On May 15, 2017 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) reported that the Company presented in oral session significant data on Selective Anti-SIRP a OSE-172 (Effi-DEM), at the "2 nd Annual Advances in Immuno-Oncology Congress" in London on May 15, 2017 (Press release, OSE Immunotherapeutics, MAY 15, 2017, View Source [SID1234519637]).

OSE-172 (Effi-DEM) is a humanized monoclonal antibody targeting SIRPa, expressed on suppressive myeloid cells (Myeloid Derived Suppressor Cells, MDSC and Tumor Associated Macrophages, TAM) as well as effector myeloid cells (anti-tumoral macrophages) involved in the Tumor Micro-Environment. As a selective antagonist of SIRPa, OSE-172 promotes recruitment of effector over suppressive myeloid cells, in particular it inhibits M 2 pro-tumorigenic macrophage cells and increases M1 anti-tumorigenic cells, whilst increasing effector memory CD8 T-cells resurrecting key immune defenses.

OSE-172 does not bind to red blood cells and platelets constituting a potential hematologic safety advantage. Moreover OSE-172 i s very selective as it antagonizes SIRPa and does not bind human T-cells (no SIRP- binding, receptor of the SIRP famil y expressed on T-cells), allow ing for a strong human effector T cell proliferation in parallel with a blockade of suppressive myeloid cells. This original mechanism of action provides reduction of tumor growth in various solid tumor models through a straight transformation in the Tumor Micro-Environment: When used as monotherapy or com bined with activators of the T-cell response, anti-PD-L1 (checkpoint inhibitor) and anti-41BB (costimulatory receptor), OSE-172 was very effective allowing effector macrophages and T-cells to work together with significant tumor shrinkage. In parallel with the transformation of suppressive into effector myeloid cells, T umor Micro-Environment was also dramatically modified allowing i ntra-tumoral accumulation of cytolytic natural killer (NK) and of effector B cells. A particular interest is a significant decrease of peripheral regulatory T-cells (suppressive Treg s). " Our myeloid checkpoint inhibitor OSE-172 demonstrate s its strong impact on the Tumor Micro-Environment beyond myeloid cells, tackling cancer through a specific blockade of SIRPa," said Nicolas Poirier, Chief Scientific Officer of OSE Immunotherapeutics. FOR MORE INFOR M ATION ON 2ND ANNUAL ADVANCES IN IMMUNO-ONCOLOGY C ONGRESS View Source 15-16 May 2017, London Session: Discove ry of Immuno-Oncology Therapies: Selective Anti-SIRPa: Next Generation Checkpoint Inhibitor Targeting Pro-Tumors And Suppressors Myeloid Cells Nicolas Poirier, Ph.D., C S O, OSE Immunotherapeutics

On May 15, 2017 Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a late stage clinical biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases, today reported first quarter financial results and key corporate highlights (Press release, Sophiris Bio, MAY 15, 2017, View Source [SID1234519162]).

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Key Corporate Highlights:

Update on Phase 2b Localized Prostate Cancer Study. In March 2017, the Company initiated its Phase 2b open-label localized prostate cancer study with investigational sites in both the UK and US. Five clinical trial sites have been initiated and additional sites are in the process of being initiated.

The Company is currently awaiting final regulatory clearance for the diluent (the medium in which topsalysin is diluted prior to dosing), which is anticipated this month, at which point the investigational sites will begin dosing patients.

The Company expects to receive the six-month biopsy data for all patients in the first quarter of 2018 assuming enrollment is completed as expected. The Company expects to have complete data on all patients who receive a second dose by the fourth quarter of 2018.

Presented Proof-of-Concept and Phase 2a Data at Global Urological Meetings. The Company presented positive data from its Phase 2a clinical trial of topsalysin for the focal treatment of localized prostate cancer at the 112th American Urological Association Annual Meeting and at the 32nd European Association of Urology Congress. Copies of the posters are available on the Company’s website at www.sophirisbio.com.

“We now have five clinical trial sites fully trained with additional sites coming onboard,” said Randall E. Woods, president and CEO of Sophiris. “The regulatory approval of the diluent is the last remaining box to check in the administrative work that enables the dosing of patients which we anticipate being able to do in the very near future.”

Financial Results:

At March 31, 2017, the Company had cash, cash equivalents and securities available-for-sale of $25.7 million and working capital of $25.6 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations through the end of 2018. The Company is currently not planning on pursuing a second Phase 3 trial in BPH, unless the Company can secure a development partner to fund a new clinical trial or the Company obtains other financing.

The Company reported a net loss of $2.6 million ($0.09 per share) for the three months ended March 31, 2017 compared to a net loss of $2.2 million ($0.13 per share) for the three months ended March 31, 2016.

Research and development expenses were $1.2 million for the three months ended March 31, 2017, compared to $0.9 million for the three months ended March 31, 2016. The increase in research and development expenses was primarily attributable to an increase in the costs associated with the Company’s on-going Phase 2b clinical trial for the focal treatment of localized prostate cancer which was initiated in March 2017 and, to a lesser extent, an increase in costs associated with manufacturing activities for topsalysin. These increases were partially offset by a decrease in costs associated with our completed Phase 2a proof of concept clinical trial for low to intermediate risk prostate cancer.

