On March 18, 2019 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported financial results for the fourth quarter and year ended December 31, 2018 (Press release, Lpath, MAR 18, 2019, View Source [SID1234534460]).

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Highlights
•Fourth quarter ESS revenue contributed 64% of continuing product sales and increased 46%
•ESS revenue for the full year 2018 of $23.4 million increased 42% compared to 2017
•Sale of the Surgical product line completed on December 17, 2018
•New credit facility with Solar Capital completed March 15, 2019

Todd Newton, CEO of Apollo, said, "With the sale of the Surgical product line in December, moving forward we are able to direct our attention exclusively on the growth opportunities of our Endo-bariatric product line. Demand for OverStitch was strong in the fourth quarter as the treatments possible with this unique technology continue to gain physician adoption and as of the beginning of February we are into the full launch of the new single channel compatible OverStitch Sx in the United States and Europe."

Apollo reported Endo-bariatric product revenues of $10.8 million in the fourth quarter of 2018, an increase of 10%. Fourth quarter total revenues which included sales of the divested Surgical product line, were $15.2 million a decrease of 6%. For the year, Endo-bariatric product revenues were $41.1 million, an increase of 15%. Total revenue for the year which includes sales of the divested Surgical products were $60.9 million, a decrease of 5%.

Fourth quarter Endoscopic Suturing System ("ESS") product sales increased 46% to $6.9 million from increases in product utilization in existing accounts and new user adoption. For the year, ESS product sales were $23.4 million, an increase of 42%.

Fourth quarter Intragastric Balloon ("IGB") product sales were $3.9 million, a decrease of 23%. U.S. IGB sales declined 20% due to ongoing market weakness due to negative media impressions following prior FDA communications. OUS IGB product sales decreased 24%, due primarily to lower sales in Brazil and our distributor markets which offset higher sales of Orbera365 in our direct European markets. For the year, IGB product sales were $17.7 million, a decrease of 9%.

Gross margin for the fourth quarter of 2018 was 46.6%, compared to 57.7% for the fourth quarter of 2017 primarily due to a greater proportion of our product sales coming from our ESS products, which realize a lower gross margin than our other products. During the fourth quarter of 2018 we completed two gross margin improvement projects related to both the ESS and IGB products which we expect on a combined basis to improve gross margin by approximately $2 million annually beginning in 2019. Gross margin for the year was 54.5% compared to 61.8% in 2017.

Total operating expenses were $23.9 million in the fourth quarter of 2018 and included a loss on the sale of our Surgical product line of $7.8 million. Excluding this one-time item, operating expenses were $16.2 million in the fourth quarter of 2018, an increase of 6%. Research and development costs increased as a result of expanded clinical study activities related to our Endo-bariatric products, new product development activities, and margin improvement projects. Excluding the loss on sale of the Surgical product line, operating expenses for the year were $65.5 million compared to $62.2 million, an increase of 6% due to higher research and development expenses.

Net loss for the fourth quarter 2018 was $18.4 million compared to $7.3 million for the fourth quarter 2017. For the year, net loss was $45.8 million in 2018 compared to $27.3 million in 2017.

Cash, cash equivalents and restricted cash were $25.0 million as of December 31, 2018.

Debt Financing

On March 15, 2019, we entered into a new credit facility with Solar Capital to borrow $35.0 million. The new facility may provide an additional $15.0 million upon our request, subject to further credit approval. We used $22.4 million of these proceeds to pay off the remainder of our prior credit facility. Interest on borrowings under the new credit facility is payable at

LIBOR plus 7.5% (currently 10.0%). Principal payments will begin after a 24-month interest only period payable on a straight-line basis until maturity on September 1, 2023.

Conference Call

Apollo will host a conference call on Monday, March 18, 2019 at 7:30 a.m. Central Time / 8:30 a.m. Eastern Time to discuss Apollo’s operating results for the fourth quarter and year ended December 31, 2018.

To participate in the conference call dial (877) 823-8673 for domestic callers and (647) 689-4156 for international callers. The conference ID number is 3671589. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.

A replay of the webcast will remain available on Apollo’s website, www.apolloendo.com, following the call. In addition, a transcript of the earnings call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.

On March 18, 2019 Personalis, Inc., a leader in advanced genomics for precision oncology, reported that they are scheduled to present at ICI-IO Combinations Summit 2019 in Boston on Wednesday, March 20, 2019 at 2:30 PM, EDT (Press release, Personalis, MAR 18, 2019, View Source [SID1234534801]).

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The presentation, entitled "Challenges and Solutions: Enabling multidimensional tumor immunogenomics for advancing biomarker discovery," will introduce Personalis’ new universal cancer immunogenomics platform, ImmunoID NeXT. In addition to an overview, the presentation will also highlight how this platform can be used to overcome the challenges facing immuno-oncology translational and clinical researchers. By deriving new insights through our industry leading NGS analysis platform, ImmunoID NeXT provides solutions to enable the development of safer, more effective precision oncology therapeutics and combinations.

ImmunoID NeXT is the first and only platform to provide comprehensive analysis of both a tumor and its microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology; consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Christelle Johnson, PhD, Senior Field Application Scientist, Cancer Genomics & Immuno-Oncology.

On March 18, 2019 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, reported that it has secured a €20 million revolving credit facility with Natixis, the French Corporate and Investment bank (Press release, Transgene, MAR 18, 2019, View Source [SID1234621822]).

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The credit facility will have a 30-month term and Transgene will be able to draw on and repay the facility at its discretion.

Transgene has used its shares in the Chinese biotech company Tasly Biopharmaceuticals as collateral for this loan. As a reminder, Transgene became a Tasly Biopharmaceuticals shareholder in July 2018 and holds 2.5% of its capital as the result of a series of agreements under which Transgene transferred to Tasly Biopharmaceuticals its Chinese rights to T601 and T101, two immunotherapies discovered by Transgene and which are currently being developed by Tasly Biopharmaceuticals in Greater China. Tasly Biopharmaceutials has announced its intention to list its shares on the Hong Kong Stock Exchange.

Jean-Philippe Del, Vice President, Finance, said: "I am glad that we have been able to monetize our shareholding in Tasly Biopharmaceutical to extend our cash runway. With this new loan facility, we now have the funds needed to support our clinical and pre-clinical activities until mid-2020."

On March 17, 2019 Oncoceutics, Inc. reported that the latest efficacy data for the use of ONC201 in adult recurrent H3 K27M-mutant glioma will be presented in an Oral Abstract Session at the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago (Press release, Oncoceutics, MAR 17, 2019, View Source [SID1234558354]). In addition, there will be an update on ONC201 in previously irradiated pediatric H3 K27M-mutant glioma that will be presented in a poster session.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The oral abstract session presentation, entitled "Single agent ONC201 in adult recurrent H3 K27M-mutant glioma" will describe the clinical experience of ONC201, in adults with recurrent H3 K27M-mutant glioma. It will be presented on Monday, June 3rd from 9:24 am to 9:36 am (Abstract 3005) as part of the Developmental Therapeutics and Tumor Biology (nonimmune) session by Isabel Arrillaga, MD, PhD, Associate Clinical Director of Neuro-Oncology at MGH Cancer Center. The presentation will discuss a cohort of adults with H3 K27M-mutant glioma patients who have received ONC201 after failure of available therapies. The results will include assessments of radiographic response, progression-free survival, and overall survival, as well as safety and clinical benefit. This presentation was selected for review by a panel of discussants.

A second data set to be presented is entitled "ONC201 in previously-irradiated pediatric H3 K27M-mutant glioma," and will be presented as a poster by Sharon Gardner, MD, Associate Professor in the Department of Pediatrics at NYU Langone Cancer Center, on Saturday, June 1, from 8:00 am to 11:00 am (Abstract 10046, Poster 428). Dr. Gardner will discuss the emerging safety, pharmacokinetics, and outcome data available from the first arm of the first pediatric clinical trial with ONC201. This trial is currently evaluating the compound in children with DIPG, or other forms of H3 K27M-mutant glioma, who have no meaningful treatment options.

"As someone who was involved from the very beginning in Oncoceutics’ development programs, I am delighted to see the progress in the development of ONC201 for brain tumors that have challenged our abilities in oncology for a long time", said Joseph Bertino, MD, FAACR, Founding Member of the Scientific Advisory Board of Oncoceutics, Past President of ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper), and, amongst the numerous accolades given to him, recipient of the 2018 Award for Lifetime Achievement in Cancer Research. "I am encouraged that the therapeutic concept of addressing GPCRs with imipridones for applications in oncology will materialize as a new paradigm to treat cancer. ONC206 is the next compound from the imipridone portfolio that will enter the clinic, and based on the preclinical profile, including the well characterized binding target and mechanism of action, I expect an efficient translational program."

A team of Oncoceutics team members will be present at the conference. If you have any questions, please contact us at [email protected].

The abstracts are listed below:

Single agent ONC201 in adult recurrent H3 K27M-mutant glioma. Presented Monday, June 3, 2019. View Source
ONC201 in previously-irradiated pediatric H3 K27M-mutant glioma. Presented Saturday, June 1, 2019. View Source

On March 16, 2019 Xynomic Pharma, a clinical stage US-China oncology drug development company, and Bison Capital Acquisition Corp. (Nasdaq: BCAC), reported that China, Spain and Poland authorities have approved Xynomic’s application to conduct potentially pivotal Phase 3 trial using Xynomic’s abexinostat, in combination with pazopanib, in patients with renal cell carcinoma (RCC) (Press release, Xynomic Pharmaceuticals, MAR 16, 2019, View Source [SID1234534403]). Xynomic plans to initiate this trial in China, Spain, Poland and additional European countries in the first half of 2019. The same trial is currently ongoing in the United States and South Korea. According to a June 2018 research report by Grand View Research, RCC accounts for 1.8% of total adult malignancies globally and 3.4% of all new cancer cases in the United States. The global RCC pharmaceuticals market size is projected to reach US$ 4.6 billion in 2019.

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In addition, the Independent Ethics Committee at the Cancer Hospital Chinese Academy of Medical Sciences in Beijing, China’s number one ranked cancer specialty hospital according to Fudan University’s Hospital Management Institute, has approved Xynomic’s application to conduct two potentially pivotal Phase 2 trials, one to test abexinostat as a third-line mono therapy against diffuse large B-cell lymphoma (DLBCL) and the other as a third-line mono therapy against follicular lymphoma (FL). According to Chinese Medical Association’s Chinese Society of Hematology, DLBCL and FL are the most prevalent and second most prevalent non-Hodgkin’s lymphoma subtype, respectively, in China