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 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 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the quarter ended March 31, 2016 and provided an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA-based immunotherapy (Press release, Celsion, MAY 16, 2016, View Source [SID:1234512425]).

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"We are extremely pleased with our product portfolio, our progress and the investment we have made in gene-based therapeutics," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "Over this past quarter alone, we have reported meaningful developments with both ThermoDox and our immunotherapeutic, GEN-1. Positive clinical, preclinical and translational data for GEN-1 in both first line and second line ovarian cancer has provided important insights on its potential clinical utility and safety, and reinforced our confidence in the potential of this important investigational product. We are looking forward to continued meaningful data from our Phase I neoadjuvant trial, the OVATION Study, throughout the year and its support for launching the Phase I/II clinical study later this year to evaluate the combination of GEN-1 with Avastin and Doxil in platinum-resistant ovarian cancer patients."

Mr. Tardugno continued, "We have made great strides to advance our global Phase III OPTIMA Study evaluating ThermoDox in primary liver cancer with clinical sites currently enrolling patients in 13 countries world-wide. With enrollment now open in China and approximately 50% of the 850,000 new cases of primary liver cancer diagnosed each year originating there, China represents a significant market opportunity and key element of our global development and commercialization strategy for ThermoDox. We expect to add up to 20 additional clinical sites and enroll more than 200 patients in the China territory, the minimum number required by the China FDA to file a New Drug Application (NDA), assuming positive clinical results."

Recent Developments

ThermoDox

Enrolled the first patient in the OPTIMA Study in China. On April 26, 2016, the Company announced that the first patient in China has been enrolled in its ongoing global Phase III OPTIMA Study. With China FDA’s approval of Celsion’s Phase III Study in first line primary liver cancer, the trial is now enrolling patients in 13 countries globally. With the addition of these Chinese clinical sites, the Company expects an increase in the rate of recruitment sufficient to complete enrollment in the OPTIMA Study by the end of 2017 or early 2018. Results from the OPTIMA Study, if successful, will provide the basis for a global registration filing and marketing approval.

GEN-1 Immunotherapy

Announced positive data from the first cohort of patients in the Phase 1b OVATION Study. In May 2016, the Company announced data from the first cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. In the first three patients dosed, GEN-1 plus standard chemotherapy produced positive clinical results, with no dose limiting toxicities and promising efficacy signals leading to successful surgical outcomes.

Of the three patients treated in the first cohort, two patients demonstrated stable disease (SD) and one patient demonstrated a complete response (CR), as measured by RECIST criteria.
All patients had successful resections of their tumors, with two patients having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed, and one patient with Stage IV ovarian cancer having an optimal R1 resection.
One patient demonstrated a pathological complete response (pCR). pCRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection, and have been associated with a median overall survival (OS) of 72 months, which is more than three years longer than those who do not experience a pCR.
All patients experienced a dramatic > 96% drop in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells. A 50% reduction in CA-125 levels is considered meaningful. All patients’ CA-125 levels were below the standard cutoff level of 35 U/mL.
Presented preclinical data for GEN-1 IL-12 Immunotherapy in combination with Avastin and Doxil at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016. In April 2016, the Company presented compelling preclinical data demonstrating significant synergistic anti-cancer effects when GEN-1 is combined with Avastin and Doxil, a current standard of care (SoC) for platinum resistant ovarian cancer patients at the 2016 AACR (Free AACR Whitepaper) Annual Meeting. The presentation showed that the three drug combination resulted in a statistically significant reduction of tumor burden of greater than 98% compared to control, and a statistically significant 92% reduction in tumor burden compared to Avastin plus Doxil alone. In contrast, Avastin and GEN-1 produced a 39% and 50% reduction in tumor burden, respectively. These preclinical data are consistent with the mechanism of action for GEN-1, which exhibits certain anti-angiogenic properties in addition to its well-characterized immunomodulatory activities. The combination of GEN-1 with Avastin and Doxil was well-tolerated with no systemic toxicities. These preclinical data will be used by the Company to support a comprehensive IND protocol filing for a Phase I/II clinical trial evaluating the combination in recurrent ovarian cancer later this year.

Reported translational data from its Phase Ib Study of GEN-1 Immunotherapy in recurrent ovarian cancer. In January 2016, the Company announced new translational data from its Phase Ib study of GEN-1 in patients with platinum-resistant ovarian cancer. The new data indicated that intraperitoneally-administered GEN-1 produces an immunologically distinct IL-12 protein that is localized at the tumor site and lasts for up to one week after a single treatment. In addition, concomitant increases in IFN-γ and TNF-α indicate that the IL-12 produced following treatment with GEN-1 treatment is immunologically active. Celsion intends to collect additional translational data, including cellular responses in primary tumor tissue and peritoneal ascites, in its ongoing OVATION Study, a Phase I dose escalation study in newly diagnosed ovarian cancer patients in the neoadjuvant setting.

Financial Results

For the quarter ended March 31, 2016, Celsion reported a net loss of $5.7 million, or $0.24 per share, compared to a net loss of $7.0 million, or $0.35 per share, in the same period of 2015. Operating expenses were $5.3 million for the quarter ended March 31, 2016 compared to $6.5 million in in the same period of 2015. This decrease was primarily due to lower research and development and general and administrative expenses in the first quarter of 2016 compared to the first quarter of 2015.

Research and development costs were $3.4 million in the first quarter of 2016 compared to $4.5 million in the same period of the prior year. In the first quarter of 2015, the Company produced clinical supplies to support both its ThermoDox and GEN-1 clinical programs. General and administrative expenses were $1.9 million in the first quarter of 2016 compared to $2.0 million in the same period of the prior year.

Net cash used in operations was $4.7 million the first quarter of 2016 compared to $5.9 million in the same period of the prior year. The Company ended the first quarter of 2016 with $14.3 million of total cash and cash equivalents.

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 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage immuno-oncology drug development company, reported that its lead cancer therapeutic HuMab-5B1 (MVT-5873) was featured in a poster presentation on May 13th at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer: Advances in Science and Clinical Care, held in Orlando, Florida (Press release, MabVax, MAY 16, 2016, View Source [SID:1234512427]). MVT-5873 is currently being evaluated in an open-label, multicenter, dose-escalation Phase I clinical trial as a single agent and in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer.

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"The poster presentation provides compelling data as to the potential benefits of combining MVT-5873 with the standard of care chemotherapeutic regimen gemcitabine/nab-paclitaxel (Abraxane) for patients with advanced pancreatic cancer," said David Hansen, CEO of MabVax. "In this study, MVT-5873 administered as a single agent demonstrated antitumor activity in a xenograft mouse model of human pancreatic cancer. Moreover, when combined with gemcitabine/nab-paclitaxel, MVT-5873 potentiated the anti-tumor activity of the chemotherapy. Importantly, MVT-5873 activity in these models was demonstrated at doses clinically relevant to our ongoing Phase I trial in patients with metastatic pancreatic cancer."

The poster "Antitumor activity of MVT-5873, a monoclonal antibody targeting sialyl Lewisa, alone and in combination with gemcitabine/nab-paclitaxel in a BxPC3 human pancreatic cancer xenograft model," (Ragupahti, et al.) was presented by Paul Maffuid, Ph.D., Executive Vice President of Research and Development of MabVax. The study data showed that in a BxPC3 human pancreatic cancer model, MVT-5873 potentiates the activity of a standard of care regimen for patients. The results of the investigation include a comparison of pharmacokinetics and pharmacodynamics and provide evidence for tumor absorption. These data are substantiated by IHC studies that indicate specific binding of MVT-5873 to BxPC3 tumor tissues, with uptake intensified relative to dose administration.

"It is exciting to further accumulate data validating our fully human antibody approach to cancer therapeutics and to present these data at the AACR (Free AACR Whitepaper) Special Meeting on Pancreatic Cancer," added Mr. Hansen. "We expect to begin a second Phase I trial later this month, with this trial evaluating MVT-2163, also based on our HuMab-5B1 antibody, as a next-generation PET imaging agent for the diagnosis and management of patients with pancreatic cancer. We anticipate reporting preliminary data from both Phase I trials during the third quarter of this year. In addition we are planning to enroll patients in the second half of this year."