Peak Bio, Inc. - Quarter Report: 2023 June (Form 10-Q)

10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2023


☐	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: 001-39951

Peak Bio, Inc.

(Exact Name of Registrant as Specified in its Charter)


Delaware	85-2448157
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
4900 Hopyard Road., Suite 100 Pleasanton, CA	94588
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (925) 463-4800

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

PKBO

OTC Pink

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically 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, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 18, 2023, the registrant had 21,903,843 shares of common stock, $0.0001 par value per share, outstanding.

Table of Contents


		Page

PART I.	FINANCIAL INFORMATION

Item 1.	Condensed Consolidated Financial Statements (Unaudited)	3
	Condensed Consolidated Balance Sheets	3
	Condensed Consolidated Statements of Operations and Comprehensive Loss	4
	Condensed Consolidated Statements of Deficit	5
	Condensed Consolidated Statements of Cash Flows	6
	Notes to Unaudited Condensed Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	25
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	34
Item 4.	Controls and Procedures	34

PART II.	OTHER INFORMATION

Item 1.	Legal Proceedings	35
Item 1A.	Risk Factors	35
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	36
Item 3.	Defaults Upon Senior Securities	36
Item 4.	Mine Safety Disclosures	36
Item 5.	Other Information	36
Item 6.	Exhibits	36
Signatures		36

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

PEAK BIO, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS


	June 30, 2023			December 31, 2022
	(Unaudited)
Assets
Current assets
Cash and cash equivalents	$	214,369		$	654,892
Derivative asset		—			13,000
Prepaid expenses and other current assets		1,299,423			2,562,901
Total current assets		1,513,792			3,230,793
Property and equipment, net		219,915			376,648
Restricted cash		60,000			239,699
Operating lease right-of-use asset		—			3,681,072
Noncurrent assets		1,500			1,500
Total assets	$	1,795,207		$	7,529,712
Liabilities and deficit
Current liabilities
Accounts payable	$	5,128,097		$	3,618,026
Accrued expenses		2,603,518			2,038,291
Operating lease liability, current		4,254,579			720,577
Insurance financing payable		230,394			921,576
Derivative liability		1,562,379			166,000
Convertible note payable		2,242,807			1,374,698
Convertible note payable, related party		1,089,903			—
Related party loan		901,370			1,961,953
Total current liabilities		18,013,047			10,801,121
Operating lease liability, net of current portion		—			3,507,268
Warrant liability		2,870,757			525,000
Other noncurrent liabilities		230,650			790,800
Total liabilities		21,114,454			15,624,189
Commitments and contingencies (Note 9)
Equity (deficit)
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; none issued and outstanding		—			—
Common stock, par value of $0.0001 per share; 60,000,000 shares authorized; 20,862,177 shares issued and outstanding as of June 30, 2023, and 21,713,248 shares issued and 19,782,747 shares outstanding as of December 31, 2022, respectively.		2,086			1,978
Additional paid-in capital		18,623,833			17,219,593
Accumulated net parent investment in Peak Bio		—			—
Accumulated deficit		(38,056,626	)		(25,345,566	)
Accumulated other comprehensive income		111,460			29,518
Total deficit		(19,319,247	)		(8,094,477	)
Total liabilities and deficit	$	1,795,207		$	7,529,712

See accompanying notes to the condensed consolidated financial statements.

PEAK BIO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)


	For the three months ended June 30,						For the six months ended June 30,
	2023			2022			2023			2022
Revenue
Grant revenue	$	—		$	100,916		$	13,854		$	153,866
Total revenue		—			100,916			13,854			153,866
Operating expenses
Research and development		371,154			1,168,564			1,084,260			2,574,737
General and administrative		2,299,058			1,560,182			5,303,880			2,533,008
Impairment loss on operating lease right-of-use asset		—			—			3,513,999			—
Total operating expenses		2,670,212			2,728,746			9,902,139			5,107,745
Loss from operations		(2,670,212	)		(2,627,830	)		(9,888,285	)		(4,953,879	)
Other (expense) income
Interest income		20			564			26			2,102
Interest expense		(998,548	)		—			(1,059,934	)		(4,005	)
Fair value adjustment to warrant liability		(712,857	)		—			(187,857	)		—
Fair value adjustment to derivative		(548,233	)		—			(560,233	)		—
Other (expense) income		(29	)		98,608			(409	)		323,189
Loss on extinguishment of debt		(1,014,368	)		—			(1,014,368	)		—
Total other (expense) income, net		(3,274,015	)		99,172			(2,822,775	)		321,286
Loss before income tax expense		(5,944,227	)		(2,528,658	)		(12,711,060	)		(4,632,593	)
Income tax benefit		—			5,800			—			9,300
Net loss	$	(5,944,227	)	$	(2,522,858	)	$	(12,711,060	)	$	(4,623,293	)
Other comprehensive loss:
Foreign currency translation		10,366			(39,046	)		81,942			(64,586	)
Total comprehensive loss	$	(5,933,861	)	$	(2,561,904	)	$	(12,629,118	)	$	(4,687,879	)
Basic and diluted weighted average shares outstanding		20,254,118			17,162,742			20,047,100			17,199,290
Basic and diluted net loss per share	$	(0.29	)	$	(0.15	)	$	(0.63	)	$	(0.27	)

See accompanying notes to the condensed consolidated financial statements.

PEAK BIO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT

(Unaudited)


	Common Stock
	Shares		Amount		Additional Paid-In Capital		Accumulated Other Comprehensive Income (Loss)			Accumulated Deficit			Total Stockholders' Deficit
Balance, December 31, 2021		17,162,742	$	1,716	$	6,428,837	$	88,443		$	(8,454,264	)	$	(1,935,268	)
Capital contribution from parent		—		—		1,363,974		—			—			1,363,974
Foreign currency translation		—		—		—		(25,540	)		—			(25,540	)
Net loss		—		—		—		—			(2,100,435	)		(2,100,435	)
Balance, March 31, 2022		17,162,742	$	1,716	$	7,792,811	$	62,903		$	(10,554,699	)	$	(2,697,269	)
Issuance of common stock		132,302		13		1,152,150		—			—			1,152,163
Foreign currency translation		—		—		—		(39,046	)		—			(39,046	)
Share-based compensation		—		—		165,777		—			—			165,777
Net loss		—		—		—		—			(2,522,858	)		(2,522,858	)
Balance, June 30, 2022		17,295,044	$	1,729	$	9,110,738	$	23,857		$	(13,077,557	)	$	(3,941,233	)

Balance, December 31, 2022		19,782,747	$	1,978	$	17,219,593	$	29,518		$	(25,345,566	)	$	(8,094,477	)
Issuance of common stock		412,763		41		249,959		—			—			250,000
Share-based compensation		—		—		165,007		—			—			165,007
Foreign currency translation		—		—		—		71,576			—			71,576
Net loss		—		—		—		—			(6,766,833	)		(6,766,833	)
Balance, March 31, 2023		20,195,510	$	2,019	$	17,634,559	$	101,094		$	(32,112,399	)	$	(14,374,727	)
Issuance of common stock upon exercise of warrants		666,667		67		644,194		—			—			644,261
Extinguishment of related party debt		—		—		211,643		—			—			211,643
Share-based compensation		—		—		133,437		—			—			133,437
Foreign currency translation		—		—		—		10,366			—			10,366
Net loss		—		—		—		—			(5,944,227	)		(5,944,227	)
Balance, June 30, 2023		20,862,177	$	2,086	$	18,623,833	$	111,460		$	(38,056,626	)	$	(19,319,247	)

See accompanying notes to the condensed consolidated financial statements.

PEAK BIO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)


	For the six months ended June 30,
	2023			2022
Cash flows from operating activities
Net loss	$	(12,711,060	)	$	(4,623,293	)
Adjustment to reconcile net loss to net cash used in operating activities
Share-based compensation		298,444			273,791
Depreciation		77,238			80,576
Impairment loss on operating lease right-of-use asset		3,513,999			—
Loss on disposal of equipment		79,495			—
Change in fair value of warrant liability		187,857			—
Change in fair value of derivative liability		560,233			—
Loss on extinguishment of debt		1,014,368			—
Issuance of shares for financing fee		250,000			—
Amortization of right-of-use lease asset		167,073			420,864
Accretion of convertible notes payable		994,944			—
Changes in operating assets and liabilities
Prepaid expenses and other current assets		1,262,146			(182,687	)
Deferred offering costs		—			(470,772	)
Accounts payable		1,517,293			1,613,112
Accrued expenses and other current liabilities		647,879			672,958
Operating lease liability		26,734			103,747
Other noncurrent liabilities		(560,150	)		(184,959	)
Net cash used in operating activities		(2,673,507	)		(2,296,663	)
Cash flows from investing activities
Purchase of property and equipment		—			(122,450	)
Net cash used in investing activities		—			(122,450	)
Cash flows from financing activities
Proceeds from issuance of common shares		400,000			1,152,163
Proceeds from convertible notes payable		2,195,034			—
Payment of debt issuance costs		(125,803	)		—
Proceeds from net shareholder contributions		—			1,250,578
Repayment of insurance financing payable		(691,182	)		—
Proceeds from related party loan		250,000			23,044
Net cash provided by financing activities		2,028,049			2,425,785
Net (decrease) increase in cash and cash equivalents		(645,458	)		6,672
Effect of exchange rate changes on cash and cash equivalents		25,236			(64,586	)
Cash and cash equivalents, beginning of year		894,591			442,477
Cash and cash equivalents, end of year	$	274,369		$	384,563
Components of cash, cash equivalents and restricted cash
Cash and cash equivalents		214,369			147,563
Restricted cash		60,000			237,000
Total cash, cash equivalents and restricted cash		274,369			384,563
Non-cash investing and financing activities:
Exchange of related party loans for convertible notes, related party	$	1,130,775		$	—
Fair value of warrants issued with convertible notes, related party	$	786,967		$	—
Fair value of warrants issued with convertible notes	$	1,615,194		$	—
Fair value of derivative issued with convertible notes	$	849,146
Operating lease liabilities arising from obtaining right-of-use assets	$	—		$	4,189,492
Related party loan entered into for settlement of accrued expenses	$	—		$	400,000

See accompanying notes to the condensed consolidated financial statements.

PEAK BIO, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

Description of the Business

Peak Bio, Inc., together with its consolidated subsidiaries (the “Company” or “Peak Bio”), is a clinical-stage biotechnology company focused on discovering, developing and delivering innovative therapies for multiple therapeutic areas. The Company has established a portfolio of potential therapies for the aging population. The Company’s pipeline includes the PHP-303 program for genetic disease, liver disease and inflammation, specifically for Alpha-1 antitrypsin deficiency (AATD) and acute respiratory distress syndrome (ARDS) including COVID-19. The Company’s pipeline also includes PH-1 ADC Platform for oncology.

The accompanying condensed consolidated financial statements and notes have been prepared to include certain assets and liabilities of pH Pharma Co., Ltd (now Peak Bio Co., Ltd. or “Peak Bio”) (sometimes referred to as “pH Pharma Ltd” prior to the Spin-Off described below), on the basis described within Note 2, with certain wholly-owned subsidiaries of Peak Bio, that were included following the Spin-Off as follows: Ph Pharma, Inc, as well as certain assets and liabilities allocated to Peak Bio, including the PHP- 303 and PH-1 ADC Platform programs.

The spin-off (the “Spin-Off”) of certain assets of pH Pharma Co., Ltd. was completed on March 1, 2022, prior to the execution of the Business Combination Agreement (as defined below) with Ignyte Acquisition Corp. (“Ignyte”), with Peak Bio retaining the PHP-303 and PH-1 ADC Platform programs. Historically and throughout the periods presented, the PHP-303 and PH-1 ADC Platform programs have been owned by pH Pharma Co., Ltd and its subsidiaries (prior to the change of its name to Peak Bio Co., Ltd.).

As of June 30, 2023, the Company’s wholly owned subsidiary was Peak Bio Co., Ltd., organized under the laws of the Republic of Korea, and its subsidiary Peak Bio CA, Inc., organized under the laws of California.

Business Combination

On November 1, 2022 (the “Closing Date”), the Company completed the transactions contemplated by that certain business combination agreement, dated as of April 28, 2022 (the “Business Combination Agreement”), by and among Ignyte Acquisition Corp. (“Ignyte”), Ignyte Korea Co., Ltd., a corporation organized under the laws of the Republic of Korea (“Korean Sub”), and Peak Bio Co., Ltd. At the closing of the transactions, (i) the stockholders of Peak Bio Co., Ltd. transferred their respective shares of common stock to Korean Sub in exchange for shares of Ignyte common stock held by Korean Sub, and (ii) in the course of such share swap, Korean Sub distributed the shares of Peak Bio Co., Ltd. common stock to Ignyte in consideration of Ignyte common stock (which was in-turn delivered to the stockholders of Peak Bio Co., Ltd. as described in (i) above ((i) and (ii), collectively, the “Share Swap”). Upon consummation of the Share Swap, Peak Bio Co., Ltd. became a direct wholly-owned subsidiary of Ignyte. The transactions contemplated by the Business Combination Agreement are referred to herein as the “Business Combination.” Upon the closing of the Business Combination, Ignyte as the registrant changed its name to “Peak Bio, Inc.”

Risks and Uncertainties

The Company relies, and expects to continue to rely, on a small number of vendors to provide services, supplies and materials related to its research and development programs. These research and development programs could be adversely affected by a significant interruption in these services or the availability of materials.

Going Concern

Since inception, the Company has incurred significant net losses. The Company incurred net losses of $12.7 million and $4.6 million for the six months ended June 30, 2023 and 2022, respectively, and $13.1 million and $8.3 million for the years ended December 31, 2022 and 2021, respectively. The Company had not initially been capitalized with sufficient funding to conduct its operations. Since the Company had no available cash or credit facilities, the Company was dependent upon Peak Bio Co., Ltd. (formerly pH Pharma Ltd) and its affiliates to provide services and funding to support the operations of the Company through the closing of the Business Combination. The Company expects to incur significant expenses and operating losses for the foreseeable future as it continues its efforts to identify product candidates and seek regulatory approvals within its portfolio.

The Company will need additional financing to fund its ongoing activities. The Company may raise this additional funding through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions and funding under government contracts. The Company may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms, or at all. If the Company is unable to raise capital when needed or on attractive terms, the Company could be forced to delay, reduce or eliminate certain of the Company’s research and development programs. There can be no assurances that other sources of financing would be available. Due to these uncertainties, there is substantial doubt about the Company’s ability to continue as a going concern.

The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or classification of liabilities that might result from the outcome of the uncertainties discussed above.

The Company’s future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of additional financing as discussed above; (ii) the success of its research and development programs; (iii) the development of competitive therapies by other biotechnology and pharmaceutical companies; (iv) the Company’s ability to manage growth of the organization; (v) the Company’s ability to protect its proprietary technology; and ultimately (vi) regulatory approval and market acceptance of the Company’s product candidates.

Summary of Significant Accounting Policies

For the six months ended June 30, 2023, there have been no changes to the significant accounting policies as disclosed in Note 2 to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “2022 Consolidated Financial Statements”).

Unaudited Financial Information

The Company’s unaudited condensed consolidated financial statements included herein have been prepared in conformity with accounting principles generally accepted in the United States of America, or GAAP, and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC. In the Company’s opinion, the information furnished reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the financial position and results of operations for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes for the year ended December 31, 2022.

Basis of Presentation

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and are comprised of the Company’s activities distributed across multiple legal entities.

Basis of Presentation Prior to April 1, 2022

These consolidated financial statements were extracted from the accounting records of pH Pharma Ltd. on a carve-out basis prior to April 1, 2022. The historical results of operations, financial position, and cash flows may not be indicative of what such results of operations, financial position, and cash flows would have been had the Company been a separate standalone entity, nor are they indicative of what the results of operations, financial position and cash flows may be in the future. The accompanying carve-out consolidated financial statements reflect assets, liabilities, revenue, and expenses that are directly attributable to the Company, including the assets, liabilities, revenue and expenses of the PHP-303 and PH-1 ADC Platform programs.

Basis of Presentation After April 1, 2022

The Spin-Off resulted in Peak Bio retaining the PHP-303 and PH-1 ADC Platform programs. Historically and

throughout the periods presented, the PHP-303 and PH-1 ADC Platform programs have been owned by pH Pharma Co., Ltd and its subsidiaries (prior to the change of its name to Peak Bio Co., Ltd.). The PHP-303 and PH-1 ADC Platform programs have historically operated as a part of pH Pharma Co., Ltd and not as a separate stand-alone entity or group. The Spin-Off resulted in Peak Bio retaining approximately 90% of the equity outstanding in pH Pharma Co., Ltd., consisting of 8,283,613 shares of common stock and 693,000 stock options, before giving effect to the exchange ratio of 2.0719.

As of April 1, 2022, as a result of the Spin-Off, the Company concluded that all the assets and liabilities of the newly created Peak Bio legal entity were contributed by the parent company pH Pharma Ltd. No other assets or liabilities were considered to be attributable to Peak Bio or that would be transferred to Peak Bio upon the completion of the Business Combination, eliminating the necessity to allocate a portion of pH Pharma Ltd.’s assets and liabilities to Peak Bio on a carve-out basis. Therefore, there was no longer a need to allocate assets and liabilities, as well as expenses, from the parent company for the consolidated financial statements.

Basis of Presentation After Consummation of Business Combination Agreement

The Business Combination was accounted for as a reverse recapitalization in accordance with U.S. GAAP (the “Reverse Recapitalization”). Under this method of accounting, Ignyte is treated as the “acquired” company and Peak Bio Co., Ltd. is treated as the acquirer for financial reporting purposes. Accordingly, for accounting purposes, the Reverse Recapitalization was treated as the equivalent of Peak Bio issuing stock for the net assets of Ignyte, accompanied by a recapitalization.

The consolidated assets, liabilities and results of operations prior to the Reverse Recapitalization are those of Peak Bio. At the closing date, and subject to the terms and conditions of the Business Combination Agreement, each share of Peak Bio's common stock, par value $0.0001 per share, was converted into common stock equal to 2.0719 (the "Exchange Ratio"). The shares and corresponding capital amounts and losses per share, prior to the Business Combination, have been retroactively restated based on shares reflecting the Exchange Ratio established in the Business Combination.

Reclassification

During the six months ended June 30, 2022, the Company reclassified interest income from interest expense resulting in an increase in interest income of $2,102 and a corresponding decrease in interest expense of $2,102. The reclassification had no impact on total operating costs, loss from operations, net loss, earnings per share or total deficit.

Use of Estimates

The preparation of unaudited condensed financial statements in conformity with US 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 of the unaudited condensed financial statements and the reported amounts of 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 unaudited condensed financial statements, which management considered in formulating its estimate, could change in the near term due to one or more future confirming events. Actual results could differ from those estimates.

Net Loss Per Share

The Company has reported losses since inception and has computed basic net loss per share attributable to common stockholders by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. The Company computes diluted net loss per common share after giving consideration to all potentially dilutive common shares, including options to purchase common stock, outstanding during the period determined using the treasury-stock and if-converted methods, except where the effect of including such securities would be antidilutive. Because the Company has reported net losses since inception, these potential common shares have been anti-dilutive and basic and diluted loss per share have been the same.

The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to include them would be anti-dilutive (in common stock equivalent shares):


	June 30,		December 31
	2023		2022
Stock options to purchase common stock		1,749,102		1,750,967
Warrants to purchase common stock		10,953,063		5,867,045

Recently Issued Accounting Standards

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets. In April 2019, the FASB issued clarification to ASU 2016-13 within ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, or ASU 2016-13. The guidance is effective for fiscal years beginning after December 15, 2022. The adoption of ASU No. 2016-13 on January 1, 2023 did not have a material effect on the Company's financial statements.

In August 2020, the FASB issued ASU 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity” (“ASU 2020-06”), which simplifies the accounting for convertible instruments by removing major separation models required under current U.S. GAAP. ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, which will permit more equity contracts to qualify for such exception and simplifies the diluted earnings per share calculation in certain areas. ASU 2020-06 is effective for public business entities that meet the definition of a SEC filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is currently assessing the potential impact of adopting ASU 2020-06 on its financial statements and financial statement disclosures.

Management does not believe that any other recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the Company’s financial statements.

Property and Equipment

Property and equipment consist of the following:


	June 30,			December 31
	2023			2022
Lab equipment	$	682,209		$	682,209
Leasehold improvements		41,578			41,578
Computer and office equipment		25,380			120,774
Computer software		3,725			3,725
Gross property and equipment	$	752,892		$	848,286
Less: accumulated depreciation		(532,977	)		(471,638	)
Net property and equipment	$	219,915		$	376,648

Depreciation expense was $35,829 and $39,467 for the three months ended June 30, 2023 and 2022, respectively. Depreciation expense was $77,238 and $80,576 for the six months ended June 30, 2023 and 2022, respectively.

Accrued Expenses

Accrued expenses consist of the following:


	June 30,		December 31
	2023		2022
Professional fees	$	94,856	$	608,846
Employee compensation costs		2,454,370		1,364,142
Other liabilities		54,292		65,303
Total accrued expenses and other current liabilities	$	2,603,518	$	2,038,291

Share-Based Compensation

For the three months ended June 30, 2023 and 2022, share-based compensation expense was $0.1 million and $0.2 million, respectively. For the six months ended June 30, 2023 and 2022, share-based compensation expense was $0.3 million and was $0.3 million, respectively. As of June 30, 2023, there was $0.3 million of unrecognized compensation cost related to unvested stock-based compensation arrangements that is expected to be recognized over a weighted average period of 0.6 years.

The following table summarizes the stock option activity:


	Number of Options			Weighted-average exercise price per share		Weighted average remaining contractual term (in years)		Aggregate intrinsic value
Outstanding at December 31, 2022		1,750,967		$	5.36		2.9	$	486,097
Granted		—		$	—
Cancelled/Forfeited		(1,865	)	$	8.05
Exercised		—		$	—
Outstanding at June 30, 2023		1,749,102		$	5.36		2.5	$	107,407
Exercisable at June 30, 2023		1,525,334		$	4.97		2.1	$	107,407

The following table summarizes information related to share-based compensation expense recognized in the condensed consolidated statements of operations and comprehensive loss related to the equity awards:


	Three months ended June 30,				Six months ended June 30,
	2023		2022		2023		2022
Research and development	$	98,385	$	112,367	$	200,873	$	208,024
General and administrative		35,052		53,410		97,571		65,767
Total equity-based compensation	$	133,437	$	165,777	$	298,444	$	273,791

For the six months ended June 30, 2023, the Company extended the term of certain outstanding options to allow the exercise of these options for an additional one year period. The fair value of the stock options is estimated on the date of grant and modification using a Black-Scholes option pricing model with the following weighted average assumptions:


	Six months ended June 30,
	2023			2022
Expected volatility		79.3	%		75.1	%
Risk-free interest rate		4.66	%		1.81	%
Expected term (in years)		1.0			7.0
Expected dividend yield		0	%		0	%

Fair Value of Financial Instruments

In accordance with ASC 820, Fair Value Measurements and Disclosures, fair value is defined as the exit price, or the amount that would be received for the sale of an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date. The guidance also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs

by requiring that the most observable inputs be used when available. Observable inputs include those that market participants would use in valuing the asset or liability and are developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors that market participants would use in valuing the asset or liability.

The Company’s financial assets and liabilities are measured at fair value and classified within the fair value hierarchy which is defined as follows:

•

Level 1 — Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

•

Level 2 — Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly.

•

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company believes the carrying amounts of its cash and cash equivalents, related party loan and debt approximate their fair values due to their near-term maturities.

The following table presents a roll-forward of the fair value of the derivative liability, derivative asset and warrant liability that will continue to be measured at fair value on a recurring basis for which fair value is determined based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy as of June 30, 2023. The valuation models used to determine the fair value at each reporting date require management judgment and pricing inputs from observable and unobservable markets, including projected share prices and probabilities of success. Significant deviations from these estimates and inputs could result in a material change in fair value.


