ORPH Orphazyme A/S

3.91
-0.21  -5%
Previous Close 4.12
Open 4.05
52 Week Low 3.78
52 Week High 77.77
Market Cap $136,663,262
Shares 34,952,241
Float 34,952,241
Enterprise Value $102,904,241
Volume 1,455,870
Av. Daily Volume 1,921,767
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
Arimoclomol
Niemann-Pick disease Type C (NPC)
CRL
CRL
CRL issued June 18, 2021.
Arimoclomol
Amyotrophic Lateral Sclerosis
Phase 3
Phase 3
Phase 3 data trial did not meet primary endpoint - May 7, 2021.
Arimoclomol
Sporadic Inclusion Body Myositis
Phase 2/3
Phase 2/3
Phase 2/3 trial did not meet primary endpoint - March 29, 2021.

Latest News

  1. 12-Month Study of Arimoclomol Showed a Clinically Meaningful Treatment Effect, Corresponding to a Reduction in Disease Progression

    Highlights Arimoclomol is Under Regulatory Review in Europe, With a Decision Expected in Q4 2021

    Notes Orphazyme Stated it Continues to Evaluate a Path Forward for Arimoclomol in the U.S.

    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 Orphazyme A/S (NASDAQ:ORPH) ("Orphazyme") published the results from a Phase 2/3 trial of arimoclomol, an investigational heat-shock protein amplifier, in Niemann-Pick disease type C (NPC) in the peer-reviewed…

    12-Month Study of Arimoclomol Showed a Clinically Meaningful Treatment Effect, Corresponding to a Reduction in Disease Progression

    Highlights Arimoclomol is Under Regulatory Review in Europe, With a Decision Expected in Q4 2021

    Notes Orphazyme Stated it Continues to Evaluate a Path Forward for Arimoclomol in the U.S.

    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 Orphazyme A/S (NASDAQ:ORPH) ("Orphazyme") published the results from a Phase 2/3 trial of arimoclomol, an investigational heat-shock protein amplifier, in Niemann-Pick disease type C (NPC) in the peer-reviewed Journal of Inherited Metabolic Disease (JIMD). The online publication is available here.

    The Phase 2/3 trial (NPC-002; ClinicalTrials.gov identifier: NCT02612129), was a prospective, randomized, double-blind, placebo-controlled study. Fifty patients aged 2–18 years were randomized 2:1 to arimoclomol:placebo, stratified by miglustat use. Routine clinical care was maintained. Arimoclomol was administered orally three times daily. The primary endpoint was change in 5-domain NPC Clinical Severity Scale (NPCCSS) score from baseline to 12 months, as described by Mengel et al.1 and Patterson et al2. The 5-domain NPCCSS comprises the domains determined to be most clinically relevant to patients, caregivers, and clinicians: ambulation, cognition, fine motor skills, speech, and swallowing (Cortina-Borja et al.3). A recent validation of the 5-domain NPCCSS shows that a change of 1 point or greater on the total score constitutes a clinically meaningful change for caregivers/patients and physicians (Patterson et al4).

    At 12-months, a significant treatment effect in favor of arimoclomol of −1.40 points (95% CI: −2.76, −0.03; p = 0.046) was observed, corresponding to a 65% relative reduction in annual disease progression. In the prespecified subgroup of patients receiving miglustat as routine care, arimoclomol resulted in stabilization of disease severity with a treatment difference of −2.06 in favor of arimoclomol (p = 0.006). In the pre-specified subgroup of patients ≥4 years of age the mean treatment difference was −1.80 in favor of arimoclomol (p=0.016), corresponding to 82% relative reduction in annual disease progression.

    Arimoclomol was well-tolerated, with adverse events occurring in 88.2% of patients receiving arimoclomol and 75.0% of patients receiving placebo. Fewer patients had serious adverse events with arimoclomol (14.7%) versus placebo (31.3%).

    Orphazyme's Chief Medical Officer stated the following in an announcement this week:

    "We are pleased to share the data from our Phase 2/3 trial in JIMD. NPC is a rare, inherited progressive neurodegenerative disorder with a high unmet medical need for disease-modifying treatment options. This trial demonstrated a statistically significant and clinically meaningful treatment effect of arimoclomol in NPC supported by significant and consistent effects across several disease- and pharmacodynamic biomarkers. We believe these data establish the potential of arimoclomol as an efficacious and well-tolerated disease-modifying treatment for NPC."

    Orphazyme's Chief Executive Officer added the following in an announcement this week:

    "We are committed to serving the NPC community and are working expeditiously to deliver this potential new medicine to patients. Arimoclomol is under regulatory review in Europe, with an anticipated CHMP opinion in Q4 2021, and we continue to evaluate the path forward in the U.S. following the recent FDA response."

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

    "CytRx is encouraged by Orphazyme's published results of its Phase 2/3 trial of arimoclomol in Niemann-Pick disease type C, which exhibited a statistically significant and clinically meaningful treatment effect on reducing disease progression. The biomarker data further suggests arimoclomol can be an effective solution for young patients suffering from NPC, with relatively few serious adverse effects. We look forward to monitoring Orphazyme's pursuit of European regulatory approval for arimoclomol in Q4 2021 and additional developments in the U.S. following the FDA's feedback."

    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 contains forward-looking statements. These statements are not historical facts, but instead represent only CytRx's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of CytRx's control. Forward-looking statements include statements relating to the potential receipt of EMA and FDA approval of arimoclomol and the CytRx's potential receipt of future milestone and royalty payments from Orphazyme. 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 Orphazyme to obtain regulatory approval for, manufacture and commercialize its products and therapies that use arimoclomol; the results of clinical trials involving arimoclomol; the amount, if any, of future milestone and royalty payments that we may receive from Orphazyme; and other risks and uncertainties described 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. The CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    ____________________

    1 Mengel E, Bembi B, Del Toro M, et al (2020) Clinical disease progression and biomarkers in Niemann–Pick disease type C: a prospective cohort study. Orphanet J Rare Dis 15: 328.

    2 Patterson MC, Lloyd-Price L, Guldberg C, et al (2021) Validation of the 5-domain Niemann-Pick type C Clinical Severity Scale. Orphanet J Rare Dis 16: 79.

    3 Cortina-Borja M, Vruchte D, Mengel E, et al (2018) Annual severity increment score as a tool for stratifying patients with Niemann-Pick disease type C and for recruitment to clinical trials. Orphanet J Rare Dis 13: 143. doi:110.1186/s13023-13018-10880-13029.

    4 Patterson MC, Lloyd-Price L, Guldberg C, et al (2021) Validation of the 5-domain Niemann-Pick type C Clinical Severity Scale. Orphanet J Rare Dis 16: 79.

    View Full Article Hide Full Article
  2. 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 second quarter ended June 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 took important steps to enhance our capital position and further strengthen our corporate governance during the second quarter. By raising gross proceeds of $10…

    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 second quarter ended June 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 took important steps to enhance our capital position and further strengthen our corporate governance during the second quarter. By raising gross proceeds of $10 million from our recent financing, we have obtained valuable working capital that can help us maintain stability as we efficiently manage our portfolio of licensing agreements and high-potential assets. We continue to believe in the long-term promise of our licensed drugs and Centurion Biopharma. We look forward to monitoring Orphazyme's pursuit of European regulatory approval for arimoclomol in Q4 2021 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."

    First Quarter Financial Overview

    • CytRx concluded the quarter ended June 30, 2021 with cash on hand of approximately $8.4 million.
    • The Company recorded a net loss of $1.2 million for the quarter ended June 30, 2021, compared to a net loss of $1.3 million for the same period in 2020.
      • General and administrative expenses were $1.2 million for the quarter, compared with $1.4 million for the same period in 2020.

    Recent Developments

    Corporate Highlights

    • Last month, CytRx entered into a securities purchase agreement with a healthcare-focused institutional investor, resulting in aggregate gross proceeds of approximately $10 million. The investor is independent of the Company's Board of Directors and management team. The Company intends to use the net proceeds for working capital purposes.
    • Last month, Jennifer K. Simpson, Ph.D joined the Company's Board of Directors. Dr. Simpson is the Chief Executive Officer and a Director of Panbela Therapeutics Inc. (NASDAQ:PBLA), a clinical stage drug development company. Shortly after joining Panbela Therapeutics, Dr. Simpson led a public financing with an uplist to the NASDAQ exchange. She has more than 13 years' experience in pharmaceutical executive leadership, global marketing and product commercialization.
    • With respect to Centurion Biopharma, Mr. Kriegsman and Lead Director Louis Ignarro, PhD continued pursuing strategic partnership opportunities to advance clinical testing for the platform'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 Highlights

    • ImmunityBio announced during the quarter that Cohort C of its QUILT 88 study in pancreatic cancer, 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. An early readout of survival data is expected in the first quarter of 2022.

    Orphazyme Highlights

    • Orphazyme announced during the quarter that it received a Complete Response Letter ("CRL") from the Food and Drug Administration ("FDA") following its review of the new drug application for arimoclomol. Orphazyme disclosed that the FDA issued the CRL based on needing additional evidence to further substantiate the validity and interpretation of the 5-domain NPC Clinical Severity Scale and, in particular, the swallow domain. Further, the FDA noted in the CRL that additional data is needed to bolster confirmatory evidence beyond the single phase 2/3 clinical trial to support the benefit-risk assessment of the NDA.
    • Subsequently, Orphazyme announced 24-month interim results of an open-label extension ("OLE") trial of arimoclomol for the treatment of NPC. Orphazyme provided efficacy and safety data for its investigational treatment arimoclomol in NPC for up to 36 months. The results demonstrate that arimoclomol provided a sustained benefit to study participants by reducing NPC progression as measured by the 5-domain NPC Clinical Severity Scale (5D-NPCCSS).
    • Orphazyme is expecting prospective European regulatory approval for arimoclomol in the treatment of NPC by the end of 2021.

    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 contains forward-looking statements. These statements are not historical facts, but instead represent only CytRx's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of CytRx's control. Forward-looking statements include statements relating to the potential receipt of EMA and FDA approval of arimoclomol and the CytRx's potential receipt of future milestone and royalty payments from Orphazyme. 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 Orphazyme to obtain regulatory approval for, manufacture and commercialize its products and therapies that use arimoclomol; the results of clinical trials involving arimoclomol; the amount, if any, of future milestone and royalty payments that we may receive from Orphazyme; and other risks and uncertainties described 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. The CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    View Full Article Hide Full Article
  3. New Director Dr. Jennifer K. Simpson Added to CytRx Board of Directors

    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 announced that based on results from its 2021 Annual Meeting of Stockholders (the "Annual Meeting"), both of the Company's Class III director candidates – Joel K. Caldwell, CPA and Jennifer K. Simpson, Ph.D. – have been elected to the Board of Directors (the "Board"). Additional information pertaining to the Company's Annual Meeting results can be found on the Form 8-K filed with the U.S. Securities and Exchange Commission.

    Steven A. Kriegsman, Chairman and Chief Executive…

    New Director Dr. Jennifer K. Simpson Added to CytRx Board of Directors

    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 announced that based on results from its 2021 Annual Meeting of Stockholders (the "Annual Meeting"), both of the Company's Class III director candidates – Joel K. Caldwell, CPA and Jennifer K. Simpson, Ph.D. – have been elected to the Board of Directors (the "Board"). Additional information pertaining to the Company's Annual Meeting results can be found on the Form 8-K filed with the U.S. Securities and Exchange Commission.

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

    "We appreciate our stockholders' participation at this year's Annual Meeting. By electing Mr. Caldwell and Dr. Simpson to the Board, our stockholders have helped to strengthen CytRx's corporate governance. The addition of Dr. Simpson as a new director reflects our commitment to refreshing the Board with diverse perspectives and valuable industry experience."

    Dr. Simpson added:

    "I look forward to working with Mr. Kriegsman and the rest of the Board to advance stockholders' best interests. Given my extensive experience in the biopharmaceutical and oncology sectors, I see opportunities to add value as the Board explores new initiatives and partnership opportunities. I believe CytRx has high-potential assets that can become a source of enduring value for stockholders."

    New Director Biography:

    Jennifer K. Simpson, Ph.D. is the Chief Executive Officer and a Director of Panbela Therapeutics Inc. (NASDAQ:PBLA), a clinical stage drug development company. Shortly after joining, Dr. Simpson led a public financing with an uplist to the NASDAQ exchange. She has more than 13 years' experience in pharmaceutical executive leadership, global marketing and product commercialization. Previously, Dr. Simpson was the Chief Executive Officer and a Director of Delcath Systems Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancer. From 2008 to 2012, Dr. Simpson served in various product leadership roles, including Vice President, Global Marketing, Oncology Brand Lead at ImClone Systems, Inc. (a wholly owned subsidiary of Eli Lilly and Company (NYSE: LLY)). While in this role, she led the largest registration program pre-approval in Oncology for a VEGFR-2 monoclonal antibody including initiation and oversight of six phase 3 trials across five indications as well as a robust phase 2 program. Dr. Simpson earned a Ph.D. in Epidemiology from the University of Pittsburgh, a M.S. in Nursing from the University of Rochester, and a B.S. in Nursing from the State University of New York at Buffalo.

