Reata Pharmaceuticals, Inc. Announces Third Quarter 2017 Financial and Operating Results

On November 13, 2017 Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a clinical-stage biopharmaceutical company, reported financial results for the third quarter ended September 30, 2017, and provided an update on the Company’s business and product development programs (Press release, Reata Pharmaceuticals, NOV 13, 2017, View Source;p=RssLanding&cat=news&id=2316419 [SID1234521972]).

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Financial Highlights

The Company incurred operating expenses of $24.6 million for the quarter ended September 30, 2017, with research and development accounting for $18.3 million. This compares to operating expenses of $13.5 million for the same period of the year prior, when research and development accounted for $9.3 million. A net loss of $12.3 million was reported by the Company for the quarter ended September 30, 2017, equating to a loss of $0.50 per share, compared to net loss of $0.9 million or $0.04 per share in the same period of the year prior.

The Company incurred operating expenses of $68.5 million for the nine months ended September 30, 2017, with research and development accounting for $50.8 million. This compares to operating expenses of $40.0 million for the same period of the year prior, when research and development accounted for $27.7 million. A net loss of $31.0 million was reported by the Company for the nine month period ended September 30, 2017, equating to a loss of $1.34 per share, compared to net loss of $2.1 million or $0.11 per share in the same period of the year prior.

Corporate Highlights

As of September 30, 2017, the Company had $154.6 million in cash and cash equivalents.

On November 3, 2017, the Company amended its loan agreement (Amended Loan Agreement) with Oxford Finance LLC and Silicon Valley Bank to increase its Term B Loan amount from $15.0 million to either $20.0 million or $25 million. The Company may, at its sole discretion, borrow $20 million under Term B Loan. An additional $5 million will be available under the Term B Loan for a total of $25 million upon the achievement of one of two milestones. The Company may borrow the Term B Loan by the earlier of 90 days after the achievement of a milestone or June 29, 2018. If the Term B Loan is drawn, the interest-only payment period would be extended by six months.

Product Development Highlights

Bardoxolone Methyl in Rare Kidney Diseases

Chronic Kidney Disease (CKD) Caused by Alport Syndrome

In August, 2017, Reata began enrolling patients in the Phase 3 portion of CARDINAL, a double-blind, randomized, placebo-controlled, multi-center, international trial in patients with CKD caused by Alport syndrome. The trial will enroll approximately 150 patients randomized evenly to either bardoxolone methyl or placebo. The primary endpoint of the trial will be the change from baseline in estimated glomerular filtration rate (eGFR) at 48 weeks while the patient is on treatment, or on-treatment eGFR, and again at 52 weeks after the patient has stopped taking the study drug for a four-week withdrawal period, or retained eGFR. Based upon guidance from the United States Food and Drug Administration (FDA), the year one retained eGFR benefit data may support accelerated approval under subpart H. After withdrawal, patients will be restarted on study drug with their original treatment assignments and will continue on study for a second year, with on-treatment eGFR change measured at 100 weeks, and the retained eGFR benefit after withdrawal of drug for four weeks at week 104. Based upon guidance from the FDA, the year two retained eGFR benefit data may support full approval.

On November 3, 2017, the Company presented positive primary and other 12-week data from the 30 patients in the Phase 2 portion of CARDINAL at the 2017 American Society of Nephrology Kidney Week Annual Meeting (ASN). The Phase 2 study met its primary efficacy endpoint with bardoxolone significantly increasing eGFR after 12 weeks of treatment (p<0.000000001). All patients had an increase from baseline, with a mean increase of 13.4 mL/min/1.73 m2, and 87% had an increase of at least 4 ml/min/1.73 m2, which is the approximate annual rate of decline in kidney function in patients with Alport syndrome. The increases in eGFR translated to an improvement in CKD stage for 22/30 (73%) patients. No serious adverse events were reported, and adverse events were generally mild to moderate in intensity.

On November 4, 2017, Reata’s partner, Kyowa Hakko Kirin, presented results of the TSUBAKI study at ASN. In TSUBAKI, bardoxolone demonstrated statistically significant and clinically meaningful increases in directly-measured glomerular filtration rate (GFR) in patients with type 2 diabetes and CKD using the "gold standard" inulin clearance method. The observed increase in GFR demonstrates that historical increases in eGFR produced by bardoxolone in various forms of CKD, including Alport syndrome, reflect a true increase in kidney function. Bardoxolone demonstrated a favorable safety profile with no effect on blood pressure, urinary volume or sodium retention, and no evidence of overt fluid overload or cardiac toxicity.

