AVECTAS Leads €7.23 million Consortium Awarded Part Funding From Disruptive Technologies Innovation Fund

On April 22, 2021 Avectas reported that it is leading a consortium which will invest €7.23 million, including €4.4 million awarded under the Irish Government’s Disruptive Technology Innovation Fund (DTIF), to develop a high-throughput scale of its proprietary cell engineering platform Solupore (Press release, Avectas, APR 22, 2021, View Source [SID1234578385]). With consortium partners Bluebridge Technologies and NIBRT, the project expands Avectas’ development towards commercialising an advanced large-scale, digitalised cell engineering platform optimised to manufacture ‘off-the-shelf’ cell-based therapies for cancer treatment.

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The Disruptive Technologies Innovation Fund (DTIF) is a €500 million fund established under Project Ireland 2040 and run by the Department of Enterprise Trade and Employment with support from Enterprise Ireland.

Headquartered in Ireland, with locations in Toronto, Canada and Cambridge, USA, Avectas collaborates with leading cell therapy businesses and research institutes to address their cell engineering challenges using its patented Solupore technology. Cell therapy is a rapidly evolving therapeutic approach for cancer. Immune cells are taken from donors, engineered to make them more effective and then administered to patients. This award will allow Avectas to expand its Solupore platform to manufacture next-generation allogeneic products that can be produced at scale for large numbers of patients.

Bluebridge Technologies will develop a digitalisation dimension for the platform through the project. They will design, build and test software components to underpin the manufacturing technology, highlighting the convergence of cell therapy manufacturing and digitalisation. NIBRT will test and validate the platform in the context of an end-to-end manufacturing process and will facilitate technology adoption by situating the Solupore platform at their world-class facilities. All parties will work synergistically to disrupt the manufacture and delivery of cell-based therapeutics to patients.

Avectas has previously won significant award support from the European Union (under the Horizon 2020 programme). The company is engaged in work programmes with several therapeutic companies and leading academic laboratories, including The Simon Laboratory at UC Davis, California, the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto and the new NK Cell Centre of Excellence at Karolinska Institute, Sweden.

Speaking today, Dr. Michael Maguire, CEO of Avectas, remarked, "cell-based therapies offer the extraordinary potential for the treatment of cancers, and we believe that our Solupore Platform will disrupt the current cell therapy manufacturing process and help make Ireland a world centre for this developing area". Prof. Niall Barron commented, ‘NIBRT is delighted to be involved in this exciting DTIF-funded project which will accelerate the development of transformative technology for manufacturing revolutionary new therapies which go beyond being just treatments and in many cases actually cure patients. This project is a perfect example of the innovation and ambition that exists in Ireland to be at the forefront of this exciting new field".

Garret Coady, CEO of Bluebridge Technologies, added, "BlueBridge Technologies is delighted to be part of this project, which will showcase the power and promise of digital technologies that have the potential, not only to enable the delivery of novel therapies but to do so viably, at scale."

Dr. Maguire thanked the Department of Enterprise, Trade and Employment for their support: "This is expensive but hugely valuable work which could not exist without the support of the Department and the DTIF. We are grateful for that support."

Genocea To Host First Quarter 2021 Corporate Update Conference Call & Webcast

On April 22, 2021 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported that it will host its first quarter 2021 financial results and corporate update conference call and live audio webcast on Thursday, April 29 at 8:30 a.m. ET (Press release, Genocea Biosciences, APR 22, 2021, View Source [SID1234585000]).

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Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 2191366. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source

A webcast replay will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days

Adaptimmune to Report Q1 2021 Financial Results and Business Update on Thursday, May 6, 2021

On April 22, 2021 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that financial results and provide a business update for the first quarter ended March 31, 2021, before the US markets open on Thursday, May 6, 2021 (Press release, Adaptimmune, APR 22, 2021, View Source [SID1234578336]). Following the announcement, the Company will host a live teleconference and webcast at 9:00 a.m. EDT (2:00 p.m. BST) that same day (details below).

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The press release will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. A live webcast of the conference call and replay can be accessed at https://bit.ly/2Ry9DdR.

To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) or
+1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (9271335).

Plus Therapeutics Reports First Quarter 2021 Financial Results and Business Highlights

On April 22, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, reported financial results for the first quarter ended March 31, 2021, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, APR 22, 2021, View Source [SID1234578354]).

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The Company’s lead investigational drug is Rhenium NanoLiposome (RNL), a radiotherapy in development for several rare cancer targets, including recurrent glioblastoma (GBM). RNL, currently being evaluated in the U.S. multi-center ReSPECT Phase 1 dose-finding clinical trial, is designed to safely, effectively, and conveniently deliver a very high dose of radiation directly to brain tumors.

