UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(MARK ONE)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, 2020
For the quarter ended December 31, 2018☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number:001-38762
BiomX Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware | 82-3364020 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
17 State St, FL21
New York, NY 10004
(Address of principal executive offices)
7 Pinhas Sapir St., Floor 2, Ness Ziona, Israel | 7414002 | |
(Address of principal executive offices) | (Zip Code) |
(646) 229-7549
(Issuer’sRegistrant’s telephone number)number, including area code: +972 723942377
CheckFormer name, former address and former fiscal year, if changed since last report: n/a
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Units, each consisting of one share of common stock, $0.0001 par value, and one Warrant entitling the holder to receive one half share of common stock | PHGE.U | NYSE American | ||
Common stock, $0.0001 par value, included as part of the units | PHGE | NYSE American | ||
Warrants included as part of the units | PHGE.WS | NYSE American |
Indicate by check mark whether the issuerregistrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the pastpreceding 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 every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit 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”,filer,” “accelerated filer”,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 ☒ No☐
As of February 5, 2019, 9,012,500November 9, 2020, 23,177,922 shares common stock, par value $0.0001 per share, were issued and outstanding.
BIOMX INC.
CHARDAN HEALTHCARE ACQUISITION CORP.
FORM 10-Q FOR THE QUARTER ENDED DECEMBER 31, 2018 SEPTEMBER 30, 2020
TABLE OF CONTENTS
i
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION
This quarterly report on Form 10-Q (the “Quarterly Report”) includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and other securities laws. For example, we are making forward-looking statements when we discuss our clinical and pre-clinical development program, including timing and milestones thereof as well as the design thereof, including acceptance of regulatory agencies of such design, the potential opportunities for and benefits of the BOLT platform, as described below, the potential of our product candidates, the potential effect of the coronavirus disease 2019 (“COVID-19”) on our business and levels of expenses, sufficiency of financial resources and financial needs. These statements include words such as “expect,” “believe,” “anticipate,” “intend,” “estimate,” “seek” and variations and similar words and expressions are intended to identify such forward-looking statements. However, you should understand that these statements are not guarantees of performance or results, and there are a number of risks, uncertainties and other important factors that could cause our actual results to differ materially from those expressed in the forward-looking statements, including, among others:
● | our limited operating history; | |
● | the ability to generate revenues, and raise sufficient financing to meet working capital requirements; | |
● | the unpredictable timing and cost associated with our approach to developing product candidates using phage technology; | |
● | the impact of the COVID-19 pandemic on general economic conditions, our operations, the continuity of our business, including our preclinical and clinical trials and our ability to raise additional capital; | |
● | the U.S. Food and Drug Administration’s (“FDA”) classification of our BX001 product candidate for acne-prone skin as a drug or cosmetic and the impact of changing regulatory requirements on our ability to develop and commercialize BX001; | |
● | obtaining FDA acceptance of any non-U.S. clinical trials of product candidates; | |
● | the ability to pursue and effectively develop new product opportunities and acquisitions and to obtain value from such product opportunities and acquisitions; | |
● | penalties and market withdrawal associated with any unanticipated problems with product candidates and failure to comply with labeling and other restrictions; | |
● | expenses associated with compliance with ongoing regulatory obligations and successful continuing regulatory review; | |
● | market acceptance of our product candidates and ability to identify or discover additional product candidates; | |
● | our ability to obtain high titers for specific phage cocktails necessary for preclinical and clinical testing; | |
● | the availability of specialty raw materials; | |
● | the ability of our product candidates to demonstrate requisite safety and tolerability for cosmetics, safety and efficacy for drug products, or safety, purity and potency for biologics without causing adverse effects; | |
● | the success of expected future advanced clinical trials of our product candidates; | |
● | our ability to obtain required regulatory approvals; | |
● | our ability to enroll patients in clinical trials and achieve anticipated development milestones when expected; | |
● | delays in developing manufacturing processes for our product candidates; |
ii
● | competition from similar technologies, products that are more effective, safer or more affordable than our product candidates or products that obtain marketing approval before our product candidates; | |
● | the impact of unfavorable pricing regulations, third-party reimbursement practices or health care reform initiatives on our ability to sell product candidates or therapies profitably; | |
● | protection of our intellectual property rights and compliance with the terms and conditions of current and future licenses with third parties; | |
● | infringement on the intellectual property rights of third parties and claims for remuneration or royalties for assigned service invention rights; | |
● | our ability to acquire, in-license or use proprietary rights held by third parties necessary to our product candidates or future development candidates; | |
● | ethical, legal and social concerns about synthetic biology and genetic engineering that may adversely affect market acceptance of our product candidates; | |
● | reliance on third-party collaborators; | |
● | our ability to manage the growth of the business; | |
● | our ability to attract and retain key employees or to enforce the terms of noncompetition agreements with employees; | |
● | the failure to comply with applicable laws and regulations; | |
● | potential security breaches, including cybersecurity incidents; | |
● | political, economic and military instability in the State of Israel; and | |
● | other factors discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (the “2019 Annual Report”). |
For a detailed discussion of these and other risks, uncertainties and factors, see Part I, Item 1A— “Risk Factors” of our 2019 Annual Report and in Part II, Item 1A of this Quarterly Report. All forward-looking statements contained in this Quarterly Report speak only as of the date hereof. Except as required by law, we are under no duty to (and expressly disclaim any such obligation to) update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this Quarterly Report. Comparisons of results between current and prior periods are not intended to express any future trends, or indications of future performance, and should be viewed only as historical data.
iii
PART I - FINANCIAL INFORMATION
CHARDAN HEALTHCARE ACQUISITION CORP.
CONDENSED BALANCE SHEETS Item 1. Financial Statements
December 31, 2018 | June 30, 2018 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current Assets | ||||||||
Cash | $ | 846,840 | $ | 430 | ||||
Prepaid expenses and other current assets | 70,300 | — | ||||||
Total Current Assets | 917,140 | 430 | ||||||
Deferred offering costs | — | 64,545 | ||||||
Marketable securities held in Trust Account | 70,034,459 | — | ||||||
Total Assets | $ | 70,951,599 | $ | 64,975 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities | ||||||||
Accounts payable and accrued expenses | $ | 11,800 | $ | 1,000 | ||||
Accrued offering costs | 21,370 | — | ||||||
Income taxes payable | 8,212 | — | ||||||
Promissory note - related party | — | 40,000 | ||||||
Total Current Liabilities | 41,382 | 41,000 | ||||||
Promissory note – related party | 500,000 | — | ||||||
Total Liabilities | 541,382 | 41,000 | ||||||
Commitments | ||||||||
Common stock subject to possible redemption, 6,539,086 and no shares at redemption value as of December 31, 2018 and June 30, 2018, respectively | 65,410,211 | — | ||||||
Stockholders’ Equity | ||||||||
Preferred stock, $0.0001 par value; 1,000,000 shares authorized; none issued and outstanding | — | — | ||||||
Common stock, $0.0001 par value; 30,000,000 shares authorized; 2,473,414 and 2,012,500 shares issued and outstanding (excluding 6,539,086 and no shares subject to possible redemption) as of December 31, 2018 and June 30, 2018, respectively(1) | 247 | 201 | ||||||
Additional paid-in capital | 4,990,976 | 24,799 | ||||||
Retained earnings/(Accumulated deficit) | 8,783 | (1,025 | ) | |||||
Total Stockholders’ Equity | 5,000,006 | 23,975 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 70,951,599 | $ | 64,975 |
INDEX TO FINANCIAL STATEMENTS
(formerly known as Chardan Healthcare Acquisition Corp.)
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)
USD in thousands, except share and per share data
As of | ||||||||||
Note | September 30, | December 31, 2019 | ||||||||
ASSETS | ||||||||||
Current assets | ||||||||||
Cash and cash equivalents | 53,302 | 72,256 | ||||||||
Restricted cash | 855 | 154 | ||||||||
Short-term deposits | 3 | 10,390 | 10,003 | |||||||
Related party | 9 | - | 50 | |||||||
Other current assets | 755 | 2,068 | ||||||||
Total current assets | 65,302 | 84,531 | ||||||||
Non-current assets | ||||||||||
Lease deposit | - | 5 | ||||||||
Property and equipment, net | 2,062 | 1,881 | ||||||||
In-process research and development (“R&D”), net | 6 | 3,419 | 4,556 | |||||||
Operating lease right-of-use assets | 4 | 4,370 | 1,148 | |||||||
Total non-current assets | 9,851 | 7,590 | ||||||||
75,153 | 92,121 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
CHARDAN HEALTHCARE ACQUISITION CORP.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended December 31, | Six Months Ended December 31, | |||||||
2018 | 2018 | |||||||
Operating costs | $ | 15,789 | $ | 16,439 | ||||
Loss from operations | (15,789 | ) | (16,439 | ) | ||||
Other income: | ||||||||
Interest income | 55,546 | 55,546 | ||||||
Unrealized loss on marketable securities held in Trust Account | (21,087 | ) | (21,087 | ) | ||||
Other income, net | 34,459 | 34,459 | ||||||
Income before provision for income taxes | 18,670 | 18,020 | ||||||
Provision for income taxes | (8,212 | ) | (8,212 | ) | ||||
Net income | $ | 10,458 | $ | 9,808 | ||||
Weighted average shares outstanding, basic and diluted(1) | 1,815,004 | 1,782,502 | ||||||
Basic and diluted net loss per common share(2) | $ | (0.00 | ) | $ | (0.01 | ) |
2
(formerly known as Chardan Healthcare Acquisition Corp.)
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)
USD in thousands, except share and per share data
As of | ||||||||||||
Note | September 30, 2020 | December 31, 2019 | ||||||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||||
Current liabilities | ||||||||||||
Trade account payables | 1,301 | 3,253 | ||||||||||
Other account payables | 2,814 | 2,596 | ||||||||||
Current portion of lease liabilities | 4 | 594 | 375 | |||||||||
Total current liabilities | 4,709 | 6,224 | ||||||||||
Non-current liabilities | ||||||||||||
Lease liabilities, net of current portion | 4 | 3,905 | 856 | |||||||||
Contingent liabilities | 5,7 | 701 | 585 | |||||||||
Total non-current liabilities | 4,606 | 1,441 | ||||||||||
Commitments and Contingent Liabilities | 7 | |||||||||||
Shareholders’ equity | ||||||||||||
Common stock, $0.0001 par value (“Common Stock”); Authorized - 60,000,000 shares as of September 30, 2020 and December 31, 2019. Issued - 23,173,378 as of September 30, 2020 and 22,862,835 as of December 31, 2019. Outstanding - 23,167,678 shares as of September 30, 2020 and 22,862,835 as of December 31, 2019 | 8 | 2 | 2 | |||||||||
Additional paid in capital | 128,950 | 126,626 | ||||||||||
Accumulated deficit | (63,114 | ) | (42,172 | ) | ||||||||
Total shareholders’ equity | 65,838 | 84,456 | ||||||||||
75,153 | 92,121 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
CHARDAN HEALTHCARE ACQUISITION CORP.
CONDENSED STATEMENT OF CASH FLOWS
SIX MONTHS ENDED DECEMBER 31, 2018
(Unaudited)
Cash Flows from Operating Activities: | ||||
Net income | $ | 9,808 | ||
Adjustments to reconcile net income to net cash used in operating activities: | ||||
Interest earned on marketable securities held in Trust Account | (55,546 | ) | ||
Unrealized loss on marketable securities held in Trust Account | 21,087 | |||
Changes in operating assets and liabilities: | ||||
Prepaid expenses and other current assets | (70,300 | ) | ||
Accounts payable and accrued expenses | 10,800 | |||
Income taxes payable | 8,212 | |||
Net cash used in operating activities | (75,939 | ) | ||
Cash Flows from Investing Activities: | ||||
Investment of cash in Trust Account | (70,000,000 | ) | ||
Net cash used in investing activities | (70,000,000 | ) | ||
Cash Flows from Financing Activities: | ||||
Proceeds from sale of Units, net of underwriting discounts paid | 69,500,000 | |||
Proceeds from sale of Private Placement Warrants | 1,160,000 | |||
Proceeds from promissory notes – related party | 565,500 | |||
Repayment of promissory notes – related party | (105,500 | ) | ||
Payment of offering costs | (197,651 | ) | ||
Net cash provided by financing activities | 70,922,349 | |||
Net Change in Cash | 846,410 | |||
Cash – Beginning | 430 | |||
Cash – Ending | $ | 846,840 | ||
Non-cash investing and financing activities: | ||||
Initial classification of common stock subject to redemption | $ | 65,399,750 | ||
Change in value of common stock subject to redemption | $ | 10,461 | ||
Offering costs included in accrued offering costs | $ | 21,370 |
3
(formerly known as Chardan Healthcare Acquisition Corp.)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
USD in thousands, except share and per share data
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||
Note | 2020 | 2019 | 2020 | 2019 | ||||||||||||||
Research and development expenses, net | 6,436 | 2,858 | 14,441 | 8,458 | ||||||||||||||
General and administrative expenses | 2,394 | 1,797 | 6,749 | 3,987 | ||||||||||||||
Operating loss | 8,830 | 4,655 | 21,190 | 12,445 | ||||||||||||||
Financial expenses (income), net | 5 | (395 | ) | (248 | ) | (1,182 | ) | |||||||||||
Net Loss | 8,835 | 4,260 | 20,942 | 11,263 | ||||||||||||||
Basic and diluted loss per share of Common Stock | 10 | 0.38 | 2.69 | 0.91 | 7.37 | |||||||||||||
Weighted average number of shares of Common Stock outstanding, basic and diluted | 23,150,253 | 2,035,625 | 23,013,790 | 2,015,349 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
(formerly known as Chardan Healthcare Acquisition Corp.)
