BioShares Biotechnology Clinical Trials (BBC): $22.25, +$0.05

BioShares Biotechnology Products (BBP): $37.22, +$0.03

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed as investors remained on the sidelines in the face of political turmoil and fresh doubts about the health of economy. The dollar recorded broad losses following the allegations that U.S. President Donald Trump disclosed highly classified information to Russia’s foreign minister about a planned Islamic State operation. The day’s economic calendar carries data on housing starts, building permits and manufacturing output. After posting weak quarterly results, banking and pharma stocks weighed on European markets, while Vodafone’s well-received outlook helped Britain’s FTSE 100 to trade higher. Asian stocks witnessed a mixed trading day. Oil prices rose on expectations of an extended period of supply curbs and gold traded higher on reduced risk appetite.

 

 

MARKET HIGHLIGHTS

 

Altimmune announced the promotion of Sybil Tasker, M.D., FACP, FIDSA, to the position of Chief Medical Officer.  Dr. Tasker joined the company in April 2016 as Senior Vice President, Clinical Research and Development, with responsibility for overseeing Altimmune’s clinical research and development programs.  Before joining Altimmune, Dr. Tasker was Senior Director of Clinical Development at Genocea Biosciences where she led the GEN-003 therapeutic vaccine program.  Previously, Dr. Tasker had positions of increasing responsibility in infectious-disease product development strategy at two global CROs and was the senior U.S. Navy physician and technical advisor to the Department of Defense on a wide variety of infectious-disease policy issues, including HIV, tropical disease, vaccination, infection control, bioterrorism and pandemic preparedness. 

 

Albireo Pharma announced that the United States Patent and Trademark Office (USPTO) has allowed U.S. Patent Application No. 15/276,446, “IBAT inhibitors for the treatment of liver diseases” (‘446 patent). The ‘446 patent claims a method of treatment for Albireo’s lead product candidate A4250 in progressive familial intrahepatic cholestasis (PFIC) and other specified liver diseases. Upon issuance, the regular term of the ‘446 patent will expire in November 2031.

 

Palatin Technologies announced results for its third quarter ended March 31, 2017.  Palatin reported a net loss of $(3.6) million, or $(0.02) per basic and diluted share, for the quarter ended March 31, 2017, compared to a net loss of $(12.7) million, or $(0.08) per basic and diluted share, for the same period in 2016.  Palatin’s cash, cash equivalents and investments were $55.4 million as of March 31, 2017, compared to cash, cash equivalents and investments of $9.4 million at June 30, 2016.  Current liabilities were $17.4 million, net of deferred revenue of $53.8 million, as of March 31, 2017, compared to $13.9 million as of June 30, 2016.  Palatin believes that with the proceeds from our license agreement with AMAG, capital resources will be adequate to fund our planned operations through calendar year 2018.

 

Kamada announced financial results for the first quarter ended March 31, 2017.  Total revenues for the first quarter of 2017 of $11.6 million decreased by 21% as compared to $14.8 million in the first quarter of 2016.  Net loss for the first quarter of 2017 was $4.0 million, or loss of $0.11 per diluted share, compared to a net loss of $2.3 million, or loss of $0.06 per diluted share, in the same period of 2016.  As of March 31, 2017, the Company had cash, cash equivalents and short-term investments of $28.6 million, compared with $28.6 million as of December 31, 2016.

 

BrainStorm Cell Therapeutics has begun training the cell manufacturing team at City of Hope’s Center for Biomedicine and Genetics to produce clinical supplies of NurOwn® adult stem cells for the company’s randomized, double-blind, multi-dose Phase 3 clinical study in patients with Amyotrophic Lateral Sclerosis (ALS).  City of Hope will be the clinical supplier for all U.S. medical centers participating in the Phase 3 trial.

 

CTD Holdings will host a webinar to provide details of the Company’s recently initiated Phase I clinical trial in the U.S. and Phase I/II clinical trial in the EU, both evaluating CTD’s proprietary formulation of hydroxypropyl beta cyclodextrin, Trappsol® Cyclo™, for the treatment of Niemann-Pick Disease Type C (NPC). NPC is a rare and fatal genetic disease that damages the brain, lung, liver, spleen, and other organs. 

