Disabilities Special Needs Dentist Duncanville Forth Worth TX Updates Services

Disabilities Special Needs Dentist Duncanville Forth Worth TX Updates Services




Disabilities Special Needs Dentist Duncanville Forth Worth TX Updates Services

Disability Dental is now providing an updated range of special needs dentistry services to patients of all ages in Duncanville, Fort Worth TX, and the surrounding area.

Duncanville, United States, June 19, 2021 (GLOBE NEWSWIRE) — Disability Dental announced an updated range of dentistry services for special needs patients in Duncanville, near Fort Worth TX. The dental practice can help patients with Alzheimer’s disease, Cerebral Palsy, developmental disabilities, physical disabilities, intellectual disabilities, Parkinson’s disease, autism, Down syndrome, and mental retardation.

More information can be found at https://www.disabilitydental.com/

They see folks who are unable to be seen in a regular dental office. There are anesthesiologists on staff and specialized wheelchair-accessible dental tools and chairs.

The new announcement is part of the dental center’s commitment to providing high-quality dental services to special needs patients, helping them to maintain optimal oral health.

Many disabilities are associated with an increased risk for various oral health problems. Special needs dentistry is a specialty of dentistry that focuses on providing dental care to patients with special needs or disabilities. To ensure proper diagnosis and treatment, it is very important to choose a dentist who specializes in this type of dentistry and can meet the specific needs of these patients in a comfortable setting.

Dr. Frank E. Ford DDS, BS and the team at Disability Dental believe that everyone deserves to have a strong, healthy, and beautiful smile. That is why they provide dental examination, dental and maintenance to patients with special needs.

The dental experts are highly trained in caring for patients with special needs and have more than 50 years of combined experience in treating their unique dental needs. They customize each patient’s treatment and appointment to meet their comfort level and needs.

Disability Dental can also file the dental insurance on the patient’s behalf. However, patients are advised to be prepared to pay the deductible and the copay.

Dr. Frank earned his Bachelor of Science in Dentistry from Baylor University and received his Doctor of Dental Surgery from University of Texas Dental Branch at Houston. He has been serving patients in the DFW Metroplex for 25 years.

Dr Ford adds “For 40 years, I’ve had a special place in my heart for taking care of the special needs, disabled or handicapped folks. It’s not every now and again here, it’s full-time, and we only treat special people.”

Interested parties can find more by visiting https://www.disabilitydental.com/patients-with-disabilities.html

Website: http://www.disabilitydental.com/

CONTACT: Name: Dr Frank Ford
Organization: Disability Dental
Address: 107 N Cedar Ridge Dr #100, Duncanville, TX 75116, United States
Phone: +1-972-296-0101

Invisalign Midtown East NY Clear Aligner Therapy For Teeth Straightening Updated

Invisalign Midtown East NY Clear Aligner Therapy For Teeth Straightening Updated




Invisalign Midtown East NY Clear Aligner Therapy For Teeth Straightening Updated

Modern Dental of Manhattan (+1-212-758-1000) announced that its custom Invisalign clear aligner treatment is now available to patients dealing with a range of orthodontic conditions in Midtown east, Tudor City, Diamond district, Murray hill, and other surrounding neighborhoods in Manhattan, New York.

New York, United States, June 19, 2021 (GLOBE NEWSWIRE) —

Midtown East, New York-based Modern Dental of Manhattan has updated its range of cosmetic dentistry services to offer Invisalign clear aligner therapy for patients who want to enhance the aesthetics of their smile.

They are conveniently located near Diamond District, Lenox Hill, Murray Hill, NY postcodes 10017, 10174, 10167, 10022 and 10175. More details are available at https://manhattandentists.com/invisalign-clear-aligners-midtown-east/

The updated service includes the treatment of various orthodontic conditions such as irregularly shaped teeth, crossbite, overbite, under-bite, and others with clear, removable aligners.

Invisalign treatment, as the dental care experts explained, involves using sets of removable braces to enhance a patient’s smile gradually. The aligners are made from SmartTrack, a patented thermoplastic material.

Unlike traditional metal braces, Invisalign is clear, thin, and invisible. Patients can remove the clear aligners at will; however, for the best results, the experts at Modern Dental of Manhattan recommend wearing the clear braces for up to 22 hours a day.

The team at Modern Dental of Manhattan works closely with each patient to create a custom treatment plan tailored to their unique needs. An Invisalign-trained dentist will assess the patient’s smile during the initial consultation and use a digital imaging technique to map a detailed plan to transform the patient’s smile.

Each set of aligners applies gentle, constant pressure on the teeth, gradually shifting them into place until the desired smile is achieved. Patients may be required to change to a new set every one to two weeks. It can 6-12 months to complete the treatment, though this depends mainly on the complexity of the patient’s case.

