UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
☑
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2024
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ____ to ____
Commission
File No. 000-51783
Dror
Ortho-Design, Inc.
(Exact
name of registrant as specified in its charter)
Delaware | | 85-0461778 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification Number) |
| | |
Shatner Street 3 Jerusalem, Israel | | N/A |
(Address of principal executive office) | | (Zip Code) |
Registrant’s
telephone number, including area code: +972 (0)74-700-6700
N/A
(Former
name or former address, if changed since last report) |
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class | | Trading Symbol | | Name of each exchange on which registered |
None | | None | | None |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically and every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant has been required to submit
and post such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
| | | |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| | | |
| | 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. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of shares outstanding of the registrant’s
common stock, par value $0.0001 per share, as of November 14, 2024 was 956,997,116 shares.
Dror
Ortho-Design, Inc.
Quarter
Ended September 30, 2024
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
Item
1. Condensed Consolidated Financial Statements
DROR
ORTHO-DESIGN, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(U.S.
dollars)
| |
September 30, 2024 | | |
December 31, 2023 | |
| |
Unaudited | | |
Audited | |
Assets | |
| | |
| |
Current Assets: | |
| | |
| |
Cash | |
$ | 1,143,269 | | |
$ | 3,347,843 | |
Other receivables and prepaid expenses | |
| 98,830 | | |
| 114,100 | |
Total Current Assets | |
| 1,242,099 | | |
| 3,461,943 | |
| |
| | | |
| | |
Noncurrent Assets: | |
| | | |
| | |
Property and equipment at cost, net of accumulated depreciation | |
| 25,377 | | |
| 2,328 | |
Total Assets | |
| 1,267,476 | | |
| 3,464,271 | |
| |
| | | |
| | |
Liabilities And Stockholders’ Equity | |
| | | |
| | |
| |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 84,680 | | |
$ | 106,833 | |
Accrued expenses and other payables | |
| 283,208 | | |
| 190,271 | |
Registration Rights Agreement liability | |
| 520,000 | | |
| — | |
Total Current Liabilities | |
| 887,888 | | |
| 297,104 | |
| |
| | | |
| | |
Noncurrent Liabilities: | |
| | | |
| | |
Accrued severance | |
| 5,126 | | |
| 5,243 | |
Total Liabilities | |
| 893,014 | | |
| 302,347 | |
| |
| | | |
| | |
Commitments and Contingencies (Note 4) | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ Equity | |
| | | |
| | |
Preferred A Stock, $0.0001 par value, 12,500,000 shares authorized; 5,847,937 and 10,463,363 shares outstanding at September 30, 2024 and December 31, 2023, respectively | |
| 585 | | |
| 1,047 | |
Common stock, $0.0001 par value; 3,254,475,740 and 500,000,000 shares authorized; 956,997,116 and 495,454,546 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively | |
| 95,699 | | |
| 49,545 | |
Additional paid-in capital | |
| 18,651,071 | | |
| 16,842,037 | |
Accumulated deficit | |
| (18,372,893 | ) | |
| (13,730,705 | ) |
Total Stockholders’ Equity | |
| 374,462 | | |
| 3,161,924 | |
Total Liabilities and Stockholders’ Equity | |
$ | 1,267,476 | | |
$ | 3,464,271 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
DROR
ORTHO-DESIGN, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S.
dollars, except share and per share amounts)
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
Unaudited | | |
Unaudited | |
Operating Expenses | |
| | |
| | |
| | |
| |
Research and development | |
| 451,030 | | |
| 325,360 | | |
| 1,213,903 | | |
| 764,721 | |
General and administrative expenses | |
| 307,593 | | |
| 227,484 | | |
| 1,026,431 | | |
| 543,929 | |
Share-based compensation | |
| 543,101 | | |
| 2,516 | | |
| 1,854,726 | | |
| 12,636 | |
Total Operating Expenses | |
| 1,301,724 | | |
| 555,360 | | |
| 4,095,060 | | |
| 1,321,286 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (1,301,724 | ) | |
| (555,360 | ) | |
| (4,095,060 | ) | |
| (1,321,286 | ) |
| |
| | | |
| | | |
| | | |
| | |
Financial income (expense), net | |
| (5,211 | ) | |
| 1,824 | | |
| (27,128 | ) | |
| 16,364 | |
Registration Rights Agreement expense | |
| (520,000 | ) | |
| — | | |
| (520,000 | ) | |
| — | |
Total other income (expense) | |
| (525,211 | ) | |
| 1,824 | | |
| (547,128 | ) | |
| 16,364 | |
| |
| | | |
| | | |
| | | |
| | |
Loss before provision for income taxes | |
| (1,826,935 | ) | |
| (553,536 | ) | |
| (4,642,188 | ) | |
| (1,304,922 | ) |
Provision for income taxes | |
| — | | |
| — | | |
| — | | |
| — | |
Net loss | |
| (1,826,935 | ) | |
| (553,536 | ) | |
| (4,642,188 | ) | |
| (1,304,922 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share | |
| | | |
| | | |
| | | |
| | |
Basic and Diluted | |
| (0.00 | ) | |
| (0.00 | ) | |
| (0.01 | ) | |
| (0.00 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average common stock outstanding | |
| | | |
| | | |
| | | |
| | |
Basic and Diluted* | |
| 738,290,665 | | |
| 309,567,766 | | |
| 576,990,761 | | |
| 230,124,665 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
DROR
ORTHO-DESIGN, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(U.S.
dollars, except share amounts)
(Unaudited)
| |
Series
A Preferred Stock | | |
Common
Stock | | |
Treasury
Stock | | |
Additional
Paid-In | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares* | | |
Amount | | |
Shares* | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance
at January 1, 2024 | |
| 10,463,363 | | |
$ | 1,047 | | |
| 495,454,546 | | |
$ | 49,545 | | |
| — | | |
$ | — | | |
$ | 16,842,037 | | |
$ | (13,730,705 | ) | |
$ | 3,161,924 | |
Stock-based
compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 537,197 | | |
| — | | |
| 537,197 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (1,308,463 | ) | |
| (1,308,463 | ) |
Balance
at March 31, 2024 | |
| 10,463,363 | | |
$ | 1,047 | | |
| 495,454,546 | | |
$ | 49,545 | | |
| — | | |
$ | — | | |
$ | 17,379,234 | | |
$ | (15,039,168 | ) | |
$ | 2,390,658 | |
Stock-based
compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 774,428 | | |
| — | | |
| 774,428 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (1,506,790 | ) | |
| (1,506,790 | ) |
Balance
at June 30, 2024 | |
| 10,463,363 | | |
$ | 1,047 | | |
| 495,454,546 | | |
$ | 49,545 | | |
| — | | |
$ | — | | |
$ | 18,153,662 | | |
$ | (16,545,958 | ) | |
$ | 1,658,296 | |
Conversion
of Series A Preferred Stock into Common Stock | |
| (4,615,426 | ) | |
| (462 | ) | |
| 461,542,570 | | |
| 46,154 | | |
| — | | |
| — | | |
| (45,692 | ) | |
| — | | |
| — | |
Stock-based
compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 543,101 | | |
| — | | |
| 543,101 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (1,826,935 | ) | |
| (1,826,935 | ) |
Balance
at September 30, 2024 | |
| 5,847,937 | | |
$ | 585 | | |
| 956,997,116 | | |
$ | 95,699 | | |
| — | | |
$ | — | | |
| 18,651,071 | | |
| (18,372,893 | ) | |
| 374,462 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance
at January 1, 2023 | |
| 7,576,999 | | |
$ | 758 | | |
| 437,735,093 | | |
$ | 43,774 | | |
| — | | |
$ | — | | |
$ | 10,714,366 | | |
$ | (10,162,822 | ) | |
$ | 596,076 | |
Return
of founders shares to the Company as part of claim settlement | |
| — | | |
| — | | |
| (330,952,906 | ) | |
| (33,096 | ) | |
| 330,952,906 | | |
| 33,096 | | |
| — | | |
| — | | |
| — | |
Stock-based
compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 5,032 | | |
| — | | |
| 5,032 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (465,604 | ) | |
| (465,604 | ) |
Balance
at March 31, 2023 | |
| 7,576,999 | | |
$ | 758 | | |
| 106,782,187 | | |
$ | 10,678 | | |
| 330,952,906 | | |
$ | 33,096 | | |
$ | 10,719,398 | | |
$ | (10,628,426 | ) | |
$ | 135,504 | |
Stock-based
compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 5,088 | | |
| — | | |
| 5,088 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (285,782 | ) | |
| (285,782 | ) |
Balance
at June 30, 2023 | |
| 7,576,999 | | |
$ | 758 | | |
| 106,782,187 | | |
$ | 10,678 | | |
| 330,952,906 | | |
$ | 33,096 | | |
$ | 10,724,486 | | |
$ | (10,914,208 | ) | |
$ | (145,190 | ) |
Settlement
of Treasury Stock prior to recapitalization | |
| — | | |
| — | | |
| — | | |
| — | | |
| (330,952,906 | ) | |
| (33,096 | ) | |
| 33,096 | | |
| — | | |
| — | |
Private Placement Investment | |
| 2,886,364 | | |
| 289 | | |
| 186,363,631 | | |
| 18,636 | | |
| — | | |
| — | | |
| 4,634,279 | | |
| — | | |
| 4,653,204 | |
Reverse
re-capitalization | |
| — | | |
| — | | |
| 202,308,728 | | |
| 20,231 | | |
| — | | |
| — | | |
| (793,497 | ) | |
| — | | |
| (773,266 | ) |
Stock-based
compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 2,516 | | |
| — | | |
| 2,516 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (553,536 | ) | |
| (553,536 | ) |
Balance
at September 30, 2023 | |
| 10,463,363 | | |
$ | 1,047 | | |
| 495,454,546 | | |
$ | 49,545 | | |
| — | | |
| — | | |
| 14,600,880 | | |
| (11,467,744 | ) | |
| 3,183,728 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
DROR
ORTHO-DESIGN, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S.
