LadRx Corporation Issues Corporate Update for 3Q22

LadRx Corporation (OTCQB: LADX) (“LadRx” or the “Company”), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, today issued the below update to stockholders.

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Dear Stockholders,

Welcome to LadRx’s latest update for the quarter ending September 30, 2022. Please see our 10Q filed on November 10, 2022, for detailed financial reporting and analysis.

As a reminder, the Company has developed a chemotherapeutic delivery system called LADR (Linker-Activated Drug Release). LADR is a small organic molecule that can be attached to chemotherapeutic agents in order to target the delivery and release of the chemotherapeutic agent to solid cancers. The LADR-mediated targeting of chemotherapeutics to cancers could be reasonably expected to increase the amount of chemotherapeutic that can be safely dosed in a human (or in some cases allow for safe use of chemotherapeutics too powerful to be used without targeted delivery), and to reduce off-target side effects attributable to the chemotherapeutic agent.

The first-gen LADR-based chemotherapeutic that is most advanced is Aldoxorubicin. Aldoxorubicin is composed of the first-gen LADR molecule linked to the widely-used chemotherapeutic agent doxorubicin. Aldoxorubicin has proven the concept of LADR in that it can be dosed several times higher than doxorubicin, with fewer side effects. The Company out-licensed Aldoxorubicin to Immunity Bio, and Aldoxorubicin is currently in human clinical trials (see below).

The next-gen LADR-based drugs employ an improved linker. The Company’s current pre-clinical drug candidates are based on this next-gen LADR design, namely LADR7-10. LADR7 and 8 employ the highly potent chemotoxin Auristatin E, while LADR9 and 10 employ another highly potent chemotoxin called Maytansine.

LADR7

During Q3, we continued to move LADR7 towards IND in the most capital-efficient way possible. The IND-enabling activities for LADR7 at this stage include a full inventory of IND-enabling data generated thus far for LADR7, and developing the strategy for completing the IND-enabling work for LADR7, as well as dovetailing that strategy into future LADR products. As we have stated previously, we are pleased with the amount and quality of IND-enabling work that has been completed for LADRs7-10, and we feel that the IND-enabling work remaining for LADR7 is minimal. The next steps for LADR7 are to manufacture clinical-grade product, and to perform basic toxicology studies using the clinical-grade material (toxicology studies have already been performed with non-clinical-grade material). It is our current opinion that successful completion of these activities will position LADR7 for submission of an IND to the FDA. The steps of clinical-grade manufacture and final toxicology are expected to cost approximately $2M in direct costs, so we will not initiate this work until further funding is received (variations to this estimate can be expected as the project initiates).