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Processa Pharmaceuticals Announces Year end 2020 Results and Provides Corporate Update

On March 25, 2021 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient’s survival and/or quality of life, reported that financial results for the year ended December 31, 2020, and provides corporate update (Press release, Processa Pharmaceuticals, MAR 25, 2021, View Source [SID1234578943]).

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Dr. David Young, CEO and chairman of Processa, commented, "2020 was a transformational year for our company; we in-licensed three exciting programs with potential markets exceeding $1 billion for each drug, improved our balance sheet, strengthened our management team and Board, up-listed to Nasdaq, and prepared the foundation for successful execution for our three clinical stage programs. I am delighted to report that we anticipate the first patients to be dosed with PCS6422 and PCS499 in the second quarter of 2021 with interim data for PCS6422 near the end of Q3 and for PCS499 in the first quarter of 2022."

Recent Highlights and New Developments

Selected 5 U.S. clinical sites to enroll patients with ulcerative necrobiosis lipoidica for our Phase 2B trial "A Randomized, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of PCS499 in Treating Ulcerations in Patients who Have Necrobiosis Lipoidica." Two to three additional clinical sites will be selected in the future including sites outside the U.S.
Entered into an exclusive licensing agreement with Elion Oncology, Inc. to develop, manufacture and commercialize PCS6422 (eniluracil) globally. PCS6422 is an oral drug to be administered with fluoropyrimidine cancer drugs (e.g., capecitabine, 5-FU). PCS6422 is designed to decrease the breakdown of the cancer drugs, which, without such intervention, reduce to inactive metabolites or metabolites that are known to cause unwanted side effects and to interfere with the anticancer activity.
Entered into a licensing agreement with Yuhan Corporation, a publicly traded South Korean company, to license PCS12852, a small molecule drug in development for the treatment of gastroparesis and functional gastrointestinal motility disorders.
Entered into a licensing agreement with Aposense LTD to license PCS11T, a pro-drug of SN38, the active metabolite of the widely used cancer drug irinotecan, that deposits SN38 in the membranes of cancer cells preferentially over normal cells.
Appointed Dr. Khalid Islam to the Company’s board of directors.
Appointed Michael Floyd as the Company’s chief operating officer.
Uplisted to Nasdaq.
Closed an underwritten public offering of 4,800,000 shares of common stock for a price to the public of $4.00 per share with net proceeds of $17.1 million.
In February 2021 we closed a private placement with institutional and accredited investors for $10.2 million. We sold 1,321,132 shares of the common stock at a purchase price of $7.75 per share for $10.2 million in the private placement and received net proceeds of $9.9 million.
Upcoming Clinical Drug Development Milestones

First half of 2021

Phase 1B First Patient Dosed: PCS6422 (Cancer)
Phase 2 First Patient Dosed: PCS499 (Ulcerative NL)
Second half of 2021

FDA IND Submission: PCS12852 (GI/Gastroparesis)
Interim Cohort Results Begin: PCS6422
First half of 2022

• Interim Results: PCS499

• Phase 2A First Patient Dosed: PCS12852

Financial Results for the Year Ended December 31, 2020

General and administrative expenses were $3.3 million compared to $1.6 million for the year ended December 31, 2019. The increase in our general and administrative expenses was primarily due to stock-based compensation.

Research and development expenses totaled $3.2 million compared to $2.3 million for the year ended December 31, 2019.

We also recorded $8.7 million dollars of costs as the acquisition of in-process research and development related to licensing agreements we executed for PCS6422, PCS12852 and PCS11T. A total of $8.6 million of this amount was non-cash consideration.

Our net loss was $14.4 million, compared to a net loss of $3.4 million for the year ended December 31, 2019. During 2020 we recorded non-cash expenses of $8.6 million for acquired in-process research and development and $2.7 million of stock-based compensation costs.

As of December 31, 2020, the Company had cash and cash equivalents of $15.4. In February 2021, we closed a $10.2 million private placement receiving net proceeds of $9.9 million.

