MinervaX announces 72M EUR financing to advance development of novel vaccine against Group B Streptococcus
- Financing from new investors Trill Impact Ventures and Pureos Bioventures as well as existing investors
- Backing from European Investment Bank
- Planning for Phase 3 clinical development of novel GBS vaccine
Copenhagen, Denmark, 15 December 2022 – MinervaX ApS, a privately held Danish biotechnology company developing a novel vaccine against Group B Streptococcus (GBS), today announces the successful completion of a 72 million EUR financing round. The equity financing of 22 million EUR was co-led by new investors Trill Impact Ventures and Pureos Bioventures and includes existing investors REPAIR Impact Fund (Novo Holdings), Sunstone Life Science Ventures, LF Investment, Wellington Partners, Sanofi Ventures, Adjuvant Capital and Industrifonden. In addition to the equity financing, the European Investment Bank provided a 50 million EUR loan facility.
MinervaX has had an exciting year of clinical development for its novel GBS vaccine. The Company commenced enrolment of pregnant women in its Phase 2 clinical trial in Denmark, the UK, and South Africa and completed the dosing of healthy adult women, previously dosed with its GBS vaccine, in a Phase 1 booster clinical trial in the UK.
The financing will enable MinervaX to advance the late-stage development of its GBS vaccine candidate in preparation for a Phase 3 clinical trial. The vaccine candidate was recently awarded PRIME status by the European Medicines Agency (EMA) due to its potential to prevent life-threatening infections in newborn babies. MinervaX also aims to expand its clinical development team and evaluate the Phase 2 clinical data for efficacy and safety ahead of publication next year.
Per Fischer, Chief Executive Officer of MinervaX, said: “We are delighted to announce this financing, which gives us the firepower to accelerate the development of our novel GBS vaccine. GBS can be life-threatening for newborn babies and there is no approved, universally available vaccine to date. I would like to thank the investors and the MinervaX team who have worked very hard on our vaccine candidate in preparation for
the final stage of clinical development.”
In conjunction with the financing, Bita Sehat, Senior Director at Trill Impact Ventures, and Veronica Gambillara, Partner of Pureos Bioventures, will join the Board of Directors.
Veronica Gambillara, Partner at Pureos Bioventures, commented: “We are excited to join the MinervaX team and support the development of this vaccine which could protect against one of the leading causes of neonatal and infant sepsis. We are impressed with the clinical data previously generated and the dedication of the leadership team. This financing will expedite the development of a product that has the potential to drastically improve the options available to address GBS infections.”
Bita Sehat, Senior Investment Director at Trill Impact Ventures, added: “MinervaX’s GBS vaccine holds great promise to address a large unmet medical need globally by preventing serious infections in both newborns and pregnant women. Its successful development will not only save lives, it will also contribute to combatting antimicrobial resistance. We are happy to join forces with a strong shareholder base and an excellent management team to support turning this promise into reality. We view MinervaX as a great example of societal and commercial impact going hand in hand.”
EIB Vice president Christian Thomsen, responsible for Denmark, added: “We are delighted to be supporting MinervaX with its medical research into the unmet medical need. Being one of the biggest financiers of innovation in Europe, this fits our investment strategy; to support highly innovative biotech companies developing breakthrough Life Science products, which have the potential to transform and improve people’s lives.”
Details of MinervaX’s clinical trials can be found at clinicaltrials.gov under the identifiers NCT04596878, NCT05154578 and NCT05005247.
Forfurther information please contact:
MinervaX
Per Fischer | Chief Executive Officer
Email :
Optimum Strategic Communications
Mary Clark / Manel Mateus / Richard Staines/ Zoe Bolt
Email:
Tel: +44 (0) 203 882 9621
Notes to Editors:
About MinervaX
MinervaX is a Danish biotechnology company, established in 2010 to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. MinervaX is developing a GBS vaccine for maternal immunization, likely to have superior characteristics compared with other GBS vaccine candidates in development. The latter are based on traditional capsular polysaccharide (CPS) conjugate technology. By contrast, MinervaX’s vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS (the Alpha-like protein family). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX’s vaccine will confer protection against virtually 100% of all GBS isolates. www.minervax.com
About Group B Streptococcus (GBS)
GBS is responsible for nearly 50% of all life-threatening infections in newborns. At any given time, some 15-25% of women are spontaneously colonized with GBS, and they run the risk of transmitting the bacteria to their child in the womb, during birth and/or during the first months of life. GBS colonization may lead to late abortions, premature delivery, or stillbirth and, in the newborn child, may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long- term disability or death.
