FDA approves Roche’s Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) in adults and children 2 months and older

  • In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA
  • Evrysdi helped infants survive without permanent ventilation and achieve the ability to sit without support, a key motor milestone not normally seen in the natural course of the disease
  • Evrysdi is the first and only medicine for SMA that can be taken at home

             
Basel, 10 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Evrysdi™ (risdiplam) for the treatment of spinal muscular atrophy (SMA) in adults and children 2 months of age and older. Evrysdi showed clinically-meaningful improvements in motor function across two clinical trials in people with varying ages and levels of disease severity, including Types 1, 2, and 3 SMA. Infants achieved the ability to sit without support for at least 5 seconds, a key motor milestone not normally seen in the natural course of the disease. Evrysdi also improved survival without permanent ventilation at 12 and 23 months, compared to natural history. A liquid medicine, Evrysdi is administered daily at home by mouth or feeding tube.

“Given the majority of people with SMA in the U.S. remain untreated, we believe Evrysdi, with its favorable clinical profile and oral administration, may offer meaningful benefits for many living with this rare neurological disease,” said Levi Garraway, M.D., Ph. D., Roche’s Chief Medical Officer and Head of Global Product Development. “The strength and resolve of the SMA community has continually inspired us as we developed this first-of-its-kind medicine for SMA, so today we celebrate our collective accomplishment together with them.”

Evrysdi is being studied in more than 450 people as part of a large and robust clinical trial program in SMA. The program includes infants aged 2 months to adults aged 60 with varying symptoms and motor function, such as people with scoliosis or joint contractures, and those previously treated for SMA with another medication. The approval is based on data from two clinical studies designed to represent a broad spectrum of people living with SMA: FIREFISH in symptomatic infants aged 2 to 7 months; and SUNFISH in children and adults aged 2 to 25 years. SUNFISH is the first and only placebo-controlled trial to include adults with Types 2 and 3 SMA.

In FIREFISH, 41% (7/17) of infants treated with the therapeutic dose achieved the ability to sit without support for at least 5 seconds as measured by the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III). Additionally, 90% (19/21) of infants were alive without permanent ventilation at 12 months of treatment and reached 15 months of age or older. As described in the natural history of untreated infantile-onset SMA, infants would not be expected to be able to sit independently, and only 25 percent would be expected to survive without permanent ventilation beyond 14 months of age. In SUNFISH, children and adults treated with Evrysdi experienced a clinically-meaningful and statistically significant improvement in motor function at 12 months (1.55 point mean difference; p=0.0156) compared to placebo (1.36 points [95% CI: 0.61, 2.11]; -0.19 points [95% CI: -1.22, 0.84], respectively), as measured by a change from baseline in the Motor Function Measure-32 (MFM-32) total score.

Evrysdi demonstrated a favorable efficacy and safety profile, with the safety profile established across the FIREFISH and SUNFISH trials. The most common adverse reactions were fever, diarrhea, and rash in later-onset SMA. In infantile-onset SMA, the most common adverse events were similar and also included upper respiratory tract infection, pneumonia, constipation, and vomiting. There were no treatment-related safety findings leading to withdrawal from either study.

“Throughout their lives, many people with SMA may lose their ability to perform critical movements, which can impact the ability to independently participate in aspects of daily life and even be life altering,” said Kenneth Hobby, president of Cure SMA. “The approval of Evrysdi is an eagerly awaited milestone for our community. We appreciate Genentech/Roche’s commitment to reflecting the full scope of the real-world SMA population in their clinical trial program and developing a treatment that can be administered at home.”

Evrysdi is designed to treat SMA by increasing production of the survival of motor neuron (SMN) protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.

Evrysdi will be available in the United States within two weeks for direct delivery to patients’ homes through Accredo Health Group Inc., an Express Scripts specialty pharmacy.

About Evrysdi™ (risdiplam)
Evrysdi is a survival of motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.

Risdiplam was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. At this time, risdiplam has been filed in Brazil, Chile, China, Indonesia, Russia, South Korea, and Taiwan. A Marketing Authorization Application (MAA) submission to the EMA for Evrysdi is imminent.

About the Pivotal Studies
FIREFISH (NCT02913482)
FIREFISH, an open-label, two-part pivotal study, was designed to assess Evrysdi safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) in patients aged 1 to 7 months with Type 1 SMA. Part 1 evaluated several doses of Evrysdi and determined the therapeutic dose of 0.2 mg/kg for Part 2. In Part 1, after 12 months of Evrysdi treatment:

  • 41% (7/17) of infants treated with the therapeutic dose achieved the ability to sit without support for at least 5 seconds as measured by the BSID-III gross motor scale.
  • 90% (19/21) of all infants were alive without permanent ventilation* and reached 15 months of age or older
  • 81% (17/21) of all patients were alive without permanent ventilation* after a minimum of 23 months of treatment and reached an age of 28 months or older (median 32 months; range 28 to 45 months)

 * Permanent ventilation defined as tracheostomy or ≥16 hours of noninvasive ventilation per day or intubation for ≥21 consecutive days in the absence of, or following the resolution of, an acute reversible event.

SUNFISH (NCT02908685)
SUNFISH, a two-part placebo-controlled multicenter pivotal trial, was designed to assess Evrysdi safety, tolerability, efficacy, PK and PD in people with Type 2 or 3 SMA aged 2 to 25, including those with scoliosis (67% in Part 2) and joint contractures at baseline. In Part 2, after 12 months, Evrysdi treatment led to:

  • A clinically-meaningful and statistically significant improvement in motor function among children and adults, as measured by a change from baseline in the MFM-32 total score (1.55 point mean difference; p=0.0156), at 12 months as compared to placebo (1.36 points [95% CI: 0.61, 2.11]; -0.19 points [95% CI: 1.22, 0.84], respectively). MFM-32 assesses 32 different motor functions across a wide range of people with SMA.
  • Improved upper limb motor function compared to baseline, as measured by the Revised Upper Limb Module (RULM), a secondary independent motor function endpoint of the study (1.59 point difference; p=0.0028).

Pivotal Trial Safety Data
The safety profile of Evrysdi was established across the FIREFISH and SUNFISH pivotal trials. The most common adverse reactions in later-onset SMA (incidence of at least 10% of patients treated with Evrysdi and more frequently than control) were fever, diarrhea, and rash. The most common adverse reactions in infantile-onset SMA were similar to those observed in later-onset SMA patients. Additionally, the most common adverse reactions (incidence of at least 10%) were upper respiratory tract infection, pneumonia, constipation, and vomiting.

About the Evrysdi Clinical Trial Program

In addition to FIREFISH and SUNFISH, Evrysdi is being evaluated in a broad range of people with SMA, including in:

  • JEWELFISH (NCT03032172): an open-label exploratory trial designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in people with SMA aged 6 months to 60 years who received other investigational or approved SMA therapies for at least 90 days prior to receiving Evrysdi. Recruitment for this study is complete with 174 people enrolled.
  • RAINBOWFISH (NCT03779334): an open-label, single-arm, multicenter study investigating the efficacy, safety, pharmacokinetics and pharmacodynamics of Evrysdi in infants (~n=25), from birth to six weeks of age (at first dose) with genetically diagnosed SMA who are not yet presenting with symptoms. The study is currently recruiting.


About SMA

SMA is a severe, progressive neuromuscular disease that can be fatal. It affects approximately one in 10,000 babies and is the leading genetic cause of infant mortality. SMA is caused by a mutation of the survival motor neuron 1 (SMN1) gene, which leads to a deficiency of SMN protein. This protein is found throughout the body and is essential to the function of nerves that control muscles and movement. Without it, nerve cells cannot function correctly, leading to muscle weakness over time. Depending on the type of SMA, an individual’s physical strength and their ability to walk, eat or breathe can be significantly diminished or lost.

About Roche in Neuroscience
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism spectrum disorder. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Dr. Nicolas Dunant
Phone: +41 61 687 05 17

Patrick Barth
Phone: +41 61 688 44 86
Daniel Grotzky
Phone: +41 61 688 31 10

Karsten Kleine
Phone: +41 61 682 28 31
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Phone: +41 79 327 54 74

Nathalie Meetz
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Phone: +41 61 687 89 67

 

Roche Investor Relations  
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Dr. Sabine Borngräber
Phone: +41 61 68-88027
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Dr. Bruno Eschli
Phone: +41 61 68-75284
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Dr. Birgit Masjost
Phone: +41 61 68-84814
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Investor Relations North America  
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Phone: +1 650 467 8737
e-mail: tuomi.lisa@gene.com

 

Attachment

Addex Therapeutics to Release Half-Year 2020 Financial Results and Host Conference Call on August 12, 2020

Geneva, Switzerland, August 10, 2020 – Addex Therapeutics Ltd (SIX and Nasdaq: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development, will discuss its half-year 2020 financial results, provide a business update and review its pipeline during a teleconference and webcast for investors, analysts and the media on Wednesday, August 12 at 16:00 CEST (14:00 GMT/10:00 ET).

Title:                    Addex Half-Year 2020 Financial Results Conference Call
Date:                   August 12, 2020
Time:                  16:00 CEST (14:00 GMT/10:00 ET)

Joining the Conference Call:

In the 10 minutes prior to the call start time, call the appropriate participant dial-in number.

Dial-in numbers:

Switzerland:         +41 44 58 06 522
United States:      +1 877 4230830
United Kingdom:  +44 203 0092470

Link for other countries

Participation Pin Code: 22285484#

Connect to live event: Link

Password: Welcome

About Addex Therapeutics:
Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to conventional “orthosteric” small molecule or biological drugs. Addex’s allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. Addex’s lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is scheduled to enter a pivotal registration clinical trial for Parkinson’s disease levodopa induced dyskinesia (PD-LID). In parallel, dipraglurant’s therapeutic use in dystonia is being investigated in preclinical models. Addex’s second clinical program ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is scheduled to enter a Phase 2a proof of concept clinical study for the treatment of epilepsy. In addition, Addex’s GABAB PAM program has been licensed to Indivior PLC for the treatment of addiction. Preclinical programs include GABAB PAM for CMT1A, mGlu7 NAM for PTSD, mGlu2 NAM for mild neurocognitive disorders, mGlu4 PAM for Parkinson’s disease and mGlu3 PAM for neurodegenerative disorders. 

Press Contacts:

Tim Dyer
Chief Executive Officer
Telephone: +41 22 884 15 55
Email: PR@addextherapeutics.com
Mike Sinclair
Partner, Halsin Partners
+44 (0)20 7318 2955
msinclair@halsin.com

Forward Looking Statements:
Certain statements made in this announcement are forward-looking statements including with respect to the creation of a trading market for ADSs representing the Company’s shares in the United States. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions securityholders and prospective securityholders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

 

Roche provides update on phase III studies of etrolizumab in people with moderately to severely active ulcerative colitis

  • Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies
  • Etrolizumab failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitis
  • Analyses of these data are ongoing to better understand the results
  • Pivotal phase III study of etrolizumab in Crohn’s disease is ongoing
  • Roche is studying additional investigational medicines in inflammatory bowel diseases

Basel, 10 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced topline results from its phase III study programme evaluating the investigational medicine etrolizumab in people with moderately to severely active ulcerative colitis. Mixed results were seen in studies evaluating etrolizumab as an induction therapy, and both studies evaluating etrolizumab as a maintenance therapy failed to meet their primary endpoints, showing no significant difference in the proportion of people achieving remission with subcutaneous etrolizumab versus placebo.

In the HIBISCUS I induction study, in people without prior anti-tumour necrosis factor (anti-TNF) treatment, etrolizumab met the primary endpoint. In contrast, the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, did not meet its primary endpoint. In the HICKORY study, in people with prior anti-TNF treatment, etrolizumab met the primary endpoint at induction but not at maintenance. In the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab failed to meet its primary endpoint. The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified in the four phase III clinical trials reported to date.

“We are disappointed with these results, because we know that people with ulcerative colitis need new treatment options,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are fully analysing these data to learn more about how we might address the needs of people with this devastating disease. These studies were part of the largest clinical trial programme ever undertaken in inflammatory bowel diseases, and we thank all the patients, investigators and healthcare professionals for their participation.”

Further analyses of the data, including secondary endpoints, are ongoing and will be submitted for presentation at upcoming medical meetings.

Etrolizumab continues to be studied as an investigational induction and maintenance treatment in people with moderately to severely active Crohn’s disease with and without prior anti-TNF treatment in a global phase III study (BERGAMOT) and open-label extension and safety monitoring study (JUNIPER), involving more than 1,100 people with Crohn’s disease. In addition, Roche is studying other investigational medicines in inflammatory bowel diseases and is committed to further understanding this disease.

