On November 3, 2026 Amgen (NASDAQ:AMGN) reported financial results for the third quarter of 2026.

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"Amgen delivered another strong quarter as our strategy for long-term growth continued to produce results across the enterprise," said Robert A. Bradway, chairman and chief executive officer. "The strength of our commercial portfolio, combined with important clinical advances and a promising late-stage pipeline, reinforces our confidence in Amgen’s ability to deliver durable growth well into the next decade."

Key results include:
•For the third quarter, total revenues increased 8% to $10.4 billion in comparison to the third quarter of 2025.
◦Product sales grew 8%, driven by volume growth.
◦Seventeen products delivered at least double-digit sales growth in the third quarter.
◦Seventeen products are annualizing at more than $1 billion based on third quarter sales.
•GAAP earnings per share (EPS) increased 19% from $5.93 to $7.08 for the third quarter, driven by higher revenues.
◦For the third quarter, GAAP operating income increased from $2.5 billion to $3.7 billion, and GAAP operating margin increased 9.9 percentage points to 37.5%.
•Non-GAAP EPS increased 14% from $5.64 to $6.45 for the third quarter, primarily driven by higher revenues, partially offset by higher operating expenses.
◦For the third quarter, non-GAAP operating income increased from $4.3 billion to $4.7 billion, and non-GAAP operating margin increased 0.2 percentage points to 47.3%.
•The Company generated $3.7 billion of free cash flow in the third quarter of 2026 versus $4.2 billion in the third quarter of 2025, driven by changes in working capital, with the third quarter of 2025 benefiting from the timing of rebates and collections, partially offset by current period business performance.
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.

Product Sales Performance

General Medicine

•Repatha (evolocumab) sales increased 37% year-over-year to $1,085 million in the third quarter, primarily driven by volume growth.

•EVENITY (romosozumab-aqqg) sales increased 39% year-over-year to $751 million in the third quarter, driven by volume growth.

•Prolia (denosumab) sales decreased 45% year-over-year to $632 million in the third quarter as multiple biosimilars have launched globally. The decrease was driven by 23% lower volume with the remainder driven equally by lower net selling price and changes to estimated sales deductions.

Rare Disease

•TEPEZZA (teprotumumab-trbw) sales decreased 6% year-over-year to $526 million in the third quarter, driven by lower inventory levels.

•KRYSTEXXA (pegloticase) sales increased 31% year-over-year to $419 million in the third quarter, primarily driven by higher net selling price.

•UPLIZNA (inebilizumab-cdon) sales increased 191% year-over-year to $451 million in the third quarter, primarily driven by volume growth.

•TAVNEOS (avacopan) sales decreased 2% year-over-year to $105 million in the third quarter, driven by 9% lower volume, 8% unfavorable changes to estimated sales deductions and 5% lower net selling price, partially offset by higher inventory levels. We continue to engage with the U.S. Food and Drug Administration (FDA) and believe that TAVNEOS demonstrates clinical effectiveness and a favorable benefit-risk profile.

Inflammation

•TEZSPIRE (tezepelumab-ekko) sales increased 43% year-over-year to $538 million in the third quarter, driven by volume growth.

•Otezla (apremilast) sales decreased 18% year-over-year to $481 million in the third quarter, driven by 13% lower volume, 9% unfavorable changes to estimated sales deductions and 4% lower net selling price, partially offset by higher inventory levels.

•Enbrel (etanercept) sales increased 5% year-over-year to $611 million in the third quarter, driven by 15% favorable changes to estimated sales deductions and 8% higher inventory levels, partially offset by 14% lower net selling price, reflecting the ongoing impact of U.S. Medicare Part D price setting effective in 2026 under the Inflation Reduction Act, and lower volume.

•AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales increased 24% year-over-year to $191 million in the third quarter, primarily driven by 18% volume growth and higher net selling price.

•PAVBLU (aflibercept-ayyh) sales increased 41% year-over-year to $300 million in the third quarter, driven by 71% volume growth, partially offset by 18% lower net selling price.

Oncology

•BLINCYTO (blinatumomab) sales increased 27% year-over-year to $496 million in the third quarter, primarily driven by volume growth.

•IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab) sales increased 128% year-over-year to $406 million in the third quarter, driven by volume growth.

•Vectibix (panitumumab) sales increased 18% year-over-year to $335 million in the third quarter, primarily driven by volume growth.

•KYPROLIS (carfilzomib) sales decreased 8% year-over-year to $330 million in the third quarter, primarily driven by lower volume.

•LUMAKRAS/LUMYKRAS (sotorasib) sales increased 6% year-over-year to $102 million in the third quarter, driven by 14% volume growth, partially offset by 5% unfavorable changes to estimated sales deductions and lower inventory levels.

•Nplate (romiplostim) sales increased 3% year-over-year to $472 million in the third quarter. U.S. government orders were $65 million in Q3’26 compared to $90 million in Q3’25. Excluding these U.S. government orders, Nplate sales increased 11% year-over-year, primarily driven by volume growth.

•XGEVA (denosumab) sales decreased 47% year-over-year to $288 million in the third quarter as multiple biosimilars have launched globally. The decrease was primarily driven by 32% lower volume and 11% lower net selling price.

•MVASI (bevacizumab-awwb) sales decreased 21% year-over-year to $168 million in the third quarter, primarily driven by 11% lower net selling price and lower volume.

Established Products

•Our established products, which consist of Aranesp (darbepoetin alfa), Neulasta (pegfilgrastim), and Parsabiv (etelcalcetide), generated $606 million of sales in the third quarter. Sales increased 14% year-over-year, driven by 19% higher net selling price, partially offset by 3% lower volume.

Product Sales Detail by Product and Geographic Region
$Millions, except percentages Q3 ’26 Q3 ’25 YOY Δ
U.S.
ROW TOTAL TOTAL TOTAL
Repatha
$ 666 $ 419 $ 1,085 $ 794 37%
EVENITY
557 194 751 541 39%
Prolia
409 223 632 1,139 (45%)
TEPEZZA
441 85 526 560 (6%)
KRYSTEXXA
419 — 419 320 31%
UPLIZNA
352 99 451 155 *
TAVNEOS
105 — 105 107 (2%)
Ultra-Rare products(1)
107 3 110 200 (45%)
TEZSPIRE
538 — 538 377 43%
Otezla
428 53 481 585 (18%)
Enbrel
605 6 611 580 5%
AMJEVITA/AMGEVITA
64 127 191 154 24%
PAVBLU
294 6 300 213 41%
WEZLANA/WEZENLA
8 52 60 44 36%
BLINCYTO
269 227 496 392 27%
IMDELLTRA/IMDYLLTRA
224 182 406 178 *
Vectibix
182 153 335 284 18%
KYPROLIS
209 121 330 359 (8%)
LUMAKRAS/LUMYKRAS
55 47 102 96 6%
Nplate
347 125 472 457 3%
XGEVA
170 118 288 539 (47%)
MVASI
128 40 168 213 (21%)
Aranesp
95 234 329 357 (8%)
Neulasta
178 17 195 92 *
Parsabiv
38 44 82 84 (2%)
Other products(2)
371 49 420 317 32%
Total product sales $ 7,259 $ 2,624 $ 9,883 $ 9,137 8%
* Change in excess of 100%
(1) Ultra-Rare products consist of PROCYSBI, RAVICTI, ACTIMMUNE, QUINSAIR, and BUPHENYL.
(2) Other products consist of KANJINTI, AVSOLA, Aimovig, BKEMV/BEKEMV, RIABNI, EPOGEN, IMLYGIC, NEUPOGEN, DUEXIS, RAYOS, PENNSAID, Sensipar/Mimpara, and Corlanor. The Biosimilar products within Other products total $258 million in Q3 ’26 and $151 million in Q3 ’25. The Rare Disease products within Other products total $0 million in Q3 ’26 and ($10) million in Q3 ’25.

Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
•Total Operating Expenses decreased 5% year-over-year for the third quarter. Cost of Sales as a percentage of product sales decreased 5.5 percentage points, driven by lower amortization expense from acquisition-related assets and lower manufacturing costs, partially offset by higher profit share expense and changes in our sales mix. Research & Development (R&D) expenses increased 11% driven by higher spend in Research and Early Pipeline, including business development activity. Selling, General & Administrative (SG&A) expenses decreased 2% driven by lower general and administrative expenses, partially offset by higher commercial product-related expenses. Other operating expenses for the third quarter of 2026 totaled $76 million.
•Operating Margin as a percentage of product sales increased 9.9 percentage points to 37.5%.
•Tax Rate decreased 0.5 percentage points for the third quarter primarily driven by the change in earnings mix, including lower net unrealized gains on our equity investments, partially offset by net favorable items in the prior year as compared to the current year.
On a non-GAAP basis:
•Total Operating Expenses increased 8% year-over-year for the third quarter. Cost of Sales as a percentage of product sales increased 1.1 percentage points, driven by higher profit share expense and changes in our sales mix, partially offset by lower manufacturing costs. R&D expenses increased 11% driven by higher spend in Research and Early Pipeline, including business development. SG&A expenses decreased 1% driven by lower general and administrative expenses, partially offset by higher commercial product-related expenses.
•Operating Margin as a percentage of product sales increased 0.2 percentage points for the third quarter to 47.3%.
•Tax Rate decreased 2.3 percentage points for the third quarter primarily driven by the change in earnings mix.
$Millions, except percentages GAAP Non-GAAP
Q3 ’26 Q3 ’25 YOY Δ Q3 ’26 Q3 ’25 YOY Δ
Cost of Sales $ 2,788 $ 3,082 (10%) $ 1,907 $ 1,662 15%
% of product sales 28.2 % 33.7 % (5.5) pts. 19.3 % 18.2 % 1.1 pts.
Research & Development $ 2,111 $ 1,900 11% $ 2,105 $ 1,890 11%
% of product sales 21.4 % 20.8 % 0.6 pts. 21.3 % 20.7 % 0.6 pts.
Selling, General & Administrative $ 1,680 $ 1,720 (2%) $ 1,677 $ 1,700 (1%)
% of product sales 17.0 % 18.8 % (1.8) pts. 17.0 % 18.6 % (1.6) pts.
Other $ 76 $ 329 (77%) $ — $ — N/A
Total Operating Expenses $ 6,655 $ 7,031 (5%) $ 5,689 $ 5,252 8%
Operating Margin
Operating income as % of product sales
37.5 % 27.6 % 9.9 pts. 47.3 % 47.1 % 0.2 pts.
Tax Rate 17.5 % 18.0 % (0.5) pts. 15.9 % 18.2 % (2.3) pts.
pts: percentage points
N/A = not applicable

Cash Flow and Balance Sheet
•The Company generated $3.7 billion of free cash flow in the third quarter of 2026 versus $4.2 billion in the third quarter of 2025, driven by changes in working capital, with the third quarter of 2025 benefiting from the timing of rebates and collections, partially offset by current period business performance.
•The Company declared a third quarter 2026 dividend on July 30, 2026 of $2.52 per share that was paid on September 11, 2026 to all stockholders of record as of August 21, 2026, representing a 6% increase from the same period in 2025.
•During the third quarter of 2026, there were no repurchases of shares of common stock under our stock repurchase program.
•Cash and cash equivalents totaled $13.2 billion and debt outstanding totaled $54.0 billion as of September 30, 2026.
$Billions, except shares Q3 ’26 Q3 ’25 YOY Δ
Operating Cash Flow $ 4.2 $ 4.7 $ (0.4)
Capital Expenditures $ 0.6 $ 0.4 $ 0.2
Free Cash Flow $ 3.7 $ 4.2 $ (0.6)
Dividends Paid $ 1.4 $ 1.3 $ 0.1
Share Repurchases $ 0.0 $ 0.0 $ 0.0
Average Diluted Shares (millions) 546 542 4
Note: Numbers may not add due to rounding

$Billions 9/30/26 12/31/25 YTD Δ
Cash and Cash Equivalents $ 13.2 $ 9.1 $ 4.1
Debt Outstanding $ 54.0 $ 54.6 $ (0.6)
Note: Numbers may not add due to rounding

2026 Guidance
For the full year 2026, the Company expects:
•Total revenues in the range of $38.9 billion to $39.7 billion.
•On a GAAP basis, EPS in the range of $18.34 to $19.28, and a tax rate in the range of 14.5% to 16.0%.
•On a non-GAAP basis, EPS in the range of $22.90 to $23.70, and a tax rate in the range of 15.0% to 16.5%.
•Capital expenditures to be approximately $2.6 billion.
•Share repurchases not to exceed $3.0 billion.

Third Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:

General Medicine
MariTideTM (maridebart cafraglutide/AMG 133)
•MariTide is a differentiated antibody-peptide conjugate that activates the glucagon-like peptide-1 (GLP-1) receptor and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR). MariTide’s long-acting design supports starting with monthly dosing, and staying on MariTide with as few as four or six doses per year.
•MARITIME-1, a Phase 3 study of MariTide for chronic weight management, is ongoing in adults living with obesity or overweight, without Type 2 diabetes (T2D).
•MARITIME-2, a Phase 3 study of MariTide for chronic weight management, is ongoing in adults living with obesity or overweight, with T2D.
•MARITIME-CV, a Phase 3 study of MariTide on cardiovascular (CV) outcomes, has completed enrollment of adults living with established atherosclerotic cardiovascular disease and obesity or overweight.
•MARITIME-HF, a Phase 3 study of MariTide on reduction of heart failure (HF) events and cardiovascular risk, is enrolling adults living with heart failure with preserved or mildly reduced ejection fraction and obesity.
•MARITIME-OSA-1, a Phase 3 study of MariTide, has completed enrollment of adults living with obstructive sleep apnea (OSA) on positive airway pressure therapy and living with obesity or overweight.
•MARITIME-OSA-2, a Phase 3 study of MariTide, has completed enrollment of adults living with OSA not on positive airway pressure therapy and living with obesity or overweight.
•MARITIME-SWITCH, a Phase 3 study of MariTide, is enrolling adults living with obesity or overweight who will be switching from weekly tirzepatide or weekly semaglutide to MariTide on an every eight-week or quarterly dosing schedule.
•MARITIME-1 EXTENSION, a Phase 3 long-term extension study of MariTide, to evaluate the maintenance of weight loss with monthly, every eight-week or quarterly dosing, is enrolling adults living with obesity or overweight without T2D who completed the MARITIME-1 study.
•MARITIME-2 EXTENSION, a Phase 3 long-term extension study of MariTide, to evaluate the maintenance of weight loss with monthly and every eight-week dosing, is enrolling adults living with obesity or overweight with T2D who completed the MARITIME-2 study.
•MARITIME-T2D-3 study, a Phase 3 study of MariTide, to evaluate efficacy compared to semaglutide, was initiated and is enrolling adults living with T2D.
•Two additional Phase 3 studies of MariTide in people living with T2D will be initiated in Q4 2026.
•A Phase 2b study of MariTide to assess the effect of MariTide on liver fat reduction and weight loss has completed enrollment of adults living with obesity or overweight with elevated liver fat.
Repatha
•In August, results from a new pre-specified analysis of the Phase 3 VESALIUS-CV pre-cardiovascular event trial on the protective effects of Repatha on fatal outcomes were presented at the European Society of Cardiology (ESC) Congress.
◦In this study, Repatha was associated with a nominal:
▪20% reduction in all-cause mortality
▪21% reduction in cardiovascular death

