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2021 revenue: €10.9 million, a strong growth by +21% compared to 2020, and cash position of €4.8 million

On January 14, 2022 IntegraGen (FR0010908723 – ALINT – Eligible PEA PME), an OncoDNA group company specializing in the genomics of cancer and rare genetic diseases, which performs interpretable genomic analyses for academic and private laboratories, reported its unaudited revenue figures for the year 2021 (Press release, Integragen, JAN 14, 2022, View Source [SID1234605488]).

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The 2021 unaudited annual turnover amounts to €10.9m, a 21% increase compared to 2020 (€9m). This amount does not include the recharge of personnel costs to the parent company.

The growth is mainly generated by revenues coming from the partnership with the "Groupement Coopératif de Santé" (GCS) SeqOIA following the acceleration of patient sequencing and the expansion of indications. The Mutualized Microbiology (P2M) platform operated for the Institut Pasteur has been especially active in the context of the Covid-19 pandemic and the needs for variant sequencing, resulting in a doubling of volumes compared to 2020. Services provided by the Evry laboratory were stable over the period, especially due to relatively low activity in the first half, offset by an acceleration in the second. Finally, the bioinformatics software segment shows a slight decrease as a result of less prospecting efforts due to the pandemic.

Cash flow amounted to €4.8m on December 31st, 2021 compared to €5.1m at the end of 2020. Excluding non-recurring items, the company generated positive operating cash flow for the whole year. This position includes a State Guaranteed Loan (PGE) of €1.8m granted in 2020 as part of the pandemic and for which the repayment began in 2021.

Growth outlooks are confirmed thanks to the increased order book at the end of 2021, multi-year contracts in place and revenue synergies following the finalized integration of IntegraGen within the OncoDNA Group.

Bernard Courtieu, CEO of IntegraGen, stated: "In the delicate context of the pandemic, in particular for activities related to oncology, and the integration of IntegraGen within the OncoDNA Group, we are particularly proud to announce a new double-digit growth for IntegraGen’s turnover in 2021. This growth in activities is coupled with growth in the order book; the business outlook therefore allows us to look to 2022 with confidence and ambition. Once again this year, I would like to give a special thank you to all the employees and partners of the company, thanks to whom we exceeded, for the first time, the threshold of ten million euros in turnover".

The financial results for 2021 will be published on April 24th 2022.

Entry into a Material Definitive Agreement

On January 14, 2022, Plus Therapeutics, Inc. (the "Company") reported that entered into an Equity Distribution Agreement (the "Distribution Agreement") with Canaccord Genuity LLC (the "Agent"), pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $5,000,000 (the "Shares"), depending on market demand, with the Agent acting as an agent for sales (Filing, 8-K, Cytori Therapeutics, JAN 14, 2022, View Source [SID1234605487]). Sales of the Shares may be made by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended (the "Securities Act"), including, without limitation, sales made directly on or through the NASDAQ Capital Market. The Agent will use its commercially reasonable efforts to sell the Shares requested by the Company to be sold on its behalf, consistent with the Agent’s normal trading and sales practices, under the terms and subject to the conditions set forth in the Distribution Agreement. The Company has no obligation to sell any of the Shares. The Company may instruct the Agent not to sell the Shares if the sales cannot be effected at or above the price designated by the Company from time to time and the Company may at any time suspend sales pursuant to the Distribution Agreement.

The Company will pay the Agent a commission of up to 3.0% of the gross proceeds from the sale of Shares by the Agent under the Distribution Agreement. The Company has also agreed to reimburse the Agent for its reasonable documented out-of-pocket expenses, including fees and disbursements of its counsel, in the amount of $50,000. In addition, the Company has agreed to provide customary indemnification rights to the Agent.

The Offering will terminate upon the earlier of (1) the issuance and sale of all shares of the Company’s common stock subject to the Distribution Agreement, or (2) the termination of the Distribution Agreement as permitted therein, including by either party at any time without liability of any party.

Any sales of Shares under the Distribution Agreement will be made pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-249410), including the related prospectus, filed with the Securities and Exchange Commission (the "SEC") on October 9, 2020 and declared effective on October 19, 2022, as supplemented by the prospectus supplement dated January 14, 2022, and any applicable additional prospectus supplements related to the Offering that form a part of the Registration Statement. The aggregate market value of Shares eligible for sale in the Offering and under the Distribution Agreement will be subject to the limitations of General Instruction I.B.6 of Form S-3, to the extent required under such instruction. The Company intends to use the net proceeds from this offering for general corporate purposes and for working capital.