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (unaudited)
USD in thousands, except share and per share data
Common Stock | Additional paid | Accumulated | Total shareholders’ | |||||||||||||||||
Shares | Amount | in capital | deficit | equity | ||||||||||||||||
Balance as of December 31, 2019 | 22,862,835 | 2 | 126,626 | (42,172 | ) | 84,456 | ||||||||||||||
Exercise of options | 57,325 | (* | ) | 106 | - | 106 | ||||||||||||||
Share-based payment | - | - | 337 | - | 337 | |||||||||||||||
Net loss | - | - | - | (5,901 | ) | (5,901 | ) | |||||||||||||
Balance as of March 31, 2020 | 22,920,160 | 2 | 127,069 | (48,073 | ) | 78,998 | ||||||||||||||
Exercise of options | 220,104 | (* | ) | 52 | - | 52 | ||||||||||||||
Share-based payment | - | - | 677 | - | 677 | |||||||||||||||
Net loss | - | - | - | (6,206 | ) | (6,206 | ) | |||||||||||||
Balance as of June 30, 2020 | 23,140,264 | 2 | 127,798 | (54,279 | ) | 73,521 | ||||||||||||||
Exercise of options | 27,414 | - | 38 | - | 38 | |||||||||||||||
Share-based payment | - | - | 1,114 | - | 1,114 | |||||||||||||||
Net loss | - | - | - | (8,835 | ) | (8,835 | ) | |||||||||||||
Balance as of September 30, 2020 | 23,167,678 | 2 | 128,950 | (63,114 | ) | 65,838 |
(*) | Less than $1. |
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (unaudited)
USD in thousands, except share and per share data
Common Stock | Preferred A Shares (pre-merger- | Preferred B Shares (pre-merger- | Additional paid in | Accumulated | Total shareholders’ | |||||||||||||||||||||||||||||||
Shares (**) | Amount | Shares (**) | Amount | Shares (**) | Amount | capital | deficit | equity | ||||||||||||||||||||||||||||
Balance as of December 31, 2018 | 2,307,871 | (* | ) | 7,543,831 | 1 | 5,170,357 | 1 | 64,410 | (21,609 | ) | 42,803 | |||||||||||||||||||||||||
Issuance of shares | - | - | - | - | 308,628 | (* | ) | 1,800 | - | 1,800 | ||||||||||||||||||||||||||
Share-based payment | - | - | - | - | - | - | 304 | - | 304 | |||||||||||||||||||||||||||
Net loss | - | - | - | - | - | - | - | (3,225 | ) | (3,225 | ) | |||||||||||||||||||||||||
Balance as of March 31, 2019 | 2,307,871 | (* | ) | 7,543,831 | 1 | 5,478,985 | 1 | 66,514 | (24,834 | ) | 41,682 | |||||||||||||||||||||||||
Share-based payment | - | - | - | - | - | - | 327 | - | 327 | |||||||||||||||||||||||||||
Net loss | - | - | - | - | - | - | - | (3,778 | ) | (3,778 | ) | |||||||||||||||||||||||||
Balance as of June 30, 2019 | 2,307,871 | (* | ) | 7,543,831 | 1 | 5,478,985 | 1 | 66,841 | (28,612 | ) | 38,231 | |||||||||||||||||||||||||
Share-based payment | - | - | - | - | - | - | 249 | - | 249 | |||||||||||||||||||||||||||
Exercise of options | 41,200 | (* | ) | - | - | - | - | 43 | - | 43 | ||||||||||||||||||||||||||
Net loss | - | - | - | - | - | - | - | (4,260 | ) | (4,260 | ) | |||||||||||||||||||||||||
Balance as of September 30, 2019 | 2,349,071 | (* | ) | 7,543,831 | 1 | 5,478,985 | 1 | 67,133 | (32,872 | ) | 34,263 |
(*) | Less than $1. |
(**) | Number of shares has been retroactively adjusted based on the equivalent number of shares received by the accounting acquirer in the Recapitalization Transaction consummated on October 28, 2019 (refer to Note 1). |
The accompanying notes are an integral part of these condensed consolidated financial statements.
CHARDAN HEALTHCARE ACQUISITION CORP.
NOTES TO CONDENSED FINANCIAL STATEMENTSBIOMX INC.
DECEMBER 31, 2018
(Unaudited)
NOTE 1. DESCRIPTION OF ORGANIZATION AND BUSINESS OPERATIONS
(formerly known as Chardan Healthcare Acquisition Corp. (the)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)
USD in thousands
For the nine months ended September 30, | ||||||||
2020 | 2019 | |||||||
CASH FLOWS – OPERATING ACTIVITIES | ||||||||
Net loss | (20,942 | ) | (11,263 | ) | ||||
Adjustments required to reconcile cash flows used in operating activities | ||||||||
Depreciation and amortization | 1,618 | 259 | ||||||
Share-based compensation | 2,128 | 880 | ||||||
Revaluation of contingent liabilities | 116 | 20 | ||||||
Changes in operating assets and liabilities: | ||||||||
Other receivables | 1,318 | 21 | ||||||
Trade account payables | (1,877 | ) | (119 | ) | ||||
Other account payables | 218 | (151 | ) | |||||
Operating lease liabilities | 46 | - | ||||||
Related party | 50 | (150 | ) | |||||
Net cash used in operating activities | (17,325 | ) | (10,503 | ) | ||||
CASH FLOWS – INVESTING ACTIVITIES | ||||||||
Decrease (Increase) in short-term deposits | (387 | ) | 12,618 | |||||
Purchase of property and equipment | (662 | ) | (987 | ) | ||||
Net cash provided by (used in) investing activities | (1,049 | ) | 11,631 | |||||
CASH FLOWS – FINANCING ACTIVITIES | ||||||||
Issuance of preferred shares, net | - | 1,800 | ||||||
Outflows in connection with current assets and liabilities acquired in Recapitalization Transaction | (75 | ) | - | |||||
Exercise of stock options | 196 | 43 | ||||||
Net cash provided by financing activities | 121 | 1,843 | ||||||
Increase (decrease) in cash and cash equivalents and restricted cash | (18,253 | ) | 2,971 | |||||
Cash and cash equivalents and restricted cash at the beginning of the period | 72,410 | 8,693 | ||||||
Cash and cash equivalents and restricted cash at the end of the period | 54,157 | 11,664 | ||||||
Supplemental non-cash transactions: | ||||||||
Recognition of right-of-use asset and lease liability upon adoption of ASU 2016-02 | - | 645 | ||||||
Assets acquired under operating leases | 3,551 | 599 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
(formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD in thousands, except share and per share data)
NOTE 1 | – | GENERAL |
A. | General information: |
BiomX Inc. (formerly known as Chardan Healthcare Acquisition Corp., individually prior to the Recapitalization Transaction (as defined below), and together with its subsidiaries, BiomX Ltd. and RondinX Ltd. after the Recapitalization Transaction, the “Company” or “BiomX”) iswas incorporated as a newly organized blank check company incorporated in Delaware on November 1, 2017. The Company was formed2017, under the laws of the state of Delaware, for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business transactioncombination with one or more businesses or entities (a “Business Combination”). Althoughentities.
On July 16, 2019, the Company is not limitedentered into a merger agreement with BiomX Ltd. (“BiomX Israel”), a company incorporated under the laws of Israel, CHAC Merger Sub Ltd. (“Merger Sub”) and Shareholder Representative Services LLC (“SRS”), as amended on October 11, 2019, pursuant to which, among other things, BiomX Israel merged with Merger Sub, with BiomX Israel being the surviving entity in accordance with the Israeli Companies Law, 5759-1999, as a particular industry or geographic region for purposeswholly owned direct subsidiary of consummating a Business Combination, the Company intends to focus on businesses operating in North America in the healthcare industry.BiomX Inc.
At December 31, 2018, the Company had not yet commenced operations. All activity through December 31, 2018 relates to the Company’s formation, its initial public offering (“Initial Public Offering”) and identifying a target for a Business Combination.
The registration statement for the Initial Public Offering was declared effective on December 13, 2018. On December 18, 2018October 28, 2019, the Company consummated the Initial Public Offeringacquisition of 7,000,000 units (“Units” and, with respect100% of the outstanding shares of BiomX Israel (the “Recapitalization Transaction”). Pursuant to the common stock includedaforementioned merger agreement, in exchange for all of the outstanding shares of BiomX Israel, the Company issued to the shareholders of BiomX Israel a total of 15,069,058 shares of the Company’s Common Stock representing approximately 65% of the total shares issued and outstanding after giving effect to the Recapitalization Transaction. As a result of the Recapitalization Transaction, BiomX Israel became a wholly owned subsidiary of the Company. As the shareholders of BiomX Israel received the largest ownership interest in the Units offered,Company, BiomX Israel was determined to be the “Public Shares”) at $10.00 per Unit, generating total gross proceeds“accounting acquirer” in the Recapitalization Transaction. As a result, the historical financial statements of $70,000,000, which is described in Note 3.the Company were replaced with the financial statements of BiomX Israel for all periods presented.
Simultaneously with the closing of the Initial Public Offering, the Company consummated the sale of an aggregate of 2,900,000 warrants (the “Private Placement Warrants”) at a price of $0.40 per warrant in a private placement to Mountain Wood, LLC, an affiliate of Chardan Investments, LLC (the “Sponsor”), generating total gross proceeds of $1,160,000, which is described in Note 4.
Transaction costs amounted to $783,566, consisting of $500,000 of underwriting fees and $283,566 of offering costs. In addition, $896,729 of cash was held outside of the Trust Account (defined below) and is available for working capital purposes.
Following the closing ofRecapitalization Transaction, the Initial Public Offering on December 18, 2018, an amount of $70,000,000 ($10.00 per Unit) from the net proceeds of the sale of the Units in the Initial Public Offering and the sale of the Private Placement Warrants was placedCompany retained $60.1 thousand held in a trust account, (“Trust Account”) and investedafter redemptions of a portion of shares of Common Stock issued in U.S. government securities, within the meaning set forth in Section 2(a)(16)initial public offering of the Investment Company Act of 1940, as amended (the “Investment Company Act”), with a maturity of 180 days or less or in any open-ended investment company that holds itself out as a money market fund selectedand held by the Company meeting the conditions of Rule 2a-7 of the Investment Company Act, as determined by the Company, until the earlier of: (i) the consummation of a Business Combination or (ii) the distribution of the funds in the Trust Account to the Company’s shareholders, as described below.certain shareholders.
The numbers of shares and instruments convertible into shares included within these financial statements have been retroactively adjusted based on the equivalent number of shares received by the accounting acquirer in the Recapitalization Transaction.
On October 28, 2019, the Company was renamed BiomX Inc. and the Company’s shares of Common Stock, units, and warrants began trading in NYSE American under the symbols PHGE, PHGE.U, and PHGE.WS, respectively.
On February 6, 2020, the Company’s Common Stock also began trading on the Tel Aviv Stock Exchange.
B. | Risk factors: |
To date, the Company has not generated revenue from its operations. As of September 30, 2020, the Company had a cash and cash equivalents and restricted cash balance of approximately $54 thousand and short-term deposits of approximately $10 thousand, which management has broad discretionbelieves is sufficient to fund its operations for more than 12 months from the date of issuance of these condensed consolidated financial statements and sufficient to fund its operations necessary to continue development activities of its current proposed products.
Consistent with respectits continuing R&D activities, the Company expects to continue to incur additional losses for the foreseeable future. The Company plans to continue to fund its current operations, as well as other development activities relating to additional product candidates, through future issuances of debt and/or equity securities and possibly additional grants from the Israel Innovation Authority (“IIA”) or other government or non-for-profit institutions. The Company’s ability to raise additional capital in the equity and debt markets is dependent on a number of factors including, but not limited to, the specific applicationmarket demand for the Company’s Common Stock, which itself is subject to a number of development and business risks and uncertainties, as well as the net proceeds of the Initial Public Offering and the sale of the Private Placement Warrants, although substantially all of the net proceeds are intended to be applied generally toward consummating a Business Combination. The Company’s initial Business Combination must be with one or more target businesses that together have a fair market value equal to at least 80% of the balance in the Trust Account (excluding taxes payable on income earned on the Trust Account) at the time of the signing an agreement to enter into a Business Combination. The Company will only complete a Business Combination if the post-Business Combination company owns or acquires 50% or more of the outstanding voting securities of the target or otherwise acquires a controlling interest in the target sufficient for it not to be required to register as an investment company under the Investment Company Act of 1940, as amended, or the Investment Company Act. There is no assuranceuncertainty that the Company willwould be able to successfully effectraise such additional capital at a Business Combination.price or on terms that are favorable to it.
The Company will provide its stockholders with the opportunity to redeem all or a portion of their Public Shares upon the completion of a Business Combination either (i) in connection with a stockholder meeting called to approve the Business Combination or (ii) by means of a tender offer. The decision as to whether the Company will seek stockholder approval of a Business Combination or conduct a tender offer will be made by the Company, solely in its discretion. The stockholders will be entitled to redeem their shares for a pro rata portion of the amount then on deposit in the Trust Account ($10.00 per share, plus any pro rata interest earned on the funds held in the Trust Account and not previously released to the Company to pay its franchise and income tax obligations). There will be no redemption rights upon the completion of a Business Combination with respect to the Company’s warrants.
The Company will proceed with a Business Combination if the Company has net tangible assets of at least $5,000,001 upon such consummation of a Business Combination and, if the Company seeks stockholder approval, a majority of the outstanding shares voted are voted in favor of the Business Combination. If a stockholder vote is not required by law and the Company does not decide to hold a stockholder vote for business or other legal reasons, the Company will, pursuant to its Amended and Restated Certificate of Incorporation, conduct the redemptions pursuant to the tender offer rules of the Securities and Exchange Commission (“SEC”), and file tender offer documents with the SEC prior to completing a Business Combination. If, however, a stockholder approval of the transaction is required by law, or the Company decides to obtain stockholder approval for business or other legal reasons, the Company will offer to redeem shares in conjunction with a proxy solicitation pursuant to the proxy rules and not pursuant to the tender offer rules. Additionally, each public stockholder may elect to redeem their Public Shares irrespective of whether they vote for or against the proposed transaction. If the Company seeks stockholder approval in connection with a Business Combination, the Company’s Sponsor and other initial stockholders (collectively, the “Initial Stockholders”) have agreed to (a) vote their Founder Shares (as defined in Note 5) and any Public Shares held by them in favor of a Business Combination and (b) not to convert any shares (including Founder Shares) in connection with a stockholder vote to approve a Business Combination or sell any such shares to the Company in a tender offer in connection with a Business Combination.
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
CHARDAN HEALTHCARE ACQUISITION CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2018
(Unaudited)
(USD in thousands, except share and per share data)
Notwithstanding the foregoing, if the Company seeks stockholder approval of a Business Combination and the Company does not conduct redemptions pursuant to the tender offer rules, a stockholder, together with any affiliate of such stockholder or any other person with whom such stockholder is acting in concert or as a “group” (as defined in Section 13(d)(3) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), will be restricted from redeeming their shares with respect to more than an aggregate of 20% of the Public Shares.
