10-Q 1 alt-10q_20190630.htm ALT Q2 2019 10Q alt-10q_20190630.htm

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 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 001-32587

 

Altimmune, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

 

20-2726770

State or Other Jurisdiction of

Incorporation or Organization

 

I.R.S. Employer

Identification No.

 

910 Clopper Road Suite 201S, Gaithersburg, Maryland

 

20878

Address of Principal Executive Offices

 

Zip Code

 

(240) 654-1450

Registrant’s Telephone Number, Including Area Code

Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report

 

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

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock, par value $0.0001 per share

ALT

The NASDAQ Global 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.

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

Smaller reporting company

Emerging growth company

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes      No  

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: as of August 13, 2019 there were 15,338,001 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.

 

 

 


 

 

 

ALTIMMUNE, INC.

TABLE OF CONTENTS

 

 

 

 

Page

 

 

 

 

PART I — FINANCIAL INFORMATION

 

 

 

 

 

 

 

Item 1. Consolidated Financial Statements (Unaudited)

 

 

 

 

 

 

 

     Consolidated Balance Sheets

 

1

 

     Consolidated Statements of Operations and Comprehensive Loss

 

2

 

     Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity

 

3

 

     Consolidated Statements of Cash Flows

 

5

 

     Notes to Consolidated Financial Statements

 

6

 

 

 

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

13

 

 

 

 

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

17

 

 

 

 

 

Item 4. Controls and Procedures

 

17

 

 

 

 

PART II — OTHER INFORMATION

 

18

 

 

 

 

 

Item 1. Legal Proceedings

 

18

 

 

 

 

 

Item 1A. Risk Factors

 

18

 

 

 

 

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

18

 

 

 

 

 

Item 3. Defaults Upon Senior Securities

 

18

 

 

 

 

 

Item 4. Mine Safety Disclosures

 

18

 

 

 

 

 

Item 5. Other Information

 

18

 

 

 

 

 

Item 6. Exhibits

 

19

 

 

 

i


 

 

Part I—FINANCIAL INFORMATION

Item 1.

Consolidated Financial Statements (Unaudited).

ALTIMMUNE, INC.

CONSOLIDATED BALANCE SHEETS

(unaudited)

 

 

 

June 30, 2019

 

 

December 31, 2018

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

41,671,738

 

 

$

33,718,713

 

Restricted cash

 

 

34,174

 

 

 

634,416

 

Total cash, cash equivalents and restricted cash

 

 

41,705,912

 

 

 

34,353,129

 

Accounts receivable

 

 

2,629,840

 

 

 

3,461,938

 

Tax refund receivable

 

 

1,080,559

 

 

 

1,008,973

 

Prepaid expenses and other current assets

 

 

688,862

 

 

 

548,094

 

Total current assets

 

 

46,105,173

 

 

 

39,372,134

 

Property and equipment, net

 

 

1,222,130

 

 

 

1,342,802

 

Right of use asset

 

 

732,380

 

 

 

 

Intangible assets, net

 

 

13,760,216

 

 

 

13,851,924

 

Other assets

 

 

156,115

 

 

 

183,682

 

Total assets

 

$

61,976,014

 

 

$

54,750,542

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Notes payable

 

$

163,724

 

 

$

71,596

 

Accounts payable

 

 

270,097

 

 

 

372,860

 

Accrued expenses and other current liabilities

 

 

3,046,567

 

 

 

4,082,949

 

Total current liabilities

 

 

3,480,388

 

 

 

4,527,405

 

Deferred income taxes

 

 

58,500

 

 

 

58,500

 

Other long-term liabilities

 

 

2,212,104

 

 

 

1,852,071

 

Total liabilities

 

 

5,750,992

 

 

 

6,437,976

 

Commitments and contingencies (Note 12)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 shares authorized;

   13,451,106 and 9,078,735 shares issued; 13,450,751 and 9,078,238 shares

  outstanding at June 30, 2019 and December 31, 2018, respectively

 

 

1,313

 

 

 

876

 

Additional paid-in capital

 

 

183,604,057

 

 

 

170,207,844

 

Accumulated deficit

 

 

(122,340,185

)

 

 

(116,855,991

)

Accumulated other comprehensive loss – foreign currency translation

   adjustments

 

 

(5,040,163

)

 

 

(5,040,163

)

Total stockholders’ equity

 

 

56,225,022

 

 

 

48,312,566

 

Total liabilities and stockholders’ equity

 

$

61,976,014

 

 

$

54,750,542

 

 

The accompanying notes are an integral part of the unaudited consolidated financial statements.

1


 

 

ALTIMMUNE, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

 

 

 

For the Three Months Ended

June 30,

 

 

For the Six Months Ended

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

1,626,029

 

 

$

2,417,140

 

 

$

4,581,622

 

 

$

5,108,121

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

2,945,096

 

 

 

4,918,961

 

 

 

6,162,768

 

 

 

10,665,890

 

General and administrative

 

 

2,231,817

 

 

 

2,933,982

 

 

 

4,298,299

 

 

 

5,381,917

 

Impairment charges

 

 

 

 

 

 

 

 

 

 

 

490,676

 

Total operating expenses

 

 

5,176,913

 

 

 

7,852,943

 

 

 

10,461,067

 

 

 

16,538,483

 

Loss from operations

 

 

(3,550,884

)

 

 

(5,435,803

)

 

 

(5,879,445

)

 

 

(11,430,362

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Changes in fair value of warrant liability

 

 

(46,000

)

 

 

(5,228,691

)

 

 

(46,000

)

 

 

(3,680,709

)

Changes in fair value of embedded derivatives

 

 

 

 

 

4,912

 

 

 

 

 

 

(2,130

)

Interest expense

 

 

(748

)

 

 

(1,921

)

 

 

(1,488

)

 

 

(2,791

)

Interest income

 

 

239,964

 

 

 

25,617

 

 

 

425,211

 

 

 

57,206

 

Other income (expense)

 

 

(29,220

)

 

 

(49

)

 

 

17,528

 

 

 

257,675

 

Total other income (expense)

 

 

163,996

 

 

 

(5,200,132

)

 

 

395,251

 

 

 

(3,370,749

)

Net loss before income tax benefit

 

 

(3,386,888

)

 

 

(10,635,935

)

 

 

(5,484,194

)

 

 

(14,801,111

)

Income tax benefit

 

 

 

 

 

1,497,093

 

 

 

 

 

 

2,488,731

 

Net loss

 

 

(3,386,888

)

 

 

(9,138,842

)

 

 

(5,484,194

)

 

 

(12,312,380

)

Other comprehensive income (loss) – foreign currency translation adjustments

 

 

 

 

 

(1,078,648

)

 

 

 

 

 

(463,177

)

Comprehensive loss

 

$

(3,386,888

)

 

$

(10,217,490

)

 

$

(5,484,194

)

 

$

(12,775,557

)

Net loss

 

$

(3,386,888

)

 

$

(9,138,842

)

 

$

(5,484,194

)

 

$

(12,312,380

)

Preferred stock accretion and other deemed dividends

 

 

 

 

 

(700,093

)

 

 

(452,925

)

 

 

(2,591,414

)

Net loss attributed to common stockholders

 

$

(3,386,888

)

 

$

(9,838,935

)

 

$

(5,937,119

)

 

$

(14,903,794

)

Weighted-average common shares outstanding, basic and diluted

 

 

13,127,773

 

 

 

956,057

 

 

 

11,318,819

 

 

 

817,077

 

Net loss per share attributed to common stockholders, basic and diluted

 

$

(0.26

)

 

$

(10.29

)

 

$

(0.52

)

 

$

(18.24

)

 

The accompanying notes are an integral part of the unaudited consolidated financial statements.

