Corporate Update & Proposed Fundraising

RNS Number : 7183X

Futura Medical PLC

20 December 2019

 

20 December 2019

THIS ANNOUNCEMENT, INCLUDING THE APPENDIX, AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, AUSTRALIA, THE REPUBLIC OF IRELAND, NEW ZEALAND OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION.

THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FUTURA MEDICAL PLC OR ANY OTHER ENTITY IN ANY JURISDICTION. NEITHER THIS ANNOUNCEMENT NOR THE FACT OF ITS DISTRIBUTION, SHALL FORM THE BASIS OF, OR BE RELIED ON IN CONNECTION WITH ANY INVESTMENT DECISION IN RESPECT OF FUTURA MEDICAL PLC.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF EU REGULATION 596/2014 ("MAR").

UNLESS OTHERWISE INDICATED, CAPITALISED TERMS IN THIS ANNOUNCEMENT HAVE THE MEANING GIVEN TO THEM IN THE DEFINITIONS SECTION INCLUDED IN THE APPENDIX.

Futura Medical plc

("Futura" or "the Company")

Corporate Update & Proposed Fundraising of £3.25 million

by way of Subscription and PrimaryBid Offer

Futura, a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal Dermasys® drug delivery technology and focused on sexual health and pain, announces a company update and proposed fundraising at a price of 8 pence per share (the "Issue Price") to raise £3.25 million (before expenses) by way of a subscription for 21,875,000 new Ordinary Shares (the "Subscription") and an offer for subscription for 18,750,000 new Ordinary Shares via PrimaryBid (the "PrimaryBid Offer") (together the "Fundraising") to fund its ongoing working capital requirements and to allow the Company to pursue a medical device regulatory pathway for DermaSys®.  The Fundraising is fully subscribed subject to clawback to meet additional demand from both new and existing investors.

Corporate Update Highlights

·      Futura's proprietary transdermal formulation DermaSys® clinically proven to treat Erectile Dysfunction

·      Futura aims to pursue medical device regulatory pathway in the US and Europe, filing by mid-2020

·      New patent application filed to extend protection until 2039, if successful

Fundraising Highlights

·      Proposed Subscription by the Company's largest shareholder, Lombard Odier for 21,875,000 new Ordinary Shares ("Investor Subscription Shares") at the Issue Price to raise gross proceeds of £1.75 million

·      PrimaryBid Offer for of 18,750,000 new Ordinary Shares ("PrimaryBid shares") to raise gross proceeds of £1.5 million, under which Lombard Odier has undertaken to subscribe for all 18,750,000 PrimaryBid Shares, such amount being subject to clawback to meet accepted applications received under the PrimaryBid Offer

·      A further announcement launching the PrimaryBid Offer will be made shortly. The PrimaryBid Offer, via the PrimaryBid.com platform, will be open to individual and institutional investors from 4.31 p.m. on Friday 20 December 2019 to 5 p.m. on Sunday 22 December 2019

·      Lombard Odier will be issued up to a maximum of 20,312,500 warrants, to subscribe for further new Ordinary Shares at a price of 40 pence per share, a 400% premium to the Issue Price, exercisable until the fifth anniversary of their issue

·      The Fundraising is conditional on Shareholder approval at a general meeting

·      A circular, which will provide further details of the Fundraising and include a notice convening the General Meeting (the "Circular") will be sent to Shareholders shortly and a further announcement will be made

·      The Issue Price represents a discount of 25.58 per cent. to the Closing Price of 10.75 pence on 19 December 2019 being the last practicable trading day prior to release of this announcement

·      The net proceeds of the Fundraising will be used to fund the Company's ongoing working capital requirements and to allow the Company to pursue a medical device regulatory pathway for DermaSys® 

A further announcement will be made with respect to the result of the Fundraising on 23 December 2019.

James Barder, Chief Executive Officer, Futura Medical said: "The study results show that our transdermal technology, DermaSys®, has proven to be highly effective across all ED patient severities and, as a result, we now plan to pursue the simpler medical device regulatory pathway for DermaSys®.

Aside from the potential opportunity represented by a fast acting clinically proven treatment for ED, we believe there is a further incremental commercial opportunity for DermaSys®, providing a clinically proven treatment to patients currently contraindicated from using existing medications such as nitrates and alpha blockers and believe DermaSys® could also be used in combination with other ED therapies such as the PDE5s.