 

Santhera Pharmaceuticals announced that two posters with data from the positive phase III DELOS trial in patients with Duchenne muscular dystrophy (DMD) will be presented at the 113th American Thoracic Society (ATS) International Conference in Washington D.C.

 

Threshold Pharmaceuticals reported financial results for the first quarter ended March 31, 2017.  Net loss for the first quarter ended March 31, 2017 was $5.1 million compared to $7.9 million for the same period in 2016.  Cash, cash equivalents and marketable securities totaled $17.6 million at March 31, 2017 compared to $23.6 million at December 31, 2016.

 

Windtree Therapeutics reported financial results for the first quarter ended March 31, 2017.  The Company reported a net loss of $8.7 million for the quarter ended March 31, 2017, compared to a net loss of $13.9 million for the comparable period in 2016.  As of March 31, 2017, the Company had cash and cash equivalents of $8.0 million.

 

Pernix Therapeutics Holdings announced financial results for the three months ended March 31, 2017.  Net loss was $29.5 million for the first quarter of 2017, compared to $25.9 million in the first quarter of 2016.  As of March 31, 2017, the Company had $22.7 million of cash.

 

BioDelivery Sciences International reported financial results for the first quarter ended March 31, 2017.  Net revenue for the first quarter ended March 31, 2017, was approximately $29.5 million.  Net income for the first quarter ended March 31, 2017 was $48.3 million, or $0.89 per basic and $0.87 per diluted share, compared to a net loss of $18.7 million, or ($0.36) per basic and diluted share, in the same period of 2016. BDSI had cash and cash equivalents of approximately $35.2 million at March 31, 2017, including net proceeds of $13.7 million from the initial funding under the CRG facility in February 2017.  This compares to cash and cash equivalents of approximately $32.0 million at December 31, 2016.

 

LifeSci Advisors announced that Paul Yook, General Partner, LifeSci Venture Partners, will moderate the opening panel at MedCity INVEST, taking place this year from May 17–18, in Chicago, IL. “What’s Hot in Biopharma Investing?” will run from 9am–10am Central Time on Wednesday, May 17.

 

OSE Immunotherapeutics announced today that the Company presented in oral session significant data on Selective Anti-SIRPa OSE-172 (Effi-DEM), at the “2nd Annual Advances in Immuno-Oncology Congress” in London on May 15, 2017.

 

Inventiva announced results of a 12 month non-human primate toxicology study with its lead drug candidate IVA337, a pan PPAR agonist in phase IIb clinical development in non-alcoholic steato-hepatitis (NASH) and systemic sclerosis (SSc). No adverse clinical signs were observed during the treatment period at any dose-level and none of the typical adverse effects related to the thiazolidinones were observed.

 

BIOPHYTIS announced the issuance of 300 Bonds Redeemable in Cash or New or Existing Shares, for a total amount €3 million, simultaneously with the issuance of 225,225 share subscription warrants.

 

Akebia Therapeutics and Vifor Pharma Group announced they have entered into an exclusive license agreement to sell vadadustat to Fresenius Medical Care dialysis clinics in the U.S upon approval by the FDA. Vifor Pharma will also make a $50 million equity investment in Akebia at $14 per share. Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in Phase III development for the treatment of anemia associated with chronic kidney disease (CKD).

 

Sangamo Therapeutics announced that the FDA has granted Fast Track designation to SB-525, the Company’s clinical stage cDNA gene therapy candidate for hemophilia A, which is being developed as part of an exclusive, global collaboration and license agreement with Pfizer. The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics to treat serious conditions and fill an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication with the FDA is encouraged throughout the development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

 

Lannett announced that it received approval from the FDA of its ANDA for Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL (0.5 mg/mL), the therapeutic equivalent to the reference listed drug, Xyzal Oral Solution, 2.5 mg/5 mL (0.5 mg/mL), of UCB Inc.

 

Adaptimmune Therapeutics announced that it has initiated the first site for its MAGE‑A4 SPEAR T-cell study in patients with multiple malignant solid tumors. This study is now open for enrollment.

