On November 10, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the third quarter of 2016 and provided an update on its research and development activities (Press release, ImmunoCellular Therapeutics, NOV 10, 2016, View Source [SID1234516541]).

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Andrew Gengos, ImmunoCellular’s Chief Executive Officer, commented: "During the third quarter and year to date, we continued to implement our ICT-107 registration trial in patients with newly diagnosed glioblastoma, and conduct our phase 1 trial of ICT-121 in patients with recurrent glioblastoma. Today, in our ICT-107 phase 3 trial, about 225 patients have been screened, 11 have been randomized, and clinical site activation is continuing, with a total of 66 sites activated to date. We have determined that the number of patients who complete screening and then proceed to randomization, post-chemoradiation, is lower than expected, and thus the rate of randomization is slower than we would like. To address this challenge, we are implementing a protocol amendment for the ICT-107 trial that will modify some elements of how patients qualify for the trial, which is designed to accelerate the pace and efficiency of randomization. We also anticipate increasing the target number of randomized patients, which would extend the timeline to trial completion. We are continuing to screen and randomize patients, and anticipate completing the amendment process in the first quarter of 2017."

Continued Mr. Gengos: "The phase 1 open-label trial of ICT-121 being conducted at six sites in the U.S. completed enrollment of 20 patients in the third quarter. The preliminary results thus far are encouraging, showing a current median survival of 13.8 months as of October 31st, seven patients who are alive beyond 18 months, and four patients who are alive at the two-year mark. We are continuing to monitor outcomes, with the goal of having preliminary data by mid-2017, potentially in time for the ASCO (Free ASCO Whitepaper) 2017 meeting. We are grateful for the continued support of the medical and scientific cancer community for our clinical programs, and the confidence placed in our company by our collaborators."

Achievements, Upcoming Goals and Milestones:

ICT-107:
Continue to bring U.S., Canadian and European clinical sites online. A total of 75 site initiation visits have been completed, and 66 sites have been activated to date.
A protocol amendment is underway, which will modify some elements of how patients qualify for the trial, raise the target number of randomized patients from 414 to at least 500 and result in a potential 12 to 18 month extension to complete the trial. We now anticipate randomization of all patients to be completed by the first half of 2019, and an additional 2-3 years from then to achieve the number of required events.
Plan to conduct a futility interim analysis at 30% of events, or at about the time of full randomization, and an efficacy interim analysis at 67% of events, about six months later.
Present updated immune monitoring data from the ICT-107 phase 2 trial and updated long-term survival data from the phase 1 trial at the 2016 Society for NeuroOncology annual scientific meeting, being held in Scottsdale, AZ in two oral presentations.
Friday, November 18, 4:35 pm MT, Adult Clinical Trials – Immunological (ATIM-19) "Categorizing immune responders with fusion metrics and simulation for association to survival and progression-free survival with immune response in HLA-A2+ patients with GBM from a phase 2 trial of dendritic cell (DC) immunotherapy (ICT-107)," presented by Steven J. Swanson, PhD, ImmunoCellular Therapeutics, Ltd, Calabasas, CA.
Friday, November 18, 4:40 pm, MT, Adult Clinical Trials – Immunological (ATIM-25): "Ten-year follow up with long term remission in patients with newly diagnosed glioblastoma (GBM) treated with ICT-107 vaccine (phase 1)," presented by Surasak Phuphanich, MD, Neuro-Oncology Program, Department of Neurosurgery & Neurology, Cedars-Sinai Medical Center, Los Angeles, CA
ICT-121:
Continuing to monitor patients, with data expected around mid-2017.
Research:
Anticipate having one or more T cell receptors identified for a Stem-to-T-cell clinical candidate or candidates by year-end 2016.
Initial attempt to package a T cell receptor DNA sequence in the lentivirus/gene therapy construct by year-end 2016.
Continued progress in collaboration with University of Maryland on projects that have application to existing dendritic cell immunotherapy and Stem-to-T-cell technology platforms.
Third Quarter 2016 Financial Results

For the quarter ended September 30, 2016, ImmunoCellular incurred a net loss of $4.8 million, or $0.04 per basic and diluted share, compared to a net loss of $3.4 million, or $0.04 per basic and diluted share, for the quarter ended September 30, 2015.

