Validated science-based targets emphasize The ODP Corporation’s commitment to environmental sustainability
BOCA RATON, Fla.–(BUSINESS WIRE)–Nov. 16, 2023– The ODP Corporation is proud to announce that it has successfully earned validation from the Science Based Targets initiative (SBTi) of its science-based targets for scope 1, scope 2, and scope 3 greenhouse gas (GHG) emissions. This significant milestone demonstrates The ODP Corporation’s commitment to environmental sustainability and aligns with its ongoing efforts to combat the effects of climate change.
The science-based targets reflect The ODP Corporation’s goals for reducing GHG emissions, including a commitment to reduce absolute scope 1 and 2 GHG emissions 46.2% by 2030 from a 2019 base year. The Company further commits to reduce scope 3 GHG emissions from downstream transportation and distribution and use of sold products 55% per USD value added by 2030 from a 2019 base year.
As part of its dedication to driving sustainability throughout its supply chain, The ODP Corporation also commits that 75% of its suppliers by spend covering purchased goods and services will have science-based targets by 2027. This collaborative effort will contribute to reducing emissions and fostering an environmentally responsible business ecosystem.
“We are incredibly proud to have our science-based targets validated, as it underscores our commitment to make meaningful changes in our environmental impact,” said Shannon Hunter, vice president of sustainability at The ODP Corporation. “By setting these targets, we are sending a clear message to all of our stakeholders—including our employees, customers, and partners—that we are dedicated to environmental sustainability and actively reducing our carbon footprint.”
Achieving validation of our science-based targets is a testament to The ODP Corporation’s ongoing sustainability journey. The ODP Corporation remains committed to continuously improving its environmental practices and embracing innovative solutions. This announcement marks a pivotal step forward in the company’s sustainability efforts and reinforces its position as a responsible corporate citizen.
The ODP Corporation (NASDAQ:ODP) is a leading provider of products, services, and technology solutions through an integrated business-to-business (B2B) distribution platform and omnichannel presence, which includes world-class supply chain and distribution operations, dedicated sales professionals, a B2B digital procurement solution, online presence and a network of Office Depot and OfficeMax retail stores. Through its operating companies Office Depot, LLC; ODP Business Solutions, LLC; Veyer, LLC; and Varis, Inc., The ODP Corporation empowers every business, professional, and consumer to achieve more every day. For more information, visit theodpcorp.com.
ODP and ODP Business Solutions are trademarks of ODP Business Solutions, LLC. Office Depot is a trademark of The Office Club, LLC. OfficeMax is a trademark of OMX, Inc. Veyer is a trademark of Veyer, LLC. Varis is a trademark of Varis, Inc. Any other product or company names mentioned herein are the trademarks of their respective owners.
Annual awards honor technology and business service providers that deliver the highest level of customer service to enterprise clients
LONDON–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, last night presented the 2023 ISG Star of Excellence Awards™ to Accenture, HCLTech and TCS, recognizing the three service providers for consistently demonstrating the highest standards of customer service excellence in the past year, based on direct feedback from enterprise customers.
In a ceremony at the ISG Sourcing Industry Awards Gala Dinner, held at the conclusion of the ISG Sourcing Industry Conference at the Park Plaza Victoria London, the providers were awarded the sixth annual overall ISG Star of Excellence Awards for earning the highest cumulative customer experience scores across all regions, industries and technology areas.
The ISG Star of Excellence Awards, part of the ISG Provider Lens™ research program, is the premiere industry recognition for the technology and business services industry. Providers are ranked on the quality of their services based on direct feedback from enterprise customers in the areas of Business Continuity and Flexibility; Collaboration and Transparency; Execution and Delivery; Governance and Compliance; Innovation and Thought Leadership, and People and Cultural Fit.
The winners are chosen from among a group of more than 2,000 service providers and vendors ISG analyzes and evaluates each year. This year, ISG received feedback from enterprise clients with roles in IT, operations, lines of business, procurement and vendor management and other areas, and operating in the Americas, EMEA and Asia Pacific.
In addition to the overall ISG Star of Excellence Award winners, last night’s ceremony recognized:
The top provider for each emerging technology area, with Hexaware named the universal winner for emerging technology;
The top provider for the Americas (Microland), EMEA (Stefanini) and Asia Pacific (TCS), with Genpact receiving the Global Award;
The top provider for each industry, with Persistent Systems named the universal industry winner;
The top ITO provider for each technology area, with HCLTech named ITO universal technology winner;
The top BPO provider by service area, with HCLTech named the universal BPO winner.
HCLTech was presented with a total of six awards across all categories, TCS a total of four awards and Persistent Systems a total of four awards. A complete list of winners can be found here.
Paul Gottsegen, president of ISG Research and Client Experience, noted the importance of customer feedback to the continued advancement of the entire industry.
“In 2023, more enterprises than ever shared their provider experiences through the ISG Star of Excellence program. This valuable feedback helps providers see themselves through the eyes of their customers and deepens ISG’s understanding of providers to support our research and sourcing advisory services,” said Gottsegen. “We are pleased to see the CX scores of providers are rising, even as clients’ expectations are increasing, especially around innovation and thought leadership.”
The ISG Star of Excellence™ CX research program scores and ranks providers based on customer survey responses. Ongoing surveys ask enterprises to rate their experiences with hundreds of IT and business services providers across industries, regions and technologies. The research goes beyond general satisfaction to explore, in depth, customer experiences with specific services and solutions offered by providers—research that is tied directly to ISG Provider Lens™ quadrant evaluations.
For more information on the ISG Star of Excellence™ continuous CX research program, visit this webpage. Service providers can nominate their customers to be a part of the program at any time throughout the year.
About ISG Provider Lens™ Research
The ISG Provider Lens™ Quadrant research series is the only service provider evaluation of its kind to combine empirical, data-driven research and market analysis with the real-world experience and observations of ISG’s global advisory team. Enterprises will find a wealth of detailed data and market analysis to help guide their selection of appropriate sourcing partners, while ISG advisors use the reports to validate their own market knowledge and make recommendations to ISG’s enterprise clients. The research currently covers providers offering their services globally, across Europe, as well as in the U.S., Canada, Brazil, the U.K., France, Benelux, Germany, Switzerland, the Nordics, Australia and Singapore/Malaysia, with additional markets to be added in the future. For more information about ISG Provider Lens research, please visit this webpage.
A companion research series, the ISG Provider Lens Archetype reports, offer a first-of-its-kind evaluation of providers from the perspective of specific buyer types.
About ISG
ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.
Conference call scheduled for 5:00 p.m. ET on November 20, 2023
NEW YORK, Nov. 15, 2023 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), a media and consumer products company with billions of dollars in retail sales generated by its brands through social commerce and live-stream shopping, today announced that it will report its third quarter 2023 financial results on November 20, 2023. The Company will hold a conference call with the investment community on November 20, 2023, at 5:00 p.m. ET.
