Release – Comstock Technology Produces Circular Renewable Fuels

Research News and Market Data on LODE

Technology Unlocks Massive New Feedstock Model to Neutralize America’s Transportation Emissions

VIRGINIA CITY, NEVADA, JANUARY 9, 2022 – Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) today announced the demonstration of breakthrough cellulosic fuels pathways to produce renewable diesel, marine, sustainable aviation fuel (“SAF”) and gasoline from woody biomass at dramatically improved yield, efficiency, and cost in comparison to all known methods, thereby enabling a massive new renewable fuels feedstock capable of neutralizing more than 40% of America’s mobility emissions well before 2050.

Fuel Plantations

Renewable fuels provide a critical opportunity for decarbonization, however, most of the existing U.S. renewable fuel refineries draw from the same limited pool of constrained feedstocks. Comstock technologies resolve that constraint by unlocking abundant woody biomass feedstocks that are not used today and leverage the Earth’s natural carbon cycle and create extraordinary financial incentives for the entire ecosystem to shift away from releasing long cycle fossil carbon to recycling short cycle renewable carbon – to burning “carbon-neutral fuels” in balance with growing more feedstock.

“There is an abundance of wasted and unused forestry and sawmill residues available now to start impacting this dramatic decarbonization and e will also use our technologies to enable an extremely valuable new “soil to oil” ecosystem that uses vast new “fuel plantations” to capture and use carbon dioxide to produce massive amounts of highly scalable and rapidly replenishable renewable fuels feedstocks,” said Corrado De Gasperis, Comstock’s Executive Chairman and Chief Executive Officer. “By unlocking woody biomass, now and in the future, for use in producing drop-in renewable fuels, including for the difficult to decarbonize long haul trucking and aviation sectors, Comstock’s technologies demonstrate that the U.S. can strike and sustain an immensely profitable new net zero balance between the Earth’s living systems and domestic mobility emissions.”

The Department of Energy’s National Renewable Energy Lab has published estimates that the U.S. produces upwards of 100 million tons per year of sawmill and forestry residuals alone. That readily available biomass is sufficient to produce more than 8 billion gallons per year (“BGY”) of drop-in fuels by utilizing Comstock’s technology. Further, just 140 million acres of short rotation trees, such as bamboo, willow and hybrid poplar, would yield enough feedstock biomass to permanently neutralize 40% of America’s mobility emissions with Comstock’s cellulosic fuels processes.

Shovel Ready

Based on current performance data, Comstock projects best-in-class renewable fuel yields exceeding 80 gallons per dry ton (on a gasoline gallon equivalent basis), with lifecycle greenhouse gas emissions reductions well exceeding 80% over petroleum.

By unlocking a massive new sustainable feedstock source, Comstock’s proposed pathway is capable of squarely addressing the goals and objectives of the Biden Administration while creating high-quality jobs, invigorating America’s rural communities, and making a material contribution to achieving the Biden Administration’s objective of delivering net-zero emissions by 2050.

About Comstock Inc.

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complementary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

Forward-Looking Statements

This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future industry market conditions; future explorations or acquisitions; future changes in our exploration activities; future prices and sales of, and demand for, our products; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; and future working capital, costs, revenues, business opportunities, debt levels, cash flows, margins, taxes, earnings and growth. These statements are based on assumptions and assessments made by our management considering their experience and their perception of historical and current trends, current conditions, possible future developments, and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, mercury remediation and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration or mercury remediation, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with mercury remediation, metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; ability to achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology, mercury remediation technology and efficacy, quantum computing and advanced materials development, and development of cellulosic technology in bio-fuels and related carbon-based material production; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise.

Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

  Contact information:  
Comstock Inc.
P.O. Box 1118
Virginia City, NV 89440
www.comstockinc.com
Corrado De Gasperis
Executive Chairman & CEO
Tel (775) 847-4755
[email protected]
Zach Spencer
Director of External Relations
Tel (775) 847-5272 Ext.151
[email protected]

Release – Harte Hanks to Present at Investor Conference

Research News and Market Data on HHS

Monday, January 9, 2023 4:05 PM

CHELMSFORD, MA / ACCESSWIRE / January 9, 2023 / Harte Hanks, Inc. (Nasdaq:HHS), a leading global customer experience company, today announced that management will present at the Sidoti & Company Virtual Micro-Cap Conference on January 18, 2023 at 10:45 a.m. ET. In addition, management will virtually host one-on-one meetings with participating investors on Wednesday, January 18 and Thursday, January 19, 2023.

A webcast of the company’s conference presentation will be available on the Harte Hanks investor relations website at https://investors.hartehanks.com.

Investors interested in a meeting with Harte Hanks management can contact their Sidoti representative or email [email protected].

About Harte Hanks

Harte Hanks (Nasdaq:HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract, and engage their customers.

Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands including Bank of America, GlaxoSmithKline, Unilever, Pfizer, HBOMax, Volvo, Ford, FedEx, Midea, Sony and IBM, among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.

For more information, visit hartehanks.com

As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks.

Investor Relations Contact:

FNK IR
Rob Fink or Tom Baumann
(646) 809-4048 / (646) 349-6641
[email protected]

SOURCE: Harte Hanks, Inc.

Release – Bowlero Corp. Exceeds $1.0 Billion In Trailing TwelveMonth Revenue During Q2 Fy2023

Research News and Market Data on BOWL

01/09/2023

  • Record-breaking revenue performance bolstered by TTM Same Store Sales Growth of approximately 48% year over year1
  • TTM revenue exceeds the $878 million revenue projection from December 2021 go-public transaction by more than $122 million or 14%
  • MoneyBowl, the Company’s proprietary skill-based gamification app, is expected to be active in 27 centers by January 13, 2023, and is already operational in 16 locations
  • Bowlero added 40 bowling centers over the last 18 months, ending Q2 of FY23 with 326 locations

RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL) (“Bowlero” or the “Company”), the world’s largest owner and operator of bowling centers, today provided a preliminary business update covering activity through January 1, 2023, the close of its second quarter of fiscal year 2023.2

Bowling Center Trailing 13-week Revenue Growth Trend (Graphic: Business Wire)

The Company’s revenue exceeded $1.0 billion on a trailing twelve month basis, marking a major milestone in the Company’s history following record revenue generation throughout calendar year 2022. This performance was driven by strong ongoing demand for bowling, the country’s largest participatory sport, across the portfolio exemplified by Bowlero’s same store sales growth of approximately 48% year over year. In particular, the TTM revenue performance was fueled by dramatic year over year growth in events and continued strong performance from walk-in retail and leagues.

The Company’s deployment of Moneybowl™ continues to gain momentum, growing from two locations on November 16, 2022 to an expected 27 locations by January 13, 2023.

Bowling center additions remain a significant factor in driving total revenue growth. Since June 28, 2021, Bowlero has added 40 new centers and has grown its operating center count by 14%. Of the 40 centers added, two locations were new builds and 38 were acquisitions. The pipeline for new locations remains robust.

Thomas Shannon, Founder and Chief Executive Officer, stated, “The last twelve months have been transformational for Bowlero. Exceeding $1.0 billion in TTM revenue is a remarkable milestone for the Company, capping off a year of notable accomplishments. We ended December of 2022 with 326 locations, after continuing our robust unit addition plan. We launched MoneyBowl™, and it should be in pilot at 27 locations, almost ten percent of our footprint, by the end of this week. These accomplishments were almost unimaginable when we operated only six centers back in 2013, and they are a testament to our world-class team and our relentless pursuit of providing world-class experiences across our growing portfolio of nearly 330 centers and maximizing shareholder value.”

Bowling Center Trailing 13-week Revenue Growth Trend 3

[Please see Bowling Center Trailing 13-week Revenue Growth Trend]

About Bowlero Corp.

Bowlero Corp. is the worldwide leader in bowling entertainment. With more than 325 bowling centers across North America, Bowlero Corp. serves nearly 30 million guests each year through a family of brands that includes Bowlero and AMF. Bowlero Corp. is also home to the Professional Bowlers Association, which boasts thousands of members and millions of fans across the globe. For more information on Bowlero Corp., please visit BowleroCorp.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 that involve risk, assumptions and uncertainties, such as statements of our plans, objectives, expectations, intentions and forecasts. These forward-looking statements are generally identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “confident,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. These forward-looking statements reflect our views with respect to future events as of the date of this press release and are based on our management’s current expectations, estimates, forecasts, projections, assumptions, beliefs and information. Although management believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will prove to have been correct. All such forward-looking statements are subject to risks and uncertainties, many of which are outside of our control, and could cause future events or results to be materially different from those stated or implied in this press release. It is not possible to predict or identify all such risks. These risks include, but are not limited to: the impact of COVID-19 pandemic and any future outbreaks of contagious diseases on our business; our ability to design and execute our business strategy; changes in consumer preferences and buying patterns; our ability to compete in our markets; the occurrence of unfavorable publicity; risks associated with long-term non-cancellable leases for our centers; our ability to retain key managers; risks associated with our substantial indebtedness and limitations on future sources of liquidity; our ability to carry out our expansion plans; our continued ability to produce content, build infrastructure and market Professional Bowlers Association (“PBA”) events; our ability to successfully defend litigation brought against us; our ability to adequately obtain, maintain, protect and enforce our intellectual property and proprietary rights and claims of intellectual property and proprietary right infringement, misappropriation or other violation by competitors and third parties; failure to hire and retain qualified employees and personnel; the cost and availability of commodities and other products we need to operate our business; cybersecurity breaches, cyber-attacks and other interruptions to our and our third-party service providers’ technological and physical infrastructures; catastrophic events, including war, terrorism and other conflicts; public health issues or natural catastrophes and accidents; changes in the regulatory atmosphere and related private sector initiatives; fluctuations in our operating results; economic conditions, including the impact of increasing interest rates, inflation and recession; and other risks, uncertainties and factors described under the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) by the Company on September 15, 2022, as well as other filings that the Company will make, or has made, with the SEC, such as Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this press release and in other filings. We expressly disclaim any obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by applicable law.

1Same-store sales are measured by comparing revenues for centers open for the entire duration of both the current and comparable measurement periods.
2Our independent registered public accounting firm has not completed its review of our results for our second quarter ended on January 1, 2023. The revenue amounts for this quarter are preliminary estimates of the results of operations that we expect to report for our second quarter ended on January 1, 2023. Our actual results may differ from these estimates due to the completion of our financial closing procedures, final adjustments and other developments that may arise between now and the time the financial results for our second quarter are finalized.
3Revenue growth is calculated as the growth in Bowling Center Revenue compared to the comparable week during the pre-pandemic 52-week period beginning March 2019 and ending February 2020. Total Bowling Center Revenue (i) excludes media-related revenue and closed bowling centers from both current period and pre-pandemic and prior year periods and (ii) includes new bowling centers that have opened since March 2020. For weeks ending between September 26, 2021 and December 26, 2021, the percentages above are calculated by comparing each week to the comparable week in 2019. For weeks ending between January 2, 2022 and February 27, 2022, the percentages above are calculated by comparing each week to the comparable week in 2020. For weeks ending between March 6, 2022 and January 1, 2023, the percentages above are calculated by comparing each week to the comparable week in 2019. Total Bowling Center Revenue for each date is the 13-week rolling average of weekly Total Bowling Center Revenue. We use the 13-week rolling average because the revenue performance in individual weeks can be positively or negatively impacted by timing shift of holiday/sporting events, holidays moving to weekends, and extreme weather events. Data for all weeks following the close of the quarter ended on October 2, 2022 are preliminary and have not been audited or reviewed and are forward-looking statements based solely on information available to us as of the date of this announcement.

For Media:
Bowlero Corp. Public Relations
[email protected]

For Investors:
Bowlero Corp. Public Relations
[email protected]

Ashley DeSimone
[email protected]

Source: Bowlero Corp.

Release – Maple Gold Drills 10.3 g/t Gold over 7.8 Metres, Including 41.1 g/t Gold over 1 Metre, in the North Mine Horizon at Eagle

Research News and Market Data on MGMLF

Vancouver, British Columbia–(Newsfile Corp. – January 9, 2023) – Maple Gold Mines Ltd. (TSXV: MGM) (OTCQB: MGMLF) (FSE: M3G) (“Maple Gold” or the “Company“) is pleased to report additional assay results from the Company’s 2022 drilling at its 100%-controlled Eagle Mine Property (“Eagle”) located in Québec, Canada. The new results represent complete assays from five (5) follow-up holes for which partial results were previously reported (see news from December 13, 2022), targeting northwest extensions of the main mine horizon and along multiple sub-parallel gold horizons (see Figures 1 and 2). The Company’s latest drilling in the northern splay of the main mine horizon (the “North Mine Horizon”) has returned the best intercept to-date from its 2022 program at Eagle.

Highlights:

  • Drill hole EM-22-015 intersected 10.3 g/t gold (“Au”) over 7.8 metres (“m”), including 41.1 g/t Au over 1.0 m in the North Mine Horizon.
  • Further up-hole, EM-22-015 intersected 4.3 g/t Au over 3.9 m, including 6.6 g/t Au over 2.0 m, demonstrating the potential for the North Mine Horizon to be wider than what was previously interpreted (see Figure 2).
  • The EM-22-015 intercepts are located down-plunge from historical high-grade, near-surface drill results from a geologically similar hole (E-19: 19.6 g/t Au over 7.9 m, as well as 17.5 g/t Au over 5.6 m further up-hole) in an area with limited drilling that remains open further down-plunge (see Figure 3).
  • EM-22-015 has now returned seven (7) separate intercepts over a 120 m interval starting from 142.5 m downhole.
  • Assays are still pending for roughly 20% of the Company’s 2022 drilling at Eagle.

“Drill results continue to support the Company’s view that multiple sub-parallel gold horizons exist beyond what was historically mined at Eagle and have expanded our target areas along a broader mineralized corridor over a stratigraphic thickness that now exceeds 100 metres in width,” stated Matthew Hornor, CEO of Maple Gold. “There is an apparent concentration of >10 g/t gold starting near surface and extending down-plunge to the EM-22-015 intercepts along the North Mine Horizon in an area with limited drilling that remains open further down-plunge. This represents just one of several compelling follow-up targets that we are excited to pursue in 2023.”

