With several clinical programs ongoing for its humanized monoclonal antibodies, Immunomedics Inc. is raising $24 million through a registered direct offering of 4.8 million shares at $4.95 per share.
The price represents a discount to the Morris Plains, N.J.-based company's closing price of $5.35 on Tuesday. Shares (NASDAQ:IMMU) held steady on Wednesday, trading up 6 cents to close at $5.41.
Immunomedics expects to net about $22.3 million from the deal, which will provide "an extra year of cash," according to Chau Cheng, associate director of investor relations and business analysis. The company reported $31.4 million in cash and marketable securities as of Dec. 31.
Lazard Capital Markets LLC acted as the exclusive placement agent for the offering, which is expected to close around May 7. Proceeds will be used to drive clinical trials with Immunomedics' pipeline of 90-percent-humanized monoclonal antibodies. Cheng called Phase I/II trials the company's "bread and butter," noting that products are ideally out-licensed to partners for Phase III trials.
For example, Immunomedics licensed worldwide autoimmune disease rights for its anti-CD22 antibody, epratuzumab, to UCB SA. Since the mid-2006 deal, UCB discontinued a Phase III program in systemic lupus erythematosus, first citing manufacturing concerns and later to revise the trial protocol. UCB has not disclosed when the trial will resume or if it plans to continue Immunomedics' early clinical work in Sjögren's syndrome. (See BioWorld Today, May 11, 2006.)
The rights to epratuzumab in cancer also are ripe for licensing, and UCB is sitting on the option. Immunomedics already has completed a Phase II trial combining the drug, dubbed IMMU-103, with Rituxan for non-Hodgkin's lymphoma (NHL), but Cheng said the company has no plans to begin Phase III until a partnership deal is signed.
Potential partners can expect additional data next month at the annual meeting of the European Hematology Association, where Immunomedics will present the results of a Phase I/II NHL trial of Y-90-labeled epratuzumab, called IMMU-102. Additionally, two investigator-sponsored Phase II trials are ongoing in B-cell lymphoma and childhood acute lymphoblastic leukemia.
Beyond epratuzumab, Immunomedics is "in negotiations with potential partners for worldwide rights in all indications" to the anti-CD20 antibody IMMU-106. Data will be presented at the American Society of Clinical Oncology annual meeting next month from a Phase I/II, dose de-escalation trial in NHL. Cheng said a 120-mg/m2 dose previously demonstrated activity, so the company is evaluating even lower doses. Immunomedics also plans to begin a Phase I/II trial of IMMU-106 for an undisclosed autoimmune disease this year.
Data from yet another Phase I/II trial with yet another antibody are expected next month at the Society for Nuclear Medicine annual meeting. IMMU-107 is a Y-90-labeled PAM4 antibody initially being studied as a monotherapy for pancreatic cancer, but Cheng said the end goal is to combine the drug with gemcitabine.
Earlier this year, Immunomedics started a Phase I/II trial in multiple myeloma of IMMU-115, a CD74 antibody. Again, the initial study will attempt to prove the safety of the drug as a monotherapy, but the longer-term goal is to advance IMMU-110, which conjugates the CD74 antibody with doxorubicin, into the clinic.
Immunomedics also has completed early trials with IMMU-100, a CEA antibody, and IMMU-101, the Y-90-labeled version. An investigator-sponsored Phase II trial is evaluating IMMU-111, the I-131-labeled version, in resected liver metastases of colorectal cancer.
Cheng said Immunomedics develops and humanizes all of its antibodies internally. He added that the company's majority-owned subsidiary, IBC Pharmaceuticals Inc., recently developed a new platform called 'Dock and Lock,' a "very efficient and quantitative way to generate protein derivatives." The technology will be used internally and licensed externally on a non-exclusive, product-by-product basis.
In 2006, Immunomedics took another step away from its diagnostics roots by discontinuing commercialization of CEA-Scan, its colorectal cancer diagnostic. The company still markets bone infection diagnostic LeukoScan in Europe and Australia, but it no longer puts a material amount of research and development funding into diagnostics.
In other financing news:
• Javelin Pharmaceuticals Inc., of Cambridge, Mass., plans to sell 7.1 million shares in a public offering to support its specialty pharmaceutical pain drugs. Based on Wednesday's closing price (AMEX:JAV) of $6.86, the sale would gross $48.7 million. Javelin will provide an additional 1.07 million shares as needed to cover overallotments. J.P. Morgan Securities Inc. will serve as book-running manager of the offering, with Pacific Growth Equities LLC, Leerink Swann & Co., Allen & Co. LLC, Fortis Securities LLC, and Punk Ziegel & Co. as co-managers.
• Lorus Therapeutics Inc., of Toronto, signed an agreement with investor 6707157 Canada Inc. to recapitalize and reorganize Lorus' business, which would result in $7.8 million in nondilutive financing for the company. Under the agreement, all assets and shares of Lorus will transfer to a new company, which will assume Lorus' name and business. The investor will acquire 41 percent of voting common shares and all nonvoting common shares by paying Lorus approximately $8.5 million. Shareholders outside the U.S. will receive voting common shares, while shareholders in the U.S. will receive a nominal cash payment instead. Shares (AMEX:LRP) rose 3 cents Wednesday to close at 25 cents.
• Neurochem Inc., of Laval, Quebec, privately placed $80 million in aggregate principal amount of convertible notes, which consisted of $40 million of 6 percent senior convertible notes due 2027 and $40 million of 5 percent senior subordinated convertible notes due 2012. In connection with that transaction, the company will issue warrants to purchase, through May 2, 2012, an aggregate of 2.3 million common shares priced at $12.68 each. Net proceeds from the private placement will be used for general corporate purposes, such as advancing its clinical development pipeline, initiating new programs, research for new or existing products and capital expenditures.
• Orexigen Therapeutics Inc., of San Diego, completed its previously announced initial public offering of 7 million shares at $12 per share. The underwriters fully exercised their overallotment option for an additional 1.05 million shares, bringing the total gross to $96.6 million for Orexigen's obesity programs. Merrill Lynch & Co. acted as sole book-running manager for the offering, with J.P. Morgan Securities Inc. as co-lead manager and JMP Securities LLC and Leerink Swann & Co. Inc. as co-managers. Shares (NASDAQ:OREX) rose 38 cents Wednesday to close at $14.25. (See BioWorld Today, April 27, 2007.)
• Pharmacopeia Inc., of Princeton, N.J., priced its previously announced public offering of 7 million shares at $5 per share, a discount to its Tuesday close of $5.43. Shares (NASDAQ:PCOP) fell 31 cents on Wednesday to close at $5.12. An additional 1.05 million shares are available to cover overallotments. CIBC World Markets Corp. is book-running manager in the offering, with Canaccord Adams and Merriman Curhan Ford & Co. acting as co-managers. Pharmacopeia expects proceeds to total $32.3 million, which will be used for clinical trials of dual-acting angiotensin and endothelin receptor antagonist PS433540 and for other programs.