Interested parties unable to access the conference call via the webcast may dial 800-715-9871 or 646-307-1963 and use the Conference ID 8167522. A replay of the webcast will be available on Xcel’s website.
About Xcel Brands Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, production, marketing, livestreaming, wholesale distribution and direct-to-consumer sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment and social media as one thing. Xcel owns the Judith Ripka, Halston, LOGO by Lori Goldstein, and C. Wonder brands and a minority stake in the Isaac Mizrahi brand. It also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing LLC. Xcel is pioneering a true omni-channel sales strategy that includes the promotion and sale of products under its brands through interactive television, digital livestream shopping, social commerce, brick-and-mortar retail and e-commerce channels. The company’s brands have generated in excess of $4 billion in retail sales via livestreaming in interactive television and digital channels alone.
Headquartered in New York City, Xcel Brands is led by an executive team with significant livestreaming, production, merchandising, design, marketing, retailing and licensing experience and has a proven track record of success in elevating branded consumer products companies. With an experienced team of professionals focused on design, production and digital marketing, Xcel maintains control of product quality and promotion across all of its product categories and distribution channels. Xcel differentiates by design. www.xcelbrands.com
For further information please contact: Andrew Berger SM Berger & Company 216-464-6400 andrew@smberger.com
Total revenue was €41.1 mm in Q3 2023, while net gaming revenue1 was €43.2 mm in the period, 42% and 41% above those from Q3 2022, respectively.
Mexico revenue was €18.8 mm in Q3 2023, while net gaming revenue1 was €21.0 mm in the period, 63% above Q3 2022.
Spain revenue (and net gaming revenue) reached €18.9 mm in Q3 2023, 27% above Q3 2022.
Net loss was €1.8 mm in Q3 2023 versus a net loss of €11.6 mm in Q3 2022.
Total cash position of €43 mm as of September 30, 2023.
Increasing full year 2023 net gaming revenue and Adj. EBITDA outlook to €155-165 mm and negative €10-18 mm, respectively, and reiterating plan to be Adj. EBITDA and cash flow positive for the full year in 2024.
Madrid, Spain and Tel Aviv, Israel, November 15, 2023 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, “the Company”), a leading online gaming operator in Spain and Latin America, has released its financial results for the third quarter and nine month period ended September 30, 2023.
Below are the main financial and operating metrics of the period.
Quarter ended September 30
Nine Months ended September 30
2022
2023
Chg. %
2022
2023
Chg. %
Net Gaming Revenue (EUR mm)1
Spain
14.9
18.9
27%
42.2
54.9
30%
Mexico
12.9
21.0
63%
34.8
56.6
63%
Colombia
1.9
1.8
(5%)
5.6
6.2
11%
Other
0.9
1.5
67%
2.7
4.1
52%
Total
30.6
43.2
41%
85.2
121.8
43%
Avg. Monthly Active Players (000s)2
Spain
35.2
41.0
16%
37.1
40.6
10%
Mexico
37.4
51.8
39%
34.3
50.3
46%
Colombia
24.2
22.7
(6%)
25.4
24.7
(3%)
Other
7.5
9.0
20%
6.8
9.1
34%
Total
104.3
124.5
19%
103.6
124.7
20%
Aviv Sher, CEO of Codere Online, stated, “We’re very pleased with our performance in the third quarter and to be presenting another set of impressive results. This quarter we not only posted significant net gaming revenue growth of 41% to €43 million, but also took a significant step in our path to profitability with break even Adjusted EBITDA in the period. It was a solid quarter for sports betting, with the return of the major sporting events, but also for our casino product, which contributed 58% of our revenue in the period.”
Mr. Sher further added, “Mexico continued to exceed our expectations with revenue growth of 63% in the third quarter, reaching €21.0 million and consolidating its position as our largest market (by revenue) ahead of Spain, where net gaming revenue also grew by an impressive 27%, to €18.9 million.”
Oscar Iglesias, CFO of Codere Online, stated, “Our third quarter results have shown that the combination of a strong brand, high-quality customer acquisitions and an attractive product offering has allowed us to deliver not only strong top line growth but also a significant improvement in profitability, with our first quarter of breakeven Adjusted EBITDA less than two years following our U.S. listing.”
Mr. Iglesias further added, “Based on these strong results and recent trading activity, we now expect to generate between €155-165 million of net gaming revenue and negative €10-18 million in Adjusted EBITDA in 2023, and reaffirm that we expect to generate positive Adjusted EBITDA and cash flow for the full year in 2024.”
Conference Call Information
Codere Online’s management will host a conference call to discuss the results and provide a business update at 8:30 am US Eastern Time today, November 15, 2023. Dial-in details as well as the audio webcast and presentation will be accessible on Codere Online’s website at www.codereonline.com. A recording of the webcast will also be available following the conference call.
Reconciliation of Revenue (IFRS) to Net Gaming Revenue (non-IFRS)
Quarter ended September 30
Nine Months ended September 30
Figures in EUR mm
2022
2023
Chg. %
2022
2023
Chg. %
Total
Revenue
28.9
41.1
42%
80.1
115.7
44%
(+) Accounting Adjustments3
1.7
2.2
29%
5.1
6.1
20%
Net Gaming Revenue
30.6
43.2
41%
85.2
121.8
43%
Spain
Revenue
14.9
18.9
27%
42.2
54.9
30%
(+) Accounting Adjustments3
–
–
n.m.
–
–
n.m.
Net Gaming Revenue
14.9
18.9
27%
42.2
54.9
30%
Mexico
Revenue
11.4
18.8
65%
31.0
50.7
64%
(+) Accounting Adjustments3
1.4
2.3
64%
3.8
5.9
55%
Net Gaming Revenue
12.9
21.0
63%
34.8
56.6
63%
Colombia
Revenue
1.8
1.8
–
4.6
6.5
41%
(+) Accounting Adjustments3
0.1
(0.1)
n.m.
1.0
(0.3)
(130%)
Net Gaming Revenue
1.9
1.8
(5%)
5.6
6.2
11%
Other
Revenue
0.7
1.5
114%
2.3
3.6
57%
(+) Accounting Adjustments3
0.2
(0.0)
(100%)
0.4
0.5
25%
Net Gaming Revenue
0.9
1.5
67%
2.7
4.1
52%
About Codere Online Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence in Spain and throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.
About Codere Group Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).
Note on Rounding. Due to decimal rounding, numbers presented throughout this report may not add up precisely to the totals and subtotals provided, and percentages may not precisely reflect the absolute figures.
