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November 7, 2026 10:53 am

QumulusAI to Report Third Quarter 2026 Financial Results on Nov. 10, 2026

QumulusAI to Report Third Quarter 2026 Financial Results on Nov. 10, 2026

The company will host a conference call and webcast at 5 p.m. EST the same day to discuss results for the quarter ended Sept. 30, 2026.

ATLANTA–(BUSINESS WIRE)–
QumulusAI (Nasdaq: QMLS), a neocloud infrastructure provider purpose-built for the AI computing era, today announced that it will report financial results for the third quarter ended Sept. 30, 2026 after market close on Tuesday, Nov. 10, 2026, and will host a conference call and webcast at 5 p.m. EST the same day to discuss the results.

Conference Call and Webcast Details

Date: Nov. 10, 2026

Time: 5 p.m. EST

Webcast: https://events.q4inc.com/attendee/828550480

Domestic dial-in: +1 833-461-5787

International dial-in: +1 585-542-9983

Meeting ID: 828 550 480

Participants are encouraged to join 10 minutes before the call starts. A live webcast and an archived replay will be available in the Investor Relations section of the company’s website at investors.qumulusai.com.

About QumulusAI

QumulusAI is a distributed AI cloud platform that delivers accelerated access to high-performance GPU compute. Through an inference-first, demand-led deployment model across a network of data center sites, QumulusAI brings compute closer to customer demand, helping AI teams and enterprises scale production AI workloads with speed, flexibility and control. By combining rapid deployment with flexible private cloud infrastructure, QumulusAI gives customers a faster, more adaptable path beyond the capacity constraints of traditional centralized and hyperscale cloud models. Learn more at QumulusAI.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261107613789/en/

Investor Contact

[email protected]

Media Contact

[email protected]

KEYWORDS: Georgia United States North America

INDUSTRY KEYWORDS: Data Management Semiconductor Technology Other Technology Software Networks Artificial Intelligence

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November 7, 2026 10:04 am

argenx Presents Phase 3 ALKIVIA Data at ACR Convergence 2026 Showing Rapid and Sustained Improvement with Efgartigimod in Autoimmune Myositis

ALKIVIA met its primary and key secondary endpoints in the combined IMNM and DM population
First Phase 3 study to demonstrate statistically significant and clinically meaningful benefit in IMNM, an autoimmune myositis subtype with no approved therapies
Consistent, clinically meaningful treatment effect in DM, demonstrating improvements in muscle strength and skin disease activity

November 7, 2026, 10:00 AM ET

Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), the immunology innovation company, today announced that data from the Phase 3 ALKIVIA study demonstrating rapid and sustained improvement with VYVGART^® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in patients with autoimmune myositis will be featured in a late-breaking oral presentation (#LB24) at the American College of Rheumatology (ACR) Convergence 2026 on November 11, 2026, from 9:15-9:30 a.m. ET.

Combined IMNM and DM population: Primary and key secondary endpoints met

The study met its primary endpoint in the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) patient population, demonstrating that patients treated with efgartigimod achieved a statistically significant and clinically meaningful 15.4-point greater improvement in mean Total Improvement Score (TIS) at Week 52 versus placebo (p=0.0011; 48.0 vs 32.6). The study also met key secondary endpoints in the combined population, including response rate, time to response, muscle strength, and disease activity.

Efgartigimod was generally well tolerated by patients. The observed safety profile was consistent with prior studies and the known safety profile of efgartigimod.

“These Phase 3 results add to the growing body of evidence that targeting FcRn delivers a meaningful, sustained benefit for people with autoimmune myositis,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “ALKIVIA demonstrates the clinical relevance of reducing pathogenic autoantibodies, strengthening the case for efgartigimod to be the first targeted treatment for IMNM. We are moving with urgency to bring efgartigimod to people living with IMNM, who have no approved treatments, and we remain committed to advancing efgartigimod for people living with DM.”

IMNM: Rapid, sustained improvement supports potential first approved treatment

IMNM patients treated with efgartigimod demonstrated a clinically meaningful 14.8-point greater improvement in mean TIS versus placebo at Week 52 (p=0.0048; 45.1 vs 30.2).

Early, durable response: A greater proportion of patients treated with efgartigimod achieved a mean TIS of 40 or more (TIS ≥ 40) at Week 52 versus those on placebo (22.0 percentage-point difference) and were twice as likely to maintain that response through Week 52.
Greater muscle strength: Patients treated with efgartigimod experienced greater improvement (5.4 points) versus placebo in Manual Muscle Testing-8 (MMT-8), which evaluates strength across eight muscle groups.
Reduced muscle injury: Creatine kinase (CK) levels decreased rapidly in patients treated with efgartigimod and remained lower through Week 52, with a 43.5 percentage-point greater reduction from baseline versus placebo, as well as greater improvement in CK grade (0.9-grade greater reduction). CK is a key biomarker of active muscle injury.
Improvements in disease activity: Patients and physicians both reported greater improvement in disease activity with efgartigimod versus placebo at Week 52 as measured by the Patient Global Assessment of Disease Activity (PGA) and Physician Global Assessment of Disease Activity (MDGA).

Based on the ALKIVIA results, argenx plans to submit a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for efgartigimod in IMNM by the end of 2026, supported by a Breakthrough Therapy Designation from the FDA.

DM: Clinically meaningful treatment effect supports targeting FcRn

In the DM patient population, a clinically meaningful 14.5-point greater improvement versus placebo in mean TIS at Week 52 was observed (p=0.1093; 51.5 vs 37.0), though statistical significance was not reached in this smaller cohort.

Early, sustained response: A greater proportion of patients treated with efgartigimod achieved TIS ≥ 40 versus placebo (27.2 percentage-point difference). Separation from placebo patients was evident from Week 4 and maintained through Week 52.
Improved skin disease: Patients treated with efgartigimod showed a clear improvement in skin disease severity (5.6-point greater improvement at Week 52) versus placebo, as measured by the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), with improvement seen from Week 4.
Improved disease activity: Patients and physicians both reported greater improvement in disease activity with efgartigimod versus placebo at Week 52, as measured by the PGA and MDGA.

More information on the data presented at the ACR Convergence 2026 Annual Meeting can be found here.

