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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Anthera Pharmaceuticals Inc (CE) | USOTC:ANTH | OTCMarkets | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.000001 | 0.00 | 01:00:00 |
☒
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
20-1852016
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
(I.R.S. Employer
Identification No.)
|
|
|
25801 Industrial Boulevard, Suite B
Hayward, California
(Address of Principal Executive Offices)
|
94545
(Zip Code)
|
Title of Each Class
|
|
Name of Each Exchange on Which Registered
|
Common Stock, par value $0.001 per share
|
|
The NASDAQ Global Market
|
Large accelerated filer ☐
|
Accelerated filer☒
|
Non-accelerated filer ☐
(Do not check if a smaller reporting company)
|
Smaller reporting company ☐
|
|
|
Page
|
|
PART I
|
|
5
|
||
25
|
||
42
|
||
42
|
||
42
|
||
42
|
||
|
PART II
|
|
43
|
||
44
|
||
45
|
||
57
|
||
57
|
||
57
|
||
57
|
||
58
|
||
|
PART III
|
|
59
|
||
59
|
||
59
|
||
59
|
||
59
|
||
|
PART IV
|
|
60
|
||
91 | ||
|
• |
the progress of, timing of and amount of expenses associated with our research, development and commercialization activities;
|
• |
the
timing
, conduct and success of our clinical studies for our product candidates;
|
• |
our
ability
to obtain U.S. and foreign regulatory approval for our product candidates and the ability of our product candidates to meet existing or future regulatory standards;
|
• |
our
expectations
regarding federal, state and foreign regulatory requirements;
|
• |
the
therapeutic
benefits and effectiveness of our product candidates;
|
• |
the
accuracy
of our estimates of the size and characteristics of the markets that may be addressed by our product candidates;
|
• |
our ability to manufacture sufficient amounts of our product candidates for clinical studies and products for
commercialization
activities;
|
• |
our
intention
to seek to establish strategic collaborations or partnerships for the development or sale of our product candidates;
|
• |
our expectations as to future financial performance, expense levels and liquidity sources;
|
• |
the timing of commercializing our product candidates;
|
• |
our ability to compete with other companies that are or may be developing or selling products that are competitive with our product candidates;
|
• |
anticipated trends and challenges in our potential markets;
|
• |
our ability to attract and retain key personnel; and
|
• |
other factors discussed elsewhere in this report.
|
· |
use of biotechnology-derived high-purity enzymes that are produced by fermentation processes rather than from mammalian organs which carry a label warning for viral transmission;
|
· |
use of a novel chemically modified lipase drug substance that provides resistance to degradation at gastric pH;
|
· |
a formulation containing a ratio of the three digestive enzymes (lipase, protease and amylase) that closely matches the naturally-occurring enzyme ratio in humans;
|
· |
A product that is wholly non-porcine. The enzymes and excipients are non-porcine, and the capsule meets all of the specifications for halal;
|
· |
a capsule formulation using known, safe, excipients that provides lower pill burden and good delivery performance. The pure, high-activity enzyme constituents, and absence of bulky enteric coating give rise to smaller, easy-to-swallow capsules with good disintegration once swallowed, and adequate storage stability compared with porcine PERTs of an equivalent lipase unit dose strength; and
|
· |
a sachet formulation containing Sollpura power for oral solution which can be easily dissolved into water, and finally provides patients, especially young pediatric patients, with an easy-to-swallow dosing option.
|
• |
obtain and maintain patent and other proprietary protection for the technology, inventions and improvements we consider important to our business;
|
• |
defend our patents;
|
• |
preserve the confidentiality of our trade secrets; and
|
• |
operate our business without infringing the patents and proprietary rights of third parties.
|
• |
Two issued U.S. patents;
|
• |
Four issued European (EP) patents, each validated in one or more of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Monaco, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey;
|
• |
14 issued non-EP foreign patents in Australia, Canada, China, Hong Kong, India, Israel, Japan, Mexico, Russia, South Korea and Ukraine; and
|
• |
Three pending non-EP foreign patent application.
|
• |
Four issued U.S. patents;
|
• |
One pending U.S. non-provisional patent application;
|
• |
Three issued European (EP) patents, each validated in one or more of Albania, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Monaco, the Netherlands, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom;
|
• |
One pending EP patent application;
|
• |
23 issued non-EP foreign patents in Australia, Bulgaria, Canada, China, the Czech Republic, Estonia, Eurasia (validated in all nine Eurasian countries), Hong Kong, Hungary, Israel, Japan, Mexico, New Zealand, Norway, the Philippines, Poland, Serbia, Singapore, Slovakia, South Korea and South Africa; and
|
• |
Four pending non-EP foreign patent applications in Brazil, Hong Kong, Mexico, and Poland.
|
• |
completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices regulations;
|
• |
submission to the FDA of an IND, which must become effective before human clinical studies may begin;
|
• |
performance of adequate and well-controlled human clinical studies according to Good Clinical Practices, or GCP, to establish the safety and efficacy of the proposed drug or biological product for its intended use;
|
• |
submission to the FDA of an NDA for a new drug or BLA for a biological product;
|
• |
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug or biological product is produced to assess compliance with cGMP; and
|
• |
FDA review and approval of the NDA or BLA.
|
• |
Phase 1.
The product is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
|
• |
Phase 2.
Involves studies in a limited patient population to identify possible adverse effects and safety risks to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage and schedule.
|
• |
Phase 3.
Clinical studies are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These studies are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling.
|
· |
obtain favorable results for and advance the development of Sollpura, our product candidate for the treatment of patients with low digestive enzyme levels and potentially other diseases;
|
· |
obtain favorable results for and advance the development of blisibimod, our product candidate for the treatment of B-cell mediated autoimmune diseases, including successfully launching and completing clinical studies in patients with IgA nephropathy, or other indications related to the development of blisibimod;
|
· |
obtain regulatory approval for Sollpura and blisibimod;
|
· |
if regulatory approvals are obtained, begin the commercial manufacturing of our product candidates with third-party manufacturers;
|
· |
launch commercial sales and effectively market our product candidates, either independently or in strategic collaborations with third parties; and
|
· |
achieve broad market acceptance of our product candidates in the medical community and with third-party payors.
|
· |
the scope, size, rate of progress, results and costs of our clinical studies and other development activities for our product candidates;
|
· |
manufacturing campaign for Sollpura and blisibimod clinical materials, including formulation development and product enhancement;
|
· |
non-clinical activities that we may pursue parallel to our clinical studies;
|
· |
the cost, timing and outcomes of regulatory proceedings;
|
· |
payments received under any strategic collaborations;
|
· |
the filing, prosecution and enforcement of patent claims;
|
· |
the costs associated with commercializing our product candidates if they receive regulatory approval, including the cost and timing of developing sales and marketing capabilities, or entering into strategic collaboration with others relating to the commercialization of our product candidates; and
|
· |
revenues received from approved products, if any, in the future
|
· |
terminate, reduce or delay clinical studies or other development activities for our product candidates; or;
|
· |
terminate, reduce or delay our (i) establishment of sales and marketing capabilities, (ii) pursuit of strategic collaborations with others relating to the sales, marketing and commercialization of our product candidates or (iii) other activities that may be necessary to commercialize our product candidates, if approved for sale.
|
· |
offer therapeutic or other improvement over existing, comparable therapeutics;
|
· |
be proven safe and effective in clinical studies;
|
· |
meet applicable regulatory standards;
|
· |
be capable of being produced in sufficient quantities at acceptable costs;
|
· |
be successfully commercialized; or
|
· |
obtain favorable reimbursement.
|
· |
obtaining regulatory approval to commence a clinical study or complying with conditions imposed by a regulatory authority regarding the scope or design of a clinical study;
|
· |
reaching agreement on acceptable terms with prospective clinical research organizations, or CROs, and study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and study sites;
|
· |
manufacturing, including manufacturing sufficient quantities of product candidates or other materials for use in clinical studies;
|
· |
obtaining IRB, approval or the approval of other reviewing entities to conduct a clinical study at prospective sites;
|
· |
recruiting and enrolling patients to participate in clinical studies for a variety of reasons, including size of patient population, nature of clinical study protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical study programs for similar indications;
|
· |
severe or unexpected drug-related adverse effects experienced by patients in a clinical study; and
|
· |
retaining patients who have initiated a clinical study, but may withdraw due to treatment protocol, adverse effects from the therapy, lack of efficacy from the treatment, personal issues or who are lost to further follow-up.
|
· |
failure to conduct the clinical study in accordance with regulatory requirements or our clinical protocols;
|
· |
inspection of the clinical study operations or study sites by the U.S. FDA or other regulatory authorities resulting in the imposition of a clinical hold;
|
· |
unforeseen safety issues or any determination that a clinical study presents unacceptable health risks; and
|
· |
lack of adequate funding to continue the clinical study, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional clinical studies and increased expenses associated with the services of our CROs and other third parties.
|
• |
regulatory authorities may withdraw their approval of the products;
|
• |
regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;
|
• |
we may be required to change the way the products are administered, conduct additional clinical studies or change the labeling of the products;
|
• |
we could be sued and held liable for harm caused to patients; and
|
• |
our reputation may suffer.
|
• |
issue warning letters or untitled letters;
|
• |
seek an injunction or impose civil or criminal penalties or monetary fines;
|
• |
suspend or withdraw regulatory approval;
|
• |
suspend any ongoing clinical studies;
|
• |
refuse to approve pending applications or supplements to applications filed by us;
|
• |
suspend or impose restrictions on operations, including costly new manufacturing requirements; or
|
• |
seize or detain products, refuse to permit the import or export of products, or require us to initiate a product recall.
|
• |
demonstration of clinical safety and efficacy compared to other products;
|
• |
the relative convenience, ease of administration and acceptance by physicians and payors of our product candidates;
|
• |
the prevalence and severity of any adverse effects;
|
• |
limitations or warnings contained in a product’s U.S. FDA-approved labeling;
|
• |
availability of alternative treatments;
|
• |
pricing and cost-effectiveness;
|
• |
the effectiveness of our or any future collaborators’ sales and marketing strategies;
|
• |
our ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid; and
|
• |
the willingness of patients to pay out-of-pocket in the absence of third-party coverage.
