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Section 1 – Registrant’s Business and Operations
Item 1.01 Entry into a Material Definitive Agreement
On May 2, 2014, Remmington Enterprises, Inc., a Nevada corporation (the “Company”), entered into a Share Exchange Agreement (the “Exchange Agreement”) with Mitovie Pharma Europe Ltd., a privately held company incorporated under the laws of Scotland (“Mitovie”) and the shareholders of Mitovie.
As a result of the transaction (the “Exchange”), Mitovie became a wholly-owned subsidiary of the Company. In accordance with the terms of the Exchange Agreement, at the closing an aggregate of 12,280,000 shares of the Company’s common stock were issued to the holders of Mitovie’s common stock in exchange for their shares of Mitovie. Each of the Company, Mitovie and the shareholders of Mitovie provided customary representations and warranties, pre-closing covenants and closing conditions in the Exchange Agreement.
The foregoing description of the Exchange Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Exchange Agreement, which is filed as Exhibit 2.1 to this report and incorporated herein by reference.
Section 2 – Financial Information
Item 2.01 Completion of Acquisition or Disposition of Assets
The Company completed the acquisition of Mitovie pursuant to the Exchange Agreement, under the terms of which, the shareholders of Mitovie received 12,280,000 shares of the Company’s common stock in exchange for 100% of the outstanding capital stock of Mitovie.
Pre-Exchange stockholders of Mitovie will be required to exchange their existing stock certificates for the Company’s certificates. The Company’s common stock is currently quoted on the OTCQB operated by OTC Markets Group, Inc. under the symbol RMMG.
The Exchange and its related transactions were approved by the holders of a requisite number of shares of Mitovie’s common stock.
The Exchange is being accounted for as a reverse acquisition and recapitalization. Mitovie is the acquirer for accounting purposes and the Company is the issuer. Accordingly, Mitovie’s historical financial statements for periods prior to the acquisition become those of the acquirer retroactively restated for the equivalent number of shares received in the Exchange. The accumulated deficit of Mitovie is carried forward after the acquisition. Operations prior to the Exchange are those of Mitovie. Earnings per share for the period prior to the Exchange are restated to reflect the equivalent number of shares outstanding.
Upon the closing of the Exchange, Han Morgan Van Niekerk resigned as President, Secretary, Chief Executive Officer and Chief Financial Officer of the Company and the sole director of the Company. Michael Richard Hawthorne was appointed as Chief Executive Officer and President, Lorna Peers was appointed Chief Financial Officer, Secretary and Treasurer, and Vinod Kaushal was appointed as Chairman. Simultaneous with the closing, Michael Richard Hawthorne, Lorna Peers and Vinod Kaushal were appointed as directors.
There were 15,505,000 shares of the Company’s common stock outstanding before giving effect to the stock issuances in the Exchange. Immediately following the Exchange, the Company’s majority shareholder, ES Partners, Ltd., cancelled its 12,050,000 shares. Following these transactions, there were 15,280,000 shares outstanding, including:
Shares: Held By:
12,280,000 Mitovie Shareholders
3,000,000 Existing Company Shareholders
Prior to the Exchange, there were no material relationships between the Company and Mitovie, or any of their respective affiliates, directors or officers, or any associates of their respective officers or directors, other than as disclosed in this Current Report.
The shares issued in the Exchange were not registered under the Securities Act, but were issued in reliance upon the exemption from registration provided by Regulation S of the Securities Act of 1933, as amended.
The Company intends to carry on the business of Mitovie, as its primary line of business. The Company has relocated its principal executive offices to BioCity Scotland, Newhouse, Lanarkshire ML1 5UH, UK and its telephone number is +44 1698 53 9797.
After the Exchange, the Company intends to change its name to Altovida Pharma, Inc . Unless the context otherwise requires, hereafter in this Current Report the terms “Mitovie,” “the Company,” “we”, “us” or “our” refer to Remmington Enterprises, Inc. (to be named Altovida Pharma, Inc
.), after giving effect to the Exchange.
DESCRIPTION OF BUSINESS
Forward Looking Statements
Some of the statements contained in this Form 8-K that are not historical facts are “forward-looking statements” which can be identified by the use of terminology such as “estimates,” “projects,” “plans,” “believes,” “expects,” “anticipates,” “intends,” or the negative or other variations, or by discussions of strategy that involve risks and uncertainties. We urge you to be cautious of the forward-looking statements, that such statements, which are contained in this Form 8-K, reflect our current beliefs with respect to future events and involve known and unknown risks, uncertainties and other factors affecting operations, successful capital raises, market growth, services, and products. No assurances can be given regarding the achievement of future results, as actual results may differ materially as a result of the risks we face, and actual events may differ from the assumptions underlying the statements that have been made regarding anticipated events. Factors that may cause actual results, performance or achievements, or industry results, to differ materially from those contemplated by such forward-looking statements include without limitation:
• Our ability to attract and retain management and field personnel with experience in our industry;
• Our ability to raise capital when needed and on acceptable terms and conditions;
• The intensity of competition; and
• General economic conditions.