The Midtown East New York dental office is staffed by a team of multi-disciplinary, board-certified clinicians with decades of private practice experience and expertise to handle all patients’ cosmetic dentistry needs.

Patients can expect the highest level of service when they visit their dental office. The team strives to deliver quality dental care in a technologically advanced, clean, modern, and caring environment.

A company spokesperson said: “Invisalign clear aligners are FDA-approved and contain no BPA, BPS, latex, or gluten. They are thin, clear, and fit snugly over the teeth, making them virtually invisible. Above all, these clear aligners can help shift your teeth into place, giving you a beautiful smile you can be proud of.”

Interested parties can call +1-212-758-1000 to schedule a cosmetic dentistry consultation or visit https://manhattandentists.com to learn more.

Website: https://manhattandentists.com/

CONTACT: Name: Michael Yonaiev
Organization: Modern Dental of Manhattan
Address: 425 Madison Ave Suite 500, New York, NY 10017, United States

Biophytis announces new convertible bond financing for up to €32 million with Atlas and drawing of 2 tranches under the 2020 Atlas Contract for €6 million

Biophytis announces new convertible bond financing for up to €32 million with Atlas and drawing of 2 tranches under the 2020 Atlas Contract for €6 million




Biophytis announces new convertible bond financing for up to €32 million with Atlas and drawing of 2 tranches under the 2020 Atlas Contract for €6 million

PARIS and Cambridge, Mass., June 19, 2021 (GLOBE NEWSWIRE) — Biophytis SA (Nasdaq CM: BPTS, Euronext Growth Paris: ALBPS), (“Biophytis” or the “Company”), a clinical-stage biotechnology company focused on the development of therapeutics aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announces a new line of financing through Bonds Redeemable in Cash and New and Existing Shares (ORNANE) with Atlas, a specialized investment fund based in New York (United States), for €32 million (the “2021 Atlas Contract”). This line of financing will be used for further clinical development of Sarconeos (BIO101) in sarcopenia following our SARA phase 2 results and for the next development steps of the product in COVID-19 following our COVA phase 2-3 results, as well as the financing of the Company’s activities going forward.

The Company also announces the issuance of 240 ORNANE Bonds, for a total amount of €6 million under its existing convertible bond agreement with Atlas (the “2020 Atlas Contract”).

Stanislas Veillet, President and CEO of Biophytis, said: “We are pleased to conclude this new ORNANE contract with Atlas that allows us to secure the Company’s financing going forward. In the meantime, we have just drawn two tranches of convertible under the existing agreement with Atlas for a total of €6 million, that will enable Biophytis to i) source starting materials required for the coming production of registration and commercial batches – provided positive results from COVA, ii) to scale up manufacturing and industrialization activities and to iii) start the Expanded Access COVA Program. These activities are directly linked to the potential filing for Emergency Use Authorization in the U.S. and Conditional Marketing Authorisation in the EU later in 2021.”

a)  2021 Atlas Contract

The new financing instrument allows the issuance of 1280 bonds with an option for exchange in cash and/or conversion into new or existing shares (ORNANE). Subject to the issue of the eighth and last tranche under the 2020 Atlas Contract, the €32 million total financing can be drawn by Biophytis over the next three years, without obligation, through 8 successive tranches of €4 million each. This facility will secure the Company cash position, in order to continue the development of its clinical activities in particular further development of Sarconeos (BIO101). The risks inherent in this financing scheme are described in the “Risk Factors” section of the Company’s Annual 2020 Report available on BIOPHYTIS website (www.biophytis.com) and in the “Risk Factors” section of the Company’s registration statement on Form F-1 and other reports filed with the Securities and Exchange Commission (the “SEC”).

Legal framework
The issued securities will give Atlas access immediately or in the future to the Company’s share capital with cancelation of the shareholders’ preferential subscription rights to the benefit of a category of persons pursuant to Article L. 225-129 et seq. of the French Commercial Code.

Pursuant to the delegation granted by the General Meeting of Shareholders of 10 May 2021, the Company’s Board of Directors approved the conclusion of the 2021 Atlas Contract during its meeting on June 8, 2021. The 2021 Atlas Contract was concluded on 14 June 2021.

This offer of financial securities did not result in a prospectus subject to AMF approval.

The Company will keep the shareholders informed of the exercise of the ORNANE and the subsequent conversions, through a summary table of the ORNANE, and the number of shares in circulation, all of which will be available on the Company website.

Main characteristics of the ORNANE
The ORNANE will have a par value of €25 000 euros. They will not bear interest and will have a 24-month maturity from issuance. The holder of ORNANE may request at any time to convert them during their maturity period, and the Company shall have the right to redeem the ORNANE in cash. In case of cash redemption, the amount reimbursed will be limited to 110% of the principal.

At the end of the maturity period, and in the case where the ORNANE would not have been redeemed either in cash or in new or existing shares, the holder will have the obligation to convert the ORNANE.

The holder can ask to convert the ORNANE at any time at the conversion parity determined by the following formula: N = Vn / (R x P), where

  • “N” is the number of shares yielded by the conversion,
  • “Vn” is the par value of the ORNANEs, i.e., €25,000 each,
  • “R” is the conversion ratio, i.e., 1.00,
  • “P” is the conversion price, i.e., the Pricing Period VWAP during the Pricing Period of 10 trading days preceding the reception of the Conversion Notice

On the day of the conversion request, the Company may redeem the ORNANE in cash using the following formula: V = (Vn/P) * Pr, where

  • “V” is the amount to be redeemed to the holder.
  • “Pr” is the revised price.

The revised price is the lowest price between (i) the volume weighted average price over the 10 trading days preceding the date on which conversion is requested and (ii) P*1.10

ORNANE may be transferred by their holders only to Affiliates and will not be subject to a request for trading admission on the Euronext Growth market.

Number of securities and dilution (assumptions)
Based on the 113 854 795 outstanding shares, and based on issuance and conversion of a €4 million tranche, and of all tranches on 14 June 2021 and a conversion price equal to €0,9376, the impact on a shareholder’s 1% stake in the Company’s capital prior to the operation would be:

Impact on a shareholder’s 1% stake in the Company’s capital prior to the transaction Non diluted Diluted
     
Before issuing of new ORNANE 1.00 % 0.95 %
         
Upon conversion of one tranche of the new 2021 ORNANE contract from Atlas: issuing of 4 266 197 additional shares 0.96 % 0.92 %
         
Upon conversion of the totality of the new 2021 ORNANE contract from Atlas: issuing of 34 129 576 additional shares 0.77 % 0.74 %

b)  Drawing of 2 tranches of the 2020 Atlas Contract

On April 7, 2020, Biophytis announced a convertible line of €24 million from Atlas. The press release is available on the Company’s website (www.biophytis.com) in the section “2020 press releases”. The financing instrument allows the issuance of 960 ORNANE, at a par value of €25,000 each. The €24 million total financing can be drawn by Biophytis over the next 3 years, without obligation, through 8 successive tranches of €3 million each. The Company drew a first tranche of €3 million during April 2020, a second tranche of the same amount in July 2020, and a third tranche of €3 million in September 2020.
After the drawing of the 4th and 5th tranches for a total of €6 million, €9 million will remain from the current instrument.

Reminder of the main characteristics of the 2020 Atlas ORNANE contract issued
The ORNANE don’t bear interest and have a 24-month maturity from issuance. The holder of ORNANE may request at any time to convert them during their maturity period, and at that time, the Company will be able to redeem the ORNANE in cash. In case of cash redemption, the amount reimbursed will be limited to 115% of the principal.

Number of securities and dilution (assumptions)
As of June 14, based on 113, 854,795 outstanding shares, at the conversion on this day and a conversion price equal to 97% of the pricing period VWAP of €0.9094, dilution is reflected as follows:

Impact on a shareholder’s 1% stake in the Company’s capital prior to the transaction Non diluted Diluted
     
Before issuing of new ORNANE 1.00 % 0.95 %
         
Upon conversion of the ORNANE from tranches 4 &5 of Atlas: issuing of 6 597 212 additional shares 0.95 % 0.90 %

About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19. Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, being developed as a treatment for sarcopenia in a Phase 2 clinical trial in the United States and Europe (SARA-INT). It is also being studied in a clinical two-part Phase 2-3 study (COVA) for the treatment of severe respiratory manifestations of COVID-19 in Europe, Latin America, and the US. A pediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne Muscular Dystrophy (DMD). The company is based in Paris, France, and Cambridge, Massachusetts. The company’s common shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825) and ADSs are listed on Nasdaq Capital Market (Ticker BPTS – ISIN: US09076G1040). For more information visit www.biophytis.com

Disclaimer
This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “trends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. These forward-looking statements include statements regarding Biophytis’ anticipated timing for its various Sarconeos (BIO101) clinical trials and expectations regarding commercialization. Such forward-looking statements are based on assumptions that Biophytis considers to be reasonable. However, there can be no assurance that the statements contained in such forward-looking statements will be verified, which are subject to various risks and uncertainties including, without limitation, delays in patient recruitment or retention, interruptions in sourcing or supply chain, its ability to obtain the necessary regulatory authorizations, COVID-19-related delays, and the impact of the current pandemic on the Company’s clinical trials. The forward-looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered material by Biophytis. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. Please refer to the “Risk Factors” section of the Company’s Annual 2020 Report available on BIOPHYTIS website (www.biophytis.com) and to the risks discussed in the Company’s registration statement on Form F-1 and other reports filed with the Securities and Exchange Commission (the “SEC”). We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

Biophytis Contact for Investor Relations
Evelyne Nguyen, CFO
evelyne.nguyen@biophytis.com

Media contact
Life Sci Advisors
Sophie Baumont
E: sophie@lifesciadvisors.com
T: +33 6 27 74 74 49

Investor Relations
LifeSci Advisors, LLC
Chris Maggos
E: chris@lifesciadvisors.com

 

CORRECTING and REPLACING Study Shows Guardant Reveal™ Blood-Only Liquid Biopsy Test Predicts Risk for Colorectal Cancer Recurrence with Industry-Leading Sensitivity

CORRECTING and REPLACING Study Shows Guardant Reveal™ Blood-Only Liquid Biopsy Test Predicts Risk for Colorectal Cancer Recurrence with Industry-Leading Sensitivity




CORRECTING and REPLACING Study Shows Guardant Reveal™ Blood-Only Liquid Biopsy Test Predicts Risk for Colorectal Cancer Recurrence with Industry-Leading Sensitivity

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Please replace the release dated April 30, 2021, with the following corrected version due to changes in the fifth paragraph.

The updated release reads:

STUDY SHOWS GUARDANT REVEAL BLOOD-ONLY LIQUID BIOPSY TEST PREDICTS RISK FOR COLORECTAL CANCER RECURRENCE WITH INDUSTRY-LEADING SENSITIVITY

For patients with early-stage colorectal cancer (CRC), the presence of circulating tumor DNA (ctDNA) or minimal residual disease (MRD) after curative intent treatment is becoming an important prognostic biomarker for cancer recurrence, and can also be used to evaluate the potential need for adjuvant treatment in post-surgical patients. Until recently, tests developed to detect MRD required tumor tissue to gain the necessary genomic information needed to accurately identify high-risk patients. A new study led by Massachusetts General Hospital Cancer Center and published in Clinical Cancer Research demonstrates that Guardant Reveal, the first blood-only liquid biopsy to identify MRD, identifies those patients most likely to recur, with industry-leading sensitivity, without the need for tumor tissue. 1,2

The single-center, prospective study evaluated the effectiveness of the Guardant Reveal liquid biopsy test to detect MRD in patients with stage I-IV colorectal cancer after curative intent therapy. Blood draws were taken one month after completion of definitive treatment, either surgery or adjuvant therapy, and at various surveillance or monitoring timepoints. Blood samples were analyzed using the Guardant Reveal test, which integrates both cancer-specific epigenomic signatures and genomic alterations, unlike standard MRD tests which analyze only genomic alterations.

In the primary landmark analysis (n=84), blood samples were taken from the curative intent patient population one month (median 31.5 days) after completion of definitive treatment. In the subset of patients with at least one year of clinical follow-up, all patients with detectable ctDNA recurred (100% PPV). Guardant Reveal test sensitivity and specificity were 55.6% and 100% respectively for this single timepoint. By incorporating longitudinal surveillance samples, sensitivity improved to 91%. Integrating epigenomic signatures increased test sensitivity by 36% versus using genomic alterations alone. Additionally, CEA tests, the traditional biomarker for colorectal cancer, did not predict recurrence in this patient cohort.

“The integration of cancer-specific epigenomic and genomic signatures allows Guardant Reveal to detect minimal residual disease in early-stage colorectal cancers with industry-leading performance and without the need for tumor tissue,” said AmirAli Talasaz, Guardant Health president. “We believe that Guardant Reveal can be a powerful decision-making tool for oncologists managing patients with early-stage colorectal cancer. In addition, our blood-only approach offers a more streamlined workflow and faster turnaround time for clinical decision making.”

“By detecting minimal residual disease after curative intent treatment, we can have a better understanding of which patients are at high-risk for recurrence and perhaps tailor additional therapy,” said Aparna Parikh, MD, MPH, Gastrointestinal Oncologist at Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School. “This study demonstrates that the incorporation of epigenomic signatures with genomic alterations allows for Guardant Reveal to have high sensitivity and specificity, but without the need for tumor tissue.”

Tissue-dependent MRD tests have previously reported sensitivities of 40%-50% with a single post-surgical blood draw. 1,3 When looking only at the subset of patients with stage II or III CRC in this study, Guardant Reveal had a sensitivity of 63% and a specificity of 100% for recurrence. These data show that Guardant Reveal can detect minimal residual disease from a simple blood draw. In addition, the sensitivity of the test increases with additional longitudinal blood draws, allowing for earlier detection of recurrence in the patient surveillance setting compared with standard imaging methods.

The Guardant Reveal test achieves industry-leading sensitivity (91%) 2 for detecting ctDNA by simultaneously interrogating genomic and epigenomic alterations. The test accurately identifies genomic alterations down to allele frequencies of 0.01% and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis. The incorporation of biologically relevant epigenomic signatures is essential to increasing test sensitivity in the post curative intent and surveillance patient populations.

