Processa Pharmaceuticals, Inc.
For the period ended Jun 30, 2026. Filed Aug 14, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 14, 2026
PCSA$1.93+4.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001493152-26-021721
Item 2. : Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-14.
0001493152-26-038334
Item 2. : Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 55 previous paragraphs and 60 current paragraphs.
32 unchanged; 14 reworded; 13 added; 8 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 3 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (13)
Current report
We are a clinical-stage biotechnology company. In July 2026, we acquired Vidya Therapeutics, Inc. (“Vidya”), a clinical-stage biotechnology company developing VT-7208, a Bruton’s tyrosine kinase (“BTK”) inhibitor therapy for immune-mediated diseases with an initial focus on food allergy, chronic spontaneous urticaria (“CSU”) and relapsing multiple sclerosis (“RMS”). We are also continuing the development of our legacy pharmaceutical assets, including PCS499, PCS12852 and PCS11T, while evaluating strategic opportunities designed to maximize their clinical and long-term value.
Current report
Vidya Acquisition
Current report
On July 28, 2026, we acquired Vidya, which brought Vidya’s lead asset VT-7208 into our pipeline. In connection with our acquisition of Vidya, we received $200 million in gross proceeds from a private placement financing of shares of our non-voting convertible preferred stock. We intend to use the net proceeds of $183.3 million from the private placement to fund operations into the second half of 2029 and through key clinical milestones, including top-line data from Phase 2 proof-of-concept studies for food allergy, CSU and RMS.
Current report
Elion Settlement Agreement
Current report
On July 23, 2026, we entered into a settlement agreement with Elion Oncology, Inc. (“Elion”) to resolve all claims arising from the parties’ litigation concerning the license agreement dated August 23, 2020, relating to the commercialization of PCS6422 (the “Elion License Agreement”). Under the settlement agreement, the Elion License Agreement was terminated, the PCS6422 program was returned to Elion, and the parties exchanged mutual releases of all claims relating to the Elion License Agreement, the PCS6422 program, and the related litigation.
Current report
In connection with the settlement, we paid Elion $650,000 toward its attorneys’ fees and other out-of-pocket costs. We also agreed to grant Elion a non-voting equity interest equal to 7.5% of the fully diluted pre-money equity capitalization of any newly formed entity whose assets include one or more of PCS499, PCS12852, or PCS11T, provided that the formation or spin-out of such entity is completed within 365 days after the effective date of the settlement agreement.
Current report
As a result of the settlement and the return of the PCS6422 program to Elion, we are closing our ongoing Phase 2 clinical trial of PCS6422 in advanced or metastatic breast cancer. On August 7, 2026, the stipulation of dismissal became effective, resulting in the dismissal of the litigation with prejudice.
Current report
Other 2026 Fundraising
Current report
In addition to advancing the clinical-stage BTK inhibitor program in multiple indications, we continue to evaluate the development of our other legacy pharmaceutical assets PCS499, PCS12852, and PCS11T, including strategic opportunities designed to maximize the clinical and long-term value of all assets.
Current report
The decrease in research and development expenses was primarily due to a decrease in preclinical, clinical trial, and other costs related to our NGC-Cap Phase 2 trial during the three and six months ended June 30, 2026 when compared to the same period in 2025. During the six months ended June 30, 2026, we placed the study on hold while performing our interim analysis.
Current report
Other Income/Expense
Current report
Other income/expense for the three and six months ended June 30, 2026 and 2025 were as follows:
Current report
Following our acquisition of Vidya and closing of the related $200 million gross private placement (from which we received net proceeds of $183.3 million) on July 30, 2026, we believe our cash and cash equivalents will be sufficient to satisfy our cash requirements over the next 12 months and beyond. This represents a material change from what we reported in our 2025 Form 10-K that disclosed substantial doubt of our ability to continue as a going concern.
Removed paragraphs (8)
Previous report
We are a publicly listed clinical-stage biopharmaceutical company. We are developing a pipeline of Next Generation Cancer therapy (“NGC”) small molecules, one of which is currently in a Phase 2 trial, while the other is in pre-clinical development. Our risk-mitigated strategy is to identify existing cancer therapies where the mechanism of action is well understood and that are cornerstones of current treatment regimens, but are highly toxic, with side effects that are often treatment limiting. We devise technologies to change the way the body metabolizes them, or the way they are distributed within the body, to improve the therapeutic effect and reduce toxicity. We then efficiently develop our pipeline of Next Generation Cancer therapies utilizing our proprietary Regulatory Science Approach, which we believe will further increase the likelihood of regulatory approval. Since the underlying active metabolites of these drugs are already commonly used in cancer therapy, we believe that if our clinical trials are successful and are showing a better safety-efficacy profile than the currently used drugs, the commercial adoption for our NGC therapies will be rapid and broad.
Previous report
Our oncology pipeline currently consists of NGC-Cap and NGC-Iri (also identified as PCS6422 and PCS11T, respectively) and two non-oncology drugs (PCS12852 and PCS499). We are exploring options for our non-oncology drugs, which may include out-licensing or partnership opportunities. The current status of our drug pipeline is set forth below:
Previous report
In 2025, we continued our Phase 2 trial of NGC-Cap in advanced or metastatic breast cancer patients. We have enrolled and dosed the 20 patients required for the planned first interim analysis, which is expected to be completed in the first half of 2026.
Previous report
Fundraising
Previous report
The increase in research and development expenses was primarily due to an increase in professional fees as we utilized more consultants for our Phase 2 clinical trial for NGC-Cap during the three months ended March 31, 2026 when compared to the same period in 2025. The increase was offset by decreases in employee stock-based compensation because of fewer outstanding equity grants, and in testing and related expenses as the R&D team are performing their interim analysis for the NGC-Cap Phase 2 trial.
Previous report
Other Income
Previous report
Other income represents interest income of approximately $14,000 and an unrealized loss on our digital assets of $60,000 for the three months ended March 31, 2026; and interest income of approximately $13,000 for the three months ended March 31, 2025.
Previous report
At March 31, 2026, we had cash and cash equivalents totaling $1.7 million. Together with the $219,000 we raised in April 2026, we believe we will need to raise additional capital in the second quarter of 2026 based on our current business plans. However, absent additional funding, our current cash and cash equivalents will not be sufficient to fund our planned operations for a period of one year or more after the date that these condensed consolidated financial statements were available to be issued based on the timing and amount of our projected net loss from continuing operations and the related amount of cash to be used in operating activities during that period of time. Our ability to execute our longer-term operating plans, including future preclinical studies and clinical trials for our portfolio of drugs depend on our ability to obtain additional funding from the sale of equity and/or debt securities, a strategic transaction or other funding transactions.
Reworded paragraphs (14)
Previous wording
On February 17, 2026 where we sold 86,956 shares of our common stock to an accredited investor in a private placement transaction for $200,000. On March 31, 2026, certain directors, officers, and employees purchased 17,796 shares of common stock for approximately $45,000. They also purchased 22,008 shares of common stock for approximately $62,000 during the month ended April 30, 2026. In April 2026, we also sold 50,330 shares of common stock under our ATM Offering for approximately $157,000 in net proceeds. We plan to use the net proceeds from these raises for continued research and development for NGC-Cap, and for working capital and general corporate purposes.
Current wording
On February 17, 2026 where we sold 86,956 shares of our common stock to an accredited investor in a private placement transaction for $200,000. During the six months ended June 30, 2026, certain directors, officers, and employees purchased 82,205 shares of common stock for approximately $207,000. In April 2026, we also sold 50,330 shares of common stock under our ATM Offering for approximately $153,000 in net proceeds. Concurrent with the acquisition of Vidya, we entered into a definitive agreement for a private placement financing to raise approximately $200 million in gross proceeds, which we expect to use to support the advancement of VT-7208 through multiple clinical milestones, including data from a Phase 2 proof-of-concept study in food allergy anticipated in the second half of 2027, data from a Phase 2 proof-of-concept study in CSU anticipated in the first half of 2028, and data from a Phase 2 proof-of-concept study in RMS anticipated in the second half of 2028.