 

CRISPR Therapeutics announced that Target ALS Foundation, a non-profit organization dedicated to accelerating new treatments for amyotrophic lateral sclerosis (ALS), has awarded a two-year grant to CRISPR Therapeutics and its collaborators to support preclinical discovery and validation of CRISPR/Cas9-based therapeutic approaches directed to amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). CRISPR Therapeutics will collaborate with Dr. Laura Ranum and Dr. Eric Wang, researchers at the University of Florida in the Center for NeuroGenetics and the Department of Molecular Genetics & Microbiology, to test CRISPR/Cas9 gene-editing strategies in disease models developed by Dr. Ranum and Dr. Wang. The CRISPR Therapeutics and University of Florida consortium was one of four awardees selected by the independent scientific review committee out of a large field of highly competitive applications.

 

Propanc Biopharma announced the company awaits a response from the FDA to an Orphan Drug Designation (ODD) request for the use of its lead product, PRP, a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Submitted in February 2017, the proposed orphan drug indication for PRP is the treatment of pancreatic cancer, one of the most lethal malignancies with a median survival of 6 months and a 5-year survival rate of less than 5%. The lethal nature of this disease stems from its propensity to rapidly disseminate to the lymphatic system and distant organs, and is a major unmet medical issue.

 

The Rady Children’s Institute for Genomic Medicine and Alexion Pharmaceuticalsannounced a strategic partnership to accelerate the diagnosis of critically-ill newborns with rare genetic disorders. The collaboration combines the Institute’s genomic research expertise with Alexion data science and bioinformatics capabilities to advance precision medicine for infants in an intensive care setting.

 

Synlogic has entered into a definitive merger agreement with Mirna Therapeuticsunder which Synlogic will merge with a wholly owned subsidiary of Mirna in an all-stock transaction. The merged company will continue under the Synlogic name and will focus on advancing Synlogic’s drug discovery and development platform for Synthetic Biotic medicines, which are designed using synthetic biology to genetically reprogram beneficial microbes to treat metabolic and inflammatory diseases and cancer. Synlogic also recently closed a $42 million Series C preferred stock financing from leading biotechnology investors, including Aju IB Investment, Ally Bridge Group, Arctic Aurora LifeScience, CLI Ventures, Perceptive Advisors, Rock Springs Capital, and other undisclosed new investors. Existing investors, Atlas Venture, Deerfield, New Enterprise Associates (NEA), and OrbiMed also participated in the financing.

 

Cardiome Pharma announced a number of changes to its senior management team. Changes to the Management Team: Justin Renz joins Cardiome as its new Chief Financial Officer (CFO), Jennifer Archibald, Cardiome’s current CFO, has been appointed to the position of Chief Business Operations Officer, David Dean, Cardiome’s VP Business Development and Investor Relations, has been appointed to the position of Chief Business Development Officer, Hugues Sachot, Cardiome’s SVP Commercial, has been appointed to the position of Chief Commercial Officer.

 

Regen BioPharma stated that progress continues to be achieved by Regen in developing small molecule drugs that activate and inhibit NR2F6. The Company reports that ChemDiv, Regen’s medicinal chemistry partner, has currently identified three series of compounds which activate NR2F6. These compounds are further being refined to increase levels of modulation in the checkpoint. Regen is working towards small molecule therapies that can treat cancer as well as autoimmune disorders such as arthritis and lupus. These compounds have been identified from Regen’s patented screening methodology and unique chemical libraries. ChemDiv, Inc. is a fully integrated Target-to-Clinic Contract Research Organization headquartered in San Diego, CA.

 

Innovus Pharmaceuticals today the signing of an exclusive license and distribution agreement with Densmore Pharmaceutical International for the commercialization of Zestra in France and Belgium.

 

Pharming Group announced that it has completed a new US$100 million finance agreement with Orbimed Advisors. This has been used to redeem the Amortizing Convertible Bonds due 2017/2018, and to refinance the Company’s senior debt facility with Silicon Valley Bank and Kreos Capital, together with the associated prepayment fees and the legal and other costs of the transaction. The loan, initially structured as a bridge facility will be replaced within 60 days by a full loan agreement with a maturity date of June 2021 under similar terms and conditions as described below.

