alna-10q_20190331.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 March 31, 2019

OR

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: 001-38268

 

ALLENA PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

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

 

 

Delaware

45-2729920

( State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

One Newton Executive Park, Suite 202

Newton, Massachusetts

02462

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 467-4577

 

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.

 

Large accelerated filer

 

  

Accelerated filer

 

Non-accelerated filer

 

  

  

Small 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  

Securities registered or to be 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

ALNA

The Nasdaq Global Select Market

 

As of April 26, 2019, the registrant had 20,816,064 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. These statements include all matters that are not related to present facts or current conditions or that are not historical facts, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth. The words “anticipate,” “believe,” “could,” “continue,” “should,” “predict,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “will,” “may,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. 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.

We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q, regarding, among other things:

 

the design and conduct of our Phase 3 clinical program of reloxaliase (formerly referred to as ALLN-177) in enteric hyperoxaluria;

 

the number, designs, results and timing of our clinical trials and preclinical studies and the timing of the availability of data from these trials and activities;

 

our ability to enroll a sufficient number of patients and the ability of subjects in our clinical trials to adhere to the protocol, including capsule and dietary regimen and urinary collection requirements;

 

the therapeutic benefits, effectiveness and safety of reloxaliase, ALLN-346 and our future product candidates;

 

our expected regulatory pathway, and our ability to receive regulatory approval for our product candidates in the United States, Europe and other geographies;

 

our ability to obtain, on satisfactory terms or at all, the financing required to support operations, development, clinical trials, and commercialization of products;

 

our reliance on third-parties for the planning, conduct and monitoring of clinical trials and for the manufacture of clinical drug supplies and drug product;

 

potential changes in regulatory requirements, and delays or negative outcomes from the regulatory approval process;

 

our estimates of the size and characteristics of the markets that may be addressed by reloxaliase and ALLN-346;

 

the market acceptance of reloxaliase, ALLN-346 or any future product candidates that are approved for marketing in the United States or other countries;

 

our ability to successfully commercialize reloxaliase, if approved, with a targeted sales force;

 

the safety and efficacy of therapeutics marketed by our competitors that are targeted to indications which our product candidates have been developed to treat;

 

our ability to utilize our proprietary technological approach to develop and commercialize ALLN-346 and future product candidates;

 


 

 

potential collaborators to license and commercialize reloxaliase, if approved, or any products for which we receive regulatory approval in the future outside of the United States;

 

our heavy dependence on licensed intellectual property, including our ability to source and maintain licenses from third-party owners;

 

our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

 

our ability to attract, retain and motivate key personnel;

 

our ability to generate revenue and become profitable;

 

our expectations regarding the period during which we qualify as an emerging growth company under the Jumpstart Our Business Startups Act; and

 

our estimates regarding our capital requirements and our need for additional financing.

These risks are not exhaustive. Other sections of this Quarterly Report on Form 10-Q may include additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.

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. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. No forward-looking statement is a guarantee of future performance.

You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed as exhibits to the registration statement of which this Quarterly Report on Form 10-Q is a part completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements in this Quarterly Report on Form 10-Q represent our views as of the date of this Quarterly Report on Form 10-Q. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report on Form 10-Q.

 

 

 


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

2

Item 1.

Financial Statements (Unaudited)

2

 

Condensed Consolidated Balance Sheets

2

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

3

 

Condensed Consolidated Statements of Stockholders’ Equity

4

 

Condensed Consolidated Statements of Cash Flows

5

 

Notes to Unaudited Condensed Consolidated Financial Statements

6

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

14

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

22

Item 4.

Controls and Procedures

22

PART II.

OTHER INFORMATION

23

Item 1.

Legal Proceedings

23

Item 1A.

Risk Factors

23

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

64

Item 3.

Defaults Upon Senior Securities

64

Item 4.

Mine Safety Disclosures

64

Item 5.

Other Information

64

Item 6.

Exhibits

65

Signatures

66

 

 

 

 

 

 

 

 

1


 

PART I—FINANCIAL INFORMATION

Item 1.

Financial Statements.

Allena Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands, except share and per share data)

 

 

 

March 31,

2019

 

 

December 31,

2018

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

51,755

 

 

$

61,643

 

Prepaid expenses and other current assets

 

 

1,316

 

 

 

2,826

 

Total current assets

 

 

53,071

 

 

 

64,469

 

Property and equipment, net

 

 

486

 

 

 

514

 

Operating lease assets

 

 

866

 

 

 

 

Other assets

 

 

390

 

 

 

246

 

Total assets

 

$

54,813

 

 

$

65,229

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,600

 

 

$

2,138

 

Loan payable, net of discount

 

 

992

 

 

 

 

Operating lease liabilities, net of discount

 

 

513

 

 

 

 

Accrued expenses and other current liabilities

 

 

2,670

 

 

 

3,625

 

Total current liabilities

 

 

6,775

 

 

 

5,763

 

Loan payable, net of current portion and discount

 

 

8,982

 

 

 

9,980

 

Operating lease liabilities, net of current portion and discount

 

 

361

 

 

 

 

Other liabilities

 

 

16

 

 

 

30

 

Total liabilities

 

 

16,134

 

 

 

15,773

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Undesignated preferred stock, $0.001 par value; 5,000,000 shares authorized; no

   shares authorized, issued or outstanding

 

 

 

 

 

 

Common stock, $0.001 par value; 125,000,000 shares authorized; 20,816,064 and

   20,809,025 shares issued and outstanding at March 31, 2019 and December

   31, 2018, respectively

 

 

21

 

 

 

21

 

Additional paid-in capital

 

 

167,682

 

 

 

167,040

 

Accumulated deficit

 

 

(129,024

)

 

 

(117,605

)

Total stockholders’ equity

 

 

38,679

 

 

 

49,456

 

Total liabilities and stockholders’ equity

 

$

54,813

 

 

$

65,229

 

 

See accompanying notes.

