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Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Finch’s investigational new drug (IND) application for CP101. CP101 is the Company’s investigational orally administered microbiome therapeutic which is in late-stage clinical development for the prevention of recurrent C. difficile infection (CDI). The FDA lifted the clinical hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language.
“We are grateful that the FDA has completed its review of the information we provided, and we are pleased that the clinical hold on our CP101 IND has been lifted,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “We look forward to completing the additional activities that we believe will enable us to proceed with enrollment in PRISM4, our Phase 3 study of CP101 in recurrent C. difficile infection, and we thank our PRISM4 trial partners for their continued support and dedication to serving patients who are battling recurrent C. difficile infection.”
Finch expects to proceed with enrollment in PRISM4 after it completes certain manufacturing activities and quality system updates related to the recently resolved clinical hold, and submits for the FDA’s review and agreement the validation package for one of its release tests and a PRISM4 protocol amendment. The PRISM4 protocol amendment will implement changes to the algorithm used to diagnose suspected CDI recurrences and revisions to the planned statistical analysis. In parallel with these activities, Finch will continue to work with its PRISM4 trial sites to prepare for enrollment.
Finch plans to provide an update on the anticipated timing of both its PRISM4 trial and its planned AUSPIRE Phase 1b trial of FIN-211 in children with autism spectrum disorder and significant gastrointestinal symptoms when the Company reports its first quarter 2022 results.
About Finch Therapeutics
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs. With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for the prevention of recurrent C. difficile infection and has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. Finch is also developing FIN-211 for children with autism spectrum disorder and significant gastrointestinal symptoms. Finch has a partnership with Takeda focused on the development of targeted microbiome therapeutics for inflammatory bowel disease.
Human-First Discovery® is a registered trademark of Finch Therapeutics Group, Inc.
Forward-Looking Statements:
This press release includes “forward-looking statements”. Words such as “will,” “anticipates,” “believes,” “expects,” “intends,” “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding Finch’s ability to complete additional activities to enable it to proceed with enrollment in PRISM4, including completion of certain manufacturing activities and quality system updates and submission to the FDA’s satisfaction of a PRISM4 protocol amendment and the validation package for one of its release tests, its ability to continue working with PRISM4 trial sites to prepare for enrollment and its plans to provide an update on the timing of the PRISM4 trial and the AUSPIRE trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the risk that correspondence from the FDA may require Finch to collect additional data or information beyond what it currently expects; uncertainties relating to regulatory applications and related filing and approval timelines; Finch’s limited operating history and historical losses; the possibility that Finch may be delayed in initiating, enrolling or completing any clinical trials; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; the ability of Finch to comply with regulatory requirements or experience unanticipated problems with any of its product candidates; ongoing regulatory obligations and continued regulatory review may result in significant additional expense to Finch and Finch may be subject to penalties for failure to comply; Finch’s ability to maintain patent and other intellectual property protection and the possibility that Finch’s intellectual property rights may be infringed, invalid or unenforceable or will be threatened by third parties; Finch’s ability to qualify and scale its manufacturing capabilities to support multiple global clinical trials; Finch’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact and duration of the COVID-19 pandemic on Finch’s business. These and other risks are described more fully in Finch’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in Finch’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 31, 2022, as well as discussions of potential risks, uncertainties, and other important factors in Finch’s other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Finch undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact:
Stephen Jasper
Gilmartin Group
(858) 525-2047
stephen@gilmartinir.com
MARA webcast and conference call on Wednesday, May 4, 2022 at 4:30 p.m. EST. Financial results from Q1.
MARA has growing revenues 24/7. Every blockchain transaction is more revenue regardless of bitcoin price. Every day, hour , minute, and second Marathon generates revenues. > 1000's of miners running full bore @ MARA.
Possibly! Regardless, Musk may be spending time on new hires of engineers , administrators, and other personnel for Twitter.
Musk paying $1B+ taxes on his $4B sale.
EXPONENTIAL REVENUE GROWTH > $$$$$
RCMT
Up 45% @ closing bell > 17.07 >
RCMT > $weet! > $$$$$
RCM Technologies, Inc. is a provider of business and technology solutions through the deployment of engineering, specialty health care and information technology services. The Company operates through three segments: Engineering, Specialty Health Care and Information Technology Services. Its Engineering segment provides engineering and design services, technical writing and digital documentation across marine, locomotive, transportation and aerospace markets, and engineering, procurement and construction management (EPC), as well as demand side management/energy conservation services. The specialty health care segment provides staffing solutions of health care professionals, nurses, paraprofessionals, physicians and therapists and teletherapy services. The Information Technology (IT), segment provides enterprise business solutions, application services, infrastructure solutions, life sciences solutions and other vertical specific offerings.
