BNGO 10-Q

Bionano Genomics, Inc. (BNGO)

10-Q 2024-11-14 For: 2024-09-30

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Added on April 09, 2026

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Delaware						26-1756290
(State or Other Jurisdiction of Incorporation or Organization)						(I.R.S. Employer Identification No.)

9540 Towne Centre Drive, Suite 100, San Diego, CA						92121
(Address of Principal Executive Offices)						(Zip Code)



PART I. FINANCIAL INFORMATION		3
	Item 1. Financial Statements	3
	Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023 (Unaudited)	3
	Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2024 and 2023 (Unaudited)	4
	Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2024 and 2023 (Unaudited)	5
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and nine months ended September 30, 2024 and 2023 (Unaudited)	6
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024 and 2023 (Unaudited)	8
	Notes to Condensed Consolidated Financial Statements (Unaudited)	10
	Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	31
	Item 3. Quantitative and Qualitative Disclosures about Market Risk	44
	Item 4. Controls and Procedures	45
PART II. OTHER INFORMATION		47
	Item 1. Legal Proceedings	47
	Item 1A. Risk Factors	47
	Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	94
	Item 3. Defaults Upon Senior Securities	94
	Item 4. Mine Safety Disclosures	94
	Item 5. Other Information	94
	Item 6. Exhibits	95
SIGNATURES		97


	(Unaudited)
	September 30, 2024		December 31, 2023
Assets
Current assets:
Cash and cash equivalents	$	8,794,000	$	17,948,000
Investments	3,160,000		48,823,000
Accounts receivable, net	5,316,000		9,319,000
Inventory	14,323,000		22,892,000
Prepaid expenses and other current assets	4,387,000		6,019,000

Restricted investments	11,000,000		35,117,000
Total current assets	46,980,000		140,118,000
Restricted cash, net of current portion	400,000		400,000
Property and equipment, net	19,995,000		23,345,000
Operating lease right-of-use assets	2,833,000		5,633,000
Finance lease right-of-use assets	3,351,000		3,503,000
Intangible assets, net	11,045,000		33,974,000
Other long-term assets	2,758,000		7,431,000
Total assets	$	87,362,000	$	214,404,000

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	8,700,000		10,384,000
Accrued expenses	5,883,000		8,089,000
Contract liabilities	1,195,000		783,000
Operating lease liability	1,956,000		2,163,000
Finance lease liability	263,000		272,000

Purchase option liability (at fair value)	—		8,534,000
Convertible debentures and High Trail notes payable (at fair value)	14,953,000		69,803,000
Total current liabilities	32,950,000		100,028,000
Operating lease liability, net of current portion	1,730,000		3,590,000
Finance lease liability, net of current portion	3,551,000		3,585,000
Contingent consideration	—		10,890,000

Long-term contract liabilities	263,000		154,000
Total liabilities	$	38,494,000	$	118,247,000
Commitments and contingencies (Note 7)
Stockholders’ equity:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding at September 30, 2024 and December 31, 2023	—		—
Common stock, $0.0001 par value, 400,000,000 shares authorized at September 30, 2024 and December 31, 2023; 88,468,000 and 45,752,000 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	9,000		5,000
Additional paid-in capital	720,425,000		677,337,000
Accumulated deficit	(673,100,000)		(581,208,000)
Accumulated other comprehensive income	1,534,000		23,000
Total stockholders’ equity	$	48,868,000	$	96,157,000
Total liabilities and stockholders’ equity	$	87,362,000	$	214,404,000


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Revenue:
Product revenue	$	6,021,000	$	6,456,000	$	19,359,000	$	18,512,000
Service and other revenue	52,000		2,862,000		3,254,000		6,883,000
Total revenue	6,073,000		9,318,000		22,613,000		25,395,000
Cost of revenue:
Cost of product revenue	14,251,000		5,105,000		23,858,000		13,714,000
Cost of service and other revenue	268,000		1,464,000		1,792,000		4,553,000
Total cost of revenue	14,519,000		6,569,000		25,650,000		18,267,000
Operating expenses:
Research and development	4,717,000		13,785,000		21,329,000		42,331,000
Selling, general and administrative	9,464,000		24,896,000		40,109,000		77,809,000
Goodwill impairment	—		77,280,000		—		77,280,000
Intangible assets and other long-lived assets impairment	19,504,000		—		19,951,000		—
Restructuring costs	1,770,000		—		7,616,000		—
Total operating expenses	35,455,000		115,961,000		89,005,000		197,420,000
Loss from operations	(43,901,000)		(113,212,000)		(92,042,000)		(190,292,000)
Other income (expense):
Interest income	376,000		730,000		1,876,000		2,122,000




