On November 13, 2019 Oncoceutics, Inc. reported that results from the second and third cohort of the Phase II trial for patients with recurrent glioblastoma treated with the company’s lead imipridone, ONC201, were recently published in the journal Neuro-Oncology (Press release, Oncoceutics, NOV 13, 2019, View Source [SID1234558331]). This manuscript represents the third publication among a series of reports demonstrating durable radiographic regressions with ONC201 in patients with H3 K27M-mutant glioma. The study (NCT02525692) also demonstrated that weekly oral administration of ONC201 given as a single agent was well-tolerated, achieved therapeutic intratumoral concentrations, and intratumoral pharmacodynamic activity in adult recurrent glioblastoma patients.

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ONC201 achieved intratumoral concentrations that exceeded preclinical efficacy thresholds and induced intratumoral biomarkers of pharmacodynamic signaling and apoptosis indicating target engagement. The radiographic regression of multi-focal, multi-recurrent disease with ONC201 administration in an adult recurrent H3 K27M-mutant glioblastoma patient remained durable for >1.5 years. No treatment modifications or discontinuations due to toxicity were observed, including those who underwent re-resection.

A previous publication on the first cohort of the study had demonstrated that ONC201 is well-tolerated in adult recurrent glioblastoma patients with every three-week dosing and achieved an objective radiographic response in a patient harboring the H3 K27M mutation that remained durable for >2.5 years. Other publications have reported radiographic regressions and clinical benefit in pediatric and adult H3 K27M-mutant diffuse midline glioma patients including those with diffuse intrinsic pontine glioma (DIPG).

High-grade glioma with the H3 K27M mutation is the lead indication for ONC201 and FDA has awarded Fast-Track designation to ONC201 for the treatment of adults with this disease who have recurred. The publication is supported by Small Business Innovation Research (SBIR) Fast-track and Bridge grants from the National Cancer Institute of the National Institutes of Health, as well as The Musella Foundation.

"These results indicate weekly ONC201 is very well tolerated and biologically active in a molecular subset of glioblastoma patients associated with biomarkers of dopamine receptor dysregulation," said Isabel Arrillaga-Romany, MD, PhD, Director of Neuro-Oncology Clinical Trials at Massachusetts General Hospital and the Principal Investigator and corresponding author of the study. "The durable regression observed in a 74-year old patient with sub-centimeter multi-focal, multi-recurrent H3 K27M-mutant glioma is particularly noteworthy given the development focus of ONC201 in this subset of brain tumors."

"Overall, the safety and efficacy results with ONC201 in recurrent glioblastoma are promising and unlike any other targeted agent we have evaluated thus far," said Patrick Y. Wen, MD, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and senior author and investigator of the study. "ONC201 continues to be promising as a single agent in molecular subsets of high-grade glioma and the intratumoral pharmacodynamic results suggest the activity of ONC201 may extend beyond H3 K27M-mutant gliomas to high-grade glioma subsets that also exhibit dopamine pathway dysregulation."

On November 13, 2019, Exicure, Inc. (the "Company") reported that it has entered into a Collaboration, Option and License Agreement (the "Collaboration Agreement") with a wholly-owned subsidiary of Allergan plc, Allergan Pharmaceuticals International Limited ("Allergan") (Filing, 8-K, Exicure, NOV 13, 2019, View Source [SID1234553517]). Pursuant to the Collaboration Agreement, the Company granted to Allergan exclusive access and options to license spherical nucleic acid ("SNA") based therapeutics arising from two collaboration programs related to the treatment of hair loss disorders. Each such license would grant to Allergan exclusive, royalty-bearing, sublicenseable, nontransferable, worldwide rights to develop, manufacture, use and commercialize such SNA therapeutics. Upon written notice to the Company, Allergan may exercise its option at any time following the effective date of the Collaboration Agreement until the expiration of the corresponding collaboration program’s option exercise period (each, an "Option Exercise Period").

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Under the terms of the Collaboration Agreement, the Company will conduct discovery and development in two collaboration programs for hair loss disorders. The Company shall be solely responsible for all costs and expenses of conducting each collaboration program through the completion of initial preclinical activities, and, if Allergan pays the option extension payment described below, all additional activities that are necessary to enable the first filing of an investigational new drug application ("IND"), except to the extent Allergan elects to conduct any formulation assessment activities or in vivo efficacy models. In the event that Allergan exercises an option, Allergan will be responsible for further development from the license effective date and commercialization of the corresponding licensed product.

