Thinking about buying stock in Amyris, Nio, Plug Power, TOP Ships, or Advanced Micro Devices?

PR Newswire

NEW YORK, Dec. 31, 2020 /PRNewswire/ — InvestorsObserver issues critical PriceWatch Alerts for AMRS, NIO, PLUG, TOPS, and AMD.

To see how InvestorsObserver’s proprietary scoring system rates these stocks, view the InvestorsObserver’s PriceWatch Alert by selecting the corresponding link.

(Note: You may have to copy this link into your browser then press the [ENTER] key.)

InvestorsObserver’s PriceWatch Alerts are based on our proprietary scoring methodology. Each stock is evaluated based on short-term technical, long-term technical and fundamental factors. Each of those scores is then combined into an overall score that determines a stock’s overall suitability for investment.

 

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SOURCE InvestorsObserver

Therapeutic Solutions International Launches Campbell Neurosciences Inc as First Suicide Focused Regenerative Psychiatry Biotechnology Company

Campbell Neurosciences to License Key Intellectual Property Assets as Clinical Trials of Campbell Score and Kaihani Score are Ongoing

PR Newswire

OCEANSIDE, Calif., Dec. 31, 2020 /PRNewswire/ — Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today the launching of Campbell Neurosciences Inc as a partially owned spin-off from the Company.  The new corporation will be led by Ms. Kalina O’Connor as President and Chief Executive Officer, Dr. James Veltmeyer as Chief Medical Officer, and Ms. Jona Barnes as Chief Financial Officer. 

Campbell Neurosciences Inc has signed license agreements with Therapeutic Solutions International for access to the 9 patents filed related to the previous Campbell Neurosciences Division.  The patents are: 

1. 63/128759 Immunotherapy for Opioid Addiction
2. 63/122862 Treatment of Major Depressive Disorder and Suicidal Ideations Through Stimulation of Hippocampal Neurogenesis Utilizing Plant-Based Approaches
3. 63/105964 Protection/Regeneration of Neurological Function by Endothelial Protection/Rejuvenation using Stem Cells for Treatment of Conditions such as Chronic Traumatic Encephalopathy and Schizophrenia
4. 17/030416 Personalized Immunotherapies for Reduction of Brain Inflammation and Suicide Prevention
5. 63/077723 Immunotherapy of Schizophrenia and Schizophrenia Associated Suicidal Ideation/Suicide
6. 63/071381 Upregulation of Therapeutic T Regulatory Cells and Suppression of Suicidal Ideations in Response to Inflammation by Administration of Nutraceutical Compositions Alone or Combined with Minocycline
7. 63/068388 Methods of Determining Risk of Suicide and/or Suicidal Ideation by Immunological Assessment
8. 63/061202 Prevention of Neuroinflammation associated Memory Loss Using Nutraceutical Compositions
9. 63/057315 Neuroprotection and Neuroregeneration by Pterostilbene and Compositions Thereof

Additionally, Campbell Neurosciences Inc. has entered into purchase agreements with Therapeutic Solutions International ensuring a continued supply, at a discounted rate, of nutraceuticals which are being explored for antiinflammation/suicide prevention activity.

“I am honored that the Board of Therapeutic Solutions International has agreed to spin off the Campbell Neurosciences Division as an independent entity,” said Kalina O’Connor, Chief Executive Officer of Campbell Neurosciences Inc. “By leveraging the unique relationship between immunology, neurosciences and regenerative medicine, we aim to position ourselves as leaders in establishing a scientific and quantifiable basis to the practice of regenerative psychiatry.”

“Having collaborated with Ms. O’Connor in our work at Therapeutic Solutions International, I am pleased to be the Chief Medical Officer of Campbell Neurosciences, a company dedicated to preventing suicide,” said Dr. James Veltmeyer.  “We are dedicated to demonstrating to the world that suicide is not a choice but a disease.”

“Ms. O’Connor approached us with the idea of forming a company named after her mother, Kathleen Campbell, who was a victim of suicide.  I was impressed by Ms. O’Connor’s deep insight into biology, as well as her unwavering commitment to help other people in her mother’s situation,” said Timothy Dixon, Chairman, President and CEO of Therapeutic Solutions International. “Having worked with Ms. O’Connor and after meeting certain milestones including establishment of two clinical trials, the board decided that enhanced value can be obtained with Campbell Neurosciences spinning out as a separate entity. We will support Ms. O’Connor and Campbell Neurosciences on an ongoing basis.”

About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company’s corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/ and Campbell Neurosciences at https://www.campbellneurosciences.com

[email protected]

 

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SOURCE Therapeutic Solutions International

Reaves Utility Income Fund Section 19(a) Notice

Statement Pursuant to Section 19(a) of the Investment Company Act of 1940

PR Newswire

DENVER, Dec. 31, 2020 /PRNewswire/ — On December 31, 2020, the Reaves Utility Income Fund (NYSE MKT: UTG) (the “Fund”), a closed-end sector fund, paid a monthly distribution on its common stock of $0.18 per share to shareholders of record at the close of business on December 18, 2020.

