Form 10-K

New Analysis of SOLOIST-WHF Results Demonstrates Sotagliflozin’s Significant Effect in Reducing the Risk of Hospital Readmissions for Heart Failure

Retrieved on: 
Sunday, November 6, 2022
Patient, American Heart Association, Annual report, Mortality, Protein, Gastrointestinal tract, Research, Type 2 diabetes, Growth, Heart failure, SGLT2, Death, GLOBE, Form 10-K, Chronic kidney disease, SGLT1, Intellectual property, Neuropathic pain, University, Nasdaq, Holocene, U.S. Securities and Exchange Commission, FACC, Metabolism, The New England Journal of Medicine, Disease, Security (finance), AHA, Gene, Kidney, School, NEJM, Caregiver, Pharmaceutical industry, Lexicon, Diabetes

Treatment with sotagliflozin demonstrated significant relative risk reductions of 46% to 52% for readmission for non-fatal heart failure events and for the composite of cardiovascular death and readmission for heart failure at 30 or 90 days following hospital discharge versus placebo.

Key Points: 
  • Treatment with sotagliflozin demonstrated significant relative risk reductions of 46% to 52% for readmission for non-fatal heart failure events and for the composite of cardiovascular death and readmission for heart failure at 30 or 90 days following hospital discharge versus placebo.
  • Heart failure is the number one cause of hospitalizations for Americans ages sixty-five years and older, with approximately one million hospitalizations for heart failure annually in the United States.
  • Heart failure cost burden is projected to reach nearly seventy billion dollars in the United States by the year 2030, with 80% of those total costs related to hospitalizations.
  • This analysis provides evidence that sotagliflozin has the potential to address all of these concerns if administered to patients prior to or at hospital discharge after experiencing an episode of worsening heart failure.

Intellia Presents Updated Interim Data from the Cardiomyopathy Arm of Ongoing Phase 1 Study of NTLA-2001, an Investigational CRISPR Therapy for the Treatment of Transthyretin (ATTR) Amyloidosis at the American Heart Association Scientific Sessions 2022

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Saturday, November 5, 2022
American Heart Association, Private Securities Litigation Reform Act, Form 10-K, Adult, Intellia Therapeutics, NYHA, Part Two, U.S. Securities and Exchange Commission, Clinical trial, TTR, NTLA, Form, CRISPR, Cardiomyopathy, SEC, Polyneuropathy, Heart failure, Protein, Regeneron Pharmaceuticals, GLOBE, Amyloid, Cas9, Familial amyloid polyneuropathy, Security (finance), Degenerative disease, Nerve Damage, Patient, Cancer, Nobel Prize, Human, Science, Heart, Cardiology, Amyloidosis, Physician, ATTR, Genome, Observation, AHA, Annual report, Therapy, III, Serum, Tissue, Safety, New York Heart Association Functional Classification, NASDAQ, Risk, Liver, Pharmaceutical industry, Vaccine

Results were presented in a Late-Breaking Science oral presentation at the American Heart Association (AHA) Scientific Sessions 2022, held November 5 7 in Chicago, Illinois.

Key Points: 
  • Results were presented in a Late-Breaking Science oral presentation at the American Heart Association (AHA) Scientific Sessions 2022, held November 5 7 in Chicago, Illinois.
  • The interim data from the dose-escalation portion of the Phase 1 study include 12 adult patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM) with New York Heart Association (NYHA) Class I III heart failure.
  • These data highlight NTLA-2001s potential as a one-time treatment to permanently inactivate the TTR gene and reduce the disease-causing protein in people with ATTR-CM.
  • We believe a single dose of NTLA-2001 has the potential to halt and potentially reverse this life-threatening disease.

New Analysis of SCORED Trial Demonstrates Sotagliflozin’s Effect on Reducing Albuminuria in Patients With Type 2 Diabetes and Chronic Kidney Disease

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Saturday, November 5, 2022
Patient, American Heart Association, Annual report, Protein, Research, Gastrointestinal tract, Type 2 diabetes, Growth, Committee, Society, SGLT2, Death, University, GLOBE, Form 10-K, Grey Literature International Steering Committee, Chronic kidney disease, SGLT1, Intellectual property, Heart failure, Department of Medicine – University of Pamplona, Neuropathic pain, Department, EGFR, Poster, Nasdaq, Albuminuria, ASN, U.S. Securities and Exchange Commission, Cardiovascular disease, Risk, Metabolism, The New England Journal of Medicine, Diabetes, Disease, Security (finance), AHA, Gene, Kidney, NEJM, Pharmaceutical industry, Lexicon

THE WOODLANDS, Texas, Nov. 05, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a new post hoc analysis of results from the SCORED Phase 3 outcomes trial of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, was presented at the American Society of Nephrology Kidney Week 2022 annual scientific meeting in Orlando, Florida.

