On August 5, 2019 Omeros Corporation (NASDAQ: OMER) reported that the company will issue its second quarter 2019 financial results for the period ended June 30, 2019, on Thursday, August 8, 2019, after the market closes (Press release, Omeros, AUG 5, 2019, View Source [SID1234538208]). Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

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Conference Call Details

To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 1697797. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 1697797.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at www.omeros.com and select "Events" under the Investors section of the website. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On August 5, 2019 Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, reported that it has completed enrollment five months ahead of schedule in the Company’s Phase 3 CONDOR study evaluating the diagnostic performance and clinical impact of PyLTM (18F-DCFPyL) in men with biochemical recurrence of prostate cancer (Press release, Progenics Pharmaceuticals, AUG 5, 2019, View Source [SID1234538165]). PyL is the Company’s PSMA-targeted small molecule PET/CT imaging agent designed to visualize prostate cancer.

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The Company also reported that it recently met with the U.S. Food and Drug Administration (FDA) to discuss the regulatory path for PyL. Based on those discussions, the Company believes that positive data from the CONDOR study and the previously reported OSPREY study could serve as the basis for a regulatory submission. Progenics intends to submit a New Drug Application (NDA) with the FDA for PyL following the Phase 3 CONDOR study, assuming positive results.

"We have made significant progress with our PyL program in recent months on both the clinical and regulatory fronts, demonstrating our ability to execute complex, multi-center studies under ambitious timelines," said Vivien Wong, Ph.D., Executive Vice President, R&D, of Progenics. "The accelerated enrollment completion in our Phase 3 CONDOR study underscores the clinical interest in our PSMA-targeted imaging agent and the need for better diagnostic options for patients with biochemical recurrent prostate cancer."

Dr. Wong continued, "We believe that PyL has the potential to alter physician treatment plans and improve patient outcomes through the detection of small nodal and metastatic lesions that are missed by currently available conventional imaging modalities. Currently, over 1,000 men with prostate cancer have been imaged with PyL in the clinical setting. We look forward to rapidly advancing this program toward NDA submission and commercialization following positive CONDOR data. We are grateful to the patients and their caregivers who participated in the trial, and to the investigators and their study staff for their extraordinary efforts in executing this study ahead of schedule."

The Phase 3 CONDOR study is a multi-center, open label study that dosed 208 patients with biochemical recurrence of prostate cancer at 14 sites in the United States and Canada. The primary endpoint is based on positive predictive value and will assess the correct localization rate (CLR), defined as a percentage of subjects with a one-to-one correspondence between localization of at least one lesion identified by PyL and the composite truth standard. Secondary measures include the percentage of subjects with a change in intended prostate cancer treatment plans due to PyL PET/CT imaging.

About PyL for PET Imaging of Prostate Cancer

PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted Positron Emission Topography ("PET") imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. Progenics initiated patient dosing of the Phase 3 study evaluating the diagnostic performance and clinical impact of PyL in November 2018. The last patient visit is expected in September and top-line data is expected by year end.

PyL and 1095

The multicenter, randomized, open-label, controlled Phase 2 clinical study is evaluating the efficacy and safety of I-131-1095 in combination with enzalutamide compared to enzalutamide alone in patients with mCRPC who are PSMA-avid, chemotherapy naïve, and progressed on abiraterone. PSMA-avidity is determined utilizing PyL imaging which enrich for patients who are most likely to respond to 1095 therapy, highlighting the synergistic potential of our PSMA-targeted pipeline to better diagnose and treat prostate cancer. Based on the early data from this open-label study and dialogue with the FDA, we plan to evaluate initiating a pivotal trial of 1095 in 2020.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

On August 5, 2019 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the second quarter ended June 30, 2019 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, AUG 5, 2019, View Source [SID1234538164]).

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"Strong momentum is with us as we move closer to our goal of releasing topline data from no fewer than five clinical trials over the next 18 months," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "First and foremost, we look forward to announcing topline results from the pivotal ADVOCATE Phase III trial of avacopan in ANCA-associated vasculitis in the fourth quarter of this year. The ADVOCATE trial is based on a wealth of data from well controlled pharmacological and clinical studies, including the successful multi-center, placebo controlled CLEAR and CLASSIC Phase II clinical trials. That foundation provides the basis for optimism that avacopan will provide much needed relief for ANCA patients."

"Recently we reached another milestone by completing patient enrollment in our LUMINA 1 trial of our second drug candidate, CCX140, in patients with primary FSGS, and we expect to release topline data in the first half of the coming year."

