On November 15, 2019 Anchiano Therapeutics Ltd. (Nasdaq: ANCN) ("Anchiano" or the "Company"), a biopharmaceutical company focused on discovery and development of targeted therapies to treat cancer, reported the discontinuation of its Phase 2 Codex study evaluating the gene therapy inodiftagene vixteplasmid in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) (Press release, Anchiano Therapeutics, NOV 15, 2019, View Source [SID1234551370]). After a thorough analysis of the data, Anchiano determined that there is a low probability of surpassing the pre-defined futility threshold at the planned interim analysis, which required 10 complete responses in 35 patients. The data also indicate a low probability of achieving an efficacy profile that in the company’s estimation would be necessary to support regulatory approval.

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As of November 14, 2019, 16 patients were evaluable after the first disease assessment on treatment; of these, three (3/16, 19%) have experienced a complete response. The safety data on the investigational product were consistent with those observed in prior trials. Anchiano has taken steps to notify study investigators that enrollment and further treatment of patients on trial should stop immediately and will work to close the study in the coming weeks.

"We are disappointed by the results of the Codex study, as we recognize the urgent need for new effective therapies for patients with non-muscle-invasive bladder cancer. We thank the patients, caregivers and investigators involved in our clinical study," said Frank Haluska M.D., Ph.D., President and Chief Executive Officer of Anchiano.

The Company will devote its full resources to its small-molecule pan-RAS inhibitor and PDE10/β-catenin inhibitor programs. Anchiano recently acquired the option to exclusively license these programs from ADT Pharmaceuticals. The Company believes that the promise and value of these programs provide the greatest potential benefit for patients, and for shareholders, moving forward. The initial focus will be on accelerating the efforts to move the pan-RAS inhibitors toward the clinic. Oncogenic mutations in the RAS family of genes (KRAS, HRAS, and NRAS) are present in approximately 30% of all cancers. The Company believes that successful development of its pan-RAS-targeted therapy, with activity regardless of RAS isoform or mutation, has the potential for significant clinical impact across a variety of tumor types including lung, colorectal, pancreatic, melanoma and bladder cancer, and represents a substantial commercial opportunity.

Dr. Haluska added, "The decision to terminate Codex was made with strategic considerations in mind, and facilitates our efficiently redirecting resources and future investment into our pan-RAS inhibitor program. This is consistent with our commitment to develop targeted oncology therapies addressing significant patient populations."

On September 30, 2019, the Company had total cash and cash equivalents of approximately $23.2 million, compared to approximately $7.5 million on December 31, 2018. Financial resources are expected to suffice until the fourth quarter of 2020.

On November 15, 2019 Bruker Corporation (Nasdaq: BRKR) reported it will present at the following conferences (Press release, Bruker, NOV 15, 2019, View Source [SID1234551386]):

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Stifel 2019 Healthcare Conference, New York, NY
Tuesday, November 19, 2019, at 1:15 p.m. Eastern Time
Gerald Herman, Chief Financial Officer

Jefferies 2019 London Healthcare Conference, London, UK
Thursday, November 21, 2019, at 8:00 a.m. GMT
Gerald Herman, Chief Financial Officer

A live audio webcast of the Stifel 2019 Healthcare Conference presentation will be available in the Investor Relations section of the Company’s website at View Source A replay will be posted on the Bruker Investor Relations website after the event and will be available for 30 days following the presentation.

On November 15, 2019 Affibody Medical AB (publ) ("Affibody" or "the Company"), a Swedish biotechcompany focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod, reported its Interim Report for the third quarter of 2019 (Press release, Affibody, NOV 15, 2019, View Source [SID1234575700]).

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Financial Highlights

Revenue for the 3rd Quarter 2019 amounted to SEK 47.6 (25.6) m, and to 297.6 (85.1) m for the nine-month period
Operating result for the quarter amounted to SEK -17.5 (-58.0) m, and to 110.8 (-103.8) m for the nine-month period
Net result for the quarter amounted to SEK -6.0 (-57.7) m, and to 116.9 (-103.4) m for the nine-month period
Cash flow for the quarter amounted to SEK -27.9 (-30.6) m, and to 298.2 (-85.3) m for the nine-month period
Cash and cash equivalents at the end of the period amounted to SEK 389.2 (91.0) m.
Significant Events during the Reporting Period

In September Affibody announced its relocation to Campus Solna
In September a strategic collaboration with GE Healthcare to develop and commercialize Affibody-based PET imaging tracers, with initial focus on HER2 and PD-L1, was announced
In July, 2019 the completion of the planned 12 week interim analysis in the Company’s Phase 2 proof-of-concept study of its bispecific molecule ABY-035 for moderate-to-severe psoriasis ("AFFIRM-35") was announced.
Significant Events during the rest of the Year

The share issue was completed and fully subscribed in May and brought gross proceeds of SEK 147.4 m to the company
In March 2019, a partnership with Alexion Pharmaceuticals, Inc. to co-develop ABY-039, was announced. Under the terms of the agreement, Alexion has provided Affibody with an upfront payment of $25 million, with the potential for additional development- and sales-based milestones of up to $625 million and tiered low double-digit royalty payments. Alexion will lead joint clinical development of ABY-039 and commercialization activities. Affibody has the option to co-promote ABY-039 in the U.S. and will lead clinical development for an undisclosed indication
In February 2019, the Phase 2 proof-of-concept study of ABY-035 for moderate-to-severe psoriasis completed enrollment of patients.

On November 15, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions and nucleic acid-based biotherapeutic research, reported the closing of its previously reported underwritten public offering of 2,285,000 shares of common stock and warrants to purchase up to an aggregate of 2,285,000 shares of common stock (Press release, Applied DNA Sciences, NOV 15, 2019, View Source [SID1234551371]). Each share of common stock was sold together with one warrant to purchase one share of common stock at a combined effective price to the public of $5.25 per share and accompanying warrant. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, were approximately $12.0 million, not including any amounts received upon exercise of the warrants.

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The warrants are immediately exercisable at a price of $5.25 per share of common stock and will expire five years from the date of issuance. The shares of common stock and the accompanying warrants were sold together in the offering, but were issued separately.

Maxim Group LLC acted as the book-running manager and Joseph Gunnar & Co. LLC acted as a co-manager in connection with the offering.

Applied DNA has granted the underwriters a 45-day option to purchase up to an additional 342,750 shares of common stock and/or warrants to purchase up to 342,750 shares of common stock, at the public offering price less discounts and commissions.

The offering was conducted pursuant to the Company’s registration statement on Form S-1 (File No. 333-233830), as amended, previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC") on November 13, 2019 as well as the Company’s subsequent registration statement on Form S-1 (File No. 333-234664), which became effective on November 13, 2019. A final prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the final prospectus relating to this offering may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may 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 November 15, 2019 Centene Corporation (NYSE: CNC) ("Centene" or the "Company") reported that it has commenced an offering to sell $7,000,000,000 of senior notes. The $7,000,000,000 of senior notes will include an add-on to its 5.375% senior notes due 2026 (the "2026 Notes"), new senior notes due 2027 (the "2027 Notes") and new senior notes due 2029 (together with the 2027 Notes, the "New Notes" and, together with the 2026 Notes, the "Notes"), subject to market and other conditions (Press release, Centene , NOV 15, 2019, View Source [SID1234551387]). The 2026 Notes will constitute a further issuance of the $1,800,000,000 aggregate principal amount of 5.375% senior notes due 2026 that were issued on May 23, 2018 and will have the same terms as such notes, other than the issue date, the issue price and the first interest payment date.

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Centene intends to use the net proceeds of the New Notes to finance the cash consideration payable in connection with Centene’s previously announced acquisition of WellCare Health Plans, Inc. ("WellCare") and to pay related fees and expenses. Centene expects to use the net proceeds of the 2026 Notes for general corporate purposes, including the repayment of revolver borrowings. Centene currently expects the acquisition to be completed by the first half of 2020. The acquisition is, however, subject to customary closing conditions, and Centene cannot guarantee that the acquisition will be completed at or about such time, or at all. The closing of this offering is not conditioned on the closing of the acquisition. If the acquisition is not consummated, the Company will be required to redeem the New Notes at a redemption price equal to 100% of the principal amount of the New Notes, plus accrued and unpaid interest, if any, to but excluding the redemption date. The 2026 Notes will not be subject to a special mandatory redemption.

The Notes will be offered to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), and to non-United States persons outside the United States in compliance with Regulation S under the Securities Act. The Notes have not been registered under the Securities Act and may not be offered or sold in the United States without registration or an applicable exemption from the registration requirements.

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 the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration, qualification or exemption under the securities laws of any such jurisdiction.