On March 27, 2018 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the year ended December 31, 2017 and provided an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin, and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein (Press release, Celsion, MAR 27, 2018, View Source [SID1234525008]). The Company’s lead program is ThermoDox, which is currently in Phase III development for the treatment of primary liver cancer. The Company’s immunotherapy candidate, GEN-1, is currently in Phase I/II development for the localized treatment of ovarian cancer.

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"Celsion had an outstanding year in 2017, making meaningful progress with our ongoing development programs for ThermoDox and GEN-1, as well as strengthening our balance sheet. Entering 2018 with more than $25 million in cash , we are well positioned with sound fundamentals, the right resources, and capital sufficient to complete enrollment of our ongoing global, pivotal Phase III OPTIMA Study in primary liver cancer, and continue the trial through the first preplanned, interim efficacy analysis expected in the first half of 2019," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Our equally important efforts in immunotherapy are generating impressive results. During 2017, we reported data from our Phase 1b immunotherapy program (the OVATION I Study) in ovarian cancer. These data have provided key insights into GEN-1’s clinical and safety profile and reinforce our confidence in GEN-1’s potential to serve as a highly effective first-line therapy in newly diagnosed patients with ovarian cancer. We look forward to reporting early clinical findings and translational data from the first cohort of our 90 patient, randomized Phase I/II OVATION II Study in the second half of 2018."

Recent Developments

ThermoDox

Presentation of ThermoDox HEAT Study Manuscript by Lead Author, Dr. Won Young Tak, at Korean Liver Cancer Association’s 12th Annual Scientific Meeting. On Feb. 12, 2018, the Company announced that an abstract discussing the Company’s Phase III HEAT study evaluating ThermoDox in combination with radiofrequency ablation (RFA) was one of six selected for presentation as part of the lecture of the Presidential Selection at the Korean Liver Cancer Association’s 12th Annual Scientific Meeting in Seoul, South Korea. Dr. Tak’s presentation highlighted learnings from the Company’s 701 patient HEAT Study and included results from simulation studies and findings from the post hoc subgroup analysis. Dr. Tak noted that key findings from the study and analyses of ThermoDox plus RFA suggested that the therapeutic effect of ThermoDox plus RFA may be improved when the RFA dwell time for solitary lesions is greater than or equal to 45 minutes.

Publication of HEAT Study Manuscript. On October 16, 2017, the Company announced publication of the manuscript, "Phase III HEAT Study Adding Lyso-Thermosensitive Liposomal Doxorubicin to Radiofrequency Ablation in Patients with Unresectable Hepatocellular Carcinoma Lesions," in Clinical Cancer Research, a high impact, peer-reviewed medical journal. The article provided detailed learnings from the Company’s 701-patient HEAT Study and included results from computer simulation studies and interesting findings from a post hoc subgroup analysis, all of which – when examined together – suggested a clearer understanding of a key ThermoDox heat-based mechanism of action: the longer the target tissue is heated, the greater the doxorubicin tissue concentration.

Additionally, the article explored the hypothesis prompted by these findings: ThermoDox, when used in combination with RFA standardized to a minimum dwell time of 45 minutes (sRFA ≥ 45 min), may increase the overall survival (OS) of patients with hepatocellular carcinoma (HCC). The final OS analysis demonstrated that in a large, well bounded, subgroup of patients (n=285 patients, 41% of the previous 701 patient HEAT Study), treatment with a combination of ThermoDox and standardized RFA provided an average 58% improvement in OS compared to standardized RFA alone. The Hazard Ratio (HR) was 0.63 (95% CI 0.43 – 0.93) with a p-value of 0.0198. In this large subgroup, median OS for the ThermoDox plus standardized RFA group translated into a 25.4-month (more than 2.1 years) survival benefit over the standardized RFA-only group – totaling approximately 80 months (6-1/2 years, which is considered a curative treatment for HCC) for the ThermoDox plus standardized RFA group versus 53 months for the standardized RFA-only group.

GEN-1 Immunotherapy

Presentation of GEN-1 Clinical Development Program and Recent Clinical and Translation Research Data by Ovarian Cancer Expert at Oppenheimer & Co. Investor Event. On March 5, 2018, the Company announced that Premal H. Thaker, M.D., M.S., a nationally recognized expert in gynecologic oncology, Associate Professor of Obstetrics and Gynecology at the Siteman Cancer Center at the Washington University School of Medicine in St. Louis, and investigator in Celsion’s GEN-1 development program presented, "Ovarian Cancer: New Horizons and Treatments" at an investor event hosted by Oppenheimer & Co. in New York City on March 1, 2018.

Dr. Thaker’s presentation highlighted the following:

GEN-1 is a novel new approach that is designed to deploy the anti-cancer mechanism of the potent, broad-spectrum immunotherapy, IL-12, without the toxicities associated with the recombinant IL-12 protein.

In a Phase I study of GEN-1, 14 newly diagnosed patients with Stage III/IV ovarian cancer were intraperitoneally administered GEN-1 plus neoadjuvant chemotherapy. Results from the study demonstrated immunological changes consistent with the ability of GEN-1 to increase local (peritoneal) levels of IL-12 and its downstream anti-cancer cytokines and reduction in vascular endothelial growth factor (VEGF; potent angiogenic factor that contributes to tumor angiogenesis) levels with little change in systemic circulation.

The study showed no serious systemic toxicities. These clinical findings, including a partial or complete response in 86% of patients, R0 resections in 100% of patients treated at the highest dose cohort and recently reported progression-free survival (PFS) of over 21 months compared to historical controls for PFS of approximately 12 months, support further evaluation of GEN-1’s safety and efficacy in patients with Stage III/IV ovarian cancer.

Filing of Phase I/II Clinical Protocol for Evaluation of GEN-1 Immunotherapy to Treat Newly Diagnosed Ovarian Cancer. On November 13, 2017, the Company announced the submission of its Phase I/II clinical trial protocol to the U.S. Food and Drug Administration for GEN-1, the Company’s DNA-based immunotherapy for the localized treatment of ovarian cancer. The protocol is designed with a single dose escalation to evaluate the safety and biological activity of GEN-1 at 100mg/m² in newly diagnosed Stage III/IV ovarian cancer patients, followed by a continuation at the selected dose in Phase II in a 90-patient 1 to 1 randomized study. The study protocol was unanimously supported by an expert medical advisory board and lead investigators from the Phase IB OVATION Study and is summarized belo

Open label, 1:1 randomized design

Enrollment in up to 90 patients with Stage III/IV ovarian cancer at ten U.S. centers

Primary endpoint of improvement in PFS comparing GEN-1 with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone.

PFS for patients treated per protocol in the recently completed Phase IB OVATION Study continues to be followed. The Company expects to initiate enrollment in the Phase I portion of the OVATION II Study during the second quarter of 2018. The Phase I/II study will be powered to show a 33% improvement in the primary endpoint, PFS, when comparing GEN-1 with neoadjuvant chemotherapy to neoadjuvant chemotherapy alone.

In January 2018, the Company announced that after a two-month review period, the U.S. Food and Drug Administration (FDA) accepted the Company’s submission with minor comments focusing primarily on the role of the Data Safety Monitoring Board and the need for a 3 + 3 evaluation of the single Phase I cohort and full evaluation of the maintenance treatment at the highest dose prior to initiation of the Phase II portion of the trial.

R&D Day. On October 12, 2017, the Company held a Research and Development (R&D) Day in New York City with presentations focused on the Company’s development program using ThermoDox for the treatment of primary liver cancer and GEN-1 for treatment of ovarian cancer. Leading OPTIMA Study clinical investigators representing various geographical regions (Asia-Pacific and Europe) and multiple medical disciplines (hepatology, interventional radiology and surgery) presented their past and current experiences with ThermoDox for the treatment of primary liver cancer. The GEN-1 immunotherapy presentations focused on the Company’s clinical and translational research data from its recently completed Phase IB OVATION Study. The lead clinical investigator for the OVATION Study and leading immuno-oncology experts from the Roswell Park Cancer Institute presented their current experience with GEN-1 immunotherapy for the treatment of ovarian cancer.

Corporate Development

Raised $42.6 Million in Gross Proceeds During 2017, Including $27.5 Million in Gross Proceeds During the Fourth Quarter. Recent minimally dilutive equity offerings totaling approximately $28.8 million in gross proceeds during the fourth quarter of 2017 through January 2018 have strengthened the Company’s balance sheet and will be used to support the Company’s development efforts and potentially significant clinical milestones for ThermoDox and GEN-1 clinical programs into the third quarter of 2019.

The Company raised $17.0 million in gross proceeds through the exercise of outstanding common stock warrants in early October 2017.

