On August 22, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the second quarter of 2016 (Filing, Q2, ImmunoCellular Therapeutics, 2016, AUG 22, 2016, View Source [SID:1234514672]).

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Andrew Gengos, ImmunoCellular Chief Executive Officer, commented: "We are pleased with the progress we made in the first half of this year, and believe that 2016 will be a year of accomplishment for our company. The first patient in the ICT-107 phase 3 trial was treated in June – a major achievement for our company. Today, more than 140 patients have been screened and clinical site activation is accelerating. We currently have activated 60 clinical sites in the US, two in Canada, and one in the UK, with more expected to come in the third quarter. With ICT-107, ImmunoCellular is one of a small number of companies in the cancer immunotherapy arena that we believe to be in the final stage of clinical development. In light of these achievements, our confidence remains high for the value and quality of our phase 3 program, and the therapeutic and commercial potential of ICT-107. The phase 1 open-label trial of ICT-121 in patients with recurrent glioblastoma has completed enrollment, reaching the target of 20 patients. The trial is being conducted at six sites in the US and preliminary results are expected in about 9 months. We are grateful for the continued support of the medical and scientific cancer community, and the confidence placed in our company by our collaborators."
Upcoming Goals and Milestones:

• ICT-107:

• Continue to bring US, Canadian and European clinical sites online, with the goal of having all sites in all 10 countries activated by the end of 2016.

• Anticipate randomization of all patients by the end of 2017, and an additional 2-3 years from then to achieve the at least 274 required events.

• Plan to conduct a futility interim analysis at 30% of events, or at about the 2-year mark, and an efficacy interim analysis at 67% of events, or at about the 2 1⁄2 -year mark.

• 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 Society for NeuroOncology annual scientific meeting in November 2016 in two oral presentations.
• ICT-121:

• Continuing to monitor patients, with data expected in about 9 months.

• 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.
Second Quarter 2016 Financial Results
For the quarter ended June 30, 2016, ImmunoCellular incurred a net loss of $5.3 million, or $0.06 per basic and diluted share, compared to a net loss of $3.2 million, or $0.03 per basic and diluted share, for the quarter ended June 30, 2015.
During the second quarter 2016, ImmunoCellular incurred $4.4 million of research and development expenses compared to $2.3 million in the prior year quarter while general and administrative expenses remained relatively constant between periods. The $2.1 million increase in research and development expenses primarily reflects the additional expenses associated with the phase 3 trial of ICT-107.
For the six months ended June 30, 2016, ImmunoCellular incurred a net loss of $11.0 million, or $0.12 per basic and diluted share, compared to a net loss of $4.6 million, or $0.05 per basic and diluted share, During the six months ended June 30, 2016, ImmunoCellular incurred $9.2 million in research and development expenses compared to $4.4 million in the prior year.
ImmunoCellular also reported that cash used in operations during the six months ended June 30, 2016 was $11.2 million compared to $6.9 million in the prior year. The increase primarily reflects that additional research and development expenditures in the current year. As of June 30, 2016, ImmunoCellular had $11.9 million in cash.
Subsequent to June 30, 2016, ImmunoCellular entered into an underwriting agreement with Maxim Group LLC, pursuant to which it sold 34,550,000 shares of common stock, pre-funded warrants to purchase 12,450,000 shares of ImmunoCellular’s common stock and base warrants to purchase 35,250,000 shares of its common stock. The common stock and base warrants were sold at a combined public offering price of $0.16, and the base warrants were approved for listing on the NYSE MKT under the symbol "IMUC.WS." The pre-funded warrants were sold to certain investors in lieu of common stock less the $0.01 per share exercise price for each pre-funded
warrant. The base warrants have an exercise price of $0.1921 per share. Additionally, ImmunoCellular granted the underwriters a 45 day option to purchase up to an additional 7,050,000 shares of common stock and/or base warrants to purchase 5,287,000 shares of its common stock. On August 12, 2016, the underwriters exercised the option to purchase 4,478,625 of additional base warrants at a price of $0.01266 per base warrant. The gross proceeds from the offering are approximately $7.5 million.
Additionally, the terms of the California Institute of Regenerative Medicine (CIRM) award were modified such that ImmunoCellular received an additional $1.5 million in July 2016 as part of the initial award received from CIRM. The total amount of the award and other award conditions remain unchanged.