dollars)
| |
For the Nine Months Ended September 30, | |
| |
2024 | | |
2023 | |
| |
(Unaudited) | |
Cash flows from operating activities: | |
| | |
| |
Net loss | |
$ | (4,642,188 | ) | |
$ | (1,304,922 | ) |
Stock-based compensation expense | |
| 1,854,726 | | |
| 12,636 | |
Depreciation | |
| 2,800 | | |
| 502 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Receivables and prepaid expenses | |
| 15,270 | | |
| (40,006 | ) |
Accounts payable | |
| (22,153 | ) | |
| (56,896 | ) |
Accrued expenses and other payables | |
| 92,937 | | |
| (114,529 | ) |
Registration Rights Agreement liability | |
| 520,000 | | |
| — | |
Founders claim accrual | |
| — | | |
| (240,000 | ) |
Accrued Royalties | |
| — | | |
| 6,438 | |
Accrued severance | |
| (117 | ) | |
| (33 | ) |
Net cash used in operating activities | |
| (2,178,725 | ) | |
| (1,736,810 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Purchase of property and equipment | |
| (25,849 | ) | |
| 17,966 | |
Net cash (used in) provided by investing activities | |
| (25,849 | ) | |
| 17,966 | |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from private placement raise | |
| - | | |
| 4,695,336 | |
Net cash provided by financing activities | |
| - | | |
| 4,695,336 | |
| |
| | | |
| | |
Net (decrease) increase in cash | |
| (2,204,574 | ) | |
| 2,976,492 | |
Cash, beginning of period | |
| 3,347,843 | | |
| 1,039,059 | |
Cash, end of period | |
$ | 1,143,269 | | |
$ | 4,015,551 | |
| |
| | | |
| | |
Non-cash activities: | |
| | | |
| | |
Shares issued at reverse recapitalization | |
$ | - | | |
$ | 20,231 | |
Net liabilities assumed in merger | |
$ | - | | |
$ | 791,232 | |
Accrued transaction costs | |
$ | - | | |
$ | 42,132 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
DROR
ORTHO-DESIGN, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note
1 – Organization and Basis of Presentation
Organization
Dror
Ortho-Design, Inc., a Delaware corporation (the “Company”), was incorporated as Novint Technologies, Inc. in the State of
New Mexico in April 1999. On February 26, 2002, the Company changed its state of incorporation to Delaware by merging with Novint Technologies,
Inc., a Delaware corporation. On August 14, 2023, following the Share Exchange (as defined below), the Company changed its name
from “Novint Technologies, Inc.” to “Dror Ortho-Design, Inc.” Following the Share Exchange, the Company succeeded
the business of Dror Ortho-Design, Ltd. (“Private Dror”) as its sole line of business. The Company is involved in the research
and development of an orthodontic alignment platform and has not yet reached the sales stage for its product.
The
Company’s stock is quoted on the OTC Pink Market under the symbol “DROR.”
Reverse
Recapitalization
On July 5, 2023, Private Dror entered into a share exchange agreement
with the Company and on August 14, 2023, the share exchange was consummated (the “Share Exchange”). As a result of the
Share Exchange, the shareholders of Private Dror exchanged all 235,089 of their outstanding shares of ordinary shares of Private Dror,
for 106,782,187 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”), and 7,576,999 shares
of the Company’s Series A Convertible Preferred Stock, par value $0.0001 per share (“Series A Preferred Stock”). Pursuant
to the terms of the Share Exchange, the Company raised $5,225,000 as part of a private placement funding (the “Private Placement”)
pursuant to a Securities Purchase Agreement, by and between the Company and certain purchasers identified therein (the “Private
Placement Investors”), dated as of August 14, 2023 (the “Securities Purchase Agreement”) and the Private Placement Investors
received 186,363,631 shares of Common Stock (the “Private Placement Shares”), 2,886,364 shares of Series A Preferred Stock
and warrants to purchase Common Stock (“Private Placement Warrants”). As a result, Private Dror became a wholly-owned subsidiary
of the Company and the Private Dror shareholders held 56.1% of the Company’s Common Stock equivalents based on the common and preferred
shares received in the Share Exchange.
The
Share Exchange was accounted for as a recapitalization, with Private Dror deemed to be the accounting acquirer and the Company the accounting
acquiree. Accordingly, Private Dror’s historical financial statements for periods prior to the consummation of the Share Exchange
have become those of the registrant. Assets and liabilities and the historical operations reported for periods prior to the Share Exchange
are those of Private Dror other than equity items. All references to Common Stock, Series A Preferred Stock, share and per share amounts
have been retroactively restated to reflect the reverse recapitalization as if the transaction had taken place as of the beginning of
the earliest period presented.
Pursuant
to the Share Exchange, the Company issued shares of its Common Stock and Series A Preferred Stock to Private Dror’s stockholders,
at an exchange ratio of 3,677.27 shares of the Company’s Common Stock.
As
of August 14, 2023, the fair value of the net liabilities of the Company was $793,497, which was recorded as Additional Paid-In Capital
as part of the Share Exchange.
Going
Concern and Management’s Plans
The
financial statements are presented on a going concern basis. The Company has not yet generated any revenues, has suffered recurring losses
from operations with an accumulated deficit of $18,372,893 as of September 30, 2024, and is dependent upon external sources for financing
its operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. Further, the
Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital, its research
and commercialization efforts, regulatory approvals, and, ultimately, the market acceptance of the Company’s products. There is
no assurance that the Company will be successful in raising these funds. These financial statements do not include adjustments that may
result from the outcome of these uncertainties. The Company is exploring additional fundraising opportunities.
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements were prepared using accounting principles generally accepted in the
United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 8
of Regulation S-X. Accordingly, these unaudited condensed consolidated financial statements do not include all information or notes required
by U.S. GAAP for annual consolidated financial statements and should be read in conjunction with the Company’s annual financial
statements for the year ended December 31, 2023, included within the Company’s Current Report on Form 10-K, as amended, originally
filed with the SEC on April 1, 2024.
As
the Company completed a reverse recapitalization on August 14, 2023, the financial information for the periods prior to the reverse recapitalization
reflect those of Private Dror. From August 14, 2023 forward, the financial information presented is the consolidated financial information
of the Company and its subsidiary.
