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ABIDJAN, Cote d’Ivoire, Nov. 13, 2020 (GLOBE NEWSWIRE) — The global recovery from the COVID-19 pandemic will depend on the world coming together in a collective endeavour backed by science, finance and political resolve, African Development Bank president Akinwumi Adesina, told the Victoria Forum 2020, a virtual event addressing the long-term socio-economic impacts of COVID-19.

“How we come out of this pandemic, and the speed of our collective recovery, will depend on our shared collective global responsibility, to join hands to mobilize scientific and financial resources backed by strong political will,” Adesina said during the opening plenary.

Joining Adesina for a panel discussion themed BridgingDivides in the Wake of a Global Pandemic were Hakima El Haite, President of Liberal International, a global federation of liberal and progressive political parties; and Elizabeth Dowdeswell, Lieutenant Governor of Ontario.

In the face of a global pandemic, it is more essential than everyone in government, business, academia and civic life draws upon their shared values to forge a path forward, said George Furey, Canadian Senator and current Senate speaker said in opening remarks.

The forum aims to deepen understanding of the COVID-19 pandemic’s impact on economic, social and environmental divides within and across countries and communities. It also seeks solutions to help the world “build back better, greener and more inclusively,” said Kevin Hall, President of the University of Victoria, Canada, co-host of the forum.

Dowdeswell noted the gender-specific impacts of the COVID-19 crisis, referring to the economic slowdown as a “shecession”. She stressed the importance of evidence-based decision-making and effective communication by leaders, noting “we make progress at the speed of trust”.

Adesina highlighted a number of disparities that the pandemic has laid bare in Africa, citing the health care divide, a fiscal divide, a gender divide, and a jobs and labour divide. To illustrate his point, he noted that Africa imported 70 %to 80% of pharmaceuticals even before the onset of COVID-19, a situation worsened by the pandemic.

Still, Adesina stressed Africa’s potential and said that fully tapping its natural resources and human capital underpinned the Bank’s strategy. “We need to mobilize the domestic resources that we have—oil gas, minerals, agriculture and biodiversity, and the institutional investors, sovereign wealth funds, pension funds and all the mutual funds that we have, in total about $1.8 trillion dollars.”

Commenting on whether tackling COVID-19 eclipsed the fight against climate change, Dr El Haite said both challenges were intertwined. “Nobody is talking about the fact that the pandemic is environmental in origin. We need to stick to implementation of Paris agreement,” she said.

Adesina also emphasised the need to respond to climate change. “By next year, 40% of the Bank’s portfolio will be in climate change, and 52% of that financing is in adaptation because that’s the challenge in Africa, rather than mitigation.”

The Victoria Forum convenes discussions to tackle global challenges under the leadership of the University of Victoria’s Gustavson School of Business in Canada. The inaugural forum was held in 2017.

The Victoria Forum 2020, cohosted by the Senate of Canada and the University of Victoria, comprises plenary and roundtable sessions on a range of pandemic-related themes. Sessions include Bridging Public and Private Investment for Resilient Economics and Inclusive Recovery and Moving Beyond Divides: Towards a More Sustainable and Fairer Future for Local Communities and the Global Community.

The Victoria Forum 2020 is taking place 12-13 and 19 November.

About the African Development Bank Group

The African Development Bank Group is Africa’s premier development finance institution. It comprises three distinct entities: the African Development Bank (AfDB), the African Development Fund (ADF) and the Nigeria Trust Fund (NTF). On the ground in 41 African countries with an external office in Japan, the Bank contributes to the economic development and the social progress of its 54 regional member states. For more information: www.afdb.org

Contact: Olufemi Terry | Communication and External Relations Department |
African Development Bank | email: [email protected]

Trial Met Primary Composite Endpoint of Reduction in Heart Failure Events or Cardiovascular Death; Did Not Meet Secondary Endpoints Including Reduction in Cardiovascular Death

Effect of Omecamtiv Mecarbil Consistent Across Most Prespecified Subgroups 
with Potentially Greater Treatment Effect in Patients with Lower Ejection Fraction at Higher Risk

Cytokinetics to Host Investor/Media Event and Webcast on November 13, 2020 at 1:00 PM ET

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the primary results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 event-driven cardiovascular outcomes clinical trial of omecamtiv mecarbil. The results were presented by John Teerlink, M.D., Professor of Medicine, University of California San Francisco, Director of Heart Failure, San Francisco Veterans Affairs Medical Center and Executive Committee Chair, GALACTIC-HF, in a Late Breaking Clinical Trial session at the American Heart Association (AHA) Scientific Sessions 2020, and were simultaneously published in the New England Journal of Medicine.¹

GALACTIC-HF, one of the largest Phase 3 global cardiovascular outcomes trials in heart failure ever conducted, enrolled 8,256 patients who were at risk of hospitalization and death, despite being well treated on standard of care therapy. After a median duration of follow-up of 21.8 months, the trial demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care. A first primary endpoint event occurred in 1,523 of 4,120 patients (37.0%) in the omecamtiv mecarbil group and in 1,607 of 4,112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI] 0.86, 0.99; p=0.025). This effect was observed without evidence of an increase in the overall rates of myocardial ischemic events, ventricular arrhythmias or death from cardiovascular or all causes.

The statistically significant reduction in the composite of heart failure events or cardiovascular deaths, without significant imbalances in the overall incidence of adverse events across treatment arms, was observed in one of the broadest and most diverse range of patients enrolled in a contemporary heart failure trial. GALACTIC-HF included both inpatients and outpatients, and with a high representation of participants with moderate to severe heart failure symptoms as well as lower ejection fraction, systolic blood pressure and renal function.

No reduction in the secondary endpoint of time to CV death was observed. Death from cardiovascular causes occurred in 808 (19.6%) patients treated with omecamtiv mecarbil and 798 patients (19.4%) assigned to placebo (hazard ratio, 1.01; 95% CI, 0.92 to 1.11; p=0.86). The pre-specified analysis of change from baseline to week 24 in the KCCQ total symptom score by randomization setting (inpatient mean difference [95% CI]: 2.50 [0.54, 4.46], outpatient mean difference: -0.46 [-1.40, 0.48], joint P = 0.028) did not meet the significance threshold of P=0.002 based upon the multiplicity control testing procedure. No other secondary endpoints were met in accordance with the prespecified statistical analysis.

The effect of omecamtiv mecarbil was consistent across most prespecified subgroups and with a potentially greater treatment effect suggested in patients with a lower left ventricular ejection fraction (LVEF ≤28%, n=>4,000, hazard ratio, 0.84; 95% CI 0.77, 0.92; interaction p=0.003). Omecamtiv mecarbil also significantly decreased NT-proBNP concentrations by 10% (95% CI 6-14%) at Week 24 compared to placebo.

“Heart failure remains a growing clinical and economic burden as our global population continues to age,” said John Teerlink, M.D. “Results from GALACTIC-HF demonstrate that the selective cardiac myosin activator omecamtiv mecarbil, which previously had been shown to improve cardiac performance, can meaningfully improve patient outcomes. The results also suggest that heart failure patients from a large pre-specified subgroup with more severely reduced systolic function may benefit more from this novel investigational medicine, and is an observation aligned with its primary pharmacologic effect to increase cardiac function.”

“We are pleased that GALACTIC-HF, a landmark clinical trial that enrolled one of the broadest range of both inpatients and outpatients studied in contemporary heart failure trials, demonstrated a positive effect on its overall primary efficacy endpoint and that treatment with omecamtiv mecarbil may especially benefit those with more reduced ejection fraction without an imbalance in the overall incidence of adverse events,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “We look forward to continuing to discuss next steps in this program with Amgen to inform a potential path forward.”

The overall safety profile of omecamtiv mecarbil in GALACTIC-HF appears to be consistent with data from previous trials. Adverse events and treatment discontinuation of study drug were balanced between the treatment arms. In general, the overall rates of myocardial ischemia, ventricular arrhythmias and death were similar between treatment and placebo groups. Additionally, there was no significant difference in the change in systolic blood pressure between baseline and at 24 or 48 weeks between the omecamtiv mecarbil and placebo groups. There was a small but significant decrease in heart rate in participants assigned to omecamtiv mecarbil compared to placebo at both timepoints. Median cardiac troponin I concentration increased 4 ng/L (95% CI 3-5; limit of detection, 6 ng/L) from baseline with omecamtiv mecarbil compared to placebo.

