Market Newsdesk

December 20, 2024 4:04 pm

SAMFINE CREATION HOLDINGS GROUP LIMITED Announces First Half 2024 Unaudited Financial Results

HONG KONG, Dec. 20, 2024 (GLOBE NEWSWIRE) — SAMFINE CREATION HOLDINGS GROUP LIMITED (Nasdaq: SFHG) (the “Company” or “Samfine”), a printing service provider headquartered in Hong Kong, today announced its unaudited financial results for the six months ended June 30, 2024.

Overview:

Revenue was HK$81.9 million (US$10.5 million) for the six months ended June 30, 2024, representing an increase of 61.3% from HK$50.8 million for the same period in 2023.
Net income was HK$0.8 million (US$106,105) for the six months ended June 30, 2024, as compared with a net loss of HK$3.8 million for the same period in 2023.

Six Month Financial Results Ended June 30, 2024

Revenue. Revenue increased by 61.3% to HK$81,934,259 (US$10,493,226) for the six months ended June 30, 2024 from HK$50,800,321 for the six months ended June 30, 2023. The overall increase in revenue was mainly driven by the increase in demand of book products and novelty and packaging products from customers.

General and administrative expenses. General and administrative expenses increased by 9.2% to HK$11,081,674 (US$1,419,217) for the six months ended June 30, 2024 from HK$10,152,410 for the six months ended June 30, 2023, principally due to increase in legal and professional fee.

Selling and marketing expenses. Selling and marketing expenses increased by 37.5% to HK$5,474,255 (US$701,082) for the six months ended June 30, 2024 from HK$3,982,211 for the six months ended June 30, 2023. The overall increase in selling and marketing expenses was mainly driven by the increase in transportation costs.

Net income. Net income increased by 121.8% to a net income of HK$828,511 (US$106,105) for the six months ended June 30, 2024 from a net loss of HK$3,797,489 for the six months ended June 30, 2023. The increase in net income was mainly due to the increase in assessable profit resulting from the increase in revenue.

About SAMFINE CREATION HOLDINGS GROUP LIMITED

SAMFINE CREATION HOLDINGS GROUP LIMITED is an established one-stop printing service provider which principally provides printing services in Hong Kong and the PRC. With over 20 years of experience in the printing industry, its operating subsidiaries offer a wide range of printed products such as book products and novelty and packaging products. Its operating subsidiaries’ customers principally comprise of book traders located in Hong Kong whose clients are located around the world, mainly in the U.S. and Europe.

Exchange Rate Information

The Company is a holding company with operations conducted in Hong Kong and the PRC through its operating subsidiaries in Hong Kong and the PRC, Samfine HK and Samfine SZ, respectively. SFHG’s reporting currency is HKD. This prospectus contains translations of HKD into U.S. dollars solely for the convenience of the reader. Unless otherwise noted, all translations from HKD to U.S. dollars and from U.S. dollars to HKD in this prospectus were calculated at the noon buying rate of US$1 = HK$7.8083 on June 28, 2024, as published in H.10 statistical release of the United States Federal Reserve Board. We make no representation that the HKD or U.S. dollar amounts referred to in this prospectus could have been or could be converted into U.S. dollars or HKD, as the case may be, at any particular rate or at all.

Forward-Looking Statements

Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. The Company cautions investors that actual results may differ materially from the anticipated results, and encourages investors to read the risk factors contained in the Company’s final prospectus and other reports it files with the SEC before making any investment decisions regarding the Company’s securities. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law.

Rounding Amounts and Percentages

Certain amounts and percentages included in this press release have been rounded for ease of presentation. Percentage figures included in this press release have not in all cases been calculated on the basis of such rounded figures, but on the basis of such amounts prior to rounding.

For investor and media inquiries, please contact:

SAMFINE CREATION HOLDINGS GROUP LIMITED

Investor Relations

Email: [email protected]

Telephone: (852) 3589 1500

SAMFINE CREATION HOLDINGS GROUP LIMITED AND ITS SUBSIDIARIES UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION AS OF DECEMBER 31, 2023 AND JUNE 30, 2024

	As of December 31, 2023	As of June 30, 2024	As of June 30, 2024
	HK$	HK$	US$
ASSETS	(Audited)	(Unaudited)	(Unaudited)
CURRENT ASSETS
Cash and cash equivalents	17,349,390	17,564,301	2,249,440
Restricted cash	6,347,680	7,852,453	1,005,655
Accounts receivable, net	31,670,733	47,182,229	6,042,574
Prepayments and other current assets, net	10,302,355	13,698,032	1,754,291
Investment in life insurance policy, net	1,564,333	1,565,203	200,454
Due from a related party	2,086,415	2,416,977	309,540
Inventories, net	8,293,287	10,464,922	1,340,231
Prepaid income tax	8,003	8,003	1,025
Total current assets	77,622,196	100,752,120	12,903,210

NON-CURRENT ASSETS
Plant and equipment, net	15,817,168	18,934,526	2,424,923
Intangible assets, net	869,832	651,620	83,452
Other non-current assets	1,985,940	—	—
Prepayment for acquisition of plant and equipment	1,357,434	290,668	37,226
Right-of-use assets, net	5,022,022	4,615,352	591,083
Deferred tax assets, net	2,640,387	2,417,601	309,620
Total non-current assets	27,692,783	26,909,767	3,446,304
Total assets	105,314,979	127,661,887	16,349,514

LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts and bills payable	47,485,156	67,107,440	8,594,373
Accruals and other payables	7,203,230	13,863,430	1,775,474
Banks and other borrowings	9,559,450	12,095,674	1,549,079
Due to related parties	2,032,193	1,494,193	191,360
Operating lease liabilities	3,928,046	3,492,618	447,296
Finance lease liabilities	145,240	9,509	1,218
Tax payable	10,095	—	—
Total current liabilities	70,363,410	98,062,864	12,558,800

NON-CURRENT LIABILITIES
Banks and other borrowings	10,514,517	4,841,582	620,056
Operating lease liabilities	1,093,976	1,122,734	143,787
Total non-current liabilities	11,608,493	5,964,316	763,843
Total liabilities	81,971,903	104,027,180	13,322,643

COMMITMENTS AND CONTINGENCIES

SHAREHOLDERS’ EQUITY
Ordinary shares: US$0.0000625 par value, 800,000,000 shares authorized, 18,000,000 shares issued and outstanding as of December 31, 2023 and June 30, 2024	8,775	8,775	1,125
Additional paid-in capital	15,491,225	15,491,225	1,983,281
Accumulated other comprehensive income	4,465,962	3,929,082	503,856
Retained earnings	3,377,114	4,205,625	538,609
Total shareholders’ equity	23,343,076	23,634,707	3,026,871
Total liabilities and shareholders’ equity	105,314,979	127,661,887	16,349,514

SAMFINE CREATION HOLDINGS GROUP LIMITED AND ITS SUBSIDIARIES UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE INCOME (LOSS) FOR THE SIX MONTHS ENDED JUNE 30, 2023 AND 2024

	Six months ended June 30,
	2023		2024		2024
	HK$		HK$		US$
REVENUE	50,800,321		81,934,259		10,493,226

