Allovir, Inc. [ALVR] Filings

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

10-Q 1 alvr-20230630.htm 10-Q 10-Q

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 June 30, 2023


☐	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: 001-39409

ALLOVIR, INC.

(Exact Name of Registrant as Specified in its Charter)


Delaware		83-1971007
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)
1100 Winter Street, Waltham, MA		02451
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (617) 433-2605

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 $0.0001 per share

ALVR

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, 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 July 28, 2023, the registrant had 113,868,112 shares of common stock, $0.0001 par value per share, outstanding.

Table of Contents


		Page
PART I.	FINANCIAL INFORMATION	4
Item 1.	Financial Statements (unaudited)	4
	Condensed Consolidated Balance Sheets	4
	Condensed Consolidated Statements of Operations and Comprehensive Loss	5
	Condensed Consolidated Statements of Changes in Stockholders’ Equity	6
	Condensed Consolidated Statements of Cash Flows	8
	Notes to Condensed Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	26

PART II.	OTHER INFORMATION	27
Item 1.	Legal Proceedings	27
Item 1A.	Risk Factors	27
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	70
Item 3.	Defaults Upon Senior Securities	70
Item 4.	Mine Safety Disclosures	70
Item 5.	Other Information	70
Item 6.	Exhibits	71

Signatures		72

Summary of Material Risks Associated with Our Business

Our business is subject to numerous risks and uncertainties that you should be aware of before making an investment decision, including those highlighted in the section entitled “Risk Factors.” These risks include, but are not limited to, the following:

•

We are a late clinical-stage cell therapy company and we have incurred net losses since our inception. We anticipate that we will continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.

•

Our business is highly dependent on our lead product candidate, posoleucel (previously referred to as Viralym-M or ALVR105), and we must complete clinical testing before we can seek regulatory approval and begin commercialization of any of our product candidates.

•

We depend substantially on intellectual property licensed from third parties, including Baylor College of Medicine, or BCM, and termination of any of these licenses could result in the loss of significant rights, which would harm our business.

•

If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates and manufacturing process, or if the scope of the intellectual property protection is not sufficiently broad, our ability to commercialize our product candidates successfully and to compete effectively may be adversely affected.

•

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

•

We have a limited operating history, which may make it difficult to evaluate the success of our business to date and to assess our future viability.

•

We are early in our development efforts and have only a small number of product candidates in clinical development. All of our other product candidates are still in preclinical development. If we or our collaborators are unable to successfully develop and commercialize product candidates or experience significant delays in doing so, our business may be materially harmed.

•

Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and the inability to successfully and timely conduct clinical trials and obtain regulatory approval for our product candidates would substantially harm our business.

•

The results of preclinical studies or earlier clinical trials are not necessarily predictive of future results. Our existing product candidates in clinical trials, and any other product candidate we advance into clinical trials, may not have favorable results in later clinical trials or receive regulatory approval.

•

Our product candidates, the methods used to deliver them or their dosage levels may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following any regulatory approval.

•

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

•

We and our third-party partners are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our product candidates.

•

We intend to develop an efficient and highly productive manufacturing supply chain for our allogeneic, off-the-shelf single- and multi-virus specific T cell therapies. Delays in process performance qualification to validate the drug product manufacturing process could delay regulatory approvals, our development plans and thereby limit our ability to generate revenues.

•

We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

•

The trading price of our common stock may be volatile.

•

Our business could be adversely affected by the effects of health epidemics, like the COVID-19 pandemic, in regions where our contracted third parties, including contract research organizations, or CROs, and contract development and manufacturing organizations, or CMOs or CDMOs, have significant research, development or manufacturing facilities, concentrations of clinical trial sites or other business operations, causing disruption in supplies and services.