Bardoxolone Methyl in Other Rare Kidney Diseases

Based upon results of the Phase 2 portion of CARDINAL, Reata began activating sites in October, 2017 for PHOENIX, a Phase 2 trial of bardoxolone methyl in various rare forms of CKD, including autosomal dominant polycystic kidney disease, IgA nephropathy, type 1 diabetic CKD, and focal segmental glomerulosclerosis. Similar to the Phase 2 portion of CARDINAL, PHOENIX is an open-label trial of bardoxolone orally-administered once-daily for 12 weeks. The primary efficacy endpoint is change from baseline in eGFR at week 12. Approximately 20 to 30 patients will be enrolled per cohort.

Omaveloxolone in Friedreich’s Ataxia (FA)

In October, 2017, the Company began enrolling patients in part 2 of the Phase 2 MOXIe trial, a double-blind, randomized, placebo-controlled, multi-center, international trial in patients with FA. The trial will enroll approximately 100 FA patients randomized evenly to either omaveloxolone or placebo. The primary endpoint of the trial will be the change from baseline in modified Friedreich’s Ataxia Rating Scale (mFARS) of omaveloxolone compared to placebo at 48 weeks. Based upon communications with the FDA, it may consider either accelerated or full approval of omaveloxolone for FA based upon the overall results of the trial and strength of the data.

Bardoxolone Methyl in Pulmonary Arterial Hypertension associated with Connective Tissue Disease

In October, 2016, Reata began enrolling patients in CATALYST, an international, randomized, double-blind, placebo-controlled Phase 3 trial in patients with pulmonary arterial hypertension associated with connective tissue disease (CTD-PAH). Patients will be on up to two standard-of-care vasodilator therapies and will be randomized evenly to either bardoxolone methyl or placebo. The trial will enroll between 130 and 200 patients, with the final sample size determined by a pre-specified, blinded sample size re-calculation based upon 6MWD variability and baseline characteristics of the first 100 patients enrolled in the trial. The primary endpoint of the study is the change from baseline in 6-minute walk distance (6MWD) relative to placebo at Week 24.

IMMUNOMEDICS APPOINTS MICHAEL PEHL PRESIDENT AND CHIEF EXECUTIVE OFFICER TO LEAD NEXT PHASE OF TRANSFORMATIVE GROWTH

On November 13, 2017 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company") reported that its Board of Directors has voted to appoint Michael Pehl as President and Chief Executive Officer ("CEO"), effective December 7, 2017 (Press release, Immunomedics, NOV 13, 2017, View Source [SID1234522004]). He has also been appointed to the Board, effective as of the commencement date of Mr. Pehl’s employment. Immunomedics also announced that Brendan Delaney has been appointed Chief Commercial Officer ("CCO") at Immunomedics, effective as of November 10, 2017. Michael Garone, current Chief Financial Officer ("CFO") and Interim CEO, will resume his role as CFO.

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Discussing the addition of Mr. Pehl, Dr. Behzad Aghazadeh, Chairman of the Board of Immunomedics, stated, "Today’s announcement represents the culmination of an intensely thorough – but ultimately extremely rewarding – search process for the right leader to guide the next phase in the transformation of Immunomedics. As we undertook this task, the Board and I were focused on finding a best-in-class talent with a proven ability to successfully navigate the approval and commercialization of ground-breaking drugs in the oncology space – which we are confident IMMU-132 and other products in our pipeline will be. While Michael’s track record in this area speaks for itself, it was his less tangible qualities that made it clear he was the right choice. As we did our diligence, we repeatedly heard Michael lauded for his strategic vision, operational expertise and confident execution ability. Perhaps most importantly, we time and again heard him singled out for his unique capacity to effectively and compassionately communicate across a spectrum of audiences including patients, KOLs, investors, regulators and fellow team members. This is the type of singular leader we were looking for and are thrilled to have found for Immunomedics."

Mr. Pehl brings to Immunomedics a history of success as a global pharmaceutical leader. Most recently, he served as President, Hematology & Oncology, at Celgene Corporation ("Celgene"), and prior to that was the company’s Head of Global Marketing, Head of Hematology Europe and the first General Manager of Celgene in Germany. Over the course of his 11 years at Celgene, Mr. Pehl has launched multiple blockbuster drugs in the areas of hematology and oncology, including Revlimid, Pomalyst, and Abraxane.

Notably, he has demonstrated an exceptional acumen for realizing lifecycle opportunities and developing pipeline drugs, reflected by the steep revenue growth of Celgene’s Hematology and Oncology business. Under his leadership, Celgene developed and launched the Acute Myeloid Leukemia (AML) drug IDHIFA in industry-record time, and also built an industry-leading pipeline of late and early stage products to treat multiple high-unmet need conditions. Prior to his time as Celgene, Michael served in a number of commercial leadership positions at Amgen in Europe.

Michael Pehl, Immunomedics CEO-designee, stated, "This chance to lead Immunomedics represents a uniquely exciting point-in-time opportunity. Based on the public data on IMMU-132 and available information regarding the Company’s pipeline, I believe the antibody-drug conjugates of Immunomedics have a high likelihood of improving the lives of countless patients with significant unmet medical needs. Now more than ever, this is an absolute priority for me in my career."