During the third quarter 2016, ImmunoCellular incurred $4.6 million of research and development expenses compared to $2.7 million in the prior year quarter, while general and administrative expenses decreased to $908,000 compared to $1.1 million in the prior year. The $1.9 million increase in research and development expenses primarily reflects the additional expenses associated with the phase 3 trial of ICT-107. The decrease in general and administrative expenses reflects lower professional fees in the current quarter.

The loss for the current quarter was partially offset by a $1.1 million credit to other income to reflect a reduction in the valuation of the Company’s warrant derivative liabilities. In the same quarter of the prior year, the Company recorded a corresponding credit of $339,000.

For the nine months ended September 30, 2016, ImmunoCellular incurred a net loss of $15.8 million, or $0.15 per basic and diluted share, compared to a net loss of $8.0 million, or $0.09 per basic and diluted share. During the nine months ended September 30, 2016, ImmunoCellular incurred $13.7 million in research and development expenses compared to $7.0 million in the prior year.

ImmunoCellular also reported that cash used in operations during the nine months ended September 30, 2016 was $16.1 million compared to $13.2 million in the prior year. The increase primarily reflects the additional research and development expenditures in the current year. As of September 30, 2016, ImmunoCellular had $15.3 million in cash.

In August 2016, the Company entered into an underwriting agreement with Maxim Group LLC, pursuant to which the Company received net proceeds of approximately $6.6 million (after deducting the underwriting discount and offering expenses) from the initial sale of 34.6 million shares of the Company’s common stock, base warrants to purchase 35,250,000 shares of common stock at an exercise price of $0.1921 per share, and pre-funded warrants to purchase 12,450,000 shares of common stock at an exercise price of $0.01 per share. The underwriters partially exercised their option to purchase additional shares and base warrants and purchased an additional 1,500,000 million shares of the Company’s common stock at a price of $0.15 per share and base warrants to purchase 4,478,625 shares. The pre-funded warrants were substantially paid for at the time of the offering and have an exercise price of $0.01 per share. As of September 30, 2016, the Company had 137,795,802 shares of common stock issued and outstanding.

Additionally, the terms of the California Institute of Regenerative Medicine (CIRM) award were modified such that ImmunoCellular received an additional $1.5 million in August 2016 as part of the initial award received from CIRM. The total amount of the award and other award conditions remain unchanged.

On November 10, 2016 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first nine months of 2016 (Press release, Evotec, NOV 10, 2016, View Source [SID1234516586]).

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FINANCIAL PERFORMANCE – PROFITABLE AND STRONG GROWTH

– Strong revenue growth in both operating segments:

EVT Execute revenues up 36% to EUR 126.6 m;
EVT Innovate revenues up 26% to EUR 17.9 m
– Consolidated Group revenues up 37% to EUR 120.6 m (9M 2015: EUR 88.2 m); base revenues up 30% to EUR 105.0 m

– Adjusted Group EBITDA increased to EUR 30.6 m (9M 2015: EUR 3.4 m)

– R&D expenses of EUR 12.8 m

– Strong liquidity position of EUR 120.0 m despite loan repayments

EVT EXECUTE – STRONG OPERATIONAL PERFORMANCE

– Significant milestone achievements in Bayer, Boehringer Ingelheim and Padlock collaborations

– Phase I clinical start for the treatment of endometriosis with Bayer

– Extensions of ongoing collaboration, e.g. with Genentech and Janssen Pharmaceutica NV

– New long-term strategic drug discovery alliances, e.g. with C4X Discovery, Antibiotic Research UK, UCB

– New compound management partnerships, e.g. with Pierre Fabre and UCB

– New licences enhancing existing drug discovery platform, e.g. with CRISPR/Cas9 and Trianni

– Proposed acquisition of ADME-Tox and DMPK specialist company Cyprotex PLC (after period-end)

EVT INNOVATE – NEW PATHS OF ACCELERATING FIRST-IN-CLASS DRUG DISCOVERY

– New multi-target alliance with Bayer in kidney diseases

– First research collaboration under French Academic Bridge with Inserm in oncology