|
• |
impairment of our business reputation;
|
• |
withdrawal of clinical study participants;
|
• |
costs of related litigation;
|
• |
distraction of management’s attention from our primary business;
|
• |
substantial monetary awards to patients or other claimants;
|
• |
the inability to commercialize product candidates; and
|
• |
decreased demand for product candidates, if approved for commercial sale.
|
· |
make a special written suitability determination for the purchaser
;
|
· |
receive the purchaser’s written agreement to the transaction prior to sale
;
|
· |
provide the purchaser with risk disclosure documents which identify certain risks associated with investing in “penny stocks” and which describe the market for these “penny stocks” as well as a purchaser’s legal remedies; and
|
· |
obtain a signed and dated acknowledgement from the purchaser demonstrating that the purchaser has actually received the required risk disclosure document before a transaction in a “penny stock” can be completed.
|
· |
plans for, progress in and results from clinical studies for our product candidates;
|
· |
announcements of new products, services or technologies, commercial relationships, acquisitions or other events by us or our competitors;
|
· |
developments concerning proprietary rights, including those pertaining to patents patent applications held by our licensors;
|
· |
failure of any of our product candidates, if approved, to achieve commercial success;
|
· |
fluctuations in stock market prices and trading volumes of securities of similar companies;
|
· |
general market conditions and overall fluctuations in U.S. equity markets;
|
· |
variations in our operating results, or the operating results of our competitors;
|
· |
changes in our financial guidance or securities analysts’ estimates of our financial performance;
|
· |
changes in accounting principles;
|
· |
sales of large blocks of our common stock, including sales by our executive officers, directors and significant stockholders;
|
· |
publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts;
|
· |
additions or departures of any of our key personnel;
|
· |
announcements related to litigation;
|
· |
changing legal or regulatory developments in the United States and other countries;
|
· |
delisting from the NASDAQ Global Market; and
|
· |
discussion of us or our stock price by the financial press and in online investor communities.
|
· |
a classified and staggered board of directors whose members can only be dismissed for cause;
|
· |
the prohibition on actions by written consent of our stockholders;
|
· |
the limitation on who may call a special meeting of stockholders;
|
· |
the establishment of advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon at stockholder meetings;
|
· |
the ability of our board of directors to issue preferred stock without stockholder approval, which would increase the number of outstanding shares and could thwart a takeover attempt; and
|
· |
the requirement of at least 75% of the outstanding common stock to amend any of the foregoing provisions.
|
• |
we or our licensors were the first to make the inventions covered by each of our pending patent applications;
|
• |
we or our licensors were the first to file patent applications for these inventions;
|
• |
others will not independently develop similar or alternative technologies or duplicate any of our technologies;
|
• |
any of our or our licensors’ pending patent applications will result in issued patents;
|
• |
any of our or our licensors’ patents will be valid or enforceable;
|
• |
any patents issued to us or our licensors and collaborators will provide a basis for commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties;
|
• |
we will develop additional proprietary technologies or product candidates that are patentable; or
|
• |
the patents of others will not have an adverse effect on our business.
|
|
High
|
Low
|
||||||
First Quarter 2015
|
$
|
6.37
|
$
|
1.59
|
||||
Second Quarter 2015
|
$
|
9.89
|
$
|
4.05
|
||||
Third Quarter 2015
|
$
|
11.65
|
$
|
5.80
|
||||
Fourth Quarter 2015
|
$
|
7.15
|
$
|
4.25
|
||||
First Quarter 2016
|
$
|
4.90
|
$
|
2.28
|
||||
Second Quarter 2016
|
$
|
4.40
|
$
|
2.69
|
||||
Third Quarter 2016
|
$
|
4.00
|
$
|
2.80
|
||||
Fourth Quarter 2016
|
$
|
3.42
|
$
|
0.64
|
Year Ended December 31,
|
||||||||||||||||||||
2016
|
2015
|
2014
|
2013
|
2012
|
||||||||||||||||
(in thousands, except share and per share data)
|
||||||||||||||||||||
Statement of Operations Data:
|
||||||||||||||||||||
Revenues
|
||||||||||||||||||||
License revenue
|
$
|
139
|
$
|
2,562
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||
Collaborative revenue
|
6
|
623
|
—
|
—
|
—
|
|||||||||||||||
Total revenues
|
145
|
3,185
|
—
|
—
|
—
|
|||||||||||||||
Operating expenses
|
||||||||||||||||||||
Research and development
|
$
|
46,512
|
$
|
33,498
|
$
|
21,839
|
$
|
21,684
|
$
|
49,219
|
||||||||||
General and administrative
|
11,071
|
7,568
|
6,620
|
6,563
|
6,715
|
|||||||||||||||
Research award (1)
|
(261
|
)
|
(2,638
|
)
|
—
|
—
|
—
|
|||||||||||||
Total operating expenses
|
57,322
|
38,428
|
28,459
|
28,247
|
55,934
|
|||||||||||||||
Loss from operations
|
(57,177
|
)
|
(35,243
|
)
|
(28,459
|
)
|
(28,247
|
)
|
(55,934
|
)
|
||||||||||
Other income (expense)
|
||||||||||||||||||||
Other income (expense)
|
(90
|
)
|
23
|
(96
|
)
|
(15
|
)
|
(111
|
)
|
|||||||||||
Interest expense
|
—
|
—
|
(1,049
|
)
|
(2,599
|
)
|
(3,354
|
)
|
||||||||||||
Change in fair value of warrant liability
|
1,744
|
—
|
—
|
—
|
—
|
|||||||||||||||
Mark-to-market adjustment of warrant liability
|
—
|
—
|
—
|
—
|
14,070
|
|||||||||||||||
Total other income (expense)
|
1,654
|
23
|
(1,145
|
)
|
(2,614
|
)
|
10,605
|
|||||||||||||
Net loss
|
$
|
(55,523
|
)
|
$
|
(35,220
|
)
|
$
|
(29,604
|
)
|
$
|
(30,861
|
)
|
$
|
(45,329
|
)
|
|||||
Deemed dividends attributable to preferred stock
|
(10,914
|
)
|
—
|
—
|
—
|
—
|
||||||||||||||
Net loss applicable to common stockholders
|
(66,437
|
)
|
$
|
(35,220
|
)
|
$
|
(29,604
|
)
|
$
|
(30,861
|
)
|
$
|
(45,329
|
)
|
||||||
Net loss per share — basic and diluted (2)
|
$
|
(1.61
|
)
|
$
|
(0.99
|
)
|
$
|
(1.36
|
)
|
$
|
(1.69
|
)
|
$
|
(6.27
|
)
|
|||||
Weighted average shares used in net loss per share -- basic and
diluted (3) |
41,310,269
|
35,631,237
|
21,776,269
|
18,267,413
|
7,225,406
|
December 31,
|
||||||||||||||||||||
2016
|
2015
|
2014
|
2013
|
2012
|
||||||||||||||||
(in thousands)
|
||||||||||||||||||||
Balance Sheet Data:
|
||||||||||||||||||||
Cash, cash equivalents and short-term investments
|
$
|
20,843
|
$
|
46,951
|
$
|
2,639
|
$
|
25,946
|
$
|
24,753
|
||||||||||
Restricted cash
|
—
|
—
|
—
|
10,000
|
—
|
|||||||||||||||
Working capital
|
12,084
|
39,394
|
(2,729
|
)
|
18,743
|
6,429
|
||||||||||||||
Total assets
|
23,471
|
48,125
|
3,490
|
37,417
|
26,445
|
|||||||||||||||
Total notes payable
|
—
|
—
|
—
|
17,875
|
20,550
|
|||||||||||||||
Total liabilities
|
10,624
|
8,468
|
5,751
|
22,659
|
29,971
|
|||||||||||||||
Contingently redeemable & convertible preferred stock
|
377
|
—
|
—
|
—
|
—
|
|||||||||||||||
Convertible preferred stock
|
8,614
|
—
|
—
|
—
|
—
|
|||||||||||||||
Common stock and additional paid-in capital
|
411,410
|
391,688
|
314,550
|
301,965
|
252,827
|
|||||||||||||||
Accumulated deficit
|
(407,554
|
)
|
(352,031
|
)
|
(316,811
|
)
|
(287,207
|
)
|
(256,346
|
)
|
||||||||||
Total stockholders’ equity (deficit)
|
12,470
|
39,657
|
(2,261
|
)
|
14,758
|
(3,526
|
)
|
(1) |
In March 2015, we received a research award of up to $3 million from CFFT for our development of Sollpura. For the year ended December 31, 2016, we recognized $0.3 million in research award from CFFT in connection with achieving certain milestones specified in the award agreement. The amount has been recognized as a component of Operating Expenses.
|
(2) |
Diluted earnings per share, or EPS, is identical to basic EPS since common equivalent shares are excluded from the calculation, as their effect is anti-dilutive.
|
(3) |
Weighted average shares used in net loss per basic and diluted share in 2012 have been adjusted to reflect a 1-for-8 reverse stock split effectuated by the Company on July 15, 2013.
|
• |
Use of biotechnology-derived high-purity enzymes that are produced by fermentation processes rather than from mammalian organs which carry a label warning for viral transmission;
|
• |
use of a novel chemically modified lipase drug substance that provides resistance to degradation at gastric pH;
|
• |
a formulation containing a ratio of the three digestive enzymes (lipase, protease and amylase) that closely matches the naturally-occurring enzyme ratio in humans;
|
· |
A product that is wholly non-porcine. The enzymes and excipients are non-porcine, and the capsule meets all of the specifications for kosher and halal;
|
• |
a capsule formulation using known, safe, excipients that provides lower pill burden and good delivery performance. The pure, high-activity enzyme constituents, and absence of bulky enteric coating give rise to smaller, easy-to-swallow capsules with good disintegration once swallowed, and adequate storage stability compared with porcine PERTs of an equivalent lipase unit dose strength; and
|
• |
a sachet formulation containing Sollpura power for oral solution which can be easily dissolved into water, and finally provides patients, especially young pediatric patients, with an easy-to-swallow dosing option.
|
|
Year Ended December 31,
|
|||||||||||
|
2016
|
2015
|
2014
|
|||||||||
Allocated costs:
|
||||||||||||
Blisibimod (1) (2)
|
$
|
13,222
|
$
|
21,082
|
$
|
17,806
|
||||||
Sollpura
|
26,113
|
6,682
|
464
|
|||||||||
Varespladib (3)
|
—
|
—
|
(464
|
)
|
||||||||
Unallocated costs
|
7,177
|
5,734
|
4,033
|
|||||||||
Total research and development expense
|
$
|
46,512
|
$
|
33,498
|
$
|
21,839
|
(1) |
During the year ended December 31, 2015, Blisibimod expense included reimbursed development costs totaling $1.5 million pursuant to the Zenyaku Agreement.
|
(2) |
During the year ended December 31, 2014, Blisibimod expense included non-cash license fee $1.0 million in connection with an amendment to the Amgen Agreement.
|
(3) |
During the year ended December 31, 2014, Varespladib expense included a refund of $0.5 million from a vendor for our VISTA-16 clinical study. All development efforts for Varespladib were terminated in 2012.
|
• |
the number of sites included in the studies;
|
• |
the length of time required to enroll suitable patient subjects;
|
• |
the number of patients that participate in the studies;
|
• |
the number of doses that patients receive;
|
• |
the drop-out or discontinuation rates of patients; and
|
• |
the duration of patient follow-up.
|
• |
fees paid to CROs in connection with clinical studies;
|
• |
fees paid to investigative sites in connection with clinical studies;
|
• |
fees paid to contract manufacturers in connection with the production of clinical study materials; and
|
• |
fees paid to vendors in connection with preclinical development activities.
|
|
2016
|
2015
|
$ Change
|
% Change
|
||||||||||||
License revenue
|
$
|
139
|
$
|
2,562
|
$
|
(2,423
|
)
|
(95
|
)%
|
|||||||
Collaborative revenue
|
6
|
623
|
(617
|
)
|
(99
|
)%
|
||||||||||
Total revenues
|
$
|
145
|
$
|
3,185
|
$
|
(3,040
|
)
|
(96
|
)%
|
|
2016
|
2015
|
$ Change
|
% Change
|
||||||||||||
Research and development expense
|
$
|
46,512
|
$
|
33,498
|
$
|
13,014
|
39
|
%
|
|
2016
|
2015
|
$ Change
|
% Change
|
||||||||||||
General and administrative expenses
|
$
|
11,071
|
$
|
7,568
|
$
|
3,503
|
47
|
%
|
|
2016
|
2015
|
$ Change
|
% Change
|
||||||||||||
Research Award
|
$
|
(261
|
)
|
$
|
(2,638
|
)
|
$
|
(2,377
|
)
|
(91
|
)%
|
|
2016
|
2015
|
$ Change
|
% Change
|
||||||||||||
Other income (expense)
|
$
|
(90
|
)
|
$
|
23
|
$
|
(113
|
)
|
(492
|
)%
|
||||||
Change in fair value of warrant liability
|
1,744
|
—
|
1,744
|
100
|
%
|
|||||||||||
Total other income (expense)
|
$
|
1,654
|
$
|
23
|
$
|
1,631
|
7,092
|
%
|
|
2015
|
2014
|
$ Change
|
% Change
|
||||||||||||
License revenue
|
$
|
2,562
|
$
|
—
|
$
|
2,562
|
100
|
%
|
||||||||
Collaborative revenue
|
623
|
—
|
623
|
100
|
%
|
|||||||||||
Total revenues
|
$
|
3,185
|
$
|
—
|
$
|
3,185
|
100
|
%
|
|
2015
|
2014
|
$ Change
|
% Change
|
||||||||||||
Research and development expense
|
$
|
33,498
|
$
|
21,839
|
$
|
11,659
|
53
|
%
|
|
2015
|
2014
|
$ Change
|
% Change
|
||||||||||||
General and administrative expenses
|
$
|
7,568
|
$
|
6,620
|
$
|
948
|
14
|
%
|
|
2015
|
2014
|
$ Change
|
% Change
|
||||||||||||
Research Award
|
$
|
(2,638
|
)
|
$
|
—
|
$
|
(2,638
|
)
|
(100
|
)%
|
|
2015
|
2014
|
$ Change
|
% Change
|
||||||||||||
Other expense
|
$
|
23
|
$
|
(96
|
)
|
$
|
119
|
124
|
%
|
|||||||
Interest expense
|
—
|
(1,049
|
)
|
1,049
|
100
|
%
|
||||||||||
Total Other income (expense)
|
$
|
23
|
$
|
(1,145
|
)
|
$
|
1,168
|
102
|
%
|
|
2016
|
2015
|
||||||
Net cash used in operating activities
|
$
|
(48,919
|
)
|
$
|
(30,907
|
)
|
||
Net cash used in investing activities
|
(766
|
)
|
(80
|
)
|
||||
Net cash provided by financing activities
|
23,577
|
75,299
|
||||||
Net increase (decrease) in cash and cash equivalents
|
$
|
(26,108
|
)
|
$
|
44,312
|
|
2015
|
2014
|
||||||
Net cash used in operating activities
|
$
|
(30,907
|
)
|
$
|
(25,601
|
)
|
||
Net cash provided by (used in) investing activities
|
(80
|
)
|
10,000
|
|||||
Net cash provided by (used in) financing activities
|
75,299
|
(7,706
|
)
|
|||||
Net increase (decrease) in cash and cash equivalents
|
$
|
44,312
|
$
|
(23,307
|
)
|
|
Payment Due by Period
|
|||||||||||||||||||
Contractual Obligations
|
< 1 year
|
1-3 years
|
3-5 years
|
> 5 years
|
Total
|
|||||||||||||||
Facility Leases
|
$
|
209
|
$
|
47
|
$
|
—
|
$
|
—
|
$
|
256
|
• |
continue clinical development of blisibimod;
|
• |
hire additional clinical, scientific and management personnel; and
|
• |
implement new operational, financial and management information systems.
|
• |
the progress of clinical studies of our product candidates;
|
• |
the time and costs involved in obtaining regulatory approvals;
|
• |
delays that may be caused by evolving requirements of regulatory agencies;
|
• |
the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims;
|
• |
our ability to establish, enforce and maintain selected strategic alliances; and
|
• |
the acquisition of technologies, product candidates and other business opportunities that require financial commitments.
|
(1) |
Index list to Consolidated Financial Statements:
|
|
Page
|
61
|
|
62
|
|
63
|
|
64
|
|
65
|
|
66
|
|
67
|
(2) |
Consolidated financial statement Schedules
|
(3) |
Exhibits
|
December 31,
|
||||||||
2016
|
2015
|
|||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
20,843
|
$
|
46,951
|
||||
Accounts receivable
|
—
|
326
|
||||||
Prepaid expenses and other current assets
|
1,865
|
585
|
||||||
Total current assets
|
22,708
|
47,862
|
||||||
Property and equipment — net
|
763
|
263
|
||||||
TOTAL
|
$
|
23,471
|
$
|
48,125
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
4,782
|
$
|
5,259
|
||||
Accrued clinical expenses
|
3,884
|
1,377
|
||||||
Accrued liabilities
|
113
|
98
|
||||||
Accrued payroll and related costs
|
1,845
|
1,596
|
||||||
Deferred revenue
|
—
|
138
|
||||||
Total current liabilities
|
10,624
|
8,468
|
||||||
Total liabilities
|
10,624
|
8,468
|
||||||
Commitments and Contingencies (Note 8)
|
||||||||
Contingently Redeemable Series X Convertible Preferred Stock, $0.001 par
value, 487 and 0 shares issued and outstanding as of December 31, 2016 and December 31, 2015, respectively |
||||||||
377
|
—
|
|||||||
Stockholders’ equity:
|
||||||||
Series X Convertible Preferred Stock, $0.001 par value, 5,000,000 shares
authorized; 9,012 and 0 shares issued and outstanding as of December 31, 2016 and December 31, 2015, respectively |
8,614
|
—
|
||||||
Common stock, $0.001 par value, 100,000,000 shares authorized; 45,964,286 and
40,004,037 shares issued and outstanding as of December 31, 2016 and December 31, 2015, respectively |
46
|
40
|
||||||
Additional paid-in capital
|
411,364
|
391,648
|
||||||
Accumulated deficit
|
(407,554
|
)
|
(352,031
|
)
|
||||
Total stockholders’ equity
|
12,470
|
39,657
|
||||||
TOTAL
|
$
|
23,471
|
$
|
48,125
|
|
Years ended December 31,
|
|||||||||||
|
2016
|
2015
|
2014
|
|||||||||
REVENUES:
|
||||||||||||
License revenue
|
$
|
139
|
$
|
2,562
|
$
|
—
|
||||||
Collaborative revenue
|
6
|
623
|
—
|
|||||||||
Total revenues
|
145
|
3,185
|
—
|
|||||||||
OPERATING EXPENSES:
|
||||||||||||
Research and development
|
$
|
46,512
|
$
|
33,498
|
$
|
21,839
|
||||||
General and administrative
|
11,071
|
7,568
|
6,620
|
|||||||||
Research award
|
(261
|
)
|
(2,638
|
)
|
—
|
|||||||
Total operating expenses
|
57,322
|
38,428
|
28,459
|
|||||||||
LOSS FROM OPERATIONS
|
(57,177
|
)
|
(35,243
|
)
|
(28,459
|
)
|
||||||
OTHER INCOME (EXPENSE):
|
||||||||||||
Other income (expense)
|
(90
|
)
|
23
|
(96
|
)
|
|||||||
Interest expense
|
—
|
—
|
(1,049
|
)
|
||||||||
Change in fair value of warrant liability
|
1,744
|
—
|
—
|
|||||||||
Total other income (expense)
|
1,654
|
23
|
(1,145
|
)
|
||||||||
|
||||||||||||
NET LOSS
|
$
|
(55,523
|
)
|
$
|
(35,220
|
)
|
$
|
(29,604
|
)
|
|||
Deemed dividends attributable to preferred stock
|
(10,914
|
)
|
—
|
—
|
||||||||
Net loss applicable to common stockholders
|
(66,437
|
)
|
$
|
(35,220
|
)
|
(29,604
|
)
|
|||||
Net loss per share applicable to common
stockholders —basic and diluted
|
$
|
(1.61
|
)
|
$
|
(0.99
|
)
|
$
|
(1.36
|
)
|
|||
Weighted-average number of shares used in
per share calculation—basic and diluted
|
41,310,269
|
35,631,237
|
21,776,269
|
|
Contingently Redeemable Series X Convertible Preferred Stock
|
Series X Convertible Preferred Stock
|
Common Stock
|
|||||||||||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Additional
Paid-In
Capital
|
Accumulated
Deficit
|
Total
Stockholders'
Equity
(Deficit)
|
|||||||||||||||||||||||||||
Balance at December 31, 2013
|
-
|
$
|
-
|
-
|
$
|
-
|
19,415,901
|
$
|
19
|
$
|
301,946
|
$
|
(287,207
|
)
|
$
|
14,758
|
||||||||||||||||||||
Issuance of common stock upon release of
restricted stock units |
-
|
-
|
-
|
-
|
66,704
|
1
|
195
|
-
|
196
|
|||||||||||||||||||||||||||
Issuance of common stock pursuant to exercise of
stock options and employee stock purchase plan |
-
|
-
|
-
|
-
|
27,000
|
-
|
37
|
-
|
37
|
|||||||||||||||||||||||||||
Issuance of common stock pursuant to an equity
purchase agreement, net of issuance cost of $7 |
-
|
-
|
-
|
-
|
512,626
|
-
|
1,301
|
-
|
1,301
|
|||||||||||||||||||||||||||
Issuance of common stock pursuant to an
at-the-market equity program, net of issuance cost of $354 |
-
|
-
|
-
|
-
|
2,982,978
|
3
|
9,047
|
-
|
9,050
|
|||||||||||||||||||||||||||
Share-based compensation related to equity awards
|
-
|
-
|
-
|
-
|
-
|
-
|
2,001
|
-
|
2,001
|
|||||||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(29,604
|
)
|
(29,604
|
)
|
|||||||||||||||||||||||||
Balance at December 31, 2014
|
-
|
$
|
-
|
-
|
$
|
-
|
23,005,209
|
$
|
23
|
$
|
314,527
|
$
|
(316,811
|
)
|
$
|
(2,261
|
)
|
|||||||||||||||||||
Issuance of common stock upon release of
restricted stock units |
-
|
-
|
-
|
-
|
515
|
-
|
3
|
-
|
3
|
|||||||||||||||||||||||||||
Issuance of common stock pursuant to exercise of
stock options and employee stock purchase plan |
-
|
-
|
-
|
-
|
140,662
|
-
|
410
|
-
|
410
|
|||||||||||||||||||||||||||
Issuance of common stock pursuant to an equity
purchase agreement, net of issuance cost of $60 |
-
|
-
|
-
|
-
|
59,338
|
-
|
75
|
-
|
75
|
|||||||||||||||||||||||||||
Issuance of common stock pursuant to an
at-the-market equity program, net of issuance cost of $379 |
-
|
-
|
-
|
-
|
3,208,529
|
3
|
12,055
|
-
|
12,058
|
|||||||||||||||||||||||||||
Issuance of common stock for cash at average
$5.62 per share, net of issuance cost of $3,744 |
-
|
-
|
-
|
-
|
10,222,223
|
10
|
53,746
|
-
|
53,756
|
|||||||||||||||||||||||||||
Issuance of common stock to Zenyaku Kogyo Co.,
Ltd. for cash |
-
|
-
|
-
|
-
|
2,946,810
|
3
|
6,297
|
-
|
6,300
|
|||||||||||||||||||||||||||
Issuance of common stock to Amgen to settle a
license fee obligation |
-
|
-
|
-
|
-
|
420,751
|
1
|
999
|
-
|
1,000
|
|||||||||||||||||||||||||||
Share-based compensation related to equity awards
|
-
|
-
|
-
|
-
|
-
|
-
|
3,536
|
-
|
3,536
|
|||||||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(35,220
|
)
|
(35,220
|
)
|
|||||||||||||||||||||||||
Balance at December 31, 2015
|
-
|
$
|
-
|
-
|
$
|
-
|
40,004,037
|
$
|
40
|
$
|
391,648
|
$
|
(352,031
|
)
|
$
|
39,657
|
||||||||||||||||||||
Issuance of common stock pursuant to exercise of
stock options and employee stock purchase plan |
-
|
-
|
-
|
-
|
135,275
|
-
|
304
|
-
|
304
|
|||||||||||||||||||||||||||
Share based compensation related to equity awards
|
-
|
-
|
-
|
-
|
-
|
-
|
6,880
|
-
|
6,880
|
|||||||||||||||||||||||||||
Issuance of common stock pursuant to an
at-the-market equity program, net of issuance costs of $277 |
-
|
-
|
-
|
-
|
1,500,985
|
2
|
4,848
|
-
|
4,850
|
|||||||||||||||||||||||||||
Issuance of common stock pursuant to an equity
purchase agreement, net of issuance costs of $87 |
-
|
-
|
-
|
-
|
514,829
|
-
|
1,579
|
-
|
1,579
|
|||||||||||||||||||||||||||
Issuance of Series X convertible preferred stock, net of
issuance costs of $156 |
17,000
|
16,844
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||||||||
Investors’ right to acquire future shares of Series X-1
convertible preferred stock |
-
|
(3,583
|
)
|
-
|
3,583
|
-
|
-
|
-
|
-
|
3,583
|
||||||||||||||||||||||||||
Reclassification of Series X convertible preferred
stock from temporary to permanent equity |
(16,513
|
)
|
(9,206
|
)
|
16,513
|
9,206
|
-
|
-
|
-
|
-
|
9,206
|
|||||||||||||||||||||||||
Conversion of Series X convertible preferred stock
into common stock |
-
|
(7,501
|
)
|
(5,456
|
)
|
3,809,160
|
4
|
5,452
|
-
|
-
|
||||||||||||||||||||||||||
Beneficial conversion feature on Series X convertible
preferred stock |
-
|
(8,831
|
)
|
(802
|
)
|
-
|
-
|
9,633
|
-
|
8,831
|
||||||||||||||||||||||||||
Deemed dividend attributable to Series X
convertible preferred stock |
-
|
8,831
|
-
|
2,083
|
-
|
-
|
(10,914
|
)
|
-
|
(8,831
|
)
|
|||||||||||||||||||||||||
Issuance and reclassification of warrants related to
Series X convertible preferred stock |
-
|
(3,678
|
)
|
-
|
-
|
-
|
1,934
|
-
|
1,934
|
|||||||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(55,523
|
)
|
(55,523
|
)
|
|||||||||||||||||||||||||
Balance at December 31, 2016
|
487
|
$
|
377
|
9,012
|
$
|
8,614
|
45,964,286
|
$
|
46
|
$
|
411,364
|
$
|
(407,554
|
)
|
$
|
12,470
|
|
Year Ended December 31,
|
|||||||||||
|
2016
|
2015
|
2014
|
|||||||||
Cash flows from operating activities:
|
||||||||||||
Net loss
|
$
|
(55,523
|
)
|
$
|
(35,220
|
)
|
$
|
(29,604
|
)
|
|||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||
Depreciation
|
266
|
285
|
344
|
|||||||||
Stock-based compensation expense
|
6,739
|
3,541
|
2,175
|
|||||||||
Change in fair value of warrant liability
|
(1,744
|
)
|
—
|
—
|
||||||||
Common stock issued to settle a license fee obligation
|
—
|
—
|
1,000
|
|||||||||
Amortization of discount and deferred interest on notes payable
|
—
|
—
|
219
|
|||||||||
Amortization of debt issuance cost
|
—
|
—
|
226
|
|||||||||
Changes in operating assets and liabilities:
|
||||||||||||
Accounts receivable
|
326
|
(326
|
)
|
—
|
||||||||
Prepaid expenses and other current assets
|
(1,280
|
)
|
(202
|
)
|
(26
|
)
|
||||||
Accounts payable
|
(477
|
)
|
3,027
|
(1,210
|
)
|
|||||||
Accrued clinical expenses
|
2,507
|
138
|
587
|
|||||||||
Accrued liabilities
|
15
|
(113
|
)
|
(46
|
)
|
|||||||
Accrued payroll and related costs
|
390
|
527
|
734
|
|||||||||
Deferred revenue
|
(138
|
)
|
(2,564
|
)
|
—
|
|||||||
|
||||||||||||
Net cash used in operating activities
|
(48,919
|
)
|
(30,907
|
)
|
(25,601
|
)
|
||||||
|
||||||||||||
Cash flows from investing activities:
|
||||||||||||
Property and equipment purchases
|
(766
|
)
|
(80
|
)
|
—
|
|||||||
Decrease in restricted cash
|
—
|
—
|
10,000
|
|||||||||
|
||||||||||||
Net cash provided by (used in) investing activities
|
(766
|
)
|
(80
|
)
|
10,000
|
|||||||
|
||||||||||||
Cash flows from financing activities:
|
||||||||||||
Proceeds from issuance of Series X Convertible Preferred Stock, warrants and
option to
purchase Series X-1 Convertible Preferred Stock, net of offering cost |
16,844
|
—
|
—
|
|||||||||
Principal payment against note payable
|
—
|
—
|
(18,094
|
)
|
||||||||
Proceeds from issuance of common stock, net of offering costs
|
6,429
|
65,889
|
10,351
|
|||||||||
Proceeds from issuance of common stock to
collaborative partner
|
—
|
9,000
|
—
|
|||||||||
Proceeds from issuance of common stock pursuant to exercise of stock options
and employee stock purchase plan
|
304
|
410
|
37
|
|||||||||
|
||||||||||||
Net cash provided by (used in) financing activities
|
23,577
|
75,299
|
(7,706
|
)
|
||||||||
|
||||||||||||
Net increase (decrease) in cash and cash equivalents
|
(26,108
|
)
|
44,312
|
(23,307
|
)
|
|||||||
|
||||||||||||
Cash and cash equivalents, beginning of period
|
46,951
|
2,639
|
25,946
|
|||||||||
|
||||||||||||
Cash and cash equivalents, end of period
|
$
|
20,843
|
$
|
46,951
|
$
|
2,639
|
||||||
|
||||||||||||
SUPPLEMENTAL CASH DISCLOSURES OF CASH FLOW INFORMATION
|
||||||||||||
Cash paid for interest
|
$
|
—
|
$
|
—
|
$
|
655
|
||||||
Issuance of common stock as a commitment fee pursuant to an equity purchase agreement
|
$
|
87
|
$
|
60
|
$
|
7
|
||||||
Issuance of common stock to settle a license fee obligation
|
$
|
—
|
$
|
1,000
|
$
|
—
|
||||||
Fair value of warrants issued in connection with Series X Convertible Preferred Stock
|
$
|
3,678
|
$
|
—
|
$
|
—
|
1. |
ORGANIZATION AND DESCRIPTION OF BUSINESS
|
2. |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
• |
fees paid to Contract Research Organizations, or CROs, in connection with clinical studies;
|
• |
fees paid to investigative sites in connection with clinical studies;
|
• |
fees paid to contract manufacturers in connection with the production of clinical study materials; and
|
• |
fees paid to vendors in connection with preclinical development activities.
|
3. |
RESEARCH AWARD
|
4. |
FAIR VALUE OF INSTRUMENTS
|
• |
Level 1
—Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by us at the reporting date. Examples of assets and liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and trading securities with quoted prices on active markets.
|
• |
Level 2
—Valuations based on inputs other than the quoted prices in active markets that are observable either directly or indirectly in active markets. Examples of assets and liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds, commercial paper, certificates of deposit and over-the-counter derivatives.
|
• |
Level 3
—Valuations based on unobservable inputs in which there are little or no market data, which requires the Company to develop its own assumptions.
|
|
December 31, 2016
|
|||||||||||||||
|
Estimated
Fair Value
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||
Assets:
|
||||||||||||||||
Money market funds
|
$
|
19,416
|
$
|
19,416
|
$
|
—
|
$
|
—
|
||||||||
|
December 31, 2015
|
|||||||||||||||
|
Estimated
Fair Value
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||
Assets:
|
||||||||||||||||
Money market funds
|
$
|
45,156
|
$
|
45,156
|
$
|
—
|
$
|
—
|
||||||||
Fair value upon issuance on September 14, 2016
|
$
|
3,678
|
||
Change in fair value through November 16, 2016
|
(1,744
|
)
|
||
Balance reclassified to additional paid-in capital
|
$
|
1,934
|
|
November 16,
2016
|
September 14,
2016
|
||||||
Common stock price
|
$
|
1.89
|
$
|
3.20
|
||||
Exercise price
|
$
|
2.36
|
$
|
2.95
|
||||
Expected Volatility
|
84
|
%
|
120
|
%
|
||||
Dividend Yield
|
0
|
%
|
0
|
%
|
||||
Risk-Free Interest Rate
|
1.22
|
%
|
0.90
|
%
|
||||
Expected Term (years)
|
2.82
|
3
|
6. |
PROPERTY AND EQUIPMENT
|
|
December 31,
|
|||||||
|
2016
|
2015
|
||||||
Laboratory equipment
|
$
|
2,013
|
$
|
1,312
|
||||
Computer and software
|
115
|
50
|
||||||
Office furniture and fixture
|
140
|
140
|
||||||
Leasehold improvements
|
206
|
206
|
||||||
Total property and equipment
|
2,474
|
1,708
|
||||||
Less accumulated depreciation and amortization
|
(1,711
|
)
|
(1,445
|
)
|
||||
Property and equipment, net
|
$
|
763
|
$
|
263
|
7. |
COLLABORATIVE ARRANGEMENT
|
8. |
COMMITMENTS AND CONTINGENCIES
|
2017
|
$
|
209
|
||
2018
|
33
|
|||
2019
|
14
|
|||
Total
|
$
|
256
|
9. |
STOCKHOLDERS’ EQUITY (DEFICIT)
|
· |
Series X Convertible Preferred Stock
– Due to the contingent redemption feature related to NASDAQ conversion limits that could result in a potential redemption for cash, the Company initially classified the 17,000 shares of Series X Convertible Preferred Stock in the mezzanine section (between equity and liabilities) on the date of issuance. The Company recorded the residual value of these shares at $9.6 million, which is net of allocation of $3.7 million to the fair value of the warrants to purchase common stock and $3.7 million to the relative fair value of the rights to purchase Series X-1 Convertible Preferred Stock on the date of issuance. On November 16, 2016,
the conversion price became fixed at $1.9692 and therefore, the Series X Convertible Preferred Stock is convertible into 8,632,947 shares of common stock,
which exceeded the aggregate number of common stock permitted for conversion by 247,119 shares or 487 shares of Series X Convertible Preferred Stock. Therefore, the 487 shares of Series X Convertible Preferred Stock remained contingently redeemable on November 16, 2016 and shareholders approval will be required for the conversion of these shares; the remaining 16,513 shares of Series X Convertible Preferred Stock ceased to be redeemable and were reclassified from the mezzanine section to equity.
|
· |
Warrants to Purchase Common Stock
– The Company determined
that, on the date of issuance, the
warrants were not considered indexed to its own stock because the underlying instruments were not “fixed-for-fixed” and therefore, the warrants should be accounted for as derivatives. The warrants were initially measured at fair value at inception of $3.7 million and recorded as a liability with a corresponding entry to Series X Convertible Preferred Stock. On November 16, 2016, the Company remeasured the fair value of the warrants when the exercise price for the warrants became fixed and recorded the change in fair value as part of other income/expense in the Company’s statement of operation. The fair value of the Company’s warrant liability is discussed in Note 5. The number of shares of common stock underlying the warrants also became fixed on November 16, 2016 and therefore, the related warrant liability of $1.9 million was reclassified as stockholders’ equity.
|
· |
Rights to Purchase Series X-1 Convertible Preferred Stock
– The Company determined that the investors’ rights to purchase future shares of Series X-1 Convertible Preferred Stock was a freestanding instrument on issuance. The instrument is treated as equity due to the permanent equity classification of the underlying Series X-1 Convertible Preferred Stock. The right was allocated based on its relative fair value of $3.7 million to the proceeds of the Series X Convertible Preferred Stock and recorded as part of permanent equity. Subsequent to issuance, the Company determined that investors’ right to purchase future shares of Series X-1 Convertible Preferred Stock would not be exercised. As such, the Company reclassified $3.6 million to the Series X shares in permanent equity. At December 31, 2016, no amount remained associated with the Tranche Right. The following table summarizes the assumptions used in the Monte Carlo simulation model to determine the fair value of the option related to the rights to purchase Series X-1 Convertible Preferred Stock on the date of issuance:
|
Common stock price
|
$
|
3.20
|
||
Initial Series X Convertible Preferred Stock conversion price
|
$
|
2.95
|
||
Expected volatility based on blended historical and implied volatilities
|
120
|
%
|
||
Dividend yield
|
0
|
%
|
||
Risk-free interest rate
|
0.90
|
%
|
||
Expected term (years)
|
3
|
· |
Beneficial Conversion Feature
– Because the conversion price of the shares of Series X Convertible Preferred Stock was less than the fair value of the Company’s common stock at the date of issuance, the in-the-money conversion feature (Beneficial Conversion Feature, or BCF) requires separate financial statement recognition and is measured at the intrinsic value (i.e., the amount of the increase in value that preferred stockholders would realize upon conversion based on the value of the conversion shares on the issuance date). The initial BCF of $8.8 million was recorded as a discount to the Contingently Redeemable Series X Convertible Preferred Stock in mezzanine and was immediately accreted as a deemed preferred stock dividend and, accordingly, an adjustment to net loss to arrive at net loss applicable to common stockholders. The BCF was reassessed on November 16, 2016 when the conversion price of the Series X shares became fixed and resulted in an additional $0.8 million being recorded as a reduction to the Series X Convertible Preferred Stock in permanent equity. No deemed dividend was recorded as the shares were no longer redeemable.