15% reduction in non-cardiovascular death, largely explained by lower rates of non-fatal myocardial infarction, stroke, and ischemia-driven revascularization
◦Repatha also demonstrated that the reduction in mortality began around 1.5 years after treatment and continued through a median 4.6 years of follow-up.
•In August, results from a new pre-specified analysis of the Phase 3 VESALIUS-CV trial on the protective effect of Repatha on total cardiovascular events were also presented at ESC Congress. In this study, Repatha:
◦reduced the total number of MACE (major adverse cardiac events), providing support for the role of intensive low-density lipoprotein cholesterol lowering to prevent first and subsequent MACE in patients at high cardiovascular risk and no prior MI or stroke
◦demonstrated a 27% relative reduction in the risk of a composite of coronary heart disease death, heart attack or ischemic stroke (3-P MACE)
◦demonstrated a 20% reduction in a broader composite that also included ischemia-driven revascularization (4-P MACE)
•EVOLVE-MI, a Phase 4 study of Repatha initiated within 10 days of an acute myocardial infarction to reduce the risk of cardiovascular events, is ongoing.
Olpasiran (AMG 890)
•Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver.
•The OCEAN(a)-Outcomes trial, a Phase 3 secondary prevention CV outcomes study, is ongoing in patients with established atherosclerotic CV disease and elevated Lp(a).
•The OCEAN(a)-PreEvent trial, a Phase 3 primary prevention CV outcomes study, is enrolling patients with elevated Lp(a) at high risk for a first major CV event.
•The OCEAN(a)-Coronary Computed Tomography Angiography (CCTA), a Phase 3 coronary artery plaque study, is enrolling patients with atherosclerotic CV disease and elevated Lp(a).

Rare Disease
UPLIZNA
•MERCURY, a Phase 2/3 study of UPLIZNA, was initiated in patients with autoimmune hepatitis (AIH).
•MOMENT, a Phase 3 study of UPLIZNA, was initiated in patients with primary membranous nephropathy (PMN).
•In September, new one-year extension data from the Phase 3 MINT study in patients with generalized myasthenia gravis (gMG) were presented at Annual Neuromuscular Study Group (NMSG) and at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. Key findings included:
◦sustained numerical improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores at Year 1 of the open label period (OLP)

◦observed improvements both in participants who continued UPLIZNA from the randomized controlled period (RCP) and in those who initiated UPLIZNA during the OLP, demonstrating similar patterns of improvement regardless of initial treatment assignment
◦UPLIZNA continued to demonstrate a safety profile consistent with the established safety profile of UPLIZNA across all approved indications
◦efficacy and safety outcomes support the longer-term use of UPLIZNA for the treatment of gMG
•A Phase 3 study of UPLIZNA in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) will be initiated H2 2026 – H1 2027.
TEPEZZA
•Chronic-J, a Phase 3 study of TEPEZZA in Japanese patients with chronic thyroid eye disease (TED) met both primary endpoints, with a safety profile consistent with the established profile. The results will be shared with the scientific community and regulatory authorities.
TAVNEOS
•The Company continues to engage the U.S. Food and Drug Administration (FDA) regarding the Center for Drug Evaluation and Research’s request to voluntarily withdraw TAVNEOS from the U.S. market. On June 1, 2026, the Company requested a hearing to discuss this topic and submitted supporting materials to the FDA on July 23, 2026. The Company believes that these materials support a favorable benefit-risk profile of TAVNEOS for patients with AAV.
•A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen is ongoing in patients from six years to < 18 years of age with active AAV (Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA)).
Dazodalibep
•Dazodalibep is a fusion protein that inhibits CD40 ligand (CD40L).
•In October, the Company announced results from the Phase 3 OASIZ-301 study of dazodalibep in adults with Sjögren’s disease and moderate-to-severe systemic disease activity with full results to be presented as a late-breaking oral presentation at the American College of Rheumatology (ACR) Convergence in November. In this study, dazodalibep:
◦achieved statistically significant and clinically meaningful improvements of systemic disease activity at Week 48 with a change from baseline of 5.6 points with every-four-week dosing (1.8 points placebo-adjusted improvement) and 5.2 points with every-12-week dosing (1.4 points placebo-adjusted improvement), as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI)
◦observed evidence of clinical benefit as early as Week 4
◦demonstrated statistically significant and clinically meaningful improvements of patient-reported dryness, a key secondary endpoint, at Week 48 with a change from baseline of 2.50 points (1.17 points placebo-adjusted improvement) and 1.98 points (0.93 points placebo-adjusted improvement) with every-four-week dosing, as measured by the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) dryness score and the Diary for Assessing Sjögren’s Patient Reported Index (DASPRI) dryness score, respectively
◦demonstrated a favorable safety profile that was similar across treatment groups
•OASIZ 303, the Phase 3 study of dazodalibep in Sjögren’s patients with moderate-to-severe symptom burden with low systemic disease activity, is ongoing and is expected to complete in Q4 2026.
AMG 732
•AMG 732 is an insulin-like growth factor-1 receptor (IGF-1R) targeting monoclonal antibody.
•A Phase 2 study of AMG 732 is ongoing in patients with moderate-to-severe active TED.

Inflammation
Otezla
•A Phase 3 study evaluating the safety of Otezla in pediatric patients aged six through 17 years with mild to moderate plaque psoriasis, has been completed. The safety findings were consistent with the established safety profile of Otezla. The Company plans to submit the results to the FDA.
TEZSPIRE
•In October, the results from the Phase 3 CROSSING study of TEZSPIRE in eosinophilic esophagitis (EOE) were presented at the American College of Gastroenterology (ACG) and the United European Gastroenterology Week (UEGW). In this study, TEZSPIRE dosed every four weeks:
◦achieved histologic remission at Week 24 in 64.8% and 68.9% of EoE patients receiving the 210 mg and 420 mg doses, respectively, vs 3.5% for placebo
◦reduced the frequency and severity of dysphagia symptoms at Week 24 by 18.8 points and 22.0 points in EoE patients receiving 210 mg and 420 mg doses, respectively, vs 14.7 points for placebo, as measured by the Dysphagia Symptom Questionnaire (DSQ) score
◦sustained histological remission and continued symptom improvement through Week 52
◦achieved total endoscopic remission at Week 52 in 34.4% and 29.5% of EoE patients receiving the 210 mg and 420 mg doses, respectively, vs 4.1% for placebo
◦demonstrated a safety profile consistent with its approved indications
•Two Phase 3 studies of TEZSPIRE are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a blood eosinophil count (BEC) ≥ 150 cells/µL.
Daxdilimab
•Daxdilimab is a first-in-class plasmacytoid dendritic cell depleting monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7).
•In September, results from the Phase 2 study of daxdilimab in adult patients with moderate-to-severe primary discoid lupus erythematosus (DLE) were presented at the European Academy of Dermatology and Venereology (EADV). In this study, daxdilimab dosed every four weeks:

◦achieved statistically significant and clinically meaningful improvements in disease activity by 10.2 points with low dose (6.0 points placebo-adjusted improvement) and 9.9 points with high dose (5.7 points placebo-adjusted improvement), as measured by the change from baseline of the Cutaneous Lupus Erythematosus Disease Area and Severity Index – Activity (CLASI-A) score at Week 24
◦showed statistically significant improvement in disease activity as early as Week 4 with the low dose and Week 8 with the high dose
◦demonstrated a ≥50% reduction in CLASI-A score (CLASI-50) at Week 24 in 61.7% of patients on low dose (38.0% placebo-adjusted improvement) and 62.1% of DLE patients on high dose (38.4% placebo-adjusted improvement)
◦achieved a clear or almost-clear skin at Week 24 in 60.3% of patients on low dose (51.5% placebo-adjusted improvement) and 51.6% of DLE patients on high dose (42.8% placebo-adjusted improvement), as measured by the proportion of patients achieving the Cutaneous Lupus Activity Investigator’s Global Assessment (CLA-IGA 0/1)
◦demonstrated a favorable safety profile, with no serious adverse events or deaths reported
•The Company is taking steps to advance daxdilimab to Phase 3 development.
Blinatumomab
•Blinatumomab is a bispecific T-cell engager (BiTE) molecule targeting CD19.
•A Phase 2 study of blinatumomab in autoimmune disease is enrolling adults with refractory rheumatoid arthritis.
•A Phase 2 study of blinatumomab in autoimmune disease is ongoing in adults with systemic lupus erythematosus (SLE), with and without nephritis.
Inebilizumab
•Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19.
•A Phase 2 study of inebilizumab in autoimmune disease has completed enrollment of adults with SLE with nephritis.
Sunakiment (AMG 104/AZD8630)
•Sunakiment is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab) protein.
•The Company is planning a Phase 3 development program in asthma in collaboration with AstraZeneca.

Oncology
BLINCYTO/blinatumomab
•Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is ongoing in older adult patients with newly diagnosed CD19-positive Philadelphia chromosome (Ph) negative B-cell precursor acute lymphoblastic leukemia (B-ALL).
•A potentially registration-enabling Phase 2 study of subcutaneous blinatumomab in both adults and adolescents with relapsed or refractory CD19-positive Ph-negative B-ALL remains on partial clinical hold by the FDA.
•A Phase 1b/2 study of subcutaneous blinatumomab in pediatric patients with relapsed or refractory and minimal residual disease positive (MRD+) B-ALL remains on partial clinical hold by the FDA.
•Discussions are underway with the FDA on a path forward to reopen both subcutaneous blinatumomab studies.
IMDELLTRA/tarlatamab
•IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule.
•In September, the FDA approved an update to the IMDELLTRA Prescribing Information, reducing the recommended monitoring time for the first two doses from 22 to 24 hours to 6 to 8 hours from the start of infusion in an appropriate healthcare setting.
•In September, at the World Conference on Lung Cancer (WCLC), two key IMDELLTRA results were presented:
◦A Phase 2 alternate dosing study, DeLLphi-309, evaluating IMDELLTRA dosed every three weeks or every four weeks, demonstrated durable objective response and maintained overall survival (OS) in both dosing frequencies compared to the established every 2 week dosing. Extended dosing regimens may offer flexibility in treatment combination for small cell lung cancer (SCLC) patients who are often taking other therapies.
◦Results from the Phase 1b DeLLphi-308 subcutaneous administration study showed for the first time that subcutaneous IMDELLTRA can achieve comparable exposures to the intravenous route, to be further characterized in the Phase 3 DeLLphi-315 study
•In October, three key IMDELLTRA results were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress:
◦The landmark Phase 3 DeLLphi-305 study showed that addition of IMDELLTRA to IMFINZI (durvalumab) in first-line maintenance therapy significantly improved OS (58% reduction in risk of death) and progression-free survival (66% reduction in risk of disease progression or death) for patients who completed initial chemo-immunotherapy without progression. The DeLLphi-305 results were published simultaneously in the New England Journal of Medicine.
◦IMDELLTRA continued to demonstrate a safety profile consistent with the established safety profile of IMDELLTRA in the approved second-line setting
◦A long-term update with a median follow-up of 30.8 months from the Phase 1b DeLLphi-303 first-line maintenance study, showed an estimated median OS of 37.9 months among patients that received IMDELLTRA plus a PD-L1 inhibitor as a first-line maintenance regimen following initial chemo-immunotherapy
◦A long-term update from the Phase 3 DeLLphi-304 study, which established IMDELLTRA as the standard of care for patients who have had progression on or after platinum-based chemotherapy, showed sustained OS benefit with twice as many patients alive at two years with IMDELLTRA (30%) compared to standard chemotherapy (15%). The DeLLphi-304 results were published simultaneously in Annals of Oncology.
•The Company is advancing a comprehensive, global clinical development program across extensive-stage (ES) and limited-stage (LS) SCLC:

◦DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with a PD-L1 inhibitor alone, is ongoing in patients with first-line ES-SCLC
◦DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is ongoing in patients with LS-SCLC
◦DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second-line or later ES-SCLC
◦DeLLphi-310, a Phase 1b study of IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate (ADC), with or without a PD-L1 inhibitor, is ongoing in patients with ES-SCLC
◦DeLLphi-311, a Phase 1b study of IMDELLTRA in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), is ongoing in patients with second-line or later ES-SCLC
◦DeLLphi-312, a Phase 3 study of IMDELLTRA in combination with carboplatin, etoposide and durvalumab, has completed enrollment of patients with first-line ES-SCLC
◦DeLLphi-313, a Phase 1b study of IMDELLTRA in combination with zocilurtatug pelitecan, a DLL3 targeting ADC, with and without a PD-L1 inhibitor, is enrolling patients with ES-SCLC
◦DeLLphi-315, a Phase 3 study of subcutaneous tarlatamab, is enrolling patients with second-line ES-SCLC
Xaluritamig (AMG 509)
•Xaluritamig is a first-in-class BiTE molecule targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1).
•XALute, a Phase 3 study of xaluritamig, is ongoing in patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy.
•XALience, a Phase 3 study of xaluritamig in combination with abiraterone, is enrolling patients with chemotherapy-naïve mCRPC.
•A Phase 1 study of xaluritamig monotherapy and xaluritamig in combination with abiraterone is enrolling patients with mCRPC who have not yet received taxane-based chemotherapy. Results from a fully outpatient cohort of patients with mCRPC who have previously received taxane-based chemotherapy were presented at ESMO (Free ESMO Whitepaper), demonstrating feasibility for a more convenient administration setting.
•A Phase 1b study of neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high‐risk prostate cancer.
•A Phase 1b study of xaluritamig is ongoing in patients with high-risk biochemically recurrent prostate cancer after definitive therapy.
•A Phase 1b study of xaluritamig in combination with androgen receptor pathway inhibitors is enrolling patients with metastatic hormone-sensitive prostate cancer.
•A Phase 1b study of xaluritamig is enrolling adults with mCRPC to evaluate an additional dosing regimen.

