On April 22, 2022 Novartis reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting marketing authorization of Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy (Press release, Novartis, APR 22, 2022, View Source [SID1234612866]).

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"Patients with alterations leading to METex14 skipping have an urgent need for treatment options, as this form of lung cancer is aggressive, often diagnosed in an advanced stage and frequently comes with a poor prognosis," said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne, Germany, and lead investigator of the GEOMETRY mono-1 trial. "The positive CHMP opinion for Tabrecta brings an option to patients for a treatment specific to their tumor. If approved by the European Commission, new targeted therapies like Tabrecta—supported by early and broad molecular testing of patients’ tumors—can better guide treatment decisions and ensure patients receive the appropriate therapy for their cancer."

The CHMP opinion is based on results from the Phase II GEOMETRY mono-1 trial that demonstrated positive overall response rates (ORR) among adult patients with advanced NSCLC whose tumors had alterations leading to METex14 skipping1. Based on data presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, among 31 patients who received Tabrecta as second-line therapy in the METex14 skipping pretreated population, a confirmed ORR of 51.6% (95% CI, 33.1-69.8) was achieved, and the ORR across all 100 previously-treated patients, which included patients who received one or two prior lines of systemic therapy, was 44.0% (95% CI, 34.1-54.3)1. The most common treatment-related adverse events (AEs) (incidence ≥20%)were peripheral oedema, nausea, fatigue, vomiting, dyspnea, decreased appetite and back pain1.

"Every 30 seconds, someone dies of lung cancer—the need for more treatment options is critical. Through research and targeted therapies like Tabrecta, we are working to change that statistic and make a positive impact on the lives of people affected by cancer around the world," said Marie-France Tschudin, President, Innovative Medicines International & Chief Commercial Officer, Novartis. "Today’s announcement represents an important step forward for people in the European Union with previously-treated advanced NSCLC having alterations leading to METex14 skipping."

In the European Union, there are an estimated 291,000 patients with locally advanced or metastatic NSCLC5. METex14 skipping, a recognized oncogenic driver, occurs in approximately 3-4% of NSCLC cases3,4.

About Tabrecta (capmatinib)
Tabrecta (capmatinib) is approved in several countries including the US, Switzerland and Japan. It is the number one prescribed targeted therapy for patients with advanced NSCLC with alterations leading to METex14 skipping globally2.

Tabrecta is a kinase inhibitor that targets MET. Tabrecta was discovered by Incyte and licensed to Novartis in 2009. Under the agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

About GEOMETRY mono-1
GEOMETRY mono-1 is a Phase II multi-center, non-randomized, open-label, multi-cohort study in adult patients with EGFR wild-type, ALK-negative rearrangement, advanced NSCLC with alterations that lead to MET exon-14 skipping who received 400 mg of capmatinib orally twice daily1.

Patients were assigned to cohorts on the basis of MET status and previous lines of therapy. The primary endpoint was overall response rate (ORR) based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The key secondary endpoint was duration of response (DOR) evaluated by BIRC1.

Mature data from the trial, including from an expansion cohort analysis, showed Tabrecta demonstrated a median duration of response of 9.7 months (95% CI, 5.6-13.0) in all previously-treated patients (n=100)1. In addition, Tabrecta demonstrated a median overall survival of 13.6 months (95% CI, 8.6-22.2) in previously-treated patients (n=69)1. The median progression-free survival was 5.5 months (95% CI, 4.2‑8.1) for all previously-treated patients (n=100) and 6.9 months (95% CI, 4.2-13.3) for patients who received Tabrecta as second-line therapy (n=31)1. The Disease Control Rate across all previously-treated patients was 82.0% (95% CI, 73.1-89.0)1. The expansion cohort analysis enrolled 160 patients with MET alterations and included previously-treated cohorts (n=100) who had been treated with one or two prior lines of systemic therapy for advanced disease, as well as treatment-naive cohorts (n=60)1.

Overall, Tabrecta demonstrated a manageable safety profile and there were no new safety signals or unexpected safety findings1. The most common treatment-related adverse events (AEs) (incidence ≥20%) were peripheral oedema, nausea, fatigue, vomiting, dyspnea, decreased appetite and back pain1.

About MET exon 14 skipping
MET (mesenchymal-epithelial transition), a receptor tyrosine kinase coded by the MET gene, normally plays an important role in cell signaling, proliferation and survival3. Many cancers are associated with abnormal signaling through the MET receptor pathway, caused by multiple mechanisms including point mutations, insertions and deletions that lead to skipping of exon 14. MET exon 14 (METex14) skipping is an oncogenic alteration in NSCLC that can result in overstimulation of the MET pathway3.

Patients with alterations that lead to METex14 skipping often have a poor prognosis due to the aggressiveness of the cancer and limited treatment options6-8.

Novartis and lung cancer
The needs in lung cancer are urgent and significant. Each year, more than 2 million people are newly diagnosed globally, and lung cancer remains the number one cause of cancer-related death worldwide9. There are two main types of lung cancer—small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC accounts for approximately 85% of lung cancer diagnoses10.

Novartis is making bold investments in advancing the science to drive treatment and make an impact for patients around the world. The company is committed to working with the scientific and medical communities to reimagine the treatment of lung cancer and pursue advances in medicine that could extend the survival of people living with lung cancer.

With one of the most diverse lung cancer development programs in the industry, Novartis is developing therapies that block cancer growth; learning more about ways to activate the body’s immune system; increasing understanding of the relationship between unregulated inflammation and tumor growth and recurrence; and exploring the potential for advanced nuclear medicine to fight the disease. Through these programs, Novartis aims to redefine possibilities in lung cancer and pursue a trajectory to make lung cancer history.

On April 22, 2022 Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options, reported that it has entered into definitive agreements with several institutional investors for the purchase of 9,339,436 shares of its common stock, at a purchase price per share of $0.25, for gross proceeds of approximately $2.3 million, in a registered direct offering (Press release, Salarius Pharmaceuticals, APR 22, 2022, View Source [SID1234612844]).

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Ladenburg Thalmann & Co Inc. is acting as the exclusive placement agent for the offering.
The gross proceeds to Salarius, before deducting placement agent fees and other offering expenses, are expected to be approximately $2.3 million. Salarius intends to use the net proceeds from this offering for the continued clinical and pre-clinical development of its product candidates, and for other general corporate purposes.

Additionally, Salarius has agreed to issue to the investors unregistered warrants to purchase up to 7,004,578 shares of common stock, with an exercise price of $0.3399. The warrants will be exercisable six months following the issuance date and will expire five and one-half years from the issuance date. The closing of the offering is expected to take place on or about April 26, 2022, subject to the satisfaction of customary closing conditions.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Salarius pursuant to a "shelf" registration statement on Form S-3 that was filed and declared effective by the Securities and Exchange Commission ("SEC") on May 17, 2019 and the base prospectus contained therein (File No. 333-231010). The offering of the shares of common stock will be made only by means of a prospectus supplement and accompanying base prospectus that form a part of the registration statement.

A prospectus supplement and accompanying base prospectus relating to the shares of common stock being offered will be filed with the SEC. Copies of the prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at www.sec.gov or by contacting Ladenburg Thalmann & Co. Inc., Attn: Prospectus Department, 640 Fifth Avenue, New York, NY 10019 or by 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 "Act"), and 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 the 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 April 22, 2022 SCYNEXIS, Inc. (Nasdaq: SCYX) reported that the pricing of its underwritten public offering of common stock, pre-funded warrants and warrants (Press release, Scynexis, APR 22, 2022, View Source [SID1234612845]). The shares and warrants are being sold at a public offering price of $3.00 per share and accompanying warrants, and the pre-funded warrants are being sold at a public offering price of $2.999 per pre-funded warrant and accompanying warrants. The gross offering proceeds to SCYNEXIS from this offering are expected to be approximately $45.0 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 are being offered by SCYNEXIS.

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At closing, SCYNEXIS will issue 3,333,333 shares of its common stock, pre-funded warrants to purchase an aggregate of 11,666,667 shares of common stock and warrants to purchase an aggregate of 15,000,000 shares of its common stock. The pre-funded warrants will be 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 our common stock immediately following the offering. The shares of common stock, pre-funded warrants and warrants will be issued separately. The warrants have a seven-year term and an exercise price of $3.45 per share. The pre-funded warrants and the warrants are exercisable immediately upon issuance. The warrants will be certificated and will be 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.

In addition, SCYNEXIS has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of common stock and/or warrants to purchase up to 2,250,000 shares of common stock, at their respective public offering prices, less the underwriting discounts and commissions.

Guggenheim Securities, LLC and Cantor Fitzgerald & Co. are serving as joint book-running managers for the offering. Ladenburg Thalmann & Co. Inc. and Maxim Group LLC are serving as co-lead managers for the offering. Aegis Capital Corp, Brookline Capital Markets, a division of Arcadia Securities, LLC, and WBB Securities LLC are serving 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 December 31, 2020, and was declared effective on January 8, 2021. The offering will be made only by means of a preliminary and final prospectus supplement and accompanying prospectus. When available, 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 Avenue, 8th Floor, New York, New York 10017, or by telephone at (212) 518-9544 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022, or by email at [email protected]. The final terms of the offering will be disclosed in the final prospectus supplement to be 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.

On April 22, 2022 Alligator Bioscience will host a conference call (in English) for investors, analysts and media on Wednesday, April 27, 2022, at 15:30 CET (Press release, Alligator Bioscience, APR 22, 2022, View Source [SID1234612805]). Alligator will publish the company’s interim report on Wednesday, April 27, 2022, at 8:00 CET.

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CEO, Søren Bregenholt and CFO, Marie Svensson will present the interim report for the period January – March 2022 Report followed by a Q&A session.

The conference call will be broadcast live on the web and can be accessed via the link: Alligator Bioscience , Audiocast with teleconference, Q1, 2022 | Financial Hearings

On April 22, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, and BioLexis Pte Ltd. ("BioLexis"), a strategic shareholder in Outlook Therapeutics, reported that BioLexis is being reorganized (Press release, Outlook Therapeutics, APR 22, 2022, View Source [SID1234616058]). The BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics, provides GMS Holdings with increased flexibility to support the future growth of Outlook Therapeutics as its largest shareholder.

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Pursuant to an agreement among BioLexis, GMS Ventures & Investments ("GMS V&I"), and certain of GMS V&I’s affiliates (GMS V&I and its affiliates, "GMS Holdings"), on April 21, 2022, GMS V&I has taken direct ownership of all of the shares of Outlook Therapeutics that were indirectly owned by GMS Holdings through BioLexis.

As the next step in the reorganization, GMS Holdings will cease to be a shareholder in BioLexis and BioLexis will be renamed "Tenshi Healthcare Pte Limited" (or such other name as may be approved by the regulatory authorities in Singapore). GMS Holdings does not have an economic interest in, or voting rights with respect to, the shares of Outlook Therapeutics that are held by BioLexis. BioLexis directly holds the shares beneficially owned by the minority shareholder in BioLexis, Tenshi Life Sciences Private Limited and Tenshi Life Sciences Pte Limited.

Since the initial investment by BioLexis in 2017, Outlook Therapeutics has undergone a significant transformation and has successfully completed three clinical trials which recently culminated in a BLA submission to the U.S. FDA on March 30, 2022. As the largest investor, GMS Holdings actively supported Outlook Therapeutics by leading and participating in multiple capital raises to support the Outlook Therapeutics growth strategy.

"The submission of a Biologics License Application (BLA) for ONS-5010 / LYTENAVA (bevacizumab-vikg) with FDA is a significant milestone to achieve and places Outlook Therapeutics on a path to potential marketing approval for a very promising therapy," said Faisal Sukhtian, Executive Director of GMS Holdings and a member of the Board of Directors of BioLexis. "With this milestone accomplished, the shareholders of BioLexis have fully realized their intended objectives for the joint venture. This reorganization will see the existing partners translate their joint ownership positions in Outlook Therapeutics into direct stakes."

"We appreciate the longstanding support we have received from BioLexis and look forward to executing on our priorities to create value for all shareholders," added Russell Trenary, President and CEO of Outlook Therapeutics.

In connection with the reorganization, Outlook Therapeutics and GMS Holdings entered into an Amended and Restated Investor Rights Agreement, which replaces the previous Investor Rights Agreement among Outlook Therapeutics, BioLexis and GMS V&I. BioLexis no longer has any rights under the Amended and Restated Investor Rights Agreement.