On October 26, 2025 Novartis reported that it has entered into an agreement to acquire Avidity Biosciences, Inc. (Nasdaq: RNA), a San Diego-based, biopharmaceutical company focused on a new class of therapeutics enabling RNA delivery to muscle. The acquisition will follow the separation of Avidity’s early-stage precision cardiology programs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Avidity is committed to delivering a new class of pioneering RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs) for serious, genetic neuromuscular diseases. The proposed acquisition will bring Avidity’s late-stage neuroscience programs into Novartis and provide Novartis access to a differentiated RNA-targeting delivery platform. These programs are expected to advance the company’s neuroscience strategy and complement the current pipeline with potential first-in-class therapeutic candidates that address the genetic drivers of muscle-damaging conditions.

"Avidity’s pioneering AOC platform for RNA therapeutics ​and its late-stage assets bolster our commitment to delivering innovative, targeted and potentially first-in-class medicines to treat devastating, progressive neuromuscular diseases," said Vas Narasimhan, CEO of Novartis. "The Avidity team has built robust programs with industry-leading delivery of RNA therapeutics to muscle tissue. We look forward to developing these programs to meaningfully change the trajectory of diseases for patients."

The proposed acquisition raises the expected 2024-2029 sales CAGR for Novartis from +5% to +6% CAGR, representing a significant opportunity to deliver substantial shareholder returns over time.

Accelerating innovative RNA science and AOC therapies for patients with neuromuscular disease
The proposed acquisition aligns with the long-term neuroscience strategy of Novartis, expanding the company’s pipeline with potential near-term launches in genetically defined diseases with high unmet need. The Avidity programs feature potential first-in-class, late-stage disease-modifying therapies in myotonic dystrophy type 1 (DM1), a rare progressive neuromuscular disorder with a poor prognosis and no disease-modifying therapies; facioscapulohumeral muscular dystrophy (FSHD), a rare hereditary disorder causing relentless loss of muscle function and progressive disability; and Duchenne muscular dystrophy (DMD), a severe, early-onset disease marked by progressive muscle damage and reduced life expectancy.

The proposed acquisition is expected to create an industry-leading pipeline, building on the Novartis expertise in spinal muscular atrophy and commercialization capabilities in genetic neuromuscular diseases. Avidity aims to deliver meaningful patient benefits by addressing root genetic causes, restoring muscle function, and potentially slowing disease progression. Its AOC platform combines the tissue specificity of monoclonal antibodies with the precision of oligonucleotides, enabling targeted delivery to previously hard-to-reach muscle cells. AOCs carry disease-specific, oligonucleotide payloads intended to correct underlying genetic mechanisms and enable targeted, disease-modifying therapies with the potential to have significant impact on patient lives.

Transaction details
Under the terms of the transactions, which have been unanimously approved by the Boards of Directors of both companies, Novartis, through a merger with a newly formed indirect wholly owned subsidiary, will acquire all outstanding shares of Avidity. Pursuant to the terms of the merger agreement, holders of Avidity common stock will receive USD 72.00 per share in cash at closing, representing a premium of 46% to the closing share price on October 24, 2025, and valuing the company at approximately USD 12bn on a fully diluted basis and representing an enterprise value of approximately USD 11bn at the expected closing date.

Prior to the closing of the merger, Avidity will transfer to SpinCo, a wholly owned subsidiary of Avidity, the early-stage precision cardiology programs and collaborations of Avidity. The transfer includes certain Avidity assets whose transfer will trigger a right of first negotiation with an existing collaboration partner of Avidity. Holders of Avidity common stock will receive (1) a distribution of one share of SpinCo for every ten shares of Avidity they hold and/or (2) a pro rata cash distribution of the proceeds received by Avidity prior to the closing if certain SpinCo assets are, or SpinCo itself is, sold to a third party.

The acquisition by Novartis of Avidity is subject to the completion of a spin-off or a sale of SpinCo and other customary closing conditions, including the receipt of regulatory approvals and the approval of Avidity stockholders. The companies expect the merger to close in the first half of 2026. Until closing, Novartis and Avidity will continue to operate as separate and independent companies.

Novartis Investor Call
Novartis will host a conference call for investors to discuss the transaction on October 27, 2025 at 1 pm CET. Details can be found at View Source

(Press release, Novartis, OCT 26, 2025, View Source [SID1234657019])

