CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study

On August 15, 2018 CEL-SCI Corporation (NYSE American: CVM) reported that the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data (Press release, Cel-Sci, AUG 15, 2018, View Source [SID1234528894]). The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study.

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The IDMC made the following recommendation:

The IDMC recommendation is to continue the trial until the appropriate number of events have occurred.
IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials, especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time.

Genprex Provides Clinical and Corporate Update for Second Quarter 2018

On August 15, 2018 Genprex, Inc. (NASDAQ:GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported a clinical and corporate update, and the filing of quarterly results for the second quarter ended June 30, 2018 on Form 10-Q with the Securities and Exchange Commission (Press release, Genprex, AUG 15, 2018, View Source [SID1234528893]).

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Rodney Varner, Chairman and CEO, remarked, "We have made significant progress in recent months to advance the development of Oncoprex for treatment of non-small cell lung cancer (NSCLC), including engaging collaborators with expertise and other resources necessary for important pre-clinical and clinical services. We also obtained an additional $10 million in capital, which provides additional financial resources to position the Company to achieve its critical milestones in its path toward developing and commercializing Oncoprex. "

Julien L. Pham, MD, MPH, President and Chief Operating Officer, stated, "We are moving toward resuming enrollment in the Phase I/II clinical evaluating the combination of Oncoprex and erlotinib (Tarceva) for the treatment of Stage IV non-small cell lung cancer (NSCLC), adding an additional preclinical trial to study Oncoprex in combination with immunotherapies, and progressing with manufacturing scale-up."

Clinical Development Highlights (May 2018 to present)

Selected Accenture to provide clinical data management services to help accelerate the clinical development of Genprex’s lead drug candidate, Oncoprex.
Entered an agreement to use WIRB-Copernicus Group (WCG) to provide site selection and feasibility services, including Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) oversight for new clinical trial sites that Genprex anticipates adding to participate in its Phase I/II clinical trial evaluating the combination of OncoprexTM and erlotinib (Tarceva) in NSCLC.
Selected 4Clinics as a CRO to provide clinical and regulatory support for the clinical development program in the form of biostatistics, statistical programming and analysis, as well as medical and scientific writing for the Phase I/II clinical trial.

Entered an agreement with The University of Texas MD Anderson Center under which Genprex is sponsoring a pre-clinical study intended to develop a novel therapeutic approach for the treatment of cancer using a combination of the multifactorial tumor suppressor gene TUSC2 and immunotherapy, including the immune checkpoint inhibitors anti-PD1 and/or anti CTLA-4. This study will include the identification of biomarkers to predict the response to TUSC2-immunotherapy combinations.
Amended its agreement with The University of Texas MD Anderson Cancer Center to resume patient enrollment in its Phase I/II trial evaluating the combination of Oncoprex and erlotinib (Tarceva) for the treatment of Stage IV non-small cell lung cancer (NSCLC).
Corporate Update

Entered an agreement with the University of Texas at Austin Dell Medical School to establish executive offices at the school’s Health Discovery Building, joining the WorkSpaces @ Texas Health CoLab. WorkSpaces @ Texas Health CoLab is designed to identify and support people and companies that share Dell Medical School’s commitment to improving health outcomes to patients and reducing healthcare costs.
Established offices in Cambridge, MA, where Dr. Julien Pham, President and COO will oversee the clinical development of Genprex’s lead drug candidate, Oncoprex.
Completed a $10 million private placement.
Forward Looking Statements

Statements contained in this press release that are not statements of historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because these statements are subject to risks and uncertainties, the actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements about Genprex’s business plans, statements about the timing and success of the Company’s existing and planned clinical trials, statements about the development of the Company’s current and potential future product candidates, statements about the Company’s plans to seek regulatory approval of its product candidates, and statements about the services the Company expects to receive from its development partners and the effect of those services on the development of Oncoprex. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost and timing of the Company’s product candidate development activities and current and planned clinical trials; the Company’s ability to execute on its strategy; regulatory developments in the United States and foreign countries; the Company’s estimates regarding expenses, future revenue and capital requirements; and the ability of the Company’s development partners to provide services to the Company and the Company’s ability to utilize those services, and the ability of those services to influence the development of Oncoprex. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Genprex’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Genprex does not undertake any obligation to update these statements to reflect any events that occur or facts that exist after the date on which the statements were made.

