On April 22, 2022 This weekend, Madrid is hosting the "Generating Evidence and Sharing Experience (GESE)" Congress, organized by PharmaMar (MSE:PHM), reported that where leading European oncologists and medical specialists will meet to share the latest advances in the treatment and diagnosis of this disease (Press release, PharmaMar, APR 22, 2022, View Source [SID1234612864]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Soft Tissue Sarcoma (STS) is a group of solid tumors that can develop anywhere in the body, forming in soft tissues such as cartilage, fat, muscle, nerves, blood vessels or the deep tissues of the skin. Although STS can occur anywhere in the body, it usually occurs (43%) in the arms and legs.

Sarcoma is a type of cancer that encompasses more than 60 different subtypes. They are rare tumors that can appear at any time in life. Within localized sarcomas, the probability of survival, with appropriate treatment, is around 65% to 70%. This heterogeneity makes it difficult for specialists to decide on the treatment to combat the disease.

The attendees, experts from France, Italy, Germany, Austria, Holland, Switzerland, Portugal and Spain, will address topics such as the most avant-garde options for treatment, ultra-rare pathologies, new combinations, and the patient’s quality of life as an essential issue in the evolution of sarcomas, among others.

STS is one of the most difficult tumors to treat. Not only because of the difficulty required for its diagnosis -where the patient plays a very important role- but also because there are several different professionals who must deal with the treatment of these tumors in a multi-disciplinary manner.

On April 22, 2022 Orion’s collaboration partner Bayer reported the submission of a regulatory application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), for the oral androgen receptor inhibitor (ARi) darolutamide (Press release, Orion , APR 22, 2022, View Source [SID1234612863]). Bayer is seeking approval for the use of darolutamide for the treatment of adult patients with metastatic hormone sensitive prostate cancer (mHSPC) in combination with docetaxel. The compound is already approved under the brand name Nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease, in more than 60 markets around the world, including the U.S., the European Union (EU), Japan and China.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The CDE submission is supported by positive results from the Phase III ARASENS trial, showing a statistically significant improvement in overall survival (OS) for darolutamide plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC. These results were presented in February at the 2022 ASCO (Free ASCO Whitepaper) GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.

Darolutamide is developed jointly by Orion and Bayer. Additional submissions in mHSPC are planned by Bayer globally. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801).

About the ARASENS Trial

The ARASENS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial which was prospectively designed to investigate the efficacy and safety of oral darolutamide, an androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo, plus ADT and docetaxel.

The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all measured at 12‐week intervals, as well as adverse events (AEs) as a measure of safety and tolerability.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.1

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 5% of men will already suffer from prostate cancer with distant metastases when first diagnosed. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite these treatments, a large proportion of men with mHSPC will eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with limited survival.

About darolutamide

Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. A low blood-brain barrier penetration would explain the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial.

The product is approved under the brand name Nubeqa in more than 60 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801). Information about these trials can be found at www.clinicaltrials.gov.

On April 22, 2022 SCYNEXIS, Inc. (Nasdaq: SCYX) reported that the pricing of its underwritten public offering of common stock, pre-funded warrants and warrants (Press release, Scynexis, APR 22, 2022, View Source [SID1234612845]). The shares and warrants are being sold at a public offering price of $3.00 per share and accompanying warrants, and the pre-funded warrants are being sold at a public offering price of $2.999 per pre-funded warrant and accompanying warrants. The gross offering proceeds to SCYNEXIS from this offering are expected to be approximately $45.0 million, before deducting the underwriting discount and other estimated offering expenses, and excluding the exercise of any pre-funded warrants or warrants. All of the shares of common stock, pre-funded warrants and warrants are being offered by SCYNEXIS.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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At closing, SCYNEXIS will issue 3,333,333 shares of its common stock, pre-funded warrants to purchase an aggregate of 11,666,667 shares of common stock and warrants to purchase an aggregate of 15,000,000 shares of its common stock. The pre-funded warrants will be issued to certain purchasers who have elected to purchase them in lieu of shares of common stock in this offering, as those purchasers would otherwise have exceeded 19.99% (or such lesser percentage as required by the investor) beneficial ownership of our common stock immediately following the offering. The shares of common stock, pre-funded warrants and warrants will be issued separately. The warrants have a seven-year term and an exercise price of $3.45 per share. The pre-funded warrants and the warrants are exercisable immediately upon issuance. The warrants will be certificated and will be delivered to the investors by physical delivery following the closing. There is no established public trading market for the pre-funded warrants or the warrants, and SCYNEXIS does not expect a market to develop.

