Aspire Pharma Ltd.

Aldeyra Therapeutics has a date at the FDA, specifically Nov. 23 for its dry eye disease drug. After boldly claiming “ approvability has been put to bed ” last summer with a crossover study win, Aldeyra said Tuesday morning the US agency accepted its drug, reproxalap , for review. Reproxalap failed a Phase III trial in late-2021, but the drug’s maker followed up with another late-stage study testing a new primary endpoint and succeeded last June. A month later, the drug cleared a crossover study, in which it met the primary endpoints tested in both of the previous Phase III trials. FDA’s outside expert panel will not convene to discuss the drug, as of current plans, Aldeyra said. CEO and president Todd Brady said an approval could mean a “rapid and durable” new treatment option for patients “dissatisfied with currently available therapies.” The small biotech is going up against Novartis’ Xiidra and AbbVie/Allergan’s Restasis. A Phase III is also testing the drug in allergic conjunctivitis , with two late-stage win s already under Aldeyra’s belt in that indication. The company submitted the NDA last November, and Aldeyra submitted the approval request paperwork for another drug, ADX-2191 , for primary vitreoretinal lymphoma a month later. Cambridge, England, company Evonetix reeled in another $24 million for its Series B , bringing the round to more than $54 million. The proceeds will help Evonetix build out its semiconductor chips and its technology for gene-length DNA for research across a variety of fields: biopharma, food, agriculture and data storage. “Evonetix is in a very exciting phase, having recently opened our early access program. This investment will support us as we execute on our commercial strategy to put benchtop gene synthesis in the hands of users,” CEO Colin McCracken said in a statement. Financial backers include Foresite Capital, Molten Ventures, Morningside, DCVC, Cambridge Consultants, Civilization Ventures and Providence.

Oversubscribed round led by Foresite Capital Funding will enable development of DNA synthesis chip technology to commercial scale CAMBRIDGE, England--(BUSINESS WIRE)-- EVONETIX LTD (‘Evonetix’), the synthetic biology company bringing semiconductor technology to DNA synthesis, today announced it has completed a USD $24 million financing round, extending its total series B funding to over USD $54 million (circa GB £44 million). This fundraise was led by existing investor Foresite Capital, with Molten Ventures, Morningside, DCVC, Cambridge Consultants, Civilization Ventures and Providence also participating in the round. The investment will enable the continued development of Evonetix’s semiconductor chips to commercial scale, and the extension of gene assembly capabilities for its unique binary assembly technology to deliver accurate, gene-length DNA in a benchtop instrument. The platform has the potential to revolutionise the way this DNA is prepared and delivered to users in the rapidly growing field of synthetic biology, accelerating research in applications across pharma, biotech, food, agriculture, and data storage. Colin McCracken, Chief Executive Officer at Evonetix, commented: “This substantial investment round demonstrates continued confidence in the progress of our technical development and its potential to revolutionise the accessibility of gene synthesis. Evonetix is in a very exciting phase, having recently opened our early access program. This investment will support us as we execute on our commercial strategy to put benchtop gene synthesis in the hands of users.” Paul Beastall, Chair of the Board of Directors at Evonetix, said: “We’re delighted to have secured additional funding from our existing investors in this oversubscribed round, testament not only to the promise of our novel approach to gene synthesis, but also the unrivalled expertise of our interdisciplinary team.” Jim Tananbaum Founder and Chief Executive Officer at Foresite Capital, commented: “We continue to be impressed by the Evonetix team and technology, and are excited to lead this round to accelerate their commercial strategy and make gene synthesis more accessible." Nelly Markova, Principal, Molten Ventures said: “Molten has been a big supporter of Evonetix from the early days. We are delighted with the huge progress the company has made towards revolutionising the gene synthesis process and look forward to continuing our partnership.” Evonetix’s proprietary synthesis process utilises a novel silicon chip, to control the synthesis of DNA at many thousands of independent thermally controlled reaction sites, or ‘pixels’, and their assembly into highly accurate long DNA on the chip surface through the company’s patented Binary Assembly process. This approach enables the accurate synthesis of thousands of sequences on a single chip to meet the demand for complex libraries and assembly of long DNA in days rather than weeks, accelerating research across the exciting field of synthetic biology. For more information about Evonetix, please visit: ENDS View source version on businesswire.com: Contacts Lorna Cuddon Zyme Communications Tel: +44(0)7811996942 Email: lorna.cuddon@zymecommunications.com Source: Evonetix View this news release online at:

PharmaTimes presents Alantra’s annual ranking of the fastest growing private pharma companies in the UK In 2020 the world turned upside-down and the pharma sector was no exception. As COVID-19 spread globally and lockdowns took effect, the industry responded with a surge of adaptability, resilience and innovation. This response is borne from the key trait we see every year in the constituents of the Alantra Pharma Fast 50, our annual ranking of the 50 fastest-growing privately owned pharmaceutical businesses in the UK. The common theme among these businesses is a relentless focus on innovation. There has never been more public attention on what it takes to deliver an effective drug to patients than over the last 12 months. The businesses in the Pharma Fast 50 touch on every element of that – from early stage research right through to ensuring vital medicines continue to flow across borders. Some are using artificial intelligence (AI) to identify and design the most promising drug candidates at a faster rate than ever before, others are providing deep development and clinical experience to progress these with the lowest rate of attrition possible. Elsewhere businesses are using digital to replace face to face communications. Others still are ensuring pharma can access patients to understand the true nature of living with a condition or enabling distribution to ensure life-changing treatments are widely available. Each of the businesses in this year’s Pharma Fast 50 is determinedly focused on solving the problems getting in the way of better outcomes for patients. This relentless advance is driving performance ever higher. This year’s 33% average growth compares to 27% in last year’s report. And at the top of the ranking, this year’s fastest-growing company, Exscientia, has almost quadrupled its revenue in the last two years. These businesses deserve their success. The way in which the pharmaceutical industry has confronted the difficulties of the past 12 months has been inspiring, and it is not only big pharma and biotech that has risen to the challenge. The Alantra Pharma Fast 50 shines a light on the incredible work of many of the industry’s most innovative growing businesses. Technology: AI drives progress “Architects don’t work by constructing 15 buildings to see which one is the safest and most effective use of space; they run models to test potential designs,” says Aaron Morris, founder of the machine learning specialist PostEra. “But drug discovery still relies on trial and error, with chemists going through as many as 5,000 compounds that have to be made and tested in a lab.” Clearly, this approach is expensive and time-consuming – a major challenge for the small biotechs which make up an ever-increasing proportion of the drug pipeline and an inefficient approach for big pharma – but Morris believes technology provides the solution. PostEra’s algorithms not only help biotechs identify which compounds are most likely to deliver the desired results in treatment, but importantly, also pinpoint which ones are practical to make and the most efficient route to doing so. That should enable early-stage development work to move forward much more quickly. PostEra is just one example of a growing number of businesses bringing cutting-edge AI technologies to the pharma sector. There has been hype about the potential for such tools for some years, but that is now being realised. The fastest growing business in this year’s Alantra Pharma Fast 50 also operates across the space; Exscientia is proving that its innovative use of AI and data science can revolutionise discovery (see profile opposite). “We now have the proof points showing the AI definitively works in drug design,” says chief executive (CEO) Andrew Hopkins. More broadly, the pharma sector is at last beginning to recognise the transformative potential of technology, argues Andy Black, Professor of Practice at King’s College London, who also chairs pharma businesses including Sygnature Discovery and Synetic Life Sciences. “Technology is now pervasive,” says Black. “Tech-enabled businesses employing tools such as automation, data analytics and other digital technologies are operating at a new level.” He points to examples ranging from advances in high throughput screening to the use of wearables in gathering data to support mental health patients. Perspectum, the third-placed business in this year’s ranking, offers another example of a business doing remarkable things with advanced technology, in its case fundamentally improving patient outcomes and experience. It uses data from MRI scans to build remarkably detailed maps of organs such as the kidney and the liver, in order to help physicians make accurate diagnoses without invasive procedures such as biopsies. The technology lends itself to much better long-term management of conditions and has a huge potential market. “These digital diagnoses are so exciting,” says Dr Rajarshi Banerjee, founder and CEO of Perspectum. “We’re asking a patient to attend an outpatient appointment for an MRI rather than