NOTE 2 | – | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
The Company will have until December 18, 2020 to consummate a Business Combination (the “Combination Period”). If the Company is unable to complete a Business Combination within the Combination Period, the Company will (i) cease all operations except for the purpose of winding up, (ii) as promptly as reasonably possible but no more than five business days thereafter, redeem 100% of the outstanding Public Shares, at a per share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account, including interest earned (net of taxes payable), divided by the number of then outstanding Public Shares, which redemption will completely extinguish public stockholders’ rights as stockholders (including the right to receive further liquidation distributions, if any), subject to applicable law, and (iii) as promptly as reasonably possible following such redemption, subject to the approval of the remaining stockholders and the Company’s board of directors, proceed to commence a voluntary liquidation and thereby a formal dissolution of the Company, subject in each case to its obligations to provide for claims of creditors and the requirements of applicable law. The proceeds deposited in the Trust Account could, however, become subject to claims of creditors. Therefore, the actual per-share redemption amount could be less than $10.00 per Unit.
The Initial Stockholders have agreed to (i) waive their redemption rights with respect to Founder Shares and any Public Shares they may acquire during or after the Initial Public Offering in connection with the consummation of a Business Combination, (ii) to waive their rights to liquidating distributions from the Trust Account with respect to their Founder Shares if the Company fails to consummate a Business Combination within the Combination Period and (iii) not to propose an amendment to the Company’s Amended and Restated Certificate of Incorporation that would affect the substance or timing of the Company’s obligation to redeem 100% of its Public Shares if the Company does not complete a Business Combination, unless the Company provides the public stockholders an opportunity to redeem their Public Shares in conjunction with any such amendment. However, the Initial Stockholders will be entitled to liquidating distributions with respect to any Public Shares acquired if the Company fails to consummate a Business Combination or liquidates within the Combination Period.
In order to protect the amounts held in the Trust Account, the Sponsor has agreed to be liable to the Company if and to the extent any claims by a vendor for services rendered or products sold to the Company, or a prospective target business with which the Company has discussed entering into a transaction agreement, reduce the amount of funds in the Trust Account to below $10.00 per share, except as to any claims by a third party who executed a waiver of any right, title, interest or claim of any kind in or to any monies held in the Trust Account or to any claims under the Company’s indemnity of the underwriters of the Initial Public Offering against certain liabilities, including liabilities under the Securities Act of 1933, as amended (the “Securities Act”). Moreover, in the event that an executed waiver is deemed to be unenforceable against a third party, the Sponsor will not be responsible to the extent of any liability for such third party claims. The Company will seek to reduce the possibility that the Sponsor will have to indemnify the Trust Account due to claims of creditors by endeavoring to have all vendors, service providers, prospective target businesses or other entities with which the Company does business, execute agreements with the Company waiving any right, title, interest or claim of any kind in or to monies held in the Trust Account.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of presentation
A. | Unaudited Condensed Financial Statements |
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principlesU.S. generally accepted in the United States of Americaaccounting principles (“GAAP”) for interimcondensed financial information and in accordance with the instructions to Form 10-Q and Article 810 of Regulation S-X of the SEC. Certain information or footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting.S-X. Accordingly, they do not include all the information and footnotes necessaryrequired by GAAP for a complete presentation of financial position, results of operations, or cash flows.statements. In the opinion of management, the accompanying unaudited condensed financial statements include all adjustments consisting of a normal recurring nature, which areconsidered necessary for a fair presentation have been included (consisting only of the financial position, operating results and cash flows for the periods presented.normal recurring adjustments except as otherwise discussed).
The accompanying unaudited condensed financial statementsinformation contained in this report should be read in conjunction with the Company’s prospectus asAnnual Report on Form 10-K for the fiscal year ended December 31, 2019, that the Company filed with the SECU.S. Securities and Exchange Committee (the “SEC”) on December 14, 2018, as well as the Company’s Current Report on Form 8-K, as filed with the SEC on December 21, 2018. The interim results for the three and six months ended December 31, 2018 are not necessarily indicative of the results to be expected for the year ended June 30, 2019 or for any future interim periods.March 26, 2020.
CHARDAN HEALTHCARE ACQUISITION CORP.
NOTES TO CONDENSED FINANCIAL STATEMENTS
DECEMBER 31, 2018
(Unaudited)
The Company had no activity for the period from November 1, 2017 (inception) through December 31, 2017. Accordingly, the condensed statement of operations and condensed statement of cash flow for the comparative period from November 1, 2017 (inception) through December 31, 2017 are not presented.
Emerging growth company
The Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and it may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Exchange Act) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of the Company’s financial statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.
Use of estimates
B. | Use of estimates in the preparation of financial statements |
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date ofin the financial statements and the reported amounts of revenues and expenses during the reporting period.
Making estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of circumstances that existed at the date of the financial statements, which management considered in formulating its estimate, could change in the near term due to one or more future confirming events. Accordingly, the actualreported years. Actual results could differ significantly from those estimates.
C. | Reclassification |
Cash and cash equivalents
Certain prior year amounts have been reclassified to conform to the current year presentation.
D. | Significant Accounting Policies |
The significant accounting policies followed in the preparation of these unaudited condensed consolidated financial statements are identical to those applied in the preparation of the latest annual audited financial statements with the exception of the following:
In August 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2018-13, “Changes to Disclosure Requirements for Fair Value Measurements,” which will improve the effectiveness of disclosure requirements for recurring and nonrecurring fair value measurements. The standard removes, modifies, and adds certain disclosure requirements and is effective for the Company considers all short-term investments with an original maturity of three months or less when purchased to be cash equivalents. The Companybeginning on January 1, 2020. This standard did not have any cash equivalents as of December 31, 2018a material impact on the Company’s condensed consolidated financial statements and June 30, 2018.related disclosures.
Marketable securities heldIn November 2018, the FASB issued ASU No. 2018-18, “Collaborative Arrangements (Topic 808),” which clarifies the interaction between Topic 808 and Topic 606, “Revenue from Contracts with Customers”. The Company adopted this standard in Trust Accountthe first quarter of fiscal year 2020. This standard did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures.
At
E. | Recent Accounting Standards: |
In June 2016, FASB issued ASU No. 2016-13, “Financial Instruments – Credit Losses”, to improve information on credit losses for financial assets and net investment in leases that are not accounted for at fair value through net income. The ASU replaces the current incurred loss impairment methodology with a methodology that reflects expected credit losses. This guidance is effective for the Company beginning on January 1, 2023, with early adoption permitted. The Company does not expect that the adoption of this standard will have a significant impact on its condensed consolidated financial statements and related disclosures.
In December 31, 2018, substantially all2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes” (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for the Company beginning on January 1, 2021, with early adoption permitted. The Company does not expect that the adoption of this standard will have a significant impact on its condensed consolidated financial statements and related disclosures.
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD in thousands, except share and per share data)
F. | Foreign exchange risk management |
The Company uses foreign exchange contracts (mainly option and forward contracts) to hedge cash flows from currency exposure. These foreign exchange contracts are not designated as hedging instruments for accounting purposes. In connection with these foreign exchange contracts, the Company recognizes gains or losses that offset the revaluation of the assets heldcash flows also recorded under financial expenses (income), net in the Trust Account were heldcondensed consolidated statements of operations. As of September 30, 2020, the Company had outstanding foreign exchange contracts in U.S. Treasury Bills.the amount of approximately $3.5 thousand. As of September 30, 2019, the Company had no outstanding foreign exchange contracts.
Common stock subject to possible redemption
I. | Fair value of financial instruments: |
The Company accounts for its common stock subject to possible redemptionfinancial instruments in accordance with the guidance in Accounting Standards Codification (“ASC”) Topic 480 “Distinguishing Liabilities from Equity.” Common stock subject to mandatory redemption is classified as a liability instrument and is measured at fair value. Conditionally redeemable common stock (including common stock that features redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) is classified as temporary equity. At all other times, common stock is classified as stockholders’ equity. The Company’s common stock features certain redemption rights that are considered to be outside of the Company’s control and subject to occurrence of uncertain future events. Accordingly, at December 31, 2018, common stock subject to possible redemption is presented at redemption value as temporary equity, outside of the stockholders’ equity section of the Company’s balance sheet.
CHARDAN HEALTHCARE ACQUISITION CORP.
NOTES TO CONDENSED FINANCIAL STATEMENTS
DECEMBER 31, 2018
(Unaudited)
Income taxes
The Company complies with the accounting and reporting requirements of ASC Topic 740 “Income Taxes,” which requires an asset and liability approach to financial accounting and reporting for income taxes. Deferred income tax assets and liabilities are computed for differences between the financial statement and tax bases of assets and liabilities that will result in future taxable or deductible amounts, based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized.
ASC Topic 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. The Company recognizes accrued interest and penalties related to unrecognized tax benefits as income tax expense. As of December 31, 2018 and June 30, 2018, there were no unrecognized tax benefits and no amounts accrued for interest and penalties. The Company is currently not aware of any issues under review that could result in significant payments, accruals or material deviation from its position.
The Company may be subject to potential examination by federal, state and city taxing authorities in the areas of income taxes. These potential examinations may include questioning the timing and amount of deductions, the nexus of income among various tax jurisdictions and compliance with federal, state and city tax laws. The Company’s management does not expect that the total amount of unrecognized tax benefits will materially change over the next twelve months.
Net loss per common share
Net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. The Company applies the two-class method in calculating earnings per share. Shares of common stock subject to possible redemption at December 31, 2018, which are not currently redeemable and are not redeemable at fair value, have been excluded from the calculation of basic loss per share since such shares, if redeemed, only participate in their pro rata share of the Trust Account earnings. The Company has not considered the effect of warrants sold in the Initial Public Offering and private placement to purchase 6,400,000 shares of common stock in the calculation of diluted loss per share, since the exercise of the warrants is contingent upon the occurrence of future events. As a result, diluted loss per common share is the same as basic loss per common share for the periods.
Reconciliation of net loss per common share
The Company’s net income is adjusted for the portion of income that is attributable to common stock subject to possible redemption, as these shares only participate in the earnings of the Trust Account and not the income or losses of the Company. Accordingly, basic and diluted loss per common share is calculated as follows:
Three Months Ended December 31, | Six Months Ended December 31, | |||||||
2018 | 2018 | |||||||
Net income | $ | 10,458 | $ | 9,808 | ||||
Less: Income attributable to common stock subject to redemption | (19,353 | ) | (19,353 | ) | ||||
Adjusted net loss | $ | (8,895 | ) | $ | (9,545 | ) | ||
Weighted average shares outstanding, basic and diluted | 1,815,004 | 1,782,502 | ||||||
Basic and diluted net loss per share | $ | (0.00 | ) | $ | (0.01 | ) |
Concentration of credit risk
Financial instruments that potentially subject the Company to concentration of credit risk consist of cash accounts in a financial institution, which, at times may exceed the Federal Depository Insurance Coverage of $250,000. At December 31, 2018 and June 30 2018, the Company had not experienced losses on these accounts and management believes the Company is not exposed to significant risks on such accounts.
CHARDAN HEALTHCARE ACQUISITION CORP.
NOTES TO CONDENSED FINANCIAL STATEMENTS
DECEMBER 31, 2018
(Unaudited)
Fair Value of financial instruments
The fair value of the Company’s assets and liabilities, which qualify as financial instruments under ASC 820, “Fair Value Measurements and Disclosures,” approximatesDisclosures” (“ASC 820”). ASC 820 establishes a fair value hierarchy that prioritizes the carrying amounts representedinputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described below:
Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
Level 2 – Quoted prices in non-active markets or in active markets for similar assets or liabilities, observable inputs other than quoted prices, and inputs that are not directly observable but are corroborated by observable market data.
Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
There were no changes in the accompanying condensed balance sheet, primarilyfair value hierarchy levelling during the period ended September 30, 2020 and year ended December 31, 2019.
The following table summarizes the fair value of our financial assets and liabilities that were accounted for at fair value on a recurring basis, by level within the fair value hierarchy:
September 30, 2020 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Fair Value | |||||||||||||
Assets: | ||||||||||||||||
Cash equivalents: | ||||||||||||||||
Money market funds | 30,000 | - | - | 30,000 | ||||||||||||
30,000 | - | - | 30,000 | |||||||||||||
Liabilities: | ||||||||||||||||
Contingent liabilities | - | - | 701 | 701 | ||||||||||||
- | - | 701 | 701 |
December 31, 2019 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Fair Value | |||||||||||||
Assets: | ||||||||||||||||
Cash equivalents: | ||||||||||||||||
Money market funds | - | - | - | - | ||||||||||||
- | - | - | - | |||||||||||||
Liabilities: | ||||||||||||||||
Contingent liabilities | - | - | 585 | 585 | ||||||||||||
- | - | 585 | 585 |
Financial instruments with carrying values approximating fair value include cash and cash equivalents, restricted cash, short-term deposits, other current assets, trade accounts payable and other current liabilities, due to their short-term nature.
Recently issued accounting standards
10
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD in thousands, except share and per share data)
NOTE 3 | – | SHORT-TERM DEPOSITS |
Short-term deposits represent time deposits placed with banks with original maturities of greater than three months but less than one year. Interest earned is recorded as financial income in the condensed consolidated statements of operations during the periods for which the Company held short-term deposits.
Management does not believe that any recently issued, but not yet effective, accounting pronouncements, if currentlyAs of September 30, 2020, the Company had deposits dominated in New Israeli Shekels (“NIS”) and in USD at Leumi Bank (Israel) and BHI USA with various fixed annual interest rates in the range of 0.5% - 1.58% per year. As of September 30, 2019, the Company had deposits at Leumi Bank (Israel) and BHI USA with various fixed annual interest rates in the range of 2.4% - 3.6% per year.
NOTE 4 | – | LEASES |
On January 1, 2019, the Company adopted would haveASU No. 2016-02, “Leases (Topic 842)” using the modified retrospective approach for all lease arrangements at the beginning period of adoption. The Company leases office space under operating leases. As of September 30, 2020, the Company’s right-of-use assets and lease liabilities for operating leases totaled $4,370 and $4,499, respectively.
In May 2017, BiomX Israel entered into a material effectlease agreement for office space in Ness Ziona, Israel for five years, beginning on June 1, 2017, with an option to extend for an additional five years. Monthly lease payments under the agreement are approximately $18. As part of the agreement, the Company has obtained a bank guarantee in favor of the property owner in the amount of approximately $95, representing four monthly lease and related payments. Lease expenses recorded in the condensed consolidated statements of operations were $55 and $163 for the three and nine months ended September 30, 2020, respectively. Lease expenses recorded in the condensed consolidated statements of operations were $48 and $96 for the three and nine months ended September 30, 2019, respectively.
In September 2019, BiomX Israel entered into a lease agreement for office space in Ness Ziona, Israel for five years beginning on September 8, 2019, with an option to extend for an additional period until July 14, 2027. Monthly lease payments under the agreement are approximately $12. As part of the agreement, BiomX Israel obtained a bank guarantee in favor of the property owner in the amount of approximately $59, representing four monthly lease and related payments. Lease expenses recorded in the condensed consolidated statements of operations were $35 and $105 for the three and nine months ended September 30, 2020, respectively. Lease expenses recorded in the condensed consolidated statements of operations were $8 for the three and nine months ended September 30, 2019, respectively.
In September 2020, BiomX Israel entered into a lease agreement for office space in Ness Ziona, Israel for five years beginning on September 1, 2020, with an option to extend for an additional period until November 30, 2030. This agreement supersedes the above-mentioned May 2017 and September 2019 lease agreements and sets the prior lease agreements’ end date to March 31, 2021. Monthly lease payments under the new lease agreement are approximately $50. As part of the agreement, BiomX Israel is exempt from monthly payments under the new agreement until January 15, 2021. BiomX Israel undertook to obtain a bank guarantee in favor of the property owner in the amount of approximately $208, representing four monthly lease and related payments.
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD in thousands, except share and per share data)
NOTE 4 | – | LEASES (Cont.) |
Supplemental cash flow information related to operating leases was as follows:
Three months ended September 30, 2020 | Nine months ended September 30, 2020 | |||
Cash payments for operating leases | 90 | 268 |
As of September 30, 2020, the Company’s operating leases had a weighted average remaining lease term of 10. 2 years and a weighted average discount rate of 6%. Future lease payments under operating leases as of September 30, 2020 were as follows:
Operating Leases | ||||
Remainder of 2020 | $ | 95 | ||
2021 | $ | 651 | ||
2022 | $ | 580 | ||
2023 | $ | 580 | ||
2024 | $ | 580 | ||
2025 | $ | 580 | ||
2026 | $ | 580 | ||
2027 | $ | 580 | ||
2028 | $ | 580 | ||
2029 | $ | 580 | ||
2030 | $ | 532 | ||
Total future lease payments | $ | 5,918 | ||
Less imputed interest | (1,419 | ) | ||
Total lease liability balance | $ | 4,499 |
12
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD in thousands, except share and per share data)
NOTE 5 | – | ACQUISITION OF SUBSIDIARY |
In November 2017, BiomX Israel signed a share purchase agreement with the shareholders of RondinX Ltd. In accordance with the share purchase agreement, BiomX Israel acquired 100% control and ownership of RondinX Ltd. for consideration valued at $4.5 thousand. The consideration included the issuance of 250,023 Preferred A Shares, the issuance of warrants to purchase an aggregate of 4,380 Series A-1 preferred shares and additional contingent consideration. The contingent consideration is based on the Company’s condensed financial statements.
NOTE 3. INITIAL PUBLIC OFFERING
Pursuantattainment of future clinical, developmental, regulatory, commercial and strategic milestones relating to product candidates for the Initial Public Offering,treatment of primary sclerosing cholangitis or entry into qualifying collaboration agreements with certain third parties. The contingent consideration may require the Company sold 7,000,000 Units atto issue 567,729 shares of Common Stock upon the attainment of certain milestones, as well as make future cash payments and/or issue additional shares of the most senior class of the Company’s shares authorized or outstanding as of the time the payment is due, or a purchase pricecombination of $10.00 per Unit. Each Unit consistsboth of one share of common stock and one warrant (“Public Warrant”). Each Public Warrant entitles the holderup to purchase one-half of one share of common stock at an exercise price of $11.50 per whole share (see Note 7).
NOTE 4. PRIVATE PLACEMENT
Simultaneously with$32 thousand within ten years from the closing of the Initial Public Offering, Mountain Wood, LLC purchased an aggregate of 2,900,000 Private Placement Warrants at $0.40 per Private Placement Warrant, or $1,160,000 in the aggregate). Each Private Placement Warrant is exercisable toshare purchase one share of common stock at an exercise price of $11.50.agreement. The proceeds from the Private Placement Warrants were added to the proceeds from the Initial Public Offering held in the Trust Account. Ifcontingent consideration may also require the Company does not completeto pay a Business Combinationqualifying up-front fee upon entering of agreements with certain third parties or their affiliates within the Combination Period, the proceedsthree years from the sale of the Private Placement Warrants will be used to fund the redemption of the Public Shares (subject to the requirements of applicable law) and the Private Placement Warrants will expire worthless. There will be no redemption rights or liquidating distributions from the Trust Account with respect to the Private Placement Warrants.
NOTE 5. RELATED PARTY TRANSACTIONS
Founder Shares
In March 2018, the Company issued an aggregate of 1,437,500 shares of common stock to the Sponsor (“Founder Shares”) for an aggregate purchase price of $25,000. On September 14, 2018, the Company effectuated a 1.4-for-1 stock dividend resulting in an aggregate of 2,012,500 Founder Shares outstanding. The Founder Shares included an aggregate of up to 262,500 shares subject to forfeiture by the Sponsor to the extent that the underwriters’ over-allotment was not exercised in full or in part, so that the Sponsor would own 20% of the Company’s issued and outstanding shares after the Initial Public Offering (assuming the Sponsor did not purchase any Public Shares in the Initial Public Offering) (see Note 9).
The Initial Stockholders have agreed that, subject to certain limited exceptions, 50% of the Founder Shares will not be transferred, assigned, sold or released from escrow until the earlier of (i) 6 months after the date of the consummation of a Business Combination or (ii) the date on which the closing price of the Company’s shares of common stock equals or exceeds $12.50 per share (as adjusted for stock splits, stock dividends, reorganizations and recapitalizations) for any 20 trading days within any 30-trading day period commencing after a Business Combination and the remaining 50% of the Founder Shares will not be transferred, assigned, sold or released from escrow until 6 months after the date of the consummation of a Business Combination, or earlier, in either case, if, subsequent to a Business Combination, the Company consummates a subsequent liquidation, merger, stock exchange or other similar transaction which results in all of the stockholders having the right to exchange their shares of common stock for cash, securities or other property.
Promissory Notes – Related Party
The Company issued unsecured promissory notes (the “Promissory Notes”) to the Sponsor, pursuant to which the Company borrowed an aggregate of $105,500, of which $65,500 was borrowed during the six months ended December 31, 2018. The Promissory Notes were non-interest bearing and payable on the closing of the Initial Public Offering.share purchase agreement. The Promissory NotesCompany has the discretion of determining whether milestone payments will be made in cash or by issuance of shares.
There were repaid uponno changes in the consummationfair value hierarchy leveling during the nine months ended September 30, 2020 or 2019.
The change in the fair value of the Initial Public Offering on December 18, 2018.contingent consideration as of September 30, 2020 and 2019 was as follows:
Contingent consideration | ||||
As of December 31, 2019 | 585 | |||
Revaluation of contingent consideration | 116 | |||
As of September 30, 2020 | 701 |
On December 18,
Contingent consideration | ||||
As of December 31, 2018 | 889 | |||
Revaluation of contingent consideration | 20 | |||
As of September 30, 2019 | 909 |
NOTE 6 | – | IN-PROCESS RESEARCH AND DEVELOPMENT |
Intangible assets acquired in the Company issuedRondinX Ltd. acquisition (see Note 5) were determined to be in-process R&D. In accordance with ASC 350-30-35-17A (“Intangible assets with indefinite lives”), R&D assets acquired in a $500,000 promissory note to the Sponsor (the “Sponsor Promissory Note”) in exchange for $500,000 in cash that was used to pay the underwriting discount at the consummationbusiness combination are considered an indefinite-lived intangible asset until completion or abandonment of the Initial Public Offering.associated R&D efforts. On January 1, 2020, the in-process R&D efforts were completed. The Sponsor Promissory Note is non-interest bearing, unsecuredCompany had determined the useful life of the R&D assets for three years and due uponbegan amortizing these assets accordingly in the consummationfinancial statements. Amortization expenses recorded in the condensed consolidated statements of a Business Combination.operations were $379 and $1,137 for the three and nine months ended September 30, 2020, respectively. Based on management’s analysis, there was no impairment for the three and nine months ended September 30, 2020 and 2019.
BIOMX INC.
CHARDAN HEALTHCARE ACQUISITION CORP. (formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2018
(Unaudited)
(USD in thousands, except share and per share data)
NOTE 7 | – | COMMITMENTS AND CONTINGENT LIABILITIES |
Related Party Loans
A. | During 2015, 2016 and 2017, BiomX Israel submitted three applications to the IIA for an R&D project for the technological incubators program. The approved annual budget per application was NIS 2.7 thousand (approximately $726). According to the IIA directives, the IIA transferred to the Company 85% of the approved budget while the remainder of the budget was funded by certain shareholders. |
In orderDecember 2019, the IIA approved a new application for a total budget of NIS 10.8 thousand (approximately $3.1 thousand). IIA committed to finance transaction costs in connection withfunding 30% of the approved budget. The program is for the period beginning July 2019 through December 2019. BiomX Israel has not yet submitted the final report to the IIA for this program.
During April 2020, the IIA approved a Business Combination,new application for a total budget of NIS 15.6 thousand (approximately $4.4 thousand). The IIA committed to funding 30% of the Company’s initial stockholders, officers and directors or their affiliates may, but are not obligated to, loanapproved budget. The program is for the period beginning January 2020 through December 2020. As of September 30, 2020, the Company fundsreceived NIS 1.6 thousand (approximately $0.5 thousand) from timethe IIA with respect to time or at any time, asthis program.
According to the agreement with the IIA, BiomX Israel will pay royalties of 3% to 3.5% of future sales up to an amount equal to the accumulated grant received, including annual interest of LIBOR linked to the USD. BiomX Israel may be required (“Working Capital Loans”). Each Working Capital Loan would be evidencedto pay additional royalties upon the occurrence of certain events as determined by a promissory note. The Working Capital Loans would either be paid upon consummation of a Business Combination, without interest, or, at the holder’s discretion, up to $500,000IIA, that are within the control of the Working Capital Loans may be converted into private warrants at a priceCompany. No such events have occurred or were probable of $0.40 per private warrant. The private warrants would be identical to the Private Placement Warrants. In the event that a Business Combination does not close, the Company may use a portionoccurrence as of the proceeds held outside the Trust Account to repay the Working Capital Loans, but no proceeds held in the Trust Account would be used to repay the Working Capital Loans.
NOTE 6. COMMITMENTS AND CONTINGENCIES
Registration Rights
Pursuant to a registration rights agreement entered into on December 13, 2018, the holders of the Founder Shares, Private Placement Warrants (and their underlying securities) and any securities that may be issued upon conversion of the Working Capital Loans are entitled to registration rights. The holders of a majority of these securities are entitled to make up to two demands that the Company register such securities. The holders of the majority of the Founder Shares can elect to exercise these registration rights at any time commencing three months prior to thebalance sheet date on which these shares of common stock are to be released from escrow. The holders of a majority of the Private Placement Warrants (and their underlying securities) or securities issued in payment of Working Capital Loans made to the Company (in each case, including the underlying securities) can elect to exercise these registration rights at any time after the Company consummates a Business Combination. In addition, the holders will have certain “piggy-back” registration rights with respect to registration statements filed subsequentthese royalties. Repayment of the grant is contingent upon the successful completion of the Company’s R&D programs and generating sales. The Company has no obligation to repay these grants if the R&D program fails, is unsuccessful or aborted or if no sales are generated. The Company had not yet generated sales as of September 30, 2020, therefore, no liability was recorded in these condensed consolidated financial statements.
As of September 30, 2020, the Company had a contingent liability to the completionIIA in the amount of a Business Combination. The Company will bearapproximately $2.3 thousand including annual interest of LIBOR linked to the expenses incurred in connection with the filing of any such registration statements.USD.
Underwriters
B. | In June 2015, BiomX Israel entered into a Research and License Agreement (the “2015 License Agreement”) as amended with Yeda Research and Development Company Limited (“Yeda”), according to which Yeda undertakes to procure the performance of certain research, including proof-of-concept studies testing in-vivo phage eradication against a model bacteria in germ free mice, development of an inflammatory bowel disease (“IBD”) model in animals under germ-free conditions and establishing an in-vivo method for measuring immune induction capability (Th1) of bacteria, followed by testing several candidate IBD inducing bacterial strains during the research period, as defined in the 2015 License Agreement and subject to the terms and conditions specified in the 2015 License Agreement. BiomX Israel contributed an aggregate of approximately $1.8 thousand to the research budget agreed upon in the 2015 License Agreement. In addition, Yeda granted BiomX Israel an exclusive worldwide license for the development, production and sale of the products, as defined and subject to the terms and conditions specified in the 2015 License Agreement. In return, BiomX Israel will pay Yeda annual license fees of approximately $10 and royalties on revenues as defined in the 2015 License Agreement. In addition, in the event of certain mergers and acquisitions by the Company, Yeda will be entitled to an amount equivalent to 1% of the consideration received under such transaction (the “Exit Fee”), as adjusted per the terms of the 2015 License Agreement. In July 2019, the Company and Yeda amended the 2015 License Agreement and the 2017 License Agreement (as defined below) with Yeda (the “Yeda Amendment”). See Note 7H regarding the Yeda Amendment. As the Company has not yet generated revenue from operations, no provision was included in the condensed consolidated financial statements as of September 30, 2020 and December 31, 2019 with respect to the 2015 License Agreement. |
C. | In May 2017, BiomX Israel signed an additional agreement with Yeda (the “2017 License Agreement”), according to which Yeda provided a license to the Company. As consideration for the license, the Company will pay $10 over the term of the 2017 License Agreement, unless earlier terminated by either party, and granted Yeda 591,382 warrants to purchase shares of Common Stock. Refer to Note 8 below for the terms of the warrants granted. In addition, the 2017 License Agreement includes additional consideration contingent upon future sales or sublicensing revenue. As the Company has not yet generated revenue from operations, no provision was included in the condensed consolidated financial statements with respect to the 2017 License Agreement as of September 30, 2020 and December 31, 2019. |
In July 2019, the Company and Yeda amended the 2015 License Agreement and the 2017 License Agreement with Yeda. See Note 7H regarding the Yeda Amendment.
14
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD in thousands, except share and per share data)
NOTE 7 | – | COMMITMENTS AND CONTINGENT LIABILITIES (Cont.) |
D. | In April 2017, BiomX Israel signed an exclusive patent license agreement (the “2017 Patent License Agreement”) with the Massachusetts Institute of Technology (“MIT”) covering methods to synthetically engineer phage. According to the agreement, BiomX Israel received an exclusive, royalty-bearing license to certain patents held by MIT. In return, BiomX Israel paid an initial license fee of $25 during the year ended December 31, 2017 and is required to pay certain license maintenance fees of up to $250 in each subsequent year and following the commercial sale of licensed products. BiomX Israel is also required to make payments to MIT upon the satisfaction of development and commercialization milestones totaling up to $2.4 thousand in aggregate as well as royalty payments on future revenues. The condensed consolidated financial statements as of September 30, 2020 and December 31, 2019 include a liability with respect to this agreement in the amount of $240 and $108, respectively. In October 2020, the Company and MIT amended the 2017 Patent License Agreement (the “MIT Amendment”). See note 11B regarding the MIT Amendment. |
E. | As successor in interest to RondinX Ltd., BiomX Israel is a party to a license agreement dated March 20, 2016 with Yeda, pursuant to which BiomX Israel has a worldwide exclusive license to Yeda’s know-how, information and patents related to the Company’s meta-genomics target discovery platform. As consideration for the license, BiomX Israel will pay license fees of $10 subject to the terms and conditions of the agreement. Either party has the option to terminate the agreement at any time by way of notice to the other party as outlined in the agreement. In addition, the Company will pay a royalty in the low single digits on revenue of products. The condensed consolidated financial statements as of September 30, 2020 and December 31, 2019 include a liability with respect to this agreement in the amount of $83 and $260, respectively. |
F. | In December 2017, BiomX Israel signed a patent license agreement with Keio University and JSR Corporation in Japan. According to the agreement, BiomX Israel received an exclusive patent license to certain patent rights related to the Company’s IBD program. In return, the Company will pay an annual license fee of between $15 and $25 subject to the terms and conditions specified in the agreement. Additionally, the Company is obligated to make additional payments based upon the achievement of clinical and regulatory milestones up to an aggregate of $3.2 thousand and royalty payments based on future revenue. As the Company has not yet generated revenue from operations and the achievement of certain milestones is not probable, no provision was included in the condensed consolidated financial statements as of September 30, 2020 and December 31, 2019 with respect to the agreement. |
In April 2019, BiomX Israel signed an additional patent license agreement with Keio University and JSR Corporation in Japan. According to the agreement, BiomX Israel received an exclusive sublicense by JSR to certain patent rights related to the Company’s Primary Sclerosing Cholangitis program. In return, the Company is required (i) to pay a license issue fee of $20 and annual license fees ranging from $15 to $25 and (ii) make additional payments based upon the achievement of clinical and regulatory milestones up to an aggregate of $3.2 thousand and (iii) make tiered royalty payments, in the low single digits based on future revenue. The condensed consolidated financial statements include liabilities with respect to this agreement in the amount of $378 and $217 as of September 30, 2020 and December 31, 2019, respectively. |
G. | BiomX Israel entered into loan agreements with certain shareholders who were subject to taxation in Israel in connection with the Recapitalization Transaction. The loans are for a period of up to two years from the time of the grant, are non-recourse, and are secured by shares of Common Stock issued to them with a value that equals three times the loan amount at the time of the grant. If any of such shareholders defaults on such loan, the Company will have the right to forfeit or sell such number of shares with a value equal to the amount of the loan not timely repaid (plus interest accrued thereon), based on their market price at the time of such forfeiture or sale. As of September 30, 2020, one loan was granted in the amount of $19, and the aggregate amount of the remaining potential commitment as of September 30, 2020 is $89. All other shareholders waived their right to the loans. The number of shares of Common Stock in respect of which the $19 loan was granted was 5,700. The granting of the loan and the restrictions imposed on the related Common Stock until repayment of the loan were accounted as an acquisition of treasury stock by the Company at an amount equal to the loan. | |
H. | In July 2019, the Company and Yeda amended the 2015 License Agreement and the 2017 License Agreement with Yeda. Pursuant to the Yeda Amendment, following the closing of the Recapitalization Transaction, the provisions of the Yeda license agreements related to the exit fee were amended so that the Company is obligated to pay Yeda a one-time payment as described in the Yeda Amendment which will not exceed 1% of the consideration received in the event of any merger or acquisition involving the Company instead of the Exit Fee, with respect to each license agreement. | |
I. | On September 1, 2020 (“Effective Date”), BiomX Israel entered into a research collaboration agreement with Boehringer Ingelheim International GmbH (“BI”) for a collaboration on biomarker discovery for IBD. Under the agreement, BiomX Israel is eligible to receive fees totaling $439 in installments of $50 within 60 days of the Effective date, $100 upon receipt of the BI materials, $150 upon the completion of data processing and $139 upon delivery of the Final Report of observations and Results of the Project (as such terms are defined within the agreement). Unless terminated earlier, this agreement will remain in effect, until one year after the Effective Date or completion of the Project Plan (as defined in the agreement) and submission and approval of the Final Report. The research period started during September 2020. |
15
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD in thousands, except share and per share data)
NOTE 8 | – | SHAREHOLDERS EQUITY |
A. | Share Capital: |
Common Stock:
The Company grantedis authorized to issue 60,000,000 shares of Common Stock. Holders of the underwriters a 45-day optionCompany’s Common Stock are entitled to purchase up to 1,050,000 additional Units to cover over-allotments atone vote for each share. As of September 30, 2020, the Initial Public Offering price, less the underwriting discountsCompany had 23,173,378 issued shares and commissions. The over-allotment option expired unexercised on February 4, 2019 (see Note 9). 23,167,678 outstanding shares of Common Stock.
NOTE 7. STOCKHOLDER’S EQUITYShare Exchange:
As detailed in Note 1, as part of the Recapitalization Transaction on October 28, 2019, the Company issued 15,069,058 shares of Common Stock in exchange for approximately 65% of the issued and outstanding ordinary shares and all the preferred shares of BiomX Israel. The number of shares prior to the Recapitalization Transaction has been retroactively adjusted based on the equivalent number of shares received by the accounting acquirer in the Recapitalization Transaction.
In addition, the Company also agreed to issue the following number of additional shares of Common Stock, in the aggregate, to Chardan Healthcare Acquisition Corp. shareholders on a pro rata basis, subject to the Company’s achievement of the conditions specified below following the Recapitalization Transaction (all with respect to the Company’s shares of Common Stock traded on NYSE American):
A. | 2,000,000 additional shares of the Company’s Common Stock if the daily volume weighted average price of the Company’s Common Stock in any 20 trading days within a 30-trading day period prior to January 1, 2022 is greater than or equal to $16.50 per share. |
B. | 2,000,000 additional shares of the Company’s Common Stock if the daily volume weighted average price of the Company’s Common Stock in any 20 trading days within a 30-trading day period prior to January 1, 2024 is greater than or equal to $22.75 per share. |
C. | 2,000,000 additional shares of the Company’s Common Stock if the daily volume weighted average price of the Company’s Common Stock in any 20 trading days within a 30-trading day period prior to January 1, 2026 is greater than or equal to $29.00 per share. |
Preferred Stock —Stock:
The Company is authorized to issue 1,000,000 shares of preferred stock with a par value of $0.0001 per share with such designation, rights and preferences as may be determined from time to time by the Company’s Board of Directors. At December 31, 2018 and June 30, 2018, there were no shares of preferred stock issued or outstanding.
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
Common StockNOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS —
(USD in thousands, except share and per share data)
NOTE 8 | – | SHAREHOLDERS EQUITY (Cont.) |
B. | Share-based compensation: |
In 2015, the Board of Directors of BiomX Israel approved a plan for the allocation of options to employees, service providers and officers (the “2015 Plan”). The Company is authorizedoptions represented a right to issue 30,000,000 sharespurchase one ordinary share of common stock with a par value of $0.0001 per share. HoldersBiomX Israel in consideration of the Company’s common stock are entitled to one vote for each share. At December 31, 2018 and June 30, 2018, therepayment of an exercise price. The options were 2,473,414 and 2,012,500 shares of common stock issued and outstanding (excluding 6,539,086 and no shares of common stock subject to possible redemption, respectively), of which 262,500 shares were subject to forfeiture to the extent that the underwriter’s over-allotment option was not exercised in full so that the Company’s Initial Stockholders would own 20% of the issued and outstanding shares after the Initial Public Offering (assuming the Initial Stockholders did not purchase any Public Shares) (see Note 9).
Warrants — No fractional shares will be issued upon exercise of the Public Warrants. Therefore, Public Warrants must be exercised in multiples of two warrants. The Public Warrants will become exercisable on the consummation of a Business Combination; provided in that the Company has an effective and current registration statement covering the shares of common stock issuable upon the exercise of the Public Warrants and a current prospectus relating to such shares of common stock. The Company has agreed that as soon as practicable, the Company will use its best efforts to file with the SEC a registration statement for the registration, under the Securities Act, of the shares of common stock issuable upon exercise of the Public Warrants. The Company will use its best efforts to cause the same to become effective and to maintain the effectiveness of such registration statement, and a current prospectus relating thereto, until the expiration of the Public Warrantsgranted in accordance with the provisions“capital gains route” under section 102 and section 3(i) of the warrant agreement.Israeli Income Tax Ordinance and section 409A of the Israeli Internal Revenue Code.
The original 2015 Plan was adjusted following the Recapitalization Transaction on October 28, 2019 such that each outstanding option entitles its holder to purchase one share of Common Stock of the Company. As a result, the number of options and exercise price per share were adjusted in a technical manner such that there was no change in the fair value of the awards under the adjusted 2015 Plan. The number of outstanding options and exercise prices in this Note have been restated to reflect the adjusted 2015 Plan. As of September 30, 2020, there are no shares remaining for issuance under the 2015 Plan.
During 2019, the Board approved the grant of 704,669 options to 22 employees and 79,630 options to two consultants, without consideration. 527,716 of the options granted are to the executive officers of the Company. These options were granted under the 2015 Plan.
During 2019, 74,581 options were exercised to purchase shares of Common Stock at an average exercise price of $1.34 per share.
Certain senior employees and directors are entitled to full acceleration of their unvested options upon the occurrence of both a change in control of the Company and the end of their engagement with the Company.
In 2019, the Company adopted a new incentive plan (the “2019 Plan”) to grant 1,000 options, exercisable for Common Stock.
The aggregate number of shares of Common Stock that may be delivered pursuant to the 2019 Plan will automatically increase on January 1 of each year, commencing on January 1, 2020 and ending on (and including) January 1, 2029, in an amount equal to four percent (4%) of the total number of shares of Common Stock outstanding on December 31 of the preceding calendar year. Notwithstanding the foregoing, ifthe Board of Directors may act prior to January 1 of a registration statement coveringgiven year to provide that there will be no January 1 increase for such year or that the increase for such year will be a lesser number of Common Stock than provided herein. On January 1, 2020, the number of shares of common stock issuableCommon Stock available to grant under the 2019 Plan was increased by 914,741.
On March 25, 2020, the Board of Directors approved the grant of 814,700 options without consideration to 65 employees, one consultant, four senior officers (one of whom is a consultant), and six directors under the 2019 Plan. These options were granted at an exercise price of $6.21 per share with vesting periods ranging from three to four years. Directors and senior officers are entitled to full acceleration of their unvested options upon exercisethe occurrence of both a change in control of the public warrants is not effective within 120 days fromCompany and the closingend of a Business Combination, warrant holders may, until such time as there is an effective registration statement and during any period when we shall have failedtheir engagement with the Company.
On May 5, 2020, the Board of Directors approved the grant of 79,000 options without consideration to maintain an effective registration statement, exercise warrants on a cashless basis pursuant to an available exemption from registrationfour employees, under the Securities Act. If2019 Plan. These options were granted at an exemption from registrationexercise price of $5.59 per share with a vesting period of four years.
As of September 30, 2020, there were 48,041 shares available for issuance under the 2019 Plan. Refer to Note 11A for options granted on October 2, 2020.
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD in thousands, except share and per share data)
NOTE 8 | – | SHAREHOLDERS EQUITY (Cont.) |
B. | Share-based compensation: (Cont.) |
The fair value of each option was estimated as of the date of grant or reporting period using the Black-Scholes option-pricing model, using the following assumptions:
Nine months ended September 30, | ||||||||
2020 | 2019 | |||||||
Underlying value of share of Common Stock ($) | 5.59-6.21 | 2.03 | ||||||
Exercise price ($) | 5.59-6.21 | 2.03 | ||||||
Expected volatility (%) | 85.0 | 93.1 | ||||||
Term of the option (years) | 6.25 | 6.25 | ||||||
Risk-free interest rate (%) | 0.37-0.52 | 2.23 |
The cost of the benefit embodied in the options granted during the nine months ended September 30, 2020, based on their fair value at the grant date, is not available, holdersestimated to be $3.8 thousand. These amounts will not be able to exercise their warrants on a cashless basis. The Public Warrants will expire five years afterrecognized in the completioncondensed consolidated statements of a Business Combination or earlier upon redemption or liquidation.operations over the vesting period.
