of $1.1 million for the correction of a previous length error. stock primarily based compensation price changed into understated primarily as a result of recognizing fee simplest when an award vested, no longer over the mandatory provider duration using a graded vesting approach as required below IFRS 2. The community in the past assessed the materiality of the out-of-length adjustment on all impacted intervals and concluded that the cumulative adjustment to appropriate the error may still be recorded within the six months ended June 30, 2017. The adjustment did not have an have an impact on on the money elements of the neighborhood.

 

Our unaudited period in-between condensed consolidated remark of comprehensive loss for the six months ended June 30, 2017 offered herein comprises a US$0.2 million reclassification from analysis and construction to accepted and administrative expense. This reclassification had no impact on the stated operating results and cash flows for the period.

 

Liquidity and Capital substances

 

At June 30, 2018 and December 31, 2017, they had money and money equivalents of about US$19.eight million and US$22.7 million, respectively.

 

We do not are expecting to generate significant earnings unless and until they attain regulatory popularity of and commercialize their current or any future product candidates. They anticipate that we'll continue to generate losses in the near time period as they are seeking regulatory approvals for their product candidates and begin to commercialize any approved products. they are discipline to all the dangers applicable to the building of recent medicine, and they might also come across unforeseen charges, difficulties, complications, delays and different unknown components that can also harm their company.

 

Our operations have been financed essentially with the aid of internet proceeds from the issuance of usual shares on the goal Market of the London inventory exchange, issuance of yank Depository Shares ("ADSs") on the NASDAQ Capital Market, the net proceeds of their Hercules personal loan settlement entered into in November 2017 and, previous to 2016, the issuance of convertible promissory notes to related events. Their primary uses of capital are, and they are expecting will proceed to be in the brief time period, expenses associated with the manufacturing and commercialization of their product candidate as well as compensation-related expenses.

 

cash used to fund operating charges is plagued by the timing of once they pay prices, as reflected in the exchange in their surprising debts payable and accrued fees.

 

Our future funding necessities will depend upon many components, which can also consist of right here:

·      the can charge, timing and effects of pursuing regulatory approvals;

·      the terms and timing of any collaborative, licensing and different preparations that they may also set up, including any required milestone and royalty funds thereunder; and

·      the can charge and timing of organising administrative, income, advertising and marketing and distribution capabilities;

·      the cost and timing of expertise in-licensing, acquisitions or similar transactions;

·      the scope, cost of development, consequences and cost of future preclinical experiences and clinical trials and other connected actions;

·      the charge of components, construction, manufacturing of clinical elements and establishing business materials of our latest product candidates and any different product candidates that we can also increase, in-license or purchase;

·      the emergence of competing applied sciences and their reaching industrial success earlier than they do or other adverse market developments.

 

We predict to proceed to incur losses. Their ability to obtain and hold profitability is determined by the successful development, regulatory approval and commercialization of their product candidates and attaining a degree of revenues sufficient to assist their cost constitution. They may additionally never obtain profitability, and except and except they do, they will continue to should raise additional capital. They should be required to elevate further capital through equity or debt financings within the subsequent year to continue the building and commercialization of latest product candidates and to continue to fund operations on the current money expenditure degrees. If they are unable to elevate further capital when required or on applicable terms, they may need to (i) greatly delay, scale lower back or discontinue the building and/or commercialization of 1 or more product candidates; (ii) seek collaborators for product candidates at an prior stage than otherwise could be alluring and on terms that are much less favorable than may in any other case be accessible; or (iii) relinquish or otherwise eliminate rights to technologies, product candidates or products that we'd otherwise are seeking to advance or commercialize ourselves on negative phrases.

 

 

 

cash Flows

 

Six months ended

 

 June 30, 2018

 

June 30, 2017

(in lots)

US$

 

US$

web money (utilized in) / supplied through:

 

 

 

    operating actions

(14,872)

 

(sixteen,486)

    Financing activities

12,048

 

24,124

impact of exchange fee alterations on money and money equivalents

(22)

 

34

 

(2,846)

 

7,672

 

operating activities

net cash used in operating activities turned into US$14.9 million in the six months ended June 30, 2018, basically from regulatory and clinical operating actions, together with actions helping their NDA submission, and a $4.1M reduction in present liabilities. web cash utilized in working actions became US$16.5 million for the six months ended June 30, 2017, which primarily reflects the scientific construction of iclaprim.

 

Financing actions

net cash provided by way of financing activities amounted to US$12.1 million within the six months ended June 30, 2018, basically as a result of web proceeds of US$12.7 million from the might also 17, 2018 placement of 32,258,064 new normal shares at 31 pence per share and US$0.1 million of proceeds from warrant and option exercises.  These proceeds had been in part offset via US$0.eight million in cash hobby paid beneath their Hercules personal loan settlement.  For the six months ended June 30, 2017, net cash provided of $24.1 million become essentially from the June 23, 2017 placement of 66,666,667 new general shares at 30 pence per share.