The publication titled, “Minimal Residual Disease Detection using a Plasma-Only Circulating Tumor DNA Assay in Colorectal Cancer Patients” can be found here.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets, and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched liquid biopsy-based Guardant360 ®, Guardant360 CDx, and GuardantOMNI ® tests for advanced stage cancer patients, and Guardant Reveal test for early-stage cancer patients. These tests fuel development of its LUNAR screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential scope, impact or benefit of Guardant Health liquid biopsies which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2020 as well as in its other reports filed with the Securities and Exchange Commission, including, when filed, its Quarterly Report on Form 10-Q for the period ended March 31, 2021. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

REFERENCES

1. Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncology. 2019; 5 (8): 1125-1131.

2. Parikh A, Van Seventer E, Siravegna G, Hartwig A, et al Minimal Residual Disease Detection using a Plasma-Only Circulating Tumor DNA Assay in Colorectal Cancer Patients. Clinical Cancer Research.

3. Tie J, Wang Y, Tomasetti C, Li L, Springer S, et al. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Science Translational Medicine. 2016; 8 (346): 346ra92.

Contacts

Investor Contact:
Carrie Mendivil

investors@guardanthealth.com

Media Contact:
Anna Czene

press@guardanthealth.com

Julie Johnson

julie.johnson@uncappedcommunications.com

Element Nutritional Sciences Announces Closing of $5 Million Bought Deal Private Placement

Element Nutritional Sciences Announces Closing of $5 Million Bought Deal Private Placement




Element Nutritional Sciences Announces Closing of $5 Million Bought Deal Private Placement

THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES.

BURLINGTON, Ontario–(BUSINESS WIRE)–Element Nutritional Sciences Inc. (CSE:ELMT) (“Element” or the “Company”) is pleased to announce that the Company has closed the “bought deal” brokered private placement with Canaccord Genuity Corp. (the “Underwriter”) as previously announced on June 4, 2021, for total gross proceeds of $5,000,400.

Each Unit consists of one common share of the Company and one half of one transferable common share purchase warrant (each whole common share purchase warrant, a “Warrant”). Each Warrant shall be exercisable into one common share of the Company for a period of 24 months from the closing date at an exercise price of C$1.00. The securities issued under or in connection with the private placement will be subject to a hold period expiring four months and one day following the issue date.

In connection with the private placement, the Company has paid the Underwriter a cash commission equal to 7% of the gross proceeds raised; issued broker warrants exercisable for common shares of the Company at a price of $0.60 per common share for a period of 24 months from the issue date; and paid a corporate finance fee of $125,000 payable in common shares of the Company.

The net proceeds raised from the private placement will be used for general corporate purposes.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

About Element

Element is an innovative and research driven Canadian nutraceutical company specializing in the development of science-based products for the global consumer packaged goods market, with a portfolio focused specifically on men and women over the age of 50. Element’s lead product, Rejuvenate, is a proprietary formulation that is clinically proven to assist in the rebuilding, restoration and rejuvenation of natural loss of muscle mass due to aging or other medical conditions. Element also offers JAKTRX, an elite brand of performance supplements. Element was founded in 2015 and is located in Burlington, Ontario.

On behalf of the Board of Directors

https://elmtinc.com/

FOR FURTHER INFORMATION PLEASE CONTACT:

ir@elementnutrition.com

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to the closing of the Offering and use of proceeds, predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to materially differ from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in the securities markets, fluctuations in general macroeconomic conditions; expectations regarding the size of the United States and Canadian health, nutraceutical and wellness markets and changing consumer habits; the viability of the Company’s products; availability of distribution channels for the Company’s product offerings; the ability of the Company to successfully achieve its business objectives; plans for expansion; successful development of the Company’s proposed products; the presence of laws and regulations that may impose restrictions or recalls on the sale of the Company’s products in the United States and Canada; customer and distributor relations; and the inability of the Company to obtain adequate insurance to cover risks and hazards. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Contacts

Stuart Lowther

Chairman, CEO and President

ir@elementnutrition.com
416-467-5229

Marc Charbin

Investor Relations

ir@elementnutrition.com
416-467-5229

AHF Files Federal Antitrust Lawsuit Against the PBM Prime Therapeutics

AHF Files Federal Antitrust Lawsuit Against the PBM Prime Therapeutics




AHF Files Federal Antitrust Lawsuit Against the PBM Prime Therapeutics

Lawsuit asserts Prime Therapeutics unlawfully fixes the prices of its reimbursements to AHF and other independent pharmacies, to align with reimbursements of a direct Prime competitor

LOS ANGELES–(BUSINESS WIRE)–Today, AIDS Healthcare Foundation (AHF), the leading provider of health care to people living with HIV/AIDS around the world, filed a lawsuit in federal court in Los Angeles to stop Prime Therapeutics LLC from fixing prices of reimbursements to AHF pharmacies, along with all other independent pharmacies doing business with Prime, for providing prescription drugs to patients in need. The action was filed in U.S. District Court, Central District of California (Case No. 2:21-cv-04979).

Prime is a pharmacy benefit manager (PBM), a “middle-man” in the distribution system for prescription drugs in the United States. In its capacity as a PBM, Prime acts as a gatekeeper between pharmacies and health insurers.1 The PBM boasts of administering the pharmacy-benefits components of health-insurance plans for about 33 million people in the United States. Some of those people are patients of AHF pharmacies, and, in 2020, Prime processed almost 100,000 drug prescriptions for AHF patients.

In late 2019, Prime announced “a new three-year collaboration” with another PBM, Express Scripts, Inc. The word “collaboration” suggests something complicated. In fact, it appears Prime is simply aligning its reimbursement rates with those of the other PBM, and doing so on an ongoing basis. AHF’s pleading asserts that Prime is thereby violating the most settled principle of antitrust law, the prohibition against fixing prices with a direct competitor.

Almost immediately after the “collaboration” went into effect in the spring of 2020, AHF noticed that it was being reimbursed less than before for providing the same pharmacy services to patients whose PBM is Prime. Indeed, those reimbursement rates now line up exactly with those of the other competitor PBM.

“The reimbursement money Prime has been unlawfully taking from AHF is money that can no longer fund the specialized care and lifesaving services that AIDS Healthcare Foundation offers to people living with HIV/AIDS — regardless of a patient’s ability to pay,” said Jonathan M. Eisenberg, Deputy General Counsel for AHF. “There is thus a real human cost here.”

With its lawsuit, AIDS Healthcare Foundation is now standing up to Prime, a powerful PBM that essentially controls access to many insured patients that use AHF pharmacies and healthcare centers, as well as on behalf of other independent pharmacies.

“AIDS Healthcare Foundation has real reason to fear that we may face retaliation from Prime for exposing it as a price-fixer,” added Eisenberg. “However, we take that risk on behalf of the patients and clients we serve and many other independent pharmacies to try to stop Prime’s flagrantly unlawful scheme.”

About the lawsuit, AIDS Healthcare Foundation President Michael Weinstein added, “PBMs are very powerful, and they always are tempted to squeeze pharmacies financially. Somehow Prime found out that it was giving larger reimbursements to pharmacies than another PBM. Apparently, Prime just could not leave a single dime on the table and resorted to fixing prices. AIDS Healthcare Foundation and its patients – and other independent pharmacies and their patients – are literally paying the price for that crime. But we are fighting back, and we are going to win.”

Here again is a link to a copy of the complaint: [Case No. 2:21-cv-04979].

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.5 million clients in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare

1 Note: Prime is, in fact, owned by a group of Blue Cross and/or Blue Shield health insurers.

Contacts

Ged Kenslea, AHF Communications Dir., gedk@aidshealth.org (323) 791-5526 cell

Ocugen Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) 

Ocugen Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) 




Ocugen Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) 

MALVERN, Pa., June 18, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced the Compensation Committee of the Board of Directors of Ocugen approved the grant of stock options to purchase an aggregate of 157,450 shares of its common stock and restricted stock units (RSUs) covering an aggregate of 26,300 shares of common stock to four new employees. The stock options and RSUs were granted as of June 15, 2021, as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock options have a ten-year term and have an exercise price of $6.26 per share, which is the closing price of Ocugen’s common stock on the grant date. The stock options and RSUs vest in equal annual installments over a three-year period starting on the one-year anniversary of the grant date, subject to the applicable new employee’s continued service with Ocugen through the applicable vesting dates. The stock options and RSUs were granted outside of Ocugen’s 2019 Equity Incentive Plan.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug — “one to many,” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, the intended use of net proceeds from the registered direct offering. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release. 

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com 

Baudax Bio Announces Special Meeting of Shareholders to Vote on Proposed Increase in Number of Authorized Shares of Common Stock

Baudax Bio Announces Special Meeting of Shareholders to Vote on Proposed Increase in Number of Authorized Shares of Common Stock




Baudax Bio Announces Special Meeting of Shareholders to Vote on Proposed Increase in Number of Authorized Shares of Common Stock

Special meeting to be held virtually on July 13, 2021, at 9:00 a.m. Eastern Time

MALVERN, Pa., June 18, 2021 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today announced that it has scheduled a Special Meeting of shareholders to approve its proposed increase of the number of authorized shares of common stock from 100 million shares to 190 million shares for Tuesday, July 13, 2021 at 9:00 a.m. Eastern Time. The proposal to increase the Company’s authorized shares of capital stock is set forth in its Definitive Proxy Statement filed with the Securities and Exchange Commission on June 14, 2021.

Leading independent proxy advisory firms Glass Lewis & Co. and Institutional Shareholder Services, Inc. have both recommended that Baudax Bio shareholders vote “for” the proposed additional authorized shares. The Special Meeting will be held virtually at www.virtualshareholdermeeting.com/BXRX2021.

All shareholders are encouraged to vote no matter how many shares you own. You are encouraged to submit your vote as soon as possible. Please submit your vote online at www.proxyvote.com or by telephone at 1-800-690-6903. Shareholders needing assistance voting or have questions may contact the Company’s proxy solicitation firm, Okapi Partners, at info@okapipartners.com or (855) 208-8902.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio’s first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

CONTACT:

Investor Relations Contact:

Argot Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:

Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com

Tarsus Pharmaceuticals, Inc. Schedules Conference Call and Webcast to Announce Saturn-1 Phase 2b/3 Pivotal Trial Results for TP-03 for the Treatment of Demodex Blepharitis

Tarsus Pharmaceuticals, Inc. Schedules Conference Call and Webcast to Announce Saturn-1 Phase 2b/3 Pivotal Trial Results for TP-03 for the Treatment of Demodex Blepharitis




Tarsus Pharmaceuticals, Inc. Schedules Conference Call and Webcast to Announce Saturn-1 Phase 2b/3 Pivotal Trial Results for TP-03 for the Treatment of Demodex Blepharitis

IRVINE, Calif., June 18, 2021 (GLOBE NEWSWIRE) — Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), a late clinical-stage biopharmaceutical company whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced it will hold a webcast and conference call on Monday, June 21, 2021 at 8:00 a.m. (ET) to provide a detailed summary of results from the Saturn-1 Phase 2b/3 pivotal trial for TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis and a brief corporate update.

The dial-in numbers are (833) 540-1160 for domestic callers and (929) 517-0351 for international callers. The Conference ID is 3766845. A live, listen-only webcast of the event can be accessed at https://edge.media-server.com/mmc/p/uh6zebmu.

After the live webcast, the event will remain archived on the Tarsus Pharmaceuticals website at https://ir.tarsusrx.com/ for 90 days.

About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. is a late clinical-stage biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care. It is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. The company is studying two investigational medicines in clinical trials. Its lead product candidate, TP-03, is a novel therapeutic being studied in two pivotal trials for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease. Tarsus is developing TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease, which is currently being studied in a Phase 1 clinical trial.

Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future; Tarsus may need to obtain additional funding to complete the development and any commercialization of its product candidates, if approved; Tarsus is heavily dependent on the success of its lead product candidate, TP-03 for the treatment of Demodex blepharitis; the COVID-19 pandemic may affect Tarsus’ ability to initiate and complete preclinical studies and clinical trials, disrupt regulatory activities, disrupt manufacturing and supply chain or have other adverse effects on Tarsus’ business and operations; even if TP-03, TP-05, or any other product candidate that Tarsus develops receives marketing approval, Tarsus may not be successful in educating eye care physicians and the market about the need for treatments specifically for Demodex blepharitis, Lyme disease, and/or other diseases or conditions targeted by Tarsus’ products; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus will need to develop and expand the company and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for Tarsus’ product candidates, particularly TP-03 for the treatment of Demodex blepharitis and MGD, as well as TP-05 for the treatment of Lyme disease, have not been established with precision and may be smaller than estimated; the results of Tarsus’ earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus’ planned clinical trials could result in increased costs, delay or limit its ability to generate revenue and adversely affect its commercial prospects; and if Tarsus is unable to obtain and maintain sufficient intellectual property protection for its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus’ competitors could develop and commercialize products similar or identical to Tarsus’ products. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statement and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2020 filed with the SEC on March 31, 2021, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Tarsus’ management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact:
SuJin Oh
Shop PR
(917) 841-5213
sujin@shop-pr.com

Investor Contact:
Patti Bank
Westwicke Partners, an ICR company
(415) 513-1284
IR@tarsusrx.com

TG Therapeutics Announces Presentation of Data from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis at 7th Congress of the European Academy of Neurology

TG Therapeutics Announces Presentation of Data from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis at 7th Congress of the European Academy of Neurology




TG Therapeutics Announces Presentation of Data from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis at 7th Congress of the European Academy of Neurology

NEW YORK, June 18, 2021 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the ULTIMATE I & II global, active controlled, Phase 3 trials evaluating ublituximab, the Company’s investigational novel, glycoengineered anti-CD20 monoclonal antibody, compared to teriflunomide, in patients with relapsing forms of multiple sclerosis (RMS), during the 7th Congress of the European Academy of Neurology (EAN). This data was previously presented at the American Academy of Neurology (AAN) 73rd Annual Meeting.

