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Innovation Pharmaceuticals Provides Corporate Update Highlighting Business Development and Clinical Pipeline Priorities

On November 8, 2018 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, is reported its update highlighting business development and clinical pipeline priorities across its first-in-class drug candidates, Brilacidin, Prurisol and Kevetrin (Press release, Innovation Pharmaceuticals, NOV 8, 2018, View Source [SID1234531088]).

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"A successful End-of-Phase 2 FDA meeting for our Brilacidin-Oral Mucositis asset, or positive results from our Phase 2b Prurisol trial in psoriasis—either outcome we believe would open up enormous possibilities for our shareholders," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "We look forward to updating shareholders on these, and other company developments, as we continue to lay a strong scientific foundation upon which future successes can be built."

Corporate priorities, and upcoming events, include:

Convening the End-of-Phase 2 meeting with the Food and Drug Administration (FDA) to discuss the expedited development of Brilacidin-Oral Mucositis. The meeting, scheduled for later this quarter, helps align with the FDA on clinical trial design and other program requirements.

Analyzing Prurisol topline results in Psoriasis once full payment can be made to the Contract Research Organization (CRO) based on amounts owed, which were, in part, more than budgeted due to significant cost overruns. A partial payment was recently made, with additional payments planned.

Selecting a CRO to complete the necessary remaining bridging toxicology work, approximately half of which has been completed, toward developing Kevetrin (our p53-modulating anti-cancer drug) in oral formulation and commencing its next clinical trial. As Kevetrin is not cytotoxic, the possibility exists for an oral version of Kevetrin to commence a Phase 1/1b study in healthy subjects, followed by a Phase 2 study—shortening the development timeline significantly.

Continuing to advance partnership discussions, with our primary objective to complete licensing deals that provide access to non-dilutive capital to move our clinical assets forward in the most expeditious and cost-effective manner.

Manufacturing Brilacidin final drug substance/drug product for a future, and potentially pivotal, Oral Mucositis clinical trial and, more broadly, for the bulk production of commercial-grade drug supply. The Company has already paid contracted vendors over $1 million toward project completion.

Presenting a scientific poster on Brilacidin for Inflammatory Bowel Disease (IBD) at the "IBD Innovate 2018" conference sponsored in part by the Crohn’s & Colitis Foundation and held in New York City. The poster will be available in the Events and Presentations section of the Company website on November 13, 2018.

Expanding the Company’s Intellectual Property when appropriate, as was recently completed in relation to Brilacidin—the U.S. Patent & Trademark Office announcing allowances directed to oral, buccal, and sublingual pharmaceutical compositions of the drug.

Developing an oral formulation of Brilacidin to treat more extensive forms of IBD (e.g., Ulcerative Colitis and Crohn’s Disease) and a topical formulation of Brilacidin for Inflammation and Immunology (I&I) conditions (e.g., Atopic Dermatitis and Acne), in preparation for subsequent clinical trials.

vTv Therapeutics Announces Third Quarter 2018 Results and Update

On November 8, 2018 vTv Therapeutics Inc. (Nasdaq: VTVT) reported financial results for the third quarter that ended September 30, 2018, and provided an update on recent achievements and upcoming events (Press release, vTv Therapeutics, NOV 8, 2018, View Source;p=irol-newsArticle&ID=2376419 [SID1234531087]).

"We continue to believe in the therapeutic potential of azeliragon and are committed to finding the optimal development pathway forward for the program," said Steve Holcombe, chief executive officer, vTv Therapeutics. "We are also making progress with our other programs, either internally in the case of our GKA program, or through our licensing partners for our GLP-1R agonist, PPAR-delta, and PDE4 programs. We hope to see milestones achieved for each of these programs during 2019."

Recent Achievements and Outlook

Presentation of data at 11th Clinical Trials on Alzheimer’s Disease. Presented positive post-hoc subgroup data indicating a potential benefit of treatment with azeliragon in Alzheimer’s disease patients with type 2 diabetes. This subgroup included 55 patients with glycosylated hemoglobin (HbA1c) of greater than 6.5% at baseline (HbA1c greater than 7.7% was an exclusion criterion at screening) and a clinical diagnosis of Alzheimer’s disease in the combined A-Study and B-Study of the STEADFAST trial. The azeliragon-treated group in the A-Study (n=18) demonstrated a 6.1 point benefit on ADAS-cog relative to the placebo group (n=8), which was nominally statistically significant (p = 0.005), and a 1.7 point benefit on CDR-sb relative to placebo (p = 0.08) after 18 months of treatment.
Meeting with European Medicines Agency. Met with the Scientific Advice Working Party (SAWP) of the EMA on October 30, 2018, to discuss future development requirements in support of seeking regulatory approval of azeliragon in the European Union. We expect to receive formal guidance from the SAWP during the fourth quarter of 2018.
SimplicT-1 Study enrolling patients with type 1 diabetes. The adaptive Phase 1/2 SimplicT-1 Study continues to enroll patients with type 1 diabetes in a 12-week study to evaluate TTP399 as an add-on to insulin therapy. We expect to have an interim read-out of the results of this study in early 2019. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes.
Upcoming Events

vTv will participate in the following upcoming investor conferences:

Piper Jaffray 30th Annual Healthcare Conference, November 27-29, New York, NY
J.P. Morgan 37th Annual Healthcare Conference, January 7-10, San Francisco, CA
Second Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents as of September 30, 2018, were $3.8 million compared to $1.2 million as of June 30, 2018.
R&D Expenses: Research and development expenses were $2.7 million in the third quarter of 2018, compared to $8.6 million in the second quarter of 2018. The decrease in research and development expenses was primarily driven by the termination of the STEADFAST and open label extension studies during the second quarter of 2018.
G&A Expenses: General and administrative expenses were $2.2 million and $2.7 million, for the third quarter of 2018 and the second quarter of 2018, respectively. General and administrative expenses were lower due to reduced share-based compensation expense and professional service fees.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $2.0 million for the third quarter of 2018 compared to net loss before non-controlling interest of $9.6 million for the second quarter of 2018.
Net Loss Per Share: GAAP net loss per share was $0.06 and $0.31 for the three months ended September 30, 2018 and June 30, 2018, respectively, based on weighted-average shares of 12.3 million and 10.0 million for the three month periods ended September 30, 2018 and June 30, 2018, respectively. Non-GAAP net loss per fully exchanged share was $0.06 and $0.29 for the three months ended September 30, 2018 and June 30, 2018, respectively, based on non-GAAP fully exchanged weighted-average shares of 35.4 million and 33.1 million for the three months ended September 30, 2018 and June 30, 2018, respectively.

Mirati Therapeutics Announces First Patient Dosed In Phase 1b Clinical Trial Of Sitravatinib In Combination With Anti-PD1 Antibody Tislelizumab In Patients With Advanced Solid Tumors

On November 8, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported dosing of the first patient under its collaboration agreement with BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) in a Phase 1b clinical trial to assess the safety and tolerability, pharmacokinetics and preliminary anti-tumor activity of Mirati’s sitravatinib in combination with BeiGene’s investigational anti-PD1 antibody, tislelizumab, in patients with advanced solid tumors (Press release, Mirati, NOV 8, 2018, View Source [SID1234531086]). The clinical trial is currently enrolling patients in China and Australia.

"We’re excited to move into the next phase of our collaboration with BeiGene. BeiGene’s ability to rapidly enroll patients into this clinical trial has the potential to significantly expand and accelerate our development efforts for sitravatinib and provide access to additional patient populations," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati. "This clinical trial also has the potential to provide proof of concept clinical data in multiple solid tumor types."

This initial open-label, multicenter, non-randomized Phase 1b clinical trial is designed to assess the safety and tolerability in patients with histologically or cytologically confirmed locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC), renal cell carcinoma, and ovarian cancer. Patients will receive 120 mg of oral sitravatinib, daily, and 220 mg of intravenous tislelizumab, every three weeks.

"This collaboration has progressed quickly, and we are pleased that we can investigate the potential complementary activity of sitravatinib and tislelizumab in patients with advanced solid tumors in China and Australia," said Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.

Under the terms of the collaboration agreement, upon initiation of the clinical trial by BeiGene, Mirati will receive a $3 million milestone payment.

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial enrolling patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.

Keryx Biopharmaceuticals Announces Third Quarter 2018 Financial Results

On November 8, 2018 Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), a biopharmaceutical company focused on bringing innovative medicines to people with kidney disease, reported its financial results for the third quarter ended September 30, 2018 (Press release, Keryx Biopharmaceuticals, NOV 8, 2018, View Source [SID1234531085]). The company also reviewed its commercial progress with Auryxia and provided a general business update.

"We continued to see significant growth year-over-year in the number of prescriptions written and the revenue generated by Auryxia," said Jodie Morrison, interim chief executive officer of Keryx Biopharmaceuticals. "We are continuing to make progress on consummating our merger with Akebia and have scheduled a stockholder meeting to approve the transaction for December 11, 2018. We are excited about the potential strategic, financial and operational benefits of this transaction and are aiming, subject to stockholder approval and satisfaction of other customary conditions, to close the transaction by the end of the year."

Business Highlights

Net U.S. Auryxia product sales were $26.6 million in the third quarter of 2018, as compared to $13.6 million in the same quarter in 2017, representing growth of 96 percent.
Approximately 47,500 Auryxia prescriptions were reported in the third quarter of 2018, representing 9.4 million Auryxia tablets. This compares to approximately 25,200 prescriptions and 5.4 million Auryxia tablets in the third quarter of 2017.
Auryxia market share for the third quarter of 2018 was 6.4 percent, compared to 3.5 percent in the third quarter of 2017.
The breadth of physicians prescribing Auryxia continued to expand in the third quarter of 2018 compared to the same period in 2017, with approximately 6,500 prescribers in the 2018 quarter, nearly 2,000 more than the third quarter of 2017.
The depth of Auryxia prescribing also increased significantly in the third quarter of 2018, with a 28 percent increase in the average number of prescriptions per prescriber as compared to the third quarter of 2017.
As expected, there was a shift in channel mix for Auryxia during the third quarter of 2018, with 61 percent of prescriptions coming through IMS reporting channels and 39 percent coming through specialty pharmacies (including Fresenius Rx and Davita Rx); the shift in mix is due the closing of Davita’s specialty pharmacy business, which occurred in September 2018.
The gross-to-net adjustment for Auryxia for the third quarter of 2018 was 50 percent. This is consistent with year-to-date 2018 gross-to-net adjustment of 50 percent.
Akebia Merger Update

On June 28, 2018, Keryx announced that it had entered a definitive merger agreement with Akebia Therapeutics, Inc. that is expected to close by the end of 2018, subject to stockholder approvals and satisfaction of customary closing conditions.
If the merger is consummated, Keryx stockholders would continue to participate in the growth of Auryxia and gain access to an innovative Phase 3 product candidate with the potential to compete in a complementary multi-billion-dollar market, upon successful completion of its development program. The combined company would have substantial financial resources, an integrated platform for the development and launch of renal drugs and be led by a seasoned executive with decades of experience in the renal field.
The definitive proxy materials were filed with the Securities and Exchange Commission (SEC) on October 30, 2018 and the companies’ respective stockholder meetings are scheduled for December 11, 2018 for stockholders of record as of October 22, 2018.
The Keryx Board continues to unanimously support the merger and recommends that stockholders vote FOR the merger proposals at the upcoming stockholders’ meeting.
Given the pending merger with Akebia, Keryx will not be holding a conference call to discuss third quarter 2018 results.

Third Quarter Ended September 30, 2018 Financial Results

"I’m pleased to be reporting another solid quarter of Auryxia performance, having nearly doubled revenue over the same period a year ago, driven primarily by increases in volume," said Scott Holmes, senior vice president and chief financial officer of Keryx Biopharmaceuticals. "We believe the proposed merger with Akebia will put us in a strong position financially, with Akebia’s significant cash position today and Auryxia’s growing revenues contributing to the financial strength of the combined company in the future."

Total revenues for the quarter ended September 30, 2018 were $28.0 million, compared with $15.0 million during the same period in 2017. Total revenues for the third quarter of 2018 include $26.6 million in net U.S. Auryxia product sales, as compared to $13.6 million in the third quarter of 2017. Total revenues for the third quarter of 2018 also include $1.4 million in license revenue, as compared to $1.4 million during the same period in 2017.

Cost of goods sold for the quarter ended September 30, 2018 were $7.5 million, compared with $5.9 million during the same period in 2017.

Selling, general and administrative expenses for the quarter ended September 30, 2018 were $26.5 million, as compared to $22.7 million during the same period in 2017. Selling, general and administrative expenses for the quarter ended September 30, 2018 included $3.4 million in non-cash stock compensation expense, as compared to $2.9 million during the third quarter of 2017.

Research and development expenses for the quarter ended September 30, 2018 were $7.9 million, as compared to $9.3 million during the same period in 2017. Research and development expenses for the quarter ended September 30, 2018 included $0.4 million in non-cash stock compensation expense, as compared to $0.5 million during the same period in 2017.

Net loss for the quarter ended September 30, 2018 was $17.0 million, or $0.14 per share, as compared to a net loss of $23.5 million, or $0.20 per share, for the same period in 2017. Net loss for the quarter ended September 30, 2018 included $2.2 million in non-cash interest expense related to the amortization of a discount recognized in connection with the modification of the convertible senior notes.

Cash and cash equivalents as of September 30, 2018 totaled $41.1 million.

About Auryxia (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration (FDA) on September 5, 2014 for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis and approved by the FDA on November 6, 2017 for the treatment of iron deficiency anemia in patients with chronic kidney disease not on dialysis. Auryxia tablets were designed to contain 210 mg of ferric iron, equivalent to 1 gram of ferric citrate, and offers convenient mealtime dosing. The starting dose of Auryxia for the treatment of hyperphosphatemia for patients on dialysis is six tablets per day (two per meal) and for the treatment of iron deficiency anemia in patients not on dialysis is three tablets per day (one per meal). For more information about Auryxia and the U.S. full prescribing information, please visit www.Auryxia.com.

IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate)

CONTRAINDICATION

AURYXIA (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.

WARNINGS AND PRECAUTIONS

Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children.
ADVERSE REACTIONS

Most common adverse reactions with AURYXIA were:

Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%)
Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%)
SPECIFIC POPULATIONS

Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.

Akebia Therapeutics Announces Third Quarter 2018 Financial Results

On November 8, 2018 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported financial results for the third quarter ended September 30, 2018 (Press release, Akebia, NOV 8, 2018, View Source [SID1234531054]).

"In the third quarter, we continued to drive our vadadustat Phase 3 development program, while working diligently to close our proposed merger transaction with Keryx Biopharmaceuticals by the end of 2018. The combination is expected to create a fully-integrated kidney disease therapeutics company, with a strengthened financial profile, positioned to deliver substantial long-term value to shareholders," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "In addition, we look forward to the Phase 3 clinical trial readouts in Japan from our collaboration partner, Mitsubishi Tanabe Pharma Corporation, expected next year. This will be the first time Phase 3 data has been reported for our product candidate, vadadustat, which is an important milestone."

Third Quarter 2018 and Recent Corporate Highlights

Merger Integration Planning:

Following the definitive merger agreement with Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced June 28, 2018, Akebia has been actively engaged in integration planning and expects to close the transaction by the end of 2018;
The combination offers potential operating and product portfolio synergies and the opportunity to create significant value and accelerate the growth potential beyond what either company would achieve separately;
The combined company will have an expanded and highly complementary nephrology portfolio, with Auryxia (ferric citrate), a U.S. Food and Drug Administration (FDA)-approved product in two indications with significant growth opportunity, and vadadustat, an investigational late-stage hypoxia-inducible factor prolyl hydroxylase inhibitor, which has the potential to provide a new oral standard of care to patients with anemia due to chronic kidney disease (CKD);
The combined company will have an established renal development, manufacturing and commercial organization, positioning it as a partner of choice for the renal community and for companies developing renal products; and
The combined company plans to leverage its leadership’s extensive expertise in the commercial renal market with the goal of maximizing sales of Auryxia while driving launch momentum for vadadustat in the United States, subject to FDA approval.
Clinical Development:

Akebia continued to enroll subjects in its Phase 3 INNO2VATE program, with top-line results expected in the first quarter of 2020, subject to the accrual of major adverse cardiovascular events (MACE). U.S. enrollment in the Phase 3 INNO2VATE Conversion study completed last quarter, as announced in Akebia’s second quarter 2018 earnings press release;
Akebia continued to enroll subjects in its Phase 3 PRO2TECT program, with top-line results anticipated in mid-2020, subject to the accrual of MACE; and
Akebia received a recommendation from the Independent Data Monitoring Committee, which held another meeting in the quarter, for Akebia’s global Phase 3 PRO2TECT and INNO2VATE programs to continue without modification.
Other Business:

This past quarter, Akebia appointed Cynthia Smith to its Board of Directors. With more than 20 years of broad leadership experience within the healthcare industry, including serving as a Chief Commercial Officer, Cynthia brings expertise that is particularly relevant to Akebia as it prepares for the commercialization of vadadustat, subject to regulatory approval, and works to maximize the value of Auryxia, subject to the consummation of Akebia’s merger with Keryx Biopharmaceuticals.
Financial Results

Akebia reported a net loss of $26.0 million, or ($0.46) per share, for the third quarter of 2018 as compared to a net loss for the third quarter of 2017 of $23.1 million or ($0.49) per share.

Collaboration revenue was $53.2 million for the third quarter of 2018 compared to $41.3 million for the third quarter of 2017. Collaboration revenue recognized in the third quarter of 2018 related primarily to revenue recognized under both the U.S. collaboration agreement with Otsuka Pharmaceutical Co. Ltd., or Otsuka, and the collaboration agreement with Otsuka related to Europe, China and certain other regions, or the Otsuka International Agreement. Collaboration revenue recognized in the third quarter of 2017 also related to the Otsuka U.S. Agreement and the Otsuka International Agreement, which were consummated in December 2016 and April 2017, respectively.

Research and development expenses were $70.6 million for the third quarter of 2018 compared to $58.7 million for the third quarter of 2017. The increase was primarily attributable to external costs related to the global PRO2TECT and INNO2VATE Phase 3 programs. Research and development expenses were further increased by headcount and compensation-related costs.

General and administrative expenses were $10.4 million for the third quarter of 2018 compared to $6.7 million for the third quarter of 2017. The increase was primarily attributable to an increase in legal and other professional fees related to our proposed merger with Keryx Biopharmaceuticals, and an increase in costs to support the company’s research and development programs, including headcount and compensation-related costs.

Akebia ended the third quarter of 2018 with cash, cash equivalents and available for sale securities of $390.1 million. The company also generally receives cost-share funding from its collaboration agreements with Otsuka on a prepaid quarterly basis. Akebia expects its existing cash resources, including the prepaid quarterly committed cost-share funding from its collaborators, to fund its current operating plan through the first quarter of 2020.