RCM Technologies reported revenue of $82.0 million for the thirteen weeks ended April 2, 2022 (the current period), an 84.0% increase compared to $44.5 million for the thirteen weeks ended April 3, 2021 (the comparable prior-year period). Gross profit was $23.4 million for the current period, a 115.8% increase compared to $10.9 million for the comparable prior-year period. The Company experienced GAAP operating income of $9.0 million for the current period compared to $1.4 million for the comparable prior-year period. The Company experienced GAAP net income of $6.5 million, or $0.62 per diluted share, for the current period compared to $1.0 million, or $0.08 per diluted share, for the comparable prior-year period. The Company experienced adjusted EBITDA of $9.3 million for the current period compared to $1.8 million for the comparable prior-year period.
Bradley Vizi, Executive Chairman of RCM Technologies, commented, "RCM's first-quarter results demonstrated a good start to 2022. We continue to build on the strong foundation established and drive execution across our business units. We generated record profitability for the second-straight quarter, with adjusted EBITDA of $9.3 million, growing sequentially by 74% and 440% year-over-year. I want to thank the team for a job well done and their continued commitment to propelling RCM to the next level."
Over 100 employees worldwide. > Very low revenue production with huge corporate payroll, and multitude of operation expenses.
Trust Stamp Launches Biometric Multi-Factor Authentication Solution
8:00 am ET April 28, 2022 (Globe Newswire) Print
Trust Stamp (Nasdaq: IDAI, Euronext Growth: AIID ID), the Privacy-First Identity Company, announces the launch of its Biometric Multi-Factor Authentication (Biometric MFA) solution. The first-of-its-kind Biometric MFA streamlines robust identity assurance with a simple selfie. Built on Trust Stamp's advanced biometric tokenization, Biometric MFA is spoof-resistant, verifies liveness, and replaces or supplements vulnerable one-time passcodes ("OTP").
Learn more about the transformational Biometric MFA solution and become a Trust Stamp partner here.
Biometric MFA sits wherever OTP is currently deployed in an authentication process, providing a low-friction alternative that is more secure and privacy-positive. With one step, Biometric MFA adds a second and third authentication factor by testing liveness and irreversibly tokenizing data from a simple selfie, eliminating the need for passcodes from SMS, email, authenticator apps, or hardware tokens.
Trust Stamp's biometric authentication and data tokenization technologies have demonstrated success in enterprise implementations, with increased customer retention and reduced fraud losses. With established efficiency at scale, the unique Biometric MFA offering is at the cutting-edge of digital transformation. Forward-thinking organizations can now craft dynamic digital journeys that keep pace with global customer desires and needs, as well as the evolving fraud landscape.
"Device-based multi-factor authentication is vulnerable," says Kinny Chan, Trust Stamp's Chief Commercial Officer. "Passwords and passcodes aren't enough to ensure that genuine, authorized users are accessing their own accounts or initiating transactions. Biometric MFA lets partners layer intuitive, convenient, and seamless identity authentication where vulnerable passcodes are used today."
Trust Stamp's Identity Orchestration Platform streamlines delivery and implementation of the Company's technologies through a low-code approach. With applicability across the full identity lifecycle, including onboarding, KYC/AML, Biometric MFA, account recovery, fraud prevention, compliance, and more, the platform puts partners in a position to develop and deliver value-added solutions, create new business opportunities, and grow commercial potential with innovative, privacy-first services.
Enquiries
Trust Stamp Email: Shareholders@truststamp.ai
Gareth Genner, Chief Executive Officer
Nisha Naik, Executive VP of Communications
Davy (Euronext Growth Advisor) Tel: +353 1 679 6363
Barry Murphy
Investor Relations Tel: +1 212-671-1021
Crescendo Communications Email: idai@crescendo-ir.com
About Trust Stamp
Trust Stamp, the Privacy-First Identity Company, is a global provider of AI-powered identity services for use in multiple sectors including banking and finance, regulatory compliance, government, real estate, communications, and humanitarian services. Its technology empowers organizations with advanced biometric identity solutions that reduce fraud, protect personal data privacy, increase operational efficiency, and reach a broader base of users worldwide through its unique data transformation and comparison capabilities.
