On February 28, 2018 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") reported its progress and activity at the recently concluded BMT Tandem Meetings, the combined annual meetings of the American Society of Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) (Press release, Actinium Pharmaceuticals, FEB 28, 2018, View Source [SID1234524220]). Actinium’s lead product candidate, Iomab-B, is currently being studied in a pivotal Phase 3 trial as a myeloablative conditioning agent prior to a bone marrow transplant. Recently, Actinium announced that it had amended the protocol of its pivotal Phase 3 SIERRA trial to expand the number of salvage chemotherapy agents included in the control arm. The response from clinical trial principal investigators to this change has been positive. In addition, Actinium recently announced that it had activated Stony Brook University as the 16th clinical trial site in the SIERRA trial.

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Dr. Mark Berger, Chief Medical Officer of Actinium said, "As we have made significant progress with the SIERRA trial, we recognized that the regimens in the control arm needed to be expanded, based largely on feedback from our investigators and advisory board. We believe that investigators recognized the imbalance between groups, evidenced by the crossover component of the trial, so we were eager to make these changes, which have been very well received by trial investigator. As a result, we believe physicians have a more receptive view to the control arm that will lead to accelerated rates of enrollment. Once again, the BMT Tandem Meetings have proved to be an invaluable conference for us and we look forward to capitalizing on the positive momentum we generated in our interactions with the transplant community to complete enrollment of the SIERRA trial."

In addition, Dr. Sergio Giralt, Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center and Dr. Koen van Besien, Director, Stem Cell Transplant Program at Weill Cornell Medical Center highlighted trials from the Company’s CD33 program in the Company’s well attended product theater. Dr. Giralt highlighted the myeloablative potential of Actinium’s CD33 prior to a bone marrow transplant for patients with multiple myeloma that is being studied in the Actimab-M Phase 1 trial. Currently, Actimab-M is the only trial for a CD33 targeting agent and alpha-particle based therapy for multiple myeloma. Dr. van Besien also highlighted the myeloablative potential in patients with high-risk myelodysplastic syndrome (MDS) with a p53 genetic mutation that is expected to be studied in a planned Phase 2 trial for Actimab-MDS. The Actimab-MDS trial will be conducted with the MDS Clinical Research Consortium and this trial will be led by Dr. Gail Roboz, Director of the Leukemia Program and Professor of Medicine at Weill Cornell New-York Presbyterian Hospital and her colleagues at the Cleveland Clinic, Dana-Farber Cancer Institute, Johns Hopkins, MD Andersen Cancer Center, Moffitt Cancer Center and Weill Cornell.

Sandesh Seth, Actinium’s Executive Chairman said, "We were incredibly excited for Tandem this year as we were able to showcase our multi-disease, multi-target pipeline focused on myeloablation for the first time at this conference. There are great advances being made in the field of bone marrow transplant and we are excited to be at the forefront of improved myeloablation, which is a critical aspect of the patient’s journey and where we can make significant impact to patient access and outcomes. We came away from the conference incredibly excited by the opportunities that we see emerging in transplant and cell therapies that our technologies and growing pipeline are ideally suited for and also the opportunity to be the market leader providing superior conditioning in this growing area."

About BMT Tandem Meetings

Annually, the BMT Tandem Meetings are the largest gathering in North America of worldwide experts in blood and marrow transplant patient care, clinical investigation and laboratory research. Over 3,000 transplant physicians in over 500 transplant centers from >50 countries participate in the CIBMTR. The ASBMT has a membership of over 2,300 clinicians and researchers. By combining our meetings, we expect over 3,200 participants at next year’s meetings representing more than 50 countries, with approximately 20% coming from outside the United States.

On February 28, 2018 Galera Therapeutics, Inc., a clinical-stage biotechnology company developing drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, reported the first patient with locally advanced pancreatic cancer (LAPC) has been dosed in a Phase 1/2 clinical trial of lead candidate GC4419, a highly selective and potent small molecule dismutase mimetic, at The University of Texas MD Anderson Cancer Center in Houston, Texas (Press release, Galera Therapeutics, FEB 28, 2018, View Source [SID1234524232]).

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Pancreatic cancer is the fourth-leading cause of cancer-related death in the United States, with more than 55,000 patients diagnosed annually. Although its five-year overall survival rate is approximately less than 5 percent, it has the potential to improve to more than 25 percent following successful surgical resection, according to the American Cancer Society. Unfortunately, fewer than 10 percent of patients have resectable tumors at diagnosis. A goal of treatment for patients with LAPC is to use a combination of aggressive chemotherapy and radiation to shrink the unresectable tumor and improve the possibility of resectability.

Preclinical data demonstrate GC4419 has the potential to improve the effectiveness of radiation on cancer cells while preventing toxicity in normal tissue. GC4419 leverages Galera’s dismutase mimetic platform to rapidly convert the superoxide generated by radiation therapy into hydrogen peroxide, which is lethal to cancer cells in high concentrations. The most profound effects are seen when combining GC4419 with targeted, high doses of radiation like that used in stereotactic body radiation therapy (SBRT). This is because the amount of hydrogen peroxide created by the conversion of superoxide increases as the dose of radiation increases when combined with GC4419, producing a magnified anti-tumor effect.

