Kura Oncology (NASDAQ:KURA), Inc., a pharmaceutical company, has entered into a significant agreement with Kyowa Kirin Co., Ltd., as announced today. The collaboration centers on the global development and commercialization of Kura's ziftomenib, an experimental treatment for acute myeloid leukemia (AML) and other hematologic malignancies.
Under the terms of the agreement, Kura Oncology will receive an upfront payment of $330 million, with the potential for up to $420 million in near-term milestone payments, including upon the launch of ziftomenib for relapsed/refractory AML. The agreement could yield Kura up to $1.491 billion in total payments, including additional development, regulatory, and commercial milestones.
Kura Oncology will lead development and commercialization efforts for ziftomenib in the United States, while Kyowa Kirin will take charge of these activities outside the U.S. The companies will share equally in the U.S. development costs beyond the initial development plan slated before the end of 2028, as well as profits or losses from the commercialization in the U.S. market.
Kyowa Kirin has also been granted an option to broaden collaboration to include gastrointestinal stromal tumors (GIST) and other solid tumor indications, contingent upon clinical data from ongoing studies. If exercised, this expansion would bring additional upfront and milestone payments totaling $228 million for Kura.
The agreement stipulates that Kura will be responsible for the global manufacture and supply of ziftomenib, with a provision for Kyowa Kirin to potentially take over commercial supply responsibilities outside the United States.
Kura retains rights to its ongoing development of next-generation menin inhibitor drug candidates for oncology, diabetes, and metabolic diseases, with certain restrictions. Both parties have agreed to exclusivity terms, prohibiting the commercialization of any molecule with similar menin inhibition functions outside the terms of the agreement.
The collaboration is subject to termination clauses for material breach, insolvency, or at Kyowa Kirin's convenience with prior notice. Kura may terminate if Kyowa Kirin challenges the validity of any licensed patent rights.
This partnership represents a significant step for Kura Oncology, potentially accelerating the development and availability of ziftomenib for patients with AML and other malignancies. The details of the agreement will be disclosed in Kura's upcoming annual report to the SEC.
This article is based on a press release statement.
In other recent news, Kura Oncology has reported significant progress in its clinical programs, with a notable emphasis on the menin inhibitor ziftomenib, showing potential in treating acute myeloid leukemia (AML).
Despite a rise in R&D expenses to $41.7 million and a net loss of $54.4 million in Q3 2024, the company's cash and short-term investments total $455.3 million, projected to fund operations into 2027. H.C. Wainwright maintained a Buy rating for Kura Oncology, following the recent FDA approval of Syndax Pharmaceuticals (NASDAQ:SNDX)' Revuforj.
The AUGMENT-101 and KOMET-001 trials are expected to release results in the first quarter of 2025, potentially leading to the development of new menin inhibitors for treating r/r AML populations.
Kura Oncology is set to present preliminary data for various clinical trials at the American Society of Hematology meeting, planning to initiate pivotal studies for ziftomenib by mid-2024 with an NDA filing expected by late 2024.
In addition, the company plans to nominate a next-generation menin inhibitor candidate for diabetes in the first half of 2025. These recent developments point to Kura Oncology's continued focus on innovation in the field of oncology.
InvestingPro Insights
The recent collaboration between Kura Oncology and Kyowa Kirin could significantly impact Kura's financial position. According to InvestingPro data, Kura Oncology currently has a market capitalization of $1.23 billion, which puts the potential $1.491 billion in total payments from this deal into perspective.
InvestingPro Tips reveal that Kura "holds more cash than debt on its balance sheet" and "liquid assets exceed short term obligations," suggesting a solid financial foundation to support this new venture. However, it's worth noting that the company "is not profitable over the last twelve months" and "net income is expected to drop this year."
Despite these challenges, Kura has seen a "high return over the last year," with a 1-year price total return of 66.6%. This positive momentum could be further bolstered by the new partnership, potentially addressing the fact that "7 analysts have revised their earnings downwards for the upcoming period."
For investors seeking a more comprehensive analysis, InvestingPro offers 5 additional tips for Kura Oncology, providing a deeper understanding of the company's financial health and market position.
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