	Derivative Liability			Derivative Asset			Warrant Liability
Balance at December 31, 2022	$	166,000		$	13,000		$	525,000
Fair value adjustments		(1,000	)		(13,000	)		(525,000	)
Balance at March 31, 2023	$	165,000		$	—		$	—
Issuance of 2023 convertible notes and warrants		560,436			—			1,615,194
Issuance of related party convertible notes and warrants		288,710			—			786,967
Exercise of warrants		—			—			(244,261	)
Fair value adjustments		548,233			—			712,857
Balance at June 30, 2023	$	1,562,379		$	—		$	2,870,757

The derivative liability, accounted for under ASC 480, “Distinguishing Liabilities from Equity,” related to the $1,512,500 convertible note for the embedded beneficial conversion feature for the settlement of the notes upon maturity was initially valued at $165,000 based on the following inputs: the estimated probability of maturity of 100%, the 10% discount awarded upon conversion and a discount rate of 10%.

The derivative asset, accounted for under ASC 815, “Derivatives and Hedging,” for a put option related to the Key Company Stockholder Forward Purchase Agreement entered into in April 2022 had a fair value of $13,000 on December 31, 2022, which is considered to be a Level 3 fair value measurement, as the fair value was determined based on significant inputs not observable in the market. The significant unobservable inputs used to determine the fair value is the probability of the key company stockholder obtaining a margin loan and the Company meeting the NASDAQ listing requirements. The fair value of the Key Company Stockholder Forward Purchase Agreement at December 31, 2022 was valued using a probability weighted scenario analysis with a Black Scholes Option Pricing Model based on a stock price of $4.21, expected volatility of 82.2%, risk-free rate of 4.5% and discounted at 0.5% for the probability of the Company closing the Business Combination Agreement, the key company stockholder obtaining a margin loan and the Company meeting the NASDAQ listing requirements. The fair value of the Key Company Stockholder Forward Purchase Agreement at March 31, 2023 was valued at $0 as the time to fund concluded on March 31, 2023, resulting in a change in fair value of derivative asset of $13,000 for the six months ended June 30, 2023. In April 2023, this agreement was cancelled due to the Company's failure to satisfy the condition that the Company's common stock continue to be listed on Nasdaq as

required by the agreement.

The White Lion Purchase Agreement qualifies as a standby equity purchase agreement under ASC 815 “Derivatives and Hedging” and includes an embedded put option and an embedded forward option. The put option is recognized on inception and the forward option is recognized upon issuance of notice for the sale of the Company's common stock. As at December 31, 2022, there were no notices issued to White Lion for the sale of common stock of the Company. The derivative liability, accounted for under ASC 815, “Derivatives and Hedging,” for a put option related to the White Lion Purchase Agreement entered into on November 3, 2022 had a fair value of $1,000 on December 31, 2022, which is considered to be a Level 3 fair value measurement as the fair value was determined based on significant inputs not observable in the market. The significant unobservable inputs used to determine the fair value were the projected volume weighed average share price at each trading date and the use of the maximum draw down potential. The fair value at December 31, 2022 of the White Lion Purchase Agreement was determined using a Monte Carlo simulation based on the projected stock price of $4.19, expected volatility of 81.0%, risk-free rate of 4.16% and discounted at 0.25% for the probability of the Company timely filing all SEC documents and meeting the NASDAQ listing requirements. The fair value of the White Lion Purchase Agreement at June 30, 2023 was valued using a Monte Carlo simulation based on the projected stock price of $0.83, expected volatility of 88%, risk-free rate of 4.63% and discounted by 2.5% for the probability of the Company timely filing all SEC documents and meeting the OTC Market listing requirements resulting in a change in fair value of $1,000 for the six months ended June 30, 2023 and a derivative liability of $0 at June 30, 2023.

In November 2022, upon consummation of the Business Combination, the Company assumed 2,500,000 Private Placement Warrants (as defined in Note 10). The Private Placement Warrants were accounted for under ASC 815, “Derivatives and Hedging,” pursuant to which the Private Placement Warrants do not meet the criteria for equity classification and must be recorded as liabilities. The Private Placement Warrants were valued using a Modified Black Scholes Option Pricing Model, which is considered to be a Level 3 fair value measurement, as the fair value was determined based on significant inputs not observable in the market. The fair value of the Private Placement Warrants was discounted to present value at June 30, 2023, utilizing the Company's stock price of $0.83, a risk-free rate of 4.13%, and expected volatility of 46% of the Company's common stock.

In April 2023, the Company entered into separate subscription agreements (the “2023 Convertible Note and Warrant Subscription Agreements”) for the purchase of convertible promissory notes in the aggregate principal amount of $2,195,034 (the “2023 Convertible Notes”) and an aggregate amount of 3,658,390 warrants (the “2023 Convertible Note Warrants”). The Company also issued 209,670 Placement Agent Warrants with the same terms as the 2023 Convertible Note Warrants. The 2023 Convertible Note Warrants and the Placement Agent Warrants were accounted for under ASC 815, “Derivatives and Hedging,” pursuant to which the 2023 Convertible Note Warrants and Placement Agent Warrants do not meet the criteria for equity classification and must be recorded as liabilities. The 2023 Convertible Note Warrants and Placement Agent Warrants were valued using a Black Scholes Option Pricing Model, which is considered to be a Level 3 fair value measurement, as the fair value was determined based on significant inputs not observable in the market. The initial fair value was determined to be $1.6 million based on the following assumptions: stock price of $0.655, expected volatility of 72.8%, risk-free rate of 3.51% and expected term of 5 years. The fair value at June 30, 2023 was valued at $2.2 million using a Black Scholes Option Pricing Model based on the following assumptions: stock price of $0.83, expected volatility of 72.5%, risk-free rate of 4.13% and expected term of 4.83 years. The Company recorded a change in fair value of $0.5 million for the three and six months ended June 30, 2023. The 2023 Convertible Notes were also accounted for under ASC 815, “Derivatives and Hedging,” pursuant to which the Company recognized a derivative liability for the embedded beneficial conversion feature for the settlement of the notes upon maturity. The derivative liability was valued using a Black Scholes Option Pricing Model, which is considered to be a Level 3 fair value measurement, as the fair value was determined based on significant inputs not observable in the market. The initial fair value was determined to be $0.6 million based on the following assumptions: stock price of $0.655, expected volatility of 66.5%, risk-free rate of 4.94% and expected term of 0.5 years. The fair value at June 30, 2023 was valued at $0.9 million using a Black Scholes Option Pricing Model based on the following assumptions: stock price of $0.83, expected volatility of 50.5%, risk-free rate of 5.35% and expected term of 0.33 years. The Company recorded a change in fair value of $0.3 million for the three and six months ended June 30, 2023.

The following table summarizes the 2023 Convertible Notes and Warrant Subscription Agreement:


	Convertible Notes			Derivative Liability		Warrant Liability		Total
Issuance of 2023 convertible notes and warrants		106,957			560,436		1,527,641		2,195,034
Issuance of Placement Agent warrants							87,553
Debt issuance costs		(64,871	)		—		—		—
Accretion expense		743,976			—		—		743,976
Fair value adjustments		—			361,836		568,162		929,998
Balance at June 30, 2023	$	786,062		$	922,272	$	2,183,356	$	3,869,008

In April 2023, the Company entered into a subscription agreement with its founder and director to settle $1,130,775 in related party loans made to the Company. The Company issued a $1,130,775 related party unsecured convertible promissory note and warrants to purchase 1,884,625 shares of common stock at $0.60 per share (the “Founder and Director Warrants”.) The Founder and Director Warrants were accounted for under ASC 815, “Derivatives and Hedging,” pursuant to which the Founder and Director Warrants do not meet the criteria for equity classification and must be recorded as liabilities. The Founder and Director Warrants were valued using a Black Scholes Option Pricing Model, which is considered to be a Level 3 fair value measurement, as the fair value was determined based on significant inputs not observable in the market. The initial fair value was determined to be $0.8 million based on the following assumptions: stock price of $0.655, expected volatility of 72.8%, risk-free rate of 3.51% and expected term of 5 years. In June 2023, the founder and director exercised 666,667 of their warrants for total proceeds of $400,000. The Company recognized a capital contribution of $0.2 million using a Black Scholes Option Pricing Model based on the following assumptions: stock price of $0.598, expected volatility of 72.0%, risk-free rate of 4.03% and expected term of 4.85 years. The fair value at June 30, 2023 for the remaining 1,217,958 Founder and Director Warrants was valued at $0.7 million using a Black Scholes Option Pricing Model based on the following assumptions: stock price of $0.83, expected volatility of 72.5%, risk-free rate of 4.13% and expected term of 4.83 years. The Company recorded a change in fair value of $0.1 million for the three and six months ended June 30, 2023. The Founder and Director Convertible Notes was also accounted for under ASC 815, “Derivatives and Hedging,” pursuant to which the Company recognized a derivative liability for the embedded beneficial conversion feature for the settlement of the notes upon maturity. The derivative liability was valued using a Black Scholes Option Pricing Model, which is considered to be a Level 3 fair value measurement, as the fair value was determined based on significant inputs not observable in the market. The initial fair value was determined to be $0.3 million based on the following assumptions: stock price of $0.655, expected volatility of 66.5%, risk-free rate of 4.94% and expected term of 0.5 years. The fair value at June 30, 2023 was valued at $0.5 million using a Black Scholes Option Pricing Model based on the following assumptions: stock price of $0.83, expected volatility of 50.5%, risk-free rate of 5.35% and expected term of 0.33 years. The Company recorded a change in fair value of $0.2 million for the three and six months ended June 30, 2023.

The following table summarizes the Related Party Convertible Notes and Warrant Subscription Agreement:


	Convertible Notes		Derivative Liability		Warrant Liability			Total
Issuance of related party convertible notes and warrants		1,069,467		288,710		786,967			2,145,144
Accretion expense		20,436		—		—			20,436
Exercise of warrants						(244,261	)		(244,261	)
Fair value adjustments				186,397		144,695			331,092
Balance at June 30, 2023	$	1,089,903	$	475,107	$	687,401		$	2,252,411

The Company believes the carrying amounts of its cash and cash equivalents, related party loan and current note payable approximate their fair values due to their near-term maturities. There were no transfers among Level 1, Level 2 or Level 3 categories in the six months ended June 30, 2023 and 2022.

Related Party Transactions and Shared Service Costs

Transactions entered into between the Company and pH Pharma Ltd prior to April 1, 2022 were included within the condensed consolidated financial statements and are considered related party transactions and have been adjusted to Deficit within the condensed consolidated balance sheets and statements of cash flows as they represent an investment to the Company. The components of the net transfers from pH Pharma Ltd as of June 30, 2022 are as follows:


	For the Three Months Ended		For the Six Months Ended
	June 30, 2022		June 30, 2022
Corporate allocations
Research and development	$	—	$	482,160
Selling, general and administrative		—		72,345
Accounts payable and general financing activities		—		809,469
Net increase in contributions from member	$	—	$	1,363,974

On March 1, 2022, the Company and pH Pharma Ltd entered into an administrative services and facilities agreement whereby pH Pharma Ltd will perform services, functions and responsibilities for the Company. Under the agreement, the Company paid pH Pharma Ltd $100,000 per month through August 30, 2022 and paid $15,000 from September 1, 2022 through February 28, 2023 based on the estimated value of the level of service to be performed. Additionally, the Company will pay pH Pharma Ltd $3,000 per month in lease payments. At June 30, 2023 and December 31, 2022, the Company recorded a liability to accounts payable of $342,247 and $426,673 related to this agreement.

At June 30, 2023 and December 31, 2022, the Company recorded a liability of $2,379,000 and $1,885,843 for unpaid compensation due to current and former directors and officers of which $2,149,050 and $1,095,043 respectively, is included in accrued expenses and $230,650 and $790,800 respectively is included in other non-current liabilities of which is included in accrued liabilities.

Employment Agreements

In January 2022, the Company entered into an employment agreement with its founder and director. The effective date of the employment agreement was February 1, 2022, and was subject to the completion of the Business Combination. As part of the agreement, the Company agreed to repay its founder and director $1.5 million in forwent salary over a period of four years. Further, the employment agreement provides for the payment of success fees in connection with future business or corporate development transactions (licensing, product development and acquisitions).

In March 2022, the Company entered into an employment agreement with its chief operating officer which was subject to the completion of the Business Combination. The agreement provides for confirmation of Peak Bio’s previously agreed upon success fee payment upon consummation of the business combination with Ignyte in the amount of $250,000 and the payment of success fees in connection with future business or corporate development transactions (licensing, product development and acquisitions).

