Market Newsdesk

DENVER, Nov. 16, 2020 (GLOBE NEWSWIRE) — First Western Financial, Inc. (NASDAQ: MYFW), a financial services holding company headquartered in Denver, Colorado (“First Western” or “the Company”), announced today that it has completed the sale of its Los Angeles-based fixed income portfolio management team (“LA fixed income team”) and certain related advisory and sub-advisory arrangements to Lido Advisors, LLC and Oakhurst Advisors, LLC.

On an ongoing basis, the sale of the LA fixed income team is expected to be earnings neutral to the Company, as the revenue decrease will be approximately in-line with the expense reduction. The sale is not expected to have an impact on First Western’s bank clients, but will reduce the Company’s assets under management by approximately $300 million.

The sale is expected to result in an estimated positive impact to the Company’s tangible common equity of approximately $3.0 million to $3.3 million.

Scott C. Wylie, CEO of First Western, said, “The sale of the LA fixed income team represents another important step in our efforts to optimize our cost structure and investment platform, while having a positive impact on our tangible book value per share. This transaction frees up capital and management resources that can be used to support the continued growth of more profitable areas of the Company and further enhance the strong earnings momentum that we have built this year. The LA fixed income team has produced strong investment performance, and our arrangement with Lido Advisors and Oakhurst will continue to provide First Western clients with full access to this team through advisory and sub-advisory relationships. This team will also benefit from the broader distribution platform that Lido Advisors and Oakhurst will provide.”

A
bout First Western Financial, Inc.

First Western is a financial services holding company headquartered in Denver, Colorado, with operations in Colorado, Arizona, Wyoming and California. First Western and its subsidiaries provide a fully integrated suite of wealth management services on a private trust bank platform, which includes a comprehensive selection of deposit, loan, trust, wealth planning and investment management products and services. First Western’s common stock is traded on the Nasdaq Global Select Market under the symbol “MYFW.” For more information, please visit www.myfw.com.

Forward-Looking Statements

Statements in this news release regarding our expectations and beliefs about our future financial performance and financial condition, as well as trends in our business and markets are “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “project,” “outlook,” or words of similar meaning, or future or conditional verbs such as “will,” “would,” “should,” “opportunity,” “could,” or “may.” The forward-looking statements in this news release are based on current information and on assumptions that we make about future events and circumstances that are subject to a number of risks and uncertainties that are often difficult to predict and beyond our control. As a result of those risks and uncertainties, our actual financial results in the future could differ, possibly materially, from those expressed in or implied by the forward-looking statements contained in this news release and could cause us to make changes to our future plans. Those risks and uncertainties include, without limitation, the COVID-19 pandemic and its effects; integration risks in connection with acquisitions; the risk of geographic concentration in Colorado, Arizona, Wyoming and California; the risk of changes in the economy affecting real estate values and liquidity; the risk in our ability to continue to originate residential real estate loans and sell such loans; risks specific to commercial loans and borrowers; the risk of claims and litigation pertaining to our fiduciary responsibilities; the risk of competition for investment managers and professionals; the risk of fluctuation in the value of our investment securities; the risk of changes in interest rates; and the risk of the adequacy of our allowance for loan losses and the risk in our ability to maintain a strong core deposit base or other low-cost funding sources. Additional information regarding these and other risks and uncertainties to which our business and future financial performance are subject is contained in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 12, 2020 (“Form 10-K”), and other documents we file with the SEC from time to time. We urge readers of this news release to review the “Risk Factors” section our Form 10-K and any updates to those risk factors set forth in our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and our other filings with the SEC. Also, our actual financial results in the future may differ from those currently expected due to additional risks and uncertainties of which we are not currently aware or which we do not currently view as, but in the future may become, material to our business or operating results. Due to these and other possible uncertainties and risks, readers are cautioned not to place undue reliance on the forward-looking statements contained in this news release, which speak only as of today’s date, or to make predictions based solely on historical financial performance. Any forward-looking statement speaks only as of the date on which it is made, and we do not undertake any obligation to update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

Contacts:

Financial Profiles, Inc.
Tony Rossi
310-622-8221

[email protected]

[email protected]

SAN ANTONIO, Nov. 16, 2020 (GLOBE NEWSWIRE) — Rackspace Technology Global, Inc. (the “Company”) today announced that is proposing to issue $550.00 million aggregate principal amount of senior notes due 2028 (the “Notes”) in a private offering that is exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”). The offering is subject to market conditions and other factors.

The Company intends to use the net proceeds from the offering, together with cash on hand, to fund the refinancing of all of the Company’s outstanding 8.625% Senior Notes due 2024 and to pay related fees and expenses.

The Notes are being offered only to persons reasonably believed to be qualified institutional buyers in reliance on Rule 144A under the Securities Act, and outside the United States, only to non-U.S. investors pursuant to Regulation S under the Securities Act. The Notes will not be registered under the Securities Act or any state securities laws and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from registration requirements or a transaction not subject to the registration requirements of the Securities Act or any state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offering, solicitation or sale would be unlawful.

About
Rackspace Technology

Rackspace Technology is a leading end-to-end multicloud technology services company. We design, build and operate our customers’ cloud environments across all major technology platforms, irrespective of technology stack or deployment model. We partner with our customers at every stage of their cloud journey, enabling them to modernize applications, build new products and adopt innovative technologies.

