On November 10, 2015 Bio-Path Holdings, Inc., (NASDAQ: BPTH) ("Bio-Path"), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery technology to develop a portfolio of targeted nucleic acid cancer drugs, reported operational and financial results for the quarter ended September 30, 2015 (Filing, 8-K, Bio-Path Holdings, NOV 10, 2015, View Source [SID:1234508200]).

"The third quarter of 2015 proved to be an exciting time for Bio-Path, as we made significant progress with our lead product candidate, BP1001," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "We reported that one patient with advanced acute myeloid leukemia in our Phase Ib trial achieved complete remission, and another patient continued to steadily improve on treatment. In addition, we continued advancing our second asset, BP1002, and are preparing for it to enter the clinic to address unmet needs in patients with solid tumors and lymphomas."

Third Quarter 2015 and Recent Operational and Corporate Highlights:

· Successful completion of Cohort 7 of Bio-Path’s Phase Ib clinical trial evaluating the toxicity of its lead compound, BP1001 (Liposomal Grb2 antisense), combined with low-dose cytarabine (LDAC) chemotherapy in patients with advanced acute myeloid leukemia (AML). Three patients were evaluated in Cohort 7, which was the first cohort of the Company’s Phase Ib trial to evaluate the toxicity of BP1001 as a combination therapy. Patients were treated twice a week for four weeks with 60 mg/m2 of BP1001, for a total of eight doses in combination with the standard regimen of LDAC. Results were consistent with previous cohorts, showing BP1001 to be safe and well tolerated. One patient in Cohort 7 achieved complete remission, and a second patient demonstrated improvement in bone marrow blasts at the end of the first treatment cycle and is continuing BP1001 treatment as part of additional treatment cycles.

· Enrollment opened into the eighth and final cohort of the Phase Ib clinical trial, in which patients will receive dosing with 90 mg/m2 of BP1001 in combination with the standard regimen of LDAC. The Company is finalizing the last cohort of the safety portion for the Phase II combination therapy of BP1001 in AML.

· Continued evaluation of BP1001 in breast cancer through a preclinical program targeting triple negative breast cancer (TNBC) and inflammatory breast cancer (IBC). The preclinical program may be expanded to include a combination therapy evaluation.

· Ongoing preclinical evaluation of a third DNAbilizeTM product. Bio-Path’s product candidate screening and development program produced this promising product candidate, which will diversify the Company’s product pipeline. Potential indications for this new drug candidate include diffuse large B-cell lymphoma, non-small cell lung cancer, pancreatic cancer and disease candidates outside of oncology, such as autoimmune disorders.

· Formation of a Scientific Advisory Board to support the advancement of Bio-Path’s clinical and preclinical therapeutic candidates. Jorge Cortes, M.D., renowned leukemia expert from The University of Texas MD Anderson Cancer Center, joined as Chairman. Amy P. Sing, M.D., a member of Bio-Path’s board of directors and Senior Director of Medical Affairs at Genomic Health, Inc., joined as a founding member.

· Continued enhancement of the Company’s public profile within the investment community and biopharmaceutical industry. Chief Executive Officer Peter Nielsen delivered company presentations at the 17th Annual Rodman & Renshaw Global Investment Conference in September 2015 and the 14th Annual BIO Investor Forum in October 2015.

· Participation in medical meetings and congresses, showcasing the Company’s proprietary technology. Jorge Cortes, M.D., of The University of Texas MD Anderson Cancer Center and Chair of Bio-Path’s inaugural Scientific Advisory Board was selected to present a poster at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 7, 2015 in Orlando, FL. Dr. Cortes will discuss data from the Phase Ib trial of BP1001.

Expected Upcoming Milestones:

· BP1001 in Chronic Myelogenous Leukemia (CML): The Company is finalizing the protocol for its Phase II trial, which will evaluate the efficacy of BP1001 and frontline chemotherapy in patients with CML in blast crisis, an area of unmet medical need. The Company expects to complete preparations to initiate the toxicity portion of this Phase II trial by the end of 2015.

· BP1001 in Acute Myeloid Leukemia (AML): Bio-Path is planning to open a multi-center Phase II clinical trial in AML to evaluate the efficacy of treating patients with BP1001 in combination with LDAC. The combination therapy Phase II trial will enroll older AML patients who are unfit for intense treatment. This patient subset represents a major unmet need for an approach that provides a greater quality of life for patients, while offering an opportunity for clinical development of the compound. The single arm Phase II study is expected to open for enrollment in January 2016.

