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.

On November 20, 2018 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that it will host presentations at two investor conferences in the month of November (Press release, Surface Oncology, NOV 20, 2018, View Source [SID1234531497]).

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Members of the management team of Surface Oncology will participate in a fireside chat at the 30th Annual Piper Jaffray Healthcare Conference, Tuesday, November 27th, 8:30 a.m. ET at the Lotte Palace Hotel, New York City.

Additionally, members of management will participate in the Evercore ISI HealthCONx Conference, Wednesday, November 28, 2:20 p.m. ET at the Boston Harbor Hotel, Boston.

To access the live webcast of these events, please visit the "Events and Presentations" page within the Investors & Media section of the Surface Oncology website at www.surfaceoncology.com. A replay of the webcast will be available on the Surface Oncology website for 90 days following the conferences.

Cautionary Note Regarding Forward-Looking Statements:

Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. These forward-looking statements are based on our management’s current beliefs and assumptions about future events and on information currently available to management.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks and uncertainties related to: our limited operating history and historical losses, our liquidity to fund the development of SRF231 and our other product candidates through current and future milestones, our ability to raise additional funding to complete the development and any commercialization of our product candidates, our dependence on the success of our lead product candidates, SRF231 and NZV930, results from preclinical studies or early clinical trials may not be representative of larger clinical trials, results from the clinical trials and preclinical studies of third parties working in immuno-oncology and our dependence on third parties in connection with our manufacturing, clinical trials and pre-clinical studies. Additional risks and uncertainties that could affect our future results are included in the section titled "Risk Factors" and "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our Prospectus dated April 18, 2018, which is available on the SEC’s website at www.sec.gov and our website at www.surfaceoncology.com.

Additional information on potential risks will be made available in other filings that we make from time to time with the SEC. In addition, any forward-looking statements contained in this press release are based on assumptions that we believe to be reasonable as of this date. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

On November 20, 2018 Synlogic (Nasdaq:SYBX) reported that Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer, will provide a corporate update at the 30th Annual Piper Jaffray Healthcare Conference at 8:30 am ET on Wednesday, November 28, 2018, in New York City (Press release, Synlogic, NOV 20, 2018, View Source [SID1234531515]).

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On November 20, 2018 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, reported that the Company will present at the following upcoming investor conferences (Press release, Scynexis, NOV 20, 2018, View Source [SID1234531498]):

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The 30th Annual Piper Jaffray Healthcare Conference at the Lotte New York Palace Hotel on Tuesday, November 27, 2018 at 10:10 a.m. ET.
The Evercore ISI HealthConX Conference at the Boston Harbor Hotel on Wednesday, November 28, 2018 at 11:45 a.m. ET.
Live webcasts of the presentations will be available on the Investors section of the Company’s website: www.scynexis.com. Replays of the presentations will be available approximately two hours after each event and will be available for two weeks following each presentation.

On November 20, 2018 LEO Pharma, a Danish company specializing in dermatology, and PellePharm, California’s forerunner of rare diseases, reported a strategic development and commercialization collaboration to address unmet medical needs various skin diseases without approved drugs and to promote innovation and access to potential therapies for patients with life-changing diseases such as Gorlin-Goltz syndrome and high-frequency basal cell carcinoma (BCC), two distinct and rare skin cancers (Press release, Leo, NOV 20, 2018, View Source [SID1234531516]).

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" We are very pleased to partner with PellePharm, the pioneers of Gorlin-Goltz Syndrome and experts in rare skin diseases. It supports our ambitious strategy for 2025 and marks the entry of LEO Pharma into the field of rare skin diseases. It also provides a unique opportunity to further develop the first compound to treat people with very severe skin conditions who are currently not receiving any therapies, "said Thorsten Thormann, Vice President of Research at LEO Pharma.

Under the terms of the agreement, LEO Pharma has initially committed $ 70 million of equity and research and development R & D to support the global Phase 3 study for the topical gel, patidegib, 2% To finance the prevention and treatment of Gorlin-Goltz syndrome, with LEO Pharma securing an option to acquire all of its shares in PellePharm. In addition, PellePharm and its shareholders could receive up to $ 690 million including a merger payment and milestone payments for approval and commercialization. In addition, after achieving certain commercial milestones, PellePharm shareholders are entitled to a double-digit royalty payment.

