On August 27, 2019 Genisphere LLC and University Hospitals Cleveland Medical Center reported a partnership to study and develop unique strategies to treat pancreatic cancer (Press release, Genisphere, AUG 27, 2019, View Source [SID1234539033]). According to their agreement, investigators will optimize 3DNA-based therapeutics designed to target and kill pancreatic tumors. Projects will include delivering a variety of therapeutic cargos, including small molecules and siRNA, formulated with pancreatic tumor-targeting molecules on Genisphere’s 3DNA nanocarrier.

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Jordan Winter, MD, Chief of the Division of Surgical Oncology at University Hospitals Cleveland Medical Center and Director of Surgical Services at UH Seidman Cancer Center, is the lead researcher on the project. He said "My lab studies the harsh, nutrient-deprived microenvironment of pancreatic cancer to exploit metabolic vulnerabilities. By specifically targeting these hypoxic pathways in a multifaceted approach, we can shut down tumor progression. I see our work with Genisphere leading us down a path to the clinic, and commercial development of a lead candidate for the treatment of pancreatic cancer."

Genisphere’s Chief Science Officer, Bob Getts, stated, "We are eager to take the next step from prior data generated together, to investigate alternative strategies for pancreatic cancer treatment. Dr. Winter has strong rationale and evidence for disrupting multiple points along the same biological pathway using different therapeutic molecules and Genisphere has a wide breath of success adapting the 3DNA platform to various modalities: bispecifics, siRNA, small drugs. Therefore we are aligned in this multifaceted strategy and by combining capabilities and expertise we can jointly develop a commercial asset, one will be something we take into the clinic."

On August 27, 2019 ESSA Pharma Inc. (NASDAQ: EPIX; TSXV: EPI) ("ESSA" or the "Company"), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, is reported that, further to its previously announced equity offering, it has closed a public offering of equity securities of the Company in Canada and a concurrent private placement of equity securities in the United States for aggregate gross proceeds of US$36 million (the "Offering") (Press release, ESSA, AUG 27, 2019, View Source [SID1234539032]). The Offering was led by Soleus Capital and included RA Capital Management as a new investor. Existing investors, including BVF Partners LP, Omega Funds, and Eventide Funds, among others, also participated in the Offering.

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The Company intends to use the net proceeds of the Offering primarily to complete the Phase 1 dose-escalation and extension studies, Phase 1 combination studies with recent anti-androgens and initiate Phase II studies. In addition, the Company plans to conduct preclinical studies with EPI-7386 in additional prostate and breast cancer models as well as to continue the development of additional Aniten molecules. According to current plans, the net proceeds combined with the company’s current cash reserves are expected to provide sufficient cash resources through 2022.

The Offering was completed in each of the provinces of British Columbia, Alberta and Ontario by way of a prospectus supplement dated August 23, 2019 to ESSA’s base shelf prospectus dated July 12, 2018 and in the United States on a private placement basis pursuant to Rule 506(c) of Regulation D under the Securities Act of 1933, as amended (the "U.S. Securities Act"). Pursuant to the Offering, ESSA issued a total of 6,080,596 common shares and 11,919,404 pre-funded warrants in lieu of common shares of the Company at a price of US$2.00 per security for aggregate gross proceeds of US$36,000,000. Each pre-funded warrant (together with the common shares, the "Securities") entitles the holder thereof to acquire one common share at a nominal exercise price for a period of 60 months following the closing of the Offering.

The Offering was undertaken on a best efforts basis pursuant to the terms and conditions of an agency agreement (the "Agency Agreement") dated August 23, 2019 between the Company and Bloom Burton Securities, Inc. ("Bloom Burton") as the Company’s sole agent for the Offering in Canada. Oppenheimer & Co. Inc. ("Oppenheimer", together with Bloom Burton, the "Agents") acted as the exclusive U.S. placement agent. The Agents were paid a cash commission equal to 7.0% of the gross proceeds of the Offering (except in respect of Securities issued to certain specified purchasers, in which case the cash commission was reduced to 3.5%).

The issuance of the common shares under the Offering constitutes a related-party transaction under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") due to the participation by certain insiders of the Company. These transactions are exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 pursuant to sections 5.5(a) and 5.7(1)(a) of MI 61-101 as neither the fair market value of any securities issued to nor the consideration paid by such persons exceeds 25.0% of the Company’s market capitalization.

The Securities have not been registered under the U.S. Securities Act or any state securities laws, and accordingly, they may not be offered or sold to, or for the account or benefit of, persons in the United States, or "U.S. persons," as such term is defined in Regulation S promulgated under the U.S. Securities Act ("U.S. Persons"), except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions therefrom.

On August 27, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will be webcasting its corporate presentations at two upcoming investor conferences (Press release, Jazz Pharmaceuticals, AUG 27, 2019, View Source [SID1234539031]).

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Wells Fargo Securities Healthcare Conference in Boston on Wednesday, September 4, 2019 at 8:30 a.m. EDT / 1:30 p.m. IST. Daniel Swisher, president and chief operating officer, will provide an overview of the company and a business and financial update.
Morgan Stanley Annual Global Healthcare Conference in New York on Monday, September 9, 2019 at 8:45 a.m. EDT / 1:45 p.m. IST. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.
A live audio webcast of each presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of each presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

An archive of each webcast will be available for at least one week following each presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.