 

2


 

Allena Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended March 31,

 

 

 

2019

 

 

2018

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

$

9,128

 

 

$

5,931

 

General and administrative

 

 

2,431

 

 

 

2,042

 

Total operating expenses

 

 

11,559

 

 

 

7,973

 

Loss from operations

 

 

(11,559

)

 

 

(7,973

)

Other income (expense):

 

 

 

 

 

 

 

 

Interest income, net

 

 

151

 

 

 

100

 

Other expense, net

 

 

(11

)

 

 

(7

)

Other income (expense), net

 

 

140

 

 

 

93

 

Net loss

 

$

(11,419

)

 

$

(7,880

)

Net loss per share attributable to common stockholders—basic and

   diluted

 

$

(0.55

)

 

$

(0.38

)

Weighted-average common shares outstanding—basic and diluted

 

 

20,814,715

 

 

 

20,695,386

 

Net loss

 

$

(11,419

)

 

$

(7,880

)

Comprehensive loss

 

$

(11,419

)

 

$

(7,880

)

 

See accompanying notes.

 

 

 

3


 

Allena Pharmaceuticals, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(unaudited)

(in thousands, except share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

stockholders’

 

 

 

Common stock

 

 

paid-in

 

 

Accumulated

 

 

equity

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

deficit

 

 

(deficit)

 

Balance at December 31, 2017

 

 

20,694,658

 

 

$

20

 

 

$

164,807

 

 

$

(81,957

)

 

$

82,870

 

Exercise of common stock options

 

 

898

 

 

 

 

 

 

1

 

 

 

 

 

 

1

 

Stock-based compensation

 

 

 

 

 

 

 

 

404

 

 

 

 

 

 

404

 

Issuance costs related to initial public offering

 

 

 

 

 

 

 

 

13

 

 

 

 

 

 

13

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(7,880

)

 

 

(7,880

)

Balance at March 31, 2018

 

 

20,695,556

 

 

$

20

 

 

$

165,225

 

 

$

(89,837

)

 

$

75,408

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2018

 

 

20,809,025

 

 

$

21

 

 

$

167,040

 

 

$

(117,605

)

 

$

49,456

 

Exercise of common stock options

 

 

7,039

 

 

 

 

 

 

13

 

 

 

 

 

 

13

 

Stock-based compensation

 

 

 

 

 

 

 

 

629

 

 

 

 

 

 

629

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(11,419

)

 

 

(11,419

)

Balance at March 31, 2019

 

 

20,816,064

 

 

$

21

 

 

$

167,682

 

 

$

(129,024

)

 

$

38,679

 

 

 

See accompanying notes.

 

 

 

4


 

Allena Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited)

(in thousands)

 

 

 

Three Months Ended March 31,

 

 

 

2019

 

 

2018

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(11,419

)

 

$

(7,880

)

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

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

629

 

 

 

404

 

Depreciation expense

 

 

40

 

 

 

19

 

Non-cash interest expense

 

 

2

 

 

 

75

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

1,510

 

 

 

612

 

Operating lease assets

 

 

125

 

 

 

 

Other assets

 

 

(144

)

 

 

(42

)

Accounts payable

 

 

534

 

 

 

529

 

Accrued expenses

 

 

(962

)

 

 

(616

)

Operating lease liabilities

 

 

(125

)

 

 

 

Other liabilities

 

 

 

 

 

3

 

Net cash used in operating activities

 

 

(9,810

)

 

 

(6,896

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(84

)

 

 

(31

)

Net cash used in investing activities

 

 

(84

)

 

 

(31

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

13

 

 

 

1

 

Payments of common stock offering costs

 

 

 

 

 

(186

)

Other

 

 

(7

)

 

 

 

Repayment of loan payable

 

 

 

 

 

(1,000

)

Net cash provided by (used in) financing activities

 

 

6

 

 

 

(1,185

)

Net decrease in cash and cash equivalents

 

 

(9,888

)

 

 

(8,112

)

Cash and cash equivalents, beginning of period

 

 

61,643

 

 

 

94,494

 

Cash and cash equivalents, end of period

 

$

51,755

 

 

$

86,382

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures:

 

 

 

 

 

 

 

 

Cash paid in connection with operating lease liabilities

 

$

132

 

 

$

 

Right-of-use assets obtained in exchange of operating lease obligations

 

$

992

 

 

$

 

 

See accompanying notes.

 

 

5

 


 

Allena Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

(in thousands, except share and per share data)

1. Nature of Business

Allena Pharmaceuticals, Inc. (the “Company”) is a late-stage clinical biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. The Company is focused on metabolic disorders that result in excess accumulation of certain metabolites that can cause kidney stones, damage the kidney, and potentially lead to chronic kidney disease (“CKD”), and end-stage renal disease. The Company’s lead product candidate, reloxaliase (formerly known as ALLN-177), is a first-in-class, oral enzyme therapeutic that it is developing for the treatment of hyperoxaluria, a metabolic disorder commonly associated with kidney stones, CKD and other serious kidney diseases. The Company was incorporated under the laws of the State of Delaware on June 24, 2011 and is located in Newton, Massachusetts.

The Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations, reliance on third party manufacturers, ability to transition from pilot-scale manufacturing to large-scale production of products and the need to obtain adequate additional financing to fund the development of its product candidates.

The Company had an accumulated deficit of $129.0 million at March 31, 2019, and will require substantial additional capital to fund operations. The future success of the Company is dependent on its ability to identify and develop its product candidates and ultimately upon its ability to attain profitable operations. At March 31, 2019, the Company had $51.8 million of cash and cash equivalents.  The Company believes that its cash and cash equivalents as of March 31, 2019 will be sufficient to fund the Company’s operating plan through at least the first half of 2020.

2. Summary of Significant Accounting Policies

Basis of Presentation

The Company’s unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations.  Accordingly, these financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2018 and notes thereto, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed with the SEC on March 7, 2019. The unaudited interim consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to present fairly the Company’s financial position as of March 31, 2019, the results of its operations for the three months ended March 31, 2019 and March 31, 2018 and cash flows for the three months ended March 31, 2019 and March 31, 2018. Such adjustments are of a normal and recurring nature. The results for the three months ended March 31, 2019 are not necessarily indicative of the results for the year ending December 31, 2019, or for any future period.