Investor/Media Event

Cytokinetics will host an investor and media event on November 13, 2020 at 1:00 PM ET that will be simultaneously webcast and can be accessed at https://wsw.com/webcast/cc/cytk/1388034 as well as from the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. An archived replay of the virtual event will be available via Cytokinetics’ website until November 13, 2021.

GALACTIC-HF: Trial Design

GALACTIC-HF,² (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), one of the largest Phase 3 global cardiovascular outcomes studies in heart failure ever conducted, enrolled 8,256 patients in 35 countries across 945 sites with HFrEF, New York Heart Association (NYHA) class II-IV, left ventricular ejection fraction (LVEF) ≤35%, elevated natriuretic peptides and either current hospitalization for heart failure or history of hospitalization or emergency department visit for heart failure within a year. Patients were randomized to either oral placebo or a starting dose of 25 mg omecamtiv mecarbil twice daily (maintenance dose of 50 mg, 37.5 mg, or 25 mg twice daily) guided by pharmacokinetic-guided dose selection. A blood test, the QMS Omecamtiv Mecarbil Immunoassay (the OM Test) was used to measure plasma levels of omecamtiv mecarbil in each patient in order to guide selection of the appropriate maintenance dose.

The primary composite endpoint of this double-blind, placebo-controlled, event-driven trial was time to CV death or first heart failure event (heart failure hospitalization and other urgent treatment for heart failure). Secondary endpoints were: time to CV death, patient reported outcomes (measured by Kansas City Cardiomyopathy Questionnaire [KCCQ] Total Symptom Score [TSS]), time to first heart failure hospitalization and time to all-cause death.

About Omecamtiv Mecarbil and the Phase 3 Clinical Trials Program

Omecamtiv mecarbil is an investigational selective cardiac myosin activator, the first of a novel class of myotropes³ designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole. Preclinical research has shown that omecamtiv mecarbil increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption.^4-6 Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction.

Omecamtiv mecarbil is being developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF) under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier. Omecamtiv mecarbil is the subject of a comprehensive Phase 3 clinical trials program composed of GALACTIC-HF and METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity.

About Heart Failure

Heart failure is a grievous condition that affects more than 64 million people worldwide⁷ about half of whom have reduced left ventricular function.^8,9 It is the leading cause of hospitalization and readmission in people age 65 and older.^{10, 11} Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.¹² An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure will die within five years of initial hospitalization.^13,14

About Cytokinetics and Amgen Collaboration

In 2006, Cytokinetics and Amgen entered into a strategic alliance to discover, develop and commercialize novel small molecule therapeutics designed to activate the cardiac sarcomere for the potential treatment of heart failure. Omecamtiv mecarbil is being developed by Amgen in collaboration with Cytokinetics, with funding and strategic support from Servier. Amgen holds an exclusive, worldwide license to omecamtiv mecarbil and related compounds, subject to Cytokinetics’ specified development and commercialization rights. Cytokinetics is eligible for pre-commercialization and commercialization milestone payments and royalties that escalate based on increasing levels of annual net sales of products commercialized under the agreement. Cytokinetics has co-invested with Amgen in the Phase 3 development program of omecamtiv mecarbil in exchange for increased royalties from Amgen on worldwide sales of omecamtiv mecarbil outside Japan and co-promotion rights in institutional care settings in North America. Amgen has also entered an alliance with Servier for exclusive commercialization rights for omecamtiv mecarbil in Europe as well as the Commonwealth of Independent States, including Russia. Servier contributes funding for development and provides strategic support to the program.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF, of which topline results were recently reported, and METEORIC-HF, which is ongoing. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA) for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is considering potential advancement of reldesemtiv to Phase 3 pending ongoing regulatory interactions. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to research, develop and commercialize other novel mechanism skeletal sarcomere activators (not including FSTAs). Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies. Cytokinetics has granted Ji Xing Pharmaceuticals Limited an exclusive license to develop and commercialize CK-274 in China and Taiwan, in accordance with Cytokinetics’ planned global registration programs. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the GALACTIC-HF clinical trial; statements relating to the METEORIC-HF clinical trial; the potential benefits of omecamtiv mecarbil, including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; the potential approval of omecamtiv mecarbil by the FDA or any other regulatory authority; Cytokinetics’ and its partners’ research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics’ other drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen’s decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics’ collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Communications, Investor Relations
(415) 290-7757

References

1. Teerlink J et al. NEJM. 2020
2. Teerlink JR., Diaz R., Felker GM., et al. Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF. JACC Heart Fail. 2020 Apr; 8(4):329-340. doi: 10.1016/j.jchf.2019.12.001.Epub 2020 Feb 6.
3. Psotka MA, Gottlieb SS, Francis GS et al. Cardiac Calcitropes, Myotropes, and Mitotropes. JACC. 2019; 73:2345-53.
4. Planelles-Herrero VJ, Hartman JJ, Robert-Paganin J. et al. Mechanistic and structural basis for activation of cardiac myosin force production by omecamtiv mecarbil. Nat Commun. 2017;8:190.
5. Shen YT, Malik FI, Zhao X, et al. Improvement of cardiac function by a cardiac myosin activator in conscious dogs with systolic heart failure. Circ Heart Fail. 2010; 3: 522-27.
6. Malik FI, Hartman JJ, Elias KA, Morgan BP, Rodriguez H, Brejc K, Anderson RL, Sueoka SH, Lee KH, Finer JT, Sakowicz R. Cardiac myosin activation: a potential therapeutic approach for systolic heart failure. Science. 2011 Mar 18;331(6023):1439-43.
7. James et al. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Lancet 2018; 392: 1789–858.
8. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128:e240-e327. 
9. Ponikowski  P, Voors  AA, Anker  SD, et al. 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016;37:2129–2200.
10. Roger VL. Epidemiology of Heart Failure. Circulation Research. 2013;113:646-659, originally published August 29, 2013. Doi: 10.1161/CIRCRESAHA.113.300268.
11. Kilgore M, Patel HK, Kielhorn A et al. Economic burden of hospitalizations of Medicare beneficiaries with heart failure. Risk Manag Healthc Policy. 2017; 10: 63-70. 
12. Jhund PS, MacIntyre K, Simpson CR, et al. Long-Term Trends in First Hospitalization for Heart Failure and Subsequent Survival Between 1986 and 2003. Circulation. 2009;119:515-523.
13. Benjamin EJ, Virani SS, Callaway CW et al. Heart Disease and Stroke Statistics—2018 Update: A Report From the American Heart Association. Circulation. 2018;137:e67-e492. 
14. Roger VL, Weston SA, Redfield MM, et al. Trends in Heart Failure Incidence and Survival in a Community-Based Population. JAMA. 2004;292:344-350.

An infographic accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f899c63c-8605-44cf-8c16-c9ab93640611

WILMINGTON, Del., Nov. 13, 2020 (GLOBE NEWSWIRE) — Rigrodsky & Long, P.A. announces that it is investigating Akers Biosciences, Inc. (“Akers”) (NASDAQ GS: AKER) regarding possible breaches of fiduciary duties and other violations of law related to Akers’ agreement to merge with MYMD Pharmaceuticals, Inc. (“MYMD”). Under the terms of the agreement, Akers will issue a number of shares of Akers common stock to MYMD’s shareholders. Upon completion of the merger, Akers’ shareholders will own approximately 20% of the combined company and MYMD’s shareholders will own approximately 80% of the combined company.

To learn more about this investigation and your rights, visit: https://www.rl-legal.com/cases-akers-biosciences-inc.

You may also contact Seth D. Rigrodsky or Gina M. Serra cost and obligation free at (888) 969-4242 or [email protected].

Rigrodsky & Long, P.A., with offices in Delaware and New York, has recovered hundreds of millions of dollars on behalf of investors and achieved substantial corporate governance reforms in securities fraud and corporate class actions nationwide.

Attorney advertising.  Prior results do not guarantee a similar outcome.

CONTACT:         

Rigrodsky & Long, P.A.
Seth D. Rigrodsky
Gina M. Serra
(888) 969-4242 (Toll Free)
(302) 295-5310
Fax: (302) 654-7530
[email protected]
https://rl-legal.com

BRIDGEWATER, N.J., Nov. 13, 2020 (GLOBE NEWSWIRE) — Clinical Genomics (“CG” or the “Company”), a provider of cancer diagnostic solutions, including liquid biopsy tests, today announced that Novitas Solutions (“Novitas”), a Medicare Administrative Contractor (“MAC”) processing claims for Medicare, updated its Local Coverage Determination applicable to biomarkers in oncology, including COLVERA, the Company’s liquid biopsy test to detect biomarkers associated with minimal residual disease and recurrence for patients who have been diagnosed and treated for colorectal cancer (“CRC”).

Novitas updated the Local Coverage Determination (“LCD”): Biomarkers for Oncology (L35396) to allow Medicare coverage for COLVERA for medically necessary tests performed on or after July 1, 2020. This determination applies to patients across the United States covered by the Centers for Medicare and Medicaid Services (“CMS”) whose claims for testing are submitted by Clinical Genomics in New Jersey. Medicare beneficiaries currently account for more than 50% of the COLVERA tests ordered by physicians and other licensed clinicians.

Subsequent to the publication of the updated coverage determination, Clinical Genomics has received payment for numerous COLVERA tests that meet appropriate use criteria.

“Receiving Medicare coverage for COLVERA represents a significant milestone for our Company, as we advance toward full commercialization of this important diagnostic. Over the past several years, our employees, both in the U.S. and Australia, in partnership with our academic and physician collaborators, have worked very hard to build the evidence base that supports the clinical validity and utility of COLVERA. We would also like to thank the patients who participated in our clinical trials for their efforts to help us expand access to this potentially life-saving test,” stated Betsy Hanna, CEO of Clinical Genomics.

“This is an important achievement for CG and positions us well to advance our commercial expansion plans, including building awareness of COLVERA’s clinical advantages over the current guidelines-recommended standard of care and pursuing reimbursement for patients covered under a wide range of health insurance plans,” concluded Hanna.

COLVERA is a blood test that detects aberrant methylation in two genes, BCAT1 and IKZF1, found at a high frequency (>95%) in colorectal cancer (CRC) tumor tissue. Identification of these tumor-specific epigenetic changes within a blood sample provides a simple, non-invasive way to detect the presence of CRC-associated circulating tumor DNA (ctDNA).

COLVERA can aid physicians in managing patients previously diagnosed with CRC and treated with curative intent who are undergoing follow-up testing to assess the presence of residual or recurrent CRC. COLVERA has been demonstrated in multiple peer-reviewed studies in the U.S. and Australia to offer significantly improved performance compared to the current guidelines-recommended standard of care blood test, carcinoembryonic antigen (CEA).¹

About
Clinical Genomics

Clinical Genomics is dedicated to improving patient outcomes through early detection of colorectal cancer. Clinical Genomics’ products span the full spectrum of colorectal cancer testing from screening to post-treatment monitoring. Clinical Genomics is committed to developing and delivering solutions that provide physicians and their patients with information to help guide earlier and better treatment decisions in cancer care management.

About COLVERA

COLVERA is a Laboratory Developed Test supplied by Clinical Genomics Pathology Inc. a CLIA Certified, CAP accredited laboratory in Bridgewater, NJ, USA. COLVERA is the first of its kind blood test to detect circulating tumor DNA for molecular residual disease (“MRD”) assessment and recurrence monitoring in patients previously diagnosed with colorectal cancer. COLVERA targets aberrant methylation of two genes (BCAT1 and IKZF1) and is mutation agnostic. COLVERA does not require any form of tissue biopsy prior to use. Introduced in 2017, COLVERA has been ordered by hundreds of colorectal surgeons and medical oncologists across the United States.

