On March 5, 2019 Dova Pharmaceuticals, Inc. (Nasdaq: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for diseases where there is a high unmet need, reported its operating and financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Dova Pharmaceuticals, MAR 5, 2019, View Source [SID1234533984]).

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"Following the management changes announced in December 2018, we worked expeditiously to implement changes to our commercialization strategy for DOPTELET. We are encouraged with the initial feedback and results from these efforts and remain confident in the significant commercial opportunity for DOPTELET," said Dr. David Zaccardelli, President and Chief Executive Officer of Dova. "In addition, we are pleased by the FDA acceptance of DOPTELET’s supplemental New Drug Application (sNDA) for review in the treatment of chronic ITP which would provide a new treatment option for patients with ITP as well as a long-term growth opportunity for DOPTELET. Finally, we remain well-positioned financially, with over $100 million in cash and equivalents as of December 31, 2018 to fund our operations."

DOPTELET Launch Highlights

The US sales team was restructured on January 4, 2019, now comprised of 44 sales representatives and 5 regional directors. This team is accountable for driving DOPTELET sales in hepatology, hematology, and interventional radiology, while Dova’s co-promotion partner, Salix, has responsibility for GI, colorectal surgeon and proctology practices.

New DOPTELET marketing efforts are underway and Dova expects to launch a revised strategy in the second quarter of 2019.

Additional key hires were made on the commercial team including the head of sales and VP of marketing.

From launch through December 31, 2018, a total of 694 health care professionals have prescribed DOPTELET to their patients with an increasing number of repeat prescribers.

More than 21,000 calls were conducted, reaching more than 8,700 unique health care providers during the fourth quarter of 2018.

For prescriptions in the fourth quarter that have gone through the adjudication process with the payers, 83% of those prescriptions were approved. On average the time to decision for a prescription was 6.3 business days in the quarter.

Inventory held by specialty pharmacies in Dova’s contracted network decreased by approximately 34% from October 1, 2018 to December 31, 2018. The inventory decrease was driven by shipments to patients more than doubling in the fourth quarter of 2018 as compared to the prior quarter.

Fourth Quarter Highlights

The U.S. Food and Drug Administration (FDA) accepted for review Dova’s sNDA for DOPTELET for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The sNDA for ITP is primarily supported by safety and efficacy data from two Phase 2 clinical trials and a randomized, placebo-controlled Phase 3 clinical trial that met its primary and secondary efficacy endpoints with high statistical significance. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is June 30, 2019.

Following the submission in April 2018 of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for DOPTELET for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure, Dova expects a decision date for the MAA in the third quarter of 2019.

Enrollment remains ongoing for the Phase 3 clinical trial for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT). Due to Dova’s decision to focus on developing DOPTELET for ITP and CIT, Dova has discontinued enrollment in the clinical trial evaluating the treatment of a broader population of patients with thrombocytopenia undergoing surgery (PST) and a post-marketing registry study for CLD patients.

On December 17, 2018, Dr. David Zaccardelli was appointed President and Chief Executive Officer, and Jason Hoitt was appointed Chief Commercial Officer.

Fourth Quarter and Full Year Financial Results

Dova reported a net loss of $19.3 million for the fourth quarter of 2018, compared to a net loss of $9.3 million for the same period in 2017. For the full year ended December 31, 2018, Dova reported net loss of $72.3 million compared to a net loss of $30.0 million for the same period in 2017.

Net product sales were $2.8 million and $7.7 million for the fourth quarter of 2018 and the full year ended December 31, 2018, respectively.

Cost of product sales were $0.3 million and $1.2 million for the fourth quarter of 2018 and full year ended December 31, 2018, respectively.

Research and development expenses were $5.5 million in the fourth quarter of 2018, compared to $2.7 million for the same period in 2017. The increase was primarily due to the initiation of clinical trials to evaluate DOPTELET for the treatment of PST and CIT in 2018. For the full year ended December 31, 2018, research and development expenses were $18.3 million compared to $15.7 million in the same period in 2017. Non-cash stock-based compensation included in research and development expenses for the year ended December 31, 2018 amounted to $2.1 million.

Selling, general and administrative expenses were $16.1 million in the fourth quarter of 2018, compared to $6.5 million for the same period in 2017. The increase was primarily due to staffing and other costs associated with the launch of DOPTELET as well as additional costs necessary for operating as a public entity. For the full year ended December 31, 2018, general and administrative expenses were $61.9 million compared to $13.5 million for the same period in 2017. Non-cash stock-based compensation included in selling, general and administrative expenses for the year ended December 31, 2018 amounted to $10.1 million.

As of December 31, 2018, Dova had $104.6 million in cash and equivalents compared to $94.8 million as of December 31, 2017.

Company to Host Conference Call

Dova will host a conference call today, March 5, 2019 at 9:00 a.m. ET to discuss fourth quarter and full year ended December 31, 2018 financial results as well as recent operational highlights. A question-and-answer session will follow Dova’s remarks.

To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 4964448 five to 10 minutes before the start of the call.

A live audio webcast of the call will also be available via the "Investor Relations" page of the Dova website, www.dova.com. Please log on through Dova’s website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on Dova’s website for 90 days following the call.

Indication and Important Safety Information

INDICATION

DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

CONTRAINDICATIONS:

None

ADVERSE REACTIONS:

Most common adverse reactions (≥ 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

Please see full Prescribing Information for DOPTELET (avatrombopag) www.doptelet.com

On March 5, 2019 LabCorp (NYSE: LH) reported it will participate at the 2019 Barclays Global Healthcare Conference (Press release, LabCorp, MAR 5, 2019, View Source [SID1234533983]. LabCorp’s presentation is planned for Tuesday, March 12, 2019, at 8:30 a.m. (ET).

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A live audio webcast of the presentation will be available via the Company website at www.LabCorp.com and archived for replay.

On March 5, 2019 Ziopharm Oncology, Inc. (Nasdaq:ZIOP) reported its financial results for the fourth quarter and year ended December 31, 2018, and provided an update on the Company’s recent activities (Press release, Ziopharm, MAR 5, 2019, View Source [SID1234533982]).

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"We are executing on our strategy to focus on solid tumors with our Sleeping Beauty TCR-T program and our Controlled IL-12 platform and advancing a solution that addresses the cost and complexity of CAR-T therapies," said Laurence Cooper, M.D., Ph.D., CEO of Ziopharm. "Under our collaboration at the National Cancer Institute (NCI), we expect to begin treating patients with solid tumors mid-year with the first non-viral, neoantigen-specific TCR-T cell therapy designed to attack the very mutations that cause cancer. In addition, we are advancing – in both the United States and greater China – our non-viral CAR-T therapy to solve the issues standing in the way of commercial success for approved CD19-specific CAR-T therapies. And, with maturing data showing a positive effect on overall survival for patients with recurrent glioblastoma, there is growing excitement for our Controlled IL-12 platform among treating physicians."

David Mauney, M.D., President of Ziopharm, added, "We have significant momentum following our transformational fourth quarter 2018 when we established a new license agreement that provides us with clinical development autonomy. We secured two new business development deals and strengthened our balance sheet by eliminating $157 million in preferred stock and raising $50 million in a private placement. Thus, we are now well positioned to achieve multiple milestones and to be in the clinic in 2019 with each of our pillar programs: TCR-T, CAR-T and Controlled IL-12."

Program Updates

Sleeping Beauty TCR-T Therapies

The Company is using its Sleeping Beauty platform to develop a personalized T-cell therapy targeting solid tumors with T-cell receptors or TCRs. Under a Cooperative Research and Development Agreement (CRADA), the NCI is expected to initiate a Phase 1 clinical trial to treat patients who may have one of a variety of solid tumors using the Sleeping Beauty platform to genetically modify T-cells to target patient-specific neoantigens.

Phase 1 trial for TCR-T cell therapy expected to begin in mid-2019: This trial is on track to begin treating patients in mid-2019 under the direction of Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI.

CRADA extended: Ziopharm announces that the Company and the NCI agreed to extend the CRADA governing this program to evaluate genetically modified T cells targeting solid tumors, which was established in January 2017. This agreement has been extended through January 2022.

Sleeping Beauty CAR-T Therapies

Ziopharm is advancing the Sleeping Beauty platform towards the very rapid manufacturing of genetically modified CAR+ T cells, co-expressing membrane-bound interleukin-15, or mbIL15, with a safety switch, within two days after genetically modifying T cells from the patient. This work is being done in collaboration with the University of Texas MD Anderson Cancer Center in the United States and will be done in Greater China through a joint venture, Eden BioCell.

Third-generation Phase 1 trial for very rapid manufacturing of Sleeping Beauty CD19-specific CAR-T with mbIL15 expected to begin 2H2019: The Company affirms guidance on beginning this trial and treating patients at MD Anderson Cancer Center in the second half of this year. Ziopharm announced in June 2018 that the FDA placed this investigator-led IND on clinical hold and requested additional information relating to chemistry, manufacturing and controls, specifically requesting that the product meet a minimum threshold for T-cell viability. The Company, in partnership with MD Anderson Cancer Center, has made progress toward achieving this threshold in manufacturing through improved engineering and cell processing.

Eden BioCell to advance third-generation Sleeping Beauty CAR-T for Greater China: In December 2018, Ziopharm in conjunction with TriArm Therapeutics announced Eden BioCell will be launched to develop and commercialize Sleeping Beauty-generated CD19-specific CAR-T therapies in the People’s Republic of China (including Macau and Hong Kong), Taiwan and Korea. The teams have begun meeting to prepare for technology transfer and launch the new company. Ziopharm and TriArm each will own 50 percent of the

joint venture. Eden BioCell will be funded with up to $35 million from TriArm, a privately-owned cell therapy company that was formed by Panacea Venture Healthcare, a fund co-founded and managed by James Huang, Managing Partner of Kleiner Perkins Caufield & Byers China. Ziopharm and TriArm expect to close on this joint venture in the first half of 2019. Ziopharm’s CEO Laurence Cooper, and Panacea Venture Healthcare co-founder James Huang will serve on Eden BioCell’s Board of Directors with each party sharing decision-making authority. Ziopharm looks forward to providing an update on clinical development plans for Eden BioCell later in the year.

Controlled IL-12

Ziopharm is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, as a drug to control the production of human interleukin 12 (hIL-12) which activates the immune system to recruit cancer-fighting T cells into tumors. In the setting for the treatment of recurrent glioblastoma (rGBM), Ziopharm is advancing Ad-RTS-hIL-12 plus veledimex as a monotherapy and in combination with immune checkpoint inhibitors.

Enrollment completed in Phase 1 monotherapy expansion substudy: Ziopharm announced that it rapidly completed enrollment and treated a total of 36 patients in less than six months in a substudy to expand a Phase 1 trial evaluating its Controlled IL-12 platform as a monotherapy for the treatment of rGBM. The trial was over enrolled by eleven patients more than the target goal of 25, which the Company attributes to enthusiasm stemming from encouraging survival and tumor biopsy data. Preliminary data from this substudy is expected to be presented in 2019.

Third cohort has begun in combination substudy with OPDIVO (nivolumab): Ziopharm reported that it has completed two dosing cohorts in its Phase 1 substudy of adult patients with rGBM to evaluate a single dose of Ad-RTS-hIL-12 plus daily veledimex in combination with OPDIVO (nivolumab), an immune checkpoint inhibitor targeting programmed death-1 (PD-1). The Company has begun the third cohort for this study to evaluate the safety and tolerability of this combination regimen, establish optimal dosing of veledimex and nivolumab, and measure overall patient survival. The Company expects to complete enrollment in the third cohort in the second quarter this year and looks forward to presenting preliminary data from this trial in 2019.

Phase 2 combination trial with Regeneron’s Libtayo (cemiplimab-rwlc) expected to open 2Q2019: The Company, in collaboration with Regeneron Pharmaceuticals, expects to open a Phase 2 trial to evaluate Ad-RTS-hIL-12 plus veledimex in combination with Regeneron’s PD-1 antibody Libtayo (cemiplimab-rwlc) for treating patients with rGBM. The Company expects to enroll approximately 30 patients in this trial.

Phase 1 for pediatric tumors ongoing: Ziopharm is enrolling pediatric patients in its Phase 1 trial of Ad-RTS-hIL-12 with veledimex for the treatment of brain tumors at multiple U.S. sites.

Corporate Update

In addition to the clinical collaboration with Regeneron and the execution of an agreement to launch Eden BioCell during the fourth quarter of last year, Ziopharm on October 9, 2018, announced that it entered into a new licensing agreement that replaced all existing agreements with Intrexon Corp. and its subsidiary Precigen, Inc. Under the new license agreement, Ziopharm has full developmental control and exclusivity utilizing Sleeping Beauty for TCRs for the treatment of cancer. The CRADA with the NCI related to Sleeping Beauty-generated T cells expressing TCRs to target neoantigens within solid tumors was transferred to Ziopharm and the Company will maintain this program. Ziopharm will build on its Controlled IL-12 platform with exclusive access to Precigen’s RheoSwitch Therapeutic System gene switch with adenovirus for the treatment of cancer. Using the Sleeping Beauty system, Ziopharm will continue to exclusively advance its CD19-specific chimeric antigen receptor (CAR) program leveraging membrane-bound interleukin 15, while retaining rights to a second, unnamed CAR target. Ziopharm has sole oversight for the relationship with MD Anderson Cancer Center, the Company’s initial development partner for the Sleeping Beauty platform.

As part of the new licensing agreement, Ziopharm successfully negotiated the complete elimination of preferred stock that had been issued to Intrexon that was valued at approximately $157 million at that time.

In December, David Mauney, M.D., was promoted to President. Dr. Mauney had joined the Company in September 2017 as Executive Vice President and Chief Business Officer.

Fourth-Quarter 2018 Financial Results

Net income (loss) applicable to the common shareholders for the fourth quarter of 2018 was $194.5 million, or $1.29 per share, basic and diluted, compared to a net loss of $18.3 million, or $(0.13) per share, basic and diluted, for the fourth quarter of 2017. The increased income attributable to common shareholders resulted primarily from the forfeiture and return of all of the Company’s Series 1 preferred stock held by Intrexon Corporation and the relinquishment of Ziopharm’s obligations under the Ares Trading Agreement.

Research and development expenses were $8.2 million for the fourth quarter of 2018, compared to $11.2 million for the fourth quarter of 2017. The decrease in research and development expenses for the three months ended Dec. 31, 2018 is primarily due to decreased preclinical activity related to our cell and gene therapy programs.

General and administrative expenses were $4.6 million for the fourth quarter of 2018, compared to $3.9 million for the fourth quarter of 2017. The increase in general and administrative expenses for the three months ended Dec. 31, 2018 is primarily due to contracted outside service costs.

Full Year 2018 Financial Results

Net income (loss) applicable to the common shareholders for the year ended December 31, 2018 was $137.2 million, or $0.96 per share, basic and diluted, compared to a net loss applicable to the common shareholders of $73.3 million, or $(0.53) per share, basic and diluted, for the year ended December 31, 2017. The increased income attributable to common shareholders resulted primarily from the forfeiture and return of all of the Company’s Series 1 preferred stock held by Intrexon Corporation and the relinquishment of Ziopharm’s obligations under the Ares Trading Agreement.

Research and development expenses were $34.1 million for the year ended December 31, 2018, compared to $45.1 million for the year ended December 31, 2017. The decrease in research and development expenses for the year ended December 31, 2018, is primarily due to decreased preclinical activity related to our cell and gene therapy programs.

General and administrative expenses were $19.9 million for the year ended December 31, 2018, compared to $14.8 million for the Year ended December 31, 2017. The increase in general and administrative expenses for the year ended December 31, 2018, is primarily due to contracted outside service costs.

The Company ended the year with unrestricted cash resources of approximately $61.7 million.

In addition, a prepayment of approximately $27.8 million remains for programs to be conducted by the Company at MD Anderson Cancer Center under the current Research and Development Agreement.

The Company believes its current resources will be sufficient to fund its currently planned operations into the second quarter of 2020.

The 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 3091306. To access the slides and live webcast or the subsequent archived recording, visit the "Investors & Media" 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 March 5, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO) reported that Bill Newell, Chief Executive Officer, will present at the Cowen and Company 39th Annual Health Care Conference on Monday, March 11 at 2:50 p.m. ET at the Marriott Copley Place in Boston (Press release, Sutro Biopharma, MAR 5, 2019, View Source [SID1234533981]).

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A live webcast of the presentation will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.sutrobio.com. A replay of the webcast will be available for approximately 30 days following the event.

On March 5, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will present at the upcoming Barclays Global Healthcare Conference taking place March 12-14, 2019 in Miami Beach, Florida (Press release, Zymeworks, MAR 5, 2019, View Source [SID1234533980]).

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                  Schedule Your 30 min Free Demo!

The Company’s presentation will be on March 12, 2018 at 9:00 a.m. ET.

Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website at View Source, which will also host a recorded replay available afterwards.