On July 17, 2020 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported Q2 2020 operational highlights, revenue and cash position for Nicox SA and its subsidiaries (the "Nicox Group"), as well as updating key expected milestones for the remainder of 2020 (Press release, NicOx, JUL 17, 2020, View Source [SID1234562025]).

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Key Expected Upcoming Milestones
NCX 470 Mont Blanc Phase 3 clinical trial: The adaptive design part of the first Phase 3 clinical trial of NCX 470 for lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension is on track to be completed in Q4 2020, facilitating both the start of the second Phase 3 "Denali" trial on schedule and the completion of the Mont Blanc trial where patients will then continue on the selected NCX 470 dose in the subsequent head-to-head 3-month safety and efficacy evaluation of NCX 470 vs. latanoprost.
NCX 470 Denali Phase 3 clinical trial: The second Phase 3 glaucoma clinical trial, jointly managed and equally funded by Nicox and Ocumension, is currently expected to start in Q4 2020. It will include clinical sites in both the U.S. and China, with the majority of the patients being in the U.S. The Denali trial was designed and is expected to be sufficient to support NDA filings in the U.S. and China.
NCX 4251 Phase 2b clinical trial: This Phase 2b trial will include both blepharitis and dry eye endpoints with the option of declaring either the blepharitis or dry eye endpoints as the primary outcome of the trial. Timing and further trial design details will be announced in due course.
ZERVIATETM China: A Phase 3 clinical trial for approval in China, to be conducted and financed by Ocumension, is currently expected to start by Q4 2
We continue to closely watch the spread of COVID-19 and its impact. We do not currently anticipate delays to our clinical timelines but we are monitoring the situation and will provide updates if there is an impact on our development projects and timelines.

Second Quarter 2020 and Recent Operational Highlights
The total number of prescriptions1 for VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, in the U.S. in the second quarter of 2020 increased by 36% compared to the second quarter of 2019 and was unchanged compared to the first quarter of 2020.
ZERVIATETM (cetirizine ophthalmic solution), 0.24%, U.S. prescriptions2 totaled 1,389 in Q2 2020, the first full quarter of sales following launch in the U.S. in March 2020.
We divested our shareholding in VISUfarma, a pan-European ophthalmic specialty pharmaceutical company, to a subsidiary of the main shareholder, GHO Capital, for €5 million.
The first Phase 3 clinical trial, named Mont Blanc, evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was initiated on June 1, 2020, and currently has over 40 clinical sites initiated in the trial. NCX 470 is the company’s novel, second-generation nitric oxide (NO)-donating bimatoprost analog. The Mont Blanc trial is a multi-regional, double-masked, 3-month, parallel group, adaptive design trial evaluating the efficacy and safety of NCX 470 ophthalmic solution, 0.065% and 0.1% compared to latanoprost ophthalmic solution, 0.005% in patients with open-angle glaucoma or ocular hypertension. In an adaptive portion of the trial, one NCX 470 dose will be selected to continue in the subsequent head-to-head 3-month efficacy and safety evaluation of NCX 470 vs. latanoprost. The primary efficacy evaluation is based on time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3. The trial is expected to randomize approximately 670 patients, primarily at approximately 50 clinical sites in the U.S. and at a small number of clinical sites in China.
A successful Type C meeting with the U.S. FDA was held, with agreement on Phase 2b trial designs for NCX 4251 in both acute exacerbations of blepharitis and the reduction of signs and symptoms of dry eye disease. NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, is Nicox’s second product candidate in clinical development. The timing of the future program for NCX 4251 is subject to securing the financial resources to advance its development.
Following results from in vivo primary pharmacodynamics studies of naproxcinod in models of sickle-cell disease, U.S. partner Fera Pharmaceuticals decided to focus its development of naproxcinod on the treatment of painful vaso-occlusive crisis in sickle-cell disease. Fera plans to conduct further studies and other development activities in preparation for entering directly into a clinical efficacy trial of naproxcinod in sickle-cell patients, subject to being granted an ODD.
Second Quarter 2020 Financial Highlights
As of June 30, 2020, the Nicox Group had cash and cash equivalents of €40.4 million as compared with €28.0 million at December 31, 2019 and €45.2 million at March 31, 2020. This figure does not include the €5 million from the divestment of our VISUfarma shareholding in July. Net revenue3 for the second quarter of 2020 was €0.6 million (consisting entirely of royalties), compared to €5.2 million (including €4,7 million of milestone and upfront payments) for the second quarter of 2019.

As of June 30, 2020, the Nicox Group had financial debt of €17.7 million in the form of a bond financing agreement with Kreos Capital signed in January 2019.

Only the figure related to the cash position of the Nicox Group as of December 31, 2019 is audited; all other figures of this press release are non-audited.

Notes
1. Bloomberg data, comparing the period of the weeks ending April 3, 2020 to June 26, 2020 with the period of the weeks ending January 3, 2020 to March 27, 2020 and April 5 2019 to June 28, 2019
2. Bloomberg data for the period of the weeks ending April 3, 2020 to June 26, 2020
3. Net revenue consists of revenue from collaborations less royalty payments, which corresponds to Net profit in the consolidated statements of profit or loss

On July 16, 2020 GlyTherix Ltd (GlyTherix) reported that a consortium led by the company are the successful recipients of a competitive grant in Round 9 of the Federal Government’s Cooperative Research Centres Projects (CRC-P) program (Press release, Glytherix, JUL 16, 2020, View Source [SID1234565141]).

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The grant will use the company’s proprietary novel target, Glypican-1, and its lead antibody to this target, Miltuximab, as a flagship molecule to develop national capability in manufacturing and distribution of radioimmuno-oncology drugs.

Radioimmunotherapy (RIT) uses antibodies to selectively deliver radiation to kill cancer cells, while limiting damage to healthy cells.

Dr Brad Walsh, CEO of GlyTherix, said that widespread adoption of RIT has been traditionally limited by the complex manufacturing process and short shelf life of the radioisotope.

"The grant brings together Australian SMEs, universities and government research organisations to pioneer manufacturing of "shake-and-bake" kits that allow on-site, on-demand production of RITs in hospital radio-pharmacies. Our Miltuximab antibody will be used as a testbed for the entire production process, testing safety and efficacy in a Phase 1 clinical trial. This project not only builds out our data around the technology but will also lead the way for Australia to develop sovereign capability in antibody manufacturing and RIT kits. Ultimately, these kits will help facilitate expanding a theranostic approach to cancer treatment in many more hospitals and patients," said Dr Walsh.

In this project radiolabelled Miltuximab is being used for both imaging and immunotherapy, known as ‘theranostics’. The project partners include Australian Nuclear Science And Technology Organisation (ANSTO), Commonwealth Scientific And Industrial Research Organisation (CSIRO), Cytiva (formerly GE Healthcare Life Sciences), Auspep Pty Ltd, University Of Technology Sydney and Macquarie University.

Dr Walsh said that the combined experience and expertise of the project partners augurs well for a successful project.

"We are grateful to the Federal Government for recognising the internationally competitive potential in this application. It’s extremely exciting to be commencing our manufacturing and clinical trial program for Miltuximab with such an esteemed group of experts in their field from highly respected Australian and International companies and institutions," said Dr Walsh.

"Theranostics is one of the most exciting areas of medicine and an area where Australia is a world leader. This CRC-P enables the diverse skills required to be assembled locally to benefit from our world leading position in this field of medicine. The pairing of a precision diagnostic with a corresponding precision therapeutic that targets Glypican-1 has the potential to treat a wide range of cancers. We are excited to be part of the program and looking forward to working on the antibody manufacturing process at UTS." Stephen O’Sullivan, Business Development Manager – ANZ, Cytiva (formally GE Lifescience).

Professor Roger Chung from Macquarie University Faculty of Medicine, Health and Human Sciences said the University was excited to be collaborating with GlyTherix and other consortia partners on this exciting translational research project. "Through MQ Health, the University’s integrated academic health centre, we provide an important pathway for academic and industry-led technology to be evaluated in a healthcare setting towards clinical translation."

Chris Chandler MD Auspep commented that "GlyTherix has done a great job in putting this CRC-P together. They have brought the right mix of knowledge from the industrial, government and academic sectors which will give the program it’s best chance of a successful, commercial outcome."

Dr Andrew Groth, UTS Faculty of Science Business Development Manager stated the partnership was a globally significant development and the production of antibodies in the UTS Biologics Innovation Facility demonstrates the power of university and industry collaboration. "UTS is extremely proud to be part of what is a landmark for the Australian biopharmaceutical industry with an end-to-end project from development to clinical trials," he said.

"Radioimmuno-oncology is one of the most exciting and dynamic areas in nuclear medicine and radiochemistry, with robust research and commercial interest globally. This timely CRC-P will establish an end-to-end national capability for antibody-based theranostics in Australia, building our reputation as a global leader in nuclear medicine clinical trials. ANSTO is proud to be a participant in this project delivering to our core missions of improving the health of all Australians and supporting Australian business." Dr Nigel Lengkeek, Senior Radiochemist, ANSTO.

GlyTherix is looking for investors who would like to be involved in the company’s Series A funding round.

On July 16, 2020 Cytokinetics, Incorporated (Nasdaq:CYTK) reported the pricing of an underwritten public offering of 7,291,667 shares of its common stock at a price to the public of $24.00 per share, before underwriting discounts and commissions (Press release, Cytokinetics, JUL 16, 2020, View Source,before%20underwriting%20discounts%20and%20commissions. [SID1234562042]). The gross proceeds to Cytokinetics from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Cytokinetics, are expected to be approximately $175.0 million. The offering is expected to close on July 21, 2020, subject to customary closing conditions. Additionally, Cytokinetics has granted the underwriters a 30-day option to purchase up to an additional 1,093,750 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock in the offering will be sold by Cytokinetics.

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Goldman Sachs & Co. LLC, Piper Sandler & Co. and Cantor Fitzgerald & Co. are acting as joint book-running managers for the offering. Barclays Capital Inc. is acting as an additional book-running manager for the offering. JMP Securities LLC is acting as lead co-manager, and Raymond James & Associates, Inc. and H.C. Wainwright & Co., LLC are acting as co-managers.

The securities described above are being offered by Cytokinetics pursuant to a shelf registration statement (including a prospectus) filed on November 6, 2019 with the Securities and Exchange Commission (SEC), which has become automatically effective. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed, and a final prospectus supplement and accompanying prospectus relating to the offering will be filed, with the SEC and can be accessed for free on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by phone at (866) 471‐2526 or by email at [email protected]; Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, New York 10022, or by email: [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone: 1-888-603-5847.

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 these 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 July 16, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that details of its plans to report second quarter 2020 financial results on August 3, 2020 (Press release, Ligand, JUL 16, 2020, View Source [SID1234562041]). Ligand’s CEO John Higgins, President and COO Matt Foehr, and Executive Vice President and CFO Matt Korenberg will host the conference call.

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Second Quarter 2020 Earnings Conference Call

What:

Ligand conference call to discuss financial results and provide general business updates

Date:

Monday, August 3, 2020

Time:

8:30 a.m. Eastern time (5:30 a.m. Pacific time)

Conference Call:

Dial (833) 325-0071 within the U.S.

Dial (720) 405-1612 outside the U.S.

Conference ID is 1697855

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

On July 16, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) repored that its second quarter 2020 financial results will be released on Thursday, July 30, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s second quarter 2020 financial results and will provide a business update (Press release, Gilead Sciences, JUL 16, 2020, View Source [SID1234562040]).

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The live webcast of the call can be accessed at the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 9561515 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, August 1, 2020. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 9561515. The webcast will be archived on www.gilead.com for one year.