About inflammatory bowel diseases and ulcerative colitis
Inflammatory bowel diseases (IBD) are a group of chronic gastrointestinal disorders affecting almost 7 million people worldwide.1 The two main types of IBD are ulcerative colitis (mainly affecting the colon and rectum) and Crohn’s disease (affecting the entire gastrointestinal tract).2,3 Patients can experience unpredictable symptoms that include abdominal pain and cramping, frequent and urgent bowel movements, diarrhoea, leakage, rectal bleeding, weight loss, energy loss and fatigue.2,3 About 80% of all individuals with IBD do not experience lasting remission, which can have a long-term impact on quality of life and leave many feeling like they have little control over their daily lives.4

Ulcerative colitis is most commonly diagnosed in young people aged 15 to 30 years, affecting them over the course of their entire future lives.5 Up to a quarter of people with ulcerative colitis will require a colectomy within 10 years of diagnosis, in which all or part of the colon is removed.6

About etrolizumab
Etrolizumab is the first investigational dual anti-integrin studied in inflammatory bowel diseases (IBD). It is designed to target IBD on two fronts by selectively inhibiting α4β7 and αEβ7 to control both trafficking of immune cells into the gut and their inflammatory effects on the gut lining.7

About the etrolizumab study programme
Etrolizumab is being studied in the largest clinical trial programme in inflammatory bowel diseases to date, comprised of eight randomised-controlled and open-label trials.8-15 The landmark study programme includes more than 3,100 patients across six phase III studies, plus two open-label extension (OLE) and safety monitoring studies for ulcerative colitis and Crohn’s disease, spanning more than 40 countries globally, including head-to-head trials against the most common current treatments.

The etrolizumab study programme consists of:

  • Phase III HIBISCUS I and II: Two identical, randomised, double-blind, double-dummy, placebo-controlled, multicentre studies evaluating the efficacy (induction of remission) and safety of etrolizumab versus adalimumab and placebo in patients with moderately to severely active ulcerative colitis who have not been previously treated with anti-tumour necrosis factor (anti-TNF) agents8,9
  • Phase III LAUREL: Randomised, double-blind, placebo-controlled, multicentre study evaluating the efficacy (maintenance of remission) and safety of etrolizumab in patients with moderately to severely active ulcerative colitis who have not been previously treated with anti-TNF agents10
  • Phase III GARDENIA: Randomised, multicentre double-blind, double-dummy study evaluating the efficacy (sustained remission) and safety of etrolizumab versus infliximab in patients with moderately to severely active ulcerative colitis who have not been previously treated with anti-TNF agents11
  • Phase III HICKORY: Double-blind, placebo-controlled, multicentre study evaluating the efficacy and safety of etrolizumab during induction and maintenance in patients with moderately to severely active ulcerative colitis who have been previously treated with anti-TNF agents12
  • COTTONWOOD study: An open-label extension and safety monitoring study of patients with moderately to severely ulcerative colitis previously enrolled in etrolizumab phase II/III studies13
  • Phase III BERGAMOT: A phase III, randomised, double-blind, placebo-controlled, multicentre study evaluating the efficacy and safety of etrolizumab as an induction and maintenance treatment in patients with moderately to severely active Crohn’s disease14
  • JUNIPER study: An open-label extension and safety monitoring study of patients with moderately to severely active Crohn’s disease previously enrolled in the etrolizumab phase III BERGAMOT study15

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020; 5(1):17-30.
[2] Ungaro R, et al. Ulcerative colitis. Lancet. 2017; 389(10080):1756-70.
[3] Torres J, et al. Crohn’s disease. Lancet. 2017; 389:1741-55.
[4] Sandborn WJ. The Present and Future of Inflammatory Bowel Disease Treatment. Gastroenterol Hepatol. 2016; 12:438–41.
[5] Johnston RD and Logan RFA. What is the peak age for onset of IBD? Inflamm Bowel Dis. 2008; 14(supp 2):S4–S5.
[6] Langholz E, et al. Course of ulcerative colitis: analysis of changes in disease activity over years. Gastroenterology 1994; 107(1):3-11.
[7] Stefanich EG, et al. A humanized monoclonal antibody targeting the beta7 integrin selectively blocks intestinal homing of T lymphocytes. Br J Pharmacol. 2011; 162(8):1855-70.
[8] ClinicalTrials.gov. HIBISCUS I [Internet; cited 2020 August 06]. Available from: https://clinicaltrials.gov/ct2/show/NCT02163759.
[9] ClinicalTrials.gov. HIBISCUS II [Internet; cited 2020 August 06]. Available from: https://clinicaltrials.gov/ct2/show/NCT02171429.
[10] ClinicalTrials.gov. LAUREL [Internet; cited 2020 August 06]. Available from: https://clinicaltrials.gov/ct2/show/NCT02165215.
[11] ClinicalTrials.gov. GARDENIA [Internet; cited 2020 August 06]. Available from: https://clinicaltrials.gov/ct2/show/NCT02136069.
[12] ClinicalTrials.gov. HICKORY [Internet; cited 2020 August 06]. Available from: https://clinicaltrials.gov/ct2/show/NCT02100696.
[13] ClinicalTrials.gov. COTTONWOOD [Internet; cited 2020 August 06]. Available from: https://clinicaltrials.gov/ct2/show/NCT02118584?term=02118584&draw=2&rank=1.
[14] ClinicalTrials.gov. BERGAMOT [Internet; cited 2020 August 06]. Available from: https://clinicaltrials.gov/ct2/show/NCT02394028.
[15] ClinicalTrials.gov. JUNIPER [Internet; cited 2020 August 06]. Available from: https://clinicaltrials.gov/ct2/show/NCT02403323.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Dr. Nicolas Dunant
Phone: +41 61 687 05 17

Patrick Barth
Phone: +41 61 688 44 86
Daniel Grotzky
Phone: +41 61 688 31 10

Karsten Kleine
Phone: +41 61 682 28 31
Nina Mählitz
Phone: +41 79 327 54 74

Nathalie Meetz
Phone: +41 61 687 43 05
Barbara von Schnurbein
Phone: +41 61 687 89 67

 

Roche Investor Relations  
Dr. Karl Mahler
Phone: +41 61 68-78503
e-mail: karl.mahler@roche.com

Jon Kaspar Bayard
Phone: +41 61 68-83894
e-mail: jon_kaspar.bayard@roche.com
Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com

Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Dr. Gerard Tobin
Phone: +41 61 68-72942
e-mail: gerard.tobin@roche.com
   
Investor Relations North America  
Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com
Dr. Lisa Tuomi
Phone: +1 650 467 8737
e-mail: tuomi.lisa@gene.com

Attachment

Disclosure of received notification

Regulated information
Nazareth (Belgium)/Rotterdam (The Netherlands), 10 August 2020

Disclosure of received notification

Pursuant to the Belgian law of 2 May 2007 regarding the disclosure of major shareholdings in listed companies, Fagron received a notification of Norges Bank.