In October 2017, the Company completed an underwritten equity offering of shares of common stock and warrants to purchase common stock with Oppenheimer & Co. The gross proceeds of the offering were approximately $6.6 million.

In November 2017, the Company raised $3.9 million in gross proceeds off its ATM Equity Facility with Cantor Fitzgerald.

Financial Results

For the year ended December 31, 2017, Celsion reported a net loss attributable to common shareholders of $20.7 million, or a loss of $2.72 per share, compared to a net loss of $22.1 million, or a loss of $11.89 per share, for the year ended December 31, 2016.

Net cash used for operating activities was $16.6 million for the year ended December 31, 2017, compared to $18.4 million for the year ended December 31, 2016. Cash and cash equivalents at December 31, 2017 were $24.2 million. Total cash provided by financing activities was approximately $36.5 million during 2017 comprising $17.9 million in net proceeds from sales of common stock and $21.1 million in net proceeds from the exercise of common stock warrants in 2017, partially offset by $2.6 million in debt service payments under the Hercules Venture Debt Facility ("Hercules").

Research and development costs were $13.1 million for the year ended December 31, 2017, compared to $14.6 million for the year ended December 31, 2016. Clinical development costs for the Phase III OPTIMA Study were $6.7 million for the year ended December 31, 2017 compared to $5.6 million for the same period of 2016. This increase was due to patient costs and investigator grants associated with higher patient enrollment in the Phase III OPTIMA Study during 2017. R&D costs for other development programs were lower because of the Company’s tighter clinical development focus around the pivotal Phase III OPTIMA Study for the treatment of primary liver cancer and the clinical development program for GEN-1 IL-12 immunotherapy for the localized treatment of ovarian cancer, as well as lower costs in 2017 associated with the production of ThermoDox clinical supplies to support the OPTIMA Study.

General and administrative expenses were $5.9 million for the year ended December 31, 2017, compared to $6.5 million for the year ended December 31, 2016. This decrease was due to lower non-cash stock option compensation expense and reduced professional fees.

For the year ended December 31, 2017, other expenses included a non-cash charge of $2.5 million related to the impairment of certain in process research and development assets related to the development of our glioblastoma multiforme (GBM) cancer product candidate offset by a $1.2 million reduction in the earn-out liability related to potential milestone payments for the GBM product candidate.

During 2017, the Company recognized deemed dividends totaling $0.4 million collectively regarding multiple agreements with certain warrant holders, pursuant to which these warrant holders agreed to exercise, and the Company agreed to reprice, certain warrants. Warrants to purchase 790,410 shares of common stock were repriced at $2.70 and warrants to purchase 506,627 shares of common stock were repriced at $1.65. The Company received $3.0 million in gross proceeds from the sale of these repriced warrants.

Interest expense decreased by $0.6 million for the year ended December 31, 2017 due to lower principal balances outstanding under the Company’s Venture Debt Facility with Hercules. The loan balance and end of term charges on this debt facility were paid in full on June 1, 2017.

Quarterly Conference Call

The Company is hosting a conference call to provide a business update and discuss year-end 2017 financial results at 11:00 a.m. EDT on Tuesday, March 27, 2018. To participate in the call, interested parties may dial 1-888-737-3628 (Toll-Free/North America) or 1-719-325-4879 (International/Toll) and ask for the Celsion Corporation Year-End 2017 Earnings Call (Conference Code: 1256084) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com.

The call will be archived for replay on Tuesday, March 27, 2018 and will remain available until April 10, 2018. The replay can be accessed at 1-719-457-0820 or 1-719-785-5608 using Conference ID: 1256084. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT Tuesday, March 27, 2018.

On March 27, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported Dr. Simon Pedder, Chief Business and Strategy Officer, will present at the 17th Annual Needham Healthcare Conference in New York City on Tuesday, March 27, 2018 at 2:00 pm EDT (Press release, Athenex, MAR 27, 2018, View Source;p=RssLanding&cat=news&id=2339864 [SID1234525007]).

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The presentation will be webcasted, and can be accessed at the Investor Relations section of the Company’s website, located at www.athenex.com. An archive will be available on this website until April 27, 2018.

On March 27, 2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported financial results for the three months and year ended December 31, 2017 and reported on corporate developments (Press release, Aptose Biosciences, MAR 27, 2018, View Source;p=RssLanding&cat=news&id=2340004 [SID1234525006]). Unless specified otherwise, all amounts are in US Dollars.

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The net loss for the quarter ended December 31, 2017 was $3.28 million ($0.12 per share) compared with $2.97 million ($0.23 per share) for the quarter ended December 31, 2016. Total cash and cash equivalents and investments as of December 31, 2017 were $11.4 million, or $13.3 million Canadian dollars, which, based on current operations and estimations, provide the Company with sufficient resources to fund research and development and operations into Q1 2019.

"2017 was a year of tremendous progress for Aptose," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We achieved our strategic goal in bringing CG’806, our oral first-in-class pan-FLT3/pan-BTK inhibitor, from an early preclinical molecule to a stage where we are preparing to file an IND and initiate clinical trials in patients with acute myeloid leukemia (AML) and certain B-cell malignancies later this year. This required considerable scale-up manufacturing and formulation development, as well as pathway suppression analysis, xenograft efficacy, and pharmacokinetic and safety studies. Separately, we successfully completed formal root cause studies for APTO-253, our small molecule c-Myc inhibitor, as well as the manufacture of a new cGMP batch of drug supply sufficient for dosing AML patients in an ongoing Phase Ib trial. We look forward to completing the required stability and other studies with the new clinical supply to submit to the FDA, with the hope of having the CMC-related clinical hold released for a timely re-initiation of patient dosing. At the same time, we and our collaborators continued to perform mechanistic research on ‘806 and ‘253 and have generated data that compel us to advance both compounds clinically."

Corporate Highlights

Orphan drug designation and patent allowance granted for CG’806 – During the year, the USPTO issued a patent that claims numerous compounds including the CG’806 compound, pharmaceutical compositions comprising the CG’806 compound, and methods of treating various diseases. Furthermore, in December the FDA granted orphan drug designation to CG’806 for the treatment of patients with AML. The FDA assigns orphan drug designation to support the development of medicines for underserved patient populations. Orphan drug designation provides Aptose certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.

ASH presentations – In December, Aptose and its collaborators, The University of Texas MD Anderson Cancer Center and the OHSU Knight Cancer Institute, delivered multiple poster presentations and abstracts at the American Society of Hematology (ASH) (Free ASH Whitepaper) 59th Annual Meeting & Exposition. Researchers at MD Anderson elucidated the unique ability of CG’806 to kill a broad range of AML cells by suppressing multiple pathways, to overcome resistance seen with other FLT3 inhibitors, and to act synergistically with other agents. OHSU researchers evaluated the activity of CG’806 on patient primary bone marrow specimens through the Beat AML Initiative. CG’806 exhibited broad and potent single agent activity, and enhanced activity when combined with Bcl-2 or BET inhibitors, against AML and CLL patient samples. In addition, two abstracts on APTO-253, one describing its molecular target leading to suppression of c-MYC gene expression and the other describing its synthetic lethality comparable to olaparib in cells deficient in BRCA1 and BRCA2 function, were published online by ASH (Free ASH Whitepaper). Results demonstrate that, unlike olaparib, APTO-253 does not produce myelosuppression even at the maximum tolerated dose.

Completed manufacture of APTO-253 cGMP clinical supply – Aptose has completed manufacture of the cGMP clinical supply that will be required for the potential return of APTO-253 to the clinic. Stability, sterility, mock infusion, animal bridging and blood compatibility studies are currently underway. Upon successful completion of those studies, Aptose plans to submit findings to the FDA to seek release of the CMC-related clinical hold and allow resumption of patient dosing in the open Phase 1b trial in patients with AML or myelodysplastic syndrome (MDS).

CG’806 pre-IND progress – Aptose successfully manufactured CG‘806 drug substance and formulated drug product, and then performed animal dose range finding preclinical studies of CG’806 in rodents and dogs, and successfully dosed up to 1000 mg/kg/day, the maximum feasible dose, with no observable toxicities noted. Also, Aptose completed manufacturing 2.6kg of a drug batch that will be used for IND-enabling GLP animal toxicity studies.

Global license agreement with OHM Oncology – Earlier this month, Aptose announced an exclusive global license agreement that provides OHM Oncology with the rights for the development, manufacture and commercialization of APL-581, as well as related molecules from Aptose’s dual bromodomain and extra-terminal domain motif (BET) protein and kinase inhibitor program. Aptose will retain reacquisition rights to certain molecules, while OHM will have the rights to develop and sublicense all other molecules.
Financial Results

Effective December 31, 2017, we changed our presentation currency to US dollars from Canadian dollars. All amounts included in this document are in US dollars unless disclosed otherwise. The change in reporting currency was accounted for on a retrospective basis as if the US dollar had always been the Company’s presentation currency. Accordingly, the financial statements for all the periods presented have been translated to the US dollar.

The decrease in the net loss during the year ended December 31, 2017 compared with the year ended December 31, 2016 results mostly from our decision in January 2017 to refocus our resources on our CG’806 development program and towards determining the root cause of the manufacturing issue with the APTO-253 program. Expenses were lower due to the cancellation of the LALS/Moffitt collaboration, lower costs associated with the APTO-253 program, and offset by increased development activities related to the CG’806 development program which were nominal in comparable periods, other than the license fee that was paid in June 2016 to acquire an option on the technology.

Research and Development
Components of research and development expenses

In the 2016 comparative period, we paid $1.0 million to CrystalGenomics, Inc. ("CG") for an option fee related to the CG’806 technology and in that period began research and development activities for this program;
An increase in research and development activities related to our CG’806 development program. Activities in the current year ended December 31, 2017 included formulation studies and PK studies and the manufacturing of a first batch of the drug substance to be used in dose range finding studies, the initiation of the dose range finding studies, and the initiation of the manufacturing of a GLP batch of drug substance to be used in the toxicity studies. CG’806 program expenses were nominal in the comparative period as the technology was licensed to us in June 2016;
Reduced expenditures on the APTO-253 program. In the year ended December 31, 2017, we completed the root cause analysis and determined the cause of the manufacturing issue, established a Corrective and Prevention Action plan to ensure the clinical supply can be manufactured in a reliable manner, and the initiation of manufacturing of a new clinical supply. In the comparative period, we were actively manufacturing a clinical batch and preparing to return APTO-253 to the clinic; and
Savings from cancellation of the LALS/Moffitt collaboration which was active in the year ended December 31, 2016. There are no costs related to this program in the year ended December 31, 2017.
General and Administrative
Components of general and administrative expenses

General and administrative expenses excluding salaries, decreased slightly in the year ended December 31, 2017, compared with the year ended December 31, 2016. The decrease is mostly the result of lower travel costs, consulting and rent costs in the first six months of the fiscal year related to cost containment initiatives taken in the prior fiscal year and offset by higher investor relations, professional fees and travel costs in the three months ended December 31, 2017;
Salary expenses in the year ended December 31, 2017, were slightly lower in comparison with year ended December 31, 2016. Savings from reduced headcount were partially offset by higher bonuses recognized in the current period; and
Stock-based compensation decreased in the year ended December 31, 2017, compared with the year ended December 31, 2016, due to large forfeitures in the three months ended March 31, 2017 and also due to grants in the prior periods having a greater fair value than the grants issued in the year ended December 31, 2017, and therefore contributing to higher stock-based compensation in the year ended December 31, 2016.
FOURTH QUARTER RESULTS OF OPERATIONS

The changes in research and development expenses in the three months ended December 31, 2017 as compared to the three months ended December 31, 2016 result from the following:

An increase in R&D activities on our CG’806 program as described above;
A decrease in R&D activities on our APTO-253 program as described above;
Savings from cancellation of the LALS/Moffitt collaboration as described above; and
Higher salaries expense mostly related to additional clinical research staff hired at the end of the year to prepare for returning APTO-253 to the clinic.

higher investor relations, professional fees and travel costs in the three months ended December 31, 2017;
higher salaries related mostly to a bonus adjustment in the comparative period; and
stock option grants issued in the current year with a lower grant date fair value than the comparative period.
Conference Call and Webcast

Aptose will host a conference call today, Tuesday, March 27, 2017 at 5:00 p.m. EDT to discuss results for the three months and year ended December 31, 2017. Participants can access the conference call by dialing (844) 882-7834 (North American toll-free number) and (574) 990-9707 (International) and using conference ID # 8873259. The conference call can be accessed here and will also be available through a link on the Investor Relations section of Aptose’s website at ir.aptose.com. An archived version of the webcast along with a transcript will be available on the Company’s website for 30 days. An audio replay of the webcast will be available approximately two hours after the conclusion of the call through April 3, 2018 by dialing (855) 859-2056, using the conference ID # 8873259.

Athenex has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Athenex, 2018, MAR 26, 2018, View Source [SID1234527576]).

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RXi Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, RXi Pharmaceuticals, 2018, MAR 26, 2018, View Source [SID1234525021]).

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