Pehl continued, "I was also attracted to this role by the chance to help develop and instill a science based and patient centric culture of performance excellence at Immunomedics. The technology, science and talent the Company has at its disposal are world-class, and I am honored that Behzad and the Board have turned the reins over to me. While the U.S. and global approval and commercialization of IMMU-132 for metastatic triple negative breast cancer are a key goal for me and my team, we simultaneously will be focused on developing IMMU-132 in multiple solid tumor indications, thereby laying the foundation to transform Immunomedics into a recognized leader in the field of antibody-drug conjugates."

Immunomedics also announced today that Brendan Delaney has joined the Company as Chief Commercial Officer. Brendan was most recently Vice President, U.S. Commercial Hematology Oncology at Celgene. In this role, Brendan oversaw a team of roughly 400 professionals across sales, marketing and strategic alliances. Notably, under Brendan’s leadership, the revenue for the group grew to over $7 billion annually, representing a significant proportion of Celgene’s global revenue. Prior to this role, Brendan held a series of other senior-level marketing roles at Celgene. Before coming to Celgene he was at Novartis for five years, serving in a number of U.S. and global marketing roles within the Company’s oncology business unit. Over the course of his 22-year commercial career Brendan has been involved in the launch of nine new oncology products and indications.

In his role as CCO at Immunomedics, Brendan will be responsible for building out the Company’s commercialization team including sales, marketing, market access and pricing. He will report directly to Michael Pehl.

Dr. Aghazadeh said, "Brendan is one of the top commercial leaders in oncology, with deep experience managing cross-functional teams and successfully launching high-value oncology drugs. We believe he is the ideal candidate to lead the launch of the IMMU-132 franchise. Further, Brendan is a truly collaborative and strategic leader who understands how to optimally organize and deploy the commercial function of a top-tier biotech company, making him an excellent fit for where we are at Immunomedics – and more importantly – where we are going as we become a commercial organization ourselves."

Brendan Delaney, Chief Commercial Officer, Immunomedics, stated, "I am thrilled to take on the challenge of building a commercial unit from the ground up at Immunomedics. What makes the opportunity even more exciting is my belief that IMMU-132 will truly address a high unmet need for patients and potentially serve as foundational therapy for multiple solid tumor indications. Additionally, I have deep respect for Michael Pehl from our time working together at Celgene and cannot wait to collaborate to define and execute the commercial strategy at Immunomedics."

BioTime to Participate in Upcoming Conferences

On November 13, 2017 BioTime, Inc. (NYSE American: BTX), a late stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases, reported that its management will participate in the following conferences (Press release, BioTime, NOV 13, 2017, View Source;p=RssLanding&cat=news&id=2316395 [SID1234521958]):

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Torrey Hills Capital Emerging Growth Conference on Tuesday, November 14, 2017. This conference is being held at the Morgan Run Club and Resort in Rancho Santa Fe, CA.
LD Micro 10th Annual Main Event Conference on Wednesday, December 6, 2017. This conference is being held at the Luxe Sunset Boulevard Hotel in Los Angeles, CA.
At each conference mentioned above the Company will be hosting one-on-one and group meetings throughout the day. Analysts and portfolio managers that wish to attend the conference or would like to request a meeting should contact Torrey Hills Capital or LD Micro.

Adaptimmune Presents Study Designs for Ongoing MAGE-A4 and NY-ESO SPEAR T-cell Clinical Trials at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 13, 2017 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in T-cell therapy to treat cancer, reported that it is presenting two trials in progress posters summarizing study designs for ongoing clinical trials with MAGE-A4 and NY-ESO SPEAR T-cells at the 2017 SITC (Free SITC Whitepaper) annual meeting at the Gaylord National Hotel & Convention Center in National Harbor, Maryland, United States (Press release, Adaptimmune, NOV 13, 2017, View Source [SID1234521993]).

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Overview of Study Designs:

· MAGE-A4 SPEAR T-cells targeting multiple solid tumors(1):

· Open-label, non-randomized pilot study evaluating the safety, tolerability, and antitumor activity of MAGE-A4 SPEAR T-cells in patients with HLA-A*02 and MAGE-A4 positive inoperable locally advanced or metastatic tumor(s)

· This dose escalation study utilizes a modified 3+3 design:

· Group 1: to enroll 3-6 patients; dose of 100 million transduced SPEAR T-cells, 21-day interval for safety review

· Group 2: to enroll 3-6 patients; dose of 1 billion transduced SPEAR T-cells, 7-day interval for safety review(2)

· Group 3: to enroll 3-6 patients; dose of 1-5 billion transduced SPEAR T-cells, 7-day interval for safety review(2)

· Study allows for expansion at optimal dose range up to 20 patients across tumors

· Patients must be: > 18 yrs old; HLA-A*02 positive; have MAGE-A4 positive inoperable locally advanced or metastatic tumor(s) at >1+ intensity in > 10% of tumor cells MAGE-A4 expression by immunohistochemistry (IHC); have ECOG status 0 or 1; and adequate organ function

· Lymphodepletion regimen: fludarabine (30mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days

· Efficacy assessed by overall response rate, time to response, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 12, month 6, and then every 3 months until confirmation of disease progression

· The study is open and enrolling

· NY-ESO SPEAR T-cells with or without KEYTRUDA(pembrolizumab) in multiple myeloma:

· Open-label, randomized pilot study evaluating the safety, tolerability, and antitumor activity of NY-ESO SPEAR T-cells with or without KEYTRUDA in patients with multiple myeloma

· Eligible patients will be randomly assigned to a treatment arm: NY-ESO SPEAR T-cells alone (Arm 1) or NY-ESO-1 SPEAR T-cells in combination with KEYTRUDA (Arm 2)

(1) Urothelial cancer (transitional cell cancer of the bladder, ureter or renal pelvis), melanoma, squamous cell carcinoma of the head and neck, ovarian cancer, NSCLC (squamous, adenosquamous, or large cell), esophageal (squamous and adenocarcinoma) or gastric cancer

(2) If, in Group 1 or Group 2, 1 out of 3 patients experiences a dose limiting toxicity (DLT) requiring expansion of an additional 3 patients (n=6), the subsequent observation periods in Group 2 or Group 3 will be increased from 7 days to 14 days for the respective groups.

· Target enrollment is 20 patients with 10 in each arm; eligible patients who do not receive the T-cell infusion may be replaced.

· Patients must be: > 18 yrs old; HLA-A*02:01, *02:05, or *02:06 positive; have histologically confirmed diagnosis of multiple myeloma with either primary refractory or relapsed/refractory disease expressing NY-ESO-1 and/or LAGE-1a; have received prior therapies including IMiD and a proteasome inhibitor as separate lines or a combined line of therapy; have ECOG status 0 or 1; and adequate organ function

· Lymphodepletion regimen: fludarabine (30mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days, followed by granulocyte-colony stimulating factor

· For patients in Arm 2, KEYTRUDA will be administered every 3 weeks, starting at week 3 following T-cell infusion until week 108

· Target dose of 1 – 8 × 109 transduced SPEAR T-cells

· Efficacy will be assessed by the International Myeloma Working Group (IMWG) Uniform Response Criteria. Overall response rate, time to response, duration of response, progression-free survival, and overall survival will be determined.

· The study is open and enrolling

Arcus Biosciences Announces $107 Million Series C Financing Led by GV and Initiation of Two Clinical Trials

On November 13, 2017 Arcus Biosciences, a clinical-stage biotechnology company focused on the discovery and development of innovative cancer immunotherapies, reported the completion of a $107 million Series C financing (Press release, Arcus Biosciences, NOV 13, 2017, View Source [SID1234521995]). This financing brings the total equity capital that the company has raised since its inception in 2015 to $227 million.

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The proceeds from this financing will be used for the advancement of Arcus’s clinical programs for AB928, a first-in-class dual adenosine receptor antagonist, and AB122, a PD-1 antibody. Earlier this month, Arcus initiated a phase 1 trial of AB928 in healthy volunteers and Arcus plans to initiate a phase 1/2 trial of AB928 in combination with AB122 in cancer patients during the first half of 2018. Also in November, Arcus initiated a phase 1 trial of AB122 in cancer patients in Australia. Data from the AB122 trial will be available in 2018 and Arcus plans to evaluate AB122 in combination with its other product candidates, in addition to AB928, in the future. The proceeds raised will also allow Arcus to advance at least two additional product candidates into clinical development, including AB680, a first-in-class small molecule CD73 inhibitor, and AB154, a TIGIT antibody.

The financing was led by GV (formerly Google Ventures), with participation from new investors, including Wellington Management Company LLP, EcoR1 Capital, BVF Partners L.P., Decheng Capital, Hillhouse, Aisling Capital and entities affiliated with Leerink Partners. Arcus’s existing investors, including The Column Group, Foresite Capital, Invus Opportunities, DROIA, Celgene Corporation and Taiho Ventures, also participated in the financing.

"We are extremely pleased to add several outstanding investors with significant expertise in biotechnology to our investor group," said Terry Rosen, Ph.D., CEO of Arcus Biosciences. "We have been assembling a team of staff, investors, leadership and advisors with a highly aligned long-term vision to create, develop and commercialize innovative cancer immunotherapies that may offer a meaningful benefit to patients over existing treatments. These new investors share this vision, and we are thrilled to add their expertise, leadership and commitment to our team."