Market Newsdesk

KIRKLAND, Wash., Dec. 15, 2020 (GLOBE NEWSWIRE) — Monolithic Power Systems, Inc. (MPS) (Nasdaq: MPWR), a leading company in high-performance analog solutions, today announced its fourth quarter dividend of $0.50 per common share to all stockholders of record as of the close of business on December 31, 2020. The dividend will be paid to stockholders on January 15, 2021.

Safe Harbor Statement

This news release includes “forward-looking statements” intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on our current expectations, estimates and projections about our business and industry, management’s beliefs, and certain assumptions made by us, all of which are subject to change. Forward-looking statements can often be identified by words such as “anticipates,” “expects,” “forecasts,” “intends,” “believes,” “plans,” “may,” “will,” or “continue,” and similar expressions and variations or negatives of these words. All such statements are subject to certain risks, assumptions and uncertainties, including those described in our most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other documents that we file or furnish with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially and adversely from those projected, and may affect our future operating results, financial position and cash flows. Accordingly, you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Except to the extent required by law, MPS does not undertake, and expressly disclaims, any duty or obligation to update publicly any forward-looking statement after the initial distribution of this release, whether as a result of new information, future events, changes in assumptions or otherwise.

About Monolithic Power Systems, Inc.

Monolithic Power Systems, Inc. (MPS) provides small, highly energy efficient, easy-to-use power solutions for systems found in industrial applications, telecom infrastructures, cloud computing, automotive, and consumer applications. MPS’ mission is to reduce total energy consumption in its customers’ systems with green, practical, compact solutions. The company was founded by Michael Hsing in 1997 and is based in the United States. MPS can be contacted through its website at www.monolithicpower.com or its support offices around the world.

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Monolithic Power Systems, MPS, and the MPS logo are registered trademarks of Monolithic Power Systems, Inc. in the U.S. and trademarked in certain other countries.

Contact:
Bernie Blegen
Chief Financial Officer
Monolithic Power Systems, Inc.
408-826-0777
[email protected]

–  Generally well-tolerated with a favorable safety profile in five patients

–  Serum beta-galactosidase enzyme activity increased in all patients at all timepoints between Day 7 and Month 6, representing an approximate doubling in enzyme activity after gene transfer

–  At Month 6, enzyme activity restored to 23-57% (mean: 38%) of normal reference levels

–  All five children demonstrated signs of clinical disease stability as assessed by Vineland-3 Growth Scale Value, Upright and Floor Mobility, and Clinical Global Impression (CGI) scales

–  High-dose cohort initiated in November 2020; two patients now dosed without complications

NEW YORK and RESEARCH TRIANGLE PARK, N.C., Dec. 15, 2020 (GLOBE NEWSWIRE) — Sio Gene Therapies Inc. (NASDAQ: SIOX), a clinical-stage company focused on developing gene therapies to radically improve the lives of patients with neurodegenerative diseases, today reported positive six-month follow-up data from the low-dose cohort (1.5×10¹³ vg/kg) of the Company’s dose escalation study of AXO-AAV-GM1, its adeno-associated viral vector (AAV)9-based gene therapy candidate for the treatment of GM1 gangliosidosis. Initial data from the ongoing Phase 1/2 study in five patients in the low-dose cohort showed that AXO-AAV-GM1 was generally well tolerated with a favorable safety profile and provide early indications of clinical disease stability.

