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 commented on its results for the quarter ended September 30, 2021. In addition, CytRx recapped corporate developments as well as matters pertaining to its agreements with ImmunityBio, Inc. (NASDAQ: IBRX) (“ImmunityBio”) and Orphazyme A/S (NASDAQ:ORPH) ("Orphazyme"). The Company’s 10-Q was filed today.
Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, commented:
"We continued to prudently manage our capital and streamlined operations while awaiting potential developments with respect to Orphazyme’s pursuit of regulatory approval for arimoclomol and ImmunityBio’s Q1 2022 release of Cohort C survival data from its QUILT 88 study, which is a Phase 2 pancreatic cancer trial that includes aldoxorubicin. We continue to believe in the long-term promise of our licensed drugs and Centurion BioPharma."
- CytRx concluded the quarter ended September 30, 2021 with cash and cash equivalents of approximately $16.5 million.
- The Company recorded a net loss of $1.7 million for the quarter ended September 30, 2021, compared to a net loss of $2.8 million for the same period in 2020.
- General and administrative expenses were $1.5 million for the quarter, compared with $2.2 million for the same period in 2020.
- CytRx completed its first liquidated damages payment of $165,000 regarding the $10 million securities purchase agreement with Armistice Capital Master Fund Ltd.
- Until the Company increases its authorized common stock, it will be incurring payments of approximately $0.7 million per quarter.
- On behalf of Centurion BioPharma, Mr. Kriegsman was recently invited to present plans for potentially developing a world-class cancer treatment center in Las Vegas, Nevada.
- In October, Mr. Kriegsman presented at the Virtual LD Micro Main Event XIV.
- In September, Mr. Kriegsman presented at the H.C. Wainwright 23rd Annual Global Investment Conference.
- Mr. Kriegsman and Lead Director Louis Ignarro, PhD continued pursuing strategic partnership opportunities to advance clinical testing for Centurion BioPharma’s assets. Discussions with prospective partners under confidentiality agreements are ongoing. There are no formal updates to report at this time.
- CytRx maintains federal and state net operating loss (“NOL”) carryforwards of $327.6 million and $252.6 million, respectively, available to offset against future taxable income. Of this amount, $258.3 million of federal NOLs and $252.6 million of state NOLs are unrestricted.
- ImmunityBio announced during the quarter the completion of enrollment in its Phase 2 trial studying a combination immunotherapy (Nant Cancer Vaccine) – which includes aldoxorubicin – in advanced metastatic pancreatic cancer.
- According to ImmunityBio, the majority of participants in the study to date remain on therapy and 90% (43/48) of the evaluable patients have exceeded the approximately two-month historical survival rate.
- Earlier this month, Orphazyme issued an encouraging regulatory update following its recently held Type A meeting with the U.S. Food and Drug Administration ("FDA") regarding arimoclomol, a heat shock protein amplifier intended for the treatment of Niemann-Pick disease Type C ("NPC").
- The FDA recommended that Orphazyme submit additional data, information and analyses to address certain topics in the Complete Response Letter and engage in further interactions with the FDA to identify a pathway to resubmission.
- The FDA concurred with Orphazyme's proposal to remove the cognition domain from the NPCCSS endpoint, with the result that the primary endpoint is permitted to be recalculated using the 4-domain NPCCSS, subject to the submission of additional requested information which Orphazyme intends to provide. To bolster the confirmatory evidence already submitted, the FDA affirmed that it would require additional in vivo or pharmacodynamic (PD)/pharmacokinetic (PK) data; Orphazyme is considering the optimal path forward to address the FDA’s requests.
- Orphazyme recently published the results from a Phase 2/3 trial of arimoclomol for NPC in the peer-reviewed Journal of Inherited Metabolic Disease. The online publication is available here.
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. In addition, CytRx’s drug candidate, arimoclomol, was sold to Orphazyme A/S in exchange for milestone payments and royalties. Orphazyme is developing arimoclomol in two indications, including Niemann-Pick disease Type C (NPC), and Gaucher disease. CytRx Corporation’s website is www.cytrx.com.
This press release contains forward-looking statements. 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, including risks and uncertainties relating to the ability of ImmunityBio, Inc., to obtain regulatory approval for its products that use aldoxorubicin; the ability of ImmunityBio, Inc., 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 ImmunityBio, Inc.; Centurion BioPharma Corporation’s ability to develop new ultra-high potency drug candidates based on its LADR™ technology platform; our ability to attract potential licensees; 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.