Uncategorized – Page 16338 – 1stOncology™: Cancer Intelligence Service

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, GlobeImmune, AUG 13, 2015, View Source [SID:1234507252])

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OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Second Quarter 2015

On August 13, 2015 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported second quarter 2015 financial results (Press release, OncoGenex Pharmaceuticals, AUG 13, 2015, View Source [SID:1234507254]).

Recent Developments and Anticipated Near-term Milestones

Custirsen – Phase 3 Lung and Prostate Cancer Trials

On July 13, 2015, the company announced that its Phase 3 ENSPIRIT trial evaluating custirsen for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) is continuing as planned per the recommendation of an Independent Data Monitoring Committee (IDMC). This decision was based upon completion of the second and final planned interim futility analysis that included a more rigorous evaluation for determining futility in achieving a survival benefit associated with custirsen in NSCLC. Based on current enrollment projections, the company believes final survival results could be available in the second half of 2016.

On June 10, 2015, OncoGenex announced that the U.S. Food and Drug Administration (FDA) has agreed to the company’s proposed amendment to the Phase 3 AFFINITY protocol and statistical analysis plan. The proposed amendment includes the addition of a co-primary survival objective designed to prospectively evaluate the survival benefit of custirsen in men who are at increased risk for poor outcomes when treated with cabazitaxel for metastatic castrate-resistant prostate cancer (CRPC). Patients at risk for poor outcomes will be identified as having two or more of five common risk factors. In addition, OncoGenex and the FDA agreed that an interim analysis will occur for the entire study population when the final analysis for the poor prognosis subpopulation occurs. Advice from the European Medicines Agency through its Scientific Review process will be completed prior to finalizing the protocol amendment. Subject to finalizing the pending protocol amendment, timing for the final analysis of the poor prognosis subpopulation is projected to occur by the end of 2015, while the final analysis for the entire study population is projected to occur in the second half of 2016.

On May 30, 2015, the company announced that results from a retrospective analysis of the Phase 3 SYNERGY trial showed a benefit with custirsen therapy in men with metastatic CRPC who were at risk for poor outcomes. The analysis, exploring the effect of clusterin inhibition in men at risk for poor outcomes, showed that over 40% of men in the trial had at least two of five common risk factors for poor prognosis. In these men, the analysis found a 27% lower risk of death when custirsen was used in combination with first-line docetaxel compared to docetaxel alone. These results were presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago.

Apatorsen – Phase 2 Bladder, Lung, Pancreatic and Prostate Cancer Trials

Investigators from the Phase 2 Borealis-1 trial presented results from an exploratory analysis that showed metastatic bladder cancer patients with poor prognostic features (KPS, liver involvement, low hemoglobin and high alkaline phosphatase) benefited from apatorsen 600mg added to first-line chemotherapy (OS HR = 0.72) compared to chemotherapy alone. Patients in the trial with a Karnofsky Performance Status (KPS) of 80% or less, a common indicator of poor prognosis, experienced a 50% reduction in risk of death with the addition of apatorsen therapy (OS HR = 0.50). These results were presented in an oral session on June 1, 2015 at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago.

"This is an exciting time for the company with multiple anticipated upcoming clinical milestones through 2015 and into 2016, including a Phase 3 data readout expected by the end of the year," said Scott Cormack, President and CEO of OncoGenex. "Our two priority assets – custirsen and apatorsen – continue to demonstrate their potential value to provide clinical benefit in the most vulnerable patients – those at increased risk for poor outcomes and/or more resistant disease."

Financial Update and Results

Revenue for the three and six months ended June 30, 2015 decreased to $4.0 million and $5.4 million, respectively, from $4.9 million and $16.7 million for the three and six months ended June 30, 2014, respectively.

Total operating expenses for the three and six months ended June 30, 2015 were $9.6 million and $16.0 million, respectively, compared to $12.6 million and $32.2 million for the three and six months ended June 30, 2014, respectively.

