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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 |
☒
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934P
|
Delaware
|
|
20-1852016
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(State or Other Jurisdiction of Incorporation or Organization)
|
|
(I.R.S. Employer Identification No.)
|
|
|
|
25801 Industrial Boulevard, Suite B
|
|
|
Hayward, California
|
|
94545
|
(Address of Principal Executive Offices)
|
|
(Zip Code)
|
Large accelerated filer
☐
|
|
Accelerated filer
☐
|
Non-accelerated filer
☐
|
|
Smaller reporting company
☒
|
(Do not check if a smaller reporting company)
|
|
Emerging growth company
☐
|
|
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|
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Page
|
Part I — Financial Information
|
|
3 | |
3 | |
4 | |
5 | |
6 | |
7 | |
16 | |
20 | |
20 | |
|
|
Part II — Other Information
|
|
21 | |
21 | |
36 | |
37 |
ASSETS
|
March 31, 2018
|
December 31, 2017
|
||||||
|
(1)
|
|
||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
8,086
|
$
|
2,196
|
||||
Prepaid expenses and other current assets
|
653
|
995
|
||||||
Total current assets
|
8,739
|
3,191
|
||||||
Property and equipment — net
|
72
|
482
|
||||||
TOTAL
|
$
|
8,811
|
$
|
3,673
|
||||
|
||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
1,845
|
$
|
1,832
|
||||
Accrued clinical expenses
|
756
|
1,785
|
||||||
Accrued liabilities
|
45
|
28
|
||||||
Accrued payroll and related costs
|
—
|
1,066
|
||||||
Total current liabilities
|
2,646
|
4,711
|
||||||
Warrant liability
|
704
|
4,457
|
||||||
Total liabilities
|
3,350
|
9,168
|
||||||
Commitments and Contingencies (Note 6)
|
||||||||
Stockholders’ equity (deficit) :
|
||||||||
Series X Convertible Preferred Stock, $0.001 par value, 5,000,000 shares
authorized; 0 and 430 shares issued and outstanding as of March 31, 2018 and
December 31, 2017, respectively |
—
|
333
|
||||||
Common stock, $0.001 par value, 100,000,000 shares authorized; 26,179,302
and 13,854,491 shares issued and outstanding as of March 31, 2018 and December 31, 2017, respectively |
26
|
14
|
||||||
Additional paid-in capital
|
447,587
|
428,586
|
||||||
Accumulated deficit
|
(442,152
|
)
|
(434,428
|
)
|
||||
Total stockholders’ equity (deficit)
|
5,461
|
(5,495
|
)
|
|||||
TOTAL
|
$
|
8,811
|
$
|
3,673
|
(1) |
Derived from audited Financial Statements.
|
|
Three Months Ended
March 31,
|
|||||||
|
2018
|
2017
|
||||||
OPERATING EXPENSES
|
||||||||
Research and development
|
7,468
|
7,801
|
||||||
General and administrative
|
3,503
|
2,903
|
||||||
Research award
|
—
|
(100
|
)
|
|||||
Total operating expenses
|
10,971
|
10,604
|
||||||
LOSS FROM OPERATIONS
|
(10,971
|
)
|
(10,604
|
)
|
||||
OTHER EXPENSE:
|
||||||||
Other income (expense)
|
(43
|
)
|
(3
|
)
|
||||
Fair value of warrant liability in excess of proceeds from financing
|
—
|
(600
|
)
|
|||||
Change in fair value of warrant liability
|
3,290
|
—
|
||||||
Total other income (expense)
|
3,247
|
(603
|
)
|
|||||
|
||||||||
NET LOSS
|
$
|
(7,724
|
)
|
$
|
(11,207
|
)
|
||
Deemed dividends attributable to preferred stock
|
(1,540
|
)
|
(2,503
|
)
|
||||
Net loss applicable to common stockholders
|
$
|
(9,264
|
)
|
$
|
(13,710
|
)
|
||
Net loss per share applicable to common
stockholders — basic and diluted (1)
|
$
|
(0.42
|
)
|
$
|
(2.03
|
)
|
||
|
||||||||
Weighted-average number of shares used in
per share calculation — basic and diluted (1)
|
22,166,869
|
6,759,567
|
(1) |
All per share amounts and shares of the Company’s common stock issued and outstanding for all periods have been retroactively adjusted to reflect the one-for-eight reverse stock split which became effective April 28, 2017.
|
Series X Convertible
Preferred Stock
|
Class Y 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, 2017
|
430
|
$
|
333
|
-
|
$
|
-
|
13,854,491
|
$
|
14
|
$
|
428,586
|
$
|
(434,428
|
)
|
$
|
(5,495
|
)
|
|||||||||||||||||||
Issuance of common stock pursuant to employee stock purchase plan
|
-
|
-
|
-
|
-
|
27,630
|
-
|
40
|
-
|
40
|
|||||||||||||||||||||||||||
Share-based compensation related to equity awards
|
-
|
-
|
-
|
-
|
-
|
-
|
3,266
|
-
|
3,266
|
|||||||||||||||||||||||||||
Issuance of common stock pursuant to exercise of warrants
|
-
|
-
|
-
|
-
|
1,902,683
|
2
|
2,992
|
-
|
2,994
|
|||||||||||||||||||||||||||
Issuance of common stock pursuant to an equity purchase agreement,
net of issuance cost of $16 |
-
|
-
|
-
|
-
|
673,939
|
1
|
1,308
|
-
|
1,308
|
|||||||||||||||||||||||||||
Issuance of common stock for cash at $1.25 per share in a private placement,
net of issuance cost of $450
|
-
|
-
|
-
|
-
|
7,625,741
|
7
|
4,771
|
-
|
4,779
|
|||||||||||||||||||||||||||
Issuance of warrants pursuant to a private placement, net of issuance cost of $471
|
-
|
-
|
-
|
-
|
-
|
-
|
4,999
|
-
|
4,999
|
|||||||||||||||||||||||||||
Issuance of Class Y convertible preferred stock for cash at $1.25 per share
in a private placement
|
-
|
-
|
2,067,522
|
1,416
|
-
|
-
|
(122
|
)
|
-
|
1,294
|
||||||||||||||||||||||||||
Beneficial conversion feature on Class Y convertible preferred stock
|
-
|
-
|
-
|
(1,416
|
)
|
-
|
-
|
1,416
|
-
|
-
|
||||||||||||||||||||||||||
Deemed dividend attributable to beneficial conversion feature on
Class Y
convertible preferred stock |
-
|
-
|
-
|
1,416
|
-
|
-
|
(1,416
|
)
|
-
|
-
|
||||||||||||||||||||||||||
Conversion of Class Y convertible preferred stock into common stock
|
-
|
-
|
(2,067,522
|
)
|
(1,416
|
)
|
2,067,522
|
2
|
1,414
|
-
|
-
|
|||||||||||||||||||||||||
Conversion of Series X convertible preferred stock into common stock
|
(430
|
)
|
(333
|
)
|
-
|
-
|
27,296
|
-
|
333
|
-
|
-
|
|||||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
-
|
(7,724
|
)
|
(7,724
|
)
|
|||||||||||||||||||||||||||
Balance at March 31, 2018
|
-
|
$
|
-
|
-
|
$
|
-
|
26,179,302
|
$
|
26
|
$
|
447,587
|
$
|
(442,152
|
)
|
$
|
5,461
|
(1) |
All per share amounts and shares of the Company’s common stock issued and outstanding for all periods have been retroactively adjusted to reflect the one-for-eight reverse stock split which became effective April 28, 2017.
