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Hey Gail. Are you in this one? I took some $1.05's
Looks excellent dino!
All your efforts through the months to save investors with your sarcastic and cruel ways of posting backfired on you. You deserve it, Miles. Instead of trying to save investors you should try and save yourself! Wonder how many stayed away from making big $$$$$'s because of you?
Oh ok. Thanks for the reply. I'm only in it for today. :)
GOP senators: Halt travel with China to stop ‘mystery illness’
https://www.politico.com/news/2023/12/01/republican-senators-china-travel-unknown-pathogen-00129638
This came out a few minutes ago. Purdue veterinarians investigating atypical respiratory illness in dogs
https://www.indystar.com/story/news/2023/12/04/purdue-college-of-veterinary-medicine-disease-investigation-for-atypical-respiratory-illness-in-dogs/71740648007/
Old management stole from the Company. She is gonna either bring in new management or maybe sell the Company
https://www.otcmarkets.com/filing/html?id=17095632&guid=_uJ-kerQaTi8dth
$13.91 new 52-week high! On November 27, 2023, Direct Digital Holdings, Inc. (the “Company”) entered into that certain Second Amendment (the “Amendment”) to the Credit Agreement, dated July 7, 2023 (the “Existing Credit Agreement”), by and among East West Bank (“EWB”), as lender, and Direct Digital Holdings, LLC, the Company, Huddled Masses LLC, Colossus Media, LLC and Orange142, LLC, as borrowers (collectively, “Borrowers”). Under the terms of the Amendment, pursuant to Section 2.07 of the Existing Credit Agreement, Borrowers have requested and EWB has agreed to increase the aggregate size of the revolving facility from $5,000,000 to $10,000,000. Accordingly, the new commitment under the Existing Credit Agreement means that EWB is obligated to make available revolving credit advances in an aggregate principal amount up to but not exceeding $10,000,000.
Brad Jacobs to Lead Equity Investment of $1 Billion in SilverSun Technologies and Pursue Acquisitions in an Industry to be Announced Later
Jacobs to Become Chairman and Chief Executive Officer
Company to Become Platform for Jacobs' New Venture after Spinning Off Existing SilverSun Business
GREENWICH, CT and EAST HANOVER, NJ / ACCESSWIRE / December 4, 2023 / SilverSun Technologies, Inc. (Nasdaq:SSNT) ("SilverSun" or the "Company") and Jacobs Private Equity II, LLC ("JPE"), which is led by Brad Jacobs, today announced that they and minority co-investors have entered into an investment agreement (the "Investment Agreement"), pursuant to which JPE and the minority co-investors will invest $1 billion in cash into SilverSun. The proposed equity investment is comprised of $900 million by JPE and $100 million by co-investors, including Sequoia Heritage.
Upon the closing of the equity investment, JPE will become the majority stockholder of SilverSun and Jacobs will become the Company's chief executive officer and chairman of its board of directors. The Investment Agreement also provides for the spin-off of the Company's existing business to SilverSun stockholders as of a record date that is expected to be one day prior to the closing of the investment. The remaining Company will become a standalone platform for significant acquisitions in an industry to be announced soon, along with the company's new name.
Jacobs said, "I'm excited to start building another multibillion-dollar company from scratch. Soon, I'll be providing more information about my new venture and industry, and the strategy we plan to execute."
Jacobs has completed approximately 500 M&A transactions in his career, and built five multi-billion dollar, publicly traded companies to date: XPO, Inc., one of the largest providers of less-than-truckload services in North America; GXO Logistics, Inc., the largest pure-play contract logistics provider in the world; RXO, Inc., a leading tech-enabled freight brokerage platform; United Rentals, Inc., the world's largest equipment rental company; and United Waste Systems, Inc., the fifth largest U.S. waste management company at the time of its sale.
Each of these companies has a history of attracting world-class talent, establishing advantages through technology, and scaling up through accretive capital allocations for M&A and organic growth.
The Investment Agreement
Under the terms of the Investment Agreement, the Company will, shortly after the closing of the investment, separate ("spin off") the existing SilverSun business as SilverSun Technologies Holdings, Inc. (the "spin-off company") and distribute all shares of the spin-off company to the stockholders of SilverSun as of a record date that is expected to be one day prior to the closing of the equity investment. The Company will also effect an 8:1 reverse stock split prior to the closing of the equity investment. Upon the closing of the investment and the effectiveness of the reverse stock split, JPE, Sequoia Heritage and the other co-investors will have: (i) voting, convertible preferred stock that, in aggregate, is convertible into approximately 219 million shares of the Company's common stock at a price of $4.57 per share (equivalent to $0.57 per share pre-split); and (ii) warrants to purchase an additional approximately 219 million shares of the Company's common stock at post-reverse-split exercise prices of: $4.57 per share (equivalent to $0.57 per share pre-split) with respect to 50% of the warrants, $6.85 per share (equivalent to $0.86 per share pre-split) with respect to 25% of the warrants, and $13.70 per share (equivalent to $1.71 per share pre-split) with respect to the remaining 25% of the warrants. Following the closing of the investment, JPE and the co-investors will own approximately 99.85% of the Company's common stock on a fully convertible/exchangeable basis.
In addition, SilverSun will declare a $2.5 million aggregate cash dividend to its stockholders as of the same record date, to be funded from proceeds received under the Investment Agreement. The transactions contemplated by the Investment Agreement have been approved by SilverSun's board of directors, and are expected to be completed in 2024. The transactions are subject to SilverSun stockholder approval and the satisfaction of other customary closing conditions.
The Company's current management and board of directors, including Mark Meller, SilverSun's chief executive officer, are expected to continue in their current roles at the spin-off company and its subsidiaries. The spin-off company will apply for a public listing of its shares, which will be registered pursuant to a Form 10 registration statement that will be filed with the U.S. Securities and Exchange Commission.
Meller said, "We believe this investment agreement will provide ideal outcomes for our stockholders, customers and employees, including the opportunity for our stockholders to realize a substantial upfront cash payment in the form of a $2.5 million dividend. We expect our stakeholders will benefit from retaining the value of our existing business, while also participating in the potential upside of Brad Jacobs' future business plans for the company."
Goldman Sachs and Morgan Stanley are serving as financial advisors to JPE, and Wachtell, Lipton, Rosen & Katz is serving as legal advisor.
The Benchmark Company, LLC is serving as financial advisor to SilverSun, and Lucosky Brookman LLP is serving as legal advisor.
Cautionary statement regarding forward-looking statements
This press release contains forward-looking statements. Statements that are not historical facts, including statements about beliefs or expectations, are forward-looking statements. These statements are based on plans, estimates, expectations and projections at the time the statements are made, and readers should not place undue reliance on them. In some cases, readers can identify forward-looking statements by the use of forward-looking terms such as "may," "will," "should," "expect," "opportunity," "intend," "plan," "anticipate," "believe," "estimate," "predict," "potential," "target," "goal," or "continue," or the negative of these terms or other comparable terms. Forward-looking statements involve inherent risks and uncertainties and readers are cautioned that a number of important factors could cause actual results to differ materially from those contained in any such forward-looking statements. Factors that could cause actual results to differ materially from those described in this press release include, among others:
uncertainties as to the completion of the equity investment (the "initial investment"), the separation by SilverSun Technologies, Inc. (the "Company") of its existing business into SilverSun Technologies Holdings, Inc. (the "spin-off") and the other transactions contemplated by the investment agreement by and among Jacobs Private Equity II, LLC, the Company and the other parties thereto (the "Investment Agreement"), including the risk that one or more of the transactions may involve unexpected costs, liabilities or delays;
the risks associated with the Company's relatively low public float, which may result in its common stock experiencing significant price volatility;
the possibility that competing transaction proposals may be made;
the risks associated with raising additional equity or debt capital from public or private markets to pursue acquisitions or other strategic investments, including in an amount that may significantly exceed the initial equity investment, and the effects that raising such capital may have on the Company's business and the trading price of the Company's common stock, including the possibility of substantial dilution;
the possibility that additional future financings may not be available to the Company on acceptable terms or at all;
the effects that the announcement, pendency or consummation of the equity investment, the spin-off and the other transactions contemplated by the Investment Agreement may have on the Company and its current or future business and on the price of the Company's common stock;
the possibility that an active, liquid trading market for the Company's common stock may not develop or, if developed, may not be sustained;
the possibility that the warrants, if issued, may not be exercised;
the possibility that various closing conditions for the equity investment, the spin-off and the other transactions contemplated by the Investment Agreement may not be satisfied or waived, or any other required consents or approvals may not be obtained within the expected timeframe, on the expected terms, or at all, including the possibility that the Company may fail to obtain stockholder approval for the transactions contemplated by the Investment Agreement;
the effects that a termination of the Investment Agreement may have on the Company, including the risk that the price of the Company's common stock may decline significantly if the equity investment is not completed;
the risk that the spin-off may be more difficult, time-consuming or costly than expected or the possibility that the anticipated benefits of the spin-off may not be realized;
uncertainties regarding the Company's focus, strategic plans and other management actions;
the risk that the Company, following the closing of the equity investment, is or becomes highly dependent on the continued leadership of Jacobs as chairman and chief executive officer and the possibility that the loss of Jacobs in these roles could have a material adverse effect on the Company's business, financial condition and results of operations;
the risk that Jacobs' past performance may not be representative of future results;
the risk that the Company is unable to attract or retain world-class talent;
the risk that the Company may be unable to identify suitable acquisition candidates or expeditiously consummate any particular acquisition candidate on acceptable terms or at all;
the risk that the failure to consummate an acquisition expeditiously, or at all, could have a material adverse effect on the Company's business prospects, financial condition, results of operations or the price of the Company's common stock;
the risk that the Company may fail to satisfy the ongoing requirements of Nasdaq if it is unable to expeditiously consummate an acquisition following the consummation of the spin-off;
the risks associated with cybersecurity and technology, including attempts by third parties to defeat the security measures of the Company and its business partners, and the loss of confidential information and other business disruptions;
the possibility that new investors in any future financing transactions could gain rights, preferences and privileges senior to those of the Company's existing stockholders;
the risks associated with the uncertain nature of the industry in which Jacobs, upon becoming chairman and chief executive officer of the Company, plans to pursue acquisitions after consummation of the transactions contemplated by the Investment Agreement;
the risks associated with potential litigation related to the transactions contemplated by the Investment
Alterity Therapeutics Reports Positive Efficacy Data for ATH434 in a Primate Model of Parkinson’s Disease
- ATH434 improved motor performance and general function –
- Webcast to be held this week to discuss new data and recent clinical progress –
MELBOURNE, Australia and SAN FRANCISCO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that promising new data on the effect of ATH434 in a Parkinson’s disease primate model was presented at the Future of Parkinson’s Disease Conference 2023 that took place November 30 – December 3, 2023 in Austin, TX, USA.
The poster, entitled, “Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in Hemiparkinsonian Macaques”, was presented by Margaret Bradbury, PhD, Vice President of Research and Nonclinical Development at Alterity and collaborators from Vanderbilt University Medical Center and the Florey Institute of Neuroscience in Melbourne. The presentation demonstrated that ATH434 treatment improved motor performance and general function in monkeys with experimentally induced Parkinson’s disease. The favorable impact on Parkinson’s symptoms was associated with lower iron levels in the area of pathology. In addition, ATH434 treatment increased levels of synaptophysin, a protein marker that reflects functional connections between neurons.
