TREK Therapeutics (TREKtx) positions itself as a Public Benefit Corporation (PBC) aiming to develop affordable infectious disease drugs, specifically targeting the Hepatitis C (HCV) market. The 2016 deck highlights the unsustainable pricing of current treatments, such as Gilead's Harvoni, which costs between $45,000 and $95,000 per regimen. TREK's strategy centers on TD-6450, a third-generation NS5A inhibitor licensed from Theravance Biopharma, and Faldaprevir. The deck provides detailed clinical data, including a comparison of replicon IC50s across various genotypes and dose-dependent antivi…
Key takeaways
- The company operates as a Public Benefit Corporation (PBC) with a mission to make infectious disease drugs affordable for all (Slide 1).
- TREK leverages a clinical advisory board with 18 members from global institutions including Mount Sinai, Johns Hopkins, and Peking University (Slide 3).
- The core problem identified is the 'Sovaldi Tax,' noting that 120 million patients outside the US cannot afford current HCV treatments (Slide 5).
- Lead asset TD-6450 is a third-generation NS5A inhibitor with a 60-66 hour half-life, supporting once-daily (QD) dosing (Slide 9).
- Clinical data shows TD-6450 is highly potent against GT4, with an IC50 of 0.004 nM, outperforming several competitors in that specific genotype (Slide 11).
- Phase 2a study results for TD-6450 demonstrated that 100% of GT1a patients achieved at least a 3 log10 reduction in HCV RNA across all tested doses (Slide 13).
- The regulatory strategy emphasizes speed, highlighting that the FDA approved their first IND protocol in just 7 days (Slide 17).
- The deck omits a formal 'Ask' slide, financial projections, and a specific timeline for commercial launch or exit (Slide 1-20).
Executive Summary and Mission
Slide 1: Title Slide
The deck opens with the TREK Therapeutics, PBC (TREKtx) logo and the subtitle "Confidential Comprehensive Slide Deck." The presence of the "PBC" designation is critical, as it identifies the company as a Public Benefit Corporation. The footer contains the company's mission statement: "Making infectious disease drugs for all." This sets the stage for a social-impact-driven pharmaceutical play, which is a distinct positioning compared to traditional biotech firms.
Slide 3: Clinical Advisory Board
TREK presents a "Distinguished Clinical Advisory Board" featuring 18 individuals. The list is geographically diverse, including representatives from the USA (Mount Sinai, Johns Hopkins, UMASS), China (Peking University), Germany (Hannover Med School), and Malaysia. Highlighting a board of this scale early in the deck serves to validate the scientific credibility of the venture, especially for a company focused on global health issues like Hepatitis C.
The Market Problem: The "Sovaldi Tax"
Slide 5: HCV Treatments are "Breaking the Bank"
This slide serves as the "Problem" slide. It uses a Forbes article headline to describe the "Sovaldi Tax" and quotes Steven Miller, CMO of Express Scripts, stating that current drug pricing will "break the country." The slide lists specific figures: Harvoni is sold for $45,000-$95,000 per regimen, and there are 3 million HCV patients in the US. Crucially, it identifies a massive underserved market of ~120 million patients ex-US who cannot afford current treatments. This defines the company's target market as the global population excluded by high-margin Western pricing models.
Asset Overview and Clinical Data
Slide 7: Asset Overview Transition
A simple transition slide marking the shift from the market problem to the company's specific pharmaceutical solutions.
Slide 9: TD-6450 Product Profile
This slide introduces TD-6450, a third-generation NS5A inhibitor originally developed by Theravance Biopharma. Key technical details include its high potency, excellent bioavailability as a powder in a capsule, and a half-life (T1/2) of 60-66 hours, which supports once-daily (QD) dosing. The slide also mentions that TREK is investigating a long-acting injectable formulation and co-formulation with FDV (Faldaprevir). This indicates a focus on patient adherence and treatment flexibility.
Slide 11: Competitive Potency Analysis
Slide 11 provides a highly technical comparison of NS5A Inhibitors' Replicon IC50s (nM) across five genotypes (GT1a through GT4). The table compares TD-6450 against drugs from Achillion, Merck, Gilead, BMS, and Presidio. TD-6450 shows particularly strong results in GT4 (0.004 nM) and GT1a/1b (0.006 nM). The slide concludes that TD-6450 plus FDV is expected to confer high Sustained Virologic Response (SVR) rates in GT1 and GT4, positioning it as a top-tier clinical contender.
Slide 13: Antiviral Activity Results
This slide presents data on TD-6450’s dose-dependent antiviral activity. In a study of GT1a patients (N=7 per dose group), 100% of patients achieved at least a 3 log10 reduction in HCV RNA across 60mg, 120mg, and 240mg doses. At the 240mg dose, 57% of subjects reached levels below the Limit of Detection (LOD). This data is intended to prove the drug's efficacy in humans, moving beyond theoretical replicon potency to actual clinical outcomes.
