On August 9, 2018 Turnstone Biologics, a clinical-stage immuno-oncology company developing the next generation of oncolytic viral therapies, reported its presentation at the upcoming investor conference (Press release, Turnstone Biologics, AUG 9, 2018, View Source [SID1234528598]):

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2018 Wedbush PacGrow Healthcare Conference
Date: Tuesday, August 14, 2018
Time: 3:05 p.m. ET
Presenter: Sammy Farah, Ph.D., President and Chief Executive Officer

On August 9, 2018 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, reported financial results for the second quarter of 2018 (Press release, Agenus, AUG 9, 2018, View Source [SID1234528647]).

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"Innovation and speed are core to our strategy. We have delivered eight new discoveries over the past 2 years. This year alone, 3 INDs from our discovery engines have been filed and 3 additional INDs will be filed by year end; they include our NexGen CTLA-4 and our first-in-class bispecifics. We have delivered on our partnership commitments with Merck and Incyte with 2 programs in the clinic this year and a third expected before the end of the year, each triggering a cash milestone," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "In addition, our proprietary CTLA-4 and PD-1 programs are advancing in three trials designed to take advantage of accelerated pathways for a BLA filing as early as 2020. Our partnership discussions have advanced towards potential closure. With these developments, we expect to deliver value to our shareholders and partners."

Key clinical and business updates

Operational Achievements:
New discoveries advance to clinic
Three INDs filed and 3 more to be filed by the end of 2018, including Next-Gen CTLA-4 and two first-in-class bispecifics
Lead CTLA-4 (AGEN1884) & PD-1 (AGEN2034) trials advance towards BLA as early as 2020
ASCO reported data show 31-42% benefit
New data in 2018 anticipated to show expanded benefit
Three trials ongoing designed to leverage accelerated pathways
Payment milestones triggered in partnerships with Incyte, Merck
LAG-3 (INCAGN02385) in the clinic
TIM-3 (INCAGN02390) expected to enter clinic in 2018
Undisclosed target with Merck entered clinic
Sales of GSK’s Shingrix, containing QS-21 Stimulon, have exceeded projections
Manufacturing Speed and Innovation:
Completed clinical & pivotal grade material for AGEN1884 & AGEN2034 3-5x faster than industry standards
First-in-class bispecific, AGEN1223, manufactured at scale in <2 months; setting industry records
AgenTus Cell Therapy Business:
Lead identified for IND filing; private financing and plans for IPO underway
Second Quarter 2018 Financial Results

Cash and cash equivalents were $43.2 million and $60.2 million at June 30, 2018 and December 31, 2017 respectively.

For the second quarter ended June 30, 2018, we reported a net loss of $25.2 million, or $0.24 per share, compared to a net loss for same period in 2017 of $31.7 million, or $0.32 per share. We recognized revenue during the current quarter of $16 million which includes milestone achievements and non-cash royalties earned.

For the six months ended June 30, 2018, we reported a net loss of $79.5 million or $0.76 per share compared to a net loss for the same period in 2017 of $48.8 million or $0.51 per share. The increased net loss reflects reduced revenue due to an accelerated milestone received during 2017 from Incyte and the loss on early extinguishment of debt.

Conference Call, Webcast and Prepared Statement Information

Agenus executives will host a conference call on Thursday, August 9, 2018 at 8:30 a.m. Eastern Time. To access the live call, dial (844) 492-3727 (domestic) and (412) 317-5118 (international). Ask to be joined into the Agenus call. The call will also be webcast and will be accessible from the Company’s website at View Source or via the following link: View Source A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.

On August 9, 2018 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, reported financial results for the second quarter ended June 30, 2018 and provided a business update (Press release, Savara, AUG 9, 2018, View Source [SID1234528711]).

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"We have had an incredibly eventful and productive quarter," said Rob Neville, chief executive officer of Savara. "With two product candidates approaching pivotal data reads and our exploratory NTM program well underway, we believe we are heading into the most exciting twelve months in Savara’s history. Furthermore, the recent acquisition of the assets of Cardeas Pharma Corporation underlines our commitment to our vision to build a prominent orphan lung disease company. With the closing of our recent public offering, we have initiated preparations for Molgradex commercial launch for aPAP, as well as for a new clinical study in CF-affected individuals with chronic NTM infection, and will support our exploratory pipeline."

Upcoming Milestones and Recent Developments

Anticipating completion of enrollment in the Molgradex Phase 3 IMPALA study in Q3 2018. The IMPALA study is evaluating our inhaled formulation of granulocyte-macrophage colony-stimulating factor, or GM-CSF, for the treatment of autoimmune pulmonary alveolar proteinosis, or aPAP. At the end of Q2, enrollment was at 106 patients out of a total target of 135 patients, with completion of enrollment currently on track for Q3 2018 and topline data anticipated in Q2 2019.

Encouraging patient enrollment in the Molgradex IMPALA-X safety extension study. The IMPALA-X study is an open-label, multicenter study designed to determine the long-term safety and utilization of Molgradex in patients with aPAP. IMPALA-X offers patients the opportunity to continue treatment with Molgradex for up to three years after completion of the pivotal Phase 3 IMPALA study. Of the 14 subjects eligible to enroll into IMPALA-X at the end of Q2, 12 have enrolled to date, while the remaining 2 subjects are expected to enroll shortly.

Anticipating completion of enrollment in the Molgradex Phase 2a OPTIMA study in Q3 2018. The OPTIMA study is evaluating our inhaled GM-CSF for the treatment of nontuberculous mycobacterial (NTM) lung infection. At the end of Q2, enrollment was at 17 patients out of a total target of 30 patients, and completion of enrollment remains on track for Q3 2018. Interim results are anticipated in Q4 2018, and topline data anticipated in Q2 2019.

Anticipating completion of enrollment in the AeroVanc Phase 3 AVAIL study in Q1 2019. The AVAIL study is evaluating our vancomycin hydrochloride inhalation powder for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in individuals affected by cystic fibrosis. At the end of Q2, enrollment was at 107 patients out of a total target of 200 patients, with completion of enrollment currently on track for Q1 2019 and topline data anticipated in H2 2019.

Provided positive update on the development and commercialization of Molgradex. Savara has received positive investigator feedback on treatment with Molgradex in the open label portion of the IMPALA study, as well as a high interest in participation in the IMPALA-X study. The Company believes the high enrollment rates into the IMPALA-X study gives important insight into the level of satisfaction with Molgradex. Driven by its confidence in the outcome of the IMPALA study, Savara will expedite its preparation for potential commercial launch with investments into core commercial leadership and staff, as well as external activities required for a successful launch. Assuming robust results from the IMPALA study and subsequent breakthrough and/or fast track designation, submission of the Molgradex Biologic License Application, or BLA, is anticipated in the first half of 2020, with a resultant commercial launch in late 2020 or early 2021.

Announced expansion of the Molgradex program, with a Phase 2a clinical study in the U.S. in CF-affected individuals with chronic NTM lung infection expected to begin in Q1 2019. Savara is preparing to initiate a new open-label study in the U.S., which will enroll 30 subjects with chronic Mycobacterium abscessus (M. abscessus) or Mycobacterium avium complex (MAC) infection. The study will comprise a 48-week treatment period and a 24-week follow-up period. The primary endpoint in the study will be NTM sputum culture conversion to negative.

Launched exploratory product pipeline, announced the acquisition of the assets of Cardeas Pharma Corporation and the appointment of A. Bruce Montgomery, M.D., as strategic advisor. As part of Savara’s commitment to growth through innovation and acquisition, the Company launched its exploratory pipeline, focused on pre-proof-of-concept, high-potential programs in difficult-to-treat lung diseases, and announced the acquisition of Cardeas Pharma’s Phase 2 ready aerosolized amikacin/fosfomycin, a proprietary combination antibiotic. In connection with the acquisition, Savara appointed Dr. A. Bruce Montgomery, a leading pioneer in the field of inhaled antibiotics and other orphan lung disease products, as strategic advisor.

