SOFINNOVA PARTNERS RAISES €333 MILLION CAPITAL IX EARLY-STAGE HEALTHCARE FUND
The firm manages €2B across its life sciences platform, €1B of which has been raised in the last 4 years
Paris, France – October 17th, 2019 — Sofinnova Partners, a leading European venture capital firm based in Paris, London and Milan and specialized in Life Sciences, announced today the close of its latest early-stage healthcare venture capital fund Sofinnova Capital IX, oversubscribed at €333 million. The firm now has more than €2B under management with more than €1B raised in the last four years across its platform of life sciences funds.
Pursuing the strategy it has consistently applied over the years for its flagship early-stage Capital funds, Sofinnova Capital IX will invest in the healthcare industry and more specifically in the biopharmaceutical and medical device sectors. Sofinnova Partners will seek to invest as a founding and lead investor in start-ups and corporate spin-offs, and focus on therapeutic, paradigm-shifting technologies and products alongside visionary entrepreneurs. Sofinnova Capital IX will invest about two thirds of its funds in European companies, and one third outside of Europe, primarily in North America.
The new fund has commitments from leading institutional investors, predominantly endowment funds, insurance companies, pension funds, sovereign funds, corporates and family offices, many of whom are continuing a long and successful relationship with the Sofinnova family of Funds. The majority of commitments came in from Europe, including France, Italy, Ireland, Denmark, Germany, Switzerland, the United Kingdom and Luxembourg, but also from leading North American investors in the U.S. and Canada, as well as major investors from Asia.
Antoine Papiernik, Managing Partner and Chairman of Sofinnova Partners, said, "Our experienced team, stable strategy and exit track record resonated well with investors, hence the success of our fundraising for this latest Capital fund. Over the last three years, we have completed nine remarkable exits in the portfolio for a total enterprise value of almost 4 billion euros."
The launch of Sofinnova Capital IX follows the formation, in just the last three years, of Sofinnova Crossover I, a fund investing in pre- and post-IPO companies; Sofinnova MD Start III, a medical device acceleration fund; Sofinnova Industrial Biotech I, a fund dedicated to industrial biotech; and Sofinnova Telethon Fund I, a fund dedicated to seed investments in gene and cell therapies based out of Milan, Italy. With these focused franchises managed by dedicated specialist teams, Sofinnova Partners has established a unique and comprehensive platform of investment vehicles across the life sciences investment value chain.
Triago acted as placement agent and Clifford Chance acted as legal counsel on Sofinnova Capital IX.
About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Headquartered in Paris, France, with offices in London and Milan, the firm brings together a team of 40 professionals from all over Europe, the U.S. and Asia. The firm focuses on paradigm-shifting technologies alongside visionary entrepreneurs. Sofinnova Partners invests across the Life Sciences value chain as a lead or cornerstone investor, from very early-stage opportunities to late-stage/public companies. It has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €2 billion under management.
For more information, please visit: www.sofinnovapartners.com
Kate Barrette
RooneyPartners LLC
kbarrette@rooneyco.com
Anne Rein
S&I
anne.rein@strategiesimage.com
Inotrem announces €39 Million Series B Financing to Develop First- In-Class Immunology Therapeutics
• Top-tier global life sciences investor Morningside Ventures led the financing round, joined by Invus and historic investors Andera Partners, Sofinnova Partners and BiomedInvest.
• Proceeds will be used to advance the Company's applications in a number of indications such as septic shock and chronic inflammatory diseases.
Paris, September 12th. 2019. Inotrem S.A., a biotechnology company specialized in the development of immunotherapies targeting the TREM-1 pathway with potential applications for acute and chronic inflammatory syndromes, announced today a €39 million Series B financing led by Morningside Ventures, joined by Invus with participation from existing investors Andera Partners, Sofinnova Partners and BiomedInvest.
The financing will support the clinical development of Inotrem's lead drug candidate, nangibotide (an anti-TREM-1 peptide) in a global multicentric Phase IIb trial in septic shock patients (ASTONISH trial) to deliver a meaningful proof of clinical efficacy, as well as its companion diagnostic tool using soluble TREM-1 as a mechanism-based biomarker to select patients that are more likely to respond favorably to treatment. This series B financing will also allow Inotrem to expand its TREM-1 franchise to address chronic inflammatory diseases.
"We are thrilled to have attracted world-class investors from the USA to advance what we believe is a new paradigm in immunotherapy" said Jean-Jacques Garaud, CEO of Inotrem,
"This financing validates the potential of our technology platform centered on the TREM-1 pathway and of our lead drug candidate for septic shock, nangibotide, which will be entering a large Phase IIb clinical trial later this year".
Based on a novel approach of immunomodulation which targets the TREM-1 pathway, Inotrem has developed a proprietary technology platform and leverages its extensive knowledge of the TREM-1 pathway biology to develop programs in several indications with inflammatory syndromes for which there is a major and today unsatisfied therapeutic need. Its lead compound, nangibotide, targets septic shock which is the ultimate complication of sepsis. The incidence of septic shock continuously raises and mortality remains elevated (35%) in developed countries. There is currently no specific mechanism-based therapy approved for this indication. Inotrem's solution has the potential to become the first mechanism-based treatment for septic shock.
"We have been strongly impressed by Inotrem's achievements until now and are convinced its approach of immunomodulation which targets the TREM-1 pathway could represent a step change in immunotherapy and bring solutions to patients that today lack effective therapies", indicated Jason Dinges of Morningside. In connection with the financing, Dr. Jason Dinges of Morningside will join the Inotrem's Board of Directors.
Bryan Garnier & Co, the European Growth Investment Bank, supported Inotrem with its fundraising.
About Inotrem
Inotrem S.A. is a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, LR12 (nangibotide), with potential applications in a number of therapeutic indications such as septic shock and myocardial infarction. In parallel, Inotrem has also launched another program to develop a new therapeutic modality targeting chronic inflammatory diseases. The company was founded in 2013 by Dr. Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr. Marc Derive. Inotrem is supported by leading European and North American investors. www.inotrem.com
About Nangibotide
Nangibotide is the formulation of the active ingredient LR12, which is a 12 amino-acid peptide prepared by chemical synthesis. LR12 is a specific TREM-1 inhibitor, acting as a decoy receptor and interfering in the binding of TREM- 1 and its ligand. In preclinical septic shock models, nangibotide was able to restore appropriate inflammatory response, vascular function, and improved animals' survival post septic shock. Nangibotide in septic shock has been granted the fast track status in September 2019 by the FDA.
ASTONISH Study
The Efficacy, Safety and Tolerability of nangibotide in Patients with Septic Shock (ASTONISH) phase IIb trial is a Randomized, Double-blind, Placebo Controlled Dose Selection Study that will be performed Europe and the US. Four hundred and fifty patients are planned to be included in this study in 48 clinical sites. The study will compare the effect of nangibotide at two different doses versus standard of care. The IND has been cleared by the FDA in August 2019.
Media contact for Inotrem
HotSpot Therapeutics Announces Acquisition of Macroceutics, Inc.
HotSpot to gain access to Macroceutics' custom DNA-encoded libraries comprising approximately one billion compounds with full screening and chemistry capabilities
Libraries to be integrated into HotSpot's SpotFinder™ platform which predicts, drugs and differentiates allosteric regulatory sites
BOSTON, Mass. (August 23, 2019)— HotSpot Therapeutics, Inc, a biotechnology company pioneering the discovery of nature's regulatory sites to advance allosteric drug discovery, today announced the acquisition of Macroceutics, Inc., a provider of DNA-encoded library (DEL) screening technologies. The outgrowth of a strategic collaboration, the acquisition will enhance HotSpot Therapeutics' SpotFinder™ platform, the first drug discovery platform to systematically predict, drug and differentiate unique regulatory hotspots on proteins. DEL is a next generation screening technique that enables millions of molecules to be rapidly synthesized and screened against a protein of interest.
"In working with the Macroceutics team, we were excited by their bespoke libraries and capabilities and the potential to marry the power of DNA-encoded library synthesis with specifically designed scaffolds to target regulatory hotspots," said Geraldine Harriman, PhD, Co-Founder and Chief Scientific Officer, HotSpot Therapeutics. "Using the rich structural information delivered by our platform, we have a roadmap for the design of customized chemical scaffolds. DEL technology allows us to translate these insights into millions of tailored scaffolds quickly, accelerating hit expansion and lead optimization efforts."
As part of the acquisition, HotSpot will be able to leverage approximately 1 billion custom drug-like molecules, the company's full suite of DNA-based chemistries, and a fully enabled screening platform. The Macroceutics team will join HotSpot Therapeutics, thereby establishing a new in-house DEL capability that will focus on custom library/methods development, screening of HotSpot pipeline and partnered targets and novel method development. Ken Carson, PhD, Founder and Chief Executive Officer of Macroceutics, Inc., will lead the DEL screening group as Executive Vice President, Chemical Sciences.
"It has been exciting to see how well tailored DEL design works in practice with HotSpot's platform technology. The success of our collaboration naturally led to a strategic relationship where we can fully integrate DEL into the SpotFinder™ platform," said Carson. "We are excited to be joining forces with the HotSpot team to develop new allosteric medicines."
Historically, it has been challenging to rationally develop small molecules against allosteric sites because allosteric pockets are difficult to distinguish from other protein sites. New chemistry and specialized assay techniques are often required to assess the binding and function of small molecules within allosteric pockets. Core to HotSpot Therapeutic's drug discovery strategy is a commitment to novel chemistry development that leverages the unique properties of regulatory hotspots to control protein function.
About HotSpot Therapeutics
HotSpot Therapeutics is targeting nature's regulatory mechanisms to create allosteric medicines that exhibit high precision and potency. The company leverages its proprietary SpotFinder™ technology, the first and only platform designed to identify "regulatory hotspots," a unique family of pockets that sit remote from the active site on a protein and are used by nature to control protein function. Using bespoke chemistry approaches, HotSpot is developing a pipeline of first-in-class small molecules for the treatment of serious autoimmune and metabolic diseases. The company has identified more than 100 regulatory hotspots across a range of proteins and pathways. HotSpot's lead compounds include the first and only allosteric inhibitors to target PKC-theta for autoimmune diseases, and S6 kinase, an immuno-metabolic enzyme involved in the regulation of hepatic insulin sensitivity and mitochondrial function – an important new target for NASH and metabolic diseases. To learn more, visit www.hotspotthera.com.
Lissette Steele
Verge Scientific Communications
lsteele@vergescientific.com
Learn more about HotSpot Therapeutics at: http://www.hotspotthera.com
AgroSavfe raises €35 million in Series C financing
AgroSavfe is a Belgium-based Company developing a new generation of safe and effective biocontrols
All existing, long-term investors participated in the capital round
Ackermans & van Haaren invested €10 million and joins the Board of the company
GHENT, Belgium, July 30, 2019 — AgroSavfe NV, a rapidly growing and transformative Crop and Food protection company developing a new generation of protein-based biocontrols to protect food from farm to fork, today announces the closing of a Series C financing round.
AgroSavfe, a spin-off from the VIB ('Vlaams Instituut voor Biotechnologie') founded in 2013, has developed a unique and versatile technology platform for the design and development of novel protein-based biocontrols providing safe, sustainable and efficient protection for seeds, crops and food. With more than 100 field trials since 2017, the Company's most advanced biofungicide has demonstrated strong performance, competitive with synthetic chemical solutions while offering absence of any residues. Agrosavfe's solutions benefit the environment while adding more value to the farmers' produce and meeting consumers' demand for healthier food. Beyond the field, AgroSavfe's product candidates also demonstrated strong impact on food protection and quality along the value chain, providing new solutions to reduce food loss.
