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Leap Therapeutics Presents TRX518 Data at ESMO Immuno-Oncology Congress 2018
and Updated Data from DKN-01 Study in Biliary Tract Cancer

On December 14, 2018 Leap Therapeutics, Inc. (NASDAQ:LPTX) reported that its clinical data from its ongoing Phase I/II study of TRX518 in combination with gemcitabine, KeytrudaÒ (pembrolizumab), or OpdivoÒ (nivolumab) in patients with advanced solid tumors at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2018 (Press release, Leap Therapeutics, DEC 14, 2018, View Source [SID1234532057]). In addition, Leap provided the top-line final data from the Phase I/II study of DKN-01 in combination with gemcitabine and cisplatin chemotherapy in patients with advanced biliary tract cancer.

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Leap will host a conference call and webcast on Monday, December 17, 2018 at 8:30 AM US Eastern Time with Jason J. Luke, MD, Assistant Professor of Medicine, Pritzker School of Medicine at the University of Chicago and Todd M. Bauer, MD, Sarah Cannon Research Institute/Tennessee Oncology PLLC, TN. Drs. Luke and Bauer will discuss patient outcomes and provide additional perspectives about the TRX518 program.

TRX518

TRX518 is unique among Glucocorticoid-Induced TNF Receptor (GITR) agonist antibodies for its aglycosyl design, permitting activation of GITR signaling without depleting CD8+ T-effector cells. In cancer patients, TRX518 has been shown to increase CD8+ T-effector cell infiltrate and the expression of granzyme B, as well as decrease CD4+ T-regulatory cell infiltrate. The dual function of TRX518 is designed to enhance the anti-tumor activity of chemotherapies and immune checkpoint inhibitors, such as anti-PD-1/PD-L1 antibodies.

TRX518 Clinical Data Presented at ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2018

The clinical trial is a continuation of the TRX518 multi-dose monotherapy study that has been expanded with three combination study arms to evaluate lower (2 mg/kg loading dose with 1 mg/kg maintenance doses) and higher (4 mg/kg loading dose with 1 mg/kg maintenance doses) dose levels of TRX518 in combination with gemcitabine chemotherapy or Keytruda or Opdivo anti-PD-1 immune checkpoint antibodies.

Key Findings:

· In monotherapy and combination studies, TRX518 demonstrated safety, tolerability, and clinical benefit in patients with heavily pretreated solid tumors.

· TRX518 in combination with Keytruda or Opdivo achieved durable complete and partial responses in patients not expected to respond to anti-PD-1 therapy alone, including a confirmed complete response in an esophageal squamous cell cancer patient and a confirmed partial response in an anti-PD-1 refractory urothelial cancer patient.

· TRX518 in combination with gemcitabine achieved meaningful clinical benefit and objective tumor reduction for heavily pretreated patients suffering from pancreatic, biliary tract, mesothelioma, appendiceal, and ovarian cancer.

· The biopsies of responding patients demonstrated an increase in CD8+ T-effector cells and granzyme B expression and a reduction in CD4+ T-regulatory cells and FoxP3 expression, hallmarks of immune activation and anti-tumor activity associated with GITR agonism.

TRX518/gemcitabine combination:

The combination arm evaluating TRX518 in combination with gemcitabine enrolled thirty patients who had received one to nine prior therapies. Four patients were treated at the lower dose of TRX518, and twenty-six patients were treated at the higher dose. The study enrolled fourteen patients with pancreatic cancer, five with biliary tract cancer, and eleven with other cancers including ovarian, appendiceal, and mesothelioma. Seventeen patients had previously progressed on gemcitabine therapy, and ten had previously progressed on anti-PD-1/PD-L1 therapy.

