On August 26, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported early findings from the first five recurrent glioblastoma patients treated with its investigational immune-boosting regimen including ANKTIVA (nogapendekin alfa inbakicept-pmln) in this pilot study (NCT06061809) (Press release, ImmunityBio, AUG 26, 2025, View Source [SID1234655480]). All five patients achieved 100% disease control with the regimen that combines ANKTIVA, an IL-15 agonist being studied for its ability to enhance natural killer (NK) cell activity, NK cell therapy (PD-L1 t-haNK), and Optune Gio Tumor Treating Fields. Of the 5 patients treated to date, 3 responded of which 2 at near complete response and the remaining 2 having stable disease to date. This finding of 5 out of 5 (100%) disease control in 2nd line recurrent glioblastoma receiving a chemotherapy free immunotherapy with Optune immune stimulating device is highly encouraging.

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We believe these early results of this combination immune-stimulating therapy are notable, given both the fact that GBM is a common form of brain tumor, as well as one that is exceptionally difficult to treat successfully with currently approved therapies. GBM has a single digit five-year survival rate for patients aged 45 and over. While the initial treatments in this trial involve a small cohort, the results are sufficiently encouraging for the company to plan a Phase 2 trial in second-line glioblastoma to further evaluate the potential for this combination treatment.

"GBM is a devastating type of brain cancer for which there are currently no durable treatment options, which is why this study has such important potential," said Dr. Simon Khagi, Medical Director of Neuro-Oncology at the Hoag Family Cancer Institute, and the Principal Investigator for this study. "In my years of treating patients with glioblastoma I have never experienced these near complete responses as well as the rapidity of the response as seen in these patients to date," he further stated. "There has been little advance in therapy for decades for glioblastoma. This chemotherapy free, immune-stimulating combination approach with ANKTIVA is highly promising and may represent a fundamental advance in therapy in patients with tumors of the brain."

"Although they are early, these results are very encouraging, given the high risk and low survival rates associated with GBM," added Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "There is compelling evidence that ANKTIVA’s mechanism of proliferating NK and T cells plays an important role in treating patients with cancer Independent of tumor type. By activating the immune system the goal of providing durable responses is at hand. We believe these preliminary results in patients with GBM, whose lymphocyte counts (NK and T cells) are low as a consequence of radiation and chemotherapy after first-line treatment, can be rescued following ANKTIVA and NK cell therapy, and warrant the rapid expansion of this study in recurrent glioblastoma."

To learn more about this glioblastoma trial visit clinicaltrials.gov/study/NCT06061809 and cssifm.org

ANKTIVA, which is approved by the U.S. Food and Drug Administration with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, is being evaluated alone and with other agents in multiple studies for non-small cell lung cancer, non-Hodgkin lymphoma, Lynch syndrome (hereditary colon cancer), ovarian cancer and Human Papillomavirus (HPV) associated tumors. ANKTIVA is also being studied in Human Immunodeficiency Virus (HIV) and lymphopenia.

To learn more about ImmunityBio’s clinical trials, visit immunitybio.com/find-a-trial/ and cssifm.org.

Optune Gio is a registered trademark of Novocure GmbH.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Prescribing Information for ANKTIVA at Anktiva.com.

On August 26, 2025 Genmab A/S (Nasdaq: GMAB) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-directed, TOPO1-inhibitor antibody-drug conjugate (ADC), for the treatment of adult patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy (Press release, Genmab, AUG 26, 2025, View Source [SID1234655479]). BTD aims to expedite the development and review of investigational medicines by the U.S. FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies.

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The designation was supported by previously published results from the endometrial cancer monotherapy dose expansion B2 cohort of the multi-part, Phase 1/2 RAINFOL-01 trial (NCT05579366), evaluating the safety and efficacy of Rina-S in solid tumors. In the B2 cohort, 64 patients with heavily pretreated advanced or recurrent EC whose disease had progressed on or after an anti-PD-(L)1 and platinum-based chemotherapy were enrolled and treated with Rina-S. The results were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"This Breakthrough Therapy Designation underscores the future potential of Rina-S as a treatment option for women diagnosed with advanced endometrial cancer, who face a poor prognosis after progressing on standard of care treatment," said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer of Genmab. "Rina-S reinforces Genmab’s determination to advance wholly owned antibody medicines in areas long overdue for innovation and our commitment to driving a strong clinical development program to help redefine what’s possible to treat gynecologic cancers."

