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Nicox Announces 2019 Financial Results and 2020 Key Milestones

On March 6, 2020 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported the financial and operating results for Nicox and its subsidiaries (the "Nicox Group") for the year ended December 31, 2019, as approved by the Board of Directors on March 5, 2020, and provided upcoming 2020 key milestones (Press release, NicOx, MAR 6, 2020, View Source [SID1234555261]).

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2019 Financial Summary
Net revenue1 for the full year 2019 was €6.9 million (€2.1 million in net royalties, €4.8 million in upfront and milestone payments), compared to €4.0 million (€1 million in net royalties and €3 million in an upfront payment) for the full year 2018.

Operating expenses for the period 2019 decreased to €25.5 million from €26.5 million for the 12 months to December 31, 2018. Research and development expenses increased by €1.4 million reflecting the investments in the successful clinical trials for NCX 470 and NCX 4251 while administrative and other expenses decreased by €2.4 million.

Net loss of the Nicox Group for the full year 2019 was €18.9 million against €18.4 million in the full year 2018.

As of December 31, 2019, the Nicox Group had cash and cash equivalents of €28.1 million as compared with €22.1 million at December 31, 2018. The December 31, 2019 cash position does not include the last tranche of loan under the bond financing agreement with Kreos Capital which was drawn down in December 2019 but received on January 2, 2020, adding approximately €7.7 million to the year-end cash position of the Group.

As of December 31, 2019, the Nicox Group had a financial debt of €11.1 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 adjusted to approximately €18.8 million by including the last tranche of loan drawn down in December 2019.

Events after the Reporting Period
Nicox successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) (see Press Release of March 5, 2020). The Mont Blanc trial, the first Phase 3 clinical trial of NCX 470, is expected to start by the end of Q2 2020, with top-line results expected in Q3 2021. The Mont Blanc trial will be initiated with 0.065% and 0.1% doses of NCX 470, with one dose being selected during the trial through an adaptive design.
Nicox received approval from the U.S. Patent and Trademark Office of a formulation patent for NCX 470, extending the U.S. patent coverage to 2039 (see Press Release of February 3, 2020). Nicox has also received approval of this patent in Japan.
Nicox presented NCX 470 Dolomites Phase 2 results at the Glaucoma 360 New Horizons Forum (February 7, 2020) and at the American Glaucoma Society (AGS) Annual Meeting (February 27 – March 1, 2020). NCX 4251 Danube Phase 2 results were also presented at AGS.
Nicox’s research activities are being concentrated on nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitors program for glaucoma for which we expect to be able to announce an Investigational New Drug (IND)-track candidate in 2020 and therefore we are terminating our research collaboration with Cyclerion Therapeutics, Inc.
We strengthened our Clinical Development function by appointing Kristie Veasey to the position of Director Clinical Operations, effective March 2, 2020. Reporting to Dr. José Boyer, Vice President of Clinical Development, Ms. Veasey will be responsible for leading clinical operations for some of our upcoming clinical trials. She brings over 19 years of experience in clinical research and development in both the Pharmaceutical Industry and Clinical Research Organizations, with the majority of her professional experience in the therapeutic area of ophthalmology including at Lexitas Pharma Services, Clearside Biomedical and Inspire Pharmaceuticals, Inc.
Key Expected Upcoming Milestones
NCX 470 Phase 3 clinical trial preparation: Phase 3 clinical trial (‘Mont Blanc’) is expected to be initiated by the end of Q2 2020.
NCX 4251: Meeting with the U.S. FDA is scheduled in Q1 2020 to discuss the next steps of the clinical development plan.
ZERVIATETM U.S. launch: Commercial launch of ZERVIATETM (cetirizine ophthalmic solution), 0.24% in the U.S. is planned by Nicox’s partner Eyevance Pharmaceuticals in H1 2020.
Presentations on Nicox’s ophthalmology research and development programs at key U.S. scientific conferences including the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting and the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.

Immunowake Announces Licensing Agreements with GenSci and GenScript

On March 5, 2020 Immunowake Inc. reported that it has entered into agreements with Genescience Pharmaceuticals Co., Ltd and Genscript Biotech Corp (HKG: 1548) in which Immunowake will obtain exclusive licenses to PD-L1 antibodies for the development of multi-target therapeutics. Terms of the agreement were not disclosed (Press release, Immunowake, MAR 5, 2020, View Source [SID1234656119]).

Immunowake is a pre-clinical company focused on the development of antibody-based therapeutics against cancer. Immunowake’s CEO and founder Xiaoyun Wu said, "This agreement provides us the necessary resources to continue to pursue multiple, non-exclusive research collaborations, as well as future financing opportunities."

INmune Bio, Inc. to Present at the 32nd Annual ROTH Conference on March 17

On March 5, 2020 INmune Bio, Inc., an immunology company developing treatments that harness the patient’s innate immune system to fight disease, reported that management will present at the 32nd Annual Roth Conference at 8:30 a.m. (PT) on Tuesday, March 17, 2020 and will conduct one-on-one meetings that day (Press release, INmune Bio, MAR 5, 2020, View Source [SID1234555321]).

The conference will be held March 15-17, 2020 at The Ritz Carlton, Laguna Niguel in Orange County, CA. The ROTH Conference, with close to 550 participating companies and over 5,100 attendees, will feature presentations from public and private companies in a variety of sectors.

Management will be available for one-on-one meetings. For more information about the conference or to schedule a one-on-one meeting with management, please contact [email protected].

Entry into a Material Definitive Agreement.

On March 5, 2020, XOMA (US) LLC (the "Company" or "XOMA"), a wholly-owned subsidiary of XOMA Corporation, reported that it has entered into a Collaboration and License Agreement (the "Agreement") with Cadila Healthcare Limited ("Zydus"), a company organized and existing under the laws of India, effective as of March 3, 2020 (Filing, 8-K, Xoma, MAR 5, 2020, View Source [SID1234555316]). Pursuant to the Agreement, the Company acquired the rights to receive potential royalty payments in the single to low double-digit percentages of the aggregate net sales in India, Brazil, Mexico and certain other emerging markets (the "Zydus Territory") associated with an IL-2-based immuno-oncology drug candidate that combines Zydus’s IL-2 candidate with XOMA’s anti-IL-2 monoclonal antibody (the "Drug Candidate"). Pursuant to the Agreement, Zydus will make certain development, regulatory and commercial milestone payments to the Company in the potential aggregate amount of up to $24 million upon the occurrence of certain events as set forth in the Agreement and share with the Company revenue received from third party sublicensees in the Zydus Territory. Zydus will be solely responsible for the development of the Drug Candidate through the first Phase 2 clinical study at its sole cost.

Subject to a right of first negotiation granted to Zydus to acquire rights to the Drug Candidate world-wide outside of the Zydus Territory (the "XOMA Territory"), which expires 180 days following the completion of the Drug Candidate’s first Phase 2 clinical study, the Company retains the rights to develop and commercialize the Drug Candidate in the XOMA Territory itself or through one or more third party sublicensees. The Company’s development and commercialization of the Drug Candidate in the XOMA Territory would be subject to the payment of low to mid teen-digit royalties to Zydus on the aggregate net sales of the Drug Candidate, or sharing with Zydus revenue received from third party sublicensees.

Unless earlier terminated, the Agreement will remain in effect until the expiration of all payment obligations by either party with respect to the Drug Candidate. The Agreement may be terminated (i) by mutual agreement, (ii) by either party for the other party’s uncured material breach, bankruptcy or competitive change of control, (iii) by Zydus prior to expiration of its right of first negotiation due to safety or technical infeasibility or (iv) by Zydus following expiration of its right of first negotiation for convenience upon 90 days prior notice if prior to the first commercial sale of the Drug Candidate in the Zydus Territory or upon 180 days prior notice if after such first commercial sale.

The description of the Agreement contained herein does not purport to be complete, and is qualified in its entirety by reference to such Agreement, together with the exhibits thereto, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending March 31, 2020.

Termination of a Material Definitive Agreement

On March 5, 2020, Celsion Corporation (the "Company") reported to Aspire Capital Fund, LLC, an Illinois limited liability company ("Aspire Capital"), terminating the Common Stock Purchase Agreement dated October 28, 2019 (the "2019 Aspire Purchase Agreement") with Aspire Capital effective as of March 6, 2020. The 2019 Aspire Purchase Agreement provided that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital was committed to purchase up to an aggregate of $10 million of shares of the Company’s common stock over the 24-month term of the 2019 Aspire Purchase Agreement at a price equal to (i) the lowest sale price of the Company’s common stock on the purchase date; or (ii) the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive trading days ending on the trading day immediately preceding the purchase date (Filing, 8-K, Celsion, MAR 5, 2020, View Source [SID1234555303]). In consideration for entering into the 2019 Aspire Purchase Agreement, the Company issued to Aspire Capital 100,000 shares of the Company’s common stock.

On November 8, 2019, the Company filed with the SEC a Registration Statement on Form S-1 registering all the shares of common stock that may be offered to Aspire Capital from time to time under the 2019 Aspire Purchase Agreement. From October 28, 2019 through the date of termination, the Company sold 1,500,000 shares of common stock under the 2019 Aspire Purchase Agreement generating proceeds of $2.3 million. Upon termination, the Company has no further obligations under the 2019 Aspire Purchase Agreement.