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Mainz Biomed Appoints Steve Quinn as VP Business Development

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Mainz Biomed Appoints Steve Quinn as VP Business Development




Mainz Biomed Appoints Steve Quinn as VP Business Development

Highly experienced diagnostics business development executive appointed to lead growth initiatives across international markets and drive international sales of ColoAlert at-home screening test for Colorectal Cancer

BERKELEY, Calif. and MAINZ, Germany, Jan. 27, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the appointment of Steve Quinn as Vice President of Business Development.

“We’re very excited to welcome Steve to the team. He comes to us with strong commercial experience in the field of both molecular genetics and diagnostics,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The impressive global network he has built during his notable business development career will be highly valuable as we look to expand the markets for our ColoAlert diagnostic test across Europe and into the Middle East and Asia and later across the United States pending FDA approval.”

Steve is a former medical technologist having spent several years working for the UK’s NHS. His in-depth commercial experience spans both medical devices and molecular genetics and he has held a number of senior executive positions with international healthcare organizations including, OneOme, Progenity and Abbott Diagnostics.

In these previous roles, he has successfully led the introduction of new technologies to international markets and developed international business through distributor partnerships including private and public laboratories, pharmacy chains, private hospitals, public hospitals, and country-specific distribution partners. In his role as VP Business Development, Steve will provide overall leadership and strategic direction for all new Company business development initiatives across international markets.

“In the relatively short term, Mainz Biomed’s ColoAlert test has an opportunity to become the global gold standard, at-home screening test for Colorectal Cancer. I’m extremely excited to join a driven team at a key stage in the company’s growth and play a part in helping the Company realize its significant potential.”

About ColoAlert
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemistry test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVD marked (complying with EU safety, health and environmental requirements) and is transitioning to compliance with IVDR. The product is commercially available in a selection of countries in the European Union. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.
*Dollinger MM et al. (2018)

About Colorectal Cancer
Colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC which cost patients an average of $38,469 per year. The American Cancer Society estimates that in 2021 there will be approximately 149,500 new cases of colon and rectal cancer in the U.S. with 52,980 resulting in death. Recent FDA decisions suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years. Appropriately testing these US-based 50+ populations every three years as prescribed equates to a US market opportunity of approximately $3.7 Billion per year.

About Mainz Biomed N.V.
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert, an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer. ColoAlert is currently marketed across Europe with FDA clinical study and submission process intended to be launched in the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio includes PancAlert, an early-stage pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples, and the GenoStick technology, a platform being developed to detect pathogens on a molecular genetic basis.

For more information, please visit www.mainzbiomed.com

For media enquiries, please contact press@mainzbiomed.com

For investor enquiries, please contact ir@mainzbiomed.com

Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its Prospectus filed on October 12, 2021 and amended on October 25, 2021 and November 1, 2021. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Positive Early Access to Medicines Scheme (EAMS) Scientific Opinion Awarded to GBT’s Voxelotor for the Treatment of Haemolytic Anaemia Due to Sickle Cell Disease

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Positive Early Access to Medicines Scheme (EAMS) Scientific Opinion Awarded to GBT’s Voxelotor for the Treatment of Haemolytic Anaemia Due to Sickle Cell Disease




Positive Early Access to Medicines Scheme (EAMS) Scientific Opinion Awarded to GBT’s Voxelotor for the Treatment of Haemolytic Anaemia Due to Sickle Cell Disease

LONDON, Jan. 27, 2022 (GLOBE NEWSWIRE) — Global Blood Therapeutics (GBT) today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has awarded a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for voxelotor, an oral once-daily tablet under review by the MHRA for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide. This positive opinion means that those patients living with SCD and meeting the eligibility criteria can gain early, pre-license access to voxelotor, while the MHRA completes its review of the Marketing Authorisation Application (MAA).

The aim of EAMS is to grant early access to medicines that have received Promising Innovative Medicine (PIM) designation for patients in the UK with life-threatening or seriously debilitating conditions prior to marketing authorisation when there is a clear unmet medical need. Medicines under EAMS that receive marketing authorisation by the MHRA as well as a positive assessment by the National Institute of Health and Care Excellence (NICE) also benefit from accelerated NHS England commissioning.

Following a positive opinion from the Committee for Medicine Products for Human Use (CHMP) recommending the approval of voxelotor in the European Union (EU), GBT submitted an application to the MHRA for a Great Britain Marketing Authorisation using the European Commission (EC) Decision Reliance Procedure. If approved, voxelotor would be the first medicine in Great Britain and Europe that directly inhibits sickle haemoglobin polymerisation, the molecular cause of sickling and destruction of red blood cells in SCD.

SCD is a rare genetic condition that affects approximately 15,000 people in the UK.1 People living with SCD and those closest to them experience a lifelong journey with the disease that touches every aspect of their lives. Patients experience progressive, serious complications and morbidities, including end-organ damage, which lead to decreased quality of life and early mortality.2 Furthermore, economic disadvantages and health inequalities experienced by many patients with SCD can have negative societal impacts in areas such as access to healthcare, education and employment.3–9

“This decision marks a significant milestone for the sickle cell community in the UK,” said Arvind Agrawal, UK Medical Director at GBT. “The EAMS positive scientific opinion is a key step forward to meeting our goal of providing patients in the UK with the first oral treatment option that inhibits red blood cell sickling and has the potential to reduce acute and chronic complications of sickle cell disease. GBT is delighted with the progress to help eligible patients have access to this innovation as soon as possible.”

