SEC Filing - Aileron

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alrn-10q_20210930.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 September 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: 001-38130

Aileron Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware		13-4196017
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

285 Summer Street, Suite 101 Boston, MA		02210
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (617) 995-0900

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, $0.001 par value per share	ALRN	The Nasdaq Capital 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 November 9, 2021, the registrant had 90,573,597 shares of common stock, $0.001 par value per share, outstanding.

Table of Contents

		Page
PART I.	FINANCIAL INFORMATION		5
Item 1.	Financial Statements (Unaudited)		5
	Condensed Balance Sheets		5
	Condensed Statements of Operations and Comprehensive Loss		6
	Condensed Statement of Stockholders’ Equity		7
	Condensed Statements of Cash Flows		8
	Notes to Financial Statements		9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		20
Item 3.	Quantitative and Qualitative Disclosures About Market Risk		31
Item 4.	Controls and Procedures		31
PART II.	OTHER INFORMATION		33
Item 1.	Legal Proceedings		33
Item 1A.	Risk Factors		33
Item 6.	Exhibits		72
	Signatures		73

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, 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 and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “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.

These forward-looking statements include, among other things, statements about:

•

our plans to develop and commercialize ALRN-6924, including the potential benefits thereof;

•

our ongoing and future clinical trials for ALRN-6924, whether conducted by us or by any future collaborators, including the timing of initiation of these trials and of the anticipated results;

•

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

•

our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

•

the timing of and our ability to obtain and maintain marketing approvals for our product candidates;

•

the rate and degree of market acceptance and clinical utility of any products for which we receive marketing approval;

•

our commercialization, marketing and manufacturing capabilities and strategy;

•

our intellectual property position and strategy;

•

our ability to identify additional product candidates with significant commercial potential;

•

our plans to enter into collaborations for the development and commercialization of product candidates;

•

potential benefits of any future collaboration;

•

developments relating to our competitors and our industry;

•

the impact of government laws and regulations;

•

the impact the coronavirus pandemic may have on the timing of our clinical development and on our operations; and

•

our ability to maintain our listing on the Nasdaq Capital Market.

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. 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 in this Quarterly Report on Form 10-Q, particularly in the “Risk Factors” section, that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments that we may make or enter into.

You should read this Quarterly Report on Form 10-Q and the documents that we reference herein and have filed or incorporated by reference hereto completely and with the understanding that our actual future results may be materially different from what we expect. 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 law.

This Quarterly Report on Form 10-Q includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information.

Summary Risk Factors

Our business is subject to a number of risks of which you should be aware in evaluating our company and our business. These risks are discussed more fully in the “Risk Factors” section of this Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. These risks include the following:

•

Our business depends entirely on the successful development and commercialization of our product candidate, ALRN-6924. Our clinical trials of ALRN-6924 may not be successful. If our trials prove unsuccessful or if we are unable to obtain approval for and commercialize ALRN-6924 or experience significant delays in doing so, our business will be materially harmed.

•

We will need substantial additional funding to continue our operations. Our cash, cash equivalents and investments are not sufficient to enable us to complete the development of or commercialize ALRN-6924. If we are unable to raise capital when needed, we may be forced to delay, reduce and/or eliminate our research and drug development programs, reduce headcount, and future commercialization efforts, or take other actions that could adversely affect our business.

•

We have incurred significant losses since inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability. Even if we are able to develop and commercialize ALRN-6924, we may never generate revenues that are significant or large enough to achieve profitability.

•

The COVID-19 pandemic has affected and may continue to affect our ability to conduct our ongoing and planned clinical trials, disrupt regulatory activities, or have other adverse effects on our business and operations. In addition, this pandemic has caused substantial disruption in the financial markets and may adversely impact economies worldwide, which could result in adverse effects on our business and operations.

•

The approach we are taking to discover and develop novel drugs is unproven and may never lead to marketable products.

•

We are pursuing the development of ALRN-6924 as a chemoprotective agent in combination with approved chemotherapeutics. If the U.S. Food and Drug Administration, or the FDA, revokes approval of any such chemotherapeutic, or if safety, efficacy, manufacturing or supply issues arise with any therapeutic that we use in combination with ALRN-6924 in the future, we may be unable to further develop and/or market ALRN-6924, or we may experience significant regulatory delays, and our business could be materially harmed.

•

The outcome of preclinical testing and early clinical trials, such as the results of our Phase 1b trial of ALRN-6924 in patients with small cell lung cancer, may not be predictive of the success of later clinical trials, interim results of a clinical trial, do not necessarily predict final results and the results of our clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities. In addition, results of clinical trials of ALRN-6924 when used with one chemotherapy or in one patient population may not be predictive of the results of other clinical trials of ALRN-6924 when used with a different chemotherapy or in a different patient population.

•

Clinical drug development is a lengthy and expensive process, with an uncertain outcome. If clinical trials of ALRN-6924 or any other product candidate that we may develop fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs, experience delays in completing, or ultimately be unable to complete, the development of ALRN-6924 or any other product candidate that we may develop or be unable to obtain marketing approval.

•

We are conducting clinical trials of ALRN-6924 and plan to conduct additional clinical trials of ALRN-6924 at sites outside the United States. The FDA’s acceptance of data from clinical trials outside of the United States is subject to conditions. Accordingly, the FDA may not accept data from trials conducted in such locations and the conduct of trials outside the United States could subject us to additional delays and expense.

•

We may not be able to initiate or continue clinical trials for ALRN-6924 or any other product candidate that we may develop if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or comparable foreign regulatory authorities. Patient enrollment is a significant factor in the timing of clinical trials. We do not yet know exactly how many patients will have the genetic profile that ALRN-6924 or other future product candidates are designed to address. In particular, because our clinical trials are targeted at a subset of patients in indications with p53-mutated cancers, our ability to enroll eligible patients may be limited or may result in slower enrollment than we anticipate.

•

If serious adverse or unacceptable side effects are identified during the development of ALRN-6924 or any other product candidate that we may develop or we observe limited efficacy of ALRN-6924 or any other product candidate that we may develop, we may need to abandon or limit the development of ALRN-6924 or other product candidates that we may develop.

•

The FDA or comparable foreign regulatory authorities may, under certain circumstances, require that a companion diagnostic be approved for use with ALRN-6924. If we are unable to successfully develop and obtain approval for such a diagnostic, either on our own or through a third party, or if we experience significant delays in doing so, we may not obtain marketing approval for ALRN-6924 in a timely manner, or at all.

•

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

•

We rely on third parties to conduct our clinical trials and some aspects of our research and preclinical studies, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research and studies.

•

We contract with third parties for the manufacture of our ALRN-6924 for our ongoing clinical trials and expect to continue to do so for additional clinical trials and ultimately for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of ALRN-6924 or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

•

We may seek to enter into strategic collaborations for the development, marketing and commercialization of ALRN-6924 or other product candidates. If we are unable to enter into collaborations or those collaborations into which we enter are not successful, the development, marketing and/or commercialization of ALRN-6924 or such other product candidates that are the subject of such collaborations would be harmed.

•

Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.

•

If we fail to comply with our obligations under our patent licenses with third parties, we could lose license rights that are important to our business.

•

Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us, or any future collaborators, from obtaining approvals for the commercialization of ALRN-6924 or any other product candidate that we may develop. As a result, we cannot predict when or if, and in which territories or for which indications, we, or any future collaborators, will obtain marketing approval to commercialize ALRN-6924 or any other product candidate that we may develop.

•

Even if ALRN-6924 receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

PART I—FINANCIAL INFORMATION

Item 1.

Financial Statements.

AILERON THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS (UNAUDITED)

(In thousands, except share and per share data)

	September 30, 2021			December 31, 2020
Assets
Current assets:
Cash and cash equivalents	$	7,603		$	7,046
Investments		44,629			6,759
Prepaid expenses and other current assets		2,166			1,928
Restricted cash		25			593
Total current assets		54,423			16,326
Operating lease, right-of-use asset		177			—
Other non-current assets		24			—
Property and equipment, net		144			15
Total assets	$	54,768		$	16,341
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,035		$	1,596
Accrued expenses and other current liabilities		3,432			2,196
Paycheck Protection Program loan, current portion		—			168
Operating lease liability, current portion		93			—
Total current liabilities		4,560			3,960
Paycheck Protection Program loan, net of current portion		—			219
Operating lease liability, net of current portion		99			—
Total liabilities		4,659			4,179
Commitments and contingencies (Note 11)
Stockholders’ equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized and no shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively		—			—
Common stock, $0.001 par value; 300,000,000 and 150,000,000 shares authorized at September 30, 2021 and December 31, 2020, respectively; 90,572,555 and 43,804,175 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively		91			44
Additional paid-in capital		288,674			231,412
Accumulated other comprehensive gain/(loss)		1			(2	)
Accumulated deficit		(238,657	)		(219,292	)
Total stockholders’ equity		50,109			12,162
Total liabilities and stockholders’ equity	$	54,768		$	16,341

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

AILERON THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)

