On November 7, 2019 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported its financial results for the third quarter ended September 30, 2019, and provided an update on the Company’s recent activities (Press release, Ziopharm, NOV 7, 2019, View Source [SID1234550707]).

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"Our company took dramatic steps forward in the past quarter, in particular with our TCR-T platform," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "The NCI advanced the TCR program using our Sleeping Beauty platform into a phase 2 trial and our new agreement with MD Anderson accelerates expansion of our TCR library and sets the foundation for two new clinical trials to be conducted there by Ziopharm. Our confidence surges as we have partnered with these leading institutions in tackling the massive, untapped market in solid tumors."

Program Updates

Sleeping Beauty TCR-T

The Company is using its non-viral gene transfer technology to implement personalized T-cell therapy targeting solid tumors with neoantigen-specific TCRs. Under a Cooperative Research and Development Agreement (CRADA), the NCI is undertaking a phase 2 clinical trial to treat patients with metastatic/advanced solid tumors using the Company’s Sleeping Beauty transposon/transposase platform to genetically modify patient-derived T cells with TCRs to target patient-specific neoantigens.

Phase 2 Sleeping Beauty TCR-T cell therapy trial at NCI: In recent weeks, the NCI has provided details of the initiated clinical trial in solid tumors to evaluate TCR T-cell therapy utilizing Ziopharm’s Sleeping Beauty platform: A Phase 2 Study Using the Administration of Autologous T-Cells Engineered Using the Sleeping Beauty Transposon/Transposase System to Express T-Cell Receptors Reactive Against Mutated Neoantigens in Patients With Metastatic Cancer (NCT0402436). Under the direction of Steven Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI, and his team, the trial will enroll patients with a range of solid cancers.

New agreement with MD Anderson Cancer Center accelerates TCR hotspot library expansion and enables future Ziopharm clinical trials: Ziopharm announced last week a new research and development agreement with MD Anderson for the Sleeping Beauty immunotherapy program to use non-viral gene transfer to stably express and clinically evaluate neoantigen-specific TCRs in T cells. This agreement will accelerate expansion of the library of TCRs against neoantigens in hotspots including mutated KRAS, TP53 and EGFR licensed from NCI earlier this year. Additionally, this agreement provides the foundation for two new Ziopharm TCR-T clinical trials to be conducted at MD Anderson: a trial for utilizing TCRs from the library targeting hotspot mutations, and a second trial for personalized TCRs targeting patient-specific neoantigens.

Sleeping Beauty CAR-T

Ziopharm is advancing the Sleeping Beauty platform for the rapid personalized manufacture (RPM) of CD19-specific CAR-T, co-expressing membrane bound IL-15 (mbIL15) with a safety switch. Per the IND, RPM produces T cells with viability of at least 70% that can be infused the day after gene transfer. This work on our third-generation Sleeping Beauty technology is undertaken in collaboration with MD Anderson Cancer Center in the United States and in Greater China through a joint venture, Eden BioCell.

FDA Cleared IND for phase 1 trial for RPM of CD19-specific CAR-T: In October, the Company announced that FDA cleared an IND for a phase 1 clinical trial to assess CD19-specific CAR-T, produced using RPM. The study will be conducted at MD Anderson as an investigator-initiated trial. Patients with CD19+ leukemias and lymphomas who have relapsed after allogeneic bone marrow transplantation will be enrolled to evaluate infusion of donor-derived RPM CAR-T.

Abstract accepted at 2019 ASH (Free ASH Whitepaper) Annual Meeting: Investigators will present preclinical data on the benefit of mbIL15 on the rapid personalized manufacture (RPM) of TCR-T at the 2019 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December.

Controlled IL-12

Ziopharm is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, to control the production of human interleukin 12 (hIL-12) which activates the immune system to recruit and sustain cancer-fighting T cells within solid tumors. Ziopharm is advancing Ad-RTS-hIL-12 plus veledimex for the treatment of recurrent glioblastoma multiforme (rGBM) as monotherapy and in combination with immune checkpoint inhibitors. In August, supportive data from the phase 1 monotherapy trial were published in Science Translational Medicine.

