On November 8, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center, reported the appointment of Dr. Sandra Silberman as Chief Medical Officer ("CMO") in charge of New Products (Press release, Moleculin, NOV 8, 2017, View Source;-new-products [SID1234521745]).

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"Dr. Silberman is a highly experienced, well-esteemed oncologist and CMO," commented Walter Klemp, Chairman and CEO of Moleculin. "Among her many accomplishments, she was the project leader for Gleevec, a blockbuster cancer drug. We’ve benefitted from her guidance during her time on our Science Advisory Board, but as we have gained momentum with our WP1066 and WP1122 Portfolios, we now need the focus of a highly qualified CMO. We are honored to have such an accomplished physician leading these planned clinical projects."

Mr. Klemp concluded, "This appointment allows Dr. Robert Shepard, our CMO in charge of Hematology, to devote his full attention to the clinical trials of Annamycin."

Dr. Silberman’s career in clinical development began at Pfizer, Inc., where she oversaw the initiation of Tarceva clinical trials. She then led the global development of Gleevec at Novartis. Sandra was the first Vice President and Global Therapeutic Area Head in Oncology at Eisai, a role in which she advanced five original compounds into Phases I through III, gaining the first approval for Eisai’s proprietary drug, Halavan. Subsequently, she served as a senior advisor to a number of biopharmaceutical companies, including Bristol-Myers Squibb, AstraZeneca, Imclone, Roche, and numerous biotech companies as an independent industry consultant. She joined Quintiles in 2009 as the Vice President of Oncology and Global Head of Translational Medicine in the newly formed Innovation division, overseeing drug development and novel technologies for new partnerships with the pharmaceutical and biotechnology industries. Sandra earned her B.A., Sc.M. and Ph.D. from the Johns Hopkins University School of Arts and Sciences, School of Public Health and School of Medicine, respectively. Her major focus of investigation and doctoral thesis was in the burgeoning area of tumor immunology. She received her M.D. from Cornell University Medical College, completing a postdoctoral training and her fellowship in hematology/oncology at the Brigham & Women’s and the Dana Farber Cancer Institute in Boston. She continued to do research in tumor immunology with a clinical investigator award from the NIH and became an Instructor in Medicine at Harvard Medical School. She then served as an attending physician at Yale University Hospital. Sandra has continued in clinical practice throughout her career in industry, and is currently an attending physician in the Hematology/Oncology clinic at the Duke VA in Durham, NC.

Provectus Biopharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Provectus Biopharmaceuticals, 2017, NOV 8, 2017, View Source [SID1234521780]).

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Lipocine has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Lipocine, 2017, NOV 8, 2017, View Source [SID1234521825]).

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On November 8, 2017 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported consolidated financial results for the third quarter ended September 30, 2017 (Press release, Pacira Pharmaceuticals, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315327 [SID1234521756]).

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"We continue to make important progress during 2017 as we advance our strategy to expand the role of EXPAREL as the only long-acting local analgesic capable of providing non-opioid pain control during the most intense period of postsurgical pain," said Dave Stack, chairman and chief executive officer of Pacira. "Recent highlights include the FDA acceptance of our sNDA for nerve block; the publication of new research quantifying the devastating impact of opioids for postsurgical pain; a unique collaboration with Aetna to reduce opioid use associated with impacted wisdom teeth extractions; and the advancement of our important partnership with J&J."

"During the quarter we generated year over year EXPAREL growth despite fewer selling days and the impact of weather in areas of the southern United States representing about 20 percent of our business. From our commercial initiatives and current trends however; we remain confident in the growth potential of EXPAREL and our steadfast commitment to reducing the use of opioids for postsurgical pain."

Recent Highlights

U.S. Food and Drug Administration (FDA) Acceptance of Supplementary New Drug Application for Nerve Block. In October, the FDA accepted the company’s resubmission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL (bupivacaine liposome injectable suspension) label to include administration via nerve block for prolonged regional analgesia. If approved, EXPAREL could help eliminate the need for cumbersome devices like pumps and catheters and shift numerous procedures to an outpatient setting. The expected action date for the FDA under the Prescription Drug User Fee Act (PDUFA) is April 6, 2018.
Provided Invited Testimony at White House Opioid Crisis Commission Meeting. In September, Pacira Chief Executive Officer Dave Stack testified before President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis. The Commission, led by New Jersey Governor Chris Christie, was created to study ways to combat and treat drug abuse, addiction and the opioid crisis. Stack provided insights into the critical nature of clinician and patient access to non-opioid medications that can effectively manage postsurgical pain while reducing opioid requirements.
Published New Research Highlighting Serious Threats Associated with Overprescribing Postsurgical Opioids. Newly published research, conducted by the QuintilesIMS Institute, shows individuals undergoing surgery are at particular risk for long-term opioid use. An overwhelming majority of patients (nine in 10) are exposed to opioids to manage postsurgical pain, and those given prescriptions received an average of 85 pills each. In addition, nearly 3 million individuals who had surgery in 2016 became persistent opioid users, according to the research. This report, The United States for Non-Dependence, represents the most current analysis of national trends in opioid prescribing.
Collaboration with Aetna and the American Association of Oral and Maxillofacial Surgeons to Reduce Opioid Use. In September, Pacira announced a nationwide collaboration with Aetna and the American Association of Oral and Maxillofacial Surgeons (AAOMS) aimed at reducing the number of opioid tablets prescribed to patients undergoing impacted third molar extraction by at least 50 percent through the utilization of EXPAREL to provide prolonged non-opioid postsurgical pain control.
Multiple EXPAREL Data Presentations at the New York School of Regional Anesthesia Annual Fall Symposium. In September, the company presented three posters evaluating the use of EXPAREL administered as a regional nerve block to manage postsurgical pain at the New York School of Regional Anesthesia’s (NYSORA) 16th Annual Symposium on Regional Anesthesia, Pain and Perioperative Medicine.
Third Quarter 2017 Financial Results

