BioShares Biotechnology Clinical Trials (BBC): $21.13, -$0.39, +14.8% YTD

BioShares Biotechnology Products (BBP): $36.60, -$0.57, +11.8% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were modestly higher, supported by historically low stock market volatility and continuing relief from this weekend’s French Presidential election. Walt Disney, Priceline and Nvidia are scheduled to report quarterly results later in the day. Wholesale inventories and JOLTS report on job openings are on the economic radar. A raft of well-received earnings and a recovery in resources stocks helped European markets to trade higher, while Asian shares recorded a mixed trading day. Oil prices rose on expectations that major oil-producing countries may extend supply cuts into 2018. Gold prices hit their lowest in nearly eight weeks as safe-haven demand ebbed on easing political worries after France’s presidential election.

 

 

MARKET HIGHLIGHTS

 

Aeglea BioTherapeutics reported financial results for the first quarter ended March 31, 2017.  At March 31, 2017, Aeglea had available cash, cash equivalents and marketable securities of $57.9 million. Based on Aeglea’s current operating plan, management believes that it has sufficient capital resources to fund anticipated operations through March 31, 2019.  Net loss totaled $6.2 million and $4.5 million for the first quarter of 2017 and 2016, respectively.

 

Aimmune Therapeutics announced financial results for first quarter 2017. Cash, cash equivalents, and investments totaled $259.3 million at March 31, 2017, compared to $282.5 million at December 31, 2016. The decrease primarily reflects cash used in operations.  Net loss was $25.9 million in the first quarter of 2017, compared to a net loss of $15.5 million for the comparable period in 2016. On a per share basis, net loss for the first quarter of 2017 was $0.52, compared to net loss per share of $0.37 for the comparable period in 2016.

 

Aimmune Therapeutics will present a company overview at the Bank of America Merrill Lynch Healthcare Conference in Las Vegas on Tuesday, May 16, at 1:00 p.m. Pacific Time.

 

Aurinia Pharmaceuticals announced the appointment of George M. Milne, Jr., Ph.D. to its board of directors. Prior to his retirement, Dr. Milne served as Executive Vice President of Global Research and Development and President of Worldwide Strategic and Operations Management at Pfizer. Dr. Milne serves on multiple corporate boards including Charles River Laboratories where he is the lead director and Amylyx Pharmaceuticals and is Venture Partner at Radius Ventures.

 

BioTime announced new data from the Phase I/IIa clinical trial of OpRegen® in the advanced form of dry age-related macular degeneration (dry-AMD). The interim data were presented on May 8, 2017 at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Baltimore, Maryland by Eyal Banin, M.D., Ph.D.

 

Sierra Oncology reported its financial results for the first quarter ended March 31, 2017.  Net loss was $11.1 million for the first quarter of 2017, compared with a net loss of $10.5 million for the first quarter of 2016.  Cash and cash equivalents totaled $125.0 million as of March 31, 2017, compared to $109.0 million as of December 31, 2016. This increase was due to an underwritten public offering of 21,847,636 shares of common stock in February 2017, pursuant to which the company raised net proceeds of $27.4 million, net of underwriting discounts, commissions and offering expenses. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2019.

 

Gemphire Therapeutics announced financial results for the first quarter ended March 31, 2017.  Net loss attributable to common stockholders for the three months ended March 31, 2017 was $7.5 million or ($0.79) per basic and diluted share, compared to $2.3 million, or ($0.65) per basic and diluted share in the same period of 2016.  Cash and cash equivalents at March 31, 2017 totaled $29.3 million compared to $24.0 million at December 31, 2016.  On March 15, 2017, the Company closed its previously announced private placement and received gross proceeds of approximately $12.5 million.

 

Addex Therapeutics announced positive results from multiple preclinical studies of ADX71441, a positive allosteric modulator (PAM) of the gamma-aminobutyric acid subtype B (GABAB) receptor, in models of visceral hyperalgesia. The studies were led by Prof. Jyoti N. Sengupta at the Medical College of Wisconsin, with the support of a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a division of the US National Institute of Health. The findings strongly support the potential of ADX71441 in treating hyperalgesia in colonic inflammation (colitis) and bladder inflammation (cystitis). Chronic visceral pain syndromes related to the gastrointestinal or urinary tract represent an important unmet medical need as they can significantly impact the patient`s quality of life.

 

Santhera Pharmaceuticals announced approval by the Scottish Medicines Consortium for restricted use of Raxone® (idebenone) in patients with LHON, with effect May 8, 2017.  Patients with Leber`s hereditary optic neuropathy (LHON), an extremely rare, inherited cause of blindness, could benefit from the only licensed treatment to date, following advice issued by the Scottish Medicines Consortium (SMC) under the ultra-orphan medicine process. The SMC accepted Raxone® (idebenone) for restricted use by NHS Scotland in the treatment of visual impairment in adolescent and adult patients with LHON who are not yet blind (i.e., they do not meet the UK criteria to be registered as severely sight impaired). Raxone was accepted following consideration through SMC`s Patient and Clinician Engagement (PACE) process, for medicines used at the end of life and for very rare conditions. Scotland is the first country in the UK to make Raxone available for the treatment of LHON. The SMC advice takes into account the benefits of a Patient Access Scheme (PAS), which improves the cost-effectiveness of Raxone.

 

Mateon Therapeutics reported financial results for the three months ended March 31, 2017.  For the three months ended March 31, 2017, Mateon reported a net loss of $4.0 million, compared to a net loss of $3.3 million for the three months ended March 31, 2016.  At March 31, 2017, Mateon had cash and short-term investments of $8.3 million.

 

Achaogen reported financial results for the first quarter 2017.  Net loss for the first quarter of 2017 was $33.3 million, or $0.93 per share, compared to a net loss of $12.2 million, or $0.66 per share, for the first quarter of 2016.  Unrestricted cash, cash equivalents and short-term investments totaled $132.0 million at March 31, 2017 compared to $145.9 million at December 31, 2016.

 

Ohr Pharmaceutical will report financial results for its second fiscal quarter ended March 31, 2017 after the market close on Thursday, May 11, 2017. 

 

Rockwell Medical released several statements of support from shareholders in connection with the Company’s upcoming 2017 Annual Meeting of Shareholders (“Annual Meeting”) to be held on June 1, 2017.

 

Pernix Therapeutics Holdings will report financial results for the first quarter ended March 31, 2017, after the market close on Monday, May 15, 2017. 

 

Oramed Pharmaceuticals announced today that the Canadian Intellectual Property Office has granted Oramed a patent titled, "Methods and Compositions for Oral Administration of Exenatide". The patent covers Oramed’s invention of an oral glucagon-like peptide-1 (GLP-1) analog.

 

BioDelivery Sciences International will report its first quarter 2017 financial results and host a conference call and webcast at 4:30 PM Eastern Time on Monday, May 15, 2017.

 

Reuters reported that Valeant Pharmaceuticals International reported its first profit in six quarters, helped by a one-time tax gain, and raised its full-year earnings forecast. The company said it now expects 2017 adjusted earnings before interest, tax, depreciation and amortization (EBITDA) of $3.60-$3.75 billion, up from its previous forecast of $3.55-$3.70 billion. Net income attributable to Valeant was $628 million, or $1.79 per share, in the first quarter ended March 31, compared with a loss of $374 million, or $1.08 per share, a year ago. The latest results included a one-time income tax benefit of $908 million related to an internal restructuring. The company said its adjusted net income was $273 million. On a per share basis, Valeant’s earnings were 78 cents per share, below the average estimate of 82 cents, according to Thomson Reuters I/B//E/S. Revenue fell to $2.11 billion from $2.37 billion, missing the average estimate of $2.18 billion.

 

Valeant Pharmaceuticals International‘s wholly owned subsidiary, Bausch + Lomb, announced that the FDA accepted the NDA for brimonidine tartrate ophthalmic solution, 0.025% (Luminesse), and set a PDUFA action date of December 27, 2017.

