Release – Energy Fuels Announces Q1-2023 Results, Including Net Income of $114.26 million, $143.61 million of Working Capital, $19.34 million of Uranium and Vanadium sales and Commencement of Development of Rare Earth Separation Capabilities in Utah

Research News and Market Data on UUUU

Conference Call and Webcast on May 9, 2023

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 V2Oon 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,
$000’s, except per share data20232022
Results of Operations:
   Uranium concentrates revenues$                           18,470$                                   —
   Vanadium concentrates revenues8712,412
   Total revenues19,6132,937
   Gross margin11,34745
   Operating loss(405)(10,213)
   Net income (loss)114,264(14,730)
   Basic and diluted net income (loss) per common share0.72(0.09)
As ofAs of
$000’sMarch 31, 2023December 31, 2022
Financial Position:
   Working capital$                         143,611$                         116,966
   Property, plant and equipment, net14,63512,662
   Mineral properties113,83483,539
  Current assets148,914135,590
   Total assets375,451273,947
  Current liabilities5,30318,624
   Total liabilities16,43829,538


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, investorinfo@energyfuels.com, www.energyfuels.com


Eagle Bulk Shipping (EGLE) – First-Quarter Results In Line With Recently Revised Estimates


Monday, May 08, 2023

Eagle Bulk Shipping Inc. (“Eagle”) is a US-based drybulk owner-operator focused on the Supramax/Ultramax mid-size asset class, which ranges from 50,000 and 65,000 deadweight tons in size; these vessels are equipped with onboard cranes allowing for the self-loading and unloading of cargoes, a feature which distinguishes them from the larger classes of drybulk vessels and provides for greatly enhanced flexibility and versatility- both with respect to cargo diversity and port accessibility. The Company transports a broad range of major and minor bulk cargoes around the world, including coal, grain, ore, pet coke, cement, and fertilizer. Eagle operates out of three offices, Stamford (headquarters), Singapore, and Hamburg, and performs all aspects of vessel management in-house including: commercial, operational, technical, and strategic.

Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Sensitivity to shipping rates leads to declines, as expected. Eagle Bulk Shipping reported a 43% decrease in net revenues versus last year despite additional operating days. The decline was due to a 53% decline in average TCE rates. Eagle’s financial results are highly leveraged to changes in shipping rates with a coverage position of only 65% of available days for the upcoming second quarter. 

The trend of rising operating costs seems to be abating. Cash operating costs have been rising in recent quarters but the growth appears to be slowing. Most notably was the decline in charter expenses (which we typically do do not model in). The decline was due to a reduction in chartered-in days (944 versus 960 last year) and an overall decline in charter hire rates related to the decline in drybulk market.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Ocugen (OCGN) – Moving Past Covaxin, Focusing On Gene Therapy and Pipeline Products


Monday, May 08, 2023

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Financial Report Includes Discontinuation Of Covaxin. Ocugen reported 1Q23 financial results of a loss of $16.5 million or $(0.07) per share, beating our estimate of a loss of $23.9 million or $(0.11) per share.  The difference was largely due to lower Research and Development spending at $9.6 million compared to our estimate of $15.9 million, attributed to the discontinuation of Covaxin development. Cash on hand at March 31 was $76.7 million, with the reduction in R&D expected to extend the cash runway into 1Q24.

Moving Beyond Covaxin. In view of recent changes in FDA guidance for monovalent COVID-19 vaccines, Ocugen has determined that Covaxin is no longer commercially viable and has discontinued development. We see this as a neutral to mild positive since the company had already announced that it would not continue development without outside funding. This should complete the shift to the gene therapy platform, NeoCart, and the inhaled vaccines.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Kratos Defense & Security (KTOS) – Solid 1Q23 Results; Growth Opportunities Expanding


Monday, May 08, 2023

Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms, and systems for United States National Security related customers, allies, and commercial enterprises. Kratos is changing the way breakthrough technologies for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research, and streamlined development processes. At Kratos, affordability is a technology, and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training and combat systems and next generation turbo jet and turbo fan engine development. For more information go to www.kratosdefense.com.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

1Q23 Results. Results came in at the high end of guidance. Revenue totaled $231.8 million, up 18.1% y-o-y. Organic growth was 12%. Adjusted EBITDA came in at $17 million, up from $13.8 million in 1Q22. GAAP EPS loss was $0.05 and adjusted EPS net income was $0.06, compared to a net loss of $0.13 and adjusted EPS of $0.04, respectively, a year ago. We had forecasted $220 million, $15.5 million, $(0.03), and $0.07, respectively.

