OSE Immunotherapeutics Expands its Collaboration with MAbSilico to Use Artificial Intelligence to Accelerate Drug Development of Novel Antibody Therapeutics

On January 28, 2021 OSE Immunotherapeutics reported a new collaboration agreement with MAbSilico, a deep technology innovative TechBio located in Tours, France, to use artificial intelligence (AI)-based software for therapeutic monoclonal antibody drug development (Press release, OSE Immunotherapeutics, JAN 28, 2021, View Source [SID1234646990]).

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Nicolas Poirier, Chief Scientific Officer of OSE Immunotherapeutics, stated: "Expansion of our collaboration with MAbSilico to ten additional programs reflects our shared conviction that we can meaningfully improve and accelerate drug discovery, by pairing the knowledge and expertise of our R&D teams with the innovative technologies offered by MAbSilico. This perfectly complements the Company’s evolving business strategy to build a competitive development engine and bring more products into the clinic, hence accelerating and expanding our clinical stage portfolio in immunotherapy."

OSE Immunotherapeutics and MAbSilico entered into an initial agreement early 2020 to apply innovative AI-based solutions to six programs aiming at accelerating the characterization and optimization of monoclonal antibodies and therapeutic proteins for OSE to investigate as therapeutic agents.

Through this expanded agreement, both companies reinforce and extend the scope of the collaboration to use MAbSilico software for ten additional development programs of antibody drugs in immuno-oncology, inflammation and autoimmune diseases for OSE.

Furthermore, both companies are bringing together their unparalleled expertise in the field of AI and antibody-based therapies to develop a disruptive computational in silico Antibody Discovery and Design platform combining OSE’s database and expertise with MAbSilico’s AI-tools.

MAbSilico software, including AI, numerical simulation and data mining, is being used to guide therapeutic antibody discovery, help reduce the risk of failure and accelerate the preclinical development process of antibody drug candidates, with the objectives of speeding up the start of clinical testing.

This new collaboration between OSE Immunotherapeutics and MAbSilico aims to:
Accelerate the development of OSE’s "Immunotherapy 2.0" drug candidates by using AI, including machine learning and algorithms, at a very early stage in the process of monoclonal antibody discovery and optimization (AI-driven drug discovery); – Demonstrate how in silico software for computational antibody discovery and design can disrupt traditional drug development processes and timelines, from the selection of a promising epitope to the optimization of the final humanized lead. The very complementary knowledge of OSE’s antibody expertise, knowledge and databases with MAbSilico’s AI expertise and antibodydedicated deep tech technologies gathered in its integrated software, MAbFactory, is a revolution for antibody development.

QSAM Biosciences Closes Series B Preferred Private Placement; $2.5 Million in New Capital to Fund Upcoming Clinical Trials

On January 28, 2021 QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next-generation nuclear medicines for the treatment of cancer and related diseases, reported the successful closing of its Series B Preferred Stock private placement in the amount of $2.5 million (Press release, QSAM Biosciences, JAN 28, 2021, View Source [SID1234578424]). The offering was led by Checkmate Capital Group, LLC ("Checkmate Capital"), an investment firm based in California focused on biotechnology investments and other technologies.

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Proceeds from the Series B offering, which was over-subscribed, are expected to be used primarily to fund the Company’s upcoming clinical trials for its flagship drug candidate Samarium-153-DOTMP (aka CycloSam). The Company expects to file its IND with the U.S. Food and Drug Administration ("FDA") later this quarter to commence Phase 1 trials shortly thereafter.

"We are very pleased with the overwhelming interest in our offering, the proceeds from which will go directly into advancing the development of CycloSam. We are focused on several important value creating milestones in 2021, including commencement of clinical trials for CycloSam for indications that include both primary bone cancer, such as osteosarcoma, and secondary bone cancers that metastasize from the breast, lung, prostate and other areas. This funding will go a long way towards achieving these and other strategic goals," stated Douglas R. Baum, CEO and Co-Founder of QSAM.

"We are delighted to participate in this offering as a leading shareholder of QSAM. We have been impressed with the unique attributes of CycloSam’s radiologic cancer therapy, which, in animal studies, has demonstrated deep bone penetration followed by rapid exit of radioactive content from the body, as was reinforced by an FDA-approved, compassionate-use single human application," commented Tom Paschall, CEO of Checkmate Capital. "We have been further impressed with QSAM’s team of experts in nuclear medicine as well as the leading oncology centers with which QSAM is partnered."