 

Ionis reported 1Q17 GAAP EPS of $0.03, which compares to a loss of $0.52 for the same period a year ago. The company missed the GAAP EPS mean estimate of $0.04. Total revenue for 1Q17 was $110.3 million, which compares to $36.9 million for the same period a year ago. This compares to a mean estimate of $116.9 million.

 

Endo International reported 1Q17 non-GAAP EPS of $1.23, which compares to $1.08 for the same period a year ago. The company beat the non-GAAP EPS mean estimate of $1.10. Total revenue for 1Q17 was $1.04 billion, which compares to $963.54 million for the same period a year ago. This compares to a mean estimate of $1.02 billion.

 

Reuters reported that Allergan reported a higher-than-expected quarterly profit, and raised its 2017 revenue forecast to reflect its $2.48 billion acquisition of Zeltiq Aesthetics. Excluding items, Allergan earned $3.35 per share, beating the average analyst estimate by 5 cents, according to Thomson Reuters I/B/E/S.The company also raised its net revenue forecast to $15.8 billion-$16 billion, from $15.5 billion-$15.8 billion. Net loss attributable to ordinary shareholders was $2.63 billion, or $7.86 per share, in the first quarter ended March 31, compared with a profit of $186.1 million, or 47 cents per share, a year earlier. Net revenue rose about 5 percent to $3.57 billion, just ahead of the average analyst estimate of $3.54 billion.

 

After yesterday’s close, Portola Pharmaceuticals reported 1Q17 GAAP EPS loss of $0.74, which compares to a loss of $1.15 for the same period a year ago. The company beat the GAAP EPS mean estimate loss of $1.20. Total revenue for 1Q17 was $5.1 million, which compares to $8.3 million for the same period a year ago. This compares to a mean estimate of $20.5 million.

 

Auris Medical Holding announced key results from AMPACT1 (AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1), the open-label extension study of the Phase III TACTT2 clinical trial. The study provides additional confirmation on the long-term safety of Keyzilen and suggests the potential for further therapeutic benefits from repeated treatment.

 

Recro Pharma announced successful top-line results from its Phase III safety study evaluating intravenous (IV) meloxicam (30mg bolus injection) following major surgery. The primary objective of the study was to evaluate the safety and tolerability of IV meloxicam 30mg vs. placebo through Day 28 following treatment.  The study demonstrated that the adverse event profile of IV meloxicam 30mg was consistent with previously completed studies, and was similar to placebo.  Recro Pharma believes the results of this 722 patient Phase III safety study support the safety profile of IV meloxicam 30mg and completes the last clinical requirement of the full efficacy and safety program for a NDA for IV meloxicam 30mg as a novel, non-opioid for management of moderate to severe pain.

 

Protalix BioTherapeutics announced that the FDA cleared an IND for a clinical trial evaluating the safety and efficacy of administering 2 mg/kg of pegunigalsidase alfa (PRX-102) once monthly in Fabry patients.  The current dosing regimen for approved enzyme replacement therapies for Fabry disease is once every two weeks.  Pegunigalsidase alfa is a PEGylated, chemically-modified version of the recombinant alpha-Galactosidase-A enzyme, in which the protein sub-units are covalently bound via chemical cross-linking using PEG chains, resulting in a longer active and stable molecule compared to currently available enzyme replacement therapies (ERTs).

 

Soligenix announced that it has been granted a Japanese patent (number 6110845) further extending protection around ThermoVax including coverage of the Company’s ricin toxin vaccine candidate, RiVax. ThermoVax is a proprietary vaccine heat stabilization platform technology and the patent, entitled "Thermostable vaccine compositions and methods of preparing same," is also being pursued in other major markets worldwide, such as China, Europe, and the US.

 

NantCell and NantKwest announced that the FDA has authorized an IND Application for the NANT Cancer Vaccine for clinical trial enrollment for pancreatic cancer patients (ClinicalTrials.gov NCT03136406.

 

Researchers at the Casey Eye Institute, the Retina Foundation of the Southwest, the Kellogg Eye Center and Applied Genetic Technologies reported results from a study of the natural history of X-linked retinoschisis (XLRS) and the impact of carbonic anhydrase inhibitors (CAIs) on disease progression. The data were presented this week at ARVO 2017, the Association for Research in Vision and Ophthalmology Annual Meeting, taking place in Baltimore from May 7-11.

