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Inovio Pharmaceuticals Reports 2016 Third Quarter Financial Results

On November 9, 2016 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported financial results for the quarter ended September 30, 2016 (Press release, Inovio, NOV 9, 2016, View Source [SID1234516542]). The following financial results provide a year-over-year comparison of the third quarter in 2016 and 2015. Total revenue was $12.5 million compared to $24.2 million. Total operating expenses were $32.7 million compared to $20.5 million. The net loss attributable to common stockholders was $20.8 million, or $0.28 per share for the third quarter 2016, compared to net income of $5.6 million, or $0.08 per share in the third quarter of 2015.

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Revenue

The decrease in revenue for the comparable periods was primarily due to $15.0 million of revenue recognized in the third quarter 2015 from the up-front payment received from our partnership agreement with MedImmune. Accounting recognition of the remainder of the $27.5 million upfront payment was deferred and will be triggered by future events. The net income achieved during the third quarter 2015 was attributable to the increase in revenue and may not repeat in future quarters.

Operating Expenses

Research and development expenses were $27.0 million compared to $16.1 million for the third quarter ending 2016 and 2015 respectively. The increase was primarily related to increased investment in our product development programs – notably the DARPA funded Ebola program and clinical trial preparations for the initiation of the VGX-3100 phase III study. General and administrative expenses were $5.8 million compared to $4.4 million.

Capital Resources

As of September 30, 2016, cash and cash equivalents and short-term investments were $119.7 million compared with $163.0 million as of December 31, 2015. There were 74.0 million shares outstanding and 81.8 million fully diluted.

During the three months ended September 30, 2016, the Company sold 448,848 shares of common stock under its ATM common stock sales agreement for net proceeds of $4.2 million, with an average price of $9.45 per share.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q providing the complete 2016 Third quarter financial report can be found at: View Source

Corporate Update

Clinical Development

The U.S. Food and Drug Administration (FDA) requested additional information regarding Inovio’s submission for its proposed phase III clinical program for VGX-3100, placing the program on clinical hold. The study had not yet been initiated and has not enrolled or dosed subjects. In its initial communication the FDA requested additional data to support Inovio’s shelf-life claim for the single-use disposable array of the newly designed and manufactured CELLECTRA 5PSP immunotherapy delivery device. Inovio expects to receive a formal letter in November, which may request other information, and estimates the start of the phase III clinical program will be delayed until the first half of 2017, pending resolution of the FDA’s request. This clinical hold does not affect other Inovio clinical programs.
Initiated a phase I Zika DNA vaccine trial in Puerto Rico to test for safety, immune responses and initial evidence of efficacy. The placebo-controlled double-blind trial will assess differences in Zika infection rates in 160 healthy participants given either placebo or vaccine as part of an exploratory endpoint. This is the second human Zika vaccine trial initiated by Inovio. All 40 subjects for the first clinical study have been fully enrolled and dosed.
Expanded phase I Ebola vaccine trial by fully enrolling an additional 125 subjects in a second stage after generating positive initial safety and immune response data in the first set of 75 healthy volunteers. The study will assess immune response characteristics generated with fewer intradermal administrations, lower doses, and with and without its DNA-based IL-12 immune activator.
Corporate Development

Inovio incorporated a 100%-owned subsidiary, GENEOS Therapeutics, Inc., to develop and commercialize neo-antigen based personalized cancer therapies. While Inovio pursues the unique potential of its SynCon immunotherapy design to break tolerance and create cancer products targeting universal tumor specific antigens, GENEOS will exclusively focus on leveraging Inovio’s potent DNA immunotherapy technology platform to advance the emerging field of patient-specific neo-antigen therapies. Inovio’s clinically validated DNA based platform is well suited for advancing individualized therapies due to its rapid product design and manufacturing benefits, ability to combine multiple neo-antigens into formulations, and generation of potent killer T cell responses that are needed to drive clinical efficacy. GENEOS plans to independently raise capital and build a team to execute this complementary business model. Inovio will continue its focus on advancing its universal antigen-specific cancer immunotherapy portfolio, including INO-3112 (with Medimmune), INO-5150, INO-1400, and INO-5401, as well as its pre-cancer (VGX-3100) and infectious disease products.
Licensed a veterinary vaccine for foot and mouth disease (FMD) to Plumbline Life Sciences, an animal health company headquartered in South Korea. Plumbline will fund all development activities for this FMD vaccine and pay Inovio milestone payments as well as royalties on potential product sales.
Inovio expanded its leadership team with the appointment of multiple individuals to lead the functions of business development, biologic and device manufacturing, regulatory, and oncology clinical development.

BioSpecifics Technologies Corp. Reports Third Quarter 2016 Financial Results

On November 9, 2016 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase based-therapies with a first in class collagenase-based product collagenase clostridium histolyticum, or CCH, marketed as XIAFLEX in the U.S. and Xiapex in Europe reported its financial results for the third quarter ended September 30, 2016 and provided a corporate update (Press release, BioSpecifics Technologies, NOV 9, 2016, View Source [SID1234516537]).

"BioSpecifics concentrates on developing XIAFLEX for medically necessary indications, and we look forward to the initiation of our Phase 1 clinical trial for the treatment of uterine fibroids by the end of this year," said Thomas L. Wegman, President of BioSpecifics. "Our partner Endo continues to see XIAFLEX as a core U.S. branded product and growth driver going forward. Cellulite is their main focus for non-marketed indications and they plan to announce Phase 2b data upon the completion of that trial. Endo is conducting a full commercial assessment and analysis of the R&D pipeline which will determine the clinical trial timelines moving forward."

Third Quarter 2016 Financial Results
BioSpecifics reported net income of $3.1 million for the third quarter ended September 30, 2016, or $0.43 per basic share and $0.42 per share on a fully diluted basis, compared to net income of $2.9 million, or $0.42 per basic share and $0.39 per share on a fully diluted basis, for the same period in 2015.

Total revenue for the third quarter ended September 30, 2016 was $6.9 million, compared to $6.3 million for the same period in 2015. The increase in total revenue was due to increased royalties received and licensing fees related to the exercise of an opt-in right by Endo International plc (Endo) for the human lipoma indication.

Royalty and mark-up on cost of goods sold (COGS) revenues recognized under BioSpecifics’ agreement with Endo for the third quarter ended September 30, 2016 were $6.1 million, compared to $5.3 million for the same period in 2015, an increase of $0.8 million, or 15 percent. This increase in royalties and the mark-up on cost of goods sold was primarily due to the increase in sales of XIAFLEX for the treatment of Dupuytren’s contracture and Peyronie’s disease.

Licensing revenue consists of licensing fees, sublicensing fees and milestones. BioSpecifics recognized licensing fees related to the exercise of an opt-in right by Endo for the human lipoma indication of $750,000 for the three months ended September 30, 2016 as compared to zero in the corresponding 2015 period. In addition, the Company recognized certain licensing fees related to the cash payments received under the agreement with Endo in prior years and amortized them over the expected development period. For each of the three month periods ended September 30, 2016 and 2015, the Company recognized licensing revenue related to the development of injectable collagenase of approximately $12,000.

Milestone revenue recognized for the three months ended September 30, 2016 was zero as compared to $1.0 million for the corresponding 2015 period. The $1.0 million milestone revenue recognized in the corresponding 2015 period related to the first commercial sale of XIAFLEX by Asahi Kasei Pharma Corporation for the treatment of Dupuytren’s contracture in Japan.
Research and development (R&D) expenses for each of the third quarters ended September 30, 2016 and 2015 were $0.3 million.
General and administrative expenses for the third quarter ended September 30, 2016 were $1.8 million, compared to $1.7 million for the same period in 2015.

Provision for income taxes for the third quarter ended September 30, 2016 were $1.8 million, compared to $1.5 million for the same period in 2015.

As of September 30, 2016, BioSpecifics had cash and cash equivalents and investments of $51.3 million, compared to $37.1 million as of December 31, 2015.

XIAFLEX U.S. Commercial Highlights
On November 8, 2016, Endo reported U.S. commercial highlights for XIAFLEX for the third quarter of 2016 (Endo’s third quarter 2016 financials are reported in BioSpecifics’ fourth quarter 2016 financials). For the third quarter of 2016, U.S. net sales were $47.7 million, an increase of 19 percent compared to the third quarter of 2015.

CCH Pipeline Updates and Anticipated Upcoming Milestones
BioSpecifics manages the development of collagenase clostridium histolyticum (CCH) for uterine fibroids, and initiates the development of CCH in new potential indications, not licensed by Endo. In addition to Dupuytren’s contracture and Peyronie’s disease, Endo’s licensed rights include human and canine lipoma, adhesive capsulitis, cellulite, lateral hip fat and plantar fibromatosis.

BioSpecifics expects to initiate a Phase 1 clinical trial of CCH in uterine fibroids in the fourth quarter of 2016.
Top-line data for the Phase 2b clinical trial of CCH for cellulite will be reported upon the completion of that trial.
Endo has announced that they are conducting a full commercial assessment and analysis for the R&D pipeline to determine the clinical trial timelines moving forward.

BioSpecifics will present a company update at the upcoming Stifel 2016 Healthcare Conference on Tuesday, November 15, 2016 at 8:00 AM E.T. in New York, NY.

Endocyte Reports Third Quarter 2016 Financial Results

On November 9, 2016 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported financial results for the third quarter ending September 30, 2016, and provided a clinical and business update (Press release, Endocyte, NOV 9, 2016, View Source [SID1234516520]).

"Our clinical pipeline made critical progress during the quarter as we have moved both lead SMDC product candidates, EC1456 and EC1169, into the expansion phases of their trials, and confirmed the maximum clinical doses for each," commented Mike Sherman, president and CEO at Endocyte. "We are focused on accelerating progress of both trials to assess the performance of these therapeutic SMDCs along with their companion imaging agents in the targeted indications, and look forward to reporting data on both product candidates at medical conferences in the first half of 2017."

"Key unmet medical needs remain in both prostate cancer and non-small cell lung cancer (NSCLC), which we hope to address with our lead SMDCs. Prostate cancer patients who progress following hormone therapy remain difficult to treat and many NSCLC patients do not respond to immuno-oncology agents and other therapies," commented Alison A. Armour , MD, chief medical officer of Endocyte. "During the EC1169 dose-escalation, we were pleased to see total tumor burden reduction in four out of six patients with measurable disease treated at higher doses, along with our first confirmed RECIST partial tumor response."

EC1169 (PSMA-tubulysin)

Data from the dose escalation phase of the EC1169 trial reported at ESMO (Free ESMO Whitepaper) in October showed that total target tumor burden reduction was observed in 4 of the 6 patients with measurable soft tissue disease treated at doses of 3.8 mg/m2 and higher.
One of these patients demonstrated the first confirmed radiologic partial tumor response (PR) as measured by RECIST 1.1 criteria.
Two patients demonstrated confirmed prostate specific antigen reductions of greater than 50%, one of whom went on to demonstrate the PR.
EC1169 was well tolerated without causing dose-limiting hematologic toxicity frequently associated with traditional chemotherapy. Primary toxicities included fatigue and gastrointestinal (GI) toxicity; predominantly grade 1 and 2, reversible and responsive to simple medication.
The company has confirmed 6.5 mg/m2 once per week, administered 2 weeks out of a 3 week cycle, as the maximum clinical dose and is moving into the expansion phase where 2 cohorts of metastatic castration resistant prostate cancer (mCRPC) patients will be evaluated. One cohort will include patients who previously received a taxane-based therapy and the other cohort will include taxane-naïve patients. Initial patients in this expansion phase have consented to participate and are expected to be treated this month.
EC1456 (Folate-tubulysin)

A dose of 6.0 mg/ m2 was established as the maximum twice per week dose, administered 2 weeks out of a 3 week cycle, which is being used in the expansion phase of the trial where the company will evaluate EC1456 in select folate receptor (FR)-positive NSCLC patients, identified by the companion imaging agent etarfolatide.
Patients included in this phase of the trial will have received first-line chemotherapy and may have also been treated with anti-PD-1 therapy.
EC1456 was well tolerated during dose escalation, with primary toxicities including fatigue, GI toxicity, and electrolyte disturbance; predominantly grade 1 and 2, reversible and responsive to simple medication.
In spite of the inclusion of patients in the dose escalation phase who were not selected as positive for the targeted FR, most patients demonstrated stable disease as best response and several patients demonstrated a reduction in target tumor volume.
Upcoming Expected Milestones for the First Half of 2017

Efficacy and safety data from expansion cohorts for both EC1456 and EC1169 are expected to be reported at medical conferences.
Data from an EC1456 surgical debulking study. This study is designed to assess various metrics related to cell targeting and intratumoral delivery of drug payload.
Data from an EC1169 receptor occupancy study. This study is designed to provide insight into the drug’s interaction with the target receptor.
New pre-clinical data on the CAR-T program are expected to be reported at a scientific conference.
Third Quarter 2016 Financial Results

Endocyte reported a net loss of $8.7 million, or $0.21 per basic and diluted share, for the third quarter of 2016, compared to a net loss of $10.0 million, or $0.24 per basic and diluted share for the same period in 2015.

Research and development expenses were $6.0 million for the third quarter of 2016, compared to $6.6 million for the same period in 2015. The decrease was primarily attributable to a decrease in compensation expense and a decrease in expenses related to the TARGET trial, which is now complete. The net effect of these decreases was partially offset by increases related to the EC1456 and EC1169 dose escalation trials and increases in manufacturing and other research expenses related to EC1456 and EC1169.

General and administrative expenses were $3.0 million for the third quarter of 2016, compared to $3.8 million for the same period in 2015. The decrease was primarily attributable to a decrease in compensation expense and a decrease in expenses related to professional fees and employee benefits.

Cash, cash equivalents and investments were $146.7 million at September 30, 2016, compared to $180.3 million at September 30, 2015, and $173.6 million at December 31, 2015.

Financial Expectations

The company updated its financial expectations and now anticipates its cash balance at the end of 2016 to be above $135 million.

About EC1456 and the Phase 1 Trial

EC1456 is an investigational therapeutic SMDC constructed of a high affinity FR-targeting ligand conjugated through a spacer and bioreleasable linker system to a potent cytotoxic microtubule inhibitor, TubBH. Patient FR-status will be determined using the investigational companion imaging agent, etarfolatide. EC1456 and etarfolatide are currently being evaluated in a phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT01999738).

The open-label, multicenter, non-randomized, study is divided into two parts. The first part of the study was designed to determine the maximum clinical dose and recommended Phase 2 dose of EC1456 in patients with metastatic or locally advanced solid tumors.

Endocyte has now initiated the expansion phase of the study which is designed to evaluate the efficacy of EC1456 in patients with NSCLC known to express the FR and treated with the maximum clinical dose of EC1456. The twice weekly (BIW) dosing schedule at a 6.0 mg/m2 dose will be evaluated and then upon completion of this dosing schedule, additional patients will be enrolled in a once per week dosing schedule cohort. Single agent anti-tumor response will be evaluated, which will inform and may trigger additional work in combination therapies and indications such as triple-negative breast cancer, ovarian cancer and endometrial cancer.

About EC1169 and the Phase 1 Trial

EC1169 is an investigational therapeutic SMDC constructed of a high affinity prostate specific membrane antigen (PSMA)-targeting ligand conjugated through a bioreleasable linker system to a potent microtubule inhibitor, tubulysin B hydrazide (TubBH). Patient PSMA-status will be determined using the investigational companion imaging agent, EC0652. EC1169 and EC0652 are currently being evaluated in a phase 1 study in patients with mCRPC (ClinicalTrials.gov Identifier: NCT02202447).

The open-label, multicenter, non-randomized, study is divided into two parts. The first part of the study, now complete, was designed to determine the maximum clinical dose and recommended Phase 2 dose of EC1169 in patients with prostate cancer.

Endocyte has now initiated the second part of the study which is designed to evaluate the efficacy of EC1169 in taxane-exposed and taxane-naïve mCRPC, with a primary study endpoint of radiographic progression free survival in patients selected as PSMA-positive.

Eagle Pharmaceuticals, Inc. Reports Third Quarter 2016 Results

On November 9, 2016 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three- and nine-months ended September 30, 2016 (Press release, Eagle Pharmaceuticals, NOV 9, 2016, View Source [SID1234516517]). Highlights of and subsequent to the third quarter of 2016 include:

Business Highlights:

Bendeka total market share rose to 88%, as of November 6, 2016;
The Centers for Medicare & Medicaid Services (CMS) established a unique J-Code (J9034) for Bendeka effective January 1, 2017;
Positive initial results of animal study exploring use of Ryanodex in MDMA (Ecstasy) induced hyperthermia conducted at the National Institutes of Health (NIH);
Extended our licensing agreement with Teva Pharmaceutical Industries Ltd. (Teva) to include certain territories outside the US and Canada; and
Repurchased $18.0 million of Eagle common stock during the third quarter for a total of $32.0 million since commencing the Share Repurchase Program on August 9, 2016.
Financial Highlights:

Total revenue was $37.8 million during the third quarter of 2016 compared to $5.7 million for the three months ended September 30, 2015;
Product sales increased to $7.8 million during the third quarter of 2016 compared to $3.3 million for the prior year period;
Royalty income increased to $26.2 million during the third quarter of 2016 compared to $2.4 million for the prior year period;
License and other income was $3.8 million during the third quarter of 2016;
Sales of Ryanodex grew 92% to $2.5 million during the third quarter of 2016 compared to $1.3 million for the prior year period;
Net income was $12.0 million, or $0.77 per basic and $0.73 per diluted share, compared to a net loss of $10.2 million, or $(0.65) per basic and diluted share, for the three months ended September 30, 2016 and 2015, respectively; and,
Cash and cash equivalents were $59.3 million and accounts receivable were $47.1 million as of September 30, 2016.
"We had another strong quarter delivering results for our shareholders, reflecting our ability to execute Eagle’s strategy to develop and commercialize improved formulations that enhance patients’ lives. Bendeka market share continues to ramp up and is approaching our joint goal with Teva of 90%. We believe the CMS final ruling to establish a unique J-Code for Bendeka will not only aid further adoption, but also provide greater access for patients and facilitate reimbursement. We remain confident in our ability to drive continued growth in our bendamustine franchise well beyond 2019," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"We are also particularly excited about the multiple opportunities within our pipeline to drive substantial value beyond 2020. We are very encouraged by early results of clinical testing to explore the potential of Ryanodex for the treatment of both exertional heat stroke and MDMA (Ecstasy) induced hyperthermia. If approved, both indications would address the needs of very significant new patient populations for whom no pharmaceutical treatment options are currently available. Our development work on additional product candidates continues, providing us with a robust pipeline from which to create long term value," added Tarriff.

"We remain focused on optimizing the deployment of our capital on behalf of shareholders and continue to evaluate opportunities to do so. As part of that effort, since August 9, we purchased a total of $32 million through our stock buyback program and are pleased with our solid financial position," concluded Tarriff.