Notification of Norges Bank

  • On 4 August 2020, Fagron received a notification of Norges Bank that the total position (voting rights and equivalent financial instruments) had fallen below the disclosure threshold of 3% (the lowest threshold) on 31 July 2020 as the result of the disposal of voting securities or voting rights. 
31 July 2020    
Voting rights 2,055,360 2.85%
Equivalent financial instruments (right to recall) 84,141 0.12%
Total number of voting rights 2,139,501 2.96%
  • The notification of Norges Bank can be viewed on investors.fagron.com via this link

In the event of differences between the English translation and the Dutch original of this press release, the latter prevails.

For more information
Constantijn van Rietschoten
Chief Communications Officer
Tel. +31 6 53 69 15 85
constantijn.van.rietschoten@fagron.com

Please open the link below for the press release:
Disclosure of received notification

Saniona successfully raises USD 65 million (approximately SEK 567 million) in a directed issue of shares

PRESS RELEASE

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURE IN ACCORDANCE WITH APPLICABLE LAW.

August 10, 2020                                                        

Saniona (OMX: SANION) (“Saniona” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced that its Board of Directors has resolved on a directed issue of 30,660,374 shares to a number of U.S. and international institutional investors and sector specialists based on the authorization granted by the Annual General Meeting held on 6 May 2020 (the “Directed Issue”).

  • The new shares were issued at a subscription price of USD 2.12 per share (SEK18.50), and represents a discount of approximately 45 per cent compared to the volume weighted average price (VWAP) on Nasdaq Stockholm for the period of the last 45 days up to and including 7 August 2020.
  • Through the Directed Issue, the Company will receive gross proceeds of USD 65 million (approximately SEK 567 million).
  • The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital and New Leaf Venture Partners among other U.S. and international healthcare investors as well as the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4).
  • The net proceeds will be used to continue Saniona’s advancement of its late-stage clinical trials with Tesomet in two rare eating disorders, hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as to build its U.S.-based organization in support of these programs.

Comment from Rami Levin, President & CEO of Saniona

 “The participation of multiple well-respected U.S. and International institutional healthcare investors in this financing led by RA Capital Management demonstrates the significant potential of Saniona’s rare disease pipeline. With this financing, we will be able to further increase shareholder value by advancing Tesomet to registration for approval, moving our early-stage pipeline into the clinic, and building our U.S. organization. We believe achieving these milestones will position us as potentially the first treatment for two rare diseases, hypothalamic obesity and Prader-Willi Syndrome said Rami Levin, President and CEO of Saniona.

The Directed Issue

The Board of Directors of Saniona has, in accordance with the issue authorization granted by the Annual General Meeting on May 6, 2020, resolved on a directed issue of 30,660,374 shares at a subscription price of USD 2.12  per share (SEK 18.50), consequently raising gross proceeds of USD 65 million (approximately SEK 567 million) before deduction of costs related to the transaction.

The net proceeds will be used to continue Saniona’s advancement of its late-stage clinical trials with Tesomet in two rare eating disorders, hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as to build its U.S.-based organization in support of these programs.

The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital and New Leaf Venture Partners among other U.S. and international healthcare investors as well the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4). The subscription price per share of USD 2.12 (SEK 18.50) has been established through arms’ length negotiations with a number of institutional investors over a period of time. The Company’s Board of Directors is therefore of the opinion that the subscription price has been set at market terms and accurately reflects current market conditions and demand. The reasons for the deviation from the shareholders’ preferential right were mainly to diversify the shareholder base with financially strong and well reputable U.S. and Swedish institutional investors and sector specialists and to enable a capital raise in a time and cost-efficient manner. It is the assessment of the Board of Directors that the Directed Issue is beneficial to the Company and hence for all existing shareholders.

Through the Directed Issue, the number of shares in the Company will increase by 30,660,374 to 61,043,690, and the share capital will increase by SEK 1,533,018.70 to SEK 3,052,184.50. The Directed Issue entails a dilution of approximately 50 per cent for existing shareholders, based on the number of shares in the Company after the Directed Issue.

In connection with the Directed Issue, the Company has agreed pursuant to a lock-up undertaking, subject to customary exceptions, not to issue additional shares or other securities for a period of 90 days following settlement of the Directed Issue. In addition, in connection with the Directed Issue, members of the Board of Directors and management of Saniona have agreed not to sell any shares or other securities in the Company for a period of 90 days following the settlement of the Directed Issue, subject to customary exceptions and furthermore subject to that warrants of series TO2 (where the exercise period runs between 7 September 2020 – 21 September 2020) or shares subscribed through exercise of such warrants are not covered by the lock-up undertaking.

A prospectus relating to the listing of the shares in the Directed Issue on Nasdaq Stockholm is expected to be approved and registered by the Swedish Financial Supervisory Authority (“SFSA”) on or about 13 August, 2020, i.e. before the new shares are subject to trading on Nasdaq Stockholm.

The completion of the Directed Issue is subject to certain customary conditions of the investment agreement entered into by the Company with the investors in connection with the Directed Issue, whereby the investors may for customary reasons terminate the placing in full if it occurs before settlement of the placing.

Financial and legal advisors

Oppenheimer & Co. Inc. and ABG Sundal Collier AB acted as Joint Bookrunners (“Joint Bookrunners”) while Setterwalls Advokatbyrå AB acted as legal advisor to Saniona in relation to Swedish law and Goodwin Procter LLP acted as legal advisor to Saniona in relation to US law.

For more information, please contact

Rami Levin, President & CEO, Saniona, Mobile: +1 781 987 3144, Email: rami.levin@saniona.com

Don DeBethizy, Chairman of the Board, Saniona, Mobile +45 2159 0774, Email: whitecityconsulting@gmail.com

This information is such information as Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 07:00 a.m. CET on August 10, 2020.

About Saniona

Saniona is a rare disease biopharmaceutical company focused on research, development and commercialization of treatments for the central nervous system. The company has four programs in clinical development. Saniona intends to develop and commercialize treatments for rare disease indications such as hypothalamic obesity and Prader-Willi syndrome on its own. The research is focused on ion channels and the company has a broad portfolio of research programs. Saniona also has out-licensing agreements with Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V and Cadent Therapeutics. Saniona is based in Copenhagen, Denmark, and in Boston, US. The company’s shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com.

IMPORTANT INFORMATION

Publication, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in the Company in any jurisdiction, neither from Saniona nor from anyone else.

This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the new shares. Any investment decision in connection with the Directed Share Issue must be made on the basis of all publicly available information relating to the Company and the Company’s shares. The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness.

This announcement does not constitute a recommendation concerning any investor’s option with respect to the Directed Share Issue. Each investor or prospective investor should conduct his, her or its own investigation, analysis and evaluation of the business and data described in this announcement and publicly available information. The price and value of securities can go down as well as up. Past performance is not a guide to future performance.

This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be announced, published, copied or distributed, directly or indirectly, in whole or in part, within or into Australia, Hong Kong, Japan, Canada, New Zeeland, Singapore, South Africa, the United States or in any other jurisdiction where the announcement, publication or distribution of the information would not comply with applicable laws and regulations or would require prospectuses, registration or any other measures than those required by Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations.

This press release is not a prospectus for the purposes of Regulation 2017/1129 of the European parliament and of the council (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. Saniona has not authorized any offer to the public of shares or rights in any member state of the EEA and no offer prospectus has been or will be prepared in connection with the Directed Share Issue. In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Regulation.

This press release is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “Relevant Persons”). This press release must not be acted on or relied on by persons who are not Relevant Persons. Any investment or investment activity to which this press release relates is available only to Relevant Persons and will be engaged in only with Relevant Persons. Persons distributing this press release must satisfy themselves that it is lawful to do so.

This press release may contain forward-looking statements which reflect Saniona’s current view on future events and financial and operational development. Words such as “intend”, “expect”, “anticipate”, “may”, “believe”, “plan”, “estimate” and other expressions which imply indications or predictions of future development or trends, and which are not based on historical facts, are intended to identify forward-looking statements. Forward-looking statements inherently involve both known and unknown risks and uncertainties as they depend on future events and circumstances. Forward-looking statements do not guarantee future results or development and the actual outcome could differ materially from the forward-looking statements.
INFORMATION TO DISTRIBUTORS

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the shares in Saniona have been subject to a product approval process, which has determined that such shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, Distributors should note that: the price of the shares in Saniona may decline and investors could lose all or part of their investment; the shares in Saniona offer no guaranteed income and no capital protection; and an investment in the shares in Saniona is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Directed Share Issue.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the shares in Saniona.

Each distributor is responsible for undertaking its own target market assessment in respect of the shares in Saniona and determining appropriate distribution channels.

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AnHeart Announces Entry into Series A+ Equity Financing Agreements

Proceeds to be Used for Advancing Taletrectinib Phase 2 Trials and Expanding Oncology Portfolio

HANGZHOU, China and NEW YORK, Aug. 09, 2020 (GLOBE NEWSWIRE) — AnHeart Therapeutics, Co., Ltd. (“AnHeart”), a clinical stage oncology company focused on underserved patients in global markets, has entered into agreements to raise over 20 million USD in an over-subscribed Series A+ equity financing round.

Proceeds from the financing will be used to advance the global Phase 2 trials of taletrectinib, a potent and highly selective next generation ROS1/NTRK inhibitor as well as to further expand AnHeart’s oncology portfolio.

“The financing will permit us to execute on our global development plan for taletrectinib, and help advance this differentiated cancer drug for utilization in a large population of NSCLC patients with ROS1 and NTRK mutations,” said Junyuan (Jerry) Wang, PhD, Chief Executive Officer of AnHeart. “In addition, we desire to expand into other oncology adjacencies where we may have a competitive advantage and to deepen our pipeline over time. We value the support of our experienced and esteemed investors to help us execute on our vision.”

About Taletrectinib:
The lead clinical candidate taletrectinib is a next-generation, potent, highly selective ROS1 and NTRK inhibitor that can cross the blood-brain barrier. AnHeart licensed the global rights to taletrectinib from Daiichi Sankyo Company Limited. Two Phase 1 studies in the U.S. and Japan have been reported with promising safety and efficacy data. Taletrectinib inhibits both ROS1 fusion WT and  crizotinib-resistant secondary mutations, including G2032R. There is no approved drug against resistant mutations like G2032R, which may lead to rapid penetration of taletrectinib in major global markets. The mutation rate of the oncogenic driver ROS1 fusion is about 2 to 3 percent in patients with advanced NSCLC, and the rate of NTRK fusion is about 0.5 percent in patients with various solid tumors. The estimated number of new patients diagnosed with advanced NSCLC each year is about 1.8 million worldwide.

The results of two Phase 1 studies in the US and Japan support the potential of taletrectinib to be a next generation ROS1/NTRK inhibitor with durable responses and activity in brain metastases. Based on a data cutoff date in March 2019 from two Phase 1 trials, the mPFS in TKI-naïve and 1 TKI-pretreated patients were 24.9 months and 18.4 months, respectively, with a generally acceptable safety profile. More information about the Phase 1 and ongoing phase 2 trials may be found at clinicaltrials.gov with NCT02279433, NCT02675491 and NCT04395677.

About AnHeart:
AnHeart Therapeutics Co., Ltd. (AnHeart”) is a clinical stage biopharmaceutical company developing novel oncology therapies. AnHeart is headquartered in Hangzhou, China with offices in Beijing, Shanghai and New York. Formed in November 2018, AnHeart is currently managed by biopharmaceuticals industry veterans and financially backed by venture capital funds.

Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are not limited to, (i) statements regarding the timing of anticipated clinical trials for our product candidates and our research and development programs; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (iv) the size of patient populations targeted by our product candidates and market adoption of our product candidates by physicians and patients; and (v) the timing or likelihood of regulatory filings and approvals. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. This Presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration or regulatory agencies in other countries. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied.

AnHeart Contact:
Akira Jing Liu, MD
Director of Business Development
(86) 137-0181-9470 (c)
ajliu@anhearttherapeutics.com

Investor Relations Contact:
Irina Koffler
Managing Director
LifeSci Advisors, LLC
646-970-4681 (w)
917-734-7387 (c)
ikoffler@lifesciadvisors.com

School Air Filtration Expert Weighs In on – Can We Safely Reopen Schools and Public Buildings This Fall?

The concern is while children have a lower risk of contracting COVID-19, masks and social distancing measures may not be enough to control the spread of the disease.

Riverdale, New Jersey, Aug. 09, 2020 (GLOBE NEWSWIRE) — Although it would usually be the beginnings of the back-to-school season, parents and children across the country are left with uncertainty as to whether or not schools will be opening their doors. The Trump administration is making a push to reopen schools to full capacity in the fall. Some health experts agree as many schools overseas have opened, but others in the health industry do not agree with the reopening.  The concern is while children have a lower risk of contracting COVID-19,  masks and social distancing measures may not be enough to control the spread of the disease should asymptomatic students encounter adults once they are away from school. 

If masks and social distancing aren’t enough to prevent the spread of COVID-19, what measures can we take instead? 

Making Schools, Office Buildings, and Malls Safer with Air Filtration

According to a report by the Inside Edition, one way to make schools safer is to install high-efficiency air filters in the air handling units and by using stand-alone room air purifiers with HEPA filters as a supplement. The COVID-19 virus primarily spreads through infected respiratory droplets and possibly through droplet nuclei and aerosols, which are much smaller and lighter and can therefore, remain airborne for longer periods of time. Without proper air filtration, it’s possible these aerosols can get caught in the return of an HVAC system and recirculate into other parts of the building, thus spreading the infection further. 