The funds will be primarily used for the development, registration and commercial scale production of AgroSavfe's biofungicide and bioinsecticide products and to continue to strengthen the company's organization. The launch of its first biofungicide is scheduled for 2022 in the fruit and vegetables market in the US, immediately followed by a launch in Europe and other regions. In addition, the funds will support the accelerated development of the innovative pipeline with applications in critical food and crop pests and diseases.
Since its inception, AgroSavfe has been supported by strong local and international investors, including Gimv, Sofinnova Partners, PMV, Agri Investment Fund, K&E, Biovest, Madeli Participaties, VIB and Qbic. All existing investors participated in this €35M Series C financing round, joined by a new investor, Ackermans & van Haaren, a diversified long-term investment group, listed on Euronext Brussels, investing €10 million in this round.
Patrice Sellès, CEO of AgroSavfe commented: "AgroSavfe is rapidly growing as a competitive player in the biocontrol space for food protection based on our unique AGROBODY™ Foundry Platform and our ability to provide growers and food chain actors with innovative, safe and cost-effective solutions aligned with consumers' demand. Having such a diverse and strong team of investors joined by Ackermans & van Haaren is a fantastic asset for the long-term ambitions of our company".
Piet Bevernage, representing Ackermans & van Haaren, added: "We are very enthusiastic to be able to support the further growth and development of AgroSavfe. The company has a clear strategy, a unique technology platform, an excellent management team and experienced biotech investors. This combination will enable AgroSavfe to play an important role in the biological crop and food protection market and to provide a sustainable solution to major challenges of the agricultural sector, such as population growth, yield increase, food loss and the demand for safe and healthy food."
Lieven De Smedt, Chairman of the Board of Directors of AgroSavfe, concluded: "Having witnessed how Biotechnology added significant and unique value to the Life Sciences, Food and Chemicals markets over the last decades, we now see the same happening in the Agricultural sector, both in the US and in Europe. Long term success not only depends on robust technology and a strong business-minded management, it also requires long-term shareholders. AgroSavfe has a unique combination of all of the above, in particular with its syndicate of existing investors all fully endorsing the company in this round. We are very pleased to welcome Ackermans & van Haaren as a new shareholder in AgroSavfe, and especially Piet Bevernage as new Board member, adding diversity and significant expertise. We all look forward to continuing to build AgroSavfe as a leader in the emerging field of efficient and safe biocontrols for the Food and Agriculture industry."
About AgroSavfe
The growing demand for healthy, safe and sustainable food has increasingly imposed restrictions on agricultural practices. Therefore, improving production efficiency in a sustainable way, while safeguarding the environment and its natural resources, is essential.
AgroSavfe has the ambition to contribute to a sustainable production of safe and healthy food. The company focuses on the discovery, development and commercialization of effective and safe biocontrols to tackle plant pests and diseases using its ground-breaking, scalable, proprietary AGROBODY™ Foundry Platform.
AgroSavfe's products are a novel class of biocontrols based on AGROBODY™ bioactive proteins that effectively and selectively target pests' and pathogens' essential molecules. AGROBODY™ bioactives combine the high-performance characteristics of chemicals with the clean safety profile of biologicals, making them ideal crop protection agents for both pre- and post-harvest applications.
Based on its unique AGROBODY™ platform, AgroSavfe has built a versatile product pipeline against key pests and diseases, with the first product expected to enter the US market in 2022.
The company was founded in 2013 as a spin-off from the VIB (Flemish Institute for Biotechnology) and is based in the biotech cluster in Ghent, Belgium. More information can be found on www.agrosavfe.com.
For further information, please contact
Marieke Vermeersch, Corporate Communications & Investor Relations Consultant
E: marieke.vermeersch@agrosavfe.com
Sofinnova Partners Announces the Sale of Breath Therapeutics to Zambon
Italian pharma company purchases Breath Therapeutics for up to €500 million, with €140 million up front
PARIS, France, July 25, 2019 – Sofinnova Partners, a leading European venture capital firm specialized in the life sciences, today announced that Zambon is acquiring its portfolio company Breath Therapeutics, which specializes in advanced and first-in-class inhalation therapies for severe respiratory diseases. Zambon, an Italian pharmaceutical firm, will pay up to €500 million in this acquisition. Independent strategic healthcare advisor Leopoldo Zambeletti advised Breath Therapeutics on this sale. Sofinnova Partners exits Breath Therapeutics after a holding period of two and a half years.
Breath Therapeutics was founded by Dr. Jens Stegemann, Dr. Oliver Denk, Dr. Gerhard Boerner and Anne Burger, who serve respectively as Chief Executive Officer, Chief Operating Officer, Chief Scientific Officer and Chief Financial Officer. Sofinnova Partners co-led Breath Therapeutics' €43.5 million Series A financing with Gimv. Gilde also participated in the investment. Sofinnova Partners helped appoint Dr. Noreen Henig as Chief Medical Officer. Dr. Henig previously served as Chief Medical Officer for ProQR Therapeutics, another Sofinnova Partners portfolio company. Breath Therapeutics' team will continue to play a key operational role post acquisition.
Breath Therapeutics' drug device platform consists of a proprietary liposomal cyclosporine A for inhaled drug delivery with eFlowⓇ nebulizer technology from PARI Pharma. The lead product candidate, L-CsA-i, has currently started two global phase 3 clinical studies for treatment of bronchiolitis obliterans syndrome (BOS) post-lung transplantation, a fatal respiratory orphan disease with no therapies approved.
Graziano Seghezzi, Managing Partner at Sofinnova Partners and Breath Therapeutics' Board Member, said: "Breath Therapeutics is a perfect symbol of our investment strategy: cutting-edge platform and products developed by brilliant entrepreneurs for a debilitating disease with no effective treatment. We had a clear vision in mind for a transatlantic operation with strong bases in Europe and in the U.S. to maximize the commercial opportunity. We've achieved that vision and assembled a stellar management team by complementing the founders' European skills with deep U.S. clinical, regulatory and commercial expertise."