Third Quarter 2016 Financial Results

Total revenue for the three months ended September 30, 2016 was $37.8 million, as compared to $5.7 million for the three months ended September 30, 2015. A summary of total revenue is outlined below:

Three Months Ended
September 30,

Increase
2016 2015
(in thousands)
Product sales $ 7,837 $ 3,314 $ 4,523
Royalty income 26,246 2,422 23,824
License and other income 3,750 3,750
Total revenue $ 37,833 $ 5,736 $ 32,097

Product sales increased $4.5 million to $7.8 million driven by due to increases in Bendeka, Non-Alcohol Docetaxel Injection, Argatroban, and Ryanodex net product sales of Ryanodex, offset by a decrease in net product sales of diclofenac-misoprostol. Royalty income increased $23.8 million to $26.2 million, as a result of the launch of Bendeka in January 2016.

Cost of revenue increased by $6.7 million to $10.4 million in the three months ended September 30, 2016 from $3.8 million in the three months ended September 30, 2015. This $6.7 million net increase resulted from $0.8 million in cost of revenue for Non-Alcohol Docetaxel Injection, an increase of $0.8 million in the cost of Argatroban, and an increase of $5.3 million related to the cost of Bendeka product sales: $2.4 million of product sales, $2.4 million of royalties and $0.5 million of other expense, and a decrease of $0.2 million in cost of revenue for Ryanodex.

Research and development expenses decreased by $3.7 million to $3.2 million in the three months ended September 30, 2016, compared to $6.9 million in the prior year quarter. The decrease resulted from certain cost reimbursements from one of our suppliers, non-recurrence of project spending for Ryanodex (dantrolene sodium) for exertional heatstroke related to the completion of the clinical treatment portion of the safety and efficacy study, and lower project spending for pemetrexed, offset by the increase in project spending for bivalirudin, and other projects, and higher salary and other personnel-related expenses due to increased headcount.

SG&A expenses increased $6.4 million to $11.9 million in the third quarter of 2016 compared to $5.5 million in the three months ended September 30, 2015. Personnel-related expenses accounted for the bulk of the $6.4 million increase and were due to overall expansion of the business.

Net income for the third quarter was $12.0 million, or $0.77 per basic share and $0.73 per diluted share, compared to a net loss of $10.2 million, or ($0.65) per basic and diluted share in the three months ended September 30, 2015, as a result of the factors discussed above.

Liquidity

As of September 30, 2016, the Company had $59.3 million in cash and cash equivalents; $47.1 million in receivables, with approximately $30.9 million due from Teva; and no debt.

Events Subsequent to the End of the Third Quarter

The Centers for Medicare & Medicaid Services (CMS) established a unique, product-specific billing code, or J-code (J9034), for Bendeka (bendamustine hydrochloride) Injection. The J-code will become effective on January 1, 2017.

The new J-code provides reimbursement coding clarity to outpatient facilities and physicians that administer Bendeka, facilitating access for patients and Medicare, Medicaid and commercial insurance reimbursement.

The J-Code decision triggered a $40 million milestone payment from Teva and an increase in Eagle’s royalty from 20% to 25% of net sales of Bendeka.

CytRx Reports Third Quarter 2016 Financial Results

On November 9, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the three months ended September 30, 2016, and provided an overview of recent corporate developments and upcoming milestones for its research and development programs (Press release, CytRx, NOV 9, 2016, View Source;p=RssLanding&cat=news&id=2220972 [SID1234516514]).

"This month we expect to report additional data from our pivotal, global Phase 3 clinical trial of aldoxorubicin in patients with second-line soft tissue sarcomas (STS)," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "We then plan to schedule a pre-NDA meeting with the FDA. Additionally, we recently completed enrollment in the aldoxorubicin Phase 2b clinical trial in second-line small cell lung cancer in September. We now estimate that top-line results will be available in the first half of 2017 as the number of progression events has not yet been reached."

