Verseon (VSN.L) Final Results And Good Progress On New Family Of Anti-Coagulants
3/9/2016 10:02:52 AM
Verseon (AIM:VSN), a technology-based pharmaceutical company, today announces its Final Results for the year ended 31 December 2015.
• Verseon’s new class of oral direct thrombin inhibitors show excellent results in preclinical efficacy studies while demonstrating reduced risk of bleeding relative to current novel oral anticoagulants (NOACs). The anticoagulation program is making steady progress toward investigational new drug (IND) filings.
• Progress on the DME program has led to the design of many promising novel, selective candidates representing multiple chemotypes.
• Our angiogenesis inhibitors, characterized by a novel mechanism of action and low cytotoxicity, continue to show excellent activity in key functional assays.
• Expanded the research team with numerous scientists with strong professional backgrounds and excellent academic credentials.
• Purchased and began the renovation and development of an 85,000 square foot facility that is integral to the Company’s growth plans. It will contain advanced research laboratories and consolidate the Company’s departments into one location increasing operational efficiency. It will support the acceleration of existing drug development programs and enable the launch of additional programs in the near future.
• Net loss was $7.7 million or $0.06 per basic share, compared to a net loss for 2014 of $8.1 million or $0.26 per basic share.
• Research and development expenses were $4.5 million, compared to $3.5 million in 2014.
• Costs include a stock based compensation expense of $1.4 million compared to $4.3 million in 2014 and currency exchange gains of $1.9 million, compared to $nil in 2014.
• Total assets on the balance sheet stood at $85.7 million compared to $0.1 million at the end of 2014.
• Cash, cash equivalents and short term investments stood at $74.7 million, compared to $17 thousand at the end of 2014.
• Property and equipment along with long term investments totaled $10.8 million, compared to $82 thousand at the end of 2014.
• In August 2015, the Company purchased a property through its wholly owned subsidiary, VRH1 LLC, for $8.7 million.
• In May 2015, the Company raised £65.8 million ($100 million), before expenses, by issuing 32,569,047 shares of common stock in the Company (“Common Stock”) at a price of 202p each in an initial public offering (IPO) on the Alternative Investment Market of the London Stock Exchange (“AIM”).
Adityo Prakash, CEO of Verseon Corporation, commented: “We are pleased to report significant progress with the expansion of Verseon's operations this year. All our drug discovery programs continue to advance, and we look forward to the IND for our anticoagulant program. During our build-out we have succeeded in maintaining a low cost base, with net loss per share lower than expected. We would like to thank the members of the Board, our employees and our shareholders for their ongoing and continued support. We are confident that together we are building a solid foundation for success."
Highlights from annual report
Our most advanced drug program has produced multiple novel anticoagulant candidates for the treatment of cardiovascular disorders such as stroke prevention for non-valvular atrial fibrillation patients, venous thromboembolism, and acute coronary syndrome. Using our drug discovery platform we have generated a portfolio of anticoagulant candidates across different novel chemotypes, representing novel chemical matter. These candidates have demonstrated comparable preclinical efficacy to existing anticoagulants but with substantially lower bleeding liability. Furthermore, our candidates have pharmacokinetics profiles with half-lives, exposure, and bioavailability suitable for oral dosing.
Our anticoagulant candidates are potent and selective direct thrombin inhibitors (DTIs) that bind to thrombin through a unique mechanism of action via reversible, covalent inhibition. This mechanism is responsible for the novel pharmacology of our DTIs and distinguishes them from existing novel oral anticoagulants (NOACs). In particular, our anticoagulant candidates demonstrate significantly reduced bleeding in preclinical studies without sacrificing efficacy while maintaining rapid onset of action. As such, our DTIs represent a novel class of anticoagulants with the potential to significantly impact the standard of care of many important cardiovascular indications.
We have demonstrated strong efficacy in three different established preclinical models providing compelling evidence for the therapeutic potential of our anticoagulant candidates for cardiovascular conditions.
One such preclinical efficacy model is the iron chloride induced arterial thrombosis model. The results from the induced arterial thrombosis model show comparable efficacy to existing anticoagulants.
Another preclinical model to assess efficacy is the widely accepted and sophisticated arteriovenous shunt (AVS) model. Again our DTIs demonstrated comparable efficacy to dabigatran with thrombus sizes substantially lower than no treatment. Moreover, further testing shows a good concentration-dependent response for our anticoagulant candidates. These preclinical AVS results conclusively demonstrate the effectiveness of our DTIs as potential treatments for arterial-related thrombosis such as those encountered in stroke prevention in non-valvular atrial fibrillation and in acute coronary syndrome.
The current anticoagulant global market is over $12.5 billion and is expected to grow to over $18.5 billion by 2018. Until recent years, the only treatment options were warfarin (Coumadin) and heparins. The latter is administered by infusion and is expensive to source or manufacture. Warfarin, while available as an oral generic medication, is plagued by a slow onset of action, a multitude of drug-drug and drug-food interactions, and significant bleeding risks.
Several novel oral anticoagulants have been developed in recent years with the goal of replacing warfarin and heparins. The NOACs include dabigatran (PradaxaTM), rivaroxaban (XareltoTM), apixaban (EliquisTM), and edoxaban (SavaysaTM). Whilst these NOACs offer several benefits over warfarin and heparins, their adoption has been negatively impacted by the risk of major bleeding associated with such therapies. This includes high frequency of gastric bleeding forcing termination of use and heightened risk of intracranial bleeding, as well as other side effects.
Our current focus in the anticoagulant program is the nomination of development candidates for completion of IND-enabling studies and subsequent IND filings. These development candidates will be nominated based on their potency, selectivity, efficacy, safety, and oral pharmacokinetic and other biochemical properties. As part of this process we are developing a package of preclinical efficacy and safety models to best position our anticoagulant program for IND filing.
The Verseon discovery platform
Our proprietary, computational drug discovery platform can consistently design novel drugs that are unlikely to be found using conventional methods by exploring a vast chemical space of novel, drug-like synthesizable compounds for each program. It consists of a molecule creation engine that can generate a practically unlimited supply of novel compound designs, a molecule modeling engine that can accurately test those designs against a target protein, and integration with optimized laboratory processes.
Conventional computational efforts have been hampered for years, in large part due to their reliance on heuristics, training sets, and empirical models. Such approximations are typically made in order to reduce the complexity of the problem, but at the cost of sacrificing accuracy by over-simplifying the underlying physics involved.
Our approach is different. We rely on proprietary breakthroughs in molecular modeling, sophisticated optimization algorithms, and the efficient representation of synthetic and medicinal chemistry knowledge in the computer. We are committed to preserving our strategic advantage by continuing to improve our technology through continuing research.
Traditional techniques for finding drug candidates are based on trial and error and are prone to failure. We overcome this bottleneck by using our platform to design multiple, novel drug candidates for each of our drug programs. Having multiple candidates provides us with more options, resulting in more effective lead optimization, and providing more choices at each stage of the development process.
We believe that the success of our drug programs relies not only on the power of our drug discovery platform, but also on a commitment to the quality and integrity of our laboratory processes. This is the reason we have established our own biochemical laboratory staffed with highly-qualified scientists and equipped with advanced instruments. This is also the reason why we develop, as needed, advanced laboratory methods that include customized assays and preclinical models. Our current drug programs have benefited from these efforts.
Notes to editors:
Verseon is a pharmaceutical company that employs its proprietary, computational drug discovery platform to develop novel therapeutics for today’s challenging diseases. The Company is applying its platform to a growing drug pipeline and has three active drug programs in the areas of anticoagulation, diabetic macular edema, and solid tumor cancers.
For more information, please visit: www.verseon.com
The Company also announces the publication of its Annual Report and Accounts
The report and accounts for the twelve months ended 31 December 2015 are available on the Company’s website: (https://www.verseon.com/files/reports/verseon_ar_2015.pdf).
For more information
Simon Vane Percy Simon@vanepercy.com
Tel: +44 (0) 1737 821 890
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