Coya Therapeutics’ CEO Dr. Howard Berman’s Letter to Stockholders Mon, June 12, 2023, 7:00 AM EDT In this article: COYA 0.00% Watchlist Pattern Bullish HOUSTON, June 12, 2023--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, today released the following letter to stockholders from its Chief Executive Officer and Chairman, Dr. Howard Berman. Dear Fellow Stockholders, It’s hard to believe it’s now 6 months since our IPO closed on January 3rd of this year. We launched our IPO into one of the toughest biotech capital markets in recent memory and are enormously grateful to all our investors for the confidence they then showed in our prospects. I believe that to date, we’ve executed strongly against the goals we then established, and I remain excited about our future. I’d like to take this moment, mid-way through the year, to share some observations on what we’ve accomplished, what we’ve learned, and where we intend to take our company. As promised, we have now generated what we consider strong clinical proof of concept (POC) data in Alzheimer’s Disease (AD) and Amyotrophic Lateral Sclerosis (ALS). We believe this data is driving excitement for our regulatory T cell (Treg)-modulating approach and represents the first in an ongoing series of important catalysts we believe we can deliver throughout this year and next. Momentum is building. Moreover, we will continue to look for business development opportunities that I believe have the potential to dramatically expand our options for ongoing stockholder value creation. We intend to pursue catalysts and milestones in 2023 and 2024 that we expect will drive our success. A Deeply Personal Mission: Like many of you, I lost a parent, my dad, to the debilitating effects of neurodegenerative disease. I was profoundly affected watching this triple board-certified physician endure the slow decline of neurodegenerative disease…a passive observer to the loss of his formidable intellect and his inability at the end to find solace from loving family and friends. Fortunately, my dad was able to receive care from Dr. Stanley Appel, a distinguished clinician and researcher at the Houston Methodist Research Institute, and now a trusted collaborator and Chairman of our Scientific Advisory Board. I came to learn of the groundbreaking work Dr. Appel was doing in understanding the biology and therapeutic potential of Tregs. As I studied Dr. Appel’s findings and spent time with him and his colleagues, we saw a compelling opportunity to bring this new science into a commercial venture focused on driving the potential of Tregs out of the lab and towards approved therapeutics meeting obvious and urgent patient needs. No longer a passive observer, we now had a calling to get to work. Biologics Company Harnessing the Power of Treg Therapeutics: While the early work coming out of Dr. Appel’s lab was with Treg cellular therapeutics, we have now taken that fundamental know-how and rapidly developed two biologic programs, COYA 302 and COYA 301, each of which is aimed at enhancing Treg function. Additionally, we believe these two programs may also confer the advantages biologic drug products have in manufacturability, patient administration, and regulatory pathway. Certainly, our big news during the first half of 2023 was the data we released in March for COYA 302 showing positive results in a POC open-label study in ALS patients and then in May and again in June for COYA 301 showing positive results in a POC open-label study in AD. In the POC COYA 302 study in ALS, disease progression in patients was halted out to 24 weeks with minimal decline out to 48 weeks as measured by ALSFRS, the most commonly accepted ALS functional scale. This was notable since the study patient population had been declining markedly prior to treatment. 24 weeks is an important timepoint as this is the period that ALS studies are usually benchmarked to measure differences in the ALSFRS scale for a treatment vs. placebo. To stabilize or show even a slight improvement at 24 weeks is rarely, if ever, seen in this disease. Moreover, the identification of highly promising blood biomarkers correlating to responsiveness of the treatment was observed which we believe provides further objective evidence of mechanism of action. We intend to present and/or publish this biomarker data in the second half of 2023 and will plan on leveraging that biomarker data in our Phase 2 trial design. As we assess our progress at mid-year, we believe our stockholders will be best served by laser focusing our financial resources and managerial energy on COYA 302 in ALS and COYA 301 in AD. COYA 302—Conducting a Meaningful Double-blind Trial in ALS: Based on the POC data we released in March, we now intend to design a well-powered and well-controlled study to demonstrate the safety and efficacy of Coya 302 in patients with ALS. We are preparing for a pre-IND meeting with the U.S. Food and Drug Administration (FDA) in the fall of 2023 and hope to have our IND application accepted by the FDA early next year with a Phase 2 trial expected to begin soon thereafter. Obviously, our study design will reflect guidance from the FDA, but based on our current thinking, we believe a meaningful study can be run in a cost-effective manner and within a relatively short time duration (due to the standard 24-week endpoint). COYA 302—Leveraging a Meaningful Biomarker Associated with Treg Therapy in ALS: The recent approvals of Relyvrio® and Qalsody™ highlight the unmet medical need in ALS and provide helpful guidance on a regulatory pathway. Qalsody was recently granted accelerated approval based on the reduction of neurofilament light chain, a marker of neurodegeneration. Encouraging biomarker data from our COYA 302 ALS POC study and in other longitudinal cohort analyses are pointing to a blood biomarker/s related to oxidative stress that are consistently lowered with successful Treg-modulating treatment. We plan to present this data in the second half of 2023. Importantly, we anticipate that our study design for COYA 302 will include these biomarkers that may assist in adding robustness to our study. Certainly, having a correlative blood biomarker in ALS may prove very useful in regulatory interactions. COYA 301—Awaiting the Results of an Academic Investigator Initiated Randomized Double-blind Phase 2 Trial in AD: The data that emerged from our COYA 301 POC trial in AD was highly encouraging. In this small study, cognitive function, as measured by three validated tools, either improved or did not decline. Treg function was significantly enhanced, blood cytokines and chemokines were significantly reduced with evidence of reduced neuroinflammation in the brain. We find the correlation of objective data points with cognitive function assessments to be exciting. Therefore, in further support of COYA 301 in AD and other diseases, we recently announced the appointment of a world-renowned immunologist, Dr. Guillaume Dorothee, to our Scientific Advisory Board. Dr. Dorothee was the first person to publish the impact of Tregs in AD, the therapeutic role of low dose IL-2 in enhancing Tregs in AD, and the drug’s restoration of cognitive function in AD mice models. Currently, an ongoing academic Phase 2 double blind randomized trial (funded by the Gates Foundation and the Alzheimer’s Association) for use of low dose IL-2 in mild to moderate AD patients is underway at Houston Methodist (led by Dr. Alireza Faridar and Dr. Stanley Appel) and we anticipate reporting top line data in Q2 2024. This study is enrolling up to 46 patients and assessing Treg function, blood biomarkers, cerebrospinal fluid biomarkers (among them Aβ42, Tau, and phospho-Tau), Positron Emission Tomography (PET) pre and post imaging scans, cognitive function, and safety. Our design and plan for a larger trial will be informed by this study. With all this said, we now believe it is premature to continue to study COYA 301 in frontotemporal dementia. Business Development Deals May Unlock Additional Value Along the Way: Which brings me to our emerging business development strategy. We consider the POC data for COYA 302 and COYA 301 both as encouragement to continue our development of these therapeutics, but also as encouragement to evaluate the merit of COYA 301 in combination with other therapeutic agents. ( stoney here I have heard rumors that this combining works well! ) Partnerships with COYA 301 as a backbone therapy: Much like in Oncology, in which the field of immunotherapy is focused on combination therapies that target multiple pathways to evade resistance, the same may apply in neurodegeneration which is also driven by complex and multiple mechanisms. We believe that business development opportunities will continue to expand in leveraging COYA 301 as a backbone therapy in combination with other product candidates. Our early research points us to opportunities in combination with cytokine inhibitors or possibly ferroptosis inhibition. We believe this strategy is best executed in partnership with others who have therapeutic agents of interest. I am delighted that Arun Swaminathan joined us in April of 2023. He is a first-class business development executive who rapidly executed company transformative deals at each of his prior companies. Arun is actively engaged in exploring potential strategic opportunities across our portfolio of assets as we believe successful partnering efforts have the potential to enhance our scientific bona fides, leverage our technology into new areas of unmet medical need, and importantly, possibly secure upfront fees and associated non-dilutive funding. We look forward to pursuing additional value creation catalysts that further highlight our entrepreneurialism and ability to execute, while maintaining focus on our core assets. As I said at the outset, we are very grateful to our investors and take seriously our responsibility for the careful investment of the funds entrusted to us. We have always been conscientious in our spending and will continue that discipline as we progress in our development. I want you to know that my goals and your goals are completely aligned, and I remain keenly focused on building equity value at Coya and assure you that my colleagues share that commitment. We will do everything within our power to drive safe, effective treatments for patients while creating long-term value for our stockholders. I look forward to ongoing communication and thank you for your continued support. With gratitude, Dr. Howard Berman
You mean the pre-market quote that has it up 5%? That little birdie? Oh I forgot... that doesn't count. We'll ignore that.
" CHINA CONSIDERING BROAD STIMULUS PACKAGE " Just confirmed. Of course considering is not quite doing but... cats out of the bag. At this point I would welcome an AI robot from China to chat.... I can't believe we have no children from China!!! We have Australia We have Singapore! No China? No Elite TRADERS in China...
(Bloomberg) -- China’s central bank surprised most economists and market participants by cutting a short-term policy interest rate, a sign that officials are increasingly concerned about faltering growth and are stepping up stimulus to boost the recovery. The People’s Bank of China lowered the seven-day reverse repurchase rate by 10 basis points to 1.9% on Tuesday, the first reduction in the rate since August 2022. That increases the likelihood the central bank will reduce its one-year loan rate on Thursday, with banks expected to lower their lending rates shortly after. Tuesday’s move underlines heightened concern about a slowdown in growth: recent economic indicators showed inflation remained near zero in May, manufacturing activity contracted and an early rebound in the property market has fizzled. Speculation is growing that the PBOC may cut interest rates even further this year, while Beijing is considering a broad package of stimulus measures. “Policymakers are finally acknowledging the economic weakness,” said Michelle Lam, Greater China economist at Societe Generale SA. “There should be more interest rate and reserve requirement ratio cuts in the second half of 2023.” Goldman Sachs Group Inc. economists forecast a 25 basis-point cut to the reserve requirement ratio for lenders — which will free up more money for banks to boost lending — in the third quarter. Another cut to the ratio or policy rates could happen in the fourth quarter depending on the economy’s performance, they wrote in a research note Tuesday.
Q to the board- So I don't know my original password for Firefox// and in the past when new versions come out I try and downlode and it asks for that password and I have to exit. Can I drag my Firefox into the trash and flush it and start over by downloading Firefox from the web? My fear is I could end up with no gateway. Whats up with Chrome?
BFH))))))) Year-over-year change in average credit card and other loans Net loss rate 8.4% vs 6.2% BREAD FIN->Delinquency rate 5.5 % VS 4.0% ________________________________________________
Sounds like an interesting Barons article-- Retail Shoplifting Is Getting Worse. Retailers Are Fighting Back. By Sabrina Escobar Updated June 13, 2023 8:24 am ET / Original June 13, 2023 2:00 am ET Retail theft is on the rise—but companies are putting up a fight.