Alder Biopharmaceuticals Inc. plans to add up to $197.2 million to its bank in an upsized follow-on offering to support development of its midstage migraine prevention candidate, ALD403, and a preclinical Cushing's syndrome therapy, ALD1613. The Bothell, Wash.-based company raised the offer to 6 million shares of common stock priced at $29.50 each from an initial planned offering of 4 million shares at $27.13.
Alder's ALD403, a calcitonin gene-related peptide (CGRP) blocker, has already completed a three-month double-blind, randomized, placebo-controlled proof-of-concept study in 163 patients suffering high frequency migraines. The company has also begun a phase IIb dose-ranging trial for preventive treatment of chronic migraines with an intravenous formulation. Next, it plans to initiate a second phase IIb study in high frequency migraines with a subcutaneous formulation in the first half of this year, with the goal of initiating pivotal phase III trials in 2016. (See BioWorld Today, Aug. 7, 2014.)
The company has gained significant attention as one of the frontrunners in the small but active CGRP space, which has been validated in part by the attentions of heavyweights like Teva Pharmaceutical Industries Ltd. and Amgen Inc. Brian Abrahams, a senior analyst at Wells Fargo Securities LLC, wrote at the beginning of December that he was "very positive on the prospects for ALDR's ALD403 to play a significant role in the emerging migraine prophylaxis space and continue to expect ALDR share appreciation as enthusiasm for CGRP antagonists increases with evolving data."
The follow-on offering is Alder's first since the company raised $80.1 million in its May 2014 initial public offering. Shares of Alder (NASDAQ:ALDR) fell $1.09 Thursday to close at $29.39.
Alder granted the underwriters a 30-day option to purchase up to 900,000 additional shares of common stock at the public offering price. The offering is expected to close Jan. 13. Credit Suisse, Leerink Partners and Wells Fargo Securities are acting as joint book-running managers. Sanford C. Bernstein is acting as co-manager.
'AVALANCH' OF FUNDRAISING
Joining in the New Year's party, a follow-on offering by Avalanche Biotechnologies Inc. could gross $141.6 million, while Cempra Inc. stands to net $120.6 million in an offering of its own.
Avalanche, which is advancing the gene therapy AVA-101 for wet age-related macular degeneration (AMD), said it expects to raise $141.6 million in its follow-on. The Menlo Park, Calif.-based company priced an offering of about 2.4 million shares of its common stock at $59 per share. About 2 million of the shares are being offered by Avalanche, while the rest are being offered by existing stockholders. Jefferies LLC, Cowen and Co. LLC and Piper Jaffray & Co. are acting as joint book-running managers and William Blair & Co. LLC is acting as co-manager. The underwriters have been granted a 30-day option to purchase up to an additional 359,918 shares of common stock from Avalanche.
The bet with AVA-101, currently in phase IIa testing, is that as as a single-administration therapy continuously producing therapeutic levels of a naturally occurring anti-VEGF protein, it would be able to grab a significant share of the billions spent annually on other wet AMD therapies such as Lucentis (ranibizumab, Roche AG), which requires injections every four to eight weeks to maintain efficacy. The company expects to receive top-line data from the ongoing phase IIa study in mid-2015. It owns exclusive rights to develop and commercialize AVA-101 worldwide. (See BioWorld Today, Nov. 7, 2014.)
Avalanche closed its initial public offering in August 2014, raising about $106.8 million in net proceeds. This was its first follow-on offering. Shares (NASDAQ:AAVL) fell 91 cents Thursday to close at $59.17.
Cross-country, Chapel Hill, N.C.-based Cempra, an infectious disease specialist with antibiotic solithromycin for community acquired bacterial pneumonia (CABP) in phase III, filed to sell about 5.3 million shares at $24.50 each, an offering that could net the company $120.6 million. The company also has granted the underwriters a 30-day option to purchase up to an additional 787,500 shares, which would result in additional net proceeds of about $18.1 million, if exercised in full. Morgan Stanley & Co. LLC and Cowen and Co. LLC are acting as joint book-running managers. Stifel, Nicolaus & Co. Inc. is acting as lead manager, and Oppenheimer & Co. Inc. and Ladenburg Thalmann & Co. Inc. are acting as co-managers.
Cempra plans to use proceeds of the financing to fund R&D activities, including continued clinical and regulatory development of solithromycin in CABP and gonorrhea and for work on another antibiotic, Taksta (fusidic acid), in refractory bone and joint infections. The funds will also support the company's preparation for commercialization of solithromycin in CABP, working capital, as well as general corporate and administrative expenses. (See BioWorld Today, Dec. 18, 2013.)
Roth Capital Partners LLC expects that solithromycin could reach peak sales of about $2 billion, becoming the new standard of care for both CABP and gonorrhea. Given those prospects and strong interest in the antibiotics space, evidenced by Merck & Co. Inc.'s impending acquisition of Cubist Pharmaceuticals Inc., Roth suggested Cempra could be an attractive M&A target. (See BioWorld Today, Dec. 9, 2014.)
The new offering is Cempra's first since its June 2013 public offering raised $54.2 million. Shares of Cempra (NASDAQ:CEMP) fell 86 cents Thursday to close at $24.88.
Life sciences companies raised a total of $16.7 billion in follow-on offerings during 2014, $1.3 billion of which arrived in January, according to BioWorld Snapshots.
In other financings news:
Brainstorm Cell Therapeutics Inc., of Petach Tikvah, Israel, said it will raise gross proceeds of about $13 million through a new warrant exercise agreement with certain holders of warrants issued in its June 13, 2014, private placement. The holders agreed to exercise their warrants in full, exchanging them for about 2.5 million shares of common stock, at an exercise price of $5.22 per share, a 4 percent premium to the closing price of $5.03. For each warrant exercised, Brainstorm agreed to issue 1.5 new warrants to the holders to purchase unregistered shares of common stock at an exercise price of $6.50. Brainstorm will file a registration statement covering the resale of the additional shares of common stock underlying the newly issued warrants. Proceeds of the transaction will support the company's Nurown program in amyotrophic lateral sclerosis and its plans for expanded development in other indications through 2016. The company said the deal will strengthen its financial position by adding about $16 million to its balance sheet from warrant exercises since Jan. 1, 2015, in addition to a previously announced nondilutive $1.1 million grant from the Israeli Office of the Chief Scientist. Shares of Brainstorm (NASDAQ:BCLI) fell 46 cents Thursday to close at $4.57.
Cellectis SA, of Paris, said it plans to conduct a registered initial public offering in the U.S., though the timing, number of shares and price of the proposed offering have not yet been determined. Cellectis, a gene-editing company focused on developing immunotherapies based on gene-edited engineered CAR T-cells, currently is listed on the NYSE Alternext market under ALCLS.
Delmar Pharmaceuticals Inc., of Vancouver, British Columbia, said it has begun an offer to exchange new shares of the company's common stock for outstanding company warrants to purchase up about 6 million shares of common stock at a ratio of one share for every three warrants tendered. The company said it is attempting to reduce its derivative warrant liability as part of its strategy to build sufficient stockholders equity in partial fulfillment of the requirements to up-list its common stock to a national securities exchange such as Nasdaq or NYSE from the Over-the-Counter market where it trades now. Shares of Delmar (OTC:DMPI) fell 2 cents Thursday to close at 86 cents.
The Medicines Co., of Parsippany, N.J., priced a $350 million private offering of convertible senior notes due 2022, an increase from the $300 million offering it had previously announced. The notes will bear interest at a rate of 2.5 percent per year, payable semiannually. The company has granted to the initial purchasers a 30-day option to purchase up to an additional $50 million in aggregate principal amount of the notes. Net proceeds from the offering are expected to total about $338.6 million. Medicines' shares (NASDAQ:MDCO) rose 5 cents Thursday to close at $24.84.