Interpretation and Summary of Results

Key assay results reported herein are from holes drilled at different orientations from the site of hole EM-22-005 (see news from June 20, 2022); three (3) starting from the same drill collar (EM-22-013, EM-22-015, EM-22-016) and one (1) wedge drill hole (EM-22-005W). The new results from EM-22-015 support the Company’s model of multiple sub-parallel gold horizons, some of which are particularly high-grade (>10 g/t), extending from the southern splay of the main mine horizon (the “South Mine Horizon”) to beyond the North Mine Horizon over a mineralized corridor that now exceeds 100 m in width. These two horizons merge into a single main mine horizon in the central part of the Eagle property (see Figure 1).

Figure 1: Plan view showing all 2022 drill holes (28) at Eagle with lines of section for Figures 2 and 3.
 
To view an enhanced version of Figure 1, please visit:
https://images.newsfilecorp.com/files/3077/150640_45b1d27564c2d9fc_001full.jpg

Gold mineralization at Eagle is not only limited to the known main mine horizon, hosted in mixed epiclastic and pyroclastic rocks of the northern part of the Joutel-Raymond volcanic complex, but also extends into a sill-like microgabbro occurring close to the Harricana Fault, and sporadically into the Harricana sediments further to the north.

Figure 2: NW-looking cross section (85 m total width) highlighting new assay results (gold boxes) and previously reported/historical intercepts (white boxes) along well-defined sub-parallel horizons.
 
To view an enhanced version of Figure 2, please visit:
https://images.newsfilecorp.com/files/3077/150640_45b1d27564c2d9fc_002full.jpg

 

Figure 3: NE-looking long section (55 m total width) highlighting the location of the EM-22-015 intercept (10.3 g/t Au over 7.8 m) relative to pre-existing grade contouring in the North Mine Horizon. Note the open area extending down-plunge from hole E-19 (19.6 g/t Au over 7.9m).
 
To view an enhanced version of Figure 3, please visit:
https://images.newsfilecorp.com/files/3077/150640_45b1d27564c2d9fc_003full.jpg


The EM-22-015 intercepts are located approximately 60 m down-plunge from historical hole E-19. Additional historical drill holes intersected >5g/t Au roughly 250 m further down-plunge, highlighting the grade and volume potential of this new zone that will be tested via follow-up drilling in 2023.

In contrast with the South Mine Horizon, which is hosted in a mixed package of fine-grained crystal tuffs and laminated sediments with the latter hosting most of the gold-bearing semi-massive sulfide mineralization cut by irregular ankerite-(quartz) veinlets, the North Mine Horizon is associated with coarser lapilli-tuffs that appear to have been quite permeable and allowed deposition of abundant matrix sulfide (see Plate 1) adjacent to and overlapping with the microgabbro further downhole. The distribution of these coarse tuffs adjacent to the microgabbro represent a favorable target that has relatively limited drilling to the northwest as well as down-dip and down-plunge (see Figures 2 and 3).


 

Plate 1: EM-22-015 intercept at 230.8 m downhole in lapilli-tuff host. Sulfide patches in between lapilli are semi-massive to massive. NQ core, 47.6mm diameter.
 
To view an enhanced version of Plate 1, please visit:
https://images.newsfilecorp.com/files/3077/150640_45b1d27564c2d9fc_004full.jpg

Intercepts >2 g/t Au have now been obtained at Eagle at downhole depths ranging from 109 to 1,234 m, which is indicative of the significant depth continuity of the system. Multi-element geochemistry, a first for the Eagle project, indicates that Au is associated with elevated silver (“Ag”) and that several additional elements can be used for targeting purposes as they provide for a significantly broader footprint than Au and Ag alone.

The Company completed a total of 28 drill holes corresponding to ~13,823 m at Eagle during 2022. Approximately 20% of the assays for the entire program are still pending. Additional assay results will be released on a periodic basis over the coming months once they are received and interpreted.

Outlook for Further Exploration at Eagle-Telbel

The Company’s next steps will include a comprehensive review of all available data at Eagle, including incorporating results from the 2022 program into its 3D geological model, along with definition of priority targets for follow-up drilling in H1 2023. The Company also believes that continued drilling success at Eagle will relate positively to ongoing exploration on its joint venture ground at Telbel and along the entire Joutel Deformation Zone.

Table 1: Complete assay results for EM-22-015 and nearby drill holes at Eagle
(note: bolded Drill Hole IDs correspond to new assay results).

Drill Hole ID UTMEUTMNAzimuthPlungeLength (m)FromToIntervalAu g/t
EM-22-013690758548604363.8-69.8327257.0267.410.42.3
including     257.0260.23.25.0
EM-22-013     273.0273.70.71.8
EM-22-013     298.0299.01.01.5
EM-22-014690565548633464.5-67.9621160.0160.70.71.8
EM-22-014     231.0231.70.74.6
EM-22-014     272.0273.01.01.3
EM-22-015690758548604345-50.1411142.5148.66.11.6
EM-22-015     164.9165.50.74.8
EM-22-015     217.1221.03.94.3
including     218.5220.52.06.6
EM-22-015     228.0235.87.810.3
including     228.5232.84.315.9
including     230.0231.01.041.1
EM-22-015     246.7248.41.74.3
including     247.5248.40.97.1
EM-22-015     252.2255.02.81.8
EM-22-015     260.0262.62.61.1
EM-22-016690758548604345-62.6297182.6183.20.61.7
EM-22-016     193.0200.37.33.1
including     196.0199.63.64.0
EM-22-016     202.0206.24.21.7
including     204.3206.21.92.7
EM-22-005W69079554861362.2-65.5363364.3365.81.51.3
EM-22-005W     624.0625.01.01.2

All intervals are downhole lengths. True widths are estimated to be between 35% (for steeper holes) to 80% (for shallower angle holes) of downhole lengths. Assays are uncut, but overlimits (>10 g/t Au initial assay) were reassayed using Fire Assay with Gravimetric finish, and subsequently, screen metallics. The latter results are deemed more accurate and are reported here.

Qualified Person

The scientific and technical data contained in this press release was reviewed and prepared under the supervision of Fred Speidel, M. Sc., P. Geo., Vice-President Exploration of Maple Gold. Mr. Speidel is a Qualified Person under National Instrument 43-101 Standards of Disclosure for Mineral Projects. Mr. Speidel has verified the data related to the exploration information disclosed in this press release through his direct participation in the work.

Quality Assurance (QA) and Quality Control (QC)

The Company implements strict Quality Assurance (“QA”) and Quality Control (“QC”) protocols at Eagle covering the planning and placing of drill holes in the field; drilling and retrieving the NQ-sized drill core; drill hole surveying; core transport; core logging by qualified personnel; sampling and bagging of core for analysis; transport of core from site to the Val d’Or, Québec AGAT laboratory; sample preparation for assaying; and analysis, recording and final statistical vetting of results. Check assays for gold are being done on a sample subset at ALS’ laboratory in Val d’Or. For a complete description of protocols, please visit the Company’s QA/QC webpage at www.maplegoldmines.com.

About Maple Gold

Maple Gold Mines Ltd. is a Canadian advanced exploration company in a 50/50 joint venture with Agnico Eagle Mines Limited to jointly advance the district-scale Douay and Joutel gold projects located in Québec’s prolific Abitibi Greenstone Gold Belt. The projects benefit from exceptional infrastructure access and boast ~400 km2 of highly prospective ground including an established gold resource at Douay (SLR 2022) that holds significant expansion potential as well as the past-producing Eagle, Telbel and Eagle West mines at Joutel. In addition, the Company holds an exclusive option to acquire 100% of the Eagle Mine Property.