 

 

2


 

 

ALTIMMUNE, INC.

CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY

(unaudited)

 

 

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Accumulated

Other

Comprehensive

 

 

Total

Stockholders’

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance, January 1, 2019

 

 

 

 

 

 

9,078,239

 

 

$

876

 

 

$

170,207,844

 

 

$

(116,855,991

)

 

$

(5,040,163

)

 

$

48,312,566

 

Stock based compensation and vesting of restricted stock

 

 

 

 

 

 

71

 

 

 

 

 

 

 

407,742

 

 

 

 

 

 

 

 

 

 

 

407,742

 

Issuance of common stock in registered direct offering,

   net of offering costs

 

 

 

 

 

 

4,361,370

 

 

 

436

 

 

 

12,668,348

 

 

 

 

 

 

 

 

 

 

 

12,668,784

 

Issuance of common stock upon exercise of warrants

 

 

 

 

 

 

11,000

 

 

 

1

 

 

 

30,323

 

 

 

 

 

 

 

 

 

 

 

30,324

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,097,306

)

 

 

 

 

 

 

(2,097,306

)

Balance, March 31, 2019

 

 

 

 

 

 

13,450,680

 

 

$

1,313

 

 

$

183,314,257

 

 

$

(118,953,297

)

 

$

(5,040,163

)

 

$

59,322,110

 

Stock based compensation and vesting of restricted stock

 

 

 

 

 

 

71

 

 

 

 

 

 

 

289,800

 

 

 

 

 

 

 

 

 

 

 

289,800

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,386,888

)

 

 

 

 

 

 

(3,386,888

)

Balance, June 30, 2019

 

 

 

 

 

 

13,450,751

 

 

$

1,313

 

 

$

183,604,057

 

 

$

(122,340,185

)

 

$

(5,040,163

)

 

$

56,225,022

 

 


3


 

 

ALTIMMUNE, INC.

CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY

(unaudited)

 

 

 

Series B Redeemable

Convertible Preferred

Stock

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Accumulated

Other

Comprehensive

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance, January 1, 2018

 

 

12,177

 

 

$

9,281,767

 

 

 

608,499

 

 

$

61

 

 

$

121,657,587

 

 

$

(77,684,839

)

 

$

(4,576,986

)

 

$

39,395,823

 

Stock based compensation and vesting of restricted stock

 

 

 

 

 

 

 

 

 

 

71

 

 

 

 

 

 

356,737

 

 

 

 

 

 

 

 

 

 

 

356,737

 

Exercises of stock options

 

 

 

 

 

 

 

 

 

 

7,703

 

 

 

1

 

 

 

18,487

 

 

 

 

 

 

 

 

 

 

 

18,488

 

Conversion of Series B redeemable convertible preferred

   stock into common stock

 

 

(5,219

)

 

 

(5,218,572

)

 

 

130,447

 

 

 

13

 

 

 

5,218,559

 

 

 

 

 

 

 

 

 

 

 

5,218,572

 

Accretion of Series B Redeemable convertible preferred

   stock

 

 

 

 

 

 

1,891,321

 

 

 

 

 

 

 

 

 

 

 

(1,891,321

)

 

 

 

 

 

 

 

 

 

 

(1,891,321

)

Foreign currency translation adjustments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

615,471

 

 

 

615,471

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,173,538

)

 

 

 

 

 

 

(3,173,538

)

Balance, March 31, 2018

 

 

6,958

 

 

$

5,954,516

 

 

 

746,720

 

 

$

75

 

 

$

125,360,049

 

 

$

(80,858,377

)

 

$

(3,961,515

)

 

$

40,540,232

 

Stock based compensation and vesting of restricted stock

 

 

 

 

 

 

 

 

 

 

71

 

 

 

 

 

 

 

252,156

 

 

 

 

 

 

 

 

 

 

 

252,156

 

Exercises of stock options

 

 

 

 

 

 

 

 

 

 

1,837

 

 

 

-

 

 

 

4,410

 

 

 

 

 

 

 

 

 

 

 

4,410

 

Accretion of Series B redeemable convertible preferred stock

 

 

 

 

 

 

956,150

 

 

 

 

 

 

 

 

 

 

 

(956,150

)

 

 

 

 

 

 

 

 

 

 

(956,150

)

Conversion of Series B redeemable convertible preferred

  stock into common stock

 

 

(4,036

)

 

 

(4,036,539

)

 

 

334,180

 

 

 

33

 

 

 

4,036,506

 

 

 

 

 

 

 

 

 

 

 

4,036,539

 

Redemption of Series B redeemable convertible

  preferred stock for cash and release of embedded

  derivative

 

 

(2,364

)

 

 

(2,364,044

)

 

 

 

 

 

 

 

 

 

 

23,292

 

 

 

 

 

 

 

 

 

 

 

23,292

 

Issuance of common stock for the exchange of warrants

 

 

 

 

 

 

 

 

 

 

167,700

 

 

 

17

 

 

 

2,126,983

 

 

 

 

 

 

 

 

 

 

 

2,127,000

 

Foreign currency translation

   adjustments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,078,648

)

 

 

(1,078,648

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,138,842

)

 

 

 

 

 

 

(9,138,842

)

Balance, June 30, 2018

 

 

558

 

 

$

510,083

 

 

 

1,250,508

 

 

$

125

 

 

$

130,847,246

 

 

$

(89,997,219

)

 

$

(5,040,163

)

 

$

35,809,989

 

 

 

The accompanying notes are an integral part of the unaudited consolidated financial statements.

 

 

 

4


 

 

ALTIMMUNE, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

 

 

 

For the Six Months Ended

June 30,

 

 

 

2019

 

 

2018

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss

 

$

(5,484,194

)

 

$

(12,312,380

)

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

 

 

 

 

 

 

 

 

Impairment charge

 

 

 

 

 

490,676

 

Stock-based compensation

 

 

697,486

 

 

 

608,893

 

Depreciation

 

 

121,899

 

 

 

77,528

 

Amortization

 

 

107,580

 

 

 

29,446

 

Unrealized gains on foreign currency exchange

 

 

(24,943

)

 

 

 

Changes in fair value of warrant liability

 

 

46,000

 

 

 

3,680,709

 

Changes in fair value of embedded derivatives

 

 

 

 

 

2,130

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

832,098

 

 

 

951,727

 

Prepaid expenses and other current assets

 

 

(113,200

)

 

 

479,600

 

Accounts payable

 

 

(102,763

)

 

 

115,452

 

Accrued expenses and other current liabilities

 

 

(1,094,831

)

 

 

1,160,415

 

Deferred revenue

 

 

2,802

 

 

 

2,614

 

Lease obligation

 

 

(89,428

)

 

 

765,239

 

Tax refund receivable

 

 

(71,586

)

 

 

2,244,751

 

Deferred taxes

 

 

 

 

 

(1,507,358

)

Net cash used in operating activities

 

 

(5,173,080

)

 

 

(3,210,558

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(1,226

)

 

 

(811,646

)

Additions to intangible assets

 

 

(15,874

)

 

 

(27,505

)

Net cash used in investing activities

 

 

(17,100

)

 

 

(839,151

)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Redemption of preferred stock

 

 

 

 

 

(2,364,044

)

Cash paid in conjunction with warrant exchange

 

 

 

 

 

(1,100,000

)

Proceeds from issuance of common units, net of issuance costs

 

 

12,668,784

 

 

 

 

Proceeds from exercise of warrants

 

 

30,324

 

 

 

 

Payments of notes payable

 

 

(156,145

)

 