Consultations with external and in house regulators have taken place to provide clarity on potential timing and further requirements for approval in both the EU and US.  As a consequence we have recently submitted a request to the FDA for a pre-submission meeting in Q1 2020 ahead of regulatory submission.

The medical device route is typically quicker, requires less data and is less costly than the prescription drug approval route, and we are confident that we will look to file in mid-2020 in the EU and potentially the USA as well, although this assumes no further studies being required by the FDA."

ADDITIONAL INFORMATION

Corporate Update and background to and reasons for the Fundraising

As previously announced, top line results from the MED2005 Phase 3 study (FM57) showed that all arms met all primary endpoints against baseline, showing strong efficacy, excellent safety, rapid speed of onset.  These results give us the confidence that DermaSys® has the potential to be a highly effective, clinically proven, topical treatment for erectile dysfunction.

DermaSys® Regulatory Pathway

As DermaSys® alone, without the inclusion of GTN has been shown, in the Board's view, to be a highly effective and safe treatment for ED, Futura now plans to pursue the medical device regulatory pathway for its proprietary transdermal formulation DermaSys® in the US and Europe. Classed as a medical device rather than a pharmacological treatment Futura believes this will enable DermaSys® to have the same clinically proven medical claims as a pharmaceutical drug but will result in a simpler, and potentially faster regulatory pathway for DermaSys® Initial company assessments indicate that the bar for clinical evidence may already be met; although small studies may be required, especially in the case of the USA.  These regulatory positions are the consensus from a number of regulatory experts consulted by Futura, nevertheless the Company will be meeting with respective regulators ahead of regulatory filings. Futura anticipates filing in Europe by mid-2020 and potentially a similar timing for the USA although this will depend on whether no further studies are required by US regulators.

The efficacy of the DermaSys® product has shown in the recent Phase 3 study, efficacy approaching the level of current oral first line therapies for the treatment of erectile dysfunction but with a rapid speed of onset and significantly lower adverse events. Moreover, with the lack of drug interactions with other prescription products will, we believe, enable DermaSys® to be used with other medications such as nitrates and other cardiovascular drugs. The Board believes DermaSys® represents a broader overall commercial opportunity than previously envisaged in a global market for erectile dysfunction worth in excess of $5 billion.

FM57 Top line results

Futura presented top line data from the 1,000 patient Phase 3 study (FM57) on 10 December 2019.  Results demonstrated that all four doses of MED2005 (DermaSys®, DermaSys® with 0.2% Glyceryl Trinitrate (GTN), DermaSys® with 0.4% GTN and DermaSys® with 0.6% GTN) achieved all primary endpoints when assessed against baseline, although no differences were noted between the four treatment groups. DermaSys® alone, without the inclusion of GTN, has a significant clinical effect in over 60% of patients and therefore, the Board believes, is a potent and effective treatment across the three severities of ED. Over 60% of patients also saw a speed of onset within 10 minutes of application, substantially faster than sildenafil with significant benefits for spontaneous rather than pre-planned sexual intercourse.

DermaSys® was used as the placebo arm following regulatory requirements to have a placebo as near as possible to the active product. The side-effect profile of the four different treatment doses saw an extremely low adverse event profile with the DermaSys® formulation (without GTN) and an increasing, but acceptable adverse event profile with the DermaSys® formulation with the 0.2%, 0.4% and 0.6% GTN doses respectively.  This supports the Company's strong belief that there was no formulation or administration error in the product labelling for patients and this is further endorsed by quality control checks which were carried out throughout the study on product supplied to patients.

Aside from the potential opportunity a fast acting clinically proven treatment for ED represents, the Board also believes there is a further incremental commercial opportunity for DermaSys®, providing a clinically proven treatment to patients currently contraindicated from using existing medications such as nitrates and alpha blockers and believe DermaSys® could also be used in combination with other ED therapies such as the PDE5s. The Company has filed a new patent application which has the potential, if successful, to extend protection until 2039.

DermaSys®

DermaSys® is a proprietary patented drug delivery technology platform offering clear product differentiation compared to existing marketed treatments.  It is a clear, odourless gel that provides rapid and targeted local delivery to the required site of action. 

The Board now believes that DermaSys®, when applied to the head of the penis, triggers both mechanical (massage) and physical effects whereby the evaporation of the volatile components in DermaSys create a sensory stimulation effect.