In
the opinion of management, the unaudited consolidated condensed financial statements included herein contain all adjustments necessary
to present fairly the Company’s financial position and the results of its operations and cash flows for the interim periods presented.
Such adjustments are of a normal recurring nature. The results of operations for the nine months ended September 30, 2024, may not be
indicative of results for the full year.
Use
of Estimates and Assumptions
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates or assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements
and the reported amounts of revenue and expenses during the reporting periods. Actual results could vary from those estimates. Management
utilizes various other estimates, including but not limited to Registration Rights Agreement liability, accrued royalties, accrued expenses,
the valuation of stock-based compensation, the valuation allowance for deferred tax assets and other contingencies. The results of any
changes in accounting estimates are reflected in the financial statements in the period in which the changes become evident. Estimates
and assumptions are reviewed periodically and the effects of revisions are reflected in the period that they are determined to be necessary.
Functional
Currency
The
Company accounts for foreign currency transactions pursuant to ASC 830, “Foreign Currency Matters.” The functional currency
of the Company and its subsidiary is the United States Dollar (“U.S. Dollar”) as the U.S. Dollar is the currency of the primary
economic environment in which the Company operates. The accompanying financial statements have been expressed in the U.S. Dollar. Transactions
denominated in currencies other than the functional currency are translated into the functional currency at the exchange rates prevailing
at the dates of the transaction. Monetary assets and liabilities denominated in currencies other than the functional currency are translated
into the functional currency using the applicable exchange rates at the balance sheet dates. The resulting exchange differences are recorded
in the statements of operations. The exchange rate of the U.S. Dollar to the Israeli Shekel was 3.710 and 3.627 as of September 30, 2024
and December 31, 2023, respectively.
Cash
The
Company’s cash is held with financial institutions in the United States and Israel. Management believes that the financial institutions
that hold the Company’s cash are financially sound and, accordingly, minimal credit risk exists with respect to these investments.
Account balances held in the Unites States may, at times, exceed the Federal Deposit Insurance Corporation (“FDIC”) insurance
limit. As of September 30, 2024 and December 31, 2023, the Company had $0 and $145,168, respectively, in excess of the FDIC insurance
limit. As of September 30, 2024 and December 31, 2023, the Company had $1,091,993 and $2,935,078, respectively, in Israeli financial
institutions, which amounts are not uninsured. The Company has not experienced any losses in such accounts with these financial institutions.
Research
and Development
The
Company expenses all research and development costs as they are incurred. Research and development includes, but is not limited to, expenditures
in connection with in-house research and development as well as proprietary products and technology, and includes salaries and related
costs, consulting fees, and professional services.
Basic
and Diluted Net Loss Per Common Share
The
Company computes net loss per share in accordance with ASC 260, “Earnings per Share,” which requires presentation of both
basic and diluted earnings per share (“EPS”) on the face of the income statement. Basic loss per ordinary share is computed
by dividing the loss for the period applicable to common shareholders by the weighted average number of shares of Common Stock outstanding
during the period. Diluted net loss per common share is computed by dividing the net loss by the weighted average number of common stock
outstanding for the period and, if dilutive, potential common stock outstanding during the period. Potentially dilutive securities consist
of the incremental common stock issuable upon exercise of Common Stock equivalents such as stock options, warrants and convertible debt
instruments. Potentially dilutive securities are excluded from the computation if their effect is anti-dilutive. As a result, the basic
and diluted per share amounts for all periods presented are identical.
For
the three and nine months ended September 30, 2024 and 2023, the Company incurred net losses which cannot be diluted; therefore, basic
and diluted loss per common share is the same. Each share of Series A Preferred Stock is convertible into 100 shares of Common Stock
and is included in the table as if converted. As of September 30, 2024 and 2023, shares that are issuable upon conversion of the Series
A Preferred Stock, which could potentially dilute future earnings were as follows:
| |
September 30, | |
| |
2024 | | |
2023 | |
Series A Preferred Stock | |
| 584,793,700 | | |
| 1,046,336,300 | |
Warrants | |
| 975,288,919 | | |
| 964,834,419 | |
Stock Options | |
| 184,264,323 | | |
| 163,142,084 | |
Shares excluded from the calculation of diluted loss per share | |
| 1,744,346,942 | | |
| 2,174,312,803 | |
Reclassification
General
and administrative expenses amounting to $71,071 and $168,113 were reclassified to research and development expenses for the three and
nine months ended September 30, 2023, respectively, to conform with current period presentation. General and administrative expenses
amounting to $2,516 and $12,636 were reclassified to stock-based compensation expenses for the three and nine months ended September
30, 2023, respectively, to conform with current period presentation. The reclassifications had no effect on the net loss for the nine
months ended September 30, 2023.
Recently
Issued Accounting Pronouncements
In
December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures related to improvements
to income tax disclosures. The amendments in this update require enhanced jurisdictional and other disaggregated disclosures for the
effective tax rate reconciliation and income taxes paid. The amendments in this update are effective for fiscal years beginning after
December 15, 2024. The adoption of this pronouncement is not expected to have a material impact on the Company's consolidated financial
statements.
The
Company does not believe that any other recently issued, but not yet effective, accounting standards if currently adopted would have
a material effect on the accompanying consolidated financial statements.
NOTE
3 – REGISTRATIONS RIGHTS AGREEMENT LIABILITY
In
connection with the Private Placement, on August 14, 2023, the Company entered into a registration rights agreement with the Private
Placement Investors (together with all attachments and exhibits thereto, as each may be amended or modified from time to time, the “Registration
Rights Agreement”), pursuant to which the Company agreed to register, among other registrable securities (as further described
in the Registration Rights Agreement), on Form S-1 (or, if the Company is then eligible, on Form S-3) with the Securities and Exchange
Commission (the “SEC”): (i) the Private Placement Shares, (ii) the shares of Common Stock underlying the shares of Series
A Preferred Stock, (iii) the shares of Common Stock underlying the Private Placement Warrants issued to the Private Placement Investors
(the “Warrant Shares”), and (iv) the shares of the Company’s common stock underlying the securities issued to the investors
who, on or about December 6, 2021, participated in the $3,000,000 private placement financing (the “December 2021 Shares”
and, together with the Private Placement Shares, the Conversion Shares, the Warrant Shares, collectively, the “Registrable Securities”).
Under
the Registration Rights Agreement, among other things, if a registration statement registering the resale of the Registrable Securities
is not filed by the 45th calendar date following the date of the Registration Rights Agreement and if such registration statement
is not declared effective by the SEC by the 135th calendar day (or, in the event of a “full review” by the SEC, the 165th
calendar day) following the date of the Registration Rights Agreement, then the Company was required to pay as partial liquidated
damages in amount equal to the product of 1.0% multiplied by the aggregate Subscription Amount (as defined in the Securities Purchase
Agreement) paid by such investor pursuant to the Securities Purchase Agreement every calendar month (pro-rated for periods totaling less
than a calendar month) until filed. Such liquidated damages would bear interest at the rate of 18% per annum (or such lesser maximum
amount that is permitted to be paid by applicable law), accruing daily from the date such partial liquidated damages are due until such
amounts, plus all such interest thereon, are paid in full.
Pursuant
to Section 6(e) of the Registration Rights Agreement, the provisions of the Registration Rights Agreement may be amended by obtaining
the written consent of the Company and the Private Placement Investors holding 50.1% or more of the then-outstanding Registrable Securities
(the “Required Holders”). On February 9, 2024, the Company filed a registration statement on Form S-1 registering for resale
the Registrable Securities, which was declared effective by the SEC on June 14, 2024. On August 13, 2024, the Company and the Required
Holders entered into an Amendment to the Registration Rights Agreement (“Registration Rights Agreement Amendment”), pursuant
to which effective retroactively to September 28, 2023, (i) the date in which a registration statement registering the resale of the
Registrable Securities (the “Registration Statement”) is required to be filed pursuant to the Registration Rights Agreement
was amended to February 9, 2024, and (ii) the date in which the Registration Statement is required to be declared effective by the SEC
pursuant to the Registration Rights Agreement was amended to June 14, 2024. In consideration for entering into the Registration Rights
Agreement Amendment, the Company agreed to pay the Private Placement Investors the liquidated damages equal to the amount that would
otherwise have accrued pursuant to the Registration Rights Agreement, without giving effect to the Registration Rights Agreement Amendment,
which became due and payable upon signing the Registration Rights Agreement Amendment on August 13, 2024, and which did not become due
or payable prior to such date. The Company recorded $520,000 as Liquidated Damages Liability in respect of the Registration Rights Agreement
Amendment. This liability does not bear interest and a repayment date has not yet been determined.
