On February 12, 2019 Diplomat Pharmacy, Inc. (NYSE: DPLO) executives reported that it will participate in four upcoming investor conferences (Press release, Diplomat Speciality Pharmacy, FEB 12, 2019, View Source [SID1234533256]).

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Brian Griffin, chairman and CEO, and Atul Kavthekar, chief financial officer, will represent the company at these events:

8th Annual SVB Leerink Global Healthcare Conference in New York: Feb. 27 at 9 a.m. ET
Raymond James 40th Annual Institutional Investors Conference in Orlando: March 4 at 4 p.m. ET
Cowen and Company 39th Annual Health Care Conference in Boston: March 11 at 1:30 p.m. ET
Barclays Global Healthcare Conference in Miami: March 14 at 8:30 a.m. ET

Live audio webcasts of each presentation will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. Audio recordings will be available online for approximately 30 days following each presentation.

On February 12, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that a presentation of data from the pivotal Phase 3 SIERRA trial of Iomab-B has been selected as one of four late breaking oral presentations at the 2019 TCT or Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR, which is being held February 20 – 24 in Houston, Texas (Press release, Actinium Pharmaceuticals, FEB 12, 2019, View Source [SID1234533255]). In addition, three abstracts related to Actinium’s targeted conditioning pipeline have been accepted for poster presentations.

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Sandesh Seth, Chairman and CEO of Actinium, said, "TCT is the ideal venue for us to present data and highlight our targeted conditioning programs as it is the pre-eminent medical meeting focused on bone marrow transplant and cellular therapy. We are excited to have multiple opportunities to highlight clinical data for Iomab-as well as update on Iomab-ACT, our newest program focused on lymphodepletion prior to CAR-T. In addition, we are involved with several events, educational and otherwise, that will enable us to educate a broad audience of investigators, researchers and potential partners about the SIERRA trial and our highly differentiated multi-disease, multi-target targeted conditioning pipeline. We expect this meeting to be a highly productive and consequential one for our company."

Highlights of Actinium’s key meeting activities are:

Late Breaking Oral Presentation

Title:

Novel Re-Induction and Anti-CD45 Targeted Conditioning with Iodine (131I) Apamistamab [Iomab-B] Yields Encouraging Results in Older Patients with Active, Relapsed or Refractory AML: Safety & Feasibility Data from the Prospective Randomized Phase III SIERRA Trial

Presenter:

Sergio Giralt, MD, Chief Attending Physician, Adult Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer Center

Time:

Sunday, February 24th, 12:30-12:45 PM CT

Location:

Hilton Americas – Grand Ballroom A

Poster Presentations

Poster Title:

Lymphodepletion with CD45 Radioimmunotherapy as a Targeted Conditioning Regimen Prior to Adoptive Cell Therapy or CAR-T

Presenter:

Dale Ludwig, PhD, Chief Scientific Officer, Actinium Pharmaceuticals, Inc.

Time:

Wednesday, February 20th, 6:45 – 7:45 PM CT

Location:

George R. Brown Convention Center – GRB Exhibit Hall B3

Poster Title:

Survival of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Patients Receiving Stem Cell Transplantation (SCT)

Presenter:

Rajneesh Nath, MD, Director Bone Marrow Transplant & Acute Leukemia Program, Banner MD Anderson Cancer Center

Time:

Wednesday, February 20th, 6:45 – 7:45 PM CT

Location:

George R. Brown Convention Center – GRB Exhibit Hall B3

Poster Title:

Burden of Hospitalization in Allogeneic Stem-Cell Transplantation for Acute Myeloid Leukemia

Presenter:

Vijay Reddy, MD, PhD, Vice President, Clinical Development and Head of Bone Marrow Transplant, Actinium Pharmaceuticals, Inc.

Time:

Wednesday, February 20th, 6:45 – 7:45 PM CT

Location:

George R. Brown Convention Center – GRB Exhibit Hall B3

TCT 2019 Satellite Symposium

Satellite symposia are attended by nearly 2,000 physicians, scientists and allied health professionals working in blood and marrow transplantation in BMT programs throughout the United States, Canada and over 30 other countries.

Title:

Integrating Innovative Therapeutics with Allogeneic HSCT in AML: Insights and Evidence from Induction to Maintenance

Presenters:

James Foran, MD, Associate Professor of Medicine, Mayo Clinic and Alexander Perl, MD, Associate Professor of Medicine, University of Pennsylvania

Time:

Saturday, February 23rd, 12:30 – 1:30 PM

Location:

George R. Brown Convention Center, Grand Ballroom ABC

Dr. Mark Berger, Chief Medical Officer of Actinium commented, "TCT brings together the close-knit community of BMT and CAR-T physicians and health professionals resulting in an incredibly productive and valuable meeting. We are honored to have the opportunity to share so much of our research and clinical programs with the meeting attendees this year. Given the recent promising data presented at ASH (Free ASH Whitepaper) for Iomab-B, our late breaking oral presentation for Iomab-B and the recent launch of our Iomab-ACT program for CAR-T, I expect this year to be our most productive and rewarding conference yet."

About Transplantation & Cellular Therapy Meetings (TCT)
TCT, formerly known as the BMT Tandem Meetings, are the combined annual meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). Each year the conference brings together several thousand investigators, clinicians, researchers, nurses and other allied health professionals from over 500 transplant centers from over 50 countries around a full scientific program focused on bone marrow transplant and cellular therapies.

On February 12, 2019 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the second quarter ended December 31, 2018 (Press release, DelMar Pharmaceuticals, FEB 12, 2019, View Source [SID1234533254]). DelMar executive management will host a business update conference call for investors, analysts and other interested parties on February 19, 2019 at 4:30 p.m. Eastern Time.

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"During the second quarter, we continued enrollment in our Phase 2 clinical trials for MGMT-unmethylated GBM patients at the MD Anderson Cancer Center in Houston, Texas, and at Sun Yat-sen University Cancer Center in Guangzhou, China," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar Pharmaceuticals. "We are now nearing full enrollment at MD Anderson and halfway enrollment in China. We are eagerly anticipating data from each of these studies."

RECENT HIGHLIGHTS

Continued enrolling patients in Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent glioblastoma multiforme ("GBM") study being conducted at the MD Anderson Cancer Center (the "MDACC study").
As of January 31, 2019, forty-six patients have been enrolled in the MDACC study
The dosing levels used in the MDACC study have continued to demonstrate a safety profile well within the existing safety monitoring guidelines described in the present study protocol
Similar to prior clinical experience, myelosuppression has been the most common adverse event observed
Continued enrolling patients in Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated GBM study at Sun Yat-sen University Cancer Center.
As of January 31, 2019, fourteen patients have been enrolled in this study
Observed increased enrollment rates in the recent quarter
On February 4, 2019, the Company received a written notice that The Nasdaq Capital Market LLC (Nasdaq) had granted the Company an extension until June 25, 2019 to regain compliance with the Minimum Bid Price requirement. During the extension, the Company must remain in compliance with all other listing requirements of Nasdaq.
Based on overall clinical and corporate development progress achieved to date, DelMar expects to have cash available to fund planned operations into the middle of calendar 2019.
For further details on the Company’s operating and financial results, as well as more detail about its updated strategy, refer to DelMar’s Form 10-K filed with the SEC on September 24, 2018, as well as the Company’s Quarterly Report on Form 10-Q for the three and six months ended December 31, 2018 filed with the SEC on February 11, 2019:

View Source

CONFERENCE CALL DETAILS

DelMar will host a conference call to discuss its financial results for quarter ended December 31, 2018 and provide a corporate update on February 19, 2019, at 4:30 p.m. Eastern Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 1-877‑876‑9174 (toll free) with Conference ID DELMAR.

A replay of the conference call will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR PERIODS ENDED DECEMBER 31, 2018

At December 31, 2018, the Company had cash and cash equivalents on hand of approximately $3.7 million.

