On August 11, 2025 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported financial results for the second quarter ended June 30, 2025 and highlighted progress on key clinical development programs (Press release, Karyopharm, AUG 11, 2025, View Source [SID1234655071]).

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"As we continue to seek potential financing and strategic alternatives to extend our cash runway and enhance liquidity, I am excited to announce that we are in our final weeks of enrolling our Phase 3 SENTRY trial and are on track to report top-line data from this pivotal trial in March 2026," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Over the past seven years, we have led the development of a growing body of evidence supporting the role of XPO1 inhibition in myelofibrosis and are optimistic about selinexor’s potential in this disease. Completing enrollment is a very important step in our journey to potentially redefine the standard-of-care in myelofibrosis and provide a transformational opportunity for patients and our organization, pending positive data."

Second Quarter 2025 Highlights

XPOVIO Commercial Performance

U.S. net product revenue was $29.7 million in the second quarter of 2025 compared to $28.0 million in the second quarter of 2024.
Demand for XPOVIO was consistent in the second quarter of 2025 compared to the second quarter of 2024, with the community setting continuing to drive approximately 60% of overall net product revenue.
Expanded global patient access for selinexor is translating into growth in royalty revenue from Menarini, Antengene and other international partners. Royalty revenue increased 28% to $1.6 million in the second quarter of 2025 compared to the second quarter of 2024.
Research and Development (R&D) Highlights

Myelofibrosis

The Phase 3 SENTRY trial (XPORT-MF-034; NCT04562389) is nearing full enrollment and the Company expects new patient screening will be closed this week. SENTRY is targeting 350 patients for enrollment and is evaluating 60 mg once-weekly selinexor in combination with ruxolitinib compared to ruxolitinib plus placebo. The preliminary baseline characteristics for patients enrolled in SENTRY are representative of the intended patient population. In addition, preliminary blinded aggregate safety data from the first 61 patients with a median follow-up of greater than 12 months may suggest improvements in both hematologic and non-hematologic treatment emergent adverse events as compared to the Phase 1 data evaluating selinexor 60 mg weekly in combination with standard of care ruxolitinib in JAKi-naïve myelofibrosis patients, as well as historical ruxolitinib monotherapy data. The Company cautions that the preliminary baseline characteristics and preliminary blinded aggregate safety data may not be reflective of the actual top-line data.
Presented data from the XPORT-MF-035 (NCT04562870) Phase 2, randomized, open-label trial of selinexor versus physician’s-choice in hard-to-treat patients with heavily pretreated myelofibrosis (N=24) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress. The data suggest the potential for single-agent clinical activity with selinexor, including spleen volume reduction, symptom improvement, hemoglobin stabilization, and evidence of disease modification. A copy of the poster that was presented at EHA (Free EHA Whitepaper), titled "A Study to Evaluate Single-Agent Selinexor Versus Physician’s Choice in Participants With Previously Treated Myelofibrosis" is available under "Publications and Presentations" in the Investor section of the Company’s website.
The Company continues to enroll JAKi-naïve myelofibrosis patients with moderate thrombocytopenia (defined as having platelet counts between 50,000 and 100,000) in the selinexor 60 mg cohort of the Phase 2 SENTRY-2 trial (XPORT-MF-044; NCT05980806). The Company plans to amend the protocol for SENTRY-2 to also include patients with platelet counts above 100,000, which will expand the number of patients that are eligible to participate in the trial. Approximately 10% to 15% of patients with myelofibrosis have platelet counts between 50,000 and 100,0001. The Company expects to report top-line data from all patients in the 60 mg cohort with at least 24 weeks of follow-up in 2026.
1 Tremblay et al. Thrombocytopenia in Patients With Myelofibrosis: A Practical Management Guide, Clinical Lymphoma Myeloma and Leukemia Vol 22 Dec 2022

Endometrial Cancer

Enrollment continues in the Phase 3 XPORT-EC-042 (NCT05611931) trial evaluating selinexor as a maintenance-only therapy following systemic therapy versus placebo in patients with TP53 wild-type advanced or recurrent endometrial cancer.
Multiple Myeloma

Enrollment of approximately 120 patients in the Phase 3 XPORT-MM-031 trial (EMN29; NCT05028348) was completed in the fourth quarter of 2024. The trial is being conducted in collaboration with the European Myeloma Network and is evaluating the all-oral combination of selinexor 40 mg, pomalidomide and dexamethasone (SPd40) in patients with previously treated multiple myeloma who received an anti-CD38 in their immediate prior line of therapy.
Anticipated Catalysts and Operational Objectives

