Physician Growth Partners Announces Promotion of Robert Aprill, From Managing Director to Partner

BOSTON, MA / ACCESSWIRE / February 5, 2024 / Physician Growth Partners ("PGP"), a leading sell-side healthcare investment banking and transaction advisory firm, is pleased to announce the promotion of Robert Aprill to the position of Partner effective February 1, 2024.

Since joining PGP in January 2021 as a Managing Director, Robert has been instrumental in growing PGP’s capabilities through his experience and knowledge of the healthcare ecosystem. He was keen on driving PGP’s continued growth year-over-year, empowering Physician Growth Partners to become the lead advisor in representing physician groups in transactions with private equity. Robert has led PGP’s efforts in orthopedics, urology, oral surgery, specialty dentistry, and behavioral health, among other specialties.

"Robert’s accelerated promotion to partner is a testament to his exceptional leadership and invaluable contributions. His mentorship, commitment, and role in driving PGP’s growth has made him a leader in this organization. As a partner, Robert will continue to steer us towards new heights, bringing his expertise and dedication to help further elevate our firm’s achievements in the healthcare investment banking sector," said Michael Kroin, CEO and Managing Partner.

"As an individual I have always placed the utmost importance on aligning myself with people who share common goals and values. PGP was founded on the premise of providing a white glove approach to client service, while creating a culture of respect, loyalty, and teamwork. I am excited and honored to join PGP as a Partner and to continue working every day, strengthening our position as the premier investment bank in the healthcare sector," said Mr Aprill.

About Physician Growth Partners

Physician Growth Partners is one of the most active sell-side healthcare investment banking firms in the US and is dedicated to representing specialty physician practices in transactions with private equity. PGP creates value by providing operational support, strategic positioning, and transaction execution from start to finish. Founded in 2018, PGP has advised more than 60 practices to successful private equity partnerships.

Watch episode 27 of "Fixing Healthcare…From The Trenches", where Robert Aprill joined Dr Alejandro Badia to discuss the dynamic and consolidating healthcare landscape

For more information about Physician Growth Partners, please visit www.physiciangrowthpartners.com or contact us at press@physiciangrowthpartners.com 432 N. Clark Street, Ste. 200, Chicago, IL 60654

SOURCE: Physician Growth Partners

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Labor Smart Inc., LTNC, Next Gen Beverages Launches New eSports Division

JACKSON, WY / ACCESSWIRE / February 5, 2024 / Labor Smart, Inc. (OTC PINK:LTNC) through its wholly-owned subsidiary, Next Gen Beverages, maker of performance drink brand LOCK’DIN, is pleased to announce the launch of its new eSports Gaming Division.

The division was developed to accommodate the rapidly growing number of eSports (electronic sports) athletes taking part in multiplayer video game competitions, particularly between amateur and professional players and teams. The rapidly growing phenomenon surrounding eSports continues to gather momentum as the intersection of gaming and sports offers an innovative wave of branding opportunities, engaging content, and activations for millions across the world. The total market value for the eSports industry is estimated at over 1.6 billion. We encourage every "gamer" to visit lockdin.gg for more information and to sign up.

Quoting our Interim CEO, Tom Zarro, "I am pleased to see the gaming enthusiasts have a dedicated space to participate in their eSports competitions, enjoy our LOCK’DIN beverage products, grow their community, and do so in an environment where they’re most comfortable. It is my goal to see this division have its dedicated product line very soon, to be trademarked under another name, therefore delivering more to the parent company and the LTNC shareholder value proposition. We would love our current and potential shareholders, consumers, and gaming enthusiasts to please join our affiliate program and learn more about what’s to come. "

All current and future products feature innovative, science-based formulas, many with branded, trademarked ingredients from such respected providers as Nutrition 21 and Applied Food Sciences. One example is the LOCK’DIN Nootropic Performance Drink featuring a strategic combination of two ingredients, nooLVL® and AmaTea MAX®, which have been shown in research to improve aspects of gaming performance including memory, focus, reaction time, and information processing. These benefits not only unlock peak performance for gamers but for everyday individuals who desire improved brain performance as well.

