BioShares Biotechnology Clinical Trials (BBC): $23.68, +$0.15, +28.6% YTD

BioShares Biotechnology Products (BBP): $37.98, -$0.28, +16.0% YTD

 

 

KOL Call Monday Morning: ACC 2017 Meeting Re-Cap

LifeSci Capital is hosting a Key Opinion Leader (KOL) Call with Dr. Michael Koren (Jacksonville Center for Clinical Research) to discuss the cardiovascular outcomes trial data for PCSK9 inhibitor drugs presented at the American College of Cardiology meeting. The call with include a discussion of recent trial data in addition to other abstracts and presentations from the conference.

 

Monday, March 20th @ 8am Eastern Time

Domestic:                    877-675-4749

International:               719-325-4802

Conference ID:            2022150

Webcast:                     public.viavid.com/player/index.php?id=123346

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed as investors kept an eye on the G20 finance leaders’ meeting in Germany this weekend, where topics including reforms to boost economic growth, protectionism and exchange rates are expected to be on the agenda. Industrial production, capacity utilization, manufacturing output and University of Michigan’s data are on the radar. Gold steadied, while the euro jumped to a five-week high against the dollar. European shares rose after an European Central Bank policymaker rekindled talk of a possible rate hike later this year, and Asian stocks ended higher. Oil prices rose.

 

 

MARKET HIGHLIGHTS

 

Threshold Pharmaceuticals and Molecular Templates jointly announced that they have entered into a definitive agreement under which Molecular Templates will merge with a wholly owned subsidiary of Threshold in an all-stock transaction. The transaction will result in a combined company focused on the development of novel treatments for cancer.  Longitude Capital, a U.S. based venture capital firm, will invest $20 million at the close of the transaction, subject to certain conditions, including the receipt of additional equity financing commitments of $20 million.  On a pro forma basis and based upon the number of shares of common stock to be issued in the merger, current Threshold shareholders would own approximately 34.4 percent of the combined company and current Molecular Templates shareholders would own approximately 65.6 percent of the combined company although the actual allocation will be subject to adjustment based on Threshold’s net cash balance. Eric Poma, Ph.D., Molecular Templates’ Chief Executive Officer, will become Chief Executive Officer of the combined company.  Following the Merger, the board of directors of the Company will consist of seven seats and will be comprised of two representatives of Molecular Templates; two representatives of the Company, and three representatives to be mutually agreed upon by Molecular Templates and the Company, with the Company’s current chairman of the board of directors, Barry Selick, Ph.D., continuing to act as chairman of the board of the Company following the Merger.  Upon closing of the transaction, Threshold will change its name to Molecular Templates, Inc. and plans to change its ticker symbol on the Nasdaq Capital Market to MTEM.

 

Aurinia Pharmaceuticals announced the AURION open-label study of voclosporin for the treatment of lupus nephritis (LN) 48-week results will be presented at the 12th International Congress on Systemic Lupus Erythematosus (LUPUS 2017) & the 7th Asian Congress on Autoimmunity (ACA 2017) taking place March 26-29, 2017 in Melbourne, Australia. The abstract, titled, “AURION Study: 48-Week Data of Multi-Target Therapy with Voclosporin, Mycophenolate Mofetil (MMF) and Steroids for Active Lupus Nephritis,” will be presented by Robert Huizinga, Aurinia Vice President of Clinical Affairs on March 27, 2017.

 

BioDelivery Sciences International reported financial results for the fourth quarter and full year ended December 31, 2016.  Total revenues for the year ended December 31, 2016, were $15.5 million, compared to $48.2 million in the same period of 2015.  Net loss for the year ended December 31, 2016, was $67.1 million, or ($1.25) per diluted share, compared to a net loss of $37.7 million, or ($0.72) per diluted share, in the same period of 2015.  BDSI had cash and cash equivalents of approximately $32.0 million at December 31, 2016. This compares to cash and cash equivalents of approximately $83.6 million at December 31, 2015.  Net proceeds from the initial funding under the CRG facility in February 2017 added cash of approximately $14 million to BDSI’s balance sheet.

 

BioTime reported financial results for the fourth quarter and year ended December 31, 2016.  Net loss attributable to BioTime was $5.1 million, or ($0.05) per basic and diluted common share for the three months ended December 31, 2016, compared to $13.4 million, or ($0.15) per basic and diluted common share due primarily to the deconsolidation of Asterias in May 2016. For 2016, net income attributable to BioTime was $33.6 million, or $0.35 per basic and $0.34 per diluted common share, compared to net loss attributable to BioTime of $47.4 million, or ($0.59) per basic and diluted common share. The 2016 net income attributable to BioTime was primarily due to the $49.0 million gain on deconsolidation of Asterias and the $34.4 million gain recognized from the increase in the market value of the Asterias shares owned by BioTime from May 13, 2016, the date of the deconsolidation, through the end of the year. Cash and cash equivalents totaled $22.1 million as of December 31, 2016, compared to $42.2 million as of December 31, 2015, which included Asterias’ cash and cash equivalents of $11.2 million. Based on the March 15, 2017 closing prices of Asterias and OncoCyte common stock owned by BioTime, the combined market value of these securities was $152 million on that date.

 

OncoSec Medical Incorporated announced financial results for the second quarter and year to date ended January 31, 2017.  For the second quarter of fiscal 2017 and the six months ended January 31, 2017, OncoSec reported a net loss of $5.4 million and $11.0 million, or $0.27 per share and $0.57 per share, respectively, compared to a net loss of $7.0 million and $14.1 million, or $0.42 per share and $0.89 per share, respectively, for the same periods last year.  At January 31, 2017, OncoSec had $20.5 million in cash and cash equivalents, as compared to $28.7 million of cash and cash equivalents at July 31, 2016. OncoSec expects these funds to be sufficient to allow it to continue to operate its business for at least the next 12 months.

 

Gemphire Therapeutics will provide a corporate update at the Oppenheimer 27th Annual Healthcare Conference on Tuesday, March 21st, and the 1st Annual H.C. Wainwright NASH Investor Event on Monday, April 3rd

 

CymaBay Therapeutics will host a conference call and live audio webcast on Thursday, March 23 at 4:30 p.m. Eastern Time to discuss fourth quarter and full year 2016 financial results and provide a business update.

 

Aeglea BioTherapeutics will report its financial results for the quarter and year ended December 31, 2016 on Thursday, March 23 after the market close, and will host a corporate update conference call and webcast at 4:30pm Eastern Time.

 

Reuters reported that Amgen‘s Repatha drug cut the risk of heart attacks and strokes by over 20 percent in patients with heart disease, demonstrating a clear clinical benefit beyond its ability to slash "bad" LDL cholesterol levels, data from a huge study known as Fourier showed. Results from the highly anticipated 27,564-patient Fourier study should help remove some barriers to patient access from health insurers and pharmacy benefit managers, who have been rejecting some 75 percent of prescriptions written for the costly medicine. Repatha cut the combined risk of heart attacks, strokes and heart-related death by 20 percent compared with a placebo in patients already on high doses of cholesterol-lowering statins, such as Lipitor. Most trial subjects had had a prior heart attack or stroke. Separately, Repatha cut heart attacks by 27 percent and stroke by 21 percent. In the second year of the study, the results were more pronounced, with a 35 percent reduction in heart attack risk and a 24 percent decrease in stroke risk.

 

Caladrius Biosciences has agreed to sell its remaining 80.1% ownership interest in its PCT, LLC subsidiary to Hitachi Chemical Co. America, Ltd. for $75 million in cash. Additionally, there is the potential for Caladrius to receive an additional cash payment of $5 million if PCT achieves a certain revenue-based milestone.

 

Galena Biopharma announced the final analysis from the Company’s GALE-301 (E39) investigator-sponsored Phase I/IIa clinical trial.  The data was given during an oral presentation by Dr. Larry Maxwell at the Annual Meeting on Women’s Cancer 2017 hosted by the Society of Gynecologic Oncology. The presentation was entitled, “Analysis of a Phase I/IIa Trial Assessing E39+GM-CSF, a Folate Binding Protein Vaccine, to Prevent Recurrence in Ovarian and Endometrial Cancer Patients.” GALE-301 is a cancer immunotherapy consisting of a peptide derived from Folate Binding Protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in ovarian and endometrial cancer patients in the adjuvant setting.

 

Boehringer Ingelheim and Eli Lilly announced that the EMPEROR HF clinical trial program was initiated. EMPEROR HF comprises two phase III outcome studies that will investigate empagliflozin for the treatment of adults with chronic heart failure. The trials will involve not only adults with Type II diabetes who have heart failure, but also heart failure patients who do not have diabetes.

 

Arbutus Biopharma announced it has licensed to Alexion Pharmaceuticals its proprietary lipid nanoparticle (LNP) technology for exclusive use in one of Alexion’s rare disease programs. This transaction enables Alexion to address delivery for therapeutic application of messenger RNA (mRNA) and rapidly enter clinical development with its mRNA product candidate. Under the terms of the license agreement, Alexion will pay Arbutus $7.5 million upfront, and payments of up to $75 million for achievement of development, regulatory, and commercial milestones, as well as single digit royalties. In addition, Arbutus will conduct technology development and provide manufacturing and regulatory support for the rapid advancement of Alexion’s mRNA product candidate.

 

AveXis reported topline results from the Phase 1 trial of AVXS-101 in spinal muscular atrophy (SMA) Type I. Following the news, Goldman analyst Salveen Richter increased her price target to $108 from $91; BMO analyst Ian Somaiya increased his price target $95 from $85; Jefferies analyst Biren Amin increased his price target to $92 from $79; Bank of America analyst Tazeen Ahmad increased her price target to $83 from $76.

 

Nordic Nanovector ASA announced that the first patient has been dosed in its Phase I study evaluating Betalutin (177Lu-satetraxetan-lilotomab), a novel CD37 targeting antibody-radionuclide conjugate, in patients with relapsed diffuse large B-cell lymphoma (DLBCL) – the "LYMRIT 37-05" trial.

 

BELLUS Health announced that it has entered into a share purchase agreement with Taro Pharmaceuticals for the sale of BELLUS Health’s wholly-owned subsidiary Thallion Pharmaceuticals, including all the rights to the drug candidate Shigamab. Pursuant to the Share Purchase Agreement, Taro is acquiring all issued and outstanding shares of Thallion for a potential total consideration of CA$2.7 million, consisting of an upfront payment of CA$2.3 million and a potential future payment of CA$0.4 million contingent upon the completion of a pre-established milestone event, expected to occur within 24 months of the closing of the transaction. In addition, BELLUS Health will receive a portion of certain post-approval revenues related to the Shigamab program.

 

Acura Pharmaceuticals and MainPointe Pharmaceuticals announced that they have entered into a License Agreement to have MainPointe exclusively market NEXAFED and NEXAFED Sinus in the US and Canada. The pseudoephedrine-containing NEXAFED brand products utilize Acura’s IMPEDE Technology which disrupts the extraction and conversion of the pseudoephedrine into the illicit drug, methamphetamine.  MainPointe will assume all manufacturing and commercialization activities from Acura.

 

Emergent BioSolutions announced that it has signed a two-year contract with the Biomedical Advanced Research and Development Authority (BARDA), a division within the Office of the Assistant Secretary of Preparedness and Response, valued at $100 million for the delivery of BioThrax (Anthrax Vaccine Adsorbed) to the Strategic National Stockpile (SNS). This contract satisfies BARDA’s notice of intent to sole source BioThrax that was issued on December 8, 2016 and is separate from and in addition to the company’s $911 million BioThrax procurement contract with the CDC. BioThrax pricing under this BARDA procurement contract is the same as BioThrax pricing under the CDC follow-on contract.