On October 26, 2025 WuXi AppTec (stock code: 603259.SH / 2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life sciences industry, reported financial results for the first three quarters ending September 30, 2025 ("Reporting Period"):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For the first three quarters of 2025, total revenue reached RMB32.86 billion, up 18.6% year-over-year. Revenue from Continuing Operations reached RMB32.45 billion, up 22.5% year-over-year.
Adjusted non-IFRS gross profit reached RMB15.46 billion, with the adjusted non-IFRS gross profit margin up 6.1pts year-over-year to 47.0%.
Net profit attributable to the owners of the Company was RMB12.08 billion, up 84.8% year-over-year; diluted EPS was RMB4.21, up 87.9% year-over-year.
Adjusted non-IFRS net profit attributable to the owners of the Company was RMB10.54 billion, up 43.4% year-over-year; adjusted non-IFRS net profit margin up 5.6pts year-over-year to 32.1%; adjusted non-IFRS diluted EPS was RMB3.68, up 46.0% year-over-year.
With continuous capacity expansion to better meet customer demand, backlog for Continuing Operations reached RMB59.88 billion as of September 30, 2025, up 41.2% year-over-year.
Operating cash flow climbed 35.0% year-over-year to RMB10.87 billion, driven by business growth, increase in operating efficiency, and continued improvement of financial management capabilities.
Sustained and steady business growth as a result of our unique, fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) platform. Driven by "follow the molecule" and "win the molecule" strategies, WuXi Chemistry’s small molecule CRDMO pipeline continues to efficiently convert and capture high-quality molecules, delivering sustained business growth. In the first three quarters of 2025, a total of 621 new molecules were added to the small molecule Development and Manufacturing (D&M) pipeline. As of September 30, 2025, our small molecule D&M pipeline reached 3,430 molecules, representing an increase of 15 projects in phase III and commercial stages during the first three quarters of 2025.
Acceleration of global expansion, capacity construction and capability development. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA on-site inspections with no single observation. By the end of 2025, total reactor volume of small molecule APIs is expected to reach over 4,000kL. In September 2025, the construction of peptide capacity in Taixing was completed ahead of schedule; the Company’s total reactor volume of Solid Phase Peptide Synthesizers has been increased to more than 100,000L.
Robust shareholder returns. The Company remains committed to rewarding shareholders and actively supporting the Company’s value. This year, the Company has implemented a total of RMB6.88 billion in cash dividends, share repurchases and cancellations, representing more than 70% of the Company’s 2024 net profit attributable to the owners of the Company. Among these, the Company has distributed a total of RMB4.88 billion in cash dividends, including RMB2.83 billion for the 2024 annual cash dividend, RMB1.01 billion for the 2025 special cash dividend and RMB1.03 billion for the 2025 interim dividend. Meanwhile, the Company also completed the repurchase of RMB2.0 billion worth of A-shares in total, all of which have been cancelled.
[1] As disclosed in 2025 Third Quarterly Report, Continuing Operations include WuXi Chemistry, WuXi Testing, WuXi Biology and Others, the scope of which may change following adjustments to the Company’s business strategy.

[2] Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS).

[3] In 2024 Q1-Q3 and 2025 Q1-Q3, WuXi AppTec had a fully-diluted weighted average share count of 2,906,724,914 and 2,873,641,499 ordinary shares, respectively.

2025 Full-Year Outlook

With confidence in customers’ ongoing demand for enabling services, our CRDMO business model and management execution, the Company has further raised its full-year guidance.

The Company expects Continuing Operations revenue to resume double-digit growth in 2025, with its year-over-year growth rate raised to 17-18%, up from the prior 13-17%. As a result, the Company expects full-year total revenue of RMB43.5-44.0 billion, up from the prior RMB42.5-43.5 billion.

As it focuses on the core CRDMO business and continuously improved production and operating efficiency, the Company is confident and expects to further improve the adjusted non-IFRS net profit margin in 2025.

The Company is actively advancing global capacity construction; while due to longer-than-expected settlement cycles of certain projects, capex for 2025 is expected to reach RMB5.5-6.0 billion (adjusted from the prior RMB7.0-8.0 billion). Together with business growth, efficiency improvement, and considering the timing differences in project payments, free cash flow for 2025 is expected to increase from RMB5.0-6.0 billion to RMB8.0-8.5 billion.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "Reflecting robust customer demand and the strength of our unique CRDMO business model, WuXi AppTec delivered strong double-digit growth in revenue, profit and operating cash flow in the first three quarters of 2025, while our backlog for Continuing Operations reached a record RMB59.9 billion. Based on this momentum, we have further raised our full-year revenue and free cash flow guidance. The strategic divestment of clinical research services enables us to fully focus on our core CRDMO strategy and better meet the evolving needs of our customers. By concentrating on drug discovery, laboratory testing, process development, and manufacturing services, we are accelerating the growth of our global capabilities and capacities, delivering greater value for customers and shareholders, and advancing our vision that ‘every drug can be made and every disease can be treated’."

Business Performance by Segment

WuXi Chemistry: CRDMO Business Model Drives Continuous Growth; Q1-Q3 2025 Revenue Up 29.3 % YoY , with TIDES Revenue Up 121.1% YoY
Q1-Q3 revenue of WuXi Chemistry reached RMB25.98 billion, up 29.3% year-over-year. With continued optimization of production process and improvement in capacity efficiency driven by the growth of late-stage clinical and commercial projects, Q1-Q3 adjusted non-IFRS gross profit margin of WuXi Chemistry steadily improved 5.8pts year-over-year to 51.3%.
Small molecule drug discovery service ("R") continues to generate downstream opportunities. In the past 12 months, we successfully synthesized and delivered more than 430,000 new compounds to customers. In the meantime, 250 molecules were converted from R to D phase in the first three quarters of 2025. Through our "follow-the-customer" and "follow-the-molecule" strategies, we established trusted partnerships with our customers globally, supporting the sustainable growth of our CRDMO business.
Small molecule D&M service remains strong.
The small molecule CDMO pipeline continued to expand. Q1-Q3 revenue of small molecule D&M services rose 14.1% year-over-year to RMB14.24 billion. In the first three quarters of 2025, 621 new molecules were added to the small molecule D&M pipeline. As of September 30, 2025, our small molecule D&M pipeline reached 3,430 molecules, including 80 commercial projects, 87 in phase III, 374 in phase II and 2,889 in phase I and pre-clinical stages. This represents an increase of 15 projects in the commercial and phase III stages during the first three quarters of 2025.
We continued to build small molecule capacity. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA on-site inspections with no single observation. The total reactor volume of small molecule APIs is expected to reach over 4,000kL by the end of 2025.
TIDES business (oligo and peptides) sustains rapid growth.
With the ramp-up of new capacities released sequentially each quarter last year, Q1-Q3 TIDES revenue grew 121.1% year-over-year to RMB7.84 billion. As of September 30, 2025, TIDES backlog grew 17.1% year-over-year.
TIDES D&M customers grew 12% year-over-year, while the number of TIDES molecules grew 34% year-over-year.
In September 2025, the construction of peptide capacity in Taixing was completed ahead of schedule; the Company’s total reactor volume of Solid Phase Peptide Synthesizers has been increased to more than 100,000L.
WuXi Testing: Drug Safety Evaluation Service & Site Management Organization (SMO) Maintain Leading Positions
WuXi Testing revenue reached RMB4.17 billion in Q1-Q3, and Q1-Q3 adjusted non-IFRS gross profit margin was 26.5%.
With development of differentiated capabilities and enhanced operational management, Q3 revenue of lab testing services reached RMB1.08 billion, growing 7.2% year-over-year and 7.5% quarter-over-quarter; while its Q3 adjusted non-IFRS gross profit margin continued to improve quarter-over-quarter. Of which, the revenue of drug safety evaluation services grew 5.9% year-over-year and 13.2% quarter-over-quarter.
Q1-Q3 revenue of lab testing services grew 2.7% year-over-year to RMB2.96 billion. Due to market impact, its Q1-Q3 adjusted non-IFRS gross profit margin declined as pricing was gradually reflected in revenue along with backlog conversion. Of which, drug safety evaluation services revenue resumed positive year-over-year growth, while maintaining an industry-leading position in the Asia-Pacific region.
The Company is committed to actively enabling customers’ global licensing. New modality business continued to develop, while the Company maintained its leading position in areas including nucleic acids, conjugates, mRNA, multispecific antibodies and peptides.
The Company continued to advance automation. DMPK successfully launched its proprietary all-in-one compound identification software, enhancing efficiency in spectral interpretation and metabolite identification for nucleic acids and peptides by 83%.
The Suzhou facility has successfully passed 4 consecutive FDA on-site inspections.
Q1-Q3 revenue for clinical CRO & SMO was down 6.4% year-over-year to RMB1.21 billion due to market pricing impact; of which, SMO revenue was down 0.7% year-over-year as backlog gradually converted into revenue, while maintaining its industry leading position in China.
During the first three quarters of 2025, our clinical CRO business supported customers in obtaining 19 IND approvals and submitting for 2 NDA filings; the SMO business supported 75 new drug approvals for customers. The SMO business has supported 331 new drug approvals in total over the past decade, maintaining significant advantages in multiple areas (endocrinology, dermatology, lung cancer and cardiovascular disease, etc.).
WuXi Biology: Continues to Generate Downstream Opportunities; In Vitro & In Vivo Business Synergies and New Modality Business Drive Growth
WuXi Biology follows the science, continuously strengthens drug discovery capabilities in emerging areas and actively grows overseas businesses. It efficiently generates downstream opportunities for CRDMO model by continuously contributing more than 20% of the Company’s new customers.
Through cross-regional collaboration, comprehensive platform integration and integrated project transformation, we efficiently enable our customers worldwide. WuXi Biology revenue reached RMB1.95 billion in Q1-Q3 2025, a year-over-year increase of 6.6%.
Due to market pricing impact, Q1-Q3 adjusted non-IFRS gross profit margin of WuXi Biology was down 1.0pts to 37.0%. With continuously improved operational efficiency, its Q3 adjusted non-IFRS gross profit margin improved 1.5pts quarter-over-quarter.
We accelerated advancements in in vitro integrated screening technologies and continued to improve in vivo pharmacology capabilities, resulting in rapid year-over-year and quarter-over-quarter revenue growth. With its competitive edge continuously strengthened, the non-oncology business has achieved strong revenue growth, becoming an important contributor to business growth.
New modality drug discovery services continue to perform well, contributing more than 30% of WuXi Biology’s total revenue.
This release provides a summary of the results and does not intend to provide a complete statement relating to the Company, its securities, or any relevant matters herein that a recipient may need in order to evaluate the Company. For additional information, please refer to the WuXi AppTec 2025 Third Quarterly Results Presentation and 2025 Third Quarterly Report disclosed on the Company’s official website, as well as the Company’s disclosure documents and information on the Shanghai Stock Exchange, the Stock Exchange of Hong Kong Limited website. Investors are advised to exercise caution and be aware of the investment risks in trading Company shares.

Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS), in currency of RMB. Besides, all other financial information disclosed in this press release is prepared in accordance with the International Financial Reporting Standards Accounting Standards ("IFRSs"), in currency of RMB.

The 2025 Third Quarterly Report of the Company has not been audited.

Third Quarter 2025 Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted non-
IFRS Gross
Profit

Change

Adjusted
non-IFRS
Gross Profit
Margin

WuXi Chemistry

9,676.68

22.7 %

5,329.83

40.6 %

55.1 %

WuXi Testing

1,480.83

2.1 %

428.69

-10.0 %

28.9 %

WuXi Biology

695.67

5.9 %

264.49

1.8 %

38.0 %

Others

191.78

163.8 %

161.60

658.4 %

84.3 %

Discontinued Operations (Note 1)

12.47

-96.9 %

12.47

N/A

100.0 %

Total

12,057.43

15.3 %

6,197.08

38.4 %

51.4 %

First Three Quarters 2025 Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted non-
IFRS Gross
Profit

Change

Adjusted
non-IFRS
Gross
Profit
Margin

WuXi Chemistry

25,978.06

29.3 %

13,314.69

45.7 %

51.3 %

WuXi Testing

4,169.47

0.0 %

1,104.58

-26.1 %

26.5 %

WuXi Biology

1,947.27

6.6 %

720.38

3.8 %

37.0 %

Others

355.26

-10.5 %

258.90

24.1 %

72.9 %

Discontinued Operations (Note 1)

406.65

-66.5 %

56.49

N/A

13.9 %

Total

32,856.72

18.6 %

15,455.04

36.3 %

47.0 %

Note 1: In accordance with the IFRSs, the Company has classified the operations for which equity sale agreements were signed or sales were completed during the first three quarters of 2025 or the comparison year as discontinued operations.

Note 2: Any sum of the data above that is inconsistent with the total is due to rounding.

Consolidated Statement of Profit or Loss [4] – Prepared under IFRSs

RMB Million

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Revenue

12,057.4

10,461.1

32,856.7

27,702.0

Cost of sales

(6,050.8)

(6,063.8)

(17,737.9)

(16,603.8)

Gross profit

6,006.6

4,397.3

15,118.9

11,098.2

Other income

280.4

247.6

920.0

758.6

Other gains and losses

188.0

(602.5)

2,637.0

(394.1)

Impairment losses under expected credit losses

("ECL") model, net of reversal

(169.0)

(72.5)

(459.6)

(154.6)

Impairment losses of non-financial assets

(80.0)

–

(153.5)

–

Impairment losses of assets classified as held for sale

–

–

(120.7)

–

Selling and marketing expenses

(175.0)

(189.1)

(569.4)

(546.6)

Administrative expenses

(721.8)

(687.4)

(1,969.5)

(1,964.9)

R&D expenses

(311.2)

(317.7)

(825.7)

(954.0)

Operating Profit

5,018.1

2,775.7

14,577.4

7,842.5

Share of results of associates

199.9

87.1

440.1

202.9

Share of results of joint ventures

0.6

0.2

0.6

(4.0)

Finance costs

(88.8)

(58.2)

(257.6)

(187.2)

Profit before tax

5,129.7

2,804.7

14,760.5

7,854.3

Income tax expense

(1,583.8)

(484.0)

(2,830.9)

(1,252.7)

Profit for the period

3,545.8

2,320.8

11,929.6

6,601.6

Profit for the period attributable to:

Owners of the Company

3,514.6

2,293.1

11,801.9

6,532.9

Non-controlling interests

31.2

27.7

127.6

68.7

3,545.8

2,320.8

11,929.6

6,601.6

[4] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Profit or Loss[5] (continued) – Prepared under IFRSs

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Weighted average number of ordinary shares for calculating EPS

(expressed in shares)

– Basic

2,839,378,755

2,883,580,115

2,839,864,290

2,899,626,297

– Diluted

2,877,629,997

2,889,573,492

2,873,641,499

2,906,724,914

Earnings per share (expressed in RMB per S hare)

– Basic

1.24

0.80

4.16

2.25

– Diluted

1.22

0.79

4.12

2.24

[5] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Financial Position[6] – Prepared under IFRSs

RMB Million

September 3 0 ,

December 31,

2025

2024

Non-current Assets

Property, plant and equipment

25,662.5

25,267.8

Right-of-use assets

1,837.0

1,874.8

Goodwill

866.0

972.4

Other intangible assets

420.1

601.0

Interests in associates

1,939.2

2,322.2

Interests in joint ventures

3.9

3.4

Deferred tax assets

512.9

473.1

Financial assets at fair value through profit or
loss ("FVTPL")