|
|
Three Months Ended March 31
|
|
||||||
|
2018
|
|
2017
|
|
||||
Net loss per share
|
|
|
||||||
Numerator
|
|
|
||||||
Net loss
|
|
$
|
(
7,724
|
)
|
|
$
|
(11,207
|
)
|
Deemed dividend attributable to preferred stock
|
|
|
(1,540
|
)
|
|
|
(2,503
|
)
|
Net loss applicable to common stockholders
|
|
$
|
(
9,264
|
)
|
|
$
|
(13,710
|
)
|
Denominator
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding
|
|
|
22,166,869
|
|
|
|
6,759,567
|
|
Basic and diluted net loss per share
|
|
$
|
(0.4
2
|
)
|
|
$
|
(2.03
|
)
|
Three Months Ended March 31,
|
||||||||
|
2018
|
2017
|
||||||
Total options to purchase common stock
|
6,724,345
|
750,355
|
||||||
Total warrants to purchase common stock
|
18,725,764
|
274,801
|
||||||
Series X convertible preferred stock
|
—
|
30,930
|
||||||
Total
|
25,450,109
|
1,056,086
|
· |
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 require the Company to develop its own assumptions.
|
|
March 31, 2018
|
|||||||||||||||
|
Estimated
Fair Value
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||
|
||||||||||||||||
|
||||||||||||||||
Assets:
|
||||||||||||||||
Money market funds
|
$
|
7,989
|
7,989
|
$
|
—
|
$
|
—
|
|||||||||
Liabilities:
|
||||||||||||||||
Warrant Liability
|
$
|
704
|
$
|
—
|
$
|
—
|
$
|
704
|
|
December 31, 2017
|
|||||||||||||||
|
Estimated
Fair Value
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||
Assets:
|
||||||||||||||||
Money market funds
|
$
|
2,097
|
$
|
2,097
|
$
|
—
|
$
|
—
|
||||||||
Liabilities:
|
||||||||||||||||
Warrant liability
|
$
|
4,457
|
$
|
—
|
$
|
—
|
$
|
4,457
|
|
March 31, 2018
|
|||
Beginning balance at December 31, 2017
|
$
|
4,457
|
||
Decrease in fair value of warrant liability from January 1 to March 31, 2018
|
(3,290
|
)
|
||
Balance reclassified to additional paid-in capital upon exercise of warrants
|
(463
|
)
|
||
Ending balance
|
$
|
704
|
1. |
On the date of issuance, the warrants were not considered indexed to the Company’s own stock because the underlying instruments were not “fixed-for-fixed” due to the exercise price being subject to adjustment in a Stock Combination Event.
|
2. |
The warrants permit the holder to require the Company to settle the warrants for cash in an amount equal to the Black-Scholes value of the warrants in the event of a fundamental transaction, including a sale of the business.
|
March 31, 2018
|
||||
Common stock price
|
$
|
0.32
|
||
Exercise price
|
$
|
1.89
|
||
Expected volatility
|
132.1
|
%
|
||
Dividend yield
|
0
|
%
|
||
Risk-free interest rate
|
2.53
|
%
|
||
Expected term (years)
|
4.08
|
· |
Beneficial Conversion Feature
- Because the conversion price of the shares of Class Y 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
in excess of the amount allocated to the Class Y Preferred Stock for accounting purposes
). The BCF is recorded as a discount to the Class Y Convertible Preferred Stock and is immediately accreted as a deemed preferred stock dividend and, accordingly, an adjustment to net loss to arrive at net loss applicable to common stockholders. During the quarter ended March 31, 2018, the Company recorded a deemed dividend of $1.5 million.