•A Phase 1b study of xaluritamig is enrolling adult, adolescent and pediatric patients with relapsed or refractory Ewing sarcoma.
LUMAKRAS/LUMYKRAS
•CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI vs. FOLFIRI with or without bevacizumab-awwb, is enrolling patients with first-line KRAS G12C–mutated metastatic colorectal cancer.
•CodeBreaK 202, a Phase 3 study of LUMAKRAS plus platinum doublet chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced non-small cell lung cancer (NSCLC).
Nplate
•PROCLAIM, a Phase 3 study of Nplate for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients with NSCLC, ovarian cancer, or breast cancer is complete. Full results will be presented at an upcoming medical congress.
•ROMISTER, a Phase 3 study of Nplate plus predniso(lo)ne compared with predniso(lo)ne alone, is enrolling patients with untreated primary immune thrombocytopenia (ITP).

Biosimilars
•A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO (nivolumab) is ongoing in patients with treatment-naïve unresectable or metastatic melanoma. The Biologics License Application (BLA) with the FDA has been submitted and accepted for review. The Company expects an FDA action on this BLA by the end of the year.
•A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared with KEYTRUDA (pembrolizumab) in patients with advanced or metastatic non-squamous NSCLC has met both primary and secondary endpoints. We have submitted these results and are awaiting file acceptance by the FDA.
•A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA in patients with early-stage non-squamous NSCLC as adjuvant treatment has met both primary and secondary endpoints.
•A randomized, double-blind, pharmacokinetic similarity/comparative clinical study of ABP 692 compared with OCREVUS (ocrelizumab) is ongoing in patients with relapsing-remitting multiple sclerosis.
•A randomized, double-blind, comparative clinical study of ABP 938 (8 mg) compared with EYLEA HD (aflibercept) is enrolling patients with neovascular age-related macular degeneration.

TEZSPIRE is being developed in collaboration with AstraZeneca.
Sunakiment (AMG 104/AZD8630) is being developed in collaboration with AstraZeneca.
Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc.
YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink.
Zocilurtatug pelitecan is an investigational DLL3 targeting antibody-drug conjugate being developed by Zai Lab Limited.
Etakafusp alfa (AB248) is a novel CD8+ T cell selective IL-2 being developed by Asher Biotherapeutics.
OPDIVO is a registered trademark of Bristol-Myers Squibb Company.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
OCREVUS is a registered trademark of Genentech, Inc.
EYLEA HD is a registered trademark of Regeneron Pharmaceuticals, Inc.
IMFINZI is a registered trademark of AstraZeneca PLC.

(Press release, Amgen, NOV 3, 2026, View Source [SID1234674084])

On November 3, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated cell therapies for solid tumors, reported the presentation of updated safety and efficacy data from the EVEREST-2 (NCT06051695) and DENALI-1 (NCT06682793) clinical studies. The data includes updates on the first reported case of complete response (CR) to CAR T-cell therapy in a patient with non-small cell lung cancer (NSCLC) in the EVEREST-2 study, as well as the first reported case of complete response in a patient with metastatic anal cancer and a partial response with disease control for six months in a patient with refractory head and neck squamous cell cancer (HNSCC) from the DENALI-1 study. The results are being presented at the 41st Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) taking place November 4–8, 2026, in Phoenix. The EVEREST-2 abstract (#559) was recognized as a Top 150 Abstract.

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Complete responses have rarely been observed in studies of CAR T-cell therapies for the treatment of solid tumors, and none has been reported in patients with lung cancer.1

"Our NSCLC patient achieved a systemic complete response that remains ongoing after more than 12 months of follow-up. These findings from the EVEREST-2 study support the potential of precision cell therapy targeting mesothelin-expressing s in solid tumors, such as NSCLC, mesothelioma, pancreatic, ovarian, and colorectal cancer," said Salman R. Punekar, M.D., Medical Director of Solid Tumor Cell Therapy, NYU Langone Health, Perlmutter Cancer Center.

EVEREST-2 (NCT06051695) is first-in-human, open-label, Phase 1/2 study evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2). A2B694 is an autologous, logic-gated, TmodTM CAR T-cell therapy combining a mesothelin (MSLN) CAR T activator with an HLA-A*02 blocker to enhance tumor selectivity. A2B543 uses the same TmodTM construct with an NFAT-driven, membrane-tethered IL-12 (mem-IL-12) booster designed to enhance TmodTM potency and persistence while limiting systemic IL-12 exposure.

Few treatment advancements have been made for anal cancer. Standard EGFR-targeted therapies can cause severe toxicities,2 and surgical treatments can impact a patient’s quality of life.

Head and neck cancers are the seventh most common cancer worldwide, and high rates of morbidity and mortality are associated with this disease.3

"Our head and neck cancer patient treated in DENALI-1 had previously received several lines of therapy for a painful, softball-size tumor in their neck and had no response to those other treatments. After receiving A2B395, pain from the tumor resolved and the tumor shrank enough to allow them to return to work, making it the first time since diagnosis that the patient has not required regular chemotherapy. The partial response and minimal toxicity from the treatment resulted in a profound improvement of the patient’s quality of life," said Matthew Ulrickson, M.D., Chief, Section of Hematology, Banner MD Anderson Cancer Center.

DENALI-1 (NCT06682793) is a first-in-human, open-label, Phase 1/2 study evaluating the safety and recommended Phase 2 dose of A2B395 in adults with previously treated EGFR-positive advanced solid tumors. DENALI-1 is currently enrolling patients with recurrent unresectable, locally advanced, or metastatic solid tumors associated with EGFR expression. A2B395 represents the first non–HLA-matched allogeneic CAR T-cell therapy with an unmodified, unselected T-cell receptor (TCR) and a blocker designed to mitigate graft-versus-host disease (GVHD) risk.

"We are encouraged by the results from our ongoing DENALI-1 and EVEREST-2 studies, which continue to build clinical evidence of safety and efficacy of our investigational TmodTM-based CAR T-cell therapies. Following a single dose of A2B395, heavily pre-treated patients with refractory anal cancer and head and neck cancer achieved a complete response and a partial response, respectively. We are also encouraged by the findings for our MSLN-targeted autologous CAR T-cell therapy A2B694, including a complete response by central review in a patient with refractory lung cancer. Together, these results provide early proof-of-concept that our TmodTM-based CAR T-cell therapies – both autologous and allogeneic approaches – can safely treat patients with complex, advanced solid tumors," said John Welch, M.D., Ph.D., chief medical officer, A2 Bio.

