On February 14, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported a shareholder update with a projected outlook for the current year (Press release, TC Biopharm, FEB 14, 2024, View Source [SID1234640101]).
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"The previous year was a time of significant operational achievement for TC BioPharm," said Bryan Kobel, Chief Executive Officer. "Despite strong headwinds throughout financial markets, we announced capital infusions of [approximately] $11.6 million while streamlining efficiencies, successfully dosing the final patient our ACHIEVE Study safety cohort and receiving FDA clearance of the Company’s investigational new drug (IND) application for a Phase 1B study in relapse/refractory Acute Myeloid Leukemia (AML). Additionally, we announced a new collaboration with Queen Mary University of London to expand TCB-008 into anti-fungal and anti-bacterial diseases, including non-dilutive funding to advance the project at lesser/lessened cost to the Company. Our team remains confident in TCB-008 as a therapeutic both as a monotherapy and in combination with other cell and immune system focused therapeutics, and looks forward to receiving interim data for the ACHIEVE trial in 2024. In March of 2023, we gave the investment community a roadmap of milestones we looked to complete in the subsequent 9 months of 2023, and it’s a great credit to the team that the Company was able to successfully achieve each of these milestones. We look forward/expect to continue this pattern of execution in 2024 and hitting our key milestones as laid out."
Recent Company Updates
● FDA clearance of investigational new drug (IND) application for a Phase 1B study in relapse/refractory Acute Myeloid Leukemia (AML)
● The Company streamlined efficiencies and reduced overhead on several fronts
● Formed a third-party manufacturing partnership in US with Excellos
● Entered into a collaboration agreement with Queen Mary University of London (QMUL) to expand the platform into non-oncology indications. The QMUL project received grant funding from The Impact Fund arm of QMUL, to research the therapeutic potential of gamma-delta T cells for the treatment of mucosal infections.
● Completed ACHIEVE Safety Cohort and received positive review from the Data Safety Monitoring Board (DSMB).
2024 Potential Milestones
● Interim data review for ACHIEVE trial studying TCB-008 in Acute Myeloid Leukemia
● Management is focused on leveraging existing strategic relationships in order to execute partnerships and or collaborations in combination with TCB-008.
● Platform expansion with Proof of Concept and preclinical work completed for its anti-fungal/anti-bacterial program
● Expected budget savings of approximately $11.6M after eliminating redundancies and asset prioritization efforts.
Filing of Preliminary Proxy Statement
On February 9, 2024 the Company filed a preliminary proxy statement with the Securities and Exchange Commission which included a proposal to obtain shareholder approval, in accordance with Nasdaq Marketplace Rule 5635(d), regarding the proposed sale, issuance, or potential issuance by the Company of Ordinary Shares or ADSs, in connection with certain non-public offerings, of the Ordinary Shares or ADSs (and/or securities convertible into or exercisable for Ordinary Shares or ADSs) equal to 20% or more outstanding immediately prior to the issuance of such securities at a price less than the lower of: (i) the closing price immediately preceding the signing of the binding agreement, or (ii) the average closing price of the ADSs for the five trading days immediately preceding the signing of the binding agreement for the transaction, subject to certain limitations. The Board of Directors of the Company has not yet determined the terms and conditions of any potential financing(s). This filing is not a registration statement and no shares have been issued or registered with the Securities and Exchange Commission (SEC). TC BioPharm has taken this step in light of converting from foreign filer status to a domestic filer status, and in order to comply with NASDAQ marketplace rules that are applicable to domestic filers.
Kobel continued, "In 2024, our goal is to make additional strides throughout our pipeline of differentiated gamma delta T cell therapies via a strategic and disciplined approach. Receiving clearance on our IND from the U.S. FDA of TCB-008 in Acute Myeloid Leukemia marks an important milestone in maximizing our lead therapeutics’ opportunity in the category of blood cancers that we believe it is ideally suited to address. Additionally, last week the Company filed a preliminary proxy statement relating to the Nasdaq stock exchange’s requirement of obtaining shareholder approval for the potential issuance of more than 20% of the shares outstanding. This relates to being positioned to effectively execute our business strategy over the coming 90 days, both in the M&A arena and access to capital, and is a function of timing as we shift from foreign filer status to domestic filer status for SEC reporting and NASDAQ compliance purposes."