Threshold Pharmaceuticals, Inc (THLD): Opiniones

Gracias!!!

Animado estoy!!, ahora a ver si sube Thld, y no tengo que volver a trabajar!! jajaja

Saludos!!

Animo y suerte compañero

Mucha suerte. Espero que dure poco tu situación y que se convierta en un revulsivo profesional. Un abrazo

alguien sabe el premarket como va?

El problema es que no va !
http://www.nasdaq.com/symbol/thld/premarket

pone k abre a 6,65

yo como vea que abre y se va para abajo mas de un 4% vendo todo y a esperar.

las tengo a 5 dolares de media

Pues ha llegado a 6.41 en apertura, pero ha recurperado rápidamente.
Poco volumen, así que no es muy significativo.
Tal vez posiciones poco defendidas y por eso llego ahi !

10-Q: THRESHOLD PHARMACEUTICALS INC
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(EDGAR Online via COMTEX) -- ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the "Risk Factors" section of this Quarterly Report on Form 10-Q. Other than statements of historical fact, statements made in this Quarterly Report on Form 10-Q are forward-looking statements within the meaning of Section 21E of the Exchange Act, and

the progress of our clinical programs, including estimated milestones;

estimates of future performance, capital requirements and needs for financing;

uncertainties associated with obtaining and enforcing patents and other intellectual property rights; and

the costs and timing of obtaining drug supply for our pre-clinical and clinical activities.

Forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual events or results may differ materially from those discussed in the forward-looking statements as a result of various factors. For a more detailed discussion of the potential risks and uncertainties that may impact their accuracy, see the "Overview" section of this Management's Discussion and Analysis of Financial Condition and Results of Operations and the "Risk Factors" section in Part II of this quarterly report on Form 10-Q. Forward-looking statements reflect our view only as of the date of this report. We undertake no obligation to update any forward-looking statements. You should also review carefully the cautionary statements and risk factors listed in our Annual Report on Form 10-K for the year ended December 31, 2011, and in our other filings with the SEC, including our Forms 10-Q and 8-K and our Annual Report to Shareholders.

Overview

We are a biotechnology company focused on the discovery and development of drugs targeting the microenvironment of solid tumors and the bone marrows of patients with some hematologic malignancies (blood cancers) as novel treatments for patients living with cancer. The microenvironment of these tissues is characterized by, among other things, hypoxia or lack of oxygen. This hypoxic environment is known to be resistant to standard chemotherapy and radiation. It is thought to be responsible for the poor prognosis of patients with solid tumors and hematological malignancies and treating the hypoxic environment is currently believed to be a significant unmet medical need. Our hypoxia activated prodrug ("HAP") product candidates, including TH-302, are designed to specifically target the hypoxic microenvironment of tumors by selective activation of the prodrug to release a potent cytotoxin. Our focus is on product candidates for the treatment of patients with cancer. Our clinical development efforts are currently focused on TH-302, for which we entered a license and co-development agreement with Merck KGaA for worldwide development and commercialization. TH-302, which we discovered, is a novel drug candidate that is activated under severe hypoxic conditions and was designed to specifically target the severe hypoxic regions that are believed to be present in all solid tumors and the bone marrows of patients with some hematologic malignancies.

TH-302 is currently in Phase 1, Phase 2 and Phase 3 clinical trials. The development plan for TH-302 is designed to investigate the efficacy and safety across a broad range of solid tumors and hematologic malignancies. We reported updated top-line results from the initial Phase 1 monotherapy trial of TH-302 (401 trial) including indication specific data in patients with metastatic melanoma and small-cell lung cancer (SCLC). We have also reported results from each of four Phase 1/2 combination therapy investigations of a chemotherapy agent plus TH-302 in solid tumors involving combining TH-302 with doxorubicin, gemcitabine, docetaxel and pemetrexed. We have also reported results from our clinical study of TH-302 in patients with advanced leukemias (407 trial) and initiated a clinical study of TH-302 in patients with multiple myeloma (408 trial). In addition, investigations have been initiated to explore the combination of TH-302 with anti-angiogenic therapies including a Phase 1/2 dose escalation clinical trial of TH-302 in combination with sunitinib (Sutent (R) ) in patients with advanced renal cell carcinoma or gastrointestinal stromal tumors (410 trial) and physician initiated clinical trial of TH-302 administered either in combination with bevacizumab (Avastin (R) ) in patients with recurrent high grade astrocytoma including glioblastoma or in combination with pazopanib (Votrient (R) ) in patients with solid tumors.