· BP1002 (Liposomal Bcl2 antisense) in Follicular Lymphoma: The Company is finalizing its Investigational New Drug (IND) Application to begin a Phase I clinical trial in follicular lymphoma with its second liposome-delivered antisense cancer drug candidate. IND filing is anticipated in early 2016.

· BP1002 in multiple oncological and hematological indications: This asset is ready for the clinic, and is intended to target lymphoma, breast cancer, colon cancer, prostate cancer and leukemia. The Company believes that BP1002 may have potential to treat between 40 to 60 percent of solid tumors.

Third Quarter 2015 Financial Highlights:

· The Company reported a net loss of $1.5 million for the three months ended September 30, 2015, compared to a net loss of $1.1 million for the three months ended September 30, 2014. The increase was primarily due to increased drug manufacturing and testing, an increase in drug material used and increased clinical trial expenses. The Company reported a net loss of $0.02 per share for the three months ended September 30, 2015, compared to a net loss of $0.01 per share for the three months ended September 30, 2014. Net loss for the nine months ended September 30, 2015 was $4.0 million, or $0.04 per share, compared to a net loss of $2.9 million, or $0.03 per share, for the nine months ended September 30, 2014. The increase was primarily due to increased manufacturing development, preclinical study costs and clinical trial expenses, as well as personnel costs associated with the addition of research and development support staff in the latter half of 2014.

· Research and development expenses for the three months ended September 30, 2015 increased to $1.0 million, compared to $0.4 million for the three months ended September 30, 2014. For the nine months ended September 30, 2015, research and development expenses increased to $2.1 million, compared to $1.1 million for the nine months ended September 30, 2014.

· General and administrative expenses for the three months ended September 30, 2015 decreased to $0.5 million, compared to $0.7 million for the three months ended September 30, 2014. For the nine months ended September 30, 2015, general and administrative expenses increased to $1.9 million, compared to $1.8 million for the nine months ended September 30, 2014.

· As of September 30, 2015, the Company had cash of $9.9 million, compared to $13.9 million at December 31, 2014. Net cash used in operating activities for the nine months ended September 30, 2015 was $4.0 million, compared to $2.7 million for the comparable period in 2014.

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On November 10, 2015 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported financial results for the three months ended September 30, 2015 and provided a corporate update (Filing, 6-K, Aptose Biosciences, NOV 10, 2015, View Source [SID:1234508199]). Unless specified otherwise, all amounts are in Canadian dollars.

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Effective July 17, 2014 the Company changed its fiscal year end from May 31 to December 31. As a result of this change, the current interim period being reported is for the three months ended September 30, 2015, while the prior year comparative period is for the four months ended September 30, 2014.

Net loss for the three months ended September 30, 2015 was $3.3 million ($0.27 per share) compared with $4.2 million ($0.36 per share) during the four months ended September 30, 2014. Total cash and cash equivalents and investments at September 30, 2015 were $23.4 million.

"During the third quarter of this year we made steady progress in the clinical development of APTO-253 for AML and other blood cancers and we observed favorable safety and pharmacokinetic data that have allowed us to escalate dosing," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "Likewise, the epigenetic insights gained from studies with APTO-253 have been leveraged as we seek to acquire new agents and expand our oncology pipeline at all development stages. This led us to establish relationships with Moffitt Cancer Center and Laxai Avanti Life Sciences, announced this morning, that provide Aptose with technologies for multi-targeting, single agent epigenetic inhibitors."

Corporate Highlights

Earlier on this day, Aptose announced collaborations with Moffitt Cancer Center, a prominent research institute that provides Aptose with exclusive rights to scientifically intriguing multi-targeting epigenetic inhibitors and with Laxai-Avanti Life Sciences, a medicinal chemistry group that will focus on the optimization of preclinical assets with novel epigenetic-based therapies.

Last week, Aptose announced that preclinical data for its lead investigational anticancer therapeutic APTO-253 will be presented at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition by researchers from the Knight Cancer Institute at Oregon Health & Science University (OHSU). Data demonstrate the ability of APTO-253 to kill acute myeloid leukemia (AML) cells in the majority of patient samples, with a trend toward correlation with baseline KLF4 expression level. Moreover, APTO-253 demonstrated enhanced efficacy against AML patient samples when combined with either the BET inhibitor JQ1 or with the FLT3 inhibitor quizartinib.