Rina-S is advancing through late-stage development supported by a growing portfolio of clinical trials, including the ongoing Phase 1/2 RAINFOL-01 trial, the ongoing Phase 3 RAINFOL-02 trial (NCT06619236) in ovarian cancer, and several planned trials to evaluate Rina-S as a potential treatment option for a variety of tumor types, including a Phase 3 trial in endometrial cancer.

About the RAINFOLTM -01 Trial
RAINFOL-01 (NCT05579366) is an open-label, multicenter Phase 1/2 study, designed to evaluate the safety and efficacy of rinatabart sesutecan (Rina-S) Q3W at various doses in solid tumors that are known to express FRα. The study consists of multiple parts including Part A dose escalation; Part B tumor-specific monotherapy dose-expansion cohorts; Part C platinum-resistant ovarian cancer (PROC) cohort; Part D combination therapy cohorts; Part F a monotherapy endometrial cancer (EC) cohort; and Part K monotherapy QTc cohort in high-grade ovarian cancer.

About Endometrial Cancer
Endometrial cancer (EC) starts in the lining of the uterus, known as the endometriumii and ranks as the second most prevalent gynecologic cancer globally, with increasing incidence and mortality ratesiii,iv. Patients with advanced or recurrent EC have a relatively poor prognosis and treatment options are limited for those patients who have progressed following treatment with chemotherapy and immune checkpoint inhibitor. FRα is overexpressed on multiple tumors, including EC, making it a promising therapeutic target. Anti-tumor activity with Rina-S was observed across a broad range of FRα expression, and there are currently no approved FRα-directed therapies approved for the treatment of endometrial cancer.

About Rinatabart Sesutecan (Rina-S; GEN1184)
Rinatabart sesutecan (Rina-S; GEN1184) is an investigational ADC. It is composed of a novel human monoclonal antibody directed at folate receptor α (FRα), a novel hydrophilic protease-cleavable linker, and exatecan, a topoisomerase I inhibitor payload. The clinical trial program for Rina-S continues to expand including ovarian, endometrial and other cancers of unmet need.

The safety and efficacy of rinatabart sesutecan has not been established. Please visit www.clinicaltrials.gov for more information.

On August 26, 2025 Genmab A/S (Nasdaq: GMAB) reported that its Chief Executive Officer Jan Van de Winkel and Chief Financial Officer Anthony Pagano will participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference in New York City, NY at 7:45 AM EDT (1:45 PM CEST) on September 9, 2025 (Press release, Genmab, AUG 26, 2025, View Source [SID1234655478]). A webcast of the fireside chat will be available on Genmab’s website at View Source

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On August 25, 2025 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases, reported that financial capacity will be improved through a new fund raise of €500,000 following on the May 2025 fundraise of €1.7M (Press release, TME Pharma, AUG 25, 2025, View Source [SID1234655476]). The improved financial situation should strengthen TME Pharma’s position in discussions with financial and strategic partners. It would also enable the Company to prepare for the future investments recently communicated by TME Pharma and about which the Company will continue to inform shareholders.

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"I’m pleased to feel the renewed support from our shareholders and investors for the newly adopted strategy. While we see many companies struggling to secure financing, TME Pharma is continuing to take important steps to increase its financial strength," said Diede van den Ouden, CEO of TME Pharma. "Because we now have lower operating costs due to the shift to an outsourcing model earlier this year, we can use proceeds of financing directly to fund TME Pharma’s projects. I’m excited about this development, and with this additional financing, I’m confident that we can achieve important progress with TME Pharma."

TME Pharma is intending on increasing its financial capacity through the issuance of regular debt via private contractual agreements with European investors (Investor) in exchange for €500,000 in cash. The bonds will be issued on August 28, 2025 at 85.4% of nominal value and repaid by the Company in cash at maturity at 93.5% of nominal value. Closing date for receipt of cash by the Company is August 28, 2025, on which date the bonds and warrants will be issued. Under this bond issuance, 6,387,055 private, non-tradable warrants will be attached to the bonds, giving the holders the right to subscribe for one common share in TME Pharma for each warrant, subject to adjustment of the number of shares as described below, with an exercise price of €0.11 per warrant, which is a 2,12% premium to the volume weighted average share price (VWAP) for the 10 days preceding the initial announcement of this bond issuance made on August 25, 2025.

In recent months, TME Pharma has implemented measures to drastically reduce costs (starting on July 1, 2025), while preserving the Company’s main assets. This transaction aims to increase financial runway while limiting near-term dilution potential for existing shareholders by using debt repayable in cash. While the warrants issued in the transaction have dilutive potential, their exercise price is above the current share price. If all warrants are exercised, the warrant exercise will bring the Company an additional €702,576 in cash. The proceeds from this financing will support TME Pharma’s research and development activities and its recently announced treasury investment strategy and the search for the potential acquisitions and partnerships in profitable businesses. Along with an analysis of TME Pharma’s tax carry forward losses, the Company is continuing to work to creating a fundamentally profitable corporate structure in which revenues from non-core activities will support and strengthen the further development of its patented drug candidates, which remain the company’s flagship products, NOX A12 and NOX-E36.

TME Pharma will inform shareholders if significant developments occur.

Description of the August 28, 2025 debt issuance

Designation

Subscription Price Paid for Bonds

Amount to be Reimbursed by TME Pharma in Cash at Maturity

Nominal Amount of Bonds

% of Total Debt to be Issued

Warrants attached to bonds
No. to be Issued

Cash to be received upon full warrant exercise

% of Total Warrants to be issued

Total Transaction

500,000.00 €

547,423.90 €

585,480.10 €

100.0%

6,387,055

€702,576

100.0%

Including participation by the following TME Pharma Management Board executives and Supervisory Board members as indicated below:

Mr. Diede van den Ouden (CEO/Management Board)

22,956.00 €

25,132.89 €

26,827.87 €

4.58%

292,667

€32,193

4.59%

Dr. Maurizio PetitBon (Chairman of Supervisory Board)

50,044.00 €

54,791.00 €

58,600.00 €

10.01%

639,272

€70.320

10,01%

Details of the debt and non-tradable warrants issued via individual private agreements with Investors:

Debt:

The debt is purchased at discount to nominal value of 85.4% and repaid at maturity in cash at 93.5% of nominal value. Closing date for receipt of cash by the company is August 28, 2025, on which date the debt and warrants will be issued.
Maturity of the debt is 9 months from the issuance date, August 28, 2025.
TME Pharma has the right to reimburse in cash any outstanding loan amount early. In such cases, a lower percentage of the nominal value will be paid, determined by the number of months remaining before maturity of the debt at between 83.7% and 93.5% of the nominal value, according to table below:
Number of whole months remaining prior to maturity of debt when loan amount reimbursed in cash

(dates when this applies)

8

(Aug 28 – Sept 27 2025)

7

(Sept 28 – Oct 27 2025)

6

(Oct 28 – Nov 27 2025)

5

(Nov 28 – Dec 27 2025)

4

(Dec 28 2025 – Jan 27 2026)

3

(Jan 28 – Feb 27 2026)

2

(Feb 28 – Mar 27 2026)

1

(Mar 28 – Apr 27 2026)

0 and at Maturity

(Apr 28 2026 to Maturity)

Percentage of loan amount to be reimbursed in cash to fully extinguish debt obligation

86.3 %

87.2 %

88.1 %

89 %

89.9 %

90.8 %

91.7 %

92.6 %

93.5 %

The debt amount shall constitute direct, unconditional, unsubordinated and unsecured obligations of TME Pharma, ranking equally between the lenders and (with the exception of the mandatory provisions of Dutch law) equally with all other present or future unsubordinated and unsecured obligations (with the exception of those benefiting from a preference in accordance with the law) of the issuer.
If the Company conducts a capital increase by issuance of new shares, the debt holders will be given the opportunity to participate on equal conditions to other investors in the capital increase. The payment for shares is then settled against a percentage of the value of the debt the Company owes to the debt holder according to the following table:
Number of whole months remaining prior to maturity of debt when loan amount contributed to capital increase (dates when this applies)

8

(Aug 28 – Sept 27 2025)

7

(Sept 28 – Oct 27 2025)

6

(Oct 28 – Nov 27 2025)

5

(Nov 28 – Dec 27 2025)

4

(Dec 28 2025 – Jan 27 2026)

3

(Jan 28 – Feb 27 2026)

2

(Feb 28 – Mar 27 2026)

1

(Mar 28 – Apr 27 2026)

0 and at Maturity

(Apr 28 2026 to Maturity)

Percentage of loan amount to be settled for shares to fully extinguish debt obligation

92%

93%

94%

95%

96%

97%

98%

99%

100%

Warrants:

The amount of warrants issued is based on the nominal value of the total amount of bonds issued, multiplied by 1.20. The exercise price is €0.11, with maturity of 21 months from August 28, 2025. This transaction will thus result in the issuance of 6,387,055 warrants. This could lead to the issuance of 6,387,055 shares if all warrants are exercised, with proceeds for the Company worth €702,576.11, subject to adjustment as set forth below.
If subsequent to issuance of these warrants, the Company conducts a financing operation of >€1.5 million resulting in issuance of shares or giving rights to purchase shares at a price per share below €0.11 (the "Qualifying Financing"), this will trigger an adjustment to the number of shares issued on exercise of each warrant. This adjustment will result in additional shares being issued upon exercise of the warrant to effectively adjust the price per share paid upon exercise to a 20% premium above the price paid in the Qualifying Financing triggering the adjustment. For example, if a capital raise were to be conducted at €0.08 per share and warrants worth €10,000 were exercised, then 104,167 ordinary shares would be issued instead of 100,000 and the effective price per share once warrants are exercised would become €0.096. The number of shares to be issued upon the exercise of each warrant is calculated using the following formula:
warrant exercise price (always €0.11)
Number of warrants issued 6,387,055
Number of shares issued on warrant exercise: (a) if no Qualifying Financing has occurred, then 1 share per warrant; and (b) subsequent to the occurrence of a Qualifying Financing, the number of shares to be issued per warrant is the result of the following calculation: €0.11 divided by the price per share paid in the context of the Qualifying Financing divided by 1.2 ((a) an d (b) together the "Warrant Exercise Ratio")
For the purposes of calculating this formula,
Price per share in the context of the Qualifying Financing shall mean, in any Qualifying Financing, the consideration paid to acquire one ordinary share in the context of such Qualifying Financing.
Such adjustment shall become effective on the date of issue of such shares in a Qualifying Financing.
The Warrant Exercise Ratio shall be rounded to 4 digits after the decimal place for calculation of the number of shares per warrant.
No partial shares can be issued, any fractions shall be rounded down and ordinary shares may never be issued at below their nominal value, currently €0.01.
No adjustment shall be made if the Warrant Exercise Ratio obtained with the above calculation is lower than the Warrant Exercise Ratio in force prior to the transaction.
By way of example: if shares are issued under a Qualifying Transaction at 0.08 per share, then the calculation would be as follows:

Warrant Exercise Ratio prior to Qualifying Transaction: 1
New Warrant Exercise Ratio after Qualifying Transaction: €0.11/€0.08/1.2 = 1.14583
Exercise of 100,000 warrants would then result in the issuance of 114.583 shares for an aggregate exercise price of €11,000, or a price per share of €0.0960 per share, a 20% premium to the price per ordinary share paid in the Qualifying Transaction.
A minimum number of 100,000 warrants must be exercised at each exercise, which would result in payment of €11,000 to the company for exercise (100,000 warrants exercised * €0.11 exercise price = €11,000)

A tracking table of the outstanding debt and warrants will be available on the company’s website as of the issuance date, August 28, 2025.

Shareholder and Corporate Authorizations
The issuance of the warrants giving the right to subscribe for the same number of ordinary this transaction is carried out in accordance with Dutch law and relies upon the delegation of authority to issue shares and rights to subscribe for shares granted to the company’s board of directors by its shareholders in the annual general meeting (AGM) on June 25, 2025. The Company has completed and obtained all necessary corporate approvals for this transaction.

Dilutive Potential
The table below summarizes the dilution from the new ordinary shares that would be issued upon exercise of all of the private, non-tradable warrants to be issued under this transaction, assuming no adjustment to the number of shares issued per warrant is required.

Description

Shares to be issued

Total shares outstanding

Dilution (cumulative)

Shareholder starting with 1% on 21 August 2025, would then hold

Outstanding shares on 21 August 2025

–

94,188,981

–

–

Shares issued from exercise of 17,056,000 private, non-tradable warrants, latest on May 27, 2027

17,056,000

111,244,981

15.33%

0.85%

Shares issued from exercise of 6.387.055 private, non-tradable warrants, latest on August 27, 2027

6,387,055

117,632,036

19,93%

0.80%

Investors may familiarise themselves with the risks described in the Company’s 2024 annual financial report (LINK) available on the company website.

On August 25, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR) reported that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, reported it will participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on Tuesday, September 9 at 1:05 p.m. PT / 4:05 p.m. ET in New York, New York (Press release, Vir Biotechnology, AUG 25, 2025, View Source [SID1234655475]).

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A live webcast of the fireside chat will be made available under Events & Presentations in the Investors section of the Vir Biotechnology website and will be archived for 30 days.