Currently, the only preventative strategy available involves the use of intravenously delivered prophylactic antibiotics which does not comprehensively prevent GBS infection in utero or protect against late-onset infection in newborns. Not only is this approach expensive and logistically challenging, it fails to cover all, including the most severe cases in the US and Europe, and is rarely available in resource- limited settings.
The development of a GBS vaccine is also endorsed by Group B Strep Support and Group B Strep International, and GBS has been prioritized by a number of public health organizations. Both increased uptake of immunization among pregnant women and greater awareness of the implications of GBS suggest that a safe and effective vaccine targeting GBS would be well suited to address this unmet need.
About Trill Impact
Trill Impact is a pioneering Impact House with EUR 1,2 billion in assets under management across its investment strategies. With a team of more than 35 experienced professionals based in the Nordics and Germany, Trill Impact aims to become a force for positive change and realize its vision of delivering real returns and lasting impact for the benefit of investors, businesses and society at large. For further information, please visit www.trillimpact.com
About Pureos Bioventures
Pureos Bioventures is venture capital fund advised by Swiss-based Pureos Partners that invests exclusively in private innovative drug development companies, with a special emphasis on the next generation of biological drugs and drug formats. The fund’s portfolio companies are built on scientific excellence to develop therapies across a broad indication spectrum including oncology, immunology, ophthalmology, rare diseases, and neuroscience. Pureos has built a team with in-depth investment, operating and clinical expertise, that strives to impact patients’ lives by advancing innovative treatments for devastating diseases. For further information, please visit www.pureosbio.com
About the European Investment Bank
The European Investment Bank (EIB) is the bank of the European Union, owned by the EU27 Member States. It is active in some 160 countries and is the world’s largest multilateral lender for climate action projects. The bank is providing long term financing for economically sustainable investments to contribute to the European Union’s political objectives. The EIB Group has set “ensuring a just transition for all” as one of the four overarching objectives in its Climate Bank Roadmap 2025. The EIB’s ambition is to support €1 trillion of climate action and environmental sustainability investments in the decade to 2030 and align all its new operations with the goals and principles of the Paris Agreement.
About InnovFIN-IDFF
The InnovFin Infectious Diseases Finance Facility (IDFF) provides financial products ranging from standard debt to equity-type financing for amounts typically between €7.5 million and €75 million to innovative players active in developing or manufacturing innovative vaccines, medicines, medical and diagnostic devices or novel research to combat infectious diseases. Project costs may include laboratory-validated technologies, which require clinical testing for further development, in addition to complementary pre-clinical research. The product is available directly through the European Investment Bank and will continue to support innovative infectious diseases projects until the end of 2022. For further information, please visit www.eib.org
TRiCares Successfully Closes Series C Financing, Raising €51m to Fund Further Development and Clinical Trials of Minimally Invasive Treatment for Tricuspid Regurgitation
TRiCares Successfully Closes Series C Financing, Raising €51m to Fund Further Development and Clinical Trials of Minimally Invasive Treatment for Tricuspid Regurgitation
TRiCares Successfully Closes Series C Financing, Raising €51m to Fund Further Development and Clinical Trials of Minimally Invasive Treatment for Tricuspid Regurgitation
Paris, France and Munich, Germany, December 6, 2022 – TRiCares SAS (“TRiCares”) a privately held pioneer in the field of minimally invasive treatment of tricuspid regurgitation, is pleased to announce today the second closing and completion of its Series C financing round, successfully raising a total of €51m for the round.
