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.

On March 6, 2018 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, reported that the Company’s management will present an overview and update for the Company, and host investor meetings, at the Cowen 38th Annual Health Care Conference (Filing, 8-K, Supernus, MAR 7, 2018, View Source [SID1234524517]).

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Date: Tuesday, March 13, 2018

Time: 10:00 a.m. ET
Place: The Boston Marriott Copley Place, Boston, Mass.

Investors interested in arranging a meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investor Relations Section on the Company’s website at www.supernus.com. An archived replay of these webcasts will be available for 60 days after the conference on the Company’s website.

On March 7, 2018 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, reported that the Company will present at the 30th Annual ROTH Conference at the Ritz Carlton Laguna Niguel in Dana Point on Tuesday, March 13, 2018 at 7:30 a.m. PT (Press release, Scynexis, MAR 7, 2018, View Source [SID1234524516]).

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A live webcast will be available on the Investors section of the Company’s website: www.scynexis.com. A replay of the presentation will be available approximately two hours after the event and will be available for two weeks following the presentation.

On March 7, 2018 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, reported financial results for the fourth quarter and year ended December 31, 2017 and provided a pipeline update (Press release, Regulus, MAR 7, 2018, View Source [SID1234524515]).

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"2017 was a transitional year for Regulus. We made important changes to our portfolio and applied key learnings from earlier clinical and preclinical programs, which we believe position us for future success," said Jay Hagan, President and Chief Executive Officer of Regulus.

Mr. Hagan continued, "The RG-012 start-up activities and enrollment of patients with Alport syndrome have proven more challenging than anticipated. We have added internal and external resources to accelerate patient recruitment. The Phase I single ascending dose (SAD) study for RGLS4326 is progressing well, and planning for the multiple ascending dose (MAD) portion is underway."

Pipeline Update

• RG-012 for Alport syndrome: Patient recruitment activities for the Phase II HERA and the renal biopsy studies are on-going. Based on revised enrollment assumptions, the Company believes that both studies will be fully enrolled in the second half of 2018.

• RGLS4326 for autosomal dominant polycystic kidney disease (ADPKD): A Phase I SAD study was initiated in December 2017. Data from this study in healthy volunteers will provide pharmacokinetics and safety data, and the study is currently on track for completion in the third quarter 2018.
Financial Results

Cash Position: As of December 31, 2017, Regulus had cash, cash equivalents, and short-term investments of $60.1 million.

Research and Development (R&D) Expenses: R&D expenses were $10.5 million and $53.2 million for the quarter and year ended December 31, 2017, respectively, compared to $15.0 million and $64.3 million for the same periods in 2016. The fourth quarter decrease was primarily the result of a reduction in personnel-related costs, subsequent to our May 2017 corporate restructuring. The year-over-year decrease was further driven by the wind-down of clinical activities related to the RG-101 program.

1

General and Administrative (G&A) Expenses: G&A expenses were $3.3 million and $17.0 million for the quarter and year ended December 31, 2017, respectively, compared to $4.8 million and $18.4 million for the same periods in 2016. The decreases in G&A expenses were primarily attributable to a reduction in non-cash stock-based compensation.

Revenue: Revenue was less than $0.1 million and $0.1 million for the quarter and year ended December 31, 2017, respectively, compared to less than $0.1 million and $1.2 million for the same periods in 2016.

Net Loss: Net loss was $14.4 million and $71.9 million for the quarter and year ended December 31, 2017, respectively, compared to a net loss of $20.0 million and $81.8 million for the same periods in 2016. Basic and diluted net loss per share was $0.14 and $0.96 for the quarter and year ended December 31, 2017, respectively, compared to $0.38 and $1.55 for the same periods in 2016.

Conference Call Details

Regulus will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss fourth quarter financial results and provide a general business update. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 4794278. To access the replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), conference ID 4794278. The webcast and telephone replay will be archived on the company’s website following the call

On March 7, 2018 Protagonist Therapeutics, Inc. (NASDAQ: PTGX) reported its financial results for the fourth quarter and full year ended December 31, 2017 and provided an update on the company’s recent achievements (Press release, Protagonist, MAR 7, 2018, View Source;p=RssLanding&cat=news&id=2336855 [SID1234524514]).

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Protagonist Therapeutics, Inc. (PRNewsFoto/Protagonist Therapeutics, Inc.)

"2017 was a very successful year for Protagonist wherein we strengthened both our R&D pipeline as well as our financial position," said Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "During the year, we entered into a major collaboration with Janssen Biotech Inc., raised a net $64.5 million in a public offering, and ended the year with three products in different stages of clinical development."

"We believe that the company is well positioned for success in 2018," continued Dr. Patel. "We anticipate reporting the interim futility analysis outcome in the first quarter and final top-line results in the fourth quarter from our Phase 2b PROPEL trial of the oral peptide PTG-100. These results, if positive, would demonstrate the potential utility of PTG-100 as an oral targeted therapy for moderate-to-severe ulcerative colitis. During 2018, we also plan to report Phase 1 results from the Janssen collaboration asset PTG-200. Finally, we plan to commence a global clinical trial of PTG-300 in patients with beta-thalassemia and initiate IND enabling studies with our fourth asset PTG-400."

"We ended the year with approximately $155.5 million in cash, cash equivalents, and investments and anticipate having enough funds to support our operations through 2019," Dr. Patel concluded.

