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QIAGEN reports full Q3 2026 results

On November 4, 2026 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported full results for the third quarter of 2026, with net sales and adjusted diluted earnings per share (EPS) ahead of the outlook.

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In line with preliminary results, Q3 2026 sales rose 3% to $548 million compared with Q3 2025, also increasing 3% at constant exchange rates (CER) and exceeding the outlook for about 1-2% CER growth. Consumables and related revenues rose 3% CER and were 91% of sales, while instrument sales rose 1% CER. Sales from the pillars rose 7% CER to $415 million, partly offset by a 7% CER decline in the rest of the portfolio.

Operating income increased to $132 million from $129 million in Q3 2025. Adjusted operating income, which excludes various charges and other items in both periods, rose 6% to $167 million over Q3 2025. The adjusted operating income margin was 30.4% of sales, an increase of 0.8 percentage points from 29.6% in Q3 2025, as sales growth, a growing contribution from higher-margin consumables and efficiency gains supported investments in Parse Biosciences after the late 2025 acquisition.

Diluted EPS was $0.51 in Q3 2026 compared with $0.60 in Q3 2025. Adjusted diluted EPS increased to $0.65 from $0.61, while results at CER of $0.65 were above the outlook for at least $0.62 CER.

Please find a PDF of the full press release at the top of this page.

Use of adjusted results

QIAGEN reports adjusted results and constant exchange rate (CER) measures, along with other non-GAAP financial metrics, to show underlying business performance. These include adjusted gross profit and margin, adjusted EBITDA, adjusted operating income and expenses, adjusted operating income margin, adjusted pre-tax and net income, adjusted tax rate and adjusted diluted EPS, net leverage and free cash flow. Adjusted results are non-GAAP measures that exclude items outside of ongoing core operations or that vary significantly between periods. CER results apply prior-year exchange rates. Free cash flow is defined as operating cash flow less purchases of property, plant and equipment. QIAGEN also uses these measures for planning, forecasting and compensation. They complement, but do not replace, GAAP results, are reconciled in the accompanying tables and may not be comparable to other companies’ measures.

(Press release, Qiagen, NOV 4, 2026, View Source [SID1234674177])

OPKO Health Reports Third Quarter 2026 Business Highlights and Financial Results

On November 4, 2026 OPKO Health, Inc. (NASDAQ: OPK), a multinational biopharmaceutical company, reported business highlights and financial results for the third quarter ended September 30, 2026.

Third Quarter 2026 and Recent Business Highlights
•
OPKO enters into agreement with Labcorp for the sale of substantially all remaining BioReference diagnostic operations. The agreement provides for $722 million in cash consideration at closing, subject to adjustments based on business revenues at closing, and up to $150 million in additional cash consideration over up to ten years based on Labcorp sales of the 4Kscore test. The transaction remains subject to regulatory approvals and customary closing conditions.

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OPKO expands strategic relationship with HealthCare Royalty through $125 million financing. OPKO issued an additional $125 million aggregate principal amount of senior secured royalty notes. The amended financing framework includes specified royalty payments receivable under OPKO’s license agreement with Eli Lilly and Company ("Lilly") related to mazdutide.

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OPKO Biologics Doses First Participant in Phase 1/2a Trial of OPK-8801001 for Acromegaly. The first participant has been dosed in a first-in-human Phase 1/2a clinical trial of OPK-8801001, an investigational, long acting human growth hormone receptor antagonist being developed for the treatment of acromegaly. The study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of OPK-8801001. OPK-8801001 is being developed using OPKO Biologics’ stabilizer based technology to extend biological half life and reduce injection frequency, with the goal of once weekly administration. In preclinical studies, OPK-8801001 produced robust, dose dependent sustained suppression of insulin-like growth factor-1 (IGF-1), a key marker of disease activity in acromegaly.

•
ModeX completes enrollment in MDX2301 Phase 1 clinical trial. MDX2301 is a tetravalent bispecific antibody designed to neutralize known SARS-CoV-2 variants while maintaining breadth and reducing the potential for resistance. The Phase 1 trial is evaluating safety, tolerability, and pharmacokinetics across multiple routes of administration in healthy volunteers and immunocompromised adults at high risk for severe COVID-19. This trial is being funded by the Biomedical Advanced Research and Development Authority (BARDA). Early data is expected to be presented in late 2026 or early 2027.

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ModeX continues enrollment in MDX2001 and MDX2004 Phase 1 trials. MDX2001, a tetraspecific T cell engager directed to solid tumors that express Trop2 and c-Met, continues to enroll participants in its Phase 1 study as planned. MDX2004, a trispecific immune rejuvenator that stimulates through CD3, CD28 and 4-1BBL, also continues Phase 1 enrollment as planned at sites in Australia and Israel. We expect to report initial safety, tolerability, pharmacokinetic and immune data for both studies in the first half of 2027.

•
ModeX continues enrolling patients in MDX2003 Phase 1 clinical trial in relapsed or refractory B-cell lymphoma. MDX2003 (CD19 x CD20 x CD3 x CD28) is a novel tetraspecific T-cell engager-expander designed to optimize sustained T-cell function and address the two most common and validated targets in lymphomas and leukemias. The MDX2003 Phase 1 study is evaluating safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in adults with B-cell lymphomas through dose-escalation and dose-expansion cohorts. B-cell lymphoma, a form of non-Hodgkin lymphoma, represents the most common lymphoma subtype, accounting for approximately 85% of cases.

•
OPKO continues U.S. enrollment in the Phase 1/2a study of OPK-88006, a dual GLP-1/glucagon receptor agonist. The study is evaluating the safety and pharmacokinetics of single ascending doses in healthy volunteers and changes in pharmacodynamic parameters with dose escalation to a desired maintenance dose over 20 weeks treatment in participants with presumed metabolic dysfunction-associated steatohepatitis. Single ascending dosing portion of the trials show favorable safety and tolerability 3 dose levels in 24 participants. The multiple ascending dose portion of the trial is actively enrolling subjects at 4 qualified study sites.

Third Quarter Financial Results

New presentation of continuing and discontinued operations. Following the Board of Directors’ September 30, 2026 approval of a plan to sell substantially all remaining BioReference diagnostic operations to Labcorp, OPKO classified the related disposal group as held for sale. Because the planned disposition represents a strategic shift that will eliminate substantially all remaining diagnostic operations, BioReference’s historical results are presented as discontinued operations for all periods shown, and prior period amounts have been recast. OPKO’s continuing operations are now reported through two segments, Global Products and Innovative Biotech, with unallocated corporate costs presented separately. This presentation is intended to provide a clearer view of the biopharmaceutical businesses that will remain with OPKO following the planned transaction.

•
Consolidated continuing operations. Revenue in the third quarter of 2026 increased 16% to $65.4 million from $56.4 million in the prior-year quarter, principally resulting from higher royalty revenue from Lilly, increased sales of Rayaldee and growth in international operations. Operating loss during the third quarter of 2026 decreased to $31.4 million from $33.6 million in the comparable 2025 period. Non-cash depreciation, amortization and equity-based compensation expense included in operating income (loss) was $20.7 million in the third quarter of 2026 compared with $20.5 million for the 2025 quarter. Net loss from continuing operations during the third quarter of 2026 was $35.5 million, or $0.05 per share, compared to $33.0 million, or $0.04 per share, in the third quarter of 2025.