NOTE
4 – COMMITMENTS AND CONTINGENCIES
The
Company partially financed their research and development expenditures under grant programs sponsored by the Israel Innovation Authority
(“IIA”) of the Ministry of Economy and Industry (formerly the Office of Chief Scientist) for the support of research and
development activities conducted in Israel. At the time the grants were received from the IIA, successful development of the related
projects was not assured. In exchange for participation in the programs by the IIA, the Company agreed to pay 3% of total sales of products
developed within the framework of these programs. The royalties will be paid up to a maximum amount equaling 100% of the grants provided
by the IIA, linked to the dollar, bearing annual interest at a rate initially based on LIBOR. Beginning from January 1, 2024, the rate
was adjusted to SOFR (Secured Over Financing Rate). The obligation to pay these royalties is contingent on actual sales of the products,
and in the absence of such sales payment of royalties is not required. In some cases, the Government of Israel’s participation
(through the IIA) is subject to export sales or other conditions. The maximum amount of royalties is increased in the event of production
outside of Israel. The current contingent royalty obligation as of September 30, 2024, and December 31, 2023, is approximately $1.16
million and $1.12 million, respectively.
Legal proceedings
From
time to time in the normal course of business, the Company may be subject to routine litigation incidental to its business. Although
there can be no assurances as to the ultimate disposition of any such matters, it is the opinion of management, based upon the information
available at this time, that there are no matters, individually or in the aggregate, that would have a material adverse effect on the
results of operations and financial condition of the Company.
War
in Israel
In
October 2023, Israel was attacked by a terrorist organization and entered a state of war. As of the date of these consolidated financial
statements, the war in Israel is ongoing and continues to evolve. The Company’s research and development activities are located
in Israel. Currently, such activities in Israel remain largely unaffected. During the nine months ended September 30, 2024, the impact
of this war on the Company’s results of operations and financial condition was immaterial. Management will continue to monitor
the effect of the war on the Company’s financial position and results of operations.
NOTE
5 – FOUNDERS CLAIM ACCRUAL
The
Company recorded a provision in respect of a claim made against Private Dror by its founders. The claim related to amounts claimed as
a repayment of loan balances and other amounts including salary and benefit related balances. In January 2023, Private Dror signed an
agreement with the founders, settling all-outstanding claims at $240,000 which included amounts representing the repayment of a loan,
reimbursement of expenses and an amount for pain and suffering. In addition, the agreement stipulated the transfer back of all shares
held by the founders to the Private Dror for no additional consideration. The settlement was paid in the first quarter of 2023. In addition,
the agreement stipulated the transfer back of all shares (330,952,906 ordinary shares with par value of NIS 0.0001), held by the founders
to the Company.
NOTE
6 – STOCKHOLDERS’ EQUITY
All
references to Common Stock, share and per share amounts have been retroactively restated to reflect the reverse recapitalization as if
the transaction had taken place as of the beginning of the earliest period presented.
Common
Stock
On December 28, 2023, the Company’s stockholders approved the
adoption of the Company’s Amended and Restated Certificate of Incorporation (the “Restated Charter”) and an amendment
to the Restated Charter to increase the number of authorized shares of the Company’s Common Stock from 500,000,000 to 3,254,475,740
(“Authorized Share Increase Amendment”) and to make a corresponding change to the number of authorized shares of capital stock
of the Company. On January 4, 2024, the Company filed the Restated Charter with the Secretary of State of the State of Delaware. All issued
shares of Common Stock are entitled to vote on a 1 share/1 vote basis.
Series
A Preferred Stock
The Company is
authorized to issue up to 12,500,000 shares of $0.0001 par value non-redeemable preferred stock. As of September 30, 2024, 5,847,937
shares of Series A Preferred Stock were outstanding. Each share of Series A Preferred Stock is convertible into Common Stock at any
time at a conversion price of $0.011, or 100 shares of Common Stock for each share of Series A Preferred Stock, subject to
adjustment for certain anti-dilution provisions set forth in the Series A Certificate of Designations. The stockholders of Series A
Preferred Stock are entitled to vote with holders of the Company’s Common Stock, on all matters that such holders of Common
Stock are entitled to vote upon, in the same manner and with the same effect as the holders of Common Stock, voting together with
the holders of Common Stock as a single class. Each share of Preferred Stock shall entitle the stockholder to cast that number of
votes per share of Preferred Stock equal to the number of shares of Common Stock into which such share of Preferred Stock is
convertible (after giving effect to certain limitations on conversion, as applicable). During the three months ended September 30,
2024, holders of the Series A Preferred Stock converted 4,615,426 of Series A Preferred Stock into 461,542,570 shares of Common
Stock.
Warrants
Prior
to the Share Exchange, there were 510,794,865 warrants to purchase Common Stock held by Private Dror shareholders (“Private Dror
Shareholders”). Pursuant to the warrant terms, 20,960,439 warrants expired as a result of the Share Exchange. On August 14,
2023, the Company issued warrants to purchase up to 489,834,426 shares of Common Stock to Private Dror Shareholders in exchange for their
outstanding warrants, and warrants to purchase up to 456,818,176 shares of Common Stock to the private placement investors in respect
of their investment, in addition to warrants to purchase up to 18,181,817 shares of Common Stock issued to private placement investors
in a subsequent closing on September 13, 2023. The warrants expire five years from the initial exercise date and are exercisable
at an exercise price of $0.033 per share. The initial exercise date was dependent on the authorization of additional shares of Common
Stock which occurred on December 28, 2023. The warrants contain provisions that protect their holders against dilution by adjustment
of the purchase price in certain events such as stock dividends, stock splits and other similar events.
On
April 17, 2024, the Board of Directors approved the issuance of 10,454,500 warrants to purchase shares of Common Stock to Oriole Avenue
Inc. (“Oriole”) with the same terms as the warrants issued to the Private Dror Shareholders (see Note 7). The warrants were
issued to an investor in respect of services to be performed pursuant to the Oriole Consulting Agreement (as defined herein) concluding
July 15, 2024. The fair value of the warrants on the date of issuance was $35,814, which was recognized as general and administrative
expense in the Statement of Operations. The aggregate fair value of $35,814 was calculated using the Black-Scholes pricing model with
the following assumptions: (i) expected life of 5 years, (ii) volatility of 77.10%, (iii) risk free rate of 4.62% (iv) dividend rate
of zero, (v) stock price of $0.01, and (vi) exercise price of $0.033.
If
at the time of the warrant’s exercise there is no effective registration statement registering, or no current prospectus available
for, the resale of the shares of Common Stock underlying the warrant, then the holder will have the right to exercise warrant by means
of a cashless exercise. In addition, if (i) the volume-weighted average price of the Company’s Common Stock for 20 consecutive
trading days is at least 300% of the exercise price of the warrants, (ii) the dollar trading volume of the Company’s Common
Stock for each trading day within such 20-day trading period equals or exceeds $500,000, (iii) a registration statement providing
for the resale of the private placement shares is effective and such registration statement has been effective for six (6) months, (iv) the
holder of the warrant is not in possession of any information provided by the Company that constitutes material nonpublic information
and (v) the Company has not breached any of the terms of the investment documents (regardless of if such breach has been cured),
then the warrants may be redeemed at a price of $0.001 per warrant up to one-half, in the aggregate, of the warrants upon not less than
20 days’ prior written notice of redemption to each holder, subject to certain customary restrictions.
Equity
Incentive Plan
Prior
to the Share Exchange, there were 163,142,084 Private Dror employee stock options that had been granted to two executives and a director.
