On December 19, 2023 XOMA Corporation (Nasdaq: XOMA), the biotech royalty aggregator, reported that it has entered into a non-dilutive, non-recourse, royalty-backed loan for up to $140 million of capital with certain funds managed by the credit platform of Blue Owl Capital Inc. (NYSE: OWL) (Press release, Xoma, DEC 19, 2023, View Source [SID1234638689]).

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"The Blue Owl financing provides us with significant non-dilutive capital to drive shareholder value through stock repurchases and additional royalty and milestone acquisitions," stated Brad Sitko, Chief Investment Officer of XOMA. "This capital infusion comes at an opportune time given the existing state of the biotech funding market, providing us with an opportunity to accelerate the growth of our royalty and milestones portfolio, which currently consists of two marketed products, two programs in or near registration, five assets in Phase 3 development, and over 60 assets in earlier stages of development."

"Blue Owl’s Life Science efforts are focused on credit, royalty, and equity investments in innovative healthcare and life sciences companies and products. We recognize the value embedded in XOMA’s differentiated royalty and milestone aggregation business strategy. Our long-established relationship with XOMA’s management team gives us confidence that they can continue building a balanced portfolio of current and future royalty-generating assets. This financing establishes a long-term partnership with XOMA, as we help broaden their access to capital for royalty and milestone monetization opportunities," said Sandip Agarwala, Managing Director at Blue Owl Capital.

Terms of the Agreement

XOMA has drawn down $130 million in principal from Blue Owl and has the option to draw another $10 million should the royalties received from VABYSMO (faricimab) sales on or prior to March 15, 2026, exceed a predetermined amount. XOMA is obligated to make semi-annual interest payments at a fixed rate of 9.875% per year until the royalty-backed loan is repaid, at which time VABYSMO royalty payments will revert back to XOMA. The loan is repayable over a 15-year period, although XOMA may repay it in full at any time during that period, subject to the terms of the loan. Additionally, XOMA has issued to Blue

Owl warrants to purchase an aggregate of up to 120,000 shares of XOMA’s common stock in three equal tranches with strike prices of $35.00, $42.50, and $50.00 per share, respectively, resulting in implied premiums of 122%, 170%, and 217% to the price of XOMA’s common stock at closing, respectively.

Advisors

Gibson, Dunn & Crutcher LLP served as XOMA’s legal advisor while Blue Owl was advised by Cooley LLP.

On December 19, 2023 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported that it has priced an underwritten offering of 4,939,591 shares of common stock at an offering price of $4.42 per share, and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase 5,242,588 shares of its common stock at an offering price of $4.419 per pre-funded warrant, which would result in total gross proceeds of approximately $45.0 million, before underwriting discounts and commissions and offering expenses payable by Syros (Press release, Syros Pharmaceuticals, DEC 19, 2023, View Source [SID1234638688]). All shares and pre-funded warrants are being offered by Syros. Closing of the offering is expected to occur on or about December 21, 2023, subject to customary closing conditions.

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The financing included new and existing investors, including Bain Capital Life Sciences, Syros co-founder and founding investor Flagship Pioneering, Adage Capital Partners LP, Invus, Samsara BioCapital, Deep Track Capital, Blue Owl Healthcare Opportunities, DAFNA Capital Management LLC, as well as a life sciences-focused investment fund.

TD Cowen and Piper Sandler & Co. are acting as joint book-running managers for the offering.

The offering is being made pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on April 6, 2023 and declared effective by the SEC on April 28, 2023. The offering will be made only by means of the prospectus and prospectus supplement that form a part of the registration statement.

The final terms of the offering will be disclosed in a prospectus supplement to be filed with the SEC. Copies of the prospectus supplement and the accompanying prospectus relating to this offering, when available, can be obtained from Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by telephone at (833) 297-2926, or by email at [email protected] or from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at 800-747-3924, or by email: [email protected].

This press release does 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 19, 2023 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported the closing of its previously announced underwritten public offering of 12,432,431 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase 1,621,621 additional shares (Press release, Syndax, DEC 19, 2023, View Source [SID1234638687]). The public offering price of each share of common stock was $18.50. The aggregate gross proceeds to Syndax from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $230.0 million. Following the closing of the Offering, Syndax has 84,809,736 shares issued and outstanding as of December 19, 2023.

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Goldman Sachs & Co. LLC, J.P. Morgan, TD Cowen and Stifel acted as joint book-running managers for the offering. B. Riley Securities acted as manager for the offering.

The shares were offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs and Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by emailing [email protected] or by telephone at (833) 297-2926; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at (415) 364-2720 or by emailing [email protected].

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 19, 2023 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the safety and efficacy for more cancer patients, reported an interim analysis from its Phase 1b study of its Next Generation Capecitabine (NGC-Cap) (Press release, Processa Pharmaceuticals, DEC 19, 2023, View Source [SID1234638686]).

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"These initial data provide our first confirmatory clinical evidence that NGC-Cap is metabolized differently than capecitabine and, as a result, may offer significant improvements in safety and efficacy over capecitabine, a commonly used chemotherapeutic agent across multiple cancer indications. We are encouraged to be near completion of the Phase 1b trial as we make preparations for a subsequent Phase 2 trial with NGC-Cap," said David Young, Pharm.D., Ph.D., President of Research and Development at Processa.

Thus far in the Phase 1b study, patients have received doses of NGC-Cap ranging from 75 mg once a day to 225 mg twice a day, significantly less than the 1,600 mg to 2,500 mg twice a day dose administered for FDA-approved capecitabine. More importantly, these much lower doses for NGC-Cap result in 5-FU (5-fluorouracil, the main metabolite of capecitabine that further metabolizes into desirable cancer-killing molecules called anabolites and undesirable molecules called catabolites that cause unwanted side effects) exposure up to 10 times greater than the higher FDA-approved capecitabine doses due to NGC-Cap’s unique metabolic pathway. One would anticipate that the much greater 5-FU exposure would result in greater and/or more severe side effects when, in fact, the side effect profile for 5-FU exposures from NGC-Cap had a similar anabolite side effect profile to FDA-approved capecitabine.

In addition, the side effects associated with FBAL (fluoro-beta-alanine, the primary catabolite formed from the metabolism of 5-FU), such as hand-foot syndrome, that can lead to capecitabine intolerance, were almost non-existent, likely because FBAL exposure was approximately 1% of the exposure seen after FDA-approved capecitabine administration.

Important to FDA’s request that we evaluate multiple dosage regimens to determine an Optimal Dosage Regimen, the interim analysis also shows that an improvement in the side effect profile was observed at a 5-FU NGC-Cap exposure of 5-6 times greater than FDA-approved capecitabine.

"We are very encouraged with the interim results from the Phase 1b trial." added Dr. Young. "We also appreciate our recent interactions with FDA and their guidance on the future development of NGC-Cap, including determining the dosing regimens that will provide the best safety and efficacy profile for patients receiving NGC-Cap across many types of cancers. In addition, it is gratifying to receive confirmation from the FDA on NGC-Cap’s status as a new chemical entity, which may provide additional commercial advantages."

These data confirm that the metabolic pathways that regulate how NGC-Cap is processed in the body suggest NGC-Cap may offer higher efficacy at lower doses of the underlying capecitabine agent, while simultaneously offering a better safety profile from less production of the side-effect producing catabolite FBAL that causes many of the dose-limiting side effects from treatment with capecitabine alone. It is believed that NGC-Cap’s ability to inhibit the production of catabolites like FBAL is key to the success of NGC-Cap. Further clinical studies are needed to confirm these interim observations.

The Company will conduct a Fireside Chat on December 20, 2023 at 4:30PM ET to discuss these data in further detail and lay out the Company’s corporate strategy with regard to the NGC platform. Investors interested in listening may register early for the event at View Source This link will also connect listeners to the Fireside Chat when it goes live. Content from the Fireside Chat will be archived through June 20, 2024.

About Capecitabine Administered with PCS6422 (NGC-Cap)

NGC-Cap combines the administration of PCS6422, the Company’s irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with the administration of low doses of the commonly used chemotherapy capecitabine.

Capecitabine is the oral form of 5-FU and, along with 5-FU, is among the most widely used chemotherapy drugs available, particularly for solid tumors. When metabolized (after oral ingestion), it becomes 5-FU in the body, which, in turn, metabolizes to molecules called anabolites that actively kill duplicating cells, such as cancer cells, and to molecules called catabolites that only cause side effects. The presence of the DPD enzyme plays an integral role in the undesirable conversion of 5-FU to catabolites.

PCS6422 is a uracil analog that irreversibly inhibits DPD. PCS6422 is neither toxic nor active as a single agent in animals at comparable dose levels. However, when administered in combination with capecitabine or 5-FU, PCS6422 decreases the metabolism of 5-FU to the catabolites that only cause side effects.

On December 19, 2023 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that that its Chief Executive Officer, Michael Engsig will present at the 42nd Annual J.P. Morgan Healthcare Conference and is available for 1:1 investor meetings (Press release, Nykode Therapeutics, DEC 19, 2023, View Source [SID1234638685]).

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Date: Wednesday, January 10, 2024
Time: 3:45 pm PST
Webcast: View Source;kiosk=true

The presentation, as well as a live audio and archived webcast of the presentation can be accessed in the Investors section of the Company’s website: View Source