In February of 2012 we reported top-line results from the randomized and controlled Phase 2 trial of TH-302 plus gemcitabine in patients with pancreatic cancer (404 trial). The median progression-free survival (PFS) was 5.6 months for patients treated with gemcitabine in combination with TH-302 at 240 mg/m2 and 340 mg/m2 compared to 3.6 months for patients treated with gemcitabine alone. The PFS hazard ratio comparing the TH-302 combination to gemcitabine alone was 0.61 (95% confidence interval:0.43-0.87) which was highly statistically significant (p = 0.005) and represented a 63% improvement in PFS. The response rate in the combination arms was 22% compared to 12% in the gemcitabine alone group. Results also demonstrated greater efficacy in the higher TH-302 dose group compared to the lower dose group. The combination was well tolerated with a safety profile that was consistent with our prior study of this combination regimen. As in that study, skin and mucosal toxicities related to TH-302 were dose dependent but not dose limiting. In April 2012, we provided detailed results from our 404 trial at the American Association of Cancer Research (AACR) annual meeting including results for each of the 240 mg/m2 and 340 mg/m2 TH-302 combination arms. The median PFS was 6.0 months in the 340 mg/m2 group. The response rate was 27% in the 340 mg/m2 group. A similar dose dependency was reported in serum CA19-9 levels. There was greater drug exposure in the combination groups with a median of 4 cycles received with gemcitabine alone compared with 5 cycles in the 240 mg/m2 group and 6 cycles in the 340 mg/m2 group. The combination safety profile was consistent with the prior study of this combination regimen. As in that study, skin and mucosal toxicities and were less than what has been seen at the single-agent maximum tolerated dose of TH-302, which was previously established at 575 mg/m2. The incidence of grade 3/4 thrombocytopenia and grade 3/4 neutropenia was significantly higher in the combination arms and highest in the 340 mg/m2 group. Discontinuations for adverse events were lowest in the 340 mg/m2 group. We expect to provide detailed updated top-line results, including mature data on overall survival in the second half of 2012.

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During 2011, we presented updated top-line results from our Phase 1/2 combination therapy in patients with soft tissue sarcoma treated with doxorubicin plus TH-302 at the maximum tolerated dose of 300 mg/m 2 (403 trial). In February 2011, we reached agreement with the FDA on the design and planned analysis of a pivotal Phase 3 trial in patients with soft tissue sarcoma (406 trial). As part of the Special Protocol Assessment (SPA) submission, the FDA agreed that the design and planned analysis of the proposed Phase 3 trial adequately addresses the objectives necessary to support a regulatory submission. We initiated the pivotal Phase 3 trial in September of 2011 and expect to provide an update on the interim analysis which will be conducted by an Independent Data Monitoring Committee (IDMC) in the beginning of 2013.

We are working to broaden the applicability of TH-302 to other cancers and in combination with other approved anti-cancer drugs as well as to discover additional hypoxia activated prodrugs that will selectively target cancer cells.

We were incorporated in October 2001. We have devoted substantially all of our resources to research and development of our product candidates. We have not generated any revenue from the commercial sales of our product candidates, and prior to our initial public offering in February 2005, we funded our operations through the private placement of equity securities. During the quarter ended March 31, 2012, we sold 2,022,144 shares of common stock under our at market issuance sales facility for net proceeds of $12.3 million, and we received approximately $4.6 million from the exercise of warrants to purchase common stock. On February 3, 2012, we entered into an agreement with Merck KGaA, which provided for an upfront payment of $25 million. We also earned an additional $32.5 million in milestone payments, $20 million of which we have received subsequent to March 31, 2012 and the remaining $12.5 million is expected by the end of the 2012. We could receive an additional $22.5 million in potential milestone payments that are independent of continued development of TH-302 in pancreatic cancer in 2012. As of March 31, 2012 we had cash, cash equivalents and marketable securities of $49.7 million.

We expect to continue to devote substantial resources to research and development in future periods as we complete our current clinical trials, start additional clinical trials and continue our discovery efforts. Research and development expenses are expected to increase in 2012 compared to 2011 due to the continued execution of existing clinical trials and beginning of new clinical trials. We believe that our cash, cash equivalents and marketable securities will be sufficient to fund our projected operating requirements for at least the next twelve months based upon current operating plans, milestone payment forecasts and spending assumptions. We expect that we will need to raise additional capital to support new in-house development programs or to in-license or otherwise acquire and develop additional products or programs. We intend to seek funds through additional arrangements with collaborators or others that may require us to relinquish rights to certain product candidates that we might otherwise seek to develop or commercialize independently. Research and development expenses may fluctuate significantly from period to period as a result of the progress and results of our clinical trials.

Results of Operations

Revenue. We recognized a total of $0.3 million in the three months ended March 31, 2012 from the amortization of the $25 million upfront payment received and $32.5 million milestone payments earned payments, including a $20 million milestone payment based on positive results from its randomized Phase 2 trial in pancreatic cancer, from our collaboration with Merck. We are amortizing the upfront payment and milestones earned over the period of performance (product development period). We will periodically review and, if necessary, revise the estimated periods of performance of our collaboration. No revenue was recognized for the three months ended March 31, 2011.

Research and Development. Research and development expenses were $5.7 million for the three months ended March 31, 2012 compared to $6.1 million for the three months ended March 31, 2011. The $0.4 million decrease in expenses is due primarily to a $1.1 million reimbursement for Merck's 70% share of development expenses for TH-302, partially offset by $0.4 million increase in clinical development expenses and increase of $0.2 million in consulting and employee related expenses.

Three months ended
Research and development expenses by project (in thousands) March 31,
2012 2011
TH-302 $ 4,748 $ 5,119
Discovery research 947 978
Total research and development expenses $ 5,695 $ 6,097

Research and development expenses associated with our internally discovered compound TH-302 were $4.7 million for the three months ended March 31, 2012 and $5.1 million for the three months ended March 31, 2011. TH-302 continues to progress through the 406 trial, the 404 trial and the 403 trial. We reported top-line results for the 404 trial in February 2012 and detailed results in April 2012. We expect to provide additional overall survival data on the 404 trial in the second half of 2012.

Discovery research and development expenses were $0.9 million for the three months ended March 31, 2012 compared to $1.0 million for the three months ended March 31, 2011. We continue to focus our efforts towards discovering and developing new drug candidates from our hypoxia activated prodrug platform.

We did not track research and development expenses by project prior to 2003, and therefore we cannot provide cumulative project expenses to date. Due to the risks and uncertainties involved in discovering and developing product candidates, such as clinical trial results, regulatory approval requirements, dependence on third parties and market acceptance, which are described in the "Risk Factors" section in Part II of this Quarterly Report on Form 10-Q, we cannot reasonably estimate the costs and timing of completion of each project or when any project will result in net cash inflows.

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We expect to continue to devote substantial resources to research and development in future periods as we complete our current clinical trials, start additional clinical trials and continue our discovery efforts under our collaboration with Merck as well as on our own. Research and development expenses are expected to increase in 2012 compared to 2011 due to the continued execution of existing clinical trials and start of new clinical trials.

General and Administrative. General and administrative expenses were $1.7 million for the three months ended March 31, 2012, compared to $1.3 million for the three months ended March 31, 2011. The $0.4 million increase in expenses is due primarily to an increase in consulting expenses related to our collaboration with Merck KGaA. We currently expect our general and administrative expenses to increase in 2012 compared to 2011 due to increased staffing and consulting expenses to support our collaboration with Merck KGaA and the continued development of TH-302.

Interest Income (Expense), Net

Interest income (expense), net for the three months ended March 31, 2012 was $1,000 of interest income compared to $3,000 of interest income for 2011.

Other Income (Expense)

Other income (expense) for the three months ended March 31, 2012 was non-cash expense of $108.4 million compared to non-cash expense of $0.9 million, for the three months ended March 31, 2011. The increase in non-cash expense was due to an increase of $108.4 million in the fair value of outstanding warrants to purchase common stock as well as warrants exercised during the three months ended March 31, 2012. ASC 815 "Derivatives and Hedging" requires that stock warrants with certain terms need to be accounted for as a liability with changes to their fair value recognized in the consolidated statement of comprehensive loss.

Liquidity and Capital Resources

We have not generated and do not expect to generate revenue from sales of product candidates in the near term. Since our inception we funded our operations primarily through private placements and public offerings of equity securities. During the quarter ended March 31, 2012, we sold an aggregate of 2,022,144 shares of common stock under our at market issuance sales facility for net proceeds of $12.3 million, and we received approximately $4.6 million from the exercise of warrants to purchase common stock.

On February 3, 2012, we entered into an agreement with Merck KGaA, which provided for an upfront payment of $25 million, of which $21 million was received during the quarter ended March 31, 2012 and $4 million was received subsequent to March 31, 2012. We also earned a further $32.5 million in milestone payments, $20 million of which we received subsequent to March 31, 2012 and the remaining $12.5 million is expected by the end of 2012. We could receive an additional $22.5 million in potential milestone payments that are independent of continued development of TH-302 in pancreatic cancer in 2012. We had cash, cash equivalents and marketable securities of $49.7 million and $20.3 million at March 31, 2012 and December 31, 2011, respectively, available to fund operations.

Net cash provided by operating activities for the three months ended March 31, 2012 was $12.3 million compared to $6.0 in net cash used in operating activities for the three months ended March 31, 2011. The increase of $18.3 million in cash provided by operations was primarily attributable to $21 million of cash received related to an upfront payment from the Merck collaboration during the three months ended March 31, 2012.

Net cash used in investing activities for the three months ended March 31, 2012 was $9.5 million compared with net cash used in investing activities of $2.5 million for the three months ended March 31, 2011. The $7.0 million increase in cash used by investing activities was due primarily to the excess of proceeds used in the purchase of marketable securities over proceeds from the sales and maturities of marketable securities.

Net cash provided by financing activities for the three months ended March 31, 2012 and 2011 was $17.2 and $29.7 million, respectively. The $12.5 million decrease in cash provided by financing activities was primarily due to the approximately $27.8 million of net proceeds from our March 2011 registered direct offering as compared to the $17.2 million received during 2012 primarily as a result of our issuance of common stock under the at the market sales facility and the exercise of warrants to purchase shares of common stock.

Obligations and Commitments

We lease certain of our facilities under noncancelable leases, which qualify for operating lease accounting treatment under ASC 840, "Leases," and, as such, these facilities are not included on our unaudited condensed consolidated balance sheets.

During the three months ended March 31, 2012, there have been no significant changes in our payments due under contractual obligations and commitments, as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2011, which we filed with Securities and Exchange Commission ("SEC") on March 15, 2012.

At Market Sales Facility

On October 29, 2010, we entered into an at market issuance sales agreement, or sales agreement, with MLV & Co., LLC, formerly McNicoll, Lewis & Vlak LLC ("MLV"), pursuant to which we were able to issue and sell shares of our common stock having an aggregate offering price of up to $15.0 million from time to time through MLV as our sales agent. Sales of our common stock through MLV will be made on The NASDAQ Capital Market, on any other existing trading market for our common stock, to or through a market maker or as otherwise agreed

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by MLV and us. Subject to the terms and conditions of the sales agreement, MLV will use commercially reasonable efforts to sell our common stock from time to time, based upon our instructions (including any price, time or size limits or other customary parameters or conditions we may impose). We will pay MLV an aggregate commission rate of 3.0% of the gross proceeds of the sales price per share of any common stock sold under the sales agreement. Under certain circumstances, sales of the stock under the at market issuances sales agreement could result in an adjustment to the exercise price of certain of our outstanding warrants. The number of shares we are able to sell under this arrangement will be limited in practice based on the trading volume of our common stock. As of December 31, 2010 we had not sold any stock pursuant to the sales agreement. For the year ended December 31, 2011, we sold an aggregate of 971,037 shares of our common stock at an average price of $2.66 pursuant to the sales agreement. Net proceeds from the sale of stock in 2011 were $2.3 million. The sales of the stock did not result in an adjustment to the exercise price of certain of our outstanding warrants. Pursuant to an amendment to the at the market issuance sales agreement and a prospectus supplement we filed on January 20, 2012 and pursuant to a new registration statement filed with the Securities and Exchange Commission, we may sell shares of our common stock having an aggregate offering price of up to $15.0 million from time to time through MLV as our sales agent on the terms and conditions described above. During the three months ended March 31, 2012, we sold 2,022,144 shares of our common stock at an average price of $6.29 pursuant to the sales agreement. Net proceeds from the sale of stock were $12.3 million. The sale of stock did not result in an adjustment to the exercise price of certain of our outstanding warrants.

We believe that our cash, cash equivalents and marketable securities will be sufficient to fund our projected operating requirements for at least the next twelve months based upon current operating plans, milestone payment forecasts and spending assumptions. We expect that we will need to raise additional capital to in-license or otherwise acquire and develop additional products or programs. We intend to seek funds through additional arrangements with collaborators or others that may require us to relinquish rights to certain product candidates that we might otherwise seek to develop or commercialize independently.

We may seek to raise capital through a variety of sources, including:

the public equity market;

private equity financing;

collaborative arrangements;

licensing arrangements; and/or

public or private debt.

Our ability to raise additional funds will depend on our clinical and regulatory events, our ability to identify promising new in-house development programs or in-licensing opportunities, and factors related to financial, economic, and market conditions, many of which are beyond our control. We cannot be certain that sufficient funds will be available to us when required or on satisfactory terms. If adequate funds are not available, we may be required to significantly reduce or refocus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain of our products, technologies or potential markets, any of which could delay or require that we curtail our development programs or otherwise have a material adverse effect on our business, financial condition and results of operations. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities would result in ownership dilution to our existing stockholders.

In addition, our ability to raise additional capital may be dependent upon our stock being quoted on the NASDAQ Capital Market. If we are unable to secure additional financing on a timely basis or on terms favorable to us, we may be required to cease or reduce certain research and development projects, to sell some or all of our technology or assets or to merge all or a portion of our business with another entity. Insufficient funds may require us to delay, scale back, or eliminate some or all of our activities, and if we are unable to obtain additional funding, there is uncertainty regarding our continued existence.

Critical Accounting Policies and Use of Estimates

Our discussion and analysis of our financial condition and results of operations are based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses based on historical experience and on various assumptions that we believe to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. For further information on our critical accounting policies, see the discussion of critical accounting policies in our Annual Report on Form 10-K for the year ended December 31, 2011, which we filed with the SEC on March 15, 2012. There has been one material revision to the critical accounting policies as discussed in our Annual Report on Form 10-K for the year ended December 31, 2011 for the adoption of revenue recognition as a result of our entering into the collaboration with Merck in February 2012.

Revenue Recognition

We recognize revenue in accordance with ASC 605 "Revenue Recognition", subtopic ASC 605-25 "Revenue with Multiple Element Arrangements" and subtopic ASC 605-28 "Revenue Recognition-Milestone Method", which provides accounting guidance for revenue recognition for arrangements with multiple deliverables and guidance on defining the milestone and determining when the use of the milestone method of revenue recognition for research and development transactions is appropriate, respectively.

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Our revenues are related to our collaboration arrangement with Merck KGaA, which was entered in February 2012. Our collaboration with Merck provides for various types of payments to us, including non-refundable upfront license, milestone and royalty payments. We recognize revenue when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable, and collectability is reasonably assured. We will also receive reimbursement for Merck's 70% share for eligible worldwide development expenses for TH-302. Such reimbursement would be reflected as a reduction of operating expenses and not as revenue.

For multiple-element arrangements, each deliverable within a multiple deliverable revenue arrangement is accounted for as a separate unit of accounting if both of the following criteria are met: (1) the delivered item or items have value to the customer on a standalone basis and (2) for an arrangement that includes a general right of return relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially in our control. The deliverables under the Merck agreement have been determined to be a single unit of accounting and as such the revenue relating to this unit of accounting will be recorded as deferred revenue and recognized ratably over the term of its estimated performance period under the agreement, which is the product development period We determine the estimated performance periods, and they will be periodically reviewed based on the progress of the related product development plan. The effect of a change made to an estimated performance period and therefore revenue recognized ratably would occur on a prospective basis in the period that the change was made.

Deferred revenue associated with a non-refundable payment received under a collaborative agreement for which the performance obligations are terminated will result in an immediate recognition of any remaining deferred revenue in the period that termination occurred provided that all performance obligations have . . .

May 03, 2012

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os pongo el enlace pk no quedo bien..
http://www.marketwatch.com/story/10-q-threshold-pharmaceuticals-inc-2012-05-03