Voxelotor is currently approved in the United States, under the brand name Oxbryta®, for the treatment of SCD in adults and children 4 years of age and older.10 The Ministry of Health and Prevention (MOHAP) in the United Arab Emirates (UAE) has granted marketing authorisation for voxelotor as an oral treatment for SCD in adults and children 12 years of age and older.

For more information on the GBT Early Access to Medicines Scheme please contact EAMSinquiry@gbt.com.

About Sickle Cell Disease
Sickle cell disease (SCD) affects approximately 15,000 people in the UK,1 an estimated 52,000 people in Europe,11 and millions of people throughout the world, particularly among those whose ancestors are from sub-Saharan Africa.12 It also affects people of Hispanic, South Asian, Southern European and Middle Eastern ancestry.12 SCD is a lifelong inherited rare blood disorder that impacts haemoglobin, a protein carried by red blood cells that delivers oxygen to tissues and organs throughout the body.13 Due to a genetic mutation, individuals with SCD form abnormal haemoglobin known as sickle haemoglobin. Through a process called haemoglobin polymerisation, red blood cells become sickled, crescent-shaped and rigid.2,13–14 The recurrent sickling process causes destruction of the red blood cells and haemolytic anaemia (low haemoglobin due to red blood cell destruction) and blockages in capillaries and small blood vessels, which impede the flow of blood and oxygen delivery throughout the body. The diminished oxygen delivery to tissues and organs can lead to life-threatening complications, including stroke and irreversible organ damage.2,14–16 Complications of SCD begin in early childhood and can include neurocognitive impairment, acute chest syndrome, and overt stroke, among other serious issues.17

About Voxelotor Tablets
Voxelotor is an oral, once-daily therapy that works by increasing haemoglobin’s affinity for oxygen. Since oxygenated sickle haemoglobin does not polymerise, voxelotor inhibits sickle haemoglobin polymerisation and the resultant sickling and destruction of red blood cells leading to haemolysis and haemolytic anaemia, which are pathologies faced by every single person living with sickle cell disease (SCD). Through addressing haemolytic anaemia and improving oxygen delivery throughout the body, GBT believes that voxelotor has the potential to modify the course of SCD. In November 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Oxbryta (voxelotor) tablets for the treatment of SCD in adults and children 12 years of age and older, and in December 2021, the U.S. FDA expanded the approved use of Oxbryta for the treatment of SCD in patients 4 years of age and older.10

In recognition of the critical need for new SCD treatments, voxelotor has been granted Priority Medicines (PRIME) designation from the European Medicines Agency (EMA). Voxelotor was designated by the European Commission (EC) as an orphan medicinal product for the treatment of patients with SCD. In addition, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK granted voxelotor a Promising Innovative Medicine (PIM) designation.

About Global Blood Therapeutics
Global Blood Therapeutics, Inc. (GBT) is a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder. The company has introduced Oxbryta (voxelotor) tablets and tablets for oral suspension, the first FDA-approved medicine that directly inhibits sickle haemoglobin (HbS) polymerisation, the root cause of red blood cell sickling in SCD. GBT is also advancing its pipeline programme in SCD with inclacumab, a P-selectin inhibitor in Phase 3 development to address pain crises associated with the disease, and GBT021601 (GBT601), the company’s next generation HbS polymerisation inhibitor. In addition, GBT’s drug discovery teams are working on new targets to develop the next generation of treatments for SCD. To learn more, please visit www.gbt.com.

References

  1. Sickle Cell Society. About Sickle Cell. https://www.sicklecellsociety.org/about-sickle-cell/. Accessed January, 2022.
  2. Kato GJ, et al. Sickle cell disease. Nat Rev Dis Primers. 2018;4:18010
  3. McClish DK, et al. Health related quality of life in sickle cell patients: the PiSCES project. Health Qual Life Outcomes. 2005;3:50.
  4. Daniel LC, et al. Lessons Learned From a Randomized Controlled Trial of a Family-Based Intervention to Promote School Functioning for School-Age Children With Sickle Cell Disease. J Pediatr Psychol. 2015;40:1085-1094.
  5. Dampier C, et al. Health-related quality of life in adults with sickle cell disease (SCD): a report from the Comprehensive Sickle Cell Centers Clinical Trial Consortium. Am J Hematol. 2011;86:203-205.
  6. Dampier C, et al. Health-related quality of life in children with sickle cell disease: a report from the Comprehensive Sickle Cell Centers Clinical Trial Consortium. Pediatr Blood Cancer. 2010;55:485-494.
  7. Anie KA, et al. Sickle cell disease: Pain, coping and quality of life in a study of adults in the UK. Br J Health Psychol. 2002;7:331-344.
  8. Kambasu DM, et al. Health-related quality of life of adolescents with sickle cell disease in sub-Saharan Africa: a cross-sectional study. BMC Hematol. 2019;19:9.
  9. Lubeck D, et al. Estimated Life Expectancy and Income of Patients With Sickle Cell Disease Compared With Those Without Sickle Cell Disease. JAMA Netw Open. 2019;2:e1915374.
  10. Oxbryta (voxelotor) tablets prescribing information. South San Francisco, Calif. Global Blood Therapeutics, Inc.; December 2021.
  11. European Medicines Agency. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3182125. Accessed January, 2022.
  12. Centers for Disease Control and Prevention website. Sickle Cell Disease (SCD). https://www.cdc.gov/ncbddd/sicklecell/data.html. Accessed January, 2022.
  13. National Heart, Lung, and Blood Institute website. Sickle Cell Disease. https://www.nhlbi.nih.gov/health-topics/sickle-cell-disease. Accessed January, 2022.
  14. Rees DC, et al. Sickle cell disease. Lancet. 2010;376(9757):2018-2031.
  15. Kato GJ et al. Intravascular hemolysis and the pathophysiology of sickle cell disease. J Clin Invest. 2017;127:750-760.
  16. Caboot JB, et al. Hypoxemia in sickle cell disease: significance and management Paediatr Respir Rev. 2014;15(1):17-23.
  17. Cooper TE et al. Pharmacological interventions for painful sickle cell vaso-occlusive crises in adults. Cochrane Database of Systematic Reviews. 2019.