Net loss for the three and six months ended June 30, 2015 was $6.0 million, or $0.26 per dilluted common share, and $10.5 million, or $0.46 per dilluted common share, respectively, compared with $7.0 million, or $0.47 per diluted common share, and $15.7 million, or $1.05 per dilluted common share, respectively, for the three and six months ended June 30, 2014.

As of June 30, 2015, cash, cash equivalents and short-term investments increased to $60.2 million from $47.1 million as of December 31, 2014.

Subsequent to June 30, 2015, the company raised $14.7 million from the sale of common stock to Lincoln Park Capital, LLC under the terms of the share purchase agreement. As of August 13, 2015, no further amounts remained available for sale under this offering program.

Based on current expectations, the company believes that these resources, in addition to the amounts received from the sale of common stock to Lincoln Park Capital, LLC in the third quarter of 2015 will be sufficient to fund its currently planned operations late into the fourth quarter of 2016, which may include:

announcement of final results of the poor prognosis subpopulation in the Phase 3 AFFINITY prostate cancer trial by the end of 2015 and final analysis for the entire study population in the second half of 2016, depending on timing of the event-driven final analysis and subject to completion and submission of the proposed protocol amendment;

announcement of final survival results in the Phase 3 ENSPIRIT lung cancer trial expected in the second half of 2016;

completion of enrollment in the Phase 2 Borealis-2 bladder cancer trial expected to occur in the third quarter of 2015;

announcement of the Phase 2 Rainier pancreatic cancer trial results expected by the end of 2015;

announcement of the Phase 2 Spruce lung cancer trial results expected in the first half of 2016;

announcement of the Phase 2 Pacific prostate cancer trial preliminary results expected in 2016; and
completion of enrollment in the Phase 2 Cedar lung cancer trial expected in 2016.
As of August 13, 2015, OncoGenex had 29,791,776 shares outstanding.

Immune Design Reports Second Quarter 2015 Financial Results

On August 12, 2015 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the second quarter ended June 30, 2015, which included the announcement of three new immuno-oncology clinical collaborations and a cash position of $129.0 million, inclusive of net proceeds from a public offering in April 2015 (Press release, Immune Design, AUG 12, 2015, View Source [SID:1234507218]).

Corporate Update and Recent Highlights
On August 10, 2015, Immune Design reported it had entered into two clinical trial collaborations with Merck (NYSE:MRK) to evaluate two immuno-oncology investigational agents, G100 and LV305, each separately combined with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1therapy, in Phase 1 trials in patients with non-Hodgkin’s lymphoma (NHL) and melanoma, respectively.

Earlier today, Immune Design announced it had entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate the safety and efficacy of Immune Design’s CMB305 prime-boost immuno-oncology investigational agent combined with the investigational cancer immunotherapy, atezolizumab (MPDL3280A; anti-PD-L1), in a randomized Phase 2 trial in patients with soft tissue sarcoma.

In May 2015, Immune Design announced the presentation of positive clinical data from three immuno-oncology Phase 1 studies at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The three trials provide first-in-human clinical data with the company’s immuno-oncology agents that are designed to generate anti-tumor immunity, LV305 and G305 which target the tumor-associated antigen, NY-ESO-1 and are the two components of CMB305 and G100, which in contrast, is a potent toll-like receptor-4 (TLR4) agonist that is being administered intratumorally to activate local and systemic immunity.

In April 2015, Immune Design closed an underwritten public offering of 3,000,000 shares of common stock at a price of $26.50 per share. In May 2015, the company sold an additional 47,409 shares when the underwriters exercised a portion of their overallotment option. Immune Design received aggregate net proceeds of $75.4 million, after underwriting discounts and commissions and offering expenses totaling $5.4 million.

Financial Results and Guidance

Second Quarter

Immune Design ended the second quarter of 2015 with $129.0 million in cash and cash equivalents, compared to $75.4 million as of December 31, 2014.

Net loss and net loss per share for the second quarter of 2015 were $10.5 million and $0.54, respectively, compared to $6.1 million and $16.57, respectively, for the second quarter of 2014.

Revenue for the second quarter of 2015 was $1.8 million and was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014. Revenue for the second quarter of 2014 was $1.1 million and related primarily to license revenue associated with the company’s collaboration with MedImmune.

