On February 13, 2024 Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS), a commercial-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for inhaled KB707 for the treatment of patients with solid tumors with pulmonary metastases that are relapsed or refractory to standard of care therapy (Press release, Krystal Biotech, FEB 13, 2024, View Source [SID1234640048]).

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"The lung is often the predominant site of metastasis for many different cancers, most of which have limited or no standard of care immunotherapy treatment options" said Daniel Johnson, MD, Director of the Center for Innovative Cancer Therapies at the Ochsner MD Anderson Cancer Center Medical Center in New Orleans, LA. "The therapeutic benefits of cytokine therapy for the treatment of solid tumors have long been recognized, but difficult to harness due to toxicities when given systemically. Intra-tumoral injection of potent immunotherapies can avoid systemic toxicities, but many sites of disease, particularly the lung, are not accessible for direct injection. We are excited about the possibility of bringing cytokine therapy to this patient population via localized, sustained cytokine expression in the lung itself."

KB707 is a modified HSV-1 vector designed to deliver genes encoding both human interleukin-12 (IL-12) and interleukin-2 (IL-2) to the tumor microenvironment and promote systemic immune-mediated tumor clearance. In January 2024, the FDA cleared an amendment to the Company’s Investigational New Drug application to evaluate inhaled KB707 in a clinical trial to treat patients with locally advanced or metastatic solid tumors of the lung. The Company expects to dose the first patient in the open-label, multi-center, monotherapy, dose escalation and expansion Phase 1 clinical study (KYANITE-1) in the first half of 2024. Details of the study can be found at www.clinicaltrials.gov under NCT identifier: NCT06228326.

This is the second Fast Track Designation granted for KB707. In July 2023, the FDA granted intratumoral KB707 Fast Track Designation for the treatment of anti-programmed cell death protein-1 relapsed/refractory locally advanced or metastatic melanoma.

"The FDA’s decision to grant inhaled KB707 Fast Track Designation is a reflection of both the urgent unmet need that exists for patients with lung metastases and the robust preclinical data we have generated to date in stringent syngeneic mouse models of checkpoint inhibitor refractory metastatic disease," said Suma Krishnan, President, Research & Development, Krystal Biotech. "We look forward to the first patient being dosed with inhaled KB707 later this year."

About Fast Track Designation
Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and treat a serious or unmet medical need, enabling drugs to reach patients sooner. Clinical programs with Fast Track Designation may benefit from early and frequent communication with the FDA throughout the regulatory review process, and such clinical programs may be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

About KB707
IL-2 and IL-12 are secreted cytokines with complementary functions promoting cell-mediated immunity in humans. Both IL-2 and IL-12 have been shown to elicit anti-tumor immune responses in preclinical or clinical models and have been extensively studied for their potential in cancer immunotherapy. Despite promising signs of efficacy, it has proven difficult to effectively harness IL-2 and IL-12 for therapeutic benefit, as systemic administration is often poorly tolerated, and their inherently short half-lives necessitate high dose levels and extremely frequent dose intervals. KB707 is a modified HSV-1 vector designed to deliver genes encoding both human IL-12 and IL-2 directly to a patient’s tumor(s) and promote systemic immune-mediated tumor clearance. KB707 targets solid tumors that are accessible via intratumoral injection or inhalation.

On February 13, 2024 Roivant (Nasdaq: ROIV) reported its financial results for the third quarter ended December 31, 2023, and provided a business update (Press release, Roivant Sciences, FEB 13, 2024, View Source [SID1234640045]).

