MALVERN, Pa., Feb. 03, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the European Commission has provided a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU400 Advanced Therapy Medicinal Product (ATMP) classification. OCU400 is the first gene therapy to enter Phase 3 with a broad retinitis pigmentosa (RP) indication.
“Receiving ATMP classification is another significant milestone toward bringing OCU400 to the market in Europe,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This designation makes it possible to stay on track with our clinical and commercial strategy and potentially provide this novel modifier gene therapy candidate to all RP patients in the United States (U.S.) and Europe by 2027.”
ATMP classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential one-time gene therapy for life. Additionally, this classification allows Ocugen to interact with EMA more frequently for scientific advice and protocol assistance as the Company pursues Marketing Authorization Application (MAA) filing in 2026.
Underscoring the vital need for gene-agnostic treatments for diseases with multiple mutations such as RP, both the U.S. Food and Drug Administration (FDA) and EMA have acknowledged that the ongoing single, pivotal Phase 3 trial of OCU400 can suffice for Biologics License Application (BLA)/MAA submissions. Ocugen intends to file simultaneously in the U.S. and Europe upon completion of the Phase 3 trial.
The Phase 3 OCU400 liMeliGhT clinical trial is currently enrolling. The study has a sample size of 150 participants—one arm of 75 participants with RHO gene mutations and the other arm with 75 participants that are gene agnostic. In each arm, participants will be randomized 2:1 to the treatment group (2.5 x 1010 vg/eye of OCU400) and untreated control group, respectively. Patients eight years of age and older, with early through late-stage advancement of RP, are being recruited to participate in the liMeliGhT study.
“We are encouraged by the EMA’s recognition of OCU400 as the Phase 3 liMeliGhT clinical trial advances,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “I look forward to working collaboratively with the EMA to address the unmet medical need that remains for nearly 98% of the RP patient population.”
RP affects nearly 310,000 patients in the U.S., EU, and Canada. Currently, RP is associated with mutations in more than 100 genes and there are no approved treatment options that slow or stop the progression of multiple forms of RP.
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with inherited retinal diseases.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements
Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including,butnotlimitedto,therisksthatpreliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;the ability of OCU400 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingofmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subject to differing interpretations and assessments, including by regulatory authorities.Theseandotherrisksanduncertaintiesaremorefully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, plans to report its fourth-quarter and full-year 2024 financial results on Wednesday, February 12 before market open. Management will present the results during a conference call and webcast at 9:00 a.m. ET.
The call will be available by live audio cast along with the news release and online presentation slides at https://investor.conduent.com .
The conference call will also be available by calling 877-407-4019 toll free. If requested, the conference ID 13750544.
The international dial-in is +1 201-689-8337. The international conference ID is also 13750544.
A recording of the conference call will be available by calling 877-660-6853 three hours after the conference call concludes. The access ID for the recording is 13750544.
The call recording will be available until February 26, 2025.
We look forward to your participation.
About Conduent Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 55,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com .
Trademarks Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.
Generates Revenues of $775.5 million and Net Income of $64.3 million
Reports Adjusted EBITDA(1) of $116.3 million
Updates Fiscal Year 2025 Outlook
(1) Refer to “Definitions of Non-GAAP Financial Measures” and the tables attached at the end of this press release for reconciliation of non-GAAP results to applicable GAAP results.
JERICHO, N.Y.–(BUSINESS WIRE)– 1-800-FLOWERS.COM, Inc. (NASDAQ: FLWS), a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships, today reported results for its Fiscal 2025 second quarter ended December 29, 2024.
“Our second quarter revenue declined 5.7%, showing year-over-year improvement, but not at the pace that we had been anticipating,” said Jim McCann, Chairman and Chief Executive Officer of 1-800-FLOWERS.COM, Inc. “Our business experienced a softer than anticipated and highly promotional consumer environment, along with a pullback in corporate gifting orders, which were slightly offset by an improvement in our wholesale business. These trends were further exacerbated by issues with our new Harry & David order management system implementation.”
Mr. McCann continued, “Shifting patterns in consumer engagement have affected our performance. We are implementing actions to accelerate our Work Smarter efficiency initiatives that will in turn fund investments in our growth-oriented Relationship Innovation™ initiatives and marketing and sales strategies. As we focus on expanding our customer base, we see significant opportunities to leverage new technology to enhance engagement and build deeper relationships with our customers. We are confident that our dedicated team and innovative solutions will help us navigate these headwinds and emerge stronger.”
Fiscal 2025 Second Quarter Highlights
Total consolidated revenues decreased 5.7% to $775.5 million, as compared with the prior year period.
Gross profit margin of 43.3% was flat with the prior year period.
Operating expenses declined $19.9 million to $244.5 million, as compared with the prior year period. Excluding the impact of non-recurring charges in the current period associated with new systems implementation costs, impairment charges in the prior year period, as well as the impact of the Company’s non-qualified deferred compensation plan in both periods, operating expenses declined by $2.9 million to $239.1 million, as compared with the prior year period.
Net income for the quarter was $64.3 million, or $1.00 per diluted share, as compared with net income of $62.9 million, or $0.97 per diluted share in the prior year period.
Adjusted Net Income1 was $69.2 million, or $1.08 per diluted share, compared with an Adjusted Net Income1 of $82.7 million, or $1.27 per diluted share, in the prior year period.
Adjusted EBITDA1 for the quarter was $116.3 million, as compared with Adjusted EBITDA1 of $130.1 million in the prior year period.
Segment Results
The Company provides Fiscal 2025 second quarter financial results for its Gourmet Foods and Gift Baskets, Consumer Floral and Gifts, and BloomNet® segments in the tables attached to this release and as follows:
Gourmet Foods and Gift Baskets: Revenues for the quarter declined 4.0% to $518.5 million as compared with the prior year period. The Company estimates that the issues associated with the implementation of its new order management system resulted in lost revenue of approximately $20 million. Gross profit margin increased 30 basis points to 43.5%, benefiting from the Company’s inventory and labor optimization efforts that offset the incremental costs associated with the order management system issues. Excluding the impact of the systems implementation costs, adjusted segment contribution margin1 was $111.4 million, as compared with segment contribution margin1 of $118.2 million in the prior year period.
Consumer Floral & Gifts: Revenues for the quarter declined 8.0% to $234.3 million as compared with the prior year period. Gross profit margin decreased 90 basis points to 41.9%, primarily due to deleveraging on the sales decline and a promotional consumer environment. Segment contribution margin1 was $21.6 million, compared with adjusted segment contribution margin1 of $30.4 million in the prior year period, excluding the intangible impairment.
BloomNet: Revenues for the quarter declined 16.2% to $22.8 million as compared with the prior year period. Revenue and gross margin were impacted by the lower volume of lower margin orders processed by BloomNet. Gross profit margin increased 330 basis points to 50.9% due to lower florist rebates. Segment contribution margin1 was $7.5 million, compared with $9.1 million in the prior year period.
Company Guidance
Based on the Company’s performance during its fiscal second quarter, the Company is updating its Fiscal 2025 guidance as outlined below. The Company expects its revenue trends to improve as the fiscal year progresses, benefiting from its Relationship Innovation initiatives that have expanded the Company’s offerings, broadened price points and enhanced the user experience.
For Fiscal 2025, the company now expects:
total revenues to decline in the mid-single digits on a percentage basis, as compared with the prior year;
Adjusted EBITDA1 to be in a range of $65 million to $75 million; and
Free Cash Flow1 to be in a range of $25 million to $35 million.
Credit Agreement Amendment
The Company today announced that it has amended its credit agreement in order to provide more clarity and flexibility to the Company going forward.
Key changes effected by the amendment include revising the definition of Consolidated EBITDA, clarifying the application of optional term loan prepayments toward scheduled principal payments, and revising the definition of Consolidated Fixed Charges. Additional information can be found in the Company’s Form 8-K that was filed with the SEC this morning.
Conference Call
The Company will conduct a conference call to discuss the above details and attached financial results today, January 30, 2025, at 8:00 a.m. (ET). The conference call will be webcast from the Investors section of the Company’s website at www.1800flowersinc.com. A recording of the call will be posted on the Investors section of the Company’s website within two hours of the call’s completion. A telephonic replay of the call can be accessed beginning at 2:00 p.m. (ET) today through February 6, 2025, at: (US) 1-877-344-7529; (Canada) 855-669-9658; (International) 1-412-317-0088; enter conference ID #: 4981439.
Definitions of non-GAAP Financial Measures:
We sometimes use financial measures derived from consolidated financial information, but not presented in our financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). Certain of these are considered “non-GAAP financial measures” under the U.S. Securities and Exchange Commission rules. Non-GAAP financial measures referred to in this document are either labeled as “non-GAAP” or designated as such with a “1”. See below for definitions and the reasons why we use these non-GAAP financial measures. Where applicable, see the Selected Financial Information below for reconciliations of these non-GAAP measures to their most directly comparable GAAP financial measures. Reconciliations for forward-looking figures would require unreasonable efforts at this time because of the uncertainty and variability of the nature and amount of certain components of various necessary GAAP components, including, for example, those related to compensation, tax items, amortization or others that may arise during the year, and the Company’s management believes such reconciliations would imply a degree of precision that would be confusing or misleading to investors. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The lack of such reconciling information should be considered when assessing the impact of such disclosures.
EBITDA and Adjusted EBITDA:
We define EBITDA as net income (loss) before interest, taxes, depreciation, and amortization. Adjusted EBITDA is defined as EBITDA adjusted for the impact of stock-based compensation, Non-Qualified Deferred Compensation Plan (“NQDC”) Investment appreciation/depreciation, and for certain items affecting period-to-period comparability. See Selected Financial Information for details on how EBITDA and Adjusted EBITDA were calculated for each period presented. The Company presents EBITDA and Adjusted EBITDA because it considers such information meaningful supplemental measures of its performance and believes such information is frequently used by the investment community in the evaluation of similarly situated companies. The Company uses EBITDA and Adjusted EBITDA as factors to determine the total amount of incentive compensation available to be awarded to executive officers and other employees. The Company’s credit agreement uses EBITDA and Adjusted EBITDA to determine its interest rate and to measure compliance with certain covenants. EBITDA and Adjusted EBITDA are also used by the Company to evaluate and price potential acquisition candidates. EBITDA and Adjusted EBITDA have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of the Company’s results as reported under GAAP. Some of the limitations are: (a) EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, the Company’s working capital needs; (b) EBITDA and Adjusted EBITDA do not reflect the interest expense, or the cash requirements necessary to service interest or principal payments, on the Company’s debts; and (c) although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future and EBITDA does not reflect any cash requirements for such capital expenditures. EBITDA and Adjusted EBITDA should only be used on a supplemental basis combined with GAAP results when evaluating the Company’s performance.
Segment Contribution Margin and Adjusted Segment Contribution Margin
We define Segment Contribution Margin as earnings before interest, taxes, depreciation, and amortization, before the allocation of corporate overhead expenses. Adjusted Segment Contribution Margin is defined as Segment Contribution Margin adjusted for certain items affecting period-to-period comparability. See Selected Financial Information for details on how Segment Contribution Margin and Adjusted Segment Contribution Margin were calculated for each period presented. When viewed together with our GAAP results, we believe Segment Contribution Margin and Adjusted Segment Contribution Margin provide management and users of the financial statements meaningful information about the performance of our business segments. Segment Contribution Margin and Adjusted Segment Contribution Margin are used in addition to and in conjunction with results presented in accordance with GAAP and should not be relied upon to the exclusion of GAAP financial measures. The material limitation associated with the use of Segment Contribution Margin and Adjusted Segment Contribution Margin is that they are an incomplete measure of profitability as they do not include all operating expenses or non-operating income and expenses. Management compensates for this limitation when using these measures by looking at other GAAP measures, such as Operating Income and Net Income.
Adjusted Net Income (Loss) and Adjusted or Comparable Net Income (Loss) Per Common Share:
We define Adjusted Net Income (Loss) and Adjusted or Comparable Net Income (Loss) Per Common Share as Net Income (Loss) and Net Income (Loss) Per Common Share adjusted for certain items affecting period-to-period comparability. See Selected Financial Information below for details on how Adjusted Net Income (Loss) Per Common Share and Adjusted or Comparable Net Income (Loss) Per Common Share were calculated for each period presented. We believe that Adjusted Net Income (Loss) and Adjusted or Comparable Net Income (Loss) Per Common Share are meaningful measures because they increase the comparability of period-to-period results. Since these are not measures of performance calculated in accordance with GAAP, they should not be considered in isolation of, or as a substitute for, GAAP Net Income (Loss) and Net Income (Loss) Per Common Share, as indicators of operating performance and they may not be comparable to similarly titled measures employed by other companies.
Free Cash Flow:
We define Free Cash Flow as net cash provided by operating activities less capital expenditures. The Company considers Free Cash Flow to be a liquidity measure that provides useful information to management and investors about the amount of cash generated by the business after the purchases of fixed assets, which can then be used to, among other things, invest in the Company’s business, make strategic acquisitions, strengthen the balance sheet, and repurchase stock or retire debt. Free Cash Flow is a liquidity measure that is frequently used by the investment community in the evaluation of similarly situated companies. Since Free Cash Flow is not a measure of performance calculated in accordance with GAAP, it should not be considered in isolation or as a substitute for analysis of the Company’s results as reported under GAAP. A limitation of the utility of Free Cash Flow as a measure of financial performance is that it does not represent the total increase or decrease in the Company’s cash balance for the period.
About 1-800-FLOWERS.COM, Inc.
1-800-FLOWERS.COM, Inc. is a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships. The Company’s e-commerce business platform features an all-star family of brands, including: 1-800-Flowers.com®, 1-800-Baskets.com®, CardIsle®, Cheryl’s Cookies®, Harry & David®, PersonalizationMall.com®, Shari’s Berries®, FruitBouquets.com®, Things Remembered®, Moose Munch®, The Popcorn Factory®, Wolferman’s Bakery®, Vital Choice®, Simply Chocolate® and Scharffen Berger®. Through the Celebrations Passport® loyalty program, which provides members with free standard shipping and no service charge on eligible products across our portfolio of brands, 1-800-FLOWERS.COM, Inc. strives to deepen relationships with customers. The Company also operates BloomNet®, an international floral and gift industry service provider offering a broad-range of products and services designed to help members grow their businesses profitably; Napco℠, a resource for floral gifts and seasonal décor; DesignPac Gifts, LLC, a manufacturer of gift baskets and towers; Alice’s Table®, a lifestyle business offering fully digital livestreaming and on demand floral, culinary and other experiences to guests across the country; and Card Isle®, an e-commerce greeting card service. 1-800-FLOWERS.COM, Inc. was recognized among America’s Most Trustworthy Companies by Newsweek for 2024. 1-800-FLOWERS.COM, Inc. was also recognized as one of America’s Most Admired Workplaces for 2025 by Newsweek and was named to the Fortune 1000 list in 2022. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS. For more information, visit 1800flowersinc.com.
