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Release – Tonix Pharmaceuticals Initiates Enrollment in Phase 2 ‘UPLIFT’ Study of TNX-601 ER (Tianeptine Hemioxalate Extended-Release Tablets) for the Treatment of Major Depressive Disorder (MDD)

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March 16, 2023 7:00am EDTDownload as PDF

Results from Planned Interim Analysis Expected Fourth Quarter 2023

Approximately 21 Million Adults in U.S. Suffer From a Major Depressive Episode Each Year

TNX-601 ER is a Once-Daily Tablet that is Bioequivalent to Three-Times-Daily Tianeptine Sodium Immediate Release (IR) that has been available in Europe, Asia and Latin America for More than Three Decades

Tianeptine IR is Associated with Low Incidences of Sexual Dysfunction, Sleep Disruption, Sedation, Weight Gain, and Cognitive Impairment Compared with Traditional Monoaminergic Antidepressants

TNX-601 ER is a New Chemical Entity in the U.S. and Represents a Potential Innovative Approach to Addressing Depression: Restoration of Neuroplasticity and Neurogenesis Rather than Modulation of Neurotransmitter Levels and Activity

CHATHAM, N.J., March 16, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 2 ‘UPLIFT’ study of TNX-601 ER1 (tianeptine hemioxalate extended-release tablets) for the treatment of major depressive disorder (MDD). The double-blind, placebo-controlled registrational-quality study has a target enrollment of 300 participants at approximately 30 sites across the U.S. Results from a planned interim analysis are expected to be released in the fourth quarter of 2023.

The proprietary once-daily formulation of TNX-601 ER was designed to be bioequivalent to the three-times-a-day formulation of tianeptine sodium (amorphous) immediate release (IR) tablets. IR tianeptine sodium has been available in Europe and many countries in Asia and Latin America for the treatment of MDD for more than three decades since being first marketed in France in 1989. No tianeptine-containing product has been approved by the U.S. Food and Drug Administration (FDA).

“Despite the availability of several classes of MDD treatments in the U.S. that directly modulate neurotransmitters and their synaptic receptors, there remains an unmet need for novel approaches,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In animal studies, TNX-601 ER has a unique mechanism of action that restores brain neuroplasticity by exerting biological effects on neurons and glial cells that increase arborization of dendrites in critical hippocampal circuits.2 In animal models, tianeptine also reverses stress-induced impairments in synaptic glutamate neurotransmission, and it restores hippocampal neurogenesis.2”

Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals said, “After a decade of development of our proprietary once-daily tianeptine formulation, it is very gratifying to enter the next stage of clinical testing required to make TNX-601 ER available to those suffering from MDD in the U.S. TNX-601 ER not only has the potential to relieve depressive symptoms, but also to improve the quality of life and resiliency for the millions of MDD sufferers. The short and long-term safety of tianeptine sodium IR has been well-established based on its clinical use outside the US.”

Dr. Sullivan added, “The efficacy of tianeptine sodium IR has repeatedly been shown to be comparable with that of either selective serotonin reuptake inhibitor (SSRI) or tricyclic antidepressants3,4 while being associated with a lower incidence of sexual dysfunction, derangement of sleep architecture, sedation, weight gain, or cognitive impairment.5-7 Given tianeptine’s metabolic pathway, which is independent of the hepatic cytochrome P450 system, we believe that TNX-601 ER has a reduced risk of drug-drug interactions compared to antidepressants marketed in the U.S.7

“MDD is a seriously disabling condition that is also often associated with suicidal behavior. Extensive animal studies have taught us that tianeptine restores the stress-induced deficits in neuroplasticity and neurogenesis. The dramatic impact of tianeptine on a brain experiencing many types of stress is best illustrated by the effects it has in restoring dendritic arborization and spine synapse remodeling of pyramidal neurons in the CA3 region of hippocampus, as well as new neuron formation and their microglia-mediated integration into neuronal networks of the hippocampal formation. With an estimated 21 million individuals suffering from a major depressive episode each year in the U.S., it’s exciting to move beyond neurotransmitter modulation and begin an era where MDD may be treated by enhancing a resilient biological phenotype of neurons and glial cells under stress.”

1TNX-601 ER is in the Phase 2 stage of development and is not approved for any indication
2McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249.
3Jeon, H. J., et al. .J. Clin. Psychopharmacol. 2014, 34 (2), 218–225.
4Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
5Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.
6Costa e Silva, J. A., et al. Neuropsychobiology 1997, 35 (1), 24–29.
7Wagstaff, A. J. et al. CNS Drugs 2001, 15 (3), 231–259.

About the Phase 2 UPLIFT Study

The Phase 2 UPLIFT study, TNX-TI-M201, is a double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-601 ER taken by mouth once-daily for 6 weeks for the treatment of MDD. It is a parallel design study with two arms,   a TNX-601 ER 39.4 mg arm and a placebo arm. A total of 300 participants will be randomized in a 1:1 ratio into the two arms across approximately 30 U.S. sites, enrolling adult patients 18-65 years old with a DSM-5 diagnosis of depression and a duration for the current major depressive episode (MDE) of at least 12 weeks. The primary efficacy endpoint is mean change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. Key secondary efficacy endpoints include the Clinical Global Impression of Severity Scale (CGI-S) and the Sheehan Disability Scale (SDS). An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of potential sample size re-estimation, currently anticipated in the fourth quarter of 2023. A 24-week open-label extension study, TNX-TI-M202, is planned to receive patients completing the UPLIFT study.

For more information, see ClinicalTrials.gov Identifier: NCT05686408

About Major Depressive Disorder (Depression)

According to the National Institute of Mental Health, an estimated 21 million adults in the U.S. in 2020 experienced at least one major depressive episode1, with highest prevalence among individuals aged 18-25 at a rate of 17.0%. Depression is a condition characterized by symptoms such as a depressed mood or loss of interest or pleasure in daily activities most of the time for two weeks or more, accompanied by appetite changes, sleep disturbances, motor restlessness or retardation, loss of energy, feelings of worthlessness or excessive guilt, poor concentration, and suicidal thoughts and behavior. These symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The majority of people who suffer from depression do not respond adequately to initial antidepressant therapy.2 The current FDA approved drugs for long term monotherapy treatment of MDD include selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and Auvelity® (dextromethorphan HBr-bupropion HCl).   Dextromethorphan is a direct antagonist of the NMDA-type glutamate receptor.

1Data Courtesy of SAMHSA on Past Year Prevalence of Major Depressive Episode Among U.S. Adults (2020). Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml
2Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).

About TNX-601 ER

TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a novel oral formulation of tianeptine hemioxalate designed for once-daily daytime dosing in development as a candidate for the treatment for MDD, posttraumatic stress disorder, and neurocognitive dysfunction associated with corticosteroid use. Tianeptine sodium (amorphous) immediate release (dosed 3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently there is no tianeptine-containing product approved in the U.S. and no extended-release tianeptine product approved in any jurisdiction. Tonix discovered a novel oxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known salt forms of tianeptine. Tianeptine is believed to work in depression as an indirect modulator of the glutamatergic system, without direct binding NMDA, AMPA or kainate receptors. Tianeptine reverses stress induced increases in AMPA receptor trafficking, restores hippocampal long-term potentiation and neurogenesis, and reverses the negative neuroplastic changes from stress and corticosteroid exposure. In contrast with the modulation of neurotransmitter levels and activity at synaptic receptors like traditional antidepressants, in animal models tianeptine restores dendritic arborization of pyramidal neurons in the CA3 region of hippocampus and in the dentate gyrus region promotes new neuron formation and integration into hippocampal networks.1 Tianeptine’s enhancement of neuroplasticity in animal models of stress implies a mechanism of action involving indirect glutamatergic modulation, which makes TNX-601 ER’s properties distinct from traditional monoaminergic antidepressants in the U.S. and contributes to its potential for clinical indications beyond MDD and stress disorders. Tianeptine and its MC5 metabolite are also weak mu-opioid receptor (MOR) agonists that present a potential abuse liability if illicitly misused in large quantities (typically abused at 8-80 times the therapeutic dose on a daily basis2). In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treated3 suggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine does not appear to result in dependence or withdrawal symptoms following 6-weeks4-8, 3-months9, or 12-months10 of treatment. The ER formulation of TNX-601 includes several potentially abuse deterrent ingredients include gel forming polymers which impede extraction. In addition, the tablet’s hardness makes it difficult to crush, cut or grind to fine particle size, which potentially hinders efforts to misuse by insufflation or intravenous routes. Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may also be used to treat posttraumatic stress disorder (PTSD), and neurocognitive dysfunction associated with corticosteroid use. TNX-601 ER is expected to have patent protection through 2037. 

1McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249.
2Lauhan, R., et al. Psychosomatics 2018, 59 (6), 547–53.
3Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re- Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012.
4Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
5Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.
6Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.
7Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.
8Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.
9Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.
10Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, No. 15, 61–65.

About Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition, for which a Phase 2 study was initiated in the third quarter of 2022. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is currently enrolling with interim data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation of tianeptine being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900, a class of broad-spectrum small molecule oral antivirals.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

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

Olipriya Das, Ph.D. (media)
Russo Partners
[email protected]
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
[email protected]
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released March 16, 2023

Release – Comtech Successfully Tests and Validates 5G Connection Over Satellite

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Research News and Market Data on CMTL

Mar 15, 2023 9:06 AM

Comtech Collaborates with Leading MNO in Greece and Other Technology Leaders to Demonstrate the Benefits of Blended 5G and Satellite Services

MELVILLE, N.Y. –
March 15, 2023–Comtech announced today, in collaboration with three global technology leaders: Cloud Signals, Hellas Sat, and a leading Mobile Network Operator (MNO), that the companies successfully tested and validated 5G connectivity over a satellite network in Greece.

During the demonstration, a commercial 5G node was connected to the leading MNO’s 5G testbed network and relayed over a satellite link provided by the Hellas Sat.

“This demonstration showcased our ability to easily blend satellite and terrestrial technologies to deliver 5G capabilities to remote areas that are unconnected or underserved by traditional terrestrial and wireless infrastructures,” said Ken Peterman, President and CEO, Comtech. “By working with Cloud Signals, Hellas Sat and the leading MNO, we were able to deliver a wide range of 5G satellite-enabled services, which can create incredible value for customers across Greece and bridge the digital divide in disconnected parts of the world.”

Comtech’s technology leadership was a significant enabler for this breakthrough demonstration, which included its ELEVATE Very Small Aperture Terminal solution that delivered high speed backhaul services for the 5G satellite-based connection.

“After observing a real need for providing 5G network onboard commercial and government maritime vessels, we are delighted to showcase that it can work by successfully transporting, via satellite, an end-to-end live 5G stream with the help of our partners,” said Dr. Christos Papachristos, CEO, Cloud Signals. “What remains to be done is a commercial cooperation and a market launch for our service.”

Cloud Signals specializes in the development of space technologies and is based in Athens, Greece.

“Satellites play an essential role in helping MNOs serve customers in remote and underserved areas, being a flexible, cost-efficient, scalable, and reliable solution for delivering communication services. In collaboration with our partners, using our Hellas Sat 3 satellite at 39o East, we demonstrated the substantial impact of satellite communications in the advancement of the 5G infrastructure,” said Christodoulos Protopapas, CEO, Hellas Sat.

Hellas Sat is a premium satellite services provider that owns and operates satellites delivering services in Europe, the Middle East, and Southern Africa.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing space and satellite communications technologies, terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

About Cloud Signals

Cloud Signals is a startup specialized in the development of space technologies based in Athens, Greece. In 2021, the company was selected among the first incubatees of ESA BIC (Business Incubation Centre) Greece. The startup is developing a 5G cellular backhaul interface to provide, among others, maritime connectivity to passenger boats in the sea. GEO and LEO satellites are part of the trials that are currently being deployed with the largest mobile service operators in the country.

About Hellas Sat

Hellas Sat is a premium satellite services provider that owns and operates three satellites delivering high-quality, cost-effective video, broadband and data services in Europe, Middle East and Southern Africa. The Company also provides managed services such as digital broadcasting and connectivity to its customers from its own premises in Greece and Cyprus as well as through its network of partners around the world. Hellas Sat is a subsidiary of Arabsat and is based in Greece and Cyprus.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

View source version on businesswire.com: https://www.businesswire.com/news/home/20230315005545/en/

Investor Relations

Robert Samuels

631-962-7102

[email protected]

Media Contact

Jamie Clegg

480-532-2523

[email protected]

Release – Onconova Therapeutics Announces Upcoming Poster Presentations at The Aacr Annual Meeting

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Mar 15, 2023

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NEWTOWN, Pa., March 15, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced the publication of two abstracts that have been accepted for poster presentations at the American Association for Cancer Research (AACR) Annual Meeting, which is taking place at the Orange County Convention Center in Orlando, Florida from April 14 – 19, 2023.

The full texts of the published abstracts can be found on the AACR Annual Meeting website. The corresponding posters will be presented during the “Cyclin-dependent Kinases and Cyclin-dependent Kinase Inhibitors” poster session, which is taking place from 9:00 a.m. – 12:30 p.m. ET on April 19, 2023. Additional information on the posters is shown below.

Poster Title: Synergistic activity of the CDK4/6 antagonist narazaciclib (ON123300) with irreversible BTK inhibition in ibrutinib-resistant mantle cell lymphoma

Abstract Number: 5974

This poster will describe studies evaluating narazaciclib in preclinical models of mantle cell lymphoma (MCL). Results from these studies demonstrated narazaciclib’s single-agent antitumor activity in MCL cell lines independent of their sensitivity to ibrutinib, which is a Bruton’s tyrosine kinase inhibitor (BTKi) approved by the U.S. Food and Drug Administration (FDA) for the treatment of MCL. When combining narazaciclib with ibrutinib, synergistic increases in antitumor activity against both BTKi-resistant and BTKi-sensitive MCL cell lines were observed.

Additional analyses showed that narazaciclib’s antitumor activity against the evaluated MCL cell lines was superior to that of the FDA-approved CDK 4/6 inhibitors palbociclib and ribociclib, and similar to that of the FDA-approved CDK 4/6 inhibitor abemaciclib. Treatment with narazaciclib also led to tumor growth inhibition without detectable toxicity in a chicken embryo chorioallantoic membrane (CAM) xenograft model of MCL.

Poster Title: Differential targets engaged by narazaciclib in comparison to the approved CDK4/6 inhibitors contribute to enhanced inhibition of tumor cell growth

Abstract Number: 5987

This poster will describe cell-based, in vitro, and bioinformatic analyses comparing narazaciclib and palbociclib. Results from a cell-based murine mammary carcinoma model showed a stronger induction of programmed cell death with narazaciclib compared to palbociclib. In vitro and cell-based analyses revealed multiple targets that are engaged by narazaciclib but not by palbociclib. These targets included BUB1, the overexpression of which is correlated with poor survival in triple negative breast cancer. The results of additional cell-based assays that will be described in the poster suggest that narazaciclib may promote antitumor immunity and show that combining narazaciclib with autophagy inhibitors sensitizes breast cancer cells to cell death.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose escalation and expansion studies. These trials are currently underway in the United States and China. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also planning a combination trial of narazaciclib with estrogen blockade in advanced endometrial cancer, as well as its clinical study in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa.

For more information, please visit www.onconova.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
[email protected]

Release – Schwazze’s New Mexico Retail Banner, R.Greenleaf, Launches New Ecommerce Customer Experience

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Research News and Market Data on SHWZ

March 13, 2023

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NEO: SHWZ
             OTCQX: SHWZ

R.Greenleaf Paves Way for Direct Commerce Relationship with Customers, 
Provides Seamless, Time-Saving Shopping Experience

DENVER, March 13, 2023 /PRNewswire/ – Schwazze, (NEO: SHWZ) (OTCQX: SHWZ) (“Schwazze” or the “Company”), announces the launch of a new ecommerce shop site for R.Greenleaf, its New-Mexico based retail banner with 17 locations throughout the state. This new shopping experience, available at http://rgreenleaf.com, allows customers to ‘skip the line and order online’ by ordering ahead to reserve product and picking up in store. Customers can create an account on the new shop site to access prior orders and receive special offers while also enrolling in R.Greenleaf’s customer loyalty program, Gratify.

   

“We are excited to bring the convenience of ecommerce shopping to all of our R.Greenleaf locations. Our enhanced online shopping experience allows us to deliver our brands, product assortment and dedicated service to customers in all of our neighborhoods as we continue to expand throughout the state,” said Ken Diehl, Division President – New Mexico.    

R.Greenleaf, offering a wide variety of quality products serviced by top-notch, knowledgeable staff, has grown from 10 locations to now 17 since Schwazze’s acquisition nearly one year ago. All locations serve the needs of medical patients as well as recreational consumers.

Since April 2020, Schwazze has acquired, announced the planned acquisition of, or opened 44 cannabis dispensaries as well as seven cultivation facilities and two manufacturing assets in Colorado and New Mexico. In May 2021, Schwazze announced its BioSciences division and in August 2021 it commenced home delivery services in Colorado.

About Schwazze

Schwazze (NEO: SHWZ) (OTCQX: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements are not guarantees of future events or performance, 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. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to consummate the acquisition described in this press release or to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses, including the acquisition described in this press release, and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, and (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws. 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 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

   

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SOURCE Schwazze

Investors: Joanne Jobin, Investor Relations, [email protected], 647.964.0292; Media: Julie Suntrup, Schwazze, Vice President | Corporate Marketing & Brands, [email protected], 303.371.0387

Release – Eskay Mining Presents New Geophysical Interpretation of its Data and Welcomes Riaz Mirza as Geophysical Advisor in its Quest to Discover Precious Metal-Rich VMS Deposits Across its Consolidated Eskay Project, Golden Triangle, BC

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Research News and Market Data on ESKYF

March 13, 2023

TORONTO, ON / ACCESSWIRE / March 13, 2023 / Eskay Mining Corp. (“Eskay” or the “Company”) (TSX-V:ESK)(OTCQX: ESKYF)(Frankfurt:KN7)(WKN:A0YDPM) is pleased to announce the addition of Mr. Riaz Mirza, M.Sc., as Geophysical Advisor to its exploration team. Mr. Mirza brings a wealth of experience in the application of geophysics for precious- and base-metal exploration in the Golden Triangle where he has been actively engaged in numerous projects over the past decade. Eskay Mining welcomes Mr. Mirza as the newest member of its world-class team of explorers in search of “Eskay Creek V2.0.”

Riaz Mirza, founder of Simcoe Geoscience Limited, a global geophysical service provider, has significant experience exploring a variety of deposit types including volcanogenic massive sulfide (“VMS”) deposits across the Golden Triangle, British Columbia. This experience, as well as Simcoe’s reliance on “next-generation” geophysical data collection and processing, provides Eskay Mining with an entirely new set of tools with which to define new exploration targets for future drill testing.

Mac Balkam, CEO of Eskay Mining, commented: “Riaz and his team have been reviewing our geophysical data from our 100% controlled 602.55 sq km Consolidated Eskay project area with the goal of drawing direct comparisons to that from the original Eskay Creek precious metal-rich VMS deposit. Because VMS deposits typically occur in clusters, drawing direct comparisons of our data to that of our neighbor provides a huge step forward in our quest for discovering ‘Eskay Creek V2.0.’”

John DeDecker, VP of Exploration for Eskay Mining, commented: “Using our large geophysical database, Riaz and his team immediately identified some compelling similarities between the amplitude, texture, distribution and depth of magnetic anomalies associated with the Eskay Creek deposit and multiple areas displaying such patterns across our Consolidated Eskay project. This very distinct magnetic signature associated with the ore bodies at Eskay Creek gives us a powerful tool with which to identify new VMS targets. Combined with our BLEG, rock chip, and soil geochemical data, we now have the ability to undertake much more tightly focused exploration work in 2023.”

Riaz Mirza, Geophysical Advisor to Eskay Mining, noted: “We here at Simcoe Geoscience have already been able to use Eskay Mining’s existing data to illuminate further potential VMS targets. Key magnetic signatures observed at the Eskay Creek deposit are visible in multiple locations across the Consolidated Eskay project telling us we have excellent discovery potential. With this work, Eskay will be able to better use its 2023 exploration budget by targeting its drilling more effectively. We here at Simcoe look forward to teaming up with Eskay’s technical team to strategize our next approaches to exploration including focused mapping, sampling, drilling and perhaps other approaches across Eskay’s large land holdings. We thank Eskay Mining’s for the opportunity to work with their strong technical team as we pursue discovery of ‘Eskay Creek V2.0.’”

Data, Methodology and Interpretation by Simcoe Geoscience

  • A Leapfrog model of mineralization at Eskay Creek was made utilizing publicly available data from the following sources:
    • Drill core assay results for Eskay Creek were obtained from Assessment Report number 18958, as well as news releases available on Skeena Resources Limited’s website.
    • Rock chip assays for Eskay Creek were obtained from Assessment Report number 11160.
    • Drill collar locations reported in Skeena Resources news releases were transformed from mine grid to UTM Zone 9 NAD83.
    • Drill hole assay results in Au equivalent are graphically represented in the image in Figure 1.
  • Airborne SkyTEM and magnetic data gathered in 2021 covering the Consolidated Eskay project and peripheral areas.
  • New analysis of these data show that there is a distinct magnetic signature associated with the Eskay Creek deposit that is clearly evident when a tilt derivative is applied to the magnetic data. This process re-scales the data range allowing for low amplitude magnetic features to be resolved graphically. Mineralized bodies appear sharply resolved as magnetic highs surrounded by distinct magnetic lows giving a bullseye-like appearance to the deposit (Figure 1). Eskay’s geologic team interprets this distinct signature to result from deformation and metamorphism of hydrothermally altered rocks during post-mineralization tectonic events. A three-dimensional model of magnetic susceptibility shows a strong correlation between domains of high magnetic susceptibility with VMS mineralization situated along a surface defined by a magnetic susceptibility of 0.001 SI. Weaker magnetic susceptibility anomalies are associated with the 21A Zone and the 22 Zone.
  • Comparable magnetic anomalies are observed in several areas across Eskay Mining’s Consolidated Eskay property (Figures 2-4, and 6-9). A strong correlation is clearly evident between these anomalies and areas of known VMS mineralization (TV, Jeff, Scarlet-Tarn, Sib-Lulu, C10, and Virginia Lakes) as well as in areas where Au- and Ag-bearing sulfide rock chip samples have been collected along the Harrymel Valley, Eskay Anticline and the Scarlet-Tarn trends. In every case, VMS mineralization encountered by drilling occurs along the margins of the modeled 3D magnetic susceptibility volume as described above at Eskay Creek.
  • Based on observations from magnetic data, a new target named Maroon Cliffs has been identified in the far northeast part of the property (Figures 2-4). Legacy soil sampling on the west side of this anomaly shows strongly elevated Ag and Hg values (Assessment Report number 24155). Data from BLEG surveys conducted in 2020 and 2022 further support the prospectivity of Maroon Cliffs (Figure 5), with two Au BLEG anomalies immediately downstream from this newly identified magnetic anomaly. The presence of the VMS system, CBS Zone, occurring on Tudor Gold’s property to the east along strike from Maroon Cliffs adds further support for the potential of this area. This new target will be a key focus of exploration in 2023.
  • Although the target between Hexagon-Mercury and Jeff North has recently been identified through geologic mapping, and data from Eskay’s 2021 SkyTEM survey, its magnetic signature proves compelling (Figure 6). In addition to a bullseye-like magnetic anomaly visible when the tilt derivative is applied, this target is also associated with several shallow protrusions evident in the 3D magnetic susceptibility model. Such protrusions are distinct at Eskay Creek where they are associated with mineralization. Helipads were constructed in this area in September 2022 to allow access to this rugged area in 2023.
  • The TV-Jeff trend is associated with Eskay Creek-like magnetic anomalies (Figure 7), with the most prominent protrusions in the magnetic susceptibility model corresponding with areas of most intense Au and Ag mineralization. Notably, small protrusions in the magnetic susceptibility model between TV and Jeff correspond with anomalous Au and Ag values from sulfide rock chip samples and widely scattered drill holes. Eskay Mining’s technical team suspects the intensity of magnetic susceptibility anomalies may correlate with the intensity of VMS mineralization. This appears to be the case at TV which is associated with the most pronounced magnetic anomaly in the area (Figure 8). Importantly, this magnetic anomaly continues into un-drill tested areas to the south and west of TV suggesting that VMS mineralization likely extends to these regions. This TV extension will be explored in 2023.
  • The recently identified Scarlet-Tarn trend also appears to be associated with Eskay Creek-like magnetic anomalies (Figure 9). Extensive work in this area in 2021 and 2022 concluded that the Tarn Lake-Scarlet Knob area is underlain by the same rock units hosting the Eskay Creek deposit (e.g., the Eskay Rhyolite). High-grade Au and Ag anomalies associated with intense localized hydrothermal alteration were discovered through rock chip sampling and drilling. It was also determined that stratigraphic up is to the west meaning that the highly prospective Contact Mudstone horizon, host to the Eskay Creek deposit, is likely situated to the west of Tarn Lake. The observed trend of magnetic susceptibility anomalies extending to the west of Tarn Lake indicates this area could indeed host high-grade VMS mineralization similar to that at the Eskay Creek deposit. This area will be a primary focus of Eskay Mining’s 2023 exploration program.
  • All Assessment Reports cited in this news release can be accessed at: https://www2.gov.bc.ca/gov/content/industry/mineral-exploration-mining/british-columbia-geological-survey/assessmentreports

Dr. Quinton Hennigh, P. Geo., a Director of the Company and its technical adviser, a qualified person as defined by National Instrument 43-101, has reviewed and approved the technical contents of this news release.

About Eskay Mining Corp:

Eskay Mining Corp (TSX-V:ESK) is a TSX Venture Exchange listed company, headquartered in Toronto, Ontario. Eskay is an exploration company focused on the exploration and development of precious and base metals along the Eskay rift in a highly prolific region of northwest British Columbia known as the “Golden Triangle,” 70km northwest of Stewart, BC. The Company currently holds mineral tenures in this area comprised of 210 claims (60255 hectares).

All material information on the Company may be found on its website at www.eskaymining.com and on SEDAR at www.sedar.com.

For further information, please contact:

Mac BalkamT: 416 907 4020
President & Chief Executive OfficerE: [email protected]

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

Forward-Looking Statements: This Press Release contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. When used in this document, the words “may”, “would”, “could”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” and similar expressions are intended to identify forward-looking statements. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties. Many factors could cause our actual results to differ materially from the statements made, including those factors discussed in filings made by us with the Canadian securities regulatory authorities. Should one or more of these risks and uncertainties, such as actual results of current exploration programs, the general risks associated with the mining industry, the price of gold and other metals, currency and interest rate fluctuations, increased competition and general economic and market factors, occur or should assumptions underlying the forward looking statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, or expected. We do not intend and do not assume any obligation to update these forward-looking statements, except as required by law. Shareholders are cautioned not to put undue reliance on such forward-looking statements.

SOURCE: Eskay Mining Corp.



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Release – Comtech Secures Multi-Million Dollar Contracts for its ELEVATE Platform to Deliver Enhanced Connectivity in Global Markets

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Research News and Market Data on CMTL

Mar 13, 2023 9:06 AM

MELVILLE, N.Y. –
March 13, 2023–Comtech (NASDAQ: CMTL) recently secured multiple multi-million-dollar contracts for its ELEVATE platform to provide commercial and government customers with satellite cellular backhaul as well as telemetry data and video services over Low Earth Orbit and Geostationary Orbit constellations.

Under the contracts, Comtech will deliver up to 1,000 ELEVATE terminals this year to customers in six countries. Comtech ELEVATE is a platform designed to support multi-orbit constellations as well as the convergence of communications infrastructures.

“Comtech ELEVATE is one of the unique end-to-end technologies and services we are delivering to customers that will usher in a new era of democratized access to global connectivity,” said Ken Peterman, President and CEO, Comtech. “These contracts demonstrate the strong and growing demand for secure, adaptable, and scalable solutions that will be needed to close the digital divide and empower people across the globe with access to new technologies.”

Comtech ELEVATE provides connectivity over satellite as well as access over high capacity wireless networks. ELEVATE’s versatility can support emerging use cases that will enable the convergence of space-based applications in the United States as well as international markets.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

View source version on businesswire.com: https://www.businesswire.com/news/home/20230312005042/en/

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Release – Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights

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Research News and Market Data on TNXP

March 13, 2023 7:00am EDT

Related Documents

Interim Analysis of Registration-Enabling Phase 3 Fibromyalgia Trial of TNX-102 SL Expected Second Quarter 2023; Topline Data Expected Fourth Quarter 2023

Potentially Pivotal Phase 2 Trials of TNX-1900 in Chronic Migraine and TNX-601 ER in Depression Scheduled for Interim Analyses in Fourth Quarter 2023

Potentially Pivotal Phase 2 Fibromyalgia-Type Long COVID Study Enrolling

Cash and Cash Equivalents Totaled Approximately $120.2 Million at December 31, 2022

CHATHAM, N.J., March 13, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2022, and provided an overview of recent operational highlights.

“Our clinical activity is at a high point in the Company’s history, and we believe it is setting the stage for a year of significant accomplishments across an expanded portfolio of novel pharmaceutical candidates designed to serve major unmet medical needs,” said Seth Lederman, M.D., Chief Executive Officer of Tonix.

“We are pleased with the progress of our current Phase 3 program in fibromyalgia, and we are looking forward to the results of a planned interim analysis due next quarter, followed by topline results in the fourth quarter of this year. If successful, we believe it will be the second and final adequate and well-controlled efficacy trial required for filing a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA)”, he added. “Moreover, we believe we have satisfied all the other clinical and non-clinical requirements for an NDA.”

Dr. Lederman added, “Patients and caregivers alike report widespread dissatisfaction with the three currently approved drugs for fibromyalgia – Lyrica®, Cymbalta®, and Savella®, and generic pregabalin and duloxetine – switching back and forth between them, and too often taking off-label products, including addictive opiates. Fibromyalgia affects between six and 12 million adults in the U.S. according to the American Pain Association, and there hasn’t been a new FDA drug approval in the category in more than a dozen years.”

Dr Lederman continued, “Our recently expanded late-stage clinical programs include four potentially pivotal Phase 2 trials. Two are currently enrolling, one in Long COVID and the other in chronic migraine. The two others – one in depression and the other in cocaine intoxication – are due to start enrolling. We expect to initiate enrollment in the depression study by the end of March, followed by the cocaine intoxication study in the second quarter of this year.”

“In summary”, he concluded, “these programs, together with several others in earlier development, represent a diverse portfolio of programs with multiple opportunities for value creation in 2023 and beyond.”

Recent Highlights—Key Product Candidates*

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual tablet): small molecule for the management of fibromyalgia (FM)

  • The first 50% of participants were randomized on December 19, 2022, in the RESILIENT study, a double-blind, randomized, placebo-controlled, potentially pivotal confirmatory Phase 3 study of TNX-102 SL for the management of fibromyalgia. Results from a planned interim analysis are expected in the second quarter of 2023, with topline results expected in the fourth quarter of 2023. A positive topline outcome, together with results from the previous positive Phase 3 RELIEF study, would support submission of an NDA.

TNX-102 SL for the treatment of Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)

  • Enrollment continues in the PREVAIL study, a potentially pivotal Phase 2 study of TNX-102 SL for fibromyalgia-type Long COVID.
  • During a February 2023 virtual event co-hosted by BIO and Solve M.E. titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?”, the Company presented its analysis that the majority of Long COVID patients present with a constellation of symptoms called nociplastic pain that overlap with fibromyalgia, and Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) and that fibromyalgia-type Long COVID appears to be one of several chronic overlapping pain conditions (COPCs) that are related by sharing the neurological process called central sensitization.  

TNX-1900 (intranasal potentiated oxytocin): small peptide for migraine, craniofacial pain, insulin resistance and related disorders, and obesity-associated binge eating disorder

  • In February 2023, Tonix announced that enrollment began in the potentially pivotal Phase 2 PREVENTION study of TNX-1900 for the prevention of migraine headache in chronic migraineurs. The double-blind, placebo-controlled study has a target enrollment of 300 participants at approximately 25 sites across the U.S. Results from a planned interim analysis after the first 50% of enrolled patients have completed the study are expected in the fourth quarter of 2023.
  • In January 2023, data from clinical and nonclinical studies were presented at the 16th Annual Headache Cooperative of the Pacific (HCOP) Winter Conference by collaborator Professor David Yeomans. The oral presentation titled, “Primary vs Secondary Sex Hormones and Migraine,” includes research sponsored by and licensed by Tonix. Preliminary results from a positron emission tomography (PET) study in humans showed that intranasal application of a radioisotope of magnesium-potentiated oxytocin is delivered to the trigeminal ganglia which have known roles in migraine headaches. In addition, preliminary results of data collected from isolated human trigeminal ganglia neurons in vitro show co-expression of oxytocin receptors and calcitonin gene-related peptide (CGRP), which are believed to represent the first observation of oxytocin receptors in human trigeminal ganglia. Furthermore, the presentation highlights data which suggest a sex difference in oxytocin potency.
  • Tonix announced data from an in vitro study describing the impact of oxytocin on isolated human sensory neurons, presented by collaborator Professor David Yeomans at Neuroscience 2022, the annual meeting of the Society for Neuroscience. The poster, titled “In Vitro Impact of Oxytocin on Human Sensory Neurons,” is the first to show that oxytocin receptors are present on human sensory neurons and that inflammation drives expression of oxytocin receptors on these neurons. The results of this study are consistent with data from animal models and provide support for the use of oxytocin for the treatment of pain.
  • An investigator-initiated Phase 2 study of TNX-1900 in obesity-associated binge eating disorder is expected to start enrolling in the second quarter of 2023 directed by principal investigator Professor Elizabeth Lawson at the Massachusetts General Hospital, a teaching hospital of Harvard Medical School.

TNX-601 ER (tianeptine hemioxalate extended-release tablets): a once-daily orally-administered small molecule for the treatment of major depressive disorder (MDD), Posttraumatic Stress Disorder (PTSD), and neurocognitive dysfunction associated with corticosteroid use.

  • Enrollment is expected to initiate in the first quarter of 2023 in the potentially pivotal Phase 2 ‘UPLIFT’ Study for the treatment of MDD. Results from planned interim analysis after the first 50% of enrolled patients have completed the study are expected fourth quarter 2023.
  • TNX-601 ER represents a novel approach to treating depression in the U.S., since the active ingredient tianeptine induces a neuroprotective and resilient phenotype in both neurons and microglia under conditions of stress. In contrast, antidepressants that are marketed in the U.S. act by modulating neurotransmitter levels or receptor binding in the synapse. The Phase 2 UPLIFT study is a double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-601 ER taken orally once-daily for 6 weeks to treat MDD. It is a parallel design study with two arms, a TNX-601 ER 39.4 mg arm and a placebo arm. A total of 300 participants will be randomized in a 1:1 ratio into the two arms across approximately 30 U.S. sites, enrolling adult patients 18-65 years old with a DSM-5 diagnosis of depression and a duration for the current major depressive episode (MDE) of at least 12 weeks. The primary efficacy endpoint is mean change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. Key secondary efficacy endpoints include the Clinical Global Impression of Severity Scale (CGI-S) and the Sheehan Disability Scale (SDS).

TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication

  • Tonix expects to initiate a new, potentially pivotal, Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in the second quarter of 2023, pending agreement with the FDA on trial design.
  • As previously mentioned, in 2022, Tonix received a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support development of TNX-1300.
  • TNX-1300 has been granted Breakthrough Therapy designation by the FDA.

Rare Disease Pipeline

TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)

  • TNX-2900 has been granted Orphan Drug designation from the FDA for the treatment of PWS.
  • As previously mentioned, in 2022, Tonix delivered a presentation titled, “TNX-2900 (Intranasal Oxytocin + Magnesium) in Development for the Treatment of Hyperphagia in Adolescents and Young Adults with Prader-Willi Syndrome” at the World Orphan Drug Congress USA.

Immunology Pipeline

TNX-1500 (anti-CD40L monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.

  • A First-in-Human Phase 1 study is expected to start in the second quarter of 2023 of TNX-1500 for prophylaxis of organ rejection in adult patients receiving a kidney transplant.
  • In February 2023, Tonix announced a research agreement with the University of Maryland, Baltimore, to study and assess the role of TNX-1500 in the prevention of heart xenograft rejection. The genetically engineered pig donors will be provided by the Revivicor Division of United Therapeutics Corporation. Preclinical xenotransplantation studies are expected to support an IND application.
  • Tonix announced a research agreement with Boston Children’s Hospital to study TNX-1500 for the prevention of graft-versus-host diseases (GvHD) after hematopoietic stem cell transplantation (HCT) in animals. HCT from unrelated donors is a component of the treatment protocol for several hematologic malignancies, but GvHD complicates treatment and limits the success of engraftment after HCT.

Infectious Disease Pipeline

TNX-801 (live horsepox virus vaccine for percutaneous administration): vaccine to protect against smallpox and mpox designed as a single-administration vaccine to elicit T cell immunity

  • A Phase 1 study in is expected to start in the second half of 2023.
  • Tonix presented a development update from the Company’s TNX-801 vaccine program in an oral presentation at the World Vaccine and Immunotherapy Congress on December 1, 2022. The oral presentation titled, “Live Virus Smallpox and Monkeypox Vaccine,” describes the history of live virus vaccines and rationale for the development of the Company’s Recombinant Pox Virus (RPV) platform, including TNX-801 to protect against mpox and smallpox. Non-human primates vaccinated with TNX-801 were fully protected with sterilizing immunity from a lethal challenge with intra-tracheal monkeypox.
  • A publication describing the activity of TNX-801 to protect non-human primates against a lethal challenge with intra-tracheal monkeypox was published in the peer-reviewed journal, Viruses (Noyce RS, et al. “Single Dose of Recombinant Chimeric Horsepox Virus (TNX-801) Vaccination Protects Macaques from Lethal Monkeypox Challenge.” Viruses. 2023 Jan 26;15(2):356. doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234.)

*All of Tonix’s product candidates are investigational new drugs or biologics and none have been approved for any indication.

Recent Highlights—Corporate and Other

  • In February 2023, Tonix announced the appointment of R. Newcomb Stillwell to its Board of Directors, effective March 15, 2023. Mr. Stillwell is a retired partner at Ropes & Gray LLP, an international law firm, where he devoted approximately 38 years.
  • In February 2023, Tonix announced that it has exercised an option to obtain an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies for the treatment or prophylaxis of SARS-CoV-2 infection. The licensed monoclonal antibodies were developed as part of a research collaboration and option agreement between Tonix and Columbia University, originally announced in 2020.
  • In February 2023, Tonix announced the acquisition of a preclinical portfolio of next-generation antiviral technology assets from Healion Bio, Inc. (Healion). Healion’s drug portfolio includes a class of broad-spectrum small molecule oral antiviral drug candidates including TNX-3900, formerly known as HB-121, which are cathepsin protease inhibitors, some of which have activity in vitro against SARS-CoV-2.
  • On January 26, 2023, data from Tonix’s research collaboration with The University of Alberta were presented by Tom Hobman, Ph.D., Professor of Cell Biology, University of Alberta, during a presentation at the 2nd Wnt/β-catenin Targeted Drug Development Conference. The oral presentation titled, “Targeting the Wnt/β-catenin pathway as a broad-spectrum antiviral strategy,” includes research sponsored by Tonix Pharmaceuticals focused on the development and testing of Wnt/β-catenin signaling pathway inhibitors as broad-spectrum antivirals against SARS-CoV-2 and other emerging viruses.
  • In January 2023, Tonix announced the publication of a paper entitled, “Development of a rapid image-based high-content imaging screening assay to evaluate therapeutic antibodies against the monkeypox virus,” in the journal Antiviral Research. The publication describes the development and optimization of two high-content image-based assays that were employed to screen for potential therapeutic antibodies against the monkeypox virus using surrogate poxviruses such as vaccinia virus. The article highlights Tonix’s TNX-3400 platform, which includes antibodies to potentially prevent or treat mpox and smallpox. These data represent the first wave of research and development conducted at the Company’s Infectious Disease R&D Center (RDC) in Frederick, Md. (Kota KP, et al., “Development of a rapid image-based high-content imaging screening assay to evaluate therapeutic antibodies against the monkeypox virus.” Antiviral Res. 2023 Feb;210:105513. doi: 10.1016/j.antiviral.2022.105513. Epub 2022 Dec 30. PMID: 36592670; PMCID: PMC9803393.)
  • In January 2023, Tonix announced the appointment of Zeil Rosenberg, M.D., M.P.H. as its new Executive Vice President, Medical.
  • Tonix announced data from its fully human anti-SARS-CoV-2 monoclonal antibody platform in an oral presentation at the World Antiviral Congress 2022. The presentation titled, “Platform for Generating Fully Human anti-SARS-CoV-2 Spike Therapeutic Monoclonal Antibodies” highlights the need for a broad array of monoclonal antibodies which can be scaled up quickly and potentially combined with other monoclonal antibodies to treat or prevent COVID-19. The platform is part of a broader research collaboration and option agreement with scientists at Columbia University designed to fill in important gaps in understanding the detailed immune responses to COVID-19, and to provide a foundation upon which to target vaccines and therapeutics to appropriate individuals by precision medicine.
  • In December 2022, Tonix announced that it has obtained an exclusive license from Curia Global, Inc., a leading contract research, development and manufacturing organization, for the development of three humanized murine monoclonal antibodies for the treatment or prophylaxis of SARS-CoV-2 infection, the cause of COVID-19. Immunocompromised individuals, including organ transplant recipients, are at increased risk of severe COVID-19 and poor clinical outcomes. SARS-CoV-2 has mutated to evade the existing FDA Emergency Use Authorization (EUA)-approved therapeutic monoclonal antibodies.

      Recent Highlights—Financial

As of December 31, 2022, Tonix had $120.2 million of cash and cash equivalents, compared to $178.7 million as of December 31, 2021. Net proceeds from financing activities were approximately $87.8 million for full year 2022, compared to $212.5 million for the full year 2021.

Since January 1, 2023, the Company repurchased 15,700,269 shares of common stock under a $12.5 million share purchase program at prices ranging from $0.44 to $1.38 for a gross aggregate cost of approximately $12.5 million. 

In January 2023, the Board of Directors approved a new $12.5 million share repurchase program. Since January 1, 2023, the Company repurchased 1,000,000 shares of common stock under this share repurchase program at $1.14 for a gross aggregate cost of $1.1 million.

Cash used in operations was approximately $98.1 million for the full year 2022, compared to $75.6 million for the full year 2021. The increase in cash outlays was primarily due to an increase in research and development (R&D) and general and administrative (G&A) activities, described below.

Cash used by investing activities for the years ended December 31, 2022, and 2021 was approximately $48.1 million and $35.3 million, respectively, related to the purchase of property and equipment.

Fourth Quarter 2022 Financial Results

R&D expenses for the fourth quarter 2022 were $24.7 million, compared to $22.3 million for the same period in 2021. The increase is predominately due to increased employee-related, facility and laboratory expenses. We expect R&D expenses to increase during 2023 as we move our clinical development programs forward and invests in our development pipeline.

G&A expenses for the fourth quarter 2022 were $8.1 million, compared to $7.3 million for the same period in 2021. The increase is primarily due to increased employee-related and financial reporting expenses.

Net loss available to common stockholders was $34.1 million, or $0.56 per share, basic and diluted, for the fourth quarter 2022, compared to net loss of $29.6 million, or $2.08 per share, basic and diluted, for the same period in 2021. The basic and diluted weighted average common shares outstanding for the fourth quarter 2022 was 61,379,692 compared to 14,230,897 shares for the same period in 2021.

Full Year 2022 Financial Results

R&D expenses for the full year 2022 were $81.9 million, compared to $68.8 million for the same period in 2021. The increase is predominately due to increased employee-related, facility and laboratory expenses. We expect R&D expenses to increase during 2023 as we move our clinical development programs forward and invest in our development pipeline.

G&A expenses for the full year 2022 were $30.2 million, compared to $23.5 million for the same period in 2021. The increase is primarily due to increased employee-related and financial reporting expenses.

Net loss available to common stockholders was $116.9 million, or $3.27 per share, basic and diluted, for the full year 2022, compared to net loss of $92.3 million, or $8.10 per share, basic and diluted, for the same period in 2021. The basic and diluted weighted average common shares outstanding for full year 2022 was 35,739,057 compared to 11,387,308 shares for the same period in 2021.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is being studied in a potential pivotal Phase 2 study that initiated enrollment in the first quarter of 2023 and for which interim data is expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and mpox, TNX-801; a next-generation vaccine to prevent COVID-19, TNX-1850; a platform to make fully human and murine monoclonal antibodies to treat COVID-19, TNX-3600 and TNX-4100, respectively; and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800; and a class of broad-spectrum small molecule oral antivirals, TNX-3900. TNX-801, Tonix’s vaccine in development to prevent smallpox and mpox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in the second half of 2023.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

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

Forward Looking Statements

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

Contacts

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

Olipriya Das, Ph.D. (media)
Russo Partners
[email protected]
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
[email protected]
(443) 213-0505

Release – Sierra Metals Announces Refinancing Agreement and Ongoing Discussions To Allow For Flexibility On Debt Repayment For 2023

Posted on by [email protected]

Research News and Market Data on SMT

MARCH 13, 2023

Company to Host Investor Conference Call for 2022 Q4 and Full-Year Financial Results on March 29, 2023

TORONTO–(BUSINESS WIRE)– Sierra Metals Inc. (TSX: SMT) (“Sierra Metals” or the “Company”) announced today that the Company, Banco de Credito del Peru and Banco Santander S.A. (together, the “Lenders”) are engaged in advanced discussions on terms to refinance $18,750,000 of the $25,000,000 principal debt repayment obligations that are due in 2023 under the Company’s senior secured credit facility. All figures in this news release are stated in U.S. dollars.

The parties intend to formalize the refinancing contract prior to the due date of the second quarterly principal installment on June 8, 2023, subject to, among other things, the completion of due diligence.

The Lenders have agreed to provide a bridge loan of $6,250,000 to refinance the first quarter 2023 amortization payment, due on March 8, 2023, while the refinancing contract for the balance of the 2023 payments is being finalized.

2022 Financial Results

Sierra Metals also announced a revised date of March 28, 2023 for the expected filing of its financial and operating results for the year ended December 31, 2022. The Company’s senior management team will host a conference call on Wednesday, March 29, 2023, at 11:00 AM EDT to discuss the results. The call may be accessed as follows.

Via Webcast:

A live audio webcast of the meeting will be available on the Company’s website: https://events.q4inc.com/attendee/111210337

The webcast, along with presentation slides, will be archived for 180 days on www.sierrametals.com.

Via phone:

For those who prefer to listen by phone, dial-in instructions are below. To ensure your participation, please call approximately five minutes prior to the scheduled start time of the call.

Canada dial-in number (Toll Free): 1 833 950 0062
Canada dial-in number (Local): 1 226 828 7575
US dial-in number (Toll Free): 1 844 200 6205
US dial-in number (Local): 1 646 904 5544
All other locations: +1 929 526 1599

Access code: 077974

Press *1 to ask a question, *2 to withdraw your question, or *0 for operator assistance.

About Sierra Metals

Sierra Metals is a diversified Canadian mining company with Green Metal exposure including copper production and base metal production with precious metals byproduct credits, focused on the production and development of its Yauricocha Mine in Peru, and Bolivar and Cusi Mines in Mexico. The Company is focused on increasing production volume and growing mineral resources. The Company also has large land packages at all three mines with several prospective regional targets providing longer-term exploration upside and mineral resource growth potential. For further information regarding Sierra Metals, please visit www.sierrametals.com.

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Forward-Looking Statements

This press release contains forward-looking information within the meaning of Canadian and United States securities legislation. Forward-looking information relates to future events or the anticipated performance of Sierra and reflect management’s expectations or beliefs regarding such future events and anticipated performance based on an assumed set of economic conditions and courses of action. In certain cases, statements that contain forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “believes” or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, or “will be taken”, “occur” or “be achieved” or the negative of these words or comparable terminology. Forward-looking statements include those relating to formalizing the refinancing contract and the timeline related thereto and the timing of senior management’s conference call to discuss the Company’s financial and operating results for the year ended December 31, 2022. By its very nature forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual performance of Sierra to be materially different from any anticipated performance expressed or implied by such forward-looking information.

Forward-looking information is subject to a variety of risks and uncertainties, which could cause actual events or results to differ from those reflected in the forward-looking information, including, without limitation, the risks described under the heading “Risk Factors” in the Company’s annual information form dated March 16, 2022 for its fiscal year ended December 31, 2021 and other risks identified in the Company’s filings with Canadian securities regulators and the SEC, which filings are available at www.sedar.com and www.sec.gov, respectively.

The risk factors referred to above are not an exhaustive list of the factors that may affect any of the Company’s forward-looking information. Forward-looking information includes statements about the future and is inherently uncertain, and the Company’s actual achievements or other future events or conditions may differ materially from those reflected in the forward-looking information due to a variety of risks, uncertainties and other factors. The Company’s statements containing forward-looking information are based on the beliefs, expectations, and opinions of management on the date the statements are made, and the Company does not assume any obligation to update such forward-looking information if circumstances or management’s beliefs, expectations or opinions should change, other than as required by applicable law. For the reasons set forth above, one should not place undue reliance on forward-looking information.

Investor Relations
Sierra Metals Inc.
Tel: +1 (416) 366-7777
Email: [email protected]

Source: Sierra Metals Inc.

Release – Largo Reports Fourth Quarter and Full Year 2022 Financial Results; Highlights Recent Strength in the Vanadium Market and Progress on its Two-Pillar Strategy as a Tier 1 Vanadium Supplier and Emerging Clean Energy Battery Producer

Posted on by [email protected]

Research News and Market Data on LGO

March 09, 2023

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All dollar amounts expressed are in thousands of U.S. dollars unless otherwise indicated.

Q4 & Full Year 2022 Highlights

  • Revenues of $47.5 million in Q4 2022, 6% below Q4 2021; Revenues per pound sold1 of $7.77 in Q4 2022, largely in line with $7.88 recognized in Q4 2021
  • Operating costs of $44.5 million in Q4 2022 vs. $37.7 million in Q4 2021, and cash operating costs excluding royalties per pound1 of V2O5 equivalent sold of $5.15 in Q4 2022 vs. $3.68 in Q4 2021
  • Net loss of $15.6 million in Q4 2022 vs. net income of $1.0 million in Q4 2021; Basic loss per share of $0.24 in Q4 2022 vs. basic earnings per share of $0.01 in Q4 2021
  • In Q4 2022, the Company’s net loss included approximately $6.3 million of non-recurring expenditures
  • Revenues of $229.3 million in 2022, a 16% increase over 2021; Revenues per pound sold1 of $9.38 in 2022, a 19% increase over 2021
  • Operating costs of $169.7 million in 2022 vs. $133.0 million in 2021, and cash operating costs excluding royalties per pound1 of V2O5 equivalent sold of $4.57 in 2022 vs. $3.37 in 2021; 2% above upper range of revised 2022 guidance for cash operating costs excluding royalties per pound1
  • Net loss of $2.2 million in 2022 vs. net income of $22.6 million in 2021; Basic loss per share of $0.03 in 2022 vs. basic earnings per share of $0.35 in 2021
  • In 2022, the Company’s net loss included approximately $15.0 million of non-recurring expenditures
  • V2O5 production of 2,004 tonnes in Q4 2022 vs. 2,003 tonnes in Q4 2021; Annual V2O5 production of 10,436 tonnes in 2022 vs. 10,319 tonnes in 2021 and 6% below lower range of revised production guidance
  • Quarterly sales of 2,772 tonnes of V2O5 equivalent (inclusive of 118 tonnes of purchased material) in Q4 2022 vs. 2,899 tonnes in Q4 2021; Annual V2O5 equivalent sales of 11,091 (inclusive of 1,057 tonnes of purchased material) tonnes in 2022 vs. 11,393 tonnes in 2021 and within revised sales guidance of 11,000 – 12,000 tonnes

Vanadium Price Update2

  • The average benchmark price per pound of V2O5 in Europe was $8.25 in Q4 2022, being largely in line with the average of $8.23 seen in Q3 2022 and $8.30 in Q4 2021; The average benchmark price as of March 3, 2023 was $10.78, a 44% increase from the lows of 2022
  • The average benchmark price per kg of ferrovanadium (“FeV”) in Europe was $33.35 in Q4 2022, a 3% decrease from the average of $32.29 seen in Q4 2021; The average FeV benchmark price as of March 3, 2023 was $40.88, a 30% increase from the lows of 2022

TORONTO–(BUSINESS WIRE)– Largo Inc. (“Largo” or the “Company“) (TSX: LGO) (NASDAQ: LGO) today released financial and operating results for the three and twelve months ended December 31, 2022. The Company reported annual vanadium pentoxide (“V2O5”) equivalent sales of 11,091 tonnes at a cash operating cost excluding royalties per pound1 sold of $4.58. Revenues in 2022 increased 16% over 2021 to $229.3 million mainly due to a strengthening of vanadium prices in the year.

Daniel Tellechea, Interim CEO and Director of Largo, stated: “For Largo, 2022 was a challenging year, which led to an underperformance on both production and cost metrics, particularly in Q4 2023 with the mining disruption caused by record rainfall at our mine, cost inflation of key raw materials and sizeable non-recurring expenditures. Although we continue to navigate an inflationary environment, we anticipate delivering and capitalizing on a 10% increase in production for 2023 over 2022, particularly with the recent strengthening of vanadium prices.” He continued: “This recent increase is due in part to increased demand from the energy storage sector, especially in China, where new vanadium redox flow battery (“VRFB”) deployments totaling around 2 GWh or approximately 10% of global vanadium output are planned for the next 12-24 months.Importantly, the VRFB sector accounted for the second largest source of vanadium demand outside of the steel sector in Q3 2022, according to Vanitec, a global vanadium organization. Other key markets including steel, aerospace, and chemical have also shown considerable demand growth in recent months.”

He continued: “As for growth plans this year, Largo’s ilmenite project remains on track and is expected to generate a new source of revenue for the Company. We anticipate providing guidance on ilmenite production for 2023 once commissioning of the plant has been completed. We continue to make progress on the installation of our first VRFB in Spain and our negotiations toward the formation of a joint venture with Ansaldo Green Tech (“Ansaldo”) for the deployment of VRFBs in the Europe, Middle East and Africa power generation markets. Lastly, safety and sustainability remain key priorities for Largo and we are pleased to be recently ranked in the top quartile of our peer group as measured by certain ESG rating agencies for 2022.”

Q4 & Full Year 2022 Financial Results Overview

  • During 2022, the Company recognized revenues of $229.3 million from sales of 11,091 tonnes of V2O5 equivalent (2021 – 11,393 tonnes). This represents a 16% increase in revenues over 2021 ($198.3 million) mainly due to higher vanadium prices in the year, particularly with revenues recognized in Q2 2022. During Q4 2022, the Company recognized revenues of $47.5 million (Q4 2021 – $50.3 million) from sales of 2,772 tonnes of V2O5 equivalent (Q4 2021 – 2,899 tonnes).
  • Operating costs of $169.7 million in 2022 (2021 – $133.0 million) include direct mine and production costs of $94.5 million (2021 – $75.1 million), conversion costs of $8.1 million (2021 – $9.3 million), product acquisition costs of $24.4 million (2021 –$9.7 million), royalties of $10.4 million (2021 – $8.9 million), distribution costs of $9.2 million (2021 – $5.3 million), inventory write-down of $2.3 million (2021 – $3.2 million), depreciation and amortization of $20.9 million (2021 – $21.5 million) and iron ore costs of $1.0 million (2021 – $0.05 million), partially offset by insurance proceeds of $1.0 million (2021 – $nil).
  • Operating costs of $44.5 million in Q4 2022 (Q4 2021 – $37.7) include direct mine and production costs of $28.4 million (Q4 2021 – $21.4 million), conversion costs of $2.2 million (Q4 2021 – $2.6 million), product acquisition costs of $3.8 million (Q4 2021 – $1.0 million), royalties of $2.1 million (Q4 2021 – $2.3 million), distribution costs of $2.3 million (Q4 2021 – $1.5 million), inventory write-down of $0.4 million (Q4 2021 – $3.2 million), depreciation and amortization of $6.0 million (Q4 2021 – $5.8 million) and iron ore costs of $0.02 million (Q4 2021 – $nil), partially offset by insurance proceeds of $1.0 million (Q4 2021 – $nil).
    • The increases in direct mine and production costs are attributable to a decrease in the global recovery5, cost increases in critical consumables, including heavy fuel oil (“HFO”) and ammonium sulfate, as well as increased consumption of these critical consumables and sodium carbonate. Costs were further impacted by the Company’s mining contractor transition in Q3 2022 and corrective maintenance in the plant throughout the year. Higher costs of production in the current and previous periods in the year related to shutdowns caused by abnormally high rainfall during Q4 2022, while corrective maintenance continued to impact operating costs as a result of the time between production and sales.
  • Cash operating costs excluding royalties per pound1 of V2O5 equivalent soldwere $4.57 in 2022, compared with $3.37 in 2021. Cash operating costs excluding royalties per pound1 sold were $5.15 in Q4 2022, compared with $3.68 in Q4 2021. The increase seen in Q4 2022 and 2022 compared with Q4 2021 and 2021 is largely due to the impacts noted previously, in addition to produced V2O5 equivalent sold having decreased in 2022 as compared with 2021, with 10,034 tonnes sold versus 10,864 tonnes.
  • Professional, consulting and management fees were $25.3 million in 2022, compared with $17.9 million in 2021. Professional, consulting and management fees were $5.7 million in Q4 2022, compared with $5.6 million in Q4 2021. For 2022, the increase is primarily attributable to costs incurred earlier in the year in connection with LCE, which was not fully operational earlier in 2021 and transaction and listing related costs incurred by Largo Physical Vanadium Corp. (“LPV”) in connection with the completion of its qualifying transaction.
  • Other general and administrative expenses were $14.3 million in 2022, compared with $6.4 million in 2021. Other general and administrative expenses were $3.5 million in Q4 2022, compared with $2.3 million in Q4 2021. For 2022, the increase is primarily due to an increase in provisions as well as costs incurred in Q4 2022 in connection with LPV, and in Largo Clean Energy Corp. (“LCE”) which has scaled up activities throughout 2022. The increase in provisions relates to a supply agreement for the Maracás Menchen Mine which was filed with Brazilian courts in October 2014. The ruling requires the Company to pay amounts due, plus interest and legal fees.
  • Technology start-up costs were $12.7 million in 2022 (2021 – $3.8 million) and $8.2 million in Q4 2022 (Q4 2021 – 3.1 million). This includes a full write-down of battery components inventory at LCE of $6.4 million (Q4 2022 and 2022) (Q4 2021 and 2021 – $nil) to their expected net realizable value. Technology start-up costs relate to LCE’s activities related to ramping up its operations for the deployment of the VCHARGE VRFB system and the titanium project in Brazil.
  • Finance costs in Q4 2022 increased from Q4 2021 by 118% (or $0.4 million), which is attributable to increased debt, as well as the initial financing fees on the Company’s new debt facilities.
  • For 2022, cash provided by financing activities increased from cash used in financing activities in 2021 by $33.3 million. The movement is primarily attributable to the receipt of debt of $55.0 million and cash received from the sale of non-controlling interest of $7.3 million (2021 – $nil), partially offset by the repayment of debt of $30.0 million (2021 – $24.8 million) and share repurchases of $6.0 million. Cash provided by financing activities in Q4 2022 increased from cash used in financing activities in Q4 2021 by $24.1 million. This movement was primarily due to the receipt of new debt of $40.0 million, partially offset by a repayment of debt of $15.0 million.
  • Cash used in investing activities in Q4 2022 of $26.8 million is an increase of $19.8 million from the $7.0 million seen in Q4 2021. This movement was primarily driven by the purchase of vanadium assets and continued work on the ilmenite project. For 2022, the increase from 2021 was $32.7 million. Expenditures in 2022 primarily relate to the ilmenite project, mining equipment, costs relating to a software implementation and cash outflows for purchased product vanadium assets.

