XOMA Reports Fourth Quarter and Full Year 2017 Financial Results and Provides

Business Update

On March 7, 2018 XOMA Corporation (Nasdaq: XOMA), a pioneer in the discovery, development and licensing of therapeutic antibodies, reported its fourth quarter and full year 2017 financial results and business highlights (Press release, Xoma, MAR 7, 2018, View Source [SID1234524518]).

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"In 2017, we completely transformed XOMA’s business model and operations. We are now a lean, well- capitalized royalty aggregator with the potential to generate significant future milestone payments and recurring revenue. We added nine new partner-funded programs during the year, including two additional licenses with Novartis. We dramatically reduced our cost structure, eliminated $32 million of short-term debt, and extended our projected cash runway beyond that of most biotechnology companies," stated Jim Neal, Chief Executive Officer of XOMA. "In the year ahead, we plan to further expand our portfolio of partner-funded programs. We have become more aggressive in our activities to acquire potential milestone and royalty revenue streams on additional assets. We also have increased our focus on out- licensing our internally developed product candidates, including our IL-2 program. Ultimately, we believe we will create additional near- and long-term value for shareholders in 2018."

Business Highlights

XOMA made significant progress to position the Company for long-term growth, while strengthening its balance sheet in multiple ways during 2017.

Launched a royalty-aggregator strategy that leverages XOMA’s extensive portfolio of partner- funded programs and licensed technologies that has the potential to generate significant future milestone payments and royalty revenue for the Company.

Completed a $25 million registered offering of common stock and convertible preferred stock to BVF Partners, L.P. (BVF). Associated with this investment, the Company appointed Matthew Perry, President of BVF, a highly accomplished investor and industry professional, to XOMA’s Board of Directors.

Licensed the global development and commercialization rights to gevokizumab, a novel anti-IL-1 beta allosteric monoclonal antibody, to Novartis. XOMA is eligible to receive up to $438 million in development, regulatory and commercial milestones plus tiered high single-digit to mid-teens royalties on net sales of gevokizumab.

Granted Novartis a license to its intellectual property covering the use of IL-1 beta targeting antibodies in the treatment of cardiovascular disease. XOMA is eligible to receive low single-digit royalties on canakinumab sales in
cardiovascular indications, rising to mid single-digit royalties under certain circumstances.

Received $31 million from Novartis in cash payments, including a $5 million equity investment in connection with the gevokizumab and intellectual property licenses.

Settled XOMA’s €12 million debt to Servier as part of the gevokizumab transaction with Novartis, as well as extended the maturity date on the Company’s debt to Novartis from September 2020 to September 2022.

Licensed the global development and commercialization rights for XOMA 358 to Rezolute, Inc., formerly AntriaBio, Inc., a biopharmaceutical company that specializes in developing therapies for metabolic and orphan diseases. XOMA is entitled to receive up to approximately $232 million in potential milestone payments plus royalties ranging from the high single-digits to mid-teens on net sales of RZ358. XOMA also is entitled to receive low single-digit royalties on net sales of AB101 and two other products developed from Rezolute’s extended release and oral plasma kallikrein inhibitor platforms.

Entered into new non-exclusive license agreements with three separate companies, Tizona Therapeutics, Inc., Torch Biosciences, Inc., and LakePharma, for use of XOMA’s proprietary phage display libraries for antibody discovery. Under these agreements, the Company is eligible to receive development and regulatory milestone payments plus single-digit royalties on net sales.

Earned a $10 million milestone payment in May 2017 reflecting the clinical advancement of an asset the Company licensed to one of its pharmaceutical partners.

Earned a $3 million milestone payment related to the clinical advancement of an anti-botulism product candidate the Company licensed in 2015 to Ology Bioservices, Inc.

Repaid the full outstanding balance under the Company’s term loan with Hercules Technology Growth Capital, Inc., which had an outstanding principal balance of $17.5 million as of December 31, 2016.

Completed the Company’s previously announced aggressive cost reductions by decreasing headcount to fewer than 20 employees as of December 31, 2017.

Strengthened the leadership team with the appointment of Dee Datta, Ph.D., as Chief Business Officer.

Financial Results

XOMA recorded total revenues of $5.4 million for the fourth quarter of 2017, compared to $0.5 million for the fourth quarter of 2016. For the full year of 2017, XOMA recorded revenues of $52.7 million, compared to $5.6 million for the full year of 2016. The increase in revenues for the full year of 2017 was due primarily to upfront payments received relating to the Company’s license agreements with Novartis in August 2017.

Research and development (R&D) expenses were $0.7 million for the fourth quarter of 2017, compared to $8.2 million for the fourth quarter of 2016. R&D expenses for the full year of 2017 were $7.9 million, compared to $44.2 million for the same period in 2016. The decrease in R&D expenses for the full year of 2017 was due primarily to reductions of $12.9 million in salaries and related expenses, $8.5 million in external manufacturing activities, $7.6 million in clinical trial costs, $4.0 million in the allocation of facilities and information technology costs, and $1.0 million in consulting costs. The significant reduction in R&D spending year-over-year is a result of the execution of the Company’s royalty-aggregator business model that leverages its extensive portfolio of partnered programs and licensed technologies.

General and administrative (G&A) expenses were $6.7 million for the fourth quarter of 2017, compared to $5.2 million for the fourth quarter of 2016. G&A expenses were $24.3 million for the full year of 2017, compared to $18.3 million for the full year of 2016. The increase in G&A expenses for the full year of 2017 was due primarily to increases of $4.0 million in the allocation of facilities and information technology costs due to a greater proportion of general and administrative personnel after the Company’s restructuring activities, $2.9 million in third party costs related to the execution of license agreements, including the two Novartis agreements in August 2017, and $2.2 million in stock-based compensation. The increases are partially offset by decreases of $2.8 million in salaries and related costs due to the Company’s restructuring activities in 2016 and 2017 and $1.0 million in legal fees.