– Acceleration of TargetNASH programme with Ellersbrook GmbH & Co. KG

– Innovation partnership with ex scientia to develop bispecific small molecule immuno-oncology therapeutics

– Formation of spin-off company Topas Therapeutics GmbH in the field of nanoparticle-based therapeutics to treat immunological disorders

– Participation in Series A funding of Carrick Therapeutics

– Establishing of EVT BRIDGE LAB282 partnership with Oxford University, OSI and OUI (after period-end)

ALL ELEMENTS OF GUIDANCE CONFIRMED – PROFITABILITY GUIDANCE RAISED IN JULY 2016

– Adjusted Group EBITDA (before changes in contingent consideration) expected to more than double compared to 2015

– All other elements of financial guidance as of 22 March 2016 and positive outlook confirmed

– Strong initial outlook for 2017

1. FINANCIAL PERFORMANCE

PROFITABLE AND STRONG GROWTH

Evotec’s Group revenues for the first nine months of 2016 grew to EUR 120.6 m, an increase of 37% compared to the same period of the previous year (9M 2015: EUR 88.2 m). This increase is due to growth in the core EVT Execute business, a full nine month contribution of the Sanofi collaboration as well as significant milestone payments. Excluding milestones, upfronts and licences, Evotec’s base revenues for the first nine months of 2016 were EUR 105.0 m and increased by 30% over the same period of the previous year (9M 2015: EUR 80.7 m). The gross margin in the first nine months of 2016 was strong at 38.5% and improved over the first nine months of 2015 (9M 2015: 27.2%). The margin increase over 2015 is attributable to the same drivers as the trend in revenue growth as well as capacity utilisation and favourable foreign exchange rate effects.

R&D expenses for the first nine months of 2016 decreased by 5% to EUR 12.8 m (9M 2015: EUR 13.5 m) due to successful partnering of EVT Innovate projects in 2015. Total SG&A expenses for the first nine months of 2016 decreased by 7% to EUR 17.8 m (9M 2015: EUR 19.0 m). SG&A expenses in 2015 included one-time M&A and related costs. Adjusted Group EBITDA in the first nine months of 2016 increased significantly to EUR 30.6 m (9M 2015: EUR 3.4 m). Evotec’s operating result for the first nine months of 2016 amounted to EUR 20.4 m (9M 2015: EUR 12.3 m).

Liquidity, which includes cash and cash equivalents (EUR 62.4 m) and investments (EUR 57.6 m) amounted to EUR 120.0 m at the end of September 2016 (31 December 2015: EUR 133.9 m). In Q2 2016, Evotec initiated the repayment of loans, which was continued in Q3 2016.

Revenues from the EVT Execute segment amounted to EUR 126.6 m in the first nine months of 2016, an increase of 36% compared to the prior-year period (9M 2015: EUR 93.4 m). Included in this amount are EUR 23.9 m of intersegment revenues (9M 2015: EUR 19.5 m). The EVT Innovate segment generated revenues in the amount of EUR 17.9 m consisting entirely of third-party revenues (9M 2015: EUR 14.3 m). The increase in revenues resulted from EVT Innovate projects which were partnered in 2015. Gross margin for EVT Execute amounted to 32.9% while EVT Innovate generated a gross margin of 45.6%. R&D expenses for the EVT Innovate segment at EUR 16.3 m in the first nine months of 2016 remained largely unchanged (9M 2015: EUR 16.6 m). Due to growth in the base business, milestone achievements and three full quarters of the Sanofi contribution, the adjusted EBITDA of the EVT Execute segment amounted to EUR 41.3 m in the first nine months of 2016 and increased significantly compared to EUR 16.1 m in the prior-year period. The EVT Innovate segment reported an improved adjusted EBITDA of EUR (10.7) m (9M 2015: EUR (12.7) m).

