Compass Therapeutics, Inc. (CMPX): 5 FORCES Analysis [Nov-2025 Updated]

You're looking at a clinical-stage biotech, and honestly, the competitive landscape for Compass Therapeutics, Inc. as we hit late 2025 is a minefield of high stakes. We see supplier power creeping up-R&D spend hit \$42.3 million in the first nine months of 2025-while future customers, the big payers, are demanding near-perfect data for Tovecimig to justify any price tag in its niche market. Still, the sheer capital required to even play in oncology, evidenced by that \$50.8 million net loss over nine months in 2025, keeps the door mostly shut to new rivals, even as rivalry with established blockbusters remains intense. Dive in below to see how these five forces shape the near-term risk profile for CMPX.

Compass Therapeutics, Inc. (CMPX) - Porter's Five Forces: Bargaining power of suppliers

You're looking at the cost structure for Compass Therapeutics, Inc. (CMPX), and the supplier side is definitely a pressure point. For a clinical-stage biotech developing complex antibody-based therapeutics, the specialized nature of manufacturing and clinical testing means suppliers-like Contract Manufacturing Organizations (CMOs) and Clinical Research Organizations (CROs)-hold significant leverage. You can see this pressure clearly in the spending figures.

The financial reality for Compass Therapeutics, Inc. (CMPX) shows that development costs are escalating, which often translates to higher supplier power. Research and development expenses, which include crucial manufacturing steps, climbed 44% to $42.3 million for the first nine months of 2025, up from $29.3 million for the same period in 2024. That's a substantial jump in operational spend that you need to track.

Here's a quick look at how those R&D costs are stacking up as of late 2025:

The high reliance on specialized Contract Manufacturing Organizations (CMOs) for biologics is a major factor. When you're dealing with novel bispecific antibodies like tovecimig and CTX-10726, there aren't many facilities equipped to handle the production at clinical scale. The data shows that additional manufacturing expenses of $11.2 million were a key component of the nine-month R&D increase, suggesting that securing and paying for capacity with CMOs is costly. Plus, the Q1 2025 R&D increase of 37% to $13.1 million specifically cited manufacturing for tovecimig and CTX-10726 as a $2.5 million driver.

The power of these specialized suppliers is further evidenced by the cost associated with advancing candidates, which often involves Clinical Research Organizations (CROs) for late-stage trials. While the data directly points to manufacturing, the high overall R&D spend, including IND-enabling costs for CTX-10726 (IND filing planned for Q4 2025), suggests significant external service provider fees. The bargaining power of suppliers is high because Compass Therapeutics, Inc. (CMPX) needs these specific, high-cost services to hit its 2026 milestones, like the expected BLA filing in H2 2026. The company's strong cash position of $220 million as of September 30, 2025, with a runway extending into 2028, helps them absorb these costs, but it doesn't reduce the underlying supplier pricing power.

You can see the supplier-driven cost pressure in these specific areas:

• CMO costs for tovecimig and CTX-10726 are rising fast.
• IND-enabling costs for CTX-10726 are a new, significant spend area.
• The need for specialized, proprietary raw materials limits vendor choice.
• CRO fees for late-stage trials are inherently high in the biotech space.

Compass Therapeutics, Inc. (CMPX) - Porter's Five Forces: Bargaining power of customers

You're looking at the power payers have over Compass Therapeutics, Inc. (CMPX) as they move Tovecimig toward potential approval. Honestly, for a company this size, the customer base-meaning the payers-holds significant leverage, especially given the niche indication.

The power of future customers, which are the large government programs like Medicare and the major private insurers, is set to be extremely high. These entities control access and reimbursement rates, and they don't just pay sticker price for incremental benefit. They need to see clear, undeniable value to justify any premium pricing for a novel oncology agent.