“If a building’s ventilation system has the capacity, Camfil air filtration experts recommend an air filter labeled as a MERV-15A or MERV-16A. Unfortunately, some equipment is unable to accommodate the larger size of those filters. In those cases, a  basic guideline would be to install the highest MERV-A that infrastructure can handle,” says Greg Herman, Camfil’s National Accounts Segment Manager.

About Camfil Clean Air Solutions 

For more than half a century, Camfil worldwide has been helping people breathe cleaner air. As a leading manufacturer of premium clean air solutions, we provide commercial and industrial systems for air filtration and air pollution control that improve worker and equipment productivity, minimize energy use, and benefit human health and the environment. During the COVID-19 pandemic, Camfil has been applying their decades of experience in biosafety containment, healthcare, and other sectors of the air filtration industry to provide technological solutions for the public as well as in hospitals and healthcare facilities. 

https://www.camfil.com/en-us

##

Media Contact: 

Lynne Laake 

Camfil USA Air Filters 

T: 888.599.6620 

E: Lynne.Laake@camfil.com

F: Friend  Camfil USA on Facebook

T: Follow Camfil USA on Twitter 

Y: Watch Camfil Videos on YouTube

L: Follow our LinkedIn Page

News for Camfil via Camfil Newsroom on  https://hvacairfiilters.submitmypressrelease.com

Follow Camfil blog for more stories https://cleanair.camfil.us

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OpGen Co-Markets COVID-19 Antibody Test Kit

GAITHERSBURG, Md., Aug. 09, 2020 (GLOBE NEWSWIRE) — As disclosed in OpGen, Inc.’s (NASDAQ: OPGN) (“OpGen” or “the Company”) July 13, 2020 press release, we have commenced marketing and promotion, on a non-exclusive basis, of certain products offered by Menarini Silicon Biosystems (MSB) to infectious disease healthcare providers and researchers.  As part of the co-promotion relationship, OpGen is marketing and promoting the CELLSEARCH system, CELLSEARCH CEC kit, and certain COVID-19 related products that are sold and distributed by MSB on a non-exclusive basis.  OpGen is authorized to market and promote such products in the United States, Canada, and Mexico under a strategic co-promotion agreement entered into by OpGen and MSB.  As described in our tweet on August 7, 2020, the COVID-19 related products include an IgG/IgM Rapid Test Cassette that is manufactured by Healgen and sold by MSB, which is an antibody test that provides results in as fast as 10 minutes.  As further described at http://www.siliconbiosystems.com/covid-19-tests, the IgG/IgM Rapid Test Cassette has been authorized by the FDA under an emergency use authorization for use by authorized laboratories.  The test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.  Under the terms of the co-promotion agreement, OpGen is entitled to certain payments based on MSB’s net sales from customers referred by OpGen for such products, including the IgG/IgM Rapid Test Cassette.  The parties expect to continue to expand the portfolio of COVID-19 products available as part of the non-exclusive co-promotion relationship.

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.

OpGen Forward-Looking Statement

This press release includes statements regarding the Menarini Silicon Biosystems commercial partnership for COVID-19 related tests by OpGen. These statements and other statements regarding the Companies’ future plans and goals constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the realization of expected benefits of our business combination transaction with Curetis GmbH, the success of our commercialization efforts, the impact of COVID-19 on the Company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen’s business, please review the Company’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information, please visit www.opgen.com.

OpGen:
Oliver Schacht
President and CEO
InvestorRelations@opgen.com

OpGen Press Contact:
Matthew Bretzius
FischTank Marketing and PR
matt@fischtankpr.com

OpGen Investor Contact:
Megan Paul
Edison Group
mpaul@edisongroup.com 

Aino Health AB (publ): Aino Health decides on a fully secured rights issue of shares of approximately SEK 15.9 million

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SWITZERLAND, SINGAPORE, SOUTH AFRICA, OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, PUBLICATION OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL, BE SUBJECT TO LEGAL RESTRICTIONS OR WOULD REQUIRE REGISTRATION OR OTHER MEASURES.

The Board of Directors of Aino Health AB (publ) (“Aino Health” or the “Company”) has, subject to approval at the Extraordinary General Meeting on 9 September 2020, decided to carry out a rights issue of a maximum of 10,623,319 shares (the “Rights issue”). The subscription price per share is SEK 1.50, whereby Aino Health upon full subscription in the Rights issue receives approximately SEK 15.9 million before issue costs. For every (1) existing share on the record date on 16 September 2020, two (2) subscription rights are received and three (3) subscription rights entitle the holder to subscribe for one (1) new share. The subscription period is between 18 September – 2 October 2020. The Rights issue is fully secured through underwriting commitments from the existing shareholders Filip Engelbert and Jonas Nordlander. No underwriting compensation is paid for the underwriting commitments. The proceeds from the Rights issue will be used for working capital to execute according to the current growth plan. The Rights issue is conditional on the Extraordinary General Meeting resolving to reduce the Company’s share capital by SEK 15,934,979.00 without the withdrawal of shares and that the limits for the number of shares and share capital in the Articles of Association are changed. This reduces the Company’s share capital to SEK 23,902,468.50 and the share’s quota value to SEK 1.50. Notice to the Extraordinary General Meeting will be issued through a separate press release.

The Rights issue in brief

  • Approximately SEK 15.9 million before transaction costs is expected to be raised in the Rights issue if fully subscribed.
  • The Rights issue is fully secured through underwriting commitments from the existing shareholders Filip Engelbert and Jonas Nordlander. No underwriting compensation is paid for the underwriting commitments.
  • Shareholders will receive two (2) subscription rights (the “Subscription right”) for every (1) share held on the record date. Three (3) Subscription rights entitle the holder to subscribe for one (1) new share.
  • The record date for the Rights issue is planned to be 16 September 2020 with the last day of trading including the Subscription rights on 14 September 2020 and the first day of trading excluding the Subscription rights on 15 September 2020.
  • The subscription price is SEK 1.50 per share. The subscription period for the Rights issue (the “Subscription period”) is expected to commence on 18 September and it is expected to end on 2 October 2020.
  • The proceeds from the Rights issue will be used for working capital to execute according to the current growth plan.

Reasons for the Rights issue and use of proceeds

Aino Health develops and markets IT-based and scalable tools for preventive management of employee absence. The target groups are municipalities, organizations and company managements with a need to increase health awareness in their organizations.

The Company’s products and services are based on Software as a Service, a cloud service that offers software and system support for Health Management. The technology is globally applicable with an increasing aim towards a more sustainable health policy. The Company’s products and services contribute, among other things, to strengthening companies’ competitiveness by offering solutions for managing the employees’ health, well-being and employee engagement, as well as reducing absence related costs.

Aino Health is in an expansion phase and the goal is to confirm the Company’s position in existing markets and to establish and develop operations in the Nordic region and the rest of Europe. However, the ongoing COVID-19 pandemic has affected the Company in a slowdown in sales to new potential customers. As part of reducing its expenses, the Company has, as previously communicated, taken a government-guaranteed loan of approximately SEK 2 million, deferred payments of taxes, VAT, employer contributions and used the opportunity for part-time layoffs via Tillväxtverket. In addition, Aino Health has worked hard over the past quarter to achieve a controlled cash flow. Through a reorganization, the Company has scaled down some of the overhead costs by, among other things, reducing the workforce and the Company will also reduce the monthly salaries of the CEO and CFO by 40 percent between October 2020 and the end of December 2021. The reduced workforce has enabled Aino Health to now have a more fast-paced organization that will focus on continued growth and to provide the market with the best possible SaaS solution in the segment.

In order to secure working capital for the upcoming twelve-month period, to be able to execute according to the proposed growth plan, the Board has decided on the Rights issue, which will give the approximately SEK 15.9 million if fully subscribed.

Terms of the Rights issue

The Board of Directors of the Company has decided to carry out a Rights issue of at most 10,623,319 shares, subject to the approval of the Extraordinary General Meeting on 9 September 2020. The main terms for the Rights issue are presented below.

  • All shareholders will be given two (2) Subscription rights for every (1) share held in the Company on the record date, which is planned to be 16 September 2020. Three (3) Subscription rights will entitle the holder to subscribe for one (1) new share.
  • The Subscription rights are planned to be traded on Nasdaq First North Growth Market between 18 September 2020 and 30 September 2020.
  • After the subscription, temporary shares corresponding to the shares subscribed for based on the Subscription rights (the “Temporary shares”) will be entered into the subscriber’s book-entry account.
  • The shares will be entered into the subscriber’s book-entry account once they have been entered into the Trade Register, approximately during week 43/44, 2020.
  • Trading in the Temporary shares is planned to commence on Nasdaq First North Growth Market on 18 September 2020.
  • The record date for the Rights issue is planned to be 16 September 2020 with the last day of trading including the Subscription rights on 14 September 2020 and the first day of trading excluding the Subscription rights on 15 September 2020.
  • The subscription price is SEK 1.50 per share. The Subscription period for the Rights issue is expected to commence on 18 September and it is expected to end on 2 October 2020.
  • The dilution for current shareholders from the Rights issue, upon full subscription, amounts to 40.0 percent.
  • The Rights issue is conditional on the Extraordinary General Meeting resolving to reduce the Company’s share capital by SEK 15,934,979.00 without the withdrawal of shares and that the limits for the number of shares and share capital in the Articles of Association are changed.

Underwriting commitments

The Rights issue is fully secured through underwriting commitments of SEK 15.9 million from the Company’s owners Filip Engelbert and Jonas Nordlander. No compensation is paid for the underwriting commitments.

Indicative timetable

  • 9 August 2020: Decision regarding the Rights issue by the Board of Directors  
  • 14 September 2020: Last day of trading including the Subscription rights
  • 15 September 2020: First day of trading excluding the Subscription rights  
  • 16 September 2020: Record date for the Rights issue  
  • Week 38 2020: The memorandum is published  
  • 18-30 September 2020: Trading period of Subscription rights  
  • From 18 September 2020 until registration at the Swedish Companies Registration Office: Trading starts in Temporary shares (BTA)  
  • 18 September – 2 October 2020: The Subscription period for the Rights issue  
  • 7 October 2020: Announcement of the outcome of the Rights issue

Advisers

Augment Partners AB is acting project leader and Advokatfirman Lindahl Kommanditbolag is acting legal advisor in connection to the Rights issue.

For further information, please contact:

Jyrki Eklund, CEO Aino Health AB (publ) Tel: +358 40 042 4221

E-mail: jyrki.eklund@ainohealth.com

This information is of the kind that the Company is required to disclose in accordance with the EU’s Market Abuse Regulation. The information was issued for publication through the agency of the contact person set out above on 9 August, 2020 at 19.05 CEST.

About Aino Health (publ)

Aino Health is the leading supplier of Software as a Service solutions in Corporate Health Management. The company’s complete system of SaaS platforms and services reduces sick leave, lowers related costs, and improves business results through increased productivity and employee engagement by making health and wellbeing,  an integrated part of everyday work. For more information: https://investors.ainohealth.com/en.

Aino Health AB (publ) is listed at Nasdaq First North Growth Market (Ticker: AINO). Erik Penser Bank AB, +46 8 463 83 00, certifiedadviser@penser.se is the Certified Adviser to the company.

Important information

Publication or distribution of this press release may in some jurisdictions be subject to statutory and legal restrictions and persons in those jurisdictions where this press release has been published or distributed should inform themselves about and observe such restrictions. The information in this press release does not constitute an offer to acquire, subscribe, or otherwise trade in shares or other securities in Aino Health.

This press release does not constitute an offer to acquire securities in the United States. The securities mentioned herein may not be sold in the United States without registration in accordance with The Securities Act of 1933 or without the application of an exception to such registration. The information in this press release may not be released, published, reproduced or distributed in or to the United States, Australia, Canada, New Zealand, Hong Kong, Japan, Switzerland, Singapore, South Africa, or any other country or jurisdiction where such action is not permitted or such action is subject to legal restrictions or would require further registration or other measures than required by Swedish law. Measures contrary to this instruction may constitute a breach of applicable securities laws

Lung cancer researchers present new clinical trial data at International Association for the Study of Lung Cancer World Conference on Lung Cancer Virtual Presidential Symposium

CheckMate 743 Shows That Dual Immunotherapy, Nivolumab + Ipilimumab, Improves Overall Survival for Patients with Previously Untreated Mesothelioma

DENVER, Aug. 08, 2020 (GLOBE NEWSWIRE) — The combination of first-line nivolumab and ipilimumab demonstrated an improvement of overall survival for patients with unresectable malignant pleural mesothelioma compared to platinum-based chemotherapy.

The study is presented by Paul Baas, M.D., from The Netherlands Cancer Institute and The University of Leiden, in Amsterdam. Watch a video of Dr. Baas explaining his research here: https://vimeo.com/443190432/32a40271f0

Nivolumab is an immunotherapy that works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Ipilimumab is a monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. When administered in combination, this dual immunotherapy has shown clinical benefit in 6 different tumor types, including mesothelioma.