The district-scale property package also hosts a significant number of regional exploration targets along a 55 km strike length of the Casa Berardi Deformation Zone that have yet to be tested through drilling, making the project ripe for new gold and polymetallic discoveries. The Company is well capitalized and is currently focused on carrying out exploration and drill programs to grow resources and make new discoveries to establish an exciting new gold district in the heart of the Abitibi. For more information, please visit www.maplegoldmines.com.

ON BEHALF OF MAPLE GOLD MINES LTD.

“Matthew Hornor”

B. Matthew Hornor, President & CEO

For Further Information Please Contact:

Mr. Joness Lang
Executive Vice-President
Cell: 778.686.6836
Email: [email protected]

Mr. Jeff Uppal
Manager, Investor Relations
Cell: 778.977.4724
Email: [email protected]

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS PRESS RELEASE.

Forward-Looking Statements:

This press release contains “forward-looking information” and “forward-looking statements” (collectively referred to as “forward-looking statements”) within the meaning of applicable Canadian securities legislation in Canada, including statements about exploration work and results from current and future work programs. Forward-looking statements are based on assumptions, uncertainties and management’s best estimate of future events. Actual events or results could differ materially from the Company’s expectations and projections. Investors are cautioned that forward-looking statements involve risks and uncertainties. Accordingly, readers should not place undue reliance on forward-looking statements. For a more detailed discussion of such risks and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements, refer to Maple Gold Mines Ltd.’s filings with Canadian securities regulators available on www.sedar.com or the Company’s website at www.maplegoldmines.comThe Company does not intend, and expressly disclaims any intention or obligation to, update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/150640

Release – Ocugen Announces Positive Top-Line Data For Covid-19 Vaccine Candidate Covaxin™ (Bbv152) In Phase 2/3 Immuno-Bridging And Broadening Study: Both Co-Primary Endpoints Met

Research News and Market Data on OCGN

January 9, 2023

  • Study met both co-primary endpoints with robust immune responses
  • COVAXIN was found to be well-tolerated in vaccine-naïve individuals and in individuals previously vaccinated with mRNA vaccines in the United States (U.S.), with no vaccine-related serious adverse events, thrombotic events, or cases of myocarditis or pericarditis
  • These data add to the body of evidence that COVAXIN™, an adjuvated whole SARS-CoV-2 virus inactivated vaccine, has been demonstrated to be well-tolerated and effective against COVID-19 disease

MALVERN, Pa., Jan. 09, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen) (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced positive results from the Phase 2/3, observer-blind, immuno-bridging and broadening study of its COVID-19 vaccine candidate, COVAXIN™ (BBV152; Clinicaltrials.gov, NCT05258669), a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades. COVAXIN™, an inactivated virus vaccine adjuvanted with TLR7/8 agonist, has been demonstrated in clinical trials to generate a broader immune response against the whole virus covering important antigens such as S-protein, RBD, and N-protein; whereas currently approved vaccines in the U.S. target only S-protein antigen. Additionally, in contrast to other inactivated vaccines, clinical trials have demonstrated that TLR7/8 agonist adjuvant in COVAXIN™ generates a Th1-biased immune response that induces robust long-term memory B- and T-cell responses.

“The successful completion of this study represents an important milestone to the ongoing management of COVID-19,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “Given that a portion of the public remains hesitant to receive mRNA vaccines, this investigational COVID-19 vaccine candidate, which relies on a well-established approach to vaccine development and manufacturing, may provide an important additional vaccine option.”

This study enrolled 419 U.S. adult participants that were randomized 1:1 to receive two doses of COVAXIN™ or placebo, 28 days apart. Blinded safety results and preliminary unblinded immunogenicity results are available through Day 56, one month following the second vaccination. Immunogenicity results from COVAXIN™-vaccinated participants in the U.S. were compared with results in COVAXIN™-vaccinated participants in the Bharat Biotech International Limited (Bharat Biotech)-sponsored Phase 3 study in India (Clinicaltrials.gov NCT04641481). Approximately 24% of tested participants in the U.S. were vaccine-naïve while all participants in the Bharat Biotech Phase 3 study were vaccine-naïve. Immune responses were adjusted for differences between the U.S. and Indian cohorts in baseline neutralizing antibody, body mass index, gender, and age. Both co-primary immunogenicity endpoints were met, with the 95% confidence interval (CI) for the propensity score-adjusted geometric mean titer ratio (U.S./India) well above the non-inferiority limit of 0.667 and the 95% CI for the propensity score-adjusted difference in seroconversion rates well above the non-inferiority limit of -10%.

Blinded safety data are also available for one month following vaccination. There were no deaths, related potential immune mediated medical conditions (PIMMCs), or related adverse events of special interest (AESIs). There were also no cases of myocarditis, pericarditis, thrombotic events, or Guillain-Barré syndrome. Thirty medically attended adverse events in 18 subjects and two serious adverse events (SAE) in one subject were reported, and all were considered unrelated to vaccination.

“These positive data represent an important step in the management of the ever-evolving COVID-19 pandemic,” said Dr. Eric Feigl-Ding, epidemiologist and health economist, Chief of COVID Task Force at the New England Complex Systems Institute, Co-Founder of the World Health Network, and the Chief Health Economist for Microclinic International. “The need for different vaccine approaches to COVID-19 has become critically apparent with the continued emergence of variants to the SARS-CoV-2 virus.”

The top-line data from the immuno-bridging and broadening study will be critical to support Ocugen’s future plans for the development of COVAXIN™ in the U.S.

About COVAXIN™ (BBV152)
COVAXIN™ is an investigational vaccine candidate product in North America. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

COVAXIN™ is currently approved for adults in India and authorized under emergency use in 25 countries, with more than 350 million doses administered to adults outside the United States to date. COVAXIN™ is listed by the World Health Organization (WHO) as authorized for emergency use. Applications for emergency use authorization are pending in more than 60 other countries. Additionally, as many as 85 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN™.

About the OCU-002 Study
OCU-002 is a randomized, observer-blind, placebo-controlled, immune-bridging, and broadening study conducted in 8 sites in the United States (Clinicaltrials.gov, NCT05258669). 419 U.S. participants were randomized to received two doses of vaccine 1:1 to COVAXIN™ or placebo, 28 days apart. Blinded safety results and unblinded immunogenicity results are available through Day 56, one month following the second vaccination.

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 patients’ 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.

About Bharat Biotech
Bharat Biotech International Limited has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 19 vaccines, four bio-therapeutics, registrations in more than 125 countries, and the World Health Organization (WHO) Prequalification. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, BBIL has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. Having delivered more than 5 billion doses of vaccines worldwide, BBIL continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis (JENVAC®), Rabies, Chikungunya, Zika, Cholera, and the world’s first tetanus toxoid conjugated vaccine for Typhoid. BBIL’s commitment to global social innovation programs and the public-private partnership resulted in introducing path-breaking WHO pre-qualified vaccines such as BIOPOLIO®, ROTAVAC®, ROTAVAC® 5D, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. Novel vaccines against malaria and tuberculosis are under development through global partnerships. The acquisition of Chiron Behring Vaccines has positioned BBIL as the world’s largest rabies vaccine manufacturer with Chirorab® and Indirab®. Bharat Biotech’s COVAXIN®, India’s indigenous COVID-19 vaccine was developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).