EXPAREL net product sales were $66.8 million in the third quarter of 2017, a 3% increase over the $64.9 million reported for the third quarter of 2016. There were two fewer selling days in the third quarter of 2017 compared to the third quarter of 2016.
Total revenues were $67.3 million in the third quarter of 2017, a 1% decrease versus the $68.4 million reported for the third quarter of 2016, primarily related to the discontinuation of DepoCyt(e) and lower collaborative licensing and milestone revenue.
Total operating expenses were $70.9 million in the third quarter of 2017, compared to $89.2 million in the third quarter of 2016.
GAAP net loss was $7.6 million, or $(0.19) per share (basic and diluted), in the third quarter of 2017, compared to a GAAP net loss of $22.2 million, or $(0.59) per share (basic and diluted), in the third quarter of 2016.
Non-GAAP net income was $4.4 million, or $0.11 per share (basic and diluted) in the third quarter of 2017, compared to non-GAAP net income of $8.0 million, or $0.22 per share (basic) and $0.20 per share (diluted), in the third quarter of 2016.
Pacira ended the third quarter of 2017 with cash, cash equivalents, short-term and long-term investments ("cash") of $374.9 million.
Pacira had 40.5 million basic weighted average shares of common stock outstanding in the third quarter of 2017.
For non-GAAP measures, Pacira had 41.4 million diluted weighted average shares of common stock outstanding in the third quarter of 2017.
2017 Outlook

Pacira is updating its full year 2017 sales guidance and reiterating its remaining financial guidance as follows:

EXPAREL net product sales of $280 million to $285 million from its previously guided range of $290 million to $310 million.
Non-GAAP gross margins of approximately 70%.
Non-GAAP research and development (R&D) expense of $50 million to $60 million.
Non-GAAP selling, general and administrative (SG&A) expense of $145 million to $155 million.
Stock-based compensation of $30 million to $35 million.
See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2017 Financial Guidance" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, November 8, 2017, at 8:30 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 96590192.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 96590192. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income (loss), non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D), non-GAAP selling, general and administrative (SG&A) and non-GAAP product discontinuation expenses, because such measures exclude stock-based compensation, amortization of debt discount, loss on early extinguishment of debt, a contract termination fee with CrossLink BioScience, LLC, or CrossLink, exit costs related to the discontinuation of DepoCyt(e) production and inventory and related reserves from 2016.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D and SG&A outlook for 2017 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2017 financial guidance for gross margins, R&D and SG&A.

On November 8, 2017 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported a corporate progress update and reported financial results for the quarter ended September 30, 2017 (Press release, MacroGenics, NOV 8, 2017, View Source [SID1234521799]).

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"We continue to be encouraged by data we’ve seen across multiple product candidates in our diverse pipeline. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting later this week, we will have five posters relating to our various PD-1-based programs, including MGA012 (anti-PD-1) and our two PD-1-based DART molecules," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Also, in addition to the Phase 1 flotetuzumab data presented recently at the European Society for Medical Oncology Annual Congress (ESMO) (Free ESMO Whitepaper), we look forward to having two posters and an oral presentation with updated clinical data, at the 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December. Finally, we are thrilled to work with our new collaboration partner, Incyte, to expand the current development efforts for MGA012 and accelerate our own efforts to investigate combinations of MGA012 with multiple molecules in MacroGenics’ portfolio."