(1) | A summary of options granted to purchase the Company’s Common Stock under the Company’s share option plans is as follows: |
For the nine months ended September 30, 2020 | ||||||||||||
Number of Options | Weighted average exercise price | Aggregate intrinsic value | ||||||||||
USD | USD in thousands | |||||||||||
Outstanding at the beginning of period | 3,143,802 | 1.09 | 25,733 | |||||||||
Granted | 893,700 | 6.16 | ||||||||||
Forfeited | (61,110 | ) | 3.47 | |||||||||
Exercised | (304,843 | ) | 0.70 | |||||||||
Outstanding at the end of period | 3,671,549 | 3.08 | 12,665 | |||||||||
Vested at end of period | 1,738,957 | |||||||||||
Weighted average remaining contractual life – years as of September 30, 2020 | 7.82 |
CHARDAN HEALTHCARE ACQUISITION CORP.BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER(USD in thousands, except share and per share data)
NOTE 8 | – | SHAREHOLDERS EQUITY (Cont.) |
B. | Share-based compensation: (Cont.) |
Warrants:
As of September 30, 2020 and December 31, 20182019, the Company had the following outstanding warrants to purchase Common Stock as follows:
(Unaudited)
Warrant | Issuance Date | Expiration Date | Exercise Price Per Share (USD) | Number of Shares of Common Stock Underlying Warrants | ||||||||
Private Warrants issued to Yeda (see 1 below) | May 11, 2017 | May 11, 2025 | (* | ) | 591,382 | |||||||
Private Warrants issued to founders (see 2 below) | November 27, 2017 | - | 10,589 | |||||||||
Private Placement Warrants (see 3 below) | IPO (December 13, 2018) | December 13, 2023 | 11.50 | 2,900,000 | ||||||||
Public Warrants (see 4 below) | IPO (December 13, 2018) | October 28, 2024 | 11.50 | 3,500,000 | ||||||||
7,001,971 |
(*) | less than $0.001. |
1. | In May 2017, in accordance with the 2017 License Agreement (see also Note 7C), BiomX Israel issued 591,382 warrants to Yeda to purchase Common Stock at $0.0001 nominal value, for nominal consideration. No expenses or income were recorded in R&D expenses, net in the condensed consolidated statements of comprehensive loss for the nine months ended September 30, 2020 and 2019. |
236,552 warrants were fully vested and exercisable on the date of their issuance. The remainder of the warrants will vest and become exercisable subject to achievement of certain milestones specified in the agreement as follows:
a. | 177,414 upon the filing of a patent application covering any Discovered Target or a Product (both as defined in the 2017 License Agreement). |
b. | 118,277 upon achievement of the earlier of the following milestones by the Company: |
(i) | execution of an agreement with a pharmaceutical company with respect to the commercialization of any of the Company’s licensed technology or the Consulting IP or a Product (both defined in the 2017 License Agreement); or |
(ii) | the filing of a patent application covering any Discovered Target (as defined in the 2017 License Agreement) or a Product. |
c. | 59,139 upon completion of a Phase 1 clinical trial in respect of a Product (as defined in the 2017 License Agreement). |
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD in thousands, except share and per share data)
NOTE 8 | – | SHAREHOLDERS EQUITY (Cont.) |
B. | Share-based compensation: (Cont.) |
2. | In November 2017, BiomX Israel issued 7,615 warrants to Yeda and 2,974 warrants to its founders. All the warrants were fully vested at their grant date and will expire immediately prior to a consummation of an M&A transaction. The warrants did not expire as a result of the Recapitalization Transaction and have no exercise price. |
3. | The Private Placement Warrants are identical to the Public Warrants underlying the Units sold in the Company initial public offering, except that the Private Placement Warrants are exercisable for cash (even if a registration statement covering the shares of Common Stock issuable upon exercise of such warrants is not effective) or on a cashless basis, at the holder’s option, and will not be redeemable by the Company, in each case, so long as they are held by the initial purchasers or their permitted transferees. If the Private Placement Warrants are held by someone other than the initial purchasers or their permitted transferees, the Private Placement Warrants will be redeemable by the Company and exercisable by such holders on the same basis as the Public Warrants. The Company filed a Registration Statement on Form S-1 for the resale of shares underlying the warrants on December 13, 2019, which was declared effective on January 3, 2020. |
4. | The Public Warrants became exercisable upon the closing of the Recapitalization Transaction. No fractional shares will be issued upon exercise of the Public Warrants. Therefore, Public Warrants must be exercised in multiples of two warrants. The Public Warrants will expire five years after the completion of the Recapitalization Transaction or earlier upon redemption or liquidation. The Company filed a Registration Statement on Form S-1 for the resale of shares underlying the warrants on December 13, 2019, which was declared effective on January 3, 2020. |
The Company may redeem the Public Warrants:
● | in whole and not in part; | |
● | at a price of $0.01 per warrant; | |
● | at any time during the exercise period; | |
● | upon a minimum of 30 days’ prior written notice of redemption; | |
● | if, and only if, the last sale price of the Company’s | |
● | if, and only if, there is a current registration statement in effect with respect to the shares of |
If the Company calls the Public Warrants for redemption, management will have the option to require all holders that wish to exercise the Public Warrants to do so on a “cashless basis,” as described in the warrant agreement. The exercise price and number of shares of common stockCommon Stock issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend, or recapitalization, reorganization, merger or consolidation. However, the warrants will not be adjusted for issuance of common stockCommon Stock at a price below its exercise price. Additionally, in no event will the Company be required to net cash settle the warrants. If the Company is unable to complete a Business Combination within the Combination Period and the Company liquidates the funds held in the Trust Account, holders of warrants will not receive any of such funds with respect to their warrants, nor will they receive any distribution from the Company’s assets held outside of the Trust Account with the respect to such warrants. Accordingly, the warrants may expire worthless.
The Private Placement Warrants are identical to the Public Warrants underlying the Units sold
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD in the Initial Public Offeringthousands, except that the Private Placement Warrants are exercisable for cash (even if a registration statement covering the shares of common stock issuable upon exercise of such warrants is not effective) or on a cashless basis, at the holder’s option,share and will not be non-redeemable by the Company, in each case, so long as they are held by the initial purchasers or their permitted transferees. If the Private Placement Warrants are held by someone other than the initial purchasers or their permitted transferees, the Private Placement Warrants will be redeemable by the Company and exercisable by such holders on the same basis as the Public Warrants.per share data)
NOTE 8. FAIR VALUE MEASUREMENTS
The Company follows the guidance in ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and non-financial assets and liabilities that are re-measured and reported at fair value at least annually.
The fair value of the Company’s financial assets and liabilities reflects management’s estimate of amounts that the Company would have received in connection with the sale of the assets or paid in connection with the transfer of the liabilities in an orderly transaction between market participants at the measurement date. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of observable inputs (market data obtained from independent sources) and to minimize the use of unobservable inputs (internal assumptions about how market participants would price assets and liabilities). The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used in order to value the assets and liabilities:
NOTE 8 | – | SHAREHOLDERS EQUITY (Cont.) |
Nine months ended September 30, | ||||||||
2020 | 2019 | |||||||
Research and development expenses, net | 1,345 | 520 | ||||||
General and administrative | 783 | 360 | ||||||
2,128 | 880 |
Three months ended September 30, | ||||||||
2020 | 2019 | |||||||
Research and development expenses, net | 843 | 153 | ||||||
General and administrative | 271 | 96 | ||||||
1,114 | 249 |
NOTE 9 | – | RELATED PARTIES |
On October 31, 2018, BiomX Israel entered into a research collaboration agreement with Janssen Research & Development, LLC (“Janssen”), an affiliate of shareholder Johnson & Johnson Development Corporation, for a collaboration on biomarker discovery for IBD. Under the agreement, BiomX Israel was eligible to receive fees totaling $167 in installments of $50 within 60 days of signing of the agreement, $17 upon completion of data processing and two installments of $50 each upon delivery of Signature Phase I of the Final Study Report (both terms defined within the agreement). This agreement was in effect until 30 days after the parties completed the research program and BiomX Israel provided Janssen with a final study report. The research period started during March 2019 and ended in September 2019. The final report was provided to Janssen in December 2019.
BIOMX INC.
(formerly known as Chardan Healthcare Acquisition Corp.)
CHARDAN HEALTHCARE ACQUISITION CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2018(USD in thousands, except share and per share data)
(Unaudited)
NOTE 10 | – | BASIC LOSS PER SHARE |
The following table presents information aboutbasic and diluted net loss per share and weighted average number of shares of Common Stock used in the Company’s assets thatcalculation of basic and diluted net loss per share are measured at fair value on a recurring basis at December 31, 2018, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:as follows:
Description | Level | December 31, 2018 | |||||
Assets: | |||||||
Marketable securities held in Trust Account | 1 | $ | 70,034,459 |
Nine months ended September 30, | ||||||||
2020 | 2019 | |||||||
Net loss | 20,942 | 11,263 | ||||||
Interest accrued on preferred shares (pre-merger – BiomX Israel) | - | 3,594 | ||||||
Net loss used in the calculation of basic net loss per share | 20,942 | 14,857 | ||||||
Net loss per share | 0.91 | 7.37 | ||||||
Weighted average number of shares of Common Stock | 23,013,790 | 2,015,349 |
Three months ended September 30, | ||||||||
2020 | 2019 | |||||||
Net loss | 8,835 | 4,260 | ||||||
Interest accrued on preferred shares (pre-merger – BiomX Israel) | - | 1,212 | ||||||
Net loss used in the calculation of basic net loss per share | 8,835 | 5,472 | ||||||
Net loss per share | 0.38 | 2.69 | ||||||
Weighted average number of shares of Common Stock | 23,150,253 | 2,035,625 |
NOTE 11 | – | SUBSEQUENT EVENTS |
A. | On October 2, 2020, the Company’s Board of Directors approved the grant of 32,000 options without consideration to two directors under the 2019 Plan. These options were granted at an exercise price of $6.44 per share with a vesting period of four years. Directors are entitled to full acceleration of their unvested options upon the occurrence of both a change in control of the Company and the end of their engagement with the Company. |
B. | In October 2020, the Company and MIT amended the 2017 Patent License Agreement. Pursuant to the MIT Amendment, BiomX Israel will continue to receive an exclusive, royalty-bearing license to certain patents held by MIT. In return, BiomX Israel is required to pay certain license maintenance fees of up to $250 in each subsequent year and following the commercial sale of licensed products. BiomX Israel is also required to make payments to MIT upon the satisfaction of development and commercialization milestones totaling up to $4.7 thousand in aggregate, as well as royalty payments on future revenues. |
C. | On October 1, 2020, the Company entered into a lease agreement for office space in Branford, Connecticut for 25 months beginning on October 5, 2020. Monthly lease payments under the agreement are approximately $4. As part of the agreement, the Company is required to deposit $8 as a security, representing two monthly lease and related payments. |
NOTE 9. SUBSEQUENT EVENTS
22
The Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued. Other than as described below, the Company did not identify any subsequent events that would have required adjustment or disclosure in the financial statements.
The underwriters over-allotment option expired unexercised on February 4, 2019. As such, 262,500 Founder Shares were forfeited and there are now 1,750,000 Founder Shares issued and outstanding.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
References in this report (the “Quarterly Report”)Quarterly Report to “we,” “us” or“us,” the “Company” or similar words refer to Chardan Healthcare Acquisition Corp. References to our “management” or our “management team” refer to our officersthe combined company, BiomX Inc. When this Quarterly Report references “BiomX” and directors, and referencesdescribes the business of BiomX, it refers to the “Sponsor” refer to Chardan Investments, LLC.business of BiomX Ltd., an Israeli company and wholly-owned subsidiary of the Company, and RondinX Ltd., an Israeli company and wholly-owned subsidiary of BiomX Ltd. The financial statements included in this Quarterly Report show the condensed consolidated balances and transactions of the Company and BiomX and show comparative financial information of BiomX (the acquirer in a reverse merger for accounting purposes). The following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction with the financial statements and the notes thereto contained elsewhere in this Quarterly Report. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties.
Special Note Regarding Forward-Looking StatementsPursuant to a merger agreement dated as of July 16, 2019 and amended as of October 11, 2019, among other things, CHAC Merger Sub Ltd., an Israeli company and wholly owned subsidiary of the Company, merged with and into BiomX, with BiomX continuing as the surviving entity and a wholly-owned subsidiary of the Company (the “Recapitalization Transaction”). The Recapitalization Transaction was treated as a “reverse merger” in accordance with GAAP. For accounting purposes, BiomX was considered to have acquired the Company. Therefore, for accounting purposes, the Recapitalization Transaction was treated as the equivalent of a capital transaction in which BiomX issued stock for the net assets of the Company. The net assets of the Company were stated at historical cost with no goodwill or other intangible assets recorded. The post-acquisition financial statements of the Company show the consolidated balances and transactions of the Company and BiomX as well as comparative financial information of BiomX (the acquirer for accounting purposes).
This Quarterly Report includes “forward-looking statements”General
We are a clinical company developing products using both natural and engineered phage technologies designed to target and destroy bacteria that affect the appearance of skin, as well as harmful bacteria in chronic diseases, such as inflammatory bowel disease (“IBD”), Cystic Fibrosis (“CF”), Atopic Dermatitis (“AD”), primary sclerosing cholangitis (“PSC”) and colorectal cancer (“CRC”). Bacteriophage or phage are viruses that target bacteria and are considered inert to mammalian cells. By developing proprietary combinations of naturally occurring phage and by creating novel phage using synthetic biology, we develop phage-based therapies intended to address large-market and orphan diseases.
Since inception in 2015, we have devoted substantially all our resources to organizing and staffing the company, raising capital, acquiring rights to or discovering product candidates, developing our technology platforms, securing related intellectual property rights, and conducting discovery, research and development activities for our product candidates. We do not have any products approved for sale, our products are still in the preclinical and clinical development stages, and we have not generated any revenue from product sales. As we move our product candidates from preclinical to clinical stage and continue with clinical trials, we expect our expenses to increase.
On November 12, 2020, we announced our new BOLT (“BacteriOphage Lead to Treatment”) research and development platform. The BOLT platform will enable us to rapidly develop, manufacture and formulate phage therapy candidates targeting particular pathogenic bacteria and incorporates our experience over the past five years with process refinement and implementation of technological advancements. The BOLT platform is unique, employing cutting edge capabilities across disciplines including computational biology, microbiology, phage synthetic engineering, unique assay development, manufacturing and formulation, to allow agile and efficient development of phage therapies. For a given indication, the platform will allow for the completion of a clinical proof of concept study in patients, meaning Phase 2 results, within approximately 12-18 months from project initiation (in certain indications the meaninglength of Section 27Aclinical proof of concept may be longer depending on the indication, identity of target bacteria, recruitment rate, cohort size and other factors). The ability to move quickly into clinical development is also driven by the strong safety profile of naturally-occurring phage, as corroborated by regulatory guidance we received from the FDA relating to our IBD program, allowing us to bypass preclinical safety studies and studies in healthy volunteers and to proceed directly to patient studies. The platform allows generation of personalized phage treatments, tailored to target specific bacterial strains in a given patient, allowing us to conduct an initial clinical proof of concept study in patients (Phase 2 results) within approximately 12-18 months of project initiation for many indications, and, in parallel, also the development of an optimized phage therapy candidate with a fixed composition optimized for the treatment of a specific indication for the overall patient population. We are initially implementing the ability to complete a clinical proof of concept study in patients within approximately 12-18 months from project initiation in our cystic fibrosis and atopic dermatitis programs.
Clinical Developments
On March 31, 2020 we announced positive top line results from a randomized, double-blind, dose-finding, placebo-controlled single center Phase 1 cosmetic clinical study of BX001, a topical gel comprised of a cocktail of naturally-occurring phage targeting Cutibacterium acnes (“C. acnes”) to improve the appearance of acne-prone skin in subjects with acne-prone skin. C. acnes are bacteria implicated in the pathophysiology of acne vulgaris. The 75 enrolled individuals with mild-to-moderate acne were randomized into one of three cohorts: a high dose cohort, a low dose cohort, and a placebo cohort (vehicle). The study met its primary endpoint of safety and tolerability for both doses of BX001, as well as a statistically significant (p=0.036) reduction of C. acnes levels for the high dose of BX001 compared to placebo.
