Market Newsdesk

Study will evaluate safety and immunogenicity of multiple distinct dosing regimens of norovirus oral vaccine candidate

Norovirus infects 15% of U.S. children under age five every year

Study results may inform the COVID-19 oral vaccine program

SOUTH SAN FRANCISCO, Calif., May 04, 2021 (GLOBE NEWSWIRE) — Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that it has enrolled the first subject in a Phase 1b boosting regimen trial of its norovirus vaccine candidate. This study is designed to evaluate the safety and immunogenicity of various dosing intervals for Vaxart’s candidate, which is the only clinical stage norovirus oral tablet vaccine actively being developed.

In a health economic study published in the American Journal of Preventative Medicine in January 2021, the negative economic impact to the U.S. of norovirus was estimated to be approximately $10.5 billion* annually. Annual vaccine costs with an efficacy of 75% were cost effective and cost saving at ≤$1,600 and ≤$1,300 per year, respectively, for preschool-aged children, and ≤$165 and ≤$100 per year, respectively, for older adults.

“Norovirus is a potentially fatal illness that affects around 20 million Americans annually. It has an enormous impact on young families with 15% of children under age five being infected every year in the United States,” said Andrei Floroiu, Vaxart’s chief executive officer. “The WHO designated norovirus as a priority disease for vaccine development, as it is a major public health problem with no approved vaccine available, having a multi-billion dollar annual impact in the US alone and significantly more globally.”

Sean Tucker, Ph.D., chief scientific officer of Vaxart commented, “This study will provide insight into the optimal booster timing to maximize immunogenicity and total response of our oral norovirus vaccine candidate. Additionally, the findings may provide important information into the overall dynamics of our platform technology that could guide future protocols for our other vaccine candidates, including our oral COVID-19 tablet vaccine candidate, which is estimated to enter Phase 2 clinical trials around mid-year.”

Norovirus is an enteric pathogen that infects epithelial cells of the small intestine. Vaxart’s VP1-based bivalent oral tablet vaccine candidate targets the norovirus GI.1 Norwalk and GII.4 Sydney strains, which are the predominant strains affecting humans.

The booster regimen trial is the second of four Vaxart norovirus trials that are ongoing or are planned for 2021. Vaxart is currently administering a second booster dose to a subset of subjects who had participated in the prior Phase 1b bivalent study. The Company is also scheduled to initiate an age escalation trial in subjects over 65 years old and plans to launch a Phase 2 challenge study later this year.

VXA-NVV-105 Phase Booster Regimen 1b Trial Design

The Phase 1b study is designed to enroll 30 subjects aged 18 to 55 years old. Subjects will be randomized into 3 cohorts: Cohort 1 will receive the vaccine candidate on day 1 and week 4 of the study; Cohort 2 will receive the vaccine candidate on day 1 and week 8 of the study; Cohort 3 will receive the vaccine candidate on day 1 and week 12 of the study. The endpoints are safety and immunogenicity. For more information, refer to ClinicalTrials.gov.

* Note: The $10.5 Billion annual economic impact of norovirus infections in the US includes both direct medical costs and indirect costs such as time off work, school, etc.

About Vaxart

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the Company to develop oral analogs of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

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 clinical results and trial data, potential insights from Vaxart’s Phase 1b norovirus study, the potential role of Vaxart’s platform technology expectations regarding the timing and nature of future developments and announcements, including those related to trials and studies; the potential applicability of results seen in our preclinical studies or trials to those that may be seen in humans or clinical trials; and Vaxart’s expectations with respect to the effectiveness of its product candidates. 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, 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 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.

• Over 10,000 meters of infill and expansion drilling completed to date
  
• First property-wide triaxial magnetic survey completed
• Drill target selection underway for regional exploration program
  

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION, DISTRIBUTION OR DISSEMINATION DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES

VANCOUVER, British Columbia, May 04, 2021 (GLOBE NEWSWIRE) — Mayfair Gold Corp. (“Mayfair” or the “Company”) (TSX-V: MFG) is pleased to provide an update on its fully funded 2021 ongoing gold exploration program on its 100% owned Fenn-Gib Project (“Fenn-Gib”), located 80 kilometers east of Timmins, in northern Ontario.

Infill and expansion drilling commenced within three weeks following the acquisition of Fenn-Gib and has progressed well, with over 10,000m of the planned 50,000m drill program completed to date. The drill program includes both infill and step-out drilling at 25m to 50m centers and is designed to expand the gold mineralized zones beyond the current resource.

Mayfair Gold President and CEO Patrick Evans commented: “We are very pleased with the excellent progress being made at Fenn-Gib. With three drill rigs active, we are currently well on track to achieve our planned 50,000m drill program.”

Mr. Evans added: “We are also pleased to have completed the first ever heli-borne high-resolution triaxial MAG survey at 75-metre spaced flight lines over both the North and South blocks at Fenn-Gib. Based on initial results, target selection has commenced and plans are underway to mobilize additional drill rigs to Fenn-Gib to support a regional exploration program.”

Although drilling at Fenn-Gib is progressing very well, the turnaround time at the assay laboratories remains slow. Mayfair has contracted a second assay laboratory to improve the turnaround time. Numerous assay results are pending and will be reported when received and compiled.

About Mayfair Gold

Mayfair is a Canadian mineral exploration company focused on advancing the 100% owned Fenn-Gib gold project in the Timmins region of Northern Ontario. The Fenn-Gib gold deposit is Mayfair’s flagship asset. An updated open-pit constrained NI 43-101 resource estimate (February 5, 2021) reported a total Indicated Resource of 70.2M tonnes containing 2.08M ounces at a grade of 0.921 g/t Au and an Inferred Resource of 3.8M tonnes containing 75,000 ounces at a grade of 0.618 g/t Au. The deposit has a strike length of approx. 1.25km with widths ranging up to 300m. The gold mineralized zones remain open at depth and along strike to the east and west.

For further information contact:

Patrick Evans, President and CEO
Email: [email protected]
Phone: (416) 670-5114
Web: www.mayfairgold.ca

Qualified Person Statement

Mayfair Gold’s disclosure of technical and scientific information in this news release has been reviewed and approved by Howard Bird, P Geo., Vice President Exploration for the Company, who serves as a Qualified Person under the definition of National Instrument 43-101.

Forward Looking Statements

This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, “forward-looking statements“) that relate to Mayfair’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result”, “are expected to”, “expects”, “will continue”, “is anticipated”, “anticipates”, “believes”, “estimated”, “intends”, “plans”, “forecast”, “projection”, “strategy”, “objective” and “outlook”) are not historical facts and may be forward-looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.

Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Mayfair’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID-19 pandemic and other factors. Mayfair undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Mayfair to predict all of them, or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

 Eugene A. Scherbakov, COO, to become CEO

Valentin P. Gapontsev, CEO, to transition to Executive Chairman of the Board and remain active

OXFORD, Mass., May 04, 2021 (GLOBE NEWSWIRE) — IPG Photonics Corporation (NASDAQ: IPGP) today announced a management change, which is effective immediately.

Eugene A. Scherbakov Ph.D., currently Chief Operating Officer, Managing Director of IPG Laser GmbH, Senior Vice President, Europe and Director, succeeds Valentin P. Gapontsev, Ph.D., as IPG Photonics’ Chief Executive Officer. Dr. Valentin Gapontsev, founder of the Company and current CEO and Chairman of the Board, becomes Executive Chairman and continues his involvement in directing research and development and strategy.

“Dr. Scherbakov’s technological knowledge as well as extensive understanding of the Company’s operations, sales and customers contributed significantly to IPG’s success since he joined us in 1995,” said Dr. Valentin Gapontsev. “Dr. Scherbakov’s leadership at our German operations and expertise resulted in operational excellence and lower production costs for our vertical integration model, making fiber laser technology more cost competitive with traditional materials processing technologies, while preserving IPG’s strong profitability and industry-leading margins.” Dr. Gapontsev continued, “The technology and product opportunities for IPG are enormous and I look forward to spending more time on our technical strategy. It’s an exciting evolution for me and a very good transition for the Company.”

“I feel extremely privileged to become the next CEO of this great company,” said Dr. Scherbakov. “I look forward to continuing the strategy of Dr. Gapontsev and building on the strong foundation he set in place. We are lucky that he will continue as Executive Chairman.”

“It is hard to overstate Dr. Gapontsev’s contribution to fiber lasers and IPG, as an inventor, entrepreneur and visionary,” said John Peeler, Lead Independent Director. “This implements the succession plan discussed by the IPG Board for some time. Dr. Scherbakov is uniquely qualified for his new role.”

Dr. Scherbakov has served as Managing Director of IPG Laser GmbH, IPG’s German subsidiary, since August 2000, Senior Vice President-Europe since February 2013 and Chief Operating Officer since February 2017. He has been a member of its Board of Directors since 2000.

About IPG Photonics Corporation

IPG Photonics Corporation is the leader in high-power fiber lasers and amplifiers used primarily in materials processing and other diverse applications. The Company’s mission is to make its fiber laser technology the tool of choice in mass production. IPG accomplishes this mission by delivering superior performance, reliability and usability at a lower total cost of ownership compared with other types of lasers and non-laser tools, allowing end users to increase productivity and decrease costs. A member of the S&P 500® Index, IPG is headquartered in Oxford, Massachusetts and has more than 30 facilities worldwide. For more information, visit www.ipgphotonics.com.

Contact

Eugene Fedotoff
Director of Investor Relations
IPG Photonics Corporation
508-597-4713
[email protected]

VANCOUVER, British Columbia, May 04, 2021 (GLOBE NEWSWIRE) — Standard Uranium Ltd. (“Standard Uranium” or the “Company”) (TSX-V: STND) (OTCQB: STTDF) (Frankfurt: FWB:9SU) is pleased to provide an update on its plans for the upcoming phase II summer drilling program at its flagship 25,886-hectare Davidson River Uranium Project (the “Project”). The Company concluded the Phase II winter program at the Project on March 29, 2021. Based on positive indications from the winter drill program, the Company announced on March 29, 2021 it would quadruple the summer program to 10,000 metres. Full details of the news release can be found on our website.

The Company is pleased to announce that Geotech Drilling has been selected as our new drilling partner at the Project. Along with Dahrouge Geological Ltd., Access Helicopters, and the team at Big Bear Lodge, all vendors have been secured and the phase II 10,000 metre summer drill program is slated to commence the first week of June with crews mobilizing the last week of May. The drill program is expected to run the entire summer season, wrapping up in mid-September.

The Project is situated in the Southwest Athabasca Uranium District of Saskatchewan, 25 to 30 kilometres to the west of Fission Uranium’s Triple R and NexGen’s Arrow deposits and encapsulates the inferred continuation of the uranium-fertile Patterson Lake corridor.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/316d1ee2-91d7-4623-a0d0-8950f9356c1e

Jon Bey, President and CEO comments: “I am very pleased with what we have accomplished at our Davidson River Project. We have a clear vision of where we need to be drilling this summer and have the required permits, community support, and vendors in place to execute. This will be an exceptionally busy summer for exploration companies in all sectors and we are proud to have secured exceptional vendor partners to drive our 10,000 m drill program. The outlook for uranium is bright as more countries move forward to meet their climate change goals with nuclear energy playing a significant role. We are proud to be a part of the clean energy future through the exploration and discovery of high-grade, basement-hosted uranium at Davidson River.”

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7a010b02-7da3-4107-a16d-a3c48b80d761

The Company plans to use the Big Bear Lodge located on Grygar Lake as its base camp for the upcoming summer exploration program. The Company has been collaborating with Big Bear Lodge for our last two drilling campaigns and have established a great working relationship with the local community. Chief Teddy Clark of the Clearwater River Dene Nation (the “CRDN”) has been supportive of our work programs due to the Company’s practice of working closely with local service providers and staff, whenever possible. Support has also been fostered with the commitment to the safety of the local community by exceeding health guidelines relating to Covid-19 management.

Sean Hillacre, Project Geologist, commented: “It has been an absolute pleasure working with the CRDN personnel at Big Bear Lodge and we look forward to continuing to grow our strong relationship with local contractors in northern Saskatchewan. It is important for us to partner with local communities and make use of the skills, experience, and talent they bring to our project. In addition, my personal experience with Dahrouge Geological Consulting Ltd. and Access Helicopters has been outstanding, and I am excited to work closely with them and the Geotech Drilling team to make this summer season the most successful yet.”

Next Exploration Steps at the Project:

• The Saint trend has provided promising geological results with only one drill hole thus far. The Company intends to drill this trend first with multiple holes to start the summer program.
• Assay results from the 2021 winter drill program are expected to arrive in mid-May and the Company will incorporate those results into planning the follow up drill holes on the Warrior trend.
• The southeastern portion of the Warrior trend is expected to be tested where several structural targets lie.
• The Company will progress to the next exploration milestone of widening the search to the other exploration corridors on the Project. The Bronco and Thunderbird trends have several targets of interest that were developed during the geophysical surveying of the Project.

Neil McCallum, VP Exploration of Standard Uranium, states: “With only twenty holes drilled to date on the Project, there are still numerous high priority targets that have yet to be tested. The progression of our exploration to the other exploration trends is an exciting milestone for the project. The targets on all of the trends have me very excited, and I look forward to sharing the results as we make progress.”

All scientific and technical information in this news release has been prepared by, or approved by Neil McCallum, VP Exploration of the Company. Mr. McCallum is a qualified person for the purposes of National Instrument 43-101 – Standards of Disclosure for Mineral Projects.

About Standard Uranium

We find the fuel to power a


clean energy


future.

Standard Uranium is a mineral resource exploration company based in Vancouver, British Columbia. Since its establishment, Standard Uranium has focused on the identification and development of prospective exploration stage uranium projects in the Athabasca Basin in Saskatchewan, Canada. Standard Uranium’s Davidson River Project, in the southwest part of the Athabasca Basin, Saskatchewan, is comprised of 21 mineral claims over 25,886 hectares. The Davidson River Project is highly prospective for basement hosted uranium deposits yet remains relatively untested by drilling despite its location along trend from recent high-grade uranium discoveries. A copy of the 43-101 Technical Report that summarizes the exploration on the Project is available for review under Standard Uranium’s SEDAR issuer profile (www.sedar.com).

For further information contact:

Jon Bey, President, Chief Executive Officer, and Chairman
550 Denman Street, Suite 200
Vancouver, BC V6G 3H1
Tel: 1 (306) 850-6699
E-mail: [email protected]

Cautionary Statement Regarding Forward-Looking Statements

This news release includes certain information and statements about management’s view of future events, expectations, plans and prospects that constitute “forward looking statements”, which are not composed of historical facts. Forward-looking statements may be identified by such terms as “believes”, “anticipates”, “intends”, “expects”, “estimates”, “may”, “could”, “would”, “will”, or “plan”, and similar expressions. Specifically, forward looking statements in this news release include, without limitation, statements regarding: the timing and content of upcoming work programs; timing of geochemical results; timing of drilling results; geological and drilling interpretations; and estimates of market conditions. These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results or events, performance, or achievements of the Company to differ materially from those anticipated or implied in such forward-looking statements. The Company believes that the expectations reflected in these forward-looking statements are reasonable, but there can be no assurance that actual results will meet management’s expectations. In formulating the forward-looking statements contained herein, management has assumed that business and economic conditions affecting the Company will continue substantially in the ordinary course and will be favourable to the Company. Factors that may cause actual results to differ materially from those anticipated by these forward looking statements include: the ability to commence and complete work on the Davidson River Project given the global COVID-19 pandemic; changes in equity markets; the Company’s ability to raise additional capital if and when necessary; and other factors as described in detail in the Company’s annual information form dated September 28, 2020 and other public filings, all of which may be viewed on SEDAR (www.sedar.com). Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.

Neither TSX-V nor its Regulation Services Provider (as that term is defined in the policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.

SAN DIEGO, May 04, 2021 (GLOBE NEWSWIRE) — NP Digital has been recognized for accomplishments achieved in B2B PPC campaigns with a 2021 Drum Award for Search on behalf of its client, Contentful, the leading content platform for digital-first business. The campaign was successful in delivering a 600 percent ROAS amidst a fluctuating search landscape and changing buying trends caused by the COVID-19 pandemic. NP Digital’s recognition highlights its innovative approach to paid search and SEO, and its dedication to supporting initiatives that drive impact for its clients and their business goals.

“We are extremely proud of our work we have been able to fulfill for our clients and the incredible results we have produced,” said Mike Gullaksen, CEO of NP Digital. “We are constantly grateful to have the opportunity to support and accelerate our clients’ businesses, and especially given the unique circumstances in the last year, this award provides extra value and recognition to our team’s dedication and resilience.”

NP Digital’s PPC campaign was launched to support Contentful’s scaling global demand generation efforts as they approached their Series E funding round. With aggressive lead targets and pipeline goals, NP Digital’s paid search and SEO teams collaborated to deploy a full funnel paid search strategy that would mirror internal Contentful efforts for cohesiveness.

Through the elaborate and strategic work over the course of 2020, paid search was able to exceed all other paid channels in pipeline contribution, generating more than double the ROAS and 10 times the pipeline contribution from PPC in 2019. NP Digital’s results have allowed Contentful to scale budgets every quarter post-COVID, setting the brand up for further success in the future.

About NP Digital

NP Digital is a marketing agency built and run by marketers, not bankers. That independence sets us apart and allows us to serve our clients with speed, efficiency and creativity. Applying a holistic vision with specialist execution, the NP Digital team is driven to deliver the right content in the right context at scale. Our expertise in organic search optimization, content marketing, paid search, programmatic advertising, social media marketing, strategy, and data and analytics has led to valuable, lasting partnerships with some of the world’s most important brands. Learn more about NP Digital at npdigital.com.

About Contentful

Contentful, the leading content platform for digital-first business, helps over 30% of the Fortune 500 and thousands of brands around the world create and manage digital experiences for their customers across any channel. It enables greater speed and scale than traditional CMS solutions. Contentful unifies content in a single hub, structures it for use in any digital channel, and integrates seamlessly with hundreds of other tools through open APIs. Companies such as Chanel, Bang & Olufsen, Shiseido, Peloton, BP and many others rely on Contentful’s platform. For more information, visit https://www.contentful.com/.

About The Drum Awards for Search

The Drum Awards for Search recognize creative thinking, strategy, and technological innovation – setting the standard for best practice across both organic and paid. In 2021, The Drum Awards for Search celebrated its picks of the most cutting-edge digital agencies and its exceptional campaigns.

###

EAGLE, Idaho, May 04, 2021 (GLOBE NEWSWIRE) — The Pennant Group, Inc. (NASDAQ: PNTG), the parent company of operating subsidiaries that provide home health, hospice and senior living services, announced today that it expects to issue its first quarter 2021 financial results on Thursday, May 6, 2021.

Pennant invites current and prospective investors to tune into a live webcast to be held the following day, Friday, May 7, 2021 at 10:00 a.m. Mountain Time (12:00 p.m. Eastern Time), during which Pennant’s management will discuss its first quarter 2021 results.

To listen to the webcast, or to view any financial or other statistical information required by SEC Regulation G, please visit the Investor Relations section of our website at http://investor.pennantgroup.com. The webcast will be recorded and will be available for replay via the website until 5:00 p.m. Mountain Time on Friday, June 4, 2021.

About Pennant

The Pennant Group, Inc. is a holding company of independent operating subsidiaries that provide healthcare services through 85 home health and hospice agencies and 54 senior living communities located throughout Arizona, California, Colorado, Idaho, Iowa, Montana, Nevada, Oklahoma, Oregon, Texas, Utah, Washington, Wisconsin and Wyoming. Each of these businesses is operated by a separate, independent operating subsidiary that has its own management, employees and assets. References herein to the consolidated “company” and “its” assets and activities, as well as the use of the terms “we,” “us,” “its” and similar verbiage, are not meant to imply that The Pennant Group, Inc. has direct operating assets, employees or revenue, or that any of the home health and hospice businesses, senior living communities or the Service Center are operated by the same entity. More information about Pennant is available at http://www.pennantgroup.com.

Contact


  

The Pennant Group, Inc.
(208) 506-6100
[email protected]

SOURCE: The Pennant Group, Inc.

– Highest dose cohorts confirm and extend previously-reported 3 mg/kg IV cohort data –

– 10 mg/kg IV dose provides full receptor occupancy through Day 71 and complete suppression of TDAR after KLH challenge and re-challenge through at least Day 57 –

– 5 mg/kg SC dose provides full receptor occupancy through Day 43 and complete suppression of TDAR after KLH challenge through at least Day 29 –

– Plan to initiate Phase 2 proof-of-concept trial in patients in 2H 2021 –

HAMILTON, Bermuda, May 04, 2021 (GLOBE NEWSWIRE) — Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, today announced positive final data from the Phase 1 clinical trial of KPL-404 in healthy volunteers. KPL-404 is a monoclonal antibody designed to inhibit interaction of CD40 with CD154 (CD40 ligand), a well-known pathway that plays a critical role in regulating B cell proliferation, T cell activation, and antibody production.

“The final KPL-404 Phase 1 data are very encouraging, as they confirm and extend the findings from the previously-reported lower-dose cohorts,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “The data reinforce our confidence in KPL-404 as a potential best-in-class treatment option and support the optionality for studying chronic KPL-404 dosing in patients with subcutaneous and/or intravenous administration. To this end, we plan to evaluate KPL-404 in a Phase 2 proof of concept study in rheumatoid arthritis patients. We believe that a study in this patient population will be translatable to a spectrum of other devastating autoimmune diseases with high unmet need.”

The Phase 1 trial of KPL-404 was a randomized, double-blind, placebo-controlled, single-ascending-dose, first-in-human study in healthy volunteers that was divided into two parts: a single dose of KPL-404 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg administered intravenously (IV) and a single dose of KPL-404 1 mg/kg or 5 mg/kg administered subcutaneously (SC). The primary objective was to assess the safety and tolerability of KPL-404. Secondary endpoints included pharmacokinetics, the immune response, T-cell Dependent Antibody Response (TDAR) to the novel test antigen keyhole limpet hemocyanin (KLH) in clinically-relevant dose level cohorts, and the anti-drug antibody response. CD40 receptor occupancy (RO) was an exploratory endpoint.

KPL-404 showed dose-dependent increases in concentration across cohorts. All dose escalations occurred as per protocol with no dose-limiting safety findings. KPL-404 was well-tolerated, and there were no serious adverse events. Subjects dosed with KPL-404 10 mg/kg IV showed full RO through at least Day 71 and complete suppression of TDAR after KLH challenge and re-challenge through at least Day 57. Subjects dosed with KPL-404 5 mg/kg SC showed full RO through Day 43 and suppression of TDAR after KLH challenge through at least Day 29. These data confirm and extend previously-reported 3 mg/kg IV cohort data, in which RO and suppression of TDAR after KLH challenge were demonstrated through Day 29. The 3 mg/kg IV dose level had previously demonstrated complete suppression of memory TDAR response to a re-challenge on Day 29. Anti-drug antibodies to KPL-404 were suppressed for at least 57 days at 10 mg/kg IV; the suppression of antibody responses to the drug itself is an independent indicator of target engagement and pharmacodynamic effect.

“Dysregulation of the CD40-CD154 pathway has been implicated in the pathophysiology of multiple autoimmune diseases, and the totality of the Phase 1 data underscore the magnitude and duration of memory immune response suppression by KPL-404,” said John F. Paolini, MD, PhD, Chief Medical Officer of Kiniksa. “The 10 mg/kg intravenous cohort data demonstrate the full power of KPL-404, and 5 mg/kg subcutaneous cohort data demonstrate practical utility for potential convenient chronic dosing in patients.”

Kiniksa plans to initiate a Phase 2 proof-of-concept trial in rheumatoid arthritis in the second half of 2021. The trial will evaluate safety and pharmacokinetics of KPL-404 with subcutaneous administration over 12 weeks. Rheumatoid arthritis was selected as a well-characterized autoimmune disease with decades of published clinical data across diverse mechanistic classes, allowing for objective evaluation in established endpoints. The pharmacokinetic lead-in of the planned trial supports characterization of chronic administration of KPL-404 in a patient population and provides optionality to evaluate the therapeutic potential of KPL-404 across a range of other autoimmune diseases with pathologies believed to be mediated by the CD40-CD154 pathway.

About KPL-404

KPL-404 is an investigational humanized monoclonal antibody that is designed to inhibit CD40-CD154 (CD40 ligand) interaction, a key T-cell co-stimulatory signal critical for B-cell maturation and immunoglobulin class switching and Type 1 immune responses. Kiniksa believes disrupting the CD40-CD154 interaction is an attractive approach for multiple autoimmune disease pathologies such as rheumatoid arthritis, Sjogren’s syndrome, Graves’ disease, systemic lupus erythematosus and solid organ transplant. Kiniksa owns or controls the intellectual property related to KPL-404.

About KPL-404 Phase 1 Trial

The Phase 1 trial of KPL-404 is a randomized, double-blind, placebo-controlled, single-ascending-dose, first-in-human study that is divided into two parts: a single dose of KPL-404 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg intravenously (IV) and a single dose of KPL-404 1 mg/kg or 5 mg/kg subcutaneously (SC). The primary objective is to assess the safety and tolerability of KPL-404. Secondary endpoints include pharmacokinetics, the immune response to the novel test antigen keyhole limpet hemocyanin (KLH) in clinically relevant dose cohorts, and the anti-drug antibody response. CD40 receptor occupancy (RO) was an exploratory endpoint.

About Kiniksa

Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s portfolio of assets, ARCALYST^®, mavrilimumab, vixarelimab and KPL-404, are based on strong biologic rationale or validated mechanisms, target underserved conditions and offer the potential for differentiation. These assets are designed to modulate immunological pathways across a spectrum of diseases. For more information, please visit www.kiniksa.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our beliefs about the final data from the Phase 1 clinical trial of KPL-404 in healthy volunteers and its potential, including its potential to be a best-in-class treatment option; our beliefs about what the totality of the Phase 1 data show and support, including the optionality of dosing administrations in patients; expected timing for initiating a Phase 2 proof-of-concept trial of KPL-404 in in rheumatoid arthritis patients; our rationale for selecting rheumatoid arthritis for the trial patient population, including our belief that a study in that patient population being translatable to a spectrum of other devastating autoimmune diseases with high unmet need; our planned trial design; our beliefs about the mechanisms of action of our product candidates and potential impact of their approach, including our belief that KPL-404’s disruption of the CD40-CD154 interaction is an attractive approach for multiple autoimmune disease pathologies; and our belief that all of our product candidates offer the potential for differentiation.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in initiating, enrolling and completing our Phase 2 proof-of-concept clinical trial of KPL-404 in patients with rheumatoid arthritis; our potential inability to replicate in later clinical trials the positive final data from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by KPL-404; our reliance on third parties to manufacture our product candidates; drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates, including for KPL-404; potential complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials, including for the Phase 2 clinical trial; the potential impact of the COVID-19 pandemic and measures taken in response to the pandemic on our business and operations as well as the business and operations of our manufacturers, CROs upon whom we rely to conduct our clinical trials, and other third parties with whom we conduct business or otherwise engage, including the FDA and other regulatory authorities; changes in our operating plan and funding requirements; and existing or new competition.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 25, 2021 and our other reports subsequently filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

ARCALYST^® is a registered trademark of Regeneron Pharmaceuticals, Inc.

Every Second Counts!™

Kiniksa Investor and Media Contact

Mark Ragosa
(781) 430-8289
[email protected]