    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.

    View Full Article Hide Full Article
  4. ImmunityBio's Receipt of U.S. Patent for Novel Immunotherapy, NANT Cancer Vaccine, Being Studied in Multiple Clinical Trials

    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…

    ImmunityBio's Receipt of U.S. Patent for Novel Immunotherapy, NANT Cancer Vaccine, Being Studied in Multiple Clinical Trials

    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.

    View Full Article Hide Full Article
  5. 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 announced the closing of its previously announced sale of its securities pursuant to a securities purchase agreement (the "Purchase Agreement") to a single healthcare-focused institutional investor (the "Investor") for aggregate gross proceeds of approximately $10 million. The Investor is independent of the Company's Board of Directors and management team. The Company intends to use the net proceeds of the offering for working capital purposes.

    Under the terms of the Purchase Agreement, CytRx sold 2,000,000 shares of its common stock at a purchase…

    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 announced the closing of its previously announced sale of its securities pursuant to a securities purchase agreement (the "Purchase Agreement") to a single healthcare-focused institutional investor (the "Investor") for aggregate gross proceeds of approximately $10 million. The Investor is independent of the Company's Board of Directors and management team. The Company intends to use the net proceeds of the offering for working capital purposes.

    Under the terms of the Purchase Agreement, CytRx sold 2,000,000 shares of its common stock at a purchase price of $0.88 per share for total gross proceeds of approximately $1.76 million in a registered direct offering and 8,240 shares of Series C 10.00% Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share for total gross proceeds of approximately $8.24 million, in a concurrent private placement. The shares of the Preferred Stock are convertible, upon shareholder approval as described below, into an aggregate of up to 9,363,637 shares of common stock at a conversion price of $0.88 per share. The Preferred Stock includes beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company's outstanding shares of common stock.

    CytRx also issued to the Investor an unregistered preferred investment option (the "Investment Option") that allows for the purchase of up to 11,363,637 shares of common stock for additional gross proceeds of approximately $10 million if the Investment Option is exercised in full. The exercise price for the Investment Option is $0.88 per share. The Investment Option has a term equal to five and one-half years commencing upon the Company increasing its authorized common stock following shareholder approval (the "Authorized Share Increase").

    H.C. Wainwright & Co. acted as exclusive placement agent for the offering.

    As described above, the issuance of the shares of common stock underlying the Preferred Stock and the Investment Option sold in the private placement is subject to the Authorized Share Increase. Pursuant to the Purchase Agreement, the Company must hold a meeting of its stockholders no later than September 25, 2021 to seek shareholder approval.

    The shares of common stock sold in the registered direct offering were offered and sold in the registered direct offering by CytRx pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255431), including a base prospectus, previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on July 12, 2021. The registered direct offering was made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering has been filed with the SEC and is available on the SEC's website located at http://www.sec.gov. Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained from H.C. Wainwright & Co., 430 Park Avenue, New York, NY 10022 or via telephone at (212) 856-5711 or email at placements@hcwco.com.

    The Series C Preferred Stock and Investment Options sold in the private placement and the shares of common stock issuable thereunder were offered pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and have not been registered under the Act, or applicable state securities laws, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale, would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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 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 certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only CytRx's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of CytRx's control. Forward-looking statements include those relating to the offering of CytRx's securities, including as to the expected use of proceeds from the offering described above and adverse changes in general economic and market conditions. Forward-looking statements also include statements relating to the potential receipt of EMA and FDA approval of arimoclomol, the CytRx's potential receipt of future milestone and royalty payments from Orphazyme and the achievement of long-term value for the CytRx's stockholders. 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 Orphazyme to obtain regulatory approval for, manufacture and commercialize its products and therapies that use arimoclomol; the results of clinical trials involving arimoclomol; the amount, if any, of future milestone and royalty payments that we may receive from Orphazyme; and other risks and uncertainties described 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. The CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    View Full Article Hide Full Article
View All Orphazyme A/S News