Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

FOR THE QUARTERLY PERIOD ENDED: June 30, 2012

 

or

 

o         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: 001-32325

 

CALLISTO PHARMACEUTICALS, INC.

(Exact name of Registrant as specified in its charter)

 

Delaware

 

13-3894575

(State or Other Jurisdiction of
Incorporation or Organization)

 

(I.R.S. Employer
Identification No.)

 

420 Lexington Avenue, Suite 1609, New York, New York 10170

(Address of principal executive offices) (Zip Code)

 

(212) 297-0010

(Registrant’s telephone number)

 

 

(Former Name, Former Address and Former Fiscal Year, if changed since last report)

 

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 x  No o

 

Indicate by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).  Yes x  No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer o

 

Accelerated filer o

 

 

 

Non-accelerated filer o

 

Smaller reporting company x

(Do not check if a smaller reporting company)

 

 

 

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

 

The number of the registrant’s shares of common stock outstanding was 158,965,071 as of August 17, 2012.

 

 

 



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.

 

FORM 10-Q

 

CONTENTS

 

 

 

 

Page

PART I—FINANCIAL INFORMATION

 

 

Item 1.

Financial Statements

 

 

 

Condensed Consolidated Balance Sheets as of June 30, 2012 (unaudited) and December 31, 2011

 

4

 

Condensed Consolidated Statements of Operations for the Three Months and Six Months Ended June 30, 2012 and 2012 (unaudited) and the period June 5, 1996 (Inception) to June 30, 2012 (unaudited)

 

5

 

Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the period June 5, 1996 (Inception) to June 30, 2012 (period from January 1 to June 30, 2012 is unaudited)

 

6

 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2012 and 2011 (unaudited) and for the period June 5, 1996 (Inception) to June 30, 2012 (unaudited)

 

15

 

Notes to Condensed Consolidated Financial Statements (unaudited)

 

17

Item 2.

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

 

26

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

28

Item 4.

Controls and Procedures

 

28

PART II—OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

30

Item 1A.

Risk Factors

 

30

Item 6.

Exhibits

 

30

Signatures

 

 

31

 

2



Table of Contents

 

INTRODUCTORY NOTE

 

This Report on Form 10-Q for Callisto Pharmaceuticals, Inc. (“Callisto” or the “Company”) may contain forward-looking statements. You can identify these statements by forward-looking words such as “plan,” “may,” “will,” “expect,” “intend,” “anticipate,” “believe,” “estimate” and “continue” or similar words. Forward-looking statements include information concerning possible or assumed future business success or financial results. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. We believe that it is important to communicate future expectations to investors. However, there may be events in the future that we are not able to accurately predict or control. Accordingly, we do not undertake any obligation to update any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.

 

The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties set forth under “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2011, as filed with the Securities Exchange Commission on March 30, 2012.  Accordingly, to the extent that this Report contains forward-looking statements regarding the financial condition, operating results, business prospects or any other aspect of the Company, please be advised that Callisto’s actual financial condition, operating results and business performance may differ materially from that projected or estimated by the Company in forward-looking statements.

 

On May 9, 2012, Callisto deconsolidated Synergy and derecognized the Synergy assets, liabilities, and non-controlling interest from its financial statements. All drug candidates to treat GI disorders and diseases, currently plecanatide and SP-333, are being developed exclusively by Synergy Pharmaceuticals, Inc., our former controlled subsidiary (“Synergy”). Use of the terms “we”, “our” or “us” in connection with GI drug candidates discussed herein refer to research and development activities and plans of Synergy.

 

3



Table of Contents

 

PART I—FINANCIAL INFORMATION

 

Item 1.    Financial Statements

 

CALLISTO PHARMACEUTICALS, INC.

(A Development Stage Company)

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

 

June 30, 2012

 

December 31, 2011

 

 

 

(Unaudited)

 

 

 

ASSETS

 

 

 

 

 

Current Assets:

 

 

 

 

 

Cash and cash equivalents

 

$

120

 

$

13,244,961

 

Prepaid expenses and other

 

 

796,028

 

Tax credits receivable

 

 

377,865

 

 

 

 

 

 

 

Total Current Assets

 

120

 

14,418,854

 

Equity investment in Synergy

 

117,814,450

 

 

Property and equipment, net

 

 

5,774

 

Security deposits

 

73,715

 

87,740

 

 

 

 

 

 

 

Total Assets

 

$

117,888,285

 

$

14,512,368

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

Accounts payable

 

$

1,710,216

 

$

3,206,827

 

Accrued expenses

 

332,507

 

1,457,427

 

Total Current Liabilities

 

2,042,723

 

4,664,254

 

Derivative financial instruments, at estimated fair value—warrants

 

 

3,325,114

 

Due to related party

 

1,936,610

 

 

 

 

 

 

 

 

Total Liabilities

 

3,979,333

 

7,989,368

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ Deficit:

 

 

 

 

 

Series A convertible preferred stock, par value $0.0001, 700,000 shares authorized, 8,000 shares outstanding at June 30, 2012 and December 31, 2011

 

1

 

1

 

Common stock, par value of $.0001 per share: 225,000,000 shares authorized; 158,516,071 shares outstanding at June 30, 2012 and December 31, 2011

 

15,852

 

15,852

 

Additional paid-in capital

 

169,106,403

 

168,531,201

 

Deficit accumulated during development stage

 

(55,213,304

)

(142,366,313

)

 

 

 

 

 

 

Total Callisto Stockholders’ Equity

 

113,908,952

 

26,180,741

 

Non-controlling interest

 

 

(19,657,741

)

 

 

 

 

 

 

Total Stockholders’ Equity

 

113,908,952

 

6,523,000

 

 

 

 

 

 

 

 

 

$

117,888,285

 

$

14,512,368

 

 

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

 

4



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.

(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(Unaudited)

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

June 5, 1996
(Inception) to

 

 

 

2012

 

2011

 

2012

 

2011

 

June 30, 2012

 

Revenues

 

$

 

$

 

$

 

$

 

$

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

2,542,089

 

2,356,099

 

7,880,229

 

3,728,027

 

66,974,746

 

Government grants

 

 

 

3,508

 

 

(1,131,810

)

Purchased in process research and development

 

 

 

 

 

6,944,553

 

General and administrative

 

805,193

 

1,875,688

 

2,758,502

 

3,835,532

 

63,131,159

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(3,347,282

)

(4,231,787

)

(10,642,239

)

(7,563,559

)

(135,918,648

)

Gain on deconsolidation of Synergy

 

120,393,000

 

 

120,393,000

 

 

120,393,000

 

Loss related to equity method investment

 

(2,390,000

)

 

(2,390,000

)

 

(2,390,000

)

Interest and investment income

 

16,039

 

3

 

20,942

 

54

 

937,519

 

Tax credit (expense)

 

(224,963

)

 

(224,963

)

 

1,168,256

 

Other income

 

85,180

 

6,208

 

85,180

 

(6,206

)

(857,944

)

Loss on debt extinguishment

 

 

 

 

 

(2,099,892

)

Change in fair value of derivative instruments

 

(439,116

)

(697,660

)

(431,170

)

(1,036,375

)

(17,341,455

)

 

 

 

 

 

 

 

 

 

 

 

 

Net income/(loss)

 

114,092,858

 

(4,923,236

)

106,810,750

 

(8,606,086

)

(36,109,164

)

Add: Net Loss (income) of subsidiary attributable to non-controlling interest

 

2,817,956

 

2,422,640

 

6,957,805

 

4,344,123

 

26,615,546

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income/(loss) attributable to Callisto

 

116,910,814

 

(2,500,596

)

113,768,555

 

(4,261,963

)

(9,493,618

)

Series A Preferred stock conversion rate change and beneficial conversion feature accreted as a dividend

 

 

 

 

 

(5,025,849

)

Series B Preferred stock conversion rate change and beneficial conversion feature accreted as a dividend

 

 

 

 

 

(12,174,391

)

Cumulative effect of adopting ASC Topic 815 January 1, 2009

 

 

 

 

 

(1,903,900

)

 

 

 

 

 

 

 

 

 

 

 

 

Net income/(loss) available to Callisto common stockholders

 

$

116,910,814

 

$

(2,500,596

)

$

113,768,555

 

$

(4,261,963

)

$

(28,597,758

)

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding

 

 

 

 

 

 

 

 

 

 

 

basic

 

158,516,071

 

158,506,181

 

158,516,071

 

158,078,170

 

 

 

diluted

 

158,629,281

 

158,506,181

 

158,629,281

 

158,078,170

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income/(loss) per common share

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.74

 

$

(0.02

)

$

0.72

 

$

(0.03

)

 

 

Diluted

 

$

0.74

 

$

(0.02

)

$

0.72

 

$

(0.03

)

 

 

 

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

 

5



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.