All written and oral forward-looking statements made in connection with this Form 8-K that are attributable to us or persons acting on our behalf are expressly qualified in their entirety by these cautionary statements. Given the uncertainties that surround such statements, you are cautioned not to place undue reliance on such forward-looking statements.
Information regarding market and industry statistics contained in this report is included based on information available to us that we believe is accurate. It is generally based on academic and other publications that are not produced for purposes of securities offerings or economic analysis. We have not reviewed or included data from all sources, and we cannot assure you of the accuracy or completeness of the data included in this report. Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and the additional uncertainties accompanying any estimates of future market size, revenue. We have no obligation to update forward-looking information to reflect actual results or changes in assumptions or other factors that could affect those statements. See “Risk Factors” for a more detailed discussion of uncertainties and risks that may have an impact on future results.
Overview Mitovie is a specialty pharmaceutical company focused on the development and commercialisation of medicines in areas of real clinical need.
The company adopts a unique approach to management of the risks associated with drug development. Mitovie incorporates soon to market drug development projects and a portfolio of commercial drugs which it markets predominantly in its home market of UK/EU. Whilst these commercial products offer the opportunity for revenue growth, the main thrust of the business is to complete the development of its high-value projects and commercialise them in the main global markets (initially through partners), with a priority focus on the USA and EU.
The development portfolio includes 5 high-value, relatively low-risk and soon to market medicines, of which 2 are lead - MVP022 & MVP025. These medicines are an autoinjector versions of naloxone (for the treatment of opioid overdose) and midazolam (for sedation in aggressive patients and treatment of acute seizures), respectively. Cost from initiation to registration is very low by regular pharma terms. Time to market for each of the lead projects is 2.5 years. During that time, the company plans to engage in development activities, compile regulatory dossiers and submit for approval to the regulatory authorities (e.g., the FDA). The founders have so far invested $3.4 million in the company’s pipeline. The company will need to raise capital to bring its development product portfolio to market. The company raised roughly $850,000 to commence its first project, MVP022, but will need more like $10 million in order to commence work on all projects in the pipeline. If the company is unable to raise more money, it will have to resort to finishing its first project and then commencing subsequent projects with revenues generated from MVP022.
The commercial product portfolio includes proprietary medicines and recently in-licensed therapies. This is supported by small scale, inexpensive in-house manufacturing which ensures continuity of supply of these critical medicines and favourable product margins.
The company was established to provide a solid commercial base in support of the progression of its high-value drug candidates. Our goal is to involve very low staff numbers relative to typical specialty pharma. We believe the existence of a sound commercial platform, along with low and tightly-maintained overheads, ensures that invested funds are focussed on expediting the approval of the high-value development drugs. It also allows the company headroom in the event of unforeseen issues in the development pathway.
The company has a steady flow of product opportunities, both commercial and development since all of its concepts originate in the clinic. It is through years of close contact with clinicians, patients and advocacy groups that Mitovie has built up a portfolio of genuinely needed products. In short, it listened to the market. As such the company is able to live true to its motto ‘ Seek the answer.’ It starts with a clinical problem identified by the medical community and explores every avenue to solve the problem pharmacologically. If the resultant medicine has the potential to garner defensible IP, it is selected for full development; if not it becomes a commercial product. By adopting this approach, we believe Mitovie is already seen as a true partner by the medical community it serves.
Mitovie adopts a unique approach to managing the risks associated with drug development. Big Pharma has traditionally been supported by the investment of billons in drug discovery where very few molecules from the millions screened make it through to become, often blockbuster, medicines. Specialty Pharma adopted an approach that removed the need for discovery by utilising existing known, off-patent, molecules in different ways or for different therapeutic indications. This means that these companies are not required to carry out expensive pre-clinical safety studies as the safety profile of the molecule has often been established for many years. These medicines, whilst they do not commonly achieve blockbuster status, regularly go on to sell profitably having utilised a fraction of the R&D budget attributable to their Big Pharma cousins. More often than not, these companies identify themselves by a therapeutic niche (e.g. ‘the neurology company’) or by some proprietary IP by way of formulation technology or a device, for example.
Mitovie’s approach is different in that it begins with the medical challenge, not the IP/molecule and is never restricted by therapy area or delivery method. In doing so, the company mitigates the risk of changes in clinical practice within a single therapy area and opens itself up to a wider IP portfolio, whilst a commercial need is ensured. Essentially the company takes the medical challenge, ascertains which existing molecule should be effective once in the body, then works out the best method of administration. This sounds simplistic however so many other considerations get in the way of this being the standard methodology in drug development.