The summary risk factors described above should be read together with the text of the full risk factors below, in the section entitled “Risk Factors” and the other information set forth in this Quarterly Report on Form 10-Q, including our consolidated financial statements and the related notes, as well as in other documents that we file with the SEC. The risks summarized above or described in full below are not the only risks that we face. Additional risks and uncertainties not precisely known to us, or that we currently deem to be immaterial may also materially adversely affect our business, financial condition, results of operations and future growth prospects.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements, including but not limited to, statements about:

•

the success, cost, timing and potential indications of our product development activities and clinical trials, including the ongoing and future clinical trials of posoleucel and ALVR106;

•

the timing of our planned Investigational New Drug, or IND, submissions to the U.S. Food and Drug Administration, or FDA, for our product candidates, including ALVR107;

•

the timing of the initiation, enrollment and completion of planned clinical trials;

•

our plans to research, develop and commercialize our product candidates, including posoleucel, ALVR106, and ALVR107;

•

the timing of the initiation, completion and outcomes of our preclinical studies;

•

the costs of development of any of our product candidates or clinical development programs and our ability to obtain funding for our operations, including funding necessary to complete the clinical trials of any of our product candidates;

•

our ability to successfully manufacture and distribute posoleucel, ALVR106 or any other future product or product candidate;

•

the potential benefits of and our ability to maintain our collaboration with our existing collaborators, including BCM, and establish or maintain future collaborations or strategic relationships or obtain additional funding;

•

the ability to maintain our existing license agreements, including Baylor College of Medicine, or BCM, and to license additional intellectual property relating to any future product candidates and to comply with our existing license agreements;

•

our ability to attract and retain collaborators with development, regulatory and commercialization expertise;

•

risks associated with the COVID-19 pandemic, including the emergence of new variants, which may adversely impact our business and clinical trials;

•

the size of the markets for our VST product candidates, and our ability to serve those markets;

•

whether the results of our clinical trials will be sufficient to support domestic or foreign regulatory approvals for any of our product candidates;

•

our ability to successfully commercialize our product candidates, including posoleucel and ALVR106;

•

the rate and degree of market acceptance of our product candidates, including posoleucel and ALVR106;

•

our ability to obtain and maintain regulatory approval of our product candidates in any of the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of any approved product we develop;

•

our ability to develop and maintain sales and marketing capabilities, whether alone or with potential future collaborators;

•

regulatory developments in the United States and foreign countries with respect to our product candidates or our competitors’ products and product candidates;

•

our reliance on third-party contract manufacturers and the performance of our third-party suppliers and manufacturers to manufacture and supply our product candidates for us;

•

the success of competing therapies that are or become available;

•

our ability to attract and retain key scientific or management personnel;

•

our expectation about the period of time over which our existing capital resources will be sufficient to fund our operating expenses and capital expenditures;

•

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

•

our financial performance;

•

the impact of laws and regulations;

•

developments and projections relating to our competitors or our industry;

•

the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and

•

our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and our ability to operate our business without infringing on the intellectual property rights of others.

In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these 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 report, 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. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.

You should read the section titled “Risk Factors” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q, if any, for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report on Form 10-Q will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

You should read this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (unaudited)

ALLOVIR, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

UNAUDITED


(in thousands, except share and per share amounts)	June 30, 2023			December 31, 2022
Assets
Current assets:
Cash and cash equivalents	$	196,954		$	106,092
Short-term investments		49,582			127,703
Interest receivable		106			157
Prepaid expenses and other current assets		4,737			7,100
Prepaid expenses to related party		1,533			2,000
Total current assets		252,912			243,052
Restricted cash		852			852
Other assets		684			612
Property and equipment, net		759			930
Operating lease right-of-use assets		27,485			31,633
Total assets	$	282,692		$	277,079
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	5,164		$	3,004
Accrued expenses		16,728			13,985
Income tax payable		127			128
Operating lease liability, current		8,483			7,165
Amount due to related party		61			56
Total current liabilities		30,563			24,338
Operating lease liability, long-term		23,016			28,222
Total liabilities	$	53,579		$	52,560
Stockholders’ equity:
Preferred stock, $0.0001 par value: 10,000,000 shares authorized at June 30, 2023 and December 31, 2022, respectively; 0 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively		—			—
Common stock, $0.0001 par value: 300,000,000 and 150,000,000 shares authorized at June 30, 2023 and December 31, 2022, respectively; 113,729,743 and 93,268,069 shares issued at June 30, 2023 and December 31, 2022, respectively; and 113,716,018 and 93,093,243 shares outstanding at June 30, 2023 and December 31, 2022, respectively		11			9
Additional paid-in capital		781,552			690,753
Accumulated other comprehensive loss		(225	)		(468	)
Accumulated deficit		(552,225	)		(465,775	)
Total stockholders’ equity		229,113			224,519
Total liabilities and stockholders’ equity	$	282,692		$	277,079