Under the terms of the Collaboration Agreement, the Company will receive an upfront payment of $25 million, and, if Allergan exercises any of its option rights, Allergan will pay to the Company an option exercise fee equal to $10 million for each exercised option, if such option is exercised during the initial option exercise period. Should Allergan wish to extend an option exercise period beyond the applicable initial exercise period for a particular program, Allergan must pay the Company a one-time option extension payment in the amount of $10 million for each such option exercise period extension and the option payment to exercise the option during such option period extension shall then be $15 million for each exercised option.

If Allergan exercises an option for a program, development and regulatory milestones will be payable for that program upon the initiation of certain clinical trials, and acceptance of the filing for processing by the FDA in the United States and by 2 additional regulators outside the United States of a marketing application for review, per program, with an aggregate total of up to $195 million if both options are exercised. Commercial milestones will be payable for that program upon first commercial sale of a licensed product in certain jurisdictions and the achievement of specified aggregate sales thresholds for all licensed products from that program, with an aggregate total of up to $530 million if both options are exercised. In the event a therapeutic candidate subject to the collaboration results in commercial sales, the Company is eligible to receive tiered royalties at percentages ranging from the mid-single digits to the mid-teens on future net product sales of such commercialized therapeutic candidates. A percentage of the aforementioned payments will be due to Northwestern University ("Northwestern") upon receipt, pursuant to the Company’s existing license agreements with Northwestern (the "Northwestern License Agreements").

The Collaboration Agreement will remain in effect, unless earlier terminated, until (a) the expiration of the later-to-expire option exercise period, if Allergan does not exercise either option, or (b) the expiration of the last-to-expire royalty term for any licensed product in such country on a licensed product-by-licensed product and country-by-country basis, if Allergan exercises one or both options. Upon expiration of the royalty term with respect to a particular licensed product in a country, the license for such product in such country will convert to a worldwide, fully-paid, irrevocable and perpetual license.

The Collaboration Agreement also contains customary provisions for termination by either party, including in the event of breach of the Collaboration Agreement, subject to cure, by Allergan for convenience and by the Company upon a challenge of the licensed patents, subject, in certain cases, to customary reversion rights. Upon termination of the Collaboration Agreement by Allergan for convenience or by either party for the other’s breach or bankruptcy, all licenses granted by the Company to Allergan will terminate.

The Collaboration Agreement includes customary representations and warranties on behalf of both the Company and Allergan. The Collaboration Agreement also provides for customary mutual indemnities.

On November 13, 2019 Reata Pharmaceuticals, Inc. (Nasdaq:RETA) ("Reata" or the "Company"), a clinical-stage biopharmaceutical company, reported the pricing of an underwritten public offering of 2,400,000 shares of its Class A common stock at a price to the public of $183.00 per share (Press release, Reata Pharmaceuticals, NOV 13, 2019, View Source [SID1234551306]). The offering was upsized to 2,400,000 shares from the original offering size of 2,000,000 shares. The gross proceeds to Reata from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $439,200,000. The offering is expected to close on November 18, 2019, subject to customary closing conditions. In addition, Reata has granted the underwriters a 30-day option to purchase up to an additional 360,000 shares of Reata’s Class A common stock on the same terms and conditions.

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Citigroup, Jefferies, SVB Leerink and Stifel are acting as the joint book-running managers for the offering. Baird, Cantor and Ladenburg Thalmann are acting as co-managers for the offering.

Reata intends to use the net proceeds from the offering for working capital and general corporate purposes, which include, but are not limited to, advancing the development of bardoxolone methyl and omaveloxolone through clinical trials, preparing to file New Drug Applications for bardoxolone for the treatment of patients with Alport syndrome and omaveloxolone for the treatment of patients with Friedreich’s ataxia, planning for commercialization of its potential products, and making payments due under its agreement with AbbVie Inc.

The securities described above are being offered pursuant to an effective shelf registration statement on Form S-3. The offering may be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the Securities and Exchange Commission (the "SEC") and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by request at Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 (Tel: 800-831-9146); at Jefferies, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected]; at SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected]; or Stifel, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at [email protected].

This news release is for informational purposes only and 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 of these securities would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 13, 2019 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in therapeutic ultrasound, reported financial results for the third quarter and nine months of 2019 and provided an update on strategic and operational developments (Press release, EDAP TMS, NOV 13, 2019, View Source [SID1234551305]).

