Autolus, Magenta, MeiraGTx make 3 more biotech IPOs

Three clinical-stage biotechnology companies announced initial public offerings (IPOs) today. Here’s a summary.

Autolus Therapeutics Limited

The clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies says it has begun the roadshow for its initial public offering in the United States of up to 7,812,500 American Depositary Shares (“ADSs”) representing 7,812,500 ordinary shares. The initial public offering price is currently expected to be between $15.00 and $17.00 per ADS, before underwriting discounts and commissions, which would result in an approximate total offering size of between $117.2 million and $132.8 million. The company, which will soon be reorganized as Autolus Therapeutics plc, also expects to grant the underwriters a 30-day option to purchase up to an additional 1,171,875 ADSs at the initial public offering price after underwriting discounts and commissions. Using a broad suite of proprietary and modular T cell programming technologies, the company engineers precisely targeted, controlled and highly active T cell therapies designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. All ADSs to be sold in the proposed offering will be sold by Autolus, which has applied to list its ADSs on the Nasdaq Global Market under the ticker symbol “AUTL.”

Book running managers: Goldman Sachs & Co. LLC and Jefferies LLC.

Lead managers: Wells Fargo Securities, LLC and William Blair & Company, LLC.

Magenta Therapeutics

Based in Cambridge, MA, Magenta is offering 6,666,667 shares of its common stock, subject to market and other conditions, and intends to grant the underwriters a 30-day option to purchase up to an additional 1,000,000 shares of common stock. The company develops therapeutics focused on critical areas of unmet need in the field of bone marrow transplant for patients with autoimmune diseases, blood cancers and genetic diseases. All shares to be sold in the proposed offering will be offered by Magenta. The initial public offering price is currently expected to be between $14.00 and $16.00 per share. Magenta has applied to list the shares on the NASDAQ Global Market under the symbol “MGTA.”

Book running managers: J.P. Morgan, Goldman Sachs & Co. LLC and Cowen.

Lead manager: Wedbush PacGrow.

MeiraGTx Holdings plc

The clinical stage gene therapy company is offering an IPO of 5,000,000 ordinary shares at a public offering price of $15.00 per share, for total gross proceeds of approximately $75.0 million. In addition, the company has granted the underwriters a 30-day option to purchase up to 750,000 additional ordinary shares from the company at the initial public offering price, minus the underwriting discounts and commissions. Headquartered in New York and London, MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. They currently have four ongoing clinical programs, including three ocular indications and a salivary gland condition. Trading is expected to begin today on the Nasdaq Global Select Market under the ticker symbol “MGTX.” The offering is expected to close on June 12, 2018, subject to customary closing conditions.

Book running managers: BofA Merrill Lynch, Barclays and Evercore ISI.

Lead manager: Chardan.

https://bit.ly/2Jx9YER

LeMaitre started at buy by Roth

LeMaitre resumed with a Buy at Roth Capital. Roth Capital analyst Scott Henry resumed coverage of LeMaitre Vascular with a Buy rating and $38 price target, as he expects resumed sales-force expansion to drive organic growth in the near-term and thinks the company’s Reddick divestiture could help fund an acquisition, which could be a catalyst.

https://bit.ly/2JC6fZF

AxoGen rivals ‘not a real threat’: Jefferies

AxoGen competition just noise, not a real threat, says Jefferies. After hosting management at his firm’s conference, Jefferies analyst Raj Denhoy says “all seems to be going the right direction” for AxoGen (AXGN). Not only is surgeon acceptance of the company’s nerve repair products growing but there is more product being used per procedure, Denhoy tells investors in a research note. Further, he believes questions on competition are just noise and not a real threat. The analyst remains skeptical that Integra LifeSciences (IART) “can do much to slow” AxoGen’s momentum. Denhoy keeps a Buy rating on AxoGen with a $45 price target.

https://bit.ly/2xW5y8X

TapImmune raises $70M in a private placement

The private placement will be led by New Enterprise Associates (NEA) with participation from Aisling Capital and Perceptive Advisors, among other new and existing investors. TapImmune will issue 17,500,000 shares of its common stock at a price of $4.00 per share. The aggregate offering size, before deducting the placement agent fees and other offering expenses, is expected to be $70 million. Additionally, TapImmune will issue warrants to purchase 13,125,000 shares of TapImmune common stock at an exercise price of $5.00 per share that will be exercisable for a period of five years from the date of issuance.

https://bit.ly/2LwoTQ7

Novo Nordisk weighs slashing up to 3,000 jobs: Endpoints

As a result of “uncertain and unpredictable markets, Novo Nordisk is considering abandoning its longterm financial target and slashing 3,000 jobs from its global workforce, Endpoints News reports, citing Danish business newspaper Borsen. The giant diabetes drugmaker intends to unveil its cost reduction package along with its Q2 results in August, the report says. Such plans include an adjustment of its growth forecast, which the company put at 5% as recently as May, the report notes. Shares of Novo Nordisk are down 2.1% in New York after the news

https://bit.ly/2sSYh3Y

AbbVie, Roche leukemia med OKd by FDA

AbbVie (ABBV) announced the U.S. Food and Drug Administration has approved, under priority review, VENCLEXTA in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. The approval is based on MURANO Phase 3 clinical trial data which demonstrated a significant improvement in progression-free survival for relapsed/refractory CLL patients, reducing the risk of disease progression or death by 81 percent when compared to bendamustine in combination with rituximab, a standard of care chemoimmunotherapy regimen. is being developed by AbbVie and Roche (RHHBY); it is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

https://bit.ly/2McegDc

Acorda makes case for patent as price soars

Shares of Acorda Therapeutics (NASDAQ:ACOR) rose over 30% today after the company’s lawyers made oral arguments in front of a panel at the U.S. Court of Appeals for the Federal Circuit late Thursday. The appeal was made in response to an earlier decision by a U.S. District Court to invalidate four of the company’s patents for its multiple sclerosis drug Ampyra, which is the top revenue generator for the business and is expected to deliver at least $330 million in sales in 2018. That’s down from $493 million in 2016.

The timing is important. Acorda Therapeutics has one remaining patent on Ampyra, but it expires in July. That means the Federal Circuit decision on the appeal could be the difference between generic versions of the drug hitting the market this summer or sometime much later, perhaps as late as 2027.

As of 11:49 a.m. EDT, the stock had settled to a 22% gain.

The company didn’t issue a press release or SEC filing because a decision on the appeal is still pending, but the higher-than-usual trading volume today indicates bullishness by an institutional investor or two about what was said during the arguments. Investors can listen to audio of the oral arguments in Acorda Therapeutics Inc. v. Roxane Laboratories Inc. that were made in front of the panel yesterday, although it may be difficult to draw conclusions one way or the other.

According to FiercePharma, Acorda CEO Ron Cohen tried to quell angst among the company’s sales representatives by stating that even if Ampyra loses intellectual property protections, the plan is to transfer everyone to accounts selling Parkinson’s disease drug Inbrija. That’s either a bullish comment on the drug’s prospects, since it’s currently awaiting a decision on marketing approval from the Food and Drug Administration, or exactly what investors would expect the CEO to say.

There’s some degree of uncertainty surrounding Acorda Therapeutics right now. The month of June promises to be a volatile one for investors, considering that the Federal Circuit will soon decide whether or not to grant the company’s appeal (and restore the invalidated Ampyra patents) and that the only currently valid patent expires in July. Today’s move may be a bit premature, however, so investors should probably remain on the sidelines until more certainty is provided.

https://bit.ly/2kZOQwc