Key Points: 
  • Sotagliflozin showed statistically significant reductions in UACR regardless of albuminuria status at baseline in the SCORED trial, said David Z.I.
  • D., Professor in the Department of Medicine at the University of Toronto, and a member of the Steering Committee for the SCORED trial.
  • The poster, Effect of sotagliflozin on albuminuria in patients with type 2 diabetes and chronic kidney disease, can be downloaded from the ASN website .
  • The presence of albuminuria in patients with or without diabetes is associated with an increased risk for adverse renal and cardiovascular outcomes.

FAT Brands Announces Proposed Public Offering of Class A Common Stock

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Friday, November 4, 2022
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Tasty) Brands Inc. (Nasdaq: FAT, FATBB, FATBP, FATBW) (FAT Brands or the Company), today announced that it intends to offer to sell shares of its Class A Common Stock in an underwritten public offering.

Key Points: 
  • Tasty) Brands Inc. (Nasdaq: FAT, FATBB, FATBP, FATBW) (FAT Brands or the Company), today announced that it intends to offer to sell shares of its Class A Common Stock in an underwritten public offering.
  • All of the shares of Class A Common Stock are to be sold by the Company.
  • The Company expects to grant the underwriters a 45-day option to purchase up to an additional 15% of the number of shares of Class A Common Stock sold in this offering to cover over-allotments, if any.
  • FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world.

Aehr Receives Over $4 Million in Orders for its FOX WaferPak™ Full Wafer Contactors to Support Production Test and Burn-in of Silicon Carbide Power Semiconductors for Electric Vehicles

Retrieved on: 
Friday, November 4, 2022
3D, Industry, GLOBE, Form 10-K, Memory, Logic, Electric Bond and Share Company v. Securities and Exchange Commission, 2D, Securities Exchange Act of 1934, Gallium nitride, Efficiency, AEHR, Carrier, ABTS, Silicon, CEO, Securities Act of 1933, Contactor, Forward-looking statement, Automotive industry, NASDAQ, Maritime Transportation Security Act of 2002, Percussion section, Mobility, FOX, Security (finance), Traction, Ceramic, Printed circuit board

These WaferPak Contactors are expected to ship by the end of Aehrs fiscal third quarter ending February 28, 2023.

Key Points: 
  • These WaferPak Contactors are expected to ship by the end of Aehrs fiscal third quarter ending February 28, 2023.
  • Aehr Test has developed and introduced several innovative products, including the ABTSTM and FOX-PTM families of test and burn-in systems and FOX WaferPakTM Aligner, FOX-XP WaferPak Contactor, FOX DiePak Carrier and FOX DiePak Loader.
  • The WaferPak contactor contains a unique full wafer probe card capable of testing wafers up to 300mm that enables IC manufacturers to perform test and burn-in of full wafers on Aehr Test FOX systems.
  • Aehr disclaims any obligation to update information contained in any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

Broadwind Appoints Sachin Shivaram to Board of Directors

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Friday, November 4, 2022
Economy, Internal Revenue Code section 409A, Company, University, 100,000, Literature, Growth, Board of directors, Board, McKinsey & Company, Industry, GLOBE, Form 10-K, History, Coronavirus, Yale Law School, Internal Revenue Code, Securities Exchange Act of 1934, Wind, Samuel, Son & Co., COVID-19, Steel, CEO, ArcelorMittal, Federation, U.S. Securities and Exchange Commission, Aluminium, Severstal, NASDAQ, Philosophy, Security (finance), Public expenditure, Harvard University, Solution, Management, Bank, CICERO

CICERO, Ill., Nov. 04, 2022 (GLOBE NEWSWIRE) -- Broadwind (NASDAQ: BWEN, or the Company), a diversified precision manufacturer of specialized components and solutions serving global markets, today announced the appointment of Mr. Sachin Shivaram to its Board of Directors, effective November 2, 2022.