Breath Therapeutics´ Chief Executive Officer Dr. Stegemann said, "Sofinnova Partners played an instrumental role in getting our company through its first years and early expansion. We're thrilled with how successful we have moved forward the developed of our lead drug L-CsA-i and how quickly the company has grown, and now looking forward to moving into a new dimension via the Zambon acquisition."
Zambon is a Milan-based pharmaceutical group initially founded in 1906. It specializes in finding treatments for serious diseases lacking cures, such as respiratory illnesses, Parkinson's Disease and cystic fibrosis.
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together a team of professionals from all over Europe, the U.S. and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners invests across the Life Sciences value chain as a lead or cornerstone investor, from very early stage opportunities to late stage/public companies. It has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €2 billion under management.
About Breath Therapeutics
Founded in 2016, Breath Therapeutics is a private, venture-backed clinical stage biopharmaceutical company specializing in advanced inhaled therapeutics for severe respiratory diseases with high unmet medical need. The company's proprietary drug formulations have been specifically designed for inhaled administration with exclusively licensed, high performance nebulizer technology. L-CsA-i, Breath Therapeutics' lead asset, is advancing as the first therapy for BOS, a rare and devastating lung disease with no currently available treatment. Breath Therapeutics has offices in Munich, Germany and Menlo Park, CA. For more information, please visit https://breath-therapeutics.com/
About Zambon
Zambon is a multinational pharmaceutical and fine-chemical company that focuses on innovation and development with the aim to improve the quality of people's health and patients' lives. Based on a valuable heritage but strongly focused on the future, its goal is to improve people's health through the development of innovative and quality medicines. Zambon products are commercialized in 86 countries. The company has 20 subsidiaries in three different Continents – Europe, America and Asia – and owns manufacturing units in Italy, Switzerland, France, China and Brazil. The company today has a strong focus on the treatment of rare diseases and specialties, such as Parkinson's disease and Cystic Fibrosis, and it's well-established in 3 therapeutic areas: respiratory, pain and women's care. Zambon was established in 1906 in Italy and today counts around 2,700 employees all over the world. For details on Zambon, please visit www.zambon.com
Press contact for Sofinnova Partners
Marion Janic
mjanic@rooneyco.com
AgroSavfe appoints Patrice Sellès as new Chief Executive Officer and further strengthens leadership team
• Patrice brings over 20 years of leadership experience in the Food and Crop Protection sector
• Luc Maertens appointed Chief Operations Officer
• Significantly strengthened AgroSavfe's leadership team to further support accelerated growth of the Company
GHENT, Belgium, July 02, 2019 — AgroSavfe NV, a rapidly growing and transformative AgTech company developing next generation AGROBODY™-based biocontrols, today announces the appointment of Patrice Sellès as new Chief Executive Officer (CEO). In addition, Luc Maertens has been appointed Chief Operations Officer (COO).
Patrice joins AgroSavfe from Syngenta, a leading agriculture company, where he spent more than 17 years in various international executive leadership and scientific positions, as Global Head R&D Strategic Portfolio and Performance, but also as venture investment manager. Patrice held his positions both in Europe and in the US.
Building on the proprietary AGROBODY Foundry™ Platform, Luc Maertens will head the full development of the rapidly expanding proprietary product pipeline as Chief Operations Officer. In this position, Luc will lead the coordination and execution of the Company's programs from product design through to development and regulatory submissions as well as the commercial scale manufacturing.
Lieven De Smedt, Chairman of the Board of Directors, commented: "We are very pleased that Patrice is joining us as new CEO to bring AgroSavfe to the next level in the international markets. He thoroughly understands the Agro Industry dynamics thanks to his 20-year track record in various leadership roles, including portfolio and investment strategy development and execution, and business development. His expertise will be invaluable as we enter an important new phase and are starting to prepare the launch of our first product, expected in 2022."
Patrice Sellès, CEO of AgroSavfe, said: "I am thrilled to have been offered the opportunity to lead AgroSafve at this important stage. Over the past few years, the team has de-risked a unique technology platform and developed a promising pipeline and I am excited to build on this success with our fantastic team in Ghent. I look forward to engaging with our stakeholders and supporting the company in becoming a strong and substantial business for the long term, addressing the many challenges currently facing worldwide agriculture and food production."
The growing demand for healthy, safe and sustainable food has increasingly imposed restrictions on agricultural practices. Therefore, improving food production efficiency in a sustainable way, while safeguarding the environment and its natural resources, is essential.
AgroSavfe has the ambition to contribute to a sustainable production of safe and healthy food. The Company is focused on the discovery, development and commercialization of effective and safe biocontrols to tackle plant pests and diseases using its ground-breaking, scalable, proprietary AGROBODY Foundry™ Platform.
Corporate Communications & Investor Relations
Marieke Vermeersch, M.V.LifeSci Consulting for AgroSavfe
Labiotech.eu – The Business of Biotech: What to Do When the S*#t Hits the Fan – Antoine Papiernik
The Business of Biotech: What to Do When the S*#t Hits the Fan
Comet Bio Completes Equity Financing and Opens U.S. Headquarters in Chicagoland Area
SCHAUMBURG, IL – July 16, 2019 – Comet Bio, a manufacturer of healthy and sustainable ingredients, has closed a round of financing with its current investors. The equity funding allows the company to commercialize its flagship products, Arabinoxylan Plant Fiber Extract and SweeterraTM syrups, both of which are made from crop leaves and stalks left over after a farm's harvest. Existing investors Sofinnova Partners and PM Equity Partner participated in the financing.
"Our products are in high demand because they address consumers' interest in gut health and sugar reduction," said Comet Bio CEO Rich Troyer. "We are pleased to have the ongoing support and confidence of our investors to successfully bring these products to market."