SELLAS Life Sciences Provides Business Update and Reports Second Quarter 2018 Financial Results

On August 15, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the quarter ended June 30, 2018 (Press release, Sellas Life Sciences, AUG 15, 2018, View Source [SID1234528887]).

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"During the second quarter of 2018 we made significant progress in laying the foundation for executing on our clinical programs by closing the second tranche of our sale of Series A Preferred Stock and warrants and commencing the process for a follow-on equity offering. We are pleased to have closed that equity financing last month which, together with the proceeds from the sale of the preferred stock and warrants, provides us with funding to begin to advance our pipeline of novel cancer immunotherapies, focusing first on galinpepimut-S (GPS)," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We plan to initiate our Phase 1/2 basket trial of GPS in combination with Keytruda in a number of indications by the end of the third quarter with the first patient in during the fourth quarter and are actively finalizing our clinical plan for a Phase 3 study of GPS in patients with acute myeloid leukemia. Looking ahead, we are also excited to present our Phase 2b data of Herceptin +/- NeuVax in an oral presentation at the 2018 Annual Meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in late October as well as optimizing our regulatory strategy for NeuVax with U.S. and European regulatory authorities and exploring strategic partnering alternatives around NeuVax," continued Dr. Stergiou.

Second Quarter 2018 and Recent Business Highlights

In July 2018, SELLAS completed an underwritten public offering of common stock and pre-funded warrants, together with accompanying common stock warrants, for aggregate net proceeds of approximately $21.6 million, after deducting underwriting discounts, commissions and offering expenses.
In July 2018, SELLAS announced that data on the adjuvant treatment of women with triple-negative breast cancer (TNBC) with the combination of trastuzumab (Herceptin) +/- NeuVax from a Phase 2b independent investigator-sponsored trial (IST) will be presented at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting October 19-23 in Munich, Germany.
In July 2018, SELLAS announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to GPS for the treatment of multiple myeloma (MM).
In June 2018, SELLAS presented interim data from an open-label Phase 1 IST of GPS in combination with nivolumab in patients with Wilms Tumor 1 (WT1)+ ovarian cancer in second or third remission after salvage chemotherapy at the 2018 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Exploratory efficacy interim data showed that GPS, when combined with a PD-1 inhibitor, demonstrated a progression-free survival rate of 64% at one year in an intent to treat group of 11 evaluable patients with WT1+ ovarian cancer in second or greater remission. Among patients who received at least three doses of GPS in combination with nivolumab, PFS at one year was 70% (7/10). The historical rates with best standard treatment do not exceed 50% in this disease setting.
In June 2018, SELLAS announced that the Phase 2b independent IST of Herceptin +/- NeuVax in HER2 1+/2+ breast cancer patients achieved its key clinical development objectives and was being discontinued, based in part on the recommendation of the independent Data Safety Monitoring Board to further develop the NeuVax + Herceptin combination for patients with TNBC.
In June 2018, the Company was issued U.S. Patent No. 9,993,538 which is a method of use patent that is part of the patent portfolio for the GALE-301 and GALE-302 folate binding protein derived peptides. The method claims cover a dosing regimen to induce an immune response against a tumor expressing folate receptor alpha (FR-alpha) using the GALE-301 peptide (peptide of FR-alpha epitope E39) and the GALE-302 peptide booster (peptide of FR-alpha epitope E39’). The patent will expire on May 31, 2036 and provides further patent protection on the initial GALE-302 patent family, which expires in 2022.
In May 2018, SELLAS announced that the FDA granted orphan drug designation to GPS for the treatment of MM.
In May 2018, SELLAS completed the second tranche of its $10.7 million private placement transaction.
In April 2018, SELLAS appointed Gene Mack as Chief Financial Officer and Treasurer.
Second Quarter 2018 Financial Results

For accounting purposes, SELLAS Life Sciences Group Ltd., a private Bermuda exempted company (SELLAS Ltd.), is considered to have acquired the Company (which was formerly known as Galena Biopharma, Inc. (Galena)) in the business combination between SELLAS Ltd. and Galena (the Merger); therefore, upon the Merger, the financial statements of Galena became those of SELLAS Ltd. and the results reported are those of SELLAS Ltd. reflecting the acquisition of Galena as of December 29, 2017.