"Rounding out the pipeline readout roster through the coming year, our clinical trials of avacopan in C3 glomerulopathy and hidradenitis suppurativa, along with our LUMINA 2 trial of CCX140 in patients with nephrotic proteinuria primary FSGS, are also enrolling well. We expect to release top line data from these three clinical trials during the course of 2020."

"We continue to execute on our 2019 goals, fortified by our strong financial position. In short, we have the people, the assets, and the experience to deliver real value to investors and patients alike, as I believe this important time in our history will now begin to reveal."

Recent Highlights

Remained on track for Q4 topline data from the ADVOCATE global Phase III trial of avacopan in 331 patients with ANCA-associated Vasculitis.

Completed patient screening in the Company’s LUMINA 1 Phase II randomized clinical trial of CCX140, an inhibitor of the chemokine receptor known as CCR2, in patients with sub-nephrotic primary Focal Segmental Glomerulosclerosis (FSGS), another rare kidney disease. The last patient is expected to be randomized in mid-August and top line data anticipated in the first half of 2020. The single-arm, open label LUMINA 2 study continues to enroll, evaluating CCX140 in patients with the rarer and more severe nephrotic proteinuria primary FSGS.

ACCOLADE Phase II clinical trial of avacopan in patients with the rare kidney disease C3 Glomerulopathy (C3G, a devastating and expensive kidney disease with no approved effective treatment), reached fifty percent in overall enrollment and nearly 100% in the first stratum of patients with high levels of activated complement in the blood.

Acceleration in site activation and patient enrollment in the Company’s AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS), with over 50% sites now activated and approximately 25% patients enrolled to date.

First Quarter 2019 Financial Results

Revenue was $7.2 million for the second quarter of 2019, compared to $15.0 million for the same period in 2018. Revenue is recognized based on the proportionate amount of costs incurred as a percentage of total budgeted costs to fulfill the performance obligations under the Company’s avacopan and CCX140 commercialization agreements with Vifor Pharma. The decrease from 2018 to 2019 was primarily due to a higher proportion of avacopan related costs relative to budgeted costs incurred in 2018.

Research and development expenses were $17.6 million for the second quarter of 2019, compared to $17.8 million for the same period in 2018. Expenses decreased in 2019 for the avacopan ADVOCATE Phase III pivotal trial as the study was fully enrolled in 2018, while Phase II clinical expenses increased primarily due to patient enrollment of the avacopan AURORA Phase II clinical trial in patients with HS and the two CCX140 LUMINA Phase II clinical trials in patients with FSGS.

General and administrative expenses were $5.6 million for the second quarter of 2019, compared to $4.7 million for the same period in 2018. The increase from 2018 to 2019 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.

Net loss for the second quarter of 2019 was $15.2 million, compared to $6.9 million for the same period in 2018.

Total shares outstanding at June 30, 2019 were approximately 58.2 million shares.

Cash, cash equivalents and investments totaled $223.1 million at June 30, 2019. The Company expects to utilize cash and investments in the range of $70.0 million to $80.0 million in 2019.

Conference Call and Webcast

The Company will host a conference call and webcast today, August 5, 2019 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 7548439. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On August 5, 2019 Acceleron Pharma Inc. (Nasdaq:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, reported a corporate update and reported financial results for the second quarter ended June 30, 2019 (Press release, Acceleron Pharma, AUG 5, 2019, View Source [SID1234538163]).

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"The significant progress across our entire pipeline over the last few years has us well positioned to execute during one of the most exciting times in Acceleron’s 16-year history. With the luspatercept U.S. and European regulatory approval filings under review, we are now one step closer to the first-ever potential approval of an Acceleron-discovered medicine," said Habib Dable, President and Chief Executive Officer of Acceleron. "Alongside our global collaboration partner, Celgene, we are focused on preparing for luspatercept’s potential commercial launch, and we continue to execute on our ongoing clinical trials in first-line lower-risk MDS-, non-transfusion-dependent beta-thalassemia- and myelofibrosis-associated anemia."

Added Mr. Dable: "In parallel, we have advanced our two Acceleron-led clinical programs in neuromuscular and pulmonary disease as we work to establish key proof-of-concept results in three placebo-controlled Phase 2 trials over the next nine months. Following robust enrollment in our PULSAR Phase 2 trial in patients with PAH, we now expect topline results in the first quarter of 2020. For ACE-083, we anticipate topline results in patients with FSHD and CMT in the second half of this year and early 2020, respectively."