The Series B preferred shares are convertible into an aggregate of approximately 16.6 million common shares and have voting rights alongside the common holders based on this conversion amount. Investors in the offering also received six-month, non-registered warrants to purchase an aggregate of up to 5.8 million shares of common stock at $0.35 per share. For its early investment and efforts to support the funding, Checkmate Capital received a 12-month warrant for 475,000 shares at $0.45 per share.

The Company also announced that it has moved its official headquarters from Florida to Austin, Texas.

Q4 2020 Report and presentation

On January 28, 2021 ArcticZymes Technologies (OSE: AZT) reported sales of NOK 22.1 million (16.3) and an EBITDA of NOK 6.8 million (4.9) for the fourth quarter of 2020. Underlying growth continues (Press release, Biotec Pharmacon, JAN 28, 2021, View Source [SID1234577313]).

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Highlights from Q4 2020

All financials figures are exclusive of discontinued operations (Biotec BetaGlucans)

ArcticZymes Technologies had Q4 sales of NOK 22.1 million growing by 35% (Q4 2019: NOK 16.3 million)
Coronavirus related sales are estimated at NOK 7.0 million in Q4 2020 (NOK 0 in Q4 2019)
Gross profit for ArcticZymes Technologies improved to NOK 21.5 million with 97% margin (Q4 2019: NOK 16.3 Million)
ArcticZymes Technologies delivered a positive EBITDA of NOK 6.8 million (Q4 2019: NOK 4.9 million)
Cash-flow for Q4 was positive NOK 80.2 million (Q4 2019: NOK 9.2 million) giving a cash balance of NOK 140.2 million (Q4 2019: NOK 31.2 million)
ArcticZymes Technologies becomes a pure enzymes company following the divestment of the Biotec BetaGlucans subsidiary to Lallemand Inc., with an Enterprise Value of NOK 70 million
CEO Jethro Holter comments:

"We are delighted that the enzymes business continues to drive strong quarterly sales growth and delivered on its promise to bring ArcticZymes Technologies into profitability during 2020. Both the therapeutics and combined molecular diagnostics (MDx)/molecular research segments have contributed towards growth in Q4. Furthermore, our expanding product range and customer base have been instrumental in fuelling underlying growth.

The divestment of the Biotec BetaGlucans subsidiary was successfully closed and pathed new directions for both Biotec BetaGlucans and ArcticZymes. This transaction thereby allows ArcticZymes Technologies to focus exclusively on the profitable enzyme business and enables additional investments in new infrastructure and personnel both of which will be key to drive innovation and to expand our existing product portfolio."

Calliditas announces termination of the proposed global offering

On January 28, 2021 Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX – CALTX; Nasdaq – CALT) reported that despite significant interest, it will not pursue the previously announced proposed global offering due to deterioration in market conditions (Press release, Calliditas Therapeutics, JAN 28, 2021, View Source [SID1234576686]).

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"This was an opportunistic capital raise against the backdrop of a strong overall market and communicated support from institutions. However, following the sudden and significant market deterioration seen yesterday, we no longer believe that it is in the interest of the company and its current shareholders to pursue the financing at this time," said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.

"Calliditas is well capitalized with a cash runway into Q3 of 2022 and we believe there are financing options which are more attractive than an equity issuance in the present volatile market circumstances. This decision does not have any impact on the our previously communicated plans with regards to our operations or development pipeline."

Cancer Genetics Announces $10.0 Million Private Placement Priced At-the-Market

On January 28, 2021 Cancer Genetics, Inc. (the "Company") (Nasdaq: CGIX), a leader in drug discovery and preclinical oncology and immuno-oncology services, reported that it has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $10.0 million through the issuance of an aggregate 2,758,624 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 2,758,624 shares of common stock, at a combined purchase price of $3.625 per share of common stock (or common stock equivalent in lieu thereof) and associated warrant in a private placement priced at-the-market under Nasdaq rules (Press release, Cancer Genetics, JAN 28, 2021, View Source [SID1234576606]). The closing of the private placement is expected to occur on or about February 1, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $3.50 per share, are exercisable immediately and have a term of five and one-half years.

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital and capital expenditures. The net proceeds are also expected to be available to the combined company once the previously announced merger with StemoniX closes, which is subject to stockholder approval.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

Under an agreement with the investors, the Company is required to file an initial registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock to be issued to the investors by 9:30 a.m., Eastern Time, on February 2, 2021 and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days after today in the event of a "full review" by the Securities and Exchange Commission.

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