Processa Pharmaceuticals, Inc. (PCSA): Business Model Canvas [Dec-2025 Updated]

Honestly, you're looking at a classic clinical-stage biotech model for Processa Pharmaceuticals, Inc. (PCSA), but with a few fascinating financial twists as of late 2025. They are driving forward three key pipeline assets-NGC-Cap, PCS499, and PCS11T-while funding an operating burn that hit about $3.48 million in Q3 2025 through equity raises netting $10.6 million in the first nine months of the year, plus they are actively managing a corporate cryptocurrency treasury valued at $850,000. The real leverage point, though, is the out-licensing of PCS12852, a deal potentially worth up to $454 million in milestones, so check out the full canvas below to see exactly how this tightrope walk between drug development and capital diversification is mapped out.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Key Partnerships

Processa Pharmaceuticals, Inc. relies on several external entities to execute its clinical development, financial, and corporate strategy as of late 2025.

The monetization of non-core assets involves a significant partnership for PCS12852.

Clinical trial execution for the core oncology pipeline, specifically the Phase 2 adaptive design trial for PCS6422 (NGC-Cap) in metastatic breast cancer, depends on Contract Research Organizations (CROs) managing the multicenter study.

• The PCS6422 Phase 2 trial is a global, multicenter, open-label study enrolling approximately 60 to 90 patients.
• Initial data readout from this Phase 2 trial was anticipated in the second half of 2025.

For corporate finance and treasury strategy, Processa Pharmaceuticals, Inc. has brought in specialized external advice.

• Processa Pharmaceuticals, Inc. engaged LifeSci Capital, LLC in an advisory capacity in connection with implementing its corporate cryptocurrency treasury strategy, announced on August 7, 2025.
• This engagement supports the evaluation of blockchain-based assets to diversify capital and enhance financial flexibility.

Investor relations and public communication are managed through a contracted service provider, with specific financial terms agreed upon in 2025.

RedChip Companies, Inc. provides investor awareness services under a defined agreement.

• The agreement stipulated a $10,000 monthly cash fee, beginning in April 2025.
• The agreement also included 50,000 shares of PCSA Rule 144 stock for 6 months of service.
• Investor Relations contact is available via the email address PCSA@redchip.com.

Engagement with Key Opinion Leaders (KOLs) and academic research institutions is implicit in the clinical trial structure, with Processa Pharmaceuticals, Inc.'s own R&D leadership presenting data, such as Dr. David Young, President of Research & Development, at the 2025 ASCO Annual Meeting. Furthermore, the partner entity Intact Therapeutics originated as a spinout from Stanford University. The development team members have been involved with more than 30 drug approvals by the FDA and more than 100 FDA meetings throughout their careers.

Finance: review the cash flow impact of the $2.5 million option exercise fee from Intact Therapeutics by next week.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Key Activities

You're managing a clinical-stage pipeline, so your key activities are all about execution, strategic monetization, and prudent capital management to keep the science moving forward. Here's the breakdown of what Processa Pharmaceuticals, Inc. (PCSA) was actively driving as of late 2025.

Conducting the Phase 2 adaptive trial for NGC-Cap (PCS6422) in metastatic breast cancer

The lead oncology asset, NGC-Cap (PCS6422) in combination with capecitabine, is the current focus of clinical operations. This is a global multicenter, open-label, adaptive design trial. The trial is designed to compare two different doses of NGC-Cap against the FDA-approved monotherapy capecitabine. You were expecting the remaining patients needed for the pre-planned interim analysis to be enrolled in the second half of 2025. This trial builds on earlier Phase 1b findings, which demonstrated that NGC-Cap provided up to 5-10 times greater 5-FU exposure to cancer cells. For the nine months ending September 30, 2025, Research and Development (R&D) expenses were higher year-over-year, but the third quarter (Q3) 2025 R&D spend specifically was $1.66 million, showing a decrease of $626,000 from the prior year, reflecting cost adjustments associated with the ongoing trials.

• Trial patient target: approximately 60 to 90 patients.
• Initial data readout anticipated in the second half of 2025.
• The trial is identified by the NCT number NCT06568692.

Developing the regulatory strategy for PCS499, including a planned FDA meeting for Phase 3 design

For PCS499, which targets rare kidney diseases like Focal Segmental Glomerulosclerosis (FSGS), the activity is centered on regulatory planning. You are actively working toward discussing an adaptive Phase 2/3 design with the FDA later in 2025. This is a critical step to accelerate the path toward regulatory approval for a drug with a favorable safety profile over pentoxifylline (PTX). The data supporting this design was scheduled for presentation at the American Society of Nephrology (ASN) Kidney Week between November 5-9, 2025, in Houston, Texas. The abstract for the adaptive Phase 2/3 study was accepted for presentation on Friday, November 7, 2025. Honestly, the planning for the Phase 3 trial for PCS499 in FSGS is the near-term regulatory milestone, even though a prior FDA meeting in March 2020 established a Phase 3 plan for Necrobiosis Lipoidica (NL) ulcers.

Strategic business development, including licensing non-core assets like PCS12852

Monetizing non-oncology assets is a key activity to bolster the balance sheet and focus resources. The binding term sheet for PCS12852 with Intact Therapeutics is a prime example. This deal structure is quite detailed, and you need to track the cash flow carefully, especially the pass-through obligation. You must remember that Processa must share 60% of any cash payments received with its original licensor. Still, retaining a 3.5% equity stake in Intact aligns you for future upside.

Here's the quick math on the potential value unlocked from PCS12852:

This strategic move followed a reported capital infusion of $7 million around July 2025, helping to strengthen the balance sheet.

Managing and expanding the corporate cryptocurrency treasury for capital diversification

Processa Pharmaceuticals is definitely exploring emerging financial technologies to support development without immediate dilution. You announced the evaluation of corporate cryptocurrency treasury strategies in August 2025. The plan involves evaluating select blockchain-based assets that have potential yield-generating capabilities. LifeSci Capital, LLC was engaged in an advisory capacity to help implement this strategy. This financial activity is happening while the company is actively raising capital through traditional means; for the first nine months of 2025, Processa raised net proceeds of $10.6 million through public offerings. As of September 30, 2025, the cash and cash equivalents on the balance sheet totaled $6.3 million.

Ongoing preclinical research for NGC-Iri (PCS11T)

The preclinical work on NGC-Iri (PCS11T) shows a commitment to optimizing dosing, which aligns with the FDA's Project Optimus initiative. This compound is a tumor-targeted pro-drug of SN-38, the active metabolite of irinotecan. Preclinical studies supported the potential for improved efficacy and a better side effect profile compared to irinotecan and Onivyde®. Specifically, the data showed that NGC-Iri delivered more cancer-killing SN-38 molecules to the tumor than either irinotecan or Onivyde®. Furthermore, less SN-38 accumulated in non-cancer tissues, such as muscle, after NGC-Iri administration compared to irinotecan or Onivyde® administration. This preclinical data was highlighted in abstracts accepted for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which took place from May 30 to June 3, 2025.

• PCS11T is designed to increase drug concentration in tumors.
• The goal is to reduce systemic toxicity.
• The preclinical work was featured at ASCO 2025.

Finance: draft 13-week cash view by Friday.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Key Resources

You're looking at the core assets Processa Pharmaceuticals, Inc. (PCSA) is leaning on right now to push its pipeline forward. These aren't just line items; they are the foundation of their near-term value proposition.

The most critical tangible assets are the intellectual property rights covering their three main clinical-stage drug candidates. These are the crown jewels, representing years of R&D investment and future revenue potential. It is defintely crucial to track the progress of each one.

Here's a breakdown of those key intellectual property holdings:

• Intellectual property for clinical-stage asset PCS6422.
• Intellectual property for clinical-stage asset PCS499.
• Intellectual property for clinical-stage asset PCS11T.

When we look at liquidity, the balance sheet as of the end of the third quarter of 2025 shows the immediate operational runway. Cash and cash equivalents stood at $6.3 million on September 30, 2025. This figure needs constant monitoring against burn rate, so you always want to see that number paired with recent financing activity.

Speaking of financing, Processa Pharmaceuticals, Inc. (PCSA) maintained access to capital markets through the first nine months of 2025, successfully raising $10.6 million in net proceeds. That capital infusion is a key resource supporting ongoing trials and operations.

We can summarize the recent financial resource movements here:

Beyond the balance sheet, the human capital is a non-negotiable resource in biotech. Processa Pharmaceuticals, Inc. (PCSA) relies heavily on its specialized R&D team and deep regulatory science expertise. These individuals translate the IP into clinical milestones, which is where the real value inflection happens.

Also note the value assigned to their digital assets, which were valued at $850,000 as of November 3, 2025. This reflects the importance of data infrastructure and proprietary systems in modern drug development.

Finance: draft 13-week cash view by Friday.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a patient or payer would choose Processa Pharmaceuticals, Inc. (PCSA) over the current standard of care. It's all about making existing, proven cancer drugs better, and tackling rare diseases where options are nonexistent.

Next Generation Cancer (NGC) drugs with improved safety and efficacy over existing chemotherapies.

Processa Pharmaceuticals, Inc. (PCSA) focuses on modifying the metabolism or distribution of established, FDA-approved oncology drugs. The goal here is to maintain the cancer-killing mechanism while delivering a better benefit-risk profile. This strategy is designed to facilitate quicker commercial adoption because the active molecules are already familiar to healthcare professionals.

The company is applying its Regulatory Science Approach, which incorporates principles from the FDA's Project Optimus Oncology initiative, to these NGC drug products.

PCS6422 (NGC-Cap) offering improved tolerability for metastatic breast cancer patients.

The lead asset, PCS6422 combined with capecitabine (NGC-Cap), is in an adaptive Phase 2 trial for advanced or metastatic breast cancer. This trial is specifically looking at patients who aren't candidates for anthracycline- or taxane-containing therapies, or other available options like PD-1 or PARP inhibitors. The value proposition here is built on earlier data showing a better tolerability profile.

Here are some specifics from the earlier clinical work that support this value proposition:

• Phase 1b data demonstrated improved safety compared to standard capecitabine monotherapy.
• Earlier data showed partial responses or stable disease in 66.7% (8 out of 12) evaluable patients.
• Progression-free survival in those patients was approximately 5 to 11 months.

The Phase 2 adaptive design trial is set up to assess the efficacy and safety of NGC-Cap against the standard dose of capecitabine alone.

PCS499 addressing a high unmet need in rare kidney diseases (PGDs) with a potential fast-track path.

For rare kidney diseases, specifically Focal Segmental Glomerulosclerosis (FSGS), the unmet need is urgent; there are currently no FDA-approved therapies specifically indicated for FSGS. PCS499 is positioned to address this gap. It's an analog of a metabolite of pentoxifylline (PTX).

You see the advantage when you compare it to the older agent:

Processa Pharmaceuticals, Inc. (PCSA) is designing an adaptive Phase 2/3 study for PCS499 to discuss with the FDA, aiming to optimize dosing and accelerate the path toward regulatory approval, which is a key part of the value proposition for an underserved population.

Reduced systemic toxicity via tumor-targeted pro-drug design (PCS11T).

PCS11T is Processa Pharmaceuticals, Inc. (PCSA)'s preclinical oncology asset, which is a tumor-targeted pro-drug of SN-38, the active metabolite of irinotecan. The design explicitly aims to increase the drug concentration within the tumor while simultaneously reducing systemic toxicity, which is a major issue with standard chemotherapy.

Preclinical data suggests a superior delivery mechanism:

• PCS11T (NGC-Iri) delivers more cancer-killing SN-38 molecules to tumor than either irinotecan or Onivyde®.

This targeted approach is a clear value driver, promising better local effect with less off-target exposure. Finance: draft 13-week cash view by Friday.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Customer Relationships

Processa Pharmaceuticals, Inc. manages relationships with key external stakeholders through highly structured, data-driven interactions, reflecting the company's reliance on scientific validation and regulatory navigation.

