Less than a week away, the Rodman & Renshaw 13th Annual Healthcare Conference from September 11-13th will showcase a host of small biotech companies presenting their products, trial data and financials to industry executives, private equity firms, institutional investors, private investors, venture capitalists and business development executives. The information presented will be invaluable to traders and investors as they value shop for entries into the oversold biotech sector and look for key updates that companies often see this venue fit for to announce to the investment world. Of the many key biotech companies presenting (over two hundred on the website as of September 3rd) there are many that are expected to give key updates that are pertinent to investors. Following is a small selection of some key biotechs that investors should be focusing on.
Curis, Inc. (NASDAQ: CRIS)
Curis’ president and CEO, Dan Passeri, will be providing an overview of Curis' proprietary drug candidates including CUDC-101, a first-in-class EGFR/Her2/HDAC inhibitor, and CUDC-907, a dual PI3 kinase and HDAC inhibitor. Curis’ most advanced product is a collaborative effort with Genentech. Originally termed GDC-0449 and thereafter vismodegib, Genentech is currently preparing an NDA for the advanced basal cell carcinoma indication. Although Genentech will likely first announce the NDA, an update on the progress of the NDA could also be possible. Terms of the partnership entitle Curis to receive milestone payments upon submission of the NDA to the FDA as well as the equivalent European agency as well as additional payments for regulatory approvals and royalties on sales. More information on the drug and its indication may be found in an earlier article focusing on it and its indication.
BioSante Pharmaceuticals (NASDAQ: BPAX)
BioSante president and CEO, Stephen Simes, will be providing a company overview as well as an update on LibiGel Phase III clinical development program and planned NDA submission. LibiGel is BioSante’s lead product and the company will be submitting an NDA for female sexual dysfunction (FSD), which was developed by the company under an FDA SPA. If the trial follows the SPA criteria properly and meets the pre-determined trial targets the chance for regulatory approval is greatly increased. BioSante is currently conducting three Phase III LibiGel clinical studies, and a new drug application (NDA) is planned to be in 2012.
Cardium Therapeutics (AMEX: CXM)
Cardium chairman and CEO, Christopher Reinhard, will be providing a company overview. Although the PR announcing the presentation doesn’t give specifics on what Mr. Reinhard will be speaking on, the second quarter financial results and company update give hints as to what investors might expect. Phase III data on their Generx Angiogenic study are likely with an update on enrollment. Generx is an innovative DNA-based angiogenic therapy being developed for the treatment of myocardial ischemia due to advanced coronary artery disease. The Generx program includes four randomized placebo-controlled studies that enrolled more than 650 patients at over 100 medical centers in the U.S. and Western Europe. Cardium could also provide an update on the status of its pending FDA 510(k) application seeking clearance from the FDA to market the Company's Excellagen formulated bovine Type I collagen topical gel for the treatment of dermal wounds. The Company also continues to be in discussions with potential commercialization partners for the marketing of Excellagen in the U.S. and internationally and is working with potential new partners for additional product opportunities for its Excellagen formulation. Additionally, Mr. Reinhard could be providing an update on the proposed acquisition of all the assets of Transdel Pharmaceuticals. Since their earlier announcement on the proposed acquisition of Transdel, a major creditor with the company, which had favored the acquisition, now opposes the transaction. This forces Cardium to re-evaluate the transaction versus other “business opportunities currently under consideration”.
NeurogesX, Inc. (NASDAQ: NGSX)
NeurogesX president and CEO, Anthony DiTonno, and CFO/COO, Stephen Ghiglieri, will be giving a corporate update. The Company's lead product, Qutenza, is a localized dermal delivery system containing prescription strength capsaicin that is currently approved in the United States and the European Union. Qutenza is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). An update on the company’s sNDA submission to expand the label to include pain management associated with HIV-associated peripheral neuropathy (HIV-PN) also known as HIV-associated neuropathy (HIV-AN) and HIV-distal sensory polyneuropathy (HIV-DSP) is also likely. The most important and most likely catalyst for investors to be presented by NeurogesX could be on the Company's most advanced product candidate, NGX-1998. It is a topically-applied liquid formulation to treat pain associated with neuropathic pain conditions such as PHN. NGX-1998 has completed three Phase 1 clinical trials and patient enrollment has been completed in a Phase 2 clinical trial of NGX-1998 in PHN patients. Although the June 16 press release announcing the enrollment completion stated that the top-line data will be available by the end of the year, some interim data analysis or even the top-line data could even be a possibility.
