TetraLogic Reports 2014 Financial Results and Provides Clinical Programs Update
26 Febrero 2015 - 3:10PM
TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG), a
clinical-stage biopharmaceutical company focused on discovering and
developing novel small molecule therapeutics in oncology and
infectious diseases, today announced financial results for the year
ended December 31, 2014. These results are included in TetraLogic's
Annual Report on Form 10-K which has been filed with the Securities
and Exchange Commission.
"The TetraLogic team achieved several significant milestones in
2014," said J. Kevin Buchi, President and Chief Executive Officer
of TetraLogic. "We advanced birinapant into two randomized Phase 2
trials; we also acquired a second asset, SHAPE, and commenced a
randomized Phase 2 trial with that molecule as well."
Summary of Key Development Programs, Updates and
Anticipated Milestones
- Birinapant HBV Program: Based upon preclinical assays in which
birinapant-treated mice demonstrated clearance of hepatitis B
surface antigen (HBsAg) and the formation of antibodies to HBsAg,
we have commenced enrollment in a multiple ascending dose clinical
trial of birinapant in subjects with chronic hepatitis B. The trial
is being conducted in subjects over the age of 18 with hepatitis B
who are receiving treatment with either tenofovir or entecavir and
who are HBsAg positive. The trial is expected to enroll
approximately 6 cohorts of 8 subjects each, who will receive 4
weekly treatments with either birinapant or placebo in a 3:1 ratio.
The study is being conducted at multiple clinical sites in
Australia. Although predominantly a safety and tolerability study,
patients are being monitored for reductions in HBsAg and the
formation of antibodies to HBsAg, as indications of therapeutic
activity.
- Birinapant MDS Program: In May 2014, we announced that,
based upon data from our Phase 1b study of birinapant in
combination with azacitidine in patients with higher risk MDS who
are either relapsed/refractory or naïve to azacitidine, we
initiated a randomized Phase 2 clinical trial in first line higher
risk MDS patients. While the primary objective of the Phase 1b
clinical study was to characterize the safety and tolerability and
determine the recommended Phase 2 dose of birinapant when
administered in combination with azacitidine, we did observe bone
marrow responses in a number of patients who had relapsed or were
refractory to azacitidine.
- SHAPE CTCL Program: In April 2014, we acquired Shape
Pharmaceuticals, Inc. In May 2014, safety and efficacy data from
the Phase 1b randomized placebo controlled clinical study of SHAPE,
our topical HDAC inhibitor, in Stage IA –IIA Cutaneous T-cell
Lymphoma (CTCL) were presented at the annual Society of
Investigative Dermatology meeting and at American Society of
Clinical Oncology meeting. In December 2014, we commenced a
randomized Phase 2 clinical trial of SHAPE in early stage CTCL.
- Birinapant/conatumumab Program: We are continuing
enrollment in a Phase 1/2 study of birinapant in combination with
conatumumab, Amgen's TRAIL agonist antibody, in 3rd line ovarian
cancer. In December 2014 this clinical trial proceeded
into a Phase 2a expansion based upon data in the Phase 1 portion of
the trial.
We expect data from all studies to be available in 2015, making
this an important year for TetraLogic.
Full Year 2014 Financial Highlights
- Cash, cash equivalents, and marketable securities totaled $53.7
million at December 31, 2014, as compared to $55.1 million at
December 31, 2013.
- Research and Development expenses were $19.4 million in 2014,
excluding $0.9 million in non-cash, stock based compensation
expense, compared to $8.6 million in 2013, excluding $0.9 million
in non-cash, stock based compensation expense. The increase
primarily results from additional costs associated with clinical
trials, including the manufacturing and formulation of our clinical
drug supplies.
- General and Administrative expenses were $8.5 million in 2014,
excluding $2.5 million in non-cash, stock based compensation
expense, compared to $5.6 million in 2013, excluding $2.8 million
in non-cash, stock based compensation expense.
