Market Newsdesk

NEW YORK, May 12, 2026 (GLOBE NEWSWIRE) — E.F. Hutton & Co. (“E.F. Hutton”), an investment banking and financial advisory firm headquartered in New York City, today announced that it acted as the exclusive placement agent in connection with a $2.5 million private placement for iSpecimen Inc. (Nasdaq: ISPC) (“iSpecimen” or the “Company”), an online global marketplace that connects scientists requiring biospecimens for medical research with a network of healthcare specimen providers.

This transaction represents E.F. Hutton’s latest financing completed with iSpecimen. In December 2025, E.F. Hutton also acted as the exclusive placement agent in connection with a separate private placement for the Company, which raised approximately $5.5 million in gross proceeds. A demonstration of E.F. Hutton’s continued ability to execute strategic capital markets transactions and support growth-oriented companies across the healthcare and life sciences sectors.

Joseph T. Rallo, Chief Executive Officer of E.F. Hutton & Co., commented, “We are pleased to have advised iSpecimen on this successful financing. iSpecimen has established a differentiated and scalable platform that plays an important role in advancing medical research by improving access to high-quality human biospecimens for the scientific community. The Company’s innovative marketplace model and growing network of healthcare partners position it well to support the evolving needs of researchers and commercial organizations worldwide. We are proud to support iSpecimen as it continues to execute on its strategic growth initiatives and expand its impact across the medical discovery ecosystem.”

The offering closed on May 11, 2026. iSpecimen intends to use the net proceeds from the offering for working capital and general corporate purposes.

About E.F. Hutton & Co.

E.F. Hutton & Co. is an investment bank and broker-dealer headquartered in Manhattan, providing comprehensive advisory and financing solutions to a diverse range of clients including corporates, sponsors, and public-private partnerships. With a global footprint, we offer end-to-end investment banking services encompassing capital markets, PIPEs, private placements, M&A advisory, and strategic financing. The Executive Team at E.F. Hutton & Co. has a proven track record of delivering unwavering strategic advice to clients across the U.S., Asia, Europe, the UAE, and Latin America.

Contact Information

E.F. Hutton & Co.
[email protected]
https://efhutton.com
(212) 970-3700

NEWARK, N.J., May 12, 2026 (GLOBE NEWSWIRE) —
BOSS Money, the international money remittance service of IDT Corporation (NYSE: IDT), today announced that its customers sent moms a record amount of principal and remittances using the BOSS Money and BOSS Revolution apps during the week leading up to and including Mother’s Day on May 10^th, 2026.

For the week ended May 10^th, 2026, BOSS Money digital customers sent 49% more principal via 27% more remittances than last year to the eight BOSS Money destination countries that celebrated Mother’s Day this past weekend, including Mexico, Guatemala, Honduras and El Salvador.

BOSS Money is a leading digital-first money remittance provider. 87% of all BOSS Money transfers during the week leading up to Mother’s Day were originated by customers using the trusted BOSS Money and BOSS Revolution apps.

“We are honored that so many new and returning customers entrusted BOSS Money to deliver their hard-earned money to mom this Mother’s Day,” said Michelle Rendo, BOSS Money’s VP of Marketing. “It is our privilege to help bring families closer together on mom’s special day.”

BOSS Money’s international remittance service provides affordable, reliable money transfers for residents of the U.S. to 50 popular destination countries in Latin America, the Caribbean, Africa, and South Asia.

In its most recent rankings, FXC Intelligence recognized BOSS Money as the top-rated money transfer app, with a near-perfect 4.9 rating. Across the Apple App Store and Google Play, BOSS Money has over 110,000 five-star reviews.

See a Spanish language sample of BOSS Money Mother’s Day campaign here.

Download the BOSS Money app on iOS or Android or visit bossmoney.com.

Stay connected and follow BOSS Money on Instagram, Facebook and TikTok @bossmoney.official.  