About the ALKIVIA Study

The ALKIVIA study was a global, randomized, double-blind, placebo-controlled, multicenter, operationally seamless Phase 2/3 study of efgartigimod SC for the treatment of autoimmune myositis across immune-mediated necrotizing myopathy (IMNM), dermatomyositis (DM) and polymyositis (PM). The ALKIVIA study randomized 265 patients who had active disease and were on background treatment. Participants were randomized (1:1) to receive weekly injections of efgartigimod PH20 SC or matched placebo PH20 SC. The study was conducted in two phases, with an analysis of the Phase 2 portion of the clinical trial after the first 89 patients completed the study, followed by Phase 3. In the Phase 3 study, 175 patients received treatment. The Phase 3 study included a protocol-mandated corticosteroid taper throughout the study. The primary endpoint of Phase 3 was the mean Total Improvement Score (TIS) at the end of the treatment period of 52 weeks of all treated patients compared to placebo. Prespecified analyses evaluated the combined IMNM and DM population and each subtype separately.

ALKIVIA was conducted globally across North and South America, Europe, and Asia-Pacific, including China and Japan. argenx has an exclusive license agreement with Zai Lab for the development and commercialization of VYVGART and VYVGART Hytrulo in Greater China. Through this agreement, Zai Lab recruited Chinese patients into the ALKIVIA trial.

About Autoimmune Myositis
Autoimmune myositis is a heterogenous disease spectrum with autoimmune-mediated pathophysiology, characterized by chronic inflammation and progressive muscle weakness, and in some subtypes by skin involvement and other extramuscular manifestations. Proximal muscle weakness is a hallmark clinical feature across subtypes.

Approximately 100,000 people in the United States live with autoimmune myositis, including approximately 20,000 with immune-mediated necrotizing myopathy (IMNM) and approximately 40,000 with dermatomyositis (DM). Up to 80% of patients report long-term disability despite treatment. There are currently no selectively targeted treatments available, and care and treatment relies primarily on corticosteroids and broad immunosuppressants, which are associated with significant cumulative toxicity, including metabolic, cardiovascular, musculoskeletal and infectious complications.

Advances in the understanding of autoimmune myositis biology have highlighted the central role of antibody-mediated immunity, with pathogenic IgG autoantibodies contributing to muscle fiber damage and extramuscular manifestations across subtypes. FcRn maintains circulating IgG levels by recycling IgG antibodies, including pathogenic autoantibodies.

About Immune-mediated Necrotizing Myopathy

Immune-mediated necrotizing myopathy (IMNM) is a subtype of autoimmune myositis and is characterized as a sudden and severe loss of muscle strength, progressing to difficulty walking, lifting arms, or maintaining independent mobility. The rapid onset and aggressive nature of the disease can often lead to hospitalization, intensive treatment, and reliance on caregivers, which can make the patient experience acute and destabilizing. As the disease progresses, healthy muscle tissue is permanently replaced by fat and scar tissue. Approximately 20,000 IMNM patients are diagnosed in the U.S.

About Dermatomyositis

Dermatomyositis (DM) is a subtype of autoimmune myositis and is characterized as muscle weakness and distinctive skin rashes that can be painful, itchy, or highly visible on the face, chest, and hands. DM can also be associated with rapidly progressive interstitial lung disease and is strongly associated with malignancy. Some patients have reported increased self-consciousness, stigma, and social withdrawal, making the emotional burden more pronounced. Approximately 40,000 DM patients are diagnosed in the U.S.

About Efgartigimod and Efgartigimod SC

Efgartigimod (efgartigimod alfa fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and for primary immune thrombocytopenia (ITP) in Japan. Efgartigimod SC is a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE^® drug delivery technology to facilitate subcutaneous injection delivery of biologics.

What is VYVGART HYTRULO
^®
(efgartigimod alfa and hyaluronidase-qvfc)?

VYVGART HYTRULO is a prescription medicine used to treat adults with:

generalized myasthenia gravis (gMG)
chronic inflammatory demyelinating polyneuropathy (CIDP)

It is not known if VYVGART HYTRULO is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

Before taking VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:

have an infection or fever.
have recently received or are scheduled to receive any vaccinations.
have any history of allergic reactions.
have kidney (renal) problems.
are pregnant or plan to become pregnant. It is not known whether VYVGART HYTRULO will harm your unborn baby.
- Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com
are breastfeeding or plan to breastfeed. It is not known if VYVGART HYTRULO passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

VYVGART HYTRULO can cause side effects which can be serious, including:

Infection. VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection:

fever	pain and blockage of nasal passages	sore throat
chills	wheezing	excess phlegm
frequent and painful urination	shortness of breath	nasal discharge
cough

Allergic reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:

rash	trouble breathing
swelling of the face, lips, throat, or tongue	low blood pressure
shortness of breath	fainting
hives

Infusion or injection-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction:

high blood pressure	shivering
chills	chest, stomach, or back pain

The most common side effects of VYVGART HYTRULO include respiratory tract infection, headache, urinary tract infection, and injection site reactions.

These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information for VYVGART and full Prescribing Information for VYVGART HYTRULO.

About argenx
argenx is the immunology innovation company, focused on turning immunology breakthroughs into medicines for patients. The company seeks novel biology wherever it emerges, co-creating with academic researchers through its Immunology Innovation Program (IIP) and investing in promising science, to develop treatments for people living with underserved diseases. By advancing molecules with the potential to reach multiple diseases and patient populations, argenx is building a world-class portfolio. This approach produced the first approved antibody fragment targeting the neonatal Fc receptor (FcRn) and today powers a growing pipeline of early and late-stage programs across several therapeutic areas. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube.

Media:
Kate Dion
[email protected]

Colin McBean
[email protected]

Investors:
Alexandra Roy
[email protected]

FORWARD LOOKING STATEMENTS
The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements generally can be identified by the use of forward-looking words, such as “aim”, “anticipate”, “aspire”, “believe”, “can”, “continue”, “could”, “estimate”, “expect”, “entail”, “forecast”, “future”, “goals”, “hope”, “intend”, “is designed to”, “likely”, “may”, “might”, “objective”, “plan”, “possible”, “potential”, “pursue”, “project”, “predict”, “seek”, “should”, “strategy”, “target”, “will” and other words and terms of similar meaning and expression, including in connection with any discussion of future operating or financial performance. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx’s clinical trials; uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development risks and setbacks; interpretation of argenx’s clinical trial data by regulatory authorities and argenx’s ability to obtain regulatory approval; the risk that early stage clinical trials may not be predictive of results in later stage or large scale clinical trials; the occurrence of adverse safety events or participant dropouts; the acceptance of its products and product candidates by its patients as safe, effective, and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; the impact of healthcare regulations, including rules on reimbursement for argenx’s products; competition in drug discovery, development and commercialization efforts; its reliance on third-party suppliers, service providers and manufacturers; and instability and conflicts in the regions in which the company has suppliers or markets for its products. A further list and description of these and other risks, uncertainties, and factors that could cause actual results to differ materially from those referred to in the forward-looking statements can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these risks and uncertainties, the reader is advised not to place undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this press release. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

