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Another Game-Changing Announcement Sends (PCSA) Vertical First Thing, Up Approximately 11%

December 14th

Greetings Readers,

PCSA is cooking with heat early this AM.

Currently up approximately 11%, PCSA dropped some huge breaking news today. Check it out:

Processa Pharmaceuticals Announces PCS12852 Successfully Improves the Clinical Symptoms Associated with Gastroparesis in Phase 2A Trial

• A 0.5 mg daily dose of PCS12852 administered over 28 days in gastroparesis patients successfully improved gastroparesis symptoms in a clinically meaningful way as defined by greater than a 0.5 reduction in the ANMS GCSI-DD score compared to baseline.
• The percentage of patients who met the clinically meaningful change in symptom score was greater in the PCS12852 0.5 mg daily dose group than in the placebo or the PCS12852 0.1 mg daily dose groups.
• Over 28 days the mean gastroparesis symptoms score continually improved more for the 0.5 mg PCS12852 group than the placebo group suggesting that longer treatment than 28 days may result in greater differences in gastroparesis symptoms for a 0.5 mg daily dose of PCS12852 than for placebo.
• The results, in addition to the previously announced improvements in gastric emptying in patients that received the daily dose of 0.5 mg of PCS12852, further support initiating a PCS12852 Phase 2B trial in 2023 for the treatment of gastroparesis.

HANOVER, MD, Dec. 14, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a diversified clinical-stage company developing products to improve survival and/or the quality of life for patients who have an unmet medical need condition, today announced positive top-line results on the clinical symptoms associated with gastroparesis from a 4-week Phase 2A study of PCS12852, which is being developed for the treatment of patients with gastroparesis. The trial was a placebo-controlled, randomized, dose-response study designed to evaluate the safety, efficacy, and pharmacokinetics of two dosage regimens of PCS12852 vs placebo (clinicaltrials.gov identifier NCT05270460). Processa previously announced an improvement in the primary endpoint of the study, the gastric emptying rate, in patients that received a 0.5 mg daily dose of PCS12852. The results from this Phase 2A study also showed that clinically meaningful improvements in gastroparesis symptoms occurred in more patients (i.e., a greater percentage of patients) receiving the PCS12852 0.5 mg daily dose than the placebo daily dose.

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Read the full article here.

On top of that, PCSA has also moved above its 50-Day Simple Moving Average on top of it already trading above the 4 other key lines I highlighted in the report below.

Drop everything and get PCSA on your radar now.

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Let's dive in. Shall we?

Monday's alert went to blast-off town and I mean early. Like pre-market early.

Brought to your attention on Sunday after closing at $2.86 Friday, your latest champ came out hot in pre-market on breaking news.

At times trading up approximately $1.00 from Friday's close, KWE carried that momentum into the opening bell to shoot to an intraday high of $3.57+.

That comes on the heels of last week's champ that knocked it out of the park from this past Thursday's close to Friday's high.

With an approximate 22%, we got this streak started in style.

Okay. Streak may be an overstatement. I'm thinking you need at least 3 in a row for that.

That's why I want you to check out this new Nasdaq breakout idea.

With it trading in after hours Tuesday above 4 key lines of potential support, having a low float of under 10Mn shares, and an analyst target providing over 300% potential upside at this moment, this Biotech profile requires immediate attention.

For Wednesday, December 14th, there is only one profile to fix your eyes on:

*Processa Pharmaceuticals, Inc. (PCSA)*

Processa Pharmaceuticals develops products that improve survival and quality of life for patients with unmet medical needs. Using their years of regulatory experience, they identify de-risked, underappreciated dr-ugs and develop assets with an unmet medical need and leverage prior research toward high value clinical milestones and a lower risk of development failure.

And right now we've identified multiple potential catalysts that could help lead PCSA to a near term breakout. Here they are:

No. 1 - Low Float Volatility Could Be On Display (Daily)

No. 2 - A $9.00 Analyst Target Provides Over 300% Potential Upside From Tuesday's Close

No. 3 - Positive Results Could Mean Big Things Ahead For This Little-Known Biotech

No. 4 - Profile Trading Above 4 Key Lines Of Potential Support

But more on those in second...

The Skinny - Key Processa Pharmaceuticals Company Details

The leadership team behind Processa Pharmaceuticals, Inc. (Nasdaq:PCSA) was brought together by a common goal: to help patients suffering from life-threatening and life-compromising chronic diseases.

The starting point for all the company’s programs begins with unmet medical needs for patients and caregivers. Processa allocates its resources to accelerate development of these life improving solutions.

Working together for over 30 years, the leadership team has garnered a unique approach to develop therapies today through learning and applying their R&D and regulatory expertise to efficiently position dr-ugs for approval success.

Throughout their careers, the combined scientific, development and regulatory experience of the Processa team members have resulted in more than 30 dr-ug approvals by the FDA, over 100 meetings with the FDA, and involvement with more than 50 dr-ug development programs, including dr-ug products targeted to patients who have an unmet medical need.

Next Generation Capecitabine (NGC) (a combination of PCS6422 and capecitabine): The company has identified lower capecitabine dosage regimens when administered in NGC that will help avoid dose-limiting toxicities such as hand-foot syndrome, yet provide approximately 50-times greater potency than capecitabine alone.

Next Generation Capecitabine (NGC): Improved Efficacy

PCS6422 Irreversibly Inhibits DPD (Dihydropyrimidine Dehydrogenase Enzyme)

• By combining a regimen of PCS6422 with a capecitabine regimen, the 5-FU formed from capecitabine is only metabolized to anabolites eliminating the adverse events from the catabolites while increasing the potency and potential anti-tumor and replicating cell side effects from the anabolites.
• After administration of PCS6422 until new DPD is formed in the patient, 5-FU is only cleared from the body by renal excretion and metabolism to the anabolites within the cells.
• Dosage regimens for NGC (both the PCS6422 and the capecitabine regimens) in a Phase 2B trial need to be evaluated to obtain the right balance between efficacy (anti-tumor response) and safety (for example, damage to replicating cells such as neutropenia, mucositis).

Moving Closer to NDA: Phase 1B Trial to Evaluate Safety

Each Next Generation Capecitabine (NGC) dosage regimen is a combination of a PCS6422 regimen and a separate capecitabine regimen. Example of a single treatment cycle:

• From the different NGC regimens evaluated, the timeline for the formation of new DPD is approximately 24-72 hours after the PCS6422 dose while NGC potency, based on 5-FU systemic exposure, was increased to 50-times greater than reported for FDA-approved capecitabine.
• Processa has successfully identified NGC dosage regimens and 5-Fluorouracil (5-FU) exposures that were well tolerated as well as NGC regimens and 5-FU exposures that had dose-limiting side effects.
• In 2023, Processa plans to initiate an efficacy/safety Phase 2B trial following FDA’s Project Optimus Initiative after meeting with the FDA.

Processa Pharmaceuticals, Inc. will complete this study in the near future and seek FDA confirmation of their plans to implement the principles of the Project Optimus Oncology Initiative, wherein the objective is to optimize dosing to achieve a better balance between efficacy and safety than merely using the maximum tolerated dose.

PCS12852: The company has shown a statistical difference in the gastric emptying rate between the 6 patients on 0.5 mg of PCS12852 and the 8 patients on placebo at p-value < 0.10 with mild to moderate adverse events. Processa anticipates having the analysis of the gastroparesis symptoms completed by the end of the year.

3Q2022 Highlights of Positive Next Generation Capecitabine (NGC) and PCS12852 Trials

• In the ongoing NGC Phase 1B trial, Processa has successfully identified NGC dosage regimens and 5-Fluorouracil (5-FU) exposures that were well tolerated as well as NGC regimens and 5-FU exposures that had dose-limiting side effects.
• From the different NGC regimens evaluated, the timeline for the formation of new DPD is approximately 24-72 hours after the PCS6422 dose while NGC potency, based on 5-FU systemic exposure, was increased to 50-times greater than reported for FDA-approved capecitabine.
• In 2023, Processa plans to initiate an efficacy/safety Phase 2B trial following FDA’s Project Optimus Initiative after meeting with the FDA.
• The PCS12852 Proof-of-Concept Phase 2A trial in gastroparesis patients has been completed with the results showing that the change in gastric emptying rate after 28 days of treatment on 0.5 mg of PCS12852 was statistically better than placebo treatment at a p-value less than 0.10.
• The change in gastroparesis symptoms for 12852 vs placebo is expected by the end of the year.
• Processa plans to initiate an efficacy/safety Phase 2B trial in 2023.

PCS12852: 5-HT4 Receptor Agonist - Wide Range of GI Motility Disorders

Clinically Proven Mechanism of Action

• Enhancement of both GI motility & secretion via increased Ach, 5-HT, Cl-and mucus release.
• Neural anti-inflammatory effects on post-operative ileus by inhibiting macrophage and neutrophil infiltration.
• Wide development potential to treat POGD, gastroparesis, CIC, IBS-c, OIC, and overlap syndrome.

PCS12852 Effect on Gastric Emptying: South Korean and US Trials

PCS12852 is a More Potent and More Selective 5HT4 Agonist than previous 5HT4 Agonists

South Korean Trial

7 – 8 patients per group

Healthy Volunteers (< 3 Bowel Movements per Wk) or Functional Constipation Patients

U.S. Phase 2A Proof-of-Concept Trial in Gastroparesis Patients

All of the company’s energies have been directed towards the completion of these trials that inform the next steps for these much-needed therapies.