Key Pipeline Highlights

Flotetuzumab. Enrollment of the Phase 1 dose expansion study of flotetuzumab, a bispecific DART molecule that recognizes both CD123 and CD3, is ongoing in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Recent highlights include:

In September, MacroGenics presented clinical data from its ongoing Phase 1 study of flotetuzumab in an oral session at ESMO (Free ESMO Whitepaper). Flotetuzumab demonstrated acceptable tolerability in the dose escalation portion of the study with encouraging initial anti-leukemic activity observed in AML patients. As of the data cut-off date of August 1, of the 14 response-evaluable patients treated at the threshold dose, six (43%) experienced an objective response. This included four (28%) patients who achieved a CR/CRi, with one patient who had a molecular CR.
MacroGenics will present updated clinical data in an oral presentation at ASH (Free ASH Whitepaper) in December 2017.
PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing several PD-1-directed programs, which are designed to enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. The first of these are:

MGA012. Enrollment in the dose escalation portion of the Phase 1 study of this anti-PD-1 antibody has been completed and the data have been accepted for poster presentation at the upcoming SITC (Free SITC Whitepaper) meeting. MGA012 is currently being evaluated as monotherapy across four solid tumor types in the dose expansion portion of the Phase 1 study. In October 2017, MacroGenics entered into an exclusive global collaboration and license agreement with Incyte Corporation for MGA012, in which Incyte obtained exclusive worldwide rights for the development and commercialization of MGA012. MacroGenics retains the right to pursue its core strategy to develop its pipeline assets in combination with MGA012. The Company plans to initiate the first study of MGA012 in combination with another internal program by year end 2017.
MGD013. MacroGenics is developing MGD013, a DART molecule, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of malignancies. The Company is enrolling the dose escalation portion of the Phase 1 study and will present a preclinical data poster as well as a Trials-in-Progress poster describing the Phase 1 study at SITC (Free SITC Whitepaper).
MGD019. MacroGenics continues to advance a preclinical bispecific DART molecule that provides co-blockade of PD-1 and CTLA-4, resulting in enhanced T-cell activation. The Company is conducting activities to support the potential submission of an Investigational New Drug (IND) application for MGD019 in 2018 and will present a preclinical data poster at SITC (Free SITC Whitepaper).
B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. These molecules include:

Enoblituzumab: The Company and collaborators continue to recruit patients in multiple ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include a combination study with an anti-PD-1 antibody and a neoadjuvant prostate cancer study.
MGD009: This DART molecule targets B7-H3 and CD3 and is being evaluated in a Phase 1 study across multiple solid tumor types. The Company continues to explore the dose and schedule for MGD009 administration.
MGC018: The Company is conducting activities to support the potential submission of an IND application for this anti-B7-H3 antibody drug conjugate in 2018.
Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:

Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. MacroGenics believes it is on track to complete and announce the results of an interim futility analysis by year-end 2017 or early 2018 and to complete enrollment of this study by late 2018.
Phase 2 Gastric Cancer Study. The Company continues to enroll advanced HER2-positive gastric and gastroesophageal junction cancer patients in its combination study of margetuximab with an anti-PD-1 antibody. MacroGenics expects to complete enrollment of two 30 patient expansion cohorts in 2017 and present clinical data during the first half of 2018.
Additional DART Clinical Programs. Other DART molecules being led by MacroGenics in Phase 1 clinical development include MGD007 (gpA33 x CD3) for colorectal cancer and MGD014 (HIV x CD3) for HIV. Updates on these programs include:

MGD007. MacroGenics continues to recruit patients with colorectal cancer in a Phase 1 study and is evaluating various expansion cohorts to define a recommended dose and schedule.
MGD014. MacroGenics’ IND submission for MGD014 was cleared by FDA and the Company anticipates that a first patient will be dosed in early 2018.
Corporate Update

Incyte Collaboration. In October 2017, MacroGenics and Incyte Corporation entered into an exclusive global collaboration and license agreement for MGA012. Under this agreement, MacroGenics will receive an upfront payment of $150 million and could receive up to $750 million in potential development, regulatory and commercial milestones. If MGA012 is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 percent to 24 percent, on future sales of MGA012 by Incyte. The transaction is expected to close in the fourth quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act and customary closing conditions.
GMP Manufacturing. Construction progress on MacroGenics’ GMP manufacturing suite remains on track. The Company anticipates that the 5 x 2,000 liter single-use bioreactor facility will be operational in 2018. As part of the MGA012 collaboration with Incyte, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012.
Third Quarter 2017 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2017, were $203.6 million, compared to $285.0 million as of December 31, 2016. MacroGenics anticipates receipt of the $150 million upfront payment from Incyte upon closing of the transaction in the fourth quarter of 2017.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $1.7 million for the quarter ended September 30, 2017, compared to $3.3 million for the quarter ended September 30, 2016. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the period.
R&D Expenses: Research and development expenses were $41.0 million for the quarter ended September 30, 2017, compared to $30.3 million for the quarter ended September 30, 2016. This increase was primarily due to the initiation of the MGA012 Phase 1 study and continued enrollment in multiple ongoing clinical trials.
G&A Expenses: General and administrative expenses were $8.4 million for the quarter ended September 30, 2017, compared to $7.2 million for the quarter ended September 30, 2016. This increase was primarily due to increased professional fees, including consulting expenses, and increased employee compensation and benefit expense to support our overall growth.
Net Loss: Net loss was $47.0 million for the quarter ended September 30, 2017, compared to net loss of $33.8 million for the quarter ended September 30, 2016.
Shares Outstanding: Shares outstanding as of September 30, 2017 were 36,807,112.
Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended September 30, 2017 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (+1) (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 5477659.

The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.