putting them through a painful biopsy, and we’re getting better-quality diagnoses that cost much less.” Like many technology businesses operating in the sector, Perspectum operates with a software-as-a-service (SaaS) model, that provides practitioners with an affordable entry point to its technology. That has worked well for Perspectum, which has grown rapidly since its launch in Oxford in 2012, but Dr Banerjee cautions that working out what is a commercially viable business model remains a key challenge for scientists – particularly those whose enterprises have spun out of academic communities. “Just in our time, we’ve seen more spin-outs in Oxford than ever before, but the leadership of these newly formed companies often need help understanding what makes great science a great business,” he says. Still, the future looks bright for technology businesses with a pharma focus, particularly given the talent coming through. PostEra’s Aaron Morris says such firms are now attracting the brightest graduates from leading universities, while Andy Black points out that the UK now has an opportunity, post-Brexit, to take a lead on digital regulation. “The UK can genuinely build one of the world’s most attractive digital pharma ecosystems,” he suggests. Outsourcing – two heads are better than one Big pharma’s drive for efficiency, and the ever-growing contribution to drug development from biotech – including the growing number of entirely virtual firms – shows no signs of slowing. This continues to underpin a drive towards outsourcing of research and development. Lean and efficient biotechs, focused on their core competencies, require external support and expertise, giving rise to an increasingly sophisticated development chain delivered by outsourcers, each with their own domain expertise. The best of these operate not as simple outsourced providers, but as genuine partners to their clients. This is driving growth for companies such as BioAscent, the fastest-growing pharma outsourcing business in the Alantra Pharma Fast 50 for the second year in succession. This is a global phenomenon, says Paul Smith, BioAscent’s CEO, “We are seeing a growing portion of our new work coming from the US, we see this becoming a dominant market for us”. The key to winning – and retaining – business in this market is quality of service and outstanding science, Smith argues. BioAscent has steadily expanded its range of services, from biology, chemistry and compound management into new areas such as computational chemistry, “allowing us to provide a more full and efficient service to our clients.” But ultimately it is the firm’s individual scientists who drive its success. “We are trying to deliver a seamless set of services provided by absolutely the best people,” Smith says. In an industry where competition for talent is fierce, recruitment and retention have to be a key focus. BioAscent, like many others, has worked hard to support and reward its staff over the past 12 months during the difficulties of the COVID crisis. Smith wants to help staff build careers with the business – the typical employee has 15 years of industry experience and the firm has a sharp focus on sustaining a team of that experience and quality as it scales. Meanwhile, other parts of the outsourcing sector build on the work done at an early stage by the likes of BioAscent. Here, the challenge is to ensure drugs make it through the development stage to commercial success, or at least that those with limited chances of success are weeded out at the earliest possible point. That requires development partners with an understanding upfront of which drugs are likely to survive the whole development pathway, and where the greatest risks of failure lie. At Seda Pharmaceutical Development Services, for example, CEO Paul Stott points to the challenges of drug delivery, both in the emerging modalities and in complex small molecule development, where issues such as poor solubility are increasingly common. “The challenge with more complex molecules is so often the delivery,” Stott says. “We have the technical expertise and experience in drug delivery to take the uncertainties out of the decision-making process. Through design and laboratory testing we ensure a drug product will have the desired performance in patients.” Seda provides an unusual, integrated mix of deep pharmaceutical development and clinical pharmacology knowledge – or helps with “product design to ensure product performance” as Stott describes it. He argues that such businesses, which are able to supply skill-sets often missing from other types of CRO, and provide a holistic view of the development pathway, will be increasingly crucial. At Global Perspectives, CEO Joe Waby also pinpoints the firm’s unique skills as a key differentiator. Global Perspectives helps clients access participants for studies to produce crucial real-world evidence, working with patients across multiple geographies and a range of diseases and conditions. “We provide every patient we recruit with a human point of contact at the company, who spends time with them talking about the study, ensuring they fit the criteria and are