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

On December 19, 2023 NETRIS Pharma, a clinical-stage biopharmaceutical company developing next generation molecules targeting cancer resistance, reported that it has expanded its ongoing Series A reaching €24.4 million with the closing of a €7.5 million extension (Press release, Netris Pharma, DEC 19, 2023, View Source [SID1234638684]). This closing mainly consists of new investors, including EIC Fund, following selection for the EIC accelerator program.

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The proceeds will be used to reach all endpoints of its clinical development plan and for corporate development purposes. NETRIS Pharma is evaluating its lead asset NP137, a monoclonal antibody targeting NETRIN-1, in five clinical trials in combination with chemotherapies or immunotherapies as a new path to alleviate resistance to these therapies.

Christophe Guichard, NETRIS Pharma Chief Financial Officer, commented: "NETRIS Pharma continues to deliver on its overall development plan despite challenging times for biotech fundraising. This funding extension reflects the strong impact of the recent back-to-back publications in Nature highlighting the promising mode of action of our lead product NP137 and will take us to significant value inflexion points in the next 12 months from our five ongoing proof-of-concept clinical trials."

Along with this funding, the executive team has been strengthened with the appointment of Fabien Sebille as Chief Business Officer. Fabien will lead the business development activities for NETRIS Pharma, leveraging his experience in executive positions within private and public oncology biotech companies as well as his track record in both sell-side and buy-side transactions.

"The recruitment of Fabien is a further step in NETRIS Pharma’s growth in advance of the multiple clinical readouts expected in the coming months. We look forward to working together in raising the profile of company and strengthening our relationships with pharmaceutical companies and other strategic partners," indicated Patrick Mehlen, Chief Executive Officer of NETRIS Pharma.

To help prepare for the next steps of NETRIS Pharma’s clinical development strategy, Gabriela Gruia has been nominated to its Board of Directors. Gabriela has held many leadership positions within pharmaceutical companies, and more recently was Senior Vice President and Head of Regulatory Affairs Oncology at Novartis, based in the US. During her tenure, Gabriela was responsible for leading a world class oncology regulatory affairs organization of approximately 120 associates.

Jean-Pierre Bizzari, Chairman of the Board of Directors, commented: "This successful fundraising is a further demonstration of the progress NETRIS Pharma has achieved and the promise of its clinical development pipeline. On behalf of the Board, I’d like to welcome Gabriela to the Company. Gabriela brings a wealth of regulatory experience with an outstanding track record of overseeing the regulatory approval process for 12 NMEs in oncology. I look forward to further complementing our Board of Directors with additional leading individuals from the pharma industry to help guide NETRIS as we continue our rapid progress."

About NP137

NP137 is a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, the ligand binding to UNC5B Receptor. Most types of tumors produce an abnormal amount of Netrin-1, which prevents cells from entering apoptosis. Netrin-1 is also upregulated in the first phases of tumor Epithelial-to-mesenchymal Transition. After confirmation of an excellent safety profile in humans, NETRIS Pharma is currently actively recruiting in five clinical trials testing NP137 in specific cancer indications in combination with chemotherapy or immune checkpoint inhibitors. The anti-cancer promise of NP137 was validated in two back-to back Nature papers published in August 2023.