On January 14, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported that the first patient has been dosed in the phase 2 study of cinrebafusp alfa (PRS-343), a 4-1BB/HER2 Anticalin-based bispecific for the treatment of HER2-expressing gastric cancer (Press release, Pieris Pharmaceuticals, JAN 14, 2022, View Source [SID1234605490]). The two-arm, multicenter, open-label phase 2 study is evaluating the efficacy, safety, and tolerability of cinrebafusp alfa in combination with ramucirumab and paclitaxel in patients with HER2-high gastric cancer and in combination with tucatinib in patients with HER2-low gastric cancer.

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Patients in the phase 2 study will receive a loading dose of 18 mg/kg in week one and three, followed by maintenance doses of 8 mg/kg (Q2W) for both arms in the study. The Company is targeting an ORR of at least 40% with meaningful durability in the HER2-low arm, for which it intends to present data later this year. In the HER2-high arm, the Company is targeting an ORR of at least 50% with meaningful durability. Pieris intends to present data for the HER2-high arm in 2023. Collaboration partners Lilly and Seagen will supply ramucirumab and tucatinib, respectively, under previously announced drug supply agreements.

"The dosing of the first patient in this next phase of development of cinrebafusp alfa marks an important milestone for patients afflicted by gastric cancer without adequate treatment options, and we look forward to further evaluating the potential of this drug," said Tim Demuth, M.D., Ph.D., Chief Medical Officer of Pieris. "We believe cinrebafusp alfa can provide differentiated treatment options for patients with gastric cancer via 4-1BB-mediated T-cell engagement, both in terms of efficacy and safety."

About Cinrebafusp Alfa:

Cinrebafusp alfa (PRS-343) is a 4-1BB/HER2 fusion protein comprising 4-1BB-targeting Anticalin proteins and a HER2-targeting antibody. The drug candidate is currently in phase 2 development for the treatment of HER2-expressing solid tumors. In phase 1 studies, cinrebafusp alfa has shown an acceptable safety profile at all doses tested with no dose-limiting toxicities. The bispecific also showed a dose response and a 4-1BB-driven mechanism of action based on clinical benefit and pharmacodynamic correlates.

On January 14, 2022 Hervé Affagard, CEO and co-founder of MaaT Pharma presented the company at the H.C. Wainwright Bioconnect Virtual Conference held January 10-13, 2022 (Presentation, MaaT Pharma, JAN 14, 2022, View Source [SID1234605489]).

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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.

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.

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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.

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:

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* Webcast

* Presentation