Third Quarter 2016 and Recent Developments

Presented Positive Aldoxorubicin Combination Clinical Trial Results at ESMO (Free ESMO Whitepaper) 2016. On October 10, 2016, CytRx presented a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress featuring interim clinical data from its on-going clinical trial of aldoxorubicin in combination with ifosfamide and mesna in patients with soft tissue sarcomas. Of 36 evaluable patients, 13 of 36 (36%) achieved a partial response of the target lesion by RECIST 1.1 criteria, 22 of 36 (61%) had stable disease, and one patient had progressive disease. Median progression-free survival has not yet been reached. While the combination did have certain toxicities, none were treatment-limiting.

Completed enrollment in its Global Phase 2b Clinical Trial in Second-Line Small Cell Lung Cancer. On September 6, 2016, CytRx announced that it completed enrollment in its global, randomized Phase 2b clinical trial comparing aldoxorubicin to topotecan in 135 patients with small cell lung cancer (SCLC) who have progressed or relapsed to prior chemotherapy. The primary endpoint is progression-free survival. The number of progression events has not yet been reached, and CytRx currently expects to announce top-line data in the first half of 2017.

Strengthened the Balance Sheet with an Equity Financing. On July 20, 2016, CytRx completed a public offering of common stock and one-year warrants for total net proceeds of aproximately $18.3 million. If exercised in full, the warrants would provide up to an additional $20 million in capital.

Reported Initial Analysis of its Pivotal, Global Phase 3 Aldoxorubicin Trial in STS. On July 11, 2016, CytRx reported interim results from its global, randomized, Phase 3 clinical trial of aldoxorubicin compared to investigator’s choice therapy in patients with relapsed or refractory STS. The Company also previously announced that it expects to report additional data from the trial in the fourth quarter. Following the subsequent analysis, CytRx plans to schedule a pre-NDA meeting with the FDA to seek marketing approval. In addition, patients in the Phase 3 clinical trial continue to be followed for overall survival, a secondary endpoint of the trial.

Capital Conservation. During the third quarter, CytRx embarked on a plan to reduce spending until additional results from the aldoxorubicin Phase 3 STS clinical trial are available and the Company meets with the FDA. This included reducing headcount, stopping pre-commercialization activities for aldoxorubicin and suspending further development of DK049.

Pipeline Generation Activities. CytRx’s expanded its drug discovery efforts to create a pipeline of oncology candidates utilizing the Company’s LADRTM technology to attach ultra-high potency drugs to albumin (10-1000 times more potent than traditional chemotherapies limited to antibodies only) to target tumors.

Upcoming Milestones

Present interim data from the on-going Phase 1b/2 clinical trial of aldoxorubicin in combination with ifosfamide/mesna at the Connective Tissue Oncology Society (CTOS) Annual Meeting being held on November 9-12, 2016, in Lisbon, Portugal.
Announce additional data from CytRx’s pivotal, global Phase 3 clinical trial of aldoxorubicin in patients with second-line STS in November 2016.
Report top-line results from the global Phase 2b clinical trial evaluating aldoxorubicin versus topotecan in patients with second-line SCLC in the first half of 2017.
Schedule and hold a pre-NDA meeting with the FDA regarding aldoxorubicin as a treatment for patients with relapsed or refractory advanced STS.
Third Quarter 2016 Financial Results

CytRx reported cash and cash equivalents of $58.9 million as of September 30, 2016.

Net loss for the quarter ended September 30, 2016 was $12.2 million, or $0.13 per share, compared with a net loss of $7.1 million, or $0.11 per share, for the quarter ended September 30, 2015. During the third quarter of 2016, CytRx recognized a non-cash gain on warrant derivative liability of $0.2 million, compared to a non-cash gain of $3.5 million for the three-month period ended September 30, 2015.

Research and development (R&D) expenses were $8.9 million for the third quarter of 2016, and included development expenses of $6.7 million for the aldoxorubicin program. R&D expenses were $8.5 million for the third quarter of 2015.

General and administrative (G&A) expenses were $2.8 million for the third quarter of 2016, compared to $2.2 million for the third quarter of 2015. G&A expenses for the third quarter 2016 included non-cash employee stock-compensation expense of $0.6 million, compared to $0.5 million for the same period in 2015.