Item 1.
|
FINANCIAL STATEMENTS
|
POINT THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
September 30,
2007
|
|
|
December 31,
2006
|
|
Assets
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
2,310,642
|
|
|
$
|
9,797,930
|
|
Cash and cash equivalentsrestricted
|
|
|
|
|
|
|
300,000
|
|
Unbilled receivable
|
|
|
|
|
|
|
2,904
|
|
Prepaid expenses and other current assets
|
|
|
810,251
|
|
|
|
2,228,555
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
3,120,893
|
|
|
|
12,329,389
|
|
Office and laboratory equipment, net
|
|
|
30,394
|
|
|
|
238,395
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
3,151,287
|
|
|
$
|
12,567,784
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders equity
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
97,450
|
|
|
$
|
2,170,491
|
|
Accrued severance
|
|
|
1,240,000
|
|
|
|
|
|
Accrued clinical trial costs & drug development
|
|
|
36,000
|
|
|
|
1,574,222
|
|
Accrued expenses
|
|
|
203,873
|
|
|
|
830,400
|
|
Short-term portion of capital lease
|
|
|
|
|
|
|
4,723
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
1,577,323
|
|
|
|
4,579,836
|
|
Patent liability, less current portion
|
|
|
30,261
|
|
|
|
36,601
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Preferred stock, $0.01 par value, 1,000,000 shares authorized; no shares issued or outstanding
|
|
|
|
|
|
|
|
|
Common stock, $0.01 par value; 75,000,000 shares authorized; 39,530,130 shares and 33,001,354 shares issued at September 30, 2007
and December 31, 2006, respectively, 39,311,585 shares and 32,782,809 shares outstanding at September 30, 2007 and December 31, 2006, respectively
|
|
|
395,302
|
|
|
|
330,014
|
|
Treasury stock, 218,545 shares outstanding at September 30, 2007 and December 31, 2006, at cost
|
|
|
(978,290
|
)
|
|
|
(978,290
|
)
|
Additional paid-in capital
|
|
|
104,831,722
|
|
|
|
100,333,199
|
|
Deficit accumulated during the development stage
|
|
|
(102,705,031
|
)
|
|
|
(91,733,576
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
1,543,703
|
|
|
|
7,951,347
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
3,151,287
|
|
|
$
|
12,567,784
|
|
|
|
|
|
|
|
|
|
|
3
POINT THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
September 30,
|
|
|
Nine months ended
September 30,
|
|
|
Period from
September 3, 1996
(date of inception)
through September 30,
2007
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License revenue
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
5,115,041
|
|
Sponsored research revenue
|
|
|
|
|
|
|
220,407
|
|
|
|
|
|
|
|
359,202
|
|
|
|
3,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
|
220,407
|
|
|
|
|
|
|
|
359,202
|
|
|
|
8,115,041
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
374,604
|
|
|
|
6,730,726
|
|
|
|
5,823,537
|
|
|
|
18,984,026
|
|
|
|
80,323,877
|
|
General and administrative
|
|
|
2,071,699
|
|
|
|
1,555,968
|
|
|
|
5,390,538
|
|
|
|
5,286,920
|
|
|
|
33,454,300
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
2,446,303
|
|
|
|
8,286,694
|
|
|
|
11,214,075
|
|
|
|
24,270,946
|
|
|
|
113,778,177
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from operations
|
|
|
(2,446,303
|
)
|
|
|
(8,066,287
|
)
|
|
|
(11,214,075
|
)
|
|
|
(23,911,744
|
)
|
|
|
(105,663,136
|
)
|
Other income and expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
36,262
|
|
|
|
240,724
|
|
|
|
242,620
|
|
|
|
883,624
|
|
|
|
3,040,757
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(82,652
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income, net
|
|
|
36,262
|
|
|
|
240,724
|
|
|
|
242,620
|
|
|
|
883,624
|
|
|
|
2,958,105
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(2,410,041
|
)
|
|
$
|
(7,825,563
|
)
|
|
$
|
(10,971,455
|
)
|
|
$
|
(23,028,120
|
)
|
|
$
|
(102,705,031
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.06
|
)
|
|
$
|
(0.24
|
)
|
|
$
|
(0.29
|
)
|
|
$
|
(0.70
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net loss per common share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
39,311,585
|
|
|
|
32,764,059
|
|
|
|
38,426,842
|
|
|
|
32,760,862
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
4
POINT THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended
September 30,
|
|
|
Period
from
inception
(September 3,
1996) through
September 30,
2007
|
|
|
|
2007
|
|
|
2006
|
|
|
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(10,971,455
|
)
|
|
$
|
(23,028,120
|
)
|
|
$
|
(102,705,031
|
)
|
Adjustments to reconcile net loss to net cash used:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
76,030
|
|
|
|
101,046
|
|
|
|
656,307
|
|
Impairment of fixed assets
|
|
|
123,471
|
|
|
|
1,205
|
|
|
|
124,114
|
|
Stock-based compensation
|
|
|
168,980
|
|
|
|
1,612,649
|
|
|
|
3,223,947
|
|
Common stock issued under license agreement
|
|
|
|
|
|
|
|
|
|
|
910,677
|
|
Accrued interest on convertible notes
|
|
|
|
|
|
|
|
|
|
|
82,652
|
|
Patent costs
|
|
|
|
|
|
|
|
|
|
|
75,557
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted cash
|
|
|
300,000
|
|
|
|
5,834
|
|
|
|
|
|
Unbilled accounts receivable
|
|
|
2,904
|
|
|
|
(59,202
|
)
|
|
|
|
|
Prepaid expenses and other assets
|
|
|
1,418,304
|
|
|
|
176,897
|
|
|
|
(829,528
|
)
|
Accounts payable and accrued expenses
|
|
|
(2,977,790
|
)
|
|
|
(1,111,553
|
)
|
|
|
1,574,879
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(11,879,556
|
)
|
|
|
(22,301,244
|
)
|
|
|
(96,886,426
|
)
|
|
|
|
|
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of office and laboratory equipment
|
|
|
|
|
|
|
(41,395
|
)
|
|
|
(874,420
|
)
|
Proceeds from disposal of property and equipment
|
|
|
8,500
|
|
|
|
7,100
|
|
|
|
63,605
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
8,500
|
|
|
|
(34,295
|
)
|
|
|
(810,815
|
)
|
|
|
|
|
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net
|
|
|
4,390,831
|
|
|
|
|
|
|
|
78,040,886
|
|
Proceeds from merger between Point and HMSR Inc.
|
|
|
|
|
|
|
|
|
|
|
14,335,285
|
|
Dividend from HemaSure A/S
|
|
|
|
|
|
|
787,150
|
|
|
|
787,150
|
|
Proceeds from issuance of convertible note
|
|
|
|
|
|
|
|
|
|
|
1,892,904
|
|
Proceeds from warrant exercises
|
|
|
|
|
|
|
|
|
|
|
4,512,425
|
|
Proceeds from stock option exercises
|
|
|
4,000
|
|
|
|
8,800
|
|
|
|
482,085
|
|
Proceeds from capital lease financing
|
|
|
|
|
|
|
|
|
|
|
13,082
|
|
Payments on capital leases
|
|
|
(4,723
|
)
|
|
|
(4,723
|
)
|
|
|
(13,082
|
)
|
Principal payments of patent liability
|
|
|
(6,340
|
)
|
|
|
(5,763
|
)
|
|
|
(42,852
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
4,383,768
|
|
|
|
785,464
|
|
|
|
100,007,883
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(7,487,288
|
)
|
|
|
(21,550,075
|
)
|
|
|
2,310,642
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, beginning of period
|
|
|
9,797,930
|
|
|
|
37,328,396
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
|
$
|
2,310,642
|
|
|
$
|
15,778,321
|
|
|
$
|
2,310,642
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
5
POINT THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2007
(UNAUDITED)
1.
|
Nature of the Business
|
Point Therapeutics, Inc.
(Point or the Company) is a biopharmaceutical company which has studied its lead product candidate, talabostat, in a number of human clinical trials in late-stage cancers. In May 2007, interim clinical results caused the
Companys Independent Data Monitoring Committee to recommend stopping the Companys two Phase 3 talabostat studies for patients in advanced non-small cell lung cancer. Subsequently, the talabostat clinical development program was put on
clinical hold by the U.S. Food and Drug Administration (FDA). The Company has also studied talabostat in several Phase 2 trials, including as a single-agent and in combination with cisplatin in metastatic melanoma, in combination with
rituximab in advanced chronic lymphocytic leukemia, and in combination with gemcitabine in Stage IV pancreatic cancer. Due to cash limitations, the Company is not currently funding any research or clinical operations.
On October 9, 2007, the Company entered into a definitive agreement to merge with DARA BioSciences, Inc. (DARA) pursuant to which DARA
will merge with DP Acquisition Corp., a newly-formed subsidiary of the Company, with DARA surviving as a wholly-owned subsidiary. After giving effect to the merger, DARA stockholders will hold 96.4% of the Companys outstanding shares of common
stock on a fully-diluted basis, and the Company will change its name to DARA BioSciences, Inc. and be based in Raleigh, North Carolina (see Note 9 below).
The accompanying consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
However, as shown in the September 30, 2007 financial statements, the Company has cash of $2,311,000 and an accumulated deficit of $102,705,000. The Company also incurred a net loss of $10,971,000 and negative cash flows from operations of
$11,880,000 during the first nine months of 2007 and has also incurred a net loss and negative cash flows from operations in each of the last five years. As a result, there exists substantial doubt about the Companys ability to continue as a
going concern without additional financing. To date, the Company has principally raised capital through public and private placements of its equity securities. The Company has recently terminated all but two employees (the former senior executives
of the Company have retained their corporate titles and are currently acting as consultants to Point as part of a more variable-cost consulting team), ceased funding its research and clinical operations and has entered into an agreement to merge
with DARA. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities, or any other adjustments that might be
necessary should the Company be unable to continue as a going concern.
2.
|
Significant Accounting Policies
|
Unaudited Interim Financial
Statements
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally
accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting
principles for the complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three month period
ended September 30, 2007 are not indicative of the results that may be expected for the year ended December 31, 2007.
The
condensed consolidated balance sheet at December 31, 2006 has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting
principles for complete financial statements.
For further information, refer to the consolidated financial statements and footnotes
thereto included in the Companys annual report on Form 10-K for the year ended December 31, 2006.
6
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements
and accompanying notes. Actual results could differ from those estimates.
Net Loss Per Common Share
Basic and diluted net loss per common share amounts are presented in conformity with Statement of Financial Accounting Standards (SFAS)
No. 128, Earnings per Share, for all periods presented. In accordance with SFAS No. 128, basic and diluted net loss per common share amounts have been computed using the weighted-average number of shares of common stock
outstanding for the three and nine month periods ended September 30, 2007 and 2006. Potentially dilutive securities, consisting of stock options of 2,681,922 and warrants of 3,962,492 outstanding at September 30, 2007 and stock options of
5,314,728 and warrants of 2,592,500 outstanding at September 30, 2006 have been excluded from the diluted earnings per share calculations since their effect is antidilutive.
Stock-Based Compensation
The Company follows the provisions of SFAS 123(R),
Share-Based
PaymentAn Amendment of FASB Statement No. 123
(SFAS No. 123R) which requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on
their fair value over the requisite service period. Pro forma disclosure is no longer an alternative. In March 2005, the SEC issued Staff Accounting Bulletin (SAB) No. 107 (SAB No. 107), which expressed
the views of the SEC regarding the interaction between SFAS No. 123R and certain rules and regulations of the SEC. SAB No. 107 provides guidance related to the valuation of share-based payment arrangements for public companies,
including assumptions such as expected volatility and expected term.
Prior to January 1, 2006, the Company applied the pro forma
disclosure requirements under SFAS No. 123 and accounted for its stock-based employee compensation plans using the intrinsic value method under the recognition and measurement provisions of Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees
and related interpretations.
Accordingly, no stock-based employee compensation cost was
recognized in the statement of operations for the years prior to January 1, 2006, as all stock options granted under the Companys stock option plans had an exercise price equal to the market value of the underlying common stock on the
date of grant.
For the three month period ended September 30, 2007, the Company recorded a credit of non-cash stock-based
compensation expense in accordance with SFAS No. 123R of $203,000 for stock options granted to employees and outside directors under the Companys stock option plans, of which $56,000 was included in research and development expenses and
$146,000 was included in general and administrative expenses. The credit recorded resulted from an adjustment in the forfeiture rate previously estimated as all but two of our employees were terminated as of September 30, 2007. For the nine month
period ended September 30, 2007, the Company recorded non-cash stock-based compensation expense of $169,000 for stock options granted under the Companys stock option plans, of which a credit in the amount of $186,000 was recorded in
research and development expenses and a credit of $355,000 was recorded in general and administrative expenses.
For the three-month period
ended September 30, 2006, the Company recorded non-cash stock-based compensation expense of $488,000 for stock options granted under the Companys stock option plans, of which $262,000 was included in research and development expenses and
$226,000 was included in general and administrative expenses. For the nine-month period ended September 30, 2006, the Company recorded non-cash stock-based compensation expense of $1,613,000 for stock options granted under the Companys
stock option plans, of which $778,000 was recorded in research and development expenses and $835,000 was included in general and administrative expenses.
In connection with the work force reductions in 2007, the Company extended the time terminated employees had to vest their stock options from 90 days post termination to December 31, 2007. Utilizing the
Black-Scholes method, the Company determined that they did not have to record any incremental non-cash stock compensation as a result of this modification to the grants.
No amounts relating to stock-based compensation have been capitalized.
The Companys stock option
plans allow for the granting of incentive and nonqualified options and awards to purchase shares of the Companys common stock. Historically, incentive options granted to employees under the Companys stock option plans generally vested
over a four-year period, with 25% vesting on each anniversary date of the grant. Nonqualified options issued to non-employee directors and consultants under the Companys stock option plans generally vest during their period of service with the
Company. Options granted under the Companys stock option plans have a maximum term of ten
7
years from the date of grant. At September 30, 2007, a total of 7,876,085 shares of common stock were approved for issuance under the Companys
stock option plans and 5,712,542 shares underlying options were available for future grant under the Companys stock option plans.
The Company uses the Black-Scholes option pricing model to calculate the fair value on the grant date of stock-based compensation for stock options granted. The fair value of stock options granted during the nine month periods ended
September 30, 2007 and 2006 was calculated using the following estimated weighted-average assumptions:
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
Expected term (years)
|
|
4.0
|
|
|
4.0
|
|
Volatility
|
|
87
|
%
|
|
6593
|
%
|
Risk-free interest rate
|
|
4.8
|
%
|
|
4.35.1
|
%
|
Expected term
The expected term of options granted represents the period of time for
which the options are expected to be outstanding and is derived from the Companys stock option exercise experience and option expiration data. The Company believes that this is currently the best estimate of the expected term of a new
option. In addition, for purposes of estimating the expected term, the Company has aggregated all individual option awards into one group as the Company does not expect substantial differences in exercise behavior among its employees.
Expected volatility
The expected volatility is a measure of the amount by which the Companys stock price is expected to
fluctuate during the expected term of options granted. The Company determines the expected volatility based upon the historical volatility of the Companys common stock over a period commensurate with the options expected term, as
adjusted. The Company also reviewed the volatility of other similar stage companies in the biotechnology industry.
Risk-free
interest rate
The risk-free interest rate is the implied yield available on U.S. Treasury zero-coupon issues with a remaining term equal to the options expected term on the grant date.
Expected dividend yield
The Company has never declared or paid any cash dividends on any of its common stock and does not expect to do so in
the foreseeable future. Accordingly, the Company uses an expected dividend yield of zero to calculate the grant date fair value of a stock option.
The Company recognizes compensation expense on a straight-line basis over the requisite service period based upon options that are ultimately expected to vest, and accordingly, such compensation expense has been
adjusted by an amount of estimated forfeitures. Forfeitures represent only the unvested portion of a surrendered option. SFAS No. 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. Prior to the adoption of SFAS No. 123R, the Company accounted for forfeitures upon occurrence as permitted under SFAS No. 123. During the three and nine month period ended
September 30, 2007, the Company recorded forfeitures based upon actual forfeitures with an estimate for future forfeitures based on historical data which it believes is a reasonable assumption to estimate forfeitures. The rate used for the nine
month period ended September 30, 2007 was 100.0% due to the termination of all but two of our employees as of September 30, 2007, and the proposed merger with DARA. For the nine month period ended September 30, 2006, the Company accounted
for forfeitures based upon historical data only using a rate of 4.5% which at the time was a reasonable estimate of forfeitures. The estimation of forfeitures requires significant judgment, and to the extent actual results or updated estimates
differ from the Companys current estimates, such amounts will be recorded as a cumulative adjustment in the period estimates are revised.
The weighted-average per share fair value of stock options granted under the Companys stock option plans during the nine month period ended September 30, 2007 and 2006 was $0.46 and $1.88, respectively.
Information regarding option activity for the nine month period ended September 30, 2007 under the Companys stock option plans is summarized
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
Outstanding
|
|
|
Weighted-
Average
Exercise
Price Per
Share
|
|
Weighted-
Average
Remaining
Contractual
Term in
Years
|
|
Aggregate
Intrinsic
Value
|
Options outstanding at December 31, 2006
|
|
5,038,228
|
|
|
$
|
3.44
|
|
|
|
|
|
Granted
|
|
92,500
|
|
|
$
|
0.46
|
|
|
|
|
|
Exercised
|
|
(5,000
|
)
|
|
$
|
0.80
|
|
|
|
|
|
Forfeited
|
|
(1,521,791
|
)
|
|
$
|
3.59
|
|
|
|
|
|
Expired
|
|
(922,015
|
)
|
|
$
|
3.06
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at September 30, 2007
|
|
2,681,922
|
|
|
$
|
3.38
|
|
1.53
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options vested and exercisable at September 30, 2007
|
|
2,636,922
|
|
|
$
|
3.37
|
|
1.42
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
There is no aggregate intrinsic value in the table above which would represent the total pre-tax
intrinsic value (the difference between the closing price of the Companys common stock on September 30, 2007 of $0.04 and the exercise price of each in-the-money option) that would have been received by the option holders had all option
holders exercised their options on September 30, 2007 due to the fact that all current stock options are priced above $0.04 per share. Total cash received for stock options exercised during the nine month period ended September 30,
2007 was $4,000. Total intrinsic value of stock options exercised under the Companys stock option plans for the nine month period ended September 30, 2007 was $300.
As of September 30, 2007, there was $86,000 of total unrecognized compensation cost related to unvested share-based awards. That cost is
expected to be recognized over a period of 2.5 remaining years with a weighted-average of 2.03 years.
On February 2, 2007, the Company
priced a registered direct offering (the Offering) for the sale of 6,523,776 shares of its common stock at a price of $0.73 per share. The Offering closed on February 7, 2007 with gross proceeds from the Offering of $4,762,000.
After placement agent fees of $286,000 and other expenses related to the offering totaling $85,000, net proceeds to the Company were $4,391,000. The investors in this offering also received five-year warrants, exercisable upon expiration of a
lock-up period of six months, to purchase an additional 978,566 shares of common stock at an exercise price of $1.00 per share. The Company also issued 391,426 warrants at an exercise price of $1.00 per share to the placement agent,
Rodman & Renshaw LLC, exercisable upon expiration of a lock-up period of six months. The offered shares are registered pursuant to the Companys shelf registration statement that was declared effective by the Securities and Exchange
Commission (the SEC) on January 12, 2005.
As a result of this offering, 1,150,000 previously issued warrants were
repriced from $5.31 per share to $4.54 per share.
On March 2, 2007, the
Company received an insurance settlement in the amount of $305,000 relating to a shipment of drug supply that was damaged in June 2006 during shipping. The Company recorded this as a credit to manufacturing expense in the three month period ended
March 31, 2007.
In June 2007, the Company
reduced its work force from 33 employees to 8 employees. The total charge for this work force reduction for severance and related fringes was approximately $260,000. All severance was paid in a lump sum based on the Companys severance plan,
which permits employees to receive a base severance of two weeks plus one week for each year of service. In July 2007, the Company further reduced its workforce, including senior executives of the Company, to two employees. The total charge for this
workforce reduction for severance and related fringes was approximately $285,000. All severance was paid in a lump sum based on the Companys severance plan, which permits employees to receive a base severance of two weeks plus one week for
each full year of service. The Company also recorded $1,240,000 of additional severance benefits payable to certain former executives of the Company in accordance with their employment contracts. These severance benefits have not been paid to these
individuals as of September 30, 2007.
On July 26, 2007, the
Company reached an agreement with its landlord, KNH Realty Trust (KNH) to terminate the lease for its corporate offices at 155 Federal Street in Boston, Massachusetts (the Termination Agreement) effective July 31, 2007.
The Termination Agreement provides for a one time payment of approximately $333,000 by the Company to KNH in consideration of releasing the Company from all of its obligations under its lease, dated as of March 16, 2005, the term of which
otherwise ran until July 1, 2010. The one-time payment was made by the Company in the third quarter of 2007. In addition, the Company agreed to transfer ownership of all of its furniture, office equipment and leasehold improvements to KNH, all
of which were deemed to be impaired at June 30, 2007. On July 31, 2007, the Company relocated its corporate offices to a substantially smaller temporary location at 70 Walnut Street in Wellesley Hills, Massachusetts.
9
As a result of the workforce
reduction in 2007 and the subsequent negotiations regarding the termination of the lease for the Companys corporate headquarters (see Note 6), the Company wrote down and sold its assets no longer in use in accordance with FASB 144
Accounting for the Impairment or Disposal of Long-Lived Assets. The Company recorded an impairment charge of approximately $125,000 for the impairment of computer, office furniture, office equipment and leasehold improvements for which
the Company would not use or receive any compensation in the future. Offsetting the charge were net proceeds from the sale of the Companys laboratory equipment totaling $8,500, which resulted in a gain of approximately $2,000.
8.
|
New Accounting Pronouncements
|
In June 2006,
the FASB issued Interpretation No. 48
, Accounting for Uncertainty in Income Taxesan Interpretation of FASB Statement No. 109
(FIN 48). FIN 48 clarifies the accounting for uncertainty in income taxes
recognized in an entitys financial statements in accordance with SFAS No. 109, Accounting for Income Taxes, and prescribes a recognition threshold and measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax return. Additionally, FIN 48 provides guidance on subsequent derecognition of tax positions, financial statement classification, recognition of interest and penalties, accounting
in interim periods, and disclosure and transition requirements. The Company adopted the provisions of FIN 48 on January 1, 2007. Previously, the Company had accounted for tax contingencies in accordance with Statement of Financial Accounting
Standards 5,
Accounting for Contingencies
. As required by FIN 48, the Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain
the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon
ultimate settlement with the relevant tax authority. At the adoption date, the Company applied FIN 48 to all tax positions for which the statute of limitations remained open. The amount of unrecognized tax benefits as of January 1, 2007 was
zero. There have been no material changes in unrecognized tax benefits since January 1, 2007. As of January 1, 2007, due to the carry forward of unutilized net operating losses and research and development credits, the Company is subject
to U.S. Federal income tax examinations for the tax years 2002 through 2006, and to state income tax examinations for the tax years 1994 through 2006. The Company recognizes accrued interest related to unrecognized tax benefits in interest expense
and penalties in operating expense. No amounts were accrued for the payment of interest and penalties at January 1, 2007. The Companys adoption of FIN 48 did not have a material effect on the Companys financial condition, results of
operations or cash flows.
In February 2007, the FASB issued SFAS 159, The Fair Value Option for Financial Assets and Financial
Liabilities, which will be effective for public entities no later than the beginning of the first fiscal year beginning after November 15, 2007. The new standard allows entities to voluntarily choose, at specific election dates, to
measure many financial assets and financial liabilities (as well as certain nonfinancial instruments that are similar to financial instruments) at fair value (the fair value option). The election is made on an instrument-by-instrument
basis and is irrevocable. If the fair value option is elected for an instrument, the statement specifies that all subsequent changes in fair value for that instrument shall be reported in earnings (or another performance indicator for entities such
as not-for-profit organizations that do not report earnings). The Company will adopt this pronouncement on January 1, 2008 and is currently evaluating the impact that this pronouncement will have on its consolidated financial statements.
On October 9, 2007, the
Company entered into an Agreement and Plan of Merger (the Merger Agreement) with DARA.
Pursuant to the Merger Agreement, DARA
plans to merge with DP Acquisition Corp., a newly-formed subsidiary of the Company, with DARA surviving as a wholly-owned subsidiary of the Company (the Merger). DARA stockholders will receive shares of common stock of the Company
representing 96.4% outstanding common stock on a fully diluted basis of the combined company, which will change its name to DARA BioSciences, Inc. and be based in Raleigh, North Carolina. As a condition to the Merger Agreement, the Company will
effect a reverse stock split prior to the effective date of the Merger. The Merger is intended to be a tax-free reorganization under Section 368(a) of the Internal Revenue Code and is expected to close in the first quarter of 2008.
The Company and DARA cannot complete the Merger unless the Companys stockholders approve the issuance of shares of Point common stock in the
Merger and the reverse stock split, and DARAs stockholders approve the Merger Agreement, the Merger, and the other matters contemplated in the Merger Agreement. Additionally, the Merger is subject to other customary closing conditions,
including that the registration statement registering the shares of Point common stock to be issued in the Merger is declared effective by the Securities and Exchange Commission.
10
The executive officers and directors of DARA and the directors and former executive officers of the
Company have executed agreements pursuant to which they have agreed to vote the shares beneficially owned by them in favor of the Merger and the related transactions.
In addition, on October 9, 2007, the Company entered into a Loan and Security Agreement (the Loan Agreement) with DARA. The Loan Agreement provides for a loan facility under which the Company may
request cash advances from DARA, in a total aggregate amount of up to $400,000, to be used to pay for professional and other fees and expenses and other transaction costs incurred by the Company in connection with the proposed Merger.
The Loan Agreement provides that the Companys debt obligation under the Loan Agreement will be forgiven in its entirety (i) upon the
consummation of the Merger, (ii) if the Merger Agreement is terminated because the required approval of DARA stockholders is not received, (iii) if the Company terminates the Merger Agreement due to a breach by DARA or the occurrence of a
material adverse effect on DARA or (iv) if DARA terminates the Merger Agreement for a reason expressly disclosed to it by the Company in the disclosure schedules to the Merger Agreement. If the Merger is not consummated, the Loan Agreement
requires the Company to repay the full amounts actually borrowed under the credit facility on the earlier of (i) the commencement of bankruptcy proceedings by the Company, (ii) termination of the Merger Agreement, other than as a result of
DARAs failure to fulfill its obligations thereunder, or (iii) March 31, 2008. Borrowings under the credit facility bear interest at an annual rate of 5%. All of the Companys assets are pledged as collateral for any borrowings
under the Loan Agreement. The Loan Agreement contains various affirmative and negative covenants, including prohibitions on sales of assets and certain other corporate transactions.
The description of the Merger and related transactions in this report is qualified in its entirety by reference to the Merger Agreement and the Loan
Agreement. Copies of the Merger Agreement, the Loan Agreement and the related Note, as well as a copy of the press release issued on October 10, 2007, are attached as Exhibits to the Companys Report on Form 8-K filed with the SEC on
October 10, 2007.
11
Item 2.
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
Cautionary Factors with Respect to Forward-Looking Statements
Readers are cautioned that certain
statements contained in this Managements Discussion and Analysis of Financial Condition and Results of Operations that are not related to historical results are forward-looking statements as defined in the Private Securities
Litigation Reform Act of 1995, as from time-to-time in effect. This information includes statements on the prospects for our drug development activities and results of operations based on our current expectations, such as statements regarding
certain milestones with respect to our clinical program and our product candidates. Forward-looking statements are statements that are not historical facts, and can be identified by, among other things, the use of forward-looking language, such as
believe, expect, may, will, should, seeks, plans, schedule to, anticipates or intends or the negative of those terms, or
other variations of those terms of comparable language, or by discussions of strategy or intentions. A number of important factors could cause actual results to differ materially from those projected or suggested in the forward looking statement,
including, but not limited to, our ability to (1) receive stockholder approvals and complete our merger with DARA, (2) successfully locate a buyer or partner for the purposes of effectuating a strategic transaction if our merger with DARA
is not successful, (3) continue as a going concern, (4) comply with certain NASDAQ Marketplace Rules, and (5) enforce our intellectual property rights, as well as the risk factors discussed elsewhere in this report.
Overview
We are a biopharmaceutical
company which has studied our lead product candidate, talabostat, in a number of human clinical trials in late-stage cancers. May 2007 interim clinical results caused our Independent Data Monitoring Committee to recommend stopping our most advanced
clinical trials, two Phase 3 talabostat studies for patients in advanced non-small cell lung cancer. Subsequently, the talabostat clinical development program was put on clinical hold by the U.S. Food and Drug Administration (FDA). We
have also studied talabostat in several Phase 2 trials, including as a single-agent and in combination with cisplatin in metastatic melanoma, in combination with rituximab in advanced chronic lymphocytic leukemia, and in combination with gemcitabine
in Stage IV pancreatic cancer. Due to cash limitations, we are not currently funding any research or clinical operations.
On
October 9, 2007, we entered into a definitive agreement to merge with DARA pursuant to which DARA will merge with DP Acquisition Corp., our newly-formed subsidiary, with DARA surviving as a wholly-owned subsidiary. After giving effect to the
merger, DARA stockholders will hold 96.4% of our outstanding shares of common stock on a fully-diluted basis, and we will change our name to DARA BioSciences, Inc. and be based in Raleigh, North Carolina (see Note 9 to the Financial Statements found
elsewhere in this Report on Form 10-Q).
To date, we have generated no revenues from product sales and have primarily depended upon equity
financings, interest earned on invested funds, and collaboration payments received from pharmaceutical companies and government agencies to provide the working capital required to pursue our intended business activities. We have a net accumulated
deficit of approximately $102,705,000 as of September 30, 2007. The accumulated deficit has resulted principally from our efforts to develop drug candidates and the associated administrative costs required to support these efforts.
Effective July 25, 2007, we terminated all but two of our employees. We are utilizing some of our recently terminated executives as part of a
more variable-cost consulting team to assist us in completing the merger with DARA. In addition, on July 31, 2007, we terminated our lease at 155 Federal Street in Boston, Massachusetts and moved to a substantially smaller temporary location.
We may be unable to successfully complete the merger with DARA or to locate another buyer or partner for the purposes of effecting another strategic transaction if the merger fails. Although we currently retain control over our intellectual property
portfolio, we cannot make any assurances that these assets have or will continue to have any value. This uncertainty as to the value of our intellectual property portfolio and other assets may prevent us from locating another buyer or partner for
the purposes of effecting another strategic transaction if the merger with DARA fails.
If our attempts to complete the merger with DARA
fail and if no other strategic transaction can be completed, we will likely file for federal bankruptcy protection under Chapter 11 of the Bankruptcy Code. In the event that we do file for Chapter 11 protection, we will most likely not be able to
raise any type of funding from any source. Upon filing for Chapter 11 protection, we would not meet the minimum standards required for remaining listed on the NASDAQ Capital Market. If we are delisted, our stock would no longer be tradable on the
NASDAQ Capital Market.
12
Our principal executive office is located at 70 Walnut Street, Wellesley Hills, Massachusetts, 02481 and
our telephone number is (781) 239-7502. Our common stock trades on the NASDAQ Capital Market under the symbol POTP. Our website is
www.pther.com.
Critical Accounting Policies and Significant Judgments and Estimates
Critical Accounting Policies
Clinical Trial Expenses.
We record the estimated cost of patient recruitment and related supporting functions for our clinical
trial as patients are enrolled in the trial. We record the costs for the trials based on a percentage of completion basis. In the past, our estimates have been materially accurate with the actual billings received. These costs consist primarily of
payments made to the outside clinical management organizations, clinical centers, investigators, testing facilities and patients for participating in our clinical trial. As actual or expected costs become known, they may differ from estimated costs
previously accrued for and this clinical trial accrual or prepaid would be adjusted accordingly. At September 30, 2007, we had no prepaid and deposit balances related to clinical trials. At September 30, 2007, there was $36,000 of accrued
expenses related to clinical trials. Clinical trial expenses were $0 and $2,493,000 for the three month periods ended September 30, 2007 and 2006, respectively and $2,377,000 and $7,797,000 for the nine month periods ended September 30,
2007 and 2006, respectively.
Stock-based Compensation.
Effective January 1, 2006, we adopted the fair value recognition
provisions of Statement of Financial Accounting Standards No. 123R,
Share-Based PaymentAn Amendment of FASB Statements No. 123 and 95,
or SFAS No. 123R. SFAS No. 123R requires companies to measure compensation cost
for all share-based awards at fair value on grant date and recognize it as expense ratably over the requisite service period of the award. We use the Black-Scholes option pricing model to calculate the fair value of share-based awards on the
grant date. This option pricing model requires the input of highly subjective assumptions, including the term during which the awards are expected to be outstanding and the price volatility of the underlying stock. In addition, SFAS
No. 123R requires forfeitures, which represent only the unvested portion of a surrendered award, to be estimated at the time of the grant and revised, if necessary, in subsequent periods. Please refer to Note 2Summary of Significant
Accounting Principles, included in the condensed consolidated financial statements appearing elsewhere in this report, for additional information regarding our adoption of SFAS No. 123R.
Significant Judgments and Estimates.
The preparation of our consolidated financial statements in conformity with accounting principles
generally accepted in the United States requires that we make estimates and assumptions that affect the reported amounts and disclosure of certain assets and liabilities at our balance sheet date. Such estimates include the carrying value of
property and equipment and the value of certain liabilities. Actual results may differ from such estimates.
Results of Operations
Revenue
For the three and nine
month periods ended September 30, 2007, we did not recognize any revenue.
For the three month period ended September 30, 2006,
we recognized $220,000 in revenue. For the nine month period ended September 30, 2006, we recognized revenue totaling $359,000 relating to the $600,000 Orphan Drug Grant (the Grant) from the FDA to partially fund our Phase 2 CLL
clinical trial. No future amounts are anticipated to be received under the Grant.
Operating Expenses
Research and Development
During the three and nine month periods ending September 30, 2007 and 2006, almost all of our research and development efforts were focused on the preclinical and clinical development of talabostat for the treatment of solid tumors and
hematologic malignancies. In addition, during the nine month period ending September 30, 2007, the Company incurred costs associated with an interim analysis of its two Phase 3 studies and termination costs related to headcount reductions.
On May 21, 2007, we announced that the FDA has placed the clinical program for
talabostat on clinical hold as a result of the interim analyses of our two Phase 3 talabostat studies as a potential treatment for patients with advanced non-small cell lung cancer (NSCLC). Our Independent Data Monitoring Committee recommended
stopping both studies due to the primary endpoint of median progression-free survival (PFS) or the secondary endpoint of overall survival demonstrated no statistical improvement over the respective placebo groups. In addition, in the talabostat
combination trial with docetaxal (Taxotere
®
: sanofi-aventis), the talabostat arm of the study demonstrated significantly lower overall survival than the placebo arm. Subsequent to us
informing the FDA of the interim results, the FDA put our talabostat clinical program on hold.
13
Research and development expenses decreased 94.4% to $375,000 for the three month period ended
September 30, 2007 from $6,731,000 for the three month period ended September 30, 2006. Research and development expenses decreased 69.3% to $5,823,000 for the nine-month period ended September 30, 2007 from $18,984,000 for the
nine-month period ended September 30, 2006.
Clinical and drug development:
Clinical and drug development expenses include
costs of drug development and conducting clinical trials. Such costs include costs of personnel (including salary, fringe benefits, severance, recruiting and relocation costs), drug supply and testing costs and facility expenses, including
depreciation.
Total clinical and drug development expenses decreased 98.9% to $60,000 for the three month period ended September 30,
2007 from $5,850,000 for the three month period ended September 30, 2006. The decrease was due to the termination of our clinical program during the second quarter of 2007.
For the nine month period ended September 30, 2007, clinical and drug development expenses decreased 69.6% to $4,784,000 from $15,762,000 for the
nine month period ended September 30, 2006. The decrease of $10,978,000 was due to the termination of our clinical program and the termination of all employees in this area during the second quarter of 2007. During the nine month period ended
September 30, 2007, we recorded retention bonuses of $306,000 which were paid to non-executive employees in May 2007 and severance in the amount of $160,000 for headcount reductions in this area.
During the remainder of 2007, we anticipate that we will not incur any costs in the clinical and drug development area.
Research:
Research includes expenses associated with research and testing of our product candidates supporting the clinical development of
talabostat and our other preclinical candidates prior to reaching the clinical development stage. Such expenses primarily include the costs of internal personnel, outside contractors, facilities, including depreciation, and laboratory supplies.
Research expenses decreased 64.2% to $315,000 for the three month period ended September 30, 2007 from $881,000 for the three month
period ended September 30, 2006. The decrease was primarily due to the shut-down of our internal research laboratory in December 2006. During the three month period ended September 30, 2007, we recorded severance totaling $304,000.
For the nine month period ended September 30, 2007, research expenses decreased 67.7% to $1,040,000 from $3,222,000 for the nine
month period ended September 30, 2006. The decrease was due to the shut-down of our internal research laboratory in December 2006. During the nine month period ended September 30, 2007, we recorded retention bonuses of $12,000 which were
paid to non-executive employees in May 2007 and severance totaling $404,000 for headcount reductions.
All operations in the Research area
were terminated in June 2007. During the remainder of 2007, we anticipate that we will not incur any material costs in the research area with the exception of costs related to the upkeep of our mice population at an offsite facility.
General and Administrative
General and administrative:
General and administrative costs include the associated administrative costs required to support the clinical development and research efforts such as legal, finance and accounting, business
development, investor relations and other administrative support functions.
General and administrative expenses increased 33.2% to
$2,072,000 during the three month period ended September 30, 2007 from $1,556,000 for the three month period ended September 30, 2006. The increase in general and administrative expenses resulted primarily from severance benefits incurred
upon the reduction in headcount in July, 2007. During the three month period ended September 30, 2007, we recorded severance expenses totaling $1,138,000 for headcount reductions, legal and patent costs totaling $303,000 to pursue a strategic
transaction and maintain our patent portfolio and salaries and related fringes of $187,000. We also recorded rent expense of $251,000 for our corporate headquarters at 155 Federal Street which included a charge to terminate the lease of
approximately $220,000, which consisted of a payment of $330,000 offset by a reduction in accrued rent expense of approximately $114,000.
For the nine month period ended September 30, 2007, general and administrative expenses increased 2.0% to $5,391,000 from $5,287,000 for the nine month period ended September 30, 2006. The increase in general and administrative
expenses primarily resulted from severance benefits incurred upon the reduction in headcount in July, 2007 offset by a reduction in Companys operations. During the nine month period ended September 30, 2007, we recorded severance expenses
totaling $1,168,000 for headcount reductions, legal and patent costs totaling $1,139,000 to pursue a strategic transaction and maintain our patent portfolio, a loss for the impairment of fixed assets of $123,000 and retention bonuses, which were
paid to non-executive employees, of $68,000 in May 2007.
14
During the remainder of 2007, we anticipate that general and administrative expenses will decrease
depending on the strategic direction of the Company. We have recently terminated all but two employees in this area. We also retained certain members of our senior management team as part of a more variable-cost consultant team to assist us as we
complete the proposed merger with DARA, or if the merger fails, to assist us in seeking a buyer or partner for our technology and related intellectual property and other assets, in bankruptcy or otherwise.
Non-Cash Stock Based Compensation
For the three month period ended September 30, 2007, we recorded a credit of non-cash stock-based compensation expense in accordance with SFAS No. 123R of $203,000 for stock options granted to employees and outside directors under
our stock option plans, of which $56,000 was included in research and development expenses and $146,000 was included in general and administrative expenses. For the three month period ended September 30, 2006, we recorded non-cash stock-based
compensation expense of $488,000 for stock options granted under our stock option plans, of which $262,000 was included in research and development expenses and $226,000 was included in general and administrative expenses.
For the nine month period ended September 30, 2007, we recorded non-cash stock-based compensation expense of $169,000 for stock options granted
under our stock option plans, of which a credit in the amount of $186,000 was recorded in research and development expenses and a credit of $355,000 was recorded in general and administrative expenses. For the nine-month period ended
September 30, 2006, we recorded non-cash stock-based compensation expense of $1,613,000 for stock options granted under our stock option plans, of which $778,000 was recorded in research and development expenses and $835,000 was included in
general and administrative expenses.
Interest Income
Interest income includes interest earned on invested cash balances. During the three month periods ended September 30, 2007 and 2006, our investments
consisted entirely of funds deposited in money market funds.
Interest income decreased 85.1% to $36,000 in the three month period ended
September 30, 2007 from $241,000 in the three month period ended September 30, 2006. Interest income decreased 72.5% to $243,000 in the nine month period ended September 30, 2007 from $884,000 in the nine month period ended
September 30, 2006. The decrease in interest income in both the three and nine month periods resulted primarily from a lower average cash balance.
Net loss
As a result of the foregoing, we incurred a net loss of $2,410,000, or $0.06 per
common share, for the three month period ended September 30, 2007 compared to a net loss of $7,856,000, or $0.24 per common share, for the three month period ended September 30, 2006 and a net loss of $10,971,000, or $0.29 per common
share, for the nine month period ended September 30, 2007 as compared to a net loss of $23,028,000, or $0.70 per common share, for the nine month period ended September 30, 2006.
Liquidity and Capital Resources
At
September 30, 2007, our principal sources of liquidity were cash and cash equivalents which totaled $2,311,000.
During the nine month
period ended September 30, 2007, our cash and cash equivalents decreased $7,487,000 as compared to December 31, 2006.
During the
nine month period ended September 30, 2007, the decrease in net cash used in operations resulted primarily from a net loss of $9,656,000. Included in the net loss for the nine month period ended September 30, 2007 were non-cash stock-based
compensation of $169,000, an impairment charge of $123,000 and depreciation of $76,000. Restricted cash decreased by $300,000 to $0 due to the termination of our lease for our corporate headquarters at 155 Federal Street effective July 31,
2007. Prepaid expenses, deposits and other assets, net, decreased $1,418,000 for the nine month period ended September 30, 2007, resulting primarily from a refund of prepaid costs we received from a clinical testing vendor when we terminated
services for our clinical trials and an adjustment to the amount due to us from our clinical management organization for which payment was received in July 2007. Offsetting these decreases were insurance premiums paid. Our unbilled receivable
decreased by $3,000 and accounts payable and accrued expenses decreased $2,998,000 during the nine month period ended September 30, 2007, resulting primarily from the payment of the majority of clinical and manufacturing related expenses for
our Phase 3 clinical program, offset somewhat by an increase in contractual severance benefits incurred but not yet paid.
15
During the nine month period ended September 30, 2007, we received $8,500 from the sale of a piece
of laboratory equipment.
Our financing activities provided net cash of $4,384,000 for the nine month period ended September 30, 2007,
primarily related to the registered direct offering (the Offering) from the sale of 6,523,776 shares of our common stock at a price of $0.73 per share. Gross proceeds from the February 7, 2007 Offering were $4,762,000. After
placement agent fees of approximately $286,000 and other expenses related to the Offering totaling approximately $85,000, net proceeds to us were $4,391,000. We also received $4,000 from the exercise of stock options during the nine month period
ended September 30, 2007.
Capital Resources
At September 30, 2007, we had $2,311,000 in cash and cash equivalents. We currently anticipate that our existing capital resources will be sufficient to allow us to maintain our current and planned operations
into the first quarter of 2008 and the completion of the proposed merger with DARA. Our cash balance at September 30, 2007, and amounts we would receive, were we to liquidate all of our assets, after taking into account all anticipated uses of
the cash, may not be sufficient to pay all amounts on or in respect of our obligations when such amounts are required to be paid. These conditions raise substantial doubt about our ability to continue as a going concern. The audit report prepared by
our independent registered public accounting firm in connection with our financial statements for the year ended December 31, 2006 included an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern.
Our expectations regarding our rate of spending and the sufficiency of our cash resources over future periods are forward-looking
statements. Our funding requirements are dependent on our ability to seek a buyer or partner for our technology and related intellectual property and other assets. Effective July 25, 2007, we terminated all but two of our employees. We have
retained certain members of our senior management team as consultants as part of a more variable-cost consulting team to assist us in completing the proposed merger with DARA, or, if the merger fails, to seek a buyer or partner for our technology
and related intellectual property and other assets, in bankruptcy or otherwise. On July 31, 2007, we terminated our lease at 155 Federal Street for a substantially smaller temporary location. Given our limited staff and resources, if we are
unable to successfully complete the merger with DARA, we may not be able to locate a buyer or partner for the purposes of effectuating another strategic transaction. Although we currently retain control over our intellectual property portfolio, we
cannot make any assurances that these assets have or will continue to have any value. This uncertainty as to the value of our intellectual property portfolio and other assets may prevent us from locating another buyer or partner for the purposes of
enacting another strategic transaction if the DARA merger cannot be successfully completed.
If our proposed merger with DARA fails, and
our attempts to find another buyer or partner for our technology and related intellectual property and assets fail, and if no other strategic transaction can be effectuated, we will likely file for federal bankruptcy protection under Chapter 11 of
the Bankruptcy Code. In the event we do file for Chapter 11 protection, we will most likely not be able to raise any type of funding from any source. Upon filing for Chapter 11 protection, we will not meet the minimum standards required for
remaining listed on the NASDAQ Capital Market. If we are delisted, our stock would no longer be tradable on the NASDAQ Capital Market.
Contractual
Obligations
As of September 30, 2007, we had future payments required under contractual obligations and other commitments
approximately as follows:
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Payments Due By Year
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Q4 2007
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2008
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2009
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|
2010
|
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2011
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Thereafter
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Total
|
Operating Leases(1)
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$
|
20,000
|
|
$
|
25,000
|
|
$
|
13,000
|
|
$
|
13,000
|
|
$
|
12,000
|
|
$
|
|
|
$
|
83,000
|
Capital Leases
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|
Licensing Obligations
|
|
|
|
|
|
10,000
|
|
|
10,000
|
|
|
10,000
|
|
|
10,000
|
|
|
8,000
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|
|
48,000
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Total Future Obligations
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$
|
20,000
|
|
$
|
35,000
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|
$
|
23,000
|
|
$
|
23,000
|
|
$
|
22,000
|
|
$
|
8,000
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|
$
|
131,000
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(1)
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On July 26, 2007, the Company reached an agreement with its landlord, KNH Realty Trust (KNH) to terminate the lease for its corporate offices at 155 Federal Street
in Boston, Massachusetts (the Termination Agreement) effective July 31, 2007. The Termination Agreement provides for a one time payment of $330,000 by the Company to KNH in consideration of releasing the Company from all of its
obligations under its lease, dated as of March 16, 2005, the term of which otherwise ran until July 1, 2010. The one-time payment will be recorded by the Company in the third quarter of 2007. In addition, the Company agreed to transfer
ownership of all of its furniture, office equipment and leasehold improvements to KNH, all of which were written down to zero at June 30, 2007.
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16
If we are able to complete the proposed merger with DARA or another strategic transaction, additional
severance and related fringes in the amount of approximately $1,240,000 will be paid to certain former executives of Point in accordance with their employment contracts. At September 30, 2007, we have recorded this amount as a liability on our
Consolidated Balance Sheet.
In addition, in accordance with the license agreement between us and Tufts University School of Medicine
(Tufts), we are required to make payments totaling $250,000 to Tufts upon marketing application of the first licensed product and marketing approval of the first licensed product. We are also required to pay a royalty based on future
sales of products covered under the license agreement.
Off-Balance Sheet Arrangements
We had no off-balance sheet arrangements as of September 30, 2007 that have or are reasonably likely to have a current or future effect on our
financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
New Accounting Pronouncements
In June 2006, the FASB issued Interpretation No. 48
,
Accounting for Uncertainty in Income Taxesan Interpretation of FASB Statement No. 109
(FIN 48). FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an entitys financial
statements in accordance with SFAS No. 109, Accounting for Income Taxes, and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to
be taken in a tax return. Additionally, FIN 48 provides guidance on subsequent derecognition of tax positions, financial statement classification, recognition of interest and penalties, accounting in interim periods, and disclosure and transition
requirements. We adopted the provisions of FIN 48 on January 1, 2007. Previously, we had accounted for tax contingencies in accordance with Statement of Financial Accounting Standards 5,
Accounting for Contingencies
. As
required by FIN 48, we recognize the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the
more-likely-than-not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. At the adoption
date, we applied FIN 48 to all tax positions for which the statute of limitations remained open. The amount of unrecognized tax benefits as of January 1, 2007 was zero. There have been no material changes in unrecognized tax benefits since
January 1, 2007. As of January 1, 2007, due to the carry forward of unutilized net operating losses and research and development credits, we are subject to U.S. Federal income tax examinations for the tax years 1994 through 2006, and to
state income tax examinations for the tax years 2002 through 2006. We recognize accrued interest related to unrecognized tax benefits in interest expense and penalties in operating expense. No amounts were accrued for the payment of interest and
penalties at January 1, 2007. Our adoption of FIN 48 did not have a material effect on our financial condition, results of operations or cash flows.
In February 2007, the FASB issued SFAS 159, The Fair Value Option for Financial Assets and Financial Liabilities, which will be effective for public entities no later than the beginning of the first fiscal
year beginning after November 15, 2007. The new standard allows entities to voluntarily choose, at specific election dates, to measure many financial assets and financial liabilities (as well as certain nonfinancial instruments that are similar
to financial instruments) at fair value (the fair value option). The election is made on an instrument-by-instrument basis and is irrevocable. If the fair value option is elected for an instrument, the Statement specifies that all
subsequent changes in fair value for that instrument shall be reported in earnings (or another performance indicator for entities such as not-for-profit organizations that do not report earnings). We will adopt this pronouncement on January 1,
2008 and are currently evaluating the impact that this pronouncement will have on our consolidated financial statements.