FLWS–COMP FLWS-FN
Special Note Regarding Forward Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company’s current expectations or beliefs concerning future events and can generally be identified using statements that include words such as “estimate,” “expects,” “project,” “believe,” “anticipate,” “intend,” “plan,” “foresee,” “forecast,” “likely,” “should,” “will,” “target” or similar words or phrases. These forward-looking statements are subject to risks, uncertainties, and other factors, many of which are outside of the Company’s control, which could cause actual results to differ materially from the results expressed or implied in the forward-looking statements, including, but not limited to, statements regarding the Company’s ability to achieve its guidance for the full Fiscal year; the Company’s ability to leverage its operating platform and reduce its operating expense ratio; its ability to successfully integrate acquired businesses and assets; its ability to successfully execute its strategic initiatives; its ability to cost effectively acquire and retain customers; the outcome of contingencies, including legal proceedings in the normal course of business; its ability to compete against existing and new competitors; its ability to manage expenses associated with sales and marketing and necessary general and administrative and technology investments; its ability to reduce promotional activities and achieve more efficient marketing programs; and general consumer sentiment and industry and economic conditions that may affect levels of discretionary customer purchases of the Company’s products. The Company undertakes no obligation to publicly update any of the forward-looking statements, whether because of new information, future events or otherwise, made in this release or in any of its SEC filings. Consequently, you should not consider any such list to be a complete set of all potential risks and uncertainties. For a more detailed description of these and other risk factors, refer to the Company’s SEC filings, including the Company’s Annual Reports on Form 10-K and its Quarterly Reports on Form 10-Q.
Note: The following tables are an integral part of this press release without which the information presented in this press release should be considered incomplete.
Addressing Critical U.S. Vulnerabilities in Vaccine Supply and National Preparedness
ATLANTA, GA, January 29, 2025 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, today highlighted that it is committed to playing a pivotal role in reinforcing America’s biosecurity through its GEO-MVA vaccine, designed to combat both smallpox and Mpox. In light of recent global health challenges, the United States has recognized the critical need to reduce dependence on foreign vaccine suppliers and bolster domestic production capabilities.
The 2022 Mpox pandemic significantly depleted the U.S. Strategic National Stockpile (SNS) of vaccines, exposing vulnerabilities in the nation’s preparedness for emerging health threats. Compounding this issue is the nation’s reliance on a single foreign manufacturer for smallpox and Mpox vaccines. This dependency poses a strategic risk, especially considering the current Clade I Mpox outbreak in Africa, characterized by an estimated 5%-10% mortality rate, increasingly migrating to other regions worldwide.
GeoVax’s GEO-MVA vaccine is expected to offer a timely and strategic solution. Developed on the proven Modified Vaccinia Ankara (MVA) platform, a clinical batch of GEO-MVA has recently been produced under current Good Manufacturing Practice (cGMP) production. Clinical evaluation of the vaccine is expected to begin this year. The Company’s innovative advanced MVA manufacturing process is anticipated to provide scalable, flexible and cost-effective vaccine production, reducing reliance on foreign vaccine manufacturers and reinforcing domestic biosecurity.
America First – Bolstering U.S. Biomanufacturing Resilience
The importance of onshoring medical product manufacturing has garnered bipartisan support among U.S. legislators. Reps. Earl L. “Buddy” Carter (R-GA), Elissa Slotkin (D-MI), Chrissy Houlahan (D-PA), and Gus Bilirakis (R-FL) officially launched the bipartisan Domestic Pharmaceutical Manufacturing Caucus for the 118th Congress. (https://buddycarter.house.gov/news/documentsingle.aspx?DocumentID=11059)
GeoVax’s commitment to domestic vaccine production aligns seamlessly with these national initiatives, positioning GEO-MVA as a cornerstone in America’s strategy to achieve vaccine independence and enhance public health preparedness.
David Dodd, GeoVax’s Chairman and CEO, stated, “With GEO-MVA, we intend to create the first U.S.-based source for a Mpox vaccine, an important biodefense goal.”
Recent Conference Presentations
GeoVax CEO David Dodd recently presented the Company’s strategic initiatives and the potential of GEO-MVA at:
GEO-MVA is a Mpox and smallpox vaccine candidate utilizing U.S. NIH rights acquired by GeoVax. Designed for robust immune responses, GEO-MVA is anticipated to offer a safe and effective solution for both immunocompromised and general populations.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned to initiate during the first half of 2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, 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.
TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) today announced that the Board of Directors of ARLP’s general partner approved a cash distribution to its unitholders for the quarter ended December 31, 2024 (the “2024 Quarter”).
ARLP unitholders of record as of the close of trading on February 7, 2025 will receive a cash distribution for the 2024 Quarter of $0.70 per unit (an annualized rate of $2.80 per unit), payable on February 14, 2025. The announced distribution is consistent with the cash distributions of $0.70 per unit for the quarters ended December 31, 2023 and September 30, 2024.
As previously announced, ARLP will report financial results for the 2024 Quarter before the market opens on Monday, February 3, 2025 and Alliance management will discuss these results during a conference call beginning at 10:00 a.m. Eastern that same day.
To participate in the conference call, dial (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at www.arlp.com.
An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13750955.
Concurrent with this announcement we are providing qualified notice to brokers and nominees that hold ARLP units on behalf of non-U.S. investors under Treasury Regulation Section 1.1446-4(b) and (d) and Treasury Regulation Section 1.1446(f)-4(c)(2)(iii). Brokers and nominees should treat one hundred percent (100%) of ARLP’s distributions to non-U.S. investors as being attributable to income that is effectively connected with a United States trade or business. In addition, brokers and nominees should treat one hundred percent (100%) of the distribution as being in excess of cumulative net income for purposes of determining the amount to withhold. Accordingly, ARLP’s distributions to non-U.S. investors are subject to federal income tax withholding at a rate equal to the highest applicable effective tax rate plus ten percent (10%). Nominees, and not ARLP, are treated as the withholding agents responsible for withholding on the distributions received by them on behalf of non-U.S. investors.
About Alliance Resource Partners, L.P.
ARLP is a diversified energy company that is currently the second largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.
News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.
Investor Relations Contact
Cary P. Marshall Senior Vice President and Chief Financial Officer 918-295-7673 investorrelations@arlp.com
Large pill size, high pill burden and palatability were identified as key barriers for phosphate binder adherence
LOS ALTOS, Calif., Jan. 28, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the publication of a review on patient perspectives regarding phosphate management in the peer-reviewed journal, Journal of Nephrological Science.
The publication, entitled “Patient Perspectives: The Effects of Contemporary Phosphorus Management on Quality of Life,” examines the challenges of phosphate management therapies from patients’ viewpoints, focusing on the limitations of current phosphate binders and their effect on patients’ quality of life. The publication underscores key findings from patient surveys and medical literature, identifying critical barriers to effective phosphorus management and emphasizing the need for patient-centered approaches to improve clinical outcomes and patient satisfaction.
“In therapeutic categories with significant patient non-adherence to standard of care like chronic kidney disease (CKD), it is essential to understand the factors disrupting medical intervention in order to offer physicians and patients innovative solutions,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “We believe products like Oxylanthanum Carbonate (OLC), which is characterized by small pill size, lower pill burden, and easy-to-swallow tablets, have the potential to address many of the inherent challenges in phosphorus management that often lead to nonadherence and poor serum phosphate control. If approved, we look forward to offering OLC to CKD patients on dialysis with hyperphosphatemia.”
Key Findings:
Hyperphosphatemia is linked to increased mortality risk.
Dialysis patients often face a high daily pill burden, with phosphate binders making up about 50% of the total.
Nonadherence to phosphate binders is a significant challenge contributing to elevated phosphate levels. Studies show non-adherence rates range from 22% to 74%, with a mean non-adherence rate of 51%.
Factors contributing to non-adherence include large pill size, high pill burden, and unpleasant gastrointestinal side effects. Social factors and timing complexities also impact adherence.
