On February 3, 2023 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer,reported that the U.S. Food and Drug Administration (FDA or the "Agency") has responded to the Company’s Investigational New Drug (IND) Application to initiate in the U.S. an open-label, single arm Phase 3 pivotal clinical trial evaluating the safety and efficacy of MaaT013 in patients with steroid-resistant acute Graft-versus-Host Disease (aGvHD) (Press release, MaaT Pharma, FEB 3, 2023, View Source [SID1234626825]). The FDA letter indicates that the Agency agrees to a defined list of conditions that could enable clinical evaluation of MaaT013 in the U.S. These measures will be included, by the Company, in the IND filing. The communication therefore provides a path forward regarding MaaT Pharma’s "pooling" technology for this IND. The Company will promptly prepare a complete response letter and in the interim, the clinical hold remains.

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"We appreciate the FDA’s continued commitment and are satisfied that the Agency has provided a clear and, we believe, achievable roadmap for the MaaT013 IND," said Hervé Affagard, CEO and co-founder of MaaT Pharma. "The dialogue with the FDA remains constructive and positive as it lays the groundwork for the clinical evaluation of our pipeline in the U.S. We are confident about implementing the next steps and we will update investors in due course."

As announced in August 2022, the FDA had requested further clinical and manufacturing-related information including data on the safety and efficacy of the Company’s "pooling" technology approach (i.e., mixing donations from multiple donors to achieve higher richness, diversity, and better standardization of the product). The Company submitted to the FDA detailed responses to these requests as announced in the press release dated January 24, 2023. In parallel, and as a reminder, the Company continues the development of MaaT013 in Europe with its ongoing international multicenter open-label, single arm, pivotal Phase 3 trial "ARES" evaluating MaaT013, which is progressing as planned. A review by an independent data safety and monitoring board (DSMB), is expected in the first half of 2023 after enrollment of half of the patients in the study.

Separately from the information above, MaaT Pharma reported its cash position as of December 31, 2022, and its revenues for the fourth quarter of 2022.

Cash position[1]
As of December 31, 2022, total cash and cash equivalents were EUR 35.2 million, as compared to EUR 40.3 million as of September 30, 2022 and EUR 43.3 million as of December 31, 2021. The net decrease in cash over the fourth quarter 2022 was EUR 5.1 million reflecting financing of operations and the ongoing development programs fully in line with the plans. As announced in a press release on January 24, 2023, the Company has extended its cash runway to end of Q4 2023, as compared to end of Q3 2023 as previously announced.

Revenues in Q4 2023[1]
MaaT Pharma reported gross revenues of EUR 0.6 million for the quarter ended December 31, 2022, compared with EUR 0.4 million for the same period of 2021. Full year gross revenues for 2022 amount to EUR 1.4 million compared to EUR 1.0 million in 2021. Revenues correspond to compensation invoiced in relation to the compassionate access program, as approved by the French National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM).

[1] Unaudited data

On February 3, 2023 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases, reported that it has made an equity grant to a newly hired employee under its 2022 Inducement Plan (the "Inducement Plan") (Press release, Inovio, FEB 3, 2023, View Source [SID1234626824]).

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On February 2nd, 2023 (the "Grant Date"), the Compensation Committee of INOVIO’s Board of Directors approved the award of options to purchase an aggregate of 15,625 shares of common stock to a newly hired employee in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock option has an exercise price of ­­­$1.79, the closing price of INOVIO’s common stock on the Grant Date. The stock option will vest and become exercisable with respect to one-fourth of the shares underlying the stock option vested on the Grant Date, and an additional one-fourth of the shares underlying the stock option on the first, second, and third anniversaries of the Grant Date. The vesting of stock options will be subject to the employee’s continued employment with INOVIO on the applicable vesting dates. The award is subject to the terms and conditions of a stock option agreement under the Inducement Plan.

On February 3, 2023 Ensysce Biosciences, Inc. (NASDAQ:ENSC) (the "Company"), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, reported that it has entered into a definitive agreement for the purchase and sale of 3,571,431 shares of the Company’s common stock at a purchase price of $0.84 per share of common stock in a registered direct offering priced at-the-marked under Nasdaq rules (Press release, Ensysce Biosciences, FEB 3, 2023, View Source [SID1234626823]).

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In addition, in a concurrent private placement, the Company will issue warrants to purchase up to 3,571,431 shares of common stock. The warrants have an exercise price of $0.715 per share, are exercisable immediately following issuance and will have a term of five and one-half years from the issuance date.

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

The closing of the offering is expected to occur on or about February 6, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from this offering are expected to be approximately $3 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include funding capital expenditures and working capital and repaying indebtedness.

The shares of common stock described above (but not the warrants issued in the concurrent private placement or the shares of common stock underlying such warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-269157) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on January 17, 2023. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock 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.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

On February 3, 2023 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported that effective February 1, 2023, the compensation committee of the Company’s board of directors granted options to purchase an aggregate of 22,500 shares of the common stock of the Company to three newly hired employees with a per share exercise price of $8.65, the closing trading price on the grant date (Press release, Coherus Biosciences, FEB 3, 2023, View Source [SID1234626822]).

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The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company’s board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

On February 3, 2023 Avalo Therapeutics, Inc. (Nasdaq: AVTX) ("Avalo") reported that it has commenced a proposed underwritten public offering of shares of its common stock and warrants to purchase shares of its common stock (Press release, Avalo Therapeutics, FEB 3, 2023, View Source [SID1234626821]). All of the shares and warrants in the proposed offering are to be sold by Avalo. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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SVB Securities and RBC Capital Markets are acting as joint bookrunning managers for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-254000) that was declared effective by the Securities and Exchange Commission (the "SEC") on March 19, 2021. The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by phone at (800) 808-7525, ext. 6105, or by email at [email protected]; or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, or by telephone at (877) 822- 4089 or by email at [email protected].

The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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