2. EVT EXECUTE & EVT INNOVATE

EVT EXECUTE – STRONG OPERATIONAL PERFORMANCE

During the first nine months of 2016, EVT Execute demonstrated a strong operational performance, shown also by important milestones achievements in its collaborations with Bayer, Boehringer Ingelheim and Padlock. Furthermore, Evotec was able to announce the progression of a first programme from its strategic alliance with Bayer in the field of endometriosis into Phase I clinical development. In addition, the compound management business is gaining momentum, underlined by new alliances with UCB and Pierre Fabre. Various collaborations were extended in the first nine months of 2016, such as the drug discovery alliances with Genentech and Janssen Pharmaceutica NV. Additionally, Evotec was able to enter new drug discovery alliances with C4X Discovery, UCB and Antibiotic Research UK, the latter underlining the recent trend of an increasing number of non-governmental organisations and foundations accessing Evotec’s drug discovery platforms.

Consistent with the Company’s strategy to offer its clients the most advanced technological platforms, Evotec continued to expand its drug discovery platforms, e.g. with a non-exclusive licence to the leading technology on the market for gene editing (CRISPR-Cas9 licence) and Trianni’s next-generation transgenic technology. Along these lines, Evotec announced the proposed acquisition of Cyprotex PLC after period-end, which would add world-leading high-quality ADME-Tox services and strengthen Evotec’s leadership in drug discovery. This proposed acquisition, which has been unanimously recommended by the board of Cyprotex, is expected to close before year-end 2016.

EVT INNOVATE – NEW PATHS OF ACCELERATING FIRST-IN-CLASS DRUG DISCOVERY

The EVT Innovate portfolio continued to make very good scientific and commercial progress in the third quarter of 2016, resulting in a very strong performance of the segment. EVT Innovate again demonstrated its ability to partner promising early-stage scientific approaches with Pharma companies with the start of a five-year, multi-target alliance with Bayer in the field of kidney diseases based on assets from its CureNephron portfolio. Furthermore, the Company entered into its first research collaboration under its French Academic Bridge with Inserm in the field of oncology. In addition, EVT Innovate is accelerating its TargetNASH programme together with Ellersbrook GmbH & Co. KG, with both partners committed to investing up to EUR 5 m over an initial three-year period. An innovation partnership with ex scientia (UK) to develop bispecific small molecule immuno-oncology therapeutics was formed.

In March 2016, Evotec announced the formation of a spin-off company called Topas Therapeutics GmbH, focused in the field of nanoparticle-based therapeutics to treat autoimmune diseases. The establishment of Topas is the first example of the acceleration of Evotec’s business model to take advantage of carving out or investing in promising programmes with additional upside potential. In addition, Evotec announced an investment of up to $ 6 m towards Carrick Therapeutics’ latest $ 95 m funding round, thereby deepening its already existing relationship with Carrick.

EVT Innovate is also pursuing new approaches in scouting new innovations and accelerating them along the drug discovery value chain. After period-end, Evotec announced a highly innovative strategic partnership called "LAB282" with the University of Oxford, Oxford University Innovation Ltd and Oxford Sciences Innovation aimed at accelerating the translation of basic biomedical research from Oxford into new clinical therapeutics. These efforts, referred to as "EVT BRIDGE", are focused on highly capital efficient translation of academic science into potentially transformative pharmaceutical projects.

3. ALL ELEMENTS OF GUIDANCE CONFIRMED

PROFITABILITY GUIDANCE RAISED IN JULY 2016

Evotec’s financial guidance was last updated in July 2016 due to an increased margin contribution and a positive outlook for the remainder of the year.

Guidance July 2016 Original Guidance 2016 Actual 2015

Group revenues1)

More than 15% growth

More than 15% growth
EUR 115.4 m
Adjusted Group EBITDA2)
More than double Positive and significantly improved compared to prior year EUR 8.7 m
R&D expenses Approx. EUR 20 m Approx. EUR 20 m EUR 18.3 m

Liquidity3)
Similar level compared
to 2015

Similar level compared to 2015 EUR 134.5 m
Capex investments Up to EUR 10 m Up to EUR 10 m EUR 11.2 m
1) Excluding milestones, upfronts and licences
2) Before contingent considerations, income from bargain purchase and excluding impairments on goodwill, other intangible and tangible assets as well as the total non-operating result
3) Excluding any potential cash outflow for M&A or similar transactions

On November 10, 2016 RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage company developing innovative therapeutics that address significant unmet medical needs, reported its financial results for the third quarter ended September 30, 2016, and provided a business update (Filing, 8-K, RXi Pharmaceuticals, NOV 10, 2016, View Source [SID1234516723]).