 

 

Proceeds from exercise of stock options

 

 

 

 

 

22,898

 

Net cash provided by (used in) financing activities

 

 

12,542,963

 

 

 

(3,441,146

)

EFFECT OF EXCHANGE RATES ON CASH

 

 

 

 

 

(50,365

)

Net increase (decrease) in cash and cash equivalents and restricted cash

 

 

7,352,783

 

 

 

(7,541,220

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

34,353,129

 

 

 

12,303,639

 

Cash, cash equivalents and restricted cash, end of period

 

$

41,705,912

 

 

$

4,762,419

 

SUPPLEMENTAL CASH FLOW INFORMATION:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

 

 

$

1,791

 

SUPPLEMENTAL NON-CASH FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Conversion of Series B redeemable convertible preferred stock into

   common stock

 

$

 

 

$

9,255,111

 

Accretion of Series B redeemable convertible preferred stock

 

$

 

 

$

2,847,471

 

Notes payable issued in conjunction with the exchange of warrants

 

$

 

 

$

1,500,000

 

Addition of property and equipment not yet paid

 

$

 

 

$

139,349

 

Addition of intangible assets not yet paid

 

$

 

 

$

5,763

 

Lease incentive billed but not yet received

 

$

 

 

$

139,349

 

 

The accompanying notes are an integral part of the unaudited consolidated financial statements.

5


 

 

ALTIMMUNE, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

1.Nature of Business and Basis of Presentation

Nature of Business

Altimmune, Inc., headquartered in Gaithersburg, Maryland, together with its subsidiaries (collectively, the “Company” or “Altimmune”) is a clinical stage biopharmaceutical company incorporated under the laws of the State of Delaware. The Company is focused on discovering and developing immunotherapies and vaccines to address significant unmet medical needs. Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and raising capital, and has financed its operations through the issuance of common and preferred stock, long-term debt, and proceeds from research grants and government contracts. The Company has not generated any revenues from the sale of any products to date, and there is no assurance of any future revenues from product sales.

The accompanying unaudited consolidated financial statements are prepared pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States for complete consolidated financial statements and should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2018 included in the annual report on Form 10-K which was filed with the SEC on April 1, 2019. In the opinion of management, the Company has prepared the accompanying unaudited consolidated financial statements on the same basis as the audited consolidated financial statements, and these consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the results of the interim periods presented. The operating results for the interim periods presented are not necessarily indicative of the results expected for the full year 2019 or any future years or periods.

Basis of presentation

The unaudited consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded assets and liabilities that might be necessary should we be unable to continue as a going concern.

On September 13, 2018, the Company filed Certificates of Amendment to its Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to increase the number of authorized shares of the Company’s common stock, par value $0.0001 per share, from 100,000,000 to 200,000,000 shares and to effect a reverse stock split of the Company’s common stock at a ratio of 1-for-30 (the “Reverse Stock Split”). All references set forth in this quarterly report to number of shares or per share data have been presented retroactively on a post Reverse Stock Split basis.

2.Summary of Significant Accounting Policies

During the six months ended June 30, 2019, there have been no significant changes to the Company’s summary of significant accounting policies contained in the Company’s Annual report on Form 10-K for the year ended December 31, 2018 as filed with the SEC, except for the recently adopted accounting standard for leases.

Leases

The Company determines if an arrangement is a lease at inception. Operating leases are recorded as a current and long-term lease obligation, with a corresponding right of use lease assets.

The lease obligations represent the Company’s obligation to make lease payments arising from the lease. The right of use lease assets represent the Company’s right to use an underlying asset for the lease term. The lease obligations and the operating right of use lease assets are recognized at the commencement date based on the present value of lease payments over the lease term. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term.

Short-term leases are leases having a term of twelve months or less. The Company recognizes short-term leases on a straight-line basis and does not record a related lease asset or liability for such leases.

6


 

 

Recently Issued Accounting Pronouncements - Adopted

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 requires a lessee to separate the lease components from the non-lease components in a contract and recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018. The standard requires a modified retrospective approach or an optional transition to apply the new guidance in the year of transition rather than at the beginning of the earliest period presented. The Company adopted ASU 2016-02 in the first quarter of 2019 under the optional transition method. The Company’s current operating leases will be accounted for as operating lease liabilities and right of use assets upon adoption. The Company has elected the package of practical expedients permitted. Accordingly, the Company accounted for its existing operating leases as operating leases under the new guidance, without reassessing (a) whether the contracts contain a lease, (b) whether classification of the operating leases would be different in accordance, or (c) whether the unamortized initial direct costs before transition adjustments would have met the definition of initial direct costs at lease commencement. In addition, the Company does not allocate the consideration between lease and non-lease components. On January 1, 2019, the Company recorded a lease liability and a corresponding right of use asset. The adjustment resulted in an increase of $756,347 to total assets and total liabilities on the January 1, 2019 consolidated balance sheet. The adoption will not have a material impact on the consolidated statement of operations or consolidated statement of cash flows.

In June 2018, FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718)—Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The Company adopted ASU 2018-07 in the first quarter of 2019. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.

Recently Issued Accounting Pronouncements - Pending Adoption

In August 2018, FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) – Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement, was issued to modify and enhance the disclosure requirements for fair value measurements. This update is effective in fiscal years, including interim periods, beginning after December 15, 2019, and early adoption is permitted. The Company is still completing its assessment of the impacts and anticipated adoption date of this guidance.

3.Acquisitions

Subsequent to the quarter ended June 30, 2019, the Company entered into a definitive agreement to acquire all of the equity interests of Spitfire Pharma, Inc. (“Spitfire”) on July 8, 2019. Spitfire was a privately held, preclinical pharmaceutical company developing a novel dual GLP-1/glucagon receptor agonist for the treatment of non-alcoholic steatohepatitis.  

The transaction closed on July 12, 2019. The Company issued 1,887,250 unregistered shares of its common stock (the “Shares”) as upfront consideration to certain former securityholders of Spitfire (collectively, the “Spitfire Equityholders”), representing an amount equal to $5,000,000 less working capital and transaction expense adjustment amounts as defined in the agreement (the “Closing Consideration”). The number of Shares issued as payment of the Closing Consideration was determined based on the average of the closing prices of the Company’s common stock as reported on the Nasdaq Global Market for the twenty (20) consecutive trading days prior to and including July 8, 2019, the date on which the parties entered into the Agreement and Plan of Merger and Reorganization (the “Merger Agreement”).

The Merger Agreement includes $88,000,000 in future contingent payments for regulatory, clinical and sales milestones using the acquired intellectual property. The Company will record the contingent consideration when and if the milestones are achieved and the milestone payments become payable.

The Company determined that the acquisition of Spitfire should be accounted for as an asset acquisition instead of a business combination because substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets, and therefore, the asset is not considered a business. The Company plans to expense the acquired intellectual property as of the acquisition date as in-process research and development with no alternative future uses. The Company expects to record an in-process research and development expense for the up-front consideration during the third quarter of 2019. Transaction costs of $618,417 are recorded within research and development expense on the Consolidated Statements of Operations and Comprehensive Loss during the three and six months ended June 30, 2019

4.Net Loss Per Share

Because the Company has reported a net loss attributable to common stockholders for all periods presented, basic and diluted net loss per share attributable to common stockholders are the same for all periods presented. For periods presented, all preferred stock, unvested restricted stock, common stock warrants, and stock options have been excluded from the computation of diluted weighted-average shares outstanding because such securities would have an antidilutive impact.

