On May 16, 2016 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, 2016 (Press release, Aeolus, MAY 16, 2016, View Source [SID:1234512438]). The Company also announced a conference call to update investors on its development programs, including its partnership with the Biomedical Advanced Research and Development Authority ("BARDA") for the development of AEOL-10150 ("10150") as treatment for the pulmonary and delayed effects of acute radiation exposure ("Lung-ARS").

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Investor Update Call Information:

Date: Thursday, May 19 th , 2016

Time: 11:00 AM EDT/8:00 AM PDT

Dial-in Number: (844) 784-2549

International Dial-in: (661) 378-9785

A recording of the conference call will be available on the Company’s website, www.aolsrx.com, for 28 days following the call.

The Company reported a net loss of approximately $2,535,000, or $0.02 per share for the three months ended March 31, 2016. This compares to a net loss of $1,033,000, or $0.01 per share, for the three months ended December 31, 2015. The increase in net loss was primarily attributable to a $1,906,000 non-cash expense related to a deemed dividend for the Company’s Series C Preferred Stock. The net operating loss for the period was $629,000 or $0.00 per share.

"During the quarter, the U.S Food and Drug Administration ("FDA") removed the clinical hold on our Investigational New Drug Application ("IND") for 10150 to treat Lung-ARS," stated John L. McManus, President and Chief Executive Officer. "We are in discussions with our development partner, BARDA, regarding the appropriate clinical studies to generate the human safety data required for a pre-Emergency Use Authorization filing and, ultimately, for an approval under the FDA’s ‘Animal Rule.’ We are not aware of any other compounds in advanced development for Lung-ARS or any compounds that have demonstrated efficacy when administered after radiation exposure. In addition, we are preparing to meet with the FDA to discuss the filing of INDs for human studies in Idiopathic Pulmonary Fibrosis and Cancer Radiation Therapy. We hope to initiate these studies in the second half of 2016."

Key Operational Accomplishments During the Quarter:

FDA removed the clinical hold on AEOL 10150 for studies in healthy volunteers supporting the Lung-ARS program
Preparation of IND submissions to the FDA for later this year for studies of AEOL 10150 in patients with Idiopathic Pulmonary Fibrosis and in patients receiving radiation therapy for cancer
Patent for AEOL 11114 issued in Europe and allowed in Japan
IND-enabling work for AEOL 11114 in Parkinson’s Disease initiated with a filing expected in 2017
Animal study of AEOL 20415 (an new, novel anti-infective) initiated as a treatment for infections in patients with Cystic Fibrosis with results expected in the second quarter
BARDA contract modification executed to extend stability testing on AEOL 10150 bulk drug and final drug product for 3 additional years
Results of Operations for the Three Months Ended March 31, 2016

Revenue for the three months ended March 31, 2016 was approximately $565,000, versus revenue of $1,189,000 for the three months ended March 31, 2015. The revenue is from the Lung ARS medical countermeasure development contract with BARDA, a division of the U.S. Department of Health and Human Services. Lower revenue in 2016 reflects the timing of the initiation of program items and revenue recognition under accounting rules.

Research and development expenses decreased to approximately $501,000 for the three months ended March 31, 2016, from approximately $1,297,000 for the three months ended March 31, 2015. The decrease in 2016 expenses reflects both the timing of program items under the BARDA contract and expense recognition under accounting rules.

General and administrative expenses were approximately $693,000 for the three months ended March 31, 2016 compared to approximately $604,000 for the three months ended March 31, 2015.

Results of Operations for the Six Months Ended March 31, 2016

Revenue for the six months ended March 31, 2016 was approximately $870,000, versus revenue of $2,114,000 for the six months ended March 31, 2015. The revenue is from the Lung ARS medical countermeasure development contract with BARDA. Lower revenue in 2016 reflects the timing of the initiation of program items and revenue recognition under accounting rules.

Research and development expenses decreased to approximately $993,000 for the six months ended March 31, 2016, from approximately $2,270,000 for the six months ended March 31, 2015. The decrease in 2016 expenses reflects both the timing of program items under the BARDA contract and expense recognition under accounting rules.

General and administrative expenses were approximately $1,254,000 for the six months ended March 31, 2016 compared to approximately $1,254,000 for the six months ended March 31, 2015.

As of March 31, 2016, the Company had approximately $4,509,000 in cash and cash equivalents and 151,559,745 common shares outstanding. The Company had accounts receivable of $1,366,000 and accounts payable of $1,031,000 on March 31, 2016.

Aeolus has filed today with the SEC its Quarterly Report on Form 10-Q for the quarter ended March 31, 2016. 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 broad-spectrum catalytic antioxidant specifically designed to neutralize reactive oxygen and nitrogen species. The neutralization of these species reduces oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure. AEOL 10150 may have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation in the treatment of oncology.

