On May 1, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported first quarter 2025 financial results and provided a corporate update (Press release, Kura Oncology, MAY 1, 2025, View Source [SID1234652445]).

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"In the first quarter of 2025, we achieved a significant milestone with the submission of our first NDA for ziftomenib, said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We are committed to working with FDA to support its review and are strategically advancing our pre-commercial activities to prepare for potential approval for the treatment of adult patients with relapsed or refractory NPM1-mutant AML. Beyond the monotherapy setting, we look forward to sharing data on the combination of ziftomenib with intensive and non-intensive standards of care, while gearing up for two Phase 3 studies in the frontline setting. With a strong pipeline, multiple clinical data readouts expected this year, and a solid financial foundation, we are well-positioned to drive progress across our programs."

Recent Highlights

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Submission of New Drug Application for ziftomenib to FDA – Kura and Kyowa Kirin Co., Ltd. (Kyowa Kirin) announced submission of the New Drug Application (NDA) for ziftomenib for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation to the U.S. Food and Drug Administration (FDA) on March 31, 2025. From the time of submission, the FDA has a 60-day filing review period, and the Company expects to receive notification from the FDA on this preliminary evaluation in the second quarter of 2025. If Priority Review is granted, it would provide a target FDA review period of six months after NDA acceptance.

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Abstracts accepted for presentation at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) – In February 2025, Kura and Kyowa Kirin announced positive topline results from the KOMET-001, the Phase 2 registration-directed trial of ziftomenib in patients with R/R NPM1-mutant (NPM1-m) AML. These data have been accepted for oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago and accepted for an encore presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Milan, Italy. In addition, preliminary clinical data from the Phase 1b expansion cohort evaluating ziftomenib in combination with intensive (7+3) in the frontline setting has been accepted for an oral presentation at EHA (Free EHA Whitepaper). Abstract titles and presentation details can be found on the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) meeting sites at the lift of the respective embargos.

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Submission of the NDA for ziftomenib has triggered a $45 million milestone payment obligation from Kyowa Kirin – As a result of the NDA submission for ziftomenib, Kura has earned a $45 million milestone payment under the global strategic collaboration agreement between Kura and Kyowa Kirin to develop and commercialize ziftomenib in acute leukemias (Kyowa Agreement). Under the terms of the Kyowa Agreement, Kura received an upfront payment of $330 million in December 2024 and accounting for this $45 million milestone payment, Kura expects to receive up to $375 million in additional, near-term milestone payments.

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First patients dosed in KOMET-015 trial in GIST – Earlier this week, Kura announced the first patients have been dosed in its KOMET-015 Phase 1 clinical trial of ziftomenib in patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure. In October 2024, Kura presented preclinical data at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, supporting the potential for ziftomenib in combination with KIT inhibitors for the treatment of GIST. The combination of ziftomenib and imatinib demonstrated robust and durable antitumor activity in imatinib-sensitive (1L) and imatinib-resistant (2L/3L) GIST patient-derived xenograft models.

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Preclinical data for KO-2806 presented in oral minisymposium session at AACR (Free AACR Whitepaper) Annual Meeting – Last month, Kura presented preclinical data for KO-2806, the Company’s next-generation farnesyl transferase inhibitor (FTI), in combination with cabozantinib for the treatment of clear cell renal cell carcinoma at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago. These data add to a growing body of preclinical evidence demonstrating the potential of FTIs as companion therapeutic agents to augment the antitumor activities of and to overcome resistance to various targeted therapies.

Financial Results

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Collaboration revenue from our Kyowa Kirin partnership for the first quarter of 2025 was $14.1 million, compared to no revenue for the first quarter of 2024.

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Research and development expenses for the first quarter of 2025 were $56.0 million, compared to $36.3 million for the first quarter of 2024.

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General and administrative expenses for the first quarter of 2025 were $22.8 million, compared to $18.2 million for the first quarter of 2024.

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Net loss for the first quarter of 2025 was $57.4 million, compared to a net loss of $49.5 million for the first quarter of 2024.

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Net loss for the first quarter of 2025 included non-cash, share-based compensation expense of $7.8 million. This compares to $8.5 million for the same period in 2024.

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As of March 31, 2025, Kura had cash, cash equivalents and short-term investments of $658.2 million, compared to $727.4 million as of December 31, 2024.

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As adjusted for the $45 million NDA submission milestone payment earned under our collaboration agreement with Kyowa Kirin, Kura had, on a pro forma basis, $703.2 million in cash, cash equivalents and short-term investments as of March 31, 2025.

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Based on our current plans, we believe our cash, cash equivalents and short-term investments as of March 31, 2025 will be sufficient to enable us to fund our current operating expenses into 2027 and, combined with anticipated collaboration funding under the Kyowa Agreement, should support our ziftomenib AML program through commercialization in the frontline combination setting.

Forecasted Milestones

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Present data from the KOMET-001 Phase 1b/2 registration-directed trial in R/R NPM1-m AML at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) in the second quarter of 2025.

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Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib with intensive chemotherapy (7+3) in the frontline setting at EHA (Free EHA Whitepaper) in the second quarter of 2025.

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Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib with venetoclax and azacitidine in the frontline setting at a medical meeting in the second half of 2025.

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Initiate two independent Phase 3 registration-enabling trials in 1L intensive (KOMET-017-IC) and non-intensive (KOMET-017-NIC) AML in the second half of 2025.

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Nominate a development candidate for next-generation menin inhibitor program in diabetes in mid-2025.

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Initiate one or more FIT-001 expansion cohorts of KO-2806 and cabozantinib in patients with advanced renal cell carcinoma in the second half of 2025.

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Present data from the FIT-001 Phase 1 trial evaluating KO-2806 and cabozantinib in patients with renal cell carcinoma in the second half of 2025.

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Present data from the FIT-001 Phase 1 monotherapy dose escalation of KO-2806 in patients with RAS mutations in the second half of 2025.

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Present data from the KURRENT-HN trial evaluating tipifarnib and alpelisib in PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC) in the second half of 2025.

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, May 1, 2025, to discuss the financial results for the first quarter of 2025 and to provide a corporate update. The live call may be accessed by dialing (800) 245-3047 for domestic callers and (203) 518-9765 for international callers and entering the conference ID: KURAQ1. A live webcast and archived replay of the event will be available here or online from the investor relations section of the Company’s website at www.kuraoncology.com.

On May 1, 2025 Illumina, Inc. (NASDAQ: ILMN), and Ovation.io, Inc., an organization dedicated to building best-in-class multiomics datasets, reported the development of the largest commercially available clinical multiomic dataset from 25,000 patients treated with glucagon-like peptide-1 (GLP-1) receptor agonist therapies (Press release, Illumina, MAY 1, 2025, View Source [SID1234652464]). The dataset will be made available to the pharma community to advance drug discovery and development. This collaboration is the latest in a series of efforts to partner across the ecosystem, and deploy multimodal data to advance a deeper understanding of biology.

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One in eight adults in the United States have used a GLP-1 receptor agonist, according to a 2024 health tracking poll conducted by the Kaiser Family Foundation. However, roughly 40% of users with Type 2 diabetes do not respond effectively to GLP-1 receptor agonists, according to a study published in Diabetes & Metabolic Syndrome in 2024. The collaboration aims to accelerate GLP-1 therapy development, indication expansion research, and discovery of novel biomarkers and drug targets in nonresponsive populations.

"The power of whole-genome and multiomic insights to impact all diseases is coming into focus, and metabolic disease is a prime example," said Todd Christian, senior vice president of Services, Arrays, and Genomic Access at Illumina. "This collaboration and its novel clinical dataset will be crucial to advancing the next wave of these potential life-changing therapies, and ensuring more patients can benefit from them."

Through a multiyear agreement, Illumina and Ovation are launching an integrated dataset of phenotypic, genomic, and proteomic data from patients treated with GLP-1 therapies, including therapy-responsive and nonresponsive populations. This critical dataset is designed to enable deeper understanding of molecular pathways involved in GLP-1 response, which can unlock new indications where GLP-1 therapies may be effective, as well as new biomarkers and drug targets for patients who do not respond to GLP-1 therapies today.

"We’re proud to collaborate with Illumina to develop one of the world’s largest WGS omics datasets, supporting the millions of patients with diabetes and obesity," said Marty Miller, chief revenue officer of Ovation. "Through this effort—and for the first time at scale with the inclusion of proteomics—we aim to equip the pharmaceutical industry with the insights needed to better understand the varying effectiveness and side effects of GLP-1 receptor agonists across individual patients."

The initiative leverages end-to-end Illumina NGS technologies to sequence 25,000 whole genomes and to profile the protein expression of 5000 samples, using the Illumina Protein Prep (IPP) assay, which detects 9500 human proteins per sample. The initiative aims to include a longitudinal subset of proteomes from paired samples collected before and after patient exposure to GLP-1 therapy.

IPP enables the discovery of new protein quantitative trait loci (pQTL), which are emerging as a vital tool for drug discovery, linking genetic variation with protein expression data and disease or other phenotypes. The pQTL dataset is processed using Illumina’s industry-leading DRAGEN secondary analysis and the newly released Illumina Connected Multiomics for tertiary analysis and visualizations. The data is stored for future large-scale studies in Illumina Connected Analytics.

Ovation is providing samples from its biobank of over 1.7 million de-identified, consented, and tokenized samples, linked to rich, longitudinal phenotypic data.

Ovation announced an original agreement with Illumina in 2024, aimed at addressing challenges in drug development through genomic data solutions. The initial phase of the collaboration focused on creating pilot datasets from patients with liver disease, chronic kidney disease, and patients treated with GLP-1 receptor agonists. The companies plan to explore opportunities to scale the GLP-1 dataset and generate others in the future.

On May 1, 2025 Biogen Inc. (NASDAQ: BIIB) reported first quarter 2025 financial results (Press release, Biogen, MAY 1, 2025, View Source [SID1234652426]).

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"Biogen delivered strong first-quarter results, supporting our strategy for long-term growth. We are encouraged by the transformation in our commercial product portfolio, with approximately 45% of total product revenue in the first quarter derived from important medicines outside of our MS business," said Christopher A. Viehbacher, President and Chief Executive Officer. "In an environment of potential tariffs and medical supply security concerns, Biogen operates a significant manufacturing presence in the U.S. Roughly 75% of our 2024 U.S. product revenues were generated by products which have manufacturing operations in the U.S. In addition, Biogen pays substantial taxes in the U.S. since our U.S. market revenues are almost entirely taxable in the U.S. at Federal and state tax rates."

Financial Highlights
Q1 ’25 Q1 ’24 △
r (CC*)
Total Revenue (in millions) $2,431 $2,290 6% 8%
GAAP diluted EPS $1.64 $2.70 (39)% N/A
Non-GAAP diluted EPS $3.02 $3.67 (18)% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

First quarter 2025 GAAP and Non-GAAP diluted EPS reflects the ~($0.95) impact from a $165 million upfront transaction payment to Stoke related to the collaboration agreement for zorevunersen in Dravet syndrome.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q1 ’25 Q1 ’24 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$953 $1,076 (11)% (10)%
Rare disease revenue(2)
$563 $424 33% 36%
Biosimilars revenue $181 $197 (8)% (5)%
Other product revenue(3)
$29 $15 93% 92%
Total product revenue $1,727 $1,712 1% 3%
Revenue from anti-CD20 therapeutic programs $378 $394 (4)% (4)%
Alzheimer’s collaboration revenue(4)
$33 $3 NMF NMF
Contract manufacturing, royalty and other revenue $293 $182 61% 63%
Total revenue $2,431 $2,290 6% 8%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
NMF = no meaningful figure.
(1) Multiple sclerosis includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective
January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE – First quarter 2025 ZURZUVAE revenue was approximately $28 million.
(4) Includes Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.
Expense Summary
(in millions) Q1 ’25 Q1 ’24 △
GAAP cost of sales*
$629 $542 (16)%
% of Total Revenue 26% 24%
Non-GAAP cost of sales*
$580 $500 (16)%
% of Total Revenue 24% 22%
GAAP R&D expense $434 $445 3%
Non-GAAP R&D expense $427 $439 3%
GAAP SG&A expense $573 $582 2%
Non-GAAP SG&A expense $572 $569 (1)%
GAAP acquired in-process R&D (IPR&D), upfront and milestone expense $201 $8 NMF
Non-GAAP acquired IPR&D, upfront and milestone expense $201 $8 NMF

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
NMF = no meaningful figure.
* Excluding amortization and impairment of acquired intangible assets

•The increase in first quarter 2025 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by product mix, particularly the year-over-year increase in contract manufacturing revenue, partially offset by an increase in launch product revenue.

•The decrease in first quarter 2025 GAAP and Non-GAAP R&D expense was driven primarily by savings from the Company’s R&D prioritization and Fit for Growth initiatives.

•The decrease in first quarter 2025 GAAP SG&A was driven primarily by the Company’s Fit for Growth initiative, partially offset by sales and marketing spend to support product launches.

•The increase in first quarter 2025 Non-GAAP SG&A was driven primarily by sales and marketing spend to support product launches, partially offset by savings from the Company’s Fit for Growth initiative.

•First quarter 2025 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was approximately $201 million and includes a $165 million upfront transaction payment to Stoke related to the collaboration agreement for zorevunersen, and a $35 million milestone to MorphoSys AG as part of the initiation of the Phase 3 trial of felzartamab in antibody-mediated rejection.
Other Financial Highlights

•First quarter 2025 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $58 million, which includes approximately $48 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $10 million related to Biogen’s collaboration with Sage Therapeutics, Inc. and the commercialization of ZURZUVAE in the U.S.

•First quarter 2025 GAAP other expense was approximately $68 million, primarily driven by net interest expense and net losses on strategic equity investments. First quarter 2025 Non-GAAP other expense was approximately $33 million, primarily driven by net interest expense.

•First quarter 2025 GAAP and Non-GAAP effective tax rates were 22.7% and 19.4%, respectively. First quarter 2024 GAAP and Non-GAAP effective tax rates were 15.4% and 15.9%, respectively.
Financial Position

•First quarter 2025 net cash flow from operations was approximately $259 million. Capital expenditures were approximately $37 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was approximately $222 million.

•As of March 31, 2025, Biogen had cash and cash equivalents totaling approximately $2.6 billion and approximately $6.3 billion in total debt, resulting in net debt of approximately $3.7 billion.

•For the first quarter of 2025 the Company’s weighted average diluted shares were approximately 147 million.
3

Full Year 2025 Financial Guidance

For the full year 2025, Biogen’s expected underlying business outlook remains unchanged and Biogen is updating its expected Non-GAAP diluted EPS guidance range to reflect the $165 million upfront transaction payment to Stoke and more favorable foreign exchange as follows:
Full Year 2025 Non-GAAP Diluted EPS
Prior Guidance (February 2025) $15.25 to $16.25
Approx. impact from $165 million Stoke upfront
($0.95)
Benefit mainly from foreign exchange +$0.20
Updated Guidance $14.50 to $15.50

This updated Non-GAAP diluted EPS guidance range reflects the ~($0.95) impact from a $165 million upfront transaction payment to Stoke related to the collaboration agreement for zorevunersen in Dravet syndrome, partially offset by a $0.20 benefit mainly from foreign exchange.
For 2025 as compared to 2024, Biogen expects total revenue to decline by a mid-single digit percentage as further declines in multiple sclerosis product revenue are expected to be partially offset by increases in revenue from product launches.
The Fit for Growth program is expected to generate approximately $1 billion of gross savings and $800 million net of reinvestment by the end of 2025. Biogen expects combined Non-GAAP R&D expense and Non-GAAP SG&A expense to total approximately $3.9 billion in 2025.
This financial guidance incorporates the Company’s view that Biogen’s 2025 financial outlook is not currently expected to be materially impacted by potential tariffs as previously announced by the U.S. Administration on April 2, 2025, even if the exemption for pharmaceuticals were to be removed. This is based on both a significant proportion of U.S. revenue being derived from products which have manufacturing operations in the United States, and the Company’s current global inventory positions. The U.S. and international tariff landscape remains uncertain, and this guidance does not include contemplation of any new tariffs.
This financial guidance also assumes that foreign exchange rates as of April 25, 2025, will remain in effect for the remainder of the year, net of hedging activities.
This financial guidance does not include any impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential tax or healthcare reform, as all are hard to predict. Other modeling considerations will be provided on the conference call and webcast.
Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2025 that could cause any of these assumptions to change and/or actual results to vary from this financial guidance.
Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from equity security investments; and the ultimate outcome of pending or future significant litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Other Key Recent Events

•Today Biogen announced that BIIB122, a LRRK2 inhibitor for Parkinson’s disease developed in collaboration with Denali Therapeutics, Phase 2b LUMA study has fully enrolled with a readout expected in 2026.

•Today Biogen announced that it plans to host a series of investor events to highlight the development pipeline. Biogen plans to hold the first virtual event on June 11th at 10 a.m. ET with a focus on felzartamab and rare disease. Biogen does not intend to disclose new clinical data on the call.

Conference Call and Webcast

The Company’s earnings conference call for the first quarter will be broadcast via the internet at 8:30 a.m. ET on May 1, 2025 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

On May 1, 2025 Kyowa Hakko Kirin reported consolidated Financial Results Fiscal 2025 First Quarter (Press release, Kyowa Hakko Kirin, MAY 1, 2025, View Source [SID1234652446]).

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On May 1, 2025 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, reported that its new generation pan-TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which accepted the New Drug Application (NDA) of zurletrectinib for the treatment of patients with advanced solid tumors harboring NTRK gene fusions recently (Press release, InnoCare Pharma, MAY 1, 2025, View Source [SID1234652465]). Priority review is one of the key policies introduced by the CDE to accelerate drug approval.

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In the registrational trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy with a good safety profile.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, "We are delighted that zurletrectinib has been granted priority review. Zurletrectinib has demonstrated outstanding efficacy and a favorable safety profile. We anticipate it will provide better treatment options for eligible patients with solid tumors earlier."

Zurletrectinib is a pan-TRK inhibitor developed by InnoCare. British Journal of Cancer, part of leading science journal Nature, published a paper entitled "Zurletrectinib is a next-generation TRK inhibitor with strong intracranial activity against NTRK fusion-positive tumors with on-target resistance to first-generation agents"1.

NTRK fusion genes occur in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK gene fusion exceeds 90%2. It is estimated that there are about 6,500 new cases of NTRK fusion-positive solid tumors are diagnosed in China each year. There are significant unmet clinical needs in this area due to lack of effective treatment options.