" Our company is committed to fighting rare dermatological diseases at the source and providing patients with new breakthrough treatments as efficiently and effectively as possible. As the world leader in the field of medical dermatology, LEO Pharma is the ideal development and marketing partner. This collaboration paves the way for our pivotal Phase 3 Gorlin-Goltz syndrome study in early 2019. Following the potential merger, we look forward to working with LEO Pharma on other rare skin diseases with unmet needs, "said Sanuj Ravindran, President and Chief Executive Officer of PellePharm.

Under the terms of the agreement, a Joint Development Committee will be set up, where PellePharm will be responsible for global development and LEO Pharma will have an advisory role. Both companies will jointly push ahead with marketing planning and LEON Pharma’s Chief Financial Officer Anders Kronborg will join PellePharm’s Board of Directors.

"The Gorlin Syndrome Group welcomes the news about the collaboration between PellePharm and LEO Pharma in developing patidegib with topical application for BCC treatment. Data from the PellePharm Phase 2 study suggest that patidegib is an effective BZK treatment with minimal side effects. We hope that by working with LEO these benefits will be confirmed in a Phase 3 study. An effective topical treatment for the prevention or treatment of BCC could prevent the painful, disruptive and disfiguring surgical procedures that we are currently undergoing, "said Sally Webster, chairperson, and Matthew Helbert, trustee of the Gorlin Syndrome Group UK

There are currently no FDA-approved therapies for Gorlin-Goltz syndrome and surgery is the treatment standard for this rare disease. Sometimes patients with this lifelong, serious illness have to undergo up to 30 surgeries per year from the middle age of teens.

PellePharm’s topical formulation (2%) is expected to be the first approved therapy for the prevention of Gorlin-Goltz syndrome, also known as nevoid cell basal cell carcinoma nevus syndrome (BCCNS), and has entered Phase 2 clinical trials has shown promise in treating patients with Gorlin-Goltz syndrome and sporadic BCC in the US and the UK.

" For more than 18 years, our organization has been dedicated to helping, educating, and finding much-needed preparations for people with Gorlin-Goltz Syndrome (BCCNS), and yet there are still no FDA-approved therapies for this serious disease," said Jean Pickford, executive director of the BCCNS Alliance. " Especially against the background of the Patidegib Phase 3 trial, which will begin recruitment in early 2019, PellePharm’s commitment – now in partnership with LEO Pharma – is very encouraging to our community."

PellePharm was advised by Rothschild & Co. on this transaction.

About Patidegib

The topical gel patidegib has been shown to be promising in a phase 2 clinical trial for the relief of BZK tumors in Gorlin-Goltz syndrome by blocking the hedgehog signaling pathway and thereby controlling the disease at the source. The topical formulation of patidegib is expected to achieve the efficacy already demonstrated for oral patidegib in Phase 1 studies without the occurrence of negative systemic side effects. The gel formulation is stable at room temperature for at least two years, so this could be a realistic treatment option for ongoing home-based treatment of Gorlin-Goltz syndrome and high-frequency BCC.

Über das Gorlin-Goltz-Syndrom

Das Gorlin-Goltz-Syndrom ist eine seltene, genetisch bedingte Krankheit, die durch konstitutionelle, vererbbare Mutationen in einem Allel des Tumorsuppressorgens PATCHED1 (PTCH1) gekennzeichnet ist, das als primärer Inhibitor des Hedgehog-Signalwegs wirkt. Dadurch bilden sich meist im Gesicht mehrere Basalzellkarzinome.

Because there are no FDA-approved drugs for Gorlin-Goltz syndrome, surgery is the standard of care. It may happen that people with severe Gorlin-Goltz syndrome have to undergo up to 30 surgeries per year, which often have to be repeated and may be associated with scarring and disfigurement. It is estimated that around 10,000 people in the United States and one in 31,000 people are affected by Gorlin-Goltz syndrome. Gorlin-Goltz Syndrome is also referred to as Gorlin Syndrome, Basal Cell Nevus Syndrome (BCNS), and Naso-Bold Cell Carcinoma Syndrome (NBCCS).

About radiofrequency basal cell carcinoma (BCC)

High-frequency BCC, like Gorlin-Goltz syndrome, is a rare disease characterized by the development of an unusually high BCC number. In contrast to patients with Gorlin-Goltz syndrome, patients with radiofrequency BCC are not born with a germ-line mutation in the PTCH1 gene and do not suffer from the other systemic manifestations of Gorlin-Goltz syndrome. The standard of care for patients with radiofrequency BCC is surgery.