On November 1, 2023 MEI Pharma, Inc. (NASDAQ: MEIP) (the "Company") and Anson Funds and Cable Car Capital ("Anson and Cable Car") reported that they have entered into a cooperation agreement (Press release, MEI Pharma, NOV 1, 2023, View Source [SID1234636645]). Key terms of the agreement include:

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Capital Return to Stockholders: The Company intends to promptly pay a dividend in the amount of $1.75 per share of common stock to all stockholders.

Additionally, a second return of capital of approximately $9.33 million in the aggregate will be authorized by the Board if either (i) at least 17 patients in Cohort 1 of the Company’s ongoing ME-344 phase 1b study have disease progression prior to week 16 of treatment (a threshold consistent with the bar set forth in the phase 1b clinical trial protocol needed to continue the study by enrolling Cohort 2 of the phase 1b study), or (ii) at least six months after the date of the cooperation agreement, and prior to the initiation of Cohort 2 of the phase 1b study, the Company’s Board determines not to proceed with Cohort 2. This second return of capital may take the form of a dividend or tender offer, will be subject to the proper exercise by the Board of its fiduciary duties under applicable law and is subject to modification to the extent necessary to comply with appliable requirements under Delaware law.

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Stockholder Designees Added to the Board: The Company has appointed two directors designated by Anson and Cable Car: Mr. James Flynn and Mr. Taheer Datoo. Additionally, Mr. Steven Wood, as mutually agreed upon by the Company and Anson and Cable Car, has been appointed as an additional MEI stockholder representative designated by the Board. These appointments are effective immediately and the new directors will be nominated for election by the Company in connection with the upcoming fiscal 2024 Annual Meeting of Stockholders ("2024 Annual Meeting"), to serve for a three-year term if elected.

Current MEI directors Daniel P. Gold, Ph.D., Tamar D. Howson and Sujay R. Kango have resigned from the Board concurrently with the execution of the cooperation agreement and will not seek reelection at the 2024 Annual Meeting. Assuming all directors nominated by the Board are elected at the 2024 Annual Meeting, the Board will continue to comprise eight directors, six of whom will be independent pursuant to the applicable stock exchange listing standards.

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Formation of a Capital Allocation Committee: MEI’s Board has formed a Capital Allocation Committee, comprising five directors including the three new directors. The Capital Allocation Committee will advise the full Board on the Company’s strategic allocation of capital to support (i) the development of its drug candidate programs and (ii) other value creation or preservation measures, with a view toward maximizing stockholder value.

Additionally, as part of the cooperation agreement, Anson and Cable Car have agreed to withdraw their consent solicitation and will vote for the Company’s slate of director nominees in connection with the 2024 Annual Meeting and the fiscal 2025 Annual Meeting of Stockholders. Anson and Cable Car will also abide by customary standstill provisions.

"Today’s announcement reflects our ongoing engagement with our stockholders, and we are pleased to reach an agreement that we believe is in the best interest of all stockholders," said David M. Urso, president and chief executive officer of MEI Pharma. "This agreement enables MEI to support stockholder value by returning capital via a near-term cash dividend, with the potential for additional capital return, while allowing us to devote resources to advance our two promising programs, voruciclib and ME-344, through key upcoming data readouts – and avoid the costs associated with a consent solicitation and proxy contest. With important near-term data expected during the first half of 2024, we remain focused on executing our development programs and the potential to deliver differentiated and improved therapeutic options to cancer patients."

"We believe that MEI has the opportunity to create value for stockholders by advancing its programs and judiciously returning capital to stockholders – and the agreement we reached today is a positive step forward for MEI stockholders," said Moez Kassam of Anson Funds and Jacob Ma-Weaver of Cable Car. "We are pleased to reach this constructive resolution that we believe will add important perspectives to the Board and ensure the Company is best positioned to maximize value for stockholders."

The complete agreement will be included as an exhibit to a Current Report on Form 8-K, which will be filed with the Securities and Exchange Commission ("SEC").

