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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.

Bristol-Myers Squibb to Take Part in Evercore ISI HealthCONx Conference

On November 20, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will take part in the Evercore ISI HealthCONx Conference on Tuesday, November 27, 2018, in Boston (Press release, Bristol-Myers Squibb, NOV 20, 2018, https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-take-part-evercore-isi-healthconx-confere [SID1234531566]). Johanna Mercier, head of U.S. and Large Markets, Worldwide Commercial, will answer questions about the company at 11:45 a.m. ET.

Investors and the general public are invited to listen to a live webcast of the session at View Source Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.

Alexion to Present at the Evercore ISI Healthcare Conference

On November 20, 2018 Alexion Pharmaceuticals (Nasdaq: ALXN) reported that management will present at Evercore ISI’s Healthcare Conference in Boston, MA on Tuesday, November 27, 2018 at 8:45 a.m., ET (Press release, Alexion, NOV 20, 2018, View Source [SID1234531565]).

An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

Novelion Therapeutics Announces Leadership Change

On November 20, 2018 Novelion Therapeutics Inc. (NASDAQ:NVLN), reported that General Counsel, Benjamin Harshbarger, has been appointed as interim CEO, reporting to Novelion’s Executive Chair, Mark Corrigan, M.D., effective immediately (Press release, QLT, NOV 20, 2018, View Source [SID1234531564]). Jeffrey Hackman resigned as interim CEO to pursue another opportunity and will stay with the Company in a transitional role until November 30, 2018.

Dr. Corrigan commented, "In the past year, we have made substantial progress in the turnaround of Novelion, and on behalf of the Board of Directors, I’d like to thank Jeff for his dedication to this mission. Importantly, Ben has played a critical role in these initiatives, including the recent loan facility secured by our operating subsidiary, Aegerion Pharmaceuticals, Inc. ("Aegerion"), which we believe positions Aegerion to achieve a more comprehensive capital restructuring – our primary near-term goal. Ben is a long-tenured and trusted leader among Novelion’s employees, and under his guidance we are well-positioned to continue the positive momentum towards fixing our capital structure and driving growth."

Mr. Harshbarger has served as Novelion’s general counsel since November 2016. Prior to that, he served as Aegerion’s acting general counsel, VP, EMEA legal counsel and as vice president, deputy general counsel. Before joining Aegerion in 2012, Mr. Harshbarger served as senior director, corporate counsel at Cubist Pharmaceuticals, Inc. from March 2008 to March 2012, and senior director, deputy general counsel at ViaCell, Inc. from March 2006 to March 2008. Mr. Harshbarger served in several legal positions of increasing responsibility at Biogen Idec from November 2001 to March 2006 and served as an associate at the law firm of Mintz Levin from 1996 to 2001. Mr. Harshbarger holds a J.D. from Boston College Law School and a B.A. from the University of Richmond.

Mr. Harshbarger commented, "With two important rare disease therapies that carry potential for expansion in new markets and indications, we believe we have an opportunity to become a sustainable and growing organization. We are primarily focused on reaching our next critical inflection point: a comprehensive long-term capital restructuring which, if successful, will allow us to take advantage of this growth opportunity while continuing to deliver important therapies to patients."

Entry into a Material Definitive Agreement

On November 19, 2018, MabVax Therapeutics Holdings, Inc. ("MabVax" or the "Company") entered into an Equity Purchase Agreement with Triton Funds LP, an institutional investor ("Triton"), pursuant to which Triton will, subject to the terms of the Equity Purchase Agreement, purchase up to $1 million of the Company’s to be designated 0% Series P Convertible Preferred Stock (such stock, the "Series P Preferred") (Filing, 8-K, MabVax, NOV 20, 2018, View Source [SID1234531563]). Pursuant to the terms of the Equity Purchase Agreement, the Company has the right, but not the obligation, to direct Triton to purchase a number of shares of Series P Preferred (the "Put Shares") at a price per share equal to the stated value of $100.00 per share. The Put Shares are convertible into common stock at the conversion rate of $100 divided by an amount equal to 75% times the volume-weighted average price of the Company’s common stock measured for the five-business day period ending on the business day prior to the Company receiving a conversion notice (the "Conversation Rate"). The Company may direct Triton to purchase Put Shares at any time on or after the date of effectiveness of a registration statement registering the shares of common stock issuable upon conversion of the Put Shares, subject to a maximum of $300,000 for the initial purchase and terms providing the Company may not direct Triton to purchase Put Shares during the 30 day period immediately following delivery of the initial purchase notice. The Equity Purchase Agreement will terminate on the earlier of (i) the date on which Triton has purchased Put Shares with an aggregate purchase price of $1.0 million or (ii) 90 days after the effectiveness of a registration statement registering the shares of common stock underlying the Put Shares.

On November 19, 2018 and in connection with the Equity Purchase Agreement, the Company also entered into a Registration Rights Agreement with Triton pursuant to which the Company agreed to file a registration statement registering for resale the Commitment Shares (defined below) and the shares of common stock issuable upon conversion of the Put Shares. The Company intends on filing a registration statement on Form S-1 in connection with its obligations pursuant to the Registration Rights Agreement.

On November 19, 2018 and in connection with the Equity Purchase Agreement, the Company entered into a Share Donation Agreement pursuant to which the Company agreed to issue 175,000 shares of common stock (the "Commitment Shares") to Triton Funds LLC, manager of Triton, as an inducement to and upon Triton’s execution of the Equity Purchase Agreement.

The Equity Purchase Agreement, Registration Rights Agreement and Share Donation Agreement contain representations, warranties and other provisions customary for transactions of this nature.

In connection with the Equity Purchase Agreement and the issuance of the Put Shares, the Company agreed to file, prior to the issuance of any Put Shares, a Certificate of Designations for the Series P Preferred in the form attached to the Equity Purchase Agreement (the "Series P Certificate of Designations"). Each share of Series P Preferred will be convertible into shares of common stock at the Conversion Rate. This Conversion Rate will be subject to adjustment in the event of stock splits, stock dividends, combination of shares and similar recapitalization transactions. The Company is prohibited from effecting the conversion of shares of the Series P Preferred to the extent that, as a result of such conversion, the holder would beneficially own more than 4.99%, in the aggregate, of the issued and outstanding shares of the Company’s common stock calculated immediately after giving effect to the issuance of shares of common stock upon the conversion of the Series P Preferred (the "Beneficial Ownership Limitation"). The Beneficial Ownership Limitation may be increased by the holder up to, but not exceeding, 9.99%. Each share of Series P Preferred entitles the holder to vote on all matters voted on by holders of common stock. With respect to any such vote, each share of Series P Preferred entitles the holder to cast a number of votes equal to the number of shares of common stock such shares of Series P Preferred Stock are convertible into at such time, but not in excess of the Beneficial Ownership Limitation.

The issuances pursuant to the Equity Purchase Agreement and the Share Donation Agreement are exempt from registration requirements pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) the Securities Act of 1933, as amended (the "Securities Act") and Regulation D under the Securities Act.

The foregoing descriptions of the Equity Purchase Agreement, Series P Certificate of Designations, Registration Rights Agreement and Share Donation Agreement are subject to and qualified in their entirety by the Equity Purchase Agreement, Form of Series P Certificate of Designations, Registration Rights Agreement and Share Donation Agreement attached as Exhibits 10.1, 10.2, and 10.3, respectively.