On March 6, 2019 LIDDS AB reported that the last patient has been enrolled in LIDDS Phase IIb study for the localized treatment of prostate cancer (Press release, Lidds, MAR 6, 2019, View Source [SID1234555910]). The Phase IIb study will identify the optimal dose for Phase III and test the safety of Liproca Depot and its effectiveness in stopping cancer progression. Liproca Depot is based on LIDDS unique NanoZolid drug delivery technology.

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-We are very pleased that patient recruitment is now finalized and we look forward to concluding the study and receiving the results in third quarter this year, says Monica Wallter, CEO.

-We expect this study to show that by injecting Liproca Depot directly into the tumor, prostate cancer progression can be stopped and patients can avoid radical surgery and radiation therapy which are associated with side effects such as sexual dysfunction and incontinence, says Monica Wallter.

-A large prostate cancer patient group is currently not receiving any treatment and Liproca Depot has the potential to provide a new treatment regimen that will benefit healthcare providers and prostate cancer sufferers in a market worth over USD 9 billion annually, says Monica Wallter.

The Phase IIb study for Liproca Depot includes 60 patients and is being conducted at major urology clinics in Canada, Finland and Lithuania.

LIDDS has already signed an exclusive licensing agreement for Liproca Depot in China with the Puheng Jiangxi pharmaceutical company. Preparations are ongoing in China for a Phase III clinical study that will be fully funded by the Chinese licensee. Prostate cancer is a very common disease in China and around 500 000 patients are diagnosed each year.

-We look forward to continuing our dialogue with major pharmaceutical companies on out-licensing Liproca Depot in the US, Europe and the rest of the world. With more than USD 3 billion currently being spent each year on localized prostate cancer treatment, Liproca Depot can offer a new regimen that benefits patients, healthcare providers and pharmaceutical companies, says Monica Wallter.

About the study:
The study (LPC-004) consists of two parts. The first part of the study is evaluating the tolerability and safety of substantially higher doses of the anti-androgen 2-HOF (2-hydroxyflutamide) compared to earlier Phase II studies with Liproca Depot. In the second part, consisting of 40 patients, LIDDS will receive efficacy results measured with the biomarker PSA, prostate volume, MRI data and Quality of Life reports.

In the study, patients diagnosed with a localized non-aggressive prostate cancer received intra-prostatic injections of Liproca Depot containing NanoZolid and the anti-androgen drug 2-HOF. All participating subjects were defined as "Active Surveillance" patients, not chosen for surgery or radiation therapy. Patients are being followed for six months to assess the anti-androgen response and cancer control.

On March 6, 2019 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, reported the pricing of its previously announced underwritten public offering of 8,000,000 shares of its common stock at a public offering price of $12.50 per share, before underwriting discounts and commissions (Press release, CymaBay Therapeutics, MAR 6, 2019, View Source [SID1234534028]). All of the shares of common stock are being offered by CymaBay. In addition, CymaBay has granted the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of common stock at the public offering price less underwriting discounts and commissions. CymaBay anticipates using the net proceeds from the offering to fund ongoing development of seladelpar and for working capital and general corporate purposes.

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The offering is expected to close on March 8, 2019, subject to the satisfaction of customary closing conditions.

Citigroup, Evercore ISI and Cantor Fitzgerald & Co. are acting as the joint book-running managers for the offering. Oppenheimer & Co. Inc. and Roth Capital Partners are acting as co-managers for the offering.

The securities described above are being offered by CymaBay pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and the accompanying prospectus related to the offering have been filed with the SEC and are available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available may be obtained from: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or telephone: 1-800-831-9146; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email 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 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 March 6, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present at two upcoming investor conferences (Press release, Kura Oncology, MAR 6, 2019, View Source [SID1234534048]):

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Cowen and Company Health Care Conference in Boston on March 12, 2019 at 9:20 a.m. ET / 6:20 a.m. PT; and

Oppenheimer Healthcare Conference in New York on March 19, 2019 at 2:10 p.m. ET / 11:10 a.m. PT.
A live audio webcast and replay of each presentation will be available in the Investors section of Kura Oncology’s website at www.kuraoncology.com.

On March 6, 2019 Exact Sciences Corporation (NASDAQ: EXAS) reported that it has priced its underwritten public offering of 0.3750% convertible senior notes due 2027 (the "Notes") and upsized the offering from $600 million to $650 million aggregate principal amount (Press release, Exact Sciences, MAR 6, 2019, View Source [SID1234534175]). The Company has granted the underwriter a 30-day option to purchase up to an additional $97.5 million aggregate principal amount of the Notes solely to cover over-allotments, if any.

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The Notes will be senior unsecured obligations of the Company and will bear interest at a rate of 0.3750% per annum. Interest on the Notes will be payable semi-annually in arrears on March 15 and September 15 of each year, beginning September 15, 2019. The Notes will be convertible into cash, shares of the Company’s common stock (and, if applicable, cash in lieu of any fractional share), or a combination thereof, at the Company’s election. The initial conversion rate will be 8.9554 shares of the Company’s common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $111.6645 per share. The Notes will mature on March 15, 2027, unless earlier converted or repurchased in accordance with their terms prior to such date, and may not be redeemed by the Company prior to maturity. Prior to September 15, 2026, the Notes will be convertible only upon the occurrence of certain events and during certain periods, and thereafter, until the close of business on the second scheduled trading day immediately preceding the maturity date.

The offering is expected to close on March 8, 2019, subject to customary closing conditions. Concurrently with this offering, in separate transactions, the Company expects to enter into agreements with certain holders of its 1.0% Convertible Senior Notes due 2025 (the "2025 Notes") to exchange an aggregate of approximately $493.4 million of the outstanding principal amount of the 2025 Notes for consideration consisting of (1) an aggregate amount of approximately $493.3 million in cash and (2) an aggregate amount of approximately 2.16 million shares of the Company’s common stock. The terms of such agreements have been or will be individually negotiated and will depend on the market price of the Company’s common stock and the trading price of the 2025 Notes at the time such agreements are entered into. The cash portion of such consideration will be funded from net proceeds from this offering. The Company may also exchange or induce conversions of the 2025 Notes following completion of this offering and may fund such exchanges or conversions with the proceeds of this offering. The Company intends to use the remaining net proceeds of this offering for general corporate and working capital purposes.

BofA Merrill Lynch is acting as the sole book-running manager for the Notes offering.

An automatically effective shelf registration statement relating to the Notes was filed with the SEC on June 6, 2017. A copy of the prospectus supplement and prospectus relating to the Notes offering may be obtained free of charge on the SEC’s website at View Source or by sending a request to BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department (or by e-mail at [email protected]).

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state. The offering of the Notes will be made only by means of the prospectus and related prospectus supplement.

On March 6, 2019 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, 2018, as approved by the Board of Directors on March 5, 2019, and provided upcoming 2019 milestones (Press release, NicOx, MAR 6, 2019, View Source [SID1234533991]).

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2018 Financial Summary
In 2018, the Loss before tax of the Nicox Group was €18.3 million compared to €19.1 million in 2017. This reduction was achieved despite the significant investments in research and development made in 2018.

Net revenue for the 12 months to December 2018 was €4.0 million, which consists of the upfront payment from Ocumension Therapeutics for the license of NCX 470 for the Chinese market and net royalties on sales of VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% by global partner Bausch + Lomb. This compares to a Net revenue for the 12 months to December 2017 of €2.3 million.

Operating expenses for the period 2018 increased to €26.5 million from €20.8 million for the 12 months to December 31, 2017 mainly due to investments in the development of our wholly-owned programs, NCX 470 and NCX 4251.

As of December 31, 2018, the Nicox Group had cash and cash equivalents of €22.0 million as compared with €41.4 million at December 31, 2017.

Event after the Reporting Period
On January 25, 2019, Nicox entered into a bond financing for up to €20 million from Kreos Capital, which together with cash on hand and anticipated royalties potentially extends the Company’s cash runway into 2021. 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.

Upcoming 2019 Milestones
NCX 470: Top-line results from the Phase 2 clinical study for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension expected in Q4 2019.
NCX 4251: Phase 2 clinical study in patients with acute exacerbations of blepharitis to start shortly, with top-line results expected in Q4 2019.
ZERVIATETM U.S. launch: Commercial launch of ZERVIATE (cetirizine ophthalmic solution), 0.24% in the U.S. by our U.S. partner Eyevance Pharmaceuticals expected in summer 2019.
ZERVIATE ex-US partnering: Potential new licensing agreements, with multiple discussions ongoing.
Presentations on Nicox’s ophthalmology programs at key scientific conferences including the American Glaucoma Society (AGS), the Association for Research in Vision and Ophthalmology (ARVO).