Successfully closed a public offering with gross proceeds of approximately $48.9 million. The offering was led largely by existing shareholders along with new institutional healthcare investors. The proceeds of the offering will be used for working capital and general corporate purposes, including helping to fund commercial preparatory efforts for Molgradex in aPAP, launching a new clinical study in CF-affected individuals with chronic NTM infection, and supporting Savara’s exploratory pipeline.
Second Quarter Financial Results

Savara’s net loss attributable to common shareholders for the three months ended June 30, 2018 was $11.6 million, or $(0.38) per share, compared with a net loss attributable to common shareholders of $12.5 million, or $(0.90) per share, for the three months ended June 30, 2017.

Research and development expenses were $9.3 million for the three months ended June 30, 2018, compared with $4.2 million for the three months ended June 30, 2017. This increase was due to several factors, including $2.3 million in additional expenses associated with the AeroVanc Phase 3 study activities; $1.8 million in development costs of Molgradex, including the expansion of the aPAP study in the U.S. and costs associated with the Phase 2 NTM study; and $1 million in expense related to the acquisition of assets from Cardeas.

General and administrative expenses for the three months ended June 30, 2018 were $2.5 million, compared with $5.1 million for the three months ended June 30, 2017. For the three months ended June 30, 2017, the Company recorded a $1.9 million change in fair value of the contingent consideration associated with its acquisition of Serendex compared to only $0.1 million for the three months ended June 30, 2018. In the second quarter of 2017, the Company incurred $1.7 million in expense associated with its merger transaction with Mast Therapeutics, Inc. (the "Merger") in April 2017, none of which was incurred in the second quarter of 2018. In the second quarter of 2018, Savara incurred approximately $0.9 million in additional costs related to personnel and other expenditures associated with public company requirements and activities. Other expense decreased by $2.7 million for the three months ended June 30, 2018 as compared to the same period in 2017. This decrease was primarily due to the second quarter of 2017 having $1.8 million of expense associated with the extinguishment of certain pre-Merger convertible promissory notes.

As of June 30, 2018, Savara had a debt balance of approximately $15.0 million and had cash, cash equivalents and short-term investments of approximately $74.8 million.

Conference Call and Webcast
Savara will hold a conference call today beginning at 5:30pm Eastern Time / 4:30pm Central Time to provide a business update. Shareholders and other interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and request the Savara Inc. call. A live webcast of the conference call will be available online in the Investors section of Savara’s website at View Source Replays of the webcast will be available on Savara’s website for 30 days and a telephone replay will be available through August 16, 2018 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada, and (412) 317-0088 from elsewhere outside the U.S. and entering replay access code 10122221.

On August 9, 2018 Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, reported its operating and financial results for the second quarter ended June 30, 2018 (Press release, Dova Pharmaceuticals, AUG 9, 2018, View Source [SID1234528822]).

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"In the second quarter, we achieved our most significant milestone in Dova’s corporate history with the approval and launch of DOPTELET in the United States" said Alex C. Sapir, President and Chief Executive Officer of Dova. "We are pleased with the feedback we are hearing from physicians both in terms of how the drug is performing clinically, as well as the reimbursement support their patients are receiving through DOVA1SOURCE. This has translated to a high level of payer approval, as over 80% of referrals have been approved. In addition, we remain well-positioned financially, with approximately $135M in cash and equivalents to fund the operational success of the company for the foreseeable future."

DOPTLET Launch Highlights

·On May 21st, DOPTELET was approved by the U.S. Food and Drug Administration (FDA) for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. DOPTELET was launched in the United States on June 4th.

·A total of 148 health care professionals have prescribed DOPTELET to their patients since launch with an increasing number using DOPTELET for multiple patients within their practice.

