CytRx Highlights Preliminary Results of Cohort C of QUILT 88, a Phase 2 Pancreatic Cancer Trial That Includes Aldoxorubicin, Expected to be Released in Q1 2022

LOS ANGELES--(BUSINESS WIRE)-- CytRx Corporation (OTCQB: CYTR) ("CytRx" or the “Company”), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today highlighted that ImmunityBio, Inc. (NASDAQ: IBRX) (“ImmunityBio”) has been granted a patent by the U.S. Patent and Trademark Office for its proprietary NANT Cancer Vaccine (U.S. Patent 11,071,774). ImmunityBio’s investigational treatment for cancer is designed to bolster a patient’s own immune response to cancerous cells, augment that response with additional natural killer and T-cell therapies to overcome the cancer’s resistance, and induce long-term T-cell memory to induce remission across multiple tumor types.

As previously disclosed, 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.

To study the safety and early efficacy signals across multiple tumor types, ImmunityBio has launched a series of Quantitative Lifelong Trials (QUILT). To date, the vaccine has been studied in more than 100 patients across multiple tumor types, including pancreatic, breast, colorectal, and head and neck cancers. Among these studies is QUILT 88, a Phase 2 trial that includes Aldoxorubicin and is studying the vaccine in metastatic pancreatic cancer patients. Enrollment of Cohort C, which includes Aldoxorubicin and patients who have previously failed two lines of standard-of-care therapy, is expected to be completed in the third quarter of 2021 and an early readout of survival data is expected in the first quarter of 2022.

ImmunityBio’s Founder and Executive Chairman made the following statement this week:

“We are excited to be developing this orchestrated approach to activate as many elements of the immune system that we can and overcome cancer’s ability to evade the immune system. Our hypothesis is that by revealing tumor antigens to the immune system, we activate tumor-specific T cells and targeted natural killer cells to eradicate tumors by what is known as immunogenic cell death. The issuance of the NANT Cancer Vaccine patent is recognition of this innovative approach to therapy that not only potentially provides long-term immune system protection from cancer, it does so with a reduced risk of the toxicity risk that comes with using high-dose chemotherapy and radiation. This closely aligns with the FDA’s recent ‘Project Optimist’ guidelines for exploring lower doses of therapeutic agents.”

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

“CytRx is very encouraged by ImmunityBio’s receipt of a U.S. patent for this novel immunotherapy vaccine that has been utilizing Aldoxorubicin in its pancreatic cancer trials. We continue to believe that Aldoxorubicin can be a foundational component of ImmunityBio’s innovative cancer treatments.”

About CytRx

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 recent advanced drug conjugate, Aldoxorubicin, is an improved version of the widely used anti-cancer drug doxorubicin and has been out-licensed to ImmunityBio, Inc. (NASDAQ: IBRX). In addition, CytRx's drug candidate, arimoclomol, was sold to Orphazyme A/S (Nasdaq: ORPH) in exchange for milestone payments and royalties. Orphazyme is developing arimoclomol in Niemann-Pick disease Type C ("NPC") and Gaucher disease. Learn more at www.cytrx.com.

Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of CytRx nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and CytRx’s ability to, obtain and maintain regulatory approvals for clinical trials of CytRx’s pharmaceutical candidates; the timing and results of CytRx’s planned clinical trials for its pharmaceutical candidates; the amount of funds CytRx requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which CytRx operates; CytRx’s ability to retain and attract senior management and other key employees; CytRx’s ability to quickly and effectively respond to new technological developments; CytRx’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on CytRx’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on CytRx’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to CytRx is set forth in the most recent annual and quarterly reports filed by the CytRx with the SEC, including disclosures under the heading “Risk Factors”, and current reports filed since the date of the CytRx’s most recent annual report. All forward-looking statements are based upon information available to the 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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