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NEWS
Direct Digital Holdings Reports Third Quarter 2023 Financial Results
Third Quarter 2023 Revenue Up 129% Year-Over-Year to $59.5 Million
Company Raises Full-Year 2023 Revenue Guidance to $170 Million - $190 Million
https://www.otcmarkets.com/stock/DRCT/news/story?e&id=2686812
NEWS
TRACON Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update
SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced financial results for the third quarter ended September 30, 2023. The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.
“We are on track to complete enrollment of 80 patients treated with single agent envafolimab in the ongoing pivotal ENVASARC trial this year. The data monitoring committee recommended the study continue as planned in September based on a review of 46 patients and since then more than 20 additional patients have enrolled. We expect to report updated response rate data before the end of the year, with final data anticipated mid-2024,” said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. “We also expect to license our Product Development Platform to one or more companies this year to allow them to transform their clinical operations.”
Recent Corporate Highlights
In September, we announced the ENVASARC Phase 2 pivotal trial more than exceeded the futility threshold at the second and final interim analysis and will proceed as planned. The objective response rate (ORR) in the initial 46 patients treated with single agent envafolimab was 13% by investigator review and 8.7% by blinded independent central review (BICR), all of which were confirmed responses. Envafolimab monotherapy was generally well tolerated and median duration of response by BICR was greater than six months. The primary endpoint of the study is achievement of an ORR in nine of 80 patients (11.25%) treated with envafolimab by BICR and median duration of response of greater than six months is a key secondary endpoint. Since the announcement, more than 20 additional patients have enrolled.
In July, we announced collection of the arbitration award of $22M from I-Mab Biopharma.
Expected Upcoming Milestones
Complete accrual of the ENVASARC pivotal trial in the fourth quarter of 2023 and release updated response rate data before the end of the year.
Continue to leverage TRACON’s cost-efficient, CRO-independent product development platform to generate non-dilutive capital by the end of the year.
Final data from ENVASARC pivotal trial in mid-2024.
Third Quarter 2023 Financial Results
Cash, cash equivalents and restricted cash were $7.8 million at September 30, 2023, compared to $17.5 million at December 31, 2022.
Research and development expenses for the third quarter of 2023 were $2.3 million, compared to $4.1 million for the third quarter of 2022. The decrease was primarily related to enrollment into only cohort C in the ongoing ENVASARC pivotal trial.
General and administrative expenses for the third quarter of 2023 were $1.3 million, compared to $2.3 million for the third quarter of 2022. The decrease was primarily attributable to lower legal expenses.
We received a refund of $2.0 million in arbitration success fees from our law firm in addition to the write off of approximately $0.3 million in legal fees in the third quarter of 2023.
We recorded other income of approximately $13.0 million in the third quarter of 2023 in conjunction with the collection of the arbitration award.
Net income for the third quarter of 2023 was $10.8 million, compared to a net loss of $6.4 million for the third quarter of 2022.
Conference Call Details
To access the call by phone, please register using this link and you will be provided with dial-in details.
A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.
After the live webcast, a replay will remain available on TRACON’s website for 60 days.
About Envafolimab
Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.
About ENVASARC (NCT04480502)
The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON is enrolling patients in ENVARSAC with UPS or MFS who have progressed following one or two lines of prior treatment and have
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Marpai, Inc. (CIK: 0001844392)
Withdrawal of Registration Statement on Form S-1, as amended (File No. 333-274162)
Ladies and Gentlemen:
Pursuant to Rule 477 under the Securities Act of 1933, as amended (the “Act”), Marpai, Inc. (the “Registrant”) hereby respectfully requests that the Securities and Exchange Commission (the “Commission”) consent to the withdrawal of the Registrant’s registration statement on Form S-1, as amended (File No. 333-274162) together with all amendments and exhibits thereto (the “Registration Statement”).
The Registrant is hereby requesting such withdrawal due to adverse market conditions for smaller companies.
The Registrant hereby confirms that no securities have been sold in connection with the offering contemplated by the Registration Statement.
Accordingly, the Registrant hereby respectfully requests that an order granting the withdrawal of the Registration Statement be issued by the Commission.
If you have any questions or comments regarding this request for withdrawal, please contact the Registrant’s counsel, Ron Ben-Bassat of Sullivan & Worcester LLP at 212-660-5003 or rbenbassat@sullivanlaw.com.
Sincerely,
/s/ Damien Lamendola
Damien Lamendola
Chief Executive Officer
BLINK CHARGING ANNOUNCES RECORD THIRD QUARTER WITH 152% REVENUE GROWTH TO $43.4 MILLION AND 167% INCREASE IN GROSS PROFIT
Download as PDFNovember 09, 2023 4:02pm EST
https://ir.blinkcharging.com/news-events/press-releases/detail/2488/blink-charging-announces-record-third-quarter-with-152
Did anyone grab the $2.53 dip?
INBS As of November 3, 2023, there were 8,734,381 shares of the registrant’s Common Stock issued and outstanding.
INSANITY
INBS As of November 3, 2023, there were 8,734,381 shares of the registrant’s Common Stock issued and outstanding.
INSANITY
CareDx Reports Third Quarter 2023 Results
BRISBANE, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers — today reported financial results for the third quarter ended September 30, 2023.
Third Quarter 2023 Highlights
Reported revenue of $67.2 million, an increase of 7% over the second quarter of 2023, excluding approximately $7.8 million related to Medicare claims billing that were held over from the first quarter of 2023 and recognized in second quarter 2023 revenue.
Grew Testing Services patient results to 38,400, an increase of 2% compared to the second quarter of 2023.
Achieved revenue of $9.9 million for Digital Solutions and $9.5 million for Products, representing year-over-year growth of 33% for both businesses.
