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Release – Tonix Pharmaceuticals Reports First Quarter 2023 Financial Results and Operational Highlights

Posted on May 8, 2023May 8, 2023 by [email protected]

Research News and Market Data on TNXP

May 08, 2023 7:00am EDT

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

Posted on May 8, 2023May 8, 2023 by [email protected]

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 V₂O₅on 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

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

Posted on May 5, 2023May 5, 2023 by [email protected]

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
[email protected]

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

Posted on May 5, 2023May 5, 2023 by [email protected]

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 [email protected].

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.

Release – Cocrystal Pharma Presents New Data from its CC-42344 Phase 1 Influenza A Study at the 7th Annual ISIRV Antiviral Group Conference

Posted on May 5, 2023May 5, 2023 by [email protected]

Research News and Market Data on COCP

MAY 04, 2023

BOTHELL, Wash., May 04, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces that new data from its CC-42344 Phase 1 influenza A Study was presented today by Sam Lee, Ph.D., President and co-CEO, at the 7^th Annual International Society for Influenza and Other Respiratory Virus Diseases’ (ISIRV) Antiviral Group Conference.

“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.

Cautionary Note Regarding Forward-Looking Statements

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.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
[email protected]

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
[email protected]

# # #

Source: Cocrystal Pharma, Inc.

Released May 4, 2023

Release – Entravision Communications Corporation Reports First Quarter 2023 Results

Posted on May 5, 2023May 5, 2023 by [email protected]

Research News and Market Data on EVC

05/04/2023

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

Kimberly Esterkin
ADDO Investor Relations
310-829-5400
[email protected]Source: Entravision Communications Corporation

Release – Onconova Therapeutics To Provide Corporate Update And Announce First Quarter 2023 Financial Results On May 15, 2023

Posted on May 5, 2023May 5, 2023 by [email protected]

Research News and Market Data ONTX

May 04, 2023

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).

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

Forward Looking Statements

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

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

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

Release – Salem Media Group Schedules First Quarter 2023 Earnings Release and Teleconference

Posted on May 5, 2023May 5, 2023 by [email protected]

Research News and Market Data on SALM

May 04, 2023 1:53pm EDT

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230501005710/en/

Evan D. Masyr
Executive Vice President and Chief
Financial Officer
(805) 384-4512
[email protected]

Source: Salem Media Group, Inc.

Released May 4, 2023

Release – Comtech Welcomes Aarna Networks as New EVOKE Technology Partner

Posted on May 4, 2023May 4, 2023 by [email protected]

Research News and Market Data on CMTL

May 4, 2023 9:04 AM

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.

PCMTL

View source version on businesswire.com: https://www.businesswire.com/news/home/20230503006108/en/

Investor Relations

Robert Samuels

631-962-7102

[email protected]

Media Contact

Jamie Clegg

480-532-2523

[email protected]

Release – PDS Biotechnology Announces Conference Call and Webcast for First Quarter 2023 Financial Results

Posted on May 4, 2023May 4, 2023 by [email protected]

Research News and Market Data on PDSB

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.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

Media Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
[email protected]

Bill Borden
Phone: +1 (732) 910-1620
[email protected]

Release – Tonix Pharmaceuticals Announces IND Clearance for TNX-1500 (anti-CD40L mAb) for the Prevention of Organ Rejection in Patients Receiving a Kidney Transplant

Posted on May 4, 2023May 4, 2023 by [email protected]

Research News and Market Data on TNXP

May 04, 2023 7:00am EDT

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 tolerated^1,2.

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 survival^1,2.

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

Contacts

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

Maddie Stabinski (media)
Russo Partners
[email protected]
(212) 845-4273

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

Source: Tonix Pharmaceuticals Holding Corp.

Released May 4, 2023

Release – CoreCivic Reports First Quarter 2023 Financial Results

Posted on May 4, 2023May 4, 2023 by [email protected]

Research News and Market Data on CXW

May 3, 2023

Updates 2023 Full Year Guidance

BRENTWOOD, Tenn., May 03, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (the Company) announced today its financial results for the first quarter of 2023.

Damon T. Hininger, CoreCivic’s President and Chief Executive Officer, said, “We are pleased to report first quarter results that were in line with our expectations, while we continue to operate through a challenging labor market and execute on our long-term capital allocation strategy. During the first quarter, we generated $73.7 million of EBITDA that, along with existing liquidity, enabled us to repay in full the $153.8 million outstanding balance of our 4.625% Senior Notes that were scheduled to mature on May 1, 2023. We also continued to execute on our share repurchase program during the quarter by repurchasing 2.5 million shares, representing an additional 2% of our outstanding shares, at a total cost of $24.9 million.

Hininger continued, “We’re also proud to have recently released our fifth Environmental, Social and Governance (ESG) Report. The ESG report details the ways we delivered reentry and vocational programming designed to prepare those in our care for long-lasting success upon reentry to their communities during 2022, a mission that our organization has been carrying out for more than 40 years. I hope you have an opportunity to review our latest ESG report to learn more about CoreCivic and the important services we provide. We are proud of our history and our accomplishments that truly help individuals in our care change their lives for the better primarily through the strength and volume of our evidence-based programs.”

Financial Highlights – First Quarter 2023

Total revenue of $458.0 million
- CoreCivic Safety revenue of $417.7 million
- CoreCivic Community revenue of $26.4 million
- CoreCivic Properties revenue of $13.8 million
Net Income of $12.4 million
Diluted earnings per share of $0.11
Adjusted Diluted EPS of $0.13
Normalized Funds From Operations per diluted share of $0.34
EBITDA of $73.7 million

First Quarter 2023 Financial Results Compared With First Quarter 2022

Net income in the first quarter of 2023 totaled $12.4 million, or $0.11 per diluted share, compared with net income in the first quarter of 2022 of $19.0 million, or $0.16 per diluted share. Adjusted for special items, adjusted net income in the first quarter of 2023 was $14.7 million, or $0.13 per diluted share (Adjusted Diluted EPS), compared with adjusted net income in the first quarter of 2022 of $17.4 million, or $0.14 per diluted share. Special items for each period are presented in detail in the calculation of Adjusted Diluted EPS in the Supplemental Financial Information following the financial statements presented herein.

The $0.01 per share decline in Adjusted Diluted EPS occurred despite transitioning to the previously announced contract with the state of Arizona at our 3,060-bed La Palma Correctional Center in Arizona, the expiration of our contract with the Federal Bureau of Prisons (BOP) at the McRae Correctional Facility on November 30, 2022, and ongoing labor market pressures, including above average wage inflation. We substantially completed the transition of inmate populations at the La Palma facility by the end of 2022, but we continued to incur elevated operating expenses during the first quarter of 2023 due to ongoing efforts to attract and retain local staff at the facility. Despite the expiration of the contract with the BOP at the McRae facility, a facility we sold to the state of Georgia in 2022, our renewal rate on owned and controlled facilities remains high at 94% over the previous five years. We believe our renewal rate on existing contracts remains high due to a variety of reasons including the aged and constrained supply of available beds within the U.S. correctional system, our ownership of the majority of the beds we operate, the value our government partners place in the wide range of recidivism-reducing programs we offer to those in our care, and the cost effectiveness of the services we provide.

Earnings before interest, taxes, depreciation and amortization (EBITDA) was $73.7 million in the first quarter of 2023, compared with $83.0 million in the first quarter of 2022. Adjusted EBITDA was $73.7 million in the first quarter of 2023, compared with $80.8 million in the first quarter of 2022. Adjusted EBITDA of $80.8 million in the prior year quarter excludes a net gain on sale of real estate assets. Adjusted EBITDA decreased from the prior year quarter primarily due to the previously mentioned transition of offender populations at our La Palma Correctional Center, which resulted in a reduction in EBITDA of $7.4 million, and the expiration of our BOP contract at the McRae Correctional Facility in November 2022, which resulted in a reduction in EBITDA of $2.3 million from the first quarter of 2022 to the first quarter of 2023. Due to an improving labor market, we achieved higher staffing levels in the first quarter of 2023 than in the prior year quarter; however, we incurred higher wage rates than in the prior year quarter in order to attract and retain facility staff in the challenging labor market. We also incurred higher travel expenses in order to augment staffing levels at multiple facilities. We believe these investments in staffing are positioning us to manage the increased number of residents we anticipate at our facilities once the remaining occupancy restrictions attributable to COVID-19 are removed, most notably Title 42, a policy that denies entry at the United States border to asylum-seekers and anyone crossing the border without proper documentation or authority in an effort to contain the spread of COVID-19. Title 42 is currently scheduled to end in May 2023. Despite the difficult labor market, we have been able to reduce certain labor-related expenses, such as registry nursing and temporary incentives, which moderated during the first quarter of 2023 compared with the first quarter of 2022.

Funds From Operations (FFO) was $36.6 million, or $0.32 per diluted share, in the first quarter of 2023, compared to $41.5 million, or $0.34 per diluted share, in the first quarter of 2022. Normalized FFO, which excludes special items, was $38.9 million, or $0.34 per diluted share, in the first quarter of 2023, compared with $41.5 million, or $0.34 per diluted share, in the first quarter of 2022. Normalized FFO was impacted by the same factors that affected Adjusted EBITDA.

Adjusted Net Income, EBITDA, Adjusted EBITDA, FFO, and Normalized FFO, and, where appropriate, their corresponding per share amounts, are measures calculated and presented on the basis of methodologies other than in accordance with generally accepted accounting principles (GAAP). Please refer to the Supplemental Financial Information and the note following the financial statements herein for further discussion and reconciliations of these measures to net income, the most directly comparable GAAP measure.

Asset Dispositions and Assets Held for Sale

During the third quarter of 2022, we began marketing for sale our Roth Hall Residential Reentry Center and the Walker Hall Residential Reentry Center, both of which are located in Philadelphia, Pennsylvania and reported in our CoreCivic Properties segment. The properties were classified as held for sale as of March 31, 2023 and December 31, 2022. A purchase and sale agreement for these two Philadelphia properties was executed in March 2023 and the properties were sold on May 2, 2023, generating net sales proceeds of $5.8 million, which approximated the carrying value of the properties. We are also marketing for sale a residential reentry center in Denver, Colorado with a carrying value of $1.2 million and reported in our CoreCivic Community segment, which was also classified as held for sale as of March 31, 2023.

Share Repurchases

On May 12, 2022, our Board of Directors approved a share repurchase program authorizing the Company to repurchase up to $150.0 million of our common stock. On August 2, 2022, our Board of Directors authorized an increase in our share repurchase program of up to an additional $75.0 million in shares of our common stock, or a total of up to $225.0 million. During the first quarter of 2023, we repurchased 2.5 million shares of our common stock at an aggregate purchase price of $24.9 million, excluding fees, commissions and other costs related to the repurchases. Since the share repurchase program was authorized, through March 31, 2023, we have repurchased a total of 9.1 million shares at an aggregate price of $99.4 million under this share repurchase program.

As of March 31, 2023, we had $125.6 million remaining under the share repurchase program authorized by the Board of Directors. Additional repurchases of common stock will be made in accordance with applicable securities laws and may be made at management’s discretion within parameters set by the Board of Directors from time to time in the open market, through privately negotiated transactions, or otherwise. The share repurchase program has no time limit and does not obligate us to purchase any particular amount of our common stock. The authorization for the share repurchase program may be terminated, suspended, increased or decreased by our Board of Directors in its discretion at any time.

Debt Repayments

On December 22, 2022, we delivered an irrevocable notice to the trustee of the holders of the 4.625% Senior Notes that we elected to redeem in full the 4.625% Senior Notes that remained outstanding on February 1, 2023. The 4.625% Senior Notes were redeemed on February 1, 2023 at a redemption price equal to 100% of the principal amount of the outstanding 4.625% Senior Notes, which amounted to $153.8 million, plus accrued and unpaid interest to, but not including, the redemption date. We used a combination of cash on hand and available capacity under our Revolving Credit Facility to fund the redemption. During the first quarter of 2023, we reduced our total debt balance by $146.2 million, or by $48.2 million net of the change in cash. Following the redemption of the 4.625% Senior Notes, we have no debt maturities until 2026.

2023 Financial Guidance

Based on current business conditions, we are providing the following update to our financial guidance for the full year 2023:

	Guidance Full Year 2023	Prior Guidance Full Year 2023
Net income	$51.2 million to $63.2 million	$58.0 million to $75.0 million
Adjusted net income	$53.5 million to $65.5 million	$58.0 million to $75.0 million
Diluted EPS	$0.44 to $0.55	$0.50 to $0.65
Adjusted Diluted EPS	$0.46 to $0.57	$0.50 to $0.65
FFO per diluted share	$1.29 to $1.40	$1.35 to $1.50
Normalized FFO per diluted share	$1.31 to $1.42	$1.35 to $1.50
EBITDA	$291.3 million to $301.3 million	$298.5 million to $313.5 million
Adjusted EBITDA	$293.6 million to $303.6 million	$298.5 million to $313.5 million

Financial guidance has been updated to reflect a favorable $0.01 per share variance to our internal forecast for the first quarter of 2023, offset by $0.04 per share to reflect the non-renewal of our lease with the state of Oklahoma at our North Fork Correctional Facility expiring June 30, 2023, which we previously disclosed on April 24, 2023. In addition, we continue to negotiate in good faith with the state of Oklahoma for the renewal of our contract to manage our Davis Correctional Facility, which also expires June 30, 2023, and operated at a loss during 2022 and the first quarter of 2023. However, we have not yet been able to reach acceptable terms. Our updated guidance was further reduced by $0.03 per share to reflect the potential transition of inmate populations out of the Davis Correctional Facility during the second quarter of 2023 and idle operations during the second half of the year, which we did not contemplate in our previous forecast. If we are able to reach acceptable terms on a new agreement, the $0.03 per share reduction will be avoided, as we would exceed our forecast by approximately $0.02 per share during the second quarter by avoiding the transition, and we would further exceed our guidance during the second half of 2023, the magnitude of which would depend on the terms of a new agreement.

During 2023, we expect to invest $64.0 million to $67.0 million in capital expenditures, consisting of $36.0 million to $37.0 million in maintenance capital expenditures on real estate assets, $25.0 million to $26.0 million for maintenance capital expenditures on other assets and information technology, and $3.0 million to $4.0 million for other capital investments. These capital expenditure amounts are unchanged from our previous guidance.

Supplemental Financial Information and Investor Presentations

We have made available on our website supplemental financial information and other data for the first quarter of 2023. Interested parties may access this information through our website at http://ir.corecivic.com/ under “Financial Information” of the Investors section. We do not undertake any obligation and disclaim any duties to update any of the information disclosed in this report.

Management may meet with investors from time to time during the second quarter of 2023. Written materials used in the investor presentations will also be available on our website beginning on or about May 19, 2023. Interested parties may access this information through our website at http://ir.corecivic.com/ under “Events & Presentations” of the Investors section.

Conference Call, Webcast and Replay Information

We will host a webcast conference call at 10:00 a.m. central time (11:00 a.m. eastern time) on Thursday, May 4, 2023, which will be accessible through the Company’s website at www.corecivic.com under the “Events & Presentations” section of the “Investors” page.

To participate via telephone and join the call live, please register in advance here https://register.vevent.com/register/BI6394fffe952b47d497a2735e53d08f32. Upon registration, telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a unique passcode.

About CoreCivic

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 one of the largest prison operators in the United States. We have been a flexible and dependable partner for government for 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.

Forward-Looking Statements

This press release contains statements as to our beliefs and expectations of the outcome of future events that are “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. These include, but are not limited to, the risks and uncertainties associated with: (i) changes in government policy, legislation and regulations that affect utilization of the private sector for corrections, detention, and residential reentry services, in general, or our business, in particular, including, but not limited to, the continued utilization of our correctional and detention facilities by the federal government, including as a consequence of the United States Department of Justice, or DOJ, not renewing contracts as a result of President Biden’s Executive Order on Reforming Our Incarceration System to Eliminate the Use of Privately Operated Criminal Detention Facilities, or the Private Prison EO, impacting utilization primarily by the BOP and the United States Marshals Service, and the impact of any changes to immigration reform and sentencing laws (we do not, under longstanding policy, lobby for or against policies or legislation that would determine the basis for, or duration of, an individual’s incarceration or detention); (ii) our ability to obtain and maintain correctional, detention, and residential reentry facility management contracts because of reasons including, but not limited to, sufficient governmental appropriations, contract compliance, negative publicity and effects of inmate disturbances; (iii) changes in the privatization of the corrections and detention industry, the acceptance of our services, the timing of the opening of new facilities and the commencement of new management contracts (including the extent and pace at which new contracts are utilized), as well as our ability to utilize available beds; (iv) general economic and market conditions, including, but not limited to, the impact governmental budgets can have on our contract renewals and renegotiations, per diem rates, and occupancy; (v) fluctuations in our operating results because of, among other things, changes in occupancy levels; competition; contract renegotiations or terminations; inflation and other increases in costs of operations, including a continuing rise in labor costs; fluctuations in interest rates and risks of operations; (vi) the duration of the federal government’s denial of entry at the United States southern border to asylum-seekers and anyone crossing the southern border without proper documentation or authority in an effort to contain the spread of COVID-19, a policy known as Title 42 (Title 42 is expected to end May 11, 2023, when President Biden has decided to lift the public health emergency for COVID-19, although its termination may be subject to ongoing litigation, the outcome of which is unclear. Most recently, on December 27, 2022, the Supreme Court granted a stay on the cessation of Title 42, while it considers an appeal by a group of states to continue the expulsions.); (vii) our ability to successfully identify and consummate future development and acquisition opportunities and realize projected returns resulting therefrom; (viii) our ability to have met and maintained qualification for taxation as a real estate investment trust, or REIT, for the years we elected REIT status; and (ix) the availability of debt and equity financing on terms that are favorable to us, or at all. Other factors that could cause operating and financial results to differ are described in the filings we make from time to time with the Securities and Exchange Commission.

We take no responsibility for updating the information contained in this press release following the date hereof to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events or for any changes or modifications made to this press release or the information contained herein by any third-parties, including, but not limited to, any wire or internet services.

NOTE TO SUPPLEMENTAL FINANCIAL INFORMATION

Adjusted Net Income, EBITDA, Adjusted EBITDA, FFO, and Normalized FFO, and, where appropriate, their corresponding per share metrics are non-GAAP financial measures. The Company believes that these measures are important operating measures that supplement discussion and analysis of the Company’s results of operations and are used to review and assess operating performance of the Company and its properties and their management teams. The Company believes that it is useful to provide investors, lenders and security analysts disclosures of its results of operations on the same basis that is used by management.

FFO, in particular, is a widely accepted non-GAAP supplemental measure of performance of real estate companies, grounded in the standards for FFO established by the National Association of Real Estate Investment Trusts (NAREIT). NAREIT defines FFO as net income computed in accordance with GAAP, excluding gains (or losses) from sales of property and extraordinary items, plus depreciation and amortization of real estate and impairment of depreciable real estate and after adjustments for unconsolidated partnerships and joint ventures calculated to reflect funds from operations on the same basis. As a company with extensive real estate holdings, we believe FFO and FFO per share are important supplemental measures of our operating performance and believe they are frequently used by securities analysts, investors and other interested parties in the evaluation of REITs and other real estate operating companies, many of which present FFO and FFO per share when reporting results. EBITDA, Adjusted EBITDA, and FFO are useful as supplemental measures of performance of the Company’s properties because such measures do not take into account depreciation and amortization, or with respect to EBITDA, the impact of the Company’s tax provision and financing strategies. Because the historical cost accounting convention used for real estate assets requires depreciation (except on land), this accounting presentation assumes that the value of real estate assets diminishes at a level rate over time. Because of the unique structure, design and use of the Company’s properties, management believes that assessing performance of the Company’s properties without the impact of depreciation or amortization is useful. The Company may make adjustments to FFO from time to time for certain other income and expenses that it considers non-recurring, infrequent or unusual, even though such items may require cash settlement, because such items do not reflect a necessary or ordinary component of the ongoing operations of the Company. Normalized FFO excludes the effects of such items. The Company calculates Adjusted Net Income by adding to GAAP Net Income expenses associated with the Company’s debt repayments and refinancing transactions, and certain impairments and other charges that the Company believes are unusual or non-recurring to provide an alternative measure of comparing operating performance for the periods presented.

Other companies may calculate Adjusted Net Income, EBITDA, Adjusted EBITDA, FFO, and Normalized FFO differently than the Company does, or adjust for other items, and therefore comparability may be limited. Adjusted Net Income, EBITDA, Adjusted EBITDA, FFO, and Normalized FFO and, where appropriate, their corresponding per share measures are not measures of performance under GAAP, and should not be considered as an alternative to cash flows from operating activities, a measure of liquidity or an alternative to net income as indicators of the Company’s operating performance or any other measure of performance derived in accordance with GAAP. This data should be read in conjunction with the Company’s consolidated financial statements and related notes included in its filings with the Securities and Exchange Commission.

Contact:	Investors: Cameron Hopewell – Managing Director, Investor Relations – (615) 263-3024
	Financial Media: David Gutierrez, Dresner Corporate Services – (312) 780-7204

Release – Schwazze Announces First Quarter Earnings Call

Posted on May 3, 2023May 3, 2023 by [email protected]

Research News and Market Data on SHWZ

May 3, 2023

OTCQX: SHWZ
NEO: SHWZ

DENVER, May 3, 2023 /CNW/ – Medicine Man Technologies operating as Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), will hold a first quarter earnings webcast on May 10, 2023, at 5:00 pm ET.

Investors and stakeholders may participate in the conference call by dialing 416-764-8650 or by dialing North American toll free 1-888-664-6383 or listen to the webcast from the Company’s website at https://ir.schwazze.com The webcast will be available on the Company’s website and on replay until May 17, 2023, and may be accessed by dialing 416-764-8677 or North American toll free 1-888-390-0541 / 613777 #.

Following their prepared remarks, Management will answer investor questions. Investors may submit questions in advance or during the conference call itself through the weblink: https://app.webinar.net/8JdExl9XLGb This weblink has been posted to the Company’s website and will be archived on the website. All Company SEC filings can also be accessed on the Company website at https://ir.schwazze.com/sec-filings

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

Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

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

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SOURCE Medicine Man Technologies, Inc.

	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

	March 31, 2023		December 31, 2022¹
Assets
Cash and cash equivalents	$	71,975	$	120,229
Prepaid expenses and other		11,751		10,548
Total current assets		83,726		130,777
Other non-current assets		95,362		94,913
Total assets	$	179,088	$	225,690

Liabilities and stockholders’ equity
Total liabilities	$	13,661	$	18,508
Stockholders’ equity		165,427		207,182
Total liabilities and stockholders’ equity	$	179,088	$	225,690

Author: [email protected]

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