As part of the Share Exchange, the outstanding employee stock options were exchanged and the Company is required to issue new employee
stock options under the Company’s 2023 Long-Term Incentive Plan (the “2023 Plan”) with the same terms as the previously
issued options. As the Company did not yet formalize the actual options exchange agreements, had not yet filed a new Equity Incentive
Plan with the Israeli tax authorities and did not have enough available authorized shares underlying the options to be issued at the
time of the merger, the new employee stock options were not issued. In December 2023 the Company authorized additional shares to cover
the employee stock options and in 2024 prepared all the legal filings for the establishment of the 2023 Plan.
The
Company treated the exchange of the original options for the new options as a modification in accordance with ASC 718. The Company calculated
the fair value of the original options prior to the Share Exchange and the fair value of the new options at the time of the Share Exchange.
The increase in value due to the modification was $4,261,809 and is to be recorded as additional share-based compensation expense. As
one third of the options had fully vested prior to the Share Exchange, the Company recognized one third of the total amount of the increased
value, amounting to $1,420,603 at the time of the Share Exchange. The remaining two thirds of the incremental value relating to the unvested
options are going to be recorded over the remaining vesting period.
On
June 17, 2024, the Company issued 21,122,239 options to purchase Common Stock to Chaim Hurvitz, a director of the Company. The options
have an exercise price of $0.0037 per share, which vested immediately upon grant and terminate 10 years from the grant date. The fair
value of the options on the date of issuance was $170,920, which was recognized as general and administrative expenses in the Statement
of Operations.
Stock-based
compensation expense for the three months ended September 30, 2024 and 2023 amounted to $543,101 and $2,516, respectively. Stock-based
compensation expense for the nine months ended September 30, 2024 and 2023 amounted to $1,854,726 and $12,636, respectively. Share-based
compensation relating to general and administrative expenses amounted to $386,273 and $1,806 for the three months ended September 30,
2024 and 2023, respectively, and $1,379,041 and $9,068 for the nine months ended September 30, 2024 and 2023, respectively. Share-based
compensation relating to research and development expenses amounted to $156,828 and $710 for the three months ended September 30, 2024
and 2023, respectively, and $475,685 and $3,568 for the nine months ended September 30, 2024 and 2023, respectively.
NOTE
7 – RELATED PARTY TRANSACTIONS
Director
Consulting Services
On
June 1, 2022, the Company entered into a consulting agreement (the “Englander Consulting Agreement”) with Yehuda Englander,
a director of the Company, pursuant to which, in consideration for certain financial and strategic consulting services, Mr. Englander
will receive a cash fee of NIS 3,500 each month and was also granted options to purchase 2,610 Ordinary Shares of Private Dror, which
options were exchanged for options to purchase 9,597,675 shares of Common Stock in connection with the Share Exchange and which vest
in three tranches on the first, second, and third anniversary of the date of the Englander Consulting Agreement. The options are subject
to accelerated vesting upon an exit event. On February 7, 2024, the Company amended the Englander Consulting Agreement, which provides
that Mr. Englander’s monthly cash fee in respect of the services provided is equal to $2,500 and in addition to the monthly fee,
Mr. Englander is entitled to expense reimbursement in an amount not to exceed $500. Consulting services paid to the Mr. Englander recorded
as general and administrative expenses for the three months ended September 30, 2024 and 2023 was $8,997 and $2,805, respectively. Consulting
services paid to Mr. Englander recorded as general and administrative expenses for the nine months ended September 30, 2024 and 2023
was $22,153 and $8,647, respectively. Accrued expense balances in respect of the Englander Consulting Agreement at September 30, 2024
and 2023 were $3,100 and $4,576, respectively.
On
February 7, 2024, the Company entered into a consulting agreement (the “Ravad Consulting Agreement”) with Chaim Ravad, a
director of the Company, pursuant to which, in consideration for certain services provided as a board member, Mr. Ravad will receive
a cash fee of $5,000 each month. The Ravad Consulting Agreement is terminable by either party upon 30 days written notice to the other
party and will terminate automatically once Mr. Ravad has received fees in the aggregate amount of $55,000. Consulting services paid
to Mr. Ravad recorded as general and administrative expenses was $15,000 and $0 for the three months ended September 30, 2024 and 2023,
respectively, and $40,000 and $0 for the nine months ended September 30, 2024 and 2023, respectively. Accrued expense balances in respect
of the Ravad Consulting Agreement at September 30, 2024 and 2023 were $5,000 and $0, respectively.
Shareholder
Consulting Services
On August 8, 2023, the
Company entered into a consulting agreement (the “Oriole Consulting Agreement”) with Oriole Avenue Inc.
(“Oriole”), an entity owned by Yaacov Bodner, a stockholder of the Company, pursuant to which, in consideration for
certain shareholder, investors relations and general consultancy services, Oriole is entitled to receive cash payments equal in the
aggregate to $145,000, and warrants to purchase up to an aggregate of 10,454,500 shares of the Company’s Common Stock, with an
exercise price of $0.033 per share and substantially the same terms as the Private Placement Warrants. The cash payment was paid in
equal monthly installments of $14,500, commencing on September 15, 2023, and expiring on July 15, 2024. Although the agreement was
signed and the services were provided, the Board of Directors did not approve of the warrant issuance until April 17, 2024, as
required. The value of those warrants on April 17, 2024 amounted to $35,814 which was amortized over the remaining service period.
Consulting services paid to Oriole recorded as general and administrative expenses for the three months ended September 30, 2024 and
2023 was $0 and $14,500, respectively. Consulting services paid to Oriole recorded as general and administrative expenses for the
nine months ended September 30, 2024 and 2023 was $87,000 and $14,500, respectively.
NOTE
8 – SUBSEQUENT EVENTS
None
Item
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis of the results of operations and financial condition of Dror-Ortho Design, Inc. (the “Company”)
as of September 30, 2024 and for the nine months ended September 30, 2024 and 2023 should be read in conjunction with our financial statements
and the notes to those financial statements that are included elsewhere in this Quarterly Report on Form 10-Q. This discussion and analysis
should be read in conjunction with the Company’s audited financial statements and related disclosures as of December 31, 2023,
which are included in the Form 10-K filed with the Securities and Exchange Commission (“SEC”) on April 1, 2024. References
in this Management’s Discussion and Analysis of Financial Condition and Results of Operations to “us”, “we”,
“our” and similar terms refer to the Company.
Cautionary
Note Regarding Forward-Looking Statements
This
Quarterly Report on Form 10-Q contains “forward-looking statements,” which include information relating to future events,
future financial performance, financial projections, strategies, expectations, competitive environment and regulation. Words such as
“may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,”
“expects,” “anticipates,” “future,” “intends,” “plans,” “believes,”
“estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking
statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance
or results will be achieved. Forward-looking statements are based on information we have when those statements are made or management’s
good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance
or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could
cause such differences include, but are not limited to:
|
● |
our operations and financial
performance depend on global and regional economic conditions. Inflation, fluctuations in currency exchange rates, changes in consumer
confidence and demand, and weakness in general economic conditions and threats, or actual recessions, could materially affect our
business, results of operations, and financial condition.; |
|
● |
the Company is in the development
stage, is not generating revenues and has no operating history in the manufacturing and distribution of orthodontic medical devices
or platforms for consumer use; |
|
● |
our products and technologies
may not be accepted by the intended commercial consumers of our products, which could harm our future financial performance; |
|
● |
we expect continued operating
losses and cannot be certain of our future profitability; |
|
● |
our net revenues will depend
primarily on our Platform and any decline in sales or average selling price of our Platform may adversely affect net revenues, gross
margin and net income; |
|
● |
the Company will face competition
from large internationally established aligner companies whose products have been widely accepted; |
|
● |
our growth and future success
may depend on our ability to enhance our Platform or to develop, obtain regulatory clearance for, successfully introduce, and achieve
market acceptance of new products and services; |
|
● |
we are subject to operating
risks, including excess or constrained capacity and operational inefficiencies, which could adversely affect our results of operations; |
|
● |
our products and information
technology systems are critical to our business. Issues with product development or enhancements, IT system integration, implementation,
updates and upgrades could disrupt our operations and have a material impact on our business and operating results; |
|
● |
complying with regulations
enforced by FDA and other regulatory authorities is expensive and time consuming, and failure to comply could result in substantial
penalties; |
|
● |
we may not receive the
necessary authorizations to market our Platform or any future new products, and any failure to timely do so may adversely affect
our ability to grow our business. |
|
● |
certain modifications to
our products may require new 510(k) clearance or other marketing authorizations; |
|
● |
ongoing changes in healthcare
regulation could negatively affect our revenues, business and financial condition; |
|
● |
we are subject to certain
federal, state, and foreign fraud and abuse laws, health information privacy and security laws, and transparency laws, which, if
violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these
laws could cause adverse publicity and be costly to respond to, and thus could harm our business; |
|
● |
our success depends in
part on our proprietary technology, and if we are unable to successfully enforce our intellectual property rights, our competitive
position may be harmed; |
|
● |
the relative lack of U.S.
