UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number 001-39531 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 45-1539785 (State ...

Processa Pharmaceuticals Clinical Pipeline Update March 30, 2022 Disclaimer: Forward Looking Statements The following summary is provided for informational purposes only and does not constitute an offer or solicitation to acquire interests in the investment or any related or associated company. The information contained here is general in nature and is not intended as legal, tax or investment advice. Furthermore, the information contained herein may not be applicable to or suitable for an individual's speci ...

Financial Data and Key Metrics Changes - As of December 31, 2021, the company had a cash balance of $16.5 million, an increase of $1.1 million compared to December 31, 2020 [8][9] - The net loss for the year ending December 31, 2021, was $11.4 million or $0.75 per share, a reduction from a net loss of $14.4 million or $2.54 per share for the same period in 2020 [13] - Research and development expenses totaled $6.9 million for 2021, compared to $3.2 million for the same period in 2020, indicating a significant increase in R&D costs [15][16] Business Line Data and Key Metrics Changes - The company licensed PCS3117 from Ocuphire for cash and stock totaling $567,000, contrasting with $8.7 million in costs incurred for other licensing activities [14] - General and administrative expenses increased to $4.7 million in 2021 from $3.3 million in 2020, primarily due to higher professional fees and non-cash stock-based compensation [16] Market Data and Key Metrics Changes - The company is focused on five drugs in its pipeline, each addressing a different unmet medical need with a potential market size exceeding $1 billion [21][22] - The market potential for PCS499, aimed at treating necrobiosis lipoidica, is estimated to be around $1 billion, despite the challenges in patient enrollment due to COVID-19 [36][40] Company Strategy and Development Direction - The company is developing five drugs simultaneously, all at different stages, with multiple near-term milestones expected from March to August 2022 [22][23] - The strategy includes a focus on regulatory science to navigate FDA requirements effectively, leveraging past experiences with FDA contracts [22] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by COVID-19 on patient enrollment but emphasized ongoing efforts to improve recruitment through advertising and physician referrals [50][66] - The company anticipates continued increases in clinical trial costs as it progresses with its drug development activities [15] Other Important Information - A purchase agreement with Lincoln Park Capital LP allows the company to sell up to $15 million worth of common stock over the next three years, serving as a financing insurance policy [12] - The company has modified the Phase 1b protocol for the next-generation capecitabine to better understand DPD inhibition and de novo formation timelines [34] Q&A Session Summary Question: Clarification on PCS499 prevalence estimates - Management noted that while literature suggests a prevalence of 22,000 to 55,000 patients, the actual interest in enrollment has been lower, prompting remedial actions to increase recruitment [49][50] Question: Pricing flexibility based on prevalence - Management indicated that the seriousness of the condition provides pricing flexibility, estimating a potential price range of $30,000 to $50,000 per year for patients [51][54] Question: Update on prescreening patients - Management confirmed that a couple of patients died from COVID before screening, affecting the number of patients in prescreening [55][56] Question: Data expectations for DPD inhibition - Management expects to gather data on DPD inhibition timelines by mid-2022, which will inform dosing regimens for the next-generation capecitabine [58] Question: Efficacy signal for 6422 - Management clarified that the 10% estimate for 5-FU metabolism is based on previous preclinical and clinical studies [63][64] Question: Enrollment criteria for PCS499 - Management stated that the exclusion of patients was not due to strict ulcer size criteria but rather other health conditions [65][66] Question: Therapeutic window for next-generation capecitabine - Management indicated that while monitoring for neurotoxicity and cardiotoxicity, they do not expect these to limit the maximum tolerated dose [78][80] Question: Establishing maximum tolerated dose - Management explained that the focus will be on determining the maximum tolerated dose of capecitabine, with adjustments based on DPD inhibition kinetics [82][85]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual Report under Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2021 or ☐ Transitional Report under Section 13 or 15(d) of the Securities Exchange Act of 1934 Commission File Number 001-39531 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 45-1539785 (IRS Employer ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number 001-39531 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 45-1539785 (S ...

Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) Q3 2021 Earnings Conference Call November 11, 2021 5:30 PM ET Company Participants Jim Stanker – Chief Financial Officer David Young – Chief Executive Officer Conference Call Participants Robin Garner – Craig-Hallum François Brisebois – Oppenheimer Aydin Huseynov – Benchmark Julian Harrison – BTIG Operator Greetings, and welcome to Processa Pharmaceuticals Third Quarter 2021 Earnings Conference Call and Corporate Update. At this time, all participants are in a li ...

2Q 2021 Earnings Call | August 12, 2021 | --- | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) Q2 2021 Earnings Conference Call August 12, 2021 5:30 PM ET Company Participants James Stanker - Chief Financial Officer David Young - Chief Executive Officer Conference Call Participants François Brisebois - Oppenheimer & Co. Inc. Aydin Huseynov - The Benchmark Company, LLC Robin Garner - Craig-Hallum Capital Group LLC Operator Greetings and welcome to Processa Pharmaceuticals Second Quarter 2021 Earnings Conference Call and Corporate Update. At this time, all p ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number 001-39531 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 45-1539785 (State ...

LD Micro Invitational June 9, 2021 David Young, PharmD, PhD Chairman and CEO | --- | --- | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ...