On August 1, 2025 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, reported that it has made a strategic equity investment in I-Mab, (”I-Mab”), a company listed on the Nasdaq Global Market (”Nasdaq”) trading under the symbol ”IMAB" (Press release, Everest Medicines, AUG 1, 2025, View Source [SID1234654709]).

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"This strategic equity investment furthers our plan to be an active player in next-generation oncology programs across global markets. Everest and its Board of Directors believe this investment recognizes I-Mab’s unique clinical translational capabilities in the U.S., which are complementary and synergistic with the Company’s strong Asia presence," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "As a biotech pioneer in China, Everest has built internally developed pipeline assets including mRNA therapeutic cancer vaccines and in vivo CAR-T therapies targeting cancer and autoimmune diseases. Our areas of focus meaningfully intersect with I-Mab’s differentiated 4-1BB platform and bispecific antibody pipeline, including oncology candidates Givastomig (Claudin 18.2 x 4-1BB bispecific antibody) and Ragistomig (PD-L1 x 4-1BB bispecific antibody), both promising programs that we are closely watching. Furthermore, both companies may be able to leverage their combined expertise to run clinical programs in both China and the U.S. Everest is proud to develop innovative and valuable therapies that can benefit cancer patients globally."

Financial Terms and Corporate Updates:

I-Mab reported an underwritten offering of 33,333,334 American Depositary Shares (the "ADSs") representing 76,666,668 ordinary shares at an offering price of $1.95 per ADS, for total gross proceeds of approximately US$65 million. Under the arrangement of this offering, Everest will subscribe for 15,846,154 ADSs (the "Subscription"), with an aggregate consideration of US$30.9 million. Upon completion of the Subscription, the Company shall hold an aggregate of 15,846,154 ADSs and 6,078,571 ordinary shares, representing approximately 16.1% of the total issued share capital of I-Mab, inclusive of 6,078,571 ordinary shares already held by Everest.

As all of the applicable percentage ratios of the Subscription are less than 5%, the Subscription is not subject to the announcement or shareholders’ approval requirements under Chapter 14 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited.

The investment in I-Mab shares is expected to be booked as "investments" under non-current assets on Everest’s balance sheet. Changes from "mark-to-market" are expected to be reflected in fair value through other comprehensive income in the statement of changes in equity and the investment has no impact on the Company’s P/L statement and will not appear as an operating expense.

I-Mab is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. There are three pipeline products of I-Mab in clinical stage, Givastomig (Claudin 18.2 x 4-1BB bispecific antibody), Ragistomig (PD-L1 x 4-1BB bispecific antibody) and Uliledlimab (CD73 antibody).

I-Mab recently presented positive Phase 1b dose escalation results for givastomig in combination with immunotherapy in first line gastric cancer (ORR of 83%) at the ESMO (Free ESMO Whitepaper) GI 2025 conference which are summarized here.

On August 1, 2025 Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, "Median" or the "Company"), manufacturer of eyonis, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a leading provider of AI-based image analyses and central imaging services for oncology drug developers, reported the success of its capital increase targeting institutional and retail investors through a priority subscription period, a public offering, and a private placement with qualified investors (together, the "Offering") (Press release, MEDIAN Technologies, AUG 1, 2025, View Source [SID1234654710]). The Offering was exclusively open to investors, whether retail or institutional, subscribing for a minimum amount of €100,000 per investor. As a result, subscription requests for a total amount below €100,000 per investor were not allocated.

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The Offering, launched on July 23, 2025, amounted to a total gross proceed of 23.9 million euros, including the issuance premium. The Company exercised the extension clause granted by the Board of Directors as part of the transaction for an amount of 1.9 million Euros.

"I would like to thank all our investors—both institutional and individual—for their support and trust during this capital increase. We are particularly proud to have expanded and strengthened our shareholder base with the participation of renowned Swedish, US, French, German and UK investors (Lungstrom Family Office, Lion Point Life Science Partners, Celestial Successor Fund, Matignon Finance, Invus, Herald Investment Trust, et Tragara Holdings). We also welcome the continued commitment of representatives of the Brag family and friends, who have renewed their trust in the future of the Company.

"This equity financing adds to the up to €37.5 million EIB financing line signed in July 2025 and allows us to meet the contractual conditions to draw down the first €19 million tranche. The Company’s cash runway is now extended through the fourth quarter of 2026, and potentially way beyond with the full exercise of the warrants, which can generate additional equity of €51.7 million", said Fredrik Brag, CEO and Founder of Median Technologies.

"This transaction provides us with the solid financial resources needed for the commercial launch of our Software as a Medical Device eyonis LCS in the United States, while also strengthening our position to finalize negotiations with commercial partners for the distribution of our eyonis LCS product. Furthermore, the funds raised will also enable us to continue and accelerate our technological and clinical development efforts for the next medical imaging software devices in our eyonis suite—namely, eyonis IPN for the incidental detection of lung cancer, and eyonis HCC for the early diagnosis of primary liver cancer", Brag added.

Main terms of the Offering

The Offering, carried out with the cancellation of shareholders’ preferential subscription rights and including a five-trading-day subscription period (on both irreducible and reducible bases), amounted to total gross proceeds of 23.9 million euros, including the issuance premium.

In accordance with the Regulation (EU) 2017/1129, the Offering was addressed to investors, whether retail or institutional, who will subscribe to it for a total consideration of at least €100,000 per investor.

In total, the Offering resulted in the issuance of 14,424,541 new ordinary shares of the Company (the "New Shares"), each accompanied by a warrant (the "Warrants" and, together with the New Shares to which they are attached, the "ABSA"). The new ABSA were issued at a price of €1.66 per ABSA, including the issuance premium, representing approximately 72.3% of the Company’s existing share capital on a non-diluted basis. This price reflects a nominal discount of 17.9% compared to the volume-weighted average price (VWAP) of the Company’s shares over the twenty trading days preceding and through the date of July 18, 2025.

The Offering was allocated as follows:

On an irreducible and reducible basis during the priority subscription period to existing shareholders: 9,201,890 new ABSA, representing 64% of the capital increase,
As part of the public offering in France: 241,224 new ABSA, representing 2% of the capital increase,
As part of the Global placement targeting qualified investors (the "Global Placement"), which included (a) a private placement to a limited number of accredited investors (as defined in Rule 501(a) of the U.S. Securities Act of 1933 (the "Securities Act")) and/or qualified institutional buyers (as defined in Rule 144A of the Securities Act), and (b) an international offering outside the United States in "offshore transactions" pursuant to Regulation S of the Securities Act ("Regulation S"), (A) within the European Union (including France), to qualified investors as defined in Article 2(e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017, as amended, and (B) outside the European Union (excluding South Africa, Japan, Australia, and Canada) in accordance with applicable laws in each relevant jurisdiction: 4,981,427 new ABSA, representing 35% of the capital increase.
Settlement and delivery of the ABSA and their admission to trading on the Euronext Growth Paris market is expected to take place on August 5, 2025. The New Shares will be of the same class and fully fungible with the Company’s existing ordinary shares, will carry all rights attached to existing shares, and will be admitted to trading on Euronext Growth Paris under the same ISIN code: FR0011049824 – ALMDT.

Two warrants attached to the new shares entitle the holder thereof to subscribe for three new ordinary shares of the Company at a total exercise price of €7.17, i.e., an exercise price of €2.39 per new ordinary share. The theoretical value of each warrant is €0.90 per new ordinary share, based on the Black-Scholes model and assuming a volatility of 76%. The warrants will be detached from the new shares immediately upon issuance and will be admitted to trading on Euronext Growth under ISIN code FR0014011D04.

The full exercise of the 14,424,541 warrants subscribed as part of the Offering would represent additional gross proceeds of 51.7 million euros. The warrants will expire 30 months after their issuance date, i.e., on 5 February 2028.