8,350.8

8,943.4

Other non-current assets

115.7

114.7

Biological assets

1,085.7

1,063.0

Total Non-current Assets

40,793.8

41,635.7

Current Assets

Inventories

6,011.0

3,532.1

Contract costs

929.0

912.2

Biological assets

903.7

955.5

Amounts due from related parties

115.5

89.3

Trade and other receivables

10,731.6

9,643.7

Contract assets

819.0

988.8

Income tax recoverable

42.8

87.2

Financial assets at FVTPL

3,561.0

1,234.0

Derivative financial instruments

1.8

–

Other current assets

742.3

734.1

Pledged bank deposits

57.5

22.1

Term deposits with initial term of over three
months

3,921.4

4,865.6

Bank balances and cash

25,459.9

13,434.3

53,296.6

36,498.8

Assets classified as held for sale

515.7

2,191.3

Total Current Assets

53,812.3

38,690.2

Total Assets

94,606.1

80,325.8

[6] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Financial Position (continued)[7]– Prepared under IFRSs

RMB Million

September 3 0 ,

December 31,

2025

2024

Current Liabilities

Trade and other payables

7,746.5

7,025.5

Amounts due to related parties

7.9

15.3

Derivative financial instruments

2.9

202.0

Contract liabilities

2,565.7

2,251.0

Bank borrowings

5,282.1

1,278.6

Lease liabilities

179.9

224.2

Income tax payables

2,249.9

870.8

Convertible bonds

1,294.5

3,493.1

19,329.3

15,360.6

Liabilities directly associated with assets
classified as held for sale

109.0

865.5

Total Current Liabilities

19,438.3

16,226.1

Non-current Liabilities

Bank borrowings

1,799.1

2,959.5

Deferred tax liabilities

433.7

522.4

Deferred income

929.9

985.6

Lease liabilities

532.7

546.6

Total Non-current Liabilities

3,695.4

5,014.1

Total Liabilities

23,133.6

21,240.2

Net Assets

71,472.5

59,085.6

Capital and Reserves

Share capital

2,965.7

2,888.0

Reserves

67,982.4

55,744.7

Equity attributable to owners of the Company

70,948.1

58,632.7

Non-controlling interests

524.4

452.9

Total Equity

71,472.5

59,085.6

[7] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Adjusted Non-IFRS Net Profit Attributable to the Owners of the Company[8]

RMB Million

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Net p rofit attributable to the owners of the Company under CAS

3,514.6

2,293.1

12,075.5

6,532.9

GAAP difference[9]

–

–

(273.6)

–

Net p rofit attributable to the owners of the Company under IFRSs

3,514.6

2,293.1

11,801.9

6,532.9

Add:

Share-based compensation expenses

249.9

79.4

426.3

244.4

Issuance expenses of convertible bonds

8.7

–

28.4

–

Foreign exchange related losses

100.0

629.8

548.0

658.7

Amortization of acquired intangible assets from merger and
acquisition

6.7

13.3

20.5

40.3

Gains or losses from divestiture, restructuring and resource
integration initiatives

88.4

–

228.3

–

Non-IFRS net profit attributable to the owners of the Company

3,968.5

3,015.6

13,053.5

7,476.3

Add:

Realized and unrealized losses(gains) from venture capital
investments

254.4

(41.9)

(2,515.7)

(134.6)

Realized and unrealized share of (gains)losses from joint ventures

(0.6)

(0.2)

(0.6)

4.0

Adjusted non-IFRS net profit attributable to the owners of the
Company

4,222.3

2,973.5

10,537.1

7,345.7

(Press release, WuXi AppTec, OCT 26, 2025, View Source [SID1234657022])

On October 24, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported an update on the ongoing Phase 1 ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) study. The latest results show that, at the 100 mg APR-1051 dose level, 3 out of 4 patients achieved stable disease, as measured using RECIST v1.1 criteria.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A poster titled Early safety and efficacy of APR-1051, a novel WEE1 inhibitor, in patients with cancer-associated gene alterations: Updated data from ACESOT-1051 Phase 1 trial will be presented today at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The poster, to be presented by Drs. Timothy Yap MBBS, PhD, FRCP, University of Texas MD Anderson Cancer Center and lead investigator of the study, and Philippe Pultar, MD, Senior Medical Advisor at Aprea, summarizes preliminary results from the trial with a cutoff date of September 17, 2025. A copy of the poster will be available on Investors page of the Aprea corporate website under "Investor Presentations & Resources."

"We continue to be encouraged by these early clinical findings, which demonstrate signals of anti-tumor activity with APR-1051 in a heavily pre-treated patient population," said Dr. Pultar. "We believe the observation of disease control in tumors harboring FBXW7, CCNE1, and KRAS mutations align with our mechanistic understanding of WEE1 inhibition and reinforces the scientific rationale for APR-1051 development. We believe these promising data provide an important foundation as we continue with dose escalation in the ongoing study and we look forward to providing further updates as we advance to higher dose level in the ongoing study."

ACESOT-1051 Clinical Update (data cutoff October 19, 2025)

The primary objective of the trial is to characterize the safety profile, dose-limiting toxicity, maximum tolerated dose or maximum administered dose, and recommended Phase 2 dose of APR-1051. Secondary objectives are to 1) to characterize the pharmacokinetics of APR-1051 and the major metabolites and active metabolites of APR-1051, and 2) to assess preliminary efficacy of APR-1051
Results from Dose Level 6 (100 mg), show 3 out of 4 patients achieved stable disease, per RECIST v1.1 in heavily pretreated gastrointestinal and gynecologic malignancies
Disease stabilization was observed in patients with FBXW7, CCNE1, and KRASG12V + TP53 alterations
Favorable tolerability: No dose limiting toxicities (DLTs) or unexpected safety issues reported to date.
Following successful clearance of the 100 mg cohort, dose escalation has progressed to Dose Level 7 (150 mg)
For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.

Individual Patient Results

86-year-old female with rectal cancer: Treated at a 100 mg dose after five prior lines, the patient achieved stable disease (-13% reduction). Tumor harbored FBXW7 mutation which is a mechanistically relevant biomarker for WEE1 inhibition. 145 days on treatment and ongoing
55-year-old male with rectal cancer: Treated at a 100 mg dose after four prior lines, the patient achieved stable disease (+1%). Tumor harbored KRASG12V + TP53-mutant patient supports mechanistic activity in this genotype. 63 days on treatment and ongoing
73-year-old female with endometrial cancer: Treated at a 100mg after five prior lines, patient achieved stable disease by RECIST v1.1 criteria (+15%) at the first evaluation before voluntarily withdrawing consent after approximately two months of treatment. Tumor harbored CCNE1 and TP53 mutations supports mechanistic activity in this genotype.
50-year-old female with colon cancer: Treated at 100mg after two prior lines. This patient had disease progression at first assessment (8 weeks).

(Press release, Aprea, OCT 24, 2025, View Source [SID1234656973])

On October 24, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of differentiated targeted radiotherapies, reported new preclinical data for ATNM-400, its novel, first-in-class antibody radioconjugate armed with the potent alpha-emitter Actinium-225 (Ac-225) at the 32nd Annual Prostate Cancer Foundation (PCF) Scientific Retreat being held October 23 – 25, 2025 in Carlsbad, CA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ATNM-400, which targets a non-PSMA antigen associated with prostate cancer progression and treatment resistance, demonstrated superior tumor control and improved overall survival compared with the active agents in key standard-of-care therapies including enzalutamide (the active agent in Xtandi, Astellas/Pfizer) and 177Lu-PSMA-617 (the active agent in Pluvicto, Novartis), as well as 225Ac-PSMA-617 across multiple preclinical prostate cancer models.

These data further reinforce ATNM-400’s potential as a paradigm changing, PSMA-independent Ac-225 alpha radiotherapy, offering opportunities for use as a monotherapy, in combination regimens, and in patients relapsing after ARPI or PSMA-directed treatments. ATNM-400 data has now been presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper), Society for Nuclear Medicine and Molecular Imaging (SNMMI) and PCF annual conferences in 2025 demonstrating its growing potential in various treatment settings in prostate cancer. In addition, data highlighting its potential in non-small cell lung cancer will be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on Saturday, October 25, 2025.

Key Findings in Prostate Cancer Treatment Settings:

Potent and Durable Tumor Control, Increased Overall Survival and Synergistic Activity in Enzalutamide Resistant Prostate Cancer

Studies were performed in 22Rv1 prostate cancer models, which are known to be resistant to enzalutamide

ATNM-400 demonstrated superior and 5-times more durable anti-tumor efficacy extending to 100 days compared to approximately 20 days with enzalutamide alone

Given that ARPI therapies like enzalutamide are known to increase the ATNM-400 target antigen expression, combination treatment with ATNM-400 and enzalutamide was synergistic, resulting in complete tumor eradication in 40% of treated animals and significantly prolonged survival, whereas enzalutamide alone provided no durable disease control
Potent and Durable Tumor Control, Increased Overall Survival and Synergistic Activity in Enzalutamide Resistant Prostate Cancer

In models that progressed on enzalutamide, subsequent treatment with ATNM-400 achieved robust tumor control and extended survival, highlighting its potential in post-enzalutamide settings
Subsequent treatment with ATNM-400 achieved robust tumor control and extended survival, highlighting its potential in post-enzalutamide settings

Highly Effective and Increased Overall Survival in 177Lu-PSMA-617 Resistant Prostate Cancer

22Rv1 prostate cancer models are also resistant to 177Lu-PSMA-617

ATNM-400 overcame 177Lu-PSMA-617 resistance with approximately 5-times long tumor control and 2-times longer overall survival in tumor bearing animals
Highly Effective and Increased Overall Survival in 177Lu-PSMA-617 Resistant Prostate Cancer

Potent Therapeutic Activity Independent of PSMA Expression Levels

ATNM-400 targets a highly differentiated, non-PSMA antigen associated with the development and progression of prostate cancer, exhibiting potent therapeutic activity independent of PSMA expression levels

The expression of the ATNM-400 antigen target was not altered post-177Lu-PSMA-617
Potent Therapeutic Activity Independent of PSMA Expression Levels

22Rv1 cell lines are low-PSMA expressing and LNCaP cell lines are high-PSMA expressing
Addressing Critical Unmet Needs in mCRPC

Prostate cancer patients who progress to mCRPC face limited treatment options. While ARPI therapies like enzalutamide and PSMA-targeted radiotherapies like Pluvicto have extended survival, resistance and disease progression remain major challenges. In addition, a significant number of patients do not respond to PSMA-targeted radiotherapy as approximately 25%-30% of patients with mCRPC have low or no detectable PSMA and approximately 60% of patients have at least one PSMA-negative prostate cancer lesion.

By targeting a distinct, non-PSMA antigen associated with treatment resistance and poor outcomes, ATNM-400 represents a mechanistically differentiated alpha-radiotherapy approach that has potential in various treatment settings in prostate cancer. Its combination of a high-affinity antibody and potent alpha-emitting Ac-225 payload provides a path to overcome therapeutic resistance and extend patient survival beyond current standards of care.

Differentiation and Potential Clinical Impact

Sandesh Seth, Chairman and Chief Executive Officer, Actinium Pharmaceuticals, Inc., stated, "Since unveiling ATNM-400 earlier this year at AACR (Free AACR Whitepaper), our enthusiasm for this program only continues to grow commensurate with the promising results generated supporting its potential in various treatment settings in prostate cancer. ATNM-400 combines the precision of antibody targeting with the unparalleled potency of Ac-225 alpha particles, and importantly, it does so through a biologically distinct, PSMA-independent mechanism. These new preclinical data presented at PCF provide further validation for ATNM-400 and positions it as a candidate capable of transforming the treatment paradigm for patients with mCRPC. We are thrilled by the positive reactions to our ATNM-400 data and its differentiated non-PSMA approach."

Mr. Seth added, "As we have recently announced, beyond prostate cancer, we are also advancing ATNM-400 into non-small cell lung cancer (NSCLC), where it has shown the ability to overcome resistance to osimertinib (TAGRISSO, AstraZeneca) an EGFR-TKI therapy in preclinical models. Together, these data highlight Actinium’s innovate approach to R&D that leverages our radiochemistry expertise and strong translational biology capabilities to create first-in-class, multi-indication radiotherapeutics."

Actinium Pharmaceuticals envisions multiple clinical applications for ATNM-400 in prostate cancer, including:

Monotherapy in earlier disease settings prior to PSMA-directed radiotherapy.

Combination therapy with ARPI’s to enhance and prolong treatment responses.

Sequential therapy for patients relapsing after ARPI or PSMA-targeted radioligand treatments.
Summary of Preclinical Highlights of ATNM-400

Novel Mechanism: First-in-class Ac-225-based antibody radioconjugate against a non-PSMA target, overexpressed in advanced and resistant prostate cancer.

Superior Efficacy: Outperformed 177Lu-PSMA-617, Ac225-PSMA-617 and enzalutamide in direct head-to-head preclinical comparisons.

Durable Responses: A single 40 µCi/kg dose produced strong tumor inhibition; multi-dose regimens yielded long-term tumor control exceeding both enzalutamide and 177Lu-PSMA-617.

Overcomes Resistance: ATNM-400 maintained potent anti-tumor activity in models resistant to both enzalutamide and 177Lu-PSMA-617.

Combination Synergy: Synergized with enzalutamide, achieving complete tumor regressions in 40% of treated animals and markedly extending survival.

Favorable Biodistribution: Demonstrated selective and durable tumor uptake and rapid clearance from normal tissues, supporting a strong therapeutic index.
About ATNM-400

ATNM-400 is a highly innovative, first-in-class, and multi-indication Actinium-225 (Ac-225) targeted radiotherapy candidate in development for prostate cancer and non-small cell lung cancer (NSCLC). ATNM-400 is highly differentiated in prostate cancer as it targets a distinct non-PSMA antigen strongly implicated in prostate cancer progression and treatment resistance. Unlike 177Lu-PSMA-617, the active agent in Pluvicto and the majority of radiotherapies under development, which rely on PSMA targeting, ATNM-400 is designed to maintain efficacy in low-PSMA or PSMA-resistant disease, a major unmet clinical need. Ac-225 delivers high-linear-energy-transfer alpha particles that induce irreparable double-strand DNA breaks, offering superior potency over beta emitters like Lutetium-177 (177Lu), and has a shorter tissue path length that may reduce off-target toxicity. The receptor specifically targeted by ATNM-400 continues to be expressed at a high level even after androgen receptor inhibitor (ARPI) and ATNM-400 has shown to overcome resistance to the ARPI therapy enzalutamide and work synergistically in combination with enhanced tumor control including complete tumor regression. In NSCLC, ATNM-400 has shown to overcome resistance to osimertinib, an EGFR tyrosine kinase inhibitor (TKI) that is a standard of care therapy.

Prostate cancer is the most commonly diagnosed cancer in men, with ~1.5 million new cases globally and over 313,000 cases expected in the U.S. in 2025. While early-stage disease is typically managed with surgery, radiation, and ARPI therapy, up to 20% of cases progress to mCRPC – a lethal stage with limited treatment options. Targeted radiotherapy is a growing field in prostate cancer, dominated by PSMA-targeting agents like Pluvicto, which had sales of over $1.3 billion in 2024, yet many patients either lack PSMA expression or develop resistance to Pluvicto. In the U.S., 40,000 to 60,000 mCRPC patients annually progress after ARPI therapy that as a class generated sales of over $10.0 billion in 2024 including enzalutamide (Xtandi), which led the ARPI class with sales of over $5.9 billion in 2024, highlighting a significant unmet need. Lung cancer is the leading cause of cancer deaths and there are there are over 200,000 new cases expected in the U.S. in 2025. NSCLC accounts for approximately 85% of all lung cancer cases. The EGFR TKI Osimertinib (TAGRISSO, AstraZeneca) generated sales of $6.6 billion in 2024. Across prostate cancer and NSCLC, there are approximately 500,000 new cases in the U.S. alone.

(Press release, Actinium Pharmaceuticals, OCT 24, 2025, View Source [SID1234656990])

On October 24, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported preclinical data for ARV-806, a PROTAC KRAS G12D degrader, at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, Massachusetts. The ARV-806 data presented show a differentiated profile based on degradation potency, antiproliferative activity, and induction of cancer cell death. ARV-806 is designed to target both the ON and OFF forms of KRAS G12D, which is the most common mutation of the KRAS protein. ARV-806 has the potential to address high unmet need in solid tumors, such as pancreatic, colorectal and non-small cell lung cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These data suggest the potential of targeted protein degradation to overcome historical limitations in addressing undruggable KRAS mutations," said Angela Cacace, Ph.D., Chief Scientific Officer of Arvinas. "ARV-806’s ability to eliminate both ON and OFF forms of KRAS G12D, combined with its potency and durability shown in preclinical models, supports our confidence in its clinical potential to deliver meaningful benefit for patients with KRAS G12D-mutated cancers."

Key highlights from the presentation include:

In vitro, ARV-806 degraded KRAS G12D with picomolar potency across pancreatic, colorectal, and lung cancer cell lines but did not induce degradation of wild-type and other mutant RAS isoforms.
ARV-806 is differentiated from other KRAS G12D targeting agents in development and has potential to be a best-in-class therapy for KRAS G12D mutated cancers due to:
Catalytic activity, which allows it to overcome upregulation, a common mechanism of resistance to inhibitor treatment
Compared with clinical-stage KRAS G12D ON and OFF inhibitors and another clinical-stage G12D degrader, ARV-806 demonstrated:
>25-fold greater potency in reducing cancer cell proliferation,
>40-fold higher potency in degrading KRAS G12D protein (versus the comparable clinical-stage G12D degrader), and
>10-fold lower concentrations required to induce pro-apoptotic BIM expression.
Following a single intravenous dose in a colorectal tumor xenograft model, ARV-806 degraded >90% of KRAS G12D for seven days, with parallel suppression of c-MYC (a key driver of cancer cell proliferation) and induction of BIM (Bcl-2-interacting mediator of cell death, a pro-apoptotic factor) for ≥5 days.
ARV-806 demonstrated robust efficacy responses at low doses in tumor models including: ≥30% tumor volume reductions in pancreatic and colorectal cell line-derived xenograft (CDX) models and a patient-derived xenograft (PDX) model of lung cancer.

These data demonstrate sustained pharmacodynamic activity consistent with long-lasting target degradation, which we believe supports intermittent clinical dosing. Arvinas is currently evaluating ARV-806 in a Phase 1 clinical trial in patients with KRAS G12D–mutated advanced solid tumors (NCT07023731).

Also shown in the poster, orally bioavailable pan-KRAS degraders have been identified that potently degrade multiple variants of KRAS and spare other RAS isoforms. A tool pan-KRAS PROTAC demonstrated robust single-agent activity and superior combination efficacy with immune checkpoint blockade compared with a pan-RAS ON inhibitor (7 complete responses compared with 2 complete responses).

About ARV-806
ARV‑806 is a novel, investigational PROTAC degrader designed to selectively target and degrade mutant Kirsten rat sarcoma (KRAS) G12D which is the most common mutation of the KRAS protein. Therefore, ARV-806 has the potential to address high unmet need in solid tumors, such as pancreatic, colorectal and lung cancer. ARV‑806 is currently being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors harboring KRAS G12D mutations.

(Press release, Arvinas, OCT 24, 2025, View Source [SID1234656974])