Leases

On January 1, 2022, the Company adopted ASC 842 using the modified retrospective transition approach allowed under ASU 2018-11 which releases companies from presenting comparative periods and related disclosures under ASC 842. The Company adopted the standard under the modified retrospective approach and the effective date is as of the initial application. Consequently, financial information was not updated, and the disclosures required under ASU 2016-02 are not provided for dates and periods prior to January 1, 2022. The Company is party to one operating lease for office and laboratory space. The Company does not have any finance leases. The Company has elected to apply the short-term lease exception to all leases of one year or less. As of June 30, 2023, this exception does not apply to any of the operating leases for office and laboratory space. Further, the Company has applied the guidance in ASC 842 to our corporate office and laboratory leases and have determined that these should be classified as operating leases. Consequently, as a result of the adoption of ASC 842, we recognized a ROU lease asset of approximately $4.2 million with a corresponding lease liability of approximately $4.4 million based on the present value of the minimum rental payments of such leases. In accordance with ASC 842, the beginning balance of the ROU lease asset was reduced by the existing deferred rent liability at inception of approximately $241,000.

In October 2021, the Company entered into a lease for laboratory and office facilities in Palo Alto, California that expires in April 2027 with a five-year renewal option and opened a secured letter of credit with a third-party financial institution in lieu of a security deposit for $177,000. Base rent for this lease is approximately $89,000 monthly with annual escalations of 3%. In March 2023, the Company vacated the premises and returned

possession of the premises to the landlord in April 2023. The full amount of the security deposit has been applied to back rent and the Company is still responsible for the outstanding payments under the lease. The Company recognized a $3.5 million impairment loss on operating lease right of use asset for the six months ended June 30, 2023.

Rent expense for the three months ended June 30, 2023 and 2022 was $0.1 million and $0.2 million, respectively. Rent expense for the six months ended June 30, 2023 and 2022 was $0.4 million and $0.5 million, respectively.

Quantitative information regarding the Company’s leases for the three and six months ended June 30, 2023 and 2022 is as follows:


	Three months ended June 30,						Six months ended June 30,
	2023			2022			2023			2022
Operating cash flows paid for amounts included in the measurement of lease liabilities	$	-		$	66,265		$	177,111		$	207,807
Operating lease liabilities arising from obtaining right of use assets	$	-		$	-		$	-		$	4,189,492
Weighted-average remaining lease terms (years)		3.8			5.0			3.8			5.0
Weighted-average discount rate		10.0	%		10.0	%		10.0	%		10.0	%

Future lease payments under noncancelable leases are as follows at June 30, 2023:


	Operating Lease
2023 (remaining six months)	$	979,745
2024		1,189,454
2025		1,223,029
2026		1,257,612
2027		422,107
Thereafter		—
Total future minimum lease payments	$	5,071,947
Less: imputed interest		(817,368	)
Total future minimum lease payments	$	4,254,579

Commitments and Contingencies

From time to time, the Company may be involved in litigation relating to claims arising out of operations in the normal course of business. As of June 30, 2023, there were no pending or threatened lawsuits that could reasonably be expected to have a material effect on the Company’s results of operations. At each reporting period, the Company evaluates known claims to determine whether a potential loss amount or a potential range of loss is probable and reasonably estimable under ASC 450, Contingencies. Legal fees are expensed as incurred.

10.

Stockholders' Equity

Preferred Stock

The Company is authorized to issue 10,000,000 shares of preferred stock with a par value of $0.0001 per share, of which no shares were issued and outstanding at June 30, 2023.

Common Stock

Peak Bio, Inc. is authorized to issue 60,000,000 shares of common stock with a par value of $0.0001 per share. The Spin-Off (as defined below) was completed on March 1, 2022, prior to the execution of the Business Combination Agreement, with Peak Bio retaining 8,283,613 shares of the Company's common stock.

In May 2022, the Company entered into an agreement with a certain investor in which the investor purchased an aggregate of 63,856 shares of the Peak Bio Co., Ltd. common stock for aggregate gross proceeds of approximately $1.2 million.

PIPE Subscription Agreements

In November 2022, concurrently with the closing of the Business Combination, the Company entered into subscription agreements with certain investors in which the investors purchased, in a private placement, an aggregate of 302,500 shares of common stock and 281,325 warrants to purchase shares of Ignyte common stock, at an exercise price of $0.01 per share for aggregate gross proceeds of $3.025 million. The warrants are on terms substantially the same as the outstanding warrants that were included in the units issued in Ignyte's initial public offering, except that the warrants are non redeemable, and the warrants are exercisable for one year.

Forward Purchase Agreement

On December 29, 2022, the Company purchased 375,939 shares of our common stock at a price of $10.115 per share following the exercise of an investor’s right to sell up to 450,000 shares of common stock under a previously disclosed Forward Purchase Agreement entered into on October 25, 2022. The 375,939 shares of common stock have been retired. As a result of that exercise, funds in the amount of $4,551,750 being held in escrow in connection with the Forward Purchase Agreement were distributed as follows: $749,127 to us and $3,802,623 to the investor.

Additional PIPE Subscription Agreement

In December 2022, the Company entered into a subscription agreement whereby the Company agreed to issue and sell to the investor party thereto, in a private placement, (i) 50,000 shares of our common stock at $10.00 per share and (ii) 46,500 warrants to purchase shares of our common stock, at an exercise price of $0.01 per share. The warrants are on terms substantially the same as the outstanding warrants that were included in the units issued in Ignyte’s initial public offering, except that the warrants are not redeemable, and the warrants are exercisable for one year.

Key Company Stockholder Agreements

In April 2022, the Company entered into a forward purchase agreement (the “Key Company Stockholder Forward Purchase Agreement”) with its founder and director, Hoyoung Huh (the “Key Company Stockholder”). Pursuant to the terms of the Key Company Stockholder Forward Purchase Agreement, the Key Company Stockholder would, subject to the receipt of margin financing within 180 days following the closing of the Business Combination, purchase shares of the Company's common stock at a purchase price of $10.00 per share in a private placement (the “Key Company Stockholder Purchase”) for up to an aggregate amount of $10,000,000 (the “Subscription Amount”), subject to the conditions set forth in the Key Company Stockholder Forward Purchase Agreement. The Company recorded a derivative liability for this agreement (see Note 6).

In December 2022, the Company and the Key Company Stockholder entered into an amendment to the Key Company Stockholder Forward Purchase Agreement (the “Amendment to Key Company Stockholder Forward Purchase Agreement”), pursuant to which (i) the Key Company Stockholder Purchase is no longer subject to the receipt of margin financing as a condition precedent, (ii) the Key Company Stockholder agreed to fund the Subscription Amount on or prior to March 31, 2023 and (iii) the Key Company Stockholder Purchase would be consummated at a purchase price of $5.18 per share of the Company's common stock. Accordingly, upon closing of such purchase, the Key Company Stockholder will receive 1,930,501 shares of common stock in exchange for his $10.0 million investment in the Company.

In April 2023, the Company received notice from its founder and director informing the Company that he would not consummate the purchase of the Key Company Stockholder Forward Purchase Agreement as a result of the Company’s failure to satisfy the condition that the Company's common stock continue to be listed on Nasdaq as required by the agreement. As a result, the Company cancelled and forfeited the 1,930,501 shares of common stock being held in escrow.

White Lion Common Stock Purchase and Registration Rights Agreements

On November 3, 2022, the Company entered into a Common Stock Purchase Agreement (as amended, the “White Lion Purchase Agreement") and Registration Rights (the “White Lion RRA”) with White Lion Capital, LLC, a Delaware limited liability company (“White Lion”). Pursuant to the White Lion Purchase Agreement, the

Company has the right, but not the obligation, to require White Lion to purchase, from time to time, up to $100,000,000 in aggregate gross purchase price of newly issued shares of its common stock, subject to certain limitations and conditions set forth in the White Lion Purchase Agreement. Capitalized terms used but not otherwise defined in this section shall have the meanings given to such terms by the White Lion Purchase Agreement and the White Lion RRA. The Company recorded a derivative liability for this agreement (see Note 6).

The Company is obligated under the White Lion Purchase Agreement and the White Lion RRA to file a registration statement with the SEC to register the common stock under the Securities Act, for the resale by White Lion of shares of common stock that the Company may issue to White Lion under the White Lion Purchase Agreement.

Subject to the satisfaction of certain customary conditions including, without limitation, the effectiveness of a registration statement registering the shares issuable pursuant to the White Lion Purchase Agreement, the Company's right to sell shares to White Lion will commence on the effective date of the registration statement and extend until November 1, 2025. During such term, subject to the terms and conditions of the White Lion Purchase Agreement, the Company may notify White Lion when it exercises its right to sell shares (the effective date of such notice, a “Notice Date”).

The number of shares sold pursuant to any such notice may not exceed (i) the lower of (a) the Purchase Notice Fixed Limit (described below) and (b) the product of (1) the Average Daily Trading Volume (as defined in the White Lion Purchase Agreement), and (2) the applicable Percentage Limit (as defined in the White Lion Purchase Agreement). The Purchase Notice Fixed Limit is $500,000 upon payment of the Initial Commitment Shares (as defined in the White Lion Purchase Agreement) and can be increased in two tranches: (A) to $1,000,000 following an aggregate purchase of $5,000,000 shares and issuance by the Company to White Lion of an additional $250,000 in Commitment Shares, and (B) to $2,000,000 following an aggregate purchase of $10,000,000 shares and issuance by the Company for payment of an additional $250,000 in Commitment Shares (as defined in the White Lion Purchase Agreement).

The applicable Percentage Limit is 40% or 150% depending on the price the Company agrees to sell shares to White Lion. At an applicable Percentage Limit of 40%, the Purchase Price to be paid by White Lion for any such shares will equal 97% of lowest daily volume-weighted average price of common stock during a period of two consecutive Trading Days following the applicable Purchase Notice Date (as defined in the White Lion Purchase Agreement) until an aggregate of $50,000,000 in Purchase Notice Shares (as defined in the White Lion Purchase Agreement) have been purchased under White Lion Purchase Agreement, at which point the Purchase Price (as defined in the White Lion Purchase Agreement) to be paid by White Lion will equal 98% of the lowest daily volume-weighted average price of common stock during a period of two consecutive Trading Days following the applicable Purchase Notice Date. At an applicable Percentage Limit of 150%, the Purchase Price to be paid by White Lion for any such shares will equal 94.5% of the lowest daily volume-weighted average price of common stock during a period of three consecutive Trading Days following the applicable Purchase Notice Date.

The Company will have the right to terminate the White Lion Purchase Agreement at any time after commencement, at no cost or penalty, upon three (3) Trading Days’ prior written notice. Additionally, White Lion will have the right to terminate the White Lion Purchase Agreement upon three (3) days’ prior written notice to the Company if (i) there is a Fundamental Transaction (as defined in the White Lion Purchase Agreement), (ii) the Company is in breach or default in any material respect of the White Lion RRA, (iii) there is a lapse of the effectiveness, or unavailability of, the registration statement for a period of 45 consecutive Trading Days or for more than an aggregate of 90 Trading Days in any 365-day period, (iv) the suspension of trading of the common stock for a period of five (5) consecutive Trading Days, (v) the material breach of the White Lion Purchase Agreement by the Company, which breach is not cured within the applicable cure period or (vi) a Material Adverse Effect (as defined in the White Lion Purchase Agreement) has occurred and is continuing. No termination of the White Lion Purchase Agreement will affect the registration rights provisions contained in the White Lion RRA.

In consideration for the commitments of White Lion, as described above, the Company has agreed that it will issue to White Lion shares of common stock having a value of $250,000 based upon the Closing Sale Price (as defined in the White Lion Purchase Agreement) of common stock two Trading Days prior to the filing of the Initial Registration Statement as Initial Commitment Shares. The Company may increase the number of shares it may sell to White Lion by issuing additional Commitment Shares in two additional tranches of $250,000 each. The Company issued Initial Commitment Shares of 50,200 shares of common stock to White Lion, based upon

the Closing Sale Price of our common stock of $4.98 per share on November 30, 2022.

Concurrently with the execution of the White Lion Purchase Agreement, the Company entered into the White Lion RRA with White Lion in which the Company agreed to register the shares of common stock purchased by White Lion with the SEC for resale within 30 days of the consummation of a business combination. The White Lion RRA also contains usual and customary damages provisions for failure to file and failure to have the registration statement declared effective by the SEC within the time periods specified.

