UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
December
11, 2024
RESHAPE LIFESCIENCES
INC.
(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 Drive, Suite 110,
Irvine, CA |
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:
| x | 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 |
RSLS |
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 7.01 | Regulation FD Disclosure. |
Representatives of ReShape Lifesciences Inc. (the “Company”)
and Vyome Therapeutics, Inc. intend to make presentations at investor conferences and in other forums and these presentations may
include the information contained in Exhibit 99.1 attached to this Current Report on Form 8-K. A copy of the presentation slides
containing such information that may be disclosed by the Company is attached as Exhibit 99.1 to this report and the information set
forth therein is incorporated herein by reference and constitutes a part of this report.
The Company is furnishing the information contained in Exhibit 99.1
pursuant to Regulation FD and Item 7.01 of Form 8-K promulgated by the Securities and Exchange Commission (“SEC”). This
information shall not be deemed to be “filed” with the SEC for the 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, except as expressly set
forth by specific reference in such filing.
The information contained in Exhibit 99.1 is summary information
that is intended to be considered in the context of the Company’s SEC filings and other public announcements that the Company may
make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the
information contained in Exhibit 99.1, although it may do so from time to time as its management believes is warranted. Any such
updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
By filing this report and furnishing this information, the Company makes no admission as to the materiality of any information contained
in this report, including Exhibit 99.1.
Additional Information
In connection with the proposed merger with Vyome Therapeutics, Inc.
(the “Merge”) and sale of assets to Biorad Medisys of an affiliate thereof (the “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, 2023, which was filed with the SEC on April 1,
2024. 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.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
SIGNATURES
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.
| |
ENTEROMEDICS INC. |
| |
|
| |
By: |
/s/ Paul F. Hickey |
| |
|
Paul F. Hickey |
| |
|
Chief Executive Officer |
Dated: December 11, 2024
Exhibit 99.1
| Vyome
A US-India healthcare platform with clinical-stage immuno-inflammation assets
PENDING MERGER $RSLS TO $HIND
CORPORATE PRESENTATION DECEMBER 2024 |
| VYOME THERAPEUTICS, INC. (“Vyome”)
Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements as that term is
defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,”
“plan,” “potential,” “will,” and similar expressions, and are based on Vyome’s current beliefs and expectations. These forward-looking statements
include expectations regarding Vyome’s development of its drug candidates, including the timing of its clinical trials and regulatory
submissions. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical
trials, Vyome's reliance on third parties over which it may not always have full control, public health crises, epidemics and pandemics such as
the COVID-19 pandemic, including its impact on the timing of Vyome’s regulatory and research and development activities, Any forward-looking statements speak only as of the date of this presentation and are based on information available to Vyome as of the date of this
presentation. and Vyome assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new
information, future events or otherwise.
This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other
data about our industry. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such
estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which
we operate are necessarily subject to a high degree of uncertainty and risk. References to any publications, reports, surveys or articles prepared
by third parties should not be construed as depicting the complete findings of the entire publication, report, survey or article. The information in
any such publication, report, surveys or article is not incorporated by reference in this presentation.
2 |
| Vyome is building a 3-pillared healthcare
platform in the US-India innovation corridor
..We intend to list on Nasdaq via reverse merger with $RSLS under the ticker $HIND
We have invested nearly a decade and millions of
dollars to build a set of immuno-inflammatory
assets with several 12-24 month catalysts
DID YOU KNOW…
an ancient name
for India
$125B+ by 2028*
The immuno-inflammatory
market is expected to be
HIND Cambridge, MA HQ
Home to MIT and Harvard
3
*Allied Market Research – Anti-Inflammatory Therapeutics Market Review |
| At Vyome, we are passionate about transforming healthcare based on
world-class science & talent leveraging the US-India innovation corridor
Pharma Medical devices AI in healthcare
VYOME ($RSLS -> $HIND)
US INDIA
4
Vyome has a 3-pillar plan
and it intends to build, acquire, or partner with assets in each pillar |
| 1
2
3
Lower-risk biotech
assets with significant
catalysts in the next
12-24 months
Compelling
valuation based on
comparable
transactions; no debt
Powerful US-India
value capture
opportunity at the
optimal time
• Vyome has been developing Indian research
talent for a decade
• US-India relationship expected to grow significantly,
especially under the Trump-Modi governments,
leading to further capital markets and innovation
opportunities to capture
• Using known drugs for new unmet
indications (reduces risk)
• Going after indications that offer low regulatory bar
for approval (lower cash need)
• Large market opportunity with near-term catalysts
• A significant discount to a well-supported valuation
• No debt and clean capital structure
• At the intersection of several positive public
investor themes: biotech, innovation, global macro,
and emerging markets
Why
invest in
Vyome?
We believe we would be the first
venture-backed Indo-US
biopharma to list on the Nasdaq
5 |
| US-India special relationship and our positioning unlocks
significant capital markets and innovation opportunity
Ambassador Frank Wisner
Former US Ambassador to India &
Vyome Board Member to-be
Act on emerging health tech
opportunities through deal-making
Create cost arbitrage opportunities
for capital efficiency
Access capital markets looking for
plays on US/India innovation
6 |
| The current biotech assets offer a low-risk way to
unlock significant value over the next 12-24 months
Malignant Fungating Wound
Uveitis (steroid replacement)
Inflammatory acne*
$2.5B1
Market
size
$6M
Capital
required
2027
Potential value
inflection timeline
$2.6B2 $3M
$6.0B3 -
(pivotal data)
by 2032
2026
Phase 1
by 2028*
2025
Potential partnership deal
1 Based on 60-100K patients in U.S. (10% of ~600K cancer deaths per year in U.S.), and 1M patients globally (10% of ~10M advanced cancer patients). Based on average of 5-15% incidence of
cancer patients developing MFW (from The Microbiome, Malignant Fungating Wounds, and Palliative Care. Front. Cell. Infect. Microbiol., November 2019).
2. https://www.imarcgroup.com/uveitis-treatment-market
3. Total global acne market is forecasted to grow to $11.6B by 2028. https://www.marketdataforecast.com/market-reports/acne-medication-market
Inflammatory acne comprises over 50% of the acne market. https://www.verifiedmarketresearch.com/product/acne-medication-market/
Vyome
assets
7 |
| What is MFW?
MFW is a non-healing wound that occurs when cancer
breaks through the skin, causing infection and inflammation.
Patients suffer from extreme odor, pain, low self-esteem, and
social isolation.
MFW afflicts ~10%* of terminal cancer patients & generates
a strong odor that dramatically impairs quality of life and
care for a patient’s final years
No approved drug and thus potential orphan designation with faster track to development
Why is Vyome best-positioned?
Malignant Fungating Wound (MFW) is $1B/year unmet need with no
approved drug; the latest data on Vyome’s drug shows strong efficacy1
New data released in December 2024 shows a
75%+ reduction in odor and 50%+ increase in
quality of life
60,0002new patients/year
$10-20K3 lifetime value per patient US market opportunity
~$1B4/year
Vyome’s lead drug has the right mechanism
to treat the symptoms of MFW
The company will actively engage with the FDA
in 2025 as it plans an efficient pivotal trial
8
* The Microbiome, Malignant Fungating Wounds, and Palliative Care. Front. Cell. Infect.
Microbial., November 2019, EASED study (2023).
1. Investigator-initiated proof of concept phase 2 clinical study of VT-1953
2 The Microbiome, Malignant Fungating Wounds, and Palliative Care. Front. Cell. Infect. Microbial., November 2019, EASED study (2023)
https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21820
3. Average 60 days of treatment needed per patient: (From Kuge et al, Jpn J Clin Oncol, 1995). Total cost per patient: $200 ×60 Days= $12,000.. $200 per day
arrived at using the cost of an average gel tube cost and the amount of gel needed per day (Watanabe et al, Support Care Cancer. 2016; 24: 2583–2590),
assuming average MFW size of 57cm² (Pen and Dai et al,J of Int. Med Res, 2019 )..
