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8-K – Current report

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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8-K – Current report

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.

8-K – Current report

On May 12, 2016 Cellectar Biosciences, Inc. (NASDAQ:CLRB), an oncology-focused biotechnology company, reported its financial results for the first quarter of 2016 (Filing, Q1, Cellectar Biosciences, 2016, MAY 16, 2016, View Source [SID:1234512452]).

During the first quarter of 2016, the company reported research and development expenses of $1.0 million, a reduction of $0.6 million from the first quarter of 2015. This improvement is attributable to the company’s shift in strategic focus on its therapeutic compound research and development efforts and the streamlined clinical trial approach it implemented during the second half of 2015.

Cellectar’s general and administrative expenses for first quarter 2016 totaled $1.0 million, similar to the prior year period. Loss from operations was $2.0 million, compared to $2.6 million during the same period last year.

The Company ended the first quarter with $1.9 million in cash and cash equivalents, compared to $3.9 million in cash and cash equivalents on December 31, 2015. When added to the approximately $7.2 million generated from the recently completed public offering, the company estimates that its available cash and cash equivalents should fund its planned operations into the first quarter of 2017. However, the company expects that additional capital will be required to complete its planned clinical and preclinical development.

"We continue to successfully execute our operating plan which included positive CLR 131 phase 1 data for the treatment of relapsed or refractory multiple myeloma, advanced our chemotherapeutic phospholipid drug conjugate program and launched our research collaboration with Pierre Fabre," said Jim Caruso. "We look forward to sharing these results in our conference call this afternoon and discussing our plans to further advance the company."

Cellectar will be holding a conference call at 5:00 PM ET today to review these results, as well as the company’s development plans. The call can be accessed by calling 888-646-8293. The call will also be webcast and replays will be available, both via the Investor Relations section of the company’s website: investor.cellectarbiosciences.com.

Asterias Biotherapeutics Reports First Quarter Results

On May 16, 2016 Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company with three clinical-stage development programs focused on the emerging field of regenerative medicine, reported financial results for the first quarter ended March 31, 2016 (Press release, BioTime, MAY 16, 2016, View Source;p=RssLanding&cat=news&id=2168708 [SID:1234512445]). The company also announced plans to expand the AST-OPC1 Phase 1/2a trial in spinal cord injury patients following recent clearance for the expansion by the U.S. Food and Drug Administration (FDA) based on the favorable safety profile observed so far with AST-OPC1 in the current study.

"Recent FDA clearance for expanding the AST-OPC1 clinical study in spinal cord injury patients and the recent capital raise needed to fund this expansion are key developments for Asterias," said Steve Cartt, President and Chief Executive Officer. "This important trial expansion should increase the statistical confidence of the safety and efficacy readouts, expand the range of spinal cord injury patients being evaluated, and better position the product for a potential accelerated regulatory pathway should we observe positive efficacy signals and continued safety in the study."

Mr. Cartt continued, "In addition, the capital we recently raised, despite the very challenging capital markets, significantly strengthened our cash position. Combined with continued non-dilutive funding from leading scientific institutions, this will allow Asterias to immediately progress our three clinical-stage programs toward important milestones targeted for late 2016 and into 2017."

As of May 15, 2016, the company’s cash, cash equivalents and available-for-sale securities totaled over $33 million. This includes a recent $2.5 million grant payment from the California Institute of Regenerative Medicine (CIRM) related to progress in the ongoing AST-OPC1 study.

Corporate Highlights

On May 13, 2016, Asterias raised approximately $16.2 million in net proceeds from a public offering of shares of its common stock and warrants. Asterias has granted the underwriters a 30-day option to purchase up to an additional 772,059 shares of common stock and/or additional warrants to purchase up to 386,029 shares of common stock to cover over-allotments, if any. The underwriters exercised their over-allotment option to purchase 386,029 additional warrants. If the over-allotment option to purchase the additional shares is exercised in full, additional net proceeds from the offering to Asterias will be approximately $2.4 million.
In April, Howard I. Scher M.D., one of the world’s leading oncology experts, was appointed to the Board of Directors of Asterias. Dr. Scher is internationally recognized for his expertise in clinical oncology. He has extensive experience in the design of clinical trials for novel anti-cancer agents, including monoclonal antibodies and other biologic therapies, cytotoxics, and drugs that target specific signaling pathways.
Research and Development Highlights

AST-OPC1 (oligodendrocyte progenitor cells)

Patient recruitment is ongoing for the second cohort in a Phase 1/2a clinical trial of AST-OPC1 in complete cervical spinal cord injury, in which five patients will be administered a dose of 10 million AST-OPC1 cells. This cohort is the first of two dose cohorts receiving doses in the predicted efficacious range based on preclinical studies. Asterias has been granted FDA clearance to expand patient enrollment in the Phase 1/2a clinical trial from 13 patients to up to 35 patients, based on the continued favorable safety profile observed in the ongoing clinical study. The company believes that the trial expansion should increase the statistical confidence of the safety and efficacy readouts, expand the range of spinal cord injury patients being evaluated, and better position the product for a potential accelerated regulatory pathway should the company observe positive efficacy signals and continued safety in the study. This trial is being funded in part by a $14.3 million grant from CIRM.
In February, the FDA granted Orphan Drug Designation for AST-OPC1 for the treatment of acute spinal cord injury. Orphan Drug Designation qualifies the sponsor of the drug certain benefits and incentives, including seven years of marketing exclusivity following regulatory approval, and financial incentives such as potential tax credits for certain activities and waiver of certain administrative fees.
In April, Asterias presented an overview of the AST-OPC1 therapeutic development program in spinal cord injury at the American Spinal Injury Association Annual Meeting and at the Stem Cell Summit 2016 meeting.
AST-VAC1 (antigen-presenting autologous dendritic cells)

In February, Asterias successfully completed the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for AST-VAC1, the company’s investigational cancer immunotherapy and lead clinical program targeting maintenance of relapse-free-survival in acute myeloid leukemia (AML) patients. The company currently is evaluating plans for progressing the AST-VAC1 program towards a pivotal Phase 3 trial which would begin in late 2017.
Clinical data from the Phase 2 trial of AST-VAC1 in AML was presented during an oral session at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 19th Annual Meeting on May 5, 2016. The data was first presented at the 2015 annual meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper).
AST-VAC2 (antigen-presenting allogeneic dendritic cells)

AST-VAC2 is Asterias’ innovative allogeneic (non-patient-specific) immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. The company’s research partner, Cancer Research UK (CRUK), will execute the first clinical trial of AST-VAC2. As part of this partnership, CRUK will perform cGMP manufacture of AST-VAC2 at its Biotherapeutics Development Unit, and will submit a Clinical Trial Authorisation application to the UK regulatory authorities for a Phase 1/2a clinical trial in non-small cell lung cancer. The trial will be sponsored, managed and funded by the CRUK Centre for Drug Development. Asterias anticipates receiving approval from UK regulatory authorities for clinical development of AST-VAC2 by the end of 2016 and beginning enrollment for the Phase 1/2a clinical trial in the first quarter of 2017. The trial will examine the safety, immunogenicity and activity of AST-VAC2 in non-small cell lung cancer patients and could potentially position the product for development in numerous cancer indications.
First Quarter Financial Update

Total revenues were $1.6 million for the first quarter. Revenues are comprised of grant income as well as royalty revenues on product sales by licensees. Research and development expenses were $6.3 million for the first quarter. General and administrative expenses were $6.3 million for the first quarter. Net loss was $10.3 million for the three months ended March 31, 2016, or $0.27 per share, including a deferred income tax benefit of $902,000. For the first quarter, net cash used in operating activities was $4.2 million.

Abeona Therapeutics Announces First Quarter 2016 Summary Financial Results and Recent Operational Highlights

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.

"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.