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Celsion Corporation Reports Second Quarter 2016 Financial Results and Provides Business Update

On August 15, 2016 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported financial results for the quarter and six month period ended June 30, 2016 and provided an update on its development programs for ThermoDox, the Company’s proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA-based immunotherapy (Press release, Celsion, AUG 15, 2016, View Source [SID:1234514583]).

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"We are extremely pleased with the momentum that we have built throughout the first half of this year; and especially proud of the meaningful developments in our two lead programs," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "The data from our immunotherapy program, particularly the initial data from our OVATION study in first line ovarian cancer, continue to provide important insights into GEN-1’s favorable clinical and safety profile and reinforce our confidence in its potential to serve as an effective therapy in a broad range of cancers."

Mr. Tardugno continued, "We have also 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 worldwide. In addition, data presentations and publications in multiple peer-reviewed forums continue to highlight the potential for a curative approach of ThermoDox plus optimized RFA. We are pleased to report that the most recent analysis of the HEAT Study data is consistent with a two year survival benefit in the ThermoDox plus optimized RFA group versus optimized RFA alone."

Recent Developments

Immunotherapy – GEN-1

Announced Positive Data from the First Two Cohorts of the OVATION Study. In July 2016, the Company announced data from the second cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1 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 six patients dosed, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. The efficacy data included encouraging tumor response rates, successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic drops in CA-125 protein levels. Enrollment in the third cohort is completed. Celsion expects the 4th, and final, Phase 1 cohort of the OVATION Study to be fully enrolled this year.

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. 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. 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.

Established Manufacturing and Commercial Supply Agreement with Hisun for GEN-1. In August 2016, Celsion signed a long term technology transfer, manufacturing and commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. The agreement relates to both the clinical and commercial manufacture and supply of GEN-1 for the greater China territory, with the option to expand into other countries in the rest of the world after all necessary regulatory approvals are in effect. With highly cost effective pricing, the agreement will help to support supply for ongoing and planned clinical studies in the United States and potential future studies of GEN-1 in China.

Chemotherapy – ThermoDox

Announced Final Overall Survival Data from HEAT Study of ThermoDox in Primary Liver Cancer. On August 15, 2016, the Company announced updated results from its final retrospective analysis of 701-patient HEAT Study. The overall survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n= 285, 41% of the HEAT Study patients), treatment with a combination of ThermoDox and optimized RFA provided an average 54% risk improvement in OS compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis is 0.65 (95% CI 0.45 – 0.94) with a p-value of 0.02. Median overall survival for the ThermoDox group has been reached which translates into a two year survival benefit over the optimized RFA only group (projected to be greater than 80 months for the ThermoDox plus optimized RFA group compared to less than 60 months projection for the optimized RFA only group). In the population of 154 patients with single lesions (70% of the HEAT Study Chinese patient cohort) who received optimized RFA treatment for 45 minutes or more showed a 53% risk improvement in OS (HR = 0.66) when treated with ThermoDox plus optimized RFA. These data continue to support and further strengthen ThermoDox’s potential to significantly improve OS compared to an RFA control in patients with lesions that undergo optimized RFA treatment for 45 minutes or more.

Announced a Peer Reviewed Publication in Hepatic Oncology Highlighting the Potentially Curative Potential of ThermoDox in Primary Liver Cancer. On June 21, 2016, the Company announced publication of the article, "RFA plus lyso-thermosensitive liposomal doxorubicin: In search of the optimal approach to cure intermediate-size hepatocellular carcinoma," in the June 10, 2016 issue of Hepatic Oncology. The article provided a comprehensive overview of the clinical evaluation conducted to date of ThermoDox for the treatment of primary liver cancer and detailed learnings from the Company’s 701 patient HEAT Study, a computational modeling study, an experimental animal study and the HEAT Study post hoc subgroup analysis. All of these studies are consistent with each other and collectively demonstrate ThermoDox‘s heat-based mechanism of action, that the longer the target tissue is heated, the greater the doxorubicin tissue concentration. Additionally, the article explores the potential for ThermoDox, when used in combination with Radio Frequency Ablation (RFA) standardized to a minimum dwell time of 45 minutes, to increase the overall survival of patients with primary liver cancer.

Announced Presentation Highlighting Phase III OPTIMA Study at the Asia-Pacific Primary Liver Cancer Expert Meeting. On July 11, 2016, the Company announced that its ongoing Phase III OPTIMA trial evaluating ThermoDox in primary liver cancer was featured during an oral presentation at the 7th Asia-Pacific Primary Liver Cancer Expert (APPLE) Meeting. The presentation highlighted the potential of ThermoDox plus standardized RFA to significantly improve overall survival of newly diagnosed patients.

Corporate Developments

Raised $6 Million Through A Registered Direct Offering. In June 2016, the Company completed a $6 million registered direct equity offering of shares of common stock, or pre-funded warrants in lieu thereof, and a concurrent private placement of warrants to purchase common stock with an institutional healthcare investor. If exercised, the short dated (six months) private placement warrants will provide an additional $6 million of operating cash.

Financial Results

For the quarter ended June 30, 2016, Celsion reported a net loss of $4.5 million, or $(0.19) per share, compared to a net loss of $5.7 million, or $(0.27) per share, in the same period of 2015. Operating expenses were $4.9 million in the second quarter of 2016 compared to $5.4 million in the same period of 2015. For the six month period ended June 30, 2016, the Company reported a net loss of $10.2 million, or $(0.43) per share, compared to $12.7 million, or $(0.62) per share, in the same six month period of 2015. Operating expenses were $10.2 million in the first half of 2016 compared to $11.9 million in the same period of 2015. Net cash used in operations was $9.0 million in the first half of 2016 compared to $11.6 million in the same period last year. The Company ended the second quarter of 2016 with $14.5 million of total cash, investments and accrued interest on these investments, which included the proceeds of a $6 million registered direct offering completed during the second quarter.

Research and development costs were $3.3 million in the second quarter of 2016 compared to $3.6 million in the same period last year. Research and development costs were $6.8 million in the first half of 2016 compared to $8.1 million in the same period last year. The decreases in 2016 are primarily the result of lower clinical supply costs for the ThermoDox and GEN-1 studies partially offset by increased costs associated with the enrollment in the OPTIMA and the OVATION studies. General and administrative expenses were $1.5 million in the second quarter of 2016 compared to $1.8 million in the same period of 2015. General and administrative expenses were $3.4 million in the first half of 2016 compared to $3.8 million in the same period of 2015. These decreases were primarily the result of lower personnel related costs and professional fees.

Moleculin Biotech, Inc. Reports Financial Results for the Second Quarter Ended June 30, 2016

On August 15, 2016 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center ("MD Anderson"), reported its financial and operating results for the second quarter ended June 30, 2016 (Press release, Moleculin, AUG 15, 2016, View Source [SID:1234514576]).

