NuCana Announces Grant of Composition-of-Matter Patent for NUC-7738 in China

On November 5, 2025 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported that the China National Intellectual Property Administration ("CNIPA") has granted an important patent covering the composition of matter for NUC-7738. This patent (ZL 202010794701.2) is expected to serve as a key component of the patent protection for NUC-7738, which currently consists of over 85 issued patents worldwide. The composition of matter patent covers the chemical structure of NUC-7738, NuCana’s novel anti-cancer agent currently being evaluated in a Phase 1/2 clinical study (NuTide:701) in combination with pembrolizumab for patients with PD-1 inhibitor refractory or resistant melanoma. Securing this patent represents an important milestone for NuCana, strengthening its long-term global intellectual property strategy, while supporting potential opportunities to address unmet needs for innovative cancer therapies in China.

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Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer said: "We welcome the CNIPA’s decision to grant this important new patent, which further strengthens the intellectual property protection of NUC-7738. The encouraging clinical data observed to date, together with the recent translational findings presented at ESMO (Free ESMO Whitepaper) 2025, continue to build confidence in the therapeutic potential of NUC-7738 in combination with PD-1 inhibition. As we aim to expand the NuTide:701 study with additional patients, we look forward to reinforcing the overall data package and progressing toward our goal of bringing meaningful new treatment options to patients with cancer."

(Press release, Nucana, NOV 5, 2025, https://ir.nucana.com/news-releases/news-release-details/nucana-announces-grant-composition-matter-patent-nuc-7738-china [SID1234659470])

Financial report for the period 1 January 2025 to 30 September 2025

On November 5, 2025 Novo Nordisk reported sales increased by 12% in Danish kroner and by 15% at CER in the first nine months of 2025; R&D pipeline progress continues

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•Operating profit increased by 5% in Danish kroner and 10% at constant exchange rates (CER) to DKK 95.9 billion, impacted by one-off restructuring costs of around DKK 9 billion related to the company-wide transformation with the aim of streamlining Novo Nordisk’s operations to reinvest for growth. Had Novo Nordisk not incurred such restructuring costs amounting to around DKK 9 billion, operating profit would have increased by 15% in Danish kroner and 21% at CER.
•Sales in US Operations increased by 12% in Danish kroner (15% at CER). Sales in the US were positively impacted by gross-to-net sales adjustments. Sales in International Operations increased by 13% in Danish kroner (16% at CER).

•Sales within Diabetes and Obesity care increased by 12% in Danish kroner to DKK 215.7 billion (15% at CER), mainly driven by Obesity care growth of 37% in Danish kroner to DKK 59.9 billion (41% at CER) and GLP-1 diabetes sales growing 7% in Danish kroner (10% at CER). Rare disease sales increased by 10% in Danish kroner (13% at CER).

•Within R&D, Novo Nordisk announced that the US FDA had approved an indication for Wegovy for the treatment of MASH. Further, Novo Nordisk agreed to acquire Akero Therapeutics, Inc. and its phase 3 FGF21 analogue in MASH and Omeros’ clinical-stage MASP-3 inhibitor zaltenibart within Rare blood disorders. Also within Rare disease, Novo Nordisk submitted Mim8 for regulatory approval in the EU and in the US. Finally, cagrilintide phase 3 development was initiated, with the potential to be the first amylin monotherapy treatment on the market for weight management.

•For the full-year 2025 outlook, sales growth is now expected to be 8-11% at CER with operating profit growth now expected to be 4-7% also at CER, including a negative full-year impact of around DKK 8 billion from the company-wide transformation. Sales and operating profit growth reported in Danish kroner is now expected to be 4 and 6 percentage points lower than at CER, respectively. The narrowing of the guidance ranges reflects lowered growth expectations for Novo Nordisk’s GLP-1 treatments within diabetes and obesity.