In addition, SCYNEXIS has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of common stock and/or warrants to purchase up to 2,250,000 shares of common stock, at their respective public offering prices, less the underwriting discounts and commissions.

Guggenheim Securities, LLC and Cantor Fitzgerald & Co. are serving as joint book-running managers for the offering. Ladenburg Thalmann & Co. Inc. and Maxim Group LLC are serving as co-lead managers for the offering. Aegis Capital Corp, Brookline Capital Markets, a division of Arcadia Securities, LLC, and WBB Securities LLC are serving as co-managers for the offering.

A shelf registration statement relating to the securities being sold in this offering was filed with the U.S. Securities and Exchange Commission (the "SEC") on December 31, 2020, and was declared effective on January 8, 2021. The offering will be made only by means of a preliminary and final prospectus supplement and accompanying prospectus. When available, copies of the preliminary and final prospectus supplements and accompanying prospectus relating to the proposed public offering may be obtained by contacting: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, or by telephone at (212) 518-9544 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022, or by email at [email protected]. The final terms of the offering will be disclosed in the final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 April 22, 2022 Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options, reported that it has entered into definitive agreements with several institutional investors for the purchase of 9,339,436 shares of its common stock, at a purchase price per share of $0.25, for gross proceeds of approximately $2.3 million, in a registered direct offering (Press release, Salarius Pharmaceuticals, APR 22, 2022, View Source [SID1234612844]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Ladenburg Thalmann & Co Inc. is acting as the exclusive placement agent for the offering.
The gross proceeds to Salarius, before deducting placement agent fees and other offering expenses, are expected to be approximately $2.3 million. Salarius intends to use the net proceeds from this offering for the continued clinical and pre-clinical development of its product candidates, and for other general corporate purposes.

Additionally, Salarius has agreed to issue to the investors unregistered warrants to purchase up to 7,004,578 shares of common stock, with an exercise price of $0.3399. The warrants will be exercisable six months following the issuance date and will expire five and one-half years from the issuance date. The closing of the offering is expected to take place on or about April 26, 2022, subject to the satisfaction of customary closing conditions.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Salarius pursuant to a "shelf" registration statement on Form S-3 that was filed and declared effective by the Securities and Exchange Commission ("SEC") on May 17, 2019 and the base prospectus contained therein (File No. 333-231010). The offering of the shares of common stock will be made only by means of a prospectus supplement and accompanying base prospectus that form a part of the registration statement.

A prospectus supplement and accompanying base prospectus relating to the shares of common stock being offered will be filed with the SEC. Copies of the prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at www.sec.gov or by contacting Ladenburg Thalmann & Co. Inc., Attn: Prospectus Department, 640 Fifth Avenue, New York, NY 10019 or by e-mail at [email protected].
The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws.

Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

On April 22, 2022 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported that it will host a conference call on Monday, April 25, 2022 at 8:00 a.m. ET to review clinical data from its ongoing Phase 1 clinical trials assessing two lead clinical programs, NKX101 and NKX019 (Press release, Nkarta, APR 22, 2022, https://ir.nkartatx.com/news-releases/news-release-details/nkarta-host-conference-call-highlighting-preliminary-clinical [SID1234612842]). Leading investigators from the two clinical trials will join management for the discussion.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference Call and Webcast

To access the conference call, please dial:

+1 (866) 518-6930 (domestic)
+1 (203) 518-9797 (international)
Conference ID "Nkarta"

A simultaneous webcast of the conference call and accompanying slides will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately four weeks.

About NKX101
NKX101, a wholly owned program of Nkarta, is a healthy donor-derived CAR-NK investigational therapy targeting NKG2D ligands on tumor cells. NKX101 is being investigated in an ongoing Phase 1 single-arm, multi-center, open label clinical trial that is designed to assess the safety and anti-tumor activity of NKX101 as a multi-dose, multi-cycle monotherapy in patients with relapsed/refractory acute myeloid leukemia and higher-risk myelodysplastic syndromes (MDS).

About NKX019
NKX019, a wholly owned program of Nkarta, is a healthy donor-derived CAR-NK investigational therapy targeting CD19. NKX019 is being investigated in an ongoing Phase 1 single-arm, multi-center, open label clinical trial that is designed to assess the safety and anti-tumor activity of NKX019 as a multi-dose, multi-cycle monotherapy in patients with relapsed/refractory B cell malignancies.