SEC Filing | Enliven Therapeutics

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

View:

Download DOC

Download PDF

Download XLS

Download XBRL

imra-10q_20210630.htm

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, 2021

☐	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: 001-39247

IMARA INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	81-1523849
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
116 Huntington Avenue, 6^th Floor Boston, Massachusetts	02116
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (617) 206-2020

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 $0.001 per share

IMRA

The Nasdaq Stock Market LLC

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, a 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.

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 2, 2021, the registrant had 26,247,270 shares of common stock, $0.001 par value per share, outstanding.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things:

•

the impact of the ongoing COVID-19 pandemic and our response to it;

•

the initiation, timing, progress and results of our current and future preclinical studies and clinical trials, including our ongoing Ardent and Forte Phase 2b clinical trials of IMR-687 (tovinontrine) in sickle cell disease, or SCD, and ß-thalassemia, our open label extension clinical trial of IMR-687 in SCD and our potential clinical development of IMR-687 in heart failure with preserved ejection fraction;

•

our estimates regarding expenses, future revenue, timing of any future revenue, capital requirements and need for additional financing;

•

our plans to develop and, if approved, subsequently commercialize IMR-687 and any other product candidates, including in combination with other drugs and therapies;

•

the timing of and our ability to submit applications for, obtain and maintain regulatory approvals for IMR-687 and any other product candidates we may identify and pursue;

•

our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash, cash equivalents and investments;

•

the potential advantages or differentiating features of IMR-687 and any other product candidates we may identify and pursue;

•

the rate and degree of market acceptance and clinical utility of IMR-687 and any other product candidates we may identify and pursue;

•

our estimates regarding the potential market opportunity for IMR-687 and any other product candidates we may identify and pursue;

•

our commercialization, marketing and manufacturing capabilities and strategy;

•

our expectations regarding our ability to obtain and maintain intellectual property protection for IMR-687 and any other product candidates we may identify and pursue;

•

our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;

•

the impact of government laws and regulations;

•

our competitive position and expectations regarding developments and projections relating to our competitors and any competing therapies that are or become available;

•

our ability to maintain and establish collaborations or obtain additional funding; and

•

our expectations regarding the time during which we will be an emerging growth company under the JOBS Act.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.

We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q, particularly in the "Risk Factors" section, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make.

You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly Report on Form 10-Q, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

RISK FACTOR SUMMARY

Our business is subject to a number of risks that if realized could materially affect our business, financial condition, results of operations, cash flows and access to liquidity. These risks are discussed more fully in Part I, Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q. Our principal risks include the following:

•

We have incurred significant losses since our inception, and we expect to incur losses over the next several years.

•

We are heavily dependent on the success of our sole product candidate, IMR-687. If we are unable to successfully complete clinical development, obtain regulatory approval for, and commercialize IMR-687, or experience delays in doing so, our business will be materially harmed.

•

We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

•

Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

•

Our business and operations have been and may continue to be adversely affected by the ongoing COVID-19 pandemic as may the operations of our suppliers and manufacturers and other third-party service providers.

•

Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of any product candidates.

•

Because we are developing IMR-687 using surrogate endpoints, the FDA or other regulatory authorities may not consider the endpoints of our clinical trials to predict or provide clinically meaningful results.

•

We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

•

If we fail to comply with our obligations under our existing license agreement with H. Lundbeck A/S, or under any future intellectual property licenses, or otherwise experience disruptions to our business relationships with our current or any future licensors, we could lose intellectual property rights that are important to our business.

•

If we are unable to obtain, maintain, enforce and protect patent protection for our technology and product candidates or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and product candidates may be adversely affected.

•

Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to control all matters submitted to stockholders for approval.

Table of Contents

		Page
PART I.	FINANCIAL INFORMATION	1
Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets as of June 30, 2021 and December 31, 2020	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2021 and 2020	2
	Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the Three and Six Months Ended June 30, 2021 and 2020	3
	Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2021 and 2020	5
	Notes to Unaudited Condensed Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	29
Item 4.	Controls and Procedures	30
PART II.	OTHER INFORMATION	31
Item 1A.	Risk Factors	31
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	74
Item 6.	Exhibits	75
Signatures		76

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

IMARA INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)
(Unaudited)

	June 30, 2021			December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	48,037		$	47,698
Short-term investments		18,731			40,524
Prepaid expenses and other current assets		4,589			2,183
Total current assets		71,357			90,405
Property and equipment, net	299				349
Right of use assets - operating leases	637				—
Other assets	175				88
Total assets	$	72,468		$	90,842
LIABILITIES & STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	2,626		$	1,971
Accrued expenses and other current liabilities		4,093			4,276
Operating lease liability, current		254			—
Total current liabilities		6,973			6,247
Deferred rent		—			160
Operating lease liability, non-current	528				—
Total liabilities		7,501			6,407
Commitments and contingencies (Note 7)
Preferred stock, $0.001 par value per share; 10,000,000 shares authorized; no shares issued or outstanding as of June 30, 2021; no shares authorized, issued or outstanding as of December 31, 2020		—			—
Common stock, $0.001 par value per share; 200,000,000 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 17,910,937 and 17,548,263 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively	19				18
Additional paid-in capital		184,479			180,526
Accumulated other comprehensive income		—			4
Accumulated deficit		(119,531	)		(96,113	)
Total stockholders’ equity		64,967			84,435
Total liabilities and stockholders’ equity	$	72,468		$	90,842

The accompanying notes are an integral part of these condensed consolidated financial statements.

