Progenics Pharmaceuticals Inc. is raising about $30 million in a public offering to fund trials of methylnaltrexone, its opioid receptor antagonist, as well as advancing ongoing development programs in HIV and prostate cancer.
The Tarrytown, N.Y.-based company sold 2 million shares of its common stock in a bought deal to CIBC World Markets and UBS Investment Bank, both of New York, at $15.25 per share, said Richard Krawiec, vice president of investor relations and corporate communications. Progenics shares (NASDAQ:PGNX) lost 81 cents Friday to close at $16. Net proceeds are expected to total about $29.3 million.
"This permits us to continue all of our clinical and research and development plans through at least the middle of next year," Krawiec said.
The financing adds to the $31.2 million in cash, cash equivalents and marketable securities the company reported at the end of 2004. Following the offering, Krawiec said, there are about 19.5 million shares outstanding.
Progenics' lead product is methylnaltrexone, or MNTX, a peripheral opioid receptor antagonist designed to treat the side effects of opioid use without interfering with pain relief. Progenics is studying MNTX in three different dosing forms, and the product has yielded promising results so far.
Data reported last month from a Phase III trial in patients with opioid-induced constipation showed that patients with advanced medical illnesses experienced a laxative effect within an hour of being treated with the subcutaneous form of MNTX, and that the drug worked within four hours at more than four times the rate of placebo. (See BioWorld Today, March 11, 2005.)
That form of MNTX, which is typically administered in a hospice setting to patients on opioids for pain during the last months of their lives, makes up the smallest of Progenics' possible markets for MNTX, Krawiec said, but it is a needed treatment area.
It likely will be the first indication for which the company seeks regulatory approval, following the completion of a second Phase III study this year and a new drug application submitted around the end of the year. Krawiec said Progenics is in discussions with potential partners.
An intravenous form of MNTX demonstrated positive results reported in January for a Phase II trial in patients with post-operative bowel dysfunction.
"We're going to meet with the FDA in coming months to design a Phase III program that we hope to initiate this year," Krawiec told BioWorld Today.
An oral form of MNTX for patients taking opioids for chronic pain is expected to finish Phase I testing during the second half of the year and begin Phase II.
Progenics also has been advancing two compounds in the treatment of HIV. PRO 542 and PRO 140 are viral entry inhibitors "in the same class as Fuzeon, but blocking different stages of the viral entry process," Krawiec said. HIV infection is a "three-step process: attachment, binding and fusion. Fuzeon blocks the third step and our two drugs block the first and second steps."
Fuzeon (enfuvirtide) was developed by Trimeris Inc. and F. Hoffmann-La Roche Ltd.
PRO 542, which is designed to block the initial attachment of the virus to the CD4 receptor, is in Phase II studies, while PRO 140, developed to block the co-receptor binding of the virus to the CCR5, is in Phase I.
In prostate cancer, Progenics is working on vaccines to prevent the relapse and occurrence of the disease. Krawiec said one of those vaccines is in Phase I trials.
"But we're particularly excited about monoclonal antibodies to PSMA, the prostate specific membrane antigen," he said, "and expect to have those antibodies linked to a toxin and into the clinic next year" in metastatic prostate cancer.
Though its joint venture with Princeton, N.J.-based Cytogen Corp., Progenics has exclusive worldwide rights to develop in vivo immunotherapies based on PSMA, a cancer antigen expressed on the surface of prostate cancer cells but not found on normal cells.
In other financing news:
• Emisphere Technologies Inc., of Tarrytown, N.Y., raised $15.74 million in a stock offering, selling 4 million shares of common stock and warrants to purchase an additional 1.5 million shares of common stock under the company's shelf registration statement. The shares and warrants were sold in units priced at $3.94 each. Units consisted of one share of common stock and a warrant to purchase 0.375 additional shares at an exercise price of $4 per share. Net proceeds of the offering will be used to repay the company's outstanding indebtedness to an affiliate of Dublin, Ireland-based Elan Corp. plc, and to fund current operations. Emisphere develops oral forms of injectable drugs by applying its eligen technology to those drugs or licensing the eligen technology to corporate partners. Its stock (NASDAQ:EMIS) closed at $3.70, unchanged.
• EntreMed Inc., of Rockville, Md., said Summit, N.J.-based Celgene Corp. exercised warrants to purchase 7 million shares of EntreMed common stock for gross cash consideration of $10.5 million. Through the transaction, the number of EntreMed outstanding shares increased from 42.8 million to 49.8 million. The warrants, exercised at $1.50 per share, were part of a December 2002 transaction in which EntreMed licensed its thalidomide analogue program to Celgene. The $27 million deal called for Celgene to receive all rights to the program, which included ENMD 0995 and ENMD 0997, and assume certain EntreMed license payment obligations. With the addition of the $10.5 million, EntreMed said it has the resources necessary to fund operations into 2007, including the advancement of lead product candidate, Panzem NCD, into Phase II trials for cancer. Shares of EntreMed (NASDAQ:ENMD) rose 15 cents Friday to close at $2.25. (See BioWorld Today, June 3, 2003.)
• GeneOhm Sciences Inc., of San Diego, closed follow-on Series C funding of an undisclosed amount with Partners HealthCare System Inc., along with a syndicate of investors providing funding to accelerate the commercialization of GeneOhm's portfolio of molecular diagnostic products for application in a number of areas, such as rapid detection of bacterial infection and antimicrobial resistance. GeneOhm has two assays cleared by the FDA and Health Canada for rapid detection of Group B Streptococcus and methicillin-resistant Staphylococcus aureus directly from clinical specimens.
• Migenix Inc., of Vancouver, British Columbia, signed a $9.3 million investment agreement with the Canadian government's Technology Partnerships Canada (TPC) program. Under the agreement, TPC will invest the funds in Migenix's research and development activities related to MX-2401, a lipopeptide candidate in preclinical studies for the treatment of Gram-positive bacterial infections. The investment covers development of the product up to and including the completion of the first Phase III trial. Migenix's other products in development include a drug in Phase II trials for hepatitis C, a product in Phase III development for the prevention of catheter-related infections, a Phase I/II product in Alzheimer's disease and a Phase II product for the treatment of acne.Migenix's shares (TSE:MGI) lost 4 cents Friday to close at 68 cents.