Release – Snail’s Innovates Development Pipeline with AI Technology

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February 27, 2024 at 8:00 AM EST

CULVER CITY, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, today announced its strategic integration of AI technology into its game development process, marking a significant step in gaming innovation.

By consistently evaluating the latest AI tools, Snail Games is introducing pivotal advancements in game development. The Company is transforming the art pipeline with cutting-edge text-to-3D model technology and pioneering the generation of resources and biomes on a planetary scale. These AI-driven innovations are not only enhancing development efficiency but also enabling the creation of more immersive and engaging gaming worlds. Central to Snail Games’ philosophy is the player-first approach, ensuring quality and cost optimization to deliver unparalleled, yet accessible gaming experiences.

This player-first approach is evident in Snail Games’ recent initiatives. The launch of Zombie Within, a horror-infused social deduction game, and the ARK Survival Ascended’s Premium Mods program both demonstrate the Company’s dedication to listening to player feedback and enriching player experiences through innovative development. Zombie Within continues the legacy of Snail’s popular social deduction game ‘West Hunt.’ Additionally, the Premium Mods program for ARK Survival Ascended represents a forward-thinking approach to community engagement, rewarding modder creativity and empowering player interaction. Offering creators an industry-leading 50% share of revenue generated, Snail Games aims to incentivize innovation and encourage the development of high-quality mods that enhance the gaming experience and gives players the opportunity to help shape the ARK franchise.

“Our evaluation and integration of AI technology into our development process is a step forward in our mission to deliver high-quality, engaging, and accessible games,” said Jim Tsai, CEO of Snail, Inc. “Our major endeavors are grounded in our player-first strategy and our exploration of new frontiers in game development.”

About Snail, Inc.

Snail, Inc. is a leading global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PC’s and mobile devices.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful, including the launch of ARK: Survival Ascended, ARK: The Animated Series and ARK 2; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other game developers and publishers and both large and small, public and private Internet companies; its relationships with third-party platforms such as Xbox Live and Game Pass, PlayStation Network, Steam, Epic Games Store, the Apple App Store, the Google Play Store, My Nintendo Store and the Amazon Appstore; expectations for future growth and performance; and assumptions underlying any of the foregoing.

Contacts:

Investors:
investors@snail.com

Press:
media@snail.com

Release – Tonix Pharmaceuticals Announces Positive Results from Clinical Pharmacokinetic Bridging Study of Tonmya™ to Support Development and Partnering in Japan and China

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February 27, 2024 8:00am ESTDownload as PDF

Tonix plans to File a Clinical Trial Notification (CTN) in Japan and Investigational New Drug (IND) application in China to support a registration-enabling Asian Phase 3 study without dosage adjustment based on U.S. registrational Phase 3 data

Tonmya’s market exclusivity is supported by issued patents in Japan, China, Hong Kong and Taiwan; cyclobenzaprine is a new chemical entity in Japan and China

New Drug Application (NDA) submission to the U.S. FDA for the approval of Tonmya for the management of fibromyalgia planned for second half of 2024

CHATHAM, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced positive results from its clinical pharmacokinetic (PK) bridging study of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in healthy adult male and female ethnic Japanese and Chinese volunteers. Results indicate that key pharmacokinetic parameters of cyclobenzaprine are comparable in ethnic Japanese and Chinese volunteers to Caucasian volunteers from a prior PK study. Tonmya was generally well tolerated in the ethnic Japanese and Chinese healthy volunteers. The company expects these data to fulfill the requirement for a bridging study, and to support regulatory filings for clinical studies in Japan and China where cyclobenzaprine is a new chemical entity (NCE). Tonix holds issued patents for market exclusivity rights of Tonmya in Japan, China, Hong Kong and Taiwan.

This study characterized the PK profile and dose proportionality of Tonmya following administration in 20 healthy volunteers of documented Japanese or Chinese ancestry, and compared these findings to an existing PK dataset conducted under similar conditions in Caucasian volunteers.

“This bridging study is an important first step as we begin evaluating the potential for approval and marketing Tonmya in Japan and China. The results show a similar pharmacokinetic profile in ethnic Japanese and Chinese volunteers with a Caucasian comparator group,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “As a result, we believe that these data, with supporting results recently reported from the positive Phase 3 RESILIENT study, are the only clinical data needed to support regulatory filings in Japan and China.”

Dr. Lederman continued, “With patents issued in Japan, China, Hong Kong and Taiwan expected to provide market exclusivity into 2034, we believe that Tonmya would be a welcome addition to the therapeutic options for fibromyalgia patients in East Asia and an attractive asset for the right development and commercialization partners in these markets. Cyclobenzaprine is an NCE in both of these countries. We plan to meet with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) to seek agreement on the development of Tonmya in Japan and China, respectively.”

About the Asia Bridging Study

The study was a randomized, single-dose, open-label, 2-way, crossover study design in ethnic Japanese (N=10) and Chinese (N=10) healthy male and female volunteers. The primary objective of the study was to characterize the PK profile and dose proportionality of Tonmya following administration of 2.8 mg and 5.6 mg (one and two 2.8 mg tablets) under fasting conditions in Japanese and Chinese volunteers, and to retrospectively compare these PK data with existing PK data of both cyclobenzaprine and norcyclobenzaprine from a prior Phase 1 study in Caucasian volunteers dosed under the same conditions. Safety and tolerability were also assessed. A 2.8 mg or 5.6 mg dose (2 X 2.8 mg tablet) of Tonmya was administered sublingually in the morning under fasted conditions. Blood samples were collected pre-dose and up to 15 days post-dose for analyte measurements, with a 28-day washout between periods. The primary PK endpoints were the total amount of cyclobenzaprine and metabolite norcyclobenzaprine in the blood (expressed as the area under the curve (AUC0-T)) and maximum concentration (expressed as Cmax).

Study Results

Pharmacokinetics
Ethnic Japanese and Chinese volunteers were considered comparable on PK parameters for cyclobenzaprine following a 2.8 mg and 5.6 mg dose of Tonmya, and dose proportionality was demonstrated in both samples. Given that the similarity in PK profile between Japanese and Chinese volunteers was confirmed, the PK data from the two ethnic groups were pooled for the comparison between Asian (n=20) and Caucasian (n=16) volunteers. The PK parameters of cyclobenzaprine for Japanese, Chinese, and Caucasian groups were similar, with geometric mean ratios falling within the 90% confidence interval.

Safety

  • Tonmya was shown to be safe and well-tolerated at doses up to 5.6 mg as single sublingual administrations in healthy adult Japanese and Chinese volunteers.
  • The incidence of adverse events (AEs) and investigational product-related AEs was low. No volunteer discontinued due to an AE.
  • No clinically significant abnormal findings in laboratory parameters, ECGs, or other safety assessments were noted during the study. No severe AEs and no deaths were reported during the study.

Issued Patents in Japan, China, Hong Kong and Taiwan

EUTECTIC FORMULATIONS









CountryPatent NumberExpected Expiry
ChinaZL 201480024011.103/14/2034
ChinaZL201910263541.603/14/2034
Hong KongHK121872703/14/2034
Japan631054203/14/2034
Taiwan R.O.C.I66182503/14/2034
TRANSMUCOSAL ABSORPTION







Japan625945206/14/2033
Taiwan R.O.C.I59082006/14/2033
Taiwan R.O.C.I68366006/14/2033
Taiwan R.O.C.I64242906/14/2033
Hong Kong120936106/14/2033

About Tonmya* (also known as TNX-102 SL)

Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the Company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.

Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia.

*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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

Forward Looking Statements

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

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released February 27, 2024

Release – QuantaSing to Report Second Fiscal Quarter Financial Results on March 7, 2024

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February 27, 2024

PDF Version

BEIJING, Feb. 27, 2024 (GLOBE NEWSWIRE) — QuantaSing Group Limited (NASDAQ: QSG) (“QuantaSing” or the “Company”), a leading online learning service provider in China, today announced that it plans to release its unaudited financial results for the quarter ended December 31, 2023, before the U.S. market opens on Thursday, March 7, 2024.

The Company’s management will hold an earnings conference call at 07:00 A.M. Eastern Time on Thursday, March 7, 2024 (08:00 P.M. Beijing Time on the same day) to discuss the financial results.

Listeners may access the call by dialing the following numbers:
International:
United States Toll Free:
Mainland China Toll Free: 
Hong Kong Toll Free:
Conference ID:
1-412-902-4272
1-888-346-8982
4001-201203
800-905945
QuantaSing Group Limited
  
The replay will be accessible through March 14, 2024 by dialing the following numbers:
International:
United States Toll Free:
Replay Access Code:
1-412-317-0088
1-877-344-7529
8029802
  

A live and archived webcast of the conference call will also be available at the Company’s investor relations website at https://ir.quantasing.com.

About QuantaSing Group Limited
QuantaSing is a leading online service provider in China dedicated to improving people’s quality of life and well-being by providing lifelong personal learning and development opportunities. The Company is the largest service provider in China’s online adult learning market and China’s adult personal interest learning market in terms of revenue, according to a report by Frost & Sullivan based on data from 2022. By leveraging its proprietary tools and technology, QuantaSing offers easy-to-understand, affordable, and accessible online courses to adult learners under a variety of brands, including QiNiu, JiangZhen, and QianChi, empowering users to pursue personal development. Leveraging its extensive experience in individual online learning services, the Company has also expanded its services to corporate clients including, among others, marketing services and enterprise talent management services.

For more information, please visit: https://ir.quantasing.com.

Contact
Investor Relations
Leah Guo
QuantaSing Group Limited
Email: ir@quantasing.com
Tel: +86 (10) 6493-7857

Robin Yang, Partner
ICR, LLC
Email: QuantaSing.IR@icrinc.com
Phone: +1 (212) 537-0429

Public Relations
Brad Burgess, Senior Vice President
ICR, LLC
Email: Brad.Burgess@icrinc.com

Release – Alvopetro Announces 2023 Year End Reserves

Research News and Market Data on ALVOF

Feb 26, 2024

CALGARY, AB, Feb. 26, 2024 /CNW/ – Alvopetro Energy Ltd. (TSXV:ALV) (OTCQX: ALVOF) announces our reserves as at December 31, 2023 with total proved plus probable (“2P”) reserves of 8.7 MMboe and a before tax net present value discounted at 10% (“NPV10”) of $309.7 million, risked best estimate contingent resources of 5.4 MMboe (NPV10 $126.1 million) and risked best estimate prospective resources of 9.6 Mmboe (NPV10 $184.9 million).  The reserves and resources data set forth herein is based on an independent reserves and resources assessment and evaluation prepared by GLJ Ltd. (“GLJ”) dated February 26, 2024 with an effective date of December 31, 2023 (the “GLJ Reserves and Resources Report”).  

The GLJ Reserves and Resources Report incorporates Alvopetro’s working interest share of remaining recoverable reserves held by Alvopetro in the Caburé and Murucututu natural gas fields and the Bom Lugar and Mãe-da-lua oil fields as well as Alvopetro’s working interest share of remaining recoverable resources held by Alvopetro in the Murucututu natural gas field. With respect to Murucututu, Bom Lugar, and Mãe-da-lua, Alvopetro’s working interest share is 100%. With respect to the unitized area (the “Unit”) which includes our Caburé and Caburé Leste fields (collectively referred to as “Caburé” in this news release) and two fields held by our third-party partner in the Unit, Alvopetro’s working interest share as of December 31, 2023 was 49.1%, with the remaining 50.9% held by our partner. As previously announced by the Company, the first redetermination of the working interests to each party commenced in the fourth quarter of 2023. The parties engaged an independent expert (the “Expert”) to evaluate the redetermination. Pursuant to the provisions of the UOA, where an Expert is engaged, the Expert’s determination shall be made using what is commonly referred to as the “pendulum” method of dispute resolution. Under this method, the Expert is not required or permitted to provide their own interpretation but is required to select the single Final Proposal (between the two partner’s respective Final Proposals), which, in the Expert’s opinion, provides the most technically justified result of the application of the relevant information and data and material provided to the Expert consistent with the UOA and all related documents. As of the date of this news release, the outcome of the Expert’s decision and the resulting working interest to Alvopetro following the decision is uncertain. The resulting impact on Alvopetro’s reserves and future cash flows may be material and may have a material adverse effect on Alvopetro. The impact on Alvopetro’s working interest will be effective on the first calendar day of the second month following the date of the decision of the Expert, subject to any government approvals that may be required. The decision of the Expert is expected near the end of the first quarter of 2024. The GLJ Reserves and Resource Report and the references included herein are based on the 49.1% interest in Caburé, Alvopetro’s working interest share as of December 31, 2023. The reserves data included in this news release and in the GLJ Reserves and Resources Report may be materially impacted following the Expert’s decision.

All references herein to $ refer to United States dollars, unless otherwise stated.

December 31, 2023 GLJ Reserves and Resource Report:

  • Proved reserves (“1P”) decreased 30% to 2.7 MMboe Proved reserves mainly due to 2023 production and technical revisions related to the 197-1 and 183-1 Murucututu wells. Alvopetro is working to enhance production from these wells with optimizations in 2024.
  • 2P reserves decreased 4% from 9.0 to 8.7 MMboe after 0.8 MMboe of production in 2023. Production in 2023 was offset by improved recovery factors at Caburé due to the agreed Unit development plan and new additions associated with the discovery at the 183-A3 well in the Caruaçu Formation.
  • Proved plus Probable plus Possible reserves (“3P”) increased to 15.2 MMboe from 14.4 MMboe as a result of additions associated with the discovery at the 183-A3 well in the Caruaçu Formation.
  • 2P NPV10 decreased 11% to $309.7 million due to changes in forecast natural gas prices and 2023 production offset mainly by additional value associated with discovered zones in the Caruaçu Formation on our Murucututu natural gas field.
  • Risked best estimate contingent resources increased from 2.9 MMboe to 5.4 MMboe at December 31, 2023 with a NPV10 of $126.1 million, increases from December 31, 2022 of 84% and 103% respectively. The increases were associated with the discovery at the 183-A3 well in the Caruaçu Formation.
  • Risked best estimate prospective resources decreased from 12.5 MMboe to 9.6 MMboe with a NPV10 of $184.9 million, decreases of 23% and 29% respectively from December 31, 2022. The decrease was due primarily to adjustments to the probabilistic models incorporating the logs results for the Gomo zone at the 183-A3 well.

SUMMARY

December 31, 2023 Gross Reserve and Gross Resource Volumes: (1)(2)(3)(4)(5)(6)

December 31, 2023 Reserves (Gross)Total Proved (1P)Total Proved plus Probable (2P)Total Proved plus Probable plus Possible (3P)
(Mboe)(Mboe)(Mboe)
Caburé Natural Gas Field 1,9953,7004,853
Murucututu Natural Gas Field5824,5599,679
Bom Lugar Oil Field126415622
Mãe-da-lua Oil Field233653
Total Company Reserves2,7278,71115,208
December 31, 2023 Murucututu Resources (Gross)Low EstimateBest Estimate High Estimate
(Mboe)(Mboe)(Mboe)
Risked Contingent Resource Risked Prospective Resource                                                                          3,500 4,7905,356 9,6465,919 15,222
See ‘Footnotes’ section at the end of this news release

Net Present Value Before Tax Discounted at 10%:(1)(2)(3)(4)(5)(6)(7)(8)

Reserves1P2P3P
($000s)($000s)($000s)
Caburé Natural Gas Field99,946170,854212,653
Murucututu Natural Gas Field11,700129,169254,433
Bom Lugar Oil Field3,9788,94013,798
Mãe-da-lua Oil Field2626941,189
Total Company115,886309,657482,073
Murucututu ResourceLow EstimateBest Estimate High Estimate
($000s)($000s)($000s)
Risked Contingent Resource Risked Prospective Resource82,489 77,906126,134 184,859133,884 304,997
See ‘Footnotes’ section at the end of this news release

PRICING ASSUMPTIONS – FORECAST PRICES AND COSTS 

GLJ employed the following pricing and inflation rate assumptions as of January 1, 2024 in the GLJ Reserves and Resources Report in estimating reserves and resources data using forecast prices and costs.

Year  Brent Blend Crude Oil FOB North Sea ($/Bbl)National Balancing Point (UK) ($/MMBtu)NYMEX Henry HubNear Month Contract ($/MMBtu)Alvopetro-Bahiagas Gas Contract $/MMBtu (Current Year)Alvopetro-BahiagasGas Contract $/MMBtu (Previous Year)    Change from prior year
202477.0011.112.7510.5610.96-3.6 %
202579.5013.003.8510.0810.79-6.6 %
202681.4911.854.1610.4411.01-5.2 %
202782.5810.754.2510.5111.12-5.5 %
202884.1910.984.3310.4810.75-2.5 %
202985.9011.204.4210.6310.73-0.9 %
203087.6411.434.5010.8210.88-0.6 %
203189.3711.654.6011.0411.09-0.5 %
203291.1611.894.6911.2611.30-0.4 %
2033*92.9812.124.7811.4811.53-0.4 %
*Escalated at 2% per year thereafter

As of February 1, 2024, Alvopetro’s contracted natural gas price under the terms of our long-term gas sales agreement is based on the ceiling price within the contract. Pricing is forecast to stay slightly below the ceiling for future price adjustments. The ceiling price incorporates assumed US inflation of 2%.

GLJ RESERVES AND RESOURCES REPORT 

The GLJ Reserves and Resources Report has been prepared in accordance with the standards contained in the Canadian Oil and Gas Evaluation Handbook (the “COGE Handbook”) that are consistent with the standards of National Instrument 51-101 (“NI 51-101”). GLJ is a qualified reserves evaluator as defined in NI 51-101. The GLJ Reserves and Resources Report was an evaluation of all reserves of Alvopetro including our working interest share as of December 31, 2023 of the Unit (referred to herein as the Caburé natural gas field), our Murucututu natural gas project, as well as our Bom Lugar and Mãe-da-lua oil fields. The GLJ Reserves and Resources Report also includes an evaluation of the gas resources of our Murucututu natural gas field.  In addition to the reserves assigned to our Murucututu field, contingent resource was assigned to the area in proximity to our existing Murucututu reserves, deemed to be discovered.  The area mapped by 3D seismic west and north of the area defined as contingent was assigned prospective resource. Additional reserves and resources information as required under NI 51-101 will be included in the Company’s Annual Information Form for the 2023 fiscal year which will be filed on SEDAR+ (www.sedarplus.ca) by April 30, 2024.

December 31, 2023 Reserves Information:

Summary of Reserves (1)(2)(3)

Light & Medium OilConventional Natural GasNatural Gas LiquidsOil Equivalent
Company GrossCompany NetCompany GrossCompany NetCompany GrossCompany NetCompany GrossCompany Net
(Mbbl)(Mbbl)(MMcf)(MMcf)(Mbbl)(Mbbl)(Mboe)(Mboe)
Proved
Producing8711,46011,0001221172,0391,957
Developed Non-Producing142133142133
Undeveloped2,9512,8185452546522
Total Proved15014014,41113,8181761692,7272,612
      Probable30228531,17529,8594864655,9835,726
Total Proved plus Probable45142545,58643,6776626348,7118,338
      Possible22421134,25332,7855655406,4976,215
Total Proved plus Probable plus Possible67563579,83976,4621,2261,17415,20814,553
See ‘Footnotes’ section at the end of this news release

Summary of Before Tax Net Present Value of Future Net Revenue – $000s (1)(2)(3)(7)(8)

Undiscounted5 %10 %15 %20 %
Proved
Producing114,762106,922100,20494,36489,230
Developed Non-Producing6,3375,1574,2573,5703,040
Undeveloped18,15514,37111,4259,1817,467
Total Proved139,254126,450115,886107,11599,738
       Probable391,202263,064193,771151,218122,597
Total Proved plus Probable530,456389,514309,657258,333222,335
       Possible538,835271,641172,416124,47596,580
Total Proved plus Probable plus Possible1,069,291661,155482,073382,808318,915
See ‘Footnotes’ section at the end of this news release

Summary of After Tax Net Present Value of Future Net Revenue – $000s (1)(2)(3)(7)(8)

Undiscounted5 %10 %15 %20 %
Proved
Producing107,434100,32094,20988,88684,200
Developed Non-Producing5,6234,5523,7283,0982,613
Undeveloped14,19111,4549,1927,4126,022
Total Proved127,248116,326107,12999,39692,834
       Probable297,522205,240153,457120,74898,250
Total Proved plus Probable424,769321,565260,586220,145191,085
       Possible388,926204,696133,88598,38677,076
Total Proved plus Probable plus Possible813,695526,262394,471318,531268,160
See ‘Footnotes’ section at the end of this news release

Future Development Costs (1)(2)(3)(7)(8)

The table below sets out the total development costs deducted in the estimation of future net revenue attributable to proved reserves, proved plus probable reserves and proved plus probable plus possible reserves (using forecast prices and costs), by field, in the GLJ Reserves and Resources Report. Total development costs include capital costs for drilling and completing wells and for facilities but excludes abandonment and reclamation costs.

The future development costs for the Caburé field include Alvopetro’s working interest share (49.1%) for three development wells in the proved category and an additional two development wells in the probable and possible categories. Also included in future development costs for Caburé are costs associated with a facilities upgrade planned at the field for compression of natural gas to be delivered to Alvopetro’s natural gas processing facility. In prior years, Alvopetro reflected all equipment rental payments associated with our Gas Treatment Agreement with Enerflex Ltd. as part of future development costs; however in 2023, such costs are now incorporated within operating expense along with other operating costs associated with the agreement. The future costs associated with equipment rental are also reflected as a capital lease obligation on our financial statements.

The future development costs for the Murucututu field in the proved category include one development well and stimulation costs for the 183-1 and 183-A3 wells and one project to improve recovery from the 197(1) well. The probable category also includes an additional two development wells along with additional stimulation projects at the 183-1 and 183-A3 wells. The possible category includes one additional well.

The future development costs for Bom Lugar in the proved category include costs to stimulate the BL-06 well drilled by Alvopetro in 2023. Costs in the probable category also include one development well and costs for facilities upgrade. Future development costs at the Mãe-da-lua field relate to a stimulation of the existing producing well.

Alvopetro’s share of future development costs are summarized as follows:

$000s, Undiscounted20242025202620272028RemainingTotal
Proved
Caburé Natural Gas Field 6,9936,993
Murucututu Gas Field2,0506,8858,935
Bom Lugar Oil Field510510
Mãe-da-lua Oil Field551551
Total Proved9,0437,94616,989
Proved Plus Probable
Caburé Natural Gas Field6,9932,5049,497
Murucututu Gas Field3,95020,65524,605
Bom Lugar Oil Field6,0596,059
Mãe-da-lua Oil Field551551
Total Proved Plus Probable10,94329,76940,712
Proved Plus Probable Plus Possible
Caburé Natural Gas Field6,9932,5049,497
Murucututu Gas Field3,95027,54031,490
Bom Lugar Oil Field6,0596,059
Mãe-da-lua Oil Field551551
Total Proved Plus Probable Plus Possible10,94336,65447,597
See ‘Footnotes’ section at the end of this news release

Reconciliation of Alvopetro’s Gross Reserves (Before Royalty) (1)(2)(3)(8)

    Proved(Mboe)    Probable(Mboe)  Proved Plus Probable(Mboe)    Possible (Mboe)Proved plus Probable plus Possible (Mboe)
December 31, 2022  3,9095,1289,0375,34514,382
Discoveries1,3981,3982,4883,886
Extensions148148(148)
Technical Revisions(400)(690)(1,090)(1,188)(2,278)
Production(782)(782)(782)
December 31, 2023 2,7275,9838,7116,49715,208
See ‘Footnotes’ section at the end of this news release.

December 31, 2023 Murucututu Contingent Resources Information:

Summary of Unrisked Company Gross Contingent Resources (1)(2)(5)(6)

Development Pending Economic Contingent ResourcesLow EstimateBest Estimate High Estimate
Conventional natural gas (MMcf)20,95232,06235,433
Natural gas liquids (Mbbl)386591653
Oil equivalent (Mboe)3,8785,9356,559
See ‘Footnotes’ section at the end of this news release.

Summary of Before Tax Net Present Value of Future Net Revenue of Unrisked Contingent Resources- $000s (1)(2)(5)(6)(7)(8)

Undiscounted5 %10 %15 %20 %
Low Estimate279,201146,11491,40063,32746,651
Best Estimate470,246226,624139,76097,61273,016
High Estimate540,860246,103148,348102,78176,691
See ‘Footnotes’ section at the end of this news release.

The GLJ Contingent Resource Report for Murucututu assumes capital deployment starting in 2025 for the drilling and completion of wells with total project costs of $20.8 million and first commercial production in 2025. The information presented herein is based on company net project development costs. The recovery technology assumed for purposes of the estimate is based on established technologies utilized repeatedly in the industry.

There can be no certainty that the project will be developed on the timelines discussed herein. The project is based on a pre-development study. Development of the project is dependent on several contingencies as further described in this news release. Significant positive factors relevant to the estimate include existing production in close proximity, proximity to infrastructure, existing long-term gas sales agreement and corporate commitment to the project. Significant negative factors relevant to the estimate include reservoir performance and the economic viability of the project (with sensitivity to low commodity prices), access to and amount of capital required to develop resources at an acceptable cost, and regulatory approvals for planned activities including stimulations and new infrastructure developments.

Summary of Development Pending Risked Company Gross Contingent Resources(1)(2)(5)(6)

The GLJ Reserves and Resources Report estimates the Chance of Development as the product of two main contingencies associated with the project development, which are: 1) the probability of corporate sanctioning, which GLJ estimates at 95%; 2) the probability of finalization of a development plan, which GLJ estimates at 95%. The product of these two contingencies is 90%.   As there is no risk related to discovery, the Chance of Commerciality for the contingent resource is therefore 90% which is the risk factor that has been applied to the Development Risked company gross contingent resources and the net present value figures reported below.