|
Common stock options outstanding
|
6,724,345
|
|||
Common stock warrants outstanding
|
18,725,764
|
|||
Common stock options available for future grant under stock option plan
|
584,257
|
|||
Common stock available for future grant under ESPP plan
|
504,069
|
|||
Total
|
26,538,435
|
Initial Closing
|
Second Closing
|
|||||||
Common stock price
|
$
|
1.72
|
$
|
1.50
|
||||
Exercise price
|
$
|
1.55
|
$
|
1.25
|
||||
Expected volatility
|
110
|
%
|
113
|
%
|
||||
Dividend yield
|
0
|
%
|
0
|
%
|
||||
Risk-free interest rate
|
1.98
|
%
|
2.18
|
%
|
||||
Expected term (years)
|
5.5
|
5.0
|
|
Number of
Options
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual
Life in Years
|
Aggregate
Intrinsic
Value
|
||||||||||||
Balance at December 31, 2017
|
1,066,121
|
$
|
10.04
|
8.68
|
$
|
18
|
||||||||||
Granted
|
6,190,674
|
$
|
1.65
|
|||||||||||||
Exercised
|
—
|
—
|
||||||||||||||
Cancelled and expired
|
(4,257
|
)
|
$
|
30.43
|
||||||||||||
Forfeited
|
(528,283
|
)
|
$
|
1.65
|
||||||||||||
Balance at March 31, 2018
|
6,724,345
|
$
|
2.96
|
9.50
|
$
|
—
|
||||||||||
Exercisable at March 31, 2018
|
2,576,796
|
$
|
4.01
|
9.23
|
$
|
—
|
|
Three Months Ended
March 31,
|
|||||||
|
2018
|
2017
|
||||||
Research and development
|
$
|
1,168
|
$
|
396
|
||||
General and administrative
|
2,098
|
690
|
||||||
Total
|
$
|
3,266
|
$
|
1,086
|
|
Three Months
Ended March 31,
|
|||||||
|
2018
|
2017
|
||||||
Allocated costs:
|
||||||||
Sollpura
|
$
|
5,212
|
$
|
4,701
|
||||
Blisibimod
|
129
|
1,250
|
||||||
Unallocated costs
|
2,127
|
1,850
|
||||||
Total research and development expense
|
$
|
7,468
|
$
|
7,801
|
· |
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.
|
|
Three months ended
March 31,
|
|||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
||||||||||||
Research and development expenses
|
$
|
7,468
|
$
|
7,801
|
$
|
(333
|
)
|
(4
|
)%
|
|
Three Months Ended
March 31,
|
|||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
||||||||||||
General and administrative expenses
|
$
|
3,503
|
$
|
2,903
|
$
|
600
|
21
|
%
|
|
Three Months Ended
March 31,
|
|||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
||||||||||||
Other income (expense)
|
$
|
(43
|
)
|
$
|
(3
|
)
|
$
|
(40
|
)
|
1,333
|
%
|
|||||
Fair value of warrant liability in excess of proceeds
from financing |
—
|
(600
|
)
|
600
|
100
|
%
|
||||||||||
Change in fair value of warrant liability
|
3,290
|
—
|
3,290
|
100
|
%
|
|||||||||||
Total other income (expense)
|
$
|
3,247
|
$
|
(603
|
)
|
$
|
3,850
|
638
|
%
|
|
March 31,
|
|||||||
|
2018
|
2017
|
||||||
Net cash used in operating activities
|
$
|
(9,381
|
)
|
$
|
(14,329
|
)
|
||
Net cash provided by investing activities
|
358
|
—
|
||||||
Net cash provided by financing activities
|
14,913
|
14,138
|
||||||
Total
|
$
|
5,890
|
$
|
(191
|
)
|
|
Payment Due by Period
|
|||||||||||||||||||
Contractual Obligations
|
< 1 year
|
1-3 years
|
3-5 years
|
> 5 years
|
Total
|
|||||||||||||||
Facility Leases
|
$
|
158
|
53
|
$
|
—
|
$
|
—
|
$
|
211
|
· |
exposure to unknown liabilities
;
|
· |
incurrence of substantial debt or dilutive issuances of equity securities to pay for acquisitions
;
|
· |
write-downs of assets or goodwill or impairment charges
;
|
· |
incurrence of amortization expenses
;
|
· |
impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and;
|
· |
inability to retain key employees of our company or any acquired businesses
.