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

ALLOVIR, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

UNAUDITED


	Three Months Ended June 30,						Six Months Ended June 30,
(in thousands, except share and per share amounts)	2023			2022			2023			2022
Operating expenses:
Research and development	$	34,824		$	31,379		$	65,543		$	60,446
General and administrative		12,480			13,245			24,992			27,371
Total operating expenses		47,304			44,624			90,535			87,817
Loss from operations		(47,304	)		(44,624	)		(90,535	)		(87,817	)
Total other income (loss), net:
Interest income		1,516			162			2,841			310
Other income (loss), net		521			(27	)		1,244			(845	)
Loss before income taxes		(45,267	)		(44,489	)		(86,450	)		(88,352	)
Income tax expense		—			150			—			150
Net loss	$	(45,267	)	$	(44,639	)	$	(86,450	)	$	(88,502	)
Net loss per share — basic and diluted	$	(0.48	)	$	(0.69	)	$	(0.92	)	$	(1.38	)
Weighted-average common shares outstanding — basic and diluted		94,625,837			64,467,483			93,968,407			64,231,579
Comprehensive loss:
Net loss	$	(45,267	)	$	(44,639	)	$	(86,450	)	$	(88,502	)
Other comprehensive income (loss), net of tax:
Unrealized gain (loss) on available-for-sale securities		76			(94	)		243			(289	)
Total other comprehensive income (loss)		76			(94	)		243			(289	)
Comprehensive loss	$	(45,191	)	$	(44,733	)	$	(86,207	)	$	(88,791	)

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

ALLOVIR, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

UNAUDITED


	Common Stock				Additional Paid-In		Accumulated Other Comprehensive			Accumulated			Total Stockholders’
(in thousands, except share amounts)	Shares		Amount		Capital		Loss			Deficit			Equity
Balance at December 31, 2021		63,565,886	$	7	$	522,479	$	(155	)	$	(297,065	)	$	225,266
Stock-based compensation		—		—		10,467		—			—			10,467
Issuance of common stock, upon vesting of restricted stock		698,241		—		—		—			—			—
Unrealized loss on available-for-sale securities		—		—		—		(195	)		—			(195	)
Net loss		—		—		—		—			(43,863	)		(43,863	)
Balance at March 31, 2022		64,264,127	$	7	$	532,946	$	(350	)	$	(340,928	)	$	191,675
Stock-based compensation		—		—		10,951		—			—			10,951
Issuance of common stock, upon vesting of restricted stock		450,619		—		—		—			—			—
Purchase of common stock under the 2020 Employee Stock Purchase Plan		73,357		—		244		—			—			244
Unrealized loss on available-for-sale securities		—		—		—		(94	)		—			(94	)
Net loss		—		—		—		—			(44,639	)		(44,639	)
Balance at June 30, 2022		64,788,103	$	7	$	544,141	$	(444	)	$	(385,567	)	$	158,137

