On August 15, 2016 Syros Pharmaceuticals (NASDAQ:SYRS) reported financial results for the second quarter ended June 30, 2016, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, AUG 15, 2016, View Source;p=irol-newsArticle&ID=2195352 [SID:1234514589]).

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"The first half of 2016 has been a period of tremendous growth for Syros," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We transitioned to a clinical-stage company with the FDA’s acceptance of the IND for our lead program SY-1425 and with the opening of our Phase 2 trial for patient enrollment. We also became a publicly traded enterprise with the successful completion of our IPO, which we expect to provide funding for us to drive forward our two lead programs to clinical data readouts and further enhance our gene control drug discovery and development platform through mid-2018. Importantly, we accomplished these milestones while progressing our pioneering platform to discover and develop medicines that control the expression of disease-driving genes."

Upcoming Milestones

Phase 2 trial of SY-1425, a first-in-class selective retinoic acid receptor alpha (RARα) agonist, is on track to begin dosing genomically defined relapsed or refractory AML and relapsed high-risk MDS patients with the RARA biomarker, which Syros discovered, in the third quarter of 2016. Patients are currently being screened for enrollment in the trial.
Phase 1/2 trial of SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, remains on track to begin in the first half of 2017, with the in-life portion of the Good Laboratory Practice (GLP) toxicology studies now successfully completed.
Recent Platform and Pipeline Highlights

In June 2016, Syros presented data on its two lead programs, SY-1425 and SY-1365, at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Copenhagen, Denmark. In preclinical studies, SY-1425 was observed to inhibit the growth of cancer cells and prolong survival in in vivo models of AML with the RARA biomarker, while SY-1365 was observed to selectively kill acute leukemia cells over non-cancerous cells and induce complete tumor regression and a significant survival benefit in in vivo models of AML.
In May 2016, the Company announced the acceptance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration to advance SY-1425 into a Phase 2 clinical trial in patients with relapsed or refractory AML and relapsed high-risk MDS with the RARA biomarker.
In April 2016, Syros presented additional preclinical data on both SY-1425 and SY-1365 at the American Association of Cancer Research Annual Meeting in New Orleans.
Recent Corporate Highlights

In July 2016, Syros completed its initial public offering, raising approximately $57.5 million in gross proceeds through the sale of 4,600,000 shares at an offering price of $12.50 per share – including 600,000 shares of common stock issued upon the full exercise by the underwriters of their option to purchase additional shares.
In June 2016, the Company expanded its Board of Directors with the appointment of industry leader Sanj K. Patel, Chief Executive Officer and Chairman of Kiniksa Pharmaceuticals and former President and Chief Executive Officer of Synageva BioPharma Corp.
Second Quarter 2016 Financial Results

Cash and cash equivalents as of June 30, 2016 were $50.1 million, compared with $35.9 million on December 31, 2015. Cash and cash equivalents as of June 30, 2016 did not include total net proceeds of approximately $49.9 million from the Company’s initial public offering of common stock, which was completed in July 2016.
For the second quarter 2016, Syros reported a net loss of $12.0 million, or $5.42 per share, compared to a net loss of $6.1 million, or $4.16 per share, for the same period in 2015.
Research and development (R&D) expenses for the second quarter 2016 were approximately $9.5 million, including stock-based compensation expense of $0.9 million, compared to $5.4 million, including stock-based compensation expense of $0.5 million, for the same period in 2015. The increase was largely due to increased external costs associated with advancing the Company’s pipeline, as well as personnel expense and stock-based compensation expense.
General and administrative (G&A) expenses for the second quarter 2016 were approximately $2.5 million, including stock-based compensation expense of $0.2 million, compared to $1.0 million, including stock-based compensation expense of $0.1 million for the same period in 2015. The increase was largely due to increased personnel expense and stock-based compensation expense, as well as increased professional fees.

Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection, reported financial results for the nine months ended June 30, 2016 (Press release, Aeolus, AUG 15, 2016, View Source [SID:1234514588]).

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The Company reported a net loss of approximately $872,000, or $0.01 per share for the three months ended June 30, 2016. This compares to a net loss of approximately $784,000, or $0.01 per share for the three months ended June 30, 2015. For the nine months ended June 30, 2016, the Company reported a net loss of approximately $5,021,000, or $0.03 per share. This compares to a net loss of approximately $2,194,000, or $0.02 per share for the nine months ended June 30, 2015. The increase in net loss during the nine months ended June 30, 2016 was primarily attributable to a $2,486,000 non-cash expense related to a deemed dividend for the Company’s Series C Preferred Stock. The net operating loss for the nine months ended June 30, 2016 was $2,250,000 or $0.02 per share.

"With the work completed this quarter and over the term of our partnership with BARDA, we are on the brink of launching the clinical development of AEOL 10150. Thanks to the support of the BARDA Contract, we have reduced the cost of manufacturing AEOL 10150 by 90 percent, manufactured pilot scale GMP batches and, this past quarter, extended stability out to 3 years for the API and 2 years for the final drug product," stated John L. McManus, President and Chief Executive Officer. "Over the next two quarters, we anticipate filing INDs and initiating clinical studies in Idiopathic Pulmonary Fibrosis and cancer radiation therapy, which, in addition to launching our development efforts in two important commercial indications, will also provide the initial human safety data required for our Lung ARS medical countermeasure development program funded by BARDA."

Results of Operations for the Three Months Ended June 30, 2016

Revenue for the three months ended June 30, 2016 was approximately $660,000, which compares to approximately $63,000 for the three months ended June 30, 2015. The revenue is from the BARDA Contract. Higher revenue in 2016 reflects the timing of the initiation of program items and revenue recognition under accounting rules. Under the BARDA Contract, we generate contract revenue from a cost-plus fee arrangement. Revenues on reimbursable contracts are recognized as costs are incurred, which is based on allowable costs incurred during the period, plus any recognizable earned fee. We consider fixed fees under cost-plus fee contracts to be earned in proportion to the allowable costs incurred in performance of the contract.

Research and development expenses increased to approximately $904,000 for the three months ended June 30, 2016 from approximately $269,000 for the three months ended June 30, 2015. The increase is primarily attributable to the timing of work related to the BARDA Contract.

General and administrative expenses increased to approximately $628,000 for the three months ended June 30, 2016 from approximately $578,000 for the three months ended June 30, 2015. The increase is primarily attributable to increased investor relations costs and legal fees.

Results of Operations for the Nine Months Ended June 30, 2016

Revenue for the nine months ended June 30, 2016 was approximately $1,530,000, which compares to approximately $2,177,000 for the nine months ended June 30, 2015. The revenue is from the BARDA Contract. Lower revenue in 2016 reflects the timing of the initiation of program items and revenue recognition under accounting rules.

Research and development expenses decreased to approximately $1,897,000 for the nine months ended June 30, 2016 from approximately $2,539,000 for the nine months ended June 30, 2015. The decrease is primarily attributable to the timing of work related to the BARDA Contract.

General and administrative expenses increased to approximately $1,883,000 for the nine months ended June 30, 2016 from approximately $1,832,000 for the nine months ended June 30, 2015 due to higher legal fees, investor relations cost and insurance premiums.

As of June 30, 2016, the Company had approximately $3,756,000 in cash and cash equivalents and 152,085,825 common shares outstanding. The Company had accounts receivable of $742,000 and accounts payable of $661,000 on June 30, 2016.

Aeolus has filed today with the SEC its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. Aeolus urges its investors to read this quarterly filing as well as its Annual Report on Form 10-K, also filed with the SEC, for further details concerning the Company. The Quarterly Report on Form 10-Q and the Annual Report on Form 10-K are also available on the Company’s website, at www.aolsrx.com.

About AEOL 10150

AEOL 10150 is a broad-spectrum catalytic antioxidant specifically designed to neutralize reactive oxygen and nitrogen species. The neutralization of these species reduces oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure. AEOL 10150 may have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation in the treatment of oncology.

AEOL 10150 has performed well in animal safety studies, was well tolerated in two human clinical trials and has demonstrated statistically significant survival efficacy in multiple Radiation-Induced Lung Fibrosis ("Lung ARS") studies in animals. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event. Aeolus has received "Orphan Drug" designation for the use of AEOL 10150 in treating Lung ARS and Idiopathic Pulmonary Fibrosis and has filed an IND to allow for human safety testing of the compound in healthy volunteers. AEOL 10150 is also currently in development for use in Idiopathic Pulmonary Fibrosis and as both a therapeutic and prophylactic drug in cancer patients.

On August 15, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported a general business update and reported its financial results for the second quarter and six months ended June 30, 2016 (Press release, Heat Biologics, AUG 15, 2016, View Source [SID:1234514586]).

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"We are pleased to report a number of important scientific, clinical and financial developments at the company," said Jeff Wolf, Heat’s Founder and CEO. "First, the preclinical findings demonstrating that our ComPACT technology secreting the co-stimulator OX40L significantly enhanced tumor rejection were published in the journal, ‘Cancer Immunology Research.’ Additionally, we reported encouraging interim study findings from our Phase 1b trial evaluating HS-110 in combination with nivolumab (Opdivo), a Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, for the treatment of non-small cell lung cancer."

"We remain focused on driving shareholder value and minimizing dilution. We have implemented a number of cost-saving measures to help ensure we achieve important data readouts expected in the fourth quarter with current cash on-hand. Furthermore, I am pleased to report we have generated approximately $2.0 million in additional cash from the exercise of warrants. Significantly, we have also regained compliance with NASDAQ’s minimum closing bid price requirement, which alleviates the immediacy of effecting a reverse stock split."

"Overall, we remain encouraged by the outlook for the business and the growing interest from within the industry to utilize our platform technology with checkpoint inhibitors and other immunotherapies to activate a patient’s immune system against cancer. Importantly, our allogeneic cell-based immunotherapy has the potential to offer a broader, off-the-shelf solution that addresses many of the past challenges that have plagued the immuno-oncology market."

