On May 25, 2021 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported a proposed underwritten public offering in which it intends to offer and sell shares of its common stock (Press release, OncoGenex Pharmaceuticals, MAY 25, 2021, View Source [SID1234580554]). In addition, Achieve intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the securities are being offered by Achieve. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Oppenheimer & Co. Inc. is acting as the sole book-running manager for the proposed offering. Lake Street Capital Markets, LLC is acting as the lead manager.

Achieve intends to use the proceeds from the offering to fund ongoing cytisinicline development, other clinical research and development and for working capital and general corporate purposes.

The securities are being offered by Achieve pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Oppenheimer & Co. Inc. Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by calling (212) 667-8055, or by emailing [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Achieve, 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 May 25, 2021 Novartis reported that the US Food and Drug Administration (FDA) has granted fast track designation for sabatolimab (MBG453) for the treatment of adult patients with myelodysplastic syndromes (MDS) defined with an IPSS-R risk category of high or very high risk in combination with hypomethylating agents. Fast track designation facilitates the development and expedites the review of drugs to treat serious conditions and fill unmet medical needs1 (Press release, Novartis, MAY 25, 2021, View Source [SID1234580553]).

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MDS, a group of rare and often underdiagnosed blood cancers, is characterized by a dysfunctional immune system and leukemic stem cell proliferation2-4.
Despite treatment with HMAs – the last treatment innovation in higher-risk (HR) MDS over the past 15 years – patients face poor outcomes, including a limited duration of response, and have a median overall survival rate of less than a year5,6.
Sabatolimab is a first-in-class investigational immuno-myeloid therapy that binds to TIM-3, a novel target expressed on multiple immune cell types and leukemic cells and blasts, but not on the normal stem cells that induce blood formation; it is in development for HR-MDS and acute myeloid leukemia (AML)7,8.
The STIMULUS clinical trial program includes multiple studies evaluating sabatolimab as part of different combination therapies in patients with MDS and AML, including the Phase II STIMULUS-MDS1, Phase III STIMULUS-MDS2, Phase II STIMULUS-MDS3 and Phase II STIMULUS-AML1 studies9-12.

On May 25, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported its participation at this upcoming investor conference (Press release, Nkarta, MAY 25, 2021, View Source [SID1234580552]):

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Jefferies Virtual Healthcare Conference
June 2, 2021
Fireside chat presentation: 3:30 p.m. ET

The live webcast of the presentation will be available on the Investors section of Nkarta’s website, www.nkartatx.com. A replay of the webcast will be archived on the website for approximately four weeks.

On May 25, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported it has received clearance to initiate its Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases (Press release, Moleculin, MAY 25, 2021, View Source [SID1234580551]). The first of several planned clinical sites is now open and the Company expects to begin patient enrollment.

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Soft tissue sarcomas are the most common form of sarcoma, accounting for an estimated 130,000 incident cases per year worldwide. While many sarcomas can be addressed through surgical removal, it is estimated that as many 20% to 50% of STS sarcomas will eventually metastasize to the lungs, where treatment can become more challenging. Recently published animal data suggests that the efficacy of the current standard of care chemotherapy (doxorubicin) may be limited due to its inability to accumulate sufficiently in the lungs. The use of doxorubicin and other currently approved anthracyclines for STS lung metastases is further limited due to their inherent cardiotoxicity, which limits the amount of anthracycline that can be given to patients.

Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of acute myeloid leukemia (AML), and the Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin. Annamycin is currently in development for the treatment of AML and STS lung metastases.

"We remain dedicated to advancing this program forward and are pleased to have received clearance to begin patient enrollment. With the data seen to-date, we believe Annamycin has the potential to be the first non-cardiotoxic anthracycline and address the limitations with current treatment options. Our clinical teams are diligently working to complete additional site initiations and get patient enrollment and dosing underway as efficiently and expeditiously as possible," commented Walter Klemp, Chairman and CEO of Moleculin.

The Phase 1b/2 study is a a multi-center, open-label, single-arm study that in Phase 1b will determine the maximum- tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) and safety of Annamycin and in Phase 2 will explore the efficacy of Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate. A minimum of 3 subjects for each dosing cohort will be enrolled in the Phase 1b portion of the study until an MTD is identified. A maximum of 25 subjects will be enrolled at the RP2D to further evaluate efficacy.

Based on a recently announced reimbursement grant awarded in Poland, the Company also expects a second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases to be initiated in 2021, which will be primarily investigator-funded in Europe.

Annamycin has been granted Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of STS lung metastases.

On May 25, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.65 per share of the company’s common stock for the third quarter of 2021 (Press release, Merck & Co, MAY 25, 2021, View Source [SID1234580550]). Payment will be made on July 7, 2021 to shareholders of record at the close of business on June 15, 2021.

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