“We are excited to report encouraging safety, tolerability, biomarker, and preliminary efficacy data for AXO-AAV-GM1, the first gene therapy evaluated in a clinical trial for GM1 gangliosidosis, a life-limiting disease caused by mutations in the GLB1 gene that impair beta-galactosidase enzyme activity. Safety was the key measure in this first-in-human study, and we are pleased to see a favorable safety profile in the first five children treated with the low-dose,” said Gavin Corcoran, M.D., Chief R&D Officer of Sio Gene Therapies. “At this early timepoint post-treatment, we observed an increase in beta-galactosidase enzymatic activity, reaching on average 38% of normal reference levels. This is encouraging given that evidence in the medical literature for lysosomal storage diseases suggests that increases in enzyme activity, to between 10-20% of normal levels, can lead to clearance of stored lysosomal substrates and may be associated with slower disease progression. We are also encouraged by consistent signs of disease stabilization across multiple measures of neurodevelopment in all five children at six months as compared to the predictable decline observed in natural history studies. These data highlight the potential for the investigational gene therapy to treat the underlying genetic cause of this disease, preserve functional outcomes, and reduce disease burden for patients and their families. Further, the safety profile observed in the low-dose cohort support moving forward with the high-dose cohort of AXO-AAV-GM1 in the ongoing Phase 1/2 study. We look forward to presenting program updates at future medical conferences.”

Dr. Cynthia Tifft, Deputy Clinical Director of the National Human Genome Research Institute (NHGRI) added, “I have been studying and caring for children with GM1 gangliosidosis for more than 10 years, and I have seen the impact of this relentlessly progressive, uniformly fatal disease on the children and the heavy physical and psychological burden on families and caregivers. With no approved therapies, the treatment options today are limited to aggressive supportive care with physical, occupational and speech therapy and later with feeding tubes and anti-convulsants to minimize seizures. I am encouraged by the results-to-date where we have seen preservation of function and in a few measures even improvement. As we advance to the high-dose cohort, I am also pleased that the side effects of the treatment have been minimal and easily managed.”

Six-Month Follow-Up Results

Baseline Characteristics:

• Total of 5 Type II patients evaluated: 4 late-infantile onset patients (aged 32-68 months at time of dosing), and 1 juvenile onset patient (aged 45 months at time of dosing).
• All patients had documented biallelic mutations in GLB1 gene, deficiency of beta-galactosidase enzyme activity, and clinical phenotype consistent with GM1 gangliosidosis.
• All 5 patients exhibited impairment of fine motor skills and change in walking pattern on clinical history at baseline.

Safety and Tolerability:

• AXO-AAV-GM1 was generally well-tolerated with a favorable safety profile at the low dose (1.5×10¹³ vg/kg) delivered intravenously.
• There have been no serious adverse events (SAEs) related to gene therapy.
  • One SAE was described: a single patient experienced bacterial sepsis due to a PICC line infection, which was considered to be unrelated to the investigational drug product, and which resolved within a few days following line removal and administration of IV antibiotics.
• The most common adverse events were considered mild to moderate. Transient AST elevations were observed in 4 subjects, none of which required clinical intervention or had associated clinical sequelae. There were no other adverse events indicative of impaired liver function including serum bilirubin, GGT, and ALT. No clinically relevant changes were observed in platelet count.
• The favorable safety profile in the low-dose cohort supports continued enrollment of patients in the high-dose cohort (4.5×10¹³ vg/kg), in which two patients have now been dosed without complications.

Biomarkers:

• Serum beta-galactosidase enzyme activity was sampled at nine distinct timepoints between Day 7 and Month 6, and increased from baseline between 71-138% (mean: 110%) during the 6-month observation period, representing an approximate doubling in enzyme activity after gene transfer. At Month 6, serum enzyme activity increased by an average of 71% from baseline (range: 33%-127%) across the five patients.
• On average, serum enzyme activity was restored to 38% of normal reference levels at Month 6, with individual patients ranging from 23-57% of normal reference levels. The reference level was defined by the lowest level of enzyme activity in serum from 30 healthy adult volunteers using the same validated assay of beta-galactosidase enzyme activity as was used to assess the patients in the study.
• Cerebrospinal fluid (CSF) samples were collected from all patients through lumbar puncture. Development and validation of biomarker assays for CSF is currently ongoing.

Clinical and Functional Outcomes:

• Patients were assessed by multiple measures of neurodevelopment including the Vineland Adaptive Behavior Scales 3^rd Edition (VABS-3), Upright and Floor Mobility Score, and Clinical Global Impression (CGI).
  • VABS-3 is a standardized measure of adaptive behavior that is widely used to evaluate communication, daily living, social skills, and motor function. VABS-3 scores have a predictable relationship to ability, allowing for comparative assessments with increasing age.
  • Predictable functional decline in abilities has been well documented in natural history studies, showing an age-related statistically significant decline in all sub-domains of the VABS-3 scale and in Floor and Upright Mobility Scores.
• All five patients demonstrated disease stability at 6 months post-treatment as assessed by VABS-3 Growth Scale Value scores, Upright and Floor Mobility Score, and CGI relative to baseline values.
• Subdomain Growth Scale Value scores in the VABS-3 remained stable or improved in four out of five patients.
• Floor Mobility Scores were scored at the highest level based on age in all five patients, indicating the ability to crawl in 4-points independently, and remained stable at all timepoints evaluated over the six-month observation period.
• Upright Mobility Scores were stable in all five patients, with function maintained at all timepoints evaluated over the 6-month observation period.
• Clinical Global Impression (CGI), a clinician’s assessment of change in disease severity from baseline, mildly improved in four out of five patients and remained stable in the fifth patient over the six-month evaluation period.
• Additional data will be collected at the 12-month evaluation including several measures of the systemic manifestations of GM1 gangliosidosis.

The Phase 1/2 study (NCT03952637) is designed to evaluate the safety, tolerability, and potential efficacy of AXO-AAV-GM1 delivered intravenously in children with Type I and Type II GM1 gangliosidosis. In Stage 1 of the study, the low-dose cohort is evaluating 1.5×10¹³ vg/kg AXO-AAV-GM1 gene therapy in a total of five Type II (late-infantile and juvenile) patients, and the ongoing high-dose cohort is evaluating a dose of 4.5×10¹³ vg/kg AXO-AAV-GM1 gene therapy in both Type I (early infantile) and Type II children.

About AXO-AAV-GM1

AXO-AAV-GM1 delivers a functional copy of the GLB1 gene via an adeno-associated viral (AAV) vector, with the goal of restoring β-galactosidase enzyme activity for the treatment of GM1 gangliosidosis. The gene therapy is delivered intravenously, which has the potential to broadly transduce the central nervous system and treat peripheral manifestations of the disease as well. Preclinical studies in murine and a naturally-occurring feline model of GM1 gangliosidosis have supported AXO-AAV-GM1’s ability to improve β-galactosidase enzyme activity, reduce GM1 ganglioside accumulation, improve neuromuscular function, and extend survival.

AXO-AAV-GM1 has received both Orphan Drug Designation and Rare Pediatric Disease Designation from the Food and Drug Administration and is the only gene therapy in clinical development for both Type I and Type II GM1 gangliosidosis.

In 2018, Sio licensed exclusive worldwide rights from the University of Massachusetts Medical School for the development and commercialization of gene therapy programs for GM1 gangliosidosis and GM2 gangliosidosis, including Tay-Sachs and Sandhoff diseases.

About Sio Gene Therapies

Sio Gene Therapies combines cutting-edge science with bold imagination to develop genetic medicines that aim to radically improve the lives of patients. Our current pipeline of clinical-stage candidates includes the first potentially curative AAV-based gene therapies for GM1 gangliosidosis and Tay-Sachs/Sandhoff diseases, which are rare and uniformly fatal pediatric conditions caused by single gene deficiencies. We are also expanding the reach of gene therapy to highly prevalent conditions such as Parkinson’s disease, which affects millions of patients globally. Led by an experienced team of gene therapy development experts, and supported by collaborations with premier academic, industry and patient advocacy organizations, Sio is focused on accelerating its candidates through clinical trials to liberate patients with debilitating diseases through the transformational power of gene therapies. For more information, visit www.siogtx.com.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “will,” “expect,” “believe,” “estimate,” and other similar expressions are intended to identify forward-looking statements. For example, all statements Sio makes regarding costs associated with its operating activities are forward-looking. All forward-looking statements are based on estimates and assumptions by Sio’s management that, although Sio believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Sio expected. Such risks and uncertainties include, among others, the impact of the Covid-19 pandemic on our operations, the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the development of a suspension-based manufacturing process for AXO-Lenti-PD; the scaling up of manufacturing, the expectations for regulatory submissions and approvals; the continued development of our gene therapy product candidates and platforms; Sio’s scientific approach and general development progress; and the availability or commercial potential of Sio’s product candidates. These statements are also subject to a number of material risks and uncertainties that are described in Sio’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 13, 2020, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Sio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts:

