On March 18, 2019 Cytovation AS, a privately held biotech company, reported that the first patients have been treated in a Phase I clinical study with CyPep-1, a novel therapeutic agent being developed as a new topical therapy for HPV-induced warts (Press release, Cytovation, MAR 18, 2019, View Source [SID1234561559]). The initiation of this clinical trial marks the start of the clinical development of CyPep-1 in dermatology and oncology applications, with a Phase I trial of CyPep-1 in malignant tumors planned to start in the second half of 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

First patients treated in a Phase I study with CyPep-1 as an investigational therapy for benign, HPV-induced cutaneous tumors (warts).
Novel targeted lytic mechanism offers broad application for multiple indications.
Further clinical trial in malignant tumors to start in 2H 2019.
CyPep-1 has been designed and developed by Cytovation. It is a first-in-class lytic agent with broad application across benign and malignant tumors as a result of its novel mechanism of action. CyPep- 1 selectively targets tumor cells, forming pores that destabilise and rupture the membrane to kill the cell and release neoantigens into the microenvironment and circulation, while leaving healthy cells intact. The release of neoantigens enables cytotoxic CD8 positive T-cells to mount a systemic immune response offering the possibility of long-lasting immunity against the tumor and, in the case of warts, HPV infection. For more information about the mode of action, click here.

Cytovation has formulated CyPep-1 as a cream for the topical treatment of HPV-induced warts, a large medical need for which there are currently no approved drug therapies. The Company has also developed CyPep-1 as a solution for intra-tumoral injection, as a single agent or in combination with checkpoint inhibitors.

Cytovation’s Chief Scientific Officer, Lars Prestegarden, said: "We are very pleased to achieve this first clinical milestone with CyPep-1 and to begin its formal clinical development. We have designed CyPep-1 to exploit key differences between healthy and tumor cells and have seen strong evidence of its efficacy in preclinical tumor models. We are excited to see if these results can be translated to humans both with this new trial in warts and the future trial in cancer. Both trials are expected to start during 2019 and we are looking forward to reporting first findings later in the year."

The clinical trial with CyPep-1 is a randomized, placebo-controlled, double-blind Phase I study. The study is being conducted at the Centre for Human Drug Research (Leiden, the Netherlands) and will enrol 58 patients with cutaneous warts. Results are expected in the late 2019. (ClinicalTrials.gov Identifier: NCT03846648).

On March 18, 2019 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that its 2018 financial results will be released after market close on Tuesday, March 19th (Press release, DiaMedica, MAR 18, 2019, View Source [SID1234534426]). DiaMedica’s management will host a live conference call on Wednesday, March 20th at 8:00am Central Time to provide a business update and discuss the Company’s financial results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Conference Call details:

Date: March 20, 2019
Time: 8:00 AM CT
Web access: View Source
Dial In: (866) 962-3593 (domestic)
(630) 652-5857 (international)
Conference ID: 6773627
Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until March 28, 2019, by dialing 1(855) 859-2056 (US Toll Free Dial In), (404) 537-3406 (international), replay passcode 6773627.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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 CSI Laboratories, a nationally renowned laboratory specializing in comprehensive cancer diagnostics, reported that it has added the newly approved VENTANA PD-L1 (SP142) Assay as a companion diagnostic test for use in selecting triple-negative breast cancer (TNBC) patients for TENCENTRIQ (atezolizumab) (Press release, CSI Laboratories, MAR 18, 2019, View Source [SID1234534427]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

TENCENTRIQ was granted accelerated approval for use in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 on March 8, 2019. The indication is approved under accelerated approval based on progression-free survival and continued approval may be contingent on verification and description of clinical benefit in confirmatory trials, according to the FDA.

CSI is one of the first reference laboratories to offer the new companion test. The new Assay is used to determine PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area.

"We are pleased to add this companion test to our diagnostic testing services, which will enable health care teams to treat TNBC patients with newer therapeutic options," said Ron Ghafary, founder and CEO of CSI Laboratories. "We continue to focus on providing a superior client experience, exceptional and accurate lab results, and quick turnaround to help our clients provide personalized cancer care to their patients."

For more information, please visit csilaboratories.com or contact Eric Diersen 678-248-8000.