iCo Therapeutics Announces  Third Quarter 2019 Financial Results

On December 2, 2019 iCo Therapeutics ("iCo" or the "Company") (TSX-V: ICO) (OTCQB: ICOTF), reported financial results for the Quarter ended September 30, 2019. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS") (Press release, iCo Therapeutics, DEC 2, 2019, View Source [SID1234552430]).

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Stated Andrew Rae, President and CEO of iCo Therapeutics Inc., "Several important milestones have been achieved in recent weeks with ethics approval to enter our second oral Amphotericin B ("Oral Amp B") clinical study in Australia and the conclusion of court proceedings in the US and Israel, resulting in approval of Alexion’s asset purchase agreement related to iCo-008, an anti-eotaxin-1 antibody. Moving forward we currently expect the conclusion of the next Oral Amp B clinical study in Q1 2020, immediately followed by a 90-patient Phase 2 study in Q2 2020, comparing Oral Amp B to fluconazole in vulvovaginal candidiasis ("VVC")."

Q3 2019 Financial and Operational Highlights

On August 16, 2019, the Company closed a non-brokered private placement financing issuing 41,200,000 units at $0.05 per unit for aggregate gross proceeds of $2,060,000.
The Company completed its revised ethics submission for a multi-dose, escalation clinical study with its Oral Amp B formulation in healthy volunteers and received ethics approval on November 8, 2019. Screening recently commenced and first patient dosing is expected in December 2019.
On October 21, 2019, the US Court approved a sales order which assigned IMMUNE’s rights and obligations under the IMMUNE License Agreement to Alexion Pharmaceuticals Inc. This approval was followed by the Israeli courts approval of the US driven sales order. Alexion currently expects the sale to close in Q1 2020.

Financial results for Quarter ended September 30, 2019

We incurred a total comprehensive loss of $513,499 for the quarter ended September 30, 2019 compared to a total comprehensive loss of $418,516 for the quarter ended September 30, 2018, representing an increased loss of $94,983. The increase in the loss is primarily the result of higher general and administrative expenses and lower other income offset by lower research and development expenses recognized during 2019.

Research and development expenses were $84,253 for the quarter ended September 30, 2019 compared to $144,773 for the quarter ended September 30, 2018, representing a decrease of $60,520. The decrease related to lower contract research expenses related to the Oral Amp B Phase 1 clinical study. This study was completed in 2018.

With the initiation of the multi-dose, escalation clinical study in healthy volunteers, we expect research and development expenses to increase until the study is completed in Q1 2020. The net cost of this study is expected to be approximately $650,000 taking into consideration tax refunds from the Australian tax authorities related to this study. The Company believes it has sufficient funds to complete this study and initiate the companion 90 patient VVC study.

For the quarter ended September 30, 2019, general and administrative expenses were $440,257 compared to $309,137 for the quarter ended September 30, 2018, representing an increase of $131,120. The increase reflects increased professional fees and management consulting fees during the quarter due to the Company’s participation in the IMMUNE bankruptcy process.

Liquidity and Outstanding Share Capital

As at September 30, 2019, we had cash and cash equivalents of $1,560,866 compared to $10,140 as at December 31, 2018. As at November 29, 2019, we had an unlimited number of authorized common shares with 153,747,713 common shares issued and outstanding.

ASLAN PHARMACEUTICALS ANNOUNCES PROPOSED PUBLIC OFFERING OF AMERICAN DEPOSITARY SHARES

On December 2, 2019 ASLAN Pharmaceuticals (Nasdaq: ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, reported that it has commenced an underwritten public offering of its American Depositary Shares ("ADSs") representing ordinary shares (Press release, ASLAN Pharmaceuticals, DEC 2, 2019, View Source [SID1234551958]). In addition, ASLAN expects to grant the underwriter an option, exercisable at any time through and until one day before the potential closing date of this offering, to purchase up to an additional 15% of the ADSs being offered on the same terms and conditions. All ADSs to be sold in the offering will be offered by ASLAN. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

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ASLAN intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund the clinical development of ASLAN004 and ASLAN003 and for general corporate purposes.

H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

The securities described above are being offered by ASLAN pursuant to a shelf registration statement on Form F-3, including a base prospectus, that was previously filed by ASLAN with the Securities and Exchange Commission (the "SEC") and that was declared effective on November 8, 2019. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Before you invest, you should read the preliminary prospectus supplement and accompanying prospectus and other documents we have filed with the SEC for more complete information about us and this offering. An electronic copy of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or emailing [email protected].