 

Bellicum Pharmaceuticals announced that Annemarie Moseley, Ph.D., M.D., the Company’s Chief Operating Officer and Executive Vice President of Clinical Development, has announced her intention to leave the organization, effective July 31, 2017. Dr. Moseley will transition her responsibilities over this period and will remain a consultant to Bellicum through January 2019. The Company has initiated a search for a Chief Medical Officer.

 

MabVax Therapeutics Holdings announced the pricing of its public offering. The offering consists of 1,342,858 shares of the Company’s common stock, and an aggregate of 1,000,000 shares of 0% Series G Convertible Preferred Stock at a public offering price of $1.75 per share of Common Stock and Series G Preferred Stock. The Series G Preferred Stock will be sold to certain existing investors in the offering who, as a result of their purchases of common stock, would hold in excess of 4.99% of our issued and outstanding Common Stock, and elect to receive shares of our Series G Preferred Stock and is initially convertible into 1,000,000 shares of Common Stock, subject to adjustment for stock splits, stock dividends, recapitalizations, combinations, subdivisions or other similar events. The Series G Preferred Stock will not be separately listed on any securities exchange or other trading market. The Company has granted the underwriters an option for a period of up to 45 days from the date of the Company’s prospectus to purchase up to an aggregate of 201,428 additional shares of its common stock at the public offering price of $1.75 per share, less the underwriting discount, solely to cover overallotments. The offering is expected to close on May 19, 2017, subject to the satisfaction of customary closing conditions. The total expected gross proceeds of the public offering are $4.1 million before the underwriter’s discount and expenses. The net proceeds from this offering will be used towards funding three Phase I clinical trials for the Company’s antibody therapeutic, diagnostic, and radioimmunotherapy candidates; follow-on antibody development programs; and for working capital and general corporate purposes. Laidlaw & Company is acting as the sole book-running manager for this offering.

 

Insys Therapeutics announced that Darryl S. Baker, the Company’s CFO, will transition from the role of CFO when a successor is hired.

 

AVEO Oncology announced the appointment of Matthew Dallas as chief financial officer, effective June 1, 2017. In this role, Mr. Dallas will be responsible for the Company’s financial strategy and management as it takes steps toward the potential commercialization of tivozanib. Mr. Dallas will also serve on the executive leadership team which governs corporate strategy at AVEO. He succeeds Keith Ehrlich, the Company’s current chief financial officer, whose retirement from the Company was previously announced.

 

 

ANALYST RECOMMENDATIONS

 

Maxim analyst Jason McCarthy downgraded Mateon Therapeutics to “hold” from “buy,” citing the company’s decision to seek to raise capital months ahead of the interim FOCUS data in August suggests the offering will likely be highly structured and dilutive.

 

Citi analyst Joel Beatty downgraded NantKwest to “sell” from “buy” and decreased his price target to $3 from $4, citing the company has a history of significantly missing its clinical trial timelines, and there are no expectations for this to change over the near-term.

 

Jefferies analyst David Windley downgraded Patheon to “hold” from “buy” and increased his price target to $35 from $32, citing tender offer from Thermo Fisher. 

 

HC Wainwright analyst Ed Arce increased his price target of Akebia Therapeutics to $25 from $21, citing Akebia announced a partnership with Vifor Pharma Group, formerly Galenica Group, to provide vadadustat to Fresenius Medical Care, the largest kidney dialysis provider in the U.S., as its exclusive HIF-based therapy for the treatment of CKD-associated anemia across its U.S. dialysis clinics.

 

Following the topline results from the Ionis program demonstrated that depletion of TTR is an effective treatment for FAP, which directly validates the Alnylam patisiran program, Credit Suisse analyst Alethia Young increased her price target of Alnylam to $90 from $50; Leerink analyst Paul Matteis increased his price target of Alnylam to $67 from $53.

 

Leerink analyst Paul Matteis decreased his price target of Ionis to $45 from $47, citing GSK (MP)/IONS reported top-line results for TTRrx, which, while highly efficacious, highlighted several safety issues which is expected to put the IONS drug at a commercial disadvantage to ALNY’s patisiran.

 

Needham analyst Danielle Brill initiated coverage of the following companies: Sage Therapeutics with a “buy” rating and $82 price target; Alder Biopharmaceuticals with a “buy” rating and $36 price target.