Cartesian Therapeutics, Inc 10-K for FY2019

About this 10-K

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Cartesian Therapeutics, Inc. (RNAC)

10-K 2020-03-12 For: 2019-12-31

Added on April 08, 2026

Cartesian Therapeutics, Inc filed this 10-K on March 12, 2020, covering the fiscal year ended December 31, 2019 (FY2019).

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

Fiscal year ended December 31, 2019, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $6.68M; up 639.4% from $903K a year earlier
Net loss: $55.35M; compared with a net loss of $65.34M a year earlier

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Delaware			26-1622110
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)

480 Arsenal Way	Watertown	MA	02472
(Address of principal executive offices)			(Zip Code)



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, $0.0001 par value per share	SELB	The Nasdaq Global Market



TABLE OF CONTENTS

	Part I

Item 1.	Business	3
Item 1A.	Risk Factors	33
Item 1B.	Unresolved Staff Comments	70
Item 2.	Properties	70
Item 3.	Legal Proceedings	70
Item 4.	Mine Safety Disclosures	70

	Part II

Item 5.	Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	74
Item 6.	Selected Consolidated Financial Data	75
Item 7.	Management's Discussion and Analysis of Financial Condition and Results of Operations	76
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	87
Item 8.	Financial Statements and Supplementary Data	87
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	87
Item 9A.	Controls and Procedures	87
Item 9B.	Other Information	88

	Part III

Item 10.	Directors, Executive Officers and Corporate Governance	89
Item 11.	Executive Compensation	89
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	89
Item 13.	Certain Relationships and Related Transactions, and Director Independence	89
Item 14.	Principal Accountant Fees and Services	89

	Part IV

Item 15.	Exhibits and Financial Statement Schedules	90
Item 16.	Form 10-K Summary	95
	Signatures	96



	Year Ended December 31,
(In thousands, except share and per share data)	2019			2018			2017			2016			2015
Consolidated Statement of Operations Data
Grant and collaboration revenue	$	6,677		$	903		$	207		$	8,083		$	6,011
Operating expenses	59,132			65,925			63,991			42,753			31,315
Loss from operations	(52,455		)	(65,022		)	(63,784		)	(34,670		)	(25,304		)
Loss on extinguishment of debt	—			—			(673		)	—			—
Change in fair value of warrant liabilities	(857		)	—			—			—			—
Other income (expense), net	(2,038		)	(314		)	(864		)	(1,540		)	130
Net loss	$	(55,350	)	$	(65,336	)	$	(65,321	)	$	(36,210	)	$	(25,174	)
Net loss per share:
Basic and diluted	$	(1.22	)	$	(2.92	)	$	(3.20	)	$	(3.89	)	$	(15.13	)
Weighted average common shares outstanding:
Basic and diluted	45,548,511			22,389,286			20,425,050			10,493,939			2,150,422

	As of December 31,
(In thousands)	2019			2018			2017			2016			2015
Consolidated Balance Sheet Data
Cash, cash equivalents, short-term deposits and investments	$	89,893		$	37,403		$	96,562		$	84,141		$	36,462
Total assets	$	99,569		$	44,482		$	101,100		$	89,301		$	42,824
Loans payable	$	18,905		$	21,385		$	21,042		$	12,044		$	11,855
Warrant liabilities	$	41,549		$	—		$	—		$	—		$	—
Redeemable convertible preferred stock	$	—		$	—		$	—		$	—		$	137,482
Total stockholders' equity (deficit)	$	8,397		$	(5,418	)	$	51,814		$	54,957		$	(116,493	)



☒	ANNUAL 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


-	our status as a development-stage company and our expectation to incur losses in the future;


-	our ability to continue as a going concern, our future capital needs and our need to raise additional funds;


-	our ability to build a pipeline of product candidates and develop and commercialize drugs;


-	our ability to enroll patients in clinical trials, timely and successfully complete those trials and receive necessary regulatory approvals;


-	our ability to have continued access to manufacturing facilities and to receive or manufacture sufficient quantities of our product candidates;


-	our ability to maintain our existing or future collaborations or licenses, including our ability to reach an agreement regarding an acceptable amendment of our exclusive patent license agreement with the Massachusetts Institute of Technology;


-	our ability to protect and enforce our intellectual property rights;


-	federal, state, and foreign regulatory requirements, including FDA regulation of our product candidates;


-	our unproven approach to therapeutic intervention;


-	our ability to obtain and retain key executives and attract and retain qualified personnel;


-	developments relating to our competitors and our industry, including the impact of government regulation; and


•	Selectively pursue licensing opportunities and maximize the value of our ImmTOR programs for immune tolerance. In addition to our own product development efforts and those on which we are collaborating, we are in discussions with potential licensees to pursue novel therapies that would utilize our ImmTOR platform. For example,


•	combination with a uricase enzyme for the treatment of chronic refractory gout;


•	combination with gene therapies for the treatment of rare diseases;


•	potential application with other marketed products, product candidates in development and novel biologic drugs that would otherwise be too immunogenic to develop


•	methods and compositions incorporating our proprietary nanoparticles in a variety of tolerance applications, including:


•	mitigating or treating anti-drug antibodies associated with protein drugs, such as for chronic refractory gout, covering ImmTOR co-administered with pegadricase, which related patents are expected to expire between 2032 and 2038, and


•	genetic therapies (such as viral delivery of genes), covering ImmTOR co-administered with a viral vector, which related patents are expected to expire between 2032 and 2039; and


•	development and commercialization of SEL-212, including both composition of matter and method of treatment claims (there are multiple patent families that cover the SEL-212 product, one of which is a licensed, issued U.S. patent that covers the SEL-212 product, which expires in 2021).


•	completion of extensive nonclinical testing, sometimes referred to as preclinical testing, including laboratory tests, animal trials and formulation studies in accordance with applicable regulations, including good laboratory practices, or GLPs, and applicable requirements for humane use of laboratory animals;


•	submission to the FDA of an IND, which must become effective before human clinical trials may begin;


•	performance of adequate and well-controlled human clinical trials according to good clinical practice, or GCP, regulations and any additional requirements for the protection of human research subjects and their health information, to establish the safety, purity and potency of the proposed biological product for its intended use;


•	submission to the FDA of a BLA for marketing approval that includes substantive evidence of safety, purity, and potency from results of nonclinical testing and clinical trials;


•	satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity;


•	potential FDA audit of the nonclinical and clinical study sites that generated the data in support of the BLA; and


•	Phase I. The biological product candidate is initially introduced into healthy human patients and tested for safety. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.


•	Phase II. The biological product candidate is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.


•	Phase III. Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population at geographically dispersed clinical study sites. These clinical trials are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling.


•	The Community MA, which is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, and which is valid throughout the entire territory of the EEA. The Centralized Procedure is mandatory for


•	second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior;


•	applicant consents to a second orphan medicinal product application; or


-	conduct additional clinical trials of SEL‑212, our lead product candidate;