XOMA Reports Third Quarter 2017 Financial Results

On November 6, 2017 XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery, development and licensing of therapeutic antibodies, reported its third quarter 2017 financial results and recent business highlights (Press release, Xoma, NOV 6, 2017, View Source [SID1234521612]).

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“We made significant progress on multiple fronts executing our new business strategy, and in doing so we completely transformed the Company. The highlight events were clearly the license agreements we secured for both gevokizumab and our IL-1 beta intellectual property portfolio with Novartis. Our strategy was further reinforced with new license agreements for use of our proprietary phage display libraries for antibody discovery. We also received milestone payments from our extensive portfolio of partner-funded programs,” stated Jim Neal, Chief Executive Officer of XOMA. “These third quarter transactions have resulted in a completely revamped balance sheet and multiple years of projected cash runway. With more than two dozen partner-funded programs that have the potential to generate substantial additional milestone and royalty payments, we are very well positioned to deliver sustained growth in the years ahead and create long-term value for shareholders.”

Recent Business Highlights

XOMA made important progress positioning the Company for long-term strategic success:

Licensing the global commercial rights to gevokizumab, a novel anti-IL-1 beta allosteric monoclonal antibody, to Novartis. In a separate agreement, XOMA granted Novartis a license to its intellectual property covering the use of IL-1 beta targeting antibodies in the treatment of cardiovascular disease. Under these agreements, XOMA received $31 million in cash payments, including a $5 million equity investment. The Company is eligible to receive up to $438 million in development, regulatory and commercial milestones plus tiered high-single to mid-double-digit royalties on net sales of gevokizumab. XOMA is also eligible to receive low-single-digit royalties on canakinumab sales in cardiovascular indications, rising to mid-single-digit royalties under certain circumstances. In addition to the upfront payments, Novartis also settled XOMA’s €12 million debt to Servier, and extended the maturity date on the Company’s debt to Novartis from September 2020 to September 2022.
Entering 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 of products.
Earning a $3 million milestone payment related to the clinical advancement of an anti-botulism product candidate the Company licensed to Nanotherapeutics, Inc., in 2015. In September 2017, XOMA received an initial cash payment of $250,000 related to the milestone. The remaining amounts of the milestone payment will be received in monthly payments over the next eleven months. If the product candidate advances from its current stage of development to production and stockpiling by governmental agencies, XOMA is eligible to receive a 15 percent royalty on net sales.
Continuing implementation of the Company’s previously announced aggressive corporate cost reduction plan.
Financial Results

XOMA recorded total revenues of $36.2 million for the third quarter of 2017, compared to $0.6 million for the third quarter of 2016. The increase in revenues for the third quarter 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 $0.3 million for the third quarter of 2017, compared to $8.7 million for the third quarter of 2016. The decrease in R&D expenses for the third quarter of 2017 was due primarily to reductions of $3.5 million in salaries and related expenses, $1.8 million in external manufacturing activities, $1.2 million in the allocation of facilities and information technology costs, $0.9 million in clinical trial costs, and $0.4 million in consulting costs. The decrease in external manufacturing costs included a one-time adjustment of $0.7 million to reverse the cost of a batch of drug material that did not meet quality standards. The significant reduction in R&D spending year-over-year is a result of the execution of the Company’s corporate strategy of leveraging its extensive portfolio of partnered programs and licensed technologies.

General and administrative (G&A) expenses were $7.3 million for the third quarter of 2017, compared to $4.1 million for the third quarter of 2016. G&A expenses for the three months ended September 30, 2017, included increases of $1.9 million in consulting services primarily related to the Company’s license agreements with Novartis, $1.0 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, and $1.0 million in stock compensation cost, partially offset by a $0.6 million decrease in salaries and benefits.

Net income for the third quarter of 2017 was $26.3 million, compared to net loss of $12.5 million for the third quarter of 2016. The significant net income for the third quarter of 2017 was due primarily to the increase in total revenues previously discussed.

On September 30, 2017, XOMA had cash and cash equivalents of $47.7 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.

CTI BioPharma Reports Third Quarter 2017 Financial Results

On November 6, 2017 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the third quarter ended September 30, 2017 (Press release, CTI BioPharma, NOV 6, 2017, View Source;p=RssLanding&cat=news&id=2314662 [SID1234521603]).

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Recent Highlights

Clinical / Regulatory

In July 2017, the first patient was enrolled in PAC203, a Phase 2 clinical trial of pacritinib in patients with primary myelofibrosis who have failed prior ruxolitinib therapy. PAC203 is designed to evaluate the dose response relationship for safety and efficacy (spleen volume reduction at 12 and 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID. The 200 mg BID dose regimen was used in the Phase 3 PERSIST-2 trial of pacritinib in patients with myelofibrosis. The trial is expected to enroll up to approximately 105 patients.
In July 2017, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia (platelet counts less than 100,000 per microliter). Validation confirms that the submission is complete and initiates the centralized review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Board of Directors and Management

In September 2017, Laurent Fischer, M.D. was appointed Chairman of the Board of Directors. Dr. Fischer has more than 20 years of experience in developing and commercializing novel medicines in the biopharmaceutical industry and currently serves as liver therapeutic area head at Allergan following its acquisition of Tobira Therapeutics in 2016.
In September 2017, David H. Kirske was promoted to Chief Financial Officer and Bruce J. Seeley to Chief Operating Officer of the company.
"In the third quarter, we solidified our board and senior management leadership and continue to make significant progress in reducing expenses to operate as a leaner organization as we approach important milestones," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We believe there remains a significant unmet need for myelofibrosis patients with low platelets and continue activating sites in the PAC203 trial of pacritinib. We also look forward to continuing to work with the EMA over the next nine months during their review of the MAA for pacritinib."

