CytRx Comments on Proposed Combination of ImmunityBio and NantKwest

CytRx out-licensed global development, manufacturing and commercialization rights for aldoxorubicin to ImmunityBio in 2017. The Company has an agreement with ImmunityBio that can yield up to $343 million in potential milestone payments and single and double-digit royalties on sales of aldoxorubicin.

In their announcement, ImmunityBio and NantKwest highlighted that the combined entity will have a broad clinical-stage pipeline – including 13 assets in clinical trials and 11 in Phase 2 to 3 programs – as well as a robust early-stage pipeline to address other difficult to treat cancers. The companies also noted that the combination of NantKwest’s Natural Killer cell platform and ImmunityBio’s immunotherapy platforms – including albumin-based tumor microenvironment immune modulators (aldoxorubicin) – have already resulted in complete responses in aggressive and late-stage metastatic cancers. To date, complete responses have been noted in patients with second-line or greater metastatic pancreatic cancer, triple-negative breast cancer, head and neck cancer, and Merkel Cell Carcinoma.

Notably, ImmunityBio and NantKwest recently announced the addition of a third cohort to an ongoing Phase 2 study of a novel combination immunotherapy – which includes aldoxorubicin – for locally advanced or metastatic pancreatic cancer (QUILT-88). As previously outlined in CytRx’s October 7, 2020 announcement regarding the successful treatment delivered to former Nevada Senator Harry Reid for his stage IV pancreatic cancer, the randomized, open-label study is evaluating the safety and efficacy of a combination immunotherapy that includes aldoxorubicin, ImmunityBio’s IL-15 superagonist Anktiva (N-803), NantKwest’s PD-L1 t-haNK and standard of care. The study results will be compared to standard of care chemotherapy for first- and second-line treatment. However, the third-line cohort is a single arm with no comparator and each cohort will be evaluated independently to provide a more precise comparative.

Dr. Patrick Soon-Shiong, founder and Chief Executive Officer of ImmunityBio, issued the following statement yesterday regarding the proposed merger:

“We are developing next-generation immunotherapies to defeat cancer and infectious disease. By combining ImmunityBio’s immunotherapy platform, which includes the Anktiva IL-15 superagonist, with NantKwest’s natural killer cell platform, the merged entity will have a powerful and broad product portfolio that can activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term immunological memory. What distinguishes the merged entity is the late stage immunotherapy product pipeline that is designed to eliminate the need for high-dose chemotherapy, improve the outcomes of current CAR T cell therapies, and extend beyond checkpoint inhibitors. With 13 clinical trials across multiple tumor types at Phase I to III and with the combined talent in research, clinical development and manufacturing, the merged entity is poised to be a leader in the immunotherapy space.”

Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, commented:

“This proposed combination is an exciting development that can help ImmunityBio put even greater energy and resources behind innovative clinical programs, including its Phase 2 study of a novel pancreatic cancer treatment that includes aldoxorubicin. We are encouraged to see that ImmunityBio is presenting aldoxorubicin as one of the cornerstones of its clinical-stage platforms. If approved, this merger can be transformative for providers and patients fighting cancer and rare diseases.”

For more information about the transaction, stakeholders can visit www.immunitybio.com. ImmunityBio’s website also notes that its albumin associated anthracycline is designed to release doxorubicin directly into tumor sites with lower side effects (reduced cardiotoxicity and loss of hair).

About CytRx Corporation

CytRx Corporation (OTCQB: CYTR) is a biopharmaceutical company with expertise in discovering and developing new therapeutics principally to treat patients with cancer and neurodegenerative diseases. CytRx’s most advanced drug conjugate, aldoxorubicin, is an improved version of the widely used anti-cancer drug doxorubicin and has been outlicensed to ImmunityBio, Inc. In addition, CytRx’s other drug candidate, arimoclomol, was sold to Orphazyme (Nasdaq: ORPH) Orphazyme A/S (Nasdaq Copenhagen exchange: ORPHA.CO) in exchange for milestone payments and royalties. Orphazyme is testing arimoclomol in four indications including amyotrophic lateral sclerosis (ALS), Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). CytRx Corporation’s website is www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements relating to the proposed transaction involving NantKwest and ImmunityBio and their future success in improving the treatment of various diseases and illnesses. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, such as the risks and uncertainties relating to the ability of NantKwest and ImmunityBio to successfully complete their proposed merger on a timely basis and obtain regulatory approval for their products that use aldoxorubicin; the ability of NantKwest or ImmunityBio to continue their planned preclinical and clinical development of their respective development programs and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions; the ability of NantKwest and ImmunityBio to manufacture and commercialize products or therapies that use aldoxorubicin; the amount, if any, of future milestone and royalty payments that we may receive from NantKwest and ImmunityBio; the results of future studies and trials of cancer treatments and therapies that include aldoxorubicin, including combination immunotherapies; the ability of Orphazyme to obtain regulatory approval for its products that use arimoclomol; the ability of Orphazyme A/S to manufacture and commercialize products or therapies that use arimoclomol; the amount, if any, of future milestone and royalty payments that we may receive from Orphazyme A/S; and other risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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