Forward-Looking Statements Certain statements in this document may constitute “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding Codere Online Luxembourg, S.A. and its subsidiaries (collectively, “Codere Online”) or Codere Online’s or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this document may include, for example, statements about Codere Online’s financial performance and, in particular, the potential evolution and distribution of its net gaming revenue; any prospective and illustrative financial information; and changes in Codere Online’s strategy, future operations and target addressable market, financial position, estimated revenues and losses, projected costs, prospects and plans.
These forward-looking statements are based on information available as of the date of this document and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing Codere Online’s or its management team’s views as of any subsequent date, and Codere Online does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
As a result of a number of known and unknown risks and uncertainties, Codere Online’s actual results or performance may be materially different from those expressed or implied by these forward-looking statements. There may be additional risks that Codere Online does not presently know or that Codere Online currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Some factors that could cause actual results to differ include (i) changes in applicable laws or regulations, including online gaming, privacy, data use and data protection rules and regulations as well as consumers’ heightened expectations regarding proper safeguarding of their personal information, (ii) the impacts and ongoing uncertainties created by regulatory restrictions, changes in perceptions of the gaming industry, changes in policies and increased competition, and geopolitical events such as war, (iii) the ability to implement business plans, forecasts, and other expectations and identify and realize additional opportunities, (iv) the risk of downturns and the possibility of rapid change in the highly competitive industry in which Codere Online operates, (v) the risk that Codere Online and its current and future collaborators are unable to successfully develop and commercialize Codere Online’s services, or experience significant delays in doing so, (vi) the risk that Codere Online may never achieve or sustain profitability, (vii) the risk that Codere Online will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all, (viii) the risk that Codere Online experiences difficulties in managing its growth and expanding operations, (ix) the risk that third-party providers, including the Codere Group, are not able to fully and timely meet their obligations, (x) the risk that the online gaming operations will not provide the expected benefits due to, among other things, the inability to obtain or maintain online gaming licenses in the anticipated time frame or at all, (xi) the risk that Codere Online is unable to secure or protect its intellectual property, and (xii) the possibility that Codere Online may be adversely affected by other political, economic, business, and/or competitive factors. Additional information concerning certain of these and other risk factors is contained in Codere Online’s filings with the U.S. Securities and Exchange Commission (the “SEC”). All subsequent written and oral forward-looking statements concerning Codere Online or other matters and attributable to Codere Online or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above.
Financial Information and Non-GAAP Financial Measures Codere Online’s financial statements are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”), which can differ in certain significant respects from generally accepted accounting principles in the United States of America (“U.S. GAAP”).
This document includes certain financial measures not presented in accordance with U.S. GAAP or IFRS (“non-GAAP”), such as, without limitation, net gaming revenue and Adjusted EBITDA. These non-GAAP financial measures are not measures of financial performance in accordance with U.S. GAAP or IFRS and may exclude items that are significant in understanding and assessing Codere Online’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to revenue, net income, cash flows from operations or other measures of profitability, liquidity or performance under U.S. GAAP or IFRS. You should be aware that Codere Online’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. In addition, the audit of Codere Online’s financial statements in accordance with PCAOB standards, may impact how Codere Online currently calculates its non-GAAP financial measures, and we cannot assure you that there would not be differences, and such differences could be material.
Codere Online believes that the use of these non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing Codere Online’s financial measures with other similar companies, many of which present similar non-GAAP financial measures to investors. These non-GAAP financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-GAAP financial measures. Reconciliations of non-GAAP financial measures to their most directly comparable measure under IFRS are included herein.
This document may include certain projections of non-GAAP financial measures. Codere Online is unable to quantify certain amounts that would be required to be included in the most directly comparable U.S. GAAP or IFRS financial measures without unreasonable effort, due to the inherent difficulty and variability of accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such comparable measures or such reconciliation that have not yet occurred, are out of our control, or cannot be reasonably predicted, ascertained or assessed, which could have a material impact on its future IFRS financial results. Consequently, no disclosure of estimated comparable U.S. GAAP or IFRS measures is included and no reconciliation of the forward-looking non-GAAP financial measures is included.
Use of Projections This document contains financial forecasts with respect to Codere Online’s business and projected financial results, including net gaming revenue and adjusted EBITDA. Codere Online’s independent auditors have not audited, reviewed, compiled or performed any procedures with respect to the projections for the purpose of their inclusion in this document, and accordingly, they did not express an opinion or provide any other form of assurance with respect thereto for the purpose of this document. These projections should not be relied upon as being necessarily indicative of future results. The assumptions and estimates underlying the prospective financial information are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the prospective financial information. See “Forward-Looking Statements” above. Accordingly, there can be no assurance that the prospective results are indicative of the future performance of Codere Online or that actual results will not differ materially from those presented in the prospective financial information. Inclusion of the prospective financial information in this document should not be regarded as a representation by any person that the results contained in the prospective financial information will be achieved.
For further information on the limitations and assumptions underlying these projections, please refer to Codere Online’s filings with the SEC.
Preliminary Information This document contains figures, financial metrics, statistics and other information that is preliminary and subject to change (the “Preliminary Information”). The Preliminary Information has not been audited, reviewed, or compiled by any independent registered public accounting firm. This Preliminary Information is subject to ongoing review including, where applicable, by Codere Online’s independent auditors. Accordingly, no independent registered public accounting firm has expressed an opinion or any other form of assurance with respect to the Preliminary Information. During the course of finalizing such Preliminary Information, adjustments to such Preliminary Information presented herein may be identified, which may be material. Codere Online undertakes no obligation to update or revise the Preliminary Information set forth in this document as a result of new information, future events or otherwise, except as otherwise required by law. The Preliminary Information may differ from actual results. Therefore, you should not place undue reliance upon this Preliminary Information. The Preliminary Information is not a comprehensive statement of financial results, and should not be viewed as a substitute for full financial statements prepared in accordance with IFRS. In addition, the Preliminary Information is not necessarily indicative of the results to be achieved in any future period.
No Offer or Solicitation This document does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.
Industry and Market Data In this document, Codere Online relies on and refers to certain information and statistics obtained from publicly available information and third-party sources, which it believes to be reliable. Codere Online has not independently verified the accuracy or completeness of any such publicly-available and third-party information, does not make any representation as to the accuracy or completeness of such data and does not undertake any obligation to update such data after the date of this document. You are cautioned not to give undue weight to such industry and market data.
Contacts:
Investors and Media Guillermo Lancha Director, Investor Relations and Communications Guillermo.Lancha@codere.com (+34)-628-928-152
1 Net Gaming Revenue is a non-IFRS measure. Please see reconciliation of Net Gaming Revenue to Revenue at the end of the report. 2 Average Monthly Active Players include real money (i.e. exclude free bets) sports betting and casino actives and will differ from certain prior period reports which only included real money sports betting actives. 3 Figures primarily reflect differences in recognition of revenue related to certain partner and affiliate agreements in place in Colombia and VAT impact from entry fees in Mexico.