bought into the purpose of the trial,” Waby explains. “This can be extremely emotional for patients – often they are unaware of the studies we’ll be contacting them about, and these have the potential to make a very meaningful improvement to their quality of life”. That requires Global Perspectives’ staff to have a detailed understanding of what their clients need, and to build empathetic relationships with potential study participants. The market for these businesses continues to grow – across geography, therapeutic area and modality. And the rise of technology-enabled business models provides further impetus – BioAscent, for example, points to the growing number of AI-focused biotechs in its client base; such clients require rapid response to quickly translate modelled results into physical ones. For all these reasons, outsourcers now look set for further growth, with a broad variety of innovative UK businesses well-placed to benefit. The value of good communication While technologists and specialist outsourcers are accelerating the pace of drug development and reducing cost, any medicine closing in on approval has still received significant investment. The pressure to deliver commercial success therefore remains as high as ever – and driving that success is only getting harder. Accordingly, it is vital to articulate the benefits of new products – and their points of differentiation – in order to secure regulatory approval, buy-in from payers, and physicians’ support. This is why businesses offering analytics, insight and communication (AIC) services are performing so strongly. These firms’ deep understanding of clients’ key therapeutic areas is crucial to converting the work done by drug developers’ functional expertise into marketable assets. Businesses such as global healthcare communications and strategic consultancy agency Helios Medical Communications, the fastest growing business in the AIC category of this year’s Alantra Pharma Fast 50, are powering ahead. Such companies are most likely to succeed when they can offer clients deep-seated therapeutic area expertise as well as high-quality communications, says Andrew Minnock, managing director of Helios. “Therapeutic area and scientific expertise are key. We wouldn’t win new business or grow our existing accounts without this,” Minnock says. “Clients also need excellent service: demand in our space may outstrip supply, but customers will switch quickly if you’re not providing a top-level service. The answer is therefore to recruit the best people and to work hard on retaining them. At Helios, we have a strong focus on creating a positive working environment and providing significant personal development opportunities for our employees.” The segments of this market growing most quickly broadly reflect the trends in the wider market. There is increasing demand for agencies able to work in specialised therapeutic areas and rare diseases and clients are looking for partners to provide support developing their entire strategy for communicating the value of a drug, rather than just implementing an existing strategy on their behalf. Digital and personalised engagement channels play an increasing role. Indeed, digital tools can convey information in completely new ways, vastly improving the chosen audience’s understanding of key messages. The medical animation business Random42 is one good example, working with a broad range of clients to provide them with compelling materials – for both the medical profession and potential investors. “Our business is really benefiting from the increasing range of modalities in drug development,” says Random42’s CEO Ben Ramsbottom. “As products become more complex, animation can really help to tell their story.” The company’s growth has also been powered by the explosion of biotechs in areas such as Boston, North America, with each new venture needing a way to get its unique message across. That has prompted Random42 to invest in business development and back-end service capabilities over the past 12 months as it seeks to scale its growth even further. New technologies, such as augmented and virtual reality, provide further scope for development in the years ahead. DWS businesses complete the circle Businesses in the final category of the Alantra Pharma Fast 50 – developers, wholesalers and suppliers (DWS) – provide the final links in the industry’s value chain, from selecting the disease areas to target and treatments to develop, to managing the practical challenges of getting drugs into frontline delivery. WEP Clinical, the leading DWS business in this year’s ranking, is one fascinating example of the latter. It works to ensure patients can access life-saving drugs often not currently licensed in the country in which they reside – products still going through trials, for example, and treatments licensed in one country but not others. WEP started out with a focus on helping hospitals and physicians seeking treatments for their patients – often drugs of last resort or for rare diseases. Today, it works on a larger scale, helping biotech and pharma to ensure patients have access to drugs, often after trials finish but before full commercial launch – a period that could be agonisingly long for patients if they did not have access to those products. Joint managing director Jaswant Khera launched the business in 2008 with his brother Jaswinder. “We wanted to do something meaningful,” he says. “Very often we are supplying medicines to patients who would die without them, and we take that very seriously.” WEP has grown rapidly over the past few years, investing in business development and focusing on its market expansion work. Khera sees a growing opportunity to help pharma and biotech commercialise their products in markets they may not have the experience or resources to target for themselves, bringing clients’ products into markets where they might otherwise have never been approved. In the meantime, the company has been focused on dealing with the challenges of Brexit, with the UK and the European Union implementing their eleventh-hour trade deal on 1 January. “It has been a challenge, with delays and costs even though we were promised a tariff-free settlement,” he says. For others, there is a question as to whether Brexit represents opportunity. Graham Fraser-Pye, managing director of Aspire Pharma, another top-performing DWS business in the ranking, is focused on how the MHRA will deliver regulation in the UK. “They have shown what they are capable of with the expedited approval process for the COVID-19 vaccines,” says Fraser-Pye, echoing the hopes of the technology sector that the MHRA will be innovation friendly. “This is a positive opportunity for the British life sciences industry.” Aspire itself, which constantly develops new medicines across a range of therapeutic areas, continues to grow strongly. It currently has 40-50 products in its pipeline and has expanded in areas such as dermatology and ophthalmology over the past 12 months. “Our starting point for development has been identifying products to improve patient care in the UK,” says Fraser-Pye. “Then there is a growing opportunity to internationalise our innovations and IP.” It is yet another example of an innovative and entrepreneurial UK pharma business finding smart ways to create value. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Exscientia tops the ranking “I truly believe all drugs will be discovered using artificial intelligence by the end of this decade, such are the advantages,” predicts Andrew Hopkins, the CEO of Exscientia, the fastest-growing business in this year’s Alantra Pharma Fast 50 ranking. The business’ recent performance has been remarkable, with compound annualised growth of 98% over the past two years, but Hopkins believes this is just the beginning. “We were the first company founded to automate drug discovery with AI. When we launched this business, there was a great deal of scepticism that something as creative as drug design could be done using AI, but we now have the proof points that show it can work,” Hopkins says. Not least, the company already has six drugs going through the preclinical toxicology process, including one that has moved into clinical trials, with others on the verge. Exscientia thinks of itself as a technology company specialising in the field of pharma – or a pharmatech company, as opposed to a biotech. “We’re a technology business that develops drugs,” says Hopkins. “Drugs are precision engineered technologies, so we’re really a design company – it’s just that what we’re designing is at the molecular scale.” The company builds complex data sets from material such as academic papers, historical databases and public patent records, or works to build new data sets in areas where such information is in short supply using techniques called active learning. It then uses a range of machine learning and artificial intelligence tools to automate the process of drug design, generating and sorting through billions of potential compounds to identify the best-looking candidates. “The problem facing the industry is that drugs take too long and cost too much to develop,” Hopkins explains. “We’re using technology to confront that challenge.” The six compounds it has moved to the preclinical stage so far got there in around a fifth of the time that conventional drug discovery would take, he says. Exscientia works with both big pharma and smaller biotechs as well as developing its own pipeline. Exscientia usually works in partnerships, running discovery operations, co-developing product and taking on a significant portion of the risk and reward. Hopkins believes the future of the business lies in having a full stack platform across the preclinical phase of development, continuing to work with external parties while also progressing its own pipeline. As such, the company’s staff – which Hopkins expects to double to 200 this year – are roughly split equally between technology specialists and drug discoverers – biologists and chemists – with pharma expertise. The company also has 10,000 square feet of its own lab space. Hopkins adds: “Our goal is to accelerate the production of the investigational drugs, with all the data required around safety and efficacy, to get them into commercial development as