David Stamler, M.D., Chief Executive Officer of Alterity, commented, “These new data are exciting because we have shown for the first time that ATH434 can reduce Parkinson’s symptoms in a higher order animal – the monkey. Importantly, the improvements in motor skills and general functioning that parallel human parkinsonism were associated with reductions in iron in affected brain regions, validating the approach we are using in our ongoing clinical trials. The data from this study improve our ability to predict clinical outcomes and increases our confidence level in our ongoing Phase 2 clinical trials in Multiple System Atrophy, a parkinsonian disorder with similar underlying pathology to Parkinson’s disease.”
The study compared daily oral doses of ATH434 (3 or 10 mg/kg) versus a vehicle (placebo) for 12-14 weeks after parkinsonian symptoms were evident. Monkeys were assessed with the Parkinson Behavior Rating Scale (PBRS) before, during and after dosing. At Week 12, all evaluable ATH434-treated monkeys (n=5) had stable or improving PBRS scores from Baseline to Week 12 whereas two of three vehicle-treated monkeys did not demonstrate improvement or worsened, as expected from the progressive nature of the Parkinson model. The components of the PBRS scale indicate that ATH434 reduced motor impairment and improved general functions such as posture, balance, activity, and gait. Favorable parkinsonian outcomes observed in each of the ATH434-treated monkeys were associated with lower iron in the right substantia nigra. In addition, monkeys with improved scores had higher right dorsal striatal synaptophysin, indicating functional recovery of nerve endings in this critical motor pathway.
The poster presentation can be accessed on the Published Scientific Research section of the Alterity website here.
Webcast details
AUSTRALIA PARTICIPANTS:
Date: Wednesday, 6 December 2023
Time: 9:00 a.m. AEDT (Sydney/Melbourne)
UNITED STATES PARTICIPANTS:
Date: Tuesday, 5 December 2023
Time: 2:00 p.m. Pacific Time
5:00 p.m. Eastern Time
Register for the Zoom webcast:
https://us02web.zoom.us/webinar/register/WN_9Lv1OWMtSSSqdJrRsKRiTA#/registration
Registration is required and dial in details will be sent directly upon registration.
About ATH434
Alterity’s lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce a-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain. As an iron chaperone, it has excellent potential to treat Parkinson’s disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal
EyePoint Pharmaceuticals Announces Positive Topline Data from the Phase 2 DAVIO 2 Trial of EYP-1901 in Wet AMD Achieving All Primary and Secondary Endpoints
– Both EYP-1901 cohorts demonstrated a statistically non-inferior change in BCVA versus aflibercept control with a numerical difference of only -0.3 and -0.4 letters, respectively for the 2 mg and 3 mg dose at blended six-month endpoint –
– Positive safety profile continues with no EYP-1901-related ocular or systemic SAEs –
– Key secondary endpoints were achieved with both EYP-1901 doses. These include an over 80% reduction in treatment burden, with nearly two-thirds of eyes supplement-free up to six-months –
– Strong anatomical control in both EYP-1901 cohorts documented by optical coherence tomography (OCT) –
– Conference call to discuss the results to be held today, December 4, 2023 at 8:00 a.m. ET –
WATERTOWN, Mass., Dec. 04, 2023 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901, an investigational sustained delivery maintenance treatment for wet age-related macular degeneration (wet AMD) combining vorolanib, a selective tyrosine kinase inhibitor with bioerodible Durasert E™. The clinical trial met its primary endpoint with both EYP-1901 doses demonstrating statistical non-inferiority change in best corrected visual acuity (BCVA) compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs). The trial also achieved key secondary endpoints with both EYP-1901 doses, including an over 80% reduction in treatment burden, nearly two-thirds of eyes supplement-free up to six months and over 80% receiving only zero or one supplement up to six-months. Additionally, there was strong anatomical control with both EYP-1901 cohorts as measured by optical coherence tomography (OCT).