2017 Research and Development Highlights:

PTG-100

Protagonist initiated a global Phase 2b trial of alpha-4-beta-7 integrin oral peptide antagonist PTG-100 in approximately 240 patients with moderate-to-severe active ulcerative colitis. An interim futility analysis will be performed in the first quarter of 2018, and final top-line results are anticipated in the fourth quarter of 2018.
The company plans to initiate a Phase 2/3 clinical trial in chronic pouchitis, a rare disease indication, in 2018 pending a positive decision from the interim futility analysis in the ulcerative colitis PROPEL study.
PTG-200

Protagonist entered into a license and collaboration agreement with Janssen Biotech, Inc., a Johnson and Johnson company, to support the clinical development and potential commercialization of PTG-200, a first-in-class oral peptide interleukin-23 receptor (IL-23R) antagonist. Under the terms of the agreement, Protagonist granted Janssen an exclusive worldwide license to PTG-200 and received a $50 million upfront payment in the third quarter of 2017. Protagonist can also receive up to an additional $940 million in payments, including potential license option payments of $125 million at the Phase 2 interim analysis and $200 million at Phase 2 completion, and $615 million in other potential clinical development, regulatory approval, and sales milestones.
Protagonist and Janssen will co-develop and co-fund PTG-200 through Phase 2 clinical development. Janssen will be responsible for funding Phase 3 studies in Crohn’s disease and ulcerative colitis. Protagonist will receive double-digit tiered royalties on future net sales and retains the option to co-detail PTG-200 in the United States.
Protagonist initiated a first-in-human trial of PTG-200 in November 2017. The Phase 1 study is a randomized, double-blind, placebo-controlled, single and multiple dose-escalation trial in normal healthy volunteers. Protagonist and Janssen collaboratively plan to complete this Phase 1 study and anticipate filing a U.S. IND and initiating a global Phase 2 study in Crohn’s disease in the second half of 2018.
PTG-300

Protagonist successfully initiated and completed a Phase 1 randomized, double-blind, placebo-controlled, single dose-escalation and repeat dose study of its hepcidin mimetic PTG-300 in normal healthy volunteers. PTG-300 was found in this study to be safe and well-tolerated at all dose levels. Moreover, in this study, PTG-300 demonstrated its intended dose-related pharmacological effect on serum iron levels, establishing pharmacodynamic clinical proof-of-concept in healthy volunteers. Following our upcoming meetings with the U.S. and European regulatory agencies, the company plans to initiate a global clinical trial of PTG-300 in beta-thalassemia in the second half of 2018.
On March 6, 2018, Protagonist announced that the U.S. Food Administration had granted Orphan Drug Designation to PTG-300 for the treatment of beta-thalassemia.
Corporate Highlights:

Protagonist completed a public offering of 3,530,000 shares of its common stock at a price to the public of $17.00 per share in October 2017. The underwriters exercised their option to purchase an additional 529,500 shares at the public offering price in November 2017. Net proceeds from the offering were approximately $64.5 million.
The company appointed two new members to the Protagonist Board of Directors during 2017: Rusty Williams, M.D., Ph.D., current Executive Chairman and former President and Chief Executive Officer of Five Prime Therapeutics, and Sarah Noonberg, M.D., Ph.D., previously Chief Medical Officer of Prothena Corporation.
Other Highlights

Protagonist was awarded a Phase 2 Small Business Innovation Research Grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health in May 2017. This grant provides up to $1.3 million of funding over two years to support the development of biomarkers useful in the clinical development of IL-23R antagonist agents for the treatment of inflammatory bowel disease (IBD), including PTG-200.
Several key patents issued to Protagonist during 2017 and January 2018 covering the company’s peptide assets. These included U.S. patents No. 9,518,091, covering the company’s alpha-4-beta-7 integrin peptide inhibitors, including PTG-100, and No. 9,809,623, providing further specific protection for PTG-100; U.S. patents No. 9,624,268, providing composition of matter protection for PTG-200 and covering the use of oral peptide inhibitors of IL-23R to treat IBD; and No. 9,822,157, covering peptide mimetics of hepcidin, including PTG-300, and related pharmaceutical compositions.
Financial Results

Protagonist reported a net loss of $37.0 million for the full year 2017, as compared to a net loss of $37.2 million for the prior year. The company reported a net loss of $3.1 million for the fourth quarter of 2017, as compared to a net loss of $11.2 million for the fourth quarter of 2016. The decrease in net loss was driven primarily by license and collaboration revenue recognized during the last half of 2017, which partially offset increased research and development expenses related to PTG-100, PTG-200, and PTG-300 clinical trials and other pre-clinical product candidate studies, and increased general and administrative expenses.

License and collaboration revenue was $20.1 million for the full year 2017 and $11.3 million for the fourth quarter of 2017 and consisted of revenue from activities performed under the agreement with Janssen. Protagonist did not recognize any license and collaboration revenue prior to the third quarter of 2017.

Research and development expenses for the full year 2017 were $46.2 million, as compared to $25.7 million for the prior year. Research and development expenses for the fourth quarter of 2017 were $11.7 million, as compared to $8.8 million for the same period in the prior year. The increase in research and development expense in these periods was due primarily to costs related to contract manufacturing, the preparation for and conduct of PTG-100, PTG-200, and PTG-300 clinical trials, and preclinical development studies for other product candidates.

General and administrative expenses for the full year 2017 were $11.8 million, as compared to $7.0 million for the prior year. General and administrative expenses for the fourth quarter of 2017 were $3.1 million, as compared to $2.6 million for the same period in the prior year. The increase in G&A expense in these periods was due primarily to increases in employee-related expenses, professional service fees, and other administrative expenses to support the growth of our headcount and operations.

Protagonist ended 2017 with $155.5 million in cash, cash equivalents and investments.

Conference Call and Web Cast Information

Protagonist executives will host a conference call at 1:30 p.m. PT/4:30 p.m. ET today. To access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and refer to conference ID number 4054387. The call will also be webcast and will be accessible from "Events & Presentations" in the Investors section of the company’s website at www.protagonist-inc.com. A replay will be available on the company’s website approximately two hours after the call and will remain available for 90 days.