COST OF REVENUE	(40,455,750	)	(64,895,629	)	(8,311,109	)
Gross profit	10,344,571		17,038,630		2,182,117

OPERATING EXPENSES
Selling and marketing	(3,982,211	)	(5,474,255	)	(701,082	)
General and administrative	(10,152,410	)	(11,081,674	)	(1,419,217	)
Total expenses	(14,134,621	)	(16,555,929	)	(2,120,299	)
(LOSS) INCOME FROM OPERATION	(3,790,050	)	482,701		61,818

OTHER EXPENSES
Interest income	66,229		66,785		8,553
Interest expense	(693,483	)	(682,011	)	(87,344	)
Other income	368,773		291,314		37,308
Other gain, net	252,386		892,516		114,303
Total other (expenses) income, net	(6,095	)	568,604		72,820
(LOSS) INCOME BEFORE INCOME TAX EXPENSE	(3,796,145	)	1,051,305		134,638
INCOME TAX EXPENSE	(1,344	)	(222,794	)	(28,533	)
NET (LOSS) INCOME	(3,797,489	)	828,511		106,105
FOREIGN CURRENCY TRANSLATION ADJUSTMENT	(777,889	)	(536,880	)	(68,758	)
TOTAL COMPREHENSIVE (LOSS) INCOME	(4,575,378	)	291,631		37,347
Weighted average number of ordinary shares:
Basic and diluted	18,000,000		18,000,000		18,000,000
(LOSS) EARNINGS PER SHARE:
BASIC AND DILUTED	(0.21	)	0.05		0.01

December 20, 2024 4:04 pm

Onfolio Holdings Inc. Announces Quarterly Preferred Stock Cash Dividend of $0.75 Per Share

WILMINGTON, Del., Dec. 20, 2024 (GLOBE NEWSWIRE) — Onfolio Holdings Inc. (Nasdaq: ONFO, ONFOW) (OTC: ONFOP) (the “Company” or “Onfolio”), a company that acquires and manages a diversified portfolio of online businesses, today announced that its Board of Directors has declared a regular quarterly dividend of $0.75 per share on the outstanding shares of the Company’s series A preferred stock.

The dividend is payable on December 31, 2024, to shareholders of record as of the close of business on December 21, 2024.

About Onfolio Holdings

Onfolio acquires and manages a diversified portfolio of online businesses. Onfolio acquires business that meet its investment criteria, being that such businesses operate in sectors with long-term growth opportunities, have positive and stable cash flows, face minimal threats of technological or competitive obsolescence and can be managed by our existing team or have strong management teams largely in place. The Company excels at finding acquisition opportunities where the seller has not fully optimized their business, and Onfolio’s experience and skillset allows it to add increased value to these existing businesses. Visit www.onfolio.com for more information.

Safe Harbor Statement

The information posted in this release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by use of the words “may,” “will,” “should,” “plans,” “explores,” “expects,” “anticipates,” “continues,” “estimates,” “projects,” “intends,” and similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing new customer offerings, changes in customer order patterns, changes in customer offering mix, continued success in technological advances and delivering technological innovations, delays due to issues with outsourced service providers, those events and factors described by us in Item 1.A “Risk Factors” in our most recent Form 10-K and Form 10-Q; other risks to which our Company is subject; other factors beyond the Company’s control. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact
[email protected]

December 20, 2024 4:04 pm

Bridgeline to Report Financial Results for the Fourth Quarter of Fiscal 2024

WOBURN, Mass., Dec. 20, 2024 (GLOBE NEWSWIRE) — Bridgeline Digital, Inc. (NASDAQ: BLIN), a global leader in AI-powered marketing technology, announced today that it will release its financial results for the fourth quarter of fiscal 2024 after market close on Monday, December 23, 2024.

On that day, Ari Kahn, the Company’s President and Chief Executive Officer, and Thomas Windhausen, the Company’s Chief Financial Officer, plan to host a live conference call at 4:30 p.m. ET to discuss the financial results.

The details and registration link for the conference call and replay are as follows:

What:	Bridgeline Digital Fourth Quarter 2024 Earnings Call
When:	Monday, December 23, 2024
Time:	4:30 p.m. ET
Registration:	https://register.vevent.com/register/BIa2b7e1f034b94ac0a2c6017e5f9e8d15
Listen Only:	https://edge.media-server.com/mmc/p/7vs4y5pi

Participants can register for the conference call using the URL above. Registration in advance of the call is recommended. Once registered, participants will receive dial-in numbers and their unique PIN number.

About Bridgeline Digital

Bridgeline helps companies grow online revenues by increasing their traffic, conversion rate, and average order value through its suite of apps. To learn more, please visit www.bridgeline.com or call (800) 603-9936.

Safe Harbor for Forward-Looking Statements

Statement under the Private Securities Litigation Reform Act of 1995

All statements included in this press release, other than statements or characterizations of historical fact, are forward-looking statements. These “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, are based on our current expectations, estimates and projections about our industry, management’s beliefs, and certain assumptions made by us, all of which are subject to change. Forward-looking statements can often be identified by words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” “ongoing,” similar expressions, and variations or negatives of these words. These statements appear in a number of places in this press release and include statements regarding the intent, belief or current expectations of Bridgeline Digital, Inc. These forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions, including, but not limited to, business operations and the business of our customers, suppliers and partners; our ability to retain and upgrade current customers, increasing our recurring revenue, our ability to attract new customers, our revenue growth rate; our history of net loss and our ability to achieve or maintain profitability; instability in the financial markets, including the banking sector; our liability for any unauthorized access to our data or our users’ content, including through privacy and data security breaches; any decline in demand for our platform or products; changes in the interoperability of our platform across devices, operating systems, and third party applications that we do no control; competition in our markets; our ability to respond to rapid technological changes, extend our platform, develop new features or products, or gain market acceptance for such new features or products, particularly in light of potential disruptions to the productivity of our employees resulting from remote work; our ability to manage our growth or plan for future growth, and our acquisition of other businesses and the potential of such acquisitions to require significant management attention, disrupt our business, or dilute stockholder value; the volatility of the market price of our common stock, the ability to maintain our listing on the NASDAQ Capital Market, or our ability to maintain an effective system of internal controls as well as other risks described in our filings with the Securities and Exchange Commission. Any of such risks could cause our actual results to differ materially and adversely from those expressed in any forward-looking statement. These forward-looking statements assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

For more information, please contact:

Thomas Windhausen
Bridgeline Digital, Inc.
Chief Financial Officer
[email protected]

December 20, 2024 4:03 pm

Giftify, Inc. Announces $5.0 Million Registered Direct Offering

SCHAUMBURG, IL, Dec. 20, 2024 (GLOBE NEWSWIRE) — Giftify, Inc. (NASDAQ: GIFT) (the “Company”), the owner and operator of leading digital platforms, CardCash.com and Restaurant.com, with a focus on incentives and rewards in retail, dining & entertainment experiences, today announced that it entered into a securities purchase agreement with certain individual investors to purchase approximately $5.0 million shares of its common stock (or common stock equivalents in lieu thereof) in a registered direct offering.

