On November 1, 2022 McKesson Corporation (NYSE:MCK) reported results for the second-quarter ended September 30, 2022 (Press release, McKesson, NOV 1, 2022, View Source [SID1234622696]).

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"Our financial results for the second quarter demonstrate how the continued development of our strategy, operating execution, and talented teams are driving solid growth. This performance enables further investments in both our oncology and biopharma businesses, which are foundations for our ability to deliver long term shareholder value," said Brian Tyler, chief executive officer. "McKesson continues to advance as a diversified healthcare services leader. Our expanding capabilities, combined with continued execution, give us the confidence in our outlook, and as a result, we are raising our guidance for fiscal 2023 Adjusted Earnings per Diluted Share to $24.45 to $24.95."

Second-quarter revenues were $70.2 billion, an increase of 5% from a year ago, primarily driven by growth in the U.S. Pharmaceutical segment, resulting from increased specialty product volumes, including retail national account customers, and market growth, partially offset by lower revenues in the International segment as a result of the progress on the planned divestiture of McKesson’s European business.

Second-quarter earnings per diluted share from continuing operations was $6.46 compared to $1.71 a year ago, an increase of $4.75.

Second-quarter Adjusted Earnings per Diluted Share was $6.06 compared to $6.15 a year ago, a decrease of 1%, driven by prior year net gains from McKesson Ventures’ equity investments and lower contribution from the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs and COVID-19 tests, partially offset by a lower share count. Second-quarter Adjusted Earnings per Diluted Share included pre-tax net losses of approximately $3 million associated with McKesson Ventures’ equity investments, compared to pre-tax net gains of approximately $97 million in the second-quarter of fiscal 2022.

For the first six months of the fiscal year, McKesson returned $1.6 billion of cash to shareholders, which included $1.5 billion of common stock repurchases and $139 million of dividend payments. During the first six months of the fiscal year, McKesson generated cash from operations of $166 million, and invested $222 million in capital expenditures, resulting in negative Free Cash Flow of $56 million.

Business Highlights

McKesson signed an agreement in principle to extend its pharmaceutical distribution partnership with CVS Health through June 2027.
McKesson continues to expand its differentiated oncology and biopharma businesses, further demonstrating meaningful progress against its company priorities.
On October 31, 2022, McKesson and HCA Healthcare completed its transaction and formed a joint venture combining McKesson’s US Oncology Research and HCA Healthcare’s Sarah Cannon Research Institute to advance cancer care and increase access to oncology clinical research. McKesson also acquired Genospace, a leading innovator in precision medicine and clinical trial matching.
On November 1, 2022, McKesson closed the transaction of Rx Savings Solutions (RxSS), a prescription price transparency and benefit insight company that offers affordability and adherence solutions to health plans and employers.
McKesson progressed in its planned exit of business operations within the European region and has completed divestitures in 11 of the 12 countries. After entering into an agreement in July 2021 to sell certain McKesson Europe businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX Group, McKesson closed the transaction on October 31, 2022.
U.S. Pharmaceutical Segment

Second-quarter revenues were $60.1 billion, an increase of 12%, driven by increased volume of specialty products, including higher volumes from retail national account customers, and market growth, partially offset by branded to generic conversions.
Second-quarter Segment Operating Profit was $896 million. Adjusted Segment Operating Profit was $756 million, an increase of 3%, driven by growth in distribution of specialty products to providers and health systems, partially offset by lower demand of COVID-19 vaccine distribution. Excluding the impact of COVID-19 vaccine distribution, the U.S. Pharmaceutical segment delivered Adjusted Segment Operating Profit growth of 5%.
Prescription Technology Solutions Segment

Second-quarter revenues were $1.0 billion, an increase of 9%, driven by growth in prescription volumes in our third-party logistics business and higher technology service revenues.
Second-quarter Segment Operating Profit was $120 million. Adjusted Segment Operating Profit was $141 million, a decrease of 2%, driven by higher operating expenses, resulting from increased headcount associated with annual support of customer programs.
Medical-Surgical Solutions Segment

