On November 9, 2017 IntelGenx Technologies Corp. (TSX VENTURE:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the third quarter ended September 30, 2017 (Press release, IntelGenx, NOV 9, 2017, View Source [SID1234521874]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2017 Third Quarter Financial Highlights:

Revenue was $1.3 million, compared to $1.8 million in the same period last year
Adjusted EBITDA was ($340,000), compared to adjusted EBITDA of $311,000 in the same period last year
Raised gross proceeds of CDN$7.6 million (US$6.1 million) via a prospectus offering of convertible unsecured subordinated debentures
Cash and short-term investments totalled $6.9 million as at September 30, 2017
Recent Developments:

Announced that the Company, together with Redhill Biopharma Ltd., resubmitted the 505(b)(2) New Drug Application to the U.S. Food and Drug Administration for RIZAPORT 10 mg
Announced that the U.S. District Court for the District of Delaware determined that the process used to manufacture IntelGenx’ and Par Pharmaceutical Inc.’s buprenorphine/naloxone sublingual film product for the treatment of opiate addiction does not infringe MonoSol Rx U.S. Patent No. 8,900,497
Announced that in a separate decision requesting the judge to reconsider its June 28, 2016 decision finding that IntelGenx’ and Par’s product would infringe the asserted claims of U.S. Patent No. 8,603,514, the U.S. District Court for the District of Delaware denied IntelGenx’ and Par’s motion to reopen the case on procedural grounds. The decision on the motion to reopen the case allows IntelGenx’ and Par’s previously filed appeal to proceed forward
"With the completion of convertible debenture offering during the third quarter, we secured the necessary financial resources to continue executing our growth strategy," commented Dr. Horst G. Zerbe, President and CEO of IntelGenx. "Subsequent to quarter-end, we took importantsteps towards bringing our proprietary thin-film product for the treatment of acute migraines to the U.S. market through the resubmission of the RIZAPORT 505(b)(2) NDA. The advancement of our product pipeline toward commercialization will continue to be a key priority throughout the remainder of 2017 and in 2018."

Financial Results:

Total revenues for the three-month period ended September 30, 2017 amounted to $1.3 million, compared to $1.8 million for the three-month period ended September 30, 2016. The decrease for the three-month period ended September 30, 2017 compared to the last year’s corresponding period is mainly attributable to a decrease in licenses and other revenues.

Operating costs and expenses were $1.8 million for the third quarter ended September 30, 2017, versus $1.7 million for the corresponding quarter in 2016. The increase for the three-month period ended September 30, 2017 is mainly attributable to an increase in Research and Development expenses of $190,000, offset partially by a $109,000 decrease in Selling, General and Administrative expenses.

For the third quarter ended September 30, 2017, the Company had an operating loss of $569,000, compared to operating income of $88,000 for the comparable period of 2016.

Net comprehensive loss was $586,000 or $0.01 on a basic and diluted per share basis, for the period ended September 30, 2017, compared to net comprehensive income of $62,000, or $0.00 on a basic and diluted per share basis, for the comparable period of 2016.

As of September 30, 2017, the Company’s cash and short-term investments totalled $6.9 million.

Conference Call Details:

IntelGenx will host a conference call to discuss its third quarter 2017 financial results today, November 9, 2017, at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269. The call will be webcast live and archived for twelve months at www.intelgenx.com.

On November 9, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported updated data from the Company’s Phase 1b/2 study of TRC105 and Votrient (pazopanib) in patients with angiosarcoma at the Connective Tissue Oncology Society (CTOS) annual meeting taking place in Maui, Hawaii (Press release, Tracon Pharmaceuticals, NOV 9, 2017, View Source;p=RssLanding&cat=news&id=2315809 [SID1234521907]).

