On August 2, 2018 Medivir AB (Nasdaq Stockholm: MVIR) reported that the first patient has been enrolled and is being dosed with remetinostat gel 1% in an investigator-initiated phase II clinical study in patients with basal cell carcinoma (BCC) (Press release, Medivir, AUG 2, 2018, View Source [SID1234528308]). This clinical study will be conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr Kavita Sarin. Medivir will be providing remetinostat drug supply for this study, and will have full access to, and the rights to use, all clinical data after the study is complete.

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The primary objective of the study is to assess the effects of topical remetinostat on the overall response rate in a cohort of BCC patients and could establish that remetinostat has the potential for use in other skin-associated cancers in addition to CTCL. Further details of the study can be found at www.clinicaltrials.gov with the reference NCT03180528.

"This study highlights the potential of remetinostat to be used in conditions beyond early-stage cutaneous T-cell lymphoma," said Christine Lind, CEO of Medivir. She continues, "We look forward to the completion of the study and communication of the clinical outcomes."

For further information, please contact:
Christine Lind, CEO, Medivir AB, phone: +46 (0)8 5468 3100
Erik Björk, CFO, Medivir AB, mobile: +46 (0)72 228 2831

About remetinostat
Remetinostat is a histone deacetylase (HDAC) inhibitor. The unique design of remetinostat enables topical application, making it active only in the skin. As soon as it reaches the blood stream, it is degraded, avoiding the side effects associated with other HDAC inhibitors.

On August 2, 2018 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that it will release second quarter 2018 financial results on Wednesday, August 8, 2018 after the U.S. financial markets close. Celldex executives will host a conference call at 4:30 p.m. EDT on the same day to review the second quarter 2018 financial results and to provide an update on key research and development and business objectives for the remainder of 2018.

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The conference call and presentation will be webcast live over the Internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 4768019.

A replay of the call will be available approximately two hours after the live call concludes through August 15, 2018. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 4768019. The webcast will also be archived on the Company’s website.

On August 2, 2018 Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that William G. Rice, Chairman, Ph.D., President and Chief Executive Officer, and Gregory K. Chow, Senior Vice President and Chief Financial Officer, will participate at the Canaccord Genuity 38th Annual Growth Conference being held from Wednesday, August 8th to Thursday, August 9th, 2018, at the Intercontinental Hotel, Boston, MA (Press release, Aptose Biosciences, AUG 2, 2018, View Source;p=RssLanding&cat=news&id=2361651 [SID1234528373]).

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Dr. Rice will provide a corporate overview of the Company’s recent activities and strategic direction.

Time: 12:30 p.m. ET
Date: Thursday, August 9, 2018
Location: Intercontinental Hotel, Boston, MA
A live webcast of the Aptose presentation will be accessible by visiting:

View Source

The webcast will be archived shortly after the live event and will be available for 90 days through the Aptose website at www.aptose.com

On August 2, 2018 Evelo Biosciences, Inc. (Nasdaq:EVLO) (Evelo), a clinical stage biotechnology company developing monoclonal microbials designed to act on the gut-body network for the treatment of a wide range of diseases, reported financial results and provided a business update for the second quarter ended June 30, 2018 (Press release, Evelo Biosciences, AUG 2, 2018, View Source [SID1234528391]).

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"Our recent accomplishments represent important progress across our business, as we entered the clinic with our first monoclonal microbial, EDP1066, and continued to advance our broad portfolio of preclinical product candidates in a range of inflammatory and oncology indications," said Simba Gill, Ph.D., President and Chief Executive Officer of Evelo. "Looking to the second half of 2018, we are focused on advancing EDP1815 and EDP1503 into their first clinical trials in inflammatory disease and oncology, respectively, as we seek to advance our diversified portfolio of monoclonal microbials toward ten potential clinical readouts between 2019 and 2020 across different diseases and underlying biologies. We are also committed to further understanding of the gut-body network more broadly, as highlighted by our recently-signed research collaboration with world-leaders at Harvard University, which will enable us to further explore the gut’s role in modulating immune activity throughout the body."

Second Quarter and Recent Business Highlights:

Pipeline:

In May 2018, the U.S. Food and Drug Administration accepted an Investigational New Drug application to begin a 70-patient open-label Phase 2 clinical trial of EDP1503, a monoclonal microbial for the treatment of cancer. The University of Chicago will conduct this investigator-sponsored open-label clinical trial, which is designed to evaluate the safety, tolerability, and efficacy of EDP1503 in combination with a checkpoint inhibitor in patients with metastatic melanoma.
In April 2018, Evelo dosed the first subject in its 96-subject Phase 1 clinical trial of EDP1066, a monoclonal microbial for the treatment of inflammatory diseases. This clinical trial is designed to evaluate the safety and tolerability of a range of daily doses of EDP1066 in healthy volunteers and in patients with psoriasis and atopic dermatitis. Additional exploratory endpoints include the effect of EDP1066 on validated clinical measures of disease and on an integrated set of biomarkers.
Harvard University Research Collaboration:

In June 2018, Evelo entered into a research collaboration with scientists at Harvard University to study the gut-body network. Evelo will work with three of the world’s leading experts in immunology and microbiology at Harvard Medical School: Diane Mathis, Ph.D., the Morton Grove-Rasmussen Professor of Microbiology and Immunobiology, Christophe Benoist, M.D., Ph.D., the Morton Grove-Rasmussen Professor of Immunohematology, and Dennis Kasper, M.D., the William Ellery Channing Professor of Medicine and Professor of Microbiology and Immunobiology. The collaboration aims to further elucidate the mechanisms by which microbes acting on cells in the gut have the potential to treat disease elsewhere in the body. Under the multi-year agreement, Evelo has an exclusive option to license from Harvard intellectual property rights that may arise from this research collaboration.
Corporate:

In June 2018, Evelo was added to the Russell 3000, Russell 2000 and Russell Microcap Indexes as part of the Russell Investments’ annual reconstitution.
In May 2018, Evelo completed its initial public offering of common stock at $16.00 per share, raising $75.8 million in net proceeds after deducting underwriting discounts and commissions and other offering expenses.
Upcoming Anticipated Milestones:

Initiation of the University of Chicago’s investigator-sponsored, open-label Phase 2 clinical trial of EDP1503 in combination with a PD-1 inhibitor in patients with metastatic melanoma expected in the second half of 2018.
Initiation of a Phase 1 clinical trial of EDP1815, an anti-inflammatory monoclonal microbial product candidate, in patients with psoriasis and atopic dermatitis in the fourth quarter of 2018.
Initiation of a Phase 2 clinical trial of EDP1503 in combination with a checkpoint inhibitor in patients with multiple cancer types in the first half of 2019.
Initial clinical data from ongoing Phase 1 clinical trial of EDP1066 in patients with psoriasis and atopic dermatitis in the first half of 2019.
Second Quarter 2018 Financial Results:

Cash Position: As of June 30, 2018, cash and cash equivalents were $178.9 million, as compared to cash and cash equivalents of $38.2 million as of December 31, 2017. This increase was due to net proceeds of $81.3 million from the issuance of Series C Preferred Stock, net proceeds of $75.8 million from Evelo’s initial public offering and $5.0 million of additional drawings from Evelo’s existing debt facility, partially offset by cash used to fund operating activities for the first half of 2018. Evelo expects that its cash and cash equivalents will enable it to fund its planned operating expenses and capital expenditure requirements into the second half of 2020.
Research and Development Expenses: R&D expenses were $10.2 million for the three months ended June 30, 2018, compared to $4.7 million for the three months ended June 30, 2017. The increase of $5.5 million was due primarily to increases in costs related to Evelo’s inflammation and gut-body network platform expenses as well as increased personnel costs.
General and Administrative Expenses: G&A expenses were $5.1 million for the three months ended June 30, 2018, compared to $1.5 million for the three months ended June 30, 2017. The increase of $3.6 million was due primarily to increased general and administrative personnel costs, professional and consulting fees, and facility expenses supporting Evelo’s growing organization and public company infrastructure.
Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $16.7 million for the three months ended June 30, 2018, or $0.85 per basic and diluted share, as compared to a net loss attributable to common stockholders of $7.8 million for the three months ended June 30, 2017, or $2.09 per basic and diluted share.

On August 2, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative therapeutics for the treatment of cancer, reported its financial results for the second quarter ended June 30, 2018 (Press release, Curis, AUG 2, 2018, View Source [SID1234528309]).

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"Our second quarter has been marked by continued progress in advancing our three clinical drug candidates further in their respective development," said Ali Fattaey, Ph.D., Chief Executive Officer of Curis. "We continue to assess and hold productive discussions with the FDA to identify a path to register fimepinostat, which could provide much-needed benefit for patients with R/R DLBCL, and in particular those whose disease have MYC alterations. CA-170, our orally available small-molecule checkpoint inhibitor, continues to progress in Phase 1 and Phase 2 clinical studies with a planned update in the second half of 2018. Patient enrollment continues for our recently initiated Phase 1 study of precision oncology candidate CA-4948, currently the only IRAK4 kinase inhibitor in clinical development for cancer. In addition, we recently welcomed Dr. Robert Martell into his new role as Head of Research and Development. Dr. Martell is a practicing oncologist whose extensive experience in drug development will help strengthen Curis’s oncology portfolio. We believe Curis remains on track to advancing multiple attractive candidates with potential to substantially impact current oncology care."

Second Quarter 2018 Financial Results

Curis reported a net loss of $8.7 million, or $0.26 per share on both a basic and diluted basis for the second quarter of 2018, as compared to a net loss of $14.1 million, or $0.49 per share on both a basic and diluted basis for the same period in 2017. Curis reported a net loss of $19.4 million, or $0.59 per share, on both a basic and diluted basis for the six months ended June 30, 2018, as compared to a net loss of $29.8 million, or $1.04 per share on both a basic and diluted basis for the same period in 2017.

Revenues for the second quarter of 2018 were $2.4 million, as compared to $2.1 million for the same period in 2017. Revenues for the six months ended June 30, 2018 were $4.8 million, as compared to $4.2 million for the same period in 2017. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses were $10.2 million for the second quarter of 2018, as compared to $15.2 million for the same period in 2017. Operating expenses for the six months ended June 30, 2018 were $22.6 million, as compared to $32.4 million for the same period in 2017, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, resulting from payments to third-party university patent licensors associated with Genentech and Roche’s Erivedge net sales, were $0.1 million for both the second quarter of 2018 and 2017. Cost of royalty revenues for the six months ended June 30, 2018 were $0.3 million, as compared to $0.2 million for the same period in 2017.

Research and Development Expenses. Research and development expenses were $6.5 million for the second quarter of 2018, as compared to $11.3 million for the same period in 2017. The decrease was primarily driven by decreased costs related to clinical activities for fimepinostat and CA-170, partially offset by increased costs related to CA-4948. Research and development expenses were $14.7 million for the six months ended June 30, 2018 as compared to $24.8 million for the same period in 2017.

General and Administrative Expenses. General and administrative expenses were $3.6 million for the second quarter of 2018 as compared to $3.8 million for the same period in 2017. The decrease in general and administrative expenses was primarily driven by lower personnel and stock-based compensation expense partially offset by higher legal services for the period. General and administrative expenses were $7.6 million for the six months ended June 30, 2018, as compared to $7.4 million for the same period in 2017.

Other Expenses. Net other expense for the second quarter 2018 totaled $0.8 million as compared to $1.0 million for the same period in 2017. Net other expense primarily consisted of interest expense related to Curis Royalty’s (a wholly owned subsidiary of Curis) debt obligations. Other expense, net was $1.6 million and $1.7 million for the six months ended June 30, 2018 and 2017, respectively.

As of June 30, 2018, Curis’s cash, cash equivalents, marketable securities and investments totaled $40.4 million and there were approximately 33.2 million shares of common stock outstanding.

Recent Operational Highlights

Precision oncology, fimepinostat (formerly CUDC-907):

Fimepinostat received Fast Track designation from the FDA for development in adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy.
Immuno-oncology, CA-170 (PDL1 / VISTA antagonist; Aurigene collaboration):

Patient enrollment remained on track for the Phase 1 dose escalation trial evaluating CA-170 in patients with advanced solid tumors or lymphomas.
Curis collaborator Aurigene continued to enroll patients in a Phase 2 clinical study of CA-170 at select trial sites in India.
Investigators have recently identified that mesothelioma tumor samples express high levels of VISTA immune checkpoint protein. We are extending our current Phase 1 trial to enroll a cohort of patients with mesothelioma.
Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene collaboration):

Curis continued to enroll patients with relapsed or refractory non-Hodgkin lymphoma in a Phase 1 clinical trial evaluating CA-4948, a novel oral, small molecule IRAK4 kinase Inhibitor that has shown potent in vivo anti-tumor activity in preclinical animal models.
We have recently generated non-clinical data that demonstrate CA-4948 is active in in vivo models of AML. We are extending our current Phase 1 clinical trial to enroll a cohort of patients with AML.
Recent Corporate Highlights

Robert Martell, M.D., Ph.D., a practicing oncologist and experienced drug developer, was appointed Head of Research and Development and will directly manage the day-to-day operations of clinical development and research.
Curis announced a 1-for-5 reverse stock split reducing the number of Curis’s outstanding common stock from approximately 165.6 million to approximately 33.1 million on March 29, 2018, the date of the reverse split.
Upcoming Activities

Curis anticipates providing an outline of the clinical development path for fimepinostat in 2H 2018.
Curis and collaborator Aurigene expect to provide additional updates in 2H 2018 on the clinical progress of CA-170, which is currently being evaluated in one Phase 1 and one Phase 2 study.
Curis expects to provide an update in 2H 2018 on the progress of CA-4948, which is currently being evaluated in a Phase 1 trial in patients with advanced lymphomas.
Conference Call Information

Curis management will host a conference call today, August 2, 2018, at 8:30 a.m. EDT, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 (United States) or 1-412-317-5252 (International), shortly before 8:30 a.m. EDT. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section. A replay of the call will be available on the Curis website shortly after the commencement of the meeting.