Second-quarter revenues were $2.8 billion, a decrease of 9%, driven by lower sales of COVID-19 tests, partially offset by growth in the primary care business.
Second-quarter Segment Operating Profit was $299 million. Adjusted Segment Operating Profit was $307 million, a decrease of 4%, driven by lower sales of COVID-19 tests, partially offset by organic business performance. Excluding the impact of COVID-19 related items, the Medical-Surgical Solutions segment delivered Adjusted Segment Operating Profit growth of 7%.
International Segment

Second-quarter revenues were $6.2 billion. On an FX-Adjusted basis, revenues were $6.9 billion, a decrease of 25%, driven by the divestitures of McKesson’s UK and Austrian businesses.
Second-quarter Segment Operating Loss was $37 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $151 million, a decrease of 7%, driven by the divestitures of McKesson’s UK and Austrian businesses.
Company Updates

Kathleen Wilson-Thompson, a member of McKesson’s independent Directors, was recognized with the Distinguished Alumna Award by the DirectWomen Organization for her leadership and contributions to board service.
Brian Tyler signed the Disability:IN’s "CEO Letter on Disability Inclusion," reaffirming McKesson’s commitment to create an inclusive workplace for its employees.
Fiscal 2023 Outlook

McKesson raised fiscal 2023 Adjusted Earnings per Diluted Share guidance to $24.45 to $24.95 from the previous range of $23.95 to $24.65 to reflect operating business performance and increased contribution from the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs and COVID-19 tests.

Fiscal 2023 Adjusted Earnings per Diluted Share guidance includes approximately $1.45 to $1.65 of impacts attributable to the following:

Fiscal 2023 Adjusted Earnings per Diluted Share guidance indicates 11% to 14% forecasted growth compared to prior year, excluding the impacts of the above items from both fiscal 2023 guidance and fiscal 2022 results.

Additional modeling considerations will be provided in the earnings call presentation.

Conference Call Details

McKesson has scheduled a conference call for today, Tuesday, November 1st at 4:30 PM ET to discuss the company’s financial results. The audio webcast of the conference call will be available live and archived on McKesson’s Investor Relations website at investor.mckesson.com.

Upcoming Investor Events

McKesson management will be participating in the following investor conference:

J.P. Morgan Healthcare Conference, January 9-12, 2023
Audio webcast, and a complete listing of upcoming events for the investment community, including details and updates, will be available on McKesson’s Investor Relations website.

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted Loss on Debt Extinguishment, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The Company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, certain litigation loss and gain contingencies, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

On November 1, 2022 Exelixis, Inc. (Nasdaq: EXEL) and Cybrexa Therapeutics (Cybrexa) reported that the companies have entered into an exclusive collaboration agreement providing Exelixis the right to acquire CBX-12 (alphalex exatecan), a clinical-stage, first-in-class peptide-drug conjugate (PDC) that utilizes Cybrexa’s proprietary alphalex technology to enhance delivery of exatecan to tumor cells (Press release, Exelixis, NOV 1, 2022, View Source [SID1234622695]). CBX-12 is designed to increase the efficacy and reduce the toxicity of topoisomerase I inhibition by delivering exatecan, a highly potent, second-generation topoisomerase I inhibitor, directly to the tumor cells. This collaboration underscores Exelixis’ commitment to expanding its clinical pipeline building upon its biotherapeutics and targeted drug therapy expertise.

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CBX-12 is composed of a pH-Low Insertion Peptide (pHLIP), a linker and exatecan. As an antigen-independent therapy, CBX-12 may have broad utility in patients who are not eligible for antigen-targeted therapies, including monoclonal antibodies and antibody-drug conjugates (ADCs), and has potential for use in combination regimens with other anti-cancer agents and immunotherapies. Data from the ongoing phase 1 trial of CBX-12 in patients with metastatic solid tumors, reported in an oral presentation during a plenary session at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) 2022 Symposium on October 28, 2022, demonstrated preliminary anti-tumor activity in a heavily pretreated patient population. This included a complete response in a patient with ovarian cancer.

"This agreement aligns with Exelixis’ goal of acquiring first- or best-in-class clinical-stage assets that may provide differentiated benefits to patients with cancer. Today’s announcement further highlights our ongoing strategy to leverage our balance sheet to gain access to new assets with compelling potential upside in a risk-sharing model, where we can work with partners to further establish proof of concept before investing more heavily," said Michael Morrissey, Ph.D., President & CEO, Exelixis. "Robust preclinical data and initial clinical data from the ongoing phase 1 trial suggest that CBX-12 may provide differentiated clinical benefit in several solid tumors. Similar to our interest in antibody-drug conjugates, we believe this novel peptide-drug conjugate has transformative clinical potential, and this collaboration affords us the opportunity to expand our clinical pipeline with a best-in-class exatecan therapy if additional CBX-12 clinical data demonstrate enhanced safety and efficacy."

Cybrexa’s proprietary alphalex technology is designed to increase the therapeutic index of potent anti-cancer compounds by targeting their delivery to tumor cells, thus reducing systemic exposure and thereby reducing toxicity. Importantly, this targeting is achieved through an antigen-independent mechanism, making the alphalex technology potentially applicable to diverse tumor types and providing a complementary approach to traditional ADCs. The alphalex technology platform utilizes pHLIPs combined with a linker to deliver anti-cancer compounds directly to tumor cells. In the acidic (low pH) tumor microenvironment, the pHLIP forms an alpha-helical structure that inserts itself into and across the tumor cell membrane. It is well established that many tumors have an altered metabolism that results in excretion of lactic acid into the tumor microenvironment, thereby reducing the local pH. The linker is cleaved within the cell, releasing the anti-cancer agent into the cell’s cytoplasm. The alpha-helical structure of the peptide (pHLIP) does not form in the physiologic pH surrounding normal cells, preventing delivery to these cells and reducing toxicity.

"Cybrexa is focused on developing the next generation of cancer therapeutics that specifically target tumors and their underlying biology," said Per Hellsund, President & CEO, Cybrexa. "With its expanding portfolio of biotherapeutics, including ADCs, Exelixis and its partner network have significant and expanding expertise in PDC chemistries and development. Our alphalex PDC technology is an important complement to ADCs and other targeted therapies, and we are excited to bring Exelixis’ insights and resources to the development of CBX-12."

Financial Considerations

Under the terms of the agreement, Exelixis will pay Cybrexa an upfront fee of $60 million in exchange for the right to acquire CBX-12 pending certain Phase 1 results and to fund certain development and manufacturing expenses incurred by Cybrexa to advance an agreed development plan. Cybrexa may also be eligible to receive up to an additional $642.5 million, including development, regulatory, and commercial milestone payments, as well as a fee for the acquisition of CBX-12 upon evaluation of a pre-specified clinical data package.

Please see Exelixis’ disclosure in today’s Form 10-Q filed with the Securities and Exchange Commission for additional details of the terms of the collaboration agreement.

About the alphalex Technology Platform

The Cybrexa alphalex technology is a novel antigen-independent peptide-drug conjugate (PDC) platform that enables targeted delivery of highly potent anticancer treatments and aims to revolutionize the standard of care in oncology. The platform consists of a pH-Low Insertion Peptides (pHLIPs) peptide, linker, and small molecule anti-cancer agent. pHLIP peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc., and Cybrexa is a sublicensee of pHLIP, Inc.

On November 1, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers, reported that it will report financial results for the third quarter 2022 on Monday, November 7, 2022, after market close (Press release, Revolution Medicines, NOV 1, 2022, View Source [SID1234622694]). At 4:30 p.m. Eastern Time that day (1:30 p.m. Pacific Time), Revolution Medicines’ senior management team will host a webcast to discuss the financial results for the quarter and provide an update on corporate progress.