Contacts:
Claudia Nabaie (media Europe)
+41 79 906 5814
cnabaie@gbt.com

Versius introduced in leading public hospitals in Egypt

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Versius introduced in leading public hospitals in Egypt




Versius introduced in leading public hospitals in Egypt

Versius introduced in leading public hospitals in Egypt

  • Renowned teaching hospital, Ain Shams University Specialized Hospital, was the first hospital to introduce Versius
  • Demand for Versius continues to grow across MEA with rapidly expanding caseloads across a range of surgical specialties

Cambridge, United Kingdom. 27 January 2022 00:01 (GMT). CMR Surgical – the global surgical robotics business – has today announced the launch of its Versius® Surgical Robotic System in Egypt. Versius has been introduced at both Ain Shams University Specialized Hospital and the International Hospital for Urology & Nephrology (IHUN), as CMR works with ATG group to meet significant demand for Versius from one of the largest countries in the Middle East and Africa (MEA) region. Versius is being used to perform a range of high-volume general surgery and urological procedures, helping to treat patients with colorectal and urological cancers, bowel and kidney disease.

High tech surgical care is highly prominent in the health system in Egypt, with adoption of the latest technology for RAS growing rapidly in Ministry of Health supported public hospitals in Egypt, such as Ain Shams. Ain Shams is one of the largest teaching hospitals in Africa and the Middle East and has a strong reputation globally as a research centre and training institute. The hospital was the first in Egypt to adopt Versius, where it is being used for a range of general and urological surgical procedures. At IHUN, Versius has been used in urological surgery. Using robotic keyhole surgery in these cases may reduce recovery time for a patient when compared to open surgery and can significantly reduce physical strain of operating for the surgeon.

Mark Slack, Chief Medical Officer of CMR Surgical said: “There is huge potential for surgical robotics in Egypt, a healthcare system that is renowned for clinical and academic excellence. The adoption of Versius by Ain Shams, one of the largest public teaching hospitals, and IHUN, a dedicated urological centre, is just the beginning. The diversity of procedures being completed across both Ain Shams and IHUN is a testament to the versatility of Versius. It is encouraging to see that in the short time that they have been using Versius, they have been able to complete a high-volume of procedures primarily treating a range of cancers, cementing the value Versius can offer healthcare systems globally.”

Dr Tarek Youssef, Senior General & Colorectal Surgeon at Ain Shams University Hospital said: “Due to its size and modular design, we have easily been able to incorporate Versius into our busy clinical practice, performing complex surgeries that would otherwise have had to be performed using open surgery. Versius provides advantages in terms of increased accuracy and dexterity, both crucial assets in oncologic surgery, whilst also providing significant benefits to patients. We are delighted to be an innovator in Egypt as the first to use Versius and look forward to providing more patients with robotic surgery in the future.”

The news of Versius launching in Egypt follows the recent successful introductions of the system in Pakistan and in the United Arab Emirates (UAE), where CMR have recently opened a hub to support the UAE region. Versius is now being used across the Middle East, Europe, India and Australia to perform surgical procedures across a range of specialities including gynaecology, colorectal surgery, thoracic surgery general surgery and urology.

— ENDS —

Media Contacts:

If you wish to see more, please contact CMR Surgical at:

Press Office, CMR Surgical
T +44(0) 1223 755801
E pressoffice@cmrsurgical.com

Notes to editors:

The Versius® Surgical Robotic System

Versius® resets expectations of robotic surgery. Versius fits into virtually any operating room set-up and integrates seamlessly into existing workflows, increasing the likelihood of robotic minimal access surgery (MAS). The small, portable and modular design of Versius allows the surgeon to only use the number of arms needed for a given procedure.

Biomimicking the human arm, Versius gives surgeons the choice of optimised port placement alongside the dexterity and accuracy of small fully-wristed instruments. With 3D HD vision, easy-to adopt instrument control and a choice of ergonomic working positions, the open surgeon console has the potential to reduce stress and fatigue and allows for clear communication with the surgical team. By thinking laparoscopically and operating robotically with Versius, patients, surgeons and healthcare professionals can all benefit from the value that robotic MAS brings.