"In the first quarter of 2021, we made meaningful progress in critical areas including advancing our drug development and manufacturing activities, refining our clinical understanding of RNL behavior in the glioblastoma patients and in seeking FDA feedback on potential new clinical indications for RNL," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics.

First Quarter 2021 Clinical Highlights

Company highlights during the first quarter of 2021 included:

Entering into a master services agreement (MSA) with Piramal Pharma Solutions for the development, manufacture, and supply of RNL intermediate drug product.
Completing the 6th dose escalation cohort, with 18 patients treated in ReSPECT, with concomitant increases in both RNL drug volume and radiation dose.
Beginning treatment in an expansion cohort at the 6th dose with higher drug flow rates and faster drug infusion times.
Submitting 2 RNL pre-IND meeting briefing packages to the U.S. Food and Drug Administration (FDA) for treatment of leptomeningeal metastases and pediatric brain cancers, specifically ependymoma, high-grade glioma, and diffuse intrinsic pontine glioma.
Expected Upcoming Clinical Milestones and Events for 2021

In upcoming quarters in 2021, the Company intends to focus on a number of additional business objectives and potential milestones:

Complete enrollment of the ReSPECT Phase 1 trial for RNL in recurrent glioblastoma.
Complete pivotal trial planning in conjunction with FDA feedback for RNL in recurrent glioblastoma.
Complete a pre-IND meeting with the FDA, execute IND-enabling studies, if needed, and move into clinical trials for new RNL indications.
Continue development and evaluation of additional external and internal drug development candidates to expand the drug development pipeline.
Continue to explore partnership opportunities for three clinical-stage investigational drugs: RNL, DocePLUS and generic DoxoPLUS.
First Quarter 2021 Financial Results

As of March 31, 2021, the Company’s cash balance was $14.4 million, compared to $8.3 million as of December 31, 2020.
Total operating expenses for the first quarter of 2021 was $2.5 million, compared to total operating expenses of $2.56 million for the same quarter in 2020.
Net loss for the first quarter of 2021 was $2.7 million, or $(0.33) per share, compared to a net loss of $1.1 million, or $(0.28) per share, for the same quarter in 2020. The net loss was consistent year on year when excluding the book gains on the warrants reported in Q1 2020. Remeasurement of warrant liabilities was no longer required for Series U warrants that were amended in Q2 and Q3 2020 and reclassified to equity.
First Quarter 2021 Results Conference Call

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

Event: Plus Therapeutics First Quarter 2021 Results Conference Call
Date: Thursday, April 22, 2021
Time: 5:00 p.m. Eastern Time
Live Call: 877-402-3914 (toll free); 631-865-5294 (Intl.); Conference ID: 3084418
The webcast can be accessed live via the investor section of the Plus Therapeutics website at ir.plustherapeutics.com/events and will be available for replay beginning two hours after the conclusion of the conference call.

NeuBase Therapeutics Announces Pricing of $40 Million Public Offering of Common Stock

On April 22, 2021 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase"), a biotechnology company accelerating the genetic revolution with a new class of precision genetic medicines, reported the pricing of an underwritten public offering of 8,000,000 shares of its common stock, at a price to the public of $5.00 per share (Press release, NeuBase Therapeutics, APR 22, 2021, View Source [SID1234578370]). The gross proceeds to NeuBase from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by NeuBase, are expected to be approximately $40 million, excluding any exercise of the underwriters’ option to purchase additional shares of common stock. In addition, NeuBase has granted the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of its common stock at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any. All of the shares of common stock in the offering are being sold by NeuBase.

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RBC Capital Markets, Oppenheimer & Co. Inc. and Chardan are acting as the joint book-running managers for the offering, and National Securities Corporation is acting as co-manager.

NeuBase intends to use the net proceeds from the offering for general corporate purposes, working capital and development of its product candidates and pipeline expansion. This offering is expected to close on or about April 26, 2021, subject to the satisfaction of customary closing conditions.

The securities described above were offered by NeuBase pursuant to a shelf registration statement on Form S-3 (File No. 333-254980) previously filed with the Securities and Exchange Commission (the "SEC") on April 1, 2021 and declared effective by the SEC on April 14, 2021. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the offering has been filed with the SEC. Electronic copies of the preliminary prospectus supplement and, when available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting RBC Capital Markets, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, or by telephone at (877) 822-4089 or by e-mail at [email protected], Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055 or by e-mail at [email protected], or Chardan, 17 State Street, 21st floor, New York, New York 10004, by telephone at (646) 465-9032 or by e-mail at [email protected].

This press release does 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 the registration or qualification under the securities laws of any such state or jurisdiction.