Financial Results

Net loss for the three months ended September 30, 2015 was $3.3 million ($0.27 per share) compared with $4.2 million ($0.36 per share) during the four months ended September 30, 2014. Net loss for the nine months ended September 30, 2015 was $10.2 million ($0.86 per share) compared with $10.8 million ($1.58 per share) during the ten months ended September 30, 2014.

Aptose utilized cash of $2.6 million in operating activities in the three month period ended September 30, 2015 compared with $3.9 million during the four months ended September 30, 2014. The cash utilized in the three month period ended September 30, 2015 is lower than the four months ended September 30, 2014 due to a lower net loss as well as cash used to reduce accounts payable and accrual balances in the prior year period.

Research and Development

Research and development expenses totaled $1.7 million in the three months ended September 30, 2015 compared to $1.3 million during the four months ended September 30, 2014 and totaled $3.9 million for the nine month period ended September 30, 2015 compared with $2.9 million in the ten months ended September 30, 2014.

Research and development costs in the three months ended September 30, 2015 increased compared with the four months ended September 30, 2014 due to increased APTO-253 development costs including the ongoing Phase 1b clinical trial of APTO-253 in the current year period compared with no ongoing clinical development in the prior year period, including supplementary personnel to support the trial. In addition we have initiated studies to optimize the formulation of APTO-253 for which no comparable work was ongoing in the prior year period.

The increase in research and development costs during the nine months ended September 30, 2015 compared with the ten months ended September 30, 2014 is the result of increased APTO-253 development costs primarily related to the ongoing Phase 1b clinical trial and associated activities including formulation studies and research support. Increased program expenditures were offset by no severance costs in the nine months ended September 30, 2015 compared with $326 thousand in the ten months ended September 30, 2014 related to severance payments made to the former President and COO.

General and Administrative

General and administrative expenses totaled $2.2 million in the three month period ended September 30, 2015 compared to $3.0 million in the four months ended September 30, 2014. For the nine month period ended September 30, 2015, general and administrative expenses were $7.5 million compared with $7.9 million in the ten months ended September 30, 2014.

General and administrative expenses excluding salaries decreased in the three months ended September 30, 2015 compared with the four months ended September 30, 2014. The decrease over the prior year is attributable to a four month reporting period in the prior year compared with a three month reporting period in the current year.

General and administrative expenses excluding salaries were consistent in the nine months ended September 30, 2015 compared with the ten months ended September 30, 2014 despite the shorter time frame in the current year. Comparing on a three month to three month basis, expenses in the current period increased. The increase is attributable primarily to higher insurance and other costs associated with the Aptose’s NASDAQ listing.

Salary charges in the three and nine month periods ended September 30, 2015 were consistent with salary charges in the four and ten month periods ended September 30, 2014 despite the shorter reporting periods in the current year. General and administrative salary costs are primarily incurred in US dollars and the weakening of the Canadian dollar has increased these costs in the current year compared with the prior year.

Stock-based compensation costs were lower in the three months ended September 30, 2015 compared with the four months ended September 30, 2014. This decrease is the result of large option grants in June and July 2014 which vested 50% in the first year and contribute to higher stock-based compensation expense during the first twelve month period.

Stock-based compensation costs were higher in the nine months ended September 30, 2015 compared with the ten months ended September 30, 2014 due to the option grants in June and July 2014 for which 6-7 months of expense were incurred in the current year compared with only 2-3 months of expense in the prior year period.

Deferred share unit costs relate to the marked-to-market adjustment on units which were settled in April 2014. There were no deferred share units outstanding in the nine month period ending September 30, 2015.

Finance Expense

Finance expense for the three months ended September 30, 2015 was $8 thousand compared with $49 thousand for the four months ended September 30, 2014 and $43 thousand for the nine months ended September 30, 2015 compared with $225 thousand for the ten months ended September 30, 2014.

Finance expense for the three and nine months ended September 30, 2015 relates to interest expense of $6 thousand accrued at a rate of 10% on the remaining balance of convertible promissory notes issued in September 2013 as well as accretion expense related to the conversion feature of the notes. All of the promissory notes had been converted into common shares as of September 30, 2015.

Finance expense for the four and ten months ended September 30, 2014 relates to interest accrued at a rate of 10% as well as accretion expense on the $918 thousand promissory notes issued in June 2013 and repaid in April 2014 as well as interest on the convertible promissory notes issued in September 2013 as described above.

Foreign exchange loss is the result of the fluctuation of rates of exchange between US and Canadian dollars.

Finance Income

Finance income totaled $717 thousand in the three months ended September 30, 2015 compared to $161 thousand in the four months ended September 30, 2014 and $1.2 million in the nine months ended September 30, 2015 compared with $235 thousand in the ten months ended September 30, 2014.

Interest income represents interest earned on our cash and cash equivalent and investment balances. Foreign exchange gains are the result of an increase in the value of US dollar denominated cash and cash equivalents balances during the three and nine months ended September 30, 2015 due to a depreciation of the Canadian dollar compared to the US dollar.

On November 10, 2015 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported financial results for the quarter ended September 30, 2015 (Press release, OXiGENE, NOV 10, 2015, View Source [SID:1234508197]).

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For the third quarter of 2015, OXiGENE reported a net loss of $3.6 million compared to a net loss of $3.5 million for the comparable period in 2014. R&D expenses during the third quarter of 2015 were $2.5 million compared to $2.2 million in the third quarter of 2014. General and administrative expenses during the third quarter of 2015 were $1.1 million compared to $1.2 million in the third quarter of 2014.

At September 30, 2015, OXiGENE had cash of $30.3 million, compared to $30.0 million at December 31, 2014.

"We have recently announced encouraging preliminary data for CA4P in both neuroendocrine tumors and recurrent ovarian cancer and have commenced an expanded phase 1b/2 clinical trial of OXi4503 in acute myeloid leukemia," said William D. Schwieterman, M.D., OXiGENE’s President and Chief Executive Officer. "Simultaneously, we are moving forward with the advancement of CA4P in our planned phase 2/3 trials in platinum resistant ovarian cancer and glioblastoma multiforme. I continue to be encouraged by the data supporting the efficacy of our vascular disrupting agents, and I believe the opportunities we have to advance the treatment of cancer are substantial."

On November 10, 2015 Juno Therapeutics, Inc. (NASDAQ:JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported business highlights and financial results for the third quarter of 2015 (Press release, Juno, NOV 10, 2015, View Source;p=RssLanding&cat=news&id=2111192 [SID:1234508194]).

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"We continue to make progress in the clinic and building our capabilities. We began a trial that we expect will support registration of JCAR015 in adult ALL. We started a multi-center Phase I trial for JCAR017 in adult NHL. We completed engineering runs at our manufacturing facility in Bothell. We also continued building out our internal research organization and integrated our two acquisitions," stated Hans Bishop, Juno’s CEO. "Data presented in September suggests that the improved expansion and persistence of JCAR014 lead to clinical benefit. We look forward to presenting more data from our pipeline, in conjunction with our partners, at the upcoming ASH (Free ASH Whitepaper) conference."

Third Quarter 2015 and Recent Corporate Highlights

Clinical Progress:

The U.S. Food and Drug Administration (FDA) cleared Juno’s investigational new drug (IND) application for JCAR015 for the treatment of adult patients with relapsed/refractory (r/r) acute lymphoblastic leukemia (ALL). The Phase 2 study began in the third quarter and will serve as Juno’s U.S. registration trial in adult r/r ALL.

The JCAR017 Phase 1 study in r/r B cell non-Hodgkin lymphoma (NHL) began in the third quarter. The trial is the backbone component of Juno’s multi-pronged strategy in NHL.

The U.S. FDA cleared Juno’s IND application for the MUC-16 & IL-12 "armored" CAR for the treatment of patients with recurrent ovarian cancer.

Corporate News:

Entered into a ten-year collaboration with Celgene to leverage T cell therapeutic strategies with an initial focus on CAR T and TCR therapies. Celgene gained the option to commercialize Juno programs outside North America and co-promote certain programs globally. Celgene also purchased 9.1 million Juno shares. Juno has gained the option to co-develop, co-promote and share profits with respect to select Celgene programs. Juno also received $1.0 billion in total payments, including $150.2 million under the collaboration agreement and $849.8 million in connection with the stock purchase. The collaboration became effective on July 31 after an early termination of the Hart-Scott-Rodino Antitrust waiting period.

Appointed Robert Azelby as Executive Vice President, Chief Commercial Officer. Mr. Azelby is responsible for developing a comprehensive commercial strategy for the company’s product candidates and building the commercial organization.

Third Quarter 2015 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2015 were $1.27 billion compared to $313.4 million at June 30, 2015 and $474.1 million as of December 31, 2014. The Company sold 9,137,672 shares of its common stock to Celgene for $93.00 per share resulting in proceeds of $849.8 million and received a cash payment of $150.2 million in connection with the collaboration agreement.

Cash Burn: Excluding the cash inflow of $1.0 billion received in connection with the Celgene stock purchase and collaboration agreement, cash burn in the three months ended September 30, 2015 was $45.7 million. This included cash paid of $14.2 million primarily related to the build out of the company’s manufacturing facility. The additional burn of $31.5 million was primarily due to cash used in operations related to the overall growth of Juno’s business, including the hiring of key talent. Excluding the cash inflow of $1.0 billion in connection with the Celgene stock purchase and collaboration agreement, cash burn in the nine months ended September 30, 2015 was $206.4 million.

Revenue: Revenue was $1.6 million and $14.1 million in the three and nine months ended September 30, 2015, respectively. The third quarter included $1.3 million recognized in connection with the Celgene collaboration agreement.

R&D Expenses: Research and development expenses in the three and nine months ended September 30, 2015, inclusive of non-cash expenses and computed in accordance with GAAP, were $11.5 million and $129.5 million, respectively, compared to $13.0 million and $22.4 million in the three and nine months ended September 30, 2014, respectively. The decrease of $1.5 million in the three months ended September 30, 2015 compared to the same period in 2014 was primarily due to a decline in the estimated value of the potential success payments to the Fred Hutchinson Cancer Research Center (FHCRC) and Memorial Sloan Kettering Cancer Center (MSK), which resulted in a gain of $25.6 million in the three months ended September 30, 2015, almost completely offset by increased R&D activity. The gain related to the success payments recorded in the three months ended September 30, 2015 was largely due to a decrease in the company’s stock price as of September 30, 2015 compared to June 30, 2015. During the three and nine months ended September 30, 2015, respectively, as compared to the same periods in 2014, Juno experienced increased costs related to expanding the company’s overall research and development capabilities, acquiring external technologies, hiring key talent, advancing programs at its founding institutions, and non-cash stock-based compensation expense. The nine months ended September 30, 2015 included an expense related to the company’s success payments of $17.3 million.

Non-GAAP R&D Expenses: Non-GAAP research and development expenses in the three and nine months ended September 30, 2015 were $35.8 million and $76.6 million, respectively. Non-GAAP research and development expenses in 2015 exclude the following:

A gain of $25.6 million and an expense of $17.3 million for the three and nine months ended September 30, 2015, respectively, associated with the change in estimated value and elapsed accrual period for Juno’s potential success payment liabilities to FHCRC and MSK.

Upfront payments related to license agreements of $30.8 million for the nine months ended September 30, 2015 associated with the Editas and Fate Therapeutics collaborations.

Non-cash stock-based compensation expense of $1.3 million and $4.8 million for the three and nine months ended September 30, 2015, respectively, related to a 2013 restricted stock award to a co-founding director that became a consultant upon his departure from Juno’s board of directors in 2014.

Non-GAAP research and development expenses in the three and nine months ended September 30, 2014 were $11.9 million and $21.0 million, respectively, and exclude success payment expense of $1.1 million and $1.5 million, respectively.

G&A Expenses: General and administrative expenses in the three and nine months ended September 30, 2015, inclusive of non-cash expenses and computed in accordance with GAAP, were $13.6 million and $35.2 million, respectively, compared with $5.4 million and $13.4 million in the three and nine months ended September 30, 2014, respectively. The increase of $8.2 million and $21.8 million in the three and nine months ended September 30, 2015, respectively, was primarily due to increased personnel expenses, including non-cash stock-based compensation expense, costs associated with the Stage, X-Body, Celgene, Fate, and Editas transactions, an increase in patent fees and corporate legal fees, and costs associated with being a public company.
GAAP Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders for the three and nine months ended September 30, 2015 was $23.2 million, or $0.26 per share, and $154.2 million, or $1.80 per share, respectively. This compares to $71.9 million, or $10.50 per share, and $119.0 million, or $17.50 per share, respectively, for the same periods in 2014.

Non-GAAP Net Loss Attributable to Common Stockholders: Non-GAAP net loss attributable to common stockholders, which incorporates the non-GAAP R&D expense, for the three and nine months ended September 30, 2015 was $47.6 million, or $0.53 per share, and $101.2 million, or $1.18 per share, respectively.

For the three and nine months ended September 30, 2014, non-GAAP net loss attributable to common stockholders, which incorporates the non-GAAP R&D expense, was $18.3 million, or $2.68 per share, and $38.5 million, or $5.65 per share, respectively. Non-GAAP net loss attributable to common stockholders for the three and nine months ended September 30, 2014 excludes the following:

Success payment expense of $1.1 million and $1.5 million for the three and nine months ended September 30, 2014, respectively, associated with the change in estimated value and elapsed accrual period for Juno’s potential success payment liabilities to FHCRC and MSK.

