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."

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."

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.

On 28 January 2021 mAbxience reported the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for two biosimilar medicinal products, bevacizumab (Alymsys) and bevacizumab (Oyavas), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix (Press release, mAbxience, JAN 28, 2021, View Source [SID1234575101]).

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The applicant for Alymsys is Mabxience Research SL. The applicant for Oyavas is STADA Arzneimittel AG.

Alymsys will be available as 25 mg/ml concentrate for solution for infusion. Oyavas will be available as 25 mg/ml concentrate for solution for infusion. The active substance of Alymsys and Oyavas is bevacizumab, a monoclonal antibody (ATC code: L01XC07). It binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, thereby inhibiting the binding of VEGF to its receptors on the surface of endothelial cells. Neutralising the biological activity of VEGF reduces vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.

Alymsys and Oyavas are biosimilar medicinal products. They are highly similar to the reference product Avastin (bevacizumab), which was authorised in the EU on 12 January 2005. Data show that Alymsys and Oyavas have comparable quality, safety and efficacy to Avastin (bevacizumab).

The full indications for Alymsys and Oyavas are:

in combination with fluoropyrimidine-based chemotherapy for the treatment of adult patients with metastatic carcinoma of the colon or rectum.
in combination with paclitaxel for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, it should be refered to section 5.1.
in combination with capecitabine for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Alymsys and Oyavas in combination with capecitabine. For further information as to HER2 status, it should be referred to section 5.1.
in addition to platinum-based chemotherapy for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology.
in combination with erlotinib, for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous NSCLC with epidermal growth factor receptor (EGFR) activating mutations.
in combination with interferon alfa-2a for first-line treatment of adult patients with advanced and/or metastatic RCC.
in combination with carboplatin and paclitaxel for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
in combination with topotecan, or pegylated liposomal doxorubicin for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.
It is proposed that Alymsys and Oyavas be prescribed by physicians experienced in the use of antineoplastic medicinal products.

Detailed recommendations for the use of these products will be described in the summaries of product characteristics, which will be published in the European public assessment reports and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinions are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinions.

On January 28, 2021 Onxeo S.A. (Euronext Growth: ALONX; Nasdaq First North: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, reported that it has secured a €5 million financing with a group of French banks, in the form of State Guaranteed Loans (Press release, Onxeo, JAN 28, 2021, View Source [SID1234575011]).

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This non-dilutive financing is part of the measures put in place by the French government to support French companies in the context of the COVID-19 pandemic. It will enable the Company to strengthen its cash position and extend its financial visibility through the 3rd quarter of 2022, taking into account programs already planned.

Nicolas Fellmann, Chief Financial Officer of Onxeo, commented: "We are very pleased with the commitment alongside our banking partners as well as Bpifrance and we would like to thank them. This significant financing allows the company to gain financial visibility good economic terms, while we are currently experiencing a challenging context. This funding secures the progress of our R&D programs with AsiDNA, which is currently being evaluated in two ongoing trials, and OX401, a new drug candidate from platON which has a particularly promising profile."

The loans are 90% guaranteed by the French government and have a maturity of 12 months. At the end of this initial period, the Company may, at its discretion, defer repayment of the principal amount for up to five additional years.