The White Lion Purchase Agreement and the White Lion RRA contain customary representations, warranties, conditions and indemnification obligations of the parties. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

In March 2023, the Company entered into an amendment to the White Lion Purchase Agreement to give the Company the right, but not the obligation to require White Lion to purchase shares of the Company's common stock while trading on the OTC Market. Under the terms of the amendment, at an applicable Percentage Limit of 200%, the Purchase Price to be paid by White Lion for any such shares will equal 90% of the lowest daily volume-weighted average price of common stock during a period of six consecutive Trading Days following the applicable Purchase Notice Date if the Company is listed on the OTC Market with the exception of the OTC Pink or OTC Bulletin Board, in which case the Purchase Price will equal 85% of the lowest daily volume-weighted average price of common stock during a period of six consecutive Trading Days following the applicable Purchase Notice Date. Further, the Company will issue to White Lion within five (5) Trading Days following the effective date of the amendment fully paid, non-assessable shares of the Company's common stock equal to the quotient obtained by dividing (i) $250,000 and (ii) the lowest traded sale price of the common stock of the 10 (ten) Trading Days prior to the effective date of the amendment, minus 50,200. In March 2023, the Company issued 412,763 shares of its common stock to White Lion.

In August 2023, the Company and White Lion entered into a second amendment to the common stock Purchase Agreement (the “Second Amendment”). The Second Amendment includes, among other things, the right of the Company to issue a Purchase Notice (defined in the Second Amendment as an “Accelerated Purchase Notice”) requesting White Lion to purchase newly issued shares of common stock from the Company, subject to acceptance by White Lion, with pricing of the shares to be sold by the Company to White Lion under such Accelerated Purchase Notice determined on the date of issuance by the Company of the Accelerate Purchase Notice and acceptance by White Lion (the date of such notice defined as the “Accelerated Valuation Period”). Such accelerated purchases pursuant to an Accelerated Purchase Notice will be sold to White Lion at a price, defined as an “Accelerated Purchase Price,” equal to the lower of (i) the opening price of common stock during the Accelerated Valuation Period, (ii) the closing price of the common stock during Accelerated Valuation Period, or (iii) the volume weighted average price of the common stock during Accelerated Valuation Period; provided, however, that if at the time the Company delivers an Accelerated Purchase Notice to Investor the price of the common stock is lower than the opening price of the common stock during the Accelerated Valuation Period, the Accelerated Purchase Price will be discounted by 20%. In addition, the Second Amendment provides for an “Accelerated Purchase Notice Limit” equal to 200%.

In addition, in the event the Company does not issue Purchase Notices (as defined in the White Lion Purchase Agreement) to White Lion providing for the purchase of at least $1,250,000 of Purchase Shares (as defined in the White Lion Purchase Agreement and Second Amendment) in the aggregate within 180 days following the effective date of the amendment, the Company will issue to White Lion an additional number of fully paid, non-assessable shares of common stock equal to the quotient obtained by dividing (i) $150,000 and (ii) the lowest Closing Sale Price (as defined in the White Lion Purchase Agreement and Second Amendment) of common stock of the 10 (ten) Trading Days prior to the 180th day following the effective date of the amendment.

Public Warrants

In November 2022, upon consummation of the Business Combination, the Company assumed 2,875,000 public warrants (the “Public Warrants”). Each Public Warrant entitles the holder to purchase one share of common stock at a price of $11.50 per share, subject to adjustment as discussed herein. The Public Warrants became exercisable 30 days after the completion of the Business Combination. However, no Public Warrants will be exercisable for cash unless the Company has an effective and current registration statement covering the shares of common stock issuable upon exercise of the Public Warrants and a current prospectus relating to such shares

of common stock. Notwithstanding the foregoing, if a registration statement covering the shares of common stock issuable upon exercise of the Public Warrants is not effective within a specified period following the consummation of the initial Business Combination, warrant holders may, until such time as there is an effective registration statement and during any period when the Company shall have failed to maintain an effective registration statement, exercise warrants on a cashless basis pursuant to the exemption provided by Section 3(a)(9) of the Securities Act, provided that such exemption is available. If that exemption, or another exemption, is not available, holders will not be able to exercise their warrants on a cashless basis. In the event of such cashless exercise, each holder would pay the exercise price by surrendering the warrants for that number of shares of common stock equal to the quotient obtained by dividing (x) the product of the number of shares of common stock underlying the Public Warrants, multiplied by the difference between the exercise price of the Public Warrants and the “fair market value” (defined below) by (y) the fair market value. The “fair market value” for this purpose will mean the average reported last sale price of the shares of common stock for the 5 trading days ending on the trading day prior to the date of exercise. The Public Warrants will expire on the fifth anniversary of the completion of an initial Business Combination, at 5:00 p.m., New York City time, or earlier upon redemption or liquidation.

The Company may call the Public Warrants for redemption:

•

in whole and not in part;

•

at a price of $0.01 per warrant;

•

at any time after the warrants become exercisable,

•

upon not less than 30 days’ prior written notice of redemption to each warrant holder; and

•

if, and only if, the reported last sale price of the common stock equals or exceeds $18.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations) for any 20 trading days within a 30-trading day period commencing at any time after the warrants become exercisable and ending on the third business day prior to the notice of redemption to warrant holders; and

•

if, and only if, there is a current registration statement in effect with respect to the shares of common stock underlying such warrants.

If the Company calls the Public Warrants for redemption as described above, the Company’s management will have the option to require all holders that wish to exercise warrants to do so on a “cashless basis.” In such event, each holder would pay the exercise price by surrendering the Public Warrants for that number of shares of common stock equal to the quotient obtained by dividing (x) the product of the number of shares of common stock underlying the Public Warrants, multiplied by the difference between the exercise price of the Public Warrants and the “fair market value” (defined below) by (y) the fair market value. The “fair market value” for this purpose shall mean the average reported last sale price of the shares of common stock for the 5 trading days ending on the third trading day prior to the date on which the notice of redemption is sent to the holders of Public Warrants.

Private Placement Warrants

In November 2022, upon consummation of the Business Combination, the Company assumed 2,500,000 private placement warrants (the “Private Placement Warrants”). Each Private Placement Warrant will entitle the holder to purchase one share of common stock at a price of $11.50 per share, subject to adjustment.

The Private Placement Warrants are identical to the Public Warrants, except that the Private Placement Warrants are non-redeemable and may be exercised on a cashless basis, in each case so long as they continue to be held by the initial purchasers or their permitted transferees. Further, the Sponsor had agreed not to transfer, assign, or sell the Private Placement Warrants (including the shares of common stock issuable upon the exercise of the Private Placement Warrants), except to certain permitted transferees, until after the consummation of the Business Combination.

A summary of the Company's outstanding warrants at June 30, 2023 is as follows:


Description	Number of Warrants		Exercise price per share		Expiration Date
Private Placement Warrants		2,500,000	$	11.50	11/1/2027
Public Warrants		2,875,000	$	11.50	11/1/2027
Convertible note warrants		3,868,060	$	0.60	4/28/2028
Founder and director warrants		1,217,958	$	0.60	4/28/2028
Other Warrants		492,045	$	0.01	11/1/2023
Outstanding Warrants		10,953,063

The following table summarizes the warrant activity:


	Number of Warrants			Weighted-average exercise price per share		Weighted average remaining contractual term (in years)
Outstanding at December 31, 2022		5,867,045		$	10.54		4.01
Issued		5,752,685		$	0.60		4.83
Expired		—		$	—
Exercised		(666,667	)	$	0.60
Outstanding at June 30, 2023		10,953,063		$	5.92		4.39

11.

Grant Revenue

Government grants

Department of Defense, US Army Medical Research Acquisition Activity – this grant is for work on a COVID-19 therapeutic with a potential of $4.0 million, awarded in stages starting in January 2021 and with potential stages running through September 2026. For the three months ended June 30, 2023 and 2022, grant revenue of $0 and $100,916 was recognized from this grant. For the six months ended June 30, 2023 and 2022, grant revenue of $13,854 and $153,866 was recognized from this grant. Approximately $2.9 million in funding remains available for this grant at June 30, 2023.

12.

Debt

Related Party Loans

In August 2021, the Company received proceeds from a loan in the amount of approximately $1.5 million from its founder and director. The loan, which was scheduled to mature on July 31, 2022, bears interest at a rate of 1.0% per annum. The loan is evidenced by a promissory note dated August 6, 2021, which contains customary events of default relating to, among other things, payment defaults and breaches of representations and warranties. The loan may be prepaid by the Company at any time prior to maturity with no prepayment penalties.

In January 2022, the Company entered into an employment agreement with its founder and director. As part of the agreement, the Company agreed to repay $0.5 million of the $1.5 million outstanding under the related party loan upon closing of the Ignyte transaction. The remaining $1.0 million plus accrued interest will be repaid pursuant to the discretion of the Company’s Board of Directors. The Company repaid $150,000 of the loan in December 2022. In April 2023, a portion of this related party loan was settled through the issuance of a related party convertible note payable (as described below). At June 30, 2023 and December 31, 2022, there was $0.9 million and $1.35 million, respectively, outstanding under this loan.

In April 2022, the Company entered into an agreement with its founder and director, in consideration of the repayment to be made by the Company’s founder and director to settle a contractual obligation for the upfront payment received by the Company associated with the License Agreement with Venn. Per the agreement, the Company agreed to repay its founder and director $400,000, with interest to accrue on the unpaid principal balance at the rate of 1% per annum. The timing of the repayment will be determined and pursuant to the discretion of the Company’s Board of Directors.

In May 2022, the Company’s founder and director repaid to Venn the $400,000 upfront payment and the License Agreement was terminated. In April 2023, this related party loan was settled through the issuance of a related party convertible note payable (as described below). At June 30, 2023 and December 31, 2022, the Company recorded a liability to related party loans of $0 and $400,000, respectively, related to this payment.

In May 2022, the Company received proceeds from a loan in the amount of approximately $23,000 from an employee of the Company to settle certain payables of the Company. The loan accrues interest at 4% per annum and was repaid in December 2022.

In September 2022, the Company received proceeds from a loan in the amount of $500,000 from one of its director nominees. The loan matures on the second anniversary and bear interest at a rate of 5.0% per annum. The loan was evidenced by a promissory note, which contains customary events of default relating to, among other things, payment defaults and breaches of representations and warranties. The loan may be prepaid by the Company at any time prior to maturity without the consent of the lender.

In November 2022, the related party loan entered into in September 2022 was amended resulting in the outstanding principal and accrued interest under the related party loan converting at a price of $10.00 per share into 50,273 shares of common stock along with a warrant to purchase 46,754 shares of common stock with an exercise price of $0.01 per share.

In November 2022, upon consummation of the Business Combination, the Company assumed a promissory note of $211,643 with Ignyte Sponsor LLC. The principal balance of the note was payable in cash upon consummation of the Business Combination. No interest shall accrue on the unpaid principal balance of the Note. At December 31, 2022, the Company recorded a liability for the promissory note of $211,643. In May 2023, all amounts owed under this promissory note were cancelled and forgiven and the Company recognized a capital contribution from the related party of $211,643 for the three and six months ended June 30, 2023.

In March 2023, the Company received proceeds from a loan in the amount of $250,000 from its founder and director. The loan matures on December 31, 2023 and bear interest at a rate of 5.0% per annum. The loan was evidenced by a promissory note, which contains customary events of default relating to, among other things, payment defaults and breaches of representations and warranties. The loan may be prepaid by the Company at any time prior to maturity without the consent of the lender. In April 2023, this related party loan was settled through the issuance of a convertible note payable, related party (see below).

Insurance Financing Payable

The Company obtained financing for certain Director & Officer liability insurance policy premiums. The agreement assigns First Insurance Funding (Lender) a first priority lien on and security interest in the financed policies and any additional premium required in the financed policies including (a) all returned or unearned premiums, (b) all additional cash contributions or collateral amounts assessed by the insurance companies in relation to the financed policies and financed by Lender, (c) any credits generated by the financed policies, (d) dividend payments, and (e) loss payments which reduce unearned premiums. If any circumstances exist in which premiums related to any Financed Policy could become fully earned in the event of loss, Lender shall be named a loss-payee with respect to such policy.