“We are incredibly pleased by these highly positive Phase 2 results which underscore EYP-1901’s potential as a paradigm-altering maintenance treatment for patients with wet AMD, with a positive safety profile. Since EYP-1901 achieved statistical non-inferiority to the aflibercept control in this trial there is potential for meaningfully lower sized and lower cost pivotal Phase 3 trials,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. “I would like to thank the patients and the investigators who participated in the DAVIO 2 trial as well as our employees who helped advance us to this important milestone.”
Dr. Duker continued, “the DAVIO 2 clinical trial was designed to support the initiation of Phase 3 clinical trials based on feedback received from the U.S. Food and Drug Administration (FDA) at a Type C meeting last year. The 32-week topline DAVIO 2 data strongly supports our planned Phase 3 non-inferiority design, consistent with the FDA’s recent guidance for wet AMD clinical trials. We look forward to continuing our dialogue regarding our Phase 3 plans with the FDA as we prepare to initiate our first pivotal trial for wet AMD in the second half of 2024.”
“These highly positive Phase 2 results are the result of years of hard work by the dedicated EyePoint team coupled with our proven Durasert technology which continues to demonstrate the benefit of zero order kinetics drug delivery. I look forward to initiation of Phase 3 and potentially bringing this innovative and much needed new drug to market for patients suffering from these blinding eye diseases,” said Nancy Lurker, Executive Vice Chair of EyePoint Pharmaceuticals. “I want to congratulate the EyePoint team on the continued execution of this program.”
DAVIO 2 topline interim results include:
Both EYP-1901 doses (2mg and 3mg) achieved all primary and secondary endpoints.
Statistical non-inferiority in change in BCVA (at a confidence interval of 95%) compared to aflibercept control, at weeks 28 and weeks 32 combined. The 2mg and 3mg doses were only -0.3 and -0.4 letters different, respectively, versus on-label aflibercept. The lower limit of the non-inferiority margin is defined as a -4.5 letters by the FDA with 5 letters representing one line on the eye chart.
Continued positive safety and tolerability profile with no EYP-1901-related ocular or systemic SAEs.
89% and 85% reduction in treatment burden, respectively, for the 2mg and 3mg EYP-1901 doses.
65% and 64% of eyes were supplement free up to six-months, respectively, for the 2mg and 3mg doses of EYP-1901.
Both EYP-1901 doses demonstrated strong anatomic control with OCT difference below 10 microns at week 32 compared to the aflibercept control.
Patient discontinuation up to week 32 was low at 4%.
“Wet AMD is a prevalent and progressive lifetime disease. With frequent treatment, patients can maintain their visual acuity, but the unfortunate reality is that many patients end up undertreated due to the burden of dosing of the currently available, short-acting anti-VEGF therapies,” said Carl Regillo, M.D., Chief of Retina Service at Wills Eye Hospital. “I am very encouraged by the data generated from both the Phase 1 DAVIO and Phase 2 DAVIO 2 trials with the latter showing essentially no difference in visual outcome at the blended six-month endpoint from a single injection of EYP-1901 compared to on-label, bimonthly aflibercept injections. Based on the meaningful reduction in treatment burden and supplement-free rates observed, along with the consistently favorable safety profile, I believe that EYP-1901 could be a paradigm shift in how patients with wet AMD are treated.”
DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in previously treated patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary non-inferiority efficacy endpoint is change in BCVA compared to the aflibercept control, approximately six-months after the EYP-1901 injection. Secondary endpoints include safety, change in CST as measured by OCT, the number of eyes that remain free of supplemental anti-VEGF injections, and number of aflibercept injections in each group. More information about the trial is available at clinicaltrials.gov (identifier: NCT05381948).
EyePoint plans to present the DAVIO 2 dataset at Angiogenesis, Exudation, and Degeneration 2024 in February.
The Company remains on track to reach additional clinical milestones with EYP-1901 with the initiation of the Phase 2 VERONA trial in diabetic macular edema (DME) anticipated in the first quarter of 2024 and the readout of topline data from the Phase 2 PAVIA trial in non-proliferative diabetic retinopathy (NPDR) anticipated in the second quarter of 2024.