The following table sets forth the estimated amount of the sources of distribution for purposes of Section 19 of the Investment Company Act of 1940, as amended, and the related rules adopted thereunder. In accordance with generally accepted accounting principles (“GAAP”), the Fund estimates the following percentages, of the total distribution amount per share, attributable to (i) current and prior fiscal year net investment income, (ii) net realized short-term capital gain, (iii) net realized long-term capital gain and (iv) return of capital or other capital source as a percentage of the total distribution amount. These percentages are disclosed for the current distribution as well as the fiscal year-to-date cumulative distribution amount per share for the Fund.


Current Distribution from:


Per Share ($)


%

Net Investment Income

0.06228

34.60%

Net Realized Short-Term Capital Gain

0.00945

5.25%

Net Realized Long-Term Capital Gain

0.10827

60.15%

Return of Capital or other Capital Source


0.00000


0.00%

Total (per common share)

0.18000

100.00%


Fiscal Year-to-Date Cumulative


Distributions from:


Per Share ($)


%

Net Investment Income

0.09650

26.81%

Net Realized Short-Term Capital Gain

0.04565

12.68%

Net Realized Long-Term Capital Gain

0.21785

60.51%

Return of Capital or other Capital Source


0.00000


0.00%

 Total (per common share)

0.36000

100.00%

The timing and character of distributions for federal income tax purposes are determined in accordance with income tax regulations which may differ from GAAP. As such, all or a portion of this distribution may be reportable as taxable income on your 2020 federal income tax return. The final tax character of any distribution declared in 2020 will be determined in January 2021 and reported to you on IRS Form 1099-DIV.

The amounts and sources of distributions reported in this 19(a) Notice are only estimates and not for tax reporting purposes. The actual amounts and sources of the amounts for tax reporting purposes will depend upon the Fund’s investment experience during the remainder of its fiscal year and may be subject to changes based on tax regulations. The Fund will send you a Form 1099-DIV for the calendar year that will tell you how to report these distributions for federal income tax purposes.

Presented below are return figures, based on the change in the Fund’s Net Asset Value per share (“NAV”), compared to the annualized distribution rate for this current distribution as a percentage of the NAV on the last day of the month prior to distribution record date.

Fund Performance & Distribution Information

Fiscal Year to Date (11/01/2019 through 11/30/2020)

Annualized Distribution Rate as a Percentage of NAV^

6.65%

Cumulative Distribution Rate on NAV^

1.11%

Cumulative Total Return on NAV*

6.21%

Average Annual Total Return on NAV for the 5 Year Period Ended 11/30/2020**

9.26%

^ Based on the Fund’s NAV as of November 30, 2020.

*Cumulative fiscal year-to-date return is based on the change in NAV including distributions paid and assuming reinvestment of these distributions for the period November 1, 2020 through November 30, 2020. 

**The 5 year average annual total return is based on change in NAV including distributions paid and assuming reinvestment of these distributions and is through the last business day of the month prior to the month of the current distribution record date.

While the NAV performance may be indicative of the Fund’s investment performance, it does not measure the value of a shareholder’s investment in the Fund. The value of a shareholder’s investment in the Fund is determined by the Fund’s market price, which is based on the supply and demand for the Fund’s shares in the open market. Past performance does not guarantee future results. Shareholders should not draw any conclusions about the Fund’s investment performance from the amount of this distribution or from the terms of the Fund’s Managed Distribution Plan.

Furthermore, the Board of Trustees reviews the amount of any potential distribution and the income, capital gain or capital available. The Board of Trustees will continue to monitor the Fund’s distribution level, taking into consideration the Fund’s net asset value and the financial market environment. The Fund’s distribution policy is subject to modification by the Board of Trustees at any time. The distribution rate should not be considered the dividend yield or total return on an investment in the Fund.

ALPS Portfolio Solutions Distributor, Inc., FINRA Member Firm.

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SOURCE Reaves Utility Income Fund

RedHill Biopharma Announces Positive Top-Line Safety and Efficacy Data from Phase 2 COVID-19 Study of Opaganib

Preliminary data from the non-powered U.S. Phase 2 study of 40 hospitalized patients shows that orally-administered opaganib was safe, with no material safety differences between opaganib and control arms

Consistent trends demonstrate greater improvement in reducing oxygen requirement by end of treatment at Day 14 in the opaganib-treated arm across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale

The opaganib-treated arm demonstrated a greater improvement in reaching room air within 14 days (52.6% vs. 22.2%); greater improvement in reduction to 50% supplemental oxygen by Day 14 (89.5% vs. 66.7%); a higher proportion of patients discharged by Day 14 (73.7% vs. 55.6%) and a greater reduction in the median total oxygen requirement (AUC) over 14 days (68.0% vs. 46.7%)

Top-line data from the global Phase 2/3 COVID-19 study in 270 hospitalized patients expected Q1/2021 and an interim DSMB futility analysis is expected in the coming weeks

Opaganib targets a human cell component involved in viral replication, potentially minimizing the likelihood for resistance due to viral mutations

PR Newswire

TEL AVIV, Israel and RALEIGH, N.C., Dec. 31, 2020 /PRNewswire/ — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that preliminary top-line data from its U.S. Phase 2 study with orally-administered opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with COVID-19 pneumonia demonstrated positive safety and efficacy signals.

The randomized, double-blind, placebo-controlled U.S. Phase 2 proof-of-concept study with opaganib (NCT04414618) enrolled 40 patients requiring oxygen support. The study was not powered for statistical significance and aimed to evaluate safety and identify preliminary signs of activity. Patients in the study were randomized at a 1:1 ratio to receive either opaganib or placebo on top of standard-of-care (SoC) and were followed up for up to 42 days post treatment initiation.

  • Top-line results from the study found opaganib to be safe, with no material safety differences between the opaganib and placebo treatment arms. Overall, fewer patients suffered from serious adverse events (SAEs) in the opaganib treatment arm than in the placebo arm. In this small sample size, there were few events of intubation or fatality and these were balanced between the two arms.
  • The opaganib-treated arm demonstrated a consistent trend of greater improvement in reducing oxygen requirement by end of treatment on Day 14 across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale:
    – A greater improvement in the proportion of patients reaching room air and no longer requiring oxygen support by Day 14 vs. the control arm (52.6% vs. 22.2%).
    – A greater improvement in the proportion of patients with 50% reduction in supplemental oxygen by day 14 vs. the control arm (89.5% vs. 66.7%).
    – A higher proportion of patients discharged by Day 14 vs. the control arm (73.7% vs. 55.6%).
    – A greater reduction from baseline of the median total oxygen requirement (AUC) over 14 days vs. the control arm (68.0% vs. 46.7%).

Full analysis of the data, including viral and inflammatory biomarker analyses, baseline risk factors and SoC background therapy stratifications, is expected in the coming weeks. The Company will provide the data for peer review when available.

“We are pleased with these encouraging top-line results from our exploratory Phase 2 study which confirm opaganib’s safety and demonstrate promising signals of activity when treating patients with COVID-19 and who require oxygen support. These preliminary results support our ongoing global Phase 2/3 study in severe COVID-19 pneumonia, which is expected to read out in Q1/2021. We continue to work diligently to compile a robust data set to support potential filing of global emergency use applications,” said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill.


Gilead Raday, RedHill’s Chief Operating Officer, added:
“Opaganib has a unique dual mode of action that is both anti-inflammatory and antiviral – acting on both the cause and the effects of COVID-19. Opaganib targets sphingosine kinase-2, a human cell component involved in viral replication and not the virus itself. The mounting evidence of new SARS-CoV-2 mutations emerging globally underscores the importance of this unique mechanism, which potentially minimizes the risk of viral resistance to therapy. The trends of patient improvement shown by the preliminary top-line data support the ongoing Phase 2/3 study with opaganib, which will provide a more in-depth understanding of opaganib’s activity.”

The efficacy of opaganib in severe COVID-19 pneumonia is being further explored in an ongoing global Phase 2/3 study and is expected to report top-line data in the first quarter of 2021. This study (NCT04467840) is being conducted across approximately 30 clinical sites in several countries and is on track to enroll up to 270 patients. The study has undergone two unblinded reviews of safety data by an independent Data and Safety Monitoring Board (DSMB), with unanimous recommendations to continue the study. An interim DSMB futility analysis will be conducted in the coming weeks, evaluating data from the first 135 subjects that have reached the primary endpoint.

The top-line results from the U.S. Phase 2 study of opaganib in patients hospitalized with COVID-19 pneumonia are preliminary and were provided to the Company by an independent third-party following an initial independent analysis and remain subject to additional review and analysis. Such review and analysis may result in findings inconsistent with the results disclosed in this release and may not be replicated in future studies.

About Opaganib (ABC294640, Yeliva®)

Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a U.S. Phase 2 study.

Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to ameliorate inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies[2] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

About RedHill Biopharma

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults with non-cancer pain[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers’ diarrhea in adults[5]. RedHill’s key clinical late-stage investigational development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a firstinclass SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words and includes statements regarding the timing of the reporting of a full analysis of the data from the U.S. Phase 2 trial evaluating opaganib, the timing of potential emergency use applications for opaganib and the timing of reporting of top-line data, safety analysis and of unblinded futility interim analysis for the global Phase 2/3 study with opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company’s Phase 2/3 study evaluating opaganib will not be successful; the risk of a delay in receiving top-line data from the Phase 2/2 study and in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the full analysis of data from the U.S. Phase 2 clinical study evaluating opaganib will be delayed or will differ from the preliminary data; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment, reporting of top-line data, safety analysis and/or unblinded futility interim analysis will be delayed; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia®; (v) the Company’s ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company’s Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

Logo – https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

Company contact:

Adi Frish

Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
[email protected]

Media contact (U.S.):

Bryan Gibbs

Vice President
Finn Partners
+1-212-529-2236
[email protected]

1. Opaganib is an investigational new drug, not available for commercial distribution.
2. Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.
3. Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
4. Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
5. Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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SOURCE RedHill Biopharma Ltd.

Rio2 Limited Announces Annual Grant of Equity Incentive Awards

VANCOUVER, British Columbia, Dec. 31, 2020 (GLOBE NEWSWIRE) — Rio2 Limited (“Rio2” or “the Company”) (TSXV: RIO; OTCQX: RIOFF; BVL: RIO) today announces that it has granted a total of 400,000 restricted share units to certain executive officers of the Company. The equity incentive awards have been granted pursuant to the Company’s Share Incentive Plan and are subject to vesting provisions.

ABOUT RIO2 LIMITED

Rio2 is a mining company with a focus on development and mining operations with a team that has proven technical skills as well as a successful capital markets track record. Rio2 is focused on taking its Fenix Gold Project in Chile to production in the shortest possible timeframe based on a staged development strategy. In addition to the Fenix Gold Project in development in Chile, Rio2 Limited continues to pursue additional strategic acquisitions where it can deploy its operational excellence and responsible mining practices to build a multi-asset, multi-jurisdiction, precious metals company focused in the Americas.

To learn more about Rio2 Limited, please visit: www.rio2.com or Rio2’s SEDAR profile at www.sedar.com.

ON BEHALF OF THE BOARD OF RIO2 LIMITED

Alex Black
President, CEO & Director
Email: [email protected]
Tel: 1 (604) 260-2696

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

 



Avicanna Announces Exercise and Closing of Over-Allotment Option

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES.
ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF UNITED STATES SECURITIES LAWS

TORONTO, Dec. 31, 2020 (GLOBE NEWSWIRE) — Avicanna Inc. (“Avicanna“, or the “Company“) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) is pleased to announce that further to the closing of its marketed public offering of 5,966,900 units (“Units”) of the Company at a price of $0.85 per Unit which occurred on December 8, 2020 (the “Offering”), the Agents (as defined below) have exercised their over-allotment option (the “Over-Allotment Option“) in full to sell an additional 895,034 Units at a price of $0.85 per Unit, for gross proceeds of approximately $760,780.

Including the Units sold pursuant to the Over-Allotment Option, a total of 6,861,934 Units were issued under the Offering for aggregate gross proceeds of approximately $5,832,645. Each Unit is comprised of one common share of the Company (each a “Common Share”) and one-half of one common share purchase warrant of the Company (each full warrant, a “Warrant” and collectively the “Warrants”). Each Warrant is exercisable for one Common Share at a price of $1.20 per share until December 8, 2023.

The Offering was conducted on a “best efforts” basis by a syndicate of agents led by Echelon Wealth Partners Inc., as lead agent and sole-bookrunner, and including Beacon Securities Limited and Canaccord Genuity Corp. (collectively, the “Agents”).

The Company intends to use the net proceeds of the Offering, including those proceeds raised in connection with the exercise of the Over-Allotment Option, for product development, working capital and general corporate purposes, as further described in the Company’s short form prospectus dated November 27, 2020, a copy of which is available under the Company’s profile at www.sedar.com.

The securities described in this press release have not been and will not be registered under the United States Securities Act of 1933, as amended (“U.S. Securities Act”) or any state securities laws. Accordingly, the securities may not be offered or sold in the United States (as such term is defined in Regulation S under the U.S. Securities Act) or to, or for the account or benefit of, a U.S. person (as such term is defined in Regulation S under the U.S. Securities Act) except pursuant to transactions exempt from registration under the U.S. Securities Act and under the securities laws of any applicable state. This news release does not constitute an offer to sell or a solicitation of an offer to sell any of securities in the United States.

About Avicanna Inc.

Avicanna is a diversified and vertically integrated Canadian biopharmaceutical company focused on the research, development, and commercialization of plant-derived cannabinoid-based products for the global consumer, medical, and pharmaceutical market segments.

Avicanna is an established leader in cannabinoid research and development, which it primarily conducts at its R&D headquarters in the Johnson & Johnson Innovation Centre, JLABS @ Toronto, Canada and in collaboration with leading Canadian academic and medical institutions. In addition to its developing pharmaceutical pipeline, Avicanna’s team of experts have developed and commercialized several industry leading product lines, including:

  • Pura H&W™: an advanced and clinically tested line of CBD consumer derma-cosmetic products; and,
  • RHO Phyto™: an advanced line of medical cannabis products containing varying ratios of CBD and THC currently available nation-wide across Canada in partnership with Medical Cannabis by Shoppers™, a subsidiary of Shoppers Drug Mart. RHO Phyto is the first strictly medical formulary of advanced “Cannabis 2.0” products, containing oils, sprays, capsules, creams, and gels, all 2 developed with scientific rigour, manufactured under GMP standards and supported by pre-clinical data.

With ongoing clinical trials on its derma-cosmetic (Pura H&W), medical cannabis (RHO Phyto) and a pipeline of pharmaceutical products, Avicanna’s dedication to researching the important role that cannabinoids play in an increasingly wider scope of products has been at the core of the Company’s vision since its inception. Furthermore, Avicanna’s commitment to education is demonstrated through its annual medical symposium, the Avicanna Academy educational platform, and the My Cannabis Clinic patient program through its subsidiary company.

Avicanna manages its own supply chain including cultivation and extraction through its two majority-owned subsidiaries, Sativa Nativa S.A.S. and Santa Marta Golden Hemp S.A.S., both located in Santa Marta, Colombia. Through these sustainable, economical, and industrial scale subsidiaries, Avicanna cultivates, processes, and commercializes a range of cannabis and hemp cultivars dominant in CBD, CBG, THC, and other cannabinoids for use as active pharmaceutical ingredients. Avicanna’s Avesta Genetica program specializes in the development and optimization of rare cultivars for commercial production along with feminized seeds for global export. In June 2020, Avicanna made history with a shipment of hemp seeds to the United States of America by completing the first ever export of hemp seeds from Colombia.

SOURCE: Avicanna Inc.

Stay Connected

For more information about Avicanna, visit www.avicanna.com, call 1-647-243-5283, or contact Setu Purohit, President by email at [email protected].


Cautionary Note Regarding Forward-Looking Information and Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe”, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by the Company, including satisfaction of regulatory requirements in various jurisdictions and the use of proceeds from the Offering.

Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment; and the availability of licenses, approvals and permits. Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to current and future market conditions, including the market price of the common shares of the Company, the delay or failure to receive regulatory approvals, and the risk factors set out in the Company’s annual information form dated April 15, 2020, filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com.



CleanSpark Achieves Another Record Revenue Year, Discusses Growth Plans in Annual Statement to Shareholders

CleanSpark Inc. Delivers in Excess of 100% Year-Over-Year Revenue Improvement for the Third-Consecutive Year.

PR Newswire

SALT LAKE CITY, Dec. 31, 2020 /PRNewswire/ — CleanSpark, Inc. (Nasdaq: CLSK), (“CleanSpark, or the Company”), an advanced software and controls technology solutions company focused on solving modern energy challenges, is pleased to update its shareholders and further comment on the Company’s financial results presented in its most recent Form 10-K. The Company recommends that readers also review the previously filed 10-K in its entirety, which is available free of charge to all interested parties on its website or on www.sec.gov.

CleanSpark Looks Toward 300% Revenue Growth

Dear Fellow Shareholders,

The COVID-19 pandemic presented many hardships throughout the year that have touched us all in some way or another. With the recent progress being made by the medical community and a growing optimism surrounding the economy, we are increasingly confident about the status of our company and the promise of the future. As we discussed in our comments following the report of our third-quarter results, we consider the Company extremely fortunate to have continued to thrive during the global challenges of 2020. The professionalism demonstrated by the CleanSpark team to readily shift to a ‘work-at-home’ environment in a seamless transition was certainly the foundation for our continued successes. We found ourselves in the midst of commissioning some of our first international microgrid deployments just as countries around the world closed their borders to foreign travel. In response, our software team was able to successfully and rapidly develop a remote deployment and commissioning strategy that enables our partners to commission our systems remotely, including those located outside of the country. These upgrades, while mandatory in the face of COVID-19, will almost certainly improve our efficiencies and significantly reduce costs in future remote deployments as we continue to execute on our ‘one to many’ strategy to develop far reaching partnerships to enhance distribution. 

Prior to CleanSpark completing a successful uplist to the Nasdaq stock market last January, the Company’s management team forecast a revenue increase exceeding 100%. Not only were we able to achieve our projected numbers, but the Company also completed a series of strategic acquisitions that should prove to be tremendously valuable to all shareholders in the coming years. In addition to increasing our gross revenues, we’ve focused on streamlining all aspects of our operations to reach our goal of profitability within the coming year and paved this road with a series of carefully planned corporate transactions.  

We’re proud of the efforts of our amazing stakeholders across the entire enterprise for successfully achieving a number of significant wins for the Company, including:

  • During our 2020 fiscal year, we completed successful acquisitions of GridFabric and p2klabs. Both acquired companies are cashflow-positive and provide us with entirely new verticals for growth. Subsequent policy shifts (FERC2222) should further accelerate growth in the GridFabric segment.
  • The September ruling by the Federal Energy Regulation Commission, FERC 2222, is a massive policy shift in favor of the distributed energy market in particular and a significant win for CleanSpark. It should open up additional value streams for microgrid developers and owners to fully participate in wholesale markets. These opportunities are expected to dramatically improve microgrid economics and stimulate future deployments. Microgrid developers of all sizes should now be able to leverage CleanSpark’s robust portfolio of technologies to tap into these opportunities and offer significant value for their customers. 
  • CleanSpark successfully commissioned its first two microgrids within Costa Rica. The commercial customers utilize mPulse to manage the day-to-day performance of the power system, maximizing the energy savings while providing certainty of operations through the Tesla  battery energy storage systems provided on site.
  • In early December 2020, we acquired ATL Data Centers in an ‘all-stock’ transaction. By leveraging our proprietary technologies, the Company expects to increase Bitcoin production while lowering total energy costs, thereby maximizing overall profitability. The anticipation of producing Bitcoins at what we believe will be potentially the lowest total energy cost in America is expected to be a substantial opportunity to market our proprietary energy solutions to other energy intensive operations throughout the world.
  • Since the acquisition, Bitcoin has traded as high as $28,500 per coin.  We’ve also ordered an additional 1,500 ASICS miners since the closing of the ATL transaction, with plans to fully deploy this order of miners in January 2021. Management believes that recent moves by companies such as Square, PayPal, MicroStrategy and others have furthered the validation of Bitcoin, and expects that energy efficiency will soon become a priority. The addition of new miners, paired with the recent market performance of Bitcoin prompted the company to raise our revenue guidance to $30M for fiscal 2021, 300% of what we successfully delivered in 2020.
  • The Company further improved its corporate governance and oversight by appointing two new independent board members and creating a fully independent audit and compensation committee. CleanSpark enhanced its reliable, talented, and goal-oriented management team, including the promotion of Zach Bradford as its Chief Executive Officer, the appointments of Lori Love, as Chief Financial Officer, Amer Tadayon as Chief Revenue Officer, and Marty Weishaar as Vice President of Marketing. The Company’s co-founder and former CEO, Matthew Schultz assumed new duties as the Executive Chairman. Our team has now grown to 62 full-time staff members as of December 29, 2020.
  • Along with ReJoule, Inc., we were jointly awarded a $2.9 Million grant from the California Energy Commission with support from the Ford Motor Company  for second-life EV battery deployments. The first joint deployment is expected to occur in the next quarter.
  • The software and product team launched new features for our two product lines
    • In mVSO, we began the year with an expanded equipment library for energy storage that has only grown over the last 9 months and continued our improvements by releasing a revamped user experience and additional functionality around modeling different rate structures and demand response programs.
    • mPulse published four separate feature-set releases to customers as well as an expanded web portal to enable self-service of user and alert management, pre-configured performance reports, and custom data exports.
  • We’re looking forward to accelerating our software capabilities and features across the CleanSpark family of products, including GridFabric. We believe the growth will be due in part to the increase in our software team that has nearly doubled in size within the last two months.
  • CleanSpark commissioned multiple microgrids controlled by our mPulse hybrid-cloud control software in our fiscal 2020 year. These microgrids span the industrial, commercial, and indoor agriculture industries. mPulse is already optimizing renewable energy usage and providing energy cost savings at each site. In addition, we shipped over 70 Switchgear units to commercial and industrial customers ensuring resiliency and seamless power availability. These units now support US Embassies, critical water treatment facilities and a number of locations of the nation’s largest retailer.
  • In October, the Company closed an underwritten public offering of its common stock and received gross proceeds of $40 million before deducting underwriting expenses and fees. CleanSpark intends to continue to use the net proceeds from the offering to support its future growth through increased sales and marketing, product development and software enhancements/ improvements, and additional strategic mergers and acquisitions, along with general corporate purposes.

Outlook

The Company expects the somewhat cyclical nature of our business to continue. As an example, approximately 10% of our fiscal 2020 revenue was realized in the quarter ending December 31, 2019.  We anticipate this trend will continue in fiscal 2021 and we forecast that our second and third fiscal quarters will again be our strongest. We expect to generate $20 million in revenue related to our current business segments and we expect the recent acquisition of ATL Data Center to contribute a minimum of $10 million in additional Bitcoin-based (BTC-USD) revenues for 2021. We are working diligently to expand the data center capacity allowing us to further increase these initial estimates, but the Company’s guidance will remain somewhat conservative until the expansion has been completed and we have sufficient data to forecast a firm outlook. Finally, as we have only recently begun to integrate ATL into our operations, we have not yet measured the potential additional value expected to be derived from the demonstration of our energy technologies within the data center for additional microgrid deployment and sales opportunities.

We are thankful for the dedicated support from all of our stakeholders. We continue to put our efforts towards increasing shareholder value, achieving profitability, and improving our margin profile through increased software and service revenues. We are aggressively seeking new acquisition opportunities for 2021, along with identifying partnerships and product enhancements that will expedite our growth as a company. Finally, our previously discussed data center and Bitcoin mining expansion has begun as of this writing, while we continue to seek additional growth opportunities.

We sincerely, thank you for your continued support of CleanSpark. 

With warmest regards, and wishes for a very healthy, happy and prosperous 2021, your fellow shareholders,

Zach and Matt

Zachary Bradford, CEO
and
S. Matthew Schultz, Executive Chairman

Parties interested in learning more about CleanSpark products and services are encouraged to inquire by contacting the Company directly at [email protected] or visiting the Company’s website at www.cleanspark.com.

Investors are encouraged to contact the Company at [email protected], or visiting the Company’s website at https://ir.cleanspark.com/

About CleanSpark:

CleanSpark, Inc., a Nevada corporation, is in the business of providing advanced software and controls technology solutions to solve modern energy challenges.  We have a suite of software solutions that provide end-to-end microgrid energy modeling, energy market communications, and energy management solutions.  Our offerings consist of intelligent energy monitoring and controls, intelligent microgrid design software, middleware communications protocols for the energy industry, energy system engineering, and software consulting services. 

Through its wholly owned subsidiary ATL Data Centers LLC, CleanSpark owns and operates a data center that provides customers with traditional on-site and cloud-based data center services. The Company also owns and operates a fleet of over 3,400 ASIC (application-specific integrated circuit) Bitcoin miners producing over 200 PH/s in mining capacity. Capacity is expected to increase to over 5,900 ASIC and 300 PH/s in mining capacity by early 2021. CleanSpark plans to apply its technologies with a goal of mining bitcoins at the lowest energy prices in the United States. For more information, visit

Forward-Looking Statements:

CleanSpark cautions you that statements in this press release that are not a description of historical facts are forward-looking statements. These statements are based on CleanSpark’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by CleanSpark that any of our plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in our business, including, without limitation: the successful integration of ATL into CleanSpark, the price of Bitcoin (BTC), the fitness of our energy software and solutions for this particular application or market, the expectations of future revenue growth may not be realized, ongoing demand for our software products and related services, the impact of global pandemics (including COVID-19) on the demand for our products and services; and other risks described in our prior press releases and in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our 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 we undertake no obligation to revise or update this press release to reflect events or circumstances 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.

Contact – Investor Relations:
CleanSpark Inc.
Investor Relations
(801)-244-4405

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SOURCE CleanSpark, Inc.

RLH Merger Investigation: Halper Sadeh LLP Announces Investigation Into Whether the Sale of Red Lion Hotels Corporation Is Fair to Shareholders; Investors Are Encouraged to Contact the Firm – RLH

RLH Merger Investigation: Halper Sadeh LLP Announces Investigation Into Whether the Sale of Red Lion Hotels Corporation Is Fair to Shareholders; Investors Are Encouraged to Contact the Firm – RLH

NEW YORK–(BUSINESS WIRE)–
Halper Sadeh LLP, a global investor rights law firm, is investigating whether the sale of Red Lion Hotels Corporation (“Red Lion” or “RLH”) (NYSE: RLH) to Sonesta International Hotels Corporation for $3.50 per share in cash is fair to RLH shareholders.

Halper Sadeh encourages RLH shareholders to click here to learn more about their legal rights and options or contact Daniel Sadeh or Zachary Halper at (212) 763-0060 or [email protected] or [email protected].

The investigation concerns whether RLH and its board of directors violated the federal securities laws and/or breached their fiduciary duties to shareholders by failing to: (1) obtain the best possible price for RLH shareholders; (2) determine whether Sonesta is underpaying for RLH; and (3) disclose all material information necessary for RLH shareholders to adequately assess and value the merger consideration. On behalf of RLH shareholders, Halper Sadeh LLP may seek increased consideration for shareholders, additional disclosures and information concerning the proposed transaction, or other relief and benefits.

Halper Sadeh encourages RLH shareholders to click here to learn more about their legal rights and options or contact Daniel Sadeh or Zachary Halper at (212) 763-0060 or [email protected] or [email protected].

Halper Sadeh LLP represents investors all over the world who have fallen victim to securities fraud and corporate misconduct. Our attorneys have been instrumental in implementing corporate reforms and recovering millions of dollars on behalf of defrauded investors.

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

Halper Sadeh LLP

Daniel Sadeh, Esq.

Zachary Halper, Esq.

(212) 763-0060

[email protected]

[email protected]

https://www.halpersadeh.com

KEYWORDS: United States North America Illinois New York

INDUSTRY KEYWORDS: Other Professional Services Professional Services Legal

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Taylor Devices Announces Second Quarter and Six-Month Results

PR Newswire

NORTH TONAWANDA, N.Y., Dec. 31, 2020 /PRNewswire/ — Taylor Devices, Inc. (NASDAQ SmallCap: “TAYD”) announced today that it had 2nd quarter Net earnings of $645,290, down from last year’s 2nd quarter Net earnings of $917,006.  Net earnings for the 1st six months were $821,301, also down from last year’s Net earnings for the 1st six months of $1,271,583.

Sales for the 2nd quarter were $4,717,597, lower than last year’s 2nd quarter sales of $7,702,425.  Sales for the 1st six months were $10,477,054, lower than last year’s 1st six-month sales of $13,411,064.

“Our FY21 Q2 sales finished significantly lower than last year’s Q2 sales due primarily to the order placement delays we have been experiencing since the onset of the COVID-19 Coronavirus Pandemic, particularly for orders and resultant sales from our domestic Construction customers,” stated Tim Sopko, CEO.   He further commented, “This lower sales volume combined with continued greater percentage of sales to our Construction customers in Asia where margins are more challenged resulted in lower net earnings.”  He continued, “Earnings would have been lower still if not for the favorable impact of a Paycheck Protection Plan (PPP) loan received as part of the CARES Act which was forgiven in the quarter.”  He added, “This has helped us keep our experienced and dedicated work force intact during these trying times which, when combined with lower business volume, has also allowed us to accelerate progress on our business systems and processes improvement initiatives that are critical to supporting our profitable growth”.

He concluded, “I continue to be thoroughly impressed by how well our employees are managing the challenges of this very exceptional year thus far and remain hopeful that this Pandemic ends sooner rather than later with the recent release of vaccines to the public”.

The company’s firm order backlog is $15,400,000 at the end of the 1st six months as compared to $9,800,000 at the beginning of the fiscal year.  

Taylor Devices, Inc. is a 65-year old company engaged in the design, development, manufacture and marketing of shock absorption, rate control and energy storage devices for use in various types of vehicles, machinery, equipment and structures.  The company continues to target growth in the domestic Aerospace and Defense market as well as global Structural Construction and Industrial markets.


