SEC 8-K filings with transcript text
Aug 25, 2026
2 ea030322801ex99-1.htm
Exhibit 99.1
Vyome Holdings Reports Second Quarter 2026 Results Highlighted By Advancement Of Lead
VT-1953 Program, Pipeline Expansion And Strong Balance Sheet
CAMBRIDGE, Mass., August 25, 2026 — Vyome Holdings, Inc. (“Vyome”), a clinical-stage biopharmaceutical company focused on immuno-inflammatory and rare disease conditions, today reports financial results for the second quarter ended June 30, 2026, and provides a corporate update.
Krishna Gupta, Chairman of Vyome Holdings, said, “Vyome continues to execute with focus and discipline across its development programs while maintaining a methodical and conservative approach to capital allocation. During the quarter, we advanced our lead VT-1953 program, broadened our pipeline through the Impetis agreement and continued to strengthen our intellectual property portfolio. With a strong balance sheet and disciplined capital structure, we believe Vyome is well positioned to pursue its development priorities and create long-term shareholder value.”
Venkat Nelabhotla, Vyome President and Chief Executive Officer, stated, “VT-1953 remains our lead priority. The Phase 2 data presented this year demonstrated statistically significant improvements in malodor, the patient-reported impact of malodor on daily life, and lesion pain, with no treatment-emergent adverse events reported. In March 2026, we submitted a pre-IND briefing package to the FDA that included our proposed pivotal clinical study strategy for the treatment of malodor and other symptoms associated with malignant fungating wounds. During the second quarter of 2026, the Company received the FDA’s written response on the proposed clinical development program. The Company is incorporating the FDA’s feedback, preparing the appropriate supporting package, and plans to continue its engagement with the FDA through a Type C meeting to further advance the clinical development program.
“At the same time, we are selectively building additional opportunities around our core immuno-inflammatory strategy. Our agreement with Impetis adds two selective JAK inhibitor assets and provides potential access to important autoimmune and inflammatory disease categories. We intend to advance these opportunities in a disciplined manner with non-dilutive methods while keeping VT-1953 as our primary development focus. Importantly, we continue to maintain a clean capital structure with no debt, no preferred stock, and no toxic financing instruments. We believe this combination of focused clinical execution, pipeline optionality, and financial discipline provides a strong foundation for long-term shareholder value,” concluded Mr. Nelabhotla.
Second Quarter 2026 and Recent Corporate Highlights
●In March 2026, submitted a pre-IND briefing package to the FDA including the proposed pivotal clinical study strategy for VT-1953; received the FDA’s written response on the proposed clinical development program during the second quarter is incorporating the FDA’s feedback, preparing the appropriate supporting package, and plans to continue its engagement with the FDA through a Type C meeting to further advance the clinical development program.
●Presented Phase 2 clinical data on lead candidate VT-1953 topical gel for treatment of malignant fungating wounds (MFW) at the American Association for Cancer Research (AACR), including:
oStatistically significant reduction in malodor (primary endpoint)
oStatistically significant improvement in patient-reported impact of malodor on daily life
oStatistically significant improvement in lesion pain
oNo treatment-emergent adverse events
●Signed agreement with Impetis Biosciences Limited (“Impetis’) to in-license two selective JAK inhibitor assets designed for higher selectivity to potentially treat autoimmune and inflammatory conditions
●Received a granted Chinese patent covering formulation and therapeutic use claims related to VB-1953 topical gel program for treating inflammatory acne
Financial Results for the Quarter Ended June 30, 2026
●Cash and cash equivalents were approximately $7.9 million as of June 30, 2026, compared with approximately $5.0 million as of December 31, 2025
●Total current assets were approximately $8.2 million as of June 30, 2026
●Total stockholders’ equity was approximately $7.3 million as of June 30, 2026
●Total operating expenses for the quarter ended June 30, 2026, were approximately $874,000, including approximately $507,000 in research and development expenses and approximately $365,000 in selling, general, and administrative expenses
●Net loss attributable to common shareholders for the quarter ended June 30, 2026, was approximately $720,000, or approximately $0.10 per basic and diluted share
Complete financial results can be found in the Company’s recent Quarterly Report on Form 10-Q available at sec.gov.
