On April 6, 2022 Celsion Corporation (NASDAQ: CLSN) ("Celsion" or the "Company"), reported it has entered into definitive agreements with institutional investors for the purchase and sale of 1,328,274 shares of its common stock at a purchase price of $5.27 per share in a registered direct offering priced at-the-market under Nasdaq rules, for gross proceeds of $7.0 million before deducting placement agent fees and expenses (Press release, Celsion, APR 6, 2022, View Source [SID1234611516]). The closing of the offering is expected to occur on or about April 8, 2022, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-254515) previously filed with the U.S. Securities and Exchange Commission (the "SEC") under the Securities Act of 1933, as amended, which was declared effective by the SEC on March 30, 2021. A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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 April 6, 2022 Celsion Corporation (NASDAQ: CLSN) a clinical-stage company focused on DNA-based immunotherapy and next generation vaccines and Medidata, a Dassault Systèmes company, reported that they will be presenting their findings on the use of a Synthetic Control ArmⓇ (SCA) in a completed Phase Ib dose-escalating study of GEN-1 in the neoadjuvant treatment of patients with Stage III/IV ovarian cancer (the OVATION 1 Study) at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) being held on April 8-13, 2022 in New Orleans, LA (Press release, Celsion, APR 6, 2022, View Source [SID1234611515]).

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In a poster presentation entitled "Phase IB trial efficacy estimates via a clinical trial synthetic control arm", taking place on Monday April 11th 2022 from 9 AM through 12:00 PM EST , Dr. Elizabeth Lamont will present the research team’s findings that demonstrate how comparing patients from a single-arm trial can help enhance understanding of treatment effects in advance of randomized trials, inform drug development and trial design, and increase the scientific value of early phase trials.

The Phase Ib OVATION I Study evaluated escalating doses of GEN-1 (36 mg/m2, 47 mg/m2, 61 mg/m2 and 79 mg/m2) administered intraperitoneally in combination with three cycles of neoadjuvant chemotherapy (NACT) prior to interval debulking surgery, followed by three cycles of NACT in the treatment of newly diagnosed patients with Stage III/IV ovarian cancer. GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an interleukin-12 (IL-12) DNA plasmid vector encased in a non-viral nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein.

"The Medidata Synthetic Control Arm provided reliable estimates of the efficacy endpoints, which allowed for a decrease in the number of patients needed to participate in the subsequent randomized Phase II trial. In addition to decreasing the burden on patients, this helped to accelerate trial timelines and decrease costs," said Dr. Nicholas Borys, Chief Medical Officer at Celsion. "This truly important progress will lead to further insights and advancements in future trials and, in the end, help bring treatments to patients faster."

A Synthetic Control Arm is a type of external control and is formed by carefully matching patients treated with a new investigational therapy to anonymized clinical trial patients from Medidata’s extensive repository of historical clinical trials using baseline demographic and disease characteristics. Using this advanced statistical methodology, Celsion and Medidata found that progression-free survival was prolonged for the patients treated with the investigational therapy GEN-1 along with standard of care chemotherapy in the OVATION 1 Study compared to well-balanced historic control patients treated with the same standard of care chemotherapy alone (Hazard Ratio=0.53, 95% Confidence Interval (0.16, 1.73). This larger than expected effect size led to a decrease in the number of planned patients for Celsion’s subsequent Phase II trial and was used in support of Fast Track Designation from the U.S. Food and Drug Administration (FDA) received in February 2021.

"Medidata Acorn AI is in a unique position to create fit-for-purpose synthetic controls because of access to a pool of more than eight million anonymized patients from 27,000+ previous clinical trials," said Ruthie Davi, Ph.D., vice president, Data Science at Medidata Acorn AI. "Our AACR (Free AACR Whitepaper) presentation with Celsion will show how the SCA can provide a scientifically rigorous comparison in scenarios where a control group is not part of the study design or hard to recruit or retain. We are proud to be working to decrease the patient burden, enhance scientific value, and accelerate studies."

