On December 19, 2019 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, reported that preliminary revenue estimates for its recently completed fiscal year 2019 and revenue guidance for fiscal year 2020 (Press release, Theratechnologies, DEC 19, 2019, View Source [SID1234552510]).

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Theratechnologies expects to report consolidated revenues of approximately US$63.3 million for fiscal year 2019 compared to US$45.2 million for the previous year, representing an increase of approximately 40%.

Consolidated revenues of approximately US$16.5 million for the fourth quarter of 2019 represent an increase of 17.7% compared to Q4 of 2018, and 2.1% compared to Q3 2019.

Fourth quarter net sales of Trogarzo (ibalizumab-uiyk, injection) are expected to be approximately US$7.7 million, an increase of approximately 81% compared to the same quarter of 2018 and approximately 11.3% compared to Q3 of this year.

Net sales of EGRIFTA are expected to be approximately US$8.7 million for the fourth quarter of 2019, a decrease of 10% compared to the same quarter of 2018 and of 4.8% compared to Q3 of this year. Although unit sales actually increased 5.3% compared to both Q4 2018 and Q3 2019, net sales for Q4 2019 were impacted by an unexpected charge related to government rebates not previously recorded by one of our distributing pharmacies. A portion of units sold to this pharmacy were previously incorrectly identified by the pharmacy as commercial patients, when they were actually government reimbursed patients, who are eligible to rebates.

"Our fiscal year 2019 was one of growth and transition. Our revenues grew strongly, and we rebuilt our research pipeline. In 2020, we will implement numerous new marketing initiatives for Trogarzo in the US, and plan to start the commercialization of this product in Europe. We are also confident that the recent launch of EGRIFTA SVTM will spark renewed interest and momentum for this product for the coming years. On the R&D front, we plan to start, by the end of 2020, a Phase III trial for the treatment of NASH in HIV patients and a Phase I trial for our novel oncology platform," said Luc Tanguay, President and CEO, Theratechnologies Inc.

2020 revenue guidance

Theratechnologies expects revenues to reach between US$83 to US$87 million in 2020. This would represent a 31 to 37 percent increase from fiscal year 2019.

The Company still expects to maintain a solid cash position as the estimated growth in revenue will generate enough cash to fund its operations and its clinical research programs in 2020.

"We intend to remain focused on implementing our strategic plan rigorously and to make 2020 a pivotal year for the Company from a revenue perspective while also continuing to build the future of our Company through the development of our promising pipeline. This Company is stronger than it has ever been, and we know that we can accomplish our ambitious yet realistic strategic plan," concluded Mr. Tanguay.

On December 19, 2019 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that a planned review by an independent Data Safety Monitoring Board (DSMB) has analyzed safety data from ten weeks of treatment of the first patient enrolled in the NOX-A12 plus radiotherapy brain cancer trial (Press release, NOXXON, DEC 19, 2019, View Source [SID1234552530]). Based on this assessment, the DSMB has confirmed that it is appropriate to continue the recruitment of additional patients according to the study protocol.

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The clinical trial centers participating in the study have therefore initiated the recruitment of the remaining patients in the first of three escalating dose groups. Once each patient in the first cohort has received a four-weeks treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to proceed to the middle dose level of NOX-A12.

"We are encouraged by this initial confirmation of the safety profile of NOX-A12," commented Aram Mangasarian, CEO of NOXXON. "Following this analysis, the trial can progress as planned so the next patients can receive the treatment as part of the protocol. We remain focused on reaching our goal of obtaining data from the first cohort of patients in mid-2020, and from the second and third cohorts in the fourth quarter 2020 and the second quarter of 2021, respectively."

On December 19, 2019 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will announce results for the fourth quarter of 2019 on Thursday, February 6, 2020 (Press release, Bristol-Myers Squibb, DEC 19, 2019, View Source [SID1234552493]). During a conference call at 8:30 a.m. ET on February 6, 2020, company executives will review financial information and will address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 888-204-4368 or international 786-789-4797, confirmation code: 5605395. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 11:45 a.m. ET on February 6 through 11:45 a.m. ET on February 20, 2020. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 5605395.

On December 19, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the 38TH Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 12:00 pm PT in San Francisco (Press release, Ultragenyx Pharmaceutical, DEC 19, 2019, View Source [SID1234552511]).

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The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On December 19, 2019 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, reported that it has entered into definitive agreements to sell securities in a private placement with a group of institutional investors and certain members of the Company’s Board of Directors (Press release, Selecta Biosciences, DEC 19, 2019, View Source [SID1234552494]). The lead institutional investors in the private placement were Vivo Capital LLC, Mangrove Partners, EcoR1 Capital LLC, BVF Partners L.P., and Boxer Capital LLC. The transaction is expected to result in gross proceeds to the company of approximately $70 million, before deducting placement agent fees and other offering expenses.

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The Company plans to use the net proceeds from the financing primarily to fund the ongoing head-to-head Phase 2 COMPARE clinical trial of its lead product candidate, SEL-212, for the treatment of chronic refractory gout, its gene therapy programs, and for general corporate purposes.

Pursuant to the terms of the securities purchase agreement, the Company will issue 45,977,011 units at a price of approximately $1.5225 per unit. Each unit consists of approximately one share of common stock and a warrant to purchase 0.5 of a share of common stock at an exercise price of $1.46. Certain institutional investors have elected to receive pre-funded warrants to purchase common stock in lieu of a portion of their common stock. The closing of the offering is subject to certain conditions and is expected to occur on Monday, December 23, 2019.

Cantor Fitzgerald & Co. served as placement agent for the offering.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and will be sold in a private placement pursuant to Regulation D of the Securities Act. The securities being issued in the private placement may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. The Company has agreed to file a registration statement covering the resale of the securities acquired by the investors in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.