The Phase 2 cosmetic clinical study of BX001 is planned to be a 12-week randomized, double-blind, placebo-controlled trial in 100 individuals with mild-to-moderate acne. Enrolled individuals will be randomized into one of two cohorts: BX001 or placebo (vehicle). We plan to initiate the Phase 2 cosmetic clinical study of BX001 in the first quarter of 2021 and results are expected in the second quarter of 2021.
On November 3, 2020, the first subject has been dosed in a Phase 1a study of BX002, a phage therapy candidate for the treatment of IBD. The therapy targets strains of Klebsiella pneumoniae that cause strong TH1 immune stimulation and colitis in mouse models of disease and are known to be present at a higher prevalence and abundance in IBD patients relative to healthy individuals. The randomized, single-blind, multiple-dose, placebo-controlled study in 18 healthy volunteer subjects is designed to evaluate the safety and tolerability of orally administered BX002 as the primary endpoint, with detection of viable phage in stool as a key exploratory endpoint. The study is being conducted in the U.S. under a novel investigational new drug application approved by the FDA. Results from the study are expected in the first quarter of 2021.
On November 12, 2020, we announced the consolidation of two phage-therapy programs in IBD and PSC. We now have one improved, broad host range product candidate, BX003, targeting Klebsiella pneumoniae, a potential pathogen implicated in both diseases to be developed for both indications. The consolidation of these programs results in an updated timeline for Phase 1b/2a results with BX003, expected in mid-2022.
On November 12, 2020, we announced initiation of a new phage therapy program in CF addressing chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in these patients. Phase 2 results of a proof of concept clinical study evaluating safety and efficacy in patients are expected in the fourth quarter of 2021.
On November 12, 2020, we also announced the initiation of a new program for development of a topically administered phage-based product targeting Staphylococcus aureus, a bacterium linked to the development and exacerbation of inflammation in atopic dermatitis. Phase 2 results of a proof of concept clinical study evaluating safety and efficacy in patients are expected in the first half of 2022.
For our CRC program, we are exploring phage mediated delivery of therapeutic payloads to Fusobacterium nucleatum bacteria residing in the tumors of patients with colorectal cancer. Preclinical results from animal studies evaluating use of phage therapy in combination with checkpoint inhibitors are expected in the second quarter of 2021.
For more information regarding our product candidates, see Part I, Item 1 “Business—Overview of BiomX” of our 2019 Annual Report.
COVID-19
In December 2019, COVID-19 was reported to have surfaced in Wuhan, China and has since spread rapidly throughout many countries, and, on March 12, 2020, the World Health Organization declared COVID-19 a pandemic. In an effort to contain and mitigate the spread of COVID-19, many countries have imposed unprecedented restrictions on travel, and there have been business closures and a substantial reduction in economic activities in countries that have had significant outbreaks of COVID-19.
We have implemented recommended measures to safeguard the health and safety of our employees and clinical trial participants, and the continuity of our business operations. As of November 9, 2020, the COVID-19 pandemic has not had a material impact on our results of operation. However, uncertainty remains as to the potential impact of the Securities ActCOVID-19 pandemic on our future research and Section 21Edevelopment activities and during the second quarter of 2020 we updated our guidance on the timing of certain clinical milestones partly due to the health and safety precautions we have taken and challenges in clinical trial enrollment due to the COVID-19 pandemic. It is not currently possible to predict how long the pandemic will last or the time that it will take for economic activity to return to prior levels, and we do not yet know the full impact on our business and operations. We will continue to monitor the COVID-19 pandemic closely and follow health and safety guidelines as they evolve.
Consolidated Results of Operations
Comparison of the Exchange ActThree Months Ended September 30, 2020 and 2019
The following table summarizes our consolidated results of operations for the three months ended September 30, 2020 and 2019:
Three Months ended September 30, | ||||||||
2020 | 2019 | |||||||
USD in thousands | ||||||||
Research and development (“R&D”) expenses, net | 6,436 | 2,858 | ||||||
General and administrative expenses | 2,394 | 1,797 | ||||||
Operating loss | 8,830 | 4,655 | ||||||
Financial expenses (income), net | 5 | (395 | ) | |||||
Net Loss | 8,835 | 4,260 | ||||||
Basic and diluted loss per share of Common Stock | 0.38 | 2.69 | ||||||
Weighted average number of shares of Common Stock outstanding, basic and diluted | 23,150,253 | 2,035,625 |
R&D expenses, net (net of grants received from the Israel Innovation Authority (“IIA”) and consideration from research collaborations) were $6.4 million for the three months ended September 30, 2020, compared to $2.9 million for the three months ended September 30, 2019. The increase of $3.5 million, or 121%, is primarily due to growth in the number of employees which resulted in an increase of salaries and related expenses and due to an increase in depreciation and amortization expenses. The Company did not receive grants from the IIA during the three months ended September 30, 2020 or September 30, 2019.
General and administrative expenses were $2.4 million for the three months ended September 30, 2020, compared to $1.8 million for the three months ended September 30, 2019. The increase of $0.6 million, or 33%, is primarily due to expenses associated with operating as a public company, such as directors’ and officers’ insurance, filing and legal and accounting expenses.
Financial expenses, net were $0.1 million for the three months ended September 30, 2020, compared to financial income, net of $0.4 million for the three months ended September 30, 2019. The increase in financial expenses, net of $0.5 million is primarily due to NIS/USD exchange rate differences and contingent consideration revaluation.
Basic and diluted loss per share of Common Stock was $0.38 for the three months ended September 30, 2020, compared to $2.69 for the three months ended September 30, 2019. The decrease of $2.31, or 86%, is primarily due to the significant increase in the number of our shares of Common Stock as compared to the number of ordinary shares of BiomX Ltd. before the Recapitalization Transaction, which does not take into account BiomX Ltd. preferred shares, partially offset by the substantial increase in net loss.
Comparison of the Nine Months Ended September 30, 2020 and 2019
The following table summarizes our consolidated results of operations for the nine months ended September 30, 2020 and 2019:
Nine Months ended September 30, | ||||||||
2020 | 2019 | |||||||
USD in thousands | ||||||||
Research and development expenses, net | 14,441 | 8,458 | ||||||
General and administrative expenses | 6,749 | 3,987 | ||||||
Operating loss | 21,190 | 12,445 | ||||||
Financial income, net | (248 | ) | (1,182 | ) | ||||
Net Loss | 20,942 | 11,263 | ||||||
Basic and diluted loss per share of Common Stock | 0.91 | 7.37 | ||||||
Weighted average number of shares of Common Stock outstanding, basic and diluted | 23,013,790 | 2,015,349 |
R&D expenses, net (net of grants received from IIA and consideration from research collaborations) were $14.4 million for the nine months ended September 30, 2020, compared to $8.4 million for the nine months ended September 30, 2019. The increase of $6.0 million, or 71%, is primarily due to growth in the number of employees which resulted in an increase of salaries and related expenses. In addition, the increase is also due to the manufacturing of BX001 and BX002, the Company’s product candidates for acne-prone skin and IBD, respectively, for clinical trial and testing purposes as well as expenses relating to the BX001 Phase 1 cosmetic clinical study. We received $0.5 million and $0.3 million in grants from the IIA during the nine months ended September 30, 2020 and 2019, respectively.
General and administrative expenses were $6.7 million for the nine months ended September 30, 2020, compared to $4.0 million for the nine months ended September 30, 2019. The increase of $2.7 million, or 68%, is primarily due to salaries and related expenses and due to expenses associated with operating as a public company, such as directors’ and officers’ insurance, filing and legal and accounting expenses.
Financial income, net was $0.3 million for the nine months ended September 30, 2020, compared to $1.2 million for the nine months ended September 30, 2019. The decrease of $0.9 million, or 75%, is primarily due to NIS/USD exchange rate differences.
Basic and diluted loss per share of Common Stock was $0.91 for the nine months ended September 30, 2020, compared to $7.37 for the nine months ended September 30, 2019. The decrease of $6.46, or 88%, is primarily due to the significant increase in the number of our shares of Common Stock as compared to the number of ordinary shares of BiomX Ltd. before the Recapitalization Transaction, which does not take into account BiomX Ltd. preferred shares, partially offset by the substantial increase in net loss.
Liquidity and Capital Resources
Cash Flows
The following table summarizes our sources and uses of cash for the nine months ended September 30, 2020 and 2019:
Nine Months Ended September 30, | ||||||||
2020 | 2019 | |||||||
USD in thousands | ||||||||
Net cash used in operating activities | (17,325 | ) | (10,503 | ) | ||||
Net cash provided by (used in) investing activities | (1,049 | ) | 11,631 | |||||
Net cash provided by financing activities | 121 | 1,843 | ||||||
Net increase (decrease) in cash and cash equivalents | (18,253 | ) | 2,971 |
Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2020 was $17.3 million and included our net loss of $20.9 million, mostly due to our R&D and general and administrative expenses. Net changes in our operating activities for the nine months ended September 30, 2020 consisted primarily of depreciation and amortization in the amount of $1.6 million and share-based compensation in the amount of $2.1 million, partially offset by a decrease in accounts payable in the amount of $1.9 million.
Net cash used in operating activities for the nine months ended September 30, 2019 was $10.5 million. Net changes in our operating assets and liabilities for the nine months ended September 30, 2019 consisted primarily of $11.3 million net loss, mostly due to our R&D and general and administrative expenses, partially offset by $0.9 million in share-based compensation.
Investing Activities
During the nine months ended September 30, 2020, net cash used in investing activities was $1.0 million, mainly as a result of an increase in bank deposits and purchases of property and equipment.
During the nine months ended September 30, 2019, net cash provided by investing activities was $11.7 million, mainly as a result of a decrease in short-term bank deposits.
We have invested, and plan to continue to invest, our existing cash in short-term investments in accordance with our investment policy. These investments may include money market funds and investment securities consisting of U.S. Treasury notes, and high quality, marketable debt instruments of corporations and government sponsored enterprises. We use foreign exchange contracts (mainly option and forward contracts) to hedge balance sheet items from currency exposure. These foreign exchange contracts are not designated as hedging instruments for accounting purposes. In connection with these foreign exchange contracts, we recognize gains or losses that offset the revaluation of the balance sheet items also recorded under financial expenses, net. As of September 30, 2020, we had outstanding foreign exchange contracts in the amount of approximately $3.5 million. As of September 30, 2019, we had no outstanding foreign exchange contracts.
Financing Activities
During the nine months ended September 30, 2020 net cash provided by financing activities was $0.1 million, mainly as a result of exercise of stock options of $0.2 million, partially offset by outflows in connection with the Recapitalization Transaction of $0.1 million.
During the nine months ended September 30, 2019, net cash provided by financing activities was $1.8 million, as a result of the issuance of preferred shares, net of expenses.
Outlook
We have accumulated a deficit of $63.1 million since our inception. To date, we have not generated revenue from our operations and we do not expect to generate any significant revenues from sales of products in the next twelve months. Our cash needs may increase in the foreseeable future. We expect to generate revenues, from the sale of licenses to use our technology or products, but in the short and medium terms any amounts generated are unlikely to exceed our costs of operations. According to our estimates, our liquidity resources as of September 30, 2020, which consisted primarily of cash, cash equivalents and restricted cash of approximately $54 million and short-term deposits of approximately $10 million, will be sufficient to fund our operations into at least the second quarter of fiscal year 2022.
Consistent with our continuing R&D activities, we expect to continue to incur additional losses in the foreseeable future. To the extent we require funds above our existing liquidity resources in the medium and long term, we plan to fund our operations, as well as other development activities relating to additional product candidates, through future issuances of equity securities, debt and possibly additional grants from the Israel Innovation Authority or other government or non-profit institutions. Our ability to raise additional capital in the equity and debt markets is dependent on a number of factors including, but not limited to, the market demand for our securities, which itself is subject to a number of development and business risks and uncertainties, as well as the uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable to the Company.
Off-Balance Sheet Arrangements
As of September 30, 2020, we did not have any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Critical Accounting Policies and Significant Judgments and Estimates
Our condensed consolidated financial statements are prepared in accordance with GAAP. The preparation of our condensed consolidated financial statements and related disclosures requires us to make assumptions, judgments and estimates that can have a significant impact on our revenue, operating income and net income, as well as on the value of certain assets and liabilities on our condensed consolidated balance sheets. We base our assumptions, judgments and estimates on historical experience and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not historical facts,readily apparent from other sources. We evaluate our estimates and involve risksassumptions on an ongoing basis.
Due to the COVID-19 pandemic, there has been uncertainty and uncertaintiesdisruption in the global economy and financial markets. We are not aware of any specific event or circumstance that could cause actualwould require updates to our estimates or judgments or require us to revise the carrying value of our assets or liabilities as of November 9, 2020, the date of issuance of this Quarterly Report on Form 10-Q. These estimates may change as new events occur and additional information is obtained. Actual results tocould differ materially from those expected and projected. All statements, other than statements of historical fact included in this Quarterly Report including, without limitation, statements in this “Management’sthese estimates under different assumptions or conditions.
Our actual results may differ from these estimates under different assumptions or conditions. Part II, Item 7—“Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding the Company’s financial position, business strategy and the plans and objectives of management for future operations, are forward-looking statements. Words such as “expect,” “believe,” “anticipate,” “intend,” “estimate,” “seek” and variations and similar words and expressions are intended to identify such forward-looking statements. Such forward-looking statements relate to future events or future performance, but reflect management’s current beliefs, based on information currently available. A number of factors could cause actual events, performance or results to differ materially from the events, performance and results discussed in the forward-looking statements. For information identifying important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to the Risk Factors sectionour 2019 Annual Report includes a summary of the Company’s final prospectus for its Initial Public Offering filed with the SEC. The Company’s securities filings can be accessed on the EDGAR section of the SEC’s website at www.sec.gov. Except as expressly required by applicable securities law, the Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Overview
We are a blank check company formed under the laws of the State of Delaware on November 1, 2017 for the purpose of effecting a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization or similar business combination with one or more businesses. We intend to effectuate our Business Combination using cash from the proceeds of Initial Public Offering and the sale of the Private Placement Warrants, our securities, debt or a combination of cash, securities and debt. Our efforts to identify a prospective target business will not be limited to a particular geographic region or industry, although we intend to focus on North America in the healthcare industry.