Use of proceeds of the Fundraising

The Company is proposing to raise gross proceeds of £3.25 million (net £3.0 million) from the Subscription and PrimaryBid Offer. The net proceeds (after deducting the costs and expenses of the Fundraising), along with the Company's existing cash resources, are intended to be used to fund working capital to allow the Company to pursue a medical device regulatory pathway for DermaSys®.

The Company's cash balance totalled £2.96 million as at 30 November 2019. In addition to existing cash, the net proceeds of the fundraise are expected to be utilised as follows:

·      Fund the R&D programme

o  Close out costs relating to FM57 study

o  Regulatory advisory and filings costs relating to the revised Medical Device pathway for DermaSys® as a treatment for ED

·      Group working capital

·      Ongoing costs related with patent renewals and maintenance across all product portfolio

The Board believe that further significant clinical cost will not be required in relation to EU approval based on their past experience of obtaining EU medical device approval. The Board also believes that further significant clinical cost will not be required in relation to US approval, but this cannot be confirmed until a formal meeting with the FDA has been held.  The Company believes that this meeting will be held by the end of Q1 2020. 

Should further clinical work be required before submission can be made to the appropriate regulators, the existing cash balances along with proceeds raised from the Fundraising will not be sufficient to complete this work.  In the event that further clinical work is required, the Board continues to assess non-dilutory funding options, including funding from potential commercial partners as a result of upfront licensing fees or as part of an overall out-licence agreement.

As a result of the Fundraising, and assuming receipt by the Company of its expected levels of tax credits, the Board believe that the Company will now have sufficient working capital for at least 12 months from the date of this announcement and will enable the Company to proceed with its plans to have DermaSys® approved as a medical device.

Details of the Subscription Agreement and the Investor Subscription Shares

Pursuant to a subscription agreement dated today, Lombard Odier has agreed to subscribe for 21,875,000 new Ordinary Shares at a price of 8 pence per new Ordinary Share, raising £1,750,000 before expenses. The Subscription is conditional on (amongst other things):

·      the Resolutions being passed at the General Meeting or any adjournment thereof by no later than 5:30 p.m. on 17 January 2020;

·      the warranties given under the Subscription Agreement being and remaining accurate and not misleading until Admission;

·      the Company having complied in all material respects with its obligations and having satisfied the conditions under the Subscription Agreement which are to be performed or satisfied prior to Admission; and

·      Admission taking place by no later than 8 a.m. on 20 January 2020 (or such later date as the Company may agree with Liberum).

If the conditions set out above are not satisfied or waived (where capable of waiver), the Subscription will lapse, the Investor Subscription Shares will not be issued and any monies received from the Investor in respect of the Investor Subscription shares shall be returned to the Investor.

In addition, Lombard Odier will subscribe for 18,750,000 new Ordinary Shares under the PrimaryBid Offer, which subscription shall be subject to clawback by an amount equivalent to the aggregate applications received under the PrimaryBid Offer.

Lombard Odier will receive a commitment fee and up to 20,312,500 warrants over Ordinary Shares in respect of its Subscription and participation under the PrimaryBid Offer, which can be exercised at a price of 40 pence per share until the fifth anniversary of the issue of the warrant, at a ratio of one warrant for every two shares subscribed in respect of the Investor Subscription Shares and any PrimaryBid Shares allocated to it through its participation under the PrimaryBid Offer, subject to the Company being granted sufficient headroom to issue Ordinary Shares at the forthcoming General Meeting. Full details of the terms of the warrants will be set out in the Circular.  Subject to the Resolutions being passed at the General Meeting, Lombard Odier's participation in the Subscription and under the PrimaryBid Offer, will constitute a related party transaction under Rule 13 of the AIM Rules for Companies.  Further details will be provided in the announcement of the result of the Fundraising to be issued on 23 December 2019.  

Application for admission to trading

Application will be made to the London Stock Exchange for admission of the Investor Subscription Shares and the PrimaryBid shares to trading on AIM.

It is expected that Admission will take place no later than 8 a.m. on 20 January 2020 and that dealings in the Subscription Shares and the PrimaryBid Shares on AIM will commence at the same time.

Importance of shareholder vote

Your attention is again drawn to the fact that the Fundraising is conditional and dependent upon, amongst other things, shareholders approving the resolutions at the general meeting of the Company. In the event that such conditions are not satisfied, the Fundraising will not proceed.