On April 6, 2022 Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company, reported that two important milestones on advancing the speed and scale of its spatial phenotyping solutions, will be presented during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting in New Orleans, April 8 to 13 (Press release, Akoya Biosciences, APR 6, 2022, View Source [SID1234611514]). First, the company will showcase the industry’s first 100-plex dataset for deep spatial phenotyping at single cell resolution, across an entire tissue sample. Second, they will preview a new universal chemistry to enable accelerated validation of biomarkers discovered using deep spatial phenotyping.

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Powered by the high-speed imaging capabilities of PhenoCycler-Fusion, the company will showcase how a panel of 100+ markers mapped across whole slides, at single-cell resolution, can give us unprecedented insights into tumor-immune biology. In addition to the speed of imaging, the system has a proprietary file compression algorithm that can reduce file sizes from terabytes to gigabytes. This powerful combination makes it easier for cancer researchers to scale up their spatial discovery efforts with larger panels.

Complementing the 100-plex dataset, and first unveiled at Spatial Day in December 2021, the company will also preview its new universal chemistry for rapid biomarker validation. Because the 100-plex panel and universal chemistry workflows are grounded in the same barcoded antibodies, customers can discover novel biomarkers using PhenoCycler-Fusion and leverage the same chemistry to validate the resulting biomarkers on the Fusion, as a standalone system, at a capacity of 100+ samples per week. Providing cohesion and consistency of imaging methods, chemistry and data analysis will accelerate the translation of spatial discoveries into actionable biomarker signatures.

These novel datasets and customer case studies will be presented during Akoya’s Exhibitor Spotlight Theater, titled ‘Comprehensive Spatial Phenotyping: Mapping the Tumor Microenvironment at Scale’ on April 12 at 3 PM (CST).

Speakers include:

Sizun Jiang, PhD, Principal Investigator, Beth Israel Deaconess Medical Center
Bernard Fox, PhD, Harder Family Endowed Chair in Cancer Research, Earle A. Chiles Research Institute, Providence Cancer Center
Oliver Braubach, PhD, Head of Applications, Akoya Biosciences
"We are excited to demonstrate the rapid advancement of our spatial phenotyping solutions. The speed enabled by our platforms is a catalyst not just for biomarker discovery but also accelerates the pace of development of our internal R&D teams," said Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "We are looking forward to sharing these latest innovations at AACR (Free AACR Whitepaper) and at the AGBT Annual Meeting in June, we will be showcasing our advancements in multiomics and spatial transcriptomics."

To view the full list of 23 abstracts and posters and to register for the Exhibitor Spotlight Theater, please visit akoyabio.com/aacr2022.

On April 6, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference on Wednesday, April 13, 2022 at 8:45 a.m. ET (Press release, Bicycle Therapeutics, APR 6, 2022, View Source [SID1234611513]).

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A live webcast of the fireside chat will be accessible in the Investors and Media section of Bicycle’s Website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 90 days following the fireside chat date.

On April 6, 2022 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric, will participate in three upcoming investor conferences (Press release, Enveric Biosciences, APR 6, 2022, View Source [SID1234611512]):

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Benzinga Psychedelics Capital Conference
Date: Tuesday, April 19th at 11:10 a.m. ET
Location: Fontainebleau Miami Beach in Miami, FL
To attend, please register here.

Sequire Cannabis & Psychedelic Conference
Date: Wednesday, April 20th at 1:00 p.m. ET
Location: Virtual
To attend, please register here.

KCSA Psychedelics Investor Conference
Date: Wednesday, April 27th at 11:00 a.m. ET
Location: Virtual
To attend, please register here.

For more information about the conferences, or to schedule a one-on-one meeting with Enveric’s management team, please contact your appropriate representative, or send an email to KCSA Strategic Communications at [email protected].