On July 28, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported positive data in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX (the "DURIPANC" study) (See: ClinicalTrials.gov NCT05927142) (Press release, AIM ImmunoTech, JUL 28, 2025, View Source [SID1234654567]).

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The DURIPANC study – which is a joint collaboration with AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands – is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. A total of 14 subjects have been enrolled in DURIPANC as of the mid-year report. The primary objective of the study is the clinical benefit rate of the combination therapy; the secondary/exploratory objectives include assessing overall survival (OS), progression-free survival (PFS) and initiating immune-monitoring using available tissue biopsies and peripheral immune profiling.

Prof. Casper van Eijck, MD, PhD, of Erasmus MC, stated: "Our preliminary data suggests that the combination of Ampligen and durvalumab is well-tolerated in post-FOLFIRINOX pancreatic cancer patients, with encouraging preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. Immunologic correlatives and further follow-up are essential to determine the biological activity and the durability of response. In addition, it will be important to identify which patients are most likely to benefit from the combination treatment, thereby personalizing therapy better and maximizing clinical outcomes."

See: DURIPANC, Mid-Year Interim Clinical Progress Update.

Pancreatic cancer has limited immunotherapy responsiveness, particularly in unselected populations. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Compared to these data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS:

No significant toxicity, an encouraging safety profile for a post-chemo setting;
~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and
OS >6 months in the majority (64%) of eligible patients-better than expected in this setting.
AIM ImmunoTech CEO Thomas K. Equels stated: "Data from Ampligen as a maintenance monotherapy was extremely positive when compared to existing therapeutic approaches. DURIPANC builds on that foundation and these results suggest a clear path forward and identify a promising potential benefit of combining the selective innate immune activation of Ampligen with the checkpoint inhibition of durvalumab in pancreatic cancer maintenance therapy. I am hopeful that pending immune-monitoring data analysis by Prof. van Eijck and the team at Erasmus Medical Center will identify additional mechanistic insights or predictive biomarkers in this potentially groundbreaking clinical trial, bringing hope for a future therapy for this highly lethal and clearly unmet medical need that kills more than 100,000 people in the American and European Union markets each year, and more than 500,000 worldwide."

AIM’S Pancreatic Cancer Profile

The DURIPANC study is the culmination of several years of focus by AIM on the development of Ampligen for the treatment of pancreatic cancer. Since 2017, more than 50 pancreatic cancer patients received treatment with Ampligen as an immuno-oncology mono-therapy under a Dutch government-approved Compassionate Use/Early Access Program at Erasmus MC. Prof. van Eijck was the lead investigator and the EAP has produced a number of detailed analyses in both abstracts and peer-reviewed medical research publications:

Rintatolimod (Ampligen) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program
Treating Pancreatic Ductal Adenocarcinoma Patients with Rintatolimod: Hitting Two Targets with One Arrow?
Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell-Mediated T-Cell Responses
Based on these strong results suggesting Ampligen’s potential effectiveness as a pancreatic cancer monotherapy, in January 2023 the Company entered into Clinical Agreements with AstraZeneca and Erasmus MC for the investigator-initiated DURIPANC clinical trial to study the potential combination therapy of Ampligen and Durvalumab, a PD-L1 checkpoint inhibitor.

In order to protect what has the potential to be a valuable long-term benefit for stockholders, AIM has developed an intellectual property plan specific to pancreatic cancer that includes a recently issued U.S. patent for Ampligen as an oncology treatment in combination with an anti-PD-L1, extending protection to August 9, 2039, as well as orphan drug designations in pancreatic cancer in both the United States and the European Union granting years of market exclusivity to AIM for Ampligen post-commercial approval.

On July 28, 2025 WuXi AppTec (stock code: 603259.SH / 2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical and life sciences industry, reported financial results for the first half ending June 30, 2025 ("Reporting Period") (Press release, WuXi AppTec, JUL 28, 2025, View Source;h1-revenue-from-continuing-operations1-up-24-2-yoy-and-adjusted-non-ifrs-net-profit-up-44-4-yoy-backlog-for-continuing-operations-up-37-2-yoy-302514805.html [SID1234654584]):

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For the first half of 2025, total revenue reached RMB20.80 billion, up 20.6% year-over-year. Revenue from Continuing Operations reached RMB20.41 billion, up 24.2% year-over-year.
Adjusted non-IFRS gross profit reached RMB9.26 billion, with the adjusted non-IFRS gross profit margin up 4.7pts year-over-year to 44.5%.
Net profit attributable to the owners of the Company was RMB8.56 billion, up 101.9% year-over-year; diluted EPS was RMB2.99, up 106.2% year-over-year.
Adjusted non-IFRS net profit attributable to the owners of the Company was RMB6.31 billion, up 44.4% year-over-year; adjusted non-IFRS net profit margin up 5.0pts year-over-year to 30.4%; adjusted non-IFRS diluted EPS was RMB2.20, up 46.7% year-over-year.
With continuous capacity expansion to better meet customer demand, backlog for Continuing Operations reached RMB56.69 billion as of June 30, 2025, up 37.2% year-over-year.
Operating cash flow climbed 49.1% year-over-year to RMB7.07 billion, driven by business growth, increase in operating efficiency, and continued improvement of financial management capabilities.
The Company’s sustained and steady business growth is the 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 half of 2025, a total of 412 new molecules have been added to the small molecule Development and Manufacturing (D&M) pipeline. As of June 30, 2025, our small molecule D&M pipeline reached 3,409 molecules, representing an increase of 8 projects in phase III and commercial stages during the first half of 2025.
The Company has been accelerating global expansion and capacity construction. 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, and the total reactor volume of Solid Phase Peptide Synthesizers is expected to increase to more than 100,000L.
As an enabler of innovation and a trusted partner and contributor to the global pharmaceutical and life sciences industry, the Company actively advanced sustainability and has been extensively recognized by global rating agencies. The Company has achieved the highest "AAA" rating from MSCI for the first time, becoming the first A-share listed company in the life sciences industry to achieve this milestone. In addition, the Company’s near-term emissions reduction targets have been validated by Science Based Targets initiatives (SBTi). Our accomplishments have also been acknowledged by major global rating agencies, including EcoVadis, CDP, United Nations Global Compact (UNGC), Sustainalytics and FTSE Russell.
The Company remains committed to rewarding shareholders and actively supporting the Company’s value. In the first half of 2025, the Company distributed a total of RMB3.84 billion in cash dividends, including RMB2.83 billion for the 2024 annual cash dividend and RMB1.01 billion for the 2025 special cash dividend. Meanwhile, the Company also completed the repurchase and cancellation of RMB1.0 billion worth of A-shares in the first half. An additional, previously announced RMB1.0 billion worth of A-share repurchase and cancellation plan is currently being implemented, with approximately RMB0.5 billion worth of A-shares repurchased as of now. Moreover, the Company’s Board of Directors approved WuXi AppTec’s first interim dividend plan, distributing RMB3.50 cash dividend for every 10 shares (approximately RMB1.0 billion in total) to shareholders.
[1] As disclosed in 2025 Interim 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 H1 and 2025 H1, WuXi AppTec had a fully-diluted weighted average share count of 2,913,355,532 and 2,897,449,552 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 raised full-year guidance despite external uncertainties.

The Company expects Continuing Operations revenue to resume double-digit growth in 2025, with its year-over-year growth rate raised to 13-17%, up from the prior 10-15%. As a result, the Company expects full-year total revenue of RMB42.5-43.5 billion, up from the prior RMB41.5-43.0 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.

Capex is expected to reach RMB7.0-8.0 billion in 2025. Together with business growth and efficiency improvement, free cash flow is expected to increase from RMB4.0-5.0 billion to RMB5.0-6.0 billion.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "WuXi AppTec once again delivered robust double-digit growth in both revenue and profit in the second quarter, demonstrating the strength of our unique CRDMO business model and the dedication of our global teams. In the first half of 2025, we achieved revenue of RMB20.8 billion, with Continuing Operations revenue growing 24.2% year-over-year, and adjusted non-IFRS net profit growing 44.4% year-over-year, while our backlog for Continuing Operations reached a new record high of RMB56.7 billion."

"Building on this strong momentum and consistent execution, we have raised our 2025 full-year revenue target to RMB42.5-43.5 billion, with Continuing Operations now expected to achieve 13-17% year-over-year double-digit growth, and correspondingly, the free cash flow target up to RMB5.0-6.0 billion. We remain focused on enhancing our core capabilities, expanding capacity, and improving operating efficiency to create greater value for our customers and shareholders."

"Guided by our vision that ‘Every drug can be made and every disease can be treated,’ we are committed to enabling our partners to deliver innovative therapies to patients worldwide. Together, we will continue to advance healthcare innovation and improve lives."