But it’s more than just a robot. Versius captures meaningful data with its wider digital ecosystem to support a surgeon’s continuous learning. Through the Versius Connect app, Versius Trainer and CMR clinical registry, Versius unleashes a wealth of insights to ultimately improve surgical care.

About CMR Surgical Limited

CMR Surgical (CMR) is a global medical devices company dedicated to transforming surgery with Versius®, a next-generation surgical robot.

Headquartered in Cambridge, United Kingdom, CMR is committed to working with surgeons, surgical teams and hospital partners, to provide an optimal tool to make robotic minimal access surgery universally accessible and affordable. With Versius, we are on a mission to redefine the surgical robotics market with practical, innovative technology and data that can improve surgical care.

Founded in 2014, CMR Surgical is private limited company backed by an international shareholder base.

OKYO Pharma Limited- PDMR Dealing

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OKYO Pharma Limited- PDMR Dealing




OKYO Pharma Limited- PDMR Dealing

LONDON and BOSTON, Jan. 27, 2022 (GLOBE NEWSWIRE) — OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF), a biotechnology company focused on the discovery and development of novel molecules to treat inflammatory dry eye diseases and ocular pain, today announces that it has been notified that Panetta Partners Limited, an entity in which Gabriele Cerrone, the Executive Chairman has a beneficial interest, purchased 200,000 ordinary shares of no par value in the market at prices between 5p and 5.5p per share.

The acquisitions increase Mr Cerrone’s beneficial interests in the capital of the Company from 52.64% to 52.66%.

1. Details of PDMR / person closely associated
a) Name Gabriele Cerrone
2. Reason for the notification
a) Position / status Chairman
b) Initial notification /amendment Initial notification
3. Details of the issuer
a) Name OKYO Pharma Limited
b) LEI 213800VVN5CB56Y15A05
4. Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type  of transaction; (iii) each date; and (iv) each place where transactions have  been conducted
a) Description of the financial instrument Ordinary Shares of no par value
b) Identification code of the Financial Instrument ISIN for OKYO Pharma Limited: GG00BD3FV870
c) Nature of the transaction Market Purchase
d) Price(s) and volume(s) 5p – 100,000

5.5p – 100,000
f) Date of the transaction 26 January 2022
g) Place of the transaction XLON

Enquiries:

OKYO Pharma Limited Gary S. Jacob, Chief Executive Officer

Gabriele Cerrone, Non-Executive Chairman

 +44 (0)20 7495 2379
     
Optiva Securities Limited
(Broker)		 Robert Emmet +44 (0)20 3981 4173

Notes for Editors:

About OKYO

OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF) is a life sciences and biotechnology company admitted to listing on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain.

About OK-101

OK-101 is a lipidated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor which is typically found on immunological cells of the eye responsible for the inflammatory response. OK-101 was developed using a membrane-anchored-peptide (MAP) Technology to produce a novel long-acting drug candidate for treating DED. OK-101 has been shown to produce anti-inflammatory activity in mouse models of DED and is designed to combat washout through the inclusion of the lipid ‘anchor’ contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment.

About Dry Eye Disease (DED)

Dry eye is a multifactorial disease that results in ocular discomfort and tear film instability that can lead to ocular surface damage. It is often a chronic problem, particularly in older adults, and is expected to become even more prevalent with the aging population and increased use of digital screens such as computers and smart phones. Despite new product approvals, dry eye disease (DED) remains a significant unmet medical need and is one of the leading causes for patient visits to eye care specialists. Novel therapies that improve the signs and symptoms of dry eye disease will be beneficial to dry eye patients.

For further information, please visit the Company’s website at www.okyopharma.com.

Nicox to Participate in Financial, Pharmaceutical Industry and Scientific Events in H1 2022

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Nicox to Participate in Financial, Pharmaceutical Industry and Scientific Events in H1 2022




Nicox to Participate in Financial, Pharmaceutical Industry and Scientific Events in H1 2022

Press Release
Nicox to Participate in Financial, Pharmaceutical Industry and Scientific Events in H1 2022

January 27, 2022
Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that members of the management team will participate in the following financial, pharmaceutical industry and scientific conferences in Europe and U.S. in the coming months:

Financial and pharmaceutical Industry conferences

  • BIOMED Event – March 8, 2022 – Paris, France
  • SmallCap Event – April 4-5, 2022, Paris, France
  • Invest Access Event – April 4-5, 2022 – Paris, France
  • BIO International Convention – June 13-16, 2022 – San Diego, U.S.
  • Spring Midcap Event – June 23-24, 2022 – Paris, France

Members of the management team will be available for one-on-one meetings at these events.

Scientific conferences

About Nicox
Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. .
Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes.

For more information on Nicox, its products or pipeline, please visit: www.nicox.com.
Analyst coverage
Bryan, Garnier & Co         Dylan Van Haaften        Paris, France
Edison Investment Research        Pooya Hemami        London, UK
H.C. Wainwright & Co        Yi Chen        New York, U.S.
Kepler Cheuvreux        Damien Choplain        Paris, France		  
The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.

