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Crinetics Announces Pricing of Common Stock Offering

On April 7, 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 the pricing of an underwritten public offering of 4,562,044 shares of its common stock at a price to the public of $16.44 per share (Press release, Crinetics Pharmaceuticals, APR 7, 2021, View Source [SID1234577682]). All of the shares to be sold in the offering are being sold by Crinetics. The gross proceeds to Crinetics from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $75.0 million. The offering is expected to close on or about April 12, 2021, subject to the satisfaction of customary closing conditions.

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Crinetics intends to use the net proceeds from the proposed offering to fund the development of paltusotine and its other research and development programs, and for working capital and general corporate purposes.

SVB Leerink is acting as sole bookrunning manager for the offering.

The securities described above are being offered by Crinetics pursuant to a shelf registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement relating to this offering will be filed with the SEC. The offering may be made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 800-808-7525, ext. 6105 or by email at [email protected]. Electronic copies of the final 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.

March 18, 20219 – Cancer Advances, Inc. Announces Abstract at AACR

On April 7, 2021 Cancer Advances, Inc., a clinical stage biopharmaceutical company developing therapeutics for gastrointestinal cancers, reported that an abstract will be included in the upcoming 2021 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held virtually from April 10-15, 2021 (Press release, Cancer Advances, APR 7, 2021, View Source [SID1234577681]).

The abstract is entitled, "Vaccination with Polyclonal Antibody Stimulator (PAS) prevents pancreatic carcinogenesis in the KRAS mouse model" and is available at the AACR (Free AACR Whitepaper) meeting website at View Source!/9325/presentation/1168.

PAS is a cancer vaccine that induces antibodies to gastrin, a known stimulator of certain pancreatic cancers. Using a KRAS mouse model, the researchers measured the impact of PAS vaccine on pancreatic PanIN lesions, inflammation, and fibrosis. Compared to a control group, the PAS vaccine slowed progression of PanIN lesions and rendered the tumor microenvironment less carcinogenic.

Details of the abstract are below:

Abstract Title: Vaccination with Polyclonal Antibody Stimulator (PAS) prevents pancreatic carcinogenesis in the KRAS mouse model

Abstract Number: 109

Date: April 10-15, 2021

BeiGene Announces First Commercial Manufacturing Approval for Its State-of-the-Art Biologics Facility in Guangzhou, China

On April 7, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported approval from the China National Medical Products Administration (NMPA) for BeiGene to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its state-of-the-art biologics facility in Guangzhou, China (Press release, BeiGene, APR 7, 2021, https://ir.beigene.com/news-releases/news-release-details/beigene-announces-first-commercial-manufacturing-approval-its [SID1234577680]). At over one million square feet (100,000 square meters) and 8,000 liters of biologics capacity approved for commercial supply, this wholly owned facility will immediately begin production of commercial supply of tislelizumab for the China market. An additional phase of construction currently in progress to bring total capacity to 64,000 liters is expected to be completed by the end of 2022.

"We started building this large-scale, commercial biologics manufacturing facility in 2017 to meet our expected future demand. Since that time, tislelizumab has been approved in several indications in China, included in the National Reimbursement Drug List (NRDL), and licensed to Novartis in Europe, North America, and Japan," commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene. "With significantly expanded capacity for tislelizumab and for other biologics in our pipeline, we are continuing our strong commitment to the quality, safety, and compliance of our products."

BeiGene’s Guangzhou manufacturing facility has been designed to operate in compliance with current Good Manufacturing Practice (cGMP) standards adopted by the U.S. Food & Drug Administration (FDA), the China National Medical Products Administration (NMPA), and the European Medicines Agency (EMA). The Guangzhou site is expected to be the first paperless biological manufacturing facility in China and integrates new technologies such as 3D modeling, digital twin, augmented interfaces, and artificial intelligence to improve quality and efficiency.

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three supplemental Biologics License Applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, for the second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 13 Phase 3 trials and three pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.

Arch Oncology Appoints Laurence Blumberg, M.D. President and CEO

On April 7, 2021 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, reported the appointment of Laurence Blumberg, M.D. as President and Chief Executive Officer and Board Member (Press release, Arch Oncology, APR 7, 2021, View Source;utm_medium=rss&utm_campaign=arch-oncology-appoints-laurence-blumberg-president-and-ceo [SID1234577679]). Dr. Blumberg has over thirty years of biotechnology industry experience leading companies as an executive, founder, analyst, and board member.

"On behalf of the Board, I welcome Laur to Arch Oncology as he brings extensive industry experience to lead the Company’s plans for AO-176, a novel anti-CD47 therapy for patients with cancer," said John McKearn, Ph.D., Managing Director, RiverVest Venture Partners and Chairman of the Board of Arch Oncology. "AO-176 has a differentiated and potentially best-in-class profile among anti-CD47 biologic therapies and we look forward to Laur leading the team’s progress as they work to deliver this novel therapy to patients."

Dr. Blumberg, added, "I am excited to join this team to build on the important work underway. With the ongoing clinical trials for AO-176 in patients with solid tumors and hematologic malignancies, I look forward to reaching multiple upcoming milestones, including the first reported clinical data mid-year 2021. This is an exciting moment in our Company’s evolution as we continue our mission on behalf of patients with cancer who need better therapeutic options."

He received a B.A. from Brandeis University, an M.D. from Temple University School of Medicine, and an Executive MBA from Columbia University School of Business. He completed an Internship in Surgery at Abington Memorial Hospital and was an Otolaryngology resident at Geisinger Medical Center prior to his biotechnology career.

Chinook Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results

On April 7, 2021 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, reported financial results for the full year ended December 31, 2020 (Press release, Aduro Biotech, APR 7, 2021, View Source [SID1234577678]).

"We are executing well on our goal of building Chinook into a leading kidney disease company. 2020 was a very busy and productive year, as we in-licensed atrasentan from AbbVie, closed a $115 million financing, brought BION-1301 into our pipeline through the merger with Aduro, unveiled CHK-336, our first internally-developed program, and bolstered our precision medicine discovery and research efforts," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "We are excited to have recently initiated our atrasentan phase 3 ALIGN and phase 2 AFFINITY trials and announced our collaboration with Evotec. We look forward to multiple data announcements from our BION-1301 program this year, as well as continuing to move CHK-336 towards the clinic."

Mr. Dobmeier continued, "Our team has grown over 300 percent since the beginning of 2020, and we’re continuing to execute on our hiring plans to ensure we have strong resourcing in place to advance our pipeline. Our solid cash position, which we expect to fund our operations to the middle of 2023, enables us to achieve key milestones across our programs."

2020 and Recent Accomplishments

Atrasentan

Enrolled the first patient in the phase 2 AFFINITY basket trial of atrasentan, a highly potent and selective endothelin A receptor (ETA) antagonist (see www.clinicaltrials.gov, identifier NCT04573920). Chinook expects to report data from initial patient cohorts of this study in 2022.

Enrolled the first patient with IgA nephropathy in the phase 3 ALIGN trial of atrasentan, (see www.clinicaltrials.gov, identifier NCT04573478). Chinook expects to report top-line proteinuria data from this study in 2023, which could support accelerated approval from the FDA.

Delivered an oral presentation at the 3rd Annual Chronic Kidney Disease Drug Development (CKD3) Summit on selective ETA receptor antagonist atrasentan for the treatment of primary glomerular diseases.

Entered into a license agreement with Morehouse School of Medicine for patents supporting the development of therapies in kidney diseases that disproportionately affect people of West African descent and underserved communities, including focal segmental glomerulosclerosis (FSGS) and HIV-associated nephropathy (HIVAN).

Delivered a poster presentation at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined on the phase 3 ALIGN trial design for atrasentan.

Entered into a license agreement with AbbVie for worldwide, exclusive rights to atrasentan.
BION-1301

Completed enrollment and analysis of a phase 1 intravenous (IV) to subcutaneous (SC) bioavailability study of BION-1301, a novel anti-APRIL monoclonal antibody, in healthy volunteers.

Dosed the first patient with IgAN in Part 3 of the ongoing phase 1 study of BION-1301.

Delivered a poster presentation at the 57th ERA-EDTA Virtual Congress and ASN Kidney Week 2020 Reimagined on healthy volunteer data from Part 1 (single ascending dose) and Part 2 (multiple ascending dose) of the ongoing phase 1 study of BION-1301.

Delivered a poster presentation at the 57th ERA-EDTA Virtual Congress on nonclinical toxicology studies of BION-1301 evaluating IV administration for up to six months and SC administration for up to one month.
CHK-336

Received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for CHK-336, an investigational oral small molecule inhibitor of lactate dehydrogenase A (LDHA), for primary hyperoxaluria (PH).

Delivered a preclinical poster presentation at the ASN Kidney Week 2020 Reimagined unveiling CHK-336 with the potential to treat all subtypes of PH and other disorders arising from excess oxalate.
Precision Medicine Research & Discovery

Participated in an expert panel discussion at the 3rd Annual CKD3 Summit on executing precision medicine in clinical trials.

Entered into a strategic collaboration with Evotec to discover and develop novel precision medicine therapies for polycystic kidney disease (PKD), lupus nephritis, IgAN and other primary glomerular diseases by leveraging the National Unified Renal Translational Research Enterprise (NURTuRE) patient biobank and Evotec’s proprietary PanHunter multi-omics platform.

Presented an oral abstract at the ASN Kidney Week 2020 Reimagined on a single cell transcriptomic atlas of human autosomal dominant polycystic kidney disease (ADPKD) through Chinook’s academic collaboration with the laboratory of Benjamin Humphreys, M.D., Ph.D., Joseph Friedman Professor of Renal Diseases in Medicine and Chief of Nephrology at Washington University School of Medicine in St. Louis.
Corporate

Appointed healthcare financial expert, Eric Bjerkholt, as chief financial officer.

Appointed the following life sciences industry veterans to the Board of Directors: William M. Greenman, president and chief executive officer of Cerus Corporation; Michelle Griffin, director and audit committee chair for Adaptive Biotechnologies, Acer Therapeutics and HTG Molecular Diagnostics, Inc.; Ross Haghighat, founder, chairman and managing partner of Triton Systems, Inc.; and Dolca Thomas, M.D., executive vice president, head of research and development and chief medical officer of Equillium, Inc.

Closed the merger with Aduro Biotech, Inc. on October 5, 2020 and began trading on the Nasdaq Global Select Market under the symbol "KDNY."

Completed a $115 million private placement financing with top-tier healthcare investors concurrent with the merger closing.
Anticipated Upcoming Catalysts

Chinook expects to present Gd-IgA1 biomarker data in healthy volunteers from Part 1 (single ascending dose) and Part 2 (multiple ascending dose) of the ongoing phase 1b study of BION-1301 at the ISN World Congress of Nephrology 2021 in April.

Chinook expects to present data from the BION-1301 phase 1 IV to SC bioavailability study in healthy volunteers at the ISN World Congress of Nephrology 2021 in April. Results from the study demonstrate the potential to transition to SC administration of BION-1301 in the long-term extension and phase 2 studies.

Part 3 of Chinook’s phase 1b study of BION-1301 is currently enrolling IgAN patients in an open-label setting, and Chinook expects to present a small subset of interim patient data in an oral presentation at the 58th ERA-EDTA Congress in June, as well as additional patient data at the ASN Kidney Week 2021 in November.

CHK-336 is currently in IND-enabling studies and advancing towards an expected IND submission in late 2021 or early 2022 for the treatment of primary hyperoxaluria.
Fourth Quarter and Full Year Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $250.4 million at December 31, 2020, compared to $11.2 million at December 31, 2019.

Revenue – Total revenue increased by $0.8 million for both the fourth quarter of 2020 and year ended December 31, 2020 as compared to the fourth quarter of 2019 and year ended December 31, 2019. The increase was due to revenue recognized related to research and development services provided under the collaboration agreement with Lilly.

Expenses –

Research and development expenses were $21.8 million for the fourth quarter of 2020 and $36.1 million for the year ended December 31, 2020, compared to $9.2 million and $17.0 million, respectively, for the same periods in 2019. For the quarter and year ended December 31, 2020, the increases were primarily due to external clinical and manufacturing expenses related to the atrasentan and BION-1301 clinical programs; higher personnel expenses, including salaries, benefits and stock-based compensation expense associated with hiring staff to build out our clinical and development capabilities; and increased spending for consulting and outside services. The year-over-year increase was partially offset by expenses in the prior year period for the in-license of atrasentan, the purchase of intellectual property and know-how from a related party to support the CHK-336 program and discovery research activities.

General and administrative expenses were $11.0 million for the fourth quarter of 2020 and $19.1 million for the year ended December 31, 2020, compared to $0.7 million and $3.0 million, respectively, for the same periods in 2019. For the quarter and year ended December 31, 2020, costs increased primarily due to legal, consulting and accounting costs related to the merger; an increase in personnel costs, including salaries, benefits and stock-based compensation expense due to the addition of administrative staff to buildout our public-company infrastructure; and an increase in facilities and other costs.

Net Loss – Net loss for the fourth quarter of 2020 was $49.9 million or $1.24 per share and $81.6 million or $6.20 per share for the year ended December 31, 2020, compared to net loss of $34.2 million or $14.65 per share and $46.5 million or $25.48 per share, respectively, for the same periods in 2019.

Cash Used in Operations – For the fourth quarter ended December 31, 2020, cash used in operations totaled $41.3 million, of which $20.1 million were non-recurring expenses related to the merger and integration with Aduro Biotech.