November 7, 2026 10:03 am

New Real-World Evidence Presented by Organon at the American College of Rheumatology (ACR) Annual Meeting Evaluated a Large-Scale Switch to HADLIMA® (adalimumab-bwwd) Across United States Veterans Affairs Healthcare System

New Real-World Evidence Presented by Organon at the American College of Rheumatology (ACR) Annual Meeting Evaluated a Large-Scale Switch to HADLIMA^® (adalimumab-bwwd) Across United States Veterans Affairs Healthcare System

Analysis of over 16,000 patients switched to HADLIMA^® from HUMIRA^® (adalimumab) showed a 1.3% switchback rate over a 12-month follow-up period¹
Data demonstrated the switching cohort had an average first-year per-patient pharmacy cost decrease of $8,100 across all indications in the analysis¹
The switch resulted in $132 million total estimated savings to the Veterans Affairs Healthcare System¹

JERSEY CITY, N.J.–(BUSINESS WIRE)–
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the poster presentation of new real-world evidence at the American College of Rheumatology (ACR) Annual Meeting, held November 6-11, 2026 in Orlando, Florida. The poster evaluates the treatment, management, and economic impacts of transitioning patients from originator HUMIRA^® (adalimumab) to biosimilar HADLIMA^® (adalimumab-bwwd) within the United States (US) Department of Veterans Affairs (VA) Healthcare System.¹

The analysis demonstrated that a large-scale health system switch to HADLIMA was achieved with a 1.3% switchback rate over a 12-month follow-up period.¹ Though published rates vary, switchback rates from biosimilars to originator are frequently cited as 16-18% in the scientific literature.^2,3 Adherence metrics remained similar pre- and post-switch while generating cost savings for the healthcare system, with average per-patient pharmacy costs decreasing by $8,100 in the first year following the switch.¹ HADLIMA was exclusively selected by the VA to replace HUMIRA on its national formulary in 2024.⁴

“The findings demonstrate that a well-managed formulary transition to HADLIMA can deliver both continuity of care and economic savings,” said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon. “Real-world evidence at this scale is critical for showing that biosimilar adoption can support sustainable health systems while delivering confidence to doctors and patients alike. At Organon, we believe in the potential of biosimilars to expand patient access to effective treatments while potentially reducing the affordability burden on health care systems.”

The study analyzed electronic health records and administrative datasets from the Veterans Health Administration (VHA) Corporate Data Warehouse, including veterans who received any adalimumab treatment between October 1, 2015, and August 1, 2025, with at least one baseline clinical encounter.^1* Patients were categorized into three cohorts: originator HUMIRA only, HADLIMA only, or a switch cohort (transitioning from originator to HADLIMA).

Of 58,407 total individuals identified, 16,322 veterans transitioned from the originator to HADLIMA. The switch cohort had a mean age of 60 years and was 87% male and 75% white.¹
Rheumatoid arthritis (RA) represented the most common diagnosis (21.9%; n= 3577), followed by psoriatic arthritis (PsA; 8.4%; n= 1374), and ankylosing spondylitis (AS; 7.6%; n=1239).¹
Within 12 months of follow-up, 1.3% of patients switched back from HADLIMA to the originator. Treatment adherence metrics remained similar pre- and post-switch.¹
Across all indications in the switch cohort, mean per-patient pharmacy costs decreased by $8,100 in the first year following the switch.¹
At the system level, the switch resulted in $132 million total estimated savings to the Veterans Affairs Healthcare System.¹

Poster presentation details

Title: Real-World Evidence From the US Veterans Affairs Healthcare System of a Successful Switch to Biosimilar adalimumab-bwwd (Hadlima) from Originator adalimumab (Humira) Following a Formulary Change
Presentation date & time: Monday, November 9, 2026, 10:30 AM to 12:30 PM ET
Presenter: Ricardo Infante, Medical Affairs Lead, Organon

About HADLIMA^® (adalimumab-bwwd) Injection

HADLIMA is a tumor necrosis factor (TNF) blocker indicated for:

Rheumatoid Arthritis: HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
Juvenile Idiopathic Arthritis: HADLIMA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
Psoriatic Arthritis: HADLIMA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
Ankylosing Spondylitis: HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Crohn’s Disease: HADLIMA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
Ulcerative Colitis: HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.

Limitations of Use:

The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers.

Plaque Psoriasis: HADLIMA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Hidradenitis Suppurativa: HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
Uveitis: HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult and pediatric patients 2 years of age and older.

SELECTED SAFETY INFORMATION

SERIOUS INFECTIONS

Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue HADLIMA if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients:

with chronic or recurrent infection
who have been exposed to TB
with a history of opportunistic infection
who resided in or traveled in regions where mycoses are endemic
with underlying conditions that may predispose them to infection

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Do not start HADLIMA during an active infection, including localized infections.
Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
If an infection develops, monitor carefully and initiate appropriate therapy.
Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HADLIMA with other biologic DMARDs (eg, anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

Consider the risks and benefits of HADLIMA treatment prior to initiating or continuing therapy in a patient with known malignancy.
In clinical trials, more cases of malignancies were observed among adalimumab-treated subjects compared to control subjects.
Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated subjects. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA.
In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop HADLIMA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including HADLIMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.

Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.

Exercise caution in patients who are carriers of HBV and monitor them during and after HADLIMA treatment.

Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA after HBV treatment.

NEUROLOGIC REACTIONS

TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.

Exercise caution when considering HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop.

HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products.

Consider stopping HADLIMA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully.

AUTOIMMUNITY

Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

Patients on HADLIMA should not receive live vaccines.

Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA therapy.

Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

Before prescribing HADLIMA, please read thePrescribing Information, including the Boxed Warning about serious infections and malignancies. TheMedication Guide andInstructions for Use also are available.

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at http://www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including statements regarding Organon’s presentation of data at the ACR Annual Meeting and the potential benefits of biosimilars. Forward-looking statements may be identified by words such as “will,” “can,” “potential,” “potentially,” “believe,” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

*The types of immunologic condition being treated are defined by multiple ICD-10-CM diagnosis codes from 12 months before to 30-days after the index date.