RESILIENT is expected to be the final efficacy trial required for submission of a New Drug Application to FDA; first successful Phase 3 trial, RELIEF, achieved statistical significance (p=0.010)
Preliminary unaudited rate of adverse-event (AE) related discontinuations in the RESILIENT study was 4.8% which compares favorably with prior studies: RELIEF 6.0% and RALLY 10.7%
TNX-102 SL is a centrally acting, non-opioid analgesic
CHATHAM, N.J., Nov. 15, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical phase of the Phase 3 registration-quality, double-blind, placebo-controlled RESILIENT1 study of TNX-102 SL2 (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. A total of 457 patients were enrolled in this multi-site study in the U.S. Topline results are expected in late December 2023. If successful, it is expected to be the final, well-controlled efficacy trial required for submission of a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA).
“There are an estimated 6-12 million individuals in the U.S. suffering from this debilitating condition, most of whom are women,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-102 SL is a centrally-acting, non-opioid analgesic bedtime medication designed to be used on a chronic basis for the management of fibromyalgia. We believe TNX-102 SL works by improving sleep quality, which leads to improvement of other symptoms. In previous studies, TNX-102 SL showed broad coverage across the symptoms of fibromyalgia, including chronic widespread pain, fatigue and sleep disturbance.”
“The preliminary unaudited rate of adverse-event (AE) related discontinuations in the RESILIENT study was 4.8%,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “This compares favorably to the blinded AE-related discontinuation rates in our two previous Phase 3 trials: 6.0% in RELIEF which achieved statistical significance on the primary endpoint (p=0.010), and 10.7% in RALLY which was stopped at the interim analysis. We later learned that an unexpectedly high rate of AE-related discontinuations in RALLY contributed to missing the primary endpoint. The study was conducted during the Delta wave of the COVID pandemic, which we believe may have contributed to patient discontinuations. AE-related discontinuations are treated as negative outcomes in the ‘missing data’ multiple imputation approach that is part of the analysis of the primary endpoint.”
In December 2020, Tonix reported positive results from the first Phase 3 RELIEF study of TNX-102 SL 5.6 mg for the management of fibromyalgia.3 TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.010) in participants with fibromyalgia. Also, when the primary endpoint was analyzed as a ≥30% pain responder analysis, there was a higher rate of responders to TNX-102 SL (47%) than to placebo (35%; p=0.006). TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints, demonstrating improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific global symptomatic and functional recovery. TNX-102 SL was generally safe and well tolerated in patients with fibromyalgia, with overall adverse event profile comparable to prior fibromyalgia studies. The most common treatment-emergent adverse events were oral hypoesthesia, oral paresthesia, and product taste abnormal.
1Clinical Trials.gov I.D. NCT05273749 2TNX-102 SL is an investigational new drug and is not approved for any indication. 3Lederman S, et al. Arthritis Care Res. 2023. 75(11):2359-2368.
About the Phase 3 RESILIENT Study
The RESILIENT study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in the management of fibromyalgia. The two-arm trial randomized 457 participants across 33 sites in the U.S. The first two weeks of treatment consist of a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increase their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint is the daily diary pain severity score change from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores) for TNX-102 SL 5.6 mg vs. placebo, analyzed by mixed model repeated measures with multiple imputation.
For more information, see ClinicalTrials.gov Identifier: NCT05273749.
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.
About TNX-102 SL
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment for chronic migraine, and enrollment has been completed in a Phase 2 proof-of-concept study with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity, bone health in autism, and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
*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. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. 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.
Washington State Department of Agriculture Fertilizer Registration Certificate received to commence sales of TerraSanteTM crop fertilizer and soil amendment product in Washington State.
MustGrow’s recently-awarded organic compliance certification from the USDA National Organic Program (OMRI Listed®) will apply to this Registration.
Mustard-derived TerraSanteTM focuses on soil microbiome health, nutrient/water use efficiencies, and plant yields.
MustGrow is committed to launching mustard-derived innovative, sustainable, and regenerative agriculture products.
SASKATOON, Saskatchewan, Canada, November 15, 2023 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to announce receipt of the Washington State Department of Agriculture Fertilizer Registration Certificate for its mustard plant-based TerraSanteTM crop fertilizer and soil amendment product. TerraSanteTM’s recently-awarded organic compliance certification from the USDA National Organic Program (OMRI Listed®) will apply to TerraSanteTM product sales in Washington State.
TerraSanteTM product sales can now commence in Washington State, with a sales & marketing commercialization strategy already forming in conjunction with BioAg Product Strategies for the 2024 planting season. In addition to Washington State, registration work is progressing rapidly in other key U.S. states.
“With our first state government registration approval, we have cleared the final requirement to commence TerraSanteTM commercial sales,” commented MustGrow’s President & CEO, Corey Giasson. “Agriculture needs new organic innovations to support food production and MustGrow has answered the call. This product approval demonstrates our ability to execute and also have a meaningful impact on the key U.S. agricultural regions that are under constant pressure to eliminate or reduce synthetic products and increase the use of natural biologics such as TerraSanteTM.”
In 2019, Washington State agriculture production totaled USD $9.49 billion. Washington State’s rich soils, diverse climates, and large-scale irrigation nurtures production of over 300 different crops in one of the most world’s productive agricultural regions. For example, Washington State is the nation’s largest producer of apples, blueberries, hops, pears, spearmint oil, and sweet cherries; and the number two producer of apricots, asparagus, dry onions, grapes, potatoes, raspberries, and winter wheat. Organic acres total 105,660, representing USD $652 million in total farm gate sales, with another 7,824 acres in certified organic transition.(1)
MustGrow believes this soil amendment and biofertility initiative will complement its existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide, which are currently under development with four global partners: Janssen PMP, Bayer, Sumitomo Corporation, and NexusBioAg. These four partnered programs continue to achieve performance milestones and expand globally in scope and investment.
TerraSanteTM for Soil and Ecological Health
MustGrow’s soil amendment and biofertility development programs will focus on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields. Soil is a farmer’s most valuable and precious asset, and MustGrow’s mustard plant-based technologies are being developed with the intention to improve not only the health of the soil, but also the surrounding ecological environment.
As a soil amendment in mixable form, TerraSanteTM contains nutritious plant proteins and carbohydrates that feed soil microbes, potentially improving beneficial microbial activity and ensuring long-term sustainable soil health. These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress. TerraSanteTM has the potential to improve crop nutrient uptake and, hence, overall crop performance. There are no artificial additives or preservatives used during its manufacturing.
MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertily markets. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility. MustGrow has approximately 50.1 million basic common shares issued and outstanding and 55.0 million shares fully diluted. For further details, please visit www.mustgrow.ca.
Contact Information
Corey Giasson Director & CEO Phone: +1-306-668-2652 info@mustgrow.ca
MustGrow Forward-Looking Statements
Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.
Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: the Company’s commitment to launching mustard-derived innovative, sustainable, and regenerative agriculture products; the formation of sales & marketing commercialization strategy for Washington State; the expected progression of registration work in other key U.S. states; and whether the soil amendment and biofertility initiative will complement its existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide.
Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2022 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.
This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.
Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.
CULVER CITY, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL), a leading, global independent developer and publisher of interactive digital entertainment, announced today that it will report financial results for the third quarter ended September 30, 2023, today, November 14, 2023, after the U.S. stock market closes. Management will host a conference call and webcast today at 5:00 p.m. ET to discuss the results.
Participants may listen to the live webcast and replay on the Company’s investor relations website at https://investor.snail.com/.
About Snail, Inc. Snail 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, PCs, and mobile devices.
LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands (NYSE: ACCO), a world leader in branded consumer and end user products, was named one of America’s Safest Companies in 2023 by EHS Today. The magazine for environment, health, and safety leaders, announced its list of the 2023 America’s Safest Companies last month with 10 companies on the list. These companies are involved in a broad range of activities, from industrial contracting to robotics, from packaging to cabinetry, from consumer packaged goods to electrical construction, and more.
ACCO Brands was among the outstanding companies being honored because of a committed understanding of the value that safety brings to an organization. This is the third time that ACCO Brands has been awarded this title, something only six other companies have achieved.
For more than 20 years, the America’s Safest Companies competition has sought to identify those characteristics that differentiate good safety programs from great ones, and to then celebrate the best practices and procedures that exemplify safety excellence.
“Every America’s Safest Company winner is a standard-bearer of safety excellence. Each winning company has engrained into their culture and their employees a consistent and constant need to keep every person and every situation free from harm,” said EHS Today Editor-in-Chief Dave Blanchard.
To be considered as one of America’s Safest Companies, organizations must complete an application that requires them to demonstrate excellence in several areas: support from leadership and management for EHS efforts; employee involvement in the EHS process; innovative solutions to safety challenges; injury and illness rates lower than the average for their industries; comprehensive training programs; evidence that prevention of incidents is the cornerstone of the safety process; good communication about the value of safety; and a way to substantiate the benefits of the safety process.
As a company with a personal stake in all things ergonomic, ACCO Brands understands the discomfort of aches and pains. That is why the company provides on-site massages using the certified active release technique (ART) to all U.S. manufacturing and distribution center employees—regardless of whether those aches and pains are job-related or not.
“While there is a significant cost to providing the ART benefit to our employees, we believe we have prevented many minor employee issues from becoming more serious medical issues and have a healthier workforce as a result of this program,” says James Edwards, senior director of environmental, health and safety, ACCO Brands.
The best practices from the 2023 America’s Safest Companies are featured in a special section in the July/August 2023 issue of EHS Today magazine and on the brand’s website, www.ehstoday.com. Since 2002, America’s Safest Companies has honored more than 250 organizations for their unwavering commitment to worker safety, health, and environmental stewardship.
About ACCO Brands 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, play, and thrive. 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.
About EHS Today Owned by Endeavor Business Media, EHS Today is an American occupational safety, and health media brand. It is the leading US magazine for environmental, health and safety management professionals in the manufacturing, construction, and service sectors.
Single-Dose Protection Demonstrated Against Multiple SARS-CoV-2 Variants
Atlanta, GA, November 14, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the presentation of preclinical vaccine efficacy data for GEO-CM02, a multi-antigen investigational SARS-CoV-2 vaccine. The data were presented during the Vaccines Summit 2023 conference, being held in Boston, MA on November 13-15, 2023. The presentation, titled “MVA-vectored multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal models,” was delivered by Mukesh Kumar, PhD, Associate Professor, Department of Biology, Georgia State University.
“We are thrilled to continue to demonstrate the robust efficacy profile of GEO-CM02 with the presentation of preclinical data at this year’s Vaccine Summit,” said David Dodd, GeoVax’s Chairman and CEO. “Together, these data indicate that immunization with the multi-antigen GEO-CM02 vaccine can protect against severe disease and death induced by SARS-CoV-2 infection and regardless of the variant. Along with a demonstrated safety profile, we believe GEO-CM02 has potential as a transformative universal coronavirus vaccine.”
First-generation SARS-CoV-2 vaccines based on the spike (S) protein have demonstrated that they induce neutralizing antibodies, providing effective, albeit short-term levels of immune protection. Unfortunately, with the existing authorized vaccines, efficacy is disrupted by emerging variants that contribute to neutralizing antibody evasion, requiring continuous updating and booster doses. To address this limitation, GeoVax is currently evaluating its dual antigen COVID-19 vaccine, GEO-CM04S1 in three Phase 2 clinical trials. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating. Moreover, GEO-CM04S1 is being developed specifically as a COVID-19 vaccine in support of patients with compromised immune systems, for whom the current authorized vaccines appear inadequate in providing protective immunity.
GEO-CM02 is a multi-antigen SARS-CoV-2 vaccine, based on the S, membrane (M), and envelope (E) proteins, which are designed to also engage both the humoral (antibody) and cellular (T-cell) arms of the immune system and to broaden both the function and specificity, potentially as a universal coronavirus vaccine. Efficacy of this investigational vaccine was tested using the industry standard, lethal hACE2 transgenic mouse model.
Data highlights from the Vaccine Summit 2023 presentation are as follows:
The GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose.
Animals were protected prior to the detection of neutralizing antibodies, likely indicating a critical T-cell contribution.
GEO-CM02 significantly reduced or eliminated inflammation and immunopathology in the lungs of vaccinated animals.
The data generated in the GEO-CM02 studies validate GeoVax’s hypothesis that vaccines designed to induce both antibodies and T-cells to multiple viral structural proteins can address the issue of viral variation and escape from the immune system. GEO-CM02 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose.
GeoVax’s more advanced, next-generation COVID-19 vaccine, GEO-CM04S1, is being evaluated in three ongoing Phase 2 clinical trials:
As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. GeoVax recently announced clinical site expansion for this trial.
As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466. GeoVax recently announced that this trial has fully enrolled.
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.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
The Last Great Hamburger Stand Set to Debut in Hidalgo County
LOS ANGELES, Nov. 14, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Fatburger and 17 other restaurant concepts, announces a new development deal set to bring six additional franchised Fatburger locations to Hidalgo County, Texas in the next five years. The news comes on the heels of the recent opening of the first co-branded Fatburger and Round Table Pizza restaurant in Lantana, Texas.