Achieved the fourth consecutive quarter of collections at over 100% of revenue for Testing Services; collected over $22 million in incremental cash in the past four quarters.
Maintained a strong balance sheet, with $268.2 million in cash and cash equivalents, and marketable securities, with no debt.
Received Medicare coverage for HeartCare™ and AlloSure® Lung.
Raised revenue guidance to $274 to $278 million for the full year 2023.
SEC has concluded its inquiry and does not intend to recommend an enforcement action against the Company.
“CareDx continues to be well-placed in the transplant market. We are pleased to see a baseline being set in the Testing Services business in Q3 as patient testing volumes appear to have stabilized,” said Alex Johnson, President of Patient and Testing Services, and member of the Office of the CEO at CareDx. “We remain committed to bringing high impact innovation to the transplant clinic, while accelerating our path back to profitability.”
Third Quarter 2023 Financial Results
Revenue for the three months ended September 30, 2023, was $67.2 million, a decrease of 15% compared with $79.4 million in the third quarter of 2022, and an increase of 7% compared with $62.5 million in the second quarter of 2023, excluding approximately $7.8 million related to Medicare claims billing that were held over from the first quarter of 2023 and recognized in second quarter 2023 revenue. Testing services revenue for the quarter was $47.8 million, compared with $64.8 million in the same period in 2022.
Approximately 38,400 AlloSure® and AlloMap® patient results were provided in the quarter, representing a decrease of 18% as compared to the same quarter a year ago, and an increase of 2% compared to the second quarter of 2023.
For the third quarter of 2023, net loss was $23.5 million, compared to a net loss of $16.9 million in the same period of 2022. Basic and diluted net loss per share in the third quarter of 2023 was $0.43, compared to basic and diluted net loss per share of $0.32 in the third quarter of 2022.
Non-GAAP net loss was $9.6 million in the third quarter of 2023, compared to a non-GAAP net loss of $3.4 million in the third quarter of 2022. Basic and diluted non-GAAP net loss per share was $0.18 in the third quarter of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.06 in the third quarter of 2022.
Adjusted EBITDA for the third quarter of 2023 was a loss of $10.9 million, compared to an adjusted EBITDA loss of $2.5 million in the third quarter of 2022.
Cash and cash equivalents and marketable securities were $268.2 million as of September 30, 2023.
2023 Guidance
For the full year 2023, CareDx expects revenue to be in the range of $274 to $278 million.
About CareDx – The Transplant Company™
CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.
Forward-Looking Statements
This press release includes forward-looking statements, including statements regarding CareDx’s 2023 revenue expectations and the company’s path towards growth. All statements other than statements of historical fact contained in this press release, including statements regarding the future financial position of CareDx, including financial expectations, business strategy and plans and objectives for future operations, are forward-looking statements.
NEWS
Astra Announces Closing of Additional Debt Financing and Waiver of Previously Announced Defaults
Financing provided by affiliates of two early investors in Astra
ALAMEDA, Calif.--(BUSINESS WIRE)-- Astra Space, Inc. (“Astra”)(Nasdaq: ASTR) announced today that it has closed an initial financing with JMCM Holdings LLC (“JMCM”) and Sherpa Venture Funds II, LLP (together with JMCM, the “Investors”), affiliates of two early investors in Astra, for a total investment amount of approximately $13.4 million (the “Initial Financing”) pursuant to a reaffirmation agreement and omnibus amendment agreement dated November 6, 2023 (the “Initial Financing Agreement”). This Initial Financing is connected to Astra’s announcement in a report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on October 23, 2023 of the execution of a non-binding term sheet (the “Term Sheet”). The Term Sheet contemplates a financing of at least $15.0 million, from the Investors and other potential investors, and up to $25.0 million (the “Proposed Financing”).
The Initial Financing includes (1) a purchase by the Investors of the remaining $8.0 million aggregate principal amount of senior secured notes (the “Existing Notes”) and associated warrants (the “Existing Warrants”) to purchase up to 1.5 million post-reverse stock split shares of Astra’s Class A common stock, par value $0.0001 per share (the “Class A Common Stock”) issued on August 4, 2023 from the Astra’s senior secured creditor, pursuant to which Astra was in default under as of October 30, 2023, (2) a loan by the Investors to Astra and its subsidiaries in the aggregate principal amount of approximately $3.05 million evidenced by senior secured bridge notes (the “Bridge Notes”) that will come due on November 17, 2023, that will rank equally as to payment and lien priority with the Existing Notes that will be secured by the same collateral as the Existing Note and that will be guaranteed by all of the subsidiaries of Astra, and (3) a sale to the Investors of warrants (the “Warrants”) to purchase up to 5,314,201 shares of Astra’s Class A Common Stock at a purchase price of $0.125 per Warrant for an aggregate purchase price of approximately $664,275 that are immediately exercisable at an exercise price of $0.808 per share of Class A Common Stock, subject to certain adjustments and that expire on August 4, 2028.
Pursuant to the Initial Financing Agreement, the Investors have agreed to waive certain existing and prospective defaults and events of default under the Existing Notes, including the events of default under the Existing Notes described in the Astra’s Form 8-K filed with the SEC on November 3, 2023, and the requirement for Astra to comply with the minimum liquidity financial covenant in the Existing Notes until November 17, 2023 to provide Astra with time to raise additional liquidity through various capital raising and cost cutting initiatives and strategic transactions (the “Strategic Plan”).
Astra is in continuing discussions concerning the Proposed Financing with the Investors. The funding contemplated by the Term Sheet is conditioned upon execution of final definitive documentation among the Company and the Investors; however there can be no assurance that the Company and the Investors will be able to negotiate definitive documentation on the terms specified in the Term Sheet or to consummate the Proposed Financing at all.