quickly and as cost-effectively as is possible.” - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Leading the battle against COVID-19 The UK’s life sciences industry has a crucial role in helping the world to overcome the COVID-19 pandemic. The remarkable vaccine developed by the University of Oxford and AstraZeneca is well-known, but it is important that the huge contribution being made by the broader sector, including many of the entrepreneurial businesses in the Pharma Fast 50, is not overlooked. These firms also deserve huge credit. Take PostEra, the technology business that has brought the power of machine learning to medicinal chemistry. Its Moonshot project is a not-for-profit crowdsourcing initiative hoping to accelerate the development of antiviral treatments for COVID. Last summer, PostEra founder Aaron Morris invited scientists to submit potential drug designs, to which it would apply its machine learning tools in order to identify the most promising candidates for lab testing. “We hoped we’d get 50 to 100 ideas, but so far we’ve had 15,000,” Morris says. With the help of a global team of partners, some 1,500 of those ideas have been physically made and tested with several of these drug candidates now in the later stages of development. “By March, our aim is to nominate a clinical drug candidate and begin securing regulatory approvals for human trials – it’s been a mind-blowing effort that has become the world’s largest open source drug discovery effort,” Morris adds. The leading outsourcer BioAscent, meanwhile, has made a crucial contribution to building the UK’s COVID-19 testing infrastructure. “We’re very proud that two of our team were approached by the Scottish government to set up the Lighthouse Lab in Glasgow,” says CEO Paul Smith. “They spent two months setting the lab up and getting it running. We wanted to play our part in the community response.” Perspectum, the leading Technology business in the ranking, has secured MHRA approval in the UK and is working with regulators to secure an emergency authorisation in the US for COVERSCAN MD, a new non-invasive, diagnostic tool for assessing long-COVID. Random42, the groundbreaking medical animation business, has helped vaccine developers to illustrate their work. And WEP Clinical’s logistical expertise has kept medicines moving across borders despite the near closure of transport networks worldwide. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Five years of the Alantra Pharma Fast 50 The 2021 Alantra Pharma Fast 50 ranking is the fifth edition of this unique analysis of the UK’s fastest-growing privately-owned pharmaceutical businesses. Collectively, these rankings provide a fascinating snapshot of the rapid progress that the sector and its individual businesses have made. In total, some 135 companies have appeared in the rankings over the past five years. That includes just four businesses that have been included in each and every year – Sygnature Discovery, Qualasept Holdings, Nova Laboratories and Evaluate Group. Of course, not every business in previous iterations of the Alantra Pharma Fast 50 has remained privately owned; ten of the 135 constituents have been acquired after appearing in the ranking. An appearance in the Alantra Pharma Fast 50 has also been a good indication of broader investment interest: some 13 companies have subsequently taken on private equity funding, either for the first time or in addition to previous transactions. The ranking itself has changed too. Categories have evolved to reflect the changing shape of the industry – a good example being the launch of our technology category this year. Last year we launched the ‘Ones to watch’ category to identify businesses that do not yet meet all the criteria to make the main listing but which are too exciting to omit. The first two businesses in this category were XenoGesis and Accession, Sygnature’s acquisition of XenoGesis since then is a strong accolade that they were a good pick. We’re excited to highlight the great work being done by this year’s Ones to watch: PostEra and Seda Pharmaceutical Development Services (see main copy for more). The industry’s growth is clear to see. In the first Alantra Pharma Fast 50, the constituent companies’ combined revenues totalled £2.3 billion; in 2021, this figure has risen to £3.1 billion – a near 35% jump. That reflects the growing challenge of making it into the listing. Back in 2017, the 50th ranked business had delivered compound annualised growth of 3% over the previous two years, while the number one firm posted 75%. By contrast, in this year’s ranking, no business with two-year average growth of less than 12% made the grade – and in top place, Exscientia delivered a stunning 98%. Average growth back in 2017 was 14% against this year’s figure of 33%. The UK’s privately owned pharmaceutical companies are, in other words, in rude health, combining scientific and commercial success to achieve lasting positive societal change. Long may it continue. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Tom Co a director at Alantra, the global investment bank, and is a specialist in the pharmaceutical sector