General and administrative expenses were $1.4 million for the three months ended March 31, 2017 compared to $1.2 million for the three months ended March 31, 2016. The increase in general and administrative expenses was primarily due to an increase in non-cash stock-based compensation expense which was offset by a reduction in legal and professional services.

On May 15, 2017 Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection reported financial results for the three months ended March 31, 2017 (Press release, Aeolus, MAY 15, 2017, View Source [SID1234519167]).

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The company reported net loss of $1,035,000 or $0.01 per share for the three months ended March 31, 2017. This compares to a net loss (before extraordinary items) of $629,000 or $0.01 per share for the three months ended March 31, 2016. The increase in net loss was primarily attributable to pre-IND work on AEOL 11114, the Company’s compound in development for the treatment of Parkinson’s disease and lower revenues from the Biomedical Advanced Research and Development Authority ("BARDA").

"During the quarter, we initiated a Phase 1 safety study of AEOL 10150 in healthy volunteers, completed manufacturing optimization and oral formulation development work on AEOL 11114 for Parkinson’s disease, and reported positive results in an animal model of Cystic Fibrosis with inhaled AEOL 20415," stated John L. McManus, President and Chief Executive Officer. "Although we were disappointed with BARDA’s notification in March that it had elected not to exercise additional options under the contract at this time, we are continuing work in process under the contract through its expiration in May 2019. In addition, we are submitting proposals to and have received indications of interest from other government agencies to expand the funding of AEOL 10150 as a medical countermeasure against the pulmonary effects of radiation exposure and sulfur mustard gas exposure."

Results of Operations for the Three Months Ended March 31, 2017

Revenue for the three months ended March 31, 2017 was $129,000, which compares to $565,000 for the three months ended March 31, 2016. The revenue is from the BARDA Contract and the decline in revenue is primarily attributable to a lower level of activity under that contract.

Research and Development ("R&D") expenses increased $93,000, or 19%, to $594,000 for the three months ended March 31, 2017 from $501,000 for the three months ended March 31, 2016. The increase is primarily attributable to manufacturing optimization and oral formulation development work for AEOL 11114.

General and administrative ("G&A") expenses decreased $123,000, or 18%, to $570,000 for the three months ended March 31, 2017 from $693,000 for the three months ended March 31, 2016. The decrease is primarily attributable to lower accounting and legal fees related to SEC filing requirements.

Results of Operations for the Six Months Ended March 31, 2017

Revenue for the six months ended March 31, 2017 was $212,000, which compares to $870,000 for the six months ended March 31, 2016. The revenue is from the BARDA Contract and the decline in revenue is primarily attributable to a lower level of activity under that contract.

Research and Development ("R&D") expenses increased $89,000, or 9%, to $1,082,000 for the six months ended March 31, 2017 from $993,000 for the six months ended March 31, 2016. The increase is primarily attributable to manufacturing optimization and oral formulation development work for AEOL 11114.

General and administrative ("G&A") expenses decreased $2,000 to $1,252,000 for the six months ended March 31, 2017 from $1,254,000 for the six months ended March 31, 2016. The decrease is primarily attributable to lower investor relations fees.

As of March 31, 2017, the Company had approximately $981,000 in cash and cash equivalents and 152,085,825 common shares outstanding. The Company had accounts receivable of $603,000 and accounts payable of $638,000 on March 31, 2017.

Aeolus has filed today with the SEC its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. Aeolus urges its investors to read this quarterly filing as well as its Annual Report on Form 10-K, also filed with the SEC, for further details concerning the Company. The Quarterly Report on Form 10-Q and the Annual Report on Form 10-K are also available on the Company’s website, at www.aolsrx.com.

About AEOL 10150

AEOL 10150 is a superoxide dismutase (SOD) mimic being developed for the treatment/mitigation of lung damage from exposure to chemical and radiological insults and to reduce/prevent lung damage in patients with Idiopathic Pulmonary Fibrosis (IPF) and in cancer patients receiving radiation therapy. AEOL 10150 protects tissue from damage and increases survival in animal models of lung damage after exposure to radiation toxic chemicals, agents that induce inflammation, and trauma by mitigating and/or preventing cell death, inflammation and fibrosis through its action on oxidative stress (Reactive Oxygen Species, or "ROS") and regulation of growth factors and chemokines including PTEN, TGF-β1, HIF-1α, TNF-α and IL-6, as well as impacting subsequent signaling pathways associated with ROS production, apoptosis and fibrosis such as NADPH-oxidase (Nox-4), PTEN, PI3K/p-Akt and p53/Bax. AEOL 10150 has been shown to improve survival and mitigate pulmonary damage in rodent models of SMG, chlorine gas and radiation exposure and in a nonhuman primate (NHP) model of whole thorax lung irradiation (WTLI). Given these promising results, Aeolus is developing AEOL10150 for the mitigation and/or treatment of pulmonary injury resulting from SMG exposure.

AEOL 10150 has performed well in animal safety studies, was well tolerated in two human clinical trials and is currently being tested in a third human study. Aeolus has received "Orphan Drug" designation for use in treating Lung ARS, Idiopathic Pulmonary Fibrosis and Amyotrophic Lateral Sclerosis and has active IND’s for the Lung ARS and ALS indications. Preparations are currently underway to make IND filings for Idiopathic Pulmonary Fibrosis, Cancer Radiation Therapy and Pulmonary Effects of Sulfur Mustard Gas Exposure.