 

Resverlogix announced that the independent Data and Safety Monitoring Board (DSMB) for the Company’s Phase III BETonMACE trial in high-risk cardiovascular disease (CVD) patients has completed a third planned safety review and recommended that the study should continue as planned without any modifications. The DSMB reviewed available study data and noted that no safety or efficacy concerns were identified. The DSMB will conduct additional periodic reviews and will also perform a futility assessment once 125 adjudicated major adverse cardiac events (MACE) have been observed. Resverlogix, the clinical steering committee, and all investigators remain blinded to the trial data.

 

PharmaCyte Biotech released a statement by Chief Executive Officer Kenneth L. Waggoner that addresses the company’s position on releasing a date for filing its IND application.

 

Inspyr Therapeutics announced that the Company has signed an agreement [or “a preliminary agreement”] with Milost Global, a U.S. private equity firm, for a commitment of up to $100 million. Proceeds will be used to advance Inspyr’s clinical development plans and provide for working capital needs. The agreement includes an investment from Milost of up to $25 million in common stock, priced at a premium to the current share price, and up to $75 million in convertible notes.  Over the coming weeks, Inspyr expects to finalize additional terms, including the amount and number of drawdowns and terms of each tranche, under a definitive agreement.

 

Northwest Biotherapeutics announced that it has entered into definitive agreements with institutional investors for a registered direct offering with gross proceeds of $7.5 million. Rodman & Renshaw, a unit of H.C. Wainwright & Co., acted as the exclusive placement agent for the transaction. The placement is expected to close on or about March 22, 2017, subject to satisfaction of customary closing conditions.

 

 

ANALYST RECOMMENDATIONS

 

Following Omeros’ earnings, Needham analyst Serge Belanger decreased his price target to $22 from $24; Maxim analyst Jason Kolbert increased his price target to $22 from $19.

 

Citi analyst Robyn Karnauskas increased her price target of Calithera Biosciences to $14 from $8, citing the recent collaboration with Incyte to develop CB-1158 and multiple data points over the next 12 months.

 

Wells Fargo analyst Jim Birchenough initiated coverage of the following companies: Lion Biotechnologies with an “outperform” and a valuation range of $16-$19; Adaptimunne with a “market perform” and valuation range $5-$7.

 

HC Wainwright analyst Swayampakula Ramakanth downgraded Proteon Therapeutics to “neutral” from “buy,” and decreased his price target to $3 from $18, citing protocol changes to Patency-2 help provide clarity to regulatory pathway for vonapanitase, but sees continued uncertainty around pricing and commercialization prospects.

 

Following Innocoll Holdings’ earnings, Stifel analyst Annabel Samimy downgraded stock to “hold” from “buy” and decreased her price target to $2 from $9.

 

Raymond James analyst Reni Benjamin increased his price target of Fate Therapeutics to $7 from $4, citing the progress the company is making with the FATE-NK100 and the iPSC programs.

 

JMP analyst Liisa Bayko upgraded Vertex to “market outperform” from “market perform,” citing an updated model and deep dive ahead of key data coming this year.

 

HC Wainwright analyst Corey Davis increased his price target of Aerie Pharmaceuticals to $69 from $66, citing routine forecasting updates to the model.

 

Keybanc analyst Matthew Mishan downgraded Patheon to “sector weight” from “overweight,” citing limited upside over next twelve months.

 

Oppenheimer analyst Hartaj Singh initiated coverage of Regeneron with a “perform” rating, citing the company has a balanced risk/reward profile going forward, with potential for upside.

 

Berenberg analyst Laura Sutcliffe increased her price target of Gilead to $79 from $78, citing HIV drugs will be a major growth driver over the next few years for both Gilead and GlaxoSmithKline.