Additional Company Updates

  • Q4 and Full Year 2022 Operational Results: Production of 2,004 tonnes of V2O5 in Q4 2022 was in line with the 2,003 tonnes of V2O5 produced in Q4 2021, primarily due to reduced massive ore inventory arising from the transition in mining contractors in Q3 2022 and due to unusually heavy rainfall in December 2022. In Q4 2022, the Company produced 839 V2O5 equivalent tonnes of high purity products, including 650 tonnes of high purity V2O5 and 189 tonnes of high purity vanadium trioxide (“V2O3”). This represented 42% of the total quarterly production. In 2022, the Company produced 1,801 V2O5 equivalent tonnes of high purity products, including 1,368 tonnes of high purity V2O5 and 433 tonnes of high purity V2O3. In Q4 2022, 326,552 tonnes of ore were mined with an effective grade4 of 0.96% of V2O5. The ore mined in Q4 2022 was 18% higher than in Q4 2021. The Company produced 90,797 tonnes of concentrate with an effective grade4 of 2.94%. The global recovery5 achieved in Q4 2022 was 74.7%, a decrease of 1.7% from the 76.0% achieved in Q4 2021 and 7.4% lower than the 80.7% achieved in Q3 2022. The global recovery5 in October 2022 was 75.0%, with 67.8% achieved in November 2022 and 80.8% achieved in December 2022.
  • Continued Focus on ESG in 2022: The Company continued to improve its overall Environmental, Social and Governance (“ESG”) performance and public disclosures in 2022. This is reflected in additional improved ratings and scores, most notably its S&P Global Corporate Sustainability Assessment (“CSA”) rating having improved approximately 38%, placing the Company in the top quartile of its mining peer group for 2022. This improvement was largely driven by updates to Largo’s governance of ESG, including new policies, ESG oversight at the Board level and climate-related disclosures, as well as improved responses related to the Company’s on-going environmental compliance in Brazil. The Company expects to issue its 2022 sustainability report in late Q2 2023.
  • Largo Clean Energy Recent Developments: During Q4 2022, LCE continued to make significant progress on the delivery of the Enel Green Power España (“EGPE”) contract, which remains a priority focus. Substantially all the hardware is either in transit to or is in Spain awaiting installation. The Company shipped the remaining six of 12 electrolyte storage containers in early 2023 and the Field Service team has been on site in Q1 2023 and work is ongoing to install and interconnect the AC and DC power systems. Provisional acceptance, which requires the completion of as-build drawings, manuals, final punch-list items, and operational testing by EGPE, is expected to be completed by the end of May 2023. Additionally, LCE and Ansaldo continue to focus on the formation of a joint venture for the manufacturing and commercial deployment of VRFBs in the European, African and Middle East power generation markets. The Company’s previously announced memorandum of understanding (“MOU”) has been extended to March 31, 2023, to allow for the negotiation and entering into a joint venture and other ancillary agreements. Ansaldo and LCE continue to develop a business path for the joint venture to service the European markets with Long Duration Energy Storage (“LDES”).
  • Ilmenite Concentration Plant Progress: The Company progressed with the construction of its ilmenite concentration plant at its Maracás Menchen Mine in Q4 2022. The Company received all required flotation structures and is finalizing the building of its desliming, flotation, filtration, warehouse and pipe rack structures ands expects commissioning of the plant to be completed in Q2 2023.
  • January and February 2023 Production and Sales: Subsequent to Q4 2022, the Company produced 354 tonnes of V2O5 in January and 843 tonnes in February. The Company also sold 1,080 tonnes of V2O5 equivalent (including 68 tonnes of purchased material) in January 2023 and 750 tonnes (including 11 tonnes of purchased material) in February. Production in January and February was largely impacted by low ore availability in due to the heavy rains at the mine site and planned maintenance of the kiln for its refractory refurbishment, with sales in February being impacted by a delay in sales recognition. The Company expects to remain within its quarterly production and sales guidance for Q1 2023.
  • Largo Physical Vanadium Update: LPV’s net assets are now over 90% held in physical vanadium products and near-term delivery commitments (approximately 2.9 million lbs of V2O5 equivalent). The launch of LPV in September 2022 coincided with lower vanadium prices, which allowed LPV to purchase vanadium units at favorable market prices. LPV’s net asset value (“NAV”) is now C$2.56 per share or 28% above the closing share price of C$2.00 per share on March 8, 2023. LPV believes its NAV to share price discount offers current and new LPV investors an attractive investment case and closing this disconnect is now LPV’s key focus. LPV management are working on a broad marketing and communication campaign to raise awareness of its investment proposal.
  • Director Resignation: Following the Company’s previously announced leadership change on February 16, 2023, Mr. Paulo Misk has resigned from his position as a Director of the Company effective March 7, 2023.

Annual 2022 Webcast and Conference Call Information

The Company will host a webcast and conference call on Friday, March 10, 2023, at 1:00 p.m. ET, to discuss its fourth quarter and annual 2022 results and progress.

Details of the webcast and conference call are listed below:

To join the conference call without operator assistance, you may register and enter your phone number at https://bit.ly/3Yho3fJ to receive an instant automated call back.

You can also dial direct to be entered to the call by an Operator via dial-in details below.

A playback recording will be available on the Company’s website for a period of 60-days following the conference call.

The information provided within this release should be read in conjunction with Largo’s annual consolidated financial statements for the years ended December 31, 2022 and 2021 and its management’s discussion and analysis for the year ended December 31, 2022 which are available on our website at www.largoinc.com or on the Company’s respective profiles at www.sedar.com and www.sec.gov.

About Largo

Largo has a long and successful history as one of the world’s preferred vanadium companies through the supply of its VPURETM and VPURE+TM products, which are sourced from one of the world’s highest-grade vanadium deposits at the Company’s Maracás Menchen Mine in Brazil. Aiming to enhance value creation at Largo, the Company will be implementing a titanium dioxide pigment plant using feedstock sourced from its existing operations in addition to advancing its U.S.-based clean energy division with its VCHARGE vanadium batteries. Largo’s VCHARGE vanadium batteries contain a variety of innovations, enabling an efficient, safe and ESG-aligned long duration solution that is fully recyclable at the end of its 25+ year lifespan. Producing some of the world’s highest quality vanadium, Largo’s strategic business plan is based on two pillars: 1.) leading vanadium supplier with an outlined growth plan and 2.) U.S.-based energy storage business support a low carbon future.

Largo’s common shares trade on the Nasdaq Stock Market and on the Toronto Stock Exchange under the symbol “LGO”. For more information, please visit www.largoinc.com.

Cautionary Statement Regarding Forward-looking Information:

This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian and United States securities legislation. Forward ‐ looking information in this press release includes, but is not limited to, statements with respect to the timing and amount of estimated future production and sales; the future price of commodities; costs of future activities and operations, including, without limitation, the effect of inflation and exchange rates; the effect of unforeseen equipment maintenance or repairs on production; timing and cost related to the build-out of the ilmenite plant; the ability to produce vanadium trioxide according to customer specifications; the extent of capital and operating expenditures; the impact of global delays and related price increases on the Company’s global supply chain and future sales of vanadium products. Forward ‐ looking information in this press release also includes, but is not limited to, statements with respect to our ability to build, finance and successfully operate a VRFB business, the projected timing and cost of the completion of the EGPE project; our ability to protect and develop our technology, our ability to maintain our IP, the competitiveness of our product in an evolving market, our ability to market, sell and deliver our VCHARGE batteries on specification and at a competitive price, our ability to successfully deploy our VCHARGE batteries in foreign jurisdictions; our ability to negotiate and enter into a joint venture with Ansaldo Green Tech on terms satisfactory to the Company and the success of such joint venture; the receipt of necessary governmental permits and approvals on a timely basis, our ability to secure the required resources to build and deploy our VCHARGE batteries, and the adoption of VRFB technology generally in the market.

The following are some of the assumptions upon which forward-looking information is based: that general business and economic conditions will not change in a material adverse manner; demand for, and stable or improving price of V2O5 and other vanadium commodities; receipt of regulatory and governmental approvals, permits and renewals in a timely manner; that the Company will not experience any material accident, labour dispute or failure of plant or equipment or other material disruption in the Company’s operations at the Maracás Menchen Mine or relating to Largo Clean Energy, specially in respect of the installation and commissioning of the EGPE project; the availability of financing for operations and development; the ability to mitigate the impact of continuing heavy rainfall; the Company’s ability to procure equipment and operating supplies in sufficient quantities and on a timely basis; that the estimates of the resources and reserves at the Maracás Menchen Mine are within reasonable bounds of accuracy (including with respect to size, grade and recovery and the operational and price assumptions on which such estimates are based); the competitiveness of the Company’s VRFB technology; the ability to obtain funding through government grants and awards for the Green Energy sector, the accuracy of cost estimates and assumptions on future variations of VCHARGE battery system design, that the Company’s current plans for ilmenite and VRFBs can be achieved; the Company’s “two-pillar” business strategy will be successful; the Company’s sales and trading arrangements will not be affected by the evolving sanctions against Russia; and the Company’s ability to attract and retain skilled personnel and directors; the ability of management to execute strategic goals.

Forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved”. All information contained in this news release, other than statements of current and historical fact, is forward looking information. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Largo or Largo Clean Energy to be materially different from those expressed or implied by such forward-looking statements, including but not limited to those risks described in the annual information form of Largo and in its public documents filed on www.sedar.com and available on www.sec.gov from time to time. Forward-looking statements are based on the opinions and estimates of management as of the date such statements are made. Although management of Largo has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Largo does not undertake to update any forward-looking statements, except in accordance with applicable securities laws. Readers should also review the risks and uncertainties sections of Largo’s annual and interim MD&As which also apply.

Trademarks are owned by Largo Inc.

Non-GAAP Measures

The financial statements and related notes of Largo have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board. This press release contains non-GAAP financial measures and non-GAAP ratios, which are not standardized financial measures under IFRS, and might not be comparable to similar financial measures disclosed by other issuers. These measures are intended to provide additional information and should not be considered in isolation or as a substitute for measures of performance prepared in accordance with IFRS.

Revenues Per Pound

The Company’s press release refers to revenues per pound sold, V 2 O 5 revenues per pound of V 2 O 5 sold, V 2 O 3 revenues per pound of V 2 O 3 sold and FeV revenues per kg of FeV sold, which are non-GAAP financial measures that are used to provide investors with information about a key measure used by management to monitor performance of the Company.

These measures, along with cash operating costs, are considered to be key indicators of the Company’s ability to generate operating earnings and cash flow from its Maracás Menchen Mine and sales activities. These measures differ from measures determined in accordance with IFRS, and are not necessarily indicative of net earnings or cash flow from operating activities as determined under IFRS.

The following table provides a reconciliation of revenues per pound sold, V 2 O 5 revenues per pound of V 2 O 5 sold, V 2 O 3 revenues per pound of V 2 O 3 sold and FeV revenues per kg of FeV sold to revenues and the revenue information presented in note 18 as per the 2022 annual consolidated financial statements.

Cash Operating Costs and Cash Operating Costs Excluding Royalties

The Company’s press release refers to cash operating costs per pound and cash operating costs excluding royalties per pound, which are non-GAAP ratios based on cash operating costs and cash operating costs excluding royalties, which are non-GAAP financial measures, in order to provide investors with information about a key measure used by management to monitor performance. This information is used to assess how well the Maracás Menchen Mine is performing compared to plan and prior periods, and also to assess its overall effectiveness and efficiency.

Cash operating costs includes mine site operating costs such as mining costs, plant and maintenance costs, sustainability costs, mine and plant administration costs, royalties and sales, general and administrative costs (all for the Mine properties segment), but excludes depreciation and amortization, share-based payments, foreign exchange gains or losses, commissions, reclamation, capital expenditures and exploration and evaluation costs. Operating costs not attributable to the Mine properties segment are also excluded, including conversion costs, product acquisition costs, distribution costs and inventory write-downs.

Cash operating costs excluding royalties is calculated as cash operating costs less royalties.

Cash operating costs per pound and cash operating costs excluding royalties per pound are obtained by dividing cash operating costs and cash operating costs excluding royalties, respectively, by the pounds of vanadium equivalent sold that were produced by the Maracás Menchen Mine.

Cash operating costs, cash operating costs excluding royalties, cash operating costs per pound and cash operating costs excluding royalties per pound, along with revenues, are considered to be key indicators of the Company’s ability to generate operating earnings and cash flow from its Maracás Menchen Mine. These measures differ from measures determined in accordance with IFRS, and are not necessarily indicative of net earnings or cash flow from operating activities as determined under IFRS.

The following table provides a reconciliation of cash operating costs and cash operating costs excluding royalties, cash operating costs per pound and cash operating costs excluding royalties per pound for the Maracás Menchen Mine to operating costs as per the 2022 annual consolidated financial statements.

Investor Relations
Alex Guthrie
Senior Manager, External Relations
+1.416.861.9778
[email protected]

Source: Largo Inc.

