On May 10, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported financial results for the quarter ended March 31, 2017 (Press release, Inovio, MAY 10, 2017, View Source [SID1234519033]).

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Total revenue was $10.4 million for the three months ended March 31, 2017, compared to $8.1 million for the same period in 2016. Total operating expenses were $32.3 million compared to $23.6 million.

The net loss attributable to common stockholders for the quarter ended March 31, 2017, was $23.1 million, or $0.31 per share, compared to $8.0 million, or $0.11 per share, for the quarter ended March 31, 2016. The increase in net loss for the quarter resulted primarily from a higher non-cash accounting expense related to the change in fair value of the investment in our affiliated entity.

Revenue

The increase in revenue was primarily due to the revenue recognized from the termination payment received from Roche during Q1 2017.

Operating Expenses

Research and development expenses for Q1 2017 were $24.5 million compared to $18.2 million for Q1 2016. The increase in R&D expenses was related to increased investment in all our product development programs. General and administrative expenses were $7.8 million for Q1 2017 versus $5.4 million for Q1 2016. The increase in G&A expenses primarily related to an increase in non-cash stock based compensation.

Capital Resources

As of March 31, 2017, cash and cash equivalents and short-term investments were $89.7 million compared with $104.8 million as of December 31, 2016. At quarter end the company had 74.6 million shares outstanding and 84.1 million fully diluted.

Under a collaboration and license agreement established with ApolloBio Corporation in February, Inovio expects to receive up to $50 million in payments and an equity investment. Details of this agreement are discussed under Corporate Development below.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q providing the complete 2017 first quarter financial report can be found at: View Source

Corporate Update

Clinical Development

VGX-3100: Cervical Pre-Cancer (Phase 3)

Subsequent to the quarter, Inovio submitted a complete response relating to the clinical hold imposed by the U.S. FDA regarding device-related questions and comments pertaining to its VGX-3100 phase 3 program. Inovio’s new CELLECTRA 5PSP commercial delivery device has been the focus of a clinical hold since 4Q 2016. The FDA’s information request sought to confirm details on various parameters of this new fully automated device developed for the phase 3 clinical study and future commercial use. Inovio’s response involved the generation of extensive testing and validation data. If this complete response is deemed satisfactory by the FDA to lift the clinical hold, Inovio would be in a position to start the phase 3 study in the second quarter.
We have been preparing investigational sites for the phase 3 study and are prepared to enroll patients after the clinical hold is lifted and the study is initiated.
VGX-3100: Vulvar Pre-Cancer (Phase 2)

Subsequent to the quarter, Inovio commenced a randomized, open label phase 2 trial to evaluate the efficacy of VGX-3100 in 36 women with high-grade HPV-related pre-cancerous lesions of the vulva, or vulvar intraepithelial neoplasia, a disease with a high unmet medical need. The immunotherapy will be administered with Inovio’s CELLECTRA intramuscular delivery device. The primary endpoint of the study is histologic clearance of high-grade lesions and virologic clearance of the HPV virus in vulvar tissue samples. The study will also evaluate safety and tolerability.
MEDI0457: HPV-Related Head & Neck Cancer (Phase 1/2)

MedImmune, AstraZeneca’s global biologics research and development arm, will start a combination trial with MEDI0457, an immunotherapy designed to generate antigen specific killer T-cell responses targeting HPV-related tumors, and MedImmune’s recently approved PDL-1 checkpoint inhibitor, durvalumab. MEDI0457, previously known as INO-3112, was developed by Inovio and licensed to MedImmune in 2015. In the second quarter, we expect enrollment to begin of patients with metastatic HPV-related squamous cell carcinoma of the head & neck with persistent or recurrent disease after chemotherapy treatment. The open-label study is designed to evaluate the safety and efficacy of the combination therapy in approximately 50 subjects at multiple U.S. sites. The primary endpoints of the study are safety and tumor regression. The study will also evaluate immunological impact, progression-free survival and overall survival.
Infectious Disease Studies

