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 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 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, reported financial results for the three months ended March 31, 2016 (Filing, Q1, Sophiris Bio, 2016, MAY 16, 2016, View Source [SID:1234512460]).

Business Highlights:

● On May 12, 2016, the Company announced the engagement Oppenheimer & Co. Inc. as its financial advisor to assist with the evaluation of various strategic alternatives.

● On May 11, 2016, the Company announced the closing of a public offering of common shares and warrants in which the Company raised net proceeds of $4.6 million.

● On May 7, 2016, the Company presented positive data from its Phase 3 clinical trial of topsalysin as a treatment for the symptoms of benign prostatic hyperplasia ("BPH") as a late breaking poster at the 111th American Urological Association Annual Meeting. A copy of the poster is available on the Company’s website at www.sophirisbio.com.

● On January 28, 2016, the Company announced that a review of the 6-month biopsy data from the first seven patients in the localized prostate cancer trial was completed.

"We are encouraged by the interim data from our Phase 2a topsalysin proof of concept trial for the treatment of localized prostate cancer announced earlier this year, and remain on track to complete this clinical trial by the end of this quarter," stated Randall Woods, president and CEO of Sophiris Bio. "We believe that the positive data from our Phase 3 BPH clinical trial and the encouraging initial data from our localized prostate cancer clinical trial further de-risk the development programs."

Mr. Woods added: "The funds raised in the financing strengthen our balance sheet as we review various strategic alternatives to advance the clinical development of topsalysin and create value for shareholders."

Phase 2a Proof of Concept Clinical Trial for Localized Prostate Cancer:

In May 2015 we initiated a single-center, open-label Phase 2a proof of concept clinical trial ("POC trial") of topsalysin for the treatment of localized low to intermediate risk prostate cancer. We believe that the highly targeted mechanism by which topsalysin selectively destroys prostate tissue in BPH makes topsalysin a potential targeted focal treatment for localized prostate cancer. A total of 18 patients with clinically significant, localized low to intermediate risk prostate cancer have been enrolled in this ongoing POC trial.

On January 28, 2016 we announced the biopsy data at six months on the first seven patients to complete the POC trial. A review of the biopsy data from the first seven patients showed that four patients experienced a response to treatment, including: one patient who experienced complete ablation of the tumor where there was no evidence of the treated tumor on a targeted biopsy at six months following treatment; and three patients who experienced either a reduction in the maximum cancer core length or a reduction in the Gleason pattern. Three patients had no response to treatment. No serious adverse events have been observed to date in this clinical trial and no new safety signals have been reported. We expect to have final data on all 18 patients by the end of the second quarter of 2016.

Financial Results:

At March 31, 2016, we had cash, cash equivalents and securities available-for-sale of $5.4 million and net working capital of $3.0 million. Taking into consideration the net proceeds of $4.6 million from our financing completed on May 11, 2016, we now expect that our cash, cash equivalents and securities available-for-sale will be sufficient to fund our operations for at least the next twelve months assuming that we do not initiate any additional clinical development of topsalysin beyond our on-going Phase 2a POC trial. We will need to obtain additional capital to fund a second Phase 3 clinical trial of topsalysin for the treatment of the symptoms of BPH and for any future clinical development of topsalysin for the treatment of localized prostate cancer and to fund our ongoing operations. We are actively evaluating strategic alternatives, including potential partnering arrangements, financings or a strategic transaction. We expect our research and development expense and general and administrative expenses to decrease as a result of the completion of our Phase 2a POC trial at the end of the second quarter of 2016 and as a result of the layoff of five of our ten employees during May 2016, resulting in an annualized reduction in compensation and benefit expenses of $0.9 million, net of severance. As of March 31, 2016, the outstanding principal balance of our term loan was $4.8 million on which we make principal and interest payments monthly.

The Company reported a net loss of $2.2 million ($0.13 per share) for the three months ended March 31, 2016 compared to a net loss of $4.3 million ($0.26 per share) for the three months ended March 31, 2015.

Research and development expenses

Research and development expenses were $0.9 million for the three months ended March 31, 2016 compared to $3.1 million for the three months ended March 31, 2015. The decrease in research and development costs is attributable to decreases in the costs associated with the Company’s completed Phase 3 PLUS-1 clinical trial of topsalysin, costs associated with the manufacturing activities for topsalysin and personnel related costs. These decreases are partially offset by an increase in costs associated with the Phase 2a POC trial for localized low to intermediate risk prostate cancer which enrolled its first patient in the second quarter of 2015.

General and administrative expenses

General and administrative expenses were $1.2 million for the three months ended March 31, 2016 compared to $1.0 million for the three months ended March 31, 2015. The increase is primarily due to increases in legal, accounting and professional services costs.

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On May 16, 2016 Immune Pharmaceuticals Inc. (NASDAQ:IMNP) ("Immune" or the "Company") reported financial results for the first quarter ended March 31, 2016 (Filing, Q1, Immune Pharmaceuticals, 2016, MAY 16, 2016, View Source [SID:1234512455]).

Business and Research & Development ("R&D") Update

Immune continues to pursue its strategy to unlock the value of its diversified pipeline through the financing and strategic partnering of specifically focused asset groups:
· Immuno-inflammation focus on gastro-enterology and dermatology through a pipeline comprised of two assets: bertilimumab, currently in two phase II clinical trials in ulcerative colitis and bullous pemphigoid with a third phase II planned in severe atopic dermatitis, and topical nano-formulated cyclosporine for the treatment of atopic dermatitis and psoriasis.
· Immuno-oncology subsidiary that includes three mid-to-late stage clinical assets (Ceplene, Azixa, Crolibulin) as well as novel platforms: bispecific antibodies and NanomAbs , antibody nanoparticle conjugates.
· The licensing of AmiKet and AmiKet Nano for the treatment of peripheral neuropathic pain to a newly-created pain specialty pharma company:
v Immune executed an exclusive 60-day option with Novel Pain Therapeutics ("NPT") to enter into a worldwide license agreement for AmiKet and AmiKet Nano for the treatment of peripheral neuropathic pain. Upon execution of the license agreement pursuant to agreed material terms in the option, NPT will assume all research and development costs and Immune will be eligible to receive up to $160 million, comprised of an upfront fee of at least $15 million in the form of equity in NPT, up to $25 million in development milestones, and up to $120 million in commercial milestones, as well as product sales royalties. Immune will also be eligible to receive 25% and up to 50% of sublicense fees received by NPT.

Immune continues to execute its R&D plan with progress for all its key assets:
· Continued enrollment into the two Phase II clinical trials with bertilimumab.
· Publication in Oncotarget and presentation at the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) meeting of European phase IV studies highlighting predictive bio-markers of overall survival in maintenance of first remission in patients with acute myeloid leukemia. Immune intends to submit to the Food and Drug Administration a plan for a pivotal overall survival study with Ceplene in combination with low dose IL-2 (Proleukin).
· On-going development and testing of new bi-specific antibodies targeting PD-1 and OX40 (two immune check points) and PDL-1 and BCMA (an immune check point and a tumor marker of multiple myeloma).
· On-going development of topical nano-formulated cyclosporine toward an investigational new drug application and initiation of 505(b) 2 clinical development.

"We are structuring the Company strategically to ensure long term comprehensive financing of our product pipeline and enable focused execution" said Dr. Daniel Teper, CEO of Immune Pharmaceuticals Inc. "We continue to progress in our clinical trials with bertilimumab as we increase patient enrollment and we are on track to achieve our operational and financial objectives for 2016."

First Quarter 2016 Financial Results
Immune reported a loss attributable to common stockholders of $6.0 million, or $0.17 per share, for the quarter ended March 31, 2016, compared to a loss attributable to common stockholders of $3.6 million, or $0.15 per share, for the quarter ended March 31, 2015.

R&D expenses increased by $0.9 million, due to higher salaries and employee benefits, license fees and clinical trial expenses. Salaries and employee benefits increased due to higher R&D employee head count for the three months ended March 31, 2016 compared with the three months ended March 31, 2015. G&A expenses increased by $0.1 million due to higher salaries and rent expense partially offset by lower professional fees.

Non-operating expense was $0.7 million during the three months ended March 31, 2016 compared with non-operating expense of $0.1 million during the three months ended March 31, 2015, an increase of $0.6 million which is primarily due to higher interest expense and derivative liability expense.

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On May 16, 2016 Hemispherx Biopharma (NYSE MKT: HEB) reported its financial results for the three months ended March 31, 2016 (Filing, Q1, Hemispherx Biopharma, 2016, MAY 16, 2016, View Source [SID:1234512453]). The net loss was approximately $2,164,000 or $(0.01) per share as compared to a net loss of $3,445,000 or ($0.02) per share for the same three month period in 2015. Cash, cash equivalents and marketable securities were approximately $7,849,000 at March 31, 2016 as compared to $8,910,000 as of December 31, 2015.

Hemispherx Biopharma recently made changes to its senior management team and implemented austerity measures which included the reduction of executive compensation and elimination of non-essential contractors and personnel. These measures have resulted in a significant reduction in costs and expenses. The company is now focusing on commercial success by seeking co-development partners and working closely with the research and regulatory communities to bring disease fighting technologies to the world.

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