This brings us directly to the data payers will demand for Tovecimig in advanced Biliary Tract Cancer (BTC). Payers will absolutely demand superior Overall Survival (OS) data. This isn't just a preference; the regulatory environment is pushing this way. The FDA released draft guidance in August 2025 that signals OS must be assessed in all randomized oncology studies supporting approval, treating it as a critical safety endpoint alongside efficacy. Compass Therapeutics, Inc. is currently banking on secondary endpoints, with OS and Progression-Free Survival (PFS) analyses for the Phase 2/3 COMPANION-002 trial expected in late Q1 2026. Until that data is in, payer negotiations are on hold, but the expectation for OS superiority over existing standards is the key hurdle.

The current efficacy data provides a baseline, but it's not OS. For context, Tovecimig previously hit its primary endpoint, showing a 17.1% overall response rate (ORR) compared to only 5.3% ORR for paclitaxel alone in the second-line BTC setting. That 17.1% ORR is the number payers will compare the future OS data against. If OS doesn't translate into a meaningful survival extension, the pricing power Compass Therapeutics, Inc. can command will be severely limited.

The small, niche target population for Tovecimig further limits Compass Therapeutics, Inc.'s volume leverage in negotiations. Claims-based market research indicates approximately ~25,000 patients are diagnosed with BTC annually in the United States alone, and Tovecimig is aimed at the second-line setting where few options exist. Low volume means payers can afford to be stricter on price per patient, as the total cost impact to their overall book of business is relatively contained compared to a broad-market drug.

Here's a quick look at the key data points shaping this dynamic:

The leverage held by strategic partners is another factor you need to watch. Until Compass Therapeutics, Inc. secures a drug near or post-approval-which is targeted for the second half of 2026-any existing partner, perhaps one contributing to development or manufacturing costs, holds high leverage. They have influence over commercialization terms, which directly impacts the net realized price after rebates and discounts negotiated with the payers. Right now, the company is investing heavily, with R&D expenses for the nine months ended September 30, 2025, at $42.3 million, up 44% year-over-year. This investment intensity means they need favorable terms when they finally get to the negotiating table.

The immediate power dynamics for Compass Therapeutics, Inc. can be summarized by these pressures:

• Payer focus: Demand for robust, statistically significant Overall Survival data.
• Market reality: Small patient pool means low volume leverage in price talks.
• Regulatory pressure: New August 2025 FDA guidance heightens OS scrutiny.
• Company strength: $220 million cash runway into 2028 offers a temporary buffer.

If onboarding takes 14+ days, churn risk rises, and similarly, if the OS data is delayed past Q1 2026, payer patience will definitely wear thin.

Compass Therapeutics, Inc. (CMPX) - Porter's Five Forces: Competitive rivalry

You're looking at the competitive landscape for Compass Therapeutics, Inc. (CMPX) right now, and honestly, it's a battleground. The oncology space is dominated by giants, and that puts immediate pressure on a clinical-stage company like this one.

Intense rivalry in oncology from large pharma with marketed blockbusters is the baseline reality here. The global blockbuster oncology brands market size was valued at $51.18 Billion in 2025, with companies like Merck & Co., Bristol Myers Squibb, Roche, and AstraZeneca actively expanding labels for their established immune-oncology drugs. These players have the resources to outspend and out-maneuver smaller firms in clinical development and commercialization, so Compass Therapeutics, Inc. needs to hit its milestones precisely.

Tovecimig, the company's lead asset, is directly challenging established chemotherapy, specifically paclitaxel, in the biliary tract cancer (BTC) setting. The data from the COMPANION-002 Phase 2/3 study shows a clear signal, but it needs to translate into survival benefit to truly compete. Here's the quick math on the primary endpoint:

Still, the competitive pressure is immense because Tovecimig is a DLL4 x VEGF-A bispecific antibody, placing it in a crowded field of next-generation therapies. Pipeline candidates target pathways already saturated with rivals, which means Compass Therapeutics, Inc. needs superior efficacy or safety to gain traction.

The pressure to win is amplified by the financial reality. Compass Therapeutics, Inc. reported a net loss of $14.3 million for the third quarter of 2025. That loss widened from $10.5 million in the same period in 2024, and the nine-month loss hit $50.8 million compared to $34.3 million the prior year. You defintely need to watch the burn rate when facing this level of competition.

The company is currently funded, holding $220 million in cash and marketable securities as of September 30, 2025, which provides an anticipated cash runway into 2028. That runway must cover the execution of several critical, time-sensitive pipeline events:

• CTX-10726 (PD-1 x VEGF-A bispecific) IND filing planned for Q4 2025.
• CTX-8371 cohort expansions in NSCLC and TNBC expected to begin in Q4 2025.
• Initial Phase 1 data for CTX-10726 expected in H2 2026.
• Top-line OS and PFS data for tovecimig expected in late Q1 2026.

The rivalry in the PD-1/VEGF bispecific space is particularly intense, with major players like Pfizer and Bristol Myers Squibb aggressively pursuing similar mechanisms, often with more advanced clinical data or larger partner backing. For Compass Therapeutics, Inc., every quarter without a clear commercial advantage or significant partnership increases the risk of being overshadowed by these larger rivals.

Compass Therapeutics, Inc. (CMPX) - Porter's Five Forces: Threat of substitutes

The threat of substitutes for Compass Therapeutics, Inc. (CMPX) products is substantial, rooted in existing, approved, and often more affordable treatment modalities across oncology indications.

Approved, cheaper, and established standard-of-care treatments are ready substitutes.

For indications like Biliary Tract Cancer (BTC), the established second-line chemotherapy regimen, FOLFOX, demonstrated a modest Overall Response Rate (ORR) of approximately 10% in a meta-analysis of patients progressing after first-line cisplatin/gemcitabine. In contrast, Tovecimig achieved an 17.1% ORR in its Phase 2/3 trial. Furthermore, the economic hurdle is high; for first-line advanced BTC, the addition of an immune checkpoint inhibitor to chemotherapy resulted in an Incremental Cost-Effectiveness Ratio (ICER) of USD 810,184.42 per QALY in the US scenario, indicating that established chemotherapy alone presents a significantly cheaper alternative on a per-QALY basis.

Existing immune checkpoint inhibitors (e.g., PD-1) are primary alternatives to bispecifics.

The market dominance of existing immune checkpoint inhibitors (ICIs) presents a major substitution threat. The global PD-1 & PD-L1 Inhibitors Market size was valued at USD 62.15 billion in 2025. PD-1 agents alone accounted for 81.51% of the 2024 market revenue. In Non-Small Cell Lung Cancer (NSCLC), a key area of oncology focus, the 5-year Overall Survival (OS) rate for patients receiving pembrolizumab plus chemotherapy was 19.4 months, compared to 11.3 months for placebo plus chemotherapy. For Renal Cell Carcinoma (RCC), established immunotherapy combinations like ipilimumab plus nivolumab continue to be supported as standard first-line therapy over older targeted agents like sunitinib.

Radiation and surgical options remain viable substitutes for solid tumor treatment.

For earlier-stage solid tumors, particularly NSCLC, local modalities offer curative intent and serve as strong substitutes to systemic therapies. For early-stage, operable NSCLC, a 10-year OS rate of 66% was reported for surgery. Stereotactic Ablative Radiotherapy (SABR) demonstrated a comparable 10-year OS rate of 69%. For unresectable, locally advanced Stage III NSCLC, concurrent chemoradiotherapy is the standard, yielding a median OS of 19.5 months and a 2-year OS rate of 38.8% in one study cohort.

Tovecimig's 17.1% ORR must translate to strong OS data to displace current regimens.

Compass Therapeutics, Inc. (CMPX) must demonstrate a meaningful advantage over existing options to overcome the inertia of established standards. Tovecimig's primary endpoint success in second-line BTC was an ORR of 17.1% (compared to 5.3% for paclitaxel alone). However, the data for the critical secondary endpoints, including Overall Survival (OS), are not yet mature, with top-line results expected in late Q1 2026. The ability of Tovecimig to significantly improve OS and Progression-Free Survival (PFS) over the established second-line regimen, FOLFOX (which showed a median OS just short of 6.5 months), will be the ultimate determinant of its ability to displace current standards.

The competitive landscape for Compass Therapeutics, Inc. (CMPX) is defined by the following efficacy benchmarks of substitute treatments:

The continued reliance on established modalities is supported by several factors:

• PD-1/PD-L1 inhibitors captured 81.51% of the 2024 market share.
• Concurrent chemoradiotherapy for unresectable Stage III NSCLC yielded a median OS of 19.5 months.
• The global PD-1 & PD-L1 Inhibitors Market reached USD 62.15 billion in 2025.
• For advanced BTC, FOLFOX showed a 12-month OS rate of 25.9% versus 11.4% for supportive care in the ABC-06 trial.
• Tovecimig's OS data is pending the achievement of 80% of pooled OS events, expected in late Q1 2026.

Compass Therapeutics, Inc. (CMPX) - Porter's Five Forces: Threat of new entrants

You're looking at the barriers to entry for a new player trying to muscle in on Compass Therapeutics, Inc.'s space. Honestly, for a clinical-stage biotech focused on complex antibody therapeutics, the hurdles are massive, which is good news for current shareholders.

Extremely High Capital Barrier

The sheer amount of capital required to even attempt to replicate what Compass Therapeutics, Inc. is doing is staggering. You need deep pockets just to survive the pre-revenue phase, let alone fund the necessary clinical trials. Compass Therapeutics, Inc. is burning cash to advance its pipeline, reporting a net loss of $50.8 million for the nine months ended September 30, 2025. That kind of sustained loss requires significant, continuous funding, which deters most newcomers immediately. Here's the quick math on the capital intensity we are seeing right now:

This table shows you the reality: developing novel biologics demands millions before you see a dollar of revenue. What this estimate hides is the future capital needed for Phase 3 trials and potential commercialization, which will be substantially higher.

Complex FDA Regulatory Pathway

The regulatory environment for novel bispecific antibodies acts as a significant, non-financial barrier. Getting a new molecular entity through the Food and Drug Administration (FDA) process is inherently difficult, but for complex, novel mechanisms like those Compass Therapeutics, Inc. is pursuing-such as their DLL4 x VEGF-A bispecific antibody tovecimig-the scrutiny is intense. New entrants face the same gauntlet of safety and efficacy hurdles, which translates to years of uncertainty and massive sunk costs.

Need for Proprietary Discovery Platforms

You can't just license a molecule; you need the engine to create the next one. Compass Therapeutics, Inc. relies on its proprietary, high-throughput multispecific antibody screening platform, StitchMabs™, to covalently link antibodies and screen bispecific concepts in large matrix experiments to find novel synergistic combinations. A new entrant would need to spend years and significant capital developing a comparable, validated discovery platform to compete on molecule generation speed and novelty. This technological moat is hard to cross.

• StitchMabs™ creates customized bi- and multispecific formats.
• Platform screens concepts in large matrix experiments.
• Enables rapid conversion of insights into therapeutic leads.
• Focuses on well-behaved, manufacturable candidates.

Cash Runway as a Temporary Shield

For now, Compass Therapeutics, Inc. has bought itself time. With $220 million in cash and marketable securities as of September 30, 2025, the company has an anticipated cash runway extending through 2028. This runway means they can fund operations and key clinical milestones-like the expected OS/PFS data for tovecimig in late Q1 2026 and the planned IND filing for CTX-10726 in Q4 2025-without immediate pressure to raise dilutive capital. Still, this shield is only temporary; if clinical progress stalls, the need for financing will return, potentially opening the door wider for better-funded competitors.