On March 5, 2019 TESARO, an oncology-focused business within GSK, reported that data for dostarlimab (anti-PD-1 antibody, formerly TSR-042) and Zejula (niraparib) will be presented at the 2019 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer being held March 16-19 in Honolulu, Hawaii (Press release, TESARO, MAR 5, 2019, View Source [SID1234534006]).

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"At this year’s SGO meeting, data will be presented from the GARNET trial of dostarlimab in recurrent endometrial cancer patients, including patients with recurrent MSS endometrial cancer, for which limited treatment options exist today," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We are on track to submit a BLA for dostarlimab by the end of the year. Data will also be presented from several studies of Zejula in patients with ovarian cancer, including safety data from the fully enrolled Phase 3 PRIMA study of Zejula as a first-line maintenance therapy for ovarian cancer regardless of BRCA status."

Please plan to visit TESARO at Booth #207 for information on the expanded development program for Zejula, dostarlimab and our broader pipeline.

Oral Presentations Information (all times local):

Dostarlimab (TSR-042)

Tuesday, March 19, 2019, 7:45 AM to 9:00 AM
Preliminary safety, efficacy, and pharmacokinetic/pharmacodynamic characterization from GARNET, a phase I/II clinical trial of the anti–PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced MSI-H and MSS endometrial cancer (EC)
Oral in the Scientific Plenary VI, Abstract: 33, Location: Kamehameha 3

Zejula (niraparib)

Saturday, March 16, 2019, 6:45 AM to 7:45 AM
Time without symptoms or toxicity in patients with recurrent ovarian cancer receiving niraparib maintenance treatment versus placebo: A TWIST analysis of the ENGOT-OV16/NOVA trial
Oral in the Scientific Plenary I, Abstract: 1, Location: Kamehameha 3

Saturday, March 16, 2019, 6:45 AM to 7:45 AM
Baseline platelet count and body weight as predictors of early dose modification in the QUADRA trial of niraparib monotherapy for the treatment of heavily pretreated (≥4th line), advanced, recurrent high-grade serous ovarian cancer (OC)
Oral in the Scientific Plenary I, Abstract: 2, Location: Kamehameha 3

Saturday, March 16, 2019, 6:45 AM to 7:45 AM
A prospective evaluation of tolerability of niraparib dosing based upon baseline body weight and platelet count: Blinded pooled interim safety data from the ENGOT-OV26/PRIMA study
Oral in the Scientific Plenary I, Abstract: 3, Location: Kamehameha 3

Niraparib is marketed in the United States and Europe under trade name Zejula.

About Zejula (niraparib)
Zejula (niraparib) is a poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, Zejula concentrates in the tumour relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumour effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with Zejula. Discontinue Zejula if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with Zejula. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. Zejula can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.

About GARNET
The ongoing Phase I/II GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumors. GARNET included a weight-based dose escalation study (Part 1) and a fixed-dose safety study (Part 2A), both of which have been completed. Results of these studies were used to determine the recommended Phase 2 dose (RP2D; 500 mg Q3W for the first 4 cycles then 1000 mg Q6W). Part 2B of the study includes four large expansion cohorts: MSI-H endometrial cancer, MSI-H non-endometrial cancer, MSS endometrial cancer, and non-small cell lung cancer (NSCLC).

About dostarlimab
Dostarlimab (TSR-042) is an investigational humanized anti-programmed death (PD)-1 monoclonal antibody that binds with high affinity to the PD-1 receptor and effectively blocks its interaction with the ligands PD-L1 and PD-L2. Dostarlimab is the only anti-PD-1 therapy administered as monotherapy every 3 weeks for 4 doses then every 6 weeks thereafter. Dostarlimab was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3 (TSR-075).

On March 5, 2019 Five Prime Therapeutics, Inc.(NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics reported that Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics, will present at the 39TH Annual Cowen Healthcare Conference onWednesday, March 13, 2019 at 8:40am ET (Press release, Five Prime Therapeutics, MAR 5, 2019, http://investor.fiveprime.com/news-releases/news-release-details/five-prime-therapeutics-present-cowen-and-company-39th-annual [SID1234534022]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at: View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.

On March 4, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported the company will present at two upcoming investor conferences BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported the company will present at two upcoming investor conferences:

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The Cowen and Company 39th Annual Health Care Conference in Boston on Monday, March 11th at 4:10 p.m. ET; and
The 2019 Barclays Global Healthcare Conference in Miami on Wednesday, March 13th at 3:20 p.m. ET.
Live webcasts can be accessed from the investors section of BeiGene’s website at View Source and archived replays will be available for 90 days following the event.:

The Cowen and Company 39th Annual Health Care Conference in Boston on Monday, March 11th at 4:10 p.m. ET; and
The 2019 Barclays Global Healthcare Conference in Miami on Wednesday, March 13th at 3:20 p.m. ET.
Live webcasts can be accessed from the investors section of BeiGene’s website at View Source and archived replays will be available for 90 days following the event.

On March 4, 2019 DURECT Corporation’s (Nasdaq: DRRX) fourth quarter 2018 financial results press release, you are invited to listen to a conference call that will be broadcast live over the internet on Thursday, March 7, 2019 at 4:30 pm Eastern Time (1:30 pm Pacific Time) (Press release, DURECT, MAR 4, 2019, http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID=2389891 [SID1234533933]).

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A live audio webcast of the presentation will be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.

On March 4, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the fourth quarter and full year ended December 31, 2018, and provided a corporate update (Press release, BioCryst Pharmaceuticals, MAR 4, 2019, View Source [SID1234533918]).

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"In a year with many transformative milestones for BioCryst, it has been exciting to see so much progress already in the first two months of the year. The strong Phase 2 clinical data from our now-completed ZENITH-1 trial propels our BCX7353 acute program for HAE into Phase 3 development. With the very favorable preclinical profile of BCX9930, another novel BioCryst-invented oral drug for rare diseases, we are advancing that program into the clinic in the second quarter for the treatment of complement-mediated diseases. We also added further rare disease expertise to our board and increased our financial flexibility with a $100 million debt agreement," said Jon Stonehouse, president and chief executive officer of BioCryst.

"We remain on-track for the readout of our APeX-2 trial next quarter, and an NDA filing of BCX7353 for HAE prophylaxis by the end of the year. We are thoughtfully building our commercial leadership and infrastructure to execute a successful launch that meets the urgent demand for a once-daily oral therapy that will allow HAE patients to live a more normal life," Stonehouse added.

Recent Milestones

The company has dosed the first patients in its APeX-J trial in Japan, designed to support potential Japanese approval of BCX7353 for the prevention of HAE attacks.

On March 4, 2019, the company announced that it is advancing BCX9930, an oral Factor D inhibitor, into Phase 1 clinical development in the second quarter of 2019 for the treatment of complement-mediated diseases.
On February 23, 2019, the company announced data from the completed ZENITH-1 trial (including the 250 mg and 500 mg dose cohorts) of BCX7353 for the acute treatment of HAE attacks at the annual meeting of the American Academy of Allergy, Asthma & Immunology. The company plans to commence a Phase 3 trial, ZENITH-2, in the summer of 2019.

On February 6, 2019, the company announced it had entered into a $100 million secured credit facility with MidCap Financial Trust pursuant to the terms and conditions of an amended and restated credit and security agreement.

On January 4, 2019, the company announced it had appointed Steve Aselage to its board of directors.

On January 2, 2019, the company announced the dosing of the first subject in a randomized, placebo-controlled Phase 1 clinical trial to evaluate intravenous galidesivir, its investigational broad-spectrum antiviral drug, in healthy volunteers.
Fourth Quarter 2018 Corporate Developments

On November 20, 2018, BioCryst announced that it had appointed Theresa Heggie to its board of directors.

On November 16, 2018, BioCryst presented data that showed an oral formulation of BCX7353 was rapidly absorbed and exhibited a long half-life, two important characteristics of desired new acute treatments for HAE attacks, at the annual scientific meeting of the American College of Allergy, Asthma & Immunology.
Upcoming Key Milestones

HAE Program – BCX7353

Report 24-week safety and efficacy results from the APeX-2 clinical trial (Q2 2019)

Begin a Phase 3 clinical trial of oral BCX7353 for the acute treatment of HAE (Summer 2019)

File a new drug application (NDA) for oral BCX7353 for the prevention of HAE attacks with the U.S. Food and Drug Administration (FDA) (Q4 2019)
Complement Factor D Inhibitor Program – BCX9930

