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EyePoint Pharmaceuticals Announces Preliminary Fourth Quarter and Full-Year 2019 Revenues

On January 23, 2020 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a biopharmaceutical company committed to developing and commercializing innovative ophthalmic products reported preliminary, unaudited, total and net product revenue for the fourth quarter and full-year 2019. For the fourth quarter ended December 31, 2019, total revenues are estimated to be between $7.5 and $8.2 million and net product revenues are estimated to be between $6.9 and $7.6 million, a significant acceleration from net product revenues of $1.0 million reported for the third quarter ended September 30, 2019 (Press release, pSivida, JAN 23, 2020, View Source [SID1234553462]). For the full-year 2019, total revenues are estimated to be between $19.3 and $20.0 million and net product revenues are estimated to be between $15.8 and $16.5 million. The net product revenues acceleration in the fourth quarter of 2019 was driven by strong customer demand for both DEXYCU and YUTIQ.

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"2019 was a year marked by significant achievement as evidenced by two successful commercial product launches, DEXYCU and YUTIQ," said Nancy Lurker, President & Chief Executive Officer of EyePoint. "We are very pleased by the sales acceleration in the fourth quarter for both products which positions the Company well for a strong 2020. Customer demand is building, physician acceptance continues to grow, and we will continue to execute on additional agreements with payors to expand access to our products. In parallel, we remain focused on advancing and enhancing our pipeline for areas of unmet need in ocular disease. "

Customer demand, represented as units purchased by physicians and ambulatory surgical centers (ASCs) from the Company’s distributors, showed continued strong unit growth for both products with estimated increases of 43% and 86% for YUTIQ and DEXYCU, respectively, in the fourth quarter of 2019 versus the third quarter of 2019. This growth was supported by the permanent and specific J-Code for YUTIQ in place as of October 1, 2019 and the execution of key agreements with payors and large ASCs during the period.

The difference between reported GAAP net product revenues and customer demand is due to the timing of distributor purchases from the Company based upon customer demand and distributor inventory levels from quarter to quarter. The Company also moved from a single distributor title model to a more traditional multi-distributor structure during the fourth quarter.

Net product revenue for YUTIQ is estimated to be between $4.1 and $4.5 million and between $11.4 and $11.8 million for the fourth quarter and full-year ended December 31, 2019, respectively.

Net product revenue for DEXYCU is estimated to be between $2.8 and $3.1 million and between $4.4 and $4.7 million for the fourth quarter and full-year ended December 31, 2019, respectively.

The Company estimates that it had cash and cash equivalents of approximately $22 million at December 31, 2019.

The preliminary fourth quarter and full-year 2019 revenue results included in this release were calculated prior to the completion of a review by the Company’s independent registered public accounting firm and are therefore subject to adjustment.

Fourth Quarter and Full Year 2019 Financial Results Conference Call

Eyepoint Pharmaceuticals will host a conference call and webcast to discuss fourth quarter and full-year 2019 financial results on Thursday, March 5, 2020 at 8:30 AM ET. To access the conference call, please dial (877) 312-7507 from the U.S. and Canada or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 7314529. A live webcast will be available on the Investor Relations section of the corporate website at View Source A replay of the webcast will also be available on the corporate website.

Kura Oncology Announces Transition of Chief Medical Officer

On January 23, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that Antonio Gualberto, M.D., Ph.D., will step down as Head of Development and Chief Medical Officer to pursue other opportunities (Press release, Kura Oncology, JAN 23, 2020, View Source [SID1234553461]). Bridget Martell, M.A., M.D., currently Vice President of Clinical Development at Kura, has been named acting Chief Medical Officer while the company completes an executive search. Dr. Gualberto plans to serve in an advisory capacity during the transition, which will take effect on February 7, 2020.

"Antonio has been a key contributor to the tipifarnib development program over the past five years," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "He is responsible for much of the underlying translational work that identified the biomarkers of activity, including the discovery of the CXCL12 pathway as a target of tipifarnib, which enabled us to achieve clinical proof of concept in multiple solid tumor and hematologic indications and provided the framework for our ongoing registrational strategies. We thank him for his many contributions to the company and wish him continued success in his future endeavors.

"Now, as we continue our pre-commercial efforts and prepare for the company’s next phase of growth," Dr. Wilson continued, "we are very fortunate to have someone of Bridget’s caliber ready to step up and lead the clinical development organization. Bridget is a proven leader with broad expertise in drug development and a track record of success. Importantly, she has deep familiarity across our pipeline, having served as program lead for KO-539, our emerging menin-MLL inhibitor, for the past two years. I look forward to working even more closely with her in the months ahead as we seek to build on the potential opportunities for tipifarnib and maximize the value of our emerging pipeline."

Dr. Martell began working with Kura as a consultant in November 2017 and joined the company as Vice President of Clinical Development in June 2018, bringing more than 18 years of experience in clinical development, regulatory and medical affairs. She has served in leadership roles of increasing responsibility at Pfizer and Juniper Pharmaceuticals, where she contributed to the development and approval of a number of products, including the renal adjuvant indication for the oncology drug Sutent. Dr. Martell earned her B.S. in microbiology from Cornell University, her M.A. in molecular immunology from Boston University and her M.D. from the Chicago Medical School. She completed her internship and residency in Internal Medicine and was an Internal Medicine chief resident and RWJ Faculty Clinical Scholar at Yale University. She is board certified in both internal and addiction medicine.

FDA Grants Fast Track Designation to Gene Therapy Combination in EGFR-Mutant NSCLC

On January 23, 2020 Genprex reported the FDA has granted a Fast Track Designation to the immune-gene therapy Oncoprex in combination with the EGFR inhibitor osimertinib (Tagrisso) for the treatment of patients with EGFR-mutant non–small cell lung cancer (NSCLC) who have progressed after treatment with osimertinib alone (Press release, Genprex, JAN 23, 2020, View Source [SID1234553460]).

A clinical phase I/II trial will be initiated to evaluate Oncoprex plus osimertinib by Genprex. In addition, the company will initial a phase I clinical trial to evaluate the agent in combination with a checkpoint inhibitor.

"Genprex is excited to receive this important FDA designation," Rodney Varner, chairman and CEO of Genprex, said in a statement. "In addition to potentially facilitating and expediting our pathway to approval, we believe that this FDA designation validates our plan to commercialize Oncoprex immune-gene therapy in combination with EGFR inhibitors for the treatment of lung cancer."

Over 50 patients have been treated with the immune-gene therapy in phase I and phase II clinical trials through Genprex. According to the press release, the company believes the findings from these trials have been encouraging in terms of both safety and efficacy. The agent is made up of Tumor Suppressor Candidate 2 (TUSC2) gene complexed with a lipid nanoparticle. TUSC2 is an active agent in the immune-gene therapy.

"We hope that Fast Track Designation helps us bring our gene therapy to patients more rapidly and that our unique gene therapy platform is more widely recognized for its potential in cancer treatment," Varner said.

Lung cancer is the leading cause of cancer death worldwide, with more than 2 million new cases and 1.7 million deaths per year across the globe. Over 228,000 new cases of lung cancer occur in the United States annually, and 142,000 deaths are related to lung cancer each year. Approximately 84% of all cases of lung cancer are NSCLC, with a 5-year survival rate for metastatic lung cancer of less than 5%.

The FDA’s Fast Track Designation is granted to drugs demonstrating the ability to fulfill unmet medical needs for serious and life-threatening diseases. Should the combination of Oncoprex and the EGFR inhibitor receive approval, it will address the unmet need of patients with EGFR-mutant NSCLC who progress on osimertinib alone

Genprex, Inc. Prices $8,000,000 Common Stock Offering Priced At-The-Market

On January 23, 2020 Genprex, Inc.("Genprex" or the "Company") (NASDAQ: GNPX), a clinical stage gene therapy company developing a new and potentially life-saving approach to treating some of the world’s most deadly cancers based upon a novel proprietary technology platform, reported it has entered into securities purchase agreements with institutional investors for the purchase and sale of 7,620,000 shares of common stock, par value $0.001 per share at an offering price of $1.05 per share, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules (Press release, Genprex, JAN 23, 2020, View Source [SID1234553459]). There are no warrants in the offering. The gross proceeds of the offering will be approximately $8,000,000 before deducting fees and other estimated offering expenses. The Company intends to use the net proceeds to advance its lead clinical programs in non-small cell lung cancer (NSCLC) and for working capital and general corporate purposes. The closing of the registered direct offering is expected to take place on or about January 27, 2020, subject to the satisfaction of customary closing conditions.

A.G.P./Alliance Global Partners is acting as lead placement agent for the offering.

Joseph Gunnar & Co., LLC is acting as co-placement agent for the offering.This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-233774) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by Genprex with the SEC. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, New York 10022 or by email at [email protected]. Joseph Gunnar & Co. LLC, 30 Broad Street, 11th Floor, New York, New York 10004 or by email at [email protected].

iOnctura raises EUR 15 million in Series A financing to progress its pipeline into clinical development

On January 23, 2020 iOnctura B.V., a clinical stage biopharmaceutical company, developing a pipeline of next generation molecules targeting cancer and fibrosis, reported the closing of a EUR 15 million Series A financing (Press release, iOnctura, JAN 23, 2020, View Source [SID1234553458]). The financing was led by INKEF Capital and co-led by VI Partners with participation by new investor Schroder Adveq. iOnctura’s founding investor, M Ventures, also participated in the fundraise. iOnctura was founded in 2017 as a spin-out from Merck, with Merck and Cancer Research UK providing a best-in-class pipeline of molecules that harness both direct and immune-mediated anti-cancer activities in solid cancers and cancer fibrosis.

iOnctura will use the proceeds of the Series A to move its lead molecule IOA-244, a highly selective PI3Kδ-inhibitor, into a Phase I trial in solid tumours and its second program, IOA-289, an ATX-inhibitor, through IND enabling studies. The superior properties of IOA-244 are expected to enable iOnctura to be the first company to clinically demonstrate that highly selective PI3Kδ inhibition not only drives an immune-mediated response but also a direct anti-tumoural effect in a stratified patient population across multiple solid tumour indications.

The board of directors of iOnctura BV welcomes Fiona MacLaughlin, of INKEF Capital and Diego Braguglia of VI Partners.

Catherine Pickering, Chief Executive Officer of iOnctura, commented: "iOnctura has made significant progress with its two lead molecules which are being developed as next generation dual immune and tumour targeting therapies. We are very excited to move our first molecule into human clinical testing and accelerate our second molecule towards clinical trials.

We welcome new investors INKEF Capital, VI Partners and Schroder Adveq to iOnctura and with the continued support from our founding investor M Ventures, we look forward to taking iOnctura into the next stage of development."

Fiona MacLaughlin, Director of INKEF Capital, said: "INKEF’s strategy is to support talented management teams developing novel treatments that address high unmet medical needs via novel scientific insights and understanding. The highly experienced executive management team led by Catherine at iOnctura have a solid track record in drug development and commercialisation. Together with the scientific contribution of its world class scientific advisory board and its research partner Cancer Research UK, iOnctura has consolidated a scientific understanding we consider to be a true and valuable differentiator."

Hakan Goker, Chairman of iOnctura board and Executive Investment Director, M Ventures, added: "We helped found iOnctura to deliver clinical validation of emerging new biology around direct and immune mediated effects of key targets in cancer and fibrosis. The differentiated and targeted clinical approach iOnctura is using offers significant potential to treat patients with life-threatening diseases. We are excited to provide continued support to iOnctura as it advances its pipeline into the clinic."

iOnctura’s most advanced program, IOA-244, is a clinical phase, next generation PI3Kδ inhibitor with a unique chemical structure, exquisite selectivity, excellent drug-like properties and an expected best-inclass safety profile. Its second program, IOA-289, is a novel autotaxin (ATX) inhibitor with superior potency compared to clinical-stage ATX inhibitors. IOA-289 is being developed as a first-in-class therapy for solid tumour indications that over express ATX and are burdened with cancer-associated fibrosis. IOA-289 has demonstrated anti-tumour and anti-fibrotic efficacy in preclinical models and is in advanced in vivo safety studies.