On November 5, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported financial results for the quarter ended September 30, 2026, and highlighted continued progress in the development of micvotabart pelidotin (MICVO).

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"The September monotherapy data reinforce our confidence in MICVO’s potential to serve a significant population of patients with previously treated recurrent/metastatic head and neck cancer," said Tom Civik, Chief Executive Officer and Chairman of Pyxis Oncology. "We have aligned with feedback received from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the design of the global Phase 3 HeadlinerSM trial and plan to initiate it in mid-2027, with FDA feedback on dose selection expected in the first quarter of 2027. We look forward to presenting MICVO monotherapy data, along with two preclinical posters, at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium in November, and providing a comprehensive update on our head and neck cancer strategy in December, including updated efficacy and safety data from MICVO in combination with pembrolizumab in the first-line setting. Our strengthened balance sheet positions us to execute on these priorities, continue evaluating MICVO’s broader potential and advance toward becoming a pre-commercial organization."

Pipeline Updates

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Pyxis Oncology has aligned with feedback from the FDA and the EMA on the design of the global pivotal Phase 3 HeadlinerSM trial, which the Company plans to initiate in mid-2027. The randomized, open-label, two-arm trial will evaluate MICVO monotherapy in patients with second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) who have progressed following treatment with both platinum-based chemotherapy and an anti-PD-1 therapy. Approximately 500 patients are expected to be randomized 1:1 to receive MICVO or investigator’s choice of cetuximab, docetaxel or methotrexate. The co-primary endpoints are overall response rate and overall survival.

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Pyxis Oncology expects to provide an update in the first quarter of 2027 on FDA feedback regarding dose selection following its End-of-Phase 2 meeting.

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Updated overall survival data from the ongoing MICVO monotherapy study are expected in the first half of 2027.

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Additional data from the Phase 1/2 combination study of MICVO and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in first-line (1L) R/M HNSCC, including initial durability data to inform selection of the recommended Phase 3 dose, are expected in the second half of 2027.

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Reported Updated Phase 1 Monotherapy Data in 2L+ R/M HNSCC

On September 9, 2026, Pyxis Oncology announced updated data from its ongoing global Phase 1 monotherapy study of MICVO in 2L+ R/M HNSCC, as of a data cutoff of August 18, 2026.

In the efficacy-evaluable population receiving MICVO at 5.4 mg/kg intravenously once every three weeks (IV Q3W) at or below a dose cap (N=33):

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Confirmed objective response rate was 36% (12/33), and disease control rate was 94% (31/33).

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Responses were rapid and deep, with 75% of responders responding by the first scan at six weeks and 83% of responders achieving greater than 50% tumor reduction.

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Median progression-free survival was 6.2 months (95% CI: 4.8–8.8), and the 12-month overall survival probability was 79% (95% CI: 58.1, 90.3). Median overall survival had not yet been reached.

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Clinical activity was observed across HPV status and prior-treatment subgroups.

In the safety-evaluable population (N=35), no new safety signals were observed. Dose capping reduced the frequency and severity of adverse events in high body weight patients.

Planned December 2026 Corporate Update

Pyxis Oncology plans to provide a corporate update in December 2026, including:

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A comprehensive development strategy for MICVO in R/M HNSCC, including how emerging combination data inform potential opportunities across treatment settings.

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Updated efficacy and safety data from the ongoing Phase 1/2 combination dose-escalation study evaluating MICVO with KEYTRUDA (pembrolizumab) across multiple doses in 1L R/M HNSCC.

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The update is expected to include data from a total of at least 20 patients with 1L R/M HNSCC treated with MICVO at the 3.6 mg/kg and 4.4 mg/kg dose levels in combination with a fixed dose of 200 mg of pembrolizumab. Durability data are expected in the second half of 2027.

Corporate Updates

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In September 2026, Pyxis Oncology appointed Tom Civik Chief Executive Officer and Chairman of the Board. Mr. Civik had served as Interim Chief Executive Officer since February 2026 and has been a member of the Board since 2021. John Flavin, co-founder and founding Chairman of Pyxis Oncology, transitioned to Lead Independent Director and continues to serve on the Board.