Principles of Consolidation

The consolidated financial statements include the accounts of Allena Pharmaceuticals, Inc. and its wholly owned subsidiaries Allena Pharmaceuticals Security Corporation (“Security Corporation”), which was incorporated in December 2014, and Allena Pharmaceuticals Ireland Limited, which was incorporated in March 2017. All intercompany transactions and balances have been eliminated.

 

6


 

Fair Value of Financial Instruments

Fair value is defined as the price that would be received upon sale of an asset or paid to transfer a liability between market participants at measurement dates. ASC Topic 820, Fair Value Measurement (“ASC 820”), establishes a three-level valuation hierarchy for instruments measured at fair value. The hierarchy is based on the transparency of inputs to the valuation of an asset or liability as of the measurement date. The hierarchy defines three levels of valuation inputs, of which the first two are considered observable and the last is considered unobservable:

 

Level 1

inputs: Quoted prices in active markets for identical assets or liabilities.

 

Level 2

inputs: Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves.

 

Level 3

inputs: Unobservable inputs developed using estimates or assumptions developed by the Company, which reflect those that a market participant would use in pricing the asset or liability.

To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

Leases

ASU No. 2016-02, Leases (Topic 842) (“ASC 842”), became effective January 1, 2019.  As of the effective date of ASC 842, the Company determines at the inception of an arrangement whether the arrangement contains a lease.  If a lease is identified in an arrangement, the Company recognizes a right-of-use asset and liability on its balance sheet and determines whether the lease should be classified as a finance or operating lease.  The Company does not recognize assets or liabilities for leases with lease terms of less than 12 months.

A lease qualifies as a finance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to the Company by the end of the lease term, (ii) the Company holds an option to purchase the leased asset that it is reasonably certain to exercise, (iii) the lease term is for a major part of the remaining economic life of the leased asset, (iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leased asset, (v) the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of the lease term.  All other leases are recorded as operating leases.

Finance and operating lease assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term using the discount rate implicit in the lease.  If the rate implicit is not readily determinable, the Company’s utilizes its incremental borrowing rate at the lease commencement date.  Operating lease assets are further adjusted for prepaid or accrued lease payments.  Operating lease payments are expensed using the straight-line method as an operating expense over the lease term.  Finance lease assets are amortized to depreciation expense using the straight-line method over the shorter of the useful life of the related asset or the lease term.  Finance lease payments are bifurcated into (i) a portion that is recorded as imputed interest expense and (ii) a portion that reduces the finance liability associated with the lease.

The Company separates lease and non-lease components when determining which lease payments to include in the calculation of its lease assets and liabilities.  Variable lease payments are expensed as incurred.  If a lease includes an option to extend or terminate the lease, the Company reflects the option in the lease term if it is reasonably certain it will exercise the option.

Operating leases are recorded in “Operating lease assets,” “Operating lease liabilities” and “Operating lease liabilities, net of current portion” on the Company’s condensed consolidated balance sheet.  The Company did not have any finance leases recorded on its condensed consolidated balance sheet as of March 31, 2019.

The remainder of the Company’s significant accounting policies are described in the Annual Report filed on Form 10-K for the year ended December 31, 2018 that was filed with the United States Securities and Exchange Commission on March 7, 2019.

 

7


 

Recently Adopted Accounting Pronouncements  

In 2016, the FASB issued ASC 842, which amends a number of aspects of lease accounting and requires entities to recognize right-of-use assets and liabilities on the balance sheet.  ASC 842 was effective on January 1, 2019.  In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements (“ASU 2018-11”), which offers a transition option to entities adopting ASC 842.  Under ASU 2018-11, entities can elect to apply ASC 842 using a modified-retrospective adoption approach resulting in a cumulative effect adjustment to accumulated deficit at the beginning of the year in which the new lease standard is adopted, rather than adjustments to the earliest comparative period presented in their financial statements.  The Company adopted ASC 842 using the modified-retrospective method.  

The Company elected the package of transition practical expedients for leases that commenced prior to January 1, 2019, allowing it not to reassess (i) whether any expired or existing contracts contain leases, (ii) the lease classification for any expired or existing leases and (iii) the initial indirect costs for any existing leases.

The Company recorded, upon adoption of ASC 842 on January 1, 2019, right-of-use assets of $1.0 million and corresponding liabilities of $1.0 million related to its operating leases.  The Company did not have any leases at January 1, 2019 that would qualify as finance leases.  These adjustments had no impact on the Company’s consolidated statement of operations and had no impact on the Company’s accumulated deficit.   Refer to Note 6, “Commitments and Contingencies,” for further information regarding the Company’s leases as well as certain disclosures required by ASC 842.

In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. The new standard largely aligns the accounting for share-based payment awards issued to employees and nonemployees by expanding the scope of ASC 718 to apply to nonemployee share-based transactions, as long as the transaction is not effectively a form of financing. The Company adopted ASU 2018-07 on January 1, 2019. The adoption did not have a material impact on the Company’s consolidated financial statements.

Recently Issued Accounting Pronouncements  

In 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (“ASU 2018-15”), which clarifies the accounting for implementation costs in cloud computing arrangements.  The new guidance will become effective for the Company on January 1, 2020.  Early adoption is permitted.  The Company is currently evaluating the impact the adoption of ASU 2018-15 will have on its consolidated financial statements.

In 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which modifies the disclosure requirements on fair value measurements.  The new guidance will become effective for the Company on January 1, 2020.  Early adoption is permitted.  The Company currently is evaluating the impact the adoption of ASU 2018-13 will have on its disclosures.

 

 

3. Net Loss per Share

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. The Company has computed diluted net loss per common share after giving consideration to all potentially dilutive common shares, including options to purchase common stock, restricted common stock, convertible preferred stock and warrants to purchase convertible preferred stock, outstanding during the period determined using the treasury-stock and if-converted methods, except where the effect of including such securities would be antidilutive. Because the Company has reported net losses since inception, these potential common shares have been anti-dilutive and basic and diluted loss per share have been the same.

 

8


 

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share data):

 

 

 

Three Months Ended March 31,

 

 

 

2019

 

 

2018

 

Numerator:

 

 

 

 

 

 

 

 

Net loss

 

$

(11,419

)

 

$

(7,880

)

Net loss attributable to common stockholders

 

$

(11,419

)

 

$

(7,880

)

Denominator:

 

 

 

 

 

 

 

 

Weighted-average common shares—basic and diluted

 

 

20,814,715

 

 

 

20,695,386

 

Net loss per share attributable to common

   stockholders—basic and diluted

 

$

(0.55

)

 

$

(0.38

)

 

The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to include them would be anti-dilutive (in common stock equivalent shares):

 

 

 

Three Months Ended March 31,

 

 

 

2019

 

 

2018

 

Warrants

 

 

9,040

 

 

 

9,040

 

Stock options

 

 

2,956,726

 

 

 

2,043,924

 

Total

 

 

2,965,766

 

 

 

2,052,964

 

 

4. Fair Value Measurements

The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value at March 31, 2019 and December 31, 2018, and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands):

 

Description

 

March 31,

2019

 

 

Quoted

Prices

in Active

Markets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds, included in cash and cash equivalents

 

$

51,655

 

 

$

51,655

 

 

$

 

 

$

 

Total assets

 

$

51,655

 

 

$

51,655

 

 

$

 

 

$

 

 

Description

 

December 31,

2018

 

 

Quoted

Prices

in Active

Markets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds, included in cash and cash equivalents

 

$

61,415

 

 

$

61,415

 

 

$

 

 

$

 

Total assets

 

$

61,415

 

 

$

61,415

 

 

$

 

 

$

 

 

At March 31, 2019 and December 31, 2018, all of the Company’s cash equivalents were comprised of money market funds.

There were no changes to the valuation methods during the three months ended March 31, 2019 and the year ended December 31, 2018. There were no transfers within the fair value hierarchy during the three months ended March 31, 2019 and the year ended December 31, 2018.

The carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their carrying values. The Company believes the terms of the loan payable reflect current market conditions for an instrument with similar termsc and maturity, therefore the carrying value of the Company’s debt approximates its fair value based on Level 3 of the fair value hierarchy.

 

9


 

5. Accrued Expenses

Accrued expenses consist of the following (in thousands):

 

 

 

March 31,

2019

 

 

December 31,

2018

 

Payroll and employee-related expenses

 

$

866

 

 

$

1,690

 

Third-party research and development expenses

 

 

1,256

 

 

 

1,514

 

Professional fees

 

 

359

 

 

 

299

 

Loan interest

 

 

47

 

 

 

46

 

Other

 

 

142

 

 

 

76

 

Total accrued expenses

 

$

2,670

 

 

$

3,625

 

 

6. Commitments and Contingencies

The Company is a party to operating leases for approximately 7,795 square feet of office space in Newton, MA (Newton Lease), and for approximately 7,564 square feet of laboratory and office space in Sudbury, MA (Sudbury Lease).  The Newton Lease expires on December 31, 2020 and the Sudbury Lease expires on February 28, 2021.  Annualized base rent for the Newton Lease and the Sudbury lease is approximately $0.3 million and $0.2 million, respectively.

Aggregate Lease Information Related to the Application of ASC 842

Maturities of the Company’s operating lease liabilities in accordance with ASC 842 as of March 31, 2019 are as follows (in thousands):

 

Remainder of 2019

 

$

356

 

2020

 

 

539

 

2021

 

 

29

 

Total maturities

 

 

924

 

Less: Amount representing interest

 

 

(50

)

Present value of operating lease liabilities

 

$

874

 

 

Lease costs included in the Company’s condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2019 was $0.1 million.  The Company’s operating leases had a weighted average remaining lease term of 1.7 years and a weighted average discount rate of 5.5% at March 31, 2019.

Additional Lease Information Related to the Application of ASC 840

The following information is disclosed in accordance with ASC 840, Leases (Topic 840) (“ASC 840”), which was applicable until December 31, 2018.  As of December 31, 2018, future minimum commitments under the Company’s operating leases with initial terms of more than one year were as follows (in thousands):

 

 

 

December 31,

2018

 

2019

 

$

487

 

2020

 

 

539

 

2021

 

 

30

 

 

 

$

1,056

 

 

During the three months ended March 31, 2018, rent expense was $0.1 million.

 

10


 

7. Loan and Security Agreement

In August 2014, the Company entered into a Loan Agreement with Silicon Valley Bank (“SVB”) and borrowed $7.0 million under the loan.  In May 2016, the Loan Agreement was amended (“Amended Loan Agreement”) to borrow up to $10.0 million with a portion of the proceeds to be used to pay down the outstanding balance of the original $7.0 million of advances. At the time of the Amended Loan Agreement, SVB advanced a gross amount of $7.5 million to the Company. Net proceeds received by the Company were $1.6 million after deducting $5.3 million for repayment of the original advances and $0.6 million for final interest due upon maturity or prepayment of the original advances. In December 2016, upon the achievement of certain milestones, SVB advanced the remaining $2.5 million available under the Amended Loan Agreement.    

The borrowings were secured by a lien on all Company assets, excluding intellectual property. The May 2016 and December 2016 advances had a floating per annum interest rate equal to the greater of 4.0% or 0.5% above the prime rate. In December 2016, the interest only period was extended to 18 months. Upon the expiration of the interest only period, amounts borrowed were to be repaid over 30 equal monthly payments of principal and interest. At its option, the Company could prepay all, but not less than all, of the outstanding borrowings subject to a prepayment premium as defined in the Amended Loan Agreement. The Company was also required to make a final payment equal to 8.25% of the total borrowings (“Final Payment”) on the earliest of the loan maturity date, an acceleration of the loan as defined in the Amended Loan Agreement or at the time of prepayment.   

