Market Newsdesk

LOS ANGELES, Nov. 13, 2020 (GLOBE NEWSWIRE) — Glancy Prongay & Murray LLP (“GPM”) reminds investors of the upcoming December 4, 2020 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired Precigen, Inc. (“Precigen” or the “Company”) f/k/a Intrexon Corporation (“Intrexon”) (NASDAQ: PGEN, XON) securities between May 10, 2017 and September 25, 2020, inclusive (the “Class Period”).

If you suffered a loss on your Precigen investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/precigen-inc/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at shareholders@glancylaw.com or visit our website at www.glancylaw.com to learn more about your rights.

The Company develops technologies using synthetic biology, an evolving discipline that applies engineering principles to biological systems to enable design-based control of cellular function for a specific purpose. Its methane bioconversion platform (“MBP”) purports to convert natural gas into commercial end products, such as isobutanol for gasoline blending, 2,3 Butanediol (“2,3 BDO”) for conversion to synthetic rubber, and 1,4 Butanediol for polyester.

Between May and November 2017, the Company touted that its MBP achieved yields of 2,3 BDO at profitable levels using “current natural gas and product prices.” The Company then engaged in discussions with potential partners, including strategic and financial companies, to seize the purported $100 billion market opportunity.

However, on February 28, 2019, the Company disclosed “that there is substantial doubt about its ability to continue as a going concern” because it lacked sufficient funding for operations beyond 12 months.

On this news, the Company’s share price fell $2.91, or 36%, to close at $5.06 per share on March 1, 2019, on unusually heavy trading volume. The stock price continued to fall during the next trading session by $0.92, or 18%, to close at $4.14 per share on March 4, 2019, on unusually heavy trading volume.

Then, on August 8, 2019, after the market closed, the Company announced that it would contribute the MBP and all its associated technologies and facilities to a newly formed company called MBP Titan, LLC. Though the Company would begin with a supermajority equity stake, the Company expected “to be dilutive in this enterprise.”

On this news, the Company’s share price fell $0.67, or 8.8%, to close at $6.95 per share on August 9, 2019, on unusually heavy trading volume.

Then, on March 2, 2020, after the market closed, the Company disclosed that it had been under investigation by the SEC since October 2018 “concerning the Company’s disclosures regarding its methane bioconversion platform.”

On this news, the Company’s share price fell $0.67, or 17%, to close at $3.24 per share on March 3, 2020, on unusually heavy trading volume.

On August 10, 2020, after the market closed, the Company disclosed that it had “suspended MBP Titan’s operations” as it “assess[ed] potential next steps relating to this intellectual property and MBP Titan’s other long-lived assets.”

On this news, the Company’s share price fell $0.52, or 10%, to close at $4.60 per share on August 11, 2020, on unusually heavy trading volume.

On September 25, 2020, investors learned why the Company had not been able to capitalize the MBP, “the most valuable biotechnology ever created.” Specifically, the SEC issued a cease-and-desist order in connection with misleading statements the Company had issued in 2017: the yields from MBP had been achieved using pure methane as a feedstock, rather than natural gas as the Company had claimed. Because pure methane gas costs $650 per unit, whereas natural gas costs $3 per unit, the MBP was not producing results at commercially profitable rates.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company used pure methane, rather than natural gas, as the feedstock to achieve the reported results from its methane bioconversion platform; (2) that yields from natural gas as a feedstock were substantially lower than yields using pure methane; (3) that, due to the substantial price difference between pure methane and natural gas, pure methane was not a commercially viable feedstock; (4) that, due to the high costs of pure methane, the Company could not sustain operations of the methane bioconversion platform without pursuing financial alternatives; (5) that, due to the reduced yields from natural gas and high costs of pure methane, the Company could not find a financial or strategic partner for its methane conversion platform; (6) that, as a result of the foregoing, the Company was forced to divest its methane bioconversion platform and associated intellectual property, allowing the Company to focus on its other strategic assets; (7) that the Company was under investigation by the SEC; and (8) that, as a result of the foregoing, Defendants’ public statements were materially false and misleading at all relevant times.

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If you purchased or otherwise acquired the Company’s securities during the Class Period, you may move the Court no later than December 4, 2020 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Charles Linehan, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to [email protected], or visit our website at www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.   

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Contacts

Glancy Prongay & Murray LLP, Los Angeles
Charles H. Linehan, 310-201-9150 or 888-773-9224
1925 Century Park East, Suite 2100
Los Angeles, CA 90067
www.glancylaw.com  
[email protected]

BENSALEM, Pa., Nov. 13, 2020 (GLOBE NEWSWIRE) —

Law Offices of Howard G. Smith reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies. Investors have until the deadlines listed below to file a lead plaintiff motion.

Investors suffering losses on their investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in these class actions at 888-638-4847 or by email to [email protected].

GoHealth, Inc. (NASDAQ: GOCO)
IPO: July 2020
Lead Plaintiff Deadline: November 20, 2020

The complaint alleges that Defendants made materially false and/or misleading statements and/or failed to disclose that at the time of the IPO: (1) the Medicare insurance industry was undergoing a period of elevated churn, which had begun in the first half of 2020; (2) GoHealth suffered from a higher risk of customer churn due to its unique business model and limited carrier base; (3) GoHealth suffered from degradations in customer persistency and retention as a result of elevated industry churn, vulnerabilities that arose from the Company’s concentrated carrier business model, and its efforts to expand into new geographies, develop new carrier partnerships and worsening product mix; (4) GoHealth had entered into materially less favorable revenue sharing arrangements with its external sales agents; and (5) these adverse financial and operational trends were internally projected by GoHealth to continue and worsen following the IPO. 

NextCure, Inc. (NASDAQ: NXTC)
Class Period: November 5, 2019 – July 14, 2020
Lead Plaintiff Deadline: November 20, 2020

Shareholders with $100,000 losses or more are encouraged to contact the firm
 

The complaint filed alleges that Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) NextCure possessed NC318 data that showed a lack of efficacy and objective responses; (2) as a result, NC318 was not, in fact, effective in treating most tumor types; (3) as a result, the NC318 application was proving to be limited (if even useful at all); (4) as a result of the foregoing, there was a significant realizable risk that NC318 would not be nearly as popular as then-existing blockbuster drugs, such as Keytruda.   

Wrap Technologies, Inc. (NASDAQ: WRTC)
Class Period: April 29, 2020 – September 23, 2020
Lead Plaintiff Deadline: November 23, 2020

The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that there were limited instances in which the Company’s BolaWrap could possibly be used because it requires a minimum of 10 feet between the officer and the suspect; (2) that, as a result, the BolaWrap was reasonably unlikely to be effective in most circumstances; (3) that the LAPD sought extensions of the pilot program because they needed a larger sample size to assess the effectiveness of the BolaWrap; (4) that the LAPD had not found the BolaWrap to be useful or effective during its pilot program; (5) that, as a result, the Company had not received positive feedback from the LAPD about the BolaWrap and therefore it was unlikely that the Company would secure a sizeable contract with the LAPD; and (6) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Golar LNG Limited (NASDAQ: GLNG)
Class Period: April 30, 2020 – September 24, 2020
Lead Plaintiff Deadline: November 24, 2020

The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that certain employees, including Hygo’s Chief Executive Officer, had bribed third parties, thereby violating anti-bribery policies; (2) that, as a result, the Company was likely to face regulatory scrutiny and possible penalties; (3) that, as a result of the foregoing reputational harm, Hygo’s valuation ahead of its IPO would be significantly impaired; and (4) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis. 

To be a member of these class actions, you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about these class actions, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to [email protected], or visit our website at www.howardsmithlaw.com.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Contacts

Law Offices of Howard G. Smith
Howard G. Smith, Esquire
215-638-4847
888-638-4847
[email protected]
www.howardsmithlaw.com

RANCHO CUCAMONGA, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) — The parent company of Auto-Graphics, Inc. (A-G), Agent Information Software (AIFS) released their earnings for the third quarter of 2020, ending September 30, 2020.   AIFS’ sub-company Auto-Graphics, Inc., is an industry-leading provider of library automation software. A-G was the first to provide Cloud-based library resource sharing solutions.  

In spite of the increasing COVID-19 pandemic, AIFS reported a YTD net income of $250k with an EBITDA of $847k that represented 21.1% of sales at quarter end. Cash flow remained strong YTD as the company increased its focus on costs. AIFS reported EPS of $0.06 on weighted average shares outstanding of 4,474,577.

The company’s versatile AGent Library Software Platform continues to provide solutions that empower libraries across North America, to provide more products and services to their communities.   A-G had success in cross selling SHAREit, VERSO and MONTAGE to its existing base of customers who needed to provide enhanced services during the pandemic. In addition to company completed an important new implementation of SHAREit as part of another statewide resource sharing initiative.

About
Agent Information Software

Founded in 1950 and operating under the name Auto-Graphics, Inc. since 1969, Agent Information Software, Inc. (AIS) came about in 2010 to become Auto-Graphics, Inc. parent company. AIS develops innovative information and data management solutions for multiple platforms that are standards-compliant, built on open systems architecture and available through the Software as a Service (SaaS) hosted delivery model.

AIS’ technical ingenuity and reputation for service excellence make us a trusted partner to more than 11,000 libraries, throughout North America. Customers across multiple industries use their information and data management systems, including a range of library markets such as public, academic, school, special and consortia, and supports the needs of customers in the legal, financial, publishing, aerospace, and manufacturing markets. For more information, please visit www.agentinformationsoftware.com or www.auto-graphics.com.

FOR IMMEDIATE
RELEASE

Media Contact: Bryan Straight

Auto‐Graphics, Inc.

(909) 569‐1535

[email protected]

Boca Raton, FL, Nov. 13, 2020 (GLOBE NEWSWIRE) — Companies increasingly recognize the value of delivering their learning assets outside the four walls of the organization. These audiences can include employees outside company headquarters or in remote locations as well as non-employees, such as customers, channel partners, distributors, value-added resellers and franchisees.

Extended enterprise learning takes up a relatively small chunk of the L&D budget (60% of companies say it accounts for less than 10%), but presents a great opportunity for organizations to build their brand, improve customer relationships and generate revenue. On the whole, organizations that deliver learning to the extended enterprise are satisfied with the results they get.

“Given the large amount of extended enterprise learning, it’s remarkable that 56% of companies say their extended enterprise learning efforts are either effective or highly effective,” said Brandon Hall Group CEO Mike Cooke. “This is notable because rarely in our research do more than half of organizations rate other, more internally facing learning efforts this effective.”

“Clearly, there is room for improvement but the fact that more companies say they are effective than those saying they are only somewhat effective is impressive,” said Brandon Hall Group Principal Learning Analyst David Wentworth.

Why is this aspect of learning and development more effective than others? Click here to view Brandon Hall Groups 2020 Extended Enterprise Study Research Data Highlights, which includes the current state of extended enterprise, as well as analysis, critical questions that organizations need to answer and Brandon Hall Group’s point of view on the research.

-About Brandon Hall Group-

Brandon Hall Group is the world’s only professional-development company that provides data, research, insights and certification to Learning and Talent professionals and organizations. The best companies in the world rely on Brandon Hall Group to help create future-proof employee-development plans for the new era of work and management.

For more than 27 years, BHG empowers, recognizes and certifies excellence in organizations throughout the world, driving the development of more than 10,000,000 employees and executives. Our annual HCM Excellence Awards program was the first to recognize and celebrate organizations for learning and talent, and as the industry’s gold standard is known as the “Academy Awards of Human Capital Management.”

Brandon Hall Group’s cloud-based platform delivers evidence-based insights in Learning and Development, Talent Management, Leadership Development, Diversity and Inclusion, Talent Acquisition and HR/Workforce Management for corporate organizations and HCM solution providers.

David Forry
Brandon Hall Group
5613538082
[email protected]

CALGARY, Alberta, Nov. 13, 2020 (GLOBE NEWSWIRE) — Shaw Communications Inc. today announced that it is continuing to invest in British Columbia to create better retail experiences for connectivity shoppers in Vancouver, Langley, and Nanaimo.

Shaw opened the doors on its 2,025-square-foot retail store at Woodgrove Centre (6631 N Island Hwy) in Nanaimo this week. The new store in Nanaimo follows the opening of a 2,295-square-foot retail store in Langley at Willowbrook Shopping Centre (19705 Fraser Hwy) and another retail store at Shaw Tower in Vancouver (1067 West Cordova Street).

These new retail locations offer a contemporary and inviting environment for customers to explore Shaw’s latest products and services, including Shaw Mobile and Shaw Fibre+ Gig 1.5 internet and other Shaw Internet plans. For customers, the mall is often the final stop on a shopping journey that begins with online research on the wide array of products and services available to meet their heightened need for affordable and fast connectivity.

“Shopping is all about creating a positive and informative experience, and our redesigned stores are where Shaw products and services come to life,” said Paul Deverell, President, Consumer, Shaw Communications. “We’re giving residents of Vancouver, Langley, and Nanaimo a superior experience as they look to fulfill their growing need for ultrafast home internet and affordable wireless services. Our new retail spaces are stunning to look at and provide safe places for customers to get trusted advice from our connectivity experts.”

Each new store offers an immersive setting for customers to learn more about Shaw products and services — either from an expert advisor or on their own using interactive demonstration walls and digital display stations. The displays are modern, backlit and uncluttered to ensure the latest technology is front and centre so that customers get a better feel for what they are taking home while adhering to all applicable COVID-19 safety protocols.

Shaw Mobile is now available in more than 140 locations across B.C. and Alberta, including 22 Shaw retail stores, 59 Walmart stores and 52 locations of The Mobile Shop in Real Canadian Superstore and T&T Supermarket grocery stores. Future retail openings in B.C. are planned to take place at high-traffic shopping destinations in West Vancouver, Prince George, and Victoria in the coming weeks.

Shaw began its multi-million-dollar retail expansion when it launched Shaw Mobile wireless services in British Columbia and Alberta in July 2020.

In addition to making it more convenient for customers to get the connectivity services they need, Shaw’s retail efforts are contributing to each community’s economic recovery from the COVID-19 pandemic by creating jobs at a time of high unemployment and working with Canadian suppliers wherever possible.

“Shaw Communications is a top employer in our City. We are delighted to recognize Shaw for continuing to grow its presence in Nanaimo and contributing to our city’s economic development through the opening of its newest retail location,” said Leonard Krog, Mayor, Nanaimo. “This further investment will make it easier for residents to get the affordable wireless services and strong home internet connection they are looking for.”

“In these unprecedented times, people need to stay in touch and have dependable access to vital information more than ever,” said Jack Froese, Mayor, Township of Langley. “Options that keep people connected — especially with affordability in mind — are greatly appreciated, and we are pleased to see Shaw investing in our community, expanding opportunities, and providing employment.”

Customers can visit Shaw.ca/contact-us/retail for a complete list of locations.

More information, including a complete list of pricing and packaging for Shaw Internet plans, including Fibre+ Gig 1.5, and Shaw Mobile plans, can be found at shawmobile.ca/plans as well as shaw.ca/internet.

About Shaw

Shaw Communications Inc. is a leading Canadian connectivity company. The Wireline division consists of Consumer and Business services. Consumer serves residential customers with broadband Internet, Shaw Go WiFi, video and digital phone. Business provides business customers with Internet, data, WiFi, digital phone and video services. The Wireless division provides wireless voice and LTE data services through an expanding and improving mobile wireless network infrastructure.

Shaw is traded on the Toronto and New York stock exchanges and is included in the S&P/TSX 60 Index (Symbol: TSX – SJR.B, SJR.PR.A, SJR.PR.B, NYSE – SJR, and TSXV – SJR.A). For more information, please visit www.shaw.ca

Caution Regarding Forward Looking Statements

Statements included in this news release that are not historic constitute “forward looking information” within the meaning of applicable securities laws. Such statements include, but are not limited to, statements concerning Shaw’s retail expansion, the opening and timing of opening of new retail locations in British Columbia, and/or the creation of new jobs in connection with the opening of new retail locations. These statements are based on assumptions made by Shaw that it believes are appropriate and reasonable in the circumstances, including without limitation, the forbearance of governments in implementing any emergency measures or changes in laws or regulations that may impact Shaw’s products or services, such as retail store closures in response to the ongoing COVID-19 pandemic.

Undue reliance should not be placed on any forward-looking statement. Many factors, including those not within Shaw’s control, may cause actual results to be materially different from the views expressed or implied by such forward-looking statements, including but not limited to: Shaw’s ability to access key suppliers and third-party service providers and their goods and services on commercially reasonable terms; changes in the general economic, market and business conditions; emergency measures implemented by any government; changes in laws, regulations and decisions by regulators that affect Shaw products or services, or the markets in which Shaw operates; and other factors described in Shaw’s 2020 Annual Report under the heading “Known Events, Trends, Risks and Uncertainties.” The foregoing is not an exhaustive list of all possible factors. Should one or more of these risks materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results may vary materially from those described herein. Any forward-looking statements contained herein speak only as of the date of this news release. Except as required by law, Shaw disclaims any obligation to update any forward-looking statement.

For media inquiries, please contact:

Shaw Communications Inc.
Chethan Lakshman, VP, External Affairs
(403) 930-8448
[email protected]

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