Conference Call and Webcast Information
EyePoint will host a conference call today, December 4, 2023 at 8:00 a.m. ET to discuss the results. To access the live conference call, please register at https://register.vevent.com/register/BI4c4d93355a394ea284131d7b537fd513. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.
About Wet AMD
Age-related Macular Degeneration (AMD) is a leading cause of irreversible blindness or vision loss in people over the age of 60. Wet AMD is an advanced form of the condition that develops when abnormal blood vessels grow into the macula, leaking blood or fluid that leads to scarring of the macula and potentially rapid and severe vision loss. Wet AMD is a lifelong disease that requires continuous treatment so that patients may maintain visual function. Although multiple treatments are now available, challenges still exist as the current standard-of-care is dosed on average every two months in the United States under a treat-and-extend protocol, and these large molecule anti-VEGF treatments only target one pathology of the disease. This lifetime of frequent treatment represents a tremendous burden for patients, physicians, and the health care system, potentially leading to patient noncompliance and further vision loss.
About EYP-1901
EYP-1901 is being developed as a potential paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases. EYP-1901 delivers vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) formulated in a solid bioerodible insert using EyePoint’s proprietary sustained-release Durasert E™ technology. Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases as a pan-VEGF receptor blocker, blocking all VEGF isoforms. Vorolanib features reduced off-target binding and at clinically relevant doses does not inhibit Tie-2, a critical pathway associated with vascular stability, which may result in an improved efficacy. Further, in an in-vivo model of retinal detachment, vorolanib demonstrated neuroprotection, and potential antifibrotic benefits. EYP-1901 is shipped and stored at ambient temperature and is administered with a single intravitreal injection in the physician's office. EYP-1901 is immediately bioavailable, featuring an initial burst of drug, followed by near constant zero-order kinetic release for approximately nine months.
Positive data from both the Phase 1 DAVIO and Phase 2 DAVIO 2 clinical trials of EYP-1901 in wet AMD demonstrated clinically meaningful efficacy data with stable visual acuity and OCT, and a favorable safety profile. Further, the recent DAVIO 2 data demonstrated an impressive treatment burden reduction of over 85% at six months, and over 80% of patients remained supplement-free or only received one supplemental anti-VEGF injection up to 6 months. The data from the DAVIO 2 clinical trial supports the advancement of the wet AMD program to Phase 3 pivotal trials which are anticipated to initiate in the second half of 2024.
EYP-1901 is also being studied in non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME). The Phase 2 PAVIA trial in NPDR is fully enrolled with topline data anticipated in the second quarter of 2024. The Phase 2 VERONA trial in DME is planned to initiate in the first quarter of 2024.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The company’s lead product candidate, EYP-1901, is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases. Additional pipeline programs include EYP-2301, a promising Tie-2 activator, razuprotafib, f/k/a AKB-9778, formulated in Durasert E™ to potentially improve outcomes in wet AMD and diabetic eye disease. The proven Durasert® drug delivery platform has been safely administered to over thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. For more information visit www.eyepointpharma.com.
EYEPOINT SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901 and EYP-2301; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME); the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals including potential U.S. Food and Drug Administration (FDA) regulatory approval of EYP-1901 and EYP-2
I sent a message to the contact page at the https://floridaanimalcontrol.org/contact-us/
Potentially fatal mystery illness in dogs is spreading in Florida
Animal Humane Society is now responding to the doggie respiratory outbreak
Did you speak to Famela Ramos about that?TIA
Top of the morning to you trader53
The outbreak of the mysterious illness has spread to dogs across the country. This is a pandemic for all dogs. Wonder if TSOI QuadraMune which works well on human respiratory disease can work for dogs? https://www.nationalgeographic.com/animals/article/dogs-illness-respiratory-outbreak-us
https://www.amazon.com/stores/page/F45418FE-30DC-4CF3-AD4F-55FDECDD2795
The most current info on Weiss = WEISS REVOCABLE TRUST
WEISS STEVEN J & THERESA A TRS
168 AGNEW ST
LAS VEGAS
NV 89138
https://maps.clarkcountynv.gov/assessor/assessorparceldetail/parceldetail.aspx?hdninstance=pcl7&hdnparcel=13727620047
What dog owners need to know about unknown respiratory illness https://www.wbay.com/2023/12/01/what-dog-owners-need-know-about-unknown-respiratory-illness/
A new 52-week high hit today. 12.85
HCDI = There are 2,329,322 shares of common stock outstanding as of November 9, 2023. I just got off the phone with Albert Einstein and he can't figure it out.