 

Alnylam Pharmaceuticals announced the appointment of several experienced industry leaders to key leadership roles including: Manmeet S. Soni, Chief Financial Officer; Theresa Heggie, Senior Vice President, Head of Europe and Canada; Peter Smith, Ph.D., Senior Vice President, Early Development; and Alan Eisenberg, Vice President, Global Public Policy and Government Relations.

 

Abeona Therapeutics announced Australian regulatory approval to initiate a Phase I/II for the ABO-102 gene therapy program for patients with Sanfilippo syndrome type A (MPS IIIA).  The clinical study was approved by the Australian Government Department of Health Therapeutic Goods Administration and the Company is conducting the Phase I/II clinical study at Adelaide Women’s and Children’s Hospital, Australia.

 

Cerus announced that additional options totaling $46.6 million have been exercised under its contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.

 

Corvus Pharmaceuticals announced that it has licensed global rights to an undisclosed novel immuno-oncology program, which includes a lead product candidate, from Monash University.

 

International Stem Cell announced that that the Data Safety Monitoring Board (DSMB), a group of experts monitoring the clinical trial of ISC-hpNSC neural cells, has reviewed the safety data from the first cohort in the  clinical trial. The DSMB has authorized the clinical trial to move forward with accelerated enrollment and dose escalation to the second cohort. Recruitment for the second cohort will begin immediately, with patients receiving a higher dose of 50,000,000 of ISC-hpNSC.

 

Novartis announced that the FDA has approved the Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women. The Kisqali Femara Co-Pack is the first, and only currently available, combination pack with two prescription products in advanced breast cancer. With this FDA approval, physicians in the U.S now have the flexibility to prescribe Kisqali two different ways: via the new Co-Pack or as two separate prescriptions of Kisqali and any aromatase inhibitor.

 

Cytokinetics announced plans to offer, subject to market and other conditions, $75,000,000 of its common stock in an underwritten public offering. There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. The company expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering. Morgan Stanley is acting as sole underwriter for the offering.

 

 

ANALYST RECOMMENDATIONS

 

Following TherapeuticsMD’s announcement they had received a CRL for TX-004HR, Oppenheimer analyst Jay Olson downgraded the stock to “perform” from “outperform;” Jefferies analyst Matthew Andrews decreased his price target to $15 from $18.

 

Credit Suisse analyst Alethia Young decreased her price target of Incyte to $152 from $167 due to moving from M&A base case valuation.

 

Citi analyst Joel Beatty decreased his price target of Novavax to $0.90 from $1.50, citing decreased net cash, an increased share count (due to ATM stock sale in Q1), and increased opex that considers guidance and a lack of update on enrollment in the Phase III maternal RSV vaccine trial that leaves open that possibility that the trial is behind schedule.

 

Citi analyst Yigal Nochomovitz increased his price target of Reata to $39 from $32, citing increased market size for PAH. 

 

Following Kite Pharma’s earnings, Wedbush analyst David Nierengarten downgraded the stock to “underperform” from “neutral” and decreased his price target to $54 from $60.

 

Evercore analyst Jonathan Miller initiated coverage of Tocagen with an “outperform” rating and $28 price target, citing the lead program is a combination of a tumor-targeting virus (Toca 511) and a follow-up oral therapy.

 

Needham analyst Alan Carr downgraded Scynexis to “hold” from “buy,” citing reduced visibility around SCY-078 development following yesterday’s update on FDA meeting.

Following Bellicum’s earnings, Guggenheim analyst Tony Butler decreased his price target to $26 from $38.

 

Following Horizon’s earnings, Mizuho analyst Irina Koffler decreased her price target to $10 from $22; Jefferies analyst David Steinberg decreased his price target to $14 from $26; BMO analyst Gary Nachman decreased his price target to $17 from $24; Stifelanalyst Annabel Samimy decrease her price target to $20 from $35.

 

Leerink analyst Geoffrey Porges decreased his price target of Acceleron to $54 from $55, citing higher R&D expenses in future periods.