On April 18, 2019 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, Apr. 25, 2019, to discuss the company’s first quarter 2019 financial results (Press release, Alkermes, APR 18, 2019, View Source;p=RssLanding&cat=news&id=2395048 [SID1234535197]). Management will also provide an update on the company.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, Apr. 25, 2019, through Thursday, May 2, 2019, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13690081.

On April 18, 2019 VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, reported that the Company will present an abstract about the design of its ongoing trial in patients with glioblastoma with VXM01 oral T-cell immunotherapy in combination with the anti-PD-L1 checkpoint inhibitor avelumab at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Vaximm, APR 18, 2019, View Source [SID1234535195]).

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2019 ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) Annual Meeting
May 31 – June 4, 2019
Chicago, IL, USA

The abstract (#269161) "Oral DNA vaccination targeting VEGFR-2 combined with anti-PD-L1 avelumab in patients with progressive glioblastoma, a phase I/II study: NCT03750071" will be presented during Poster Session: Central Nervous System Tumors, on June 2, 2019, 8:00 AM-11:00 AM CDT. The abstract will be available online on May 15, 2019 at 5 PM EDT at View Source

Additionally, the Company will participate in several other industry and scientific events in the second quarter of 2019.

European Neoantigen Summit
April 23 – 25, 2019
Amsterdam, The Netherlands

VAXIMM representatives will be available for one-on-one meetings during the summit. To schedule a meeting with VAXIMM, please contact [email protected].

Bio€quity Europe
May 20 – 21, 2019
Barcelona, Spain

Dr. Heinz Lubenau, Chief Operating Officer of VAXIMM, will give a corporate presentation. The Company will also host one-on-one meetings at this event. To request a meeting with VAXIMM, please sign up through the event’s meeting system.

17th CIMT (Free CIMT Whitepaper) (Association for Cancer Immunotherapy) Annual Meeting
May 21 – 23, 2019
Mainz, Germany
VAXIMM representatives will be available for one-on-one meetings during the event. To schedule a meeting with VAXIMM, please contact [email protected].

On April 18, 2019 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported Q1 2019 operational highlights, revenue and cash position for Nicox and its subsidiaries (the "Nicox Group"), as well as key upcoming milestones (Press release, NicOx, APR 18, 2019, View Source [SID1234535194]).

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Michele Garufi, Chairman and Chief Executive Officer of Nicox, said, "With two exciting programs in advanced clinical development and two products approved in the U.S. we are continuing apace to fully leverage our scientific, clinical, and commercial assets. Enrollment has now reached over 85% in the NCX 470 glaucoma clinical trial, and both this and the NCX 4251 blepharitis trial should generate topline results in Q4 of this year. We expect our recurrent revenues to ramp up as Bausch + Lomb progresses the international rollout of VYZULTA, and with the launch by Eyevance of ZERVIATE in the U.S. In addition, our ongoing discussions for ZERVIATE outside of the U.S. could result in agreements in the near future with further upfront, milestone and royalty payments."

Key Upcoming Milestones
NCX 470 Phase 2 results: Top-line data from the NCX 470 Phase 2 clinical trial for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension expected in Q4 of this year.
NCX 4251 Phase 2 results: Phase 2 clinical trial in patients with acute exacerbations of blepharitis ongoing with top-line data expected in Q4 of this year.

ZERVIATE U.S. launch: Commercial launch of ZERVIATE (cetirizine ophthalmic solution), 0.24% in the U.S. planned by our partner Eyevance Pharmaceuticals for summer of this year. Nicox eligible for up to $3 million of a potential future milestone payment from Eyevance related to certain regulatory and near-term manufacturing objectives, which are expected to be received prior to the U.S. launch.

ZERVIATE ex-US partnering: Multiple discussions ongoing for potential new licensing agreements in significant markets.
Nicox’s ophthalmology programs to be presented at key scientific conferences including the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
First Quarter 2019 and Recent Operational Highlights
The total number of prescriptions for VYZULTA in the U.S. in the first quarter of 2019 increased by 18% compared to Q4 20181 and by 360% compared to the first quarter 20181.
On March 19, 2019, we announced the initiation of a Phase 2 clinical trial evaluating NCX 4251, our novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis. We expect to report top-line results from this Phase 2 trial in the fourth quarter of 2019.
On March 15, 2019, we announced that we had we entered into an exclusive license agreement with Ocumension Therapeutics for the development and commercialization of Nicox’s product ZERVIATE (cetirizine ophthalmic solution), 0.24% for the treatment of allergic conjunctivitis for the Chinese market.
On January 25, 2019, we announced that we had entered into a bond financing for up to €20 million from Kreos Capital. The financing is structured as three tranches of which only the first tranche of €8 million has been drawn down. The exercise of the two other tranches is at Nicox’s sole discretion.
On January 8, 2019 we announced that we had reached the 50% patient enrollment threshold of our multicenter, U.S. Phase 2 clinical trial evaluating our lead product candidate, NCX 470, ahead of schedule. NCX 470 is a novel, second-generation nitric oxide (NO)-donating prostaglandin analog for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension that has demonstrated 2 to 3 mmHg superior IOP lowering vs. the U.S. market leader LUMIGAN in head-to-head preclinical evaluations.
Also in January, our global partner, Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies, Inc., received approval in Canada of VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%. VYZULTA is indicated for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension.
First Quarter 2019 Financial Highlights
As of March 31, 2019, the Nicox Group had cash and cash equivalents of €23.5 million as compared with €22.0 million at December 30, 2018. Net revenue2 for the first quarter of 2019 was €0.430 million versus €0.075 million in the first quarter of 2018.

On April 18, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that the U.S. Food and Drug Administration ("FDA") has approved its request for Fast Track Designation for its drug, Annamycin, for the treatment of relapsed or refractory acute myeloid leukemia ("AML") (Press release, Moleculin, APR 18, 2019, View Source [SID1234535192]).

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"We are thrilled that Annamycin has been granted Fast Track Designation," commented Walter Klemp, Moleculin’s Chairman and CEO. "Not only does this make us eligible for accelerated approval and priority review, but it serves as an important validation of the significant unmet need we are trying to address. Currently, Annamycin is in separate Phase I/II trials in the U.S. and Europe for the treatment of AML and the Company has recently announced positive interim top line data."

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

On April 18, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported the pricing of an underwritten public offering of 42,860,000 shares of its common stock at a combined public offering price of $0.385 per share of common stock (Press release, Actinium Pharmaceuticals, APR 18, 2019, View Source [SID1234535191]). The Company also announced the pricing of warrants to purchase up to 42,860,000 shares of common stock at an exercise price of $0.50 per share and with a term of 5 years commencing on the date of issuance. The offering is expected to close on or about April 23, 2019, subject to the satisfaction of customary closing conditions. The gross proceeds to Actinium from this offering are expected to be $16.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Actinium. Actinium intends to use the net proceeds from the sale of the common stock and warrants to fund its ongoing pivotal, Phase 3 SIERRA trial for its lead product candidate Iomab-B and progress Phase 1 trials from its refocused CD33 program to the proof of concept stage. Actinium will also use the proceeds to support its antibody warhead enabling technology platform, including its Iomab-ACT program, research and development and general working capital needs.

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William Blair & Company, L.L.C. is acting as sole bookrunner for the offering.

The shares and warrants are being offered pursuant to an effective shelf registration statement (including a prospectus) on Form S-3 (File No. 333-216748) filed with the U.S. Securities Exchange Commission (the "SEC"). A preliminary prospectus supplement, dated April 17, 2019 and accompanying prospectus, dated October 24, 2017, relating to the offering have been filed with the SEC. To obtain a copy of the preliminary prospectus supplement, dated April 17, 2019, and the final prospectus supplement (when available) for this offering, please contact William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, or by calling (800) 621-0687, or emailing [email protected].

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