On November 4, 2022 Pieris Pharmaceuticals, Inc. (the "Company") reported that entered into an Open Market Sale Agreement (the "Sales Agreement"), dated August 9, 2019, with Jefferies LLC ("Jefferies"), pursuant to which the Company may offer and sell shares of its common stock, from time to time, up to an aggregate amount of gross sales proceeds of $50.0 million through an "at the market offering" program (the "2019 ATM Program"), under a shelf registration statement on Form S-3 (File No. 333-226725) (Filing, 8-K, Pieris Pharmaceuticals, NOV 4, 2022, View Source [SID1234623105]).

In August 2021, the 2019 ATM Program expired, and the Company established a second ATM offering program (the "2021 ATM Program") under the Sales Agreement, pursuant to which the Company may offer and sell shares of its common stock, from time to time, up to an aggregate amount of gross sales proceeds of $50.0 million. As of November 4, 2022, the Company had offered and sold shares of its common stock with an aggregate offering price of approximately $33.6 million pursuant to the 2021 ATM Program.

On November 4, 2022, the Company and Jefferies entered into an amendment to the Sales Agreement (the "Amendment No. 1" and together with the Sales Agreement, the "Amended Sales Agreement") to provide for an increase in the aggregate offering amount under the Sales Agreement, such that as of November 4, 2022, the Company may offer and sell shares of its common stock having an aggregate offering price of up to $75.0 million pursuant to the prospectus supplement filed on November 4, 2022, exclusive of shares previously sold under the 2021 ATM Program. The material terms and conditions of the Sales Agreement otherwise remain unchanged.

Sales, if any, of the Company’s shares of common stock through Jefferies will be made by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including without limitation sales made directly on the Nasdaq Capital Market or any other existing trading market for its common stock. Jefferies will use commercially reasonable efforts to sell the shares from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions it may impose). The Company is not obligated to make any sales of shares under the Amended Sales Agreement.

The foregoing description of the material terms of the Amendment No. 1 is qualified in its entirety by reference to the full texts of each of the Sales Agreement, a copy of which was filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on August 9, 2019 and is incorporated herein by reference, and the Amendment No. 1, which is attached as Exhibit 1.1 hereto and is incorporated herein by reference.

The shares to be offered under the Amended Sales Agreement have been registered pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-258497) (the "Registration Statement"), and offerings for such shares will be made only by means of a prospectus supplement. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

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On November 4, 2022 Amgen (NASDAQ:AMGN) reported that it will present at the Credit Suisse 31st Annual Global Healthcare Conference at 3:50 p.m. ET on Wednesday, November 9, 2022 (Press release, Amgen, NOV 4, 2022, View Source [SID1234623104]). David M. Reese, M.D., executive vice president of Research and Development and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On November 4, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported that it will release its third quarter 2022 financial results on Wednesday, November 9, 2022, after the markets close (Press release, Lexicon Pharmaceuticals, NOV 4, 2022, View Source [SID1234623103]). Management will conduct a conference call and live webcast at 5:00 p.m. ET / 4:00 p.m. CT that day to discuss its financial and operating results and to provide a general business update.

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The dial-in replay will be available for 14 days following the call. An audio webcast will be available online at www.lexpharma.com/events, with a webcast replay accessible for 14 days after the call.

On November 4, 2022 EVERSANA reported at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition December 10-13 in New Orleans, Louisiana to explore the latest technology and research as well as a wide range of new products and services on display (Press release, EVERSANA, NOV 4, 2022, View Source [SID1234623100]). Meet with EVERSANA’s experts to learn how our innovative oncology commercialization model enables our partners to optimize their investments, minimize risk and increase speed to market.

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Manufacturers in the oncology space are faced with accelerating speed to market, securing access and affordability and creating stakeholder engagement among other challenges. Third-party partners utilizing traditional commercialization models remain unprepared to navigate these complexities and lack the flexibility to meet the unique needs of respective therapy types, creating a launch process that is too inefficient, cumbersome and costs upwards of $265M on average over the first five years.

Currently, 66% of drugs do not meet launch expectations. Now more than ever, a commercialization partner must have a deep bench of experts, an agile, fit-to-scale model, and assets and personnel to support a range of integrated commercialization services to strategize a successful go-to-market plan.

In response to the needs of the market, EVERSANA’s team of experts created a new way to navigate the most complex oncology commercialization challenges: EVERSANA COMPLETE Commercialization, which offers manufacturers an end-to-end commercial strategy, operational excellence and a success-sharing delivery model.

In addition, oncology manufacturers must have commercialization strategies aligned to the unique needs of each therapy type. EVERSANA offers an innovative commercialization model specific to product and patient needs using a system of archetypes that consider tumor type, how the product is administered and the impact of the product on the patient journey. We define the value story for products with our experts in access and evidence, and we leverage data and analytics to support appropriate messaging.

On November 4, 2022 CellCentric, a privately owned, clinical stage biotechnology company pioneering small molecule inhibition of p300/CBP to treat cancer, reported that the Chief Investigator of its haematological malignancies programme, Professor Tim Somervaille, will be presenting compelling pre-clinical and early phase clinical activity data for inobrodib (CCS1477) at the American Society of Haematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition 2022, in New Orleans on the 9-13th December (Press release, CellCentric, NOV 4, 2022, View Source [SID1234623019]).

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Presentation Details:

CellCentric has developed a first-in-class small molecule inhibitor drug, inobrodib, that targets twin cancer gene regulators, p300 and CBP. An extensive Phase I clinical programme has been undertaken, and a recommended Phase II dose and schedule (RP2D) as monotherapy has been established. At the RP2D, this novel drug has been shown to be well tolerated long term, delivering objective responses in multiple specific settings as monotherapy, including in relapsed refractory multiple myeloma (MM), acute myeloid leukaemia (AML) and lymphomas.

Inhibiting p300/CBP impacts the expression of key cancer drivers including MYC, IRF4 and the androgen receptor (AR). MYC and IRF4 are particularly important in the progression of certain blood cancers. CellCentric has demonstrated that its pioneering drug, inobrodib, has a direct impact on these key oncogenes.

Inobrodib is formulated as a capsule, taken orally. Patients appreciate being able to take medicines themselves, at home, with less impact on routines and quality of life.

Andrew Hughes, CellCentric Board member and previous head of global clinical Phase I/II oncology at AstraZeneca, said: "It is fabulous to see the pre-clinical promise of targeting p300/CBP translate into the clinic and deliver meaningful results for people with cancer. Many first in class compounds fail to achieve long term tolerability, as well as delivering efficacy. Targeting the bromodomain of p300/CBP is proving to have been the right drug discovery strategy."

Tim Somervaille, Professor of Haematological Oncology at Cancer Research UK Manchester Institute and The University of Manchester, Honorary Consultant Haematologist at The Christie NHS Foundation Trust and Chief Investigator of the multi-centre international inobrodib Haematological Malignancy study commented: "These initial data provide great promise for the potential clinical utility of inobrodib as monotherapy, to treat late stage multiple myeloma patients, who have few alternate choices. We are expanding our existing encouraging cohorts, and also testing inobrodib now in combination with existing standard of care agents."

As well as testing in heavily pre-treated, relapsed refractory haematological malignancy patients, CellCentric also has a study evaluating inobrodib for solid tumours, including late-stage prostate cancer, known to be driven by MYC and AR. The Company continues to explore the drug both as monotherapy and in combination with existing agents, in these additional settings. These data will be reported separately.