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In poster presentation 2804349 entitled, "Every Other Week Dosing of TRC105 (Endoglin Antibody) in Combination with Pazopanib in Patients with Advanced Soft Tissue Sarcoma," updated data were presented from 18 angiosarcoma patients treated with the combination of TRC105 and Votrient, and an additional cohort of six soft tissue sarcoma patients treated with a hybrid dosing schedule of TRC105 and Votrient. Key results included:

TRC105 target concentrations previously shown to saturate endoglin receptors were achieved continuously using a TRC105 hybrid dosing schedule of 10 mg/kg weekly for four weeks followed by 15 mg/kg every other week.
Median progression-free survival (PFS) was 7.8 months in 13 VEGF inhibitor naïve angiosarcoma patients treated with the combination of TRC105 and Votrient using either 10 mg/kg weekly dosing or the hybrid dosing schedule of TRC105. This compares favorably to the median PFS of 3 months reported in a retrospective study of single agent Votrient in patients with angiosarcoma.
In the 17 patients who received prior treatment of metastatic disease, treatment duration on TRC105 and Votrient exceeded the duration of the most recent prior therapy in 7 of 12 VEGF naïve angiosarcoma patients and 2 of 5 patients who received a prior VEGF inhibitor as part of their most recent prior therapy.
Treatment with the combination of TRC105 and Votrient continued to be well-tolerated and allowed for dosing of the combination for more than two years in patients who experienced complete responses to treatment.

"The combination of TRC105 and Votrient continues to demonstrate the potential to deliver meaningful benefits to angiosarcoma patients. We continue to achieve important progress with the clinical development of this compelling product candidate, as our pivotal Phase 3 TAPPAS trial is now open at more than 20 sites in the U.S., and European sites are expected to open by year-end," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We also continue to evaluate every other week dosing of TRC105 in other indications, including lung and liver cancers."

The poster is available on TRACON’s website at www.traconpharma.com.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

On November 9, 2017 Shire plc (LSE: SHP, NASDAQ: SHPG), the leading biotechnology company focused on serving people with rare diseases, reported the broad range of research it will present at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 9-12, 2017, in Atlanta, Georgia (Press release, Shire, NOV 9, 2017, View Source [SID1234521927]). Shire’s presence at ASH (Free ASH Whitepaper) spans its hematology and oncology franchises with 2 oral presentations and 7 poster presentations.

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"Shire’s commitment to fighting rare disease, particularly in hematology and oncology, is reflected in the company’s strong presence at ASH (Free ASH Whitepaper), one of the world’s premier medical conferences focused on blood disorders," said Howard B. Mayer, M.D., SVP and ad-interim Head, Global Research and Development, Shire. "We are committed to continuous and ambitious innovation that helps advance the standards of care and improves outcomes in these therapeutic categories where there remains significant unmet patient need."

HEMATOLOGY
The research presented at ASH (Free ASH Whitepaper) will showcase Shire’s broad hematology portfolio, which covers a wide range of rare bleeding indications and highlights real-world safety and efficacy data. In addition to presenting new research, Shire will share updates related to its ongoing innovation and promising pipeline of investigational treatments. Shire has provided a grant to support a satellite symposium at ASH (Free ASH Whitepaper) hosted by CMEology that is focused on the latest strategies and innovations to help advance best practices in the management of hemophilia:

Advancing Standards in the Management of Hemophilia A: Contemporary Strategies and Innovations. Friday, December 8, 2017, 6:00-10:00 p.m. EST. Hyatt Regency Atlanta, International Ballroom North. For more details or to register, visit: View Source
ONCOLOGY
Shire’s expertise in rare and difficult-to-treat cancers includes ongoing research into investigational pegylated asparaginase, as a component of antineoplastic combination therapy in acute lymphoblastic leukemia (ALL). The company’s pipeline in oncology includes assets being developed for the treatment of metastatic pancreatic cancer, ALL, lung cancer, as well as early stage checkpoint inhibitor and allogeneic CAR T targets. At ASH (Free ASH Whitepaper) 2017, Shire is co-supporting an Independent Medical Education program organized by prIME-Oncology on:

Optimizing Management of Acute Lymphoblastic Leukemia: From Adolescence to Adults. Friday, December 8, 2017, 12:30-4:30 p.m. EST. Hyatt Regency Atlanta, International Ballroom North. For more details or to register, visit: View Source
For further information please contact:
Investor Relations
Ian Karp [email protected] +1 781 482 9018
Robert Coates [email protected] +44 203 549 0874
Media
Gwen Fisher [email protected] +1 781 482 9649
Molly Poarch [email protected] +1 312 965 3413

Lixte Biotechnology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Lixte Biotechnology, 2017, NOV 9, 2017, View Source [SID1234521830]).

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Fortress Biotech has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Fortress Biotech, 2017, NOV 9, 2017, View Source [SID1234521848]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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