Category: 3. Business

Introduction

On behalf of the New York Fed, let me welcome you all to this year’s U.S. Treasury Market Conference. Many thanks to the distinguished speakers and panelists for joining us here, and to the event organizers for putting together today’s outstanding agenda. I’m looking forward to a valuable and productive conversation.

This gathering is a recurring calendar item every fall. But the topics that we discuss each year do not stand alone. Think of it as leveling up in a video game—which is one of my favorite pastimes by the way, or dare I say, “present times”. At each conference, we advance our understanding of the Treasury market to the next level. And in the genre of gaming, this game is multiplayer. It’s remarkable to think about what we’ve accomplished in this decade-long enterprise of interagency collaboration. This work continues to be imperative, so we must keep playing. I mean that in the working sense, of course.

Before I keep going, I must give the standard Fed disclaimer that the views I express today are mine alone and do not necessarily reflect those of the Federal Open Market Committee (FOMC) or others in the Federal Reserve System.

Three Levels of Play

The remarks that I’ve given at past conferences have focused on taking stock of the Treasury market and sharing updates on our collective efforts.¹ My comments today will be a retrospective into the events, developments, and lessons learned over the past seven years. I will then explain how all of that has shaped the FOMC’s thinking around monetary policy implementation and the design of our ample reserves implementation framework. I’ll also bring you up to speed with regard to where the Federal Reserve stands on its balance sheet strategy.

So, let’s return to the video game analogy and start at level one—the episode of volatility known as the “flash rally” of 2014. That period of market stress served as a sharp reminder that financial markets are not static: they evolve in response to changes in technology, regulation, business models, and with the addition of new players and participants.

That initial level made it clear that safeguards and systems must evolve so that these markets can continue to function well in every circumstance and under any condition. So, from there, we jumped to the next level. And that’s the imperative of market resiliency. We learned the importance of creating a system that can better withstand the unforeseeable and the unpredictable. Because when the unforeseeable and unpredictable did happen, as we saw in the “dash-for-cash” in 2020, it resulted in significant stresses in the Treasury market and related markets that threatened to spread to broader financial conditions.

This leads me to level three. A resilient financial system is critically important for monetary policy. Because monetary policy influences the economy by affecting financial market conditions, its effectiveness relies on well-functioning markets, with the Treasury market at the heart of it all.

Good news—we’ve unlocked the next level of my remarks. And that is an explanation of the FOMC’s approach to monetary policy implementation to support effective interest rate control and smooth functioning of these core markets.

Framing the Frameworks

We’ve established that monetary policy implementation frameworks are critically important to the conduct of monetary policy.²

In supplying reserves to the banking system, the Federal Reserve has multiple goals that frequently involve trade-offs.³ First and foremost, it targets a level of the policy interest rate and aims to minimize the variability of the policy rate around that target. In addition, it has objectives related to supporting financial stability and the smooth functioning of financial markets.

The core of any operational framework is the supply of reserves, which can range from a low level, or “scarce,” to “ample” and “abundant.” The “price” of reserves is the spread between the market interest rate and the rate earned for holding reserves at the central bank. When reserves are scarce, the slope of the demand curve for reserves is steep. A small change in the quantity of reserves results in a meaningful change in the spread. When reserves are ample, the demand curve flattens but still slopes downward, so that small changes in the quantity of reserves have modest effects on the spread. And when reserves are abundant, the demand curve is essentially flat.

A central bank has two sets of tools it can use to supply reserves. First, it chooses an ex ante aggregate level of reserves to supply to the banking system. Second, it may make available lending facilities to the banking system that offer loans to financial institutions at an interest rate determined by the central bank. If the ex ante supply of reserves is sufficiently low, the additional demand will be met by the lending facilities. Note that both tools are a means to supply reserves: In the first, the supply is set in advance, while with the latter, it adjusts endogenously to market conditions.

It is worth emphasizing that the two tools can be mutually reinforcing in achieving desired outcomes. For example, lending facilities limit upward movements in interest rates on days of high demand, thereby reducing the ex ante supply of reserves needed to control short-term rates.⁴

Federal Reserve: Ample Reserves and Tools

The Fed’s operational framework has evolved over time, reflecting its experience with large balance sheets since the global financial crisis.⁵ In January 2019, when the decline in the Fed’s asset holdings implied that the quantity of reserves would soon fall below an “abundant” level, the FOMC formally adopted an ample reserves strategy.⁶

The FOMC has defined this framework as one in which “control over the level of the federal funds rate and other short-term interest rates is exercised primarily through the setting of the Federal Reserve’s administered rates, and in which active management of the supply of reserves is not required.”⁷ Accordingly, the ex ante supply of reserves is chosen to be sufficiently large to meet the demand for reserves on most days.

One important tool the FOMC has established to ensure interest rate control is the overnight reverse repo facility (ON RRP), which, alongside the interest paid on reserve balances (IORB), helps set a floor for the federal funds rate. Through the ON RRP, eligible counterparties “lend” to the Federal Reserve at the rate set by the FOMC, currently at the bottom of the target range for the federal funds rate. Usage of the ON RRP adjusts automatically to market conditions, rising and falling with supply and demand, which is particularly important in a dynamic market.

The ON RRP has proven to be a very effective and flexible tool to support interest rate control to the downside. When Federal Reserve asset holdings push reserves above ample, the ON RRP relaxes the tight relationship between balance sheet size and reserves and acts as a safety valve in supporting smooth transmission of monetary policy to markets. As the size of the balance sheet falls, market rates rise above the rate offered at the ON RRP and, as a result, usage of the ON RRP declines to very low levels. The dynamic usage of the ONRRP is seen in Figure 1, which shows average monthly usage of the ON RRP from 2016 through October of this year. The ON RRP was used extensively when it was economically sensible for the Fed’s counterparties to do so. By contrast, it has very limited usage when repo rates are well above the ON RRP rate, as is the case today.

In 2021, the Federal Reserve introduced the Standing Repo Facility (SRF), which nicely complements the ON RRP by providing interest rate control to the upside.⁸ The SRF rate is set at the top of the FOMC’s target range for the federal funds rate. This combination of an ample supply of reserves and an SRF rate at the top of the target range reduces the day-to-day reliance on the facility except during periods of significant upward pressure on rates resulting from strong liquidity demand or market stress.

By ensuring that adequate liquidity will be available in a wide variety of circumstances, the SRF plays a critical role in capping temporary upward pressure on rates and assures markets of effective interest rate control and smooth market functioning. It is best thought of as a way of making sure that the overall market has adequate liquidity consistent with the FOMC’s desired level of interest rates. In that regard, it differs from other lending facilities—such as the discount window—that aim to provide individual banks with liquidity when the need arises.

The SRF has been effective as reserves have moved from abundant toward ample. Over the past two months, SRF usage has risen from essentially zero to having greater frequency and higher volume of take-up, especially on days of temporary repo market pressures, as shown in Figure 2. Like the ON RRP facility, the SRF’s effectiveness relies on market participants availing themselves of the SRF based on market conditions, free of worries about stigma or other impediments. I fully expect that the SRF will continue to be actively used in this way and contain upward pressures on money market rates.

Federal Reserve: The Way Forward

At the onset of the pandemic, the Fed, along with central banks around the world, responded quickly to restore market functioning,⁹ causing reserves to rise well above ample, as they did in many jurisdictions.

In June of 2022, the Fed began the process of reducing the size of its balance sheet to transition toward an ample level of reserves.¹⁰ The FOMC said it intended to stop balance sheet runoff when it deemed reserves were somewhat above ample, and then allow reserves to decline further as other liabilities, such as currency, grow.

The process has worked according to plan. The Fed’s securities holdings have shrunk from a peak of about $8-1/2 trillion in 2022 to $6-1/4 trillion today. At its meeting in October, the FOMC decided it would conclude the reduction of its aggregate securities holdings on December 1.¹¹ This decision was based on clear market-based signs that we had met the test of reserves being somewhat above ample.¹² In particular, repo rates have increased relative to administered rates and have exhibited more volatility on certain days. Accordingly, we have been seeing more frequent use of the SRF. And the effective federal funds rate has increased somewhat relative to the IORB after years of that spread being at a stable level. These developments were expected as the supply of reserves closed in on ample.¹³

Looking forward, the next step in our balance sheet strategy will be to assess when the level of reserves has reached ample. It will then be time to begin the process of gradual purchases of assets that will maintain an ample level of reserves as the Fed’s other liabilities grow and underlying demand for reserves increases over time. Such reserve management purchases will represent the natural next stage of the implementation of the FOMC’s ample reserves strategy and in no way represent a change in the underlying stance of monetary policy.

Determining when we are at ample reserves is an inexact science. I am closely monitoring a variety of market indicators related to the fed funds market, repo market, and payments to help assess the state of reserve demand conditions. Based on recent sustained repo market pressures and other growing signs of reserves moving from abundant to ample, I expect that it will not be long before we reach ample reserves.

Conclusion

With that, we’ve arrived at the endgame of my remarks. We’ve learned a lot over the past decade. The FOMC’s monetary policy implementation framework is designed to support an adequate supply of liquidity under a wide range of circumstances. The combination of an ample supply of reserves and the Standing Repo Facility enables the Committee to maintain strong interest rate control and flexibility regarding changes in the size of its balance sheet. This operational framework has proven to be highly effective—and continues to work as designed.

Figures

How many pounds of rice do you think you eat in a year? According to USA Rice, the average American enjoys 27 pounds annually — equivalent to the weight of a case of bottled water. In fact, rice isn’t just a mainstay in pantries, it’s a staple for more than half the world, and a vital source of income for 19%¹ of the world’s population.

With extreme weather events—such as droughts, floods, pests, and diseases—threatening rice yields and demand for rice in the United States continuing to rise, it is crucial for industry leaders like Mars to advance supply chain resiliency strategies to secure the future of rice.

Rising to the Challenge: How Mars is Supporting Rice Farming Resilience
The Arkansas Delta is a region in the eastern part of Arkansas that stretches along the Mississippi River and is one of the most productive agricultural areas in the country. This area accounts for 49.3% of total U.S. rice production and 49.9% of the total acres planted in 2024². Today, its once-fertile fields are grappling with droughts, saltwater from rising sea levels and floods, among other challenges. These challenges all point to an urgent need for innovation to secure and maintain this essential crop’s environment — one grain at a time.

As the manufacturer of iconic brands like Ben’s Original™— one of the world’s most recognized rice brands — as well as Tasty Bite® and Seeds of Change™, Mars, the maker of more than 40 U.S. food, snacking and pet brands, deeply understands the role rice plays in kitchens across the U.S. and around the world. Rice is more than just a staple ingredient; it’s a cornerstone of culture and nourishment for more than four billion people worldwide. That’s why our role goes far beyond simply selling products — it’s about honoring rice’s global significance and supporting the communities, farmers and families who depend on it.

“As a leader in the rice industry, we recognize our opportunity to help farmers across our value chain address environmental challenges that threaten their livelihoods,” said Dave Dusangh, President Mars Food & Nutrition, North America. “By collaborating closely with our partner farmers, we are working to build a more sustainable, resilient and innovative rice supply chain that benefits both people and the planet.”

Innovating for a Water-Smart Future
We’re using our longstanding expertise and global resources to help farmers adopt and scale advanced agricultural techniques that conserve water while reducing greenhouse gas emissions.

Conventional rice cultivation often relies on continuously flooded fields, which is water intensive and restricts oxygen in the soil and creates conditions for methane-producing bacteria — leading to greenhouse gas emissions. Mars is helping farmers adopt innovative water management techniques and technologies that improve water efficiency, strengthen climate resilience, and cut emissions. A few of these examples include:

• Alternate wetting and drying (AWD): A water management technique that allows rice fields to alternate between periods of flooding and drying, rather than maintaining continuous flooding throughout the growing season. This approach has been shown to reduce the amount of water used by up to 30% and reduce the amount of GHG emissions produced by over 40%³ each growing season.
• Multiple inlet rice irrigation (MIRI): This system optimizes how water is delivered using multiple inlets in pipes placed across a field. This distributes water more efficiently, cutting down on water usage, and reducing emissions.
• Row rice, or furrow irrigation: A method that bypasses the need to flood fields, while improving ease of crop rotation. Using this technique, water is applied in rows rather than flooding across the entire section of the field.
• Zero-grade fields are precision-leveled to ensure a flat surface with no slope, allowing water to flow evenly across the field and eliminating the need for internal levees or side inlets. This minimizes the need for intensive tilling, further improving efficiency and enabling farmers to save up to 37%⁴ more water each growing season compared to traditional contoured or leveed fields.