Other income (expense)	(697,000)		(45,000)		(1,694,000)		(334,000)
Total other income (expense)	(321,000)		685,000		182,000		1,788,000
Loss before income taxes	(44,222,000)		(112,527,000)		(91,860,000)		(188,504,000)
Provision for income taxes	(24,000)		(39,000)		(32,000)		(98,000)
Net loss	$	(44,246,000)	$	(112,566,000)	$	(91,892,000)	$	(188,602,000)
Net loss per share, basic and diluted	$	(0.52)	$	(3.22)	$	(1.34)	$	(5.85)
Weighted-average common shares outstanding basic and diluted	85,870,000		35,001,000		68,748,000		32,246,000


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Net loss:	$	(44,246,000)	$	(112,566,000)	$	(91,892,000)	$	(188,602,000)
Other comprehensive income (loss):
Unrealized gain on investment securities	10,000		227,000		12,000		1,014,000
Change in fair value attributable to instrument-specific credit risk	1,503,000		—		1,503,000		—
Foreign currency translation adjustments	24,000		(10,000)		(4,000)		17,000
Other comprehensive income	$	1,537,000	$	217,000	$	1,511,000	$	1,031,000
Total comprehensive loss	$	(42,709,000)	$	(112,349,000)	$	(90,381,000)	$	(187,571,000)


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


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


	Common Stock			Additional Paid-in Capital			Accumulated Deficit			Accumulated Other Comprehensive Income (Loss)			Total Stockholders’ Equity (Deficit)
	Shares	Amount

























Balance at January 1, 2023	29,718,000	$	3,000		$	599,234,000		$	(348,715,000)		$	(1,124,000)		$	249,398,000
Stock option exercises	4,000	—			23,000			—			—			23,000
Stock-based compensation expense	—	—			3,882,000			—			—			3,882,000
Issue common stock, net of issuance costs	950,000	—			14,848,000			—			—			14,848,000
Issuance of common stock due to the vesting of restricted stock units, net of shares withheld to cover taxes	7,000	—			—			—			—			—
Net loss	—	—			—			(37,124,000)			—			(37,124,000)
Other comprehensive income	—	—			—			—			459,000			459,000
Balance at March 31, 2023	30,679,000	$	3,000		$	617,987,000		$	(385,839,000)		$	(665,000)		$	231,486,000
Stock option exercises	—	—			1,000			—			—			1,000
Stock-based compensation expense	—	—			3,932,000			—			—			3,932,000
Issue common stock, net of issuance costs	2,552,000	—			17,802,000			—			—			17,802,000
Issuance of common stock due to the vesting of restricted stock units, net of shares withheld to cover taxes	(6,000)	—			—			—			—			—
Issue stock for employee stock purchase plan	15,000	—			92,000			—			—			92,000
Net loss	—	—			—			(38,912,000)			—			(38,912,000)
Other comprehensive income	—	—			—			—			355,000			355,000
Balance at June 30, 2023	33,240,000	$	3,000		$	639,814,000		$	(424,751,000)		$	(310,000)		$	214,756,000

Stock-based compensation expense	—	—			3,992,000			—			—			3,992,000
Issue common stock, net of issuance costs	2,109,000	—			12,661,000			—			—			12,661,000
Issue stock for warrant exercises	—	—			—			—			—			—
Issuance of common stock due to the vesting of restricted stock units, net of shares withheld to cover taxes	—	—			(61,000)			—			—			(61,000)
Net loss	—	—			—			(112,566,000)			—			(112,566,000)
Other comprehensive income	—	—			—			—			217,000			217,000
Balance at September 30, 2023	35,349,000	$	3,000		$	656,406,000		$	(537,317,000)		$	(93,000)		$	118,999,000

Balance at January 1, 2024	45,752,000	$	5,000		$	677,337,000		$	(581,208,000)		$	23,000		$	96,157,000

Stock-based compensation expense	—	—			3,015,000			—			—			3,015,000
Issue common stock, net of issuance costs	11,787,000	1,000			15,059,000			—			—			15,060,000




Net loss	—	—						(31,422,000)			—			(31,422,000)
Other comprehensive income (loss)	—	—									(39,000)			(39,000)
Balance at March 31, 2024	57,539,000	$	6,000		$	695,411,000		$	(612,630,000)		$	(16,000)		$	82,771,000
Stock-based compensation expense	—	—			2,583,000			—			—			2,583,000
Issue common stock, net of issuance costs	11,025,000	1,000			11,181,000			—			—			11,182,000


Issue stock for warrant exercises	2,197,000	—		2,000		—		—		2,000
Issue stock for employee stock purchase plan	15,000	—		10,000		—		—		10,000
Net loss	—	—		—		(16,224,000)		—		(16,224,000)
Other comprehensive income	—	—		—		—		13,000		13,000
Balance at June 30, 2024	70,776,000	$	7,000	$	709,187,000	$	(628,854,000)	$	(3,000)	$	80,337,000
Stock option exercises	—	—		—		—		—		—
Stock-based compensation expense	—	—		2,202,000		—		—		2,202,000
Issue common stock, net of issuance costs	11,865,000	1,000		9,034,000		—		—		9,035,000
Issue stock for warrant exercises	5,813,000	1,000		2,000		—		—		3,000
Issuance of common stock due to the vesting of restricted stock units, net of shares withheld to cover taxes	14,000	—		—		—		—		—
Net loss	—	—		—		(44,246,000)		—		(44,246,000)
Other comprehensive income	—	—		—		—		1,537,000		1,537,000
Balance at September 30, 2024	88,468,000	$	9,000	$	720,425,000	$	(673,100,000)	$	1,534,000	$	48,868,000


Payments of retirement fees for redemption of High Trail Notes	(5,375,000)		—
Net cash (used in)/provided by financing activities	(17,575,000)		45,331,000
Effect of exchange rates on cash, cash equivalents and restricted cash	(3,000)		17,000
Net decrease in cash, cash equivalents and restricted cash	(9,154,000)		29,477,000
Cash, cash equivalents and restricted cash at beginning of period	18,348,000		5,491,000
Cash, cash equivalents and restricted cash at end of period	$	9,194,000	$	34,968,000
Reconciliation of cash, cash equivalents and restricted cash reported within the unaudited condensed consolidated balance sheets to the total amounts reported on the unaudited condensed consolidated statements of cash flows
Cash and cash equivalents	8,794,000		34,568,000
Restricted cash	400,000		400,000
Total cash, cash equivalents and restricted cash at end of period	$	9,194,000	$	34,968,000
Supplemental cash flow disclosures:
Cash paid for interest	$	10,136,000	$	221,000
Cash paid for operating lease liabilities	$	2,126,000	$	1,938,000
Supplemental disclosure of non-cash investing and financing activities:

Transfer of instruments and servers from inventory to property and equipment, net	$	5,023,000	$	7,112,000
Property and equipment included in accounts payable	$	—	$	434,000


	September 30, 2024	September 30, 2023
Stock options	3,782,000	3,527,000
Warrants	65,456,000	40,000
Convertible debentures into common stock	8,500,000	—
RSUs	413,000	266,000
PSUs	29,000	29,000
Total	78,180,000	3,862,000


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Instruments	$	1,419,000	$	2,338,000	$	5,293,000	$	6,684,000
Consumables	3,333,000		2,476,000		9,366,000		7,664,000
Software	1,269,000		1,642,000		4,700,000		4,164,000
Total product revenue	6,021,000		6,456,000		19,359,000		18,512,000
Service and other	52,000		2,862,000		3,254,000		6,883,000
Total revenue	$	6,073,000	$	9,318,000	$	22,613,000	$	25,395,000


	September 30, 2024		December 31, 2023		December 31, 2022
Accounts receivable, net:
Accounts receivable, trade	$	5,520,000	$	9,802,000	$	7,315,000
Allowance for credit losses	(204,000)		(483,000)		(293,000)
	$	5,316,000	$	9,319,000	$	7,022,000


	Allowance for Credit Losses
Balance as of January 1, 2023	$	(293,000)
Provision for expected credit loss	(98,000)
Write-offs	37,000
Balance as of September 30, 2023	$	(354,000)

Balance as of January 1, 2024	$	(483,000)
Provision for expected credit loss	(9,000)
Write-offs	288,000
Balance as of September 30, 2024	$	(204,000)


	September 30, 2024		December 31, 2023
Inventory:
Raw materials	$	3,601,000	$	7,567,000
Work in process	3,583,000		9,790,000
Finished goods	9,097,000		10,245,000
	$	16,281,000	$	27,602,000
Inventories current	$	14,323,000	$	22,892,000
Inventories non-current (included in other long-term assets)	$	1,958,000	$	4,710,000


	Three Months Ended September 30,								Nine Months Ended September 30,
	2024				2023				2024				2023
	$		%		$		%		$		%		$		%
Americas	$	2,537,000	42	%	$	5,346,000	57	%	$	10,613,000	47	%	$	13,103,000	52	%
EMEA	2,764,000		46	%	2,686,000		29	%	9,521,000		42	%	8,426,000		33	%
Asia Pacific	772,000		13	%	1,286,000		14	%	2,479,000		11	%	3,866,000		15	%
Total	$	6,073,000	100	%	$	9,318,000	100	%	$	22,613,000	100	%	$	25,395,000	100	%


	September 30, 2024						December 31, 2023
	Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount		Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount
Trade name	$	1,000,000	$	(592,000)	$	408,000	$	2,630,000	$	(1,078,000)	$	1,552,000
Customer relationships	3,000,000		(1,775,000)		1,225,000		4,150,000		(2,002,000)		2,148,000
Developed technology	22,800,000		(13,490,000)		9,310,000		41,600,000		(11,428,000)		30,172,000
Intangibles, net	$	26,800,000	$	(15,857,000)	$	10,943,000	$	48,380,000	$	(14,508,000)	$	33,872,000


	September 30, 2024		December 31, 2023
Compensation expenses*	$	4,007,000	$	5,030,000
Customer deposits	17,000		17,000
Taxes payable	1,008,000		1,099,000
Insurance	16,000		512,000
Professional fees and royalties	496,000		387,000
Warranty liabilities	254,000		391,000
Accrued clinical study fees	10,000		138,000
Other	75,000		515,000
Total	$	5,883,000	$	8,089,000
*Compensation expenses include restructuring costs of $1.0 million as of September 30, 2024. Refer to Note 7 (Commitments and Contingencies).


2024	$	3,000,000
2025	12,000,000
2026	2,000,000
Total	$	17,000,000


	Debentures
Principal balance, January 1, 2024	$	—
Issuance of convertible debentures	20,000,000
Less:
Conversions	—
Redemption payments of principal	(3,000,000)
Debentures principal balance, September 30, 2024	$	17,000,000


Principal balance, January 1, 2024	$	61,000,000
Less:
Conversions	—
Partial redemption of principal	18,000,000
Redemption payment of principal	43,000,000
Total	$	—


	Shares of Stock under Warrants	Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term	Aggregate Intrinsic Value
Outstanding at January 1, 2024	21,696,000	$	4.38	4.78	$	—
Granted	51,770,000	0.56		—	—
Exercised	(8,010,000)	—		—	—
Canceled	—	—		—	—
Outstanding at September 30, 2024	65,456,000	$	1.89	1.94	$	—


	Shares of Stock under Stock Options	Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term	Aggregate Intrinsic Value
Outstanding at January 1, 2024	3,268,000	$	24.79	7.80	$	3,000
Granted	1,904,000	0.92		—
Exercised	—	—		—	—
Canceled	(1,390,000)	17.12		—
Outstanding and expected to vest at September 30, 2024	3,782,000	$	15.59	7.66	$	—
Vested and exercisable at September 30, 2024	1,729,000	$	25.72	6.42	$	—


	Stock Units	Weighted- Average Grant Date Fair Value per Share
Outstanding at January 1, 2024	239,000	$	16.30
Granted	407,000	0.93
Released	(69,000)	12.28
Forfeited	(164,000)	6.15
Outstanding at September 30, 2024	413,000	$	4.44


	Operating Leases		Finance Lease
Remainder of 2024	$	628,000	$	83,000
2025	2,608,000		338,000
2026	545,000		346,000
2027	254,000		356,000
2028	—		365,000
Thereafter	—		5,230,000
Total future lease payments	4,035,000		6,718,000
Less: imputed interest	(349,000)		(2,904,000)
Total lease liabilities	$	3,686,000	$	3,814,000


Accrued restructuring as of January 1, 2024	$	83,000
Restructuring charges incurred during the period	7,773,000
Cash payments	(6,828,000)
Accrued restructuring as of September 30, 2024	$	1,028,000


	September 30, 2024
	Total Fair Value and Carrying Value on Balance Sheet		Fair Value Measurement Category
			Level 1		Level 2		Level 3
Assets:


U.S. treasuries	3,160,000		—		3,160,000		—
Total investments:	$	3,160,000	$	—	$	3,160,000	$	—
Money market funds classified as cash equivalents	$	6,430,000	$	6,430,000	$	—	$	—

U.S. treasuries classified as restricted investments	11,000,000		—		11,000,000		—
Total restricted investments:	$	11,000,000	$	—	$	11,000,000	$	—

Liabilities:

Convertible notes payable	$	14,953,000	$	—	$	—	$	14,953,000


	September 30, 2024		December 31, 2023
Expected volatility	100.00	%	80.20	%
Risk-free interest rate	3.81	%	4.92	%
Term to maturity (years)	1.41		0.80
Debt discount rate	19.80	%	17.11	%
Equity discount rate	3.81	%	4.92	%


	September 30, 2024
Risk-free interest rate	4.33	%
Expected term to repayment (years)	0.50
Dissolution discount rate	21.19	%


	Subsequently Purchased Notes			Subsequently Purchased Warrants
		December 31, 2023			December 31, 2023
Expected volatility		80.20	%		66.20	%
Risk-free interest rate		4.46	%		3.80	%
Term to maturity (years)		1.50			5.00
Dividend yield		—	%		—	%
Exercise price		—			$3.19
Debt discount rate		16.60	%		—	%
Equity discount rate		4.46	%		—	%


	Contingent Consideration Liability (Level 3 Measurement)		Convertible Debentures Payable (Level 3 Measurement)		Convertible Notes Payable (Level 3 Measurement)		Option Liability (Level 3 Measurement)
Balance as of January 1, 2024	$	10,890,000	$	—	$	69,803,000	$	8,534,000
Issuance of convertible debentures payable, convertible notes payable and option	—		19,890,000		—		—
Change in estimated fair value, recorded in selling, general and administrative expenses	(10,890,000)		—		—		—
Change in estimated fair value, recorded in other income (expense), net	—		(434,000)		(4,524,000)		(3,474,000)
Change in fair value attributable to instrument-specific credit risk recorded in other comprehensive income (loss)	—		(1,503,000)		—		—

Cash payments	—		—		(61,000,000)		—
Cash payments on redemptions	—		(3,000,000)		(5,374,000)
(Gain)/loss on extinguishment of High Trail	—		—		1,095,000		(5,060,000)
Balance as of September 30, 2024	$	—	$	14,953,000	$	—	$	—


	Contingent Consideration Liability (Level 3 Measurement)
Balance as of January 1, 2023	$	22,352,000

Change in estimated fair value, recorded in selling, general and administrative expenses	2,528,000

Balance as of September 30, 2023	$	24,880,000


	Remaining Contractual Maturity (in years)	Amortized Cost		Unrealized Gains		Unrealized Losses		Aggregate Estimated Fair Value


U.S. treasuries	Less than 1	3,160,000		—		—		3,160,000
Total maturity less than 1 year		$	3,160,000	$	—	$	—	$	3,160,000


	Less Than 12 Months				12 Months or Greater				Total
	Fair Value		Gross Unrealized Loss		Fair Value		Gross Unrealized Loss		Fair Value		Gross Unrealized Loss


U.S. treasuries	3,160,000		—		—		—		3,160,000		—
Total	$	3,160,000	$	—	$	—	$	—	$	3,160,000	$	—


	Three Months Ended September 30,				Period-to-Period Change
	2024		2023		$		%
Revenues:
Product revenue	$	6,021,000	$	6,456,000	$	(435,000)	(7)	%
Service and other revenue	52,000		2,862,000		(2,810,000)		(98)	%
Total revenue	6,073,000		9,318,000		(3,245,000)		(35)	%
Cost of revenue:
Cost of product revenue	14,251,000		5,105,000		9,146,000		179	%
Cost of service and other revenue	268,000		1,464,000		(1,196,000)		(82)	%
Total cost of revenue	14,519,000		6,569,000		7,950,000		121	%
Operating expenses:
Research and development	4,717,000		13,785,000		(9,068,000)		(66)	%
Selling, general and administrative	9,464,000		24,896,000		(15,432,000)		(62)	%
Goodwill impairment	—		77,280,000		(77,280,000)		(100)	%
Intangible assets and other long-lived assets impairment	19,504,000		—		19,504,000		100	%
Restructuring costs	1,770,000		—		1,770,000		100	%
Total operating expenses	35,455,000		115,961,000		(80,506,000)		(69)	%
Loss from operations	(43,901,000)		(113,212,000)		69,311,000		(61)	%
Other income (expenses):
Interest income	376,000		730,000		(354,000)		(48)	%