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On October 1, 2026, Pyxis Oncology closed a registered public offering that generated approximately $110.0 million in upfront gross proceeds, before deducting underwriting discounts and commissions and other offering expenses. The offering also included milestone-linked warrants that, if exercised in full for cash, would provide approximately $172.6 million in additional gross proceeds, for a total of up to approximately $282.6 million. The Company believes its cash, cash equivalents, restricted cash and short-term investments as of September 30, 2026, together with the net upfront proceeds from the offering, will be sufficient to fund operations into the first half of 2028. Additional details about the offering and accompanying warrants are available in the Company’s October 2, 2026 announcement.

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At the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place November 18–20, 2026, in Barcelona, Spain, Phase 1 clinical data for MICVO monotherapy in previously treated R/M HNSCC will be presented by Faye M. Johnson, M.D., Ph.D., of The University of Texas MD Anderson Cancer Center, in a late-breaking oral presentation on November 19. Pyxis Oncology will also present preclinical findings in two poster presentations on November 18, further characterizing MICVO’s extracellular mechanism of action and evaluating MICVO in combination with EGFR-targeted therapy. These findings inform the Company’s broader development strategy for MICVO.

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Tom Civik, Chief Executive Officer and Chairman of the Board, will participate in fireside chats at two upcoming investor conferences. Live webcasts and replays of the fireside chats will be available on the Events & Presentations page in the Investor Relations section of Pyxis Oncology’s website, ir.pyxisoncology.com.

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Guggenheim 3rd Annual Healthcare Innovation Conference: Monday, November 9, 2026, at 9:00 a.m. ET in Boston, MA.

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Stifel 2026 Healthcare Conference: Tuesday, November 10, 2026, at 4:40 p.m. ET in New York, NY.

Third Quarter 2026 Financial Results

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As of September 30, 2026, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $57.0 million. After considering net proceeds from the registered public offering, the company believes our cash, cash equivalents, restricted cash and marketable debt securities will be sufficient to fund our operations into the first half of 2028.

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Research and development expenses were $16.6 million for the quarter ended September 30, 2026, compared to $17.8 million for the quarter ended September 30, 2025. The decrease was primarily due to a reduction of $3.6 million in manufacturing costs, partially offset by a $3.0 million increase in clinical trial expenses related to monotherapy and combination therapy of MICVO.

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General and administrative expenses were $4.0 million for the quarter ended September 30, 2026, compared to $5.7 million for the quarter ended September 30, 2025. The decrease was primarily attributable to a $1.4 million decrease in stock-based compensation expense.

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Net loss was $20.0 million, or ($0.24) per common share, for the quarter ended September 30, 2026, compared to $22.0 million, or ($0.35) per common share, for the quarter ended September 30, 2025. The $2.0 million year-over-year decrease in net loss primarily reflected a $1.7 million reduction in non-cash stock-based compensation expense.

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As of November 4, 2026, the outstanding number of shares of Common Stock of Pyxis Oncology was 119,607,855.

About Micvotabart Pelidotin (MICVO)

Micvotabart pelidotin (MICVO, formerly PYX-201) is an investigational antibody-drug conjugate (ADC) that uniquely targets extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix. MICVO is designed to generate a multi-pronged attack on difficult-to-treat cancers by directly killing cancer cells, reducing extracellular matrix density, inhibiting tumor angiogenesis and mobilizing an anti-tumor immune response.

MICVO received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy.

(Press release, Pyxis Oncology, NOV 5, 2026, View Source [SID1234674322])

On November 5, 2026 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the third quarter ended September 30, 2026, and provided a corporate update.

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"The third quarter was a defining period for Protagonist, with FDA approval of MIMRYLO, our second approval this year for a first-in-class peptide drug, and the continued strong commercial launch of ICOTYDE under our collaboration with Johnson & Johnson," said Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics. "MIMRYLO reflects years of disciplined scientific dedication and clinical execution, and together with ICOTYDE, provides immensely important validation both of our innovative expertise in peptide therapeutics and of the successful pharma-biotech partnership model we have built around these two approved drugs. The partnerships are fueling an accelerating revenue engine, which provides the flexibility to fund the next generation of wholly owned programs emerging from our platform, and to return meaningful capital to shareholders through a share repurchase program."