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Roivant completed the sale of Telavant to Roche for $7.1B with an additional $150M in cash payable upon the completion of a near-term milestone

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Batoclimab produced positive results in Graves’ disease with response rates meaningfully exceeding 50% in the initial cohort of an ongoing 24-week Phase 2 trial

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VTAMA (tapinarof) cream, 1% net product revenue was $20.7M for the quarter ended December 31, 2023, with over 300,000 prescriptions written by approximately 14,000 unique prescribers since launch

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New VTAMA positive long-term efficacy and safety data announced from analyses of the ADORING Phase 3 program in atopic dermatitis. Data from these analyses will be included in sNDA submission expected this quarter

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Brepocitinib topline data from the Phase 2 trial in patients with non-infectious uveitis (NIU) is expected this quarter

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Roivant reported its consolidated cash, cash equivalents and restricted cash of $6.7B at December 31, 2023, supporting cash runway into profitability

"This was another productive quarter across the company – we were pleased to announce the closing of the Telavant transaction with Roche in December. I am proud of our continued progress in clinical development, with another positive result generated by the Immunovant team in Graves’ disease. The positive initial data continues to support our view of the broad applicability of FcRn and the potentially meaningful clinical benefits associated with deeper IgG suppression," said Matt Gline, CEO of Roivant. "Looking ahead, we are excited about multiple upcoming clinical data readouts and other catalysts expected this year, as well as the prospect of expanding our clinical pipeline. 2024 will be a year of growth for Roivant."

Recent Developments

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Roivant: In December 2023, Roivant announced the completion of the sale of Telavant to Roche for an upfront payment of approximately $7.1 billion with an additional $150 million in cash payable upon the completion of a near-term milestone. Under the terms of the agreement, Roche gained the rights to develop, manufacture and commercialize RVT-3101 in the US and Japan for the treatment of inflammatory bowel disease and potentially other diseases. Prior to the closing of the transaction, Roivant owned 75% of the issued and outstanding shares of common stock and preferred stock of Telavant and Pfizer owned the remaining 25%, in each case on an as-converted basis. Roivant’s net cash proceeds from the transaction are approximately $5.2 billion. Approximately $110 million of the additional milestone payment will be payable to Roivant.

Roivant reported its consolidated cash, cash equivalents and restricted cash of $6.7 billion at December 31, 2023.

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Immunovant: In November 2023, Immunovant reported IMVT-1402, a second-generation antibody targeting the neonatal fragment crystallizable receptor (FcRn), continued to show potentially best-in-class profile in a Phase 1 clinical trial in healthy adults. Initial data from the 600 mg MAD cohort showed that four subcutaneously administered doses of 600 mg IMVT-1402 reduced total immunoglobulin G (IgG) levels by a mean of 74%, very similar to the 76% IgG reduction after four weekly injections of 680 mg batoclimab, but with no or minimal changes in serum albumin and LDL cholesterol, consistent with observations in placebo.

In December 2023, Immunovant reported in an open-label Phase 2 proof-of-concept clinical trial of batoclimab in Graves’ disease, response rates from an initial cohort of patients who were hyperthyroid despite treatment with an anti-thyroid medication for more than 12 weeks were meaningfully higher than 50 percent, after receiving once-weekly subcutaneous injections of 680 mg batoclimab for 12 weeks. This trial is ongoing.

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Dermavant: For the third quarter ended December 31, 2023, Roivant reported VTAMA net product revenue of $20.7M, representing a 28.5% gross-to-net yield for the quarter. As of February 2024, over 300,000 VTAMA prescriptions1 have been written by approximately 14,000 unique prescribers for psoriasis2, based on IQVIA data. VTAMA is covered for 137 million US commercial lives, including coverage by all three of the top pharmacy benefit managers.

In January 2024, Dermavant announced new positive efficacy and safety data from analyses of ADORING 3, an ongoing open-label, long-term extension Phase 3 trial being conducted to evaluate the safety and efficacy of VTAMA cream, 1% in patients with AD for up to 48 weeks of total treatment. The integrated analysis across the ADORING development program showed that efficacy continued to improve beyond the 8-week double blind treatment period in ADORING 1 and ADORING 2 across multiple endpoints including:

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vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline was observed in 73% (519/711) of patients included

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80.7% (574/711) of patients achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75)

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77.9% (218/280) of patients ≥12 years old with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score ≥4 achieved a ≥4-point reduction in PP-NRS

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92.3% (656/711) of patients achieved at least a 1-grade improvement in vIGA-AD score

The interim analysis of the ADORING 3 open-label, long-term extension Phase 3 trial demonstrated that 51.2% (373/728) of patients achieved complete disease clearance (vIGA-AD score of 0). No new safety signals were observed with up to 56 weeks of treatment. Data from these analyses will be included in sNDA submission expected this quarter.

