La cadena de opciones muestra datos clave de las opciones de acciones de Ibotta a varios precios de ejercicio y fechas de vencimiento. Los operadores utilizan esta información para analizar posibles operaciones y evaluar el sentimiento del mercado para Ibotta..

Ibotta (NYSE:IBTA) Bolsa, Cadena de Opciones

IBOTTA INC-CL A

Ibotta

Ibotta Inc is a performance marketing platform. It allows CPG brands to deliver digital promotions to consumers through a single, convenient network called the Ibotta Performance Network (IPN).

Ibotta Inc

A federal judge on Friday vacated a Biden-era rule that would have stripped medical debt from consumer credit reports, siding with credit-industry and Trump-administration arguments that regulators overreached.
What Happened: According to a Reuters report, U.S. District Judge Sean Jordan said the Consumer Financial Protection Bureau rewrote the Fair Credit Reporting Act when it finalized the policy in January, a move he ruled exceeded the agency's authority.
His decision blocks a measure the CFPB estimated would erase about $49 billion in liabilities from the records of 15 million Americans and bar lenders from using medical data in loan decisions. The judge, a 2019 Donald Trump appointee, noted that Congress lets credit bureaus report coded medical debts and that federal law pre-empts stricter state limits.
Experian, Equifax and TransUnion argued the rule would give lenders an incomplete picture of a borrower's ability to repay, even after they voluntarily stopped listing medical collections under $500 in 2022. "This is the right outcome for protecting the integrity of the system," Consumer Data Industry Association chief executive Dan Smith <a href="https://www.cdiaonline.org/news/2025/07/11/court-vacates-cfpb-rule-on-medical-debt/">said</a>.
See also: <a href="https://www.benzinga.com/personal-finance/financial-advisors/25/07/46386533/dave-ramsey-warns-bankruptcy-is-huge-red-flag-that-can-delay-homeownership-by-years">Dave Ramsey Warns Bankruptcy Is &#8216;Huge Red Flag&#8217; That Can Delay Homeownership By Years</a>
Why It Matters: The Biden administration adopted the ban after research showed medical bills, which include shocks from accidents or hospital stays, distort credit scores yet reveal little about long-term solvency. Roughly one in 12 adults carries <a href="https://www.kff.org/key-facts-about-hospitals/?entry=out-of-pocket-spending-and-medical-debt-medical-debt">at least</a> $250 in unpaid medical debt. A CFPB statement in January called the measure a common-sense fix for families who would see scores rise by as much as 20 points.
Consumer advocates condemned Friday's ruling and urged the White House to appeal, but the Justice Department has not defended the rule since the CFPB reversed course under President Trump. The policy's <a href="https://www.benzinga.com/personal-finance/financial-advisors/25/05/45185435/medical-debt-rule-on-the-brink-who-is-impacted">fate grew uncertain</a> after that reversal, warning millions could still face higher borrowing costs.
The now-vacated rule anchored a broader White House strategy that also <a href="https://www.ncdhhs.gov/news/press-releases/2025/02/05/hospital-payment-program-and-medical-debt-relief-initiative-approved-another-year">steered</a> Medicaid funds to North Carolina hospitals that forgave patient balances.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/news/politics/25/07/46387398/trump-accepts-king-charles-invite-for-rare-second-state-visit-to-uk-amid-political-backlash">Trump Accepts King Charles&#8217; Invite For Rare Second State Visit To UK—Amid Political Backlash</a></li>
</ul>
Photo Courtesy: Salma Bashir on Shutterstock

Health Care

General

Texas Judge Blocks Biden-Era Rule Meant To Erase $49 Billion In Medical Debt From Credit Reports

HC Wainwright &amp; Co. analyst Raghuram Selvaraju initiates coverage on Innoviva (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INVA#NASDAQ">INVA</a>) with a Buy rating and announces Price Target of $40.