Business Performance by Segments

WuXi Chemistry: CRDMO Business Model Drives Continuous Growth; H1 2025 Revenue Up 33.5% YoY, with TIDES Revenue Up 141.6% YoY
H1 revenue of WuXi Chemistry reached RMB16.30 billion, up 33.5% 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, H1 adjusted non-IFRS gross profit margin steadily improved 5.2pts year-over-year to 49.0%.
Small molecule drug discovery service ("R") continues to generate downstream opportunities. In the past 12 months, we successfully synthesized and delivered more than 440,000 new compounds to customers. In the meantime, 158 molecules were converted from R to D phase in the first half 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.
i. The small molecule CDMO pipeline continued to expand. H1 revenue of small molecule D&M services rose 17.5% year-over-year to RMB8.68 billion. In the first half of 2025, 412 new molecules were added to the small molecule D&M pipeline. As of June 30, 2025, our small molecule D&M pipeline reached 3,409 molecules, including 76 commercial projects, 84 in phase III, 368 in phase II and 2,881 in phase I and pre-clinical stages. That represents an increase of 8 projects in the commercial and phase III stages during the first half of 2025.
ii. 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.
i. With the ramp-up of new capacities released sequentially each quarter last year, H1 TIDES revenue grew 141.6% year-over-year to RMB5.03 billion. As of June 30, 2025, TIDES backlog was up 48.8% year-over-year.
ii. TIDES D&M customers grew 12% year-over-year, while the number of TIDES molecules grew 16% year-over-year.
iii. We continued to build peptide capacity in Taixing. Total reactor volume of Solid Phase Peptide Synthesizers is expected to increase to over 100,000L by the end of 2025.
WuXi Testing[4]: Drug Safety Evaluation Service & Site Management Organization (SMO) Maintain Leading Positions
WuXi Testing revenue reached RMB2.69 billion in H1, and H1 adjusted non-IFRS gross profit margin was 25.1%.
Q2 revenue of lab testing services reached RMB1.00 billion, growing 5.5% year-over-year and 13.2% quarter-over-quarter. Of which, drug safety evaluation services revenue grew 3.4% year-over-year and 10.2% quarter-over-quarter.
H1 revenue of lab testing services grew 0.4% year-over-year to RMB1.89 billion. Due to market impact, its H1 adjusted non-IFRS GPM declined as pricing gradually reflected in revenue along with backlog conversion. Of which, drug safety evaluation services revenue was down 2.2% year-over-year, 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 Suzhou facility has successfully passed 4 consecutive FDA on-site inspections.
H1 revenue for clinical CRO & SMO declined 4.7% year-over-year to RMB0.80 billion due to market pricing impact. Of which, SMO revenue grew 1.5% year-over-year and maintained the industry leading position in China.
During the first half of 2025, our clinical CRO business supported customers to obtain 12 IND approvals and submit for 2 NDA filings; the SMO business supported 61 new drug approvals for customers. The SMO business has supported 317 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 and continuously strengthens drug discovery capabilities in emerging areas. It efficiently generates downstream opportunities for CRDMO model by continuously contributing more than 20% of the Company’s new customers.
Through platform integration, cross-regional collaboration and comprehensive service transformation, we efficiently enable our customers. WuXi Biology revenue reached RMB1.25 billion in H1 2025, a year-over-year increase of 7.1%. Due to market pricing impact, H1 adjusted non-IFRS gross profit margin was down 0.7pts to 36.4%.
We accelerated advancements in in vitro integrated screening technologies and in vivo pharmacology capabilities, driving continued rapid year-over-year revenue growth. The constantly improved competitive edge in non-oncology business has laid a solid foundation for sustained growth throughout the year.
New modality drug discovery services continue to perform well, contributing more than 30% of WuXi Biology’s total revenue.
[4] As disclosed in the 2025 First Quarterly Report, WuXi Testing here includes only the core business of Continuing Operations (similar to the 2024 baseline).

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 Interim Results Presentation and 2025 Interim 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 Interim Report of the Company has not been audited.

Second 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

8,910.40

34.0 %

4,475.02

52.4 %

50.2 %

WuXi Testing

1,396.33

1.6 %

373.99

-27.1 %

26.8 %

WuXi Biology

644.53

6.0 %

235.47

7.8 %

36.5 %

Others

93.89

-55.7 %

67.23

-55.3 %

71.6 %

Discontinued
Operations (Note 1)

99.54

-76.1 %

57.93

N/A

58.2 %

Total

11,144.69

20.4 %

5,209.65

38.0 %

46.7 %

First Half 2025 Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted
non-IFRS
Gross Profit

Change

Adjusted non-
IFRS Gross
Profit Margin

WuXi Chemistry

16,301.37

33.5 %

7,984.86

49.4 %

49.0 %

WuXi Testing

2,688.65

-1.2 %

675.89

-33.6 %

25.1 %

WuXi Biology

1,251.60

7.1 %

455.89

5.0 %

36.4 %

Others

163.48

-49.6 %

97.31

-48.0 %

59.5 %

Discontinued
Operations (Note 1)

394.18

-51.7 %

44.02

N/A

11.2 %

Total

20,799.28

20.6 %

9,257.96

34.9 %

44.5 %

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 Reporting Period 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[5] – Prepared under IFRSs

RMB Million

Three Months Ended June 30,

Six Months Ended June 30,

2025

2024

2025

2024

Revenue

11,144.7

9,259.0

20,799.3

17,240.9

Cost of sales

(6,045.5)

(5,563.8)

(11,687.0)

(10,540.0)

Gross profit

5,099.2

3,695.1

9,112.2

6,700.9

Other income

328.2

269.0

639.5

511.0

Other gains and losses

1,375.7

15.5

2,448.9

208.4

Impairment losses under expected credit losses

("ECL") model, net of reversal

(137.5)

(62.4)

(290.6)

(82.1)

Impairment losses of non-financial assets

(4.0)

–

(73.5)

–

Impairment losses of assets classified as held for sale

(120.7)

–

(120.7)

–

Selling and marketing expenses

(200.3)

(178.4)

(394.4)

(357.5)

Administrative expenses

(649.9)

(667.0)

(1,247.7)

(1,277.5)

R&D expenses

(290.0)

(329.9)

(514.4)

(636.3)

Operating Profit

5,400.5

2,741.9

9,559.4

5,066.8

Share of results of associates

176.3

81.9

240.2

115.8

Share of results of joint ventures

–

(4.4)

0.1

(4.2)

Finance costs

(88.6)

(67.3)

(168.8)

(128.9)

Profit before tax

5,488.1

2,752.2

9,630.8

5,049.6

Income tax expense

(682.6)

(430.2)

(1,247.1)

(768.7)

Profit for the period

4,805.5

2,322.0

8,383.8

4,280.8

Profit for the period attributable to:

Owners of the Company

4,751.1

2,297.6

8,287.3

4,239.8

Non-controlling interests

54.4

24.4

96.4

41.0

4,805.5

2,322.0

8,383.8

4,280.8

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

Consolidated Statement of Profit or Loss[6] (continued) – Prepared under IFRSs

Three Months Ended June 30,

Six Months Ended June 30,

2025

2024

2025

2024

Weighted average number of ordinary shares for calculating EPS

(expressed in shares)

– Basic

2,834,045,549

2,895,745,826

2,840,111,082

2,907,737,554

– Diluted

2,892,304,153

2,899,828,193

2,897,449,552

2,913,355,532

Earnings per share (expressed in RMB per Share)

– Basic

1.68

0.79

2.92

1.46

– Diluted

1.66

0.79

2.89

1.45

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

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

RMB Million

June 30,

December 31,

2025

2024

Non-current Assets

Property, plant and equipment

25,725.6

25,267.8

Right-of-use assets

1,901.4

1,874.8

Goodwill

971.6

972.4

Other intangible assets

511.7

601.0

Interests in associates

1,887.1

2,322.2

Interests in joint ventures

3.4

3.4

Deferred tax assets

511.1

473.1

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

8,504.4

8,943.4

Other non-current assets

153.6

114.7

Biological assets

1,065.1

1,063.0

Total Non-current Assets

41,235.0

41,635.7

Current Assets

Inventories

5,293.6

3,532.1

Contract costs

925.8

912.2

Biological assets

931.8

955.5

Amounts due from related parties

85.9

89.3

Trade and other receivables

9,137.4

9,643.7

Contract assets

825.7

988.8

Income tax recoverable

39.8

87.2

Financial assets at FVTPL

2,942.4

1,234.0

Derivative financial instruments

2.6

–

Other current assets

735.6

734.1

Pledged bank deposits

12.2

22.1

Term deposits with initial term of over three months

3,937.5

4,865.6

Bank balances and cash

17,535.5

13,434.3

42,406.0

36,498.8

Assets classified as held for sale

182.8

2,191.3

Total Current Assets

42,588.7

38,690.2

Total Assets

83,823.8

80,325.8

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

Consolidated Statement of Financial Position (continued)[8]– Prepared under IFRSs

RMB Million

June 30,

December 31,

2025

2024

Current Liabilities

Trade and other payables

7,410.2

7,025.5

Amounts due to related parties

12.5

15.3

Derivative financial instruments

–

202.0

Contract liabilities

2,227.1

2,251.0

Bank borrowings

5,798.2

1,278.6

Lease liabilities

220.9

224.2

Income tax payables

1,296.3

870.8

Convertible bonds

3,517.4

3,493.1

20,482.6

15,360.6

Liabilities directly associated with assets
classified as held for sale

36.4

865.5

Total Current Liabilities

20,518.9

16,226.1

Non-current Liabilities

Bank borrowings

904.9

2,959.5

Deferred tax liabilities

439.4

522.4

Deferred income

959.4

985.6

Lease liabilities

592.1

546.6

Total Non-current Liabilities

2,895.8

5,014.1

Total Liabilities

23,414.7

21,240.2

Net Assets

60,409.1

59,085.6

Capital and Reserves

Share capital

2,872.2

2,888.0

Reserves

57,039.5

55,744.7

Equity attributable to owners of the Company

59,911.7

58,632.7

Non-controlling interests

497.4

452.9

Total Equity

60,409.1

59,085.6

[8] 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[9]

RMB Million

Three Months Ended June 30,

Six Months Ended June 30,

2025

2024

2025

2024

Net profit attributable to the owners of the Company under CAS

4,888.9

2,297.6

8,560.9

4,239.8

GAAP difference[10]

(137.9)

–

(273.6)

–

Net profit attributable to the owners of the Company under IFRSs

4,751.1

2,297.6

8,287.3

4,239.8

Add:

Share-based compensation expenses

142.0

77.2

176.4

165.0

Issuance expenses of convertible bonds

9.8

–

19.6

–

Foreign exchange related losses

270.0

14.6

448.0

29.0

Amortization of acquired intangible assets from merger and
acquisition

6.7

13.4

13.8

27.0

Gains or losses from divestiture, restructuring and resource
integration initiatives

131.3

–

139.9

–

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

5,310.9

2,402.7

9,085.0

4,460.7

Add:

Realized and unrealized (gains)losses from venture capital investments

(1,673.8)

51.9

(2,770.1)

(92.7)

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

(0.0)

4.4

(0.1)

4.2

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

3,637.1

2,459.1

6,314.8

4,372.2

On July 28, 2025 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence ("AI") and machine learning to enable the successful development of pharmaceuticals and biologics, reported that Vin Singh, CEO, will participate in a fireside chat and one-on-one meetings at BTIG’s Annual Virtual Biotechnology Conference, being held Tuesday, July 29 through Wednesday, July 30 (Press release, Bullfrog AI, JUL 28, 2025, View Source [SID1234654568]).

Schedule your 30 min Free 1stOncology Demo!
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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

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Fireside Presentation Details

Date: Wednesday, July 30, 2025

Time: 11:20 a.m. ET

To request access to the presentation, contact: [email protected]. Registered attendees can request one-on-one meetings with BullFrog AI management via your BTIG banking representative.

If you are unable to attend the conference and would like to schedule a meeting with BullFrog AI management, please contact [email protected].

On July 28, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported the launch of the PanTheR Post-Marketing Registry Study (NCT06805461) (Press release, Renovorx, JUL 28, 2025, View Source [SID1234654585]).

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The initiation of this study demonstrates RenovoRx’s commitment to innovation and RenovoCath’s current and future potential. The study will serve as a critical tool for understanding RenovoCath’s safety and effectiveness in a real-world setting, providing valuable insights into long-term effectiveness and patient outcomes. Patient enrollment is expected to commence before the end of September 2025. Each cancer center participating in the registry study will purchase RenovoCath devices for use in the study from RenovoRx.

A registry study, or post-approval study, is a clinical study that involves collecting data on the long-term use and performance of a medical device, such as RenovoCath, after it has been cleared for market by the FDA. PanTheR is a multi-center, post-marketing observational registry study designed to evaluate the long-term safety of and survival outcomes for patients diagnosed with solid tumors who are treated using RenovoCath for targeted drug delivery. PanTheR will capture real-world data on the utilization of RenovoCath and generate additional safety information across a broader range of solid tumors. This data may be used to inform future clinical trial designs.

The first of multiple clinical sites to initiate patient enrollment in the PanTheR study is the University of Vermont (UVM) Cancer Center, with Dr. Conor O’Neill, Assistant Professor at the UVM Larner College of Medicine and surgical oncologist at the UVM Medical Center, serving as Principal Investigator. Additional clinical sites in the post-marketing registry study are expected to initiate enrollment soon.

"PanTheR marks a significant step forward in our commitment to better understand and demonstrate the long-term safety and therapeutic potential of our RenovoCath device," said Leesa Gentry, Chief Clinical Officer of RenovoRx. "By collaborating with leading cancer centers across the U.S, this is a low-cost study that will yield valuable data. By gathering real-world data across diverse cancer types and clinical environments, PanTheR aims to advance innovation and inform evidence-based treatment strategies, which will ultimately enhance care and potentially improve outcomes for future patients facing solid tumors."

"We are very pleased that the UVM Cancer Center has been initiated to begin enrollment in the PanTheR study," Ms. Gentry continued. "The UVM Cancer Center offers leading-edge care, provided by highly skilled oncologists priding themselves on using the latest research and education for informed care. We believe our study will be an excellent fit within University of Vermont’s oncology program."

"We are proud to be part of this important study that holds the potential to transform the way we treat solid tumors," said Dr. Conor O’Neill of the University of Vermont Cancer Center. "I believe the RenovoCath device offers a novel approach for drug delivery, which may have the potential to improve patient outcomes. This study emphasizes our strong commitment to continually advance treatment options offered to our patients by offering access to the latest innovations that have the potential to transform the treatment paradigm for solid tumors."

To learn more about PanTheR (NCT06805461), visit clinicaltrials.gov for details: View Source;rank=1.

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

On July 28, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor (Press release, Celcuity, JUL 28, 2025, View Source [SID1234654569]).

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In the trial, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant (based on a hazard ratio [HR] of 0.24, 95% confidence interval [CI] 0.17-0.35; p<0.0001). The mPFS, as assessed by blinded independent central review ("BICR"), was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.

The gedatolisib doublet also demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 67% compared to fulvestrant (HR of 0.33, 95% CI 0.24-0.48; p<0.0001). The mPFS, as assessed by BICR, was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.

The topline efficacy data from the VIKTORIA-1 PIK3CA wild-type cohort established several new milestones in the history of drug development for HR+/HER2- advanced breast cancer:

· The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.

· The 7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of therapy.

· Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA wild-type ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.

Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial said: "Patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease has progressed while on, or after, treatment with a CDK4/6 inhibitor typically derive limited benefit from subsequent endocrine-based therapy. The topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing. To my knowledge, we have not seen Phase 3 results in patients with HR-positive, HER2-negative advanced breast cancer before where there was a quadrupling of the likelihood of survival without disease progression relative to the study control."

Treatment discontinuation due to a treatment-related adverse event for the gedatolisib triplet and gedatolisib doublet was lower than was observed in Arm D of the Phase 1b trial in patients with ABC, and lower than observed in any Phase 3 trials for currently approved drug combinations in HR+/HER2- ABC. Additionally, the gedatolisib triplet and gedatolisib doublet were better tolerated than was observed in the Phase 1b trial in patients with ABC, including lower rates of hyperglycemia and stomatitis.

Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity said: "The topline data from VIKTORIA-1 demonstrate the potential for gedatolisib to become a transformative new medicine for the treatment of patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease progressed on or after treatment with CDK4/6 inhibitors. The 7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens are potentially paradigm shifting results. We are also very excited that treatment with gedatolisib combined with fulvestrant with or without palbociclib was well-tolerated by the VIKTORIA-1 patients and that only a few patients discontinued treatment due to an adverse event."

Brian Sullivan, Chairman, Chief Executive Officer and co-founder of Celcuity said, "The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population. We are excited about the potential opportunity to provide a breakthrough therapeutic option for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer."

Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year. Celcuity expects to submit a New Drug Application for gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025. Topline data for the VIKTORIA-1 PIK3CA mutation cohort is expected by the end of 2025.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call on Monday, July 28, 2025, at 8:00 a.m. ET to discuss the topline results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. A replay of the webcast will be available on the Celcuity website following the live event.

Notes

HR+/HER2- Breast cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer.3 Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Survival rates are low with 30% of patients anticipated to live beyond five years after diagnosis.2 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

VIKTORIA-1

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is enrolling subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility criteria and do not have confirmed PI3KCA mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who meet eligibility criteria and have confirmed PI3KCA mutations (MT) are randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet.

Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data.