NantKwest has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, NantKwest, NOV 10, 2016, View Source [SID1234516557]).

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On November 10, 2016 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported its third quarter 2016 financial results (Press release, OncoGenex Pharmaceuticals, NOV 10, 2016, View Source [SID1234516669]).

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Recent Events

In November 2016, the company announced positive survival results from the final analysis of the Phase 2 Borealis-2 trial of apatorsen in combination with docetaxel treatment that enrolled 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy. The company does not currently intend to fund further development of apatorsen in bladder cancer without a collaboration partner.
Also in November 2016, OncoGenex discontinued the development of its custirsen program after the AFFINITY and ENSPIRIT Phase 3 clinical trials failed to meet their primary endpoints.
Financial Results
As of September 30, 2016, the company’s cash, cash equivalents, and short-term investments were $32.5 million compared with $55.2 million as of December 31, 2015. Based on current expectations, OncoGenex believes that its cash, cash equivalents, and short-term investments will be sufficient to fund its currently planned operations for at least the next 12 months.

Revenue for the three and nine months ended September 30, 2016 decreased to zero and $5.1 million, respectively, from $6.7 million and $12.1 million for the three and nine months ended September 30, 2015, respectively. The advanced reimbursement payment made by Teva, as part of the Termination Agreement, was deferred and recognized as collaboration revenue on a dollar for dollar basis as costs were incurred as part of the continuing research and development activities related to custirsen. The decrease in collaboration revenue in 2016 as compared to 2015 was due to the full recognition of the remaining amounts of deferred revenue in 2016.

Total operating expenses for the three and nine months ended September 30, 2016 were $4.4 million and $20.2 million, respectively, compared to $11.4 million and $27.4 million for the three and nine months ended September 30, 2015, respectively.

Net loss for the three and nine months ended September 30, 2016 was $3.7 million and $14.3 million, respectively, compared to $4.6 million and $15.1 million for the three and nine months ended September 30, 2015, respectively.

As of November 10, 2016 OncoGenex had 30,020,294 shares outstanding.

OncoGenex is continuing work with MTS Health Partners in the exploration of strategic alternatives as announced in mid-August.

On November 10, 2016 IntelGenx Technologies Corp. (TSX-V: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") reported its third quarter 2016 financial results for the three-month and nine-month periods ended September 30, 2016 (Filing, Q3, IntelGenx, 2016, NOV 10, 2016, View Source [SID1234516563]). All amounts are in U.S. Dollars unless otherwise stated. The Company will host a conference call today at 4:30 p.m. EST to provide a corporate update.

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2016 Third Quarter Financial Highlights:

• Revenue was $1.8 million, compared to $2.4 million over the same period last year
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Net comprehensive income was $62 thousand, compared to net comprehensive income of $1.2 million over the same period last year

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Adjusted EBITDA was $311 thousand, compared to adjusted EBITDA of $1.4 million over the same period last year

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Cash and short-term investments totaled $5.7 million as at September 30, 2016 compared to the balance of $2.9 million as at December 31, 2015

Recent Highlights:

• Signed commercialization term sheet for RizaportTM with Pharmatronic for Korea
•
Announced the successful completion of a phase 1 clinical study of Montelukast that demonstrated a significantly improved pharmacokinetic profile – bioavailability increased by 52% against the reference product. Montelukast is approved for the treatment of asthma and has shown promising results in the treatment of degenerative diseases of the brain, such as mild cognitive impairment and Alzheimer’s disease, the most prominent form of dementia

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Signed a development and commercialization agreement with Chemo Group for three generic products

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Monetized its royalty on future sales of Forfivo XL to SWK Holdings Corporation for $6 million (CAD$8 million) – the largest influx of capital in the history of the company

"We are most pleased by our progress in executing our business plan and transforming IntelGenx into a global leader in pharmaceutical oral films," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "The completion of the definitive agreement with Chemo Group is a significant achievement for the Company. This important strategic partnership offers IntelGenx an opportunity to expand its global reach with its innovative product pipeline. The excellent results from our recently completed phase 1 study with Montelukast demonstrating a significantly increased bioavailability of the drug further confirms that this important drug repurposing opportunity has the potential to significantly accelerate IntelGenx’ long-term growth."

Financial Results:
Total revenues for the three-month period ended September 30, 2016 amounted to $1.8 million, representing a decrease of $564 thousand or 24% compared to $2.4 million for the three-month period ended September 30, 2015. The decrease for the three-month period ended September 30, 2016 compared to the last year’s corresponding period is mainly attributable to a decrease in royalties of $248 thousand as well as a decrease in milestone revenues of $1.7 million and a decrease in deferred license revenues of $409 thousand, offset by an increase in upfront and deferred revenue on monetization of $1.8 million. Going forward, the royalty revenue should diminish due to the Company’s strategic decision to monetize the royalty on future sales of Forfivo XL.

Operating costs and expenses were $1.7 million for the three-month period ended September 30, 2016 compared to $1 million for the corresponding period of 2015. The increase for the three-month period ended September 30, 2016 is mainly attributable to an increase in Research and Development expenses of $114 thousand and Selling, General and Administrative of $519 thousand. The increase in expenses relates to the investment into additional hiring’s to strengthen IntelGenx’s team as it executes its strategic plan to establish its state-of-the-art manufacturing facility.

For the third quarter of 2016, the Company generated operating income of $88 thousand compared to operating income of $1.4 million for the comparable period of 2015.

Net comprehensive income was $62 thousand or $0.00 on a basic and diluted per share basis for the third quarter of 2016 compared to net comprehensive income of $1.2 million or $0.02 on a basic and diluted per share basis for the comparable period of 2015.

"We are pleased that the company is well funded to advance our current innovative pipeline forward," said Andre Godin, Executive Vice-President and CFO of IntelGenx. "The Company is working hard to bring further visibility to the marketplace in building a stronger presence in the capital markets."

Cash and short-term investments as at September 30, 2016 was $5.7 million, representing an increase of $2.8 million compared with the balance of $2.9 million as at December 31, 2015. The increase in cash relates to the monetization of its royalty on future sales of Forfivo XL to SWK Holdings Corporation for $6 million (CAD$8 million).

On November 10, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported its financial results and provided a general business update for the third quarter and nine months ended September 30, 2016 (Press release, Heat Biologics, NOV 10, 2016, View Source [SID1234516526]).

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"We look forward to reporting top-line data in both our bladder and lung cancer trials within the next few weeks," commented Jeff Wolf, Heat’s Founder and CEO. "Our results come on the heels of encouraging interim study findings from our Phase 1b trial evaluating HS-110 in combination with the Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, nivolumab. Our data in lung cancer suggest HS-110 may improve response rates for patients with ‘cold tumors’ who typically have lower response rates to checkpoint inhibitor monotherapy. We are also encouraged by our early data in bladder cancer that suggest we are activating a robust antigen-specific immune response.

"Moreover, we are pleased to announce the expansion of our gp96 platform into the infectious disease arena. We recently formed a new subsidiary, Zolovax, which will focus exclusively on developing gp96-based vaccines for Zika and other infectious diseases, such as HIV, West Nile, dengue and yellow fever. Preclinical studies suggest that our gp96 platform may have a role as a broad-based infectious disease vaccine. Importantly, in the case of Zika, the robust mucosal immune response generated by gp96 in ongoing oncology studies may suggest that a gp96 vaccine could also stimulate a Zika-specific immune response in the placenta, thus protecting the fetus from virus transmission.

"During the third quarter, we strengthened our balance sheet and benefitted from the exercise of warrants and substantial pay down of our existing debt. I am pleased to report we ended the quarter with approximately $8.5 million of cash on hand. This year through November 10, 2016, we have generated over $3.1 million in cash from the exercise of our March 23, 2016 warrants. Meanwhile, we continue to carefully manage our expenses as we await important top-line data this quarter."