Our acquisition strategy is to identify, acquire and build a public company. Our selection process will leverage our team’s network of industry, venture capital, hedge fund, private equity and lending community relationships as well as relationships with management teams of public and private companies, investment bankers, attorneys and accountants, whichcritical accounting policies we believe should provide us with a number of business combination opportunities. We intendare the most important to deploy a proactive, thematic sourcing strategy and to focus on companies where we believe the combination of the relationships, capital, capital markets expertise and operating experience ofaid in understanding our team, can help accelerate the target business’ growth and performance. We will initially focus on emerging growth healthcare companies in healthcare niches including, but not limited to, biotechnology, medical technology and digital health.
Results of Operations
We have neither engaged in any operations nor generated any revenues to date. Our only activities from inception to December 31, 2018 were organizational activities and those necessary to prepare for the Initial Public Offering, described below, and, after our Initial Public Offering, identifying a target company for a Business Combination. We do not expect to generate any operating revenues until after the completion of our Business Combination. We expect to generate non-operating income in the form of interest income on marketable securities held in the Trust Account. We expect that we will incur increased expenses as a result of being a public company (for legal, financial reporting, accounting and auditing compliance), as well as for due diligence expenses.
For the three and six months ended December 31, 2018, we had net income of $10,458 and $9,808, respectively, which consists of interest income on marketable securities held in the Trust Account of $55,546, offset by an unrealized loss on marketable securities held in our Trust Account of $21,087, operating costs of $15,789 and $16,439, respectively, and a provision for income taxes of $8,212.
Liquidity and Capital Resources
On December 18, 2018, we consummated the Initial Public Offering of 7,000,000 Units, at $10.00 per Unit, generating gross proceeds of $70,000,000. Simultaneously with the closing of the Initial Public Offering, we consummated the sale of 2,900,000 Private Placement Warrants, at $0.40 per Private Placement Warrant, to Mountain Wood, LLC, an affiliate of Chardan Investments, LLC (the “Sponsor”), generating gross proceeds of $1,160,000.
As of December 31, 2018, we had marketable securities held in the Trust Account of $70,034,459 (including approximately $34,000 of interest income, net of unrealized losses) consisting of U.S. Treasury Bills with a maturity of 180 days or less. Interest income on the balance in the Trust Account may be used by us to pay taxes. Through December 31, 2018, we did not withdraw any interest earned on the Trust Account.
For the six months ended December 31, 2018, cash used in operating activities was $75,939. Net income of $9,808 was affected by interest earned on marketable securities held in the Trust Account of $55,546, an unrealized loss on marketable securities held in our Trust Account of $21,087 and changes in operating assets and liabilities, which used $51,288 of cash.
We intend to use substantially all of the funds held in the Trust Account, including any amounts representing interest earned on the Trust Account (which interest shall be net of amounts withdrawn to pay our taxes) to complete a Business Combination. To the extent that our capital stock or debt is used, in whole or in part, as consideration to complete a Business Combination, the remaining proceeds held in the Trust Account will be used as working capital to finance the operations of the target business.
As of December 31, 2018, we had cash of $846,840 held outside the Trust Account. We intend to use the funds held outside the Trust Account primarily to identify and evaluate prospective acquisition candidates, perform business due diligence on prospective target businesses, travel to and from the offices, plants or similar locations of prospective target businesses, review corporate documents and material agreements of prospective target businesses, select the target business to acquire and structure, negotiate and complete a Business Combination.
In order to fund working capital deficiencies or finance transaction costs in connection with a Business Combination, our initial stockholders, officers and directors or their affiliates may, but are not obligated to, loan us funds from time to time or at any time, as may be required. If we complete a Business Combination, we would repay such loaned amounts out of the proceeds of the Trust Account released to us. In the event that a Business Combination does not close, we may use a portion of the working capital held outside the Trust Account to repay such loaned amounts, but no proceeds from our Trust Account would be used to repay such loaned amounts. Up to $500,000 of such loans may be convertible into private warrants at a price of $0.40 per private warrant at the option of the lender. The private warrants would be identical to the Private Placement Warrants.
We do not believe we will need to raise additional funds in order to meet the expenditures required for operating our business. However, if our estimate of the costs of identifying a target business, undertaking in-depth due diligence and negotiating a Business Combination are less than the actual amounts necessary to do so, we may have insufficient funds available to operate our business prior to our Business Combination. Moreover, we may need to obtain additional financing either to complete our Business Combination or because we become obligated to redeem a significant number of our public shares upon completion of our Business Combination, in which case we may issue additional securities or incur debt in connection with such Business Combination. Subject to compliance with applicable securities laws, we would only complete such financing simultaneously with the completion of our Business Combination. If we are unable to complete our Business Combination because we do not have sufficient funds available to us, we will be forced to cease operations and liquidate the Trust Account. In addition, following our Business Combination, if cash on hand is insufficient, we may need to obtain additional financing in order to meet our obligations.
Off-Balance Sheet Arrangements
We have no obligations, assets or liabilities, which would be considered off-balance sheet arrangements as of December 31, 2018. We do not participate in transactions that create relationships with unconsolidated entities or financial partnerships, often referred to as variable interest entities, which wouldresults. There have been established for the purpose of facilitating off-balance sheet arrangements. Weno changes to those critical accounting policies that have not entered into any off-balance sheet financing arrangements, established any special purpose entities, guaranteed any debt or commitments of other entities, or purchased any non-financial assets.
Contractual obligations
We do not have any long-term debt, capital lease obligations, operating lease obligations or long-term liabilities.
Critical Accounting Policies
The preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect thehad a material impact on our reported amounts of assets, liabilities, revenue, costs and liabilities,expenses, or the disclosure of contingent assets and liabilities at the date of thein our condensed consolidated financial statements and income and expenses during the periods reported. Actual results could materially differ from those estimates. We have identified the following critical accounting policy. nine months ended September 30, 2020.
Common stock subject to possible redemption
We account for common stock subject to possible redemption in accordance with the guidance in Accounting Standards Codification (“ASC”) Topic 480 “Distinguishing Liabilities from Equity.” Common stock subject to mandatory redemption is classified as a liability instrument and is measured at fair value. Conditionally redeemable common stock (including common stock that features redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) is classified as temporary equity. At all other times, common stock is classified as stockholders’ equity. Our common stock features certain redemption rights that are considered to be outside of our control and subject to occurrence of uncertain future events. Accordingly, at December 31, 2018, common stock subject to possible redemption is presented at redemption value as temporary equity, outside of the stockholders’ equity section of our balance sheet.
Recent accounting standards
Management does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on our condensed financial statements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Following the consummation of our Initial Public Offering,As a smaller reporting company, we invested the funds held in the Trust Account in money market funds meeting certain conditionsare not required to make disclosures under Rule 2a-7 under the Investment Company Act, which invest solely in United States Treasuries. Due to the short-term nature of the money market fund’s investments, we do not believe that there will be an associated material exposure to interest rate risk.this Item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our principal executive officer and principal financial and accounting officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of the end of the fiscal quarter ended December 31, 2018, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation, our principal executive officer and principal financial and accounting officer have concluded that during the period covered by this report, our disclosure controls and procedures were effective.
Disclosure controls and procedures are designed to ensure that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures during the period covered by this Quarterly Report, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures were effective as of September 30, 2020.
Changes in Internal Control Overover Financial Reporting
During the fiscal quarter covered by this Current Report on Form 10-Q,Except as described below, there hashave been no changechanges in our internal control over financial reporting that hasoccurred during the fiscal quarter to which this report relates that have materially affected, or isare reasonably likely to materially affect, our internal control over financial reporting.
Following the Recapitalization Transaction, management has begun to take steps to strengthen the Company’s internal control over financial reporting, including during the quarter ended September 30, 2020, including the hiring of experienced accounting and finance staff and adopting new policies and procedures, and intends to take additional steps during the remainder of 2020.
None.
Factors that could cause our actual resultsIn addition to differ materially from thosethe other information set forth in this Quarterly Report are any ofreport, you should carefully consider the risks describedfactors discussed in Part I, “Item 1A. Risk Factors” in our final prospectusAnnual Report on Form 10-K for the year ended December 31, 2019, which could materially affect our Initial Public Offeringbusiness, financial condition or future results.
There have been no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the SEC on March 26, 2020, except as noted below.
The COVID-19 pandemic may adversely affect our business, including our clinical trials.
In December 14, 2018. Any2019, a novel strain of these factors could resultcoronavirus, COVID-19, was identified in Wuhan, China. This virus was declared a pandemic by the World Health Organization in March 2020 and continues to spread globally, including the United States and Israel. The outbreak and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen. In response to the spread of COVID-19, we temporarily closed our executive offices with our administrative employees continuing their work outside of our offices. In addition, we have modified our business practices, including restricting employee travel, developing social distancing plans for our employees and cancelling physical participation in meetings, events and conferences. As a result of the COVID-19 pandemic, we have experienced and may continue to experience additional disruptions that could severely impact our business, preclinical studies and clinical trials, including:
● | delays or difficulties in enrolling patients in our clinical trials; |
● | delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; |
● | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; |
● | interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, in the U.S. and the government in Israel, employers and others or interruption of clinical trial subject visits and study procedures (such as endoscopies that are deemed non-essential), which may impact the integrity of subject data and clinical study endpoints; |
● | interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines; |
● | interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems; |
● | limitations on employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; and |
● | interruptions or delays to our sourced discovery and clinical activities. |
The outbreak and the resulting government actions may adversely impact our planned and ongoing clinical trials. Clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff, and patient enrollment may be delayed due to prioritization of hospital resources toward the COVID-19 pandemic. Some patients may not be willing and/or able to comply with clinical trial protocols due to the COVID-19 pandemic, particularly if quarantines impede patient movement or interrupt healthcare services. Similarly, our ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 may be impeded, which would adversely impact our clinical trial operations. The diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, including the attention of physicians serving as our clinical trial investigators and hospitals serving as our clinical trial sites, may significantly disrupt our research activities. As a result, the expected timeline for data readouts of our clinical trials and certain regulatory filings will likely be negatively impacted, which would adversely affect and delay our ability to obtain regulatory approvals for our product candidates, increase our operating expenses and have a material adverse effect on our resultsfinancial condition.
Furthermore, the response to the COVID-19 pandemic may redirect resources with respect to regulatory matters and intellectual property matters in a way that would adversely impact our ability to progress regulatory approvals and protect our intellectual property. In addition, we may face impediments to regulatory meetings and approvals due to measures intended to limit in-person interactions. For example, the FDA postponed most inspections of operationsforeign manufacturing facilities and products and postponed routine surveillance inspections of domestic manufacturing facilities. Comparable regulatory authorities in other jurisdictions may adopt similar restrictions or financial condition. Additional risk factors not presently knownother policy measures in response to usthe COVID-19 pandemic and provide guidance regarding the conduct of clinical trials. If global health concerns continue to prevent the FDA or that we currently deem immaterial may also impair our businessother regulatory authorities from conducting their regular inspections, reviews or results of operations. Asother regulatory activities, it could significantly impact the ability of the date of this Quarterly Report, thereFDA to timely review and process our regulatory submissions, which could have been noa material changes to the risk factors disclosed inadverse effect on our final prospectus dated December 14, 2018 filed with the SEC.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
In March 2018, our Sponsor purchased 1,437,500 shares (the “Founder Shares”) of the Company’s common stock for an aggregate price of $25,000. On September 14, 2018, the Company effected stock dividends of 1.4-for-1 share of common stock, for each outstanding share of common stock, resulting in 2,012,500 Founder Shares outstanding. The underwriters’ over-allotment option expired unexercised on February 4, 2019. As a result, The foregoing issuance was made pursuant to the exemption from registration contained in Section 4(a)(2) of the Securities Act of 1933, as amended (“Securities Act”).
On December 18, 2018, we consummated the Initial Public Offering of 7,000,000 Units. The Units sold in the Initial Public Offering were sold at an offering price of $10.00 per Unit, generating total gross proceeds of $70,000,000. Chardan Capital Markets LLC. acted as sole book-running manager of the Initial Public Offering. The securities in the offering were registered under the Securities Act on a registration statement on Form S-1 (No. 333-228533). The SEC declared the registration statement effective on December 13, 2018. We granted the underwriters a 45-day option to purchase up to 1,050,000 additional Units to cover over-allotments at the Initial Public Offering price, less the underwriting discounts and commissions. The over-allotment option expired unexercised on February 4, 2019.
Simultaneous with the consummation of the Initial Public Offering, we consummated the private placement of an aggregate of 2,900,000 warrants, each exercisable to purchase one share of the Company’s common stock for $11.50 per share (“Private Placement Warrants”), to Mountain Wood, LLC, an affiliate of the Sponsor at a price of $0.40 per Private Placement Warrant, generating total proceeds of $1,160,000. The issuance was made pursuant to the exemption from registration contained in Section 4(a)(2) of the Securities Act.business.
The Private Placement WarrantsCOVID-19 pandemic continues to rapidly evolve. The extent to which the outbreak impacts our business, preclinical studies and clinical trials will depend on future developments, which are identical tohighly uncertain and cannot be predicted with confidence, such as the warrants underlyingultimate geographic spread of the Units solddisease, the duration of the pandemic, travel restrictions and social distancing in the Initial Public Offering, except that the Private Placement Warrants are not transferable, assignableUnited States Canada, Europe, Israel and other countries, business closures or salable until after the completion of a Business Combination, subject to certain limited exceptions. Additionally, the Private Warrants are exercisable on a cashless basis and are non-redeemable so long as they are held by the initial purchasers or their permitted transferees.
Of the gross proceeds received from the Initial Public Offeringbusiness disruptions and the Private Placement Warrants, $70,000,000 was placedeffectiveness of actions taken in the United States, Canada, Europe, Israel and other countries to contain and treat the disease. As a Trust Account. We paidresult, the COVID-19 pandemic could have a totalmaterial adverse effect on our business, results of $500,000operations, financial condition and prospects and heighten many of our known risks described or referenced in underwriting discounts and commissions and $283,566 for other costs and expenses related to the Initial Public Offering.
For a description of the use of the proceeds generated in our Initial Public Offering, see Part I, Item 2 of this Form 10-Q.
Item 3. Defaults Upon Senior Securities.
None
Item 4. Mine Safety Disclosures.
Not Applicable.
None.“Risk Factors” section.
The following exhibits are filed as part of, or incorporated by reference into, this Quarterly Report on Form 10-Q.
* | Filed herewith. |
* Filed herewith.
** | Furnished herewith. |
(1) Previously filed as an exhibit to our Current Report on Form 8-K filed on December 19, 2018 and incorporated by reference herein
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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.
Date: | By: | /s/ |
Name: | ||
Title: | ||
(Principal Executive Officer) | ||
Date: | By: | /s/ |
Name: | ||
Title: | ||
(Principal Financial Officer and Principal Accounting Officer) |
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