The Rodman and Renshaw Annual Global Investment Conference's 14th Annual Healthcare Conference will be held at New York on September 9-11. Here is a look at five presenting companies which could release some interesting news during the conference or shortly after the conference:
1. Cellceutix (CTIX.PK) is an emerging biopharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. The company's flagship compound, Kevetrin, is an anti-cancer drug that has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers that have proven resistant to today's cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism.
Cellceutix Corporation announced on September 10 that it is in discussions with a major university in Europe wishing to conduct clinical trials on Kevetrin, the company's flagship anti-cancer compound. The University, which is ranked in the top ten of universities in Europe by review firm 4 International Colleges and Universities (4icu.org) wishes to test Kevetrin as a combination therapy for leukemia with drugs proprietary to one of the world's largest pharmaceutical companies. Pursuant to a confidentiality agreement, Cellceutix cannot identify the University or the pharmaceutical company at this time.
Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, commented on September 10:
"It seems that the potential of Kevetrin is starting to circle the globe. This University has a distinguished reputation in hematological diseases. Our patent has been published. Only when a compound looks extremely promising do major pharmaceutical companies and universities approach a smaller company like Cellceutix. This gives us a great sense of confirmation as to the potential of Kevetrin and validation in our beliefs about the possible robust number of indications where it could provide a therapeutic benefit."
Therapies for blood cancers such as leukemia are in great demand because of few viable treatments on the market today and a limited number of candidates showing strong promise in clinical research. Acquisitions this year by major pharmas have demonstrated this demand and value of new compounds. On January 26, Celgene Corporation (CELG) acquired Avila Therapeutics in a deal valued up to $925 million. Celgene's focus of the acquisition was AVL-292 as a treatment for patients with B-cell blood cancers. AVL-292 was in Phase I clinical trials at the time of acquisition.
On August 30, a Johnson & Johnson (JNJ) unit, Janssen Biotech, signed a deal to obtain global license rights to blood cancer compound daratumumab from Danish pharmaceutical group Genmab. All told, the deal could total $1.1 billion for Genmab for a drug that is presently in phase I/II clinical trials.
Additionally, Cellceutix reports that its CEO Leo Ehrlich and Chief Scientific Officer Dr. Krishna Menon will be presenting a corporate presentation at the Rodman and Renshaw Annual Global Investment Conference's 14th Annual Healthcare Conference on Tuesday, September 11, 2012, at 3:40 p.m. Eastern Time.
The company reported the first-quarter financial results on May 18 with the following highlights:
|Net loss||$0.3 million|
The company closed a $1 million financing deal on May 14.
Upcoming other milestones
- Cellceutix announced on September 4 that it has concluded negotiations and selected Dr. Reddy's Laboratories (RDY) for the manufacturing of Prurisol, the company's new drug candidate for the treatment of psoriasis. Dr. Reddy's has extensive knowledge of this technology and has expressed excitement to work on this project for Cellceutix. Dr. Reddy's will manufacture Prurisol for oral dosing at levels sufficient for the company's planned phase 2/3 clinical trials. Currently in meetings with clinical sites in Europe and the U.S., the company intends to begin the clinical trials upon completion of the manufacturing.
- Cellceutix announced on August 6 that Kevetrin, the company's flagship anti-cancer drug, has been received at the pharmacies at Dana-Farber Cancer Institute for the commencement of clinical trials.
The stock has a $2.81 price target from the Point and Figure chart. I believe the next major milestone for the stock will be the Phase I trial results of Kevetrin in mid-2013. If the trial results are positive we could see the stock trade as high as $1.5-$2. With negative results the stock would likely fall below $0.5.
2. Cell Therapeutics (CTIC) is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.
Cell Therapeutics announced on September 7 that it will update Pixuvri launch and pacritinib pivotal trial status at the Annual Rodman & Renshaw Global Investment Conference on Tuesday, September 11 at 10:25 a.m. EST.
The company reported the second-quarter financial results on August 1 with the following highlights:
|Net loss||$58.6 million|
This cash amount was before the receipt of $15 million in gross proceeds received from the sale of CTI's Series 15-2 convertible preferred stock and warrants. CTI's operating cash burn rate is expected to average $4 million per month according to the August 1 conference call.
