On July 28, 2025 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC) (Press release, MAIA Biotechnology, JUL 28, 2025, View Source [SID1234654586]). Ateganosine is currently being evaluated in a pivotal Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor.

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Ateganosine is a first-in-class small molecule that compromises telomere structure and function in cancer cells, leading to rapid tumor cell elimination and specific immune memory. Through telomerase-mediated action, ateganosine reverses intrinsic or acquired resistance to immune checkpoint inhibitors (ICIs).

"FDA’s Fast Track Designation recognizes ateganosine’s potential as a new therapeutic paradigm in cancer treatment science. Ateganosine is the first and only anticancer treatment of its kind that we are aware of in clinical development," stated MAIA Chairman and CEO Vlad Vitoc, M.D. "If we are successful in the Fast Track regulatory pathway, ateganosine could qualify for accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year. If approved, ateganosine would have a first-to-market competitive position within a $34 billion NSCLC treatment market with significant unmet medical need."

NSCLC represents one of the largest global oncology indications. The market was valued at $34.1B in 2024 and is projected to reach $68.8B by 2033 with a projected CAGR of 8.1%.1

"This is an important milestone for MAIA’s clinical development program. Ateganosine has demonstrated robust preclinical efficacy and superior clinical median overall survival compared to other FDA-approved treatments for NSCLC patients with prior disease progression on platinum-based chemotherapy and anti-PD-(L)1 antibody. Additionally, advanced NSCLC is a devastating disease that clearly meets the criteria for a serious condition with unmet medical need. Both are key criteria for the Fast Track designation," said K. Robinson Lewis, Vice President, Head of Regulatory and Quality at MAIA. "We intend to utilize the incentives of the Fast Track Program to expedite the development and review of ateganosine and bring patient access sooner."

The FDA Fast Track is a process designed to facilitate development and expedite the review of drugs for treating serious conditions and filling an unmet medical need, as in providing a therapy where none exists or which may be potentially better than available therapy. If relevant criteria are met during the Fast Track process, a drug will be eligible for FDA Accelerated Approval and Priority Review (FDA decision within six months).

MAIA’s most recent data from the pivotal Phase 2 THIO-101 clinical trial of ateganosine as of May 15, 2025 showed median overall survival (OS) of 17.8 months in a heavily pre-treated population. As of the data cut-off date, the patient with the longest survival in the trial had completed 32 cycles of therapy and had 24.3 months survival. Studies of standard-of-care chemotherapy treatments for NSCLC in a similar setting have shown overall survival of 5 to 6 months.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On July 28, 2025 Celyad Oncology (Euronext: CYAD) (the "Company" or "Celyad") reported that it has entered into a subscription agreement for a private placement financing (Press release, Celyad, JUL 28, 2025, View Source [SID1234654570]).

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Under the terms of the agreement, CFIP CLYD (UK) Limited ("Fortress") will subscribe to a capital increase for an aggregate amount of €1 million in exchange for 3,333,333 newly issued ordinary shares of Celyad. The shares will be issued at a subscription price of EUR 0.30 per share, which represents a 15% discount to the volume-weighted average price (VWAP) of Celyad’s shares on Euronext Brussels over the ten (10) trading days preceding the date of signing. Fortress’s subscription commitment is subject to customary conditions precedent. The closing is expected to take place on or around August 5, 2025. CFIP CLYD (UK) Limited is an affiliate of Fortress Investment Group.

The private placement is being conducted within the limits of the Company’s authorized capital as approved by the Extraordinary Shareholders’ Meeting of 14 November 2023, with cancellation of the preferential subscription rights of the existing shareholders in favor of Fortress. Following and subject to the issue of the shares to Fortress, Fortress is expected to hold approximately 58.51% of the Company’s shares.

The net proceeds of the placement will be used to support the working capital of the Company for general corporate purposes. The Company believes that following the close of the private placement, its cash runway will be extended from mid Q3 2025 to mid Q4 2025 which will give additional time for the Company to evaluate its strategic options to strengthen its balance sheet.

