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MEI Pharma Reports First Quarter Fiscal Year 2024 Results and Operational Highlights

On November 9, 2023 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 quarter ended September 30, 2023 and highlighted recent corporate events (Press release, MEI Pharma, NOV 9, 2023, View Source [SID1234637448]).

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"Our ongoing clinical studies evaluating the combination of voruciclib, our CDK9 inhibitor, with Venclexta in relapsed/refractory AML patients and ME-344, our mitochondrial inhibitor, combined with Avastin in metastatic colorectal cancer patients, continue to have strong investigator support and cohort enrollment remains on track in each program," said David M. Urso, president and chief executive officer of MEI Pharma. "We expect to report data from the dose escalation portion of the Phase 1 clinical trial evaluating voruciclib in combination with venetoclax in early calendar 2024, and data from the first cohort of patients in Phase 1b clinical trial evaluating ME-344 in the first half of 2024."

First Quarter Fiscal Year 2024 and Recent Highlights

In August 2023, MEI announced the dosing of the first patient in a Phase 1b study evaluating ME-344 in combination with bevacizumab (AVASTIN) in patients with previously treated metastatic colorectal cancer. ME-344 is a novel mitochondrial inhibitor targeting energy production through the OXPHOS pathway, which is important for supporting tumor cell survival and proliferation for many forms of cancer, including colorectal cancer. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, and other antiangiogenics, inhibit energy production through glycolysis and, thereby, increase tumor reliance on mitochondrial energy production, providing an opportunity to evaluate a combination with ME-344 to inhibit energy production in tumor cells and induce an antitumor effect. The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.
In November 2023, MEI announced that an abstract highlighting clinical data from the monotherapy dose escalation stage of the ongoing Phase 1 study evaluating voruciclib, a selective oral cyclin-dependent kinase 9 (CDK9) inhibitor, alone and in combination with venetoclax (Venclexta), a B-cell lymphoma 2 ("BCL2") inhibitor, in patients with acute myeloid leukemia (AML) or B-cell malignancies, will be presented during a poster session at the upcoming 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held December 9 – 12, 2023.
Expected Drug Candidate Pipeline Developments

Voruciclib – Oral CDK9 inhibitor in Phase 1 Study

Report clinical data from the dose escalation portion of the ongoing Phase 1 clinical trial evaluating voruciclib plus Venclexta (venetoclax) in patients with AML early in calendar 2024.
ME-344 – Mitochondrial inhibitor in Phase 1b Study

Report clinical data from Cohort 1 of the Phase 1b clinical trial evaluating ME-344 plus Avastin (bevacizumab) in patients with relapsed colorectal cancer in the first half of calendar-year 2024.
First Quarter Fiscal Year 2024 Financial Results

As of September 30, 2023, MEI had $82.2 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended September 30, 2023, cash used in operations was $18.5 million, compared to $14.8 million during the quarter ended September 30, 2022. The increase in cash used in operations was primarily due to changes in working capital associated with the wind down of zandelisib activities with Kyowa Kirin and professional services primarily related to advisory and legal fees associated with various stockholder-related activities, including stockholder-initiated consent solicitations.

Research and development expenses were $3.5 million for the quarter ended September 30, 2023, compared to $19.5 million for the quarter ended September 30, 2022. The decrease was primarily related to a reduction in zandelisib costs as we continued the wind down of development activities announced in December 2022, as well as reduced personnel and related costs from our fiscal year 2023 reduction in headcount.
General and administrative expenses decreased by $1.0 million to $6.5 million for the quarter ended September 30, 2023, compared to $7.5 million for the quarter ended September 30, 2022. The net decrease was primarily related to reduced personnel and related costs from our fiscal year 2023 reduction in headcount, partially offset by higher external professional services and legal expenses.