On August 27, 2019 Penumbra, Inc. (NYSE: PEN) reported that its management team is scheduled to present at the Morgan Stanley 17th Annual Global Healthcare Conference in New York, NY on Tuesday, September 10, 2019 (Press release, Penumbra, AUG 27, 2019, View Source [SID1234539029]).

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Event:

Morgan Stanley 17th Annual Global Healthcare Conference

Date:

Tuesday, September 10, 2019

Time:

1:30pm ET / 10:30am PT

A webcast of the presentation will be available by visiting the investors’ section of the company’s website at www.penumbrainc.com. The webcast will be available on the company’s website for at least two weeks following the event.

On August 27, 2019 Lannett Company, Inc. (NYSE: LCI) reported financial results for its fiscal 2019 fourth quarter and full year ended June 30, 2019 (Press release, Lannett, AUG 27, 2019, View Source [SID1234539028]).

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"In fiscal 2019, we made excellent progress rebuilding our business," said Tim Crew, chief executive officer of Lannett. "We feel positive about our company’s future following a number of significant accomplishments. Since January 2018, we have launched 25 products with annualized sales of approximately $100 million, acquired or in-licensed more than 40 ANDAs and paid down approximately $187 million of our outstanding debt, which included $87 million of voluntary payments. In the past year, we have expanded existing strategic alliances and established new ones, and submitted to the FDA nine product applications, all while we implemented and recently completed a net $33 million cost savings plan.

"Financial results for our fiscal 2019 fourth quarter, the first full quarter of the fiscal year without sales of Levothyroxine, exceeded or were at the upper end of our expectations. The quarter did benefit from a few items that were related to timing.

"Looking ahead, we expect to launch a number of new products that will continue to build our business in the near term and have begun adding products to our pipeline that have significant potential in the medium term and beyond."

For the fiscal 2019 fourth quarter, on a GAAP basis, net sales were $133.8 million compared with $170.9 million for the fourth quarter of fiscal 2018. Gross profit was $49.3 million, or 37% of total net sales, compared with $66.5 million, or 39% of total net sales. Research and development (R&D) expenses were $9.4 million compared with $8.3 million for the fiscal 2018 fourth quarter. Selling, general and administrative (SG&A) expenses were $22.2 million compared with $20.6 million. Restructuring expenses were $2.4 million compared with $4.1 million. Asset impairment charges were $5.9 million compared with $25.0 million for the prior year fourth quarter. Operating income increased to $9.4 million from $8.6 million. Interest expense decreased to $20.2 million from $21.2 million for the fourth quarter of fiscal 2018. Net loss was $7.6 million, or $0.20 per share, compared with $11.4 million, or $0.30 per share, for the fiscal 2018 fourth quarter.

For the fiscal 2019 fourth quarter reported on a Non-GAAP basis, net sales were $133.8 million compared with $170.9 million for the fourth quarter of fiscal 2018. Adjusted gross profit was $59.8 million, or 45% of adjusted net sales, compared with $76.0 million, or 44% of adjusted net sales, for the prior-year fourth quarter. Adjusted R&D expenses were $8.6 million compared with $8.3 million. Adjusted SG&A expenses were $17.0 million compared with $17.4 million. Adjusted operating income was $34.1 million compared with $50.3 million for the prior-year fourth quarter. Adjusted interest expense was $16.0 million compared with $16.6 million for the fourth quarter of fiscal 2018. Adjusted net income was $14.7 million, or $0.37 per diluted share, compared with $24.5 million, or $0.64 per diluted share, for the fiscal 2018 fourth quarter.

For the fiscal 2019 full year, on a GAAP basis, net sales were $655.4 million compared with $684.6 million for the fiscal 2018 full year. Gross profit was $243.6 million, or 37% of total net sales, compared with $288.7 million, or 42% of total net sales. R&D expenses were $38.8 million compared with $29.2 million for the fiscal 2018 full year. SG&A expenses were $87.6 million compared with $82.2 million. Restructuring expenses were $4.1 million compared with $7.1 million. The company reported operating loss of $262.3 million, which included asset impairment charges of $375.4 million. This compares to fiscal 2018 full year operating income of $129.7 million, which included asset impairment charges of $25.0 million and a loss on sale of intangible asset of $15.5 million. Interest expense decreased to $84.6 million from $85.6 million. Net loss was $272.1 million, or $7.20 per share, versus net income of $28.7 million, or $0.75 per diluted share, for fiscal 2018.

For the fiscal 2019 full year reported on a Non-GAAP basis, net sales were $655.4 million compared with $684.6 million for the fiscal 2018 full year. Adjusted gross profit was $291.4 million, or 44% of adjusted net sales, compared with $326.2 million, or 48% of adjusted net sales, for the prior year. Adjusted R&D expenses were $36.1 million compared with $29.2 million. Adjusted SG&A expenses were $71.2 million compared with $71.0 million. Adjusted operating income was $184.1 million compared with $226.0 million for the prior year. Adjusted interest expense was $67.0 million compared with $65.4 million for fiscal 2018. Adjusted net income was $91.8 million, or $2.35 per diluted share, compared with $118.2 million, or $3.10 per diluted share, for the fiscal 2018 full year.