During the second quarter and year to date, key activities included:
Successful initial public offering and closing of transactions conditioned upon its IPO, including the acquisition of worldwide rights relating to its WP1066 drug portfolio;
Validation of Annamycin in an engineering run with a new combination of suppliers, paving the way for supply of Annamycin for our planned Phase IIb clinical trial;
Presentation of patented prodrug of a glucose decoy, WP1122, discovered at MD Anderson and licensed to Moleculin, with potential to target a wide variety of solid tumors highly dependent on glucose to survive, at the 28th Annual International Carbohydrate Symposium; and
Expansion of its research sponsorship at MD Anderson Cancer Center, facilitating access to grant funding and cutting edge research capabilities.
Planned activities and milestones for the remainder of 2016 include:
Apply for Orphan Drug status and validate the potential for accelerated approval pathway for Annamycin which could include the potential for approval on the basis of a pivotal Phase IIb clinical trial;
Prepare for Phase IIb clinical trial for liposomal Annamycin, an anthracycline for the treatment of relapsed or refractory acute myeloid leukemia;
Strengthen license and IP portfolio; and
Continue development of pipeline assets, including Annamycin and other molecular portfolios.
Walter Klemp, Chairman and CEO of Moleculin, stated: "We are excited with our prospects and programs ahead in both the short and longer terms and are proud of our achievements to date. With our recent successful capital raise complete and sufficient funds to pursue our planned operations for the next twelve months from the offering date, our near term goal and potential catalyst includes the commencement of our Phase II registration trial for Annamycin. We believe Annamycin represents a potentially game-changing advancement in the treatment of acute leukemia and we are focused on advancing and bringing to market this and other potentially life saving therapies in the most expeditious, safe and efficient manner while also capitalizing on value enhancing and strategic opportunities."
Financial Results for the Second Quarter Ended June 30, 2016
Research and development expense was $361,728 for the three months ended June 30, 2016 and mainly represents amortization of capitalized license costs of approximately $257,000, accrued license fees to MD Anderson for approximately $39,000, and approximately $33,000 related to MD Anderson sponsored research.
Research and development expense was $376,728 for the six months ended June 30, 2016 and mainly represents amortization of capitalized license costs of approximately $257,000, accrued license fees to MD Anderson for approximately $54,000, and approximately $33,000 related to MD Anderson sponsored research. We expect to incur increased research and development costs in the future as our product development activities expand.
General and administrative expense was $618,001 for the three months ended June 30, 2016. The expense mainly included payroll, travel, insurance, professional fees to our consultants, attorneys and accountants for services related to our becoming a publicly traded company and related filing fees.
General and administrative expense was $923,572 for the six months ended June 30, 2016. The expense mainly included payroll, travel, insurance, professional fees to our consultants, attorneys and accountants for services related to our becoming a publicly traded company and related filing fees. We expect to incur increased general and administrative expenses over time as the Company increases its product development activity.
Interest expense included expense accrued on our convertible promissory notes issued in 2015 and 2016 bearing interest at the rate of 8% per annum.
The Company’s net loss for the three month period ended June 30, 2016 was $995,616 and was $1,327,857 for the six month period ended June 30, 2016.
As of June 30, 2016, we had $7,244,684 in cash. During the period from January 1, 2016 through May 2, 2016, we sold 234,296 common shares for $702,888. On May 31, 2016, we completed our initial public offering, pursuant to which we sold 1,540,026 shares of our common stock at $6.00 per share for net proceeds of $8,464,183 after deducting underwriting discounts and commissions and direct offering expenses payable by us.
Net cash used in operating activities was $1,645,901 for the six months ended June 30, 2016 and mainly included payments made for payroll, travel, insurance and professional fees to our consultants, attorneys and accountants for services related to our becoming a publicly traded company and related filing fees, along with payments made to MD Anderson for license and maintenance fees. Additionally, prepayments were made for directors and officers insurance.
Net cash provided by investing activities was $362 for the six months ended June 30, 2016 and represents the cash amount acquired through the acquisition of Moleculin, LLC.
Net cash provided by financing activities was $8,862,132 for the six months ended June 30, 2016. We received $8,464,183 net proceeds from our IPO stock issuance, $702,888 from issuance of common shares at $3 per share, and $165,000 from issuance of convertible notes. Net cash used in financing activities included approximately $470,000 for payments of notes payable.

VBL Therapeutics Announces Second Quarter 2016 Financial Results and Provides Business Update

On August 15, 2016 VBL Therapeutics (NASDAQ:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported financial results and provided a business update for the second quarter and six month period ended June 30, 2016 (Press release, VBL Therapeutics, AUG 15, 2016, View Source;p=irol-newsArticle&ID=2195332 [SID:1234514575]).

"The second quarter of 2016 was marked by further progress in the clinic with our lead oncology product candidate, VB-111, which has shown evidence of benefit in multiple tumor types," said Dror Harats, Chief Executive Officer of VBL Therapeutics. "The positive results we announced during ASCO (Free ASCO Whitepaper) in platinum resistant ovarian cancer and in rGBM add to the growing body of evidence suggesting that VB-111 has potent anti-tumor activity, and importantly, that it appears to be extending survival in these difficult to treat patients."

"Our ongoing Phase 3 randomized controlled GLOBE study of VB-111 in combination with Avastin is proceeding on track," continued Dr. Harats. "The trial, which is enrolling patients in the U.S., Canada and Israel, is covered by a Special Protocol Assessment (SPA). Our goal is to conduct an event-driven interim analysis according to the study protocol, and we think this will likely happen in the first half of 2017. We also strengthened our balance sheet during the second quarter, with the successful completion of a common stock offering, raising net proceeds of approximately $21.9 million."