The Offering did not and will not require the preparation of a prospectus subject to approval by the French Financial Markets Authority (Autorité des Marchés Financiers), in accordance with Article 1.4.d) of Regulation (EU) 2017/1129 of the European Parliament and of the Council dated June 14, 2017, as amended.

Intended use of the transaction’s net proceeds

Approximatively one-third of the net proceeds will be used to support eyonis Lung Cancer Screening (LCS) progress towards major milestones consisting of commercial launch and sales development in the U.S,
Approximatively one-third of the net proceeds will be used to accelerate the expansion of Median’s proprietary suite of Software as a Medical Device, eyonis, for image-based early cancer diagnosis, notably the scientific and clinical development of Software as a Medical Devices for incidental findings of pulmonary nodules (eyonis IPN) and liver cancer early diagnosis (eyonis HCC), and
Approximately one-third of the net proceeds will be used to finance the Company’s general corporate needs and to support its cash position through the fourth quarter of 2026.
Furthermore, successful settlement and delivery of the Offering is expected to allow the Company to fulfill its contractual obligations with the European Investment Bank (EIB), enabling the drawing down of the €19 million first tranche of the new financing facility without delay. The signature of the new EIB financing facility of a total amount of €37.5 million had been announced on July 11, 2025.

Impact of the Offering on the Company’s shareholding structure

Shareholders

Before Offering

After completion of the Offering

Shares

% shareholding

Shares

% shareholding

Furui Medical Science Company Luxembourg

1,507,692

7.8%

1,507,692

4.5%

Celestial successor fund LP

1,288,958

6.6%

2,553,312

7.5%

Founders, Managers, Employees

1,184,998

6.1%

1,245,240

3.7%

Canon Inc.

961,826

4.9%

961,826

2.8%

Abingworth bioventures VI LP

956,819

4.9%

956,819

2.8%

Free float

13,549,988

69.7%

26,649,933

78.7%

Total

19,450,281

100.00%

33,874,822

100.00%

Financial intermediary

TP ICAP Midcap acted as global coordinator and bookrunner for the Offering.

Risk factors

The principal risk factors related to the Offering are spelled out below:

Shareholders who did not subscribe to the Offering will have their percentage interest in the Company’s equity diluted as a result of the issuance of the New Shares, and may experience further dilution upon the potential exercise of the Warrants as well as, more generally, through any future capital increases that may be required to support the Company’s financing needs.
The market price of the Company’s shares could fluctuate and fall below the subscription price of the ABSAs and/or not reach a sufficient level to make the exercise of the BSAs attractive.
The volatility and the liquidity of the Company’s shares could fluctuate significantly.
Those other risk factors relating to the Company and its activities contained in Note 6, Section "P. Specific Risk Factors" to the Company’s Annual Financial Report, available on the Company’s website www.mediantechnologies.com in the "Investors" section.

On August 1, 2025 Ono reported Consolidated Financial Results for the First Quarter of the Fiscal Year Ending March 31, 2026 (Filing, 3 mnth, JUN 30, Ono, 2025, AUG 1, 2025, View Source [SID1234655578]).

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On August 1, 2025 Moderna, Inc. (NASDAQ:MRNA) reported financial results and provided business updates for the second quarter of 2025 (Press release, Moderna Therapeutics, AUG 1, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=4672625806029436&symbol=MRNA [SID1234654692]).

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"In the last three months, we advanced our pipeline with positive Phase 3 flu vaccine efficacy data and expanded our commercial portfolio with three new U.S. FDA approvals to drive future sales growth," said Stéphane Bancel, Chief Executive Officer of Moderna. "Today, we are updating our 2025 financial framework, reducing the high end of this year’s expected revenue range by $300 million due to the timing of shipments. We continue to operate with financial discipline and are improving expected annual operating expenses in 2025 by approximately $400 million. Looking forward, we have important catalysts over the next six months across our infectious disease and oncology programs that will help us deliver on the promise of our mRNA platform for patients."

Recent progress includes:

Commercial Updates

COVID-19: The Company reported $114 million in Spikevax sales in the second quarter of 2025, which includes $88 million of U.S. sales and $26 million of international sales. Moderna recently announced U.S. Food and Drug Administration (FDA) approval for the supplemental Biologics License Application (sBLA) for Spikevax in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company’s COVID-19 vaccine (mRNA-1273) was previously available for pediatric populations under Emergency Use Authorization (EUA). Additionally, the Company announced it has received final approval from the European Medicines Agency for Spikevax targeting the LP.8.1 variant in individuals six months of age and older. Moderna also announced FDA approval for mNEXSPIKE (mRNA-1283), a next-generation vaccine against COVID-19, for use in all adults aged 65 and older, as well as individuals aged 12-64 years with at least one underlying risk factor.

RSV: The Company reported negligible mRESVIA sales in the second quarter of 2025. Moderna’s RSV vaccine for adults aged 60 years and older has been approved in approximately 40 countries. Additionally, Moderna recently announced that the FDA has approved mRESVIA (mRNA-1345), expanding the previous indication, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease.

Second Quarter 2025 Financial Results

Revenue: Total revenue for the second quarter of 2025 was $142 million, a 41% decrease from $241 million in the same period in 2024. The decline was primarily driven by lower COVID vaccine sales, which totaled $114 million in the quarter. Demand is expected to be concentrated in the second half of the year, aligning with the fall and winter seasons as the vaccine continues to transition into a seasonal respiratory product.

Cost of Sales: Cost of sales for the second quarter of 2025 was $119 million, which included third-party royalties of $6 million, inventory write-downs of $38 million, and unutilized manufacturing capacity and wind-down costs of $52 million. Cost of sales was relatively flat compared to the same period in 2024. The increase in cost of sales as a percentage of net product sales, to 105% from 62% in the second quarter of 2024, was mainly driven by the impact of lower net product sales.

Research and Development Expenses: Research and development expenses for the second quarter of 2025 were $700 million, a 43% decrease compared to the same period in 2024. The reduction was primarily driven by lower clinical trial and manufacturing expenses, reflecting reduced production spending, program wind-downs, and the timing of trial activities across the Company’s respiratory vaccine portfolio.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of 2025 were $230 million, a 14% decrease compared to the same period in 2024. The decline was primarily driven by broad-based cost reductions across consulting and external services, personnel-related expenses, and commercial and marketing activities, reflecting the Company’s continued cost discipline and ongoing efforts to streamline operations.

Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets.

Net Loss: Net loss was $(0.8) billion for the second quarter of 2025, compared to $(1.3) billion for the second quarter of 2024.

Loss Per Share: Loss per share was $(2.13) for the second quarter of 2025, compared to $(3.33) for the second quarter of 2024.

Cash Position: Cash, cash equivalents and investments as of June 30, 2025, were $7.5 billion, compared to $8.4 billion as of March 31, 2025. The decrease during the quarter was primarily due to ongoing research and development expenses and other operating activities.

2025 Financial Framework

Revenue: The Company updated its 2025 projected revenue range to $1.5 to $2.2 billion, reflecting a $300 million reduction at the high end of the range. This is primarily driven by the timing shift of deliveries of contracted revenue for the U.K. into the first quarter of 2026. For the second half of the year, Moderna expects a revenue split of 40-50% in the third quarter with the balance in the fourth quarter of 2025.

Cost of Sales: Cost of sales for 2025 is expected to be approximately $1.2 billion.

Research and Development Expenses: Full-year 2025 research and development expenses are anticipated to be $3.6 to $3.8 billion, lowered from previous expectations of approximately $4.1 billion.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2025 are projected to be approximately $1.1 billion.

Income Taxes: The Company continues to expect its full-year tax expense to be negligible.

Capital Expenditures: Capital expenditures for 2025 are expected to be approximately $0.3 billion, lowered from previous expectations of approximately $0.4 billion.

Cash and Investments: Year-end cash and investments for 2025 are projected to be approximately $6 billion.

Recent Progress and Upcoming Late-Stage Pipeline Milestones

Respiratory vaccines:

Seasonal flu vaccine: In June, Moderna announced positive Phase 3 efficacy results for its seasonal flu vaccine (mRNA-1010), which demonstrated superior relative vaccine efficacy that was 26.6% (95% CI; 16.7%, 35.4%) higher than a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older. The Company is submitting mRNA-1010 data for publication, presenting data at medical conferences and preparing to file for FDA approval.

Seasonal flu + COVID vaccine: Moderna shared positive Phase 3 immunogenicity data for its flu/COVID combination vaccine (mRNA-1083) for adults aged 50 years and older at its 2024 R&D Day event. In May 2025, the Company announced that in consultation with the FDA, it had voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083 with the plan to resubmit after vaccine efficacy data from the Phase 3 trial of its investigational seasonal flu vaccine (mRNA-1010) are available. The Company is engaging with regulators on data requirements for resubmitting the BLA for mRNA-1083.

Latent and other vaccines:

Cytomegalovirus (CMV) vaccine: The Company shared 36-month durability data from a Phase 2 extension trial of its CMV vaccine candidate (mRNA-1647) at the ESCMID 2025 Global Congress. The pivotal Phase 3 study of mRNA-1647 is fully enrolled and has now accrued sufficient cases for evaluation of the primary endpoint of the study, evaluating its efficacy, safety and immunogenicity in the prevention of primary infection in women of childbearing age. Moderna is updating its analysis plan to incorporate additional secondary endpoints. The Company remains blinded and anticipates a Phase 3 final analysis in 2025.

Norovirus vaccine: The Phase 3 study evaluating the efficacy, safety and immunogenicity of Moderna’s trivalent vaccine against norovirus (mRNA-1403) is accruing cases. The timing of the Phase 3 readout will be dependent on case accruals.

Oncology therapeutics:

Intismeran autogene: Moderna continues to make progress on advancing mRNA-4157 in the clinic. In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled. Two non-small cell lung cancer (NSCLC) Phase 3 studies for those with and without prior neoadjuvant treatment are enrolling. Separate randomized Phase 2 studies for high-risk muscle invasive and high-risk non-muscle invasive bladder cancer are also enrolling, and a randomized Phase 2 study for adjuvant renal cell carcinoma is fully enrolled. Further, Moderna and Merck have launched a new Phase 2 study of first-line treatment for patients with metastatic melanoma.

Checkpoint adaptive immune modulation therapy (AIM-T): The Phase 1/2 study of mRNA-4359 is ongoing and the Phase 2 study, which includes cohorts in first-line metastatic melanoma and first-line metastatic NSCLC, is enrolling NSCLC patients.

The Company recently announced that three abstracts on its investigational mRNA therapeutics have been accepted for presentation at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

Rare disease therapeutics:

Propionic acidemia (PA) therapeutic: In an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with PA, Moderna’s investigational therapeutic (mRNA-3927) has been generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria. Early results suggest potential decreases in annualized metabolic decompensation event (MDE) frequency compared to pre-treatment, and the majority of patients have elected to continue on the open label extension study. The Company’s PA program is in a registrational study.

Methylmalonic acidemia (MMA) therapeutic: Moderna’s investigational therapeutic for MMA (mRNA-3705) has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. The FDA and Moderna have agreed on the pivotal study design. The Company expects to start a registrational study in 2025.

Moderna Corporate Updates

Moderna announced an organizational restructuring that will reduce its global workforce by approximately 10%. The Company anticipates a total headcount of under 5,000 by year-end.

Company Accolades

Moderna was named to the Boston Business Journal’s annual list of the Most Charitable Companies in Massachusetts (third consecutive year)

Moderna was recognized as a top-scoring company on Disability:IN’s Disability Equality Index and a Best Place to Work for Disability Inclusion (fourth consecutive year)

Key 2025 Investor and Analyst Event Dates

Analyst Day: November 20

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on August 1, 2025. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: View Source

Webcast: View Source

The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

On August 1, 2025 Shanghai Junshi Bioscience reported 2025 interim results (Presentation, Shanghai Junshi Bioscience, AUG 1, 2025, View Source [SID1234656183]).

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