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 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 (Press release, Aptose Biosciences, NOV 10, 2015, View Source;p=RssLanding&cat=news&id=2111201 [SID:1234508461]). 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.

Components of research and development expenses:

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 consist of the following:

Components of general and administrative expenses:

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 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported financial results for the third quarter ended September 30, 2015 and provided an update on its pipeline (Press release, Loxo Oncology, NOV 10, 2015, View Source [SID:1234508164]). Loxo Oncology will not be conducting a conference call in conjunction with this earnings release.

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"In the third quarter we made tremendous progress with LOXO-101, executing ahead of plan," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "Our Phase 1 trial continues to mature nicely, and we were able to open our Phase 2 trial approximately six months early. Additionally, we were proud to report that the National Cancer Institute selected LOXO-101 as the preferred and sole TRK inhibitor for relevant patients in the NCI-MATCH trial. I think we can attribute much of this success to the compelling efficacy and tolerability signals seen in Phase 1, and a growing appreciation for the diversity of TRK fusion biology across human cancer in the scientific and molecular diagnostic communities."

Program Updates

Loxo Oncology provided the following updates on its development programs:

LOXO-101: the only potent, oral, selective inhibitor of the tropomyosin receptor kinase (TRK) family of proteins in clinical development

LOXO-101 Phase 2 Trial Initiated

Loxo Oncology enrolled the first patient in its Phase 2 trial of LOXO-101, a global, multi-center, single-arm, open-label basket trial in approximately up to 150 adult patients with solid tumors that harbor a TRK fusion, as determined by any Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited test. Patients with TRK fusions will be enrolled into one of eight cohorts: non-small cell lung cancer, thyroid cancer, sarcoma, colorectal cancer, salivary gland cancer, biliary cancer, primary central nervous system tumors and all other solid tumor histologies.

LOXO-101 Phase 1 Data Presented at EORTC

New results from the ongoing dose-escalation Phase 1 study of LOXO-101 in patients with solid tumors refractory to standard therapy were reported in a late-breaking oral presentation at the 27th AACR (Free AACR Whitepaper)-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics.

As of the October 20, 2015 data cutoff date, 30 patients had been enrolled and treated, including six patients with cancers harboring TRK fusions. Three of the six patients with TRK fusion cancers had been on study sufficiently long for their first efficacy assessment, and all three had achieved an objective response at the first response assessment, as defined by standard RECIST criteria. All three of these patients remain in response and on study. The other three patients with TRK fusion cancers were recently enrolled and thus had not yet been evaluated for response as of the data cutoff date, though they all remain on study.
LOXO-101 has been well tolerated, including the 100 mg twice-daily dose, which has been selected for Phase 2 study and has shown efficacy in TRK fusion patients. The majority of adverse events reported by investigators have been mild to moderate. A maximum tolerated dose (MTD) has not been defined, though near-term Phase 1 enrollment will focus on further characterizing the pharmacokinetics and safety of the 100 mg twice-daily dose dosing. The data presentation from the meeting can be accessed here View Source

LOXO-101 Selected for NCI-MATCH Trial

The independent committee of the National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) clinical trial chose LOXO-101 as the sole, dedicated treatment arm for patients with TRK gene fusions.

The NCI-MATCH trial will initially enroll 3,000 patients with tumor biopsies available for comprehensive genomic profiling and assign these patients to an appropriate targeted therapy arm based on the molecular abnormalities of each tumor. Over 700 trial sites in 48 states in the United States are currently open for enrollment.

LOXO-101 Granted Orphan Drug Designation

The United States Food and Drug Administration (FDA) granted Loxo Oncology orphan drug designation for LOXO-101 for treatment of patients with soft tissue sarcoma.

Pre-clinical Programs

Data on RET and FGFR Programs Presented at AACR (Free AACR Whitepaper)-NCI-EORTC

Loxo presented two preclinical posters at AACR (Free AACR Whitepaper)-NCI-EORTC containing the first publicly disclosed data for its Rearranged during Transfection (RET) and Fibroblast Growth Factor Receptor (FGFR) programs.

Loxo Oncology’s novel, potent and selective RET inhibitor demonstrated potent inhibition of RET in enzyme and cellular assays with minimal activity against highly related kinases in animal models. The company is on track to initiate a Phase 1 study of its RET inhibitor in late 2016 or early 2017.

Data for the company’s potent and selective FGFR inhibitor show that it spared FGFR1 and other related kinases and possesses high oral bioavailability and favorable PK properties in animal models.

Third Quarter 2015 Financial Results

As of September 30, 2015 Loxo had aggregate cash, cash equivalents and investments of $93.4 million, compared to $112.9 million as of December 31, 2014.

The company continues to expect cash burn of $30-$33 million in 2015, and based on the current operating plan, the company believes existing capital resources will be sufficient to fund anticipated operations into 2017.

Research and development expenses were $6.3 million for the third quarter 2015 compared to $5.1 million for the third quarter 2014. The increase was primarily due to expanded Phase 1 and Phase 2 clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma. The company also recognized R&D-related stock-based compensation expense of $0.5 million during the third quarter of 2015 compared to $1.7 million for the third quarter of 2014.

Research and development expenses were $15.8 million for the nine months ended September 30, 2015 compared to $9.9 million for the nine months ended September 30, 2014. The increase was primarily due to expanded Phase 1 and Phase 2 clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma. The company also recognized R&D-related stock-based compensation expense of $1.8 million during the nine months ended September 30, 2015 compared to $2.0 million for the nine months ended September 30, 2014.

General and administrative expenses were $2.6 million for the third quarter 2015 compared to $1.6 million for the third quarter 2014. The increase was primarily due to additional full-time equivalents, increased compensation costs and increased costs associated with operating as a public company. The company also recognized G&A-related stock-based compensation expense of $0.7 million during the third quarter of 2015 compared to $0.3 million for the third quarter of 2014.

General and administrative expenses were $7.3 million for the nine months ended September 30, 2015 compared to $3.6 million for the nine months ended September 30, 2014. The increase was primarily due to additional full-time equivalents, increased compensation costs and increased costs associated with operating as a public company. The company also recognized G&A-related stock-based compensation expense of $2.0 million during the nine months ended September 30, 2015 compared to $0.5 million for the nine months ended September 30, 2014.

Net loss attributable to common stockholders was $8.8 million and $23.0 million for the three and nine months ended September 30, 2015, respectively, compared to $6.7 million and $13.6 million for the three and nine months ended September 30, 2014, respectively.

About LOXO-101

LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions. For additional information about both the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.

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 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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