· For prescriptions that have completed the adjudication process with payers, the Company has seen greater than 80% of those prescriptions approved by the payer with an average approval time of 6.9 days.

·The Company has made significant progress in its outreach efforts to target prescribers having reached 62% of top hepatologists an average of 3.1 times since launch.

· Pivotal Phase 3 data for DOPTELET were published in Gastroenterology (View Source). The data were also highlighted at several key global scientific conferences including Digestive Disease Week (DDW) 2018, the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), and the 64th International Society on Thrombosis and Haemostasis (ISTH).

Other Important Highlights for the Quarter

·On April 27th, the Company submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for DOPTELET for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure. The EMA has granted a Standard Review Assessment with a targeted decision date of July 2019.

· A supplemental New Drug Application (sNDA) for the treatment of patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to a previous treatment remains on track for submission to the FDA in the third quarter of 2018.

· The Company has initiated a Phase 3 clinical trial for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT).

· The Company repaid, in full, the secured promissory note that was issued to Eisai on March 31, 2016 of $31.1 million. The Company refinanced a portion of the note by entering into a Loan and Security Agreement with Silicon Valley Bank (SVB) for $20.0 million on April 17, 2018. The loan matures on April 17, 2021 unless a specified revenue milestone is achieved in which case the maturity date will be extended to April 17, 2022.

·Nancy J. Wysenski, an industry veteran with over 30 years of commercial and sales leadership, joined the Company’s Board of Directors. As the former Chief Commercial Officer at Vertex, she was responsible for launching Incivek, a treatment for hepatitis C, which is considered by many to be the most successful drug launch in U.S. history.

Dova will provide an update and additional details on DOPTELET’s launch activities during today’s call as well as at its upcoming Investor and Analyst Day scheduled for September 20, 2018 in New York City, New York. To RSVP for this event, please email John Woolford at [email protected].

Second Quarter and Financial Results

Dova reported a net loss of $20.0 million for the second quarter of 2018, compared to a net loss of $5.5 million for the same period in 2017.

For the second quarter of 2018, Dova reported net product sales from DOPTELET of $2.0 million. The Company recognizes revenue using the sell-in methodology when products are delivered to its specialty pharmacy partners. The majority of net sales recognized in the quarter were related to the initial stocking of DOPTELET at the specialty pharmacies. In addition, in March 2018, Dova entered into an exclusive distribution agreement with Shanghai Fosun Pharmaceutical Industrial

Development Co., Ltd., (Fosun Pharma Industrial). Dova received a $5.0 million upfront payment from Fosun Pharma Industrial of which $2.6 million was recognized as revenue during the second quarter of 2018. There were no product sales or other revenue in the second quarter of 2017.

Cost of product sales for the second quarter were $0.5 million, of which approximately $0.3 million consisted of a one-time stock-based compensation charge.

Research and development expenses were $4.5 million in the second quarter of 2018, compared to $3.3 million for the same period in 2017. The increase was primarily due to the initiation of Phase 3 clinical trials to evaluate DOPTELET for patients with thrombocytopenia undergoing surgery regardless of disease etiology and chemotherapy-induced thrombocytopenia.

Selling, general and administrative expenses were $18.6 million in the second quarter of 2018, compared to $1.9 million for the same period in 2017. The increase was primarily due to building Dova’s commercial infrastructure to support the launch of DOPTELET, increased corporate infrastructure, and additional costs associated with operating as a public company.

As of June 30, 2018, Dova had $134.7 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, August 9, 2018 at 4:30 p.m. ET to discuss second quarter 2018 financial results and 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 9093837 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 August 9, 2018 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported financial results for the three months ended June 30, 2018 and provided a corporate update (Press release, Portola Pharmaceuticals, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363072 [SID1234528581]).