For Mitovie, there must be enough evidence reported in the literature (usually lead by interested clinicians) to support the use of the molecule in the proposed indication. This gives the company confidence that any clinical trial will be successful prior to investing in it. It also helps provide bibliographic support for the company’s applications to the authorities. For Mitovie’s lead candidates, the molecules are already licensed in the key territories, for the intended indications; Mitovie proposes to provide them in fit-for-purpose presentations for the first time. This minimises the regulatory burden of proof. Furthermore, the therapeutic indication for these first two candidates involves binary clinical outcomes; they either work or they don’t, there is no sliding scale.
Responding to the rapidly increasing levels of prescription opioid use in Western countries, Mitovie is developing an easy to use, naloxone auto-injector. Naloxone is an opioid receptor antagonist that can rapidly reverse the overdose of either prescription (e.g. OxyContin) or illicit (e.g. heroin) opioids.
Prescription opioid use is becoming more prevalent globally, particualry in the USA. Nearly 257 million prescriptions for opioids were written in the USA in 2009 alone. While prescription opioids such as OxyContin and Vicodin are needed to treat chronic pain, abuse rates have also risen and overdose mortality rates closely correlate with opioid sales. In 2008, approximately 36,450 people died from drug overdose in the USA. At least 14,800 of these deaths involved prescription opioids (FDA, 2012). Moreover, according to the Substance Abuse and Mental Health Services Administration, the number of Americans in 2009 aged 12 and older currently abusing pain relievers has increased by 20% since 2002.
Mitovie plans to acquire the global rights for a suitable device in 2014. Revenue from the project will be realised from the point of out-license, by way of a signing-on fee, predicted by Q4 2015 or a little later.
This product is an intramuscular auto-injector of midazolam, initially for sedation with the main life-cycle extension coming from an epilepsy indication.
Health services often manage agitated or violent people and such behaviour is particularly prevalent in emergency psychiatric services and general emergency departments. In the UK alone, the National Health Service (NHS) deals with more than 150 aggressive/violent patients every day at a cost of $170 million per annum. Guidelines recommend that these patients should be calmed by the use of words and reassurance, however the acute danger of the situation (to staff, the patient and others) often makes this impossible. To ensure the safety of everyone involved, rapid tranquilisation of aggressive or violent patients is often unavoidable. Drugs used in the setting include the benzodiazepine midazolam.
Mitovie is developing a single use auto-injector presentation of midazolam for use in this setting. The main advantage of the auto-injector in this setting is speed and ease of use versus drawing up and managing an injection via syringe, particularly if the patient is being restrained but unlikely to be still. Of equal import however is the reduced risk of needle stick injury. This is a phenomenon where the person administering the injection accidentally then stabs the needle into themselves or a colleague, placing each at risk of infection/cross-contamination. This is particularly an issue with a moving patient. The needle of the auto-injector retracts immediately when the device has finished delivering the dose of drug and cannot then physically be removed.
It is proposed that an epilepsy indication is sought for MVP025 following its approval for sedation. This will extend the regulatory life of the product and realise significant additional annual sales.
Mitovie has a pipeline of projects with similar development strategies to its lead projects. Development of these may start as soon as cash-flow allows, however they are planned to commence after the initial return of revenue from MVP022 or if the company is successful in raising additional funds through outside investments.
A product aimed at non-USA markets for the treatment of constipation.
Aimed at all global markets, this is a product used in the treatment of Motor Neuron Disease.
Another global product, this is a treatment for Parkinson’s Disease.
Mitovie currently sells a range of proprietary medicines, predominantly in the UK/EU. Sales of these products are predicted to grow slightly in the planning period.
To ensure growth and to drive profitability, Mitovie has new proprietary products to bring through and will in-license key medicines from third parties.
Mitovie has built a small manufacturing facility and laboratory at its BioCity Scotland site. Mitovie is currently finalizing a small scale manufacturing capability in the UK to both develop and manufacture its current range of proprietary medicines. In due course this will expand to both develop and produce higher batches of its most common lines as well as initiating newer high barrier to entry brand lines to broaden its range and improve its margins. These include a wide range of sterile pharmaceutical preparations identified as high need medicines in key territories such as Europe.
The competitive landscape primarily involves the company’s portfolio of development drugs, since the current commercial products have unique positions in their markets such that there are no true competitive medicines at this time. New competition for the development projects include potential intranasal preparations of naloxone (for example developed by AntiOp Inc) and intramuscular injection versions (for example developed by Kaleo Inc). Furthermore, an intranasal preparation of midazolam is in development (Upsher Smith Inc) which could compete with MVP025. Current competition to these projects is in the form of generic ampoules/vials of these medicines which whilst inexpensive, are not suited to SOS situations in the community. http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=10038701