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To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

On November 1, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the third quarter of 2022 and provided an update on progress toward achieving key corporate objectives, as well as commercial, clinical and pipeline development milestones (Press release, Exelixis, NOV 1, 2022, View Source [SID1234622693]).

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"Exelixis focused its efforts toward the progress and expansion of our clinical and early-stage pipeline during the third quarter of 2022, fueled by the growing revenues from our cabozantinib franchise," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "The team continued to drive strong commercial performance for cabozantinib, resulting in 39 percent year-over-year net product revenue growth for our flagship franchise. The team was also highly active on the business development front evaluating various opportunities and executing on multiple deals, including new option deals with Cybrexa and Sairopa announced today, which highlight our strategic efforts to access clinical- or near-clinical-stage assets that have the potential to be first- or best-in-class medicines and may provide differentiated benefits to patients with cancer."

Dr. Morrissey continued: "In addition, we achieved key clinical milestones, including presenting detailed results from our pivotal COSMIC-313 clinical trial and dose-escalation data from the phase 1b STELLAR-001 trial of XL092 at the ESMO (Free ESMO Whitepaper) 2022 Congress, as well as sharing the first clinical update from our phase 1 XB002 tissue factor ADC program at the 34th ENA Symposium in October. I’d like to thank the entire Exelixis team for their continued hard work and dedication in the third quarter as we made significant progress in commitment of the patients we serve."

Third Quarter 2022 Financial Results

Total revenues for the quarter ended September 30, 2022 were $411.7 million, as compared to $328.4 million for the comparable period in 2021.

Total revenues for the quarter ended September 30, 2022 included net product revenues of $366.5 million, as compared to $263.1 million for the comparable period in 2021. The increase in net product revenues was primarily due to an increase in sales volume, which was partially offset by increases in discounts and allowances, primarily from an increase in chargebacks related to the 340B Drug Pricing Program.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $45.3 million for the quarter ended September 30, 2022, as compared to $65.3 million for the comparable period in 2021. The decrease in collaboration revenues was primarily related to decreases in the recognition of milestone-related revenues and development cost reimbursements earned, which was partially offset by higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partners, Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda).

Research and development expenses for the quarter ended September 30, 2022 were $198.8 million, as compared to $163.4 million for the comparable period in 2021. The increase in research and development expenses were primarily related to increases in clinical trial costs, personnel expenses, consulting and outside services expenses, and stock-based compensation expense, which were partially offset by a decrease in other development costs.

Selling, general and administrative expenses for the quarter ended September 30, 2022 were $115.0 million, as compared to $101.6 million for the comparable period in 2021. The increase in selling, general and administrative expenses was primarily related to increases in personnel expenses, business technology initiatives, and rent and utilities expenses.

Provision for income taxes for the quarter ended September 30, 2022 was $18.8 million, as compared to $15.1 million for the comparable period in 2021, primarily due to an increase in pre-tax income.

GAAP net income for the quarter ended September 30, 2022 was $73.2 million, or $0.23 per share, basic and diluted, as compared to GAAP net income of $38.2 million, or $0.12 per share, basic and diluted, for the comparable period in 2021.

Non-GAAP net income for the quarter ended September 30, 2022 was $102.0 million, or $0.32 per share, basic and $0.31 per share, diluted, as compared to non-GAAP net income of $64.5 million, or $0.20 per share, basic and diluted, for the comparable period in 2021.

Cash, cash equivalents, restricted cash equivalents and investments were $2.1 billion at September 30, 2022, as compared to $1.9 billion at December 31, 2021.

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 expense, 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 expense, 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.

2022 Financial Guidance

Exelixis is providing the following updated financial guidance for fiscal year 2022:

Total revenues

$1.575 billion – $1.600 billion

Net product revenues

$1.375 billion – $1.400 billion

Cost of goods sold

~5% of net product revenues

Research and development expenses (1)

$875 million – $900 million

Selling, general and administrative expenses (2)

$450 million – $475 million

Effective tax rate

20% – 22%

(1)

Includes $45 million of non-cash stock-based compensation expense.

(2)

Includes $60 million of non-cash stock-based compensation expense.

Cabozantinib Highlights

Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $366.5 million during the third quarter of 2022, up 6% over the prior quarter, comprised of net product revenues of $361.4 million from CABOMETYX (cabozantinib) and $5.1 million from COMETRIQ (cabozantinib). In the third quarter of 2022, global cabozantinib franchise net product revenues generated by Exelixis and its partners were almost $500 million. Exelixis earned $30.3 million in royalty revenues during the quarter ended September 30, 2022, pursuant to collaboration agreements with its partners, Ipsen and Takeda.

Detailed Results from Phase 3 COSMIC-313 Pivotal Trial in Patients with Previously Untreated Advanced Renal Cell Carcinoma (RCC) Presented at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. In September, Exelixis presented detailed results from the pivotal phase 3 COSMIC-313 trial evaluating the triplet combination of cabozantinib, nivolumab and ipilimumab versus the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk RCC, at the 2022 ESMO (Free ESMO Whitepaper) Congress. The data included detailed results of the primary endpoint of progression-free survival (PFS) demonstrating a positive PFS benefit for the triplet combination of cabozantinib, nivolumab and ipilimumab compared to the combination of nivolumab and ipilimumab, as well as encouraging objective response rates in the PFS intent-to-treat population. The safety profile observed in the trial was reflective of the known safety profiles for each single agent as well as the combination regimens used in this study. Previously, in July, Exelixis announced that COSMIC-313 met its primary endpoint, demonstrating significant improvement in PFS at the primary analysis. At a prespecified interim analysis for the secondary endpoint of overall survival (OS), the combination of cabozantinib, nivolumab and ipilimumab did not demonstrate a significant benefit over the combination of nivolumab and ipilimumab. Therefore, the trial will continue to the next analysis of OS.

Pipeline Highlights

Presentation of Dose-Escalation Results from Phase 1b STELLAR-001 Trial Evaluating XL092 Monotherapy and in Combination with Atezolizumab in Patients with Advanced Solid Tumors at the 2022 ESMO (Free ESMO Whitepaper) Congress. In September, Exelixis presented results from the dose-escalation stage of STELLAR-001, an ongoing phase 1b trial evaluating XL092 as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. The data showed that XL092 demonstrated preliminary clinical activity similar to that observed with cabozantinib in phase 1 across a range of solid tumors and dose levels, with a manageable safety profile. Of note, both single-agent XL092 and XL092 in combination with atezolizumab demonstrated encouraging efficacy and safety in a heavily pretreated patient population, including clear cell RCC patients previously treated with cabozantinib. Tumor reduction was seen in a majority of patients along with a high disease control rate. The maximum tolerated dose was determined to be 120 mg, and the recommended dose for the expansion stage is 100 mg for both single-agent XL092 and XL092 in combination with atezolizumab. The cohort-expansion stage of the study is currently ongoing and enrolling patients across multiple solid tumor types.

Expanded Clinical Trial Collaboration and Supply Agreement with Bristol-Myers Squibb (BMS) to Include Fixed-Dose Combination of Nivolumab and Relatlimab in Combination with XL092 in Phase 1b STELLAR-002 Trial. In October, Exelixis announced the expansion of its June 2021 Clinical Trial Collaboration and Supply Agreement with BMS to include the use of the fixed-dose combination of nivolumab and relatlimab in the ongoing phase 1b STELLAR-002 clinical trial, which is evaluating XL092 in combination with multiple immune checkpoint inhibitors in advanced solid tumors. Relatlimab is a lymphocyte activation gene-3 (LAG-3)-blocking antibody. LAG-3 is an inhibitory immune checkpoint expressed on the surface of T-cells. The STELLAR-002 trial is divided into two parts: a dose-escalation stage and a cohort-expansion stage. Enrollment and dosing in the dose-escalation portion of STELLAR-002 is ongoing. The dose-escalation stage will determine the recommended dose in patients with advanced solid tumors for each of the combination therapy regimens, including: XL092 and nivolumab; XL092, nivolumab and ipilimumab; and XL092 and the fixed-dose combination of nivolumab and relatlimab. The novel triplet combination of XL092 and the fixed-dose combination of nivolumab and relatlimab has the potential to be used in multiple expansion cohorts.