(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN

STOCKHOLDERS’ EQUITY (DEFICIT)

 

(Unaudited)

 

 

 

Preferred
Shares

 

Preferred
Stock,
Par Value

 

Common
Shares

 

Common
Stock,
Par Value

 

Additional
Paid in Capital

 

Balance at inception, June 5, 1996

 

 

$

 

 

$

 

$

 

Net loss for the year

 

 

 

 

 

 

 

 

 

 

 

Issuance of founder shares

 

 

 

2,642,500

 

264

 

528

 

Common stock issued

 

 

 

1,356,194

 

136

 

272

 

Common stock issued via private placement

 

 

 

1,366,667

 

137

 

1,024,863

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 1996

 

 

 

5,365,361

 

537

 

1,025,663

 

Net loss for the year

 

 

 

 

 

 

Common stock issued via private placement

 

 

 

1,442,666

 

144

 

1,081,855

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 1997

 

 

 

6,808,027

 

681

 

2,107,518

 

Net loss for the year

 

 

 

 

 

 

Amortization of Stock based Compensation

 

 

 

 

 

52,778

 

Common stock issued via private placement

 

 

 

1,416,667

 

142

 

1,062,358

 

Common stock issued for services

 

 

 

788,889

 

79

 

591,588

 

Common stock repurchased and cancelled

 

 

 

(836,792

)

(84

)

(96,916

)

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 1998

 

 

 

8,176,791

 

818

 

3,717,326

 

Net loss for the year

 

 

 

 

 

 

Deferred Compensation—stock options

 

 

 

 

 

9,946

 

Amortization of Stock based Compensation

 

 

 

 

 

 

Common stock issued for services

 

 

 

 

 

3,168,832

 

Common stock issued via private placement

 

 

 

346,667

 

34

 

259,966

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 1999

 

 

 

8,523,458

 

852

 

7,156,070

 

Net loss for the year

 

 

 

 

 

 

Amortization of Stock based Compensation

 

 

 

 

 

 

Common stock issued

 

 

 

4,560,237

 

455

 

250,889

 

Other

 

 

 

 

 

432

 

Preferred shares issued

 

3,485,299

 

348

 

 

 

5,986,302

 

Preferred stock issued for services

 

750,000

 

75

 

 

 

1,124,925

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2000

 

4,235,299

 

423

 

13,083,695

 

1,307

 

14,518,618

 

Net loss for the year

 

 

 

 

 

 

Deferred Compensation—stock Options

 

 

 

 

 

20,000

 

Amortization of Stock based Compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2001

 

4,235,299

 

423

 

13,083,695

 

1,307

 

14,538,618

 

Net loss for the year

 

 

 

 

 

 

Amortization of Stock based Compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2002

 

4,235,299

 

$

423

 

13,083,695

 

$

1,307

 

$

14,538,618

 

 

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

 

6



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.
(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY (DEFICIT) (Continued)

 

 

 

Unamortized Deferred
Stock Based
Compensation

 

Deficit Accumulated
during the Development
Stage

 

Total Stockholders’
Equity

 

Balance at inception, June 5, 1996

 

$

 

$

 

$

 

Net loss for the year

 

 

 

(404,005

)

(404,005

)

Issuance of founder shares

 

 

 

792

 

Common stock issued

 

 

 

408

 

Common stock issued via private placement

 

 

 

1,025,000

 

 

 

 

 

 

 

 

 

Balance, December 31, 1996

 

 

(404,005

)

622,195

 

Net loss for the year

 

 

(894,505

)

(894,505

)

Common stock issued via private placement

 

 

 

1,081,999

 

 

 

 

 

 

 

 

 

Balance, December 31, 1997

 

 

(1,298,510

)

809,689

 

Net loss for the year

 

 

(1,484,438

)

(1,484,438

)

Amortization of Stock based Compensation

 

 

 

52,778

 

Common stock issued

 

 

 

 

 

1,062,500

 

Common stock issued for services

 

 

 

591,667

 

Common Stock repurchased and cancelled

 

 

 

(97,000

)

 

 

 

 

 

 

 

 

Balance, December 31, 1998

 

 

(2,782,948

)

935,196

 

Net loss for the year

 

 

(4,195,263

)

(4,195,263

)

Deferred Compensation—stock options

 

(9,946

)

 

 

Amortization of Stock based Compensation

 

3,262

 

 

3,262

 

Common stock issued for services

 

 

 

3,168,832

 

Common stock issued via private placement

 

 

 

260,000

 

 

 

 

 

 

 

 

 

Balance, December 31, 1999

 

(6,684

)

(6,978,211

)

172,027

 

Net loss for the year

 

 

 

(2,616,261

)

(2,616,261

)

Amortization of Stock based Compensation

 

4,197

 

 

 

4,197

 

Common stock issue

 

 

 

251,344

 

Other

 

 

 

432

 

Preferred shares issued

 

 

 

5,986,650

 

Preferred stock issued for services

 

 

 

1,125,000

 

 

 

 

 

 

 

 

 

Balance, December 31, 2000

 

(2,487

)

(9,594,472

)

4,923,389

 

Net loss for the year

 

 

(1,432,046

)

(1,432,046

)

Deferred Compensation—stock options

 

(20,000

)

 

 

Amortization of Stock based Compensation

 

22,155

 

 

22,155

 

 

 

 

 

 

 

 

 

Balance, December 31, 2001

 

(332

)

(11,026,518

)

3,513,498

 

Net loss for the year

 

 

(1,684,965

)

(1,684,965

)

Amortization of Stock based Compensation

 

332

 

 

332

 

 

 

 

 

 

 

 

 

Balance, December 31, 2002

 

$

 

$

(12,711,483

)

$

1,828,865

 

 

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

 

7



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.
(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY (DEFICIT) (Continued)

 

 

 

Preferred
Stock

 

Preferred
Stock Par
Value

 

Common
Stock

 

Common
Stock
Par
Value

 

Additional
Paid in
Capital

 

Unamortized
Deferred
Stock Based
Compensation

 

Deficit
Accumulated
during the
Development
Stage

 

Total
Stockholders’
Equity

 

Balance December 31, 2002

 

4,235,299

 

$

423

 

13,083,695

 

$

1,307

 

$

14,538,618

 

$

 

$

(12,711,483

)

$

1,828,865

 

Net loss for the year

 

 

 

 

 

 

 

(13,106,247

)

(13,106,247

)

Conversion of preferred stock in connection with the Merger

 

(4,235,299

)

(423

)

4,235,299

 

423

 

 

 

 

 

Common stock issued to former Synergy stockholders

 

 

 

 

4,329,927

 

432

 

6,494,458

 

 

 

6,494,890

 

Common stock issued in exchange for Webtronics common stock

 

 

 

 

1,503,173

 

150

 

(150

)

 

 

 

Deferred Compensation—stock options

 

 

 

 

 

 

9,313,953

 

(9,313,953

)

 

 

Amortization of deferred Stock based Compensation

 

 

 

 

 

 

 

3,833,946

 

 

3,833,946

 

Private placement of common stock, net

 

 

 

2,776,666

 

278

 

3,803,096

 

 

 

3,803,374

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2003

 

 

$

 

25,928,760

 

$

2,590

 

$

34,149,975

 

$

(5,480,007

)

$

(25,817,730

)

$

2,854,828

 

 

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

 

8



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.
(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY (DEFICIT) (Continued)

 

 

 

Common
Stock

 

Common
Stock
Par Value

 

Additional
Paid in
Capital

 

Unamortized
Deferred
Stock Based
Compensation

 

Deficit
Accumulated
during the
Development
Stage

 

Total
Stockholders’
Equity

 

Balance, December 31, 2003

 

25,928,760

 

$

2,590

 

$

34,149,975

 

$

(5,480,007

)

$

(25,817,730

)

$

2,854,828

 

Net loss for the year

 

 

 

 

 

(7,543,467

)

(7,543,467

)

Amortization of deferred Stock-based compensation expense

 

 

 

 

3,084,473

 

 

3,084,473

 

Variable accounting for stock options

 

 

 

(816,865

)

 

 

(816,865

)

Stock-based compensation net of forfeitures

 

 

 

240,572

 

93,000

 

 

333,572

 

Common stock issued via private placements, net

 

3,311,342

 

331

 

6,098,681

 

 

 

6,099,012

 

Warrant and stock-based compensation for services in connection with the Merger

 

 

 

269,826

 

 

 

269,826

 

Common stock returned from former Synergy stockholders

 

(90,000

)

(9

)

(159,083

)

 

 

(159,092

)

Stock issued for patent rights

 

25,000

 

3

 

56,247

 

 

 

56,250

 

Common stock issued for services

 

44,000

 

7

 

70,833

 

 

 

70,840

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2004

 

29,219,102

 

$

2,922

 

$

39,910,186

 

$

(2,302,534

)

$

(33,361,197

)

$

4,249,377

 

 

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

 

9



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.

(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY (DEFICIT) (Continued)

 

 

 

Common
Stock

 

Common
Stock
Par Value

 

Additional
Paid in
Capital

 

Unamortized
Deferred
Stock Based
Compensation

 

Deficit
Accumulated
during the
Development
Stage

 

Total
Stockholders’
Equity
(Deficit)

 

Balance, December 31, 2004

 

29,219,102

 

$

2,922

 

$

39,910,186

 

$

(2,302,534

)

$

(33,361,197

)

$

4,249,377

 

Net loss for the year

 

 

 

 

 

(11,779,457

)

(11,779,457

)

Deferred stock-based compensation—new grants

 

 

 

1,571,772

 

(1,571,772

)

 

 

Amortization of deferred stock-based compensation

 

 

 

 

2,290,843

 

 

2,290,843

 

Variable accounting for stock options

 

 

 

75,109

 

 

 

75,109

 

Common stock issued via private placement:

 

 

 

 

 

 

 

 

 

 

 

 

 

March 2005

 

1,985,791

 

198

 

3,018,203

 

 

 

3,018,401

 

August 2005

 

1,869,203

 

187

 

1,812,940

 

 

 

1,813,127

 

Finders fees and expenses

 

 

 

(176,249

)

 

 

(176,249

)

Exercise of common stock warrant

 

125,000

 

13

 

128,737

 

 

 

128,750

 

Common stock issued for services

 

34,000

 

3

 

47,177

 

 

 

47,180

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2005

 

33,233,096

 

$

3,323

 

$

46,387,875

 

$

(1,583,463

)

$

(45,140,654

)

$

(332,919

)

 

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

 

10



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.

