On December 13, 2018 ESSA Pharma Inc. ("ESSA" or the "Company") (TSX-V: EPI,NASDAQ: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal fourth quarter and year ended September 30, 2018 (Press release, ESSA, DEC 13, 2018, View Source [SID1234532082]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"We have narrowed our selection of an IND candidate to a small number of compounds with high potency, metabolic stability and, therefore, predicted long half-lives, as well as superior pharmaceutical properties," stated David Parkinson, MD, President and CEO of ESSA. "We will make a final IND candidate selection following full compound selectivity characterization and in vivo animal model results, which are expected in the first calendar quarter of 2019. We look forward to preparing our lead candidate efficiently in order to enter the clinic as expeditiously as possible after our IND submission."

2018 Year Highlights

Achieved significant progress in advancing the Company’s next-generation aniten program toward identifying a lead clinical product candidate and submitting an Investigational New Drug Application to the U.S. Food and Drug Administration
Lead compounds are at least fifteen times more potent and five times more stable in vitro compared to the first-generation aniten N-terminal domain inhibitor compound, EPI-506.
Two poster abstracts accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Symposium (ASCO-GU) in February 2019, which will be the first public presentation of preclinical data from ESSA’s new aniten compounds.
Closed equity financings totaling $26 million in January 2018, issuing a total of 4,321,000 common shares and 2,189,000 prepaid warrants exercisable at a nominal price of $0.002.
Strengthened the Company’s preclinical development capabilities.
Summary Financial Results
Effective April 25, 2018, the Company consolidated its issued and outstanding common shares on the basis of one post-consolidation share for every 20 pre-consolidation shares. The consolidation applied uniformly to all ESSA common shares, incentive stock options, prepaid warrants, and other securities convertible into or exercisable for common shares. Unless otherwise stated, all ESSA common share and per share amounts have been restated retrospectively to reflect this share consolidation.

Net Income (Loss). ESSA recorded a net loss of $11.6 million ($2.55 loss per common share based on 4,566,519 weighted average common shares outstanding) for the year ended September 30, 2018, compared to a net loss of $4.5 million ($3.09 loss per common share based on 1,454,936 weighted average common shares outstanding) for the year ended September 30, 2017, which included a gain on derivative liability of $7.3 million. The net loss for the fourth quarter ended September 30, 2018 was $2.3 million compared to a net loss of $1.9 million for the fourth quarter ended September 30, 2017.
Research and Development ("R&D") expenditures. R&D expenditures for the year ended September 30, 2018 were $4.9 million net of grants ($5.1 million gross) compared to $5.7 million net of grants ($10.9 million gross) for the year ended September 30, 2017. For the fourth quarter ended September 30, 2018, R&D expenditures were $0.9 million net of grants ($1.2 million gross), as compared to $1.2 million (net and gross) for the fourth quarter ended September 30, 2017. The decreases in R&D expenditures for the full year and fourth quarter were primarily related to decreases in manufacturing and clinical trial costs as ESSA focused its R&D resources on preclinical research related to the Company’s next-generation aniten compounds in the current year. ESSA concluded its Phase I clinical study of EPI-506 in September 2017.
General and administration ("G&A") expenditures. G&A expenditures for the year ended September 30, 2018 were $5.9 million compared to $5.1 million for the year ended September 30, 2017. For the fourth quarter ended September 30, 2018, G&A expenditures were $1.2 million, compared to $1.1 million for the fourth quarter ended September 30, 2017. The increases in the full year and fourth quarter primarily reflected increased corporate activity, such as the 1:20 share consolidation, filing of the base shelf prospectus, as well as compensation expenses and increased share-based payments reflecting the vesting of stock options.
Liquidity and Outstanding Share Capital
Cash on hand at September 30, 2018, was $14.8 million, with working capital of $12.3 million, reflecting the aggregate gross proceeds of the completed January 2018 financing, which totaled $26 million.

As of September 30, 2018, the Company had 5,776,098 common shares issued and outstanding, and 2,189,000 common shares issuable on the exercise of prepaid warrants at a nominal exercise price of $0.002 per common share. If all prepaid warrants are exercised, there would be approximately 7,965,098 ESSA common shares outstanding.

In addition, there were 474,937 common shares issuable upon the exercise of warrants and broker warrants at a weighted-average exercise price of $34.35 per ESSA common share and 888,709 ESSA common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.81 per common share.

On December 13, 2018 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in large-scale PCR-based DNA manufacturing, reported selected preliminary unaudited financial results for the full fiscal year and quarter ended September 30, 2018 (Press release, Applied DNA Sciences, DEC 13, 2018, View Source [SID1234532062]).

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Preliminary (Unaudited) Fiscal 2018 Financial Results:

Revenues for fiscal 2018 totaled $3.9 million, a decrease of 18% from $4.8 million from the same period in the prior fiscal year. The decrease in revenues was attributable to a decrease in revenues of approximately $2.2 million in the textile industry for protecting cotton and synthetic supply chains. This decrease was offset by an increase in revenue from Contract Manufacturing of DNA for diagnostics as well as an increase from development projects, primarily those associated with partners’ pre-commercial business initiatives in legal cannabis and pharmaceuticals.
Deferred revenue increased to $1.9 million as of September 30, 2018 as compared to $352 thousand at September 30, 2017. The reason for this increase is due to the initial cotton order of $1.2 million shipped during June 2018 having extended payment terms and to be recognized to revenue as the payments become due. The extended payment terms for this shipment are three equal installments due 90, 180 and 270 days from shipment. One-third of the revenue was recognized during the fiscal fourth quarter of 2018. The increase in deferred revenue is also attributable to fees received for a variety of contracts that include specific milestones and therefore were not able to be fully recognized as revenue during the quarter ended September 30, 2018.
Operating expenses for the fiscal year ended September 30, 2018 decreased by $2.2 million or 13% as compared to the prior fiscal year. The decrease is primarily attributable to a decrease in stock-based compensation of approximately $1.9 million and bad debt expense of $403 thousand.
Net loss for the fiscal year ended September 30, 2018 decreased to $11.7 million or $0.40 per share, compared with a net loss of $12.9 million or $0.49 per share for the fiscal year ended September 30, 2017.
Preliminary (Unaudited) Fiscal Fourth Quarter Results:

Revenues increased 4% for the fourth quarter of fiscal 2018 to $1.2 million, compared to $1.1 million reported in the fourth quarter of fiscal 2017, and increased 18% as compared to revenues for the fiscal third quarter ended June 30, 2018 of $1.0 million. The year-over-year increase in revenues is primarily attributable to an increase in revenues from development and pre-commercial pilots in pharmaceuticals and cannabis. This increase was offset by a decrease in textile revenues.
Total operating expenses were $4.4 million, compared with $3.7 million in the prior year’s quarter, an increase of approximately 19%. The increase in year-over-year total operating expenses is attributable to an increase in stock-based compensation expense due to the timing of the annual employee grant, payroll and research and development expenses, offset by a decrease in depreciation and amortization expense.
Net loss for the quarter ended September 30, 2018 was $3.5 million, or $0.12 per share, compared with a net loss of $2.9 million, or $0.10 per share for the same period in the prior fiscal year and a net loss of $2.9 million, or $0.10 per share for the third fiscal quarter ended June 30, 2018.
The Company also announced that it anticipates filing its Annual Report on Form 10-K for the fiscal year ended September 30, 2018 with the Securities and Exchange Commission during the week of December 17, 2018, and will hold an investor call during the week of December 24, 2018.

"Our performance in fiscal 2018 reflects execution on pre-commercial sales and business development initiatives to sow new revenue streams by leveraging our proven DNA taggant technology platform and capitalizing on secular industry trends emphasizing supply chain security, sustainability and traceability all along the value chain," stated Dr. James A. Hayward, president and CEO of Applied DNA. "During the year we continued to expand our business beyond cotton with diverse partners using synthetic fibers and generating initial revenues from the legal cannabis and pharmaceutical markets while progressing other programs, such as leather traceability, towards commercialization while also implementing feasibility pilots with a diverse customer base.

"Notable advancements made during the year included: in textiles, we furthered adoption of our platform for the tagging of non-cotton synthetic textiles to complement our cotton business that itself has begun to expand internationally; in the nascent legal cannabis industry where compliance with governmental permitting requirements is fundamental to its future, our partnership with TheraCann has yielded a seed-to-sale tracking program powered by blockchain and molecular tagging technologies and the development of a tagging system specifically designed to meet the needs of commercial growers; in pharmaceuticals, we advanced the manufacturing scale-up of our on-dose solution for enhanced patient safety and supply chain security with partner Colorcon; in biotherapeutics, we formally launched our LineaRx subsidiary that has already expanded our opportunity-set to include the potentially high-reward therapeutics space. We also saw continued demand for development pilots that serve as an indicator of growing industry interest in our technology platform and its value proposition."

Concluded Dr. Hayward, "Building on these advancements, we anticipate revenue from our key business verticals in fiscal 2019 with opportunities for increased contributions from certain verticals, such as in textiles where we are progressing towards big-box and online retailer adoption of DNA-tagged synthetic fiber products manufactured by ecosystem partners. In pharmaceuticals, we are pursuing regulatory approval of our molecular tag that if realized during 2019 should generate a second revenue milestone from Colorcon and make our solution compelling for pharmaceutical manufacturers in an era of government-mandated serialization practices."

Preliminary Results
The financial data contained in this press release are unaudited, preliminary, based upon Applied DNA’s good faith estimates and subject to completion of Applied DNA’s financial closing procedures. While Applied DNA expects that its final financial results for the fiscal year and quarter ended September 30, 2018, following the completion of its financial closing procedures, will generally be consistent with the amounts provided in this press release, Applied DNA’s actual results may differ materially from these estimates as a result of the completion of its financial closing procedures, as well as final adjustments and other developments that may arise between now and the time that its financial results for the fiscal year and quarter ended September 30, 2018 are finalized.

The results provided in this press release are preliminary and subject to completion and audit of Applied DNA’s financial statements in conjunction with the Company’s 2018 Form 10-K filing with the Securities and Exchange Commission anticipated to occur during the week of December 17, 2018.

On December 13, 2018 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq:YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Dr. Claus Møller, MD, Ph.D., Chief Executive Officer of Y-mAbs Therapeutics will provide an overview and update on the company’s business at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Y-mAbs Therapeutics, DEC 13, 2018, View Source [SID1234532065]). The presentation will take place on Thursday, January 10, 2019, at 8:00 AM Pacific Standard Time.

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On December 12, 2018 Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS) reported highlights from a Key Opinion Leader (KOL) breakfast featuring a presentation by Brian Druker, M.D., Professor of Medicine at the School of Medicine at Oregon Health & Science University (OHSU), Director of OHSU’s Knight Cancer Institute, and Aptose management team (Press release, Aptose Biosciences, DEC 12, 2018, View Source [SID1234532023]).

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The webcast of the presentation will be archived on Aptose’s website here.

William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, first provided a recap on CG-806, Aptose’s highly potent pan-FLT3/pan-BTK inhibitor, and included the following key highlights:

CG-806 has a well-differentiated mechanism of action, selectively and potently inhibiting kinase clusters that include all forms of FLT3 and BTK, as well as rescue pathways that can allow resistance to other drugs, and avoiding other kinase clusters associated with toxicity
CG-806 demonstrated superior potency on acute myeloid leukemia (AML) patient cells relative to all other FLT3 inhibitors
CG-806 demonstrated superior potency on B-cell patient cells relative to ibrutinib
In preclinical mouse model studies, CG-806 induced rapid and sustained tumor eradication with no observed toxicity
CG-806’s safety profile remains clean: New results, recently presented at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting from 28-day GLP toxicity and toxicokinetic studies, continue to demonstrate a highly favorable safety profile with no adverse findings to date
Dr. Druker discussed the evolution of kinase inhibitors as anticancer drugs, reviewed the current treatment landscape in AML and B-cell cancers, emphasizing the medical needs for these patient populations, and highlighted his experience with CG-806 alone and in combination to potentially address these medical needs. Key highlights:

CG-806 potently killed primary malignant cells from patients with diverse hematologic malignancies
CG-806 demonstrated superior killing potency on cells from AML patients compared to five other FLT3 inhibitors
AML patient cells with the FLT3-ITD mutation, found in approximately 30% of AML patients, were highly sensitive to CG-806
Just presented at ASH (Free ASH Whitepaper), AML patient cells with the IDH-1 mutation were unexpectedly sensitive to CG-806, a new finding that further broadens CG-806’s potential use and potential paths for rapid development
CG-806 data demonstrated broad and superior killing potency compared to ibrutinib, which is the current standard of care for B-cell malignancies, on cells from patients with CLL and other B-cell cancers
Drug combination studies with CG-806 and venetoclax on patient bone marrow cells suggest the combination may become the preferred drug combination for patients with AML, CLL, ALL and other hematologic malignancies
"CG-806 is unlike any molecule we have investigated, and it is more than just a FLT3 and BTK inhibitor," said Dr. Druker. "806 has the unusual ability to suppress key driver and rescue pathways and overcome the resistance that develops with other kinase inhibitors, and it has demonstrated potent activity against actual primary cells from patients with hematologic malignancies. We are hopeful that clinical testing will prove it to be a new treatment for a patient population in need of new options."

Stephen B. Howell, M.D., Professor of Medicine at the University of California, San Diego, and Associate Director for Clinical Research at the Moores UCSD Cancer Center, who serves as Aptose’s Acting Chief Medical Officer, wrapped up the prepared remarks of the session with current development plans for CG-806:

IND-enabling GLP toxicology and safety studies with CG-806 are complete
As a result of its robust safety profile, Aptose plans to file an IND in the first quarter of 2019 to begin clinical testing of CG-806 both in healthy volunteers (HVS) and in patients with B-cell malignancies
After a therapeutic dose is identified from the HVS or B-cell malignancy clinical trials, Aptose intends to expand into acutely ill AML patients and other sensitive subpopulations
About CG-806
CG-806 is a preclinical stage oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors. It is in development for acute myeloid leukemia (AML) and B cell lymphoma.

Brian J. Druker, M.D.
Brian Druker, M.D., is the director of the Knight Cancer Institute, Associate Dean for oncology of the OHSU School of Medicine, JELD-WEN Chair of Leukemia Research and a Howard Hughes Medical Institute investigator. He revolutionized the treatment of cancer through research that resulted in the development of imatinib, the first drug to target the molecular defect of a cancer while leaving healthy cells unharmed. Marketed under the name Gleevec, his discovery turned a once-fatal cancer, chronic myeloid leukemia, into a manageable condition. This work changed the life expectancy of patients with CML from an average of 3 to 5 years to a 95% five-year survival, and has resulted in a paradigm-shift in cancer treatment from non-specific chemotherapy to highly targeted therapeutic agents. He is a member of the National Academy of Medicine, the National Academy of Sciences and, among numerous awards, is the recipient of the 2009 Lasker-DeBakey Clinical Medical Research Award and most recently, the 2018 Tang Prize in Biopharmaceutical Science.

Dr. Druker currently serves as the Chair of the Scientific Advisory Board for Aptose. He receives compensation from Aptose for this role. He and his team at OHSU, through the BEAT AML collaboration, have directly conducted studies with CG-806 on fresh bone marrow samples from patients with various hematologic malignancies, and data from these studies serve as the cornerstone of presentations made by Aptose Biosciences.

On December 12, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that the first patient was treated in a phase 1 dose escalation study combining pelareorep and carfilzomib with Bristol-Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab) to treat relapsed multiple myeloma patients (Press release, Oncolytics Biotech, DEC 12, 2018, View Source [SID1234532025]). This study is based on findings from the NCI 9603 multiple myeloma study that combined pelareorep with carfilzomib that resulted in objective responses, elimination of multiple myeloma cells and most importantly, an inflamed phenotype with PD-L1 overexpression.

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"Having worked with pelareorep in multiple myeloma and understanding its ability to act as a potentiator of checkpoint blockade, I’m very excited to work with the Oncolytics team on this study," said Dr. Craig Hofmeister, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine. "Pelareorep has proven its ability to create an inflamed phenotype and its potential for upregulation of PD-1 on tumor-infiltrating lymphocytes. My hope is this study leads not only to an effective combination dosing schedule but provides quantitative data describing the expression of PD-1, along with correlative studies that reveal the roles of both immune-mediated and direct cytotoxic myeloma cell killing."

This open-label, phase 1 study, conducted by Dr. Hofmeister at Emory University, will enroll up to 62 patients to examine the side effects and best dosing schedule of pelareorep when given in combination with dexamethasone, carfilzomib, and nivolumab in treating participants with relapsed multiple myeloma. The primary objectives of the study are to determine the maximum tolerated dose of pelareorep in combination with carfilzomib and nivolumab. Secondary outcome measures include time to progression, progression-free survival and overall survival, as well as the characterization of an inflamed phenotype and confirmation of biomarker responses indicative of tumor inflammation.

"We now have our second checkpoint inhibitor combination study enrolling, and I’m excited for the potential of the immune and biomarker data to come from it," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "These studies, along with our soon to be initiated studies combining pelareorep with Merck’s Keytruda, also in multiple myeloma, and Roche’s Tecentriq in neoadjuvant breast cancer, will provide further evidence that pelareorep has the potential to expand the use of checkpoint inhibitors by priming tumors cells. The confirmation of our predictive biomarkers enhances the likelihood of success in registrational studies, thereby reducing both clinical and commercial risk making pelareorep more attractive to potential partners."

For more information about the study, including a comprehensive list of inclusion and exclusion criteria, please visit: www.clinicaltrials.gov (identifier: NCT03605719).

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.