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IntelGenx Reports Fourth Quarter and Full-Year 2018 Financial Results

On March 22, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the fourth quarter and twelve-month periods ended December 31, 2018 (Press release, IntelGenx, MAR 22, 2019, View Source [SID1234534569]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2018 Fourth Quarter Financial Summary:

Revenue was $650,000, compared to $1.5 million in the 2017 fourth quarter
Adjusted EBITDA was ($2.0 million), compared to ($600,000) in Q4-2017
Cash and short-term investments totaled $11.0 million as at December 31, 2018
2018 Full-Year Financial Summary:

Revenue was $1.8 million, compared to $5.2 million in 2017
Net comprehensive loss was $10.7 million, compared to net comprehensive loss of $2.7 million in 2017
Adjusted EBITDA was ($7.9 million), compared to ($1.4 million) in 2017
Recent Operational Highlights:

Announced U.S. Food and Drug Administration ("FDA") acceptance of the RIZAPORT New Drug Application ("NDA") resubmission and the Agency’s assignment of a Prescription Drug User Fee Act ("PDUFA") goal date of April 1, 2019
Partnered with Gensco Pharma to market RIZAPORT in the United States
Announced FDA pre-approval inspection of IntelGenx’s facility related to the RIZAPORT NDA
Granted Japanese patent for RIZAPORT VersaFilm
Began Montelukast VersaFilm dosing in patients with mild to moderate Alzheimer’s Disease in Phase 2a study
Announced Montreal’s Douglas Mental Health University Institute as ninth Montelukast VersaFilm Phase 2a clinical trial site
"The agreements we secured with Tilray and Gensco Pharma in 2018 represented an important inflection point for IntelGenx as we advanced our strategy to commercialize our pipeline of innovative oral film products with strong partners," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We have a very positive outlook for 2019 and 2020 and look forward to updating our stakeholders as we make progress towards achieving a number of key development and commercialization milestones."

Financial Results:

Total revenues for the three-month period ended December 31, 2018 amounted to $650,000, a decrease of $850,000 compared to $1.5 million for the three-month period ended December 31, 2017. The change is mainly attributable to a decrease in deferred revenues partially offset by an increase in R&D revenues. Operating costs and expenses were $2.9 million for the fourth quarter 2018, versus $2.3 million for the corresponding three-month period of 2017. For Q4-2018, the Company had an operating loss of $2.2 million, compared to operating income of $850,000 for the comparable period of 2017.

Total revenues for the twelve-month period ended December 31, 2018 amounted to $1.8 million, compared to $5.2 million for the twelve-month period ended December 31, 2017. Operating costs and expenses were $10.8 million for the full year 2018, versus $7.7 million for the corresponding 12-month period of 2017. For the twelve-month period of 2018, the Company had an operating loss of $9.0 million, compared to an operating loss of $2.5 million for the comparable period of 2017. Net comprehensive loss was $10.7 million, or $0.14 per basic and diluted share, for the twelve-month period of 2018, compared to net comprehensive loss of $2.7 million, or $0.04 per basic and diluted share, for the comparable period of 2017.

As at December 31, 2018, the Company’s cash and short-term investments totalled $11.0 million, compared with $4.9 million as at December 31, 2017.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2018 as well as the 2019 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, Friday, March 22, 2019.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2018 fourth quarter and full year financial results on Monday, March 25, 2019, at 8:00 a.m. EDT. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 1297963. The call will be also be webcast live and archived at www.intelgenx.com.

SBP Provides Business Update and Files Annual Report for 2018

On March 22, 2019 Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, reported financial results for the year ended December 31, 2018 (Press release, Sun BioPharma, MAR 22, 2019, View Source [SID1234534568]).

Front-Line Combination PDA Study

The Company’s clinical team, working in conjunction with its medical advisors and physician investigators, have been enrolling patients in the second cohort in its study, "SBP-101 Administered in Combination with Gemcitabine and Nab-paclitaxel in Newly Diagnosed Patients with Metastatic Pancreatic Ductal Adenocarcinoma." The study includes a dose-escalation phase with sequential cohorts of patients receiving treatment at each of three dose levels. The dose-escalation phase is to be followed by an expansion phase at the optimal dose level. Contract research organizations have been engaged to assist in managing the study at one site in the United States (Courante Oncology), the University of Florida where SBP-101 was invented, and at three sites in Australia (Novotech).