While these are promising solutions, shifting away from traditional methods can be challenging. The cost of new systems, concern about potential yield loss and difficulty of changing longstanding habits all make adoption a challenge for many farmers. Mars is supporting farmers by paying premiums on top of the commodity price to incentivize the adoption of new practices, as well as sharing data so Mars can measure the environmental benefits of these practices. This data sharing has helped show farmers in the Mars rice supply chain that embracing these practices hasn’t negatively impacted their crop yields. In fact, research has shown that using zero-grade fields with the AWD irrigation method reduces water usage by 65%⁵ while still providing the same crop yields.

“The role Mars plays in helping us adopt climate-smart agriculture practices is critical because it gives us an incentive to go out there and try something new,” says Terry Gray, an Arkansas rice farmer in the Mars Food & Nutrition rice supply chain. “We’re trying out these practices to grow the same yields with less strain on the land — and the results are showing it’s better for the environment all around.”

Partnering to Protect Farmers and the Planet
“The challenges faced by rice farmers today demand bold leadership, and partners like Mars are vital in driving meaningful change,” said Peter Bachmann, President and CEO, USA Rice. “By leveraging its resources, expertise and scale, Mars is helping farmers adopt climate-smart agriculture practices that not only sustain their livelihoods but also safeguard the environment.”

At Mars, mutuality is one of our core guiding principles. Collaboration with partners throughout our supply chain is essential to how we’re working to shape a more secure future for farmers, communities and the planet. Our approach to rice farming reflects this value, as we address challenges and build the future we envision together, every step of the way.

Through a steadfast commitment to our Sustainable in a Generation plan, Mars is championing impactful innovation that strengthens U.S. rice farming, setting an example across global food systems in an ever-evolving world.
 

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1. Rice – Rice Sector at a Glance | Economic Research Service. n.d. https://www.ers.usda.gov/topics/crops/rice/rice-sector-at-a-glance

2. Handbook, IPM, AND-STaR | Arkansas Cooperative Extension Service https://www.uaex.uada.edu/farm-ranch/crops-commercial-horticulture/rice/

3. Mars & Riceland Sustainable Rice Program (Arva Intelligence)

4. Massey et al. 2022, Direct Comparisons of four rice irrigation systems on a commercial rice farm, Agricultural Water Management, Vol 266, 31 May 2022 https://www.sciencedirect.com/science/article/abs/pii/S0378377422001536

5. Mars & Riceland Sustainable Rice Program (Arva Intelligence)

New strategic alliance brings CrowdStrike Falcon Sensor and OverWatch Threat Hunting to F5 BIG-IP, free of charge through October 14, 2026

November 12, 2025 – SEATTLE and AUSTIN, Texas – F5 (NASDAQ: FFIV) and CrowdStrike (NASDAQ: CRWD) today announced a new strategic technology alliance and first-of-its-kind integration that brings advanced workload security to F5 BIG-IP. By enabling F5 customers to embed CrowdStrike’s Falcon Sensor directly into F5 BIG-IP and leverage CrowdStrike Falcon® Adversary OverWatch managed threat hunting service, the companies are advancing adaptive, AI-driven security to the network perimeter where enterprises front their most critical application and API traffic.

Extending detection and response beyond the endpoint

For years, the cybersecurity paradigm has centered on the edge as the primary battleground. Organizations rightly focused on securing laptops, desktops, and mobile devices with endpoint detection and response (EDR) software. This is crucial because these are the gateways through which users interact with corporate data and where many initial intrusions occur. However, attackers don’t stop at a compromised laptop; they see the entire network infrastructure as a sprawling set of cross-domain targets. To stop modern attacks, organizations need protection that extends beyond the endpoint – unifying visibility and defense across every domain that adversaries target.

“Today’s threat landscape demands taking the power of the Falcon platform beyond the endpoint,” said George Kurtz, CEO and founder of CrowdStrike. “We’re taking a bold step to move cybersecurity forward: normalizing the deployment of detection and response sensors across every attack surface, including network appliances. We’re pleased to take the first step by embedding CrowdStrike Falcon and OverWatch onto F5 BIG-IP. The Falcon platform has become essential for securing the modern enterprise.”

“For too long, network devices have lacked the same protection as other endpoints, even as they sit in front of the world’s most critical applications and APIs,” said François Locoh-Donou, President and CEO of F5. “The security incident we recently disclosed underscores how important it is to close this gap and continue raising the security bar across the industry. Delivered on the F5 Application Delivery and Security Platform (ADSP), CrowdStrike Falcon and OverWatch for BIG-IP brings AI-driven detection and threat hunting to the network edge. With over 200 customers already using Falcon for BIG-IP in their networks, our collaboration with CrowdStrike is enabling security teams to reduce blind spots and accelerate response times in their environments.”

CrowdStrike Falcon and OverWatch for F5 BIG-IP available now, free through October 14, 2026, to F5 customers

CrowdStrike Falcon Sensor and Overwatch Threat Hunting are available for BIG-IP Virtual Edition (VE) with availability on BIG-IP hardware systems by the end of the calendar year. F5 is providing eligible BIG-IP customers with complimentary access through October 14, 2026, to enable the immediate adoption of AI-native security and threat hunting at the network level without upfront costs. Interested F5 BIG-IP customers can view the Knowledge Base article or contact F5 for further information and assistance with onboarding.

Additional Resources:

To learn more, read the blog, watch the demo video, or visit the F5 and CrowdStrike partnership page.

About F5

F5, Inc. (NASDAQ: FFIV) is the global leader that delivers and secures every app. Backed by three decades of expertise, F5 has built the industry’s premier platform—F5 Application Delivery and Security Platform (ADSP)—to deliver and secure every app, every API, anywhere: on-premises, in the cloud, at the edge, and across hybrid, multicloud environments. F5 is committed to innovating and partnering with the world’s largest and most advanced organizations to deliver fast, available, and secure digital experiences. Together, we help each other thrive and bring a better digital world to life.

For more information visit f5.com

Explore F5 Labs threat research at f5.com/labs

Follow to learn more about F5, our partners, and technologies: Blog | LinkedIn | X | YouTube | Instagram | Facebook

F5 and BIG-IP are trademarks, service marks, or tradenames of F5, Inc., in the U.S. and other countries. All other product and company names herein may be trademarks of their respective owners. The use of the terms “partner,” “partners,” “partnership,” or “partnering” in this press release does not imply that a joint venture exists between F5 and any other company.

About CrowdStrike

CrowdStrike (NASDAQ: CRWD), a global cybersecurity leader, has redefined modern security with the world’s most advanced cloud-native platform for protecting critical areas of enterprise risk – endpoints and cloud workloads, identity and data.

Powered by the CrowdStrike Security Cloud and world-class AI, the CrowdStrike Falcon® platform leverages real-time indicators of attack, threat intelligence, evolving adversary tradecraft and enriched telemetry from across the enterprise to deliver hyper-accurate detections, automated protection and remediation, elite threat hunting and prioritized observability of vulnerabilities.

Purpose-built in the cloud with a single lightweight-agent architecture, the Falcon platform delivers rapid and scalable deployment, superior protection and performance, reduced complexity and immediate time-to-value.

CrowdStrike: We stop breaches.

Learn more: https://www.crowdstrike.com/

Follow us: Blog | X | LinkedIn | Instagram

Start a free trial today: https://www.crowdstrike.com/trial

# # #

This press release may contain forward looking statements relating to future events or future financial performance that involve risks and uncertainties. Such statements can be identified by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” or “continue,” or the negative of such terms or comparable terms. These statements are only predictions and actual results could differ materially from those anticipated in these statements based upon a number of factors including those identified in the company’s filings with the SEC.

Though she studied psychology in college, King fell in “love, love, love” with television news while working as a production assistant at a local CBS station and then committed to what would become a five-decade career in journalism. After stints producing, reporting for, and hosting local programs, she took to the national stage with her short-lived The Gayle King Show but soon found another home at the media company of her longtime friend Oprah Winfrey. Since 2012, she has anchored CBS Mornings, through changes in cohosts and, most recently, a management shake-up.

Picture an electric car that could go 600, 700 or even 1,000 miles on a single charge. That’s much farther than the longest-range electric vehicles on the U.S. market, according to Car and Driver magazine – and twice as far the official rating for the long-range, rear-wheel-drive Tesla Model 3, which has a maximum rated range of 363 miles.

Current EVs use lithium-ion batteries, which are also found in smartphones, laptops and even large-scale energy storage systems connected to the power grid. A standard for decades, these batteries have been tweaked and improved by generations of scientists and are now close to their physical limits. Even with the best materials and most optimized designs, there is only so much energy that can be packed into a lithium-ion battery.

I’m a materials engineer who studies these batteries and seeks alternatives with better performance, improved environmental sustainability and lower cost. One promising design uses sulfur, which could boost battery capacity significantly, though some key roadblocks remain before it can be widely used.

Lithium-sulfur vs. Lithium-ion

Any battery has three basic components: a positively charged region, called the cathode; a negatively charged region, called the anode; and a substance called the electrolyte in between, through which charged atoms, also known as ions, move between the cathode and anode.

In a lithium-ion battery, the cathode is made of a metal oxide, typically containing metals such as nickel, manganese and cobalt, bonded with oxygen. The materials are layered, with lithium ions physically between the layers. During charging, lithium ions detach from the layered cathode material and travel through the electrolyte to the anode.

The anode is usually graphite, which is also layered, with room for the lithium ions to fit between them. During discharge, the lithium ions leave the graphite layers, travel back through the electrolyte and reinsert into the layered cathode structure, recombining with the metal oxide to release electricity that powers cars and smartphones.

In a lithium-sulfur battery, the lithium ions still move back and forth, but the chemistry is different. Its cathode is made of sulfur embedded in a carbon matrix that conducts electricity, and the anode is made primarily of lithium itself, rather than graphite layers with lithium in between.

During discharging, the lithium ions travel from the anode, through the electrolyte to the cathode, where – rather than sliding in between the cathode layers – they chemically convert sulfur in sequential steps to a series of compounds called lithium sulfides. During charging, the lithium ions separate from the sulfide compounds, leave the cathode behind and travel back to the anode.

The charging and discharging process for lithium-sulfur batteries is a chemical conversion reaction that involves more electrons than the same process in lithium-ion batteries. That means a lithium-sulfur battery can theoretically store much more energy than a lithium-ion battery of the same size.

Sulfur is inexpensive and abundantly available worldwide, meaning battery manufacturers do not need to rely on scarce metals such as nickel and cobalt, which are unevenly distributed on Earth and often sourced from regions such as the Democratic Republic of Congo, which has limited worker safety regulations and fair labor practices.

Those advantages could deliver batteries with far more capacity and that are cheaper and more sustainable to produce.

Why aren’t lithium-sulfur batteries widely used yet?

The biggest obstacle to mass production and use of sulfur-based batteries is durability. A good lithium-ion battery, like those in an electric vehicle, can go through thousands of cycles of discharging and recharging before its capacity starts to fade. That amounts to thousands of car rides.

But lithium-sulfur batteries tend to lose capacity much more quickly, sometimes after fewer than 100 cycles. That’s not very many trips at all.

The reason lies in the chemistry. During the chemical reactions that store and release energy in a lithium-sulfur battery, some of the lithium sulfide compounds dissolve into the liquid electrolyte of the battery.

When that happens, those amounts of both sulfur and lithium are removed from being used in any remaining reactions. This effect, known as “shuttling,” means that with each round of discharging and recharging, there are fewer elements available to release and store energy.