Good morning DRCT. December is here babe. Let's crank this to $20 before the new year!
Hey JMC$ how are you, my friend? Yes, tons of excitement ahead for DPLS. Gonna be fun
Dog respiratory illness prompts warning https://www.recordcourier.com/news/2023/nov/30/dog-respiratory-illness-prompts-warning/
NLS Pharmaceutics Announces Exclusive Option Agreement to Develop and Commercialize Next Generation Dual Orexin Agonist Platform of Aexon Labs, Inc.
The option agreement grants NLS Pharmaceutics Ltd. the exclusive option to in-license all of Aexon Labs' assets for the potential treatment of narcolepsy and other neuro-degenerative disorders, and all future indications
Exclusive option agreement accesses global rights to multiple highly selective Orexin-1 / Orexin-2 receptor agonists, unique compounds designed for specificity, acting multiple pathways involved in the pathophysiology of narcolepsy and other central disorders of hypersomnolence
Additional targets include Cathepsin-H inhibition, sigma-1 receptor agonist, DAT and NET reuptake inhibition, addressing neurotransmission, neuroprotection and neuroinflammation
First patent application filed at the end of 2022 for orexin receptors agonists for treating or preventing neurological diseases and psychiatric disorders including narcolepsy
NLS continues to strengthen its neuroscience pipeline in sleep medicine with a unique and holistic approach to central disorders of hypersomnolence and neurodegenerative disorders franchise
ZÜRICH, SWITZERLAND / ACCESSWIRE / December 1, 2023 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system ("CNS") disorders, today announced that NLS has entered into an exclusive worldwide option agreement with Aexon Labs, Inc., a privately held U.S. company ("Aexon Labs"), under which NLS may acquire global development and commercialization rights to Aexon Labs' Dual Orexin Receptor Agonists platform, new molecular entities, highly selective dual oral orexin-1 and orexin-2 receptor agonists (OX1R and OX2R) with potential applications in the treatment of narcolepsy and idiopathic hypersomnia, as well as neuro-degenerative disorders such as Parkinson's and Alzheimer's disease. This option agreement represents a potentially leading next-generation, first-in-class, oral, dual orexin receptor agonist (AEX-2) that is expected to address high unmet medical needs and has shown promising results in pre-clinical in vitro assays. Aexon Labs has plans to initiate clinical development, including Phase 1 First-in-Human and Phase 1b Proof-of-Concept (POC) studies, as early as 2024.
The transaction will be structured as an exclusive worldwide license for the development and commercialization by NLS of the Aexon Labs' compounds and their derivatives. Under the terms of the option agreement, NLS must exercise its option by no later than March 31, 2024. NLS will pay Aexon Labs an upfront payment of $30,000 for the option exclusivity, and $170,000 upon execution of the definitive agreement to exercise the option. In addition, Aexon Labs will receive 15% of all proceeds earned by NLS in any future sub-licensing agreements which include upfront payments, regulatory milestones, commercial milestones and royalties earned during the first three years of commercialization in the U.S. and in the EU. Royalties will be payable, on a country-by-country basis, from the date of first commercial sale of a product in a given country until the date of patent expiry or the entry of a generic version of the product in such country.