About Colorectal Cancer

Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer-related deaths in the United States, with more than 140,000 people per year expected to be diagnosed with CRC and over 50,000 succumbing to the disease annually. For patients who survive, 30%-50% will experience a recurrence, most within the first two to three years of primary treatment. On average, the lifetime risk of developing colorectal cancer is about one in 23 for men and women combined; however, this varies widely according to individual risk factors.

Future Matters and
Forward Looking
Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements that address expectations or projections about the future, including statements about product development, market position, expected expenditures and financial results, are forward-looking statements. Some of the forward-looking statements may be identified by words like “expects,” “anticipates,” “plans,” “intends,” “projects,” “indicates,” and similar expressions. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. These statements are not guarantees of future performance and involve a number of risks, uncertainties and assumptions. Accordingly, the Company’s actual results or performance may differ significantly, positively or negatively, from forward-looking statements made herein. Unanticipated events and circumstances are likely to occur. Factors that might cause such differences include, but are not limited to, anticipated funding proving to be unavailable; intense competition in the market resulting in lower than anticipated revenues or higher than anticipated costs; and general economic conditions, such as the rate of employment, inflation, interest rates and the condition of the capital markets. This list of factors is not exclusive. The Company undertakes no obligation to update any forward-looking statements.

Investor Relations for
Clinical Genomics
:

Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: [email protected] 

COLVERA is a trademark of Clinical Genomics PTY Ltd.

¹ See Musher, Benjamin L. et al. “Evaluation of Circulating Tumor DNA for Methylated BCAT1 and IKZF1to Detect Recurrence of Stage II/Stage III Colorectal Cancer (CRC),” Cancer Epidemiology and Prevention Biomarkers (2020); and Symonds, Erin L. et al. “Circulating epigenetic biomarkers for detection of recurrent colorectal cancer,” Cancer 126.7 (2020): 1460-1469.

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Nov. 13, 2020 (GLOBE NEWSWIRE) — CENTOGENE (Nasdaq: CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, today announced the nomination of Dr. Jonathan G. Sheldon as a member of the Supervisory Board, which will be proposed to the shareholders at an upcoming Extraordinary General Meeting (EGM). Dr. Sheldon will also serve with immediate effect as a member ad interim of the Company’s Supervisory Board.

“We are excited to welcome Dr. Jonathan G. Sheldon as a new member of the Supervisory Board. Jonathan has been instrumental in building QIAGEN’s leading data interpretation offerings for scientific and clinical decision support. We look forward to benefiting from his contributions as we advance the use of CENTOGENE’s data repositories, which we believe to be by far the most comprehensive collection of such data in rare diseases,” stated Dr. Flemming Ornskov, Chairman of the Supervisory Board of CENTOGENE.

Dr. Sheldon serves as Senior Vice President of the Digital Insights Business Area at QIAGEN N.V. (Nasdaq: QGEN; Frankfurt: QIA), a leading provider of molecular sample and assay technologies. Since 2018, he led QIAGEN’s Digital Insights global business. Prior to this, Jonathan served as Global Vice President at Oracle Health Sciences from 2010-2017.

About CENTOGENE

CENTOGENE engages in diagnosis and research around rare diseases transforming real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies. Our goal is to bring rationality to treatment decisions and to accelerate the development of new orphan drugs by using our extensive rare disease knowledge, including epidemiological and clinical data, as well as innovative biomarkers. CENTOGENE has developed a global proprietary rare disease platform based on our real-world data repository with over 3.6 billion weighted data points from approximately 570,000 patients representing over 120 different countries as of August 31, 2020.

The Company’s platform includes epidemiologic, phenotypic, and genetic data that reflects a global population, and also a biobank of these patients’ blood samples. CENTOGENE believes this represents the only platform that comprehensively analyzes multi-level data to improve the understanding of rare hereditary diseases, which can aid in the identification of patients and improve our pharmaceutical partners’ ability to bring orphan drugs to the market. As of August 31, 2020, the Company collaborated with over 40 pharmaceutical partners covering over 45 different rare diseases.

