Bicycle Therapeutics PLC 10-Q for FY2023 Q3

Bicycle Therapeutics PLC (BCYC)

10-Q 2023-11-02 For: 2023-09-30

Added on April 06, 2026

About this 10-Q

Bicycle Therapeutics PLC filed this 10-Q on November 2, 2023, covering the quarter ended September 30, 2023 (FY2023 Q3).

Headline figures

Quarter ended September 30, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $5.35M; up 76.1% from $3.04M a year earlier
Net loss: $49.9M; compared with a net loss of $28.35M a year earlier
Diluted EPS: -$1.26; compared with -$0.96 a year earlier

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England and Wales		Not Applicable
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

Blocks A & B, Portway Building, Granta Park Great Abington, Cambridge, United Kingdom		CB21 6GS
(Address of principal executive offices)		(Zip Code)


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Ordinary shares, nominal value £0.01 per share*	n/a	The Nasdaq Stock Market LLC
American Depositary Shares, each representing one ordinary share, nominal value £0.01 per share	BCYC	The Nasdaq Stock Market LLC


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


		Page
PART I - FINANCIAL INFORMATION		1

Item 1.	Financial Statements (unaudited)	1
	Condensed Consolidated Balance Sheets	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss	2
	Condensed Consolidated Statements of Shareholders’ Equity	3
	Condensed Consolidated Statements of Cash Flows	5
	Notes to Condensed Consolidated Financial Statements	6

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	38

Item 3.	Quantitative and Qualitative Disclosure About Market Risk	54

Item 4.	Controls and Procedures	55

PART II - OTHER INFORMATION		55

Item 1.	Legal Proceedings	55

Item 1A.	Risk Factors	56

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	113

Item 3.	Defaults Upon Senior Securities	113

Item 4.	Mine Safety Disclosures	113

Item 5.	Other Information	113

Item 6.	Exhibits	114

SIGNATURES


	September 30,		December 31,
	2023		2022
Assets
Current assets:
Cash and cash equivalents	$	572,086	$	339,154
Accounts receivable		—		2,045
Prepaid expenses and other current assets		13,673		9,022
Research and development incentives receivable		17,277		19,162
Total current assets		603,036		369,383
Property and equipment, net		15,599		19,110
Operating lease right-of-use assets		14,597		13,658
Other assets		5,451		8,458
Total assets	$	638,683	$	410,609
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable	$	8,493	$	6,472
Accrued expenses and other current liabilities		34,053		26,452
Deferred revenue, current portion		27,190		20,418
Total current liabilities		69,736		53,342
Long-term debt, net of discount		30,604		30,315
Operating lease liabilities, net of current portion		10,423		10,885
Deferred revenue, net of current portion		107,582		41,455
Other long‑term liabilities		4,316		3,829
Total liabilities		222,661		139,826
Commitments and contingencies (Note 11)
Shareholders’ equity:
Ordinary shares, including non-voting ordinary shares, £0.01 nominal value; 59,612,613 and 57,820,181 shares authorized at September 30, 2023 and December 31, 2022, respectively; 42,384,799 and 29,873,893 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively		550		387
Additional paid-in capital		875,248		601,105
Accumulated other comprehensive income		2,885		387
Accumulated deficit		(462,661)		(331,096)
Total shareholders’ equity		416,022		270,783
Total liabilities and shareholders’ equity	$	638,683	$	410,609