Completed enrollment of 90 patients in phase 1 study of hepatitis B DNA immunotherapy, INO-1800, and expect to report preliminary immune response data in 2H 2017. The study has completed interim safety reviews with a favorable safety profile.
Reported that in our first 40-subject phase 1 study of GLS-5700 (Zika-001) high levels of binding antibodies were measured in 100% (39 of 39) of evaluated subjects after three doses. The vaccine was safe and well-tolerated. We also expect that our second phase 1 Zika vaccine study of GLS-5700 (ZIKA-002), which is being conducted in Puerto Rico, will fully enroll 160 subjects in 2Q. In this randomized, placebo-controlled, double-blind trial, 80 subjects will receive vaccine and 80 subjects will receive placebo. The study is evaluating the safety, tolerability and immunogenicity of GLS-5700 administered with Inovio’s CELLECTRA-3P intradermal device. The study will also assess differences in Zika infection rates between the arms as an exploratory signal of vaccine efficacy.
Reported that our fully enrolled 75-subject phase 1 study of our MERS DNA vaccine GLS-5300 generated high levels of binding antibodies in 92% (57 of 62) of evaluated subjects after three vaccinations. The vaccine was safe and well-tolerated.
Preliminary results from the expanded stage of our phase 1 study, EBOV-001, demonstrated that 95% (170 of 179) of evaluable subjects generated an Ebola-specific antibody immune response, with the mean antibody titer comparable or superior to those reported from viral vector-based Ebola vaccines; and a favorable safety profile compared to such vaccines.
Corporate Development

Inovio entered into an immuno-oncology collaboration agreement with Regeneron Pharmaceuticals, Inc. Inovio will conduct a phase 1/2 study against newly-diagnosed glioblastoma multiforme (GBM) combining its INO-5401 T-cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12, with Regeneron’s PD-1 checkpoint inhibitor, REGN2810. This 50-subject open-label trial will be conducted at multiple U.S. sites and will evaluate safety, tolerability, immunological impact, tumor regression, progression-free survival and overall survival. Inovio expects to begin enrollment in the second half of the year.
Under a collaboration and license agreement established with ApolloBio Corporation in February, ApolloBio is awaiting approval of the agreement by Chinese regulatory authorities. Upon receiving regulatory approval, ApolloBio will pay Inovio a $3 million signing fee and a $12 million milestone tied to the lifting of the VGX-3100 phase 3 clinical hold by the FDA. Under a separate equity agreement, ApolloBio will invest in Inovio common stock subsequent to lifting of the clinical hold at a volume weighted average price encompassing a trading period prior to and following the lifting of the clinical hold. The aggregate investment, which is expected to be completed in the first half of 2017, will not exceed $35 million and may be a lower amount such that ApolloBio will not be the largest shareholder in Inovio. ApolloBio will fund all clinical development costs within the licensed territory (Greater China), and will pay Inovio up to $20 million based upon the achievement of certain regulatory milestones in the US and China, and tiered double digit royalties on net sales of VGX-3100. The agreements are subject to People’s Republic of China (PRC) corporate and regulatory approvals, and payments are subject to PRC currency approvals.
Inovio academic and industry collaborators received a multi-year $6.95 million grant from the NIH’s National Institute of Allergy and Infectious Diseases to develop a single or combination therapy using Inovio’s PENNVAX-GP and a PD-1 checkpoint inhibitor with the goal of attaining long-term HIV remission in the absence of antiviral drugs.
Inovio’s Board of Directors appointed as a director Mr. George Bickerstaff, an internationally recognized expert in finance, healthcare and information technology. He served Novartis Pharma AG as its chief financial officer and held senior financial positions at IMS Health, Dun & Bradstreet and General Electric. He serves on various boards and is currently partner and managing director of M.M. Dillon & Co., an investment bank and financial advisory firm. Mr. Bickerstaff will stand for election by shareholders with other existing directors at the 2017 annual general meeting.
Preclinical Development

Molecular Therapy published a paper entitled, "A novel DNA vaccine platform enhances neo-antigen-like T-cell responses against WT1 to break tolerance and induce anti-tumor immunity," showing that this DNA-encoded antigen induced T cell responses that caused tumor regression in pre-clinical studies. The WT1 antigen is over-expressed in multiple cancer types but not found in most normal tissue, giving it potential to be used as part of a universal cancer vaccine against multiple tumor types. Inovio has combined WT1 with its hTERT and PSMA antigens, which are also prevalent across many cancer types, to create INO-5401; this new immunotherapy product is advancing into human studies in combination with a Regeneron PD-1 checkpoint inhibitor in patients with GBM.