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.

Ocugen Contact: 
Tiffany Hamilton
Head of Communications
[email protected]

Release – Alvopetro Announces Record December 2022 Sales Volumes and an Operational Update

Research News and Market Data on ALVOF

Jan 06, 2023

CALGARY, AB, Jan. 6, 2023 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces record sales volumes in December 2022 and an operational update.

December 2022 sales volumes

December sales volumes averaged 2,785 boepd, including natural gas sales of 15.9 MMcfpd and associated natural gas liquids sales from condensate of 125 bopd, and 15 bopd of oil sales, based on field estimates, a 4% increase from our November 2022 average daily volumes.  Our sales volumes averaged 2,724 boepd in the fourth quarter of 2022, an increase of 3% from the third quarter of 2022.

Operational Update

We have completed testing our 182-C2 well on our 100% owned and operated Block 182. We completed drilling the 182-C2 well in October to a total measured depth (“MD”) of 3,185 metres. As previously announced, based on open-hole wireline logs, the well encountered a 223.7-metre-thick section with 121.3 metres of sand estimated above 6% porosity in the sand-dominated interval between 2,704.1 and 2,927.8 metres total vertical depth in the Sergi Formation. The well also encountered 10.9 metres of potential net hydrocarbon pay in the Agua Grande Formation, with an average porosity of 8.9% and average water saturation of 25.1%, using a 6% porosity cut-off, 50% Vshale cut-off and 50% water saturation cut-off. During testing operations of the Sergi and Agua Grande Formations we recovered non-commercial amounts of oil and natural gas. These results indicate lower than anticipated permeability and we are evaluating alternatives to remove any near well bore formation damage and reservoir stimulations to enhance permeability in the Agua Grande and Sergi Formations in this well, and the Sergi Formation in our 183-B1 well.

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/AlvopetroEnergy     Instagram – https://www.instagram.com/alvopetro/     LinkedIn – https://www.linkedin.com/company/alvopetro-energy-ltd     YouTube –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                        =              barrelsboepd                    =              barrels of oil equivalent (“boe”) per daybopd                      =              barrels of oil and/or natural gas liquids (condensate) per dayMMcf                     =              million cubic feetMMcfpd                 =              million cubic feet per day

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.

Testing and Well Results. Data obtained from the 182-C2 well identified in this press release, including hydrocarbon shows, open-hole logging, net pay and porosities and initial testing data, should be considered to be preliminary until detailed pressure transient and other analysis and interpretation has been completed. Hydrocarbon shows can be seen during the drilling of a well in numerous circumstances and do not necessarily indicate a commercial discovery or the presence of commercial hydrocarbons in a well. There is no representation by Alvopetro that the data relating to the 182-C2 well contained in this press release is necessarily indicative of long-term performance or ultimate recovery. The reader is cautioned not to unduly rely on such data as such data may not be indicative of future performance of the well or of expected production or operational results for Alvopetro in the future.

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 potential hydrocarbon pay in the 182-C2 well, exploration and development prospects of Alvopetro and the expected timing of certain of Alvopetro’s testing and operational activities. The forward–looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to expectations and assumptions concerning testing results of the 183-B1 well and the 182-C2 well, equipment availability, the timing of regulatory licenses and approvals, the success of future drilling, completion, testing, recompletion and development activities, the outlook for commodity markets and ability to access capital markets, the impact of the COVID-19 pandemic, the performance of producing wells and reservoirs, well development and operating performance, foreign exchange rates, general economic and business conditions, weather and access to drilling locations, the availability and cost of labour and services, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, 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 – CoreCivic to Redeem 4.625% Senior Notes Due 2023

Research, News, and Market Data on CXW

December 22, 2022

BRENTWOOD, Tenn., Dec. 22, 2022 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (CoreCivic or the Company) announced today that it is delivering an irrevocable notice to the holders of all of the Company’s previously issued $350,000,000 original aggregate principal amount of 4.625% Senior Notes due 2023 (2023 Notes) that the Company has elected to redeem in full the 2023 Notes that remain outstanding on February 1, 2023 (Redemption Date). The 2023 Notes were otherwise scheduled to mature on May 1, 2023. The 2023 Notes will be redeemed at a redemption price equal to 100% of the principal amount of the then outstanding 2023 Notes, plus accrued and unpaid interest on such 2023 Notes to, but not including, the Redemption Date (Redemption Price). As of December 21, 2022, the principal amount of the outstanding 2023 Notes was $153.9 million. The Company intends to use a combination of cash on hand and available capacity under its revolving credit facility to fund the Redemption Price.

Redemption of the 2023 Notes is consistent with the Company’s multi-year debt reduction strategy. Following the redemption, the Company will have no debt maturing until April 2026.

This press release shall not constitute a notice of redemption of the 2023 Notes.

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. CoreCivic provides 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. CoreCivic is the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believes it is the largest private owner of real estate used by government agencies in the United States. CoreCivic has been a flexible and dependable partner for government for nearly 40 years. CoreCivic’s 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 forward-looking statements (as defined within the meaning of the Private Securities Litigation Reform Act of 1995), including statements regarding CoreCivic’s redemption of the 2023 Notes and its funding of the Redemption Price. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. Important factors that could cause actual results to differ are described in the filings made from time to time by CoreCivic with the U.S. Securities and Exchange Commission (SEC) and include the risk factors described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, the Company’s Quarterly Reports on Form 10-Q and other reports filed with the SEC.

CoreCivic takes 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.

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

Release – Direct Digital Holdings to Participate in the 25th Annual ICR Conference

Research, News, and Market Data on DRCT

December 21, 2022 9:00am EST

HOUSTON, Dec. 21, 2022 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced that the Company will participate in the 25th Annual ICR Conference from January 9-11, 2023 in Orlando, Florida.

Mark Walker, Chairman & Chief Executive Officer, Keith Smith, President, and Susan Echard, Chief Financial Officer, will participate in the conference. Management will be hosted in a fireside chat on Tuesday, January 10, 2023 at 10:00 AM ET and will also be available for meetings. A replay of the fireside chat will be available the following day on the Direct Digital Holdings IR Website at https://ir.directdigitalholdings.com/.

About Direct Digital Holdings

Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage approximately 90,000 clients monthly, generating over 100 billion impressions per month across display, CTV, in-app and other media channels. Direct Digital Holdings is the ninth black-owned company to go public in the U.S and was named a top minority-owned business by The Houston Business Journal.

View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-to-participate-in-the-25th-annual-icr-conference-301707791.html

SOURCE Direct Digital Holdings

Released December 21, 2022

Release – Great Lakes Provides an Update to Q4 2022

Research, News, and Market Data on GLDD

Dec 20, 2022

HOUSTON, Dec. 20, 2022 (GLOBE NEWSWIRE) — Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) (NASDAQ: GLDD), the largest provider of dredging services in the United States, announced an update on its fourth quarter 2022 operations.

Revenues and gross profit margins for fourth quarter 2022 are expected to be lower than previously anticipated. These results were impacted by the earlier than expected retirement of the Terrapin Island hopper dredge, significant weather delays on several projects in the northeast and some project production issues. Additionally, unexpected drydocking scope increases resulted in additional costs and delays for the hopper dredges Ellis Island and Padre Island. The Padre Island is now out of drydock and in operation and the Ellis Island is out of drydock and  expected to be in operation before year end. 

General and administrative expense and net interest expense are expected to remain relatively flat from the prior quarter.

Lasse Petterson, President and Chief Executive Officer at Great Lakes commented, “This has been a challenging year driven by an extremely slow bid market in the first half of 2022, rampant inflation, supply chain delays and more than the usual number of differing site conditions on projects. We are proactively taking steps to minimize the impact of these external factors as we are rationalizing older assets like the previously announced retirement of the Terrapin Island, cold stacking several of our oldest and least productive dredges and aggressively reducing other costs.

Looking forward to 2023, we expect bidding activity to be more in line with previous years as several large capital projects that were expected to bid in 2022 are now expected to bid in the first half of the year and our LNG prospects are moving toward final investment decisions. We are on track with our fleet modernization program and our newbuild hopper dredge, the Galveston Island, is on schedule to be operational in the second quarter of 2023. As we see the bid market start to recover in 2023, we can quickly reactivate the cold stacked vessels to take advantage of the improving market. We believe we are proactively taking the right steps adjusting to the current market conditions and expect to see their positive effects as we go into next year.”

The Company
Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 132-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking” statements, including, but not limited to, the statements regarding revenue and gross margin projections, as defined in Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), the Private Securities Litigation Reform Act of 1995 (the “PSLRA”) or in releases made by the Securities and Exchange Commission (the “SEC”), all as may be amended from time to time. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of Great Lakes and its subsidiaries, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements that are not historical fact are forward-looking statements. Forward-looking statements can be identified by, among other things, the use of forward-looking language, such as the words “plan,” “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project,” “may,” “would,” “could,” “should,” “seeks,” “are optimistic,” or “scheduled to,” or other similar words, or the negative of these terms or other variations of these terms or comparable language, or by discussion of strategy or intentions. These cautionary statements are being made pursuant to the Exchange Act and the PSLRA with the intention of obtaining the benefits of the “safe harbor” provisions of such laws. Great Lakes cautions investors that any forward-looking statements made by Great Lakes are not guarantees or indicative of future performance. Important assumptions and other important factors that could cause actual results to differ materially from those forward-looking statements with respect to Great Lakes include, but are not limited to: the impact of the COVID-19 pandemic and related responsive measures, including productivity impacts and increased expenditures; our ability to obtain and retain federal government dredging and other contracts, which is impacted by the amount of government funding for dredging and other projects and the degree to which government funding is directed to the Corps and certain other customers, which in turn could be impacted by extended federal government shutdowns or declarations of additional national emergencies; our ability to qualify as an eligible bidder under government contract criteria and to compete successfully against other qualified bidders in order to obtain government dredging and other contracts; cost over-runs, operating cost inflation and potential claims for liquidated damages, particularly with respect to our fixed cost contracts; the timing of our performance on contracts and new contracts being awarded to us; significant liabilities that could be imposed were we to fail to comply with government contracting regulations; increasing costs to operate and maintain aging vessels and comply with applicable regulations or standards; increasing costs of fleet improvements to remain competitive; equipment or mechanical failures; impacts to our facilities and suppliers from pandemics, epidemics or outbreaks of infectious disease affecting our markets; market or supply chain disruptions as a result of war or insurrection; impacts to our supply chain for procurement of new vessel build materials: our international dredging operations; instability and declining relationships amongst certain governments in the Middle East and the impact this may have on infrastructure investment, asset value of such operations, and local licensing, permitting and royalty issues; capital and operational costs due to environmental regulations or extreme weather events; market and regulatory responses to climate change; contract penalties for any projects that are completed late; force majeure events, including natural disasters, pandemics and terrorists’ actions; changes in the amount of our estimated backlog; significant negative changes to large, single customer contracts; our ability to obtain potential financing for the construction of new vessels, including our new offshore wind vessel; potential inability to secure contracts to utilize new offshore wind vessel; unforeseen delays and cost overruns related to the construction of new vessels, including potential mechanical and engineering issues and unforeseen changes in environmental regulations; any failure to comply with Section 27 of the Jones Act provisions on coastwise trade, or if those provisions were modified or repealed; fluctuations in fuel prices, particularly given our dependence on petroleum-based products; impacts of nationwide inflation on procurement of new build materials; our ability to obtain bonding or letters of credit and risks associated with draws by the surety on outstanding bonds or calls by the beneficiary on outstanding letters of credit; acquisition integration and consolidation, including transaction expenses, unexpected liabilities and operational challenges and risks; divestitures and discontinued operations, including retained liabilities from businesses that we sell or discontinue; potential penalties and reputational damage as a result of legal and regulatory proceedings, including a pending criminal proceeding in Louisiana; any liabilities imposed on us for the obligations of joint ventures, partners and subcontractors; increased costs of certain material used in our operations due to newly imposed tariffs; unionized labor force work stoppages; any liabilities for job-related claims under federal law, which does not provide for the liability limitations typically present under state law; operational hazards, including any liabilities or losses relating to personal or property damage resulting from our operations; our ability to identify and contract with qualified MBE or DBE contractors to perform as subcontractors; our substantial amount of indebtedness, which makes us more vulnerable to adverse economic and competitive conditions; restrictions on the operation of our business imposed by financing covenants; impacts of adverse capital and credit market conditions on our ability to meet liquidity needs and access capital; our ability to maintain or expand our credit capacity; limitations on our hedging strategy imposed by statutory and regulatory requirements for derivative transactions; foreign exchange risks, in particular, as it relates to the new offshore wind vessel build; losses attributable to our investments in privately financed projects; restrictions on foreign ownership of our common stock; restrictions imposed by Delaware law and our charter on takeover transactions that stockholders may consider to be favorable; restrictions on our ability to declare dividends imposed by our financing agreements and Delaware law; significant fluctuations in the market price of our common stock, which may make it difficult for holders to resell our common stock when they want or at prices that they find attractive; changes in previous recorded net revenue and profit as a result of the significant estimates made in connection with our methods of accounting for recognized revenue; maintaining an adequate level of insurance coverage; our ability to find, attract and retain key personnel and skilled labor; disruptions, failures, data corruptions, cyber-based attacks or security breaches of the information technology systems on which we rely to conduct our business; and impairments of our goodwill or other intangible assets. For additional information on these and other risks and uncertainties, please see Item 1A. “Risk Factors” of Great Lakes’ Annual Report on Form 10-K for the year ended December 31, 2021.1

Although Great Lakes believes that its plans, intentions and expectations reflected in or suggested by such forward looking statements are reasonable, actual results could differ materially from a projection or assumption in any forward-looking statements. Great Lakes’ future financial condition and results of operations, as well as any forward-looking statements, are subject to change and inherent risks and uncertainties. The forward-looking statements contained in this press release are made only as of the date hereof and Great Lakes does not have or undertake any obligation to update or revise any forward-looking statements whether as a result of new information, subsequent events or otherwise, unless otherwise required by law.

For further information contact:
Tina Baginskis
Director, Investor Relations
630-574-3024

Release – Onconova Therapeutics Appoints Drs. Peter Atadja and Trafford Clarke to its Board of Directors

Research, News, and Market Data on ONTX

NEWTOWN, Pa., Dec. 19, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced the appointments of Peter Atadja, Ph.D., and Trafford Clarke, Ph.D., as independent members of the Company’s Board of Directors.

“It is my pleasure to welcome Peter and Trafford to our Board,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “Their track record of successfully building and leading teams tasked with the discovery, development, and delivery of novel therapies is impressive. I look forward to benefiting from their strategic counsel and expect their decades of experience in leadership roles at premier pharmaceutical companies will be invaluable as we work to efficiently advance our pipeline and execute on our corporate objectives.”

Dr. Atadja commented, “Joining Onconova’s Board is an honor and truly exciting opportunity. The Company’s lead asset, narazaciclib, has the potential to address unmet needs in a variety of cancers and overcome the limitations of currently approved CDK 4/6 inhibitors. The upcoming trial of narazaciclib plus letrozole in endometrial cancer is both well designed and supported by a robust clinical dataset providing proof-of-concept for narazaciclib’s differentiated mechanism of action in this indication. I am eager to begin working with my fellow Board members and the Company’s management team to advance its lead program and help guide rigosertib through investigator-sponsored trials.”

Dr. Clarke added, “I believe Onconova is well-positioned for sustained growth, as the Company is advancing differentiated, clinical-stage assets with a strong financial foundation and a talented team that has brought some of the most impactful oncology products to the clinic. I look forward to lending my insights to company management as they progress towards their goal of providing cancer patients with novel, best-in-class therapies that improve survival and quality of life.”

Dr. Atadja joins Onconova’s Board with over two decades of experience in the pharmaceutical industry. He is currently the Chief Scientific Officer (CSO) of CommBio Therapeutics, a biotechnology company dedicated to developing a new class of medicine for a spectrum of diseases by modulating intestinal functions. Prior to joining CommBio, Dr. Atadja co-founded and served as the CSO of K36 Therapeutics, a biotechnology company that aims to translate epigenetic modulation of oncogenic pathways into first-in-class small molecule therapeutics. From 1997 – 2021, Dr. Atadja held roles of increasing responsibility at Novartis Pharmaceuticals, most recently serving as the company’s Executive Director & Head, Drug Discovery & Translational Research. While at Novartis, he led the discovery, development, and registration of the first FDA and EMA approved HDAC inhibitor (FARYDAK®) and launched three major research programs (oncology, liver diseases, regenerative medicine), resulting in the addition of 20 novel targets, eight first-in-class candidates, and two clinical candidates to the company’s global pipeline. In 2008, Dr. Atadja was the Novartis VIVA Discovery Award Winner endowed with “Novartis Leading Scientist” title. He has a Ph.D. in molecular oncology from University of Calgary, a Master of Science in pharmaceutical and medicinal chemistry from Hebrew University, and a Bachelor of Pharmacy in medicinal chemistry from Kumasi University of Science and Technology, in Kumasi, Ghana.

Dr. Clarke is a pharmaceutical industry veteran who has dedicated his career to the discovery, development, and launch of new medicines. He spent 31 years working in roles of increasing responsibility at Eli Lilly and Company before retiring in 2017, most recently serving as a Managing Director and UK Research and Development Site Head from 2013 to 2017. In this role, Dr. Clarke led a team of approximately 700 people and oversaw site productivity, infrastructure investment, and ethics and compliance standards. In addition, from 2013 to 2017, as Eli Lilly’s European Federation of Pharmaceutical Industries and Associations R&D representative, Dr. Clarke was a member of the Research Directors Group and championed Lilly’s strategic engagement and leadership of 32 European Union Innovative Medicine Initiative projects. From 2013 to 2017, he served as Board Member for Eli Lilly and Company Ltd. UK and was a member of the Innovation Board of the Association of the British Pharmaceutical Industry. From 2020 to present, Dr. Clarke served as a mentor to student entrepreneurs at the MIT Sandbox Innovation Fund Program. Dr. Clarke has a Ph.D. in organic chemistry from Imperial College, London, and a Bachelor of Science in organic chemistry from University of Liverpool.

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.

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

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 – Voyager Announces Agreement for Binance.US to Acquire Its Assets

Research, News, and Market Data on VYGVQ

Dec 19, 2022, 08:00 ET

NEW YORK, Dec. 19, 2022 /CNW/ — Voyager Digital Ltd. (“Voyager” or the “Company”) (OTC Pink VYGVQ; FRA: UCD2) announced today that its operating company Voyager Digital LLC selected U.S. exchange BAM Trading Services Inc. (doing business as “Binance.US”) as the highest and best bid for its assets after a review of strategic options with the core objective of maximizing the value returned to customers and other creditors on an expedited timeframe.

Binance.US is headquartered in Palo Alto, CA, and is incorporated in Delaware. It is an independent legal entity and has a licensing agreement with Binance.com.

The Binance.US bid, which sets a clear path forward for Voyager customer funds to be unlocked as soon as possible, is valued at approximately $1.022 billion and is comprised of (i) the fair market value of Voyager’s cryptocurrency portfolio at a to-be-determined date in the future, which at current market prices is estimated to be $1.002 billion, plus (ii) additional consideration equal to $20 million of incremental value. The Company’s claims against Three Arrows Capital remain with the bankruptcy estate, and any future recovery on these and other non-released claims will be distributed to the estate’s creditors.

The Binance.US bid aims to return crypto to customers in kind, in accordance with court-approved disbursements and platform capabilities.

Binance.US will make a $10 million good faith deposit and will reimburse Voyager for certain expenses up to a maximum of $15 million. Should the deal not close by April 18, 2023 subject to a one-month extension, the agreement allows Voyager to immediately move to return value to customers.

Voyager Digital LLC will seek Bankruptcy Court approval to enter into the asset purchase agreement between Voyager Digital LLC and Binance.US at a hearing on January 5, 2023. The sale to Binance.US will be consummated pursuant to a Chapter 11 plan, which will be subject to a creditor vote and is subject to other customary closing conditions. Binance.US and the Company will work to close the transaction promptly following approval of the chapter 11 plan by the Bankruptcy Court.

This sale agreement follows Voyager’s July 5, 2022 entrance into a voluntary restructuring process aimed at returning maximum value to customers. Additional information about the timeline and customer access to crypto will be shared as it becomes available. A copy of the asset purchase agreement and other pleadings filed in this case may be obtained free of charge by visiting the Voyager case website https://cases.stretto.com/Voyager.

Voyager was advised by Kirkland & Ellis LLP, Moelis & Company LLC, and Berkeley Research Group. Binance.US was advised by Latham & Watkins LLP.