As disclosed in its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016, on August 3, 2016, Momenta Pharmaceuticals, Inc. (the "Company") discontinued further accrual of its Part B, or Phase 2, portion of its Phase 1/2 clinical trial evaluating necuparanib in combination with nab-paclitaxel (ABRAXANE) and gemcitabine in patients with advanced metastatic pancreatic cancer. The decision to discontinue enrollment was based on the recommendation of the independent Data Safety Monitoring Board for the trial following the outcome of a planned interim futility analysis. On August 22, 2016, after confirming the results of the futility analysis and reviewing the unblinded safety and efficacy data and the results of various sensitivity and subgroup analyses, the Company decided to discontinue the necuparanib program.

On February 29, 2016, the Company filed with the Securities and Exchange Commission (the "Commission") a shelf registration statement on Form S-3 (File No. 333-209813) (the "Registration Statement"), which became immediately effective upon filing.

On September 1, 2016, the Company will be filing with the Commission a prospectus supplement, dated September 1, 2016, to the prospectus included in the Registration Statement in connection with the offer and sale of shares of the Company’s common stock from time to time through Stifel, Nicolaus & Company, Incorporated ("Stifel"), pursuant to an At-the-Market Equity Offering Sales Agreement, dated April 21, 2015, between the Company and Stifel, which was filed with the Commission as Exhibit 10.1 to the Company’s Current Report on Form 8-K on April 21, 2015.

In connection with the filing of the prospectus supplement, the Company is filing as Exhibit 5.1 hereto a copy of an opinion of its counsel, Latham & Watkins LLP, regarding the validity of the securities being registered under the prospectus supplement.

On August 19, 2016 Kancera reported results for Q2 2016 January 1 – June 30, 2016 (Press release, Kancera, AUG 19, 2016, View Source;releaseID=1182172 [SID:1234514645]).

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As a consequence of the acquisition of the subsidiary Kancera Förvaltning AB on 2016-06-16, the present Interim Report, Q2 2016, is prepared in accordance with IAS 34 and related parts of the Annual Accounts Act. The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the EU and the Swedish Annual Accounts Act. The accounting of the parent company has been prepared in accordance with the Annual Accounts Act and the Swedish Financial Reporting Board’s recommendation RFR 2, including a number of new or revised standards, interpretations and improvements adopted by the EU and apply from 1 January 2016. The transition to the new accounting standards was voluntary and did not affect the income statement or balance sheet for the period January 1 – March 31, 2016 accounted for using the previous principles, or the comparison figures used below in the comments from the previous year regarding the parent company Kancera AB (for comparison between the accounting policies, see Note 1).

The period January to March 2016 in brief

R&D expenses for the period amounted to SEK 8.7m (SEK 8.8m) of which the second quarter constituted SEK 4.4m (SEK 4.6m).
Operating income for the period amounted to SEK -10.5m (SEK -10.4m) of which the second quarter constituted SEK -5.5m (SEK -5.4m).
Income after financial items for the period amounted to SEK -10.5m (SEK -10.3m) of which the second quarter constituted SEK -5.5m (SEK -5.4m).
Earnings per share for the period were SEK -0.10 (SEK -0.10) of which the second quarter constituted SEK -0.05 (SEK -0.05).
Cash flow from operating activities for the period amounted to SEK -9.4m (SEK -10.9m) of which the second quarter constituted SEK -3.1m (SEK -5.8m).
Equity as of June 30, 2016 amounted to SEK 71.1m (SEK 31.2m) or SEK 0.68 (SEK 0.30) per share. The equity/assets ratio as of June 30, 2016 was 86 percent (76 percent).
Cash and cash equivalents as of June 30, 2016 amounted to SEK 68.7m (SEK 25.4m). Unpaid share issue expenses amount to approximately SEK 2.2m.
Significant events during the period

Kancera has from the 1st of January 2016 extended the lease of the company’s laboratories within the Karolinska Science Park for three years through an agreement with Humlegården Fastigheter.
Kancera has provided an update of the small molecule patent portfolio.
– A patent covering small molecule PFKFB3 inhibitors has been approved in the USA.

– A patent application covering new chemical series in the HDAC6 project has been filed.