News

Price Target

Initiation

Analyst Ratings

INVA

HC Wainwright & Co. Initiates Coverage On Innoviva with Buy Rating, Announces Price Target of $40

Insider Trades

Robert Leshner Reported A 56.9% Stake In LQR House In 13D Filing

<ul>
<li>Appoints Current Kenvue Director and Proven CPG and Technology Company Leader, Kirk Perry, as Interim CEO, Effective Immediately</li>
<li>Announces Ongoing Review of Strategic Alternatives</li>
<li>Reports Select Preliminary Second Quarter 2025 Financial Results</li>
</ul>
Kenvue Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KVUE#NYSE">KVUE</a>) today announced that its Board of Directors is implementing a set of actions to enable the Company to unlock shareholder value and reach its full potential. The Board has made a Chief Executive Officer transition and is advancing an ongoing comprehensive review of strategic alternatives.
Advancing Strategic Review
The Board had previously initiated a comprehensive review of strategic alternatives and has established a Strategic Review Committee to oversee the ongoing process. The strategic review will consider a broad range of potential alternatives, including optimizing the Company's brand portfolio, while improving execution and enhancing operating performance to accelerate profitable growth and unlock the inherent value in Kenvue.
The Board and the Strategic Review Committee are being advised by Centerview Partners and McKinsey &amp; Company. The Company plans to update shareholders as the strategic review progresses.

KVUE

Kenvue Board Forms Committee For Strategic Review With Centerview and McKinsey Advisors To Accelerate Growth And Value

Needham analyst Bernie McTernan maintains Uber Technologies (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UBER#NYSE">UBER</a>) with a Buy and raises the price target from $100 to $109.

UBER

Needham Maintains Buy on Uber Technologies, Raises Price Target to $109

Fastenal (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FAST#NASDAQ">FAST</a>) reported quarterly earnings of $0.29 per share which beat the analyst consensus estimate of $0.28 by 3.57 percent. This is a 11.54 percent increase over earnings of $0.26 per share from the same period last year. The company reported quarterly sales of $2.08 billion which beat the analyst consensus estimate of $2.07 billion by 0.28 percent. This is a 8.56 percent increase over sales of $1.92 billion the same period last year.

Earnings

Earnings Beats

FAST

Fastenal Q2 EPS $0.29 Beats $0.28 Estimate, Sales $2.08B Beat $2.07B Estimate

Hesai Group ("Hesai" or the "Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HSAI#NASDAQ">HSAI</a>), the global leader in three-dimensional light detection and ranging (lidar) solutions, today announces that it has filed a Notice of Appeal to the U.S. Court of Appeals on July 13, 2025, to challenge the decision of the U.S. District Court for the District of Columbia ("District Court"), which upheld the U.S. Department of Defense's (DoD) designation of the Company under Section 1260H of the National Defense Authorization Act for Fiscal Year 2021.
"We are deeply disappointed by the District Court's ruling and respectfully disagree with its decision. We believe the DoD's designation lacks both factual and legal bases," said Yifan "David" Li, the CEO of Hesai. "We are appealing to the U.S. Court of Appeals, and we will vigorously pursue all legal avenues to protect our reputation and seek fair treatment."
Critically, the District Court acknowledged that the DoD found no evidence that Hesai's products have been used for military purposes, nor any evidence of a direct or indirect connection between Hesai and the Chinese military — fundamental facts Hesai has maintained all along.
Instead, the District Court based its ruling solely on two factors: the geographic location of Hesai's R&amp;D centers within certain industrial districts, and the theoretical potential that technologies such as lidar could have military applications. These speculative rationales—which could apply equally to countless other companies operating in China, including American and international companies—fall far short of demonstrating that Hesai has actually contributed to the military in any way, as the statute requires.
Hesai has never developed, supplied, or certified products for military use, as its products are solely for civilian and commercial uses. Hesai will continue to defend its integrity and pursue appropriate legal remedies. At the same time, Hesai remains focused on delivering cutting-edge lidar solutions to its global customers and maintaining its unwavering commitment to transparency and good corporate governance as a Nasdaq-listed company.

Legal

HSAI

Lidar Maker Hesai Fights Pentagon Blacklist, Appeals US Court Ruling Over China Ties

HC Wainwright &amp; Co. analyst Raghuram Selvaraju reiterates Abeona Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) with a Buy and maintains $20 price target.

