On March 10, 2020 Delphinus Medical Technologies, Inc., the leader in advanced breast ultrasound technology, has reported that results of a study comparing the use of whole breast ultrasound tomography (UST) and mammography to assess breast cancer risk have been published in the Journal of Clinical Medicine (Press release, Delphinus Medical Technologies, MAR 10, 2020, View Source [SID1234555376]). The study was conducted by researchers at the National Cancer Institute, the Karmanos Cancer Institute, Wayne State University, Henry Ford Health Systems, The Mayo Clinic and George Washington University and was supported by a contract from the National Cancer Institute, part of the National Institutes of Health.

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!

Mammographic percent density (MPD) is an independent risk factor for developing breast cancer. MPD only modestly improves breast cancer risk prediction and is not typically assessed in women under 40 because of ionizing radiation concerns. Previous studies have shown that tissue sound speed, derived from UST, a non-ionizing modality, is a potential surrogate marker of breast density. But prior to this study, sound speed has not been directly linked to breast cancer risk. The study evaluated the relationship of sound speed, using Delphinus’ SoftVue 3D whole breast ultrasound system, and MPD with breast cancer risk in a case-control study. This study compared 61 patients with a recent breast cancer diagnosis with 165 women with no personal history of breast cancer.

This study demonstrated that increasing quartiles of whole breast volume-averaged sound speed were consistently and more strongly associated with increasing breast cancer risk than quartiles of mammographic percent density. These findings were statistically significant and suggest future opportunities for utilizing UST-breast cancer risk assessment, particularly in younger women with the absence of ionizing radiation.

"It is well-established that dense breast tissue is a breast cancer risk factor. This study suggests that whole breast ultrasound tomography may provide stronger and more specific information about that risk than mammography, which may ultimately help to stratify the risk in order to suggest more personalized screening and interventions," said Dr. Rachel Brem, Director, Breast Imaging and Intervention at The George Washington University and the Program Leader, Breast Cancer, at The George Washington Cancer Center. "We are encouraged by the study results that indicate the potential use of whole breast ultrasound to improve the accuracy of breast cancer risk assessment with a non-ionizing breast imaging modality."

Delphinus Chief Technology Officer, Dr. Neb Duric, added, "This study expands the potential application of our platform SoftVue technology beyond diagnostic imaging and breast cancer screening to cancer risk stratification for women at virtually any age, including the approximately 70 million women in the U.S. that are below screening age. We believe that SoftVue imaging may enable individual risk assessment and intervention at an early age, when interventions are the most effective, as well as personalized screening regimens that take into account risk levels."

On March 10, 2020 Century Therapeutics, developer of induced pluripotent stem cell (iPSC)-derived allogeneic cell therapies for cancer, reported the opening of its Seattle-based Innovation Hub to develop next-generation product candidates that overcome barriers that have limited the effectiveness of cell therapies in solid tumor cancers (Press release, Century Therapeutics, MAR 10, 2020, View Source [SID1234555375]).

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 site will advance the company’s novel iPSC science and allogeneic cell products by establishing expertise in data sciences and machine learning, synthetic biology, cancer biology and immuno-oncology. Century’s President of R&D, Hy Levitsky, M.D., will be based at the Seattle site, and together with Philadelphia-based Chief Scientific Officer Luis Borges, PhD., will oversee site operations and integration with the pipeline programs centered at Century’s Philadelphia headquarters.

"The Innovation Hub supports not only Century’s continued pipeline growth and development, but also our expansion into Seattle, a center of excellence in cell therapies," said Lalo Flores, Chief Executive Officer of Century Therapeutics. "I look forward to seeing the Century team grow, and am excited to have Luis and Hy leading the charge into this exciting new chapter."

Dr. Levitsky has extensive biotech industry experience, having previously served as Chief Scientific Officer at Juno Therapeutics in Seattle, as well as Head of Cancer Immunotherapy at Roche Pharma Research and Early Development. In addition, Dr. Levitsky earned his M.D. from Johns Hopkins University and has spent over 20 years on their faculty.

Dr. Borges has extensive cancer immunotherapy and cell therapy experience, having worked at Immunex, Amgen, Five Prime Therapeutics and Cell Medica, where as CSO he led the development of off-the-shelf CAR-cell therapies for the treatment of cancer in collaboration with the Baylor College of Medicine.

"Century’s new Seattle Innovation Hub will provide the infrastructure needed to conduct in-depth analytics of product candidates in preparation for entry into the pipeline portfolio," said Dr. Levitsky.