public company experience of our management team may put us at a competitive disadvantage; |
|
● |
our Common Stock is not listed on any stock exchange and there is a
limited market for shares of our Common Stock. Even if a market for our Common Stock develops, our Common Stock could be subject to wide
fluctuations; and |
|
● |
other risks and uncertainties
outlined in section entitled “Risk Factors” and other risks detailed from time to time in our filings with the SEC or
otherwise. |
The
foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or
risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements.
For a discussion of these and other risks that relate to our business and financial performance, you should carefully review the risks
and uncertainties described under the heading “Item 1A. Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q
and in our Annual Report on Form 10-K filed on April 1, 2024, and those described from time to time in our future reports filed
with the Securities and Exchange Commission. Moreover, new risks regularly emerge, and it is not possible for us to predict or articulate
all risks we face, nor can we assess the impact of all risks on our business or the extent to which any risk, or combination of risks,
may cause actual results to differ from those contained in any forward-looking statements. All forward-looking statements included in
this Form 10-Q are based on information available to us on the date of this Quarterly Report on Form 10-Q. Except to the extent required
by applicable laws or rules, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result
of new information, future events or otherwise.
Overview
We were incorporated as Novint Technologies, Inc. in the State of New
Mexico in April 1999. On February 26, 2002, we changed our state of incorporation to Delaware by merging with Novint Technologies, Inc.,
a Delaware corporation. On July 5, 2023, we entered into a share exchange agreement with the shareholders of Dror Ortho-Design, Ltd. (“Private
Dror”), pursuant to which, the shareholders of Private Dror agreed to exchange all of their outstanding ordinary shares Private
Dror for shares of our Common Stock, par value $0.0001 per share (“Common Stock”), and Series A Convertible Preferred stock,
par value $0.0001 per share (the “Series A Preferred Stock”, and such transaction, the “Share Exchange”). On August 14,
2023, the Share Exchange was consummated and we changed our name to “Dror Ortho-Design, Inc.”
Following
the Share Exchange, we succeeded to the business of Private Dror as its sole line of business. The Share Exchange is being accounted
for as a recapitalization, with Private Dror deemed to be the accounting acquirer and the Company the acquired company. Accordingly,
Private Dror’s historical financial statements for periods prior to the consummation of the Share Exchange have become those of
the Company. Operations reported for periods prior to the Share Exchange are those of Private Dror.
Our
Company
We
have reimagined the way people can correct their smile.
We
plan to disrupt the aligner market by offering millions of people a revolutionary alternative. We believe that people do not need to
change their lifestyle to correct their smile as they are required to do with existing aligner solutions.
Existing
aligner solutions generally share the same treatment principles, which are different from our solution. In most cases, patients seeking
to improve their smile need to undergo a 12-to-15 month process of wearing plastic aligners, which need to be worn the entire day and
should only be removed while eating or drinking. Patients are prescribed a series of 20 to 30 aligners that are intended to forcefully
move teeth progressively closer to their intended final position. This process causes pain every time a new aligner is used and restricts
blood circulation, which counterproductively slows down tooth movement. All-day aligner solutions are also intrusive, as patients need
to conduct their lives at work or school wearing the plastic aligners. In addition, most existing aligner therapies require multiple
visits to an orthodontist to monitor the progress of treatment plans through intraoral scanning, physical examination and patient testimony.
We
believe that recent rapid advancements in technology have made traditional aligner solutions no longer the most effective treatment option
for smile correction. Our Company has developed a proprietary AI-based platform to correct people’s smiles in a discreet and less
painful manner (the “Platform”). The Platform uses only one smart aligner to gently move teeth into their optimum position
with pulsating air while the patient is sleeping or at home.
We
have several patents for the technology used in the Platform and is currently in the process of preparing the prototype for clearance
by the FDA.
Our
predecessor first generation Aerodentis System is a Class II medical device, which was cleared by FDA for commercialization in the U.S.
pursuant to the 510(k) notification process for movement and alignment of teeth during orthodontic treatment of malocclusion in April
2020. The Company is preparing to apply for 510(k) clearance for the Platform as a Class II medical device, which constitutes an updated
version of the currently cleared device. Such updated Platform contains new and/or different components than the original device, which
is why a new 510(k) clearance is required prior to marketing the Platform in the U.S. We have not yet filed a 510(k) submission for the
Platform, and it has, thus, not been found by the FDA to be substantially equivalent to the first generation Aerodentis System.
The
Company currently does not generate revenues to fund operations and anticipates that it will continue to incur significant losses as
it continues to develop the Platform. Please refer to “Risk Factors - We are in the development stage, are not generating revenues
and have no operating history in the manufacturing and distribution of orthodontic medical devices or platforms for consumer use”
included in our Annual Report on Form 10-K for the year ended December 31, 2023 for additional information. The Company intends to spend
approximately $2 million over the next 12 months on software and hardware development as well as the accompanying regulatory approvals
and IP protection associated with such software and hardware projects.
Recent
Developments
Pursuant
to the terms of the Share Exchange, the Company entered into to a Securities Purchase Agreement, by and between the Company and certain
purchasers identified therein (the “Private Placement Investors”), dated as of August 14, 2023 (the “Securities Purchase
Agreement”), pursuant to which, the Private Placement Investors received shares of Common Stock (the “Private Placement Shares”),
shares of Series A Preferred Stock and warrants to purchase Common Stock (the “Private Placement Warrants”).
In connection with the Private Placement, on August 14, 2023, the Company
entered into a registration rights agreement with the Private Placement Investors (the “Registration Rights Agreement”), pursuant
to which the Company agreed to register, among other registrable securities (as further described in the Registration Rights Agreement),
on Form S-1 (or, if the Company is then eligible, on Form S-3) with the SEC: (i) the Private Placement Shares, (ii) the shares of Common
Stock underlying the shares of Series A Preferred Stock (the “Conversion Shares”), (iii) the shares of Common Stock underlying
the Private Placement Warrants issued to the Private Placement Investors (the “Warrant Shares”), and (iv) the shares of the
Company’s Common Stock underlying the securities issued to the investors who, on or about December 6, 2021, participated in the
$3,000,000 financing (the “December 2021 Shares” and, together with the Private Placement Shares, the Conversion Shares, the
Warrant Shares, the “Registrable Securities” ).
On
August 13, 2024, the Company and certain of the Private Placement Investors entered into an Amendment to the Registration Rights Agreement
(“Registration Rights Agreement Amendment”), pursuant to which, (i) the date in which a registration statement registering
the resale of the Registrable Securities (the “Registration Statement”) is required to be filed pursuant to the Registration
Rights Agreement was amended to February 9, 2024, and (ii) the date in which the Registration Statement is required to be declared effective
by the SEC pursuant to the Registration Rights Agreement was amended to June 14, 2024. In consideration for entering into the Registration
Rights Agreement Amendment, the Company agreed to pay the Private Placement Investors the liquidated damages equal to the amount that
would otherwise have accrued pursuant to the Registration Rights Agreement, without giving effect to the Registration Rights Agreement
Amendment.