Low EstimateBest Estimate High Estimate
Conventional natural gas (MMcf)18,90928,93631,978
Natural gas liquids (Mbbl)349533590
Oil equivalent (Mboe)3,5005,3565,919
See ‘Footnotes’ section at the end of this news release.

Summary of Development Pending Risked Before Tax Net Present Value of Future Net Revenue of Contingent Resources- $000s(1)(5)(6)(7)(8)

Undiscounted5 %10 %15 %20 %
Low Estimate251,978131,86882,48957,15342,102
Best Estimate424,397204,528126,13488,09565,897
High Estimate488,126222,108133,88492,76069,214
See ‘Footnotes’ section at the end of this news release.

December 31, 2023 Murucututu Prospective Resources Information:

Summary of Unrisked Company Gross Prospective Resources (1)(2)(4)(6)

Prospective ResourcesLowBestHigh
Conventional natural gas (MMcf)31,90364,251101,392
Natural gas liquids (Mbbl)5881,1841,869
Oil equivalent (Mboe)5,90511,89318,768
See ‘Footnotes’ section at the end of this news release.

Summary of Before Tax Net Present Value of Future Net Revenue of Unrisked Prospective Resources – $000s (1)(4)(6)(7)(8)

Undiscounted5 %10 %15 %20 %
Low Estimate395,126179,91196,05256,09434,354
Best Estimate959,658413,788227,919142,78596,201
High Estimate1,628,234680,308376,039240,051165,845
See ‘Footnotes’ section at the end of this news release.

The GLJ Reserves and Resources Report for Murucututu prospective resources assumes capital deployment starting in 2026 for the drilling and completion of wells and pipeline expansion costs, with total project costs of $75.8 million and first commercial production in 2026. The information presented herein is based on company project development costs. The recovery technology assumed for purposes of the estimate is based on established technologies utilized repeatedly in the industry.

There can be no certainty that the project will be developed on the timelines discussed herein. Development of the project is dependent on several contingencies as further described in this news release. The project is based on a conceptual study. Significant positive factors relevant to the estimate include existing production in close proximity, proximity to infrastructure, existing long-term gas sales agreement and corporate commitment to the project. Significant negative factors relevant to the estimate include reservoir performance and the economic viability of the project (with sensitivity to low commodity prices), access to and amount of capital required to develop resources at an acceptable cost, and regulatory approvals for planned activities including stimulations and new infrastructure developments.

Summary of Development Risked Company Gross Prospective Resources(1)(2)(4)(6)

The GLJ Reserves and Resources Report estimates the Chance of Commerciality as the product between the Chance of Discovery and the Chance of Development. The Chance of Discovery of the prospective resources has been assessed at 90%, while the Chance of Development has been assessed as the same as for the Contingent Resources described above at 90%. The resulting Chance of Commerciality is 81%, which has been applied to the company gross unrisked prospective resources and the net present value figures reported below.  

LowBestHigh
Conventional natural gas (MMcf)25,87652,11282,237
Natural gas liquids (Mbbl)4779611,516
Oil equivalent (Mboe)4,7909,64615,222
See ‘Footnotes’ section at the end of this news release.

Summary of Development Risked Before Tax Net Present Value of Future Net Revenue of Prospective Resources- $000s(1)(4)(6)(7)(8)

Undiscounted5 %10 %15 %20 %
Low Estimate320,477145,92277,90645,49727,864
Best Estimate778,356335,614184,859115,81078,027
High Estimate1,320,623551,782304,997194,700134,513
See ‘Footnotes’ section at the end of this news release.

Upcoming 2023 Results and Live Webcast

Alvopetro anticipates announcing its 2023 fourth quarter and year-end results on March 19, 2024 after markets close and will host a live webcast to discuss the results at 8:00am Mountain time, on March 20, 2024. Details for joining the event are as follows:

DATE: March 20, 2024TIME: 8:00 AM Mountain/10:00 AM EasternLINK: https://us06web.zoom.us/j/83279531812 https://us06web.zoom.us/j/83920744797 DIAL-IN NUMBERS: https://us06web.zoom.us/u/kdcVycQytc WEBINAR ID: 839 2074 4797

The webcast will include a question-and-answer period. Online participants will be able to ask questions through the Zoom portal. Dial-in participants can email questions directly to socialmedia@alvopetro.com.

Corporate Presentation

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

FOOTNOTES

(1)References to Company Gross reserves or Company Gross Resources means the total working interest share of remaining recoverable reserves or resources held by Alvopetro before deductions of royalties payable to others and without including any royalty interests held by Alvopetro.  With respect to the Caburé natural gas field, Alvopetro’s working interest was 49.1% as of December 31, 2023 but is subject to redetermination, the first of which is currently underway. The outcome of this redetermination is unknown and the resulting impact on the reserves presented herein may be material.
(2)The tables above are a summary of the reserves of Alvopetro and the net present value of future net revenue attributable to such reserves as evaluated in the GLJ Reserves and Resources Report based on forecast price and cost assumptions. The tables summarize the data contained in the GLJ Reserves and Resources Report and as a result may contain slightly different numbers than such report due to rounding. Also due to rounding, certain columns may not add exactly.
(3)Possible reserves are those additional reserves that are less certain to be recovered than probable reserves.  There is a 10% probability that the quantities actually recovered will equal or exceed the sum of proved plus probable plus possible reserves.
(4)Prospective Resources are defined in the COGE Handbook as those quantities of petroleum estimated, as of a given date, to be potentially recoverable from undiscovered accumulations by application of future development projects.  Prospective resources have both an associated chance of discovery and a chance of development.  There is no certainty that any portion of the prospective resources will be discovered and even if discovered, there is no certainty that it will be commercially viable to produce any portion. Prospective Resources are further subdivided in accordance with the level of certainty associated with recoverable estimates assuming their discovery as described in footnote 6.
(5)Contingent Resources are defined in the COGE Handbook as those quantities of petroleum estimated, as of a given date, to be potentially recoverable from known accumulations using established technology or technology under development, but are not currently considered to be commercially recoverable due to one or more contingencies. Contingencies may include factors such as economic, legal, environmental, political and regulatory matters or a lack of markets. It is also appropriate to classify as contingent resources the estimated discovered recoverable quantities associated with a project in the early evaluation stage.  Contingent Resources are further classified in accordance with the level of certainty associated with the estimates as described in footnote 6 and may be subclassified based on project maturity and/or characterized by their economic status. The Contingent Resources estimated in the GLJ Reserves and Resources Report are classified as “economic contingent resources”, which are those contingent resources that are currently economically recoverable.  All such resources are further sub-classified with a project status of “development pending”, meaning that resolution of the final conditions for development are being actively pursued. The recovery estimates of the Company’s contingent resources provided herein are estimates only and there is no guarantee that the estimated resources will be recovered. There is uncertainty that it will be commercially viable to produce any portion of the resources. Actual recovered resource may be greater than or less than the estimates provided herein.
(6)Low Estimate: This is considered to be a conservative estimate of the quantity that will actually be recovered. It is likely that the actual remaining quantities recovered will exceed the low estimate. If probabilistic methods are used, there should be at least a 90 percent probability (P90) that the quantities actually recovered will equal or exceed the low estimate.
Best Estimate: This is considered to be the best estimate of the quantity that will actually be recovered. It is equally likely that the actual remaining quantities recovered will be greater or less than the best estimate. If probabilistic methods are used, there should be at least a 50 percent probability (P50) that the quantities actually recovered will equal or exceed the best estimate.
High Estimate: This is considered to be an optimistic estimate of the quantity that will actually be recovered. It is unlikely that the actual remaining quantities recovered will exceed the high estimate. If probabilistic methods are used, there should be at least a 10 percent probability (P10) that the quantities actually recovered will equal or exceed the high estimate.
(7)The net present value of future net revenue attributable to Alvopetro’s reserves and resources are stated without provision for interest costs and general and administrative costs, but after providing for estimated royalties, production costs, development costs, other income, future capital expenditures, well abandonment and reclamation costs for only those wells assigned reserves and material dedicated gathering systems and facilities. The net present values of future net revenue attributable to Alvopetro’s reserves and resources estimated by GLJ do not represent the fair market value of those reserves. Other assumptions and qualifications relating to costs, prices for future production and other matters are summarized herein. The recovery and reserve and resource estimates of the Company’s reserves and resources provided herein are estimates only and there is no guarantee that the estimated reserves and resources will be recovered. Actual reserves and resources may be greater than or less than the estimates provided herein.
(8)GLJ’s January 1, 2024 escalated price forecast is used in the determination of future gas sales prices under Alvopetro’s long-term gas sales agreement and for all forecasted oil sales and natural gas liquids sales. See https://www.gljpc.com/sites/default/files/pricing/Jan24.pdf  for GLJ’s price forecast.

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 news release are in United States dollars, except as otherwise noted.

Abbreviations:

1P=proved reserves
2P=proved plus probable reserves
3P=proved plus probable plus possible reserves
Mbbl=thousands of barrels
Mboe=thousand barrels of oil equivalent
MMbtu=million British Thermal Units
MMcf=million cubic feet
MMboe=million barrels of oil equivalent
$000s=thousands of U.S. dollars

Oil and Natural Gas Advisories

Oil and Natural Gas Reserves

The disclosure in this news release summarizes certain information contained in the GLJ Reserves and Resources Report but represents only a portion of the disclosure required under NI 51-101. Full disclosure with respect to the Company’s reserves as at December 31, 2023 will be included in the Company’s annual information form for the year ended December 31, 2023 which will be filed on SEDAR+ (www.sedarplus.ca) on or before April 30, 2024. The GLJ Reserves and Resources Report incorporates Alvopetro’s working interest share of remaining recoverable reserves and resources.  With respect to the Caburé natural gas field, Alvopetro’s working interest was 49.1% as of December 31, 2023 but is subject to redetermination, the first of which is currently underway. The outcome of this redetermination is unknown and the resulting impact on the reserves and the net presented value of future net revenue attributable to such reserves as presented herein may be material.

All net present values in this press release are based on estimates of future operating and capital costs and GLJ’s forecast prices as of December 31, 2023. The reserves definitions used in this evaluation are the standards defined by COGEH reserve definitions and are consistent with NI 51-101 and used by GLJ. The net present values of future net revenue attributable to the Alvopetro’s reserves estimated by GLJ do not represent the fair market value of those reserves. Other assumptions and qualifications relating to costs, prices for future production and other matters are summarized herein. The recovery and reserve estimates of the Company’s reserves provided herein are estimates only and there is no guarantee that the estimated reserves will be recovered. Actual reserves may be greater than or less than the estimates provided herein. Possible reserves are those additional reserves that are less certain to be recovered than probable reserves. There is a 10% probability that the quantities actually recovered will equal or exceed the sum of proved plus probable plus possible reserves.

Contingent Resources

This news release discloses estimates of Alvopetro’s contingent resources and the net present value associated with net revenues associated with the production of such contingent resources as included in the GLJ Reserves and Resources Report. There is no certainty that it will be commercially viable to produce any portion of such contingent resources and the estimated future net revenues do not necessarily represent the fair market value of such contingent resources. Estimates of contingent resources involve additional risks over estimates of reserves. Full disclosure with respect to the Company’s contingent resources as at December 31, 2023 will be contained in the Company’s annual information form for the year ended December 31, 2023 which will be filed on SEDAR+ (www.sedarplus.ca)  on or before April 30, 2024.

Prospective Resources

This news release discloses estimates of Alvopetro’s prospective resources included in the GLJ Reserves and Resources Report. There is no certainty that any portion of the prospective resources will be discovered and even if discovered, there is no certainty that it will be commercially viable to produce any portion. Estimates of prospective resources involve additional risks over estimates of reserves. The accuracy of any resources estimate is a function of the quality and quantity of available data and of engineering interpretation and judgment. While resources presented herein are considered reasonable, the estimates should be accepted with the understanding that reservoir performance subsequent to the date of the estimate may justify revision, either upward or downward. Full disclosure with respect to the Company’s prospective resources as at December 31, 2023 will be contained in the Company’s annual information form for the year ended December 31, 2023 which will be filed on SEDAR+ (www.sedarplus.ca) on or before April 30, 2024.

Boe Disclosure

The term barrels of oil equivalent (“boe”) may be misleading, particularly if used in isolation. A boe conversion ratio of six thousand cubic feet per barrel (6Mcf/bbl) of natural gas to barrels of oil equivalence is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. All boe conversions in this news release are derived from converting gas to oil in the ratio mix of six thousand cubic feet of gas to one barrel of oil.

Forward-Looking Statements and Cautionary Language

This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward‐looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning the redetermination and Alvopetro’s working interest share of the unitized area and the potential impact of the redetermination on Alvopetro, plans relating to the Company’s operational activities, proposed development activities and the timing for such activities, capital spending levels and future capital costs, the expected natural gas price, gas sales and gas deliveries under Alvopetro’s long-term gas sales agreement. The forward‐looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to expectations and assumptions concerning the timing of regulatory licenses and approvals, equipment availability, the success of future drilling, completion, testing, recompletion and development activities, the performance of producing wells and reservoirs, well development and operating performance, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, the outlook for commodity markets and ability to access capital markets, foreign exchange rates, general economic and business conditions, the impact of the COVID-19 pandemic, weather and access to drilling locations, the availability and cost of labour and services, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors. Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our annual information form which may be accessed on Alvopetro’s SEDAR+ profile at www.sedarplus.ca). 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 – CVG Announces Fourth Quarter and Full Year 2023 Earnings Call

Research News and Market Data on CVGI

February 23, 2024

NEW ALBANY, Ohio, Feb. 23, 2024 (GLOBE NEWSWIRE) — Commercial Vehicle Group (the “Company” or “CVG”) (NASDAQ: CVGI) will hold its quarterly conference call on Tuesday, March 5, 2024, at 10:00 a.m. ET, to discuss fourth quarter and full year 2023 financial results. CVG will issue a press release and presentation prior to the conference call.

Toll-free participants dial (888) 259-6580 using conference code 88986985. International participants dial (416) 764-8624 using conference code 88986985. This call is being webcast and can be accessed through the “Investors” section of CVG’s website at ir.cvgrp.com where it will be archived for one year.

A telephonic replay of the conference call will be available until March 19, 2024. To access the replay, toll-free callers can dial (877) 674-7070 using access code 986985.

About CVG

At CVG, we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.

Investor Relations Contact:
Ross Collins or Stephen Poe
Alpha IR Group
CVGI@alpha-ir.com

Source: Commercial Vehicle Group, Inc.

Release – Kratos Defense & Security Solutions, Inc. Prices Public Offering of Common Stock

Research News and Market Data on KTOS

February 22, 2024 at 7:45 PM EST

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SAN DIEGO, Feb. 22, 2024 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (“Kratos”) (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Global Markets, today announced the pricing of an underwritten offering of 16,666,667 shares of its common stock at a public offering price of $18.00 per share pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (the “SEC”). The net proceeds to Kratos from the offering, after deducting underwriting discounts and commissions, are expected to be approximately $288 million. Kratos has also granted the underwriters a 30-day option to purchase up to an additional 2,500,000 shares of common stock. All of the shares in the offering are to be sold by Kratos. The offering is expected to close on February 27, 2024, subject to customary closing conditions.

Kratos expects to use the net proceeds to facilitate its long-term strategy, including potential investment in facilities, expanding manufacturing capacity, anticipated capital expenditures for expansion of current sole-source/single award programs and high probability pipeline opportunities, further strengthen the Company’s balance sheet in anticipation of upcoming customer and partner decisions and source selection on additional large, new program and contract opportunities, for general corporate purposes, including paydown of debt, and to pay fees and expenses in connection with the offering.

Baird, RBC Capital Markets, and Truist Securities are acting as joint book-running managers for the offering. B. Riley Securities and Raymond James are acting as passive book-runners for the offering. The Benchmark Company and Noble Capital Markets are acting as co-managers for the offering.

The securities described above are being offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-277222) that was previously filed by Kratos with the SEC and automatically became effective upon filing on February 21, 2024. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

The offering will be made only by means of a prospectus supplement and the accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the offering have been filed with the SEC and a final prospectus supplement will be filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, from Robert W. Baird & Co. Incorporated, 777 E. Wisconsin Avenue, Milwaukee, Wisconsin 53202, by telephone at (800) 792-2473, or by email at syndicate@rwbaird.com, RBC Capital Markets, LLC, 200 Vesey Street, New York, New York 10281, by telephone at (877) 822-4089, or by email at equityprospectus@rbccm.com, Truist Securities, Inc., 3333 Peachtree Road NE, 9th Floor, Atlanta, Georgia 30326, by telephone at (800) 685-4786, or by email at TruistSecurities.prospectus@Truist.com, B. Riley Securities, Inc., 1300 17th Street North, Suite 1300, Arlington, VA 22209, by telephone at (703) 312-9580, or by email at prospectuses@brileyfin.com, Raymond James & Associates, Inc., 880 Carillon Parkway, St. Petersburg, FL 33716, by telephone at (800) 248-8863, or by email at prospectus@raymondjames.com, The Benchmark Company, LLC, 150 East 58th St., 17th Floor, New York, NY 10155, by telephone at (212) 312-6700, or by email at Prospectus@benchmarkcompany.com and Noble Capital Markets, Inc., 150 East Palmetto Park Rd., Suite 110, Boca Raton, FL 33432, by telephone at (561) 998-5483, or by email at jtarantino@noblecapitalmarkets.com. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the SEC’s website at www.sec.gov.