The proceeds of this financing will primarily be used to continue the development of the company’s transfemoral tricuspid heart valve replacement system (“Topaz”) up through to the application for a pivotal investigational device exemption (“IDE”) trial in the United States. To this end, TRiCares plans to initiate an early feasibility study across five centers in the US and Canada in 2023.
The proceeds of this financing will also support the on-going TRICURE first-in-human clinical study in Belgium as well as potential additional clinical trial applications elsewhere in Europe, along with further compassionate use implantations as appropriate.
The Series C financing was led by 415 Capital and joined by Bayern Kapital, the venture/growth capital company of the State of Bavaria in Germany, with strong support from existing investors Andera Partners, BioMed Partners, Credit Mutuel Innovation, GOCapital, Karista and Wellington Partners. Total gross proceeds were €51m.
TRiCares is developing a transcatheter-based tricuspid valve replacement system aimed at addressing the need for a better treatment for this frequent and severe disease that avoids open heart surgery. Heart valve diseases are among the most serious cardiac conditions, affecting more than 12.7 million patients in Europe and many more worldwide. Owing to high mortality risk, access to open heart surgery is severely restricted and is not considered an option for more than 99% of patients with tricuspid regurgitation, leaving surgeons seeking minimally invasive, lower risk solutions to improve outcomes for patients with no other viable treatment options.
Topaz is an innovative device developed to help patients suffering from severe tricuspid regurgitation without the need for open heart surgery. The Topaz device is implanted in a minimally invasive procedure through the patient’s femoral vein. It is designed specifically to fit the tricuspid valve anatomy and thus supports ease of positioning and functionality.
Helmut J. Straubinger, Chief Executive Officer of TRiCares, said: “Millions of patients with tricuspid regurgitation have no effective long-term treatment option, and their prognosis is very poor. The Topaz tricuspid valve replacement system is being developed with the aim of delivering a much-needed solution for these patients. With encouraging clinical signs, the strong support of world-class investors and our successful Series C financing, we look forward to the further development of the Topaz system with a focus on the necessary preparations for a pivotal IDE trial in the US along with the continued progress of our clinical activities in Europe.”
Dr. Georg Ried, Managing Director of Bayern Kapital, said: “Open heart tricuspid valve surgeries are among the riskiest curative procedures, with more than 99% of affected patients deemed unfit due to high mortality rates. With Topaz, TRiCares is developing an innovative product with excellent potential to fill this major gap in the treatment of valvular heart disease. We are very pleased to support TRiCares on its further course towards market approval.”
Frederik Groenewegen, General Partner at 415 Capital, commented: “We believe that the technology developed by TRiCares has the potential to establish itself as the gold standard in the treatment of patients with tricuspid regurgitation and to restore the quality of life of millions of patients in the long term. We are impressed with the initial clinical cases with the Topaz system and look forward to helping the team bring this novel therapy to patients in the U.S. and Europe.”
-ends-
About TRiCares
TRiCares is a young medical device startup company located in Paris and Munich having the vision to bring to the market a transfemoral tricuspid valve replacement system. This system aims at helping patients suffering from severe tricuspid regurgitation (TR) without the need for open heart surgery. The experienced team of TRiCares is supported by the leading European life science venture capital firms: Andera Partners, BioMed Partners, Credit Mutuel Innovation, GoCapital, Karista, Wellington Partners, 415 Capital and Bayern Kapital.
About Tricuspid Regurgitation (TR)
The tricuspid valve is the heart valve that regulates the blood flow between the right atrial and ventricular chamber. Tricuspid regurgitation occurs when the tricuspid valve fails to close properly, causing blood to flow backwards into the right atrium. Tricuspid regurgitation is a frequent problem and a severe disease that was neglected for many years, leading to a large number of untreated patients without an effective treatment option. Cardiac surgeons and interventional cardiologists have long waited for a transcatheter based solution. The progress in developing minimally invasive treatment options for heart valves as well as the experience gained in numerous research projects has strongly increased the awareness of the importance of this disease.