Engaging patients in discussions about different phosphate binders and their unique characteristics is key to improving adherence and satisfaction. New therapies that reduce pill size or burden while maintaining efficacy could enhance clinical outcomes, quality of life, and the patient-clinician relationship.
Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4
Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.
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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
1Reason Research, LLC 2022 survey. Results here. 2 Fortune Business Insights™, Hyperphosphatemia Treatment Market, 2023-2030 3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM 4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.
Process Expected to Increase Production Yield, Flexibility at Lower Cost
Atlanta, GA – January 27, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in vaccines and immunotherapies, has shared updates about its development-stage advanced Modified Vaccinia Ankara (MVA) vaccine manufacturing process. This anticipated process provides the potential to not only address today’s pressing health challenges but also paves the way for more efficient, flexible and lower-cost MVA-vaccine manufacturing.
The Power and Versatility of the MVA Platform
The MVA platform is uniquely designed to incorporate multiple antigens into a single vaccine. This versatility allows GeoVax to develop vaccines targeting multiple aspects of a single pathogen or several pathogens simultaneously. Originally developed as a safer smallpox vaccine, the MVA platform offers distinct advantages, including:
Protection against diseases such as Mpox and smallpox.
Multi-antigen vaccines like GEO-CM04S1, which targets both the Spike (S) and Nucleocapsid (N) antigens of SARS-CoV-2.
Stability under minimal refrigeration and the potential for freeze-drying (lyophilization), simplifying distribution in resource-limited settings.
Advancing MVA Manufacturing
Current vaccine manufacturing methods rely on Chicken Embryo Fibroblast (CEF) cells, requiring pathogen-free eggs. This process is costly, time-consuming, and dependent on limited egg supplies, providing barriers to rapid, real-time MVA manufacturing, as well as hindering the flexibility necessary to establish local MVA manufacturing of critically important vaccines. GeoVax is addressing these barriers through an advanced MVA Manufacturing process utilizing an avian cell line licensed from ProBioGen AG (Berlin). Key features include:
A continuous avian suspension cell line process that eliminates the need for pathogen-free eggs.
Compatibility with standard manufacturing equipment, reducing setup time, simplifying the MVA manufacturing process, increasing scalability and lowering manufacturing costs.
This advanced MVA manufacturing process is expected to significantly simplify vaccine production, particularly in middle- and low-income regions where supply chain issues often hinder access to critical vaccines.
Addressing Global Health Needs
“Our advanced MVA manufacturing process represents not only a transformative manufacturing advance but also addresses a public health imperative,” said David Dodd, Chairman and CEO of GeoVax. “By tackling disease protection, logistical hurdles, and manufacturing challenges, we aim to empower regions like Africa with the tools needed to combat current and future health crises.”
GeoVax’s MVA vaccines have demonstrated robust performance in clinical trials, with ongoing Phase 2 studies for GEO-CM04S1, its COVID-19 vaccine candidate, showing broad and durable immune responses. Supported by its BARDA Project NextGen Award and partnerships with leading manufacturing and development organizations, GeoVax is positioned to enhance vaccine access and delivery on a global scale.
Recent Conference Presentations
GeoVax CEO David Dodd recently presented the company’s strategic initiatives and the potential of GEO-MVA at:
Biotech Showcase: January 14, 2025
Emerging Growth Conference: January 16, 2025
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned to initiate in mid-2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, 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.
OCU500 will be administered via inhalation and as a nasal spray
COVID-19 remains a substantial public health threat in the U.S. and around the world
Phase 1 clinical trial is anticipated to start in 2Q 2025
MALVERN, Pa., Jan. 27, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has reviewed the Company’s Investigational New Drug (IND) application and it is in effect. This is a critical step toward the initiation of the Phase 1 clinical trial for OCU500—an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will sponsor and conduct the Phase 1 trial to assess the safety, tolerability, and immunogenicity of OCU500 administered via two different routes, inhalation into the lungs and intranasally as a spray.
“We are grateful for our ongoing collaboration with NIAID and pleased to bring our novel vaccine technology into the clinic through Project NextGen,” said Mike Shine, Senior Vice President, Commercial at Ocugen. “COVID-19 remains a real public health concern, and an increasing number of studies are showing the benefit of mucosal vaccines that attack the virus where it enters the body—through the nose and mouth—to give better and longer protection. We look forward to this important next step in potentially providing a more durable and safer option to help prevent infection and transmission of COVID-19 regarding various variants of concern.”
Even though the pandemic has ended, COVID-19 still presents a significant burden in the U.S. The Centers for Disease Control (CDC) estimates that from October 1, 2024 to January 11, 2025, there were 4.4 to 7.9 million COVID infections, resulting in 120,000 to 210,000 hospitalizations and 14,000 to 25,000 deaths.
The Phase 1 trial would enroll 80 adult subjects aged 18 to 64 years. Forty (40) subjects would be assigned to the low-dose group, and 40 subjects would be assigned to the high-dose group. Within each group, 20 subjects would receive the inhalation form of the vaccine, and the other 20 subjects would receive the intranasal form. The primary aim of the study would be to determine safety, while secondary and exploratory endpoints include antibody production and the number of breakthrough COVID-19 infections.
OCU500 is based on a novel chimpanzee adenovirus-vectored (ChAd36) technology. Earlier clinical studies to prevent COVID-19 that employed a similar technology administered via inhalation demonstrated increased mucosal and systemic antibodies and a durable immune response up to one year using one-fifth the dose compared to the same vaccine administered intramuscularly. Ocugen intends to expand this mucosal platform to address other serious respiratory threats including seasonal influenza, bird flu, and respiratory syncytial virus (RSV).
The original ChAd36 vector that makes the Ocugen vaccine unique was licensed from Washington University in St. Louis.
“We are delighted to see the progress of the ChAd36 vector encoding a SARS-CoV-2 spike antigen that was originally designed and tested at Washington University in St. Louis,” said Dr. Michael Diamond, Professor of Medicine and Co-Director of the Center for Vaccines and Immunity to Microbial Pathogens at Washington University School of Medicine. “We believe this vector is ideal for mucosal administration and can be designed to carry COVID-19 strains as well as influenza and antigens from other respiratory viruses,” added Dr. David Curiel, Professor of Radiation Oncology, Washington University School of Medicine, co-collaborator on the vector design.
Project NextGen is a $5 billion multi-government agency initiative to develop the next generation of vaccines and therapeutics to combat the spread of COVID-19. NIAID, with funding from Project NextGen, will cover the full cost of the Phase 1 clinical trial, including operations and related analysis. Ocugen is providing clinical trial materials and, upon completion, will have full right of reference to the findings, which Ocugen believes will provide clinical evidence to support the further development of the Company’s lead mucosal vaccine candidate.
“Ocugen further advanced the vector technology, enabling the incorporation of single/multiple antigens into a single vector. This innovation offers significant manufacturing flexibility in responding to emerging variants within one hundred days of identifying a circulating variant of concern,” said Dr. Arun Upadhyay, Chief Scientific Officer at Ocugen. “This vector technology, combined with mucosal delivery, has the potential to enable rapid development of respiratory vaccines in response to future outbreaks including bird flu.”
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including,butnotlimitedto,therisksthatpreliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;the ability of OCU500 to perform in humans in a manner consistent with nonclinical or preclinical study data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingofmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subject to differing interpretations and assessments, including by regulatory authorities.Theseandotherrisksanduncertaintiesaremorefully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
Purchase, NY – January 27, 2025 – Townsquare Media, Inc. (NYSE: TSQ), a leader in digital advertising and marketing solutions focused on markets outside of the Top 50 in the United States, announced today a strategic digital advertising partnership with Steel City Media, a multi-media company with market-leading media outlets in Pittsburgh and Kansas City. Townsquare teased this partnership in the pre-release of their estimated 2024 financial results last week.