The Bridge Notes and the warrants have not been and will not be, and any securities issued in connection with the Proposed Financing will not be, registered under the Securities Act of 1933, as amended (the “Securities Act”) or the securities laws of any other jurisdiction. The Bridge Notes, the Warrants and any securities issued in connection with the Proposed Financing may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. This press release does not constitute an offer to sell any security, including the Bridge Notes, the Warrants or any securities that may be issued in the Proposed Financing, nor a solicitation for an offer to purchase any security, including the Bridge Notes, the Warrants or any securities that may be issued in the Proposed Financing, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration, qualification, or exemption under the securities laws of any such jurisdiction.
About Astra Space, Inc.
Astra’s mission is to improve life on Earth from space by creating a healthier and more connected planet. Today, Astra offers one of the lowest cost-per-launch dedicated orbital launch services, and one of the industry’s leading flight-proven electric propulsion systems for satellites, Astra Spacecraft Engine. Visit astra.com to learn more about Astra.
Safe Harbor
The statements made herein concerning the Initial Financing and the Proposed Financing include “forward-looking statements.” Specific forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and can be identified by the use of, without limitation, words such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “targets,” “forecasts,” “seeks,” “would,” “could” or the negative of such terms or other variations on such terms or comparable terminology. Similarly, statements that describe any objectives, the Strategic Plan, the Proposed Financing, involvement of the Investors in the Proposed Financing, plans or goals are forward-looking. The forward-looking statements are based on the Company’s current intent, belief, expectations, estimates and projections regarding the Company, the Strategic Plan and the Proposed Financing. These statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to differ materially. Accordingly, readers should not rely upon forward-looking statements as a prediction of actual results and actual results may vary materially from what is expressed in or indicated by the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained herein.
https://cts.businesswire.com/ct/CT?id=bwnews&sty=20231106646305r1&sid=acqr8&distro=nx&lang=en
View source version on businesswire.com: https://www.businesswire.com/news/home/20231106646305/en/
Investor Contact:
investors@astra.com
Media Contact:
ZyVersa Therapeutics Announces Article Published in Peer-Reviewed Biomedical Journal Demonstrating That NLRP3 Inflammasome Inhibition Attenuates Inflammatory Bowel Disease Symptoms in Animal Model
Inflammatory bowel disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract affecting 1 in 100 Americans (around 2.4 million people) that can lead to disabling bowel symptoms and progressive bowel damage.
Study provides direct evidence that NLRP3 signaling is over-activated in IBD, and that its inhibition attenuates intestinal inflammation and tissue damage, leading to significant improvements in IBD symptoms, and restoration of normal intestinal microbial flora.
ZyVersa is developing Inflammasome ASC Inhibitor IC 100 which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation.
WESTON, Fla., Nov. 09, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed Biomedical Journal demonstrating that inhibiting NLRP3 inflammasomes in an IBD animal model attenuates intestinal inflammation and tissue damage, leading to significant improvements in IBD symptoms, and restoration of normal intestinal microbial flora.
In the paper titled, “Inhibition of NLRP3 attenuates sodium dextran sulfate-induced inflammatory bowel disease through gut microbiota regulation,” the authors evaluated human colon biopsy samples from patients with IBD and healthy controls, and conducted a study in an IBD mouse model. Following are key findings reported in the paper:
NLRP3 and IL-1ß expression is increased in the colon of IBD patients.
NLRP3 inhibition in the IBD animal model: Inhibited NLRP3 inflammasome signaling in the colon, resulting in significantly reduced levels of the pro-inflammatory cytokines IL-1b, IL-6, and TNF-a.Alleviated severe diarrhea and significantly improved IBD symptoms, based on the disease activity index score.Attenuated histopathological changes indicative of tissue damage (goblet cell reduction, crypt destruction, and epithelial barrier disruption).Restored gut microbiota to normal.
The authors stated, “In conclusion, this study provides direct evidence that NLRP3 signaling is over-activated in IBD patients. The inhibition of NLRP3 reverses the IBD-like symptoms in DSS-induced mice, which the regulatory effects on gut microbiota might mediate. Overall, this present study provides a basis for the clinical application of NLRP3 as a target for IBD treatment.” To read the article, Click Here.
“Restoration of quality of life is the ultimate long-term goal in IBD management. Although disease remission can often be achieved with current therapies, bothersome symptoms can still prevail,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “The research published in the Biomedical Journal provides support for inflammasome inhibition as a promising treatment option for IBD. ZyVersa is developing Inflammasome ASC inhibitor IC 100. Unlike NLRP3 inhibitors, designed to inhibit formation of one inflammasome to block initiation of the inflammatory cascade, IC 100 was designed to inhibit multiple types of inflammasomes and their associated ASC specks to uniquely block both initiation and perpetuation of damaging inflammation, which we believe is necessary to control chronic inflammation.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.
About Inflammasome ASC Inhibitor IC 100
IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1ß early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1ß and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product
NEWS
Intelligent Bio Solutions Inc. Reports Fiscal 2024 First Quarter Financial Results and Operational Highlights
https://www.otcmarkets.com/stock/INBS/news/story?e&id=2685090
Developing treatments for
conditions that cause pain.
On a mission to reduce the need for opioid prescriptions.
SWEET because $4.50 just ain't high enough! :)
Hey Kelly, yeah things are coming together. There will be a nice revenue producing Company to join HYSR and 2024 will be very nice for shareholders
$4.00 break! What a FREEGIN call by The Golden Cross! He always makes investors $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ KUDOS
Thanks so much for posting that link Kelly! :)
All aboard to PLUTO!!
$3.00 crossed!! YEA!
I agree. Mosty accumulation over the past 3 days! Huge triple digs gains over this period :)
Should cross $3.00 easy today imho
Very heavy pre-mkt buying!
