Quarter Marked by Centurion’s Filing of a Provisional Patent for Breakthrough Personalized Medicine Companion Diagnostic to Accompany LADR Assets
Quarter Marked by Centurion’s Filing of a Provisional Patent for Breakthrough Personalized Medicine Companion Diagnostic to Accompany LADR Assets
Improved Finances and Capital Structure Through Expiration of Outstanding Warrants and Extinguishment of Outstanding Debt
Company to Host Conference Call Today at 11:00 am ET (8:00 am PT)
LOS ANGELES, Nov. 2, 2018 /PRNewswire/ -- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced financial results for the quarter ended September 30, 2018, and provided an overview of recent accomplishments and plans for its research and development programs.
“The third quarter of 2018 was highlighted by the filing of a provisional patent by Centurion BioPharma for the breakthrough albumin companion diagnostic (ACDx) for use alongside our innovative LADR™ (Linker Activated Drug Release) assets,” said Eric Curtis, CytRx’s President and Chief Operating Officer. “This new intellectual property is an important component of the overall LADR value proposition and will enhance our efforts to secure a strategic partnership to further advance these unique, promising assets, with the overarching goal of bringing these albumin binding ultra-high potency drug candidates to the physicians and patients who need them.”
“Also during the quarter, we were pleased to make the final payment under our long-term loan agreement, and thereby extinguishing all of our outstanding debt. We also saw the expiration of approximately 3.2 million outstanding warrants for shares of our common stock, improving our overall capital structure.”
Third Quarter 2018 and Recent Highlights
Centurion BioPharma Corporation
- Breakthrough Personalized Medicine Companion Diagnostic Filed for Albumin-Binding LADR™ Drug Candidates. In July 2018, Centurion filed a provisional patent application with the U.S. Patent and Trademark Office covering its unique albumin companion diagnostic (ACDx) for use alongside its albumin binding ultra-high potency LADR™ drug candidates. The goal of ACDx is to identify patients with cancer who are most likely to benefit from the treatment with the Company’s lead assets, LADR-7, LADR-8, LADR-9 and LADR-10 and any albumin-binding drugs the Company may generate in the future.
CytRx Corporation
- Receipt of Milestone Payment from Orphazyme A/S. In September 2018, CytRx announced receipt of a milestone payment totaling $250,000 (USD) from Orphazyme A/S (CPH: ORPHA). The payment was a result of Orphazyme dosing the first patient in their Phase 3 clinical trial evaluating arimoclomol in patients with amyotrophic lateral sclerosis. Orphazyme, a public company trading on the Nasdaq Copenhagen exchange, is testing arimoclomol in three additional indications beyond ALS, including Niemann-Pick disease Type C, Gaucher disease and sporadic Inclusion Body Myositis. Should arimoclomol be approved for NPC in Europe, CytRx will receive a $4 million milestone payment, plus royalties. Additional arimoclomol milestones include $6 million upon approval in the U.S. and $2 million upon approval in Japan, plus royalties on net sales in all territories.
- Paid Off Long-Term Loan. In August 2018, CytRx announced that it made the final payment under a long-term loan agreement. As of August 1, 2018, the loan was paid in full, which extinguished all of CytRx’s outstanding debt.
- Expiration of the Majority of Outstanding Warrants. In July 2018, CytRx announced the expiration of warrants for approximately 3.2 million shares of its common stock. CytRx believes the expiration of these warrants, the majority of which were associated with a public offering in December 2016, eliminates overhang and provides additional common share float stability.
- Participated in Three Institutional Investor Conferences. During the third quarter, CytRx participated in three institutional investor conferences in New York City, including the H.C. Wainwright & Co. 20th Annual Global Investment Conference, the 2018 MicroCap Conference and the Singular Research Summer Solstice 2018 Conference. At each conference, CytRx executive management made a formal presentation and had one-on-one meetings with institutional investors.
Third Quarter 2018 Financial Results
CytRx reported cash and cash equivalents of $24.7 million as of September 30, 2018.
Net loss for the quarter ended September 30, 2018, was $3.3 million, or $(0.10) per share, compared with a net loss of $5.1 million, or $(0.19) per share, for the comparative 2017 period, a reduction of $1.8 million, or approximately 36 percent. The comparative 2017 quarter included a non-cash gain of $3.8 million on the fair value adjustment of warrant derivative liabilities related to warrants issued in 2016, compared to no gain during the current third quarter related to these now expired warrants.
Research and development (R&D) expenses were $0.9 million for the third quarter of 2018, which represents primarily expenses for the development of the albumin companion diagnostic (ACDx). In the third quarter of 2017, R&D expenses of $4.8 million included $3.7 million related to our aldoxorubicin program and its clinical support and $1.0 million for pre-clinical development of new albumin-binding, ultra-high potency cancer drugs.
General and administrative (G&A) expenses were $2.4 million for the third quarter of 2018, compared with $3.4 million for the third quarter of 2017. G&A expenses decreased by approximately 31 percent primarily due to a decrease in professional fees.
Based on our currently projected expenditures for the next 13 months our monthly burn rate is estimated at approximately $700,000 per month.
Conference Call and Webcast
CytRx will be hosting a conference call and webcast today beginning at 11:00 am Eastern Time (8:00 am Pacific Time). To access the conference call, dial (+1) 844-358-6753 (U.S. and Canada) or (+1) 216-562-0397 (international callers) and enter the conference ID number: 4382473. A live and archived webcast will be available in the News and Events/Events Calendar section of the Company’s website, www.cytrx.com. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial (+1) 855-859-2056 (U.S. and Canada) or (+1) 404-537-3406 (international callers) and enter the conference ID number: 4382473.
About CytRx Corporation
CytRx Corporation (NASDAQ: 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. CytRx Corporation’s website is www.cytrx.com.
About Centurion BioPharma Corporation
CytRx’s wholly owned subsidiary, Centurion BioPharma Corporation, is focused on the development of personalized medicine that will 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 continued use and growth of immunotherapy drugs by Big Pharma; the ability of NantCell, Inc., to obtain regulatory approval for its products that use aldoxorubicin; the ability of NantCell, 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 NantCell, Inc.; risks and uncertainties relating to the ability of Orphazyme A/S to obtain regulatory approval for its products that use arimoclomol; the ability of Orphazyme A/S to manufacture and commercialize products or therapies that use arimoclomol; the amount, if any, of future milestone and royalty payments that we may receive from Orphazyme A/S; 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.
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
cytrx@argotpartners.com
| CYTRX CORPORATION | |||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||
| (Unaudited) | |||
| September 30, 2018 | December 31, 2017 | ||
| ASSETS | |||
| Current assets: | |||
| Cash and cash equivalents | $ 24,668,339 | $ 37,643,404 | |
| Receivables | 5,981,040 | 7,529,032 | |
| Prepaid expenses and other current assets | 1,252,186 | 1,914,077 | |
| Total current assets | 31,901,565 | 47,086,513 | |
| Equipment and furnishings, net | 646,500 | 1,042,892 | |
| Goodwill | 183,780 | 183,780 | |
| Other assets | 34,334 | 34,334 | |
| Total assets | $ 32,766,179 | $ 48,347,519 | |
| LIABILITIES AND STOCKHOLDERS’ | |||
| Current liabilities: | $ 2,900,758 | $ 4,122,017 | |
| Accrued expenses and other current liabilities | 7,515,258 | 8,029,274 | |
| Deferred revenue | — | 6,924,353 | |
| Warrant liabilities | — | 527,025 | |
| Term loan, net | — | 10,599,795 | |
| Total liabilities | 10,416,016 | 30,202,464 | |
| Commitments 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 | — | — | |
| Preferred Stock, $1,000 stated value, 650 shares authorized, no shares issued and outstanding | — | — | |
| Common stock, $0.001 par value, 41,666,667 shares authorized; 33,637,501 shares issued and outstanding at September 30, 2018; 28,037,501 shares issued and outstanding at December 31, 2017 | 33,637 | 28,037 | |
| Additional paid-in capital | 476,843,206 | 468,969,445 | |
| Accumulated deficit | (454,526,680) | (450,852,427) | |
| Total stockholders’ equity | 22,350,163 | 18,145,055 | |
| Total liabilities and stockholders’ equity | $ 32,766,179 | $ 48,347,519 | |
| CYTRX CORPORATION | |||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
| (Unaudited) | |||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
| 2018 | 2017 | 2018 | 2017 | ||||
| Revenue: | |||||||
| Licensing revenue | $ 250,000 | $ — | $ 250,000 | $ — | |||
| Expenses: | |||||||
| Research and development | 909,712 | 4,755,191 | 3,186,839 | 17,675,079 | |||
| General and administrative | 2,360,996 | 3,418,808 | 6,514,107 | 9,534,872 | |||
| 3,270,708 | 8,173,999 | 9,700,946 | 27,209,951 | ||||
| Loss before other income | (3,020,708) | (8,173,999) | (9,450,946) | (27,209,951) | |||
| Other income (loss): | |||||||
| Interest income | 93,391 | 119,900 | 269,299 | 271,292 | |||
| Interest expense | (363,086) | (828,120) | (1,715,733) | (2,999,230) | |||
| Other (loss), net | (641) | (6,055) | (5,848) | (16,722) | |||
| Gain (loss) on warrant derivative liabilities | — | 3,763,855 | 527,025 | (572,209) | |||
| Net loss | $ (3,291,044) | $ (5,124,419) | $ (10,376,203) | $ (30,526,820) | |||
| Basic and diluted net loss per share | $ (0.10) | $ (0.19) | $ (0.34) | $ (1.33) | |||
| Basic and diluted weighted-average shares outstanding | 32,991,506 | 26,618,098 | 30,242,788 | 22,936,843 | |||
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SOURCE CytRx Corporation
Company Codes: NASDAQ-SMALL:CYTR