Slide 15: Faldaprevir (PI) Transition
A transition slide for Faldaprevir, a Protease Inhibitor (PI) that TREK is using as part of its combination therapy. While the specific details of Faldaprevir are not in the provided slides, its inclusion in the "Asset Overview" section suggests it is a core component of their treatment cocktail.
Clinical Strategy and Regulatory Progress
Slide 17: Clinical Strategy: Speed and Efficiency
TREK emphasizes its regulatory advantages, noting that the clinical strategy is "dynamic" to allow for further acquisitions. The standout metric here is that TREKtx received favorable feedback on its first protocol from the FDA in only 7 days. They attribute this speed to "well-characterized assets" and a "deeply experienced management team." This slide is designed to de-risk the investment by showing a clear and efficient path through the FDA.
Slide 19: Phase 2a Study Details
The final slide in this set details the first Phase 2a study, which started in the US in October 2015. The study's purpose was dose selection for TD-6450 to support future Phase 2b/3 studies in Egypt. Key trial parameters included a 120 mg FDV QD base, with TD-6450 dosed at 60 mg and 120 mg. The slide notes that the FDA did not require a separate DDI (Drug-Drug Interaction) study or a placebo arm, further reinforcing the theme of regulatory efficiency.
What TREK Therapeutics Does Well
The deck is exceptionally strong on clinical validation. By providing side-by-side IC50 comparisons against industry giants like Gilead and Merck, TREK makes a data-driven case for why their drug is scientifically competitive. The focus on Genotype 4 (GT4) is a smart niche strategy, as it targets regions like Egypt where HCV prevalence is high but affordability is low. Furthermore, the use of third-party validation—such as the Forbes article and quotes from insurance executives—effectively frames their mission not just as a social good, but as a market necessity.
What is Missing from the Deck
Despite the strong clinical data, the deck has several glaring omissions typical of early-stage biotech pitches that focus too much on the science and not enough on the business. First, there is no "Ask" slide. An investor finishing this deck would not know how much capital the company is seeking or what the valuation expectations are. Second, the "Management Team" slide is missing from this selection; while a board is listed, the day-to-day operators are not profiled. Third, the business model for a Public Benefit Corporation is not explained. Investors need to know how TREK plans to price the drug to be "affordable" while still providing a return on investment. Finally, there is no timeline or roadmap showing the path to commercialization or potential exit opportunities (e.g., IPO or acquisition).
Founder Takeaways: What to Copy
Niche Genotype Targeting: If you are entering a crowded market, follow TREK's lead by showing superior data in a specific sub-segment (like GT4) that incumbents might be overlooking. · Regulatory Wins as Traction: Mentioning a 7-day FDA turnaround is a powerful way to demonstrate "soft traction" in a field where progress is usually measured in years. · Comparative Data Tables: Slide 11 is a masterclass in competitive analysis. It doesn't just say "we are better"; it shows the exact nanomolar potency levels compared to every major rival. · Mission-Driven Branding: The PBC status and the "drugs for all" footer create a consistent narrative that differentiates the company from "Big Pharma," which can be a compelling hook for impact investors.
Frequently asked questions
- What is the primary value proposition of TREK Therapeutics?
- TREK Therapeutics positions itself as a disruptor in the Hepatitis C market by focusing on affordability. They argue that current treatments like Harvoni, priced up to $95,000, are unsustainable for the 120 million patients globally who need them. By developing well-characterized assets like TD-6450 and Faldaprevir, they aim to provide effective clinical outcomes at a price point that healthcare systems and international markets can actually support.
- How does TD-6450 compare to existing drugs from Merck and Gilead?
- According to Slide 11, TD-6450 shows competitive potency across multiple genotypes. In GT1a, its IC50 of 0.006 nM is comparable to Merck's Elbasvir (0.004 nM) and superior to Gilead's Ledipasvir (0.034 nM). Notably, in GT4, TD-6450's IC50 of 0.004 nM is significantly more potent than Gilead's Ledipasvir (0.11 nM) and Presidio's PPI-668 (0.05 nM).
- What is the status of TREK's clinical trials as of this deck?
- The deck indicates that TREK is in the mid-clinical stage. Slide 19 notes that a Phase 2a study for Genotype 4 (GT4) started in the US in October 2015. This study was designed for dose selection to support future Phase 2b/3 studies in Egypt. The company also mentions that formulation optimization for TD-6450 is ongoing, including the investigation of a long-acting injectable version.
- Who is behind the clinical development at TREK?
- While the management team is mentioned as 'deeply experienced' on Slide 17, their individual bios are not provided in the 10 slides shown. However, the company boasts a massive Clinical Advisory Board on Slide 3, featuring 18 experts from the US, France, Brazil, UK, Canada, Argentina, Malaysia, China, and Germany, suggesting a strong global network for clinical trials.
- What are the biggest risks or omissions in this pitch deck?
- The most significant omission is the lack of a financial 'Ask' and a clear business model for how a Public Benefit Corporation will generate returns for investors while maintaining low prices. There is no mention of the total capital raised to date, the amount currently sought, or the specific milestones that the next round of funding will achieve. The deck is heavily focused on clinical data rather than commercial execution.
