On October 18, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), ("Isofol" or the "Company"), reported that the prospectus prepared by the Company in connection with the listing on Nasdaq Stockholm has been approved and registered by the Swedish Financial Supervisory Authority (Finansinspektionen) (Press release, Isofol Medical, OCT 18, 2021, View Source [SID1234591478]). The prospectus contains updated financial information, due to regulatory requirements, attributable to the Company’s equity and liabilities as well as net indebtedness as of July 31, 2021. The prospectus is available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

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Prospectus and new financial information

On October 15, 2021 Isofol announced that Nasdaq Stockholm’s listing committee made the assessment that Isofol fulfills the applicable listing requirements and will approve an application for admission to trading of the Company’s shares on Nasdaq Stockholm, provided that certain customary conditions are fulfilled, including approval and registration of a prospectus by the Swedish Financial Supervisory Authority. The prospectus that has been prepared in connection with the listing was approved and registered today by the Swedish Financial Supervisory Authority and is now available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

The prospectus contains previously unpublished financial information attributable to Isofol’s equity and liabilities and net indebtedness as of July 31, 2021. The financial information, which is also outlined below, is presented due to regulatory requirements, according to which financial information regarding the capital structure must not be older than 90 days at the time of the prospectus’ publication. Note that only interest-bearing liabilities are reported in the tables below. The information has not been reviewed by the Company’s auditor.

Additional information about the listing

The first day of trading on Nasdaq Stockholm’s Main Market is planned to take place on Thursday, October 21, 2021 and the final day of trading on Nasdaq First North Premier Growth Market is expected to be Wednesday, October 20, 2021.

The Company’s shares will be traded with unchanged ticker ISOFOL and ISIN-code (SE0009581051). No new shares will be issued in connection with the shares being admitted to trading on Nasdaq Stockholm and the Company’s shareholders do not need to take any action in connection with the listing.

Advisors

Isofol has engaged Advokatfirman Vinge KB as legal advisor and Carnegie Investment Bank AB (publ) as financial advisor in connection with the listing on Nasdaq Stockholm.

The information was submitted for publication, through the agency of the contact person set out above, at 13:00 CEST on October 18, 2021.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On October 18, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the IND submission for the initiation of phase 2 clinical trial of efineptakin alfa (also known as TJ107/GX-I7/NT-I7) in combination with PD-1 antibody in patients with advanced solid tumors, including triple-negative breast cancer (TNBC) as well as head and neck cancers (Press release, I-Mab Biopharma, OCT 18, 2021, View Source [SID1234591477]).

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Efineptakin alfa is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7) developed as a T lymphocyte-booster for cancer-related immunotherapy. Efineptakin alfa is expected to show therapeutic effect as a combination therapy with immune checkpoint inhibitors due to its inherent properties to increase T-cells that are critical for tumor suppression. Treatment with efineptakin alfa has distinct advantages over other cytokines such as human IL-2 that have a narrow therapeutic window and cause serious adverse effects.

Efineptakin alfa has been tested as monotherapy and in combination with checkpoint inhibitors to treat advanced solid tumors in the U.S., South Korea and China. According to the data from the NIT-110 dose-escalation study presented at ASCO (Free ASCO Whitepaper) 2021, the combination of efineptakin alfa and pembrolizumab is safe and well-tolerated in patients with advanced solid tumors. It significantly increased T cell numbers in both the tumor microenviroment and the peripheral blood. At the SITC (Free SITC Whitepaper) 2020, data from the phase 1b/2 Keynote-899 study (NCT03752723) have shown that simultaneuous treatment of efineptakin alfa at 1200μg/kg with pembrolizumab (Keytruda) induced 27.8% ORR in patients with metastatic TNBC. In addition, interim results from the phase 1 trial (NCT03687957) in high-grade gliomas unresponsive to chemoradiotherapy showed a 1.3 – 4.1 fold increase in the absolute lymphocyte count (ALC) with a one-year survival rate of 83.3%.[1] Further, a China phase 1b trial (NCT04001075) in patients with advanced solid tumors will soon complete to facilitate further development of efineptakin alfa.

"Efineptakin alfa is the first rhIL-7 for cancer treatment and underscores I-Mab’s commitment to innovation. Oriented by patients’ needs, we look forward to initiating this important trial to accelerate the clinical development and deliver a potentially transformative solution to patients," said Dr. Joan Shen, CEO of I-Mab.

Efineptakin alfa is also being studied in another phase 2 clinical trial (NCT04600817) to evaluate its efficacy and safety in lymphopenic patients with newly diagnosed glioblastoma multiforme (GBM) who have been treated with standard concurrent chemoradiotherapy. The study is currently advancing rapidly with the first patient dosed in February 2021.

[1] Data can be viewed in NeoImmuneTech’s poster presentation at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting at the following link: View Source;fname=AX_7356756659.pdf&orifname=nit_ir%20presentation_asco2021_e.pdf

About Efineptakin alfa

Efineptakin alfa, also known as TJ107/GX-I7/NT-I7, is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. It emerged from Genexine’s proprietary hyFc platform for the discovering of long-acting biologics. I-Mab has acquired exclusive rights from Genexine to develop and commercialize efineptakin alfa in Greater China. Efineptakin alfa may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. Efineptakin alfa has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.

On October 18, 2021 ViewRay, Inc. (Nasdaq: VRAY) reported that the company will host a Virtual Clinical Data Event for Investors and Analysts on Thursday, October 28, 2021. The event will begin at 8:30 am ET / 5:30 am PT (Press release, ViewRay, OCT 18, 2021, View Source [SID1234591476]).

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The Virtual Clinical Data Event will be hosted by the ViewRay leadership team and will feature the clinical work of Dr. Michael Chuong MD, FACRO, Medical & Clinical Research Director, Dept of Radiation Oncology, Miami Cancer Institute, GI Service Lead, Department of Radiation Oncology, Miami Cancer Institute, Associate Professor, Vice Chair of Research and Education, Florida International University, and Dr. Himanshu Nagar, MD, radiation oncologist Assistant Professor, Weill Cornell Medicine, New York-Presbyterian.

Guests must register to participate in the event on the company’s website beginning on October 21, 2021. A replay of the event will be available on the company’s website following the event.

On October 18, 2021 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported the closing on October 18, 2021 of its initial public offering (the "Offering") of 5,000,000 shares of common stock at a price to the public of $14.00 per share for total gross proceeds of $70,000,000 before deducting underwriting discounts and commissions and estimated offering expenses (Press release, Lucid Diagnostics, OCT 18, 2021, View Source [SID1234591472]).

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In addition, Lucid has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock from Lucid at the initial public offering price less underwriting discounts and commissions.

Cantor and Canaccord Genuity are acting as joint book-running managers for the offering. BTIG and Needham & Company are acting as co-lead managers for the offering.

A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission ("SEC") on October 13, 2021. This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification or publication of an offering prospectus under the securities laws of any such state or jurisdiction.

The offering is being made only by means of a written prospectus. Copies of the prospectus related to the offering can be accessed by visiting the SEC website at View Source Alternatively, copies of the prospectus relating to the offering can be obtained from either of the following:

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 18, 2021 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, reported a clinical trial collaboration with the University of Rochester Wilmot Cancer Center and Puma Biotechnology (Nasdaq: PBYI), a biopharmaceutical company, to conduct a Phase 2 clinical trial (Press release, Celcuity, OCT 18, 2021, View Source [SID1234591471]).

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This open-label Phase 2 trial will evaluate the efficacy and safety of Puma’s drug, NERLYNX (neratinib), and Xeloda (capecitabine), a Genentech/Roche drug, in previously treated patients selected with Celcuity’s CELsignia HER2 Activity Test who have metastatic HER2-negative breast cancer. Under the agreement, The University of Rochester Wilmot Cancer Center will serve as the sponsor and Ajay Dhakal, M.D., a medical oncologist at the University of Rochester Medical Center, will serve as the principal investigator of this study. The University of Rochester Wilmot Cancer Center is one of the 51 NCI-Designated Comprehensive Cancer Centers in the U.S. tasked with developing new approaches to diagnosing and treating cancer.

"This clinical trial could play a key role in creating a new treatment paradigm for metastatic HER2-negative breast cancer patients with brain metastases," said Dr. Dhakal. "We are eager to begin working with Celcuity’s cutting-edge CELsignia technology to identify a new subset of patients who may respond to NERLYNX."

Puma will supply NERLYNX, its pan-HER inhibitor currently approved by the U.S. Food and Drug Administration (FDA) for early and late-stage HER2-positive breast cancer. Celcuity will provide its CELsignia HER2 Activity Test to select HER2-negative metastatic breast cancer patients with brain metastases who have hyperactive HER2-driven signaling pathways for the trial and will fund the patient-related trial costs. Based on its estimates of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after initiation of the trial followed by the final results 12 to 15 months later. Celcuity expects enrollment to begin by early to mid-2022.

The goal of the trial is to demonstrate that previously treated HER2-negative metastatic breast cancer patients with brain metastases who have hyperactive HER2 signaling tumors, as identified by the CELsignia test, respond to treatment with NERLYNX in combination with XELODA, a chemotherapy commonly used in metastatic breast cancer patients. Celcuity believes there is significant clinical interest in finding new diagnostic tests and targeted therapies for metastatic HER2- negative breast cancer patients with brain metastases.

"We are excited about the opportunity to collaborate with Dr. Dhakal, The University of Rochester Wilmot Cancer Center, and Puma Biotechnology on this important clinical trial," said Brian Sullivan, CEO and co-founder of Celcuity. "This will be our first collaboration to study metastatic breast cancer patients with brain metastases selected for treatment using our CELsignia HER2 Activity Test. Patients with HER2-negative breast cancer who have brain metastases have few good options today. Approximately 20% of the 280,000 HER2-negative breast cancer patients receiving drug treatment annually have tumors with hyperactive HER2 signaling.1 For these patients, this trial represents a critical step towards a potential new therapeutic option."