Reiteration

ABEO

HC Wainwright & Co. Reiterates Buy on Abeona Therapeutics, Maintains $20 Price Target

Castellum, Inc. (NYSE-American: CTM) (the "Company" and "Castellum"), a cybersecurity, electronic warfare, and software services and solutions company focused on the federal government, releases this letter to shareholders from <a href="https://www.globenewswire.com/Tracker?data=3Umz9Wpg3-fccBTbn9THik7dLcOSVg9GMThkCmzsLS_muZDDRiZOkk19lAwjWxES8C9Q7lJZawc9fwBYsbJAN3Z01Mkbk41sJX6LbF_ZJAoJUvbh2kt6ndEwm4foQW66Xw3BwIXKZLPYRItgqAlyuTXpuphZT2d-ucsILggdZ70=">Chief Executive Officer ("CEO"), Glen Ives.</a>
Dear Fellow Shareholders:
With this month marking the one-year anniversary of my time as your CEO, I thought it an opportune time to thank you sincerely for your support and confidence in<a href="https://www.globenewswire.com/Tracker?data=2a-c6V_SP0k-aNXr_WWhzeaydRYjCsL9JpsSaqiVUm96O2ERlaeTdQd5BELP0rua7rU7gOpLhTPsdYDsoU-U7ZYc2ZKCe790u6IFh30RRc8="> Castellum, Inc</a>., re-emphasize how incredibly honored I continue to be to have this opportunity to lead <a href="https://www.globenewswire.com/Tracker?data=itxch3VDyJLd9KwH02kos34hghcUriOfAe1-JVQ8vNtPbHAvJWJyVYRRpebvJsiP6WkZT7ww7qW6Ap04qBLWo1pgfI4fUnNZHlHS-CEgo6M=">our CTM team,</a> provide a very brief update on our significant progress over this past year, and explain why I continue to be encouraged, confident, and genuinely excited for all of us at CTM as we look ahead.
Since I assumed my role as your CEO on July 1st of last year, CTM has quickly and strategically transitioned from our four-year Phase 1 "start-up" period, during which we were focused on acquiring and integrating seven companies and uplisting to the NYSE American LLC ("NYSE American"). Last July, we made a strategic pivot to Phase 2, focusing on strengthening our foundational platform through <a href="https://www.globenewswire.com/Tracker?data=JjodBAMH549HWzAwS7tXjOiKpx0zLDQEzWt3HYx6vssCkgtEySo2Bq86ChjYHXCnvot4BvBSL0zmaHRks8AEV-0PMAzr9Jixioli6h2x2-FYnO7mSWbLapsac8Wz2ohoD18KCyOxH276bEsInn4_0zyjlxFh_XVl4PrVAkRLn3sC-jO2KG_ge-TPZKLXcQJeubyuzFscHO677NFRtu1vqnTtMkZaV7iAl7ui5O03NoWsytbIy8-gRedpqTTHcJToHoHFPyWt-1fFZV7zyJEd-Q==">organic growth.</a>&nbsp;As I have affirmed constantly, time and again since last summer, our Phase 2 strategy is based upon a total, 100%, uncompromising, "all hands" commitment to organic growth.
Over the past year, our CTM Team has been improving and energizing every aspect of our Company to compete in the "full and open" arena, as defined by the government, as a "large" business. We are completely integrated across CTM in every business function and have been laser focused on strengthening business development ("BD") and organic growth through a broadening, deepening, and quality improvement of our opportunity pipeline and significantly enhancing our prospective capabilities in the key BD areas of opportunity development, capture management, and proposal development.
Here's a brief recap of what we have accomplished <a href="https://www.globenewswire.com/Tracker?data=4BW0BAupTf-yMj0RzAGbdL9_slwNItZcIXpOcwI8JfqxuwKLu-5XU8t8ewpVx7WgVKHICHCk91682dIyVFdM1Q7C6XcSnqdA5svhtA_rQ5NYHazIhlDJzF3Tus7Gn4Lv">since July 1, 2024</a>:
<ul>
<li>Leadership team restructured and strengthened with greater industry and technology experience:</li>
<li>Raised over $16 million through public offerings and warrant exercises;</li>
<li>Reduced our <a href="https://investors.castellumus.com/news/news-details/2025/Castellum-Inc--Retires-Promissory-Note-Early/default.aspx">long-term debt to less than $5 million today</a>;</li>
<li>Strong and healthy balance sheet – Improved cash/equity to debt ratio;</li>
<li>Won largest prime contract in CTM history with <a href="https://investors.castellumus.com/news/news-details/2025/Castellum-Inc.-Announces-the-Award-of-a-103.3-million-Contract-to-its-GTMR-Subsidiary/default.aspx">$103.3&nbsp;million, a 5.5-year&nbsp;contract for Special Missions</a>&nbsp;support of the Naval Air Systems Command Program Office PMA 290 Special Missions;</li>