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"The second quarter of 2018 brought a significant addition to our product suite with the U.S. Food and Drug Administration’s Accelerated Approval of Andexxa and the initiation of our Early Supply Program. Together with Bevyxxa, we now have two FDA-approved, first-and-only medicines for their indications in the field of thrombosis with the potential to impact public health," said Mardi Dier, interim co-president and chief financial officer of Portola. "In the second half of the year, we remain focused on continuing to lay the foundation for the U.S. launch of Bevyxxa and preparing for a number of significant milestones, including our regulatory submission in the U.S. for the Generation 2 Andexxa product, review and potential approval for andexanet alfa in Europe, and determining the development and regulatory path forward for cerdulatinib, our Syk/JAK inhibitor and the third novel compound discovered in our labs."

Second Quarter 2018 Financial Results
Total revenue for the second quarter of 2018 was $4.0 million, compared with $3.8 million for the second quarter of 2017. This includes $1.7 million in collaboration and license revenue earned under Portola’s collaboration and license agreements with Bristol-Myers Squibb Company, Pfizer, Bayer Pharma, Janssen Pharmaceuticals and Daiichi Sankyo, as well as $2.2 million from initial sales of Andexxa in the U.S. under the Company’s Early Supply Program launched in May 2018, and $33,000 in product revenue from sales of Bevyxxa, which launched in the U.S. in January 2018.

Total operating expenses for the second quarter of 2018 were $107.7 million, compared with $69.6 million for the same period in 2017. Total operating expenses for the second quarter of 2018 included $13.2 million in stock-based compensation expense, compared with $13.3 million for the same period in 2017.

Research and development expenses were $66.4 million for the second quarter of 2018, compared with $49.3 million for the second quarter of 2017. The increase is due to the second Generation 2 Andexxa commercial manufacturing campaign. Selling, general and administrative expenses for the second quarter of 2018 were $40.2 million, compared with $20.3 million for the same period in 2017. The increase is due to the build-out of the field force and marketing spend for the Andexxa Early Supply Program and the Bevyxxa launch.

For the second quarter of 2018, Portola reported a net loss of $106.2 million, or $1.61 net loss per share, compared with a net loss of $69.7 million, or $1.22 net loss per share, for the same period in 2017. Shares used to compute net loss per share attributable to common stockholders were 65.9 million for the second quarter of 2018 compared with 57.1 million for the same period in 2017.

Cash, cash equivalents and investments at June 30, 2018 totaled $456.7 million, compared with $534.2 million as of December 31, 2017.

Based on the FDA approval of Andexxa in May 2018, the Company earned an additional $100 million milestone payment from its royalty-based financing arrangement with Health Care Royalty Partners.

Recent Achievements and Events

Received Accelerated Approval from the FDA for Andexxa and initiated commercial launch under the Early Supply Program.
Completed the second successful manufacturing campaign of Generation 2 Andexxa product.
Continued progress with the Bevyxxa U.S. commercial launch, including formulary wins, reimbursement coverage and physician education.
New interim results from the ongoing Phase 2a study of cerdulatinib presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper).
Four abstracts presented at the International Society on Thrombosis and Haemostasis (ISTH) meeting.
Received New Technology Add-on Payment for Andexxa from the Centers for Medicare and Medicaid Services.
Upcoming Milestones

Eight abstracts to be presented at the European Society of Cardiology (ESC) meeting.
Submit Prior Approval Supplement (PAS) for Generation 2 Andexxa product by the end of August, positioning the Company for a broader commercial launch in early 2019, upon FDA approval.
On track to deliver additional data to European regulatory authorities in the fourth quarter, with potential for European approval of andexanet alfa in the first half of 2019.
Ongoing discussion with the FDA on the potential regulatory pathway for cerdulatinib.
Conference Call Details
Portola will host a conference call today, Thursday, August 9, 2018, at 8:30 a.m. ET, during which time management will discuss the second quarter 2018 financial results, updates on the U.S. launches of Andexxa and Bevyxxa, and other matters. The live call can be accessed by phone by dialing (844) 452-6828 from the U.S. and Canada or 1 (765) 507-2588 internationally and using the passcode 6650817. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.