IMARA INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share data)
(Unaudited)

	Three Months Ended June 30,						Six Months Ended June 30,
	2021			2020			2021			2020
Operating expenses:
Research and development	$	10,074		$	7,869		$	17,189		$	13,662
General and administrative		3,095			2,433			6,260			3,992
Total operating expenses		13,169			10,302			23,449			17,654
Loss from operations		(13,169	)		(10,302	)		(23,449	)		(17,654	)
Total other income, (net):
Interest income		48			110			131			242
Other expense		(40	)		(12	)		(100	)		(7	)
Total other income, (net)		8			98			31			235
Net loss	$	(13,161	)	$	(10,204	)	$	(23,418	)	$	(17,419	)
Accretion of Series B convertible preferred stock		—			—			—			(7,858	)
Net loss attributable to common stockholders—basic and diluted	$	(13,161	)	$	(10,204	)	$	(23,418	)	$	(25,277	)
Weighted-average common shares outstanding—basic and diluted		17,715,474			17,194,795			17,647,476			10,344,077
Net loss per share attributable to common stockholders—basic and diluted	$	(0.74	)	$	(0.59	)	$	(1.33	)	$	(2.44	)
Comprehensive loss:
Net loss	$	(13,161	)	$	(10,204	)	$	(23,418	)	$	(17,419	)
Other comprehensive income:
Unrealized gain (loss) on investments (net)		(1	)		64			(4	)		16
Comprehensive loss	$	(13,162	)	$	(10,140	)	$	(23,422	)	$	(17,403	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

IMARA INC.

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

(in thousands, except share and per share data)
(Unaudited)

	CONVERTIBLE PREFERRED STOCK																		COMMON
	SERIES SEED $0.001 PAR VALUE						SERIES A $0.001 PAR VALUE						SERIES B $0.001 PAR VALUE						STOCK $0.001 PAR VALUE				ADDITIONAL PAID-IN			ACCUMULATED OTHER COMPREHENSIVE			ACCUMULATED			TOTAL STOCKHOLDERS’ EQUITY
	SHARES			AMOUNT			SHARES			AMOUNT			SHARES			AMOUNT			SHARES		AMOUNT		CAPITAL			INCOME (LOSS)			DEFICIT			(DEFICIT)
Balance at December 31, 2019		2,712,960		$	1,460			31,499,040		$	30,729			26,321,313		$	45,575			702,510	$	1	$	5,872		$	32		$	(54,753	)	$	(48,848	)
Issuance of Series B convertible preferred stock, net of issuance costs of $20 and beneficial conversion charge		—			—			—			—			9,845,348			9,271			—		—		7,858			—			—			7,858
Accretion of Series B converted preferred stock		—			—			—			—			—			7,858			—		—		(7,858	)		—			—			(7,858	)
Conversion of convertible preferred stock into common stock		(2,712,960	)		(1,460	)		(31,499,040	)		(30,729	)		(36,166,661	)		(62,704	)		11,172,955		11		94,882			—			—			94,893
Initial public offering, net of underwriting discounts, commissions and offering costs of $3,885		—			—			—			—			—			—			4,700,000		5		66,047			—			—			66,052
Stock-based compensation expense		—			—			—			—			—			—			—		—		360			—			—			360
Unrealized loss on investments		—			—			—			—			—			—			—		—		—			(48	)		—			(48	)
Net loss		—			—			—			—			—			—			—		—		—			—			(7,215	)		(7,215	)
Balance at March 31, 2020		—		$	—			—		$	—			—		$	—			16,575,465	$	17	$	167,161		$	(16	)	$	(61,968	)	$	105,194
Initial public offering, net of underwriting discounts, commissions and offering costs of $17		—			—			—			—			—			—			705,000		1		10,473			—			—			10,474
Exercise of stock options		—			—			—			—			—			—			44,271		—		218			—			—			218
Stock-based compensation expense		—			—			—			—			—			—			—		—		550			—			—			550
Unrealized gain on investments		—			—			—			—			—			—			—		—		—			64			—			64
Net loss		—			—			—			—			—			—			—		—		—			—			(10,204	)		(10,204	)
Balance at June 30, 2020		—		$	—			—		$	—			—		$	—			17,324,736	$	18	$	178,402		$	48		$	(72,172	)	$	106,296

	COMMON
	STOCK $0.001 PAR VALUE				ADDITIONAL PAID-IN		ACCUMULATED OTHER COMPREHENSIVE			ACCUMULATED			TOTAL STOCKHOLDERS’
	SHARES		AMOUNT		CAPITAL		INCOME (LOSS)			DEFICIT			EQUITY
Balance at December 31, 2020		17,548,263	$	18	$	180,526	$	4		$	(96,113	)	$	84,435
Stock-based compensation expense		—		—		947		—			—			947
Exercise of stock options		68,279		—		472		—			—			472
Unrealized loss on investments		—		—		—		(3	)		—			(3	)
Net loss		—		—		—		—			(10,257	)		(10,257	)
Balance at March 31, 2021		17,616,542	$	18	$	181,945	$	1		$	(106,370	)	$	75,594
Stock-based compensation expense		—		—		917		—			—			917
Issuance of common stock under ATM offering, net of issuance costs of $357		231,291		1		1,344		—			—			1,345
Exercise of stock options and issuance of stock under the Employee Stock Purchase Plan		63,104		—		273		—			—			273
Unrealized loss on investments		—		—		—		(1	)		—			(1	)
Net loss		—		—		—		—			(13,161	)		(13,161	)
Balance at June 30, 2021		17,910,937	$	19	$	184,479	$	—		$	(119,531	)	$	64,967

The accompanying notes are an integral part of these condensed consolidated financial statements.

IMARA INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

	Six Months Ended June 30,
	2021			2020
Cash flows from operating activities:
Net loss	$	(23,418	)	$	(17,419	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		1,864			910