Dr. Suzanne Gagnon, Chief Medical Officer remarked, "We appreciate the enthusiastic commitment of our current investigators and are now in the process of evaluating additional investigational sites for the expansion phase of the study, which we hope to commence later this year. Expanding in both the US and Australia will allow more patients to have access to SBP-101 while receiving gemcitabine and nab-paclitaxel."

Company Names Founder and Executive Chairman as Chief Executive Officer

Effective October 31, 2018, Michael T. Cullen, MD, MBA, the company’s Executive Chairman, has accepted the additional responsibilities of President and CEO of Sun BioPharma, Inc. and its wholly owned subsidiary, Sun BioPharma Australia Pty Ltd.

"Pleased with our progress, and encouraged by the success of our amazing team, I am honored to resume leadership of this exciting project as we seek to improve the prognosis of patients with life-threatening pancreatic disease," stated Dr. Cullen.

Private Placement of Convertible Promissory Notes

On December 21, 2018, the Company entered into Securities Purchase Agreements for the purchase of convertible promissory notes ("2018 Notes") and warrants to purchase common stock in the Company with a number of accredited purchasers. Additional agreements were entered into on December 31, 2018 and several dates in January of 2019. Pursuant to these closings under the Securities Purchase Agreements we issued 2018 Notes with a principal balance of $2.2 million and we also issued warrants to purchase up to an aggregate of 1,243,510 additional shares, resulting in gross proceeds of $1.3 million received by the Company in December 2018 and $0.9 received in January of 2019.

"We are most grateful for the loyal support of long-term shareholders, and the confidence exhibited by new investors in our work," noted Dr. Cullen.

Financial Results for the Three Months and Full Year Ended December 31, 2018

General and administrative (G&A) expenses decreased 71.9% to $329,000 in the fourth quarter of 2018, compared with $1.2 million in the fourth quarter of 2017. G&A expenses decreased 38.4% to $2.1 million in 2018, down from $3.4 million in 2017. The decrease in the fourth quarter was caused primarily by reduced stock-based compensation expense, reduced salary expense due to staff reductions and by costs incurred in 2017 that were not incurred in 2018 in connection with efforts to complete a public offering in the fourth quarter of 2017. The decrease for the full year of 2018 is primarily the result of a decrease in stock-based compensation, fewer staff members in the year and voluntary salary reductions taken at the end of 2018.

Research and development (R&D) expenses decreased 51.7% to $308,000 in the fourth quarter of 2018 down from $638,000 in the fourth quarter of 2017. R&D expenses for the full year of 2017 decreased 31.2% to $1.8 million as compared with $2.6 million for 2017. The decrease in fourth quarter resulted from decreased staff costs associated with fewer staff and voluntary salary reductions taken in the 4th quarter of 2018 as well as decreased clinical trial and related costs for our Phase 1a clinical trial. The full year decrease in R&D expenses resulted from a decrease in salary expense versus the prior year due to lower staff levels and less spending on clinical studies as the spending on the 2018 clinical trial did not begin until mid-2018.

Other expense, net, was $286,000 in the current quarter compared to $428,000 in the fourth quarter of 2017. Other expense, net, decreased to $2.3 million for the full year 2018, down from $4.9 million in the prior year. The decrease in the current quarter was primarily due to decreased interest expense resulting from the amortization of the discount on the 2017 convertible notes payable which converted to equity in May of 2018. For the full year the decrease was due primarily to charges recorded in 2017 related to the induced conversion of debt. The debt which converted in 2018 was not induced and therefore no loss on the conversion was recorded.

Net loss for the quarters ended December 31, 2018 and 2017 was $0.8 million and $2.2 million, or $0.16 and $0.58 per diluted share, respectively. The net loss for the full year 2018 was $5.9 million, or $1.27 per diluted share, compared to a net loss of $10.4 million, or $2.91 per diluted share, for 2017.

Balance Sheet and Cash Flow

Total cash resources were $1.4 million as of December 31, 2018, compared to $152,000 as of December 31, 2017. Total current assets were $1.8 million and $767,000 as of December 31, 2018, and December 31, 2017, respectively. These increases resulted primarily from the proceeds raised from the sale of equity securities in the first half of the year totaling $2.3 million and the sale of convertible promissory notes in December of 2018 offset in part by the Company’s use of cash to fund operations in the current year.

Current liabilities decreased to $1.6 million as of December 31, 2018, compared to $4.2 million as of December 31, 2017. The decrease in current liabilities resulted primarily from the conversion in May of 2018 of approximately $3.3 million of previously outstanding debt and accrued interest into 750,742 shares of our common stock and warrants to purchase 646,279 shares of common stock partially offset by the accreted carrying value of the convertible promissory notes sold during December of 2018.