Development Program Highlights

Hematology

Luspatercept: Myelodysplastic Syndromes (MDS), Beta-Thalassemia, and Myelofibrosis (MF)
Luspatercept is an investigational first-in-class erythroid maturation agent designed to address a late-stage erythroid maturation defect that results in chronic anemia and the need for regular red blood cell transfusions in adults with serious hematologic diseases. Luspatercept is part of the global collaboration between Acceleron and Celgene.

The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for luspatercept for the treatment of adult patients with very low- to intermediate-risk MDS-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions.

The FDA granted priority review for the beta-thalassemia indication and set a target action date of December 4, 2019, and set a target action date of April 4, 2020, for the MDS indication.

The Marketing Authorization Application (MAA) for luspatercept in adult patients with MDS- or beta-thalassemia-associated anemia has been validated by the European Medicines Agency (EMA). The EMA decision on the MAA is expected in the second half of 2020.

Results from the Phase 2 trial of luspatercept in patients with MF are expected later this year.

Enrollment is ongoing in the COMMANDS Phase 3 trial in patients with treatment-naïve lower-risk MDS and the BEYOND Phase 2 trial in patients with non-transfusion-dependent beta-thalassemia. Topline results from the BEYOND trial are expected by year-end 2020.

Neuromuscular Disease

ACE-083: Facioscapulohumeral Muscular Dystrophy (FSHD) and Charcot-Marie-Tooth Disease (CMT)
ACE-083 is an investigational locally-acting therapeutic designed to have a concentrated effect on muscle mass and strength in target muscles for diseases that cause focal muscle weakness. ACE-083 utilizes the "Myostatin+" approach to inhibit multiple TGF-beta superfamily ligands involved in muscle formation.

Topline results from Part 2 of the Phase 2 trial in patients with FSHD are expected in the second half of 2019.

Enrollment was recently completed in Part 2 of the Phase 2 trial in patients with CMT, with topline results expected in the first quarter of 2020.

The Phase 2 extension trial is open for patients who participated in the FSHD and CMT Phase 2 trials of ACE-083.

Pulmonary Disease

Sotatercept: Pulmonary Arterial Hypertension (PAH)
Sotatercept is an investigational agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance BMPR2 signaling, which is a key molecular driver of PAH. In preclinical studies of PAH, sotatercept reversed pulmonary vessel muscularization and improved indicators of right heart failure.

The PULSAR Phase 2 trial in patients with PAH has completed enrollment, with topline results expected in Q1 2020.

Enrollment is ongoing in the exploratory SPECTRA trial in patients with PAH, with preliminary results expected in 2020.

Financial Results

Cash Position – Cash, cash equivalents and investments as of June 30, 2019 were $500.9 million. This cash balance includes the receipt of a $25.0 million gross milestone payment for the acceptance of the luspatercept BLA and MAA filings. As of December 31, 2018, the Company had cash, cash equivalents and investments of $291.3 million. Based on the Company’s current operating plan and projections, it believes that current cash, cash equivalents and investments will be sufficient to fund projected operating requirements until such time as it expects to receive significant royalty revenue from luspatercept sales.

Revenue – Second quarter revenue was $27.7 million. The revenue is all from the Company’s collaboration partnership with Celgene, and is largely related to the milestone payment received, as well as expenses incurred by the Company in support of luspatercept.

Costs and Expenses – Total costs and expenses for the second quarter were $48.8 million. This includes R&D expenses of $34.8 million and G&A expenses of $14.0 million.

Net Loss – The Company’s net loss for the second quarter ended June 30, 2019 was $17.9 million.

Conference Call and Webcast

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The Company will host a webcast and conference call to discuss its second quarter 2019 financial results and provide an update on recent corporate activities on August 5, 2019, at 5:00 p.m. EDT.

The webcast will be accessible under "Events & Presentations" in the Investors/Media page of the Company’s website at www.acceleronpharma.com. Individuals can participate in the conference call by dialing 877-312-5848 (domestic) or 253-237-1155 (international) and referring to the "Acceleron Second Quarter 2019 Earnings Call."

The archived webcast will be available for replay on the Acceleron website approximately two hours after the event.

On August 5, 2019 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported that it will release second quarter 2019 financial and operating results on Thursday, August 8, 2019 after the close of the U.S. financial markets and will host a conference call and webcast that day at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results and corporate developments (Press release, Biolase Technology, AUG 5, 2019, View Source [SID1234538154]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is (888) 224-1121. For international participants outside the U.S./Canada, the dial-in number is (323) 794-2575. For all callers, refer to the Conference ID 8907391. To access the live webcast, go to BIOLASE Investor Events Page.

An audio archive of the webcast will be available for 30 days on the Investors section of the BIOLASE website.