Second Quarter and Year-to-Date Clinical and Corporate Highlights:

Presented positive clinical data on VB-111 in platinum resistant ovarian cancer during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
VB-111 demonstrated a statistically significant increase in overall survival in platinum resistant ovarian cancer at therapeutic vs. low dose level (810 days vs. 172 days, p=0.042)
60% durable response rate (as measured by reduction in CA-125 biomarker) observed with VB-111, approximately 2x the historical response with Avastin plus chemotherapy in ovarian cancer
Clinical data in ovarian cancer supported by immuno-therapeutic effect observed in biopsies following treatment with VB-111
At ASCO (Free ASCO Whitepaper), presented new data in recurrent glioblastoma (rGBM), comparing clinical outcomes with VB-111 with pooled data from 8 historical studies that investigated Avastin (bevacizumab)
Median overall survival for patients on continuous exposure of VB-111 was 59 weeks, compared with 32 weeks in historical pooled Avastin trials (p= 0.0295).
12-Month overall survival was 57% in patients on continuous exposure of VB-111, compared with 24% in historical pooled Avastin trials (p=0.03).
Results for VB-201 and VB-703 for the Treatment of Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis were published in Digestive Diseases & Sciences Magazine.
Appointed Rachel W. Humphrey, MD, Ph.D., an expert in oncology drug development and one of the pioneers of the immune-oncology field, to head the VBL’s scientific advisory board.
Strengthened cash position by raising approximately $21.9 million in net proceeds in a registered direct public offering.
Second Quarter Ended June 30, 2016 Financial Results:

R&D Expenses: Research and development expenses (net) were $2.2 million for the second quarter of 2016, compared to $2.0 million in second quarter of 2015.
G&A Expenses: General and administrative expenses for the second quarter of 2016 were $1.1 million, compared to $1.1 million in the second quarter of 2015.
Net Loss: Net loss for the second quarter of 2016 was $3.3 million, or ($0.14) per share, compared to a net loss of $3.0 million, or ($0.15) per share in the second quarter of 2015.
Cash Position: At June 30, 2016, cash, cash equivalents and short-term bank deposits totaled $51.6 million, inclusive of the public offering of common stock mentioned above. The Company expects that these funds will support operating expenses and capital expenditure requirements into 2019 and are expected to be sufficient to enable completion of the on-going Phase 3 registration clinical trial of VB-111 in rGBM, the Phase 2 clinical trial of VB-111 in thyroid cancer and the potential registration clinical trial for VB-111 in ovarian cancer.
Six Months Ended June 30, 2016 Financial Results:

R&D Expenses: Research and development expenses (net) were $6.2 million for the six month period of 2016, compared to $4.0 million in same period of 2015.
G&A Expenses: General and administrative expenses for the six month period of 2016 were $1.9 million, compared to $1.9 million in the same period of 2015.
Net Loss: Net loss for the six months of 2016 was $8.0 million, or ($0.35) per share, compared to a net loss of $5.9 million, or ($0.30) per share in the first six months of 2015.

Onconova Therapeutics, Inc. Reports Recent Business Highlights and Second Quarter 2016 Financial Results

On August 15, 2016 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported a corporate update and reported financial results for the second quarter ended June 30, 2016 (Press release, Onconova, AUG 15, 2016, View Source [SID:1234514563]).

"We are encouraged by the progress of our global Phase 3 trial of our lead product candidate, rigosertib, for patients with myelodysplastic syndromes (MDS). The INSPIRE trial is actively enrolling patients in the U.S., Europe and Japan, and we have recently opened trial sites in Israel and Australia, bringing us more than two-thirds of the way to our target of approximately 135 sites worldwide. The enrollment of patients in Japan by our Japan/Korea partner, SymBio Pharmaceuticals, is further accelerating this important pivotal trial," said Ramesh Kumar, Ph.D., President and CEO of Onconova. "As a result of the completion of our oversubscribed rights offering in July, we believe we are positioned to deliver multiple key milestones in 2016 and 2017, including opening additional INSPIRE trial sites, pre-planned interim analysis and enrollment of approximately 225 patients. Finally, we have initiated discussions with U.S. and European regulatory authorities towards formal End-of-Phase 2 meetings to define the pathway forward for further development of oral rigosertib. We intend to provide an update on these discussions later this year."

Recent Business Highlights:

Completion of $17.4 Million Oversubscribed Financing

On July 29, 2016, Onconova closed its oversubscribed rights offering. Although the number of units able to be sold was capped at a maximum of 4,256,186 units (or approximately $17.4 million in gross proceeds), there was a total demand for approximately 4.9 million units in the rights offering.
Overall, 4,256,186 units consisting of a total of 3,599,786 shares of common stock, pre-funded warrants to purchase an additional 656,400 shares of common stock, and 3,192,022 tradable warrants were issued in this offering.
Including the net proceeds from the rights offering of approximately $15.8 million, Onconova had cash and cash equivalents of approximately $27.6 million at July 31, 2016.
Progress in INSPIRE Pivotal Trial of Rigosertib in Higher-risk MDS (HR-MDS)

The global INSPIRE trial is now enrolling patients in the United States, Europe and Japan. As of July 31, 2016, 103 sites, including 27 in the U.S., were open and recruiting patients. The first patient in Japan was enrolled in the trial in July by our partner, SymBio Pharmaceuticals, Inc.
Progress in Oral Rigosertib Combination with Azacitidine

Updated results from the Phase 2 trial 09-08 were presented in June 2016 at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper). Notably, the interim overall response rate was 77% (23 of 30 patients) among evaluable first- or second-line HR-MDS patients treated with oral rigosertib in combination with azacitidine. This trial is now fully enrolled and End-of-Phase 2 meetings to discuss the next stage of development with regulatory authorities in the U.S. and Europe are expected to occur in the second half of 2016.
Upcoming Events

Enrollment of patients in Israel, Australia and Canada for INSPIRE trial: 3Q2016

Key Opinion Leader investor event to discuss the potential future applications of the RAS-directed Mechanism of Action in oncology and for rigosertib: 3Q2016

End-of-Phase 2 meeting with FDA and European authorities to discuss trial results and future development plan for oral rigosertib in combination with azacitidine: 2H2016
Second Quarter 2016 Financial Results

Cash, cash equivalents, and marketable securities as of June 30, 2016 totaled $12.8 million, compared to $19.8 million as of December 31, 2015.
Total net revenue was $2.2 million for the second quarter of 2016 and $3.7 million for the six months ended June 30, 2016, compared to $0.1 million and $0.2 million, respectively, for the comparable periods in 2015.
Research and development expenses were $5.6 million for the second quarter of 2016 and $11.4 million for the six months ended June 30, 2016, compared to $6.5 million and $16.0 million, respectively, for the comparable periods in 2015.
General and administrative expenses were $2.1 million for the second quarter of 2016 and $5.3 million for the six months ended June 30, 2016, compared to $2.6 million and $5.5 million, respectively, for the comparable periods in 2015.

Mirna Therapeutics Reports Second Quarter 2016 Financial Results and Program Updates

On August 15, 2016 Mirna Therapeutics, Inc. (Nasdaq:MIRN), a clinical stage biopharmaceutical company developing a pipeline of microRNA-based oncology therapeutics, reported financial results for the second quarter of 2016 and provided an update on recent developments (Press release, Mirna Therapeutics, AUG 15, 2016, View Source [SID:1234514553]).

MRX34 CLINICAL PROGRAM AND SECOND QUARTER UPDATE

Presented clinical data of MRX34 at ASCO (Free ASCO Whitepaper) 2016. In an oral presentation, investigators reported on the final dose-escalation results from the first-in-human Phase 1 trial of MRX34, highlighting the safety profile, pharmacodynamic evidence of activity, and multiple clinical responses in cancer patients with a variety of advanced solid tumors.
Data highlights included four confirmed partial responses for up to 50+ weeks in duration in patients with late-stage, metastatic hepatocellular carcinoma cancer or HCC (liver cancer), renal cell carcinoma or RCC (kidney cancer) and acral melanoma (a rare and difficult-to-treat form of skin cancer). Stable disease was also observed in an additional 15 patients for more than four cycles (approximately three months) of therapy, including a small cell lung cancer (SCLC) patient who showed stable disease for more than one year on MRX34 as fourth line therapy.

As of the ASCO (Free ASCO Whitepaper) presentation, three patients had experienced possible immune-mediated serious adverse events (SAEs) after receiving MRX34. These previously reported events included enterocolitis, systemic inflammatory response syndrome, and pneumonitis/colitis. The first two patients recovered; the patient experiencing pneumonitis/colitis subsequently died.

Clinical Update. In early August, a recently enrolled acral melanoma patient experienced an SAE of increased ALT and AST liver function tests, determined likely to be due to acute hepatitis, with subsequent liver failure leading to death. The event was deemed possibly related to MRX34 and reported to the FDA and Korean regulatory authority.
The timing and pattern of response to treatment with MRX34 and the associated safety profile suggest a potential immune component to MRX34 activity.