On November 1, 2023 McKesson Corporation (NYSE:MCK) reported results for the second quarter ended September 30, 2023 (Press release, McKesson, NOV 1, 2023, View Source [SID1234636644]).

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Fiscal 2024 Second Quarter Result Summary
Second Quarter
Year-to-Date
($ in millions, except per share amounts) FY24 FY23 Change FY24 FY23 Change
Revenues $ 77,215 $ 70,157 10 % $ 151,698 $ 137,311 10 %
Income from Continuing Operations 2
664 932 (29) 1,622 1,698 (4)
Adjusted Earnings 2,3
841 874 (4) 1,834 1,725 6
Earnings per Diluted Share 2
4.92 6.46 (24) 11.95 11.71 2
Adjusted Earnings per Diluted Share 2,3
6.23 6.06 3 13.51 11.89 14
1 See below under "Fiscal 2024 Outlook" for full explanation
2 Reflects continuing operations attributable to McKesson, net of tax
3 Adjusted results in this earnings release are non-GAAP financial measures; refer to the accompanying definitions, reconciliation schedules, and schedule 2

"McKesson delivered second quarter results above expectations, demonstrating continued progress against our company priorities," said Brian Tyler, chief executive officer. "This performance and continued momentum reflect the dedication and contribution of our McKesson team members. The continued strength of our differentiated capabilities in our oncology and biopharma services platforms positions McKesson to deliver sustainable growth and compelling long-term shareholder value. As a result of our first half performance and outlook for the remainder of the year, we are raising our guidance range for fiscal 2024 Adjusted Earnings per Diluted Share to $26.80 to $27.40."

Second quarter revenues were $77.2 billion, an increase of 10% from a year ago. Revenue increases were primarily driven by growth in the U.S. Pharmaceutical segment, resulting from increased prescription volumes, including higher volumes from retail national account customers, specialty products, and GLP-1 medications, partially offset by lower revenues in the International segment as a result of the divestitures of McKesson’s European businesses.

Second quarter earnings per diluted share from continuing operations was $4.92 compared to $6.46 a year ago, a decrease of $1.54, which includes a pre-tax provision for bad debts of $210 million within the U.S. Pharmaceutical segment for uncollected trade accounts receivable related to the bankruptcy of Rite Aid Corporation.

Second quarter Adjusted Earnings per Diluted Share was $6.23 compared to $6.06 a year ago, an increase of 3%, driven by a lower share count and growth in the Prescription Technology Solutions and U.S. Pharmaceutical segments, partially offset by a higher tax rate. Second quarter Adjusted Earnings per Diluted Share also included pre-tax losses of approximately $10 million associated with McKesson Ventures’ equity investments, compared to pre-tax losses of approximately $3 million in the second quarter of fiscal 2023.

For the first six months of the fiscal year, McKesson returned $1.7 billion of cash to shareholders, which included $1.5 billion of common stock repurchases and $149 million of dividend payments. During the first six months of the fiscal year, McKesson used cash from operations of $87 million, and invested $264 million in capital expenditures, resulting in negative Free Cash Flow of $351 million.

Business Highlights
•Ontada was awarded a contract with the U.S. Food and Drug Administration to advance the use of real-world data in the U.S. community oncology setting. The research aims to strengthen the scientific understanding of the natural history of rare cancers by leveraging Ontada’s community oncology footprint, unique real-world data, and experience in real-world research.
•McKesson received two awards and recognitions exemplifying its commitment to diversity and inclusion.
◦Named "Best Place to Work for Disability Inclusion" for the eighth consecutive year. McKesson earned a top-ranking score of 100 on the 2023 Disability Equality Index, a joint initiative of the American Association of People with Disabilities and Disability:IN.
◦Recognized by Forbes as one of America’s Best Employers for Women," demonstrating its outstanding progress in promoting gender equality and diversity in the workplace.