- Adjusted net loss for 2014 was $29.7 million, compared to an
adjusted net loss of $17.0 million in 2013. Adjusted net loss
excludes (i) non-cash stock based compensation expense; (ii)
non-cash interest expense; (iii) non-cash fair value adjustments to
the company's derivative liabilities; and (iv) non-cash fair value
adjustments to the contingent consideration liability recognized as
part of the Shape acquisition in April 2014.
- Shares issued and outstanding as of December 31, 2014 were 22.3
million, not including outstanding stock options to purchase 3.3
million shares and 7.0 million shares underlying the company's
outstanding convertible notes.
Non-GAAP Financial Measures
In the attached press release, the Company discloses "Adjusted
net loss," "Basic adjusted net loss per common share," and "Diluted
adjusted net loss per common share" for certain historical periods,
all of which are considered "non-GAAP financial measures" under
Securities and Exchange Commission rules. A "non-GAAP
financial measure" is defined as a numerical measure of a company's
historical or future financial performance, financial position or
cash flows that excludes (or includes) amounts, or is subject to
adjustments that have the effect of excluding (or including)
amounts, that are included in (or excluded from) the most directly
comparable measure calculated and presented in accordance with GAAP
in the Company's financial statements. Management does not intend
the presentation of non-GAAP financial measures to be considered in
isolation or as a substitute for results prepared in accordance
with GAAP.
For all periods presented, the Company reconciles net loss on a
GAAP basis to adjusted net loss. Management believes that the
presentation of these adjusted measures is useful to investors
because it provides a means of evaluating the Company's operating
performance and results from period to period on a comparable basis
not otherwise apparent on a GAAP basis, since many non-cash,
infrequent, or unusual charges, including items that may not affect
the Company's operations, do not meet the strict GAAP definition of
unusual non-recurring items. Furthermore, in preparing
operating plans, budgets and forecasts, and in assessing historical
performance, management relies, in part, on trends in the Company's
historical results, exclusive of these items. Finally, management
believes that this presentation is useful in facilitating
comparisons between the Company and other companies in its
industry, many of whom exclude similar items.
About TetraLogic Pharmaceuticals
Corporation
TetraLogic is a clinical-stage biopharmaceutical company focused
on discovering and developing novel small molecule therapeutics in
oncology and infectious diseases. TetraLogic has two clinical-stage
product candidates in development: birinapant and SHAPE. Birinapant
is currently being tested in Phase 1 and Phase 2 clinical trials
for hematological malignancies and solid tumors, and is also being
tested in a Phase 1b/2a clinical trial in hepatitis B. SHAPE is
currently being tested in a Phase 2 clinical trial for early-stage
cutaneous T‑cell lymphoma.
Forward Looking Statements
Some of the statements in this release are forward looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. These statements relate to future
events or TetraLogic's pre-clinical and clinical development of
birinapant, SHAPE and other clinical programs, future expectations,
plans and prospects. Although TetraLogic believes that the
expectations reflected in such forward-looking statements are
reasonable as of the date made, expectations may prove to have been
materially different from the results expressed or implied by such
forward-looking statements. TetraLogic has attempted to
identify forward looking statements by terminology including
''believes,'' ''estimates,'' ''anticipates,'' ''expects,''
''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,''
''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. These statements
are only predictions and involve known and unknown risks,
uncertainties, and other factors, including those discussed under
the heading "Risk Factors" in our Annual Report on Form 10-K filed
with the U.S. Securities and Exchange Commission (SEC) on February
26, 2015. Any forward-looking statements contained in this
release speak only as of its date. We undertake no obligation
to update any forward-looking statements contained in this release
to reflect events or circumstances occurring after its date or to
reflect the occurrence of unanticipated events.