“We could not be more excited to have the talented team at Steel City Media join our partnership program. They will now be able to leverage Townsquare Ignite’s cutting-edge digital advertising and marketing solutions to their expansive customer base, which importantly exists in markets that do not compete with ours,” said Todd Lawley, President of Townsquare Ignite, the Company’s Digital Advertising division. “Our expertise is coaching and training high performing broadcast sales teams to leverage our proprietary programmatic advertising platform and data-driven insights to deliver exceptional results for their clients. By sharing our proven strategies and dynamic approach, we look forward to helping Steel City strengthen their digital capabilities, driving growth and measurable success for their clients.”
Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for SMBs; a robust digital advertising division, Townsquare IGNITE, a powerful combination of a) an owned and operated portfolio of more than 400 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 345 local terrestrial radio stations in 74 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com and NJ101.5.com, and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com, and Loudwire.com. For more information, please visit www.townsquaremedia.com, www.townsquareinteractive.com, and www.townsquareignite.com.
Brendan Hoffman Expected to Become CEO of Vince Holding Corp.
NEW YORK–(BUSINESS WIRE)– Vince Holding Corp., (NYSE: VNCE) (“VNCE” or the “Company”), a global contemporary retailer, today announced that P180, a new venture focused on accelerating growth and profitability in the luxury apparel sector, acquired a majority stake in VNCE (the “P180 Acquisition”) from affiliates of Sun Capital Partners, Inc. (collectively, “Sun Capital”).
In conjunction with the P180 Acquisition, Brendan Hoffman is expected to assume the role of Chief Executive Officer of VNCE effective on or around February 3, 2025, subject to finalization of his employment terms. With this transition, David Stefko is expected to step down as Interim CEO of VNCE and continue to serve on the VNCE Board of Directors. In addition, Matthew Garff resigned from the VNCE Board of Directors in connection with the P180 Acquisition.
“VNCE is the perfect partner for P180; the brand’s dominance in the luxury contemporary market aligns seamlessly with our acquisition strategy. In addition, as VNCE has evolved its operating model, we believe having access to the technology and team of CaaStle, founded by Christine Hunsicker, my co-founder at P180, will further advance the company’s momentum in driving improved profitability while enhancing its omni-channel experience.” Mr. Hoffman added, “Personally, I have a strong connection to the Vince brand, having served as VNCE CEO for five years. I am excited to lead the team again as we continue to unlock new growth opportunities, drive innovation, enhance the brand’s market position, and focus on monetizing the Company’s inventory to ensure continued long-term success.”
“P180’s acquisition represents a transformative opportunity for VNCE. With this transaction, we will gain the operational expertise and cutting-edge digital capabilities needed to drive the brand’s future success,” commented Michael Mardy, Chairman of VNCE. “On behalf of the Board and the organization, I would also like to thank Dave for stepping into the interim CEO role for the past year. Through his leadership, the company has continued to execute and deliver results by operating a healthier full price model. We are glad to have Dave remain on the Board and are excited to welcome Brendan back to lead the organization into its next chapter.”
This acquisition marks the third strategic deal for P180 since its inception in 2024 and follows its recent investment with the prestigious fashion label Altuzarra and digital partnership with the multi-brand premium retailer elysewalker.
VNCE Significantly Reduces Debt
Simultaneously with the P180 Acquisition, an indirectly wholly owned subsidiary of VNCE, V Opco, LLC (“V Opco”), amended its existing credit agreement (the “ABL Credit Facility”) with Bank of America, N.A. (“BofA”). The amendment consents to, among other things, the change in control in connection with the P180 Acquisition, as well as a partial pay down of the subordinated debt (“Sun Debt Facility”) with SK Financial Services, LLC, an affiliate of Sun Capital, through increased borrowings under the ABL Credit Facility. On the same day, V Opco paid $15 million to SK Financial Services, LLC using proceeds from the ABL Credit Facility, which resulted in a pay-down of $20 million under the Sun Debt Facility (the “Sun Debt Paydown”).
In addition, P-180 acquired and assumed $7 million of the loans (the “P-180 Assumed Loan”) outstanding pursuant to the Sun Debt Facility and immediately thereafter cancelled such $7 million (the “P-180 Debt Forgiveness”).
Following the Sun Debt Paydown and P-180 Debt Forgiveness, the outstanding principal amount of subordinated loans is reduced by approximately $27 million with $7.5 million remaining outstanding under the Sun Debt Facility, which will continue to accrue payment-in-kind interest in accordance with, and otherwise be subject to, the terms and conditions therein.
Immediately following the P-180 Acquisition, P180 beneficially owned approximately 65% of all outstanding shares of common stock of VNCE and affiliates of Sun Capital continue to beneficially own approximately 2% of the Company’s outstanding common stock.
As part of the terms to the transactions described above, P-180 agreed to reimburse the Company for certain fees and expenses incurred in connection with such transactions, including the Company’s legal fees as well as the consent fee to BofA.
About P180:
P180, a new venture co-founded by Christine Hunsicker (founder and CEO of CaaStle, Inc.) and Brendan Hoffman, is dedicated to driving brand and retailer profitability by providing operational expertise and access to leading industry resources, including CaaStle’s innovative monetization platform. P180’s core mission is to invest in or acquire brands and retailers that stand to benefit from digital expertise and inventory monetization.
About VNCE:
Vince Holding Corp. is a global retail company that operates the Vince brand women’s and men’s ready to wear business. Vince, established in 2002, is a leading global luxury apparel and accessories brand best known for creating elevated yet understated pieces for every day effortless style. Vince Holding Corp. operates 47 full-price retail stores, 14 outlet stores, and its e-commerce site, vince.com and through its subscription service Vince Unfold, www.vinceunfold.com, operated by CaaStle, as well as through premium wholesale channels globally. Please visit www.vince.com for more information.
Forward-Looking Statements: This document contains forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding, among other things, our planned transformation program and our current expectations about possible or assumed future results of operations of the Company and are indicated by words or phrases such as “may,” “will,” “should,” “believe,” “expect,” “seek,” “anticipate,” “intend,” “estimate,” “plan,” “target,” “project,” “forecast,” “envision” and other similar phrases. Although we believe the assumptions and expectations reflected in these forward-looking statements are reasonable, these assumptions and expectations may not prove to be correct and we may not achieve the results or benefits anticipated. These forward-looking statements are not guarantees of actual results, and our actual results may differ materially from those suggested in the forward-looking statements. These forward-looking statements involve a number of risks and uncertainties, some of which are beyond our control, including, without limitation: our ability to successfully manage the transition of VNCE majority ownership to P180 and to execute P180’s strategies for the Company; our ability to execute and realize the enhanced profitability expectations of our planned transformation program; our ability to maintain the license agreement with ABG Vince, a subsidiary of Authentic Brands Group; ABG Vince’s expansion of the Vince brand into other categories and territories; ABG Vince’s approval rights and other actions; our ability to maintain adequate cash flow from operations or availability under our revolving credit facility to meet our liquidity needs; our ability to realize the benefits of our strategic initiatives; general economic conditions; further impairment of our goodwill; the execution and management of our direct-to-consumer business growth plans; our ability to make lease payments when due; our ability to maintain our larger wholesale partners; our ability to remediate the identified material weakness in our internal control over financial reporting; our ability to comply with domestic and international laws, regulations and orders; our ability to anticipate and/or react to changes in customer demand and attract new customers, including in connection with making inventory commitments; our ability to remain competitive in the areas of merchandise quality, price, breadth of selection and customer service; our ability to attract and retain key personnel; seasonal and quarterly variations in our revenue and income; our ability to mitigate system security risk issues, such as cyber or malware attacks, as well as other major system failures; our ability to optimize our systems, processes and functions; our ability to comply with privacy-related obligations; our ability to ensure the proper operation of the distribution facilities by third-party logistics providers; fluctuations in the price, availability and quality of raw materials; commodity, raw material and other cost increases; the extent of our foreign sourcing; our reliance on independent manufacturers; other tax matters; and other factors as set forth from time to time in our Securities and Exchange Commission filings, including those described under “Item 1A—Risk Factors” in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We intend these forward-looking statements to speak only as of the time of this release and do not undertake to update or revise them as more information becomes available, except as required by law.
RICHMOND, Va.–(BUSINESS WIRE)– Lucky Strike Entertainment (NYSE: LUCK), one of the world’s premier operators of location-based entertainment, will report financial results for the second quarter of fiscal 2025 on Wednesday, February 5, 2025, before the U.S. stock market opens. Management will discuss the results via webcast at 10:00 AM ET on the same day.
The live webcast, replay, and results presentation will be available in the Events & Presentations section of the Lucky Strike Entertainment Investor Relations website at IR.LuckyStrikeEnt.com.
About Lucky Strike Entertainment
Lucky Strike Entertainment is one of the world’s premier location-based entertainment platforms. With over 360 locations across North America, Lucky Strike Entertainment provides experiential offerings in bowling, amusements, water parks, and family entertainment centers. The company also owns the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Lucky Strike Entertainment, please visit IR.LuckyStrikeEnt.com.
Vancouver, British Columbia–(Newsfile Corp. – January 22, 2025) – Maple Gold Mines Ltd. (TSXV: MGM) (OTCQB: MGMLF) (FSE: M3G) (“Maple Gold” or the “Company“) is pleased to provide an exploration update and 2025 outlook for its 100%-owned Douay Gold Project (“Douay“) and Joutel Gold Project (“Joutel“) (together, “Douay/Joutel” or the “Property“) located along the Casa Berardi-Douay Gold Trend in Québec, Canada (see Figures 1 and 2).
A 10,000-metre (“m“) Phase I diamond drilling program (the “Program“) has now commenced at Douay with an expected duration of three to four months. The location of the Douay mineralized zones and primary targets are shown in Figures 3 and 4. Key objectives of the Program include:
Targeting poorly drilled areas within Inferred Resources for conversion to Indicated Resources within the pit-constrained and underground resource domains;
Step-out drilling along strike, down-dip, and down-plunge to expand Inferred Resources
Step-out drilling from zones of high-grade gold mineralization within the underground Inferred Resources to demonstrate lateral and vertical continuity;
Targeting areas between modeled mineralized zones with geological continuity; and
Testing new targets developed during the compilation exercise of geological, geochemical and geophysical data.
Concurrent development initiatives are anticipated throughout 2025 to advance and de-risk the Douay deposit, including a review of the current Douay mineral resource estimate (“MRE“) and an evaluation of potential scenarios to optimize higher grade mineral resources that could be accessible via underground mining methods. An additional 3,000 m of diamond drilling is planned at Joutel in H2 2025 to extend the known high-grade gold mineralization along the past-producing Eagle-Telbel mine trend.
“We are excited to be drilling again at Douay with refocused attention on the higher-grade core of the deposit and its possible extensions both within and beyond our current drill pattern up to 500 m vertical depth,” stated Kiran Patankar, President and CEO. “Maple Gold’s technical team has accomplished a monumental task in compiling over 50 years of exploration data to generate new geological/structural/geochemical 3D models that have vastly improved our drill targeting. This work highlights the excellent exploration potential of Douay/Joutel, the importance of its location along the deep-seated Casa Berardi break, and the opportunity for the Property to host multiple gold deposits within a variety of geological settings. Our focus in 2025 will be executing a comprehensive exploration and development program that is aimed at delivering shareholder value through the drill bit and via project de-risking, while maintaining strict cost discipline across the Company.”
A total exploration budget of approximately $6.3 million has been established for 2025, including permitting, drilling, assaying, personnel, camp and site support costs. The 2025 work program will be fully funded from Maple Gold’s existing treasury.
Program Details
The Company is currently planning a minimum of 10,000 m of diamond drilling at Douay in 2025. Phase I drilling has now commenced with an expected duration of approximately three to four months (see Figures 3 and 4). The breakdown of the drilling metreage will be approximately: 70% dedicated to de-risking and expanding the Douay MRE through strategic infill and step-out holes (along strike and at depth); and 30% for the testing of new regional geological and geophysical targets along strike from the Douay MRE and north into the Taibi Group sediments along favourable structural breaks and lithologic contacts. The Company plans to complete infill drilling throughout the Douay MRE to convert Inferred Resources to Indicated Resources, potentially add new Inferred Resources within poorly drilled 100-200 m gaps between modeled mineral domains and target the down-plunge extensions of higher-grade zones outside the Douay MRE.
The Company plans to utilize all available data from its year-long data compilation exercise to initially target the shallow portions of the Douay mineralizing system (<500 m vertical depth) to fully understand the geometry of the known zones and outline key plunge directions (Phase I on Figure 4) before systematically stepping down-plunge and at depth (>500 m vertical depth) during a proposed second drilling phase (Phase II on Figure 4). This will allow the Company to control exploration risk and maximize exploration success.
The initial focus of Phase I drilling will be on the central portions of the Douay MRE targeting higher grade areas within the Porphyry Zone (comprised of West/Central/East portions), which is hosted within the Douay Intrusive Complex and includes some of the highest-grade assays returned on the Property (up to 2,888 grams/tonne (“g/t”) of gold (“Au”) over 0.5 m in historical drill hole DO-05-04). Other targets include: the 531 Zone which is hosted within mafic volcanic and folded interflow sedimentary rocks and includes one of highest-grade gold intersections reported by the Company in drill hole DO-21-310 which returned 8.8 g/t Au over 28.5 m, including 12.7 g/t Au over 10.0 m and 31.1 g/t Au over 0.5 m (see Company news release dated September 9, 2021); and the Main Zone which lies along the northern edge of the Douay Deformation Zone (“DDZ“) with gold mineralization hosted along the sheared graphitic contact between the Taibi Group volcaniclastic and sedimentary rocks to the north and Cartwright Hills Group mafic volcanic rocks to the south. Taibi Group sediments represent a promising new target area for the Company with the potential for sediment-hosted gold deposits along a major lithotectonic boundary similar to the Casa Berardi and Canadian Malartic deposits.
Douay/Joutel Exploration Update
Since the completion of its last drilling campaign in Spring 2023, the Company has focused on streamlining onsite operations, standardizing procedures, enhancing efficiencies, centralizing data management, optimizing workflow, and reducing overhead site costs. This effort has led to increased productivity from a revamped technical team that has reviewed historical drill core, compiled and digitized data, distinguished new geological and structural controls on gold mineralization, and developed vectors for targeting gold mineralization in the next phases of drilling.
Key tasks completed by the Maple Gold technical team include: re-logging of historical diamond drill core (>20,000 m); re-interpretation and preparation of drill hole cross-sections and level plans for all mineralized zones; updating and creating new robust 3D geological and structural models in Leapfrog software; updating of the Property-wide drill hole and geochemical databases with previously unincorporated historical data; layering of geological, structural, geochemical and geophysical data sets to generate new targets; and use of expert geochemical consultants to process multi-element assay data to identify potential pathfinder elements and ‘hot’ spots.
Key findings from the year-long data review and compilation exercise include:
The Casa Berardi Deformation Zone (the “CBDZ“) widens around Douay/Joutel resulting in complex zones along the DDZ of brittle and ductile deformation, subsidiary splays, NNE cross-faulting, and potential dextral rotation around the Douay Intrusive Complex resulting in Delta-type pressure shadows and possible structural traps for gold (see Figure 2).