Enrollment completed in third cohort of combination study with OPDIVO (nivolumab): Ziopharm announced in June that it had completed enrollment in three dosing cohorts in its phase 1 study of adult patients with rGBM to evaluate a single dose of Ad-RTS-hIL-12 plus daily veledimex in combination with OPDIVO, an immune checkpoint inhibitor against programmed death-1 (PD-1). Investigators from this multi-center trial indicated interest in expanding the study and have enrolled all 12 additional patients at the highest dosing level.

Phase 2 combination trial with Regeneron’s Libtayo (cemiplimab-rwlc) initiated in June: The Company, in collaboration with Regeneron Pharmaceuticals, initiated a phase 2 trial at the end of the second quarter to evaluate Ad-RTS-hIL-12 plus veledimex in combination with

Regeneron’s PD-1 antibody Libtayo to treat patients with rGBM. As prescribed in the study protocol, the first six patients have been dosed, and are completing the required monitoring period prior to the resumption of enrollment. The Company expects to enroll about 30 patients at approximately 10 sites.

Abstracts accepted at 2019 SNO Annual Meeting: Investigators will present data from two ongoing trials in the Controlled IL-12 platform, both as monotherapy and in combination with OPDIVO, in two posters at the 2019 Annual Meeting of the Society for Neuro-Oncology (SNO) in November.

EMA grants Orphan Drug status to Controlled IL-12 program: Ziopharm announced in August that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted a positive opinion recommending Controlled IL-12 for designation as an orphan medicinal product for the treatment of glioma, which has subsequently been adopted by the European Commission.

Corporate Updates

Balance sheet strengthened: Early in the third quarter, a group of Ziopharm shareholders, led by MSD Partners, L.P., exercised their existing warrants to purchase common stock, which resulted in gross proceeds of approximately $52 million. With more than $88 million in cash at the end of the third quarter, Ziopharm has sufficient capital to fund operations into the first half of 2021 and provide visibility into important clinical data milestones for the Company’s TCR-T, CAR-T and Controlled IL-12 programs.

Expanded Ziopharm Laboratory and Office on MD Anderson Campus: Concurrent with the new R&D agreement with MD Anderson announced last week, through a new lease Ziopharm is also significantly expanding its R&D footprint on the MD Anderson campus.

Dr. Chris Bowden joins Board of Directors: In October, Ziopharm appointed Chris Bowden, M.D., an oncology drug development executive with more than 20 years leadership experience spanning pre-clinical development through commercialization, including the approval of several cancer medicines, to the Company’s Board. The addition of Dr. Bowden represents the sixth new board member for Ziopharm in the past 18 months.

Third Quarter 2019 Financial Results

The Company recorded a one-time, non-cash charge during the quarter of $60.8 million associated with the warrant exercise transaction.

Reflecting the $60.8 million, ($0.36) per share, non-cash charge, the net loss applicable to the common shareholders for the third quarter of 2019 was $74.0 million, or $(0.43) per share, compared to a net loss of $18.7 million, or $(0.13) per share, for the third quarter of 2018.

Research and development expenses were $8.6 million for the third quarter of 2019, compared to $8.3 million for the third quarter of 2018.

General and administrative expenses were $4.8 million for the third quarter of 2019, compared to $4.3 million for the third quarter of 2018.

The Company ended the quarter with unrestricted cash resources of approximately $88 million.

In addition, a prepayment of approximately $21.5 million remains for programs to be conducted by the Company at MD Anderson under the current Research and Development Agreement.