On May 10, 2017 Immunomedics, Inc., (NASDAQ:IMMU) ("Immunomedics" or "the Company") reported financial results for the third quarter ended March 31, 2017 (Press release, Immunomedics, MAY 10, 2017, View Source [SID1234519032]). The Company also highlighted recent key developments and planned activities for its clinical pipeline.

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"This was clearly a milestone quarter for Immunomedics," stated Behzad Aghazadeh, Chairman of the Board of Immunomedics. "While our financial results were generally in-line with expectations, what is most important is that we have made significant progress towards ensuring that the Company has the financial flexibility to focus on optimizing our organization and bringing IMMU-132, our breakthrough therapy candidate to treat metastatic triple-negative breast cancer, to market on our own. Immunomedics now has a clear strategic plan in place to become a recognized leader in the field of antibody-drug conjugates, which we believe will deliver maximum potential value to all stakeholders."

Third Quarter Fiscal 2017 Results

Total revenues for the third quarter of fiscal 2017, which ended on March 31, 2017, were $1.3 million, compared to $0.9 million for the same quarter for the prior fiscal year, an increase of $0.4 million, or approximately 44%. The increase was due primarily to a $0.4 million increase in LeukoScan product sales.

Total costs and expenses for the quarter ended March 31, 2017 were $23.4 million, compared to $15.5 million for the same quarter in fiscal 2016, an increase of $7.9 million, or approximately 51%, due primarily to a $8.9 million increase in general and administrative expenses, including a $5.9 million increase in legal and advisory fees associated with the proxy contest, professional services in connection with the Licensing Agreement with Seattle Genetics (SGEN) (which was subsequently terminated), a $2.4 million accrual for executive severance compensation, and a $0.6 million increase in other corporate legal fees; offset partially by a $0.8 million decrease in research and development expenses.

The Company recognized a $28.3 million non-cash expense during the three-month period ended March 31, 2017, reflecting the increase in the fair value of warrant liabilities at March 31, 2017 resulting from the increase in price of our common stock during the three-months ended March 31, 2017. The Company also recognized a $7.6 million non-cash expense representing the excess of fair value of the SGEN warrant issued on February 10, 2017 over proceeds received for the issuance of common stock and the warrant. Interest expense related to the 4.75% Convertible Senior Notes due 2020 was $1.4 million for both quarters ended March 31, 2017, and March 31, 2016, including the amortization of $0.2 million debt issuance costs in each quarter.

The Company did not realize any income tax benefit for the quarter ended March 31, 2017, compared to a $1.9 million income tax benefit for the same quarter in fiscal 2016 from the sale of a portion of our New Jersey State tax net operating losses (NOLs) and research and development (R&D) tax credits.

Net loss attributable to stockholders was $59.3 million, or $0.55 per share, for the third quarter of fiscal 2017, compared to net loss attributable to stockholders of $14.0 million, or $0.15 per share, for the same quarter in fiscal 2016, an increase of $45.3 million, or approximately 324%. The increase was due primarily to the $28.3 million increase in the fair value of warrant liabilities, the $8.9 million increase in general and administrative expenses, the $7.6 million SGEN warrant-related expense, and the non-recurring $1.9 million income tax benefit received in fiscal 2016, offset partially by the $0.8 million decrease in research and development expenses.

Nine Months Fiscal 2017 Results

Total revenues for the nine-month period of fiscal 2017 were $2.4 million, compared to $2.3 million for the same period for the prior fiscal year, an increase of $0.1 million, or approximately 4%. The increase was due primarily to a $0.1 million increase in LeukoScan sales.

Total costs and expenses for the nine-month period ended March 31, 2017 were $54.9 million, compared to $46.7 million for the same period in fiscal 2016, an increase of $8.2 million, or approximately 18%, due primarily to a $9.0 million increase in general and administrative expenses, including a $7.0 million increase in legal and advisory fees associated with the proxy contest, professional services in connection with the now-terminated Licensing Agreement with SGEN, a $2.4 million accrual for executive severance compensation, and a $1.4 million increase in legal fees, offset partially by a $1.7 million adjustment for deferred unearned executive bonuses, and a $0.7 million decrease in research and development expenses.

The Company recognized a $35.6 million non-cash expense during the nine-month period ended March 31, 2017, reflecting the increase in the fair value of warrant liabilities from the increase of the common stock price from the issuance dates of February 10, 2017 and October 11, 2016 through March 31, 2017. The Company also recognized a $7.6 million non-cash expense representing the excess of fair value of the SGEN warrant issued on February 10, 2017 over the proceeds received for the issuance of common stock and the warrant. Interest expense related to the 4.75% Convertible Senior Notes due 2020 was $4.1 million for both periods ended March 31, 2017 and March 31, 2016, including the amortization of $0.5 million debt issuance costs in each period.

The Company did not realize any income tax benefit for the nine-month period ended March 31, 2017, compared to a $5.1 million income tax benefit for the same period in fiscal 2016, from the sale of a portion of our New Jersey State tax NOLs or R&D tax credits.

Net loss attributable to stockholders was $100.0 million, or $0.97 per share, for the nine-month period ending March 31, 2017, compared to net loss attributable to stockholders of $43.1 million, or $0.46 per share, for the same period last fiscal year, an increase of $56.9 million, or approximately 132%. The increase was due primarily to the $35.6 million increase in the fair value of warrant liabilities, the $9.0 million increase in general and administrative expenses, the $7.6 million SGEN warrant-related expense, and the non-recurring $5.1 million income tax benefit received in fiscal 2016.

Cash, cash equivalents, and marketable securities were $46.0 million as of March 31, 2017. On May 10, 2017, the Company closed on the previously announced $125 million private placement financing with institutional investors. This financing, along with the Company’s current cash on hand, provides Immunomedics with the capital necessary to fully support the development of IMMU-132, including the goal of filing a Biologics License Application (BLA) with the FDA for Accelerated Approval of IMMU-132 for patients with metastatic triple-negative breast cancer (mTNBC), initiate the Phase 3 confirmatory trial in mTNBC (a prerequisite to filing the BLA), continue large-scale manufacturing of IMMU-132, and begin preparations to market IMMU-132 to mTNBC patients in the United States. It will also be used to fund general corporate and operational enhancements through the third quarter of calendar year 2018, which, the Company believes, is sufficient to attain Accelerated Approval for IMMU-132 in mTNBC subject to meeting all standards, completing review and final determination by the FDA.

"The completion of this financing will give Immunomedics significant financial flexibility," stated Michael R. Garone, Vice President Finance and Chief Financial Officer. "It was highly gratifying to see the enthusiastic response from institutional investors in the market when given the opportunity to invest in the Company. Beyond allowing us to fund the development of IMMU-132, our enhanced capital position will give us the ability to further improve and invest in our organization."

"We are absolutely committed to bring IMMU-132 to the U.S. market ourselves," said Dr. Behzad Aghazadeh, Chairman of the Board of Directors. "Our immediate goals for IMMU-132 are to begin enrolling mTNBC patients in the Phase 3 confirmatory trial during the second half of 2017 and to submit a BLA in mTNBC to the FDA during the late fourth quarter of 2017 or the first quarter of 2018. We are also evaluating strategic opportunities with regional partners for IMMU-132 and plans for further development of IMMU-132 beyond mTNBC," he further stated.

During the third quarter, Immunomedics achieved the following development milestones:

Results from a Phase 2 study of IMMU-132 in patients with relapsed or refractory metastatic urothelial cancer were updated at the 2017 Genitourinary Cancers Symposium.1 Among the 36 assessable patients, an objective response rate (ORR) of 31%, including one confirmed complete response and ten confirmed partial responses, was reported. The median duration of response for these ten patients was 7.5 months. For the 41 intention-to-treat (ITT) patients, interim median progression-free survival (PFS) and interim median overall survival (OS) were 7.2 months and 15.5 months, respectively.

In patients with metastatic small-cell lung cancer, results with IMMU-132 were updated at the 2017 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).2 Sixty percent of patients showed tumor shrinkage from baseline measurements. On an ITT basis (N= 50), the ORR was 14% and the median response duration was 5.7 months. Median PFS and median OS were 3.7 months and 7.5 months, respectively.