"Our recently completed 223-patient Phase 2b trial of GC4419 in head and neck cancer demonstrated GC4419’s ability to limit radiation-induced healthy tissue damage by reducing the duration, incidence and severity of radiation and chemotherapy-induced oral mucositis," said Mel Sorensen, M.D., President and CEO of Galera. "We seek to build upon these results with this anti-tumor trial in LAPC and generate robust data to demonstrate GC4419’s potential to change the management of radiation therapy by both protecting normal tissue and improving the effectiveness of radiation, making more surgical resections possible."

The adaptive, Phase 1/2 dose escalation trial will evaluate the safety and anti-tumor effect (i.e. tumor response and improvement in resectability) of GC4419 in combination with SBRT, compared with SBRT alone, in LAPC patients. The trial, which will enroll 48 patients, will also assess safety and tolerability to determine the maximum tolerated dose of SBRT when combined with GC4419 or placebo.

"GC4419 offers the potential to create two opportunities to improve radiation therapy – by synergistic anti-tumor efficacy and by protecting healthy cells at higher doses of radiation," said Jon T. Holmlund, M.D., Chief Medical Officer of Galera. "This trial will indicate whether SBRT and GC4419 can offer a powerful combination therapy that may improve the survival for LAPC patients by making inoperable tumors operable, which may have important implications for the treatment of pancreatic and other cancers."

About GC4419

GC4419 is a highly selective and potent small molecule dismutase mimetic that closely mimics the activity of human superoxide dismutase enzymes. GC4419 works to reduce elevated levels of superoxide caused by radiation therapy by rapidly converting superoxide to hydrogen peroxide and oxygen. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy. Conversion of elevated superoxide to hydrogen peroxide, which is selectively more toxic to cancer cells, can also enhance the effect of radiation on tumors, particularly with stereotactic body radiation therapy (SBRT), which produces high levels of superoxide.

GC4419 has been studied in patients with head and neck cancer, GC4419’s lead indication, for its ability to reduce the duration, incidence and severity of radiation-induced severe oral mucositis (SOM). Results from Galera’s 223-patient, double blind, randomized, placebo-controlled Phase 2b clinical trial demonstrated GC4419’s ability to dramatically reduce the duration of SOM from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients’ OM by 47 percent, while demonstrating acceptable safety when added to a standard radiotherapy regimen. In addition, in multiple preclinical studies, GC4419 demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiation therapy with or without systemic therapy. The FDA also granted Fast Track designation to GC4419 for the reduction of the severity and incidence of radiation and chemotherapy-induced OM.

Pacira Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Pacira Pharmaceuticals, 2018, FEB 28, 2018, View Source [SID1234524217]).

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On February 28, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported financial results for the fourth quarter and full year of 2017 and its outlook for 2018 (Press release, Pacira Pharmaceuticals, FEB 28, 2018, View Source;p=RssLanding&cat=news&id=2335267 [SID1234524254]).

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"2017 was a year of solid progress and set the stage for an important year ahead," said Dave Stack, chairman and chief executive officer of Pacira. "EXPAREL has now been used in over 3.5 million patients across the United States and continues to grow. We remain steadfast in our mission to provide a non-opioid option to as many patients as possible, including defining the next steps for the expanded nerve block indication through our pending sNDA. Our strategic partnership with Johnson & Johnson continues to drive EXPAREL use within the orthopedic setting. In addition, we are advancing key collaborations to support best-practice opioid minimization strategies. Finally, our education and awareness campaigns are bearing fruit as more and more key stakeholders including patients, physicians, medical societies and advocacy organizations are recognizing and appreciating the benefits of non-opioid postsurgical pain control."

Highlights and Recent Events

Collaboration with The University of Tennessee Medical Center and CQ-Insights to minimize opioid use after hernia surgery. In February 2018, The University of Tennessee Medical Center and Pacira announced a continuous quality improvement (CQI) project designed to develop low-or no-opioid postsurgical pain management pathways for patients undergoing one of the most common surgical procedures, hernia surgery.

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee did not support approval of the EXPAREL sNDA for nerve block. In February 2018, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee’s (AADPAC) reviewed the company’s supplemental New Drug Application, or sNDA, seeking expansion of the EXPAREL label to include administration via nerve block for prolonged regional analgesia. The AADPAC voted six to four against approval of the expanded indication. The committee’s feedback will be considered for the FDA in its review of the sNDA. The FDA’s Prescription Drug User Fee Act goal date for completion of its review is April 6, 2018.

Partnership with WellStar Health Systems to minimize opioid use and standardize outcomes across surgical procedures. In January 2018, WellStar Health System, the largest health system in Georgia, and Pacira announced a joint commitment to address opioid use and dependence following surgery. Through a comprehensive opioid minimization strategy, the organizations will work together to educate hospital clinicians and administrators about the burden of postsurgical opioids; develop enhanced recovery protocols to reduce use in key surgical procedures; and standardize the rollout of these protocols across WellStar’s 11 hospitals.