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"In the third quarter of 2016, RXi has once again been able to keep its cash burn in line with our projections, while continuing the clinical development programs as planned," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He further added, "In recent weeks we announced an exclusive option to acquire MirImmune, Inc., a small biotech company that uses our proprietary RNAi technology in the field of cell therapy and immune-oncology. We are excited that this potential acquisition would allow RXi to embark on a significant path forward in the development of novel cancer therapeutics. In the past years our Company has shown, through its own clinical programs and external collaborations, that its uniquely structured RNAi compounds are effective in various animal and tissue culture models, as well as in the treatment of hypertrophic scarring, a human clinical model for fibrosis.

While we continue to work toward an acquisition of MirImmune, we expect to provide updates on most of our clinical and consumer health programs before the end of 2016, as well as an outlook on projects, timelines and milestones for the combined company in the first quarter of 2017. We continue to focus on building value for our shareholders by creating novel therapeutics, for a better life for patients."

The Company will host a conference call today at 4:30 p.m. EDT to discuss financial results and provide an update on the Company. The webcast link will be available under the "Investors – Event Calendar" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States and Canada: +1 (888) 674-0219. International participants may access the event by dialing: +1 (862) 225-5367. An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.

Select Third Quarter 2016 Financial Highlights
Cash Position
At September 30, 2016, the Company had cash, cash equivalents and short-term investments of approximately $4.4 million, compared with $10.6 million at December 31, 2015.
Research and Development Expenses
Research and development expenses for the quarter ended September 30, 2016 were $1.5 million, compared with $1.7 million for the quarter ended September 30, 2015. Research and development expenses decreased from the prior year’s quarter primarily due to manufacturing expenses for the RXI-109 drug product completed in the second half of 2015, offset by increases in manufacturing and clinical trial-related costs for Samcyprone. Research and development expenses further decreased due to a reduction in stock-based compensation expense related to the full vesting of stock options granted in 2012.

General and Administrative Expenses
General and administrative expenses for the quarter ended September 30, 2016 were $0.7 million as compared with $0.8 million for the quarter ended September 30, 2015. The decrease in general and administrative expenses was primarily due to a decrease in stock-based compensation expense related to the full vesting of stock options granted in 2012, offset by an increase in expenses related to the use of outside professional services due to the Company’s increased business development activities in line with its key corporate initiatives.

Net Loss
Net loss for the quarter ended September 30, 2016 was $2.2 million, compared with $2.5 million for the quarter ended September 30, 2015. Net loss decreased from the prior year’s quarter primarily due to the change in research and development expenses, as discussed above.
Select Business and Corporate Highlights
RXi has developed a robust self-delivering RNAi (sd-rxRNA) therapeutic platform where drug-like and delivery properties are built directly into the compound itself. There is no need for delivery vehicles for local applications and our self-delivering platform has been shown to be compatible with various systemic systems. Due to the fact these compounds can be designed to selectively block the expression of any target in the genome, our technology is applicable to a broad spectrum of therapeutic areas.
In March 2015, MirImmune, Inc., a privately-held company focused on the development of next generation immunotherapies for the treatment of cancer, entered into an exclusive license agreement for use of RXi’s sd-rxRNA technology in developing innovative cell-based cancer immunotherapies. Since that time, MirImmune’s progress in cell therapy using RXi’s technology has formed a strong foundation for therapeutic development in the immuno-oncology space.
Last month, RXi entered into an exclusive option to acquire MirImmune, Inc., in consideration for a number of shares equal to 19.99% of the then outstanding shares of common stock of RXi, plus additional potential consideration contingent on MirImmune reaching certain milestones.
Upon RXi’s exercise of its option to acquire MirImmune, the acquisition would not only allow the Company to create value for our shareholders, it more importantly sets the stage for what could potentially be a transformational change in the way we treat patients with various malignancies.
The Company’s goal, through internal research and external partnerships, is to develop more tolerable treatments resulting in better quality of life and extended survival for patients. This approach is a key first step into the field of cell-based therapies, where sd-rxRNA has numerous advantages over other RNAi technologies.

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.