$2.95 Pre - Mkt
Landmark Study Performed by the Independent McGuire Institute Confirms Positive 12 Month Clinical Outcomes for BIOLASE REPAIR® Perio Protocol
Validates BIOLASE REPAIR® Perio Protocol is a Superior Alternative as it pertains to patient reported outcomes.
LAKE FOREST, Calif., Nov. 8, 2023 /PRNewswire/ -- BIOLASE, Inc.(NASDAQ: BIOL), the global leader in dental lasers, today announced groundbreaking findings from a 12-month follow-up to a clinical trial performed at The McGuire Institute™. The findings will be published in the November 2023 issue of the Journal of Periodontology. The pioneering study was designed to meet the stringent American Association of Periodontology Best Evidence Consensus (BEC) standards, and is the first-of-its-kind study to compare BIOLASE's REPAIR® Perio protocol to the traditional minimally invasive surgical technique (MIST) treatment of moderate to severe generalized periodontitis.
Key highlights include:
Clinically Proven and Validated by Scientific ResearchThe study confirms that BIOLASE's Waterlase REPAIR® Perio protocol has similar and sustainable clinical outcomes as compared to traditional MIST in treating intrabony defects over the 12-month study thus reaffirming rigorous scientific research and the laser's clinical efficacy.
Enhanced Positive Patient ExperiencePatients who underwent BIOLASE's Waterlase REPAIR® Perio laser treatment reported significantly better patient-reported outcomes (PROs) at six months. These findings show that patients experienced less pain, reduced bleeding, and minimal discomfort, indicating a patient-friendly approach to periodontal care.
Safety and Minimal InvasivenessThe study found no adverse events associated with BIOLASE's Waterlase REPAIR® Perio laser procedure, highlighting its safety. Furthermore, it emphasizes that this laser treatment is minimally invasive, ensuring a highly effective and more comfortable experience for patients.
Faster RecoveryPatients in the BIOLASE Waterlase group reported a quicker reduction in swelling and discomfort, suggesting a faster and more comfortable recovery compared to traditional treatment.
"This exciting study provides further strong evidence that our Waterlase laser and REPAIR® Perio protocol is a safe and effective alternative to surgical treatment for intrabony periodontal defects with lasting results," said Dr. Russell Morrow, the Chief Dental Officer at BIOLASE. "The results ensure patients will not have to compromise on effectiveness, or comfort when choosing a less invasive approach."
BIOLASE's Waterlase laser is a minimally invasive laser that can be used to treat a variety of dental conditions, including intrabony periodontal defects. Intrabony periodontal defects are pockets that form between the tooth and bone and can lead to tooth loss. The Waterlase laser works by vaporizing the diseased tissue and stimulating the body to produce new bone and gum tissue.
"The study provides a firm rationale for an alternative surgical approach in the treatment of intrabony periodontal defects and forges the path for future comparisons using regenerative therapies in conjunction with the REPAIR® Perio technique," said Rick H. Heard, DDS, MS and Executive Director of Clinical Research and Operations of the McGuire Institute, a network of master clinicians trained and qualified to conduct high level clinical research in a practice based setting and located strategically throughout the United States. "It also supports superiority over a minimally invasive surgical technique with respect to patient reported outcomes."
Additionally, the McGuire study has earned a well-deserved nomination for the 2024 DrBicuspid Dental Excellence Awards, affectionately known as the "Cuspies," a platform to honor the best in dental innovation and excellence. Among the esteemed categories, the "Dental Study of the Year" spotlights research that promises to reshape the future of dental practice.
Winning this prestigious award at the Cuspies would not only be an accolade, but a testament to how the McGuire study could potentially redefine and elevate the standard of care for periodontal patients globally. It is an opportunity to celebrate a study with the power to reshape the landscape of periodontal treatment, setting new benchmarks for excellence in the dental field.
About BIOLASE
BIOLASE is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine. BIOLASE's products advance the practice of dentistry and medicine for patients and healthcare professionals. As of December 31, 2022, BIOLASE's proprietary laser products incorporate approximately 259 patented and 24 patent-pending technologies designed to provide biologically and clinically superior performance with less pain and faster recovery times. BIOLASE's innovative products provide cutting-edge technology at competitive prices to deliver superior results for dentists and patients. BIOLASE's principal products are dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications. From 1998 through December 31, 2022, BIOLASE has sold over 45,500 laser systems in over 80 countries around the world. Laser products under development address BIOLASE's core dental market and other adjacent medical and consumer applications.
For updates and information on Waterlase iPlus®, Waterlase Express™, and laser dentistry, find BIOLASE online at www.biolase.com, Facebook at www.facebook.com/biolase, Twitter at www.twitter.com/biolaseinc, Instagram at www.instagram.com/waterlase_laserdentistry, and LinkedIn at www.linkedin.com/company/biolase.
BIOLASE®, Waterlase® and Waterlase iPlus® are registered trademarks of BIOLASE, Inc.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995, that involve significant risks and uncertainties, including statements, regarding BIOLASE's expected revenue and revenue growth and beliefs regarding its financial resources. Forward-looking statements can be identified through the use of words such as "may," "might," "will," "intend," "should," "could," "can," "would," "continue," "expect," "believe," "anticipate," "estimate," "predict," "outlook," "potential," "plan," "seek," and similar expressions and variations or the negatives of these terms or other comparable terminology. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect BIOLASE's current expectations and speak only as of the date of this release. Actual results may differ materially from BIOLASE's current expectations depending upon a number of factors. These factors include, among others, the coronavirus (COVID-19) and the effects of the outbreak and actions taken in connection therewith, adverse changes in general economic and market conditions, competitive factors including but not limited to pricing pressures and new product introductions, uncertainty of customer acceptance of new product offerings and market changes, risks associated with managing the growth of the business, and those other risks and uncertainties that are described in the "Risk Factors" section of BIOLASE's most recent annual report filed on Form 10-K filed with the Securities and Exchange Commission. Except as required by law, BIOLASE does not undertake any responsibility to revise or update any forward-looking statements.