Conference Call and Webcast

Scheduled for today at 4:30 pm ET, the conference call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 8279471. To access the live webcast or the subsequent archived recording, visit the "Investors" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.-

On November 7, 2019 Triple-S Management Corporation (NYSE: GTS), a leading managed care company in Puerto Rico, reported its third quarter 2019 results (Press release, Triple-S Management, NOV 7, 2019, https://www.prnewswire.com/news-releases/triple-s-management-corporation-reports-third-quarter-2019-results-300953651.html [SID1234550706]).

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Quarterly Consolidated and Other Highlights

Net income of $13.9 million, or $0.58 per diluted share, versus net loss of $17.6 million, or $0.77 per share, in the prior-year period;
Adjusted net income of $12.1 million, or $0.51 per diluted share, versus adjusted net loss of $22.2 million, or $0.97 per share, in the prior-year period;
Operating revenues of $836.0 million, a 9.4% increase from the prior-year period, primarily reflecting higher Managed Care net premiums earned;
Consolidated loss ratio decreased 400 basis points to 83.4% versus the third quarter of 2018; this results from the unfavorable reserve development related to Hurricane Maria claims recognized by the Property and Casualty ("P&C") segment in the prior-year period;
Medical loss ratio ("MLR") increased 320 basis points to 86.4%;
Consolidated operating income was $19.0 million, compared to consolidated operating loss of $25.6 million in the prior-year period;
Expansion of share repurchase program to $25 million of availability, approved subsequent to quarter end.
"We had a solid third quarter, mainly driven by year-over-year growth in Medicare premiums and valuable bottom line contributions from our Life and P&C segments," said Roberto Garcia-Rodriguez, President and Chief Executive Officer. "We’ve continued strengthening our product offerings, improving the overall quality of service, and advancing our goal of creating a unique and optimal member experience."

"With respect to our P&C segment, our quarterly review of outstanding claims reaffirms our belief that our reserves remain adequate as of September 30, 2019," added Mr. Garcia-Rodriguez. "Given our confidence in the Company’s long-term strategy and our belief that its stock is undervalued, our Board has expanded our share repurchase program’s availability to $25 million. We anticipate commencing repurchases under the program during the week of November 11, 2019."

Selected Consolidated Quarterly Details

Consolidated net premiums earned were $815.0 million, up 9.8% from the prior-year period, primarily reflecting higher average premium rates within the Managed Care segment and an increase in membership in the Medicare and fully insured Commercial businesses. The increase was partially offset by lower Medicaid membership.
Consolidated claims incurred were $680.0 million, up 4.8% year-over-year. Consolidated loss ratio of 83.4% improved 400 basis points from the prior-year period, driven by the $52.3 million unfavorable prior period reserve development related to Hurricane Maria recognized by the P&C segment in the third quarter of 2018 that did not recur in the third quarter of 2019.
Consolidated operating expenses of $136.9 million decreased by $4.1 million, or 2.9%, from the prior-year period, primarily resulting from savings due to the suspension in 2019 of the HIP Fee, partially offset by higher personnel costs and commission expense. The Company’s operating expense ratio improved 220 basis points year-over-year to 16.7%, mostly driven by the increase in premiums during the third quarter of 2019.
Consolidated income tax expense was $5.9 million, compared to an income tax benefit of $3.4 million in the prior-year period. The income tax benefit in the third quarter of 2018 mainly reflects the loss before taxes in that period incurred by the P&C segment.
Selected Managed Care Segment Quarterly Details

Managed Care premiums earned were $746.5 million, up 9.7% year over year.
Medicare premiums earned of $367.1 million increased 29.4% from the prior-year period, largely due to an increase of approximately 52,000 member months and higher average premium rates, primarily reflecting a more competitive product offering and an increase in the average membership risk score.
Commercial premiums earned of $203.1 million increased 2.9% from the prior-year period, mainly reflecting higher fully insured enrollment during the quarter of approximately 25,000 member months and higher average premium rates, partially offset by the suspension of the HIP Fee pass-through in 2019.
Medicaid premiums earned decreased 11.8% from the prior-year period to $176.3 million, primarily reflecting a decrease in membership of approximately 126,000 member months, and the suspension of the HIP Fee pass-through in 2019. The decrease in membership follows the lower membership assigned to Triple-S by ASES when implementing the new Medicaid contract that became effective November 1, 2018.
Reported MLR of 86.4% increased 320 basis points from the prior-year period. This increase largely reflected the improved benefits offered in the Medicare Advantage 2019 product offering, the elimination of the HIP Fee pass-through, and the higher target MLR of the current Medicaid contract.
Update on P&C Segment Reserves related to Hurricane María