Shareholders are asked to vote in favour of the resolutions at the general meeting in order for the Fundraising to proceed. However, if the resolutions are not passed or another condition of the Fundraising is not satisfied for any reason, the Fundraising will not proceed and the Company would not expect to have funds immediately available to continue with its proposals as set out in this announcement, in which case, shareholders could be at risk of losing all or a substantial amount of their investment.

Expected Timetable of Principal Events

Launch of the Fundraising		4:30 p.m. on 20 December 2019
PrimaryBid Offer open from		4:31 p.m. on 20 December 2019
PrimaryBid Offer closed at		5 p.m. on 22 December 2019
Announcement of the result of the Fundraising		23 December 2019
Publication and posting of the this document and Notice of General Meeting and Form of Proxy	24 December 2019
Latest time and date for receipt of Forms of Proxy		11:00 a.m. on 15 January 2020
General Meeting		11:00 a.m. on 17 January 2020
Results of the General Meeting announced		17 January 2020
Admission of Subscription Shares and PrimaryBid Shares to trading on AIM and commencement of dealings		8 a.m. on 20 January 2020
CREST accounts to be credited for Subscription Shares to be held in uncertificated form		8 a.m. on 20 January 2020
Dispatch of definitive share certificates for Subscription Shares and  PrimaryBid Shares to be held in certificated form		by 27 January 2020

All references to time in this document are to London time, unless otherwise stated

For further information please contact:

Futura Medical plc	[phone]
James Barder, Chief Executive Officer Angela Hildreth, Finance Director & Chief Operating Officer	www.futuramedical.com
Liberum	[phone]
Nominated Adviser and Broker Bidhi Bhoma/ Euan Brown/ Kane Collings
For media enquiries please contact Optimum Strategic Communications	[phone]
Mary Clark/ Eva Haas/ Hollie Vile

Important Notice

Liberum is acting as nominated adviser and broker for and on behalf of the Company. Liberum is authorised and regulated by the Financial Conduct Authority (the "FCA") in the United Kingdom. Liberum is not acting for the Company in relation to the PrimaryBid Offer. Liberum is acting exclusively for the Company and no one else in connection with the Subscription and Liberum will not be responsible to anyone other than the Company for providing the protections afforded to its clients or for providing advice in relation to the Fundraising or any other matters referred to in this announcement.

No representation or warranty, express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by Liberum or by any of its affiliates or agents as to, or in relation to, the accuracy or completeness of this announcement or any other written or oral information made available to or publicly available to any interested party or its advisers, and any liability therefor is expressly disclaimed.

No statement in this announcement is intended to be a profit forecast or estimate, and no statement in this announcement should be interpreted to mean that earnings per share of the Company for the current or future financial years would necessarily match or exceed the historical published earnings per share of the Company.

The price of shares and any income expected from them may go down as well as up and investors may not get back the full amount invested upon disposal of the shares. Past performance is no guide to future performance, and persons needing advice should consult an independent financial adviser.

The Investor Subscription Shares and PrimaryBid Shares will not be admitted to trading on any stock exchange other than on the AIM market of the London Stock Exchange.

Neither the content of the Company's website nor any website accessible by hyperlinks on the Company's website is incorporated in, or forms part of, this announcement. 

This announcement may contain and the Company may make verbal statements containing "forward-looking statements" with respect to certain of the Company's plans and its current goals and expectations relating to its future financial condition, performance, strategic initiatives, objectives and results. Forward-looking statements sometimes use words such as "aim", "anticipate", "target", "expect", "estimate", "intend", "plan", "goal", "believe", "seek", "may", "could", "outlook" or other words of similar meaning. By their nature, all forward-looking statements involve risk and uncertainty because they relate to future events and circumstances which are beyond the control of the Company, including amongst other things, United Kingdom domestic and global economic business conditions, market-related risks such as fluctuations in interest rates and exchange rates, the policies and actions of governmental and regulatory authorities, the effect of competition, inflation, deflation, the timing effect and other uncertainties of future acquisitions or combinations within relevant industries, the effect of tax and other legislation and other regulations in the jurisdictions in which the Company and its respective affiliates operate, the effect of volatility in the equity, capital and credit markets on the Company's profitability and ability to access capital and credit, a decline in the Company's credit ratings; the effect of operational risks; and the loss of key personnel. As a result, the actual future financial condition, performance and results of the Company may differ materially from the plans, goals and expectations set forth in any forward-looking statements. Any forward-looking statements made in this announcement by or on behalf of the Company speak only as of the date they are made. Except as required by applicable law or regulation, the Company expressly disclaims any obligation or undertaking to publish any updates or revisions to any forward-looking statements contained in this announcement to reflect any changes in the Company's expectations with regard thereto or any changes in events, conditions or circumstances on which any such statement is based.

DEFINITIONS USED IN THIS ANNOUNCEMENT

"Admission"	the admission of the Investor Subscription Shares and the PrimaryBid Shares to trading on AIM becoming effective in accordance with the AIM Rules
"AIM"	the market of that name operated by the London Stock Exchange
"AIM Rules"	the AIM Rules for Companies, as published by the London Stock Exchange, as amended
"Board" or "Directors"	the board of directors of the Company
"certificated" or "in certificated form"	an Ordinary Share which is not in uncertificated form (that is, not in CREST)
"Circular"	the circular to be sent to Shareholders enclosing the notice of the General Meeting
"Closing Price" "Company" or "Futura"	the closing price of an Ordinary Share Futura Medical plc, a public limited company (incorporated and registered in England and Wales with registered number 04206001) whose registered office is at Surrey Technology Centre, 40 Occam Road, Guildford, Surry GU2 7YG
"Companies Act"	the Companies Act  2006 as amended
"CREST"	the computerised settlement system operated by Euroclear which facilitates the transferring of title to shares in uncertificated form
"Directors"	the directors of the Company
"FCA"	the Financial Conduct Authority
"Fundraising"	the Subscription and the PrimaryBid Offer
"General Meeting"	the general meeting of the Company to be held at the offices of Futura Medical plc at Surrey Technology Centre, 40 Occam Road, Guildford, Surry GU2 7YG at 11:00 a.m. on 17 January 2020, or any adjournment thereof
"Group"	the Company and its subsidiary undertakings (as defined in the Companies Act)
"Investor Subscription Shares"	new Ordinary Shares to be issued in connection with the Subscription
"Issue Price"	8 pence per Investor Subscription Share or PrimaryBid Share
"Lombard Odier" "London Stock Exchange"	Lombard Odier Asset Management (Europe) Limited  London Stock Exchange plc
"MAR"	the Market Abuse Regulation (EU/596/2014)
"Liberum"	Liberum Capital Limited (registered in England and Wales with registered number 05912554) whose registered office is at Ropemaker Place Level 12, 25 Ropemaker Street, London, EC2Y 9LY, the Company's nominated adviser and broker
"Ordinary Shares"	the ordinary shares of 0.2 pence each in the capital of the Company
"PrimaryBid"	PrimaryBid Limited (registered number 08092575), which is authorised and regulated by the FCA with register number 779021
"PrimaryBid Offer"	The PrimaryBid offer of new Ordinary Shares made to private and other investors on the PrimaryBid platform
"PrimaryBid Shares"	new Ordinary Shares to be issued in connection with the PrimaryBid Offer
"Resolutions"	the resolutions to be proposed at the General Meeting as set out in the Notice
"Shareholders"	holders from time to time of Ordinary Shares
"Subscription"	the conditional subscription of the Investor Subscription Shares at the Issue Price by certain investors
"Subscription Agreement"	the subscription agreement entered into between the Company and Lombard Odier Asset Management (Europe) Limited ("LOAME") acting in its capacity as discretionary investment manager or sub-adviser for and on behalf of certain funds and accounts managed by it and/or as agent of Lombard Odier Asset Management (USA) Corp ("LOAM USA") acting in its capacity as discretionary investment manager for and on behalf of certain funds and accounts managed by it, it being understood that LOAME and LOAM USA are acting as an agent and not as principal,  on or about the date of this announcement, pursuant to which LOAME/LOAM USA (as applicable) has agreed to subscribe for 21,875,000 Investor Subscription Shares and 18,750,000 PrimaryBid Shares on the terms and conditions set out therein
"uncertificated" or "in uncertificated form"	recorded on a register of securities maintained by Euroclear in accordance with the CREST Regulations as being in uncertificated form in CREST and title to which, by virtue of the CREST Regulations, may be transferred by means of CREST
"United Kingdom" or "UK"	the United Kingdom of Great Britain and Northern Ireland

 

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