For further information, please contact:
Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for Third Quarter 2023
? Completed enrollment in the Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD); expect to report topline data in the fourth quarter of 2024 ?
? U.S. Food and Drug Administration (FDA) lifted clinical hold for pociredir (formerly FTX-6058) in sickle cell disease (SCD); trial reinitiation underway ?
? Cash runway extended into 2026 ?
? Conference call and webcast scheduled for 8:00 a.m. ET today ?
CAMBRIDGE, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (“Fulcrum”) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today reported financial results for the third quarter of 2023 and provided a business update.
“In the third quarter of 2023, we completed enrollment for the Phase 3 REACH trial of losmapimod and resolved the clinical hold for pociredir, bringing us one step closer to delivering on our mission to improve the lives of patients with rare genetic diseases,” said Alex C. Sapir, Fulcrum’s president and chief executive officer. “Building on this momentum, we remain focused on strong execution and believe we are now well-positioned to deliver on important clinical milestones, including topline data for REACH, which is expected in the fourth quarter of 2024. REACH is designed to demonstrate the potential of losmapimod to slow disease progression and address the debilitating effects of FSHD. We believe losmapimod could be the first approved treatment for this disease. With the clinical hold for pociredir lifted, we have been working diligently to resume enrollment in the Phase 1b trial for patients with SCD and look forward to building on the encouraging early clinical data observed to date. We remain very excited about pociredir’s potential to shift the current standard of care and importantly, offer a differentiated oral option.”
Recent Business Highlights
In September 2023, completed enrollment in REACH, a Phase 3 clinical trial evaluating losmapimod in patients with FSHD at sites in the United States, Canada, and Europe. The trial enrolled 260 patients. Fulcrum expects to report topline data in the fourth quarter of 2024. There are currently no approved treatments for FSHD.
In August 2023, the FDA lifted the clinical hold on the Investigational New Drug application for pociredir for the treatment of SCD. The Phase 1b trial will be re-initiated at the 12 mg once daily dose (Cohort 3), which is expected to enroll approximately 10 patients, followed by an additional cohort of 10 patients at the 20 mg once daily dose (Cohort 4). The protocol was amended to revise the inclusion and exclusion criteria to target patients with higher disease severity. To learn more about the amended protocol and planned Phase 1b trial of pociredir, please see the program update presentation on Fulcrum’s website.
Third Quarter 2023 Financial Results
Cash Position: As of September 30, 2023, cash, cash equivalents, and marketable securities were $257.1 million, as compared to $202.9 million as of December 31, 2022.
Collaboration Revenue: Collaboration revenue was $0.8 million for the third quarter of 2023 as compared to $1.2 million for the third quarter of 2022.
R&D Expenses: Research and development expenses were $18.2 million for the third quarter of 2023 as compared to $15.4 million for the third quarter of 2022. The increase of $2.8 million was primarily due to increased costs associated with the advancement of REACH, including the completion of enrollment during September 2023.
G&A Expenses: General and administrative expenses were $10.0 million for the third quarter of 2023 as compared to $9.7 million for the third quarter of 2022. The increase of $0.3 million was primarily due to increased facilities, professional services, and software costs.
Net Loss: Net loss was $24.0 million for the third quarter of 2023 as compared to $23.7 million for the third quarter of 2022.
Updated Cash Runway Guidance
Fulcrum now expects that its existing cash, cash equivalents, and marketable securities will be sufficient to fund its operating requirements into 2026, an update to previous guidance of mid-2025.
Conference Call and Webcast
Fulcrum Therapeutics, Inc. will host a conference call and webcast today at 8:00 a.m. ET to review the third quarter 2023 recent business highlights and financial results. Individuals may register for the conference call by clicking the link here. Once registered participants will receive dial-in details and a unique pin which will allow them to access the call. The webcast will be accessible through the Investor Relations section of Fulcrum’s website at www.fulcrumtx.com or by clicking here. Following the live webcast, an archived replay will also be available for 90 days.
About Fulcrum Therapeutics
Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s two lead programs in clinical development are losmapimod, a small molecule in development for the treatment of facioscapulohumeral muscular dystrophy (FSHD), and pociredir (formerly known as FTX-6058), a small molecule designed to increase expression of fetal hemoglobin and in development for the treatment of sickle cell disease (SCD) and other hemoglobinopathies. Fulcrum uses proprietary technology to identify drug targets that can modulate gene expression to treat the known root cause of gene mis-expression. For more information, visit www.fulcrumtx.com and follow us on Twitter@FulcrumTx and LinkedIn.
About Losmapimod
Losmapimod is a selective p38a/ß mitogen activated protein kinase (MAPK) inhibitor. Fulcrum exclusively in-licensed losmapimod from GSK following Fulcrum’s discovery of the role of p38a/ß inhibitors in the reduction of DUX4 expression and an extensive review of known compounds. Results reported from the Phase 2b ReDUX4 trial demonstrated slower disease progression and improved function, including positive impacts on upper extremity strength and functional measures supporting losmapimod’s potential to be a transformative therapy for the treatment of FSHD. Although losmapimod had never previously been explored in muscular dystrophies, it had been evaluated in more than 3,600 subjects in clinical trials across multiple other indications with no safety signals attributed to losmapimod. Losmapimod has been granted FDA Fast Track designation and Orphan Drug Designation for the treatment of FSHD. Losmapimod is currently being evaluated in a Phase 3 multi-center randomized, double-blind, placebo-controlled, 48-week parallel-group study in people with FSHD (NCT05397470).
