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.

On May 11, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported its financial results for the first quarter ended March 31, 2016 (Press release, Heat Biologics, MAY 11, 2016, View Source [SID:1234512295]).

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"We are focused on achieving near-term milestones to rebuild shareholder value. Our primary goal is to advance HS-410 for the treatment of non-muscle invasive bladder cancer with one-year disease-free survival, immune response, safety and tolerability data expected in the fourth quarter of this year," said Jeff Wolf, Heat’s Founder and CEO. "In addition, we are looking forward to presenting new data at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting in June around our Phase 1b trial evaluating HS-110 in combination with an anti-PD-1 checkpoint inhibitor for the treatment of non-small cell lung cancer."

Recent Developments & First Quarter 2016 Corporate Highlights

In May, Heat had an abstract accepted for poster presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting being held on June 3-7, 2016 in Chicago, IL. The poster is entitled "Broadening response rates to PD-1 therapy in advanced lung adenocarcinoma: Viagenpumatucel-L (HS-110) in combination with nivolumab in the ongoing DURGA trial" (Abstract #TPS9102). Abstracts will be made available on the ASCO (Free ASCO Whitepaper) website at www.asco.org in line with the conference’s embargo policy.

In April, Heat presented three posters at the AACR (Free AACR Whitepaper) Annual Meeting. In the poster entitled "Phase I/II Study of Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Treated with Vesigenurtacel-L (HS-410) with or without BCG," Heat reported that no additional recurrences had been reported to-date, with all patients now at least 18 months out from enrollment. In another poster, Heat reported initial preclinical results from its collaboration with OncoSec Medical Incorporated in which researchers concluded that combining Heat’s ComPACT vaccine with OncoSec’s intratumoral DNA electroporation delivery platform stimulated an expansion of neoantigen-specific CD8+ T cells, leading to a regression in both treated and untreated cancer lesions in two mouse studies. In the third poster, Heat reported positive preclinical data on its next generation ComPACT platform technology, which combines a T cell priming vaccine and a T cell co-stimulator in a single product.

In April, Heat implemented cost-saving measures and a focused corporate strategy to achieve data readout, with its current cash on-hand, anticipated in the fourth quarter of 2016 for its lead Phase 2 program evaluating HS-410 for the treatment of NMIBC. These cost-saving measures included a workforce reduction of approximately 22 percent of the company’s headcount.

In April, Heat appointed John Prendergast, Ph.D., to its Board of Directors.

In March, Heat closed a public offering of approximately $6.8 million in gross proceeds, which will primarily be used to complete its Phase 2 clinical trial evaluating HS-410 for the treatment of NMIBC. Remaining funds will be used to advance the current eight patients enrolled in our Phase 1b trial evaluating HS-110 in combination with nivolumab for the treatment of non-small cell lung cancer (NSCLC) through the reporting of topline data, as well as for licensing or acquisition of assets complementary to our existing programs and working capital and general corporate purposes.

In March, Heat presented additional preclinical data from its ComPACT platform technology at the Keystone Symposia on Cancer Vaccines. Data presented demonstrated that ComPACT secreting OX40L generated the most potent immune response among other ComPACT co-stimulator variations including TL1A, 4-1BBL and ICOSL, as well as compared to systemic delivery of OX40 agonist antibody and vaccine alone.

In February, Heat announced that it will no longer enroll new patients in its Phase 2 monotherapy trial arm evaluating HS-410 alone for the treatment of NMIBC following the resolution of the standard of care BCG shortage and discussions with the U.S. FDA. Heat anticipates reporting topline 6-month data from the 16 enrolled patients in the fourth quarter of 2016, contemporaneous with reporting data from Heat’s BCG combination cohorts.

In February, Heat announced that the U.S. FDA lifted the partial clinical hold on its HS-410 Phase 2 clinical trial and patient enrollment was resumed after less than one week; clinical timelines were materially unchanged. The partial clinical hold came after Heat concluded that the cell line on which HS-410 is based had been previously misidentified and immediately notified FDA of this conclusion. The FDA placed Heat’s HS-410 Phase 2 clinical trial on partial clinical hold while they reviewed updated documentation. The partial clinical hold did not relate to concerns regarding the safety or efficacy of HS-410.

In January, Heat reported three-month interim data from the unblinded, monotherapy arm in its Phase 2 trial evaluating HS-410 for the treatment of NMIBC. Images of the bladder taken from several patients treated with HS-410 alone showed changes that resemble T cell-rich structures that Heat has observed in biopsy samples, indicating that systemic administration with HS-410 leads to a localized immune response within the bladder that cannot be attributed to standard of care.

First Quarter 2016 Financial Highlights

Research and development expenses decreased to approximately $500,000 in the first quarter of 2016 compared to approximately $504,000 in the first quarter of 2015, a decrease of approximately $4,000. The decrease is attributable to reductions in patent, license and other professional fees offset by compensation costs associated with new hires, as well as supplies and facilities as we bring more capabilities in-house.

Clinical and regulatory expenses increased to approximately $3.2 million in the first quarter of 2016 compared to approximately $2.2 million in the first quarter of 2015, an increase of approximately $1.0 million. The increase is attributable to clinical trial execution expenses, personnel costs and expenses related to the production of our clinical trial material.

General and administrative expenses decreased to approximately $1.0 million in the first quarter of 2016 compared to approximately $1.3 million in the first quarter of 2015, a decrease of approximately $0.3 million. The decrease is attributable to non-cash stock compensation expense for non-employees associated with the company’s reduced shared price, as well as reduced professional services and third party expenses.

Net loss for the first quarter of 2016 was $4.7 million compared to a net loss of $4.0 million for the first quarter of 2015.

Cash, cash equivalents and short-term investments totaled approximately $11.8 million at March 31, 2016 compared to $11.6 million at December 31, 2015. This includes the $6.1 million in net proceeds raised during our March 2016 public offering.