Going
Concern
The Company’s unaudited condensed consolidated financial statements
have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal
course of business. During the nine months ended September 30, 2024, the Company’s cash used in operations was $2,161,081 leaving
a cash balance of $1,160,913 as of September 30, 2024. Because the Company does not have sufficient resources to fund its operations for
the next twelve months from the date of this filing, management has substantial doubt about the Company’s ability to continue as
a going concern.
General
The
Company is involved in the research and development of an orthodontic alignment platform. The Company has several patents for the technology
used in the platform and is currently in the process of preparing the prototype for FDA approval.
Results
of Operations
Comparison
of the Three Months Ended September 30, 2024, and the Three Months Ended September 30, 2023
The
following table sets forth the results of operations of the Company for the three months ended September 30, 2024 and September 30, 2023:
| |
Three Months Ended September 30, | | |
| | |
| |
| |
2024 | | |
2023 | | |
Change $ | | |
Change % | |
Research and development | |
$ | 451,030 | | |
$ | 325,360 | | |
$ | 125,670 | | |
| 39 | % |
General and administrative | |
$ | 307,593 | | |
$ | 227,484 | | |
$ | 80,109 | | |
| 35 | % |
Share-based compensation | |
$ | 543,101 | | |
$ | 2,516 | | |
$ | 540,585 | | |
| 21,486 | % |
Other income (expenses), net | |
$ | (525,211 | ) | |
$ | 1,824 | | |
$ | (527,035 | ) | |
| (28,894 | )% |
Research
and development expenses
Research
and development expenses were $451,030 for the three months ended September 30, 2024, compared to $325,360 for the three months ended
September 30, 2023. The increase in research and development expenses of $125,670 or 39%, was primarily due to increased activities relating
to the development of our new product.
General
and administrative expenses
General
and administrative expenses were $307,593 for the three months ended September 30, 2024, compared to $227,484 for the three months ended
September 30, 2023. The increase in general and administrative expenses of $80,109 or 35%, was primarily due to an increase in salaries
and related expenses, as well as professional fees during the three months ended September 30, 2024.
Share-based
Compensation Expenses
Share-based
compensation expenses were $543,101 for the three months ended September 30, 2024, compared to $2,516 for the three months ended September
30, 2023. The increase in share-based compensation expenses of $540,585 or 21,486%, was primarily due to the modification of the outstanding
stock options as part of the Share Exchange.
Other
income (expenses), net
Other
expense was $525,211 for the three months ended September 30, 2024, compared to $1,824 of income for the three months ended September
30, 2023. The decrease in financial income, net of $527,035 or 28,894%, was primarily due to liquidated damages accrual of $520,000 and
exchange rate differences resulting from the translation of NIS based assets and liabilities to U.S. Dollars.
Comparison
of the Nine Months Ended September 30, 2024, and the Nine Months Ended September 30, 2023
The
following table sets forth the results of operations of the Company for the nine months ended September 30, 2024 and September 30, 2023:
| |
Nine Months Ended September 30, | | |
| | |
| |
| |
2024 | | |
2023 | | |
Change $ | | |
Change % | |
Research and development | |
$ | 1,213,903 | | |
$ | 764,721 | | |
$ | 449,182 | | |
| 59 | % |
General and administrative | |
$ | 1,026,431 | | |
$ | 543,929 | | |
$ | 482,502 | | |
| 89 | % |
Share-based compensation | |
$ | 1,854,726 | | |
$ | 12,636 | | |
$ | 1,842,090 | | |
| 14,578 | % |
Other income (expenses), net | |
$ | (547,128 | ) | |
$ | 16,364 | | |
$ | (563,492 | ) | |
| (3,443 | )% |
Research
and development expenses
Research
and development expenses were $1,213,903 for the nine months ended September 30, 2024, compared to $764,721 for the nine months ended
September 30, 2023. The increase in research and development expenses of $449,182 or 59%, was primarily due to increased activities relating
to the development of our new product.
General
and administrative expenses
General
and administrative expenses were $1,026,431 for the nine months ended September 30, 2024, compared to $543,929 for the nine months ended
September 30, 2023. The increase in general and administrative expenses of $482,502 or 89%, was primarily due to an increase in salaries
and related expenses, as well as professional fees during the nine months ended September 30, 2024.
Share-based
Compensation Expenses
Share-based
compensation expenses were $1,854,726 for the nine months ended September 30, 2024, compared to $12,636 for the nine months ended September
30, 2023. The increase in share-based compensation expenses of $1,842,090 or 14,578%, was primarily due to the modification of the outstanding
stock options as part of the Share Exchange.
Other
income (expenses), net
Other
expense was $547,128 for the nine months ended September 30, 2024, compared to $16,364 of income for the nine months ended September
30, 2023. The decrease in other income, net of $563,492 or 3,443%, was primarily due to liquidated damages accrual of $520,000 and exchange
rate differences resulting from the translation of NIS based assets and liabilities to U.S. Dollars.
Liquidity
and Capital Resources
Sources
of Liquidity
We
do not have revenues to fund operations. We anticipate that we will continue to incur significant losses as we continue to develop our
product. Historically, our primary source of cash has been proceeds from the sale of equity instruments. We raised $5.225 million through
a private placement sale of shares to new investors concurrent with the Share Exchange. We intend to spend approximately $2 million over
the next 12 months on software and hardware development as well as the accompanying regulatory approvals and IP protection associated
with such software and hardware projects.
We
will need to raise additional capital to fund operating losses and grow our operations. There can be no assurance however that we will
be able to raise additional capital when needed, or at terms deemed acceptable, if at all. Such factors raise substantial doubt about
our ability to sustain operations for at least one year from the issuance of the interim condensed consolidated financial statements
included in this Quarterly Report on Form 10-Q. The accompanying financial statements do not include any adjustments related to the recoverability
and classification of asset amounts or the classification of liabilities that might be necessary should we be unable to continue as a
going concern. For additional information, see the section above titled “MD&A—Going Concern.”
Cash
Flows
| |
Nine months ended September 30, | |
| |
2024 | | |
2023 | |
Cash used in | |
| | |
| |
Operating activities | |
$ | (2,178,725 | ) | |
$ | (1,736,810 | ) |
Investing activities | |
| (25,849 | ) | |
| 17,966 | |
Financing activities | |
| - | | |
| 4,695,336 | |
Net decrease in cash and cash equivalents | |
$ | (2,204,574 | ) | |
$ | 2,976,492 | |
Operating
activities
Net
cash used in operating activities was $2,178,725 for the nine months ended September 30, 2024 as compared to $1,736,810 for the nine
months ended September 30, 2023. The amount for the nine months ended September 30, 2024 primarily consisted of a net loss of $4,642,188
offset by non-cash charges of $1,857,526 (including: depreciation of $2,800 and share-based compensation expense of $1,854,726), and
an increase in working capital excluding cash of $605,937. The amount for the nine months ended September 30, 2023 primarily consisted
of a net loss of $1,304,922 offset by non-cash charges of $13,138 (including: Share-based compensation expense of $12,636 and depreciation
of $502), and a decrease in working capital excluding cash of $445,026.
Investing
Activities
During
the nine months ended September 30, 2024, net cash used in investing activities was $25,849 relating to the purchase of fixed assets.
During the nine months ended September 30, 2023, net cash provided by investing activities was $17,966 relating to the cash received
in the Share Exchange.
Financing
activities
During
the nine months ended September 30, 2024. There was no cash provided by or used in financing activities. During the nine months ended
September 30, 2023, net cash provided by financing activities was $4,695,336 relating to the net proceeds from the private placement
raise.
Effects
of Inflation
Management
does not believe that inflation has had a material impact on the Company’s business, sales, or operating results during the periods
presented.
Off-Balance
Sheet Arrangements
The
Company currently does not have any off-balance sheet arrangements or financing activities with special-purpose entities.
Critical
Accounting Policies and Use of Estimates
The
SEC defined a company’s critical accounting policies as the ones that are most important to the portrayal of our financial condition
and results of operations and which require us to make our most difficult and subjective judgments, often as a result of the need to
make estimates of matters that are inherently uncertain.
Based
on this definition, we have identified the critical accounting policies and judgments addressed below. We also have other key accounting
policies that are significant to understanding our results.
