On May 7, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported financial results for the first quarter ended March 31, 2019 and provided an update on recent corporate activities (Press release, Halozyme, MAY 7, 2019, View Source [SID1234535828]).

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"We enjoyed a strong start to 2019 as our first quarter included a new ENHANZE collaboration with argenx, positive phase III data from Janssen’s COLUMBA study evaluating a subcutaneous formulation of DARZALEX, and FDA approval of Herceptin Hylecta," said Dr. Helen Torley, president and chief executive officer. "Looking ahead in 2019, we expect this momentum to continue. On ENHANZE we anticipate regulatory submissions by ENHANZE partner Janssen for the subcutaneous formulation of DARZALEX, a new phase 3 trial initiation by one of our ENHANZE partners and multiple Phase 1 trial initiations. On PEGPH20, we project the announcement of topline results from our HALO-301 pivotal phase 3 trial in pancreas cancer in the second half of the year."

First Quarter 2019 and Recent Highlights Include:

In February 2019, we announced that Genentech, a member of the Roche Group, received approval from the FDA for Herceptin Hylecta, a co-formulation of trastuzumab and rHuPH20. Herceptin Hylecta is approved for the treatment of certain people with HER2-positive early breast cancer. Herceptin Hylecta is a ready-to-use formulation that can be administered in two to five minutes, compared to 30 to 90 minutes for intravenous trastuzumab. In April 2019, Roche made Herceptin Hylecta available in the U.S.

In February 2019, Janssen’s development partner, Genmab, announced positive Phase 3 trial results from the COLUMBA study. The study evaluated subcutaneous DARZALEX in comparison to DARZALEX IV in patients with relapsed and refractory multiple myeloma. DARZALEX SC, using ENHANZE drug delivery technology, was found to be non-inferior to DARZALEX IV with regard the co-primary endpoints of Overall Response Rate and Maximum Trough concentration on day 1 of the third treatment cycle. Additional data from this trial will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago at an oral presentation on Sunday, June 2, 2019.

In February 2019, we entered into a collaboration agreement with argenx for the right to develop and commercialize one exclusive target, the human neonatal Fc receptor FcRn, which includes argenx’s lead asset efgartigimod (ARGX-113), and an option to select two additional targets using our ENHANZE technology for an upfront payment of $30.0 million. We will receive payments of $10.0 million per target for future target nominations and potential milestone payments of up to $160.0 million per target, subject to the achievement of specific development, regulatory and sales-based milestones. We will receive mid-single digit royalties on sales of commercialized products.

With regard to HALO-301, a Phase 3 study evaluating PEGPH20 in metastatic pancreas cancer, the company now expects to achieve the target number of overall survival (OS) events in the third quarter of 2019. The company plans to initiate the database lock process for final analysis after 330 OS events have been achieved with mature data. As a result, the company expects topline results will be available in the second half of 2019.

First Quarter 2019 Financial Highlights

Revenue for the first quarter was $56.9 million compared to $30.9 million for the first quarter of 2018. The year-over-year increase was primarily driven by $30.0 million in upfront license fees for the argenx collaboration. Revenue for the quarter included $18.0 million in royalties and $8.4 million in product sales, which compared to $20.9 million and $6.8 million, respectively, in the prior year period. The decrease in royalties was mainly driven by lower sales of Herceptin SC by Roche, partially offset by higher sales of RITUXAN HYCELA in the U.S. by Roche.

Research and development expenses for the first quarter were $31.3 million, compared to $38.0 million for the first quarter of 2018. The decline in expenses was driven by reduced clinical trial activity due to the completion of enrollment in HALO-301.

Selling, general and administrative expenses for the first quarter were $18.0 million, compared to $13.6 million for the first quarter of 2018. The increase is related to an increase in personnel expenses, including stock based compensation as well as preparations for the potential commercial launch of PEGPH20.

Net income for the first quarter was $1.8 million, or $0.01 per share, compared to a net loss in the first quarter of 2018 of $27.5 million, or $0.19 per share.

Cash, cash equivalents and marketable securities were $328.7 million at March 31, 2019, compared to $354.5 million at December 31, 2018.

Financial Outlook for 2019

Halozyme reiterates its overall 2019 financial guidance while lowering the anticipated contribution from royalties and increasing the anticipated contribution from products sales related to API. For 2019, Halozyme now expects:

Net revenue of $205 million to $215 million;
–
Revenue from royalties of $72 million to $74 million, with the decrease primarily attributable to the ongoing impact from biosimilars in Europe and updated expectations for the US launched products;
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Product sales related to API increased to reflect additional customer orders;

Operating expenses of $265 million to $275 million, or $225 million to $235 million excluding an expected increase in cost of goods sold;

Operating cash burn of $45 million to $55 million;

Debt repayment of approximately $90 million, the company expects to pay off the remainder of the royalty-backed debt by the end of the first quarter of 2020;

Year-end cash, cash equivalents and marketable securities balance of $210 million to $220 million.

This guidance continues to exclude revenue from any potential, new ENHANZE global collaboration and licensing agreements.

Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the first quarter of 2019 today, Tuesday, May 7, 2019 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (866) 393-4306 (domestic callers) or (734) 385-2616 (international callers). A telephone replay will be available after the call by dialing (855) 859-2056 (domestic callers) or (404) 537-3406 (international callers) using replay ID number 3076769.

On May 7, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported business highlights and financial results for the first quarter ended March 31, 2019 (Press release, Fate Therapeutics, MAY 7, 2019, View Source [SID1234535827]).

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"These past several months have been particularly inspiring for the Company, as we have delivered on our multi-year journey to be the first to bring iPSC-derived cell products to patients with cancer. We believe the ability to cost-effectively mass-produce cell-based cancer immunotherapies that can be safely delivered to patients ‘on demand’ in multiple doses has the potential to transform outcomes for many patients, especially when combined with therapeutic agents that have complementary mechanisms of action such as checkpoint inhibitors and monoclonal antibodies," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We are very encouraged by the initial observations of safety and tolerability from the three patients who received multiple doses of FT500 in the first dose cohort, and we are excited with the initiation of the multi-dose checkpoint inhibitor combination arm where patients have previously progressed or failed therapy. In addition, we continue to make tremendous progress in advancing additional candidates from our off-the-shelf, iPSC-derived NK cell and T-cell product pipeline toward the clinic, and we look forward to generating initial clinical data with FT516 and FT596 in 2019."

Clinical Programs

Landmark Clinical Trial of iPSC-derived Cell Product FT500 Clears Key Safety Hurdle. Three patients with advanced solid tumors have been treated with multiple doses of FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line, at the first dose level of 100 million cells per dose in the study’s monotherapy arm. All three patients received three once-weekly doses of FT500 in an outpatient setting in the first treatment cycle, which was well-tolerated with no dose-limiting toxicities or serious adverse events reported during the initial 28-day observation period. In accordance with the clinical protocol, all three patients advanced to a second, multi-dose treatment cycle of FT500, which has also been well-tolerated with no dose-limiting toxicities or serious adverse events reported to date. As a result of clearing the first safety hurdle, the Company has commenced patient enrollment at the second dose level of 300 million cells per dose.
FT500 Study Opened for Enrollment in Checkpoint Inhibitor Combination Arm. In April, the Company opened enrollment in the checkpoint inhibitor combination arm of the FT500 clinical trial for the treatment of advanced solid tumors. Multiple doses of FT500 will be administered in combination with either nivolumab, pembrolizumab or atezolizumab in patients whose tumors failed to respond (primary resistance), or progressed following initial response (acquired resistance), with the prior checkpoint inhibitor therapy.
Showcased GMP Manufacturing Data for FT500 Production at ASGCT (Free ASGCT Whitepaper). At the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 22nd Annual Meeting in April, the Company demonstrated its unmatched ability for cGMP mass production of cell-based cancer immunotherapies for off-the-shelf use. Starting with a single cryopreserved vial from the FT500 master iPSC bank, hundreds of cryopreserved doses of FT500 were produced in a single manufacturing campaign at a low cost per dose. The cryopreserved FT500 cell product met stringent post-thaw release specifications, including identity (100% CD45+ hematopoietic cells), purity (98% CD45+CD56+ NK cells), viability and potency, to support shipment to participating clinical sites. FT500 exhibits high levels of expression of key activating receptors (including NKG2D and NKp30/40/46), low levels of expression of checkpoint receptors (including PD-1, LAG-3 and TIGIT), and secretes high levels of cytolytic proteins (such as perforin and granzyme B) in response to challenge with cancer cell lines.
Expanded Enrollment of Phase 2 PROTECT Study of ProTmune to 80 Patients. The randomized, controlled and double-blind Phase 2 PROTECT study has enrolled over 55 patients undergoing allogeneic hematopoietic cell transplant for the treatment of hematologic malignancies. While remaining blinded, the Company has elected to increase the size of the PROTECT study to 80 patients based on strong investigator interest and with the intent to potentially seek regulatory approval of ProTmune using data from the study. The Company expects to complete enrollment of the PROTECT study in 2019 as planned, with data available in 2020 on the study’s primary and secondary endpoints.
Universal, Off-the-Shelf NK and T-cell Cancer Immunotherapy Preclinical Pipeline

Received FDA Clearance of IND Application for First-ever Engineered iPSC-derived Cell Product FT516. In February 2019, the Company announced that the FDA allowed its IND application for FT516, a universal, off-the-shelf NK cell product candidate derived from a clonal master iPSC line engineered to express a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor. FT516 is the first-ever cell product derived from a genetically engineered pluripotent stem cell to be cleared for clinical testing worldwide. A cGMP production run for FT516 has been completed, and final product release testing is ongoing. The Company intends to clinically investigate FT516 for the treatment of relapsed / refractory hematologic malignancies including in combination with certain FDA-approved monoclonal antibody therapies.
Generated Clonal Master Engineered iPSC Bank for FT596 Dual Antigen-targeted CAR NK Cell. FT596 is the Company’s universal, off-the-shelf chimeric antigen receptor (CAR) NK cell product candidate that expresses a proprietary CD19-targeted CAR, a novel hnCD16 Fc receptor for augmented antibody-dependent cellular cytotoxicity (ADCC) and a unique IL-15 receptor fusion for enhanced NK cell activity. The FT596 clonal master iPSC bank was derived from a single iPSC, which was specifically selected based on a series of critical attributes including characterization of the genomic integration sites of the engineered elements, confirmation of genomic stability, demonstration of highly efficient and reproducible production of the product candidate, and robust post-cryopreservation viability and multi-purpose functional activity of the product candidate. The Company expects to submit an IND application to the FDA in mid-2019 for clinical investigation of FT596.
Corporate Highlights

Expanded Board of Directors. In March 2019, the Company appointed Karin Jooss, Ph.D. to its Board of Directors. Dr. Jooss has more than 20 years of experience in oncology and immunology research and development and is currently the Executive Vice President of Research and Chief Scientific Officer of Gritstone Oncology, Inc., a clinical-stage biotechnology company developing next-generation cancer immunotherapies targeting tumor-specific neoantigens.
Expanded Clinical Development and Translation Leadership Team.Sarah Cooley, M.D., M.S. joined the Company in February 2019 as Senior Vice President, Clinical Translation, and Yu-Waye (Wayne) Chu, M.D. joined the Company in April 2019 as Vice President, Clinical Development. Dr. Cooley brings to Fate Therapeutics more than 12 years of leadership in the field of NK cell clinical research and development, having most recently served as Associate Professor of Medicine in the Division of Hematology, Oncology and Transplantation at the University of Minnesota. Dr. Chu brings extensive experience in the development of cancer immunotherapies from Genentech, where he most recently served in Product Development Oncology as global development leader of mosunetuzumab, a full-length T cell-dependent bispecific CD20/CD3 antibody.
First Quarter 2019 Financial Results

Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of March 31, 2019 were $183.0 million, compared to $201.0 million as of December 31, 2018. The decrease was primarily driven by the Company’s use of cash to fund operating activities.
Total Revenue: Revenue was $2.6 million for the first quarter of 2019, compared to $1.0 million for the same period in 2018. Revenue was derived from the Company’s collaborations with Ono Pharmaceutical and Juno Therapeutics.
R&D Expenses: Research and development expenses were $17.7 million for the first quarter of 2019, compared to $11.5 million for the same period in 2018. The increase in R&D expenses was primarily attributable to an increase in expenses associated with the preclinical and clinical development of the Company’s product pipeline and in employee compensation, including share-based compensation, associated with growth in headcount.
G&A Expenses: General and administrative expenses were $5.4 million for the first quarter of 2019, compared to $3.6 million for the same period in 2018. The increase in G&A expenses was primarily attributable to an increase in employee compensation, including share-based compensation.
Shares Outstanding: Common shares outstanding were 65.1 million as of March 31, 2019 and 64.7 million as of December 31, 2018. Preferred shares outstanding as of March 31, 2019 and December 31, 2018 were 2.8 million, each of which is convertible into five shares of common stock.
Today’s Conference Call and Webcast
The Company will conduct a conference call today, Tuesday, May 7, 2019 at 5:00 p.m. ET to review financial and operating results for the quarter ended March 31, 2019. In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 6444079. The live webcast can be accessed under "Events & Presentations" in the Investors & Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf to treat many patients. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is fraught with batch-to-batch and cell-to-cell variability that can affect safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.

About FT500
FT500 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line. Despite the clinical benefit conferred by approved checkpoint inhibitor therapy against a variety of tumor types, these therapies are not curative and, in most cases, patients either fail to respond or progress on these agents. One common mechanism of resistance to checkpoint inhibitor therapy is associated with loss-of-function mutations in genes critical for antigen presentation. A potential strategy to overcome resistance is through the administration of allogeneic NK cells, which have the inherent capability to recognize and directly kill tumor cells with these mutations. FT500 is being investigated in an open-label, multi-dose Phase 1 clinical trial for the treatment of advanced solid tumors (clinicaltrials.gov ID number NCT03841110). The study is designed to assess the safety and activity of three once-weekly doses of FT500 as a monotherapy and in combination with one of three FDA-approved checkpoint inhibitor therapies – nivolumab, pembrolizumab or atezolizumab – in patients that have failed prior checkpoint inhibitor therapy. Patients who are clinically stable following the first cycle of FT500 treatment are eligible to receive a second treatment cycle of three additional once-weekly doses of FT500.

About FT516
FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity (158V), non-cleavable CD16 (hnCD16) Fc receptor. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. CD16 occurs in two variants, either with high (158V) or low (158F) affinity for the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the CD16 high-affinity variant (approximately 15% of patients) have improved clinical outcomes. In addition, ADCC is dependent on NK cells maintaining active levels of CD16 expression, and the expression of CD16 on NK cells has been shown to undergo considerable down-regulation in cancer patients, which can significantly inhibit anti-tumor activity. FT516 incorporates a novel CD16 Fc receptor, which has been modified to prevent its down-regulation and augment its binding to tumor-targeting antibodies for enhanced ADCC.

About ProTmune
ProTmune is an investigational, first-in-class, allogeneic hematopoietic cell graft for the prevention of acute graft-versus-host disease (GvHD) in patients undergoing hematopoietic cell transplantation (HCT) for the treatment of hematologic malignancies. ProTmune is manufactured by pharmacologically modulating a donor-sourced, mobilized peripheral blood graft ex vivo with two small molecules (FT1050 and FT4145) to decrease the incidence and severity of acute GvHD while maintaining the anti-leukemia activity of the graft. ProTmune has been granted Orphan Drug and Fast Track Designations by the U.S. Food and Drug Administration, and Orphan Medicinal Product Designation by the European Commission. ProTmune is currently being investigated in a randomized, controlled and double-blind Phase 2 clinical trial in adult subjects with hematologic malignancies undergoing matched unrelated donor HCT.

On May 7, 2019 ExCellThera Inc., an advanced clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, reported that it has entered into a manufacturing and collaboration agreement with Comprehensive Cell Solutions (CCS), a division of New York Blood Center (NYBC) for the clinical grade production of ExCellThera’s lead cell therapy product, ECT-001 (Press release, ExCellThera, MAY 7, 2019, View Source [SID1234535826]).

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The agreement provides ExCellThera access to New York Blood Center’s cGMP clean room manufacturing facilities in New York for the production of ECT-001, to be used in clinical trials principally in the United States. ExCellThera’s near term pipeline includes several ongoing studies and additional trials using ECT-001 to be initiated in the coming months.

"The New York Blood Center holds one of the world’s largest blood banks and has over 50 years of leadership in research and development, medical services and laboratory services. We are extremely pleased to enter into this multi-year agreement which will allow us to work closer together and leverage their leadership and expertise in this specialized field," said David Millette, Chief Operating and Financial Officer at ExCellThera. "ExCellThera expects a substantial scale-up in production to meet the needs of new trials coming online as ECT-001 advances through the final phases of its clinical development. This collaboration with NYBC will increase overall production capabilities by adding capacity to the existing manufacturing facilities in Montreal, Canada, while also providing redundancies, easing cross-border issues and providing further strategic collaboration opportunities."

"We are proud to partner with ExCellThera as they work to create groundbreaking curative treatments for patients suffering from blood diseases. Their work has the potential to dramatically increase access to stem cells for patients who need them and unleash the therapeutic promise of the hundreds of thousands of cord blood units stored worldwide," said Chief Medical and Scientific Officer at New York Blood Center, Dr. Beth H. Shaz. "New York Blood Center is the perfect fit for this endeavor. With its facilities, in the heart of the city’s life sciences corridor, NYBC can collaborate with leading international biotechnology companies doing critical work to advance medical research. As the creators of the world’s first and largest public cord bank, we’re excited about the opportunity to leverage our experience to support such an important mission."

The ECT-001 technology is a combination of a small molecule, UM171, and an optimized culture system. The technology, capable of expanding the number of stem and immune cells exponentially in as little as seven days, is used in novel curative blood transplant therapies for patients with blood malignancies and other diseases, allowing more rapid engraftment, greatly reduced incidence of transplant-related mortality, low risk of chronic graft-versus-host disease and low risk of relapse, resulting in better outcomes for patients. The FDA has granted ECT-001 orphan drug designation for the prevention of graft-versus-host disease and regenerative medicine advanced therapy designation in the treatment of hematologic malignancies.

The agreement also provides further strategic collaboration between the parties, including opportunities to explore additional avenues to work together in pursuit of a common goal of improving transplantation protocol and the livelihood of patients.

On May 7, 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 first quarter ended March 31, 2019 (Press release, Dova Pharmaceuticals, MAY 7, 2019, View Source [SID1234535824]).

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"Since refining our commercial strategy in December, we have become increasingly confident in the potential opportunities for DOPTELET as a treatment for thrombocytopenia. We are also encouraged by the initial feedback on our revised marketing and sales activities, which we expect to drive DOPTELET sales," said Dr. David Zaccardelli, President and Chief Executive Officer of Dova. "In addition, we have made significant progress in our commercial preparation for the potential FDA approval of DOPTELET for the treatment of chronic ITP. With experienced clinical and commercial teams and a strong cash position, Dova remains well positioned to bring DOPTELET to patients across multiple indications."

DOPTELET Launch Highlights

Net product sales for DOPTELET were $4.0 million for the first quarter, an increase of 43% from the fourth quarter of 2018.

The US sales team was restructured in early January 2019. It is now comprised of 44 sales territories and 5 regional directors responsible for driving DOPTELET sales in the hepatology, hematology, and interventional radiology physician segments.

Co-promotion partner, Salix, with approximately 100 sales representatives, is responsible for driving DOPTELET sales for gastroenterology, colorectal surgery and proctology practices, and continues to progress as an integrated approach to expand our prescriber base.

Early in the second quarter, a new marketing strategy was launched, including revised product positioning, messaging and a new action-oriented brand campaign.

From launch through March 31, 2019, a total of 1,060 health care professionals have prescribed DOPTELET to their patients, with an increasing number of repeat prescribers.

More than 13,000 calls were conducted, reaching more than 6,500 unique health care providers during the first quarter of 2019.

For prescriptions in the first quarter that have gone through the adjudication process with payers, 82% of those prescriptions were approved. On average, the time to decision for a referral was 6.3 business days in the quarter.

Inventory held by specialty pharmacies in Dova’s contracted network remained relatively constant from January 1, 2019 to March 31, 2019.

Additional First Quarter Highlights

DOPTELET sNDA – under review by the U.S. Food and Drug Administration (FDA) for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is June 30, 2019. Sales professionals with hematology/oncology experience, with a focus on ITP, are being recruited to the sales force in anticipation of a potential U.S. launch.

DOPTELET MAA – received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for DOPTELET for the treatment of severe thrombocytopenia in adult patients with CLD who are scheduled to undergo an invasive procedure. A European Commission decision for the MAA is expected in the third quarter of 2019.

Phase 3 CIT Clinical Trial – continues to enroll patients for the treatment of chemotherapy-induced thrombocytopenia (CIT); plan reporting of primary and select secondary results in the first half of 2020.

First Quarter Financial Results

Net product sales for DOPTELET were $4.0 million for the first quarter of 2019. The Company recognizes revenue when products are delivered to its specialty pharmacy partners.

Dova reported a net loss of $16.4 million for the first quarter of 2019, compared to a net loss of $13.8 million for the same period in 2018.

Cost of product sales for the first quarter were $0.5 million, which consisted of the cost of inventory, royalty payments due to Astellas and certain distribution and overhead costs.

Research and development expenses were $4.1 million in the first quarter of 2019, compared to $3.4 million for the same period in 2018. The increase was primarily due to the ongoing clinical trial to evaluate DOPTELET for the treatment of CIT.

Selling, general and administrative expenses were $15.8 million in the first quarter of 2019, compared to $10.3 million for the same period in 2018. 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.

As of March 31, 2019, Dova had $92.7 million in cash and equivalents compared to $104.6 million as of December 31, 2018. Additionally, on May 6, 2019, Dova entered into an amended and restated loan agreement with Silicon Valley Bank that extends the interest only period of the existing $20 million loan facility by 12 months and provides additional potential borrowings of $30 million upon achieving certain clinical and revenue milestones.

Company to Host Conference Call

Dova will host a conference call today, May 7, 2019 at 9:00 a.m. ET to discuss first quarter ended March 31, 2019 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 9551427 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 May 7, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on our Probody therapeutic technology platform, reported that the company will present at the Bank of America Merrill Lynch 2019 Health Care Conference (Press release, CytomX Therapeutics, MAY 7, 2019, View Source [SID1234535823]). Sean McCarthy, D.Phil., president, chief executive officer and chairman, will deliver a corporate overview on May 16, 2019, at 10:15 a.m. PDT/ 1:15 p.m. EDT.

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A live audio webcast of the presentation will be available through the Investors and News section of CytomX’s website. An archived replay will be available for 90 days following the event.