Selecta Biosciences to Present at the Canaccord Growth Conference on August 9, 2018

On August 2, 2018 Selecta Biosciences, Inc. (Nasdaq:SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that CFO and Head of Corporate Strategy John Leaman, M.D., will be present at the Canaccord Genuity 38th Annual Growth Conference in Boston, Mass. at 2 p.m. ET on Thursday, August 09, 2018 (Press release, Selecta Biosciences, AUG 2, 2018, View Source [SID1234528384]). A live and archived webcast of the presentation will be available on the Investors & Media section of the Selecta website at www.selectabio.com.

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Omeros Hires Former Sanofi Global Development Head as Chief Medical Officer

On August 2, 2018 Omeros Corporation (Nasdaq: OMER) reported that Eckhard Leifke, M.D. has been named Omeros’ Chief Medical Officer and Vice President of Clinical Development (Press release, Omeros, AUG 2, 2018, View Source;p=RssLanding&cat=news&id=2361629 [SID1234528382]). In this role, Dr. Leifke will oversee clinical science & operations, medical affairs and pharmacovigilance. He assumes these corporate responsibilities from J. Steven Whitaker, M.D., J.D., Vice President of Clinical Development, who will now focus primarily on driving the clinical aspects of Omeros’ MASP-2 antibody – OMS721 – toward U.S. and international regulatory approvals in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

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"I am excited to join Omeros’ leadership team," said Dr. Leifke. "I am impressed by the quality of Omeros’ pipeline and by the sense of urgency within the company to advance these programs to improve the lives of patients. With input from thought leaders and their patients who are affected by the serious conditions for which Omeros is developing novel therapeutics, my top priority is to continue accelerating the company’s clinical programs toward successful commercialization."

Dr. Leifke brings to Omeros more than 20 years of drug development experience, having built and headed global teams at leading pharmaceutical companies including Bayer, Takeda and, most recently, Sanofi where he was Global Project Head/Vice President of Early Project & External Opportunities – Cardiovascular and Metabolism and Global Head/Vice President of Late-Stage Development Diabetes. He has led the global development of multiple early- and late-stage small-molecule and biologic drug candidates to successful market authorizations in the USA, Europe, Japan and other countries.

"We’re pleased to welcome Eckhard to our senior leadership team, and I expect that his proven track record and thoughtful approach to strategic drug development globally will be valuable assets for Omeros," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "This important and timely expansion of our clinical team underscores Omeros’ progress and our longstanding commitment to providing cutting-edge therapeutics to patients with disabling and life-threatening disorders. I’d like to recognize Steve Whitaker for his ongoing exemplification of that same commitment, and I look forward to his leading OMS721 to a successful outcome in stem-cell TMA, currently one of Omeros’ highest priorities."

Dr. Leifke holds a Medical Doctorate from the University of Freiburg, Germany, and is Board-certified in Internal Medicine and Endocrinology.

MannKind Corporation Reports 2018 Second Quarter Financial Results Conference Call to Begin Today at 5:00 PM ET

On August 2, 2018 MannKind Corporation(NASDAQ:MNKD) reported financial results for the second quarter ended June 30, 2018 (Press release, Mannkind, AUG 2, 2018, View Source [SID1234528381]).

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"In 2Q 2018, we experienced our highest Afrezza sales ever due to increased physician trial and adoption. We have doubled our market share over the past year as a result of our commercialization efforts and are excited about our new Afrezza clinical data being released throughout 2018. Additionally, Treprostinil Technosphere (TreT) continues to progress towards Phase 3 and may address an important unmet need for those living with pulmonary arterial hypertension,"said Michael Castagna, Chief Executive Officer of MannKind Corporation.

Second Quarter Results

For the second quarter of 2018, Afrezza net revenue was $3.8 million, an increase of 142% compared to $1.5 million for the second quarter of 2017 resulting from increased volume, price, and favorable cartridge mix. On January 1, 2018, we adopted ASC 606, the new revenue recognition standard, under which we recognize revenue as we sell product to wholesale distributors; revenue for prior periods is recognized on the basis of a model that estimates the sale of Afrezza to patients.

Cost of goods sold remained level for the three months ended June 30, 2018 at $5.0 million compared to the same period in 2017. Lower inventory write-offs offset an increase in cost of goods sold resulting from higher Afrezza sales and excess capacity costs.