REFERENCES

_______________________________

¹ Goodall G, Liu H, Willis C, et al. Real-world evidence from the US Veterans Affairs Healthcare System of a successful switch to biosimilar adalimumab-bwwd (Hadlima) from originator adalimumab (Humira) following a formulary change. Poster presented at: American College of Rheumatology (ACR) Convergence; November 6–11, 2026; Orlando, FL.

² Fitzgerald T, Melsheimer R, Lafeuille MH, et al. Switching and discontinuation patterns among patients stable on originator infliximab who switched to an infliximab biosimilar or remained on originator infliximab. Biologics. 2021;15:1-15. doi:10.2147/BTT.S285610

³ Farrar KG, Masters NB, Do D, et al. Real-world switching and switch-back patterns among patients transitioning from adalimumab to biosimilars in the United States (February 2023 to August 2025). J Manag Care Spec Pharm. 2026;32(7):1-8. doi:10.18553/jmcp.2026.32.7.856

⁴ Organon Announces HADLIMA™ (adalimumab-bwwd) Has Been Exclusively Selected by the US Department of Veterans Affairs (VA), Replacing HUMIRA on Its National Formulary. Organon. February 20, 2024. Accessed October 20, 2026. https://www.organon.com/supplier-guides/news/organon-announces-hadlima-adalimumab-bwwd-has-been-exclusively-selected-by-the-us-department-of-veterans-affairs-va-replacing-humira-on-its-national-formulary/

US-ADA-111212 11/26

View source version on businesswire.com: https://www.businesswire.com/news/home/20261107078326/en/

Media Contacts:

Janine Colavita

(732) 861-3806

Karissa Peer

(614) 314-8094

Investor Contacts:

Jennifer Halchak

(201) 275-2711

Renee McKnight

(551) 204-6129

KEYWORDS: Florida New Jersey United States North America

INDUSTRY KEYWORDS: Science Biotechnology Defense Research Pharmaceutical Managed Care Health Veterans

MEDIA:

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November 7, 2026 8:03 am

Berkshire Hathaway Inc. News Release

Berkshire Hathaway Inc. News Release

OMAHA, Neb.–(BUSINESS WIRE)–
(BRK.A; BRK.B) –

Berkshire’s operating results for the third quarter and first nine months of 2026 and 2025 are summarized in the following paragraphs. However, we urge investors and reporters to read our 10-Q, which has been posted at www.berkshirehathaway.com. The limited information that follows in this press release is not adequate for making an informed investment judgment.

Earnings of Berkshire Hathaway Inc. and its consolidated subsidiaries for the third quarter and first nine months of 2026 and 2025 are summarized below. Earnings are stated on an after-tax basis. (Dollar amounts are in millions, except for per share amounts).

	Third Quarter				First Nine Months
	2026		2025		2026		2025
Net earnings attributable to Berkshire shareholders	$	22,112	$	30,796	$	57,885	$	47,769
Net earnings includes:
Investment gains (losses)		9,407		17,311		20,851		17,243
Other-than-temporary impairment of investment in Kraft Heinz		—		—		—		(3,760	)
Operating earnings		12,705		13,485		37,034		34,286
Net earnings attributable to Berkshire shareholders	$	22,112	$	30,796	$	57,885	$	47,769

Net earnings per average equivalent Class A Share	$	15,502	$	21,413	$	40,377	$	33,214
Net earnings per average equivalent Class B Share	$	10.33	$	14.28	$	26.92	$	22.14

Average equivalent Class A shares outstanding		1,426,372		1,438,223		1,433,603		1,438,223
Average equivalent Class B shares outstanding		2,139,557,257		2,157,335,139		2,150,404,500		2,157,335,139

Note: Per share amounts for Class B shares are 1/1,500^thof those shown for Class A shares.

In the table above, investment gains (losses) in each period predominantly relate to our investments in equity securities. Generally Accepted Accounting Principles (“GAAP”) require that we include the changes in unrealized gains (losses) of our equity security investments as a component of investment gains (losses) in our earnings statements. Investment gains (losses) in 2026 include gains of $7.7 billion in the third quarter and $11.6 billion in the first nine months and in 2025 include gains of $9.2 billion in the third quarter and $3.3 billion in the first nine months due to changes during the third quarter and the first nine months in the unrealized gains that existed in our equity security investment holdings. Investment gains (losses) in 2026 also include after-tax realized gains on sales of investments of $1.7 billion in the third quarter and $9.3 billion in the first nine months and in 2025 include $8.1 billion in the third quarter and $14.6 billion in the first nine months. Investment gains (losses) in the table above also include losses of $0.7 billion in the first nine months of 2025 from other investments.

The amount of investment gains (losses) in any given quarter is usually meaningless and delivers figures for net earnings per share that can be extremely misleading to investors who have little or no knowledge of accounting rules.

An analysis of Berkshire’s operating earnings follows (dollar amounts are in millions).

	Third Quarter				First Nine Months
	2026		2025		2026		2025
Insurance – underwriting	$	1,352	$	2,369	$	4,800	$	5,697
Insurance – investment income		2,734		3,181		8,472		9,441
BNSF		1,729		1,449		4,664		4,129
Berkshire Hathaway Energy Company		1,612		1,489		3,617		3,288
Manufacturing, service and retailing		4,042		3,616		11,711		10,277
Other*		1,236		1,381		3,770		1,454
Operating earnings	$	12,705	$	13,485	$	37,034	$	34,286

* Includes foreign currency exchange losses related to non-U.S. Dollar denominated debt in 2026 of $343 million in the third quarter and gains of $232 million in the first nine months and in 2025 includes foreign currency exchange gains of $331 million in the third quarter and losses of $1.3 billion in the first nine months.

Berkshire acquired approximately $9.6 billion in treasury shares during the third quarter of 2026, bringing the nine-month total to about $14.4 billion. On September 30, 2026, there were 1,418,900 Class A equivalent shares outstanding. At September 30, 2026, insurance float (the net liabilities we assume under insurance contracts) was approximately $178.5 billion, an increase of approximately $2.1 billion since yearend 2025.

Use of Non-GAAP Financial Measures

This press release includes certain non-GAAP financial measures. The reconciliations of such measures to the most comparable GAAP figures in accordance with Regulation G are included herein.