The study abstracts are available online on the SITC (Free SITC Whitepaper) website.

EVEREST-2: Study Findings

As of September 1, 2026, 16 patients were enrolled in EVEREST-2. Three patients were enrolled in Arm 2, receiving A2B543, the IL-12 boosted TmodTM CAR T-cell therapy, at dose level 1 (4 × 10⁸ cells). All three patients were women (ages 45, 45, and 51 years) with pancreatic cancer. 13 patients were enrolled in Arm 1, receiving A2B694 (without the IL-12 booster) across 4 dose levels (1–6 × 10⁸ cells). Median age was 59 years. Tumor types included colorectal cancer (n=4), pancreatic cancer (n=3), ovarian cancer (n=3), non–small cell lung cancer (n=1), gastroesophageal cancer (n=1), and mesothelioma (n=1)

A2B543 and A2B694 demonstrated manageable safety and tolerability in all 16 patients. The safety findings to date are consistent with the intended logic-gated design, with no dose-limiting toxicities (DLTs) or grade 4 TmodTM CAR T cell–related AEs reported. In Arm 2 (A2B543), there was one case of grade 1 cytokine release syndrome (CRS). In Arm 1 (A2B694), there was one case each of grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS), grade 1 ICANS and grade 1 CRS.
In Arm 2, the two evaluable pancreatic cancer patients at dose level 1 had best overall responses of stable disease (SD). In Arm 1, among 13 evaluable patients, the best responses were CR (n=1; non–small cell lung cancer), SD (n=8), and progressive disease (PD) (n=4). The CR was confirmed at Day 90 by central review per RECIST 1.1 and remains ongoing after more than 12 months of follow-up.
A2B543 was associated with higher TmodTM expansion than most A2B694-treated patients. Serum IL-12 remained in normal range <5 pg/mL through Day 56 in both patients treated with A2B543.
The maximum tolerated dose has not been reached.
DENALI-1: Study Findings

As of August 21, 2026, 11 patients received A2B395 in DENALI-1. Tumor types included anal cancer (n=1), head and neck cancer (n=1), non–small cell lung cancer (n=2), colorectal cancer (n=4), and breast cancer (n=3). The median age was 56 years (range, 33–70), and 80% of patients were women.

A2B395 was well tolerated with no DLTs, GVHD, or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). One patient experienced grade 1 CRS and one experienced grade 2; both fully resolved. On-target, off-tumor toxicities were manageable and consistent with the intended tumor-selective design of logic-gated TmodTM.
Antitumor activity was observed with A2B395. One patient with unresectable anal cancer after five 5 prior chemotherapy regimens and two courses of radiation therapy, received A2B395 at DL3 and achieved a CR on Day 28, with resolution of all target and non-target lesions and no serious adverse events.
One patient with refractory head and neck cancer after multiple prior therapies received A2B395 at DL2 and achieved a PR on Day 180, with ongoing disease control at 6 months.
Among nine efficacy-evaluable patients, best responses were CR (n=1), PR (n=1), SD (n=5), and PD (n=2), for a disease control rate of 78%.
A2B395 was detected in peripheral blood and biopsies in all treated patients
The maximum tolerated dose has not been reached.
Poster Presentation Details

Abstract Title Presenting Author Abstract Number Poster Presentation Date Location
Non-gene edited, allogeneic, EGFR-targeted CAR T using a logic-gate to prevent on-target, off-tumor toxicity and mitigate GVHD: initial data from the DENALI-1 study of A2B395 in advanced solid tumors Matthew Ulrickson, M.D., Banner MD Anderson Cancer Center 527 Friday, Nov. 6
12:15 – 1:45 pm MT
5:30 – 7:00pm MT PCC-North Building- Lower Level- Exhibition Halls 4-5-6
Armoring logic-gated CAR T cells with a membrane-tethered IL-12 booster: initial data from the EVEREST-2 study of A2B543 in advanced solid tumors Salman Punekar, M.D.,
New York University Langone Health,
Perlmutter Cancer Center 559
About EVEREST-2

The EVEREST-2 master protocol (NCT06051695) is a seamless Phase 1/2 study evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2), autologous logic-gated investigational cell therapies developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets MSLN and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. A2B543 contains the same Tmod construct as A2B694 with an added mem-IL-12 booster. The EVEREST-2 study is enrolling adults with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression. Patients are enrolled through BASECAMP-1 (NCT04981119), a master prescreening study that identifies patients with HLA LOH at any time in the course of their disease via next-generation sequencing. Upon disease progression, the participant may screen for enrollment in EVEREST-2.

About DENALI-1

DENALI-1 (NCT06682793) is a phase 1/2, multicenter, open-label, nonrandomized study evaluating the safety and efficacy of A2B395, an allogeneic logic-gated Tmod CAR T-cell therapy. Patients are enrolled through BASECAMP-1 (NCT04981119), a master prescreening study that identifies patients with HLA LOH at any time in the course of their disease via next-generation sequencing. Upon disease progression, the participant may screen for enrollment in DENALI-1. A2B395 uses a Tmod logic-gate: an activator targeting EGFR and a blocker targeting HLA-A*02. In patients with HLA-A*02 loss of heterozygosity (LOH), the blocker inhibits both CAR and endogenous T-cell receptor (TCR) activity on normal tissue, providing tumor selectivity without gene editing, reducing on-target, off-tumor toxicity, and mitigating graft-versus-host disease. DENALI-1 is currently enrolling adults with recurrent unresectable, locally advanced, or metastatic colorectal, non-small cell lung, triple-negative breast, head and neck squamous cell, and renal cell cancer, or other solid tumors associated with EGFR expression. Patients are not required to undergo leukapheresis to receive treatment on DENALI-1 because A2B395 is an allogeneic treatment.

About BASECAMP-1

BASECAMP-1 (NCT04981119) is a prescreening study to identify patients for potential treatment in A2 Bio clinical trials. It is a novel approach to help optimize patient treatment outcomes by enabling patients’ immune cells to be banked in their healthiest state earlier in their course of cancer treatment. Next-generation sequencing is used to identify patients who have lost HLA-A*02 heterozygosity in the tumor, the biomarker of interest for the A2 Bio studies. Patients eligible for autologous therapy undergo leukapheresis to collect, process, and store patient T cells for future Tmod CAR T cell therapy. BASECAMP-1 is currently enrolling patients with non-small cell lung cancer, pancreatic cancer, ovarian cancer, colorectal cancer, mesothelioma, head and neck squamous cell carcinoma, triple-negative breast cancer, renal cell carcinoma, and other solid tumors.

About the Tmod Platform

A2 Bio has pioneered a precision-targeting cellular system – the Tmod platform – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized, and effective T-cell targeting. The blocker component equips Tmod cells with the capacity to identify tumors as distinct from normal cells.

