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]).

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"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.

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]).

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"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.

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]).

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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.

On March 21, 2019 Exscientia, a world-leading Artificial Intelligence (AI)-driven drug discovery company, reported that it has entered a three-year AI drug discovery partnership with leading biopharma company Celgene, including an initial $25 million upfront payment and eligibility to receive substantial milestones based on the clinical, regulatory and commercial success of the program (Press release, Exscientia, MAR 21, 2019, View Source [SID1234553912]). In addition, Exscientia is due to receive tiered royalties on net sales on any product resulting from the collaboration. Exscientia will apply its full-stack AI drug discovery capabilities to the execution of the entire project – from gene to the drug candidate.

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The collaboration will use AI to accelerate the discovery of small molecule therapeutic drug candidates for three therapeutic programmes for Celgene in the areas of oncology and autoimmunity.

Exscientia will use its cutting-edge Centaur Chemist AI drug discovery platform, which has demonstrated its unparalleled capabilities on multiple projects and its ability to reduce the timelines by at least three-quarters to discover pre-clinical drug candidates. Applying AI to improve the speed of delivery of new treatments for patients is a key goal of this collaboration.

This deal extends Exscientia’s list of partnerships with blue chip pharma and biotech companies, with existing collaborations involving Roche, GSK, Sanofi and Evotec, cementing Exscientia’s reputation as the partner of choice in the rapidly developing field of AI-driven drug discovery. At the start of this year, the Oxford based Exscientia secured a $26 million Series B investment to expand its capabilities, develop its platform and build its proprietary drug pipeline.

Professor Andrew Hopkins, CEO of Exscientia, commented: "We’re incredibly proud to collaborate with Celgene and to sign another partnership with a key industry player, reinforcing our place at the forefront of AI drug discovery. Today, patients can wait more than ten years from initial drug discovery to its availability as a treatment. With autoimmune diseases and cancer rates increasing, the pharmaceutical industry’s R&D productivity needs to dramatically improve – and technology is a key part of this. Since our pioneering Nature papers in the field, we have been developing our AI platform on the principle that AI combined with human creativity can significantly accelerate the drug discovery process and thus drastically improve access of new drugs to the market. We’re excited to work with Celgene to drive this transformational change in new therapeutic areas."

On March 21, 2019 Samsung Bioepis Co., Ltd. reported findings of a three-year follow-up study comparing biosimilar ONTRUZANT (trastuzumab) and reference medicine trastuzumab in early or locally advanced HER2-positive breast cancer (Press release, Samsung Bioepis, MAR 21, 2019, View Source [SID1234534530]). The data, which show comparable overall survival and cardiac safety, were presented today at the 16th St. Gallen International Breast Cancer Conference 2019 taking place in Vienna, Austria.

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"With the development of our biosimilar trastuzumab, we aimed to make one of the mainstays of modern cancer therapy more accessible for more people more quickly, and these long-term data underline the importance of that aim," said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. "We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges."

Participants enrolled in an initial Phase III study received eight cycles of the biosimilar trastuzumab or the reference medicine concurrently with chemotherapy in the neoadjuvant setting. Following surgery, they received additional 10 cycles of the biosimilar trastuzumab or the reference medicine. After completion of therapy, 367 of these participants (186 in the biosimilar trastuzumab group and 181 in the reference medicine group) were enrolled in the follow-up study. Median follow-up from initiation of study treatment was 40.8 months in the biosimilar trastuzumab group and 40.5 months in the reference medicine group.

Overall survival was 97% in the biosimilar trastuzumab group and 93.6% in the reference medicine group (HR 0.39, 95% CI, 0.14-1.12). Event-free survival was 92.5% in the biosimilar trastuzumab group and 86.3% in the reference medicine group (HR 0.49, 95% CI, 0.26-0.91). The incidence of cardiac events was rare for both treatment groups throughout the three-year follow-up period. There were three cases of asymptomatic significant left ventricular ejection fraction (LVEF) decrease (biosimilar trastuzumab, n=1; reference medicine, n=2), with all patients recovering with LVEF ≥ 50%. There were no cases of symptomatic congestive heart failure, cardiac death or other significant cardiac conditions reported in either group.

The poster of this study will be exhibited at the 16th St. Gallen International Breast Cancer Conference 2019, as follows:

[P156] 3-YEAR FOLLOW-UP OF A PHASE III STUDY COMPARING SB3 (TRASTUZUMB BIOSIMILAR) AND REFERENCE TRASTUZUMAB IN HER2 POSITIVE EARLY OR LOCALLY ADVANCED BREAST CANCER IN NEOADJUVANT SETTING [POSTER SESSION I, MARCH 21, 2019]
ONTRUZANT (trastuzumab) 150 mg was granted the European Commission (EC) Marketing Authorization in November 2017 and was approved by the U.S. Food and Drug Administration in January 2019. In February 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a 420 mg vial presentation of ONTRUZANT.iii With the adoption of CHMP’s positive opinion for ONTRUZANT 420 mg vial presentation, ONTRUZANT will be available in two vial sizes in Europe, providing clinics with greater convenience and flexibility than the 150 mg vial presentation alone.