In the past couple of decades, research has produced improved designs. Earlier versions of these batteries lost much of their capacity within a few dozen discharge–recharge cycles, and even the best laboratory prototypes struggled to survive beyond a few hundred.

New prototypes retain more than 80% of their initial capacity even after thousands of cycles. This improvement comes from redesigning the key parts of the battery and adjusting the chemicals involved: Special electrolytes help prevent the lithium sulfides from dissolving and shuttling.

The electrodes have also been improved, using materials such as porous carbon that can physically trap the intermediate lithium sulfides, stopping them from wandering away from the cathode. This helps the discharge and recharge reactions happen without so many losses, making the reactions more efficient so the battery lasts longer.

The road ahead

Lithium-sulfur batteries are no longer fragile laboratory curiosities, but there are significant challenges before they can become serious contenders for real-world energy storage.

In terms of safety, lithium-sulfur batteries have a less volatile cathode than lithium-ion batteries, but research is continuing into other aspects of safety.

Another problem is that the more energy a lithium-sulfur battery stores, the fewer cycles of charging it can handle. That’s because the chemical reactions involved are more intense with increased energy.

This trade-off may not be a major obstacle for using these batteries in drones or grid-level energy storage, where ultrahigh energy densities are less critical. But for electric vehicles, which demand both high energy capacity and long cycle life, scientists and battery researchers still need to sort out a workable balance. That means the foundation for the next generation of lithium-sulfur batteries is likely still a few years down the road.

– A total of 17 abstracts, including three accepted for presentation in the Cosmetic “Top Ten” Session, underscore Allergan Aesthetics’ global industry leadership across multiple aesthetic categories

– Oral abstract presentations include Phase 3 clinical study results for first-in-class botulinum neurotoxin serotype E (trenibotulinumtoxinE) and results from a Phase 4 study evaluating natural outcomes and patient satisfaction in a diverse population following use of 64 units of BOTOX® Cosmetic (onabotulinumtoxinA) for treatment of upper facial lines

– Expert panel discussion explores new Hyaluronic Acid Injectable Fillers Report, along with current use, facts, and real-world satisfaction data

IRVINE, Calif., Nov. 12, 2025 /PRNewswire/ — Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced it will present data highlighting efficacy, safety and patient-reported outcomes across its portfolio during the 2025 American Society of Dermatologic Surgery (ASDS) Annual Meeting, November 13-16, 2025, in Chicago, Illinois. Oral and video poster presentations, along with expert panels and symposiums, collectively demonstrate Allergan Aesthetics’ pioneering scientific research and innovation.

“Allergan Aesthetics leads the industry by consistently delivering clinically differentiated products to patients and providers through new indications and expanded uses for existing treatments, as well as novel investigational assets that meet the evolving needs of the market,” said John Maltman, vice president, global aesthetics medical affairs, Allergan Aesthetics.  “The scientific and clinical data reported at this year’s congress demonstrate how we continue to drive evidence-based innovation across our robust product portfolio, with the goal of improving the standard of care and personalized outcomes for all.”

Three abstracts were accepted for live presentation in the Cosmetic Oral Abstract Presentations: Top Ten Session where primary authors will present in-person on Thursday, November 13, at 10:45am CT:

• Safety and Efficacy of TrenibotulinumtoxinE for Treating Glabellar Lines in Toxin-Naïve Participants: Results from a Multicenter Phase 3 Study (presented by Rosalyn George, MD).
• Patient-Reported Satisfaction, Natural Look, and Improvement in Appearance-Related Psychological Impact from Fast-Acting TrenibotulinumtoxinE Treatment for Glabellar Lines: Phase 3 Study Results (presented by Robert Weiss, MD).
• High Patient Satisfaction with Natural-Looking Results after OnabotulinumtoxinA Treatment for Upper Facial Lines in a Diverse Population: A Phase IV, Open Label Multicenter Study (presented by Vince Bertucci, MD).

Allergan Aesthetics will also host two educational programs designed to explore patient needs and enhance clinical practice:   

• The Aesthetics Evolution: Redefining HA Fillers Through Education expert panel on Thursday, November 13, at 12:00pm CT will discuss insights from the recently published “Hyaluronic Acid Injectable Fillers Report” and provide education on the current use, facts, and real-world satisfaction data for hyaluronic acid (HA) injectable fillers. Panel participants include Dr. Sabrina Fabi, Dr. Terrence Keaney, Dr. Kavita Mariwalla, and Dr. Patricia Olgilvie and will be moderated by Melanie Rud.
• The One & Only BOTOX® Cosmetic symposium on Thursday, November 13, at 1:30pm CT will discuss the newest indication for BOTOX® Cosmetic, treatment for moderate to severe platysma bands, and associated clinical trials, injection paradigm, and live patient assessments. The session will be led by Dr. Sabrina Fabi and Dr. Patricia Ogilvie.

Other presentations from Allergan Aesthetics highlight new data on sequential administration of trenibotulinumtoxinE and BOTOX® Cosmetic for glabellar lines; the benefit of long-term, repeated use of BOTOX® Cosmetic for upper facial lines; the safety and effectiveness of SKINVIVE by JUVÉDERM® for the improvement of neck appearance; as well as survey results outlining facial and body aesthetic concerns and treatment trends following medical weight loss.

Additional details on Allergan Aesthetics’ video poster presentations are below. Video poster presentations will be available throughout the conference in the “Video Abstract Showcase” located in the exhibit hall. The full scientific program for ASDS 2025 is available here. Posters will also be available on the ASDS mobile app.

BOTOX^® Cosmetic (onabotulinumtoxinA) Important Information

Indications

BOTOX^® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
– Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
– Moderate to severe lateral canthal lines associated with orbicularis oculi activity
– Moderate to severe forehead lines associated with frontalis activity
– Moderate to severe platysma bands associated with platysma muscle activity

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING 

CONTRAINDICATIONS

BOTOX^® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

WARNINGS AND PRECAUTIONS
Lack of Equivalency Between Botulinum Toxin Products
The potency Units of BOTOX^® Cosmetic are specific to the preparation and assay method utilized. BOTOX^® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX^® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.

Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.