AEOL 10150 has performed well in animal safety studies, was well tolerated in two human clinical trials and has demonstrated statistically significant survival efficacy in multiple Radiation-Induced Lung Fibrosis ("Lung ARS") studies in animals. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event. Aeolus has received "Orphan Drug" designation for the use of AEOL 10150 in treating Lung ARS and Idiopathic Pulmonary Fibrosis and has filed an IND to allow for human safety testing of the compound in healthy volunteers. AEOL 10150 is also currently in development for use in Idiopathic Pulmonary Fibrosis and as both a therapeutic and prophylactic drug in cancer patients.

On May 16, 2016 Diffusion Pharmaceuticals Inc. (OTCQX: DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer, reported financial results for the first quarter ended March 31, 2016 and provided an overview of recent corporate highlights (Filing, Q1, RestorGenex, 2016, MAY 16, 2016, View Source [SID:1234512489]). The quarterly results will be filed shortly on Form 10-Q with the SEC.

David Kalergis, Chairman and Chief Executive Officer of Diffusion, said, "We are pleased with the direction that we are heading following the merger with RestorGenex Corporation. We are continuing to expand our team and welcomed Tom Byrne as General Counsel. We also continue to advance our plan to expand the clinical development pipeline for TSC from GBM to first line pancreatic cancer."

Corporate Highlights

In January 2016, Diffusion Pharmaceuticals LLC completed a reverse merger with RestorGenex Corporation in an all-stock transaction. Following the close of the reverse merger, RestorGenex was renamed Diffusion Pharmaceuticals Inc. and its ticker symbol was changed to "DFFN".

In April 2016, Thomas Byrne joined Diffusion as General Counsel and transitioned from his prior positon on the Board of Directors. Mr. Byrne is continuing to oversee Diffusion’s intellectual property strategy, which he has directed since Diffusion was founded in 2001.

First Quarter 2016 Results

Research and development expenses were $2.4 million for the quarter ended March 31, 2016, compared to $732,000 for the quarter ended March 31, 2015. This increase was primarily a result of an increase in drug manufacturing costs and initiating the TSC pancreatic cancer program.

General and administrative expenses were $3.9 million for the quarter ended March 31, 2016, compared to $459,000 for the quarter ended March 31, 2015. The increase was attributed to costs associated with the merger and operating as a public company, including corporate insurance, professional fees and financial reporting fees.

Net loss was $6.2 million for the quarter ended March 31, 2016, compared to a net loss of $1.2 million for the quarter ended March 31, 2015. The increase in the net loss was due primarily to higher expenses associated with the increased research and development expenses, and general and administrative expenses summarized above.

Cash and cash equivalents were $5.9 million for the quarter ended March 31, 2016, compared to $2.0 million for quarter ended March 31, 2015.

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On May 16, 2016 Transgenomic, Inc. (NASDAQ:TBIO), reported new concordance study data confirming the superior performance of its ICE COLD-PCR (ICP) enrichment technology over standard biopsied tissue PCR results for detection of tumor mutations in cancer patients (Press release, Transgenomic, MAY 16, 2016, View Source [SID:1234512439]). The data show that plasma-based liquid biopsy testing using ICP is 100% concordant with an established approach that uses standard PCR. The matched patient data further indicate that the ICP-enabled liquid biopsies detected more tumor mutations than tissue biopsy testing using standard PCR. Transgenomic is in the process of submitting the study to a peer-reviewed scientific publication.

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The concordance study was reviewed by Anil Vachani, MD, MS, Associate Professor of Medicine at the Hospital of the University of Pennsylvania and the Veteran’s Administration Medical Center, and a Director of Clinical Research at the University of Pennsylvania Perelman School of Medicine. Dr. Vachani’s research includes the study of methods to optimize the use of targeted cancer therapies. Dr. Vachani noted, "High sensitivity detection of genetic biomarkers from cell free DNA has the potential to provide guidance to clinical oncologists for personalized, precision cancer treatment. Liquid biopsies are a source of genetic information when there is no available tumor tissue and they make it possible to monitor treatment effectiveness and the emergence of drug resistance on an ongoing basis, thereby enabling more effective real-time treatment decisions. This can be critical for patients with metastatic disease. Based on these initial encouraging results, ICP may be a useful technology for helping to facilitate the broad use of cell free DNA liquid biopsies in cancer. I look forward to seeing the results of further confirmatory studies now underway."

In this study, Transgenomic analyzed 22 matched samples from chemo-naïve late-stage colorectal cancer (CRC) patients. The purpose was to compare the concordance between tissue biopsy results using traditional PCR and Sanger sequencing with plasma liquid biopsy results obtained using ICE COLD-PCR and Sanger sequencing. The study also compared mutation detection results from the matched tissue/FFPE samples analyzed with Sanger sequencing and either standard PCR or ICE COLD-PCR.

The concordance between the conventional tumor biopsy results and the matched ICP-enriched plasma sample liquid biopsy results was 100%. In addition, the ICP-enriched biopsies identified seven mutations missed by the conventional PCR approach–four additional mutations were identified in the ICP-enriched plasma samples and three additional mutations were identified in tissue samples that were analyzed with ICE COLD-PCR.