•In October, Novo Nordisk announced that the Board of Directors decided to convene an extraordinary general meeting, to be held on 14 November 2025 to elect new members of the Board of Directors of Novo Nordisk.
PROFIT AND LOSS 9M 2025 9M 2024 Growth
as reported Growth
at CER*
DKK million
Net sales 229,920 204,720 12 % 15 %
Operating profit 95,922 91,602 5 % 10 %
Net profit
75,543 72,758 4 % N/A
Diluted earnings per share (in DKK) 16.99 16.29 4 % N/A
* CER: Constant exchange rates (average 2024).

"Our company-wide transformation has already driven operational efficiencies, and we have a renewed focus that can deliver a range of potential treatment options that will serve millions more patients, mainly in obesity. While we delivered robust sales growth in the first nine months of 2025, the lower growth expectations for our GLP-1 treatments have led to a narrowing of our guidance. We agreed to acquire Akero Therapeutics Inc., adding a potential first-and-best-in-class asset within F4 in MASH, and initiated our phase 3 programme with cagrilintide for weight management. We aim to accelerate on all fronts to be able to compete better in dynamic and increasingly competitive markets," said Mike Doustdar, president and CEO.

On 5 November 2025 at 13.00 CET, corresponding to 07.00 am EST, an earnings call will be held. Investors will be able to listen in via a link on novonordisk.com, which can be found under ‘Investors’ (the contents of the company’s website do not form a part of this Form 6-K).
Novo Nordisk A/S
Investor Relations
Novo Alle 1
2880 Bagsværd
Denmark Telephone:
+45 4444 8888
www.novonordisk.com CVR Number:
24 25 67 90
Company announcement No 31 / 2025

Financial report for the period 1 January 2025 to 30 September 2025
Page 2 of 38

STRATEGIC ASPIRATIONS
STRATEGIC ASPIRATIONS 2025
The strategic aspirations are objectives that Novo Nordisk intends to work towards and are not a projection of Novo Nordisk’s financial outlook or expected growth. Novo Nordisk intends to describe how its activities develop in relation to each of the four dimensions on an ongoing basis.

Performance highlights for the first nine months of 2025 (blue indicates third-quarter development).

PERFORMANCE HIGHLIGHTS
Financials
Deliver solid sales and operating profit growth:
–Sales growth of 15% (CER)
–Operating profit growth of 10% (CER), impacted by one-off restructuring costs related to a company-wide transformation as well as impact related to the acquisition of the three former Catalent manufacturing sites
–Had Novo Nordisk not incurred such restructuring costs amounting to around DKK 9 billion, operating profit would have increased by 21% (CER)
Drive operational efficiencies:
–Operational leverage reflecting sales growth

Enable attractive capital allocation to shareholders:
–Free cash flow of DKK 63.9 billion
–DKK 53.2 billion returned to shareholders

e
Innovation and therapeutic focus
Further raise innovation bar for Diabetes treatment:
–Ozempic received positive opinion by CHMP for the treatment of peripheral arterial disease in the EU
–Rybelsus CV indication, based on SOUL, approved in the US and received positive CHMP opinion in the EU
–Resubmission of Awiqli in the US for treatment of type 2 diabetes
to
Develop superior treatment solutions for Obesity:
–Oral semaglutide 25 mg for weight management submitted in the US and in the EU
–In-license agreements of a triple agonist and two oral molecules
–Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development
–Semaglutide 7.2 mg submitted in the EU
–Wegovy approved in the US for MASH indication
–Phase 3 programme with cagrilintide initiated
–Initiation of phase 1b/2 programme with triple agonist
Strengthen and progress Rare disease pipeline:
–Sogroya non-replacement indications submitted in the US, Japan
–Alhemo (concizumab) approved in the US for the treatment of haemophilia A and B without inhibitors
–Mim8 submitted for regulatory approval in the EU and in the US
–Agreed to acquire clinical-stage MASP-3 inhibitor zaltenibart

Establish presence in Cardiovascular & Emerging Therapy Areas:
–Semaglutide 2.4 mg in MASH submitted for regulatory approval in Japan and in the EU
–Phase 2 trials with CDR123L in patients with chronic heart failure and preserved or reduced ejection fraction initiated
–Agreed to acquire Akero and its phase 3 FGF21 analogue in MASH
–Phase 3 trial with coramitug initiated in people living with ATTR cardiomyopathy.
Commercial execution
Strengthen diabetes leadership to more than one-third:
–Diabetes value market share declined by 2.3 percentage points to 31.6% (MAT)
More than DKK 25 billion* in Obesity care sales by 2025:
–Obesity care sales increased by 41% (CER) to DKK 59.9 billion