 

7


 

 

Potential common shares issuable upon conversion, vesting or exercise of preferred stock, unvested restricted stock, common stock warrants, and stock options that are excluded from the computation of diluted weighted-average shares outstanding are as follows:

 

 

 

As of June 30,

 

 

 

2019

 

 

2018

 

Redeemable preferred stock

 

 

-

 

 

 

6,966

 

Common stock warrants

 

 

10,386,256

 

 

 

25,211

 

Common stock options

 

 

873,066

 

 

 

53,846

 

Restricted stock

 

 

323,262

 

 

 

639

 

 

5.Goodwill and Intangible Assets

Goodwill

In May 2017, the Company closed on a business combination and recorded an initial purchase price allocation including goodwill. During the six months ended June 30, 2018 and prior to the end of the measurement period for accounting for the business combination, the Company recorded adjustments to the purchase price allocation resulting in a net decrease in tax refunds receivable, with a corresponding net increase in goodwill, of $490,676. As goodwill related to this transaction had previously been determined to be fully impaired, the Company recognized an impairment charge of $490,676 as a result of these purchase price allocation adjustments during the six months ended June 30, 2018. The purchase price allocation was considered final in May 2018, and no further adjustments were recorded.

 

Intangibles assets

The Company’s intangible assets consisted of the following:

 

 

 

June 30, 2019

 

 

 

Estimated

Useful

Lives

 

Gross

Carrying

Value

 

 

Accumulated

Amortization

 

 

Net Book

Value

 

Internally developed patents

 

6-10 years

 

$

734,432

 

 

$

(416,857

)

 

$

317,575

 

Acquired licenses

 

16-20 years

 

 

285,000

 

 

 

(261,326

)

 

 

23,674

 

Total intangible assets subject to amortization

 

 

 

 

1,019,432

 

 

 

(678,183

)

 

 

341,249

 

IPR&D assets

 

Indefinite

 

 

13,418,967

 

 

 

 

 

 

13,418,967

 

Total

 

 

 

$

14,438,399

 

 

$

(678,183

)

 

$

13,760,216

 

 

 

 

December 31, 2018

 

 

 

Estimated

Useful

Lives

 

Gross

Carrying

Value

 

 

Accumulated

Amortization

 

 

Impairment

 

 

Net Book

Value

 

Internally developed patents

 

6-10 years

 

$

718,559

 

 

$

(317,172

)

 

$

 

 

$

401,387

 

Acquired licenses

 

16-20 years

 

 

285,000

 

 

 

(253,430

)

 

 

 

 

 

31,570

 

Total intangible assets subject to amortization

 

 

 

$

1,003,559

 

 

$

(570,602

)

 

$

 

 

$

432,957

 

IPR&D assets

 

Indefinite

 

 

37,868,978

 

 

 

 

 

 

(24,450,011

)

 

 

13,418,967

 

Total

 

 

 

$

38,872,537

 

 

$

(570,602

)

 

$

(24,450,011

)

 

$

13,851,924

 

Amortization expense of intangible assets subject to amortization was $14,836 and $14,972 for the three months ended June 30, 2019 and 2018, and $107,580 and $29,446 for the six months ended June 30, 2019 and 2018, respectively. Amortization expense was classified as research and development expenses in the accompanying unaudited consolidated statements of operations and comprehensive loss.

As of June 30, 2019, future estimated amortization expense was as follows:

 

Years ending December 31,

 

 

 

 

The remainder of 2019

 

$

29,690

 

2020

 

 

45,933

 

2021

 

 

25,375

 

2022

 

 

25,375

 

2023

 

 

25,375

 

2024 and thereafter

 

 

189,501

 

Total

 

$

341,249

 

 

8


 

 

6.Accrued Expenses

Accrued expenses and other current liabilities consist of the following:

 

 

 

June 30,

2019

 

 

December 31,

2018

 

Accrued professional services

 

$

417,618

 

 

$

552,619

 

Accrued payroll and employee benefits

 

 

808,585

 

 

 

1,257,191

 

Accrued interest

 

 

2,685

 

 

 

1,192

 

Accrued research and development

 

 

1,539,045

 

 

 

2,076,704

 

Lease obligation, current portion

 

 

246,193

 

 

 

 

Deferred rent, current portion

 

 

 

 

 

175,490

 

Deferred revenue

 

 

32,441

 

 

 

19,753

 

Total accrued expenses

 

$

3,046,567

 

 

$

4,082,949

 

 

7.Notes Payable and Other Long-Term Liabilities

The Company’s current portion of outstanding notes payable are summarized as follows:

 

 

June 30,

2019

 

 

December 31,

2018

 

BPI France notes, short-term portion

 

$

163,724

 

 

$

71,596

 

Total notes payable

 

$

163,724

 

 

$

71,596

 

 

The Company’s long-term portion of outstanding notes payable as well as other long-term liabilities are summarized as follows:

 

 

 

June 30,

2019

 

 

December 31,

2018

 

BPI France notes, long-term portion

 

$

252,902

 

 

$

501,174

 

Lease obligation, long-term portion (see Note 11)

 

 

1,618,055

 

 

 

 

Deferred rent, long-term portion

 

 

 

 

 

1,045,807

 

Common stock warrant liability (see Note 9)

 

 

111,000

 

 

 

65,000

 

Other

 

 

230,147

 

 

 

240,090

 

Total other long-term liabilities

 

$

2,212,104

 

 

$

1,852,071

 

 

Line of Credit

On July 27, 2018, the Company renewed its existing line of credit agreement for a six-month term with an increase to the borrowing capacity from $250,000 to $1,750,000, subject to a minimum liquidity requirement equal to the outstanding balance of the line. The line of credit was not renewed and expired in January 2019. There was no balance on this credit facility as of December 31, 2018 or for the period within 2019 prior to its expiration.

BPI France Notes

Altimmune France has two non-interest-bearing research and development funding arrangements with BPI France that were entered into in December 2013 to provide Altimmune France up to €750,000 in research funding in the first arrangement and up to €250,000 in the second arrangement. Altimmune France was permitted to draw 50% of the funds upon the signing of the arrangements, an additional 30% contingent upon a financial audit and technical progress report, and the remaining amounts at the completion of the research and development project being funded by the arrangements. In October 2016, the Company and BPI France agreed to extend the term on the arrangement by two years. Each of the two obligations is repayable in sixteen quarterly installments from June 2019 through March 2023. The total amount advanced under the arrangements was €500,000 as of June 30, 2019 ($568,321 as of June 30, 2019). In April 2019, the Company was notified that €102,951 ($117,018 as of June 30, 2019) exceeded the allowable funding in accordance with the arrangement and made payment of this amount on June 5, 2019. The remaining balance is repayable in sixteen quarterly installments from June 2019 through March 2023, and the Company paid €31,250 ($35,520) during the six months ended June 30, 2019. As of June 30, 2019, $163,724 on this note is classified as short term, and $252,902 as long term. The BPI France notes are recorded at their repayment value which approximates fair value.

8.Common Stock

On March 12, 2019, the Company issued a combined total of 1,500,000 common units and 2,861,370 pre-funded units to two institutional investors in a registered direct offering (the “Registered Direct Offering”). Each common unit in the Registered Direct Offering was sold at a price of $3.21 and consisted of one share of common stock and 0.70 of a warrant to purchase one share of common stock at an exercise price of $3.21. Each warrant sold in the Registered Direct Offering was exercisable immediately and expired five years from the date of issuance. Each pre-funded unit in the Registered Direct Offering was sold at a public offering price of $3.20 and consisted of a pre-funded warrant to purchase

9


 

 

one share of common stock at an exercise price of $0.01 per share and 0.70 of a warrant to purchase one share of common stock at an exercise price of $3.21. The pre-funded warrants were immediately exercisable and were able to be exercised at any time until all of the pre-funded warrants were exercised in full. All of the pre-funded warrants were exercised prior to March 31, 2019. The net proceeds of the Registered Direct Offering were approximately $12,668,784, after deducting the underwriting discount and offering expenses payable by the Company.