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

ALLOVIR, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

UNAUDITED


	Common Stock				Additional Paid-In		Accumulated Other Comprehensive			Accumulated			Total Stockholders’
(in thousands, except share amounts)	Shares		Amount		Capital		Loss			Deficit			Equity
Balance at December 31, 2022		93,093,243	$	9	$	690,753	$	(468	)	$	(465,775	)	$	224,519
Stock-based compensation		—		—		10,029		—			—			10,029
Issuance of common stock, upon vesting of restricted stock		334,747		—		—		—			—			—
Unrealized gain on available-for-sale securities		—		—		—		167			—			167
Net loss		—		—		—		—			(41,183	)		(41,183	)
Balance at March 31, 2023		93,427,990	$	9	$	700,782	$	(301	)	$	(506,958	)	$	193,532
Stock-based compensation		—		—		10,288		—			—			10,288
Issuance of common stock, upon vesting of restricted stock		179,092		—		—		—			—			—
Purchase of common stock under the 2020 Employee Stock Purchase Plan		108,936		—		315		—			—			315
Issuance of common stock in public offering, net of underwriting discounts, commissions and offering costs		20,000,000		2		70,167		—			—			70,169
Unrealized gain on available-for-sale securities		—		—		—		76			—			76
Net loss		—		—		—		—			(45,267	)		(45,267	)
Balance at June 30, 2023		113,716,018		11		781,552		(225	)		(552,225	)		229,113

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

ALLOVIR, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

UNAUDITED


	Six Months Ended June 30,
(in thousands)	2023			2022
Cash flows from operating activities
Net loss	$	(86,450	)	$	(88,502	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		171			552
Non-cash lease expense		233			720
(Accretion) amortization of short-term investment (discounts) premiums		(1,253	)		49
Stock-based compensation expense		20,317			21,418
Changes in operating assets and liabilities:
Interest receivable		51			(41	)
Prepaid expenses and other current assets and prepaid expenses to related party		2,856			1,423
Other assets		(72	)		245
Income tax payable		(1	)		(853	)
Accounts payable, accrued expenses and amount due to related party		4,908			(10,365	)
Net cash used in operating activities		(59,240	)		(75,354	)
Cash flows from investing activities
Purchase of short-term investments		(14,196	)		(92,783	)
Maturities of short-term investments		93,814			37,325
Net cash provided by (used in) investing activities		79,618			(55,458	)
Cash flows from financing activities
Proceeds from issuance of common stock in public offering, net of underwriting discounts, commissions and offering costs		70,169			—
Proceeds from issuance of stock under the 2020 Employee Stock Purchase Plan		315			244
Net cash provided by financing activities		70,484			244
Net increase (decrease) in cash, cash equivalents, and restricted cash		90,862			(130,568	)
Cash, cash equivalents, and restricted cash at beginning of period		106,944			202,513
Cash, cash equivalents, and restricted cash at end of period	$	197,806		$	71,945
Non-cash investing and financing activities
Unrealized gain (loss) on available-for-sale securities	$	243		$	(289	)
Deferred offering costs included in accounts payable and accrued expenses	$	331		$	—
Reduction of right-of-use asset and operating lease liability due to modification and remeasurement	$	—		$	(5,506	)
Supplemental disclosure of cash flows
Income taxes paid, net of refunds	$	350		$	1,003

	Six Months Ended June 30,
	2023			2022
Cash and cash equivalents	$	196,954		$	71,093
Restricted cash		852			852
Total cash, cash equivalents, and restricted cash	$	197,806		$	71,945

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

Allovir, Inc. [ALVR] Filings
10-Q	[2023-08-03]
10-Q	[2023-05-04]
10-K	[2023-02-15]
10-Q	[2022-11-03]
10-Q	[2022-08-04]
10-Q	[2022-05-05]
10-K	[2022-02-10]
10-Q	[2021-11-05]
10-Q	[2021-08-06]
10-Q	[2021-05-06]
10-K	[2021-02-12]
10-Q	[2020-11-10]
10-Q	[2020-09-02]
S-1	[2020-07-06]