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.

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]).

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"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.

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]).

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"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.