Research and development expenses for the second quarter of 2015 were $8.5 million, compared to $3.9 million for the second quarter of 2014. The $4.6 million increase was primarily attributable to contract manufacturing and clinical trials for LV305 and CMB305, as well as activities related to the company’s HSV-2 collaboration with Sanofi Pasteur. Expenses incurred under the collaboration are predominantly reimbursed by Sanofi Pasteur and reflected in revenue. Additionally, there was an increase in personnel-related expenses, including stock-based compensation, as a result of growth in research and development headcount to support Immune Design’s advancing research and clinical pipeline. Research and development stock-based compensation (a non-cash expense), was $0.5 million for the current quarter compared to $0.1 million for the same quarter in 2014.

General and administrative expenses for the second quarter of 2015 were $3.8 million, compared to $1.9 million for the second quarter of 2014. The $1.9 million increase was primarily attributable to increases in personnel-related expenses, including stock based compensation, primarily related to an increase in administrative headcount to support the growth and expansion of the business. General and administrative expenses for stock-based compensation (a non-cash expense), was $1.3 million for the current quarter compared to $0.1 million for the same quarter in 2014.

Year-to-Date

Net operating cash used in operations through June 2015 was $21.7 million, which excludes the $75.4 million in net proceeds received from the company’s follow-on offering.

Net loss and net loss per share for the six months ended June 30, 2015 were $19.9 million and $1.10, respectively, compared to $14.3 million and $38.81, respectively, for the same period in 2014.

Revenue for the six months ended June 30, 2015 was $3.7 million and was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014. Revenue for the same period in 2014 was $1.1 million related primarily to Immune Design’s collaboration with MedImmune.

Total operating expenses for the six months ended June 30, 2015 were $23.6 million, compared to $11.3 million for the same period in 2014. The increase in the current period relates primarily to contract manufacturing and clinical trials for LV305 and CMB305, as well as activities related to the company’s HSV-2 collaboration with Sanofi Pasteur. Expenses incurred under the collaboration are predominantly reimbursed by Sanofi Pasteur and reflected in revenue. Additionally, there was an increase in personnel-related expenses, including stock based compensation, as a result of growth and expansion of the business following Immune Design’s initial public offering in July 2014, in professional service fees and legal fees to support operations as a public company and to defend ongoing litigation, and in facility and office costs.

Updated Financial Guidance

In consideration of the funds raised through Immune Design’s follow-on equity offering in April 2015 and investment in the company’s clinical development pipeline, revised 2015 financial guidance is as follows:

Anticipate ending fiscal 2015 with a cash and investments balance of at least $110.0 million.
Estimate net cash used in operating activities of $36.0 to $40.0 million for the year-ending December 31, 2015. This is an increase from beginning of the year guidance, which was an estimated range of $33.0 to $37.0 for net cash used in operating activities.

8-K – Current report

On August 11, 2015 Bio-Path Holdings, Inc., (NASDAQ: BPTH) ("Bio-Path"), a biotechnology company leveraging its proprietary liposomal delivery technology to develop a portfolio of targeted nucleic acid cancer drugs, reported operational and financial results for the quarter ended June 30, 2015 (Filing, 8-K, Bio-Path Holdings, AUG 12, 2015, View Source [SID:1234507219]).

SECOND QUARTER 2015 AND RECENT OPERATIONAL AND FINANCIAL HIGHLIGHTS

o The data package for the monotherapy portion of the Phase 1 clinical trial of Bio-Path’s lead compound, Liposomal Grb-2 ("BP-1001"), in blood cancers was finalized during the quarter. Liposomal Grb-2 was well tolerated with the drug showing signs of anti-leukemia activity and no drug related toxicities. Among 21 evaluable patients, more than half experienced at least a fifty percent (50%) reduction in peripheral or bone marrow blasts from baseline. Additionally, several patients demonstrated transient improvement and/or stable disease. Notably, one patient with Chronic Myelogenous Leukemia (CML) blast phase showed a significant reduction in blasts. The patient data from the Phase I clinical trial also demonstrated significant reductions in the target Grb-2 protein and its downstream proteins, providing positive evidence that Bio-Path’s DNAbilizeTM neutral lipid delivery with proprietary antisense technology successfully delivers an antisense drug substance to a diseased cell to knock down the target protein, which is an industry-first for antisense systemic therapeutics.

o Enrollment continues into the safety portion of the Phase 2 combination trial evaluating Liposomal Grb-2 and low dose Ara-C frontline therapy in patients with Acute Myeloid Leukemia (AML). The safety portion of the Phase 2 trial is designed to assess two cohorts with three patients each: 60 mg/m2 of Liposomal Grb-2 and frontline Ara-C and 90 mg/m2 of Liposomal Grb-2 and frontline Ara-C in its intended use in combination with an existing chemotherapeutic agent. Bio-Path expects this portion of the program will be completed in the second half of 2015.

The Phase 2 combination trial will target older AML patients who are unfit for intense treatment. The average age of diagnosis for AML is 66 years old. However, older patients do not tolerate intense chemotherapy well and treatment related mortality is a major concern among AML patients greater than 65 years old, representing approximately sixty percent (60%) of AML patients. This patient segment represents an unmet need for an approach that provides quality of life and provides an excellent opportunity for clinical development of Liposomal Grb-2.

o An abstract has been submitted by Jorge Cortes, M.D., Professor and Deputy Chair, Department of Leukemia, The University of Texas MD Anderson Cancer Center (MD Anderson Cancer Center) and staff for presentation of the specific data from the Phase 1 clinical trial monotherapy testing of Liposomal Grb-2, which is planned to be reviewed at the Annual Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December. In addition, the available data from the safety portion of the Phase 2 trial combination therapy evaluating Liposomal Grb-2 and low dose Ara-C frontline therapy in patients with AML is also to be included in the data package for presentation at the ASH (Free ASH Whitepaper) meeting.

o Bio-Path commenced development during the quarter of a protocol for a Phase 2 clinical trial evaluating Liposomal Grb-2 and frontline therapy in patients with CML in blast crisis, which is an unmet need. The Company expects to complete preparations to initiate the toxicity portion of this Phase 2 trial by the end of 2015.

o Product candidate vetting and development continued during the quarter to support efforts to broaden the Company’s product pipeline. These product candidates include opportunities in the cancer area as well as candidates outside of cancer such as autoimmune disease.

o Preclinical testing of its lead product candidate, Liposomal Grb-2, is continuing, into two additional indications: triple negative breast cancer (TNBC) and inflammatory breast cancer (IBC), two cancers characterized by the formation of aggressive tumors and relatively high mortality rates. The Company is working in collaboration with a leading researcher working in the The University of Texas MD Anderson Cancer Center (MD Anderson) breast cancer program. The Company completed testing of a monotherapy in vivo segment of the preclinical program and is evaluating the results. The preclinical program may be expanded to include a combination therapy evaluation.

o Bio-Path has retained a public relations firm specializing in biotech and large pharmaceutical company public relations. Key among the goals will be increasing industry and investor awareness of Bio-Path’s DNAbilizeTM neutral lipid delivery of p-ethoxy antisense technology and Bio-Path as a multi-product candidate company.

o Bio-Path established an "at-the-market" ("ATM") program during the quarter through which it may offer and sell up to $25 million of common stock from time to time, at Bio-Path’s discretion, through an investment banker, acting as sales agent. Sales of Bio-Path common stock under the ATM program may be made directly on or through the Nasdaq Capital Market, among other methods.

· Second Quarter 2015 Financial Highlights

o The Company reported a net loss of $1.1 million for the three months ended June 30, 2015, compared to a net loss of $1.3 million for the three months ended June 30, 2014. The decrease was primarily due to decreased management and administrative personnel costs. The Company reported a net loss per share of $0.01 for both the three months ended June 30, 2015 and June 30, 2014. Net loss for the six months ended June 30, 2015 was $2.5 million, or $0.03 per share, compared to a net loss of $1.8 million, or $0.02 per share, for the six months ended June 30, 2014. The increase was primarily due to increased manufacturing development and preclinical study costs as well as personnel costs associated with the addition of research and development support staff in the latter half of 2014.

o Research and development expenses for the three months ended June 30, 2015 increased to $0.6 million compared to $0.5 million for the three months ended June 30, 2014. For the six months ended June 30, 2015, research and development expenses increased to $1.2 million compared to $0.6 million for the six months ended June 30, 2014.

o General and administrative expenses for the three months ended June 30, 2015 decreased to $0.6 million compared to $0.8 million for the three months ended June 30, 2014. For the six months ended June 30, 2015, general and administrative expenses increased to $1.4 million compared to $1.1 million for the six months ended June 30, 2014.

o As of June 30, 2015, the Company had cash of $11.1 million, compared to $13.9 million at December 31, 2014. Net cash used in operating activities for the six months ended June 30, 2015 was $2.8 million compared to $1.6 million for the comparable period in 2014.

"Completion of the data package for the monotherapy portion of the Phase 1 trial of Liposomal Grb-2 in blood cancers was a significant milestone in wrapping up that portion of the trial," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "The data demonstrates that Liposomal Grb-2 is a targeted therapy treatment that does not have treatment side effects, which greatly enhances its potential for combination therapy with other frontline treatments. The safety portion of our Phase 2 combination therapy trial is gaining momentum. The submission of the abstract to the ASH (Free ASH Whitepaper) meeting for a presentation of both the monotherapy portion of the Phase 1 plus the early cohorts from the Phase 2 combination therapy trial presents an early opportunity to highlight the potential of Liposomal Grb-2 combination therapy with Ara-C to treat an important, unmet need of the AML population. We believe development of Liposomal Grb-2 with AML fragile patient population is an exciting development opportunity. We continue to make significant progress in building a solid pipeline of cancer therapies, which is a key goal for Bio-Path. We recently initiated plans and development for a Phase 2 trial of Liposomal Grb-2 combination therapy in CML blast crisis patients. This is another unmet patient area with a high priority. Preparation of the Liposomal Bcl-2 package to initiate a trial in follicular lymphoma is also on track. Development of our preclinical pipeline has increased, adding product candidate opportunities outside of cancer that could benefit from our unique delivery technology."

Mr. Nielsen continued, "Operationally, the retention of a top firm to work with Bio-Path to build and implement a comprehensive public relations program is an important corporate development step. Bio-Path’s technology, clinical development and organization have progressed far enough now that we expect this be a very effective communications and media program. Our balance sheet continues to be strong, with sufficient cash to continue our development programs through 2015 and into 2016. In addition, the establishment of a $25 million ATM financing program provides us the ability to raise additional capital in the short term if needed."

About Bio-Path’s Delivery Technology

Bio-Path’s drug delivery technology involves microscopic-sized liposome particles that distribute nucleic acid drugs systemically and safely throughout the human body, via simple intravenous infusion. The delivery technology is applied to proprietary, single stranded (antisense) nucleic acid compounds with the potential to revolutionize the treatment of cancer and other diseases where drugable targets of disease are well characterized. The Company is currently focused on developing liposomal antisense drug candidates. Bio-Path also anticipates developing liposome tumor targeting technology, representing next-generation enhancements to the Company’s core liposome delivery technology.

About Growth Receptor Bound protein-2 (Grb-2)

The adaptor protein Growth Receptor Bound protein-2 (Grb-2) is essential to cancer cell signaling because it is utilized by oncogenic tyrosine kinases to induce cancer progression. Suppressing the function or expression of Grb-2 should interrupt its vital signaling function and have a therapeutic application in cancer. BP-1001 is a neutral-charge, liposome-incorporated antisense drug substance designed to inhibit Grb-2 expression.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Soligenix, AUG 12, 2015, View Source [SID:1234507216])

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Category: Uncategorized

10-Q – Quarterly report [Sections 13 or 15(d)]

OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Second Quarter 2015

Immune Design Reports Second Quarter 2015 Financial Results

8-K – Current report

10-Q – Quarterly report [Sections 13 or 15(d)]