For the three months ended December 31, 2018, the Company reported a net loss of $1,809,697, or $0.08 per share, compared to a net loss of $3,161,598, or $0.14 per share, for the three months ended December 31, 2017.

For the six months ended December 31, 2018, the Company reported a net loss of $3,801,501, or $0.16 per share, compared to a net loss of $5,828,004, or $0.31 per share, for the six months ended December 31, 2017.

The following represents selected financial information as of December 31, 2018. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and management’s discussion and analysis, as filed.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company’s website at: View Source

Research and development expenses decreased to $947,249 during the three months ended December 31, 2018 from $2,141,945 for the three months ended December 31, 2017. The decrease was largely attributable to a decrease in clinical development costs, personnel, preclinical research, and non-cash, share-based compensation expense during the three months ended December 31, 2018 compared to the three months ended December 31, 2017.

General and administrative expenses decreased during the three months ended December 31, 2018 to $874,884 from $1,011,879 for the three months ended December 31, 2017, largely due to a decrease in professional fees and personnel, partially offset by higher non-cash, share-based compensation expense in the current quarter compared to the prior quarter.

Research and development expenses decreased to $1,966,369 during the six months ended December 31, 2018 from $4,076,588 for the six months ended December 31, 2017. The decrease was largely attributable to a decrease in clinical development costs, personnel, preclinical research, intellectual property and travel costs during the current period compared to the prior period.

General and administrative expenses were $1,861,354 for the six months ended December 31, 2018 compared to $1,756,500 for the six months ended December 31, 2017. A significant portion of the increase was due to an increase in non-cash, share-based compensation expense and personnel costs in the current period compared to the prior period. Partially offsetting the impact of these two items were lower professional fees and travel costs during the six months ended December 31, 2018 compared to the six months ended December 31, 2017.

On February 12, 2019 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report financial results for the fourth quarter and full year of 2018 after 5:00 p.m. ET on Tuesday, February 26, 2019 (Press release, Supernus, FEB 12, 2019, View Source [SID1234533252]).

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Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Chief Financial Officer, will host a conference call to present the fourth quarter and full year 2018 business results on Wednesday, February 27, 2019 at 9:00 a.m. ET. Following management’s prepared analysis and discussion of business results, the call will be open for questions.

A live webcast will be available at www.supernus.com.

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: (877) 288-1043
International dial-in: (970) 315-0267
Conference ID: 2170478
Conference Call Name: Supernus Pharmaceuticals Fourth Quarter and Full Year 2018 Earnings Conference Call
Following the live call, a replay will be available on the Company’s website under the ‘Investors’ section. The webcast will be available on the Company’s website for 60 days following the live call.

On February 12, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the U.S. Food and Drug Administration (U.S. FDA) has approved a split dosing regimen for DARZALEX (daratumumab) (Press release, Genmab, FEB 12, 2019, View Source [SID1234533251]). The approval will be included in an update to the Prescribing Information in order to provide healthcare professionals the option to split the first infusion of DARZALEX over two consecutive days. The supplemental Biologics License Application (sBLA) was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., in July, 2018. The split dosing option was previously approved in Europe by the European Commission in December 2018. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"We are pleased that, with this change, patients in the U.S. receiving their first infusion of DARZALEX may now have this more flexible dosing option," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab

This approval was supported by data from the Phase Ib EQUULEUS (MMY1001) clinical trial, which demonstrated DARZALEX pharmacokinetics (PK) concentrations were comparable regardless of whether the first dose was administered as a split infusion or as a single first infusion in patients with multiple myeloma. The safety profile of DARZALEX was comparable when administered initially as either a split or a single dose.

About the EQUULEUS (MMY1001) Study
The Phase Ib EQUULEUS open-label study includes up to 240 patients with the goal of evaluating the safety, tolerability and dose of daratumumab when administered in combination with various backbone treatment regimens for different settings of multiple myeloma.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma, B and T-ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.