Heat Biologics, Inc. Announces Proposed Public Offering

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.

Adhera Therapeutics Provides Third Quarter 2018 Financial Results and Business Update

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.

Immunocore to co-develop IMC-C103C, a T cell redirecting bi-specific biologic, with Genentech

On November 19, 2018 Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company focused on delivering first-in-class biological therapies that have the potential to transform lives of people with serious diseases, reported it has entered into a new partnership with Genentech, a member of the Roche Group, to expand an existing discovery collaboration (Press release, Immunocore, NOV 19, 2018, View Source [SID1234531435]).

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Genentech and Immunocore will now co-develop Immunocore’s therapeutic candidate IMC-C103C, an ImmTAC molecule targeting tumours that express the protein MAGE-A4 (Melanoma-Associated Antigen A4).

Under the terms of the agreement, Immunocore will lead the first-in-human clinical trial to establish safety and preliminary efficacy of IMC-C103C as both monotherapy and in combination with atezolizumab (Tecentriq). The clinical trial, which is scheduled to commence in early 2019, will enrol patients across a number of solid tumour types. As part of the agreement, Genentech will pay Immunocore $100 million in upfront and near-term milestone payments. Upon establishing proof-of-concept data, Immunocore retains an option to continue to co-develop IMC-C103C through commercialisation, or to fully license the candidate to Genentech in return for royalty and milestone payments.

Andrew Hotchkiss, CEO of Immunocore, said: "MAGE-A4 is a known cancer-associated antigen expressed in a wide range of malignancies. Genentech is a leader in oncology with extensive immunology expertise, with whom we’ve had a good collaborative relationship for several years. We look forward to embarking upon this new partnership to investigate whether IMC-C103C could ultimately improve the lives of people with MAGE-A4 positive cancers."

James Sabry, M.D., Ph.D., Global Head of Pharma Partnering, Roche, commented: "We’ve had a very productive collaboration with Immunocore since we began our initial partnership in 2013. We’re excited to move this first molecule forward, both as a single agent and in combination with Tecentriq, and to further explore the role of T cell receptor-directed medicines in fighting cancer."

ArQule to Present Clinical Data for its BTK Inhibitor, ARQ 531, at the 2018 American Society of Hematology (ASH) Annual Meeting

On November 19, 2018 ArQule, Inc. (Nasdaq:ARQL) reported that it will present clinical data on the company’s BTK inhibitor, ARQ 531, in a poster presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held from December 1 to 4, 2018 in San Diego (Press release, ArQule, NOV 19, 2018, View Source [SID1234531436]).

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Updated safety, PK, biomarker and anti-tumor activity data from the company’s Phase 1 dose escalation study in patients with relapsed or refractory hematologic malignancies (ARQ 531-101) will be presented.

Presentation Details

Title: A Phase 1 Dose Escalation Study of ARQ 531 in Selected Patients with Relapsed or Refractory Hematologic Malignancies

Abstract #: 3136
Session: CLL: Therapy, excluding Transplantation: Poster II
Date: Sunday, December 2, 2018
Time: 6:00-8:00 p.m. PT
Location: San Diego Convention Center, Hall GH

About BTK and ARQ 531
Bruton’s tyrosine kinase, BTK, is a therapeutic target that has been clinically proven to inhibit B-cell receptor signaling in blood cancers. ARQ 531 is an orally bioavailable, potent and reversible BTK inhibitor. Biochemical and cellular studies have shown that ARQ 531 inhibits both the wild type and C481S-mutant forms of BTK. The C481S-mutation is a known resistance mechanism for first generation irreversible BTK inhibitors. In preclinical studies, ARQ 531 has demonstrated good oral bioavailability as well as favorable pharmacokinetic, pharmacodynamic and metabolic properties.

Myriad Announces $50 Million Accelerated Share Repurchase Program

On Npvember 19, 2018 Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, reported that the company has entered into an accelerated share repurchase ("ASR") agreement with Bank of America, N.A. under which the company will repurchase approximately $50 million of its common stock (Press release, Myriad Genetics, NOV 19, 2018, View Source [SID1234531482]). Myriad currently has approximately $161 million remaining on its existing share repurchase authorization which has been approved by the company’s board of directors.

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"We remain highly confident in the future growth prospects for the company and believe repurchasing shares at current levels will generate a very attractive return on invested capital," said R. Bryan Riggsbee, chief financial officer, Myriad Genetics. "Given our strong balance sheet, we continue to be flexible in our capital deployment, and while we prioritize strategic acquisitions, we will opportunistically consider share repurchases if stock valuation is inconsistent with long-term fundamentals."

Under the ASR program, Myriad will pay an aggregate of approximately $50 million to Bank of America, N.A. to repurchase a number of shares that will be based on a discount to the volume-weighted average share price of its common stock over the course of a valuation period.