James A. Bianco, Principal Founder, Chief Executive Officer, President and Executive Director commented on the conference call on August 1:
So let me just touch briefly on OPAXIO and brostallicin before we open for questions. We previously mentioned that the GOG has informed us that they have modified the statistical analysis plan to take an earlier look at the survival data of OPAXIO in their trial of monthly maintenance, OPAXIO for 12 months in patients with advanced ovarian cancer who achieved a complete remission after front-line therapy. We believe the first interim analysis will take place in January 2013. In addition with over 900 patients enrolled to date, we anticipate that they should complete the target enrollment of 1,100 patients late next year.
Opaxio (paclitaxel poliglumex, CT-2103; formerly known as Xyotax) is the company's biologically enhanced chemotherapeutic that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. CTI and the Gynecologic Oncology Group [GOG] are presently evaluating OPAXIO as monthly maintenance in a phase III clinical trial in ovarian cancer patients who have achieved a complete response following standard first-line chemotherapy. The trial includes a third paclitaxel arm to determine safety.
In May 2012, Pixuvri received conditional marketing authorization in the E.U. as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin lymphoma [NHL]. Pixuvri is on schedule to launch in Austria and the Nordic countries starting in September, with Germany targeted to launch in November according to the August 1 conference call.
The stock has a $1.5 price target from the Point and Figure chart. The stock has seen steady insider selling since May 2011. There has not been any insider buying since at least May 2011. With positive first interim analysis of Opaxio, that will take place in January 2013, the stock could be trading in a $4-$5 range. If we get negative data, the stock could dip below $2.
3. Acadia (ACAD) is a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders. Acadia has a pipeline of product candidates led by pimavanserin, which is in Phase III development as a potential first-in-class treatment for Parkinson's disease psychosis. Acadia also has clinical-stage programs for chronic pain and glaucoma in collaboration with Allergan (AGN) and two preclinical programs directed at Parkinson's disease and other neurological disorders. All of Acadia's product candidates are small molecules that emanate from discoveries made using its proprietary drug discovery platform.
Acadia announced on September 5 the completion of enrollment in its ongoing pivotal Phase III trial with pimavanserin in patients with Parkinson's disease psychosis [PDP]. Top-line results from this trial are expected to be announced by the end of November 2012.
Currently, there is no FDA-approved therapy for Parkinson's Disease Psychosis [PDP]. The company believes that pimavanserin has the potential to be the first safe and effective drug that will treat PDP without compromising motor control, thereby significantly improving the quality of life for patients with Parkinson's disease. PDP is a large unmet medical need and represents what the company believes is an ideal lead indication for pimavanserin.
Acadia will present at Rodman & Renshaw Annual Global Investment Conference on Tuesday, September 11, 2012, at 3:15 p.m. EST.
The company reported the second-quarter financial results on August 8 with the following highlights:
|Net loss||$5.4 million|
Acadia expects that its current cash resources and anticipated payments from its existing collaborations will be sufficient to fund its operations at least into the second quarter of 2013.
The stock has a $8.38 price target from the Point and Figure chart. The latest insider buy transaction in the stock was in May 2009 and the latest insider sell transaction was in February 2008. I am expecting the stock to reach a $3-$4 price range after positive Phase III results from the pimavanserin trial in November. If we do get negative results the stock could drop below $1.
4. AcelRx Pharmaceuticals (ACRX) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx's lead product candidate, the ARX-01 Sufentanil NanoTab PCA System, which is currently in Phase III clinical development, is designed to solve the problems associated with post-operative intravenous patient-controlled analgesia which has been shown to cause harm to patients following surgery because of the side effects of morphine, the invasive IV route of delivery and the inherent potential for programming and delivery errors associated with the complexity of infusion pumps. AcelRx has two additional product candidates which have completed Phase II clinical development: ARX-02 for the treatment of cancer breakthrough pain, and ARX-03 for mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician's office. A fourth product candidate, ARX-04, is a sufentanil product for the treatment of moderate-to-severe acute pain, and AcelRx plans to initiate a Phase II study funded by a grant from USAMRMC, contingent on approval of the proposed clinical protocol for the study by USAMRMC.
AcelRx announced on August 29 that the U.S. Patent and Trademark Office [USPTO] has recently issued AcelRx Patent Number 8,252,328 entitled "Bioadhesive Drug Formulations for Oral Transmucosal Delivery," and Patent Number 8,252,329 also entitled "Bioadhesive Drug Formulations for Oral Transmucosal Delivery." The '328 and '329 patents each make claims to a bioadhesive tablet for oral transmucosal administration of sufentanil. These newly issued patents will provide intellectual property protection for sufentanil NanoTab based products until at least January 5, 2027. AcelRx currently has more than 70 pending patent applications worldwide and continues to file additional new patent applications to further strengthen its market exclusivity.