About the Medical Need
Heart valve diseases are among the most serious cardiac complications affecting at least 12.7 million patients in Europe and many more worldwide. In the last decade, innovative minimally invasive catheter-based solutions have been developed for the treatment of aortic and mitral heart valve disease, creating a fast-growing transcatheter heart valve replacement market. However, for patients with tricuspid heart valve disease (tricuspid regurgitation), no solution exists to replace the diseased heart valve due to anatomic, functional and technological challenges. Only repair options by so-called clipping devices have been developed. But this technique is not suitable for all patients and the treatment success is limited. Consequently, open-heart surgeries to repair the insufficient valve and medical treatments still represent the standard treatment options. Due to excessive risk of the procedures (10–35 % surgical mortality), more than 99 % of TR patients are considered ineligible for the curative surgeries and are only maintained on symptomatic pharmacologic treatment with poor prognosis (2.2 years median survival). Therefore, physicians are urgently seeking minimally invasive, low-risk solutions to improve clinical outcomes in TR patients.
For further information please contact:
TRiCares SAS
Helmut J. Straubinger,
President and Chief Executive Officer
Consilium Strategic Communications
Matthew Cole
T: +44 (0)20 3709 5700
ONWARD Reports Interim Clinical Outcomes for Implantable ARC Therapy Demonstrating Potential to Improve Blood Pressure Regulation after Spinal Cord Injury
ONWARD Reports Interim Clinical Outcomes for Implantable ARC Therapy Demonstrating Potential to Improve Blood Pressure Regulation after Spinal Cord Injury
Low blood pressure is a major issue for people with spinal cord injury that impacts
cardiovascular health and quality of life
ARC Therapy resulted in immediate improvement in blood pressure regulation in
all study participants
EINDHOVEN, the Netherlands, LAUSANNE, Switzerland, and BOSTON, MA USA—December
8, 2022–ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating
innovative therapies to restore movement, independence, and health in people with spinal cord
injury (SCI), today reported interim clinical outcomes from the first ten1 people treated to regulate
blood pressure with implantable ARC Therapy, ONWARD’s targeted spinal cord stimulation
technique. ARC Therapy immediately improved blood pressure levels for all participants; this
benefit has been sustained for the duration of the current follow-up period. Participants have also
reported improved quality of life, increased energy and vitality, and reduced dizziness.
Aaron Phillips, PhD, Associate Professor, Physiology and Pharmacology, Biomedical
Engineering, Cardiac Sciences, Clinical Neurosciences, Cumming School of Medicine, University
of Calgary, and the Principal Investigator of the HEMO study, said: “Low blood pressure has long
been a hidden complication of spinal cord injury that often goes unrecognized and leaves people
feeling unwell. It also potentially predisposes them to cardiovascular disease. The results reported
today with ARC Therapy are compelling and may open a new avenue to help people with spinal
cord injury truly feel better, while also addressing heart health.”
The interim outcomes reported today are from ten people with spinal cord injury who were treated
at clinical centers in Canada and Switzerland. In addition to a sustained increase in blood pressure
levels, participants who were taking an anti-hypotension drug prior to entering the study were able
to significantly reduce or discontinue their medication. Participants also reported improved
general well-being: Participants reported a reduction in orthostatic hypotension, including reduced
dizziness and improved energy, and those prone to fainting or light-headedness prior to implant
indicated that such incidents declined dramatically following treatment with ARC Therapy.
Participants continue to be followed, in one case for as long as three years, and the therapy
remains beneficial in all cases.
Dave Marver, CEO of ONWARD, said: “We are excited by these highly promising outcomes,
which reinforce our plan to further develop and bring ARC-IM to the market for this important
indication. Today, there are limited and ineffective options for treating people with low blood
pressure after spinal cord injury, and our therapy has the potential to address an issue that
significantly impacts their quality of life.”
1 A total of 10 people have received ARC Therapy across three studies: STIMO-HEMO, HEMO, and HemON, as well
as a clinical proof-of-concept, published in Nature in January 2021
2
Over 40% of people with spinal cord injury, or approximately 262,000 people in the U.S. and
Europe2
, are estimated to experience hypotension, or low blood pressure. Hypotension may limit
active participation in physical rehabilitation programs and facilitate the deterioration effects of
immobilization and development of undesirable secondary medical complications.
