|MannKind: ‘Early Launch Struggles Could Be Difficult to Overcome’; CEL-SCI Receives Authority on it'sPhase 3 Multikine Trial|
|By Marilyn Mullen|
|Monday, 11 May 2015 19:14|
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 11, 2015.
MannKind (NASDAQ: MNKD) to Underweight from Neutral, noting that “early launch struggles could be difficult to overcome.” Afrezza’s launch has been predictably slow out of the gate (1Q sales of ~$1.1M, incl stocking). What’s more troubling, however, are the apparent impediments to adoption.
Most notably, both partner Sanofi (SNY) and MannKind acknowledged that the pulmonary function testing (spirometry) required by the FDA has been a major hurdle, which is something we flagged as the key risk at the time of approval. We lived through the failed Exubera launch of 2007. While much of the focus then was on the device and odd dosing (two things Afrezza soundly addresses), we still believe the PFT requirement was the main obstacle to adoption (theoretic lung cancer risk was the final straw).
Other current impediments management cited include sampling issues and delay in getting doctor’s appointments. The bottom line is that we are increasingly skeptical that Rx will gain material traction anytime soon, which could put the balance sheet into an increasingly precarious position. Yet there’s still significant value reflected in the company’s diluted market cap of ~$1.8B. Accordingly, we are downgrading MannKind to Underweight from Neutral and withdrawing our $6 YE15 target.
Shares of MannKind have tumbled 7% to $3.55, while Sanofi has dropped 0.4% to $49.77
CEL-SCI Corporation (NYSE MKT:CVM) announced that Spain’s Agency for Medicinal Products and Medicinal Devices has authorized the Company to commence patient enrollment for its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer. Spain is the 22nd country to authorize CEL-SCI’s Phase 3 trial for patient enrollment.
CEL-SCI recently announced it had reached a key milestone of receiving authorization to conduct the Phase 3 study from 21 countries, as originally planned. The Company is aiming to expand the trial into a total of approximately 100 clinical centers in about 25 countries. As of April 30, 2015, 437 patients had been enrolled in the global Phase 3 study.
About the Multikine Phase 3 Study -- The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care (“SOC”) vs. subjects who are treated with SOC only.
About Multikine -- Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.
Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement (“CRADA”) with the U.S. Naval Medical Center, San Diego, as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.
Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces that it has received notification from the NASDAQ Listing Qualifications Department ("NASDAQ") that it is eligible for an additional 180 calendar days, until November 2, 2015, to regain compliance with the minimum $1.00 per share requirement for continued listing.
Achaogen, Inc. (Nasdaq:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, today reported an update of its Phase 3 plazomicin clinical programs as well as financial results for the quarter ended March 31, 2015.
Adaptimmune (Nasdaq:ADAP) today announced the closing of its initial public offering of 11,250,000 American Depositary Shares (ADSs) at a price to the public of $17.00 per ADS. The aggregate net proceeds to Adaptimmune, after underwriting discounts and commissions and estimated offering expenses, were approximately $175.7 million.
Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, will hold a conference call on Thursday, May 14, 2015, at 10:30 a.m. Eastern Time to discuss its results for the first quarter ended March 31, 2015.
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today that Joseph M. DeVivo, President and Chief Executive Officer, is scheduled to present at the UBS Global Healthcare Conference on Monday, May 18, 2015, at 1:30 p.m. ET.
Applied Genetic Technologies Corporation (Nasdaq:AGTC), a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced financial results for the third quarter ended March 31, 2015.
Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced that it is rescheduling the release of its first quarter financial results.
Growblox Sciences Inc. (OTCQB:GBLX), a biopharmaceutical research and development company with state-of-the-art technologies in plant biology and cultivation designed to produce consistent medicinal cannabis, announced today the launch of its new corporate website.
