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Merger Agreement With Vyome Therapeutics and Asset Purchase Agreement with Biorad Medisys Progress Towards Completion
IRVINE, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences Inc. (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health-solutions company, today reported financial results for the first quarter ended March 31, 2025 and provided a corporate strategic update.
First Quarter 2025 and Subsequent Highlights
- May 2025: Effected a 1-for-25 reverse stock split of the company's common stock, which was effective for trading purposes upon the commencement of trading on May 9, 2025.
- May 2025: Presented pre-clinical data on its proprietary Diabetes Neuromodulation device in a poster presentation at the 12th Annual Minnesota Neuromodulation Symposium. Jonathan J. Waataja, Ph.D., Director of Research at ReShape Lifesciences®, presented the data in a poster presentation entitled, Stimulation of the Posterior Sub-Diaphragmatic Vagal Trunk Reverses Insulin-Induced Severe Hypoglycemia in a Swine Model of Type 1 Diabetes Mellitus.
- April 2025: Received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 18/241,151, entitled, "Intragastric Device.” When issued, the patent will cover claims for an intragastric balloon system, comprising a swallowable capsule with a self-sealing fill valve and a degradable release valve designed to deflate and open the valve around three months after inflation with saline liquid, and configured for natural excretion after deflation, among other claim features. Once issued, the patent will provide protection into at least January 2031, without accounting for a potential Patent Term Extension (PTE).
- April 2025: Received a Notice of Allowance from the USPTO for patent application 18/069,689, entitled, "High-Frequency Low Duty Cycle Patterns for Neural Regulation.” When issued, the patent will provide protection until August 4, 2037. The Diabetes Neuromodulation system leverages its proprietary vagus nerve block (vBloc™) technology platform, along with vagus nerve stimulation, to treat Type 2 diabetes, a prominent disorder linked with obesity.
- April 2025: Announced an agreement with Haifa, Israel-based Motion Informatics to exclusively import and distribute their next-generation neuromuscular rehabilitation devices in the U.S. The flagship product, the Stimel-03, was showcased at the American Occupational Therapy Association 2025 Annual Conference and Expo, held April 3-5, 2025, in Philadelphia, PA.
- March 2025: Received a Notice of Allowance from the USPTO for patent application 17/046,677, entitled, "Simultaneous Multi-Site Vagus Nerve Modulation for Improved Glycemic Control System and Methods.” When issued, the patent will provide protection until April 12, 2039.
- February 2025: Signed a distribution agreement with Liaison Medical for ReShape's next generation, enhanced Lap-Band® 2.0 FLEX and Tubing Kit, in Canada.
- February 2025: Closed an upsized $6.0 million public offering.
- February 2025: Granted a key international patent from the State of Israel Patent Office for the company's Diabetes Neuromodulation technology. Patent Number 277949, entitled, "Simultaneous Multi-Site Vagus Nerve Modulation for Improved Glycemic Control Systems and Methods,” will provide protection until December 4, 2039.
- January 2025: Provided an update on the definitive merger agreement under which ReShape and Vyome will combine in an all-stock transaction. The combined company will focus on advancing the development of Vyome's immuno-inflammatory assets and on identifying additional opportunities between the world-class Indian innovation corridor and the U.S. market. ReShape also provided an update on the asset purchase agreement with Biorad Medisys.
On July 8, 2024, ReShape Lifesciences Inc. entered into a definitive merger agreement with Vyome, under which ReShape and Vyome will combine in an all-stock transaction. At the closing of the merger, ReShape will be renamed Vyome Holdings, Inc. and expects to trade under the Nasdaq ticker symbol "HIND," representing the company's alignment with the U.S.-India relationship. The board of directors of the combined company will be comprised of six directors designated by Vyome and one director designated by ReShape, and executive management of the combined company will consist of Vyome's executive officers.
Simultaneously with the execution of the merger agreement, ReShape entered into an asset purchase agreement with Biorad, which was amended on April 25, 2025, which is party to a previously disclosed exclusive license agreement with ReShape for ReShape's Obalon® Gastric Balloon System. Pursuant to the asset purchase agreement, ReShape will sell substantially all of its assets to Biorad (or an affiliate thereof), including ReShape's Lap-Band® System, Obalon® Gastric Balloon System and the Diabetes Bloc-Stim Neuromodulation™ (DBSN™) System (but excluding cash), and Biorad will assume substantially all of ReShape's liabilities. The cash purchase price under the asset purchase agreement will count toward ReShape's net cash for purposes of determining the post-merger ownership allocation between ReShape and Vyome stockholders under the merger agreement.