In this large phase III study, Dr. Baas and the global study investigators randomly assigned more than 600 patients: 303 to the nivolumab + ipilimumab arm and 302 to the chemotherapy arm.  The study had a minimal follow up of close to two years. Two-year overall survival rates were 40.8% for the patients in the experimental treatment arm vs 27.0% in chemotherapy arm. Of the 30.3% of patients in the study-combination group who experienced grade 3-4 adverse events, 15% discontinued therapy compared with 7.4% of the 32.0% of patients in chemotherapy group. 

“CheckMate 743 met its primary endpoint of statistically improved OS with nivolumab + ipilimumab vs standard of care chemotherapy in first-line treatment of patients with mesothelioma,” said Dr. Baas. “These clinically meaningful data represent the first positive phase 3 trial of immunotherapy in first-line MPM and should be considered as a new standard of care.”

Phase 3 eXalt3 Study Shows Significantly Longer Progression-Free Survival in Patients with ALK+ Lung Cancer with Ensartinib Versus Crizotinib

Patients with non-small cell lung cancer (NSCLC) carrying anaplastic lymphoma kinase (ALK) gene alterations who received ensartinib experienced substantially longer progression-free survival than a matched group of patients who received crizotinib.

The results were presented today by Leora Horn, MD, Ingram Associate Professor of Cancer Research in the Division of Hematology/Oncology and director of the Thoracic Oncology Program at Vanderbilt-Ingram Cancer Center, Nashville, Tenn. View a video interview of Dr. Horn discussing the trial here: https://vimeo.com/444703327/6ad043dd00.

Ensartinib (X-396) is a novel next-generation ALK tyrosine kinase inhibitor (TKI). According to Dr. Horn, in Phase 1 and 2 studies, ensartinib showed promising activity in patients with ALK+ NSCLC who were ALK TKI treatment naive or received prior crizotinib or second-generation ALK TKIs, including strong activity in patients with brain metastases.

Crizotinib is an anti-cancer drug acting as an ALK, MET, and ROS1 inhibitor, approved for treatment of some subtypes of patients with NSCLC (including ALK+) in the United States and other countries worldwide.

Dr. Horn and her colleagues at the participating cancer centers randomized 290 patients with ALK+ NSCLC to either ensartinib or crizotinib—the prespecified intent to treat (ITT) population with locally determined ALK+ NSCLC.  Patients were stratified by prior chemotherapy, Eastern Cooperative Oncology Group performance status, brain metastases, and geographic region. Baseline characteristics were well balanced between the two groups: median age was 54.1; 26% of patients had prior chemotherapy, and 36% of patients had baseline brain metastases (5% had prior brain radiotherapy). The modified ITT population (the prespecified patient population that was ALK+ as confirmed by central Abbott FISH test) included 247 patients, of which 121 received ensartinib and 126 received crizotinib.

At the July 1, 2020 data cutoff, based on a pre-planned interim analysis design (at 75% of progression-free survival events) treatment was ongoing in 64 ensartinib-treated patients (45%) and 25 crizotinib-treated patients (17%).  There were 139 patients who experienced disease progression (as assessed by blinded independent review committee, BIRC) or death, which represented 73% of progression events in the ITT population and 119 BIRC-events or deaths (63%) in the mITT population.

According to Dr. Horn, the trial’s analysis demonstrated a statistically significant difference between patients who received ensartinib, with a median progression-free survival of 25.8 months compared with 12.7 months with crizotinib, with a median follow-up of 23.8 and 20.2 months, respectively (HR, 0.52; 95% CI, 0.36-0.75; P=.0003 by log-rank test).  In the mITT population, the median progression-free survival has not been reached yet for the ensartinib arm vs. 12.7 months for the crizotinib arm (HR, 0.48; 95% CI, 0.32-0.71; P=.0002 by log-rank test).

The overall response rate was 75% versus 67% with crizotinib; among patients with measurable brain metastases, the BIRC-assessed intracranial overall response rate was 64% with ensartinib versus 21% with crizotinib.

The time-to-treatment-failure rate in the brain in patients with no baseline brain metastases was also significantly lower with ensartinib compared to crizotinib (4% vs 24% at 12 months).

“In patients with ALK-positive NSCLC, ensartinib significantly prolonged progression-free survival over crizotinib with a favorable safety profile, representing a new option in the first-line setting,” Dr. Horn concluded.

Addition of Sintilimab to Pemetrexed and Platinum Improved Progression-Free Survival in Patients with Nonsquamous Non-Small Cell Lung Cancer—Results of ORIENT-11 Presented at IASLC Virtual Presidential Symposium

The interim analysis of ORIENT-11, a phase III double-blind randomized trial has shown a nearly two-fold increase in progression-free survival with addition of sintilimab to chemotherapy in patients with advanced or metastatic non-squamous non-small cell lung cancer without EGFR or ALK genomic aberrations, according to research data presented today at the International Association for the Study of Lung Cancer Virtual Presidential Symposium.

The research findings are also published simultaneously in the Journal of Thoracic Oncology, the journal of the International Association for the Study of Lung Cancer.

Previously, sintilimab in combination with pemetrexed and a platinum-based chemotherapy had shown promising activity for nonsquamous non small cell lung cancer in a phase 1b study, according to Li Zhang, M.D., of Sun Yat-sen University Cancer Center, Guangzhou, China.

Dr. Zhang and investigators from centers in China enrolled 397 patients in the study. Of these, 266 and 131 patients were randomly assigned to the sintilimab combination and to placebo combination, respectively. Patients with all ranges of PD-L1 expression (by tumor proportion score, TPS) were included. The median progression free survival per was significantly improved in sintilimab-combination group compared to placebo combination group (8.9 vs. 5.0 months).

Dr. Zhang reported that sintilimab-combination group showed a nominally significant improvement of overall survival The overall response rate also was improved for the sintilimab-combination group (51.9% versus 29%). The safety signal for the sintilimab combination was similar to that found in other studies, but rates of occurrence of grade > 3 adverse events were slightly higher in the sintilimab-combination group (61.7% versus 58.8%).

“This study demonstrated that the addition of sintilimab to chemotherapy significantly improved progression-free survival and a nominally improved overall survival, with an acceptable safety profile in [patients with] first-line non-squamous non small cell lung cancer,” said Dr. Zhang. “In this study, we collected tumor samples at baseline of treatment. So, our next work will focus on biomarker exploration. By RNA sequencing of tumor samples, we look forward to searching a potential biomarker which can predict the survival benefit from PD-1 combination with chemotherapy.”

For more information, visit https://www.iaslc.org/Conferences-Events/Event-Details/iaslc-wclc-2020-singapore-virtual-presidential-symposium

Chris Martin CMartin@DavidJamesGroup.com | 630-670-2745