“The Fatburger brand continues to expand in Texas,” said Taylor Wiederhorn, Chief Development Officer of FAT Brands. “Fatburger has a pipeline of approximately 50 restaurants to be built in Texas alone and the franchisee demand to develop more Fatburger restaurants throughout the state has not slowed down. We look forward to adding six more restaurants to our existing development pipeline in Texas with further growth near the southern border.”
Ever since the first Fatburger opened in Los Angeles 70 years ago, the chain has been known for its delicious, grilled-to-perfection and cooked-to-order burgers. Founder Lovie Yancey believed that a big burger with everything on it is a meal in itself; at Fatburger “everything” is not just the usual roster of toppings. Burgers can be customized with everything from bacon and eggs to chili and onion rings. In addition to its famous burgers, the Fatburger menu also includes Fat and Skinny Fries, sweet potato fries, scratch-made onion rings, Impossible™ Burgers, turkeyburgers, hand-breaded crispy chicken sandwiches, and hand-scooped milkshakes made from 100 percent real ice cream.
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual, quick-service, casual and polished casual dining restaurant concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Smokey Bones, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.
About Fatburger An all-American, Hollywood favorite, Fatburger is a fast-casual restaurant serving big, juicy, tasty burgers, crafted specifically to each customer’s liking. With a legacy spanning 70 years, Fatburger’s extraordinary quality and taste inspire fierce loyalty amongst its fan base, which includes a number of A-list celebrities and athletes. Featuring a contemporary design and ambiance, Fatburger offers an unparalleled dining experience, demonstrating the same dedication to serving gourmet, homemade, custom-built burgers as it has since 1952 – The Last Great Hamburger Stand™.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the future financial and operating results of the Company, estimates of future EBITDA, the timing and performance of new store openings, future reductions in cost of capital and leverage ratio, our ability to conduct future accretive acquisitions and our pipeline of new store locations. Forward-looking statements generally use words such as “expect,” “foresee,” “anticipate,” “believe,” “project,” “should,” “estimate,” “will,” “plans,” “forecast,” and similar expressions, and reflect our expectations concerning the future. Forward-looking statements are subject to significant business, economic and competitive risks, uncertainties and contingencies, many of which are difficult to predict and beyond our control, which could cause our actual results to differ materially from the results expressed or implied in such forward-looking statements. We refer you to the documents that we file from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other risks and uncertainties that could cause our actual results to differ materially from our current expectations and from the forward-looking statements contained in this press release. We undertake no obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of this press release.
Company Secures Preferred Vendor Status for Bitcoin ATM Services to AATAC’s 50,000 Members
ATLANTA, Nov. 14, 2023 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”) (NASDAQ: BTM), a U.S.-based Bitcoin ATM operator and leading fintech company, today announced it has been named a preferred vendor with the AATAC, a national trade association of retailers, distributors, vendor suppliers and partners for the convenience store and retail industries. Bitcoin Depot is the first BTM company to have gained recognition as a preferred vendor for AATAC, strengthening Bitcoin Depot’s value proposition.
“Bitcoin Depot is proud to work with the AATAC as the association’s preferred BTM vendor, which introduces our company to AATAC’s 50,000 associated retailers nationwide,” said Bitcoin Depot CEO Brandon Mintz. “This is another milestone in our mission to bring Bitcoin to the masses.”
Bitcoin Depot is listed as a preferred ATM & Credit vendor on the AATAC website. The Company attended an AATAC trade show this year to meet with AATAC customers and members.
“We are thrilled to offer Bitcoin Depot’s services for our members,” said Ivy LaBrie, Operations Director at AATAC. “Our network of retailers represents an incomparable buying power, and we’re proud to connect them with quality, trusted companies such as Bitcoin Depot that will expand their service offerings.”
AATAC is a national association comprised of smaller buying groups, regional sub-chapters, independents, and other trade organizations under one blanket that consist of over 50,000 operators controlling over 80,000 locations across the U.S. and Puerto Rico. Currently, there are approximately 150,000 AATAC-associated C-stores in the country.
About Bitcoin Depot Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to Bitcoin at Bitcoin Depot’s kiosks and at thousands of name-brand retail locations through its BDCheckout product. The Company has the largest market share in North America with approximately 6,400 kiosk locations as of September 30, 2023. Learn more at www.bitcoindepot.com
About AATAC AATAC is a national association comprised of smaller buying groups, regional sub-chapters, independents, and other trade organizations under one blanket that consist of over 50,000 operators controlling over 80,000 locations across the U.S. and Puerto Rico.
Contacts:
Investors Cody Slach, Alex Kovtun Gateway Group, Inc. 949-574-3860 BTM@gateway-grp.com
Media Zach Kadletz, Brenlyn Motlagh, Ryan Deloney Gateway Group, Inc. 949-574-3860 BTM@gateway-grp.com
New Contract and Contract Renewal Momentum Continues
BRENTWOOD, Tenn., Nov. 14, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic”) announced today it signed a new management contract with the state of Montana for the housing of up to 120 inmates at the Company’s 1,896-bed Saguaro Correctional Facility in Eloy, Arizona.
The new management contract commences immediately and ends October 31, 2025. The contract may be extended by mutual agreement. The total term, including renewals, may not exceed seven years. We anticipate completing the receipt of the inmates from Montana at the Saguaro facility by December 31, 2023.
Damon T. Hininger, President and Chief Executive Officer commented, “We are grateful for our longstanding partnership with the Montana Department of Corrections and honored by the opportunity to meet their evolving needs at both our Crossroads Correctional Facility in Shelby, Montana as well as at our Saguaro Correctional Facility in Eloy, Arizona. Our modern Saguaro facility, built in 2007, will now care for incarcerated individuals for three different state partners.”
Hininger continued, “This new contract further reflects the attractiveness of our available bed capacity as well as the high level of service and trust for which CoreCivic is recognized. We continue to anticipate heightened need for our modern and flexible capacity from states and local agencies, as well as from Federal partners.”
About CoreCivic
CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest prison operators in the United States. We have been a flexible and dependable partner for government for 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.
