On September 15, 2025 Champions Oncology, Inc. (Nasdaq: CSBR), a leading translational oncology research organization, reported its financial results for its first quarter of fiscal 2026, ended July 31, 2025 (Press release, Champions Oncology, SEP 15, 2025, View Source [SID1234655973]).

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First Quarter and Recent Highlights:

•Total revenue of $14 million
•Adjusted EBITDA of $60,000
•Appointment of Rob Brainin as Chief Executive Officer to lead the next phase of growth

Rob Brainin, newly appointed CEO of Champions, commented, "It is great to be joining Champions at such an exciting inflection point. Our core services business—the backbone of our company—is strengthening and well positioned for sustained growth. At the same time, we are scaling our emerging data platform, which has already shown encouraging traction with leading biopharma partners. These complementary growth engines give us the opportunity to deepen our scientific impact, deliver innovative solutions to patients and customers, and create durable long-term value for shareholders. In parallel, our Corellia team continues to generate data demonstrating the potential of the compounds in our pipeline. Over the coming quarters, I look forward to working closely with our talented team to sharpen our strategy, invest in key capabilities, and build on Champions’ culture of collaboration and scientific excellence."

David Miller, CFO of Champions, added, "We opened the fiscal year with $14 million in revenue and adjusted EBITDA of $60,000. While revenue was slightly lower than the first quarter of last year, we achieved solid sequential growth that met our expectations and provides a strong foundation for the year. As we move forward, we anticipate continued topline expansion and margin improvement driven by a healthy services pipeline and growing demand for our proprietary data offerings. Our financial discipline and focus on profitable growth give us the flexibility to invest in strategic initiatives that will position Champions for long-term success."

First Fiscal Quarter Financial Results

Total oncology revenue for the first quarter of fiscal 2026 was $14.0 million compared to $14.1 million for the same period last year, consisting of a $400,000, or 3% decline in service revenue and a $300,000 increase in data license revenue. Total costs and operating expenses for the first quarter of fiscal 2026 were $14.5 million compared to $12.7 million for the first quarter of fiscal 2025, an increase of $1.8 million or 14.1%.

For the first quarter of fiscal 2026, Champions reported a loss from operations of $527,000, including $208,000 in stock-based compensation, $358,000 in depreciation and amortization expenses, and a $20,000 charge for the disposal of lab equipment, compared to income from operations of $1.3 million, inclusive of $258,000 in stock-based compensation and $448,500 in depreciation and amortization expenses, in the first quarter of fiscal 2025. Adjusted EBITDA, which is defined as income from operations excluding stock-based compensation, depreciation and amortization expenses, and equipment disposal charges, was $59,000 for the first quarter of fiscal 2026 compared to adjusted EBITDA of $2.0 million in the first quarter of fiscal 2025.

Cost of oncology revenue was $8.0 million, up $923,000, or 13.1%, from $7.1 million in the same period last year. The increase primarily reflects higher outsourced lab services for radiolabeling work, which will vary from quarter to quarter. Importantly, as we migrate this work into our own labs in the coming quarters, we anticipate a reduction in cost of sales and improvement in gross margins. Gross margin for the quarter was 43% compared to 50% in the prior year.

Research and development expense for the three-months ended July 31, 2025 was $2.1 million, an increase of $628,000 or 43.2%, compared to $1.5 million for the three-months ended July 31, 2024. The increase reflected greater investment in sequencing and related costs to develop our data licensing platform. Sales and marketing expense for the three-months ended July 31, 2025 was $1.9 million, an increase of $176,000, or 10.5%, compared to $1.7 million for the three-months ended July 31, 2024. The increase was related to compensation expense to support the growth of our data license business. General and administrative expense for the three-months ended July 31, 2025 was $2.6 million, an increase of $43,000, or 1.7%, compared to $2.5 million for the three-months ended July 31, 2024 driven primarily from an increase in IT related costs.