Secure a sustained growth outlook for Rare Disease:
–Rare disease sales increased by 13% (CER) to DKK 14.3 billion
e-t
Purpose and sustainability (ESG)
Progress towards zero environmental impact:
–Overall CO2e emissions (scope 1, 2 and full scope 3) increased by 21% compared to the first nine months of 2024

Adding value to society:
–Medical treatment provided to 42.4 million people living with diabetes and 3.2 million people living with obesity

* on a full-year basis.

Strategic aspirations Performance highlights Commercial execution Financials Cash flow and capital allocation Outlook Innovation and therapeutic focus Purpose and sustainability Corporate Governance Legal Financial Information
Company announcement No 31 / 2025

Financial report for the period 1 January 2025 to 30 September 2025
Page 3 of 38

PERFORMANCE HIGHLIGHTS
FINANCIAL HIGHLIGHTS FOR THE FIRST NINE MONTHS OF 2025
PROFIT AND LOSS 9M 2025 9M 2024 % change
9M 2025 to
9M 2024 % change
9M 2025 to
9M 2024 at CER¹
(Amounts are in DKK million, except for earnings per share)
Net sales
229,920 204,720 12 % 15 %
Gross profit 186,280 173,222 8 % 12 %
Gross margin 81.0% 84.6%
Sales and distribution costs (48,421) (43,400) 12 % 15 %
Percentage of sales 21.1% 21.2%
Research and development costs (37,391) (34,260) 9 % 10 %
Percentage of sales 16.3% 16.7%
Administrative costs (4,420) (3,696) 20 % 22 %
Percentage of sales 1.9% 1.8%
Other operating income and expenses (126) (264) N/A N/A
Operating profit (EBIT)
95,922 91,602 5 % 10 %
Operating margin 41.7% 44.7%
Financial items (net) 433 32 N/A N/A
Profit before income taxes 96,355 91,634 5 % N/A
Income taxes (20,812) (18,876) 10 % N/A
Effective tax rate 21.6% 20.6%
Net profit 75,543 72,758 4 % N/A
Net profit margin 32.9% 35.5%
OTHER KEY NUMBERS
Depreciation, amortisation and impairment losses 16,420 13,909 18 % N/A
Capital expenditure (PP&E) 41,711 31,063 34 % N/A
Net cash generated from operating activities 111,483 108,667 3 % N/A
Free cash flow1
63,887 71,760 (11 %) N/A
EBITDA1
112,342 105,511 6 % 11 %
Adjusted net profit1
87,748 80,042 10 % N/A
Total assets 512,288 397,441 29 % N/A
Equity 169,896 120,522 41 % N/A
Equity ratio 33.2% 30.3%
Diluted earnings per share / ADR (in DKK) 16.99 16.29 4 % N/A
Full-time equivalent employees end of period 78,554 71,880 9 % N/A
1) See appendix 7: Non-IFRS financial measures (additional information).

These unaudited consolidated financial statements for the first nine months of 2025 have been prepared in accordance
with IAS 34 ‘Interim Financial Reporting’ and additional Danish disclosure requirements for listed companies.
The accounting policies adopted in the preparation are consistent with those applied in the Annual Report 2024 of Novo
Nordisk.

Strategic aspirations Performance highlights Commercial execution Financials Cash flow and capital allocation Outlook Innovation and therapeutic focus Purpose and sustainability Corporate Governance Legal Financial Information
Company announcement No 31 / 2025

Financial report for the period 1 January 2025 to 30 September 2025
Page 4 of 38

COMMERCIAL EXECUTION
SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
Sales grew by 12% measured in Danish kroner and by 15% at CER in the first nine months of 2025, driven by Obesity care sales growth of 41% (CER), driven by Wegovy and Diabetes care sales growth of 8% (CER), driven by Ozempic. Rare disease sales increased by 13% (CER).