Cash Position: As of June 30, 2018, cash and cash equivalents were $1.3 million, compared to $2.3 million as of December 31, 2017. Net cash used in operating activities was $11.7 million for the first half of 2018, partially offset by $8.9 million of net cash provided by financing activities. On July 16, 2018, SELLAS completed an underwritten public offering of common stock and pre-funded warrants, together with accompanying common stock warrants, for aggregate net proceeds of approximately $21.6 million, after deducting underwriting discounts, commissions and offering expenses.

R&D Expenses: Research and development expenses were $1.6 million for the second quarter of 2018, as compared to $1.8 million for the second quarter of 2017. The decrease was primarily attributable to a decrease in licensing fees, partially offset by a severance charge and an increase in clinical and regulatory consulting services. Research and development expenses for the six months ended June 30, 2018 were $3.4 million, as compared to $4.0 million for the same period in 2017. The decrease was primarily attributable to a decrease in licensing fees.

G&A Expenses: General and administrative expenses were $4.9 million for the second quarter of 2018, as compared to $3.8 million for the second quarter of 2017. The increase was primarily driven by an increase in legal fees related to ongoing litigation and other legal matters related to Galena’s business and operations, personnel related expenses and an increase in insurance premiums. These increases were partially offset by a decrease in stock-based compensation expense. General and administrative expenses for the first half of 2018 were $8.8 million, as compared to $6.1 for the six months ended June 30, 2017. The increase during the period was primarily related to legal and advisory fees associated with the Merger with Galena and ongoing litigation and other legal matters related to Galena’s business and operations.

Net Loss: Net loss attributable to common stockholders was $8.5 million for the second quarter of 2018, or a basic and diluted loss per share attributable to common stockholders of $1.26, as compared to a net loss attributable to common stockholders of $5.9 million for the second quarter of 2017, or a basic and diluted loss per share attributable to common stockholders of $4.50. Net loss attributable to common stockholders was $18.5 million for the six months ended June 30, 2018, or a basic and diluted loss per share attributable to common stockholders of $2.89, as compared to a net loss attributable to common stockholders of $10.5 million for the prior period, or a basic and diluted loss per share attributable to common stockholders of $8.14.

RXI PHARMACEUTICALS AND KAROLINSKA INSTITUTET ENTER INTO COLLABORATION TO DEVELOP SD-RXRNA COMPOUNDS TO IMPROVE FUNCTIONALITY AND PERSISTENCE OF T CELLS AND NK CELLS FOR THE ADVANCEMENT OF IMMUNO-ONCOLOGY THERAPEUTICS FOR SOLID TUMORS

On August 15, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform reported that it has entered into a research collaboration with the Karolinska Institutet in Stockholm, Sweden (Press release, RXi Pharmaceuticals, AUG 15, 2018, View Source [SID1234528886]). This collaboration will explore RXi’s sd-rxRNA compounds against targets involved in T cell and NK cell differentiation and/or in the immune cell tumor-induced stress response with the aim of producing anti-tumor adoptive cell therapy grafts with improved functionality and persistence.

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This work will expand on the recently published results from the Kiessling group demonstrating that an sd-rxRNA targeting PD-1 can enhance TIL antitumor activity against melanoma cells in vitro, further showing that ex vivo treatment with the sd-rxRNA compounds was easily incorporated into a clinically relevant rapid expansion protocol for TILs.1

Dr. Gerrit Dispersyn, Chief Development Officer of RXi Pharmaceuticals, stated: "We are pleased to expand our collaboration with Dr. Kiessling’s group, to further harness their expertise in oncology and to expand on the successful research they have previously done with our sd-rxRNA technology platform in immuno-oncology. The combination of their prior results and the anticipated research results from this new collaboration are critical elements for a rapid advancement of sd-rxRNA immuno-oncology therapeutics into the clinic, further supported by our prior clinical experience with sd-rxRNA in other indications."

Rolf Kiessling, MD, PhD, Senior Professor in Experimental Oncology at the Karolinska Institutet, Senior Chief Physician at the Oncology clinic at the Karolinska University Hospital and member of RXi’s Scientific Advisory Board stated: "Our results to date provide direct clinical relevance for the use of sd-rxRNA technology to improve ACT. In this collaboration, we look forward to exploring using sd-rxRNA to modulate targets outside of checkpoints to improve efficacy of immune effector cells such as T cells and NK cells."

Immunotherapy of cancer has become increasingly important in clinical practice over the recent decade. By activating the patient’s immune system, immunotherapy treatments have shown remarkable promise in extending the lifespan of previously untreatable cancer patients. Adoptive cell therapy is an emerging immunotherapy approach which uses immune cells, such as T-lymphocytes or NK cells that are isolated from the patient or retrieved from allogeneic immune cell banks, and then expanded and in some cases processed to express tumor-binding receptors.

A new and important step in this ex-vivo processing of the immune cells is in development where self-delivering RNAi compounds (sd-rxRNA) are used to eliminate the expression of immunosuppressive receptors or proteins from the therapeutic immune cells, thereby making them less sensitive to tumor resistance mechanisms and improving their ability to destroy tumor cells. In this way, sd-rxRNA therapeutic compounds can be used to weaponize therapeutic immune cells to attack cancer and ultimately provide patients battling terminal cancers with a powerful new treatment option that goes beyond current treatment modalities.

About RXi Pharmaceuticals

RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (sd-rxRNA) therapeutic platform. The Company’s discovery and research efforts are focused on developing sd-rxRNA therapeutic compounds to be used with an Adoptive Cell Transfer (ACT) approach. This process uses immune cells, such as T-lymphocytes that are isolated from the patient or retrieved from allogeneic immune cell banks, and then expanded and in some cases processed to express tumor-binding receptors. Our approach introduces a new and important step in ex-vivo processing of the immune cells where sd-rxRNA is used to eliminate the expression of immunosuppressive receptors or proteins from the therapeutic immune cells, making them less sensitive to tumor resistance mechanisms and thus improving their ability to destroy the tumor cells. Essentially, we aim to maximize the power of our sd-rxRNA therapeutic compounds by weaponizing therapeutic immune effector cells to attack cancer and ultimately provide patients battling terminal cancers with a powerful new treatment option that goes beyond current treatment modalities.

Neuralstem Provides Business Update and Reports Second Quarter 2018 Fiscal Results

On August 15, 2018 Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell and small molecule compound technologies, reported its financial results for the second quarter ended June 30, 2018 (Press release, Neuralstem, AUG 15, 2018, View Source [SID1234528876]).

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"We are pleased to report a productive second quarter of 2018 as we continue to advance our pipeline of innovative neural stem cell and small molecule therapies," said Jim Scully, interim Chief Executive Officer of Neuralstem. "We are especially excited about the advancement of our lead stem cell therapy candidate, NSI-566, into a Phase 2 trial in ischemic stroke, as well as its potential application to other areas of unmet medical need. Additionally, based on encouraging preclinical data, we look forward to exploring our small molecule NSI-189’s potential treatment applications, including Angelman Syndrome and Alzheimer’s Disease."

Clinical Highlights

NSI-566, is a spinal cord-derived neural stem cell line that is being evaluated to treat paralysis associated with stroke, Amyotrophic Lateral Sclerosis (ALS) and chronic spinal cord injury (cSCI). NSI-566 is Neuralstem’s lead stem cell therapy candidate.

In July, Neuralstem announced initiation of a Phase 2 clinical trial evaluating NSI-566 as a potential treatment for ischemic stroke. This trial, which will be a randomized, double-blind, controlled study, is based on the positive results from the open-label Phase 1 safety study and is intended to further test the safety and efficacy of NSI-566 to reverse paralysis in stroke patients where half of their body has been partially paralyzed. James Li, Ph.D., Executive Vice President of Asia Operations of Suzhou Neuralstem Ltd, will be managing this trial which will be taking place at Bayi Brain Hospital in Beijing, China, and commenced on August 1, 2018. In Phase 1, NSI-566 treatment of 9 chronically hemiparetic stroke patients resulted in statistically significant improvement from baseline of motor functioning and clinical status.

In June, the Company announced the results from a study published in Cell Stem Cell that support the potential therapeutic application of transplanted NSI-566 in patients with chronic spinal cord injury (cSCI). The manuscript, entitled "A First-in-Human, Phase I Study of Neural Stem Cell Transplantation for Chronic Spinal Cord Injury," presented a detailed analysis of motor and sensory function and electrophysiology results which showed improvement in three of the four patients after NSI-566 transplantation. The study’s primary objective was to evaluate the safety of NSI-566 transplantation in subjects with stable thoracic spinal cord injury, and additional endpoints measured included changes in neurologic deficits, neurophysiology, and neuropathic pain.

In May, the Company announced the results from a study published in the Annals of Clinical and Translational Neurology in a manuscript entitled "Long-term Phase 1/2 Intraspinal Stem Cell Transplantation Outcomes in Amyotrophic Lateral Sclerosis" that support the potential of transplanted human spinal cord-derived neural stem cells (HSSC) to stabilize functioning of ALS patients. The study evaluated the impact of HSSC transplantation on functional outcomes, as measured using the ALSFRS-R scale, and on a composite statistic that combined functional and survival outcomes. Results were evaluated against matched controls derived from two historical datasets and showed significantly better ALSFRS-R scores at 24 months, as well as the composite functional/survival score in subjects receiving HSSC. The ALS Functional Rating Scale-Revised (ALSFRS-R) is a validated questionnaire that measures physical function in performing activities of daily living (ADLs).
NSI-189, is a small molecule benzylpiperazine-aminopyridine, in clinical development for MDD and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, Type 1 and Type 2 diabetes, and stroke.

In August, the Company announced it had been granted orphan drug designation by the FDA for the treatment of Angelman Syndrome. In pre-clinical models, NSI-189 has demonstrated the ability to restore long term potentiation (LTP), a measure of synaptic plasticity and an in vitro biomarker of memory. Angelman Syndrome (AS) is a rare congenital genetic disorder caused by a lack of function in the UBE3A gene on the maternal 15th chromosome. It affects approximately one in 15,000 people – about 500,000 individuals globally. Symptoms of AS include developmental delay, lack of speech, seizures, and walking and balance disorders. Patients with AS may never walk or speak and require life-long care. Life expectancy is normal which places a significant burden on patients and caregivers. There are currently no FDA-approved therapies for the treatment of Angelman syndrome. The FDA’s orphan-drug designation program provides special status and incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. Orphan drug designation confers seven years of market exclusivity upon FDA approval, as well as other development incentives, such as tax credits related to clinical trial expenses, an exemption from the FDA-user fee and FDA assistance in clinical trial design.

In July, the Company presented preclinical data at the Alzheimer’s Association International Conference in Chicago, Illinois, demonstrating that oral administration of NSI-189 in a mouse model of Alzheimer’s Disease leads to a significant amelioration and/or improvement in cognition measures and anxiety. Results were presented in a poster titled ‘Effect of Neurogenic Compound NSI-189 on Indices of Cognition and Anxiety in a Mouse Model (5XFAD) of Alzheimer’s Disease.’ The study was carried out by Dr. Corinne Jolivalt’s laboratory at the University of California, San Diego, and found that treatment with NSI-189 significantly improved learning ability as well as retention, short-term memory and anxiety levels of mice.
Corporate Highlights

Effective August 1, Jim Scully was appointed as interim chief executive officer by the Board of Directors. Mr. Scully succeeds Mr. Rich Daly, former Neuralstem president and chief executive officer. Mr. Scully brings to Neuralstem a wealth of experience from a range of senior executive roles in the pharmaceutical and broader healthcare industry, including leadership roles in financial and strategic planning, global business development and general management at Takeda Pharmaceuticals, Astellas Pharmaceuticals, Abbott Laboratories and Walgreens.

Also, effective August 1, the Board of Directors appointed William Oldaker as Chairman of the Board. Mr. Oldaker has served as a director of Neuralstem since April 2007. Additionally, he is a founder and partner in the Washington, D.C. law firm, Oldaker & Willison PLLP, and is a member of the Colorado, D.C. and Iowa Bar Associations, the Bar Association for the Court of Appeals, D.C., and the Bar of the United States Supreme Court.
Financial Results for the Quarter Ended June 30, 2018

Cash Position and Liquidity: At June 30, 2018, cash and investments was $7.1 million as compared to $9.7 million at March 31, 2018. The $2.6 million decrease reflects a $0.6 million loss for the period adjusted for certain non-cash items including a $1.4 million gain related to the change in fair value of our liability classified warrants, $760,000 net cash outflows related to changes in operating assets and liabilities, and $200,000 of share-based compensation. The Company expects its existing cash, cash equivalents and short-term investments to fund its operations based on its current operating plans, into the first quarter of 2019.

Operating Loss: Operating loss for the second quarter ended June 30, 2018 was $2.0 million compared to a loss of $4.2 million for the comparable period of 2017. Operating loss for the six months ended June 30, 2018 was $4.4 million compared to a loss of $8.5 million for comparable period of 2017.

The decrease in operating loss for both the three- and six-month periods was primarily related to decreases in clinical trial and related costs due to the completion of the NSI-189 Phase 2 clinical trial, decreases in personnel, facility and related expenses due to ongoing corporate restructuring and cost reduction efforts offset by revenues from a milestone-based royalty and reimbursements under a National Institute of Health (NIH) grant.

Net Loss: Net loss for the second quarter ended June 30, 2018 was $0.6 million, or $0.04 per share (basic), compared to a loss of $4.6 million, or $0.39 per share (basic), for the comparable period of 2017. The decrease in net loss was primarily due to a decrease in operating loss and the non-cash charges related to the change in the fair value of liability classified warrants.

Net loss for the six months ended June 30, 2018 was $2.8 million, or $0.18 per share (basic), compared to a loss of $12.2 million, or $1.06 per share (basic), for the comparable period of 2017. The decrease in net loss was primarily due to a decrease in operating loss and the non-cash charges related to the change in the fair value of liability classified warrants and warrant inducement expenses in the 2017 period and a decrease in interest expense related to our long-term debt which matured in April 2017.

Research and Development Expenses: The $1.0 million of research and development expenses for the quarter ended June 30, 2018 represents a $1.6 million, or 61% decrease over the comparable period of 2017. This decrease was primarily attributable to a $710,000 decrease in personnel and facility expenses due to ongoing corporate restructuring and cost reduction efforts, a $310,000 decrease in clinical trial and related costs due to the completion of our NSI-189 Phase 2 clinical trial and a $410,000 decrease in non-cash share-based compensation expense along with $90,000 of reimbursements under a NIH grant.

The $2.2 million of research and development expenses for the six months ended June 30, 2018 represents a $3.3 million, or 60% decrease over the comparable period of 2017. This decrease was primarily attributable to a $1.8 million decrease in personnel and facility expenses due to ongoing corporate restructuring and cost reduction efforts, a $540,000 decrease in clinical trial and related costs due to the completion of the NSI-189 Phase 2 clinical trial, a $720, 000 decrease in our non-cash share-based compensation expense along with $180,000 of reimbursements under a NIH grant.

General and Administrative Expenses: The $1.3 million of general and administrative expenses for the second quarter ended June 30, 2018 represents a $380,000, or 23% decrease over the comparable period of 2017. This decrease was primarily attributable to a $400,000 decrease in payroll and related expenses due to corporate restructuring and cost reduction efforts coupled with a $40,000 decrease in non-cash share-based compensation expense partially offset by a $70,000 increase in tax and insurance expenses.

The $2.4 million of general and administrative expenses for the six months ended June 30, 2018 represents a $530,000, or 18% decrease over the comparable period of 2017. This decrease was primarily attributable to a $560,000 decrease in payroll and related expenses coupled with a $40,000 decrease in consulting and professional service expenses due to corporate restructuring and cost reduction efforts partially offset by a $90,000 increase in our tax and insurance expenses.