*The rates of increase in principal and transactions for Mother’s Day 2026 compare the seven days leading up to and including Mother’s Day 2026 (May 4

^th

to 10

^th

) to the comparable week in 2025 (May 5

^th

to 11

^th

). For ‘destination countries that celebrated Mother’s Day,’ the rates of increase reflect transfers originated in the U.S. to the 8 destination countries served by BOSS Money that celebrated Mother’s Day during the weeks ended Sunday, May 10

^th

, 2026, and Sunday, May 11

^th

, 2025.

ABOUT



BOSS MONEY



BOSS Money’s rapidly expanding international remittance service provides fast, secure and reliable money transfers for residents of the U.S. to popular destination countries in Latin America, the Caribbean, Africa, and South Asia. BOSS Money offers a robust menu of payout options, including bank deposits, cash pick-up, mobile wallets, direct-to-debit, and home delivery. Customers can remit funds through the highly rated BOSS Money and BOSS Revolution apps, WhatsApp or through licensed BOSS Money retailers. BOSSMoney is the remittance and payments brand of IDT Corporation (NYSE: IDT).

ABOUT IDT CORPORATION



IDT Corporation
(NYSE: IDT) is a global provider of fintech and communications services through a portfolio of synergistic businesses: National Retail Solutions (NRS), through its point-of-sale (POS) platform, enables independent retailers to operate more effectively while providing advertisers and marketers with unprecedented reach into underserved consumer markets; net2phone provides enterprises and organizations with intelligently integrated cloud communications and contact center services across channels and devices; IDT’s fintech and neo-banking services include BOSS Money, a popular international remittance business, as well as other services that make saving, spending, and sharing money easy and secure; IDT Digital Payments and BOSS Revolution Calling make sharing prepaid products and services and speaking with friends and family around the world convenient and reliable; and, IDT Global and IDT Express enable communications services to provision and manage international voice and SMS messaging.

All statements above that are not purely about historical facts, including, but not limited to, those in which we use the words “believe,” “anticipate,” “expect,” “plan,” “intend,” “estimate,” “target” and similar expressions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. While these forward-looking statements represent our current judgment of what may happen in the future, actual results may differ materially from the results expressed or implied by these statements due to numerous important factors. Our filings with the SEC provide detailed information on such statements and risks and should be consulted along with this release. To the extent permitted under applicable law, IDT assumes no obligation to update any forward-looking statements.

Contact



:


Bill Ulrey
IDT Investor Relations
Phone: (973) 438-3838
E-mail: [email protected]

# # #

FDA filing covers renewal applications for VLN^® King and VLN^® Menthol King, the first combusted cigarettes authorized as Modified Risk Tobacco Products, as 22nd Century advances its regulatory pathway for continued modified risk marketing status

MOCKSVILLE, N.C., May 12, 2026 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco harm reduction company focused on reduced nicotine innovation, today highlighted that the U.S. Food and Drug Administration has filed for scientific review two Modified Risk Tobacco Product, or MRTP, renewal applications for the Company’s VLN^® King and VLN^® Menthol King combusted, filtered cigarettes. The FDA filing marks an important step in the regulatory process for the continued marketing of these products with authorized modified risk claims.

VLN^® King and VLN^® Menthol King were originally granted MRTP exposure modification orders by the FDA in December 2021, making them the first combusted cigarettes ever authorized as MRTPs. Those orders are set to expire in December 2026 unless renewed, and the current review process is intended to support continued modified risk marketing status beyond that date.

“We are pleased that the FDA has filed our VLN^® MRTP renewal applications for scientific review, an important procedural step in the renewal process for the first and only combustible cigarettes authorized as modified risk tobacco products,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “We believe this development reflects the strength of the scientific and regulatory foundation supporting VLN^®, and we remain focused on working through the FDA review process responsibly, transparently and in full compliance with all applicable requirements as we continue advancing our reduced-nicotine platform for adult smokers.”

Under the existing FDA orders, 22nd Century is authorized to market VLN^® King and VLN^® Menthol King with specific reduced-exposure nicotine claims, including “95% less nicotine,” “Helps reduce your nicotine consumption,” and “…Greatly reduces your nicotine consumption,” provided those claims are accompanied by the statement “Helps you smoke less.” The Company believes the continued review of these products is strategically important because VLN^® remains a uniquely differentiated product platform within the combustible tobacco category.