Third Quarter 2026 Recent Developments and Upcoming Milestones

MIMRYLO (rusfertide): Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera

· On August 28, Protagonist announced that its partner Takeda received U.S. Food and Drug Administration (FDA) approval of MIMRYLO for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is the first and only hepcidin mimetic peptide therapy approved for this indication. On September 30, 2026, MIMRYLO was also approved in the United Arab Emirates. Protagonist discovered MIMRYLO and had primary responsibility for its clinical development through its New Drug Application ("NDA") filing in December 2025.

· The FDA approval of MIMRYLO triggered $275 million in payments to Protagonist, consisting of a $200 million opt-out payment and a $75 million approval milestone.

· Following Protagonist’s April 2026 opt-out election, Takeda holds exclusive worldwide development and commercialization rights to MIMRYLO. Protagonist is eligible to receive tiered royalties ranging from 14% to 29% on worldwide net sales, corresponding to an approximately 21% weighted-average royalty rate at $1.5 billion in annual net sales. Protagonist is eligible for up to an additional $875 million in potential future milestone payments.

· On October 13, 2026, results from the pivotal Phase 3 VERIFY study were published in the Journal of Clinical Oncology. The article is available here.

ICOTYDE (Icotrokinra): Oral IL-23 Receptor Antagonist

· During the third quarter, ICOTYDE received regulatory approvals in China, Japan and the European Union for the treatment of psoriasis, following U.S. FDA approval in March 2026. ICOTYDE is the first and only targeted oral peptide designed to precisely block the IL-23 receptor.

· On October 14, 2026, results from the Phase 2 ANTHEM-UC study were published in the New England Journal of Medicine. The article is available here.

· The third quarter of 2026 represents ICOTYDE’s second full quarter of U.S. commercial sales. Under the collaboration with Johnson & Johnson, Protagonist receives tiered royalties ranging from 6% to 10% on global net sales, with an approximate 7.25% weighted-average royalty rate at $4 billion in annual net sales and a 10% tier applying to incremental annual sales above $4 billion. Protagonist is eligible for up to an additional $580 million in potential future milestone payments.

· In September and October 2026, Johnson & Johnson presented two-year Phase 3 results from the ICONIC-TOTAL and ICONIC-LEAD studies. The results demonstrated sustained responses through Week 112 and a continued favorable safety profile in adults and adolescents with plaque psoriasis, including patients with disease affecting high-impact and difficult-to-treat areas.

· ICOTYDE is also in development for additional immune-mediated diseases, including psoriatic arthritis, ulcerative colitis and Crohn’s disease.Wholly-Owned Clinical and Discovery Programs

· PN-881 (oral IL-17 antagonist peptide for immune-mediated disease): The Phase 1 study of PN-881 has been completed. PN-881 achieved 24-hour trough concentrations several-fold above prospectively targeted IC90 values for IL-17AA, IL-17FF and IL-17AA+FF with once-daily oral dosing and was generally well tolerated, with no serious adverse events. Protagonist plans to initiate a comprehensive Phase 2b dose range-finding study in patients with plaque psoriasis in early Q1 2027. Phase 1 data are expected to be presented at a future medical meeting.

· PN-477 (triple GLP-1/GIP/GCG agonist peptide for obesity): In the subcutaneously administered PN-477sc Phase 1 SAD study we observed positive dose-related pharmacokinetic, pharmacodynamic and clinical activity. Based on these highly encouraging findings, the Company has made a strategic decision to prioritize the orally administered PN-477o clinical development program. Initiation of a Phase 1 study of oral PN-477o is anticipated in the first half of 2027.

· PN-458o (dual GLP-1/GIP agonist peptide for obesity): IND-enabling studies are ongoing, with Phase 1 initiation anticipated in the second half of 2027.

· PN-8047 (oral small molecule hepcidin functional mimetic for PV): IND-enabling studies are ongoing, with Phase 1 initiation anticipated in Q1 2027.

· Discovery: The Company continues to advance high-priority discovery programs for oral peptides, including an oral IL-4Rα antagonist and amylin-based mono- and poly-agonists.

Share Repurchase Program

· On September 8, Protagonist announced that its Board of Directors authorized a share repurchase program under which the Company may repurchase up to $300 million of its outstanding common stock. The Company intends to fund repurchases from its cash, cash equivalents and marketable securities, as well as royalties and other payments received under its collaboration arrangements with Takeda related to MIMRYLO and Johnson & Johnson related to ICOTYDE. The timing and amount of any repurchases will depend on market conditions, alternative capital deployment opportunities and other factors.

Third Quarter 2026 Financial Results

· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2026, were $834.6 million as compared to $646.0 million as of December 31, 2025.Three Months Ended Nine Months Ended
September 30, September 30,
(in thousands, except per share amounts) 2026 2025 2026 2025
License and collaboration revenue $ 274,410 $ 4,712 $ 544,253 $ 38,579
Research and development expense $ 41,274 $ 40,003 $ 130,074 $ 112,932
General and administrative expense $ 13,704 $ 11,130 $ 39,629 $ 33,419
Income tax expense $ 6,556 $ – $ 7,319 $ 172
Net income (loss) $ 220,015 $ (39,339 ) $ 386,647 $ (85,765 )
Basic earnings (loss) per share $ 3.32 $ (0.62 ) $ 5.88 $ (1.35 )
Diluted earnings (loss) per share $ 3.07 $ (0.62 ) $ 5.43 $ (1.35 )

· License and Collaboration Revenue: License and collaboration revenue was $274.4 million for the third quarter of 2026. This revenue was primarily driven by the proportional recognition of $266.6 million related to the $275.0 million earned from Takeda during the quarter. These payments, which were received in cash in October 2026, consisted of a further $200.0 million opt-out fee and a separate $75.0 million milestone triggered by the FDA approval of MIMRYLO. The remaining $7.8 million was derived from ongoing development services provided by us under the Takeda Collaboration Agreement, and other revenues.

· License and collaboration revenue was $544.3 million for the nine months ended September 30, 2026. This cumulative revenue consisted primarily of $460.5 million related to total proportional revenue recognized from Takeda during those nine months. Additionally, the nine-month revenue includes $33.8 million derived from ongoing development services provided by us under the Takeda Collaboration Agreement, a $50.0 million milestone earned from Johnson & Johnson in Q1 2026 upon FDA approval of ICOTYDE, and other revenues.

License and collaboration revenue of $4.7 million for the third quarter of 2025 was comprised of development services we provided under the Takeda collaboration agreement. License and collaboration revenue of $38.6 million for the nine months ended September 30, 2025, was comprised of (i) proportional recognition of a $25 million milestone earned from Takeda in Q1 2025, and (ii) development services we provided during the period.

· Research and Development ("R&D") Expense: The increases in R&D expense from the prior year periods were primarily due to our clinical development and pre-clinical discovery programs, partially offset by decreases in rusfertide expenses related to the Phase 3 VERIFY clinical trial. We expect our R&D expenses to increase for the remainder of the year as compared to the prior quarters in 2026. The increase is expected to be driven primarily by the advancement of PN-881 into a comprehensive Phase 2 psoriasis program, planned investments in clinical manufacturing and CMC activities, including at-risk expenditures to ensure readiness for other programs as they advance into clinical development (PN-477o, PN-458, PN-8047), additional pre-clinical discovery programs, as well as an increase in headcount and stock-based compensation expense.

· General and Administrative ("G&A") Expense: The increases in G&A expense from the prior year periods were primarily due to increases in stock-based compensation and other personnel-related expenses.

· Net Income (Loss): Net income was $220.0 million, or $3.32 per basic share and $3.07 per diluted share, for the third quarter of 2026 as compared to net loss of $39.3 million, or $0.62 per basic and diluted share, for the third quarter of 2025. Net income was $386.6 million, or $5.88 per basic share and $5.43 per diluted share, for the nine months ended September 30, 2026, as compared to net loss of $85.8 million, or $1.35 per basic and diluted share, for the nine months ended September 30, 2025.

(Press release, Protagonist, NOV 5, 2026, View Source [SID1234674321])

On November 5, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company developing therapeutics using its proprietary INTASYL gene-silencing technology to eliminate cancer, reported financial results for the quarter ended September 30, 2026, and provided a business update.

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"We have successfully executed on critical development objectives to advance the PH-762 program toward Phase 2b study initiation," said Robert J. Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals. "Commercial-scale drug substance manufacturing was completed and shipped to our drug product manufacturer in preparation for making clinical trial supply material. We have submitted detailed information to FDA providing final analysis of our Phase 1b clinical trial and the fundamentals of our intended upcoming Phase 2b study."

PH-762 Development Update

PH-762 was evaluated in a U.S. multicenter Phase 1b dose-escalation clinical trial assessing intratumoral administration in patients with cutaneous squamous cell carcinoma (cSCC), melanoma, and Merkel cell carcinoma. The study (NCT 06014086) was designed to evaluate the safety and tolerability of neoadjuvant treatment with PH-762, assess tumor response, and identify a dose or dose range for further clinical development. The study enrolled 22 patients, consisting of 20 patients with cutaneous squamous cell carcinoma, one patient with melanoma, and one patient with Merkel cell carcinoma.

The clinical trial was completed in June 2026, and the final clinical study report was submitted to FDA with a meeting request and briefing document outlining the nonclinical and clinical pharmacology programs, scientific rationale for continued development, completed Phase 1b results, and details of the planned Phase 2b neoadjuvant study in cSCC. The submission seeks FDA feedback on the proposed development strategy and next steps, with a response expected from the FDA by the end of November 2026.

The Company also announced the successful release of its first commercial-scale cGMP batch of PH-762 drug substance (active pharmaceutical ingredient), representing an important CMC (chemistry, manufacturing and controls) milestone that supports the planned Phase 2b clinical program, which is expected to be initiated in the first quarter of 2027.

Scientific and Corporate Activities

During the quarter, the Company presented PH-762 Phase 1b clinical trial data at scientific and investor conferences and roadshows. These included the Life Sciences Future Conference, King of Prussia, PA, H.C. Wainwright Conference, NYC, NIBA 153rd Conference, Fort Lauderdale, FL, Life Sciences Virtual Investor Conference, and Renmark Financial Virtual Non-Deal Roadshows.

The Company further strengthened its intellectual property position through multiple patent-related achievements during the quarter. Phio’s patent portfolio currently includes 56 issued patents and 34 pending applications worldwide, providing broad protection for its INTASYL self-delivering RNAi therapeutic platform and product candidates through at least 2038, with additional pending applications extending potential protection into 2044.

Financial Results

Cash Position

As of September 30, 2026, we had cash and cash equivalents of $10.6 million as compared with $21.0 million at December 31, 2025. The Company continues to focus its resources on advancing PH-762 while prudently managing general and administrative expenses.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2026 were $3.0 million, an increase of $1.9 million or 159%, compared with the three months ended September 30, 2025. The increase was primarily driven by a $1.5 million increase in nonclinical toxicology study costs, drug substance costs and clinical supplies costs as compared to the clinical study costs that occurred during the prior year period, and a $0.3 million increase in other development related costs.

Research and development expenses for the nine months ended September 30, 2026 were $8.9 million, an increase of $5.8 million or 180% as compared with the nine months ended September 30, 2025. The increase in research and development expenses was primarily driven by a $4.5 million increase in nonclinical toxicology study costs, drug substance costs and clinical supplies costs, all of which were associated with advancing the PH-762 program. In addition, research and development expenses increased by approximately $0.3 million related to employee headcount costs, $0.6 million related to outside services and consultants and $0.2 million related to patent activity.

Management believes that research and development expenses will continue to increase as we advance our PH-762 program.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2026 were $1.2 million, a decrease of $100 thousand or 9%, compared with the three months ended September 30, 2025. This decrease was primarily driven by a reduction in outsourced consulting services.

General and administrative expenses for the nine months ended September 30, 2026 increased 6% or $200 thousand as compared with the nine months ended September 30, 2025. The increase was primarily driven by a $1.2 million increase in employee costs, of which $0.7 million related to increased stock-based compensation expenses. This increase was partially offset by a $1.1 million decrease in outside services and consultant expenses as compared to the prior year period.

Net Loss

Net loss was $4.2 million for the three months ended September 30, 2026 as compared with $2.4 million for the three months ended September 30, 2025. The increase in net loss was attributable to higher research and development expenses associated with advancing the PH-762 program.

(Press release, Phio Pharmaceuticals, NOV 5, 2026, View Source [SID1234674320])

On November 5, 2026 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biotechnology company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported financial results for the third quarter ended September 30, 2026.

