Ultime notizie per SIGA Technologies (NASDAQ:SIGA) Azioni

SIGA Technologies

SIGA Technologies Inc is a commercial-stage pharmaceutical company focused on the health security market. The company's main product is TPOXX, an oral formulation antiviral drug for the treatment of human smallpox disease caused by the variola virus. The company derives maximum revenue from United States.

SIGA Technologies Inc

SIGA Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) reported quarterly losses of $(0.01) per share. This is a 107.14 percent decrease over earnings of $0.14 per share from the same period last year. The company reported $7.04 million in sales this quarter. This is a 72.31 percent decrease over sales of $25.43 million the same period last year.

Earnings

News

SIGA

SIGA Technologies Q1 EPS $(0.01) Down From $0.14 YoY, Sales $7.04M Down From $25.43M YoY

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Earnings Scheduled For May 8, 2025

<a href="https://www.ncdhhs.gov/news/press-releases/2025/04/22/mpox-found-wastewater-north-carolina-ncdhhs-urges-public-and-providers-be-alert" title="https://www.ncdhhs.gov/news/press-releases/2025/04/22/mpox-found-wastewater-north-carolina-ncdhhs-urges-public-and-providers-be-alert">https://www.ncdhhs.gov/news/press-releases/2025/04/22/mpox-found-wastewater-north-carolina-ncdhhs-urges-public-and-providers-be-alert</a>

Trading Ideas

Watching SIGA Technologies; Shares See Volume To The Upside, Earlier Reports Say NC Department Of Health And Human Services Said Mpox Found In Wastewater In North Carolina From Samples Collected On March 25, March 28 & April 8 From Treatment Plant In Greenville; No Mpox Clade I Cases Have Been Reported To Date

WIIM

SIGA Technologies shares are trading higher after the company announced a special cash dividend.

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General

SIGA Technologies Declared A Special Cash Dividend Of $0.60 Per Share Payable On May 15, 2025, To Shareholders Of Record At The Close Of Business On April 29, 2025

SIGA Technologies&#8217; (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) antiviral drug tecovirimat, when used without other treatments, did not reduce the time for clade II mpox lesions to heal or significantly alleviate pain, according to results from an international clinical trial sponsored by the <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">National Institutes of Health (NIH)</a>.
The study, known as STOMP, was halted in late 2024 after an interim analysis indicated the drug was ineffective in the study population.
Mpox has two <a target="_blank" href="https://www.niaid.nih.gov/news-events/tecovirimat-safe-ineffective-treatment-clade-ii-mpox" rel="noreferrer noopener">identified</a> variants: clades I and II. A clade II outbreak in 2022 led to global transmission, with continued low-level circulation.
Meanwhile, a clade I outbreak in Central and East Africa was declared a public health emergency in 2024.
STOMP launched in September 2022 as part of a U.S. government initiative addressing the clade II mpox outbreak.
No mpox-specific treatments have been approved in the U.S.
Tecovirimat, also known as TPOXX, was originally authorized by the FDA to treat smallpox based on animal studies but had not been evaluated in humans with mpox before STOMP and a parallel study, PALM007, conducted in the Democratic Republic of the Congo.
PALM007 yielded similar results from STOMP, further questioning tecovirimat's effectiveness for mpox.
Results showed that by day 29, 83% of participants taking tecovirimat had achieved clinical resolution, compared to 84% in the placebo group, indicating no meaningful difference.
Among those who reported severe pain at the study's outset, pain reduction was similar across groups, with tecovirimat users reporting an average decrease of 3.2 points on an 11-point scale, compared to 3.1 points for placebo recipients.
Viral DNA levels declined over time in both groups, with no statistically significant differences at key checkpoints.
Adverse event rates were also comparable between treatment and placebo groups.
A separate exploratory analysis examined STOMP's open-label participants—those at higher risk of severe mpox. The analysis found that younger participants and those without HIV or with well-controlled HIV experienced faster lesion resolution. 
However, no strong correlation was observed between symptom duration before study entry and recovery speed. Researchers noted that open-label participants had fewer lesions but slower recovery compared to PALM007 trial participants.
On Tuesday, SIGA Technologies reported <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44262141/siga-reports-financial-results-for-three-and-twelve-months-ended-december-31-2024" rel="noreferrer noopener">fourth-quarter earnings</a> of 63 cents, down from $1.01, and sales of $81.4 million, down $116.5 million <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">from a year ago</a>.
Price Action: SIGA stock is up 7.05% at $6.02 at the last check Wednesday.
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Photo: Shutterstock

NIH Trial Finds Tecovirimat Ineffective As Monotherapy For Mpox

<a href="https://www.niaid.nih.gov/news-events/tecovirimat-safe-ineffective-treatment-clade-ii-mpox">https://www.niaid.nih.gov/news-events/tecovirimat-safe-ineffective-treatment-clade-ii-mpox</a>
The antiviral drug tecovirimat used without other antivirals did not reduce the time to clinical resolution of clade II mpox lesions or improve pain control among adults in an international clinical trial sponsored by the National Institutes of Health (NIH). The&nbsp;<a href="https://www.niaid.nih.gov/news-events/nih-study-finds-tecovirimat-was-safe-did-not-improve-mpox-resolution-or-pain">trial enrollment was stopped in late 2024</a> when an interim analysis showed that tecovirimat monotherapy was ineffective in the study population. Detailed results were presented at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.

'Tecovirimat Is Safe But Ineffective As Treatment For Clade II Mpox' - NIH

Guidance

SIGA Says It Remains Focused On Durable Growth And Impact As It Enters 2025, Supported By $70M Of Outstanding Procurement Orders

SIGA Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) reported quarterly earnings of $0.63 per share. This is a 37.62 percent decrease over earnings of $1.01 per share from the same period last year. The company reported $81.40 million in sales this quarter. This is a 30.13 percent decrease over sales of $116.50 million the same period last year.

SIGA Technologies Q4 2024 GAAP EPS $0.63 Down From $1.01 YoY, Sales $81.40M Down From $116.50M YoY

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This article was generated by Benzinga's automated content engine and reviewed by an editor.

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Earnings Scheduled For March 11, 2025

On Thursday,&nbsp;the Japan Ministry of Health, Labour and Welfare approved SIGA Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) antiviral treatment TEPOXX (tecovirimat 200 mg capsules) for smallpox, mpox, cowpox, as well as complications following smallpox vaccination in adults and pediatric patients <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g42761893/tepoxx-tecovirimat-approved-in-japan-for-the-treatment-of-orthopoxviruses" rel="noreferrer noopener">weighing at least 13 kg</a>.
TEPOXX is the first antiviral therapy for orthopoxviruses approved by Japan's drug regulator in collaboration with the Ministry of Health, Labour, and Welfare.&nbsp;&nbsp;
In partnership with Japan Biotechno Pharma, SIGA's exclusive distributor in Japan, SIGA has delivered an order of TEPOXX to help build Japan's strategic national stockpile.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40394363/in-nih-cosponsored-monkeypox-virus-study-in-congo-siga-technologies-antiviral-tecovirimat-did-not" rel="noreferrer noopener">In NIH-Cosponsored Mpox Virus Study In Congo, SIGA Technologies' Antiviral Tecovirimat Did Not Improve Lesion Resolution, Stock Tanks</a>
The Japanese approval is based on data from 15 clinical trials of oral TEPOXX in over 800 healthy volunteers, including a pivotal repeat-dose phase 1 pharmacokinetics (PK) trial involving 20 healthy volunteers conducted in Japan.
These studies showed no drug-related serious adverse events and quantifiable PK within efficacious dose ranges. Four pivotal studies in non-human primates (NHPs) and two pivotal studies in rabbits demonstrated that TEPOXX significantly reduced mortality and viral load.
TEPOXX is a highly targeted small-molecule antiviral that inhibits the VP37 protein found on the surface of all orthopoxviruses. By preventing the virus from exiting infected cells, TEPOXX slows the spread of the infection, enabling the immune system to clear the virus.
TPOXX is approved for smallpox in the U.S.&nbsp;and Canada. In the&nbsp;European Union and the UK, marketed as Tecovirimat-SIGA, it is approved&nbsp;for smallpox, mpox, and cowpox and to treat complications following smallpox vaccination.
Earlier this year, the National Institutes of Health's National Institute of Allergy and Infectious Diseases announced topline results from a preliminary analysis of the PALM 007 trial of<a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40394363/in-nih-cosponsored-monkeypox-virus-study-in-congo-siga-technologies-antiviral-tecovirimat-did-not" rel="noreferrer noopener"> tecovirimat for mpox</a>.
The study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the Democratic Republic of the Congo with mpox who were administered SIGA's tecovirimat versus placebo, weighing <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40534370/government-contract-win-may-improve-investor-sentiment-for-siga-tech-after-disappointing-trial-da" rel="noreferrer noopener">on the share price</a>.
Price Action: At last check Thursday, SIGA stock was up 3.01% at $6.19.
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<li><a href="https://www.benzinga.com/25/01/42763569/why-tutor-perini-shares-are-rising-premarket-on-thursday" target="_blank" rel="noreferrer noopener">Gary Smalley Takes The Helm As Tutor Perini's CEO; Ronald Tutor Stays On As Executive Chairman</a></li>
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Movers