The gross proceeds to the Company from the registered direct offering are estimated to be approximately $5.0 million, before deducting the placement agent’s fees and other estimated offering expenses. The offering is expected to close on or about December 26, 2024, subject to the satisfaction of customary closing conditions.

Craft Capital LLC is acting as the exclusive placement agent for the offering.

The proposed offering of the securities described above is being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-282322) filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on October 15, 2024, and the accompanying prospectus contained therein.

The offering is being made only by means of a prospectus supplement and accompanying prospectus. The prospectus supplement describing the terms of the public offering will be filed with the SEC prior to the closing and will form a part of the effective registration statement.

Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Craft Capital LLC Attention: Syndicate Department, 377 Oak St #402, Garden City NY 11530, or by telephone at (516) 833-1325.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Giftify, Inc.

Giftify, Inc. is a pioneer in the incentive and rewards industry with a focus on retail, dining & entertainment experiences, as the owner and operator of leading digital platforms, CardCash.com and Restaurant.com. CardCash.com is a leading secondary gift card exchange platform, allowing consumers and retailers to realize value by buying and selling gift cards at various scales. Its Restaurant.com is the nation’s largest restaurant-focused digital deals brand. Restaurant.com and our Corporate Incentives division connect digital consumers, businesses and communities offering thousands of dining, retail and entertainment deals options nationwide at over 184,000 restaurants and retailers. Restaurant.com prides itself on offering the best deal, every meal. Our gift cards and restaurant certificates allow customers to save at thousands of restaurants across the country with just a few clicks.

For more information, visit: www.giftifyinc.com and www.cardcash.com and https://www.restaurant.com.

Forward-Looking Statements

Press Releases may include forward-looking statements. In particular, the words “believe,” “may,” “could,” “should,” “expect,” “anticipate,” “estimate,” “project,” “propose,” “plan,” “intend,” and similar conditional words and expressions are intended to identify forward-looking statements. Any statements made in this news release about an action, event or development, are forward-looking statements. Such statements are based upon assumptions that in the future may prove not to have been accurate and are subject to significant risks and uncertainties. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of the company. Accordingly, you should not place undue reliance on these forward-looking statements. Although the company believes that the expectations reflected in the forward-looking statements are reasonable, it can give no assurance that its forward-looking statements will prove to be correct. Investors are cautioned that any forward-looking statements are not guarantees of future performance and actual results or developments may differ materially from those projected. The forward-looking statements in this press release are made as of the date hereof. The company takes no obligation to update or correct its own forward-looking statements, except as required by law or those prepared by third parties that are not paid by the company. Statements in this press release that are not historical fact may be deemed forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Although Giftify, Inc. believes the expectations reflected in any forward-looking statements are based on reasonable assumptions, Giftify, Inc. is unable to give any assurance that its expectations will be attained. Factors that could cause actual results to differ materially from expectations include the company’s ability identify a suitable business model for the corporation.

Investors Contacts:

ClearThink
[email protected]

December 20, 2024 4:03 pm

ARMLOGI HOLDING CORP. CLOSES ON $5 MILLION SECOND TRANCHE OF PRE-PAID ADVANCE UNDER A STANDBY EQUITY PURCHASE AGREEMENT

WALNUT, CA, Dec. 20, 2024 (GLOBE NEWSWIRE) — Armlogi Holding Corp. (“Armlogi” or the “Company”) (Nasdaq: BTOC), a U.S.-based warehousing and logistics service provider that offers a comprehensive package of supply-chain solutions related to warehouse management and order fulfillment, today announced that it has closed on the $5 million second tranche of the Pre-Paid Advance (as defined below) pursuant to a Standby Equity Purchase Agreement (the “SEPA”) the Company entered into with YA II PN, Ltd. (“YA”), a fund managed by Yorkville Advisors Global, LP.

As previously announced on November 25, 2024, Armlogi entered into the SEPA, where, pursuant to the terms of the SEPA, Armlogi will have the right, from time to time, until December 1, 2026, to require the Investor to purchase up to $50 million of shares of common stock of the Company, subject to certain limitations and conditions set forth in the SEPA, by delivering written notice to YA (an “Advance Notice”). Pursuant to the SEPA, YA will advance to the Company, subject to the satisfaction of certain conditions as set forth therein, the principal amount of $21 million (the “Pre-Paid Advance”), which will be evidenced by convertible promissory notes (the “Promissory Notes”, together with the “SEPA”, the “Offering”) in three tranches. The Company has now received two tranches of the Pre-Paid Advance of $5 million each.

“This second tranche closing represents another important milestone in strengthening Armlogi’s financial position and advancing our growth initiatives,” said Aidy Chou, Chairman and Chief Executive Officer of Armlogi. “The continued support from Yorkville Advisors through our SEPA arrangement provides us with flexible capital to execute our strategic plans and enhance our comprehensive supply-chain solutions platform. We remain focused on delivering value to our customers and shareholders as we continue to expand our warehousing and logistics capabilities.”

About Armlogi Holding Corp.

Armlogi Holding Corp., based in Walnut, CA, is a fast-growing U.S.-based warehousing and logistics service provider that offers a comprehensive package of supply-chain solutions relating to warehouse management and order fulfillment. The Company caters to cross-border e-commerce merchants looking to establish overseas warehouses in the U.S. market. With ten warehouses covering over three million square feet, the Company offers comprehensive one-stop warehousing and logistics services. The Company’s warehouses are equipped with facilities and technology for handling and storing large and bulky items. For more information, please visit www.armlogi.com.

Safe Harbor Statement

This press release contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us.

Company Contact:

[email protected]

Investor Relations Contact:

Matthew Abenante, IRC
President
Strategic Investor Relations, LLC
Tel: 347-947-2093

Email: [email protected]

December 20, 2024 4:03 pm

SigmaTron International, Inc. Reports Financial Results For the Second Quarter of Fiscal 2025

ELK GROVE VILLAGE, Ill., Dec. 20, 2024 (GLOBE NEWSWIRE) — SigmaTron International, Inc. (NASDAQ: SGMA), an electronic manufacturing services company (the “Company”), today reported revenues and earnings for the fiscal quarter ended October 31, 2024.

For the three month period ended October 31, 2024, revenues decreased $24 million, or 24 percent, to $74.7 million compared to $98.7 million for the same quarter in the prior year. Net income/(loss) for the three month period ended October 31, 2024 was a loss of $9.5 million compared to break even for the same period in the prior year. Approximately $3.3 million of expenses were recorded during the second quarter related to debt modification, expensing of deferred financing costs and lender warrants after remeasurement. Basic and diluted income/(loss) per share for the three month period ended October 31, 2024 was a loss of $1.55, compared to $0.00 income per share for the same period in the prior year.

For the six month period ended October 31, 2024, revenues decreased $37.3 million, or 19 percent, to $159.5 million, compared to $196.8 million for the same period in the prior year. Net income/(loss) for the six month period ended October 31, 2024, was a net loss of $12.8 million, compared to net income of $0.3 million for the same period in the prior year. Approximately $3.3 million of expenses were recorded during the second quarter related to debt modification, expensing of deferred financing costs and lender warrants after remeasurement. Basic and diluted income/(loss) per share for the six month period ended October 31, 2024 was a loss of $2.08, compared to $0.05 income per share for the same period in the prior year.