As Fortress qualifies as a related party of the Company, the board of directors applied Article 7:97 of the Belgian Code of Companies and Associations (the "BCCA"), which requires, among other things, the intervention of a committee of independent directors to give an opinion to the board of directors. The conclusions of the committee’s opinion is as follows: "The Committee has assessed the envisaged Transaction in light of the criteria included in article 7:97 of the BCCA and concluded, in view of the Company’s financial situation and cash flow requirements, after considering and examining alternative funding options and taking into account the interest of all stakeholders, that the expected advantages of the Transaction outweigh the expected disadvantages thereof, which leads to the conclusion that the Transaction is to the advantage and in the interest of the Company. The Transaction is in line with the Company’s strategic policy and is not manifestly unreasonable and the Committee affirms its positive advice in relation to the Transaction". The directors previously appointed by Fortress did not participate in the deliberations or votes.

In light of the Company’s limited cash runway, the board of directors believes that the envisaged capital increase is in the best interests of the Company and its stakeholders because, if completed, the capital increase will give additional time for the Company to evaluate its strategic options to strengthen its balance sheet. In accordance with article 7:97 of the BCCA, the Company’s auditor has issued a report on the accounting and financial information contained in the committee’s opinion and the board minutes approving the related party transaction. The auditor’s conclusion in this respect is as follows: "Based on our assessment, nothing has come to our attention that causes us to believe that the accounting and financial information included in the advice of the committee of independent directors dated July 23, 2025 and in the minutes of the Board of Directors dated July 23, 2025, justifying the proposed transaction, is not fair and sufficient, in all material respects, with regard to the information available to us within the scope of our mission."

On July 28, 2025 Deciphera Pharmaceuticals, LLC, a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines, and Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of vimseltinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability (Press release, Deciphera Pharmaceuticals, JUL 28, 2025, View Source [SID1234654587]).

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The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC), which has the authority to approve medicines in the European Union (EU), issues a decision on Deciphera’s marketing authorization application (MAA) for vimseltinib. This decision is expected in the second quarter of the fiscal year ending March 31, 2026.

"CHMP’s positive opinion is an important milestone for the TGCT community in the European Union (EU), where there are currently no approved treatments for TGCT, and for vimseltinib, which is now one step closer to potential EU regulatory approval," said Ryota Udagawa, President and Chief Executive Officer of Deciphera. "We look forward to building upon vimseltinib’s positive CHMP opinion as we work to bring this medicine to TGCT patients around the world in need of new treatment options."

The positive CHMP opinion is supported by compelling efficacy and safety results from the pivotal Phase 3 MOTION study of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed), compared to placebo, as well as the Phase 1/2 study of vimseltinib. In MOTION, vimseltinib demonstrated a statistically significant and clinically meaningful objective response rate (ORR) at Week 25 in the intent-to-treat (ITT) population, as assessed by blinded independent radiologic review (BIRR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), versus placebo (40% in vimseltinib arm vs 0% in placebo arm, p <0.0001). The primary endpoint was supported by statistically significant and clinically meaningful improvements in active range of motion, patient-reported physical functioning, and patient-reported pain observed in the vimseltinib arm compared to the placebo arm at week 25. The safety profile of vimseltinib is manageable and consistent with results previously disclosed in the Phase 1/2 clinical trial.

About vimseltinib

Vimseltinib is an oral switch-control tyrosine kinase inhibitor specifically designed to selectively and potently inhibit CSF1R. Vimseltinib has been developed using Deciphera’s proprietary switch-control kinase inhibitor platform. ROMVIMZA (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

About Tenosynovial Giant Cell Tumor (TGCT)

TGCT is caused by a translocation in colony-stimulating factor 1 (CSF1) gene resulting in overexpression of CSF1 and recruitment of colony-stimulating factor 1 receptor (CSF1R)-positive inflammatory cells into the lesion. TGCT is a rare, non-malignant tumor that develops inside or near joints. TGCT is caused by dysregulation of the CSF1 gene leading to overproduction of CSF1. TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS), a diffuse-type of TGCT. TGCT is a locally aggressive neoplasm that can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in diffuse-type TGCT. If untreated or if the tumor continually recurs, damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability. For a subset of patients, surgical resection will potentially cause worsening functional limitation or severe morbidity, systemic treatment options are limited and a new therapeutic option for TGCT is needed.

On July 28, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the successful completion of a $203 million placement to institutional investors ("Placement") (Press release, Clarity Pharmaceuticals, JUL 28, 2025, View Source [SID1234654571]).

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The offer price per new fully paid ordinary share issued under the Placement ("New Share") was $4.20 ("Offer Price"), representing a 2.2% premium to Clarity’s last closing price and an 18.0% premium to the 15-day VWAP. Following the completion of the Placement, the Company will have a pro-forma cash balance of approximately $288 million1, which will help fund Clarity in connection with the below-mentioned expected catalysts and milestones, including the specified clinical trial programs.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The last eight months have been an incredibly tumultuous period for global markets generally, driven by the US political environment. When these times occur, pre-revenue biotechnology companies can be affected significantly more than other businesses due to their need to raise capital in order to get products to market. In addition to the global financial turmoil, there has been some unfortunate news from local biotechnology companies, putting significant pressure on the Australian biotechnology market. Being a successful pre-revenue biotechnology company listed on the ASX also presents additional considerations. For Clarity in particular, the inclusion of the Company in a number of indices over this period, such as the ASX200 and ASX300, has significantly raised the profile of the Company to certain investor groups, including index funds. These factors, amongst other variables, have contributed to the volatility in Clarity’s share price and an increasing number of short positions in our Company, reaching approximately 10% of our current total number of shares on issue.

"However, during this period of volatility our team has not lost sight of our purpose: to better the lives of people living with cancer. This drive has resulted in the achievement of many substantial milestones across our entire business, including outstanding clinical trial data, validation of new products in pre-clinical development, roll-out of enhanced supply and manufacturing in preparation for potential commercialisation and a number of important regulatory objectives.

"The coalescing of strong company fundamentals with ASX investor dynamics provided Clarity with an opportunity to capitalise with a fast, well-executed and sizeable placement to a small number of institutional investors who are close to the Company. The Placement has received phenomenal support, evidenced by the raising of over $200 million at not only a premium to the last closing share price, but a substantial premium to the share price observed for almost the entirety of CY2025. This places Clarity in a strong position, with an enviable Balance Sheet, where we can work to complete a number of high value-driving clinical trials, including our pivotal Phase 3 trials, as we progress our products towards potential commercialisation. The completion of the institutional Placement, coupled with significant short- and medium-term deliverables, such as the read-outs of the Co-PSMA trial and the Phase 3 trials, respectively, as well as longer-term activities, such as the further development of our therapy programs, are expected to underpin short-, medium- and longer-term shareholder value growth as we work towards our ultimate goal of better treating people with cancer."

Bell Potter Securities Limited acted as Sole Lead Manager. Lander & Rogers acted as Clarity’s Australian legal adviser.

UPCOMING EXPECTED CATALYSTS AND MILESTONES
Clinical Development
64Cu-SAR-bisPSMA diagnostic program in prostate cancer

Co-PSMA investigator-initiated trial (head-to-head, biochemical recurrence [BCR]): Readout Q3/4 CY2025
AMPLIFY trial (Phase 3, BCR): Enrolment complete Q4 CY2025
CLARIFY trial (Phase 3, pre-prostatectomy): Enrolment complete H1 CY2026
New Drug Application (NDA) planning and submission activities in anticipation of positive trial results
64/67Cu‑SAR‑bisPSMA theranostic program in prostate cancer

SECuRE (Phase 2, Cohort Expansion): Anticipated enrolment complete by Q1 CY2026
⁶⁴Cu‑SAR‑Bombesin diagnostic program in prostate cancer

Ongoing data review following positive Phase II SABRE topline trial data (June 2025) for prostate-specific membrane antigen (PSMA)-negative prostate cancer
Continued planning for the next trial and possible alternative indications with 64Cu-SAR-Bombesin
64Cu-SARTATE diagnostic program in neuroendocrine tumours (NETs)

Phase 3 trial planning following positive DISCO topline trial data (June 2025): Anticipated End-of-Phase (EOP) meeting with the US Food and Drug Administration (FDA) H2 CY2025
Pipeline Advancements

Pre-clinical development of the theranostic 64/67Cu-SAR-trastuzumab product in breast cancer and the diagnostic 64Cu-SAR-bisFAP product: Complete H1 CY2026
First-in-human trials for both products: Initiate clinical programs H2 CY2026
Continued Strategic Manufacturing Expansion of 64Cu-SAR-bisPSMA

Initial NDA and US commercial supply readiness
Additional agreements established for copper-64 and drug product manufacturing capacity in preparation for proposed commercial launch of 64Cu-SAR-bisPSMA globally: CY2025/6
Global Commercial Team Buildout for 64Cu-SAR-bisPSMA Launch

Hiring of key roles for proposed product launch of 64Cu-SAR-bisPSMA, including Sales, Marketing and Market Access.

On July 28, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the second quarter of 2025, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones (Press release, Exelixis, JUL 28, 2025, View Source [SID1234654573]).

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"Exelixis continued to execute on our corporate objectives in the second quarter of 2025, delivering on key commercial, development and pipeline milestones," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "While early in the launch, we’re very pleased with the reception that CABOMETYX has received in advanced neuroendocrine tumors (NET). Our commercial team rapidly mobilized on the U.S. NET launch following approval in March, capturing a leading share of new patient starts among oral therapies in second-line and later settings with NET representing approximately four percent of our overall CABOMETYX business in the second quarter. We will continue to track the launch trajectory and provide updates to our 2025 full year financial guidance, as appropriate."

Dr. Morrissey continued: "Turning to the zanzalintinib development program, in June, we announced positive topline results from the STELLAR-303 pivotal study in colorectal cancer. We plan to discuss these results with regulators with the intention of filing for approval in this indication as quickly as possible. In May, we completed enrollment into the STELLAR-304 pivotal study in non-clear cell renal cell carcinoma with top-line results expected in the first half of 2026, depending on study event rates. Based on our evaluation of emerging data from the phase 2 portion of the STELLAR-305 study in advanced squamous cell carcinoma of the head and neck, emerging competition in this indication and assessment of other potentially larger commercial opportunities, we have made the decision not to proceed to the phase 3 portion of the trial. We also initiated the STELLAR-311 pivotal study in advanced NET during the quarter and plan to announce an additional wave of zanzalintinib pivotal trials in the coming months. Finally, our early-stage pipeline is advancing quickly with phase 1 clinical studies ongoing for our XL309, XB010 and XB628 programs, and XB371 moving into clinical investigation. As we look ahead to the second half of the year, I’d like to thank the entire Exelixis team for their continued execution across our business, and for their dedication to our mission to help cancer patients recover stronger and live longer."

Second Quarter 2025 Financial Results

Total revenues for the quarter ended June 30, 2025 were $568.3 million, as compared to $637.2 million for the comparable period in 2024.

Total revenues for the quarter ended June 30, 2025 included net product revenues of $520.0 million, as compared to $437.6 million for the comparable period in 2024. The increase in net product revenues was primarily due to an increase in sales volume.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $48.2 million for the quarter ended June 30, 2025, as compared to $199.6 million for the comparable period in 2024. The decrease in collaboration revenues was primarily related to a $150.0 million commercial milestone recognized during the second quarter of 2024 in connection with Ipsen achieving $600 million in cumulative net sales of cabozantinib in its related license territory over four consecutive quarters.

Research and development expenses for the quarter ended June 30, 2025 were $200.4 million, as compared to $211.1 million for the comparable period in 2024. The decrease in research and development expenses was primarily related to decreases in manufacturing costs to support our development candidates and clinical trial costs, partially offset by increases in stock-based compensation, consulting and outside services, and personnel expenses.

Selling, general and administrative expenses for the quarter ended June 30, 2025 were $134.9 million, as compared to $132.0 million for the comparable period in 2024. The increase in selling, general and administrative expenses was primarily related to increases in marketing expenses, stock-based compensation, and personnel expenses, partially offset by a decrease in corporate giving.

Provision for income taxes for the quarter ended June 30, 2025 was $45.6 million, as compared to $66.7 million for the comparable period in 2024.

GAAP net income for the quarter ended June 30, 2025 was $184.8 million, or $0.68 per share, basic and $0.65 per share, diluted, as compared to GAAP net income of $226.1 million, or $0.78 per share, basic and $0.77 per share diluted, for the comparable period in 2024. GAAP net income per share for the quarter ended June 30, 2025 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended June 30, 2025, as compared to the comparable period in 2024, as a result of the stock repurchase programs.

Non-GAAP net income for the quarter ended June 30, 2025 was $212.6 million, or $0.78 per share, basic and $0.75 per share, diluted, as compared to non-GAAP net income of $245.6 million, or $0.85 per share, basic and $0.84 per share diluted, for the comparable period in 2024.

Non-GAAP Financial Measures

To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation, adjusted for the related income tax effect for all periods presented.

Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.

These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

2025 Financial Guidance

Exelixis is maintaining the previously provided financial guidance for fiscal year 2025.

Total revenues

$2.25 billion – $2.35 billion

Net product revenues

$2.05 billion – $2.15 billion(1)

Cost of goods sold

4% – 5% of net product revenues

Research and development expenses

$925 million – $975 million(2)

Selling, general and administrative expenses

$475 million – $525 million(3)

Effective tax rate

21% – 23%

____________________

(1)

Exelixis’ 2025 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 2.8% for CABOMETYX effective Jan. 1, 2025.

(2)

Includes $50.0 million of non-cash stock-based compensation.

(3)

Includes $80.0 million of non-cash stock-based compensation.

Second Quarter 2025 Highlights

Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $520.0 million during the second quarter of 2025, with net product revenues of $517.9 million from CABOMETYX (cabozantinib) and $2.1 million from COMETRIQ (cabozantinib). Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter ended June 30, 2025, Exelixis earned $43.4 million in royalty revenues.

Partner Ipsen Received Approval from the European Commission (EC) for CABOMETYX for Patients with Previously Treated Advanced NET. In July, Exelixis announced that its partner Ipsen received approval from the EC for CABOMETYX for adult patients with unresectable or metastatic, well-differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. This approval follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use in June 2025 and allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union (EU), Norway, Liechtenstein and Iceland. In March, Exelixis received approval from the U.S. Food and Drug Administration (FDA) for CABOMETYX in this setting. These approvals were based on the positive results of the phase 3 CABINET pivotal trial, which evaluated CABOMETYX compared with placebo in two cohorts of patients with previously treated NET: advanced pNET and advanced epNET.

Announcement of Positive Top-line Results from the Phase 3 STELLAR-303 Pivotal Trial Evaluating Zanzalintinib in Combination with an Immune Checkpoint Inhibitor in Patients with Metastatic Colorectal Cancer (CRC). In June, Exelixis announced positive top-line results from the phase 3 STELLAR-303 pivotal trial in which the combination of zanzalintinib with atezolizumab (Tecentriq) demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intent-to-treat (ITT) population. The STELLAR-303 study is evaluating zanzalintinib in combination with atezolizumab versus regorafenib in patients with metastatic, refractory non-microsatellite instability-high or non-mismatch repair-deficient (non-MSI-H/dMMR) CRC. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The top-line findings were from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of the STELLAR-303 phase 3 trial. The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases (non-liver metastases or NLM). The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Exelixis plans to discuss these results with regulators with the intention of filing for approval in this indication as soon as possible. Detailed results will be presented at a future medical meeting.

Presentation of Encouraging Results from Phase 1b/2 STELLAR-002 Trial Evaluating Zanzalintinib in Combination with Immune Checkpoint Inhibitors in Advanced Kidney Cancer at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2025). In June, Exelixis presented results from multiple dose-escalation cohorts of patients with advanced solid tumors, and an expansion cohort of patients with previously untreated advanced clear cell renal cell carcinoma (ccRCC) from the phase 1b/2 STELLAR-002 trial evaluating zanzalintinib in combination with either nivolumab (Opdivo) or a fixed-dose combination of nivolumab and relatlimab (Opdualag) at ASCO (Free ASCO Whitepaper) 2025. The results from the ccRCC expansion cohort demonstrated encouraging activity across all efficacy parameters, including objective response rate (ORR), progression-free survival (PFS) and disease control rates. The findings from the dose-escalation cohorts showed that the toxicity profile of these combinations was manageable and consistent with each agent administered as monotherapy.

Zanzalintinib Pivotal Development Program Updates. Today, Exelixis announced several updates to the zanzalintinib development program, including:

STELLAR-304 study enrollment completed in May 2025. STELLAR-304 is a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell renal cell carcinoma (nccRCC). The primary endpoints in the trial are PFS and ORR. Top-line results are expected in the first half of 2026, depending on study event rates.
Based on the company’s evaluation of emerging data from the phase 2 portion of the STELLAR-305 trial in advanced squamous cell carcinoma of the head and neck (SCCHN), emerging competition in this indication, and assessment of other, potentially larger, commercial opportunities, Exelixis has decided not to proceed to phase 3.
Initiation of the STELLAR-311 phase 3 pivotal trial in advanced NET. STELLAR-311 is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced NET, regardless of site of origin. The primary endpoint of the trial is PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review.
Plans to announce the next wave of zanzalintinib pivotal trials in the coming months.
Preclinical Data Presentations from Four Pipeline Programs in Advanced Cancers at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR 2025). In April, Exelixis presented preclinical data from four pipeline molecules at AACR (Free AACR Whitepaper) 2025. Presentations included data for XL309 and XL495, small molecules that have demonstrated synthetic lethality in the context of certain genetic anomalies found in varying frequencies across a broad array of tumor types. The XL309 findings demonstrated activity of XL309 as monotherapy or in combination with PARP or topoisomerase inhibitors. Data analysis from the XL495 program demonstrated the potential for anti-tumor activity both as monotherapy and in combination with DNA-damaging agents. However, based on early clinical data generated for XL495, Exelixis has discontinued further development of this program. Preclinical data were also presented for the PD-L1 + NKG2A-targeting bispecific antibody XB628 and for the tissue factor (TF)-targeting antibody-drug conjugate (ADC) XB371. Data analysis from the XB628 program demonstrated the molecule’s tumor cell killing activity both in vitro and in vivo, supporting advancement of this molecule into clinical development. Findings from XB371 non-clinical experiments demonstrated potent anti-tumor activity in vivo across a range of human tumor xenograft models including colorectal, lung, and pancreatic cancers, supporting the molecule’s advancement into phase 1 clinical development.

Advancement of XB628 and XB371 Pipeline Programs into Clinical Development. Today, Exelixis provided an update on the recent progress of its early-stage pipeline programs, including XB628 (PD-L1 + NKG2A-targeting bispecific antibody) and XB371 (TF-targeting ADC). In April, Exelixis initiated the phase 1 study of XB628, following the U.S. FDA clearance of its Investigational New Drug (IND) application in March. Exelixis now has three ongoing phase 1 trials for its pipeline programs XL309, XB010 and XB628. Additionally, in July, the U.S. FDA cleared Exelixis’ IND application for XB371 and the company plans to initiate the phase 1 study in the coming months.

Federal Income Tax Impact from the One Big Beautiful Bill Act. On July 4, 2025, the One Big Beautiful Bill Act was signed into law which, among other provisions, permanently repeals the requirement to capitalize domestic research and experimental (R&E) expenditures for federal income tax purposes for taxable years beginning after December 31, 2024, and allows for the accelerated deduction of any remaining unamortized domestic R&E expenditures. Foreign R&E expenditures are still required to be capitalized and amortized ratably over 15 years. Exelixis estimates its federal cash tax benefit for previously unamortized domestic R&E expenditures is $147 million with no corresponding impact to the federal income tax provision.

Positive Developments Across Cabozantinib Patent Estate. Today, Exelixis announced recent positive developments with regards to the company’s defense of its cabozantinib patent estate. First, in June and July 2025, the United States Patent and Trademark Office (USPTO) declined to institute Azurity Pharmaceuticals’ petitions for inter partes review (IPRs) of U.S. Patent Nos. 11,298,349 and 12,128,039, respectively. Second, in July 2025, Exelixis entered into a settlement agreement with Biocon Pharma Limited, which resolved the patent litigation Exelixis brought in response to Biocon’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of CABOMETYX prior to the expiration of the applicable patents. Pursuant to the terms of the agreement, Exelixis will grant Biocon a license to market its generic version of CABOMETYX in the U.S. beginning on January 1, 2031, if approved by the FDA and subject to conditions and exceptions common to agreements of this type.

Stock Repurchase Program. In August 2024, Exelixis’ Board of Directors authorized a stock repurchase program to acquire up to $500 million of the company’s common stock before December 31, 2025. In February 2025, the Board of Directors authorized the repurchase of up to an additional $500 million of the company’s common stock before December 31, 2025. Under these programs, as of June 30, 2025, Exelixis has repurchased $796.3 million of the company’s common stock, at an average price of $36.69 per share. Since the approval of the first stock repurchase program in March 2023, the weighted-average diluted common shares outstanding has decreased from 326.3 million shares to 284.4 million shares as of June 30, 2025. Stock repurchases under these programs may be made from time to time through a variety of methods, which may include open market purchases, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any stock repurchases under the stock repurchase programs will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions.

Basis of Presentation

Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended July 4, 2025 and June 28, 2024, are indicated as being as of and for the periods ended June 30, 2025 and June 30, 2024.

Conference Call and Webcast

Exelixis management will discuss the company’s financial results for the second quarter 2025 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Monday, July 28, 2025.

To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on www.exelixis.com for one year.