- Announced Continuation of the ADAPT Trial
following Meeting with the FDA -
Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company
focused on the development and commercialization of individualized
immunotherapies based on the Arcelis® precision immunotherapy
technology platform, today reported financial results for the
second quarter ended June 30, 2017 and provided an update on the
Company’s recent corporate and operational highlights.
“Despite what has clearly been a challenging
period, Argos made substantial progress during the most recent
quarter,” stated Jeff Abbey, CEO of Argos Therapeutics. “First, we
were pleased to have a constructive meeting with the FDA, which
agreed with our decision to continue the Phase 3 ADAPT trial of
Rocapuldencel-T for the treatment of metastatic renal cell
carcinoma until we reach 290 events, the pre-specified number of
events at which the analysis of overall survival, the primary
endpoint, is to be conducted. We are grateful to our investigators
and patients for their continued support of our efforts, and we
look forward to our next planned analysis at 290 events, which we
expect to occur during the first half of 2018.”
“In addition, we are preparing a protocol
amendment and a revised statistical analysis plan seeking to extend
the final data analysis beyond 290 events, which the FDA has agreed
to review. We believe that this extension would enable us to better
account for the potential delayed treatment effect of
Rocapuldencel-T. Also of note, Robert Figlin, MD, Professor and
Chairman, Division of Hematology and Oncology at Cedars Sinai
Medical Center, co-principal investigator of the ADAPT trial, will
provide an overview of interim data from the ADAPT trial in an oral
presentation at the European Society of Medical Oncology (ESMO)
annual meeting to be held September 8 – 12 in Madrid.”
“Second, we were pleased to report positive
immunogenicity data in our development program for AGS-004 for the
treatment of HIV, which is funded by the NIH and the NIAID. We look
forward to results from the current trial, which is being conducted
at the University of North Carolina, to assess the potential
ability of AGS-004, in combination with vorinostat, a
latency-reversing agent, to eradicate the HIV virus in adult
patients. Despite several effective therapies for HIV, there is
currently no agent capable of eradicating the virus.”
“Finally, we were pleased to complete a $6.0
million secured convertible note financing with our collaborator
and largest shareholder, Pharmstandard. In addition, we took
significant steps during the quarter to reduce our expense
structure, including a substantial reduction of our workforce.
These measures, coupled with proceeds we have recently raised
through our at-the-market issuance facility, have enabled us to
extend our operational runway. ”
Second Quarter 2017 and Recent
Operational Highlights:
- In May 2017, the Company reported that the FDA agreed with the
Company's plan to continue the ADAPT trial until the Company
reaches 290 events, the pre-specified number of events at which the
analysis of overall survival, the primary endpoint, is to be
conducted, and that the FDA agreed to review a protocol amendment
and revised statistical analysis plan that would extend the trial
beyond the originally planned 290 events, which the Company
believes could enhance its ability to detect whether
Rocapuldencel-T has a delayed treatment effect
- In June 2017, the Company announced the closing of a $6.0
million secured convertible note financing with Pharmstandard
- In July 2017, the Company reported positive immunogenicity data
in its AGS-004 dendritic cell therapy program for the treatment of
adult patients with acute HIV infection
Selected Second Quarter 2017 Financial
Results
Revenue for the three months ended June 30, 2017
was $70,000 compared to $489,000 for the same period in 2016. The
decrease in revenue for the second quarter of 2017 compared with
the second quarter of 2016 resulted from lower reimbursement under
the Company’s contract with the NIH and NIAID primarily related to
the achievement of certain specified development milestones under
the Company’s AGS-004 program during 2016.
Research and development expense for the three
months ended June 30, 2017 was $5.1 million compared to $9.2
million for the same period in 2016. The decrease in research and
development expense for the second quarter of 2017 compared with
the second quarter of 2016 was primarily due to the Company’s
decision to significantly reduce the size of its workforce engaged
in research and development activities following the recommendation
of the IDMC to discontinue the ADAPT trial.
General and administrative expense for the three
months ended June 30, 2017 was $2.7 million compared to $3.4
million for the same period in 2016. The decrease in general and
administrative expense for the second quarter of 2017 compared with
the second quarter of 2016 was primarily due to reduced consulting
and personnel costs.
Reflecting the factors noted above, net loss for
the three months ended June 30, 2017 was $8.5 million compared to a
net loss of $12.6 million for the same period in 2016.