2nd Quarter  (3 months ended 11/30/20 & 11/30/19) 


F/Y 21


F/Y 20

Sales                                                                                    

$4,717,597

$7,702,425

Net Earnings                                              

$   645,290

$   917,006

Earnings per Share                                    

$         0.19

$         0.26

Shares Outstanding                                                                 

3,487,192

3,478,716


1st Half  (6 months ended 11/30/20 & 11/30/19)               

  F/Y 21 


F/Y 20

Sales                                                                                

$10,477,054

$13,411,064

Net Earnings                                                                   

$     821,301

$  1,271,583

Earnings per Share                                                          

$           0.24

$           0.37

Shares Outstanding                                                         

3,487,299

3,478,795

 

Taylor’s website can be visited at:  www.taylordevices.com ; with company newsletters and other pertinent information at www.taylordevices.com/investors.

Taylor Devices, Inc.

Contact: 
Artie Regan
Regan & Associates, Inc.
(212) 587-3005 (phone)
(212) 587-3006 (fax)
[email protected]

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SOURCE Taylor Devices, Inc.

Moderna Announces Publication of Results from the Pivotal Phase 3 Trial of the Moderna COVID-19 Vaccine in TheNew England Journal of Medicine

Moderna Announces Publication of Results from the Pivotal Phase 3 Trial of the Moderna COVID-19 Vaccine in TheNew England Journal of Medicine

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that interim safety and primary efficacy results from the Phase 3 trial of the Moderna COVID-19 Vaccine (mRNA-1273) were published in the New England Journal of Medicine. The 100 μg two-dose regime of the Moderna COVID-19 Vaccine given 28 days apart was well-tolerated and demonstrated vaccine efficacy of 94.1% against COVID-19. The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

The primary endpoint of the Phase 3 COVE study was based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This final analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the Moderna COVID-19 Vaccine group, corresponding to a 94.1% vaccine efficacy (95% CI 89.3-96.8%; p<0.0001).

A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.

The Moderna COVID-19 Vaccine exhibited a favorable tolerability and safety profile. Based on a data cut-off date of November 25, 2020, the study had a median of 9 weeks of safety data available after the second dose and contributed to the main safety dataset. Baseline demographic characteristics were generally balanced between the placebo and vaccine groups. Among these participants, the mean age was 51.4 years, 47.3% were female, 24.8% were older than 65 years, and 16.7% were under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease. Participants from communities of color represented 37% of the study population, similar to the diversity of the U.S. at large. This included 20.5% participants who identify as Hispanic or LatinX, and 10.2% participants who identify as Black or African American.

The most common solicited adverse reactions (ARs) after the two-dose series was injection site pain (86.0%). Solicited systemic adverse events occurred more often in the Moderna COVID-19 vaccine group (54.9% and 79.4%) than in the placebo (42.2% and 36.5%) group after both the first dose and the second dose respectively and were most commonly headache, fatigue and myalgia. While the majority of these ARs were mild (grade 1) or moderate (grade 2), there was a higher occurrence of severe (grade 3) reactions in the Moderna COVID-19 Vaccine group after the first (2.9%) and second (15.8%) injections. The majority of local solicited ARs occurred within the first one to two days after injection and generally persisted for a median of one to two days. Safety data continues to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the NIH. All participants in the COVE study will be monitored for two years after their second dose to assess long-term protection and safety.

The Phase 3 COVE study is ongoing and will continue to follow participants for two years. Additional data to be collected will include longer term safety follow-up, duration of protection against COVID-19, and efficacy against asymptomatic SARS-CoV-2 infection. Moderna is also conducting a Phase 2/3 study of the Moderna COVID-19 vaccine in adolescents 12 to under 18 years of age. Additional studies are planned to evaluate the Moderna COVID-19 Vaccine in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

About the Moderna COVID-19 Vaccine

The Moderna COVID-19 Vaccine (previously referred to as mRNA-1273) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrollment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of the vaccine was published in The New England Journal of Medicine. On November 30, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) with the European Medicines Agency. On December 3, a letter to the editor was published in TheNew England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination). On December 18, 2020, the FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older.

The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is supporting the continued research and development of the Moderna COVID-19 Vaccine with $955 million in federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of the Moderna COVID-19 Vaccine under U.S. Department of Defense contract no. W911QY-20-C-0100.

A summary of the company’s work to date on COVID-19 can be found here.

AUTHORIZED USE:

The Moderna COVID-19 Vaccine has been authorized for emergency use by the U.S. Food and Drug Administration (FDA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older and has been authorized by Health Canada for the immunization of Canadians 18 years of age and older under an Interim Order. Moderna has submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.

IMPORTANT SAFETY INFORMATION

  • Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
  • Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine. Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/).
  • Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID-19 Vaccine.
  • The Moderna COVID-19 Vaccine may not protect all vaccine recipients.
  • Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site.
  • Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion.
  • There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.
  • Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.
  • Vaccination providers must complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words ” Moderna COVID- 19 Vaccine EUA ” in the description section of the report.

About Moderna

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company’s development of a vaccine against the novel coronavirus, the potential for the Moderna COVID-19 Vaccine to prevent COVID-19 disease and slow the spread of SARS-CoV-2, and the safety profile for the Moderna COVID-19 Vaccine. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

Moderna

Media:

Colleen Hussey

Director, Corporate Communications

617-335-1374

[email protected]

Investors:

Lavina Talukdar

Head of Investor Relations

617-209-5834

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: FDA Health Infectious Diseases Clinical Trials Pharmaceutical Biotechnology

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