Promotions of Scott Braunstein, MD, to Chief Operating Officer and Richard Scranton, MD, to Chief Scientific Officer. In December 2017, Scott Braunstein, MD, was named Chief Operating Officer and Richard Scranton, MD, was named Chief Scientific Officer. Dr. Braunstein is overseeing the company’s commercial and medical affairs functions while continuing to manage strategy and corporate development. As Chief Scientific Officer, Dr. Scranton is directing the company’s clinical research while continuing to lead scientific communications, market access, and health outcomes research and analytics for EXPAREL.

Collaboration with Illinois Surgical Quality Improvement Collaborative to minimize opioid exposure for postsurgical patients. In December 2017, the Illinois Surgical Quality Improvement Collaborative, a nationally recognized partnership of 56 Illinois hospitals, and Pacira announced an initiative to jointly develop programs and resources that will support best practice pain management prescribing for surgical patients throughout the state of Illinois. The focus of the initiative is to develop and provide intensive, interactive educational tools for hospitals in order to improve adherence to evidence-based best practices for perioperative pain management.

Collaboration with Cancer Treatment Centers of America to educate physicians and patients about responsible opioid use. In November 2017, Cancer Treatment Centers of America, a national network of five hospitals and Pacira announced a new collaboration dedicated to reducing the risk of opioid dependence among cancer patients. The goal of the Opioid Risk Reduction Initiative—an education effort focused on responsible use and increased awareness of opioid alternatives—is to improve the cancer patient experience through expanded pain management options.

Fourth Quarter 2017 Financial Results

EXPAREL net product sales were $78.7 million in the fourth quarter of 2017, a 10% increase over the $71.4 million reported for the fourth quarter of 2016.

Total revenues were $79.1 million in the fourth quarter of 2017, an 8% increase over the $72.9 million reported for the fourth quarter of 2016.

Total operating expenses were $70.6 million in the fourth quarter of 2017, compared to $75.4 million in the fourth quarter of 2016.

GAAP net income was $4.6 million, or $0.11 per share (basic and diluted), in the fourth quarter of 2017, compared to a GAAP net loss of $4.0 million, or $0.11 per share (basic and diluted), in the fourth quarter of 2016.

Non-GAAP net income was $16.0 million, or $0.39 per share (basic) and $0.38 per share (diluted), in the fourth quarter of 2017, compared to non-GAAP net income of $3.6 million, or $0.10 per share (basic) and $0.09 per share (diluted), in the fourth quarter of 2016.

Pacira had 40.6 million basic weighted average shares of common stock outstanding in the fourth quarter of 2017.

Pacira had 41.6 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2017.

Full-Year 2017 Financial Results

EXPAREL net product sales were $282.9 million in 2017, a 6% increase over the $265.8 million reported in 2016.

Total revenues were $286.6 million in 2017, a 4% increase over the $276.4 million reported in 2016.

Total operating expenses were $311.6 million in 2017, compared to $308.4 million in 2016.

GAAP net loss was $42.6 million, or $1.07 per share (basic and diluted) in 2017, compared to a GAAP net loss of $37.9 million, or $1.02 per share (basic and diluted) in 2016.

Non-GAAP net income was $8.6 million, or $0.22 per share (basic) and $0.21 per share (diluted), in 2017, compared to non-GAAP net income of $25.2 million, or $0.68 per share (basic) and $0.62 per share (diluted), in 2016.

Pacira ended 2017 with cash, cash equivalents, short-term and long-term investments ("cash") of $371.4 million.

Pacira had 39.8 million basic weighted average shares of common stock outstanding in 2017.

For non-GAAP measures, Pacira had 41.4 million diluted weighted average shares of common stock outstanding in 2017.

2018 Outlook

Pacira announces its full year 2018 financial guidance as follows. Pacira expects:

EXPAREL net product sales of $300 million to $310 million.

Non-GAAP gross margins of 70% to 72%.

Non-GAAP research and development (R&D) expense of $50 million to $60 million.

Non-GAAP selling, general and administrative (SG&A) expense of $150 million to $160 million.

Stock-based compensation of $30 million to $35 million.

See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2018 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, February 28, 2018, 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 5198726.

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 5198726. 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, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense, 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 expense and SG&A expense outlook for 2018 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 2018 financial guidance for gross margins, R&D expense and SG&A expense.

On February 28, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company focused on identifying, developing, and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology, reported that it will report financial results for the fourth quarter and year ending December 31, 2017 on Monday, March 12, 2018, before the U.S. financial markets open (Press release, Aclaris Therapeutics, FEB 28, 2018, https://aclaristherapeuticsinc.gcs-web.com/news-releases/news-release-details/aclaris-therapeutics-webcast-conference-call-discussing-fourth [SID1234524219]).

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Management will provide an update on the Company and discuss fourth quarter and year-end 2017 results as well as expectations for the future via conference call on Monday, March 12, 2018, at 8:00 AM ET. To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 1495576 prior to the start of the call.

A live webcast of the event can be accessed on the Events and Presentations page on the Investors section of the Aclaris website at View Source A replay of the webcast will be archived on the Aclaris website following the event.