Media

Josephine Belluardo, Ph.D.
LifeSci Communications
(646) 751-4361
[email protected]
info@siogtx.com

Investors and Analysts

David Nassif
Sio Gene Therapies Inc.
Chief Financial Officer and General Counsel
(646) 677-6770
[email protected]

ST. LOUIS, Dec. 15, 2020 (GLOBE NEWSWIRE) — Amdocs (NASDAQ: DOX), a leading provider of software and services to communications and media companies, has filed its Annual Report on Form 20-F for the fiscal year ended September 30, 2020 (including its financial statements for such year) with the U.S. Securities and Exchange Commission. The annual report is available through the Company’s website (http://www.amdocs.com/media-room/annual-report-2020). Upon the request of a shareholder of the Company, the Company will promptly provide to such shareholder a copy of the 2020 annual report, free of charge.

About Amdocs

Amdocs’ purpose is to enrich lives and progress society, using creativity and technology to build a better connected world. Amdocs and its 26,000 employees partner with the leading players in the communications and media industry, enabling next-generation experiences in 85 countries. Our cloud-native, open and dynamic portfolio of digital solutions, platforms and services brings greater choice, faster time to market and flexibility, to better meet the evolving needs of our customers as they drive growth, transform and take their business to the cloud. Listed on the NASDAQ Global Select Market, Amdocs had revenue of $4.2 billion in fiscal 2020.

For more information, visit Amdocs at www.amdocs.com.

Contact:

Matthew Smith
Head of Investor Relations
Amdocs
Tel: +1 (314) 212-8328
E-mail: [email protected] 

CALGARY, Alberta, Dec. 15, 2020 (GLOBE NEWSWIRE) — (PIPE – TSX-V) Pipestone Energy Corp. (“Pipestone” or the “Company”) is pleased to announce that its common shares and warrants have been approved for listing on the Toronto Stock Exchange (“TSX”) and will commence trading on the TSX at the opening of the market on December 16, 2020. Concurrent with the up-listing to the TSX, the common shares and warrants of Pipestone will be de-listed from the TSX Venture Exchange. Pipestone’s ticker symbol for the common shares and warrants will remain “PIPE” and “PIPE.WT”, respectively.

The Company’s graduation to the TSX marks an important milestone for the business and coincides with Pipestone’s operational and financial execution to date, as well as its three-year corporate growth plan.

Pipestone Energy Corp.

Pipestone Energy Corp. is an oil and gas exploration and production company with its head office located in Calgary, Alberta. The company is focused on developing its pure-play condensate-rich Montney asset in the Pipestone area near Grande Prairie. Pipestone is committed to building long term value for our shareholders and values the partnerships that it is developing within its operating community. For more information, visit www.pipestonecorp.com.

Pipestone Contacts:

Paul Wanklyn President and Chief Executive Officer (587) 392-8407 [email protected]	Craig Nieboer Chief Financial Officer (587) 392-8408 [email protected]
Dan van Kessel VP Corporate Development (587) 392-8414 [email protected]

Advisory Reg
arding Forward-Looking Statements

In the interest of providing shareholders of Pipestone and potential investors information regarding Pipestone, this news release contains certain information and statements (“forward-looking statements”) that constitute forward-looking information within the meaning of applicable Canadian securities laws.

In particular, but without limiting the foregoing, this news release contains forward-looking statements pertaining to: expected commencement of trading of Pipestone common shares and warrants on the TSX, and expected de-listing of common shares and warrants from the TSX Venture Exchange.

The forward-looking statements contained in this news release are made as of the date hereof and Pipestone assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by applicable securities laws. All forward-looking statements herein are expressly qualified by this advisory.

TSX Venture Exchange Disclaimer

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

FLORHAM PARK, N.J., Dec. 15, 2020 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that it intends to offer and sell, subject to market and other conditions, 2,250,000 shares of its common stock in an underwritten public offering. In addition, Phathom intends to grant the underwriters a 30-day option to purchase up to an additional 337,500 shares of common stock. All of the shares to be sold in the offering are to be sold by Phathom. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Phathom intends to use the net proceeds from the proposed offering to fund the clinical development of vonoprazan and for working capital and general corporate purposes, including pre-commercial activities.

Jefferies, Evercore ISI, Guggenheim Securities and BMO Capital Markets are acting as joint bookrunning managers for the offering. Needham & Company is acting as lead manager for the offering.

The securities described above are being offered by Phathom pursuant to a shelf registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; or from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200 or by email at [email protected]; or from Guggenheim Securities LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-5548 or by email at [email protected]; or from BMO Capital Markets Corp., 3 Times Square, 25th Floor, New York, NY 10036, Attention: Equity Syndicate Department, by telephone at (800) 414-3627, or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov.

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

About Phathom

Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders.

Forward-Looking Statements

Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements relating to the offering, including the timing and size of the offering and the anticipated use of proceeds therefrom and the grant of the option to purchase additional shares. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering, the risks and uncertainties inherent in Phathom’s business, including potential delays in the commencement, enrollment and completion of clinical trials; Phathom’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; and unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; and the other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

CONTACTS

Media Contact:

Nick Benedetto
1-877-742-8466
[email protected]

Investor Contact:

Todd Branning
1-877-742-8466
[email protected]

 

CytoDyn is simultaneously finalizing an EUA application with the Philippine FDA with patient data from CD10 and recent eINDs for severe-to-critical patients

VANCOUVER, Washington, Dec. 15, 2020 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it had reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter.

On October 20, 2020, following review and recommendation by the Data Safety Monitoring Committee (DSMC) of data from 195 patients, the Company continued the trial without modification to achieve the primary endpoint. The DSMC also requested a second review of the data after 75% (or 293) of the patients were enrolled and completed a 42-day post-enrollment period. The Company has concluded it will be far more time efficient to forego the second interim analysis and to analyze the data on 390 patients and to provide final data to the U.S. Food and Drug Administration, Health Canada, U.K.’s MHRA, and Philippines FDA, as soon as it is available.

CytoDyn’s Phase 2b/3 trial to evaluate the efficacy and safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very thankful for the concerted efforts by so many healthcare professionals to reach full enrollment so quickly in these trying times. To the best of our knowledge, we are the first company to complete a Phase 3 trial for COVID-19 severe-to-critical population. Currently, there are hundreds of thousands of patients around the globe with an immediate need for a safe and efficacious therapeutic to combat this horrific pandemic. Since the Philippine FDA has relaxed the criteria of EUA for any safe drug with any efficacy data, we will file our EUA as soon as the presidential order is implemented by the Philippine FDA with all of the information we currently have available, which we believe could occur within the next couple of weeks. The Company is working diligently to ensure a sufficient supply of drug product is available to meet the urgent needs of patients.”

About Coronavirus Disease 2019

CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.

About Leronlimab (PRO 140)

The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients). 

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use. 

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.  

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute
GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the Company is closing down its Phase 2 trial for acute GvHD. 

About CytoDyn

CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Company’s questions concerning its recent Biologics License Application (“BLA”) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.

CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com. 

Forward-Looking Statements 

This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict.  Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTS

Investors:

Michael Mulholland
Office: 360.980.8524, ext. 102
[email protected]

VANCOUVER, British Columbia, Dec. 15, 2020 (GLOBE NEWSWIRE) — Novo Resources Corp. (“Novo” or the “Company”) (TSX-V: NVO & NVO.WT; OTCQX: NSRPF) today announced details of the Company’s upcoming investor presentation to be held subsequent to the Company’s annual general meeting (the “Meeting”) on December 17, 2020. The presentation will begin at 4:30 p.m. PST and will be accessible through a live presentation link (details provided below).

Due to the ongoing health risk related to the COVID-19 pandemic and continuing government restrictions on public gatherings in support of social distancing, the Company strongly recommends that shareholders cast their votes by proxy in advance of the Meeting and not attend the Meeting in person.  Despite this, any registered shareholder wishing to attend the Meeting must contact Diane Barley at [email protected] in advance so that they may be informed of applicable safety protocols. Please see the Company’s notice of meeting and information circular, as filed under the Company’s profile at www.sedar.com, and on the Company’s website at www.novoresources.com, for further details of the Meeting.

Investor Presentation Details
Date:	Thursday, December 17 @ 4:30 p.m. PST
Link:	https://us02web.zoom.us/j/83292159735?pwd=Z1hZQ3FkeVNMZmJHQjNMYlJMT090QT09
Webinar ID*:	832 9215 9735
Passcode:	501078
Canadian dial-in:	+1 647 374 4685 / +1 647 558 0588 / +1 778 907 2071 / +1 204 272 7920 / +1 438 809 7799 / +1 587 328 1099
US dial-in:	+1 253 215 8782 / +1 669 900 6833 / +1 346 248 7799 / +1 301 715 8592 / +1 312 626 6799 / +1 929 205 6099
Australian dial-in:	+61 2 8015 6011 / +61 3 7018 2005 / +61 7 3185 3730 / +61 8 6119 3900 / +61 8 7150 1149
International dial-in:	https://us02web.zoom.us/zoomconference?m=hE0vYbeiW7uHWdDa6A-e-ntMhg81EIBN

*Please note that you may be required to download Zoom software prior to joining the presentation. Please allow sufficient time to do so.

Shareholders with any questions are encouraged to contact Leo Karabelas at [email protected] or +1-416-543-3120.

About Novo Resources Corp.

Novo is advancing its flagship Beatons Creek gold project to production while exploring and developing its highly prospective land package covering approximately 14,000 square kilometres in the Pilbara region of Western Australia. In addition to the Company’s primary focus, Novo seeks to leverage its internal geological expertise to deliver value-accretive opportunities to its shareholders. For more information, please contact Leo Karabelas at +1-416-543-3120 or e-mail [email protected]

On Behalf of the Board of Directors,

Novo Resources Corp.

“

Quinton Hennigh

”                        

Quinton Hennigh

Chairman and President

Neither 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.

DANBURY, Conn., Dec. 15, 2020 (GLOBE NEWSWIRE) — In 1986, Ethan Allen’s Chairman and CEO, Farooq Kathwari, invited every Ethan Allen interior designer to company headquarters in Danbury, Connecticut, for a multi-day celebration. This beloved tradition continued for 33 years and grew to include a slate of awards for exceptional interior design work.

When this year’s COVID-19 pandemic made a 34th gathering in Danbury all but impossible, Kathwari and his team orchestrated the company’s first-ever Virtual Celebration. The livestreamed event brought together over 4,000 Ethan Allen associates from all over the world, including designers, retailers, manufacturing, logistics, and headquarters, capping off a year of strong sales performance even in the midst of significant challenges.

The Virtual Celebration opened with a series of videos that chronicled the history of Ethan Allen and gave an overview of its current operations. The event also included livestreamed recognition of associates honored for decades of exemplary service, and awards for interior designers that recognized both exemplary sales performance and outstanding achievements in interior design. All award recipients received a signed copy of Mr. Kathwari’s memoir – Trailblazer: from the Mountains of Kashmir to the Summit of Global Business and Beyond.

“I’m proud of what our associates have accomplished during such a challenging year, and I’m pleased that we found the opportunity to highlight their achievements in a format that brought everyone in the Ethan Allen family together,” Kathwari commented. “Many offered feedback after the event, saying they felt it was our best celebration ever.”

ABOUT ETHAN ALLEN

Ethan Allen Interiors Inc. (NYSE: ETH) is a leading interior design company and manufacturer and retailer of quality home furnishings. The Company offers complimentary interior design service to its clients and sells a full range of furniture products and decorative accessories through ethanallen.com and a network of approximately 300 design centers in the U.S. and abroad. Ethan Allen owns and operates nine manufacturing facilities including six manufacturing plants in the U.S. plus two plants in Mexico and one in Honduras. Approximately 75% of its products are made in its North American plants. For more information on Ethan Allen’s products and services, visit www.ethanallen.com.

Contact:
Geri Moran
Vice President, Marketing & Public Relations
[email protected]
203-743-8374

London, UK, Dec. 15, 2020 (GLOBE NEWSWIRE) — EdtechX Holdings Acquisition Corp. II (Nasdaq: EDTXU) (the “Company”) announced today that it has consummated its initial public offering of 10,000,000 units at $10.00 per unit, generating gross proceeds of $100,000,000.

The Company’s units are listed on The Nasdaq Capital Market and commenced trading under the symbol “EDTXU” on December 11, 2020. Each unit consists of one share of the Company’s Class A common stock, $0.0001 par value per share (“Class A Common Stock”), and one-half of one redeemable warrant (“Warrant”) with each whole Warrant entitling the holder to purchase one share of Class A Common Stock at a price of $11.50 per share. Once the securities comprising the units begin separate trading, the Class A Common Stock and Warrants are expected to be traded on The Nasdaq Capital Market under the symbols “EDTX”, and “EDTXW”, respectively. No fractional warrants will be issued upon separation of the units and only whole warrants will trade.

The underwriters have been granted a 45-day option to purchase up to an additional 1,500,000 units offered by the Company to cover over-allotments, if any.

Jefferies LLC acted as the sole book-running manager of the offering and Macquarie Capital acted as the lead manager of the offering.

A registration statement relating to these securities has been declared effective by the U.S. Securities and Exchange Commission on December 10, 2020. The offering was made only by means of a prospectus, copies of which may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-821-7388 or by email at [email protected]. Copies of the registration statement can be accessed through the SEC’s website at www.sec.gov.

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

About EdtechX Holdings Acquisition Corp. II

EdtechX Holdings Acquisition Corp. II is a blank check company organized for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or other similar business combination with one or more businesses or entities. The Company’s efforts to identify a prospective target business will not be limited to any particular industry or geographic region, although the Company initially intends to focus on target businesses in the education, training, reskilling, human capital and education technology industries.  EdtechX Holdings Acquisition Corp. II is led by its founders, Charles McIntyre, Executive Chairman and Chief Investment Officer, and Benjamin Vedrenne-Cloquet, Chief Executive Officer.

Forward Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward looking statements are statements that are not historical facts. Such forward-looking statements, including with respect to the anticipated use of the proceeds of the initial public offering and the search for an initial business combination, are subject to risks and uncertainties, which could cause actual results to differ from the forward looking statements, including those set forth in the risk factors section of the prospectus used in connection with the Company’s initial public offering. No assurance can be given that the net proceeds of the offering will be used as indicated. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based, except as required by law.

Contact:


Investor and Media Relations:
Global
Citigate Dewe Rogerson
Christen Thomson
[email protected]

North America
SPAC Alpha IR+
Chris Tyson / Doug Hobbs
[email protected]
949-491-8235