4. 60K patients multiplied by an average of $16K pricing will come ot ~$1B |
| Vyome’s 2 biotech asset areas form a pipeline
addressing large unmet markets
Use an unmet orphan indication for low-risk and cost-efficient development to open larger opportunities
Our strategy
Pivotal studies in 2024
MFW
A DNA Gyr/MD2-TLR inhibitor
Potential FDA filing for MFW in 2027
Topical inflammatory diseases
~$15.8B
by 20322
Diabetic
foot ulcer
~$6B
by 20283
Inflammatory
Acne
1. https://www.skyquest.com/report/pressure-ulcers-treatment-market#:~:text=Global%20Pressure%20Ulcers%20Treatment%20Market%20Insights,period%20(2023%2D2030).
2. https://www.gminsights.com/industry-analysis/diabetic-ulcers-treatment-market
3 Total global acne market is forecasted to grow to $11.6B by 2028. https://www.marketdataforecast.com/market-reports/acne-medication-market
Inflammatory acne comprises over 50% of the acne market. https://www.verifiedmarketresearch.com/product/acne-medication-market/
~$9.5B
by 2030¹
Pressure
sores
~$8.73Bc
by 2033
Post-operative
cataract surgery
inflammation
IMPDH inhibitor
Uveitis
Potential FDA filing for uveitis in 2029
Steroid replacement for inflammatory ophthalmic diseases
~$13Bb
by 2030
Dry-eye-disease
~$4.7Ba
by 2030
Scleritis
Phase 1 in Q3 2026
~$2.3Bd
by 2031
Blepharitis
9
a. Market Research Future – Scleritis Market.
b. Fortune Business Insights – Dry Eye Syndrome Market
c. Future Market Insights – Post Operative Cataract Surgery Inflammation Market.
d. Business Research Insights – Blepharitis Market Report. |
| Vyome is focused on unlocking multiple value inflection points
from its core pharma assets over the next 12-24 months
MFW Program (anticipated milestones)
Uveitis Program (anticipated milestones)
Q1 2025 Q2/Q3 2025 Q1 2026 Q2 2026 Q3 2026 Q4 2026
IIT study
interim
read outs
Appointment
of CRO for
pivotal
study. Full
readout of IIT
study.
Pivotal trial
protocol
approved
by FDA
First patient
recruitment
25%
of patient
recruitment
completed
50%
of patient
recruitment
completed
75%
recruitment
completed
100%
recruitment
completed
Pivotal
study
Readouts
Q4 2024
Pre-IND
meeting, IIT
study start
Pre-IND
Tox
Tox, CMC IND filing First patient
recruitment
Last patient
Anticipated close recruitment
of Nasdaq
reverse-merger
Key catalysts
FDA
approval of
Phase 1 & 2
study
protocol
Q2 2026
Study
Readouts
Q1 2027
10 |
| Vyome has a compelling entry valuation, no debt,
and a narrative appealing to several types of investors
merger valuation
$120M
market comparables
valuation
$400M+
debt
$0M
Themes investors
allocate
4
Healthcare
India
Innovation
Global macro
11 |
| Notes: Stage / Phase, Modality, and Market Size refer to that of the Company’s Lead Program / Platform.
1) Vyome market capitalization is based on the implied value attributed to the Company in the reverse merger process.
Additional sources: Company websites, press releases, presentations, reports, and filings, FactSet market data as of 11/01/2024.
Lead Indication
Stage / Phase
Market Size
Program Stages
Market Cap
($MM)
Metastatic
Castrate Resistant
Prostate Cancer
Phase 1/2
~$13B
(2023)
3 clinical
0 pre-clinical
$134
Pulmonary
Arterial
Hypertension
Phase 2
~$7B
(2023)
1 clinical
0 pre-clinical
$198
Chronic
Granulomatous
Disease (CGD)
Phase 1/2
~1.3B
(2023)
1 clinical
5 pre-clinical
$529
Psoriasis
Phase 2
~$25B
(2023)
3 clinical
2 pre-clinical
$534
Severe Asthma,
CRSwNP, & COPD
Phase 2
~7.5B
(2023)
3 clinical
0 pre-clinical
$1,271
Myasthenia
Gravis & Thyroid
Eye Disease
Phase 3
~$4B
(2023)
4 clinical
1 pre-clinical
$4,314
~$3B
(Current)
2 clinical
1 pre-clinical
$120
Malignant fun
gating wound
Phase 2
(1)
Denotes aspirational comparable company
12
Public Comparables
Average Market Cap. of $419M (not including Immunovant)
Inflammation & Immunology Market Players |
| Notes: 1) Represents the market capitalizations on the trading day before it was announced that each respective company was to be acquired, unless otherwise noted. 2) Vyome market capitalization is based on the implied value attributed to the Company in the reverse merger process. 3) Landos Biopharma’s market capitalization represents
the aggregate transaction value of the Company’s pending acquisition by AbbVie at $20.42 per share in cash upon closing (~$137.5MM) plus one non-tradable contingent value right per share with a value of up to $11.14 per share (an additional ~$75MM), subject to the achievement of a clinical development milestone. 4) Escient
Pharmaceutical’s market capitalization represents the aggregate transaction cost that Incyte acquired the Company and its assets for plus its net cash remaining at the close of the transaction, subject to customary adjustments.
Additional sources: Company websites, press releases, presentations, reports, and filings, FactSet market data.
Inflammatory
bowel disease
Phase 2
~$30B
(Current)
1 clinical
0 pre-clinical
$5,419
Lead Indication
Stage / Phase
Market Size
Program Stages
Market Cap
($MM)
Atopic
dermatitis
Phase 2
~$9.3B
(2023)
2 clinical
0 pre-clinical
$750
~$3B
(Current)
2 clinical
1 pre-clinical
$120
Ulcerative
colitis
Phase 2
~$9B
(2031)
1 clinical
3 pre-clinical
$213
Inflammatory
bowel disease
Phase 2
~$30B
(Current)
1 clinical
0 pre-clinical
$1,595
Ulcerative colitis
Phase 3
~$9B
(2031)
4 clinical
1 pre-clinical
$3,063
Systemic lupus
erythematosus
Phase 2
~$3B
(2025)
2 clinical
2 pre-clinical
$2,553
Psoriasis
Phase 2
~$25B
(2023)
1 clinical
3 pre-clinical
$1,616
Malignant fun
gating wound
Phase 2
(1) (2) (3) (4)
Denotes private company at time of acquisition
13
Precedent M&A Comparables Acquired Inflammation & Immunology Market Players
Average Market Cap. of $2.8B (includes Morphic, DICE, Alpine, Arena, Prometheus) and
Transaction Price of $482M (includes Landos and Escient) |
| Vyome has an ideal team to execute its plan
Deep expertise in building and scaling companies; scientific thought leaders in drug development; extensive US-India crossborder experience
Dr. S Sengupta,Ph.D Venkat Nelabhotla Krishna Gupta Mohanjit Jolly
Co-Founder CEO & Co-Founder Chairman Board Member
Associate Prof. of Medicine,
Harvard Medical School
Expert in drug discovery
AIIMS Gold Medalist
Board member of Famygen,
acquired by Viatris for $300M
25+ yrs of business
experience
Led and scaled $1+ billion
companies in the healthcare &
life sciences space
Ex-CEO at Emami
$2.5B company
CEO of Remus Capital
Contrarian investor at Presto,
Allurion, EquipmentShare, Ginger
Experienced at McKinsey & JPM
2 BS degrees from MIT
Founding partner at Iron Pillar
Served as a Partner at Draper
Fisher Jurvetson for 9 years
Partner at Garage Tech Ventures
MBA from The Anderson
School, B.S. and M.S. from MIT
Board of The SETI Institute
14 |
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15 |
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