Vical Reports First Quarter 2018 Financial and Operational Results

On May 3, 2018 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended March 31, 2018. Net loss for the first quarter of 2018 was $6.3 million, or $0.29 per share, compared with a net loss of $2.8 million, or $0.25 per share, for the first quarter of 2017 (Press release, Vical, MAY 3, 2018, View Source [SID1234526014]). Revenues for the first quarter of 2018 were $0.7 million, compared with revenues of $3.2 million for the first quarter of 2017, reflecting revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Vical had cash and investments of $58.3 million at March 31, 2018. The Company’s cash burn for the first quarter of 2018 was $4.6 million, which was consistent with the Company’s full year 2018 guidance of between $20 million and $24 million.

Program updates include:

VCL-HB01 HSV-2 Therapeutic Vaccine

Vical expects to announce top-line results from a Phase 2 study of its HSV-2 therapeutic vaccine during the second quarter of 2018. The last subject in the study has now completed nine months of surveillance; the primary endpoint of annualized recurrence rate will be calculated based on recurrences that are both clinically- and virologically-confirmed. This endpoint provides important information on the number of genital lesion recurrences over time in this chronic disease setting and is clinically meaningful for both patients and treating physicians. The Phase 2 study is being conducted in HSV-2 seropositive healthy adult subjects, 18 to 50 years of age who are randomized 2:1 to receive either vaccine or placebo.
VL-2397 Antifungal Drug

During the first quarter of 2018, Vical initiated a Phase 2 trial comparing VL‑2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (ClinicalTrials.gov Identifier: NCT03327727). The Company intends to conduct the trial in approximately 40 major cancer and transplantation centers in North America, Europe and Asia. The FDA has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis for patients with limited treatment options. The FDA has also granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL‑2397 for the treatment of invasive aspergillosis. Only one new class of antifungal therapy has been approved in the last 30 years. VL-2397 has a novel mechanism of antifungal action and could be the first therapeutic in a new class of antifungals. VL-2397 was isolated from a leaf litter fungus in a Malaysian national park, and was in‑licensed from Astellas in 2015.
Hepatitis B Virus (HBV) Therapeutic Drug

The Company is pursuing preclinical development of a novel treatment for chronic HBV infection based on its DNA and lipid-delivery technologies. The initial aim of this program will be to demonstrate proof of concept for inhibiting HBV infection in an in vivo model. This preclinical development effort is being conducted in collaboration with Vical’s partner, AnGes, Inc. of Osaka, Japan.
Vical will conduct a conference call and webcast today, May 3, at noon Eastern Time, to discuss the Company’s financial results and program updates. The call and webcast are open on a listen-only basis to any interested parties. To listen to the conference call, dial in approximately ten minutes before the scheduled call to (323)794-2567 (preferred), or (888)278-8469 (toll-free), and reference confirmation code 1443635. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719)457-0820 (preferred) or (888)203-1112 (toll-free) and enter replay passcode 1443635. The webcast will also be available live and archived through the events page at www.vical.com. For further information, contact Vical’s Investor Relations department by phone at (858)646-1127 or by e-mail at [email protected].

Spectrum Pharmaceuticals Announces Exclusive Licensing Agreement on Certain Methods of Use of Poziotinib with The University of Texas MD Anderson Cancer Center

On May 3, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported an exclusive licensing agreement with The University of Texas MD Anderson Cancer Center for intellectual property related to certain methods of use of poziotinib (Press release, Spectrum Pharmaceuticals, MAY 3, 2018, View Source [SID1234526013]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have been aggressively pursuing the potential of exon 20 mutations and treatment with poziotinib since the inception of our relationship with MD Anderson, but we’ve both only begun to scratch the surface of the science and poziotinib’s potential as a targeted treatment for various solid tumors," said Joe Turgeon, president and CEO of Spectrum Pharmaceuticals. "Late-stage poziotinib clinical data targeting the exon 20 mutations are promising, and we are thrilled to enter this new agreement that strengthens and potentially extends our patent protection until 2037 as we continue this journey of discovery together."

"Dr. John Heymach and his Lung Cancer Moon Shot team uncovered the potential of Spectrum’s drug poziotinib to help a neglected group of lung cancer patients and then worked closely with the company to bring this targeted therapy to clinical trial rapidly," said Ferran Prat, Ph.D., J.D., MD Anderson senior vice president, research administration and industry relations. "We are delighted to continue our collaboration with Spectrum under this agreement, which highlights how MD Anderson allies with private sector partners to provide new options for cancer patients."

Under the terms of the agreement, Spectrum has been granted a license that includes rights to filed patents related to exon 20 as well as any unidentified discoveries related to the use of poziotinib that may come from Dr. Heymach’s lab at MD Anderson in the future. The filed patents, if granted, are expected to extend the intellectual property protection to 2037. This agreement with MD Anderson further solidifies and extends Spectrum’s intellectual property protection for poziotinib.

About Poziotinib

Poziotinib is a novel, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received exclusive license to develop, manufacture, and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumor indications.

Kura Oncology to Present at Deutsche Bank 43rd Annual Health Care Conference

On May 3, 2018 Kura Oncology, Inc. (Nasdaq:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported its participation in the Deutsche Bank 43rd Annual Health Care Conference (Press release, Kura Oncology, MAY 3, 2018, View Source [SID1234526012]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present an overview of the company on Wednesday, May 9, 2018 at 10:40 a.m. ET / 7:40 a.m. PT. The conference will be held from May 8-9, 2018 in Boston.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be available in the Investors section of Kura Oncology’s website at www.kuraoncology.com, with an archived replay available for 30 days following the event

Karyopharm to Report First Quarter 2018 Financial Results on May 10, 2018

On May 3, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that it will report first quarter 2018 financial results on Thursday, May 10, 2018 (Press release, Karyopharm, MAY 3, 2018, View Source [SID1234526011]). Karyopharm’s management team will host a conference call and audio webcast at 8:30 a.m. ET on Thursday, May 10, 2018 to discuss the financial results and recent business developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the conference call, please dial (855) 437-4406 (local) or (484) 756-4292 (international) at least 10 minutes prior to the start time and refer to conference ID 6798355. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.

GlycoMimetics Reports First Quarter 2018 Results

On May 3, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the first quarter ended March 31, 2018 and highlighted recent company achievements (Press release, GlycoMimetics, MAY 3, 2018, View Source [SID1234526009]). Quarter-end cash as a result of a follow-on financing in March was $242.6 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our first-quarter 2018 accomplishments reflected both progress and transformation for GlycoMimetics. During this period, we laid a foundation – operationally and financially – from which we believe we will drive significant value creation. This foundation was built on the achievement of several key milestones, most notably, the announced design for our Phase 3 trial in relapsed/refractory acute myeloid leukemia (AML) patients, which forms the core of our comprehensive late-stage clinical development strategy for GMI-1271," said Rachel King, GlycoMimetics Chief Executive Officer.

"Our overall plan also includes a trial in Europe to test GMI-1271 in combination with a hypomethylating agent in newly diagnosed patients unfit for intensive chemotherapy. In addition, we continue to explore options for a trial in newly diagnosed patients fit for chemotherapy. Together these trials will position us, if successful, to offer a new standard treatment across the continuum of care in AML. Importantly, we now have the financial resources in place to achieve the key clinical milestones that we believe will drive value creation for the company," she added.

The company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) and entering passcode 1096657. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

Key Operational Highlights for the First Quarter of 2018:

Based on guidance from the US Food and Drug Administration (FDA), the company announced its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in individuals with relapsed/refractory AML. The single pivotal trial is planned to enroll approximately 380 adult patients at 30 to 40 centers in the United States, Canada, Europe and Australia, with enrollment expected to begin in the third quarter of 2018.
The company entered into an agreement with the Haemato Oncology Foundation for Adults in the Netherlands, or HOVON, to initiate clinical trial startup activities to evaluate GMI-1271 in adults with newly diagnosed AML but who cannot tolerate intensive chemotherapy, as well as in patients with myelodysplastic syndrome, or MDS, with a high risk of leukemia.
The company’s strategic partner Pfizer continues to enroll individuals with sickle cell disease in its Phase 3 clinical study of rivipansel for the treatment of vaso-occlusive crisis. GlycoMimetics continues to expect rivipansel to advance to an anticipated topline Phase 3 readout in the fourth quarter of 2018.
First Quarter 2018 Financial Results:

Cash position: As of March 31, 2018, GlycoMimetics had cash and cash equivalents of $242.6 million as compared to $123.9 million as of December 31, 2017. GlycoMimetics successfully completed a follow-on public offering of 8,050,000 shares netting proceeds of approximately $128.4 million.
R&D Expenses: The Company’s research and development expenses increased to $9.0 million for the quarter ended March 31, 2018 as compared to $5.9 million for the first quarter of 2017. The increase was due to on-going costs related to manufacturing and process development for GMI-1271.
G&A Expenses: The Company’s general and administrative expenses increased to $2.9 million for the quarter ended March 31, 2018 as compared to $2.1 million for the quarter ended March 31, 2017. The increase was due to higher patent, legal and non-cash stock-based compensation expenses.
Shares Outstanding: Shares outstanding as of March 31, 2018 were 42,490,110.
About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects. The FDA has granted GMI-1271 Breakthrough Therapy designation for the treatment of adult AML patients with relapsed/refractory disease.

About Rivipansel

Rivipansel, the most advanced drug candidate in the GlycoMimetics pipeline, is a glycomimetic drug candidate that acts as a pan-selectin antagonist, meaning it binds to all three members of the selectin family – E-, P- and L-selectin. The first potential indication for rivipansel is vaso-occlusive crisis (VOC) of sickle cell disease (SCD), one of the most severe complications of SCD which can result in acute ischemic organ injury at one or more sites. By reducing cell adhesion, activation and inflammation that are believed to contribute to reduced blood flow through the microvasculature during VOC, GlycoMimetics believes that rivipansel could be the first drug to interrupt the underlying cause of VOC, thereby potentially enabling patients to leave the hospital more quickly. Pfizer is conducting a Phase 3 clinical trial for rivipansel in SCD.