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Monday, October 18, 2021

Arimoclomol Clinical Trials; the Rise of CytRx Corporation (OTCMKTS: CYTR)

CytRx Corporation (OTCMKTS: CYTR) is making a powerful run up the charts recently surpassing $1 and recent previous highs and embarking on a blue sky breakout. Volume has picked up with CYTR regularly topping the $2 million USD dollar mark in daily dollar volume. Investors remember the big run CYTX made in 2014 helped along by SeekingAlpha articles. The articles and author profile pages were removed after investigation by CNNMoney and aclass action lawsuit was filed against CytRx. The events leading to CytRx lawsuits were revealed by a Seeking Alpha author named Richard Pearson who was shorting the CytRx company stock and the “short attack” was revealed by another Seeking Alpha author PhD. who wrote about the science of aldoxorubicin and revealed the motives behind Richard Pearson’s article to short the company’s stock.

CytRx has a milestone and royalty agreement with Orphazyme A/S for arimoclomol. The agreement can provide CytRx with up to $120M in potential milestones + royalties paid on arimoclomol. Orphazyme is currently studying arimoclomol in clinical trials for 4 indications including Nieman-Pick Disease Type C (NPC), amyotrophic lateral sclerosis (ALS), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). Recently, Orpahzyme announced encouraging clinical trial data with arimoclomol in NPC. NPC is a severely debilitating and fatal disease that predominantly affects children. Orphazyme has received FDA Breakthrough Therapy Designation for arimoclomol for NPC.  CytRx’s agreement with ImmunityBio can deliver up to $343 million in potential milestones and future royalties paid on sales of aldoxorubicin’s use for multiple tumor types.

CytRx Corporation (OTCMKTS: CYTR) is a biopharmaceutical company with expertise in discovering and developing new therapeutics principally to treat patients with cancer and neurodegenerative diseases. CytRx’s drug candidate, arimoclomol, was sold to Orphazyme A/S (Nasdaq Copenhagen exchange: ORPHA.CO) in exchange for milestone payments and royalties. Orphazyme is developing arimoclomol in four indications including Amyotrophic Lateral Sclerosis (“ALS”), Niemann-Pick Disease Type C (“NPC”), Gaucher disease and sporadic Inclusion Body Myositis (“sIBM”).

CytRx has a milestone and royalty agreement with Orphazyme A/S for arimoclomol. The agreement can provide CytRx with up to $120M in potential milestones + royalties paid on arimoclomol. Orphazyme is currently studying arimoclomol in clinical trials for 4 indications including Nieman-Pick disease Type C (NPC), amyotrophic lateral sclerosis (ALS), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). Recently, Orpahzyme announced encouraging clinical trial data with arimoclomol in NPC. NPC is a severely debilitating and fatal disease that predominantly affects children. Orphazyme has received FDA Breakthrough Therapy Designation for arimoclomol for NPC. They have announced they will be submitting a New Drug Application (NDA) with the FDA in the first half of 2020 and a Marketing Authorization Application with the European Medicines Agency (EMA) in the second half of 2020. Orphazyme is a biopharmaceutical company focused on bringing novel treatments to patients living with life threatening or debilitating rare diseases.

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CytRx also has a milestone and royalty agreement with NantCell, Inc. (now called ImmunityBio, Inc.) for aldoxorubicin which is an improved version of the widely used chemotherapeutic agent doxorubicin. The agreement can provide CytRx with up to $343M in potential milestones + royalties paid on aldoxorubicin. Royalties are increasing double digits on soft tissue sarcomas and increasing single digits in all other indications. ImmunityBio is headed by Dr. Patrick Soon-Shiong, the inventor of Abraxane and an albumin research pioneer in oncology. ImmunityBio is developing aldoxorubicin in multiple phase 1b/2 trials in tumors of very high unmet need including pancreatic cancer, head and neck cancer, triple negative breast cancer and colorectal cancer.

On December 7 CYTR highlighted that Orphazyme A/S (NASDAQ: ORPH) (“Orphazyme”) has announced the expansion of its U.S. presence and workforce ahead of potential FDA approval of arimoclomol for the treatment of Niemann-Pick disease Type C (“NPC”). CytRx has an agreement with Orphazyme that can yield potential milestone payments and future royalties paid on sales of arimoclomol. In addition to establishing its U.S. headquarters in Chicago, Orphazyme has already recruited more than 30 U.S. employees. Orphazyme has also named three U.S. leaders to its global executive team: Molly Painter, U.S. President, is heading the launch and commercial operations in the market. Terri Stevens, Chief Business Officer, is responsible for global strategy, corporate development, and business development and licensing, and Molly Carey Poarch, Global and U.S. Head of Corporate Communications.

Orphazyme’s U.S. team, which is focused on regulatory review efforts and a first potential commercial launch in 2021, includes legal, commercial, finance, advocacy relations, and regulatory and medical affairs functions.

Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, commented: “We are very pleased to see Orphazyme establish a strong U.S. footprint by investing in headquarters in Chicago and retaining more than 30 employees ahead of potential commercialization of arimoclomol for NPC upon prospective FDA approval in the first quarter of 2021. In our view, Orphazyme is taking the right steps to begin future distribution and deepen engagement with U.S. providers, patients, regulators, and the clinical testing community in 2021. It is also noteworthy that during the year 2021, Orphazyme may receive a response to its submission for regulatory approval in Europe for arimoclomol to treat NPC. Also, on or before June 30, 2021, Orphazyme is expected to report Phase 3 data on arimoclomol for sporadic Inclusion Body Myositis and Amyotrophic Lateral Sclerosis. We remain optimistic about Orphazyme’s continued progress.”

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CYTR is making a powerful run up the charts recently surpassing $1 and recent previous highs and embarking on a blue sky breakout. Volume has picked up with CYTR regularly topping the $2 million USD dollar mark in daily dollar volume. Investors remember the big run CYTX made in 2014 helped along by SeekingAlpha articles. The articles and author profile pages were removed after investigation by CNNMoney and aclass action lawsuit was filed against CytRx. The events leading to CytRx lawsuits were revealed by a Seeking Alpha author named Richard Pearson who was shorting the CytRx company stock and the “short attack” was revealed by another Seeking Alpha author PhD. who wrote about the science of aldoxorubicin and revealed the motives behind Richard Pearson’s article to short the company’s stock. CytRx has a milestone and royalty agreement with Orphazyme A/S for arimoclomol. The agreement can provide CytRx with up to $120M in potential milestones + royalties paid on arimoclomol. Orphazyme is currently studying arimoclomol in clinical trials for 4 indications including Nieman-Pick Disease Type C (NPC), amyotrophic lateral sclerosis (ALS), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). Recently, Orpahzyme announced encouraging clinical trial data with arimoclomol in NPC. NPC is a severely debilitating and fatal disease that predominantly affects children. Orphazyme has received FDA Breakthrough Therapy Designation for arimoclomol for NPC.  CytRx’s agreement with ImmunityBio can deliver up to $343 million in potential milestones and future royalties paid on sales of aldoxorubicin’s use for multiple tumor types. Niemann-Pick Disease Type C (NPC) is a rare, genetic and progressive disease that impairs the ability of the body to move cholesterol and other fatty substances (lipids) inside the cells. We will be updating on CYTR when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYTR.

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Disclosure: we hold no position in CYTR either long or short and we have not been compensated for this article.

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