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

TG Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, TG Therapeutics, 2017, NOV 9, 2017, View Source [SID1234521838]).

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Cellectar Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Cellectar Biosciences, 2017, NOV 9, 2017, View Source [SID1234521884]).

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On November 9, 2017 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported financial results for the three- and nine-months ended September 30, 2017 (Press release, Altimmune, NOV 9, 2017, View Source [SID1234521852]).

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Recent Corporate Highlights

Initiated a proof-of-concept Phase 2 Flu vaccine clinical trial with the Company’s first-in-class NasoVAX vaccine, with initial data expected in 1Q-2018.
Completed enrollment in the Company’s HepTcell immunotherapeutic Phase 1 clinical trial against hepatitis B, with topline data expected in 4Q-2017.
Remained on track to initiate a BARDA-funded Phase 1 trial with NasoShield, a next-generation intranasal, single-dose, anthrax vaccine in the first quarter of 2018, with topline data anticipated in the second quarter of 2018.
Remained on track to initiate a key pre-clinical bridging study with SparVax-L, a lyophilized anthrax vaccine, in the fourth quarter. The study is fully-funded by NIAID.
Closed a Series B preferred stock offering, raising approximately $13.0 million in net proceeds
"We are pleased with the progress we have made this quarter in developing our product candidates. We are actively moving forward each of our four clinical stage assets with data readouts from all four of these programs expected within the next 8 months. We initiated a Phase 2 clinical trial with our NasoVAX flu vaccine therapy as planned this past quarter," said Bill Enright, Chief Executive Officer of Altimmune. "Additionally, we have completed enrollment in our HepTcell Phase 1 clinical trial in hepatitis B and expect to see data before the end of the year. We also remain on track in our two government-funded anthrax vaccine programs. We are excited for our upcoming milestones and thank our employees for the tremendous work and effort put forth to continue moving our programs forward."

Financial Results for the three- and nine-months ended September 30, 2017

Revenue and grants and contracts for the three- and nine-months ended September 30, 2017 were $4.6 million and $7.9 million, respectively, compared to $0.9 million and $2.2 million for the comparable periods in 2016. For the three-months ended September 30, 2017, there was a $3.0 million increase in revenue from the BARDA contract compared to the same period in 2016. Revenue and grants and contracts for the three-months ended September 30, 2017 also included $0.6 million from a contract with NIAID that was entered into by PharmAthene prior to the merger.

Research and development expenses were $5.9 million and $13.9 million for the three- and nine-months ended September 30, 2017, respectively, as compared to $2.4 million and $4.8 million for same periods in 2016. For the three-months ended September 30, 2017, there was an increase in spending on the development of the NasoShield product candidate; an increase in manufacturing and other costs in preparation for the NasoVAX Phase 2 trial; and an increase related to the addition of research and development costs of the SparVax-L asset, all of which were partially offset by a decrease in other research and development costs, compared to the same period in 2016.

General and administrative expenses were $3.0 million and $6.9 million, for the three- and nine-months ended September 30, 2017, respectively, as compared with $3.3 million and $5.3 million, in the same periods in 2016. For the three-months ended September 30, 2017, there was an increase in legal and professional costs related to the Mergers; an increase in other general and administrative expenses; an increase in general and administrative expenses related to the Mergers; and an increase in stock compensation, all of which were offset by a $2.3 million write down of deferred offering costs in September 2016, resulting in a decrease compared to the same period in 2016.

As of September 30, 2017, we determined that our goodwill was impaired and a non-cash goodwill impairment charge of $26.6 million was recorded during the quarter, and was classified as a component of operating expenses. The non-cash charge resulted from our goodwill assessment based on our market capitalization plus an implied control premium relative to the carrying value of our net assets. The non-cash charge has no effect on our current cash balance or operating cash flows.

Net loss attributed to common stockholders for the three- and nine-months ended September 30, 2017 was $31.9 million and $39.7 million, respectively. The increase in net loss is primarily due to a non-cash goodwill impairment charge of $26.6 million. Excluding the non-cash goodwill impairment charge, net loss attributed to common stockholders for the three- and nine-months ended September 30, 2017 was $5.3 million and $13.1 million, respectively, compared with $4.9 million and $8.3 million in the same periods in 2016.

Net loss per share attributed to common stockholders for the three- and nine-months ended September 30, 2017, was $2.05 and $3.43, respectively. Excluding the preliminary non-cash goodwill impairment charge, net loss per share attributed to common stockholders for the three- and nine-months ended September 30, 2017 was $0.34 and $1.13, respectively, compared with $0.71 and $1.20 in the same periods of 2016.

At September 30, 2017, the Company had cash and cash equivalents of approximately $17.1 million.

Non-GAAP Measures

To supplement the Company’s unaudited financial statements presented in accordance with generally accepted accounting principles ("GAAP"), this press release includes a discussion of adjusted net loss attributed to common stockholders and adjusted net loss per share attributed to common stockholders, in each case adjusted for the loss due to a goodwill impairment charge. The Company believes that these non-GAAP measures, when taken into consideration with the corresponding GAAP financial measures, provide investors with meaningful comparisons of current results to prior period results by excluding items that the Company does not believe reflect its fundamental business performance. See the attached schedule for a reconciliation of net loss to adjusted net loss and loss per share to adjusted loss per share for the three and nine months ended September 30, 2017 and 2016.

Conference Call Details

Date: Friday, November 10
Time: 8:30am Eastern Time
Domestic: 877-718-5098
International: 719-325-4831
Conference ID: 5172794
Webcast: View Source

Replays will be available through November 24:
Domestic: 844-512-2921
International: 412-317-6671
Replay PIN: 5172794