Sales split per therapy Sales 9M 2025
DKK million Sales 9M 2024
DKK million Growth
as reported Growth
at CER Share of growth
at CER
Diabetes and Obesity care segment
Injectable GLP-1 97,885 90,568 8 % 11 % 32 %
– Ozempic
95,264 86,489 10 % 13 % 36 %
– Victoza
2,621 4,079 (36 %) (34 %) (4 %)
Rybelsus
16,790 16,384 2 % 5 % 2 %
Total GLP-1 114,675 106,952 7 % 10 % 34 %
Long-acting insulin1
14,055 13,937 1 % 3 % 1 %
Premix insulin2
7,806 7,922 (1 %) 0 % 0 %
Fast-acting insulin3
13,703 12,505 10 % 12 % 5 %
Human insulin 4,172 5,122 (19 %) (15 %) (2 %)
Total insulin 39,736 39,486 1 % 3 % 4 %
Other Diabetes care4
1,348 1,608 (16 %) (14 %) (1 %)
Total Diabetes care 155,759 148,046 5 % 8 % 37 %
Wegovy
57,242 38,340 49 % 54 % 66 %
Saxenda
2,660 5,400 (51 %) (49 %) (8 %)
Total Obesity care 59,902 43,740 37 % 41 % 58 %
Diabetes and Obesity care total 215,661 191,786 12 % 15 % 95 %
Rare disease segment
Rare blood disorders5
8,936 8,740 2 % 5 % 1 %
Rare endocrine disorders6
4,125 3,070 34 % 37 % 4 %
Other Rare disease7
1,198 1,124 7 % 9 % 0 %
Rare disease total 14,259 12,934 10 % 13 % 5 %
Total sales 229,920 204,720 12 % 15 % 100 %
1) Comprises Tresiba, Xultophy, Levemir and Awiqli.
2) Comprises Ryzodeg and NovoMix.
3) Comprises Fiasp and NovoRapid.
4) Primarily NovoNorm, needles and GlucaGen HypoKit.
5) Comprises NovoSeven, NovoEight, Esperoct, Refixia, NovoThirteen and Alhemo.
6) Primarily Norditropin and Sogroya.
7) Primarily Vagifem and Activelle.

Strategic aspirations Performance highlights Commercial execution Financials Cash flow and capital allocation Outlook Innovation and therapeutic focus Purpose and sustainability Corporate Governance Legal Financial Information
Company announcement No 31 / 2025

Financial report for the period 1 January 2025 to 30 September 2025
Page 5 of 38

DIABETES AND OBESITY CARE
Diabetes care, sales and market share development
Sales in Diabetes care increased by 5% measured in Danish kroner and by 8% at CER to DKK 155,759 million, mainly driven by growth of GLP-1-based products. Novo Nordisk has a strategic aspiration of strengthening the Diabetes care leadership, aiming at reaching a global value market share of more than one-third in 2025. Novo Nordisk’s global diabetes value market share decreased by 2.3% percentage points over the last 12 months to 31.6%. In IO countries, tirzepatide is categorised under GLP-1 diabetes only in IQVIA data, despite having indications for Diabetes and Obesity in most launched countries. Novo Nordisk is the market leader and has a total GLP-1 volume market share, across Diabetes and Obesity care, of 59.0% globally. Within the US Operations and IO Operations, Novo Nordisk has a total GLP-1 volume market share of 47.3% and 68.4%, respectively.

In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from August 2024 and August 2025 provided by the independent data provider IQVIA. EUCAN covers Europe and Canada, Emerging Markets covers mainly Latin America, the Middle East and Africa. APAC covers Japan, Korea, Oceania, and Southeast Asia. Region China covers Mainland China, Hong Kong and Taiwan.
Diabetes care, development per geographical area Novo Nordisk’s share of the total diabetes market (value, MAT) Diabetes care, sales development
August August Sales 9M 2025
DKK million Growth
at CER
2025 2024
Global 31.6 % 33.8 % 155,759 8 %
US Operations 32.7 % 34.8 % 84,595 11 %
International Operations 28.2 % 30.7 % 71,164 4 %
– EUCAN * 32.3 % 35.3 % 32,376 8 %
– Emerging Markets ** 25.2 % 29.0 % 15,982 0 %
– APAC *** 17.3 % 18.7 % 9,496 6 %
– Region China **** 32.4 % 33.1 % 13,310 0 %