Berkshire presents its results in the way it believes will be most meaningful and useful, as well as most transparent, to the investing public and others who use Berkshire’s financial information. That presentation includes the use of certain non-GAAP financial measures. In addition to the GAAP presentations of net earnings, Berkshire shows operating earnings defined as net earnings exclusive of investment gains (losses), impairments of goodwill and intangible assets and other-than-temporary impairments of equity method investments.

Although the investment of insurance and reinsurance premiums to generate investment income and investment gains or losses is an integral part of Berkshire’s operations, the generation of investment gains or losses is independent of the insurance underwriting process. Moreover, as previously described, under applicable GAAP accounting requirements, we are required to include the changes in unrealized gains (losses) of our equity security investments as a component of investment gains (losses) in our periodic earnings statements. In sum, investment gains (losses) for any particular period are not indicative of quarterly business performance.

About Berkshire

Berkshire Hathaway and its subsidiaries engage in diverse business activities including insurance and reinsurance, utilities and energy, freight rail transportation, manufacturing, services and retailing. Common stock of the company is listed on the New York Stock Exchange, trading symbols BRK.A and BRK.B.

Cautionary Statement

Certain statements contained in this press release are “forward looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are not guaranties of future performance and actual results may differ materially from those forecasted.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261107409212/en/

Chuck Chang

402-346-1400

KEYWORDS: United States North America Nebraska

INDUSTRY KEYWORDS: Other Manufacturing Other Retail Manufacturing Personal Finance Other Construction & Property Food/Beverage Residential Building & Real Estate Fashion Construction & Property Retail Other Professional Services Insurance Other Energy Utilities Finance Rail Air Energy Transport Professional Services

MEDIA:

November 6, 2026 7:28 pm

LifeMD Reschedules Third Quarter 2026 Earnings Release and Conference Call to November 12, 2026

NEW YORK, Nov. 06, 2026 (GLOBE NEWSWIRE) — LifeMD, Inc. (Nasdaq: LFMD), a leading provider of virtual primary care and pharmacy services, today announced that the Company has rescheduled its third quarter 2026 earnings release and conference call to Thursday, November 12, 2026.

LifeMD expects to issue its third quarter 2026 earnings press release on or around 4:05 p.m. Eastern time on Thursday, November 12, 2026 followed by the conference call at 4:30 p.m. Eastern time. Information for the rescheduled conference call is as follows:

Conference Call & Webcast Details

Date:	Thursday, November 12^th
Time:	4:30 p.m. Eastern time
Toll-Free Dial-In:	(877) 270-2148
International Dial-In:	+1 (412) 902-6510
Conference ID:	LifeMD, Inc. Third Quarter 2026 Results
Live & Archived Webcast:	Link

About LifeMD, Inc.

LifeMD® is a leading virtual care company making high-quality healthcare more accessible, convenient, and affordable. Through its vertically integrated platform, LifeMD connects patients with a 50-state affiliated medical group, laboratory services, a state-of-the-art nationwide pharmacy with home delivery, and a U.S.-based patient care center. Together, these capabilities support care across more than 200 conditions, including primary care, men’s and women’s health, weight management, and hormone therapy. For more information, please visit LifeMD.com.

Investor Contact

[email protected]

Media Contact

[email protected]

November 6, 2026 7:26 pm

SPACCircle Acquisition Corp. Announces the Separate Trading of its Class A Ordinary Shares, Warrants and Rights, Commencing November 10, 2026

Sacramento, CA, Nov. 06, 2026 (GLOBE NEWSWIRE) — SPACCircle Acquisition Corp. (Nasdaq: SCQCU) (the “Company”) announced today that, commencing November 10, 2026, holders of the units sold in the Company’s initial public offering may elect to separately trade the Company’s Class A ordinary shares, warrants and rights included in the units. The Class A ordinary shares, warrants and rights that are separated will trade on the Nasdaq Global Market under the symbols “SCQC,” “SCQCW” and “SCQCR,” respectively. Those units not separated will continue to trade on the Nasdaq Global Market under the symbol “SCQCU.”

The units were initially offered by the Company in an underwritten offering. D. Boral Capital LLC acted as sole book-running manager of the offering. Copies of the prospectus relating to the offering may be obtained from D. Boral Capital LLC, 590 Madison Avenue, 39th Floor, New York, NY 10022, by email at [email protected], or by telephone at (212) 970-5150.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities of the Company, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About SPACCircle Acquisition Corp.

The Company was formed for the purpose of effecting a merger, amalgamation, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. It may pursue an initial business combination target in any business or industry.

Forward-Looking Statements

This press release may include, and oral statements made from time to time by representatives of the Company may include, “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements regarding possible business combinations and the financing thereof, and related matters, as well as all other statements other than statements of historical fact included in this press release are forward-looking statements. When used in this press release, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions, as they relate to us or our management team, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, the Company’s management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors detailed in the Company’s filings with the Securities and Exchange Commission (“SEC”). All subsequent written or oral forward-looking statements attributable to us or persons acting on our behalf are qualified in their entirety by this paragraph. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s registration statement and prospectus for the Company’s initial public offering filed with the SEC. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Company Contact

SPACCircle Acquisition Corp.
John Dicconson
Chief Executive Officer and Chairman
831-236-7207

November 6, 2026 6:11 pm

Biofrontera Inc. to Report Third Quarter 2026 Financial Results on November 13, 2026

WOBURN, Mass., Nov. 06, 2026 (GLOBE NEWSWIRE) — Biofrontera Inc. (NASDAQ: BFRI) (“Biofrontera” or the “Company”), a U.S.-based biopharmaceutical company engaging in the development, manufacturing, and commercialization of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy, today announced that it will report financial results for the third quarter ended September 30, 2026 before the market opens on Friday, November 13, 2026.

Management will host a conference call and webcast the same day at 10:00 a.m. Eastern Time to discuss the results and provide a business update.

Conference Call and Webcast Details

Detail	Information
Date	Friday, November 13, 2026
Time	10:00 a.m. Eastern Time
U.S. / Canada toll-free	1-877-877-1275
International	1-412-858-5202
Webcast	https://event.choruscall.com/mediaframe/webcast.html?webcastid=pyDsmcVf

Participants dialing in by telephone should ask to be joined into the Biofrontera call. The webcast will be accessible beginning approximately 20 minutes prior to the start of the call.

About Biofrontera Inc.

Biofrontera Inc. (NASDAQ: BFRI) is a U.S.-based biopharmaceutical company engaging in the development, manufacturing, and commercialization of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy. The Company’s products, which include Ameluz^®as well as the RhodoLED^® Lamps are used for the treatment of actinic keratosis, a common skin condition characterized by the growth of pre-cancerous skin lesions and, following U.S. Food and Drug Administration approval in September 2026, superficial basal cell carcinoma. For more information, visit www.biofrontera-us.com.

Investor Contact

Ben Shamsian
Lytham Partners
[email protected]

November 6, 2026 6:03 pm

AngioDynamics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

AngioDynamics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

LATHAM, N.Y.–(BUSINESS WIRE)–
AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced the grant of inducement awards to Eric Honroth in connection with his appointment as Chief Executive Officer of the Company effective as of November 2, 2026.

On November 2, 2026 (the “Grant Date”), as an inducement material to Mr. Honroth entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and pursuant to approval by the independent Compensation Committee of the Board of Directors of the Company (the “Committee”), the Company granted to Mr. Honroth (i) time-based restricted stock units with respect to 62,928 shares of Common Stock of the Company (the “First Sign-On Award”), (ii) performance-based restricted stock units with respect to 62,928 shares of Common Stock of the Company at the target level of performance (the “Second Sign-On Award”) and (iii) time-based restricted stock units with respect to 38,265 shares of Common Stock of the Company (the “Third Sign-On Award”).

The First Sign-On Award will vest in equal annual installments over four years, subject to Mr. Honroth’s continued service through each applicable vesting date.

The Second Sign-On Award will vest, if at all, based on a combination of the Company’s revenue, adjusted EBITDA, and relative total shareholder return over a three-year performance period, subject to Mr. Honroth’s continued service through the date of the Committee’s certification as to whether or not the threshold performance metrics have been met. The number of shares that may be earned under the PSUs ranges from 0% of target to 240% of target.

The Third Sign-On Award will vest in two equal installments on November 2, 2027 and November 2, 2028, subject to Mr. Honroth’s continued service through each applicable vesting date.

About AngioDynamics, Inc.

AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life.

The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit www.angiodynamics.com.

Safe Harbor

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics’ expectations, expressed or implied. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics’ technology or assertions that AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign healthcare reforms and government regulations, results of pending or future clinical trials, overall economic conditions (including inflation, tariffs, labor shortages and supply chain challenges including the cost and availability of raw materials), the results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to obtain regulatory clearances or approval of its products, or to integrate acquired businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2026. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

AngioDynamics and the AngioDynamics logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261106038551/en/

Investor Contact:

Stephen Trowbridge

Executive Vice President & CFO

518-795-1408

[email protected]

Media Contact:

Saleem Cheeks

Vice President, Communications

518-795-1174

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Oncology Medical Devices Health Health Technology Cardiology Biotechnology

MEDIA:

November 6, 2026 5:43 pm

bioAffinity Technologies Reports Third Quarter 2026 Results and Continued Momentum in CyPath® Lung Commercialization

bioAffinity Technologies Reports Third Quarter 2026 Results and Continued Momentum in CyPath® Lung Commercialization

CyPath® Lung test unit sales double year to date over 2025, with solid gains in physician utilization and recurring orders; testing revenue increases 79% year-to-date

Company advances precision medicine pipeline with new asthma and COPD research, collaboration with Pictor and continued development of topical skin cancer therapeutics

SAN ANTONIO–(BUSINESS WIRE)–bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease and topically delivered therapeutics for skin cancer, today reported financial results and business highlights for the third quarter (Q3) ended September 30, 2026.

Q3 2026 Highlights and Recent Events

CyPath® Lung test unit sales increased 100% through Q3 compared to the first nine months of 2025.
CyPath Lung testing revenue for the first nine months of 2026 increased 79% to approximately $1.1 million, compared to the same period in 2025.
In July 2026, the Company surpassed the total number of CyPath Lung test reports delivered to physicians during 2025.
The number of ordering physicians increased by 89% in the third quarter of 2026 compared to the third quarter of 2025, continuing to expand clinical utilization of CyPath Lung. Physicians already ordering CyPath Lung tests increased their volume by 48% year over year.
The Company expanded its government healthcare distribution network and commercial reach through an agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business and established distributor of medical-surgical and laboratory products and services to government agencies, including the Department of Veterans Affairs (VA).
The ongoing longitudinal clinical trial designed to evaluate the clinical performance of CyPath Lung continued to advance. As of September 30, 2026, 11 clinical sites were active, including nine VA and military medical centers that had begun patient enrollment. The John P. Murtha Cancer Center Research Program at the Uniformed Services University of the Health Sciences is providing support and funding for the trial.
In July, the Company published a comprehensive clinical review and white paper authored by Chief Medical Officer Gordon H. Downie, MD, PhD, presenting a practical framework for incorporating CyPath Lung into pulmonology and oncology practices. Dr. Downie presented the framework to physicians in October at the annual meeting of the American College of Chest Physicians (CHEST 2026).
The Company advanced CyPath Lung for potential use in surveillance of lung cancer survivors as a complement to imaging to monitor patients for cancer recurrence and new primary lung cancers.
The Company presented positive research results at CHEST 2026 relating to its development of noninvasive tests to characterize lung inflammation and investigate biologic drug targets for asthma and COPD therapies. Further development and validation are underway to determine whether this approach can identify patients who may benefit from specific biologic therapies or support monitoring of lung inflammation over time.
The Company announced a collaboration with Pictor®, Inc., a targeted proteomic platform company, to support development and potential commercialization of bioAffinity Technologies’ next-generation diagnostic tests designed to provide a more complete picture of lung inflammation in patients with asthma and COPD.
The Company continued research into potential topically delivered therapeutics for squamous and basal cell skin cancers. Preliminary research findings have demonstrated that self-delivering, stabilized small interfering RNAs (siRNAs) selectively kill squamous and basal carcinoma cells in vitro while sparing noncancerous cutaneous cells.
In September, bioAffinity announced the grant of a Hong Kong patent covering CyPath Lung’s proprietary flow cytometry + AI platform for predicting the likelihood of lung cancer by characterizing cell populations in sputum. In October, the Company received a Notice of Allowance from the Japan Patent Office indicating its intention to grant a patent for the method of predicting the likelihood of lung cancer used by the CyPath Lung test.
The Company raised an aggregate of $8.0 million in gross proceeds through a private placement offering in August 2026 and a registered direct offering and concurrent private placement in October 2026 for working capital and general corporate purposes, including support for the ongoing commercialization of CyPath Lung.

Management Commentary

“Our third-quarter results reflect CyPath Lung’s continued momentum in addressing the critical need for early lung cancer detection, driven by both new physicians ordering the test and increased use by existing customers. We believe this growth reflects increasing physician engagement and recognition of the role CyPath Lung can play in managing care for patients at risk for lung cancer. We are also advancing its potential use in surveillance following curative-intent treatment, where CyPath Lung could complement imaging in monitoring for recurrence and new cancers,” said Maria Zannes, President of CEO of bioAffinity Technologies. “Peer-to-peer education and growing clinical experience with the test remain important drivers of adoption, while our longitudinal study is designed to generate robust, real-world data across multiple sites to further evaluate how CyPath Lung may support risk assessment and clinical decision-making. Together, these efforts advance our objective of establishing CyPath Lung as a standard of care for evaluating patients at risk for lung cancer.

“We continue to build the foundation for long-term growth. Beyond lung cancer, we are advancing our platform to take advantage of precision medicine opportunities in asthma and COPD, where sputum-based analysis may help characterize lung inflammation and help physicians better match individual patients to available treatments, including Tezspire, Dupixent and Nucala. The tests we are developing are designed to meet a critical need for precision diagnostics in the multi-billion-dollar asthma and COPD therapeutic markets.

“Our patent portfolio now includes 22 awarded U.S. and foreign patents and 36 pending applications. The recent Hong Kong patent and the Japanese patent allowance, once awarded, are important additions to our patent portfolio. Our distribution agreement with AvMEDICAL is intended to expand our reach into government healthcare markets, including the VA, where the substantial burden of lung cancer underscores the need for more effective ways to evaluate pulmonary nodules and improve patient outcomes.

Ms. Zannes concluded, “Our priorities remain disciplined execution, expanding commercial adoption and advancing our clinical and research programs. We are also pursuing topical therapeutic approaches for squamous and basal cell skin cancers based on promising findings involving the CD320 and LRP2 receptors. We believe our expertise in flow cytometry, automated data analysis and siRNA technology provides a foundation for developing differentiated products across these markets. Together, these programs demonstrate our commitment to translating scientific innovation into meaningful new opportunities for patients and the Company.”

Third Quarter 2026 Financial Results

Total revenue for the quarter ended September 30, 2026, was approximately $1.1 million, compared with approximately $1.4 million for the same period in 2025. The decrease is due primarily to a decrease in average reimbursement per CyPath Lung test and a slight decline in total cases completed at Precision Pathology Laboratory Services (PPLS) compared to the same period in 2025, in part due to internal business changes at three PPLS research clients. Multiple accounts previously serviced under these clients have since returned to PPLS. The Company is working to restore additional accounts and improve reimbursement levels.

Net loss for the quarter ended September 30, 2026, was approximately $5.3 million, compared with approximately $5.1 million for the third quarter of 2025. The increase in net loss is primarily due to the increase in loss from operations of approximately $3.5 million from approximately $2.3 million in the prior-year quarter, partially offset by a $1.2 million loss from the change in fair value of warrants, compared with a $2.7 million loss in the prior-year quarter.

Cash and cash equivalents were approximately $2.6 million as of September 30, 2026, compared with approximately $6.4 million at December 31, 2025. Subsequent to quarter-end, the Company completed a financing that generated approximately $4.0 million in gross proceeds.

Operating expenses for the third quarter of 2026 were approximately $4.6 million, compared with approximately $3.7 million in the third quarter of 2025.

Direct costs and expenses were approximately $1.1 million, compared with $942,000 in the prior-year period. The increase primarily reflected additional personnel to process CyPath Lung commercial tests and tests associated with the longitudinal clinical study.
Research and development expenses increased 18% year over year to approximately $389,000, primarily due to laboratory supplies and costs associated with relocating laboratory facilities in June 2026.
Clinical development expenses increased 75% to approximately $251,000, compared with approximately $143,000 in the third quarter of 2025. The increase primarily reflected the initiation of clinical trial sites and patient enrollment in the longitudinal clinical study.
Selling, general and administrative expenses increased 28% to approximately $2.8 million, compared with approximately $2.2 million in the prior-year period. The increase primarily reflected additional sales and marketing personnel and support services to expand commercialization of CyPath Lung.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung analyzes the lung microenvironment by using advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. The test incorporates a novel fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. For more information, visit www.cypathlung.com.

About bioAffinity Technologies, Inc.

bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” and similar expressions may identify forward-looking statements, although not all forward-looking statements contain these words. Actual results could differ materially from those expressed or implied because of risks and uncertainties, including the Company’s ability to expand the commercial adoption of CyPath Lung and capitalize on government healthcare market opportunities; the timing, cost, enrollment and outcome of clinical studies; the possibility that preliminary, in vitro or study-specific findings will not be replicated or translate into safe and effective therapies or commercial products for asthma, COPD or skin cancer; the need for further validation of new applications, including surveillance; the extent and timing of physician adoption, repeat utilization and customer retention; payer coverage, reimbursement rates and collections; and the Company’s ability to obtain, maintain and enforce intellectual property rights. Additional risks are discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent SEC filings, including its reports on Forms 10-Q and 8-K. Forward-looking statements reflect expectations and assumptions only as of the date of this release. Readers should not place undue reliance on them. The Company undertakes no obligation to update these statements, except as required by applicable law.

bioAffinity Technologies, Inc.
Condensed Consolidated Balance Sheets

	September 30, 2026			December 31, 2025
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	2,550,034		$	6,449,782
Accounts and other receivables, net		742,144			541,962
Inventory		108,754			53,548
Prepaid expenses and other current assets		427,230			519,916
Total current assets		3,828,162			7,565,208

Non-current assets:
Property and equipment, net		362,359			265,593
Operating lease right-of-use asset, net		730,572			334,289
Finance lease right-of-use asset, net		538,326			661,575
Goodwill		1,404,486			1,404,486
Intangible assets, net		673,056			716,806
Other assets		16,710			12,815

Total assets	$	7,553,671		$	10,960,772

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:
Accounts payable	$	949,018		$	761,901
Accrued expenses		1,143,227			1,717,989
Unearned revenue		48,874			42,405
Operating lease liability, current portion		168,534			139,220
Finance lease liability, current portion		78,926			139,490
Notes payable, current portion		144,715			105,161
Total current liabilities		2,533,294			2,906,166