|
TetraLogic
Pharmaceuticals Corporation |
Consolidated Statements
of Operations and Comprehensive Loss |
|
|
|
|
|
|
|
|
Three months ended
December 31, |
Year ended December
31, |
|
2013 |
2014 |
2013 |
2014 |
|
|
|
|
|
Revenues |
$ – |
$ – |
$ – |
$ – |
|
|
|
|
|
Expenses: |
|
|
|
|
General and
administrative |
4,320,175 |
2,790,042 |
8,467,467 |
10,926,777 |
Research and
development |
3,084,486 |
6,331,707 |
9,523,427 |
20,286,826 |
Change in fair value of
contingent consideration |
– |
670,000 |
– |
2,572,000 |
Total expenses |
7,404,661 |
9,791,749 |
17,990,894 |
33,785,603 |
|
|
|
|
|
Loss from operations |
(7,404,661) |
(9,791,749) |
(17,990,894) |
(33,785,603) |
|
|
|
|
|
Change in fair value of derivative
liabilities |
2,142,118 |
(564,183) |
807,291 |
1,073,198 |
Interest and other income |
564 |
40,244 |
629 |
112,815 |
Interest expense |
(1,392,044) |
(1,624,668) |
(2,767,422) |
(3,359,389) |
Net loss |
$ (6,654,023) |
$ (11,940,356) |
$ (19,950,396) |
$ (35,958,979) |
Cumulative preferred stock dividends |
(684,240) |
– |
(3,249,948) |
– |
Net loss attributable to common
stockholders |
$ (7,338,263) |
$ (11,940,356) |
$ (23,200,344) |
$ (35,958,979) |
|
|
|
|
|
Per share information: |
|
|
|
|
Net loss per common
share: |
|
|
|
|
Basic |
$ (1.38) |
$ (0.53) |
$ (10.11) |
$ (1.61) |
Diluted |
$ (1.38) |
$ (0.53) |
$ (10.11) |
$ (1.63) |
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
Basic |
5,314,148 |
22,319,258 |
2,295,636 |
22,290,069 |
Diluted |
5,314,148 |
22,319,258 |
2,295,636 |
22,351,689 |
|
|
|
|
|
Net loss |
$ (6,654,023) |
$ (11,940,356) |
$ (19,950,396) |
$ (35,958,979) |
Foreign currency gains/(losses) |
-- |
(30,027) |
-- |
(69,031) |
Unrealized gains/(losses) on
available-for-sale securities |
-- |
(7,748) |
-- |
(8,117) |
Comprehensive loss |
$ (6,654,023) |
$ (11,978,131) |
$ (19,950,396) |
$ (36,036,127) |
|
|
TetraLogic
Pharmaceuticals Corporation |
Reconciliation of GAAP
Net Loss to Adjusted Net Loss |
|
|
|
|
|
|
|
|
|
|
In accordance with Regulation G
of the Securities and Exchange Commission, the table set forth
below reconciles certain financial measures used in this press
release that are not calculated in accordance with generally
accepted accounting principles, or GAAP, with the most directly
comparable financial measure calculated in accordance with
GAAP. |
|
|
|
|
|
|
|
|
|
|
Three months ended
December 31, |
|
Year ended December
31, |
|
|
2013 |
|
2014 |
|
2013 |
|
2014 |
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders
- GAAP |
$ (7,338,263) |
|
$ (11,940,356) |
|
$ (23,200,344) |
|
$ (35,958,979) |
|
|
|
|
|
|
|
|
|
|
General and administrative
adjustments |
2,446,662 |
(1) |
654,864 |
(1) |
2,821,584 |
(1) |
2,450,986 |
(1) |
Research and development
adjustments |
714,659 |
(1) |
243,459 |
(1) |
886,808 |
(1) |
933,814 |
(1) |
Change in fair value of
contingent consideration |
-- |
|
1,330,000 |
(2) |
-- |
|
2,572,000 |
(2) |
Change in fair value of
derivative liabilities |
(2,142,118) |
(3) |
564,183 |
(3) |
(807,291) |
(3) |
(1,073,198) |
(3) |
Interest expense |
-- |
|
684,668 |
(4) |
-- |
|
1,395,833 |
(4) |
Cumulative preferred stock
dividends |
684,240 |
(5) |
-- |
|
3,249,948 |
(5) |
-- |
|
|
1,703,443 |
|
3,477,174 |
|
6,151,049 |
|
6,279,435 |
|
|
|
|
|
|
|
|
|
|
Adjusted net loss |
$ (5,634,820) |
|
$ (8,463,182) |
|
$ (17,049,295) |
|
$ (29,679,544) |
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
Adjusted net loss per common
share: |
|
|
|
|
|
|
|
|
Basic |
$ (1.06) |
|
$ (0.38) |
|
$ (7.43) |
|
$ (1.33) |
|
Diluted |
$ (1.06) |
|
$ (0.38) |
|
$ (7.43) |
|
$ (1.35) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
|
Basic |
5,314,148 |
|
22,319,258 |
|
2,295,636 |
|
22,290,069 |
|
Diluted |
5,314,148 |
|
22,319,258 |
|
2,295,636 |
|
22,351,689 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes to Reconciliation
of GAAP Net Loss to Adjusted Net Loss |
|
|
|
|
|
|
|
|
|
(1) To exclude non-cash charges
for stock compensation expense. |
|
|
|
|
|
|
|
|
|
(2) In 2014, to exclude the
change in fair value of contingent consideration related to the
acquisition of Shape Pharmaceuticals, Inc. |
|
|
|
|
|
|
|
|
|
(3) To exclude the change in fair
value of our warrant liabilities and, in 2014, the change in fair
value of the interest make-whole derivative related to our 8%
Convertible Notes. |
|
|
|
|
|
|
|
|
|
(4) In 2014, to exclude the
amortization of debt discount and the amortization of deferred
financing costs related to our 8% Convertible Notes. |
|
|
|
|
|
|
|
|
|
(5) In 2013, to exclude
cumulative dividends on our series C and C-1 convertible preferred
stock. |
|
|
TetraLogic
Pharmaceuticals Corporation |
Consolidated Balance
Sheets |
|
|
|
|
December 31, |
December 31, |
|
2013 |
2014 |
Assets |
|
|
Current assets: |
|
|
Cash and cash
equivalents |
$ 55,135,508 |
$ 13,073,137 |
Short-term
investments |
— |
40,624,349 |
Deferred financing costs,
short-term |
— |
375,808 |
Prepaid expenses and other
current assets |
153,210 |
1,784,069 |
Restricted cash |
20,000 |
— |
Total current assets |
55,308,718 |
55,857,363 |
Property and equipment, net |
139,577 |
528,476 |
Intangible assets |
— |
41,575,516 |
Goodwill |
— |
16,902,466 |
Deferred financing costs, long-term |
— |
1,299,674 |
Other assets |
54,126 |
2,127,551 |
Total assets |
$ 55,502,421 |
$ 118,291,046 |
|
|
|
Liabilities and stockholders'
equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 1,215,198 |
$ 1,138,470 |
Accrued expenses |
2,921,458 |
3,727,784 |
Derivative liabilities |
793,744 |
256,027 |
Total current liabilities |
4,930,400 |
5,122,281 |
Convertible notes
payable, net of discount of $18,020,658 |
— |
28,979,342 |
Derivative
liabilities |
— |
2,400,000 |
Deferred taxes |
— |
16,879,659 |
Contingent consideration and
other liabilities |
22,968 |
31,507,588 |
Total liabilities |
4,953,368 |
84,888,870 |
|
|
|
Commitments and contingencies |
|
|
Stockholders' equity: |
|
|
Preferred stock, $0.0001 par
value; 25,000,000 shares authorized, none issued and
outstanding |
— |
— |
Common stock, $0.0001 par
value; 100,000,000 shares authorized, 22,199,256 and 22,307,138
shares issued and outstanding at December 31, 2013 and
September 30, 2014, respectively |
2,220 |
2,234 |
Additional paid-in
capital |
140,419,071 |
159,308,307 |
Cumulative unrealized loss on
investments |
— |
(8,117) |
Cumulative translation
adjustment |
— |
(69,031) |
Accumulated deficit |
(89,872,238) |
(125,831,217) |
Total stockholders' equity |
50,549,053 |
33,402,176 |
Total liabilities and stockholders'
equity |
$ 55,502,421 |
$ 118,291,046 |
CONTACT: Company Contact:
Pete A. Meyers
Chief Financial Officer and Treasurer
TetraLogic Pharmaceuticals Corporation
(610) 889-9900, x103
pete.meyers@tlog.com
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