HealthEquity, Inc. (Nasdaq:HQY), one of the largest U.S. health savings account (HSA) non-bank custodians, today announced the closing of its previously announced follow-on public offering of an aggregate of 4,427,500 shares of common stock, including the 577,500 shares purchased pursuant to the full exercise of the underwriters' option to purchase additional shares, at a price to the public of $25.90 per share.
In a release issued under the same headline earlier today by Heat Biologics (Nasdaq:HTBX), please note that the first paragraph has been updated regarding the enrollment for the trial. The corrected release follows: Heat Biologics, Inc. (Nasdaq:HTBX), a clinical stage cancer immunotherapy company, announced today that it has initiated a new Phase 1b trial of Viagenpumatucel-L (HS-110) in non-small cell lung cancer ("NSCLC") and expects to enroll the first patient shortly.
Histogenics Corporation (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced the creation of its new Scientific Advisory Board (SAB) comprised of internationally renowned scientists and researchers.
Juno Therapeutics (Nasdaq:JUNO), a biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer, announced today that it has acquired Stage Cell Therapeutics GmbH, a privately held biotechnology company based in Munich and Göttingen, Germany.
Juno Therapeutics, Inc. (Nasdaq:JUNO), a biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer, today reported business highlights and financial results for the first quarter of 2015.
LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today announced that Christophe Lavigne, President and Chief Executive Officer, and Robert McNamara, Executive Vice President and Chief Financial Officer, will be presenting at the UBS Global Healthcare Conference to be held on May 18, 2015 to May 20, 2015 in New York.
Lombard Medical, Inc. (Nasdaq:EVAR), a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), today reported financial results for the first quarter ended March 31, 2015 and an operational update.
Macrocure Ltd. (Nasdaq:MCUR), a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today provided a corporate update and reported financial results for the first quarter ended March 31, 2015.
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, today reported financial and operating results for the first quarter ended March 31, 2015 and other recent developments.
NewLink Genetics Corporation (Nasdaq:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology medicines to patients with cancer, today announced the continuation without any modification or sample size adjustment for its pivotal, Phase 3 IMmunotherapy for Pancreatic RESectable cancer Study, called "IMPRESS," of algenpantucel-L for patients with surgically resected pancreatic cancer following the second planned interim data analysis.
Oncothyreon Inc. (Nasdaq:ONTY) today reported financial results for the first quarter ended March 31, 2015.
Phibro Animal Health Corporation (Nasdaq:PAHC) today announced its financial results for its third quarter ended March 31, 2015.
Premier, Inc. (Nasdaq:PINC) today reported financial results for the fiscal 2015 third quarter ended March 31, 2015.
Precision Optics Corporation, Inc. (OTCQB:PEYE) today announced that it intends to release its financial results for the fiscal 2015 third quarter ended March 31, 2015 after market trading ends on Thursday, May 14, 2015.
RestorGenex Corporation (OTCQB:RESX), a specialty biopharmaceutical company focused on developing products for oncology, ophthalmology and dermatology, today reported its financial results and cash balance for the first quarter ended March 31, 2015.
Surgical Care Affiliates, Inc. (Nasdaq:SCAI) announced today results for the first quarter of 2015, including: 21.5% growth in net operating revenues (to $234.1 million), 32.0% growth in operating income (to $48.8 million), 10.8% growth in adjusted EBITDA less NCI (to $35.9 million), and a net loss attributable to SCA of $9.2 million, driven by $15.6 million of one-time expenses related to a secondary stock offering and a debt refinancing completed in the first quarter.
TRACON Pharmaceuticals (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, age-related macular degeneration and fibrotic diseases, announced today that Charles Theuer, M.D, Ph.D., President and CEO, will present at the UBS Global Healthcare Conference at 3:00 pm EDT on Monday, May 18, 2015, at the Sheraton New York Times Square Hotel in New York, NY.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today reported its financial results and corporate update for the first quarter ended March 31, 2015.
Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, provided a corporate update, and announced financial results for the first quarter ended March 31, 2015.