About Vyome Holdings, Inc.:
Vyome is building the world’s premier platform spannin
May 29, 2026
Nov 19, 2025
Nov 14, 2024
Aug 14, 2024
0001427570false00014275702024-08-142024-08-14
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 14, 2024
(Exact name of registrant as specified in its charter)
Delaware
1-37897
26-1828101
(State or other jurisdiction of incorporation)
(Commission File Number)
(I.R.S. Employer Identification Number)
18 Technology Dr, Suite 110,
Irvine, California
92618
(Address of principal executive offices)
(Zip Code)
(949) 429-6680
(Registrant’s telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of Class
Trading Symbol
Name of Exchange on which Registered
Common stock, $0.001 par value per share
The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 14, 2024, ReShape Lifesciences Inc. (the “Company”) issued a press release announcing its financial results for the three and six months ended June 30, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference
The information furnished herewith pursuant to Item 2.02 of this Current Report and in Exhibit 99.1 hereto is being “furnished” in accordance with General Instruction B.2 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits.
Exhibit No.
Description
99.1
Press Release dated August 14, 2024
104
Cover Page Interactive Data File (embedded with inline XBRL document)
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
By:
/s/ Tom Stankovich
Tom Stankovich
Chief Financial Officer
Dated: August 14, 2024
May 20, 2024
Apr 4, 2024
0001427570false00014275702024-04-012024-04-01
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 1, 2024
(Exact name of registrant as specified in its charter)
Delaware
1-37897
26-1828101
(State or other jurisdiction of incorporation)
(Commission File Number)
(I.R.S. Employer Identification Number)
18 Technology Dr, Suite 110,
Irvine, California
92618
(Address of principal executive offices)
(Zip Code)
(949) 429-6680
(Registrant’s telephone number, including area code)
1001 Calle Amanecer, Sand Clemente, California 92673
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of Class
Trading Symbol
Name of Exchange on which Registered
Common stock, $0.001 par value per share
The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On April 1, 2024, ReShape Lifesciences Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference
The information furnished herewith pursuant to Item 2.02 of this Current Report and in Exhibit 99.1 hereto is being “furnished” in accordance with General Instruction B.2 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits.
Exhibit No.
Description
99.1
Press Release dated April 1, 2024
104
Cover Page Interactive Data File (embedded with inline XBRL document)
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
By:
/s/ Tom Stankovich
Tom Stankovich
Chief Financial Officer
Dated: April 4, 2024
Nov 9, 2023
Aug 7, 2023
May 16, 2023
Nov 14, 2022
0001427570false00014275702022-11-142022-11-14
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 14, 2022
(Exact name of registrant as specified in its charter)
Delaware
1-37897
26-1828101
(State or other jurisdiction of incorporation)
(Commission File Number)
(I.R.S. Employer Identification Number)
1001 Calle Amanecer San Clemente, CA
92673
(Address of principal executive offices)
(Zip Code)
(949) 429-6680
(Registrant’s telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of Class
Trading Symbol
Name of Exchange on which Registered
Common stock, $0.001 par value per share
The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 14, 2022, ReShape Lifesciences Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference
The information furnished herewith pursuant to Item 2.02 of this Current Report and in Exhibit 99.1 hereto is being “furnished” in accordance with General Instruction B.2 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits.
Exhibit No.
Description
99.1
Press Release dated November 14, 2022
104
Cover Page Interactive Data File (embedded with inline XBRL document)
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
By:
/s/ Tom Stankovich
Tom Stankovich
Chief Financial Officer
Dated: November 14, 2022
Aug 16, 2022
2 rsls-20220815xex99d1.htm
Exhibit 99.1
ReShape Lifesciences™ Reports Second Quarter 2022 Financial Results and Provides Corporate Update
Second Quarter Revenues Increased 19% Sequentially, Indicating DTC Campaign Continues to Drive Demand for Lap-Band® Procedures
Conference Call to be Held at 4:30 pm ET Today
SAN CLEMENTE, Calif., August 15, 2022 -- ReShape Lifesciences Inc. (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health-solutions company, today reported financial and operating results for the second quarter ended June 30, 2022 and provided a corporate strategic update.