|
· |
Conversion of Series X Convertible Preferred Stock
– On December 7, 2016, pursuant to a conversion notice received from one of the holders of the Series X Convertible Preferred Stock, the Company converted 7,501 shares of Series X Convertible Preferred Stock into 3,809,160 shares of common stock, leaving a balance of 9,499 shares of Series X Convertible Preferred Stock outstanding as of December 31, 2016. The conversion was reflected as a reduction in Series X Convertible Preferred Stock in permanent equity. The unamortized discount was recognized as a deemed dividend of $2.1 million in connection with the conversion of the Series X Convertible Preferred Stock,
|
Convertible Series X preferred stock
|
4,576,668
|
|||
Common stock options outstanding
|
5,996,024
|
|||
Common stock warrants outstanding
|
2,198,414
|
|||
Common stock options available for future grant under stock option plan
|
472,676
|
|||
Common stock available for future grant under ESPP plan
|
68,677
|
|||
Total
|
13,312,459
|
10. |
STOCK-BASED AWARDS
|
Number of
Options
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual
Life in
Years
|
Aggregate
Intrinsic
Value
(in thousands)
|
|||||||||||||
Balance at December 31, 2013
|
1,997,075
|
$
|
5.21
|
9.11
|
$
|
48
|
||||||||||
Options granted
|
1,389,743
|
$
|
2.00
|
|||||||||||||
Options exercised
|
(2,000
|
)
|
$
|
2.08
|
||||||||||||
Options cancelled/forfeited
|
(362,849
|
)
|
$
|
5.78
|
||||||||||||
Balance at December 31, 2014
|
3,021,969
|
$
|
3.67
|
8.92
|
$
|
0
|
||||||||||
Options granted
|
1,392,499
|
$
|
7.10
|
|||||||||||||
Options exercised
|
(80,218
|
)
|
$
|
3.73
|
||||||||||||
Options cancelled/forfeited
|
(78,269
|
)
|
$
|
4.01
|
||||||||||||
Balance at December 31, 2015
|
4,255,981
|
$
|
4.79
|
8.44
|
$
|
4,330
|
||||||||||
Options granted
|
2,960,142
|
$
|
3.27
|
|||||||||||||
Options exercised
|
(116,773
|
)
|
$
|
2.20
|
||||||||||||
Option forfeited
|
(440,000
|
)
|
$
|
9.48
|
||||||||||||
Options cancelled
|
(663,326
|
)
|
$
|
5.06
|
||||||||||||
Balance at December 31, 2016
|
5,996,024
|
$
|
3.73
|
8.19
|
$
|
0
|
||||||||||
Ending vested at December 31, 2016
|
2,602,023
|
$
|
4.11
|
7.20
|
$
|
0
|
||||||||||
Vested and expected to vest at December 31, 2016
|
5,575,887
|
$
|
3.76
|
8.12
|
$
|
0
|
Years Ended December 31,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Expected Volatility
|
98
|
%
|
94
|
%
|
91
|
%
|
||||||
Dividend Yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||||
Risk-Free Interest Rate
|
1.51
|
%
|
1.70
|
%
|
1.60
|
%
|
||||||
Expected Term (years)
|
5.90
|
5.92
|
5.22
|
|||||||||
Weighted-average fair value per option
|
$
|
2.53
|
$
|
5.40
|
$
|
1.35
|
|
Years Ended December 31,
|
|||||||||||
|
2016
|
2015
|
2014
|
|||||||||
Intrinsic value of options exercised
|
$
|
177
|
$
|
140
|
$
|
3
|
||||||
Proceeds received from the exercise of stock options
|
$
|
257
|
$
|
299
|
$
|
4
|
Options Outstanding
|
Options Vested & Exercisable
|
|||||||||||||||
Range of Exercise Price
|
Number of Shares
|
Weighted-Average
Remaining Contractual Life (In Years) |
Number of Shares
|
Weighted-Average
Remaining Contractual Life (In Years) |
||||||||||||
$ 1.47 - $2.86
|
1,461,031
|
8.22 |
653,306
|
7.41
|
||||||||||||
$ 2.89 - $4.61
|
2,821,394
|
9.09
|
676,873
|
8.47
|
||||||||||||
$ 4.75 - $9.48
|
1,665,132
|
6.72
|
1,236,294
|
6.48
|
||||||||||||
$ 10.72 - $33.52
|
45,092
|
5.35
|
32,175
|
4.05
|
||||||||||||
$ 65.36 - $65.36
|
3,375
|
4.50
|
3,375
|
4.50
|
||||||||||||
Total
|
5,996,024
|
8.19
|
2,602,023
|
7.20
|
|
Years Ended December 31,
|
|||||||||||
|
2016
|
2015
|
2014
|
|||||||||
Expected Volatility
|
97
|
%
|
82
|
%
|
41
|
%
|
||||||
Dividend Yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||||
Risk-Free Interest Rate
|
0.38
|
%
|
0.08
|
%
|
0.05
|
%
|
||||||
Expected Term (years)
|
0.50
|
0.50
|
0.50
|
|||||||||
Weighted-average grant date fair value per right
|
$
|
1.50
|
$
|
1.04
|
$
|
1.04
|
Years Ended December 31,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Research and development
|
$
|
1,795
|
$
|
1,453
|
$
|
825
|
||||||
General and administrative
(1)
|
4,944
|
2,088
|
1,350
|
|||||||||
Total employee stock-based compensation
|
$
|
6,739
|
$
|
3,541
|
$
|
2,175
|
(1)
|
Included in general and administrative expense was approximately $1.5 million in stock-based compensation associated with the cancellation of options by a former employee in December 2016.
|
Year Ended December 31
,
|
||||||||||||
2016 | 2015 | 2014 | ||||||||||
Net loss per share
|
||||||||||||
Numerator
|
||||||||||||
Net loss
|
$
|
(55,523
|
)
|
$
|
(35,220
|
)
|
$
|
(29,604
|
)
|
|||
Deemed dividend attributable to preferred stock
|
(10,914
|
)
|
—
|
—
|
||||||||
Net loss applicable to common stockholders
|
$
|
(66,437
|
)
|
$
|
(35,220
|
)
|
$
|
(29,604
|
)
|
|||
Denominator
|
||||||||||||
Weighted average common shares outstanding
|
41,310,269
|
35,631,237
|
21,776,269
|
|||||||||
Basic and diluted net loss per share
|
$
|
(1.61
|
)
|
$
|
(0.99
|
)
|
$
|
(1.36
|
)
|
Year Ended December 31,
|
||||||||||||
2016 |
2015
|
2014
|
||||||||||
Total options to purchase common stock
|
5,996,024
|
4,255,981
|
3,021,969
|
|||||||||
Total warrants to purchase common stock
|
2,198,414
|
40,178
|
556,838
|
|||||||||
Series X convertible preferred stock
|
4,576,668
|
—
|
—
|
|||||||||
Total restricted stock units
|
—
|
—
|
937
|
|||||||||
Total
|
12,771,106
|
4,296,159
|
3,579,744
|
12. |
EMPLOYEE BENEFIT PLAN
|
13. |
INCOME TAXES
|
|
December 31,
|
|||||||||||
|
2016
|
2015
|
2014
|
|||||||||
Current:
|
||||||||||||
Federal
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
State
|
1
|
1
|
1
|
|||||||||
Foreign
|
—
|
—
|
—
|
|||||||||
Total current
|
1
|
1
|
1
|
|||||||||
Deferred:
|
||||||||||||
Federal
|
(20,942
|
)
|
(11,080
|
)
|
(9,046
|
)
|
||||||
State
|
8,936
|
(3,250
|
)
|
(2,689
|
)
|
|||||||
Foreign
|
—
|
—
|
—
|
|||||||||
Total deferred
|
(12,006
|
)
|
(14,330
|
)
|
(11,735
|
)
|
||||||
Valuation allowance
|
12,006
|
14,330
|
11,735
|
|||||||||
Total provision for income taxes
|
$
|
—
|
$
|
—
|
$
|
—
|
|
December 31,
|
|||||||
|
2016
|
2015
|
||||||
Deferred tax assets:
|
||||||||
Net operating loss carryforwards
|
$
|
44,909
|
$
|
37,576
|
||||
Tax credits
|
4,084
|
3,023
|
||||||
Intangible assets
|
1,470
|
2,033
|
||||||
Capitalized R&D
|
40,297
|
35,514
|
||||||
Other
|
1,677
|
2,285
|
||||||
Total deferred tax assets
|
92,437
|
80,431
|
||||||
Deferred tax liabilities
|
—
|
—
|
||||||
Valuation allowance
|
(92,437
|
)
|
(80,431
|
)
|
||||
Net deferred tax asset
|
$
|
—
|
$
|
—
|
|
2016
|
2015
|
2014
|
|||||||||
Statutory rate
|
34
|
%
|
34
|
%
|
34
|
%
|
||||||
State tax
|
(9
|
)%
|
6
|
%
|
6
|
%
|
||||||
Tax credit
|
1
|
%
|
2
|
%
|
1
|
%
|
||||||
Deemed dividend and warrant liability revaluation
|
(4
|
)%
|
—
|
%
|
—
|
%
|
||||||
Stock based compensation
|
(4
|
)%
|
(1
|
)%
|
(1
|
)%
|
||||||
Valuation allowance
|
(18
|
)%
|
(41
|
)%
|
(40
|
)%
|
||||||
Effective tax rates
|
0
|
%
|
0
|
%
|
0
|
%
|
|
Amount
|
Expiration Years
|
|||
Net operating losses—federal
|
$
|
117,090
|
Beginning 2024
|
||
Net operating losses—state
|
$
|
89,251
|
Beginning 2017
|
||
Tax return credits—federal
|
$
|
2,342
|
Beginning 2032
|
||
Tax return credits—state
|
$
|
2,640
|
Do not expire
|
|
Amount
|
|||
Balance as of December 31, 2013
|
828
|
|||
Additions based on tax positions related to prior year
|
—
|
|||
Additions based on tax positions related to current year
|
171
|
|||
Balance as of December 31, 2014
|
$
|
999
|
||
Additions based on tax positions related to prior year
|
—
|
|||
Additions based on tax positions related to current year
|
269
|
|||
Balance as of December 31, 2015
|
$
|
1,268
|
||
Deductions based on tax positions related to prior year
|
(27
|
)
|
||
Additions based on tax positions related to current year
|
420
|
|||
Balance as of December 31, 2016
|
$
|
1,661
|
14. |
SUMMARIZED QUARTERLY UNAUDITED FINANCIAL DATA
|
Quarter Ended
|
||||||||||||||||
March 31,
|
June 30,
|
September 30,
|
December 31,
|
|||||||||||||
2016
|
||||||||||||||||
REVENUES:
|
||||||||||||||||
License revenue
|
$
|
139
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||
Collaborative revenue
|
6
|
—
|
—
|
—
|
||||||||||||
Total revenues
|
145
|
—
|
—
|
—
|
||||||||||||
OPERATING EXPENSES:
|
||||||||||||||||
Research and development
|
$
|
9,624
|
$
|
11,966
|
$
|
14,096
|
$
|
10,825
|
||||||||
General and administrative
|
2,238
|
2,576
|
2,504
|
3,754
|
||||||||||||
Research award
|
—
|
(261
|
)
|
—
|
—
|
|||||||||||
LOSS FROM OPERATIONS
|
(
11,717
|
)
|
(14,281
|
)
|
(
16,600
|
)
|
(14,579
|
)
|
||||||||
Other income (expense)
|
(9
|
)
|
(
53
|
)
|
(47
|
)
|
19
|
|||||||||
Change in fair value of warrant liability
|
—
|
—
|
169
|
1,575
|
||||||||||||
NET LOSS
|
$
|
(
11,726
|
)
|
$
|
(
14,334
|
)
|
$
|
(
16,478
|
)
|
$
|
(12,985
|
)
|
||||
Deemed dividend attributable to preferred
stock
|
—
|
—
|
(8,807
|
)
|
(2,107
|
)
|
||||||||||
Net loss applicable to common stockholders
|
(11,726
|
)
|
(14,334
|
)
|
(25,285
|
)
|
(15,092
|
)
|
||||||||
Net loss per share—basic and diluted
|
$
|
(0.29
|
)
|
$
|
(0.35
|
)
|
$
|
(0.61
|
)
|
$
|
(0.36
|
)
|
||||
Shares used in computing basic and diluted
net loss per share
|
40,049,895
|
41,032,544
|
41,682,669
|
42,459,248
|
Quarter Ended
|