Oral Presentation Title: Ublituximab versus teriflunomide in relapsing multiple sclerosis (RMS): Results of the Phase 3 ULTIMATE I and II trials

The ULTIMATE I & II studies investigated the safety and efficacy of a one-hour 450mg infusion of ublituximab every six months, following the Day 1 infusion (150mg over four hours). The studies were conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Additionally, data from these studies are intended to support a Biologics License Application (BLA) submission for ublituximab in RMS targeted in the third quarter of 2021.

Data highlights from the ULTIMATE I & II Phase 3 studies in patients with RMS include:

Primary Endpoint: Annualized Relapse Rate (ARR) Results

  • In ULTIMATE I, treatment with ublituximab resulted in an ARR of 0.076 compared to 0.188 for teriflunomide, representing a relative reduction of approximately 60% (p<0.0001).
  • In ULTIMATE II, treatment with ublituximab resulted in an ARR of 0.091 compared to 0.178 for teriflunomide, representing a relative reduction of approximately 50% (p=0.0022).

MRI Results

  • Total number of T1 Gadolinium (Gd) enhancing lesions were reduced as a result of ublituximab treatment by 97% and 96% relative to treatment with teriflunomide in ULTIMATE I & II, respectively (p<0.0001).
  • New or enlarging T2 lesions were reduced as a result of ublituximab treatment by 92% and 90% relative to treatment with teriflunomide in ULTIMATE I & II, respectively (p<0.0001).

No Evidence of Disease Activity (NEDA) Results

  • In ULTIMATE I, 44.6% of ublituximab treated patients achieved NEDA representing a 198% improvement over teriflunomide (p <0.0001).
  • In ULTIMATE II, 43% of ublituximab treated patients achieved NEDA representing a 277% improvement over teriflunomide (p<0.0001).

Prespecified Pooled Disability Results

  • A very low rate of disability progression was observed across all treatment groups.   Only 5.2% of ublituximab treated patients showed a 12-week Confirmed Disability Progression (CDP), compared to 5.9% with teriflunomide, and only 3.3% of ublituximab treated patients showeda 24-week CDP, compared to 4.8% with teriflunomide; neither was statistically different.
  • Ublituximab treatment increased the proportion of patients with 12-week Confirmed Disability Improvement (CDI) and 24-week CDI, demonstrating a 116% increased chance in 12-week CDI (12% v. 6%; p=0.0003), and a 103% increased chance in 24-week CDI (9.6% v. 5.1%; p=0.0026) compared to teriflunomide.

Ublituximab was generally well tolerated with no unexpected safety signals. Overall, the proportion of patients in the ublituximab group with adverse events was similar to the teriflunomide group in a pooled analysis of both studies (approximately 88% in each treatment group); the most common adverse event associated with ublituximab was infusion related reactions (47.7% of patients who received ublituximab experienced at least one infusion-related reaction vs. 12.2 percent for the teriflunomide group).

ABOUT THE ULTIMATE I & II TRIALS
ULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Both studies have met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial). Ublituximab treatment resulted in an ARR of <0.10 in each of ULTIMATE I & II, with a relative reduction in ARR of approximately 60% and 50%, respectively, over teriflunomide. Key secondary MRI endpoints have also been met. Data from these studies are intended to support a Biologics License Application (BLA) submission for ublituximab in RMS targeted Q3 2021. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).

ABOUT UBLITUXIMAB
Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth or function of B-cells.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1

ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from the U.S. FDA for UKONIQ® (umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has two programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development. For more information, visit www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and Linkedin.

UKONIQ® is a trademark of TG Therapeutics, Inc.

Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such forward looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II studies and the Company’s plans and timelines for submission of a Biologics License Application (BLA) for ublituximab for the treatment of relapsing forms of Multiple Sclerosis (RMS).

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II trials that we announce or publish may change, or the perceived product profile may be impacted, as more data or additional endpoints (including efficacy and safety) are analyzed; the risk that safety issues will emerge despite our belief that there were no unexpected safety signals identified in the ULTIMATE I & II trials ; our ability to complete the BLA submission for ublituximab in RMS within the timeline projected and the risk that FDA will not accept the submission; the risk that the clinical results from the ULTIMATE I & II trials will not support regulatory approval of ublituximab to treat RMS for efficacy, safety or other issues or, if approved, that we will not receive regulatory approval within the timeline projected; the risk that if approved, ublituximab will not be commercially successful; our ability to expand our commercial infrastructure, and successfully launch, market and sell ublituximab in RMS if approved; the Company’s reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including ublituximab; the uncertainties inherent in research and development; and the risk that the ongoing COVID-19 pandemic and associated government control measures have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in our other filings with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

 
CONTACT:
 
  Investor Relations
Email: ir@tgtxinc.com 
Telephone: 1.877.575.TGTX (8489), Option 4
   
  Media Relations:
Email: media@tgtxinc.com 
Telephone: 1.877.575.TGTX (8489), Option 6

_________________________________________________________

1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.