Median Technologies Announces Successful Upsized Capital Increase of € 50 Million

On June 3, 2026 Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, "Median" or the "Company"), developer 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 clinical trials in the biopharmaceutical industry, reported the success of its upsized capital increase without shareholders’ preferential subscription rights, by way of an issuance of new ordinary shares (the "New Shares"). The New Shares were offered in the framework of (i) a public offering in France and a global placement to certain qualified investors for an amount of €40 million and (ii) an offering reserved to Katarina Martinson AB, Venture S.a.r.l, and Nordica Life (Bermuda) Ltd (the "Guarantors") for an amount of €10 million

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The Offering (as such term is defined below), launched on May 27, 2026, amounted to a total gross proceed of €50 million, including the issuance premium. The initial capital increase of €40 million capital increase was multiple times oversubscribed, demonstrating strong market support. The Offering attracted strong demand from both existing and new institutional investors across Europe, the United States and the United Kingdom, alongside significant participation from retail investors. Given the level of oversubscription recorded, the Reserved Offering to the Guarantors for a maximum amount of € 10 million was fully implemented, bringing the total amount of the transaction to € 50 million.

"On behalf of Median Technologies, I would like to thank all investors—both institutional and retail—for their participation in this capital increase and their confidence in our vision and strategy. This transaction has enabled us to further diversify and strengthen our shareholder base with leading institutional investors from Europe, the United States, and the United Kingdom. We are also grateful for the continued support of Lion Point Capital, which joined Median in 2025, as well as the Guarantors, whose commitment contributed significantly to the success of this transaction," said Fredrik Brag, CEO and Founder of Median Technologies.

"With this financing, Median Technologies believes that it is well positioned to execute its strategic roadmap. The proceeds provide funding visibility into the first half of 2028 and could extend through mid-2029 upon the full exercise of the warrants issued in 2025 and still outstanding," Fredrik Brag added.

"Our priorities are clear: the commercial deployment of eyonis LCS in the United States, its commercial launch in Europe following the expected CE marking in the coming weeks, and the expansion of our eyonis platform into additional cancer indications. We believe early cancer diagnosis is a significant opportunity to improve patient outcomes while helping healthcare systems address the growing burden of cancer. This financing provides the resources to accelerate that mission and create long-term value for patients, healthcare providers, and shareholders alike," concluded Fredrik Brag.

Main Terms of the Offering

Pursuant to the 3rd and 5th resolutions of the general meeting of the shareholders held on October 31, 2025 (the "General Meeting") and the sub-delegation of powers from the Company’s Board of Directors (Conseil d’Administration) held on May 26, 2026, the Chief Executive Officer of the Company decided, on June 3, 2026, to issue 10,000,000 New Shares, excluding the Commission (as such term is defined below) at a price of €5.00 per New Share (i.e. €0.05 nominal value and €4.95 issue premium), representing approximately 31% of the Company’s existing share capital on a non-diluted basis, and corresponding to a capital increase of a total amount of €50,000,000, including issue premium. The price per New Share represents a discount of (i) 2.85% to the volume-weighted average prices (VWAP) of the Company’s shares recorded during the 20 trading sessions preceding May 26, 2026 (inclusive) and (ii) 11.3% to the closing price as of May, 26, 2026.

The New Shares issued in connection with the Offering comprised:

a global offering including (a) a public offering in France, mainly aimed at retail investors (the "Public Offering") and (b) an international offering to qualified investors in certain countries, including (a) in the United States of America, by way of a private placement by the Company to a limited number of "qualified institutional buyers" as defined in Rule 144A under the U.S. Securities Act of 1933, as amended (the "Securities Act"), in reliance on an exemption from the registration requirements of Section 4(a)(2) of the Securities Act, and (b) outside the United States in offshore transactions in accordance with Regulation S under the Securities Act (the "Global Placement", together with the Public Offering, "Global Offering"); and
a share capital increase without shareholders’ preferential subscription rights reserved for a category of persons, for the benefit of Guarantors, in accordance with Article L.225-138 of the French Commercial Code (the "Reserved Offering", together with the "Global Offering", the "Offering",).
As part of the Public Offering: 331,790 New Shares were allocated, representing 3.3 % of the Offering;
In the Global Placement: 7,668,210 New Shares were allocated, representing 76,7 % of the Offering including 4,000,000 New Shares subscribed for and allocated to the Guarantors; and
In the Reserved Offering: 2,000,000 New Shares subscribed for and allocated to the Guarantors, representing 20% of the Offering.
In accordance with the subscription commitments granted to the Company, the Guarantors subscribed in the Global Offering for a total amount of €20,000,000 in the following proportions:

New Shares

Subscribed amount (€)

% of the Global Offering

Katarina Martinson AB

2,666,667

13,333,333

33.3 %

Venture S.a.r.l

933,333

4,666,667

11.7 %

Nordica Life (Bermuda) Ltd

400,000

2,000,000

5.0 %

TOTAL

4,000,000

20,000,000

50 %

In connection with the Reserved Offering, the Guarantors also subscribed, in accordance with the underwriting commitments granted to the Company, for a total amount of €10,000,000 in the following proportions:

New Shares

Subscribed amount (€)

% of the Global Offering

Katarina Martinson AB

1,333,333

6,666,667

16.7 %

Venture S.a.r.l

466,667

2,333,333

5.8 %

Nordica Life (Bermuda) Ltd

200,000

1,000,000

2.5 %

TOTAL

2,000,000

10,000,000

25 %

In consideration for their subscription and underwriting commitments, each Guarantor is in any event entitled to the payment of a fee equal to 8% of the aggregate amount of its subscription and underwriting commitments, i.e. a total aggregate amount of €2,400,000 for the Guarantors, payable by way of set-off of a certain and payable receivable in new shares on the settlement-delivery date of the Offering, representing 480,000 new ordinary shares (the "Commission").

Intended use of the Offering’s net proceeds

The net proceeds from the Offering will be used:

To accelerate commercialization of eyonis LCS in the U.S. and launch in target European countries after CE marking achievement,
To develop eyonis for incremental cancer indications,
For Company’s working capital and general corporate purposes.
The Offering will extend Company’s cash runway until first half-year 2028.

In case of the full exercise of the 12 million warrants issued in July 2025 that are currently outstanding, with an expiration date in January 2028 at an exercise price of €2.39 per share (remaining exercise value of €44.3 million), the cash runway of the Company would be extended to mid-2029.

Settlement of the New Shares

Settlement of the New Shares and their admission to trading on the multilateral trading facility of Euronext Growth Paris are expected to take place on June 5, 2026. The New Shares will be of the same class as, and fungible with, the existing ordinary shares, will carry all rights attached to the existing shares and will be admitted to trading on Euronext Growth Paris under the same ISIN code: FR0011049824 – ALMDT.

Impact of the Offering on the Company’s shareholding structure and shareholders’ equity

Before the Offering, and based on the information made available to the Company, the share capital and number and percentage of voting rights were allocated as follows:

non diluted basis

diluted basis(1)

Number of shares / voting rights

% of share capital and voting rights

Number of shares / voting rights

% of share capital and voting rights

Anne Helen & Fredrik Lungström

5,215,396

13.7 %

11,540,692

17.77 %

Celestial Successor Fund, LP

2,553,312

6.7 %

6,577,343

10.13 %

Matignon Finance

1,625,099

4.3 %

2,586,542

3.98 %

Furui Medical Science Company

1,507,692

3.9 %

1,507,962

2.32 %

Lion Point L P

1,506,024

3.9 %

3,765,060

5.80 %

Canon Inc

961,825

2.5 %

961,825

1.48 %

Free float

24,833,039

65.0 %

38,017,120

58. 53 %

Total

38,202,387

100.00%

64,956,544

100.0%

(1) After acquisition of the free shares granted by the Company and exercise of the stock options and share warrants issued by the Company as of 31 December 2025, corresponding to 26,754,157 shares of the Company.

After the Offering, and based on the information made available to the Company, the share capital and number and percentage of voting rights is allocated as follows:

non diluted basis

diluted basis(1)

Number of shares / voting rights

% of share capital and voting rights

Number of shares / voting rights

% of share capital and voting rights

Anne Helen & Fredrik Lungström

5,215,396

10.7%

11,540,692

15.30%

Celestial Successor fund LP

2,553,312

5.2%

6,577,343

8.72%

Matignon Finance

1,625,099

3.3%

2,586,542

3.43%

Furui Medical Science Company

1,507,692

3.1%

1,507,962

2.00%

Lion Point L P

1,506,024

3.1%

3,765,060

4.99%

Canon Inc

961,825

2.0%

961,825

1.28%

Katarina Martinson AB

4,320,000

8.9%

,4,320,000

5.73%

Venture S.a.r.l

1,512,000

3.1%

1,512,000

2.00%

Nordica Life (Bermuda) Ltd

648,000

1.3%

648,000

0.83%

Free float

28,833,039

59.2%

,42,017,120

55.70%

Total

48,682,387

100.0%

75,436,544

100.00%

(1) After acquisition of the free shares granted by the Company and exercise of the stock options and share warrants issued by the Company as of 31 December 2025, corresponding to 26,754,157 shares of the Company.

For illustrative purposes, the impact of the Offering on the ownership interest of a shareholder holding 1% of the Company’s share capital prior to the Offering and who did not subscribe to it, and on the Company’s shareholders’ equity per share, is as follows, based on the number of shares comprising the Company’s share capital as of the date of this press release, after deduction of treasury shares, and on consolidated shareholders’ equity attributable to the Group as of 31 December 2025:

Share of consolidated shareholders’ equity per share, in euros.

Ownership interest, in %.

Non-diluted basis

Diluted basis(1)

Non-diluted basis

Diluted basis(1)

Before the Offering

-0.920€

0.590€

1%

0.588%

After the Offering (excluding the Commission).

0.308€

1.315 €

0.793%

0.491%

After the Offering (including the Commission).

0.354€

1.203 €

0.785%

0.506%

(1) After acquisition of the free shares granted by the Company and exercise of the stock options and warrants issued by the Company as of 31 December 2025, corresponding to 26,754,157 shares of the Company.

Financial intermediaries

TD Cowen and Stifel Europe Securities SAS acted as Joint Global Coordinators and Joint Placement Agents for the Offering (together, the "Placement Agents"). The Offering was subject to a placement agreement between the Company and the Placement Agents, which was entered into on June 3, 2026 (the "Placement Agreement").

Lock-up and undertakings

The Company has entered into a lock-up undertaking for a period of 90 days following the date of the settlement and delivery of the Offering, subject to certain customary exceptions.

The members of the Company’s Board of Directors and Executive Committee, including the Chief Executive Officer, have undertaken to retain the Company’s shares that they hold for a period of 90 days from the settlement-delivery date of the Offering, subject to certain customary exceptions. Lion Point Capital has also undertaken not to dispose of the shares it holds for a period of 90 days as from the settlement-delivery date of the Offering, subject to certain customary exceptions.

Eligibility of the Offering for PEA / PEA-PME schemes and the regime under Article 150-0 B ter of the French Tax Code, CGI, relating to the reinvestment of capital gains

Shares of Median Technologies are fully eligible for inclusion in share savings plans, or PEA, and PEA-PME accounts, which benefit from the same tax advantages as the standard PEA.

In the event of a contribution of securities to a company controlled by the contributor, the capital gain is placed under tax deferral pursuant to Article 150-0 B ter of the French Tax Code. The sale, within three years, of the contributed securities results in the termination of this tax deferral, unless the Company undertakes to reinvest 60% of the proceeds from the sale in an economic activity within two years of the sale. The sale proceeds may notably be invested in the cash subscription to the initial share capital or to a capital increase of one or more companies that meet the conditions provided for in Article 150-0 B ter of the French Tax Code. In this respect, the Offering constitutes an eligible reinvestment for maintaining the deferral of the capital gain on the contribution, with respect to the nature of the reinvestment.

The other conditions for application of the regime that are independent of the Company, including the reinvestment period and threshold, the holding of the new securities, and other applicable requirements, must also be complied with by the subscriber. Investors who may be eligible for this regime are invited to consult their usual tax adviser in order to assess their personal situation in light of the specific applicable regulations.

Risk factors

The main risk factors relating specifically to the Offering are set out below:

Shareholders not participating in the Offering will see their shareholding in the Company diluted by the issuance of the New Shares, and would see their shareholding diluted by any future capital increases made necessary by the Company’s ongoing openness to fundraising;
The market price of the Company’s shares may fluctuate and fall below the subscription price of the New Shares;
The volatility and liquidity of the Company’s shares may fluctuate significantly;
The other risk factors relating to the Company and its activities set out in the section "P Specific risk factors" of its 2025 annual financial report and of the information document, available on the Company’s website.

(Press release, MEDIAN Technologies, JUN 3, 2026, View Source [SID1234666421])

Verastem Oncology Announces U.S. FDA Fast Track Designation for VS-7375, an Oral and Potential Best-in-Class Investigational KRAS G12D (ON/OFF) Inhibitor for the Treatment of KRAS G12D-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

On June 3, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to VS-7375, an oral and potential best-in-class investigational selective KRAS G12D (ON/OFF) inhibitor, for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially. FDA Fast Track Designation was previously granted for VS-7375 for the treatment of KRAS G12D-mutated advanced or metastatic pancreatic cancer.

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"Non-small cell lung cancer is the most prevalent lung disease with more than 8,000 patients in the U.S. diagnosed each year with KRAS G12D-mutations. Receiving Fast Track designation for VS-7375 reinforces both the significant unmet need and the potential of VS-7375 to improve outcomes for patients with KRAS G12D-mutated lung cancer," said Michael Kauffman, M.D., Ph.D., president of development at Verastem Oncology. "We are continuing to accelerate the development of VS-7375 across multiple KRAS G12D-driven tumor types, including pancreatic, non-small cell lung, and colorectal cancers to bring a highly targeted, oral treatment option to patients as quickly as possible."

Non-small cell lung cancer (NSCLC) is the most prevalent type of lung cancer, accounting for approximately 80% to 85% of all cases. The majority of patients with NSCLC are diagnosed with advanced-stage disease, either locally advanced (30% to 35%) or metastatic (50% to 55%), which is inoperable. The KRAS G12D mutation occurs in five percent of NSCLC cases and patients with these mutations are known to have reduced responses to standard therapies and poor prognosis. Currently, no therapies are approved by the FDA specifically targeting KRAS G12D mutations in cancer.

TARGET-D 202 is a Phase 2, open-label, multi-center study to evaluate VS-7375 900 mg oral dose once daily (QD) in patients with advanced NSCLC who have received one to two prior lines of therapy. Based on positive data in pre-clinical intracranial tumor models, the study is also evaluating VS-7375 in NSCLC patients with asymptomatic untreated brain metastases.

In June 2025, Verastem initiated TARGET-D 101, its Phase 1/2 dose escalation, dose expansion and combination clinical trial evaluating VS-7375 in patients with advanced KRAS G12D-mutated solid tumors, including pancreatic, non-small cell lung, and colorectal cancers. Enrollment is ongoing with monotherapy dose escalation progressing from 400 mg through 900 mg once daily (QD) doses without dose-limiting toxicities or major safety concerns observed to date. The study is currently evaluating a 1200 mg QD monotherapy dose and a 900 mg QD cetuximab combination cohort.

In the ongoing TARGET-D 101 study, data reported in March 2026 from 23 patients treated across the 400 mg, 600 mg and 900 mg QD dose levels, with a mean treatment duration of 1.6 months (range 0.7–5.6), showed VS-7375 was generally well tolerated, with no drug-related liver function test abnormalities or Grade >2 neutropenia observed as of the January 30, 2026 data cutoff, and lower reported rates of nausea, vomiting and diarrhea compared with data previously reported in China. Following feedback from the FDA, Verastem has further expanded the VS-7375 clinical program with the initiation of three Phase 2 registration-directed trials: TARGET-D 201 in metastatic pancreatic ductal adenocarcinoma, TARGET-D 202 in advanced non-small cell lung cancer, and TARGET-D 203 in metastatic colorectal cancer.

About KRAS G12D

KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. The KRAS G12D mutation occurs most commonly in pancreatic (37%), colorectal (12.5%), endometrial (8%), biliary tract (7-15%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration (FDA) specifically targeting KRAS G12D mutations in cancer.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor

VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. The mechanism of action of VS-7375 is unique in that it binds the active (ON) and inactive (OFF) states of KRAS G12D, with the potential to inhibit KRAS G12D signaling and tumor growth more completely than compounds that block KRAS G12D only in the OFF state or only in the ON state.

In June 2025, Verastem initiated TARGET-D 101, a Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. Verastem has further expanded the VS-7375 clinical program with the initiation of three Phase 2 registration-directed, open-label clinical trials: TARGET-D 201 in second-line advanced or metastatic pancreatic ductal carcinoma, TARGET-D 202 in second/third-line advanced or metastatic non-small cell lung cancer, and TARGET-D 203 in metastatic colorectal cancer.

In July 2025, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic pancreatic ductal carcinoma who have received at least one prior line of standard systemic therapy.

In December 2023, Verastem selected VS-7375 as its lead program from its collaboration with GenFleet Therapeutics, which aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. In January 2025, Verastem exercised its license for VS-7375. The licenses would give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan. GenFleet is developing VS-7375 as GFH375 in China.

(Press release, Verastem, JUN 3, 2026, View Source [SID1234666420])

Taiho Oncology Announces New England Journal of Medicine Publication of First All-Oral Regimen in Newly Diagnosed Acute Myeloid Leukemia

On June 3, 2026 Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, reported the publication in the New England Journal of Medicine of results from the ASCERTAIN-V Phase 1/2 clinical trial, which evaluated the first all-oral regimen of decitabine-cedazuridine plus venetoclax in patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy. The study demonstrated favorable response rates and survival with expected myelosuppressive effects.1

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Previously presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting and the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, the results suggest this first all-oral regimen may provide outcomes consistent with existing hypomethylating agent–venetoclax–based approaches for patients with newly diagnosed AML who cannot receive intensive induction therapy.

Nearly 23,000 people in the U.S. are expected to be diagnosed with AML, a cancer of the blood and bone marrow, in 2026. 2 More than half of those patients will likely be deemed ineligible for intensive induction chemotherapy because of factors such as older age (75 or older) or poor health. 3 For these patients, the standard treatment often combines oral venetoclax with parenteral hypomethylating agents, requiring frequent injections or infusions and an average of 12.9 days per month engaging in healthcare visits. 4

Oral decitabine-cedazuridine is a hypomethylating agent that has demonstrated oral bioavailability and equivalent pharmacokinetic exposure to intravenous decitabine. 5

"We are committed to advancing therapies that improve the lives of patients, their families and their caregivers," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "An all-oral regimen for AML could help reduce the significant time and cost burden associated with treatment in hospitals or infusion centers."

The ASCERTAIN-V trial evaluated the first all-oral regimen of oral decitabine-cedazuridine plus venetoclax in 189 patients (Phase 1, n=30; Phase 2a, n=58; Phase 2b, n=101). After an initial ramp-up period, patients were treated in 28-day cycles, receiving decitabine-cedazuridine on days one through five and venetoclax daily. Key results include complete response rates, durable remissions and survival, and a safety profile consistent with hypomethylating agent-venetoclax regimens.

In the Phase 2b of ASCERTAIN-V:
The complete response rate was achieved in 47% of patients (95% CI: 36-57%). The composite of complete response or complete response with incomplete hematologic recovery was 63% (95% CI: 53-73%).
The median time to marrow blasts of less than 5% was 28 days (range 22 to 57), and the median time to a complete response or complete response with incomplete hematologic recovery was 35 days (range 27 to 58).
Among patients achieving complete response, 80% (95% CI: 64%, 90%) had an ongoing response at six months and 75% (95% CI: 57%, 87%) at 12 months.
Median overall survival was 15.5 months (95% CI 7.6-not estimable). The 30- and 60-day mortality rates were 3% and 10%, respectively. The median follow-up period was 11.2 months.
Serious adverse events were reported in 84% of patients, consistent with known hypomethylating agent–venetoclax regimens. Common related Grade ≥3 adverse events were anemia (30%), neutropenia (26%) and febrile neutropenia (25%).

No drug–drug interactions were observed between decitabine-cedazuridine and venetoclax.
In the Phase 2b of ASCERTAIN-V, decitabine-cedazuridine and venetoclax dosing was modified once leukemic blast clearance was achieved as measured by bone marrow morphology assessments. Serious adverse events and febrile neutropenia decreased as venetoclax dosing days decreased with each treatment cycle. This information potentially supports the need to explore a treatment strategy of an initial induction followed by dose-adjusting ongoing cycles to enhance tolerability and minimize cytopenia-related complications in patients who have reached remission.

"The positive results of the trial — response rates, safety, pharmacokinetics and tolerability data — suggest that an all-oral regimen could potentially become a meaningful alternative to existing treatment protocols that involve parenteral hypomethylating agents for patients with AML who can’t undergo intensive induction chemotherapy," said Gail J. Roboz, M.D., the paper’s lead author, a professor of medicine, director of the Clinical and Translational Leukemia Program and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and a hematologist oncologist at NewYork-Presbyterian/Weill Cornell Medical Center in New York City. "An all-oral treatment regimen is a highly anticipated addition to current treatment options for patients with AML."

About Decitabine and Cedazuridine Fixed-Dose Combination
This product is an orally administered, fixed dose combination of the approved anti-cancer DNA hypomethylating agent, decitabine, together with cedazuridine,6 an inhibitor of cytidine deaminase.7 By inhibiting cytidine deaminase in the gut and the liver, the fixed dose combination is designed to allow for oral delivery of decitabine over five days in a given cycle to achieve comparable systemic exposure to IV decitabine administered over five days.

(Press release, Taiho, JUN 3, 2026, View Source [SID1234666419])

ADC Therapeutics Announces Results From LOTIS-5 Phase 3 Confirmatory Clinical Trial of ZYNLONTA® in Combination with Rituximab in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

On June 3, 2026 ADC Therapeutics SA (NYSE: ADCT) reported topline data from its Phase 3 LOTIS-5 confirmatory trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). ZYNLONTA plus rituximab achieved statistical significance on the trial’s primary endpoint of progression-free survival (PFS) and demonstrated no detrimental effect on the key secondary efficacy endpoint of overall survival (OS). In addition, a higher complete response (CR) rate and duration of CRs (DoCR) were observed with ZYNLONTA plus rituximab. Overall, treatment emergent adverse event (TEAE) rates were similar between arms. Similar rates of overall Grade ≥3 TEAEs greater than 5% were observed across both arms, with hematologic TEAEs higher in the control arm and infection, hepatotoxicity, and edema/effusion higher in the test arm. Serious adverse events (SAEs), TEAEs leading to study drug withdrawal, and Grade 5 events were higher in the test arm, with the majority of Grade 5 TEAEs in the test arm occurring in patients aged 75 years or older.

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"In the context of a positive study, based on the totality of the data, we plan to discuss the benefit-risk profile of this combination with the U.S. FDA as we prepare for the planned supplemental Biologics License Application (sBLA) filing," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We would like to extend our thanks to the patients, investigators, and clinical teams who contributed to this important trial."

The LOTIS-5 trial is a randomized, open‐label, two‐arm, multicenter study evaluating ZYNLONTA plus rituximab versus the standard immunochemotherapy rituximab gemcitabine‐oxaliplatin (R‐GemOx), for the treatment of r/r DLBCL after one or more lines of systemic therapy. The study met the primary endpoint of PFS (per independent review committee) with statistical significance (HR = 0.73; p-value = 0.008 two sided), with a median PFS of 6.1 months for ZYNLONTA plus rituximab vs 4.7 months for R-GemOx. Overall survival showed no detrimental effect with ZYNLONTA plus rituximab compared to the control arm (HR = 0.96, impacted by the earlier use and a higher rate of new anti-lymphoma treatment switching in the control arm). Overall response rate (ORR) was 58.1% vs. 45.2%, CR rate was 39.5% vs. 26.7%, median duration of response (DOR) was 9.2 months vs. 7.7 months, and median DoCR was 16.8 months vs. 12.3 months for ZYNLONTA plus rituximab compared to R-GemOx, respectively. Of patients achieving CR, 48.5% vs. 16.7% remained in CR at 24 months in favor of ZYNLONTA plus rituximab. Of note, results in North America were consistent with the overall study results.

Overall, TEAE rates were similar between arms (98.5% vs. 97.5%). Higher rates of SAEs were seen in the test arm (49.0% vs. 34.5%). Grade ≥3 TEAEs observed in > 5% of patients were hematologic (40.7% vs. 59.4%), followed by infection/infestations (24.5% vs. 15.7%), then hepatotoxicity (17.2% vs. 8.1%) and oedema/effusion (7.4% vs. 0.5%) when comparing ZYNLONTA plus rituximab to R-GemOx. A higher rate of Grade 5 TEAEs was observed in the ZYNLONTA plus rituximab arm (27 pts/13.2%) vs. R-GemOx (9 pts/4.6%). Of note, the majority of Grade 5 TEAEs in the test arm occurred in patients aged 75 years or older. Higher rates of TEAEs leading to any drug withdrawal occurred in the ZYNLONTA plus rituximab arm (25.5% vs. 9.1%). In this study, the TEAE reporting window was defined as 105 days after the last dose of study treatment or the start of new anticancer therapy, whichever is earlier. The rates of TEAEs in this study were impacted by the longer overall TEAE observation time in the test vs. control arm. This difference is primarily driven by a higher rate of and earlier switching to subsequent therapies in the control arm.

"LOTIS-5 was designed to address a clear unmet need in r/r DLBCL in patients who cannot access or who progress on a CAR-T or other complex therapies," said Mehdi Hamadani, MD, Professor of Medicine, Associate Director of Clinical Research, Section Chief of Hematologic Malignancies at Medical College of Wisconsin and principal investigator for the trial. "Based on these results, I believe this combination may provide an additional option in treating relapsed or refractory DLBCL."

"Based on these topline results from LOTIS-5, we look forward to discussing next steps for this combination of ZYNLONTA plus rituximab with the U.S. FDA," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "We intend to conduct a pre-sBLA meeting in August and are preparing for a planned sBLA submission in the fourth quarter of 2026."

In addition, the Company will continue to evaluate a broad range of value maximizing alternatives, including but not limited to near-term cost reduction initiatives.

For more information about LOTIS-5, please visit View Source (identifier: NCT04384484).

Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss the LOTIS-5 results today at 4:30 p.m. EDT. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

(Press release, ADC Therapeutics, JUN 3, 2026, View Source [SID1234666418])

Ingenix Raises €13m From Sofinnova Partners-Led Syndicate to Scale Modality Fusion, a Novel Architecture for Drug Development

On June 3, 2026 Ingenix, the AI and biology company built around a single question – "What would it take for AI to truly understand biology?" – reported a €13m seed-extension funding round led by Sofinnova Partners, with participation from Inovo VC and OTB VC.

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The funding will scale development of Ingenix’s Biological Reasoning Engine and broaden its work with pharma and biotech partners through the Qualified Access Program, launching today.

The dominant approach in AI for drug development, which trains larger models on larger datasets assuming biology will yield to scale, faces a structural problem. Biology is profoundly complex, fundamentally non-linguistic, and runs across modalities and biological scales. No single model, however large, can capture that on its own. Moreover, no single company holds all the data, across every modality and biological scale, to train one. Ingenix has built a different architecture, Modality Fusion, which integrates best-in-class models across modalities and biological scales, then reasons across their representations directly. The Biological Reasoning Engine is what Modality Fusion enables.

"This funding lets us extend the Biological Reasoning Engine to the partners and questions where it can do the most useful work," said Piotr Surma, CEO and co-founder of Ingenix. "We built Ingenix on the conviction that biology needs an AI architecture designed for biology and not a general-purpose model retrofitted to it. The early results have been stronger than we forecast, and we’re excited to extend the Engine to a select number of partners through the Qualified Access Program."

"It is no longer enough to just build models," added Simon Turner, Partner at Sofinnova Partners. "Ingenix is building the reasoning layer, the part that actually connects the biology, the chemistry, and the clinical data into something a scientist can interrogate and act on. That’s the hard bit, and that’s where the value compounds. We’re thrilled to back a team that gets that."

The Engine in Action: ADC Payload Prioritization

In a recent engagement, Ingenix applied its Biological Reasoning Engine to a dual-payload ADC prioritization problem for an oncology biotech which had thousands of possible payload configurations but lacked the experimental capacity to test them.

The Engine produced 15 candidate combinations. Under blind expert review by the biotech’s translational science team, the predictions broke down as follows:

5 were publicly known hypotheses.
2 were supported in existing literature but not widely cited.
3 had been confirmed by the biotech through internal experiments but never published and never disclosed to Ingenix.
5 were novel hypotheses not previously considered by the biotech team. Of these, the biotech flagged 3 as actionable candidates.
The double-payload ADC space is too new for any AI system to have seen meaningful training data on it. The engine reached its predictions by reasoning from first principles about the underlying biology, rather than by pattern-matching against prior examples.

In short, insights that had taken the biotech several years of research and millions of euros to develop were accomplished by the Engine in a matter of minutes.

Applications to the Qualified Access Program are now open at ingenix.ai/qap.

(Press release, Ingenix, JUN 3, 2026, View Source [SID1234666417])