Other income (expenses)	(697,000)		(45,000)		(652,000)		1,449	%
Total other income (expenses)	(321,000)		685,000		(1,006,000)		(147)	%
Loss before income taxes	(44,222,000)		(112,527,000)		68,305,000		(61)	%
Provision for income taxes	(24,000)		(39,000)		15,000		(38)	%
Net loss	$	(44,246,000)	$	(112,566,000)	$	68,320,000	(61)	%


	Three Months Ended September 30,						Period-to-Period Change		Period-to-Period Percentage Change
	2024			2023			2024 to 2023		2024 to 2023
Gross profit (loss):
Product	$	(8,230,000)		$	1,351,000		$	(9,581,000)	(709)%
Service and other	(216,000)			1,398,000			(1,614,000)		(115)%
Total gross profit	$	(8,446,000)		$	2,749,000		$	(11,195,000)	(407)%

Gross margin:
Product	(137)		%	21		%
Service and other	(415)		%	49		%
Total gross margin	(139)		%	30		%


Net cash provided by (used in):	Nine Months Ended September 30,
	2024		2023

Operating activities	$	(62,418,000)	$	(95,402,000)
Investing activities	70,842,000		79,531,000
Financing activities	(17,575,000)		45,331,000


Exhibit Number						Description

3.1						Amended and Restated Certificate of Incorporation, as amended (incorporated by reference to Exhibit 3.1 to Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on November 8, 2023.
3.2						Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on August 24, 2018).
3.3						Amendment to Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on April 14, 2023).
4.1						Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-225970), as amended, originally filed with the SEC on June 28, 2018).
4.2						Form of Warrant to Purchase Series D-1 Preferred Stock issued to Midcap Financial Trust (incorporated by reference to Exhibit 4.8 to the Registrant’s Registration Statement on Form S-1 (File No. 333-225970), as amended, originally filed with the SEC on June 28, 2018).
4.3						Form of Warrant to Purchase Common Stock for Service Providers (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on November 21, 2018).
4.4						Form of Warrant to Purchase Common Stock issued to Investors in October 2019 Public Offering (incorporated by reference to Exhibit 4.13 to the Registrant’s Registration Statement on Form S-1 (File No. 333-233828), as amended, originally filed with the SEC on September 18, 2019).
4.5						Form of Warrant to Purchase Common Stock issued to Investors in April 2020 Public Offering) (incorporated by reference to Exhibit 4.16 to the Registrant’s Registration Statement on Form S-1 (File No. 333-237074), as amended, originally filed with the SEC on March 11, 2020).
4.6						Form of Warrant to Purchase Common Stock issued to Purchaser in October 2023 Offering (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on October 11, 2023).
4.7						Form of Warrant to Purchase Common Stock issued to Investors in April 2024 Registered Direct Offering) (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on April 5, 2024).
4.8						Form of Warrant to Purchase Common Stock issued to Investors in April 2024 Registered Direct Offering ) (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on April 5, 2024).
4.9^+						Form of Senior Secured Convertible Debenture Due May 24, 2026 (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on May 28, 2024)
4.10						Form of Pre-Funded Warrant to Purchase Common Stock issued to Investors in July 2024 Registered Direct Offering (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on July 8, 2024).
4.11						Form of Warrant to Purchase Series A Common Stock issued to Investors in July 2024 Registered Direct Offering (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on July 8, 2024).
4.12						Form of Warrant to Purchase Series B Common Stock issued to Investors in July 2024 Registered Direct Offering (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K, filed with the SEC on July 8, 2024).
4.13						Form of Warrant to Purchase Series C Common Stock issued to Investors in October 2024 Registered Direct Offering (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on October 31, 2024).
4.14						Form of Warrant to Purchase Series D Common Stock issued to Investors in October 2024 Registered Direct Offering (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on October 31, 2024).
10.1^+						Form of Securities Purchase Agreement, dated July 4, 2024, by and among the Company and the Purchasers named therein (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on July 8, 2024).
10.2^+						Form of Securities Purchase Agreement, dated April 4, 2024, by and among the Company and the Purchasers named therein (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on April 5, 2024).













31.1						Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
31.2						Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
32.1*						Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS						Inline XBRL Instance Document—the instance document does not appear in the Interactive Data File as its 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 (formatted in Inline XBRL and contained in Exhibit 101)