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As of November 3, 2023, 4,423,683 shares of the registrant’s common stock, $0.0001 par value, were issued and outstanding.
CRB-701 (SYS6002) A Next Generation Nectin-4 Targeting Antibody Drug Conjugate Demonstrates Encouraging Safety and Efficacy in Patients with Nectin-4 Positive Tumors in First-In-Human Study Presented at ASCO-GU 2024
Q3W schedule of CRB-701 (SYS6002) demonstrates a 43% ORR and 71% DCR at predicted therapeutically relevant doses
All assessable nectin-4 positive study participants with mUC and cervical cancer treated at or above this dose demonstrated some level of disease control
No dose limiting toxicities (DLTs) have been observed to-date up to 3.6 mg/kg (cohort 6) with further escalation at 4.5 mg/kg ongoing
No cases of peripheral neuropathy or skin rash have been observed to date
Cohort 6 is the first cohort selected for dose expansion
NORWOOD, Mass., Jan. 26, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), today announced that data from the first-in-human clinical study of CRB-701 (SYS6002) is being presented as a poster by the Company’s development partner CSPC Pharmaceutical Group at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The Phase 1 dose escalation study is being conducted in China and is enrolling participants with metastatic urothelial cancer (mUC) as well as participants with other solid tumors prospectively confirmed to have nectin-4 positive tumors. The study opened for enrollment in January 2023 and data through December 2023 from the first eighteen participants reflective of the first six dose cohorts (0.2-3.6mg/kg) will be shared.
The poster is titled Phase 1 Dose Escalation of SYS6002(CRB-701), a Next Generation Nectin-4 Targeting Antibody Drug Conjugate by DingWei Ye, et al and is being presented today at the poster session between 11:30 am-1pm PST. The poster will also be available on the Corbus website at the start of the poster presentation.
Safety
CRB-701 was well-tolerated with the majority of adverse events being grade one or two and reversible.
No adverse events above grade three were observed.
There have been no dose discontinuations or reductions in the study to date. There has been a singular participant that experienced a temporary dose interruption.
The dose escalation is ongoing at cohort 7 (4.5 mg/kg).
No cases of drug-related peripheral neuropathy or skin rash have been reported to date.
PK
Single dose PK suggested that TAb, ADC and MMAE increase in an approximate dose proportional manner.
No obvious accumulation was observed on cycle 3, day 1.
When compared to the exposures achieved with enfortumab vedotin (EV) at 1.25 mg/kg Q1W x21 days, CRB-701 (SYS6002) consistently demonstrated lower free MMAE concentrations.
Efficacy
Dose level 5 (2.7 mg/kg) and above represents the predicted therapeutically relevant doses based on allometric scaling.
A mixed tumor population (n=7) receiving doses of 2.7 mg/kg or 3.6 mg/kg demonstrated an ORR of 43% (3 partial responses -2 unconfirmed and one non-responding participant with no-nectin-4 expression) and a disease control rate of 71%.
The longest observed response to date is 11 cycles (~10 months) and ongoing.
All nectin-4 positive mUC and cervical patients at doses ≥ 2.7 mg/kg that were assessable at the time of the December 2023 data-cut off demonstrated levels of disease control and represent the CRB-701 (SYS6002) responsive population to date.
Dr. Yuval Cohen Chief Executive Office of Corbus commented, “CRB-701 with its novel antibody and next generation linker technology, appears to have a differentiated PK profile compared to EV, with a current safety profile devoid of peripheral neuropathy and skin rash, both dose limiting toxicities for EV. This could translate into meaningful benefits for mUC patients and other nectin-4 positive solid tumors such as cervical cancer.”
In reviewing the emerging profile of CRB-701 with one of the preeminent experts in GU cancers, Dr Daniel P. Petrylak M.D., Professor of Medicine and Urology at Yale School of Medicine, Dr. Petrylak shared that “the clinical responses in nectin-4 positive mUC and cervical cancer patients are encouraging and the early clinical safety provides the first evidence that CRB-701 has clinical activity in multiple nectin-4 expressing tumors. This justifies further investigation into the safety and efficacy of this promising compound.”
Dr. Cohen concluded, “as the current clinical study continues to progress in China with our partner CSPC, we at Corbus are looking forward to commencing our clinical study in the US in Q1 2024 under an already open IND. We are grateful to CSPC for the work that has gone into conducting this ongoing study and to the clinicians and study participants."
Dose escalation and expansion are ongoing and additional data presentations are planned for later this year.
