10-Q

SEC Form 10-Q filed by Savara Inc.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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 March 31, 2024


☐	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 001-32157

Savara Inc.

(Exact name of registrant as specified in its charter)


Delaware		84-1318182
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

1717 Langhorne Newtown Road, Suite 300 Langhorne, Pennsylvania		19047
(Address of principal executive offices)		(Zip Code)

(512) 614-1848

(Registrant’s telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report)

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

    SVRA

    The Nasdaq Global Select Market

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. ☐


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 May 9, 2024, the registrant had 138,188,891 shares of common stock, $0.001 par value per share, outstanding.

Table of Contents


		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
	Consolidated Statements of Changes in Stockholders’ 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	17
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	21
Item 4.	Controls and Procedures	21
PART II.	OTHER INFORMATION	22
Item 1.	Legal Proceedings	22
Item 1A.	Risk Factors	22
Item 2.	Unregistered Shares of Equity Securities and Use of Proceeds	22
Item 3.	Defaults Upon Senior Securities	22
Item 4.	Mine Safety Disclosures	22
Item 5.	Other Information	22
Item 6.	Exhibits	22
Exhibit Index		23
Signatures		24

PART I – FINANCIAL INFORMATION

Item I. Financial Information

Savara Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)


	March 31, 2024			December 31, 2023
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	16,785		$	26,585
Short-term investments		126,258			135,734
Prepaid expenses and other current assets		3,144			3,628
Total current assets		146,187			165,947
Property and equipment, net		248			270
In-process R&D		10,712			10,960
Other non-current assets		1,148			387
Total assets	$	158,295		$	177,564
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	2,853		$	3,504
Accrued expenses and other current liabilities		6,957			7,093
Total current liabilities		9,810			10,597
Long-term liabilities:
Long-term debt		26,416			26,348
Other long-term liabilities		208			247
Total liabilities		36,434			37,192
Commitments and contingencies (Note 9)
Stockholders’ equity:
Common stock, $0.001 par value, 300,000,000 authorized as of March 31, 2024 and December 31, 2023; 138,176,641 and 138,143,545 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively		140			140
Additional paid-in capital		536,178			533,872
Accumulated other comprehensive loss		(742	)		(271	)
Accumulated deficit		(413,715	)		(393,369	)
Total stockholders' equity		121,861			140,372
Total liabilities and stockholders’ equity	$	158,295		$	177,564

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

Savara Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)


	For the three months ended March 31,
	2024			2023
Operating expenses:
Research and development	$	16,807		$	8,738
General and administrative		5,636			3,366
Depreciation and amortization		32			8
Total operating expenses		22,475			12,112
Loss from operations		(22,475	)		(12,112	)
Other income (expense)
Interest income		1,353			765
Foreign currency exchange gain (loss)		(21	)		29
Tax credit income		797			761
Total other income, net		2,129			1,555
Net loss	$	(20,346	)	$	(10,557	)
Net loss per share:
Basic and diluted	$	(0.11	)	$	(0.07	)
Weighted-average common shares outstanding:
Basic and diluted		182,550,109			152,781,580
Other comprehensive income (loss):
Gain (loss) on foreign currency translation		(220	)		130
Unrealized gain (loss) on short-term investments		(251	)		14
Total comprehensive loss	$	(20,817	)	$	(10,413	)

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

Savara Inc. and Subsidiaries

Condensed Consolidated Statements of Changes in Stockholders’ Equity

Periods Ended March 31, 2024 and 2023

(In thousands, except share amounts)

(Unaudited)


	Stockholders’ Equity
	Common Stock
	Number of Shares			Amount		Additional Paid-In Capital			Accumulated Deficit			Accumulated Other Comprehensive Income (Loss)			Total
Balance on December 31, 2023		138,143,545		$	140	$	533,872		$	(393,369	)	$	(271	)	$	140,372
Issuance of common stock upon exercise of stock options		31,914			—		51			—			—			51
Issuance of common stock for settlement of RSUs		1,563			—		—			—			—			—
Repurchase of shares for minimum tax withholdings		(381	)		—		(2	)		—			—			(2	)
Stock-based compensation		—			—		2,257			—			—			2,257
Foreign exchange translation adjustment		—			—		—			—			(220	)		(220	)
Unrealized loss on short-term investments		—			—		—			—			(251	)		(251	)
Net loss		—			—		—			(20,346	)		—			(20,346	)
Balance on March 31, 2024		138,176,641		$	140	$	536,178		$	(413,715	)	$	(742	)	$	121,861

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

Savara Inc. and Subsidiaries

Condensed Consolidated Statements of Changes in Stockholders’ Equity (continued)

Periods Ended March 31, 2024 and 2023

(In thousands, except share amounts)

(Unaudited)


	Stockholders’ Equity
	Common Stock
	Number of Shares			Amount		Additional Paid-In Capital			Accumulated Deficit			Accumulated Other Comprehensive Income (Loss)			Total
Balance on December 31, 2022		114,046,345		$	116	$	446,938		$	(338,671	)	$	(605	)	$	107,778
Issuance of common stock upon exercise of options		17,129			—		27			—			—			27
Issuance of common stock for settlement of RSUs		1,813			—		—			—			—			—
Repurchase of shares for minimum tax withholdings		(551	)		—		(1	)		—			—			(1	)
Stock-based compensation		—			—		864			—			—			864
Foreign exchange translation adjustment		—			—		—			—			130			130
Unrealized gain on short-term investments		—			—		—			—			14			14
Net loss		—			—		—			(10,557	)		—			(10,557	)
Balance on March 31, 2023		114,064,736		$	116	$	447,828		$	(349,228	)	$	(461	)	$	98,255

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

Savara Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

For the three months ended March 31,

Cash flows from operating activities:

Adjustments to reconcile net loss to net cash used in operating activities: