On May 11, 2016 Transition Therapeutics Inc. ("Transition" or the "Company") (TSX: TTH; NASDAQ: TTHI), a biopharmaceutical development company advancing novel therapeutics for CNS, metabolic disease and androgen deficiency indications, reported its financial results for the three and nine month periods ended March 31, 2016 (Press release, Transition Therapeutics, MAY 11, 2016, View Source [SID:1234512277]). Investors are invited to participate in a conference call today at 4:30pm EST to discuss these results. Dial in information for the call is as follows: (800) 698-9012 (North America) and (303) 223-4374 (International). A live webcast can be accessed via Transition’s website www.transitiontherapeutics.com, with a replay available for seven days following the call.

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Selected Highlights
Highlights for the Company during the nine month period ended March 31, 2016 and up to the date of this press release include the following:

ELND005:
ELND005 is an oral small molecule drug candidate with a proposed dual mechanism of action which includes β-amyloid anti-aggregation and regulation of brain myo-inositol levels. Transition’s subsidiary Transition Therapeutics Ireland ("TTIL") owns all ELND005 development and commercialization rights.

October 28, 2015 – Transition announced that data from the Phase 2/3 clinical study of ELND005 in Alzheimer’s disease patients with moderate and severe agitation and aggression was presented at the Clinical Trials in Alzheimer’s Disease (CTAD) meeting. A copy of the CTAD oral presentation is available on the Company website at www.transitiontherapeutics.com;
October 15, 2015 – Transition announced that its subsidiary, TTIL, has completed a thorough review of the data related to the Phase 2/3 study of ELND005 in AD patients with moderate or severe agitation and aggression. The analysis identified a significant clinical benefit of ELND005 in AD patients with severe agitation and aggression, and will serve as the basis for patient selection in a Phase 3 clinical study. The review was performed in consultation with a group of key opinion leaders in the field of neuropsychiatry.

TT401:
TT401 is an oxyntomodulin analogue that has dual agonist activity of the GLP-1 (Glucagon-Like Peptide-1) and glucagon receptors.
April 18, 2016 – Transition announced that Lilly will not elect to advance diabetes drug candidate, TT401 into Phase 3 development. Under the companies’ collaboration agreement, all TT401 development and commercialization rights will be transferred to Transition. Transition is unencumbered to advance TT401 on its own or with a third party;
February 1, 2016 – Transition announced the results of a Phase 2 clinical study of drug candidate TT401 (LY2944876) for the treatment of type 2 diabetes. TT401 development collaborator Eli Lilly and Company performed the Phase 2 study enrolling 420 type 2 diabetes subjects into a 24 week study consisting of a 12-week randomized blinded stage followed by a 12-week open-label stage. The study included 4 once-weekly dose arms of TT401 (10mg, 15mg, 30mg, 50mg), a placebo arm, and an active comparator arm (exenatide extended release – 2mg). TT401 demonstrated HbA1c improvements of up to -1.43% (similar to the exenatide arm). All TT401 dose arms and the exenatide arm were statistically significant relative to the placebo arm at Weeks 12 and 24. TT401 also produced dose dependent weight loss (up to -3.3 kg). The weight loss observed in the highest dose arm (50mg of TT401) was statistically significant relative to both the placebo and exenatide arms at weeks 12 and 24.

TT701 SARM:
TT701 is an oral drug candidate that is a selective androgen receptor modulator (SARM). TTIL owns all TT701 development and commercialization rights. TT701 is in Phase 2 clinical development as a therapy to ameliorate the symptoms associated with androgen deficiency.

April 25, 2016 – Transition announced the dosing of the first patient of a Phase 2 study of selective androgen receptor modulator (SARM) drug candidate TT701. Brigham and Women’s Hospital (BWH) is conducting the investigator-led Phase 2 clinical study which is expected to enroll up to 125 subjects at selected specialized clinical sites including BWH. The principal investigator for the Phase 2 study is Dr. Shalender Bhasin, Director of the Research Program in Men’s Health: Aging and Metabolism at BWH and an internationally recognized endocrinologist with expertise in testosterone biology and men’s aging;
October 29, 2015 – Transition announced that its subsidiary, TTIL, has entered into an agreement with BWH for an investigator-led clinical study of drug candidate TT701. TTIL will support a Phase 2 study to evaluate SARM drug candidate TT701 as a therapy to improve the symptoms of androgen deficiency in men with prostate cancer that have undergone a radical prostatectomy procedure.

Financial Liquidity
At March 31, 2016, the Company had cash resources of $24,768,772 and a working capital of $23,095,324.
The Company’s current cash projection indicates that the existing cash resources should enable the Company to execute its core business plan and meet its projected cash requirements beyond the next 12 months.

Financial Review
During the three month period ended March 31, 2016, the Company recorded a net loss of $4,177,942 ($0.11 loss per common share) compared to a net loss of $4,748,096 ($0.13 loss per common share) for the three month period ended March 31, 2015.
For the nine month period ended March 31, 2016, the Company recorded a net loss of $10,675,178 ($0.28 loss per common share) compared to a net loss of $37,353,559 ($1.04 loss per common share) for the nine month period ended March 31, 2015.

Research and Development
Research and development expenses decreased by $3,309,363 from $4,888,272 for the three month period ended March 31, 2015 to $1,578,909 for the three month period ended March 31, 2016. For the nine month period ended March 31, 2016, research and development expenses decreased $28,860,717 to $7,967,335 from $36,828,052 for the same period in fiscal 2015.
The decreases in research and development expenses for both the three and nine month periods ended March 31, 2016 are primarily due to a decrease in clinical development costs related to ELND005 and reduced salary and related expenses which resulted from cost cutting efforts. The decrease in research and development expenses for the nine month period ended March 31, 2016 is also due to a decrease in funding obligations relating to TT401 as the Company paid US$14 million in milestone payments to Lilly during the comparative nine month period.

General and Administrative
General and administrative expenses decreased by $69,073 from $1,268,531 for the three month period ended March 31, 2015 to $1,199,458 for the three month period ended March 31, 2016. For the nine month period ended March 31, 2016, general and administrative expenses increased $40,848 to $3,818,660 from $3,777,812 for the same period in fiscal 2015.
The decrease in general and administrative expenses for the three month period ended March 31, 2016 are primarily due to reduced professional fees which have been partially offset by inflationary increases in compensation costs.
The increase in general and administrative expenses for the nine month period ended March 31, 2016 are primarily due to business taxes paid for the Company’s US subsidiary and inflationary increases in compensation costs which have been partially offset by reduced professional fees.

On May 11, 2016 Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported its financial results and business highlights for the first quarter ended March 31, 2016 (Press release, Cyclacel, MAY 11, 2016, View Source [SID:1234512282]).

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The Company’s net loss applicable to common shareholders for the first quarter ended March 31, 2016 was $3.1 million, or $0.09 per basic and diluted share, compared to net loss applicable to common shareholders of $5.0 million, or $0.19 per basic and diluted share for the first quarter ended March 31, 2015. As of March 31, 2016, cash and cash equivalents totaled $17.1 million.

"In SEAMLESS, our Phase 3 pivotal study in acute myeloid leukemia (AML), approximately 2.6% of required events remain to be observed before mature data become available," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The primary endpoint of the study is overall survival. After top-line data readout, the mature data will be evaluated for submissibility to regulatory authorities. In parallel, we have been progressing our CDK inhibitor programs. We have reported encouraging interim data from the ongoing Phase 1/2 combination trial of seliciclib and sapacitabine in solid tumors, including durable partial responses and stable disease in patients with BRCA positive breast, ovarian and pancreatic cancers. Updated data from this combination study will be reported in an oral presentation at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting. In light of these data and investigator interest, we started enrollment of an extension cohort in a BRCA-enriched population of breast cancer patients. We continue to enroll patients in a first-in-human, Phase 1 study of CYC065, our second-generation CDK2/9 inhibitor, in patients with solid tumors and lymphomas. Data presented at the AACR (Free AACR Whitepaper) Annual Meeting 2016 highlighted CYC065’s potential as an agent to treat hematological malignancies, such as B-cell lymphoma. The Cyclacel team continues to pursue the vision of our founders, as appreciation of the importance of CDK inhibitors is increasing among the medical community."

Recent Business Highlights

SEAMLESS Study

Continued follow up of patients enrolled in SEAMLESS, a Phase 3 study of orally-administered sapacitabine alternating with intravenous decitabine compared to decitabine alone, as first-line treatment in patients aged 70 years or older with AML who are unfit or refused intensive chemotherapy.
Approximately 2.6% of the pre-specified events remain to be observed until mature data become available for analysis.
Cyclin Dependent Kinase (CDK) 2/9 Inhibitor Programs

Continued patient follow-up in a Phase 1/2 combination study of seliciclib and sapacitabine in patients with advanced solid tumors. In the first part of the study, several patients with BRCA positive breast, ovarian and pancreatic cancers achieved durable partial responses and stable disease.
Started enrollment of an extension cohort in a BRCA-enriched population of patients with breast cancer.
Dosed the fourth dose escalation level in the first-in-human, Phase 1 trial of CYC065, a second-generation CDK2/9 inhibitor, to evaluate safety, tolerability and pharmacokinetic profile in patients with solid tumors and lymphomas.
Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 demonstrating the therapeutic potential of CYC065 as a targeted anti-cancer agent in B-cell lymphoma, including double-hit lymphomas, and beneficial combinations with Bcl-2 (venetoclax) and BET inhibitors. The data validate the mechanism of action of CYC065, which is to reduce MYC and Mcl-1 levels, both of which can be elevated in B-cell lymphoma.
Cyclacel’s Key Milestones for 2016

Sapacitabine in SEAMLESS

Continue follow-up of patients until the requisite number of events occur, which is anticipated around the end of the first half of 2016.
Report top-line results.
Determine submissibility to regulatory authorities for marketing approval following analysis of the mature data set.
Progress a Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
Sapacitabine in myelodysplastic syndromes (MDS):

Initiate a Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.
Plan a Phase 2 randomized controlled trial (RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.
CDK Inhibitor Programs

Progress the seliciclib and sapacitabine Phase 1/2 extension study in a breast cancer patient population enriched for BRCA mutations.
Report at an oral presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting updated seliciclib and sapacitabine Phase 1/2 data in patients with advanced solid tumors.
Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors and lymphomas.
Report data when available from on-going investigator sponsored trials (ISTs) evaluating seliciclib in patients with Cushing’s disease, rheumatoid arthritis, and in cystic fibrosis though a license and supply agreement with ManRos Therapeutics.
First Quarter 2016 Financial Results

Grant Revenue

Revenue for the three months ended March 31, 2016 was $0.1 million compared to $0.5 million for the same period of the previous year. The revenue is related to previously awarded grants from the UK government being recognized over the period to progress CYC065 to IND and complete IND-directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor.

Research and Development Expenses

Research and development expenses decreased to $2.5 million for the three months ended March 31, 2016 compared to $4.3 million for the same period in the previous year. The decrease was primarily due to reduced study and clinical supply costs associated with the SEAMLESS Phase 3 trial, which completed enrollment in December 2014, offset by increased expenditures primarily related to the first-in-human, Phase 1 study of CYC065 and grant supported research and development.

General and Administrative Expenses

General and administrative expenses for the three months ended March 31, 2016 decreased to $1.4 million compared to $1.5 million for the same period in 2015.

Based on current plans, the Company estimates that it has capital resources to reach beyond the final analysis of SEAMLESS and continue existing programs through the end of 2017.

On May 11, 2016 Cellectis S.A. (Alternext: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported its results for the three-month period ended March 31, 2016 (Press release, Cellectis, MAY 11, 2016, View Source [SID:1234512287]).

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"We are excited to monitor the results presented by Great Ormond Street Hospital – University College of London describing clinical application of allogeneic, off-the-shelf CAR T-cells in young ALL patients with high medical need who exhausted all other treatment options. We are looking forward to seeing more data updates from our partners and bringing our CAR T-cell programs into the clinic, starting with UCART123 for AML patients" said André Choulika, CEO, Cellectis.

Recent Corporate Highlights
• New agreement with CELLforCURE for the cGMP manufacturing of clinical batches of UCART123, Cellectis’ lead product candidate, and for the implementation of cGMP manufacturing processes designed and developed by Cellectis.

• Supply and license agreement with Takara Bio Inc. for recombinant human fibronectin fragment RetroNectin to support Cellectis’ manufacturing processes and production capabilities.

• Publication in Scientific Reports, part of Nature Publishing Group, describing the design and development of a new CAR architecture with an integrated switch-on system that allows control over CAR T-cell functions.

• Research collaboration and license agreement with MabQuest SA for the development of a new class of anti PD-1 monoclonal antibodies.

• Cellectis gave a presentation at the Cowen and Company 36th Annual Health Care Conference on March 9, 2016 in Boston, MA.

• Scientific presentations at AACR (Free AACR Whitepaper), New Orleans:

Allogeneic TCRα/CS1 double knockout T-cell bearing an anti-CS1 chimeric antigen receptor: an improved immunotherapy approach for the treatment of Multiple Myeloma, presented by Roman Galetto, Cellectis.
Improved safety by a non-lethal switch to control CAR activity at the T-cell surface membrane, presented by Laurent Poirot, Cellectis.
• Appointment of Dr. Loan Hoang-Sayag to the role of Chief Medical Officer. Dr. Hoang-Sayag joined Cellectis from Quintiles Transnational, where she was most recently Senior Director of Medical Science.

• Calyxt, Cellectis’ plant science subsidiary, has purchased a 10-acre parcel in the St. Paul suburb of Roseville, MN, to build a new greenhouse and company headquarter.

Financial Results
As previously announced, commencing with this report of first quarter results Cellectis will now publish quarter-over-quarter comparative figures.

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board ("GAAP").

First Quarter 2016 Financial Results

Cash: As of March 31, 2016 Cellectis had €276.5 million in total cash, cash equivalents and current financial assets compared to €314.2 million as of December 31, 2015. This notably reflects (i) the initiation of industrial GMP UCART123 production, (ii) increased expenses in GMP materials (iii) payment of €7.2 million of Value Added Taxes related to the proceeds received in the fourth quarter of 2015 from Servier and (iv) Calyxt’s acquisition of a 10-acre parcel for €5.2 million. The change was also attributable to the unrealized translation effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts.

Revenues and Other Income: During the three months ended March 31, 2015 and 2016, we recorded €9.2 million and €9.5 million, respectively, in revenues and other income.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the first quarter of 2016 were €29.9 million, compared to €12.8 million for the first quarter of 2015. The non-cash stock-based compensation expenses included in these amounts were €13.4 million and €0.8 million, respectively.

R&D Expenses: For the three months ended March 31, 2015 and 2016, research and development expenses increased by €11.4 million from €7.4 million in 2015 to €18.9 million in 2016. Personnel expenses increased by €7.2 million from €4.7 million in 2015 to €11.9 million in 2016, notably due to a €1.0 million increase in wages and salaries, and a €7.2 million increase in non-cash stock based compensation expense, partly offset by a €1.0 million decrease in social charges on stock option and free shares grants. Purchases and external expenses increased by €4.2 million from €2.4 million in 2015 to €6.6 million in 2016, due to increased expenses related to innovation and platform development, including payments to third parties participating in product development, purchases of biological raw materials and expenses associated with the use of laboratories and other facilities.

SG&A Expenses: During the three months ended March 31, 2015 and 2016, we recorded €5.4 million and €10.5 million, respectively, of selling, general and administrative expenses. The increase of €5.2 million primarily reflects (i) an increase of €4.5 million in personnel expenses from €3.7 million to €8.3 million, attributable, among other things, to an increase of €5.4 million of non-cash stock-based compensation expense, partly offset by a decrease of €1.1 million of social charges on stock options and free share grants, and (ii) an increase of €0.8 million in purchases and external expenses.

Financial gain (loss): The financial gain was €9.9 million for the first quarter of 2015 compared with financial loss of €9.1 million for the first quarter of 2016, which does not reflect actions undertaken to mitigate the impact of currency exchange rate fluctuations that were adopted at the end of the first quarter of 2016. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts.

Net Loss Attributable to Shareholders of Cellectis: During the three months ended March 31, 2015 and 2016, we recorded a net income of €6.3 million (or €0.20 per share on a basic basis and €0.19 per share on a diluted basis) and a loss of €29.5 million (or €0.84 per share on both a basic and diluted basis), respectively. Adjusted net loss attributable to shareholders of Cellectis for the first quarter of 2016 was €16.1 million (€0.46 per share on both a basic and a diluted basis) compared to adjusted net income attributable to shareholders of Cellectis of €7.0 million (€0.22 per share on both a basic and a diluted basis), for the first quarter of 2015. Adjusted net income (loss) attributable to shareholders of Cellectis for the first quarter of 2016 and 2015 excludes a non-cash stock-based compensation expense of €13.4 million and €0.8 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income to adjusted net income.

Financial Guidance: Cellectis expects that its cash, cash equivalents and Current financial assets of €276.5 million as of March 31, 2016 will be sufficient to fund its current operations through 2018.

On May 11, 2016 Pfizer Inc. (NYSE:PFE) reported that it has awarded a total of more than $1 million in funding to five leading breast cancer advocacy organizations to support projects focused on metastatic breast cancer (MBC) scientific research and quality-of-life studies (Press release, Pfizer, MAY 11, 2016, View Source [SID:1234512253]). The awards are part of Pfizer’s Breast Cancer: A Story Half Told initiative, aimed at uncovering gaps in the public’s knowledge of MBC and bringing greater attention to the unique needs and experiences of people living with this disease. The need for greater research funding is among the most pressing the MBC community faces, with only about 7 percent of the total breast cancer investment focused on MBC.1

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"These awards – which support advocacy-led, metastatic-focused research efforts – are an important addition to the Story Half Told initiative," said Matt Shaulis, regional president, North America, Pfizer Oncology. "They also are aligned with Pfizer’s broader commitment to drive scientific advancement in breast cancer across stages and beyond our walls, building on the more than $35 million we have invested in unique breast cancer and metastatic breast cancer research funding partnerships over the last three years."

"Since the launch of Story Half Told in 2014, we have worked with our partners to bring greater attention to the needs of people with metastatic breast cancer so they are not lost in the broader breast cancer conversation," said Dr. Julia Perkins Smith, North America Medical Affairs lead, Pfizer Oncology. "We are proud to support the meaningful work being done by the advocacy community to help improve the outlook for people living with metastatic disease."

The following five organizations have received supportive funding from Pfizer’s Story Half Told initiative:

Breast Cancer Research Foundation (link is external)
Dr. Susan Love Research Foundation (link is external)
Metastatic Breast Cancer Network (link is external)
METAvivor (link is external) – Metastatic Breast Cancer Awareness, Research and Support
Susan G. Komen (link is external) – Young Investigators in MBC
"Metastatic breast cancer patients are in great need of treatment advances that will both extend and improve the quality of our lives – and that doesn’t come without focused research," said Shirley Mertz, president, Metastatic Breast Cancer Network (MBCN). "I am pleased not only that MBCN has received this funding from Pfizer to support our research efforts, but that the other four recipient organizations will also be pursuing projects to help further the scientific understanding of metastatic breast cancer and impact the way it is treated."

Metastatic breast cancer, also known as Stage 4 breast cancer, occurs when cancer has spread beyond the breast to other parts of the body, including the bones, liver, lungs or brain.2,3 An estimated 150,000-250,000 women in the U.S. are living with MBC, and face a median survival of three years following diagnosis.4,5,6,7,8

In September 2015, Pfizer and leaders in the breast cancer community launched the most recent chapter of the Breast Cancer: A Story Half Told initiative, inspired by the findings from a 2014 public survey in which the majority of Americans surveyed reported they knew little to nothing about MBC.9 This latest chapter focuses on the personal stories of women with MBC as captured through poignant photography. In 2015, five well-known photographers and five women with MBC joined the program, and their stories continue to be featured on www.storyhalftold.com (link is external) and the Story Half Told social media channels (Instagram, Facebook and Twitter). In the coming months, the stories of additional women with MBC will be shared through photography and video vignettes that will be released on the website and social channels.

More About Breast Cancer: A Story Half Told

Pfizer launched Breast Cancer: A Story Half Told in October 2014 hand-in-hand with a steering committee of patient advocates, healthcare professionals and subject-matter experts by unveiling research aimed at understanding the societal misperceptions of MBC and gaps in patient-physician dialogue. These results culminated in a public call-to-action to heighten understanding and knowledge of MBC within society as whole and improve patient-physician conversations, both areas that Story Half Told continues to address.

A survey of 2,000 U.S. adults conducted as part of the launch in 2014 revealed:9

More than 60% of respondents reported they know little to nothing about MBC.
Widespread misperceptions exist around the disease, including:
72% incorrectly believed that breast cancer in the advanced stages is curable if diagnosed early.
50% incorrectly believed breast cancer progresses because patients either did not take the right treatment or preventative measures.

On May 11, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the three months ended March 31, 2016, and provided an overview of recent accomplishments and upcoming milestones for its research and development programs (Press release, CytRx, MAY 11, 2016, View Source;p=RssLanding&cat=news&id=2167453 [SID:1234512256]).

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"So far, 2016 has been a very productive year for CytRx," said Steven A. Kriegsman, Chairman and CEO of CytRx. "On the clinical front, we reached the 191 progression events in our global, pivotal Phase 3 trial with aldoxorubicin in second-line soft tissue sarcoma to trigger the data verification and analysis. We look forward to announcing top-line results at the end of June 2016. We announced that we will present updates on three aldoxorubicin clinical trials at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2016. Additionally, our team recently presented data at the American Association of Cancer Research Annual Meeting on our LADRTM technology platform and on DK049, the first drug to emerge from that platform."

Mr. Kriegsman continued: "On the corporate side, we added commercial oncology expertise with the addition of Ms. Olivia Ware to our executive management team. We also raised an additional $25 million in non-dilutive capital to fund clinical and pre-commercial activities for aldoxorubicin."

First Quarter 2016 and Recent Highlights

Bolstered the Management Team. In January 2016, CytRx hired Ms. Olivia Ware as Chief Commercial Officer. Ms. Ware brings more than 20 years of biotechnology and pharmaceutical experience, including thirteen years at Genentech where she was responsible for key aspects of the launches of the oncology drugs Rituxan, Herceptin and Avastin. While at Genentech, Ms. Ware was a Senior Director of Oncology and was responsible for the initial commercial launch of Avastin in the U.S., which reached $1 billion in sales during its first year on the market. Prior to this, she was head of Herceptin marketing and held a number of other positions in the commercial organization. Later, Ms. Ware was a Senior Director in the Product Portfolio Management Group, managing approximately 20 senior leaders responsible for building and leading the cross-functional drug development teams that developed and implemented strategic plans and guided the drug development processes for all oncology products at Genentech.

Strengthened the Balance Sheet. In February 2016, CytRx entered into a long-term loan for up to $40 million with Hercules Technology Growth Capital. The initial tranche of $25 million was received, and CytRx can access an additional $15 million, subject to certain research and development milestones.

Reached the Target Number of Events in the Global Pivotal Phase 3 Trial. In April 2016, CytRx achieved the target number of progression events in the aldoxorubicin global, pivotal Phase 3 trial in patients with second-line soft tissue sarcomas. Our contract research organization started the collection and verification of the trial data from all 433 patients enrolled at 79 sites around the globe. CytRx expects to report top-line results following the analysis of the data in June 2016.

Presented Data on LADRTM Technology Platform and DK049. In April 2016, CytRx presented two posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting detailing both our Linker Activated Drug Release (LADRTM) Platform and DK049, an albumin-binding derivative of the widely used chemotherapy agent gemcitabine combined with our LADRTM technology. DK049 was nominated for clinical development in 2015.

Upcoming Milestones

Present updated aldoxorubicin clinical trial results at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2016 from the ongoing Phase 2 clinical trial in patients with unresectable glioblastoma, the Phase 2 clinical trial in Kaposi’s sarcoma and from the Phase 1b combination trial with gemcitabine in patients with advanced cancers
Announce top-line results from the global pivotal Phase 3 clinical trial with aldoxorubicin as a treatment for patients with second-line soft tissue sarcomas
Present aldoxorubicin pivotal Phase 3 clinical trial results at a major medical meeting
Complete enrollment in the global Phase 2b clinical trial evaluating aldoxorubicin in patients with second-line small cell lung cancers
First Quarter 2016 Financial Results

CytRx reported cash, cash equivalents and short term investments of $68.2 million as of March 31, 2016.

Net loss for the quarter ended March 31, 2016 was $12.6 million, or $0.19 per share, compared with a net loss of $17.5 million, or $0.31 per share, for the quarter ended March 31, 2015. During the first quarter of 2016, CytRx recognized a non-cash loss on warrant derivative liability of $0.2 million, compared to a non-cash loss of $1.9 million for the three-month period ended March 31, 2015. The Company did not recognize revenues for the first quarters of 2016 or 2015.

Research and development (R&D) expenses were $8.2 million for the first quarter of 2016, and included development expenses of $5.8 million for the aldoxorubicin program. R&D expenses were $12.6 million for the first quarter of 2015.

General and administrative (G&A) expenses were $4.0 million for the first quarter of 2016, compared to $3.1 million for the first quarter of 2015.

About Soft Tissue Sarcoma
Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About Small Cell Lung Cancer
An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year. In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use. The five year survival rate is less than 7%, in part because an estimated 70% of patients have extensive disease at diagnosis. According to the National Cancer Institute, more than 30,000 new cases will be diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.

About Glioblastoma Multiforme
Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. The median survival after diagnosis is approximately 14 months, despite patients subsequently receiving surgical resection, radiotherapy and chemotherapy. 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 450 mg/m2. 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 (3 ½ to 4 times) 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 2,000 mg/m2.

About DK049
DK049 is a novel LADRTM-enhanced derivative of the commonly used chemotherapeutic agent gemcitabine. Like aldoxorubicin, DK049 binds to circulating albumin for transport to the tumor. It incorporates a novel dual-releasing linker that is cleaved in an acidic environment and requires a specific enzyme for prolonged release of the active drug at the tumor site. DK049 appears to overcome the major deactivation and resistance mechanisms that limit the effectiveness of gemcitabine. Preclinical studies in animal models of non-small cell lung, pancreatic and ovarian cancers showed superior anti-tumor activity compared to gemcitabine. CytRx recently presented preclinical data on DK049 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2016.