Restructuring charges for the full year of 2017 were $3.4 million, compared to $4.6 million for the full year of 2016. These charges related primarily to severance, other termination benefits and outplacement services associated with the Company’s restructuring activities in 2017.

Net loss for the fourth quarter of 2017 was $1.3 million, compared to net loss of $17.5 million for the fourth quarter of 2016. Net income for the full year of 2017 was $14.6 million, compared to net loss of $53.5 million for the full year of 2016. The significant net income for the full year of 2017 was due primarily to the increase in total revenues and decrease in R&D expenses previously discussed.

On December 31, 2017, XOMA had cash and cash equivalents of $43.5 million. The Company ended December 31, 2016, with cash and cash equivalents of $25.7 million. The Company’s current cash and cash equivalents are expected to be sufficient to fund its operations for multiple years.

Alexion to Present at the Cowen and Company 38th Annual Health Care Conference

On March 7, 2018 Alexion Pharmaceuticals (Nasdaq: ALXN) reported that management will present at the Cowen and Company 38th Annual Health Care Conference in Boston on Tuesday, March 13, 2018 at 9:20 a.m., ET (Press release, Alexion, MAR 7, 2018, http://news.alexionpharma.com/press-release/financial-news/alexion-present-cowen-and-company-38th-annual-health-care-conference [SID1234524497]).

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An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

Zymeworks to Present at Barclays 2018 Global Healthcare Conference

On March 7, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will present at the upcoming Barclays Global Healthcare Conference taking place March 13-15, 2018 in Miami Beach, Florida (Press release, Zymeworks, MAR 7, 2018, View Source [SID1234524519]).

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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

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The company’s presentation will be March 13, 2018 at 10:45 a.m. Eastern Time. Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website which will also host a recorded replay available afterwards.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

ImmunoGen has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, ImmunoGen, 2018, MAR 7, 2018, View Source [SID1234524547]).

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Daiichi Sankyo Initiates Phase 2 Study of DS-8201 in Patients with HER2-Expressing Advanced Colorectal Cancer

On March 7, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the first patient has been dosed in a global phase 2 study evaluating the safety and efficacy of DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), in patients with HER2-expressing advanced colorectal cancer who have received at least two prior lines of standard treatment (Press release, Daiichi Sankyo, MAR 7, 2018, View Source [SID1234524505]).

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An increase in the number of approved targeted therapies for advanced colorectal cancer over the past decade has helped improve outcomes for some patients, however efficacy and tolerability of second and third-line treatments remain limited.[1], [2], [3], [4], [5]Approximately 3 percent of colorectal cancers overexpress the HER2 protein, which is a well-established therapeutic target in breast and gastric cancer.1 In addition, research indicates that HER2 amplification may be associated with resistance to anti-epidermal growth factor receptor (EGFR)-targeted therapy and shorter survival.[6],[7] Currently, no approved HER2-targeting therapies exist for patients with colorectal cancer.

"Given the existing unmet medical need for advanced colorectal cancer, we are exploring the smart delivery of chemotherapy with DS-8201 as a potential new type of targeted treatment for patients with HER2-expressing disease who have progressed on or become resistant to standard therapies," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "Similar to our breast and gastric cancer programs, we are pursuing a development path focused first on patients with HER2-overexpressing tumors followed by potential expansion to include patients with advanced colorectal cancer with lower levels of HER2 expression."

About the DS-8201 Colorectal Cancer Phase 2 Study

The global, multi-center, phase 2, open-label, three-cohort study will investigate the safety and efficacy of DS-8201 in patients with HER2-expressing advanced colorectal cancer. The first part of the study will enroll patients with HER2-positive (defined as IHC3+ or IHC2+/ISH+) advanced colorectal cancer. The primary endpoint of the study is overall response rate. Secondary endpoints include progression-free survival, overall survival, duration of response, disease control rate, pharmacokinetics and safety. Exploratory endpoints include time to response and biomarker analysis. This part of the study is expected to enroll approximately 50 patients in North America, Europe and Japan.

Following the outcome of the first part of the study, two additional exploratory cohorts may proceed to enroll patients whose tumors have lower levels of HER2-expression. For more information about the study, visit ClinicalTrials.gov.

About Colorectal Cancer

Colorectal cancer is the third most common cancer worldwide. In 2012, there were approximately 1.36 million new cases diagnosed and 690,000 deaths worldwide.[8] Approximately 25 percent of patients have metastatic disease at diagnosis, meaning the disease has spread to distant organs, and about 50 percent of patients with colorectal cancer will eventually develop metastases.[9] Prognosis for these patients remains poor.[10]

About DS-8201

DS-8201 is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, DS-8201 is a smart chemotherapy comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

In addition to the phase 2 study in HER2-expressing advanced colorectal cancer, DS-8201 is currently in pivotal phase 2 clinical development for HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01) in North America, Europe and Asia, and pivotal phase 2 development for HER2-positive advanced gastric cancer resistant or refractory to trastuzumab (DESTINY-Gastric01) in Japan and South Korea. DS-8201 is also in phase 1 development for other HER2-expressing advanced/unresectable or metastatic solid tumors.

DS-8201 has been granted Breakthrough Therapy designation for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1), and Fast Track designation for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including T-DM1 by the U.S. Food and Drug Administration (FDA). DS-8201 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.