Comet Bio will use the funds to deepen their partnerships to serve food and beverage customers, launch supplement and health food products, complete additional clinical trials to further establish the healthy features of the company's products, and expand its supply chain to meet increasing customer demands. The company has also established their U.S. headquarters in Chicago, IL. Their offices, located at 1501 Perimeter Drive in Schaumburg, will house the company's administrative and commercial functions. Comet Bio chose Chicago for its U.S. headquarters because of the significant number of food and nutrition companies located throughout the region.
"Consumers are demanding products that are healthy and good for the environment without compromising on taste. A big obstacle for food and beverage companies has been swapping ingredients without sacrificing taste and performance. Comet's innovative ingredients finally provide food and beverage companies a no compromise solution to meet consumer needs." said Joško Bobanović of Sofinnova Partners. "We have been impressed by Comet's ability to identify new applications in high demand and look forward to supporting the Comet management team as they commercialize these exciting new products."
"Comet Bio is now well positioned to introduce its healthy ingredients in an appealing range of applications," said Marco Brunazzo of PM Equity Partner. "Comet's products are ideal for supplements and nutritional products, as well as confectionary, fruit preparations and beverages."
Comet Bio produces healthy ingredients from crop leftovers for use in supplements, foods and beverages. The company's Arabinoxylan Plant Fiber Extract is a prebiotic dietary fiber that supports gut health, and a healthy metabolism, while it's SweeterraTM syrups are functionally equivalent to traditional sweeteners, and are more sustainable, lower in calories and sugar, and higher in fiber. By upcycling crop leftovers, the company helps farmers utilize their whole harvest, which results in products that are better for the planet. According to an independent well-to-wheel Lifecycle Carbon Emissions Assessment (LCEA), Comet's ingredients reduce greenhouse gases by over 60% compared to traditional sweeteners. In addition, independent tests confirm that Comet's products perform the same as traditional ingredients in many product applications including confectionary, fruit preparations and baking.
About Comet Bio
Comet Bio is a manufacturer of award-winning healthy and sustainable ingredients based in London, Ontario and Schaumburg, Illinois. The company upcycles crop leftovers into healthy and sustainable ingredients for use in supplements, foods, and beverages. The company's two flagship products are Sweeterra™ syrup blends and Arabinoxylan dietary fiber that are natural and healthy without compromising on taste or performance. Their ingredients are better for the planet because they reduce greenhouse gases and help farmers take advantage of their whole harvest. For more information, visit http://comet-bio.com/ and follow us on Twitter at @cometbio.
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together a team of professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a lead or cornerstone investor from very early stage opportunities to late stage/public companies. It has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €2.0 billion under management. For more information, please visit: www.sofinnovapartners.com
About PM Equity Partner
PM Equity Partner invest in entrepreneurs and growth companies that share their vision of profitable sustainability and sustainable profitability. As a long-term investment partner their support includes scientific substantiation, business development and marketing excellence PM Equity Partner is the corporate venture capital and private equity investment arm of Philip Morris International (NYSE:PM).
Matthew Hargarten
matthew@rival-communications.com
ABIVAX Completes €12 Million Capital Raise Entirely Subscribed by Sofinnova Partners at Market Price
Abivax cash runway extended to end of Q2, 2020
Sofinnova Partners strengthens and diversifies Abivax shareholder base
Sofinnova Partners to join the Board of Directors
Proceeds to be used for funding advanced stage clinical trials in inflammation and oncology
Paris, France, 11 July 2019 at 07:30 pm – ABIVAX SA (the "Company" or "ABIVAX") (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announced today the successful completion of a capital increase of 1,500,000 new ordinary shares with a nominal value of €0.01 per share (the "Transaction"), which has been entirely subscribed at market price by Sofinnova Crossover I, a fund managed by Sofinnova Partners ("Sofinnova").
"Sofinnova Partners is globally recognized as a leading specialist investor and their investment, combined with the continued support of our founding shareholder, Truffle Capital, not only validates our science and strategy but also extends our cash runway to the end of the second quarter of 2020," said Prof. Hartmut J. Ehrlich, MD, CEO of Abivax. "Abivax now has sufficient time and resources to leverage maximum value in ongoing partnering discussions for ABX464, while also providing funding to achieve important value-creating milestones in three phase 2 trials of ABX464 in ulcerative colitis, rheumatoid arthritis and Crohn's disease and one phase 1/2 trial of ABX196 in liver cancer."
"We are pleased to become investors in Abivax. We have followed Abivax's continuing progress and determined that its assets and management have the potential to create significant value for patients, corporate partners and Abivax shareholders," said Kinam Hong, MD, Partner at Sofinnova Partners.
"We are particularly motivated by the strong anti-inflammatory properties and proof of concept demonstrated to date by ABX464 and its broad potential to address multiple diseases where patients are not adequately treated by existing therapies."
Philippe Pouletty, MD, Chairman of the Board of Abivax and CEO of Truffle Capital commented: "We are delighted to work with Sofinnova, which shares many of our values, to help further guide Abivax to clinical and corporate success."
Net proceeds of €12 million provide the Company with additional funding to implement its strategy, conduct its operations and reinforce its financial structure. In particular, funding will be primarily allocated to finance the next steps in the clinical development of its lead product, ABX464, including a Phase 2b study in ulcerative colitis and Phase 2a studies in rheumatoid arthritis and Crohn's disease. Secondarily, the funds will also be used for next steps in the clinical development of ABX196 to treat hepatocellular cancer in the U.S.
In the framework of the Transaction, the Company agreed that Sofinnova, as a new major financial partner for Abivax, will present a candidate for appointment to the Company's Board of Directors (Conseil d'Administration) in replacement of Dr. Claude Bertrand, who resigned from his office as director of the Company.
Key features of the Capital Increase
The New Shares were issued through a capital increase without shareholders' pre-emptive rights reserved to a specified category of investors under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to the 14th resolution of the Annual General Shareholders' Meeting held on 7 June 2019. The Company explored various equity funding options prior to entering into the Transaction with Sofinnova, which best matched the Company's financing needs. The Company's intentions with regards to potential future partnerships remain unchanged.
The number of ordinary shares subscribed (the "New Shares") and the subscription price were decided by the Company's Chief Executive Officer (Directeur Général), in accordance with a sub-delegation granted by the Company's Board of Directors (Conseil d'Administration) on 9 July 2019.
Sofinnova subscribed to 1,500,000 New Shares with a par value of €0.01, at a price of €8.00 per New Share, including share premium, for a total subscribed amount of €12,000,000, representing approximately 12.7% of the share capital of the Company.
Payment and delivery of the New Shares is expected to occur on or about 15 July 2019.
The New Shares were issued with no discount to the closing price of the Company's shares on the regulated market of Euronext Paris as at 9 July 2019.
As of the settlement and delivery date, which is expected to occur on 15 July 2019, the New Shares will be fungible with the Company's existing shares and are entitled to current dividend rights. The New Shares will be listed on Euronext Paris under ISIN FR0012333284 on 15 July 2019.
The issuance of the New Shares will have the following impact on the allocation of the share capital and the voting rights of the Company:
Financial update
The Company confirms that, in its view, following the issuance of the New Shares and taking into account (i) the €10 million raised by the Company as a result of the draw of the second tranche of the Kreos financing which took place on 31 May 2019, and (ii) other financial sources available to the Company such as the equity line with Kepler Cheuvreux, the Company will have the financial resources required to cover its net working capital needs over the next 12 months. The Company has no immediate intention to draw on the Kepler Cheuvreux equity line. Since the beginning of this agreement in September 2017, out of 970,000 shares available, Kepler Cheuvreux exercised 200,000 shares (2.0% of the current total shares of Abivax) until June 2019. The primary terms and conditions of the Kreos financing were set forth in the press release issued by the Company, dated 25 July 2018. The second tranche of the Kreos financing is composed of 8 million straight bonds with a nominal value of 1 euro each and 2 million of co vertible bonds with a nominal value of 1 euro each. The conversion price for the convertible bonds is €10.70 corresponding to the potential issuance of 186,916 new shares.
As part of the second tranche, ABIVAX has also issued warrants to Kreos Capital, giving it the right to subscribe up to €800,000 into new shares of ABIVAX at a nominal value of €0.01 and a subscription price identical to the conversion price of the convertible bonds for the second tranche.
The Kreos financing is an unsubordinated and first rank debt financing and is secured by pledges over ABIVAX's tangible and intangible assets, including all the Company's intellectual property rights over its drug candidates.
About ABX464
ABX464 was shown to target the cap binding complex (CBC), which is a novel mechanism of action for anti-inflammatory drugs. By binding to the CBC, ABX464 reinforces the biological functions of this complex in cellular RNA biogenesis including splicing. ABX464 enhances the selective splicing of a single long non-coding RNA to generate the anti-inflammatory miR-124, which acts by downregulating proinflammatory cyto- and chemokines like TNF-, Il-6 and MCP-1, thereby putting a brake on inflammation. A seven- to ten-fold increase of miR124 was observed in peripheral blood mononuclear cells (PBMCs), and in colorectal biopsies of UC patients treated with ABX464.
ABX464 in Ulcerative Colitis
Following the exciting results of the Phase 2a proof-of-concept study in ulcerative colitis, Abivax is launching a randomized, double-blind, placebo-controlled, dose-ranging Phase 2b trial (link to ClinicalTrials.gov) in 232 UC patients that will have four arms: three escalating doses of once-daily oral ABX464 (25 mg/day, 50 mg/day and 100 mg/day) and placebo. The study will be conducted in up to 150 study sites in more than 17 countries under the leadership of its steering committee (Prof. Severine Vermeire, M.D., Ph.D., Prof. Herbert Tilg, M.D. Ph.D., Prof. Xavier Hebuterne, M.D., Ph.D., and Prof. William Sandborn, M.D.), and includes an eight week induction phase followed by an open-label maintenance study with ABX464. The primary endpoint is reduction in modified Mayo Score at 8 weeks, and secondary endpoints will include clinical remission, endoscopic improvement and biomarker fecal calprotectin. Full regulatory and ethics approvals have already been granted in several European countries and in Canada, ith first patient enrollment expected in late July/early August of this year and top-level results expected around the end of 2020.
ABX464 in Rheumatoid Arthritis
Abivax is also launching a phase 2a proof-of-concept study designed to evaluate the safety, tolerability and preliminary efficacy of two oral dose-levels of ABX464 administered daily, in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX and/or to one or more anti-tumor necrosis factor alpha (TNFα) biologicals. This is a randomized, double-blind, placebo-controlled, multicenter study in sixty patients with moderate to severe active RA, who will be assigned to receive 50mg ABX464, 100mg ABX464 or placebo during the twelve-week treatment phase. The primary endpoint of the study will be safety and tolerability. Secondary endpoints will be indicators of efficacy including the change from baseline in the individual components of the American College of Rheumatology (ACR), the proportion of patients achieving ACR20 response and change from baseline in Disease Activity Scores (DAS) in 28 joints. For further details, please lick here. The first patient is expected to be enrolled in late July/early August of 2019 and top-level results expected during summertime 2020.
ABX464 in Crohn's Disease
Abivax is also preparing an international phase 2a clinical study of ABX464 in 30 patients with Crohn's disease ( link to ClinicalTrials.gov). This study is scheduled to start enrolling patients around the end of this year.
ABX464 in other Inflammatory Diseases
The inflammatory disease space represents an area of high unmet medical need, and a corresponding substantial market opportunity. It is estimated that nearly 1 million patients with ulcerative colitis live in the US, 650,000 in Europe, and over 2.7 million patients globally, representing a potential market opportunity of up to $5.5 billion annually, based on 2017 pharmaceutical sales in this sector. For IBD (UC and Crohn's disease), pharmaceutical sales during this same period are estimated to have reached $15 billion1. The market potential for the full range of inflammatory conditions (including neuroinflammatory diseases) is currently estimated to be in excess of $70 billion, a market and patient population that the Company believes could benefit from ABX464. Therefore, Abivax is currently conducting preclinical proof-of-concept studies in multiple sclerosis, Parkinson's disease, Psoriasis, NASH and pulmonary arterial hypertension.
