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Threshold Pharmaceuticals Inc.


Threshold Pharmaceuticals Inc. is a biotechnology company using its expertise in the tumor microenvironment to discover and develop therapeutic agents that selectively target tumor cells for the treatment of patients living with cancer. Threshold's lead investigational small molecule, TH-302, is being evaluated in two pivotal Phase 3 clinical trials and multiple earlier-stage clinical trials. The company has a global license and codevelopment agreement for TH-302 with Merck KGaA, with an option to co-commercialize in the United States.

The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.

Expert Comments:

Philippa Gardner, Edison Investment Research (11/18/14) "Additional interim data from the ongoing Phase 1/2 investigator-led trial of Threshold Pharmaceuticals Inc.'s TH-302 in glioblastoma (GBM) have been reported at the Society for Neuro-Oncology conference. Based on the early signs of efficacy observed. . .plans for an investigator-led, two-center Phase 2 trial have now been confirmed, supported by an FDA grant. GBM could be an indication eligible for accelerated development, given the unmet medical need. . .TH-302 has been partnered with Merck KGaA in a $525M deal and has potential across a broad range of tumors, with Phase 3 trials in both soft tissue sarcoma and pancreatic cancer ongoing."

Charles Duncan, Piper Jaffray & Co. (11/17/14) "Data were presented over the weekend at the Society for Neuro-Oncology meeting from the investigator-sponsored Phase 1/3 trial for Threshold Pharmaceuticals Inc.'s TH-302 plus Avastin in treating Avastin-refractory glioblastoma multiforme. The data look positive to us, with one complete response and three partial responses from 22 evaluable patients (18% response rate)."

Andrew Fein, H.C. Wainwright & Co. (11/12/14) "Threshold Pharmaceuticals Inc. continues to diversify and build value beyond pivotal indications. For a company whose two main binary value catalysts are over a year ahead (TH-302 pivotal readouts from sarcoma and pancreatic cancer likely both in Q1/16), we believe that Threshold has done a remarkable job staying active by building new value through both business development and pipeline expansion."

The Life Sciences Report Interview with George Zavoico (11/12/14) "Threshold Pharmaceuticals Inc., which is targeting hypoxia, a characteristic of many solid tumors and some blood cancers. The company has a couple of near-term milestones. At the Society for Neuro-Oncology in mid-November, Threshold plans to present some TH-302 (hypoxia-activated chemotherapeutic prodrug) data from a glioblastoma study. Then, in early December at the American Society of Hematology meeting, it is presenting further data on multiple myeloma. Threshold has two Phase 3 trials going on with TH-302 in sarcoma and pancreatic cancer, which should read out by the end of 2015 or early 2016. It also has a number of ongoing investigator-sponsored trials (ISTs).

Back on Oct. 9 the company did something interesting: It licensed a hypoxia-activated epidermal growth factor receptor tyrosine-kinase inhibitor (EGFR-TKI), called hypoxin. . .it's been shown to induce tumor cell death in erlotinib-resistant non-small cell lung cancer (NSCLC). It could be used in combination with another EGFR-TKI to get broader activity; the targeted agent would kill the tumor cells nearest the tumor blood vessels, while the hypoxia-activated prodrug would kill cells in more hypoxic regions, farther away from blood vessels. You could potentially get more efficient tumor killing. . .Threshold is doing preclinical studies to see whether the theory might play out. . .I would very much like to see Threshold advance the EGFR-TKI prodrug further because it would be the logical next step in the company's platform, and in introducing a new class of agents, targeted hypoxia-activated prodrugs. . ." More >

Jerry Isaacson, LifeSci Advisors (11/7/14) "Threshold Pharmaceuticals Inc.'s partner Merck KGaA has completed enrollment in the MAESTRO Phase 3 trial. . .completing target enrollment of 660 patients ahead of schedule indicates strong patient interest in finding new pancreatic cancer therapies."

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Charles Duncan, Piper Jaffray & Co. (11/4/14) "Threshold Pharmaceuticals Inc.'s Q3/14E cash was $68M, and we project this is sufficient at least into 2016. . .the company also announced it has licensed Hypoxin (aka PR610), a hypoxia-activated epidermal growth factor receptor inhibitor. . .we expect to see updates on the agent's activity and possibly the initiation of a Phase 2 in molecularly defined nonsmall cell lung cancer in H1/15."

George Zavoico, MLV & Co (10/13/14) "Based on our long-term revenue and expenses projections, and if development of drug candidates in Threshold Pharmaceutical Inc.'s pipeline proceeds without any significant delays, unfavorable trial results, or other negative surprises, we think the company could become profitable in 2016 based on revenue from sales of TH-302, its leading drug candidate, for the treatment of pancreatic cancer and soft tissue sarcoma."

Philippa Gardner, Edison Investment Research (9/24/14) "The conclusion of the interim efficacy and safety analysis of Threshold Pharmaceuticals Inc.'s ongoing Phase 3 soft tissue sarcoma (STS) trial is for the study to continue as planned, in line with both our and management's expectations. Based on the current event rate, the number of events (n=434 deaths) required for the primary efficacy analysis is expected to be reached in H2/15; STS could be the first approved indication for TH-302."

Andrew Fein, H.C. Wainwright & Co. (9/23/14) "Yesterday, in line with our expectations, the Independent Data Monitoring Committee (IDMC) recommended the continuation to completion of Threshold Pharmaceuticals Inc.'s Phase 3 study of TH-302 as a front-line doxorubicin add-on in advanced/metastatic soft tissue sarcoma. . .we regard the IDMC green light positively, as the study now continues towards its event-driven destination."

Charles Duncan, Piper Jaffray & Co. (9/22/14) "Threshold Pharmaceuticals Inc. announced today that the interim review at 50% events for its Phase 3 trial of TH-302 in soft tissue sarcoma (STS) has been completed, with the independent data monitoring committee concluding the trial should proceed as planned. . .the company updated data timing to H2/15 based on the observed event rate, later than previously projected. . .we look to the H2/15 readout in STS and pancreatic cancer data in H1/16 to establish TH-302 as a new paradigm in targeted chemotherapy and validate Threshold's hypoxiaactivation platform, and reiterate our Overweight rating and $13/share price target on the company."

Jerry Isaacson, LifeSci Advisors (9/15/14) "We are initiating coverage on Threshold Pharmaceuticals Inc. The company's lead molecule, TH-302, is partnered with Merck KGaA, Darmstadt, Germany, and is currently being evaluated in two Phase 3 trials for soft tissue sarcoma and pancreatic cancer patients."

Andrew Fein, H.C. Wainwright & Co. (9/5/14) "We are initiating coverage on Threshold Pharmaceuticals Inc. with a Buy rating and a price target of $12. . .we expect the company's shares to perform well into 2015, as a stream of preclinical and clinical updates at the major oncology meetings in H2/14 (European Society for Medical Oncology, EORTC, American Society of Hematology) first continues to sensitize investors on the wide applicability of TH-302 in oncology and then focuses their attention on the value-driving readout of the sarcoma and pancreatic cancer pivotal studies in mid-2015 and early 2016, respectively."

Grant Zeng, Zacks Small-Cap Research (8/4/14) "We model Threshold Pharmaceuticals Inc.'s TH-302 to be approved by the U.S. Food and Drug Administration in 2016 for soft tissue sarcoma; the company will be cash flow positive in 2018. Its balance sheet remains strong; we rate Threshold Outperform based on its strong fundamentals." -Zacks Small-Cap Research

Charles Duncan, Piper Jaffray & Co. (8/1/14) "Threshold Pharmaceuticals Inc. announced Q2/14 earnings this morning, with the most important news item, in our view, being an update on timing for an interim safety/efficacy look at the Phase 3 for TH-302 in soft tissue sarcoma, now expected in September. . .we reiterate our $13 price target on the company in light of this important milestone for a clinical agent we continue to view as novel and mechanistically sound."

Philippa Gardner, Edison Investment Research (7/14/14) "Threshold Pharmaceuticals Inc. and partner Merck KGaA have initiated a large Phase 2 trial investigating TH-302 as second-line treatment for lung cancer. This follows earlier-stage data where TH-302 in combination with Alimta (pemetrexed) achieved 14.9-month overall survival."

Tony Schwartz, Seeking Alpha (7/8/14) "Threshold Pharmaceuticals Inc. initiated a Phase 2 trial with TH-302 for the treatment of advanced nonsquamous nonsmall cell lung carcinoma. . .the addition of this trial to its pipeline along with the backing of a Merck KGaA partnership reiterates the potential of this undervalued company."

Philippa Gardner, Edison Investment Research (6/11/14) "Threshold Pharmaceuticals Inc.'s enterprise value of only about $173M seems undemanding given TH-302 has potential across a broad range of tumors, with Phase 3 trials in soft tissue sarcoma and pancreatic cancer ongoing, which could be blockbuster opportunities. As part of the 2012 $525M deal with Merck KGaA, Threshold could be entitled to a further $170M development and $245M sales-related milestones, in addition to double-digit royalties."

Echo He, Maxim Group (6/3/14) "During the 2014 American Society of Clinical Oncology annual meeting, Threshold Pharmaceuticals Inc. presented data on TH-302 in recurrent glioblastoma in combination with Avastin (bevacizumab) and relapsed/refractory multiple myeloma (MM). Preliminary MM data may lead to an expanded trial."

Charles Duncan, Piper Jaffray & Co. (6/3/14) "At this year's American Society of Clinical Oncology meeting, Threshold Pharmaceuticals Inc. provided a good update on the early, but increasingly interesting, programs for TH-302 in multiple myeloma and glioblastoma multiforme. . .these programs are becoming increasingly visible and the platform beyond soft tissue sarcoma and pancreatic cancer contributes a not-insignificant $4/share to our price target."

Philippa Gardner, Edison Investment Research (5/23/14) "Data from Threshold Pharmaceuticals Inc.'s ongoing Phase 1/2 glioblastoma and a Phase 1/2 multiple myeloma trial will be presented at the American Society of Clinical Oncology meeting on May 30. These could be eligible for accelerated development, given the unmet medical need."

Jerry Isaacson, LifeSci Advisors (5/14/14) "Threshold Pharmaceuticals Inc. will present two abstracts at the 2014 American Society of Clinical Oncology meeting May 30-June 3. . .an upcoming milestone in mid-2014 is completion of events required for interim analysis of the Phase 3 study with TH-302 in soft tissue sarcoma."

Charles Duncan, Piper Jaffray & Co. (5/2/14) "Threshold Pharmaceuticals Inc. ended Q1/14 with ~$86M in cash and management guided to at least 12 months of operating runway. We model the company as fully funded through at least 2015. . .most investors are likely focused on the Phase 3 sarcoma interim, still expected mid-2014 with data released we think most probably in Q3/14."

The Life Sciences Report Interview with Charles Duncan (4/24/14) "Threshold Pharmaceuticals Inc. is an oncology innovator that has partnered with Merck KGaA . . .it has a very innovative platform focusing on hypoxia-activated drugs for oncology. These drugs have a warhead or payload of chemotherapy attached that is activated within a low-oxygen (i.e., hypoxic) environment, which is a property of all solid tumors and some hematologic marrow cancers. In solid tumors this condition is characteristic because an established tumor may be walled off in tissue that is not well vascularized.

A drug that is only activated in that kind of environment could be pretty interesting because it could deliver a relatively higher concentration of chemotherapy into a tumor mass. This could result in greater efficacy. And when you think about it, it could also result in a reduced side-effect profile because a physician might be able to eliminate or reduce some of the systemic delivery of the chemotherapy. . ." More >

The Life Sciences Report Interview with George Zavoico (3/6/14) "I think the momentum for Threshold Pharmaceuticals Inc. is building. There hasn't been a lot of new clinical data with TH-302 recently to keep the level of interest high in this stock, but through the course of this year and as we approach the announcement of the sarcoma data, I think we'll see interest reemerge in this name. I believe Threshold's drug works. Phase 2 trial data of TH-302 in combination with other chemotherapeutic agents are compelling. The drug seems to enhance efficacy of existing drugs in the first-line setting in a number of cases. . .results of a number of phase 1 and 2 trials in patients with multiple myeloma, renal cell cancer and glioma are expected this year." More >

The Life Sciences Report Interview with George Zavoico (8/15/13) "I'm enthusiastic about Threshold Pharmaceuticals Inc. because it's a pipeline in a drug. Its leading drug candidate, a hypoxia-activated prodrug called TH-302, is being evaluated in nine phase 1, 2 and 3 ongoing trials right now, in a variety of cancer indications both as monotherapy and in combination with other agents.

Threshold just started a phase 2 trial of TH-302 as monotherapy in advanced melanoma early this month and has guided to starting a 10th trial in an as-yet undisclosed indication that will be registrational. This would be its third pivotal trial: The first two are in soft tissue sarcoma (in combination with doxorubicin) and pancreatic cancer (in combination with gemcitabine). Before the end of the year, updated results from up to five ongoing trials may be presented at medical conferences. Positive results, even if in only two or three of these trials, would underscore the broad potential for this drug in oncology, and serve as a catalyst for the stock." More >

The Life Sciences Report Interview with Echo He (5/23/13) "Threshold Pharmaceuticals Inc. was able to show a statistically significant progression-free survival benefit in a phase 2 trial with TH-302 (a hypoxia-activated chemo prodrug). But the trial did not show an overall survival benefit, and that dented investors' confidence in the company and its drug. Threshold's phase 3 trial has a much cleaner design than the phase 2 study. Also, Threshold has partnered with German company Merck KGaA, and just the fact that Merck decided to go with a phase 3 gives some support to the theory Threshold has a good shot at pancreatic cancer with TH-302. . .

Some recent competitor's failures give TH-302 more chance to succeed in the market once it has achieved positive results. Also, with all these failures, some in earlier trial phases, I would say it is already encouraging that TH-302 was able to carry over to phase 3 trials." More >

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