 

 

monetary Statements:

 

 

Motif Bio plc

Unaudited meantime condensed consolidated statements of comprehensive loss

For the six months June 30, 2018 and 2017

(in thousands, except share and per share information)

 

 

 

 

 

 

 

 

 

For the six months ended

 

 

 

 

June 30,

 

note

 

 

2018

 

2017

 

 

 

 

 

US $

 

US $

 

Operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

prevalent and administrative expenses

2

 

 

(4,138)

 

  (four,621)

 

research and development costs

2

 

 

(6,877)

 

(23,601)

 

 

 

 

 

 

 

 

 

operating loss

 

 

 

(eleven,015)

 

(28,222)

 

 

 

 

 

 

 

 

 

hobby salary

three

 

 

9

 

       fifty two

 

interest cost

three

 

 

(1,055)

 

-

 

profit (loss) from revaluation of spinoff liabilities

8

 

 

four,360

 

(1,427)

 

internet international exchange loss

       

 

 

(67)

 

     (116)

 

 

 

 

 

 

 

 

 

Loss before revenue taxes

 

 

 

(7,768)

 

(29,713)

 

salary tax expense

4

 

 

(9)

 

                  -  

 

 

 

 

 

 

 

 

 

net loss for the period

 

 

 

(7,777)

 

(29,713)

 

 

 

 

 

 

 

 

 

complete finished loss for the duration

 

 

 

(7,777)

 

(29,713)

 

 

 

 

 

 

 

 

 

internet loss per share

5

 

 

 

 

 

 

simple

 

 

 

(0.03)

 

           (0.15)

 

Diluted

 

 

 

(0.04)

 

           (0.15)

 

Weighted ordinary variety of general shares

 

 

 

 

 

 

 

primary

 

 

 

272,199,780

 

199,299,910

 

Diluted

 

 

 

277,586,288

 

199,299,910

 

 

The accompanying footnotes are an essential component of these condensed consolidated interim financial statements.  

Motif Bio plc

 

Unaudited intervening time condensed consolidated statements of monetary place

 

At June 30, 2018 and December 31, 2017

 

(in heaps)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

be aware

 

At June 30,

2018

 

At December 31, 2017

 

 

 

 

US $

 

US $

 

property

 

 

 

 

 

 

Non-latest property

 

 

 

 

 

 

Intangible assets

 

 

6,196

 

                     6,196

 

other non-latest property

 

 

21

 

23

 

total non-present belongings

 

 

6,217

 

                     6,219

 

 

 

 

 

 

 

 

existing property

 

 

 

 

 

 

pay as you go prices and different present belongings

 

 

362

 

                        318

 

cash

 

 

19,805

 

                   22,651

 

complete current belongings

 

 

20,167

 

                   22,969

 

 

 

 

 

 

 

 

complete property

 

 

26,384

 

                   29,188

 

 

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

 

Non-existing liabilities

 

 

 

 

 

 

term mortgage, net of deferred financing expenses

7

 

14,255

 

14,057

 

other non-latest liabilities

7

 

109

 

23

 

complete non-present liabilities

 

 

14,364

 

14,080

 

 

 

 

 

 

 

 

current liabilities

 

 

 

 

 

 

exchange and different payables

6

 

7,204

 

                   10,890

 

derivative liability

8

 

eight,169

 

                   12,626

 

Payable on completion of scientific trial

 

 

-

 

                        500

 

total latest liabilities

 

 

15,373

 

                   24,016

 

 

 

 

 

 

 

 

complete liabilities

 

 

29,737

 

                   38,096

 

 

 

 

 

 

 

 

internet liabilities

 

 

(3,353)

 

                   (eight,908)

 

 

 

 

 

 

 

 

fairness

 

 

 

 

 

 

Share capital

9

 

four,032

 

                     3,589

 

Share top class

9

 

93,456

 

                   80,873

 

neighborhood reorganization reserve

9

 

9,938

 

                     9,938

 

accrued deficit

9

 

(a hundred and ten,779)

 

               (103,308)

 

 

 

 

 

 

 

 

complete equity

 

 

(3,353)

 

                   (8,908)

 

 

 

 

 

 

 

                    The accompanying footnotes are an integral part of those condensed consolidated meantime financial statements.  

Motif Bio plc

Unaudited meantime condensed consolidated statements of alterations in equity

For the six months ended June 30, 2018 and 2017

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

group

 

 

 

 

 

Share

 

Share

 

reorganization

 

accrued

 

 

 

capital

 

premium

 

reserve

 

deficit

 

complete

 

US $

 

US $

 

US $

 

US $

 

US $

 

 

 

 

 

 

 

 

 

 

balance at December 31, 2016

2,728

 

57,349

 

    9,938

 

   (60,206)

 

   9,809

 

 

 

 

 

 

 

 

 

 

Loss for the length

-

 

-

 

-

 

(29,713)

 

(29,713)

complete finished loss for the length

-

 

-

 

-

 

(29,713)

 

(29,713)

subject of share capital

    847

 

24,570

 

                       -  

 

                   -

 

25,417

can charge of issuance

-

 

(1,735)

 

-

 

-

 

(1,735)

endeavor of share options and warrants

9

 

414

 

-

 

-

 

423

Share-primarily based payments

                -  

 

                -  

 

                      -  

 

1,321

 

1,321

 

 

 

 

 

 

 

 

 

 

balance at June 30, 2017

 3,584

 

eighty,598

 

     9,938

 

  (88,598)

 

     5,522

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

steadiness at December 31, 2017

3,589

 

eighty,873 

 

9,938 

 

 (103,308) 

 

(8,908) 

 

 

 

 

 

 

 

 

 

 

Loss for the period

-

 

-

 

-

 

(7,777)

 

(7,777) 

complete complete loss for the duration

-

 

-

 

-

 

(7,777) 

 

(7,777) 

concern of share capital

433

 

12,989

 

-

 

-

 

13,422

charge of issuance

-

 

(749)

 

-

 

-

 

(749)

undertaking of share alternate options and warrants

10

 

343

 

-

 

-

 

353

Share-primarily based funds

-                

 

-                    

 

-                        

 

306

 

306

 

 

 

 

 

 

 

 

 

 

balance at June 30, 2018

4,032

 

ninety three,456

 

9,938

 

(a hundred and ten,779)

 

(3,353)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                          The accompanying footnotes are an essential component of these condensed consolidated meantime fiscal statements.  

Motif Bio plc

Unaudited interim condensed consolidated statements of cash flows

For the six months June 30, 2018 and 2017

(in hundreds)

 

 

 

 

 

 

 

 

 

 

 

 

 

Six months ended

 

June 30,

 

2018

 

2017

 

US $

 

US $

working activities

 

 

 

working loss for the period

(eleven,015)

 

(28,222)

changes to reconcile internet loss to internet money used in activities:

 

 

 

   Share-based mostly funds

306

 

1,321

   interest receivable

9

 

                 -

   adjustments in working belongings and liabilities:

 

 

 

      pay as you go charges and different latest property

(45)

 

                 (sixteen)

      change and different payables

(4,127)

 

            10,431

 

 

 

 

web cash utilized in operating activities

(14,872)

 

(sixteen,486)

 

 

 

 

 

 

 

 

Financing activities

 

 

 

Proceeds from situation of share capital

13,422

 

25,417

costs of issuance of share capital

(749)

 

(1,547)

Proceeds from recreation of warrants and alternatives

one hundred forty five

 

254

activity paid

(770)

 

                     -

 

 

 

 

net cash offered with the aid of financing actions

12,048

 

                24,124

 

 

 

 

web trade in cash

(2,824)

 

           7,638

cash starting of the length

22,651

 

          21,830

effect of international exchange fee alterations

(22)

 

              34

 

 

 

 

cash, end of the length

19,805

 

          29,502

 

 

 

 

 

 

 

 

  The accompanying footnotes are an integral part of these condensed consolidated meantime fiscal statements.            

 

1.     customary advice and foundation of instruction

 

These unaudited meantime condensed consolidated monetary statements for the six months ended June 30, 2018 together with the notes thereto (the "Unaudited interim Condensed Consolidated monetary Statements") of Motif Bio plc (the "business" and along with its subsidiary, Motif BioSciences Inc.  the "group") have been prepared based on overseas monetary Reporting necessities ("IFRS") as issued by means of the foreign Accounting requisites Board ("IASB") and as adopted by using the european Union. As approved by way of overseas Accounting typical 34 - "intervening time financial reporting" ("IAS 34"), the Unaudited period in-between Condensed Consolidated fiscal Statements do not consist of all disclosures required for a full presentation and do not represent statutory fiscal statements. The Unaudited period in-between Condensed Consolidated fiscal Statements may still be examine at the side of the Motif Bio plc Annual Consolidated monetary Statements for the years ended December 31, 2017, 2016 and 2015, which were organized according to IFRS as issued by using IASB and in conformity with IFRS as adopted with the aid of the european Union. The Unaudited intervening time Condensed Consolidated financial Statements had been approved for issuance by the Board of administrators on September 24, 2018.

 

The preparation of monetary statements in conformity with IFRS requires using estimates and assumptions that have an effect on the suggested quantities of belongings and liabilities at the date of the monetary tips and the mentioned quantities of income and costs during the length. despite the fact these estimates are according to administration's choicest abilities of the amount, event or moves, actual results in the end can also vary from those estimates. Reference should be made to the section "crucial Accounting guidelines and important Judgments and Estimates" in the Annual Consolidated monetary Statements for the years ended December 31, 2017, 2016 and 2015 for a detailed description of the accounting policies and more large estimates and judgments used through the neighborhood.  The accounting guidelines adopted in the instruction of those fiscal statements are in line with those offered within the community's 2017 Annual Consolidated financial Statements.

 

gadgets covered within the financial statements of each of the neighborhood's entities are measured the use of the forex of the simple financial environment wherein the entity operates ("the useful currency"). The Unaudited interim Condensed Consolidated economic Statements are presented in united states bucks (US $), which is Motif Bio plc's functional and presentation foreign money. although, all the way through the reporting duration the enterprise had exposure to Sterling. international currency transactions are translated into the useful currency the use of the trade quotes at the dates of the transactions. foreign change good points and losses as a result of the settlement of such transactions and from the interpretation of monetary assets and liabilities denominated in foreign currency at duration conclusion exchange prices are often diagnosed in profit or loss.

 

The unaudited period in-between condensed consolidated remark of comprehensive loss for the six months ended June 30, 2017 includes a US$0.2 million reclassification from research and development to common and administrative expense. This reclassification had no impact on the mentioned working effects and cash flows for the duration. The unaudited intervening time condensed consolidated remark of cash flows for the six months ended June 30, 2017 had been adjusted to present the proceeds from issuance of share capital in accordance with IAS 7.  The adjustment didn't have an have an impact on on the net cash provided by way of financing actions.

 

Going concern

 

As of June 30, 2018, the neighborhood had US$19.8 million in cash. web money utilized in working actions changed into US$14.8 million for the six months ended June 30, 2018. net loss for the six months ended June 30, 2018 became US$7.8 million. The group expects to incur losses for the immediate future as it prepares for commercialization and to the extent it advances additional analysis, development and medical trials of iclaprim. The community is unable to predict the extent of any future losses or when the group will become ecocnomic, if in any respect.

 

The Hercules mortgage agreement (word 7) topics the community to numerous affirmative and restrictive covenants, including, but now not restricted to, economic reporting duties, and certain limitations on indebtedness and liens.  Compliance with these covenants can also limit the community's flexibility in operating its enterprise. moreover, there are circumstances where the loan may well be accelerated if the community doesn't keep compliance with covenants or incurs other adventure of default beneath the Hercules personal loan contract.

 

The neighborhood could be required to lift further capital in the subsequent year to continue the development and commercialization of existing product candidates and to proceed to fund operations at the current cash expenditure ranges. The group cannot be sure that extra funding may be attainable on proper phrases, or in any respect. To the extent that the group raises further dollars by way of issuing fairness securities, its stockholders may experience tremendous dilution. Any debt financing, if obtainable, may additionally involve restrictive covenants that affect the neighborhood's potential to conduct business. If the community is unable to elevate further capital when required or on suited phrases, it might probably have to (i) drastically extend, scale back or discontinue the building and/or commercialization of one or greater product candidates; (ii) are seeking for collaborators for product candidates at an past stage than otherwise can be eye-catching and on terms that are much less favorable than might in any other case be obtainable; or (iii) relinquish or otherwise eliminate rights to applied sciences, product candidates or items that the community would in any other case are trying to find to enhance or commercialize itself on unfavorable terms. 

 

On August eight, 2018, the community introduced the receipt of a observe of Allowance from the U.S. Patent and Trademark workplace for u.s. Patent software Nos. 15/586,021 and 15/586,815 for the use iclaprim. the two system of use patents will expire in November 2037. On August 14, 2018, the neighborhood announced the FDA's acceptance of its NDA submission for iclaprim in patients with ABSSSI. The PDUFA, or Prescription Drug consumer fee Act, date is set for February 13, 2019. The group believes that these could give the groundwork for improved investor pastime within the neighborhood and, therefore, probably supply stronger alternatives to carry additional capital.

 

These fiscal statements had been organized beneath the assumption that the neighborhood will proceed as a going subject. because of the group's habitual and expected carrying on with losses from operations, the neighborhood has concluded there's colossal doubt in the group's means to proceed as a going subject inside three hundred and sixty five days of the issuance of these fiscal statements without additional capital fitting obtainable. The monetary statements don't consist of any adjustments that may result from the outcome of this uncertainty.

 

section guidance

 

the executive operating decision-maker is considered to be the Board of directors of Motif Bio plc.  the executive operating determination-maker allocates materials and assesses efficiency of the business and other activities at the operating segment level.  furthermore, they evaluation the IFRS consolidated financial statements.

 

the chief working determination-maker has decided that the group has one operating section - the building and commercialization of pharmaceutical formulations.  however the group has some activities within the U.okay., the finance and most administration functions take location in the U.S.

 

fair cost disclosures

 

The group's cash, pay as you go charges and different existing belongings and exchange and different payables are pointed out at their respective old carrying amounts, which approximates reasonable cost as a result of their short-time period nature. The group's by-product legal responsibility is measured at fair price the usage of level 1 and a couple of inputs. See discussion in word 8 on the inputs utilized within the Black-Scholes choice pricing mannequin and for a rollforward of the spinoff liability from December 31, 2017 to June 30, 2018. The community determined that the ebook value of the Hercules mortgage agreement (notice 7) approximates its fair cost as of June 30, 2018 as a result of the activity being tied to the U.S. top rate. there have been no transfers between fair cost levels throughout the six months ended June 30, 2018 or 2017.

 

When measuring the fair cost of an asset or a liability, the group makes use of observable market facts so far as viable.  reasonable values are categorized into distinct degrees in a good cost hierarchy in response to the inputs used in the valuation strategies as follows:

 

·      level 1:  quoted fees (unadjusted) in active markets for similar assets or liabilities.

·      level 2:  inputs other than quoted prices covered in degree 1 which are observable for the asset or legal responsibility, both directly (i.e. as fees) or indirectly (i.e. derived from costs).

·      stage 3:  inputs for the asset or liability that aren't in response to observable market data (unobservable inputs).

 

 

 

 

2.     Breakdown of prices with the aid of nature

 

 

Six months ended

 

 

June 30, 2018

 

June 30, 2017

(in hundreds)

 

US $

 

US $

customary and administrative

 

 

 

 

employee compensation, merits and share-based payments...............

 

1,522

 

     1,774

Director, legal and knowledgeable ...................................................................

 

1,346

 

1,763

Investor and public family members advisory costs................................................

 

641

 

  558

different fees................................................................................................

 

629

 

     526

 

 

four,138

 

  four,621

 

analysis and construction.............................................................................

 

6,877

 

23,601

  three.     Finance profits and costs

 

 

Six months ended

 

 

June 30, 2018

 

June 30, 2017

(in heaps)

 

US $

 

US $

Finance income

 

 

 

 

hobby from financial assets..........................................................................

 

9

 

       52

 

 

9

 

52

Finance charges

 

 

 

 

interest cost................................................................................................

 

(771

)

 -

Accretion of end of term charge.................................................................

 

(86

)

-

Amortization of deferred financing costs.....................................................

 

(198

)

-

 

 

(1,055

)

      -

web finance charges..............................................................................................

 

(1,046

)

fifty two

  4.    earnings tax fee   The group has recorded a loss for the six months ended June 30, 2018 and for all durations introduced. The community does not are expecting to have a cloth tax responsibility.   5.    Loss per share

 

simple loss per share is calculated by means of dividing the loss because of fairness holders of the neighborhood through the weighted usual number of shares in problem all through the year.  Diluted EPS is computed with the aid of dividing net salary (loss) by means of the weighted common of all potentially diluted share of normal stock that have been fabulous during the intervals introduced.

 

The treasury inventory system is used within the calculation of diluted EPS for probably dilutive legal responsibility categorized alternatives and warrants, which assumes that any proceeds acquired from the recreation of in-the-money alternate options and warrants, could be used to buy regular shares at the typical market costs for the period.

 

 

Six months ended

(in lots, apart from share and per share facts)

 

June 30, 2018

US $

 

June 30, 2017

US $

basic

 

 

 

 

 

 

 

 

 

internet loss...................................................................................................

 

(7,777)

 

  (29,713)

 

 

 

 

 

primary weighted commonplace shares in concern.............................................

 

272,199,780

 

 199,299,910

primary loss per share...............................................................................

 

(0.03)

 

(0.15)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted

 

 

 

 

internet loss...................................................................................................

 

(7,777)

 

  (29,713)

effect of dilutive securities: legal responsibility-categorized warrants.................

 

(4,360)

 

 -

Diluted net loss......................................................................................

 

(12,137)

 

  (29,713)

 

 

 

 

 

Weighted common shares in concern - fundamental.........................................

 

272,199,780

 

 199,299,910

Incremental dilutive shares from liability-labeled warrants (treasury inventory method)...................................................................

 

5,386,508

 

 -

Weighted standard shares in problem - diluted......................................

 

277,586,288

 

  199,299,910

Diluted loss per share...........................................................................

 

(0.04)

 

  (0.15)

 

right here doubtlessly dilutive securities surprising at June 30, 2018 and 2017 were excluded from the computation of diluted weighted general shares astounding, as they might be antidilutive.

 

 

 

Six month ended

 

 

 

2018

 

2017

 

Warrants................................................................................................

 

11,409,904

 

    forty seven,537,905

 

Share options........................................................................................

 

19,189,798

 

    18,398,299

 

 

 

30,599,703

 

  65,936,204

 

 

6.     change and other payables

(in thousands)

 

At June 30, 2018

US $

 

At December 31, 2017

US $

 

trade payables (1)..................................................................................

 

three,492

 

6,464

 

accrued prices - Contract research company......................

 

118

 

            1,293

 

accumulated expenses - other (2)..............................................................

 

three,594

 

three,009

 

different Payable........................................................................................

 

-

 

                          124

 

 

 

7,204

 

               10,890

 

 

(1) alternate payables at June 30, 2018 and December 31, 2017 include $2.3 million and $5.7 million, respectively, billed with the aid of the group's contract analysis corporation.

(2) gathered charges at June 30, 2018 and December 31, 2017 encompass $2.3 million and $1.three million, respectively, owed to the community's organisation of lively pharmaceutical ingredient.

 

 

7.     hobby bearing loans and borrowings

 

(in thousands)

Non-existing liabilities

 

At June 30, 2018

US $

 

At December 31, 2017

US $

 

term personal loan..............................................................................................

 

15,000

 

                   15,000

 

Deferred financing expenses.....................................................................

 

(745)

 

          (943)

 

 

 

14,255

 

                   14,057

 

 

On November 15, 2017, the neighborhood entered into a credit score agreement (the "Hercules loan agreement") for up to $20 million in debt financing with Hercules Capital, Inc. ("Hercules"). Pursuant to the credit contract, Hercules agreed to personal loan the neighborhood $20.0 million in two tranches. the primary tranche of $15.0 million turned into drawn down at closing, with the last $5.0 million available upon the success of definite milestones predicted in 2019, or at Hercules's discretion.

These milestones consist of (i) (x) the FDA has authorized the brand new Drug utility for marketing approval with recognize to "Iclaprim" product for the medication of patients with acute bacterial skin and epidermis constitution an infection ("ABSSSI") and (y) enrollment of first affected person in its phase 3 clinical analyze of "Iclaprim" product for the medicine of health facility-acquired bacterial pneumonia ("HABP"), (ii) market approval acquire from the FDA with respect to "Iclaprim" product for the medicine of sufferers with ABSSSI, or (iii) on the discretion of Hercules. 

The phrases encompass an initial pastime-only length of 15 months, extendable to 21 months on the success of certain milestones; a 30-month capital and hobby reimbursement period thereafter; an interest fee tied to the USA best cost, at the moment 10.5% as of June 30, 2018, and ordinary security over all property of the community, other than highbrow property where there is a bad pledge. additionally, there is a payment of US$0.4 million due on the conclusion of the term of the personal loan. beneath the credit agreement, the community issued Hercules warrants to buy up to seventy three,452 of its ads (every representing 20 typical shares) at an exercise price of US$9.fifty three per advertisements, representing three.5% warrant coverage of the total loan facility. Hercules also has the correct, in its discretion, to participate in any subsequent financing, similar to an fairness offering, in an volume as much as US$1 million. In reference to the Hercules personal loan contract closing, the neighborhood incurred US$0.5 million in costs and issued warrants with a fair cost of about US$0.4 million. each gadgets are labeled as a direct reduction from the Hercules loan contract steadiness and may be amortized over the life of the personal loan the use of the advantageous interest rate system. The neighborhood is additionally subject to an conclusion of time period can charge equal to 2.15% of the full personal loan means.  The conclusion of time period cost is payable upon loan maturity or the date that the neighborhood prepays the brilliant personal loan steadiness. For the six months ended June 30, 2018, the group diagnosed complete pastime rate of US$1.1 million, created from interest fee of US$0.8 million, accretion cost related to the conclusion-of-time period price of US$0.1 million and amortization rate related to the deferred financing costs of US$0.2 million.

8.     Warrants   Warrant undertaking   The company has issued warrants for features carried out and at the side of a variety of equity financings. The business's warrants have either a Sterling or US greenback activity cost. here is a summary of the enterprise's warrant undertaking all over the six months ended June 30, 2018:

 

 

 

number of Warrants

 

 

Weighted common

exercise price

 

 

 

 

common shares

 

 

adverts (three)

 

 

typical shares

 

 

advertisements

 

unbelievable as of January 1, 2018

 

 

22,672,867

 

 

 

1,336,354

 

 

£

0.272

 

 

$

eight.08

 

 

Granted

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

Exercised

 

 

(757,315)

 

 

 

-

 

 

£

0.246

 

 

 

-

 

 

wonderful as of June 30, 2018

 

 

21,915,552

 

 

 

1,336,354

 

 

£

0.273

 

 

$

8.08

 

 

                                                       

 

 

The company's warrants mind-blowing and exercisable as of June 30, 2018 were as follows:

 

 

type of Warrant astounding

quantity awesome and Exercisable

 

endeavor price

 

Expiration Date

 

common shares (1)

1,367,089

 

GBP £

0.20

 

April 2, 2020

 

commonplace shares (1)

1,082,384

 

GBP £

0.50

 

July 21, 2020

 

typical shares (2)

10,505,648

 

GBP £

0.322

 

November 23, 2021

 

ads (2) (three)

1,202,902

 

US $

8.03

 

November 23, 2021

 

ordinary shares (1)

8,960,431

 

GBP £

0.20

 

April 2, 2025

 

ads (2) (3) (4)

10,000

 

US $

7.26

 

July 31, 2022

 

advertisements (2) (three)

73,452

 

US $

9.53

 

November 14, 2022

 

 

(4)       Warrant provides for purchase up to 60,000 ADSs, of which 10,000 ADSs had been vested and exercisable as of June 30, 2018.

  liability categorised warrants  

advertisements warrants

On November 23, 2016, the neighborhood closed an preliminary U.S. public offering of 2,438,491 adverts and 1,219,246 advertisements warrants at a price of US $6.ninety eight per adverts/warrant combination. each ads represents 20 typical shares. The warrants have an activity fee of US$eight.03 per advertisements and expire on November 23, 2021.  in the experience the neighborhood fails to maintain the effectiveness of its Registration statement and a Restrictive Legend experience has befell, the warrant shall best be exercisable on a cashless basis. this could influence in variability within the variety of shares issued and therefore, the warrants have been specific as a fiscal liability carried at fair cost via income and loss. On issuance of the adverts warrants, the group recorded a by-product legal responsibility of US$three.8 million the use of the Black-Scholes model. The neighborhood develops its own assumptions for use within the Black-Scholes option pricing model that have observable inputs and obtainable market facts to support the reasonable cost. This components of valuation includes the use of inputs such as the fair price of the neighborhood's typical stock, inventory expense volatility of related agencies, the contractual term of the warrants, risk free pastime prices and dividend yields. The group has a constrained trading historical past in its regular stock, therefore, expected volatility is in line with that of reasonably identical publicly traded companies. due to the nature of those inputs, the valuation of the warrants is regarded stage 1 and a couple of measurements.

 

On August 1, 2017, the group issued to a 3rd birthday celebration a warrant to buy up to 60,000 ADSs at an exercise expense of US$7.26 per adverts. The warrant vested 5,000 ADSs at issuance, with the final 55,000 advertisements vesting upon pride of a number of performance conditions related to the group's stock expense and buying and selling volumes. a total of 10,000 ADSs have been vested as of June 30, 2018.  once vested, the warrant may well be exercised on a cashless foundation and expires on July 31, 2022. Exercising on a cashless foundation would outcomes in variability within the variety of shares issued and for this reason, the warrants were exact as a fiscal liability carried at reasonable price through income and loss. On issuance of the ads warrants, the group recorded a by-product legal responsibility of US$0.1 million the usage of the Black-Scholes mannequin.

 

On November 14, 2017, at the side of the Hercules personal loan agreement, the community issued Hercules a warrant to purchase as much as seventy three,452 ADSs at an activity cost of US$9.fifty three per advertisements, representing three.5% warrant coverage of the full loan facility. The warrant may be exercised on a cashless basis, and is instantly exercisable through November 14, 2022. Exercising on a cashless foundation would effect in variability within the variety of shares issued and for this reason, the warrants had been targeted as a financial legal responsibility carried at fair cost via income and loss. On issuance of the adverts warrants, the community recorded a spinoff liability of US$0.4 million the use of the Black-Scholes mannequin. 

 

At June 30, 2018 and December 31, 2017, the liability categorised advertisements warrants had a good value of US$5.6 million and US$8.9 million the use of right here weighted-regular assumptions in the Black-Scholes mannequin:

 

 

June 30,

2018

 

December 31,2017

 

 

 

 

Share rate (US $)...........................................................................................

eight.20

 

10.eighty one

activity cost (US $).......................................................................................

eight.08

 

8.08

anticipated volatility............................................................................................

73 %

 

76 %

number of durations to endeavor.........................................................................

three.47

 

three.97

risk free fee....................................................................................................

2.sixty eight %

 

2.10 %

anticipated dividends..........................................................................................

-

 

-

 

ordinary warrants

On November 23, 2016, the group placed 22,863,428 average shares along with eleven,431,714 warrants over commonplace shares at a value of 28 pence per share/warrant aggregate. The warrants have an endeavor expense of £0.322 per warrant and expire on November 23, 2021. in the event that the group fails to keep the effectiveness of the Registration observation, the warrant shall simplest be exercisable on a cashless foundation.  this would influence in variability within the variety of shares issued and hence, the warrants were targeted as a economic legal responsibility carried at reasonable cost through income and loss. On issuance of the warrants, the community recorded a derivative liability of US$1.8 million the usage of the Black-Scholes model. 

 

At June 30, 2018 and December 31, 2017, the liability categorised common warrants had a fair cost of US$2.5 million and US$three.7 million the usage of the Black-Scholes model and the following assumptions:

 

 

June 30,2018

 

December 31,2017

 

 

 

 

 

 

Share expense (GBP)............................................................................................

0.34

 

0.forty one

 

recreation price (GBP)........................................................................................

0.322

 

0.322

 

anticipated volatility............................................................................................

73 %

 

76 %

 

number of intervals to undertaking.........................................................................

3.40

 

3.90

 

chance free expense....................................................................................................

2.63 %

 

2.09 %

 

anticipated dividends...........................................................................................

-

 

-

 

 

 

right here is a summary of the neighborhood's legal responsibility classified warrant undertaking, including each advertisements and usual warrants, all the way through the six months ended June 30, 2018:

 

 

 

fair cost

(in heaps)

liability classified warrants

 

 

US $

stability at December 31, 2017.........................................................................

 

 

12,626

Issued right through the period.................................................................................

 

 

-

Exercised all through the length............................................................................

 

 

(eighty three)

have an impact on of international change.............................................................................

 

 

(14)

gain from revaluation of by-product liabilities...............................................

 

 

(four,360)

balance at June 30, 2018...............................................................................

 

 

 eight,169

 

 

9.      Share capital  

allotted, referred to as up and wholly paid:

 

number

 

US $

(in lots, except share records)

 

 

 

 

 

In concern at December 31, 2017..............................................................................................

 

263,519,128

 

three,589

 

 

 

 

 

     Issued:

 

 

 

 

common shares of 1p each.........................................................................................

 

757,315

 

9

common shares of 1p each.........................................................................................

 

32,258,064

 

433

general shares of 1p each.........................................................................................

 

a hundred twenty five,736

 

1

 

 

 

 

 

In problem at June 30, 2018.......................................................................................................

 

296,660,243

 

four,032

  throughout January via June of 2018, 757,315 usual shares have been issued upon the exercise of warrants.   On may additionally 17, 2018, the community placed 32,258,064 new standard shares at 31 pence per share and bought US$12.7 million of internet proceeds.   In June 2018, a hundred twenty five,736 ordinary shares had been issued upon the endeavor of a inventory choice.   Share top class represents the extra over nominal price of the reasonable price consideration got for equity shares, net of fees of the percentage situation. Retained deficit represents amassed losses.   The neighborhood reorganization reserve arose in March 2015 when Motif Bio plc grew to become the dad or mum of the community. This become a common control transaction and therefore outside the scope of IFRS three- "enterprise combinations." The transaction has therefore been accounted for as a group reorganization and the group is offered as if the enterprise has always owned Motif BioSciences Inc. The reserve on consolidation represents the change between the nominal value of the shares of the enterprise issued to the former stockholders of Motif BioSciences Inc. and the percentage capital and share top class of Motif BioSciences Inc. on the date of the transaction. As cited, the nominal price of the enterprise shares was used in the calculation of the reorganization reserve.

 

10.    Share-based payments

 

On December four, 2014, Motif BioSciences Inc. adopted a Share option Plan (the "Plan") beneath which alternatives may also be granted to employees, consultants, and directors. the share expense used for the Plan previous to being traded on aim became in accordance with administration's assessment of the valuation of the community given the internet assets and future capabilities of the group at the time of granting.

 

Motif Bio plc adopted a Share option Plan (the "New Plan") on April 1, 2015. the brand new Plan replaces Motif BioSciences Inc.'s outdated share plan.  there were no adjustments to the fair cost of share alternatives granted below the Plan with the most effective trade being to grant the holders shares in Motif Bio plc rather than Motif BioSciences Inc. upon exercising options. The endeavor price for every alternative should be dependent on the discretion of the Board provided that the recreation cost for each alternative shall now not be lower than the nominal price of the valuable shares if the options are to be satisfied via a new concern of shares by using the company and on condition that the endeavor rate per share for an option shall not be under the fair market value of a share on the effective date of grant of the alternative. alternate options should be exercisable at such instances or upon such movements and area to such terms, conditions and restrictions as decided with the aid of the Board on supply date. besides the fact that children, no option will likely be exercisable after the expiration of ten years after the constructive date of supply of the option.

 

 

right here is a abstract of the neighborhood's alternative recreation for the six months ending June 30, 2018.

 

 

 

 

 

Weighted usual

 

 

 

quantity of

 

activity expense

 

 

 

share options

 

US $

 

 

 

 

 

 

 

wonderful at December 31, 2017..................................................................

 

17,065,534

 

0.32

 

Granted throughout the period...................................................................................

 

5,050,000

 

0.forty nine

 

Forfeited throughout the period.................................................................................

 

 (2,593,750)

 

0.36

 

Cancelled right through the duration ...............................................................................

 

 (206,250)

 

0.forty nine

 

Exercised all over the duration ................................................................................

 

(125,736)

 

0.14

 

Expired throughout the length...................................................................................

 

-

 

-

 

fantastic at June 30, 2018...........................................................................

 

19,189,798

 

0.35

 

 

 

 

 

 

 

Exercisable at June 30, 2018............................................................................