Key Points: 
  • CICERO, Ill., Nov. 04, 2022 (GLOBE NEWSWIRE) -- Broadwind (NASDAQ: BWEN, or the Company), a diversified precision manufacturer of specialized components and solutions serving global markets, today announced the appointment of Mr. Sachin Shivaram to its Board of Directors, effective November 2, 2022.
  • Mr. Shivaram brings to Broadwind more than fourteen (14) years of strategic leadership experience within the precision manufacturing sector.
  • Mr. Shivaram also serves as a member of the Board of Directors of Lodge Cast Iron.
  • Previously, Mr. Shivaram served as President, Sierra Aluminum and Pressure Vessel Group, both divisions of Samuel, Son & Co.

Lexicon Pharmaceuticals to Host Third Quarter 2022 Financial Results Conference Call and Webcast on November 9, 2022

Retrieved on: 
Friday, November 4, 2022
Form 10-K, Metabolism, Annual report, Protein, Intellectual property, Disease, Diabetes, Neuropathic pain, Security (finance), U.S. Securities and Exchange Commission, Gene, Heart failure, Pharmaceutical industry, Lexicon

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

Key Points: 
  • An audio webcast will be available online at www.lexpharma.com/events , with a webcast replay accessible for 14 days after the call.
  • Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients lives.
  • Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease.
  • Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

IntelGenx to Report Third Quarter 2022 Financial Results on November 10, 2022 – Conference Call to Follow

Retrieved on: 
Thursday, November 3, 2022
Annual report, Company, Risk, Form 10-K, Investor, Securities Exchange Act of 1934, Patient, Securities Act of 1933, Physician, U.S. Securities and Exchange Commission, Drug Quality and Security Act, IP, R, Webcast

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

Key Points: 
  • IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
  • IntelGenxs superior film technologies, including VersaFilm, DisinteQ, VetaFilm and transdermal VevaDerm, allow for next generation pharmaceutical products that address unmet medical needs.
  • IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services.
  • This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties.

Generation Bio Reports Business Highlights and Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 3, 2022
Annual report, G&A, DNA, Research, Therapy, RES, Atlas, GLOBE, Form 10-K, José Eulalio Samayoa, D, Private Securities Litigation Reform Act, Generation, COVID-19, U.S. Securities and Exchange Commission, R, Atlas Venture, Liver, Security (finance), Vaccine

CAMBRIDGE, Mass., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq: GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, reported business highlights and third quarter 2022 financial results.

Key Points: 
  • CAMBRIDGE, Mass., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq: GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, reported business highlights and third quarter 2022 financial results.
  • Since co-founding Generation Bio in 2017, Dr. Samayoa has led strategy, corporate and portfolio development, most recently serving as senior vice president.
  • R&D Expenses:Research and development (R&D) expenses were$21.2millionfor the quarter ended September 30, 2022, compared to $22.0 million for the quarter ended September 30, 2021.
  • G&A Expenses:General and administrative (G&A) expenses were$11.5millionfor the quarter ended September 30, 2022, compared to $9.7 million for the quarter ended September 30, 2021.

PROCEPT BioRobotics Reports Third Quarter 2022 Financial Results and Increases 2022 Revenue Guidance

Retrieved on: 
Thursday, November 3, 2022
Man, Annual report, Company, BPH, Research, Growth, International, Investment, GAAP, GLOBE, Form 10-K, Webcast, EBITDA, COVID-19, Benign prostatic hyperplasia, Nasdaq, Tax, LUTS, Health, U.S. Securities and Exchange Commission, Forward-looking statement, Providence, Security (finance), Multi-system (rail), Depreciation, SEC, Achievement, Biorobotics, Patient, Prostate, Solution, Medical device, Video game, Pharmaceutical industry, Bookkeeping, Broadcasting, Risk management, Aquablation therapy

Revenue for the third quarter of 2022 was $20.3 million, an increase of 135% compared to the prior year period.

Key Points: 
  • Revenue for the third quarter of 2022 was $20.3 million, an increase of 135% compared to the prior year period.
  • The increase was primarily driven by U.S revenues, including both system sales to new hospital customers and increased handpiece revenue.
  • U.S. handpiece and consumable revenue for the quarter was $8.0 million, an increase of 267% compared to the prior year period.
  • Operating expenses in the third quarter of 2022 were $32.3 million, compared with $17.0 million in the prior year period.