Contacts
Nicox
Gavin Spencer
Executive Vice President, Chief Business Officer
& Head of Corporate Development
T +33 (0)4 97 24 53 00
communications@nicox.com
Investors & Media
United States & Europe
LifeSci Advisors, LLC
Sandya von der Weid
T +41 78 680 05 38
svonderweid@lifesciadvisors.com		  
Forward-Looking Statements
The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.

Risks factors which are likely to have a material effect on Nicox’s business are presented in the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2020’ filed with the French Autorité des Marchés Financiers (AMF) on March 1, 2021 and in the 2nd chapter of the amendment to the “Document d’Enregistrement Universel, rapport financier annuel et rapport de gestion 2020” filed with the AMF on December 9, 2021 which are available on Nicox’s website (www.nicox.com).
Nicox S.A.
Drakkar 2
Bât D, 2405 route des Dolines
CS 10313, Sophia Antipolis
06560 Valbonne, France
T +33 (0)4 97 24 53 00
F +33 (0)4 97 24 53 99

 

Attachment

Epizyme Announces Pricing of Public Offering of Common Stock

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Epizyme Announces Pricing of Public Offering of Common Stock




Epizyme Announces Pricing of Public Offering of Common Stock

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today announced the pricing of an underwritten public offering of 56,666,667 shares of its common stock at a price to the public of $1.50 per share, before underwriting discounts. In addition, Epizyme has granted the underwriters a 30-day option to purchase up to an additional 8,500,000 shares of common stock at the public offering price, less the underwriting discount. All of the shares in the offering are to be sold by Epizyme.

Epizyme anticipates the total gross proceeds from the offering (before deducting underwriting discounts and offering expenses) will be approximately $85.0 million, excluding any exercise of the underwriters’ options to purchase additional shares.

Epizyme anticipates using the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to fund global development and commercialization costs of tazemetostat outside of Japan, including the costs of conducting the Company’s ongoing and planned clinical trials of tazemetostat, including the Company’s confirmatory Phase 1b/3 trials in epithelioid sarcoma and follicular lymphoma (FL), the Company’s clinical trials of tazemetostat in additional FL populations and the Company’s clinical trials of tazemetostat across multiple types of hematological malignancies and solid tumors; to fund the Company’s Phase 1/1b trial of its SETD2 inhibitor, EZM0414 and the discovery and identification of additional product candidates to expand the Company’s pipeline of novel epigenetic therapies; to fund initiatives to accelerate commercial adoption of TAZVERIK®; and for working capital and other general corporate purposes, which may include the acquisition of companies or businesses or licensing of other products, businesses or technologies, and repayment and refinancing of debt.

Jefferies and Barclays are acting as joint bookrunning managers for the offering. Wedbush PacGrow and H.C. Wainwright & Co. are acting as co-lead managers. The offering is expected to close on January 31, 2022, subject to the satisfaction of customary closing conditions.

The shares are being offered by Epizyme pursuant to a shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (“SEC”) on May 6, 2021 and declared effective by the SEC on May 13, 2021. The offering is being made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. The preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on January 26, 2022 and copies of the preliminary prospectus supplement relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at barclaysprospectus@broadridge.com or by telephone at (888) 603-5847. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Epizyme, Inc.

Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer through novel epigenetic medicines. The Company is focused on creating medicines that are targeted at specific causes of diseases, that are orally administered, tolerable, easy to take and based on a deep understanding of the patients that may benefit from them. The Company aspires to change the standard-of-care for patients and physicians by developing medicines with fundamentally new mechanisms of action.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc., including statements about the Company’s public offering, anticipated use of proceeds, future operations, commercial sales of TAZVERIK, clinical development of the Company’s therapeutic candidates, expectations regarding future clinical trials and future expectations and plans and prospects for the Company and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all; uncertainties associated with the commercialization of pharmaceutical products; uncertainties inherent in the initiation of future clinical studies and in the availability and timing of data from ongoing clinical studies; whether results from preclinical studies or earlier clinical studies of the Company’s product candidates will be predictive of the results of future trials; whether the Company will receive regulatory approvals, including accelerated approval, to conduct trials or to market products; whether the Company’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other factors discussed in the “Risk Factors” section of the preliminary prospectus supplement filed with the SEC, the Company’s most recent Form 10-K and Form 10-Q filed with the SEC and the risks described in other filings that the Company may make with the SEC. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

Contacts

Media:
Erin Graves

media@epizyme.com
(617) 500-0615

Investors:
Caitlin Stern

Real Chemistry

cstern@realchemistry.com

Relief Reports that its U.S. Collaboration Partner has Announced Receipt of Initial Report of Patient Safety and Survival from Right to Try Use of Aviptadil During Omicron Surge

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RELIEF THERAPEUTICS Holding AG / Key word(s): Research Update

27-Jan-2022 / 07:15 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

The issuer is solely responsible for the content of this announcement.