"The Hub will be key in realizing the potential of Century’s science to overcome limitations of first-generation cell therapies." Dr. Borges added, "The Seattle and Philadelphia research laboratories will complement each other. With our current deep expertise in iPSC biology, immunology, cell and protein engineering, the new group in Seattle will help us transition to future generation products designed to have potent anti-tumor efficacy and robust safety windows."

On March 10, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that Clay Siegall, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the Barclays Global Healthcare Conference on Wednesday, March 11, 2020 at 4:20 p.m. Eastern Time (Press release, Seattle Genetics, MAR 10, 2020, View Source [SID1234555374]). The conference will be held in a virtual meeting format. The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

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!

On March 10, 2019 XOMA Corporation (Nasdaq: XOMA) reported its fourth quarter and full-year 2019 financial results and business highlights (Press release, Xoma, MAR 10, 2020, View Source [SID1234555373]).

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!

"2019 was a tremendous year for XOMA. We added 20 new assets to our royalty license portfolio, eleven of which are clinical-stage candidates. One of our licensees, Janssen Biotech, conducted a portfolio review and identified multiple compounds that were born from an agreement between our companies. As we are constructing XOMA’s portfolio to generate royalty candidates over an extended time horizon, we acquired interests in two exciting platform technologies that we believe will produce multiple clinical candidates to further increase our royalty license portfolio. We entered 2020 with a royalty-potential portfolio of more than 65 partner-funded assets," stated Jim Neal, Chief Executive Officer at XOMA. "Our business model has the potential to generate significant revenue from milestone payments and royalties. In 2019, we received $15.8 million from our partners. Given our royalty acquisition achievements over the last three years and the opportunities before us, we raised an additional $22 million in a rights offering at the end of the year. We anticipate we will deploy this capital to continue building XOMA’s royalty-interest and milestone-bearing portfolio."

Business Highlights
XOMA completed four milestone and royalty acquisition transactions in 2019 that added eleven new potential royalty-bearing assets and interests in two platform technologies to the Company’s portfolio.

Acquired a milestone and royalty interest in two Bayer assets, one Bayer option, and two unpartnered candidates from Aronora.
Acquired a royalty interest in one Novartis asset and five clinical-stage assets from Palobiofarma.
Acquired royalty interest in platform technologies being developed at Bioasis Technologies and Sonnet BioTherapeutics.
Added nine Janssen Biotech assets to XOMA’s royalty portfolio.
Received $15.8 million from partners during 2019.
Completed a $22 million rights offering with XOMA stockholders including BVF Partners, LP.
2019 Updates About Partnered Assets in Development
"Last year two of our partners, Novartis and Sesen Bio, announced significant clinical developments that have the potential to offer patients with few treatment options the opportunity to access new therapies that have clinically meaningful benefits," Mr. Neal continued.

Novartis-licensed assets:

Novartis presented first-of-its-kind histology data with iscalimab (CFZ533)1 at the American Transplant Congress. The data showed 60 percent of iscalimab-treated transplant patients have normal kidney histology at least one year after transplant, compared with 0 percent with tacrolimus (current standard of care)2. The company highlighted iscalimab and its development plans at the Novartis R&D Day on December 5, 2019. Novartis now has seven clinical studies with iscalimab underway.
Novartis launched its clinical program for gevokizumab (VPM087) (anti-IL1β allosteric modulator monoclonal antibody) 3 with a clinical study in patients with metastatic colorectal cancer, gastroesophageal cancer, and renal cell carcinoma.
Sesen Bio reported positive top-line Phase 3 data and subsequently initiated its rolling Biologics License Application (BLA) filing for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)4. The company has stated it anticipates completing its filing in the second half of 2020.

Takeda-licensed assets:

Takeda expanded the TAK-0794 clinical program and now has four studies ongoing.
Takeda and Molecular Templates began enrolling patients in their first TAK-1694 clinical program.
Aronora initiated a Phase 2 study with AB002 (E-WE thrombin)4 in patients with end-stage renal disease on chronic hemodialysis.

AVEO Oncology expanded the clinical program testing ficlatuzumab (AV-299)4 and now is studying the compound’s potential efficacy in a wide variety of oncology indications.

Mr. Neal concluded, "The clinical advancements continued into 2020. In February, Rezolute, Inc., announced the launch of its Phase 2b clinical trial for RZ358 (formerly XOMA 358) in patients with congenital hyperinsulinism (CHI). Given the insight we gained into this terrible condition during our early development of this compound and the extraordinary families we met, we are truly hopeful Rezolute succeeds in its development efforts for RZ358."

Financial Results
XOMA recorded total revenues of $0.4 million for the fourth quarter of 2019, compared to $1.7 million for the fourth quarter of 2018. For the full year of 2019, XOMA recorded revenues of $18.4 million, compared to $5.3 million for the full year of 2018. Revenues for the full year of 2019 reflect $14.0 million recognized under the Company’s license agreement and common stock purchase agreement with Rezolute and $2.5 million in revenue earned from a one-time payment under XOMA’s license agreement with Janssen. Revenues for the full year of 2018 include $1.8 million recognized under the license agreement and common stock purchase agreement with Rezolute, $1.4 million in milestone revenue earned under XOMA’s license agreement with Janssen, and $0.8 million in milestone revenue earned under XOMA’s license agreement with Compugen.

Research and development (R&D) expenses were $0.1 million for the fourth quarter of 2019, compared to $0.2 million for the fourth quarter of 2018. Research & development expenses for the full year of 2019 were $1.3 million, compared to $1.7 million for the same period in 2018. The decrease of $0.4 million in 2019, as compared with 2018, was primarily due to a reduction in headcount of R&D employees.

General and administrative expenses were $4.3 million for the fourth quarter of 2019, compared to $4.3 million for the fourth quarter of 2018. General & administrative expenses were $21.0 million for the full year of 2019, compared to $18.6 million for the full year of 2018. The increase of $2.4 million in 2019 as compared with 2018 was primarily due to a $0.9 million increase for expenses incurred in connection with a separation agreement with our Chief Business Officer, which included $0.5 million in stock-based compensation expense for modifications to vested stock options and $0.4 million in separation benefits, an increase of $0.7 million in stock-based compensation excluding the option modifications, a $0.6 million increase in common area maintenance charges related to our legacy leases, and a $0.4 million increase in expenses related to investor communications.

Interest expense for the fourth quarter of 2019 was $0.6 million, as compared to $0.4 million for the fourth quarter of 2018. For the full year of 2019, interest expense was $1.9 million, compared with $0.9 million reported in the full year of 2018. The increase in 2019 is primarily due to the increase in the outstanding loan balance with Silicon Valley Bank due to the Company’s borrowing activities related to the royalty purchase agreements with Aronora and Palobiofarma.

Other income, net was $0.3 million for the fourth quarter of 2019, compared to $0.7 million for the corresponding quarter of 2018. Total other income, net was $3.8 million for the full year of 2019, compared to $4.3 million for the corresponding period of 2018. The decrease in the full year of 2019 when compared to the full year of 2018 primarily reflects the discontinuation of income under the Ology Bioservices agreement of $2.5 million and a loss of $0.4 million recognized due to the early termination of our legacy building leases, partially offset by the increase in sublease income of $1.2 million and the change in fair value adjustment of Rezolute common stock of $0.9 million.

Net loss for the fourth quarter of 2019 was $4.3 million, compared to net loss of $3.0 million for the fourth quarter of 2018. Net loss for the full year of 2019 was $2.0 million, compared to net loss of $13.3 million for the full year of 2018.

On December 31, 2019, XOMA had cash of $56.7 million compared with $45.8 million on December 31, 2018. The Company’s current cash position is expected to be sufficient to fund its operations for multiple years.

On March 10, 2020 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Sunesis, MAR 10, 2020, View Source [SID1234555372]). Loss from operations for the three months and year ended December 31, 2019 was $5.4 million and $23.3 million. As of December 31, 2019, cash and cash equivalents, restricted cash, and marketable securities totaled $34.6 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!

"We concluded 2019 having made solid progress across our portfolio. Vecabrutinib, our non-covalent BTK inhibitor, demonstrated a very favorable safety profile combined with evidence of clinical activity in patients with and without BTK C481-mutations. We continue to advance and characterize our proprietary PDK1 inhibitor, SNS-510, with findings supporting development in both hematologic and solid tumors. We are also building value in our product pipeline through partnerships. In December, we partnered vosaroxin with Denovo Biopharma and TAK-580 with DOT Therapeutics-1 to advance these programs to the market," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "Looking ahead, we remain on track to complete the Phase 1b dose escalation component of our Phase 1b/2 vecabrutinib trial in the second quarter and to advance SNS-510 to an IND by the end of year."

Vecabrutinib Phase 1b/2 Clinical Update. Since the presentation of clinical data through cohort 5 at ASH (Free ASH Whitepaper) in December 2019, Sunesis has enrolled patients in cohorts 6 and 7 of the ongoing Phase 1b/2 trial of vecabrutinib.