Recent Developments & Third Quarter 2016 Corporate Highlights

In late October, Heat announced that it entered into an agreement with the University of Miami for the license and development of a portfolio of patents leveraging its gp96 platform to target the Zika virus and other infectious diseases including HIV, West Nile, dengue and yellow fever.
In October, Heat announced that it has advanced its biomarker discovery collaboration with Adaptive Biotechnologies. Adaptive will use its patented immune profiling assay, immunoSEQ, to enable an in-depth characterization of the immune response to Heat’s ImPACT and ComPACT-based immunotherapies, including HS-410, Heat’s Phase 2 product candidate for non-muscle invasive bladder cancer.
In September, Heat announced that it had resumed enrollment in its Phase 1b trial evaluating HS-110 in combination with nivolumab (Opdivo), a Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, for the treatment of non-small cell lung cancer (NSCLC). The decision to resume trial enrollment was based on the encouraging data reported in June, including two clinical responses in "cold tumor" patients. There are currently 15 patients enrolled and the Company expects to report topline 6-month data on the first eight of these patients before year end.
In July, Heat announced that preclinical findings from its ComPACT platform technology were published online in the journal "Cancer Immunology Research." Heat demonstrated that its ComPACT technology secreting the co-stimulator OX40L enhanced tumor rejection in two cancer tumor types compared to OX40 agonist antibody treatment. Heat also reported that ComPACT-enhanced antigen-specific T cell infiltration into tumors improved memory T cell responses and demonstrated greater specificity than OX40 agonist antibody treatments.
Third Quarter 2016 Financial Highlights

Research and development (R&D) expenses decreased to approximately $0.6 million in the third quarter of 2016 compared to approximately $0.7 million in the third quarter of 2015, a decrease of approximately $0.1 million. The decrease is primarily attributable to reductions in consultant fees and a decrease in compensation costs attributable to deferral of salary as part of our cost-savings plan.
Clinical and regulatory expenses decreased to approximately $1.1 million in the third quarter of 2016 compared to approximately $3.7 million in the third quarter of 2015, a decrease of approximately $2.6 million. The decrease is primarily attributable to reductions in clinical trial execution costs.
General and administrative (G&A) expenses decreased to approximately $0.8 million in the third quarter of 2016 compared to approximately $0.9 million in the third quarter of 2015, a decrease of $0.1 million. The decrease is attributable to a reduction in compensation costs and work force reductions as part of the cost-savings plan.
Net loss for the third quarter of 2016 was $1.7 million compared to a net loss of $5.4 million for the third quarter of 2015.
Nine Months Ended September 30, 2016 Financial Highlights

R&D expenses decreased to approximately $1.5 million for the nine months ended September 30, 2016 compared to approximately $1.8 million for the nine months ended September 30, 2015, a decrease of approximately $0.3 million. The decrease is attributable to reductions in patent, license and other professional fees, as well as a decrease in consultant expense and a decrease in compensation costs attributable to deferral in salary as part of our cost-savings initiatives.
Clinical and regulatory expenses decreased to approximately $5.6 million for the nine months ended September 30, 2016 compared to approximately $9.2 million for the nine months ended September 30, 2015, a decrease of approximately $3.6 million. The decrease is primarily attributable to reductions in clinical trial execution expenses.
G&A expenses decreased to approximately $2.9 million for the nine months ended September 30, 2016 compared to approximately $3.1 million for the nine months ended September 30, 2015, a decrease of approximately $0.2 million. The decrease is primarily attributable to a decrease in compensation costs attributable to deferral of salary and work force reductions as part of our cost-savings plan.
Net loss for the nine months ended September 30, 2016 was $9.4 million compared to a net loss of $14.4 million for the nine months ended September 30, 2015.
Cash and cash equivalents totaled approximately $8.5 million at September 30, 2016 compared to cash, cash equivalents and short-term investments which totaled approximately $11.6 million at December 31, 2015.

On November 10, 2016 ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with cancer, reported its financial and operational results for the third quarter of 2016 (Press release, ProNAi Therapeutics, NOV 10, 2016, View Source [SID1234516692]).

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"Over the past few months we’ve successfully re-established ProNAi as a clinical stage oncology company advancing promising drug candidates that target the DNA Damage Response (DDR) network. This is a particularly compelling target space in oncology, highlighted by growing enthusiasm for the PARP inhibitors, which also inhibit a component of the DDR network," said Dr. Nick Glover, President and CEO of ProNAi Therapeutics. "Our candidates seek to leverage the DDR network beyond PARP with ‘next generation’ DDR therapeutics targeting Chk1 and Cdc7, and we plan to conduct broad clinical development programs for these assets supported by robust research with the goal of efficiently determining their potential utility for the treatment of a variety of oncology indications."