(In thousands, except share and per share data)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2021			2020			2021			2020
Revenue	$	—		$	—		$	—		$	—
Operating expenses:
Research and development		4,278			2,684			12,447			9,241
General and administrative		2,513			2,344			7,342			7,063
Total operating expenses		6,791			5,028			19,789			16,304
Loss from operations		(6,791	)		(5,028	)		(19,789	)		(16,304	)
Interest income		21			5			54			77
Other income, net		66			—			370			66
Net loss		(6,704	)		(5,023	)		(19,365	)		(16,161	)
Net loss per share — basic and diluted	$	(0.07	)	$	(0.13	)	$	(0.22	)	$	(0.49	)
Weighted average common shares outstanding—basic and diluted		90,548,972			39,321,177			88,211,362			32,808,082
Comprehensive loss:
Net loss	$	(6,704	)	$	(5,023	)	$	(19,365	)	$	(16,161	)
Other comprehensive loss:
Unrealized gain (loss) on investments, net of tax of $0		(5	)		1			3			(8	)
Total other comprehensive gain (loss)		(5	)		1			3			(8	)
Total comprehensive loss	$	(6,709	)	$	(5,022	)	$	(19,362	)	$	(16,169	)

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

AILERON THERAPEUTICS, INC.

CONDENSED STATEMENT OF STOCKHOLDERS’ EQUITY (UNAUDITED)

(In thousands, except share and per share data)

	Common Stock				Additional			Accumulated Other						Total
	Shares		Par Value		Paid-in Capital			Comprehensive Loss			Accumulated Deficit			Stockholders' Equity
Balances at December 31, 2020		43,804,175	$	44	$	231,412		$	(2	)	$	(219,292	)	$	12,162
Issuance of common stock		46,406,382		46		59,042			—			—			59,088
Issuance costs		—		—		(3,482	)		—			—			(3,482	)
Stock-based compensation expense		—		—		631			—			—			631
Unrealized loss on investments		—		—		—			(5	)		—			(5	)
Net loss		—		—		—			—			(6,975	)		(6,975	)
Balances at March 31, 2021		90,210,557	$	90	$	287,603		$	(7	)	$	(226,267	)	$	61,419
Exercise of stock options		67,357		—		47			—			—			47
Issuance costs		—		—		(24	)		—			—			(24	)
RSU's vested		250,000		—		—			—			—			—
Stock-based compensation expense		—		—		361			—			—			361
Unrealized gain on investments		—		—		—			13			—			13
Net loss		—		—		—			—			(5,686	)		(5,686	)
Balances at June 30, 2021		90,527,914	$	90	$	287,987		$	6		$	(231,953	)	$	56,130
Exercise of stock options		44,641		1		26			—			—			27
Stock-based compensation expense		—		—		661			—			—			661
Unrealized loss on investments		—		—		—			(5	)		—			(5	)
Net loss		—		—		—			—			(6,704	)		(6,704	)
Balances at September 30, 2021		90,572,555	$	91	$	288,674		$	1		$	(238,657	)	$	50,109

Balances at December 31, 2019		27,810,358	$	28	$	214,148		$	7		$	(198,135	)	$	16,048
Issuance costs		—		—		(28	)		—			—			(28	)
Stock-based compensation expense		—		—		505			—			—			505
Unrealized loss on investments		—		—		—			(8	)		—			(8	)
Net loss		—		—		—			—			(6,748	)		(6,748	)
Balances at March 31, 2020		27,810,358	$	28	$	214,625		$	(1	)	$	(204,883	)	$	9,769
Issuance costs		—		—		(1,186	)		—			—			(1,186	)
Issuance of common stock		11,425,118		11		11,904			—			—			11,915
RSU's vested, net of shares withheld		26,100		—		(13	)		—			—			(13	)
Stock-based compensation expense		—		—		560			—			—			560
Unrealized loss on investments		—		—		—			(1	)		—			(1	)
Net loss		—		—		—			—			(4,390	)		(4,390	)
Balances at June 30, 2020		39,261,576	$	39	$	225,890		$	(2	)	$	(209,273	)	$	16,654
Issuance of common stock, net of issuance costs of $159		606,747		1		363			—			—			364
RSUs vested, net of shares repurchased for tax		6,524		—		(3	)		—			—			(3	)
Stock-based compensation expense		—		—		465			—			—			465
Unrealized gain on investments		—		—		—			1			—			1
Net loss		—		—		—			—			(5,023	)		(5,023	)
Balances at September 30, 2020		39,874,847	$	40	$	226,715		$	(1	)	$	(214,296	)	$	12,458

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

AILERON THERAPEUTICS, INC.

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)

(In thousands)

	Nine Months Ended September 30,
	2021			2020
Cash flows from operating activities:
Net loss	$	(19,365	)	$	(16,161	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense		81			153
Net amortization of premiums and discounts on investments		212			(19	)
Stock-based compensation expense		1,653			1,530
Forgiveness of Paycheck Protection Program loan		(387	)		—
Gain on sale of property and equipment		(66	)		(66	)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(238	)		(580	)
Other assets		(24	)		510
Accounts payable		(564	)		(451	)
Operating lease liabilities		(36	)		(325	)
Accrued expenses and other current liabilities		1,235			(378