1stOncology™: Cancer Intelligence Service – Page 15624 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Navidea Biopharmaceuticals Reports Second Quarter 2018 Financial Results

On August 8, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the second quarter of 2018 (Press release, Navidea Biopharmaceuticals, AUG 9, 2018, View Source [SID1234528788]). Navidea reported total revenues for the quarter of $542,000. Net loss attributable to common stockholders was $2.4 million.

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!

Michael Goldberg, M.D., President and Chief Executive Officer of Navidea BioPharmaceuticals, commented, "During the first half of the year, we continued to make significant progress executing on our strategy to develop imaging and therapeutics based on our activated macrophage targeting technology. We have generated additional clinical data with our imaging agents and progressed with our development efforts towards additional regulatory approvals. Macrophage Therapeutics is seeking to develop treatments for diseases where inflammation is a major contributing factor. Macrophage Therapeutics has an exclusive license from Navidea for all therapeutic uses of our propriety Manocept platform, while our diagnostics business is focused on the development and commercialization of precision imaging products for a large range of inflammatory related conditions. With the benefit of these corporate changes, we are well-positioned to create long-term value for our stakeholders as we focus the business and execute our mission of developing innovative immunodiagnostic agents and therapies that improve patient care."

Second Quarter 2018 Highlights and Subsequent Events

Signed exclusive license with Meilleur Technologies, Inc. ("Meilleur") a wholly-owned subsidiary of Cerveau Technologies, Inc. to conduct research using NAV4694, as well as an exclusive license for the development and commercialization of NAV4694 in Australia, Canada, China, and Singapore

Presented at the 8th Annual LD Micro Invitational Conference

Presented at the 2nd Annual NASH conference in Boston, MA

Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414 in March 2017 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

Total revenues for the second quarter of 2018 were $542,000 compared to $612,000 in the second quarter of 2017. Total revenues for the first six months of 2018 were $819,000 compared to $1.2 million for the same period in 2017. License revenue in 2018 was primarily related to the sublicense of NAV4694 to Meilleur; license revenue during 2017 was primarily related to the license of Tc99m tilmanocept to Sayre Therapeutics in India. Grant revenue in both 2018 and 2017 was primarily related to Small Business Innovation Research ("SBIR") grants from the National Institutes of Health ("NIH") supporting Manocept development.

Research and development ("R&D") expenses for the second quarter of 2018 were $1.1 million compared to $1.2 million in the second quarter of 2017. The net decrease was primarily due to reductions in drug project expenses related to NAV4694 and Manocept development costs, offset by increased therapeutics and Tc99m tilmanocept development costs. R&D expenses for the first six months of 2018 were $2.1 million compared to $1.9 million during the same period in 2017. The net increase was primarily due to net increases in drug project expenses related to NAV4694 and therapeutics development costs, offset by decreased Manocept and Tc99m tilmanocept development costs. The change in R&D expenses for both periods also included net decreased compensation related to decreased headcount.

Selling, general and administrative ("SG&A") expenses for the second quarter of 2018 were $1.8 million, compared to $4.2 million in the second quarter of 2017. SG&A expenses for the first six months of 2018 were $3.6 million, compared to $7.3 million during the same period in 2017. The net decrease for both periods was primarily due to decreased legal and professional services, a loss on disposal of assets related to our previous office space, termination costs related to the arbitration award to our former CEO, a loss on termination of our previous office lease, and decreased general office expenses such as depreciation, insurance and rent.

Navidea’s net loss attributable to common stockholders for the quarter ended June 30, 2018 was $2.4 million, or $0.02 per share (basic), compared to a net loss attributable to common stockholders of $5.2 million, or $0.03 per share, for the same period in 2017. Navidea’s net loss attributable to common stockholders for the six-month period ended June 30, 2018 was $9.1 million, or $0.06 per share (basic), compared to net income attributable to common stockholders of $80.4 million, or $0.50 per share, for the same period in 2017.

Navidea ended the second quarter of 2018 with $5.5 million in cash and investments, including the accelerated earnout payment of $6.0 million from Cardinal Health 414 which was received during the quarter.

Conference Call Details

Investors and the public are invited to access the live audio webcast through the link below. Participants who would like to ask questions during the question and answer session must participate by telephone. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins.

Event:

Second Quarter 2018 Earnings and Business Update Conference Call

Date:

Thursday, August 16, 2018

Time:

5:00 pm (Eastern Time)

U.S. & Canada Dial-in:

877-407-0312

Conference ID:

13682395

Webcast

View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

Corcept Therapeutics Announces Second Quarter 2018 Financial Results and Stock Repurchase Program; Provides Clinical Update

On August 9, 2018 Corcept Therapeutics Incorporated (NASDAQ: CORT), a company engaged in the discovery, development and commercialization of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its results for the quarter ended June 30, 2018 (Press release, Corcept Therapeutics, AUG 9, 2018, View Source [SID1234528784]).

Financial Highlights

Revenue of $62.3 million, a 75 percent increase from second quarter 2017 GAAP net income of $0.14 per share, compared to $0.10 per share in second quarter 2017 Non-GAAP net income of $0.20 per share, compared to $0.13 per share in second quarter 2017 Cash and investments of $159.9 million, a $19.6 million increase from first quarter 2018 2018 revenue guidance revised to $250 – 270 million, from $275 – 300 million Company announces $100 million stock repurchase program Relacorilant Data

The final 18 patients enrolled in the trial (the "High-Dose" cohort) receive 250 mg/day of relacorilant for four weeks, with dose being increased, as tolerability permits, to 300 mg/day for four weeks, then 350 mg/day for four weeks, then 400 mg/day for four weeks; data are available for the 250 mg/day and 300 mg/day dose levels.

Based on FDA feedback, Corcept has developed response criteria for relacorilant’s Phase 3 trial. Applying these endpoints to the High-Dose cohort at eight weeks of treatment (conclusion of the 300 mg dose level) produces the following results:

Fifty-eight percent of patients with hyperglycemia achieved improved glucose control, as shown by a
(i) 0.5 percent or greater reduction in HbA1c or (ii) 50 mg/dl or greater reduction (or normalization) in 2-hour glucose as measured in the oral glucose tolerance test or (iii) 25 percent or greater decrease in antidiabetic medications

Fifty-five percent of patients with uncontrolled hypertension achieved a five millimeter or greater drop in either systolic or diastolic blood pressure, as measured by 24-hour ambulatory monitoring No evidence of progesterone receptor affinity; no instances of hypokalemia Testing of higher doses is ongoing; Phase 3 trial planned to start this year Oncologic and Metabolic Disorders

Placebo-controlled, Phase 2 trial of relacorilant plus Abraxane (nab-paclitaxel) in metastatic ovarian cancer planned to start by year-end Results expected by year-end in study of relacorilant plus Abraxane in patients with metastatic pancreatic cancer Dosing continues in Phase 1/2 trial of CORT125281 plus Xtandi (enzalutamide) in patients with metastatic castration-resistant prostate cancer Planning underway for placebo-controlled, Phase 2 trials of CORT118335 in patients with antipsychotic-induced weight gain and non-alcoholic steatohepatitis ("NASH"); both trials planned to start by year-end Financial Results

Corcept reported quarterly revenue of $62.3 million, compared to $35.6 million in the second quarter of 2017. Second quarter GAAP net income was $18.2 million, compared to $12.6 million in the same period last year. Excluding non-cash expenses related to stock-based compensation, utilization of deferred tax assets, accreted interest on the company’s retired royalty financing obligation and related income tax effects, non-GAAP net income in the second quarter was $25.4 million, compared to $16.0 million in the second quarter of 2017. (A reconciliation of GAAP to non-GAAP net income is set forth below.) The company reduced its 2018 guidance to $250 – 270 million.

Second quarter operating expenses were $41.7 million, compared to $22.8 million in the second quarter of 2017, primarily due to increased spending to advance relacorilant, CORT118335 and CORT125281 and costs from increased sales volume.

Cash and investments were $159.9 million at June 30, 2018, an increase of $19.6 million from first quarter 2018.

The company announced a program to repurchase up to $100 million of its common stock, which it intends to fund using cash and investments. Details of the program are provided below.

"Our Cushing’s syndrome franchise continues its significant growth, driven by physicians’ increasing realization that hypercortisolism is a serious disorder and that cortisol modulation is the best medical therapy for many patients," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "We are confident this shift in medical practice will continue."

Relacorilant’s Phase 2 Trial

"Interim data from our Phase 2 trial’s High-Dose cohort showed that relacorilant provided clinically meaningful benefit without the two off-target effects – progesterone receptor affinity and increased cortisol levels – that cause Korlym’s most common and serious adverse events – termination of pregnancy, endometrial thickening, vaginal bleeding and low potassium (hypokalemia)," said Robert S. Fishman, MD, Corcept’s Chief Medical Officer.

"That relacorilant did not cause hypokalemia in these patients is surprising – and important," he added. "Forty-four percent of the patients in Korlym’s pivotal trial experienced hypokalemia, which can be life-threatening. It is one of the most common adverse events in patients taking Korlym today.

"Interim efficacy data have also been impressive. Based on our planned Phase 3 endpoints, 58 percent of the patients with hyperglycemia achieved improved glucose control. Applying the same endpoints, this figure was 48 percent at the comparable time in Korlym’s pivotal trial ("SEISMIC") and 23 percent at the conclusion of treatment in the Low-Dose cohort. (See Figure 1) For patients with hypertension, 55 percent responded in the High-Dose cohort, compared to 44 percent in SEISMIC and 45 percent of the Low-Dose cohort. (See Figure 2)

"Relacorilant was well-tolerated," he concluded. "We observed one serious adverse event, a pilonidal abscess, which resolved without discontinuing relacorilant. One patient discontinued due to musculoskeletal pain and fatigue – a relatively common adverse event seen as cortisol modulation decreases cortisol activity."

Oncology

"At ASCO (Free ASCO Whitepaper)’s annual meeting this May, we reported positive data from the dose-finding portion of our Phase 1/2 study of relacorilant plus Abraxane to treat patients with solid tumors," added Dr. Fishman. "At the minimum therapeutic dose, four of nine patients with metastatic pancreatic cancer and four of seven patients with metastatic ovarian cancer demonstrated durable disease control. These results are especially notable in patients with such dire disease, all of whom had progressed on one or more prior taxane-based treatments. Recently, another patient with pancreatic cancer has achieved a partial response.

"These results justify significantly expanding our oncology program. By year-end, we plan to open a placebo-controlled, Phase 2 trial of relacorilant plus Abraxane in metastatic ovarian cancer. We also expect to have enough data by year-end in patients with metastatic pancreatic cancer to determine if a definitive trial is warranted."

Conference Call

Corcept will hold a conference call August 9, 2018, at 5:00 pm Eastern Time (2:00 pm Pacific Time). To participate, dial 1-888-394-8218 from the United States or 1-323-794-2588 internationally ten minutes before the start of the call (passcode: 6703650). A replay will be available through August 23, 2018 at 888-203-1112 from the United States and 719-457-0820 internationally (passcode: 6703650).

Audentes Therapeutics to Present at the 2018 Wedbush PacGrow Healthcare Conference

On August 9, 2018 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported that Natalie Holles, President and Chief Operating Officer, will present at the 2018 Wedbush PacGrow Healthcare Conference in New York (Press release, Audentes Therapeutics, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363055 [SID1234528780]). The presentation is scheduled for Tuesday, August 14, 2018, at 1:55 pm ET.

To access a live webcast of the presentation, please visit the Events & Presentations page within the Investors + Media section of the Audentes website. A replay of the live webcast will be available on the Audentes website for approximately 30 days following the conference.

Abeona Therapeutics Reports Second Quarter 2018 Financial Results and Business Highlights

On August 9, 2018 Abeona Therapeutics Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, reported financial results for the second quarter of 2018 (Press release, Abeona Therapeutics, AUG 9, 2018, View Source [SID1234528779]). The Company will host a call to update investors on recent clinical developments and quarter financial results on Friday, August 10th at 10:00 am (Eastern). Interested parties are invited to participate in the call by dialing 877-407-9210 (toll-free domestic) or 201-689-8049 (International) or via webcast View Source

"The second quarter was marked by continued progress in our clinical, pre-clinical and corporate initiatives," stated Carsten Thiel, Ph.D., Abeona’s CEO. "The strength of our lead programs, which continue to demonstrate robust and durable clinical effects, is underscored by the achievement of additional regulatory designations and the recent appointment of key executives and Board members. Notably, the opening of our in-house GMP manufacturing facility in Cleveland reinforces Abeona’s ongoing commitment to transforming patients’ lives and bolsters our position for commercial readiness."

2nd Quarter Summary Financial Results:

·Cash position: Cash, cash equivalents and marketable securities as of June 30, 2018 were $120 million, compared to $132 million as of March 31, 2018.
·Revenues: Revenues were $819 thousand for the second quarter of 2018, compared to $217 thousand in the second quarter of 2017. A portion of the increased quarterly revenues consisted of the recognition of Foundation grants that were announced during the fourth quarter of 2017. A portion of the grants were received in the second quarter of 2018, and the amount recognized is matched against corresponding expenditures for drug manufacture and clinical readiness. Additional revenues consisted of royalties from marketed products, primarily MuGard.
Loss per share: Loss per share was $0.25 for the second quarter of 2018, compared to a loss per share of $0.21 in the comparable period in 2017.

Abeona Recent Highlights:

July 26, 2018: Announced Leadership Appointments with Max Colao as Chief Commercial Officer
May 31, 2018: Announced Opening of Commercial Gene & Cell Therapy Manufacturing Facility in Ohio
May 18, 2018: Reported Update on MPS IIIA Gene Therapy Trial at the 21st Annual ASGCT (Free ASGCT Whitepaper) Meeting
ABO-102 18-month efficacy and safety data continue to demonstrate time- and dose-dependent reductions in underlying disease pathology, including decreased CSF and urine GAGs and improved liver volumes
11 subjects enrolled through > 4,200 days cumulative follow up
May 17, 2018: Reported Update from EB-101 Gene Therapy in Epidermolysis Bullosa at 21st Annual ASGCT (Free ASGCT Whitepaper) Meeting
Phase 1/2 study update results confirm EB-101 is safe and well-tolerated, with durable efficacy throughout various timepoints post-administration

Collagen VII (C7) expression: C7 and morphologically normal NC2 reactive anchoring fibrils were observed as early as one month in EB-101 treated wounds and have remained up to three years post-administration.
Wound healing, defined as >50% closure after EB-101 administration, was observed in:
100% (42/42 treated wounds, n=7 subjects) at 3 months;
90% (38/42 treated wounds, n=7 subjects) at 6 months;
67% (24/36 treated wounds, n=6 subjects) at 12 months;
88% (21/24 treated wounds, n=4 subjects) at 24 months; and
100% (6/6 treated wounds, n=1 subject) at 36 months post-administration.
May 14, 2018: Announced Appointment of Stefano Buono and Richard Van Duyne to its Board of Directors
April 23, 2018: Announced FDA Grants RMAT Designation to ABO-102 Gene Therapy in MPS IIIA
April 20, 2018: Announced EMA Grants Orphan Drug Designation in the European Union for ABO-202 Gene Therapy Program in Batten Disease
April 2, 2018: Announced Appointment of Carsten Thiel, Ph.D., as Chief Executive Officer

"As we advance towards becoming a key player in the development of novel breakthrough gene and cell therapies for rare genetic diseases, 2018 continues to be a year of execution for Abeona," stated Steven H. Rouhandeh, Abeona’s Executive Chairman

ChemoCentryx Reports Second Quarter 2018 Financial Results and Recent Highlights

On August 9, 2018 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the second quarter ended June 30, 2018 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, AUG 9, 2018, View Source [SID1234528752]).

"A most important milestone has recently been achieved at ChemoCentryx: we completed enrollment of over 300 patients in our landmark ADVOCATE Phase III trial in ANCA-associated vasculitis," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We’re targeting the fourth quarter of 2019 for the release of top-line data from ADVOCATE, and expect that successful trial results would form the basis of our new drug application to the FDA. Our very healthy balance sheet also enables us to simultaneously pursue other high unmet need, high value disease indications. Specifically, controlled clinical trials are underway for avacopan in C3G and for our other innovative kidney asset, CCX140 in FSGS. These are all orphan renal diseases with no approved therapies. Our plan to expand into orphan dermatological disease is also progressing extremely well. We intend to launch a large controlled clinical trial of avacopan in hidradenitis suppurativa later this year. In sum, 2018 is shaping up to be a watershed year for the Company, and we believe our momentum is building."

Recent Highlights

ChemoCentryx has completed enrollment of 316 patients in the Phase III ADVOCATE pivotal trial of avacopan for the treatment of ANCA-associated vasculitis. The trial will evaluate the safety and efficacy of avacopan following 52 weeks of treatment.

Expanded commercial alliance with Vifor Pharma to provide Vifor with commercialization rights in China for avacopan and CCX140, in exchange for upfront cash payments to ChemoCentryx totaling $21.5 million, plus tiered royalties between the teens and mid-twenties on potential net future sales in the Vifor territories.

Surpassed 45% of the patient enrollment target in the Company’s clinical trial evaluating avacopan for C3G. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant with relapsing disease common. There is no approved effective treatment.

Reported $91.5MM in cash receipts year-to-date; current balance sheet >$200MM in cash and equivalents.

Developed plan to launch clinical trials by the end of 2018 of avacopan in HS, an inflammatory and chronic skin disease characterized by recurrent, painful, boil-like nodules under the skin.

Launched clinical development of CCR2 inhibitor CCX140 in two sub-populations of primary FSGS, an orphan kidney disease with no approved treatment option.

Second Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled approximately $201.8 million at June 30, 2018. In the first six months of 2018, ChemoCentryx received $91.5 million in cash from milestone and upfront payments and credit facility advances. Cash utilized for the first six months of the year was $25MM. For the full year, the Company expects to utilize cash and investments between $60 million and $70 million.

Revenue was $15.0 million for the second quarter of 2018, compared to $8.9 million for the same period in 2017. Revenue recognized represents amortization of the upfront license fee commitments, milestone payments and collaboration funding from Vifor pursuant to the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement. The increase from 2017 to 2018 was primarily due to the Company’s adoption of Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers effective January 1, 2018.

Research and development expenses were $17.8 million for the second quarter of 2018, compared to $14.3 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to the patient enrollment of the avacopan Phase II clinical trial in patients with C3G and start-up expenses related to the CCX140 Phase II clinical trials in patients with FSGS.

General and administrative expenses were $4.7 million for the second quarter of 2018, compared to $4.2 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, partially offset by a decrease in professional fees.

Net loss for the second quarter of 2018 was $6.9 million, compared to $9.2 million for the same period in 2017.

Total shares outstanding at June 30, 2018 were approximately 50.3 million shares.

Conference Call and Webcast

The Company will host a conference call and webcast today, August 9, 2018 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 6238899. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.