A variety of host domains and rock types are favourable for gold mineralization including the Douay Alkaline Intrusion, Taibi Group sediments (including iron formations), Cartwright Hills Group basalts (including Fe-Rich tholeiitic komatiites), Temiskaming-style conglomerates, and structural breaks associated with major lithotectonic (volcanic-sedimentary) contacts.
Multiple styles and generations of mineralization are present at Douay/Joutel including Intrusion-Related Gold Systems (“IRGS“), multi-phase breccias, late orogenic gold, and synvolcanic-exhalative gold (Eagle-Telbel).
Gold mineralization is commonly associated with broad zones of albitization, Fe-carbonatization, silicification, hematization, fenitization, biotitization, and pyritization and alteration can be used as a key vector for gold mineralization.
The twelve (12) main mineralized zones all display a strong plunge geometry to the higher-grade gold mineralization, which varies from shallow to steep, and from southeast to southwest, possibly related to an earlier folding event. There also appears be a periodicity to the mineralized zones within the DDZ spaced 500 m to 1,000 m apart (see Figure 3).
There has been very limited drilling below 500 m vertical depth in comparison to other gold deposits in the Abitibi (East Gouldie/Odyssey, LaRonde) (see Figure 4).
Planned Douay Development Initiatives
The Company plans to review the current Douay MRE for the Project which currently contains both pit-constrained and underground Inferred and Indicated mineral resources to optimize higher grade resources that could be accessible via an underground mining scenario. Initial focus would include the Douay West zone which currently hosts Indicated mineral resources totaling 4.2 million tonnes (“Mt“) grading 2.13 g/t Au (containing 286,000 ounces of Au) and Inferred mineral resources totaling 3.7 Mt grading 1.39 g/t Au (containing 169,000 ounces of Au)1. Douay West also includes existing surface infrastructure constructed in 1995 including a headframe and mine hoist.
Figure 1: Location of the Douay/Joutel (Eagle-Telbel) Property in the Abitibi Sub-Province, Québec
Figure 4: Composite longitudinal section showing location of Douay Mineralized Zones and 2025 Target Areas (in red) (note: comparison to other deposits for reference purposes only)
2024 Exploration Work Completed at Joutel and Morris VMS Project
In Q2 2024, the Company completed a 525 line-km airborne drone-magnetic geophysical survey over a detailed grid on the western portion of the Joutel gold project to assist in the development of new drill targets along the western strike extent of the Eagle-Telbel stratigraphy.
In Q3 2024, the Company completed a lithogeochemical sampling program over its Morris volcanogenic massive sulphide (“VMS“) project, located 29 km east of Matagami, Québec. The program focused on the felsic volcanic rocks of the key Watson Lake formation which is present on the Morris project and is known to host the major VMS deposits within the Matagami mining camp. The Summer 2024 sampling program highlighted several areas of highly altered rhyolite, and the Company is developing plans for follow-up work in 2025.
Qualified Person
Ian Cunningham-Dunlop, P.Eng., Vice President, Technical Services of Maple Gold and a qualified person (“QP“) as defined by Canadian National Instrument 43-101, has reviewed and approved the scientific and technical information related to exploration and Mineral Resource matters contained in this news release.
About the Douay/Joutel Gold Project
The Douay/Joutel Gold Project is located adjacent to Highway 109 in the heart of the Abitibi greenstone belt, Canada’s premier gold mining jurisdiction (see Figure 1). This large, 100%-owned land package includes the multi-million ounce2 Douay Gold Project and the past-producing, high-grade Joutel Gold Mine Complex3. The Property contains ~400 km2 of highly prospective geology (see Figure 2) within the influence of the major gold-bearing CDBZ. Gold mines in the immediate region include the Casa Berardi Gold Mine operated by Hecla Mining Company and the Detour Lake Gold Mine operated by Agnico Eagle Mines Ltd. (see Figure 1).
About Maple Gold
Maple Gold Mines Ltd. is a Canadian advanced exploration company focused on advancing its 100%-owned, district-scale Douay and Joutel gold projects located in Québec’s prolific Abitibi Greenstone Gold Belt. The Douay/Joutel projects benefit from exceptional infrastructure access and boast ~400 km2 of highly prospective ground including an established gold mineral resource at Douay with significant expansion potential as well as the past-producing Telbel and Eagle West mines at Joutel. In addition, the Company holds an exclusive option to acquire 100% of the Eagle Mine Property, a key part of the historical Joutel Mining Complex.
Maple Gold’s property package also hosts a significant number of regional exploration targets along a 55-km strike length of the Casa Berardi Deformation Zone that have yet to be tested through drilling, making the property ripe for new gold and polymetallic discoveries. The Company is currently focused on carrying out exploration and drill programs to grow mineral resources and make new discoveries to establish an exciting new gold district in the heart of the Abitibi. For more information, please visit www.maplegoldmines.com.
NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS PRESS RELEASE.
Forward-Looking Statements and Cautionary Notes:
This news release contains “forward-looking information” and “forward-looking statements” (collectively referred to as “forward-looking statements”) within the meaning of applicable Canadian securities legislation in Canada. Forward-looking statements are statements that are not historical facts; they are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “aims,” “potential,” “goal,” “objective,”, “strategy”, “prospective,” and similar expressions, or that events or conditions “will,” “would,” “may,” “can,” “could” or “should” occur, or are those statements, which, by their nature, refer to future events. Forward-looking statements in this news release include, but are not limited to, statements about the resource expansion and discovery potential across the Company’s gold projects, and its intention to pursue such potential, and the Company’s exploration work and results from current and future work programs. Although the Company believes that forward-looking statements in this news release are reasonable, it can give no assurance that such expectations will prove to be correct, as forward-looking statements are based on assumptions, uncertainties and management’s best estimate of future events on the date the statements are made and involve a number of risks and uncertainties. Consequently, actual events or results could differ materially from the Company’s expectations and projections, and readers are cautioned not to place undue reliance on forward-looking statements. For a more detailed discussion of additional risks and other factors that could cause actual results to differ materially from those expressed or implied by forward-looking statements in this news release, please refer to the Company’s filings with Canadian securities regulators available on the System for Electronic Document Analysis and Retrieval Plus (SEDAR+) at www.sedarplus.ca or the Company’s website at www.maplegoldmines.com. Except to the extent required by applicable securities laws and/or the policies of the TSX Venture Exchange, the Company undertakes no obligation to, and expressly disclaims any intention to, update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
________________________ 1 For additional details, see the technical report for the Douay gold project entitled “Technical Report on the Douay and Joutel Projects Northwestern Québec, Canada Report for NI 43-101” prepared by SLR Consulting (Canada) Ltd. with an effective date of March 17, 2022, and dated April 29, 2022. 2 The Douay Project contains Indicated Mineral Resources estimated at 10 million tonnes at a grade of 1.59 g/t Au (containing 511,000 ounces of gold), and Inferred Mineral Resources estimated at 76.7 million tonnes at a grade of 1.02 g/t Au (containing 2,527,000 ounces of gold). See the technical report for the Douay Gold Project entitled “Technical Report on the Douay and Joutel Projects Northwestern Québec, Canada Report for NI 43-101″ prepared by SLR Consulting (Canada) Ltd. with an effective date of March 17, 2022, and dated April 29, 2022. 3 The Eagle, Eagle West and Telbel Gold Mines at Joutel were in production from 1974 to 1993 and produced 1.1 million ounces of gold at an average grade of 6.5 g/t Au (Agnico Eagle Mines Ltd. website)
PURCHASE, N.Y., Jan. 21, 2025 (GLOBE NEWSWIRE) — Townsquare Media, Inc. (NYSE: TSQ) (“Townsquare”, the “Company,” “we,” “us,” or “our”) announced today preliminary estimated financial results for the fourth quarter and full year ended December 31, 2024.
