Processa Pharmaceuticals Announces Second Quarter 2021 Results and Provides Corporate Update
12 Agosto 2021 - 11:15PM
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical stage
biopharmaceutical company developing drugs to improve the survival
and/or quality of life for patients who have an unmet medical need
condition, announces today financial results for the quarter ended
June 30, 2021, and provides corporate update.
Dr. David Young, CEO and chairman of Processa,
commented, “During the second quarter we made significant progress
advancing our clinical programs, in-licensed another clinical asset
- RX-3117 – and will have four clinical programs with addressable
markets of $500 million to $1.5 billion. Looking at upcoming
milestones, we have begun to develop the biomarker assays for 3117
in pancreatic cancer patients with the expectation that the assay
validation will be completed in the first half of 2022. We also
anticipate filing an IND in September for PCS12852 with site
initiation beginning before year end. Additionally, we expect
interim data for PCS6422 in the fourth quarter of 2021 and interim
data for PCS499 during the first half of 2022. Taken altogether, we
see a consistent cadence of upcoming catalysts and tremendous
amount of near-term value creation.”
Recent Highlights and New Developments
- Dosed
our first two patients in the PCS499 Phase 2B ulcerative
Necrobiosis Lipoidica (NL) trial. NL is a rare, chronic,
idiopathic, granulomatous disease that can significantly effect a
patient’s quality of life and is caused by a number of diverse
pathophysiological changes in a patient. There are no approved
treatments for NL or ulcerative NL and no acceptable standard of
care. Approximately 30% of NL patients have the ulcerative form of
NL.
- Dosed
our first patient in our Phase 1B trial evaluating the safety and
PK of PCS6422 and capecitabine when administered to patients with
advanced, refractory GI cancer. The combination of PCS6422 and
capecitabine is expected to improve the benefit-risk profile of
capecitabine by improving capecitabine safety and/or efficacy.
- Licensed
in PCS3117 (formerly RX-3117), an oral, anticancer agent with an
improved pharmacological profile relative to gemcitabine. PCS3117
has a family of patents extending into 2036 as well as U.S. Food
and Drug Administration (FDA) Orphan Designation for the treatment
of Pancreatic Cancer. Processa has begun to develop biomarkers
assays to better predict which patients with pancreatic or
non-small cell lung cancer are more likely to benefit from PCS3117
over gemcitabine and other chemotherapeutic agents.
- Joined
the Russell Microcap ®, resulting in automatic inclusion in the
appropriate growth and value style indexes. FTSE Russell determines
membership for its Russell indexes primarily by objective,
market-capitalization rankings and style attributes.
Upcoming Clinical Drug Development
Milestones
Second half of 2021
- Complete
enrollment of 8-10 patients for the PCS499 Phase 2B interim
analysis
- Submit
PCS12852 IND application to FDA for Gastroparesis and initiate
sites
- Begin
assay development of biomarkers for PCS3117 in pancreatic
cancer
- Complete
interim analysis of PCS6422 Phase 1B trial in GI cancer
2022
- Interim
analysis of PCS499 Phase 2B trial in ulcerative NL
- Final
analysis of PCS499 Phase 2B trial in ulcerative NL
- Enroll
and complete PCS12852 Phase 2A gastroparesis trial
- Complete
assay validation of biomarkers for PCS3117 and initiate sites for
Phase 2B pancreatic cancer trial
-
Determine the maximum tolerated dose for capecitabine in the
PCS6422-capecitabine combination Phase 1B GI cancer trial
Financial Results for
the second quarter
of 2021
Our cash and cash equivalents totaled $20.8
million as of June 30, 2021, compared to $15.4 million as of
December 31, 2020 and we had 15.6 million shares of common
stock outstanding as of August 2, 2021.
Our research and development expenses for the
three months ended June 30, 2021 were $1.6 million compared to $427
thousand for the three months ended June 30, 2020. General and
administrative expenses for the three months ended June 30, 2021
were $1.3 million compared to $375 thousand for the three months
ended June 30, 2020. Our total stock-based compensation included in
general and administrative expenses for the three months ended June
30, 2021 was $674 thousand compared to $87 thousand for the three
months ended June 30, 2020. We reported a net loss for the three
months ended June 30, 2021 of $3.2 million compared to a net loss
for the comparable prior year period of $733 thousand. Our net loss
per share for the three months ended June 30, 2021 was $0.20
compared to net loss per share for the three months ended June 30,
2020 of $0.13.
Conference Call Information
To participate in this event, please dial in
approximately 5 to 10 minutes before the beginning of the call.
Date: August 12, 2021Time: 5:30 p.m. ETToll Free: 888-506-0062;
Entry Code: 628453International: 973-528-0011; Entry Code:
628453Live
Webcast: https://www.webcaster4.com/Webcast/Page/2572/42137
Conference Call Replay InformationToll-free:
877-481-4010International: 919-882-2331Replay Passcode: 42137Replay
Webcast: https://www.webcaster4.com/Webcast/Page/2572/42137
About Processa Pharmaceuticals,
Inc.
Our mission is to develop drug products that
improve the survival and/or quality of life for patients with high
unmet medical need conditions. We are a development company, not a
discovery company, that seeks to identify and develop drugs for
patients who need better treatment options than presently exist for
their medical condition. To increase the probability of development
success, our pipeline only includes drugs which have previously
demonstrated some efficacy in the targeted population or a drug
with very similar pharmacological properties has been shown to be
effective in the population. We currently have three drugs in
various stages of clinical development: PCS499 for Ulcerative
Necrobiosis in Phase 2B; PCS3117 for metastatic pancreatic cancer
and non-small cell lung cancer in Phase 2B; and PCS6422 for
metastatic colorectal cancer and breast cancer in Phase 1B. The
PCS12852 IND for the treatment of gastroparesis will be submitted
in the third quarter of 2021. For more information, visit the
company’s website at www.ProcessaPharma.com.
For More Information:Michael
Floydmfloyd@processapharma.com(301) 651-4256
James CarbonaraHayden IR(646)
755-7412james@haydenir.com
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