Second Quarter and Subsequent Highlights
●In July, received U.S. Food and Drug Administration (FDA) 510(k) clearance for the disposable Gastro Intestinal Balloon Indicator (GIBI HD™) calibration tube for use in gastric and bariatric procedures.
●In July, announced appointment of Paul F. Hickey, with over 25 years of medical device commercialization experience, as President and Chief Executive Officer. Board Chair, Dan W. Gladney, was appointed Executive Chair, supporting the company on strategic matters.
●In June, raised $2.5 million in gross proceeds through a warrant exercise agreement with an existing accredited investor, extending the company’s cash runway well into 2023.
●In June, announced that Vern Vincent, Senior Director, Global Professional Education and Medical Affairs, was recognized as this year’s Distinguished Industry Partner at the American Society for Metabolic and Bariatric Surgery (ASMBS) 2022 LEAD Gala and Awards.
●In June, facilitated the training of the next generation of bariatric surgeons on the Lap-Band® Program at the ASMBS annual conference.
●In May, signed an agreement with OpenLoop, an expert in full-stack virtual care delivery services, to provide a nationwide, physician-led, telehealth solution for reshapecare™, the company’s virtual weight loss solution.
“We have achieved a multitude of important milestones during the second quarter and more recently, strengthening our position as a market leader with our integrated portfolio of proven products and services that manage and treat obesity and associated metabolic disease,” stated Tom Stankovich, Chief Financial Officer of ReShape Lifesciences™. “The recent FDA approval for the line extension of disposable GIBI HD™ calibration tubes, which we expect to be rapidly adopted by surgeons given their ability to help better visualize the anatomy, making it easier to identify potential defects, should be launched into the market in September. Additionally, through our partnership with OpenLoop, we continue to expand the reach and awareness of reshapecare™, our proprietary, doctor prescribed, digital therapeutic weight loss and wellness program, reimbursed by major insurance plans. reshapecare™ is a critical component of treatment provided by ReShape,
through which we offer an effective and convenient virtual health coaching program for all weight loss patients including medical weight loss and pre- and post-surgical bariatric patients. We are also encouraged by the continued pace of inbound requests from bariatric surgeons for refresher courses on the Lap-Band® Program and the ability to train bariatric fellows, for the first time, at the ASMBS annual conference, in June. On the financial side, during the quarter, we continued to strengthen the balance sheet, grossing $2.5 million in proceeds from a warrant exercise, which, combined with an increase in revenues for the second half of 2022, extends our cash runway well into 2023. Taken together, these recent accomplishments bode well for future sales and revenue growth, going forward.”
Mr. Stankovich continued, “We are also fortunate to welcome Paul F. Hickey as ReShape’s newly appointed President and Chief Executive Officer. Paul’s extensive medical device and commercialization experience, and his deep understanding and familiarity with the obesity market and the Lap-Band®, will serve us well as he leads us through our continued growth trajectory.”
“I look forward to leading ReShape during such an exciting juncture, as we continue to execute on our goal of becoming the global leader of physician-led weight loss and metabolic health solutions, with a comprehensive, integrated slate of products and services,” stated Mr. Hickey. “The 19% increase in sequential revenues achieved in the second quarter reflects consumers’ belief in the safety and efficacy of the Lap-Band® as an effective and increasingly preferred method of managing obesity. It also reflects the growing ability of bariatric surgeons to proceed with these elective procedures, which were severely restricted earlier in the year due to the continued COVID-19 pandemic. While patients and providers navigate the typical six-month mandatory waiting period required by insurers for bariatric or weight loss procedures, including the Lap-Band®, we expect the positive trend in
May 23, 2022
2 rsls-20220523xex99d1.htm
Exhibit 99.1
ReShape Lifesciences™ Reports First Quarter 2022 Financial Results and Provides Corporate Update
March 2022 Revenues Exceeded January’s and February’s, Combined, Indicating DTC Campaign and Other Visibility Activities are Driving Significant Demand for Lap-Band® Procedures
Conference Call to be Held at 8:30 am ET Today
SAN CLEMENTE, Calif., May 23, 2022 -- ReShape Lifesciences Inc. (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health-solutions company, today reported financial and operating results for the first quarter ended March 31, 2022 and provided a corporate strategic update.
First Quarter Highlights and Accomplishments
●Ongoing, direct-to-consumer (DTC) marketing campaign continues to be successful in driving demand, filling surgeons’ patient pipeline for Lap-Band® procedures
●As the COVID-19 Omicron variant subsided in the latter part of the first quarter, March 2022 revenues eclipsed those of January and February, combined
●Robust trend in Lap-Band® sales continues, evidenced by weekly sales growth into April and May
●Vern Vincent, Senior Director, Global Professional Education and Medical Affairs, to be recognized as this year’s Distinguished Industry Partner at the American Society for Metabolic and Bariatric Surgery (ASMBS) 2022 LEAD Gala and Awards
●Following the presentation of the Lap-Band® Program and supportive reshapecare™ Virtual Health Coaching Platform to bariatric surgeons, allied health professionals and fellows, at the ASMBS Leadership Academy and re-UNITED Meeting in January, ReShape will facilitate the training of the next generation of bariatric surgeons at the ASMBS annual conference in June
“The emergence of the fast-spreading COVID-19 Omicron variant in late 2021 led to the closing of a significant number of bariatric centers, thus, severely limiting elective surgeries, nationwide, during the first few months of 2022, which deferred revenues during the quarter,” stated Bart Bandy, President and Chief Executive Officer of ReShape Lifesciences™. “That said, as the restrictions on elective procedures were subsequently lifted, we began to see a solid uptick in sales. We were particularly encouraged by our revenue generation in March, which eclipsed our sales in January and February, combined. Importantly, this positive revenue trend has extended into the second quarter and we expect that practices will work through any patient backlogs and the company will see continued sales growth throughout the year, buoyed by the success of our multi-tiered, DTC marketing campaign which is driving increased patient demand. This year, over 40 bariatric surgeons have approached us for recertification and we are receiving a steady flow of requests for refresher programs from existing accounts every week. We are extremely fortunate to have Vern Vincent, recipient of the ASMBS’ 2022
Distinguished Industry Partner Award, facilitating the training of these accounts and the next generation of bariatric surgeons, including Bariatric Fellows, on the benefits of the Lap-Band®.
“Given the level of renewed interest in the Lap-Band® from key industry organizations, bariatric surgeons and consumers, alike, we are enthusiastic about the road ahead. Understanding that the four-to-six-month mandatory waiting period required by insurers for bariatric or weight loss procedures, including the Lap-Band®, represents an anticipated interval between early patient engagement and scheduled procedures, we are just at the cusp of reaping the benefits of our DTC marketing campaign, which we plan to expand throughout the year by integrating targeted digital media marketing with our current television and print campaign. We are optimistic that the upward trend in sales we are experiencing will continue as we expand visibility and demand for the Lap-Band®.”
First Quarter Ended March 31, 2022 Financial and Operating Results
Revenue totaled $2.4 million for the three months ended March 31, 2022, which represents a contraction of 24.2%, or $0.8 million compared to the same period in 2021. The decline is primarily attributable to the emergence, in late 2021 of the fast-spreading Omicron variant of COVID-19, resulting in a marked rise in global cases, causing a significant number of bariatric centers to close from December 2021 through February 2022. During March 2022, the Company experienced a significant increase in revenue compared to January and February 2022, as the Omicron variant began to subside. The Company expects its revenue will continue to increase through the remainder of 2022, as it has witnessed a significant growth in web traffic and doctor consultations, attributable to the DTC marketing campaign the Company launched during the fourth quarter of 2021.
Gross Profit for the three months ended March 31, 2022 was $1.2 million, compared to $2.3 million for the same period in 202
Mar 28, 2022
Mar 22, 2022
Mar 17, 2022
Nov 12, 2021
Aug 16, 2021
0001427570false00014275702021-08-162021-08-16
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 16, 2021
(Exact name of registrant as specified in its charter)
Delaware
1-37897
26-1828101
(State or other jurisdiction of incorporation)
(Commission File Number)
(I.R.S. Employer Identification Number)
1001 Calle Amanecer San Clemente, CA
92673
(Address of principal executive offices)
(Zip Code)
(949) 429-6680
(Registrant’s telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of Class
Trading Symbol
Name of Exchange on which Registered
Common stock, $0.001 par value per share
The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 16, 2021 ReShape Lifesciences Inc. (the “Company”) issued a press release announcing its financial results for the three and six months ended June 30, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information furnished herewith pursuant to Item 2.02 of this Current Report and in Exhibit 99.1 hereto is being “furnished” in accordance with General Instruction B.2 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits.