On June 29, 2018 the Company also entered into a loan agreement with Pacific Western Bank (“PWB Loan Agreement”) providing up to $12.0 million of borrowings, of which $10.0 million was advanced on June 29, 2018.  The remaining $2.0 million of borrowings available under the PWB Loan Agreement are available to the Company through one additional advance request until the end of the interest only period as defined below.  Borrowings are secured by a lien on all Company assets, excluding intellectual property, and amounts borrowed have a floating per annum interest rate of the greater of 5.0% or the prime rate.  The PWB Loan Agreement has a term of 48 months and an initial interest only period of 18 months.  If the Company receives at least $50M of gross proceeds from the sale of its equity securities or upfront cash payment from a strategic partnership prior the expiration of the initial interest only period, the interest only period will be extended an additional six months.  Upon the expiration of the initial interest only period on December 31, 2019, amounts borrowed will be repaid over 30 equal monthly payments of principal plus accrued but unpaid interest. If the interest only period is extended an additional six months, amounts borrowed will be repaid over 24 equal monthly payments of principal plus accrued but unpaid interest beginning July 1, 2020.  At its option, the Company may prepay all, but not less than all, of the outstanding borrowings subject to a prepayment premium as defined in the Loan Agreement.  Upon the closing of one or more financings, in which the Company receives aggregate gross proceeds of at least $25 million, a success fee will be paid to the Lender.  If the gross proceeds are received on or before June 30, 2019, the Success Fee is $200,000, and f the gross proceeds are received after June 30, 2019, the Success Fee is $300,000.  The Company’s obligation to pay this Success Fee survives termination of the Agreement.

The PWB Loan Agreement contains negative covenants restricting the Company’s activities, including limitations on dispositions, mergers or acquisitions, incurring indebtedness or liens, paying dividends or making investments and certain other business transactions. There are no financial covenants associated with the PWB Loan Agreement. The obligations under the PWB Loan Agreement are subject to acceleration upon the occurrence of specified events of default, including a material adverse change in the Company’s business, operations or financial or other condition. The Company has determined that the risk of subjective acceleration under the material adverse events clause is remote and therefore has classified the outstanding principal based on scheduled principal payments.

The Company evaluated the PWB Loan Agreement for embedded features that require bifurcation, noting certain features were required to be bifurcated, but were concluded to be de minimis in value at March 31, 2019 and December 31, 2018.

 

8. Stockholders’ Deficit

Common Stock

The holders of common stock are entitled to one vote for each share held. Common stockholders are not entitled to receive dividends, unless declared by the Board of Directors.

 

11


 

The Company has reserved for future issuances the following shares of common stock as of March 31, 2019 and December 31, 2018:

 

 

 

March 31,

2019

 

 

December 31,

2018

 

Warrants

 

 

9,040

 

 

 

9,040

 

Stock options

 

 

5,087,663

 

 

 

4,262,341

 

Employee stock purchase plan

 

 

405,742

 

 

 

405,742

 

Total

 

 

5,502,445

 

 

 

4,677,123

 

 

9. Stock Incentive Plan    

On October 31, 2017, the Company adopted the 2017 Stock Option and Incentive Plan (“2017 Plan”).  Upon the adoption of the 2017 Plan, no further grants would be made under the 2011 Stock Incentive Plan (“2011 Plan”).  The 2017 Plan initially provided for the grant of awards for 2,038,021 shares of common stock.  In addition to the shares available for grant under the 2017 Plan, any awards outstanding under the 2011 Plan as of the October 31, 2017 are cancelled, forfeited or otherwise terminated without being exercised, the number of shares underlying such awards will be available for future grant under the 2017 Plan. The 2017 Plan also provides that an additional number of shares will automatically be added to the shares authorized for issuance under the 2017 Plan on January 1 of each year. The number of shares added each year will be equal to the lesser of: (i) 4% of the outstanding shares on the immediately preceding December 31 or (ii) such amount as determined by the Compensation Committee of the registrant’s Board of Directors.  On January 1, 2018, the shares available for grant under the 2017 Plan was automatically increased by 827,786 shares.  On January 1, 2019, the shares available for grant under the 2017 Plan was automatically increased by an additional 832,361 shares.

All of the Company’s employees, officers, directors, consultants and advisors are eligible to be granted options, restricted stock units (“RSUs”), and other share-based awards under the terms of the 2017 Plan.  As of March 31, 2019, 2,130,937 shares of common stock were available for future grant under the 2017 Plan.

All stock option grants are nonstatutory stock options except option grants to employees (including officers and directors) intended to qualify as incentive stock options under the Internal Revenue Code of 1986, as amended. Incentive stock options may not be granted at less than the fair market value of the Company’s common stock on the date of grant, as determined in good faith by the Board of Directors at its sole discretion. Nonqualified stock options may be granted at an exercise price established by the Board of Directors at its sole discretion (which has not been less than fair market value on the date of grant) and the vesting periods may vary. Vesting periods are generally four years and are determined by the Board of Directors or a delegated subcommittee. Stock options become exercisable as they vest. Options granted under both the 2011 Plan and 2017 Plan expire no more than 10 years from the date of grant.

Stock-based compensation expense included in the Company’s statements of operations and comprehensive loss is as follows (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2019

 

 

2018

 

Research and development

 

$

255

 

 

$

90

 

General and administrative

 

 

374

 

 

 

314

 

Total

 

$

629

 

 

$

404

 

 

The fair value of each stock option granted to employees and directors was estimated on the date of grant using the Black-Scholes option-pricing model, with the following range of assumptions as follows:

 

 

 

Three Months Ended March 31,

 

 

2019

 

2018

Risk-free interest rate

 

2.5%-2.6%

 

2.3%-2.7%

Expected dividend yield

 

—%

 

—%

Expected term (in years)

 

5.8-6.8

 

5.9-6.1

Expected volatility

 

82%

 

81%-89%

 

 

12


 

A summary of the stock option activity under the 2011 and 2017 Plans is as follows:

 

 

 

Shares

 

 

Weighted-

Average

Exercise

Price

 

 

Weighted-

Average

Remaining

Contractual

Life

(in years)

 

 

Aggregate

Intrinsic

Value

(in thousands)

 

Outstanding at December 31, 2018

 

 

2,141,527

 

 

 

4.32

 

 

 

7.7

 

 

$

4,959

 

Granted

 

 

825,250

 

 

 

6.84

 

 

 

 

 

 

 

 

 

Exercised

 

 

(7,039

)

 

 

1.85

 

 

 

 

 

 

 

 

 

Cancelled

 

 

(3,012

)

 

 

8.54

 

 

 

 

 

 

 

 

 

Outstanding at March 31, 2019

 

 

2,956,726

 

 

$

5.02

 

 

 

8.2

 

 

$

7,239

 

Exercisable at March 31, 2019

 

 

1,274,158

 

 

$

2.34

 

 

 

6.7

 

 

$

6,046

 

As of March 31, 2019, total unrecognized stock-based compensation expense relating to unvested stock options was $7.7 million. This amount is expected to be recognized over a weighted-average period of 3.2 years.

 

 

13


 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2018 that was filed with the United States Securities and Exchange Commission, or the SEC, on March 7, 2019.

Our actual results and timing of certain events may differ materially from the results discussed, projected, anticipated, or indicated in any forward-looking statements. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report, they may not be predictive of results or developments in future periods. 

The following information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Quarterly Report on Form 10-Q, including those risks identified under Part II, Item 1A. Risk Factors.

We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Overview

We are a late-stage, clinical biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. We are focused on metabolic disorders that result in excess accumulation of certain metabolites that can cause kidney stones, damage the kidney, and potentially lead to chronic kidney disease, or CKD, and end-stage renal disease. Our lead product candidate, reloxaliase (formerly known as ALLN-177), is a first-in-class, oral enzyme therapeutic that we are developing for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, CKD and other serious kidney diseases. There are currently no approved therapies for the treatment of hyperoxaluria.

We have conducted a robust clinical development program of reloxaliase, including three Phase 2 clinical trials, which demonstrated reductions of urinary oxalate excretion in patients with secondary hyperoxaluria, particularly in patients with enteric hyperoxaluria. Reloxaliase has also been well tolerated in clinical trials to date. Based on these data, the high unmet medical need, the enzymes specific mechanism of action, and the significant market opportunity, we are initially developing reloxaliase for adult patients with enteric hyperoxaluria.

In March 2018, we initiated URIROX-1TM (URIROX-1) (formerly Study 301), the first of our two anticipated Phase 3 clinical trials in support of our planned Biologic License Application, or BLA, for reloxaliase in patients with enteric hyperoxaluria. Based on our enrollment progress to date, we expect to announce topline data from this trial in the second half of 2019. In the fourth quarter of 2018, we initiated URIROX-2 (formerly Study 302), our second pivotal Phase 3 trial of reloxaliase in patients with enteric hyperoxaluria.  The FDA has advised us that it agrees with our strategy to pursue a BLA submission for reloxaliase using the accelerated approval regulatory pathway. We expect to submit a BLA filing to the FDA after 400 patients have been randomized and followed for six months in URIROX-2. For the long-term follow-up phase of the trial, subjects would continue in URIROX-2 for a minimum treatment period of two years to confirm clinical benefit post-approval.  

In addition to our Phase 3 program of reloxaliase for enteric hyperoxaluria, we are also evaluating reloxaliase in Study 206, a Phase 2 basket trial in adults and adolescents with primary hyperoxaluria or enteric hyperoxaluria with hyperoxalemia, which we initiated in March 2018.  We expect to announce initial data from Study 206 in the second quarter of 2019 and topline data from this trial in the second half of 2019.

 

14


 

In addition, we have designed our second product candidate, ALLN-346, an orally administered, novel, urate degrading enzyme, for patients with hyperuricemia and gout in the setting of advanced CKD. Hyperuricemia, or elevated levels of uric acid in the blood, results from overproduction or insufficient excretion of urate, or often a combination of the two. ALLN-346 has demonstrated a robust reduction in both plasma and urine uric acid levels in an established urate oxidase knock-out mouse model, a severe animal model of hyperuricemia with advanced CKD and kidney damage due to urate crystal deposition. We presented preclinical data for ALLN-346 in October at the 2018 American College of Rheumatology (ACR/ARHP) Annual Meeting.  We are advancing our preclinical program for ALLN-346 and scaling our manufacturing processes for clinical studies. Subject to the successful completion of these activities, we expect to file an IND for ALLN-346 with the FDA in the second half of 2019 and to initiate our first clinical trial of ALLN-346 in patients with hyperuricemia in the first half of 2020.

On November 6, 2017, we completed our initial public offering, or IPO, in which we issued and sold 5,333,333 shares of our common stock at a public offering price of $14.00 per share, for aggregate gross proceeds of $74.7 million. The underwriters partially exercised their over-allotment option on December 1, 2017, and purchased 16,969 shares of our common stock, for aggregate gross proceeds of $0.2 million.  As a result of the IPO, we received approximately $67.0 million in net proceeds after deducting $7.9 million of underwriting discounts and commissions and offering costs.

Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, developing our technology, identifying potential product candidates, producing drug substance and drug product material for use in preclinical studies and clinical trials, and conducting preclinical studies of our product candidates and clinical trials for our lead product candidate, reloxaliase. We do not have any products approved for sale and have not generated any revenue to date. As of March 31, 2019, we had cash and cash equivalents totaling $51.8 million.

We have incurred significant net operating losses in every year since our inception and expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and year to year. Our net losses were $11.4 million and $7.9 million for the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019, we had an accumulated deficit of $129.0 million. We anticipate that our expenses will increase significantly as we:

 

conduct future clinical trials of our lead product candidate, reloxaliase;

 

manufacture additional material for our pivotal Phase 3 clinical program and potential future clinical studies we might conduct for our product candidates;

 

scale up our manufacturing process for reloxaliase to prepare for the filing of a potential BLA and commercialization if our clinical development program is successful;

 

advance the development of ALLN-346;

 

conduct research on the discovery and development of additional product candidates;

 

seek regulatory and marketing approvals for product candidates that successfully complete clinical trials, if any;

 

establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain regulatory approval in geographies in which we plan to commercialize our products ourselves;

 

maintain, expand and protect our intellectual property portfolio;

 

hire additional staff, including clinical, scientific, technical, operational, and financial personnel, to execute our business plan; and

 

add clinical, scientific, operational, financial and management information systems to support our product development and potential future commercialization efforts, and to enable us to operate as a public company.