Important Notice and Disclaimer

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of our strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project” or “expect,” “may,” “will,” “would,” “could” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the Company. However, these forward-looking statements are not a guarantee of our performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, such as negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, the effects of the COVID-19 pandemic on our business and results of operations, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in our industry, the expense and uncertainty of regulatory approval, including from the U.S. Food and Drug Administration, our reliance on third parties and collaboration partners, including our ability to manage growth and enter into new client relationships, our dependency on the rare disease industry, our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations of our operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the Company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The Company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please refer to the Risk Factors section in our Annual Report for the year ended December 31, 2019 on Form 20-F filed with the SEC on April 23, 2020, Form 6-K containing our financial results for the three months ended March 31, 2020, filed with the SEC on June 15, 2020 and other current reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

Media Contact:

CENTOGENE

Ben Legg
Corporate Communications
[email protected]

FTI Consulting

Bridie Lawlor O’Boyle
+1.917.929.5684
[email protected]

WYOMISSING, Pa., Nov. 13, 2020 (GLOBE NEWSWIRE) — Carl Pettinato was only 17 when he enlisted in the US Navy. He served with honor from 1969 to 1971. While serving in Vietnam his patrol boat hit an underwater landmine. He was blown into the water suffering a broken back and severe head injuries. He was saved by a helicopter medic who pulled him out of the water. Sadly, several of his fellow shipmates and close friends lost their lives that day. After suffering these almost life ending injuries he was honorably discharged.

Over the years the injury to his back has taken its toll. He has rods and pins in his back, has to walk with a cane, and can no longer stand up straight. Due to the constant pain from his back, he takes several different medications which has caused dry mouth and overtime that led to him losing his teeth. Sadly, the VA does not cover dentures let alone dental implants. So, when Carl heard about Berks Oral Surgery’s Veteran’s Day Benefit program, he wrote to them and asked for a new smile.

The Veterans Day Benefit program was started by Berks Oral surgery in 2017. Dr. David Winans started this program to help a local veteran restore their dentition. “Our practice has an immense appreciation for the men and women who have and continue to serve our country. We understand that many veterans struggle greatly with their oral health and it weighs heavily on their self-esteem. This is our small way of saying thank you for your sacrifice. It is truly a team effort, with many local members of the dental community joining in to make this a reality,” said Dr. Winans. This year Berks Oral Surgery also teamed up with Neocis, the maker of Yomi Robotics System to create a new smile for Mr. Pettinato.

Mr. Pettinato’s surgery was performed by Dr. Dave Winans and was done with the assistance of the Yomi Robotic Surgery System. Yomi is the first and only FDA cleared robotic assisted dental surgery system. Berks Oral Surgery is a pioneer in the field of dental robotics. Successfully placing dental implants requires careful pre-operative planning and a high degree of accuracy and precision.  Surgical robotic technology helps doctors to achieve these objectives. “Mr. Pettinato has given so much for his country I really wanted to ensure he has the best smile possible,” said Dr. Winans.

“I am really excited to have a new smile and I am looking forward to the self confidence that will come with being able to smile again,” said Mr. Pettinato.

About Berks Oral Surgery and Implant Center

Berks Oral Surgery, Ltd. is a full spectrum Oral and Maxillofacial Surgery practice of the highest quality, with special emphasis on dental implants. This year they are celebrating the 45th anniversary of their practice. They were founded by the late Dr. James J. Ciabattoni (1932-1994) in 1975. In that same year he was joined by Dr. Erwin H. Wolf, II and Dr. John J. Ciabattoni. Dr. Andrew M. Rowan joined the group in 1989 and Dr. Fred J. Ciabattoni came aboard in 1991. Dr. Steven D. Fallon joined the practice in 2007. Since 2013 three new doctors have joined the group: Dr. David L. Winans (2013), Dr. Geoffrey S. Zinberg (2015) & Dr. Ryan Calvi (2020). All of their doctors are Board Certified by the American Board of Oral and Maxillofacial Surgery. At Berks Oral Surgery their doctors have a combined experience of over 115 years!

About Neocis, Inc.

Neocis Inc. is a private company located in Miami, Florida that is transforming dental surgery with advanced robotics, with a vision of advancing healthcare through the latest technology. Neocis manufactures and markets Yomi®, the first and only robot-assisted surgical platform for the dental industry. Yomi uses haptic guidance and is also a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants. Neocis is venture-backed, including funding from Mithril Capital Management, Norwest Venture Partners, and robotic surgery industry pioneer Fred Moll. For more information visit www.Neocis.com.