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Global Products. Segment revenue for the third quarter of 2026 increased to $48.4 million from $39.4 million for the 2025 period. Revenue from products for the third quarter of 2026 was $41.8 million compared with $37.7 million for the comparable 2025 period. Rayaldee revenue in the third quarter of 2026 increased to $8.6 million from $7.5 million in the 2025 period, due to favorable gross-to-net adjustments as a result of changes to our Medicare Coverage. Revenue from international operations increased approximately $3.0 million, reflecting stronger performance in certain international markets, including our animal health business, and higher EirGen revenue driven by increased sales volumes and favorable product mix; this also included an approximately $0.7 million favorable foreign currency impact, primarily from appreciation of the Chilean peso and Mexican peso against the U.S. dollar. Licensing, collaboration and other revenue for the third quarter of 2026 increased to $6.6 million from $1.8 million for the 2025 quarter, primarily driven by $5.8 million of royalty revenue from Lilly, partially offset by lower contract manufacturers’ commercial milestone revenue recognized by EirGen. Total costs and expenses for the third quarter of 2026 were $42.4 million compared with $40.6 million for the 2025 quarter. Segment operating income for the third quarter of 2026 was $6.0 million compared with an operating loss of $1.2 million for the third quarter of 2025. Non-cash depreciation, amortization and equity-based compensation expense included in operating income (loss) was $6.3 million compared with $5.5 million.

•
Innovative Biotech. Licensing, collaboration and other revenue was $17.0 million in both the third quarter of 2026 and 2025. Lower BARDA revenue in the third quarter of 2026 of $7.5 million compared with $8.2 million during the 2025 quarter was substantially offset by $0.8 million of collaboration revenue under the Regeneron agreement, while Pfizer royalty revenue was relatively consistent. Research and development expense for the third quarter of 2026 increased to $30.4 million from $26.3 million during the 2025 quarter, primarily reflecting increased investment in ModeX development programs. Total costs and expenses during the third quarter of 2026 were $43.8 million compared with $39.5 million during the third quarter of 2025. Segment operating loss during the third quarter of 2026 was $26.8 million compared with $22.5 million during the 2025 quarter. Non-cash depreciation, amortization and equity-based compensation expense included in operating income (loss) was $13.4 million compared with $14.0 million during 2025.

•
Corporate. Unallocated corporate operating loss during the third quarter of 2026 was $10.6 million compared with $9.9 million during 2025, primarily reflecting employee-related and general administrative expenses not allocated to the operating segments. Non-cash depreciation, amortization and equity-based compensation expense included in operating income (loss) was approximately $1.0 million in each of the third quarters of 2026 and 2025.
•
Discontinued operations. BioReference generated revenue during the third quarter of 2026 of $71.8 million compared with $95.2 million during the third quarter of 2025. Loss from discontinued operations, net of tax, during the third quarter of 2026 was $18.0 million compared with income of $54.6 million in the prior-year quarter. The 2025 result included a $101.6 million gain on the sale of BioReference’s oncology diagnostics business and related clinical testing services assets to Labcorp.

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Liquidity and capital allocation. Cash, cash equivalents and restricted cash were $403.2 million as of September 30, 2026. During the quarter, OPKO received approximately $123.1 million of net proceeds from the additional royalty financing and approximately $19.8 million from the release of escrow funds related to the September 2025 oncology transaction. OPKO repurchased 7,050,000 shares during the quarter for approximately $10.6 million. As of September 30, 2026, approximately $115.7 million had been deployed under the $200 million share repurchase authorization, leaving approximately $84.3 million available.

Financial Guidance

In light of the pending transaction with Labcorp, OPKO has withdrawn its previously issued guidance for services revenue and total costs and expenses due to uncertainty regarding the timing of the potential closing and its impact on OPKO’s financial results. OPKO will continue to provide guidance for its continuing operations.

(Press release, Opko Health, NOV 4, 2026, View Source [SID1234674176])

Translational Data from Anal Cancer Patients Show Pelareorep Drives HPV-Specific Immune Responses, Supporting its Potential Across HPV-Driven Cancers

On November 4, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported new translational data from an ongoing study showing pelareorep’s ability to increase human papillomavirus ("HPV")-16-specific T cell clones and tumor-infiltrating lymphocyte ("TIL") clones in second-line or later squamous cell anal cancer ("SCAC") patients at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") 2026 Annual Meeting.