The total premiums, taxes and fees financed is approximately $1,006,342 with an annual interest rate of 7.20%. In consideration of the premium payment by Lender to the insurance companies or the Agent or Broker, the Company unconditionally promises to pay Lender the amount Financed plus interest and other charges permitted under the Agreement. At June 30, 2023 and December 31, 2022, the Company recognized approximately $230,394 and $921,576, respectively, as an insurance financing note payable in its consolidated balance sheets. The Company will pay the insurance financing through monthly installment payments through August 1, 2023.

Convertible Notes Payable

From July through September 2022, the Company received proceeds from loans in the amount of $1.25 million from several lenders. The loans mature on the second anniversary and bear interest at a rate of 5.0% per annum. The loans were evidenced by promissory notes, which contain customary events of default relating to, among other things, payment defaults and breaches of representations and warranties. The loans may not be prepaid by the Company at any time prior to maturity without the consent of the lender. The Company will provide for the conversion of the principal and interest of the loans into shares of common stock at fair market value and

25% warrant coverage on common stock prior to the consummation of the Business Combination. Warrant coverage is conditioned on closing of the Business Combination and will be exercisable after the closing of the Business Combination with an exercise price of $0.01. Upon issuance, the Company elected the fair value option to account for the promissory notes, including the component related to accrued interest.

In November 2022, the Company amended the terms to provide warrant coverage on the conversion of the loans from 25% to 93% warrant coverage on common stock. The outstanding principal and accrued interest under the promissory notes converted at a price of $10.00 per share into 126,306 shares of common stock along with warrants to purchase 117,465 shares of common stock with an exercise price of $0.01 per share.

On November 1, 2022, the Company issued a $1,512,500 convertible note. The convertible note accrues interest at a rate of 8% per annum and is payable on October 31, 2023, provided however that the Company agrees to make mandatory prepayments on this note (which shall first be applied to accrued interest and then to principal) from time to time in amounts equal to 15% of the gross proceeds received by the Company from any equity lines, forward purchase agreements or other equity financings consummated by Company prior to the maturity date.

On the maturity date, the note holder may, in its sole and absolute discretion, convert all or part of the principal and/or accrued interest of this convertible note into shares of common stock of the Company at a per share conversion price equal to 90% of the volume weighted average price of a share of common stock of the Company for the five trading days immediately prior to the maturity date. The Company determined that the conversion upon maturity represents an embedded derivative that requires bifurcation and separate accounting. The Company determined the embedded derivative liability fair value to be $165,000 and recorded the remaining proceeds to convertible note payable. The fair value of the derivative liability at June 30, 2023 and December 31, 2022 was $165,000. The allocation of funds to the derivative liability resulted in a discount to the convertible notes of $165,000 which is being amortized to interest expense over the term of the convertible notes. The Company recorded interest expense for the three and six months ended June 30, 2023 related to the amortization of the discount to the convertible notes of $41,250 and $82,047, respectively.

Convertible Notes Payable, Related Party

The following table presents the roll forward of the convertible notes payable and related party convertible notes payable:


	Convertible Notes		2023 Convertible Notes		Related Party Convertible Notes
Balance at December 31, 2022	$	1,374,698	$	—	$	—
Accretion expense		40,797		—		—
Balance at March 31, 2023	$	1,415,495	$	—	$	—
Issuance of 2023 convertible notes				42,086
Issuance of related party convertible notes						1,069,467
Accretion expense		41,250		743,976		20,436
Balance at June 30, 2023	$	1,456,745	$	786,062	$	1,089,903

13.

Income Taxes

For interim financial reporting, the Company estimates its annual effective tax rate based on the projected income for its entire fiscal year and records a provision (benefit) for income taxes on a quarterly basis based on the estimated annual effective income tax rate. Our effective tax rate from continuing operations was 0.0% and 0.23% for the six months ended June 30, 2023 and 2022 respectively. The Company recognized tax expense of $0 for the three and six months ended June 30, 2023 and a tax benefit of $5,800 and $9,300 for the three and six months ended June 30, 2022, respectively.

14.

Subsequent Events

We have concluded that no subsequent events have occurred that require disclosure, except for those referenced below and as disclosed in Note 12 to the consolidated financial statements.

Issuance of Unregistered Securities

As previously disclosed, in April 2023 the Company issued to its founder and director warrants to purchase 1,884,625 shares of the Company’s common stock with an exercise price of $0.60 per share. On July 20, 2023, the Company's founder and director exercised warrants to purchase 458,333 shares of the Company’s common stock at $0.60 per share for a total purchase price of $275,000. On August 14, 2023, the Company' founder and director exercised additional warrants to purchase 583,333 shares of the Company's common stock at $0.60 per share for a total purchase price of $350,000.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of Peak Bio’s financial condition and results of operations together with Peak Bio’s unaudited interim condensed consolidated financial statements and the notes thereto included in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes included in our Annual Report on Form 10-K for the year ended December 31, 2022. Certain of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to plans and strategy for Peak Bio’s business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the section entitled “Risk Factors” of this Quarterly Report and in our Annual Report on Form 10-K for the year ended December 31, 2022, Peak Bio’s actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. You should carefully read the section entitled “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from Peak Bio’s forward-looking statements. Please also see the section entitled “Cautionary Note Regarding Forward-Looking Statements.”

Unless otherwise indicated or the context otherwise requires, references in this Peak Bio’s Management’s Discussion and Analysis of Financial Condition and Results of Operations section to “Peak Bio,” “we,” “us,” “our” and other similar terms refer to Peak Bio Co., Ltd (excluding the Non-Peak Bio Assets transferred in the Spin-Off) prior to the Business Combination and to Peak Bio, Inc. and its consolidated subsidiaries after giving effect to the Business Combination.

Overview

Peak Bio is a clinical-stage biopharmaceutical company focused on developing therapeutics addressing significant unmet need in the areas of oncology and inflammation. Our management team has a combined 50 years of industry experience in the areas of small molecules, antibodies, and antibody-drug-conjugates (ADC).

Our lead product candidate, PHP-303 is a small molecule, 5th generation Phase 2 clinical-ready neutrophil elastase (NE) inhibitor (NEI). We are planning a Phase 2 clinical study in Alpha-1 anti-trypsin deficiency (AATD) patients. We have completed two Phase 1 trials of PHP-303 in healthy volunteers testing higher doses of PHP-303 by single-ascending dose (SAD) and multiple-ascending dose (MAD). PHP-303 demonstrated dose- dependent pharmacokinetics and the recommended Phase 2 dose was achieved in these trials. A maximum tolerated dose for PHP-303 was not achieved in these Phase 1 trials.

In addition, we have leveraged two decades of industry learning in the antibody-drug-conjugate (ADC) field to develop a platform of proprietary technologies that enable us to design ADCs to have improved efficacy, safety, and tolerability relative to existing antibody or ADC therapies. Our most advanced platform, PH-1 or Thailanstatin is being used to generate a pipeline of proprietary ADC product candidates to address patient populations with improved efficacy relative to traditional ADC-based therapies. Our second product candidate is an ADC targeting Trop2, an antigen broadly expressed in solid tumors. We expect our Trop2 ADC to enter clinical development by late 2024. Our Trop2 ADC and other undisclosed discovery-stage product candidates are based on our proprietary PH-1 platform of toxin payloads targeting RNA splicing.

Despite commercial success of the ADCs currently on the market, there continues to be a need for ADCs that not only deliver antibody-directed payloads selectively to their tumors, but to also release them safely via improved linker technology and avoid off- target toxicities. Secondly, we believe that adding an immunomodulatory effect to our toxin(s) that engages our immune systems to assist in the cancer killing would contribute to improved tumor killing.

We do not have any products available for commercial sale, and we have not generated any product revenue from our portfolio of product candidates or other sources. Our ability to generate revenue sufficient to achieve profitability, if ever, will depend on the successful development and eventual commercialization of our potential therapies, which we expect, if it ever occurs, will take a number of years. The research and development efforts require significant amounts of additional capital and adequate personnel infrastructure. There can be no assurance that our research and development activities will be successfully completed, or that our potential therapies will be commercially viable.

We have incurred significant losses since the commencement of our operations. Our net loss was $12.7 for the six months ended June 30, 2023 and $13.1 million and $8.3 million for the years ended December 31, 2022 and 2021, respectively. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we continue our efforts to identify product candidates and seek regulatory approvals within our portfolio of product candidates. These losses have resulted primarily from costs incurred in connection with research and development activities and to a lesser extent from general and administrative costs associated with our operations. Our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our research and development activities.

Recent Developments

Financing

Key Company Stockholder Agreements

In March 2023, we received proceeds from a loan in the amount of $250,000 from our founder and director. The loan matures on December 31, 2023 and bear interest at a rate of 5.0% per annum. The loan was evidenced by a promissory note, which contains customary events of default relating to, among other things, payment defaults and breaches of representations and warranties. The loan may be prepaid by us at any time prior to maturity without the consent of the lender. In April 2023, this related party loan was settled through the issuance of a convertible note payable, related party (see below).

In April 2022, we entered into a forward purchase agreement (the “Key Company Stockholder Forward Purchase Agreement”) with our founder and director, Hoyoung Huh (the “Key Company Stockholder”). In April 2023, we entered into a subscription agreement with our founder and director to replace and supersede the Key Company Stockholder Forward Purchase Agreement, to provide for the conversion of the loans made by the Key Company Stockholder totaling $1,750,000 plus interest into convertible notes and warrants to purchase shares of our common stock, and to cancel and forfeit the 1,930,501 shares of common stock being held in escrow.

White Lion Common Stock Purchase and Registration Rights Agreements

In March 2023, we entered into an amendment to the White Lion Purchase Agreement to give us the right, but not the obligation to require White Lion to purchase shares of our common stock while trading on the OTC Market. Under the terms of the amendment, at an applicable Percentage Limit of 200%, the Purchase Price to be paid by White Lion for any such shares will equal 90% of the lowest daily volume-weighted average price of common stock during a period of six consecutive Trading Days following the applicable Purchase Notice Date if we are listed on the OTC Market with the exception of the OTC Pink or OTC Bulletin Board, in which case the Purchase Price will equal 85% of the lowest daily volume-weighted average price of common stock during a period of six consecutive Trading Days following the applicable Purchase Notice Date. Further, we will issue to White Lion within five (5) Trading Days following the effective date of the amendment fully paid, non-assessable shares of our common stock equal to the quotient obtained by dividing (i) $250,000 and (ii) the lowest traded sale price of the common stock of the 10 (ten) Trading Days prior to the effective date of the amendment, minus 50,200. In March 2023, we issued 412,763 shares of our common stock to White Lion.

In August 2023, the Company and White Lion entered into a second amendment to the Common Stock Purchase Agreement (the “Second Amendment”). The Second Amendment includes, among other things, the right of the Company to issue a Purchase Notice (defined in the Second Amendment as an “Accelerated Purchase Notice”) requesting White Lion to purchase newly issued shares of common stock from the Company, subject to acceptance by White Lion, with pricing of the shares to be sold by the Company to White Lion under such Accelerated Purchase Notice determined on the date of issuance by the Company of the Accelerate Purchase Notice and acceptance by White Lion (the date of such notice defined as the “Accelerated Valuation Period”). Such accelerated purchases pursuant to an Accelerated Purchase Notice will be sold to White Lion at a price, defined as an “Accelerated Purchase Price,” equal to the lower of (i) the opening price of common stock during the Accelerated Valuation Period, (ii) the closing price of the common stock during Accelerated Valuation Period, or (iii) the volume weighted average price of the common stock during Accelerated Valuation Period; provided, however, that if at the time the Company delivers an Accelerated Purchase Notice to Investor the price of the common stock is lower than the opening price of the common stock during the Accelerated Valuation Period, the Accelerated Purchase Price will be discounted by 20%. In addition, the Second Amendment provides for an “Accelerated Purchase Notice Limit” equal to 200%.

In addition, in the event we do not issue Purchase Notices (as defined in the White Lion Purchase Agreement) to White Lion providing for the purchase of at least $1,250,000 of Purchase Shares (as defined in the White Lion Purchase Agreement and Second Amendment) in the aggregate within 180 days following the effective date of the amendment, we will issue to White Lion an additional number of fully paid, non-assessable shares of common stock equal to the quotient obtained by dividing (i) $150,000 and (ii) the lowest Closing Sale Price (as defined in the White Lion Purchase Agreement and Second Amendment) of common stock of the 10 (ten) Trading Days prior to the 180th day following the effective date of the amendment.