Source: IQVIA, August 2025 data. *Data for EUCAN available for 26 European markets and Canada representing approximately 100% of Novo Nordisk’s Diabetes care in the area. **Data for Emerging Markets available for 13 markets representing approximately 78% of Novo Nordisk’s Diabetes care in the area. ***Data for APAC available for five markets representing approximately 78% of Novo Nordisk’s Diabetes care in the area ****Data for mainland China, excluding Hong Kong and Taiwan. In IO countries, tirzepatide is categorised under GLP-1 diabetes only, despite having indications for diabetes and obesity in most launched countries.

GLP-1-based therapies for type 2 diabetes
Sales of GLP-1-based products for type 2 diabetes (Rybelsus, Ozempic and Victoza) increased by 7% measured in Danish kroner and by 10% at CER to DKK 114,675 million. The estimated global GLP-1 share of total diabetes prescriptions increased to 7.4% compared with 6.5% 12 months ago. It is possible for a patient to have a prescription for more than one diabetes treatment. Novo Nordisk has a value market share of 49.3%.
GLP-1 diabetes, development per geographical area Novo Nordisk’s share of the diabetes GLP-1 market (value, MAT) GLP-1 diabetes, sales development
August August Sales 9M 2025
DKK million Growth
at CER
2025 2024
Global 49.3 % 55.7 % 114,675 10 %
US Operations 48.1 % 53.3 % 73,252 10 %
International Operations 56.3 % 71.6 % 41,423 10 %
– EUCAN * 58.4 % 72.9 % 22,523 15 %
– Emerging Markets ** 47.7 % 64.2 % 8,333 6 %
– APAC *** 46.4 % 72.8 % 5,243 12 %
– Region China **** 82.2 % 79.9 % 5,324 (4 %)

Source: IQVIA, August 2025 data. Data for EUCAN available for 26 European markets and Canada representing approximately 100% of Novo Nordisk’s Diabetes care in the area. **Data for Emerging Markets available for 13 markets representing approximately 78% of Novo Nordisk’s Diabetes care in the area. ***Data for APAC available for five markets representing approximately 78% of Novo Nordisk’s Diabetes care in the area ****Data for mainland China, excluding Hong Kong and Taiwan. Note: the estimated GLP-1 share of prescriptions is based on volume packs from IQVIA. Volume packs are converted into full-year patients/prescriptions based on WHO assumptions for average daily doses, or if not available, Novo Nordisk assumptions. In IO countries, tirzepatide is categorised under GLP-1 diabetes only, despite having indications for diabetes and obesity in most launched countries.

Strategic aspirations Performance highlights Commercial execution Financials Cash flow and capital allocation Outlook Innovation and therapeutic focus Purpose and sustainability Corporate Governance Legal Financial Information
Company announcement No 31 / 2025

Financial report for the period 1 January 2025 to 30 September 2025
Page 6 of 38

Ozempic sales increased by 10% measured in Danish kroner and by 13% at CER to DKK 95,264 million. Sales growth was driven by both US Operations and International Operations. US sales were positively impacted by gross-to-net sales adjustments.

Rybelsus sales increased by 2% measured in Danish kroner and by 5% at CER to DKK 16,790 million. Sales growth was driven by International Operations, mainly within EUCAN, APAC and China, offset by decreasing sales in US Operations.

Victoza sales decreased by 36% measured in Danish kroner and by 34% at CER to DKK 2,621 million. The decline was driven by the GLP-1 diabetes market moving towards once-weekly treatments in both US Operations and International Operations.

