- July – reported highly favorable data from a human model of glioblastoma implanted in animals and treated with aldoxorubicin, including statistically significant efficacy and prolonged survival.
- September – announced preliminary data from the global Phase 2b soft tissue sarcoma trial showing patients treated with aldoxorubicin had an Overall Response Rate (ORR) of 22%, whereas those administered the widely used chemotherapeutic agent doxorubicin had an ORR of 0%.
- 4Q13 – initiate a Phase 2 trial with aldoxorubicin in patients with relapsed glioblastoma. Study site participants include The John Wayne Cancer Center in Santa Monica, Calif., the City of Hope in Duarte, Calif. and the LSU Health Science Center in New Orleans.
- 4Q13 – initiate a Phase 2 trial evaluating the preliminary efficacy of aldoxorubicin in treating AIDS-related Kaposi’s sarcoma; this trial will enroll up to 30 patients at the LSU Health Science Center.
- December 2013 – report top-line progression-free survival results from the global Phase 2b trial comparing the efficacy and safety of aldoxorubicin and doxorubicin as a first-line treatment for patients with soft tissue sarcoma.
- 1Q14 – initiate a global Phase 3 pivotal trial with aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma who have failed chemotherapy under a special protocol assessment.
- Ongoing – work to expand the oncology pipeline by combining our novel linker platform technology with additional chemotherapeutic agents.
General and administrative (G&A) expenses were $2.0 million for the third quarter of 2013, compared with $1.7 million for the comparable period in 2012.CytRx reported cash, cash equivalents and short-term investments of $23.0 million and no debt as of September 30, 2013. Subsequent to the close of the quarter, on October 15, 2013 the Company completed an underwritten public offering of common stock, raising net proceeds of approximately $24.1 million. About Soft Tissue Sarcoma Sarcoma is an umbrella term for more than 50 subtypes of cancer that occur in the muscles, fat, blood vessels, tendons and other connective tissues in the body. Last year an estimated 38,000 new cases of soft tissue sarcoma were reported and more than 13,000 deaths were attributed to this cancer in the U.S. and Europe. Patients with metastatic, locally advanced or unresectable soft tissue sarcomas have a poor prognosis with progression-free survival of around 2 months to 4.6 months and median overall survival of approximately 9 months to 12 months. CytRx has been granted orphan drug designation by the FDA for the treatment of patients with soft tissue sarcomas. About Glioblastoma Glioblastoma is the most common and most malignant brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. Despite surgical resection, radiotherapy and chemotherapy, the median survival after diagnosis is approximately 12 months to 14 months. Although the reason for treatment failure may depend upon several factors, limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood-brain barrier. About Aldoxorubicin The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 500 mg/m 2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2 g/m 2. About CytRx Corporation CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx is conducting a global Phase 2b trial with aldoxorubicin as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 trial primarily in the same indication and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and has completed a Phase 1b pharmacokinetics trial in patients with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a potential pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx also is initiating Phase 2 trials with aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and AIDS-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. 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 relating to the outcome, timing and results of CytRx's clinical trials, the risk that any future human testing of aldoxorubicin, including the conclusion of the global Phase 2b trial testing of aldoxorubicin as a first-line treatment in patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy, might not produce objective response results similar to the preliminary data described in this press release, or might not correlate with the trial’s primary endpoint of progression-free survival, risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, and the 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.
|CONDENSED BALANCE SHEETS|
|September 30, 2013||December 31, 2012|
|Cash and cash equivalents||$||6,036,220||$||14,344,088|
|Prepaid expenses and other current assets||875,093||1,212,041|
|Total current assets||23,991,724||39,692,448|
|Equipment and furnishings, net||188,235||253,277|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other current liabilities||3,314,859||3,033,189|
|Total current liabilities||13,325,029||10,065,935|
|Commitments and contingencies|
|Preferred Stock, $0.01 par value, 5,000,000 shares authorized, including 25,000 shares of Series A Junior Participating Preferred Stock; no shares issued and outstanding||—||—|
|Common stock, $0.001 par value, 250,000,000 shares authorized; 30,608,392 shares issued and outstanding at September 30, 2013; 30,607,916 shares issued and outstanding at December 31, 2012||30,609||30,608|
|Additional paid-in capital||262,656,237||261,318,638|
|Treasury stock, at cost (132,980 shares at September 30, 2013 and 90,546 shares at December 31, 2012)||(2,373,442||)||(2,279,238||)|
|Total stockholders’ equity||11,141,981||30,165,841|
|Total liabilities and stockholders’ equity||$||24,467,010||$||40,231,776|
|CONDENSED STATEMENTS OF OPERATIONS|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||4,013,572||3,157,656||11,828,575||10,245,637|
|General and administrative||1,987,512||1,729,893||5,775,767||5,736,464|
|Loss before other income (loss)||(6,001,084||)||(4,887,549||)||(17,404,342||)||(15,982,101||)|
|Other income (loss):|
|Other income, net||822||10,370||202,520||60,921|
|Gain (loss) on warrant derivative liabilities||(4,010,811||)||6,436,342||(3,172,324||)||(5,980,016||)|
|Net income (loss)||$||(9,980,005||)||$||1,584,197||$||(20,267,256||)||$||(21,813,157||)|
|Basic net income (loss) per share||$||(0.33||)||$||0.07||$||(0.67||)||$||(1.03||)|
|Basic weighted-average shares outstanding||30,443,293||21,208,660||30,426,460||21,208,960|
|Diluted net income (loss) per share||$||(0.33||)||$||0.07||$||(0.67||)||$||(1.03||)|
|Diluted weighted-average shares outstanding||30,443,293||21,724,986||30,426,460||21,208,960|