Aggressive Periodontitis

Accessible Care for Seniors Signing Up for Medicare Benefits DALLAS, Nov. 20, 2023 /PRNewswire/ -- Open enrollment for Medicare began on October 15. Millions of seniors in Texas once again faced the challenge of finding the right Medicare coverage, including the need to decide between Original Medicare or Medicare Advantage plans. While the primary focus is on medical and prescription coverage, it is important not to ignore the potential impact of dental coverage. Most Medicare participants don't realize the program does not include routine, preventive dental procedures, which are critical to longevity and overall health. Currently, Medicare benefits only apply to surgical dental procedures carried out in hospitals. As a result, seniors must either pay for dental services completely out-of-pocket or try to find a Medicare supplement that provides high-quality, affordable and accessible dental care. Unfortunately, this is extremely difficult. Most Medicare dental supplements are low-cost and poorly designed. In addition, these plans have very limited networks of inexperienced dentists. "We see the challenges seniors face in this situation, which is one reason why we offer our dental membership plans," commented Dr. Jay Patel, who practices at Midtown Family Dentistry of Dallas. He continued, "We simplify the search for experienced and knowledgeable dentists and provide the care seniors need at a reasonable rate. Our adult plan allows everyone to enjoy friendly, personalized care at a consistent, low monthly fee." Furthermore, the negative impact of poor dental care on the overall health of seniors can be significant. A range of statistics tell the story: Only 29% of seniors have dental coverage. 1 in 5 adults aged 65 or older have no natural teeth remaining, and complete tooth loss becomes twice as prevalent by age 75. People who still have 20 or more teeth at age 70 are significantly more likely to have a longer lifespan than those with fewer teeth. 70% of adults over the age of 65 have advanced periodontitis. This is the leading cause of adult tooth loss. In Texas, nearly 4 million senior citizens struggle with periodontal disease – a disease that has been strongly linked to heart disease, Alzheimer's, diabetes, and other serious conditions. While dental membership plans have existed for more than 20 years, most patients are unaware of this option. At the same time, ease of use and enrollment are two of the most significant benefits. Other facts to know about the savings plan at Midtown Family Dentistry of Dallas include: Between 2 dental examinations and cleanings per year included at a fixed cost per month. Benefits are available upon enrollment without any waiting period. Fluoride varnish and X-rays for the year. 20 percent discounts on other treatment, excluding Invisalign and braces. As seniors consider these benefits, it is important to keep a couple of dates in mind. Open enrollment for Medicare started on October 15, 2023, and ends December 7, 2023. This is the time to drop an existing dental supplement that is not working and to enroll in a better form of coverage. Those interested in learning more should feel free to contact Midtown Family Dentistry of Dallas on their website or by calling the office at (469) 780-7844. Contact Information: Website for Midtown Family Dentistry of Dallas: Dr. Jay Patel Dr. Scott Ludlow Dr. Tuan Nguyen 13309 Monfort Dr. Dallas, TX 75240 Amanda Campbell, Client Relations TNT Dental 2100 North Collins Boulevard Richardson, TX 75080 Primary Media Contact: Amanda Campbell [email protected] 877-868-4932 SOURCE Midtown Dallas Dentistry

Sub-group analyses of patients with early Parkinson's disease (PD) at different age groups or baseline disease severities who were treated with P2B001 showed consistently greater symptomatic control versus its components (pramipexole 0.6 mg and rasagiline 0.75 mg) and comparable efficacy to currently marketed, optimally titrated, extended-release pramipexoleData analysis also showed P2B001 to be consistently superior to currently marketed, optimally titrated, extended-release pramipexole on the Epworth Sleepiness Scale (ESS) score, which is especially important for younger people with PD leading active lives and for older people who typically cannot tolerate dopamine agonist side effects such as excessive daytime sleepiness (EDS) REHOVOT, Israel, Aug. 28, 2023 (GLOBE NEWSWIRE) -- Pharma Two B, a private, late-stage pharmaceutical company, today announced that sub-group analysis results from the Phase 3 pivotal clinical trial evaluating P2B001 are being presented at the 2023 The International Parkinson and Movement Disorder Society® annual meeting, August 27-31, in Copenhagen, Denmark. The data are being presented as a poster presentation on Monday, August 28. In all subgroups, the results demonstrate greater symptomatic benefit of P2B001 versus its components, and comparable efficacy with currently marketed, optimally titrated, extended-release pramipexole, yet with reduced EDS. EDS is a commonly reported side effect among people with PD, which often worsens