Forward-Looking Statements
This press release contains statements as to our beliefs and expectations of the outcome of future events that are “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. These include, but are not limited to, the risks and uncertainties associated with: (i) changes in government policy, legislation and regulations that affect utilization of the private sector for corrections, detention, and residential reentry services, in general, or our business, in particular, including, but not limited to, the continued utilization of our correctional and detention facilities by the federal government, including as a consequence of the United States Department of Justice, or DOJ, not renewing contracts as a result of President Biden’s Executive Order on Reforming Our Incarceration System to Eliminate the Use of Privately Operated Criminal Detention Facilities, impacting utilization primarily by the Federal Bureau of Prisons and the United States Marshals Service, and the impact of any changes to immigration reform and sentencing laws (we do not, under longstanding policy, lobby for or against policies or legislation that would determine the basis for, or duration of, an individual’s incarceration or detention); (ii) our ability to obtain and maintain correctional, detention, and residential reentry facility management contracts because of reasons including, but not limited to, sufficient governmental appropriations, contract compliance, negative publicity and effects of inmate disturbances; (iii) changes in the privatization of the corrections and detention industry, the acceptance of our services, the timing of the opening of new facilities and the commencement of new management contracts (including the extent and pace at which new contracts are utilized), as well as our ability to utilize available beds; (iv) general economic and market conditions, including, but not limited to, the impact governmental budgets can have on our contract renewals and renegotiations, per diem rates, and occupancy; (v) fluctuations in our operating results because of, among other things, changes in occupancy levels; competition; contract renegotiations or terminations; inflation and other increases in costs of operations, including a continuing rise in labor costs; fluctuations in interest rates and risks of operations; (vi) the impact resulting from the termination of Title 42, the federal government’s policy to deny entry at the United States southern border to asylum-seekers and anyone crossing the southern border without proper documentation or authority in an effort to contain the spread of the coronavirus and related variants, or COVID-19; (vii) government budget uncertainty, the impact of the debt ceiling and the potential for government shutdowns and changing funding priorities; (viii) our ability to successfully identify and consummate future development and acquisition opportunities and realize projected returns resulting therefrom; (ix) our ability to have met and maintained qualification for taxation as a real estate investment trust, or REIT, for the years we elected REIT status; and (x) the availability of debt and equity financing on terms that are favorable to us, or at all. Other factors that could cause operating and financial results to differ are described in the filings we make from time to time with the Securities and Exchange Commission.
We take no responsibility for updating the information contained in this press release following the date hereof to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events or for any changes or modifications made to this press release or the information contained herein by any third-parties, including, but not limited to, any wire or internet services.
Contact:
Investors: Michael Grant – Managing Director, Investor Relations – (615) 263-6957
Financial Media: David Gutierrez, Dresner Corporate Services – (312) 780-7204
Announced 75% of ICI-naive patients alive at 36 months in the NCI-led triple Phase 2 combination trial for advanced HPV16-positive cancer patients; published median overall survival of 7-11 months with FDA approved ICI1
Announced 2-year overall survival rate of 74% in VERSATILE-002 Phase 2 trial of ICI-naïve HPV16-positive recurrent or metastatic head and neck cancer patients; published 2-year overall survival of less than 30% with FDA approved ICI1
Announced interim safety and immune response data for Phase 1/2 clinical trial evaluating docetaxel and PDS01ADC in metastatic prostate cancer patients; PSA decline was seen in all 18 patients and 61% of patients had at least a 60% decrease in PSA levels
Company to host conference call and webcast today at 8:00 AM EST
PRINCETON, N.J., Nov. 14, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced its financial results for the quarter ended September 30, 2023. The Company will provide a business update on its conference call and webcast at 8:00 AM EST today.
CEO Comments: “We are pleased with the outcome of the National Cancer Institute (NCI)-led Phase 2 triple combination trial of PDS0101, PDS01ADC (formerly known as PDS0301) and an investigational immune checkpoint ihnibitor (ICI). The data show that 75% of immune checkpoint inhibitor (ICI)-naïve patients remain alive at three years, and the 12-month overall survival (OS) rate in the ICI-resistant patients is 72%,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Furthermore, the triple combination continues to be well tolerated, with only 4% of patients reported to have Grade 4 treatment-related adverse events.”
He continued, “As the development of our IL12 fused antibody-drug conjugate or ADC, PDS01ADC, continues to progress, its potential to overcome key safety and efficacy limitations associated with existing cytokine therapy is reinforced. Data presented at Cytokines 2023 marked the first-in-human clinical trial evaluating the combination of docetaxel chemotherapy and PDS01ADC to treat advanced metastatic castration sensitive (mCSPC) and castration resistant prostate cancer (mCRPC). Decreases in prostate-specific antigen (PSA) levels were reported in all patients. In addition, with our lead candidate PDS0101, the interim Phase 2 VERSATILE-002 data presented during our Key Opinion Leader (KOL) roundtable showed a 2-year overall survival rate of 74% in ICI-naïve human papillomavirus (HPV)16- recurrent/metastatic head and neck cancer patients. We are excited about the strides we are making across our pipeline, fueled by our commitment to developing groundbreaking therapies that revolutionize cancer treatments.”
Recent Business Highlights: PDS0101 Lead Drug Candidate
VERSATILE-003: Received feedback from the U.S. Food and Drug Administration (FDA) regarding the Phase 3 clinical protocol for a randomized, controlled multicenter trial of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with HPV16-positive recurrent and/or metastatic head and neck cancer. PDS Biotech anticipates initiation of VERSATILE-003 in Q1 2024.
VERSATILE-002: Phase 2 open-label, multicenter clinical trial of PDS0101 in combination with KEYTRUDA® in patients with HPV16-positive recurrent and/or metastatic head and neck cancer.
Hosted KOL roundtable on interim VERSATILE-002 data and current and future treatments. Highlights from ICI-naïve patients:
24-month OS rate of 74%; published 24-month OS less than 30% data with approved ICIs for head and neck cancer.2
Well tolerated with no patients having Grade 4 or 5 combination treatment-related adverse events. Thirteen percent with Grade 3 combination treatment-related adverse events.
Presented biomarker data at European Society for Medical Oncology Congress 2023, highlighting that the combination of PDS0101 and KEYTRUDA® has the potential to promote a TH1 immune response which is known to promote a strong CD8 T cell response. Biomarker data demonstrated that the combination promotes the induction of HPV16-specific multifunctional CD8 T cells.
IMMUNOCERV: Phase 2 clinical trial investigating PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy (CRT) in the treatment of locally advanced cervical cancer patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes.
Data presented at American Society for Radiation Oncology 2023 Annual Meeting demonstrated PDS0101, in combination with SOC CRT, was associated with a rapid decline in HPV circulating cell-free DNA, a potential predictive biomarker of treatment response. Ninety-two percent reduction in ctDNA with PDS0101 and SOC and 53% reduction was seen with SOC at 5 weeks.
PDS01ADC (formerly known as PDS0301): IL12 Fused Antibody Drug Conjugate
NCI-led Triple Combination: Phase 2 clinical trial for combination therapy of PDS0101, PDS01ADC and an investigational ICI for the treatment of recurrent/metastatic HPV-positive, ICI-naïve and ICI-resistant HPV16-positive cancers including anal, cervical, head and neck, vaginal and vulvar cancers.
ICI-naïve group:
75% of patients remain alive at 36 months; published median OS data in similar patients is 7-11 months.1 The median OS has not yet been reached.
ICI-resistant group:
12-month OS rate of 72%.
Median OS approximately 20 months; published median OS in HPV-positive ICI-resistant cancer is 3.4 months3.
Responses were seen in all HPV-positive tumor types.
NCI-led PDS01ADC + Docetaxel: Phase 1/2, open-label, single-arm trial of PDS01ADC in combination with docetaxel in advanced mCSPC and mCRPC.
Presented interim safety and immune response data of the combination in the first clinical trial of an immunocytokine with docetaxel in prostate cancer patients at Cytokines 2023.
Decrease in PSA levels was seen in all patients at all three tested doses of PDS01ADC and 61% of patients had at least a 60% decrease in PSA levels.
All doses of the combination were well tolerated with one patient experiencing Grade 4 neutropenia.
Presented data from the NCI-led preclinical study evaluating PDS0101, PDS01ADC and an HDAC inhibitor at the Society for Immunotherapy of Cancer’s 38th Annual Meeting, demonstrating antitumor activity against ICI-resistant cancers.
PDS0202 Universal Flu Candidate
Presented data from the preclinical universal flu vaccine program at 9th European Scientific Working Group on Influenza, demonstrating the potential ability of PDS0202 to neutralize multiple influenza viruses. PDS0202 also demonstrated the ability to prevent viral replication in the lungs of ferrets and provide complete protection after challenge with lethal doses of the H1N1 influenza virus.
Third Quarter 2023 Financial Results Net loss for the three months ended September 30, 2023 was approximately $10.8 million, or $0.35 per basic share and diluted share, compared to a net loss of approximately $7.4 million, or $0.26 per basic and diluted share, for the three months ended September 30, 2022. The higher net loss reported for the three months ended September 30, 2023 is primarily due to the increase in research and development expenses and general and administrative expenses.
Research and development expenses increased to $6.4 million for the three months ended September 30, 2023 from $4.4 million for the three months ended September 30, 2022. The increase of $2.0 million is primarily attributable to an increase of $1.3 million in clinical trials, and $0.7 million in personnel costs, including $0.3 million in non-cash stock-based compensation.
General and administrative expenses increased to $4.1 million for the three months ended September 30, 2023 from $2.9 million for the three months ended September 30, 2022. The increase of $1.2 million is primarily attributable to an increase of $0.7 million in personnel costs, including $0.5 million in non-cash stock-based compensation, and $0.5 million in investor relations costs.
PDS Biotech’s cash balance as of September 30, 2023 was approximately $54.3 million. PDS Biotech believes that, with initiating the VERSATILE-003 Phase 3 clinical trial in the first quarter of 2024, its available cash resources will sustain operational and research and development endeavors into the third quarter of 2024. PDS Biotech expects to execute its current operational and research and development endeavors by obtaining additional capital, principally through entering into collaborations, strategic alliances or license agreements with third parties and/or additional public or private debt and/or equity financings. The Company has had and continues to provide, what the Company believes to be favorable development milestones to the market and has upcoming development milestones.
Conference Call and Webcast The conference call is scheduled to begin at 8:00 AM EST today, November 14, 2023. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13741454. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.
1 Baumi J, et al. J Clin Oncol 2017:1542-49 and Morris VK, et al. Lancet Oncol 2017;18:446-53.
2Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B et al., Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE- 048): a randomized, open-label phase 3 study; Lancet 2019; 394(10212):1915-1928. *No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101. https://www.opdivo.com/head-and-neck-cancer https://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/
3 Strauss J et al. Journal for ImmunoTherapyof Cancer 2020;8:e001395
About PDB Biotechnology PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS01ADC, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and plan to advance into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in the first quarter 2024. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
About PDS0101 PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically active immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.
About PDS01ADC PDS01ADC, formerly PDS0301, is a novel investigational tumor-targeting antibody drug conjugate of Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells and natural killer cells in the tumor microenvironment. PDS01ADC is given by subcutaneous injection and is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.
Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; the Company’s ability to continue as a going concern; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.
Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2023 and December 31, 2022, 31,007,763 shares and 30,170,317 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively
10,233
9,956
Additional paid-in capital
158,075,994
145,550,491
Accumulated deficit
(133,602,399
)
(101,558,417
)
Total stockholders’ equity
24,483,828
44,002,030
Total liabilities and stockholders’ equity
$
57,187,821
$
77,007,923
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
Operating expenses:
Research and development expenses
$
6,448,528
$
4,352,987
$
20,297,066
$
13,275,947
General and administrative expenses
4,071,158
2,926,209
12,341,207
9,575,122
Total operating expenses
10,519,686
7,279,196
32,638,273
22,851,069
Loss from operations
(10,519,686
)
(7,279,196
)
(32,638,273
)
(22,851,069
)
Interest income (expenses), net
Interest income
739,404
252,073
2,219,399
332,318
Interest expense
(1,068,887
)
(397,327
)
(3,031,129
)
(397,326
)
Interest income (expenses), net
(329,483
)
(145,254
)
(811,730
)
(65,008
)
Loss before income taxes
(10,849,169
)
(7,424,450
)
(33,450,003
)
(22,916,077
)
Benefit for income taxes
–
–
1,406,021
1,198,905
Net loss and comprehensive loss
(10,849,169
)
(7,424,450
)
(32,043,982
)
(21,717,172
)
Per share information:
Net loss per share, basic and diluted
$
(0.35
)
$
(0.26
)
$
(1.04
)
$
(0.76
)
Weighted average common shares outstanding, basic, and diluted
30,910,520
28,458,688
30,715,458
28,452,997
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Nine Months Ended September 30,
2023
2022
Cash flows from operating activities:
Net loss
$
(32,043,982
)
$
(21,717,172
)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
6,259,464
3,821,923
Issuance of shares in consulting agreement
610,000
–
Amortization of debt discount
391,920
72,722
Depreciation expense
12,624
86
Operating lease expense
160,685
180,772
Finance lease depreciation expense
30,297
37,417
Changes in assets and liabilities:
Prepaid expenses and other assets
73,205
(1,171,337
)
Finance lease right-of-use asset
–
(306,487
)
Accounts payable
4,147,277
727,987
Accrued expenses
(4,580,981
)
240,799
Finance lease liabilities
–
138,402
Operating lease liabilities
(239,469
)
(205,885
)
Net cash used in operating activities
(25,178,960
)
(18,180,773
)
Cash Flows from financing activities:
Proceeds from issuance of note payable
–
25,000,000
Payment for debt issuance costs
–
(449,329
)
Proceeds from exercise of stock options
8,849
29,917
Payments of finance lease obligations
(46,129
)
–
Proceeds from issuance of common stock, net of issuance costs