The warrants issued in the Registered Direct Offering were concluded to be equity classified freestanding financial instruments. The Registered Direct Offering triggered a down round adjustment to the exercise price of warrants previously issued in an October 2018 public offering from $4.1798 to $2.7568. The Company treated the value of the effect of the reduction in exercise price as a deemed dividend of $452,925 during the six months ended June 30, 2019, which reduced income available to common shareholders.

9.Warrants

A summary of warrant activity during the six months ended June 30, 2019 is as follows:

 

 

 

 

 

 

 

 

 

Warrants outstanding, beginning of period

 

 

7,344,297

 

 

Issuances

 

 

3,052,959

 

 

Exercises and conversions

 

 

(11,000

)

 

Warrants outstanding, end of period

 

 

10,386,256

 

 

 

For warrants classified as a liability, the following is a summary of the periodic changes in their fair value during the six months ended June 30, 2019:

 

Balance, January 1, 2019

 

$

65,000

 

Changes in fair value (Monte Carlo simulation valuation)

 

 

46,000

 

Balance, June 30, 2019

 

$

111,000

 

 

The fair value of common warrants classified as a liability was estimated using the Monte Carlo simulation valuation model with Level 3 inputs. The following assumptions were used to estimate the fair value of warrants that were classified as a liability at June 30, 2019.

 

 

 

 

 

Expected volatility

 

96.3

%

Expected term (years)

 

3.10

 

Risk-free interest rate

 

1.7

%

Expected dividend yield

 

0.0

%

 

10.Stock-Based Compensation

Stock Options

The Company’s stock option awards generally vest over four years and typically have a contractual life of ten years. At June 30, 2019, there was $1,579,524 of unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted-average period of 3.39 years. During the six months ended June 30, 2019, the Company granted 618,000 stock options with a weighted average price of $2.76 and per share weighted average grant date fair value of $2.09.

Information related to stock options outstanding at June 30, 2019 is as follows:

 

 

Number

of Stock

Options

 

 

Weighted-

average

Exercise

Price

 

 

Weighted-

average

Remaining

Contractual

Term

(Years)

 

 

Aggregate

Intrinsic

Value

 

Outstanding

 

 

873,066

 

 

$

5.67

 

 

 

5.89

 

 

$

2,000

 

Exercisable

 

 

112,944

 

 

$

18.97

 

 

 

5.18

 

 

$

-

 

Unvested

 

 

760,122

 

 

$

3.69

 

 

 

5.99

 

 

$

2,000

 

 

Restricted Stock

At June 30, 2019, the Company had unvested restricted stock of 323,262 shares with total unrecognized compensation expense of $990,288, which the Company expects to recognize over a weighted average period of approximately 3.42 years. During the six months ended June 30, 2019, the Company released 71 shares of common stock from restriction as a result of the vesting of restricted stock.

10


 

 

Stock-based compensation expense

Stock-based compensation expense is classified in the unaudited consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2019 and 2018 as follows:

 

 

For the Three Months Ended

June 30,

 

 

For the Six Months Ended

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Research and development

 

$

92,060

 

 

$

108,276

 

 

$

168,684

 

 

$

197,312

 

General and administrative

 

 

197,712

 

 

 

143,850

 

 

 

528,802

 

 

 

411,581

 

Total

 

$

289,772

 

 

$

252,126

 

 

$

697,486

 

 

$

608,893

 

2019 Employee Stock Purchase Plan

On March 29, 2019, the board of directors adopted the 2019 Employee Stock Purchase Plan (the “2019 ESPP”). A total of 403,500 shares of the Company’s common stock have been reserved for issuance under the 2019 ESPP. Subject to any plan limitations, the 2019 ESPP allows eligible employees to contribute through payroll deductions up to 10% of their earnings for the purchase of the Company’s common stock at a discounted price per share. The offering periods begin in February and August of each year, with the initial offering period commencing on August 1, 2019. The common shares issuable under the 2019 ESPP were registered pursuant to a registration statement on Form S-8 on April 4, 2019.

 

Unless otherwise determined by the administrator, the Company’s common stock will be purchased for the accounts of employees participating in the 2019 ESPP at a price per share that is the lesser of 85% of the fair market value of the Company’s common stock on the first trading day of the offering period or 85% of the fair market value of the Company’s common stock on the last trading day of the offering period.

 

11.Operating Leases

The Company rents office and laboratory space in the United States. The Company also leases office equipment under a non-cancellable equipment lease through December 2022. Rent expense during the three and six months ended June 30, 2019 under all of the Company’s operating leases was $83,903 and $174,079, respectively, which includes short-term leases and variable lease costs not included in the lease obligation.

Short-term leases are leases having a term of twelve months or less. The Company recognizes short-term leases on a straight-line basis and does not record a related lease asset or liability for such leases.

The office space lease provides for increases in future minimum annual rental payments as defined in the lease agreements. The Company has determined the lease renewal option is not reasonably certain.

The operating cash outflows related to operating leases for the six months ended June 30, 2019 was $89,428.

Supplemental other information related to the operating leases balance sheet information is as follows:

 

 

June 30, 2019

 

Operating lease obligations

 

$

1,864,248

 

Operating lease right-of-use assets

 

$

732,380

 

Weighted-average remaining lease term

 

 

5.83

 

Weighted-average discount rate

 

 

8.0

%

Maturities of lease liabilities is as follows:

Year ending December 31,

 

 

 

 

The remainder of 2019

 

$

191,428

 

2020

 

 

387,079

 

2021

 

 

393,542

 

2022

 

 

400,198

 

2023

 

 

407,054

 

2024 and thereafter

 

 

552,948

 

Total lease payments

 

 

2,332,249

 

Less imputed interest

 

 

(468,001

)

Total

 

$

1,864,248

 

 

 

12.Commitments and Contingencies

The Company is a party in various other contractual disputes, litigation, and potential claims arising in the ordinary course of business. The Company does not believe that the resolution of these matters will have a material adverse effect on its financial position or results of operations.

11


 

 

13.Subsequent Events

Refer to Note 3 for a description of the Merger Agreement entered into on July 8, 2019.

12


 

 

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 together with our consolidated financial statements and related notes appearing elsewhere in this quarterly report on Form 10-Q and our consolidated financial statements and related notes for the year ended December 31, 2018 included in our annual report on Form 10-K, which was filed with the Securities and Exchange Commission on April 1, 2019.

This quarterly report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. The words “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “may,” “will,” “should,” “could,” “target,” “strategy,” “intend,” “project,” “guidance,” “likely,” “usually,” “potential,” or the negative of these words or variations of such words, similar expressions, or comparable terminology are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. There are a number of important risks and uncertainties that could cause our actual results to differ materially from those indicated by forward-looking statements. 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 included in this quarterly report on Form 10-Q, particularly in the section entitled “Risk Factors” in Part II, Item 1A, 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, joint ventures or investments that we may make.

We have based the forward-looking statements included in this quarterly report on Form 10-Q on information available to us on the date of this quarterly report, and we assume no obligation to update any such forward-looking statements, other than as required by law. Although we undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise, you are advised to consult any additional disclosures that we may make directly to you or through reports that we, in the future, may file with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K.