NLS will be the sole party responsible for the design and execution of the research and development plan, for the conduct and management of the preclinical as well as clinical studies, and for the interactions with the U.S. Food and Drug Administration and/or any other regulatory agency. NLS will pay all costs associated with executing and completing those studies, as well as those associated with the preparation and submission of a new drug application. NLS will pay for all studies in all indications and regulatory filings in the U.S. as well as outside of the U.S.
Eric Konofal, MD, PhD, who works under a part-time consulting agreement for NLS as its Chief Scientific Officer, is the president and founder of Aexon Labs, and owns 59% of Aexon Labs. Alexander Zwyer, Chief Executive Officer of NLS, owns 35% of Aexon Labs. Mr. Zwyer holds no board or executive position at Aexon Labs.
Mr. Zwyer said, "I believe the potential acquisition of this novel and unique platform which consists of over 300 compounds, bridges the present to the future treatment of sleep disorders as well as other neuro-degenerative disorders. These new compounds, in addition to our current pipeline, including Mazindol ER for the treatment of narcolepsy, along with NLS-4 focused on idiopathic hypersomnia, long-COVID and chronic fatigue syndrome, and NLS-11, addressing Kleine-Levin Syndrome and neurodegenerative diseases will further complement and strengthen our hypersomnia franchise."
Orexin receptor pathways play vital regulatory roles in many physiological processes and studies have shown that orexin receptor pathways are involved in pathological processes of neurological diseases such as narcolepsy, depression, ischemic stroke, drug addiction and Alzheimer's disease.
About Narcolepsy
Narcolepsy is a life-long sleep disorder caused by the autoimmune-mediated loss of 70,000-90,000 orexin-producing neurons in the hypothalamus, characterized by excessive daytime sleepiness, cataplexy and rapid eye movement sleep abnormalities, and is tightly associated with human leukocyte antigen HLA-DQB1*06:02. Other predisposing factors for narcolepsy are associations with a polymorphism in the T-cell receptor alpha and beta genes, whose products recognize antigens presented by human leukocyte antigens (HLA) molecules, and Cathepsin H (CTSH).
About NLS Pharmaceutics Ltd.
NLS is a global development-stage biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders who have unmet medical needs. Headquartered in Switzerland and founded in 2015, NLS is led by an experienced management team with a track record of developing and commercializing product candidates. For more information, please visit www.nlspharma.com.
About Aexon Labs, Inc.
Aexon Labs is conducting leading edge research on new compounds to address unmet needs in neurodegenerative disorders, defined by the breakdown of neurons over time. Alzheimer's, Parkinson's, Huntington's, Narcolepsy and Amyotrophic Lateral Sclerosis are just a few examples of brain disorders that have no cure. Current treatments do not address the root cause of each disorder and often lack therapeutical effectiveness and safety for these neurological disorders. For more information, please visit www.aexonlabs.com.
Safe Harbor Statement
This press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses the potential benefits of NLS' and Aexon Labs' products, development plans and timing of studies, and the timing and the expected outcome of the option agreement. These forward-looking statements and their implications are based on the current expectations of the management of NLS only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS' products may not be approved by regulatory agencies, NLS' technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; NLS may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with NLS' process; NLS' products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; NLS' patents may not be sufficient; NLS' products may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; and loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading "Risk Factors" in NLS' annual report on Form 20-F for the year ended December 31, 2022 filed with the Securities and Exchange Commission (SEC), which is available on the SEC's website, www.sec.gov, and in subsequent filings made by NLS with the SEC.
For additional information:
Marianne Lambertson (investors & media)
NLS Pharmaceutics Ltd.
+1 239.682.8500
ml@nls-pharma.com
www.nlspharmaceutics.com
SOURCE: NLS Pharmaceutics AG
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https://www.accesswire.com/812085/nls-pharmaceutics-announces-exclusive-option-agreement-to-develop-and-commercialize-next-generation-dual-orexin-agonist-platform-of-aexon-labs-inc
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