About FSHD
FSHD is a serious, rare, progressive, and debilitating disease for which there are no approved treatments. It is characterized by fat infiltration of skeletal muscle leading to muscular atrophy involving primarily the face, scapula and shoulders, upper arms, and abdomen. Impact on patients includes relentless and accumulating muscle and functional loss impacting their ability to perform activities of daily living, loss of upper limb function, loss of mobility and independence, and chronic pain. FSHD is one of the most common forms of muscular dystrophy and has an estimated patient population of 16,000 to 38,000 in the United States alone.
About Pociredir
Pociredir is an investigational oral small-molecule inhibitor of Embryonic Ectoderm Development (EED) that was discovered using Fulcrum’s proprietary discovery technology. Inhibition of EED leads to potent downregulation of key fetal globin repressors, including BCL11A, thereby causing an increase in fetal hemoglobin (HbF). Pociredir is being developed for the treatment of SCD and other hemoglobinopathies. Initial data in SCD demonstrated proof-of-concept and achieved absolute levels of HbF increases associated with potential overall patient benefit. In clinical trials conducted prior to the clinical hold, pociredir was generally well-tolerated in people with SCD with up to three months of exposure, with no serious treatment-related adverse events reported. Pociredir has been granted U.S. Food and Drug Administration (FDA) Fast Track designation and Orphan Drug Designation for the treatment of SCD. To learn more about these trials please visit ClinicalTrials.gov.
About Sickle Cell Disease
Sickle cell disease (SCD) is a genetic disorder of the red blood cells caused by a mutation in the HBB gene. This gene encodes a protein that is a key component of hemoglobin, a protein complex whose function is to transport oxygen in the body. The result of the mutation is less efficient oxygen transport and the formation of red blood cells that have a sickle shape. These sickle shaped cells are much less flexible than healthy cells and can block blood vessels or rupture cells. People with SCD typically suffer from serious clinical consequences, which may include anemia, pain, infections, stroke, heart disease, pulmonary hypertension, kidney failure, liver disease, and reduced life expectancy.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, including express or implied statements regarding Fulcrum’s clinical trials, including timing of topline data for the Phase 3 REACH trial of losmapimod; reinitiation of the Phase 1b trial of pociredir; Fulcrum’s ability to deliver an FDA-approved therapy for FSHD patients; effects of the revised inclusion and exclusion criteria on Fulcrum’s Phase 1b trial of pociredir; the potential for pociredir to shift the standard of care; and Fulcrum’s cash runway; among others. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Fulcrum’s ability to continue to advance its product candidates in clinical trials; initiating and enrolling clinical trials on the timeline expected or at all; obtaining and maintaining necessary approvals from the FDA and other regulatory authorities; replicating in clinical trials positive results found in preclinical studies and/or earlier-stage clinical trials of losmapimod, pociredir and any other product candidates; obtaining, maintaining or protecting intellectual property rights related to its product candidates; managing expenses; managing executive and employee turnover, including integrating a new CEO and CFO; and raising the substantial additional capital needed to achieve its business objectives, among others. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Fulcrum’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties, and other important factors, in Fulcrum’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Fulcrum’s views as of the date hereof and should not be relied upon as representing Fulcrum’s views as of any date subsequent to the date hereof. Fulcrum anticipates that subsequent events and developments will cause Fulcrum’s views to change. However, while Fu
Really nice earnings update here = https://www.otcmarkets.com/stock/PRCH/news/story?e&id=2683010
Lumos Pharma Announces Topline Data from Phase 2 OraGrowtH210 and OraGrowtH212 Trials of LUM-201 in PGHD Met All Primary and Secondary Endpoints
Phase 2 Data Provide Supportive Evidence to Advance Oral LUM-201 to Phase 3
OraGrowtH210 Results Show LUM-201 Dose of 1.6 mg/kg Achieves Annualized Height Velocities (AHV) of 8.2 cm/yr at 6 Months and 8.0 cm/yr at 12 Months, Comparable to Growth Rates for Moderate PGHD Population
Delta at 6 and 12-month AHV Between Optimal LUM-201 Dose of 1.6 mg/kg and rhGH Comparator Arm is Within the Non-inferiority Margin (< 2 cm/yr) Suggested by FDA for Recent Approvals
Initial 24-month LUM-201 Data from Combined OraGrowtH210 and OraGrowtH212 Trials Demonstrate a Sustained AHV Effect from Year 1 to Year 2
Met Pre-specified Primary Endpoint of Validation of Predictive Enrichment Marker (PEM) Test and Secondary Endpoint Demonstrating 100% Reproducibility of PEM-Positive Classification
OraGrowtH212 Demonstrated That, with Only 20% the GH Concentration of Injectable rhGH, LUM-201 Achieved Expected AHV While Demonstrating the Unique Pulsatile Mechanism of Action of LUM-201††
No Safety Signal to Date for LUM-201
Company to Host Conference Call Tomorrow Morning at 8:30AM ET
AUSTIN, Texas, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO) today announced that topline results from its Phase 2 OraGrowtH210 dose-finding trial and its Phase 2 OraGrowtH212 Pharmacokinetic/Pharmacodynamic (PK/PD) trial met all primary and secondary endpoints. Data from the OraGrowtH210 Trial demonstrated annualized height velocity (AHV) on the 1.6 mg/kg dose of orally administered LUM-201 of 8.2 cm/yr at six months and 8.0 cm/yr at 12 months on treatment,* in line with historical data in moderate pediatric growth hormone deficiency (PGHD) patients and within the targeted 2 cm/yr margin of the comparator injectable recombinant growth hormone (rhGH) arm. Data also provided preliminary validation of the predictive enrichment marker (PEM) strategy, with prespecified primary and secondary outcomes met, de-risking our patient selection for our Phase 3 program. Data from the OraGrowtH212 Trial confirmed that LUM-201’s unique pulsatile mechanism produces an increase in growth rates while restoring growth hormone secretion and IGF-1 to within normal ranges †, with levels substantially below those produced by exogenous injectable rhGH.†† Additionally, data from a small subset of 10 subjects combined 1.6 and 3.2 mg/kg dosage of LUM-201 in both OraGrowtH210 and OraGrowtH212 trials demonstrated the sustained effectiveness of AHV up to 24 months. Furthermore, the safety profile for LUM-201 remained clean throughout both Phase 2 studies, with no safety concerns identified in either of our Phase 2 trials conducted thus far.