Exhibit No.
Description
99.1
Press Release dated August 16, 2021
104
Cover Page Interactive Data File (embedded with inline XBRL document
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
By:
/s/ Tom Stankovich
Tom Stankovich
Chief Financial Officer
Dated: August 16, 2021
May 12, 2021
2 tmb-20210512xex99d1.htm
Exhibit 99.1
Obalon Announces First Quarter 2021 Financial Results
SAN DIEGO, CA MAY 12, 2021 (GLOBE NEWSWIRE) -- Obalon Therapeutics, Inc. (NASDAQ:OBLN), a vertically integrated medical technology company with the first and only FDA-approved swallowable, gas-filled intragastric balloon system for the treatment of obesity, today announced its financial results for the first quarter ended March 31, 2021. On January 19, 2020 the Company signed a definitive agreement for a merger with ReShape Lifesciences Inc.
Financial results for the first quarter of 2021
Revenue for the first quarter of 2021 was none, compared to $0.8 million for the first quarter of 2020, with the decrease primarily due to the suspension of operations in the second quarter of 2020. Net loss for the first quarter of 2021 was $4.2 million, compared to $5.3 million for the first quarter of 2020. Net loss per share for the first quarter of 2021 was $0.44, compared to $0.68 for the first quarter of 2020.
Cost of revenue was none for the first quarter of 2021, down from $0.5 million for the first quarter of 2020. Gross profit for the first quarter of 2021 was none compared to a gross profit of $0.2 million for the first quarter of 2020.
Research and Development expense for the first quarter of 2021 totaled $0.1 million, down from $1.3 million for the first quarter of 2020. Selling, General and Administrative expense increased to $4.1 million for the first quarter of 2021, compared to $3.9 million for the first quarter of 2020.
Operating loss for the first quarter of 2021 was $4.2 million, down from a loss of $4.9 million for the first quarter of 2020.
As of March 31, 2021, the Company had cash and cash equivalents of $9.0 million and $0.4 million of debt related to its Payroll Protection Program loan.
About Obalon Therapeutics, Inc.
Obalon Therapeutics, Inc. (NASDAQ:OBLN) is a San Diego-based company focused on developing and commercializing novel technologies for weight loss.
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements that are not purely historical regarding Obalon’s or its management’s intentions, beliefs, expectations and strategies for the future, including those related to new products and their potential benefits. All forward-looking statements and reasons why results might differ included in this press release are made as of the date of this release, based on information currently available to Obalon, deal with future events, are subject to various risks and uncertainties, and actual results could differ materially from those anticipated in those forward looking statements. The risks and uncertainties that may cause actual results to differ materially from Obalon’s current expectations are more fully described in Obalon’s annual report on Form 10-K for the fiscal year ended December 31, 2020 and its quarterly report on Form 10-Q for the fiscal quarter ended March 31, 2021, and its other reports, each as filed with the Securities and Exchange Commission. Except as required by law, Obalon assumes no obligation to update any such forward-looking statement after the date of this report or to conform these forward-looking statements to actual results.
1
(unaudited)
(in thousands, except shares and per share data)
Three Months ended March 31,
2021
2020
Revenue
$
—
$
780
Cost of revenue
—
541
Gross profit
—
239
Operating expenses:
Research and development
112
1,257
Selling, general and administrative
4,056
3,893
Total operating expenses
4,168
5,150
Loss from operations
(4,168)
(4,911)
Interest income (expense), net
1
35
Other expense
—
(385)
Net loss
(4,167)
(5,261)
Net loss and comprehensive loss
$
(4,167)
$
(5,261)
Net loss per share, basic and diluted
$
(0.44)
$
(0.68)
Weighted-average common shares outstanding, basic and diluted
9,444,241
7,725,205
2
(in thousands, except shares and par value data)
March 31,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
8,972
$
3,905
Other current assets
3,822
3,930
Total current assets
12,794
7,835
Lease right-of-use assets
421
521
Property and equipment, net
891
957
Clinical-use assets
1,304
1,304
Other long-term assets
1,933
—
Total assets
$
17,343
$
10,617
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
5
Mar 12, 2021
2 tmb-20210312xex99d1.htm
Exhibit 99.1
Obalon Announces Fourth Quarter and Full Year 2020 Financial Results
SAN DIEGO, CA March 12, 2021 (GLOBE NEWSWIRE) -- Obalon Therapeutics, Inc. (NASDAQ:OBLN), a vertically integrated medical technology company with the first and only FDA-approved swallowable, gas-filled intragastric balloon system for the treatment of obesity, today announced its financial results for the fourth quarter and full year ended December 31, 2020. On November 10, 2020, the Company signed a non-binding term sheet for merger with ReShape Lifesciences Inc. and, on January 20, 2021, announced that a definitive agreement had been signed on January 19, 2020 for a merger with ReShape Lifesciences Inc.