Rackspace Technology
Safe Harbor Statement: 

Some of the statements in this news release constitute “forward-looking statements” that do not directly or exclusively relate to historical facts. The forward-looking statements made in this release reflect the Company’s intentions, plans, expectations, assumptions and beliefs about future events and are subject to risks, uncertainties and other factors, many of which are outside of the Company’s control. Known risks include, among others, the risks included in Rackspace Technology, Inc.’s filings with the U.S. Securities and Exchange Commission. Because actual results could differ materially from the Company’s intentions, plans, expectations, assumptions and beliefs about the future, you are urged to view all forward-looking statements contained in this press release with caution. The Company does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact

Natalie Silva
Rackspace Technology Corporate Communications
[email protected] 

Joe Crivelli
Rackspace Technology Investor Relations
[email protected]

Fort Lauderdale, FL, Nov. 16, 2020 (GLOBE NEWSWIRE) — The Singing Machine Company, Inc. (“Singing Machine” or the “Company”) (OTCQX: SMDM) – the worldwide leader in consumer karaoke products – today announced its financial results for its second quarter ended September 30, 2020.

Second Quarter Snapshot:

• Net sales for the quarter increased by $3.1 million from $20.1 million to $23.2 million (15% increase).
• Gross profit margin increased by 0.9% from 28.1% to 29.0% (increase in gross profit of $1.1 million for the quarter).
• Operating expenses decreased by approximately $0.5 million from $4.8 million to $4.3 million for the quarter.
• During the quarter, the Company recognized a $0.9 million gain in Other Income from the proceeds of the insurance claim.
• Net income for the quarter was $2.4 million compared to $0.6 million in the same period last year (300% increase). Net income through the six-month period increased to $2.2 million compared to a $0.2 million loss over the same period last year.

Singing Machine reports net sales of approximately $23.3 million for the quarter-ended September 30, 2020 period compared to $20.1 million in the comparable quarter of the prior year. The increase in net sales was primarily due to increased demand for the Carpool Karaoke Microphone and extra demand of karaoke product to internet customers.

Gross profit margin increased by 0.9%to 29.0% compared to approximately 28.1% reported in the prior year. The increase in gross margin was mainly due to sales of its new Carpool Karaoke Microphone, which yielded greater margin than the traditional product mix.

Total operating expenses decreased by $0.5 million from $4.8 million in the prior year to $4.3 million for the current quarter. The decrease in expenses was primarily due to lowered marketing expenses and advertising allowances as well as no one-time expenses that were incurred last year as a result of the damaged goods claim. The remaining decrease in expenses was due to a reduction in travel and entertainment expenses associated with restricted travel due to the pandemic.

As a result, the Company reported a net income of $2.4 million compared to net income of $0.6 million in the prior year.

Management Commentary:

Gary Atkinson, Singing Machine CEO, commented, “This was a very strong quarter for Singing Machine. We saw double digit growth in topline sales and strong improvement to gross margin brought about primarily from increased demand for our Carpool Karaoke microphone that went viral over the summer. Further, we have done a tremendous job reducing inventory and turning it into cash, particularly our end-of-life models. All of this has come together to deliver a strong bottom line.”

Bernardo Melo, V.P. of Global Sales & Marketing commented, “The Singing Machine brand continues to be the trusted home karaoke brand for consumers. As the market saw an uptick in home entertainment, our products have exceeded the growth reported by NPD in the youth electronics category. We are also starting to see the beginning of the growth cycle that happens every few years in the Music category that benefits the sales of home karaoke products. We saw success in the category in the spring and summer which are traditionally not high demand times of year for karaoke. One key item that has contributed to that success is our Carpool Karaoke microphone. We experienced tremendous non-seasonal demand and had to rush some re-orders with the manufacturer to catch up with holiday demand. Early forecasts from some our year-round retail partners show that the demand will continue through our fiscal 4th quarter and well into fiscal 2022.”

Earnings Call Information:

The Company will host a conference call today, Monday, November 16, beginning at 1:00 pm Eastern time to discuss these results and answer questions. If you would like to participate on the call, please dial (800) 459-5346 and use conference ID: SMDM.

An audio rebroadcast of the call will be available later in the day after the earnings call and can be heard at: www.singingmachine.com/investors.

About The Singing Machine

Based in the U.S., Singing Machine^® is the North American leader in consumer karaoke products. The first to provide karaoke systems for home entertainment in the United States, the Company sells its products worldwide through major mass merchandisers and on-line retailers. We offer the industry’s widest line of at-home karaoke entertainment products, which allow consumers to find a machine that suits their needs and skill level. As the most recognized brand in karaoke, Singing Machine products incorporate the latest technology for singing practice, music listening, entertainment and social sharing. The Singing Machine provides consumers the best warranties in the industry and access to over 13,000 songs for streaming and download. Singing Machine products are sold through most major retailers in North America and also internationally. See www.singingmachine.com for more details.

Investor Relations Contact:

Brendan Hopkins
(407) 645-5295
[email protected] 
www.singingmachine.com
www.singingmachine.com/investors

Forward-Looking Statements

This press release contains forward‑looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward‑looking statements are based on current expectations, estimates and projections about the Company’s business based, in part, on assumptions made by management and include, but are not limited to statements about our financial statements for the fiscal year ended March 31, 2020. You should review our risk factors in our SEC filings which are incorporated herein by reference. Such forward‑looking statements speak only as of the date on which they are made and the company does not undertake any obligation to update any forward‑looking statement to reflect events or circumstances after the date of this release.

Anti-SARS-CoV-2 Neutralizing Antibodies Elicited in


All Eight TNX-1800 Vaccinated Animals

Skin Reaction or “Take,” a Validated Biomarker of Functional T cell Immunity, 


Elicited in All Eight TNX-1800 Vaccinated Animals

CHATHAM, N.J., Nov. 16, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced preliminary results following vaccination of non-human primates with TNX-1800 (modified horsepox virus, live vaccine), a live attenuated COVID-19 vaccine candidate engineered to express the SARS-CoV-2 (CoV-2) spike protein after vaccination. The research is part of an ongoing collaboration between Southern Research Institute, the University of Alberta and Tonix.

“We are pleased that all eight animals vaccinated with TNX-1800 manifested “takes”, a skin reaction which is a validated biomarker of functional T cell immunity, and that vaccination was associated with neutralizing antibodies in each case,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “‘Take’ has a long history as a validated biomarker for T cell immunity. ’Take‘ is important because it is otherwise difficult and costly to measure the T cell response to a vaccine. Vaccines that elicit a strong T cell response, like horsepox and closely related vaccinia, have been established to provide long-term, durable immunity and to block forward transmission. Single dose horsepox and vaccinia vaccination led to the eradication of smallpox, which, like CoV-2, is transmitted by the respiratory route. In the successful campaign to eradicate smallpox, ’take‘ was used as a biomarker for protective immunity.”

Dr. Lederman continued, “Our hope and our goal is to produce a vaccine that will provide long term immunity with a single dose using a proven technology that can be readily scaled up for manufacturing and that does not require a costly and cumbersome cold chain for distribution and storage. These results encourage us to advance TNX-1800 to human Phase 1 trials in 2021, when we expect to have Good Manufacturing Practice, or cGMP, quality TNX-1800 available. We have previously announced that our manufacturing partner is FUJIFILM Diosynth Biotechnologies.”

Key features and results:

• 
  STUDY DESIGN
  : This on-going study of non-human primates compares TNX-1800 (modified horsepox virus encoding CoV-2 spike protein) to TNX-801 (horsepox virus, live vaccine) at two doses. A control group received a placebo. Each of these five groups (TNX-1800 high and low dose; TNX-801 high and low dose and placebo) includes four animals.
• 
  NEUTRALIZING ANTI-CoV-2 ANTIBODIES
  : At day 14 after a single vaccination, all eight of the TNX-1800 vaccinated animals made anti-CoV-2 neutralizing antibodies (≥1:40 titer) and, as expected, none of the eight TNX-801 vaccinated control animals, or any of the four animals in the placebo group, made anti-CoV-2 neutralizing antibodies (≤1:10 titer). The level of neutralizing anti-CoV-2 antibody production was similar between the low and high dose TNX-1800 groups ((1 x 10⁶ Plaque Forming Units [PFU]) and 3 x 10⁶ PFU, respectively).
• 
  TOLERABILITY
  :TNX-1800 and TNX-801 were well tolerated at both doses.                
• 
  SKIN
  
  
  
  TAKE
  
  
  
  BIOMARKER
  : Further, as an expected additional outcome, all 16 animals vaccinated with either dose of TNX-1800 or the control TNX-801 manifested a “take”, or cutaneous response, signaling that the horsepox vector elicited a strong T cell immune response.
• 
  DOSE:
  These results support the expectation that TNX-1800 at the low dose of 1 x 10⁶ PFU is an appropriate dose for a one-shot vaccine in humans, and indicate that 100 doses per vial is the target format for commercialization, which is suited to manufacturing and distribution at large scale.
• 
  CONCLUSIONS
  : Together, these data show that TNX-1800 induces a strong immune response to CoV-2 in non-human primates. These data confirm that “take” is a biomarker of a strong immunological response to TNX-1800’s vector, horsepox virus vaccine, and also indicate that “take” is predictive of a neutralizing antibody response to TNX-1800’s cargo COVID-19 antigen, which is the CoV-2 spike protein.
• 
  NEXT PHASE
  : In the second phase of the study, the TNX-1800 vaccinated and control animals will be challenged with CoV-2. Results are expected in the first quarter of 2021.

About
TNX
-1800

TNX-1800 is a live modified horsepox virus vaccine for percutaneous administration that is designed to express the Spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response. Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor. Tonix’s TNX-1800 vaccine candidate is administered percutaneously using a two-pronged, or “bifurcated” needle. TNX-1800 is based on a horsepox vector, which is a live replicating, attenuated virus that elicits a strong immune response. The major cutaneous reaction or “take” to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s. The “take” is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola. Tonix’s proprietary horsepox vector is believed to be more closely related to Jenner’s vaccinia vaccine than modern vaccinia vaccines, which appear to have evolved by deletions and mutations to a phenotype of larger plaque size in tissue culture and greater virulence in mice. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice¹. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials.

¹Noyce RS, et al. (2018) PLoS One. 13(1):e0188453

About Southern Research

Founded in 1941, Southern Research (SR) is an independent, 501(c)(3) nonprofit, scientific research organization with more than 400 scientists and engineers working across three divisions: Drug Discovery, Drug Development, and Engineering. SR has supported the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries. SR works on behalf of the National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA and other major aerospace firms, utility companies, and other external academic, industry and government agencies. SR pursues entrepreneurial and collaborative initiatives to develop and maintain a pipeline of intellectual property and innovative technologies that positively impact real-world problems. SR has numerous ongoing drug discovery programs, which encompass drug discovery programs to combat various forms of cancer, Alzheimer’s, schizophrenia, opioid use disorder, human immunodeficiency virus, disease, Parkinson’s, tuberculosis, influenza, and others. SR’s strong history, which includes over 75 years of successful collaborations to solve complex problems, has led to the discovery of seven FDA-approved cancer drugs—a number rivaling any other U.S. research institute. Furthermore, experts at SR are well-equipped to assist with the challenging landscapes of drug design and development technologies and market viability. SR is headquartered in Birmingham, Alabama with additional laboratories and offices in Frederick, Maryland.

Further information about SR can be found at https://southernresearch.org/

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year and the first quarter of 2021. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.. Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19 but using bovine parainfluenza as the vector. Tonix’s lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects topline data in the Phase 3 RELIEF study in the fourth quarter of 2020. Tonix is also currently enrolling participants in the Phase 3 RALLY study for the management of fibromyalgia using TNX-102 SL, and the results are expected in second half of 2021. TNX-102 SL is also in development for PTSD, agitation in Alzheimer’s disease (AAD) and alcohol use disorder (AUD). The PTSD program is in Phase 3 development, while AAD and AUD are Phase 2 ready The AAD program has FDA Fast Track designation. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix’s preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

*TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

**TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the “SEC”) on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts                                

Jessica Morris (corporate)

Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Olipriya Das, Ph.D. (media)

Russo Partners
[email protected]
(646) 942-5588

Peter Vozzo (investors)

Westwicke
[email protected] 
(443) 213-0505

• PDUFA
  target action
  date
  is
  May 14
  , 2021

• FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the
  application

• Pegcetacoplan demonstrated superiority to eculizumab in improving hemoglobin levels in Phase 3 PEGASUS head-to-head study as well as substantial improvements in other clinical measures

• Apellis plans to open an early access program
  in the United States
  for pegcetacoplan for p
  eople living
  with PNH
  

WALTHAM, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation for the New Drug Application (NDA) for pegcetacoplan for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The Prescription Drug User Fee Act (PDUFA) target action date is May 14, 2021. The FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.

“For more than a decade, the only treatment options available for PNH have been C5 inhibitors, and many patients still suffer from persistently low hemoglobin, often resulting in debilitating fatigue and frequent transfusions. The NDA priority review takes us one step closer to bringing pegcetacoplan, a targeted C3 therapy with the potential to redefine PNH treatment, to patients in need,” said Federico Grossi, M.D., Ph.D., chief medical officer of Apellis. “The data in the application validate the broad potential of targeting C3, and we continue to advance several registrational studies in serious diseases with few or no treatments.” 

The NDA submission is based on results from the head-to-head Phase 3 PEGASUS study, which met its primary endpoint, demonstrating the superiority of pegcetacoplan to eculizumab with a statistically significant improvement in hemoglobin levels at 16 weeks. The data also demonstrated higher normalization rates across key markers of hemolysis and a clinically meaningful improvement in Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue score. The safety profile of pegcetacoplan was comparable to eculizumab in the study.

Priority Review designation is granted to marketing applications for medicines that treat a serious condition and if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. Pegcetacoplan was previously granted Fast Track designation by the FDA for the treatment of PNH.

Apellis plans to open an early access program (EAP) in the United States for pegcetacoplan for patients with PNH who are experiencing ongoing disease activity despite treatment with C5 inhibition. The EAP will be available for a limited time while the FDA is reviewing the pegcetacoplan NDA. EAPs are potential pathways for patients with life-threatening or serious diseases to access investigational therapies outside of clinical trials when no comparable or satisfactory alternative therapy options are available. More information on the EAP is available at https://apellis.com/for-patients/early-access-program/.

About the PEGASUS Study

The PEGASUS study (APL2-302; NCT03500549) is a multi-center, randomized, active-comparator controlled Phase 3 study in 80 adults with paroxysmal nocturnal hemoglobinuria (PNH). The primary objective of this study was to establish the efficacy and safety of pegcetacoplan compared to eculizumab. Participants must have been on eculizumab (stable for at least three months) with a hemoglobin level of <10.5 g/dL at the screening visit. During the four-week run-in, patients were dosed with 1080 mg of pegcetacoplan twice weekly (n=41) in addition to their current dose of eculizumab. During the 16-week randomized, controlled period, patients were randomized to receive either 1080 mg of pegcetacoplan twice weekly or their current dose of eculizumab (n=39). All participants completing the randomized controlled period entered the open-label pegcetacoplan treatment period.

The study was conducted in collaboration with SFJ Pharmaceuticals, who supported the development of pegcetacoplan in PNH. SFJ is a global drug development company, which provides a unique and highly customized co-development partnering model for the world’s top pharmaceutical and biotechnology companies.

About Pegcetacoplan (APL-2) 
Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan is a synthetic cyclic peptide conjugated to a polyethylene glycol polymer that binds specifically to C3 and C3b. Apellis is evaluating pegcetacoplan in several clinical studies across hematology, ophthalmology, nephrology, and neurology. Pegcetacoplan was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and the treatment of geographic atrophy, and received orphan drug designation for the treatment of C3G by the FDA and European Medicines Agency. For additional information regarding our clinical trials, visit https://apellis.com/our-science/clinical-trials.

About Paroxysmal Nocturnal Hemoglobinuria (PNH) 
PNH is a rare, chronic, life-threatening blood disorder characterized by the destruction of oxygen-carrying red blood cells through extravascular and intravascular hemolysis. Persistently low hemoglobin can result in frequent transfusions and debilitating symptoms such as severe fatigue, hemoglobinuria, and difficulty breathing (dyspnea). A retrospective analysis shows that, even on eculizumab, approximately 72% of people with PNH have anemia, a key indicator of ongoing hemolysis.¹ The analysis also finds that 36% of patients require one or more transfusions a year and 16% require three or more.¹

About the Apellis and
Sobi
Collaboration

Apellis and Sobi entered a collaboration to develop and commercialize systemic pegcetacoplan in October 2020. The companies have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialization rights for systemic pegcetacoplan, and Apellis has exclusive U.S. commercialization rights for systemic pegcetacoplan and retains worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy (GA).

About Apellis 
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies. Leaders in targeted C3 therapies, we aim to develop transformative therapies for a broad range of debilitating diseases that are driven by excessive activation of the complement cascade, including those within hematology, ophthalmology, and nephrology. For more information, please visit http://apellis.com.

Apellis Forward-Looking Statement 
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the implications of preliminary clinical data. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether the company’s clinical trials will be fully enrolled and completed when anticipated; whether preliminary or interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials will be indicative of results that will be generated in future clinical trials; whether pegcetacoplan will successfully advance through the clinical trial process on a timely basis, or at all; whether the results of the company’s clinical trials will warrant regulatory submissions and whether pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for GA, PNH, CAD, C3G, IC-MPGN, ALS or any other indication when expected or at all; whether, if Apellis’ products receive approval, they will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of Apellis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 2, 2020 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact: 
Lissa Pavluk 
[email protected] 
617.977.6764

Investor Contact:

Argot Partners
[email protected]
+1 212.600.1902

1.  McKinley C. Extravascular Hemolysis Due to C3-Loading in Patients with PNH Treated with Eculizumab: Defining the Clinical Syndrome. Blood. 2017;130:3471.

SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, announced today that management will be participating in two upcoming virtual investor conferences and invites investors to participate by webcast. Please see additional details below:

• Jefferies 2020 Virtual London Healthcare Conference, November 17-19, 2020

  Management will deliver a company presentation on Thursday, November 19th at 2:20 p.m. ET and will also be available for one-on-one meetings. A live and archived webcast of the presentation will be available on the Investors section of the Vaxart website: https://investors.vaxart.com/events-presentations

• Piper Sandler 32nd Annual Virtual Healthcare Conference, December 1-3, 2020 

  Management will present in a fireside chat format and will be available for one-on-one meetings. The presentations will be available prior to the dates of the conference. A replay of the fireside chat will be available in the Investors section of the Vaxart website: https://investors.vaxart.com/events-presentations

About Vaxart

Vaxart is a clinical-stage biotechnology company focused on developing oral tablet vaccines designed to generate mucosal and systemic immune responses that protect against a wide range of infectious diseases and have the potential to provide sterilizing immunity for diseases such as COVID-19. Vaxart believes that a room temperature stable tablet is easier to distribute, store and administer than injectable vaccines and may provide a significantly faster response to a pandemic than injectable vaccines, enabling a greater portion of the population to be protected. Vaxart’s development programs include oral tablet vaccines that are designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV). For more information, please visit www.vaxart.com.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates, and preclinical and clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations relating to Vaxart’s relationship with Emergent, KindredBio and AMS including their ability to produce bulk cGMP vaccines and the timing thereof; and Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for mucosal pathogens such as norovirus, flu and RSV, as well as coronaviruses such as SARS, MERS and SARS-CoV-2. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Operation Warp Speed may not result in a positive financial impact on Vaxart’s financial results that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to resolve pending legal matters; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

Contacts:
Media Relations	Investor Relations
Gloria Gasaatura LifeSci Communications Tel: (646) 970-4688 [email protected]	David R. Holmes LifeSci Advisors, LLC Tel: (646) 970-4995 [email protected]

SAN ANTONIO, Nov. 16, 2020 (GLOBE NEWSWIRE) — Rackspace Technology Global, Inc. (the “Company”) today announced that it is commencing a tender offer (the “Tender Offer”) to purchase for cash any and all of its outstanding 8.625% Senior Notes due 2024 (the “Notes”).

The Tender Offer is subject to the terms and conditions set forth in the Offer to Purchase, dated Monday, November 16, 2020, relating thereto (the “Offer to Purchase”).

The Notes and other information relating to the Tender Offer are listed in the table below. The Offer to Purchase more fully sets forth the terms of the Tender Offer.

Title of Security	CUSIP Number	Principal Amount Outstanding		Tender Offer Consideration (1)		Early Tender Payment (1)		Total Consideration (1) (2)
8.625% Senior Notes due 2024	45332JAA0 / U45083AA7	$519,232,000		$1,015.00		$30.00		$1,045.00

(1)	Per $1,000 principal amount of Notes and excluding accrued and unpaid interest, which will be paid in addition to the Total Consideration or Tender Offer Consideration, as applicable.
(2)	Includes the Early Tender Payment.

Holders who validly tender their Notes prior to 5:00 p.m., New York City time, on Monday, November 30, 2020 (the “Early Tender Time”) will be eligible to receive total consideration of $1,045.00 per $1,000 principal amount of Notes tendered, which includes an early tender payment of $30.00 per $1,000 principal amount of Notes tendered. Holders must validly tender and not validly withdraw their Notes, and have their Notes accepted for purchase in the Tender Offer, at or prior to the Early Tender Time in order to be eligible to receive the total consideration, including the early tender payment.

The Tender Offer is scheduled to expire at the end of the day, 12:00 midnight, New York City Time, on Monday, December 14, 2020, unless extended or earlier terminated by the Company (the “Expiration Time”).

Holders tendering their Notes after the Early Tender Time but at or prior to the Expiration Time will receive the tender offer consideration of $1,015.00 per $1,000 principal amount of Notes tendered.

Upon the terms and conditions described in the Offer to Purchase, payment for Notes accepted for purchase will be made:

	(1)	with respect to the Notes validly tendered and not validly withdrawn at or prior to the Early Tender Time, promptly after the Early Tender Time (which is currently expected to be on or about Tuesday, December 1, 2020, unless the Early Tender Time is extended), and
	(2)	with respect to Notes validly tendered after the Early Tender Time but at or prior to the Expiration Time, promptly after the Expiration Time (which is currently expected to be on or about Wednesday, December 16, 2020, unless the Tender Offer is extended).

Holders whose Notes are accepted for purchase will receive accrued and unpaid interest from the last interest payment date to, but not including, the applicable settlement date.

Tendered Notes may be withdrawn at any time on or prior to 5:00 p.m., New York City time, on Monday, November 30, 2020, unless extended by the Company (the “Withdrawal Deadline”). Holders of Notes who tender their Notes after the Withdrawal Deadline, but at or prior to the Expiration Time, may not, subject to limited exceptions, withdraw their tendered Notes.

The Tender Offer is conditioned upon the satisfaction of certain conditions, including the closing of an offering of new notes by the Company on terms satisfactory to the Company and in an aggregate principal amount satisfactory to the Company. Subject to applicable law, the Company may also terminate the Tender Offer at any time in its sole discretion.

Concurrently with the launch of the Tender Offer, pursuant to the indenture governing the Notes, the Company issued a conditional notice of redemption pursuant to which it will redeem any Notes not purchased in the Tender Offer at a price of 104.313% of the principal amount thereof, plus accrued and unpaid interest to but excluding the redemption date of December 16, 2020, subject to the completion of an offering of notes on or prior to the redemption date by the Company on terms satisfactory to the Company and in an aggregate principal amount satisfactory to the Company.

The Company has retained Citigroup Global Markets Inc. to act as the dealer manager (the “Dealer Manager”) for the Tender Offer. Global Bondholder Services Corporation will act as the Information Agent and the Depositary for the Tender Offer. Questions regarding the Tender Offer should be directed to Citigroup Global Markets Inc. at (800) 558-3745 (toll-free) or (212) 723-6106 (collect). Requests for documentation should be directed to Global Bondholder Services Corporation at (212) 430-3774 (for banks and brokers) or (866) 470-3900 (for all others).

This announcement is for informational purposes only. This announcement is not an offer to purchase or a solicitation of an offer to purchase the Notes. The Tender Offer is being made solely pursuant to the Offer to Purchase. The Tender Offer is not being made to holders of Notes in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction. In any jurisdiction in which the securities laws or blue sky laws require the Tender Offer to be made by a licensed broker or dealer, the Tender Offer will be deemed to be made on behalf of the Company by the Dealer Manager, or one or more registered brokers or dealers that are licensed under the laws of such jurisdiction.

None of the Company or its affiliates, the Dealer Manager, the Information Agent, the Depositary or the trustee with respect to the Notes is making any recommendation as to whether holders should tender any Notes in response to the Tender Offer, and neither the Company nor any such other person has authorized any person to make any such recommendation. Holders must make their own decision as to whether to tender any of their Notes, and, if so, the principal amount of Notes to tender.

About
Rackspace Technology

Rackspace Technology is a leading end-to-end multicloud technology services company. We design, build and operate our customers’ cloud environments across all major technology platforms, irrespective of technology stack or deployment model. We partner with our customers at every stage of their cloud journey, enabling them to modernize applications, build new products and adopt innovative technologies.

Rackspace Technology
Safe Harbor Statement: 

Some of the statements in this news release constitute “forward-looking statements” that do not directly or exclusively relate to historical facts. The forward-looking statements made in this release reflect the Company’s intentions, plans, expectations, assumptions and beliefs about future events and are subject to risks, uncertainties and other factors, many of which are outside of the Company’s control. Known risks include, among others, the risks included in Rackspace Technology, Inc.’s filings with the U.S. Securities and Exchange Commission. Because actual results could differ materially from the Company’s intentions, plans, expectations, assumptions and beliefs about the future, you are urged to view all forward-looking statements contained in this press release with caution. The Company does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

IR Contact

Joe Crivelli
Rackspace
Technology Investor Relations
[email protected]

PR Contact
Natalie Silva
Rackspace Technology
Corporate Communications
[email protected]

 

TORONTO and MINNEAPOLIS, Minn., Nov. 16, 2020 (GLOBE NEWSWIRE) — According to the Ceridian Pulse of Talent report, the majority of the North American workforce could be moving on to new job prospects, underscoring the growing importance of modern employee experiences and retention strategies in the future of work.

The report revealed:

• The majority of the North American workforce is looking for new job opportunities or would consider moving jobs if approached by another company (US: 64%, CAN: 68%)
• Younger workers, under the age of 30, are the most likely to be on the move (US: 75%, CAN: 87%)

“The past year has thrust the future of work upon us, and with it comes an urgency to implement intelligent technologies that create value within this new reality,” said Susan Tohyama, Chief Human Resources Officer, Ceridian. “Employee experience is no exception. What was once a nice-to-have workplace perk is now inextricably tied to business resilience and sustainable growth.”

While
p
ay
r
emains
i
mportant,
e
ngagement
m
ost
i
mportant
f
actor for
r
etention

The report revealed that pay is the top factor that entices talent to apply for a role (US and CAN: 36%), followed by good work life balance (US: 19%, CAN 18%), and the overall work environment (US:12% and CAN: 13%). However, when asked what was the most important factor that keeps people with an employer, engaging work topped the list.

Tohyama added that while turnover is an expensive consequence of failing to invest in employee engagement, the impact to a company’s bottom line may be even greater. According to Gallup, organizations that are the best in engaging their employees achieve earnings-per-share growth that is more than four times that of their competitors.

Ceridian offers the following tips to design a modern employee experience for the new world of work:

• Reimagine pay:
  O
  n-demand
  pay
  solutions offer employees the flexibility to access their wages as they earn and need them, helping to improve financial wellness, attract top talent, and drive engagement. The ability to get paid on-demand is quickly becoming a basic workplace requirement.
• Leverage employee surveys to understand your people: Gather first-hand employee feedback at any time through quick pulse checks, or go deeper with quarterly or annual engagement surveys. As work from home becomes the norm, keeping a pulse on employee sentiment is increasingly important for global organizations.
• Provide a
  modern
  employee experience: Provide a simple, modern experience for leaders and employees by using a central hub. Employees can take control of their own work experience and find the information and tools they need to be productive wherever they live and work.

To download the 2021 Pulse of Talent Report, please click here.

Methodology:
Nielsen conducted the Pulse of Talent research study via an online questionnaire, from August 4 to 27, 2020 among 5,010 respondents, aged 18+ across Canada, U.S., U.K. Australia and New Zealand who are members of Nielsen’s online panel. Results were weighted by respondents’ demographics based on census data to align with the proportions of the population
.

About Ceridian

Ceridian
. Makes Work Life Better™.

Ceridian is a global human capital management software company. Dayforce, our flagship cloud HCM platform, provides human resources, payroll, benefits, workforce management, and talent management functionality. Our platform is used to optimize management of the entire employee lifecycle, including attracting, engaging, paying, deploying, and developing people. Ceridian has solutions for organizations of all sizes. Visit Ceridian.com or follow us @Ceridian.

Media Contact:

Matthew Duffin
[email protected]
+1-647-248-0752 

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Dow Jones content is now available through FIS’s MarketMap Terminal, under an expanded partnership that will give financial professionals access to premium news, data and analysis from Dow Jones’s trusted brands.

From today, MarketMap users will have access to daily content from Dow Jones Newswires, The Wall Street Journal, Barron’s, MarketWatch and WSJ Pro. This news and analysis is supplemented by Dow Jones Calendar Live data feed, which covers press conferences, scheduled announcements and data releases from more than 1,000 economic events and 11,500 companies.

MarketMap users will also benefit from the addition of NewsPlus, Dow Jones’s customizable, real-time news dashboard. Available in 12 languages, NewsPlus displays both real-time streaming news together with content curated by Dow Jones’s global newsroom to provide an instant snapshot of markets throughout the trading day.

“We pride ourselves on offering the real-time news and information our clients need,” said Nasser Khodri, EVP, Sell-side, Capital Markets, FIS. “Integrating Dow Jones premium content offers even more value to our users, helping them keep up with news, data and insights from the brands they trust — without ever leaving the MarketMap terminal.”

“As a long-time partner with FIS, we are excited to expand access to our premium content and data to all MarketMap users,” said Joanna Appleton, Head of Partnerships and Licensing EMEA at Dow Jones. “This agreement significantly extends the reach of Dow Jones’s trusted journalism and data to the global financial community, helping them to uncover market opportunities and inform their investment decisions.”

More information about FIS MarketMap is available here.

About Dow Jones

Dow Jones is a global provider of news and business information, delivering content to consumers and organizations around the world across multiple formats, including print, digital, mobile and live events. Dow Jones has produced unrivaled quality content for more than 130 years and today has one of the world’s largest news gathering operations globally. It produces leading publications and products including the flagship Wall Street Journal, America’s largest newspaper by paid circulation; Factiva, Barron’s, MarketWatch, Financial News, Dow Jones Risk & Compliance, and Dow Jones Newswires. Dow Jones is a division of News Corp (Nasdaq: NWS, NWSA; ASX: NWS, NWSLV).

About FIS

FIS is a leading provider of technology solutions for merchants, banks and capital markets firms globally. Our employees are dedicated to advancing the way the world pays, banks and invests by applying our scale, deep expertise and data-driven insights. We help our clients use technology in innovative ways to solve business-critical challenges and deliver superior experiences for their customers. Headquartered in Jacksonville, Florida, FIS is a Fortune 500^® company and is a member of Standard & Poor’s 500^® Index. To learn more, visit www.fisglobal.com. Follow FIS on Facebook, LinkedIn and Twitter (@FISGlobal).

Media Contact

Louise Mead
[email protected]

Silence Therapeutics Presents Positive Pre-Clinical Data for SLN360 for the Treatment of Elevated Lipoprotein(a) at American Heart Association 2020

• 
  Pre-clinical safety data show no adverse or off-target effects and targeted biodistribution of the company’s wholly owned gene-silencing candidate SLN360
  
• 
  Profile supports SLN360’s progression to in-human testing for the treatment of elevated lipoprotein(a), an independent risk factor for premature heart disease, heart attack and stroke
  

16 November 2020

LONDON, Silence Therapeutics plc, AIM:SLN and Nasdaq: SLN (“Silence” or “the Company”), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, has presented positive pre-clinical safety data for its wholly owned lead product candidate, SLN360, at the American Heart Association (AHA)’s virtual Scientific Sessions 2020, being held 14-16 November.¹ The results, available here, demonstrated that the potent and sustained reduction of lipoprotein(a) – Lp(a) – levels in in vitro and animal models treated with SLN360 was not associated with any adverse or off-target effects.¹

Giles Campion, Head of R&D and Chief Medical Officer of Silence Therapeutics commented: “The strength of our pre-clinical safety data, coupled with the efficacy data presented at the AHA congress this time last year, demonstrates the precision with which we are able to target the appropriate gene and deliver robust knockdown of Lp(a) levels with long duration of action. Safety is always important but particularly when a therapy has the potential to be administered to a large population as a long-term preventative measure. These results give us confidence to move SLN360 into the clinic, to develop a transformational medicine for the millions of people facing a higher risk of cardiovascular disease due to elevated Lp(a).”

Recent evidence has shown that elevated Lp(a) serum levels is a key independent, genetic and causal risk factor for premature heart disease, heart attack and stroke.² It is estimated to affect 20% of individuals worldwide, with limited treatment strategies currently available. By directly targeting and silencing the LPA gene within the liver, SLN360 is designed to lower levels of Lp(a), which in turn is expected to lower the risk of premature cardiovascular disease.

Results presented today show that the distribution of SLN360 is confined to the liver (target organ) and kidney (route of elimination) as intended, with levels of SLN360 in other organs (including reproductive organs) less than 1% of peak liver levels. Its restricted biodistribution and the absence of off-target effects supports the progression of SLN360 to in-human testing. 

The Phase I APOLLO trial is now recruiting (NCT04606602), to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic response of SLN360 in people with elevated Lp(a). If successful in clinical trials, SLN360 may provide a novel therapeutic approach to address Lp(a)-related cardiovascular disorders. More information on the trial can be found here.

References

1. Rider D, et al. Pre-clinical Safety Assessment of SLN360, A Novel Short Interfering Ribonucleic Acid Targeting LPA, presented at the American Heart Association (AHA) Scientific Sessions, November 2020.
2. Tsimikas S, A Test in Context: Lipoprotein(a): Diagnosis, Prognosis, Controversies, and Emerging Therapies, J Am Coll Cardiol. 2017;69(6):692-711.

Enquiries:

Silence Therapeutics plc Gem Hopkins, Head of IR and Corporate Communications [email protected]	Tel:  +1 (646) 637-3208
Investec Bank plc (Nominated Adviser and Broker) Daniel Adams/Gary Clarence	Tel:  +44 (0) 20 7597 5970
European IR Consilium Strategic Communications Mary-Jane Elliott/Chris Welsh/Angela Gray [email protected]	Tel: +44 (0) 20 3709 5700
U.S. IR Westwicke Partners Peter Vozzo [email protected]	Tel: +1 (443) 213-0505

About SLN360

Silence’s wholly owned lead product candidate, SLN360, is a gene ‘silencing’ therapy – one that is designed to temporarily block a specific gene’s message that would otherwise trigger an unwanted effect. In this case, it aims to ‘silence’ LPA, a gene that tells the body to make a specific protein that is only found in Lp(a). By silencing LPA, the levels of Lp(a) are lowered, which in turn is expected to lower the risk of heart diseases, heart attacks and strokes. Silence is evaluating SLN360 in its APOLLO Phase 1 dose escalation study designed to assess the safety, tolerability, pharmacokinetic and pharmacodynamic response of SLN360 in people with elevated Lp(a). More information on the trial can be found here.

About Lipoprotein(a)

Lipoprotein(a), known as Lp(a) for short, is a particle made by the liver, which consists of cholesterol, fats and proteins. Most people have some Lp(a) in their body, but about 1 in 5 people have high levels of Lp(a), because of a specific gene variation in their DNA. Most people are unaware if they have elevated Lp(a). People living with elevated Lp(a) have a higher risk of developing early heart disease, heart attacks and strokes. Most standard cholesterol tests do not currently include screening for Lp(a). Current medicines that are used to lower other lipid levels in the blood do not have a meaningful effect on Lp(a) and are less effective overall in people with high levels of Lp(a).

About Silence Therapeutics

Silence Therapeutics is developing a new generation of medicines by harnessing the body’s natural mechanism of RNA interference, or RNAi, to inhibit the expression of specific target genes thought to play a role in the pathology of diseases with significant unmet medical need. Silence’s proprietary technology can be used to engineer short interfering ribonucleic acids (siRNAs) that bind specifically to and silence, through the RNAi pathway, almost any gene in the human genome to which siRNA can be delivered. Silence’s wholly owned product candidates include SLN360 designed to address the high and prevalent unmet medical need in reducing cardiovascular risk in people born with high levels of Lipoprotein(a) and SLN124 to address beta-thalassemia and myelodysplastic syndrome. Silence is also developing SLN500, a C3 targeting programme, in partnership with Mallinckrodt Pharmaceuticals to reduce the expression of the C3 protein for the treatment of complement pathway-mediated diseases.  Silence maintains ongoing research and collaborations with AstraZeneca, Mallinckrodt Pharmaceuticals and Takeda. For more information, please visit: https://www.silence-therapeutics.com/

Forward-Looking Statements

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