(Press release, A2 Biotherapeutics, NOV 3, 2026, View Source [SID1234674083])

On November 2, 2026 Eikon Therapeutics, Inc. (Nasdaq: EIKN) ("Eikon"), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, reported that Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer and Board Chair of Eikon Therapeutics, will participate in the JP Morgan Chase Biotech Call series and a Guggenheim Investor Conference as listed below:

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Event: JP Morgan Biotech Call Series
Location: Boston, MA
Date & Time: November 6, 2026 at 2:00 pm EST
Format: Presentation

Event: Guggenheim 3rd Annual Healthcare Innovation Conference
Location: Boston, MA
Date & Time: November 10, 2026 at 8:00 pm EST
Format: Fireside Chat

In addition, Chief Medical Officer, Roy Baynes, M.D., Ph.D., will participate in the Morgan Stanley Biotech Webcast in November:

Event: Post-ESMO: New Data & the Evolving Synthetic Lethality Landscape
Location: New York City, NY
Date & Time: November 3, 2026 at 10:30 am EST
Format: Call

Live audio/video webcasts of these presentations will be accessible through Eikon’s investor relations website at investors.eikontx.com, with an archived edition of the session available later that day and accessible for approximately 30 days after the live event.

(Press release, Eikon Therapeutics, NOV 2, 2026, View Source [SID1234674069])

On November 2, 2026 NeOnc Technologies Holdings (NASDAQ: NTHI) reported a story that could prove far more meaningful.

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The clinical-stage biopharmaceutical company is advancing potential treatments for some of the most difficult-to-treat brain cancers while building an ambitious clinical development strategy that could reach approximately 500 patients across 30 hospitals in three countries.

Now, NeOnc is preparing to bring its research into the international spotlight and today the company announced that data from both its intranasal NEO100 and oral NEO212 programs will be presented at the 31st Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), taking place November 12–15 at the Pennsylvania Convention Center in Philadelphia.

The two poster presentations, scheduled for November 13, represent an important opportunity to showcase the progress of both clinical programs before a specialized audience of neuro-oncology researchers and physicians.

For investors, the timing adds another dimension to an already developing story involving innovative drug delivery, preliminary clinical observations, international development ambitions, and potentially significant market interest.

Two Clinical Programs. One Major Neuro-Oncology Meeting.

NeOnc’s announcement is particularly interesting because it involves two distinct investigational approaches targeting challenging central nervous system cancers.

Presentation Number 1: NEO100 and Updated Clinical Observations is titled: "Durable Radiographic Remission and Prolonged Survival with Intranasal NEO100 in Recurrent WHO Grade III/IV IDH1-Mutant Astrocytoma: Updated Results from a Phase 1/2a Study and Compassionate Use Experience."

Thomas C. Chen, MD, PhD, of the University of Southern California and NeOnc Technologies Holdings, will present the findings.

The title alone makes this presentation particularly noteworthy. It focuses on updated results involving recurrent WHO Grade III/IV IDH1-mutant astrocytoma, an aggressive category of brain cancer where treatment options remain challenging.

Importantly, the presentation combines information from a Phase 1/2a study and compassionate-use experience.

The emphasis on durable radiographic remission and prolonged survival makes the updated findings worth watching, although the presentation’s title should not be interpreted as proof of established treatment efficacy.

For NeOnc, the presentation offers an opportunity to provide additional scientific context around its intranasal treatment approach and the clinical observations generated to date.

Presentation Number 2: NEO212 and TMZ-Resistant Brain Cancer, "Oral NEO212 in TMZ-Resistant Recurrent GBM and Brain Metastases: Phase 1 Safety, PK, and Early Signals of Activity."

Josh Neman, PhD, of the University of Southern California and NeOnc Technologies Holdings, will present the research.

This presentation examines NEO212 in the context of recurrent glioblastoma that is resistant to temozolomide (TMZ), as well as brain metastases.

The focus on Phase 1 safety, pharmacokinetics (PK), and early signals of activity is significant because it provides an opportunity to examine how the investigational oral treatment is being evaluated in difficult-to-treat CNS cancers.

NEO212 has completed Phase 1 dose escalation and is advancing toward Phase 2 development.

The two presentations demonstrate that NeOnc is not relying on a single investigational candidate to drive its development strategy.

Instead, the company is advancing two distinct programs that could offer different approaches to addressing the challenges of brain cancer treatment.

NEO100: A Different Approach to Getting Treatment into the Brain

At the center of NeOnc’s development strategy is NEO100, a highly purified form of perillyl alcohol administered intranasally.

The delivery approach is designed to provide a non-invasive route to the brain.

That matters because one of the greatest obstacles in developing treatments for brain cancer is the blood-brain barrier.

The blood-brain barrier serves as the brain’s natural protective defense system, but that protection also creates a major obstacle for drug developers. Many potential therapies struggle to reach tumors in sufficient concentrations because of this biological barrier.

NeOnc is investigating a different approach.

Rather than relying exclusively on conventional delivery methods, its NEO100 program investigates intranasal administration as a potential way to deliver treatment toward the brain, where drug delivery remains one of the biggest obstacles to therapeutic progress.

Early Clinical Observations Give the Story a Foundation

The upcoming SNO presentation follows earlier clinical observations that have attracted attention.

The company’s appearance on Health Uncensored with Dr. Drew on Fox Business Network also brought the patient experience into the conversation.

One patient described reaching two years on therapy and reported tolerating treatment without reactions.

During the discussion, when Dr. Drew asked about the tumor’s status, physician Dr. Wallace responded, "We can’t see it, actually, at this moment."

It was a striking moment, illustrating why continued research in this field matters. For families facing aggressive brain cancer, the objective isn’t simply another clinical milestone or a better number on a presentation slide.

It is more time together. Another birthday. Another anniversary. Another opportunity to experience everyday life.

The upcoming presentation could provide additional information as the company continues evaluating NEO100.

NEO212: Another Potential Piece of the Brain Cancer Strategy

While NEO100 is attracting attention for its intranasal delivery approach, NEO212 represents another important component of NeOnc’s development strategy.

NEO212 is an investigational oral conjugate of temozolomide and NEO100, which is being studied for central nervous system cancers, including recurrent glioblastoma.

The company’s upcoming SNO presentation will focus on Phase 1 safety, pharmacokinetics, and early signals of activity in TMZ-resistant recurrent glioblastoma and brain metastases.

NEO212 is being developed under an FDA investigational new drug application.

Its completion of Phase 1 dose escalation and progression toward Phase 2 development represent important steps in the company’s broader clinical strategy.

Together, NEO100 and NEO212 give NeOnc two investigational programs to advance, with different administration approaches and areas of clinical investigation.

For investors following the company, the November 13 presentations could provide an important opportunity to learn more about both programs.

A 500-Patient Ambition That Changes the Conversation

The SNO announcement comes against the backdrop of NeOnc’s broader clinical ambitions.

During its appearance on Health Uncensored with Dr. Drew on Fox Business Network, the company outlined plans for a pivotal clinical trial targeting approximately 500 patients across 30 hospitals in three countries.

A proposed trial of that scale is not a small undertaking. It represents a planned expansion of NeOnc’s clinical ambitions and an opportunity to investigate its treatment approach in a much larger patient population.

