On August 15, 2016 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the second quarter ended June 30, 2016 (Filing, Q2, Cleveland BioLabs, 2016, AUG 15, 2016, View Source [SID:1234514546]).

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Cleveland BioLabs reported a $(1.9) million net loss, excluding minority interests, for the second quarter of 2016, or $(0.17) per share, compared to a net loss, excluding minority interests, of $(4.4) million, or $(1.12) per share, for the same period in 2015. Net loss, excluding minority interests, for the first six months of 2016 was $(2.6) million, or $(0.23) per share, compared to a net loss, excluding minority interests, of $(8.1) million, or $(2.25) per share, for the same period in 2015. The reduction in net loss for both periods due to operating results was attributable to increased revenues and lower costs with the most significant being a reduction in the non-cash adjustment to our warrant liabilities and reduced operating costs aligned with our streamlined focus primarily on pursuing a pre Emergency Use Authorization ("pre-EUA") for entolimod with the U.S. Food and Drug Administration ("FDA"). Additionally, the weighted average outstanding shares for both periods significantly increased, which thereby lowers the per share results, due to the issuance of approximately 6.5 million shares in July 2015.

As of June 30, 2016, the Company had $16.4 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund the Company’s operating requirements beyond one year.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "Since our last update in March of this year, CBLI has submitted a proposal to the FDA to address their request for demonstration of in vivo biocomparability between the entolimod drug formulation proposed for use under the pre-EUA and the drug formulation used in previously conducted preclinical and clinical studies. We have subsequently engaged in active discussions with the FDA regarding the proposed study design, in which the FDA has requested side-by-side analytical comparability data before initiating an in vivo biocomparability study. This analytical analysis is currently in progress with an expected completion date in the fourth quarter of 2016 after which the biocomparability study may start. Once we have finalized the biocomparability study design and confirmed timing of the study with our vendors, we will update guidance on this point. Preliminarily, we expect the biocomparability study will require approximately 6 months to complete."

"In addition, we are evaluating steps needed to file a Marketing Authorization Application ("MAA") for entolimod as a medical radiation countermeasure with the European Medicines Agency ("EMA"). As a prelude to filing an MAA, the EMA requires an agreement between the agency and the sponsor on a pediatric investigational plan ("PIP"), which recently has been filed with the EMA. We cannot currently estimate when an agreement on the PIP will be reached or if any additional studies will be required for an MAA submission."

"Clinical oncology studies with entolimod, CBLB612 and Mobilan are progressing in the Russian Federation," added Dr. Kogan. "The Phase 2 study of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer has recruited 35 patients to date. Recruitment was completed in a Phase 2 study of CBLB612 as myelosuppressive prophylaxis in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy. The database for this study is being prepared for analysis. And finally, Panacela Labs continues dosing in a Phase 1 study with Mobilan evaluating single injections

administered directly into the prostate of patients with prostate cancer. All of these studies are supported by development contracts with the Russian Federation Ministry of Industry and Trade, or MPT."

Further Financial Results

Revenue for the second quarter of 2016 increased to $0.6 million compared to $0.3 million for the first quarter of 2015. Revenue for the first six months of 2016 increased to $1.4 million compared to $0.9 million for the first quarter of 2015. These increases were primarily attributable to work performed under contracts from the Department of Defense for the continued development of the entolimod biodefense indication.

Research and development costs for the first quarter of 2016 decreased to $1.3 million compared to $1.6 million for the first quarter of 2015. Research and development costs for the first six months of 2016 were approximately the same at $3.2 million compared to the first six months of 2015.

General and administrative costs for the first quarter of 2016 decreased to $0.8 million compared to $1.6 million for the first quarter of 2015. General and administrative costs for the first six months of 2016 decreased to $2.0 million compared to $3.9 million for the first quarter of 2015. This decrease was primarily attributable to reductions in personnel and outside professional costs.

As of June 30, 2016 the Company had approximately 11 million shares of common stock outstanding. In addition, the Company has approximately 0.3 million shares of common stock reserved for issuance pursuant to outstanding stock options with a weighted average exercise price of $42.01 and approximately 2.1 million shares of common stock reserved for issuance pursuant to outstanding warrants exercisable at a weighted average price of $11.04.

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 (Filing, Q2, Celsion, 2016, AUG 15, 2016, View Source [SID:1234514545]).

"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 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.

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On August 15, 2016 Celsion Corporation (NASDAQ:CLSN) reported updated results from its final retrospective analysis of the Company’s 701-patient HEAT Study of ThermoDox, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC) (Press release, Celsion, AUG 15, 2016, View Source [SID:1234514543]). 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).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Additional findings from this most recent analysis specific to the Chinese patient cohort of 223 patients are summarized below:

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. The clinical benefit seen in the ITT Chinese patient cohort further confirms the importance of RFA heating time as 72% of patients in this large patient cohort in China received an optimized RFA treatment.
"Data from the HEAT Study have consistently been a foundation and provides additional evidence for our thesis that ThermoDox, when combined with RFA standardized to a minimum of 45 minutes for intermediate size lesions has the potential to significantly improve survival in primary liver cancer, where the current overall survival rate is far too short," stated Nicholas Borys, M.D., Celsion’s senior vice president and chief medical officer. "These findings, if borne out in our ongoing OPTIMA trial, will position ThermoDox as a potentially curative treatment in primary liver cancer."

"We are delighted to present our investors and the medical community with the findings from the final data sweep from the HEAT Study which reinforces the substantial and mounting support for our ongoing global Phase III OPTIMA Study," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Particularly, with the growing incidence of primary liver cancer in China representing approximately 50% of the 850,000 cases diagnosed annually, the data generated from the Chinese subgroup underscore the importance of ThermoDox and the role that it will play as a first line therapy for this, the largest unmet medical need in oncology. Along with our China focused manufacturing strategy, the results from the HEAT Study will support our regulatory and long-term commercialization strategy for ThermoDox in this important region."

The OPTIMA Study is a pivotal, double-blind, placebo-controlled Phase III clinical trial, and is expected to enroll up to 550 patients at up to 75 sites in the North America, Europe, China and Asia Pacific. As of July 31, 2016, the study has been successfully enrolling patients at more than 57 clinical sites in 13 different countries. In December 2015, Celsion announced that it had received a Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the OPTIMA Study at up to 15 additional clinical sites in China, the country where approximately 50% of the 850,000 new cases of primary liver cancer are diagnosed each year and where the Company aims to enroll more than 200 patients in the China territory, the minimum number required by the CFDA to file a New Drug Application (NDA), assuming positive clinical results.