On November 13, 2015 KaloBios Pharmaceuticals, Inc. (Nasdaq:KBIO) reported that it will wind down its operations and that it has engaged the Brenner Group to lead those efforts (Press release, KaloBios, NOV 13, 2015, View Source [SID:1234509374]).

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"Recent discussions around a number of possible strategic transactions have ended, and as a result, the company believes it is highly unlikely that continuing to explore strategic alternatives could generate a viable transaction within the time frame allowed by our limited cash resources," said Herb Cross, Chief Financial Officer and Interim Chief Executive Officer.

The company will discontinue its two current development programs, KB004, being studied in Phase 2 for certain hematologic malignancies, and lenzilumab, or KB003, scheduled to initiate Phase I development later this year in chronic myelomonocytic leukemia (CMML). KaloBios has engaged the restructuring firm of The Brenner Group to assist in the wind down of operations and liquidation of the company’s assets. The company recently announced a reduction in operations and headcount affecting approximately 60% of the company’s 28 employees. As a part of its wind down and handing over management of the wind down to The Brenner Group, the company expects to phase out the remaining employees over the next thirty to sixty days. As a result of these developments, the company will not be able to file its Form 10-Q for the third quarter, primarily due to resource constraints.

As a part of its restructuring and winding down, the company has repaid in full its outstanding secured loan obligation to MidCap Financial, secured lender to the company, in the approximate amount of $6.6 million.

(Filing, 10-Q, Onconova, NOV 12, 2015, View Source [SID:1234508225])

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On November 12, 2015 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported financial results for the quarter ended September 30, 2015 (Press release, Kite Pharma, NOV 12, 2015, View Source [SID:1234508221]).

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"Over the past few months, we have achieved many significant corporate and clinical development milestones, including the initiation of two pivotal Phase 2 studies of our lead product candidate, KTE-C19," noted Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "Our ZUMA-1 trial is enrolling patients with aggressive, refractory non-Hodgkin’s lymphoma, while our ZUMA-2 trial is enrolling patients with relapsed or refractory mantle cell lymphoma. We also plan to initiate two additional pivotal studies of KTE-C19 in patients with acute lymphoblastic leukemia prior to the end of this year. We look forward to reporting data from these trials in 2016 with the goal of filing our first Biologics License Application by the end of 2016."

Recent Highlights

Completed the Phase 1 portion of the KTE-C19 study in aggressive, refractory non-Hodgkin’s lymphoma (NHL) and recently opened enrollment in the pivotal Phase 2 (ZUMA-1) multi-center trial to support registration and potential commercial launch of KTE-C19 in 2017.

Initiated the second pivotal Phase 2 KTE-C19 study (ZUMA-2) in patients with relapsed or refractory mantle cell lymphoma (MCL) to support registration in this indication.

Obtained Orphan Drug Designations in the EU for KTE-C19 in leading hematological malignancies including designation for the treatment of primary mediastinal B-cell lymphoma, MCL, chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, and acute lymphoblastic leukemia (ALL).

Four abstracts were accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, including an abstract on the safety and efficacy data from the Company’s KTE-C19 Phase 1 study in patients with aggressive, refractory NHL.

Expanded our collaboration with the Netherlands Cancer Institute for an exclusive option to license multiple T cell receptor (TCR) gene sequences for the development and commercialization of immunotherapy candidates targeting solid tumors.

Secured an exclusive, worldwide license with the National Institutes of Health to IP related to TCR-based product candidates that target MAGE A3 and A3/A6 antigens.

Secured an exclusive license to Alpine Immune Sciences’ transmembrane immunomodulatory protein (TIP) technology for chimeric antigen receptor and TCR-based products.

Appointed Dr. Franz B. Humer, former Chairman and Chief Executive of Roche Holding Ltd., to our Board of Directors.
Strengthened our Scientific Advisory Board with the addition of Drs. James Allison and Padmanee Sharma, recognized leaders from MD Anderson Cancer Center.

Held the official inauguration for Kite EU, our European headquarters in Amsterdam.
Completed construction of our clinical supply manufacturing facility in Santa Monica.