Financial results for the fourth quarter of 2020
Revenue for the fourth quarter of 2020 was $0.1 million, compared to $0.8 million for the fourth quarter of 2019, with the decrease primarily due to the suspension of operations in the second quarter of 2020. Net loss for the fourth quarter of 2020 was $1.3 million, compared to $4.9 million for the fourth quarter of 2019. Net loss per share for the fourth quarter of 2020 was $0.17, compared to $0.64 for the fourth quarter of 2019.
Cost of revenue was $0 for the fourth quarter of 2020, down from $0.6 million for the fourth quarter of 2019. Gross profit for the fourth quarter of 2020 was $0.1 million compared to $0.2 million for the fourth quarter of 2019.
Research and Development expense for the fourth quarter of 2020 totaled $0.2 million, down from $1.5 million for the fourth quarter of 2019. Selling, General and Administrative expense decreased to $1.2 million for the fourth quarter of 2020, compared to $3.6 million for the fourth quarter of 2019.
Operating loss for the fourth quarter of 2020 was $1.4 million, down from a loss of $5.0 million for the fourth quarter of 2019.
As of December 31, 2020, the Company had cash and cash equivalents of $3.9 million and $0.4 million of debt related to its Payroll Protection Program loan.
Financial results for the full year of 2020
Revenue for the full year of 2020 was $1.6 million, compared to $3.3 million for the full year of 2019, with the decrease primarily due to the suspension of operations in the second quarter of 2020. Net loss for the full year of 2020 was $12.3 million, compared to $23.7 million for the full year of 2019. Net loss per share for the full year of 2020 was $1.59, compared to $5.03 for the full year of 2019.
Cost of revenue was $1.0 million for the full year of 2020, down from $3.0 million for the full year of 2019. Gross profit for the full year of 2020 was $0.6 million compared to $0.3 million for the full year of 2019.
Research and Development expense for the full year of 2020 totaled $2.5 million, down from $6.9 million for the full year of 2019. Selling, General and Administrative expense decreased to $8.8 million for the full year of 2020, compared to $16.7 million for the full year of 2019. Operating loss for the full year of 2020 was $12.0 million, down from a loss of $23.2 million for the full year of 2019.
Subsequent Events
From January 1, 2021 through March 2, 2021, the Company’s warrant holders covering 2.3 million shares exercised the warrants and common stock was issued in exchange for proceeds of $9.5 million.
About Obalon Therapeutics, Inc. Obalon Therapeutics, Inc. (NASDAQ:OBLN) is a San Diego-based company focused on developing and commercializing novel technologies for weight loss.
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements that are not purely historical regarding Obalon’s or its management’s intentions, beliefs, expectations and strategies for the future, including those related to the potential merger with ReShape Lifesciences Inc. All forward-looking statements and reasons why results might differ included in this press release are made as of the date of this release, based on information currently available to Obalon, deal with future events, are subject to various risks and uncertainties, and actual results could differ materially from those anticipated in those forward looking statements. The risks and uncertainties that may cause actual results to differ materially from Obalon’s current expectations are more fully described in Obalon’s annual report on Form 10-K for the period ended December 31, 2020, and its other reports, each as filed with the Securities and Exchange Commission. Except as required by law, Obalon assumes no obligation to update any such forward-looking statement after the date of this report or to conform these forward-looking statements to actual results.
(unaudited)
(in thousands, except shares and per share data)
Three Months Ended December 31,
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