Commenting on SigmaTron International Inc.’s second quarter fiscal 2025 results, Gary R. Fairhead, Chief Executive Officer and Chairman of the Board, said “Unfortunately the softness we’ve seen in our revenue stream has continued during the second quarter. Sequentially, our first quarter for fiscal 2025 revenue was $84.8 million and for the second quarter, our revenue was $74.7 million. We currently expect the depressed revenue levels to continue for our third fiscal quarter, in part because of the holidays in December for North America and at the end of January in Asia. As you would expect, this level of revenue resulted in another loss for the second quarter, which included a non-cash charge for deferred financing and warrant expenses that totaled approximately $3.3 million.

On a positive note, the Company reported an operating profit in October, demonstrating that our restructuring efforts are now showing a significant impact. We continue to right-size our Company offering significant upside for the operations. The softness we continue to encounter was tied to the general economy and exacerbated by the supply chain volatility in the electronic component marketplace, with customers having overordered in the recent past because of the uncertainty related to acquiring certain components for the electronic assemblies. We believe that the excess inventory that was the result of this behavior has in large part been consumed, which should lead to overall demand increasing in 2025.

“In the short term, we continue to see soft revenue in terms of our backlog. However, most of our customers are starting to indicate that they view calendar 2025 as a stronger and growing economy and expect the current trend to have bottomed out. We have seen this with several customers where some modest orders have been pulled in and there has been increased activity with new opportunities. It will still take a while to get to where we want to be but at least the current trend appears to be positive after the third quarter. In addition to right-sizing the Company, we have continued to remain focused on reducing inventory further. We made modest progress in that area in the second quarter, but we fully expect to see significant gains in our reduction efforts during the third quarter.

“In our first quarter press release, I also mentioned that we were focused on activities to de-lever our balance sheet. I’m pleased to announce that on December 13, 2024, SigmaTron entered into a sale/leaseback of our Elk Grove Village property. We have signed a three-year lease with two one-year options on the property. From an accounting perspective, not only have we reduced our bank debt, but we will have a one-time capital gain of approximately $7 million to report in our third quarter results. We continue to look at other options for the Company strategically, with the assistance of Lincoln International. We continue to enjoy good relationships with our customers and supply chain and expect that to continue as we continue to go through the process.”

About SigmaTron International, Inc.

Headquartered in Elk Grove Village, Illinois, SigmaTron International, Inc. operates in one reportable segment as an independent provider of electronic manufacturing services (“EMS”). The EMS segment includes printed circuit board assemblies, electro-mechanical subassemblies and completely assembled (box-build) electronic products. The Company and its wholly-owned subsidiaries operate manufacturing facilities in Elk Grove Village, Illinois; Acuna, Chihuahua, and Tijuana Mexico; Union City, California; Suzhou, China; and Biên Hòa City, Vietnam. In addition, the Company maintains an International Procurement Office and Compliance and Sustainability Center in Taipei, Taiwan. The Company also provides design services in Elk Grove Village, Illinois, U.S.

Forward-Looking Statements

Note: This press release contains forward-looking statements. Words such as “continue,” “anticipate,” “will,” “expect,” “believe,” “plan,” and similar expressions identify forward-looking statements. These forward-looking statements are based on the current expectations of the Company. Because these forward-looking statements involve risks and uncertainties, the Company’s plans, actions and actual results could differ materially. Such statements should be evaluated in the context of the direct and indirect risks and uncertainties inherent in the Company’s business including, but not necessarily limited to, the Company’s continued dependence on certain significant customers; the continued market acceptance of products and services offered by the Company and its customers; pricing pressures from the Company’s customers, suppliers and the market; the activities of competitors, some of which may have greater financial or other resources than the Company; the variability of the Company’s operating results; the impact of material weaknesses in internal controls over financial reporting; the results of long-lived assets and goodwill impairment testing; the risks inherent in any merger, acquisition or business combination, including the ability to achieve the expected benefits of acquisitions as well as the expenses of acquisitions; the collectability of aged account receivables; the variability of the Company’s customers’ requirements; the impact of inflation on the Company’s operating results; the availability and cost of necessary components and materials; the impact acts of war may have to the supply chain; the ability of the Company and its customers to keep current with technological changes within its industries; regulatory compliance, including conflict minerals; the continued availability and sufficiency of the Company’s credit arrangements; the costs of borrowing under the Company’s senior and subordinated credit facilities, including under the rate indices that replaced LIBOR; increasing interest rates; the ability to meet the Company’s financial and restrictive covenants under its loan agreements; changes in U.S., Mexican, Chinese, Vietnamese or Taiwanese regulations affecting the Company’s business; the turmoil in the global economy and financial markets; public health crises, including COVID-19 and variants; the continued availability of scarce raw materials, exacerbated by global supply chain disruptions, necessary for the manufacture of products by the Company; the stability of the U.S., Mexican, Chinese, Vietnamese and Taiwanese economic, labor and political systems and conditions; global business disruption caused by the Russian invasion of Ukraine and related sanctions and the Israel-Hamas conflict; currency exchange fluctuations; and the ability of the Company to manage its growth. These and other factors which may affect the Company’s future business and results of operations are identified throughout the Company’s Annual Report on Form 10-K, and as risk factors, may be detailed from time to time in the Company’s filings with the Securities and Exchange Commission. These statements speak as of the date of such filings, and the Company undertakes no obligation to update such statements in light of future events or otherwise unless otherwise required by law.

For Further Information Contact:
SigmaTron International, Inc.
Frank Cesario
1-800-700-9095

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS


	Three Months			Three Months			Six Months			Six Months
	Ended			Ended			Ended			Ended
	October 31,			October 31,			October 31,			October 31,
		2024			2023			2024			2023

Net sales		74,719,360			98,691,684			159,496,338			196,822,040

Cost of products sold		67,815,156			89,003,929			146,186,940			177,483,065

Gross profit		6,904,204			9,687,755			13,309,398			19,338,975

Selling and administrative expenses		6,370,511			6,613,634			12,994,377			13,456,439

Operating income		533,693			3,074,121			315,021			5,882,536

Change in fair value of warrants		(626,000	)		–			(626,000	)		–
Other expense		(4,701,108	)		(2,702,193	)		(6,969,383	)		(5,402,644	)

(Loss) income before income tax		(4,793,415	)		371,928			(7,280,362	)		479,892

Income tax benefit (expense)		(4,673,254	)		(343,666	)		(5,475,467	)		(189,531	)

Net (loss)/income	$	(9,466,669	)	$	28,262		$	(12,755,829	)	$	290,361



Net (loss)/income per common share – basic	$	(1.55	)	$	0.00		$	(2.08	)	$	0.05

Net (loss)/income per common share – diluted	$	(1.55	)	$	0.00		$	(2.08	)	$	0.05

Weighted average number of common equivalent
shares outstanding – assuming dilution		6,119,288			6,190,696			6,119,288			6,166,524


CONDENSED CONSOLIDATED BALANCE SHEETS

	October 31,			April 30,
		2024			2024

Assets:

Current assets	$	160,920,235			175,902,619

Machinery and equipment-net		31,626,827			33,755,078

Deferred income taxes		–			4,432,210
Intangibles		816,538			979,188
Other assets		11,298,366			8,724,880

Total assets	$	204,661,966		$	223,793,975

Liabilities and stockholders’ equity:

Current liabilities	$	138,582,021			145,888,791

Long-term obligations		12,628,019			11,832,931

Stockholders’ equity		53,451,926			66,072,253

Total liabilities and stockholders’ equity	$	204,661,966		$	223,793,975

December 20, 2024 4:03 pm

Aptorum Group Limited Reports Financial Results and Business Update for the Six Months Ended June 30, 2024

Aptorum Group Limited Reports Financial Results and Business Update for the Six Months Ended June 30, 2024

NEW YORK–(BUSINESS WIRE)–
Aptorum Group Limited (NASDAQ: APM) (“Aptorum Group” or the “Company”), a clinical stage biopharmaceutical company dedicated to meeting unmet medical needs in oncology, autoimmune and infectious diseases, today provided a business update and announced financial results for the six months ended June 30, 2024.

“Our team and Yoov have spent considerable time and effort on the due diligence process, the negotiation of definitive terms, and the preparation of necessary transactional and listing documentation. However, current market conditions have introduced significant uncertainty regarding the availability of the required funding for the transaction. After careful consideration, our Board has determined that it is no longer in the best interests of our shareholders to proceed with this transaction. Despite this, we will continue to explore other business combination opportunities that we believe will enhance shareholder value,” stated Mr. Ian Huen, Chief Executive Officer and Executive Director of Aptorum Group Limited.

Corporate Highlights

On October 24, 2024, the Company and Yoov Group Holding Limited (“Yoov”) entered into a termination agreement and the anticipated reverse takeover transaction with Yoov was terminated.

Financial Results for the Six Months Ended June 30, 2024

Aptorum Group reported a net loss of $2.7 million for the six months ended June 30, 2024 compared to $6.6 million for the same period in 2023. The decrease in net loss in the current period was driven by the decrease in operating expenses by $4.1 million due to the implementation of stringent budgetary control measures, as a result of the Company’s exclusive emphasis on the previous anticipated RTO.

Research and development expenses were $2.0 million for the six months ended June 30, 2024 compared to $3.2 million for the same period in 2023. Before the Merger Agreement was terminated, we determined it was best to focus all of our attention and resources on completing the Merger and therefore paused the majority of our R&D activities during that time; following the termination of the Merger Agreement in the fourth quarter of fiscal 2024, we determined that searching for other business combination opportunities could maximize shareholder value, and our R&D activities remain suspended.

General and administrative fees were $0.3 million for the six months ended June 30, 2024 compared to $1.3 million for the same period in 2023. The decrease in general and administrative fees was primary due to the streamlining of our operations to focus on preparation for the Merger, which has since been abandoned.

Legal and professional fees were $0.4 million for the six months ended June 30, 2024 compared to $1.7 million for the same period in 2023. The decrease in legal and professional fees was attributed to the lack of non-routine activities that were present in the same period last year, such as the implementation of reverse stock split, and amendments to the memorandum and articles of association. The absence of such non-routine exercises in the current period has resulted in a decrease in legal and professional fees.

As of June 30, 2024, cash and restricted cash totaled approximately $0.8 million and total equity was approximately $13.2 million.

APTORUM GROUP LIMITED UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS June 30, 2024 and December 31, 2023 (Stated in U.S. Dollars)

	June 30, 2024			December 31, 2023
ASSETS
Current assets:
Cash	$	783,085		$	2,005,351
Accounts receivable		21,800			47,709
Amounts due from related parties		3,595			961
Other receivables and prepayments		725,616			422,071
Total current assets		1,534,096			2,476,092
Property and equipment, net		–			1,663,926
Operating lease right-of-use assets		–			182,057
Long-term investments		16,098,846			16,098,846
Intangible assets, net		–			147,347
Long-term deposits		71,823			71,823
Total Assets	$	17,704,765		$	20,640,091

LIABILITIES AND EQUITY

LIABILITIES
Current liabilities:
Amounts due to related parties	$	79,180		$	79,180
Accounts payable and accrued expenses		1,148,235			1,894,341
Operating lease liabilities, current		89,145			125,232
Total current liabilities		1,316,560			2,098,753
Operating lease liabilities, non-current		62,718			99,485
Convertible notes to a related party		3,148,500			3,058,500
Total Liabilities	$	4,527,778		$	5,256,738

Commitments and contingencies		–			–

EQUITY
Class A Ordinary Shares ($0.00001 par value, 9,999,996,000,000 shares authorized, 3,674,164 shares issued and outstanding as of June 30, 2024; 2,937,921 shares issued and outstanding as of December 31, 2023)	$	37		$	31
Class B Ordinary Shares ($0.00001 par value; 4,000,000 shares authorized, 1,796,934 shares issued and outstanding as of June 30, 2024; 2,243,776 shares issued and outstanding as of December 31, 2023)		18			22
Additional paid-in capital		93,470,186			93,018,528
Accumulated other comprehensive loss		(9,762	)		(10,623	)
Accumulated deficit		(70,805,518	)		(68,161,722	)
Total equity attributable to the shareholders of Aptorum Group Limited		22,654,961			24,846,236
Non-controlling interests		(9,477,974	)		(9,462,883	)
Total equity		13,176,987			15,383,353
Total Liabilities and Equity	$	17,704,765		$	20,640,091

APTORUM GROUP LIMITED UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS For the six months ended June 30, 2024 and 2023 (Stated in U.S. Dollars)

	For the six months ended June 30,
	2024			2023
Revenue
Healthcare services income	$	–		$	431,378
Operating expenses
Costs of healthcare services		–			(426,063	)
Research and development expenses		(2,038,923	)		(3,212,366	)
General and administrative fees		(326,187	)		(1,263,019	)
Legal and professional fees		(366,164	)		(1,738,566	)
Other operating expenses		(137,233	)		(330,212	)
Total operating expenses		(2,868,507	)		(6,970,226	)

Other income (expenses)
Loss on investments in marketable securities, net		–			(9,266	)
Interest expense, net		(68,462	)		(93,478	)
Loss on disposal of subsidiaries		(4,271	)		–
Sundry income		282,353			36,803
Total other income (expenses), net		209,620			(65,941	)

Net loss	$	(2,658,887	)	$	(6,604,789	)
Less: net loss attributable to non-controlling interests		(15,091	)		(1,117,685	)

Net loss attributable to Aptorum Group Limited	$	(2,643,796	)	$	(5,487,104	)

Net loss per share – basic and diluted	$	(0.50	)	$	(1.43	)
Weighted-average shares outstanding – basic and diluted		5,339,608			3,849,621

Net loss	$	(2,658,887	)	$	(6,604,789	)
Other comprehensive income (loss)
Exchange differences on translation of foreign operations		861			(7,485	)
Other comprehensive income (loss)		861			(7,485	)
Comprehensive loss		(2,658,026	)		(6,612,274	)
Less: comprehensive loss attributable to non-controlling interests		(15,091	)		(1,117,685	)
Comprehensive loss attributable to the shareholders of Aptorum Group Limited		(2,642,935	)		(5,494,589	)

About Aptorum Group

Aptorum Group Limited (Nasdaq: APM) is a clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutic assets to treat diseases with unmet medical needs, particularly in oncology (including orphan oncology indications) and infectious diseases. The pipeline of Aptorum is also enriched through the co-development of Paths^Dx Test, a novel molecular-based rapid pathogen identification and detection diagnostics technology, with Accelerate Technologies Pte Ltd, commercialization arm of the Singapore’s Agency for Science, Technology and Research.

For more information about the Company, please visit www.aptorumgroup.com.

Disclaimer and Forward-Looking Statements

This press release does not constitute an offer to sell or a solicitation of offers to buy any securities of Aptorum Group.

This press release includes statements concerning Aptorum Group Limited and its future expectations, plans and prospects that constitute “forward-looking statements” within the meaning of the US Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue,” or the negative of these terms or other similar expressions. Aptorum Group has based these forward-looking statements, which include statements regarding projected timelines for application submissions and trials, largely on its current expectations and projections about future events and trends that it believes may affect its business, financial condition and results of operations.

These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions including, without limitation, risks related to its announced management and organizational changes, the continued service and availability of key personnel, its ability to expand its product assortments by offering additional products for additional consumer segments, development results, the company’s anticipated growth strategies, anticipated trends and challenges in its business, and its expectations regarding, and the stability of, its supply chain, and the risks more fully described in Aptorum Group’s Form 20-F and other filings that Aptorum Group may make with the SEC in the future. As a result, the projections included in such forward-looking statements are subject to change and actual results may differ materially from those described herein.

Aptorum Group assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

This press release is provided “as is” without any representation or warranty of any kind.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241220907803/en/

Aptorum Group Limited

Investor Relations Department

[email protected]

+44 20 80929299

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Oncology Health Infectious Diseases General Health Clinical Trials Pharmaceutical Biotechnology

MEDIA:

December 20, 2024 3:49 pm

Vertex Announces US FDA Approval of ALYFTREK™,a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis

Vertex Announces US FDA Approval of ALYFTREK^™,^{a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis}

– ALYFTREK^™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not responsive to other CFTR modulator therapies –

– In head-to-head clinical trials, ALYFTREK was non-inferior on ppFEV₁ and further decreased sweat chloride compared to TRIKAFTA^®–

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people 6 years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to ALYFTREK. See below for Important Safety Information, including a Boxed Warning.

“ALYFTREK is our fifth CFTR modulator to secure FDA approval and represents another significant milestone in our journey to serially innovate and to improve the lives of people living with cystic fibrosis,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “Our north star for more than 20 years has been to address the underlying cause of cystic fibrosis, treat more people with this disease, and bring more people to normal levels of CFTR function — ALYFTREK, with once-daily dosing, efficacy in 31 additional mutations, and lower sweat chloride levels than TRIKAFTA, is another step in achieving this goal.”

This approval is based on the most comprehensive Phase 3 pivotal program ever conducted in CF, including more than 1,000 patients across more than 20 countries and more than 200 sites. These data were previously released at the conclusion of the studies and presented at the North American Cystic Fibrosis Conference in September of this year. The Phase 3 studies in people with CF ages 12 years and older met their primary endpoint (non-inferiority on absolute change from baseline in ppFEV₁ compared to TRIKAFTA) and all key secondary endpoints (including absolute change from baseline in sweat chloride [SwCl] compared to TRIKAFTA). In the Phase 3 study of children with CF ages 6-11 years, ALYFTREK demonstrated safety, the primary endpoint. Secondary endpoints, such as absolute change from baseline in ppFEV₁ and absolute change from baseline in SwCl, were presented, supporting the benefit of ALYFTREK in this age group. ALYFTREK was generally well tolerated across all studies.

“In Phase 3 clinical trials, across a broad range of genotypes, once-daily ALYFTREK demonstrated non-inferiority to TRIKAFTA in ppFEV₁ response and statistically significant improvement in SwCl, a welcomed advancement for the treatment of CF,” said Claire L. Keating, M.D., Co-Director of the Gunnar Esiason Adult Cystic Fibrosis and Lung Program at Columbia University and investigator in the ALYFTREK clinical trial program. “ALYFTREK has the potential to improve the care of patients with CF.”

ALYFTREK is the first, once-daily CFTR modulator. In a recent survey, approximately 75% of physicians reported that more convenient dosing is a very high unmet need for people with CF. Specifically, people with CF will have the added benefit from a once-daily dosing regimen, given the need to take CFTR modulators with fat-containing food. ALYFTREK also offers a potentially transformative option for approximately 150 people with CF in the U.S. with one of 31 mutations who are now eligible for a CFTR modulator for the first time.

ALYFTREK was also submitted to global health authorities and is under regulatory review in the European Union, the United Kingdom, Canada, Switzerland, Australia and New Zealand.

About Cystic Fibrosis

Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 92,000 people globally. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the 30s, but with treatment, projected survival is improving.

Learn more about the importance of sweat chloride (SwCl) in cystic fibrosis.

Today Vertex CF medicines are treating over 68,000 people with CF across more than 60 countries on six continents. This represents 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy.

ALYFTREK U.S. INDICATIONS

ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one indicated mutation.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: DRUG-INDUCED LIVER INJURY AND LIVER FAILURE

Elevated transaminases have been observed in patients treated with ALYFTREK. Cases of serious and potentially fatal drug-induced liver injury and liver failure were reported in patients taking a fixed-dose combination drug containing elexacaftor, tezacaftor, and ivacaftor, which contains the same or similar active ingredients as ALYFTREK. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of elexacaftor/tezacaftor/ivacaftor.

Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating ALYFTREK, every month during the first 6 months of treatment, every 3 months for the next 12 months, and at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or elevated liver function tests (LFTs) at baseline.

Interrupt ALYFTREK for significant elevations in LFTs or in the event of signs or symptoms of liver injury. Consider referral to a hepatologist. Follow patients closely with clinical and laboratory monitoring until abnormalities resolve. If resolved, resume treatment only if benefit is expected to outweigh risk. Closer monitoring is advised after resuming ALYFTREK.

ALYFTREK should not be used in patients with severe hepatic impairment (Child-Pugh Class C). ALYFTREK is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B) and should only be considered when there is a clear medical need, and benefit outweighs risk. If used, monitor patients closely.

WARNINGS AND PRECAUTIONS

Drug-Induced Liver Injury and Liver Failure

Elevated transaminases have been observed in patients treated with ALYFTREK. Cases of serious and potentially fatal drug-induced liver injury and liver failure have been reported in patients with and without a history of liver disease taking a fixed-dose combination drug containing elexacaftor, tezacaftor, and ivacaftor (ELX/TEZ/IVA), which contains the same or similar active ingredients as ALYFTREK. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of ELX/TEZ/IVA
Assess LFTs (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating ALYFTREK, every month during the first 6 months of treatment, every 3 months for the next 12 months, and at least annually thereafter. Consider more frequent monitoring in patients with a history of liver disease, elevated LFTs at baseline, or a history of elevated LFTs with drugs containing ELX, TEZ, and/or IVA
Interrupt ALYFTREK in the event of signs or symptoms of liver injury, which may include:
- Significant elevations in LFTs (e.g., ALT or AST >5x the upper limit or normal (ULN) or ALT or AST >3x ULN with bilirubin >2x ULN)
- Clinical signs or symptoms suggestive of liver injury (e.g., jaundice, right upper quadrant pain, nausea, vomiting, altered mental status, ascites)
Consider referral to a hepatologist and follow patients closely with clinical and laboratory monitoring until abnormalities resolve. If resolved and if benefit is expected to outweigh risk, resume ALYFTREK with close monitoring
ALYFTREK should not be used in patients with severe hepatic impairment. ALYFTREK is not recommended in patients with moderate hepatic impairment and should only be considered when there is a clear medical need and benefit outweighs risk. If used, monitor patients closely

Hypersensitivity Reactions, Including Anaphylaxis

Hypersensitivity reactions, including cases of anaphylaxis, have been reported in the postmarketing setting of drugs containing ELX, TEZ, and/or IVA (same or similar active ingredients in ALYFTREK). If signs or symptoms of serious hypersensitivity reactions develop during ALYFTREK treatment, discontinue ALYFTREK and institute appropriate therapy. Consider benefits and risks for the individual patient to determine whether to resume ALYFTREK

Patients Who Discontinued or Interrupted Elexacaftor-, Tezacaftor-, or Ivacaftor-Containing Drugs Due to Adverse Reactions

There are no available safety data for ALYFTREK in patients who previously discontinued or interrupted treatment with drugs containing ELX/TEZ/IVAr due to adverse reactions. Consider the benefits and risks before using ALYFTREK in these patients. If ALYFTREK is used in these patients, closely monitor for adverse reactions as clinically appropriate

Reduced Effectiveness with Concomitant Use With CYP3A Inducers

Following concomitant use of strong or moderate CYP3A inducers with ALYFTREK, exposures of vanzacaftor, tezacaftor, and deutivacaftor were decreased, which may reduce ALYFTREK effectiveness. Concomitant use with strong or moderate CYP3A inducers is not recommended

Adverse Reactions with Concomitant Use With CYP3A Inhibitors

Following concomitant use of strong or moderate CYP3A inhibitors with ALYFTREK, exposures of vanzacaftor, tezacaftor, and deutivacaftor were increased, which may increase the risk of adverse reactions associated with ALYFTREK. Reduce the ALYFTREK dosage with concomitant use of strong or moderate CYP3A inhibitors

Cataracts

Non-congenital lens opacities have been reported in pediatric patients treated with drugs containing ivacaftor (similar to an active ingredient in ALYFTREK). Baseline and follow-up ophthalmological examinations are recommended in pediatric patients treated with ALYFTREK

ADVERSE REACTIONS

Serious Adverse Reactions

Serious adverse reactions that occurred more frequently with ALYFTREK than with ELX/TEZ/IVA in 2 or more patients (≥0.4%) were influenza (1.5%), increased AST (0.4%), increased GGT (0.4%), depression (0.4%), and syncope (0.4%)

Most Common Adverse Reactions

The most common adverse reactions to ALYFTREK (≥5% of patients and at a frequency higher than ELX/TEZ/IVA by ≥1%) were cough, nasopharyngitis, upper respiratory tract infection, headache, oropharyngeal pain, influenza, fatigue, increased ALT, rash, increased AST, and sinus congestion

USE IN SPECIFIC POPULATIONS

Pediatric Use

The safety and effectiveness of ALYFTREK in patients <6 years of age have not been established

Please click here to see the full U.S. Prescribing Information, including Boxed WARNING for ALYFTREK.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry’s top places to work, including 15 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Reshma Kewalramani, M.D., and Claire L. Keating, M.D., in this press release, statements regarding the eligible patient population for ALYFTREK, expectations for ALYFTREK regulatory submissions to global health authorities, and statements regarding the potential benefits of ALYFTREK, including for patients eligible for a CFTR modulator for the first time. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include risks listed under the heading “Risk Factors” in Vertex’s annual report and in subsequent filings filed with the Securities and Exchange Commission and available through the company’s website at www.vrtx.com and www.sec.gov. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

View source version on businesswire.com: https://www.businesswire.com/news/home/20241220133127/en/

Vertex Pharmaceuticals Incorporated

Investors:

[email protected]

Susie Lisa, CFA: +1 617-341-6108

or

Manisha Pai: +1 617-961-1899

Media:

[email protected]

or

U.S.: 617-341-6992

Heather Nichols: +1 617-839-3607

or

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December 20, 2024 3:43 pm

Renovaro Regains Compliance with NASDAQ Listing Requirement

LOS ANGELES, Dec. 20, 2024 (GLOBE NEWSWIRE) — Renovaro Inc. (NASDAQ: RENB), a pioneer in cancer diagnostics and therapeutics powered by artificial intelligence, today announced that it has received a notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule, 5550(a)(2). The Company’s security will continue to be listed and traded on The Nasdaq Stock Market and this matter is now closed.

Renovaro previously received a notification letter from the Nasdaq Listing Qualifications Department on September 12, 2024, notifying the Company that, over the previous 30 consecutive business days, the closing bid price of the Company’s common stock had been below the minimum of $1.00 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).

About Renovaro

Renovaro https://renovarogroup.com/ aims to accelerate precision and personalized medicine for longevity powered by mutually reinforcing AI and biotechnology platforms for early diagnosis, better-targeted treatments, and drug discovery. Renovaro Inc. includes RenovaroBio with its advanced cell-gene immunotherapy company and Renovaro Cube.

Renovaro Cube has developed an award-winning AI platform that is committed to the early detection of cancer and its recurrence and monitoring subsequent treatments. Renovaro Cube intervenes at a stage where potential therapy can be most effective. Renovaro Cube is a molecular data science company with a background in FinTech and a 12-year history. It brings together proprietary artificial intelligence (AI) technology, multi-omics, multi-modal data, and the expertise of a carefully selected multidisciplinary team to radically accelerate precision medicine and enable breakthrough changes in disease agnostic decision support.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline, platform and fundraising. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as “believes,” “plans,” “expects,” “aims,” “intends,” “potential,” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Renovaro’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Renovaro Inc. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

Investor Relations

Chris Tyson
Executive Vice President
MZ Group – MZ North America
949-491-8235
[email protected]
www.mzgroup.us

For media inquiries, please contact:

karen@Renovaro Cube.com and [email protected]

December 20, 2024 3:38 pm

Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del TRIKAFTA-Responsive Variants

Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del TRIKAFTA-Responsive Variants

– Approximately 300 more people with cystic fibrosis in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time –

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA^® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to TRIKAFTA based on clinical and/or in vitro data. In addition, safety information on liver injury and liver failure has been updated from warnings and precautions to a boxed warning. With this approval, 94 additional non-F508delCFTR mutations have been added to the TRIKAFTA label, and approximately 300 additional people with CF in the U.S. are now eligible for a medicine to treat the underlying cause of their disease for the first time.

“Since its first approval in 2019, TRIKAFTA has had a transformative impact on tens of thousands of people living with cystic fibrosis,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer, Vertex. “With this approval, even more patients may be able to benefit from a medicine that treats the underlying cause of their disease, and we look forward to continuing the work to extend the approvals and availability of our medicines to patients around the world.”

For more information on TRIKAFTA, patient assistance programs or to find additional eligibility details, visit TRIKAFTA.com, VertexGPS.com or vertextreatments.com.

About Cystic Fibrosis

About TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor)

In people with certain types of mutations in the CFTR gene, the CFTR protein is not processed or folded normally within the cell, and this can prevent the CFTR protein from reaching the cell surface and functioning properly. TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface. Elexacaftor and tezacaftor work together to increase the amount of mature protein at the cell surface. Ivacaftor, which is known as a CFTR potentiator, is designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane. The combined actions of elexacaftor, tezacaftor and ivacaftor help hydrate and clear mucus from the airways.

TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation or a mutation in the CFTR gene that is responsive based on clinical and/or in vitro data. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 2 years of age.

The following 94 mutations have been added to the TRIKAFTA^® label for the first time:

1507_1515del9, 2183A→G, A1067P, A107G, A309D, A62P, C491R, D1445N, D565G, D993Y, E116Q, E292K, F1107L, F200I, F587I, G1047R, G1123R, G1247R, G27E, G424S, G480S, G551A, G970S, H620P, H620Q, H939R;H949L, I105N, I125T, I148N, I331N, I506L, I556V, K162E, K464E, L1011S, L137P, L333F, L333H, L441P, L619S, M1137V, M150K, N1088D, N1303I, N186K, N187K, N418S, P140S, P499A, P750L, Q1313K, Q372H, Q493R, Q552P, R1048G, R117C;G576A;R668C, R297Q, R31C, R516S, R555G, R709Q, R75L, S1045Y, S108F, S1118F, S1235R, S549I, T1086I, T1246I, T1299I, T351I, V392G, V603F, Y301C, 2789+5G→A, 3272-26A→G, 3849+10kbC→T, N1303K, 711+3A→G, E831X, 5T;TG12, 5T;TG13, 296+28A→G, 621+3A→G, 1898+3A→G, 2789+ 2insA, 3850-3T→G, 3600G→A, 3849+4A→G, 3849+40A→G, 4005+2T→C, 1341G→A, 3041-15T→G, 2752-26A→G

TRIKAFTA U.S. INDICATIONS

TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on clinical and/or in vitro data.

If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one indicated mutation.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: DRUG-INDUCED LIVER INJURY AND LIVER FAILURE

TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Cases of liver failure leading to transplantation and death have been reported in patients with and without a history of liver disease taking TRIKAFTA, in both clinical trials and the post-marketing setting. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of TRIKAFTA.

Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating TRIKAFTA, then every month during the first 6 months of treatment, every 3 months for the next 12 months, and at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or liver function test (LFT) elevations at baseline.

Interrupt TRIKAFTA for significant elevations in LFTs or in the event of signs or symptoms of liver injury. Consider referral to a hepatologist. Follow patients closely with clinical and laboratory monitoring until abnormalities resolve. If resolved, resume treatment only if the benefit is expected to outweigh the risk. Closer monitoring is advised after resuming TRIKAFTA.

TRIKAFTA should not be used in patients with severe hepatic impairment (Child-Pugh Class C). TRIKAFTA is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B). If used, use with caution at a reduced dosage and monitor patients closely.

WARNINGS AND PRECAUTIONS

Drug-Induced Liver Injury and Liver Failure

TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Liver failure leading to transplantation and death have been reported in patients with and without a history of liver disease taking TRIKAFTA. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of TRIKAFTA
Assess LFTs (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating TRIKAFTA, then every month during the first 6 months of treatment, every 3 months for the next 12 months, at least annually thereafter
Interrupt TRIKAFTA in the event of signs or symptoms of liver injury, which may include:
- Significant elevations in LFTs (e.g. ALT or AST >5x the upper limit of normal (ULN) or ALT or AST >3x ULN with bilirubin >2x ULN)
- Clinical symptoms suggestive of liver injury (e.g., jaundice, right upper quadrant pain, nausea, vomiting, altered mental status, ascites)
Consider referral to a hepatologist and follow patients closely with clinical and laboratory monitoring until the abnormalities resolve. If resolved, and if benefit is expected to outweigh risk, resume TRIKAFTA with close monitoring
TRIKAFTA should not be used in patients with severe hepatic impairment . TRIKAFTA is not recommended in patients with moderate hepatic impairment and should only be considered when there is a clear medical need, and benefit outweighs risk. If used, use with caution at a reduced dosageand monitor patients closely

Hypersensitivity Reactions, Including Anaphylaxis

Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported in the post-marketing setting. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue TRIKAFTA and institute appropriate therapy. Consider benefits and risks for the individual patient to determine whether to resume treatment with TRIKAFTA

Concomitant Use With CYP3A Inducers

Exposure to ivacaftor is significantly decreased and exposure to elexacaftor and tezacaftor are expected to decrease by concomitant use of strong CYP3A inducers, which may reduce the therapeutic effectiveness of TRIKAFTA. Concomitant use with strong CYP3A inducers is not recommended

Concomitant Use With CYP3A Inhibitors

Exposure to elexacaftor, tezacaftor, and ivacaftor are increased when used concomitantly with strong or moderate CYP3A inhibitors. The dose of TRIKAFTA should be reduced when used concomitantly with moderate or strong CYP3A inhibitors

Cataracts

Non-congenital lens opacities have been reported in pediatric patients treated with ivacaftor-containing regimens. Baseline and follow-up ophthalmological examinations are recommended in pediatric patients initiating treatment with TRIKAFTA

ADVERSE REACTIONS

Serious Adverse Reactions

Serious adverse reactions that occurred more frequently in patients treated with TRIKAFTA compared to placebo were rash (1% vs <1%) and influenza (1% vs 0%)

Most Common Adverse Reactions

The most common adverse reactions occurring in ≥5% of patients treated with TRIKAFTA and higher than placebo by ≥1% were headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, alanine aminotransferase increased, nasal congestion, blood creatine phosphokinase increased, aspartate aminotransferase increased, rhinorrhea, rhinitis, influenza, sinusitis, and blood bilirubin increased and constipation

USE IN SPECIFIC POPULATIONS

Pediatric Use

The safety and effectiveness of TRIKAFTA in patients with CF younger than 2 years of age have not been established

Please click here to see the full U.S. Prescribing Information, including Boxed WARNING for TRIKAFTA.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry’s top places to work, including 15 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Carmen Bozic, M.D., in this press release, statements regarding the eligible patient population for TRIKAFTA, expectations for access to TRIKAFTA for eligible patients, and statements regarding the potential benefits of TRIKAFTA. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include risks listed under the heading “Risk Factors” in Vertex’s annual report and in subsequent filings filed with the Securities and Exchange Commission and available through the company’s website at www.vrtx.com and www.sec.gov. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

View source version on businesswire.com: https://www.businesswire.com/news/home/20241220045992/en/

Vertex Pharmaceuticals Incorporated

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