MIAMI, May 08, 2023 (GLOBE NEWSWIRE) — Motorsport Games Inc. (NASDAQ: MSGM) (“Motorsport Games” or the “Company”), a leading racing game developer, publisher and esports ecosystem provider of official motorsport racing series throughout the world, will report its financial results for the first fiscal quarter of 2023 on Thursday, May 11, 2023, after market close. Management will host a conference call and webcast on the same day at 6:00 p.m. ET to discuss the results.
Participants may access the live webcast on the Company’s investor relations website at https://ir.motorsportgames.com under “Events.” The call may also be accessed by dialing 1 (844) 826-3033 from the U.S., or by dialing 1 (412) 317-5185 internationally.
About Motorsport Games: Motorsport Games, a Motorsport Network company, is a leading racing game developer, publisher and esports ecosystem provider of official motorsport racing series throughout the world. Combining innovative and engaging video games with exciting esports competitions and content for racing fans and gamers, Motorsport Games strives to make the joy of racing accessible to everyone. The Company is the officially licensed video game developer and publisher for iconic motorsport racing series across PC, PlayStation, Xbox, Nintendo Switch and mobile, including NASCAR, INDYCAR, 24 Hours of Le Mans and the British Touring Car Championship (“BTCC”), as well as the industry leading rFactor 2 and KartKraft simulations. rFactor 2 also serves as the official sim racing platform of Formula E, while also powering F1 Arcade through a partnership with Kindred Concepts. Motorsport Games is an award-winning esports partner of choice for 24 Hours of Le Mans, Formula E, BTCC, the FIA World Rallycross Championship and the eNASCAR Heat Pro League, among others. Motorsport Games is building a virtual racing ecosystem where each product drives excitement, every esports event is an adventure and every story inspires.
Website and Social Media Disclosure:
Investors and others should note that we announce material financial information to our investors using our investor relations website (ir.motorsportgames.com), SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media and blogs, to communicate with our investors and the public about our company and our products. It is possible that the information we post on our websites, social media and blogs could be deemed to be material information. Therefore, we encourage investors, the media and others interested in our company to review the information we post on the websites, social media channels and blogs, including the following (which list we will update from time to time on our investor relations website):
NEWTOWN, Pa., May 08, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced an upcoming presentation at the International Society of Investigative Dermatology (ISID) International Epidermolysis Bullosa Symposium, which is being held in Osaka, Japan through May 9, 2023.
The presentation will take place on May 9, 2023, at 1:00 p.m. Japan Standard Time. During the presentation, Onconova and the principal investigators will provide an overview of its investigator-sponsored clinical program evaluating rigosertib monotherapy in squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC). The Company previously announced that both of the program’s evaluable participants achieved a complete clinical response of all cancerous skin lesions. Onconova plans to review these findings with regulators to determine the most expeditious path toward approval for rigosertib in RDEB-associated SCC.
Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “RDEB-associated SCC is an ultra-rare disease with a tragically poor prognosis. The most common cause of death for patients with RDEB is the development of metastatic SCC, driven by the overexpression of PLK-1. Our investigator-sponsored clinical program has produced very promising results based on the complete resolution of the SCCs in patients with RDEB treated to date, suggesting rigosertib can address a pressing unmet need in this indication and may have therapeutic potential in other more common SCCs driven by PLK-1. We look forward to discussing these results with the clinical and scientific community at the upcoming ISID symposium.”
A copy of the slides from the oral presentation will be available on the “Scientific Presentations” section of the Onconova website following the conclusion of the symposium.
About RDEB-associated SCC
RDEB is caused by insufficient expression of type VII collagen protein, which is responsible for anchoring the skin’s inner layer to its outer layer. This leads to extreme skin fragility as well as chronic blistering and wound formation with recurrent infections in RDEB patients, many of whom go on to develop metastatic squamous cell carcinoma driven by overexpression of polo like kinase 1 (PLK-1). RDEB-associated SCC tumors show a highly aggressive and early metastasizing course that makes them the primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by ages 45 and 55, respectively1,2. RDEB-associated SCC can appear in pediatric patients or in young adults. Currently available treatments such as targeted therapies and conventional chemo- and/or radiotherapy have demonstrated limited response rates and poor durability in RDEB-associated SCC1,3.
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 evaluating opportunities for potential clinical studies 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 (RDEB-associated SCC).
Fine et al. J Am Acad Dermatol. 2009 Feb; 60(2):203-11. doi: 10.1016/j.jaad.2008.09.035.
Stratigos et al. Eur J Cancer. 2020 Mar;128:83-102. doi: 10.1016/j.ejca.2020.01.008.
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.
Prioritizing Late-Stage Clinical CNS Programs in Fibromyalgia, Depression, Migraine, and Cocaine Intoxication
Topline Results Expected in Fourth Quarter 2023 for Potentially Confirmatory Phase 3 Trial of TNX-102 SL for Fibromyalgia
Potentially Pivotal Phase 2 Trial of TNX-601 ER for Major Depressive Disorder (MDD) Enrolling; TNX-601 ER Represents an Innovative Approach for MDD through Restoration of Neuroplasticity and Neurogenesis
Cash and Cash Equivalents of Approximately $72.0 Million at March 31, 2023
CHATHAM, N.J., May 08, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2023, and provided an overview of recent operational highlights.
“With much achieved already, we expect 2023 will continue to serve as an important milestone year for Tonix,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “The prioritization of key programs in our pipeline highlights our commitment to helping bring relief and value to patients suffering from diseases with limited or insufficient therapeutic options. We are pleased with the enrollment in our current RESILIENT Phase 3 study for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in fibromyalgia. We are looking forward to topline results from the trial 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). Moreover, we believe we have satisfied all the other clinical and non-clinical requirements for an NDA submission. In addition, we are excited to have initiated enrollment in the potentially pivotal UPLIFT Phase 2 study of TNX-601 ER (tianeptine hemioxalate extended release tablets) for major depressive disorder (MDD). TNX-601 ER represents a novel approach to treating depression in the U.S., since the active ingredient tianeptine restores neuroplasticity and neurogenesis rather than modulating neurotransmitter levels and activity.”
Recent Highlights—Key Product Candidates*
Central Nervous System (CNS) Pipeline
TNX-102 SL: small molecule for the management of fibromyalgia (FM)
In March 2023 at the 5th International Congress on Controversies in Fibromyalgia, the Company presented positive efficacy and safety data from Phase 3 RELIEF Study of TNX-102 SL for the management of fibromyalgia. Titled “Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results from the Randomized, Placebo Controlled RELIEF Trial”, the presentation displayed the data that TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia. In addition, TNX-102 SL was well tolerated with the most common adverse event associated with active treatment being oral numbness or hypoaesthesia, an administration site reaction that is typically transient, was never rated as severe, and led to only one discontinuation.
The Company recently announced new plans to eliminate the interim analysis to streamline the ongoing Phase 3 RESILIENT trial and to provide topline data in the fourth quarter of 2023. Target enrollment for the TNX-102 SL fibromyalgia study remains approximately 470 participants.
TNX-102 SL for the treatment of Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)
In April 2023, enrollment of 63 participants was completed in the PREVAIL study, a Phase 2 study of TNX-102 SL for fibromyalgia-type Long COVID.
Topline results from the PREVAIL Phase 2 trial are expected in the third quarter of 2023.