US Operations
Sales of GLP-1 Diabetes care products in US Operations increased by 7% measured in Danish kroner and by 10% at CER. The sales increase was driven by Ozempic, partially countered by Victoza and Rybelsus. Ozempic sales in the US were positively impacted by gross-to-net sales adjustments followed by increasing volume growth, partially countered by lower realised prices. Novo Nordisk has a 48.1% value market share. The estimated GLP-1 share of total diabetes prescriptions has increased to 19.6% compared with 17.2% 12 months ago.

Sales growth in US Operations was positively impacted by gross-to-net sales adjustments, mainly related to Ozempic. Further, sales growth was driven by a prescription volume growth of the GLP-1 diabetes class of more than 10% in the third quarter of 2025 compared with the third quarter of 2024, countered by a decline in market share. Novo Nordisk’s share of total monthly prescriptions was 45.1%, while the share of new-to-brand prescriptions has decreased to 38.8%.

International Operations
Sales of GLP-1 Diabetes care products in International Operations increased by 7% measured in Danish kroner and by 10% at CER. The estimated GLP-1 share of total diabetes prescriptions has increased to 5.2% compared with 4.4% 12 months ago. Novo Nordisk is the market leader with a value market share of 56.3% compared with 71.6% 12 months ago.

EUCAN
Sales of GLP-1 Diabetes care products in EUCAN increased by 14% measured in Danish kroner and by 15% at CER. The sales growth reflects the uptake of Ozempic and Rybelsus. The estimated GLP-1 share of total diabetes prescriptions has increased to 10.0% compared with 8.4% 12 months ago. Novo Nordisk is the market leader in EUCAN with a value market share of 58.4%.

Emerging Markets
Sales of GLP-1 Diabetes care products in Emerging Markets decreased by 1% measured in Danish kroner and increased by 6% at CER. The estimated GLP-1 share of total diabetes prescriptions has increased to 3.1% compared with 2.5% 12 months ago. Novo Nordisk is the market leader in Emerging Markets with a value market share of 47.7%.

APAC
Sales of GLP-1 Diabetes care products in APAC increased by 10% measured in Danish kroner and by 12% at CER. The sales growth reflects increased sales of Rybelsus and Ozempic, partially offset by lower sales of Victoza. The estimated GLP-1 share of total diabetes prescriptions has increased to 3.1% compared with 2.4% 12 months ago. Novo Nordisk has a value market share of 46.4%.

Region China
Sales of GLP-1 Diabetes care products in Region China decreased by 7% measured in Danish kroner and by 4% at CER. The sales decline is driven by lower sales of Ozempic as well as Victoza. Ozempic is negatively impacted by wholesaler inventory movements. The GLP-1 share of total diabetes prescriptions has decreased to 3.1% compared with 3.4% 12 months ago. Novo Nordisk is the market leader in Region China with a value market share of 82.2%.

(Press release, Novo Nordisk, NOV 5, 2025, View Source [SID1234659469])

Nona Biosciences Announces Expansion of Collaboration with Umoja Biopharma to Advance In Vivo CAR-T Cell Therapies

On November 5, 2025 Nona Biosciences, a global biotechnology company providing integrated solutions from "Idea to IND" (I to ITM), reported an evaluation and license agreement with Umoja Biopharma ("Umoja"), the clinical-stage leader of in vivo cell therapies that aim to realize the full reach and promise of CAR-T cells.

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This agreement represents an expansion of the strategic collaboration established between the two companies in September 2024. The expanded partnership aims to create multiple in vivo CAR-T cell products by combining Nona’s proprietary HCAb Harbour Mice and NonaCarFxTM platforms with Umoja’s VivoVec platform.

Under the terms of the agreement, Nona Biosciences is eligible to receive an upfront payment, potential option exercise fees and milestone payments tied to the discovery and development of specific programs in the collaboration. Umoja will be responsible for all further product development and commercialization.

Dr. Di Hong, Chief Executive Officer of Nona Biosciences, commented, "We’re excited to expand our partnership with Umoja, a pioneer in in vivo CAR-T cell therapy. This collaboration reflects Umoja’s continued confidence in Nona’s technology platforms and expertise. With our industry-leading antibody discovery capabilities and deep experience in immunology and oncology, we look forward to supporting Umoja in developing next-generation in vivo CAR-T cell therapies with the potential to transform patient care."