Transgenomic President and CEO Paul Kinnon commented, "We are delighted with the latest results from our studies, which show 100% concordance between ICE COLD-PCR-based liquid biopsy results and tissue-based results from the same patients, as well as ICP’s superior performance in identifying tumor mutations that were missed by conventional PCR methods. This new data further validates the clinical utility of ICP as a robust method to detect and monitor actionable mutations from a liquid biopsy sample, an essential component needed for adoption of precision medicine. We expect to submit additional data to peer reviewed scientific settings in the coming months."

Transgenomic’s ICP cancer assays exponentially amplify targeted regions of exons that have been determined to be predictive and/or prognostic for many types of cancer, including colorectal cancer, melanoma, breast cancer and non-small cell lung cancer. The 17-target mutation panel matches the set of mutation data currently used routinely in clinical settings for identifying and selecting therapeutic or clinical trial options for patients being treated for multiple cancer types. Additional mutations are being added as the science advances.

ICE COLD-PCR achieves its ultra-high sensitivity through selective amplification of mutant DNA. The result is up to a 500-fold increase in sensitivity in identifying mutations with the most precise sequence alteration detection rates available. ICP was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.

Oncbiomune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, OncBioMune Pharmaceuticals, 2017, MAY 16, 2016, View Source [SID1234522122]).

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On May 16, 2016 Abeona Therapeutics Inc. (NASDAQ: ABEO), a clinical-stage biopharmaceutical company focused on developing and delivering gene therapy and plasma-based products for severe and life-threatening rare diseases, reported summary financial results for the first quarter (Press release, Abeona Therapeutics, MAY 16, 2016, View Source;p=RssLanding&cat=news&id=2168743 [SID:1234512440]). The Company will provide a business update for investors and other stakeholders on a conference call, Tuesday, May 17th, at 10 am (Eastern). Tim Miller, Ph.D., President and Chief Executive Officer and Jeffrey Davis, Chief Operating Officer, together with other executives, will conduct the call. Interested parties are invited to participate in the call by dialing 877-269-7756 (toll free domestic) or 201-689-7817 (international). The call will consist of an overview of the Company’s 1Q16 financials, and a discussion of business highlights.

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"The first quarter of this year has led to significant advancements in our goal of building a leadership position in the field of gene therapy and plasma protein therapies for rare diseases," stated Steven H. Rouhandeh, Executive Chairman. "We thank our collaborators, shareholders and staff as we prepare to launch human clinical trials in up to four different rare diseases over the next 12 months."

Tim Miller, PhD, stated, "In the first quarter, Abeona hit important regulatory milestones with the FDA allowance of our Phase 1/2 clinical study in Sanfilippo syndrome type A (MPS IIIA) and the European approvals of the Genetically Modified Organisms (GMO) and Ethical Committee (CEIC) regulatory filings. Additionally, Abeona and its academic collaborators presented meaningful pre-clinical data at the World Symposium of Lysosomal Storage Diseases in San Diego, and on its proprietary CRISPR/Cas9 platform at the 2nd Annual CRISPR Precision Gene Editing Congress in Boston, MA."

Recent Abeona Operating Highlights

The Interministerial Council of Genetically Modified Organisms has approved the Genetically Modified Organism (GMO) Voluntary Release and Ethical Committee (CEIC) regulatory filings for both Phase 1/2 Gene Therapy Clinical Studies to treat patients with AB0-101 (AAV NAGLU) and ABO-102 (AAV SGSH) for patients with Sanfilippo syndrome type A (MPS IIIA) or type B (MPS IIIB)
FDA allowed an Investigational New Drug (IND) for Systemic AAV Phase 1/2 Clinical Study With ABO-102 Gene Therapy for Patients With Sanfilippo Syndrome Type A (MPS IIIA)
Abeona highlighted new preclinical Juvenile Neuronal Ceroid Lipofuscinosis (JNCL) data at WORLDSymposium() 2016 which demonstrated encouraging in vivo efficacy in preclinical JNCL (also known as Juvenile Batten disease) model
Abeona partnered with Therapure Biopharma to continue its efforts in developing rare plasma proteins in SDF Alpha for inherited COPD
Abeona presented compelling data at the 2nd Annual CRISPR Precision Gene Editing Congress in Boston, MA which showed that CRISPR/Cas9 gene repair resulted in normalization of the FANCC gene in Fanconi anemia (FA)
First Quarter Summary Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2016 were $37.4 million, compared to $40.1 million as of December 31, 2015. Net cash used in operating activities in 1Q16 was $2.5 million as compared to $3.2 million in the same period in 2015, a decrease of $647 thousand.
Revenues: Revenues were $235 thousand for the first quarter of 2016, compared to $258 thousand in in the first quarter of 2015. Revenues consisted of a combination of royalties from marketed products, primarily MuGard, and recognition of deferred revenues related to upfront payments from early license agreements.
Loss per share: Loss per share was $0.17 for the first quarter of 2016, compared to a loss per share of $0.10 in comparable period in 2015.