Recent Developments & Second Quarter 2016 Corporate Highlights

Heat remains on track to report topline data in the fourth quarter from its Phase 2 trial evaluating HS-410 for the treatment of non-muscle invasive bladder cancer (NMIBC) and its Phase 1b trial evaluating HS-110 in combination with an anti-PD-1 checkpoint inhibitor for the treatment of non-small cell lung cancer (NSCLC).

In July, Heat announced that preclinical findings from its ComPACT platform technology were published online in the journal "Cancer Immunology Research." Heat demonstrated that its ComPACT technology secreting the co-stimulator OX40L significantly enhanced tumor rejection in two cancer tumor types compared to OX40 agonist antibody treatment. Heat also reported that ComPACT-enhanced antigen-specific T cell infiltration into tumors improved memory T cell responses and demonstrated greater specificity than OX40 agonist antibody treatments. Furthermore, the findings also showed that the ComPACT platform can be adapted to secrete other costimulatory molecules, including TL1A, 4-1BBL and ICOSL.

In June, Heat reported interim study findings from its Phase 1b trial evaluating HS-110 in combination with nivolumab for the treatment of NSCLC. The findings suggested that the addition of HS-110 to nivolumab does not alter the nivolumab safety profile to-date. In addition, case studies of three trial patients (one non-responder and two responders) were characterized. While all three patients showed a decrease in immune cell PD-1 expression, which is consistent with nivolumab’s mechanism of action, both responders also showed a decrease in immunosuppressor cells, as well as increases in activated effector T cells in the peripheral blood. Furthermore, the two responders showed an increase in CD8+ T cells in biopsy samples after treatment with HS-110 + nivolumab. These early data appear to suggest that HS-110 in combination with nivolumab may improve response rates for patients with "cold tumors," who have historically not responded to checkpoint inhibitors alone.

In June, Heat presented a poster at the ASCO (Free ASCO Whitepaper) Annual Meeting reviewing the design and endpoints for the ongoing Phase 1b trial of HS-110 in combination with nivolumab.

In April, Heat presented three posters at the AACR (Free AACR Whitepaper) Annual Meeting. In the poster entitled "Phase I/II Study of Patients with NMIBC Treated with Vesigenurtacel-L (HS-410) with or without BCG," Heat reported that no additional recurrences had been reported to-date, with all patients at least 18 months out from enrollment. In another poster, Heat reported initial preclinical results from its collaboration with OncoSec Medical Incorporated. In the third poster, Heat reported positive preclinical data on its next generation ComPACT platform technology.

In April, Heat implemented cost-saving measures and a focused corporate strategy to achieve important data readouts in the fourth quarter with its current cash on-hand.

In April, Heat appointed John Prendergast, Ph.D., to its Board of Directors.
Second Quarter 2016 Financial Highlights

Research and development (R&D) expenses decreased to approximately $0.5 million in the second quarter of 2016 compared to approximately $0.6 million in the second quarter of 2015, a decrease of approximately $0.1 million. The decrease is primarily attributable to reductions in non-cash stock compensation expense related to equity grants awarded to one of our Scientific Advisory Board members in 2015.

Clinical and regulatory expenses decreased to approximately $1.3 million in the second quarter of 2016 compared to approximately $3.4 million in the second quarter of 2015, a decrease of approximately $2.1 million. The decrease is primarily attributable to reductions in clinical trial execution costs.

General and administrative (G&A) expenses increased to approximately $1.1 million in the second quarter of 2016 compared to approximately $0.9 million in the second quarter of 2015, an increase of approximately $0.2 million. The increase is primarily attributable to separation expenses related to the departure of two of our former executive officers, as well as other incremental operating expenses.

Net loss for the second quarter of 2016 was $3.0 million compared to a net loss of $4.9 million for the second quarter of 2015.
Six Months Ended June 30, 2016 Financial Highlights

R&D expenses decreased to approximately $1.0 million for the six months ended June 30, 2016 compared to approximately $1.1 million for the six months ended June 30, 2015, a decrease of approximately $0.1 million. The decrease is attributable to reductions in patent, license and other professional fees, as well as reductions in compensation costs attributable to deferral in salary as part of our cost-savings initiatives.

Clinical and regulatory expenses decreased to approximately $4.5 million for the six months ended June 30, 2016 compared to approximately $5.5 million for the six months ended June 30, 2015, a decrease of approximately $1.0 million. The decrease is primarily attributable to reductions in clinical trial execution costs.

G&A expenses decreased to approximately $2.1 million for the six months ended June 30, 2016 compared to approximately $2.2 million for the six months ended June 30, 2015, a decrease of approximately $0.1 million. The decrease is primarily attributable to reductions in professional services as we bring more services in-house.

Net loss for the six months ended June 30, 2016 was $7.8 million compared to a net loss of $8.9 million for the six months ended June 30, 2015.

Cash and cash equivalents totaled approximately $7.1 million at June 30, 2016 compared to cash, cash equivalents and short-term investments totaled approximately $11.6 million at December 31, 2015. This does not include approximately $2.0 million raised from the exercise of warrants subsequent to June 30, 2016.
About Heat Biologics, Inc.

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.

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]).

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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.