Third Quarter Financial Results

Total revenues for the third quarter and nine months ended September 30, 2017, were $1.7 million and $24.7 million, respectively, compared to $4.4 million and $48.3 million for the respective periods in 2016. The decrease in total revenues for the nine months of 2017 is primarily due to recognition of $32 million in milestone revenue related to pacritinib in the first quarter of 2016. Net product sales of PIXUVRI for the third quarter and nine months ended September 30, 2017, were zero and $0.9 million, respectively, compared to $0.9 million and $3.1 million for the respective periods in 2016. The decrease in net product sales for the periods in 2017 compared to 2016, is primarily related to the April 2017 expansion of the PXUVRI agreement with Servier under which they have rights in all markets except the U.S.

GAAP operating loss for the third quarter and nine months ended September 30, 2017, was $11.8 million and $25.8 million, respectively, compared to GAAP operating loss of $28.7 million and $43.6 million for the respective periods in 2016. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the third quarter and nine months ended September 30, 2017 was $10.4 million and $21.5 million, respectively, compared to non-GAAP operating loss of $23.6 million and $32.4 million for the respective periods in 2016. Non-cash share-based compensation expense for the third quarter and nine months ended September 30, 2017, was $1.4 million and $4.3 million, respectively, compared to $5.1 million and $11.2 million for the respective periods in 2016. The decrease in operating loss for the third quarter and nine months of 2017 was due to a significant decrease in research and development and selling, general and administrative expenses primarily related to a decrease in pacritinib development costs as a result of the completion of the Phase 3 clinical studies in 2017 and a decrease in expenses for the manufacture of pacritinib and personnel costs. For information on CTI BioPharma’s use of non-GAAP operating loss and a reconciliation of such measure to GAAP operating loss, see the section below entitled "Non-GAAP Financial Measures."

Net loss for the third quarter of 2017 was $12.0 million, or ($0.28) per share, compared to a net loss of $29.2 million, or ($1.04) per share, for the same period in 2016. Net loss for the nine months ended September 30, 2017, was $30.8 million, or ($0.90) per share, compared to a net loss of $45.6 million, or ($1.63) per share, for the same period in 2016.

As of September 30, 2017, cash and cash equivalents totaled $52.8 million, compared to $44.0 million at December 31, 2016.

Conference Call Information

CTI BioPharma management will host a conference call to review its third quarter 2017 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. PT / 4:30 p.m. ET / 10:30 p.m. CET. Participants can access the call at 1-888-461-2021 (domestic) or +1 719-325-2359 (international). To access the live audio webcast or the subsequent archived recording, visit www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 1048572. The telephone replay will be available until November 13, 2017.

10-Q – Quarterly report [Sections 13 or 15(d)]

Gilead Sciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Gilead Sciences, 2017, NOV 6, 2017, View Source [SID1234521655]).

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Protagonist Therapeutics Reports Third Quarter 2017 Financial Results and Provides Corporate Update

On November 6, 2017 Protagonist Therapeutics, Inc. (NASDAQ: PTGX) reported its financial results for the third quarter and nine months ended September 30, 2017 and provided an update on the company’s recent achievements (Press release, Protagonist, NOV 6, 2017, View Source [SID1234521610]).

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“We recently reported positive preliminary Phase I results for PTG-300, our hepcidin mimetic in development for the potential treatment of anemia and iron overload related blood disorders, including rare diseases such as beta-thalassemia and myelodysplastic syndromes (MDS). These results, coupled with the encouraging Phase I results achieved for PTG-100 in 2016 and the recent partnership with Janssen for PTG-200, all provide validation for our novel peptide platform,” said Dinesh Patel, president and chief executive officer. “We plan to continue to execute on our strategy of optimizing our peptide technology platform and applying it to the discovery and development of drugs that address unmet medical needs and offer strong differentiation against existing treatments.”

Recent Pipeline Achievements

· PTG-300: The company reported preliminary results from a Phase 1 clinical trial of PTG-300, the company’s hepcidin mimetic, which demonstrated pharmacodynamic proof-of-concept in normal healthy volunteers. This data indicated that PTG-300 demonstrated a dose-related reduction in serum iron, which persisted beyond 72 hours at higher dose levels. PTG-300 showed a dose-dependent increase in blood drug levels and was well tolerated with no serious adverse events or dose-limiting toxicities. The company expects to report final top-line results from the complete study in the fourth quarter of 2017.

· PTG-100: The ongoing Phase 2B trial in ulcerative colitis patients remains on track to report interim futility analysis in early 2018 and top-line results in the second half of 2018. In parallel, the company is making all the preparations needed to support Phase 3 development.

· PTG-200: The company closed a license and collaboration agreement with Janssen Biotech, Inc. for clinical development of PTG-200. PTG-200 is expected to enter a Phase 1 clinical trial in the fourth quarter of 2017.

10-Q – Quarterly report [Sections 13 or 15(d)]

Soligenix has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Soligenix, 2017, NOV 6, 2017, View Source [SID1234521596]).

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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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