In connection with the renewal process, the FDA has begun releasing redacted application materials for public access and opened a docket for public comment, enabling stakeholders to submit data and feedback as part of the scientific review. 22nd Century believes this process further underscores the rigor of the FDA’s modified risk framework and the significance of maintaining a robust evidence base for its VLN^® franchise.

In its original MRTP review, the FDA found that nicotine levels in the tobacco and mainstream smoke of VLN cigarettes are at least 95% lower than the majority of marketed and market-leading conventional cigarette brands. The agency also stated that consumers who exclusively use cigarettes with the same or similarly reduced nicotine content as VLN cigarettes could reduce their nicotine exposure by approximately 95%, and that use of these products is reasonably likely to reduce nicotine dependence.

22nd Century previously announced that its renewal submission was supported by additional marketplace data, including a 2024 study involving more than 400 participants, which the Company said demonstrated a 40% reduction in daily cigarette consumption over 12 weeks among smokers using VLN^® cigarettes. The Company believes this data strengthens the long-term commercial and regulatory case for the VLN^® platform, although the outcome and timing of the FDA’s renewal review remain subject to the agency’s independent evaluation.

This release does not announce renewal approval, and no assurance can be given regarding the outcome of the FDA’s review. The original publication can be found on the FDA website here:https://www.fda.gov/tobacco-products/advertising-and-promotion/22nd-century-group-inc-modified-risk-tobacco-product-mrtp-applications?utm_campaign=ctp-mrtp&utm_content=landingpage&utm_medium=email&utm_source=govdelivery&utm_term=stratcomms

About 22nd Century Group, Inc. 

22nd Century Group is pioneering the Tobacco Harm Reduction and Nicotine Reduction Movements by enabling smokers to take control of their nicotine consumption. 

Our Technology is Tobacco

Our proprietary non-GMO reduced nicotine tobacco plants were developed using our patented technologies that regulate alkaloid biosynthesis activities resulting in a tobacco plant that contains 95% less nicotine than traditional tobacco plants. Our extensive patent portfolio has been developed to ensure that our-high-quality tobacco can be grown commercially at scale. We continue to develop our intellectual property to ensure our ongoing leadership in the tobacco harm reduction movement. 

Our Products 

We created our flagship product, the VLN^® cigarette using our low nicotine tobacco, to give traditional cigarette smokers an authentic and familiar alternative in the form of a combustible cigarette that helps them take control of their nicotine consumption. VLN^® cigarettes have 95% less nicotine compared to traditional cigarettes and have been proven to allow consumers to greatly reduce their nicotine consumption.

VLN^® and Helps You Smoke Less^® are registered trademarks of 22nd Century Limited LLC.

Learn more at xxiicentury.com, on X (formerly Twitter), on LinkedIn, and on YouTube.

Learn more about VLN^® at tryvln.com.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements, including but not limited to our full year business outlook. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Forward-looking statements include, but are not limited to, statements regarding (i) our expectations regarding regulatory enforcement, including our ability to receive authorization or approval for new products, and (ii) our financial and operating performance. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 26, 2026. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact

Matt Kreps
Investor Relations
22nd Century Group
[email protected]
214-597-8200

• CBeyond™ Expansion Study (Part C) initiated; Cohort Review Committee review scheduled for May 18, 2026, to evaluate available safety data and potential progression to Cohort 2
  
  

SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) — Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye” or the “Company”), a clinical stage biotechnology company developing next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the first quarter ended March 31, 2026, along with recent business updates and anticipated milestones.

“Since our March update, execution has focused on turning CBeyond into a Phase 2b-ready development program,” said Punit Dhillon, President & CEO of Skye. “We have now initiated enrollment of Cohort 1 of the CBeyond Expansion Study, executed the compatibility and in-use study with ENHANZE to support a practical high-volume subcutaneous approach, and engaged external development advisors to help pressure-test our target product profile, dose-selection rationale and Phase 2b trial design. Our objective in 2026 remains focused on defining the dose and exposure that can support a larger Phase 2b study evaluating nimacimab as a complementary add-on approach for GLP-1-experienced patients.”