Advancing these dr-ugs in their respective clinical trials allows Processa to obtain the clinical data to better define each pivotal trial as well as provide them with more insight into how the FDA will review each of these products as the company plans the road maps for designing the studies for its New Dr-ug Applications to FDA.

Read more from the company presentation here.

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And as I mentioned above, PCSA has several potential catalysts to know before Wednesday's opening bell. Check them out:

No. 1 PCSA Potential Catalyst - Low Float Volatility Could Be On Display (Daily)

According to the Yahoo Finance website, PCSA has a low float.

The website reports this profile to have approximately 9.98Mn shares in its float.

Why is that important? It's important on one crucial level. Volatility.

Could positive December company news help provide a near term spark?

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No. 2 PCSA Potential Catalyst - A $9.00 Analyst Target Provides Over 300% Potential Upside From Tuesday's Close

The Maxim Group has built one of the premier proprietary research platforms on Wall Street, with an emphasis on small-cap, micro-cap, and emerging growth companies.

The firm's research is both theme-based and trading-oriented with an ‘alpha-goal.’ Institutional clients, CEOs and board directors seek out their Senior Research Analysts for advice and expert opinions in their respective industry verticals.

Naz Rahman, a Vice President and Senior Research Analyst at Maxim Group covering the biotechnology sector has set a $9.00 target on Processa Pharmaceuticals, Inc. as of 12/2/22 according to a published report on the company’s website.

With this $9.00 target, there could be upside potential of over 300% for PCSA from its closing valuation Tuesday.

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No. 3 PCSA Potential Catalyst - Positive Results Could Mean Big Things Ahead For This Little-Known Biotech

PCS12852 Improves Gastric Emptying in Gastroparesis Patients

• In a Phase 2A Proof-of-Concept trial, the Gastric Emptying Breath Test (GEBT) results demonstrated statistical improvement in gastric emptying in gastroparesis patients receiving 0.5 mg of PCS12852 (6 patients) as compared to placebo (8 patients) at a p < 0.10 level.
• Adverse events associated with this Phase 2A trial were mild to moderate with no clinically significant cardiovascular or serious adverse events.
• Evaluation of the effect of PCS12852 on gastroparesis symptoms is expected before the end of this year.
• Processa plans to initiate a Phase 2B trial in 2023.

HANOVER, MD, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a diversified clinical-stage company developing products to improve survival and/or the quality of life for patients who have an unmet medical need condition, announces positive gastric emptying results from its PCS12852 Phase 2A trial in patients with moderate to severe gastroparesis. This Phase 2A trial was a 4-week placebo-controlled, randomized, dose-response trial designed to evaluate the effect of PCS12852 on gastric emptying, safety, pharmacokinetics, and gastroparesis symptoms. Two dosage regimens of PCS12852 versus placebo were evaluated in patients with moderate to severe gastroparesis.

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“We are pleased that this first Phase 2A study with PCS12852 was able to demonstrate a prokinetic effect and improve gastric emptying in gastroparesis patients,” said Dr. Sian Bigora, Chief Development Officer at Processa. “The data from this study will inform the design of our planned Phase 2B study. Gastroparesis continues to be a serious disease that has unmet needs, and we are hopeful that PCS12852 will ultimately help improve the quality of life of gastroparesis patients.”

Read the full article here.

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No. 4 PCSA Potential Catalyst - Profile Trading Above 4 Key Lines Of Potential Support

As of after hours Tuesday (approx. 4:30PM EST), PCSA was trading above 4 potential lines of support.

Could this potential support provide some firepower towards a possible vertical shot near term?

Here's the list:

• 5-Day Simple Moving Average
• 20-Day Simple Moving Average
• 5-Day Exponential Moving Average
• 13-Day Exponential Moving Average

If support continues to grow at those levels, it could turn in the building blocks for a continued vertical move that has seen PCSA grow as much as 40% from a $1.57 low last week to this week's $2.21 high.

Watch these lines closely this week.

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PCSA Recap - These Potential Catalysts Are Must-Know Material

No. 1 - Low Float Volatility Could Be On Display (Daily)

No. 2 - A $9.00 Analyst Target Provides Over 300% Potential Upside From Tuesday's Close

No. 3 - Positive Results Could Mean Big Things Ahead For This Little-Known Biotech

No. 4 - Profile Trading Above 4 Key Lines Of Potential Support

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Coverage is officially initiated on PCSA. When time permits, do this:

Get PCSA on your radar now.

Sincerely,

Kai Parker

StockWireNews

(Always Remember The Stock Prices Could Be Significantly Lower Now From The Dates I Provided.)