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.

On November 1, 2023 Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, reported that it will present data for KIMMTRAK (tebentafusp-tebn) in metastatic uveal melanoma and cutaneous melanoma at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting (1st – 5th November) and the Society for Melanoma Research (SMR) Congress (6th – 9th November) (Press release, Immunocore, NOV 1, 2023, View Source [SID1234636639]).

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Across the two scientific conferences, the company will present seven posters:

Presentation and poster details

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)

Title: Molecular features associated with long survival on tebentafusp in previously untreated metastatic uveal melanoma in a phase 3 trial (abstract #30)
Presenting author: Marlana Orloff
Session: Poster Hall, Saturday November 4, 2023

Title: Novel regulators of ImmTAC-mediated killing of melanoma cancer cells revealed by genome-wide CRISPR-Cas9 screens (abstract #1108)
Presenting author: Aleksandra Raczka
Session: Poster Hall, Saturday November 4, 2023

Society for Melanoma Research

Title: Propensity score analysis of the effect of corticosteroids on survival from tebentafusp in metastatic uveal melanoma (mUM) (poster #P-096)
Presenting author: Alexandra Ikeguchi
Session: Poster display, Monday November 6, 2023 – Wednesday November 8, 2023

Title: Tumor microenvironment (TME) features and serum cytokines in patients with metastatic uveal and cutaneous melanoma treated with tebentafusp (poster #P-225)
Presenting author: Omid Hamid
Session: Poster display, Monday November 6, 2023 – Wednesday November 8, 2023

Title: A Phase 2/3 trial in progress on tebentafusp as monotherapy and in combination with pembrolizumab in HLA-A*02:01+ patients with previously treated advanced non-uveal melanoma (TEBE-AM) (poster #P-047)
Presenting author: Diwakar Davar
Session: Poster display, Monday November 6, 2023 – Wednesday November 8, 2023

Title: Evidence of tumor response in orbital lesions treated with tebentafusp in metastatic uveal melanoma patients (poster #P-089)
Presenting author: Marcus Butler
Session: Poster display, Monday November 6, 2023 – Wednesday November 8, 2023

Title: Early ctDNA reduction is associated with better overall survival in the Ph 3 trial of tebentafusp in previously untreated metastatic uveal melanoma (poster #P-163)
Presenting author: Ryan Sullivan
Session: Poster display, Monday November 6, 2023 – Wednesday November 8, 2023

On November 1, 2023 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company") reported the expansion of its AI-powered technology stack with the launch of ShieldTx, a patent-pending antibody masking technology designed to enable specific, highly targeted antibody delivery to diseased tissue without harming healthy tissue (Press release, iBioPharma, NOV 1, 2023, View Source [SID1234636638]). By adding ShieldTx to its Drug Discovery Platform, iBio uniquely integrates antibody engineering and masking in one accelerated process to potentially overcome the challenges of complex targets, safety, and developability in next-generation antibody discovery and development.

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The Company used ShieldTx to develop masks for its MUC16-targeted bispecific antibody ("Ab") candidates, which were previously developed using iBio’s patented Epitope Steering and EngageTx AI Platforms. MUC16 is a well-known cancer target often overexpressed in several types of solid tumors, including ovarian, lung, and pancreatic cancers.

One of the main challenges of therapeutic antibody discovery is drug targets are often expressed on both healthy and diseased tissue, resulting in off-tissue side effects. Scientists are increasingly turning to antibody masking to reduce or eliminate these side effects. Masks deactivate Abs until they encounter a specific enzyme only present in the target diseased tissue. When masked Abs engage with this specific enzyme, the mask is removed, and the antibody is activated. This approach reduces or eliminates off-tissue side effects, enhances the therapeutic safety range, and reduces the risk of an unwanted immune response of bispecific Abs1. In an in vitro laboratory setting, iBio’s specially designed MUC16 bispecific Abs were deactivated and then reactivated, demonstrating successful application of the ShieldTx technology.

Traditional masking techniques are complex procedures and require the sequential optimization of antibody and mask. This increases development time and risk by adding more steps to a typically linear development and optimization process.

"Our technology aims to advance antibody masking by fine-tuning both the mask and antibody in tandem using our StableHu antibody optimizer and its mammalian display technology," said Matt Greving, Ph.D., VP & Head of Machine Learning & Platform Technologies at iBio. "This potentially reduces repetitive steps and may significantly boost the probability of success in creating masked antibodies. ShieldTx can be applied to cancer therapeutics, and potentially to autoimmune and inflammatory diseases. iBio intends to use ShieldTx to further optimize its current antibody candidates, particularly the bispecific TROP-2 x CD3 molecules developed using our proprietary T-cell engager antibody panel, EngageTx."

"With 40% of approved antibodies working against just 10 targets2, there is significant potential for therapeutic development against additional new targets; but unfortunately, these targets are often difficult and complex, and require new technologies to optimize antibody discovery and development," added iBio’s Chief Executive Officer and Chief Scientific Officer, Martin Brenner, DVM, Ph.D. "We are rapidly building an integrated end-to-end platform incorporating the most innovative technologies in machine learning, computational biology, and synthetic biology to enable iBio and our partners to craft the next generation of antibody-based therapeutics against difficult targets and modes of action. ShieldTx is the latest example, following the launch of EngageTx earlier this year."