Clinical outcomes data as of December 5, 2018 includes:

TRX518 + gemcitabine

Response
Evaluable

Stable
Disease

Progressive
Disease

Disease
Control Rate
(Response
Evaluable)

Overall

Lower dose TRX518

Higher dose TRX518

56.5

Pancreatic Cancer

Biliary Tract Cancer (BTC)

Other Cancers

Nineteen pancreatic or biliary tract cancer (PBC) patients were enrolled, and nine remain on study. Nearly all of these patients had received prior gemcitabine therapy, and nine (47%) remained on study for more than four cycles. Eight (67%) of twelve evaluable PBC patients previously treated with gemcitabine who received the higher dose of TRX518 have had stable disease, including a fourth-line pancreatic cancer patient who remains on study in Cycle 9 with a 21% reduction in tumor burden. Pancreatic cancer patients who have progressed on gemcitabine have extremely poor outcomes with studies indicating a range of 1.6 to 2.9 months between median progression and median overall survival.

Additional reductions in tumor burden and durable clinical benefit have been noted in appendiceal cancer (-4% in Cycle 7), mesothelioma (-5% in Cycle 6), and two in ovarian cancer (-15% in Cycle 5, -9% off after 4 cycles).

TRX518/Keytruda or Opdivo combination

The combination arms evaluating TRX518 in combination with Keytruda or Opdivo enrolled fourteen patients in the dose escalation cohorts as of December 5, 2018. Both patients treated with the higher dose of TRX518 plus Keytruda have had clinical benefit. An esophageal squamous cell carcinoma patient has had a confirmed complete response, which remains ongoing for seven months, and an ocular melanoma patient has had a 23% reduction in tumor volume and six months of ongoing stable disease. In the low dose TRX518 plus Opdivo combination arm, a patient with urothelial carcinoma who had failed prior Keytruda had a confirmed partial response and remained on therapy for six months.

Enrollment is now complete in the dose escalation cohort for TRX518 and Keytruda and continues in the high dose escalation cohort of TRX518 and Opdivo. Leap anticipates that dose expansion cohorts for both combinations will initiate in the first quarter 2019.

DKN-01

DKN-01 is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric cancer, hepatobiliary cancer, and gynecologic cancers.

At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, Leap announced that the combination of DKN-01 and paclitaxel generated a 46.7% overall response rate, 19.6 weeks median progression free survival, and 61.1 weeks median overall survival in fifteen evaluable esophagogastric cancer patients as a second-line therapy. In the subgroup of twelve evaluable patients with heavily pre-treated esophageal squamous cell carcinoma, DKN-01 and paclitaxel produced a 33.3% overall response rate, 13.7 weeks median progression free survival, and 31.0 weeks median overall survival.

At the ESMO (Free ESMO Whitepaper) 2018 Annual Meeting, Leap announced that the combination of DKN-01 and Keytruda demonstrated promising clinical activity with a 23.5% overall response rate and 58.8% disease control rate in evaluable gastric or gastroesophageal junction cancer patients who have been heavily pretreated and have not had prior anti-PD-1/PD-L1 therapy. The combination has generated durable responses in subgroups less likely to respond to pembrolizumab monotherapy, for example, patients whose tumors are microsatellite stable and/or PD-L1 negative. Additional data from the DKN-01/Keytruda combination is expected in the second quarter of 2019.

DKN-01 in combination with gemcitabine and cisplatin in Advanced Biliary Tract Cancer

The open-label, Phase I/II study enrolled fifty-one patients with advanced biliary tract cancer (BTC). Seven patients received one of two dose levels (150 mg or 300 mg) of DKN-01 in combination with gemcitabine and cisplatin during Part A, with forty-four additional patients treated at the 300 mg dose level of DKN-01 in the Part B expansion cohort. Forty-two patients were chemotherapy treatment-naïve, and nine patients had received 1-2 prior therapies. The primary objective of this study was to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin.

In the study, DKN-01 in combination with gemcitabine and cisplatin was well tolerated with no new emerging safety trends. Forty-seven patients overall were treated at the 300 mg DKN-01 dose level, and their median overall survival was 53.7 weeks (12.4 months). Median progression free survival was 37.7 weeks (8.7 months). Ten patients (21.3%) had a partial response and thirty-one patients (66.0%) experienced a best response of stable disease, representing a disease control rate of 87.2%. Two patients (4.3%) had progressive disease, and four patients (8.5%) were non-evaluable for response. The one-year probability of overall survival was 0.51, and the six-month probability of progression free survival was 0.58. The median number of cycles of DKN-01 was seven (range of 1 to 23), and the median duration on study was 331 days.

"Patients with metastatic biliary tract cancer have a poor prognosis with an unmet medical need, with median overall survival of less than one year. We are very pleased by the progression-free survival, overall survival, and favorable safety profile demonstrated by DKN-01 in combination with gemcitabine and cisplatin in this single arm study," commented by Andrew X. Zhu, M.D., Director of Liver Cancer Research at Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School. "The activity of DKN-01 in biliary tract cancer warrants further development in the front-line setting as well as in second-line in combination with anti-PD-1/PD-L1 antibodies."

TRX518 Clinical Perspectives Conference Call and Webcast

On Monday, December 17, 2018 at 8:30AM ET, Leap will be hosting a conference call and webcast for the investment community. To access the conference call, please dial (866) 589-0108 (US/Canada Toll-Free) or (409) 231-2048 (international) and refer to conference ID 9187987. The presentation will also be webcast live and will be available on Leap’s website, View Source A replay of the webcast will be available on Leap’s website after the event and will be available for a limited time.

IMV Inc. Presents Updated Positive Data From Phase 1b/2 Combination Clinical Trial in Advanced Ovarian Cancer at 2018 ESMO Immuno-Oncology Congress

On December 13, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported that investigators shared new positive data from the company’s ongoing DeCidE1 (DPX-Survivac with low dose CyclophosphamIDe and Epacadostat) clinical trial at the 2018 ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress (Press release, IMV, DEC 13, 2018, View Source [SID1234534100]). The phase 1b/2 study is evaluating the safety and efficacy of the combination of IMV’s lead candidate DPX-Survivac, low dose cyclophosphamide, and 100 mg or 300mg of Incyte’s IDO1 enzyme inhibitor epacadostat in patients with advanced recurrent ovarian cancer.

In a poster presentation, Oliver Dorigo, M.D., Ph.D., Associate Professor of Obstetrics and Gynecology (Oncology), Stanford University Medical Center, who served as the trial’s lead investigator and author on the poster, shared topline safety results from 53 enrolled patients and efficacy data from the 32 participants evaluable for immune-related and clinical responses, as well as blood sample and tumor biopsy analyses.

Key findings include:

Evidence of a clinical marker based on Baseline Tumor Burden (BTB), a measure of tumor size predictive of patient response to DPX-Survivac

37.5% (12/32) of evaluable study subjects began treatment with a non-bulky disease defined as BTB < 5 cm.

73% (8/11) of tumor regressions and 80% of clinical responses (4/5) observed in subset of patients with BTB < 5 cm.

Responders showing prolonged duration of clinical benefits reaching up to more than two years, surpassing the progression-free interval from their previous chemotherapy treatment

Robust systemic survivin-specific T cell responses and evidence of survivin-specific T cells tumor infiltration correlated with clinical benefits

100% of durable clinical responses correlated with T cell infiltration

Epacadostat triggered inhibition of the conversion of tryptophan into kynurenine that was dose dependent

Cohort demographics were balanced and the combination yielded a tolerable safety profile

"This data set provided meaningful information on how the potential benefits of DPX-Survivac may best be translated to patients, including the connection between tumor regressions and T cell infiltration in the tumor microenvironment," said Frederic Ors, Chief Executive Officer at IMV. "We believe that DPX-Survivac is the first targeted T cell therapy to induce significant tumor regressions in challenging tumors such as those seen in ovarian cancer. We remain committed to developing DPX-Survivac for patients with significant unmet medical needs, and look forward to our upcoming discussions with regulatory authorities in the USA, Canada and Europe."

Updated Clinical Response and Safety Data for DeCidE1

At the time of data cut-off, 53 patients were enrolled in the phase 1b clinical trial, including 14 from the 100mg epacadostat dosing cohort and 39 from 300mg epacadostat cohort. Based on 300 mg cohort results, IMV and Incyte agreed to stop dosing patients with epacadostat before completion of the study. Patients who completed at least one CT scan, as required per the trial protocol, were evaluable for response analysis.