Expanding Opportunity Set. Kratos’ opportunity set continues to expand. As part of the 5-year defense spend plan, the USAF has requested approximately $6 billion reflecting an increased prioritization with it being reported that the Air Force is looking to ultimately procure up to 2,000 drone systems. The Navy has been reported as stating they envision up to 60% of the future Navy Air Wing being comprised of drones.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Gray Television (GTN) – Core Advertising Is Outpacing Its Peers


Monday, May 08, 2023

Gray Television is a multimedia company headquartered in Atlanta, Georgia. We are the nation’s largest owner of top-rated local television stations and digital assets in the United States. Our television stations serve 113 television markets that collectively reach approximately 36 percent of US television households. This portfolio includes 80 markets with the top-rated television station and 100 markets with the first and/or second highest rated television station. We also own video program companies Raycom Sports, Tupelo Honey, PowerNation Studios and Third Rail Studios.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Solid Q1 results. The company reported quarterly revenue of  $801 million, 2.9% better than our estimate of $778.5 million, and adj. EBITDA of $162 million, which was in line with our estimate. Results are illustrated in Figure #1 Q1 Results. While all business segments reported stronger than expected revenues, political revenues of $8 million was the biggest surprise versus our estimate of $2 million. 

Favorable momentum. In spite of the macroeconomic headwinds, Q2 core advertising pacing is up a surprising 4%. We believe that a good portion of its positive advertising momentum is coming from revenue synergies. In addition, Auto advertising appears to be rebounding, pacing up double-digits. Looking ahead, the company is also likely to benefit from annual Net Retransmission revenue growth, when it renews the majority of its MVPD contracts later this year. Moreover, management expects Net Retransmission revenue growth to accelerate in 2024.  


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

E.W. Scripps (SSP) – Strong Retransmission Revenue Growth Offsets Some Headwinds


Monday, May 08, 2023

The E.W. Scripps Company (NASDAQ: SSP) is a diversified media company focused on creating a better-informed world. As one of the nation’s largest local TV broadcasters, Scripps serves communities with quality, objective local journalism and operates a portfolio of 61 stations in 41 markets. The Scripps Networks reach nearly every American through the national news outlets Court TV and Newsy and popular entertainment brands ION, Bounce, Defy TV, Grit, ION Mystery, Laff and TrueReal. Scripps is the nation’s largest holder of broadcast spectrum. Scripps runs an award-winning investigative reporting newsroom in Washington, D.C., and is the longtime steward of the Scripps National Spelling Bee. Founded in 1878, Scripps has held for decades to the motto, “Give light and the people will find their own way.”

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Solid Q1 results. The company reported quarterly revenue of $527.8 million, in-line with our estimate of $531.5 million. Adj. EBITDA of $75.9 million in the quarter was 6% lower than our estimate of $80.8 million, attributed to lower than expected stock based compensation. 

Favorable retransmission renewal. The company renewed 26% of its pay TV households in Q1, with a total of 75% of pay TV households up for renewal this year. As such, we expect strong Retrans revenue growth of 14% which should offset some of the headwinds from weak National and Direct Response advertising. Retransmission revenue is expected to be 50% of TV revenue and 30% of ttotal company revenue in 2023.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