Convertible Notes

In April 2023, we entered into separate subscription agreements for the issuance of convertible promissory notes (the "2023 Convertible Notes") in the aggregate principal amount of $2,195,034 and an aggregate amount of 3,658,390 warrants. (the “Warrants”). The 2023 Convertible Notes will be convertible into shares of our common stock at $0.60 per share. For each share into which a 2023 Convertible Note is convertible, the investor received Warrants to purchase an equal amount of shares of our common stock at $0.60 per share. In connection with the issuance of the 2023 Convertible Notes and the Warrants, in consideration for its services in respect of the financing

described above, we also issued the Placement Agent purchase warrants (the “Placement Agent Warrant”) to purchase 209,670 shares of our common stock at a price per share of $0.60. The Placement Agent Warrant has a 5-year term. In addition, we paid the Placement Agent a commission of approximately $125,000.

Convertible Notes Payable, Related Party

In April 2023, we entered into a subscription agreement with our founder and director to settle $1,130,775 in related party loans made to us. We issued a $1,130,775 related party unsecured convertible promissory note and warrants to purchase 1,884,625 shares of our common stock at $0.60 per share.

Issuance of Unregistered Securities

As previously disclosed, in April 2023 we issued to our founder and director warrants to purchase 1,884,625 shares of our common stock with an exercise price of $0.60 per share.

On June 23, 2023, our founder and director exercised warrants to purchase 666,667 shares of our common stock at $0.60 per share for a total purchase price of $400,000.

On July 20, 2023, our founder and director exercised additional warrants to purchase 458,333 shares of our common stock at $0.60 per share for a total purchase price of $275,000.

On August 14, 2023, our founder and director exercised additional warrants to purchase 583,333 shares of our common stock at $0.60 per share for a total purchase price of $350,000.

Components of Results of Operations

Operating Expenses

Prior to April 1, 2022, the consolidated financial statements have been extracted from the accounting records of pH Pharma, Ltd. on a carve-out basis. The historical results of operations, financial position, and cash flows may not be indicative of what we would have been had we been a separate stand-alone entity, nor are they indicative of what the results of operations, financial position and cash flows may be in the future.

The majority of our operating expenses related to research and development (“R&D”). R&D expenses directly related to us were entirely attributed to us in the accompanying consolidated financial statements. R&D salaries, wages and benefits were allocated to us using methodologies based on the proportionate share of R&D expenses for the PHP-303 and PH-1 ADC Platform programs compared to the R&D expenses for pH Pharma Ltd as a whole. We also received services and support from other functions of pH Pharma Ltd. Our operations are dependent upon the ability of these other functions to provide these services and support. The costs associated with these services and support were allocated to us using methodologies based on the proportionate share of R&D expenses for the PHP-303 and PH-1 ADC Platform programs compared to the R&D expenses for pH Pharma Ltd as a whole. These allocated costs were primarily related to corporate administrative expenses, non-R&D employee related costs, including salaries and other benefits, for corporate and shared employees, and other expenses for shared assets for the following functional groups: information technology, legal, accounting and finance, human resources, facilities, and other corporate and infrastructural services. These allocated costs were primarily recorded as R&D expenses and general and administrative (“G&A”) expenses in the statements of operations and comprehensive loss.

The Spin-Off resulted in Peak Bio Co., Ltd. retaining the PHP-303 and PH-1 ADC Platform programs. Historically and throughout the periods presented, the PHP-303 and PH-1 ADC Platform programs have been owned by pH Pharma Co., Ltd and its subsidiaries (prior to the change of its name to Peak Bio Co., Ltd.). The PHP-303 and PH-1 ADC Platform programs have historically operated as a part of pH Pharma Co., Ltd and not as a separate stand-alone entity or group. The Spin-Off resulted in Peak Bio Co., Ltd. retaining approximately 90% of the equity outstanding in pH Pharma Co., Ltd., consisting of 8,283,613 shares of common stock and 693,000 stock options.

As of April 1, 2022, we concluded that all the assets and liabilities of the newly created Peak Bio Co., Ltd. legal entity were contributed by the parent company pH Pharma Ltd. No other assets or liabilities were considered to be attributable to Peak Bio Co., Ltd. or that would be transferred to Peak Bio Co., Ltd. upon the completion of the Business Combination, eliminating the necessity to allocate a portion of pH Pharma Ltd.’s assets and liabilities to Peak Bio Co., Ltd. on a carve-out basis. Therefore, there was no longer a need to allocate assets and liabilities, as well as expenses, from the parent for the consolidated financial statements.

Our consolidated financial statements for the year ended December 31, 2022 include the accounts of Peak Bio Co., Ltd. and its subsidiary, Peak Bio CA., Inc. All intercompany balances and transactions have been eliminated in consolidation.

Revenue

Our revenue has historically been generated through grants from government organizations. We currently have no commercially approved products. Grant revenue is recognized during the period that the research and development services occur, as qualifying expenses are incurred or conditions of the grants are met. We concluded that payments received under these grants represent conditional, nonreciprocal contributions, as described in ASC 958, Not-for-Profit Entities, and that the grants are not within the scope of ASC 606, Revenue from Contracts with Customers, as the organizations providing the grants do not meet the definition of a customer. Qualifying expenses are recognized when incurred as research and development expenses. Expenses for grants are tracked by using a project code specific to the grant, and the employees also track hours worked by using the project code.

Research and Development Expense

We expense research and development costs as incurred. Research and development expense consist primarily of costs related to personnel, including salaries and other personnel related expenses, contract manufacturing and supply, consulting fees, and the cost of facilities and support services used in drug development. Assets acquired that are used for research and development and have no future alternative use are expensed as in-process research and development.

General and Administrative Expenses

Our general and administrative expenses consist primarily of personnel costs, depreciation expense and other expenses for outside professional services, including legal fees relating to patent and corporate matters, human resources, audit and accounting services and facility-related fees not otherwise included in research and development expenses. Personnel costs consist of salaries, benefits and equity-based compensation expense, for our personnel in executive, finance and accounting, business operations and other administrative functions. We expect our general and administrative expenses to increase over the next several years to support our continued research and development activities, manufacturing activities, increased costs of expanding our operations and operating as a public company. These increases will likely include increases related to the hiring of additional personnel, fees to outside consultants, lawyers and accountants, and increased costs associated with being a public company such as expenses related to services associated with maintaining compliance with Nasdaq listing rules and SEC requirements, director and officer insurance premiums and investor relations costs.

Results of Operations for the three months ended June 30, 2023 and 2022

The following table provides selected financial information for the Company:


	Three months ended June 30,						Change
	2023			2022			Amount
Revenues	$	—		$	100,916		$	(100,916	)
Operating expenses
Research and development		371,154			1,168,564			(797,410	)
General and administrative		2,299,058			1,560,182			738,876
Total operating expenses		2,670,212			2,728,746			(58,534	)
Loss from operations		(2,670,212	)		(2,627,830	)		(42,382	)
Other income (expense), net		(3,274,015	)		99,172			(3,373,187	)
Loss before income tax expense	$	(5,944,227	)	$	(2,528,658	)	$	(3,415,569	)

Revenue

Our revenue has historically been generated through grants from government organizations. The total revenue for government grants was $0 and $100,916 for the three months ended June 30, 2023 and 2022, respectively.

Research and Development Expense

The following table summarizes our research and development expenses:


	Three months ended June 30,
	2023		2022
Third-party direct project expenses
PHP-303	$	14,384	$	278,832
PH-1 ADC Platform		77,414		238,658
General program expenses and other pre-clinical programs		—		(120,684	)
Total third-party direct project expenses		91,798		396,806
Other research and development costs
Personnel costs		275,156		353,937
Facilities and other costs		4,199		417,821
Total other research and development costs		279,355		771,758
Total research and development costs	$	371,153	$	1,168,564

Research and development expense decreased by $0.8 million during the three months ended June 30, 2023 compared to the three months ended June 30, 2022. The decrease was primarily due to decreases in direct project expenses related to the PHP-303 programs of $0.3 million and the PH-1 ADC Platform of $0.2 million. In addition, there was a decrease to facilities and other costs of $0.4 million.

General and Administrative Expense

General and administrative expense increased by $0.7 million during the three months ended June 30, 2023 compared to the three months ended June 30, 2022. The increase was primarily driven by an increase in D&O insurance of $0.4 million, increase in wages of $0.4 million and increase in professional fees related to being a public company of $0.4 million, partially offset by a decrease in administrative services of $0.5 million.

Other Income, Net

Other income, net decreased by $3.4 million during the three months ended June 30, 2023 compared to the three months ended June 30, 2022 primarily due to interest expense on the convertible notes payable and related party convertible notes payable of $1.0 million, change in fair value of warrant liability of $0.7 million, change in fair value of derivative liability of $0.5 million, and a loss on extinguishment of debt of $1 million.

Results of Operations for the six months ended June 30, 2023 and 2022

The following table provides selected financial information for the Company:


	Six months ended June 30,						Change
	2023			2022			Amount
Revenues	$	13,854		$	153,866		$	(140,012	)
Operating expenses
Research and development		1,084,260			2,574,737			(1,490,477	)
General and administrative		5,303,880			2,533,008			2,770,872
Impairment loss on operating lease right-of-use asset		3,513,999			—			3,513,999
Total operating expenses		9,902,139			5,107,745			4,794,394
Loss from operations		(9,888,285	)		(4,953,879	)		(4,934,406	)
Other income (expense), net		(2,822,775	)		321,286			(3,144,061	)
Loss before income tax expense	$	(12,711,060	)	$	(4,632,593	)	$	(8,078,467	)

Revenue

Our revenue has historically been generated through grants from government organizations. The total revenue for government grants was $13,854 and $153,866 for the six months ended June 30, 2023 and 2022, respectively.

Research and Development Expense

The following table summarizes our research and development expenses:


	Six months ended June 30,
	2023		2022
Third-party direct project expenses
PHP-303	$	35,995	$	338,066
PH-1 ADC Platform		135,686		388,620
General program expenses and other pre-clinical programs		—		212,581
Total third-party direct project expenses		171,681		939,267
Other research and development costs
Personnel costs		676,890		844,360
Facilities and other costs		235,688		791,110
Total other research and development costs		912,578		1,635,470
Total research and development costs	$	1,084,259	$	2,574,737

Research and development expense decreased by $1.5 million during the six months ended June 30, 2023 compared to the six months ended June 30, 2022. The decrease was primarily due to decreases in direct project expenses related to the PHP-303 programs of $0.3 million, the PH-1 ADC Platform of $0.3 million and general program expenses and other pre-clinical programs of $0.2 million. In addition, there was a decrease in personnel costs of $0.1 million driven by a reduction of staff during 2022 and a decrease to facilities and other costs of $0.6 million.

General and Administrative Expense

General and administrative expense increased by $2.8 million during the six months ended June 30, 2023 compared to the six months ended June 30, 2022. The increase was primarily driven by an increase in D&O insurance of $0.9 million, increase in wages of $0.8 million and increase in professional fees related to being a public company of $1.0 million.

Impairment Loss on Operating Lease Right-of-Use Asset

We recognized an impairment loss on the operating lease right-of-use asset of $3.5 million due to the abandonment of the premises in Palo Alto, California for the six months ended June 30, 2023 and 2022.

Other Income, Net

Other income, net decreased by $3.1 million during the six months ended June 30, 2023 compared to the six months ended June 30, 2022 primarily due to interest expense on the convertible notes payable and related party convertible notes payable of $1.0 million, a fair value adjustment to the warrant liability of $0.2 million, a fair value adjustment of $0.6 million to the derivative liability and a loss on extinguishment of debt of $1 million, partially offset by the receipt of an employee retention credit of $0.3 million during the six months ended June 30, 2022.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. Our net loss was $12.7 million for the six months ended June 30, 2023 and $13.1 million and $8.3 million for the years ended December 31, 2022 and 2021, respectively. At June 30, 2023 we had cash of $0.2 million. Our primary uses of cash to date have been to fund our research and development activities, business planning, establishing and maintaining our intellectual property portfolio, and providing general and administrative support for our operations.

