On November 20, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that the U.S. Food and Drug Administration (FDA) has granted the Biological Product Designation for AGI-134, the Company’s novel immunotherapy compound (Press release, BioLineRx, NOV 20, 2018, View Source;p=RssLanding&cat=news&id=2377772 [SID1234531480]). This designation provides the Company with eligibility to obtain 12 years of market exclusivity upon approval of the product for commercial use by the FDA. This regulatory market exclusivity adds an incremental layer of protection in addition to that afforded by existing patents granted in the United States and Europe, and pending in other countries, covering the use of AGI-134 for the treatment of solid cancer tumors. These patents are valid until May 2035, with a possible term extension of up to five additional years.

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"We are extremely pleased to receive the FDA’s Biological Product Designation for AGI-134, our second lead oncology asset. This classification as a biological product is very significant, since it provides us with additional valuable exclusivity and confirms the FDA’s acceptance of AGI-134’s main mechanism of action as a vaccine," said Philip Serlin, Chief Executive Officer of BioLineRx. "Pre-clinical studies have demonstrated that treatment with AGI-134 leads to complete regression of primary tumors, prevents growth of untreated distal secondary tumors, and triggers a vaccine effect that may prevent the development of future metastases. Furthermore, in prior studies, the combination of AGI-134 with an anti-PD-1 immune checkpoint inhibitor demonstrated a synergistic effect in protection from secondary tumor growth. We recently initiated a Phase 1/2a study of this promising product in solid tumors, as both monotherapy and in combination with checkpoint inhibitors, and we anticipate initial top-line results from this important study by the end of 2020."

About AGI-134

AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intratumoral administration, thereby targeting the body’s pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. Binding of anti-Gal antibodies to the treated tumors results in activation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient’s own tumor neo-antigens.

AGI-134 has been evaluated in numerous pre-clinical studies. In a mouse melanoma model, treatment with AGI-134 led to regression of established primary tumors and suppression of secondary tumor (metastases) development. Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.

On November 20, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the company will present at the 30th Annual Piper Jaffray Healthcare Conference in New York, NY. The presentation is scheduled for 8:00 AM EST on Wednesday, November 28, 2018 (Press release, BeiGene, NOV 20, 2018, View Source;p=irol-newsArticle&ID=2377771 [SID1234531496]).

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A live webcast can be accessed from the investors section of BeiGene’s website at View Source An archived replay will be available for 90 days following the event.

On November 20, 2018 Exelixis, Inc. (NASDAQ: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide an overview of the company at the following investor conferences in November (Press release, Exelixis, NOV 20, 2018, View Source [SID1234531514]):

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The 30th Annual Piper Jaffray Healthcare Conference: Exelixis is scheduled to present at 11:00 AM EST / 8:00 AM PST on Tuesday, November 27, 2018 in New York.
Evercore ISI HealthConX: Exelixis is scheduled to present at 2:00 PM EST / 11:00 AM PST on Wednesday, November 28, 2018 in Boston.
To access the webcast links, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to each presentation to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for 14 days.

On November 20, 2018 HEATBIOLOGICS, INC. (NASDAQ: HTBX), a biopharmaceutical company developing immunotherapies with the goal of activating a patient’s immune system against cancer through T-cell activation, reported that it intends to offer for sale its common stock and warrants to purchase shares of its common stock in an underwritten public offering (Press release, Heat Biologics, NOV 20, 2018, View Source [SID1234531538]). Heat Biologics, Inc. intends to use the net proceeds from this offering to fund, among other things, its and its subsidiaries’ preclinical and clinical programs and for working capital and general corporate purposes, including, to acquire, license or invest in complementary businesses, technologies, product candidates or other intellectual property. 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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A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-221201) previously filed with the U.S. Securities and Exchange Commission (the ”SEC”). A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2006 or email: [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Heat Biologics, Inc. has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Heat Biologics, Inc. and such offering.

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.

On November 20, 2018 Adhera Therapeutics, Inc. (OTCQB: ATRX), an emerging specialty pharmaceutical company commercializing therapies that leverage its innovative distribution model and technology to improve the quality of care for patients suffering from chronic and acute diseases, reported financial and operating results for the third quarter of 2018 today (Press release, Marina Biotech, NOV 20, 2018, View Source [SID1234531579]).

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"The third quarter represented a strategic shift away from R&D and into commercialization," stated Robert Moscato, Jr., Chief Executive Officer of Adhera Therapeutics. "We have strategically positioned the company and changed the corporate identity while building a high-performance culture and streamlining communication. We hired a leadership team with a proven track record of building healthcare companies and commercializing life changing products, appointed new members to the Board of Directors to support the innovative business plan, recruited and trained an assiduous sales team and launched our first commercial product – PRESTALIA."

Recent Corporate Highlights

●The third quarter of 2018 marked the first full quarter of PRESTALIA sales in the United States. PRESTALIA, a fixed dose combination of perindopril arginine (an angiotensin-converting-enzyme inhibitor) and amlodipine besylate (a calcium channel blocker), was developed in coordination with Servier Laboratories, an international pharmaceutical company and global leader in the treatment of hypertension with turnover of €4.152 billion in 2017. The product is sold outside the United States under the brand name – Viacoram. Sales of Viacoram exceed $300 million annually. In the United States, PRESTALIA is distributed through our innovative distribution model and supported through PrestaliaDirect. Powered by Adhera’s DyrctAxess technology, PrestaliaDirect is a patient membership program that caps blood pressure medication costs, provides monitoring devices, offers online tracking tools and ships prescriptions directly to the patient. The sales performance of Viacoram in Europe does not necessarily indicate the potential sales performance of PRESTALIA by Adhera Therapeutics in the United States.

The Company moved its headquarters to Research Triangle Park, NC, began building its commercial team and broadening its Board of Directors to align with the innovative business plan.

The Company made key hires to strengthen the leadership team with the addition of Robert Moscato, Jr., former President and COO of Cerecor, Inc. named Chief Executive Officer, Eric Teague, former CFO and Board Member of ARCA, named Chief Financial Officer, and Jay Schwartz, former Vice President, Client Engagement Head for the Integrated Engagement Services division of IQVIA , named Sr. VP of Commercial Operations.

The Company appointed Uli Hacksell, Ph.D. and Nancy R. Phelan as members of its Board of Directors. Dr. Hackell serves as the Chairman of the Board of Directors and Ms. Phelan serves as a member of the audit committee. Both Dr. Hacksell and Ms. Phelan bring a bevy of pharmaceutical commercial and development experience to the company. Dr. Hacksell serves as Chairman of the Board of Directors of Cerecor Inc., he was previously President and Chief Executive Officer of Cerecor Inc., the Chief Executive Officer and a director of ACADIA Pharmaceuticals Inc. as well as Vice President of Drug Discovery and Technology, and President of Astra Draco AB, one of Astra’s largest research and development subsidiaries. Ms. Phelan is the Chief Business Officer of Innate Biologics as well as an Independent Board Member for FemmePharma Consumer Healthcare, Advisory Board Member for Eved, and a member of the Pharma Digital Health Roundtable Steering Committee. Ms. Phelan was Senior Vice President, Commercial Growth at Outcome Health, the Vice President, U.S. Customer Strategy and Operations and Head, Worldwide Commercial Operations for Bristol-Myers Squibb Company and held leadership roles in global and U.S. marketing at Wyeth, which was acquired by Pfizer Inc. in 2009.
The company hired a 20-person sales team and deployed transformational technology to connect across all commercial functions. This state-of-the-art approach will help maximize our ability to educate healthcare providers and improve patient outcomes.

Third Quarter Financial Results

We recorded $0.08 million in net sales for the three months ended September 30, 2018, as compared to no revenues for the three months ended September 30, 2017. In the first few months of launch, we sold over 500 bottles of PRESTALIA to our pharmacy partners. The strong initial demand for Prestalia was generated by more than 150 physicians writing over 600 prescriptions in the first few months of commercialization.

Total operating expenses increased by $6.81 million for the third quarter of 2018 as compared to the same period in 2017. The increase was primarily due to $4.79 million in Goodwill and intangible asset impairments, a $1.46 million increase in General and Administrative expenses, and a $0.87 million increase in sales, marketing, and commercial operations expenses. The increase in General and Administrative costs is primarily due to $1.31 million of compensation expense related to stock options granted to new members of the management team and the Board of Directors.

The net loss for the three months ended September 30, 2018 was $7.78 million compared to $0.97 million for the three months ended September 30, 2017. This change was due primarily to the $6.81 million increase in total operating expenses during the third quarter of 2018.

As of September 30, 2018, we had cash of $6.51 million, compared to cash of $0.11 million at December 31, 2017. The improvement in the cash balance was mainly due to the private placement of our newly created Series E and Series F Convertible Preferred Stock offerings during the second and third fiscal quarters of 2018. The Company also recorded $0.13 million and $0.36 million of accounts receivable and inventory, respectively, as of September 30, 2018. These amounts are related to the commercialization of Prestalia, and there were no accounts receivable or inventory as of December 31, 2017. Total current liabilities decreased by $3.55 million between December 31, 2017 and September 30, 2018, as the company paid off $1.91 million in notes payable and $1.18 million in amounts due to related parties. The company had no significant long-term liabilities as of September 30, 2018.