(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN

STOCKHOLDERS’ EQUITY (DEFICIT) (Continued)

 

 

 

Series A
Convertible
Preferred
Shares

 

Series A
Convertible
Preferred
Stock

 

Common
Stock

 

Common
Stock
Par
Value

 

Additional
Paid in
Capital

 

Unamortized
Deferred
Stock Based
Compensation

 

Deficit
Accumulated
during the
Development
Stage

 

Total
Stockholders’
Equity
(Deficit)

 

Balance, December 31, 2005

 

 

$

 

33,233,096

 

$

3,323

 

$

46,387,875

 

$

(1,583,463

)

$

(45,140,654

)

$

(332,919

)

Net loss for the year

 

 

 

 

 

 

 

(12,919,229

)

(12,919,229

)

Reclassification of deferred unamortized stock-based compensation upon adoption of FAS 123R

 

 

 

 

 

(1,583,463

)

1,583,463

 

 

 

Stock based compensation expense

 

 

 

 

 

2,579,431

 

 

 

2,579,431

 

Common stock issued via private placement:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

February 2006

 

 

 

 

4,283,668

 

428

 

5,139,782

 

 

 

 

 

5,140,210

 

Finders fees and expenses

 

 

 

 

 

 

(561,808

)

 

 

(561,808

)

April 2006

 

 

 

666,667

 

67

 

799,933

 

 

 

 

 

800,000

 

Finders fees and expenses

 

 

 

 

 

(41,000

)

 

 

(41,000

)

Waiver and Lock-up Agreement

 

 

 

740,065

 

74

 

579,622

 

 

 

579,696

 

Common stock issued for services

 

 

 

87,000

 

9

 

121,101

 

 

 

121,110

 

Exercise of common stock warrants

 

 

 

184,500

 

18

 

190,017

 

 

 

190,035

 

Series A convertible preferred stock issued via private placement:

 

574,350

 

57

 

 

 

5,743,443

 

 

 

5,743,500

 

Finders fees and expenses

 

11,775

 

1

 

 

 

(448,909

)

 

 

(448,908

)

Detachable warrants

 

 

 

 

 

2,384,485

 

 

 

2,384,485

 

Beneficial conversion feature accreted as a dividend

 

 

 

 

 

 

 

(2,384,485

)

(2,384,485

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2006

 

586,125

 

$

58

 

39,194,996

 

$

3,919

 

$

61,290,509

 

$

 

$

(60,444,368

)

$

850,118

 

 

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

 

11



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.

(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN

STOCKHOLDERS’ EQUITY (DEFICIT) (Continued)

 

 

 

Series A
Convertible
Preferred
Shares

 

Series A
Convertible
Preferred
Stock,
Par Value

 

Series B
Convertible
Preferred
Shares

 

Series B
Convertible
Preferred
Stock,
Par Value

 

Common
Shares

 

Common
Stock,
Par
Value

 

Additional
Paid in
Capital

 

Deficit
Accumulated
during the
Development
Stage

 

Total
Stockholders’
Equity

 

Balance, December 31, 2006

 

586,125

 

$

58

 

 

$

 

39,194,996

 

$

3,919

 

$

61,290,509

 

$

(60,444,368

)

$

850,118

 

Net loss for the year

 

 

 

 

 

 

 

 

(7,887,265

)

(7,887,265

)

Stock-based compensation expense

 

 

 

 

 

 

 

591,561

 

 

591,561

 

Common stock issued for services

 

 

 

 

 

80,000

 

8

 

36,792

 

 

36,800

 

Series A convertible preferred stock, issued via private placement

 

28,000

 

4

 

 

 

 

 

279,997

 

 

280,001

 

Finders fees and expenses, Series A private placement

 

 

 

 

 

 

 

(36,400

)

 

(36,400

)

Conversion of Series A preferred stock to common stock

 

(395,450

)

(40

)

 

 

7,668,165

 

767

 

(727

)

 

 

Beneficial conversion feature accreted as a dividend to Series A preferred stock

 

 

 

 

 

 

 

2,504,475

 

(2,504,475

)

 

Series B convertible preferred stock, issued via private placement

 

 

 

1,147,050

 

115

 

 

 

11,470,385

 

 

11,470,500

 

Finders fees and expenses, Series B private placement

 

 

 

 

 

 

 

(920,960

)

 

(920,960

)

Beneficial conversion feature accreted as a dividend to Series B preferred stock

 

 

 

 

 

 

 

10,495,688

 

(10,495,688

)

 

Change in fair value of Series B warrants from date of issuance to expiration of put option

 

 

 

 

 

 

 

(2,591,005

)

 

(2,591,005

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2007

 

218,675

 

22

 

1,147,050

 

115

 

46,943,161

 

4,694

 

83,120,315

 

(81,331,796

)

1,793,350

 

Net loss for the year

 

 

 

 

 

 

 

 

(9,655,471

)

(9,655,471

)

Recapitalization of majority owned subsidiary via private placements of common stock

 

 

 

 

 

 

 

2,951,913

 

 

2,951,913

 

Minority interest in equity of subsidiary acquired

 

 

 

 

 

 

 

(42,824

)

 

(42,824

)

Stock-based compensation expense

 

 

 

 

 

 

 

589,063

 

 

589,063

 

Proceeds from issuance of 11% Notes attributable to detachable warrants

 

 

 

 

 

 

 

181,732

 

 

181,732

 

Conversion of Series A preferred stock to common stock

 

(120,675

)

(12

)

 

 

2,413,500

 

241

 

(229

)

 

 

Conversion of Series B preferred stock to common stock

 

 

 

(10,000

)

(1

)

200,000

 

20

 

(19

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2008

 

98,000

 

$

10

 

1,137,050

 

$

114

 

49,556,661

 

$

4,955

 

$

86,799,951

 

$

(90,987,267

)

$

(4,182,237

)

 

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

 

12



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.
(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY (DEFICIT) (Continued)

 

(Unaudited)

 

 

 

Series A
Convertible
Preferred
Shares

 

Series A
Convertible
Preferred
Stock

 

Series B
Convertible
Preferred
Shares

 

Series B
Convertible
Preferred
Stock

 

Common
Shares

 

Common
Stock
Par Value

 

Additional
Paid in
Capital

 

Deficit
Accumulated
during the
Development
Stage

 

Non-
Controlling
Interest

 

Total
Stockholders’
Equity
(Deficit)

 

Balance, December 31, 2008

 

98,000

 

$

10

 

1,137,050

 

$

114

 

49,556,661

 

4,955

 

$

86,799,951

 

$

(90,987,267

)

$

 

$

(4,182,237

)

Cumulative effect of adoption of ASC Topic 815

 

 

 

 

 

 

 

(181,732

)

(1,903,900

)

 

(2,085,632

)

Net Loss

 

 

 

 

 

 

 

 

(15,073,021

)

(3,282,393

)

(18,355,414

)

Stock based compensation expense

 

 

 

 

 

 

 

1,119,856

 

 

 

1,119,856

 

Conversion of Series A preferred stock to common stock

 

(35,000

)

(4

)

 

 

894,445

 

89

 

(85

)

 

 

 

Conversion of Series B preferred stock to common stock

 

 

 

(122,884

)

(12

)

2,963,236

 

296

 

(284

)

 

 

 

Private placements of common stock of majority owned subsidiary

 

 

 

 

 

 

 

15,970,100

 

 

 

15,970,100

 

Fees and expenses associated with private placements of majority owned subsidiary

 

 

 

 

 

 

 

(260,002

)

 

 

(260,002

)

Preferred Stock dividend attributable to reset of conversion price in conjunction with waiver of liquidation preference

 

 

 

 

 

 

 

1,815,592

 

(1,815,592

)

 

 

Cashless Conversion of Warrants to Common Stock

 

 

 

 

 

193,769

 

19

 

(19

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance December 31, 2009

 

63,000

 

$

6

 

1,014,166

 

$

102

 

53,608,111

 

$

5,359

 

$

105,263,377

 

$

(109,779,780

)

$

(3,282,393

)

$

(7,793,329

)

Net Loss

 

 

 

 

 

 

 

 

(25,793,488

)

(7,854,264

)

(33,647,752

)

Stock based compensation expense

 

 

 

 

 

 

 

854,651

 

 

 

854,651

 

Conversion of Series A preferred stock to common stock

 

(55,000

)

(5

)

 

 

1,527,777

 

153

 

(148

)

 

 

 

Conversion of Series B preferred stock to common stock

 

 

 

(1,014,166

)

(102

)

28,171,278

 

2,817

 

(2,715

)

 

 

 

Common shares in exchange for modification of convertible notes

 

 

 

 

 

265,770

 

27

 

100,169

 

 

 

100,196

 

Extinguishment on debt

 

 

 

 

 

 

 

2,809,531

 

 

 

2,809,531

 

Cashless conversion of Warrants to common stock upon extinguishment of convertible notes

 

 

 

 

 

72,355,769

 

7,236

 

(7,236

)

 

 

 

Warrants exchanged

 

 

 

 

 

1,505,699

 

151

 

(151

)

 

 

 

Direct offering of common stock of controlled subsidiary

 

 

 

 

 

 

 

7,179,000

 

 

 

7,179,000

 

Fair value of warrants issued in connection with controlled subsidiary registered direct offerings reclassified to derivative liability

 

 

 

 

 

 

 

(3,784,743

)

 

 

(3,784,743

)

Fees and expenses associated with direct offering of controlled subsidiary

 

 

 

 

 

 

 

(468,130

)

 

 

(468,130

)

Reclassification of derivative liability to equity upon termination of price protection

 

 

 

 

 

 

 

27,511,730

 

 

 

27,511,730

 

Common stock issued as settlement for director’s fees

 

 

 

 

 

75,000

 

8

 

41,117

 

 

 

41,125

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance December 31, 2010

 

8,000

 

$

1

 

 

$

 

157,509,404

 

$

15,751

 

$

139,496,452

 

$

(135,573,268

)

$

(11,136,657

)

$

(7,197,721

)

 

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

 

13



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.
(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY (DEFICIT) (Continued)

 

(Unaudited)

 

 

 

Series A
Convertible
Preferred
Shares

 

Series A
Convertible
Preferred
Stock

 

Series B
Convertible
Preferred
Shares

 

Series B
Convertible
Preferred
Stock

 

Common
Shares

 

Common
Stock
Par Value

 

Additional
Paid in
Capital

 

Deficit
Accumulated
during the
Development
Stage

 

Non-
Controlling
Interest

 

Total
Stockholders’
Equity
(Deficit)

 

Balance December 31, 2010

 

8,000

 

$

1

 

 

 

157,509,404

 

$

15,751

 

$

139,496,452

 

$

(135,573,268

)

$

(11,136,657

)

(7,197,721

)

Net Loss

 

 

 

 

 

 

 

 

(6,793,045

)

(8,521,084

)

(15,314,129

)

Stock based compensation expense

 

 

 

 

 

 

 

424,168

 

 

 

424,168

 

Common stock issued for services

 

 

 

 

 

850,000

 

85

 

532,915

 

 

 

533,000

 

Value of common stock issued by controlled subsidiary for consulting services provided

 

 

 

 

 

 

 

341,295

 

 

 

341,295

 

Placement of common stock of controlled subsidiary

 

 

 

 

 

 

 

34,369,064

 

 

 

34,369,064

 

Fees and expenses associated with direct offering of controlled subsidiary

 

 

 

 

 

 

 

(2,148,384

)

 

 

(2,148,384

)

Warrant exercise

 

 

 

 

 

 

 

 

 

106,667

 

11

 

53,323

 

 

 

 

 

53,334

 

Warrants issued in connection with controlled subsidiary registered direct offering reclassified to derivative liability-net

 

 

 

 

 

 

 

(5,094,186

)

 

 

(5,094,186

)

Exercise of warrants-controlled subsidiary

 

 

 

 

 

 

 

415,309

 

 

 

415,309

 

Common stocks issued for settlement of directors’ fee

 

 

 

 

 

50,000

 

5

 

41,245

 

 

 

41,250

 

Sale of option to purchase shares of controlled subsidiary

 

 

 

 

 

 

 

100,000

 

 

 

100,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance December 31, 2011

 

8,000

 

1

 

 

 

158,516,071

 

15,852

 

168,531,201

 

(142,366,313

)

(19,657,741

)

6,523,000

 

Net income/(loss) for the period

 

 

 

 

 

 

 

 

113,768,555

 

(6,957,805

)

106,810,750

 

Stock based compensation expense

 

 

 

 

 

 

 

482,539

 

 

 

482,539

 

Common stock issued by controlled subsidiary for services rendered

 

 

 

 

 

 

 

92,663

 

 

 

92,663

 

Reclass non-controlling interest upon deconsolidation May 9, 2012

 

 

 

 

 

 

 

 

(26,615,546

)

26,615,546

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance June 30, 2012

 

8,000

 

$

1

 

 

$

 

158,516,071

 

$

15,852

 

$

169,106,403

 

$

(55,213,304

)

$

 

$

113,908,952

 

 

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

 

14



Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.

(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

(Unaudited)

 

 

 

Six months
ended June 30, 2012

 

Six months
ended June 30, 2011

 

Period from
June 5, 1996
(inception) to
June 30, 2012

 

Cash flows from operating activities:

 

 

 

 

 

 

 

Net income/(loss)

 

$

106,810,750

 

$

(8,606,086

)

$

(36,109,164

)

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

Depreciation

 

 

2,634

 

111,458

 

Purchase discount accreted as interest income on U.S.Treasury bills

 

 

 

(26,950

)

Stock-based compensation expense

 

650,202

 

469,444

 

21,583,041

 

Purchased in-process research and development

 

 

 

6,841,053

 

Interest expense on notes

 

 

 

759,400

 

Loss on disposal of property and equipment

 

5,774

 

 

5,774

 

Stock-based liquidated damages

 

 

 

579,696

 

Change in fair value of derivative instruments—warrants

 

431,170

 

1,036,375

 

17,341,455

 

Loss on debt extinguishment

 

 

 

 

 

2,099,892

 

Net liabilities assumed in excess of assets acquired in merger

 

 

 

(282,752

)

Gain on deconsolidation of Synergy

 

(120,393,000

)

 

(120,393,000

)

Loss related to equity method investment

 

2,390,000

 

 

2,390,000

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Prepaid expenses

 

721,028

 

158,004

 

 

Tax credit receivable

 

377,865

 

531,127

 

 

Security deposit

 

14,025

 

 

73,715

 

Accounts payable and accrued expenses

 

(6,192,265

)

(336,641

)

(1,498,137

)

Due to related party

 

395,153

 

 

395,153

 

Total Adjustments

 

(120,055,591

)

1,860,943

 

(68,623,175

)

Net cash used in operating activities

 

(13,244,841

)

(6,745,143

)

(104,732,339

)

Cash flows from investing activities:

 

 

 

 

 

 

 

Short term investments—purchased

 

 

 

(5,921,825

)

Short term investments—liquidated

 

 

 

5,948,775

 

Acquisition of equipment

 

 

 

(117,233

)

Net cash used in investing activities

 

 

 

(90,283

)

Cash flows from financing activities:

 

 

 

 

 

 

 

Issuance of common and preferred stock

 

 

 

48,719,673

 

Issuance of common stock of controlled subsidiary

 

 

5,461,242

 

60,543,162

 

Proceeds from exercise of warrants of controlled subsidiary

 

 

415,309

 

415,309

 

Selling Agent fees and expenses-combined

 

 

(395,620

)

(5,930,684

)

Proceeds from sale of 11% Notes

 

 

 

603,163

 

Exercise of common stock warrants

 

 

53,334

 

372,119

 

Proceeds from sale of option

 

 

100,000

 

100,000

 

Net cash provided by financing activities

 

 

5,634,265

 

104,822,742

 

Net (decrease) increase in cash and cash equivalents

 

(13,244,841

)

(1,110,878

)

120

 

Cash and cash equivalents at beginning of period

 

13,244,961

 

1,708,982

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at end of period

 

$

120

 

$

598,104

 

$

120

 

 

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

 

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Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.
(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Continued)

 

(Unaudited)

 

 

 

Six months
ended
June 30, 2012

 

Six months
ended
June 30, 2011

 

Period from
June 5, 1996
(inception) to
June 30, 2012

 

Supplementary disclosure of cash flow information:

 

 

 

 

 

 

 

Cash paid for taxes

 

$

42,415

 

$

5,147

 

$

367,299

 

Supplementary disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

 

Series A Preferred stock beneficial conversion feature accreted as a dividend

 

 

 

(4,888,960

)

Series B Preferred stock beneficial conversion feature accreted as a dividend

 

 

 

(10,495,688

)

Series A Preferred stock conversion rate change accreted as a dividend

 

 

 

(136,889

)

Series B Preferred stock conversion rate change accreted as a dividend

 

 

 

(1,678,703

)

Director’s fees settled for shares of common stock

 

 

41,250

 

82,375

 

Cash received in escrow for June 30, 2010 direct registered offering

 

 

2,499,000

 

 

Accrued finders’ fees related to direct registered offering

 

 

261,630

 

 

Common stock issued to extend notes payable

 

 

 

100,196

 

Value of warrants classified as derivative liability - net

 

$

 

$

3,434,172

 

$

20,331,912

 

Value of shares issued for services

 

$

 

$

533,000

 

$

625,663

 

 

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

 

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Table of Contents

 

CALLISTO PHARMACEUTICALS, INC.

(A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

(Unaudited)

 

1. Business overview:

 

Callisto Pharmaceuticals, Inc. (which may be referred to as “Callisto”, “the Company”) is a development stage biopharmaceutical company focused primarily on the development of drugs to treat gastrointestinal (“GI”) disorders and diseases and was incorporated under the laws of the State of Delaware on June 5, 1996 (inception). Since inception, Callisto’s efforts have been principally devoted to research and development, securing and protecting patents and raising capital.

 

From inception through June 30, 2012, Callisto has sustained cumulative net losses attributable to common stockholders of $28,597,758. Callisto’s losses have resulted primarily from expenditures incurred in connection with research and development activities, application and filing for regulatory approval of proposed products, stock-based compensation expense, patent filing and maintenance expenses, purchase of in-process research and development, outside accounting and legal services and regulatory, scientific and financial consulting fees, as well as deemed dividends attributable to the beneficial conversion rights of convertible preferred stock at issuance. From inception through June 30, 2012, Callisto has not generated any revenue from operations. The Company expects to incur additional losses to perform further research and development activities and does not currently have any commercial biopharmaceutical products, and does not expect to have such for several years, if at all.

 

Callisto’s product development efforts are thus in their early stages and Callisto cannot make estimates of the costs or the time they will take to complete. The risk of not completing any program is high because of the many uncertainties involved in bringing new drugs to market including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, the extended regulatory approval and review cycles, the nature and timing of costs and competing technologies being developed by organizations with significantly greater resources.

 

2. Basis of presentation and going concern:

 

These condensed consolidated financial statements include Callisto and one subsidiary Callisto Research Labs, LLC (including its wholly-owned subsidiary, Callisto Pharma, GmbH (Germany—inactive).  All intercompany balances and transactions have been eliminated. These condensed consolidated financial statements do not include all of the information and footnote disclosures required by GAAP for complete financial statements. These statements should be read in conjunction with Callisto’s audited financial statements and notes thereto for the year ended December 31, 2011, included in Form 10-K filed with the SEC on March 30, 2012. Certain items in the prior year’s financial statements have been reclassified to conform to the current year’s presentation.

 

Deconsolidation

 

On May 9, 2012, Callisto’s controlled subsidiary, Synergy Pharmaceuticals, Inc. (“Synergy”) closed an underwritten public offering of 10 million shares of common stock at an offering price of $4.50 per share, resulting in gross proceeds of $45 million before deducting underwriting discounts, commissions and other estimated offering expenses of approximately $3 million. As a result Callisto’s equity ownership decreased to approximately 34% of Synergy and Callisto determined that it no longer had control over the operations and decision making of Synergy. Therefore, Callisto deconsolidated Synergy and derecognized the Synergy assets, liabilities, and non-controlling interest from its financial statements. For the quarter ended June 30, 2012, the gain attributed to the deconsolidation was $120,393,000. As of the date of deconsolidation, May 9, 2012, the Company began accounting for its investment in Synergy under the equity method and accordingly recognized its share of Synergy losses in the amount of $2,390,000 for the period from May 9, 2012 through June 30, 2012. As of June 30, 2012, Callisto’s investment in Synergy was $117,814,450.

 

In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, primarily consisting of normal adjustments, necessary for the fair presentation of the balance sheet and results of operations for the interim periods. The results of operations for the three and six months ended June 30, 2012 are not necessarily indicative of the results of operations to be expected for the full year ending December 31, 2012. The condensed consolidated balance sheet as of December 31, 2011 presented above was derived from the audited consolidated financial statements as of that date.

 

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The condensed consolidated financial statements as of June 30, 2012 and December 31, 2011 have been prepared under the assumption that Callisto will continue as a going concern for the twelve months ending December 31, 2012. Callisto’s ability to continue as a going concern is dependent upon its ability to obtain additional equity or debt financing, attain further operating efficiencies and, ultimately, to generate revenue. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Net cash used in operating activities was $13,244,841 during the six months ended June 30, 2012 as compared to $6,745,143 for the six months ended June 30, 2011 and $104,732,339 during the period from June 5, 1996 (inception) to June 30, 2012. During the three months and six months ended June 30, 2012 Callisto earned net income attributable to common stockholders of $116,910,814 and $113,768,555, respectively and net loss of attributable to common stockholders $28,597,758 during the period from June 5, 1996 (inception) to June 30, 2012, which all included gain recognized upon deconsolidation of $120,393,000. Net losses attributable to common shareholders for the three months and six months ended June 30, 2011 were $2,500,596 and $4,261,963, respectively. To date, Callisto’s sources of cash have been primarily limited to the sale of equity securities and issuance of debt instruments. Net cash provided by financing activities for the six months ended June 30, 2011 and for the period from June 5, 1996 (inception) to June 30, 2012, was $5,634,265, and $104,822,742, respectively. There were no financing activities for the six months ended June 30, 2012.

 

On July 20, 2012, Callisto’s former controlled subsidiary, Synergy Pharmaceuticals, Inc. (Synergy”) entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Callisto. Pursuant to the Merger Agreement, following the satisfaction or waiver of each of the applicable conditions set forth in the Merger Agreement, Callisto and Synergy will merge (the “Merger”), whereupon Callisto’s separate corporate existence will cease and Synergy will continue as the surviving corporation of the Merger. Please see footnote 11for further discussions.

 

3. Recent Accounting Pronouncements

 

In June 2011, the FASB issued ASU No. 2011-05, Presentation of Comprehensive Income (“ASU 2011-05”) which is intended to facilitate the convergence of U.S. GAAP and International Financial Reporting Standards (“IFRS”) as well as to increase the transparency of items reported in other comprehensive income. As a result of ASU 2011-05, all nonowner changes in stockholders’ equity are required to be presented in a single continuous statement of comprehensive income or in two separate but consecutive statements. The option to present other comprehensive income in the statement of changes in equity has been eliminated. ASU 2011-05 is effective for fiscal years beginning after December 15, 2011 and should be applied retrospectively. The Company adopted this standard on January 1, 2012 and the adoption did not have a material impact on the Company’s consolidated financial statements.

 

In May 2011, FASB issued ASU No. 2011-04, “Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs.” ASU 2011-04 amends Topic 820 to provide common fair value measurement and disclosure requirements in U.S. Generally Accepted Accounting Principles (“U.S. GAAP”) and International Financial Reporting Standards. Consequently, the amendments change the wording used to describe many of the requirements in U.S. GAAP for measuring fair value and for disclosing information about fair value measurements, as well as providing guidance on how fair value should be applied where its use is already required or permitted by other standards within U.S. GAAP. ASU No. 2011-04 is to be applied prospectively, and early adoption is not permitted. For public entities, the amendments are effective during interim and annual periods beginning after December 15, 2011. The adoption of ASU No. 2011-04 on January 1, 2012 did not have a material impact on the Company’s consolidated financial statements.

 

In December 2011, the FASB issued ASU 2011-11, “Balance Sheet (Topic 210): Disclosures about Offsetting Assets and Liabilities.” ASU 2011-11 provides for additional disclosures of both gross information and net information about both instruments and transactions eligible for offset in the statement of financial position and instruments and transactions subject to an agreement similar to a master netting arrangement. This scope would include derivatives, sale and repurchase agreements and reverse sale and repurchase agreements, and securities borrowing and securities lending arrangements. The amendments in this Update are effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those annual periods, and disclosures required by these amendments should be provided retrospectively for all comparative periods presented. The adoption of ASU No. 2011-11 is not expected to have a material impact on the Company’s consolidated financial statements.

 

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Table of Contents

 

4. Accounting for share-based payments

 

ASC Topic 718 “Compensation—Stock Compensation” requires companies to measure the cost of employee services received in exchange for the award of equity instruments based on the estimated fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award.

 

ASC Topic 718 did not change the way Callisto accounts for non-employee stock-based compensation. Callisto continues to account for shares of common stock, stock options and warrants issued to non-employees based on the fair value of the stock, stock option or warrant, if that value is more reliably measurable than the fair value of the consideration or services received. The Company accounts for stock options issued and vesting to non-employees in accordance with ASC Topic 505-50 “ Equity-Based Payment to Non-Employees” whereas the value of the stock compensation is based upon the measurement date as determined at either a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. Accordingly the fair value of these options is being “marked to market” quarterly until the measurement date is determined.

 

ASC Topic 718 requires that cash flows resulting from tax deductions in excess of the cumulative compensation cost recognized for options exercised (excess tax benefits) be classified as cash inflows from financing activities and cash outflows from operating activities. Due to Callisto’s accumulated deficit position, no tax benefits have been recognized in the cash flow statement.

 

Callisto accounts for common stock, stock options, and warrants granted to employees and non-employees based on the fair market value of the instrument, using the Black-Scholes option pricing model based on assumptions for expected stock price volatility, term of the option, risk-free interest rate and expected dividend yield, at the grant date.

 

Callisto options

 

Stock based compensation expense, related to Callisto employee and non-employee share based payments, has been recognized in operating results as follow:

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

June 5, 1996
(Inception) to
June 30,

 

 

 

2012

 

2011

 

2012

 

2011

 

2012

 

Employees—included in research and development

 

$

 

$

 

$

 

$

 

$

2,692,258

 

Employees—included in general and administrative

 

5,836

 

14,890

 

11,671

 

20,776

 

4,869,832

 

Subtotal employee stock option grants

 

5,836

 

14,890

 

11,671

 

20,776

 

7,562,090

 

Non-employee—research and development

 

 

 

 

 

102,750

 

Non-employee—general and administrative

 

371

 

180,703

 

82,384

 

152,110

 

10,393,405

 

Subtotal non-employee stock option grants

 

371

 

180,703

 

82,384

 

152,110

 

10,496,155

 

Total stock based compensation expense

 

$

6,207

 

$

195,593

 

$

94,055

 

$

172,886

 

$

18,058,245

 

 

The unrecognized compensation cost related to employee non-vested Callisto stock options outstanding at June 30, 2012, net of expected forfeitures, was $15,184 to be recognized over a weighted average vesting period of approximately half year. No options were granted during the quarter ended June 30, 2012.

 

The estimated fair value of each Callisto stock option award was determined on the date of grant using the Black-Scholes option valuation model with the following weighted-average assumptions during the six months ended June 30, 2011.

 

 

 

Six months ended June 30,

 

 

 

2012

 

2011

 

Risk free interest rate

 

(*)

%

1.85

%

Dividend yield

 

(*)

 

n/a

 

Expected volatility

 

(*)

%

100

%

Expected term

 

(*)

 

5 years

 

 


(*) No options were granted during six months ended June 30, 2012.

 

A summary of stock option activity and of changes in Callisto stock options outstanding under Callisto’s plans is presented below:

 

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Table of Contents

 

 

 

Number of
options

 

Exercise
Price
Per Share

 

Weighted
Average
Exercise
Price
Per Share

 

Aggregate
Intrinsic
Value

 

Weighted
Average
Remaining
Contractual
Term

 

Balance outstanding, December 31, 2011

 

7,435,372

 

$

0.08 - 3.60

 

$

1.49

 

$

7,200

 

3.39

 

Granted

 

 

$

 

$

 

 

 

 

Forfeitures

 

 

$

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance outstanding, June 30, 2012

 

7,435,372

 

$

0.08 - 3.60

 

$

1.49

 

$

162,580

 

2.89

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercisable as of June 30, 2012

 

5,903,372

 

$

0.08 - 3.60

 

$

1.37

 

$

113,210

 

2.67

 

 

Synergy Options

 

ASC Topic 718 “Compensation—Stock Compensation” requires companies to measure the cost of employee services received in exchange for the award of equity instruments based on the estimated fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award. ASC Topic 718 did not change the way Synergy accounts for non-employee stock-based compensation. Synergy continues to account for shares of common stock, stock options and warrants issued to non-employees based on the fair value of the stock, stock option or warrant, if that value is more reliably measurable than the fair value of the consideration or services received. The Company accounts for stock options issued and vesting to non-employees in accordance with ASC Topic 505-50 “Equity-Based Payment to Non-Employees” and accordingly the value of the stock compensation to non-employees is based upon the measurement date as determined at either a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. Accordingly the fair value of these options is being “marked to market” quarterly until the measurement date is determined.

 

ASC Topic 718 requires that cash flows resulting from tax deductions in excess of the cumulative compensation cost recognized for options exercised (excess tax benefits) be classified as cash inflows from financing activities and cash outflows from operating activities. Due to Synergy’s accumulated deficit position, no excess tax benefits have been recognized. Synergy accounts for common stock, stock options, and warrants granted to employees and non-employees based on the fair market value of the instrument, using the Black-Scholes option pricing model based on assumptions for expected stock price volatility, term of the option, risk-free interest rate and expected dividend yield, at the grant date.

 

Synergy adopted the 2008 Equity Compensation Incentive Plan (the “Plan”) during the quarter ended September 30, 2008. Stock options granted under the Plan typically vest after three years of continuous service from the grant date and have a contractual term of ten years.

 

 

 

Three Months
Ended June 30,

 

Six Months
Ended June 30

 

November 15,
2005
(inception) to

 

 

 

2012

 

2011

 

2012

 

2011

 

June 30, 2012

 

Employees—included in research and development

 

$

48,690

 

$

37,157

 

$

164,460

 

$

73,906

 

$

791,242

 

Employees—included in general and administrative

 

33,364

 

45,115

 

127,013

 

89,733

 

901,424

 

Non-employees—included in research and development

 

 

8,456

 

 

16,818

 

168,096

 

Non-employees—included in general and administrative

 

36,022

 

58,370

 

264,674

 

116,101

 

1,664,034

 

 

 

 

 

 

 

 

 

 

 

 

 

Total stock-based compensation expense

 

$

118,076

 

$

149,098

 

$

556,147

 

$

296,558

 

$

3,524,796

 

 

The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model. On May 9, 2012, Callisto deconsolidated Synergy and derecognized the Synergy assets, liabilities, and non-controlling interest from its financial statements.

 

20



Table of Contents

 

5. Investment in Synergy

 

On May 9, 2012, Callisto’s controlled subsidiary, Synergy Pharmaceuticals, Inc. (“Synergy”) closed an underwritten public offering of 10 million shares of common stock at an offering price of $4.50 per share, resulting in gross proceeds of $45 million before deducting underwriting discounts, commissions and other estimated offering expenses of approximately $3 million. As a result, Callisto’s equity ownership decreased to approximately 34% of Synergy and Callisto determined that it no longer had control over the operations and decision making of Synergy. Therefore, Callisto deconsolidated Synergy and derecognized the Synergy assets, liabilities, and non-controlling interest from its financial statements. For the quarter ended June 30, 2012, the gain attributed to the deconsolidation was $120,393,000. As of the date of deconsolidation, May 9, 2012, the Company began accounting for its investment in Synergy under the equity method and accordingly recognized its share of Synergy losses in the amount of $2,390,000 for the period from May 9, 2012 through June 30, 2012.

 

The following table summarizes financial information of Synergy Pharmaceuticals, Inc. (“Synergy”) at June 30, 2012.

 

Income Statement data:

 

 

 

Three Months
Ended June 30,
2012

 

Six Months Ended
June 30, 2012

 

November 15, 2005
(inception) to
June 30, 2012

 

Loss from Operations

 

$

(9,544,756

)

$

(16,614,024

)

$

(92,828,322

)

Total Other Income/(Expense)

 

(1,013,692

)

(967,068

)

5,710,033

 

Net Loss

 

(10,558,448

)

(17,581,092

)

(87,190,110

)

 

Balance Sheet data:

 

 

 

June 30, 2012

 

 

 

(unaudited)

 

Cash and cash equivalents

 

$

27,426,900

 

Available-for-sales securities short term

 

16,149,789

 

Available-for-sale securities long term

 

4,010,787

 

Due from related party (“Callisto Pharmaceuticals”)

 

1,936,609

 

Total Assets

 

50,954,779

 

Total Current Liabilities

 

4,919,563

 

Derivative financial instruments, at estimated fair value-warrants

 

4,803,717

 

Total Liabilities

 

9,723,280

 

Total Stockholders’ Equity

 

41,231,499

 

 

6. Research and Development Expense

 

Research and development costs include expenditures in connection with an in-house research and development laboratory, salaries and staff costs, application and filing for regulatory approval of proposed products, purchased in-process research and development, regulatory and scientific consulting fees, as well as contract research, patient costs, drug formulation and tableting, data collection, monitoring, insurance and FDA consultants.

 

In accordance with FASB ASC Topic 730-10-55, Research and Development, Synergy recorded prepaid research and development costs of $577,745 as of December 31, 2011, for nonrefundable pre-payments for production of drug substance and analytical testing services for its drug candidates. In accordance with this guidance, the Company expenses deferred research and development costs when drug compound is delivered and services are performed. As of June 30, 2012 Synergy’s assets and liabilities have been deconsolidated and as a result there are no prepaid research and development costs on the balance sheet. See Note 5 above.

 

7. Income Taxes

 

During the year ended December 31, 2011, Synergy recorded a refundable tax credit in prepaid and other current assets for its (i) 2010 New York State QETC credit, totaling $248,486 and (ii) its New York City Biotechnology Tax Credit for the tax year of 2011 totaling $118,437.  On April 25, 2012, Synergy received $246,402 for its 2010 New York State QETC credit. In addition Callisto recorded a $225,000 New York State investment tax expense during the quarter ended June 30, 2012 related to tax years 2008 through 2011.

 

8. Net Loss per Share

 

Basic and diluted net loss per share is presented in conformity with ASC Topic 260, “Earnings per Share,” for all periods presented. In accordance with ASC Topic 260, basic and diluted net loss per common share was determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period. Diluted weighted-average shares are the same as basic weighted-average shares since the inclusion of issuable shares pursuant to the exercise of stock options and warrants, and the conversion of preferred stock would have been antidilutive.

 

The following table sets forth the potentially dilutive effect of all outstanding equity instruments which were not included in the computation of diluted earnings per share because they would be antidilutive:

 

 

 

June 30, 2012

 

June 30, 2011

 

 

 

 

 

 

 

Common Shares outstanding

 

158,516,071

 

158,516,071

 

Potentially dilutive common shares issuable upon:

 

 

 

 

 

Exercise of warrants

 

988,741

 

9,290,248

 

Exercise of Callisto stock options

 

5,756,237

 

7,435,371

 

Conversion of Series A Convertible Preferred Stock

 

222,222

 

222,222

 

 

 

 

 

 

 

Total fully diluted

 

165,483,271

 

175,463,912

 

 

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Table of Contents

 

9. Derivative Financial Instruments

 

Effective January 1, 2009, the Company adopted provisions of ASC Topic 815-40, “Derivatives and Hedging: Contracts in Entity’s Own Equity” (“ASC Topic 815-40”). ASC Topic 815-40 clarifies the determination of whether an instrument issued by an entity (or an embedded feature in the instrument) is indexed to an entity’s own stock, which would qualify as a scope exception under ASC Topic 815-10.

 

Synergy Derivative Financial Instruments

 

Effective January 1, 2009, the Company adopted provisions of ASC Topic 815-40, “Derivatives and Hedging: Contracts in Entity’s Own Equity” (“ASC Topic 815-40”). ASC Topic 815-40 clarifies the determination of whether an instrument issued by an entity (or an embedded feature in the instrument) is indexed to an entity’s own stock, which would qualify as a scope exception under ASC Topic 815-10.

 

Based upon the Company’s analysis of the criteria contained in ASC Topic 815-40, Synergy has determined that certain warrants issued in connection with sale of its common stock must be classified as derivative instruments. In accordance with ASC Topic 815-40, these warrants are also being re-measured at each balance sheet date based on estimated fair value, and any resultant changes in fair value is being recorded in the Company’s statement of operations. The Company estimates the fair value of certain warrants using the Black-Scholes option pricing model in order to determine the associated derivative instrument liability and change in fair value described above. The range of assumptions used to determine the fair value of the warrants at each period end during the periods indicated below were:

 

 

 

January 1, 2012 to
May 9, 2012 (1)

 

Six Months Ended
June 30, 2011

 

Estimated fair value of Synergy common stock

 

$4.05-$4.75

 

2.56-3.30

 

Expected warrant term

 

2.4-5.7 years

 

5-7 years

 

Risk-free interest rate

 

0.32%-1.33%

 

1.18%-2.5

%

Expected volatility

 

60%

 

90

%

Dividend yield

 

 

 

 


(1)         Synergy’s assets and liabilities have been deconsolidated as of May 9, 2012 and as a result there was no derivative instrument liability on the balance sheet as of June 30 2012. Changes in fair values of Synergy derivative instruments have been recorded through May 9, 2012. (See Note 5 above).

 

Estimated fair value of stock is the closing market price of the Company’s common stock on the date of warrant issuance and at the end of each reporting period when the derivative instruments are marked to market. Expected volatility is based on historical volatility of Synergy’s common stock. The warrants have a transferability provision and based on guidance provided in SAB 107 for instruments issued with such a provision, Synergy used the full contractual term as the expected term of the warrants. The risk free rate is based on the U.S. Treasury security rates for maturities consistent with the expected remaining term of the warrants and the date of grant or quarterly revaluation.

 

Certain of Synergy’s warrants issued during the six months ended June 30, 2011 contained a price protection clause which variable term required the Company to use a binomial model to determine fair value. There were no such price protected warrants issued during the six months ended June 30, 2012. The range of assumptions used to determine the fair value of the warrants was as follows:

 

 

 

Jan 1 to
 May 9, 2012

 

Six months ended,
June 30, 2011

 

Estimated fair value of stock

 

$3.28 - $4.50

 

$

1.89

 

 

 

 

 

 

 

Expected warrant term

 

4.4 — 4.6 years

 

7 years

 

Risk-free interest rate

 

0.72% - 1.03%

 

2.64%

 

Expected volatility

 

60%

 

90%

 

Dividend yield

 

 

 

 

In the Binomial model, the assumption for estimated fair value of the stock is based on a Black-Scholes based apportionment of the unit price paid for the shares and warrants issued in Synergy’s most recent registered direct offerings, which resulting stock prices were deemed to be arms-length negotiated prices. Expected volatility is based on historical volatility of Synergy’s common stock. The warrants have a transferability provision and based on guidance provided in SAB 107 for instruments issued with such a provision, Synergy used the full

 

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Table of Contents

 

contractual term as the expected term of the warrants. The risk free rate is based on the U.S. Treasury security rates for maturities consistent with the expected remaining term of the warrants.

 

The following table sets forth the components of changes in the Synergy’s derivative financial instruments liability balance for the periods indicated:

 

Date

 

Description

 

Warrants

 

Derivative
Instrument
Liability

 

12/31/2010

 

Balance of derivative financial instruments liability

 

728,469

 

$

3,487,959

 

3/31/2011

 

Fair value of new warrants issued during the quarter

 

210,000

 

$

1,312,673

 

3/31/2011

 

Change in fair value of warrants during the quarter recognized as other expense in the statement of operations

 

 

$

338,715

 

3/31/2011

 

Balance of derivative financial instruments liability

 

938,469

 

$

5,139,347

 

6/30/2011

 

Fair value of new warrants issued during the quarter

 

611,207

 

$

2,607,827

 

6/30/2011

 

Exercise of warrants during the quarter

 

(80,000

)

$

(486,328

)

6/30/2011

 

Change in fair value of warrants during the quarter recognized as other expense in the statement of operations

 

 

$

697,660

 

6/30/2011

 

Balance of derivative financial instruments liability

 

1,469,676

 

$

7,958,506

 

9/30/2011

 

Fair value of new warrants issued during the quarter

 

40,458

 

$

285,128

 

9/30/2011

 

Change in fair value of warrants during the quarter recognized as other income in the statement of operations

 

 

$

(4,382,796

)

9/30/2011

 

Balance of derivative financial instruments liability

 

1,510,134

 

$

3,860,838

 

12/31/2011

 

Fair value of new warrants issued during the quarter

 

1,810,294

 

$

3,082,203

 

12/31/2011

 

Reclass of derivative liability to equity during the quarter

 

(1,055,268

)

$

(1,707,317

)

12/31/2011

 

Change in fair value of warrants during the quarter recognized as other income in the statement of operations

 

 

$

(1,910,610

)

12/31/2011

 

Balance of derivative financial instruments liability

 

2,265,160

 

$

3,325,114

 

3/31/2012

 

Change in fair value of warrants during the quarter recognized as other income in the statement of operations

 

 

(7,946

)

3/31/2012

 

Balance of derivative financial instruments liability

 

2,265,160

 

3,317,168

 

 

 

 

 

 

 

 

 

6/30/2012

 

Change in fair value of warrants during the quarter recognized as other income in the statement of operations

 

 

439,116

 

6/30/2012

 

Reclass due to deconsolidation

 

(2,265,160

)

(3,756,284

)

 

 

 

 

 

 

 

 

6/30/2012

 

Balance of derivative financial instruments liability

 

 

 

 

Synergy Fair Value Measurements

 

The following table presents the Company’s liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of December 31, 2011 and June 30, 2012:

 

Description

 

Quoted Prices
in
Active
Markets
for Identical
Assets and
Liabilities
(Level 1)

 

Significant
Other
Observable
Inputs
(Level 2)

 

Significant
Unobservable
Inputs
(Level 3)

 

Balance as of
December 31,
2011

 

Quoted Prices
in
Active
Markets
for Identical
Assets and
Liabilities
(Level 1)

 

Significant
Other
Observable
Inputs
(Level 2)

 

Significant
Unobservable
Inputs
(Level 3)

 

Balance as of
June 30,
2012

 

Derivative liabilities related to Warrants

 

$

 

$

 

$

3,325,114

 

$

3,325,114

 

$

 

$

 

$

 

 

$

*

 

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The following table sets forth a summary of changes in the fair value of the Company’s Level 3 liabilities for the six months ended June 30, 2012:

 

Description

 

Balance at
December 31,
2011

 

Fair Value of
warrants upon
issuance

 

Unrealized
(gains) or
losses

 

Balance as of
June 30,
2012

 

Derivative liabilities related to Warrants

 

$

3,325,114

 

$

 

$

()

 

$

*

 


(*) Synergy’s assets and liabilities have been deconsolidated as of May 9, 2012 and as a result there was no derivative instrument liability on the balance sheet as of June 30 2012. Changes in fair values of Synergy derivative instruments have been recorded through May 9, 2012. (See Note 5 above).

 

The unrealized gains or losses on the derivative liabilities are recorded as a change in fair value of derivative liabilities in the Company’s statement of operations. 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. At each reporting period, the Company reviews the assets and liabilities that are subject to ASC Topic 815-40. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3.

 

10. Stockholder’s Equity

 

On October 20, 2010 Callisto entered into an option agreement (the “Agreement”) with a third party (“Optionee”) granting the Optionee the right to purchase up to 2,000,000 shares of the common stock of Synergy Pharmaceuticals, Inc., currently owned by Callisto (the “Shares”) at a purchase price of $2.45 per share. On June 3, 2011, the Optionee paid Callisto $100,000 in cash for this option which may be exercised at any time during the period from the date of the Agreement until (i) October 20, 2012 with respect to 1,000,000 Shares and (ii) October 20, 2015 with respect to 1,000,000 Shares. On April 25, 2012, Callisto amended the Agreement (the “Amended Agreement) to reflect Synergy’s (1:2) reverse stock split and also simplified the option term.  This Amended Agreement granted the Optionee the right to purchase up to 1,000,000 shares of the common stock of Synergy Pharmaceuticals, Inc. currently owned by Callisto, at a purchase price of $4.90 per share, at any time during the period from April 25, 2012 until April 20, 2014.

 

On January 30, 2012 Synergy issued 26,250 unregistered shares of common stock to its corporate counsel for professional services rendered. The shares had a fair value on the date of issuance of $3.53 per share and $92,663 was recorded as legal expense during the quarter ended March 31, 2012.

 

11. Subsequent Events

 

On July 20, 2012, Synergy entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Callisto. Pursuant to the Merger Agreement, following the satisfaction or waiver of each of the applicable conditions set forth in the Merger Agreement, Callisto and Synergy will merge (the “Merger”), whereupon Callisto’s separate corporate existence will cease and Synergy will continue as the surviving corporation of the Merger.

 

As a result of the Merger, each outstanding share of Callisto common stock will be converted into the right to receive 0.17 of one share of Synergy common stock (the “Exchange Ratio”) as set forth in the Merger Agreement and the 22,295,000 shares of Synergy held by Callisto will be canceled. Under the terms of the Merger Agreement at closing, Synergy will issue, and Callisto stockholders will receive in a tax-free exchange, shares of Synergy common stock such that Callisto stockholders will own approximately 38.3 percent of the combined company on a pro forma basis and Synergy stockholders will own approximately 61.7

 

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percent. Each share of Synergy Common Stock received in connection with the Merger shall be subject to a lock-up beginning on the effective date of the Merger and ending on the earlier of (i) eighteen (18) months after such date or (ii) a Change in Control (as defined in the Merger Agreement).

 

The consummation of the Merger is subject to various customary closing conditions, including but not limited to, (i) approval by Callisto’s and Synergy’s stockholders, (ii) the Registration Statement on Form S-4 shall have been declared effective by the SEC and (iii) the shares of Synergy common stock to be issued in the Merger shall have been approved for listing on The NASDAQ Capital Market. Upon consummation of the Merger the related party balances due from Callisto, $1,936,609 as of June 30, 2012, (See Note 11) will be eliminated in consolidation.

 

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ITEM 2.   MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion should be read in conjunction with our condensed consolidated financial statements and other financial information appearing elsewhere in this quarterly report. In addition to historical information, the following discussion and other parts of this quarterly report contain forward-looking statements. You can identify these statements by forward-looking words such as “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words. Forward-looking statements include information concerning possible or assumed future business success or financial results. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. We believe that it is important to communicate future expectations to investors. However, there may be events in the future that we are not able to accurately predict or control. Accordingly, we do not undertake any obligation to update any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.

 

The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties set forth under “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2011 and other periodic reports filed with the SEC. Accordingly, to the extent that this Report contains forward-looking statements regarding the financial condition, operating results, business prospects or any other aspect of the Company, please be advised that Callisto’s actual financial condition, operating results and business performance may differ materially from that projected or estimated by the Company in forward-looking statements. All drug candidates to treat GI disorders and diseases, currently plecanatide and SP-333, are being developed exclusively by Synergy Pharmaceuticals, Inc., (“Synergy”). Use of the terms “we”, “our” or “us” in connection with GI drug candidates discussed herein refer to research and development activities and plans of Synergy.

 

BUSINESS OVERVIEW

 

We are a development stage biopharmaceutical company focused primarily on the development of drugs to treat gastrointestinal (“GI”) disorders and diseases and was incorporated under the laws of the State of Delaware on June 5, 1996 (inception). Since inception, our efforts have been principally devoted to research and development, securing and protecting patents and raising capital.

 

On May 9, 2012, our controlled subsidiary, Synergy Pharmaceuticals, Inc. (“Synergy”) closed an underwritten public offering of 10 million shares of common stock at an offering price of $4.50 per share, resulting in gross proceeds of $45 million before deducting underwriting discounts, commissions and other estimated offering expenses of approximately $3 million. As a result our equity ownership decreased to approximately 34% of Synergy and we determined that we no longer had control over the operations and decision making of Synergy. Therefore, we deconsolidated Synergy and derecognized the Synergy assets, liabilities, and non-controlling interest from our financial statements. For the quarter ended June 30, 2012, the gain attributed to the deconsolidation was $120,393,000. As of the date of deconsolidation, May 9, 2012, we began accounting for our investment in Synergy under the equity method and accordingly recognized our share of Synergy losses in the amount of $2,390,000 for the period from May 9, 2012 through June 30, 2012. As of June 30, 2012, our investment in Synergy was $117,814,450.

 

Critical Accounting Policies

 

Investment in Synergy

 

We account for our investment in Synergy under the equity method of accounting as we do not have the elements of control that would require consolidation. The investment is subsequently adjusted for equity in net income.

 

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RECENT DEVELOPMENTS

 

FINANCIAL OPERATIONS OVERVIEW

 

From inception through June 30, 2012, we have sustained cumulative net losses attributable to common stockholders of $28,597,758. Our losses have resulted primarily from expenditures incurred in connection with research and development activities related to the application and filing for regulatory approval of proposed products, stock-based compensation expense, patent filing and maintenance expenses, purchase of in-process research and development, outside accounting and legal services and regulatory, scientific and financial consulting fees, as well as deemed dividends attributable to the beneficial conversion rights of convertible preferred stock at issuance. From inception through June 30, 2012, we have not generated any revenue from operations, expect to incur additional losses to perform further research and development activities and do not currently have any commercial biopharmaceutical products, and do not expect to have such for several years, if at all.

 

Net cash used in operating activities was $13,244,841 during the six months ended June 30, 2012 as compared to $6,745,143 for the six months ended June 30, 2011 and $104,732,339 during the period from June 5, 1996 (inception) to June 30, 2012. During the three months and six months ended June 30, 2012 we earned net income attributable to common stockholders of $116,910,814, $113,768,555, and a net loss of $28,597,758 during the period from June 5, 1996 (inception) to June 30, 2012, respectively, which included gain upon deconsolidation of Synergy at amount of $120,393,000 and loss from equity method investment in Synergy of $2,390,000 on May 9, 2012.

 

Net losses attributable to common shareholders for the three months and six months ended June 30, 2011 were $2,500,596 and $4,261,963, respectively. To date, our sources of cash have been primarily limited to the sale of equity securities and issuance of debt instruments. Net cash provided by financing activities for the six months ended June 30, 2011 and for the period from June 5, 1996 (inception) to June 30, 2012, was $5,634,265, and $104,822,742 respectively.  There were no financing activities during the six months ended June 30, 2012.

 

On July 20, 2012, Callisto’s former controlled subsidiary, Synergy Pharmaceuticals, Inc. (Synergy”) entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Callisto. Pursuant to the Merger Agreement, following the satisfaction or waiver of each of the applicable conditions set forth in the Merger Agreement, Callisto and Synergy will merge (the “Merger”), whereupon Callisto’s separate corporate existence will cease and Synergy will continue as the surviving corporation of the Merger. Please see footnote 11for further discussions.

 

OFF-BALANCE SHEET ARRANGEMENTS

 

We had no off-balance sheet arrangements as of June 30, 2012.

 

RESULTS OF OPERATIONS

 

THREE MONTHS ENDED June 30, 2012 AND June 30, 2011

 

We had no revenues during the three months ended June 30, 2012 and 2011 because we do not have any commercial biopharmaceutical products and we do not expect to have such products for several years, if at all.

 

Research and development expenses for the three months ended June 30, 2012 increased $185,990 or 7.9%, to $2,542,089 from $2,356,099 for the three months ended June 30, 2011. The $2,542,089 during the three months this year represented approximately one month of Synergy’s research and development expenses as a result of the deconsolidation, while $ 2,356,099 during the three months last year represented three months of Synergy’s expenses. This increase of $185,990 was primary due to Synergy’s largely increased development cost prior to deconsolidation.

 

General and administrative expenses decreased $1,070,495 or 57%, to $805,193 for the three months ended June 30, 2012 from $1,875,688 for the three months ended June 30, 2011. $805,193 during the three months this year represented approximately one month of Synergy’s general and administrative expenses, while $1,875,688 during the three months last year represented three months of Synergy’s expenses.  The difference of $1,070,495 represented approximately two thirds of Synergy’s three month of expense, not included as a result of the deconsolidation.

 

Net income attributable to common stockholders for the three months ended June 30, 2012 increased $119,411,410 to $116,910,814 compared to a net loss of $2,500,596 incurred for the three months ended June 30, 2012. The increase is primary the $120,393,000 gain

 

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recognized on the deconsolidation of Synergy, net of $ 2,390,000 loss recognized in our investment in Synergy using the equity method. We did not have a similar transaction in the quarter ended June 30, 2012.

 

SIX MONTHS ENDED JUNE 30, 2012 AND JUNE 30, 2011

 

We had no revenues during the six months ended June 30, 2012 and 2011 because we do not have any commercial biopharmaceutical products and we do not expect to have such products for several years, if at all.

 

Research and development expenses for the six months ended June 30, 2012 increased $4,152,202 or 111%, to $7,880,229 from $3,728,027 for the six months ended June 30, 2011. The $7,880,229 during the six months this year represented approximately four months of Synergy’s research and development expenses as a result of the deconsolidation, while $3,728,027 during the six months last year represented six months of Synergy’s expenses. This increase of $4,152,202 was primary due to Synergy’s largely increased development cost prior to deconsolidation.

 

General and administrative expenses decreased $1,077,030 or 28%, to $2,758,502 for the six months ended June 30, 2012 from $3,835,532 for the six months ended June 30, 2011. $2,758,503 during the six months this year represented approximately four month of Synergy’s general and administrative expenses, while $3,835,532 during the six months last year represented six months of Synergy’s expenses.  The difference of $1,077,029 represented approximately one third of Synergy’s six months of expense, not included as a result of the deconsolidation.

 

Net gain attributable to common stockholders for the three months ended June 30, 2012 increased $118,030,518 to $113,768,555, compared to a net loss of $4,263,963 incurred for the six months ended June 30, 2012. The increase is primary the $ 120,393,000 gain recognized on the deconsolidation of Synergy, net of $ 2,390,000 loss recognized in our investment in Synergy using the equity method. We did not have a similar transaction during the six months ended June 30, 2012.

 

LIQUIDITY AND CAPITAL RESOURCES

 

We had $ 120 in cash and cash equivalents as of June 30, 2012, compared to $13,244,961 as of December 31, 2011. On May 9, 2012, Synergy closed an underwritten public offering of 10 million shares of common stock at an offering price of $4.50 per share, resulting in gross proceeds of $45 million before deducting underwriting discounts, commissions and other estimated. As a result our equity ownership decreased to approximately 34% of Synergy and we determined that we no longer had control over the operations and decision making of Synergy. Therefore, we deconsolidated Synergy and derecognized the Synergy assets, liabilities, and non-controlling interest from our financial statements as of that date.

 

Our condensed consolidated financial statements as of June 30, 2012 and December 31, 2011 have been prepared under the assumption that we will continue as a going concern for the next twelve months. Our ability to continue as a going concern is dependent upon our ability to obtain additional equity or debt financing, attain further operating efficiencies and, ultimately, to generate revenue. The financial statements do not include any adjustments that might result from the negative outcome of this uncertainty.

 

CRITICAL ACCOUNTING POLICIES

 

Financial Reporting Release No. 60 requires all companies to include a discussion of critical accounting policies or methods used in the preparation of financial statements. Our accounting policies are described in ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA of our Annual Report on Form 10-K as of and for year ended December 31, 2011, filed with the SEC on March 30, 2012. There have been no changes to our critical accounting policies since December 31, 2011.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our exposure to market risk on the fair values of certain assets is related to credit risk associated with securities held in short term investment accounts, commercial paper included in short term money market accounts and the FDIC insurance limit on our bank balances. At June 30, 2012 we don’t have balances in money market balances.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Based on an evaluation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended) required by paragraph (b) of Rule 13a-15 or Rule 15d-15, as of June 30, 2012, our Chief Executive Officer and Principal Financial Officer have concluded that as of June 30, 2012, our disclosure controls and procedures were not effective in ensuring

 

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that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms.

 

In connection with the preparation of our annual financial statements, our management performed an assessment of the effectiveness of internal control over financial reporting as of December 31, 2011. Management’s assessment included an evaluation of the design of our internal control over financial reporting and the operational effectiveness of those controls. Based on this evaluation, management determined that, as of December 31, 2011, there were material weaknesses in our internal control over financial reporting. The material weaknesses identified during management’s assessment were (i) an effective whistle-blower program or other comparable mechanism and (ii) an ongoing program to manage identified fraud risks. As of December 31, 2011, we did not maintain effective internal control over financial reporting. As defined by Regulation S-X, Rule 1-02(a)(4), a material weakness is a deficiency or a combination of deficiencies, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected.

 

In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily is required to apply its judgment in evaluating the relationship between the benefit of desired controls and procedures and the cost of implementing new controls and procedures.

 

CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING

 

As of June 30, 2012, we are in the process of remediating the material weakness which existed at December 31, 2011. If these remedial measures are insufficient to address any of the identified material weaknesses or are not implemented effectively, or additional deficiencies arise in the future, material misstatements in our interim or annual financial statements may occur in the future.

 

There were no changes in our internal controls over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that could significantly affect internal controls over financial reporting during the quarter ended June 30, 2012.

 

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Table of Contents

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

There have been no material changes from the legal proceedings disclosed in our Form 10-K for the year ended December 31, 2011.

 

ITEM 1A. RISK FACTORS

 

There have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, 2011.

 

ITEM 6 EXHIBITS

 

(a)

 

 

Exhibits

 

 

 

31.1

Certification of Chief Executive Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.

 

 

31.2

Certification of Principal Financial Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.

 

 

32.1

Certification of Chief Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

32.2

Certification of Principal Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

101

Financial statements from the quarterly report on Form 10-Q of the Company for the quarter ended June 30, 2012, filed on August 20, 2012, formatted in Extensible Business Reporting Language (XBRL): (i) the Condensed Consolidated Statements of Operations, (ii) the Condensed Consolidated Balance Sheets, (iii) the Condensed Consolidated Statements of Cash Flows (iv) the Condensed Consolidated Statement of Stockholders Equity (Deficit) and (v) the Notes to Consolidated Financial Statements tagged as blocks of text.

 

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SIGNATURES

 

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

 

 

CALLISTO PHARMACEUTICALS, INC.

 

(Registrant)

 

 

 

Date: August 20, 2012

By:

/s/ GARY S. JACOB

 

 

 

 

 

Gary S. Jacob

 

 

Chief Executive Officer

 

 

 

Date: August 20, 2012

By:

/s/ BERNARD F. DENOYER

 

 

 

 

 

Bernard F. Denoyer

 

 

Senior Vice President, Finance

 

31