Japan Approves SIGA Technologies Antiviral As First For Smallpox, Mpox

SIGA Technologies shares are trading higher after the company announced TEPOXX was approved in Japan for the treatment of orthopoxviruses.

Regulatory decision marks first approval in Japan of an antiviral for the treatment of orthopoxviruses including smallpox, mpox and cowpox.
Japan&nbsp;Biotechno Pharma Co., Ltd. engaged as exclusive distributor to supply TEPOXX to Japan's national stockpile. &nbsp;

SIGA Technologies Says TEPOXX (Tecovirimat 200 Mg Capsules) Has Received Regulatory Approval In Japan

U.S. stock futures were mixed this morning, with the Dow futures falling around 0.2% on Monday.
Shares of Arm Holdings plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARM#NASDAQ">ARM</a>) fell sharply in today's pre-market trading after a US jury reportedly found Qualcomm (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QCOM#NASDAQ">QCOM</a>) did not breach Nuvia&#8217;s license agreement <a href="https://www.benzinga.com/quote/ARM">with the company</a>.
Arm Holdings shares fell 2.3% to $129.14 in the pre-market trading session.
Here are some other stocks moving lower in pre-market trading.
<ul>
<li>Core Laboratories Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CLB#NYSE">CLB</a>) shares dipped 11% to $15.00 in pre-market trading.</li>
<li>Astria Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATXS#NASDAQ">ATXS</a>) shares declined 10.8% to $8.53 in pre-market trading.</li>
<li>SIGA Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) declined 8.5% to $5.41 in pre-market trading.</li>
<li>Dnow Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DNOW#NYSE">DNOW</a>) fell 7.7% to $11.90 in pre-market trading.</li>
<li>DiamondRock Hospitality Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DRH#NYSE">DRH</a>) fell 4.3% to $8.92 in pre-market trading.</li>
<li>NI Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NODK#NASDAQ">NODK</a>) fell 3.8% to $14.73 in pre-market trading.</li>
</ul>
Now Read This: 
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<li><a href="https://www.benzinga.com/trading-ideas/long-ideas/24/12/42616196/jim-cramer-likes-walmart-recommends-buying-this-very-very-good-financial-stock">Jim Cramer Likes Walmart, Recommends Buying This &#8216;Very, Very Good&#8217; Financial Stock</a></li>
</ul>

Pre-Market Outlook

Markets

ATXS

DNOW

NODK

QCOM

Arm Holdings And Other Big Stocks Moving Lower In Monday's Pre-Market Session

Shares of Rumble Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RUM#NASDAQ">RUM</a>) rose sharply in today's pre-market trading after the company announced it has entered into a definitive agreement for a strategic <a href="https://www.benzinga.com/24/12/42634166/rumble-stock-soars-on-775-million-investment-from-tether-what-to-know">investment of $775 million from Tether</a>.
Tether (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/">USDT</a>) has agreed to purchase 103.33 million shares of Rumble Class A Common Stock at a price per share of $7.50, totaling $775 million in gross proceeds to Rumble.
Rumble shares jumped 43.3% to $10.31 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>Reliance Global Group, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RELI#NASDAQ">RELI</a>) gained 234% to $4.01 in pre-market trading.</li>
<li>Phio Pharmaceuticals Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PHIO#NASDAQ">PHIO</a>) gained 88.6% to $3.32 in pre-market trading. Phio Pharmaceuticals, last week, announced a $1.15 million registered direct offering priced at-the-market under Nasdaq rules.</li>
<li>Edible Garden AG Incorporated (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDBL#NASDAQ">EDBL</a>) climbed 82.3% to $0.4334 in pre-market trading after surging 63% on Friday. Edible Garden recently announced it experienced a 51% year-over-year increase in its preliminary Thanksgiving period sales.</li>
<li>JIADE Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JDZG#NASDAQ">JDZG</a>) gained 60.9% to $0.8530 in pre-market trading. JIADE received Nasdaq notification letter regarding minimum bid price deficiency.</li>
<li>American Battery Technology Company (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABAT#NASDAQ">ABAT</a>) rose 44.1% to $1.60 in pre-market trading. On Friday, American Battery Technology priced its $5 million registered direct offering of 5 million shares at $1.00 per share.</li>
<li>SEALSQ Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LAES#NASDAQ">LAES</a>) gained 30.9% to $3.60 in pre-market trading after jumping more than 36% on Friday.</li>
<li>Brenmiller Energy Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNRG#NASDAQ">BNRG</a>) rose 28.8% to $0.9700 in pre-market trading after the company was awarded ISO/IEC 27001:2022 certification.</li>
<li>Honda Motor Co., Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HMC#NYSE">HMC</a>) gained 18% to $28.19 in pre-market trading. Honda Motor and Nissan Motor Co. Ltd. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/NSANY#OTC">NSANY</a>) have started talks for a potential merger.</li>
<li>Kodiak Sciences Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KOD#NASDAQ">KOD</a>) rose 14.9% to $9.94 in pre-market trading.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>Conduit Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDT#NASDAQ">CDT</a>) shares tumbled 28.9% to $0.0531 in pre-market trading after jumping 14% on Friday. Conduit Pharmaceuticals recently announced it entered an agreement with Sarborg to leverage AI and its cybernetics platform to evaluate key deliverables across multiple areas of operations.</li>
<li>Helius Medical Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HSDT#NASDAQ">HSDT</a>) declined 25.7% to $0.6759 in pre-market trading after jumping around 101% on Friday.</li>
<li>Onfolio Holdings, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ONFO#NASDAQ">ONFO</a>) fell 24.4% to $1.21 in pre-market trading. Onfolio Holdings announced a quarterly preferred stock cash dividend of 75 cents per share.</li>
<li>iLearningEngines, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AILE#NASDAQ">AILE</a>) shares fell 24.3% to $0.6703 in pre-market trading after declining 9% on Friday.</li>
<li>ConnectM Technology Solutions Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNTM#NASDAQ">CNTM</a>) shares dipped 20% to $0.83 in pre-market trading after falling 8% on Friday. ConnectM Technology Solutions, last week, announced a year-over-year increase in third-quarter revenue results.</li>
<li>TPI Composites, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TPIC#NASDAQ">TPIC</a>) fell 19.2% to $1.94 in today's pre-market trading after jumping 97% on Friday.</li>
<li>Aptose Biosciences Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APTO#NASDAQ">APTO</a>) dipped 17.8% to $0.2293 in pre-market trading after jumping 64% on Friday. Aptose Biosciences, last week, announced it was granted an extension to provide compliance evidence for a continued Nasdaq listing.</li>
<li>Core Laboratories Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CLB#NYSE">CLB</a>) fell 11% to $15.00 in pre-market trading.</li>
<li>Astria Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATXS#NASDAQ">ATXS</a>) shares fell 10.8% to $8.53 in pre-market trading.</li>
<li>SIGA Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) fell 8.5% to $5.41 in pre-market trading.</li>
</ul>
Now Read This: &lt;a href=&#8221;https://www.benzinga.com/news/earnings/24/04/38307448/investor-sentiment-decreases-further-s-p-500-falls-for-fourth-straight-session&#8221;&gt;&lt;em&gt; Investor Sentiment Decreases Further, S&amp;P 500 Falls For Fourth Straight Session&lt;/em&gt;&lt;/a&gt;

