On February 18, 2021 Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, reported that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering (Press release, Veru, FEB 18, 2021, View Source [SID1234575305]). Veru intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Jefferies is acting as the sole book-running manager for the offering.

Veru intends to use the net proceeds of the proposed offering for research and development, clinical trial, regulatory, and sales and marketing expenditures, and for working capital and other general corporate purposes.

The offering is being made by Veru pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) on June 26, 2020 and declared effective by the SEC on July 1, 2020. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 18, 2021 Nordic Nanovector ASA (OSE: NANOV) reported an update on PARADIGME, its ongoing pivotal Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line relapsed/refractory follicular lymphoma (3L R/R FL) (Press release, Nordic Nanovector, FEB 18, 2021, View Source [SID1234575300]).

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Despite COVID has the company seen a significant improvement in the enrolment rate from approximately two to approximately five patients per month. After the expected lessening of COVID restrictions plus the ongoing operational improvements, this rate could further increase to at least seven patients on average per month by late spring.

14 patients were enrolled from November 2020 to 17 February 2021 (three patients from August to November 2020), with visibility on increasing numbers of patients in screening. 73 patients were enrolled as of 17 February 2021 (59 enrolled as of 18 November 2020).

In addition, following discussions with the US Food and Drug Administration and an internal review, the company believes that a robust clinical data set (safety and efficacy) to support a filing at the designated dosing regimen of 40/15 can be achieved with a reduction of the initially targeted population from 130 to 120 patients. On this basis, 47 more patients are required to complete PARADIGME for regulatory submission of Betalutin.

The trial protocol amendments that were submitted in Q3’2020 have now been approved in all of the 24 participating countries including the US. In addition, further initiatives have been implemented, especially in the US, to improve the enrolment rate by entering agreements with organisations that specialise on focused patient enrolment campaigns.

The recent improvement in the enrolment rate has been driven by these protocol amendments and the initiatives being implemented to facilitate trial execution. The company anticipates the enrolment rate to continue improving as the most recent initiatives pay back fully and the impact of COVID-19 recedes with restrictions lifting over time as the roll out of global vaccination programmes takes effect.

As a result, the company is more confident that it can deliver preliminary three-month top-line data from PARADIGME in H2’2021.

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, commented: "We are beginning to see an encouraging improvement in the enrolment rate for PARADIGME based on changes to the trial protocol and the initiatives we are implementing to improve the execution of the trial. We now have clarity from key regulators on the clinical data set that is expected as a basis for our filing. This clarity, in conjunction with the improving enrolment rate and the continuing recruitment initiatives, gives us confidence that we can meet our goal of having preliminary three-month top-line data in H2′ 2021."

On February 18, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell–based protein expression system, reported it has completed a raise bringing in gross proceeds of approximately $40 million, before deducting the underwriting discount and estimated expenses of the offering (Press release, Protalix, FEB 18, 2021, View Source [SID1234575299]). BofA Securities acted as book-running manager for the offering with Oppenheimer & Co. acting as co-manager.

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"I am very proud of our team for all our accomplishments this past year, especially having executed on our strategic plans during the global pandemic. We are on a new trajectory as a company with the potential upcoming commercial launch in a significant market with a new, exciting treatment option for patients, if approved; a pipeline of proprietary assets designed to enhance shareholder value supported by a strong balance sheet allowing us to execute on our strategic goals," said Dror Bashan, President and Chief Executive Officer of Protalix.

Eyal Rubin, Chief Financial Officer of Protalix added, "With this financing, we were able to accomplish our goal of bringing in new institutional investors to the Company while strengthening our balance sheet to accelerate clinical trial development. We are grateful for the commitment and the confidence in our strategic plans and goals and look forward to continuing to execute and achieve our milestones planned for this year."

Protalix intends to use the net proceeds from the offering to fund clinical trials for its product candidates, to fund its research and development activities and for working capital and other general corporate purposes.

On February 18, 2021 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a virtual fireside chat at the SVB Leerink Global Healthcare Conference on Wednesday, Feb. 24, 2021 at 9:20 a.m. ET (2:20 p.m. GMT) (Press release, Alkermes, FEB 18, 2021, View Source [SID1234575298]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On February 18, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a late-stage targeted oncology company, reported that it will participate in two upcoming healthcare conferences (Press release, Mirati, FEB 18, 2021, View Source [SID1234575297]).

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Friday, February 26th at 12:00 p.m. EST/9:00 a.m. PST at the 10th Annual SVB Leerink Global Healthcare Conference. Dan Faga, executive vice president and chief operating officer will represent Mirati in a fireside chat at the conference.
Wednesday, March 3rd at 2:00 p.m. EST/11:00 a.m. PST at the 41st Annual Cowen Healthcare Conference. Charles M. Baum, M.D., Ph.D., president and chief executive officer will represent Mirati in a fireside chat at the conference.
The webcast will be available through the "Investors" section of the Mirati website, Mirati Investor Events and Presentations, and a replay of the webcast will be made available for 90 days following the event.