On December 21, 2019 Helix BioPharma Corp. (TSX, FSE: "HBP") ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has closed a third tranche of a private placement financing for gross proceeds of CAD700,800 (Press release, Helix BioPharma, DEC 21, 2018, View Source [SID1234533056]). Helix closed the first and second tranches of the private placement on December 6, 2018 and December 20, 2018 for gross proceeds of CAD871,200 and CAD342,000, respectively. The Company expects to complete a final tranche of the private placement financing before the end of December.

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The terms of the placement are for the purchase of units at $1.20 per unit. Each unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant will entitle the holder to purchase one common share at an exercise price of $1.50 and have an expiry of five years from the date of issuance. Helix intends to use the net proceeds of the private placement for working capital and research and development activities.

ACM Alpha Consulting Management AG provided financial advisory services to Helix in connection with the private placement.

On December 21, 2018 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 that its Phase 2 TRAXAR trial evaluating TRC105 in combination with Inlyta (axitinib) in patients with advanced or metastatic renal cell carcinoma did not meet the primary endpoint of improving progression free survival (PFS) in the intent to treat population compared to Inlyta monotherapy (Press release, Tracon Pharmaceuticals, DEC 21, 2018, View Source [SID1234532224]).

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Prespecified statistical analyses of PFS according to expression of two plasma biomarkers, TGFβ receptor III and osteopontin, also did not achieve statistical significance. The safety profile observed in TRAXAR was consistent with that observed in previously reported studies of TRC105 in combination with VEGF inhibitors.

TRACON will work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.

"We are disappointed that TRC105 in combination with Inlyta did not demonstrate clinically meaningful efficacy in patients with advanced or metastatic renal cell carcinoma. Importantly, data from TRAXAR, including analyses of an extensive biomarker panel, will contribute to our understanding of the role of endoglin inhibition in combination with VEGF inhibitors, and may inform our broad TRC105 clinical development program," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We remain focused on the interim analysis to determine the final sample size of the Phase 3 TAPPAS trial of TRC105 and Votrient in angiosarcoma, which is expected in the first quarter of 2019."

About the TRAXAR trial in Advanced or Metastatic Renal Cell Carcinoma

The TRAXAR trial compared treatment with TRC105 and Inlyta to treatment with single agent Inlyta in 150 patients with advanced or metastatic renal cell carcinoma with a clear cell component. Patients were randomized in equal numbers and the primary endpoint was progression free survival by RECIST 1.1. Key secondary endpoints included objective response rate, safety and tolerability.

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, as well as in a Phase 1 trial with Opdivo. 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 December 21, 2018 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in large-scale PCR-based DNA manufacturing, reported the pricing of an underwritten public offering of 5,500,000 shares of its common stock and warrants to purchase up to an aggregate of 5,500,000 shares of the Company’s common stock (Press release, Applied DNA Sciences, DEC 21, 2018, View Source [SID1234532241]). Each share of common stock and each warrant to purchase one share of common stock is being sold at a combined effective price to the public of $0.50.

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Gross proceeds, before underwriting discounts and commissions and estimated offering costs, are expected to be approximately $2.75 million. Applied DNA has granted the underwriter an over-allotment option, exercisable for a period of 45 days, to purchase up to 825,000 additional shares of its common stock and/or 825,000 warrants to purchase common stock at the public offering price less discounts and commissions. The offering is expected to close on or about December 26, 2018, subject to satisfaction of customary closing conditions.

The warrants will be exercisable immediately at an exercise price of $0.50 per share and will expire five years from the date of issuance. The warrants include an adjustment provision that, subject to certain exceptions, reduces their exercise price if the Company issues common stock or common stock equivalents at a price lower than the then-current exercise price of the warrants, subject to a minimum exercise price of $0.14 per share.

Applied DNA intends to use the net proceeds from this offering for working capital, capital expenditures, business development and research and development expenditures.

Maxim Group LLC is acting as sole book-running manager for the offering.

The securities described above are being offered under the Company’s shelf registration statement on Form S-3 (No. 333-218158), previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). The securities were offered by means of a preliminary prospectus supplement and accompanying prospectus, forming a part of the effective registration statement. The final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the website of the SEC at View Source Electronic copies of the prospectus supplement and accompanying prospectus also may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at 212-895-3745. Before you invest, you should read the prospectus supplement and the accompanying prospectus in the registration statement and other documents Applied DNA has filed or will file with the SEC for more complete information about Applied DNA and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On December 20, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a company focused on the
development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T)
technology and gene therapies for rare diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and incurable blood cancer with a median survival of less than 18 months and no standard of care (Press release, Mustang Bio, DEC 20, 2018, View Source [SID1234532176]).

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Martina Sersch, M.D., Ph.D., Chief Medical Officer of Mustang, said, "We are pleased to receive Orphan Drug
Designation for MB-102, which has shown the potential to address an area of high unmet medical need. This significant milestone for Mustang will provide additional market exclusivity and financial benefits to advance MB-102, which we believe is an important new treatment for patients with BPDCN. Based on the Phase 1 data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2017 and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy in November 2018, we expect to initiate a multicenter Phase 1/2 clinical trial in patients with acute myeloid leukemia (AML), BPDCN and high-risk myelodysplastic syndrome in 2019."

MB-102 is currently being studied in a single center, first-in-human Phase 1 dose-escalation clinical trial evaluating the
safety and anti-tumor activity of escalating doses of MB-102 in patients with relapsed or refractory AML (cohort 1) and BPDCN (cohort 2). Patients receive a single dose of MB-102 with an option for a second infusion if they continue to meet safety and eligibility criteria and still have CD123+ disease. MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities.

The FDA grants Orphan Drug Designation to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain incentives, such as tax credits toward the cost of clinical trials and prescription drug user fee waivers. If a product holding Orphan Drug Designation receives the first FDA approval for the disease in which it has such designation, the product is entitled to seven years of market exclusivity, which is independent from intellectual property protection.

About Blastic Plasmacytoid Dendritic Cell Neoplasm
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare and incurable blood cancer with a median survival of less
than 18 months and no standard of care. High levels of CD123 expression is one of the diagnostic hallmarks of BPDCN, making CD123 an attractive target for T cell-based adoptive immunotherapy.

About MB-102 (CD123 CAR T)
MB-102 (CD123 CAR T) is a CAR T cell therapy that is produced by engineering patient T cells to recognize and eliminate CD123-expressing tumors. CD123 is widely expressed on bone marrow cells of patients with myelodysplastic syndromes, as well as in hematologic malignancies including AML, B-cell acute lymphoblastic leukemia, hairy cell leukemia, BPDCN, chronic myeloid leukemia and Hodgkin’s lymphoma.

In the first-in-human clinical trial at City of Hope (NCT02159495), MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities, as reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2017 and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy in November 2018. Dose escalation continues at City of Hope in both indications.

On December 20, 2018 Endocyte, Inc. (Nasdaq:ECYT) ("Endocyte"), a biopharmaceutical company developing targeted therapeutics for cancer treatment, reported that at its Special Meeting of Stockholders held earlier today, Endocyte’s stockholders approved the adoption of the merger agreement pursuant to which Novartis AG will acquire Endocyte for $24 per share, or a total equity value of approximately $2.1 billion, in cash (Press release, Endocyte, DEC 20, 2018, View Source [SID1234532192]).

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Approximately 99.8% of the votes cast at the meeting voted to approve the adoption of the merger agreement, representing approximately 69.5% of Endocyte’s outstanding common stock as of the record date for the Special Meeting of Stockholders.

Subject to the satisfaction of customary closing conditions, the proposed merger is expected to close on or about December 21, 2018.