Net cash provided by operating activities was approximately $600,000 for the quarter, supported by receivables conversion and normal working capital activity, partially offset by a quarterly net loss. Net cash used in investing activities for the three-months ended July 31, 2025 was approximately $46,000 for lab and computer equipment. Net cash used in financing activities for the three-months ended July 31, 2025 was $14,000 resulting from financing lease payments slightly offset by proceeds from options exercises.

The Company ended the quarter with cash on hand of approximately 10.3 million and no debt, providing us with a strong balance sheet and financial flexibility.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its third quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 261008, or provide the verbal reference "Champions Oncology".

On September 15, 2025, BullFrog AI Holdings, Inc. (the "Company") reported to have entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement"), with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park committed to purchase up to $10.0 million of the Company’s common stock, par value $0.00001 per share (the "Common Stock"), subject to certain limitations and satisfaction of the conditions set forth in the Purchase Agreement (Filing, 8-K, Bullfrog AI, SEP 15, 2025, View Source [SID1234655993]).

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Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $10.0 million of the Company’s Common Stock (the "Purchase Shares"). Such sales of Common Stock by the Company, if any, will be subject to certain limitations set forth in the Purchase Agreement, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the date that the conditions to Lincoln Park’s purchase obligation set forth in the Purchase Agreement are satisfied, including that a registration statement covering the resale by Lincoln Park of shares of Common Stock that have been and may be issued to Lincoln Park under the Purchase Agreement, which the Company agreed to file with the U.S. Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC (the date on which all of such conditions are satisfied, the "Commencement Date").

From and after the Commencement Date, provided the last closing sale price of Common Stock is not below $0.50 at or immediately prior to the time of sale, the Company may, by written notice, direct Lincoln Park to purchase up to 30,000 shares of our Common Stock, which amount may be increased depending on the last closing sale price of Common Stock at or immediately prior to the time of sale, subject to a maximum commitment of $500,000 on such business day (or the purchase date) at a purchase price per share that will be determined in accordance with the Purchase Agreement at the time the Company delivers such written notice to Lincoln Park (a "Regular Purchase"). The purchase price per share for each Regular Purchase will be based on prevailing market prices of the Common Stock at or prior to the time of sale as computed in accordance with the terms set forth in the Purchase Agreement. There are no upper limits on the price per share that Lincoln Park must pay for shares of Common Stock under the Purchase Agreement.

If the Company directs Lincoln Park to purchase the maximum number of shares of Common Stock that the Company may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, the Company may direct Lincoln Park to purchase additional shares of Common Stock in an "accelerated purchase" (each, an "Accelerated Purchase") and an "additional accelerated purchase" (each, an "Additional Accelerated Purchase") (including multiple Additional Accelerated Purchases on the same trading day) as provided in the Purchase Agreement. The purchase price per share for each Accelerated Purchase and Additional Accelerated Purchase will be based on market prices of the Common Stock on the applicable purchase date for such Accelerated Purchases and such Additional Accelerated Purchases.

The Company will control the timing and amount of any sales of Common Stock to Lincoln Park pursuant to the Purchase Agreement. Lincoln Park has no right to require the Company to sell any shares of Common Stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions set forth in the Purchase Agreement.

Actual sales of shares of Common Stock to Lincoln Park will depend on a variety of factors to be determined by the Company from time to time, including, among others, general market conditions, the trading price of the Company’s Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park will be used for working capital, capital expenditures and general corporate purposes.

In the case of Regular Purchases, Accelerated Purchases and Additional Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute the purchase price.

The aggregate number of shares that the Company can sell to Lincoln Park under the Purchase Agreement may in no case exceed 2,048,936 shares (subject to adjustment as described above) of the Common Stock (which is equal to 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement) (the "Exchange Cap"), unless (i) stockholder approval is obtained to issue Purchase Shares above the Exchange Cap, or (ii) at the time the Company has issued shares of Common Stock equal to the Exchange Cap and at all times thereafter, the average price per share of Common Stock for all shares of Common Stock sold by the Company to Lincoln Park under the Purchase Agreement equals or exceeds $1.4053 per share (which represents the lower of (A) the official closing price of our Common Stock on Nasdaq on the trading day immediately preceding the date of the Purchase Agreement and (B) the average official closing price of our Common Stock on Nasdaq for the five consecutive trading days ending on the trading day immediately preceding the date of the Purchase Agreement, in each case as adjusted under applicable Nasdaq rules to take into account the issuance of shares of Common Stock to Lincoln Park for non-cash consideration as payment of the commitment fee described below so that the Exchange Cap limitation would not apply to issuances and sales of Common Stock under the Purchase Agreement pursuant to the rules and regulations of Nasdaq).

In all cases, the Purchase Agreement also prohibits the Company from directing Lincoln Park to purchase any shares of Common Stock if those shares, when aggregated with all other shares of Common Stock then beneficially owned by Lincoln Park (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder), would result in Lincoln Park beneficially owning more than 4.99% of the then total outstanding shares of Common Stock.

There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement, except the Company is prohibited (with certain specified exceptions set forth in the Purchase Agreement) from effecting or entering into an agreement to effect an "equity line of credit" or other substantially similar offering whereby an investor is irrevocably bound to purchase securities over a period of time from the Company at a price based on the market price of the Common Stock at the time of each such purchase. Lincoln Park has agreed not to engage in or effect, directly or indirectly, for its own principal account or for the principal account of any of its affiliates, any short sales of the Common Stock or hedging transaction that establishes a net short position in the Common Stock during the term of the Purchase Agreement.

Pursuant to the terms of the Purchase Agreement, the Company will issue 147,682 shares of Common Stock (the "Commitment Shares") to Lincoln Park as consideration for its commitment to purchase shares of Common Stock under the Purchase Agreement.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time with one business day notice, at no cost or penalty. Following the Commencement Date, if any "Suspension Event", as defined in the Purchase Agreement, occurs, Lincoln Park does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other purchase of shares by Lincoln Park, until such Suspension Event is cured.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are summaries and are qualified in their entirety by reference to the full texts of the Purchase Agreement and Registration Rights Agreement, which are filed as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K and incorporated herein by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of common stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On September 15, 2025 Limula, a Swiss life sciences tools company advancing automated solutions for cell and gene therapy (CGT) manufacturing reported the collaboration with the Institut Paoli-Calmettes (IPC) to characterise the cell processing capabilities of LimONE for haematopoietic stem cell (HSC) transplantation applications (Press release, Limula, SEP 15, 2025, View Source [SID1234655975]).

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IPC is internationally recognised as a leading treatment centre for cell therapies in haematological cancers and runs one of the most established autologous and allogeneic stem cell transplantation programmes in Europe. Performing more than 150 transplants each year, IPC is committed to advancing clinical innovation and broadening patient access to cutting-edge treatments.

The collaboration will leverage Limula’s automated and closed LimONE platform for autologous HSC transplantation, a procedure impacting nearly 50,000 patients annually in Europe. After promising preliminary results using an early prototype of Limula’s technology in 2022, and with strong confirmatory results earlier in 2025, IPC will further document the performance of LimONE. The goal of the collaboration is to advance automated cell product processing, with a focus on the removing of cryoprotectants and cell debris from thawed apheresis products. A fast and efficient wash is critical for maintaining the quality and consistency of the cell product and also significantly improves the patient experience.

"We are impressed with the improvements we saw during the development of LimONE and are eager to adopt the platform into our facility," said Boris Calmels, Head of the Cellular Manufacturing Unit at IPC. "I see strong potential for Limula’s technology to play a key role in improving both our cell processes and the patient’s experience during stem cell transplantation."

Luc Henry, CEO of Limula added: "This collaboration is a powerful demonstration of the versatility of our platform. We are proud to support IPC in their mission to deliver high-quality transplantation products to their patients."

On September 15, 2025 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported an agreement to collaborate with Novartis to develop novel degraders for immune- mediated diseases (Press release, Monte Rosa Therapeutics, SEP 15, 2025, View Source [SID1234655976]). The agreement is the Company’s second with Novartis, in addition to the global exclusive license agreement for Monte Rosa’s VAV1 degraders including MRT-6160, announced in October 2024.

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The agreement announced today was uniquely structured by the companies to collaborate on accelerating development of degraders for important immune-mediated diseases driven by highly credentialed and difficult-to-drug targets. Under the agreement, Monte Rosa’s scientists will apply their proprietary AI/ML-enabled QuEEN product engine for the discovery and development of degraders to be further developed and commercialized by Novartis.

"We are extremely excited to extend our relationship with Novartis beyond our previously announced VAV1 agreement given the strong progress made to advance MRT-6160 toward initiation of multiple Phase 2 studies in immune-mediated diseases," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "We believe this new agreement further strengthens our relationship with Novartis, a recognized global leader in immune-mediated diseases, and reflects the expansive opportunity in the space for our highly selective and potent MGDs. Our AI/ML-enabled QuEEN product engine continues to generate new insights and opportunities, delivering an expanding pipeline of programs directed against a breadth of historically undruggable immunology targets. This new collaboration allows us to expedite the development of certain of those programs with Novartis, leveraging their recognized development and commercialization capabilities. The agreement further strengthens our financial position, which allows us to progress our wholly owned programs, including multiple undisclosed targets in Th1, Th2, and Th17-driven autoimmune conditions, and provides runway beyond multiple anticipated Phase 2 readouts for MRT-8102, MRT-6160, and MRT-2359."

"We are pleased to expand our collaboration with Monte Rosa Therapeutics, building on the strong foundation and progress established through the VAV1 program," said Fiona Marshall, Ph.D., President of Biomedical Research at Novartis. "This new agreement underscores our commitment to advancing targeted protein degradation as a promising approach to address immune-mediated diseases with high unmet need. We believe Monte Rosa’s QuEEN platform has the potential to uncover new insights in this field. We look forward to working together to translate these insights into transformative therapies for patients."

Agreement Details and Financial Terms

Under the terms of the agreement, Monte Rosa will receive an upfront payment of $120 million. Monte Rosa will also receive payments to maintain the options. In total deal value, Monte Rosa is eligible to receive up to $5.7 billion, including upfront, option maintenance, preclinical milestone, option exercise, and development, regulatory, and sales milestone payments across programs, as well as tiered royalties on global net sales in the high single to low double-digit range.

Monte Rosa’s publicly disclosed pipeline programs are outside the scope of this agreement.

Monte Rosa plans to provide further information regarding its updated cash position and runway in its third quarter 2025 earnings update.

Lazard served as the exclusive financial advisor to Monte Rosa for this agreement.

On September 15, 2025 Merck reported that raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab (Press release, Merck & Co, SEP 15, 2025, View Source [SID1234655977]).

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Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

The FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine is required to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over currently available medicines.

The FDA granted this BTD based on data from a phase 1 trial and the ongoing REJOICE-Ovarian01 phase 2/3 trial. A subgroup analysis of the phase 1 trial was presented at the 2023 European Society for Medical Oncology meeting (#ESMO23). Subsequent subgroup analyses of the phase 1 trial were presented at the 2024 Society for Gynecologic Oncology Annual Meeting on Women’s Cancer and the 2025 European Society for Medical Oncology Gynaecological Cancers Congress. This is the first BTD for raludotatug deruxtecan and represents the second BTD since the start of the Daiichi Sankyo and Merck collaboration.

"Patients have limited treatment options once ovarian cancer becomes resistant to platinum-based chemotherapy, highlighting the urgent need for new medicines that can improve patient outcomes," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "The receipt of Breakthrough Therapy Designation represents an important step forward in our efforts to advance raludotatug deruxtecan as a novel medicine for patients with CDH6 expressing platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab."

"The FDA’s Breakthrough Designation is a reflection of our commitment to advancing research for patients impacted by women’s cancers," said Eliav Barr, MD, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. "Raludotatug deruxtecan has the potential to one day become an important option for the treatment of patients with CDH6-expressing platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab, and we are excited to share data from REJOICE-Ovarian01 with the scientific community at an upcoming medical meeting and to continue working closely with the FDA."