$USDT

ABAT

AILE

APTO

BNRG

CNTM

EDBL

HSDT

JDZG

LAES

NSANY

ONFO

PHIO

RELI

TPIC

Why Rumble Shares Are Trading Higher By Around 43%; Here Are 20 Stocks Moving Premarket

SIGA Technologies shares are trading lower after interim results from the STOMP study showed that Tecovirimat did not improve the time to lesion resolution compared to placebo in adults with mild to moderate clade II Mpox.

<a href="https://www.niaid.nih.gov/news-events/nih-study-finds-tecovirimat-was-safe-did-not-improve-mpox-resolution-or-pain">https://www.niaid.nih.gov/news-events/nih-study-finds-tecovirimat-was-safe-did-not-improve-mpox-resolution-or-pain</a>
<h2>Study Examined Tecovirimat in Countries Affected by Global Clade II Mpox Outbreak</h2>
&nbsp;
The antiviral drug tecovirimat did not reduce the time to lesion resolution&nbsp;or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease, according to an interim data analysis from the international clinical trial called the Study of Tecovirimat for Mpox (STOMP). There were no safety concerns associated with tecovirimat.&nbsp;
Considering&nbsp;these definitive findings, the study's Data Safety and Monitoring Board (DSMB) recommended stopping further enrollment of participants who were being randomized to tecovirimat or placebo. As the study sponsor, the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) accepted the DSMB's recommendation.&nbsp;Given the lack of an efficacy signal, NIAID also closed enrollment into an open-label study arm for participants with or at elevated risk of severe disease that was not designed to estimate the drug's efficacy.&nbsp;

'NIH Study Finds Tecovirimat Was Safe but Did Not Improve Mpox Resolution Or Pain'

SIGA Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) reported quarterly earnings of $0.02 per share. This is a 300 percent increase over losses of $(0.01) per share from the same period last year. The company reported $10.00 million in sales this quarter. This is a 8.28 percent increase over sales of $9.23 million the same period last year.

SIGA Technologies Q3 EPS $0.02 Up From $(0.01) YoY, Sales $10.00M Up From $9.23M YoY

SIGA Enters Exclusive License Agreement With Vanderbilt University To Obtain A License To A Portfolio Of Preclinical Fully Human Poxvirus Monoclonal Antibodies

The contract was executed in response to a request from the Ministry of Health in Morocco to make the therapy available in the country and help prepare and protect its citizens against any potential mpox outbreak.
Tecovirimat is approved in the U.S., Canada, and the EU, and while it has also been available in Africa through clinical trials and as part of the World Health Organization&#39;s emergency use access protocol, this agreement marks SIGA&#39;s first commercial sale of TPOXX on the continent.

Contracts

SIGA Technologies Enters Agreement To Supply TPOXX (Tecovirimat) In Morocco

Press Releases

SIGA Reports Financial Results for Three and Nine Months Ended September 30, 2024

Legal

SIGA Technologies (SIGA) Shares Tumble After Mpox Therapy Fails, Chief Medical Officer Terminated - Hagens Berman

Interim Results from STOMP Study of SIGA's Tecovirimat in Treatment of Mpox Announced

TEPOXX (tecovirimat) Approved in Japan for the Treatment of Orthopoxviruses

SIGA to Host Business Update Call on March 11, 2025 Following Release of Fourth-Quarter and Full Year 2024 Financial Results

SIGA Reports Financial Results for Three and Twelve Months Ended December 31, 2024

Management

SIGA Appoints Retired General John M. Keane to its Board of Directors

SIGA Declares Special Cash Dividend of $0.60 Per Share

SIGA to Host Business Update Call on May 8, 2025 Following Release of First-Quarter 2025 Results

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