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"The first quarter of 2025 and the months that followed have marked a period of strong momentum for ReShape, both operationally and strategically,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences®. "We continued to expand access to our portfolio of physician-led, minimally invasive weight-loss solutions, highlighted by a new distribution agreement with Liaison Medical to launch our enhanced Lap-Band® 2.0 FLEX to the Canadian market. This partnership, following our Health Canada approval in late 2024, is a significant milestone in delivering effective, less-invasive alternatives to bariatric surgery to broader global patient base. We also expanded our product portfolio through an exclusive U.S. distribution agreement for Motion Informatics' next-generation neuromuscular rehabilitation devices, further broadening our portfolio of innovative medical devices.
"At the same time, we strengthened our leadership in diabetes innovation by presenting promising pre-clinical data on our Diabetes Neuromodulation device at the 12th Annual Minnesota Neuromodulation Symposium, in a featured poster presentation, showcasing the potential of our proprietary vagus neuromodulation technology platform. Further strengthening our position, the Diabetes Neuromodulation system received significant intellectual property protection, including multiple Notices of Allowance from the USPTO and a pivotal international patent from the Israel Patent Office. These patents extend our intellectual property coverage through at least 2039, underscoring our leadership in addressing both Type 1 and Type 2 diabetes through neuromodulation and its close association with obesity. We also received a Notice of Allowance for our intragastric device patent, which covers a next-generation, self-deflating, swallowable balloon system-an important addition to our metabolic health platform. As our patent portfolio grows, we remain committed to protecting our position and, when appropriate, will pursue strategic, non-dilutive funding to support this objective.”
Mr. Hickey concluded, "The successful completion of our $6.0 million public offering in February strengthens our financial foundation as we continue to execute on our growth initiatives. Finally, we are making continued progress toward finalizing our merger with Vyome and the asset sale to Biorad Medisys. The S-4 was recently declared effective and we are working to set the record date in the near future. Our Board unanimously supports this transformative transaction, which we believe will unlock long-term value for shareholders and drive accelerated growth for the newly combined company."
First Quarter Ended March 31, 2025, Financial and Operating Results
Revenue $1.1 million for the three months ended March 31, 2025, which represents a contraction of 42.7%, or $0.8 million compared to the same period in 2024. This primarily resulted from a decrease in sales volume primarily due to GLP-1 pharmaceutical weight-loss alternatives as well as a temporary pause in DTC marketing programs.
Gross Profit for the three months ended March 31, 2025 and 2024, was $0.7 million, and $1.2 million, respectively. Gross profit as a percentage of total revenue for the three months ended March 31, 2025, was 61.2% compared to 59.9% for the same period in 2024. The increase in gross profit percentage is due to the reduction in overhead related costs, primarily payroll.
Sales and Marketing Expenses for the three months ended March 31, 2025, decreased by $0.5 million, or 48.1%, to $0.5 million, compared to $1.0 million for the same period in 2024. The decrease is primarily due to a decrease in advertising and marketing expenses, including consulting and professional marketing services.
General and Administrative Expenses for the three months ended March 31, 2025, decreased by approximately $0.3 million, or 13.1%, to $1.6 million, compared to $1.9 million for the same period in 2024. The decrease is primarily due to a $0.4 million reduction in general legal, audit, and other professional fees, as the Company reduced its reliance on consultants and professional services to conserve cash.
Research and Development Expenses for the three months ended March 31, 2025, decreased by $0.1 million, or 24.8% to $0.4 million, compared to approximately $0.5 million for the same period in the prior year.
Transaction Costs for the three months ended March 31, 2025, were $0.4 million. These expenses primarily consisted of legal and audit-related fees incurred in connection with the Company's pending merger and asset sale.
Gain on changes in fair value of liability warrants for the three months ended March 31, 2025 of $3.7 million is related to the change in fair value of liability-classified warrants issued in connection with the Company's February 2025 public offering. The gain recognized in the quarter reflects the decrease in the fair value of the warrants between the issuance date and March 31, 2025.
Cash and Cash Equivalents as of March 31, 2025 were $2.6 million, including restricted cash.