MEI recognized revenue of $65.3 million for the quarter ended September 30, 2023, compared to $8.7 million for the quarter ended September 30, 2022. The increase in revenue is due to the recognition of deferred revenue associated primarily with the termination of the Kyowa Kirin Commercialization Agreement in July 2023. As of September 30, 2023, all deferred revenue associated with that agreement has been recognized.
Net income was $56.4 million, or $8.46 per share, for the quarter ended September 30, 2023, compared to net loss of $16.6 million, or $2.49 per share for the quarter ended September 30, 2022. The Company had 6,662,857 shares of common stock outstanding as of September 30, 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 and ME-344 Phase 1 and Phase 1b clinical programs, respectively.

Trishula Therapeutics Initiates Phase 2 Trial of TTX-030, an Anti-CD39 Antibody, in First Line Metastatic Pancreatic Cancer Patients

On November 9, 2023 Trishula Therapeutics, Inc., a clinical stage, privately held biotechnology company, reported the initiation of a randomized Phase 2 trial to evaluate the efficacy and safety of TTX-030, a potential first-in-class, anti-CD39 antibody (Press release, Trishula Therapeutics, NOV 9, 2023, View Source [SID1234637447]). The trial will evaluate TTX-030 in combination with chemotherapy, with or without budigalimab (an investigational anti-PD-1 antibody), compared to chemotherapy alone, as first-line treatment for metastatic pancreatic ductal adenocarcinoma patients.

"There is significant unmet need for new treatment options for pancreatic cancer," said Anil Singhal, Chief Executive Officer of Trishula Therapeutics. "We look forward to building on the promising Phase 1 results to potentially advance the treatment landscape with TTX-030, which may bring benefit to patients with advanced pancreatic cancer."

The study is designed to enroll approximately 180 patients globally. Patients will be randomized equally into three study arms, receiving TTX-030 and chemotherapy (gemcitabine and nab-paclitaxel); TTX-030 and chemotherapy plus budigalimab; or chemotherapy alone. The primary endpoint of the trial is progression free survival (PFS) in a biomarker-enriched population. Secondary endpoints include PFS in the overall population, safety, objective response rate, duration of response and overall survival. Further information on the study can be found at (clinicaltrials.gov link).

Trishula will continue to develop TTX-030 in collaboration with AbbVie Inc. Per the terms of the collaboration agreement, at the conclusion of this Phase 2 study, AbbVie will have an exclusive option to license TTX-030 for further development.

About TTX-030TTX-030 is a potential first-in-class, anti-CD39 antibody designed to inhibit the activity of CD39, an enzyme that converts adenosine triphosphate (ATP) to adenosine monophosphate (AMP), the initial step in the generation of adenosine in the tumor microenvironment. TTX-030 prevents the formation of immune-suppressive extracellular adenosine and maintains high levels of immune-activating extracellular ATP, stimulating dendritic and myeloid-derived cells promoting both innate and adaptive anti-tumor immunity.

Vyriad Announces Oral Presentation at the 65th American Society of Hematology Annual Meeting

On November 9, 2023 Vyriad, Inc., a clinical-stage biotechnology company developing the next generation of targeted genetic therapies, reported that its abstract, In Vivo Generation of Functional CD19 CAR-T Cells Using a Serum-Stable CD3-Targeted Lentiviral Vector, has been selected for an oral presentation at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 9-12, 2023, in San Diego, California (Press release, Vyriad, NOV 9, 2023, View Source [SID1234637445]). Vyriad’s presentation will discuss progress in developing its highly targeted, efficient, serum-stable and durable lentiviral vector technology to deliver genetic payloads directly and specifically to CD3+ T cells.

Presentation Title: In Vivo Generation of Functional CD19 CAR-T Cells Using a Serum-Stable CD3-Targeted Lentiviral Vector

Session Name: Cellular Immunotherapies: Basic and Translational: Exploring Novel Platforms for Next-Gen CAR-based Therapies

Presentation Date/Time: Monday, December 11, at 11:30 a.m. PT

Presenting Speaker: Stephen J. Russell, M.D., Ph.D., Chief Executive Officer

Full abstracts are available for online viewing via the ASH (Free ASH Whitepaper) Annual Meeting website at www.Hematology.org.

