OncoCyte to Report First Quarter 2019 Financial Results on Tuesday, May 14

On May 8, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported that it will release its financial and operating results for the first quarter ended March 31, 2019, on Tuesday, May 14, 2019, after the close of the U.S. financial markets (Press release, BioTime, MAY 8, 2019, View Source;p=RssLanding&cat=news&id=2397802 [SID1234535992]). The Company will host a conference call on Tuesday, May 14, 2019 at 4:30 pm ET / 1:30 pm PT to discuss the results along with recent corporate 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!

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13689785. To access the live webcast, go to the investor relations section on the Company’s website, View Source

Sunesis Pharmaceuticals Reports First Quarter 2019 Financial Results and Recent Highlights

On May 8, 2019 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the first quarter ended March 31, 2019. Loss from operations for the three months ended March 31, 2019 was $5.7 million (Press release, Sunesis, MAY 8, 2019, View Source [SID1234535991]). As of March 31, 2019, cash and cash equivalents totaled $24.8 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!

"We continue our focus on the execution of the Phase 1b/2 trial of vecabrutinib and are excited to announce that we have completed the safety evaluation period for the 100 mg cohort, enabling us to advance the trial into the 200 mg cohort," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "To date, vecabrutinib appears to be well tolerated in the context of disease, and we will be providing a clinical update on the study at the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting in June."

Mr. Misfeldt continued, "Underscoring our clinical progress is a strengthened financial position. We began the first quarter by completing an equity offering with leading biotechnology investors, extending our cash runway through important clinical milestones, and just last month we announced the refinancing of our debt on favorable terms through an agreement with Silicon Valley Bank, a vote of confidence in our pipeline and its potential from a premier debt provider for life science companies."

Recent Highlights

Advancement into 200 mg Cohort. The Company has opened the 200 mg cohort in the Phase 1b/2 trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies.

$5.5 Million Loan with Silicon Valley Bank. In April 2019, the Company entered into a $5.5 million loan agreement with Silicon Valley Bank. The new agreement allows the company to retire its existing loan and defer any principal repayment on the new loan for more than 18 months. The new facility includes interest-only payments through 2020, with principal repayment over 24 months beginning in 2021, as well as a lower interest rate than the previous loan. The loan was used for the repayment of the Company’s existing indebtedness.

Completion of $20 Million Financing. In January, Sunesis completed an equity financing with net proceeds of approximately $18.6 million. The financing attracted participation from leading biotechnology investors and will allow Sunesis to advance vecabrutinib through important clinical milestones as the ongoing dose-escalation study explores potentially active dose levels.

Financial Highlights

Cash and cash equivalents totaled $24.8 million as of March 31, 2019, as compared to $13.7 million as of December 31, 2018. The increase of $11.1 million was primarily due to $18.6 million

net proceeds from issuance of common and preferred stock, offset by $6.1 million net cash used in operating activities and $1.4 million principal payment on the Loan Agreement with Western Alliance Bank and Solar Capital Ltd.

Research and development expense was $3.2 million for the three months ended March 31, 2019, as compared to $4.0 million for the same period in 2018. The decrease of $0.8 million between the comparable three-month periods was primarily due to a $0.4 million decrease in salary and personnel expenses due to lower headcount and a $0.4 million decrease in professional services related to higher expenses incurred in the first quarter of 2018 for the start-up cost of Phase 1b/2 trial for vecabrutinib.

General and administrative expense was $2.4 million for the three months ended March 31, 2019, as compared to $3.4 million for the same period in 2018. The decrease of $1.0 million between the comparable three-month periods was primarily due to a $0.7 million decrease in salary and personnel expenses due to lower headcount and a $0.4 million decrease in professional services expenses due in part to lower vosaroxin patent expenses.

Interest expense was $0.3 million for the three months ended March 31, 2019 and 2018. The interest expenses from both periods resulted from payments on our Loan Agreement with Western Alliance Bank and Solar Capital Ltd.

Cash used in operating activities was $6.1 million for the three months ended March 31, 2019, as compared to $6.6 million for the same period in 2018. Net cash used in the three months ended March 31, 2019 resulted primarily from the net loss of $5.9 million, partially offset by adjustments for non-cash items of $0.5 million and changes in operating assets and liabilities of $0.7 million. Net cash used in the three months ended March 31, 2018, resulted primarily from the net loss of $7.3 million and changes in operating assets and liabilities of $0.2 million, offset by net adjustments for non-cash items of $0.9 million.

Loss from operations was $5.7 million for the three months ended March 31, 2019, as compared to $7.1 million for the same period in 2018. Net loss was $5.9 million for the three months ended March 31, 2019, as compared to $7.3 million for the same period in 2018.

Conference Call Information

Sunesis will host a conference today at 4:30 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 1396684. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

Arrowhead Pharmaceuticals Reports Fiscal 2019 Second Quarter Results

On May 8, 2019 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2019 second quarter ended March 31, 2019 (Press release, Arrowhead Research Corporation, MAY 8, 2019, View Source [SID1234535990]). The company is hosting a conference call at 4:30 p.m. EDT to discuss results.

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!

Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 5049067.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 5049067.

