Below are some key notes and slides as described by speaker: Dr. Barry Selick, Chief Executive Officer of Threshold Pharmaceuticals (THLD), at the Jefferies Healthcare Conference in NY on June 6, 2012.
Threshold Pharmaceuticals' highlights to investors showed that the company's TH-302 is a novel small molecule hypoxic prodrug and is, quite frankly, the most advanced molecule of its type in development to target an unmet need in battling cancer. The CEO discussed that TH-302 provided positive results from Phase 2 pancreatic cancer clinical trial. Also, the international randomized, controlled Phase 3 clinical trial was initiated in September 201, and is being conducted in partnership with the Sarcoma Alliance for Research through Collaboration (SARC). SARC is a non-profit organization dedicated to the development and support of clinical trial research for the prevention, treatment and cure of sarcomas; a cancer of the bone and connective tissue of the body.
This company has some significant partnerships, which includes a worldwide co-development and co-commercialization deal in place with Merck KGaA (MRK). Under the terms of the agreement, Merck will receive co-development rights, exclusive global commercialization rights and will provide Threshold an option to co-commercialize the therapeutic in the United States. In exchange, Threshold will receive an upfront payment of $25 million and could receive up to $35 million in additional development milestones during 2012. Threshold is also eligible to receive total potential milestone payments of $525 million, comprised of $280 million in regulatory and development milestones and $245 million in sales-based milestones.
In the United States, Threshold will have primary responsibility for development of TH-302 in the soft tissue sarcoma indication. Threshold and Merck KGaA will jointly develop TH-302 in all other cancer indications being pursued. Merck KGaA will pay 70% of worldwide development costs for TH-302.
Subject to FDA approval in the United States, Merck KGaA will initially be responsible for commercialization of TH-302 with Threshold receiving a tiered, double-digit royalty on sales. Under the royalty-bearing portion of the agreement, Threshold retains the option to co-promote TH-302 in the United States. Additionally, Threshold retains the option to co-commercialize TH-302, allowing the company to participate in up to 50% of the profits in the United States based on certain revenue tiers. Outside of the United States, Merck KGaA will be solely responsible for the commercialization of TH-302 with Threshold receiving a tiered, double-digit royalty on sales in these territories.
Below are a few select slides that were presented at the conference. The ultimate takeaway here is that the company's prodrug TH-302 is working without major side effects. It has been shown to be increasing in efficacy and is safe, as well as having multiple uses in the battle against a number of types of cancers.
Benchmarking Shows Increased Efficacy
Threshold's Portfolio Pipeline Is Very Strong
TH-302 US and EU Market Opportunity Summary
Current Events And Future Catalysts Pending
The consistency of activity of TH-302 across multiple indications in monotherapy and in combinations is "Striking" as expressed by the CEO. The expectations of Overall Survival (O/S) in the pancreatic trials should meet or exceed expectations / goals. The TH-302 combinations are "well tolerated," showing safety and increase efficacy in patients. Specifically, TH-302 adds to the efficacy of gemcitabine in first-line pancreatic cancer with "statistically significant improvements." There was "no" organ related toxicity.
Several slides were presented showing that real tumors in the patients are showing a reduction in size. Threshold's capability and worldwide reach have been greatly enhanced with the partnership of Merck KGaA. With Merck's periodic milestone payments and no debt, the company is very financially strong. The company's broad portfolio, including the drug TH-302, has huge worldwide potential in the treatment of "a variety of cancers."
So, what's a good idea or product with the right leadership to execute the strategies? Well, in this case, management is very strong with a wealth of biotech experience, and we should expect several upcoming milestones and news announcements in the coming weeks/months.
Current stock price is around $6.50
12 month target projection: Rage from $12 - $15 on positive trial news
To read more about Threshold Pharmaceuticals, please refer to this article that includes more in depth analysis about the company's potential blockbuster drug capability.