Release – Information Services Group Announces Record Fourth-Quarter and Full-Year 2022 Results

Posted on by [email protected]

Research News and Market Data on III

3/9/2023

  • Reports fourth-quarter GAAP revenues of $74 million,an all-time quarterly high, exceeding guidance and including a negative FX impact of $3.2 million
  • Reports fourth-quarter net income of $4 million, GAAP EPS of $0.09 and adjusted EPS of $0.13, all fourth-quarter records
  • Reports record fourth-quarter adjusted EBITDA of $11 million, exceeding guidance
  • Achieves record full-year results: GAAP revenues of $286 million, up 8% in constant currency; operating income of $29 million, up 17%; net income of $20 million, up 27%; adjusted net income of $27 million, up 18%, GAAP EPS of $0.39, up 30%; adjusted EPS of $0.53, up 20%; adjusted EBITDA of $43 million, up 11%
  • Declares first-quarter dividend of $0.04 per share, payable March 31, 2023, to shareholders of record as of March 20, 2023
  • As previously announced, amends credit agreement to include more favorable terms, an extended maturity date, elimination of $4.3 million of mandatory annual principal payments, and conversion to an all-revolving credit facility with $140 million of borrowing capacity
  • Sets first-quarter guidance: revenues between $73 million and $75 million and adjusted EBITDA between $10 million and $11 million

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced record financial results for the fourth quarter and full year ended December 31, 2022.

“ISG delivered our best quarterly and full-year performance in our 17-year history—on every key financial metric,” said Michael P. Connors, chairman and CEO. “Fourth-quarter revenue and profitability reached record highs, led by double-digit operating growth in the Americas and Europe as client demand for efficiency and optimization escalates. Our suite of client solutions in digital transformation, cost optimization, research, workplace and governance services, supported by our successful ISG NEXT operating model, is a winning combination.”

Some clients, especially those in industries and geographies facing the toughest market conditions, are turning to ISG to help them optimize their IT and operating environments, Connors said. “Clients trust ISG for our unmatched combination of data, insights, expertise, tools and solutions to help streamline their technology and operating environments, reinvest in continuous transformation and get the most out of the collaboration between people and technology,” he said.

Fourth-Quarter 2022 Results

Reported revenues for the fourth quarter were a record $74.2 million, up 7 percent from $69.6 million in the prior year, and up 11 percent in constant currency. Currency translation negatively impacted reported revenues by $3.2 million versus the prior year. Reported revenues were $43.6 million in the Americas, up 12 percent; $23.9 million in Europe, up 1 percent on a reported basis and up 12 percent in constant currency; and $6.7 million in Asia Pacific, down 4 percent on a reported basis and up 5 percent in constant currency, all versus the prior year.

ISG reported fourth-quarter operating income of $7.2 million, flat versus the prior year. Reported fourth-quarter net income was a record $4.3 million, up 20 percent, compared with net income of $3.6 million in the prior year. Fully diluted earnings per share was a record $0.09, compared with $0.07 per fully diluted share in the prior year. Net income margin (calculated by dividing net income by reported revenues) increased to 5.8 percent, from 5.1 percent in the fourth quarter of 2021.

Adjusted net income (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) for the fourth quarter was $6.5 million, or a record $0.13 per share on a fully diluted basis, compared with adjusted net income of $5.1 million, or $0.10 per share on a fully diluted basis, in the prior year’s fourth quarter.

Fourth-quarter adjusted EBITDA (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) was a record $11.1 million, up 9 percent from the prior-year fourth quarter. Adjusted EBITDA margin (a non-GAAP measure calculated by dividing adjusted EBITDA by reported revenues) was 15 percent, up 33 basis points from the prior year.

Full-Year 2022 Results

Reported revenues for the full-year were a record $286.3 million, up 3 percent versus the prior-year, and up 8 percent in constant currency. Currency translation negatively impacted reported revenues by $12.7 million versus 2021. Reported revenues were $166.7 million in the Americas, up 4 percent; $89.9 million in Europe, flat on a reported basis and up 12 percent in constant currency; and $29.7 million in Asia Pacific, up 8 percent on a reported basis and up 16 percent in constant currency, all versus the prior year.

ISG reported record full-year operating income of $29.5 million, up 17 percent from $25.3 million in the prior year. The firm also reported record net income and fully diluted earnings per share of $19.7 million and $0.39, respectively, versus net income of $15.5 million and earnings per share of $0.30 in the prior year. Net income margin (calculated by dividing net income by reported revenues) increased to 6.9 percent, from 5.6 percent in the same period last year.

Adjusted net income (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) for the full year was a record $26.9 million, or $0.53 per share on a fully diluted basis, compared with adjusted net income of $22.9 million, or $0.44 per share on a fully diluted basis, in the prior year.

Full-year adjusted EBITDA (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) reached a record $43.3 million, up 11 percent from the prior year. Adjusted EBITDA margin (a non-GAAP measure calculated by dividing adjusted EBITDA by reported revenues) was a record 15 percent, up more than 110 basis points from the prior year.

Other Financial and Operating Highlights

ISG generated $6.6 million of cash from operations in the fourth quarter, compared with $2.5 million in the prior year, and $11.1 million for the full year. The firm’s cash balance totaled $30.6 million at December 31, 2022, up from $19.7 million at September 30, 2022.

During the fourth quarter, ISG paid dividends of $2.0 million, paid down $1.1 million of debt and drew down $9.0 million on its revolving credit agreement with the funds used for the acquisition of Change 4 Growth and for general operating purposes. As of December 31, 2022, ISG had $79.2 million in debt outstanding, compared with $74.5 million at the end of the fourth quarter last year. The firm’s gross-debt-to-adjusted-EBITDA ratio (a non-GAAP measure calculated by dividing outstanding debt by adjusted EBITDA) was 1.8 times, a record low for year end.

“Our strong operating results allowed us to return $23.6 million of capital to our shareholders in the form of dividends and share repurchases in 2022,” Connors said. “It also allowed us to amend our existing credit agreement, converting it to an all-revolver facility, with more favorable terms and an extended maturity date.”

Amended Credit Agreement

As previously announced, on February 22, 2023, ISG successfully amended the credit agreement that the firm originally entered into on March 10, 2020. The amended agreement provides $140 million of borrowing capacity at more favorable terms, converts the previous term and revolving loan into an all-revolving credit facility, eliminates $4.3 million of mandatory annual principal payments under the previous agreement, and extends the maturity date of the previous agreement by three years, to February 2028.

2023 First-Quarter Revenue and Adjusted EBITDA Guidance

“For the first quarter, ISG is targeting revenues of between $73 million and $75 million – including 200 basis points of FX headwinds – and adjusted EBITDA of between $10 million and $11 million. We will continue to monitor the macroeconomic environment, including the impact of FX, inflation and other factors, and adjust our business plans accordingly.”

Quarterly Dividend

The ISG Board of Directors declared a first-quarter dividend of $0.04 per share, payable on March 31, 2023, to shareholders of record as of March 20, 2023.

Conference Call

ISG has scheduled a call for 9 a.m., U.S. Eastern Time, Friday, March 10, 2023, to discuss the company’s fourth-quarter results. The call can be accessed by dialing +1 833-470-1428; or, for international callers, by dialing +1 929-526-1599. The access code is 356636. A recording of the conference call will be accessible on ISG’s website (www.isg-one.com) for approximately four weeks following the call.

Forward-Looking Statements

This communication contains “forward-looking statements” which represent the current expectations and beliefs of management of ISG concerning future events and their potential effects. Statements contained herein including words such as “anticipate,” “believe,” “contemplate,” “plan,” “estimate,” “target,” “expect,” “intend,” “will,” “continue,” “should,” “may,” and other similar expressions, are “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not guarantees of future results and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated. Those risks relate to inherent business, economic and competitive uncertainties and contingencies relating to the businesses of ISG and its subsidiaries including without limitation: (1) failure to secure new engagements or loss of important clients; (2) ability to hire and retain enough qualified employees to support operations; (3) ability to maintain or increase billing and utilization rates; (4) management of growth; (5) success of expansion internationally; (6) competition; (7) ability to move the product mix into higher margin businesses; (8) general political and social conditions such as war, political unrest and terrorism; (9) healthcare and benefit cost management; (10) ability to protect ISG and its subsidiaries’ intellectual property or data and the intellectual property or data of others; (11) currency fluctuations and exchange rate adjustments; (12) ability to successfully consummate or integrate strategic acquisitions; (13) outbreaks of diseases, including coronavirus, or similar public health threats or fear of such an event; and (14) engagements may be terminated, delayed or reduced in scope by clients. Certain of these and other applicable risks, cautionary statements and factors that could cause actual results to differ from ISG’s forward-looking statements are included in ISG’s filings with the U.S. Securities and Exchange Commission. ISG undertakes no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.

Non-GAAP Financial Measures

ISG reports all financial information required in accordance with U.S. generally accepted accounting principles (GAAP). In this release, ISG has presented both GAAP financial results as well as non-GAAP information for the three and twelve months ended December 31, 2022, and December 31, 2021. ISG believes that evaluating its ongoing operating results will be enhanced if it discloses certain non-GAAP information. These non-GAAP financial measures exclude non-cash and certain other special charges that many investors believe may obscure the user’s overall understanding of ISG’s current financial performance and the Company’s prospects for the future. ISG believes that these non-GAAP measures provide useful information to investors because they improve the comparability of the financial results between periods and provide for greater transparency of key measures used to evaluate the Company’s performance.

ISG provides adjusted EBITDA (defined as net income plus interest, taxes, depreciation and amortization, foreign currency transaction gains/losses, non-cash stock compensation, interest accretion associated with contingent consideration, acquisition-related costs, and severance, integration and other expense), adjusted net income (defined as net income plus amortization of intangible assets, non-cash stock compensation, foreign currency transaction gains/losses, interest accretion associated with contingent consideration, acquisition-related costs, and severance, integration and other expense, on a tax-adjusted basis), adjusted net income per diluted share, adjusted EBITDA margin, gross-debt-to-adjusted-EBITDA ratio and selected financial data on a constant currency basis which are non-GAAP measures that the Company believes provide useful information to both management and investors by excluding certain expenses and financial implications of foreign currency translations, which management believes are not indicative of ISG’s core operations. These non-GAAP measures are used by ISG to evaluate the Company’s business strategies and management’s performance.

We evaluate our results of operations on both an as reported and a constant currency basis. The constant currency presentation, which is a non-GAAP financial measure, excludes the impact of year-over-year fluctuations in foreign currency exchange rates. We believe providing constant currency information provides valuable supplemental information regarding our results of operations, thereby facilitating period-to-period comparisons of our business performance and is consistent with how management evaluates the Company’s performance. We calculate constant currency percentages by converting our current and prior-periods local currency financial results using the same point in time exchange rates and then compare the adjusted current and prior period results. This calculation may differ from similarly titled measures used by others and, accordingly, the constant currency presentation is not meant to be a substitution for recorded amounts presented in conformity with GAAP, nor should such amounts be considered in isolation.

Management believes this information facilitates comparison of underlying results over time. Non-GAAP financial measures, when presented, are reconciled to the most closely applicable GAAP measure. Non-GAAP measures are provided as additional information and should not be considered in isolation or as a substitute for results prepared in accordance with GAAP. A reconciliation of the forward-looking non-GAAP estimates contained herein to the corresponding GAAP measures is not being provided, due to the unreasonable efforts required to prepare it.

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

Source: Information Services Group, Inc.

Release – Onconova Therapeutics to Provide Corporate Update And Announce Fourth Quarter And Full Year 2022 Financial Results On March 16, 2023

Posted on by [email protected]

Research News and Market Data on ONTX


Mar 09, 2023

PDF Version

Company to host conference call and webcast at 4:30 p.m. ET on Thursday, March 16, 2023

NEWTOWN, Pa., March 09, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company intends to release its fourth quarter and full year 2022 financial results on Thursday, March 16, 2023. Management plans to host a conference call and live webcast at 4:30 p.m. ET on the same day to discuss these results and provide an update on its pipeline programs.

Conference Call and Webcast Information

Interested parties who wish to participate in the conference call may do so by dialing (800) 715-9871 for domestic and (646) 307-1963 for international callers and using conference ID 3097517.

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose escalation and expansion studies. These trials are currently underway in the United States and China. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also planning a combination trial of narazaciclib with estrogen blockade in advanced endometrial cancer, as well as its clinical study in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa.

For more information, please visit www.onconova.com.

Forward Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
[email protected]

Release – Comtech Announces Results for its Second Quarter of Fiscal 2023 and Updates Third Quarter Fiscal 2023 Financial Targets

Posted on by [email protected]

Research News and Market Data on CMTL

Mar 9, 2023 4:05 PM

MELVILLE, N.Y. –
March 9, 2023– Comtech (NASDAQ: CMTL) today announced its second quarter fiscal 2023 financial results and updated its third quarter fiscal 2023 financial targets in a letter to shareholders which is now posted to the Investor Relations section of Comtech’s website.