||||||||||||||||
March 31,
|
June 30,
|
September 30,
|
December 31,
|
|||||||||||||
2015
|
||||||||||||||||
REVENUES:
|
||||||||||||||||
License revenue
|
$
|
49
|
$
|
146
|
$
|
548
|
$
|
1,819
|
||||||||
Collaborative revenue
|
196
|
143
|
185
|
99
|
||||||||||||
Total revenues
|
245
|
289
|
733
|
1,918
|
||||||||||||
OPERATING EXPENSES:
|
||||||||||||||||
Research and development
|
$
|
5,995
|
$
|
8,539
|
$
|
10,359
|
$
|
8,605
|
||||||||
General and administrative
|
1,907
|
1,696
|
2,091
|
1,874
|
||||||||||||
Research award
|
—
|
(1,100
|
)
|
(367
|
)
|
(1,171
|
)
|
|||||||||
LOSS FROM OPERATIONS
|
(
7,657
|
)
|
(8,846
|
)
|
(
11,350
|
)
|
(
7,390
|
)
|
||||||||
Other income (expense)
|
(3
|
)
|
(
49
|
)
|
24
|
51
|
||||||||||
NET LOSS
|
$
|
(
7,660
|
)
|
$
|
(
8,895
|
)
|
$
|
(
11,326
|
)
|
$
|
(7,339
|
)
|
||||
Net loss per share—basic and diluted
|
$
|
(0.28
|
)
|
$
|
(0.25
|
)
|
$
|
(0.29
|
)
|
$
|
(0.18
|
)
|
||||
Shares used in computing basic and
diluted net loss per share
|
27,595,081
|
35,817,794
|
39,241,738
|
39,947,036
|
|
ANTHERA PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ Craig Thompson
|
|
|
|
Craig Thompson
|
|
|
|
|
|
|
|
Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
Signature
|
Title
|
Date
|
|
|
|
/s/ Craig Thompson
|
Chief Executive Officer and Director (Principal Executive Officer)
|
March 16, 2017
|
Craig Thompson
|
|
|
|
|
|
/s/ May Liu
|
Senior Vice President, Finance and Administration (Principal
Accounting Officer)
|
March 16, 2017
|
May Liu
|
|
|
|
|
|
/s/ Paul F. Truex
|
Chairman of the Board of Directors
|
March 16, 2017
|
Paul F. Truex
|
|
|
|
|
|
/s/ Christopher S. Henney
|
Director
|
March 16, 2017
|
Christopher S. Henney
|
|
|
|
|
|
/s/ Brian R. Mueller
|
Director
|
March 16, 2017
|
Brian R. Mueller
|
|
|
|
|
|
/s/ Steven B. Engle
|
Director
|
March 16, 2017
|
Steven B. Engle
|
|
|
|
|
|
/s/ David E. Thompson
|
Director
|
March 16, 2017
|
David E. Thompson
|
|
|
/s/ Brent V. Furse
|
Director
|
March 16, 2017
|
Brent V. Furse
|
|
|
|
|
|
/
s/ Philip T. Sager
|
Director
|
March 16, 2017
|
Philip T. Sager
|
|
|
Number
|
|
Description
|
|
|
|
3.1
|
|
Fifth Amended and Restated Certificate of Incorporation(1)
|
|
|
|
3.2
|
|
Certificate of Amendment to the Fifth Amended and Restated Certificate of Incorporation filed October 12, 2012(2)
|
|
|
|
3.3
|
|
Certificate of Amendment to the Fifth Amended and Restated Certificate of Incorporation filed July 12, 2013 and effective July 15, 2013(3)
|
3.5
|
|
Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of Series X Convertible Preferred Stock filed on September 15, 2016 (5)
|
3.6
|
|
Form of Certificate of Designation of Preferences, Rights and Limitations of Series X-1 Convertible Preferred Stock filed on September 12, 2016(6)
|
|
|
|
3.7
|
|
Amended and Restated Bylaws, as amended on May 21, 2015(7)
|
|
|
|
4.1
|
|
Specimen certificate evidencing shares of common stock(8)
|
|
|
|
4.2
|
|
Specimen Series X Convertible Preferred Stock certificate(9)
|
|
|
|
4.3
|
|
Form of Warrant sold pursuant to that Securities Purchase Agreement, among the Company and the purchasers thereto, dated September 20, 2010(10)
|
|
|
|
4.4
|
|
Form of Warrant Agreement dated as of March 25, 2011(11)
|
4.5
|
|
Form of Warrant sold pursuant to that Subscription Agreement, among the Company and the purchasers thereto, dated September 6, 2016(12)
|
|
|
|
#10.1
|
|
2005 Equity Incentive Plan and form agreements thereunder(13)
|
|
|
|
#10.2
|
|
Amended and Restated 2010 Stock Option and Incentive Plan(14)
|
|
|
|
#10.3
|
|
Certificate of Amendment to Amended and Restated 2010 Stock Option and Incentive Plan(15)
|
|
|
|
#10.4
|
|
Form of Non-Qualified Stock Option Agreement for Company Employees Under the Anthera Pharmaceuticals, Inc. 2010 Stock Option and Incentive Plan(16)
|
|
|
|
#10.5
|
|
Form of Non-Qualified Stock Option Agreement for Non-Employee Directors Under the Anthera Pharmaceuticals, Inc. 2010 Stock Option and Incentive Plan(16)
|
|
|
|
#10.6
|
|
Form of Incentive Stock Option Agreement Under the Anthera Pharmaceuticals, Inc. 2010 Stock Option and Incentive Plan(16)
|
|
|
|
#10.7
|
|
Form of Restricted Stock Award Agreement Under the Anthera Pharmaceuticals, Inc. 2010 Stock Option and Incentive Plan(16)
|
|
|
|
#10.8
|
|
Restricted Stock Unit Award Agreement Under the Anthera Pharmaceuticals, Inc. 2010 Stock Option and Incentive Plan(17)
|
|
|
|
#10.9
|
|
2010 Employee Stock Purchase Plan(18)
|
|
|
|
#10.10
|
|
Amendment No. 1 to 2010 Employee Stock Purchase Plan(19)
|
|
|
|
#10.11
|
|
Amendment No. 2 to 2010 Employee Stock Purchase Plan(20)
|
|
|
|
#10.12
|
|
2013 Stock Option and Incentive Plan(21)
|
#10.13
|
|
Form of Non-Qualified Stock Option Agreement for Company Employees Under the 2013 Stock Option and Incentive Plan(22)
|
|
|
|
#10.14
|
|
Form of Non-Qualified Stock Option Agreement for Non-Employees Directors Under the 2013 Stock Option and Incentive Plan(22)
|
|
|
|
#10.15
|
|
Form of Incentive Stock Option Agreement Under the 2013 Stock Option and Incentive Plan(22)
|
|
|
|
#10.16
|
|
Form of Restricted Stock Award Agreement Under the 2013 Stock Option and Incentive Plan(22)
|
|
|
|
#10.17
|
|
Form of Restricted Stock Unit Award Agreement Under the 2013 Stock Option and Incentive Plan(22)
|
|
|
|
#10.18
|
|
Form of Amended and Restated Indemnification Agreement(23)
|
#10.19
|
|
Form of Amended and Restated Change in Control Agreement(24)
|
|
|
|
#10.20
|
|
Form of Amended and Restated Severance Benefits Agreement(25)
|
|
|
|
+10.21
|
|
License Agreement between Amgen Inc. and the Company, dated as of December 18, 2007(26)
|
|
|
|
10.22
|
|
Amendment No. 1 to License Agreement between Amgen Inc. and the Company, dated as of October 16, 2009(27)
|
|
|
|
+10.23
|
|
Amendment No. 2 to License Agreement between Amgen Inc. and the Company, dated as of November 26, 2014(28)
|
|
|
|
10.24
|
|
Form of Securities Purchase Agreement, among the Company and the purchasers thereto, dated September 20, 2010(29)
|
|
|
|
10.25
|
|
Lease by and between the Company and MEPT Mount Eden LLC, dated as of May 4, 2011(30)
|
|
|
|
10.26
|
|
Lease Amendment by and between the Company and MEPT Mount Eden LLC, dated as of November 13, 2013(31)
|
|
|
|
+10.27
|
|
License Agreement between the Company and Eli Lilly, dated as of July 11, 2014(32)
|
|
|
|
+10.28
|
|
Collaboration and License Agreement between the Company and Zenyaku Kogyo Co., Ltd., dated as of December 11, 2014(33)
|
|
|
|
+10.29
|
|
Stock Purchase Agreement between the Company and Zenyaku Kogyo Co., Ltd., dated as of December 11, 2014(34)
|
|
|
|
+10.30
|
|
Subscription Agreement between the Company and Zenyaku Kogyo Co., Ltd., dated as of January 27, 2015(35)
|
|
|
|
+10.31
|
|
Subscription Agreement between the Company and Amgen Inc., dated as of January 27, 2015(36)
|
|
|
|
+10.32
|
|
Subscription Agreement between the Company and Zenyaku Kogyo Co., Ltd., dated as of August 14, 2015 (37)
|
|
|
|
#10.33
|
|
Deferred Compensation Election Form by and between the Company and Paul Truex, effective as of December 28, 2015 (38)
|
|
|
|
#10.34
|
|
Employment Offer Letter between the Company and Mr. Craig Thompson, dated as of December 4, 2015 (39)
|
|
|
|
#10.35
|
|
Employment Agreement, by and between the Company and Mr. Paul Truex, dated as of January 25, 2016 (40)
|
|
|
|
#10.36
|
|
Employment Agreement, by and between the Company and Mr. Craig Thompson, dated as of January 25, 2016 (41)
|
|
|
|
#10.37
|
|
Employment Agreement, by and between the Company and Dr. Colin Hislop, dated as of January 25, 2016 (42)
|
|
|
|
#10.38
|
|
Employment Agreement, by and between the Company and Ms. Klara Dickinson-Eason, dated as of January 25, 2016 (43)
|
|
|
|
#10.39
|
|
Employment Agreement, by and between the Company and Dr. Chuck Olson, dated as of January 25, 2016 (44)
|
#10.40
|
|
Employment Agreement, by and between the Company and Ms. May Liu, dated as of January 25, 2016 (45)
|
|
|
|
#10.41
|
|
Employment Offer Letter, by and between the Company and Dr. James Pennington, dated as of April 1, 2016 (46)
|
#10.42
|
|
Employment Offer Letter, by and between the Company and Dr. William Shanahan, dated as of April 25, 2016 (47)
|
#10.43
|
|
Amended and Restated Employment Offer Letter, by and between the Company and Mr. Craig Thompson, dated as of December 6, 2016 (filed herewith)
|
10.41
|
|
Stock Purchase Agreement between the Company and Lincoln Park Capital Fund, LLC, dated as of March 12, 2015 (48)
|
|
|
|
10.42
|
|
Amendment to the Stock Purchase Agreement between the Company and Lincoln Park Capital Fund LLC, dated as of July 8, 2015 (49)
|
10.43
|
Amendment to the Stock Purchase Agreement between the Company and Lincoln Park Capital Fund LLC, dated as of April 27, 2016 (50)
|
|
10.44
|
At Market Issuance Sales Agreement, dated April 21, 2016, between Anthera Pharmaceuticals, Inc. and H.C. Wainwright & Co., LLC (51)
|
|
10.45
|
Subscription Agreement, dated September 6, 2016, between Anthera Pharmaceuticals, Inc. and purchasers affiliated with Biotechnology Value Fund, L.P. and Rock Springs Capital Master Fund LP (filed as Exhibit 10.1 to the registrant's Form 8-K filed with the SEC on September 12, 2016 and incorporated herein by reference)(52)
|
|
|
|
|
14.1
|
|
Code of Ethics (53)
|
|
|
|
21.1
|
|