Relief Reports that its U.S. Collaboration Partner has Announced Receipt of Initial Report of Patient Safety and Survival from Right to Try Use of Aviptadil During Omicron Surge

Geneva, Switzerland, January 27, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief“), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx“), of its collaboration partner with respect to aviptadil, NeuroRx, Inc. (“NeuroRx“), has announced receipt of a first safety report from a Southwestern hospital where physicians have administered aviptadil to patients with COVID-19 respiratory failure. According to the press release, the patients were treated under the Federal Right to Try Law that gives access to investigational medicines for patients who have been diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options, and who are unable to participate in a clinical trial to access certain unapproved treatments. The press release stated that of the first 19 patients treated by December 31, 2021, three had died and 16 (84%) were reported to be alive by January 22, 2022. The release also reported that this Right to Try use of aviptadil occurred during the current Omicron surge, although patients were not necessarily tested for the specific COVID variant that caused their ICU admission. NRx reported that no serious adverse events were reported. The related NRx press release can be accessed through the following link.

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com		 FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx’s recently submitted application to the FDA seeking EUA for aviptadil to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including Remdesivir and who are ineligible for enrollment into the ACTIV-3b NIH-sponsored trial will be approved, (ii) whether RELIEF THERAPEUTICS Holding SA will be successful in its lawsuit against NRx’s subsidiary, NeuroRx, and NeuroRx’s CEO, Jonathan Javitt, and in defending NeuroRx’s recently filed lawsuit against Relief, (iii) whether the upcoming mediation between the parties to the disputes between Relief and NeuroRx will be successful, (iv) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 or any other disease, and (v) those risks discussed in RELIEF THERAPEUTICS Holding SA’s press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Additional features:

File: Relief Reports that its U.S. Collaboration Partner has Announced Receipt of Initial Report of Patient Safety and Survival from Right to Try Use of Aviptadil During Omicron Surge

End of ad hoc announcement
Language: English
Company: RELIEF THERAPEUTICS Holding AG
Avenue de Sécheron 15
1202 Genève
Switzerland
E-mail: contact@relieftherapeutics.com
Internet: https://relieftherapeutics.com
ISIN: CH0100191136
Listed: SIX Swiss Exchange
EQS News ID: 1273331

 
End of Announcement EQS News Service

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Acer Therapeutics and Relief Therapeutics Announce Presentation of Four ACER-001 Posters at the Upcoming SIMD and GMDI Conferences

Posted on by

RELIEF THERAPEUTICS Holding AG / Key word(s): Conference

27-Jan-2022 / 07:00 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

The issuer is solely responsible for the content of this announcement.

Acer Therapeutics and Relief Therapeutics Announce Presentation of Four ACER-001 Posters at the Upcoming SIMD and GMDI Conferences

Data to be presented suggests ACER-001 could represent a potential alternative to sodium and glycerol phenylbutyrate for treatment of UCDs

NEWTON, MA and GENEVA, SWITZERLAND – Jan. 27, 2022 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced the acceptance of four ACER-001 abstracts for poster presentations at the upcoming Society for Inherited Metabolic Disorders (SIMD) Annual Meeting on April 10-13, 2022 in Orlando, Florida, and the Genetic Metabolic Dieticians International (GMDI) Conference on May 4-7, 2022, in Las Vegas, Nevada. The ACER-001 New Drug Application (NDA) for urea cycle disorders (UCDs) is currently under U.S. Food and Drug Administration (FDA) review with a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022.

“Many UCDs patients currently taking nitrogen scavengers may struggle with elevated ammonia levels potentially associated with consequences of treatment non-compliance,” said Chris Schelling, Chief Executive Officer and Founder of Acer. “The data from our bioequivalence and taste assessment studies accepted for presentations at the SIMD and GMDI conferences further support our belief that, if approved, ACER-001 could offer an alternative to current therapies that may lead to meaningful clinical outcomes in UCDs patients.”

Raghuram (Ram) Selvaraju, Chairman of Relief, added, “The acceptance of ACER-001 data at these prestigious industry conferences is another important milestone for this potential treatment for patients with UCDs. We are highly encouraged by the continued progress of the ACER-001 program and look forward to the FDA’s decision on the PDUFA target action date in June.”

Details of the presentations are as follows:

2022 SIMD 43rd Annual Meeting
Title: The Pharmacokinetics of Taste-Masked Sodium Phenylbutyrate (Acer-001) for the Treatment of Urea Cycle Disorders Under Fasting and Fed Conditions in Healthy Volunteers
Presenter: Dr. Robert Steiner
Poster #: 84
Date/Time: April 11, 2022; 7:00-8:00 pm ET

Title: Taste-Masked Coating of Sodium Phenylbutyrate (Acer-001) Improves the Palatability of Sodium Phenylbutyrate for Treatment of Urea Cycle Disorders
Presenter: Dr. Stephen Cederbaum
Poster #: 18
Date: April 11, 2022; 7:00-8:00 pm ET

Additionally, Acer is sponsoring a lunchtime symposium at SIMD on April 12th at 12:45 pm ET. The symposium, entitled: “Addressing Unmet Needs in Screening, Diagnosis, Therapeutics and Advocacy for Urea Cycle Disorders (UCDs),” will be hosted by Robert D Steiner, MD, FAAP, FACMG; Professor (Clinical) University of Wisconsin; Editor in Chief of Genetics in Medicine; Wisconsin Newborn Screening Program Medical Consultant; and Chief Medical Officer of PreventionGenetics.

2022 GMDI Conference
Title: ACER-001: a Potential Alternative to Sodium and Glycerol Phenylbutyrate for Treatment of Urea Cycle Disorders
Presenter: Dr. Robert Steiner
Poster #: 26
Date: May 5, 2022; 5:30-7:00 pm PT

Title: Taste-masked Coating of Sodium Phenylbutyrate (ACER-001) Improves the Palatability of Sodium Phenylbutyrate for Treatment of Urea Cycle Disorders
Presenter: Dr. Stephen Cederbaum
Poster #: 10
Date/Time: May 5, 2022; 5:30-7:00 pm PT

Additionally, Acer is sponsoring a breakfast symposium at GMDI on May 5th at 7:00 am PT. The symposium, entitled: “Energy and Protein Needs in UCD Patients: What We Know and What We Need to Know to Move Towards Personalized Care,” will be hosted by Deborah Geary Hook, MPH, RDN, FAND, PhDc. PhD Candidate, University of California, Davis.

Parties interested in the ACER-001 program for UCDs may sign up for updates at:
https://www.acertx.com/rare-disease-research/acer-001-for-urea-cycle-disorders-ucds/

About UCDs
UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2 The current treatment of patients with UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI(R) and BUPHENYL(R), in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports3, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include aversive taste and odor4, frequency with which medication must be taken, required number of pills, and the high cost of the medication.

About ACER-001
ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). ACER-001’s multi-particulate dosage formulation for oral administration is designed to minimize the aversive taste and odor4 of sodium phenylbutyrate while quickly dissolving in the stomach. The ACER-001 NDA for UCDs is currently under FDA review with a PDUFA target action date of June 5, 2022. ACER-001 is also being developed for MSUD and has been granted orphan drug designation by the FDA for this indication. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.

About Acer Therapeutics Inc.
Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO(TM) (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief for development and commercialization of ACER-001. For more information, visit www.acertx.com.

About RELIEF THERAPEUTICS Holding SA
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

References

1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.

2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).

3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

4. Peña-Quintana L, et al. Profile of sodium phenylbutyrate granules for the treatment of urea-cycle disorders: patient perspectives. Patient Prefer Adherence. 2017 Sep 6;11:1489-1496.

Acer Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and 10-Q/A, and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Relief Forward-Looking Statements
This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer’s NDA for ACER-001, (ii) whether RELIEF THERAPEUTICS Holding SA will be able to submit an application for approval of ACER-001 in Europe in Q2/Q3 2022 (or at all), (iii) whether any such application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patient in Europe with UCDs will be approved, (iv) whether RLF-100 (aviptadil) will receive emergency use authorization in the United States, (v) whether RLF-100 (aviptadil) will ever be submitted for authorization in Europe, (vi) whether RELIEF THERAPEUTICS Holding SA’s ongoing disputes with its U.S. collaboration partner for RLF-100 (aviptadil) can be resolved amicably, and (vii) those other risks, uncertainties and factors described in RELIEF THERAPEUTICS Holding SA’s press releases, periodic filings with the SIX Stock Exchange, all of which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

CORPORATE CONTACTS
Acer Therapeutics:
Jim DeNike
Acer Therapeutics Inc.
jdenike@acertx.com
+1 844-902-6100

RELIEF THERAPEUTICS Holding SA:
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com

INVESTOR RELATIONS CONTACTS
Acer Therapeutics:
Hans Vitzthum
LifeSci Advisors
hans@lifesciadvisors.com
+1 617-430-7578

RELIEF THERAPEUTICS Holding SA:
Michael Miller
Rx Communications Group
mmiller@rxir.com
+1-917-633-6086

Additional features:

File: Acer Therapeutics and Relief Therapeutics Announce Presentation of Four ACER-001 Posters at the Upcoming SIMD and GMDI Conferences

End of ad hoc announcement
Language: English
Company: RELIEF THERAPEUTICS Holding AG
Avenue de Sécheron 15
1202 Genève
Switzerland
E-mail: contact@relieftherapeutics.com
Internet: https://relieftherapeutics.com
ISIN: CH0100191136
Listed: SIX Swiss Exchange
EQS News ID: 1273337

 
End of Announcement EQS News Service

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Sierra Oncology Announces Pricing of Upsized Public Offering of Securities

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Sierra Oncology Announces Pricing of Upsized Public Offering of Securities




Sierra Oncology Announces Pricing of Upsized Public Offering of Securities

SAN MATEO, Calif.–(BUSINESS WIRE)–Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, today announced the pricing of an upsized underwritten public offering of 4,074,075 shares of its common stock and, in lieu of shares of common stock, to a certain investor, pre-funded warrants to purchase up to 925,925 shares of common stock pursuant to its existing shelf registration statement. The shares of common stock are being offered at a public offering price of $27.00 per share and the pre-funded warrants are being offered at a public offering price of $26.999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. The expected gross proceeds to Sierra Oncology from the offering is approximately $135.0 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Sierra Oncology has granted to the underwriters a 30-day option to purchase up to 750,000 of additional shares of its common stock at the public offering price less underwriting discounts and commissions. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes. All of the securities are being offered by Sierra Oncology. The offering is expected to close on or about January 31, 2022, subject to customary closing conditions.