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Hemavant: We have discontinued the development of RVT-2001 after an interim data analysis from the Phase 1/2 study.

Major Upcoming Milestones

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Immunovant expects initial results from period 1 of the Phase 2b clinical trial of batoclimab in CIDP in the second or third quarter of calendar year 2024, while top-line data from the Phase 3 clinical trials of batoclimab in MG and TED are on track and expected in the second half of calendar year 2024 and the first half of calendar year 2025, respectively. For IMVT-1402, Immunovant plans to initiate 4-5 potentially registrational programs by March 31, 2025 and plans to initiate trials in 10 indications by March 31, 2026 (inclusive of the 4-5 potentially registrational programs).

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Priovant expects to announce topline results from the Phase 2 POC study in non-infectious uveitis (NIU) in the first quarter of calendar year 2024 and topline results from the Phase 3 trial in dermatomyositis (DM) in calendar year 2025.

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Dermavant plans to submit its sNDA for VTAMA in atopic dermatitis to the FDA in the first quarter of calendar year 2024.

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Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the second half of calendar year 2024.

Third Quarter Ended December 31, 2023 Financial Summary
Cash Position
As of December 31, 2023, the Company had consolidated cash, cash equivalents and restricted cash of $6.7 billion.

Research and Development Expenses
Research and development expenses decreased by $1.8 million to $123.7 million for the three months ended December 31, 2023, compared to $125.5 million for the three months ended December 31, 2022. Changes in the components of research and development expenses included a decrease in program-specific costs of $10.0 million offset by increases in personnel-related expenses of $6.5 million and other expenses of $1.1 million.

Within program-specific costs, the decrease of $10.0 million was primarily driven by a decrease of $9.5 million related to other development and discovery programs due to the deconsolidation of Proteovant Sciences, Inc. ("Proteovant") in August 2023, along with the reprioritization of certain programs and drug discovery efforts, and decreases of $3.1 million each related to RVT-2001 and batoclimab. These decreases were partially offset by an increase in expense of $4.0 million related to RVT-3101, which was acquired in November 2022, and an increase of $3.5 million related to IMVT-1402. The rights to further develop and manufacture RVT-3101 were sold to Roche in December 2023.

The increase of $6.5 million in personnel-related expenses was primarily driven by a special one-time cash retention bonus award granted to employees during the three months ended December 31, 2023.

Non-GAAP R&D expenses were $115.2 million for the three months ended December 31, 2023, compared to $117.4 million for the three months ended December 31, 2022.

Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by $29.0 million to $197.3 million for the three months ended December 31, 2023, compared to $168.3 million for the three months ended December 31, 2022, primarily due to an increase in personnel-related expenses of $27.0 million as a result of a special one-time cash retention bonus award granted to employees.

Non-GAAP SG&A expenses were $148.4 million for the three months ended December 31, 2023, compared to $115.9 million for the three months ended December 31, 2022.

Gain on Sale of Telavant Net Assets
Gain on sale of Telavant net assets resulted from the sale of our entire equity interest in Telavant to Roche in December 2023. At closing, we received approximately $5.2 billion in cash for our pro rata portion of the consideration. Additionally, we derecognized the carrying amount of noncontrolling interest in Telavant of $87.5 million and transferred net liabilities of $26.5 million. This resulted in a gain of approximately $5.3 billion.

Net Income (Loss)
Net income was approximately $5.1 billion for the three months ended December 31, 2023, compared to a net loss of $384.9 million for the three months ended December 31, 2022. On a basic and diluted per common share basis, net income was $6.37 and $6.03, respectively, for the three months ended December 31, 2023. Basic and diluted net loss per common share was $0.49 for the three months ended December 31, 2022. Non-GAAP net loss was $174.9 million for the three months ended December 31, 2023, compared to $297.5 million for the three months ended December 31, 2022.

Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, February 13, 2024, to report its financial results for the third quarter ended December 31, 2023, and provide a corporate update.

To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.

On February 13, 2024 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, reported its financial results for the second quarter of fiscal 2024 ended December 31, 2023, and provided an update on recent business developments and outlook (Press release, Rezolute, FEB 13, 2024, View Source [SID1234640043]).

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"2024 is an exciting year of execution and milestones across our pipeline, with RZ358 continuing to demonstrate benefit to patients with hypoglycemia resulting from varying causes of hyperinsulinism, and in different indications," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We recently initiated sunRIZE, a global, pivotal, Phase 3 clinical study in patients with congenital hyperinsulinism, and we also continue to see favorable outcomes from our Expanded Access Program with RZ358, in patients with tumor-associated hyperinsulinism caused by insulinomas, for which we are evaluating a potential development program. Additionally, we completed enrollment in the Phase 2 study of RZ402 in patients with diabetic macular edema and look forward to reporting topline data from that program in the second quarter of 2024."

Clinical and Regulatory Highlights

RZ358 is a monoclonal antibody for the treatment of hyperinsulinism.

cHI
Rezolute initiated sunRIZE, a global, pivotal, Phase 3 clinical study in participants with cHI, in Europe and other geographies outside of the U.S.
Topline results expected mid-2025.
Innovation and Licensing Application Passport (ILAP) designation awarded to RZ358 for the treatment of cHI by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).
Designation was granted based on the recognition of substantial unmet medical need in this condition and the potential benefit to patients as evidenced by the Phase 2b RIZE study results in cHI, which safely demonstrated significant improvements in hypoglycemia.
Supplements analogous PRIME designation status already granted by the European Medicines Agency (EMA) in E.U.
taHI
RZ358 has been shown to counteract excessive insulin action downstream, at the insulin-receptor on target organs. The unique mechanism of action of RZ358 makes the therapy a potential universal treatment for hypoglycemia resulting from any cause of hyperinsulinism, including neuroendocrine tumors (insulinomas).
Given the unmet need in taHI and the potential therapeutic benefit of RZ358 as demonstrated in the individual case reports from the EAP, the Company met with FDA in January 2024 (January Meeting) and received a favorable opinion from the Agency on the feasibility of RZ358 being studied in a late-stage clinical trial as a new development program and second rare disease indication for RZ358.
In the January Meeting, FDA indicated that current dose caps on cHI studies would not be applicable to taHI studies. Therefore, considering the indication is primarily adult, current partial clinical holds pertaining to cHI studies would be largely irrelevant in taHI.
The Company remains engaged with FDA in the attempt to resolve ongoing partial clinical holds on clinical studies in the cHI indication.
RZ402 is a selective and potent oral plasma kallikrein inhibitor for the treatment of diabetic macular edema (DME).

Completed enrollment in Phase 2 U.S., multi-center, randomized, double-masked, placebo-controlled, parallel-arm study evaluating the safety, efficacy, and pharmacokinetics of RZ402 administered as an oral monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections.
Topline results expected in the second quarter of 2024.
Corporate Highlights

Expanded leadership team with appointment of Daron Evans, M.S., M.B.A, as Chief Financial Officer.
Mr. Evans has substantial experience leading public and private life science companies, with expertise in corporate finance, capital markets, and strategic transactions. He will help shepherd Rezolute through its next chapter in late-stage development.
Second Quarter Fiscal 2024 Financial Results

Cash, cash equivalents and investments in marketable debt securities totaled $96.0 million as of December 31, 2023, compared to $118.4 million as of June 30, 2023

Research and development expenses were $12.0 million for the second quarter of fiscal 2024, compared to $10.9 million for the same period in fiscal 2023, with the increase primarily attributable to increased expenditures in clinical trial activities and manufacturing costs

General and administrative expenses were $3.2 million for the second quarter of fiscal 2024, compared to $3.4 million for the same period in fiscal 2023, with the decrease primarily attributable to lower personnel-related expenses