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
Collaboration revenues	$	5,352	$	3,040	$	21,645	$	11,278
Operating expenses:
Research and development		39,868		22,752		111,799		56,890
General and administrative		16,281		10,047		45,557		38,830
Total operating expenses		56,149		32,799		157,356		95,720
Loss from operations		(50,797)		(29,759)		(135,711)		(84,442)
Other income (expense):
Interest income		3,985		1,991		7,726		3,117
Interest expense		(814)		(817)		(2,443)		(2,518)
Total other income (expense), net		3,171		1,174		5,283		599
Net loss before income tax provision		(47,626)		(28,585)		(130,428)		(83,843)
Provision for (benefit from) income taxes		2,272		(238)		1,137		(1,104)
Net loss	$	(49,898)	$	(28,347)	$	(131,565)	$	(82,739)
Net loss per share, basic and diluted	$	(1.26)	$	(0.96)	$	(3.95)	$	(2.79)
Weighted average ordinary shares outstanding, basic and diluted		39,576,467		29,676,021		33,291,701		29,643,502

Comprehensives loss:
Net loss	$	(49,898)	$	(28,347)	$	(131,565)	$	(82,739)
Other comprehensive income:
Foreign currency translation adjustment		3,762		902		2,498		3,916
Total comprehensive loss	$	(46,136)	$	(27,445)	$	(129,067)	$	(78,823)


						Accumulated
				Additional		Other				Total
	Ordinary Shares			Paid‑in		Comprehensive		Accumulated		Shareholders’
	Shares	Amount		Capital		Income (Loss)		Deficit		Equity
Balance at December 31, 2022	29,873,893	$	387	$	601,105	$	387	$	(331,096)	$	270,783
Issuance of ADSs upon exercise of share options	877		—		1		—		—		1
Issuance of ADSs, net of commissions and offering expenses of $0.1 million	100,000		1		2,715		—		—		2,716
Issuance of ADSs upon vesting of restricted share units	56,988		1		—		—		—		1
Share-based compensation expense	—		—		9,042		—		—		9,042
Foreign currency translation adjustment	—		—		—		(316)		—		(316)
Net loss	—		—		—		—		(39,064)		(39,064)
Balance at March 31, 2023	30,031,758		389		612,863		71		(370,160)		243,163
Issuance of ADSs upon exercise of share options	12,389		—		165		—		—		165
Issuance of ADSs, net of commissions and offering expenses of $0.4 million	520,000		7		12,120		—		—		12,127
Issuance of ADSs upon vesting of restricted share units	21,793		—		—		—		—		—
Share-based compensation expense	—		—		8,193		—		—		8,193
Foreign currency translation adjustment	—		—		—		(948)		—		(948)
Net loss	—		—		—		—		(42,603)		(42,603)
Balance at June 30, 2023	30,585,940		396		633,341		(877)		(412,763)		220,097
Issuance of ADSs upon exercise of share options	13,296		—		139		—		—		139
Issuance of ADSs and non-voting ordinary shares, net of commissions and offering expenses of $15.5 million	11,764,706		154		234,338		—		—		234,492
Issuance of ADSs upon vesting of restricted share units	20,857		—		—		—		—		—
Share-based compensation expense	—		—		7,430		—		—		7,430
Foreign currency translation adjustment	—		—		—		3,762		—		3,762
Net loss	—		—		—		—		(49,898)		(49,898)
Balance at September 30, 2023	42,384,799	$	550	$	875,248	$	2,885	$	(462,661)	$	416,022


	Nine Months Ended
	Ended
	September 30,
	2023		2022
Cash flows from operating activities:
Net loss	$	(131,565)	$	(82,739)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation expense		24,665		21,239
Depreciation and amortization		4,892		2,303
Non-cash interest		289		359
Deferred income tax provision (benefit)		3,588		(2,640)
Changes in operating assets and liabilities:
Accounts receivable		2,482		348
Research and development incentives receivable		2,192		(3,064)
Prepaid expenses and other assets		(4,615)		(2,137)
Operating lease right‑of‑use assets		3,116		2,015
Accounts payable		3,835		4,931
Accrued expenses and other current liabilities		6,084		5,495
Operating lease liabilities		(2,983)		(1,446)
Deferred revenue		74,238		(969)
Other long-term liabilities		442		503
Net cash used in operating activities		(13,340)		(55,802)
Cash flows from investing activities:
Purchases of property and equipment		(2,878)		(17,539)
Net cash used in investing activities		(2,878)		(17,539)
Cash flows from financing activities:
Proceeds from the issuance of ADSs and non-voting ordinary shares, net of issuance costs		249,335		—
Proceeds from the exercise of share options and sale of ordinary shares		306		804
Net cash provided by financing activities		249,641		804
Effect of exchange rate changes on cash, cash equivalents and restricted cash		57		(4,674)
Net increase (decrease) in cash, cash equivalents and restricted cash		233,480		(77,211)
Cash, cash equivalents and restricted cash at beginning of period		339,154		438,680
Cash, cash equivalents and restricted cash at end of period	$	572,634	$	361,469
Reconciliation of cash, cash equivalents and restricted cash
Cash and cash equivalents	$	572,086	$	361,469
Restricted cash included in other assets		548		—
Total cash, cash equivalents and restricted cash	$	572,634	$	361,469
Supplemental disclosure of cash flow information
Cash paid for interest	$	2,059	$	2,099
Cash paid for income taxes	$	664	$	1,203
Cash paid for amounts included in the measurement of operating lease liabilities	$	4,188	$	2,245
Changes in purchases of property and equipment in accounts payable and accrued expenses	$	(1,689)	$	318
Non-cash impact right-of-use asset and operating lease liabilities	$	3,898	$	3,120


Year Ending December 31,
2023	$	—
2024		—
2025		31,500
Total	$	31,500


	Number of			Weighted
	Shares	Weighted		Average	Aggregate
	Underlying	Average		Contractual	Intrinsic
	Share Options	Exercise Price		Term	Value
				(in years)	(in thousands)
Outstanding as of December 31, 2022	5,898,888	$	22.45	7.64	$	71,002
Granted	1,859,315		27.57	—		—
Exercised	(26,562)		11.42	—		—
Forfeited	(419,621)		30.69	—		—
Outstanding as of September 30, 2023	7,312,020	$	23.32	6.99	$	29,629
Vested and expected to vest as of September 30, 2023	7,312,020	$	23.32	6.99	$	29,629
Options exercisable as of September 30, 2023	4,334,755	$	18.39	5.75	$	28,069


	Number of Shares	Weighted-Average
	Underlying RSUs	Grant Date Fair Value
Unvested at December 31, 2022	187,725	$	60.86
Granted	321,839		29.59
Vested	(99,638)		51.39
Forfeited	(74,822)		39.55
Unvested at September 30, 2023	335,104	$	38.40


	Three Months				Nine Months
	Ended				Ended
	September 30,				September 30,
	2023		2022		2023		2022
Collaboration revenues
Bayer	$	434	$	—	$	434	$	—
Novartis		772		—		772		—
Ionis		2,782		2,195		8,123		6,764
Genentech		1,364		798		11,112		3,144
Dementia Discovery Fund		—		47		—		205
AstraZeneca		—		—		1,204		1,165
Total collaboration revenues	$	5,352	$	3,040	$	21,645	$	11,278


	Allocation of
Performance Obligations	Transaction Price
Two combined performance obligations related to the licenses and research and development services associated with radiopharmaceutical compounds directed to the first and second targets	$	14,976
Material right associated with limited substitution rights for either the first or second target		1,527
Two material rights associated with the option to progress radiopharmaceutical candidates directed to the first and second targets into further development		14,691
Two material rights associated with the option to progress a non-radiopharmaceutical compound directed to the first and second targets		8,703
Material right for the option to expand the collaboration to include a third target and the underlying additional option rights		7,603
	$	47,500


	Beginning Balance						Impact of		Ending Balance
	January 1,						Exchange		September 30,
	2023		Additions		Deductions		Rates		2023
Contract liabilities:
Deferred revenue
Bayer collaboration deferred revenue	$	—	$	45,000	$	(434)	$	(2,045)	$	42,521
Novartis collaboration deferred revenue		—		50,000		(772)		(178)		49,050
Ionis collaboration deferred revenue		21,489		870		(8,123)		227		14,463
Genentech collaboration deferred revenue		39,308		—		(11,112)		542		28,738
AstraZeneca collaboration deferred revenue		1,076		—		(1,204)		128		—
Total deferred revenue	$	61,873	$	95,870	$	(21,645)	$	(1,326)	$	134,772


Year Ending December 31,
2023		1,394
2024		5,654
2025		5,740
2026		3,271
2027		821
Present value adjustment		(1,796)
Total lease liabilities		15,084
Less: current lease liabilities		(4,661)
Long term lease liabilities	$	10,423


	September 30,		December 31,
	2023		2022
Laboratory equipment	$	15,087	$	14,872
Leasehold improvements		10,547		10,736
Computer equipment and software		537		441
Furniture and office equipment		823		924
		26,994		26,973
Less: Accumulated depreciation and amortization		(11,395)		(7,863)
	$	15,599	$	19,110


	Three Months Ended September 30,
	2023		2022		Change

	(in thousands)
BT8009 (Nectin‑4)	$	11,806	$	2,757	$	9,049
BT5528 (EphA2)		2,149		3,460		(1,311)
BT1718 (MT1)		147		142		5
Bicycle tumor-targeted immune cell agonists		4,717		3,790		927
Other discovery and platform related expense		9,464		6,504		2,960
Employee and contractor related expenses		11,793		8,275		3,518
Share-based compensation		3,357		2,637		720
Facility expenses		1,697		1,339		358
Research and development incentives and government grants		(5,262)		(6,152)		890
Total research and development expenses	$	39,868	$	22,752	$	17,116


	Nine Months Ended September 30,
	2023		2022		Change

	(in thousands)
Collaboration revenues	$	21,645	$	11,278	$	10,367
Operating expenses:
Research and development		111,799		56,890		54,909
General and administrative		45,557		38,830		6,727
Total operating expenses		157,356		95,720		61,636
Loss from operations		(135,711)		(84,442)		(51,269)
Other income (expense):
Interest income		7,726		3,117		4,609
Interest expense		(2,443)		(2,518)		75
Total other income (expense), net		5,283		599		4,684
Net loss before income tax provision		(130,428)		(83,843)		(46,585)
Provision for (benefit from) income taxes		1,137		(1,104)		2,241
Net loss	$	(131,565)	$	(82,739)	$	(48,826)


	Payments due by period
			Less than
	Total		1 year		1 to 3 years		3 years to 5 years

	(in thousands)
Operating lease commitments⁽¹⁾	$	16,880	$	5,633	$	10,228	$	1,019
Debt obligations⁽²⁾		35,978		2,534		33,444		—
Total	$	52,858	$	8,167	$	43,672	$	1,019


Exhibit Number		Description

3.1		Articles of Association (incorporated by reference to Exhibit 3.2 to Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-231076), filed with the Securities and Exchange Commission on May 13, 2019).

10.1*+		Amendment No.1 to Service Agreement, dated July 24, 2023, by and between BicycleTx Limited and Kevin Lee.

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 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.

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104		Cover Page Interactive Data File – the cover page XBRL tags are embedded within the Inline XBRL document (included in Exhibit 101)


	BICYCLE THERAPEUTICS PLC

Date: November 2, 2023	By:	/s/ Kevin Lee
		Kevin Lee, Ph.D., MBA
		Chief Executive Officer
		(Principal Executive Officer)

Date: November 2, 2023	By:	/s/ Alethia Young
		Alethia Young
		Chief Financial Officer
		(Principal Financial Officer)


Date: November 2, 2023	By:	/s/ Kevin Lee
		Kevin Lee, Ph.D., MBA
		Chief Executive Officer (Principal Executive Officer)


Date: November 2, 2023	By:	/s/ Alethia Young
		Alethia Young
		Chief Financial Officer (Principal Financial Officer)