Third Quarter 2015 Financial Results

Cash Position: As of September 30, 2015, Kite had $368.6 million in cash, cash equivalents, and marketable securities, compared to $367.0 million as of December 31, 2014.

Cash Burn: Cash burn was $24.3 million for the third quarter of 2015, compared to $8.0 million for the third quarter of 2014. This increase was primarily due to the ramp up of our operations supporting the KTE-C19 program, including costs to build out our clinical manufacturing and commercial manufacturing facilities.

Net Loss: GAAP net loss attributable to common stockholders was $27.4 million, or $0.63 per share, for the third quarter of 2015, compared to $9.1 million, or $0.24 per share, for the third quarter of 2014. Non-GAAP net loss attributable to common stockholders for the third quarter of 2015 was $16.6 million, or $0.38 per share. Non-GAAP net loss for the third quarter of 2015 excludes non-cash stock-based compensation expense of $10.8 million for the third quarter of 2015. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net loss to non-GAAP net loss.

Revenue: Revenue was $5.1 million for the third quarter of 2015 compared to $0 for the third quarter of 2014. The increase was primarily due to revenue recognized under the Amgen collaboration.

Total Operating Expenses: Total GAAP operating expenses for the third quarter of 2015 were $32.9 million, compared to $9.1 million for the third quarter of 2014.

R&D Expenses: GAAP research and development (R&D) expenses were $21.7 million for the third quarter of 2015, compared to $5.7 million for the third quarter of 2014, an increase of $16.0 million. This increase was primarily attributable to a $9.1 million increase in research and clinical development expenses supporting the advancement of our KTE-C19 studies and our additional development programs, $3.2 million in expenses related to increased personnel and consulting costs, and $3.7 million of non-cash stock-based compensation expense.

G&A Expenses: GAAP general and administrative (G&A) expenses were $11.1 million for the third quarter of 2015, compared to $3.4 million for the third quarter of 2014, an increase of $7.7 million. This increase was primarily attributable to a $3.0 million increase in personnel related expenses, $0.9 million for license obligations, and $3.8 million of non-cash stock-based compensation.

2015 Financial Guidance: Kite’s guidance remains unchanged. Kite expects to burn between $100 million and $125 million in cash for the full year 2015, which includes both operating expenses and capital expenditures. This guidance does not include cash inflows or outflows for business development activities.

(Filing, 10-Q, OXiGENE, NOV 12, 2015, View Source [SID:1234508226])

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On November 12, 2015 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported third quarter 2015 financial results and provided a summary of clinical developments and anticipated milestones (Press release, OncoGenex Pharmaceuticals, NOV 12, 2015, View Source [SID:1234508223]).

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Clinical Developments and Anticipated Near-term Milestones

Custirsen – Phase 3 Prostate Cancer Trials

On September 27, 2015, OncoGenex announced results from additional exploratory analyses of the Phase 3 SYNERGY trial demonstrating that custirsen treatment significantly lowered serum clusterin (sCLU) levels from baseline in men with metastatic castrate-resistant prostate cancer (mCRPC). In addition, these data presented at the 2015 European Cancer Congress (ECC 2015) in Vienna showed that sCLU reductions after custirsen treatment resulted in higher two-year survival rates in patients who were at increased risk for poor outcomes. Of those patients with lower sCLU levels, the data also showed a correlation to an overall survival benefit for custirsen-treated patients who were at increased risk for poor outcomes.

On October 8, 2015, OncoGenex announced that the European Medicines Agency (EMA) completed its review of the proposed amendment to the company’s Phase 3 AFFINITY protocol and statistical analysis plan. Both the U.S. Food and Drug Administration (FDA) and the EMA have now completed their reviews and are supportive of the proposed amendment to the AFFINITY protocol and statistical analysis plan.

Final results from the first of two analyses of the custirsen Phase 3 AFFINITY trial are expected by the end of this year. The first of these two analyses will determine the ability of custirsen to extend survival in a subgroup of men who are at increased risk for poor outcomes. This group is comprised of men having two or more of five common clinical features, including poor performance status, elevated prostate-specific antigen (PSA), elevated lactate dehydrogenase (LDH), decreased hemoglobin, and the presence of liver metastasis. If the final analysis shows efficacy in this subgroup, OncoGenex would proceed with discussions with the FDA and a new drug application filing.

At the same time as the final analysis for the subgroup, interim analyses for both futility and efficacy is scheduled to occur in the intent to treat, or entire patient population, of the AFFINITY trial. If this interim analysis shows early efficacy, OncoGenex would proceed with an NDA filing for the entire trial population. If the early efficacy interim analysis does not show a highly significant difference, the study will continue as planned with final results are expected in the second half of 2016.
Apatorsen – Phase 2 Bladder, Lung Cancer Trials

On September 27, 2015, the company announced additional analyses from the Borealis-1 trial for its other lead product candidate, apatorsen. The results confirmed that patients with advanced bladder cancer at increased risk for poor outcomes had increased baseline levels of both circulating tumor cells (CTC) and serum heat shock protein 27 (Hsp27). The study showed that baseline Hsp27 and CTC levels were additional risk factors for survival outcomes. These results were presented at ECC 2015 and have been accepted for oral presentation at the upcoming 7th European Multidisciplinary Meeting on Urological Cancers (EMUC 2015).

On September 30, 2015, the company announced that Borealis-2, an investigator-sponsored, randomized Phase 2 trial, met its target enrollment of 200 patients. The trial is designed to evaluate apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. Borealis-2 is sponsored by Hoosier Cancer Research Network and being conducted at 27 sites across the United States. Results are expected in 2016.

Primary progression-free survival (PFS) results from the Spruce trial are expected in the first quarter of 2016, with continued survival follow up expected later next year. The Spruce trial is an investigator-sponsored, randomized, placebo-controlled Phase 2 trial designed to determine if adding apatorsen to carboplatin and pemetrexed therapy can extend PFS outcome in patients with previously untreated advanced non-squamous NSCLC.

"This is a pivotal time in the company’s history with results expected by the end of this year from the first of two custirsen Phase 3 AFFINITY trial final analyses. We look forward to this important milestone," said Scott Cormack, President and CEO of OncoGenex. "We anticipate additional milestones throughout 2016 including final survival analysis of all patients from the AFFINITY study and possible ENSPIRIT lung cancer results, as well as several upcoming Phase 2 data readouts in our apatorsen program."

Financial Update and Results

As of September 30, 2015, our cash, cash equivalents and short-term investments increased to $65.9 million from $47.1 million as of December 31, 2014.
Based on our current expectations, we believe that our cash, cash equivalents, and short-term investments will be sufficient to fund our currently planned operations into the first quarter of 2017, which may include:
announcing AFFINITY trial results, including final results of the poor prognosis subpopulation by the end of 2015 and final analysis for the ITT population in the second half of 2016, depending on timing of the event-driven final analysis;
announcing ENSPIRIT trial results, which could be available in the second half of 2016;
announcing Spruce trial results for the primary PFS endpoint in the first quarter of 2016;
announcing Borealis-2 trial results in 2016;
completing enrollment in the Pacific trial; and,
continuing enrollment in the Spruce-2 trial, formerly referred to as the Cedar Trial
Revenue for the three months ended September 30, 2015 increased to $6.7 million from $4.8 million for the three months ended September 30, 2014. Revenue for the nine months ended September 30, 2015 decreased to $12.1 million from $21.5 million for the nine months ended September 30, 2014.
Total operating expenses for the three and nine months ended September 30, 2015 were $11.4 million and $27.4 million, respectively, compared to $12.0 million and $44.3 million for the three and nine months ended September 30, 2014, respectively.
Net loss for the three and nine months ended September 30, 2015 was $4.6 million, or $0.16 per diluted common share, and $15.1 million, or $0.60 per diluted common share, respectively, compared with $4.9 million, or $0.23 per diluted common share, and $20.6 million, or $1.21 per diluted common share for the three and nine months ended September 30, 2014, respectively.
As of November 12, 2015, OncoGenex had 29,804,273 shares outstanding.