About the Phase 1 Trial

The two-part, multicenter, open-label, first-in-human phase 1 trial is evaluating the safety and efficacy of investigational raludotatug deruxtecan in adult patients with advanced ovarian cancer previously treated with platinum-based chemotherapy and a taxane. Patients with renal cell carcinoma resistant or refractory to standard of care therapy were originally included, but that component of the study was discontinued.

The primary objective of the first part of the study (dose escalation) was to assess the safety and tolerability of increasing doses of raludotatug deruxtecan to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE). The primary objective of the second part of the study (dose expansion) is to further evaluate the safety and efficacy of raludotatug deruxtecan in patients with advanced ovarian cancer and in patients with advanced renal cell carcinoma.

The study will evaluate safety endpoints, including dose-limiting toxicities and adverse events and efficacy endpoints, including objective response rate (ORR), duration of response (DoR), disease control rate (DCR), clinical benefit rate, time to response and progression free survival (PFS). Pharmacokinetic and exploratory biomarker endpoints also will be assessed.

The phase 1 trial enrolled 179 patients in Asia and North America. For more information, please visit ClinicalTrials.gov.

About REJOICE-Ovarian01

REJOICE-Ovarian01 is a global, multicenter, randomized, open-label phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan in patients with platinum-resistant, high-grade ovarian primary peritoneal or fallopian tube cancer, with disease progression following at least one but no more than three prior systemic lines of therapy, including prior treatment with mirvetuximab soravtansine for those with documented high-folate receptor alpha expression. Maintenance therapy (e.g., bevacizumab, poly ADP-ribose polymerase [PARP] inhibitors) is considered part of the preceding line of therapy.

The phase 2 part of REJOICE-Ovarian01 is assessing the safety and tolerability of three doses of raludotatug deruxtecan (4.8 mg/kg, 5.6 mg/kg, or 6.4 mg/kg) to identify the recommended dose for the phase 3 part of the trial. The primary endpoint of the phase 2 part of the trial is ORR as assessed by blinded independent central review (BICR). Secondary endpoints include ORR as assessed by investigator, DoR, PFS and DCR – all assessed by both BICR and investigator – and overall survival (OS).

The phase 3 part of REJOICE-Ovarian01 is assessing the efficacy and safety of raludotatug deruxtecan at the selected dose (5.6 mg/kg) compared to investigator’s choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicin, gemcitabine or topotecan). The dual primary endpoints of the phase 3 part of the trial are ORR and PFS as assessed by BICR. Secondary endpoints include PFS and ORR as assessed by investigator, DoR and DCR as assessed by both BICR and investigator, and OS. Pharmacokinetic and biomarker endpoints also will be assessed in both parts of the trial.

REJOICE-Ovarian01 is expected to enroll approximately 710 patients across Asia, Europe, North America, and Oceania. For more information, please visit ClinicalTrials.gov.

About Ovarian Cancer

More than 324,000 women were diagnosed with ovarian cancer worldwide in 20221. The median overall survival for advanced ovarian cancer following recurrence can be as little as two years, with a five-year survival rate of 31.8% for those with distant stage disease.2,3

The introduction of targeted therapies has expanded treatment options and improved survival outcomes for some patients with ovarian cancer, but additional options are needed for patients with tumors that progress on available medicines4. Between 70% and 80% of patients diagnosed with advanced ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens5. For patients who develop platinum-resistant ovarian cancer, defined as disease progression less than six months after completion of last platinum-based chemotherapy, prognosis is particularly poor and treatment options are limited.6,7

About CDH6

CDH6 (human cadherin-6) is a cadherin family protein overexpressed in several cancers, including ovarian tumors.8 An estimated 65% of patients with ovarian cancer have tumors that express CDH6. In addition, CDH6 expression is observed more frequently in high-grade serous carcinomas.8,9 There is currently no CDH6 directed medicine approved for treatment of any cancer.

About Raludotatug Deruxtecan

Raludotatug deruxtecan is an investigational, potential first-in-class CDH6 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, raludotatug deruxtecan is comprised of a humanized anti-CDH6 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.