Forward Looking Statements
Certain information in this press release, including, but not limited to, statements regarding the Chapter 11 Plan, the proposed transaction with Binance.US, the timeline for the proposed transaction with Binance.US, the approvals required for the proposed transaction with Binance.US the activities on the Binance.US platform following the closing of the proposed transaction with Binance.US, including the coins that will be supported, the listing review of the VGX token and the future sale of the private keys related to the VGX Token Smart Contracts, may constitute forward looking information (collectively, forward-looking statements), which can be identified by the use of terms such as “may,” “will,” “should,” “expect,” “anticipate,” “project,” “estimate,” “intend,” “continue” or “believe” (or the negatives) or other similar variations. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Voyager’s actual results, performance or achievements to be materially different from any of its future results, performance or achievements expressed or implied by forward-looking statements. Moreover, the crypto marketplace is a rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on the Chapter 11 process or the proposed transaction or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties, and assumptions, the future events and trends discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Forward looking statements are subject to the risks, including those risks contained in the Company’s public filings, including in its Management Discussion and Analysis and its Annual Information Form (AIF). Factors that could cause actual results of the Company and its businesses to differ materially from those described in such forward-looking statements include, but are not limited to, a decline in the digital asset market or general economic conditions; changes in laws or approaches to regulation, an adverse development with respect to an issuer or party to the transaction or failure to obtain a required regulatory approvals. Forward-looking statements, past and present performance and trends are not guarantees of future performance, accordingly, you should not put undue reliance on forward-looking statements, current or past performance, or current or past trends. Information identifying assumptions, risks, and uncertainties relating to the Company are contained in its filings with the Canadian securities regulators available at www.sedar.com. The forward-looking statements in this press release are applicable only as of the date of this release or as of the date specified in the relevant forward-looking statement and the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after that date or to reflect the occurrence of unanticipated events, except as required by law. The Company assumes no obligation to provide operational updates, except as required by law. If the Company does update one or more forward-looking statements, no inference should be drawn that it will make additional updates with respect to those or other forward-looking statements, unless required by law. Readers are cautioned that past performance is not indicative of future performance and current trends in the business and demand for digital assets may not continue and readers should not put undue reliance on past performance and current trends.

SOURCE Voyager Digital Ltd.

For further information: Contacts: Voyager Digital, Ltd., Voyager Public Relations Team, [email protected]

Release – Eagle Bulk Shipping Inc. Announces Transfer of Listing to the New York Stock Exchange

Research, News, and Market Data on EGLE

December 19, 2022 at 9:01 AM EST

STAMFORD, Conn., Dec. 19, 2022 (GLOBE NEWSWIRE) — Eagle Bulk Shipping Inc. (NASDAQ: EGLE) (“Eagle Bulk”, “Eagle”, or the “Company”), one of the world’s largest owner-operators within the midsize drybulk segment, today announced that it will transfer the listing of its shares from the Nasdaq Global Select Market (“Nasdaq”) to the New York Stock Exchange (“NYSE”). Eagle expects to commence trading as a NYSE-listed company at market open on January 4, 2023 under its existing ticker symbol, “EGLE”. The Company’s shares will continue to trade on the Nasdaq until the market close on January 3, 2023.

Eagle’s CEO Gary Vogel commented, “We are truly excited to join the New York Stock Exchange and have our shares trade alongside some of the world’s most respected companies, including the majority of our U.S.-listed peers within the maritime/shipping space. We believe listing on the NYSE will further improve our trading liquidity and overall standing within the financial markets, enhancing value for our shareholders.”

“We’re thrilled to welcome Eagle Bulk to the NYSE, the world’s premier listing venue for maritime companies,” said John Tuttle, Vice Chair, NYSE Group.

About Eagle Bulk Shipping Inc.

Eagle Bulk Shipping Inc. (“Eagle” or the “Company”) is a US-based fully integrated shipowner-operator providing global transportation solutions to a diverse group of customers including miners, producers, traders, and end users. Headquartered in Stamford, Connecticut, with offices in Singapore and Copenhagen, Eagle focuses exclusively on the versatile midsize drybulk vessel segment and owns one of the largest fleets of Supramax / Ultramax vessels in the world. The Company performs all management services in-house (including: strategic, commercial, operational, technical, and administrative) and employs an active management approach to fleet trading with the objective of optimizing revenue performance and maximizing earnings on a risk-managed basis. For further information, please visit our website: www.eagleships.com.

Investor and Media Contact
[email protected]  
+1 203 276 8100

Forward-Looking Statements

Matters discussed in this release may constitute forward-looking statements that may be deemed to be “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements reflect current views with respect to future events and financial performance and may include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts. These statements may include words such as “believe,” “estimate,” “project,” “intend,” “expect,” “plan,” “anticipate,” and similar expressions in connection with any discussion of the timing or nature of future operating or financial performance or other events.

The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, examination of historical operating trends, data contained in our records and other data available from third parties. Although Eagle Bulk Shipping Inc. believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, Eagle Bulk Shipping Inc. cannot assure you that it will achieve or accomplish these expectations, beliefs or projections.

Risks and uncertainties are further described in reports filed by Eagle Bulk Shipping Inc. with the Securities and Exchange Commission.

Source: Eagle Bulk Shipping Inc.

Release – Cocrystal Pharma Reports Highly Favorable Safety and Tolerability Results from a Phase 1 Study with its Oral Antiviral CC-42344 for the Treatment of Pandemic and Seasonal Influenza A

Research, News, and Market Data on COCP

DECEMBER 19, 2022

BOTHELL, Wash., Dec. 19, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces highly favorable safety and tolerability results for its orally administered replication inhibitor CC-42344 in its Phase 1 study. CC-42344 is a broad-spectrum antiviral for the treatment of pandemic and seasonal influenza A with a novel mechanism of action. The randomized, double-controlled Phase 1 study was conducted in Australia to evaluate the safety, tolerability and pharmacokinetics (PK) of CC-42344 given orally at single doses up to 800 mg and daily doses up to 14 days in 56 healthy volunteers.

Approximately 50% of the participants who received a single dose of CC-42344 across all dose levels (100 to 800 mg) experienced adverse events, similar to the proportion of placebo subjects who also experienced adverse events. In the multiple-dose section of the study, the incidence of adverse events was 67% for both CC-42344 (50 to 200 mg) and placebo. The vast majority of adverse events were mild in severity. The most frequently reported adverse event was headache, which occurred at similar rates in CC-42344-treated and placebo-treated participants. There were no serious adverse events or drug discontinuation due to adverse events. 

“We are encouraged by the highly favorable safety and tolerability results from this first-in-human study with CC-42344. These findings give us confidence to continue our clinical testing of this compound as a potential treatment for pandemic and seasonal influenza A,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “With these results our influenza A program has achieved a major milestone and we look forward to beginning a Phase 2a clinical study.”

Cocrystal plans to apply to the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct a Phase 2a human challenge study in early 2023. Subject to regulatory clearance, the study is expected to be initiated in the second half of 2023.

“On average about 8 percent of the U.S. population contracts influenza each season according to the Centers for Disease Control and Prevention. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits in the U.S. annually. We are highly focused on advancing CC-42344 through the clinical process and toward making a meaningful contribution to improving health and reducing the cost of care,” said James Martin, Cocrystal’s CFO and interim Co-CEO. 

About CC-42344
CC-42344 is an oral PB2 inhibitor discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. It is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly conserved regions common to multiple influenza strains. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®, while also demonstrating favorable PK and safety profiles.

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 potential of CC-42344 for the treatment of seasonal and pandemic influenza, and our expectations and plans to submit an application to the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct a Phase 2a human challenge study in early 2023 and to initiate the Phase 2a 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 any future impact of COVID-19 (including long-term or pervasive effects of the virus), inflation, interest rate increases and the war in Ukraine on the U.K. and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our influenza A program, the ability of the contract research organization to recruit patients into clinical trials, the results of future preclinical and clinical studies, and general risks arising from clinical trials. 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, 2021. 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 December 19, 2022