Following the close of the offering and related transactions the Company will have 15.5 million common shares outstanding.

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Herantis Pharma Published the Annual Report for the Financial Year 2020

On March 25, 2021 Herantis Pharma Plc ("Herantis"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative biologic and gene therapies, reported the annual report for 2020 (Press release, Herantis Pharma, MAR 25, 2021, View Source,c3313818 [SID1234577485]). The Annual Report contains financial statements and the report of the Board of Directors. The Annual Report is available in PDF format in Finnish and English as appendices to this release and on Herantis Pharma’s website: View Source

G1 Therapeutics’ COSELA™ (trilaciclib) Included in Two Updated National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology

On March 25, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that COSELA (trilaciclib) has been added to two updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines): the Treatment Guidelines for Small Cell Lung Cancer and the Supportive Care Guidelines for Hematopoietic Growth Factors (Press release, G1 Therapeutics, MAR 25, 2021, View Source [SID1234577359]). These guidelines document evidence-based, consensus-driven management to ensure that all patients receive preventive, diagnostic, treatment, and supportive services that are most likely to lead to optimal outcomes.

The NCCN Guidelines incorporate real-time updates in keeping with the rapid advancements in the field of cancer research and management. The development of these guidelines is an ongoing and iterative process based on a critical review of the best available evidence and derivation of recommendations by a multidisciplinary panel of experts in the field of cancer.

"The inclusion of COSELA in these NCCN guidelines is critical, as they are the standard resource for determining best course of treatment and supportive care for people living with cancer, and as such will enable healthcare providers to make informed decisions when treating patients with small cell lung cancer," said Raj Malik, M.D., Chief Medical Officer of G1 Therapeutics. "COSELA is an innovative product; it is the first and only proactive multilineage myeloprotection agent for use in extensive stage small cell lung cancer. We welcome the rapid and simultaneous inclusion in both updated guidelines which reinforces COSELA’s clinical utility and importance to patients."

The NCCN guidelines are made available free of charge to clinical professionals in the United States and internationally. In addition, patient resources including user-friendly versions of NCCN guidelines are available to patients and their families. For more information, visit View Source

About COSELA (trilaciclib)

COSELATM (trilaciclib) is the first and only myeloprotection therapy to help decrease the incidence of chemotherapy-induced myelosuppression. Administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy, COSELA helps proactively deliver multilineage myeloprotection to patients with extensive-stage small cell lung cancer (ES-SCLC) being treated with chemotherapy. COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC.

About Small Cell Lung Cancer

In the United States, approximately 30,000 small cell lung cancer patients are treated annually. SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general 5-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%, and for extensive stage (cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for ES-SCLC.

COSELA(trilaciclib) for Injection

INDICATION

COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

WARNINGS AND PRECAUTIONS

Injection-Site Reactions, Including Phlebitis and Thrombophlebitis

COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients.

Acute Drug Hypersensitivity Reactions

COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade £1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA.

Interstitial Lung Disease/Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA.

Embryo-Fetal Toxicity

Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis.

Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%).

Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each).

Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA.

The most common adverse reactions (³10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

DRUG INTERACTIONS

COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin).

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Race Initiates FTO-Directed Kidney Cancer Preclinical Study

On March 25, 2021 Race Oncology Limited ("Race") reported that it has entered into a new collaborative preclinical research program with The University of Newcastle (Press release, Race Oncology, MAR 25, 2021, View Source [SID1234577243]). The work will be led by eminent cancer researcher, Associate Professor Nikki Verrills, who successfully ran Race’s preclinical breast and ovarian cancer programs (ASX announcements: 24 November 2020, 23 February 2021, 9 March 2021).

This project will use cellular models to investigate Bisantrene as a novel treatment for clear cell renal cell carcinoma (ccRCC), a devastating form of kidney cancer. While there have been major improvements with kidney cancer treatment in recent decades, the five-year survival rate for advanced ccRCC is still as low as ~12%.

Bisantrene has recently been identified as a potent targeted inhibitor of the Fat Mass and Obesity associated protein (FTO). Previous studies have observed that FTO enzyme activity is essential for ccRCC survival and the inhibition of FTO can directly kill more than 90% of ccRCCs.

Race is pursuing Bisantrene therapies targeted at inhibiting FTO in both melanoma and clear cell renal cell carcinoma, as part of its Three Pillar strategy (ASX announcement: 30 November 2020). This work could lead to new kidney cancer treatments with improved safety and efficacy, especially for treatment resistant cancers.

The results of this study will support Phase II human trials of Bisantrene in ccRCC, currently scheduled to begin in Australia in early 2022.

This project is to start immediately with results expected to be reported over the coming 12 months as received by the Company.

"This is a very important project for Race and we are looking forward to collaborating further with Associate Professor Verrills. Recent scientific developments have identified Bisantrene as a potent targeted agent of FTO which offers the possibility of novel treatment options for patients with kidney cancer that can rapidly be translated into the clinic. We are excited about this research which will further our knowledge of Bisantrene and it adds to the FTO-directed preclinical work we have just initiated in melanoma."

Chief Scientific Officer, Dr Daniel Tillett
Kidney cancer remains one of the most dangerous cancers with approximately 73,750 cases in the USA and 4,193 in Australia in 2020, of which ccRCC makes up approximately 70% of all cases.

PCR Oncology Expands Clinical Trial Offering by Adopting Deep Lens AI-Solution, VIPER™

On March 25, 2021 PCR Oncology and Deep Lens reported a strategic partnership that will integrate artificial intelligence-based clinical trial screening and enrollment platform, VIPER, into the PCR Oncology network (Press release, PCR Oncology, MAR 25, 2021, View Source [SID1234577232]). VIPER uses proprietary cloud-based technology to facilitate, triage and accelerate the clinical trial recruitment process. Through this collaboration, PCR Oncology will be able to more effectively identify, screen and match oncology patients to precision-based clinical trials.

"PCR Oncology is extremely dedicated to advancing cancer research and has prioritized the expansion of our clinical trial program to be able to offer a broader range of studies to our patient community," said David Palchak, M.D. at PCR Oncology. "The VIPER platform will not only expedite the process for matching patients to existing trials, but it will also assist in bringing additional trials to the PCR network, thereby greatly improving access to care for cancer patients on the Central Coast."

PCR Oncology has a robust clinical trial and research program. It is the first and only location in California that is participating in the National Cancer Institute’s (NCI) Cancer Moonshot program, a five-year initiative designed to advance the knowledge and treatment of cancer via the collection and analysis of biospecimens and data from diverse patient populations across the U.S.

It is estimated that more than 15,000 oncology clinical trials are actively recruiting patients; yet participation in these trials is often as low as three percent. Certain barriers to enrollment — including limited study site capacity and narrow trial eligibility requirements — have been well documented; however, the percentage of patient participation in these trials has not increased significantly over time. VIPER automates the clinical trial screening process and seamlessly matches patients — at the time of diagnosis — to appropriate trials through the ingestion and analysis of customized genomic data, electronic medical records and pathology data. Deep Lens’ VIPER will be integrating directly to their EMR (iKnowMed), molecular data feed (from Caris and Foundation Medicine) and pathology feeds to automatically identify qualified patients for clinical trials. Like PCR Oncology, any iKnowMed practice can be easily integrated and can utilize VIPER and the Deep Lens screening services free of charge.

"We are delighted to be able to help PCR Oncology improve efficiencies and add value to their already comprehensive clinical trial program," said Greg Andreola, Chief Revenue Officer at Deep Lens. "The VIPER platform is designed to assist clinical trial study sites with the complexities involved in patient recruitment and enrollment, which will allow oncology teams to focus more exclusively on providing patient care."