Net cash used in operating activities was $2.4 million for the year ended December 31, 2018, compared to $3.4 million for the year ended December 31, 2017. The net cash used in each of these periods primarily reflects the net loss for these periods and was partially offset by stock-based compensation expense and amortization of debt discount as well as by the effects of changes in operating assets and liabilities. In the year ended December 31, 2017, the net loss is also offset by non-cash charges recorded for the loss on induced debt conversion.

About SBP-101

SBP-101 is a first-in-class, proprietary, polyamine compound designed to exert therapeutic effects in a mechanism specific to the pancreas. Sun BioPharma originally licensed SBP-101 from the University of Florida Research Foundation in 2011. The molecule has been shown to be highly effective in preclinical studies of human pancreatic cancer models, demonstrating superior activity to existing FDA-approved chemotherapy agents. Combination therapy potential has also been shown for pancreatic cancer. SBP-101 differs from current pancreatic cancer therapies in that it specifically targets the exocrine pancreas and has shown efficacy against primary and metastatic disease in animal models of human pancreatic cancer. Therefore, management believes that SBP-101 may effectively treat both primary and metastatic pancreatic cancer, while leaving the insulin-producing islet cells and non-pancreatic tissue unharmed. The safety and metabolic profile demonstrated in our first-in-human safety study further supports evaluation of the potential for additive or synergistic effects in combination with current standard pancreatic cancer treatment.

Y-mAbs Announces 2018 Financial Results and Corporate Development Highlights

On March 22, 2019 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 financial results for 2018 (Press release, Y-mAbs Therapeutics, MAR 22, 2019, View Source [SID1234534567]).

"We are very pleased to report our first full year financials after Y-mAbs’ successful IPO in September, which we believe has put us in a strong financial position to continue the important work on our two lead pediatric compounds, naxitamab and omburtamab. We plan to file BLAs for both of these compounds by the end of 2019." stated Thomas Gad, Founder, President and Head of Business Development and Strategy.

Dr. Moller, Chief Executive Officer continued, "We believe we have made solid clinical progress with naxitamab and omburtamab during 2018. In 2019, we have much to do and also many catalysts that have the potential to solidify us as a leader in pediatric oncology and as a company focused on rapidly developing therapies to extend and enhance the lives of those living with rare pediatrics cancers."

Financial Year 2018 and Corporate Development Highlights

·On December 13, 2018, Y-mAbs announced the appointment of Dr. Gérard Ber, PhD to its board of directors, and the planned departure of Dr. Michael Buschle, PhD. Dr. Ber most recently served as Chief Operating Officer of Advanced Accelerator Applications SA, which he co-founded in 2002. Dr. Ber brings over 30 years of experience in molecular nuclear medicines, including development, production and commercialization of diagnostics and therapeutic products for several indications in oncology, cardiology, neurology and infectious/inflammatory diseases.

·On December 10, 2018, Y-mAbs announced FDA clearance of the IND for the Company’s humanized bispecific GD2 antibody. The IND was submitted by Memorial Sloan Kettering Cancer Center, who has licensed the antibody to Y-mAbs. A Phase 1/2 clinical trial has been initiated for patients with relapsed/refractory neuroblastoma, high grade osteosarcoma and other GD2(+) solid tumors, where patients have relapsed or refractory disease that is resistant to standard therapy. Y-mAbs expects that this bispecific GD2 antibody may have potential advantages over other bispecific antibodies, such as improved potency due to bivalency, binding to neonatal Fc receptor and longer serum half-life, which obviates continuous infusion and enables more convenient administration to the patient.

·On November 1, 2018, Y-mAbs announced that that Dr. Jeong A Park from the Department of Pediatrics of Memorial Sloan-Kettering Cancer Center would present preclinical data from the Company’s bispecific GD2 antibody at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Bispecific GD2 antibodies were tested in solid tumors in preclinical models with T-cells and were shown to exert anti-tumor effect against GD2(+) tumor xenografts or PDX tumors. Further, the bispecific GD2 antibodies induced rapid and quantitative T-cell homing to tumors, mediating antibody dependent T-cell mediated cytotoxicity (ADTC) against GD2, and were shown to infiltrate tumors with little to no immune response, also known as cold tumors.

·On October 23, 2018, Y-mAbs announced that the Committee for Orphan Medicinal Products of the European Medicines Agency recommended the granting of orphan medicinal product designation in the European Union for naxitamab for the treatment of relapsed or refractory high-risk neuroblastoma. Further, the positive opinion for orphan medicinal product designation had been sent to the European Commission, which subsequently granted the orphan drug designation.

·On September 25, 2018, Y-mAbs announced the closing of its initial public offering of 6,900,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase 900,000 additional shares of common stock, at a public offering price of $16.00 per share. The gross proceeds to Y-mAbs, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, were approximately $110.4 million. All of the shares of common stock were offered by the Company, and Y-mAbs’ common stock is listed on The Nasdaq Global Select Market.

·On August 21, 2018, Y-mAbs announced that it had received Breakthrough Therapy designation for naxitamab, in combination with GM-CSF, for the treatment of high risk neuroblastoma refractory to initial therapy or with incomplete response to salvage therapy in patients older than 12 months of age with persistent, refractory disease limited to bone marrow with or without evidence of concurrent bone involvement.

· On July 10, 2018, Y-mAbs announced that it had entered into an exclusive sublicense with MabVax Therapeutics for its patented neuroblastoma vaccine, which is a bi-valent ganglioside based vaccine intended to treat neuroblastoma. The neuroblastoma vaccine was originally developed by Memorial Sloan Kettering Cancer Center and licensed to MabVax as part of a portfolio of anti-cancer vaccines. MabVax was granted Orphan Drug Designation for the vaccine. Under the terms of the sublicense, the Company has agreed to pay MabVax up to $1.3 million, consisting of an upfront payment of $700,000, and an additional payment of $600,000 on the first anniversary of the sublicense.

·On April 16, 2018, Y-mAbs announced positive Phase I data from treatment with omburtamab in Desmoplastic Small Round Cell Tumor (DSRCT), which is a rare sarcoma of adolescents and young adults. The phase I study of radioiodinated omburtamab was conducted at Memorial Sloan Kettering Cancer Center evaluate toxicity, pharmacokinetics, biodistribution and efficacy. A total of 41 DSRCT patients were treated with escalated doses of intraperitoneal omburtamab as radioimmunotherapy, and the compound had a satisfactory safety profile and appeared to have activity against micro-metastatic DSRCT.

Financial Results

Y-mAbs reported a net loss of $43.3 million, or $1.50 per basic and diluted share, for the financial year 2018 compared to a net loss of $19.2 million, or $0.99 per basic and diluted share for 2017.

Cost and Operating Expenses

Research and development

Research and development expenses were $34.3 million for the year ended December 31, 2018, compared to $14.3 million for 2017, an increase of $20.0 million. The increase in research and development expenses primarily reflects the following:

·$7.5 million increase in outsourced manufacturing for our lead product candidates, naxitamab and omburtamab

·$4.6 million increase in outsourced research and supplies to support expanding development activities

·$2.8 million increase in clinical trial costs due to an increasing number of ongoing clinical trials

·$3.2 million increase in personnel costs

·$0.6 million increase in milestone payments

General and administration

General and administrative expenses were $9.0 million for the year ended December 31, 2018, compared to $4.9 million for the same period of 2017, an increase of $4.1 million. The increase in general and administrative expenses primarily reflects the following:

· $1.8 million increase in personnel costs

·$0.7 million increase in fees for auditors, legal advice and other consultancy services

·$0.4 million increase in leasehold expenses

Cash and Cash Equivalents

The Company had approximately $147.8 million in cash and cash equivalents as of December 31, 2018 compared to $90.5 million as of December 31, 2017. The increase is primarily driven by the $99.8 million net proceeds from the Company’s initial public offering, which is partly offset by the use of cash to fund the Company’s ongoing operations during 2018.

Gossamer Bio Announces 2018 Annual Financial Results

On March 22, 2019 Gossamer Bio, Inc. (Nasdaq:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the year ended December 31, 2018 and provided an update on recent corporate developments (Press release, Gossamer Bio, MAR 22, 2019, View Source [SID1234534560]).

"Since the launch of Gossamer just over a year ago, we have built a robust and balanced pipeline of product candidates, including three clinical-stage assets and multiple preclinical programs, all with potential to meet high unmet medical needs across multiple disease areas," said Sheila Gujrathi, M.D., Gossamer’s Co-Founder and Chief Executive Officer. "With the recent successful completion of our initial public offering, we added to our already strong cash position, extending our runway and providing additional resources to rapidly advance our product candidates. I am extremely proud of all that the Gossamer team has accomplished to date. Our objective is to leverage our deep experience in immunology to enhance and extend the lives of patients with inflammatory and immune-related diseases, including cancer, and I look forward to sharing our progress as we work to bring forth important new medicines to patients."

Recent Highlights

Commenced Phase 2b trial for GB001. In October 2018, Gossamer commenced a Phase 2b trial of the company’s lead candidate, GB001, an oral antagonist of prostaglandin D2 receptor 2 (DP2), in patients with moderate-to-severe eosinophilic asthma. Gossamer expects to conduct an interim analysis for this trial in the first half of 2020 and to announce topline data from the trial in the second half of 2020.

Completed initial public offering (IPO). In February 2019, Gossamer closed its IPO of 19,837,500 shares of its common stock at a price to the public of $16.00 per share. Gossamer raised aggregate gross proceeds of $317.4 million from the offering, prior to deducting underwriting discounts and other offering expenses.

Full-Year 2018 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2018 were $228.7 million. Subsequent to year end, Gossamer raised approximately $295.2 million in its IPO, net of underwriting discounts.
Research and Development (R&D) Expenses: For the year ended December 31, 2018, R&D expenses were $55.3 million, which included $6.0 million of costs related to personnel and external consultants.
In-Process Research and Development (IPR&D) Expenses: For the year ended December 31, 2018, IPR&D expenses were $49.7 million, which was primarily attributable to approximately $27.5 million of costs related to up-front in-licensing and product acquisition payments related to GB004 and GB1275, and $19.1 million of costs associated with the issuance of stock in connection with the acquisition of GB001.
General and Administrative (G&A) Expenses: For the year ended December 31, 2018, G&A expenses were $44.1 million, which was primarily attributable to $30.3 million in stock-based compensation costs, $6.0 million in personnel-related costs, $3.7 million in professional fees, $1.3 million in legal fees and $0.8 million in facility-related costs.
Net Loss: For the year ended December 31, 2018, net loss was $147.0 million, or a loss of $22.59 per share.

Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer

On March 22, 2019 Novocure (NASDAQ: NVCR) reported that it has initiated INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer (Press release, NovoCure, MAR 22, 2019, View Source [SID1234534559]). INNOVATE-3 is Novocure’s fourth phase 3 pivotal trial initiated to study solid tumors beyond glioblastoma.

"Ovarian cancer is one of the most aggressive forms of cancer," said Professor Ignace Vergote, Chairman of the Department of Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven, European Union. "Most ovarian cancer patients are diagnosed at an advanced stage, which makes the disease difficult to treat. Current treatment options are not enough for these patients. We are pleased to begin this trial that has the potential to improve survival in recurrent ovarian cancer."

INNOVATE-3, a prospective, open-label study, will include 540 patients with recurrent, platinum-resistant ovarian cancer. Patients will be randomized to receive either weekly paclitaxel alone or weekly paclitaxel in combination with Tumor Treating Fields tuned to 200 kHz until progression. The primary endpoint is overall survival. Secondary endpoints include progression free survival, objective response rate, severity and frequency of adverse events, time to undisputable deterioration in health-related quality of life or death, and quality of life. Patients may have had a maximum of two prior lines of systemic therapy following diagnosis of platinum-resistance.

Novocure developed the trial design for INNOVATE-3 after learning the results of its phase 2 pilot trial of Tumor Treating Fields in combination with weekly paclitaxel, the INNOVATE trial. In 31 evaluable patients, the INNOVATE trial suggested a more than doubling of progression free survival and an improvement in overall survival among patients who received Optune with paclitaxel compared to paclitaxel alone.

"INNOVATE-3 is Novocure’s fourth phase 3 pivotal trial beyond glioblastoma, demonstrating our commitment to developing Tumor Treating Fields for a variety of solid tumors," said Asaf Danziger, Novocure’s Chief Executive Officer. "At Novocure, we strive to extend survival in some of the most aggressive forms of cancer. Ovarian cancer has been an important area of focus for our research because of the great unmet need faced by these patients. We are now working closely with trial sites and institutional review boards to open sites and enroll patients as quickly as possible."

About Ovarian Cancer `

In the United States, ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old. The incidence of ovarian cancer is approximately 22,500 new cases annually in the United States, approximately 68,000 new cases annually in Europe, and approximately 10,000 new cases annually in Japan. Tumor Treating Fields is not approved for the treatment of ovarian cancer by the U.S. Food and Drug Administration. The safety and effectiveness of Tumor Treating Fields for ovarian cancer has not been established.