Jefferies and Cantor are acting as the joint book-running managers and representatives of the underwriters for the offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the securities offered in the public offering described above was filed with the SEC on November 5, 2021 and declared effective by the SEC on November 12, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, New York 10022, or by email at prospectus@cantor.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Sierra Oncology

Sierra Oncology is a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer. We harness our deep scientific expertise to identify compounds that target the root cause of disease to advance targeted therapies with assets on the leading edge of cancer biology. Our team takes an evidence-based approach to understand the limitations of current treatments and explore new ways to change the cancer treatment paradigm. Together we are transforming promise into patient impact.

Contacts

Investors
DeDe Sheel

415.732.9828

dsheel@sierraoncology.com

Media Contact
Lauren Musto

615.351.7777

lmusto@sierraoncology.com

 

Yokogawa Survey Reveals Significant Impact of Industrial Autonomy on Environmental Sustainability

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Yokogawa Survey Reveals Significant Impact of Industrial Autonomy on Environmental Sustainability




Yokogawa Survey Reveals Significant Impact of Industrial Autonomy on Environmental Sustainability

TOKYO–(BUSINESS WIRE)–#IA2IA–Yokogawa Electric Corporation (TOKYO: 6841) reveals today the results of its latest survey* to gain further insights into the current and future state of industrial autonomy in process manufacturing. The survey highlights that the number of manufacturers moving forward with industrial autonomy is clearly increasing, and that there is a high awareness of the expected benefits on environmental sustainability.


The global survey was conducted in seven markets (China, Germany, India, Japan, Saudi Arabia, SE Asia and the US) amongst 534 respondents from 390 companies in the chemical & petrochemical, life sciences, oil & gas, power generation, and renewable energy industry sectors.

Key insights

Regarding environmental sustainability, 45% of the respondents anticipate that industrial autonomy will have a significant impact and another 36% expect a moderate impact in the areas of dynamic energy optimization, water management, and emissions reduction. In contrast, only 6% expect industrial autonomy to have no impact at all on environmental sustainability.

The implementation of industrial autonomy projects is starting to gather pace, with 51% of the respondents surveyed now scaling deployment across multiple facilities and business functions and another 19% reporting they have deployed in at least one facility or business function.

While productivity improvements in production and manufacturing processes are expected to deliver the highest return on investment (ROI) in digital transformation over the next three years – with 31% ranking this area first and a further 20% ranking it second – health, safety and environment is emerging as a key area of ROI, with 26% ranking it first (13%) or second (13%).

With the ongoing COVID-19 pandemic, increasing remote operations capabilities represents a key factor in industrial autonomy. The survey reveals that one-third (33%) of manufacturers have deployed remote operations in single sites and 31% have implemented across multi-sites in connection to industrial autonomy.

C-level executives play a key role in plant-level autonomous planning, with the survey respondents saying that the Chief Executive Officer (38%), Chief Technical Officer (34%), and Chief Information Officer (31%) are the primary final decision-makers. These decision-makers are supported by senior level technical professionals, with 43% saying the Chief Digital Officer has significant influence on plant level autonomy decisions.

“It is gratifying to see from our latest survey that environmental sustainability is emerging as an area in which the shift from industrial automation to industrial autonomy, which we call IA2IA, is expected to make a significant positive impact,” explained Tsuyoshi Abe, senior vice president and head of the Marketing Headquarters at Yokogawa Electric. “Overall, however, our survey also indicates that one of the biggest challenges in implementing industrial autonomy is the lack of a clear roadmap, with almost half seeing it as their most significant challenge. This underlines the importance of a defined roadmap to industrial autonomy and finding the right partner to develop it.”

The survey report can be downloaded from the following website:

https://www.yokogawa.com/ia2ia/

* The “Global End-user Survey on the Implementation of Industrial Autonomy” was conducted on behalf of Yokogawa by research company Omdia in September 2021 among 534 respondents from 390 companies across seven global markets: China, Germany, India, Japan, Saudi Arabia, SE Asia, and the US. Respondents comprised manufacturers/end-users, OEMs, and systems integrators in the chemical & petrochemical, life sciences, upstream and mid-stream oil & gas, refining, power generation, and renewable energy power generation industry sectors. The survey respondents were in IT management, operations/project/plant management, and corporate management.

About Yokogawa

Yokogawa provides advanced solutions in the areas of measurement, control, and information to customers across a broad range of industries, including energy, chemicals, materials, pharmaceuticals, and food. Yokogawa addresses customer issues regarding the optimization of production, assets, and the supply chain with the effective application of digital technologies, enabling the transition to autonomous operations.

Founded in Tokyo in 1915, Yokogawa continues to work toward a sustainable society through its 17,500 employees in a global network of 119 companies spanning 61 countries.

For more information, visit www.yokogawa.com
The names of corporations, organizations, products, services and logos herein are either registered trademarks or trademarks of Yokogawa Electric Corporation or their respective holders.

Contacts

Media inquiries:
PR Section,

Integrated Communications Center

Yokogawa Electric Corporation

E-mail: Yokogawa-pr@cs.jp.yokogawa.com