Located in seven countries across North America, Europe, Asia, and Africa, Trust Stamp trades on the Nasdaq Capital Market (Nasdaq: IDAI) and Euronext Growth in Dublin (Euronext Growth: AIID ID). Founded in 2016 by Gareth Genner and Andrew Gowasack, the company now employs over 100 people.
Safe Harbor Statement: Caution Concerning Forward-Looking Remarks
All statements in this release that are not based on historical fact are "forward-looking statements" including within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The information in this announcement may contain forward-looking statements and information related to, among other things, the company, its business plan and strategy, and its industry. These statements reflect management's current views with respect to future events-based information currently available and are subject to risks and uncertainties that could cause the company's actual results to differ materially from those contained in the forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. The company does not undertake any obligation to revise or update these forward-looking statements to reflect events or circumstances after such date or to reflect the occurrence of unanticipated events.
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https://ml.globenewswire.com/media/8e1f91a2-8441-4243-a9d0-6c8475770c59/small/trusts-png.png
comtex tracking
COMTEX_406381638/2010/2022-04-28T08:00:02
A Fast Track designation allows for more frequent meetings and written communication from the FDA to discuss a drug's development plan and the design of proposed clinical trials to ensure collection of appropriate data needed to support drug approval. Fast Track designation also allows FDA to conduct a rolling review of an NDA or BLA, which means that a drug company can submit completed sections of its application to FDA for review, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. A drug that receives Fast Track designation may also be eligible for Accelerated Approval and Priority Review.
SQZ Gets Fast-Track Designation for Tumor Treatment, Shares Rise 16%
5:21 pm ET April 27, 2022 (Dow Jones) Print
By Stephen Nakrosis
Shares of SQZ Biotechnologies Co. were trading higher in Wednesday's after-hours market following news the Food and Drug Administration gave fast-track designation for the company's lead cell therapy candidate, SQZ-PBMC-HPV.
SQZ-PBMC-HPV is being evaluated to treat HPV16+ advanced or metastatic solid tumors.
At 5:09 p.m. EDT, the company's stock had risen 16.97% to trade at $3.24 per share. The stock finished the day's regular session with a 5.14% loss, closing at $2.77 per share.
The FDA said fast track is a process "designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need."
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
April 27, 2022 17:21 ET (21:21 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
SQZ Biotechnologies Company is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies to benefit patients with cancer, autoimmune and infectious diseases, and other serious conditions. In oncology, it is developing cell therapy platforms that are based on directing tumor antigen-specific immune activation via engineered antigen presentation. It has three oncology candidates in clinical trials across its SQZ Antigen Presenting Cell (APC), SQZ enhanced APC (eAPC) and SQZ Activating Antigen Carrier (AAC), cell therapy platforms. In its autoimmune diseases portfolio, the Company is developing its SQZ Tolerizing Antigen Carrier (TAC), cell therapy platform to restore immune tolerance to self-antigens or other autoimmune disease-associated antigens that are central to disease pathogenesis. APC platform is focused on generating CD8+ T cell responses. SQZAPCs are created by ex vivo engineering of a patient's own peripheral blood mononuclear cells.
Statera Biopharma Shares Rise After Rights Deal With Immune Therapeutics
5:55 pm ET April 27, 2022 (Dow Jones) Print
By Stephen Nakrosis
Shares of Statera Biopharma Inc. were trading higher in Wednesday's after-hours market, following news the company entered a strategic agreement with Immune Therapeutics Inc. to sell rights to naltrexone and met-enkephalin.
At 5:46 p.m. ET, Statera shares were trading 52.3% higher at 31 cents each. Volume in the after-hours session topped 8.7 million shares.
The stock finished the day's regular session with a 1.23% loss, closing at just under 21 cents a share. The stock hit a 52-week low of fractionally above 20 cents a share earlier in the day.
Under the expected terms of the deal, Statera will receive an initial $2 million upfront payment and 5% of the issued and outstanding stock of Immune Therapeutics. Statera will also receive payments for, among other things, achievement of revenue-based milestones, new indications and royalties, in exchange for its rights to any product containing low-dose naltrexone as an active ingredient, the companies said.
In aggregate, the deal could generate over $400 million in non-dilutive payments to Statera, the company said.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
Up 146% @ 5.24
IDAI up 146% @ 5.30
Hycroft Mining S-1 Dilution Shows Registration For ~94.3M Share Common Stock Issuable Upon Exercise Of Warrants Via Selling Shareholders
TESLA CRASHES INTO JET > A Tesla appeared to crash into a private jet valued between $3 million and $3.5 million while in its self-driving Smart Summon mode on Friday, according to a witness.