Pelareorep combined with a checkpoint inhibitor generated promising efficacy signals in second-line or later SCAC, including more than doubling the objective response rate and increasing median duration of response by 50% compared to the current approved therapy in that patient population. Multiple analyses help explain how pelareorep generates innate and adaptive immune responses and synergizes with other therapies. Highlights from the SITC (Free SITC Whitepaper) abstract include:
•In seven of eight evaluable patients, greater than two-fold increases in levels of the immune-activation biomarkers CXCL10, IFN-γ, and soluble PD-L1 were observed after one cycle of therapy.
•After three cycles of treatment, all four evaluable patients saw expansion of TIL clones in peripheral blood, which was associated with reductions in tumor size, including two complete responses and two partial responses.
•The four responding patients with TIL expansion also demonstrated significant expansion of at least one HPV-16-specific T cell clone.
•Among 14 patients evaluated for HPV-16-specific immune responses, six showed HPV-16 clonal expansion, and four of those patients experienced tumor shrinkage.
•The Phase 1/2, Simon 2-stage study is assessing the safety and efficacy of pelareorep in combination with a checkpoint inhibitor in second-line or later unresectable SCAC patients.

"These data reinforce pelareorep’s potential in multiple HPV-driven cancers as those tumor types generally exhibit low response rates to checkpoint inhibitors," said Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics. "Pelareorep’s ability to increase tumor-infiltrating lymphocyte populations and expand HPV-specific T cells form the basis for its synergy with checkpoint inhibitors and reinforces the potential of this combination to combat tumor growth in HPV-associated cancers. More broadly, these data support our belief in pelareorep as a backbone immunotherapy capable of activating anti-tumor immunity and improving responses to multiple therapies across a wide range of tumor types."

"We see HPV-associated cancers as a compelling business development opportunity for pelareorep, spanning anal, HPV-positive oropharyngeal, cervical, and other malignancies and representing a potential $3 to 5 billion market based on our internal estimates," said Jared Kelly, Chief Executive Officer of Oncolytics. "The combination of HPV-specific T cell expansion in our anal cancer study and prior clinical efficacy signals in head and neck cancer gives prospective partners a differentiated scientific and clinical rationale to explore pelareorep alongside checkpoint inhibitors. With systemic delivery, substantial clinical experience, and the potential to pursue multiple indications, we believe pelareorep offers a scalable opportunity to extend immunotherapy franchises into underserved patient populations. Our priority is to translate this evidence into strategic collaborations that can accelerate development and realize the broader commercial opportunity."

About Pelareorep
Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action that selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. It has been administered to over 1,200 patients, and clinical studies have demonstrated pelareorep’s potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types.

(Press release, Oncolytics Biotech, NOV 4, 2026, View Source [SID1234674175])

Nuvectis Pharma Reports Third Quarter 2026 Financial Results and Business Highlights

On November 4, 2026 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, reported its financial results for the third quarter of 2026 and provided an update on recent business progress.

"The last few months have been truly transformational for Nuvectis," said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. "The strategic in-licensing of ciprocopan (NXP100, our CFBi) and NXP200 (our paradox-breaker BRAF inhibitor) firmly establishes Nuvectis as a late-stage clinical development company with potential best-in-class assets. Our immediate priority is to advance ciprocopan toward a U.S. marketing application in PNH, as well as in additional indications. Our discussions with the FDA regarding the next steps for PNH are well underway, and we expect to provide an update before year-end. We plan to submit a U.S. IND for NXP100 by year-end. In parallel, we are building out our internal complement expertise to support a broad development program. Recently, we strengthened our team with the hiring of Dustin Little, M.D., a SVP Clinical Development and head of our Complement program. Dr. Little is a physician-scientist and board-certified nephrologist and brings the ideal combination of relevant industry experience, having worked in clinical development at AstraZeneca for a decade, and as a physician. We are excited to have him join the team."

Mr. Bentsur continued, "With its potential for a clear dosing convenience compared to injectable treatments and Fabhalta—the twice-daily oral CFBi—and supported by robust clinical data in PNH and IgAN as well as validating clinical data from the Fabhalta clinical trials, we believe ciprocopan has the potential to redefine the standard of care for patients in targeted settings."

"For NXP200, updated Phase 1b results in BRAF V600-mutated recurrent or progressive glioma were presented at the recent ESMO (Free ESMO Whitepaper) annual meeting. Single-agent NXP200 demonstrated durable responses, including complete responses, with activity also seen in patients previously treated with a BRAF inhibitor. The data are encouraging and underscore the potential of NXP200 to become a differentiated, best-in-class, second-generation, paradox-breaker BRAF inhibitor. We expect to submit a U.S. IND for NXP200 by year-end, and we look forward to providing additional NXP200 Phase 1b data from China, alongside a Phase 1b data update for NXP900, our SRC-Yes1 kinase inhibitor,in the coming months."

"We ended the quarter with approximately $140 million in cash, representing the strongest financial position in Nuvectis’ history," Mr. Bentsur concluded. "We expect this funding to support our operations into the second half of 2029, providing a runway that extends well beyond multiple potential value-creating clinical and regulatory milestones."

Recent Developments

· Completed in licensing of two potentially best-in-class drug candidates from Haisco Pharmaceutical Group and follow-on public offering anchored by leading healthcare investors.

Ciprocopan (NXP100)

· In July 2026, ciprocopan achieved its first global approval (in China), for the treatment of patients with PNH previously untreated with complement inhibitors. A second marketing application for ciprocopan in China is currently under review, for the treatment of PNH patients previously treated with anti C5 therapy, with approval expected in 1Q27; additional ongoing clinical trials for ciprocopan in China include a Phase 3 in IgAN and a Phase 2 study in lupus nephritis.

· Communications with the U.S. FDA about the potential of the clinical data package that led to the approval of ciprocopan in China for the treatment of PNH to support a marketing application for NXP100 in the U.S. are well underway and an update is expected by year-end; Nuvectis continues to explore additional opportunities and an IND submission, for an indication beyond PNH, is expected by year-end.

· Phase 3 results from a study conducted in China of a head-to-head comparison of NXP100 versus eculizumab (Soliris) in patients with PNH naïve to complement inhibition was presented at the (European Hematology Association 2026 conference), demonstrating a robust efficacy advantage of ciprocopan versus Soliris.

NXP200

· In September, NXP200 was granted Breakthrough Therapy Designation for the treatment of patients with BRAF V600-mutant, recurrent or progressive high-grade glioma by China’s Center for Drug Evaluation (CDE). In April, the project was selected as a pilot project under the "Pediatric Anti-tumor Drug R&D Encouragement Pilot Scheme (Starlight Program)" for the indication of pediatric BRAF V600-mutated recurrent or progressive glioma by CDE.

· In October, expanded NXP200 Phase 1b data in patients with recurrent or progressive BRAF V600-mutated gliomas were presented at the 2026 ESMO (Free ESMO Whitepaper) Congress. As of the May 4, 2026 cutoff, 27 efficacy-evaluable patients with recurrent or progressive BRAF V600 glioma were treated with NXP200 monotherapy, including 20 patients with high-grade glioma and 7 with low-grade glioma.

o Treatment with NXP200 resulted in an ORR of 40.0% in the high-grade glioma cohort, including 3 CRs (two confirmed and one preliminary) and 42.9% in the low-grade glioma cohort, including one confirmed CR. All response assessments were based on RANO 2.0 criteria. Notably, among the three patients previously treated with a BRAF inhibitor, two achieved a partial response and one had stable disease.

o Deep responses (>80% tumor burden reduction) were achieved in 87.5% of responders with high-grade glioma and 66.7% of responders with low-grade glioma. 81.5% of the patients in the study achieved a tumor reduction.

· A U.S. IND submission is expected by year-end.

· Updates from the ongoing Phase 1b study in China, including in additional tumor types, are expected in early 2027.

NXP900

· NXP900 Phase 1b clinical development continues to focus on combination opportunities:

o Non-small cell lung cancer (NSCLC): the clinical trials evaluating the combination of NXP900 plus osimertinib (Tagrisso) in patients with NSCLC EGFR+ and the combination with lorlatinib (Lorbrena) in patients with NSCLC ALK+ are ongoing. Update from Phase 1b expected during the first half of 2027.

o Pancreatic cancer: An investigator-sponsored trial to evaluate the combination of NXP900 plus the recently approved daraxonrasib in patients with pancreatic cancer is planned at two leading medical centers in the U.S.

Corporate Updates: Recent Hire Strenthens Our Clinical Development Team

Dustin Little, MD, joined Nuvectis as Senior Vice President, Head of the Complement program, in September 2026. Dr. Little is a physician-scientist and board-certified nephrologist with a decade of pharmaceutical industry experience driving drug development from asset acquisition through program design, regulatory submission and approval. From 2016-2026, Dr. Little worked at Astra Zeneca and most recently served as Global Clinical Head, Late Cardiovascular, Renal, and Metabolism (CVRM), providing clinical leadership for renal disease area strategy at AstraZeneca as well as multiple first-in-class/potential first-in-class treatments for people living with kidney, cardiovascular, or hematologic diseases. Dr. Little also represented AstraZeneca externally in regulatory interactions and on major industry, academic and drug development advisory bodies.

Dr. Little earned his doctorate degree from the University of Washington School of Medicine in 2007. Between 2007-2016 Dr. Little served in the US military during which time he completed his internal medicine residency at the Madigan Army Medical Center and nephrology fellowship at the Walter Reed National Medical Center. In 2013, Dr. Little deployed to Afghanistan as a squadron physician. Dr. Little continues to treat patients as a volunteer at a Washington, DC-area nephrology clinic.

Mr. Bentsur said, "We welcome Dustin to Nuvectis. Dustin has had an immediate impact on the NXP100 program including involvement in the FDA discussions for PNH, conducting prioritization assessments of other indications, protocol writing and interactions with top key opinion leaders. Dustin’s knowledge and understanding of the complement inhibition in nephrology and hematology diseases are exceptional and we look forward to harnessing his expertise as we set out to establish NXP100 as a potential best-in-class compound across several indications."

Dr. Little commented, "It’s exciting to join Nuvectis at such a transformative time. The company has built a strong foundation and NXP100, as a late-stage once-a-day oral CFBi, represents a unique opportunity for significant impact across several indications. Leveraging my industry experience and medical knowledge, I look forward to helping spearhead this program forward while utilizing the compelling NXP100 Chinese and other CFBi data as a roadmap for our development plans."

Third Quarter 2026 Financial Results

Cash and cash equivalents were $140.7 million as of September 30, 2026, compared to $31.6 million as of December 31, 2025. In July, the Company raised $115.0 million in gross proceeds in a follow-on offering and additional $39.5 million of cash was raised via the existing ATM of which $37.0 million placed with a single healthcare dedicated fund.

The Company’s net loss was $30.1 million for the three months ended September 30, 2026, compared to $7.5 million for the three months ended September 30, 2025, an increase in net loss of $22.6 million, which includes a one-time upfront payment associated with the NXP100 and NXP200 license agreement of $20.0 million, and $1.8 million in milestones associated with NXP900. Non-cash stock-based compensation was $2.4 million for the three months ended September 30, 2026, compared to $1.5 million for the three months ended September 30, 2025. Net of the up-front license payment, the one-time milestone associated with NXP900 and non-cash stock-based compensation, the net loss for the third quarter 2026 was $5.8 million.

Research and development expenses were $27.4 million for the three months ended September 30, 2026, compared to $5.8 million for the three months ended September 30, 2025, an increase of $21.6 million. The increase was primarily driven by the $20.0 million upfront payment for the NXP100 and NXP200 license agreement, $1.8 million in milestones associated with NXP900, a $1.2 million increase in employee compensation and benefits, $0.5 million increase in clinical trial expenses and a $0.1 million increase in manufacturing costs, partially offset by $2.0 million in license fees paid in 2025. Non-cash stock-based compensation was $1.5 million for the three months ended September 30, 2026, compared to $0.9 million for the three months ended September 30, 2025.

General and administrative expenses were $3.7 million for the three months ended September 30, 2026, compared to $2.0 million for the three months ended September 30, 2025, an increase of $1.7 million. The increase was primarily driven by a $1.2 million increase in professional and consulting services and a $0.4 million increase in employee compensation and benefits. Non-cash stock-based compensation was $0.9 million for the three months ended September 30, 2026, compared to $0.6 million for the three months ended September 30, 2025.

Finance income was $1.0 million for the three months ended September 30, 2026, and $0.3 million for the three months ended September 30, 2025.

Conference Call and Webcast Information:

Time: 8:00 AM ET

Date: Wednesday, November 4, 2026

Participant Dial-In (U.S.): 1-877-407-0752

Participant Dial-In (International): 1-201-389-0912

Conference ID: 13763643

Webcast Access: Please click here

(Press release, Nuvectis Pharma, NOV 4, 2026, View Source [SID1234674174])

Moleculin Announces Acceptance of Annamycin Data for Presentation at the 2026 American Society of Hematology (ASH) Annual Meeting

On November 4, 2026 Moleculin Biotech, Inc. (Nasdaq: MBRX) ("Moleculin" or the "Company") reported that an abstract highlighting data from its lead drug candidate, Annamycin, has been accepted for presentation at the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 12-15, 2026 in New Orleans, Louisiana.

The abstract, titled "A Pivotal Phase 2/3 Study of Naxtarubicin as Second Line Therapy in Patients with AML," presents results from the first prespecified interim analysis of the Company’s pivotal MB-108 Phase 2/3 trial evaluating Annamycin in combination with cytarabine (Ara-C) in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML).

Among the first 45 randomized patients evaluated, complete remission rates were 43% and 36% in the two Annamycin treatment arms, respectively, compared to 12% in the placebo arm. Consistent with findings across Annamycin’s clinical development program to date, no signs, symptoms or echocardiographic findings suggestive of cardiotoxicity were observed through the data cutoff. All cardiac safety data will undergo independent expert and independent Data Monitoring Committee review at the second interim analysis. Following its review, the independent Data Monitoring Committee recommended that the study continue without amendment, with all three treatment arms maintained.

"We are encouraged by these initial findings from our pivotal Phase 2/3 trial, particularly the remission rates observed in the Annamycin treatment arms. The independent Data Monitoring Committee’s recommendation to continue the study without modification represents an important milestone for the program. We look forward to sharing these findings with the broader hematology community at ASH (Free ASH Whitepaper) as we continue advancing Annamycin’s development for patients facing this challenging disease," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

The MIRACLE Trial (MB-108) is designed to confirm the efficacy and safety findings observed in the Company’s completed MB-106 Phase 1/2 trial and, if successful, could support a New Drug Application submission, consistent with the Company’s agreement with the U.S. Food and Drug Administration. As previously announced, the second interim analysis is expected in early 2027.

Presentation Details

Meeting: 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting
Abstract Title: A pivotal Phase 2/3 study of naxtarubicin as second line therapy in patients with AML
Presentation Type: Poster
Presenting Author: Oksana Karnabeda, MD, PhD, Arensia Exploratory Medicine, LLC
Location: Ernest N. Morial Convention Center – Hall F (Poster Hall), 900 Convention Center Blvd, New Orleans, LA 70130
The abstract will be available through the ASH (Free ASH Whitepaper) Annual Meeting website.

(Press release, Moleculin, NOV 4, 2026, View Source [SID1234674173])