<li>Established <a href="https://investors.castellumus.com/news/news-details/2025/Castellum-Inc.s-SBA-Protgs-Successfully-Onboard-to-SeaPort-NxG-Contract/default.aspx">two mentor-protégé relationships</a>&nbsp;and related joint ventures with woman-owned and native Hawaiian organizations;</li>
<li>Established a <a href="https://investors.castellumus.com/news/news-details/2025/Castellum-Inc--Announces-Creation-of-New-Subsidiary-to-Focus-on-Advanced-Technology-Products/default.aspx">new subsidiary</a> to focus on advanced technology products;</li>
<li>Consistent "best in industry" contractor performance assessment reports ("CPARS"), which is our "report card" from our government customers; and</li>
<li>Significant improvement and increases in the volume and quality of our proposals ... for baseball fans, we want to get more at-bats, take more swings at the right pitches, get on base more with a good balance of singles, doubles, triples, and home runs.</li>
</ul>
Today, we are an intensely competitive, leading-edge technology services and solutions team committed to national security and our warfighters. We provide relevant, timely, and world-class mission services and solutions to our defense and federal civilian customers through our government-awarded contracts. <a href="https://www.globenewswire.com/Tracker?data=RZD3Ht1ZP4si6EUCCdqTSs2I0Ge8Qr6nlNI88VUL28feThPODPMlAWdmijjZPAUdWiZi5dgBwPNBMylPae0jmrg8tBOUVvRMyVvJnHfVCiow_0prdbJS2uQBQhvxlW40p8cOI0c5lcRbGwrQvoP9PPg8cqVeol2TO4b-bmu3Yq4=">We bring unparalleled capabilities</a> in software and systems engineering and integration, software development, and model-based systems engineering across every technology domain and mission area vital to our government mission customers. Going forward, our new advanced technology products subsidiary will complement our historic strong suit of tech-enabled services with the tech itself.
Relevant, powerful, high-demand, high-value technology domains and mission capabilities:
<ul>
<li>Software development, software and systems engineering, systems integration, model-based systems engineering;</li>
<li>Electronic and information warfare;</li>
<li>Cybersecurity, AI/ML, data analytics, digital modernization, <a href="https://c5isrcenter.devcom.army.mil/">C5ISR</a>;</li>
<li>Data and intelligence analysis; and</li>
<li>Strategic mission, policy planning, and development.</li>
</ul>
At the very core, we have built and are building a premier, cohesive team - I couldn't be prouder of the whole team we have built, top to bottom, left to right. We have brought together seven different companies, professionals from outside those organizations, and built an integrated and focused team that has been responsible for the many positive things that have happened, are happening, and will continue to happen.
<ul>
<li>With the equity raises, we will be able to lean into investments we are already making - business development and IT for organic growth, and it will allow us to pursue growth by acquisitions;</li>
<li>Contract wins will build success – credibility, service, and revenue;</li>
<li>Strong CPARS speaking to the high quality of our work;</li>
<li>Increase in proposals – improves our opportunities for winning; and</li>
<li>With our mentor-protégé joint ventures, we grow our business and help establish two worthy companies.</li>
</ul>
We are now where we wanted to be when we first uplisted to the NYSE American in October 2022. We have now raised the capital we intended to support our organic and inorganic growth strategies. Since the time of uplisting, we have honed our skills and integrated our teams to be a better, stronger company. We are committed to winning and growing contracts, as well as making strategic acquisitions, to achieve our goal of becoming a large, premier defense company.