Cytosorbents Corporation (OTC: CTSO)
Cytosorbents has yet to release a notification of presenting at the conference. However, the company is listed on the website as a presenting company. The likely key catalyst for this security could come in the form of an update on the government funding from DARPA (Defense Advanced Research Projects Agency), an agency of the United States Department of Defense responsible for the development of new technology for use by the military. On February 8, 2011 the agency posted a solicitation for “innovative research proposals to manage the life-threatening blood infection known as sepsis.” If one reads Cytosorbents’ description of its Mark CE approved Cytosorb device and then the solicitation, "The goal of the Dialysis Like Therapeutics (DLT) program is to develop a portable device capable of controlling relevant components in the entire blood volume on clinically relevant time scales," the dots can be connected very easily to show how well Cytosorb fits DARPA’s solicitation description. The solicitation stated, “The IRB approval process can last between one to three months, followed by a DOD review that could last between three to six months. No DOD/DARPA funding can be used towards human subjects research until ALL approvals are granted." The June 2011 letter to shareholders from Cytosorbents stated, “At the end of March, we submitted our technology, along with an ambitious development program, as a key component of a broader multi-institutional proposal. We expect to hear definitively about our application soon." This puts a likely timeframe from the end of August to December 2011.
SuperGen, Inc. (NASDAQ: SUPG)
SuperGen CEO, James Manuso, and president, Harren Jhoti, will be presenting corporate updates and an overview. Changes are coming to SuperGen including a name and ticker symbol change, which will become effective while at the conference. On September 12 the company will begin operating under the name Astex Pharmaceuticals with a NASDAQ ticker symbol ASTX. This occurs after Astex Therapeutics Limited became a wholly owned subsidiary of SuperGen, Inc. on July 20, 2011. In addition to these changes the company could give an update on its Dacogen regulatory process. The drug is already approved for or treatment of patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes, and Intermediate-1, Intermediate-2 and High-Risk International Prognostic Scoring System (IPSS) groups. However, an sNDA accepted by the FDA on July 13thcould allow a change of labeling to include it for injection in the treatment of acute myeloid leukemia. The sNDA was filed by partner Eisai, Incorporated which would pay royalties to SuperGen/Astex upon approval and marketing. The PDUFA date for the Dacogen acute myeloid leukemia indication is March 6, 2012. An update on the phase I trial for SGI-110, a second-generation hypomethylating agent, in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia is also possible as the company announced enrollment of its first patient on January 5th, 2011.
Repros Therapeutics (NASDAQ: RPRX)
Repros Therapeutics will provide an update on its Androxal and Proellex programs. According to the press release, the presentation will focus on the Androxal program, which the company sees as the most important near-term value driver. Repros recently released phase II data on its Androxal trial for hypogonadal men (low production of testosterone). The trial also includes a small subset of hypogonadal men with type II diabetes to investigate various factors indicative of glycemic control following the treatment with blinded placebo, 12.5 or 25 mg Androxal. Included in the assessment are changes from baseline to end of active dosing in HbA1c (glycosylated hemoglobin) and fasting plasma glucose. HbA1c level is used to determine the average plasma glucose concentration in an individual over an extended period of time and is useful in measuring the response of patients to various treatments for diabetes. Key data in the trial indicated that the men in the Androxal arms that achieved morning levels of T > 450 ng/dl also exhibited statistically significant reductions in HbA1c compared to men in the Androxal arms that did not achieve that level of testicular stimulation. A key phrase in that press release which directly pertains to the updates intended at the conference stated, “Repros intends to seek a corporate partner to further develop this product and indication. The Company has a broad pending patent application for the use of anti-estrogens in the treatment of type 2 diabetic men.” The company’s Proellex trial for uterine fibroids and endometriosis had an FDA hold on it due to liver toxicities noted at the 50mg dosage. On June 10, 2010 the hold was partially lifted to permit a single dose escalation trial under a partial clinical hold status. The new study will test 5 different doses of Proellex (1, 3, 6, 9 and 12 mg) with 1 mg being the first dose tested. Each dose will be compared to placebo with weekly evaluations of liver function during both the placebo and drug period. The next higher dose would not be allowed to commence until the Chairman of the outside drug safety monitoring board, a hepatologist, reviews the liver safety data from a minimum of 8 subjects from the cohort that were dosed for a minimum of 8 weeks. As of a June 23rd, 2011 press release the company had completed dosing through 6mg, which is key as the original 50mg demonstrated excellent efficacy. If a proper safety/efficacy tradeoff can be obtained, approval after perhaps an abbreviated trial could be very possible.