“We are pleased to pre-announce our fourth quarter and full year 2024 estimated results that are directly in-line with the expectations and guidance we had previously outlined on our third quarter earnings call. We expect full year net revenue will be between $450 million and $452 million, within our guidance range of $448 million to $452 million. Therefore, we expect fourth quarter net revenue will be between $117 million and $119 million. In addition, we expect full year 2024 Adjusted EBITDA will be approximately $100 million, within our guidance range of $100 million to $101 million. Therefore, we expect fourth quarter Adjusted EBITDA will be approximately $31 million,” commented Bill Wilson, Chief Executive Officer of Townsquare Media, Inc. “As anticipated, our digital divisions had a very strong fourth quarter, as Townsquare Interactive returned to year-over-year revenue growth, and Digital Advertising net revenue accelerated to year-over-year growth rates in excess of +15%, helped by national digital advertising returning to revenue growth together with ongoing strength in our digital programmatic business. In total, we expect fourth quarter Digital revenue to increase approximately +11% year-over-year, and represent 52% of Townsquare’s net revenue in 2024, a true point of differentiation from others in local media, as we have evolved from a local broadcast radio company that was founded in 2010, to a Digital First Local Media Company with a world class team and a unique and differentiated strategy, assets, platforms and solutions. Further, we could not be more pleased to share that we are continuing to expand our Media Partnerships division, whereby we provide a white-label service that equips other local media companies with the digital advertising solutions that have driven Townsquare’s success. Following our October 2024 announcement that we partnered with SummitMedia, who operates in nine markets that do not overlap with Townsquare’s footprint, we have recently entered an agreement with another local media provider who operates in two additional non-overlapping markets. We expect that partnership to launch this summer.”
Mr. Wilson continued, “Given the cash generative nature of our business and our strong cash position, we were able to repurchase and retire approximately $12 million of our Senior Secured Notes in the fourth quarter (and $36 million in total in 2024), ending the year with $467 million of debt and $33 million of cash on hand. The combination of our healthy balance sheet, ongoing digital strength and momentum, Digital First Local Media strategy, and focus on markets outside of the Top 50 U.S. cities, reinvigorates my confidence in our business model and our path to long-term, sustainable growth and success.”
The information presented herein is based on internally available financial information that has not been audited or subject to regular period end closing procedures. As such, the financial guidance presented above reflects various assumptions and estimates based only upon information available to management as of the date hereof. This information should not be viewed as a substitute for full audited financial statements prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). As a result, while this information is presented with ranges and approximations that management considers to be reasonable, it remains in all cases subject to change pending finalization. It is very difficult to predict the impact of known factors and it is impossible for the Company to anticipate all factors that could affect its actual results. Actual results may differ materially from the estimates presented above due to developments or other information that may arise between now and the time the financial results for the fourth quarter and fiscal year are finalized. Therefore, you should not place undue reliance on estimated financial information provided herein, which speaks only as of the date hereof. Estimates of results are inherently uncertain and subject to change, and the Company does not undertake any obligation to update this information. The Company’s independent registered public accounting firm, BDO USA, P.C., has not audited, reviewed, compiled or performed any procedures with respect to any of the estimated financial information. Accordingly, BDO USA, P.C. does not express an opinion or any other form of assurance with respect thereto. The preliminary estimated financial information for the quarter and year ended December 31, 2024 is not necessarily indicative of the results to be achieved in any future period.
About Townsquare Media, Inc.
Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for SMBs; a robust digital advertising division, Townsquare Ignite, a powerful combination of a) an owned and operated portfolio of more than 400 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 345 local terrestrial radio stations in 74 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com and NJ101.5.com, and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com, and Loudwire.com. For more information, please visit www.townsquaremedia.com, www.townsquareinteractive.com and www.townsquareignite.com.
Forward-Looking Statements Except for the historical information contained in this press release, the matters addressed are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements often discuss our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “aim,” “anticipate,” “estimate,” “expect,” “forecast,” “outlook,” “potential,” “project,” “projection,” “plan,” “intend,” “seek,” “believe,” “may,” “could,” “would,” “will,” “should,” “can,” “can have,” “likely,” the negatives thereof and other words and terms. Actual events or results may differ materially from the results anticipated in these forward-looking statements as a result of a variety of factors. While it is impossible to identify all such factors, factors that could cause actual results to differ materially from those estimated by us include the impact of general economic conditions in the United States, or in the specific markets in which we currently do business including supply chain disruptions, inflation, labor shortages and the effect on advertising activity, industry conditions, including existing competition and future competitive technologies, the popularity of radio as a broadcasting and advertising medium, cancellations, disruptions or postponements of advertising schedules in response to national or world events, our ability to develop and maintain digital technologies and hire and retain technical and sales talent, our dependence on key personnel, our capital expenditure requirements, our continued ability to identify suitable acquisition targets, and consummate and integrate any future acquisitions, legislative or regulatory requirements, risks and uncertainties relating to our leverage and changes in interest rates, our ability to obtain financing at times, in amounts and at rates considered appropriate by us, our ability to access the capital markets as and when needed and on terms that we consider favorable to us and other factors discussed in “Risk Factors” and “Forward-Looking Statements” in our 2023 Annual Report on Form 10-K, for the year ended December 31, 2023, filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2024, as well as other risks discussed from time to time in our filings with the SEC. Many of these factors are beyond our ability to predict or control. In addition, as a result of these and other factors, our past financial performance should not be relied on as an indication of future performance. The cautionary statements referred to in this section also should be considered in connection with any subsequent written or oral forward-looking statements that may be issued by us or persons acting on our behalf. The forward-looking statements included in this press release are made only as of the date hereof or as of the date specified herein. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Non-GAAP Financial Measures and Definitions In this press release, we refer to Adjusted EBITDA, which is a financial measure that has not been prepared in accordance with GAAP.
We define Adjusted EBITDA as net income before the deduction of income taxes, interest expense, net, gain on repurchases of debt, transaction and business realignment costs, depreciation and amortization, stock-based compensation, impairments, net loss (gain) on sale and retirement of assets and other expense (income) net. This measure does not represent, and should not be considered as an alternative to or superior to, financial results and measures determined or calculated in accordance with GAAP. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles. You should be aware that in the future we may incur expenses or charges that are the same as or similar to some of the adjustments in the presentation, and we do not infer that our future results will be unaffected by unusual or non-recurring items. In addition, this non-GAAP measure may not be comparable to similarly-named measures reported by other companies. Net income, the most directly comparable GAAP measure to Adjusted EBITDA, and a reconciliation of Adjusted EBITDA to net income are not included herein because we are not able to estimate certain components of these measures without unreasonable effort. In addition, the Company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. The variability of the specified items may have a significant and unpredictable impact on our future GAAP results.
We use Adjusted EBITDA to facilitate company-to-company operating performance comparisons by backing out potential differences caused by variations in capital structures (affecting interest expense), taxation and the age and book depreciation of facilities and equipment (affecting relative depreciation expense), which may vary for different companies for reasons unrelated to operating performance. We believe that this measure, when considered together with our GAAP financial results, provides management and investors with a more complete understanding of our business operating results, including underlying trends, by excluding the effects of transaction costs, net loss (gain) on sale and retirement of assets, business realignment costs and certain impairments. Further, while discretionary bonuses for members of management are not determined with reference to specific targets, our board of directors may consider Adjusted EBITDA when determining discretionary bonuses.