Contacts:

Mike Hale
Berks Oral Surgery and Implant Center
Practice Administrator
610-374-4093
[email protected]

Cassie Hallberg
Vice President of Marketing, Neocis
(732) 688-8839
[email protected]

TORONTO, Nov. 13, 2020 (GLOBE NEWSWIRE) — Ninepoint Partners LP (“Ninepoint”) announced that each of the Ninepoint 2019 Flow-Through Limited Partnership (the “2019 Partnership”), Ninepoint 2019 Short Duration Flow-Through Limited Partnership (the “2019-II Partnership”) and Ninepoint 2020 Flow-Through Limited Partnership (the “2020 Partnership”, and together with the 2019 Partnership and the 2019-II Partnership, the “Partnerships” and each a “Partnership”), each managed by Ninepoint, will be proceeding with a tax-deferred transfer of the assets of the Partnership into Ninepoint Resource Class, a class of shares of Ninepoint Corporate Class Inc., an open-ended mutual fund corporation (the “Mutual Fund Rollover Transactions”). In exchange for the assets of the 2019 Partnership and the 2019-II Partnership, Ninepoint Resource Class will issue Series F shares to the Partnership, which will be distributed to limited partners of each Partnership in exchange for their limited partnership units of the Partnership. 

In exchange for the assets of the 2020 Partnership, Ninepoint Resource Class will issue Series A and Series F shares to the Partnership, which will be distributed to limited partners of the Partnership in exchange for their Class A and Class F limited partnership units of each of the National and the Québec portfolio of the Partnership.  Ninepoint has elected to conduct a Mutual Fund Rollover Transaction for the 2020 Partnership in advance of the liquidity event originally anticipated in early 2022 because it is expected that the 2020 Partnership will soon realize all tax benefits through its investment in resource issuers that have renounced their Canadian Exploration Expenses to the Partnership and accordingly limited partners can be provided with an earlier liquidity event during expected favourable market conditions.

Limited partners will receive shares of Ninepoint Resource Class with a value equal to the value of the units of the Partnership that they hold in exchange for such units.  The Mutual Fund Rollover Transactions will take place on or about February 5, 2021 after the close of business.  The Partnerships will be dissolved on or about March 31, 2021.

The investment objective of Ninepoint Resource Class is to seek to achieve long-term capital growth by investing primarily in equity and equity-related securities of companies in Canada and around the world that are involved directly or indirectly in the natural resources sector. Ninepoint is the manager of the Partnership and Ninepoint Resource Class. Sprott Asset Management LP is the sub-advisor to Ninepoint Resource Class.

Additional information about Ninepoint Resource Class is available in the simplified prospectus and annual information form of the fund at www.sedar.com and www.ninepoint.com.

About Ninepoint Partners LP

Based in Toronto, Ninepoint is one of Canada’s leading alternative investment management firms overseeing approximately $7 billion in assets under management and institutional contracts. Committed to helping investors explore innovative investment solutions that have the potential to enhance returns and manage portfolio risk, Ninepoint offers a diverse set of alternative strategies including North American Equity, Global Equity, Real Assets and Alternative Income.

If you have any questions or concerns, please do not hesitate to contact us at 1-866-299-9906 and [email protected].

Certain statements included in this news release constitute forward-looking statements, including, but not limited to, those identified by the expressions “expects”, “will” and similar expressions to the extent that they relate to a Partnership. The forward-looking statements are not historical facts but reflect the Partnership’s and Ninepoint’s current expectations regarding future results or events. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. Although the Partnership and Ninepoint believe the assumptions inherent in the forward-looking statements are reasonable, forward-looking statements are not guarantees of future performance and, accordingly, readers are cautioned not to place undue reliance on such statements due to the inherent uncertainty therein. Neither the Partnership, nor Ninepoint undertake any obligation to update publicly or otherwise revise any forward-looking statement or information whether as a result of new information, future events or other such factors which affect this information, except as required by law.