MVR-T3011 IV, Global First Intravenous Oncolytic Product, Successfully Concludes Phase I Clinical Study in the U.S. with Outstanding Safety Results

On November 9, 2023 ImmVira reported the successful completion of Phase I clinical study conducted on late-stage patients with various tumor types for our intravenous oncolytic product, MVR-T3011 IV, in the United States (Press release, Immvira, NOV 9, 2023, View Source [SID1234637444]). This milestone was marked by the product’s exceptional safety results and preliminary efficacy for certain indications. Concurrently, a series of comprehensive pharmacokinetics/pharmacodynamics (PK/PD) and immune responses research were also conducted, generating valuable firsthand data to guide the forthcoming Phase II clinical study.

As of October 31, 2023, 17 patients (17/18, 94.4%) experienced Treatment-Emergent Adverse Events (TEAEs), with 16 patients (16/18, 88.89%) reporting drug-related Treatment-Related Adverse Events (TRAEs). Notably, all of these adverse events were of grade 1 or 2 severity, and no TRAEs of grade 3 or higher were observed. TEAEs with an incidence of over 20% included abdominal pain (4/18, 22.2%), urinary tract infection (5/18, 27.28%), nausea (6/18, 33.3%), hypokalaemia (4/18, 22.2%) and hypotension (6/18, 33.3%). 7 patients (7/18, 38.89%) experienced Serious Adverse Events (SAEs), none of which were drug-related.

Overall, MVR-T3011 IV showed great safety profile at Phase I clinical study. Currently, there are 12 evaluable patients. According to RECIST 1.1, patients with endometrial, appendiceal, and gallbladder cancer demonstrated a significant reduction in tumor burden. The maximum reduction exceeded 15% compared to the baseline.

Simultaneously, Company is conducting a series of clinical exploratory studies in China for multiple tumor types. By combining PK/PD data from Phase I clinical study in both the U.S. and China, our goal is to devise a development strategy for a registrational Phase II clinical study targeting real unmet clinical needs.

Chairwoman and CEO Dr. Grace Guoying Zhou said that, "The development of intravenously administered oncolytic virus products has long been a challenging bottleneck. Oncolytic viruses must overcome numerous hurdles, such as neutralization by antibodies or the risk of cytokine storms, in order to effectively reach tumor sites with a sufficient number of viruses to achieve anti-tumor effects. With the successful Phase I clinical study results of MVR-T3011 IV, global first clinical-stage intravenous oHSV product, our company is now fully confident and committed to expediting clinical explorations in colorectal cancer, non-small cell lung cancer, and other indications, including combination treatments with immune checkpoint inhibitor or chemotherapy. Our goal is to bring the benefits of intravenous oncolytic virotherapy to cancer patients as swiftly as possible."

About MVR-T3011

MVR-T3011, ImmVira’s proprietary 3-in-1 oHSV, is a novel genetically engineered oHSV, which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells. Its incorporation of two latest and well-validated exogenous genes, PD-1 antibody and IL-12, further enhances immune responses in the tumor microenvironment.

Aeterna Zentaris Reports Third Quarter 2023 Financial Results

On November 9, 2023 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported its financial and operating results for the quarter ended September 30, 2023 (Press release, AEterna Zentaris, NOV 9, 2023, View Source;b=2533&ID=128359&m=rl&g=1592 [SID1234637443]).

"We are pleased with the progress made in the last quarter with respect to the commercialization of Ghryvelin (macimorelin and previously sold in the United States as Macrilen) in the European Economic Area (EEA). Following regional pricing approvals, Pharmanovia, our commercialization partner in the EEA, has launched Ghryvelin in the UK, Germany, Scandinavia and other countries in the EEA, and is expecting to launch Ghryvelin in additional countries in the EEA during the remainder of 2023 and into the first half of 2024. In South Korea, Macrilen granules received MFDS approval in September so that, together with our partner NK Meditech, we are now preparing to launch Macrilen in the South Korean market," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "We are also encouraged with the progress we are making with our ongoing research program involving the use of the AIM biologics platform to treat neuromyelitis optica spectrum disorder (NMOSD) where we achieved ex-vivo proof of mode of action by regulatory T-Cell activation in human peripheral blood mononuclear cells of healthy donors and NMOSD patients. Our efforts to advance our programs are supported by our strong cash position which we believe enables us to meet our currently projected cash needs into 2025."

