CombiMatrix has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, CombiMatrix, 2017, NOV 6, 2017, View Source [SID1234521619]).

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 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]).

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 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.

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]).

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 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.

On November 6, 2017 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics, reported the appointment of Professor Paul Workman to its Board (Press release, STORM Therapeutics, NOV 6, 2017, View Source [SID1234561049]). This appointment continues STORM’s evolution of its management and advisory networks as it fulfils its ambition to become the leading therapeutics company in RNA epigenetic modulation.

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!

CEO of STORM Therapeutics, Keith Blundy commented on the appointment: "I am pleased to welcome Paul asIndependent Director to STORM’s board. Paul brings a wealth of experience in cancer biology and drug discovery, in addition to the translational expertise of moving emerging biology to therapeutic applications through his experience of leading a world class cancer institute and being a founder of companies such as Piramed. We look forward to Paul’s input on development and positioning of STORM’s emerging RNA epigenetics platform and programmes."

Professor Paul Workman, Chief Executive and President of The Institute of Cancer Research, London, said: "I am delighted to be joining the board of STORM and working with the company in this exploding area of biology. RNA epigenetic modulation is an exciting area of science with real potential to deliver new targeted cancer therapies. I look forward to working with the board to help guide STORM’s innovative research programmes, adding my experience from drug discovery in academia, pharma and biotech."

On November 6, 2017 Portola Pharmaceuticals Inc. (Nasdaq:PTLA) will report financial results and provide a corporate update for the quarter ended September 30, 2017 (Press release, Portola Pharmaceuticals, NOV 6, 2017, View Source [SID1234521609]).

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!

“Following FDA approval of our first product, Bevyxxa, our team has been working diligently to bring this important new medicine to patients in need, and we are pleased to report good progress with the FDA on achieving product release,” said Bill Lis, chief executive officer of Portola. “We are also continuing to advance AndexXa, the first-ever Factor Xa inhibitor antidote. This treatment is highly anticipated by the medical community and we are continuing discussions with U.S. and European regulatory authorities on our filings for this novel therapy.”

Recent Achievements, Upcoming Events and Milestones

Betrixaban -– an oral, once-daily Factor Xa inhibitor

Bevyxxa (betrixaban) received U.S. Food and Drug Administration (FDA) approval for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE
Committee for Medicinal Products for Human Use (CHMP) opinion anticipated by the end of 2017
Multiple abstracts accepted at the upcoming American Heart Association (AHA) and American Society of Hematology (ASH) (Free ASH Whitepaper) annual meetings
AndexXa (andexanet alfa) – a Factor Xa inhibitor antidote in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening bleeding or when urgent surgery is required; designated a Breakthrough Therapy and an Orphan Drug by the FDA

The FDA has set an action date of February 3, 2018 to respond to our Biologics License Application (BLA)
CHMP opinion anticipated in Q1 2018
Multiple abstracts accepted at the upcoming AHA and ASH (Free ASH Whitepaper) annual meetings
Corporate

Public offering successfully completed in September 2017, the net proceeds of which, including exercise of the underwriters’ over-allotment option, were $380.6 million.
Industry veteran John “Jack” Lawrence, M.D., appointed senior vice president and chief medical officer. Dr. Lawrence previously served as vice president and cardiovascular therapeutic area head for Bristol-Myers Squibb, including global responsibilities for apixaban.
Third Quarter 2017 Financial Results
Collaboration and license revenue earned under Portola’s collaboration and license agreements with Bristol-Myers Squibb Company, Pfizer, Bayer Pharma, Janssen Pharmaceuticals and Daiichi Sankyo was $3.8 million for the third quarter of 2017, compared with $9.3 million for the third quarter of 2016.

Total operating expenses for the third quarter of 2017 were $84.3 million, compared with $100.8 million for the same period in 2016. Total operating expenses for the third quarter of 2017 included $10.1 million in stock-based compensation expense, compared with $7.8 million for the same period in 2016.

Research and development expenses were $55.3 million for the third quarter of 2017, compared with $87.2 million for the third quarter of 2016. The decrease in R&D expenses was largely attributable to a $27.3 million one-time charge taken in the third quarter of 2016 resulting from the Company’s decision to suspend Line C manufacturing at CMC Biologics.

Selling, general and administrative expenses for the third quarter of 2017 were $28.9 million, compared with $13.6 million for the same period in 2016.

For the third quarter of 2017, Portola reported a net loss of $82.9 million, or $1.41 net loss per share, compared with a net loss of $92.9 million, or $1.64 net loss per share, for the same period in 2016.

Cash, cash equivalents and investments at September 30, 2017 totaled $597.8 million, compared with cash, cash equivalents and investments of $318.8 million as of December 31, 2016. The increase is due to the net proceeds of $380.6 million from the Company’s September 12, 2017 public offering.

If the FDA approves andexanet in Q1 2018, the Company will receive an additional $100 million from its royalty-based financing with Health Care Royalty Partners.

Conference Call Details
Portola will host a conference call today, Monday, November 6, 2017, at 4:30 p.m. Eastern Time, during which management will provide updates on the U.S. launch of Bevyxxa, third quarter 2017 financial results and other matters. The live call can be accessed by phone by calling (844) 452-6828 from the United States and Canada or (765) 507-2588 internationally and using the passcode 7269839. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.