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Sapience Therapeutics Announces Poster Presentation on ST101 Efficacy, Long-Term Exposure and Safety in Phase 1-2 at 34th EORTC-NCI-AACR Symposium

On October 13, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that an abstract on Phase 1-2 clinical results of ST101 has been selected for presentation at the upcoming 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place October 26-28, 2022 in Barcelona, Spain (Press release, Sapience Therapeutics, OCT 13, 2022, View Source [SID1234621995]).

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Poster Presentation Details:

Title: "Efficacy signals, long-term exposure and safety data from a phase 1-2 study of a cell-penetrating peptide antagonist of CEBPβ, a novel target, in patients (pts) with refractory solid tumors"
Abstract Number: 230
Session Title/Code: Molecular Targeted Agents 2
Date/Time: Thursday, October 27, 2022, 10am-5pm

Regular abstracts are available on the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) website at Home Page – 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium.

About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 dose expansion. In the ongoing Phase 2 dose expansion, Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, castration-resistant prostate cancer and locally advanced or metastatic hormone-receptor positive breast cancer. In the ongoing dose escalation part of the study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients.

ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

West to Host Third-Quarter 2022 Conference Call

On October 13, 2022 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release third-quarter 2022 financial results before the market opens on Thursday, October 27, 2022, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, OCT 13, 2022, View Source;utm_medium=Email&utm_campaign=Investors_Email&utm_content=13_October_2022&utm_source=West+Pharmaceutical+Services%2C+Inc.&utm_campaign=48c7ec838b-EMAIL_CAMPAIGN_2022_03_31_10_50_COPY_01&utm_medium=email&utm_term=0_4b4b77d239-48c7ec838b-584006100&ct=t(EMAIL_CAMPAIGN_5_12_2022_16_15_COPY_01)#west-to-host-third-quarter-2022-conference-call [SID1234621994]).

The live audio-only webcast will be made available via the Company’s Investor Relations website https://bit.ly/3cgSM9S or by clicking here.

To participate in the conference call by asking questions to Management, please register in advance at https://bit.ly/3eipdG3. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that will be used to access the call.

Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

A replay of the conference call and webcast will be available on the Company’s website for 30 days.

Sigyn Therapeutics™ Discloses Trademark Applications to Register ChemoPrep™ and ChemoPure™ for Devices to Enhance Cancer Therapy

On October 13, 2022 Sigyn Therapeutics, Inc. ("Sigyn" or the "Company") (OTCQB: SIGY), a development-stage company focused on creating therapeutic solutions to address unmet needs in global health, reported that trademark applications to register ChemoPrepTM and ChemoPureTM have been filed with the United States Patent and Trademark Office ("USPTO") (Press release, Sigyn Therapeutics, OCT 13, 2022, View Source [SID1234621993]).

The intent-to-use trademark applications are related to a recent USPTO patent submission entitled: "SYSTEM AND METHODS TO ENHANCE CHEMOTHERAPY DELIVERY AND REDUCE TOXICITY". Chemotherapeutic agents are the most commonly administered drugs to treat cancer, which is the second leading cause of death in the United States. Despite therapeutic advances, treatment toxicity, drug resistance and inadequate tumor site delivery restrict the benefit of chemotherapy.

To overcome these challenges, the Sigyn patent describes a therapeutic device system whose primary objective is to enhance tumor site delivery of chemotherapy and reduce its toxicity. A secondary objective of the system is to reduce treatment dosing without sacrificing patient benefit, or conversely increase chemotherapy dosing without added toxicity. In concert with these objectives, the therapeutic system offers to inhibit the spread of cancer metastasis reported to be induced by the administration of chemotherapy.

The chemotherapy enhancement system is to be comprised of two blood purification technologies. ChemoPrepTM, administered prior to chemotherapy to optimize tumor site delivery and improve the benefit of ChemoPureTM, which is deployed post-chemotherapy to reduce treatment toxicity and inhibit the potential spread of cancer metastasis.

Pacira BioSciences Reports Preliminary Third Quarter 2022 Revenue of $167.5 Million

On October 13, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited revenues of $167.5 million for the third quarter of 2022, compared with $127.7 million for the third quarter of 2021 (Press release, Pacira Pharmaceuticals, OCT 13, 2022, View Source [SID1234621992]). The company’s revenues include net product sales of EXPAREL (bupivacaine liposome injectable suspension), ZILRETTA (triamcinolone acetonide extended-release injectable suspension), and the iovera° system. The company began recognizing sales of ZILRETTA in November 2021 after completing its acquisition of Flexion Therapeutics, Inc.

"The second half of the third quarter saw meaningful improvement in year-over-year EXPAREL growth trends, culminating with September average daily sales exceeding 2021 by 13 percent," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "EXPAREL utilization has continued to outperform the elective surgery market’s recovery with expansion taking place across all target markets and sites of care despite a challenging macro environment. For ZILRETTA and iovera°, recent trends show we are leveraging the complementary value proposition as demonstrated by increasing utilization in target markets. On the clinical and regulatory front, we have made strong progress and expect to deliver significant milestones across our product portfolio in the next 12 to 18 months, including the approval and launch of EXPAREL in additional nerve block indications. Looking ahead to the remainder of 2022 and beyond, we remain confident in our ability to achieve strong revenue growth, robust earnings, and continued leadership in opioid-sparing pain management."

Third Quarter and September 2022 Preliminary Revenue Highlights

EXPAREL net product sales were $132.6 million and $121.9 million for the third quarters of 2022 and 2021 and $45.0 million and $39.7 million for the months of September 2022 and 2021, respectively. EXPAREL average daily sales were 109 percent of the prior year for the third quarter of 2022 and 113 percent of the prior year for the month of September 2022. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. For the third quarter, the number of EXPAREL selling days were 64 in 2022 and 2021. For the month of September, the number of EXPAREL selling days were 21 in 2022 and 2021.
ZILRETTA net product sales were $26.5 million for the third quarter of 2022 and $8.6 million for the month of September 2022. ZILRETTA sales in the third quarter of 2021 occurred prior to the completion of the company’s acquisition of Flexion in November 2021.
iovera° net product sales were $4.5 million and $4.2 million for the third quarters of 2022 and 2021 and $1.9 million and $2.3 million for the months of September 2022 and 2021, respectively.
Sales and royalties related to a third-party licensee of bupivacaine liposome injectable suspension for use in veterinary practice were $3.9 million and $1.6 million in the third quarters of 2022 and 2021 and $2.0 million and $1.1 million for the months of September 2022 and 2021, respectively.
Since early 2020, the company’s revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact of the pandemic has diminished due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise.

The company is not providing 2022 revenue or gross margin guidance at this time given the continued uncertainty around labor shortages, COVID-19, and the pace of recovery for the elective surgery market. To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for EXPAREL, ZILRETTA, and iovera° until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira completed its acquisition of Flexion Therapeutics on November 19, 2021, which added ZILRETTA to its commercial offering.

The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the third quarter or full year 2022.

PTC Therapeutics to Host Conference Call to Discuss Third Quarter 2022 Financial Results

On October 13, 2022 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that the company will host a webcast conference call to report its third quarter 2022 financial results and provide an update on the company’s business and outlook on Thursday, Oct. 27, at 4:30 p.m. ET (Press release, PTC Therapeutics, OCT 13, 2022, https://ir.ptcbio.com/news-releases/news-release-details/ptc-therapeutics-host-conference-call-discuss-third-quarter-2022 [SID1234621991]).

To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call. The webcast conference call can be accessed on the Investor section of the PTC website at View Source A replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.