Overview

Altimmune, Inc. is a clinical stage biopharmaceutical company focused on developing liver disease and immune modulating therapies. Our diverse pipeline includes next generation peptide therapeutics for NASH (ALT-801) and chronic Hepatitis B (HepTcellTM), conjugated immunostimulants for the treatment of cancer (ALT-702) and intranasal vaccines (NasoVAXTM and NasoShieldTM).

Reverse Stock Split

On September 13, 2018 we amended our Amended and Restated Certificate of Incorporation to effect a reverse stock split of our issued and outstanding common stock at a ratio 1-for-30, or the “Reverse Stock Split”. The Reverse Stock Split was effective on September 13, 2018, and our shares of common stock commenced trading on the NASDAQ Global Market on a post-Reverse Stock Split basis on September 14, 2018. Unless otherwise noted, all share and per share numbers in this Quarterly Report on Form 10-Q are reflected on a Post-Reverse Stock Split basis for all periods presented.

Acquisition

Subsequent to the quarter ended June 30, 2019, the Company entered into a definitive agreement to acquire all of the equity interests of Spitfire Pharma, Inc. (“Spitfire”) on July 8, 2019. Spitfire was a privately held, preclinical pharmaceutical company developing a novel dual GLP-1/glucagon receptor agonist for the treatment of non-alcoholic steatohepatitis.  

The transaction closed on July 12, 2019. The Company issued 1,887,250 unregistered shares of its common stock (the “Shares”) as upfront consideration to certain former securityholders of Spitfire (collectively, the “Spitfire Equityholders”), representing an amount equal to $5.0 million less working capital and transaction expense adjustment amounts (the “Closing Consideration”). The number of Shares issued as payment of the Closing Consideration was determined based on the average of the closing prices of the Company’s common stock as reported on the Nasdaq Global Market for the twenty (20) consecutive trading days prior to and including July 8, 2019, the date on which the parties entered into the Agreement and Plan of Merger and Reorganization (the “Merger Agreement”).

 

The Merger Agreement also includes $88.0 million in future contingent payments based on regulatory, clinical and sales milestones using the acquired intellectual property. The Company will record the contingent consideration when and if the milestones are achieved and the milestone payments become payable.

Critical Accounting Policies and Significant Judgment and Estimates

Management’s Discussion and Analysis of Financial Condition and Results of Operations is based upon our unaudited consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. and the rules and regulations of the SEC for interim financial reporting. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses, and the related disclosure of contingent assets and liabilities. We base our estimates and judgments on historical experience, knowledge of current conditions, and expectations of what could occur in the future given available information.

13


 

 

There have been no changes in our critical accounting policies and significant judgment and estimates as disclosed in our annual report on Form 10-K for the year ended December 31, 2018 except for recently adopted accounting standards (See note 2). For more information regarding our critical accounting policies, we encourage you to read the discussion contained in Item 7 under the heading “Critical Accounting Policies and Significant Judgments and Estimates” and Note 2 “Summary of Significant Accounting Policies” included in the notes to the consolidated financial statements contained in our annual report on Form 10-K for the year ended December 31, 2018.

Results of Operations

Comparison of the three months ended June 30, 2019 and 2018:

 

 

 

For the Three Months Ended

June 30,

 

 

2019

 

 

2018

 

 

Increase (Decrease)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

1,626,029

 

 

$

2,417,140

 

 

$

(791,111

)

 

 

(32.7

)

%

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

2,945,096

 

 

 

4,918,961

 

 

 

(1,973,865

)

 

 

(40.1

)

 

General and administrative

 

 

2,231,817

 

 

 

2,933,982

 

 

 

(702,165

)

 

 

(23.9

)

 

Total operating expenses

 

 

5,176,913

 

 

 

7,852,943

 

 

 

(2,676,030

)

 

 

(34.1

)

 

Loss from operations

 

 

(3,550,884

)

 

 

(5,435,803

)

 

 

1,884,919

 

 

 

(34.7

)

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Changes in fair value of warrant

   liability

 

 

(46,000

)

 

 

(5,228,691

)

 

 

5,182,691

 

 

 

(99.1

)

 

Changes in fair value of embedded

   derivative

 

 

 

 

 

4,912

 

 

 

(4,912

)

 

 

 

 

Interest expense

 

 

(748

)

 

 

(1,921

)

 

 

1,173

 

 

 

(61.1

)

 

Interest income

 

 

239,964

 

 

 

25,617

 

 

 

214,347

 

 

 

836.7

 

 

Other income (expenses)

 

 

(29,220

)

 

 

(49

)

 

 

(29,171

)

 

 

59,532.7

 

 

Total other income (expense)

 

 

163,996

 

 

 

(5,200,132

)

 

 

5,364,128

 

 

 

(103.2

)

 

Net loss before income tax benefit

 

 

(3,386,888

)

 

 

(10,635,935

)

 

 

7,249,047

 

 

 

(68.2

)

 

Income tax benefit

 

 

 

 

 

1,497,093

 

 

 

(1,497,093

)

 

 

 

 

Net loss

 

$

(3,386,888

)

 

$

(9,138,842

)

 

$

5,751,954

 

 

 

(62.9

)

%

Comparison of the six months ended June 30, 2019 and 2018:

 

 

For the Six Months Ended

June 30,

 

 

2019

 

 

2018

 

 

Increase (Decrease)

Revenue

 

$

4,581,622

 

 

$

5,108,121

 

 

$

(526,499

)

 

 

(10.3

)

%

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

6,162,768

 

 

 

10,665,890

 

 

 

(4,503,122

)

 

 

(42.2

)

 

General and administrative

 

 

4,298,299

 

 

 

5,381,917

 

 

 

(1,083,618

)

 

 

(20.1

)

 

Goodwill impairment

 

 

 

 

 

490,676

 

 

 

(490,676

)

 

 

 

 

Total operating expenses

 

 

10,461,067

 

 

 

16,538,483

 

 

 

(6,077,416

)

 

 

(36.7

)

 

Loss from operations

 

 

(5,879,445

)

 

 

(11,430,362

)

 

 

5,550,917

 

 

 

(48.6

)

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Changes in fair value of warrant

   liability

 

 

(46,000

)

 

 

(3,680,709

)

 

 

3,634,709

 

 

 

(98.8

)

 

Changes in fair value of embedded

   derivative

 

 

 

 

 

(2,130

)

 

 

2,130

 

 

 

 

 

Interest expense

 

 

(1,488

)

 

 

(2,791

)

 

 

1,303

 

 

 

(46.7

)

 

Interest income

 

 

425,211

 

 

 

57,206

 

 

 

368,005

 

 

 

643.3

 

 

Other income (expenses)

 

 

17,528

 

 

 

257,675

 

 

 

(240,147

)

 

 

(93.2

)

 

Total other income (expense)

 

 

395,251

 

 

 

(3,370,749

)

 

 

3,766,000

 

 

 

(111.7

)

 

Net loss before income tax benefit

 

 

(5,484,194

)

 

 

(14,801,111

)

 

 

9,316,917

 

 

 

(62.9

)

 

Income tax benefit

 

 

-

 

 

 

2,488,731

 

 

 

(2,488,731

)

 

 

 

 

Net loss

 

$

(5,484,194

)

 

$

(12,312,380

)

 

$

6,828,186

 

 

 

(55.5

)

%

Revenue

Revenue consists primarily of research grants from Biomedical Advanced Research and Development Authority, or BARDA, and the National Institute of Allergy and Infectious Diseases, or NIAID, in the United States for our anthrax vaccine product candidates. These grants consist of cost reimbursement contracts, with a fixed fee based on either costs or milestones.

14


 

 

Revenue decreased by $0.79 million, or 32.7%, for the three months ended June 30, 2019 as compared to the same period in 2018. The increase was primarily the result of:

 

a decrease of $0.34 million in BARDA revenue due directly to changes in spending on the NasoShield program; and

 

a decrease of $0.45 million in NIAID revenue due to the activities diminishing under the SparVax-L program as it approaches conclusion.

Revenue decreased by $0.53 million, or 10.3%, for the six months ended June 30, 2019, as compared to the same period in 2018. The increase was primarily the result of:

 

an increase of $0.53 million in BARDA revenue due directly to changes in spending on the NasoShield program; and

 

a decrease of $1.06 million in NIAID revenue due to the activities diminishing under the SparVax-L program as it approaches conclusion.

Research and development expenses

Research and development operating expense decreased by $1.97 million, or 40.1%, for the three months ended June 30, 2019 as compared to the same period in 2018. The decrease was primarily the result of:

 

a decrease of $1.45 million due to timing of clinical trial and manufacturing development activities for NasoVAX;

 

a decrease of $0.58 million due to timing of a clinical trial and related activities for HepTcell;

 

a decrease of $0.26 million due to reduced development cost for SparVax-L as it approaches conclusion;

 

a decrease of $0.24 million due to timing of clinical trial and manufacturing development activities for NasoShield;

 

a decrease of $0.06 million in non-project specific research and development costs including employee compensation and facility costs; and

 

an increase of $0.62 million due to transaction costs incurred with respect to the Spitfire acquisition.

Research and development operating expense decreased by $4.50 million, or 42.2%, for the six months ended June 30, 2019, as compared to the same period in 2018. The decrease was primarily the result of:

 

a decrease of $3.12 million due to timing of clinical trial and manufacturing development activities for NasoVAX;

 

a decrease of $1.56 million due to timing of a clinical trial and related activities for HepTcell;

 

a decrease of $0.60 million due to reduced development cost for SparVax-L as it approaches conclusion;

 

a decrease of $0.25 million in non-project specific research and development costs including employee compensation and facility costs;

 

an increase of $0.41 due to timing of clinical trial and manufacturing development activities for NasoShield; and

 

an increase of $0.62 million due to due to transaction costs incurred with respect to the Spitfire acquisition.

General and administrative expenses

General and administrative expense decreased by $0.7 million, or 23.9%, for the three months ended June 30, 2019 and by $1.1 million, or 20.1% for the six months ended June 30, 2019, as compared to the same periods in 2018 primarily due to a reduction in labor, legal and professional costs.

Goodwill impairment

Goodwill impairment charges reported during the six months ended June 30, 2018 represented an adjustment recorded during the measurement period to reduce the tax refund receivable acquired in connection with a 2017 business combination. We recorded adjustments to the purchase price allocation resulting in a net decrease in tax refunds receivable, with a corresponding net increase in goodwill, of $490,676. As goodwill related to this transaction had previously been determined to be fully impaired, we recognized an impairment charge of $490,676. The purchase price allocation was considered final in May 2018, and no further adjustments were recorded.

Other income (expense)

Other income (expense) decreased by $5.4 million and $3.8 million during the three and six months ended June 30, 2019, respectively, as compared to the same periods in 2018. The decreases are primarily due to changes in the fair value of warrant liability and embedded derivatives.

Income tax benefit

We recorded no income tax benefit or expense for the three and six months ended June 30, 2019, as compared to an income tax benefit of $1.5 million and $2.5 million for the same respective periods in 2018. We had a valuation allowance against most of the deferred tax assets. During the three and six months ended June 30, 2019, we did not identify any discrete items, therefore all of our tax loss was applied to the valuation allowance. During the six months ended June 30, 2018, our income tax benefit included $1.5 million for our projected 2018 unlimited

15


 

 

lived Federal net operating loss determined to be realizable, $0.7 million due to Maryland state net operating losses, and discrete tax benefits of $0.3 million related to a change in estimate.

Liquidity and Capital Resources

Overview

Our primary sources of cash during the six months ended June 30, 2019 was the cash on-hand as of January 1, 2019 and the receipt of $12.7 million in proceeds from the Registered Direct Offering. Our cash and cash equivalents were $41.7 million at June 30, 2019. We believe, based on the operating cash requirements and capital expenditures expected for 2019, our cash on hand at June 30, 2019, and revenue from our government sponsored contracts, are sufficient to fund operations for at least a twelve-month period from the issuance date of our June 30, 2019 financial statements.

We have not generated any revenues from the sale of any products to date, and there is no assurance of any future revenues from product sales. Our sources of revenue consist of revenues under our contract with BARDA and NIAID for the development of NasoShield and SparVax-L, respectively, and to a lesser degree from other licensing arrangements. We have incurred significant losses since we commenced operations. As of June 30, 2019, we had accumulated losses of $122.3 million since our inception. In addition, we have not generated positive cash flows from operations. We have had to rely on a variety of financing sources, including the issuance of debt and equity securities. As capital resources are consumed to fund our research and development activities, we may not have sufficient capital to fund our plan of operations. In order to address our capital needs, including our planned clinical trials, we must continue to actively pursue additional equity or debt financing, government funding, and monetization of our existing programs through partnership arrangements or sales to third parties.

In July 2016, we signed a five-year contract with BARDA. The contract, as amended, has a total value of up to $130.0 million and is used to fund clinical development of NasoShield. Under the contract, BARDA pays us a fixed fee and reimburses certain costs for the research and development of an Ad5-vectored, protective antigen-based intranasal anthrax vaccine through cGMP manufacture and conduct of a Phase 1 clinical trial dose ranging assessment of safety and immunogenicity. The contract consists of an initial base performance period providing approximately $24.1 million in funding for the period July 2016 through November 2019. BARDA has seven options to extend the contract to fund certain continued development and manufacturing activities for the anthrax vaccine, including Phase 2 clinical trials. Each option, if exercised by BARDA, would provide additional funding ranging from approximately $1.1 million to $34.4 million for the period November 2019 through July 2021. Through June 30, 2019, we have received an aggregate of approximately $19.6 million under the current BARDA contract.

We have a NIAID contract that is incrementally funded for the development of SparVax-L. Over the base period of the contract, approximately $5.2 million was awarded for initial funding, which includes a cost reimbursement component and a fixed fee component payable upon achievement of certain milestones. NIAID exercised options under this agreement to provide additional funding of approximately $10.1 million and an extension of the period of performance through September 2019. The contract had a maximum total value of up to approximately $28.1 million if all technical milestones were met and all eight contract options were exercised by NIAID. Work under all exercised options will bring total committed and final funding under the NIAID contract to $15.3 million. Activities under this contract are substantially complete, and we are seeking additional government funding to advance the program beyond the completion of this contract. No such funding has been identified as of the date of this filing.

Cash Flows

The following table provides information regarding our cash flows for the three months ended June 30, 2019 and 2018:

 

 

 

For the Six Months Ended

June 30,

 

 

 

2019

 

 

2018

 

Net cash provided by (used in):

 

 

 

 

 

 

 

 

Operating activities

 

$

(5,173,080

)

 

$

(3,210,558

)

Investing activities

 

$

(17,100

)

 

$

(839,151

)

Financing activities

 

$

12,542,963

 

 

$

(3,441,146

)

 

Operating Activities

Net cash used in operating activities was $5.2 million for the six months ended June 30, 2019 compared to $3.2 million during the six months ended June 30, 2018. Our sources of cash provided by operations during the three months ended June 30, 2019 were primarily cash receipts of revenue generated by our BARDA and NIAID contracts. The primary uses of cash from our operating activities include payments for labor and labor-related costs, professional fees, research and development costs associated with our clinical trials, and other general corporate expenditures. The increase in cash used in operations of $2.0 million year over year is due to a decrease in net loss as adjusted for noncash items of $3.5 million offset by changes in working capital accounts of $5.5 million.

Investing Activities

Net cash used in investing activities was $0.02 million for the six months ended June 30, 2019 compared to $0.84 million during the six months ended June 30, 2018. The net cash used in investing activities during 2018 was primarily due to purchases of property and equipment related to the buildout of the Company’s new office and laboratory facilities which was completed in 2018.

16


 

 

Financing Activities

Net cash provided by financing activities during the six months ended June 30, 2019 was $12.5 million compared to net cash used in financing activities of $3.4 million for the same period in 2018. The net cash provided by financing activities during the six months ended June 30, 2019 was primarily the result of the receipt of $12.7 million in proceeds from the Registered Direct Offering (as discussed below). The net cash used by financing activities during the six months ended June 30, 2018 was the result of cash paid to redeem preferred stock and retire certain warrants.

Financing

On March 12, 2019, we issued a combined total of 1,500,000 common units and 2,861,370 pre-funded units to certain institutional investors in a registered direct offering or the “Registered Direct Offering”. Each common unit in the Registered Direct Offering was sold at a price of $3.21 and consisted of one share of our common stock and 0.70 of a warrant to purchase one share of our common stock at an exercise price of $3.21. Each warrant sold in the Registered Direct Offering was exercisable immediately and expires five years from the date of issuance. Each pre-funded unit in the Registered Direct Offering was sold at a public offering price of $3.20 and consisted of a pre-funded warrant to purchase one share of our common stock at an exercise price of $0.01 per share and 0.70 of a warrant to purchase one share of our common stock at an exercise price of $3.21. The pre-funded warrants were immediately exercisable and were able to be exercised at any time until all of the pre-funded warrants are exercised in full. All of the pre-funded warrants were exercised prior to March 31, 2019. The net proceeds of the Registered Direct Offering were approximately $12.7 million, after deducting the underwriting discount and offering expenses payable by us. The Registered Direct Offering triggered an adjustment to the exercise price of the warrants issued with the offering of common units and pre-funded units on October 2, 2018 from $4.1798 to $2.7568.

Current Resources

We have financed our operations to date principally through proceeds from issuances of our preferred stock, common stock, and warrants. At June 30, 2019, we had $41.7 million of cash, cash equivalents and restricted cash. Accordingly, management believes that the Company has sufficient capital to fund its plan of operations for at least a twelve-month period from the issuance date of our June 30, 2019 financial statements. However, in order to address our capital needs in the long-term, including our planned clinical trials, we must continue to actively pursue additional equity or debt financing, government funding, and monetization of our existing programs through partnership arrangements or sales to third parties.

Off-Balance Sheet Arrangements

As of June 30, 2019, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as “special purpose” entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

Item 3.

Quantitative and Qualitative Disclosures about Market Risk.

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide the information required by this Item.

Item 4.

Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures pursuant to Rule 13a-15 under the Securities Exchange Act of 1934, as amended (“the “Exchange Act”) as of the end of the period covered by this Quarterly Report on Form 10-Q.

Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of June 30, 2019, our disclosure controls and procedures were effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and Rule 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2019 identified in connection with the evaluation thereof by our management, including the Chief Executive Officer and Chief Financial Officer, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

17


 

 

PART II — OTHER INFORMATION

Item 1.

Legal Proceedings

None.

Item 1A.

Risk Factors

In addition to the other information set forth in this Form 10-Q, you should carefully consider the factors discussed in Part I, Item 1A, subsection “Risk Factors” in our 2018 Annual Report on Form 10-K filed with the SEC on April 1, 2019, as they could materially affect our business, financial condition or future results of operations. The risks described in our 2018 Annual Report on Form 10-K filed with the SEC on April 1, 2019 are not the only risks that we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition and future results of operations. The following information updates, and should be read in conjunction with, the risk factors previously disclosed in Item 1A, subsection “Risk Factors” to Part I of our 2018 Annual Report on Form 10-K filed with the SEC on April 1, 2019. Except as set forth below, there have been no material changes to the risk factors previously disclosed under the caption “Risk Factors” in our 2018 Annual Report on Form 10-K.

We recently completed the acquisition of Spitfire Pharma, Inc. and the failure to successfully integrate its operations could adversely affect our future results.

Our success will depend, in significant part, on our ability to realize the anticipated benefits from combining our operations with the operations of Spitfire Pharma, Inc. (“Spitfire”). The failure to integrate successfully and to manage successfully the challenges presented by the integration process may result in our failure to achieve some or all of the anticipated benefits of the merger. Potential difficulties that may be encountered in the integration process include the following:

 

increased operating complexity of our business, requiring greater personnel and resources;

 

increased costs in connection with the acquisition and integration;

 

using our cash and assets efficiently to develop our business;

 

uncertainty related to the value or benefits of intellectual property or technologies acquired;

 

potential unknown or currently unquantifiable liabilities associated with the acquisition and our operations; and

 

performance shortfalls as a result of the diversion of the management’s attention caused by integrating the companies’ operations.

 

If the acquired business is not successfully integrated into our company, our business, financial condition and results of operations could be materially adversely affected, as well as our professional reputation. Furthermore, if we are unable to successfully integrate the acquired business and operations, or if there are delays in combining the businesses, the anticipated benefits of the acquisition may not be realized fully or at all or may take longer to realize than expected. Successful integration of the acquired business will depend on our ability to manage these operations, to realize opportunities for revenue growth presented by our products and eliminate certain excess costs of the acquired business.

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3.

Default upon Senior Securities

None

Item 4.

Mine Safety Disclosures

Not applicable.

Item 5.

Other Information

None.

18


 

 

Item 6.

Exhibits

 

No.

 

Description

 

 

 

 

 

 

 

 

 

10.1

 

Transition Services Agreement, by and between the Company and Sybil Tasker, M.D., MPH, dated June 17, 2019.

 

 

 

 

 

10.2

 

Release of Claims Agreement, by and between the Company and Dr. Tasker, dated June 17, 2019.

 

 

 

 

 

10.3

 

Employment Agreement, dated June 10, 2019, by and between the Company and William Brown (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K filed on June 12, 2019).

 

 

 

 

 

31.1

  

Certification of Principal Executive Officer Pursuant to SEC Rule  13a-14(a)/15d-14(a)

 

 

 

 

31.2

  

Certification of Principal Financial Officer Pursuant to SEC Rule  13a-14(a)/15d-14(a)

 

 

 

 

32.1

  

Certification Pursuant to Section  1350 of Chapter  63 of Title  18 of the United States Code

 

 

 

 

32.2

  

Certification Pursuant to Section  1350 of Chapter  63 of Title  18 of the United States Code

 

 

 

 

101.INS

  

Instance Document

 

 

 

 

101.SCH

  

XBRL Taxonomy Extension Schema Document

 

 

 

 

101.CAL

  

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

 

101.DEF

  

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

 

101.LAB

  

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

 

101.PRE

  

XBRL Taxonomy Extension Presentation Linkbase Document

 

 

#  This certification will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorcporated by reference into such filing.

 

 

19


 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused the report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

ALTIMMUNE, INC.

 

 

 

 

Dated: August 13, 2019

By:

 

/s/ Vipin K. Garg

 

Name:

 

Vipin K. Garg

 

Title:

 

President and Chief Executive Officer (Principal Executive Officer)

 

 

 

 

Dated: August 13, 2019

By:

 

/s/ Will Brown

 

Name:

 

Will Brown

 

Title:

 

Chief Financial Officer (Principal Financial and Accounting Officer)

 

 

 

 

 

 

20