Subsidiaries of Anthera Pharmaceuticals, Inc.(54)
|
|
|
|
23.1
|
|
Consent of BDO USA LLP, independent registered public accounting firm
|
|
|
|
24.1
|
|
Power of Attorney (included on signature page hereto)
|
|
|
|
31.1
|
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
31.2
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|
32.1 |
Certification of Principal Executive Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
32.2
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant Section 906 of the Sarbanes-Oxley Act of 2002
|
+
|
Certain provisions of this Exhibit have been omitted pursuant to a request for confidential treatment.
|
#
|
Indicates management contract or compensatory plan, contract or agreement.
|
(1)
|
Filed as Exhibit 3.6 to the registrant’s Registration Statement on Form S-1/A (File No. 333-161930), filed with the SEC on February 3, 2010 and incorporated herein by reference.
|
(2)
|
Filed as the same numbered exhibit to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 26, 2013 and incorporated herein by reference.
|
(3)
|
Filed as Exhibit 3.1 to the registrant Current Report on Form 8-K, filed with the SEC on July 16, 2013 and incorporated herein by reference.
|
(
4)
|
Filed as Exhibit 3.1 to the registrant Current Report on Form 8-K, filed with the SEC on September 12, 2016 and incorporated herein by reference.
|
(5)
|
Filed as Exhibit 3.1 to the registrant's Form 8-K filed with the SEC on September 15, 2016 and incorporated herein by reference.
|
(6)
|
Filed as Exhibit 3.2 to the registrant Current Report on Form 8-K, filed with the SEC on September 12, 2016 and incorporated herein by reference.
|
(7)
|
Filed as Exhibit 3.4 to the registrant’s Quarterly Report on Form 10-Q filed with the SEC on August 10, 2015 and incorporated herein by reference.
|
(8)
|
Filed as the same numbered exhibit to the registrant’s Amendment No. 3 to Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on January 29, 2010 and incorporated herein by reference.
|
(9)
|
Filed as Exhibit 4.2 to the registrant’s Current Report on Form 8-K, filed with the SEC on September 12, 2016 and incorporated herein by reference.
|
(10)
|
Filed as Exhibit 4.1 to the registrant’s Current Report on Form 8-K, filed with the SEC on September 22, 2010 and incorporated herein by reference.
|
(11)
|
Filed as Exhibit 10.2 to the registrant’s Current Report on Form 8-K, filed with the SEC on March 29, 2011 and incorporated herein by reference.
|
(12)
|
Filed as Exhibit 4.1 to the registrant’s Current Report on Form 8-K, filed with the SEC on September 6, 2016 and incorporated herein by reference.
|
(13)
|
Filed as the same numbered exhibit to the registrant’s Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on September 15, 2009 and incorporated herein by reference.
|
(14)
|
Filed as Appendix A to the registrant’s Definitive Proxy Statement on Schedule 14A, filed with the SEC on June 8, 2010 and incorporated herein by reference.
|
(15)
|
Filed as Exhibit 10.2 to registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 12, 2011 and incorporated herein by reference.
|
(16)
|
Filed as Exhibit 10.2 to the registrant’s Amendment No. 4 to Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on February 3, 2010 and incorporated herein by reference.
|
(17)
|
Filed as Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 14, 2010 and incorporated herein by reference.
|
(18)
|
Filed as Appendix B to the registrant’s Definitive Proxy Statement on Schedule 14A, filed with the SEC on June 8, 2010 and incorporated herein by reference.
|
(19)
|
Filed as Exhibit 10.42 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 7, 2011 and incorporated herein by reference.
|
(20)
|
Filed as Exhibit 10.34 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 26, 2013 and incorporated herein by reference.
|
(21)
|
Filed as Annex B to the registrants Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 5, 2013 and incorporated herein by reference.
|
(22)
|
Filed as the same numbered exhibit to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 28, 2014 and incorporated herein by reference.
|
(23)
|
Filed as Exhibit 10.3 to the registrant’s Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on September 15, 2009 and incorporated herein by reference.
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(24)
|
Filed as the Exhibit 10.4 to the registrant’s Amendment No. 1 to Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on October 19, 2009 and incorporated herein by reference.
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(25)
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Filed as the Exhibit 10.5 to the registrant’s Amendment No. 1 to Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on October 19, 2009 and incorporated herein by reference.
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(26)
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Filed as Exhibit 10.10 to the registrant’s Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on September 15, 2009 and incorporated herein by reference.
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(27)
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Filed as Exhibit 10.18 to the registrant’s Amendment No. 1 to Registration Statement on Form S-1 (File No. 333-161930), filed with the SEC on October 19, 2009 and incorporated herein by reference.
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(28)
|
Filed as Exhibit 10.23 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 16, 2015, and incorporated herein by reference.
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(29)
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Filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K, filed with the SEC on September 22, 2010 and incorporated herein by reference.
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(30)
|
Filed as Exhibit 10.4 to the registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 13, 2011, and incorporated herein by reference.
|
(31)
|
Filed as Exhibit 10.27 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 28, 2014, and incorporated herein by reference.
|
(32)
|
Filed as Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q/A, filed with the SEC on December 12, 2014 and incorporated herein by reference
|
(33)
|
Filed as Exhibit 10.33 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 16, 2015 and incorporated herein by reference
|
(34)
|
Filed as Exhibit 10.34 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 16, 2015 and incorporated herein by reference
|
(35)
|
Filed as Exhibit 10.35 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 16, 2015 and incorporated herein by reference
|
(36)
|
Filed as Exhibit 10.36 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 16, 2015 and incorporated herein by reference
|
(37)
|
Filed as Exhibit 10.32 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2016 and incorporated herein by reference
|
(38)
|
Filed as Exhibit 10.33 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2016 and incorporated herein by reference
|
(39)
|
Filed as Exhibit 10.34 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2016 and incorporated herein by reference
|
(40)
|
Filed as Exhibit 10.35 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2016 and incorporated herein by reference
|
(41)
|
Filed as Exhibit 10.36 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2016 and incorporated herein by reference
|
(42)
|
Filed as Exhibit 10.37 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2016 and incorporated herein by reference
|
(43)
|
Filed as Exhibit 10.38 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2016 and incorporated herein by reference
|
(44)
|
Filed as Exhibit 10.39 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2016 and incorporated herein by reference
|
(45)
|
Filed as Exhibit 10.40 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2016 and incorporated herein by reference
|
(46)
|
Filed as Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 10, 2016 and incorporated herein by reference
|
(47)
|
Filed as Exhibit 10.4 to the registrant’s Quarterly Report on Form 10-Q, filed with the SEC on November 7, 2016 and incorporated herein by reference
|
(48)
|
Filed as Exhibit 10.1 to the registrant’s Current Report on Form 8-K, filed with the SEC on March 16, 2015 (dated March 12, 2015) and incorporated herein by reference
|
(49)
|
Filed as Exhibit 10.1 to the registrant's Form 8-K, filed with the SEC on April 27, 2016 and incorporated herein by reference
|
(50)
|
Filed as Exhibit 10.1 to the registrant's Form 8-K, filed with the SEC on April 21, 2016 and incorporated herein by reference
|
(51)
|
Filed as the same numbered exhibit to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 7, 2011 and incorporated herein by reference
|
(52)
|
Filed as Exhibit 10.1 to the registrant’s Form 8-K filed with the SEC on September 12, 2016 and incorporated herein by reference.
|
(53)
|
Filed as the same numbered exhibit to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 7, 2011 and incorporated herein by reference
|
(54)
|
Filed as the same numbered exhibit to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 14, 2012 and incorporated herein by reference
|
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