In February 2023 at a 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 including multisite pain, fatigue, sleep disorders and cognitive dysfunction or brain fog. These symptoms overlap with fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). Fibromyalgia-type Long COVID, like fibromyalgia and CFS/ME, appears to be one of several chronic overlapping pain conditions that have in common the neurological process called central sensitization.
TNX-601 ER: a once-daily orally-administered small molecule for the treatment of MDD, Posttraumatic Stress Disorder (PTSD), neurocognitive dysfunction associated with corticosteroid use and potentially Alzheimer’s disease
In March 2023, enrollment was initiated in the potentially pivotal Phase 2 ‘UPLIFT’ Study for the treatment of MDD. Results from a planned interim analysis are expected to be released in the fourth quarter of 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. 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. The primary efficacy endpoint is mean change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
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, enrollment began in the 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 150 participants at approximately 25 sites across the U.S, with topline results 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 and licensed by Tonix. Preliminary results from a positron emission tomography study in humans showed that intranasal delivery 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, 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 expects to initiate a potentially pivotal, Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in the third quarter of 2023.
As previously disclosed, 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.
In March 2023, 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 Rare Disease Innovation and Partnership Summit. The presentation displayed data showing the enhancing effects of magnesium (Mg2+) on the activation of oxytocin receptors. The Mg2+ enhanced formulation of intranasal oxytocin is the basis for TNX-2900, in development to treat hyperphagia, or pathological over-eating, in children and young adult patients with PWS.
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.
In May 2023, the IND for prevention of organ rejection in patients receiving a kidney transplant was cleared by FDA. A First-in-Human Phase 1 study is expected to initiate in the third quarter of 2023.The first indication for TNX-1500 will be prophylaxis of organ rejection in adult patients receiving a kidney transplant, but multiple additional indications are possible, including autoimmune diseases.
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. In April 2023, the Company announced the online publication of two papers in the American Journal of Transplantation by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital (MGH) in collaboration with Tonix Pharmaceuticals1,2. The publications include data demonstrating that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. To date, there has not been a humanized anti-CD40L antibody that can effectively prevent transplant rejections with an acceptable level of safety.
Infectious Disease Pipeline
TNX-801 (live horsepox virus vaccine for percutaneous administration): vaccine to protect against smallpox and monkeypox (mpox) designed as a single-administration vaccine to elicit T cell immunity.
As previously announced, a Phase 1 study is expected to start in the second half of 2023.
In January 2023, the Company appointed Zeil Rosenberg, M.D., M.P.H., as Executive Vice President, Medical for Infectious Disease programs. Dr. Rosenberg is responsible for leading the Company’s clinical development efforts for vaccines, including TNX-801.
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, Viruses3.
*All of Tonix’s product candidates are investigational new drugs or biologics and none has been approved for any indication.
1Lassiter, G., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate renal allograft survival. American Journal of Transplantation. https://doi.org/10.1016/j.ajt.2023.03.022
2Miura, S., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate cardiac allograft survival. American Journal of Transplantation. https://doi.org/10.1016/j.ajt.2023.03.025
3Noyce RS, et al. (2023). Single Dose of Recombinant Chimeric Horsepox Virus (TNX-801) Vaccination Protects Macaques from Lethal Monkeypox Challenge. Viruses. 15(2):356. doi: 10.3390/v15020356
Recent Highlights—Corporate and Other
In April 2023, Tonix announced it is reallocating resources and cash to streamline its pipeline and focus on its mid- and late-stage clinical programs within its core CNS portfolio. The pipeline realignment prioritizes key near-term value drivers, reduces investment in several longer-term programs, particularly COVID-19-related studies, and delays the start of a PTSD study in Kenya.
Recent Highlights—Financial
As of March 31, 2023, Tonix had $72.0 million of cash and cash equivalents, compared to $120.2 million as of December 31, 2022. Net cash used by financing activities was approximately $11.5 million for first quarter 2023, compared to net cash provided by financing activities of $13.1 million for the same period in 2022.
On April 8, 2020, the Company entered into a sales agreement (the “Sales Agreement”) with AGP of up to $320.0 million in at-the-market offerings (“ATM”) sales. During the quarter ended March 31, 2023, the Company sold approximately 3.2 million shares of common stock under the Sales Agreement, for net proceeds of approximately $2.0 million. Subsequent to March 31, 2023, the Company has sold 0.9 million shares of common stock under the Sales Agreement, for net proceeds of approximately $0.5 million.
In January 1, 2023, the Company repurchased 16,700,269 shares of common stock under its share repurchase programs at an average price per share of $0.82 for a gross aggregate cost of approximately $13.6 million.
Cash used in operations was approximately $32.9 million for the first quarter ended March 31, 2023, compared to $31.0 million for the first quarter ended March 31, 2022.
Cash used by investing activities for the first quarter ended March 31, 2023, and 2022 was approximately $3.8 million and $20.2 million, respectively, related to the purchase of property and equipment.
First Quarter 2023 Financial Results
R&D expenses for the first quarter 2023 were $26.5 million, compared to $18.4 million for the same period in 2022. As planned, R&D expenses will be increasing during 2023 as we move our clinical development programs forward and invest in our development pipeline.
G&A expenses for the first quarter 2023 were $7.4 million, compared to $8.0 million for the same period in 2022. The decrease is primarily due to decreased employee-related and financial reporting expenses.
Net loss was $33.0 million, or $0.52 per share, basic and diluted, for the first quarter 2023, compared to net loss of $26.4 million, or $1.61 per share, basic and diluted, for the same period in 2022. The basic and diluted weighted average common shares outstanding for the first quarter 2023 was 63,352,898 compared to 16,445,010 shares for the same period in 2022.
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 topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation 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 third 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 rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third 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 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.
*All of Tonix’s product candidates are investigational new drugs or biologics and none has 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.
TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In Thousands, Except Share and Per Share Amounts) (unaudited)
Three Months Ended March 31,
2023
2022
COSTS AND EXPENSES:
Research and development
$
26,511
$
18,422
General and administrative
7,391
8,014
33,902
26,436
Operating loss
(33,902
)
(26,436
)
Interest income
897
19
Net loss
$
(33,005
)
$
(26,417
)
Net loss per common share, basic and diluted
$
(0.52
)
$
(1.61
)
Weighted average common shares outstanding, basic and diluted
63,352,898
16,445,010
See the accompanying notes to the condensed consolidated financial statements
1The condensed consolidated balance sheet for the year ended December 31, 2022 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
The Company sold 300,000 pounds of uranium at a gross margin of 58%, 79,344 pounds of vanadium at a gross margin of 37%, and the Alta Mesa property for a total gain of $116.45 million; Working capital increased, total assets increased, and total liabilities decreased.
LAKEWOOD, Colo., May 5, 2023 /CNW/ – Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR) (“Energy Fuels” or the “Company”) today reported its financial results for the quarter ended March 31, 2023. The Company’s Quarterly Report on Form 10-Q has been filed with the U.S. Securities and Exchange Commission (“SEC“) and may be viewed on the Electronic Document Gathering and Retrieval System (“EDGAR“) at www.sec.gov/edgar.shtml, on the System for Electronic Document Analysis and Retrieval (“SEDAR“) at www.sedar.com, and on the Company’s website at www.energyfuels.com. Unless noted otherwise, all dollar amounts are in U.S. dollars.
Financial Highlights:
As of March 31, 2023, the Company had a robust balance sheet with $143.61 million of working capital (versus $116.97 million at December 31, 2022), including $43.83 million of cash and cash equivalents, $60.44 million of marketable securities, $38.00 million of inventory, and no debt. At current commodity prices, the Company’s product inventory has a value of $52.53 million;
During the three months ended March 31, 2023, the Company realized net income of $114.26 million, or $0.72 per share, primarily due to: (i) a net gain of $116.45 million on the sale of the Company’s Alta Mesa in situ recovery (“ISR“) project in Texas; (ii) a net gain of $10.76 million on the sale of 300,000 pounds of uranium (“U3O8“) to the U.S. Uranium program; (iii) a net gain of $0.32 million on the sale of 79,344 pounds of vanadium (“V2O5“); (iv) increased expenses associated with preparing four (4) of our uranium mines for production; (v) expenses associated with developing commercial rare earth element (“REE“) separation capabilities; and (vi) a non-cash mark-to-market loss on investments accounted for at fair value of $2.96 million.
The Company realized a total gross margin of 57% on its product sales during Q1-2023, including 58% on its uranium sale and 37% on its vanadium sales.
At March 31, 2023, the Company’s total assets and current assets increased by 37% and 10%, respectively, and total liabilities and current liabilities decreased by 44% and 72%, respectively, as compared to December 31, 2022.
As of March 31, 2023, the Company held 847,000 pounds of finished U3O8, 906,000 pounds of finished V2O5, and 250 metric tons (“MT“) of finished high-purity, partially separated mixed REE carbonate (“RE Carbonate“) in inventory.
The Company holds an additional 394,000 lbs. of U3O8 as raw materials and work-in-progress inventory, along with 1 – 3 million pounds of solubilized V2O5 in tailings solutions that could be recovered in the future.
Uranium Highlights:
During Q1-2023, the Company completed the sale of 300,000 pounds of U3O8 to the U.S. Uranium Reserve realizing total gross proceeds of $18.47 million, or $61.57 per pound of U3O8. This sale resulted in a gross margin of approximately $35.85 per pound of uranium, or a gross margin of 58%.
During 2023, the Company expects to sell an additional 200,000 to 260,000 pounds of U3O8 into its current portfolio of supply agreements with U.S. nuclear utilities at an expected sales price of approximately $54 – $58 per pound, resulting in an estimated 46% – 50% gross margin.
During Q1-2023, the Company purchased a total of 120,000 pounds of U.S.-origin U3O8 on the spot market for a weighted-average price of $50.25 per pound.
Over the past several months, the Company has made significant progress in preparing four (4) of our conventional uranium and uranium/vanadium mines to be ready to resume ore production, including significant workforce expansion and performing needed rehabilitation and development of surface and underground infrastructure.
On February 15, 2023, the Company announced it had completed its previously announced sale of its Alta Mesa ISR Project to enCore Energy Corp. (“enCore“) for total consideration of $120 million, comprised of $60 million in cash and $60 million in a secured convertible note bearing interest at a rate of eight percent (8%) per annum, convertible into common shares of enCore at a price of $2.9103 per share. This sale of a lower priority project provides Energy Fuels with significant additional cash and working capital, enabling the Company to ramp-up its US industry-leading uranium and REE production, while avoiding dilution to shareholders.
In connection with the Alta Mesa Transaction, on May 3, 2023, the Company completed the sale of its Prompt Fission Neutron assets, including the underlying contracts, technology, licenses and intellectual property (collectively, the “PFN Assets“), to enCore in exchange for cash consideration received at closing of $3.10 million. At closing, the PFN Assets, which the Company had purchased in 2020 for cash consideration of $0.5 million, had a net book value of $0.35 million. The PFN Assets were used exclusively at the Alta Mesa ISR Project and are not required for any of the Company’s other properties. Should the Company have the need for the use of a PFN tool in the future, the Company retained a 20-year usage right, subject to the availability of the PFN Assets, to purchase, lease and/or license at least one PFN tool and all related and/or required equipment, technology and licenses on commercially reasonable terms.
As of April 28, the spot price of U3O8 was $53.75 per pound according to data from TradeTech.
Rare Earth Element Highlights:
During the three months ended March 31, 2023, the Company produced approximately 250 MT of high-purity, partially separated mixed RE Carbonate from monazite, containing approximately 115 MT of total rare earth oxides (“TREO“), which is the most advanced REE material being produced commercially in the U.S. today.
The Company has in circuit an additional 65 to 115 MT of RE Carbonate, containing 35 to 55 MT of TREO, which it expects to package for sale during the second quarter of 2023.
In early 2023, the Company began modifying and enhancing its existing solvent extraction (“SX“) circuits at the Mill to be able to produce separated REE oxides (“Phase 1“). The Company has begun this development work in its SX building and ordered most of the major components for this project, which are expected to be delivered to the Mill in Q3-2023. “Phase 1” is expected to be completed and fully commissioned by late 2023 or early 2024 and have the capacity to produce roughly 800 to 1,000 MT of recoverable separated neodymium-praseodymium (“NdPr“) oxide per year, subject to securing sufficient monazite feed. “Phase 1” is expected to position Energy Fuels as one of the world’s leading producers of NdPr outside of China. “Phase 1” capital costs are expected to total approximately $25 million. 1,000 MT of NdPr in permanent magnets could power up to 1 million electric vehicles (“EVs“) per year.
The Company is engineering further enhancements at the Mill to increase NdPr production capacity to up to approximately 3,000 MT per year by 2026 (“Phase 2“), and to produce separated dysprosium (“Dy“), terbium (“Tb“) and potentially other advanced REE materials in the future from monazite and potentially other REE process streams by 2027 (“Phase 3”).
On February 13, 2023, the Company announced it had completed its previously announced acquisition of a large heavy mineral sands project in Brazil (the “Bahia Project“), which has the potential to supply the Company’s growing REE business with 3,000 – 10,000 MT of REE-bearing natural monazite sand per year for decades. The Bahia Project also contains significant quantities of high-value titanium (ilmenite and rutile) and zirconium (zircon) minerals.
During Q1-2023, the Company completed 2,266 meters of sonic drilling at the Bahia Project to confirm and further delineate the rare earth, titanium, and zirconium mineralization. The Company expects to commence further sonic drilling in Q3-2023, announce drilling results later this year, and commence preparation of an SK-1300 and NI 43-101 compliant mineral resource estimate.
The Company continues active discussions with several additional suppliers of natural monazite around the world to significantly increase the supply of feed for our growing REE initiative.
As of April 28, the spot price of NdPr oxide was $64 per kg, according to data from Asian Metal.
Vanadium Highlights:
During Q1-2023, the Company sold approximately 79,344 pounds of existing V2O5 inventory, for an average weighted sales price of $10.98 per pound of V2O5, for a total gross margin of 37%.
Due to the high-purity of the Company’s vanadium product, these sales occurred at a premium to V2O5 spot prices prevailing at the time of the sales.
As of April 28, the spot price of V2O5 was $9.75 per pound, according to data from Fastmarkets.
Medical Isotope Highlights:
The Company continued advancing its program to evaluate the potential to recover radioisotopes from its process streams for use in emerging targeted alpha therapy (“TAT“) cancer therapeutics.
Mark S. Chalmers, Energy Fuels’ President and CEO, stated:
“Energy Fuels had an exceptional 1st quarter on several metrics, including earnings of $114.26 million, achieving healthy margins on our product sales, increasing our working capital position to $143.61 million, increasing our total assets, and reducing our total liabilities. We also significantly enhanced our fixed asset portfolio by selling the non-core Alta Mesa uranium property for $120.00 million and closing on the purchase of the Bahia Project in Brazil, which has the potential to feed our REE separation circuits with low-cost raw materials for several decades.
“On uranium, we sold 300,000 pounds of U3O8 to the newly established U.S. Uranium Reserve for $18.47 million, or $61.57 per pound, representing a significant premium to the current spot price of uranium, resulting in a $10.76 million gross margin. We are also getting ready to sell up to another 260,000 pounds of U3O8 into our utility contract portfolio, also at healthy operating margins. We are closely tracking uranium prices, which have shown recent strength, for opportunities to sell additional uranium under long-term contracts to nuclear utilities at increasingly higher prices.
“Energy Fuels realized a significant gain of $116.45 million on the sale of our non-core Alta Mesa ISR project in Texas. Total consideration included $60 million of cash and a $60 million 2-year convertible note bearing 8% interest per year, fully secured by the property. This transaction also resulted in us receiving an additional $3.48 million cash for the return of collateral on the project’s reclamation bonds and a reduction in our standby costs of approximately $2 million per year.
“At the same time, we continue to perform significant work at four of our conventional uranium mines to get them ready to resume ore production. This includes the La Sal and Beaver mines at the La Sal Complex in Utah, the Whirlwind mine in Colorado and the Pinyon Plain mine in Arizona. Energy Fuels currently has sufficient uranium in inventory to fulfill our current utility contract requirements into 2025. However, we are seeking additional contracts and spot sale opportunities, along with a continuation of uranium purchasing by the U.S. government. Therefore, we could begin ore production at one or more of these projects by 2024.
“We continued to build our REE business as well. We began modifications and enhancements at the White Mesa Mill expected to produce up to 1,000 MT per year of NdPr oxide by late 2023 or early 2024, subject to receipt of sufficient monazite feed. We ordered the REE SX cells from a fabricator, with delivery to the Mill expected in Q3 or Q4-2023. Following delivery, we expect to install, commission, and optimize these cells, complete other modifications and enhancements to the existing circuits, and begin commercial production of NdPr oxide, along with uranium, soon thereafter. Upon completion, we believe Energy Fuels’ White Mesa Mill in Utah will house one of the largest NdPr production circuits in the world, excluding China. We also expect to begin piloting ‘heavy’ REE separation later this year, which will provide valuable knowledge for designing and building our Phase 3 Dy, Tb and potentially other REE separation circuits.
“Monazite supply is of course critical to Energy Fuels’ rare earth plans. We continue to advance discussions with several existing monazite suppliers around the world. And, we completed the acquisition of the Bahia Project in Brazil, which will allow us to control our own low-cost REE supply. The Bahia Project has the potential to produce between 3,000 to 10,000 MT of monazite, containing 300 to 1,000 MT of NdPr oxide, per year. We are currently in the midst of a sonic drilling program on the property to confirm and better define the REE (monazite), titanium (ilmenite, rutile, leucoxene) and zirconium (zircon) resources, which will inform our mine plan and permitting. We hope to commence production in late 2025 or early 2026, and ramp-up from there.
“Finally, we sold a small quantity of our vanadium inventory into recent market strength, which saw spot prices reach $10.80 per pound in February, according to Fastmarkets. Because we produce a high-purity V2O5 product that is attractive to specialty alloy and chemical markets, we were able to execute this sale at a premium to reported prices. Accordingly, our realized sales price was $10.98 per pound of V2O5 on these sales.”
Conference Call and Webcast at 4:00 pm ET on May 9, 2023:
Energy Fuels will be hosting a conference call and webcast on May 9, 2023 at 4:00 pm ET (2:00 pm MT) to discuss its Q1-2023 financial results, the outlook for 2023, and its uranium, rare earths, vanadium, and medical isotopes initiatives.
To instantly join the conference call by phone, please use the following link to easily register your name and phone number. After registering, you will receive a call immediately and be placed into the conference call: RAPIDCONNECT
Alternatively, you may dial in to the conference call by calling 1-888-664-6392, and you will be connected to the call by an Operator.
You may also access viewer-controlled Webcast slides and/or stream the call by following this link: WEBCAST
A replay of the call will be available until May 24, 2023 by calling (888) 390-0541 or (416) 764-8677 and entering the replay code, 680506#.
Selected Summary Financial Information:
Three Months Ended
March 31,
$000’s, except per share data
2023
2022
Results of Operations:
Uranium concentrates revenues
$ 18,470
$ —
Vanadium concentrates revenues
871
2,412
Total revenues
19,613
2,937
Gross margin
11,347
45
Operating loss
(405)
(10,213)
Net income (loss)
114,264
(14,730)
Basic and diluted net income (loss) per common share
0.72
(0.09)
As of
As of
$000’s
March 31, 2023
December 31, 2022
Financial Position:
Working capital
$ 143,611
$ 116,966
Property, plant and equipment, net
14,635
12,662
Mineral properties
113,834
83,539
Current assets
148,914
135,590
Total assets
375,451
273,947
Current liabilities
5,303
18,624
Total liabilities
16,438
29,538
ABOUT ENERGY FUELS
Energy Fuels is a leading US-based critical minerals company. The Company, as the leading producer of uranium in the United States, mines uranium and produces natural uranium concentrates that are sold to major nuclear utilities for the production of carbon-free nuclear energy. Energy Fuels recently began production of advanced rare earth element (“REE“) materials, including mixed REE carbonate, and plans to produce commercial quantities of separated REE oxides in the future. Energy Fuels also produces vanadium from certain of its projects, as market conditions warrant, and is evaluating the recovery of radionuclides needed for emerging cancer treatments. Its corporate offices are in Lakewood, Colorado, near Denver, and substantially all its assets and employees are in the United States. Energy Fuels holds two of America’s key uranium production centers: the White Mesa Mill in Utah and the Nichols Ranch in-situ recovery (“ISR“) Project in Wyoming. The White Mesa Mill is the only conventional uranium mill operating in the US today, has a licensed capacity of over 8 million pounds of U3O8 per year, has the ability to produce vanadium when market conditions warrant, as well as REE products, from various uranium-bearing ores. The Nichols Ranch ISR Project is on standby and has a licensed capacity of 2 million pounds of U3O8 per year. The Company recently acquired the Bahia Project in Brazil, which is believed to have significant quantities of titanium (ilmenite and rutile), zirconium (zircon) and REE (monazite) minerals. In addition to the above production facilities, Energy Fuels also has one of the largest NI 43-101 compliant uranium resource portfolios in the US and several uranium and uranium/vanadium mining projects on standby and in various stages of permitting and development. The primary trading market for Energy Fuels’ common shares is the NYSE American under the trading symbol “UUUU,” and the Company’s common shares are also listed on the Toronto Stock Exchange under the trading symbol “EFR.” Energy Fuels’ website is www.energyfuels.com.
Daniel Kapostasy, P.G., Director of Technical Services for Energy Fuels, is a Qualified Person as defined by Canadian National Instrument 43-101 and has reviewed and approved the technical disclosure contained in this news release, including sampling, analytical, and test data underlying such disclosure.
The data collected and provided in this disclosure related to the Bahia Project is derived entirely from the exploration reports for each of the seventeen mineral process areas. Mr. Kapostasy has reviewed these reports in detail and discussed the methods used with the project geologist in charge of field and laboratory activities for the previous owners who is also currently an employee of Energy Fuels Brazil, Ltda. Heavy mineral concentrations were derived for every meter drilled using heavy liquid separations, a standard method of heavy mineral determination.
To determine the concentration of the various heavy minerals in a sample, the heavy fraction was separated from the silica sand by using heavy liquid separation. The heavy fraction was then mounted in epoxy or dispersed on slide glass and viewed under a microscope. A geologist can then identify the various minerals and determine the concentration of each mineral through a process called point counting, whereby the geologist identifies each sand grain individually, tallies the number of each mineral and then divides by the total.
Verification of the heavy mineral concentration was started by the Company in September 2022, when it hired a contract driller to collect samples using a sonic rig. While no laboratory analyses have been received to date, visual estimation of the heavy mineral quantity indicates that the historical values seen at the various process areas are valid.
Cautionary Note Regarding Forward-Looking Statements: This news release contains certain “Forward Looking Information” and “Forward Looking Statements” within the meaning of applicable United States and Canadian securities legislation, which may include, but are not limited to, statements with respect to: production and sales forecasts; costs of production; any expectation that the Company will be awarded any future sales under the U.S. Uranium Reserve; scalability, and the Company’s ability and readiness to re-start, expand or deploy any of its existing projects or capacity to respond to any improvements in uranium market conditions or in response to the Uranium Reserve; any expectation as to future uranium, vanadium, RE Carbonate, REE oxide, or REE market fundamentals or sales; any expectation as to recommencement of production at any of the Company’s uranium mines or the timing thereof; any expectation regarding any remaining dissolved vanadium in the Mill’s tailings facility solutions or the ability of the Company to recover any such vanadium at acceptable costs or at all; any expectation as to longer term fundamentals in the market and price projections; any expectation that the Company will maintain its position as a leading U.S.-based critical minerals company or as the leading producer of uranium in the U.S.; any expectation with respect to timelines to production; any expectation that the sale of the Alta Mesa project and the use of the proceeds from that sale will not result in any dilution to shareholders; any expectation that the Mill will be successful in producing RE Carbonate on a full-scale commercial basis; any expectation that Energy Fuels will be successful in developing U.S. separation, or other value-added U.S. REE production capabilities at the Mill, or otherwise, including the timing of any such initiatives and the expected production capacity or capital and operating costs associated with any such production capabilities; any expectation with respect to the quantities of monazite to be acquired by Energy Fuels, the quantities of RE Carbonate or REE oxides to be produced by the Mill or the quantities of contained TREO in the Mill’s RE Carbonate; any expectation that the Company may sell its separated NdPr oxide to electric vehicle manufacturers; any expectation that the Bahia Project has the potential to feed the Mill with REE and uranium-bearing monazite sand for decades or at all; any expectation that the Company will complete comprehensive sonic drilling and geophysical mapping at the Bahia Project or complete an Initial Assessment under SK-1300 (U.S.) and a Technical Report Technical Report under NI 43-101 (Canada) during 2023, or otherwise; any expectation that the Company’s evaluation of radioisotope recovery at the Mill will be successful; any expectation that the potential recovery of medical isotopes from any radioisotopes recovered at the Mill will be feasible; any expectation that any radioisotopes can be recovered at the Mill will be sold on a commercial basis; any expectation as to the quantities to be delivered under existing uranium sales contracts; and any expectation that the Company will be successful in completing any additional contracts for the sale of uranium to U.S. utilities on commercially reasonable terms or at all. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as “plans,” “expects,” “does not expect,” “is expected,” “is likely,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates,” “does not anticipate,” or “believes,” or variations of such words and phrases, or state that certain actions, events or results “may,” “could,” “would,” “might” or “will be taken,” “occur,” “be achieved” or “have the potential to.” All statements, other than statements of historical fact, herein are considered to be forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements express or implied by the forward-looking statements. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements include risks associated with: commodity prices and price fluctuations; engineering, construction, processing and mining difficulties, upsets and delays; permitting and licensing requirements and delays; changes to regulatory requirements; legal challenges; the availability of sources of Alternate Feed Materials and other feed sources for the Mill; competition from other producers; public opinion; government and political actions; available supplies of monazite; the ability of the Mill to produce RE Carbonate, REE oxides or other REE products to meet commercial specifications on a commercial scale at acceptable costs or at all; market factors, including future demand for REEs; the ability of the Mill to be able to separate radium or other radioisotopes at reasonable costs or at all; market prices and demand for medical isotopes; and the other factors described under the caption “Risk Factors” in the Company’s most recently filed Annual Report on Form 10-K, which is available for review on EDGAR at www.sec.gov/edgar.shtml, on SEDAR at www.sedar.com, and on the Company’s website at www.energyfuels.com. Forward-looking statements contained herein are made as of the date of this news release, and the Company disclaims, other than as required by law, any obligation to update any forward-looking statements whether as a result of new information, results, future events, circumstances, or if management’s estimates or opinions should change, or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements. The Company assumes no obligation to update the information in this communication, except as otherwise required by law.
SOURCE Energy Fuels Inc.
For further information: Investor Inquiries: Energy Fuels Inc., Curtis Moore, SVP – Marketing and Corporate Development, (303) 974-2140 or Toll free: (888) 864-2125, [email protected], www.energyfuels.com
Announced Positive Preliminary Safety and Efficacy Results from the Phase 1/2 Trial of OCU400 for the Treatment of Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA)
Received Orphan Drug Designation (ODD) from the FDA for OCU410ST for the Treatment of ABCA4-Associated Retinopathies Including Stargardt, Retinitis Pigmentosa (RP19), and Cone-Rod Dystrophy 3 (CORD3) Diseases
Submitted Multiple Proposals for Federal Funding of Ocugen’s Inhaled Vaccines for COVID-19 and Flu
MALVERN, Pa., May 05, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today reported first quarter 2023 financial results along with a general business update.
“I am excited about our pipeline achievements to date — especially those for our modifier gene therapy platform,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “The preliminary positive efficacy and safety results from our Phase 1/2 trial of OCU400 support the potential for this first-in-class therapeutic approach to be a viable gene-agnostic treatment for RP and LCA patients. Based on proof-of-concept data, we are getting ready to introduce two more programs with the modifier concept into the clinic —including OCU410 for dry age-related macular degeneration.”
OCU410ST recently received broad ODD from the FDA for the treatment of ABCA4-associated retinopathies including Stargardt, RP19, and CORD3 diseases. This designation acknowledges the potential for OCU410ST to fulfill a significant unmet medical need and represents a noteworthy milestone in our effort to develop innovative treatments for inherited retinal diseases.
Ocugen remains dedicated to our potentially first-in-class ophthalmic programs targeting blindness diseases and vaccines to support public health. Since the beginning of the year, the Company has been leading advocacy efforts and pursuing government funding to potentially bring its inhaled vaccines for COVID-19 and flu to patients and healthcare professionals searching for next generation options. Given the FDA’s recent cancellation of emergency use authorizations issued to monovalent vaccines, Ocugen will now focus its efforts solely on the development of the inhaled mucosal vaccine platform, starting with quadrivalent flu and bivalent COVID-19.
“We will continue to deliver on our corporate goals and scientific programs throughout 2023 and look forward to providing updates across our comprehensive portfolio in the coming months,” concluded Dr. Musunuri.
Ophthalmic Gene Therapies
OCU400 – Preliminary safety and efficacy results among RP patients treated in the first two cohorts of the Phase 1/2 trial indicate positive trend in multi-luminance mobility testing and best-corrected visual acuity scores for OCU400 treated eyes. Received FDA approval to enroll pediatric patients in the ongoing Phase 1/2 trial; dosing to be initiated in the second quarter of 2023. Phase 3 adult trial to be initiated near the end of 2023.
OCU410 – Ocugen intends to submit an Investigational New Drug (“IND”) application for OCU410 in the second quarter of 2023 to initiate a Phase 1/2 trial.
OCU410ST – FDA granted ODD to OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt, RP19, and CRD3 diseases. Ocugen intends to submit an IND application for OCU410ST in the second quarter of 2023 to initiate a Phase 1/2 trial.
Ophthalmic Biologic Product
OCU200 – Submitted an IND application to the FDA in February 2023 to initiate a Phase 1 trial targeting diabetic macular edema. In April, the IND was placed on clinical hold by the FDA as part of its request for additional information related to chemistry, manufacturing, and controls prior to initiating the Phase 1 trial. The company plans to respond to the FDA promptly to get FDA clearance to initiate the Phase 1 trial.
Regenerative Cell Therapies
NeoCart® – Renovations continue on cGMP manufacturing facility for NeoCart, with completion planned for the fourth quarter of 2023.
Vaccines Portfolio
OCU500/OCU510/OCU520 – Intend to submit an IND application to the FDA in late 2023/early 2024. Continuing to work with government agencies to obtain government funding.
COVAXIN™ – Ocugen has concluded that the development of COVAXIN in North America is not commercially viable as a result of the FDA’s recent decision around monovalent vaccines.
First Quarter 2023 Financial Results
The Company’s cash, cash equivalents, and investments totaled $76.7 million as of March 31, 2023 compared to $90.9 million as of December 31, 2022. The Company estimates that its current cash, cash equivalents, and investments will enable it to fund its operations into the first quarter of 2024. The Company had 226.4 million shares of common stock outstanding as of March 31, 2023.
Total operating expenses for the three months ended March 31, 2023 were $17.8 million and included research and development expenses of $9.6 million and general and administrative expenses of $8.2 million. This compares to total operating expenses for the three months ended March 31, 2022 of $18.0 million that included research and development expenses of $7.9 million and general and administrative expenses of $10.1 million.
Ocugen reported a $0.07 net loss per common share for the three months ended March 31, 2023 compared to a $0.09 net loss per common share for the three months ended March 31, 2022.
Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.
Attendees are invited to participate on the call or webcast using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 4613996 Webcast: Available on the events section of the Ocugen investor site
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
CALGARY, AB, May 4, 2023 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces April 2023 average sales volumes and an operational update and timing for release of our Q1 2023 results and earnings call.
April 2023 Sales Volumes
April sales volumes averaged 1,972 boepd, including natural gas sales of 11.3 MMcfpd and associated natural gas liquids sales from condensate of 84 bopd, based on field estimates. Sales volumes in April declined from our average Q1 2023 of 2,767 boepd. April sales volumes were lower due to reduced demand during the month from Bahiagás as well as higher nominated volumes from our partner at the Caburé unit. We anticipate May sales volumes to continue at rates similar to average volumes in April. Future sales volumes will be dependent on available Caburé unit production, production additions from our Murucututu field with the development work planned this year and overall demand from Bahiagás.
Operational Update
In March, we commenced stimulation operations at our 197(1) well on our Murucututu natural gas field. While operations have progressed slower than initially scheduled, we have now successfully stimulated three of four planned intervals at the well, injecting a total of 89 tonnes of sand into the formation. Stimulation of the final interval is expected to be completed shortly and we expect the well to be on production this month. Following completion of stimulation operations, we plan to drill two Murucututu fit-for-purpose development wells in the second half of 2023.
On our Bom Lugar field, we spud our first development well (BL-06) on April 30th and drilling is underway. The BL-06 well is targeting the Caruaçu Formation with additional potential in the deeper Gomo and Agua Grande Formations. We expect drilling to be completed late in the second quarter.
Upcoming Q1 2023 Results and Live Webcast
Alvopetro anticipates announcing first quarter 2023 results on May 10, 2023, after markets close, and will host a live webcast to discuss the results at 8:00 am Mountain time, on May 11, 2023. Details for joining the event are as follows:
The webcast will include a question and answer period. Online participants will be able to ask questions through the Zoom portal. Dial-in participants can email questions directly to [email protected].
Alvopetro Energy Ltd.’svision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé natural gas field and our strategic midstream infrastructure.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
All amounts contained in this new release are in United States dollars, unless otherwise stated and all tabular amounts are in thousands of United States dollars, except as otherwise noted.
Abbreviations:
bbls
=
barrels
boepd
=
barrels of oil equivalent (“boe”) per day
bopd
=
barrels of oil and/or natural gas liquids (condensate) per day
MMcf
=
million cubic feet
MMcfpd
=
million cubic feet per day
Q1 2023
=
three months ended March 31, 2023
BOE Disclosure. The term barrels of oil equivalent (“boe”) may be misleading, particularly if used in isolation. A boe conversion ratio of six thousand cubic feet per barrel (6Mcf/bbl) of natural gas to barrels of oil equivalence is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. All boe conversions in this news release are derived from converting gas to oil in the ratio mix of six thousand cubic feet of gas to one barrel of oil.
Forward-Looking Statements and Cautionary Language. This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward–looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning the anticipated timing of completion of the 197(1) stimulation and drilling of the BL-06 well, anticipated timing of production commencement from the 197(1) well, expected natural gas allocations from the Caburé unit, natural gas sales and gas deliveries under the Company’s long-term gas sales agreement, plans relating to the Company’s operational activities, proposed exploration development activities and the timing for such activities and exploration and development prospects of Alvopetro. The forward–looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to expectations and assumptions concerning the performance of producing wells and reservoirs, foreign exchange rates, well development and operating performance, the timing of regulatory licenses and approvals, equipment availability, the success of future drilling, completion, testing, recompletion and development activities, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, the outlook for commodity markets and ability to access capital markets, general economic and business conditions, the impact of the COVID-19 pandemic, weather and access to drilling locations, the availability and cost of labour and services, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors. Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our annual information form which may be accessed on Alvopetro’s SEDAR profile at www.sedar.com. The forward-looking information contained in this news release is made as of the date hereof and Alvopetro undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.
“We are excited to present CC-42344’s promising safety, tolerability and preclinical data, including robust antiviral activity in an influenza-infected human respiratory epithelium model,” said Dr. Lee. “Our Phase 1 data continue to show this molecule’s potential as an oral therapeutic for the treatment of pandemic and seasonal influenza. Given that CC-42344 has shown sub-nanomolar potency and a novel mechanism of action with high barrier to resistance, we believe it could be used as monotherapy or in combination with other influenza antivirals. We look forward to initiating a Phase 2a influenza A human challenge study in the second half of 2023.”
The slide deck accompanying Dr. Lee’s discussion “First-in-Human Study of CC-42344, a Novel Broad-Spectrum Influenza A Polymerase PB2 Inhibitor” has been posted to the Presentations section of the company website.
About CC-42344 CC-42344 is a novel PB2 inhibitor discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. CC-42344 targets the influenza polymerase complex, an essential enzyme required for the viral replication. In vitro testing showed CC-42344’s potent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to osteltamivir (Tamiflu®) and baloxavir marboxil (Xofluza®).
About ISIRV The International Society for Influenza and other Respiratory Virus Diseases (ISIRV) is an independent and international scientific professional society promoting the prevention, detection, treatment and control of influenza and other respiratory virus diseases. ISIRV was founded in 2005 as the first scientific society with a fully worldwide remit focused on influenza and respiratory virus disease. As a global scientific society, ISIRV fulfils this mission through promoting the exchange and dissemination of information, facilitating the interaction of scientists and of public health specialists and the promotion of international collaborative efforts against these diseases. More information is available here.
About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s influenza A product candidate CC-42344’s potential as an oral therapeutic for the treatment of pandemic and seasonal influenza, including either as monotherapy or in combination with other influenza antivirals, and the anticipated initiation of a Phase 2a influenza A human challenge study in the second half of 2023. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, interest rate increases, the current banking crisis and the Ukraine war on our Company, our collaboration partners, and on the U.S. and U.K. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current Contract Research Organization (CRO) and any future CROs and Contract Manufacturing Organizations, the results of the studies for CC-42344, the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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-month period ended March 31, 2023.
First Quarter 2023 Highlights
Record first quarter revenue
Net revenue up 21% over the prior-year quarter
Net income attributable to common stockholders up 8% over the prior-year quarter
Consolidated EBITDA down 28% compared to the prior-year quarter
Operating cash flow down 31% compared to the prior-year quarter
Free cash flow down 73% compared to the prior-year quarter
Quarterly cash dividend of $0.05 per share
Entered into $275 Million Credit Facility
“Entravision saw continued growth in the first quarter of 2023, with revenue up 21% year-over-year,” said Chris Young, Interim Chief Executive Officer and Chief Financial Officer. “Growth for the quarter was led by our digital segment, which is impressive given difficult macro conditions and decreased political advertising revenue from last year.”
Mr. Young continued, “With a solid balance sheet in place, strong free cash flow generation, and an acute focus on expense management, Entravision is well-equipped to navigate the current economic environment. As we progress through additional quarters, we will continue to seek out opportunities, including acquisitions, that will enhance our digital offerings and strengthen our ability to compete internationally.”
Quarterly Cash Dividend
The Company announced today that its 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 $4.4 million. The quarterly dividend will be payable on June 30, 2023 to shareholders of record as of the close of business on June 16, 2023, and the common stock will trade ex-dividend on June 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.
$275 Million Credit Facility
On March 17, 2023, the Company entered into the 2023 Amended and Restated Credit Facility (the “2023 Credit Facility”), which consists of a $200 million senior secured Term A Facility, which was drawn in full, and a $75 million Revolving Credit Facility, of which $11.5 million was drawn. In addition, the 2023 Amended and Restated Credit Agreement (the “2023 Credit Agreement”) provides that the Company may increase the aggregate principal amount of the 2023 Credit Facility by an additional amount equal to $100 million plus the amount that would result in the Company’s first lien net leverage ratio (as such term is used in the 2023 Credit Agreement) not exceeding 2.25 to 1.0, subject to the Company satisfying certain conditions.
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 9.
Net revenue in the first quarter of 2023 totaled $239.0 million, up 21% from $197.2 million in the prior-year period. Of the overall increase, $42.8 million was attributable to our digital segment and was primarily due to advertising revenue growth from our digital commercial partnerships business, and due to our VIEs, which did not contribute to our financial results in our digital segment in the comparable period. The overall increase was partially offset by a decrease of $0.6 million attributable to our television segment, primarily due to decreases in political advertising revenue and national advertising revenue, partially offset by increases in local advertising revenue, spectrum usage rights revenue and retransmission consent revenue. In addition, the overall increase was partially offset by a decrease of $0.4 million attributable to our audio segment, primarily due to a decrease in political advertising revenue, and decreases in local and national advertising revenue.
Cost of revenue in the first quarter of 2023 totaled $167.8 million, up 29% from $129.9 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 VIEs, which did not contribute to our financial results in our digital segment in the comparable period.
Operating expenses in the first quarter of 2023 totaled $52.6 million, up 20% from $43.9 million in the prior-year period. Of the overall increase, $6.3 million was attributable to our digital segment and was primarily due to our VIEs, which did not contribute to our financial results in our digital segment in the comparable period, an increase in salary expense, an increase in non-cash stock-based compensation, and an increase in expenses associated with the increase in digital advertising revenue. Additionally, of the overall increase in operating expenses, $0.9 million was attributable to our television segment primarily due to an increase in non-cash stock-based compensation, increased rent expense in the temporary office space until the move to our new permanent offices is completed, and an increase in bad debt expense. In addition, of the overall increase in operating expenses, $1.6 million was attributable to our audio segment primarily due to increases in salaries and music license fees, and increased rent expense in the temporary office space until the move to our new permanent offices is completed. The increases in non-cash stock-based compensation are mainly a result of the 2023 annual restricted stock unit (“RSU”) grant, which was made in February 2023 compared to the 2022 annual grant, which was made in December 2022.
Corporate expenses in the first quarter of 2023 totaled $10.5 million, up 20% from $8.7 million in the prior-year period. The increase was primarily due to an increase in non-cash stock-based compensation, which is mainly a result of the 2023 annual RSU grant, which was made in February 2023 compared to the 2022 annual grant, which was made in December 2022, an increase in professional service fees, and an increase in audit fees.
Balance Sheet and Related Metrics
Cash and marketable securities as of March 31, 2023 totaled $179.8 million. Total debt under the Company’s credit agreement was $211.5 million. Net of $50 million of cash and marketable securities, total leverage as defined in the Company’s credit agreement was 1.7 times as of March 31, 2023. Net of total cash and marketable securities, total leverage was 0.3 times.
Notice of Conference Call
Entravision Communications Corporation will hold a conference call to discuss its first quarter 2023 results on Thursday, May 4, 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 10176751. 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 global advertising solutions, media and technology company. Over the past three decades, we have strategically evolved into a digital powerhouse, expertly connecting brands to consumers in the U.S., Latin America, Europe, Asia and Africa. Our digital segment, the company’s largest by revenue, offers a full suite of end-to-end advertising services in 40 countries. We have commercial partnerships with Meta, Twitter, TikTok, and Spotify, and marketers can use our Smadex and other platforms to deliver targeted advertising to audiences around the globe. In the U.S., we maintain a diversified portfolio of television and radio stations that target Hispanic audiences and complement our global digital services. Entravision remains the largest affiliate group of the Univision and UniMás television networks. 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
Company to host conference call and webcast at 4:30 p.m. ET on Monday, May 15, 2023
NEWTOWN, Pa., May 04, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), 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 first quarter 2023 financial results on Monday, May 15, 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 9090989.