with dopamine agonist therapy1: The efficacy and safety profile of P2B001 was not significantly different in younger versus older patients (<66 vs >66 years), nor when patients were analyzed by baseline severity (≤29 vs >29 Total-Unified Parkinson’s Disease Rating Scale (UPDRS) score).Across all subgroups, P2B001 provided numerically greater symptomatic benefit versus its components, as assessed by Total-UPDRS, and statistically significant greater benefit in Activities of Daily Living (UPDRS Part II) versus components.Across all subgroups, P2B001 provided comparable symptomatic efficacy versus currently marketed, optimally titrated, extended-release pramipexole.P2B001 was consistently superior to extended-release pramipexole across all subgroups on ESS scores. In the full study cohort, there was significantly less daytime sleepiness compared to extended-release pramipexole at 12 weeks (-2.66 points; p≤0.001). “This study's findings, demonstrating greater symptomatic benefits of P2B001 as compared to its individual components in patients of all ages and disease severities, support the potential usage of P2B001 in patients with early PD. Moreover, the data showed comparable efficacy to the established extended release pramipexole regimen titrated to optimal dosage, exemplifying a potential approach to optimizing patient care, while challenging traditional paradigms,” says Drew Falconer, M.D., of the Inova Parkinson’s and Movement Disorders Center, and a trial investigator. Dan Teleman, CEO of Pharma Two B, adds, “We are encouraged by the consistency of the Phase 3 trial's sub-group analyses. They reinforce our commitment to advancing P2B001 and improving the lives of people with Parkinson's disease.” About the Study The international, multicenter, randomized, double-blind, parallel-group study in adult patients (35-80 years old) with early, untreated PD (<3 years from diagnosis) compared once-daily P2B001 with its individual components, as well as to optimally titrated, extended-release pramipexole (mean dose of 3.2 mg). A total of 544 participants were enrolled and randomized into the study. The primary endpoint was change from baseline to Week 12 in Total-UPDRS score (sum of Parts II and III) comparing P2B001 to its individual components. The key (first) secondary endpoint was the change from baseline to Week 12 in the ESS score comparing P2B001 to the optimized dosage of extended-release pramipexole. For the current analyses, subgroups were categorized by age (< median of 66 years vs > median of 66 years) and baseline severity ( median of 29 of Total-UPDRS (Part II+III scores)). The data are consistent with the positive Phase 3 topline efficacy and safety results presented previously, reemphasizing the potential of P2B001, if approved, to offer a new treatment approach for people with early PD, despite their age. About P2B001 P2B001 is an investigational, novel, fixed-dose, extended-release combination of pramipexole and rasagiline (0.6 mg/0.75 mg), both at low doses that are not commercially available. Marketed pramipexole and rasagiline are currently indicated for the treatment of Parkinson’s disease (as monotherapy and adjunct therapy for early and more advanced patients). P2B001 is being developed for potential use as a first-line therapy for people of all ages with PD. Extended-release rasagiline is a new and proprietary formulation of rasagiline developed by Pharma Two B. Pharma Two B owns worldwide-granted patents for P2B001 for both pharmaceutical composition and method of treatment, which are expected to remain in force until January 2033. About Pharma Two BPharma Two B is a private, venture-backed, late-stage pharmaceutical company established in 2008 in Rehovot, Israel. Our mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders with a clear unmet need, that are based on previously approved oral drugs and that offer meaningful clinical benefits, as well as improved safety and enhanced convenience through easier administration. The company is led by a team highly experienced in PD, supported by top-tier scientific and clinical key opinion leaders, and backed by a dedicated group of investors. For more information, please visit: www.pharma2b.com. Forward Looking StatementsSome of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “will,” “expect,” “could,” “if,” “expected,” “anticipate,” ”look forward,” “believe,” “potential,” “propose,” and “continue,” or negative variants of such terms. These and similar forward-looking statements discuss the company’s future expectations and plans. The company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially. Although the company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the company cannot and does not guarantee future results, levels of activity, performance, or achievements. Moreover, the company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results. 1 Amara et al, J Neurol Neurosurg Psychiatry, 2017; Suzuki, J Park Dis, 2021; Avorn et al, Arch Neurol, 2005. Contact:Dan TelemanCEOPharma Two B Ltd.Cell. + 972-54-550-0804email: dan@pharma2b.com www.pharma2b.com U.S. media contact:Cali MangelAssociate DirectorCali.Mangel@calciumusa.com 215-694-1577

BERWYN, Pa.--(BUSINESS WIRE)-- Annovis Bio, Inc. (NYSE: ANVS), a late-stage clinical drug platform company developing transformative therapies to treat neurodegenerative diseases, including Alzheimer’s Disease (AD) and Parkinson’s Disease (PD) announced second quarter financial results for the period ended June 30, 2023, and reviewed recent accomplishments. Second Quarter 2023 Highlights and New Developments Clinical Updates AD phase II/III study 52 sites have been activated and 201 patients have been screened through June 30: 61 patients have been enrolled to receive either one of three doses of buntanetap or placebo. This is a dose ranging trial of buntanetap (formerly known as posiphen or ANV401) in patients with mild to moderate Alzheimer’s Disease with a dosing treatment period of 12 weeks. Its mechanism of action, favorable toxicology profile, and oral mode of administration distinguish buntanetap as superior to other AD drugs. Other drugs attempt to remove just one neurotoxic protein and, at best, have a minor effect. Buntanetap has been shown to effectively stop the synthesis of four neurotoxic proteins -Amyloid Beta, Tau, alpha Synuclein, and TDP43 - the culprits behind nerve cell degeneration and death. Buntanetap’s early trials have shown its ability to reverse the destructive effects that Alzheimer’s Disease has on thinking and memory. PD phase III study On June 3, Annovis announced it had reached full enrollment in the trial in a record nine months. Since the first patient was dosed in late August 2022, over 640 patients were screened and a total of 520 patients enrolled with 67 sites (43 in the United States and 24 in the European Union). The phase III trial is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap for early PD patients on top of their standard of care. By lowering levels of all the neurotoxic proteins, buntanetap improves axonal transport (the nerve cell’s information highway), which has been shown to be the cause of nerve cell degeneration and, ultimately, death. The record enrollment and low drop-out rate in this trial are believed to be due to the drug’s benefits demonstrated in the I/II trial: It showed improvements in both body and motor function. It is easily administered as a once daily pill. It is safe and well-tolerated. The study is expected to conclude in November with top-line assessment data available by the end of the year. Annovis announced on June 20 the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase III trial of buntanetap for PD. The DSMB recommended that Annovis continue the trial as originally designed. The feedback from the DSMB included: There were no drug-related SAEs (serious adverse events). Each AE (adverse event) was less than 2 percent. The dropout rate was 6 percent – significantly below expectations. Patients enrolled well ahead of the expected timeline: 9 months to enroll 523 patients. The planned enrollment has been achieved and based on this DSMB endorsement, Annovis expects topline results by the end of 2023. Patents Annovis announced on June 27, 2023, the creation of a novel crystalline form of buntanetap (ANVS402) and the filing of a new composition of matter provisional patent with the U.S. Patent and Trademark Office. (ANVS402 is covered by a composition of matter claim as well as multiple claims for chronic and acute neurodegenerative diseases and for neuropsychiatric indications.) This composition of matter patent is a trailblazing patent for any pharmaceutical company developing a new drug; ANVS402 is the same essential drug as the previous form but offers structural advantages, including: better stability higher purity longer half-life, improving buntanetap’s effectiveness. Approval of this patent will come with protection of ANVS402 and all its uses for a 20-year patent term. This significant time frame will enable Annovis to continue working on its robust pipeline, moving forward expeditiously toward developing novel drug therapies for many neurodegenerative diseases. Financial Results (for the quarter ending June 30, 2023) Cash and cash equivalents were $15.7 million. Research and development expenses for the quarter were $8.2 million, compared to $4.0 million for the same period in 2022. The increase was primarily the result of an increase of $4.2 million in clinical expenses, as Annovis incurred costs related to its phase III study in early Parkinson’s Disease (PD) and its phase II/III Alzheimer's Disease (AD) study. General and administrative expenses for the second quarter were $1.5 million, compared to $1.9 million for the same period in 2022. The decrease was primarily the result of a decrease of $0.5 million in stock-based compensation expense, partially offset by an increase in salaries and professional fees of $0.1 million. Annovis reported a net loss of $9.5 million for the quarter, compared to a net loss of $5.9 million for the same period in 2022. Staff News New Employees In May, Annovis hired Sarah MacCallum as senior clinical project manager, bringing the total employee count to 10. Annovis scientists spoke at events featuring novel approaches in neurodegenerative diseases with other leaders in the life sciences and pharmaceutical industries: Cheng Fang, Ph.D., Senior Vice President of Research and Development, hosted a roundtable discussion on “Emerging Non-Amyloid Targets for Alzheimer’s Disease” at the CNS Therapeutics Xchange-East Coast 2023 in Boston on May 24. She also presented a poster on buntanetap's novel target and mechanism of action for Alzheimer’s disease. Maria Maccecchini, Ph.D., CEO, was a member of a panel titled “Optimizing the Pipeline” at the Longwood Healthcare Leaders Spring MIT Conference, held June 7-8 at MIT’s Koch Institute in Cambridge. Annovis presented three posters at the Alzheimer’s Association International Conference (AAIC) 2023 annual meeting held in Amsterdam, Netherlands, from July 16-20. Dr. Fang presented two posters: “Do Mouse Data Lie? For Buntanetap, They Totally Predict Human Outcome,” and “Interim Analysis Results of Buntanetap in Phase III Clinical Studies in Alzheimer’s and Parkinson’s Disease. A third poster was presented by Don Elbert, Ph.D., associate professor of neurology, University of Washington School of Medicine, in collaboration with Annovis through the ongoing national Alzheimer’s Disease Cooperative Study (ADCS), titled “Stable Isotope Labelling Kinetics: Models and Methods to Evaluate APP Production Rates with Posiphen Treatment in the DISCOVER Clinical Trial.” The posters’ combined findings tell the story of an exceptionally promising treatment for neurodegenerative diseases such as AD and PD. First, in a mouse model of AD, buntanetap inhibits toxic proteins in the brain, improves axonal transport, lowers inflammation, and protects nerve cells from dying, all of which is associated with improved movement and cognition. Second, these findings are also replicated in all the human AD and PD phase I and II trials to date. Third, in both mice and humans, there is also evidence of a dose-response relationship between the drug dose administered and the inhibition of the neurotoxic proteins - important in determining the optimal dosage in future phase II and III trials. Message from Dr. Maria It is tremendously rewarding and important that our drug is safe, well-tolerated, and easily administered as a once-a-day pill. The two FDA-approved drugs for Alzheimer’s Disease require I.V. infusions and repeated brain imaging, and have well-documented, serious side effects that manifest as brain swelling or brain bleeding. As buntanetap continues to show significant progress through clinical trials, we remain on course and anticipate having topline data with good news to share before the end of the year. The positive momentum we’re building with this drug is reflected in the more than 200% annual growth rate of our company over the last two years. The crystalline form of buntanetap will allow us to have a new 20-year patent protection for Annovis Bio to continue to move forward. There’s growing interest and excitement in the scientific and investment communities about our drug’s very real potential to not just alleviate devastating neurodegenerative disease symptoms but ultimately change the course of the diseases themselves. –Maria L. Maccecchini, Ph.D., Annovis Founder, President, and CEO About Buntanetap Buntanetap (previously known as ANVS401 or posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), whose mode of action leads to a lower level of neurotoxic proteins and consequently less toxicity in the brain. In a Phase I/II clinical trial in AD and PD patients, buntanetap was shown to be well-tolerated and its pharmacokinetics were found to be in line with levels measured earlier in humans, meeting both the primary and secondary endpoints. Additionally, exploratory endpoints were also met, as treatment with buntanetap resulted in statistically significant improvement in motor function in PD patients and cognition in AD patients. Presently buntanetap is being studied in a phase III study in early PD patients and in a Phase II/III study in mild to moderate AD patients. About Annovis Bio, Inc. Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s Disease (AD), Parkinson’s Disease (PD), and other chronic neurodegenerative diseases. It is believed to be the only company developing a drug for both AD and PD designed to inhibit more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the company’s goal is to treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. Annovis conducted two phase I/II studies: one in AD patients and one in both AD and PD patients. In the AD/PD study buntanetap showed improvements in cognition in AD as well as movement and function in PD patients. For more information on Annovis Bio, please visit the Company's website and follow us on LinkedIn, Facebook, Twitter and Threads. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding patient enrollment, the effectiveness of buntanetap and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety and tolerability of buntanetap. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. SOURCE: Annovis Bio