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"NKX019 is advancing in our two lead indications, myositis and systemic sclerosis," said Paul J. Hastings, Chief Executive Officer of Nkarta. "We’re delighted to have been selected to present our initial clinical data in two oral presentations and one poster presentation at ACR Convergence 2026 in Orlando. We believe that the safety profile of engineered CAR-NK cells could broaden cell therapy access to reach far more patients. With off-the-shelf availability and outpatient dosing at a growing network of community-based sites, our program is designed to deliver on that potential."

NKX019 Clinical Program Progress and Upcoming Milestones

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Initial clinical data from the Ntrust program to be presented at ACR Convergence 2026 in the company’s lead indications: idiopathic inflammatory myopathy and systemic sclerosis. Presentations include an oral presentation in myositis on November 8, a poster in systemic sclerosis on November 9, and an oral presentation of safety data across autoimmune indications on November 11.
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Enrollment continues in the Ntrust program, our multi-center, open-label, dose-escalation clinical trials evaluating NKX019 in multiple autoimmune diseases.
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Outpatient dosing is underway within our network of community-based sites, extending access to patients who cannot travel to academic medical centers.
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Patients are being dosed at 4 billion cells per dose x 3 doses (12 billion cells total) across all indications in Ntrust-1 and Ntrust-2.

Third Quarter 2026 Financial Highlights

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Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $216.0 million as of September 30, 2026.
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Research and development (R&D) expenses were $29.5 million for the third quarter of 2026. Non-cash stock-based compensation expense included in R&D expense was $0.7 million for the third quarter of 2026.
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General and administrative (G&A) expenses were $6.3 million for the third quarter of 2026. Non-cash stock-based compensation expense included in G&A expense was $1.1 million for the third quarter of 2026.
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Net loss was $33.3 million, or $0.45 per basic and diluted share, for the third quarter of 2026. This net loss includes non-cash charges of $2.8 million that consisted primarily of share-based compensation and depreciation expenses.

Financial Guidance

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Nkarta expects its current cash and cash equivalents to fund its current operating plan into 2029.

About the Ntrust℠ Clinical Trials in Autoimmune Disease

Ntrust-1 (NCT06557265) and Ntrust-2 (NCT06733935) are multi-center, open-label, dose-escalation clinical trials in patients with autoimmune disease receiving lymphodepletion followed by CD19-targeted CAR-NK cell therapy. Both trials assess the safety of NKX019 in people living with autoimmune diseases as well as its potential to achieve durable remission via a "reset" of the immune system through the elimination of pathogenic B cells.

The Ntrust trials are enrolling up to 12 patients per dose level per disease indication, with leading indications in myositis and systemic sclerosis, as well as ANCA-associated vasculitis, rheumatoid arthritis, lupus nephritis, and primary membranous nephropathy. Additional patients may be enrolled if needed to refine patient populations for further study.

In both studies, patients receive a three-dose cycle of NKX019 following lymphodepletion with fludarabine and cyclophosphamide or cyclophosphamide alone, if they have significant cytopenia at baseline. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval. Patients in both trials may also receive additional cycles, if needed, to restore response or enable a deeper response.

About NKX019

NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease. Nkarta is evaluating NKX019 in multiple autoimmune conditions.

(Press release, Nkarta, NOV 5, 2026, View Source [SID1234674319])

On November 5, 2026 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the third quarter ended September 30, 2026.

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"The last quarter marks a tremendously important step forward for our clinical portfolio, with a positive readout from the GFORCE-1 study of MRT-8102, the initiation of Phase 2 development for MRT-2359, and the advancement of our partnered VAV1 program into two Phase 2 studies," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "The GFORCE-1 results reinforce our view that targeting NEK7 at the top of the NLRP3 signaling cascade could address a broader set of disease drivers than targeting individual downstream cytokines. Our planned Phase 2 studies in coronary artery disease (CAD), gout, and hidradenitis suppurativa, conditions with major unmet needs, are intended to deepen our understanding of the therapeutic potential of NEK7 degradation. In CAD, our innovative study design integrates molecular and imaging-based readouts to explore how MRT-8102’s broad biological activity translates into changes in coronary plaque biology, to inform patient selection and design for an efficient future Phase 3 study."