During the quarter, ProNAi reported it had licensed the exclusive worldwide rights to PNT737, a highly selective, orally available, small molecule inhibitor of Checkpoint kinase 1 (Chk1). PNT737 is being investigated in two Phase 1 clinical trials being conducted at the Royal Marsden NHS Foundation Trust and other centers in the United Kingdom. ProNAi anticipates expanding on the current clinical program underway for PNT737, including into the United States, with the expectation of filing an Investigational New Drug application in the second half of 2017.

To support broader studies in well-defined patient populations, ProNAi plans to conduct research designed to explore markers of sensitivity to PNT737 that may facilitate patient selection and to identify additional therapeutic combination opportunities. A possible development path for PNT737 is the treatment of tumors carrying mutations in genes known to contribute to DNA damage and genomic instability – a key hallmark of cancer. The significant and persistent DNA damage caused by these mutations, coupled with Chk1 inhibition, may result in death of the cancer cells, a synergistic effect referred to as ‘synthetic lethality’. Similarly, excessive DNA damage can be induced with other DDR targeting agents such as PARP inhibitors, as well as certain chemotherapies or radiation, highlighting the potential for synergies between these modalities and Chk1 inhibition.

ProNAi is also advancing PNT141, a Cdc7 inhibitor that regulates DNA replication and the DDR network in a different, potentially complementary way to PNT737. Inhibiting both Chk1 and Cdc7 simultaneously may be advantageous and presents the potential for novel combination strategies for PNT737 and PNT141.

Third Quarter 2016 Financial Results (all amounts reported in U.S. currency)
Research and development expenses increased to $12.3 million for the three months ended September 30, 2016 from $8.3 million for the three months ended September 30, 2015. Research and development expenses increased to $28.1 million for the nine months ended September 30, 2016 from $18.3 million for the nine months ended September 30, 2015. These increases in 2016 were primarily due to a $7.0 million upfront fee due to CRT Pioneer Fund LP (CPF) for the exclusive license of PNT737, the recognition of a $2.0 million fee that will be due upon the successful transfer of two ongoing clinical trials in accordance with the license agreement and a $0.9 million upfront fee paid to Carna Biosciences, Inc. for the exclusive license of PNT141. The remaining increase was attributable to increased personnel-related costs and a non-recurring $2.4 million restructuring charge related to estimated close-out expenses for PNT2258. These were partially offset by a decrease in third-party manufacturing and clinical trial costs.

General and administrative expenses increased to $3.0 million for the three months ended September 30, 2016 from $2.7 million for the three months ended September 30, 2015. General and administrative expenses increased to $10.8 million for the nine months ended September 30, 2016 from $6.1 million for the nine months ended September 30, 2015. These increases in 2016 were primarily due to increased personnel-related costs and fees incurred in support of activities as a public company and corporate growth, costs pertaining to business development activities and a $0.4 million non-recurring restructuring charge.

Total operating expenses for the three months ended September 30, 2016 were $15.3 million compared to $11.0 million for the three months ended September 30, 2015. Total operating expenses for the nine months ended September 30, 2016 were $38.8 million compared to $24.4 million for the nine months ended September 30, 2015. Total operating expenses included non-cash stock based compensation of $1.3 million and $4.0 million for the three and nine months ended September 30, 2016 and of $1.3 and $1.9 for the three and nine months ended September 30, 2015, respectively.

For the three months ended September 30, 2016, ProNAi incurred a net loss of $15.2 million compared to a net loss of $18.5 million for the three months ended September 30, 2015. For the nine months ended September 30, 2016, ProNAi incurred a net loss of $38.6 million compared to a net loss of $41.8 million for the nine months ended September 30, 2015. During the three and nine months ended September 30, 2015, net loss included a non-cash charge related to the change in fair value of preferred stock warrants of $7.5 million and $17.4 million.

At September 30, 2016, ProNAi had $122.7 million in cash and cash equivalents compared to $150.2 million in cash and cash equivalents at December 31, 2015. Subsequent to the end of the quarter, ProNAi paid the $7.0 million upfront fee due to CPF for the exclusive license of PNT737.

At September 30, 2016, there were 30,350,560 shares of common stock issued and outstanding and stock options to purchase 6,629,163 shares of common stock issued and outstanding.