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Marc Oczachowski, EDAP’s Chief Executive Officer, said, "During the third quarter, we were able to sustain the sales momentum that carried us through the first half of the year. We sold an additional two Focal One units, including one to the world renowned Mayo Clinic bringing our year-to-date total to nine. At the same time, our pipeline continues to grow, particularly in the U.S., where we are still in the early stages of our hospital and physician education and outreach efforts. As a recognized leader in therapeutic ultrasound, we believe we have established a solid foundation from which to drive future growth."

Third Quarter 2019 Results

Total revenue for the third quarter 2019 was EUR 10.3 million (USD 11.3 million), a 26.7% increase compared to EUR 8.1 million (USD 9.5 million) for the third quarter of 2018.

Total revenue in the HIFU business for the third quarter 2019 was EUR 2.8 million (USD 3.1 million), a 44.4% increase compared to EUR 1.9 million (USD 2.3 million) for the third quarter of 2018.

For the three months ended September 30, 2019, total revenue for the UDS division was EUR 7.5 million (USD 8.3 million), a 21.2% increase compared to EUR 6.2 million (USD 7.2 million) during the year-ago period.

Gross profit for the third quarter 2019 was EUR 4.7 million (USD 5.1 million), compared to EUR 3.4 million (USD 3.9 million) for the year-ago period. Gross profit margin on net sales was 45.3% in the third quarter of 2019, compared to 41.5% in the year-ago period.

Operating expenses were EUR 4.4 million (USD 4.9 million) for the third quarter of 2019, compared to EUR 4.1 million (USD 4.7 million) for the same period in 2018.

Operating profit for the third quarter 2019 was EUR 0.3 million (USD 0.3 million), compared to an operating loss of EUR 0.7 million (USD 0.8 million) in the third quarter of 2018.

Net income for the third quarter 2019 was EUR 0.8 million (USD 0.9 million), or earnings of EUR 0.03 per diluted share, as compared to a net loss of EUR 0.7 million (USD 0.8 million), or a loss of EUR 0.02 per diluted share in the year-ago period.

First nine months 2019 Results

Total revenue for the first nine months of 2019 was EUR 32.9 million (USD 36.9 million), a 27.1% increase compared to EUR 25.9 million (USD 30.9 million) for the first nine months of 2018.

Total revenue in the HIFU business for the first nine months of 2019 was EUR 11.2 million (USD 12.6 million), a 67.8% increase compared to EUR 6.7 million (USD 8.0 million) for the nine months ended September 30, 2018.

For the nine months ended September 30, 2019, total revenue for the UDS division was EUR 21.7 million (USD 24.3 million), a 13.0% increase compared to EUR 19.2 million (USD 22.9 million) during the year-ago period.

Gross profit for the first nine months of 2019 was EUR 15.9 million (USD 17.8 million), compared to EUR 10.9 million (USD 13.0 million) for the year-ago period. Gross profit margin on net sales was 48.2% compared to 42.3% in the year-ago period.

Operating expenses were EUR 13.7 million (USD 15.4 million) for the first nine months of 2019, compared to EUR 13.1 million (USD 15.6 million) for the same period in 2018.

Operating profit for the first nine months of 2019 was EUR 2.1 million (USD 2.4 million), compared to an operating loss of EUR 2.2 million (USD 2.6 million) in the first nine months of 2018.

Net income for the first nine months of 2019 was EUR 2.5 million (USD 2.8 million), or earnings of EUR 0.08 per diluted share, as compared to a net loss of EUR 1.4 million (USD 1.6 million), or a loss of EUR 0.05 per diluted share in the year-ago period.

As of September 30, 2019, cash and cash equivalents were EUR 17.7 million (USD 19.3 million).

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30 am EDT on Wednesday November 14, 2019. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Thursday, November 14, 2019 @ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13695746
Webcast: View Source

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."

On November 13, 2019 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the following upcoming conferences (Press release, Horizon Therapeutics, NOV 13, 2019, View Source [SID1234551304]):

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Stifel 2019 Healthcare Conference

Date: Tuesday, Nov. 19, 2019
Presentation Time: 9:45 a.m. EST
Location: New York
Jefferies 2019 London Healthcare Conference

Date: Wednesday, Nov. 20, 2019
Presentation Time: 8:00 a.m. GMT
Location: London
Piper Jaffray 31st Annual Healthcare Conference

Date: Tuesday, Dec. 3, 2019
Presentation Time: 12:00 p.m. EST
Location: New York
The conference presentations will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcasts will be available for the events.