About CRB-701
CRB-701 (SYS6002) is a next-generation antibody-drug-conjugate (ADC) targeting nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The Nectin-4 ADC PADCEV® (enfortumab vedotin-ejfv) is approved for use in late metastatic urothelial cancer and recently received an expanded label under an accelerated approval from the Food and Drug Administration for use in combination with KEYTRUDA® for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFß expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's restructuring, trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives o
Not touching this.
And here it goes again up 100%
Just hit $1.00 = 400% gain
25 million dollars UPFRONT. Holy shit!
This one has a history of insane moves!
Inspire Veterinary Partners (NASDAQ: IVP): Empowering Veterinary Professionals Through Its Employee-Oriented Ownership Model
VIRGINIA BEACH, VA / ACCESSWIRE / January 25, 2024 / Inspire Veterinary Partners Inc. (NASDAQ:IVP) introduces a distinctive approach to veterinary practice ownership that is markedly different from traditional investment models. This approach, diverging from the top-down that uses short-term strategies typical in private equity, emphasizes engaged ownership and a commitment to the well-being of both pets and veterinary professionals.
https://www.accesswire.com/imagelibrary/fbc4db47-b78d-4dff-83c5-b412268601ad/828093/YkUCa6705t4p_ZWHX_6Tt0kjLEkteQuPrh7Z-61bBTrTC6M7eBRzJFW8xDcxGzkOjQ3OY-Fdty-GjxI14IoQ2kFR4uqRK0Fvf_GSTA2Q4eJtwZhe8L57H8ibWgEousUrWQrn_HtfCxvkNkrFmsLHfB0.jpg
Transitioning Ownership With Inspire
Inspire provides a unique pathway for veterinary practice owners considering a transition. Unlike the traditional top-down models, where changes are often dictated by far-removed executives, Inspire's process involves a collaborative approach to understanding and enhancing the unique qualities of a practice. This method respects the value of the hospital while empowering employees to engage in self-directed change, ensuring that veterinary practices remain integral parts of their communities and firmly in the hands of those most qualified to run their respective practices: the employees. The Inspire model is also designed around long-term benefits for team members and clients versus the shorter timeframes dictated by ownership structures within Private Equity owned practices.
Employee-Centric Ownership And Benefits
Inspire's model is built on employee and shareholder ownership, led by experienced veterinary professionals. This structure aims to facilitate significant employee input in decision-making and fosters a culture of resilience, trust and respect. Comprehensive pay, benefits and customizable compensation packages are emphasized right from the beginning of a partnership, aimed at meeting individual needs and aspirations while contributing to a more satisfied and motivated workforce. With equity offerings planned for a large portion of the IVP workforce, the company is decidedly different from other consolidators in the pet care space which typically do not offer ownership, or when offered, the equity is only available to a select few.
Empowerment And Community Engagement
The Inspire organization is equally committed to veterinary care as it is personal development and mentorship, empowering veterinary professionals to positively impact their communities. Inspire's philosophy extends beyond financial interests, offering a sense of ownership and pride in their work, partners and communities. The future of veterinary care with Inspire is envisioned as one where practices are more than businesses - they are vital community members providing high-quality care to pets and peace of mind to pet owners through a bottom-up employee-driven business model. With experienced veterinary professionals in every department at Inspire and veterinarians in many support and leadership functions, the company prides itself on ensuring decisions are made with the long-term interest of the workforce, veterinary industry and shareholders alike.
Joining Inspire Inspire Veterinary Partners
For potential sellers seeking an acquisition partner for their hospital, joining Inspire involves an in-depth and personalized process. Meetings with Business Development at IVP lead to further conversation and hospital visits with operations and medical leadership and culminate in a visit with CEO Kimball Carr. Each meeting includes discussions about compensation and community goals and the entire. The process aims to foster trust and collaboration from the start, encompassing in-person interactions and town hall Q&A sessions.
Redefining Veterinary Care In The Private Equity Era
By prioritizing employee ownership and involvement alongside comprehensive compensation and benefits packages, Inspire Veterinary Partners aims to align the interests of veterinary professionals, pet owners and their pets. This approach challenges the conventional norms of veterinary practice ownership and offers an alternative model focused on community engagement and personal development. While the long-term impacts of such a model in the broader veterinary industry are yet to be fully realized, Inspire's strategy presents a novel perspective for those considering the evolving landscape of veterinary healthcare.
Featured photo by Parker Coffman from Unsplash.
Contact:
Kevin McGrath
kevin@tradigitalir.com
SOURCE: Inspire Veterinary Partners, Inc.
View the original press release on accesswire.com
© Copyright 2024 ACCESSWIRE. All Rights Reserved.