71% of patients were evaluable for responses in the 100mg cohort and 56% in the 300mg dose cohort. At time of data cut-off, 8 participants remained on treatment and were being evaluated for clinical responses.

(1) Partial Response (PR) is defined as ≥30% decrease in sum of target lesions
(2) Stable Disease (SD) is defined as Â 30% decrease and ≤ 20% increase in sum of target tumor lesions
(3) Disease Control Rate (DCR) refers to the total number of patients achieving complete response, partial response, and stable disease.

"Recurrent ovarian cancer treatment remains a significant unmet need and represents a challenge for immunotherapy," said Gabriela Nicola Rosu, M.D., Chief Medical Officer at IMV Inc. "What we have showed here is that the dynamic interaction between the survivin specific T cells induced by DPX-Survivac and the tumor size and its growth kinetics can be a determinant of clinical responses. We

believe that this information is significant for the future development of DPX-Survivac and may indicate a pathway to more efficacious immunotherapeutic treatments for patients."

Poster Session Details

Session Title: Poster Display Session
Location: Foyer, Geneva Palexpo
Poster ID: 87P; Abstract ID 262
Abstract Title: "New clinical data from the DeCidE1 trial: Results on DPX-Survivac, low dose cyclophosphamide (CPA), and epacadostat (INCB024360) in subjects with advanced recurrent epithelial ovarian cancer"
Date: December 14 – 15, 2018
Time: 12:30 p.m. – 13:00 p.m. (local time)
Presenter: Dr. Oliver Dorigo, DeCidE1 Clinical Investigator and Lead Author
Investor Call Information

IMV will host a webcast and conference call on Thursday, December 13 at 8:30 a.m. ET to provide an overview of its ESMO (Free ESMO Whitepaper)-IO presentation.

Dial-in: (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (International)

Conference ID#: 6192578

A live audio webcast and presentation will be available via this link, or by pasting this URL in an internet browser: View Source

About the DeCidE1 Phase 1b/2 Trial

The phase 1b/2 trial is an open label, uncontrolled, safety and efficacy study for individuals with advanced, platinum-sensitive and resistant ovarian cancer. The phase 1b portion has two dosing cohorts:

100mg of epacadostat twice daily (BID), with DPX-Survivac and low dose cyclophosphamide, and

300mg of epacadostat BID in combination with DPX-Survivac and low dose cyclophosphamide.

The primary endpoints are to determine:

The safety profile of the combination regimen,

Induction of systemic survivin specific T cells in the blood, and

Induction of T cell infiltration into tumors.

Secondary endpoints include objective response rate (ORR) using modified RECIST v1.1 criteria; duration of response based on modified RECIST criteria; time to progression (TTP); and overall survival (OS.)

IMV conducted the phase 1b/2 study in collaboration with Incyte Corporation. IMV recently announced that, based on the 300 mg cohort results, IMV and Incyte have agreed to stop dosing patients in this trial with epacadostat. IMV is continuing the phase 2 portion of the trial as a monotherapy study evaluating DPX-Survivac in the advanced and recurrent ovarian cancer subpopulation with BTB < 5 cm.

IMV intends to report updated results from the phase 1b when data from at least 16 evaluable participants in the second dosing cohort are available. Investigators plan to submit final results for publication in a peer-reviewed journal.

About Ovarian Cancer

According to the American Cancer Society (ACS), ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Often diagnosed in its advanced stages, about 21,290 women received a new diagnosis of ovarian cancer in 2015; approximately 14,180 women would die from the disease, according to ACS estimates.

Ovarian cancer has a significant impact globally as well. The World Cancer Research Fund reports that ovarian cancer is the seventh most common cancer in women worldwide (18 most common cancer overall), with 239,000 new cases diagnosed in 2012.

ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Fourth Quarter and Year Ended September 30, 2018

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.

"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.

Y-mAbs Therapeutics To Present At 37th Annual J.P. Morgan Healthcare Conference

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.

Applied DNA Announces Selected Preliminary Unaudited Fiscal 2018 Year End and Fourth Quarter Financial Results

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]).

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.