Non-cash stock-based compensation expense of $0.4 million and $0.9 million for the three and nine months ended September 30, 2014, respectively, related to a 2013 restricted stock award to a co-founding director that became a consultant upon his departure from Juno’s board of directors in 2014. This expense was classified as general and administrative expense in the three and nine months September 30, 2014 due to the nature of the work performed during this time.

Non-cash convertible preferred stock option expense of $10.7 million in the nine months ended September 30, 2014.

A non-cash charge of $52.1 million and $67.5 million for the three and nine months ended September 30, 2014 related to deemed dividends upon issuance of convertible preferred stock.

A reconciliation of GAAP net loss to non-GAAP net loss is presented below under "Non-GAAP Financial Measures."

2015 Financial Guidance
Juno continues to expect 2015 cash burn, excluding cash inflows or outflows from business development activities and litigation, to be at the higher end of its guidance of between $125 million and $150 million.

On November 10, 2015 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the third quarter 2015 (Press release, ImmunoCellular Therapeutics, NOV 10, 2015, View Source [SID:1234508193]).

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Andrew Gengos, ImmunoCellular Chief Executive Officer, commented: "With the many milestones we achieved in the third quarter, and throughout this year, we believe that we have changed the trajectory and reshaped the future of ImmunoCellular, and made significant advances toward our goal of becoming a leading cancer immunotherapy company. The highlights of the quarter include reaching agreement with the FDA on the Special Protocol Assessment for the ICT-107 registrational trial in patients with newly diagnosed glioblastoma, and receiving the almost $20 million award from the California Institute for Regenerative Medicine (CIRM) to support the program. We are on the cusp of achieving a major milestone with the start of our Company’s first registrational phase 3 program, anticipated to be initiated this month. We also look forward to presenting updated ICT-107 phase 2 trial results at the Society for Neuro-Oncology (SNO) meeting on November 20th. We remain on track to achieve our goals this year, underscoring our confidence that 2015 is a year of meaningful growth, transition and value creation for our company."

For the quarter ended September 30, 2015, the Company reported a net loss of $3.4 million, or $0.04 per basic and diluted share, compared to a net loss of $1.9 million, or $0.03 per basic and diluted share for the quarter ended September 30, 2014. During the quarter ended September 30, 2015, the Company incurred $2.6 million in research and development expenses compared to $1.5 million in the same quarter of 2014. The increase reflects costs related to the ramp-up of the phase 3 trial of ICT-107, patient enrollment in the ICT-121 phase 1 trial and ramp-up of expenses related to the Company’s Stem-to-T-cell program. These expenses were partially offset by reductions in the ICT-107 phase 2 trial, which continued to wind down, and suspension of the Company’s ICT-140 ovarian cancer program.

For the nine months ended September 30, 2015, the Company reported a net loss of $8.0 million, or $0.09 per basic and diluted share, compared to $7.3 million, or $0.12 per basic and diluted share during the same period in 2014. During the nine months ended September 30, 2015, the Company incurred additional research and development expenses. Also, during the nine months ended September 30, 2015, the Company recorded a gain of $2.3 million related to a reduction in the valuation of its derivative warrants compared to a gain of $400,000 in the same period of 2014.

The Company reported that cash used in operations during the nine months ended September 30, 2015 was $13.2 million compared to $7.8 million during the same period of 2014. The increase in cash used in operations primarily reflects additional research and development expenses and also reflects $4.0 million of vendor deposits related to the ICT-107 Phase 3 trial. These deposits will be offset against future amounts owed to these vendors. Other expenses were consistent between periods. The Company expects that research and development expenses will continue to increase in future periods as it prepares for the phase 3 trial of ICT-107 and as it expands its Stem-to-T-cell program.

On September 18, 2015 the Company received an award in the amount of $19.9 million from CIRM to partially fund the Company’s phase 3 trial of ICT-107. Under the terms of the CIRM award, the Company is obligated to share future ICT-107 related revenue with CIRM. Alternatively, the Company may convert the award to a loan. Since the Company may be required to repay some or all of the amounts awarded by CIRM, the Company plans to account for this award as a liability rather than as revenue.

As of September 30, 2015, the Company had $24.4 million in cash and cash equivalents.