Cohort 5 (300mg): Sunesis announced at ASH (Free ASH Whitepaper) 2019 that stable disease was observed in three of five patients from cohort 5 (300mg BID). As of today, one chronic lymphocytic leukemia (CLL) patient remains on study in cycle 8 at 300mg BID with a 47% reduction in tumor burden at their second scan, improving from their initial 41% reduction, with normalized hematology parameters.

Cohort 6 (400mg BID): Four patients, three CLL and one diffuse large B cell lymphoma (DLBCL), were enrolled in the cohort. The DLBCL patient was nonevaluable due to disease progression during cycle one. The three CLL patients

completed the safety evaluation period, remain on treatment, and results of their first response assessments will be available later this month.

Cohort 7 (500mg BID): Six patients, four with CLL and two with mantle cell lymphoma (MCL), cleared the safety evaluation period and four of the patients remain on treatment. We expect first response assessments for these patients in the second quarter. Additional patients are being evaluated for the cohort.

Vecabrutinib has been very well tolerated, with no Grade 3 or higher drug-related adverse events reported to date across cohorts 3 – 7.

SNS-510, first-in-class PDK1 inhibitor. In October, at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), Sunesis presented data profiling the oral PDK1 inhibitor SNS-510 showing potent activity in hematologic and solid tumor cancer models. New results of in vitro combination studies indicate that SNS-510 can combine synergistically with several drugs including inhibitors of CDK4/6, KRAS G12C, and BCL2. The IND-enabling program is progressing as planned and an IND filing is targeted for the end of 2020.

Partnering TAK-580 and vosaroxin. In December, Sunesis consented to Takeda Oncology’s assignment of our agreement relating to the pan-Raf inhibitor TAK-580 to DOT Therapeutics-1, Inc. ("DOT-1"). Coincident with the transaction, Sunesis and DOT-1 entered into a new agreement covering TAK-580 and DOT-1 paid Sunesis an upfront fee of $2.0 million. Under the new TAK-580 agreement, DOT-1 agreed to pay Sunesis up to $57.0 million in pre-commercialization milestone payments, plus royalties on future sales of TAK-580. Also in December, Sunesis licensed vosaroxin to Denovo Biopharma LLC ("Denovo"). Sunesis received a $0.2 million upfront payment and is eligible to receive up to $57.0 million in regulatory and commercial milestones, plus double-digit royalties on future sales of vosaroxin.

Financial Highlights

Cash and cash equivalents, restricted cash and marketable securities totaled $34.6 million as of December 31, 2019, compared to $13.7 million as of December 31, 2018. The increase of $20.9 million was primarily due to $45.1 million of net proceeds from the issuance of common and preferred stock, and $5.5 million of proceeds from the SVB loan, partially offset by $22.2 million net cash used in operating activities and a $7.5 million principal repayment of the prior loan from Western Alliance Bank and Solar Capital Ltd.

Revenue was $2.1 million in 2019 compared to $0.2 million in 2018. Revenue in both periods was derived from license agreements. The increase of $2.0 million in 2019 was primarily due to revenue recognized from the upfront payments received under the license agreements with DOT-1 and Denovo.

Research and development expense was $15.4 million in 2019 compared to $14.6 million in 2018, primarily relating to the vecabrutinib development program. The increase of $0.8 million in 2019 was primarily due to a $1.8 million increase in professional services and clinical expenses related to the preparation for the Phase 2 portion of our ongoing clinical trial for vecabrutinib, offset by a $1.0 million decrease in salary and personnel expenses.

General and administrative expense was $9.9 million in 2019 compared to $11.3 million in 2018. The decrease of $1.4 million in 2019 was primarily due to a $1.1 million decrease in salary and personnel expenses due in large part to lower stock-based compensation and a $0.8 million decrease in professional services expenses due to lower legal and vosaroxin patent expenses. The decreases in the comparable periods were partially offset by a $0.3 million increase in insurance premiums.

Interest expense was $0.5 million in 2019 compared to $1.2 million in 2018. The decrease in 2019 was primarily due to lower interest paid under the SVB Loan Agreement compared to the prior loan.

Cash used in operating activities was $22.2 million in 2019, compared to $24.4 million in 2018. Cash used in the 2019 period resulted primarily from the net loss of $23.3 million and changes in operating assets and liabilities of $0.7 million, offset by net adjustments for non-cash items of $1.8 million.

Loss from operations was $5.4 million and $23.3 for the three months and year ended December 31, 2019, compared to $5.8 million and $25.7 million for the same periods in 2018. Net loss was $5.3 million and $23.3 million for the three months and year ended December 31, 2019, compared to $6.0 million and $26.6 million for the same periods in 2018.

Conference Call Information

Sunesis will host a conference call 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 2388763. 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