Net loss was $13.9 million for the second quarter of fiscal 2024, compared to $13.6 million for the same period in fiscal 2023

On February 13, 2024 Quest Diagnostics (NYSE: DGX), the nation’s leading provider of diagnostic information services, reported the launch of MelaNodal Predict, a highly advanced predictive gene expression test to help personalize treatment decisions for patients with melanoma, the deadliest form of skin cancer and one of the most common cancers in the United States (Press release, Quest Diagnostics, FEB 13, 2024, View Source,-Personalizing-Melanoma-Risk-Prediction-to-Help-Patients-Forgo-Invasive-Surgery [SID1234640042]). Dermatologists and other providers nationwide may begin ordering the test today from Quest Diagnostics, as well as through Dermpath Diagnostics, Quest’s subspecialty pathology business.

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MelaNodal Predict is a lab-developed test validated by Quest Diagnostics and based on technology developed by SkylineDx, an oncology biotechnology company, alongside Mayo Clinic. The technology utilizes a combination analysis of patient age and tumor thickness with advanced gene expression profiling technology. MelaNodal Predict examines a patient’s original diagnostic tumor biopsy and applies an algorithm to help providers identify patients with a low or high risk of nodal metastasis (melanoma that has spread to the lymph nodes).

This insight may help providers identify patients that could, with less risk, avoid a potentially unnecessary, expensive and invasive surgery called a sentinel lymph node biopsy (SLNB). If the algorithm classifies a patient as low risk, they may be able to choose to forgo the procedure. More than 8 in 10 patients who have an SLNB are negative for nodal metastasis, based on post-surgical analysis.2

"Melanoma test services are an important component of our broad portfolio of advanced oncology tests," said Kristie Dolan, Senior Vice President and General Manager of Oncology at Quest Diagnostics. "By leveraging our scale, we can provide MelaNodal Predict to patients and treating physicians across the country to support clinical decision making. The MelaNodal Predict test’s results will help physicians identify their patient’s risk of metastasis to assist in individualizing surgical decisions and patient management plans."

By reducing SLNB interventions, providers who utilize the test may be able to more effectively use healthcare resources and manage patient risk. It is estimated that patients who receive an SLNB have a greater than 10% risk of surgery-related complications including bleeding, infection and limb swelling.3 The test also provides insights on a patient’s long-term outcome, as patients with a low-risk result have reported better survival rates. All studies of the algorithm utilized have reported minimal follow up after five years,4 and recent data from 6 US institutions shows that patients the algorithm classified as low risk have a survival rate of more than 90 percent.5

"This relationship between Quest and SkylineDx is a testament to the transformative impact that innovative collaborations can have in healthcare. SkylineDx’s expertise in molecular diagnostics, coupled with Dermpath Diagnostics’ leadership in dermatopathology, has elevated MelaNodal Predict to a new standard in personalized melanoma care," said Dharminder Chahal, CEO of SkylineDx. "Working with Quest Diagnostics will help us ensure we can continue to advance the field of molecular diagnostics and broaden access to our innovations. Together, we hope to make a meaningful impact on the lives of individuals impacted by this disease."

This collaboration aims to combine SkylineDx’s innovative technology with Quest’s expertise and national scale in the United States, which includes broad electronic health record connectivity and health plan relationships and over 400 Quest, Dermpath, AmeriPath, and PhenoPath pathologists. A leader in advanced oncology diagnostics, Quest specializes in testing for inherited genetic disorders and tumor sequencing for colorectal and other cancers. The pathology businesses of Quest Diagnostics deliver subspecialty expertise for health systems and other providers in the United States and overseas.

About SkylineDx
SkylineDx is a biotechnology company focused on research and development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam, the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego, California, USA. To learn more about SkylineDx, please visit www.skylinedx.com.

On February 13, 2024 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, reported results for the three and six months ended December 31, 2023, and highlighted recent corporate events (Press release, MEI Pharma, FEB 13, 2024, View Source [SID1234640037]).

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"In the ongoing clinical studies for both voruciclib, our oral CDK9 inhibitor, and ME-344, our inhibitor of mitochondrial oxidative phosphorylation, we are gratified by strong investigator support and enrollment that remains on-track, and we look forward to preliminary study read-outs in the near future," said David M. Urso, president and chief executive officer of MEI Pharma. "We are planning to report initial safety and efficacy data during the first half of this calendar year for both voruciclib and ME-344, which are intended to provide preliminary clinical validation and support the further development of our programs."

Select Second Quarter Fiscal Year 2024 and Recent Highlights

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In January 2024, MEI presented a Trials in Progress poster of the ongoing Phase 1b study of ME-344, our mitochondrial oxidative phosphorylation (OXPHOS) inhibitor, evaluating the combination with bevacizumab (Avastin) in refractory metastatic colorectal cancer patients at the 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium.

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In December 2023, MEI presented a poster reporting complete clinical data from the monotherapy dose escalation stage of the Phase 1 study evaluating voruciclib, our selective oral cyclin-dependent kinase 9 ("CDK9") inhibitor, in patients with relapsed or refractory (r/r) acute myeloid leukemia ("AML") or B-cell malignancies at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Also reported was the early experience of voruciclib in combination with venetoclax (Venclexta), a B-cell lymphoma 2 ("BCL2") inhibitor, in the ongoing stage of the study evaluating the combination.

Expected Drug Candidate Pipeline Developments

Voruciclib – Oral CDK9 inhibitor in Phase 1 Study

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We expect to report clinical data from the dose escalation portion of the ongoing Phase 1 clinical trial evaluating voruciclib plus venetoclax in patients with r/r AML in the first calendar quarter of 2024.

This updated voruciclib program guidance reflects continuation of the dose escalation portion of the study evaluating the combination with venetoclax in patients with r/r AML. Because we are seeing clinical activity, including complete responses, and no dose limiting toxicities, we decided in agreement with the investigators to evaluate additional dose levels before selecting a dose for the expansion cohort. We have completed enrollment of the group evaluating a 300 mg dose of voruciclib in combination with venetoclax.

ME-344 – Mitochondrial inhibitor in Phase 1b Study

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We have completed enrollment in Cohort 1 of the Phase 1b clinical study evaluating ME-344 plus bevacizumab in patients with relapsed colorectal cancer. We expect to report data from Cohort 1 in the first half of calendar-year 2024.

Three and Six Month Fiscal Year 2024 Financial Results

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As of December 31, 2023, MEI had $59.5 million in cash, cash equivalents, and short-term investments with no outstanding debt.

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For the six months ended December 31, 2023, cash used in operations was $29.5 million, compared to $29.1 million during the six months ended December 31, 2022, primarily due to the timing of payments on operating liabilities as compared to the prior period combined with lower clinical spend due to the wind down of the zandelisib program resulting from the discontinuation of development activities announced in December 2022.

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Research and development expenses decreased by $11.4 million to $3.9 million for the quarter ended December 31, 2023, compared to $15.3 million for the quarter ended December 31, 2022. The decrease was primarily related to a reduction in zandelisib program costs, as well as reduced personnel and related costs from our reductions in headcount. These decreases were slightly offset by increases related to clinical and manufacturing costs associated with the Phase 1b study for ME-344.

img183464774_0.jpg

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General and administrative expenses decreased by $0.5 million to $8.0 million for the quarter ended December 31, 2023, compared to $8.5 million for the quarter ended December 31, 2022. The net decrease was primarily related to reduced personnel and related costs from our reductions in headcount, offset by higher external legal expenses.

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MEI recognized no revenue for the quarter ended December 31, 2023, compared to $32.7 million for the quarter ended December 31, 2022. The decrease in revenue was due to all remaining noncash deferred revenue associated with the Kyowa Kirin Commercialization Agreement having been recognized in the first quarter of fiscal year 2024 due to the termination of that agreement in July 2023.

The Company believes its cash balance is sufficient to fund operations for at least the next 12 months, and through the reporting of clinical data readouts from the ongoing and planned voruciclib Phase 1 and ME-344 Phase 1b clinical programs.