No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX^® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX^® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX^® to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX^®. The safety and effectiveness of BOTOX^® for unapproved uses have not been established.

Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of BOTOX Cosmetic and immediately institute appropriate medical therapy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.

Cardiovascular System
There have been reports following administration of BOTOX^® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including preexisting cardiovascular disease. Use caution when administering to patients with preexisting cardiovascular disease.

Increased Risk of Clinically Significant Effects With Preexisting Neuromuscular Disorders
Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions). Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin.

Dysphagia and Breathing Difficulties
Treatment with BOTOX^® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).

Preexisting Conditions at the Injection Site
Use caution when BOTOX^® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Dry Eye in Patients Treated With BOTOX^® Cosmetic
There have been reports of dry eye associated with BOTOX^® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.

Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), which would also be considered remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX^® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).

The most frequently reported adverse reaction following injection of BOTOX^® Cosmetic for lateral canthal lines was eyelid edema (1%).

The most frequently reported adverse reactions following injection of BOTOX^® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).

The safety profile of BOTOX^® Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX^® Cosmetic for other indications.

DRUG INTERACTIONS
Coadministration of BOTOX^® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX^® Cosmetic may potentiate systemic anticholinergic effects.

The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX^® Cosmetic.

USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX^® Cosmetic in pregnant women. There are no data on the presence of BOTOX^® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.

Please see BOTOX^® Cosmetic full Prescribing Information, including Boxed Warning and Medication Guide.

SKINVIVE by JUVÉDERM® Injectable Gel Important Information

INDICATIONS
SKINVIVE by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Not for patients with a history of anaphylaxis, presence of multiple severe allergies, or allergies to Gram-positive bacterial proteins or lidocaine in this product.

WARNINGS: Do not inject into blood vessels as this may lead to embolization, occlusion of the vessels, ischemia, or infarction. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention should an intravascular injection occur. Treatment at specific sites should be deferred where there is an active inflammatory process or infection.

PRECAUTIONS: Only healthcare professionals who have appropriate training, experience, and are knowledgeable of the anatomy at and around the injection site should use this product. As with all transcutaneous procedures, injections carry a risk of infection. The safety for use during pregnancy, breastfeeding, and in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been established. Use with caution in patients on immunosuppressive therapy. Patients taking medications that can prolong bleeding may experience increased bruising or bleeding at treatment sites. Patients may experience late onset AEs with use of injectable gel implants, including SKINVIVE by JUVÉDERM®

ADVERSE EVENTS: The most commonly reported injection site responses included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most were mild, lasting 7 days or less.

Please see Directions for Use or visit SKINVIVE.com for more information.

SKINVIVE by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.

The investigational products described above, trenibotulinumtoxinE for the treatment of glabellar lines and SKINVIVE by JUVÉDERM® for the improvement of neck appearance, have not yet been shown to be safe and effective for their intended uses.

About Allergan Aesthetics

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube.

Forward-Looking Statements 

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

 

 

SOURCE AbbVie

Company reports progress to file planned IND for (Z)-endoxifen in mBC with CRO selection and streamlined development programs for potential 2026-NDA enabling activities, including a Type C meeting with the FDA, to potentially accelerate (Z)-endoxifen in breast cancer risk reduction

Appointed key leadership to drive (Z)-endoxifen development and evolve pathway to commercialization

SEATTLE, Nov. 12, 2025 /PRNewswire/ — Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing proprietary innovative medicines in areas of significant unmet medical need in oncology, today announces its financial results for the third quarter ended September 30, 2025 and provides an update on recent corporate developments.

“We continue to make meaningful and measurable progress across our (Z)-endoxifen development strategy in oncology,” stated Dr. Steven Quay, Atossa Therapeutics’ Chairman and CEO. “Initiatives include enhanced efficiency, focus and financial discipline with our programs, and readiness as we work to evolve into a commercial company. With a strong balance sheet, a strategically focused team, and the true desire to provide a solution for the millions of women worldwide suffering from breast cancer, we believe we are well-positioned to execute on our planned upcoming IND submission and advance our clinical programs toward key value-creating milestones.”

Clinical & Regulatory Developments

• Requested a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss regulatory strategy aimed at accelerating development of (Z)-endoxifen in breast cancer risk reduction – In September 2025, Atossa requested a Type C meeting with the FDA to discuss a regulatory strategy aimed at accelerating development of low-dose (Z)-endoxifen for breast cancer risk reduction. On November 6, 2025, Atossa received preliminary written comments from the FDA regarding the regulatory path for (Z)-endoxifen. The Company expects to meet with the FDA on November 17, 2025, to discuss a development plan intended to support filing an NDA, including the potential use of expedited programs where eligible. Atossa will evaluate any implications for its plans and timelines following receipt of FDA meeting minutes, which are expected to be available in December 2025.  This follows the recommendation of Atossa’s team of experts — including an internationally recognized FDA law firm and senior regulatory affairs experts — engaged to review the Company’s extensive (Z)-endoxifen data and the considerable published scientific literature on (Z)-endoxifen to evaluate whether existing evidence could support a faster regulatory path in breast cancer risk-reduction. Atossa has now filed this meeting request to align with the FDA on the requirements needed to complete a New Drug Application (NDA) and expects to update shareholders on the outcome of the meeting before year end 2025, based on standard agency timelines and subject to a timely resolution to the ongoing U.S. government shutdown. While there can be no assurance of a favorable outcome, a successful alignment with the FDA could materially shorten development timelines and reduce future clinical costs.
• Streamlined EVANGELINE breast cancer clinical trial to prioritize potential 2026 NDA-enabling activities – In October 2025, Atossa amended its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal women with newly diagnosed early-stage ER+/HER2- breast cancer. The amended, non-registrational study design is expected to accelerate objective readouts while reducing projected future study costs, consistent with Atossa’s focus on extending operating runway and deploying capital where it is most impactful. In 2026, Atossa plans to concentrate its resources on near-term, NDA-enabling activities for investigational (Z)-endoxifen.
• Named Janet R. Rea, MSPH, as Senior Vice President, R&D to accelerate (Z)-endoxifen toward key regulatory milestones. Appointed Mark Daniel, CPA, as Chief Financial Officer to lead finance, systems, and capital strategy for commercial readiness – In October 2025, Atossa appointed Janet R. Rea, MSPH to its newly created position Senior Vice President, R&D. Ms. Rea brings more than two decades of strategic research and clinical development expertise, with a success record for regulatory approvals, to oversee late-stage (Z)-endoxifen programs with near term priorities that include planned upcoming FDA submissions, interactions, and defining a pathway to commercialization. Also in October 2025, Atossa named Mark Daniel, CPA (WA; inactive), as Chief Financial Officer. Mr. Daniel is a senior finance leader with more than 25 years of experience building the forecasting cadence, systems, and public-company discipline that support revenue scale in global life-science businesses. He has overseen weekly revenue forecasting in partnership with commercial leadership, managed operating expense budgets exceeding $200 million, implemented and certified Sarbanes-Oxley (SOX) controls, and led programs delivering over $50 million in cost savings.
• Selected PSI as Contract Research Organization (CRO) for planned pivotal dose ranging study of (Z)-endoxifen in metastatic breast cancer (mBC) – In August 2025, Atossa selected PSI, a leading global CRO, to operationalize and manage its planned (Z)-endoxifen monotherapy dose-ranging study in women with mBC. The study was designed following guidance from the FDA and is intended to directly inform a subsequent Phase 3 trial. The global Phase 2, multi-center dose-ranging study is designed to evaluate (Z)-endoxifen monotherapy for safety, pharmacokinetics/pharmacodynamics, and preliminary anti-tumor activity. Patient enrollment is expected to follow the planned Investigational New Drug (IND) filing in Q4 2025, with topline data anticipated in 2026.
• Highlighted progress in RECAST™ DCIS platform trial – In October 2025, Atossa announced that Laura J. Esserman, MD, MBA, Professor of Surgery and Radiology at the University of California, San Francisco and Principal Investigator of RECAST™, will speak at the Early Detection Research Conference in Portland, OR, about the Company’s collaborative work in the RECAST platform trial for ductal carcinoma in situ (DCIS), a biologically heterogeneous, non-invasive breast condition that can progress to invasive breast cancer in a subset of patients. DCIS represents a large, under-served market that is commonly treated like invasive cancer (surgery ± radiation ± endocrine therapy). Demonstrating that a biomarker-guided, non-surgical approach is safe and effective could potentially reshape standard of care and expand use of oral endocrine agents in early-stage disease management. The platform design enables parallel testing of multiple agents, including Atossa’s (Z)-endoxifen, with common imaging and biomarker endpoints to generate comparative signals that can inform registration strategies. The Company believes that early imaging response, biomarker correlation, and active-surveillance suitability rates by arm create interim readout opportunities that can help de-risk later-stage programs and guide payer-relevant health-economic modeling. RECAST is sponsored by Quantum Leap Healthcare Collaborative with research support from NIH and industry partners. This shared-infrastructure model can help accelerate enrollment, broaden site access, and optimize capital efficiency.

Intellectual Property & Patent Portfolio

• New Israel Patent – In October 2025, Atossa announced key progress in its global intellectual-property strategy for (Z)-endoxifen, including the issuance of an Israeli patent and continued patent renewals that reinforce protection for the Company’s lead program across major jurisdictions. The Israeli patent (No. 304863), titled, “Methods for Making and Using Endoxifen,” was granted on July 2, 2025, with priority to multiple U.S. provisional applications filed in 2017–2018.
• Recent Patent Challenges – Two of Atossa’s patents are currently the subject of post–grant challenges (i.e., U.S. Patent Nos. 11,261,151 and 12,071,391), which may result in modification or invalidation of certain patent claims; however, such proceedings are common for high–value pharmaceutical IP, and we remain confident in our ability to vigorously defend these patents. The majority of Atossa’s intellectual property is unaffected. Atossa holds four additional issued U.S. patents with claims to endoxifen—U.S. Patent Nos. 11,680,036, 12,201,591, 12,275,684, and 12,281,056—with over 200 total claims covering proprietary manufacturing methods, stable crystalline forms, and multiple sustained–release and enteric oral formulations of (Z)–endoxifen. We believe that these patents, along with pending applications worldwide, provide substantial additional protection for our lead program.

Strategic Outlook & Upcoming Milestones

Atossa remains focused on executing its breast cancer development strategy. Key upcoming deliverables include:

• Working with the FDA on regulatory strategies for breast cancer indications beyond metastatic breast cancer, including women in the adjuvant setting, patients with DCIS, and use in reducing the incidence of breast cancer in high-risk women.
• Targeting potential IND submission in Q4 2025, in alignment with feedback under the FDA Project Optimus initiative.
• Advancing enrollment and data generation from ongoing Phase 2 trials.

Comparison of Three and Nine Months Ended September 30, 2025 and 2024 

Operating Expenses. Total operating expenses were $9.3 million and $25.7 million for the three and nine months ended September 30, 2025, respectively, which was an increase of $2.9 million and $5.2 million from total operating expenses for the three and nine months ended September 30, 2024 of $6.4 million and $20.5 million, respectively. Factors contributing to the increased operating expenses in the three and nine months ended September 30, 2025 are explained below.

Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three and nine months ended September 30, 2025 and 2024, together with the dollar change and percentage change in those categories (dollars in thousands):

As (Z)-endoxifen is our only product candidate for which we currently incur R&D expenses, we have not further disaggregated R&D expenses by product candidate:

• Clinical and non-clinical trial expenses increased $1.8 million and $3.3 million for the three and nine months ended September 30, 2025, respectively, compared to the three and nine months ended September 30, 2024, due to increases in spend related to our (Z)-endoxifen trials, including drug development costs.
• The increase in R&D compensation expenses of $0.5 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024, was primarily due to an increase in headcount. R&D compensation expense remained relatively flat for the three months ended September 30, 2025, compared to the same period in 2024.
• The increases in R&D professional fees and other of $0.1 million and $0.6 million for the three and nine months ended September 30, 2025, respectively, compared to the three and nine months ended September 30, 2024, were primarily attributable to higher regulatory consulting fees in the 2025 periods related to our (Z)-endoxifen program.