|
· |
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; and
|
· |
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.
|
· |
regulatory authorities may withdraw their approval of or revoke the licenses for 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 or revoke a license;
|
· |
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 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.
|
· |
an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, which is apportioned among these entities according to their market share in certain government healthcare programs;
|
· |
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for branded and generic drugs, respectively;
|
· |
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts to negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
· |
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations, unless the drug is subject to discounts under the 340B drug discount program;
|
· |
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;
|
· |
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
|
· |
expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance;
|
· |
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
· |
new requirements under the federal Physician Payments Sunshine Act for drug manufacturers to report information related to payments and other transfers of value made to physicians and teaching hospitals as well as ownership or investment interests held by physicians and their immediate family members;
|
· |
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
|
· |
creation of the Independent Payment Advisory Board, which, if and when impaneled, will have authority to recommend certain changes to the Medicare program that could result in reduced payments for prescription drugs; and
|
· |
establishment of a Center for Medicare and Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.
|
· |
In 2012, the U.S. Supreme Court heard challenges to the constitutionality of the individual mandate and the viability of certain provisions of the Healthcare Reform Act. The Supreme Court’s decision upheld most of the Healthcare Reform Act and determined that requiring individuals to maintain “minimum essential” health insurance coverage or pay a penalty to the Internal Revenue Service was within Congress’s constitutional taxing authority. However, as a result of tax reform legislation passed in late December 2017, the individual mandate has been eliminated. The long ranging effects of the elimination of the individual mandate on the viability of the ACA are unknown at this time.
|
· |
On January 20, 2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the ACA that would impose a fiscal burden on states or a cost, fee, tax, penalty or regulatory burden on individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices.
|
· |
On October 13, 2017, President Trump signed an Executive Order terminating the cost-sharing subsidies that reimburse insurers under the ACA. Several state Attorneys General filed suit to stop the administration from terminating the subsidies, but their request for a restraining order was denied by a federal judge in California on October 25, 2017.
|
· |
CMS has recently proposed regulations that would give states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces.
|
· |
The federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as Medicare and Medicaid.
|
· |
The federal false claims laws impose criminal and civil penalties, including those from civil whistleblower or qui tam actions pursuant to the federal False Claims Act, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government.
|
· |
The federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information.
|
· |
The federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services.
|
· |
The federal transparency requirements, sometimes referred to as the “Sunshine Act,” under the Patient Protection and Affordable Care Act, require manufacturers of drugs, devices, biologics, and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests.
|
· |
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information.
|
· |
Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.
|
· |
Analogous state laws and regulations, such as state anti-kickback and false claims laws and transparency laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures and drug pricing.
|
· |
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;
|
· |
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; 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.
|
Number
|
|
Description
|
|
|
|
3.1
|
||
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|
|
3.2
|
||
4.1
|
||
#10.1
|
|
|
|
|
|
#10.2
|
|
|
|
|
|
#10.3
|
|
|
#10.4
|
|
|
|
|
|
#10.5
|
|
|
|
|
|
31.1
|
|
|
|
|
|
31.2
|
|
|
|
|
|
32.1
|
|
|
|
|
|
32.2
|
|
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
ANTHERA PHARMACEUTICALS, INC.
|
|
|
|
|
May 15, 2018
|
By:
|
/s/ J. Craig Thompson
|
|
|
J. Craig Thompson
|
|
|
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
|
May 15, 2018
|
By:
|
/s/ May Liu
|
|
|
May Liu
|
|
|
Senior Vice President, Finance and Administration
|
|
|
(Principal Accounting Officer)
|
1 Year Anthera Pharmaceuticals (CE) Chart |
1 Month Anthera Pharmaceuticals (CE) Chart |
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