Castellum CEO Marks 1 Year With Big Contract Wins, Lower Debt, and Plans to Grow Defense Tech Business

Guidance

Kenvue Preliminary Q2 Net Sales Down 4%; EPS $0.21 - $0.22 And Adj EPS $0.28 - $0.29

HC Wainwright &amp; Co. analyst Kevin Dede reiterates CoreWeave (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRWV#NASDAQ">CRWV</a>) from Neutral to Neutral.

CRWV

HC Wainwright & Co. Reiterates Neutral on CoreWeaveto Neutral

Management

Kenvue Board Appoints Kirk Perry As Interim Chief Executive Officer, Effective Immediately

Needham analyst Scott Berg initiates coverage on Shopify (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SHOP#NASDAQ">SHOP</a>) with a Buy rating and announces Price Target of $135.

SHOP

Needham Initiates Coverage On Shopify with Buy Rating, Announces Price Target of $135

Babcock &amp; Wilcox Enterprises, Inc. ("B&amp;W" or the "Company") (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BW#NYSE">BW</a>) announced today an amendment to its previously announced offers to purchase for cash (the "Cash Offers") up to a maximum $70 million aggregate amount of Tender Consideration of the Company's 8.125% Senior Notes due 2026 (the "February 2026 Notes") and 6.50% Senior Notes due 2026 (the "December 2026 Notes" and, together with the February 2026 Notes, the "Notes"). The Cash Offers are being made upon the terms and subject to the conditions set forth in the Offer to Purchase, dated June 5, 2025, as amended (the "Offer to Purchase"). The amendment provides for an extension of each of the Withdrawal Deadline and the Expiration Date of the Cash Offers to 5:00 p.m., New York City time, on August 15, 2025. Capitalized terms used but not defined in this announcement have the meanings given to them in the Offer to Purchase.
The following table sets forth the principal amount of Notes validly tendered and not validly withdrawn as of 5:00 p.m., New York City time, on July 11, 2025.
<figure class="table"> 
<table>
<tbody>
<tr>
<td colspan="1" rowspan="1">Title of Series of Notes to be Purchased</td>
<td colspan="1" rowspan="1">CUSIP No.</td>
<td colspan="1" rowspan="1">Outstanding Principal Amount as of June 5, 2025 (in millions)</td>
<td colspan="1" rowspan="1">Principal Amount Tendered (in millions)</td>
</tr>
<tr>
<td colspan="1" rowspan="1">8.125% Senior Notes due 2026</td>
<td colspan="1" rowspan="1">05614L 308</td>
<td colspan="1" rowspan="1">$109.02</td>
<td colspan="1" rowspan="1">$13.23</td>
</tr>
<tr>
<td colspan="1" rowspan="1">6.500% Senior Notes due 2026</td>
<td colspan="1" rowspan="1">05614L 506</td>
<td colspan="1" rowspan="1">$103.63</td>
<td colspan="1" rowspan="1">$7.32</td>
</tr>
</tbody>
</table>
</figure>
Our obligation to complete the Cash Offers is conditioned on the consummation, prior to or concurrently with the Expiration Date, of (i) the sale, to certain legal entities affiliated with Andritz AG, of the equity interests of Diamond Power International, LLC ("Diamond Power") and related legal entities, together with assets related to the Diamond Power business and (ii) the receipt of net proceeds from such sale in an amount sufficient to fund the Cash Offers, assuming the maximum Tender Consideration of $70 million (the "Diamond Power Closing Condition"). As of 5:00 p.m., New York City time, on July 11, 2025, the Diamond Power Closing Condition was not satisfied.

Babcock & Wilcox Extends Offer to Buy Back $70M in Debt, Tied to Pending Business Sale

BTCS Inc. (Nasdaq:&nbsp;<a href="https://www.globenewswire.com/Tracker?data=861YCsjy1I4h2W56zziuqDM_d4kAx68q9hu25aMCZdoZtkBUPxfeE7h_p1EaTuwTkqXzQaFZDx33rZktBY3kGA==">BTCS</a>) ("BTCS" or the "Company"), a blockchain technology-focused company short for Blockchain Technology Consensus Solutions, announced today that it has raised $62.4 million year-to-date in minimally dilutive capital while expanding BTCS's Ethereum holdings to 29,122 a 221% increase from year end 2024.
"By increasing our ETH per share while simultaneously driving meaningful revenue growth, we are building the premier Ethereum-focused public company," said Charles Allen, CEO of BTCS. "BTCS stands apart in two keyways: first, our hallmark DeFi/TradFi flywheel, enables us to access capital at a low cost and deliver, leveraged exposure to Ethereum, and second our established track record, we're the world's oldest public blockchain company and have been laser focused on Ethereum infrastructure for nearly five years."
Ethereum Holdings Snapshot As of Friday, July 11, 2025, BTCS's ETH holdings include:
<ul>
<li>Total ETH holdings: 29,122</li>
<li>ETH Market Value: $87.3 million at $3,000 per ETH</li>
<li>Staked ETH: 4,160 via Rocket Pool Nodes, 6,300 via Solo Nodes, 4,382 in staking queue</li>
<li>ETH posted to Aave as collateral: 14,280 with current annual earnings at approximately 2%</li>
</ul>