Non-current liabilities:
Operating lease liability, net of current portion		596,086			202,878
Finance lease liability, net of current portion		475,772			532,759
Notes payable, net of current portion		33,958			41,313

Total liabilities		3,639,110			3,683,116

Stockholders’ equity:
Preferred Stock, par value $0.001 per share; 20,000,000 shares authorized; 150 shares and 700 shares issued and outstanding at September 30, 2026, and December 31, 2025, respectively		1			1
Common Stock, par value $0.007 per share; 350,000,000 shares authorized; 1,166,625 and 299,826 issued and outstanding at September 30, 2026, and December 31, 2025, respectively		8,166			2,097
Additional paid-in capital		84,734,173			75,829,622
Accumulated deficit		(80,827,779	)		(68,554,064	)

Total stockholders’ equity		3,914,561			7,277,656

Total liabilities and stockholders’ equity	$	7,553,671		$	10,960,772

bioAffinity Technologies, Inc.
Unaudited Condensed Consolidated Statements of Operations

	Three Months Ended September 30,						Nine Months Ended September 30,
	2026			2025			2026			2025

Net revenue	$	1,070,280		$	1,446,066		$	3,932,386		$	4,569,146

Operating expenses:
Direct costs and expenses		1,114,176			942,211			3,130,649			3,326,673
Research and development		389,122			330,589			1,100,404			1,009,347
Clinical development		251,043			143,311			1,060,968			410,943
Selling, general and administrative		2,759,769			2,209,441			8,859,961			6,876,551
Depreciation and amortization		66,842			113,360			242,916			381,177

Total operating expenses		4,580,952			3,738,912			14,394,898			12,004,691

Loss from operations		(3,510,672	)		(2,292,846	)		(10,462,512	)		(7,435,545	)

Other income (expense):
Interest income		4,734			1,088			18,118			3,655
Interest expense		(10,713	)		(5,358	)		(37,123	)		(31,303	)
Other income		3,144			513			6,516			38,568
Other expense		(13,072	)		(3,839	)		(48,270	)		(16,828	)
Offering costs allocated to warrant liability		(532,209	)		—			(532,209	)		(479,696
Loss on warrant liabilities		(1,218,235	)		(2,747,460	)		(1,218,235	)		(3,810,278	)

Total other income (expense), net		(1,766,351	)		(2,755,056	)		(1,811,203	)		(4,295,882	)

Net loss before provision for income tax expense		(5,277,023	)		(5,047,902	)		(12,273,715	)		(11,731,427	)

Income tax expense		—			3,182			—			40,861

Net loss	$	(5,277,023	)	$	(5,051,084	)	$	(12,273,715	)	$	(11,772,288	)

Net loss per common share, basic and diluted	$	(5.89	)	$	(71.05	)	$	(23.72	)	$	(219.47	)

Weighted average common shares outstanding		896,271			71,090			517,490			53,640

View source version on businesswire.com: https://www.businesswire.com/news/home/20261106489581/en/

bioAffinity Technologies

Julie Anne Overton

Director of Communications

[email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Research General Health Radiology Pharmaceutical Oncology Infectious Diseases Genetics Surgery Clinical Trials Science Biotechnology FDA Health

MEDIA:

Logo

November 6, 2026 5:33 pm

Univest Securities, LLC Announces Closing of $1.2 Million Registered Direct Offering for its Client NetClass Technology Inc (NASDAQ: NTCL)

New York, Nov. 06, 2026 (GLOBE NEWSWIRE) — Univest Securities, LLC (“Univest”), a member of FINRA and SIPC, and a full-service investment bank and securities broker-dealer firm based in New York, today announced the closing of a registered direct offering (the “Offering”) of $1.2 million for its client NetClass Technology Inc (NASDAQ: NTCL) (the “Company”), a B2B smart education IT solutions provider with offices in Shanghai, Hong Kong, Singapore and Tokyo.

Under the terms of the securities purchase agreement, the Company has agreed to sell to a single institutional investor 3,000,000 Class A Ordinary Shares of the Company (or pre-funded warrants in lieu thereof), at a purchase price of $0.40 per share in the Offering.

The aggregate gross proceeds to the Company were $1.2 million, before deducting placement agent fees and other offering expenses payable by the Company.

Univest Securities, LLC acted as the sole placement agent.

The registered direct offering was made pursuant to a shelf registration statement on Form F-3 (File No. 333-292458) previously filed by the Company and declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on February 12, 2026. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained by contacting Univest Securities, LLC at [email protected], or by calling +1 (212) 343-8888.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of such securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. Copies of the prospectus supplement relating to the registered direct offering, together with the accompanying base prospectus, upon filing, can be obtained at the SEC’s website at www.sec.gov.

About Univest Securities, LLC

Registered with FINRA since 1994, Univest Securities, LLC provides a wide variety of financial services to its institutional and retail clients globally, including brokerage and execution services, sales and trading, market making, investment banking and advisory, and wealth management. It strives to provide clients with value-added service and focuses on building long-term relationships with its clients. As a prominent name on Wall Street, Univest has successfully raised over $1.8 billion in capital for issuers across the globe since 2019 and has completed approximately 100 transactions spanning a wide array of investment banking services in various industries, including technology, life sciences, industrial, consumer goods, etc. For more information, please visit: www.univest.us.

About NetClass Technology Inc

NETCLASS TECHNOLOGY INC is a leading B2B smart education specialist with offices in Shanghai, Hong Kong, Singapore, and Tokyo, providing innovative IT solutions to schools, training institutions, corporations, public agencies, and other organizations. The Company’s services include SaaS subscription services and application software development, with solutions spanning teaching and campus management, online teaching, examinations, epidemic prevention, data storage, EDC (Education Credit) blockchain systems, and lecturer evaluation services. The Company’s mission is to deliver reliable, high-quality products that drive sustainable growth for its customers. For more information, please visit the Company’s website: https://ir.netclasstech.com/.

Forward-Looking Statements

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may, “will, “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks, including, but not limited to, the uncertainties related to market conditions and the completion of the initial public offering on the anticipated terms or at all, and other factors discussed in the “Risk Factors” section of the registration statement filed with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company’s filings with the SEC, which are available for review at

www.sec.gov

. Univest Securities, LLC and the Company undertake no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

For more information, please contact:

Univest Securities, LLC

Edric Guo

Chief Executive Officer

75 Rockefeller Plaza, Suite 25A
New York, NY 10019
Phone: (212) 343-8888
Email: [email protected]