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Cell Therapeutics - Trials and Tribulations of a Biopharm Company


Rick
  • Over time I have occasionally taken advantage of the wild swings that can be exploited in the biopharm realm. One of my prime candidates has always been Cell Therapeutics (NASDAQ:CTIC). That said, I warn you up front it is high risk. Anything in the Biopharm realm is most of the time. You can literally lose the shirt off your back. If you aren't scared read further.....

    Key things to consider: CTIC generally has a consistent range you can play. The tops and trough of these ranges are tradeable in such a way that you can get in/out relatively easy if you are paying attention.

    Another characteristic of Cell Therapeutics. Long term there is an ever so slight chance it could dramatically jump up. Look at May 2011 and April 2009 on the chart to see what I mean. It's primary drugs Pixuvri / Opaxio dramatically affect the SP each time there is a major event, as with all drug trials, positive and negative results can either shoot things into outer space or down into the depths of hell in the blink of an eye.

    The safe bet is to trade a moderate block of shares (moderate so any small changes can push your gain past your brokerage fees if you have them) and then use my tried and proven double up half out technique. If you have more confidence, just chart out the current channel carefully, choose entry and exit points at least 20% within the edges of the range - and don't hesitate to pull the trigger.

    Here is the latest:

All,

Over time I have occasionally taken advantage of the wild swings that can be exploited in the biopharm realm. One of my prime candidates has always been Cell Therapeutics (NASDAQ:CTIC). That said, I warn you up front it is high risk. Anything in the Biopharm realm is most of the time. You can literally lose the shirt off your back. If you aren't scared read further.....

Key things to consider: CTIC generally has a consistent range you can play. The tops and trough of these ranges are tradeable in such a way that you can get in/out relatively easy if you are paying attention.

Another characteristic of Cell Therapeutics. Long term there is an ever so slight chance it could dramatically jump up. Look at May 2011 and April 2009 on the chart to see what I mean. It's primary drugs Pixuvri / Opaxio dramatically affect the SP each time there is a major event, as with all drug trials, positive and negative results can either shoot things into outer space or down into the depths of hell in the blink of an eye.

The safe bet is to trade a moderate block of shares (moderate so any small changes can push your gain past your brokerage fees if you have them) and then use my tried and proven double up half out technique. If you have more confidence, just chart out the current channel carefully, choose entry and exit points at least 20% within the edges of the range - and don't hesitate to pull the trigger.

Here is the latest:

Cell Therapeutics Reports First Quarter 2013 Financial Results - Conference call scheduled today at 4:30 p.m. Eastern time -

SEATTLE, May 2, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today reported financial results for the first quarter ended March 31, 2013.

"In the first quarter, we generated initial commercial sales of PIXUVRI® in countries in the European Union where there is market access pending the completion of the reimbursement process," said James Bianco, M.D., President and CEO of CTI. "Although it is early in the launch, we are pleased with the interest and receptivity of PIXUVRI by key lymphoma opinion leaders who treat patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) and who recognize the significant unmet need that exists for these patients. In addition, our Phase 3 PERSIST-1 clinical trial of pacritinib, an oral, once-daily JAK2/FLT3 inhibitor, in myelofibrosis continues to progress with the opening of additional sites and growing enrollment."

First Quarter and Recent Highlights

European Union (E.U.) Commercial

  • Initiated commercial sales of PIXUVRI® (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL during the first quarter of 2013. CTI is pursuing pricing and reimbursement for PIXUVRI in France, Germany, Italy, Spain and the United Kingdom (UK).

Research and Development

  • Initiated patient enrollment in PERSIST-1, which is the first of two planned investigational Phase 3 studies of pacritinib in patients with myelofibrosis. PERSIST-1 is a randomized trial that is expected to enroll 270 patients in Europe, Australia, Russia and the U.S. and is designed to evaluate the safety and efficacy of pacritinib compared to best available therapy, excluding JAK inhibitors, in patients with myelofibrosis. A second Phase 3 trial is planned to initiate in the second half of 2013.
  • Announced that results from the OPAL Phase 2 study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) were published in Lancet Oncology. Tosedostat is an oral aminopeptidase inhibitor which has been shown to deprive tumor cells of the amino acid building blocks they need to make proteins necessary for tumor cell survival. A Phase 2 investigator-sponsored trial of tosedostat in combination with standard agents in the treatment of patients with AML and myelodysplastic syndrome is ongoing.

Corporate

  • Entered into a senior secured term loan of up to $15.0 million. The first $10 million of the term loan was funded at closing. The proceeds from this loan facility are expected to provide CTI with additional operating capital to advance our Phase 3 clinical development programs.

First Quarter 2013 Financial Results

Total revenues for the first quarter of 2013 were $1.1 million. The revenues were solely attributable to net product sales of PIXUVRI. CTI sells PIXUVRI directly to health care providers and through a limited number of wholesale distributors in the E.U. CTI records product sales upon receipt of the product by the health care provider or distributor. Product sales are recorded net of estimated distributor discounts, government-mandated discounts and rebates, and estimated product returns.

Total operating expenses for the first quarter of 2013 were $19.6 million, compared to $18.1 million for the same period in 2012. Total operating expenses included $2.4 million and $2.0 million of non-cash stock-based compensation expense in the first quarters of 2013 and 2012, respectively. The net loss for the first quarter of 2013 was $19.4 million, or ($0.18) per share, compared to a net loss of $17.4 million, or ($0.43) per share, for the same period in 2012.

As of March 31, 2013, CTI's cash and cash equivalents totaled $44.3 million.

Financial Guidance for 2013

CTI reaffirms prior financial guidance that, for 2013, loss from operations is expected to be approximately $60 to $65 million, excluding non-cash stock-based compensation expense.

Actual financial results for 2013 will vary based upon many factors, including the growth of PIXUVRI sales and determination of reimbursement rates for PIXUVRI in the E.U., the rate of patient enrollment in pacritinib clinical trials that are ongoing and planned for initiation in 2013 and other factors described in our filings with the SEC.

Conference Call Information

CTI management will host a conference call to review its first quarter 2013 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. PDT / 4:30 p.m. EDT/ 10:30 p.m. CET. Participants can access the call at 1-877-941-6010 (domestic) or +1 480- 629-9644 (international). To access the live audio webcast or the subsequent archived recording, visit CTI's website, www.celltherapeutics.com. Webcast and telephone replays of the conference call will be available at approximately two hours after completion of the call. Callers can access the replay by dialing 1-800-406-7325 (domestic) or +1 303-590-3030 (international). The access code for the replay is 4615670#. The telephone replay will be available until Thursday, May 9, 2013.

About Cell Therapeutics, Inc.

Cell Therapeutics (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable. CTI is headquartered in Seattle, WA. For additional information and to sign up for email alerts and get RSS feeds, please visit the company's website at www.CellTherapeutics.com.

I DO own shares of CTIC and I trade it consistently during yearly ranges/channels. To take advantage of any potential spike and not miss the boat, my double up half out technique guarantees you still can gain if you get a major event as with spring 2011.

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