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 (RDEB-associated SCC).
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.
IRVING, Texas–(BUSINESS WIRE)– Salem Media Group, Inc. (NASDAQ: SALM) announced today that it plans to report its first quarter 2023 financial results after the market closes on May 9, 2023.
The company also plans to host a teleconference to discuss its results on May 9, 2023, at 4:00 PM Central Time. To access the teleconference, please dial (888) 770-7291, and then ask to be joined to the Salem Media Group First Quarter 2023 call or listen to the webcast.
A replay of the teleconference will be available through May 23, 2023, and can be heard by dialing (800) 770-2030 – replay pin number 2413416, or on the investor relations portion of the company’s website, located at investor.salemmedia.com.
ABOUT SALEM MEDIA GROUP:
Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.com, Facebook and Twitter.
MELVILLE, N.Y. – May 4, 2023– Comtech (NASDAQ: CMTL) announced today that Aarna Networks, a leading provider of network automation and orchestration solutions, will become the Company’s latest publicly revealed EVOKE technology partner.
As the fourth publicly announced EVOKE technology partner, Aarna Networks will work with Comtech to create new integrated cloud-native solutions for emerging commercial and government use cases. By combining Aarna Networks technologies with Comtech’s Dynamic Cloud Platform (DCP), the companies will enable customers to easily add and manage a variety of open architecture cloud-based applications across private, hybrid, and public networks, in both terrestrial and non-terrestrial environments.
“By working with Aarna Networks as an EVOKE technology partner, we will open the door to new cloud-based applications that will support the convergence of communications infrastructures and empower individuals, communities, businesses, and governments by providing access to new technologies,” said Ken Peterman, President and CEO, Comtech. “As connectivity services expand into new global markets, the need for innovative cloud applications will continue to grow. By integrating Aarna Networks zero-touch edge orchestration technologies with Comtech’s DCP offerings, we will multiply the value our cloud-native solutions can bring to 5G, satellite communications, and edge computing customers around the world.”
Comtech’s DCP is designed to be infrastructure, cloud, and application agnostic. Comtech’s DCP also unlocks the availability of new third-party cloud-based applications across current and future computing environments.
Aarna Network’s software, and software as a service (SaaS) solutions, leverage open source, cloud native, and DevOps methodologies to provide zero-touch edge and 5G service orchestration and management (SMO) services.
“Aarna Networks is thrilled to be an EVOKE technology partner and to integrate with Comtech’s DCP,” said Amar Kapadia, Co-founder and CEO, Aarna Networks. “This allows us to bring edge and 5G services orchestration to diverse infrastructures and management systems for a broad set of industry use cases. Our open source, vendor neutral Open Radio Access Network (O-RAN) SMO offering is important for a variety of customers segments across global markets.”
EVOKE is Comtech’s Innovation Foundry, which is led by the company’s Chief Growth Officer, Anirban Chakraborty, and is dedicated to creating and accelerating transformational changes across the global technology landscape. EVOKE engages with customers, partners, and suppliers to push the boundaries of technologies that will lay the foundation of connectivity as well as shape future societies and ecosystems.
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.
About Aarna Networks
Aarna Networks solves enterprise edge and 5G management complexity through zero-touch edge orchestration at scale. We’re on a mission to help enterprises and network operators unlock previously unimagined new services and drastically slash operational costs and improve time to market. Aarna’s software and SaaS solutions leverage open source, cloud native, and DevOps methodologies to provide zero-touch edge and 5G service orchestration and management services. Visit us at https://www.aarnanetworks.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.
FLORHAM PARK, N.J., May 04, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that the Company will release financial results for the first quarter of 2023 on Monday, May 15, 2023, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.
Monday, May 15, 2023, 8:00 AM ET Domestic: 877-407-3088 International: 201-389-0927 Conference ID: 13738216 Webcast: PDS Biotech Earnings Webcast
After the live webcast, the event will be archived on PDS Biotech’s website for six months.
About PDS Biotechnology PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16- associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
Multiple Additional Indications Possible, Including Autoimmune Diseases: Pipeline within a Product
Published Non-Human Primate Studies Show TNX-1500 Prolongs Renal and Heart Allograft Survival
Phase 1 Clinical Trial of TNX-1500 Expected to Start Third Quarter 2023
CHATHAM, N.J., May 04, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 1 clinical trial with TNX-1500 (anti-CD40L monoclonal antibody [mAb]). The first indication Tonix is seeking for TNX-1500 is the prevention of organ rejection in patients receiving a kidney transplant. The Company expects to initiate enrollment in the Phase 1 study in the third quarter of 2023.
The IND application for TNX-1500 was supported by preclinical allotransplantation studies conducted at the Massachusetts General Hospital (MGH), led by principal investigators Tatsuo Kawai, MD, PhD, A. Benedict Cosimi Chair in Transplant Surgery, MGH and Professor of Surgery, Harvard Medical School (HMS), and Richard N. Pierson III, M.D., scientific director of the Center for Transplantation Sciences in the Department of Surgery at MGH and Professor of Surgery at HMS.
“This is an important milestone as we advance TNX-1500 into clinical development,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Despite advancements in the field of solid organ transplantation, there remains a significant need for new treatments with improved activity and tolerability to prevent organ transplant rejection. Our primary focus of early development will be allotransplantation in which the donor organ comes from another human. However, in the longer term we hope to develop TNX-1500 for xenograft transplantation in which the donor organ comes from a genetically engineered pig.”
Dr. Lederman continued, “We view TNX-1500 as a pipeline within a product, because of its potential to treat a number of autoimmune diseases. Anti-CD40L mAbs have demonstrated activity and tolerability in autoimmune diseases like systemic lupus erythematosus and Sjögren’s Syndrome. An anti-CD40L mAb is also in development for multiple sclerosis. CD40L is a member of the TNFα super gene family. Other TNFα super gene members have been the targets of successful mAb therapeutics: TNFα and RANKL for autoimmune diseases and osteoporosis, respectively. Still other TNFα super gene family members are targeted by mAbs in development including TNF-like ligand 1A (TL1A) and CD30L for ulcerative colitis and Ox40L for atopic dermatitis.”
TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease FcγRIIA binding and to therefore reduce the potential for thrombosis. Preclinical studies in non-human primates demonstrated that TNX-1500 showed activity in preventing allograft organ rejection and was well tolerated1,2.
About TNX-1500
TNX-1500 (Fc-modified anti-CD40L mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), which is also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the treatment of autoimmune diseases and for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT). A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Two articles have recently published in the American Journal of Transplantation that demonstrate TNX-1500 prolongs non-human primate renal and heart allograft survival1,2.
1Lassiter, G., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate renal allograft survival. American Journal of Transplantation. April 3, 2023. https://doi.org/10.1016/j.ajt.2023.03.022
2Miura, S., et al. (2023) TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate cardiac allograft survival. American Journal of Transplantation. April 6, 2023. https://doi.org/10.1016/j.ajt.2023.03.025
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 topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation 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 third 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 third 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 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.
*All of Tonix’s product candidates are investigational new drugs (IND) or biologics and have not been approved for any indication. TNX-801, TNX-2900, TNX-3900 and TNX-4000 are in pre-IND stage of development and have not been approved for any indication.
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.