As of September 30, 2019:

Triple-S Propiedad, Inc. (TSP), the Company’s P&C subsidiary, has paid a cumulative amount of $692 million in claims related to Hurricane María. Estimated gross losses remain unchanged at $967 million.
TSP received 10 new claims during the third quarter, increasing the total number of claims to 17,746. It has closed approximately 96% of these claims. 709 claims remain open.
The Company evaluated any developments involving open claims, including new information that arose from lawsuits in which TSP has been served, as is customary when the Company conducts its quarterly review of TSP’s reserve levels. In addition, as described below, the Company conducted additional analysis of case reserves for claims in which lawsuits have been filed against TSP but not served.
TSP has been served with process in 218 lawsuits related to the 709 claims that remain open.
The Company conducted a search of the Puerto Rico court system’s electronic docket to identify lawsuits filed against TSP with respect to which TSP has not been served. This docket is a public record over which the Company has no control; furthermore, the Company is unable to verify its accuracy or completeness.
The docket search identified an additional 178 lawsuits filed against TSP that have not yet been served as required by law. All of them relate to claims previously registered with and evaluated by the Company.
The Company then performed additional analysis of case reserves for claims in which lawsuits have been filed against TSP but not served. Based on this analysis, as well as the customary review described above, the Company determined that there is no need to increase its estimate of gross losses nor adjust reserves related to Hurricane María.
As is the case for all claim liabilities, the gross losses related to Hurricane Maria are based on the Company’s best estimate of the ultimate expected cost of claims with the information currently on hand and are subject to change.
Results of Internal Investigation Related to Vital RFP

As previously disclosed in an 8-K filed with the Securities and Exchange Commission on July 30, 2019, the Company’s audit committee of independent directors engaged outside counsel to conduct a proactive investigation into the Company’s participation in the Vital RFP process. That investigation is substantially complete and has not uncovered any evidence of attempts by the Company to improperly influence the outcome of the Vital RFP process.

2019 Outlook

The Company is raising its full year 2019 guidance for adjusted net income per diluted share and reducing its guidance for operating expense ratio. It is maintaining its full year 2019 guidance for its consolidated operating income revenue, Managed Care premiums, consolidated claims incurred ratio and Managed Care MLR ratio. More specifically:

The Company continues to expect consolidated operating revenue for 2019 to be between $3.29 billion and $3.33 billion, which includes Managed Care premiums earned, net between $2.95 billion and $2.99 billion;
The Company continues to expect the consolidated claims incurred ratio for 2019 to be between 81.3% and 83.3%, and Managed Care MLR to be between 84.0% and 86.0%;
The Company is reducing consolidated operating ratio expectations for 2019 to be between 16.75% and 17.25%. The Company’s previous outlook was for consolidated operating expense ratio to be between 17.0% and 17.5%;
The Company continues to expect its effective tax rate to be between 29.0% and 33.0%; and
The Company raised adjusted net income per diluted share expectations for 2019 to be between $2.50 and $2.70, compared to its previous outlook for adjusted net income per diluted share between $2.40 and $2.60. Adjusted net income per diluted share guidance accounts for the August 2019 share dividend and does not account for any potential share repurchase activity during 2019. Estimated weighted average diluted share count for full year 2019 is expected to be 23.443 million shares.
Conference Call and Webcast

Management will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss its financial results for the three months ended September 30, 2019. To participate, callers within the U.S. and Canada should dial 1-877-451-6152 and international callers should dial 1-201-389-0879 at least five minutes before the call.

To listen to the webcast, participants should visit the "Investor Relations" section of the Company’s website at www.triplesmanagement.com several minutes before the event is broadcast and follow the instructions provided to ensure they have the necessary audio application downloaded and installed. This program is provided at no charge to the user. An archived version of the call, also located on the "Investor Relations" section of Triple-S Management’s website, will be available about two hours after the call ends and for at least the following two weeks. This news release, along with other information relating to the call, will be available on the "Investor Relations" section of the website.

In addition, a replay will be available through November 21, 2019 by calling 1-844-512-2921 or 1-412-317-6671 and entering passcode 13695866. A replay will also be available at www.triplesmanagement.com for 30 days.

On November 7, 2019 Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, reported that Brian J. Brille, Vice Chairman of the Company, will present at two upcoming investor healthcare conferences in New York City (Press release, Caris Life Sciences, NOV 7, 2019, View Source [SID1234550705]). Presentation details are as follows:

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Stifel 2019 Healthcare Conference
Wednesday, November 20, 2019, at 10:20 a.m. Eastern Time,
Lotte New York Palace Hotel, Winslow Room
Canaccord Genuity Group 2019 Medical Technologies & Diagnostics Forum
Thursday, November 21, 2019, at 11:00 a.m. Eastern Time,
The Westin Grand Central, Ambassador Room
Mr. Brille will provide an overview of Caris’ business at the conferences and discuss recent corporate achievements that position the Company to further extend its leadership in precision medicine. He will also take questions from the audience following each presentation.

Investors attending either conference who would like to schedule a one-on-one meeting with Caris executives may do so by contacting their representatives at Stifel or Canaccord Genuity Group, respectively.

On November 7, 2019 VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, reported financial results for its fiscal year 2020 second quarter ended September 30, 2019 (Press release, VistaGen Therapeutics, NOV 7, 2019, View Source [SID1234550704]).

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"During the quarter, we achieved several important milestones intended to advance development of each of our three differentiated CNS drug candidates," stated Shawn Singh, Chief Executive Officer of VistaGen. "We recently achieved target enrollment and completed patient dosing in our randomized, double-blind, placebo-controlled Phase 2 ELEVATE study of AV-101, our novel oral NMDA receptor antagonist, in major depressive disorder. In addition, for development of AV-101 in suicidal ideation, with emphasis on U.S. Military Veterans, our collaborators at Baylor University recently completed dosing in their Phase 1b target engagement study in healthy volunteer Veterans, a study funded by the U.S. Department of Veteran’s Affairs. We are also encouraged by post-Phase 2 feedback from the FDA earlier this year regarding our Phase 3 development plan for PH94B, our first-in-class, rapid-acting neuroactive nasal spray, in social anxiety disorder. We expect the coming months to be equally active and potentially transformative, as we look forward to topline readouts from two studies involving AV-101 before the end of 2019, and potential regulatory milestones involving PH94B before the end of fiscal 2020."

Financial Results for the Fiscal Quarter Ended September 30, 2019:

Net loss attributable to common stockholders for the fiscal quarter ended September 30, 2019 decreased to approximately $5.7 million compared to $7.7 million for the fiscal quarter ended September 30, 2018, primarily attributable to research and development activities relating to the Company’s CNS drug development programs.

Research and development expense decreased to $4.2 million for the fiscal quarter ended September 30, 2019, compared with $5.3 million for the fiscal quarter ended September 30, 2018. Expense for the quarter ended September 30, 2018 included $2.25 million noncash expense associated with the Company’s acquisition of its exclusive worldwide license to develop and commercialize PH94B and an option to acquire an exclusive worldwide license to develop and commercialize PH10, the Company’s first-in-class, rapid-onset neuroactive nasal spray in Phase 2 development for major depressive disorder, which option was subsequently exercised. Offsetting this noncash expense in the quarter ended September 30, 2019 are increased expenses for the ELEVATE study and various nonclinical activities across the Company’s CNS pipeline.

General and administrative expense decreased to approximately $1.1 million in the fiscal quarter ended September 30, 2019, compared to approximately $2.2 million in the fiscal quarter ended September 30, 2018. Noncash expense of $272,000 in the quarter ended September 30, 2019, decreased from $792,000 in the quarter ended September 30, 2018, primarily due to decreases in stock-based compensation and other expenses.

At September 30, 2019, VistaGen had cash and cash equivalents of $4.1 million, compared to $13.1 million at March 31, 2019.

As of November 6, 2019, there were 43,222,965 shares of common stock outstanding.

VistaGen’s CNS Pipeline

VistaGen is developing three new generation clinical-stage CNS drug candidates, AV-101, PH10 and PH94B, each with a differentiated mechanism of action, an exceptional safety profile in all clinical studies to date, and therapeutic potential in multiple CNS markets where current treatments are inadequate to meet high unmet patient needs.

AV-101 belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA (N-methyl-D-aspartate) receptor modulators. The NMDA receptor is a pivotal receptor in the brain and abnormal NMDA function is associated with numerous CNS diseases and disorders. AV-101 is an oral prodrug of 7-Cl-KYNA, a potent and selective full antagonist of the glycine co-agonist site of the NMDA receptor. Based on several positive preclinical studies and its exceptional safety profile in all preclinical and clinical studies to date, AV-101 has potential to be a new at-home, non-sedating treatment for multiple large market CNS indications, including major depressive disorder, neuropathic pain, suicidal ideation, epilepsy and dyskinesia associated with levodopa therapy for Parkinson’s disease. The FDA has granted Fast Track designation for development of AV-101 as both a novel potential adjunctive treatment for MDD and a non-opioid treatment for neuropathic pain.

PH10 is a first-in-class, odorless, rapid-onset CNS neuroactive nasal spray in development for treatment of major depressive disorder. Administered in microgram doses, PH10 activates nasal chemosensory receptors that, in turn, engage neural circuits that lead to rapid antidepressant effects without psychological side effects, systemic exposure or safety concerns often associated with current oral antidepressants and ketamine-based therapies (intravenous ketamine or esketamine nasal spray). In an exploratory (n=30) randomized, double-blind, placebo-controlled Phase 2a clinical study in major depressive disorder, at microgram doses, rapid-onset antidepressant effects were observed and sustained for 8 weeks, without psychological side effects or systemic exposure. VistaGen is preparing for planned Phase 2b clinical development of PH10 for major depressive disorder.

PH94B is a first-in-class, odorless, rapid-onset (approximately 10 to 15 minutes) CNS neuroactive nasal spray with the potential to be the first FDA-approved, as-needed, on-demand treatment for millions of Americans who suffer from social anxiety disorder, with additional potential in peripartum anxiety, pre/postoperative anxiety, post-traumatic stress disorder, panic disorder and generalized anxiety disorder. Administered at microgram doses, PH94B activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety associated with everyday social and work or performance situations. Following successful Phase 2 development, VistaGen is preparing for Phase 3 clinical development of PH94B for social anxiety disorder.

On November 7, 2019 Selvita (WSE: SLV) – one of the largest preclinical contract research organizations in Europe – reported third quarter 2019 financial results and provided a corporate update following a recent corporate split of the oncology therapeutics (Ryvu Therapeutics) and contract research (CRO) business units (Selvita) (Press release, Selvita, NOV 7, 2019, View Source [SID1234550703]).

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The services segment of the Company has recorded USD 5.59 million of commercial revenue in Q3 2019, which marks a 45% increase compared to Q3 2018.

In the first three quarters of 2019, Selvita Group recorded USD 18.8 million of revenues, 32% increase comparing to the corresponding period in 2018. Operating profits, (EBITDA excluding IFRS16 impact) result amounted to USD 3.5 million, an increase of 21% compared to Q3 2018, and the backlog **for 2019 currently amounts to USD 25.1 million and is 38% higher than at corresponding time in 2018.

– Our financial results up to date represent more than we wished for. The increase in the commercial revenues was significantly higher than the declared 30%, as it amounted to 36% in the period from January to September, and 45% in Q3 2019 alone. Operating margin for Q1-Q3 2019 amounted to 11.4% – says Boguslaw Sieczkowski, co-founder, significant shareholder and Chief Executive Officer at Selvita.

Revenues of the services segment in the first three quarters amounted to USD 15.1 million, up by 36% comparing to Q1-Q3 2018, and operating profit to USD 2.0 million (11% more y/y). In the third quarter alone, these dynamics reached 45 and 13%, respectively.

– The last quarters of this year were a period of a dynamic development for Selvita. Not only we have increased employment, but also made significant investments in the equipment. This has allowed us to build a solid base for another organic leap of business scale. The first results of our work were already visible in Q3 2019 – says Boguslaw Sieczkowski.

The service segment is comprised of two departments: chemistry and biology. In 2019, the dynamics of the biology department have stood out in particular – its backlog currently amounts to USD 9.9 million and is 75% higher than for a corresponding point of time in 2018.

The total commercial backlog of the service segment currently sums up to USD 20.9 million, a 40% increase compared to 2018.

Revenues of the bioinformatics segment (Ardigen, in which Selvita S.A. holds 52 percent of shares), amounted to USD 2.5 million and were 32% higher than in Q3 2018. Operating profit amounted to USD 0.2 million, compared to USD 0.3 million in the same period last year.

– At the moment, Ardigen’s primary goal is dynamic development of its own technology platforms, as well as marketing and sales activities. This drives the increase in costs, but in the long run it will lead to a significant growth in the scale of business, resulting in the increase in the value of the company – explains Bogusław Sieczkowski.

The backlog of the bioinformatics segment amounts to USD 2.6 million, which is 27% higher than a year ago.

Selvita after the split

At the beginning of October, the National Court Register of Poland ("KRS") has recognized the corporate split of the Selvita parent company into two distinct organizations. The recognition by the court follows the Sept. 19, 2019, shareholder resolution to separate oncology therapeutics and contract research (CRO) business units.

Selvita provides comprehensive research and development services, mainly to clients in the pharmaceutical and biotechnology industries. The company’s medium-term goal is to enter the top ten largest preclinical CROs in the world.

Selvita’s Services Segment has been growing in the last years at a rate of 30-40% per year and has been permanently profitable. The company assumes maintaining this level of growth dynamics. At the same time, the company plans to grow through acquisitions, expecting the first transaction in 2020. Selvita is interested both in domestic and foreign companies which will allow it to achieve its business goals: increasing the scale of operations and expanding the portfolio of services offered. As a leading company on the market, Selvita will be in an excellent position to build lasting value, thanks to selective and systematic takeover strategies, which will be made possible through e.g. debt financing, which was difficult to access before the corporate split.

Boguslaw Sieczkowski, serves currently as the Chief Executive Officer at Selvita. He is also one of the co-founders of the company, and former Executive Vice President and Chief Operating Officer. In addition, the Management Board is comprised of three members from the company’s current top management: dr Milosz Gruca, Director of the Biology Department and Executive Vice President, dr Miroslawa Zydron, Director of the Chemistry Department and Edyta Jaworska responsible for the development of integrated drug discovery projects. New appointments to the Management Board have also been made, which include Dawid Radziszewski, General Counsel and Head of Corporate Development who will be directly responsible for the acquisitions and integration of companies within the Group, and Dariusz Kurdas, who assumed the position of Chief Financial Officer.

**Backlog for 2019 as on 28/10/2019, backlog for 2018 as on 9/11/2018. Backlog defined as the value of the portfolio of contracts signed as of the report publication date, incl. commercial contracts and grant agreements.