Please direct inquiries regarding the LOCK’DIN gaming division to its dedicated director at gaming@lockdin.com.

On Tuesday, February 6th, 2024, at 8pm EST, we encourage shareholders and customers of LOCK’DIN Beverages to please join us on @lockdinnews Twitter Spacesto learn more about the ongoing developments in the company and our product line.

We encourage shareholders to register their email addresses with LOCK’DIN Beverages to stay up to date with product news and receive exclusive shareholder-only promotions. Sign up at https://lockdin.com/pages/shareholder-opt-in.

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of the U.S. federal securities laws, which statements may include information regarding the plans, intentions, expectations, future financial performance, or future operating performance of Labor Smart, Inc. ("Labor Smart" or the "Company"). Forward-looking statements are based on the expectations, estimates, or projections of the Company’s management as of the date of this press release. Although Labor Smart’s management believes these expectations, estimates, or projections to be reasonable as of the date of this presentation, forward-looking statements are inherently subject to significant business risks, economic and competitive uncertainties, or other contingencies, which could cause the Company’s actual results or performance to differ materially from what may be expressed or implied in the forward-looking statements. Important factors that could cause Labor Smart’s actual results or performance to differ materially from the forward-looking statements include those set forth in the "Risk Factors" sections in the Company’s filings with the Securities and Exchange Commission, which are available for viewing on the SEC’s EDGAR website. These forward-looking statements speak only as of the date of this press release and, except as required by law, Labor Smart specifically disclaims any obligation to update these forward-looking statements, even if new information becomes available in the future.

Tom Zarro, Interim CEO and Board Member
Mailing Address
P.O. Box 2922
Jackson, WY 83001-2922
customerservice@lockdin.com
844-562-5246
www.lockdin.com

SOURCE: Labor Smart, Inc.

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PureCycle Provides Notice of Agreement in Principle to Purchase Ironton Bonds

ORLANDO, FL / ACCESSWIRE / February 5, 2024 / PureCycle Technologies, Inc. (Nasdaq:PCT) (the "Company"), today announced that PureCycle: Ohio LLC ("PCO"), an indirect subsidiary of the Company, has reached an agreement in principle with holders of a majority (the "Majority Holders") of the Southern Ohio Port Authority Exempt Facility Revenue Bonds (PureCycle Project), Tax-Exempt Series 2020A (the "Series 2020A Bonds"), of which $219,550,000 principal amount is outstanding, to purchase for cash (the "Purchase"), at a purchase price equal to $1,030 per $1,000 principal amount of Bonds (as defined below) purchased (the "Purchase Price"). In addition to the Majority Holders, additional holders of the Series 2020A Bonds may participate in the Purchase.

Holders of the Series 2020A Bonds that participate in the Purchase will be required to consent (each a "Consent" and collectively, the "Consents") to certain proposed amendments (the "Proposed Amendments") to the bond documents governing the Series 2020A Bonds and closing of the Purchase will require that no less than Majority Holders participate in the Purchase and provide their Consents. The Proposed Amendments will eliminate certain restrictive covenants and events of default contained in the bond documents governing the Series 2020A Bonds that are permitted to be eliminated with the consent of the Majority Holders. The Consents will become effective upon closing of the Purchase.

In addition to the Purchase of the Series 2020A Bonds, PCO may purchase Southern Ohio Port Authority Subordinate Exempt Facility Revenue Bonds (PureCycle Project), Tax-Exempt Series 2020B (the "Series 2020B Bonds"), of which $20,000,000 principal amount is outstanding, and Southern Ohio Port Authority Subordinate Exempt Facility Revenue Bonds (PureCycle Project), Taxable Series 2020C (the "Series 2020C Bonds"), of which $10,000,000 principal amount is outstanding (the Series 2020A Bonds, Series 2020B Bonds and Series 2020C Bonds collectively, the "Bonds," and the holders thereof, the "Holders"), for which Consents shall also be required to the extent such Bonds are purchased.

The Purchase Price is calculated in part to compensate the Sellers for default interest accruing from January 2, 2023 through December 31, 2023, and any other accrued and unpaid interest on the Bonds from, and including, the most recent interest payment date up to the closing date of the Purchase. The Purchase Price does not include any default or penalty interest accruing from January 1, 2024, that may otherwise be owed and Holders that participate in the Purchase will waive their respective right to such default or penalty interest.

The Proposed Amendments to the Indenture of Trust, dated as of October 1, 2020 (as amended, restated, supplemented or otherwise modified from time to time, the "Indenture"), between Southern Ohio Port Authority (the "Issuer") and UMB Bank, N.A., as trustee ("Trustee") and the Loan Agreement by and between the Issuer and PCO, dated as of October 1, 2020 (as amended, restated, supplemented or otherwise modified from time to time, the "Loan Agreement") are expected to include, but are not limited to, the following:

  • Elimination of certain restrictive covenants and events of default contained in the Indenture and the Loan Agreement and other transaction documents that are permitted to be eliminated with the consent of the Majority Holders; and
  • Release of funds (solely to the extent such release may be effectuated with the consent of the Majority Holders) on deposit in accounts in the Trust Estate (as defined in the Indenture) in an amount proportionate to the percentage of the aggregate principal amount of the Bonds that Sellers submit for Purchase, which released funds will be used by PCO to effectuate the Purchase.

The Purchase is intended to allow the Company to provide additional flexibility in completing commissioning activities at the Ironton Facility. The Company expects to fund the Purchase with those Trust Estate funds released under the Proposed Amendments together with available cash on hand.

The Purchase will not occur unless the Majority Holders participate in the Purchase and provide Consents to the Proposed Amendments. The Purchase is expected to close no later than February 15, 2024.

None of the Company or its affiliates, their respective boards of directors, or the Trustee is making any recommendation as to whether Holders should participate in the Purchase, and neither the Company nor any such other person has authorized any person to make any such recommendation. Holders must make their own decisions as to whether to sell any Bonds and the principal amount of Bonds to sell.

This news release shall not constitute an offer to sell, a solicitation to buy or an offer to purchase or sell any securities. The offer is being made only pursuant to a definitive purchase agreement between PCO and the participating Holders and only in such jurisdictions where permitted under applicable law.

###

PureCycle Contact

Christian Bruey
cbruey@purecycle.com
+1 (352) 745-6120

About PureCycle Technologies

PureCycle Technologies LLC., a subsidiary of PureCycle Technologies, Inc., holds a global license for the only patented solvent-driven purification recycling technology, developed by The Procter & Gamble Company (P&G), that is designed to transform polypropylene plastic waste (designated as No. 5 plastic) into a continuously renewable resource. The unique purification process removes color, odor, and other impurities from No. 5 plastic waste resulting in an ultra-pure recycled (UPR) plastic that can be recycled and reused multiple times, changing our relationship with plastic. www.purecycle.com

Forward-Looking Statements

This press release contains forward-looking statements, including statements about the outcome of any legal proceedings to which PureCycle is, or may become a party, and the financial condition, results of operations, earnings outlook and prospects of PureCycle. Forward-looking statements generally relate to future events or PureCycle’s future financial or operating performance and may refer to projections and forecasts. Forward-looking statements are often identified by future or conditional words such as "plan," "believe," "expect," "anticipate," "intend," "outlook," "estimate," "forecast," "project," "continue," "could," "may," "might," "possible," "potential," "predict," "should," "would" and other similar words and expressions (or the negative versions of such words or expressions), but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements are based on the current expectations of the management of PureCycle and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of this press release. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in the section entitled "Risk Factors" in each of PureCycle’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and PureCycle’s Quarterly Reports on Form 10-Q, those discussed and identified in other public filings made with the Securities and Exchange Commission by PureCycle and the following:

• PCT’s ability to obtain funding for its operations and future growth and to continue as a going concern;

• PCT’s ability to meet, and to continue to meet, applicable regulatory requirements for the use of PCT’s UPR resin (as defined below) in food grade applications (including in the United States, Europe, Asia and other future international locations);

• PCT’s ability to comply on an ongoing basis with the numerous regulatory requirements applicable to the UPR resin and PCT’s facilities (including in the United States, Europe, Asia and other future international locations);

• expectations and changes regarding PCT’s strategies and future financial performance, including its future business plans, expansion plans or objectives, prospective performance and opportunities and competitors, revenues, products and services, pricing, operating expenses, market trends, liquidity, cash flows and uses of cash, capital expenditures, and PCT’s ability to invest in growth initiatives;

• the ability of PCT’s first commercial-scale recycling facility in Lawrence County, Ohio (the "Ironton Facility") to be appropriately certified by Leidos, following certain performance and other tests, and commence full-scale commercial operations in a timely and cost-effective manner;

• PCT’s ability to meet, and to continue to meet, the requirements imposed upon it and its subsidiaries by the funding for its operations, including the funding for the Ironton Facility;

• PCT’s ability to complete the necessary funding with respect to, and complete the construction of, (i) its first U.S. multi-line facility, located in Augusta, Georgia (the "Augusta Facility"); (ii) its first commercial-scale European plant located in Antwerp, Belgium and (iii) its first commercial-scale Asian plant located in Ulsan, South Korea, in a timely and cost-effective manner;

• PCT’s ability to sort and process polypropylene plastic waste at its plastic waste prep ("Feed PreP") facilities;

• PCT’s ability to maintain exclusivity under the Procter & Gamble Company ("P&G") license (as described below);

• the implementation, market acceptance and success of PCT’s business model and growth strategy;

• the success or profitability of PCT’s offtake arrangements;

• the ability to source feedstock with a high polypropylene content at a reasonable cost;

• PCT’s future capital requirements and sources and uses of cash;

• developments and projections relating to PCT’s competitors and industry;

• the outcome of any legal or regulatory proceedings to which PCT is, or may become, a party including the securities class action case;

• geopolitical risk and changes in applicable laws or regulations;

• the possibility that PCT may be adversely affected by other economic, business, and/or competitive factors, including rising interest rates, availability of capital, economic cycles, and other macro-economic impacts;

• turnover or increases in employees and employee-related costs;

• changes in the prices and availability of labor (including labor shortages), transportation and materials, including significant inflation, supply chain conditions and its related impact on energy and raw materials, and PCT’s ability to obtain them in a timely and cost-effective manner;

• any business disruptions due to political or economic instability, pandemics, armed hostilities (including the ongoing conflict between Russia and Ukraine and the current situation in Israel);

• the potential impact of climate change on PCT, including physical and transition risks, higher regulatory and compliance costs, reputational risks, and availability of capital on attractive terms; and operational risk.

SOURCE: PureCycle Technologies, Inc.

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Innodata to Participate in A.G.P.’s Virtual Technology Conference

NEW YORK, NY / ACCESSWIRE / February 5, 2024 / INNODATA INC. (NASDAQ:INOD) a leading data engineering company, announced that it will be participating in the Alliance Global Partners (A.G.P.) Virtual Technology Conference on February 7, 2024.

Jack Abuhoff, CEO, will be hosting one-on-one meetings. Innodata’s investor presentation is available at innodata.com/investor-relations/.

Alliance Global Partners (www.allianceg.com) is a global investment and advisory firm based in New York City.

Investors who wish to request a meeting with Innodata should contact their A.G.P. representative or reach out to Marcia Novero, company contact, at mnovero@innodata.com.

About Innodata

Innodata (NASDAQ:INOD) is a global data engineering company delivering the promise of AI to many of the world’s most prestigious companies. We provide AI-enabled software platforms and managed services for AI data collection/annotation, AI digital transformation, and industry-specific business processes. Our low-code Innodata AI technology platform is at the core of our offerings. In every relationship, we honor our 30+ year legacy delivering the highest quality data and outstanding service to our customers. Visit www.innodata.com to learn more.

Forward Looking Statements

This press release may contain certain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These forward-looking statements include, without limitation, statements concerning our operations, economic performance, and financial condition. Words such as "project," "believe," "expect," "can," "continue," "could," "intend," "may," "should," "will," "anticipate," "indicate," "predict," "likely," "estimate," "plan," "potential," "possible," "promises," or the negatives thereof, and other similar expressions generally identify forward-looking statements.

These forward-looking statements are based on management’s current expectations, assumptions and estimates and are subject to a number of risks and uncertainties, including, without limitation, impacts resulting from the continuing conflict between Russia and the Ukraine and Hamas’ attack against Israel and the ensuing conflict; investments in large language models; that contracts may be terminated by customers; projected or committed volumes of work may not materialize; pipeline opportunities and customer discussions which may not materialize into work or expected volumes of work; the likelihood of continued development of the markets, particularly new and emerging markets, that our services support; the ability and willingness of our customers and prospective customers to execute business plans that give rise to requirements for our services; continuing reliance on project-based work in the Digital Data Solutions (DDS) segment and the primarily at-will nature of such contracts and the ability of these customers to reduce, delay or cancel projects; potential inability to replace projects that are completed, canceled or reduced; continuing DDS segment revenue concentration in a limited number of customers; our dependency on content providers in our Agility segment; difficulty in integrating and deriving synergies from acquisitions, joint ventures and strategic investments; potential undiscovered liabilities of companies and businesses that we may acquire; potential impairment of the carrying value of goodwill and other acquired intangible assets of companies and businesses that we acquire; a continued downturn in or depressed market conditions; changes in external market factors; changes in our business or growth strategy; the emergence of new, or growth in existing competitors; various other competitive and technological factors; our use of and reliance on information technology systems, including potential security breaches, cyber-attacks, privacy breaches or data breaches that result in the unauthorized disclosure of consumer, customer, employee or Company information, or service interruptions and other risks and uncertainties indicated from time to time in our filings with the Securities and Exchange Commission.

Our actual results could differ materially from the results referred to in forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the risks discussed in Part I, Item 1A. "Risk Factors," Part II, Item 7. "Management’s Discussion and Analysis of Financial Condition and Results of Operations," and other parts of our Annual Report on Form 10-K, filed with the Securities and Exchange Commission on February 24, 2023, as updated or amended by our other filings that we may make with the Securities and Exchange Commission. In light of these risks and uncertainties, there can be no assurance that the results referred to in the forward-looking statements will occur, and you should not place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof.

We undertake no obligation to update or review any guidance or other forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required by the Federal securities laws.

Company Contact

Marcia Novero
Innodata Inc.
Mnovero@innodata.com
(201) 371-8015

SOURCE: Innodata Inc.

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Here to Serve Holding Corp. Completes Company Name Change to Mesa Home Resources, Inc., Under the New Trading Symbol “MHRE”

ANAHEIM, CA / ACCESSWIRE / February 5, 2024 / Mesa Home Resources, Inc. (OTC PINK:MHRE) ("Mesa" or the "Company") is the new corporate name and ticker symbol of Here To Serve Holding Corp. (OTC PINK:HTSC).

Effective February 5, 2024. the Company will be officially known as Mesa Home Resources, Inc., and its new trading symbol will be MHRE. The change reflects the Company’s commitment to its new strategic direction and aligns with recent transformative developments.

The Company recently completed its acquisition of DCE Construction, Inc., dba Mesa Garage Doors, marking a pivotal moment in the Company’s growth trajectory. The acquisition, which closed on November 3, 2023, positioned the Company as a leader in the home improvement sector, focusing on garage doors, entry doors, and custom gates.

Dwight Esnard, CEO of Mesa Home Resources, Inc., expressed enthusiasm for the achievement, stating "The completion of the acquisition and related transactions are pivotal milestones for our growth. We believe that we are now well-positioned to harness the vast opportunities presented in the home improvement industry."

Michael Layman, CFO of Mesa Home Resources, Inc., added "The strategic decisions taken by Mesa Home Resources, Inc. pave the way for exciting prospects in the home improvement sector. We are committed to driving financial success."

About Mesa Home Resources, Inc.
Mesa Home Resources, Inc. (OTC PINK:MHRE) was founded over 30 years ago, and is a Southern California leader in the otherwise highly fragmented business of sales, installation, and service for garage doors. Over these 30 years, Mesa has serviced well over half of a million customers, utilizing its own staff of installers, technicians, and repair employees. With a strong reputation and extensive customer base, Mesa has leveraged its financial strength, scalability, operations and service call center, and professional management to become one of the largest garage door specialty companies in the United States. (www.mesagaragedoors.com)

Safe Harbor Statement
This release contains "forward-looking statements." Forward-looking statements also may be included in other publicly available documents issued by Mesa Home Resources, Inc. and in oral statements made by our officers and representatives from time to time. These forward-looking statements are intended to provide management’s current expectations or plans for our future operating and financial performance, based on assumptions currently believed to be valid. They can be identified by the use of words such as "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "would," "could," and other words of similar meaning in connection with a discussion of future operating or financial performance.

Examples of forward-looking statements include, among others, statements relating to the Company’s ability to successfully integrate the Mesa business, the development of the Company post-closing, future sales, earnings, cash flows, results of operations, uses of cash, and other measures of financial performance.

Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and other factors that may cause Mesa Home Resources, Inc.’s actual results and financial condition to differ materially from those expressed or implied in the forward-looking statements. Such risks, uncertainties and other factors include, among others such as, but are not limited to economic conditions, changes in the laws or regulations, demand for Mesa Home Resources, Inc.’s products and services, the effects of competition, and other factors that could cause actual results to differ materially from those projected or represented in the forward-looking statements. Any forward-looking information provided in this release should be considered with these factors in mind. We assume no obligation to update any forward-looking statements contained in this press release.

Company Contact:
For more information about Mesa Home Resources, Inc. please contact:
info@mesagaragedoors.com
(714) 560-7270
www.mesagaragedoors.com

SOURCE: Mesa Home Resources, Inc.

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Tharimmune Announces Dosing of First Patient in Phase 1 Clinical Trial of TH104, its Lead Candidate for Pruritus in Primary Biliary Cholangitis

Phase 1 clinical trial dosing of first patient complete; primary objective to assess safety/tolerability and absolute bioavailability of TH104

Phase 1 study expected to be completed in 1Q24 with topline readout in 2Q24

Company fully funded into 2025 with full readouts of Phase 1 and 2 in moderate-to-severe chronic pruritus in PBC expected in 4Q24/1Q25

BRIDGEWATER, NJ / ACCESSWIRE / February 5, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation & immunology announced today the first patient dosed in the Company’s Phase 1 clinical trial with TH104, utilizing a proprietary oral thin film. TH104 is a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene onto a thin film which easily adheres inside of the mouth on the cheek and biodegrades within minutes.

Tharimmune’s lead clinical-stage asset, TH104, is designed as an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions, by avoiding the first-pass metabolism usually in traditional oral formulations. The molecule has a dual mechanism of action affecting both the mu and kappa opioid receptors, while emerging data suggests inhibition of interleukin-17, a pro-inflammatory cytokine. The well-known mu and kappa receptors, when stimulated and/or inhibited by the body’s endogenous ligands, have been implicated in the body’s itch circuitry for certain conditions, specifically cholestatic or dysregulated bile acid-related liver conditions.