Myelofibrosis

The Company expects new patient screening will be closed for the Phase 3 SENTRY trial this week with top-line data expected in March 2026.
Multiple Myeloma

Maintain the Company’s commercial foundation in the increasingly competitive multiple myeloma marketplace and drive increased XPOVIO revenues.
Continue to support global launches by our partners following regulatory and reimbursement approvals for selinexor in ex-U.S. territories.
Continue to follow patients that are enrolled in the Phase 3 XPORT-MM-031 (EMN29) trial. The Company expects to report top-line data from this event-driven trial in the first half of 2026.
Endometrial Cancer

Continue to enroll patients into the Phase 3 XPORT-EC-042 trial of selinexor as a maintenance monotherapy for patients with TP53 wild-type advanced or recurrent endometrial cancer. The Company expects to report top-line data from this event-driven trial in mid-2026.
2025 Financial Outlook

Based on its current operating plans, Karyopharm expects the following for full year 2025:

Total revenue to be in the range of $140 million to $155 million. Total revenue consists of U.S. XPOVIO net product revenue and license, royalty and milestone revenue earned from partners.
U.S. XPOVIO net product revenue to be in the range of $110 million to $120 million.
R&D and selling, general and administrative (SG&A) expenses to be in the range of $240 million to $250 million.
The Company expects its existing liquidity, including the revenue it expects to generate from XPOVIO net product sales and its license agreements, will be sufficient to fund its planned operations to the maturity of its senior convertible notes due October 2025 (Remaining 2025 Notes). Excluding the $24.5 million Remaining 2025 Notes maturity and its $25.0 million minimum liquidity covenant, the Company expects it would have sufficient liquidity to fund planned operations into January 2026. The Company, with the assistance of its advisors, including its financial advisor Centerview Partners, is exploring potential financing and strategic alternatives to enhance liquidity and maximize value.
Second Quarter 2025 Financial Results

Total revenue: Total revenue for the second quarter of 2025 was $37.9 million, compared to $42.8 million for the second quarter of 2024.

Net product revenue: Net product revenue for the second quarter of 2025 was $29.7 million, compared to $28.0 million for the second quarter of 2024.

License and other revenue: License and other revenue for the second quarter of 2025 was $8.2 million, compared to $14.8 million for the second quarter of 2024. The decrease was primarily attributable to $6.0 million of non-recurring license-related revenue recognized during the second quarter of 2024.

Cost of sales: Cost of sales for the second quarter of 2025 was $1.1 million, compared to $1.5 million for the second quarter of 2024. Cost of sales reflects the costs of XPOVIO units sold and the costs of products sold to our partners.

R&D expenses: R&D expenses for the second quarter of 2025 were $32.8 million, compared to $38.4 million for the second quarter of 2024. The decrease was due to a reduction in personnel costs and stock-based compensation costs primarily due to a reduction in headcount and contractors, coupled with lower clinical trial and related costs due to the reduced scope of our Phase 3 multiple myeloma trial.

SG&A expenses: SG&A expenses for the second quarter of 2025 were $28.5 million, compared to $31.1 million for the second quarter of 2024. The decrease was primarily due to the realization of previously implemented cost reduction initiatives.

Interest income: Interest income for the second quarter of 2025 was $0.6 million, compared to $1.9 million for the second quarter of 2024. The decrease was due to a lower cash and investments balance quarter-over-quarter.

Interest expense: Interest expense for the second quarter of 2025 was $11.2 million, compared to $8.9 million for the second quarter of 2024. The increase was related to a full quarter of interest on the term loan and convertible debt that were issued in the second quarter of 2024.

Gain on Extinguishment of Debt and Other (expense) income: Other expense for the second quarter of 2025 was $2.2 million compared to $14.3 million of other income for the second quarter of 2024. The change is attributable to recurring non-cash fair value remeasurements related to the refinancing transactions that were completed in the second quarter of 2024. The refinancing transactions also resulted in a $44.7 million gain on extinguishment of debt during the second quarter of 2024.

Net (loss) income: Karyopharm reported a net loss of $37.3 million, or $4.32 net loss per basic and diluted share, for the second quarter of 2025, compared to net income of $23.8 million, or $2.26 net income per basic share and $2.97 net loss per diluted share, for the second quarter of 2024. Net (loss) income included non-cash stock-based compensation expense of $3.8 million and $5.4 million for the second quarters of 2025 and 2024, respectively.

Cash position: Cash, cash equivalents, restricted cash and investments as of June 30, 2025 totaled $52.0 million, compared to $109.1 million as of December 31, 2024.

Conference Call Information

Karyopharm will host a conference call today, August 11, 2025, at 8:00 a.m. Eastern Time, to discuss the second quarter 2025 financial results, the financial outlook for 2025 and to provide other business updates. To access the conference call, please dial (800) 836-8184 (local) or (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website. An archived webcast will be available on the Company’s website approximately two hours after the event.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in adult patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma; and (iii) under accelerated approval in adult patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO/NEXPOVIO is marketed in these respective ex-U.S. territories by Karyopharm’s partners: Antengene, Menarini, Neopharm, and FORUS. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in endometrial cancer and myelofibrosis.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at: Tel: +1 (888) 209-9326; Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (Xd).
For the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony‐stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3‐4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

On August 11, 2025 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) ("Ligand") reported its intention to offer $400.0 million aggregate principal amount of convertible senior notes due 2030 (the "notes") in a private placement (the "offering") to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), subject to market conditions and other factors (Press release, Ligand, AUG 11, 2025, View Source [SID1234655072]). Ligand also expects to grant to the initial purchasers of the notes (the "initial purchasers") a 13-day option to purchase up to an additional $60.0 million aggregate principal amount of notes.

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The notes will be general unsecured, senior obligations of Ligand and will accrue interest payable semiannually in arrears on April 1 and October 1 of each year, beginning on April 1, 2026. The notes will mature on October 1, 2030, unless earlier converted, redeemed or repurchased. Upon conversion of the notes, Ligand will pay cash up to the aggregate principal amount of the notes to be converted and pay or deliver, as the case may be, cash, shares of Ligand’s common stock or a combination of cash and shares of Ligand’s common stock, at Ligand’s election, in respect of the remainder, if any, of Ligand’s conversion obligation in excess of the aggregate principal amount of the notes being converted. The interest rate, initial conversion rate, redemption or repurchase rights and other terms of the notes will be determined at the time of pricing of the offering.

Ligand expects to use a portion of the net proceeds from the offering to pay the cost of the convertible note hedge transactions described below (after such cost is partially offset by the proceeds to Ligand from the sale of the warrants in the warrant transactions described below). In addition, Ligand expects to use up to $30 million of the net proceeds from the offering to repurchase shares of its common stock from certain purchasers of the notes in privately negotiated transactions, as described below. Ligand intends to use the remaining net proceeds from the offering for general corporate purposes including investing in complementary businesses, companies, products and technologies, although Ligand has no present commitments or agreements to do so. If the initial purchasers exercise their option to purchase additional notes, Ligand expects to sell additional warrants to the option counterparties and use a portion of the net proceeds from the sale of the additional notes, together with the proceeds from the sale of the additional warrants, to enter into additional convertible note hedge transactions and the remaining net proceeds for general corporate purposes.

In connection with the pricing of the notes, Ligand expects to enter into convertible note hedge transactions (the "convertible note hedge transactions") with one or more of the initial purchasers or their respective affiliates and/or other financial institutions (the "option counterparties"). Ligand also expects to enter into warrant transactions (the "warrant transactions") with the option counterparties, pursuant to which Ligand will issue warrants to purchase common stock (the "warrants") to such option counterparties. The convertible note hedge transactions are expected generally to reduce the potential dilution to Ligand’s common stock upon any conversion of notes and/or offset any cash payments Ligand is required to make in excess of the principal amount of converted notes, as the case may be. However, the warrant transactions could separately have a dilutive effect on Ligand’s common stock to the extent that the market price per share of common stock exceeds the strike price of the warrants. If the initial purchasers exercise their option to purchase additional notes, Ligand expects to enter into additional convertible note hedge transactions and additional warrant transactions with the option counterparties.

In connection with establishing their initial hedges of the convertible note hedge transactions and the warrant transactions, Ligand expects the option counterparties or their respective affiliates to enter into various derivative transactions with respect to Ligand’s common stock and/or purchase shares of Ligand’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Ligand’s common stock or the notes at that time.

The option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Ligand’s common stock and/or purchasing or selling shares of Ligand’s common stock or other securities of Ligand in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so in connection with any conversion, redemption or repurchase of the notes). This activity could also cause or avoid an increase or a decrease in the market price of Ligand’s common stock or the notes, which could affect a holder’s ability to convert its notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the number of shares of Ligand’s common stock, if any, and value of the consideration, if any, that a holder will receive upon conversion of its notes.

In addition, Ligand expects to use up to $30 million of the net proceeds from the offering to repurchase shares of its common stock from certain purchasers of the notes in privately negotiated transactions effected through one of the initial purchasers or an affiliate thereof concurrently with the pricing of the notes. The price per share of Ligand’s common stock repurchased in such transactions is expected to equal the last reported price per share of Ligand’s common stock as of the date of the pricing of the notes. These repurchases could increase (or reduce the size of any decrease in) the market price of Ligand’s common stock prior to, concurrently with or shortly after the pricing of the notes, and could result in a higher effective conversion price for the notes. Ligand cannot predict the magnitude of such market activity or the overall effect it will have on the market price of the notes and/or the market price of Ligand’s common stock.

The notes and the warrants will only be offered to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The notes, the warrants, the shares of common stock into which the notes are convertible and the shares of common stock issuable upon exercise of the warrants have not been, and will not be, registered under the Securities Act or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons, absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer to sell, solicitation of an offer to buy or sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On August 10, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the first patient has been dosed in its multicenter, randomized, double-blind Phase III study (AK112-311/HARMONi-9), evaluating ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by Akeso, in small cell lung cancer (SCLC) (Press release, Akeso Biopharma, AUG 10, 2025, View Source [SID1234655048]). This study is designed to assess the efficacy and safety of ivonescimab as consolidation therapy in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced progression following standard concurrent chemoradiotherapy (cCRT).

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AK112-311/HARMONi-9 study is the eighth registrational Phase III clinical trial for ivonescimab in lung cancer (including three international multicenter studies). The initiation of this trial further expands ivonescimab’s therapeutic coverage across key lung cancer indications and different lines of treatment. As the world’s first PD-1/VEGF bispecific antibody, ivonescimab is driving significant transformation in the overall lung cancer treatment landscape and holds the potential to fundamentally improve global lung cancer therapies.

Small cell lung cancer (SCLC) represents approximately 15% of all lung cancers and is known for its aggressive nature, early metastasis, and poor prognosis. Around 30% of patients are diagnosed at the limited stage (LS-SCLC), with over 80% being ineligible for surgical intervention. The current standard of care involves concurrent or sequential chemoradiotherapy (cCRT/sCRT), where most patients face recurrence or develop drug resistance. To date, only one PD-L1 therapy has been approved for consolidation treatment for LS-SCLC, highlighting the significant unmet clinical need of this difficult to treat cancer.

In previous studies focused on extensive-stage SCLC (ES-SCLC), ivonescimab has demonstrated its ability to prolong progression-free survival (PFS), combining the synergistic benefits of PD-1/L1 inhibitors and anti-angiogenic agents. Ivonescimab is a cornerstone in Akeso’s "IO 2.0" strategy, and Akeso has already initiated a series of Phase III and Phase II clinical trials investigating ivonescimab as a first-line treatment across multiple cancer indications. The initiation of a Phase III study of ivonescimab for LS-SCLC is another key step in extending Akeso’s "IO 2.0" approach to earlier stages of lung cancer.

On August 8, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt Cancer Center and principal investigator for the Company’s ongoing ovarian cancer CAR-T therapy Phase 1 clinical trial, will be presenting at the 13th Annual Ovarcoming Cancer Conference, being held September 18 – 19, 2025, virtually and in-person at the Briar Club in Houston, Texas (Press release, Anixa Biosciences, AUG 8, 2025, View Source [SID1234655030]).

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Dr. Wenham will join leading experts in the field to discuss advancements in ovarian cancer research and therapies, including Anixa’s CAR-T therapy. The presentation is scheduled for Thursday, September 18, 2025, from 12:05 PM – 12:30 PM CT.

Ovarcome is an ovarian cancer foundation envisioned to end the scourge of ovarian cancer. The Ovarcoming Cancer Conference brings together survivors, caregivers, and medical professionals to learn from world renowned experts on topics of greatest importance in the ovarian cancer landscape.

For more information about the conference, visit Ovarcoming Cancer Annual Conference 2025 – Ovarcome.

On August 8, 2025 Oncolys BioPharma reported Non-consolidated Financial Results for the Six Months Ended June 30, 2025.

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(Press release, Oncolys BioPharma, AUG 8, 2025, View Source [SID1234661741])