Previous wording
Comparison of the three months ended March 31, 2026 and 2025
Current wording
Comparison of the three and six months ended June 30, 2026 and 2025
Previous wording
During the three months ended March 31, 2026, our research and development expenses increased by approximately $221,000 to $1.8 million from $1.6 million for the three months ended March 31, 2025. Costs for the three months ended March 31, 2026 and 2025 were as follows:
Current wording
Costs for the three and six months ended June 30, 2026 and 2025 were as follows:
Previous wording
Our general and administrative expenses for the three months ended March 31, 2026 increased by approximately $264,000 to $1.5 million from $1.3 million for the three months ended March 31, 2025. This increase was due primarily to increases in professional fees of approximately $226,000; insurance expense of approximately $85,000; salaries and payroll-related expenses of $60,000; and travel-related expenses of approximately $33,000. The increases were offset by decreases in franchise tax expense of $35,000; office and other miscellaneous expenses of $26,000; rent expense of $22,000; and employee stock-based expenses of $70,000. We received approximately $13,000 less in reimbursements from CorLyst during the three months ended March 31, 2026 when compared to the same period in 2025.
Current wording
Our general and administrative expenses for the three months ended June 30, 2026 increased by approximately $183,000 to $1.7 million from $1.5 million for the three months ended June 30, 2025. This increase was due primarily to increases in professional fees of approximately $179,000; insurance expense of approximately $58,000; franchise tax expense of approximately $50,000; salaries and payroll-related expenses of $34,000; and other miscellaneous office expenses of $4,000. The increases were offset by decreases in employee stock-based expenses of $74,000; rent expense of $22,000; office and other miscellaneous expenses of $20,000; repairs and maintenance expense of $12,000; and travel expenses of $11,000. We received approximately $3,000 more in reimbursements from CorLyst during the three months ended June 30, 2026 when compared to the same period in 2025.
Previous wording
We did not recognize any income tax benefit for the three months ended March 31, 2026 or 2025.
Current wording
We did not recognize any income tax benefit for the three and six months ended June 30, 2026 or 2025.
Previous wording
The following table sets forth our sources and uses of cash and cash equivalents for the three months ended March 31, 2026 and 2025:
Current wording
The following table sets forth our sources and uses of cash and cash equivalents for the six months ended June 30, 2026 and 2025:
Previous wording
We used net cash in our operating activities of $3.6 million and $2.7 million during the three months ended March 31, 2026 and 2025, respectively. The increase in cash used in operating activities during the first quarter of 2026 compared to the same period in 2025 of approximately $861,000 was primarily related to the increased professional/consulting fees, insurance, and travel related expenses incurred, as well as a paydown in our accounts payable.
Current wording
We used net cash in our operating activities of $5.6 million and $5.0 million during the six months ended June 30, 2026 and 2025, respectively. The increase in cash used in operating activities during the first half of 2026 compared to the same period in 2025 was primarily related to the increased professional/consulting fees, insurance, payroll, and travel related expenses incurred.
Previous wording
As we continue our development of NGC-Cap and evaluate the other NGC drugs in our portfolio, we anticipate our research and development efforts and ongoing general and administrative costs will continue to generate negative cash flows from operating activities for the foreseeable future. As we continue our Phase 2 clinical trial for NGC-Cap in 2026, we anticipate our clinical trial costs will increase when compared to prior periods since activities in 2025 were primarily related to the completion of our Phase 1B trial and setup of our Phase 2 trial for NGC-Cap.
Current wording
As we advance VT-7208 through three Phase 2 proof-of-concept studies, and evaluate the legacy product candidates in our portfolio, we anticipate our research and development efforts and ongoing general and administrative costs will continue to generate negative cash flows from operating activities for the foreseeable future. We anticipate our clinical trial costs will increase in the second half of 2026 when compared to prior periods as we initiate Phase 2 studies of VT-7208 in food allergy and chronic spontaneous urticaria, since activities in 2025 were primarily related to the completion of our Phase 1B trial and setup of our NGC-Cap Phase 2 trial.
Previous wording
We used $500,000 in investing activities to purchase additional digital assets during the three months ended March 31, 2026. We did not use any cash in investing activities during the same period in 2025.
Current wording
We used $500,000 in investing activities to purchase digital assets and received $186,000 for the sale of digital assets during the six months ended June 30, 2026. We did not use any cash in investing activities during the same period in 2025.
Previous wording
During the three months ended March 31, 2026, we sold 104,752 shares of our common stock to an accredited investor, and certain directors, officers, and employees for cumulative net proceeds of $245,000. We also used cash classified as financing activities of $320 to pay income taxes owed on stock-based compensation.