Novocure Inc., of St. Helier, Jersey Isle, entered a term loan agreement with an investment fund managed by Pharmakon Advisors LP that will provide it with up to $100 million of available borrowing capacity. Under the terms of the agreement, Pharmakon will provide $25 million at closing. Up to $75 million of additional funding will be available to the company, at its option, through June 30, 2016. The agreement has a term of five years from the initial funding date. Novocure, which has an approved therapy for glioblastoma, said the agreement will provide it with added flexibility to ensure Novocure is in a strong position to advance commercial and clinical development activities in upcoming years.
Retrosense Therapeutics Inc., of Ann Arbor, Mich., said it secured $6 million in a series A financing to further investigate the use of gene therapy and optogenetics to restore vision loss. The investment syndicate includes Nerveda, Blue Water Angels, SDL Ventures, Tech Coast Angels and Michigan Economic Development Corp. Proceeds should enable completion of preclinical studies needed to support an investigational new drug application for its lead compound, RST-001, for the treatment of retinitis pigmentosa, a cause of vision loss and blindness.
Stemline Therapeutics Inc., of New York, priced an underwritten public offering of 3.8 million shares at $15.75 per share in a bid to raise gross proceeds of $59.85 million. The company has granted the underwriters a 30-day option to purchase up to an additional 570,000 shares of common stock. Stemline intends to use the net proceeds to fund the clinical development of SL-401, SL-701, the development of its preclinical pipeline and other general corporate purposes. Jefferies LLC and Cowen and Co. LLC are acting as joint book-running managers. Aegis Capital Corp is acting as co-lead manager. Roth Capital Partners, Ladenburg Thalmann and H.C. Wainwright & Co. are acting as co-managers. The offering is expected to close on Jan. 13. At the same time, the company said it has has exclusively licensed from Canbas Co. Ltd., of Shizuoaka, Japan, rights to develop and commercialize an oral small-molecule reversible inhibitor of exportin-1, a nuclear transport target also known as chromosome region maintenance-1. Stemline, which will call the molecule SL-801, acquired worldwide rights with the exception of Japan, Korea, Taiwan and China. Stemline shares (NASDAQ:STML) fell $1.73 Thursday to close at $15.77. Canbas shares (4575:JP) rose ¥254 (US$2.12) Thursday to ¥1,830.
Surface Oncology Inc., a new Cambridge, Mass.-based company developing cancer immunotherapies, closed a $35 million series A investment round led by Atlas Venture, which initially seeded the company in 2014, Fidelity Biosciences, Lilly Ventures and New Enterprise Associates. Amgen Ventures, Novartis Institute for Biomedical Research and Elliott Sigal, former head of R&D at Bristol-Myers Squibb Co., also joined the financing. The company said it has active preclinical programs in areas including therapies designed to improve the effectiveness of antigen presentation; to block the activity of suppressor cells in the tumor microenvironment; or to counter the impact of specific inhibitory cytokines and metabolites.
Trevi Therapeutics Inc., of New Haven, Conn., said it closed a $15 million senior secured term loan agreement provided by Solar Capital Ltd. as collateral agent and lender and Square 1 Bank as lender. Funding will support ongoing clinical trials testing Nalbuphine ER in chronic pruritis and prurigo nodularis.
Vaxart Inc., a privately held South San Francisco-based firm developing vaccines that are administered by tablet rather than by injection, raised $18.4 million through a convertible note financing. Care Capital of Princeton, N.J., Vaxart's lead investor and largest shareholder, led the round. Vaxart last raised funds in July 2013. The company said the additional capital will allow it to advance its seasonal influenza tablet vaccine and significantly expand its clinical pipeline beyond influenza. It expects to conduct phase I studies for two new indications in 2015, Ebola and norovirus. Vaxart's respiratory syncytial virus tablet vaccine candidate and the company's first therapeutic tablet vaccine candidate, for the treatment of herpes simplex 2, are currently in preclinical testing.