Business and Clinical Highlights

CBeyond™


 Expansion Study (Part C)

• Cohort 1 is designed to evaluate nimacimab 400 mg IV (equivalent to ~700 mg SC) once weekly versus matched placebo, randomized 3:1, over a 16-week treatment period followed by 12 weeks of follow-up.
• The Cohort Review Committee (CRC) is scheduled to meet on May 18, 2026 to review available Cohort 1 safety data and determine whether safe-to-proceed criteria have been met to initiate enrollment in Cohort 2.
• Cohort 2 is designed to evaluate nimacimab 600 mg IV (equivalent to ~1000 mg SC) once weekly versus matched placebo, randomized 3:1, over the same treatment and follow-up period.
• Skye continues to expect topline clinical data from the CBeyond Expansion Study in Q4 2026. The study is designed to generate higher-exposure human safety and pharmacokinetic data to inform dose selection for a planned Phase 2b study.

Q1 Accomplishments

• Skye has completed all previously announced clinical milestones for Q1: reported CBeyond interim extension data, received FDA Type C meeting minutes, launched the CBeyond Expansion Study (Part C), and completed a compatibility and in-use stability study with ENHANZE.
• The Company remains on track to complete the Q2 2026 catalyst set, including initiation of Cohort 2 enrollment, pending receipt of the CRC’s determination that safe-to-proceed criteria have been met, completion of enrollment across Cohorts 1 and 2, presentation or disclosure of additional preclinical bioconjugation data, and completion of feasibility work for the high-concentration nimacimab program.

Clinical Data Foundation Supporting the Current Development Strategy

• In previously reported CBeyond data, nimacimab plus semaglutide demonstrated an approximately 3% incremental weight-loss benefit versus semaglutide alone at 26 weeks, with statistically significant improvements in waist circumference and lean-to-fat mass ratio.
• In the previously reported interim 52-week combination update, participants receiving nimacimab 200 mg plus semaglutide 2.4 mg achieved 22.3% mean weight loss, with no plateau observed at the time of analysis.
• At the tested dose, nimacimab demonstrated a favorable tolerability profile, with no nimacimab-associated neuropsychiatric safety signal observed and no additive gastrointestinal adverse-event burden when combined with semaglutide.
• During off-therapy follow-up, the nimacimab plus semaglutide cohort demonstrated lower weight regain than the semaglutide-alone cohort, and available body-composition data suggested maintenance of fat-mass loss and improvement in lean-to-fat mass ratio during follow-up.
• Skye believes these findings support development of nimacimab as complementary to, rather than competitive with, incretin therapies, particularly for GLP-1-experienced patients who plateau, require additional weight loss, are titration-limited, or need more durable metabolic control.

Phase 2b Planning

• Skye has received written FDA Type C meeting minutes and is incorporating feedback into ongoing Phase 2b planning, including dose, duration, endpoints, inclusion/exclusion criteria and a defined indication and patient population for nimacimab as an add-on therapy to incretins.
• Skye has engaged Lilly Catalyze360-ExploR&D in a development consulting engagement to provide written feedback on the nimacimab target product profile, and Phase 2b trial architecture.
• This engagement is a development advisory engagement and does not constitute a commitment regarding any future transaction, therapeutic interest, exclusivity or corporate business development process.

CMC and Drug Delivery Strategy

• Skye has executed the compatibility and in-use study with Halozyme’s ENHANZE® (rHuPH20) technology to support a planned site-based “mix-and-deliver” approach for high-volume subcutaneous administration of nimacimab in future clinical development.
• Co-formulation with ENHANZE is intended to support practical subcutaneous delivery of higher nimacimab doses.
• Skye continues feasibility work on a high-concentration nimacimab formulation, with the objective of reducing injection volume and supporting patient-friendly subcutaneous administration across potential dose levels.
• Skye continues to evaluate manufacturing process improvements, supply-chain options and cost-of-goods levers to support late-stage development and potential commercial scalability if nimacimab is approved.