This press release 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 would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Baxter to Expand Advanced Surgery Portfolio with Acquisition of Seprafilm Adhesion Barrier

On December 2, 2019 Baxter International Inc. (NYSE:BAX), a leading global medical products company, reported that it has entered into a definitive agreement to acquire Seprafilm Adhesion Barrier and related assets from Sanofi (Press release, Baxter International, DEC 2, 2019, View Source [SID1234551917]). The agreement is the latest example of Baxter’s continued focus on acquiring products and technologies that have a strong strategic fit with the company’s leading portfolio across the hospital, including in the operating room. The transaction contemplates a cash purchase price at closing of $350 million and is expected to close no later than the first quarter of 2020, following satisfaction of closing conditions.

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"Seprafilm will be a strong complement to our leading hemostat and sealant portfolio, helping us continue to advance the art of healing with optimized patient care in the operating room," said Wil Boren, general manager, Baxter’s Advanced Surgery business. "While Seprafilm is clinically recognized among surgeons globally, we plan to provide commercial support for the product through our dedicated surgery salesforce and pursue opportunities for expansion in certain countries."

Adhesion prevention products, hemostats and sealants are important tools surgeons use to manage intraoperative bleeding and reduce adhesions. Adhesions can occur in any surgery1 when scar tissue develops and binds to nearby tissue. Adhesions can be a source of major post-surgical complications and often require revision, or a second surgery to remove the adhesions. Up to 93% of patients have been shown to develop adhesions following laparotomy,2 a large, surgical incision into the abdominal cavity. Approximately 20% of abdominal surgery patients return for adhesion-related complications, with annual surgical costs of more than $2 billion in the U.S. alone.3

Seprafilm currently has a global commercial presence including sales in the U.S., Japan, China, South Korea and France, among others. Sales of the proposed acquired products are expected to be approximately $100 million in the 12 months following close.

Important Safety Information

Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.

Important Risk Information

Seprafilm Adhesion Barrier is contraindicated in patients with a history of hypersensitivity to Seprafilm and/or to any component of Seprafilm. Seprafilm Adhesion Barrier is contraindicated for use wrapped directly around a fresh anastomotic suture or staple line; as such use increases the risk of anastomotic leak and related events (fistula, abscess, leak, sepsis, peritonitis). The number of sheets used should be just adequate to cover the under surface of the abdominal wall or uterine incision in a single layer. In patients who have ovarian, primary peritoneal or fallopian tube malignancies, Seprafilm use has been reported to have an increased risk of intra-abdominal fluid collection and/or abscess, particularly when extensive debulking surgery was required. The safety and effectiveness of Seprafilm Adhesion Barrier has not been evaluated in clinical studies for the following: Patients with frank infections in the abdominopelvic cavity; patients with abdominopelvic malignancy; device placement in locations other than directly beneath an abdominal wall incision following laparotomy, or directly on the uterus following open myomectomy (not laparoscopic); patients with ongoing local and/or systemic inflammatory cell responses; device use in the presence of other implants, e.g. surgical mesh; patients requiring re-operation within four weeks of Seprafilm placement – during anticipated time of peak adhesion formation. Foreign body reactions have occurred with Seprafilm Adhesion Barrier.

Cellectar Announces Oral Presentation at the 61st Annual American Society of Hematology Conference

On December 2, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported an oral presentation at the 61st Annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting being held December 7-10, 2019 in Orlando, Florida (Press release, Cellectar Biosciences, DEC 2, 2019, View Source [SID1234551916]).

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Presentation details:

Present Title: Fractionated Dosing of CLR 131 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Presenting Author: Dr. Sikander Ailawadhi
Session: 653. Myeloma: Therapy, excluding Transplantation: New Approaches in the Treatment of Relapsed/Refractory Plasma Cell Discrasias
Date/Time: Saturday, December 7, 2019 / 9:30 am – 11:00 am
Location: Orange County Convention Center, Hall E1

A copy of the poster can be accessed on the Posters and Publications section of the Cellectar website on the day of the poster presentation.

Arrowhead Pharmaceuticals Announces Proposed Underwritten Offering of Common Stock

On December 2, 2019 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported its intention to offer and sell 4,000,000 shares of its common stock in an underwritten offering pursuant to its existing automatic shelf registration statement (Press release, Arrowhead Pharmaceuticals, DEC 2, 2019, View Source [SID1234551881]). All of the shares in the proposed offering are to be sold by Arrowhead. Arrowhead intends to grant the underwriters a 30-day option to purchase up to an additional 600,000 shares of its common stock. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Goldman Sachs & Co. LLC, Jefferies LLC and Piper Jaffray & Co. are acting as bookrunning managers for the offering, Cantor Fitzgerald & Co. is acting as passive joint bookrunner for the offering and Robert W. Baird & Co. Incorporated and B. Riley FBR, Inc. are acting as co-managers for the offering. Arrowhead intends to use the net proceeds from this offering for general corporate purposes, including working capital, capital expenditures, research and development expenditures and clinical trial expenditures. A portion of the net proceeds may also be used for the acquisition of complementary businesses, products and technologies, or for other strategic purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") and became automatically effective upon filing on December 2, 2019. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or from Piper Jaffray & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].