About Kratos Defense & Security Solutions

Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value-add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos comfort level. Kratos primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements relate to a variety of matters, including, without limitation, Kratos’ expectations regarding the sale of shares of its common stock in the proposed public offering, use of the expected proceeds from the proposed public offering and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements including, but not limited to: risks and uncertainties related to market conditions, the satisfaction of customary closing conditions related to the proposed public offering, and general economic factors. There can be no assurance that Kratos will be able to complete the proposed public offering on the anticipated terms, or at all. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 31, 2023, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Yolanda White
858-812-7302 Direct

Investor Information:
877-934-4687
investor@kratosdefense.com

Source: Kratos Defense & Security Solutions, Inc.

Release – Ocugen, Inc. Announces Dosing Completion Of Subjects With Stargardt In Cohort 1 Of Phase 1/2 Clinical Trial Evaluating The Safety And Efficacy Of OCU410ST

Research News and Market Data on OCGN

February 22, 2024

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MALVERN, Pa., Feb. 22, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the first cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease. Stargardt disease is an orphan blindness disease that affects approximately 35,000 people in the United States alone.

“This is an important clinical milestone for our first-in-class, potential one-time therapy for the treatment of Stargardt disease,” said Dr. Arun Upadhyay, Chief Scientific Officer and Head of R&D at Ocugen. “Although Stargardt is one of the most common inherited retinal diseases, there remains no treatment option to address this condition. OCU410ST provides hope to these patients who may eventually lose their vision.”

Up to 10 leading retinal surgery centers across the United States are participating in the GARDian clinical trial. In the first cohort, 3 subjects received 200L single subretinal administration of the low dose (3.75×1010 vg/mL) of OCU410ST.

“I am very pleased to participate in this study and to offer a novel modifier gene therapy option to my patients,” said Benjamin Bakall, MD, PhD, Director of Clinical Research at Associated Retina Consultants and Clinical Assistant Professor at the University of Arizona, College of Medicine—Phoenix. “Until now, we have not had any effective treatment that can prevent the vision loss in patients with Stargardt disease. Now, I believe that this approach can offer a new therapeutic option to address the disease itself.”

The GARDian clinical trial will assess the safety of unilateral subretinal administration of OCU410ST in subjects with Stargardt disease and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose ranging study consisting of three dose levels [low dose (3.75×10E10 vg/mL), medium dose (7.5×10E10 vg/mL), and high dose (2.25×10E11 vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which adult and pediatric subjects will be randomized in a 1:1:1 ratio to either one of two OCU410ST dose groups or to an untreated. The Company will continue to provide clinical updates.

About Stargardt Disease

Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

About OCU410ST

OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathway links to Stargardt disease such as lipofuscin formation, oxidative stress, compliment formation, inflammation, and cell survival networks.

About Ocugen, Inc.

Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, 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 X and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release. 

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

Release – ACCO Brands Reports Fourth Quarter and Full Year 2023 Results and Provides Outlook for 2024

Research News and Market Data on ACCO

02/22/2024

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Company Exceeds Full Year 2023 Outlook

Full Year

  • Reported net sales of $1.833 billion, with gross margin expanding 420 basis points
  • Operating income of $45 million; adjusted operating income grew 17% to $205 million
  • Loss per share of $(0.23); adjusted EPS of $1.09, above the Company’s outlook
  • Net operating cash flow improved $51 million, generated adjusted free cash flow of $118 million
  • Reduced total debt by $88 million with a consolidated net leverage ratio of 3.4x at year-end

LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today reported financial results for the fourth quarter and fiscal year ended December 31, 2023.

“I am pleased to report that our fourth quarter financial performance, including our reported net sales and adjusted EPS and free cash flow, was better than expected. During the year, we successfully executed against our 2023 priorities and implemented our previously announced restructuring plans, which enabled us to significantly expand our gross margin, deliver strong free cash flow, and reduce our consolidated net leverage ratio to 3.4x at the end of 2023. We believe our achievement of these results against a challenging demand environment is a testament to the solid execution of our team and our geographically diverse portfolio of leading brands. The restoration of our gross margins and improved cash flows enables us to make investments that position the Company for long-term growth,” stated ACCO Brands’ President and Chief Executive Officer, Tom Tedford.

Fourth Quarter Results

Net sales declined 2.2 percent to $488.6 million from $499.4 million in 2022. Comparable sales fell 4.6 percent, as favorable foreign exchange increased sales by $12.2 million, or 2.4 percent. Both reported and comparable sales declines reflect softer demand due to a weaker macroeconomic environment, which has also led to lower global demand for our technology accessories. These factors more than offset growth in our International segment, driven by the recovery of back-to-school sales in Latin America.

Operating loss was $52.8 million versus operating income of $35.6 million in 2022, primarily due to a non-cash goodwill impairment charge of $89.5 million related to the North America segment. In 2023, we recognized restructuring charges of $20.9 million, compared to $7.3 million in the prior-year period, with the increase related to our continuing footprint rationalization and cost reduction programs. Adjusted operating income increased 30.6 percent to $68.3 million from $52.3 million in the prior-year period. This increase reflects recovery of gross margin from the effect of cumulative global price increases and cost reduction actions, as well as moderating input costs. This was partially offset by higher SG&A expense, primarily due to an increase in incentive compensation compared to the prior year.

The Company reported a net loss of $59.4 million, or $(0.62) per share, compared with prior-year net income of $18.8 million, or $0.20 per share. The net loss is primarily due to the non-cash goodwill impairment charge of $89.5 million, with no associated tax benefit, as well as the higher restructuring charges noted above. In addition, there was a favorable change in discrete tax items of $21.8 million, largely related to recent tax legislation in both Brazil and the United States. Adjusted net income was $37.5 million, or $0.39 per share, compared with $30.5 million, or $0.32 per share in 2022. The increase in adjusted net income was due to the items noted above in adjusted operating income, partially offset by higher interest and non-operating pension expenses.

Full Year Results

Net sales decreased 5.9 percent to $1.83 billion from $1.95 billion in 2022. Favorable foreign exchange increased sales by $11.3 million, or 0.6 percent. Comparable sales decreased 6.5 percent. Both reported and comparable sales declines reflect the challenging macroeconomic environment, especially in North America and EMEA, and lower than anticipated return to office trends, as well as tight inventory management by our customers in North America. Sales of technology accessories were most negatively impacted. This more than offset the benefit of cumulative price increases across all segments, and volume growth in Latin America.

Operating income was $44.7 million compared to $34.8 million in 2022. The increase in operating income is primarily due to a lower non-cash goodwill impairment charge of $89.5 million versus the $98.7 million recorded in 2022. In 2023, we recorded restructuring charges of $27.2 million compared to $9.6 million in 2022, with the increase related to our continuing footprint rationalization and cost reduction programs. 2022 includes a benefit related to the change in value of the PowerA contingent earnout of $9.0 million, which did not repeat in 2023. Adjusted operating income increased to $204.8 million from $175.8 million in 2022. Both reported and adjusted operating income increases reflect the benefit of cumulative global price increases and cost reduction initiatives, partially offset by negative fixed cost leverage and higher SG&A expense, primarily due to increased incentive compensation.

Net loss was $21.8 million, or $(0.23) per share, compared with a net loss of $13.2 million, or $(0.14) per share, in 2022. The net losses were primarily related to the items noted above in operating income. In 2023, there was a significant increase in discrete tax benefits largely related to recent tax legislation in both Brazil and the United States, partially offset by reduced operating tax gains. Adjusted net income was $105.6 million compared with $101.0 million in 2022, and adjusted earnings per share were $1.09 per share compared with $1.04 per share in 2022. The increase in adjusted net income was due to the items noted above in adjusted operating income, partially offset by higher interest and non-operating pension expenses.

Capital Allocation and Dividend

For the full year, the Company significantly improved its operating cash flow to $128.7 million versus $77.6 million in the prior year, driven primarily by improved profits and working capital. Adjusted free cash flow in 2023 improved by $40.0 million to $117.5 million versus $77.5 million in 2022. Adjusted free cash flow in 2022 excludes the contingent earnout payment. The Company’s consolidated leverage ratio as of December 31, 2023 was 3.4x.

On February 16, 2024, ACCO Brands announced that its board of directors declared a regular quarterly cash dividend of $0.075 per share. The dividend will be paid on March 27, 2024 to stockholders of record at the close of business on March 15, 2024.

Restructuring and Cost Savings Program

On January 30, 2024, the Company announced a multi-year restructuring and cost savings program, with anticipated annualized pre-tax cost savings of at least $60 million. The program incorporates initiatives to simplify and delayer the Company’s operating structure and reduce costs through headcount reductions, supply chain optimization, global footprint rationalization, and better leveraging the Company’s sourcing capabilities. As a result of these actions, the Company will improve its speed of execution and bring key leaders closer to customers.

In connection with the program, the Company recognized pre-tax restructuring charges of $20.9 million in the fourth quarter of 2023, related to costs associated with the headcount reductions, as well as the closing of its Sidney, NY manufacturing facility. This was the fourth facility closure announced in 2023.

New Operating Segments

As previously announced, the Company will be implementing a new operating model, consolidating its three reportable segments into two reportable segments. The Americas reporting segment will include the U.S., Canada, Brazil, Mexico and Chile and the International reporting segment will include EMEA, Australia, New Zealand, and Asia. The Company will report on this basis for the fiscal year commencing January 1, 2024.

Business Segment Results

ACCO Brands North America – For the full year, North America net sales of $887.2 million decreased 11.1 percent from $998.0 million in 2022, and comparable sales declined 10.7 percent. Fourth quarter segment net sales of $199.0 million and comparable sales of $199.1 million both decreased 11.8 percent versus the prior year. Both full-year and fourth quarter reported and comparable sales decreases reflect softer demand due to a weaker macroeconomic environment, lower than anticipated return to office trends and retailers maintaining lower inventory levels, which resulted in lower demand for technology accessories and office products. This more than offset the benefit of cumulative pricing actions.

In North America, full year operating loss was $5.9 million versus an operating loss of $4.9 million in 2022. In 2023, we recorded a $89.5 million non-cash goodwill impairment charge compared to the $98.7 million recorded in the prior year. In 2023, restructuring charges were $16.7 million, an increase from the $5.3 million in 2022, largely related to our cost reduction and productivity programs. Adjusted operating income was $122.4 million, up from $121.5 million in the prior year, as benefits of the cumulative effect of pricing and cost actions, were largely offset by lower volume and negative fixed cost leverage.

ACCO Brands EMEA – Full year net sales in the EMEA segment of $547.2 million decreased 5.7 percent from $580.3 million in 2022. Favorable foreign exchange increased sales by 1.0 percent. Comparable sales declined 6.7 percent. Fourth quarter segment net sales of $159.1 million increased 2.0 percent versus the prior year’s net sales of $156.0 million. Favorable foreign exchange increased sales by 4.6 percent for the quarter. Comparable sales of $152.0 million decreased 2.6 percent versus the prior-year period as volume declines moderated sequentially in the quarter. Both full year and fourth quarter comparable sales declines reflect reduced demand, especially for technology accessories, due to a weaker macroeconomic environment. This more than offset the benefit of cumulative pricing actions.

The EMEA segment posted full-year operating income of $38.7 million compared with operating income of $21.7 million in 2022. In 2023, we recorded restructuring charges of $8.9 million versus $3.4 million in 2022, with the increase related to our ongoing footprint rationalization and cost reduction programs. Adjusted operating income was $62.5 million, up from $37.0 million in 2022. The increases in both reported operating income and adjusted operating income reflect recovery of gross margins from price increases and cost savings actions, more than offsetting negative fixed cost leverage and higher incentive compensation.

ACCO Brands International – International segment net sales of $398.4 million for the full year increased 7.9 percent from $369.3 million in 2022. Favorable foreign exchange increased sales by 2.6 percent. Comparable sales were $388.7 million, up 5.3 percent versus the prior year. Fourth quarter segment net sales of $130.5 million increased 10.9 percent versus the prior year’s net sales of $117.7 million. Favorable foreign exchange increased sales by 4.4 percent for the quarter. Comparable sales were $125.3 million an increase of 6.5 percent versus the year-ago period. Both full year and fourth quarter reported and comparable sales increases reflect stronger pricing and volume growth in Latin America, more than offsetting the impact of weaker economic conditions in Australia and Asia and overall lower demand for technology accessories.

Operating income for the full year was $60.7 million, an increase from $50.5 million in 2022. Adjusted operating income of $68.1 million increased from $58.3 million in the prior year. The increase in both operating and adjusted operating income were primarily due to the cumulative benefit of pricing and cost actions, somewhat offset by higher go-to-market spending, people costs and incentive compensation.

2024 Outlook

“We are taking actions to reposition the company for long-term, sustainable, profitable growth. In January, we announced a multi-year restructuring and cost savings program, to reset our cost structure. The program is expected to deliver at least $60 million in annual cost savings once fully implemented and will better leverage our global platform and leading brands. We continue to focus on our margin profile by exiting low margin business and better leveraging our sourcing and supply chain infrastructure. These actions will enable us to accelerate investments in new product development, innovation, and other growth initiatives, while increasing our profitability and cash flow, leading to improved shareholder value,” concluded Mr. Tedford.

For the full year, we expect reported sales to be down in the range of 2.0% to 5.0%. The Company’s sales outlook reflects the uncertain demand environment for its categories. Full year adjusted EPS is expected to be within a range of $1.07 to $1.11. The Company expects 2024 free cash flow to grow to at least $120 million and to end the year with a consolidated leverage ratio of approximately 3.0x to 3.2x.

In the first quarter, we expect reported sales to be down in the range of 6.5% to 8.0% and adjusted EPS within a range of $0.01 to $0.04. Seasonally, sales can shift between first and second quarter due to the timing of back-to-school shipments in North America.

Webcast

At 8:30 a.m. ET on February 23, 2024, ACCO Brands Corporation will host a conference call to discuss the Company’s fourth quarter and full year 2023 results. The call will be broadcast live via webcast. The webcast can be accessed through the Investor Relations section of www.accobrands.com . The webcast will be in listen-only mode and will be available for replay following the event.

About ACCO Brands Corporation

ACCO Brands, the Home of Great Brands Built by Great People, designs, manufactures and markets consumer and end-user products that help people work, learn, and play. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com .

Non-GAAP Financial Measures

In addition to financial results reported in accordance with generally accepted accounting principles (GAAP), we have provided certain non-GAAP financial information in this earnings release to aid investors in understanding the Company’s performance. Each non-GAAP financial measure is defined and reconciled to its most directly comparable GAAP financial measure in the “About Non-GAAP Financial Measures” section of this earnings release.

Forward-Looking Statements

Statements contained herein, other than statements of historical fact, particularly those anticipating future financial performance, business prospects, growth, strategies, business operations and similar matters, results of operations, liquidity and financial condition, and those relating to cost reductions and anticipated pre-tax savings and restructuring costs are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on the beliefs and assumptions of management based on information available to us at the time such statements are made. These statements, which are generally identifiable by the use of the words “will,” “believe,” “expect,” “intend,” “anticipate,” “estimate,” “forecast,” “project,” “plan,” and similar expressions, are subject to certain risks and uncertainties, are made as of the date hereof, and we undertake no duty or obligation to update them. Forward-looking statements are subject to the occurrence of events outside the Company’s control and actual results and the timing of events may differ materially from those suggested or implied by such forward-looking statements due to numerous factors that involve substantial known and unknown risks and uncertainties. Investors and others are cautioned not to place undue reliance on forward-looking statements when deciding whether to buy, sell or hold the Company’s securities.

Our outlook is based on certain assumptions, which we believe to be reasonable under the circumstances. These include, without limitation, assumptions regarding the impact of inflation and global geopolitical and economic uncertainties and fluctuations in foreign currency exchange rates; and the other factors described below.

Among the factors that could cause our actual results to differ materially from our forward-looking statements are: our ability to successfully execute our restructuring and cost savings plans and realize the anticipated benefits of these plans and our other ongoing productivity initiatives; our ability to obtain additional price increases and realize longer-term cost reductions; the ongoing impact of the COVID-19 pandemic; a relatively limited number of large customers account for a significant percentage of our sales; issues that influence customer and consumer discretionary spending during periods of economic uncertainty or weakness; risks associated with foreign currency exchange rate fluctuations; challenges related to the highly competitive business environment in which we operate; our ability to develop and market innovative products that meet consumer demands and to expand into new and adjacent product categories that are experiencing higher growth rates; our ability to successfully expand our business in emerging markets and the exposure to greater financial, operational, regulatory, compliance and other risks in such markets; the continued decline in the use of certain of our products; risks associated with seasonality; the sufficiency of investment returns on pension assets, risks related to actuarial assumptions, changes in government regulations and changes in the unfunded liabilities of a multi-employer pension plan; any impairment of our intangible assets; our ability to secure, protect and maintain our intellectual property rights, and our ability to license rights from major gaming console makers and video game publishers to support our gaming accessories business; continued disruptions in the global supply chain; risks associated with inflation and other changes in the cost or availability of raw materials, transportation, labor, and other necessary supplies and services and the cost of finished goods; risks associated with outsourcing production of certain of our products, information technology systems and other administrative functions; the failure, inadequacy or interruption of our information technology systems or its supporting infrastructure; risks associated with a cybersecurity incident or information security breach, including that related to a disclosure of personally identifiable information; our ability to grow profitably through acquisitions; our ability to successfully integrate acquisitions and achieve the financial and other results anticipated at the time of acquisition, including planned synergies; risks associated with our indebtedness, including limitations imposed by restrictive covenants, our debt service obligations, and our ability to comply with financial ratios and tests; a change in or discontinuance of our stock repurchase program or the payment of dividends; product liability claims, recalls or regulatory actions; the impact of litigation or other legal proceedings; our failure to comply with applicable laws, rules and regulations and self-regulatory requirements, the costs of compliance and the impact of changes in such laws; our ability to attract and retain qualified personnel; the volatility of our stock price; risks associated with circumstances outside our control, including those caused by public health crises, such as the occurrence of contagious diseases, severe weather events, war, terrorism and other geopolitical incidents; and other risks and uncertainties described in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, and in other reports we file with the Securities and Exchange Commission.

Click to read the the full release: ACCO Brands Reports Fourth Quarter and Full Year 2023 Results and Provides Outlook for 2024

Christopher McGinnis

Investor Relations

(847) 796-4320

Kori Reed

Media Relations

(224) 501-0406

Source: ACCO Brands Corporation

Release – MAIA Biotechnology Completes Enrollment In THIO-101 Phase 2 Clinical Trial for Non-Small Cell Lung Cancer 

Research News and Market Data on MAIA

February 22, 2024 10:30am EST

  • Topline data expected in second half of 2024
  • THIO-101 will be the first completed clinical study of a telomere targeting agent in the field of cancer drug discovery and treatment

CHICAGO, IL, Feb. 22, 2024 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that enrollment is now complete in its Phase 2 THIO-101 go-to-market clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC).

The trial reached the enrollment target of 41 patients for the 180mg/dose on February 19, 2024. As of the latest data available for the trial, 79 patients had received either 60mg (24 patients), 180mg (41 patients) or 360mg (14 patients). The original trial design targeted up to 182 patients, including all patients in the safety lead-in and 41 patients in each of the 3 tested doses (60mg, 180mg, and 360mg). Following the selection of 180 mg/cycle as the optimal dose in December 2023, all patients were subsequently enrolled at the 180mg/cycle dose and trial enrollment was completed ahead of schedule.

“Enrollment in our Phase 2 THIO-101 trial has been strong from the start. With excellent results across all doses and our selection of the optimal dose in December 2023, we enrolled the necessary number of patients in the Simon 2-stage design to achieve our trial endpoints earlier than expected,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “THIO-101 preliminary data has demonstrated unprecedented rates of disease control and response to date, and we look forward to the long-term efficacy results as we continue to monitor the enrolled patients in the upcoming months. As the only direct telomere targeting agent currently undergoing clinical development in the field of cancer, we believe THIO holds a time-to-market advantage and strong potential to become a new standard of care for NSCLC.”

The main objectives of the THIO-101 trial are to evaluate the safety, tolerability, and preliminary clinical efficacy of THIO in patients with advanced NSCLC who have experienced disease progression or relapse after initial treatments with an immune CPI alone or in combination with chemotherapy.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact

+1 (872) 270-3518
ir@maiabiotech.com

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Source: MAIA Biotechnology, Inc.

Released February 22, 2024

Release – GeoVax to Report 2023 Financial Results and Provide Corporate Update on February 29, 2024

Research News and Market Data on GOVX

GeoVax to Host Conference Call at 4:30 PM ET

Atlanta, GA, February 22, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report 2023 financial results on Thursday, February 29, 2024, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

Dial-in numbers:

Domestic:          (800) 715-9871

International:    +1 (646) 307-1963

Conference ID:  3926207

Webcast:

A webcast of the live call may be accessed here and on the Events page of the GeoVax website. A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation Covid-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized Covid-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable Covid-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Company Contact:                  Investor Relations Contact:                  Media Contact:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com 
678-384-7220 212-698-8699 202-779-0929

Release – Harte Hanks to Report Fourth Quarter and Full Year 2023 Financial Results on March 14, 2024

Research News and Market Data on HHS

Thursday, 22 February 2024 08:00 AM

CHELMSFORD, MA / ACCESSWIRE / February 22, 2024 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company focused on bringing companies closer to customers for over 100 years, announced today that the company will release financial results for the fourth quarter and full year 2023 period ended December 31, 2023 on Thursday, March 14, 2024 after the close of the market.

The Company will host a conference call and live webcast to discuss these results at 4:30 p.m. EST on the same day. Interested parties may access the webcast at https://www.webcaster4.com/Webcast/Page/2810/49883or may access the conference call by dialing 888-506-0062 in the United States or 973-528-0011 from outside the U.S. and using access code 692780.

A replay of the call can also be accessed via phone through March 28, 2024 by dialing (877) 481-4010 from the U.S., or (919) 882-2331 from outside the U.S. The conference call replay passcode is 49883.

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:

Rob Fink or Tom Baumann
646.809.4048 / 646.349.6641
FNK IR
HHS@fnkir.com

SOURCE: Harte Hanks, Inc.

Release – GoHealth to Announce Fourth Quarter and Year End 2023 Results on March 14, 2024

Research News and Market Data on GOCO

Feb 22, 2024 at 8:00 AM EST

CHICAGO, Feb. 22, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (GoHealth) (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, announced that the company will release its fourth quarter and full year 2023 financial results on the morning of March 14, 2024.

Chief Executive Officer, Vijay Kotte, and Chief Financial Officer, Jason Schulz, will host a conference call and live audio webcast on the day of the release at 8:00 a.m. (ET) to discuss the results.

A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company. Enrolling in a health insurance plan can be confusing for customers, and the seemingly small differences between plans can lead to significant out-of-pocket costs or lack of access to critical medicines and even providers. GoHealth combines cutting-edge technology, data science and deep industry expertise to match customers with the healthcare policy and carrier that is right for them. Since its inception, GoHealth has enrolled millions of people in Medicare plans and individual and family plans. For more information, visit https://www.gohealth.com.

Investor Relations
John Shave
jshave@gohealth.com

Media Relations
Pressinquiries@gohealth.com

Release – ZyVersa Therapeutics Publishes New White Paper Detailing the Role of Inflammasomes and ASC Specks in Neurological Diseases, and Data Supporting Inflammasome ASC Inhibitor IC 100 as a Potential Therapeutic Option

Research News and Market Data on ZVSA

Feb 22, 2024

PDF Version

  • Neurological diseases, which affect up to 16 million people over 18 years old in the US, are the leading cause of physical and cognitive disability.
  • A growing body of evidence supports that activation of more than one type of inflammasome contributes to development of common neurological diseases, and that extracellular ASC specks are involved in disease progression.
  • The white paper summarizes the preclinical research of leading inflammasome experts, Drs. Robert W. Keane and Juan Pablo de Rivero Vaccari at University of Miami Miller School of Medicine, demonstrating that Inflammasome ASC Inhibitor IC 100 crosses the blood brain barrier, and that it displays strong pharmacologic and mechanistic proof-of-concept in a variety of neurological conditions.

WESTON, Fla., Feb. 22, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with inflammatory and renal diseases who have significant unmet medical needs, announces availability of a new white paper titled, “Inflammasome ASC Inhibitor IC 100, Promising Therapeutic Potential For Neurological Diseases.” The white paper highlights data demonstrating that activation of more than one type of inflammasome and associated release of ASC specks leads to development and progression of common neurological diseases. The white paper then summarizes data from preclinical research led by Drs. Robert W. Keane and Juan Pablo de Rivero Vaccari at the University of Miami Miller School of Medicine demonstrating strong pharmacologic and mechanistic proof-of-concept for Inflammasome ASC Inhibitor IC 100 in animal models and tissue cultures representative of a variety of neurological conditions: multiple sclerosis, age-related inflammation, Alzheimer’s disease, traumatic brain injury, and spinal cord injury. Drs. Keane, de Rivero Vaccari, and their colleagues currently have research underway in Parkinson’s disease that was funded through a grant with the Michael J. Fox Foundation. To access a copy of the white paper, Click Here.

“We are excited about the potential of targeting multiple inflammasome pathways and ASC specks with Inflammasome ASC Inhibitor I00 to control the damaging inflammation contributing to neurological diseases that negatively impact the quality of life in millions of people,” said Stephen C. Glover, Co-founder, Chairman, CEO, and President of ZyVersa. “We are nearing completion of our preclinical program for IC 100 and expect to file an IND in the fourth quarter of 2024, with plans to initiate a phase 1 clinical trial in early 2025.”

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 attenuates both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business 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. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:

Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641