On October 30, 2018 Acceleron Pharma Inc. (Nasdaq:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, reported financial results for the third quarter ended September 30, 2018.

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"2018 is proving to be a pivotal year for Acceleron, and with several key milestones approaching, we are well-positioned for future growth. Along with our global collaboration partner, Celgene, we expect to share results from the MEDALIST and BELIEVE Phase 3 trials of luspatercept with the global hematology community at the upcoming ASH (Free ASH Whitepaper) meeting in December. With the recent initiation of the COMMANDS Phase 3 trial, we now have ongoing clinical trials with luspatercept in three additional patient populations. We remain committed to further exploring luspatercept’s potential to be a platform treatment for a range of anemias," said Habib Dable, President and Chief Executive Officer of Acceleron. "Our neuromuscular and pulmonary teams have done a tremendous job in getting multiple Phase 2 trials underway for ACE-083 in patients with FSHD and CMT, and sotatercept in patients with PAH. Both programs will have multiple important inflection points over the next two years."

Development Program Highlights

Hematology

Luspatercept:

Myelodysplastic Syndromes (MDS), Beta-Thalassemia, and Myelofibrosis (MF)
Luspatercept is a first-in-class erythroid maturation agent (EMA) 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 MEDALIST and BELIEVE Phase 3 trial results in patients with lower-risk MDS and transfusion-dependent beta-thalassemia, respectively, are expected to be presented at the 60th ASH (Free ASH Whitepaper) Annual Meeting and Exposition in December 2018.

Acceleron and Celgene plan to submit regulatory applications for both MDS and beta-thalassemia in the United States and Europe in the first half of 2019.

The COMMANDS Phase 3 trial in patients with lower-risk MDS who are treatment naïve has been initiated.

Enrollment is ongoing in the BEYOND Phase 2 trial in patients with non-transfusion-dependent beta-thalassemia as well as the Phase 2 trial in patients with MF.

ACE-083:

Facioscapulohumeral Muscular Dystrophy (FSHD) and Charcot-Marie-Tooth Disease (CMT)
ACE-083 is a 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 ligands involved in muscle formation.

Final results from Part 1 of each Phase 2 trial with ACE-083 in patients with FSHD and CMT, respectively, were presented at the 2018 World Muscle Society (WMS) Annual Meeting.

Enrollment is ongoing in Part 2 of the Phase 2 FSHD trial, with preliminary results expected in the second half of 2019.

Enrollment is ongoing in Part 2 of the Phase 2 CMT trial, with preliminary results expected by the end of 2019.

ACE-2494:
ACE-2494 is designed to have a systemic effect on muscle mass and strength for diseases that cause muscle weakness throughout the body. ACE-2494 utilizes the "Myostatin+" approach to inhibit multiple TGF-beta ligands involved in muscle formation.

Enrollment is ongoing in the Phase 1 healthy volunteer trial with preliminary results expected in the first half of 2019.

Pulmonary Disease

Sotatercept:

Pulmonary Arterial Hypertension (PAH)
Sotatercept acts as a ligand trap for members of the TGF-beta superfamily that control the BMPRII signaling pathway, which is critical for maintaining healthy pulmonary vasculature. In multiple preclinical studies in PAH, sotatercept significantly decreased pulmonary vessel muscularization, improved pulmonary arterial pressures, and decreased indicators of right heart failure.

Multiple preclinical abstracts for sotatercept in PAH have been accepted for presentation at the American Heart Association Scientific Sessions on November 10-12, 2018.

On November 16, 2018, the Company will host a PAH Research and Development Deep Dive event in New York City.

Enrollment is ongoing in the PULSAR Phase 2 trial in patients with PAH, with preliminary results expected in the first half of 2020.

The Company plans to initiate an exploratory study, called SPECTRA, in Q1 2019 to provide further understanding of sotatercept’s impact on the disease.

Financial Results

Cash position – Cash, cash equivalents and investments as of September 30, 2018 were $319.8 million. As of December 31, 2017, the Company had cash, cash equivalents and investments of $372.9 million. The Company believes that existing cash, cash equivalents and investments will be sufficient to fund projected operating requirements into 2021.

Revenue – Collaboration revenue for the third quarter was $3.3 million. The revenue is all from Acceleron’s partnership with Celgene and is primarily related to expenses incurred by the Company in support of luspatercept.

Costs and expenses – Total costs and expenses for the third quarter were $33.4 million. This includes R&D expenses of $24.7 million and G&A expenses of $8.7 million.

Net loss – The Company’s net loss for the third quarter ended September 30, 2018 was $29.0 million.
Conference Call and Webcast
The Company will host a webcast and conference call to discuss its third quarter financial results for 2018 and provide an update on recent corporate activities on October 30, 2018, at 4:30 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 Third Quarter 2018 Earnings Call."

