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Brooklyn ImmunoTherapeutics Strengthens Investment in Licensed mRNA Technology Platform with $20M Financing

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Brooklyn ImmunoTherapeutics (NYSE American: BTX) has successfully completed a $20 million financing aimed at advancing its mRNA gene editing and cell therapies technology, licensed from Factor Biosciences and Novellus Therapeutics. The funds will facilitate the translation of this technology into clinical programs targeting orphan diseases, such as sickle cell anemia and familial amyloidosis. The licensed platform includes novel mRNA-based methods for gene editing and cellular reprogramming, enhancing therapeutic efficiency while minimizing off-target effects. Brooklyn's leading program is IRX-2, currently undergoing Phase 2A trials for head and neck cancer.

Positive
  • Completed $20 million financing to advance gene editing and cell therapy development.
  • Licensed innovative mRNA technology which may enhance treatment efficiency.
  • Focus on orphan diseases represents a strategic market opportunity.
  • IRX-2 shows promise with an overall survival benefit in head and neck cancer.
Negative
  • Uncertainties regarding the success of ongoing clinical trials.
  • Risks associated with regulatory approval from the U.S. FDA for IRX-2.

Brooklyn ImmunoTherapeutics LLC (NYSE American: BTX) ("Brooklyn"), a biopharmaceutical company currently focused on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer and blood disorders, today announced it has completed a $20M financing to progress the development of the mRNA gene editing and cell therapies technology recently licensed from Factor Biosciences and Novellus Therapeutics.

The Company intends to utilize the funds to commence translation of the gene editing, cellular therapy and nanolipid particle platform into its emerging clinical programs with a focus on orphan diseases, such as sickle cell anemia, familial amyloidosis and cell therapies for cancer.

“Our exclusive license of Factor Biosciences and Novellus Therapeutics platform technology represents a key component in our overall corporate strategy, and each progressive step toward the development of new therapeutics from this license brings us one step closer to realizing our vision of becoming a platform company with multiple products in a pipeline of next-generation immunotherapeutics and cellular therapies,” commented Howard J. Federoff, M.D., Ph.D., Brooklyn ImmunoTherapeutics’ Chief Executive Officer and President.

The exclusive license includes utilizing an extensively patented process to develop gene editing compounds using mRNA, which preclinical data suggest to be more efficient, non-immunogenic and non-mutagenic, to develop treatment for several solid tumor and liquid indications, sickle cell anemia, as well as a number of additional inherited disorders.

The licensed platform also includes two additional applications. The first is an mRNA cell reprogramming method, which is considered to be of the highest efficiency as well as a footprint-free technology that can be applied to both allogeneic and autologous cells, and is combined with an mRNA-based gene editing – along with a proprietary gene editing protein – to eliminate off-target effects. It also includes the proprietary ToRNAdo lipid delivery system that provides efficient non-viral vector-based delivery of mRNA ex vivo and in vivo to skin, brain, eye and lung tissue.

About Brooklyn ImmunoTherapeutics

Brooklyn is focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, both as a single agent and in combination with other anti-cancer therapies. The company is also exploring opportunities to advance oncology, blood disorder, and monogenic disease therapies using leading edge gene editing/cell therapy technology through the newly acquired license from Factor Bioscience and Novellus Therapeutics.

Brooklyn’s most advanced program is studying the safety and efficacy of IRX-2 in patients with head and neck cancer. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.

For more information about Brooklyn and its clinical programs, please visit www.BrooklynITx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are any statements that are not statements of historical fact and may be identified by terminology such as “expect,” “intend,” “plan,” “believe,” “anticipate,” “may,” “will,” “would,” “should,” “could,” “contemplate,” “estimate,” “predict,” “potential” or “continue,” or the negative of these terms or other similar words. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those stated or implied in any forward-looking statement as a result of various factors, including, but not limited to: (i) risks that the conditions to the closing of the proposed merger between Brooklyn and NTN will not be satisfied; (ii) uncertainties related to the impact of the COVID-19 pandemic on the business and financial condition of Brooklyn, including on the timing and cost of the BR-202 clinical trial; (iii) whether the BR-202 trial will be successful; (iv) whether IRX-2 will ever be approved for commercialization by the U.S. Food & Drug Administration, and (v) those other factors set forth in the proxy statement/prospectus/consent solicitation statement. You should not rely upon forward-looking statements as predictions of future events. Brooklyn cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication speak only as of the date on which they were made, and Brooklyn does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as may be required by applicable law or regulation.

FAQ

What recent financing did Brooklyn ImmunoTherapeutics announce?

Brooklyn ImmunoTherapeutics announced a successful completion of $20 million in financing.

What is the focus of Brooklyn ImmunoTherapeutics' new clinical programs?

The new clinical programs focus on orphan diseases including sickle cell anemia and familial amyloidosis.

What technology has Brooklyn ImmunoTherapeutics licensed?

Brooklyn has licensed mRNA gene editing and cell therapy technology from Factor Biosciences and Novellus Therapeutics.

What is the status of IRX-2 clinical trials?

The IRX-2 program is currently in Phase 2A trials for head and neck cancer, showing some overall survival benefit.

What risks does Brooklyn ImmunoTherapeutics face in its projects?

Brooklyn faces risks related to the success of clinical trials and regulatory approval from the U.S. FDA.

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