On December 22, 2020 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the 39th Annual J.P. Morgan Healthcare Conference (Press release, Horizon Therapeutics, DEC 22, 2020, View Source [SID1234573212]). Tim Walbert, chairman, president and chief executive officer, will present at 11:40 a.m. ET on Jan. 12, 2021.

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The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available following the event.

On December 22, 2020 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported it has entered into a definitive securities purchase agreement with Acorn Bioventures, LP, a biotech-focused fundamental investor (Press release, Cyclacel, DEC 22, 2020, View Source [SID1234573211]).

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Under the agreement, Acorn Bioventures has agreed to purchase in a registered direct offering 485,912 shares of common stock and 237,745 shares of newly designated Series B Preferred Stock (convertible into shares of common stock at a ratio of 1:5), and in a concurrent private placement, warrants to purchase 669,854 shares of common stock, for aggregate gross proceeds of approximately $7 million. The offering is priced at-the-market pursuant to the rules of The Nasdaq Stock Market. The warrants will be exercisable beginning twelve months following the date of issuance, will expire on the five-year anniversary of the date of issuance, and have an exercise price of $4.13 per share.

Cyclacel intends to use substantially all of the net proceeds of approximately $6.9 million from the registered direct offering and concurrent private placement to rapidly advance clinical development of CYC140, a Polo-like-kinase 1 (PLK1) inhibitor.

"We are very pleased to support Cyclacel as they continue to progress clinical development of their clinical-stage assets for patients with various types of cancer," commented Anders Hove, MD and Isaac Manke, PhD, of Acorn Bioventures. "Cyclacel’s value proposition focuses on fadraciclib, a CDK2/9 inhibitor, which has shown promising clinical activity and safety profile in patients with advanced cancers and CYC140, a PLK1 inhibitor. Extensive preclinical data support clinical investigation of CYC140 in a broad range of liquid and solid tumors."

"Acorn’s philosophy is centered on achieving long-term investment returns after evaluating the scientific and clinical merits of novel medicines," said Spiro Rombotis, President & Chief Executive Officer of Cyclacel. "We are excited by the prospect that our two internally-discovered molecules, fadraciclib and CYC140, can move forward in parallel. Our clinical development program will evaluate both agents across a broad spectrum of hematological and solid tumor types with the aim of offering novel alternatives to patients with unmet medical needs."

The common stock is being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-231923), previously filed with the Securities and Exchange Commission ("SEC") on June 3, 2019 and declared effective on June 21, 2019. Such shares of common stock are being offered only by means of a prospectus supplement. A prospectus supplement and the accompanying prospectus relating to the registered direct offering may be obtained, when available, on the SEC’s website at View Source or by contacting Cyclacel Pharmaceuticals, Inc.

The warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from registration requirements of the Act and such applicable state securities laws.

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 an 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 SCYNEXIS, Inc. (Nasdaq: SCYX) reported the closing of its previously announced underwritten public offering of common stock, pre-funded warrants and warrants (Press release, Scynexis, DEC 22, 2020, View Source [SID1234573210]). The shares and warrants were sold at a public offering price of $6.25 per share and accompanying warrants, and the pre-funded warrants were sold at a public offering price of $6.249 per pre-funded warrant and accompanying warrants. The total gross offering proceeds to SCYNEXIS from this offering were $85.0 million, before deducting the underwriting discount and other estimated offering expenses, and excluding the exercise of any pre-funded warrants or warrants. All of the shares of common stock, pre-funded warrants and warrants were offered by SCYNEXIS.

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At closing, SCYNEXIS issued 8,340,000 shares of its common stock, pre-funded warrants to purchase 5,260,000 shares of common stock, and two series of warrants to purchase an aggregate of 13,600,000 additional shares of its common stock. The pre-funded warrants were issued to certain purchasers who have elected to purchase them in lieu of shares of common stock in this offering, as those purchasers would otherwise have exceeded 19.99% (or such lesser percentage as required by the investor) beneficial ownership of SCYNEXIS common stock immediately following the offering. The shares of common stock, pre-funded warrants and warrants were issued separately. The Series 1 warrants to purchase up to 6,800,000 shares of common stock have a one-year term and an exercise price of $7.33 per share, and the Series 2 warrants to purchase up to 6,800,000 shares of common stock have a three-and-a-half-year term and an exercise price of $8.25 per share. The pre-funded warrants and the warrants in each series are exercisable immediately. The warrants were certificated and are being delivered to the investors by physical delivery following the closing. There is no established public trading market for the pre-funded warrants or the warrants, and SCYNEXIS does not expect a market to develop.

Guggenheim Securities, LLC and Cantor Fitzgerald & Co. served as joint book-running managers for the offering. Ladenburg Thalmann & Co. Inc. and National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (NASDAQ: NHLD), acted as co-lead managers for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, and WBB Securities LLC acted as co-managers for the offering.

A shelf registration statement relating to the securities being sold in this offering was filed with the U.S. Securities and Exchange Commission (the "SEC") on September 11, 2020, and was declared effective on October 1, 2020. The offering was made only by means of a preliminary and final prospectus supplement and accompanying prospectus. Copies of the preliminary and final prospectus supplements and accompanying prospectus relating to the proposed public offering may be obtained by contacting: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, or by telephone at (212) 518-9658, or by email to [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; mail: [email protected]. The final terms of the offering were disclosed in the final prospectus supplement filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.

In connection with the offering SCYNEXIS terminated its Controlled Equity OfferingSM Sales Agreements with Cantor Fitzgerald & Co. and Ladenburg Thalmann & Co. Inc.

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.