Research and development (R&D) expenses for the second quarter of 2018 were $2.9 million compared to $3.1 million for the second quarter of 2017, a decrease of $0.2 million or 5%, reflecting $0.7 million in lower salary related expenses for personnel who were engaged in research and development activities in 2017 who have transitioned to Afrezza medical affairs activities and a $0.3 million decrease in repairs and maintenance on laboratory equipment, offset by a $0.9 million increase in clinical trial costs.

Selling, general and administrative (SG&A) expenses were $21.7 million for the second quarter of 2018 compared to $18.6 million for the second quarter of 2017. The $3.1 million, or 17%, increase was primarily due to a $1.0 million increase in non-cash stock compensation expenses, a $0.8 million increase in consulting fees, a $0.6 million increase in costs related to transitioning certain corporate support functions from Connecticut to our corporate headquarters in California, and a $0.6 million increase in relocation spending for key personnel.

The net loss for the second quarter of 2018 was $22.7 million, or $0.16 per share, compared to the $35.3 million net loss in the second quarter of 2017 or $0.35 per share.

Six Months Ended Results

For the six months ended June 30, 2018, Afrezza net revenue was $7.2 million, an increase of 161% compared to $2.7 million for the same period in 2017 (prior to the adoption of ASC 606).

Cost of goods sold for the six months ended June 30, 2018 was $9.1 million compared to $7.6 million for the six months ended June 30, 2017, an increase of $1.5 million or 19%. This increase was due to the result of higher Afrezza sales of $0.8 million and $1.0 million increase of excess capacity costs. These increases were partially offset by lower inventory write-offs compared to the same period in 2017.

R&D expenses for the six months ended June 30, 2018 were $5.6 million compared to $6.3 million for the six months ended June 30, 2017, a decrease of $0.7 million or 11%, reflecting $0.9 million in lower salary related expenses for personnel who were engaged in research and development activities in 2017 but transitioned to Afrezza medical affairs activities, offset by a $0.3 million increase in clinical trial costs.

SG&A expenses were $42.3 million for the six months ended June 30, 2018 compared to $34.0 million for the six months ended 2017. The $8.3 million or 24% increase was primarily due to a $1.7 million increase in additional headcount-related expenses associated with sales personnel hired in 2018, a $1.1 million increase in additional headcount-related expenses in our human resources, accounting, corporate communications, and office support departments, a $1.7 million increase in non-cash stock compensation expense, a $1.3 million increase in employee benefits, a $1.2 million increase in costs related to transitioning certain corporate support functions from Connecticut to our corporate headquarters in California, and a $0.9 million increase in consulting fees.

The net loss for the six months ended June 30, 2018 was $53.1 million, or $0.41 per share, compared to a $51.7 million for the six months ended June 30, 2017, or $0.53 per share.

Cash and Cash Equivalents

Cash, cash equivalents and restricted cash at June 30, 2018 decreased to $26.7 million compared to $48.4 million at December 31, 2017, primarily due to net cash used in operating activities of $48.8 million in 2018 primarily offset by $26.4 million of net proceeds from a registered direct offering of 14 million shares of common stock and warrants at a purchase price of $2.00 per share and accompanying warrant.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. To view and listen to the earnings call webcast live via the Internet, visit the Company’s website at www.mannkindcorp.com and click on the "Q2 2018 MannKind Earnings Conference Call" link in the Webcasts section of News & Events. To participate in the live call by telephone, please dial (800) 239-9838 toll-free or (323) 794-2551 toll/international and use the conference passcode: 5195402.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 toll-free or (412) 317-6671 toll/international and use the replay passcode: 5195402. A replay will also be available on MannKind’s website for 14 days.

Karyopharm to Participate in Upcoming Investor Conferences

On August 2, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that members of the Company’s management team will participate in the following upcoming investor conferences (Press release, Karyopharm, AUG 2, 2018, View Source [SID1234528380]):

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The Canaccord Genuity 38th Annual Growth Conference on Thursday, August 9, 2018 at 1:00 p.m. ET.

The 2018 Wedbush PacGrow Healthcare Conference on Tuesday, August 14, 2018 at 8:00 a.m. ET.

A live webcast of each of these events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of each webcast will be archived on the Company’s website for 90 days following the presentation.

Intrexon to Announce Second Quarter and First Half 2018 Financial Results on August 9th

On August 2, Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release second quarter and first half 2018 financial results after the market closes on Thursday, August 9th, 2018 (Press release, Intrexon, AUG 2, 2018, View Source [SID1234528379]). The Company will host a conference call that day at 5:30 PM ET to discuss the results and provide a general business update.

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 6027271 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source