Revenue for the six months ended June 30, 2017
was $175,000 compared to $635,000 for the same period in 2016. The
decrease in revenue for the first half of 2017 compared with the
first half of 2016 resulted from lower reimbursement under the
Company’s contract with the NIH and NIAID primarily related to the
achievement of certain specified development milestones under the
Company’s AGS-004 program during 2016.
Research and development expense for the six
months ended June 30, 2017 was $13.0 million compared to $18.7
million for the same period in 2016. The decrease in research and
development expense for the first half of 2017 compared with the
first half of 2016 was primarily due to reduced expenses associated
with the Phase 3 ADAPT trial and the Company’s decision to
significantly reduce the size of its workforce engaged in research
and development activities following the recommendation of the IDMC
to discontinue the ADAPT trial.
General and administrative expense for the six
months ended June 30, 2017 was $6.6 million compared to $6.4
million for the same period in 2016. The increase in general and
administrative expense for the first half of 2017 compared with the
first half of 2016 was primarily due to increased personnel
costs.
Additionally, the Company incurred impairment
charges of $27.2 million and restructuring charges of $5.4 million
during the six months ended June 30, 2017 related to the Company’s
decision to discontinue preparation for commercial manufacturing
and reduce the size of its workforce, which amounts were partially
offset by a non-cash gain due to the decrease in the value of the
warrant liability of $20.2 million.
Reflecting the factors noted above, net loss for
the six months ended June 30, 2017 was $32.6 million compared to a
net loss of $25.4 million for the same period in 2016.
As of June 30, 2017, cash and cash equivalents
totaled $9.3 million.
About Argos TherapeuticsArgos
Therapeutics is an immuno-oncology company focused on the
development and commercialization of individualized immunotherapies
for the treatment of cancer and infectious diseases using its
Arcelis® technology platform. Argos' most advanced product
candidate, Rocapuldencel-T, is being evaluated in the ADAPT Phase 3
clinical trial for the treatment of metastatic renal cell carcinoma
(mRCC). In addition, Rocapuldencel-T is being studied in a Phase 2
investigator-initiated clinical trial as neoadjuvant therapy for
renal cell carcinoma (RCC). Argos is also developing a separate
Arcelis®-based product candidate, AGS-004, for the treatment of
human immunodeficiency virus (HIV), which is currently being
evaluated in combination with vorinostat, a latency-reversing drug,
in an investigator-initiated Phase 2 clinical trial aimed at HIV
eradication in adult patients. Funding for the development of
AGS-004 has been provided by the National Institutes of Health, the
National Institute of Allergy and Infectious Diseases, and the
Collaboratory of Research for AIDS Eradication.
Forward Looking StatementsAny
statements in this press release about Argos' future expectations,
plans and prospects, including statements about Argos’ financial
prospects, future operations and sufficiency of funds for future
operations, clinical development of Argos’ product candidates,
expectations regarding future clinical trials and FDA activities
and future expectations and plans and prospects for Argos and other
statements containing the words "believes," "anticipates,"
"estimates," "expects," "intends," "plans," "predicts," "projects,"
"targets," "may," "potential," "will," "would," "could," "should,"
"continue," and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors, including whether Argos' cash resources
will be sufficient to fund its continuing operations for the period
anticipated; whether preliminary or interim clinical data will be
indicative of the final data from a clinical trial; whether results
obtained in clinical trials will be indicative of results obtained
in future clinical trials; whether Argos' product candidates will
advance through the clinical trial process on a timely basis;
whether the results of such trials will warrant submission for
approval from the United States Food and Drug Administration or
equivalent foreign regulatory agencies; whether Argos' product
candidates will receive approval from regulatory agencies on a
timely basis or at all; whether, if product candidates obtain
approval, they will be successfully distributed and marketed;
whether Argos can successfully establish commercial manufacturing
operations on a timely basis or at all; and other factors discussed
in the "Risk Factors" section of Argos' Form 10-Q for the quarter
ended June 30, 2017, which is on file with the SEC, and in other
filings Argos makes with the SEC from time to time. In addition,
the forward-looking statements included in this press release
represent Argos' views as of the date hereof. Argos anticipates
that subsequent events and developments will cause Argos' views to
change. However, while Argos may elect to update these
forward-looking statements at some point in the future, Argos
specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as
representing Argos' views as of any date subsequent to the date
hereof.