Summary of Third Quarter 2023 Financial Results

All amounts are in U.S. Dollars

Cash and cash equivalents

The Company had $38.8 million in cash and cash equivalents at September 30, 2023.

Results of operations for the three-month period ended September 30, 2023

For the three-month period ended September 30, 2023, we reported a consolidated net loss of $4.1 million, or $0.85 loss per common share (basic and diluted), as compared with a consolidated net loss of $3.4 million, or $0.70 loss per common share (basic) for the three-month period ended September 30, 2022.

Revenues

Our total revenue for the three-month period ended September 30, 2023, was $0.0 million as compared with $1.9 million for the same period in 2022, representing a decrease of $1.9 million. The decrease was due to required transition time in onboarding our new partner, Pharmanovia, as it pertained to marketing Ghryvelin in the European Economic Area and United Kingdom, as well as the termination of the Company’s amended agreement with Novo Nordisk Healthcare in May 2023.
Operating Expenses

Our total operating expenses for the three-month period ended September 30, 2023 were $4.6 million as compared with $5.6 million for the same period in 2022, representing a decrease of $1.0 million. This decrease arose from a $0.5 million decrease in research and development expenses, related to a decrease of $0.4 million in our AEZS-130 Macimorelin ALS project and a net decrease of $0.1 million for all other projects, as well as a $0.5 million decrease in the selling, general & administrative expenses.
Net Finance Income

For the three-month period ended September 30, 2023, our net finance income was $0.4 million as compared to $0.3 million for the three-month period ended September 30, 2022, representing an increase of $0.1 million. This was primarily due to an increase in interest earned on bank deposits of $0.4 million offset by a $0.3 million decrease in our gain (loss) due to changes in foreign currency.
Results of operations for the nine-month period ended September 30, 2023

For the nine-month period ended September 30, 2023, we reported a consolidated net loss of $10.9 million, or $2.25 loss per common share (basic and diluted), as compared with a consolidated net loss of $10.3 million, or $2.12 loss per common share (basic) for the nine-month period ended September 30, 2022.

Revenues

Our total revenue for the nine-month period ended September 30, 2023, was $4.4 million as compared to $3.2 million for the same period in 2022, representing an increase of $1.2 million. The increase was due to an increase in license fee revenue recognized of $0.7 million and development services revenue of $0.7 million relating to the Company’s amended agreement with Novo Nordisk Healthcare, offset by a combined $0.2 million decrease in all other revenues.
Operating Expenses

Our total operating expenses for the nine-month period ended September 30, 2023 were $16.0 million as compared with $14.4 million for the same period in 2022, representing an increase of $1.6 million. This increase was due to a $1.6 million increase in research and development expenses, primarily related to a $0.9 million increase in the DETECT trial, a $0.5 million increase in our AEZS-130 Macimorelin ALS project and a $0.4 million increase in our AIM-Biologicals – NMOSD project offset by a decrease of approximately $0.4 million for all other projects.
Net Finance Income

For the nine-month period ended September 30, 2023, our net finance income was $0.7 million as compared to $1.0 million for the nine-month period ended September 30, 2022, representing a decrease of $0.3 million. This decrease was the result of a $1.0 million decrease in gains due to changes in foreign currency rates offset by a $0.7 million increase in interest income.
Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Company’s Management’s Discussion and Analysis of Financial Condition and Results of Operations for the third quarter 2023, as well as the Company’s unaudited consolidated interim financial statements as of September 30, 2023, will be available on the Company’s website (www.zentaris.com) in the Investors section or at the Company’s profile at www.sedarplus.com and www.sec.gov.