Coverage of Bitcoin, Etherum, Ripple and all the latest digital currencies.

Cryptocurrency

Markets

BTCS

BTCS Grows Ethereum Holdings to Over $87M, Up 221% Since Last Year

Amesite Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMST#NASDAQ">AMST</a>), a leading developer of AI-powered enterprise solutions, today announced the launch of the new NurseMagic&#x2122;&nbsp;Enterprise Tier, built to meet the most urgent needs of mid- and large-scale post-acute healthcare providers. Developed in direct response to customer demand, NurseMagic&#x2122; Enterprise integrates advanced, AI-powered capabilities into existing workflows&nbsp;— seamlessly and compliantly. By aligning pricing with patient census, Amesite believes this offering significantly increases its addressable market and supports long-term revenue growth.

AMST

Amesite Launches NurseMagic Enterprise Tier To Meet Demands Of Mid- And Large-Scale Post-Acute Healthcare Providers

Collective Mining Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CNL#NYSE">CNL</a>) (TSX:<a class="ticker" href="https://www.benzinga.com/stock/CNL#TSX">CNL</a>) ("Collective" or the "Company") is pleased to announce assay results for six diamond drill holes designed to better outline and expand the shallow portion of gold-silver-copper-tungsten mineralization at the Apollo system ("Apollo"). Apollo, which begins at surface and is strongly mineralized over 1,200 vertical metres and open at depth, is the most advanced discovery made to date within the Company's multi-target, Guayabales project in Caldas, Colombia.
The Company currently has nine drill rigs operating as part of its fully funded 70,000 metre drill program for 2025 with seven rigs operating at the Guayabales Project and two rigs turning at the San Antonio Project. Drilling in the Guayabales Project is focusing on defining the shallow mineralization, high-grade sub-zones, expanding the high-grade Ramp Zone at depth and testing a series of Apollo look-alike gravity targets which were announced recently (see press release dated June 30, 2025). Two additional deep capacity rigs are being mobilized to resume testing the high-grade Ramp Zone with the first of these rigs expected to begin operations by early August 2025.
Approximately 129,500 metres of diamond drilling has been completed to date at the Guayabales Project, including 91,000 metres at Apollo. There are currently twenty-five drill holes in the lab with assay results for most of these holes expected in the near term.

TSX:CNL

Collective Mining Strikes More Gold, Silver, and Copper in Colombia With New Drilling Results

Macro Economic Events

Econ #s

Economics

INDA

India Consumer Price Index (YoY) For June 2.10% Vs. 2.50% Est.; 2.82% Prior

The adaptive clinical trial is designed to provide information on three important aspects in a single, compact clinical trial:
safe and effective dosing regimen in patients,
safety and tolerability of the drug in patients, and
antiviral effectiveness of the drug in patients.
The overall clinical trial will enroll approximately 80 patients.
"This is an important milestone towards filing of the clinical trial application and starting the clinical trial," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "Our CRO and the Principal Investigator have created a marvelous design that is both frugal and efficient while providing all of the information necessary for understanding the safety and effectiveness of NV-387 for treating MPox disease."
Currently there is no drug approved for the treatment of MPox disease that is actually effective for treating the disease.
NV-387, if it shows effectiveness, will be the very first drug that has shown effectiveness in human clinical trial of an orthopoxvirus.
If NV-387 is found to be effective in this Phase II clinical trial, the Company intends to continue further development of NV-387 for treatment of orthopoxvirus infections under a US FDA IND towards studies as needed for regulatory approval of NV-387 for the treatment of MPox as well as Smallpox indications. The Company intends to obtain regulatory approval in the African Region as well, which is likely to arrive before a US approval, and also seek approvals in the European Union and other countries and regions.
MPox is an Orphan disease in the USA and treatment of MPox by NV-387 is eligible for Orphan Drug Designation by the US FDA with attendant benefits.
Smallpox is a bioterrorism agent of concern in the USA as well as across the world and is an important revenue opportunity for the Company. Tecovirimat sales to the US Government alone have netted SIGA, the drug holder, over $600 million through December 31, 2024, according to SIGA's annual report to the SEC [1] .
The adaptive, randomized, SOC controlled clinical trial will proceed in two parts:
In Phase IIa part, an oral dose of the drug NV-387 given twice daily initially for six days will be compared with the standard of care (SOC) at the hospital for treatment of MPox disease. Patients will be sequestered in the hospital and will be evaluated daily for clinical drug safety and tolerability parameters, and clinical MPox disease evaluation parameters. Additionally, lab evaluations including clinical blood chemistry, CBC, cytokines, urinalysis, ECG, X-rays when necessary, and virological assays will be conducted every 3 days. Based on the results, the Principal Investigator will determine whether additional days of drug dosing can be well tolerated and can improve on effectiveness. If so, the patients will continue to receive same dosing for six more days with same evaluations. The patients will be followed until full resolution of the MPox disease.
There will be two arms in this Phase IIa: The New Treatment Arm of 10 patients with NV-387 dosing plus SOC and the control SOC Arm of 10 patients. The dosing regimen for Phase IIb will be determined on the basis of Phase IIa results.
In the Phase IIb part, the clinical trial will be in a 2:1 randomized patients base with approximately 40 subjects in the New Treatment Arm and 20 patients in the SOC Arm. Evaluations will be similar to those in Phase IIa, with more emphasis given to specific points that may have come up in Phase IIa regarding safety, tolerability, as well as efficacy.
The Phase IIa will be conducted at a single site in Democratic Republic of Congo (DRC). Phase IIb may be expanded to include additional sites within DRC as well as other countries experiencing severe MPox outbreak in the African Region.
The "NV-387 Oral Gummies" drug product formulation will be employed in the Phase II. This is a soft solid formulation that is designed to stick in the oral cavity and dissolve naturally over time, with no solid object (pill or capsule) swallowing necessary. This is important for MPox because MPox causes lesions on mucosal surfaces that make swallowing painful and difficult. MPox is primarily known for the explicit characteristic painful rash on the external skin, but it is a significantly more severe disease than just a skin rash.
Two drugs, Tecovirimat and Brincidofovir were approved by the US FDA for Smallpox and MPox on the basis of the US FDA "Animal Rule," i.e. based on animal infection and treatment studies only to demonstrate efficacy, and a safety/tolerability human clinical trial.
Tecovirimat failed in clinical trials for the treatment of MPox with no improvement over the standard of care. Brincidofovir was abandoned in a clinical trial of MPox due to first three patients coming down with drug induced liver injury. Despite this, brincidofovir was recently resurrected under an international coalition led by US CDC and first patient was dosed around January 2025 in the "MOSA" clinical trial [2] . The topline results were expected to be announced as early as CY Q1 (March 2025) and efficacy topline data were expected no later than CY Q2 (June, 2025). No press releases post initiation of the MOSA clinical trial could be found.
The MPox virus circulating in DRC and neighboring regions is of Clade 1a and Clade 1b subtypes, with the latter predominant. Clade 1b is more transmissible of the two, which is why it has resulted in a sustained epidemic. The MPox Clade 1a case fatality rate (CFR) is about 3%-11% whereas the CFR for Clade 1b is about 1%. The MPox Clade 2b is the virus causing continuing cases in the Western world, which causes a much less severe disease than Clade 1a/1b and has a very low CFR, according to CDC. Sporadic cases of Clade 1 in the Western world continue to occur. Four separate travel-related MPox Clade 1 cases reported in the USA that did not result in any further spread, since November 2024, according to the CDC [3] .
Clearly, the threat of MPox Clade 1 causing a potential epidemic in the USA cannot be ignored, and readiness with a drug that works against the same is important to achieve.

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Nanoviricides Announces That The Design Of The Adaptive Clinical Trial Protocol For Mpox Virus Clade Ia And Ib Infections And Disease Is Nearly Complete

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