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ExCellThera enters into a manufacturing and collaboration agreement with New York Blood Center

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.

Dova Pharmaceuticals Reports First Quarter 2019 Operating and Financial Results

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]).

"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

CytomX Therapeutics to Present at the Bank of America Merrill Lynch 2019 Health Care Conference

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.

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.

Curis to Release First Quarter Financial Results and Hold Conference Call on May 14, 2019

On May 7, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its first quarter financial results on Tuesday, May 14, 2019, after the close of US markets (Press release, Curis, MAY 7, 2019, View Source [SID1234535822]). Management will host a conference call on the same day at 4:30 p.m. ET.

To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

Cerus Corporation Announces Record First Quarter 2019 Results

On May 7, 2019 Cerus Corporation (Nasdaq: CERS) reported financial results for the first quarter ended March 31, 2019 (Press release, Cerus, MAY 7, 2019, View Source [SID1234535821]).

Recent developments and highlights include:

Total first quarter revenue of $22.0 million
Record quarterly product revenue of $17.5 million, a 29% increase compared to the prior year quarter
Government contract revenue of $4.5 million
Worldwide disposable kit demand increased 35% from the prior year quarter
2019 full year product revenue guidance being raised to range of $71 million to $74 million from $70 million to $73 million
Regulatory feedback on INTERCEPT red cell CE Mark submission will add to the overall review period
Strengthened balance sheet with a $90 million new debt facility consisting of a staged $70 million term loan and a $5 million revolving line of credit, expandable up to $20 million
"Our first quarter results reflect the continued strong underlying demand by blood centers and hospitals for INTERCEPT treated components which provides lower risk of transfusion transmitted infections from both known and emerging pathogens," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "The robust sales momentum we experienced in 2018 has extended into 2019 driven by further U.S. adoption in advance of an expected FDA final guidance document on bacterial risk control strategies for platelet collection and transfusion this year."

"We are continuing to progress our development programs and to enhance our capabilities surrounding quality, manufacturing and supply chain continuity. In Europe, recent discussions with our Notified Body for the INTERCEPT red blood cell CE Mark submission have provided us with additional information which we expect, however, will extend the review process. We are using this opportunity to take measures to enhance our supply chain security prior to the anticipated commercial launch," continued Greenman.

Revenue

Product revenue during the first quarter of 2019 was $17.5 million, compared to $13.6 million during the same period in 2018. Revenue growth in the quarter benefited from the volume growth in disposable kit sales in the U.S., and increased disposable kit sales in the Middle East, partially offset by product mix in France and the strengthening of the U.S. dollar relative to the Euro.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $4.5 million during the first quarter of 2019, compared to $3.5 million during the same period in 2018, as a result of increasing INTERCEPT red blood cell clinical and development activities. The total potential value of the current BARDA agreement is $201 million with $29 million recognized as revenue to date.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the first quarter of 2019 were 52%, compared to 46% for the first quarter of 2018. Gross margins in the quarter benefited from economies of scale and lower pricing from our contract manufacturer, favorable product mix in France and overall increased demand for platelet kits.

Operating Expenses

Total operating expenses for the first quarter 2019 were $29.6 million compared to $23.0 million for the same period the prior year.

Selling, general, and administrative (SG&A) expenses for the first quarter of 2019 totaled $16.2 million, compared to $13.6 million for the first quarter of 2018. The year-over-year increase was primarily tied to investments in our manufacturing and supply chain capabilities. This focus and investment is consistent with our plan that is designed to ensure stability of supply, improved management of our supply chain and preparation for planned global growth of demand for our products.

Research and development (R&D) expenses for the first quarter of 2019 were $13.4 million, compared to $9.4 million for the first quarter of 2018. The increase in year-over-year R&D expenses was primarily due to additional activities and costs tied to the development of INTERCEPT red blood cell system and activities related to the BARDA agreement.

Net Loss

Net loss for the first quarter of 2019 was $18.8 million, or $0.14 per diluted share, compared to a net loss of $13.9 million, or $0.11 per diluted share, for the first quarter of 2018.

Cash, Cash Equivalents and Investments

At March 31, 2019, the Company had cash, cash equivalents and short-term investments of $100.4 million, compared to $117.6 million at December 31, 2018.

At March 31, 2019, the Company had approximately $39.4 million in outstanding term loan debt compared to $29.9 million at December 31, 2018.

Revised 2019 Product Revenue Guidance

The Company currently expects 2019 product revenue to be in the range of $71 million to $74 million compared to our previous guidance range of $70 million to $73 million. The new guidance range represents 17% to 21% growth compared to 2018 reported product revenue.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 3932269. The replay will be available approximately three hours after the call through May 21, 2019.