General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three and nine months ended September 30, 2025 and 2024, together with the dollar change and percentage change in those categories (dollars in thousands):

• The increases in G&A compensation expenses of $0.1 million and $0.8 million for the three and nine months ended September 30, 2025, respectively, compared to the three and nine months ended September 30, 2024, were primarily due to increases in non-cash stock-based compensation expense of $0.1 million and $0.6 million, respectively.
• The increases in G&A professional fees and other of $0.8 million and $0.3 million for the three and nine months ended September 30, 2025, compared to the three and nine months ended September 30, 2024, were primarily due to increases in legal fees of $0.7 million and $0.5 million, respectively, related to higher patent-related activity as well as other legal matters, partially offset by decreases in investor relations costs of $0.3 million due to changes in the timing of investor outreach programs.

Interest Income. Interest income was $0.6 million and $1.9 million for the three and nine months ended September 30, 2025, respectively, a decrease of $0.4 million and $1.3 million from interest income of $1.0 million and $3.2 million for the three and nine months ended September 30, 2024, respectively. The decreases were due to decreases in the average balance invested in our money market account.

Impairment Charge on Investment in Equity Securities. For the nine months ended September 30, 2024, we wrote down our Investment in equity securities by $1.7 million due to the impairment of our investment in Dynamic Cell Therapies, Inc. (DCT).

About (Z)-endoxifen
(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated ability to inhibit and potentially degrade estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets the oncogenic signaling pathway, protein kinase C beta 1 (PKCβ1), at clinically achievable blood and tumor levels. (Z)-endoxifen also seems to deliver comparable or superior bone-protective effects relative to tamoxifen.

Atossa is developing a proprietary enteric oral formulation of (Z)-endoxifen that bypasses stomach acid, which would otherwise partially convert the active (Z)-isomer to its inactive (E)-form. We believe this innovation allows for optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa’s (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. In over 700 subjects (healthy volunteers and breast cancer patients) receiving doses up to 360 mg/day, no maximum tolerated dose (MTD) has been identified, supporting continued dose-range exploration.

Atossa is actively pursuing what it believes are opportunities to accelerate its regulatory path with (Z)-endoxifen for use in several indications in which low dose (Z)-endoxifen could potentially help lower the risk of breast cancer. We expect to share more about the viability of this accelerated path and related milestones by the end of 2025. In addition, Atossa is continuing its ongoing development efforts for use of (Z)-endoxifen in metastatic breast cancer. The compound is currently being evaluated in three Phase 2 studies, one in DCIS and two in ER+/HER2- breast cancer. Further, monotherapy in DCIS and low risk cancer, and combination therapy in high-risk cancer, with Lilly’s CDK4/6 inhibitor, Verzenio® (abemaciclib), are being investigated. Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including three recently issued U.S. patents and numerous pending applications worldwide.

About Atossa Therapeutics
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing novel therapies in oncology, including (Z)-endoxifen, to improve outcomes for patients across the breast cancer continuum of care. Information about Atossa can be found at the website: https://atossatherapeutics.com/.

Forward Looking Statements

This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate,” “believe,” “design,” “predict,” “future,” or other comparable words. All statements made in this press release that are not statements of historical fact, including statements regarding the Company’s development strategy and related milestones, data related to the (Z)-endoxifen program, the safety, tolerability and efficacy of (Z)-endoxifen, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval, including potential IND and NDA submissions, and related timing, benefits of the Company’s strategy of pursuing a metastatic indication for (Z)-endoxifen, the expected design and enrollment of trials and timing of data and related publications, the Company’s progress across its pipeline, the strength of the Company’s patent portfolio and expectations regarding related litigation, and the potential market and growth opportunities for the Company, are forward-looking statements. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, to differ materially from those projected or anticipated, including risks and uncertainties associated with: our ability to successfully execute our strategy to pursue a metastatic breast cancer indication for our lead program, (Z)-endoxifen, and to develop in parallel low dose (Z)-endoxifen for breast cancer reduction; our ability to shorten our clinical development timelines and reduce future clinical development costs through an accelerated path to filing an NDA, which is dependent on the timing and outcomes of submissions to and other interactions with the U.S. Food and Drug Administration (FDA); the expected timing of releasing data; any variation between interim or preliminary and final clinical results or analysis; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to regain compliance or maintain compliance with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.

SOURCE Atossa Therapeutics Inc

UAE-based PTA Global Holding Limited has acquired a majority stake in Lotte Chemical Pakistan Limited.

According to a filing with the Pakistan Stock Exchange (PSX), PTA Global Holding Limited has acquired a total of 1,192,292,329 ordinary shares, representing approximately 78.74% of the company’s issued and paid-up capital.

The acquisition includes 1.13 million shares (around 75.01%) purchased from Lotte Chemical Corporation, South Korea, and an additional 56.43 million shares (3.73%) acquired through a mandatory public offer to remaining shareholders under the Securities Act, 2015.

With the completion of this transaction, Lotte Chemical Corporation has fully divested its shareholding in the Pakistani entity, ending its ownership in Lotte Chemical Pakistan.

Following the acquisition, major changes have been made to the company’s leadership. The outgoing directors Jo Hyun Kwoun, Young Dae Kim, Seong Jun Park, Jae Sun Park, Cheolsoo Kim, Rashid Ibrahim, and Khurram Rashid have resigned from the board effective November 12, 2025.

To fill the resulting vacancies, the board appointed Imtiaz Ahmed, Adnan Afridi, Muhammad Zahoor Ilahee Cheema, Fehmina Khan, Faisal Ahmed Siddiqui, Osman Asghar Khan, and Shahid Ul Hassan Chattha as new directors.

Additionally, Imtiaz Ahmed has been appointed Chairman of the Board, succeeding Jo Hyun Kwoun, while Adnan Afridi has been named Chief Executive Officer, replacing Young Dae Kim. Both appointments took effect immediately on November 12, 2025.

As part of the leadership overhaul, the Audit Committee, HR and Remuneration Committee, and Share Sub-Committee have also been reconstituted in line with the new board structure.