– An international patent application covering ROR inhibitors has been strengthened by adding examples of additional highly potent ROR inhibitors.

Kancera reported that the company has developed a new series of ROR inhibitors that show improved pharmaceutical properties which will allow preclinical studies of their effect on e.g. solid tumors. These results have prompted Kancera to concentrate the investments in the ROR project to small molecule inhibitors and terminate the product development of a ROR-based vaccine. Furthermore, Kancera reported results from the Fractalkine project showing that KAN0440567 after oral administration to mice effectively blocks the function of the Fractalkine receptor.
Kancera announced that the company according to plan has received another payment of about SEK 2.8 million in January, 2016 from the EU for the A-PARADDISE project, which aims to develop drugs against parasitic diseases.
Kancera reported that ROR inhibitors have been tested against human triple negative breast cancer transferred to zebra fish. The experiments showed that Kancera’s small molecule ROR inhibitors are able to both reduce tumor size and metastases (spread) of this aggressive tumor form. Further, Kancera reported that the company´s PFKFB3 inhibitors are active in the same model of triple negative breast cancer and that a patent application has been filed covering the discovery that PFKFB3 inhibitors enhance the effect of radiation treatment.
Kancera reported that the Company due to positive efficacy data in disease models of cancer and pain has decided to exercise the exclusive option to acquire the Fractalkine project. The acquisition will be carried out in connection with the completion of the ongoing transfer of results and know-how from Acturum and AstraZeneca to Kancera. Payment for the project to Acturum Life Science AB will be made into three steps by a total of 6 million shares, of which the first payment is due at the submission of the application for authorization of a clinical trial after an approval by Kancera´s shareholders. In parallel, the company intends to validate a broader use of the drug candidate (KAN0440567) in order to demonstrate its full commercial potential.
With the authorization of the extraordinary general meeting on 22 April 2016, Kancera AB carried out an issue of units with preferential rights for the shareholders, as well as an issue of units in the form of over-allotment space through a separate directed share issue without preferential rights. The rights issue, which was fully subscribed in May 2016, concerned 20,785,072 units and an over-allotment space of 4,000,000 units consisting of one share and one warrant at a price of SEK 2.50 per unit. On top of this compensation to underwriters and financial advisors was added. After registration of the issuance of the over-allotment option and compensation to underwriters and financial advisors, the number of shares in Kancera AB amounts to 131,486,720 and the number of warrants to 27 561 356. The new issue has brought Kancera AB approximately SEK 61.9 million before issue costs. The issue assets will be used for Kancera’s drug development, clinical studies and the further development of the Company’s capacity to commercialize products. The majority of Kancera’s resources are now concentrated on taking at least one of Kancera’s drug candidates in the ROR and Fractalkine projects to clinical trial for chronic lymphocytic leukemia and pancreatic cancer, respectively. In parallel, the Company intends to validate a broader use of the drug candidates from these projects in order to demonstrate their full commercial potential.
Kancera provided the following operational update of the fractalkine and ROR projects:
– the Fractalkine antagonist KAN0440567 is able to eliminate pain resulting from inflammation of the pancreas. This type of pain is similar to the pain resulting from cancer in the pancreas and therefore these results support the continued development of KAN0440567 towards clinical trials against cancer.

– the ROR inhibitor KAN0439834 has been shown to effectively kill resistant cancer cells from the bone marrow of multiple myeloma (MM) patients. MM originates in the bone marrow and is an incurable chronic disease today. Further studies are now focused on translating these findings to effects in animal models of MM which will provide a basis for decisions on future clinical trials evaluating Kancera’s ROR inhibitors.

Kancera AB announced that VINNOVA has paid an additional SEK 358,451 to the HDAC6 project as part of the grant totaling SEK 2 million which has been designated by VINNOVA for the further development of Kancera’s HDAC6 inhibitors against cancer. This payment was made following the approval of Kancera’s third progress report for the project.
Kancera AB hereby announces that its subsidiary Kancera Förvaltning AB has been formed. The operations of the subsidiary include mainly financial management including Kancera’s stock option plan.
Significant events after the end of the reporting period

Kancera AB has not reported any significant events after the end of the period.

On August 18, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD), reported an update on the Company’s cash position and the recruitment progress in its two active clinical trials in IMP321 (Press release, Prima Biomed, AUG 18, 2016, View Source [SID:1234514637]).