Funding Requirements

We expect to incur losses from operations for the foreseeable future primarily due to research and development expenses, including expenses related to conducting research activities, pre-clinical expenses and clinical trials. Our future capital requirements will depend on a number of factors, including:

•

the scope, progress, results and costs of our clinical trials, including but not limited to PHP-303 and our PH-1 ADC Platform;

•

the cost of manufacturing drug supply for our clinical and preclinical studies;

•

the future results of on-going preclinical research and subsequent clinical trials for treatments for oncology, genetic disease, liver disease, inflammation, and other pipeline candidates we may identify from time to time, including our ability to obtain regulatory approvals;

•

any changes in regulatory standards relating to the review of our product candidates; and our ability to timely obtain such required regulatory approvals;

•

the number and development requirements of other product candidates that we pursue;

•

the emergence of competing technologies and other adverse market developments;

•

our ability, and the ability of our third-party manufacturers, to manufacture or supply sufficient quantities of clinical products;

•

the costs of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities, for any of our product candidates for which we receive marketing approval;

•

our ability to achieve the degree of market acceptance necessary for future commercial success of our product candidates for which we receive marketing approval, if any;

•

the costs of preparing, filing, and prosecuting patent applications and maintaining, enforcing, and defending intellectual property-related claims;

•

the impact of litigation that may be brought against us or of litigation that we may pursue against others;

•

the extent to which we acquire or invest in businesses, products, and technologies;

•

our ability to successfully integrate acquired products and technologies into our business, including the possibility that the expected benefits of the transactions will not be fully realized by us or may take longer to realize than expected;

•

our ability to establish and maintain collaborations, partnerships or other similar arrangements and to obtain or satisfy any milestone, royalty, or other payments from any such collaborations;

•

the extent to which our business could be adversely impacted by the effects of COVID-19 outbreak, including due to actions by us, governments, suppliers or other third parties to control the spread of COVID-19, or by other health epidemics or pandemics; and

•

the costs of operating as a public company.

We have not been capitalized with sufficient funding to conduct our operations. We entered into the White Lion Purchase Agreement on November 3, 2022, as amended, whereby we have the right, but not the obligation, to require White Lion to purchase, from time to time, up to $100 million in aggregate gross purchase price of newly issued shares of our common stock. We expect to incur significant expenses and operating losses for the foreseeable future as we continue our efforts to identify product candidates and seek regulatory approvals within our gene therapy portfolio.

Additional financing will be needed to fund our ongoing activities. We may raise this additional funding through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions and funding under government contracts. We may be unable to raise additional funds or enter into such other arrangements or arrangement when needed on favorable terms, or at all. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate certain of our research and development programs. There can be no assurances that other sources of financing would be available. Due to these uncertainties, there is substantial doubt about our ability to continue as a going concern.

Our future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of additional financing; (ii) the success of our research and development programs; (iii) the development of competitive therapies by other biotechnology and pharmaceutical companies, (iv) our ability to attract and retain key employees, (v) our ability to manage growth of the organization; (vi) our ability to protect our proprietary technology; and ultimately (vii) regulatory approval and market acceptance of our product candidates.

Cash Flows Discussion

The following table summarizes our cash flows for the periods indicated:


	Six months ended June 30,
	2023			2022
Net cash used in operating activities	$	(2,673,507	)	$	(2,296,663	)
Net cash used in investing activities		—			(122,450	)
Net cash provided by financing activities		2,028,049			2,425,785
Net (decrease) increase in cash, cash equivalents and restricted cash	$	(645,458	)	$	6,672

Operating Activities

During the six months ended June 30, 2023, net cash used in operating activities was $2.7 million, due to our operating loss of $12.7 million, a change in the fair value of warrant liability of $0.2 million, a change in the fair value of derivative liability of $0.6 million and a loss on extinguishment of debt of $1 million, partially offset by non-cash items including impairment loss on operating right of use asset of $3.5 million, amortization of right-of-use asset of $0.2 million, issuance of shares for finance fee of $0.2 million, depreciation expense of $0.1 million and share-based compensation of $0.3 million, as well as a decrease in working capital of $2.9 million.

During the six months ended June 30, 2022, net cash used in operating activities was $2.3 million, due to our operating loss of $4.6 million, partially offset by amortization of right-of-use asset of $0.4 million, depreciation expense of $0.1 million, share-based compensation of $0.2 million and a decrease in working capital of $1.6 million.

Investing Activities

During the six months ended June 30, 2023, there was no net cash used in investing activities. During the six months ended June 30, 2022, net cash used in investing activities was $122,450 primarily due to capital expenditures for furniture and fixtures related to the office in South San Francisco, California.

Financing Activities

During the six months ended June 30, 2023 net cash provided by financing activities was driven by the net proceeds from issuance of convertible notes payable of $2.1 million, proceeds from exercise of warrants of $0.4 million and proceeds from a related party loan of $0.3 million, partially offset by repayment of the insurance financing of $0.7 million.

During the six months ended June 30, 2022, net cash provided by financing activities was driven by the net proceeds from pH Pharma Ltd of $1.3 million and proceeds from the issuance of common stock for $1.2 million.

Contractual Obligations and Commitments

In October 2021, we entered into a lease for laboratory and office facilities in Palo Alto, California that expires in March 2027 with a five-year renewal option and opened a secured letter of credit with a third-party financial institution in lieu of a security deposit for $177,000. Base rent for this lease is approximately $89,000 monthly with annual escalations of 3%. In March 2023, the Company vacated the premises and returned possession of the premises to the landlord in April 2023. The full amount of the security deposit has been applied to back rent and the Company is still responsible for the outstanding payments under the lease.

On March 1, 2022, we and pH Pharma Ltd entered into an administrative services and facilities agreement whereby pH Pharma Ltd will perform services, functions and responsibilities for us. Under the agreement, we paid pH Pharma Ltd $100,000 per month through August 30, 2022 and $15,000 from September 1, 2022 through February 28, 2023 based on the estimated value of the level of service to be performed. Additionally, we will pay pH Pharma Ltd $3,000 per month in lease payments. At June 30, 2023 we recorded a liability to accrued expenses of $342,248 related to this agreement.

Off-Balance Sheet Arrangements

We had no off-balance sheet arrangements as of June 30, 2023 and December 31, 2022.

Critical Accounting Policies and Significant Judgments and Estimates

The preparation of our unaudited interim condensed consolidated financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America and our discussion and

analysis of our financial condition and operating results require our management to make judgments, assumptions and estimates that affect the amounts reported. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods.

Our significant accounting policies and estimates are described in Note 2, “Summary of Significant Accounting Policies,” of the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the SEC on June 29, 2023, which describes the significant accounting policies and methods used in the preparation of our consolidated financial statements.

There have been no material changes to our critical accounting policies and estimates as from the date upon which we filed our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 with the SEC.

Recently Issued Accounting Standards

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements.

JOBS Act Accounting Election

We qualify as an “emerging growth company” as defined in the JOBS Act. An emerging growth company may take advantage of reduced reporting requirements that are not otherwise applicable to public companies. These provisions include, but are not limited to:

•

being permitted to present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations in this Form 10-Q;

•

not being required to comply with the auditor attestation requirements on the effectiveness of our internal controls over financial reporting;

•

not being required to comply with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis);

•

reduced disclosure obligations regarding executive compensation arrangements; 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.

We may use these provisions until the last day of our fiscal year in which the fifth anniversary of the completion of this offering occurs. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenue exceeds $1.235 billion, or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.

We have elected to take advantage of certain of the reduced disclosure obligations in this Form 10-Q and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our shareholders may be different than the information you receive from other public companies in which you hold stock.

The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards, until those standards apply to private companies. We have elected to take advantage of the benefits of this extended transition period and, therefore, we will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards. Until the date that we are no longer an emerging growth company or affirmatively and irrevocably opt out of the exemption provided by Section 7(a)(2)(B) of the Securities Act upon issuance of a new or revised accounting standard that applies to our financial statements and that has a different effective date for public and private companies, we will disclose the date on which we will adopt the recently issued accounting standard.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Effects of Inflation

Inflation generally affects us by increasing our cost of labor and research and development contracts. We do not believe that inflation has had a material effect on our financial results during the periods presented.

Concentration of Credit Risk

We received 100% of our revenue through a grant from a government organization during the three and six months ended June 30, 2023 and 2022. To date, no receivables have been written off.

Interest Rate Risk

As of June 30, 2023 and December 31, 2022, we had a cash balance of $0.2 million, $0.7 million, respectively, all of which were maintained in business checking accounts and money market accounts in the U.S. and South Korea. Our primary exposure to market risk is to interest income volatility, which is affected by changes in the general level of interest rates. As such rates are at a near record low, a 10% change in the market interest rates would not have a material effect on our business, financial condition or results of operations.

Foreign Currency Risk

We conduct our business in U.S. dollars and, thus, are not exposed to financial risks from exchange rate fluctuations between the U.S. dollar and other currencies.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2023. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, mean controls and other procedures of a company that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms. Disclosure controls include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2023, our chief executive officer and chief financial officer concluded that, as of such date, our internal controls over financial reporting were not effective as of the end of the period covered by this Interim Report on Form 10-Q due to material weaknesses as describe herein.

A material weakness is a control deficiency (within the meaning of the Public Company Accounting Oversight Board (United States) Auditing Standard No. 2) or combination of control deficiencies that result in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected. Management has identified the following material weaknesses:

•

Formal documentation of the Company’s internal control over financial reporting including risk assessments and processes needed to mitigate critical risks does not exist.

•

The Company lacks sufficient resources with respect to the number of people employed in its accounting department and the adequacy of their training in relation to its financial reporting requirements.

•

The Company’s internal control over financial reporting is ineffective with respect to its financial closing process in the following areas:

Preparation, review and approval of journal entries including the reasonableness of critical accounting estimates;

Completeness and proper cutoff of accrued liabilities including $1.4 million of unpaid compensation due to its former Chief Executive Officer under the terms of an executive employment agreement;

Timely closings as required to maintain compliance with reporting deadlines under applicable Securities and Exchange Commission regulations;

Evaluation of third party financial reporting advisors’ capabilities and the monitoring and evaluation of the accuracy and completeness of their work product.

•

The Company experienced difficulties in applying complex accounting principles including:

Financial instruments accounted for under ASC 480 and ASC 815-10;

Consolidation accounting following the completion of a reverse merger and recapitalization transaction;

Income taxes including the application of applicable foreign income tax regulations;

Debt extinguishment accounting including the settlement of a note payable to a related party and conversion of notes payable by a related party;

Fair value measurements.

Planned Remediation

Management continues to work to improve its controls related to our material weaknesses, specifically implementing improved processes and internal controls to ensure the proper application of accounting practices and guidance. We also intend to increase our accounting staff as soon as economically feasible and sustainable to remediate these material weaknesses. These material weaknesses will not be considered to be remediated until the applicable remediated controls are operating for a sufficient period of time and management has concluded that these controls are operating effectively.

Changes in Internal Control

Except as noted above, there has been no change in our internal control over financial reporting as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act during our most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

We are not currently a party to any material legal proceedings. At each reporting date, we evaluate whether a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. We expense the costs related to our legal proceedings as incurred.

Item 1A. Risk Factors.

In addition to the other information set forth in this report, you should carefully consider the risk factors discussed in Part I, Item 1A. “Risk Factors” in our Annual report on Form 10-K for the fiscal year ended December 31, 2022, which could materially affect our business, financial condition, or results of operations. There have been no material changes in or additions to the risk factors referred to in the previous sentence.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None

Item 3. Defaults Upon Senior Securities.

None

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

None.

Item 6. Exhibits.

Furnish the exhibits required by Item 601 of Regulation S-K (§ 229.601 of this chapter).


Exhibit Number		Description
10.1		Second Amendment to Common Stock Purchase Agreement, dated as of August14, 2023, by and between Peak Bio, Inc. and White Lion Capital LLC. (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on August 15, 2023).
31.1*		Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*		Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*		Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
32.2*		Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
101.INS		Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.
101.SCH		Inline XBRL Taxonomy Extension Schema Document
101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

* Filed herewith.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	PEAK BIO, INC.

Date: August 18, 2023	By:	/s/ Stephen LaMond
		Stephen LaMond
		Interim Chief Executive Officer and Director
		(principal executive officer)


Date: August 18, 2023	By:	/s/ Timothy Cunningham
		Timothy Cunningham
		Acting Chief Financial Officer


			(principal financial and accounting officer)