Plan to continue the expansion phase of the ongoing Phase 1 study. Enrollment efforts are focused on patients with cancer types where confirmed responses have been observed as well as others where miR-34 has shown biological relevance. The Company had planned to initiate Phase 2 trials in RCC and melanoma by the end of 2016. However, it is now planned to let the results from the Phase 1 expansion cohorts and the translational medicine study guide the next steps in development of MRX34.
Preparing to launch translational medicine trial in late 2016. This study is intended to develop deeper insights into the mechanism of action of MRX34 in metastatic melanoma patients and identify potential biomarkers of drug activity and treatment response. The study is planned to include serial tumor biopsies as well as liquid biopsies for cell-free DNA and exosomal RNA analysis.
Preclinical studies underway, evaluating potential of combination regimens to enhance effectiveness of standard cancer therapies. Mirna researchers presented in vitro findings at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2016 annual meeting demonstrating the synergistic anticancer effects between MRX34 and platinum and other commonly used cytotoxic chemotherapy drugs across a range of non-small cell lung cancer (NSCLC) cell lines. Synergistic anticancer effects were also shown between MRX34 and tyrosine kinase inhibitors, suggesting the potential for combination therapies that include MRX34 with other standard of care cancer therapeutics.
CORPORATE UPDATES

Appointed Dr. Vincent J. O’Neill as the Company’s Chief Medical Officer. Dr. O’Neill, a medical oncologist, joined Mirna with 15 years of therapeutic and diagnostic product development experience, most recently serving as Chief Medical Officer at Exosome Diagnostics. Previous roles included senior leadership positions at Sanofi, Genentech and GlaxoSmithKline.
Appointed Dr. Perry Nisen to the Board of Directors. Dr. Nisen is currently the Chief Executive Officer and Donald Bren Chief Executive Chair of the Sanford Burnham Prebys Medical Discovery Institute. Previously, he served as Senior Vice President of Science and Innovation at GlaxoSmithKline (GSK), where he was integral to the discovery, development, and commercialization of a vast portfolio of oncology drugs. Earlier roles included Senior Vice President and Oncology Therapy Area Head at GSK and Divisional Vice President of Cancer Research and Oncology Development at Abbott Laboratories.
SECOND QUARTER 2016 FINANCIAL RESULTS

Cash Position and Guidance: Cash, cash equivalents, and marketable securities totaled $72.6 million as of June 30, 2016, compared to $89.7 million as of December 31, 2015. The Company has no debt. Based on the current operating plan, the Company expects that current cash resources will be sufficient to meet operating requirements into 2018.
Research and development expenses: Research and development expenses in the second quarter of 2016 were $3.7 million and $8.2 million, respectively, for the three and six months ended June 30, 2016, compared to $4.5 million and $7.9 million during the comparable periods in 2015. The decrease for the three months ended June 30, 2016 compared to the same period in 2015 was primarily attributable to higher costs associated with our Phase 1 clinical trial for our lead product candidate MRX34, specifically adding additional sites and upfront drug costs which were incurred in 2015. This decrease in 2016 was partially offset by an increase in employee compensation, benefits and stock compensation.
The increase for the six months ended June 30, 2016 is primarily attributable to higher compensation, benefits and stock compensation expense due to a higher headcount. The increase was largely offset by higher costs associated with our Phase 1 trial in the prior year.

General and Administrative Expenses: General and administrative expenses in the second quarter of 2016 were $2.0 million and $4.2 million, respectively, for the three and six months ended June 30, 2016, compared to $1.2 million and $2.1 million during the comparable periods in 2015. The increase in general and administrative expenses was primarily attributable to increased employee compensation expense due to a higher headcount and higher outside professional and consulting costs, the majority of which were costs to comply with public company operating and reporting requirements.
Net Loss: Net loss was approximately $5.6 million for the second quarter of 2016 and $12.2 million for the six months ended June 30, 2016, compared to a net loss of $5.7 million and $10.0 million for the comparable periods in 2015. The results included non-cash, stock-based related compensation charges of $243,000 and $689,000 for the second quarter and six months ended June 30, 2016 and $217,000 and $351,000 for the comparable periods in 2015.