We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for a product candidate. Additionally, we currently use contract research organizations, or CROs, and contract manufacturing organizations, or CMOs, to carry out our preclinical and clinical development activities. We do not yet have a sales organization. If we obtain regulatory approval for our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, we may seek to fund our operations through public or private equity or debt financings or other sources, including strategic collaborations. We may, however, be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial condition and our ability to develop our current product candidates, or any additional product candidates, if developed.

 

15


 

Financial Operations Overview

Revenue

To date, we have not generated any revenue from product sales or any other source and do not expect to generate any revenue from the sale of products for the foreseeable future. If our development efforts for reloxaliase or other product candidates that we may develop in the future are successful and result in marketing approval or collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such collaboration or license agreements.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including our drug discovery efforts and the development of our product candidates, which include:

 

employee-related expenses, including salaries, benefits and stock-based compensation expense;

 

costs incurred under agreements with third parties, including CROs, that conduct research and development, preclinical studies and clinical trials on our behalf;

 

costs related to production of preclinical and clinical materials, including fees paid to CMOs;

 

consulting, licensing and professional fees related to research and development activities;

 

costs of purchasing laboratory supplies and non-capital equipment used in our research and development activities;

 

costs related to compliance with clinical regulatory requirements; and

 

facility costs and other allocated expenses, which include expenses for rent and maintenance of facilities, insurance, depreciation and other supplies.

We expense research and development costs as incurred. We recognize costs for certain development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as clinical site activations, patient enrollment, or information provided to us by our vendors and our clinical investigative sites. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and may be reflected in our consolidated financial statements as prepaid or accrued research and development expenses. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized, even when there is no alternative future use for the research and development. The capitalized amounts are expensed as the related goods are delivered or the services are performed.

The following summarizes our most advanced current research and development programs:

 

reloxaliase is our lead product candidate which we are developing for the treatment of hyperoxaluria. Substantially all of our research and development costs to date have been used to fund this program.

 

ALLN-346 is our second product candidate which we are developing for patients with hyperuricemia and CKD. We began incurring external research and development costs for this program in 2016.

We typically use our employee and infrastructure resources across our development programs. We track outsourced development costs by product candidate or development program, but we do not allocate personnel costs and other internal costs to specific product candidates or development programs.

The following table summarizes our research and development expenses by program (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2019

 

 

2018

 

Reloxaliase external costs

 

$

4,825

 

 

$

4,135

 

ALLN-346 external costs

 

 

1,113

 

 

 

71

 

Employee compensation and benefits

 

 

2,519

 

 

 

1,450

 

Other

 

 

671

 

 

 

275

 

Total research and development expenses

 

$

9,128

 

 

$

5,931

 

 

 

16


 

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. Since inception, we have incurred $69.8 million of external research and development costs for reloxaliase and $3.5 million of external research and development costs for ALLN-346. We expect that our research and development costs will continue to increase for the foreseeable future as we conduct and initiate additional clinical trials of reloxaliase, scale our manufacturing processes and advance development of ALLN-346.

The successful development of reloxaliase, ALLN-346 and other potential future product candidates is highly uncertain. Accordingly, at this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the development of these product candidates. We are also unable to predict when, if ever, we will generate revenue and material net cash inflows from the commercialization and sale of any of our product candidates for which we may obtain marketing approval. We may never succeed in achieving regulatory approval for any of our product candidates. The duration, costs and timing of preclinical studies, clinical trials and development of our product candidates will depend on a variety of factors, including:

 

successful enrollment in, and completion of, clinical trials for reloxaliase;

 

successful data from our clinical program of reloxaliase that supports an acceptable benefit-risk profile of reloxaliase in the intended populations;

 

establishing an appropriate safety profile for ALLN-346 and any potential future product candidate with studies to enable the filing of an investigational new drug application;

 

approval of INDs for ALLN-346 and any potential future product candidate to commence planned or future clinical trials;

 

significant and changing government regulation and regulatory guidance;

 

timing and receipt of marketing approvals from applicable regulatory authorities;

 

making arrangements with CMOs for third-party commercial manufacturing of our product candidates;

 

obtaining and maintaining patent and other intellectual property protection and regulatory exclusivity for our product candidates;

 

commercializing the product candidates, if and when approved, whether alone or in collaboration with others;

 

acceptance of the product, if and when approved, by patients, the medical community and third-party payors; and

 

maintenance of a continued acceptable safety profile of the drugs following approval.

A change in the outcome of any of these variables with respect to the development, manufacture or commercialization enabling activities of any of our product candidates could mean a significant change in the costs, timing and viability associated with the development of that product candidate.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, accounting, business development and human resources functions. Other significant costs include facility costs not otherwise included in research and development expenses, legal fees relating to patent and corporate matters and professional fees for accounting, auditing, tax and consulting services.

We expect that our general and administrative expenses will increase in the future to support continued research and development activities and potential commercialization of our product candidates. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, attorneys and accountants, among other expenses.

Interest Income (Expense), Net

Interest income (expense), net, primarily consists of interest income earned on our cash and cash equivalents, and interest expense incurred on our credit facility, amortized debt discount related to the fair value of the warrants issued in conjunction with the advances under the credit facility and debt issuance costs.

 

17


 

Other Income (Expense), Net

Other income (expense), net, primarily consists of gain (loss) on foreign currency transactions.

Critical Accounting Policies and Use of Estimates

Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience, known trends and events, and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates under different assumptions or conditions.  There have been no changes to our critical accounting policies appearing in the Annual Report filed on Form 10-K for the year ended December 31, 2018.

Our significant accounting policies are described in detail in the notes to our consolidated financial statements appearing in the Annual Report filed on Form 10-K for the year ended December 31, 2018. There have been no changes to our significant accounting policies, other than our significant accounting policy for leases described in the notes to the condensed consolidated financial statements appearing in this Quarterly Report filed on Form 10-Q.