Current wording
During the six months ended June 30, 2026, we sold 219,491 shares of our common stock to an accredited investor, and certain directors, officers, and employees for cumulative net proceeds of $560,270. We used cash classified as financing activities of $320 to pay income taxes owed on stock-based compensation.
Previous wording
During the three months ended March 31, 2025, we sold 41,239 shares of our common stock, pre-funded warrants to purchase up to 280,788 shares of our common stock, and accompanying Series A Warrants to purchase up to 322,027 shares of our common stock and Series B Warrants to purchase up to 161,014 shares of our common stock for net proceeds of $4.4 million. We also used cash classified as financing activities of $1,439 to pay income taxes owed on stock-based compensation, and $1,536 for payments owed under a financing lease obligation.
Current wording
During the six months ended June 30, 2025, we sold 613,639 shares of our common stock, pre-funded warrants to purchase up to 828,388 shares of our common stock, accompanying Series A Warrants to purchase up to 322,027 shares of our common stock and Series B Warrants to purchase up to 161,014 shares of our common stock, and common accompanying warrants to purchase up to 1,120,000 shares of common stock for net proceeds of $10.7 million. We also received $100,000 from the exercise of warrants to purchase 16,000 shares of common stock. We also used cash classified as financing activities of $10,000 to pay income taxes owed on stock-based compensation, and $3,000 for payments owed under a financing lease obligation.
Previous wording
We have incurred losses since inception, currently devoting substantially all our efforts toward research and development of our next generation chemotherapy drug product candidates, including conducting clinical trials and providing general and administrative support for these operations, and have an accumulated deficit of $104.2 million at March 31, 2026. During the three months ended March 31, 2026, we generated a net loss of $3.4 million and used $3.6 million in net cash for operating activities from continuing operations. To date, none of our drug candidates have been approved for sale, and therefore we have not generated any product revenue and do not expect positive cash flow from operations in the foreseeable future. We will continue to be dependent upon equity and/or debt financing until we are able to generate positive cash flows from its operations.
Current wording
We have incurred losses since inception, currently devoting substantially all our efforts toward research and development of our product candidates, including conducting clinical trials and providing general and administrative support for these operations, and have an accumulated deficit of $107.4 million at June 30, 2026. During the six months ended June 30, 2026, we generated a net loss of $6.6 million. To date, none of our drug candidates have been approved for sale, and therefore we have not generated any product revenue and do not expect positive cash flow from operations in the foreseeable future. We will continue to be dependent upon equity and/or debt financing until we are able to generate positive cash flows from its operations.
Previous wording
There have been no significant changes to the contractual obligations reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
Current wording
During the six months ended June 30, 2026, there have been no significant changes to the contractual obligations reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
Previous wording
There have been no changes in our critical accounting policies from those included in our most recent Annual Report on Form 10-K.
Current wording
During the six months ended June 30, 2026, there have been no changes in our critical accounting policies from those included in our most recent Annual Report on Form 10-K.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Our general and administrative expenses for the six months ended June 30, 2026 increased by approximately $446,000 to $3.2 million from $2.8 million for the six months ended June 30, 2025. This increase was due primarily to increases in professional fees of approximately $405,000; insurance expense of approximately $144,000; salaries and payroll-related expenses of $94,000; travel expenses of $22,000; and franchise tax expense of approximately $15,000. The increases were offset by decreases in employee stock-based expenses of $144,000; rent expense of $46,000; office and other miscellaneous expenses of $42,000; and repairs and maintenance expense of $12,000. We received approximately $10,000 less in reimbursements from CorLyst during the six months ended June 30, 2026 when compared to the same period in 2025.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
On February 17, 2026 where we sold 86,956 shares of our common stock to an accredited investor in a private placement transaction for $200,000. On March 31, 2026, certain directors, officers, and employees purchased 17,796 shares of common stock for approximately $45,000. They also purchased 22,008 shares of common stock for approximately $62,000 during the month ended April 30, 2026. In April 2026, we also sold 50,330 shares of common stock under our ATM Offering for approximately $157,000 in net proceeds. We will continue to be dependent upon equity and/or debt financing until we are able to generate positive cash flows from its operations.