Begin a Phase 1 trial of BCX9930, an oral Factor D inhibitor for treatment of complement-mediated diseases, in healthy subjects (Q2 2019)

Report Phase 1 results (Q4 2019)
ALK-2 Inhibitor Program – BCX9250

Begin a Phase 1 clinical trial of BCX9250, an oral ALK-2 kinase inhibitor for treatment of fibrodysplasia ossificans progressiva, in healthy subjects (2H 2019)
Fourth Quarter 2018 Financial Results

For the three months ended December 31, 2018, total revenues were $2.7 million, compared to $3.9 million in the fourth quarter of 2017. The decrease was primarily due to a reduction of royalty revenue associated with differences in the onset and severity of the influenza seasons between the two periods. This decrease was partially offset by increased revenue from government contracts for galidesivir development, which was higher in the fourth quarter of 2018.

Research and development (R&D) expenses for the fourth quarter of 2018 increased to $23.4 million from $16.9 million in the fourth quarter of 2017, primarily due to increased spending on the company’s HAE and preclinical programs.

General and administrative (G&A) expenses for the fourth quarter of 2018 decreased slightly to $4.5 million, compared to $4.7 million in the fourth quarter of 2017. The decrease was primarily due to the lack of merger-related costs in the fourth quarter of 2018 associated with the company’s terminated merger with Idera Pharmaceuticals, Inc. (Idera). The decrease in G&A expense due to the lack of merger expenses was largely offset by higher commercial and medical affairs expenses in the fourth quarter of 2018.

Interest expense was $2.4 million in the fourth quarter of 2018, compared to $2.2 million in the fourth quarter of 2017 and was associated with enhancing our secured credit facility in July 2018.

Net loss for the fourth quarter of 2018 was $27.4 million, or $0.25 per share, compared to a net loss of $19.5 million, or $0.20 per share, for the fourth quarter of 2017.

Cash, cash equivalents and investments totaled $128.4 million at December 31, 2018, and reflect a decrease from $159.0 million at December 31, 2017. Cash and investments reflect the proceeds from a July 2018 enhancement to our secured credit facility and an August 2018 public equity offering, offset by normal operating expenses and merger-related costs incurred in the 12-month period. Operating cash use for the fourth quarter of 2018 was $22.6 million, and for the full year of 2018 was $93.4 million.

On February 6, 2019, the company announced it had entered into a $100 million secured credit facility with MidCap Financial Trust which further enhanced the company’s cash position with $20 million of immediate additional non-dilutive capital and provided additional financial flexibility by providing the ability to draw another $50 million of milestone-based non-dilutive capital.

Full Year 2018 Financial Results

For the full year ended December 31, 2018, total revenues were $20.7 million, compared to $25.2 million in the full year ended December 31, 2017. The decrease in revenue was primarily associated with infrequent revenue events that occurred in 2017 that did not recur in 2018, as well as a $2.1 million decrease in revenue associated with development activities under U.S. government contracts in 2018. The non-recurring 2017 events were the recognition of $4.1 million of royalty revenue from Japanese government stockpiling of RAPIACTA and the recognition of $1.5 million of peramivir product sales from the company’s commercial partner, Green Cross Corporation. These decreases were partially offset by a $5.0 million milestone associated with the European Medicines Agency’s (EMA) approval of peramivir (ALPIVABTM) recognized in the second quarter of 2018.

R&D expenses in 2018 increased to $84.9 million from $67.0 million in 2017, primarily due to increased spending on our HAE and preclinical programs. These increases were partially offset by a decrease in the company’s peramivir and galidesivir development spending in 2018.

G&A expenses in 2018 increased to $29.5 million, compared to $13.9 million in 2017. The increase was primarily due to approximately $11 million of merger-related costs associated with the company’s terminated merger with Idera and a $4.9 million reserve for collectability of the EMA approval milestone of peramivir.

Interest expense was $9.2 million in 2018, compared to $8.6 million in 2017.

Net loss for 2018 was $101.3 million, or $0.98 per share, compared to a net loss of $65.8 million, or $0.78 per share, for 2017.

Financial Outlook for 2019

BioCryst expects net operating cash use to be in the range of $105 to $130 million, and its 2019 operating expenses to be in the range of $120 to $145 million. The company’s operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the company’s stock, as well as by the vesting of the company’s outstanding performance-based stock options.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 1271286. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID# 1271286.