About ReShape Lifesciences®
ReShape Lifesciences® is America's premier weight loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. The FDA-approved Lap-Band® System provides minimally invasive, long-term treatment of obesity and is an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. The investigational vagal neuromodulation system utilizes a proprietary vagus nerve block and stimulation technology platform for the treatment of type 2 diabetes and metabolic disorders. The Obalon® balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss. For more information, please visit www.reshapelifesciences.com.
Non-GAAP Disclosures
In addition to the financial information prepared in conformity with GAAP, we provide certain historical non-GAAP financial information. Management believes that these non-GAAP financial measures assist investors in making comparisons of period-to-period operating results.
Management believes that the presentation of this non-GAAP financial information provides investors with greater transparency and facilitates comparison of operating results across a broad spectrum of companies with varying capital structures, compensation strategies, and amortization methods, which provides a more complete understanding of our financial performance, competitive position, and prospects for the future. However, the non-GAAP financial measures presented in this release have certain limitations in that they do not reflect all of the costs associated with the operations of our business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by the company may be different from similarly named non-GAAP financial measures used by other companies.
Adjusted EBITDA
Management uses Adjusted EBITDA in its evaluation of the company's core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Adjusted EBITDA is defined as net loss before interest, taxes, depreciation and amortization, stock-based compensation, and other one-time costs. Management uses Adjusted EBITDA in its evaluation of the company's core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by the company may be different from similarly named non-GAAP financial measures used by other companies.
Additional Information
In connection with the proposed Merger and Asset Sale, ReShape plans to file with the Securities and Exchange Commission (the "SEC”) and mail or otherwise provide to its stockholders a joint proxy statement/prospectus and other relevant documents in connection with the proposed Merger and Asset Sale. Before making a voting decision, ReShape's stockholders are urged to read the joint proxy statement/prospectus and any other documents filed by ReShape with the SEC in connection with the proposed Merger and Asset Sale or incorporated by reference therein carefully and in their entirety when they become available because they will contain important information about ReShape, Vyome and the proposed transactions. Investors and stockholders may obtain a free copy of these materials (when they are available) and other documents filed by ReShape with the SEC at the SEC's website at www.sec.gov, at ReShape's website at www.reshapelifesciences.com, or by sending a written request to ReShape at 18 Technology Drive, Suite 110, Irvine, California 92618, Attention: Corporate Secretary.
Participants in the Solicitation
This document does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities of ReShape and its directors, executive officers and certain other members of management and employees may be deemed to be participants in soliciting proxies from its stockholders in connection with the proposed Merger and Asset Sale. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of ReShape's stockholders in connection with the proposed Merger and Asset Sale will be set forth in joint proxy statement/prospectus if and when it is filed with the SEC by ReShape and Vyome. Security holders may obtain information regarding the names, affiliations and interests of ReShape's directors and officers in ReShape's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on April 4, 2025. To the extent the holdings of ReShape securities by ReShape's directors and executive officers have changed since the amounts set forth in ReShape's proxy statement for its most recent annual meeting of stockholders, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding these individuals and any direct or indirect interests they may have in the proposed Merger and Asset Sale will be set forth in the joint proxy statement/prospectus when and if it is filed with the SEC in connection with the proposed Merger and Asset Sale, at ReShape's website at www.reshapelifesciences.com.
Forward-Looking Statements
Certain statements contained in this filing may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Merger and Asset Sale and the ability to consummate the Merger and Asset Sale. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes,” "plans,” "anticipates,” "projects,” "estimates,” "expects,” "intends,” "strategy,” "future,” "opportunity,” "may,” "will,” "should,” "could,” "potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and ReShape undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (1) ReShape may be unable to obtain stockholder approval as required for the proposed Merger and Asset Sale; (2) conditions to the closing of the Merger or Asset Sale may not be satisfied; (3) the Merger and Asset Sale may involve unexpected costs, liabilities or delays; (4) ReShape's business may suffer as a result of uncertainty surrounding the Merger and Asset Sale; (5) the outcome of any legal proceedings related to the Merger or Asset Sale; (6) ReShape may be adversely affected by other economic, business, and/or competitive factors; (7) the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement or Asset Purchase Agreement; (8) the effect of the announcement of the Merger and Asset Purchase Agreement on the ability of ReShape to retain key personnel and maintain relationships with customers, suppliers and others with whom ReShape does business, or on ReShape's operating results and business generally; and (9) other risks to consummation of the Merger and Asset Sale, including the risk that the Merger and Asset Sale will not be consummated within the expected time period or at all. Additional factors that may affect the future results of ReShape are set forth in its filings with the SEC, including ReShape's most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC's website at www.sec.gov, specifically under the heading "Risk Factors.” The risks and uncertainties described above and in ReShape's most recent Annual Report on Form 10-K are not exclusive and further information concerning ReShape and its business, including factors that potentially could materially affect its business, financial condition or operating results, may emerge from time to time. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that ReShape files from time to time with the SEC. The forward-looking statements in these materials speak only as of the date of these materials. Except as required by law, ReShape assumes no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
CONTACTS:
ReShape Lifesciences Contact:
Paul F. Hickey
President and Chief Executive Officer
949-276-7223
Investor Relations Contact:
Michael Miller
(917)-633-6086
RESHAPE LIFESCIENCES INC. Condensed Consolidated Balance Sheets (in thousands, except share amounts) (unaudited) | ||||||||
March 31, | December 31, | |||||||
2025 | 2024 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 2,515 | $ | 693 | ||||
Restricted cash | 100 | 100 | ||||||
Accounts and other receivables (net of allowance for doubtful accounts of $871 and $918 respectively) | 734 | 987 | ||||||
Inventory | 2,532 | 2,460 | ||||||
Prepaid expenses and other current assets | 414 | 348 | ||||||
Total current assets | 6,295 | 4,588 | ||||||
Property and equipment, net | 34 | 38 | ||||||
Operating lease right-of-use assets | 99 | 116 | ||||||
Deferred tax asset, net | 26 | 22 | ||||||
Other assets | 29 | 29 | ||||||
Total assets | $ | 6,483 | $ | 4,793 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,686 | $ | 2,208 | ||||
Accrued and other liabilities | 2,158 | 1,688 | ||||||
Warranty liability, current | 163 | 163 | ||||||
Debt, current portion | - | 811 | ||||||
Operating lease liabilities, current | 116 | 115 | ||||||
Total current liabilities | 4,123 | 4,985 | ||||||
Operating lease liabilities, noncurrent | 14 | 41 | ||||||
Common stock warrant liability | 1,116 | 20 | ||||||
Total liabilities | 5,253 | 5,046 | ||||||
Commitments and contingencies (Note 2 and Note 10) | ||||||||
Stockholders' equity (deficit): | ||||||||
Preferred stock, 10,000,000 shares authorized: | ||||||||
Series C convertible preferred stock, $0.001 par value; 95,388 shares issued and outstanding at March 31, 2025 and December 31, 2024 | - | - | ||||||
Common stock, $0.001 par value; 300,000,000 shares authorized at March 31, 2025 and December 31, 2024; 133,081 and 29,235 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively | - | - | ||||||
Additional paid-in capital | 642,570 | 642,555 | ||||||
Accumulated deficit | (641,230 | ) | (642,704 | ) | ||||
Accumulated other comprehensive loss | (110 | ) | (104 | ) | ||||
Total stockholders' equity (deficit) | 1,230 | (253 | ) | |||||
Total liabilities and stockholders' equity (deficit) | $ | 6,483 | $ | 4,793 | ||||
RESHAPE LIFESCIENCES INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (unaudited) | ||||||||
Three Months Ended March 31, | ||||||||
2025 | 2024 | |||||||
Revenue | $ | 1,113 | $ | 1,944 | ||||
Cost of revenue | 432 | 779 | ||||||
Gross profit | 681 | 1,165 | ||||||
Operating expenses: | ||||||||
Sales and marketing | 529 | 1,019 | ||||||
General and administrative | 1,627 | 1,872 | ||||||
Research and development | 364 | 484 | ||||||
Transaction costs | 367 | - | ||||||
Total operating expenses | 2,887 | 3,375 | ||||||
Operating loss | (2,206 | ) | (2,210 | ) | ||||
Other expense (income), net: | ||||||||
Interest expense (income), net | 40 | (9 | ) | |||||
Gain on changes in fair value of liability warrants | (3,661 | ) | (21 | ) | ||||
Gain on extinguishment of debt | (24 | ) | - | |||||
Loss on foreign currency exchange, net | 12 | 24 |
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