Results with IMMU-132 in heavily-pretreated patients with metastatic triple-negative breast cancer were published online in the Journal of Clinical Oncology.3

On May 10, 2017 Genmab reported interim Report for the First Quarter of 2017 (Press release, Genmab, MAY 10, 2017, View Source [SID1234519031]).

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Highlights
USD 255 million in net sales of DARZALEX (daratumumab); resulting in royalty income of DKK 211 million
DARZALEX received positive opinion from European regulatory authorities for relapsed or refractory multiple myeloma

Judith Klimovsky, MD appointed Chief Development Officer
Phase II study of daratumumab in non-Hodgkin’s lymphoma (CARINA) did not proceed to stage 2 of trial
"In the first quarter of 2017 we received a positive regulatory opinion for DARZALEX in combination with standard therapies for relapsed or refractory multiple myeloma in the EU, and continued to progress our other pipeline projects. As part of our aim to grow into a sustainably profitable company, we also strengthened our executive management team with the appointment of Judith Klimovsky, MD, as Executive Vice President and Chief Development Officer," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2017
Revenue was DKK 251 million in the first quarter of 2017 compared to DKK 170 million in the first quarter of 2016. The increase of DKK 81 million, or 48%, was mainly driven by increased DARZALEX royalties, partly offset by a decrease in milestone income.

Operating expenses were DKK 205 million in the first quarter of 2017 compared to DKK 154 million in the first quarter of 2016. The increase of DKK 51 million, or 33%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and the various products in our pre-clinical pipeline.

Operating income was DKK 46 million in the first quarter of 2017 compared to DKK 16 million in the first quarter of 2016. The increase of DKK 30 million, or 188%, was driven by higher revenue which was partly offset by the increased operating expenses in 2017.

On March 31, 2017, Genmab had a cash position of DKK 4,751 million compared to DKK 3,922 million at December 31, 2016. This represented a net increase of DKK 829 million, which was mainly driven by positive working capital adjustments of DKK 665 million related to milestones achieved in the fourth quarter of 2016 that were received in 2017, proceeds from the exercise of warrants of DKK 103 million, and operating income.

Subsequent Event
April: The European Commission granted a marketing authorization for DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The approval converts the previous conditional marketing authorization for DARZALEX to a full approval. Genmab will receive milestone payments totaling USD 48 million from Janssen in connection with the first commercial sales of DARZALEX under the expanded label. The sales are expected to occur quickly after the approval.

Outlook
Genmab is maintaining its 2017 financial guidance published on February 22, 2017.

On May 10, 2017 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the quarter ended March 31, 2017, and provided an overview of recent accomplishments and upcoming milestones for its research and development programs (Press release, CytRx, MAY 10, 2017, View Source [SID1234519029]).

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"To date, 2017 has been marked by several key achievements, but most importantly, by obtaining clarity from the U.S. Food and Drug Administration (FDA) regarding our soft tissue sarcomas (STS) program and the establishment of a definitive regulatory path toward approval for aldoxorubicin as a treatment for patients with this rare, difficult to treat disease," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "Our Phase 3 trial investigating aldoxorubicin in patients with second-line STS concluded and the data will be used to support our filing strategy."

"Finally, we look forward to presenting the more detailed and updated global Phase 3 STS results to the medical community at the upcoming 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. This Phase 3 trial, along with the combination trial of aldoxorubicin with ifosfamide/mesna, continue to build upon the body of clinical data supporting aldoxorubicin’s potential as a new and better treatment for patients with STS," Mr. Kriegsman commented.

First Quarter 2017 and Recent Highlights

Strengthened the Balance Sheet with $15 Million in Financing and $2 Million in Warrant Proceeds. In early May 2017, CytRx completed the sale of approximately 30 million shares of common stock in a public offering at a price of $0.50 per share, resulting in net proceeds to the Company of approximately $13.9 million after deducting placement agent’s fees and other estimated offering expenses. Additionally, the Company received approximately $1.9 million from the exercise of warrants resulting in a total raise of $15.8 million subsequent to March 31, 2017.

Concluded Phase 3 Trial Evaluating Aldoxorubicin in Relapsed or Refractory STS. Based on its goal to submit a rolling NDA, subject to approval from the FDA, the Company has concluded its Phase 3 study evaluating aldoxorubicin compared to investigator’s choice in patients with relapsed or refractory STS.

Aldoxorubicin Clinical Trial Data in Patients with STS Selected for Oral Presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper). In April 2017, CytRx announced that an abstract describing results from its global Phase 3 clinical trial evaluating aldoxorubicin versus investigators’ choice in patients with relapsed and refractory STS was selected for an oral presentation at ASCO (Free ASCO Whitepaper) 2017, taking place June 2-6, 2017 in Chicago. The oral presentation (abstract #11000) will be given by Principal Investigator, Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, on Friday, June 2, 2017 between 3:00-6:00 pm CT. In addition to the STS presentation, a poster (abstract #11051) highlighting updated data from CytRx’s ongoing Phase 1/2 clinical trial combining aldoxorubicin with ifosfamide/mesna in patients with first-line soft tissue sarcomas will also be presented by Frederick C. Eilber, M.D., Director of the UCLA Sarcoma Translational Research Program within the Jonsson Comprehensive Cancer Center, on Sunday, June 4, 2017 between 8:00-11:00 am CT.

Announced FDA Agreement on Regulatory Pathway to Approval for Aldoxorubicin in STS. In April 2017, CytRx announced that it had reached an agreement with the FDA on the pathway for a NDA submission for aldoxorubicin as a treatment for STS. The Company’s goal is to submit a rolling NDA under section 505(b)(2) to the FDA in the fourth quarter of 2017. The commercial launch of aldoxorubicin is projected for 2018 in the U.S. Aldoxorubicin has received Orphan Drug Designation from the FDA for the treatment of STS, which provides for several benefits including seven years of market exclusivity after approval, certain R&D related tax credits and protocol assistance from the FDA. CytRx also plans to discuss with the European Medicines Agency a path to filing a Marketing Authorization Application. European regulators granted aldoxorubicin Orphan Medicinal Product Designation for STS which confers ten years of market exclusivity among other benefits.

Upcoming Milestones

Present results from the Company’s pivotal Phase 3 clinical trial evaluating aldoxorubicin compared to investigator’s choice in patients with relapsed or refractory STS in an oral presentation at ASCO (Free ASCO Whitepaper) 2017.
Present updated data from the ongoing Phase 1b/2 clinical trial of aldoxorubicin in combination with ifosfamide/mesna in patients with advanced sarcomas in a poster presentation at ASCO (Free ASCO Whitepaper) 2017.
Report top-line results from the global Phase 2b clinical trial evaluating aldoxorubicin versus topotecan in patients with second-line SCLC in the second quarter of 2017.
Obtain FDA’s permission to initiate a rolling NDA during 2017.
Select the first internally developed ultra-high potency drug conjugate candidate from its laboratory in Freiburg, Germany, for future development during 2017.
First Quarter 2017 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $48.0 million as of March 31, 2017.

On May 2, 2017, CytRx completed a public offering of 30 million shares of its common stock at a price of $0.50 per share. The net proceeds to CytRx from the offering, after deducting placement agent’s fees and other estimated offering expenses, were approximately $13.9 million. In addition, CytRx received $1.9 million in proceeds from the exercise of warrants in April and May 2017.

Net loss for the quarter ended March 31, 2017, was $11.0 million, or $(0.10) per share, compared with a net loss of $12.6 million, or $(0.19) per share, for the quarter ended March 31, 2016. During the first quarter of 2017, the Company recognized a non-cash loss of $0.03 million on the fair value adjustment of warrant derivative liability related to warrants issued in 2016, compared to a non-cash loss of $0.2 million during the first quarter of 2016 related to now expired warrants.

Research and development (R&D) expenses were $6.8 million for the first quarter of 2017, and included development expenses of $4.0 million for aldoxorubicin, approximately $0.6 million for pre-clinical development of new albumin-binding, ultra-high potency cancer drugs (German lab), and approximately $2.2 million for general operation of our clinical programs. R&D expenses were $8.2 million for the first quarter of 2016.

General and administrative (G&A) expenses were $3.0 million for the first quarter of 2017, compared with $4.0 million for the first quarter of 2016.