A Reddit user with the username u/smiteme said they witnessed the event and posted a video of the incident to the platform.
The footage shows a driverless Tesla crashing into a Cirrus Vision Jet at Felt Fields Airport in Spokane, Washington. The airport did not immediately respond to Insider's request for comment made outside normal working hours.
Cirrus confirmed to Insider that the plane was a Cirrus Vision Jet priced between $3 million and $3.5 million and belonged to a customer, who it was unable to identify. It is unclear how much damage the car or plane sustained in the incident.
NKTX is a great $$$$$ opportunity.
He probably was Valedictorian @ Joe Biden School of Hard Knocks.
Man Accused of Stealing Ambulance in Chicago, Driving it 70 Miles During Police Chase in Custody
April 26, 2022
Ostin Technology Group Co., Ltd. (the "Company") (NASDAQ: OST), a supplier of display modules and polarizers in China, today announced the pricing of its initial public offering (the "Offering") of 3,375,000 ordinary shares (the "Ordinary Shares") at a public offering price of $4.00 per share for total gross proceeds of $13,500,000 before deducting underwriting discounts and offering expenses. The Offering is being conducted on a firm commitment basis. The Ordinary Shares have been approved for listing on The Nasdaq Capital Market and are expected to commence trading on April 27, 2022, under the ticker symbol "OST".
The Company has granted the underwriters an option, exercisable within 45 days from the closing date of the Offering, to purchase up to an additional 506,250 shares at the public offering price, less underwriting discounts and commissions, to cover over-allotment, if any.
Up 649 % @ 29.99 > China outfit!
Ostin Technology Group Co Ltd is a China-based holding company principally engaged in the manufacture and supply of display modules and polarizers. The Company is mainly engaged in the development and manufacture of thin film transistor liquid crystal display (TFT-LCD) modules of various sizes and custom sizes. Its products are mainly used in consumer electronics, outdoor LCD displays and automotive displays. Its customers include computer, automotive electronics and LCD display manufacturers. The Company primarily conducts its businesses in domestic and foreign markets.
I bought a few in the 8' s a couple hours ago.
BWV heading back to $60.00+ from its IPO launch in February. Waiting for some powerful news!!!!!
"The large seasonal burden of influenza warrants the development of improved vaccines,” said Joseph Hernandez, Chief Executive Officer of Blue Water Vaccines. “This data for H3N2 and influenza B epitopes supports our commitment to develop a vaccine that provides broad protection against all strains and eliminating the need for annual immunization. We are excited to continue our collaboration with The University of Oxford and move forward with this research supporting one of our lead vaccine candidates.”
The Wall Street tutes, Ivy League endowment funds, pension plans are accumulating shares daily .
NUTX
It was 40.00+ earlier this month. Moved up from OTC.
NUTX > Revenue is $783,000. per employee ( MarketWatch). Also, they're approximately 600 practicing MD's employed by NUTEX HEALTH INC.
NUTX
NUTX is a great $$$$$ opportunity.
NUTX > Revenue is $783,000. per employee ( MarketWatch). Also, there approximately 600 practicing MD's employed by NUTEX HEALTH INC.
Thanks pb!
Awesome revenues attracting investors. Looks like the OTC penny players have moved on.
Expenses excede revenues. Jet fuel is a very small entity . Ignore the pumps!
Ouch! mounting losses: -62.51%
Revenue (TTM)
102.71M
Gross Margin (TTM)
-31.13%
Net Margin (TTM)
-62.51%
Hycroft Mining Holding Corporation
HYMC:NASDAQ
EXPORTdownload chart
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RT Quote | Last NASDAQ LS, VOL From CTA | USD
after hours iconAfter Hours: Last | 03/25/22 EDT
1.56
quote price arrow up+0.28 (+21.87%)
Volume
111,025,862
Close
1.28
quote price arrow down-0.04 (-3.03%)
Volume
70,104,873
52 week range
0.28 - 5.00
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Date/Time 03/25 16:24
Close 1.2900
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NKTX running!
Not a p&d. Some folks need to learn how to read a corporate balance sheet / and SEC filings.
18.93 > > Looks like NKTX shelf placement is completed. Looks like another $200M in the kitty.