Strategic, long-term collaboration with licensing partners like Intact Therapeutics is a core relationship component, exemplified by the PCS12852 out-licensing deal announced in June 2025. This partnership is structured to provide Processa Pharmaceuticals, Inc. with non-dilutive funding and continued upside exposure.

High-touch engagement with clinical investigators and key opinion leaders underpins the development of the Next Generation Cancer (NGC) pipeline. The company leverages its Oncology Advisory Board, formed in November 2023, which includes Key Opinion Leaders (KOLs) from institutions such as the Mayo Clinic and Rutgers Cancer Institute. The KOL feedback for PCS11T suggests that removing even part of a black box warning would be a game-changer for prescribing physicians.

The Phase 2 study of PCS6422 (NGC-Cap) in metastatic breast cancer is actively enrolling patients, with preliminary analysis data anticipated in the second half of 2025. The company's development team has direct experience supporting this engagement, having been involved with more than 30 drug approvals by the FDA and over 100 FDA meetings throughout their careers.

Direct management of regulatory relationships with the FDA is managed through the company's Regulatory Science Approach. This approach was successfully used to negotiate the Phase 2 study protocol for PCS6422 with the FDA. Dr. David Young, President of Research & Development, has personally met with the FDA over one hundred times and was a key member on more than thirty FDA indication approvals.

Active investor relations via webinars and conference participation is a consistent activity to manage shareholder relationships and seek strategic partnerships. Processa Pharmaceuticals, Inc. management participated in the 2025 BIO CEO & Investor Conference on February 10-11, 2025, and the 2025 BIO International Convention from June 16-19, 2025. An investor webinar with RedChip was held on July 9, 2025. Insider activity in the six months leading up to May 2025 showed 4 purchases and 0 sales of PCSA stock.

• KOLs on Oncology Advisory Board: Members from Henry Ford Cancer Institute, Mayo Clinic, Rutgers Cancer Institute, and TGen Research Institute.
• PCS6422 Phase 2 Trial Enrollment: Remaining patients needed for interim analysis expected to be enrolled in the second half of 2025.
• Investor Meetings Scheduled via BIO Partnering portal for the 2025 BIO International Convention.
• Development Team FDA Experience: Involved in over 30 drug approvals.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Channels

You're looking at how Processa Pharmaceuticals, Inc. (PCSA) gets its drug development and financing efforts out to the world. For a clinical-stage company, the channels are less about direct sales and more about clinical execution, data dissemination, and capital acquisition.

Clinical trial sites and oncology centers for drug development and patient access

The primary channel for advancing the core oncology pipeline involves active clinical sites. Processa Pharmaceuticals, Inc. is actively enrolling patients in its Phase 2 study for its lead asset, NGC-Cap (PCS6422) combined with capecitabine, targeting advanced or metastatic breast cancer.

The company anticipated that the remaining patients required for the pre-planned interim analysis of the Phase 2 trial would be enrolled during the second half of 2025. Furthermore, for its PCS499 program in primary glomerular diseases (PGDs), Processa Pharmaceuticals, Inc. is establishing the design for a new adaptive pivotal Phase III study, with plans to discuss this design with the FDA in the fourth quarter of 2025.

• Lead oncology asset, NGC-Cap, in Phase 2 trial for metastatic breast cancer.
• PCS499 Phase III study design planned for discussion in Q4 2025.

Scientific and medical conferences (e.g., ASCO 2025) to disseminate clinical data

Dissemination of clinical and preclinical data is a critical channel for establishing scientific credibility and attracting potential partners. Processa Pharmaceuticals, Inc. successfully presented data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which took place from May 30 to June 3, 2025.

The company secured acceptance for three abstracts at ASCO 2025, showcasing advancements for drug candidates including PCS6422 and PCS11T. One presentation was a Trials in Progress Poster Presentation, Abstract Number TPS1133, at Poster Board Number 105b on June 2, 2025. The published abstracts carried numbers such as e15152 and e15023.

Processa Pharmaceuticals, Inc. also participated in the 2025 BIO International Convention from June 16-19, 2025, and had a presence at the American Society of Nephrology (ASN) Kidney Week 2025 on November 7, 2025.

Out-licensing agreements to commercialize non-core assets (PCS12852)

Monetizing non-oncology assets is a key channel for non-dilutive funding and value realization. Processa Pharmaceuticals, Inc. entered into a binding term sheet with Intact Therapeutics for the exclusive option to license PCS12852, a 5-HT4 receptor agonist for gastroparesis.

The financial structure of this channel is substantial, with Processa Pharmaceuticals, Inc. eligible for a $2.5 million option exercise fee. Total potential milestone payments are valued at over $432.5 million, which includes up to $20 million in development and regulatory milestones and over $432.5 million in commercial milestones. Processa Pharmaceuticals, Inc. will also receive double-digit royalties on worldwide net sales, excluding South Korea, and a 3.5% equity stake in Intact Therapeutics.

A crucial term of this channel is that Processa Pharmaceuticals, Inc. must share 60% of any cash payments received with its licensor.

Capital markets (NASDAQ) for raising equity financing

The NASDAQ listing serves as the primary channel for raising necessary equity financing to fund ongoing clinical development. Processa Pharmaceuticals, Inc. executed multiple public offerings in 2025 to bolster its balance sheet.

For the nine months ended September 30, 2025, the company reported raising $10.6 million through public offerings. This includes a completed offering in January 2025 that raised $5 million in gross proceeds, with shares priced at $0.615 for institutional investors and $0.7975 for the CEO and board members. Later, in June 2025, the company announced pricing of a $7 million public offering, involving the sale of 28,000,000 shares at $0.25 per share, alongside warrants.

The July 2025 portfolio update specifically cited a $7M capital infusion as having strengthened the balance sheet.

• $10.6 million raised through public offerings (nine months ended Sep 30, 2025).
• $7 million gross proceeds from June 2025 offering at $0.25 per share.
• $5 million gross proceeds from January 2025 offering.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Customer Segments

Processa Pharmaceuticals, Inc. (PCSA) targets distinct groups whose needs drive the development and financing of its pipeline assets, PCS6422 and PCS499.

Oncology patients with advanced or metastatic breast cancer (PCS6422 target).

• Estimated 170,000 women in the U.S. living with metastatic breast cancer in 2025.
• PCS6422, in combination with capecitabine (NGC-Cap), is in a Phase 2 study for metastatic breast cancer.
• Initial data from the NGC-Cap Phase 2 clinical trial is anticipated in the second half of 2025.
• The broader oncology market exceeds $180 billion.

Patients with rare kidney diseases, specifically Primary Glomerular Diseases (PCS499 target).

• PCS499 is being developed for Focal Segmental Glomerulosclerosis (FSGS), a serious condition with limited treatment options.
• The FDA accepts a surrogate endpoint of albuminuria/proteinuria for Primary Glomerular Diseases (PGDs).
• Processa is designing an adaptive Phase III study for PCS499 in FSGS to discuss with the FDA later in 2025.
• The standardized incidence of primary FSGS was estimated at 1.7 cases per 100,000 patient-years (based on 2010-2021 data).
• The United States has the largest patient pool for FSGS among the top seven major markets analyzed.

Large pharmaceutical and biotech companies for future licensing and M&A.

These entities seek innovative therapies to integrate or acquire, creating strategic monetization opportunities for Processa Pharmaceuticals, Inc. (PCSA).

• Processa is creating value through strategic business development.
• A binding term sheet was signed granting Intact Therapeutics an exclusive option to license PCS12852.
• This licensing deal is structured for Processa to be eligible for up to $454 million in milestone payments.
• The potential return includes a 12% royalty on future sales and a 3.5% equity stake in Intact.

Equity investors providing capital for R&D operations.

This segment provides the necessary capital to advance clinical trials, as reflected in the company's recent financial performance and funding activities.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Cost Structure

You're looking at where Processa Pharmaceuticals, Inc. (PCSA) is spending its capital to push the pipeline forward, which is typical for a clinical-stage biopharma company. The costs are heavily weighted toward development activities, as you'd expect since they report no revenue under contract or immediate sales prospects as of late 2025.

The primary cost drivers are clearly Research and Development (R&D) and General and Administrative (G&A) overhead. For the third quarter of 2025, the R&D spend was reported at $1.66 million, which was actually a decrease from the prior year, largely due to lower costs associated with the NGC-Cap clinical trials for that specific quarter. Right alongside that, General and Administrative expenses totaled $1.82 million for Q3 2025, marking a significant increase of approximately $681,000 compared to Q3 2024.

Here's a quick look at those headline quarterly figures:

Digging into the components, you see how those R&D dollars break down. For instance, looking at the first quarter of 2025, the specific outlay for preclinical, clinical trial, and other related costs was $1,197,035. That number reflects the ongoing nature of the Phase 1B and Phase 2 clinical trials for NGC-Cap.

Salaries, stock-based compensation, and professional fees make up the bulk of the operating expenses outside of direct clinical spend. For R&D specifically, salaries and benefits for the three months ended March 31, 2025, were $391,505. To be fair, G&A costs in the prior year showed a reduction due to lower professional fees and stock-based compensation, suggesting management is watching those discretionary overhead items closely, though G&A rose substantially in Q3 2025.

The costs associated with maintaining intellectual property, like patent filings and legal defense of those assets, are an inherent, though often less granularly reported, part of the R&D and G&A structure for a company like Processa Pharmaceuticals, Inc. These costs are necessary to protect the proprietary Regulatory Science Approach and the pipeline candidates like PCS6422.

The cost structure is further defined by these key operational elements:

• Clinical trial execution and regulatory filing costs for NGC-Cap.
• R&D salaries and benefits, which saw a decrease in Q1 2025 due to voluntary departures.
• General and administrative expenses, which surged in Q3 2025.
• Costs related to ongoing clinical trials for Phase 2 programs.

Finance: draft 13-week cash view by Friday.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Revenue Streams

You're looking at Processa Pharmaceuticals, Inc.'s (PCSA) revenue streams as of late 2025. Honestly, for a clinical-stage company, the revenue picture is all about financing and future potential, not product sales yet. This is typical for the stage they are in.

The most immediate, concrete funding source has been capital markets activity. Throughout the first nine months of 2025, Processa Pharmaceuticals successfully raised net proceeds of $10.6 million through public offerings, selling over 15 million shares of common stock. These funds are earmarked to support ongoing research and development initiatives for NGC-Cap and general corporate purposes.

As for product sales, the reality is that as of Q3 2025, Processa Pharmaceuticals recorded zero revenue under contract or immediate sales prospects. The company is still firmly in the clinical development phase, not commercialization.

The major upside potential comes from non-core asset monetization, specifically the binding term sheet signed with Intact Therapeutics for PCS12852. This deal is structured to bring in significant non-dilutive cash flow if development milestones are hit.

Here's a quick breakdown of the potential deal value:

• Potential milestone payments total up to $454 million.
• Future royalties are set at 12% on net sales of the licensed asset.
• Processa also retains a 3.5% equity stake in Intact Therapeutics.

The structure of the PCS12852 deal is quite detailed, showing how the potential $454 million is segmented. Remember, Processa must share 60% of cash payments with its licensor, excluding the equity stake.

Furthermore, Processa Pharmaceuticals is exploring innovative financial strategies. On August 7, 2025, the company announced its exploration of corporate cryptocurrency treasury strategies to diversify its capital base. As of November 3, 2025, the company held $850,000 in digital assets, with plans to further capitalize on this emerging asset class.

The potential income streams can be summarized by their nature:

• Immediate, non-dilutive cash from financing activities.
• Contingent, large-scale payments from licensing milestones.
• Long-term, passive income from future royalties.
• Strategic, liquid asset holdings from treasury diversification.

Finance: draft 13-week cash view by Friday.