The proposal also signals where management wants to take the program and the upcoming SNO presentations provide another opportunity to build scientific visibility as NeOnc works toward its longer-term objectives.

More Than Drug Development: A Broader Technology and International Story

NeOnc’s ambitions also extend beyond conventional drug development.

Its research platform combines patented 3D bioprinting technology with artificial intelligence to create patient-derived tumor models and help researchers evaluate potential treatments, which could support a more personalized understanding of tumor biology and treatment response.

The company also highlighted molecular characteristics, including IDH mutations, as part of its precision-medicine strategy.

For the market, the broader takeaway is that NeOnc is building a story around several interconnected capabilities:

Investigational drug development through NEO100 and NEO212.
Innovative intranasal and oral delivery approaches.
Patient-derived tumor modeling.
AI-assisted research.
Precision-medicine development.
International clinical and business ambitions.
The company’s international ambitions have also been reinforced by developments in Abu Dhabi, including the appointment of Ali Alabedin, Head of Islamic Banking Group at First Abu Dhabi Bank, to the company’s board.

These developments add an international dimension to a company whose clinical ambitions are increasingly extending beyond a single market.

Now Comes the Interesting Part for Traders: Potential Short Squeeze

While the clinical story is compelling on its own, NTHI has another ingredient that could make its shares particularly interesting to traders: short interest.

Based on Nasdaq’s October 15 market-data snapshot, approximately 877,000 shares were reported short.

At the same time, the stock had recovered from an approximate $2.50 low to eclipse the $3 level, where the potential trading implications become interesting.

The reported short position represents approximately 5.6 days of trading volume using the referenced ten-day average. Five or more days to cover is the sweet spot. If short sellers needed to cover 500,000 shares over a relatively short period, that would represent more than three full days of average trading volume.

That is a meaningful amount of potential buying demand relative to the cited trading activity.

The Technical Levels That Could Make a Difference

Based on the recent trading information cited in the original investment analysis, the $3.30–$3.40 area represents an important initial zone to watch.

Above that, the recent high near $3.55 becomes another potential technical hurdle.

A sustained move through that level, particularly if accompanied by expanding trading volume, could attract momentum traders and potentially increase pressure on short positions.

Wall Street’s Price Targets Add Another Layer

Published analyst coverage has also placed considerably higher values on NTHI.

Roth Capital analyst Jonathan Aschoff initiated coverage with a Buy rating and a $20 price target.

The valuation thesis included projected future commercial potential for NEO100 and NEO212, with anticipated launches in 2029 and 2030, respectively, according to the analyst’s model.

Cantech Letter’s summary of the research cited projected 2033 operating income of $667 million.

These figures represent analyst assumptions and projections rather than established financial results or guaranteed future valuations.

Nevertheless, they illustrate the potential commercial opportunity envisioned in the bullish investment thesis if NeOnc’s programs successfully progress through clinical development and ultimately achieve commercialization.

That question could become increasingly relevant as additional milestones arrive.

For a clinical-stage company developing treatments for difficult-to-treat brain cancers, having two investigational programs represented at the same scientific meeting is a meaningful development and it also gives the investment community two distinct areas of research to follow rather than a single clinical catalyst.

The Bigger Picture: Investing in What Matters

There are plenty of companies competing for attention in today’s stock market. Some are selling the promise of faster computers, more powerful chips, or the next generation of artificial intelligence.

NeOnc is pursuing something different and is attempting to advance potential therapies for patients facing one of medicine’s most challenging diseases while developing technology designed to improve how researchers understand tumors and investigate treatment possibilities.

The company’s story now brings together two investigational drug programs, upcoming scientific presentations, a proposed 500-patient international clinical trial, an innovative intranasal delivery strategy, patented research technology, and international relationships.

Add the potential commercial opportunity outlined in analyst research and the trading dynamics associated with previously reported short interest, and NTHI has several developments that investors may want to monitor.

The November 13 SNO presentations could be particularly important because they bring both clinical programs into the scientific spotlight at the same time.

And for patients and families confronting aggressive brain cancers, the ultimate measure of success will be whether promising research can eventually translate into safer and more effective treatment options.

(Press release, Neonc, NOV 2, 2026, View Source [SID1234674068])

On November 2, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel therapies for difficult-to-treat cancers, reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 19/669,218, titled "Oral Dosage Forms of Elraglusib." The allowed claims cover the composition of oral tablet forms of elraglusib, an inhibitor of GSK-3β, the Company’s lead clinical investigational candidate, including the optimized Elraglusib Oral Tablet developed for upcoming use in clinical trials.

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Elraglusib Oral Tablet is being developed to enable convenient daily dosing with the potential to provide sustained GSK-3β inhibition, leading to enhanced antitumor activity. Pre-clinical and clinical exposure-effect analysis has identified threshold plasma levels of elraglusib associated with clinical benefit, inhibition of tumor growth and reduction in tumor size. Sustained exposure of elraglusib has been observed to elicit direct effects on tumor cells as well as a unique array of complementary effects on anti-tumor immune response that lead to increased CD8+ and NK cell recruitment, attenuation of immune suppressive features and altering the tumor immune microenvironment to prime the tumor for sustained anti-tumor immune response. To date, elraglusib has been administered intravenously (Elraglusib Injection) using weekly or twice weekly intermittent dosing in several clinical studies in refractory and resistant adult and pediatric cancers.

Elraglusib Oral Tablet is a key part of Actuate’s clinical development strategy, with potential utility as a monotherapy and in combination treatment and maintenance therapy approaches. Actuate plans to initiate a Phase 1/2 clinical trial of Elraglusib Oral Tablet in the first quarter of 2027 to evaluate its safety, tolerability, pharmacokinetics and screen for initial evidence of antitumor activity in patients with advanced cancer.

"The development of an optimized oral tablet dosage form marks an important advance in realizing elraglusib’s therapeutic potential," said Daniel Schmitt, President and Chief Executive Officer of Actuate Therapeutics. "Daily oral administration is expected to enable sustained plasma drug exposure and inhibition of GSK-3 in a tumor, potentially promoting sustained changes in immune cell dynamics that favor antitumor immune responses. This approach could also provide greater dosing flexibility and patient convenience and expand opportunities to investigate elraglusib as both a monotherapy and in combination with other cancer treatments."

"The allowance of this patent application represents an important milestone in strengthening our intellectual property portfolio around oral formulations of elraglusib including protection for the oral tablet dosage form," said Andrew Mazar, PhD, Chief Operating Officer at Actuate Therapeutics. "With our imminent Phase 1/2 clinical trial, we anticipate being able to more fully explore the clinical potential of elraglusib in the next stage of development as we bring a new oral treatment option with a unique immunomodulatory mechanism of action to cancer patients in need."

The patent, upon completion of customary USPTO procedures, is expected to further strengthen Actuate’s intellectual property portfolio, support continued stage appropriate development, leading to the future potential commercialization of oral elraglusib.

(Press release, Actuate Therapeutics, NOV 2, 2026, https://www.globenewswire.com/news-release/2026/11/02/3393067/0/en/actuate-therapeutics-receives-u-s-notice-of-allowance-for-patent-covering-elraglusib-oral-tablets.html [SID1234674067])