Presentation of Initial Dose-Escalation Results from the First-in-Human Phase 1 JEWEL-101 Trial Evaluating XB002 in Patients with Advanced Solid Tumors at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium. In October, Exelixis presented promising initial results from the ongoing dose-escalation stage of JEWEL-101, a phase 1 study evaluating Exelixis’ XB002 next-generation tissue factor targeting antibody-drug conjugate (ADC), at the 34th ENA Symposium. The data demonstrated that XB002 was well-tolerated across multiple dose levels, with no dose-limiting toxicities observed as of the data cutoff. A pharmacokinetic analysis demonstrated that XB002 exposure increased more than or proportionately to dose increases. XB002 total antibody and intact ADC pharmacokinetics were similar, suggesting XB002 is stable after infusion. Consistent with this, levels of free circulating payload remained low at all dose levels. JEWEL-101 is enrolling patients with advanced solid tumors for which therapies are unavailable, ineffective or intolerable. The dose-escalation stage of the study is currently ongoing and will progress to the cohort-expansion stage once the recommended dose and/or maximum tolerated dose for XB002 have been determined. In the upcoming cohort-expansion stage, the efficacy of XB002 will be further evaluated as a single agent and in combination with nivolumab.

Corporate Updates

Exclusive License Agreement with Ryvu Therapeutics S.A. (Ryvu) to Develop Novel STING Agonist-Based Targeted Cancer Therapies. In July, Exelixis and Ryvu announced an exclusive license agreement focused on the development of novel targeted therapies utilizing Ryvu’s STING (STimulator of INterferon Genes) technology. The collaboration is intended to expand Exelixis’ portfolio of biotherapeutics by combining its tumor-specific targeting approaches with Ryvu’s proprietary small molecule STING agonists and STING biology know-how. Under the terms of the agreement, Exelixis paid Ryvu an upfront fee of $3.0 million in exchange for certain rights to Ryvu’s STING agonist small molecules, which Exelixis will seek to incorporate into targeted therapies such as ADCs. Exelixis will lead all research activities and, upon selection of each development candidate, will be responsible for all development and commercialization activities. Ryvu will provide expert guidance and know-how during the early research phase of the partnership.

Basis of Presentation

Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal period ended October 1, 2021, is indicated as being as of and for the period ended September 30, 2021.

Conference Call and Webcast

Exelixis management will discuss the company’s financial results for the third quarter of 2022 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, November 1, 2022.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 888-338-9509 (domestic) or 412-902-4281 (international) and ask to be joined into the Exelixis conference call to participate by phone.

A telephone replay will be available until 8:00 p.m. ET on Thursday, November 3, 2022. Access numbers for the telephone replay are: 877-344-7529 (domestic) and 412-317-0088 (international); the passcode is 6992264. A webcast replay will also be archived on www.exelixis.com for one year.

On November 1, 2022 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that the company will host a conference call and live webcast on Tuesday, November 8, 2022 at 4:30 p.m. ET to report third quarter 2022 financial results and discuss recent business highlights (Press release, Heron Therapeutics, NOV 1, 2022, View Source [SID1234622692]).

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The conference call can be accessed by dialing (646) 307-1963 for domestic callers and (800) 715-9871 for international callers. Please provide the operator with the passcode 4433557 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for 60 days following the call.