|
ARGOS THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
|
|
Three Months Ended |
Six Months Ended |
|
June 30, |
June 30, |
|
2017 |
|
2016 |
2017 |
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
$ |
69,693 |
|
|
$ |
488,643 |
|
$ |
174,952 |
|
$ |
635,072 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
Research
and development |
|
5,120,952 |
|
|
|
9,164,184 |
|
|
13,034,781 |
|
|
18,666,160 |
|
General
and administrative |
|
2,679,867 |
|
|
|
3,389,479 |
|
|
6,642,758 |
|
|
6,364,503 |
|
Impairment of property and equipment |
|
— |
|
|
|
— |
|
|
27,204,349 |
|
|
— |
|
Restructuring costs |
|
344,474 |
|
|
|
— |
|
|
5,352,766 |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating expenses |
|
8,145,293 |
|
|
|
12,553,663 |
|
|
52,234,654 |
|
|
25,030,663 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(8,075,600 |
) |
|
|
(12,065,020 |
) |
|
(52,059,702 |
) |
|
(24,395,591 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
8,881 |
|
|
|
2,237 |
|
|
39,458 |
|
|
3,813 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense |
|
(294,329 |
) |
|
|
(543,462 |
) |
|
(1,022,760 |
) |
|
(1,034,655 |
) |
Gain on
early extinguishment of debt |
|
— |
|
|
|
— |
|
|
249,458 |
|
|
— |
|
Change in
fair value of warrant liability |
|
(177,563 |
) |
|
|
— |
|
|
20,179,761 |
|
|
— |
|
Other
expense |
|
— |
|
|
|
— |
|
|
(4,905 |
) |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
(8,538,611 |
) |
|
|
(12,606,245 |
) |
|
(32,618,690 |
) |
|
(25,426,433 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
$ |
(0.21 |
) |
|
$ |
(0.48 |
) |
$ |
(0.79 |
) |
$ |
(1.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding, basic and diluted |
|
41,374,852 |
|
|
|
26,066,160 |
|
|
41,344,356 |
|
|
24,336,393 |
|
ARGOS THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
|
June 30, |
|
December 31, |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
Current assets |
|
|
Cash and
cash equivalents |
$ |
9,337,084 |
|
|
$ |
52,973,376 |
Restricted cash |
|
740,000 |
|
|
|
— |
Assets
held for sale |
|
10,341,529 |
|
|
|
1,452,172 |
Prepaid
expenses and other current assets |
|
1,473,666 |
|
|
|
1,076,246 |
|
|
|
|
|
|
|
|
|
Total
current assets |
|
21,892,279 |
|
|
|
55,501,794 |
Property and equipment,
net |
|
4,054,990 |
|
|
|
40,951,577 |
Restricted
cash |
|
— |
|
|
|
740,000 |
Other assets |
|
11,020 |
|
|
|
11,020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets |
$ |
25,958,289 |
|
|
$ |
97,204,391 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders’ (Deficit) Equity |
|
|
Current
liabilities |
|
|
Accounts
payable |
$ |
794,278 |
|
|
$ |
5,377,377 |
Accrued
expenses |
|
7,385,997 |
|
|
|
9,980,891 |
Current
portion of restructuring obligation |
|
292,951 |
|
|
|
— |
Current
portion of notes payable |
|
17,871 |
|
|
|
11,475,480 |
Current
portion of manufacturing research and development obligation |
|
5,273,458 |
|
|
|
3,653,203 |
Current
portion of facility and capital lease obligations |
|
719,067 |
|
|
|
122,887 |
|
|
|
|
|
|
|
|
|
Total
current liabilities |
|
14,483,622 |
|
|
|
30,609,838 |
Convertible note
payable to related party |
|
6,015,616 |
|
|
|
— |
Long-term portion of
notes payable |
|
6,579,596 |
|
|
|
18,673,298 |
Long-term portion of
manufacturing research and development obligation |
|
3,070,463 |
|
|
|
4,509,033 |
Long-term portion of
facility and capital lease obligations |
|
8,967,426 |
|
|
|
9,592,966 |
Deferred
liabilities |
|
6,668,500 |
|
|
|
6,723,500 |
Warrants |
|
746,300 |
|
|
|
20,926,061 |
Total stockholders’
(deficit) equity |
|
(20,573,234 |
) |
|
|
6,169,695 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders’ (deficit) equity |
$ |
25,958,289 |
|
|
$ |
97,204,391 |
Media and investor contact:
Richard Katz, MD, MBA
Chief Financial Officer
Argos Therapeutics, Inc.
919-287-6315
rkatz@argostherapeutics.com