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

On October 30, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $118.3 million and screened approximately 241,000 people with Cologuard during the quarter ended September 30, 2018 (Press release, Exact Sciences, OCT 30, 2018, View Source [SID1234530394]). Third-quarter 2018 revenue and Cologuard test volume grew by 63 percent and 49 percent, respectively, from the same period of 2017.

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"The Exact Sciences team delivered another strong quarter, highlighted by significantly increased patient access to Cologuard with no out-of-pocket cost and continued progress toward our 2018 priorities," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are enthusiastic about our partnership with Pfizer and launched Cologuard to their internal medicine team in early October. We look forward to working with such a tremendous partner in the fight against colon cancer."

Third-Quarter 2018 Financial Results

For the three-month period ended September 30, 2018, as compared to the same period of 2017 (where applicable):

Revenue was $118.3 million, an increase of 63 percent, and test volume was 241,000, an increase of 49 percent
Average recognized revenue per test was $492, an improvement of 9 percent
Average cost per test was $125, an improvement of 3 percent
Gross margin was 75 percent, an increase of 320 basis points
Operating expenses were $129.2 million, an increase of 61 percent
Net loss was $45.4 million or $0.37 per share, compared to $26.9 million or $0.23 per share
Non-cash interest expense related to convertible debt was $8.4 million, or $0.07 per share
Cash utilization was $36.9 million, compared to $21.7 million
Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter
More than 11,000 healthcare providers ordered their first Cologuard test during the third quarter, and nearly 132,000 have ordered since the test was launched
2018 Outlook

The company anticipates revenue of $435-$440 million for 2018, an increase from prior guidance of $420-$430 million
The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Safe Harbor Statement" section of this press release.

Third-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Tuesday, Oct. 30, 2018, at 5 p.m. ET to discuss third-quarter 2018 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 6870368. The webcast, conference call and replay are open to all interested parties.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2014) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On October 30, 2018 Distributed Bio, the global leader in computational optimization of fully human monoclonal antibody libraries, reported a discovery collaboration with H3 Biomedicine, Inc. designed to help accelerate the discovery of novel cancer therapeutics (Press release, Distributed Bio, OCT 30, 2018, View Source [SID1234530430]). The collaboration will leverage Distributed Bio’s proprietary SuperHuman antibody library platform to discover therapeutic-ready, preoptimized antibodies against H3 Biomedicine targets. H3 Biomedicine is a clinical stage biopharmaceutical company specializing in the discovery and development of next-generation cancer medicines using its data science and precision chemistry product engine.

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"H3 Biomedicine is an exciting oncology company, with a novel approach to uncovering targets that could lead to new treatments for unmet needs in various types of cancer," said Jacob Glanville Ph.D., Co-founder & CSO, Distributed Bio. "What was clear to us from the outset was that H3 Biomedicine’s goals would require significant advances to the normal antibody selection process. At Distributed Bio we are uniquely positioned to provide the advanced selection, screening and engineering techniques needed to advance important discovery programs."

Under the terms of the agreement, Distributed Bio will discover antibodies by screening its SuperHuman antibody library with antigens provide by H3 Biomedicine. Multiple lead antibodies will be identified using a proprietary assay cascade. The antibodies generated through this method will be available to H3 Biomedicine to advance to clinical development. Distributed Bio will receive research funding and the opportunity for future milestone payments.

"At H3 Biomedicine, we are focused on uncovering novel cancer biology and rapidly translating those learnings to advance novel, first-in-class precision oncology medicines. As our lead clinical development programs continue to progress, we are also pursuing a broad portfolio of research programs and targets," said Andrea Gerken, Vice President, Business Development at H3 Biomedicine. "As part of those research efforts, our collaboration with Distributed Bio will enable us to explore H3’s differentiated approach to antibody drug conjugates targeting RNA splicing."

On October 30, 2018 Nektar Therapeutics (Nasdaq: NKTR) reported that it will announce its financial results for the third quarter on Wednesday, November 7, 2018, after the close of U.S.-based financial markets (Press release, Nektar Therapeutics, OCT 30, 2018, View Source [SID1234530449]). Howard Robin, president and chief executive officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time (ET)/2:00 p.m. Pacific Time (PT).

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The press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, December 10, 2018.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 9395678 (Nektar Therapeutics is the host

On October 29, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported that it will report financial results for third quarter 2018 on Tuesday, November 6, 2018 after U.S. financial markets close (Press release, Aclaris Therapeutics, OCT 29, 2018, View Source [SID1234530355]).

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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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Management will conduct a conference call at 5:00 PM ET that day to discuss the Company’s financial results and provide a general business update. A live webcast of the event can be accessed on the Events and Presentations page on the Investors section of the Aclaris website at View Source A replay of the webcast will be archived on the Aclaris website following the event.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 7694929 prior to the start of the call.