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Financial Position
As a result of careful financial management, Prima remains in a solid financial position, with approximately A$20M cash as of 30 June 2016. Based on the Company’s forecasts, the current operational cash reach has been extended well into the fourth quarter of 2017.

Clinical Trial Updates: IMP321
The IMP321 clinical samples were the first biologic manufactured in China to receive regulatory approval for administration in clinical trials in Europe. Prima is pleased to advise that both IMP 321 clinical programs are progressing well.

TACTI-mel (Two ACTive Immunotherapeutics in melanoma), the Company’s Australian melanoma trial, now has six clinical centres approved, all of which have been activated. Three patients have been recruited in the first cohort and no dose limiting toxicity has been reached. The open label, Phase I study will recruit up to 24 patients, with the first data expected in the fourth quarter of 2016. Patients with unresectable or metastatic melanoma will be dosed with IMP321 in combination with an approved checkpoint inhibitor.

AIPAC (Active Immunotherapy PAClitaxel), has recruited three out of the nine patients expected to be enrolled in the second cohort of the trial’s safety run-in phase. As announced in June, data from the initial open-label run-in cohort of six patients, who received 6 mg doses of IMP321 in combination with paclitaxel, confirmed the safety, pharmacokinetics and pharmacodynamics of IMP321.

The results of all 15 patients from the safety run-in phase of AIPAC are expected in the fourth quarter of 2016.

On August 16, 2016 Immune Pharmaceuticals Inc. (NASDAQ:IMNP) ("Immune" or the "Company") reported financial results for the second quarter and six months ended June 30, 2016 as well as provided pipeline highlights and a business update (Press release, Immune Pharmaceuticals, AUG 18, 2016, View Source [SID:1234514638]).

"Immune has continued to make significant R&D and operational progress, while we seek to unlock the potential value of our pipeline through institutional financing and corporate transaction opportunities," said Dr. Daniel Teper, CEO of Immune Pharmaceuticals Inc.

Pipeline Highlights
Immuno-inflammation
· Bertilimumab continues to accrue patients in its two phase 2a clinical trials in bullous pemphigoid (BP) and ulcerative colitis (UC). The BP trial is expanding to six US centers in addition to the two Israeli centers. The first US center was initiated in August 2016 and started to screen patients with others to follow shortly. The UC trial is expanding to Eastern Europe with site initiations to be completed in the fourth quarter of 2016. An additional phase 2a trial in Atopic Dermatitis (AD) is in final planning stages in Canada.
· In the second quarter of 2016, new pre-clinical data was generated in AD and a new provisional patent was filed in partnership with Hadasit, the technology transfer of Hadassah hospital, for oral use of anti-eotaxin antibodies in Non-Alcoholic Steato-Hepatitis (NASH).
· Immune also advanced process development for its new cell line for the production of bertilimumab. Immune expects to bridge to the new cell line starting in mid-2017. Immune is assessing options for development of a sub-cutaneous formulation of bertilimumab.
· Immune advanced the development of NanoCyclo, a topical formulation of cyclosporine A for the potential treatment of AD and psoriasis. We are currently focused on the GMP manufacturing process and pre-clinical regulatory studies toward filing of an Investigational New Drug application in 2017.

Immuno-oncology
We are continuing to advance our plans to focus on our two clinical stage assets in oncology, Ceplene and Azixa and have made significant progress in the past quarter with both of these assets.
· Ceplene is approved in Europe for remission maintenance and prevention of relapse in adults with Acute Myeloid Leukemia (AML), an orphan indication with poor survival prognosis, for which no effective therapy is available to patients.
· Presented new positive biomarker driven clinical data from the European Phase IV study at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual meeting in New Orleans in April 2016. The phase IV RE:MISSION trial was designed to assess the immuno-modulatory properties of Ceplene/IL-2, and to correlate potential biomarkers with clinical outcome. Results indicated that outcomes were strongly predicted with a specific T-cell biomarker including leukemia-free survival (LFS) (HR 0.25, P=0.001) and overall survival (OS) (HR 0.24, P=0.009).
· Reported new data showing that Ceplene enhanced response to PD-1 and PD-L1 checkpoint inhibitors in lymphoma and solid tumor models. This data is supporting the provisional patent application filed in the first quarter of 2016 for use of Ceplene in combination with check point inhibitors.
· Presented new data at the Conference "Regulatory Myeloid Suppressor Cells: From Basic Discovery to Therapeutic Application" held in Philadelphia, PA providing further mechanistic evidence to explain the promising efficacy of Ceplene in combination with low dose IL-2 observed clinically in the myelomonocytic M4 and M5 AML subtypes in both Phase III and the recently completed Phase IV clinical trials.

· Immune now plans to leverage recent Ceplene/IL-2 data on predictive bio-markers and recent phase IV data results to design and reach an agreement with the FDA for a pivotal study in AML supporting a new drug application in the U.S.

· Azixa is a novel microtubule destabilizer that has a dual mode of action, acting as a vascular disrupting agent (VDA) and a potent cytotoxin with a unique ability to penetrate the blood brain barrier and reach high concentrations in the brain.
· Generated and reported new data demonstrating that the combination of Azixa and immune checkpoint inhibitors such as anti-CTLA-4 antibody resulted in enhanced activity compared to the activity elicited by the single agents alone.
· Filed a provisional patent application with the USPTO relating to the combination of Azixa and immune checkpoint inhibitors such as an anti-CTLA-4 antibody and anti-PD1 monoclonal antibodies in the treatment of cancer.

Business Update
On July 18, 2016, the Company signed an amendment to the May 15, 2016 Option Agreement with Novel Pain Therapeutics, LLC (NPT), a syndicate of experienced healthcare investors. Immune agreed to designate a subsidiary that will hold all of the Intellectual Property for Immune’s pain assets (Amiket, Amiket Nano and LidoPain). Under the terms of the Amended Option Agreement, the parties have agreed to a pre-money valuation of $15 million for Immune’s equity stake in the pain subsidiary with a target closing date of September 15, 2016 for the first tranche of dedicated financing by NPT and other investors. In addition, subject to the exercise of the Option Agreement and the execution of the definitive License Agreement, as well as the ultimate development, sale and/or licensing of the products, Immune will be eligible to receive up to $145 million in milestone payments as well as sublicensing fees and royalties.

Second Quarter and Six Months Ended June 30, 2016 Financial Discussion
Immune reported a loss attributable to common stockholders of $5.7 million, or $0.13 per share, for the quarter ended June 30, 2016, compared to a loss attributable to common stockholders of $2.9 million, or $0.12 per share, for the quarter ended June 30, 2015. For the six months ended June 30, 2016, Immune reported a loss attributable to common stockholders of $11.7 million, or $0.30 per share, compared to a loss attributable to common stockholders of $8.2 million, or $0.34 per share, for the six months ended June 30, 2015.

Research and Development ("R&D") expenses increased by $0.8 million during the quarter ended June 30, 2016 to $1.9 million compared with $1.1 million during the quarter ended June 30, 2015. For the six months ended June 30, 2016 R&D expenses increased by $1.7 million to $4.0 million from $2.3 million. The increase in R&D expenses for the quarter and six months ended June 30, 2016 was primarily driven by higher salaries, employee benefits and share-based compensation as a result of higher R&D headcount. In addition, the increase in R&D expenses was driven by higher clinical trial expenses as the Company continues to ramp up its clinical trials related to bertilimumab in both BP and UC.

General and Administrative ("G&A") expenses decreased $0.8 million during the quarter ended June 30, 2016 to $0.9 million compared with $1.7 million during the quarter ended June 30, 2015, due to lower share based compensation expense and lower consulting and business development expenses. For the six months ended June 30, 2016 G&A expenses decreased by $0.6 million to $3.4 million from $4.0 million during the six months ended June 30, 2015 primarily due to lower share based compensation expense and lower legal fees.

Non-operating expense was $0.7 million during the three months ended June 30, 2016 compared with non-operating expense of $0.1 million during the three months ended June 30, 2015. For the six months ended June 30, 2016, non-operating expense was $1.4 million compared with $0.2 million for the six months ended June 30, 2015. Non-operating expense increased for the three and six months ended June 30, 2016 primarily relating to cash interest expense and amortization of debt issuance costs for the Company’s loan agreement and the loss on the change in fair value of derivative liability instrument.

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