“Results from our OraGrowtH trials have provided us with clear proof of concept that oral LUM-201 has the potential to serve as a viable alternative to injectable therapies in moderately growth hormone deficient patients. Our data indicates that LUM-201 can enhance AHVs in line with established standards for moderate PGHD patients undergoing rhGH therapy, demonstrating a robust and durable response,” said Rick Hawkins, Chairman and CEO of Lumos Pharma. “We look forward to discussing these data and finalizing our plans for a Phase 3 pivotal trial with the FDA in our end of Phase 2 meeting anticipated in the first half of 2024.”
Renowned pediatric endocrinologist Dr. Ron Rosenfeld, who also serves as the Chairman of our Clinical and Scientific Advisory Board, provided insight on the data, stating, "These findings not only align with historical growth expectations on therapy but also underscore the distinct advantage of LUM-201's unique pulsatile mechanism. Demonstrating the ability to achieve expected growth with oral LUM-201 while exposing patients to only 20% of the growth hormone compared to daily rhGH injections is a significant scientific breakthrough that has the potential to revolutionize the approach to treating children with moderate growth hormone deficiency."
OraGrowtH210 Topline Results Highlights
The OraGrowtH210 trial met its primary objective, with 6-month AHV data of 8.2 cm/yr supporting the 1.6 mg/kg as the optimal dose for a Phase 3 clinical trial.* The 6-month and 12-month AHV on 1.6 mg/kg/day met expectations for growth and were within the targeted 2.0 cm/yr margin for non-inferiority against injectable rhGH cohort.
https://ml.globenewswire.com/Resource/Download/e14ed9b0-f190-41e0-8c43-236ed34b5ceb
ANCOVA Model Terms: treatment, Age at dose 1, Sex, Baseline HT SDS, Baseline BMI SDS, Baseline IGF-1 SDS, LUM-201 PEM, Baseline BA Delay, HT SDS-MPH SDS Bars represent Least Squares Mean (LSM), Error bars represent the Standard Error of LSM
Dosage at 1.6 mg/kg demonstrates highest LUM-201 AHV at six months and 12 months
1.7 cm/yr difference between 1.6 mg/kg LUM-201 dose and rhGH comparator arm at 12 months falls within historical non-inferiority Phase 3 margins
LUM-201 AHVs align with historical growth rates of rhGH in patient populations with similar characteristics.
12-month AHV data available for 50/81 subjects: Growth rates durable at 12 months
The mean AHVs at 6 months and 12 months observed in the 1.6 mg/kg dose LUM-201 arm were 8.2 cm/yr and 8.0 cm/yr, respectively. These AHVs were in line with the Company’s expectations for 8.3-8.6 cm/yr AHV observed after 12 months of rhGH treatment in a moderate PGHD patient population.1,2,3
The higher than anticipated AHV seen in this moderate PGHD population treated in the rhGH control arm of the OraGrowtH210 Trial was inconsistent with multiple historical trials which predicted growth in the 8.3-8.6 cm/yr range for moderate PGHD1-4. This distinctive growth pattern observed in the daily GH arm of this study is likely due to a higher dosage and the presence of outliers. We anticipate that in a larger, more statistically robust Phase 3 trial, the AHV associated with rhGH treatment will align more closely with historical values for the moderate patient population.
The OraGrowtH210 Trial met the prespecified percent responder enrichment providing preliminary validation of the PEM strategy. Additionally, we have achieved a 100% success rate in meeting the predetermined outcome for positive PEM specification classification reproducibility.
OraGrowtH212 Topline Results Highlights
The topline results from the OraGrowtH212 Trial reveal that LUM-201 achieved an expected AHV with only 20% of the growth hormone (GH) concentration observed using injectable rhGH. This outcome was achieved through LUM-201's natural pulsatile mechanism, promoting growth in moderate PGHD subjects that align with historical norms. Notably, LUM-201 raised circulating GH to levels closer to normal physiological ranges, whereas treatment with injectable rhGH has been shown to elevate GH levels to four to five times that of typical healthy children. Furthermore, it's important to highlight that during the first 12 months of LUM-201 treatment, no IGF-1 values exceeded 2 standard deviations from the mean.
Combined 24-Month Data from OraGrowtH210 and OraGrowtH212 Trials
Eighteen and 24-month growth data were available for 10 subjects from the OraGrowtH210 and OraGrowtH212 Trials who met AHV criteria per protocol at 12 months.
Combined data from the 1.6 mg/kg and 3.2 mg/kg cohorts of both trials demonstrate sustained AHVs from 12 to 24 months without a considerable decline in growth velocity compared to the previously reported ~20% decline in AHV on rhGH from 12 to 24 months observed in the Pfizer Phase 4 KIGS dataset.3
Safety & Tolerability Highlights
The topline results from both the OraGrowtH210 and OraGrowtH212 trials have shown a clean safety record, characterized by an absence of treatment-related Serious Adverse Events (SAEs), no instances of participants discontinuing treatment due to adverse events (AEs), and the absence of any significant safety concerns in various parameters such as laboratory values, adverse event data, or in electrocardiogram (ECG) readings.