 

eleven,833,220

 

0.29

 

 

 

the whole expense diagnosed for the periods bobbing up from stock-primarily based payments are as follows:

 

 

 

Six months ended

 

 

 

June 30, 2018

 

June 30, 2017

 

 

 

US $

 

US $

 

 

 

 

 

 

 

usual and administrative rate......................................................

 

250

 

824

 

research and development fee......................................................

 

fifty six

 

497

 

complete share-based mostly payment expense......................................................

 

306

 

1,321

 

 

The intervening time financial statements for the six months ended June 30, 2017 consist of a cumulative adjustment of US$1.1 million for the correction of a previous length error. inventory-based mostly compensation price became understated basically as a result of recognizing expense handiest when an award vested, not over the required service length the use of a graded vesting method as required beneath IFRS 2. The neighborhood up to now assessed the materiality of the out-of-period adjustment on all impacted periods and concluded that the cumulative adjustment to suitable the error may still be recorded within the six months ended June 30, 2017. This adjustment didn't have an impact on the money materials of the community.   11. employee charges

 

The combination payroll prices of executive directors and key management personnel were as follows:

 

 

 

Six months ended

 

 

 

June 30, 2018

 

June 30, 2017

 

 

 

US $

 

US $

 

 

 

 

 

 

 

Wages and salaries..........................................................................................

 

1,646

 

1,278

 

Social security and other company expenses.......................................................

 

158

 

139

 

Share base funds(1)...................................................................................

 

683

 

733

 

 

 

2,487

 

2,a hundred and fifty

 

  (1)  the total share based payments doesn't replicate the up to now disclosed out-of-period adjustment in 2017 and any forfeitures or cancellations of option awards (note 10).

 

12. linked birthday party transactions

 

Transactions with Amphion improvements plc and Amphion innovations US, Inc.

 

At June 30, 2018, Amphion innovations plc owned 9.5% of the issued regular shares in Motif Bio plc. Richard Morgan and Robert Bertoldi were administrators of each the business and Amphion improvements plc in the period. Transactions between the community and the Amphion community are disclosed below:

 

Advisory and Consultancy agreement with Amphion improvements US, Inc. and Shared office house

 

On April 1, 2015, the neighborhood entered into an Advisory and Consultancy agreement with Amphion improvements US, Inc. the respect for the services to be offered is US$120,000 every year. The contract was amended in December 2016 in order that either celebration may additionally terminate the agreement at any time, for any cause, upon giving the other birthday celebration 90-days develop written word.  The group paid US$60,000 and US$60,000 to Amphion improvements US, Inc. all over the six months ended June 30, 2018 and 2017, respectively, in line with the phrases of the contract. As of the date of this intervening time document, the settlement remains in force.

 

Consultancy settlement with Amphion innovations plc

 

On April 1, 2015, the community entered into a Consultancy contract with Amphion innovations plc for the services of Robert Bertoldi, an employee of Amphion improvements plc. the glory for his services turned into US$5,000 monthly. On November 1, 2015, the honor become accelerated to US$a hundred and eighty,000 once a year. On July 1, 2016, the distinction diminished to US$seventy five,000 once a year. The settlement changed into for an preliminary duration of 12 months and would instantly renew each yr on the anniversary date except either birthday party notifies the different via giving ninety-days written word prior to expiration. The agreement was amended in December 2016 in order that both birthday celebration can also terminate the settlement at any time, for any purpose, upon giving the different birthday party 90-days advance written notice.  In July 2017, the group amended the consulting settlement with Amphion innovations plc to increase the annual consideration to US$a hundred twenty five,000 to more desirable mirror Robert Bertoldi's time commitment to the group with an exceptional date of January 1, 2017.  The group paid Robert Bertoldi US$62,500 and US$37,500 all the way through the six months ended June 30, 2018 and 2017, respectively, based on the phrases of the settlement.

 

Consultancy agreement with Amphion improvements US, Inc.

 

On September 7, 2016, the community entered right into a Consultancy contract with Amphion innovations US, Inc., pursuant to which Amphion improvements US, Inc. will give consultancy functions on the subject of the community's responsibilities as a NASDAQ listed business. the respect for the features is $15,500 per thirty days. The contract is for an initial period of 12 months, after which the settlement terminated. The group paid US$ninety three,000 right through the six months ended June 30, 2017 pursuant to the phrases of this contract.

 

Consultancy contract with Jonathan Gold

  

On April 7, 2017, the neighborhood entered right into a consultancy contract with Jonathan Gold, a member of the community's Board of administrators. under the terms of this contract, Mr. Gold received a fixed charge of US$sixteen,167 per month for strategic financial knowledgeable information and tips. The time period of this contract was twelve months, starting off January 1, 2017. The term of the settlement would immediately renew each month following the preliminary term, so long as either birthday party didn't supply notice to the other celebration of its election not to proceed to renew the agreement with at least 30-days boost observe. This settlement was suspended as of December 31, 2017. effective February 2, 2018, Mr. Gold assumed the government function of Chief financial Officer upon the resignation of Robert Dickey IV, the neighborhood's former Chief monetary Officer.

  13. Subsequent events

 

beneficial July sixteen, 2018, Robert Bertoldi voluntary resigned from the Board of directors.  Robert Bertoldi continues to give consultancy functions to Motif Bio under the phrases of the consultancy contract with Amphion innovations plc.

This tips is provided by RNS, the news service of the London stock exchange. RNS is approved by means of the fiscal behavior Authority to behave as a primary tips issuer in the uk. terms and stipulations regarding the use and distribution of this suggestions may follow. For additional tips, please contact [email protected] or visit www.rns.com. end IR EAANLAEEPEAF
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