On December 22, 2020 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases (the "Company"), reported that is has filed with the French Autorité des marchés financiers (the "AMF") an amendment to its 2019 Universal Registration Document and that the AMF has approved on December 22, 2020 under the approval no. 20-616 a prospectus (the "Prospectus") made available to the public in connection with the admission on the regulated market of Euronext in Paris ("Euronext Paris") of a maximum aggregate of 17,522,016 new ordinary shares, each with a nominal value of €0.25 to be issued following the potential full bond conversion in accordance with the Conversion Ratio Modification (as defined below), of 3,185,821 convertible bonds into new shares and/or exchangeable for existing shares that would remain outstanding following the Partial Buyback (as defined below), which were issued by the Company on October 16, 2017 and due October 16, 2025, provided that the Bondholders accept to postpone the maturity date of the OCEANES (the "OCEANEs") (Press release, Genfit, DEC 22, 2020, https://ir.genfit.com/news-releases/news-release-details/genfit-renegotiation-oceanes-convertible-bond-terms-availability [SID1234573209]).

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The Prospectus specifies:

Of the 6,081,081 OCEANEs initially issued and outstanding on the date of the Prospectus, certain Bondholders have contracted to sell 2,895,260 OCEANEs to the Company for cancellation at a repurchase price of €16.40 (including the accrued interest of €0.30) representing a nominal amount of €85,699,696 or 47.6 % of the Company’s outstanding OCEANEs, of an aggregate nominal amount of €179,999,997.60, for an aggregate total amount of €47.48 million (the "Partial Buyback");
the Company proposes to the OCEANEs Bond holders (the "Bondholders") in conjunction with its shareholders (the "Shareholders") (with respect to the latter, only in regards to the Modification of the Conversion Ratio), (i) the modification of the initial conversion ratio from one (1) new or existing share for one (1) OCEANE to 5.5 new or existing shares for one (1) OCEANE (the "Modification of the Conversion Ratio"), (ii) the extension of the maturity of the OCEANEs from October 16, 2022 to October 16, 2025, (iii) the deferral of the start date of the early redemption period as set out in the terms and conditions of the OCEANEs to November 6, 2023 and (iv) the modification of the adjustment of the conversion ratio in the event of a tender offer targeting the shares of the Company in order to take into account the maturity extension of the OCEANEs (together, the "OCEANEs Adjustments" and together with the Partial Buyback, the "Transaction ).
The Modification of the Conversion Ratio is subject to the approval of the Shareholders in an extraordinary Shareholders general meeting, scheduled to convene on first notice on January 13, 2021, or if quorum cannot be achieved, on second notice, on January 25, 2021 (the "Shareholders’ Meeting").

The OCEANE Adjustments will be submitted for approval at the Bondholders meeting scheduled to convene on January 25, 2021 (the "Bondholders’ Meeting").

The two aspects of the Transaction are interdependent: the Partial Buyback will only occur if (i) the Shareholders’ Meeting approves the Modification of the Conversion Ratio and (ii) the Bondholders’ Meeting approves the OCEANEs Adjustments. The settlement date of the Partial Buyback would then occur following these two meetings.

After January 31, 2021, if the Transaction is not approved at the Shareholders Meeting nor the Bondholders Meeting, the Bondholders’ commitments to participate in the Partial Buyback will become null and void. Should the Transaction fail to be completed, the Company would be unable to repay the OCEANEs on their maturity date and would then have to consider alternative solutions in order to protect its interests.

For information purposes:

based on the Company’s outstanding equity as of June 30, 2020, following the issuance of a maximum of 17,522, 016 new sharesfor the conversion of all the OCEANEs, shareholders’ equity per share will be €2.23 on a non-diluted basis and €2.34 on a diluted basis.
based on the number of the Company’s shares at the date of the Prospectus, the impact of the issuance of a maximum of 17 522 016 new shares for the conversion of all the OCEANEs, will be, per share, 0.69 % on a non-diluted basis and 0.68 % on a diluted basis.
PROSPECTUS AVAILABILITY
Copies of the Prospectus, consisting of (i) the Company’s 2019 Universal Registration Document filed with the AMF on May 27, 2020 under the number D.20-0503, (ii) the Company’s Amendment to its Universal Registration Document filed with the AMF on December 22, 2020 under the number D.20-0503-A01 and (iii) the securities note in the French language (note d’opération, including a summary of the Prospectus) are available free-of-charge at the Company’s corporate headquarters (Parc Eurasanté, 885 avenue Eugène Avinée in Loos (59120), France), on the Company’s website (www.genfit.com) and the AMF’s website (www.amf-france.org).

This Prospectus has been established in accordance with Article 1 of Regulation (EU) 2017/1129 (the "Prospectus Regulation").

For information regarding risk factors, see the sections titled "Main Risks and Uncertainties " in chapter 2 of the Company’s 2019 Universal Registration Document or "Risk Factors" in Item 3.D. of the Company’s 2019 Annual Report on Form 20-F and "Risk Factors" in Section 2 of the Company’s Amendment to its Universal Registration Document, available in English on the Company’s website.

INDEPENDENT EXPERTISE
On December 22, 2020, the Company made available the report prepared by the Accuracy independent expert firm, which was appointed on a voluntary basis by the Company’s Board of Directors, to determine whether the financial terms of the Transaction for the Shareholders and the Bondholders are equitable.

The independent expert report is included, in full, in appendix 1 of the securities note (note d’opération) in the French language, is also available at the Company’s corporate headquarters (Parc Eurasanté, 885 avenue Eugène Avinée in Loos (59120), France), and on the Company’s website (www.genfit.com– Investors & Media – Financials – Shareholders Meeting – 2021 Shareholders Meeting), including a convenience translation in English.

The findings of the Accuracy report are as follows:

"The results of our analysis are as follows:

As part of the Transaction, the holders of the OCEANEs have agreed to sell a portion of their bonds at a 45% discount to their face value (€16.4 compared to €29.6). This discount remains logically lower than the discount observed on the market immediately prior to the Transaction (62% to the €11.0 trading price on September 30 2020), since this trading price fully accounts for the default risk that the Company is facing.
The Transaction will result, immediately, in a theoretical value transfer from the shareholders to the holders of the OCEANEs 2022, which we estimate at €77 million (as a consequence of the partial repurchase of the OCEANEs 2022 and then the resetting of the conversion price and a postponement of the maturity of the OCEANEs). However, the Transaction should also, by reducing the default risk the Company is facing and by giving it back more strategic and operational flexibility, have a short-term positive impact on the share price, which we however cannot precisely measure today. In addition, if the Transaction does not take place, the shareholders would almost certainly see the value of their shares reduced to nil by the end of 2022.
In 2025, if the value of the equity and equity-like instruments(OCEANEs) measured as a whole ranges between €100 million and €300 million, the shareholders’ return will be negative, while that of the holders of the OCEANEs 2022 will remain stable at around 40% (on the basis of the trading price of the OCEANEs before the Transaction). If, however, the value of the equity and equity-like instruments measured as a whole, crosses the €300 million threshold, the shareholders’ and of OCEANEs 2022 holders’ returns will both be positive, although OCEANEs holders’ return will exceed that of the shareholders.
Unsurprisingly therefore, the Transaction will have a more favourable mid-term theoretical financial impact for the holders of the OCEANEs 2022 than for the shareholders. However, we believe that the spread between these returns is reasonable in light of (i) the current leverage which the holders of the OCEANEs 2022 have, and (ii) the intrinsic risk level of each category of financial instrument. This is because the shares of the Company inherently carry more risk than the OCEANEs 2022. The realisation of a risk (the failure of a clinical trial) has a more significant impact on the return expected by the shareholders than on that expected by the holders of the OCEANEs 2022.
On this basis, we believe that the financial conditions of the Transaction are fair for the shareholders and for the holders of the OCEANEs 2022."

On December 22, 2020 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the U.S. Food and Drug Administration (FDA) has agreed to the submission of an NDA based on data from Cohort 2 of its Phase 2 clinical trial, ZENITH20, which evaluated previously treated patients with non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, DEC 22, 2020, View Source [SID1234573208]). The company also reported that its pre-specified primary endpoint in its Phase 2 clinical trial evaluating poziotinib in first-line NSCLC patients with EGFR exon 20 insertion mutations was not met in Cohort 3. Spectrum additionally reported that preliminary data from patients receiving 8 mg of poziotinib twice daily demonstrated meaningful improvement in tolerability as measured by adverse events and dosing interruptions.

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"The agreement with the FDA to proceed with the submission of a new drug application is a significant milestone for the poziotinib program," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The improved tolerability from the BID dosing could have a meaningful impact on the overall safety and efficacy profile of poziotinib in an area of high unmet medical need."

The company had a successful pre-NDA meeting with the FDA which resulted in an agreement to submit an NDA for poziotinib. During the meeting, Spectrum confirmed with the FDA that Cohort 2 data could serve as the basis of an NDA submission. The company will continue to work with the FDA as it prepares the application for submission in 2021. Cohort 2 enrolled 90 patients who received an oral once daily dose of 16 mg of poziotinib. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8% (95% Confidence Interval (CI), 18.9%-38.2%). The observed lower bound of 18.9% exceeded the pre-specified lower bound of 17%. The median duration of response was 5.1 months and the median progression free survival was 5.5 months. In this cohort, 87% of patients had drug interruptions with 11 patients (12%) permanently discontinuing due to adverse events. 13 patients (14%) had treatment-related serious adverse events.

"We are pleased that the FDA meeting confirmed that Cohort 2 data can serve as the basis of a NDA submission and our team is diligently working on preparing our file for submission in 2021," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "While Cohort 3 did not meet its pre-specified ORR endpoint, we are seeing evidence of clinical activity with a disease control rate (DCR) of 86% and progression free survival data of 7.2 months." Dr. Lebel added, "The preliminary data from Cohort 5 with 8 mg twice daily dosing is supporting our hypothesis that this new dosing paradigm improves tolerability substantially, with Grade 3 adverse events reduced by about a third. We believe that improved tolerability and reduced drug dosing interruptions are key to patients staying on the drug longer and could potentially enhance anti-tumor effectiveness across the various EGFR and HER2 cohorts. These early findings, if confirmed, could benefit the entire poziotinib program."

Cohort 3 of the ZENITH20 clinical trial enrolled a total of 79 patients who received an oral once daily dose of 16 mg of poziotinib. The median time of follow up of all patients was 9.2 months with 12 ongoing patients still on treatment. The intent-to-treat analysis showed that 22 patients had a partial response (by RECIST) and 68 patients had stable disease for an 86.1% DCR. 91% of patients experienced tumor reduction with a median reduction of 25.5%. The confirmed ORR was 27.8% (95% CI 18.4-39.1%). Based on the pre-specified statistical hypothesis for the primary endpoint, the observed lower bound of 18.4% did not meet the pre-specified lower bound of >20%. The median duration of response was 6.5 months and the median progression free survival was 7.2 months. The safety profile was similar with the type of adverse events observed with other second-generation EGFR tyrosine kinase inhibitors. Grade 3 treatment related rash was 33% and diarrhea was 23%. 94% of patients had drug interruptions with 6 patients (8%) permanently discontinuing due to adverse events.

Preliminary data from Cohort 5 for patients with exon 20 insertion mutations receiving 8 mg twice daily dosing shows improved tolerability versus patients who received the 16 mg once daily dose. The data from this cohort includes patients with both EGFR and HER2 mutations. In Cycle 1, the incidence of Grade 3 or higher treatment related adverse events (rash, diarrhea and stomatitis) decreased by 32% for patients receiving the 8 mg twice daily dose. In addition, dose interruptions were reduced by 38% for the 8 mg twice daily dose versus the 16 mg once daily dose. No new types of adverse events were observed with the twice daily dosing regimen.

Conference Call and Webcast

The company’s management will host a webcast and conference call today, December 22, 2020, at 4:30 p.m. ET / 1:30 p.m. PT. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 5036836. A live webcast of the call will be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the company and Hanmi in several mid-stage trials in multiple solid tumor indications.

About ZENITH20

The ZENITH20 trial is comprised of 7 independent cohorts. Cohorts 1 – 4 are each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR. Cohorts 5 – 7 are exploratory. In December 2019, the company reported that the primary endpoint for Cohort 1 (EGFR) was not met but clinical activity was seen. Based on the results of Cohort 1, the company has amended the protocol for ZENITH20 to explore additional twice-daily dosing regimens as well as lower single daily dosage. In September 2020, the company reported that Cohort 2 met its primary endpoint. Cohorts 4 – 7 are still enrolling patients.

On December 22, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that it received a positive determination from the Nasdaq Stock Market granting approval of the Company’s request to transfer its listing to the Nasdaq Capital Market from the Nasdaq Global Select Market (Press release, Advaxis, DEC 22, 2020, View Source [SID1234573207]). The Company’s securities will begin trading on the Nasdaq Capital Market effective at the start of trading on December 24, 2020. The Company’s shares will continue to trade on Nasdaq under the symbol "ADXS."

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The Company’s stock price has traded below the minimum bid price necessary to maintain its listing on the Nasdaq Global Select Market (and now, the Nasdaq Capital Market). On December 22, 2020, Advaxis received notification from Nasdaq that the Company has been granted an additional 180-day compliance period, or until June 21, 2021, to regain compliance with the minimum $1.00 bid price per share requirement of Nasdaq’s Marketplace Rule 5550(a)(2) (the "Rule"). Nasdaq’s determination to grant the additional 180-day compliance period was based on the Company meeting the continued listing requirements of the Nasdaq Capital Market with the exception of the bid price requirement, and the Company having provided written notice of its intention to cure the deficiency during the additional compliance period, including effecting a reverse stock split if necessary.

According to Nasdaq, if at any time before June 21, 2021 the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, the Company will regain compliance with the Rule and the matter will be closed.

If the Company does not meet the minimum bid requirement during the additional 180-day grace period, Nasdaq will provide written notification to the Company that its common stock will be subject to delisting. At such time, the Company may appeal the delisting determination to a Nasdaq Hearings Panel ("Panel"). The Company would remain listed pending the Panel’s decision. There can be no assurance that, if the Company does appeal a subsequent delisting determination by the Staff to the Panel, that such appeal would be successful.

On December 22, 2020 Genprex, Inc. (Nasdaq: GNPX) ("Genprex" or the "Company"), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported it has entered into a securities purchase agreement with a single healthcare-dedicated institutional investor for the purchase and sale of 3,116,884 shares of its common stock at a purchase price of $3.85 per share in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Genprex, DEC 22, 2020, View Source [SID1234573206]). No warrants will be issued in connection with the transaction. The closing of the offering is expected to occur on or about December 24, 2020, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-239134) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any 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.

On December 22, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported the publication of a manuscript on MGD019, an investigational PD-1 × CTLA-4 bispecific DART molecule, in Cell Reports Medicine (Press release, MacroGenics, DEC 22, 2020, View Source [SID1234573205]). MacroGenics’ DART platform allows for the creation of bispecific antibody-based molecules with the ability to bind to two distinct targets in contrast to a single target as supported by traditional monoclonal antibodies.

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The publication, Development and Preliminary Clinical Activity of PD-1-Guided CTLA-4 Blocking Bispecific DART Molecule, highlights key findings from the ongoing Phase 1 trial of MGD019 first-in-human study of patients with advanced solid tumors (NCT03761017) as well as data from mechanistic studies. Findings in mechanistic studies demonstrated that cells co-expressing PD-1 and CTLA-4 are abundant in the tumor microenvironment (TME) compared to normal tissues, supporting PD-1 and CTLA-4 co-blockade in treating solid tumor cancers. This observation suggests that targeting dual PD-1/CTLA-4-expressing cells may also provide an opportunity for increased selectivity of checkpoint blockade in the TME, while relatively reducing effects in normal tissues.

In vitro studies demonstrated that MGD019 may provide complete blockade of PD-1 together with tunable inhibition of CTLA-4, with greatly enhanced blockade of CTLA-4 activity on dual-antigen expressing cells, a potential advantage over PD-1 or CTLA-4 blockade with individual monoclonal antibodies. In addition, MGD019 was well tolerated in non-human primates following repeated intravenous (IV) administrations (four weekly doses) of MGD019 at dose levels of 10, 40 and 100 mg/kg, well exceeding the highest non-severely toxic dose reported for the combination of nivolumab and ipilimumab in this species.

These mechanistic data formed the basis for the on-going, first-in-human study demonstrating clinical activity and correlated pharmacodynamics. At the cutoff date of April 1, 2020, 33 patients representing 21 different advanced solid tumor types were treated, including 13 patients (39.4%) who had previously received checkpoint inhibitor therapy. Objective responses were reported in four patients (including one unconfirmed response) with tumor types typically unresponsive to conventional checkpoint inhibition. MGD019 was generally well-tolerated up to the top predefined dose level of 10 mg/kg, with no dose limiting toxicities (DLTs) observed and a safety profile generally consistent with that of anti-PD-1 monotherapy.

"Treatment with PD-1 and CTLA-4 inhibitors such as nivolumab and ipilimumab has been effective in several cancer indications; however, the combination is associated with significant toxicity," said Paul Moore, Ph.D., MacroGenics’ Vice President of Cell Biology and Immunology and the senior author on the paper. "The pre-clinical and clinical results published today demonstrated that MGD019 can mediate complete blockade of PD-1 with tunable blockade of CTLA-4, which is enhanced on dual-expressing cells, a potential advantage over blockade by combining individual monoclonal antibodies to PD-1 and CTLA-4. The early clinical data from the Phase 1 trial of MGD019 appear to indicate an acceptable safety profile and support further clinical investigation of MGD019 in cancer treatment."

About MGD019

MGD019 is an investigational, bispecific DART molecule that was designed to enable blockade of two immune checkpoint molecules expressed on T cells, PD-1 and CTLA-4. Based upon the establishment of a recommended Phase 2 dose (RP2D) from a dose escalation study, MGD019 is initially being evaluated in a dose expansion study in microsatellite-stable colorectal cancer and non-small cell lung cancer. MacroGenics retains global rights to MGD019.