Results of Operations

Comparison of the three months ended March 31, 2019 and 2018

The following table summarizes our results of operations for the three months ended March 31, 2019 and 2018 (in thousands):

 

 

 

Three Months Ended March 31,

 

 

Dollar

 

 

 

2019

 

 

2018

 

 

Change

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

9,128

 

 

$

5,931

 

 

$

3,197

 

General and administrative

 

 

2,431

 

 

 

2,042

 

 

 

389

 

Total operating expenses

 

 

11,559

 

 

 

7,973

 

 

 

3,586

 

Loss from operations

 

 

(11,559

)

 

 

(7,973

)

 

 

(3,586

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

151

 

 

 

100

 

 

 

51

 

Other expense, net

 

 

(11

)

 

 

(7

)

 

 

(4

)

Other income (expense), net

 

 

140

 

 

 

93

 

 

 

47

 

Net loss

 

$

(11,419

)

 

$

(7,880

)

 

$

(3,539

)

Research and Development Expense

Research and development expense increased by $3.2 million from $5.9 million for the three months ended March 31, 2018 to $9.1 million for the three months ended March 31, 2019. The following table summarizes our research and development expenses for the three months ended March 31, 2019 and 2018 (in thousands):

 

 

 

Three Months Ended March 31,

 

 

Dollar

 

 

 

2019

 

 

2018

 

 

Change

 

Clinical development external costs

 

$

3,614

 

 

$

2,260

 

 

$

1,354

 

Manufacturing external costs

 

 

2,423

 

 

 

1,514

 

 

 

909

 

Employee compensation and benefits

 

 

2,519

 

 

 

1,450

 

 

 

1,069

 

Other

 

 

572

 

 

 

707

 

 

 

(135

)

Total research and development expenses

 

$

9,128

 

 

$

5,931

 

 

$

3,197

 

 

 

18


 

The $3.2 million increase in research and development expense was primarily attributable to the following:

 

Our clinical development external costs increased by $1.4 million from $2.3 million for the three months ended March 31, 2018 to $3.6 million for the three months ended March 31, 2019:

 

o

The increase is primarily due to URIROX-2 Study expenses of $1.5 million for the three months ended March 31, 2019.  We initiated this study in the fourth quarter of 2018. ;

 

o

We also incurred costs of $1.5 million for the URIROX-1 Study for both the three months ended March 31, 2019 and 2018.  This study was initiated during the three months ended March 31, 2018; and

 

o

We incurred $0.4 million and $0.3 million of costs for our 206 Study during the three months ended March 31, 2019 and 2018, respectively.  This study was also initiated during the three months ended March 31, 2018.

 

Our manufacturing external costs increased by $0.9 million from $1.5 million for the three months ended March 31, 2018 to $2.4 million for the three months ended March 31, 2019.  Included in manufacturing costs for the three months ended March 31, 2019 was $1.0 million of formulation and development costs for ALLN-346.  We did not incur any manufacturing related costs for ALLN-346 during the three months ended March 31, 2018.  Partially offsetting this increase was a decrease of $0.1 million related to drug substance and drug product formulation and development activities associated with reloxaliase for the three months ended March 31, 2019 as compared to the three months ended March 31, 2018; and

 

Our employee compensation and benefits costs increased by $1.1 million for the three months ended March 31, 2019, primarily due to an increase in headcount from 28 employees at March 31, 2018 to 41 employees at March 31, 2019, which resulted in an increase in salaries, wages and benefit costs.

General and Administrative Expenses

General and administrative expense increased by $0.4 million from $2.0 million for three months ended March 31, 2018 to $2.4 million for the three months ended March 31, 2019. The following table summarizes our general and administrative expenses for the three months ended March 31, 2019 and 2018 (in thousands):

 

 

 

Three Months Ended March 31,

 

 

Dollar

 

 

 

2019

 

 

2018

 

 

Change

 

Employee compensation and benefits

 

$

1,090

 

 

$

1,003

 

 

$

87

 

Consulting and professional services

 

 

773

 

 

 

516

 

 

 

257

 

Market research and commercialization planning

 

 

176

 

 

 

103

 

 

 

73

 

Other

 

 

392

 

 

 

420

 

 

 

(28

)

Total general and administrative expenses

 

$

2,431

 

 

$

2,042

 

 

$

389

 

The increase in general and administrative expense was primarily attributable to the following:

 

Our consulting and professional services costs increased by $0.3 million. The increase was primarily related to increased costs for investor and public relations activities, consulting costs and accounting and tax preparation fees; and

 

Our market research and commercialization planning costs increased by $0.1 million.  During the three months ended March 31, 2019, we initiated a study with an independent third party to perform a market assessment for enteric hyperoxaluria.

Interest Income (Expense), net

Interest income (expense), net consists of interest income earned on our cash and cash equivalents and interest expense charged on our outstanding debt. We had net interest income of $0.2 million and $0.1 million for the three months ended March 31, 2019 and 2018, respectively. The increase was attributable to a reduction of interest expense for the three months ended March 31, 2019 as a result of refinancing our outstanding debt during the second quarter of 2018.

 Liquidity and Capital Resources

Sources of Liquidity

We have funded our operations from inception through March 31, 2019 through gross proceeds of $96.0 million from sales of our convertible preferred stock, borrowings of $10.0 million under our credit facilities and net proceeds from our IPO of $67.0 million which was completed in November 2017. Our total cash and cash equivalents was $51.8 million at March 31, 2019.

 

19


 

Cash Flows

The following table provides information regarding our cash flows for the three months ended March 31, 2019 and 2018 (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2019

 

 

2018

 

Net cash used in operations

 

$

(9,810

)

 

$

(6,896

)

Net cash used in investing activities

 

 

(84

)

 

 

(31

)

Net cash provided by (used in) financing activities

 

 

6

 

 

 

(1,185

)

Net decrease in cash and cash equivalents

 

$

(9,888

)

 

$

(8,112

)