Executive Leadership Transition
•Lori Schechter, Executive Vice President, Chief Legal Officer & General Counsel, has made the decision to retire from McKesson in June 2024. On January 1, 2024, Lori will assume the role of Board and Enterprise Risk Advisor and step down as an Executive Officer of the company, a role she has held since June 2014.
•With Lori’s decision to retire, we are also announcing the appointment of Michele Lau as Executive Vice President and Chief Legal Officer, effective January 1, 2024. For the past two and a half years, Michele has served as Chief Legal Officer & Corporate Secretary for GoDaddy. Prior to that role, Michele spent thirteen years as a member of McKesson’s General Counsel Organization, most recently as Senior Vice President, Corporate Secretary & Associate General Counsel.

U.S. Pharmaceutical Segment
•Revenues were $69.8 billion, an increase of 16%, driven by increased prescription volumes, including higher volumes from retail national account customers, specialty products, and GLP-1 medications, partially offset by branded to generic conversions.
•Segment Operating Profit was $593 million. Adjusted Segment Operating Profit was $815 million, an increase of 8%, driven by growth in the distribution of specialty products to providers and health systems and increased contributions from our generics program. Excluding the impact of COVID-19 vaccine distribution from fiscal 2023, the U.S. Pharmaceutical segment delivered Adjusted Segment Operating Profit growth of 15%.

Prescription Technology Solutions Segment
•Revenues were $1.1 billion, an increase of 12%, driven by increased prescription volumes in our technology services and third-party logistics businesses.
•Segment Operating Profit was $238 million. Adjusted Segment Operating Profit was $209 million, an increase of 48%, driven by higher demand for access solutions, primarily related to prior authorization services due to increased prescription volumes.

Medical-Surgical Solutions Segment
•Revenues were $2.8 billion, flat to the prior year, driven by lower sales of COVID-19 tests and lower contribution from kitting, storage, and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program.
•Segment Operating Profit was $244 million. Adjusted Segment Operating Profit was $254 million, a decrease of 17%, driven by lower contribution from kitting, storage, and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program and lower sales of COVID-19 tests. Excluding the impact of COVID-19 related items from fiscal 2023, the Medical-Surgical Solutions segment delivered Adjusted Segment Operating Profit growth of 5%, driven by growth in the extended care business due to increased volumes of nutritional supplements.

International Segment
•Revenues were $3.5 billion. On an FX-Adjusted basis, revenues were $3.6 billion, a decrease of 43%, driven by the divestitures of McKesson’s European businesses.
•Segment Operating Profit was $66 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $93 million, a decrease of 32%, driven by the divestitures of McKesson’s European businesses.

Fiscal 2024 Outlook
McKesson does not provide forward-looking guidance on a GAAP basis as the Company is unable to provide a quantitative reconciliation of forward-looking Non-GAAP measures to the most directly comparable forward-looking GAAP measure, without unreasonable effort. 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 generally 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.

McKesson is raising fiscal 2024 Adjusted Earnings per Diluted Share guidance to $26.80 to $27.40 from the previous range of $26.55 to $27.35 to reflect solid operating business performance.

Fiscal 2024 Adjusted Earnings per Diluted Share guidance includes ($0.10) related to year-to-date losses associated with McKesson Ventures’ equity investments. Fiscal 2024 Adjusted Earnings per Diluted Share Excluding Certain Items guidance indicates 14% to 17% forecasted growth compared to prior year.

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

Conference Call Details
McKesson has scheduled a conference call for today, Wednesday, 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.

On November 1, 2023 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the third quarter ended September 30, 2023, along with recent company developments (Press release, TG Therapeutics, NOV 1, 2023, View Source [SID1234636642]).

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "The team has executed very well in the third quarter, making significant progress on our corporate goals and continuing to build a solid foundation for the BRIUMVI launch. We showed strong net quarterly revenue of approximately $166 million, including an upfront milestone payment from our ex-U.S. partner, Neuraxpharm, as well as $25.1 million in BRIUMVI net sales in the U.S., which again exceeded our expectations." Mr. Weiss continued, "The adoption of BRIUMVI from both healthcare providers and centers continues to grow, which I believe positions us to close out the year on a positive note and I am excited for 2024 and for the future of BRIUMVI and TG."

Recent Highlights & Developments

General Business

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Total net quarterly revenue of $165.8 million, with a current cash position of $229.2 million

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Presented the first data from the ENHANCE Phase 3b trial evaluating patients with relapsing forms of multiple sclerosis (RMS) who switch from an IV anti-CD20 therapy to BRIUMVI, as well as additional exploratory data from the ULTIMATE I and II Phase 3 trials at the 2023 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting.

United States (U.S.) Commercialization of BRIUMVI (ublituximab-xiiy)

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Achieved $25.1 million in BRIUMVI net sales for the third quarter 2023; total net product revenue of approximately $48.9 million since launch.

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Secured payor coverage policies for approximately 95% of covered lives across the U.S.

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Over 900 BRIUMVI prescriptions in the third quarter of 2023, marking approximately 2,200 prescriptions since launch, from more than 500 healthcare providers at more than 250 centers.

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Received a permanent J-Code (J2329) for BRIUMVI from the U.S. Centers for Medicare & Medicaid Services (CMS), which became effective July 1, 2023.

European Commercialization of BRIUMVI
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Received European Commission (EC) approval of BRIUMVI, for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features, on June 1, 2023.

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Announced an agreement with Neuraxpharm for the ex-U.S. commercialization of BRIUMVI in RMS on August 1, 2023.

● Received approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS with active disease defined by clinical or imaging features in the United Kingdom (UK).

Financial Results for the Three and Nine Months Ended September 30, 2023

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Product Revenue, Net: Product revenue, net was approximately $25.1 million and $48.9 million for the three and nine months ended September 30, 2023, compared to $0.1 million and $2.6 million for the three and nine months ended September 30, 2022. Product revenue, net for the three and nine months ended September 30, 2023, consisted of net product sales of BRIUMVI in the U.S., which was commercially launched in late January 2023. Product revenue, net for the three and nine months ended September 30, 2022, consisted of net product sales of UKONIQ (umbralisib), which was withdrawn from the U.S. market in May of 2022.
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License revenue: License revenue was approximately $140.0 million and $140.1 million for the three and nine months ended September 30, 2023, compared to less than $0.1 million and $0.1 million for the three and nine months ended September 30, 2022. License revenue for the three and nine months ended September 30, 2023, is primarily related to the $140.0 million one-time payment received from Neuraxpharm in July 2023 upon execution of the agreement for the ex-U.S. commercialization of BRIUMVI in RMS.
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R&D Expenses: Total research and development (R&D) expense was $14.8 million and $58.7 million for the three and nine months ended September 30, 2023, compared to $20.8 million and $95.7 million for the three and nine months ended September 30, 2022. The decrease in R&D expense during the nine months ended September 30, 2023, was primarily attributable to reduced manufacturing expense and clinical trial related expenses, offset by an increase in license milestone expense of approximately $6.0 million during the nine months ended September 30, 2023. Prior to the approval of BRIUMVI, manufacturing costs pertaining to BRIUMVI were expensed to R&D expense in the period incurred, and following approval are reflected in inventory.
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SG&A Expenses: Total selling, general and administrative (SG&A) expense was $32.8 million and $91.6 million for the three and nine months ended September 30, 2023, compared to $14.3 million and $47.5 million for the three and nine months ended September 30, 2022. The increase was primarily due to non-cash compensation SG&A expenses incurred, and other costs, including personnel, associated with the commercialization of BRIUMVI during the three and nine months ended September 30, 2023.
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Net Income (Loss): Net income was $113.9 million and $27.1 million for the three and nine months ended September 30, 2023, compared to a net loss of $35.8 million and $145.3 million for the three and nine months ended September 30, 2022.

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Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $229.2 million as of September 30, 2023. We anticipate that our cash, cash equivalents and investment securities as of September 30, 2023, combined with the projected revenues from BRIUMVI, will be sufficient to fund our planned operations into cash flow positivity based on the current operating plan.

CONFERENCE CALL INFORMATION

The Company will host a conference call today, November 1, 2023, at 8:30 AM ET, to discuss the Company’s financial results from the third quarter, ended September 30, 2023.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.

On November 1, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported a preliminary update from the ongoing investigator-initiated Phase 2 clinical trial (NCT04906096) evaluating paxalisib as monotherapy treatment in patients with relapsed/refractory primary central nervous system lymphoma (r/r PCNSL) (Press release, Kazia Therapeutics, NOV 1, 2023, View Source [SID1234636641]).

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This is an open-label, Phase 2 clinical trial, led by Dr. Lakshmi Nayak MD, of the Dana-Farber Cancer Institute in Boston, MA. Eligible patients with r/r PCNSL will be administered paxalisib as monotherapy for up to 24 months, in an initial dosing regimen of 60mg daily, which is similar to the dosing regimen used for paxalisib clinical trials in other adult brain cancers. The objectives of the study are to assess the clinical efficacy and safety of paxalisib in up to twenty-five (25) patients with r/r PCNSL based on objective response rate (ORR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS). To date, fourteen (14) patients have been enrolled in the study.

Clinical activity has been preliminarily observed in enrolled patients, including partial responses and stable disease. Although early clinical activity was observed in some patients, several heavily pretreated r/r PCNSL patients experienced treatment-related adverse events consistent with those previously reported with paxalisib, that resulted in dose reductions and, in some cases, early termination from the study. As such, the protocol is being optimized by the investigator to initiate starting doses at 15mg twice a day or 30mg once a day with the goal of improving the durability of clinical benefit and overall tolerability.

"We are encouraged by the clinical activity preliminarily observed to date and agree with the lead investigator to reduce the dose with the goal of improving tolerability and durability of response," stated Dr. John Friend, CEO Kazia Therapeutics. "The investigator has enrolled over half the patients needed to complete this study, and we look forward to receiving additional clinical updates in the future."

Primary CNS Lymphoma

Primary central nervous system lymphoma (PCNSL) is a rare, poor prognosis subtype of extranodal, non-Hodgkin’s lymphoma (NHL), which accounts for 4% of primary brain tumours. Approximately 90% of PCNSL cases are diffuse large-B cell lymphoma (DLBCL) in origin, with T-cell lymphoma, Burkitt’s lymphoma and poorly characterized low-grade lymphoma representing a much smaller percentage of disease.

Despite an aggressive approach to the initial treatment involving high-dose methotrexate-based chemotherapy, whole-brain radiotherapy (WBRT) and autologous stem cell transplantation (ASCT), nearly 50% of patients recur after two years, with a third of patients becoming refractory early in the course of treatment.

Optimal therapy in the setting of either recurrence or treatment-refractoriness has not yet been established and most patients ultimately die of their disease, underscoring the fact that PCNSL remains a major unmet need in oncology today. The treatment of r/r PCNSL has largely been based on the experience gathered in numerous small retrospective studies and a limited number of prospective clinical trials. The clinical evidence from these approaches have demonstrated limited efficacy and durability.

Lymphoma outside the CNS has been a successful ‘use case’ for PI3K inhibitors, with four of the five FDA-approved therapies indicated for some form of the disease. There is a rationale for a brain-penetrant agent to examine CNS lymphoma, which is otherwise relatively treatment resistant to existing therapies.

On November 1, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that William Ho, CEO and co-founder, will participate in 1×1 meetings at the Truist Securities BioPharma Symposium being held Wednesday, November 8 and Thursday, November 9, 2023, in New York, NY (Press release, In8bio, NOV 1, 2023, View Source [SID1234636640]).

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The company expects multiple preclinical and clinical data updates through year-end 2023 including at the upcoming Society for Immunology of Cancer (SITC – abstract # 637, 418), Society for Neuro-Oncology (SNO), and American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meetings.