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Just bought 4k more shares on the dip @ $1.47
Correct. All my reasons are posted on the thread. You can start with this = https://www.otcmarkets.com/filing/html?id=17187667&guid=S1d-kaJI9XDvJth
$MRAI loading zone on impatient investors !.42
The number of shares outstanding of the registrant’s Common Stock as of November 13, 2023 was 2,046,308 shares.
The Company previously disclosed that it intended to hold its Special Meeting of Shareholders (the “Special Meeting”) on January 25, 2024. The Company has determined to cancel the Special Meeting.
Very nice find! Thank you so much! ")
Totally agree with you! Buy and hold 4 long-term
Thanks! 14.77 is INSANITY! Hey, look what is going on with AFIB. No news since November. I used to trade that one in the past and banked several times
NOT A WORD! Do you know?
I can't believe this but seeing is believing
Other than that its having a pretty good day
It's amazing what a couple of keywords can do! Excellent IR work. I got out at $12 and we make a nice living on buying and selling these POS Companies! :)))))
$11.93 and halted again
Starting to get some love now.
Hey! its all about making $$$$ :)
Yeah, but well-written fluff. Took a position last night,not gonna hold it long
LOL. Looks fake but I'll take it, man! :)
LOL. Looks fake but I'll take it, man! :)
DARN!!!! :(
Anytime brother. Link is here = https://www.otcmarkets.com/filing/html?id=16904691&guid=rkd-kqbsRiTyDVh
SciSparc Ltd. Announces $20 Million Standby Equity Purchase Agreement
TEL AVIV, Israel, Jan. 24, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, today announced that it has entered into a standby equity purchase agreement (the “SEPA”) with YA II PN, Ltd. (“YA”), a fund managed by Yorkville Advisors Global, LP. Under the terms of SEPA, YA is committed to purchase up to $20 million of the Company’s ordinary shares over the next thirty-six-month period, subject to a beneficial ownership cap of 4.99% of the share capital of the Company. The purchase price of the ordinary shares will be at a 3% discount of the weighted average price of the Company's ordinary shares during the three consecutive trading day period commencing on the trading day of the delivery of an advance notice by the Company.
The Company will have the right in its sole discretion to sell shares to YA from time to time upon the issuance of an advance notice, which has no right to require the Company to sell any shares, following the effectiveness of a registration statement with the Securities and Exchange Commission registering the ordinary shares issuable pursuant to the SEPA and other customary closing conditions.
The Company intends to use the proceeds from the potential offering of the ordinary shares pursuant to the SEPA for working capital and other general corporate purposes.
The securities described herein have not been registered under the Securities Act of 1933, as amended, and may not be sold in the United States absent registration or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
About SciSparc Ltd. (Nasdaq: SPRC):
I got it off a filing = Details Date Shares Issue price AUD$ $
Balance January 1, 2023 1,331,279,665 41,636,762 27,592,288
Expiry of options
-
45,735 30,308
Cancelation of shares through small parcel buy back April 27, 2023 (4,602,972 ) $ 0.00 (30,702 ) (20,346 )
Balance June 30, 2023 1,326,676,69
MOB has a large amount of shares outstanding. I'm just watching.
Very interesting = “Israel’s Ministry of Defense has thoroughly tested our ICE Cybersecurity software solution and validated its robust capabilities. Mobilicom has already commenced shipping our ICE Suite software solution bundled with the SkyHopper Pro datalinks to be incorporated into small-sized reconnaissance drones. These drones are immediately being delivered for surveillance and intelligence gathering,” stated Mobilicom CEO and Founder Oren Elkayam.
Nxu Secures EV Charging Patents, Showcasing Innovation and Leadership in EV Charging Technology
Patents address Nxu’s differentiated EV charging ecosystem technology
MESA, Ariz., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Nxu, Inc., (NASDAQ: NXU) (“Nxu”, “the Company”), a domestic technology company creating innovative EV charging and energy storage solutions for the infrastructure we need to power our electrified future, has secured a patent showcasing a novel component found on Nxu’s differentiated NxuOne™ EV Charging Solutions. Patent US 11,813,949 B2 protects the design for a locking mechanism in the NxuOne™ charging handle. Nxu was issued a second patent, US 11,616,277 B2, protecting Nxu’s proprietary thermal management solution for electric vehicle batteries. Nxu’s patent portfolio continues to grow, demonstrating its dedication to protecting the intellectual property it intends to fully deploy toward solving America’s EV charging infrastructure challenges, making powerful, fast, consistent charging solutions a reality from vehicle to charger to energy storage and back.
“From battery technology, vehicles, and charging, Nxu continues to innovate, owning the technology development that brings long-term strategic value to our shareholders and our customers,” said Nxu Founder, Chairman and CEO Mark Hanchett.
NxuOne™ EV Charging Solutions enable powerful, standard-agnostic charging, giving all EV users exactly the power they need, when they need it. EV drivers can expect a consistent, reliable charging experience with NxuOne™ EV Charging Solutions. Nxu previously announced Quartzsite, Ariz. as its first highway charging location and recently announced four California NEVI corridor 7 sites: Tehachapi, North Edwards, Barstow and Kramer Junction. National Electric Vehicle Infrastructure (NEVI) corridor 7 is one of the six corridor groups included in round 1 of the California Energy Commission’s NEVI Formula Program, which has announced the availability of up to $40,500,000 in grant funds for projects that will strategically deploy high-powered, direct-current fast charger electric vehicle charging infrastructure.
Businesses interested in securing their own NxuOne™ EV Charging Solutions, whether to power their own EV fleets or to contribute to the much-needed EV charging infrastructure more and more consumers are demanding every day, can learn more at: https://nxuenergy.com/charging-station-sales
This is huge news! Thanks,
The closing bid price for the Company's ordinary shares had fallen below $1.00 per share for 33 consecutive business days and accordingly, the Company no longer complies with the minimum bid price requirement for continued listing on the Nasdaq Capital Market pursuant to the Nasdaq Listing Rule 5550(a)(2). However the Nasdaq Listing Rules also provide the Company a compliance period of 180 calendar days (i.e. by June 24, 2024) in which to regain compliance. If the Company chooses to implement a reverse stock split, it must complete the split no later than ten business days prior to June 24, 2024 (i.e. June 7, 2024).
Great job Ghos Trader! Way to go!!!!!!!!!! I love hearing about these kind of things
NEWS
Evaxion Announces Completion of ADS Ratio Change
COPENHAGEN, Denmark, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, today announced that the Company’s previously disclosed change to its ratio of its American Depositary Shares (“ADSs”) to its ordinary shares, DKK 1 nominal value (the “ADS Ratio”), has been made effective. The ratio has changed from one (1) ADS representing one (1) ordinary share to a new ADS Ratio of one (1) ADS representing ten (10) ordinary shares (the “ADS Ratio Change”). The ADS Ratio Change became effective on January 22, 2024 (the “Effective Date”).
For the Company's ADS holders, the change in the ADS Ratio has the same effect as a one-for-ten reverse ADS split and is intended to further support the liquidity in the Company’s ADSs and to enable the Company to regain compliance with the Nasdaq minimum bid price requirement. The exchange of one (1) new ADS for every ten (10) then-held (existing) ADSs occurred automatically on the Effective Date, with the then-held ADSs being cancelled and new ADSs being issued by The Bank of New York Mellon, the depositary bank (the “Depositary”). Registered holders of the Company’s ADSs held in certificated form were required on a mandatory basis to surrender their certificated ADSs to the Depositary for cancellation and received one (1) new ADS in exchange for every ten (10) existing ADSs then-held. Holders of uncertificated ADSs in the Direct Registration System (DRS) and The Depository Trust Company (DTC) had their ADSs cancelled and automatically exchanged, receiving one (1) new ADS for every ten (10) existing ADS then-held. The Company’s ADSs continue to be traded on The Nasdaq Capital Market under the ticker symbol “EVAX”.
The ADS Ratio Change affects all shareholders uniformly and will not alter any shareholder’s percentage interest in the Company’s equity, except to the extent that the ratio change would have resulted in a shareholder owning fractional ADSs. No fractional new ADSs were issued in connection with the change in the ADS Ratio. Instead, fractional entitlements to new ADSs will be aggregated and sold by the Depositary, and the net cash proceeds from the sale of the fractional ADS entitlements (after deduction of fees, taxes and expenses) will be distributed to the applicable ADS holders by the Depositary.
As a result of the ADS Ratio Change, the ADS trading price is expected to increase proportionally, although the Company can give no assurance that the ADS trading price after the ADS Ratio Change will be proportionally equal to or greater than the previous ADS trading price prior to the change or that the Ratio Change will have any effect on the liquidity in the Company’s ADSs.
The public doesn't know the secret hence a secret but do you think the CEO would buy 1 million dollars worth of stock out of his own money if he didn't know that he has a Gorilla to turn loose? He would have to be a madman if he just did it as a potluck.
Insiders are allowed to buy inside info just as long as he or she files a Form 4. This is not like blackjack where maybe the next hand is a winner. I see no maybes and that is what I love so much about investing as we can read between the lines. Just a simple vision.
The real opportunity to buy cheap was right here during the $ 1.50's dip because MRAI has a secret weapon yet to be announced. :) Now I am smiling
No.....Wish I did. :(