Selected Fiscal 2019 Second Quarter and Recent Events

Began dosing in a Phase 1 single and multiple dose study of ARO-ANG3, a subcutaneously administered RNAi therapeutic targeting angiopoietin like protein 3, being developed as a potential treatment for patients with dyslipidemias and metabolic diseases

Began dosing in a Phase 1 single and multiple dose study of ARO-APOC3, a subcutaneously administered RNAi therapeutic targeting apolipoprotein C-III, being developed as a potential treatment for patients with hypertriglyceridemia

Received FDA clearance to begin an adaptive design Phase 2/3 trial, now called SEQUOIA, with the potential to serve as a pivotal registrational study of ARO-AAT, Arrowhead’s second generation subcutaneously administered RNAi therapeutic being developed as a treatment for a rare genetic liver disease associated with alpha-1 antitrypsin (AAT) deficiency

Presented data on both the AAT and hepatitis B programs at the EASL International Liver Congress 2019. Key findings included the following:

Sustained RNAi reduction of the mutant Z-AAT protein in PiZ mice, which harbor the human Z-AAT gene and recapitulate many features of human AAT deficiency liver disease, treated for 33 weeks substantially reversed the disease phenotype

JNJ-3989, formerly ARO-HBV, rapidly reduced hepatitis B surface antigen (HBsAg) in patients that had 24 weeks or more of HBsAg assay results (n=40) to thresholds possibly associated with improved chances of HBsAg seroclearance in many patients, after only 3 doses

100% of patients (40 of 40) achieved ≥1.0 Log10 IU/mL HBsAg reduction

88% of patients (35 of 40) achieved HBsAg <100 IU/mL

JNJ-3989 reduced all measurable viral products, including HBsAg in hepatitis B e-antigen (HBeAg) positive or HBeAg negative patients

JNJ-3989 administered subcutaneously was well tolerated at doses up to 400 mg in all chronic hepatitis B patients

Expanded the AROHBV1001 Phase 1/2 study to include a new triple combination cohort that includes JNJ-3989 and additional undisclosed agents selected by Arrowhead’s partner, Janssen Pharmaceuticals, Inc.

In connection with the start of dosing of this cohort, Arrowhead earned a $25 million milestone payment from Janssen

Adimab Announces Antibody Discovery Platform Transfer with Takeda

On May 8, 2019 Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that it has entered into an agreement to transfer the Adimab Platform to Takeda Pharmaceuticals (Takeda) for the discovery and optimization of antibody- and non-antibody-based protein therapeutics (Press release, Adimab, MAY 8, 2019, View Source [SID1234535974]). This technology transfer expands an ongoing collaboration between the two companies that was initiated in 2016.

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!

The Adimab transfer will provide Takeda with technology licenses at multiple research sites for discovery and optimization of novel modalities across therapeutic areas. This engineering solution provides Takeda the internal capability to engineer different complex molecules as part of its ongoing pipeline diversification strategy in biologics and other modalities.

"Takeda is building a world-class network of capabilities and partnerships to deliver the best therapeutics to address the unmet needs of specific patient populations," said Takeda’s Head of Global Biologics Research, Robert Mabry. "Adimab’s antibody discovery platform will help us diversify our pipeline beyond small molecules, expand our modalities for monoclonal antibody therapeutics, and advance other mechanisms of action enabled by antibody binders, including cell therapies, cytotoxic payloads, immunomodulatory payloads and others."

"For the past three years, we’ve been initiating approximately 35 programs per year internally; this typically involves discovery, optimization and often bispecifics, including using our proprietary CD3 antibodies," said Tillman Gerngross, Chief Executive Officer and Co-Founder at Adimab. "The Adimab Platform can be broadly applied to Takeda’s growing biologics pipeline, across many different modalities, so we’re excited to provide Takeda with the capability to advance its protein-based therapeutic efforts."

"Of the 280-plus Adimab programs initiated to date, almost one-third have come from our Platform Transfer partners, and we see the enablement of more external users as an active area of growth," added Guy Van Meter, Chief Business Officer at Adimab.

Under the terms of the agreement, Takeda will have exclusive access to unique human antibody libraries and will receive a license to the Adimab Platform for use in all therapeutic areas without any target restrictions. Takeda has also secured options to receive continued improvements to the Adimab Platform, including access to new antibody libraries. Adimab will receive an undisclosed upfront fee, future payments upon achievement of specified preclinical and clinical milestones, and royalties on therapeutic products.

Adimab Expands Research Agreement with Regeneron

On May 8, 2019 Adimab, LLC, the leading provider of antibody discovery and optimization technology, reported the expansion of an earlier multi-target research agreement with Regeneron Pharmaceuticals (Press release, Adimab, MAY 8, 2019, View Source [SID1234535973]).

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!

Adimab and Regeneron commenced an initial agreement in December 2014, under which Adimab committed to build a custom common light chain antibody library uniquely for Regeneron and to discover and optimize antibodies against six targets chosen by Regeneron. Thus far, Regeneron has exercised its option for commercial rights to antibodies against one of the six targets. These antibodies are currently undergoing further preclinical research. Under the expanded agreement, Adimab will discover and/or optimize antibodies against six additional targets, and Regeneron will have the right to develop and commercialize any therapeutic program resulting from the collaboration.

"Regeneron is clearly one of the leading biopharma companies in the industry," said Tillman Gerngross, CEO and Co-Founder of Adimab. "Regeneron was very sophisticated in how they leveraged our unique antibody engineering capabilities which may enable therapeutic development against traditionally difficult-to-address targets. We are looking forward to an expanded partnership with this science-minded company."

Under the terms of the agreement, Adimab will use its proprietary yeast-based antibody platform to discover and/or optimize fully human antibodies against up to six additional Regeneron-selected targets. Adimab will receive near-term research fees for each target and is entitled to certain delivery milestones. In addition, for each target, Regeneron will have an option to commercialize antibodies generated during the collaboration, for which Adimab would receive option exercise fees, clinical milestones and royalties on any potential product sales.