The foregoing description of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the Distribution Agreement, which is filed as Exhibit 1.1 to this report and is incorporated herein by reference. A copy of the legal opinion of Hogan Lovells US LLP regarding the legality of the issuance and sale of the Shares is filed as Exhibit 5.1 to this report and is incorporated by reference herein.

This Current Report on Form 8-K does not constitute an offer to sell or the solicitation of an offer to buy any Shares, nor shall there be any offer, solicitation or sale of any Shares, in any jurisdiction in which it is unlawful to make the offer, solicitation or sale.

40th Annual J.P. Morgan Healthcare Conference ? Modulus Discovery Presentation

On January 14, 2022 Co-Founder and Chief Executive Officer, S. Roy Kimura, Ph.D, shared details on Modulus Discovery reported that it’s portfolio and pipeline strategy, at the virtual 40th Annual J.P. Morgan Healthcare Conference (Press release, Modulus Discovery, JAN 14, 2022, View Source [SID1234605481]). The recording and slides of the presentation are available at the following links:

* Webcast

* Presentation

Clarity – Year in Review 2021

On January 14, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Company"), an Australianbased clinical stage radiopharmaceutical company developing next-generation products to address the growing need for the use of radiopharmaceuticals in oncology, reported to release its first Annual Newsletter as a listed entity for the calendar year ending 31 December 2021 (Press release, Clarity Pharmaceuticals, JAN 14, 2022, View Source [SID1234605475]).

Despite the unprecedented challenges imposed by the global pandemic, this year has been extraordinary for Clarity.

Not only have we completed the largest biotechnology Initial Public Offering (IPO) on the Australian Securities Exchange (ASX), raising $92 million, but also significantly progressed clinical development of our pipeline of Targeted Copper Theranostics (TCT), commencing three new trials this year (including two trials in prostate cancer), closing a diagnostic trial of SAR-Bombesin following the exciting preliminary results, and expanding the theranostic trial in neuroblastoma to five sites. To support our clinical growth and take full advantage of therapeutic, manufacturing and logistical benefits of TCT, Clarity has been actively extending its manufacturing and logistical footprint. We have also progressed our preclinical and discovery programs and continued bolstering our IP portfolio to support the comprehensive platform of TCT.

Our team is excited to further build on the important milestones we have achieved to date and continue delivering on our ultimate goal of developing better treatments for children and adults with cancer in the new year

FDA allows review of application for market approval for Xspray Pharma’s Dasynoc

On January 13, 2022 Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) reported that the US Food and Drug Administration (FDA) has agreed to review the company’s application for market approval for Xspray Pharma’s product candidate, Dasynoc (dasatinib) in the US under the 505(b)(2) process (Press release, Xspray, JAN 13, 2022, View Source [SID1234650014]).

In November 2021, Xspray Pharma submitted an application for market approval in the US of the product candidate Dasynoc to the FDA under the Section 505(b)(2) NDA process, the registration pathway that applies to improved drugs. After an initial review, the FDA has now agreed to conduct a comprehensive review of Xspray Pharma’s application.

"This gratifying news marks an important milestone for Xspray Pharma. We are ready to develop a portfolio of improved PKI drugs that could enable a better quality of life for patients while creating value for the company. This news is entirely in line with our expectations, since the amorphous structure of Dasynoc means that the product is an improvement over the current market leader," says Xspray Pharma’s CEO Per Andersson.

The FDA’s review of Dasynoc will be completed within ten months, but the time span could be altered depending on potential questions during the review process. The application will also be supplemented with lower dosages, at a time to be determined in consultation with the FDA. As previously communicated, Xspray Pharma estimates that a launch in the market, assuming approval from the FDA, could take place in 2023.

"We see a number of key advantages with Dasynoc for patients, physicians and payers. Xspray Pharma’s product can be administered at a lower dosage than the reference product, which is expected to yield fewer side effects in patients. Studies have also shown that the product is not affected by the pH value in the stomach, which is why in comparison to the reference product it can be used in combination with proton-pump inhibitors in the concurrent treatment of peptic ulcers – a commonly occurring need in patients. Xspray Pharma’s product has also displayed significantly lower variability, which means that uptake of the active substance into the body is even," Per Andersson says.

Xspray Pharma’s application consists of the results from the registrational studies on healthy volunteers, where bioequivalence was achieved at an approximately 30 percent lower dosage than the reference product Sprycel. The application includes Dasynoc for the treatment of acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML), which are blood cancer illnesses in an area where only one new drug has been registered over a ten-year period.