Adhera Therapeutics Signs Letter of Intent to Acquire CD71-Targeted Cancer Therapy Paclitaxel Gallium Transferrin

September 14, 2021

Adhera Therapeutics, Inc. (OTCQB: ATRX) ("Adhera" or the "Company"), a clinical stage biopharmaceutical company, today announces that the Company has entered a Heads of Terms (also known as a Letter of Intent (“LOI”)) agreement with Bio Innovation Group to acquire Paclitaxel Gallium Transferrin (“PGT”), a novel protein complex for targeted treatment of advanced cancers.

PGT is designed to deliver paclitaxel to cancer cells over-expressing Transferrin Receptor 1, also known as CD71 or TFR1. Paclitaxel is a commercially successful drug approved by the U.S. Food and Drug Administration (“FDA”) in two variations, solvent-based paclitaxel (sb-paclitaxel, brand name Taxol®) and protein-based paclitaxel (nab-paclitaxel, brand name ABRAXANE®). Sb-paclitaxel is approved for breast, ovarian, and lung cancer and Kaposi’s Sarcoma, while nab-paclitaxel is approved for breast, pancreatic, and non-small cell lung cancer. Each are often used off-label for a variety of hard-to-treat solid and liquid tumors.

Gallium nitrate (brand name GANITE®) is FDA-approved for hypercalcemia of malignancy, a common finding in patients with advanced stage cancer. With characteristics similar to iron, gallium has anti-cancer activity and has been shown to have synergistic activity in combination with other anti-cancer drugs.

Transferrin is a human blood protein that functions as an iron transport and natural ligand that binds to CD71-positive cells. Nab-paclitaxel uses albumin as its protein component. Pre-clinical research on PGT suggests that switching the protein component to transferrin could have potential advantages over albumin for developing a new targeted therapy, one that delivers a second, non-cross resistant agent, gallium.

“CD71 is regarded as an optimal target in oncology, yet it has proven elusive to new therapeutics because of its ubiquitous expression on the surface of generic cells, a challenge that we believe PGT could potentially overcome while hitting tumor cells with both paclitaxel and gallium,” commented Andrew Kucharchuk, Chief Executive Officer at Adhera Therapeutics. “Owing to the fact that CD71 is overly expressed on many different refractory tumors, we see an opportunity to develop a strategy that is focused on a specific cancer while simultaneously working to evolve a new drug for a tumor-agnostic secondary indication. PGT is a tremendous value add to our pipeline and we look forward to advancing the research on this promising new therapy.”

While best efforts are anticipated to advance the Heads of Terms agreement to an executed definitive agreement pursuant to which Adhera will acquire PGT, no assurances of such a development are expressed, implied, or guaranteed.

About Adhera Therapeutics

Adhera Therapeutics is a clinical stage biopharmaceutical company focused on identifying advanced drug candidates that may qualify for accelerated developmental pathways. The Company has licensed two drug candidates, MLR-1019 and MLR-1023, from the Melior Discovery family of companies. Adhera is developing MLR-1023 (tolimidone) as a new drug for Type I diabetes with a focus on C-peptide positive patients. Adhera also has exclusive rights to develop MLR-1023 for Non-Alcoholic Steatohepatitis (NASH) and pulmonary inflammation diseases and conditions. MLR-1023, a lyn kinase activator, has demonstrated exceptional clinical safety and tolerability in over 700 patients in Phase 2a and Phase 2b Type 2 diabetes studies. MLR-1019 (armesocarb) is a new class of drug for Parkinson’s Disease and is believed by the Company to represents the only drug to address both movement and non-movement symptoms of Parkinson’s Disease. Armesocarb is the active enantiomer in mesocarb, a drug marketed in Europe for 37 years for various psychiatric and central nervous system indications. In addition to advancing both drug candidates in Phase 2 clinical trials, the Company remains active in exploring other advanced drug development opportunities while maintaining its legacy assets, including CEQ508, an oral delivery of small interfering RNA (siRNA) against beta-catenin, to suppress polyps in the precancerous syndrome and orphan indication Familial Adenomatous Polyposis (FAP).

Forward Looking Statements

This press release contains forward-looking statements as defined by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including the anticipated benefits of the Company’s compounds, the initiation of Phase 2 trials, execution of license agreements, completion of a financing and the amount of proceeds, if any, from the contemplated financing and future collaborative opportunities. Forward-looking statements involve risks, uncertainties and assumptions that could cause Adhera Therapeutics' actual results and experiences to differ materially from anticipated results and expectations expressed in these forward looking statements. Adhera Therapeutics has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Adhera Therapeutics' need for, and the availability of, substantial capital in the future to fund its operations and research and development, the ability to agree upon the terms of the proposed financing with potential investors and existing noteholders and close on it, general risks in obtaining approval to initiate clinical trials, safety or efficacy issues arising during the trials, and the ultimate risks in reaching the commercialization stage. A more complete description of these risk factors is included in Adhera Therapeutics filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Adhera Therapeutics undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

Adhera Therapeutics, Inc.
Andrew Kucharchuk
Chief Executive Officer