"Expanding our collaboration with Nona Biosciences marks a critical next step in Umoja continuing to build an industry-leading, wholly-owned pipeline of in vivo CAR-T cell therapies," said Ryan Larson, PhD, Senior Vice President of Research, Umoja Biopharma. "This expanded partnership between Umoja and Nona enables us to harness Nona’s proprietary targeting technologies together with our VivoVecTM platform to accelerate the development of therapies that can transform the cell therapy landscape. By combining our expertise, we aim to enhance patient access to more innovative and effective medicines."

(Press release, Nona Biosciences, NOV 5, 2025, View Source [SID1234659468])

NextCure Provides Business Update and
Reports Third Quarter 2025 Financial Results

On November 5, 2025 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, reported a business update and announced third quarter 2025 financial results.

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"We have made significant progress advancing our promising ADC programs," said Michael Richman, NextCure’s president and CEO. "We recently began U.S. enrollment in the Phase 1 trial for SIM0505, our CDH6 ADC, initiating at a mid-tier dose range where multiple clinical responses were observed in China by our partner Simcere Zaiming. We expect to advance into higher-dose cohorts in the US shortly, as is currently occurring in China. We believe the ability to dose at levels that match or exceed competitor CDH6-targeting ADCs should demonstrate the promise of this program. We also received FDA clearance for our LNCB74 protocol amendment, giving us the ability to add higher dose escalation cohorts. We plan to provide proof of concept data readouts on SIM0505 and LNCB74 in the first half of 2026."

Business Highlights and Near-Term Milestones

SIM0505 (CDH6 ADC)

● A novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window.
● Acquired global rights in June 2025, excluding greater China where Simcere Zaiming retained rights.
● First U.S. patient dosed in October 2025 at a mid-tier dose level where multiple responses have been observed along with good tolerability in the ongoing Chinese trial.
● Proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026.

LNCB74 (B7-H4 ADC)

● A novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload.
● Co-developed with LigaChem Biosciences Inc. in a 50-50 cost share arrangement.
● Received Food and Drug Administration (FDA) acceptance of a protocol amendment giving us the ability to add higher dose escalation cohorts.
● Proof of concept data readout in the first half of 2026.

Financial Results for Quarter Ended September 30, 2025

● Cash, cash equivalents, and marketable securities as of September 30, 2025 were $29.1 million as compared to $68.6 million as of December 31, 2024. The decrease of $39.5 million was primarily due to cash used to fund operations, including the $12.0 million upfront license fee to Simcere Zaiming. We expect current financial resources to be sufficient to fund operating expenses and capital expenditures into mid-2026.
● Research and development expenses were $6.1 million for the three months ended September 30, 2025, as compared to $8.8 million for the three months ended September 30, 2024. The decrease of $2.6 million was due to lower costs related to deprioritized programs, lower preclinical development costs and lower personnel-related costs.
● General and administrative expenses were $2.8 million for the three months ended September 30, 2025, as compared to $3.7 million for the three months ended September 30, 2024. The decrease of $0.9 million was primarily related to lower personnel costs.
● Net loss was $8.6 million for the three months ended September 30, 2025, as compared to a net loss of $11.5 million for the three months ended September 30, 2024 due to the lower research and development costs and lower general and administrative costs as described above, partially offset by lower other income.

(Press release, NextCure, NOV 5, 2025, View Source [SID1234659467])

MaaT Pharma Presents Updated Preclinical Data at SITC Annual Meeting Demonstrating Immune Activation and Anti-Tumor Activity of MaaT034

On November 5, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported the presentation of updated preclinical data for MaaT034, its next generation drug candidate to be evaluated to improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors at the 40th Society for Immunotherapy Cancer Annual Meeting in National Harbor, MD held from November 5 to 9, 2025. The SITC (Free SITC Whitepaper) Annual Meeting is one of the world’s leading scientific and medical conferences focused on cancer immunotherapy. The dataset demonstrates compelling anti-tumor efficacy results and immune activation in germ-free mouse models. New analyses of multi-omic data from these models amplify the results previously presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2025.

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MaaT034, the first-in-class co-cultured full ecosystem product, is designed to optimize intestinal microbiome functions and improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors (ICIs). MaaT034 is part of the Company’s MET-C platform, which leverages AI-driven co-culture technology to create donor-independent synthetic microbiome ecosystems at industrial scale, targeting specific disease indications.

To guide further development of MaaT034 in immuno-oncology, and in addition to its preclinical program, MaaT Pharma is also participating in two exploratory, investigator-sponsored clinical trials evaluating its donor-derived drug candidates (MaaT013 and MaaT033), respectively in metastatic melanoma and in non-small cell lung cancer (NSCLC).

Key findings from the presentation at SITC (Free SITC Whitepaper) include:

Metagenomic analysis shows that MaaT034 successfully engrafts in the gut of germ-free mice and reproduces the microbial functions of native-based microbiome ecosystems.
MaaT034 improves dendritic cell (DC)-mediated T cell activation and potentiates anti-tumor effects mediated by anti-PD-1 checkpoint blockade in vitro.
70% of MaaT034 microbial species engraft in mice, ensuring an enduring presence of beneficial bacteria in the gut environment.In human FMT studies, the level of engraftment is significantly associated with positive clinical outcomes across multiple indications, as shown by a recent comprehensive meta-analysis[1].
MaaT034 increases the production of key microbial-derived metabolites such as short-chain fatty acids, secondary bile acids, and tryptophan metabolites in germ-free mice. This translates into an improved gastrointestinal physiology as evidenced by gut mucosal restoration.
MaaT034 optimizes anti-PD1 mediated activity in tumor-bearing, germ-free mice. While anti-PD1 alone reduced tumor growth by 10%, the combination of anti-PD1 and MaaT034 resulted in a 83.7% tumor growth reduction (compared to a 24.2% reduction when using a single strain of Akkermansia muciniphila[2] bacteria). These results demonstrate that improved tumor control is achieved with anti-PD1 in combination with MaaT034, as compared to PD-1 alone or in combination with a reference single bacterial strain.
"With MaaT034, we are entering a new phase in our drug platform development, one that leverages our deep experience in the development of complex microbiome therapies and cutting-edge computational analysis to build a next-generation drug candidate capable of enhancing patient response to immunotherapy," said Sheri Simmons, PhD, Acting Chief Scientific Officer, MaaT Pharma. "These findings strongly support advancing our donor-independent, synthetic microbiome therapy and we look forward to bringing MaaT034 into clinical development."

Details of poster presentation:

Abstract number: 1150
Title: MaaT034, a new co-cultured microbiome ecosystem therapy candidate, potentiates anti-PD1 mediated antitumoral activity in germ-free mice
Presentation Day: Saturday, Nov. 8, 2025
Primary Category: Microbiome and Other Environmental Factors
Upcoming investor and medical conferences participation

November 19-21, 2025 – Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) annual meeting in Geneva, Switzerland
November 25, 2025 – Investir Day event in Paris, France
December 6-9, 2025 – 67th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, Fl, USA
[1] Ianiro, G., Punčochář, M., Karcher, N. et al. Variability of strain engraftment and predictability of microbiome composition after fecal microbiota transplantation across different diseases. Nat Med 28, 1913–1923 (2022). View Source
[2] Akkermansia muciniphila is a commensal bacterium naturally present in large quantities in the gut microbiota of healthy people.

About MaaT034

MaaT034, currently in preclinical development, is a next-generation donor-independent full ecosystem synthetic microbiome therapy, dedicated to improving patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors. Developed using the Company’s co-culturing proprietary MET-C platform, MaaT034 is optimized for large-scale production in oncology. Previous presented preclinical data showed that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the role of MaaT034 in gut barrier repair and in T cell reactivation either in combination with anti-PD1 or with anti-PD-L1. By enhancing gut barrier repair and modulating immune responses, MaaT034 is expected to complement the action of these immunotherapeutic agents, potentially improving their efficacy in treating solid tumors cancer.

(Press release, MaaT Pharma, NOV 5, 2025, View Source [SID1234659466])