On October 20, 2021 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, Crinetics Pharmaceuticals, OCT 20, 2021, View Source [SID1234591583]). In addition, Crinetics 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 shares to be sold in the offering are to be sold by Crinetics. 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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Crinetics intends to use the net proceeds from the proposed offering to fund the development of paltusotine, CRN04894, CRN04777 and its other research and development programs, and for working capital and general corporate purposes.

SVB Leerink, Evercore ISI and Cantor Fitzgerald are acting as joint bookrunning managers for the offering.

The securities described above are being offered by Crinetics pursuant to a shelf registration statement that became automatically effective upon its filing with 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: SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 800-808-7525, ext. 6105 or by email at [email protected]; from: Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or from: Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, by telephone at 212-829-7122 or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

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

On October 20, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its third quarter 2021 financial results on Wednesday, November 3, 2021, before the open of the US financial markets (Press release, Clovis Oncology, OCT 20, 2021, View Source [SID1234591582]). Clovis’ senior management will host a conference call and live audio webcast at 8:30am ET to discuss the Company’s results in greater detail.

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The conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, and a replay of the webcast will be available for 30 days.

Dial-in numbers for the conference call are as follows: US participants 888.440.4615, International participants 646.960.0682, conference ID: 2259685.

On October 20, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its third quarter 2021 financial results on Wednesday, November 3, 2021 (Press release, BioCryst Pharmaceuticals, OCT 20, 2021, View Source [SID1234591580]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 2592545. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 2592545.

On October 20, 2021 BeyondSpring Pharmaceuticals (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported the presentation of preclinical data in patient-derived cancer models supporting the use of plinabulin in small cell lung cancer (SCLC) at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held October 7-10, 2021 (Press release, BeyondSpring Pharmaceuticals, OCT 20, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-announces-new-patient-derived-cancer-model-data-for-plinabulin-monotherpy-at-the-aacr-nci-eortc-virtual-international-conference-to-further-support-the-positive-clinical-d [SID1234591579]). Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which induces dendritic cell maturation for durable anti-cancer benefit, and selectively induces certain types of cancer cell apoptosis, both through immune defense protein GEF-H1 release and activation. This study demonstrates plinabulin’s direct single agent anti-cancer tumor effects in patient-derived models of SCLC and additional cancer types, including glioblastoma multiforme, bladder cancer, gastric cancer, sarcoma and triple-negative breast cancer.

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"The positive patient-derived (PDX) preclinical data increases our confidence in pursuing SCLC as an indication for plinabulin, which has shown high response rate data in human studies. This is supplemental to the maturation of dendritic cells in the cancer immune system and the induction of downstream mechanisms in specific cancer cell types," said Dr. Kenneth Lloyd, chief scientific officer of BeyondSpring. "The fact that plinabulin has already been associated with tumor responses in SCLC patients in a Phase 1 study presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting is a good indication that these patient-derived models are predictive. The preclinical data presented here supports our intended strategy for developing an option for cancer patients by combining plinabulin and checkpoint inhibitors in SCLC."

The study was intended to screen cancer cells for susceptibility to plinabulin. For this purpose, PDX models of cancer established from patient tumor biopsies were used in a manner that results in minimal chance for changes in cancer cell genetics, and hence, these models are considered more predictive of clinical response than common cancer models. Eighty PDX three-dimensional culture models were tested. Data showed that the cancer types most sensitive to plinabulin were:

SCLC (mean absolute IC70 = 35 nM; n = 7)
Bladder cancer (mean absolute IC70 = 38 nM; n = 9)
Soft tissue sarcoma (mean absolute IC70 = 57 nM; n = 10)
Dr. Lan Huang, BeyondSpring’s co-founder, CEO and chairwoman concluded, "We have been developing plinabulin in multiple cancer indications, based on the effects of plinabulin on dendritic cells and macrophages. Plinabulin’s anti-cancer effect is supported by the positive Phase 3 DUBLIN-3 non-small cell lung cancer study with evidence of the extension of overall survival. Plinabulin has also shown efficacy in preventing chemotherapy-induced neutropenia, which has received Breakthrough Designation and Priority Review from the U.S. FDA. Plinabulin’s single agent anti-cancer activity in PDX SCLC models and the relevant positive immuno-oncology combo preliminary clinical data in SCLC could potentially expand plinabulin’s cancer indications. We look forward to continuing to expand these anti-cancer indications in the clinic and to validate plinabulin as a ‘pipeline in a drug.’"

About Plinabulin

Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). It is being developed as a "pipeline in a drug" in multiple cancer indications.

On October 20, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported signing a mutual collaboration agreement (the "Agreement") with Ganesha Ecosphere Ltd. (BSE: GANECOS) (Ganesha), the largest recycled polyester (rPET) fiber producer in India with over 300-plus customers, 250-plus suppliers, and 500-plus product variants (Press release, Applied DNA Sciences, OCT 20, 2021, View Source [SID1234591578]). Under the terms of the Agreement, Ganesha will deploy the CertainT platform, Applied DNA’s traceability system, to tag an initial pilot production of recycled polyester (rPET) at Ganesha’s facilities in India and conduct confirmatory samples testing at Applied DNA’s laboratories in India and the U.S. The collaboration between the two companies will provide brands and textile manufacturers with a trusted solution to support their sustainability goals for rPET and confirm raw material authenticity at all stages of the textile value chain.

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The Agreement enables Ganesha to introduce and apply CertainT-verified rPET to provide assurance for the raw material with textile and apparel customers. Ganesha will also employ Applied DNA’s recently introduced SigNature T-100 tracer system that enables rPET source material to be quantified in polyester blends by the CertainT platform. SigNature T-100 is a proprietary molecular-based tracer system used to identify, analyze, and verify rPET, polypropylene, acrylic, and potentially other man-made materials for claims of both identification and quantification of the raw material tagged and subsequently spun into yarn for various textile products.

"Traceability has now added more authenticity and credibility to the entire textile supply chain and is becoming an integral part of the recycling process. With Applied DNA and CertainT, our customers can now trust in the original tagged synthetic fiber and verify product-related sustainability claims," stated Mr. B.P. Sultania, Joint President of Ganesha Ecosphere Ltd.

Since entering the rPET business in 1994, Ganesha has pioneered the manufacturing of rPET fiber and rPET yarn from post-consumer PET bottle scrap under the leadership and vision of Chairman Shri Shyam Sunder Sharmma. The company is the largest producer of rPET fiber, spun yarn, and dyed filament with a cumulative capacity of 118,800 metric tons per annum in India. Ganesha’s rPET products are components in the manufacture of textiles, such as T-shirts, body warmers, functional textiles such as non-woven air filter fabric, geo textiles, carpets, and car upholstery, and fillings for pillows, duvets, and toys.

"CertainT provides brands and manufacturers with a real strategic advantage that is truly sustainable, traceable and trusted. Our India and Asia-based support teams for recycled PET and other polymers facilitate CertainT’s commercial scale-up and integration into customers’ supply chain," stated Dr. James A. Hayward, president, and CEO of Applied DNA Sciences.