ABX464 in HIV
The results of the ABX464-004 and ABX464-005 studies, showing that ABX464 reduced HIV-viral reservoirs in the blood as well as in rectal tissue, make it a promising therapeutic candidate for a phase 2b study. However, given the complexity of the US and European regulatory processes to develop an HIV cure, in view of the opportunities Abivax has in the inflammatory space, the company decided to conduct the next steps of development of ABX464 in HIV through investigator-initiated clinical studies with third party and/or public funding. The first such study is scheduled to be initiated by the end of 2019.
ABX196 in Liver Cancer
US FDA recently accepted an investigational new drug (IND) application for ABX196, which showed potent efficacy in HCC animal models. ABX196 is a synthetic glycolipid agonist of invariant Natural Killer T cells (iNKT) in a liposomal formulation. A phase 1 clinical trial conducted by Abivax in healthy volunteers has been completed and demonstrated safety and tolerability as well as potent activation of iNKT cells. Preclinical studies have demonstrated the potential of ABX196 for cancer therapy:
ABX196, both alone and in combination with a checkpoint inhibitor, showed a statistically highly significant therapeutic effect in reducing tumor growth as measured by MRI and increasing survival in mice with HCC. Abivax holds exclusive rights to ABX196 from Scripps Research, the University of Chicago, and Brigham Young University. The open IND allows Abivax to test ABX196 in combination with nivolumab (Opdivo®, Bristol Myers Squibb), a checkpoint inhibitor, in a first Phase 1/2 clinical trial to treat patients with HCC. The initial dose-escalation phase of the study will be conducted at the Scripps MD Anderson Cancer Center in San Diego, CA, USA; additional leading cancer centers in the US will be involved in the subsequent expansion phase of the study. The first patient is expected to be enrolled in August of 2019 and top-level results of the first study phase (escalation phase) during summertime 2020.
Information disclosed to the public
The 2018 registration document (document de référence) of the Company, filed with the French Autorité des Marchés Financiers ("AMF") on April 29, 2019 is available free of charge on the Company's website (www.abivax.com). Attention is drawn to the risk factors related to the Company and its activities presented in chapter 4 of its registration document.
An update of the Company's corporate presentation, dated June 2019, with a presentation of the Company's activities, including the progress of preclinical and clinical programs, is available on the Company's website.
This press release does not constitute a prospectus within the meaning of the Prospectus Directive nor a public offering.
Dechert LLP acted as legal advisor to Abivax on this transaction.
Abivax
Pierre Courteille
pierre.courteille@abivax.com
Press Relations USA
Rooney Partners LLC
Chris Maggos
chris@lifesciadvisors.com
Press Relations France
Actifin
Ghislaine Gasparetto
ggaspartetto@actifin.fr
Press Relations and Investors
MC Services AG
Anne Hennecke
anne.hennecke@mc-services.eu
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together a team of professionals from all over Europe, the U.S. and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners invests across the Life Sciences value chain as a lead or cornerstone investor, from very early stage opportunities to late stage/public companies. It has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €2 billion under management. For more information, please visit: www.sofinnovapartners.com.
This document and the information contained herein do not constitute either an offer to sell or purchase, or the solicitation of an offer to sell or purchase, securities of the Company.
This announcement does not, and shall not, in any circumstances, constitute a public offering nor an invitation to the public in connection with any offer. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.
This announcement is an advertisement and not a prospectus within the meaning of the Prospectus Directive (as defined below), as implemented in each member State of the European Economic Area.
The Transaction does not constitute a public offering in France as defined in Article L.411-1 of the French Monetary and financial code and Article 2(1)(d) of the Prospectus Directive. With respect to the Member States of the European Economic Area (including France) ("Member States"), no action has been undertaken or will be undertaken to make an offer to the public of the securities referred to herein requiring a publication of a prospectus in any Member State.
For the purposes of the provision above, the expression "offer to the public" in relation to any shares of the Company in any Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any securities to be offered so as to enable an investor to decide to purchase any securities, as the same may be varied in that Member State. The expression "Prospectus Directive" means Directive 2003/71/EC, as amended, and includes any relevant implementing measure in the Member State.
This document does not constitute an offer of securities for sale nor the solicitation of an offer to purchase securities in the United States or in any other jurisdiction where such offer may be restricted. Securities may not be offered or sold in the United States or to U.S. persons (as defined below), absent registration under the U.S. Securities Act of 1933, as amended (the "Securities Act"), except pursuant to an exemption from, or in a transaction not subject to the registration requirements thereof. The securities of the Company have not been and will not be registered under the Securities Act, and the Company does not intend to make a public offer of its securities in the United States.
AblaCare Announces Series A Financing of €10 Million by Sofinnova Partners for Innovative Infertility Treatment and Appoints Jodie Fam as CEO Funds to Support European Feasibility Study for Device Designed to Restore Ovulation in Women with Infertility Related to Polycystic Ovary Syndrome
PARIS — July 9, 2019 — AblaCare, a medical device company dedicated to transforming women's health and fertility care, announced today that it has raised €10 million in Series A financing from Sofinnova Partners. The company also announced the appointment of seasoned medical device executive Jodie Fam as CEO.
AblaCare's treatment, a minimally invasive procedure called "ovarian rebalancing," uses ablation to restore ovulation in women with infertility related to polycystic ovary syndrome (PCOS). This new technology transforms an older, invasive surgical method, called "ovarian drilling," into a minimally invasive and much simpler office-based procedure. Ablation of ovarian tissue eliminates excess androgen-producing tissue in the ovary. Following this one-time treatment, spontaneous ovulation occurs in up to 75% of women within six months, with up to 55% of women achieving pregnancy in the same timeframe,1 with a natural conception experience.
As CEO, Fam brings more than 20 years of medical device experience leading early stage medical device product development, market access and commercialization for major medtech companies and several venture-backed startups. She has held top management roles at Concentric Medical (acquired by Stryker), Medina Medical (acquired by Medtronic) and CardioKinetix, as well as senior sales and marketing positions with Johnson & Johnson, Guidant Corporation and Mallinckrodt Medical.
"We're pleased to become investors in AblaCare's Series A financing. We believe the company has the right technology to address one of the primary causes of infertility," said Antoine Papiernik, Managing Partner at Sofinnova Partners. "In addition, we are thrilled to have Jodie leading the AblaCare team. She has been instrumental in bringing a number of early-stage, paradigm-shifting medical technologies to market in diverse and competitive environments." Up to 15% of women are diagnosed with PCOS, half of which face infertility.2 The condition is caused by the overproduction of male hormones, which prevents the development and release of mature eggs. Current treatment options are complex, costly and emotionally trying.
"AblaCare addresses the number-one cause of ovulation-related infertility, allowing women with PCOS to ovulate as they naturally would—without using fertility medications and hormones," said Fam. "We are proud that a premier life sciences investor recognizes the enormous opportunity AblaCare represents to transform innovations for women's health." Proceeds from the financing will be used to advance the company's clinical and regulatory programs in Europe and the United States. Concurrent with the financing, Andrew Weiss, President and CEO at ReCor Medical, has been named chairman of the board of directors for AblaCare.
About AblaCare
AblaCare is a medical device company offering a minimally invasive ablation technology designed to restore ovulation in women with infertility related to polycystic ovary syndrome (PCOS). AblaCare's "ovarian rebalancing" procedure is designed to help the body to ovulate as it naturally would through a one-time intervention performed in the medical clinic. It is currently being evaluated in the ULTRA clinical trial (clinicaltrials.gov: NCT03760926). AblaCare was created, seeded and incubated by MD Start II and participated in the selective MedTech Innovator Accelerator program. The company is headquartered in Paris. For more information, visit www.AblaCare.com
Deb Franko
Health+Commerce
deb@healthandcommerce.com
DMC Biotechnologies, Inc. Announces First Close of $10.3M Series A Financing Led by Sofinnova Partners
[Boulder, CO] July 9, 2019 – DMC (www.dmcbio.com), an early-stage biotechnology company, announced today that is has raised a Series A equity financing led by Sofinnova Partners. The company also announced the addition to its Board of Directors of Josko Bobanovic, Partner and Manager of the Sofinnova Industrial Biotech Fund. Current investors Capricorn Venture Partners and Breakthrough Energy Ventures also participated in the fundraise. This funding builds on the company's successful non-dilutive awards to date which exceed $1.8M from the National Science Foundation, the US Department of Energy, and the US Department of Agriculture.
DMC makes bio-based products using enhanced microbial fermentation. The development of microbes and associated bioprocesses has historically been complicated, slow, and costly. DMC is deploying its technology to reduce biological complexity and enhance the speed of development, creating a low cost, fermentation-based manufacturing platform that has the capability to produce a broad diversity of products. The company's platform enables low cost distributed manufacturing of existing products and new-to-the world products that are only accessible using the precision of biology.
Josko Bobanovic, Partner at Sofinnova Partners and the manager of the Sofinnova Industrial Biotechnology Fund, said: "We have been impressed by a unique technology, an exceptional founding team, and significant potential for rapid commercial growth. This funding round brings together like-minded investors who share the team's vision of creating a capital efficient, multi-product, biochemicals company."
"We are excited that Sofinnova appreciates the potential of our proven technology and shares our vision of the commercial path for the company. We look forward to working with them as we bring our specialty amino acids product family into the marketplace and as we continue to build our robust product pipeline," said Matt Lipscomb, Ph.D., CEO and Co-Founder of DMC.
Rob van der Meij, Senior Investment Manager at Capricorn Venture Partners (the manager of the Capricorn Sustainable Chemistry Fund), and Board member of DMC, added: "We are continuing to invest in DMC because their approach and technology are differentiated in the sector and they have demonstrated strong progress the past 1.5 years. We look forward to working with Sofinnova and the DMC team to support the company's commercial efforts across multiple global markets."
Carmichael Roberts, of Breakthrough Energy Ventures stated "DMC's synthetic biology platform has the potential to transform traditional product and chemical development by dramatically reducing time-to-market and costs. The technical implications of DMC's science in the fuels and food sectors drew us to the company and we are excited to be part of their journey."
With this funding, DMC plans to recruit additional top talent in senior management, metabolic engineering, and fermentation for locations in Boulder, CO and Durham NC as it advances its first products to commercial scale.
DMC is unleashing the manufacturing power of biology. The company is democratizing metabolic engineering and bioprocess development to accelerate commercial deployment of sustainable bio-based products across multiple markets. The company's lead product family will provide ingredients for the
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animal and human nutrition markets. In addition, pipeline product families in development by DMC will address unmet customer needs in sectors that include specialty chemicals, flavors and fragrances, and personal care.
For more information, visit: www.dmcbio.com
Capricorn Venture Partners, an independent Leuven (Belgium) based manager of venture capital and equity funds, invests in innovative companies with technology as a competitive advantage. It operates under an AIFM license granted by the FSMA (the Financial Services and Markets Authority in Belgium). The investment in DMC is made from the Capricorn Sustainable Chemistry Fund.
For more information, please visit: http://www.capricorn.be/
About Breakthrough Energy Ventures
Breakthrough Energy Ventures (BEV) invests in companies that leverage innovative technologies to help address climate change. Backed by many of the world's top business leaders, BEV has more than $1 billion in committed capital to support bold entrepreneurs building companies that can significantly reduce emissions from agriculture, buildings, electricity, manufacturing, and transportation. The fund was created in 2016 by the Breakthrough Energy Coalition.
Visit www.b-t.energy.com to learn more.