AcelRx announced on August 23 dosing of the first patient in the third of three planned Phase 3 studies for ARX-01, the Sufentanil NanoTab PCA System, its novel sublingual patient-controlled analgesia [PCA] system. This third ARX-01 Phase 3 study is a randomized, double-blind, placebo controlled efficacy and safety trial in adults following hip or knee replacement surgery.
Richard King, AcelRx's president and CEO commented on August 23:
The start of our third Phase 3 clinical trial for ARX-01 is an important milestone for our lead Sufentanil NanoTab development program. The results of all three Phase 3 registration studies are expected to form the basis of a New Drug Application for ARX-01, which we plan to submit to the FDA during the third quarter of 2013. The ARX-01 System is designed to provide an attractive post-operative pain treatment alternative compared to the current standard of care that utilizes intravenous pumps primarily delivering morphine.
AcelRx will present at Rodman & Renshaw Annual Global Investment Conference on Tuesday, September 11, 2012 at 9:35 a.m. EDT.
The company reported the second-quarter financial results on August 9 with the following highlights:
|Net loss||$7.2 million|
AcelRx anticipates that research and development expenses for the remaining two quarters of 2012 and into 2013 will increase as AcelRx seeks to execute and complete three Phase III clinical trials with ARX-01. Development of ARX-04 through Phase II clinical work and Phase III preparatory work is expected to be funded by a grant from USAMRMC, contingent on approval of the proposed clinical protocol for the study by USAMRMC. The development of ARX-04 beyond Phase II and initial preparations for Phase III is dependent on the identification of sources of additional funding. Additionally, AcelRx anticipates modest increases in general and administrative expenses due to costs associated with operating as a public company and expansion of its corporate infrastructure to support ongoing development of its product candidates.
AcelRx believes its current cash, cash equivalents and investments are sufficient to fund operations into the second quarter of 2013.
I wrote an article about AcelRx on July 30. The stock has seen only insider buying (no selling) since February 2011. I believe the stock could reach a $4-$5 range after positive Phase III results from the three different ARX-01 trials due in 4Q2012/1Q2013. If we get negative results the stock could trade below $2.
5. Æterna Zentaris (AEZS) is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products.
Aeterna Zentaris announced on August 28 that a first patient has been recruited for a Phase 2A trial with its ghrelin agonist, AEZS-130 in patients with cancer cachexia. The study is conducted under a Cooperative Research and Development Agreement [CRADA] between Aeterna Zentaris and the Michael E. DeBakey Veterans Affairs Medical Center which is funding the study. Cachexia, characterized by diminished appetite and food intake in cancer patients, is defined as an involuntary weight loss of at least 5% of the pre illness body weight over the previous 6 months.
Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated:
This is a key study as it allows us to venture into the field of cancer-cachexia, an indication with high unmet medical needs. Because cachexia is very common among cancer patients, our oral ghrelin agonist, AEZS-130, could represent a novel treatment option for many of the 1.5 million people diagnosed with cancer each year, in the U.S. alone.
The company will be presenting a corporate overview at the Rodman & Renshaw 14th Annual Global Investment Conference on Tuesday, September 11, 2012, at 1:35 pm EST.
The company reported the second-quarter financial results on August 14 with the following highlights:
|Net income||$4.5 million|
The average cash burn rate has been $2.17 million per month.
Aeterna has the following upcoming milestones according to a September company presentation:
- Phase 3 in multiple myeloma: Predefined interim analysis in Q1-2013
- SPA filing Phase 3 in endometrial cancer
- Initiate patient recruitment in triple-negative breast cancer Phase 2 study
- Results on ongoing Phase 2 study in castration- and taxane-resistant prostate cancer
- Results of Phase 2A study in cancer-induced cachexia
AEZS-130 diagnostic test in AGHD
- Outcome of Fast-track and rolling submission requests to FDA
- File NDA as diagnostic test for AGHD in the U.S.
- File CTA for Phase 1 trial in prostate cancer
I believe the stock could have a run-up leading into the Perifosine interim Phase III data due in Q1-2013. If the data is positive we could reach a $0.80 - $1 range. With negative data the stock could fall below $0.3.