Investors are invited to access the second quarter fiscal 2023 shareholder letter at its web site at comtech.com/investor-relations/. A copy of the letter will also be filed with the Securities and Exchange Commission in a Form 8-K.

Comtech also intends to host a previously scheduled earnings conference call at 5:00PM ET today that is intended to be briefer but provide more time for questions and discussion. Individuals can access the conference call by dialing (800) 225-9448 (domestic) or (203) 518-9708 (international) and using the conference I.D. of “Comtech.” A replay of the conference call will be available for two weeks by dialing (800) 839-3516 or (402) 220-7238. A live webcast of the call is also available at comtech.com/investor-relations/.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward- looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

View source version on businesswire.com: https://www.businesswire.com/news/home/20230309005635/en/

Investor Relations

Robert Samuels

[email protected]

Release – Entravision Communications Corporation Reports Fourth Quarter and Full Year 2022 Results

Posted on by [email protected]

Research News and Market Data on EVC

03/09/2023

SANTA MONICA, Calif.–(BUSINESS WIRE)– Entravision Communications Corporation (NYSE: EVC), a leading global advertising solutions, media and technology company, today announced financial results for the three- and twelve-month periods ended December 31, 2022.

Fourth Quarter and Full Year 2022 Highlights

  • Record fourth quarter and annual revenue
  • Record fourth quarter and annual consolidated adjusted EBITDA
  • Record political advertising revenue compared to prior election cycles, including presidential
  • Net loss attributable to common stockholders of $1.6 million in the fourth quarter compared to net income attributable to common stockholders of $3.9 million in the prior-year quarter
  • Net income attributable to common stockholders for the full year down 38% compared to the prior-year
  • Consolidated adjusted EBITDA up 11% and 17% compared to the prior-year quarter and full year, respectively
  • Operating cash flow down 93% and up 21% compared to the prior-year quarter and full year, respectively
  • Free cash flow down 37% and 20% compared to the prior-year quarter and full year, respectively
  • Quarterly cash dividend increase to $0.05 per share

“We are pleased with our 2022 performance, which marks a record year for Entravision for revenue and consolidated adjusted EBITDA,” said Entravision Interim Chief Executive Officer and Chief Financial Officer, Chris Young. “Our results demonstrate the resiliency and strength of our business through challenging macro conditions, and the successful execution of our strategic plan to create a leading global advertising solutions, media and technology company. We have enhanced our digital segment organically, as well as through strategic partnerships, geographic expansion and accretive acquisitions to bolster our suite of digital services in the large and growing advertising industry. Our complementary non-digital businesses, while a smaller percentage of our revenue portfolio, continue to be an important contributor to our growth. We will continue to leverage our tools, reach, technology and world-class team to meet our clients’ evolving needs and deliver enhanced shareholder value.”

Paul Zevnik, Interim Chair and co-founder said, “The Entravision team mourns the sudden and tragic loss of our late CEO, founder and dear friend, Walter Ulloa. Walter passed unexpectedly on the last day of the most successful year in the company’s history. Since we founded Entravision in 1996, we have developed a clear vision to build a leading global advertising solutions, media and technology company serving diverse demographics with diverse media. Through Walter’s leadership and with the support of a strong leadership team and dedicated entrepreneurs across each of Entravision’s business platforms, we have achieved tremendous growth and transformed the Company’s geographical breadth and media portfolio. Most importantly, we created a company that is a great place to work with a focus on engagement, trust, open communications, community service and involvement, and long-lasting relationships with our key partners. I miss our friend dearly, and the Board is committed to working with management to advance Walter’s vision and execute on our roadmap to deliver enhanced value for our stakeholders and partners.”

Quarterly Cash Dividend

As previously announced, the Company’s Board of Directors approved a quarterly cash dividend to shareholders of $0.05 per share on the Company’s Class A and Class U common stock, in an aggregate amount of approximately $4.4 million. This is double the Company’s previous quarterly dividend of $0.025 in 2022 and returns the dividend to its pre-pandemic level. The quarterly dividend will be payable on March 31, 2023 to shareholders of record as of the close of business on March 16, 2023, and the common stock will trade ex-dividend on March 15, 2023. The Company currently anticipates that future cash dividends will be paid on a quarterly basis; however, any decision to pay future cash dividends will be subject to approval by the Board.

Non-GAAP Financial Measures

This press release contains certain non-GAAP financial measures as defined by SEC Regulation G. The GAAP financial measure most directly comparable to each of these non-GAAP financial measures, and a table reconciling each of these non-GAAP financial measures to its most directly comparable GAAP financial measure is included beginning on page 10.

Net revenue in the fourth quarter of 2022 totaled $296.3 million, up 27% from $233.9 million in the prior-year period. Of the overall increase, approximately $52.6 million was attributable to our digital segment and was primarily due to advertising revenue growth from our digital commercial partnerships business. In addition, the increase in net revenue in our digital segment was due to our investments in variable interest entities in 2022, which did not contribute to our results of operations in the comparable prior-year period. In addition, of the overall increase, approximately $5.6 million was attributable to our television segment, primarily due to an increase in political advertising revenue, partially offset by decreases in local and national advertising revenue. These decreases were mainly attributed to the expiration of our Univision and UniMás network affiliation agreements in Orlando, Tampa and Washington, D.C. on December 31, 2021. Additionally, of the overall increase, approximately $4.2 million was attributable to our audio segment, primarily due to increases in political advertising revenue and national advertising revenue, partially offset by a decrease in local advertising revenue.

Cost of revenue in the fourth quarter of 2022 totaled $192.0 million, up 29% from $148.4 million in the prior-year period. The increase was primarily due to increased cost of revenue related to advertising revenue growth from our digital commercial partnerships business, and due to our investments in variable interest entities in 2022, which did not contribute to our results of operations in the comparable prior-year period.

Operating expenses in the fourth quarter of 2022 totaled $57.2 million, up 19% from $48.1 million in the prior-year period. Of the overall increase, approximately $7.0 million was attributable to our digital segment and was primarily due to an increase in expenses associated with the increase in digital advertising revenue, an increase in salary expense and non-cash stock-based compensation, and an increase due to our investments in variable interest entities in 2022, which did not contribute to our results of operations in the comparable prior-year period. In addition, of the overall increase in operating expenses, approximately $1.1 million was attributable to our television segment primarily due to an increase in rent expense, an increase in bad debt expense and an increase in non-cash stock-based compensation, partially offset by a decrease in expenses associated with the decrease in local and national advertising revenue. Additionally, of the overall increase in operating expenses, approximately $1.0 million was attributable to our audio segment primarily due to an increase in expenses associated with the increase in national advertising revenue and an increase in rent expense.

Corporate expenses in the fourth quarter of 2022 totaled $22.6 million, up 101% from $11.2 million in the prior-year period. The increase was primarily due to $8.1 million of severance related expense incurred upon the passing of our late Chief Executive Officer, and due to increases in non-cash stock-based compensation and an increase in salaries.

Net revenue for the year ended December 31, 2022 totaled $956.2 million, up 26% from $760.2 million in the prior-year period. Of the overall increase, approximately $191.8 million was attributable to our digital segment and was primarily due to advertising revenue growth from our digital commercial partnerships business. In addition, the increase in net revenue in our digital segment was due to our investments in variable interest entities in 2022 and our acquisitions in 2021, which did not contribute to our results of operations for the full prior-year period. In addition, of the overall increase, approximately $6.4 million was attributable to our audio segment primarily due to increases in political advertising revenue and local advertising revenue, partially offset by a decrease in national advertising revenue. The overall increase was partially offset by a decrease of approximately $2.1 million attributable to our television segment, primarily due to decreases in local and national advertising revenue, a decrease in spectrum usage rights revenue, and a decrease in retransmission consent revenue. These decreases were mainly attributed to the expiration of our Univision and UniMás network affiliation agreements in Orlando, Tampa and Washington, D.C. on December 31, 2021. The decrease in our television segment revenue was partially offset by an increase in political advertising revenue.

Cost of revenue for the year ended December 31, 2022 totaled $623.9 million, up 34% from $466.5 million in the prior-year period. The increase was primarily due to increased cost of revenue related to advertising revenue growth from our digital commercial partnerships business, and due to our investments in variable interest entities in 2022 and our acquisitions in 2021, which did not contribute to our results of operations for the full prior-year period.

Operating expenses for the year ended December 31, 2022 totaled $197.8 million, up 14% from $173.0 million in the prior-year period. Of the overall increase, approximately $22.5 million was attributable to our digital segment and was primarily due to an increase in expenses associated with the increase in digital advertising revenue, an increase in salary expense and non-cash stock-based compensation, and an increase due to our investments in variable interest entities in 2022 and our acquisitions in 2021, which did not contribute to our results of operations for the full prior-year period. In addition, of the overall increase in operating expenses, approximately $0.6 million was attributable to our television segment primarily due to an increase in rent expense, an increase in bad debt expense and an increase in non-cash stock-based compensation, partially offset by a decrease in expenses associated with the decrease in local and national advertising revenue. Additionally, of the overall increase in operating expenses, approximately $1.7 million was attributable to our audio segment primarily due to an increase in expenses associated with the increase in local advertising revenue and an increase in rent expense.

Corporate expenses for the year ended December 31, 2022 totaled $49.4 million, up 50% from $33.0 million in the prior-year period. The increase was primarily due to $8.1 million of severance related expense incurred upon the passing of our late Chief Executive Officer, and due to increases in non-cash stock-based compensation and an increase in salaries.

Balance Sheet and Related Metrics

Cash and marketable securities as of December 31, 2022 totaled approximately $155.2 million. Total debt under the Company’s credit agreement was $209.3 million. Net of $75 million of cash and marketable securities, total leverage as defined in the Company’s credit agreement was 1.3 times as of December 31, 2022. Net of total cash and marketable securities, total leverage was 0.5 times.

Notice of Conference Call

Entravision Communications Corporation will hold a conference call to discuss its fourth quarter and full year 2022 results on Thursday, March 9, 2023 at 5:00 p.m. Eastern Time. To access the conference call, please dial (844) 836-8739 (U.S.) or (412) 317-5440 (Int’l) ten minutes prior to the start time and reference Conference ID number 10176187. The call will also be available via live webcast on the investor relations portion of the Company’s website located at www.entravision.com.

About Entravision Communications Corporation

Entravision is a leading global advertising, media and ad-tech solutions company connecting brands to consumers by representing top platforms and publishers. Our dynamic portfolio includes digital, television and audio offerings. Digital, our largest revenue segment, is comprised of four business units: our digital sales representation business; Smadex, our programmatic ad purchasing platform; our branding and mobile performance solutions business; and our digital audio business. Through our digital sales representation business, we connect global media companies such as Meta, Twitter, TikTok and Spotify with advertisers in primarily emerging growth markets worldwide. Smadex is our mobile-first demand side platform, enabling advertisers to execute performance campaigns using machine learning. We also offer a branding and mobile performance solutions business, which provides managed services to advertisers looking to connect with global consumers, primarily on mobile devices, and our digital audio business provides digital audio advertising solutions for advertisers in the Americas. In addition to digital, Entravision has 49 television stations and is the largest affiliate group of the Univision and UniMás television networks. Entravision also manages 45 primarily Spanish-language radio stations that feature nationally recognized, Emmy award-winning talent. Shares of Entravision Class A Common Stock trade on the NYSE under ticker: EVC. Learn more about our offerings at entravision.com or connect with us on LinkedIn and Facebook.

Forward-Looking Statements

This press release contains certain forward-looking statements. These forward-looking statements, which are included in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, may involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results and performance in future periods to be materially different from any future results or performance suggested by the forward-looking statements in this press release. Although the Company believes the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that actual results will not differ materially from these expectations, and the Company disclaims any duty to update any forward-looking statements made by the Company. From time to time, these risks, uncertainties and other factors are discussed in the Company’s filings with the Securities and Exchange Commission.

Christopher T. Young
Interim Chief Executive Officer,
and Chief Financial Officer and Treasurer
Entravision Communications Corporation
310-447-3870

Kimberly Esterkin
ADDO Investor Relations
310-829-5400
evc@kesterkinaddo-com

Source: Entravision Communications Corporation