† Zadik et al Horm Res 1992
†† Adapted from data in Albertsson-Wikland et al JCEM 1994; 24h exposures listed reflect absorbance/bioavailability of ~60% of the administered dose,
* For all OraGrowtH Trial AHV values, ANCOVA Model Terms: treatment, Age at dose 1, Sex, Baseline HT SDS, Baseline BMI SDS, Baseline IGF-1 SDS, LUM-201 PEM, Baseline BA Delay, for graphs HT SDS-MPH SDS Bars represent Least Squares Mean (LSM), Error bars represent the Standard Error of LSM
1 Blum et al JES 2021,
2 Lechuga-Sancho et al JPEM 2009,
3 Ranke et al JCEM 2010, 4 Bright et al JES 2021
Conference Call and Webcast Details
Date: November 8, 2023
Time: 8:30 AM ET
Dial-in: 1-877-407-9716 or 1-201-493-6779 (international)
Conference ID: 13742617
Or Dial-in registration (Available 15 minutes prior to scheduled start time): https://callme.viavid.com/viavid/?callme=true&passcode=13742617&h=true&info=company-email&r=true&B=6
Webcast link: https://viavid.webcasts.com/starthere.jsp?ei=1642841&tp_key=d9efda8a69
Slides are available on the Lumos Pharma website in the “Investors & Media” section under “Events and Presentations” link: https://investors.lumos-pharma.com/events-presentations.
A replay of the call will be available approximately two hours after the completion of the call and can be accessed by using the same numbers as above for two weeks following the call.
Virtual KOL Event Planned
The Company plans to host a virtual KOL Event on December 6th to discuss topline results from OraGrowtH210 and OraGrowtH212 trials in greater detail and provide updates on clinical and corporate strategy. Management will be joined by the following three esteemed thought leaders in the field of endocrinology:
Andrew Dauber, MD, Chief of Endocrinology at Children's National Medical Center, Washington, D.C.
Fernando Cassorla, MD, Chief of Pediatric Endocrinology at the Institute of Maternal and Child Research, University of Chile
Leslie A. Soyka, MD, Chief of Pediatric Endocrinology, UMass Memorial Medical Center; Associate Professor, UMass Chan Medical School, Worcester, MA
Access information regarding the KOL Event will be provided at a later date.
OraGrowtH210 Trial Design
The OraGrowtH210 Trial is a global, multi-site study that assesses the effects of orally administered LUM-201 at three different dose levels (0.8, 1.6, 3.2 mg/kg/day) in comparison to daily injections of recombinant human growth hormone (rhGH) at a dose of 34 µg/kg/day. This trial involves 82 participants diagnosed with moderate Pediatric Growth Hormone Deficiency (PGHD). To enrich the trial population with individuals likely to respond to LUM-201, specific PEM criteria were applied during the screening process. These criteria included having a baseline IGF-1 value above 30 ng/ml and achieving a peak growth hormone value of 5 ng/ml or higher after administering a single 0.8 mg/kg dose of LUM-201 to treatment-naïve PGHD patients. It is important to note that the primary purpose of this study was not to establish efficacy or demonstrate non-inferiority compared to daily GH treatment.
OraGrowtH212 Trial Design
The OraGrowtH212 Trial is a single-site, open-label study designed to assess the pharmacokinetic (PK) and pharmacodynamic (PD) impacts of oral LUM-201. This trial includes up to 24 individuals with no prior treatment for Pediatric Growth Hormone Deficiency (PGHD), who are administered LUM-201 at two different dosage levels, specifically 1.6 and 3.2 mg/kg/day. Every participant in the OraGrowtH212 Trial met the criteria for Patient PEM positivity, ensuring their potential responsiveness to LUM-201.
About Lumos Pharma
Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases. The Company was founded and is led by a management team with longstanding experience in rare disease drug development. Lumos Pharma’s lead therapeutic candidate, LUM-201, is a novel, oral growth hormone (GH) secretagogue, seeking to transform the ~$3.4B global GH market from injectable to oral therapy. LUM-201 is currently being evaluated in multiple Phase 2 clinical studies in Pediatric Growth Hormone Deficiency (PGHD) and has received Orphan Drug Designation in both the US and EU. For more information, please visit https://lumos-pharma.com/.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of Lumos Pharma, Inc. that involve substantial risks and uncertainties. All such statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. A law that, in part, gives us the opportunity to share our outlook for the future without fear of litigation if it turns out our predictions were not correct.
We are passionate about our business - including LUM-201 and the potential it may have to help patients in the clinic. This passion feeds our optimism that our efforts will be successful and bring about meaningful change for patients. Please keep in mind that actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make.
We have attempted to identify forward-looking statements by using words such as “projected,” "upcoming," "will," “would,” "plan," “intend,” "anticipate," "approximate," "expect," “potential,” “imminent,” and similar references to future periods or the negative of these terms. Not all forward-looking statements contain these identifying words. Examples of forward-looking statements include, among others, statements we make regarding our Phase 2 data providing supporting evidence to advance oral LUM-201 to Phase
Its already traded 10x's its outstanding hence the HAULTS! As of August 11, 2023, there were 11,776,213 shares of the registrant’s Common Stock, $0.00001 par value, issued and outstanding.
3rd push towards $3.00
Halted at $1.64 MM's might have to bring her higher to find sellers
2nd heavy run up!
She dips often only to come back up. I'm still looking for $3.00+
I know. Its a dog with fleas!
The stock market is now nothing more than a game of Craps. We go with what works right!
Nice Job Jess. I'm gonna use this 3rd halt to buy more smelling salts!
NICE RAYYLY ! $2.43
HALTED 2ndx $!.44 up 111% today
Halted on $1.16 but will open above $1.22 FANTASTIC CALL BRO!
Off to the races!!!
$1.00 break on the way!