Dr. Warmuth continued: "We are particularly excited about the opportunity in gout, where there is a substantial unmet need for effective flare prevention that is well tolerated with prolonged use. With the emergence of next-generation urate-lowering drugs and their propensity to induce flares in the first 6 to 12 months of use, we believe the need for a well-tolerated, non-immunosuppressive flare prevention treatment will only increase. We expect initial data from our Phase 2 gout study in H2 2027. Across the broader pipeline, we are pursuing a focused development strategy for MRT-2359 through MODeFIRe-1, evaluating its potential in combination with apalutamide in mCRPC patients with AR mutations. We have shown previously that degradation of GSPT1 dampens MYC signaling in CRPC, a pathway we believe is moving to center stage for new treatment options in CRPC. We look forward to a data update from this Phase 2 study in 2027, as well as a final data update from our completed Phase 1/2 study of MRT-2359 in combination with enzalutamide by year-end. Novartis’s advancement of MRT-6160 (DDY391) into Phase 2 studies in Sjögren’s disease and psoriatic arthritis expands the evaluation of VAV1 degradation across immune-mediated diseases and brings additional non-dilutive funding to Monte Rosa. With our balance sheet expected to support operations into 2029, we are well positioned to pursue these opportunities while maintaining a disciplined focus on generating clinical evidence and advancing our pipeline."

RECENT HIGHLIGHTS

MRT-8102, NEK7-directed MGD for inflammatory diseases driven by NEK7/NLRP3 and IL-1

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In October, Monte Rosa reported positive results from GFORCE-1 (NCT07119125), a Phase 1 study of MRT-8102 in 108 obese subjects with elevated cardiovascular disease risk. Across all three dose levels, MRT-8102 achieved median NEK7 degradation of approximately 80% to 90%. MRT-8102 also resulted in substantial reductions of IL-1β as well as HMGB1, calprotectin, S100A12, and SAA, damage-associated molecular patterns (DAMPs) linked to pathogenic biology within atherosclerotic plaques and vessel walls. MRT-8102 was well tolerated, with no serious adverse events, adverse event rates similar to placebo, and no evidence of increased infection risk.
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With dose selection informed by the GFORCE-1 data, Monte Rosa plans to initiate three Phase 2 studies of MRT-8102:
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GEMINI-1, a Phase 2 study in patients with gout, is expected to initiate in Q4 2026. The study will evaluate prevention of flare recurrence following management of acute flares, with initial data expected in H2 2027.
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GFORCE-2, a focused Phase 2b study in patients with stable coronary artery disease and residual inflammation, is expected to initiate in H1 2027. The study is expected to evaluate imaging-based coronary artery plaque assessment, such as fat attenuation index (FAI), along with NLRP3 genetics and molecular drivers of local disease pathogenesis and systemic inflammation, to inform the design of an innovative and efficient Phase 3 study focused on the most disease-modifiable patient population.
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GALAXY-1, a Phase 2 study in patients with moderate to severe hidradenitis suppurativa, is expected to initiate in H1 2027.
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Due to prioritization of the MRT-8102 Phase 2 study initiations, Investigational New Drug (IND) submission for the next-generation NEK7 MGD is now anticipated in 2027.

MRT-2359, GSPT1-directed MGD for mCRPC

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In August, Monte Rosa dosed the first patient in MODeFIRe-1 (NCT07745361), a Phase 2 study of MRT-2359 in combination with apalutamide in AR-mutant mCRPC patients who received prior treatment with a second-generation AR inhibitor. The study will enroll up to 25 patients, with MRT-2359 administered orally at 0.5 mg on a 21 days on, 7 days off schedule. Endpoints include PSA response, RECIST response, duration of response, radiographic progression-free survival, PSA progression-free survival, and safety. Monte Rosa has a clinical supply agreement with Johnson & Johnson to support the study.
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Enrollment in the initial Phase 1/2 study expansion arm, in patients with mCRPC, has been completed. A total of 6 patients with AR mutations were enrolled and treated with MRT-2359 in combination with enzalutamide. Monte Rosa plans to provide an update on this patient subset by the end of the year. Interim data were presented at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in February.

MRT-6160 (DDY391), VAV1-directed MGD for immune-mediated conditions

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In September, Monte Rosa announced achievement of a milestone associated with its collaborator Novartis initiating a global Phase 2a/b randomized, double-blind, placebo-controlled study (NCT07737743), evaluating the efficacy, safety, and tolerability of up to 52 weeks of treatment with MRT-6160 (DDY391) in participants with Sjögren’s disease. The first patient visit triggered a $50 million milestone payment to Monte Rosa.
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In October, Monte Rosa announced achievement of an additional milestone associated with Novartis initiating a second Phase 2 study of MRT-6160 (DDY391) in participants with active moderate to severe psoriatic arthritis (PsA). The Phase 2a/b randomized, double-blind, placebo-controlled, multicenter study (NCT07801495) will evaluate the efficacy, safety, tolerability, and dose-response relationship of MRT-6160 (DDY391). The first patient visit triggered a $37.5 million milestone payment to Monte Rosa.
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The Sjögren’s and PsA studies are the first two of several studies expected for MRT-6160 (DDY391). Under its global exclusive development and commercialization license agreement with Novartis, Monte Rosa is eligible for additional Phase 2 study initiation milestone payments.

CDK2 and Cyclin E1-directed MGD programs for solid tumors

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Monte Rosa expects to submit IND applications for its CDK2 and cyclin E1 (CCNE1)-directed MGD programs in 2027.

ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES

Immunology and inflammation programs

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Initiate GEMINI-1 Phase 2 study of MRT-8102 in gout in Q4 2026, with initial data expected in H2 2027.
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Initiate GFORCE-2 Phase 2b study of MRT-8102 in stable coronary artery disease in H1 2027.
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Initiate GALAXY-1 Phase 2 study of MRT-8102 in moderate to severe hidradenitis suppurativa in H1 2027.
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Monte Rosa expects its collaborator, Novartis, to initiate additional Phase 2 studies of MRT-6160 (DDY391) in immune-mediated diseases.

Oncology programs

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Provide a clinical data update on the initial Phase 1/2 expansion arm exploring MRT-2359 in combination with enzalutamide in mCRPC by the end of 2026.
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Provide a clinical data update on the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations in 2027.
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Submit an IND application for a CDK2-directed MGD in 2027.
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Submit an IND application for a CCNE1-directed MGD in 2027.

THIRD QUARTER 2026 FINANCIAL RESULTS

Collaboration Revenue: Collaboration revenue for the third quarter of 2026 was $54.4 million, compared to $12.8 million for the third quarter of 2025. The increase was primarily driven by recognition of collaboration revenue from the $50.0 million milestone triggered by the initiation of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with Sjögren’s disease. The $37.5 million milestone triggered by the initiation of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with psoriatic arthritis in October is not reflected in third quarter collaboration revenue as it was triggered after the end of the quarter. Collaboration revenue represents amounts earned from Monte Rosa’s collaboration and license agreements with Roche and Novartis.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2026 were $45.4 million, compared to $36.7 million for the third quarter of 2025. The increase was primarily driven by increased spending on development and discovery programs. R&D expenses included non-cash stock-based compensation of $3.3 million for the third quarter of 2026, compared to $2.5 million in the same period in 2025.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2026 were $10.9 million, compared to $9.1 million for the third quarter of 2025. G&A expenses included non-cash stock-based compensation of $3.0 million for the third quarter of 2026, compared to $1.9 million in the same period in 2025.

Net Income (Loss): Net income for the third quarter of 2026 was $3.1 million, compared to a net loss of $27.1 million for the third quarter of 2025.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2026, were $582.6 million, compared to $626.0 million as of June 30, 2026. The decrease of $43.4 million was primarily due to operational use of cash. In September, Monte Rosa announced achievement of a $50 million milestone associated with the first patient visit of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with Sjögren’s disease. In October, Monte Rosa announced achievement of a $37.5 million milestone associated with the first patient visit of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with active moderate to severe psoriatic arthritis. Cash receipts from these milestones are not reflected in the September 30th cash balance as the payments had not yet been received as of that date. Monte Rosa expects that its cash, cash equivalents, restricted cash, and marketable securities will support operations into 2029.

(Press release, Monte Rosa Therapeutics, NOV 5, 2026, View Source [SID1234674318])