Based on the promising interim outcomes from these feasibility studies, ONWARD is preparing
to initiate further clinical trials to include U.S. participants in 2023.
About Spinal Cord Injury
Spinal cord injury (SCI) represents a major unmet medical need for which there is no cure.
Approximately 7 million people globally have a spinal cord injury, with over 650,000 in the U.S.
and Europe alone. The quality of life of people with SCI can be poor, with paralysis and loss of
sensation, issues with blood pressure control and trunk stability, increased potential for infection,
incontinence, and loss of sexual function. Assistance is required for daily living activities. And SCI
is costly, with the average lifetime cost for paraplegia (paralysis of the legs) of $2.5 million and $5
million for tetraplegia (paralysis of all four limbs). Treatments are urgently needed to restore
movement and improve quality of life.
About ONWARD Medical
ONWARD is a medical technology company creating innovative therapies to restore movement,
independence, and health in people with spinal cord injuries. ONWARD’s work builds on more
than a decade of basic science and preclinical research conducted at the world’s leading
neuroscience laboratories. ONWARD’s ARC Therapy, which can be delivered by implantable
(ARC-IM) or external (ARC-EX) systems, is designed to deliver targeted, programmed spinal cord
stimulation to restore movement and other functions in people with spinal cord injury, ultimately
improving their quality of life.
ONWARD has received five Breakthrough Device Designations from the U.S. FDA encompassing
both ARC-IMand ARC-EX. ARC-EX is an external, non-invasive platform consisting of a wearable
stimulator and wireless programmer. Positive top-line data were reported in September 2022 from
the company’s first pivotal study, called Up-LIFT, evaluating the ability of transcutaneous ARC
Therapy to improve upper extremity strength and function. The company is now preparing
marketing approval submissions for the U.S. and Europe. ARC-IM consists of an implantable
pulse generator and lead that is placed near the spinal cord. The company completed its first-inhuman use of the ARC-IM neurostimulator in May 2022.
ONWARD is headquartered in Eindhoven, the Netherlands. It maintains a Science and
Engineering Center in Lausanne, Switzerland, and has a growing U.S. presence in Boston,
Massachusetts. The company has an academic partnership with .NeuroRestore, a collaboration
between the Swiss Federal Institute of Technology (EPFL) and Lausanne University Hospital
(CHUV). For additional information about the company, please visit ONWD.com.
2 2020 NSCISC Annual Statistical Report Complete Public Version; company data
3
For Company Enquiries:
For Media Enquiries:
MC Services AG
US: Laurie Doyle, P: +1 339 832 0752
Europe: Dr. Johanna Kobler, Katja Arnold, Kaja Skorka P: +49 89 210 228 0
For Investor Enquiries:
Disclaimer
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the
Company or, as appropriate, the Company directors’ current expectations and projections about future
events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions
that could cause actual results or events to differ materially from those expressed or implied by the forwardlooking statements. These risks, uncertainties and assumptions could adversely affect the outcome and
financial effects of the plans and events described herein. A multitude of factors including, but not limited
to, changes in demand, competition, and technology, can cause actual events, performance, or results to
differ significantly from any anticipated development. The interim outcomes presented in this press release
need to be confirmed in a large-scale clinical study, the results of which could differ from the outcomes
described herein. Forward-looking statements contained in this press release regarding past trends or
activities should not be taken as a representation that such trends or activities will continue in the future.
As a result, the Company expressly disclaims any obligation or undertaking to release any update or
revisions to any forward-looking statements in this press release as a result of any change in expectations
or any change in events, conditions, assumptions, or circumstances on which these forward-looking
statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary
undertakings or any such person’s officers or employees guarantees that the assumptions underlying such
forward-looking statements are free from errors nor does either accept any responsibility for the future
accuracy of the forward-looking statements contained in this press release or the actual occurrence of the
forecasted developments. You should not place undue reliance on forward-looking statements,
which speak only as of the date of this press release
Disclaimer
Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.