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 Integra LifeSciences Holdings Corporation, a Delaware corporation (the "Company" or "us") reported that it has entered into a $150 million accounts receivable securitization facility (the "A/R Facility") to reduce outstanding revolving borrowings under the Company’s senior credit facility and to provide additional liquidity and funding for the ongoing business needs of the Company and its subsidiaries (Filing, 8-K, Integra LifeSciences, DEC 21, 2018, View Source [SID1234532306]).

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The documentation for the A/R Facility includes (i) a Receivables Financing Agreement (the "Receivables Financing Agreement") entered into by and among Integra Receivables LLC, a Delaware limited liability company and a newly formed bankruptcy-remote special purpose entity that is an indirect, wholly-owned subsidiary of the Company (the "Borrower"), Integra LifeSciences Sales LLC ("ILS Sales"), as Servicer (the "Servicer"), PNC Bank, National Association, as Administrative Agent, PNC Capital Markets LLC, as Structuring Agent, and certain lenders and group agents that are parties thereto from time to time (the "Lenders"), and (ii) a Purchase and Sale Agreement (the "Purchase and Sale Agreement") by and among ILS Sales, Integra Lifesciences Corporation, and certain other subsidiaries of the Company party thereto from time to time, as Originators (collectively, the "Originators"), the Servicer and the Borrower (collectively, the "Agreements").

Pursuant to the Purchase and Sale Agreement, the Originators have sold or contributed, and will continue to sell and/or contribute on an ongoing basis, certain eligible trade receivables, together with all related security and interests in the proceeds thereof, to the Borrower in exchange for a combination of cash, equity and/or subordinated notes issued by the Borrower to the Originators. Pursuant to the Receivables Financing Agreement, the Borrower may, from time to time, finance such trade receivables with a revolving loan from the Lenders secured by a pledge of such trade receivables, together with all related security and interests in the proceeds thereof.

The Originators and the Borrower provide customary representations and covenants under the Agreements. Receivables in the A/R Facility are subject to customary eligibility criteria, concentration limits and reserves. The Receivables Financing Agreement provides for certain Events of Default, as defined therein, upon the occurrence of which the Administrator may declare the facility Termination Date, as defined therein, to have occurred.

The amount of advances of the Lender outstanding at any one time under the Receivables Financing Agreement is limited to $150 million. As of December 21, 2018, there were $121.2 million of advances outstanding under the A/R Facility. The A/R Facility is for an initial three-year term as may be extended in accordance with the terms of the Receivables Financing Agreement.

ILS Sales serves as the servicer of the trade receivables under the A/R Facility. None of the Company, the Originators or the Borrower guarantees collectability of the trade receivables or the creditworthiness of obligors thereunder. However, the Company has provided a limited guaranty of performance in respect of the obligations of the Originators as originators under the Purchase and Sale Agreement and of the obligations of ILS Sales as servicer under the Receivables Financing Agreement.

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 21, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained regulatory approval for its humanized anti-PD-L1 monoclonal antibody, "TECENTRIQ Intravenous Infusion 1200 mg" (generic name: atezolizumab [genetical recombination]) from the Ministry of Health, Labour and Welfare (MHLW) for additional dosing for the treatment of "previously untreated unresectable advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) (Press release, Chugai, DEC 21, 2018, View Source [SID1234532240])."

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"Following the approval for previously treated NSCLC obtained in January, 2018, we are pleased to gain another approval which enables us to provide a new treatment option as an initial treatment for patients with advanced or recurrent non-squamous NSCLC," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management unit. "Chugai has been conducting five clinical studies in NSCLC in Japan to evaluate TECENTRIQ alone or in combination with other drugs. We are committed to work closely with Roche to provide patients with as many new treatment options as possible to meet their needs."

This approval is based on results from the Phase III IMpower150 study, which showed that TECENTRIQ in combination with AVASTIN and chemotherapy helped people live significantly longer, compared to AVASTIN and chemotherapy. The safety profile of the TECENTRIQ combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified with the combination.

[Reference]
Press release issued by Roche on May 17, 2018
Phase III IMpower150 study showed Roche’s Tecentriq and Avastin plus carboplatin and paclitaxel helped people with a specific type of metastatic lung cancer live significantly longer compared to Avastin plus carboplatin and paclitaxel
View Source

In Japan, the annual prevalence of lung cancer is estimated to be approximately 134,000 in 2015 (male: 91,000, female: 43,000). The annual mortality of lung cancer, the leading cause of cancer death in Japan, is approximately 77,000 (male: 55,000, female: 22,000; predicted figure for 2015).*

As a top pharmaceutical company in oncology in Japan, Chugai is committed to contribute to patients and medical professionals by offering TECENTRIQ as a new treatment option.

Prescribing Information

The underlined part has been newly added and changed.

Product name
TECENTRIQ Intravenous Infusion 1200 mg
Generic name
atezolizumab (genetical recombination)
Indications
Unresectable, advanced or recurrent non-small cell lung cancer
Dosage and administration
In case of patients with untreated unresectable, advanced or recurrent non squamous non-small cell lung cancer.
The usual adult is 1200 mg atezolizumab (genetical recombination) in combination with carboplatin, paclitaxel and bevacizumab (genetical recombination) by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.

In case of patients with unresectable, advanced or recurrent non squamous non-small cell lung cancer who has undergone chemotherapy.
The usual adult dosage is 1200 mg atezolizumab (genetical recombination) administered by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.
Drug price
TECENTRIQ Intravenous Infusion 1200 mg JPY 625,567/per vial
Conditions for approval
1. A risk management plan should be created and appropriately implemented.
2. Because the number of participants in Japanese clinical trials was very limited, post-marketing drug use surveillance of all patients receiving TECENTRIQ treatment should be conducted until data for a certain number of patients have been accumulated, in order to understand background information on people using TECENTRIQ as well as to collect safety and efficacy data on TECENTRIQ promptly, and take necessary measures for the appropriate use of TECENTRIQ.
About TECENTRIQ
In Japan, TECENTRIQ was approved for the indications on "unresectable advanced or recurrent NSCLC" in January, 2018 and was launched in April. In addition, a supplementary application for the first-line treatment of small cell lung cancer was filed in December 7, 2018.

On December 21, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application for humanized anti-PD-L1 monoclonal antibody TECENTRIQ [generic name: atezolizumab (genetical recombination)] to the Ministry of Health, Labour and Welfare (MHLW) for an additional indication of unresectable, locally advanced or metastatic breast cancer and a new 840 mg formulation (Press release, Chugai, DEC 21, 2018, View Source [SID1234532239]).

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This application is based on the results from a global phase III clinical study (IMpassion130 study). The IMpassion130 study is a multicenter, double-blind, randomized, placebo-controlled, global clinical study evaluating the efficacy, safety, and pharmacokinetics of TECENTRIQ in combination with nab-paclitaxel (albumin-bound) compared with nab-paclitaxel alone (albumin-bound) in patients with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer. Co-primary endpoints of this study are progression-free survival per investigator assessment and overall survival. Both primary endpoints are assessed in intent-to-treat (ITT) and PD-L1 positive population. Secondary endpoints are objective response rate, duration of response, and time to deterioration in Global Health Status/Health-Related Quality of Life.

"Triple-negative breast cancer is an aggressive disease with poor prognosis and high unmet medical needs," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. "TECENTRIQ is the first immune checkpoint inhibitor whose efficacy against triple-negative breast cancer has been confirmed. We are committed to deliver atezolizumab to patients as early as possible, and contribute to the realization of better treatment in Japan."

[Reference information]
Roche’s Tecentriq in combination with Abraxane improves outcomes as an initial treatment for people with PD-L1-positive metastatic triple-negative breast cancer (Roche media release dated October 20, 2018)
View Source

About Triple-Negative Breast Cancer
In Japan, 86,500 women (2018 predicted value) are estimated to be afflicted with breast cancer each year. 14,285 women in Japan (2017 predicted value) die as a result of the disease. Triple-negative breast cancer accounts for 15% of all breast cancer cases and, is more common in women under the age of 50, compared with other forms of breast cancer. Triple-negative breast cancer is defined by the lack of expression of hormone receptors (estrogen and progesterone receptors) and the overexpression of human epidermal growth factor receptor 2 (HER2). In general, triple-negative breast cancer has a high tumor-proliferative capacity and shorter overall survival, compared with other forms of breast cancer.

About TECENTRIQ
In Japan, TECENTRIQ was approved for "unresectable and advanced/recurrent non-small cell lung cancer" in January, 2018 and launched in April. Applications for additional indications of first-line treatment of small cell lung cancer were filed, and first-line treatment of non-small cell lung cancer were approved in December, 2018.

References

Cancer Registry and Statistics. Cancer Information Service, National Cancer Center Japan from: View Source Accessed October 2018
Abramson VG et al. Subtyping of triple-negative breast cancer: implications for therapy. Cancer. 2015;121(1):8-16. 3.
Cancer Center. Triple negative breast cancer risk factors. [Internet; cited 2018 May 24]. Available from: View Source Accessed October 2018.
Pal SK et al. Triple negative breast cancer: unmet medical needs. Breast Cancer Res Treat. 2011;125(3):627-636.
American Cancer Society. Breast Cancer Facts & Figures 2013-2014
Lehmann BD et al. Identification of human triple-negative breast cancer subtypes and preclinical models for selection of targeted therapies. J Clin Invest. 2011;121(7):2750-67.