The Phase 1 clinical trial currently recruiting is a pharmacokinetic bridging study in the U.S. designed as a single-dose, single-center, open-label, randomized 2-way crossover study of TH104 and an intravenous dose of nalmefene administered under fasting conditions, with a 7-day washout period between doses. Sixteen normal healthy volunteers are anticipated to participate and complete the study. The primary objective is to evaluate the absolute bioavailability of TH104 as well as assess safety and tolerability. Topline data is expected in 2Q24 with a full data readout shortly thereafter.

"The dosing of the first patient in our Phase 1 study of TH104 marks the initiation of our vision of becoming a patient-focused clinical development organization," said Randy Milby, Chief Executive Officer of Tharimmune. "Along with the recently disclosed human studies conducted outside the US, and a focused effort to complete this ongoing trial, we are dedicated to advance TH104, which has the potential to bring meaningful patient benefit. We aim to continue our momentum in the clinic and remain on-track to initiate a Phase 2 program this year."

Primary biliary cholangitis (PBC) is a chronic cholestatic autoimmune disease with debilitating symptoms, including pruritus or "unrelenting itching" and fatigue. Pruritus is a common clinical feature seen in liver diseases but particularly frequent in cholestatic liver disease. A recent study found that pruritus in PBC is under-treated in clinical practice in the United States. Current treatment options may only be partially effective or poorly tolerated and are not FDA-approved for cholestatic pruritus in patients with PBC, therefore effective solutions for this significant problem are a high unmet need.

Multiple ex-US human studies have been completed with TH104 which showed reliable and predictable delivery of nalmefene in healthy subjects using our proprietary drug embedded transmucosal oral film applied to the inside of the cheek. Another previously disclosed study of an open-label trial using TH104 in chronic liver disease patients showed a 33.3% decline in 24-hour itch intensity when administered a single low-dose. Safety and tolerability in these studies were consistent with published studies in the literature with nalmefene, the active ingredient in TH104.

The Company previously announced the closing of an $11 million public offering which it believes is sufficient to extend its cash runway into early 2025 for both clinical readouts of its lead program, TH104. Tharimmune plans to advance both its clinical and non-clinical programs and announce an R&D Day in 2Q24 to update stakeholders and patients.

About TH104

TH104 is embedded with nalmefene onto a proprietary transdermal buccal film which easily adheres to the inside of the mouth. This endows TH104 with key features making it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action affecting both the µ-opioid receptor and the kappa opioid receptor as well as inhibiting IL-17 inflammatory cytokine expression. These opioid receptors when stimulated and/or inhibited by the body’s natural ligands have been known to be involved in the body’s itch circuitry.

About Pruritus and Primary Biliary Cholangitis

According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, PBC, is a chronic disease where the bile ducts in the liver eventually become dysfunctional and cause the buildup of bile which causes liver damage. The disease, believed to be an autoimmune condition, affects an estimated 58 out of every 100,000 U.S. women and about 15 out of every 100,000 U.S. men. Pruritus is one of the most common symptoms associated with PBC affecting up to 75% of individuals at some point during their disease course. It has a negative impact on health-related quality of life with limited treatment options. Published survey data of PBC respondents suffering from pruritus described their itch as "bugs crawling under the skin". More than 65% of patients reported that the itch was worse at night, known as nocturnal pruritus, a high unmet need.

About Tharimmune

Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. The Company’s lead clinical-stage asset, TH104 is known to suppress chronic, debilitating pruritus or "uncontrollable itching" in PBC, a rare and orphan liver disease with no known cure. The Company’s early-stage immunology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors, including PD-1, HER2 and HER3. Tharimmune has a license agreement with OmniAb, Inc. to access the company’s antibody discovery technology platform against these and other specified targets. For more information please visit: www.tharimmune.com.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding Tharimmune’s strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K/A for the year ended December 31, 2022 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. Subsequent events and developments may cause the Company’s views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.

Investor Relations Contact

ir@tharimmune.com
www.tharimmune.com

SOURCE: Tharimmune, Inc.

View the original press release on accesswire.com