LOS ANGELES, March 29, 2019 /PRNewswire/ -- CytRx Corporation CYTR, a biopharmaceutical research and development company specializing in oncology, today announced financial results for the full year ended December 31, 2018 and provided an overview of recent accomplishments and plans for its research and development programs.
"During late 2018 and early 2019, our core focus has been on working to secure a strategic partnership for our albumin binding ultra high potency LADR™ (Linker Activated Drug Release) assets and the accompanying albumin companion diagnostic (ACDx)," said Eric Curtis, CytRx's President and Chief Operating Officer. "As part of that effort, we have been publishing and raising awareness around the important data generated by Dr. Felix Kratz and his team. With the conclusion of the LADR™ pre-clinical phase in late 2018, our cash burn has been significantly reduced, allowing for a longer runway as we work to execute on our corporate objectives. In parallel, we are pleased to see positive momentum by our asset licensees, NantCell and Orphazyme A/S.
Fourth Quarter 2018 and Recent Highlights
Centurion BioPharma Corporation
- ACDx Manuscript Published in the Journal Nuclear Medicine and Molecular Imaging. In March 2019, peer reviewed, scientific research for Centurion's ACDx was published online in the journal Nuclear Medicine and Molecular Imaging. The manuscript, titled "Development of a Novel Imaging Agent for Determining Albumin Uptake in Solid Tumors," can be accessed and purchased online at https://doi.org/10.1007/s13139-019-00587-w.
- LADR-7 Scientific Research Published as Cover Story in the Journal of Controlled Release. In February 2019, peer reviewed, scientific research for LADR-7 (AE-Keto-Sulf07), one of Centurion's lead LADR™ candidates, was published as a cover story in the Journal of Controlled Release, a leading journal for drug delivery. The article, titled "Novel auristatin E-based albumin-binding prodrugs with superior anticancer efficacy in vivo compared to the parent compound," can be accessed and purchased online at https://www.sciencedirect.com/journal/journal-of-controlled-release/vol/296.
- Highlighted Important OncLive® Article Citing Majority of Cancer Patients Do Not Have Targetable Genetic Mutations. In February 2019, Centurion highlighted an OncLive® article citing that 65% of oncology patients do not have targetable genetic mutations that would make them eligible for targeted treatment and are therefore candidates for chemotherapy. Centurion's core focus is on developing its LADR™ drug candidates, which have the potential to improve efficacy and safety of cytotoxics by targeting ultra-high potency drug delivery directly inside the tumor.
- Concluded Pre-Clinical Phase for Albumin Binding Ultra High Potency LADR™ Drug Candidates and Accompanying Companion Diagnostic. In December 2018, the Company concluded the pre-clinical phase of development for its albumin binding ultra high potency LADR™ drug candidates, LADR-7, LADR-8, LADR-9 and LADR-10, and for its unique ACDx. The critical preclinical steps were achieved and each of these pipeline assets are now eligible for IND-enabling studies. As a result, Centurion reduced its cash burn and will utilize its financial resources for other opportunities while working to secure a strategic transaction for the LADR™ and ACDx assets, with the goal of executing such a transaction as soon as possible.
- Highlighted Certain Key Emerging Oncology Trends Which Strengthen the Potential of the Rationally Designed LADR™ Assets. In October 2018, the Company highlighted that key emerging cancer treatment trends by big pharma, including combining immunotherapy with effective chemotherapy regimens, are resulting in significant advancements for the treatment of patients with high unmet medical need types of cancer. The Company believes these trends strengthen and enhance the value proposition for their rationally designed, albumin binding ultra-high potency LADR™ assets. Collectively the SITC data showed that Nant Cancer Vaccine (NCV) therapy is well tolerated with encouraging early signals of efficacy.
CytRx Corporation
- Arimoclomol Licensee Orphazyme A/S Reports Positive Phase 2/3 Clinical Data in Niemann Pick Disease Type C (NPC). In February 2019, CytRx highlighted positive Phase 2/3 clinical trial data reported by arimoclomol licensee Orphazyme A/S ORPHA in NPC. In this full data set analysis, arimoclomol showed a 74% reduction in disease progression after 12 months compared to placebo control (p-value=0.0506), the primary endpoint of the trial. Should arimoclomol be approved for NPC in the U.S. and Europe, CytRx is eligible to receive $10 million in milestone payments, plus royalties.
- Aldoxorubicin included in New NantCell Inc. Colorectal Cancer Clinical Trial. In January 2019, CytRx highlighted that aldoxorubicin licensee NantCell, Inc., has dosed the first patient in the Phase 1b portion of a Phase 1b/2 clinical trial for patients with relapsed or refractory colorectal cancer (CRC) who have been previously treated with standard of care (SOC) therapy. This is the fourth trial conducted by NantCell which will investigate high-affinity natural killer (haNK) cell therapy in combination with anti-cancer agents, including aldoxorubicin, in certain high unmet need cancer indications.
- NantCell Inc's Presented Aldoxorubicin Clinical Data at the Society for Immunotherapy of Cancer (SITC)'s 33rd Annual Meeting. In November 2018, CytRx highlighted two poster presentations by aldoxorubicin licensee NantCell, Inc. at SITC. The presentations describe positive safety and efficacy data from the Phase 1b portion of Phase 1b/2 clinical trials evaluating NantCell's high-affinity natural killer (haNK) cell therapy in combination with anti-cancer agents, including aldoxorubicin, in patients with third-line or greater triple negative breast cancer (TNBC), fourth-line or greater head and neck squamous cell carcinoma (HNSCC) or recurrent metastatic pancreatic cancer.
Full Year 2018 Financial Results
CytRx reported cash and cash equivalents of $21.4 million as of December 31, 2018.
With the closing of the Freiburg lab operations, CytRx treated the expenses of those operations as discontinued operations in both 2018 and 2017.
Net loss for the year ended December 31, 2018, was $12.7 million, or $(0.41) per share, compared with a net loss of $35.0 million, or $(1.46) per share, for the comparative 2017 period, a reduction of $22.2 million, or approximately 63 percent. This included a loss from discontinued operations of $3.6 million in 2018 as compared to $4.5 million in 2017.
Research and development (R&D) expenses were minimal for 2018 as compared to $15.8 million for 2017.
General and administrative (G&A) expenses were $8.1 million for 2018 compared with $12.5 million for 2017. G&A expenses decreased by approximately 35 percent primarily due to a decrease in professional fees and a reduction in employees.
Based on our currently projected expenditures for the year, we have reduced our burn rate to approximately $500,000 per month.
About CytRx Corporation
CytRx Corporation CYTR is a biopharmaceutical company with expertise in discovering and developing new therapeutics to treat patients with cancer. CytRx's most advanced drug conjugate, aldoxorubicin, is an improved version of the widely used anti-cancer drug doxorubicin and has been out-licensed to NantCell, Inc. In addition, CytRx's other drug candidate, arimoclomol has been out-licensed to Orphazyme A/S (Nasdaq Copenhagen exchange: ORPHA). 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.
About Centurion Corporation
CytRx's wholly owned subsidiary, Centurion BioPharma Corporation, is focused on the development of personalized medicine that is designed to transform solid tumor treatment. This transformational strategy combines a portfolio of novel, anti-cancer drug candidates that employ LADR™ (Linker Activated Drug Release) technology, a discovery engine designed to leverage Centurion's expertise in albumin biology and linker technology for the development of a new class of breakthrough anti-cancer therapies with a unique albumin companion diagnostic (ACDx) that can help identify patients who are most likely to benefit from treatment with the LADR™-derived therapies. A critical element of the LADR™ platform is its ability to bind anti-cancer molecules to circulating albumin, the most ubiquitous protein in human blood plasma, and then to release the highly potent cytotoxic payload at the tumor site. This technology allows for the delivery of higher doses of drug directly to the tumor, while avoiding much of the off-target toxicity observed with the parent molecules. Centurion BioPharma Corporation's website is www.centurionbiopharma.com.
Forward-Looking Statements
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 Centurion BioPharma to enter into strategic transactions or partnerships involving its proprietary LADR™ drug candidates; the ability of Centurion's LADR™ drug candidates to enter clinical trials or obtain regulatory approvals for any such products; the efficacy, safety and results of any clinical trials involving Centurion's LADR™ drug candidates; the ability of Centurion to develop new ultra-high potency drug candidates based on its LADR™ technology platform and attract potential licensees; the ability of NantCell to obtain regulatory approval, manufacture and commercialize its products and therapies that use aldoxorubicin; the ability of NantCell to enroll additional patients in clinical trials for aldoxorubicin; the amount, if any, of future milestone and royalty payments that we may receive from NantCell; the ability of Orphazyme A/S to obtain regulatory approval for, manufacture and commercialize its products and therapies that use arimoclomol; the results of future clinical trials involving 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.
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
cytrx@argotpartners.com
CYTRX CORPORATION | |||
CONSOLIDATED BALANCE SHEETS | |||
December 31, | |||
2018 | 2017 | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 21,373,273 | $ 37,497,691 | |
Receivables | 148,527 | 7,504,756 | |
Prepaid expenses and other current assets | 913,162 | 1,914,077 | |
Current assets held for sale | 81,182 | 169,989 | |
Total current assets | 22,516,144 | 47,086,513 | |
Equipment and furnishings, net | 44,326 | 71,466 | |
Goodwill | — | 183,780 | |
Other assets | 40,642 | 22,933 | |
Non-current assets held for sale | 324,853 | 982,827 | |
Total assets | $ 22,925,965 | $ 48,347,519 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable | $ 1,234,762 | $ 4,065,998 | |
Accrued expenses and other current liabilities | 726,191 | 7,881,766 | |
Deferred revenue | — | 6,924,353 | |
Term loan, net - current | — | 10,599,795 | |
Warrant liabilities | — | 527,025 | |
Current liabilities for sale | 602,713 | 203,527 | |
Total current liabilities | 2,563,666 | 30,202,464 | |
Commitment and contingencies | |||
Stockholders' equity: | |||
Preferred Stock, $0.01 par value, 833,334 shares authorized, including 4,167 shares of Series A Junior Participating Preferred Stock; no shares issued and outstanding at December 31, 2018 and 2017, respectively | — | — | |
Preferred Stock, $0.01 par value, stated value $1,000, 650 shares authorized of Series B Convertible Preferred Shares at $2.52 per share, no shares issued and outstanding at December 31, 2018 and 2017. | — | — | |
Common stock, $0.001 par value, 41,666,667 shares authorized; 33,637,501 and 28,037,501 shares issued and outstanding at December 31, 2018 and 2017, respectively | 33,637 | 28,037 | |
Additional paid-in capital | 477,192,747 | 468,969,445 | |
Accumulated deficit | (456,864,085) | (450,852,427) | |
Total stockholders' equity | 20,362,299 | 18,145,055 | |
Total liabilities and stockholders' equity | $ 22,925,965 | $ 48,347,519 | |
CYTRX CORPORATION | |||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||
Years Ended December 31, | |||
2018 | 2017 | ||
Revenue: | |||
Licensing revenue | $ 250,000 | $ 100,000 | |
Expenses: | |||
Research and development | 388,841 | 15,847,722 | |
General and administrative | 8,079,861 | 12,502,042 | |
Depreciation and amortization | 29,423 | 106,989 | |
8,498,125 | 28,456,753 | ||
Loss before other income (expense) | (8,248,125) | (28,356,753) | |
Other income (expense): | |||
Interest income | 355,558 | 365,584 | |
Interest expense | (1,715,733) | (3,831,211) | |
Other income (expense), net | 2,676 | 6,998 | |
Gain on warrant liabilities | 527,025 | 1,367,777 | |
Loss before provision for income taxes | (9,078,599) | (30,447,605) | |
Provision for income taxes | (800) | (800) | |
Loss from continuing operations | $ (9,079,399) | $ (30,448,405) | |
Discontinued operations (Note 3) | (3,634,209) | (4,538,027) | |
Net loss | $ (12,713,608) | $ (34,986,432) | |
Basic and diluted loss per share | |||
Continuing operations | $ (0.29) | $ (1.27) | |
Discontinued operations | $ (0.12) | $ (0.19) | |
Total basic and diluted loss per share | $ (0.41) | $ (1.46) | |
Basic and diluted weighted average shares outstanding | 30,947,650 | 24,042,293 | |
SOURCE CytRx Corporation
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