Upcoming Anticipated Milestones

• Q2 2026: Cohort Review Committee review of available Cohort 1 safety data and potential initiation of Cohort 2 enrollment.
• Q2 2026: Complete enrollment across CBeyond Expansion Study Cohorts 1 and 2.
• Q2 2026: Complete feasibility work for the high-concentration nimacimab formulation program.
• Q4 2026: Report topline clinical data from the CBeyond Expansion Study.
• Q4 2026: Finalize planned Phase 2b study design, including dose-selection rationale, protocol architecture and operational readiness plan.

First
Quarter 2026 Financial Results:

Balance Sheet and Cash Flow Highlights

• Cash, cash equivalents and short-term investments totaled $17.1 million as of March 31, 2026. The Company expects its current capital to fund projected operations and key clinical milestones through the fourth quarter of 2026, including completion of its Phase 2a extension study for nimacimab and initial manufacturing to enable the anticipated Phase 2b clinical study, but excluding the anticipated clinical cost of a proposed Phase 2b clinical study and additional anticipated drug manufacturing costs to supply any such Phase 2b study.

Operatin


g Results

• R&D Expenses
  Research and development (R&D) expenses for the three months ended March 31, 2026, were $7.9 million, as compared to $7.2 million for the same period in 2025. The increase was primarily due to contract manufacturing, clinical trial costs associated with our clinical study for nimacimab, discovery research and development expenses, salaries and stock-based compensation expense, and consulting advisory and professional fees.

• G&A Expenses
  General and administrative (G&A) expenses for the three months ended March 31, 2026, were $4.7 million, as compared to $4.6 million for the same period in 2025. The increase was primarily related to increased legal fees, partially offset by decreases in investor relations, marketing and communications expenses, salaries, benefits and other direct employee related costs, and consulting, advisory and professional fees.

• Net Loss
  Net loss for the three months ended March 31, 2026, totaled $12.5 million, with non-cash stock-based compensation expense of $1.5 million, compared to $11.1 million for the same period in 2025, with non-cash stock-based compensation expense of $2.2 million.

ABOUT SKYE BIOSCIENCE

Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye’s strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2a clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn.

FORWARD LOOKING STATEMENTS

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements relating to: nimacimab’s potential as a combination or maintenance therapy by supplement GLP-1 therapies; future clinical development of nimacimab, including the initiation and design of any future clinical trials; expectations regarding the CRC’s review of available Cohort 1 safety data to determine whether safe-to-proceed criteria have been met to initiate enrollment in Cohort 2; the outcome of Skye’s evaluation of its manufacturing process improvements, supply-chain options and cost of goods levers; the expected timing for reporting data from the Phase 2a extension study; and the Company’s cash runway. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “planning,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important risks and uncertainties, including, without limitation, the initiation and design of any future clinical trials will be impacted by the Company’s capital resources, the Company’s ability to obtain additional sources of capital, program considerations and potentially other factors outside the Company’s control; the potential for additional weight loss after 26 weeks may not ultimately be observed; there is no guarantee that higher dosing of nimacimab will achieve increased efficacy, and likewise it is possible that higher dosing will produce adversely different safety and tolerability results than those observed to date; the Company’s dependence on third parties in connection with product manufacturing; research and preclinical and clinical testing; the Company’s ability to advance, obtain regulatory approval of and ultimately commercialize nimacimab; competitive products or approaches limiting the commercial value of nimacimab; the timing and results of preclinical and clinical trials; the Company’s ability to fund development activities and achieve development goals; the impact of any global pandemics, inflation, supply chain issues, government shutdowns, high interest rates, adverse regulatory changes; the Company’s ability to protect its intellectual property; risks associated with the Company’s common stock and the other important factors discussed under the caption “Risk Factors” in the Company’s filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause the Company’s views to change. 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 press release.

CONTACTS

Investor Relations


[email protected]

(858) 410-0266

LifeSci Advisors, Mike Moyer
[email protected]
(617) 308-4306

Media Inquiries
LifeSci Communications, Michael Fitzhugh
[email protected]
(628) 234-3889