GeoVax Labs, Inc. (GOVX) – Initiating Coverage With $6 Price Target


Monday, May 08, 2023

GeoVax Labs, Inc., a clinical-stage biotechnology company, develops human vaccines for infectious diseases and cancer in the United States and internationally. The company through its patented Modified Vaccinia Ankara-Virus Like Particle vaccine platform develops various vaccines. It is developing various vaccines that are in human clinical trials, and preclinical research and development phases, including vaccines against human immunodeficiency virus (HIV); Zika virus; malaria; and hemorrhagic fever viruses, such as Ebola, Sudan, Marburg, and Lassa, as well as therapeutic vaccines for chronic Hepatitis B infections and cancers. The company has collaboration and partnership agreements with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health; the HIV Vaccines Trial Network; Centers for Disease Control and Prevention; United States Army Research Institute of Infectious Disease; U.S. Naval Research Laboratory; Emory University; University of Pittsburgh; Georgia State University Research Foundation; Peking University; University of Texas Medical Branch; the Institute of Human Virology at the University of Maryland; the Scripps Research Institute; the Burnet Institute; American Gene Technologies, Inc.; Viamune, Inc.; Vaxeal Holding SA; CaroGen Corporation; Virometix AG; and Leidos, Inc. GeoVax Labs, Inc. was founded in 2001 and is based in Smyrna, Georgia.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Initiating Coverage of GOVX. GeoVax Labs is developing gene therapies, immunotherapies, and vaccines for cancer and infectious diseases. Gedeptin, its lead cancer product, is a gene-directed therapy for cancer.  The treatment delivers a gene to the cancer cells that converts an inactive prodrug into an active cytotoxic drug within the tumor cells. 

Gedeptin Uses A Proprietary Gene Delivery Technology. Gedeptin uses an adenovirus vector to deliver a gene to cancer cells that converts an inactive prodrug into an active cytotoxic drug within the tumor cells. This increases the drug’s potency inside the cancer cells while avoiding healthy tissue. Gedeptin is currently in a Phase 1/2 trial for advanced head and neck cancers, and has been granted Orphan Drug Designation for oral and pharyngeal cancers.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

CoreCivic, Inc. (CXW) – 1Q23 Post Call Commentary


Monday, May 08, 2023

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by government agencies in the United States. We have been a flexible and dependable partner for government for nearly 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

May 11th. With Title 42 expected to end May 11th, CoreCivic is well positioned to capitalize on any increase in ICE detainee populations. The key unanswered question is if the Biden Administration will enforce existing immigration laws. Recent comments by Secretary of State Blinken and Secretary of Homeland Security Mayorkas suggests the federal government will, but it remains to be seen.

Well Positioned. CoreCivic is well positioned to assist the government with any additional demand for beds and services. The Company has “thousands” of beds at existing facilities that could be used and seven idle facilities that could be restarted. The Company has hired staff in anticipation of rising populations.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

AI is Exciting – and an Ethical Minefield

Four Essential Reads on the Risks and Concerns Over Artificial Intelligence

If you’re like me, you’ve spent a lot of time over the past few months trying to figure out what this AI thing is all about. Large-language models, generative AI, algorithmic bias – it’s a lot for the less tech-savvy of us to sort out, trying to make sense of the myriad headlines about artificial intelligence swirling about.

But understanding how AI works is just part of the dilemma. As a society, we’re also confronting concerns about its social, psychological and ethical effects. Here we spotlight articles about the deeper questions the AI revolution raises about bias and inequality, the learning process, its impact on jobs, and even the artistic process.

Ethical Debt

When a company rushes software to market, it often accrues “technical debt”: the cost of having to fix bugs after a program is released, instead of ironing them out beforehand.

There are examples of this in AI as companies race ahead to compete with each other. More alarming, though, is “ethical debt,” when development teams haven’t considered possible social or ethical harms – how AI could replace human jobs, for example, or when algorithms end up reinforcing biases.

Casey Fiesler, a technology ethics expert at the University of Colorado Boulder, wrote that she’s “a technology optimist who thinks and prepares like a pessimist”: someone who puts in time speculating about what might go wrong.

That kind of speculation is an especially useful skill for technologists trying to envision consequences that might not impact them, Fiesler explained, but that could hurt “marginalized groups that are underrepresented” in tech fields. When it comes to ethical debt, she noted, “the people who incur it are rarely the people who pay for it in the end.”

Is Anybody There?

AI programs’ abilities can give the impression that they are sentient, but they’re not, explained Nir Eisikovits, director of the Applied Ethics Center at the University of Massachusetts Boston. “ChatGPT and similar technologies are sophisticated sentence completion applications – nothing more, nothing less,” he wrote.

But saying AI isn’t conscious doesn’t mean it’s harmless.

“To me,” Eisikovits explained, “the pressing question is not whether machines are sentient but why it is so easy for us to imagine that they are.” Humans easily project human features onto just about anything, including technology. That tendency to anthropomorphize “points to real risks of psychological entanglement with technology,” according to Eisikovits, who studies AI’s impact on how people understand themselves.

Considering how many people talk to their pets and cars, it shouldn’t be a surprise that chatbots can come to mean so much to people who engage with them. The next steps, though, are “strong guardrails” to prevent programs from taking advantage of that emotional connection.

Putting Pen to Paper

From the start, ChatGPT fueled parents’ and teachers’ fears about cheating. How could educators – or college admissions officers, for that matter – figure out if an essay was written by a human or a chatbot?

But AI sparks more fundamental questions about writing, according to Naomi Baron, an American University linguist who studies technology’s effects on language. AI’s potential threat to writing isn’t just about honesty, but about the ability to think itself.

Baron pointed to novelist Flannery O’Connor’s remark that “I write because I don’t know what I think until I read what I say.” In other words, writing isn’t just a way to put your thoughts on paper; it’s a process to help sort out your thoughts in the first place.

AI text generation can be a handy tool, Baron wrote, but “there’s a slippery slope between collaboration and encroachment.” As we wade into a world of more and more AI, it’s key to remember that “crafting written work should be a journey, not just a destination.”

The Value of Art

Generative AI programs don’t just produce text, but also complex images – which have even captured a prize or two. In theory, allowing AI to do nitty-gritty execution might free up human artists’ big-picture creativity.

Not so fast, said Eisikovits and Alec Stubbs, who is also a philosopher at the University of Massachusetts Boston. The finished object viewers appreciate is just part of the process we call “art.” For creator and appreciator alike, what makes art valuable is “the work of making something real and working through its details”: the struggle to turn ideas into something we can see.

This story is a roundup of articles originally puplished in The Conversation. It was compiled by

Molly Jackson, the Religion and Ethics Editor at The Conversation. It includes work from Alec Stubbs, Postdoctoral Fellow in Philosophy, UMass Boston. Casey Fiesler, Associate Professor of Information Science, University of Colorado Boulder. Naomi S. Baron, Professor Emerita of Linguistics, American University. And, Nir Eisikovits, Professor of Philosophy and Director, Applied Ethics Center, UMass Boston. It was reprinted with permission.

Can You Prepare for Hyperinflation?

Hyperinflation, Can Investors Protect Themselves?

Inflation in Argentina so far in 2023 is running at 126.4%. Meanwhile, its GDP has declined by 3.1%. This certainly meets the definition of hyperinflation. Can this situation occur in the U.S. economy? Hyperinflation is when prices of goods and services in the economy run up rapidly; at the same time, it causes the value of the nation’s currency to fall rapidly. It’s a devastating phenomenon that has serious consequences for businesses, investors, and households. Below we explore the causes of hyperinflation, its effects on the economy, and some ways to protect investable assets against it.

Causes of Hyperinflation

Hyperinflation can be caused by a variety of factors, but one ingredient that is most common is excessive money printing by the country’s central bank. When a central bank allows excessive cash in circulation, especially if it is during a period of low or negative growth, natural economic forces that occur when there is an abundance of currency chasing the same or fewer goods, serves to drive up prices and down currency values. This inflation can quickly spiral out of control, leading to hyperinflation. Other causes could include shortages of goods or services driving prices up as demand outstrips available supply.

Effects on the Economy

Excessive inflation is not good for anyone that holds the impacted currency. Businesses can command higher prices, but they will also be paying higher prices to run their business and receiving payment with notes with far less purchasing power. This is because hyperinflation increases costs for labor and raw materials, weighing down profit margins. Less obvious, but certainly adding to the hardship, is that businesses may have trouble securing financing and loans during hyperinflation; this can limit their ability to function or grow.

For households and individuals, hyperinflation also rapidly decreases purchasing power, as prices for goods and services jump up. This lowers living standards in the country as people are forced to pay more for the same goods and services. Additionally, hyperinflation can lead to a loss of confidence in the currency. Behavior including the belief that items should be purchased now because they will be more expensive tomorrow leads to hoarding and other actions that create shortages and drives up prices even further.

How Some Prepare for Hyperinflation

Hyperinflation is rare, yet, once the wheels start turning, such as they did in Venezuela in 2016, or Germany in 1923, it is important for businesses and individuals to take steps to prepare for the possibility. Here are ways that people have prepared for excessive inflation in their native currency.

Diversify Your Investments: While some believe it is always prudent to stay widely diversified, it may offer even more protection when the economy goes through the turmoil of excessive inflation. Preparing in this way means spreading your investments across a variety of asset classes, such as stocks, bonds, real estate, and commodities. This will help by avoiding any one particular asset class that gets hit hard. Keep in mind, stocks are often a good hedge against moderate inflation, and precious metals have historically been looked to for protection in times of extreme inflation. Earnings of companies that export are not expected to suffer as much as importers.

Hold Some Assets Denominated in Other Currencies: This can include established digital currencies, foreign stocks, bonds, that are not denominated in your own home currency. By holding assets denominated in other currencies, you can protect yourself from its devaluation versus others.

Invest in Hard Assets: Hard assets, such as gold and silver, land, and even tools can be a good way to protect yourself or your business from hyperinflation. These assets have intrinsic value and can retain their value even if the currency they are denominated in loses value. Remember that if inflation remains, it is likely to cost more in the coming months for the same piece of office equipment that helps your business run more efficiently.

Cryptocurrencies: Keeping within the guidelines of diversification, more established tokens such as bitcoin and ether are considered by some to help protect from hyperinflation. A word of caution, cryptocurrencies have little history against currency devaluation and inflation. The theory however is these digital currencies are decentralized and not subject to the same inflationary pressures as fiat currencies.

Take Away

In 2018 inflation in Venezuela exceeded 1,000,000%, proving, when the recipe for higher prices is in place, the unimaginable can happen.  

While there is no consumer or investor that can proactively impact a rising price freight train, if hyperinflation is expected, there are steps one can take to reduce the negative impacts. These financial steps can be as simple as buying things today that you expect to need later, and more substantially diversifying your portfolio toward hard assets, companies that export to countries not experiencing inflation, and even bonds with either short maturities or an inflation factor as part of the return.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.nasdaq.com/articles/argentina-inflation-seen-at-126.4-in-2023-central-bank-poll-shows

https://www.pbs.org/wgbh/commandingheights/shared/minitext/ess_germanhyperinflation.html#:~:text=In%201923%2C%20at%20the%20most,surprise%20by%20the%20financial%20tornado.

https://www.theatlantic.com/business/archive/2012/03/the-hyperinflation-hype-why-the-us-can-never-be-weimar/254715/

The Week Ahead –  Inflation (CPI), Inflation (PPI), and Fed Governors’ Words of Wisdom

The Market is Deciding if the Fed is Finished or Not, Here’s How this Week Will Help

Two key inflation reports and quite a few Fed governors are coming out of the blackout period, removing the gag and sharing their thoughts on the state of the economy and monetary policy. Last Friday’s strong US Jobs report has left many market participants looking for a clearer sign that the Fed will take a neutral stance. The two inflation reports and Fed governor addresses may help make clear the Fed’s next “data dependent” step.  

Monday 5/8

•             10:00 AM ET, Wholesale Inventories (preliminary), this is the second estimate for March wholesale inventories. It is expected to print at a 0.1 percent build-up, unchanged from the first estimate. The report measures the dollar value of sales made and inventories held by wholesalers.

Tuesday 5/9

•             House Speaker Kevin McCarthy will meet with President Joe Biden to discuss the debt limit. The meeting comes three weeks before the U.S. is projected to run out of money to pay its bills.

•             6:00 AM ET, The Small Business Optimism Index has been below, at times deeply below, the historical average of 98. The April consensus is 89.7 versus 90.1 in March.

•             8:30 AM ET, Phillip Jefferson took office as a member of the Board of Governors of the Federal Reserve System in May 2022. While he is relatively unknown, he may begin to play a larger part as he is considered a favorite for Fed Vice Chair, with Biden set to nominate Jefferson for the seat vacated by Lael Brainard seat.

•             12:05 AM ET, John Williams is the President of the New York Federal Reserve. The New York Fed President takes the role of Vice Chair of the FOMC, the seat is a permanent voting member (outside the rotation).

Wednesday 5/10

•             8:30 AM ET, Consumer Price Index (CPI) for April is expected to show that core prices are continuing at the same pace of a monthly increase of 0.4 percent. The headline number is also expected to rise 0.4 percent after March’s 0.1 percent increase, which was below expectations – remember, energy prices spiked last month. Annual rates, which in March were 5.0 percent headline and 5.6 percent for the core, are expected at 5.0 and 5.5 percent, showing little or no improvement.

•             2:00 PM, the Treasury Statement for April is expected to show a $410.0 billion surplus. That would compare with a $308.2 billion surplus in April a year-ago and a deficit in March this year of $378.1 billion. April, tax month, is the seventh month of the government’s fiscal year.

Thursday 5/11

•             8:30 AM ET, the Producer Price Index (PPI), after falling 0.5 percent in March, is expected to rise 0.3 percent in April. The annual rate ending April is forecast to be 2.5 percent, down slightly from March’s 2.7 percent. April’s ex-food ex-energy rate is seen at 0.2 percent on the month and 3.3 percent on the year versus March’s monthly 0.1 percent decline and plus 3.4 percent yearly rate.

•             7:45 AM ET, Christopher Waller is a member of the St. Louis Federal Reserve Board of Governors. He is a CBDC advocate. Along with Bullard and Mester, Waller is considered to be among the Fed hawks.

•             4:30 AM ET, The Fed’s balance sheet is a weekly report presenting a consolidated balance sheet for all 12 Reserve Banks. It lists factors supplying reserves into the banking system and factors absorbing reserves from the system. The official name for the report is Factors Affecting Reserve Balances, otherwise known as the “H.4.1” report. This report has taken on renewed interest as it is the only place to get information on quantitative tightening moves, and the impact of new measures taken to secure troubled banks.

Friday 5/12

•             8:30 PM ET, Import/Export Prices. Import Prices, an inflation harbinger is expected to rise 0.3 percent for April, this would end nine straight declines. Export prices are expected to rise 0.2 percent.

•             10:00 PM ET, Consumer Sentiment looking at the first indication for May, which in April fell 1.5 points to 63.5, is expected to fall another half point to 63.0.

•             7:45 PM ET, a late day address by St. Louis Fed Chair James Bullard.

What Else

Investment roadshows are like getting a front-row seat to information direct from management’s mouth. The most useful investor information often comes from the unplanned responses to questions during the roadshow – either asked by you, or other interested investors.

Noble Capital Markets has a growing, interesting calendar of roadshows during the week and month. Some are in cities that are paid less attention to. These include Entravision in Kansas City, MO, on May 9 (lunch). Entravision will again be presenting on May 10 in ST. Louis (lunch). Also on May 10, Salem Media will be in New York (lunch). For more details, and a complete list of roadshows and cities, Click here.

Paul Hoffman

Managing Editor, Channelchek

Sources:

https://www.federalreserve.gov/newsevents/calendar.htm

https://www.federalreserve.gov/newsevents/calendar.htm

https://www.econoday.com/

https://www.channelchek.com/news-channel/noble_on_the_road___noble_capital_markets_in_person_roadshow_series

Release – Ocugen Provides Business Update With First Quarter 2023 Financial Results

Research News and Market Data on OCGN

May 5, 2023

Conference Call and Webcast Today at 8:30 a.m. ET

  • 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.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com 

Release – Alvopetro Announces April 2023 Sales Volumes, an Operational Update and Timing of Q1 2023 Results and Earnings Call

Research News and Market Data on ALVOF

May 04, 2023

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:

Date: May 11, 2023Time: 8:00 AM Mountain/10:00 AM EasternLink:  https://us06web.zoom.us/j/89193926478Dial-in numbers: https://us06web.zoom.us/u/kcmVqG8cd9Webinar ID: 891 9392 6478

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 socialmedia@alvopetro.com.

Corporate Presentation

Alvopetro’s updated corporate presentation is available on our website at:http://www.alvopetro.com/corporate-presentation

Social Media

Follow Alvopetro on our social media channels at the following links:

Twitter – https://twitter.com/AlvopetroEnergyInstagram – https://www.instagram.com/alvopetro/LinkedIn – https://www.linkedin.com/company/alvopetro-energy-ltdYouTube –https://www.youtube.com/channel/UCgDn_igrQgdlj-maR6fWB0w

Alvopetro Energy Ltd.’s vision 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.

SOURCE Alvopetro Energy Ltd.