Research
and Development
We
expense all research and development costs as they are incurred. Research and development includes expenditures in connection with in-house
research and development salaries and staff costs, consulting fees, as well as proprietary products and technology.
Use
of Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates or assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements
and the reported amounts of revenue and expenses during the reporting periods. Actual results could vary from those estimates. Management
utilizes various other estimates, including but not limited to accrued royalties, estimated lives of long-lived assets, the valuation
of stock-based compensation, the valuation allowance for deferred tax assets and other contingencies. The results of any changes in accounting
estimates are reflected in the financial statements in the period in which the changes become evident. Estimates and assumptions are
reviewed periodically, and the effects of revisions are reflected in the period that they are determined to be necessary.
Recent
Accounting Pronouncements
The
Company has reviewed the recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American
Institute of Certified Public Accountants, and the SEC and determined that these pronouncements do not have a material impact on the
Company’s current or anticipated consolidated financial statement presentation or disclosures.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required
under this item.
Item
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Our
principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures
(as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”), Rule 13a-15(e) and 15d-15(e)) as of
the end of the period covered by this Quarterly Report on Form 10-Q, have concluded that, based on such evaluation, our disclosure controls
and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the
Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and
is accumulated and communicated to our management, including our principal executive officer and principal financial officer as appropriate,
to allow timely decisions regarding required disclosure.
Change
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during our last fiscal quarter ended September 30, 2024
that have materially affected, or are reasonably likely to affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
From
time to time, we may be involved in litigation that arises through the normal course of business. As of the date of this filing, we are
not a party to any material litigation nor are we aware of any such threatened or pending litigation.
There
are no proceedings in which any of our directors, officers, affiliates or any registered or beneficial stockholders is an adverse party
or has a material interest adverse to our interest.
Item
1A. Risk Factors
The
following description of risk factors includes any material changes to, and supersedes the description of, the risk factors addressed
below associated with our business, financial condition and results of operations previously disclosed in “Item 1A. Risk Factors”
of our Annual Report for the year ended December 31, 2023 on Form 10-K, as filed with the SEC on April 1, 2024 as amended
on April 25, 2024. Our business, financial condition and operating results can be affected by a number of factors, whether currently
known or unknown, including but not limited to those described below, any one or more of which could, directly or indirectly, cause our
actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating
results. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating
results and stock price.
The
following discussion of risk factors contains forward-looking statements. This risk factor may be important to understanding other statements
in this Form 10-Q. The following information should be read in conjunction with the condensed consolidated financial statements and related
notes in Part I, Item 1, “Financial Statements” and Part I, Item 2, “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” of this Form 10-Q.
The
Company’s financial statements have been prepared on a going concern basis and do not include adjustments that might be necessary
if the Company is unable to continue as a going concern. Management has substantial doubt about the Company’s ability to continue
as a going concern.
The
Company’s unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates
the realization of assets and the satisfaction of liabilities in the normal course of business. During the nine months ended September
30, 2024, the Company’s cash used in operations was $2,178,725 leaving a cash balance of $1,143,269 as of September 30, 2024. Because
the Company does not have sufficient resources to fund our operations for the next twelve months from the date of this filing, management
has substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not
include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that
might be necessary should the Company be unable to continue as a going concern.
The
Company will need to raise additional capital to finance its losses and negative cash flows from operations and may continue to be dependent
on additional capital raising as long as its products do not reach commercial profitability. There are no assurances that the Company
would be able to raise additional capital on terms favorable to it. If the Company is unsuccessful in commercializing its products and
raising capital, it will need to reduce activities, curtail, or cease operations.
We
conduct our operations in Israel. Conditions in Israel, including the recent attack by Hamas and other terrorist organizations from the
Gaza Strip and Israel’s war against them, may affect our operations.
Because
our wholly-owned subsidiary is incorporated under the laws of the State of Israel, all of our operations are conducted in Israel and
all of our employees and management personnel are located in Israel, our business and operations are directly affected by economic, political,
geopolitical and military conditions in Israel. Since the establishment of the State of Israel in 1948, a number of armed conflicts have
occurred between Israel and its neighboring countries and terrorist organizations active in the region. These conflicts have involved
missile strikes, hostile infiltrations and terrorism against civilian targets in various parts of Israel, which have negatively affected
business conditions in Israel.
In
October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian
and military targets. Hamas also launched extensive rocket attacks on the Israeli population, industrial centers located along Israel’s
border with the Gaza Strip and in other areas within the State of Israel. Following the attack, Israel’s security cabinet declared
war against Hamas and a military campaign against these terrorist organizations commenced in parallel to their continued rocket and terror
attacks. Moreover, the clash between Israel and Hezbollah in Lebanon may escalate in the future into a greater regional conflict.
Any
hostilities involving Israel, or the interruption or curtailment of trade within Israel or between Israel and its trading partners, could
adversely affect our operations and results of operations and could make it more difficult for us to raise capital. Parties with whom
we may do business have sometimes declined to travel to Israel during periods of heightened unrest or tension, forcing us to make alternative
arrangements when necessary. The conflict situation in Israel could cause situations where medical product certifying or auditing bodies
could not be able to visit manufacturing facilities of our subcontractors in Israel in order to review our certifications or clearances,
thus possibly leading to temporary suspensions or even cancellations of our product clearances or certifications. The conflict situation
in Israel could also result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated
to perform their commitments under those agreements pursuant to force majeure provisions in such agreements.
There
have been travel advisories imposed as related to travel to Israel, and restrictions on travel or delays and disruptions as related to
imports and exports may be imposed in the future. An inability to receive supplies and materials, shortages of materials or difficulties
in procuring our materials, among others, may adversely impact our ability to commercialize and manufacture our product candidates and
products in a timely manner. This could cause a number of delays and/or issues for our operations, including delay of the review of our
product candidates by regulatory agencies, which in turn would have a material adverse impact on our ability to commercialize our product
candidates.
The
Israel Defense Force (the “IDF”), the national military of Israel, is a conscripted military service, subject to certain
exceptions. Several employees of our vendors are subject to military service in the IDF and have been or may be called to serve. It is
possible that there will be further military reserve duty call-ups in the future, which may affect our business due to a shortage of
skilled labor and loss of institutional knowledge, and necessary mitigation measures we may take to respond to a decrease in labor availability,
such as overtime and third-party outsourcing, which may have unintended negative effects and adversely impact our results of operations,
liquidity or cash flows.
It
is currently not possible to predict the duration or severity of the ongoing conflict or its effects on our business, operations and
financial conditions. The ongoing conflict is rapidly evolving and developing, and could disrupt our business and operations, interrupt
our sources and availability of supplies, and hamper our ability to raise additional funds or sell our securities, among others.
Item
2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities.
There
were no unregistered sales of the Company’s equity securities during the three months ended September 30, 2024, other than those
previously reported in a Current Report on Form 8-K.
Item
3. Defaults Upon Senior Securities
Not
applicable.
Item
4. Mine Safety Disclosures
Not
Applicable.
Item
5. Other Information
Not
Applicable.
Item
6. Exhibits
* |
Filed herewith. |
** |
Furnished herewith. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
DROR-ORTHO DESIGN, INC. |
|
|
|
Date: November 14, 2024 |
By: |
/s/ Eliyahu
(Lee) Haddad |
|
Name: |
Eliyahu (Lee) Haddad |
|
Title: |
(Principal
Executive Officer and
Principal
Financial and Accounting Officer) |
|
|
|
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This certification is furnished solely pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350) and accompanies the Quarterly Report on Form 10-Q (the “Form 10-Q”)
for the quarter ended September 30, 2024, of Dror-Ortho Design, Inc. (the “Company”). I, Eliyahu (Lee) Haddad, the Chief Executive
Officer of the Company, certify that, based on my knowledge:
This certification is furnished solely pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350) and accompanies the Quarterly Report on Form 10-Q (the “Form 10-Q”)
for the quarter ended September 30, 2024, of Dror-Ortho Design, Inc. (the “Company”). I, Eliyahu (Lee) Haddad, the Chief Financial
Officer of the Company, certify that, based on my knowledge: