Item 1. Financial Statements
The following unaudited
condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the
United States of America for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation
S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted
in the United States of America for complete financial statements. In the opinion of management, all adjustments (which include
only normal recurring adjustments) considered necessary for a fair statement of the interim periods presented have been included.
The year-end balance sheet data was derived from audited financial statements, but does not include all the disclosures required
by accounting principles generally accepted in the United States of America. Operating results for the three and nine month periods
ended September 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016.
For further information, refer to the financial statements and footnotes thereto included in the Company’s Annual Report on Form
10-K for the year ended December 31, 2015.
REPROS THERAPEUTICS INC.
(A development stage company)
REPROS THERAPEUTICS
INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited and in thousands except share and
per share amounts)
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
10,505
|
|
|
$
|
21,393
|
|
Prepaid expenses and other current assets
|
|
|
158
|
|
|
|
84
|
|
Total current assets
|
|
|
10,663
|
|
|
|
21,477
|
|
Fixed
assets,
net
|
|
|
4
|
|
|
|
8
|
|
Total assets
|
|
$
|
10,667
|
|
|
$
|
21,485
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,815
|
|
|
$
|
1,969
|
|
Accrued expenses
|
|
|
494
|
|
|
|
949
|
|
Total current liabilities
|
|
|
2,309
|
|
|
|
2,918
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (note 5)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ Equity
|
|
|
|
|
|
|
|
|
Undesignated Preferred Stock, $.001 par value, 5,000,000 shares authorized, none issued and outstanding
|
|
|
-
|
|
|
|
-
|
|
Common Stock, $.001 par value, 75,000,000 shares authorized, 25,239,134 and 24,430,461 shares issued, respectively and 25,126,784 and 24,318,111 shares outstanding, respectively
|
|
|
25
|
|
|
|
24
|
|
Additional paid-in capital
|
|
|
325,263
|
|
|
|
322,179
|
|
Cost of treasury stock, 112,350 shares
|
|
|
(1,380
|
)
|
|
|
(1,380
|
)
|
Accumulated deficit
|
|
|
(315,550
|
)
|
|
|
(302,256
|
)
|
Total stockholders’ equity
|
|
|
8,358
|
|
|
|
18,567
|
|
Total liabilities and stockholders’ equity
|
|
$
|
10,667
|
|
|
$
|
21,485
|
|
The accompanying notes are an integral part
of these condensed consolidated financial statements.
REPROS THERAPEUTICS INC.
(A development stage company)
REPROS THERAPEUTICS
INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited and in thousands except per share
amounts)
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues and Other Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
$
|
10
|
|
|
$
|
1
|
|
|
$
|
41
|
|
|
$
|
3
|
|
Total revenues and other income
|
|
|
10
|
|
|
|
1
|
|
|
|
41
|
|
|
|
3
|
|
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
3,182
|
|
|
|
5,506
|
|
|
|
10,191
|
|
|
|
19,277
|
|
General and administrative
|
|
|
997
|
|
|
|
1,100
|
|
|
|
3,144
|
|
|
|
3,647
|
|
Total expenses
|
|
|
4,179
|
|
|
|
6,606
|
|
|
|
13,335
|
|
|
|
22,924
|
|
Net loss
|
|
$
|
(4,169
|
)
|
|
$
|
(6,605
|
)
|
|
$
|
(13,294
|
)
|
|
$
|
(22,921
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share - basic and diluted:
|
|
$
|
(0.17
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(0.55
|
)
|
|
$
|
(0.94
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in loss per share calculation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
24,495
|
|
|
|
24,318
|
|
|
|
24,372
|
|
|
|
24,291
|
|
Diluted
|
|
|
24,495
|
|
|
|
24,318
|
|
|
|
24,372
|
|
|
|
24,291
|
|
The accompanying notes are an integral part
of these condensed consolidated financial statements.
REPROS THERAPEUTICS INC.
(A development stage company)
REPROS THERAPEUTICS
INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
(unaudited and in thousands except share and
per share amounts)
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
Common
Stock
|
|
|
Paid-in
|
|
|
Treasury
Stock
|
|
|
Accumulated
|
|
|
Stockholders’
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Shares
|
|
|
Amount
|
|
|
Deficit
|
|
|
Equity
|
|
Balance at December 31, 2015
|
|
|
24,430,461
|
|
|
$
|
24
|
|
|
$
|
322,179
|
|
|
|
112,350
|
|
|
$
|
(1,380
|
)
|
|
$
|
(302,256
|
)
|
|
$
|
18,567
|
|
Stock based compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
1,491
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,491
|
|
Exercise of 1,333 Series
A warrants to purchase common stock for cash @$0.01 per share
|
|
|
1,333
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Issuance of 807,340 shares of common stock
at a weighted average share price of $2.15, net of offering costs of $145
|
|
|
807,340
|
|
|
|
1
|
|
|
|
1,593
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,594
|
|
Net
loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(13,294
|
)
|
|
|
(13,294
|
)
|
Balance at September
30, 2016
|
|
|
25,239,134
|
|
|
$
|
25
|
|
|
$
|
325,263
|
|
|
|
112,350
|
|
|
$
|
(1,380
|
)
|
|
$
|
(315,550
|
)
|
|
$
|
8,358
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2014
|
|
|
24,388,523
|
|
|
$
|
24
|
|
|
$
|
318,437
|
|
|
|
112,350
|
|
|
$
|
(1,380
|
)
|
|
$
|
(273,064
|
)
|
|
$
|
44,017
|
|
Stock based compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
2,925
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2,925
|
|
Exercise of 37,093 Series
A warrants to purchase common stock for cash @ $0.01 per share
|
|
|
37,093
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Issuance of 4,845 shares
of common stock for the cashless exercise of 15,000 stock options
|
|
|
4,845
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Net
loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(22,921
|
)
|
|
|
(22,921
|
)
|
Balance at September
30, 2015
|
|
|
24,430,461
|
|
|
$
|
24
|
|
|
$
|
321,362
|
|
|
|
112,350
|
|
|
$
|
(1,380
|
)
|
|
$
|
(295,985
|
)
|
|
$
|
24,021
|
|
The accompanying notes are an integral part
of these consolidated financial statements.
REPROS THERAPEUTICS INC.
(A development stage company)
REPROS THERAPEUTICS
INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS
(unaudited and in thousands)
|
|
Nine Months Ended September 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
|
|
Cash Flows from Operating Activities
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(13,294
|
)
|
|
$
|
(22,921
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
4
|
|
|
|
21
|
|
Noncash stock-based compensation
|
|
|
1,491
|
|
|
|
2,925
|
|
Increase in prepaid expenses and other current assets
|
|
|
(74
|
)
|
|
|
(124
|
)
|
Decrease in accounts payable and accrued expenses
|
|
|
(609
|
)
|
|
|
(433
|
)
|
Net cash used in operating activities
|
|
|
(12,482
|
)
|
|
|
(20,532
|
)
|
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of offering costs
|
|
|
1,594
|
|
|
|
-
|
|
Proceeds from a shareholder transaction
|
|
|
-
|
|
|
|
102
|
|
Net cash provided by financing activities
|
|
|
1,594
|
|
|
|
102
|
|
Net decrease in cash and cash equivalents
|
|
|
(10,888
|
)
|
|
|
(20,430
|
)
|
Cash and cash equivalents at beginning of period
|
|
|
21,393
|
|
|
|
46,620
|
|
Cash and cash equivalents at end of period
|
|
$
|
10,505
|
|
|
$
|
26,190
|
|
The accompanying notes are an integral part
of these condensed consolidated financial statements.
REPROS THERAPEUTICS INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
September 30, 2016
(Unaudited)
NOTE 1 – Organization, Operations
and Liquidity
Repros Therapeutics Inc.
(the “Company,” “RPRX,” “Repros,” or “we,” “us” or “our”)
was organized on August 20, 1987. We are a biopharmaceutical company focused on the development of new drugs to treat hormonal
and reproductive system disorders.
Our enclomiphene product
candidate, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We are developing
enclomiphene for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with
secondary hypogonadism exhibit low testosterone levels due to under stimulated testes but they are generally fertile. Enclomiphene
is designed to treat the underlying mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary
hypogonadism. Secondary hypogonadism due to being overweight or obese is the single greatest cause of hypogonadism in general.
On February 2, 2015, we announced that we electronically submitted our New Drug Application (“NDA”) to the Food and
Drug Administration (“FDA”) for enclomiphene. The FDA accepted the NDA for review on April 1, 2015 and later assigned
a Prescription Drug User Fee Act (“PDUFA”) goal date of November 30, 2015. In addition, the Division of Bone, Reproductive and Urologic
Products (the “Division”) of the FDA scheduled an advisory committee meeting to review the NDA for November 3, 2015. However, the
Division subsequently cancelled the scheduled advisory committee meeting due to questions that arose late in the review regarding
the bioanalytical method validation that could affect interpretability of certain pivotal study data. On December 1, 2015, we announced
that we had received a Complete Response Letter (“CRL”) from the FDA. A CRL informs companies that an NDA cannot be approved in its
present form. In the CRL, the FDA stated that, based on recent scientific developments, the design of the enclomiphene Phase 3
studies is no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase 3 study or
studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and
bioanalytical method validation in the Phase 3 program.
Subsequently, on February
4, 2016, the Company attended a meeting with the FDA reviewers and senior leaders to discuss resolution of issues identified during
the NDA review. The meeting covered a broad range of topics surrounding the NDA data as well as emerging agency and expert thinking
regarding the treatment of hypogonadism. The Company believes based on the meeting that the FDA is not closed to considering secondary
hypogonadism as an indication. Additionally, in January 2016, the Company initiated a Phase 2 double-blind, placebo controlled,
proof of concept study, ZA-205, in obese secondary hypogonadal men to assess the impact of enclomiphene on metabolic parameters
and quality of life under a diet and exercise regimen. On August 15, 2016, we reported six month interim results from this study.
Additionally, on September
12, 2016, we reported that we successfully submitted a European centralized marketing authorization application (“MAA”) for enclomiphene
for the treatment of secondary hypogonadism. This MAA was subsequently accepted by the European Medicines Agency (“EMA”) and, as
previously reported, has assigned the United Kingdom as the primary rapporteur and France as the co-rapporteur for the application
review. We expect to receive questions relating to this application by the end of January 2017.
On September 26, 2016,
the Company announced that it will participate in a public Advisory Committee Meeting held by the Bone, Reproductive and Urologic
Drugs Division of the FDA. The purpose of the meeting will be to discuss appropriate clinical trial design features, including
acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or
improving testicular function, including spermatogenesis.
Proellex®, our product
candidate for female reproductive health, is a new chemical entity that acts as a selective blocker of the progesterone receptor
and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. On December 29, 2014,
we announced that we have initiated two Phase 2B studies for low dose Proellex® in the treatment of uterine fibroids and are
currently conducting a Phase 2 study in the treatment of endometriosis. All three of these Proellex® studies were fully enrolled
in January 2016. On April 12, 2016, we announced positive clinical data for the vaginal application of Proellex® in women with
severe menstrual bleeding due to uterine fibroids. Additionally, on May 18, 2016, we announced that oral administration of Proellex®,
at doses of both 6 and 12 mg, achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids.
On September 7, 2016, we announced positive clinical data for the first course of treatment in premenopausal women with confirmed
moderate to severe endometriosis.
Our product development pipeline, with dates
as expected as of the date of this report, is summarized in the table below:
Product Candidate (Indication)
Enclomiphene
|
|
Status
|
|
Next Expected Milestone(s)
|
Secondary Hypogonadism
|
|
MAA accepted October 2016; NDA submitted/Complete Response Letter received
|
|
|
Proellex®
|
|
|
|
|
Uterine Fibroids
|
|
Phase 2
|
|
Complete second course of treatment in a Phase 2B study (oral delivery)
(Q4 2016)
Complete second course of treatment in a Phase 2B study (vaginal
delivery) (Q4 2016)
|
Endometriosis
|
|
Phase 2
|
|
Topline data reported September 2016
|
On
August 9, 2016, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Ladenburg
Thalmann & Co. Inc. (“Ladenburg”), pursuant to which we may issue and sell from time to time through Ladenburg,
as sales agent and/or principal, shares of our common stock having an aggregate offering price of up to $10 million (the “ATM
Shares”). Ladenburg is not required to sell on our behalf any specific number or dollar amount of the ATM Shares, but Ladenburg,
upon acceptance of written instructions from us, agreed to use its commercially reasonable efforts consistent with its customary
trading and sales practices, to sell the ATM Shares up to the amount specified, and otherwise in accordance with the terms of a
placement notice delivered to Ladenburg. We have no obligation to sell any ATM Shares under the Equity Distribution Agreement,
and may at any time suspend sales under the Equity Distribution Agreement, provided that such suspension shall not affect either
party’s obligations with respect to the ATM Shares sold prior to the receipt of notice of such suspension. Ladenburg receives
a commission of 3% of the gross sales price of all ATM Shares sold through it under the Equity Distribution Agreement. The ATM
Shares are issued pursuant to our shelf registration statement on Form S-3, as amended (File No. 333-197253). During the quarter
ended September 30, 2016, we sold 807,340 ATM Shares at a weighted average share price of $2.15
,
for
proceeds of approximately $1.6 million, net of expenses including approximately $52,000 in commissions to Ladenburg. Between October
1, 2016 and November 8, 2016, we sold an aggregate of 298,394 ATM Shares at a weighted average share price of $2.12
,
for
proceeds of approximately $614,000, net of expenses including approximately $19,000 in commissions to Ladenburg.
As of September 30, 2016,
we had accumulated losses of $315.6 million, approximately $10.5 million in cash and cash equivalents, and accounts payable and
accrued expenses of approximately $2.3 million, in the aggregate. We anticipate that our current liquidity will be sufficient to
continue the development of our product candidates and meet our obligations as they become due into the second quarter of 2017.
We continue to explore potential additional financing alternatives, including corporate partnering opportunities, that would provide
sufficient funds to enable us to continue to develop our two product candidates through FDA approval; however, there can be no
assurance that we will be successful in raising any such additional funds on a timely basis or at all. The foregoing matters raise
substantial doubt about our ability to continue as a going concern.
Basis of Presentation
These financial statements
are unaudited; however, in the opinion of management, these statements reflect all adjustments necessary for a fair statement of
the results for the periods reported. All such adjustments are of a normal recurring nature unless disclosed otherwise. These financial
statements, including notes, have been prepared in accordance with the applicable rules of the SEC and do not include all of the
information and disclosures required by U.S. GAAP for complete financial statements.
These interim financial
statements should be read in conjunction with the financial statements and notes thereto included in our 2015 Annual Report on
Form 10-K. The results of operations for the third quarter and first nine months of 2016 are not necessarily indicative of the
results to be expected for the full year.
Recent Accounting Pronouncements
In March 2016, the FASB
issued ASU 2016-09, Compensation—Stock Compensation (ASC Topic 718): Improvements to Employee Share-Based Payment Accounting.
The new standard simplifies the accounting for stock-based compensation, including amendments on how both taxes related to stock-based
compensation and cash payments made to taxing authorities are recorded. ASU 2016-09 is effective for annual reporting periods beginning
on or after December 15, 2016, and interim periods within those annual periods and early application is permitted, with any adjustments
reflected as of the beginning of the fiscal year of adoption. We are currently evaluating the impact of this standard on our consolidated
financial statements.
In February 2016, FASB
issued ASU 2016-02, Leases (ASC Topic 842), which supersedes ASC Topic 840, Leases. The new standard is intended to increase transparency
and comparability of organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information
about leasing arrangements. The new guidance is effective for financial statements issued for annual reporting periods beginning
after December 15, 2018, and early application is permitted. We are currently evaluating the impact of this standard on our consolidated
financial statements.
In November 2015,
the FASB issued ASU No. 2015-17, “Balance Sheet Classification of Deferred Taxes” (“ASU 2015-17”),
which requires entities to present deferred tax assets and deferred tax liabilities as noncurrent in a classified balance sheet.
The ASU simplifies the current guidance in ASC Topic 740, Income Taxes, which requires entities to separately present deferred
tax assets and liabilities as current and noncurrent in a classified balance sheet. ASU 2015-17 is effective for fiscal years beginning
after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted for all entities as
of the beginning of an interim or annual reporting period. The Company expects that this guidance will have no effect on the Consolidated
Financial Statements.
In August 2014, the
FASB issued Accounting Standards Update No. 2014-15, “Presentation of Financial Statements - Going Concern.” The new
standard requires management to evaluate whether there are conditions or events that raise substantial doubt about an entity’s
ability to continue as a going concern for both annual and interim reporting periods. This guidance is effective for us for the
fiscal year ending December 31, 2016 and annual and interim periods thereafter. We have assessed the guidance and its impact on
the Company and made the required disclosures.
In May 2014, the FASB issued
Accounting Standards Update 2014-09, “Revenue from Contracts with Customers” (“ASU 2014-09”). ASU 2014-09
is a comprehensive new revenue recognition model requiring a company to recognize revenue to depict the transfer of goods or services
to a customer at an amount reflecting the consideration it expects to receive in exchange for those goods or services. In adopting
ASU 2014-09, companies may use either a full retrospective or a modified retrospective approach. Additionally, this guidance requires
improved disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with
customers. On July 9, 2015, the FASB voted to delay the effective date of this standard by one year. This deferral resulted in
ASU 2014-09 being effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017,
with early adoption being permitted for annual periods beginning after December 15, 2016. Entities have the option of using either
a full retrospective or a modified retrospective approach to adopt the guidance. The Company is currently assessing the effects
this guidance may have on its consolidated financial statements, as well as the method of transition that the Company will use
in adopting the new standard.
NOTE 2 – Accrued
Expenses
Accrued expenses consist
of the following (in thousands):
|
|
September 30, 2016
|
|
|
December 31, 2015
|
|
|
|
|
|
|
|
|
Research and development costs
|
|
$
|
354
|
|
|
$
|
300
|
|
Personnel related costs
|
|
|
57
|
|
|
|
544
|
|
Other
|
|
|
83
|
|
|
|
105
|
|
Total
|
|
$
|
494
|
|
|
$
|
949
|
|
NOTE 3 – Loss Per Share
Basic loss per share is
computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted loss
per share is computed using the average shares outstanding for the period and applying the treasury stock method to potentially
dilutive outstanding options. In all applicable periods, all potential common stock equivalents were anti-dilutive and, accordingly,
were not included in the computation of diluted loss per share.
The following table presents
information necessary to calculate loss per share for the three and nine month periods ended September 30, 2016 and 2015 (in thousands,
except per share amounts):
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,169
|
)
|
|
$
|
(6,605
|
)
|
|
$
|
(13,294
|
)
|
|
$
|
(22,921
|
)
|
Average common shares outstanding
|
|
|
24,495
|
|
|
|
24,318
|
|
|
|
24,372
|
|
|
|
24,291
|
|
Basic and diluted loss per share
|
|
$
|
(0.17
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(0.55
|
)
|
|
$
|
(0.94
|
)
|
Potential common stock
of 2,792,357 and 3,199,147 common shares underlying stock options and warrants for the periods ended September 30, 2016 and 2015,
respectively, were excluded from the above calculation of diluted loss per share because they were anti-dilutive. Other potential
common stock at September 30, 2015 includes Series A Warrants to purchase 2,502 shares of our common stock at an exercise price
of $0.01 and Series B Warrants to purchase 429,704 shares of our common stock at an exercise price of $2.49 issued in our February
8, 2011 public offering. The Series A and Series B warrants expired on February 8, 2016.
NOTE 4 – Stock-Based Compensation
During the nine month period
ended September 30, 2016, the Compensation Committee of the Company’s Board of Directors approved grants of options to purchase
290,000 shares of our common stock to employees and non-employee directors under the 2011 Equity Incentive Plan. Of the options
granted during the nine month period ended September 30, 2016, 100,000 options vest in three equal annual installments commencing
on the date of grant and continuing on each of the first two anniversaries after the date of grant, 25,000 options vest in equal
monthly installments over the first twelve months after the date of grant and 165,000 options vest in equal annual installments
on the first three year anniversaries after the date of grant. Additionally, during the nine month period ended September 30, 2016,
152,500 options either expired or were forfeited.
NOTE 5 – Commitments
and
Contingencies
Therapeutic uses of our
enclomiphene product candidate are covered in the United States by nine issued U.S. patents and ten pending patent applications.
Foreign coverage of therapeutic uses of our enclomiphene product candidate includes 82 issued foreign patents and 107 foreign
pending patent applications. The issued patents and pending applications relate to methods for treating certain conditions including
the treatment of testosterone deficiency in men, the treatment of diabetes mellitus Type 2, the treatment of metabolic syndrome
and conditions associated therewith, and the treatment of infertility in hypogonadal men. Enclomiphene (the trans-isomer of clomiphene)
is purified from clomiphene citrate. A third party individual holds two issued patents related to the use of anti-estrogen such
as clomiphene citrate and others for use in the treatment of androgen deficiency and disorders related thereto. We requested re-examination
of one of these patents by the U.S. Patent and Trademark Office (“PTO”) based on prior art. The patent holder amended
the claims in the re-examination proceedings, which led the PTO to determine that the amended claims were patentable in view of
those publications under consideration and a re-examination certificate was issued. We subsequently filed a second request for
re-examination by the PTO in light of a number of additional publications. The request was granted and all of the claims were finally
rejected by the PTO in the re-examination. The patent holder appealed the rejections to the PTO Board of Patent Appeals and Interferences
(the “PTO Board”) which ultimately reversed the rejections of several dependent claims in view of those publications
under consideration. The patent holder filed a Notice of Appeal to the Federal Circuit on September 28, 2010 contesting the rejections
maintained by the PTO Board. A decision was rendered by the Court of Appeals for the Federal Circuit on December 12, 2011, affirming
the rejection of the appealed claims. The PTO issued an Ex Parte Reexamination Certificate on April 29, 2013, canceling the rejected
claims and confirming the patentability of the remaining claims. Nevertheless, we believe that our development of enclomiphene
does not infringe any of the remaining claims and that all of the remaining claims are invalid on various grounds including additional
prior art publications. We also believe that the second of these two patents is invalid in view of published prior art not considered
by the PTO. If necessary, we intend to vigorously defend any and all claims that may be brought by the holder of such patents in
a court of competent jurisdiction in order to develop enclomiphene further. Adverse determinations in litigation proceedings could
require us to seek licenses which may not be available on commercially reasonable terms, or at all, or subject us to significant
liabilities, in which case we may not be able to successfully commercialize or out-license enclomiphene until such patents expire
or are otherwise no longer in force.
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations
The following discussion
contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities
Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) that involve risk
and uncertainties. Any statements contained in this quarterly report that are not statements of historical fact may be forward-looking
statements. When we use the words “may,” “anticipates,” “believes,” “plans,” “expects”
and similar expressions, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties
which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking
statements. The following discussion of financial condition should be read in conjunction with the accompanying consolidated financial
statements and related notes.
Repros Therapeutics Inc.
The Company was organized
on August 20, 1987. We are a biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive
system disorders.
We are developing enclomiphene,
a single isomer of clomiphene citrate which is an orally active proprietary small molecule compound. Enclomiphene is for the treatment
of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with secondary hypogonadism exhibit
low testosterone levels due to under stimulated testes but they are generally fertile. Enclomiphene is designed to treat the underlying
mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary hypogonadism. Secondary hypogonadism
due to being overweight or obese is the single greatest cause of hypogonadism in general.
In December 2011, we completed
a Phase 2B study of enclomiphene in men with secondary hypogonadism, but naïve to testosterone treatment, at the recommendation
of the Food and Drug Administration (the “FDA”). Top line results of this study demonstrated that enclomiphene was
generally well tolerated compared to placebo and that there were no drug related serious adverse events that led to discontinuation.
We met with the FDA in May 2012 to discuss the design of pivotal Phase 3 efficacy studies for enclomiphene as well as the components
of the overall drug development program required for a New Drug Application (“NDA”) submission and agreed on registration
requirements for enclomiphene oral therapy for the treatment of secondary hypogonadism. In July 2012, we announced that we reached
an agreement with the FDA for the design of the pivotal efficacy studies for enclomiphene for the treatment of secondary hypogonadism.
The pivotal studies were conducted under a Special Protocol Assessment (“SPA”). We have completed both Phase 3 pivotal
efficacy studies. On March 27, 2013, we announced that the top-line results from our first pivotal Phase 3 study, ZA-301,
met both co-primary endpoints mandated by the FDA, and we announced on September 16, 2013, that we met both co-primary endpoints
in the second pivotal study, ZA-302. Additionally, on September 16, 2013, we announced the results from ZA-300, a six-month safety
study. This study identified no new safety issues. On October 22, 2013, we announced that we received guidance from the FDA instructing
the Company to request a meeting to discuss the adequacy of studies ZA-301 and ZA-302. In addition to this guidance, the FDA further
noted that they would allow us to run head-to-head studies against approved testosterone replacement products. These head-to-head
studies, ZA-304 and ZA-305, were initiated in January 2014 and subsequently completed in September and August 2014, respectively.
Both of these head-to-head studies achieved superiority for both co-primary endpoints and most secondary endpoints as compared
to the approved testosterone replacement product. On October 21, 2014, we announced the results from ZA-303, a 52 week, single-blind,
placebo-controlled Phase 3 study to evaluate the effects on bone mineral density. In this study, no new safety signals were identified,
including no evidence of negative effects on bone mineral density. On February 2, 2015, we announced that we electronically submitted
our NDA to the FDA for enclomiphene. The FDA accepted the NDA for review on April 1, 2015 and later assigned a Prescription Drug
User Fee (“PDUFA”) goal date of November 30, 2015. In addition, the Division of Bone, Reproductive and Urologic Products (the “Division”)
of the FDA scheduled an advisory committee meeting to review the NDA for November 3, 2015. However, the Division subsequently cancelled
the scheduled advisory committee meeting due to questions that arose late in the review regarding the bioanalytical method validation
that could affect interpretability of certain pivotal study data. On December 1, 2015, we announced that we had received a Complete
Response Letter (“CRL”) from the FDA. A CRL informs companies that an NDA cannot be approved in its present form. In the CRL, the
FDA stated that, based on recent scientific developments, the design of the enclomiphene Phase 3 studies is no longer adequate
to demonstrate clinical benefit and recommended that Repros conduct an additional Phase 3 study or studies to support approval
in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation
in the Phase 3 program.
Subsequently, on February
4, 2016, the Company attended a meeting with the FDA reviewers and senior leaders to discuss resolution of issues identified during
the NDA review. The meeting covered a broad range of topics surrounding the NDA data as well as emerging agency and expert thinking
regarding the treatment of hypogonadism. The Company believes based on the meeting that the FDA is not closed to considering secondary
hypogonadism as an indication. Additionally, in January 2016, the Company initiated a Phase 2 study, ZA-205, to explore the benefits
of treating secondary hypogonadism. On August 15, 2016, we reported six month interim results from this study.
Additionally, on September
12, 2016, we reported that we successfully submitted a European centralized marketing authorization application (“MAA”) for enclomiphene
for the treatment of secondary hypogonadism. This MAA was subsequently accepted by the European Medicines Agency (“EMA”) and, as
previously reported, has assigned the United Kingdom as the primary rapporteur and France as the co-rapporteur for the application
review. We expect to receive questions relating to this application by the end of January 2017.
On September 26, 2016,
the Company announced that it will participate in a public Advisory Committee Meeting held by the Bone, Reproductive and Urologic
Drugs Division of the FDA. The purpose of the meeting will be to discuss appropriate clinical trial design features, including
acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or
improving testicular function, including spermatogenesis.
We are also developing
Proellex®, an orally administered selective blocker of the progesterone receptor in women, for the treatment of uterine fibroids
and endometriosis. Uterine fibroids and endometriosis affect millions of women of reproductive age. Proellex® has shown statistically
significant results in previous Phase 2 studies for endometriosis and uterine fibroids. We completed a low dose escalating study
as permitted by the FDA in late 2011, to determine both signals of efficacy and safety for low oral doses of the drug. There was
no evidence of elevations of liver enzymes over baseline, suggesting these lower doses avoid the type of adverse events seen at
much higher doses in earlier studies. On October 8, 2012, we announced that the FDA has agreed to a reclassification of the full
clinical hold to a partial clinical hold on low dose oral Proellex® to allow us to conduct a Phase 2 study in the treatment
of endometriosis. We initiated this study in November 2012 and it was fully enrolled in January 2016. On September 7, 2016, we
announced positive clinical data for the first course of treatment in this Phase 2 study.
On October 31, 2013, the
Company held a meeting with the FDA to discuss the clinical development plan for low dose oral Proellex® in the treatment of
uterine fibroids. During the meeting, the FDA provided guidance for endpoints it believed acceptable for the treatment of uterine
fibroids in an efficacy study and instructed the Company to submit a request for lifting the full clinical hold. The Company has
followed the FDA’s recommendations and submitted the study protocol and the request for the full hold lift. Additionally,
on March 17, 2014, we announced that the FDA indicated that we may proceed to conduct Phase 1 and Phase 2 studies of low dose oral
Proellex® for endometriosis and uterine fibroids while remaining on partial clinical hold. This guidance indicated that the
highest allowed dose will be 12 mg daily. On December 29, 2014, we announced that we have initiated a Phase 2B study for low dose
oral Proellex® in the treatment of uterine fibroids. This study was fully enrolled in January 2016. On May 18, 2016, we announced
that oral administration of Proellex®, at doses of both 6 and 12 mg, achieved significant reduction in excessive menstrual
bleeding, the key symptom of uterine fibroids.
The Company has an
active Investigational New Drug application (“IND”) for the vaginal delivery of Proellex® for the treatment of uterine
fibroids. Since the clinical hold relates only to oral delivery of Proellex®, this IND has no clinical hold issues. In
the first quarter of 2012, we initiated a Phase 2 vaginal administration study for the treatment of uterine fibroids, and
reported final study results in January 2013. We held an end of Phase 2 meeting with the FDA in May 2013, to discuss a Phase
3 study design for the vaginally delivered Proellex as a treatment for uterine fibroids. The FDA recommended that a Phase 2B
study should be conducted prior to commencing a Phase 3 program. On December 29, 2014, we announced that we have initiated a
Phase 2B study for vaginally delivered Proellex® in the treatment of uterine fibroids. This study was fully enrolled in
January 2016. On April 12, 2016, we announced positive clinical data for the vaginal application of Proellex® in women
with severe menstrual bleeding due to uterine fibroids.
Our Research and Development Program
Our product development
pipeline, with milestone dates as expected as of the date of this report, is summarized in the table below:
Product Candidate (Indication)
Enclomiphene
|
|
Status
|
|
Next Expected Milestone(s)
|
Secondary Hypogonadism
|
|
MAA accepted October 2016; NDA submitted/Complete Response Letter received
|
|
|
Proellex®
|
|
|
|
|
Uterine Fibroids
|
|
Phase 2
|
|
Complete second course of treatment in a Phase 2B study (oral delivery)
(Q4 2016)
Complete second course of treatment in a Phase 2B study (vaginal
delivery) (Q4 2016)
|
Endometriosis
|
|
Phase 2
|
|
Topline data reported September 2016
|
On
August 9, 2016, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Ladenburg
Thalmann & Co. Inc. (“Ladenburg”), pursuant to which we may issue and sell from time to time through Ladenburg,
as sales agent and/or principal, shares of our common stock having an aggregate offering price of up to $10 million (the “ATM
Shares”). Ladenburg is not required to sell on our behalf any specific number or dollar amount of the ATM Shares, but Ladenburg,
upon acceptance of written instructions from us, agreed to use its commercially reasonable efforts consistent with its customary
trading and sales practices, to sell the ATM Shares up to the amount specified, and otherwise in accordance with the terms of a
placement notice delivered to Ladenburg. We have no obligation to sell any ATM Shares under the Equity Distribution Agreement,
and may at any time suspend sales under the Equity Distribution Agreement, provided that such suspension shall not affect either
party’s obligations with respect to the ATM Shares sold prior to the receipt of notice of such suspension. Ladenburg receives
a commission of 3% of the gross sales price of all ATM Shares sold through it under the Equity Distribution Agreement. The ATM
Shares are issued pursuant to our shelf registration statement on Form S-3, as amended (File No. 333-197253). During the quarter
ended September 30, 2016, we sold 807,340 ATM Shares at a weighted average share price of $2.15
,
for
proceeds of approximately $1.6 million, net of expenses including approximately $52,000 in commissions to Ladenburg. Between October
1, 2016 and November 8, 2016, we sold an aggregate of 298,394ATM Shares at a weighted average share price of $2.12
,
for
proceeds of approximately $614,000, net of expenses including approximately $19,000 in commissions to Ladenburg.
As of September 30, 2016,
we had accumulated losses of $315.6 million, approximately $10.5 million in cash and cash equivalents, and accounts payable and
accrued expenses of approximately $2.3 million, in the aggregate. We anticipate that our current liquidity will be sufficient to
continue the development of our product candidates and meet our obligations as they become due into the second quarter of 2017.
We continue to explore potential additional financing alternatives, including corporate partnering opportunities, that would provide
sufficient funds to enable us to continue to develop our two product candidates through FDA approval; however, there can be no
assurance that we will be successful in raising any such additional funds on a timely basis or at all. The foregoing matters raise
substantial doubt about our ability to continue as a going concern.
Enclomiphene
Product Overview
We are developing enclomiphene,
a single isomer of clomiphene citrate which is an orally active proprietary small molecule compound. Enclomiphene is for the treatment
of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with secondary hypogonadism exhibit
low testosterone levels due to under stimulated testes but they are generally fertile. Enclomiphene is designed to treat the underlying
mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary hypogonadism. Secondary hypogonadism
due to being overweight or obese is the single greatest cause of hypogonadism in general.
Testosterone is an important
male hormone. Testosterone deficiency in men is linked to several negative physical and mental conditions, including loss of muscle
tone, reduced sexual desire and deterioration of memory and certain other cognitive functions. Testosterone production normally
decreases as men age and this decline can be accelerated by obesity, sometimes leading to testosterone deficiency. The leading
therapy for low testosterone is AndroGel®, a commercially available testosterone replacement cream marketed by AbbVie Inc.
(“AbbVie”) for the treatment of low testosterone, which we believe has had and continues to have significant sales
in North America.
Based on our own clinical
trial screening data, we believe over 70% of men that have low testosterone suffer from secondary hypogonadism, a pituitary defect
which is characterized by suboptimal levels of LH (luteinizing hormone) and FSH (follicle stimulating hormone). LH and FSH are
the pituitary hormones that stimulate testicular testosterone and sperm production, respectively. Men with secondary hypogonadism
can be readily distinguished from those that have primary testicular failure via assessment of the levels of secretions of pituitary
hormones, as men with primary testicular failure experience elevated secretions of pituitary hormones. In secondary hypogonadism,
the low levels of LH and FSH fail to provide adequate hormone signaling to the testes, causing testosterone levels to drop to a
level where we believe pituitary secretions fall under the influence of estrogen, which is enhanced in obese men, thus further
suppressing the testicular stimulation from the pituitary.
Enclomiphene acts centrally
to restore testicular function and, hence, normal testosterone in the body. The administration of exogenous testosterone can restore
serum testosterone levels, but does not restore testicular function and thereby generally leads to the cessation of, or significant
reduction in, sperm production. Enclomiphene, by contrast, restores levels of both LH and FSH, which stimulate testicular testosterone
and sperm production, respectively.
Treatment for Secondary Hypogonadism in Men Wishing to Preserve
Testicular Function (Reproductive Status)
On November 8, 2010, we
held a Type B meeting with the FDA to discuss whether the FDA would review our protocols for a Phase 3 trial of enclomiphene in
men with secondary hypogonadism under an SPA. In the meeting, the FDA recommended that a Phase 2B study in men with secondary hypogonadism
but naïve to testosterone treatment be conducted if we desired the protocols to be reviewed under an SPA. The FDA further
opined that such Phase 2B study would provide for a more solid data base for design of Phase 3 studies and eventual approval of
such studies under an SPA.
We completed the Phase
2B trial which consisted of four arms; placebo, two doses of enclomiphene and topical testosterone. In this study, at baseline
the men exhibited morning testosterone less than 250 ng/dl and there was no statistical difference between the groups in testosterone
at baseline. At the end of the three month dosing period, median morning testosterone levels were placebo (196 ng/dl), 12.5 mg
enclomiphene (432 ng/dl), 25 mg enclomiphene (416 ng/dl) and Testim® (393 ng/dl). A comparison of final median morning testosterone
in all three of the active arms to placebo showed them to be highly statistically different and there was no statistical difference
observed between these active arms. This trial also showed that enclomiphene was able to maintain sperm counts in men being treated
for their low testosterone levels, whereas Testim® resulted in suppressed sperm levels.
On July 9, 2012, we announced
that we reached an agreement with the FDA for the design of the pivotal efficacy studies for enclomiphene for the treatment of
secondary hypogonadism. The pivotal studies were conducted under an SPA. On March 27, 2013, we announced that the top-line
results from our first pivotal Phase 3 study, ZA-301, met both co-primary endpoints mandated by the FDA and we announced on
September 16, 2013, that we met both co-primary endpoints in the second pivotal study, ZA-302.
The 500 subject, six month,
open label safety study, ZA-300, completed enrollment in February 2013 at 28 U.S. clinical sites. On September 16, 2013, we reported
top-line results of this study. Additionally, we completed enrollment into a one year, 150 subject DEXA study, ZA-303, in January
2013 at 10 U.S. clinical sites. On October 21, 2014, we announced that this study identified no new safety signals, including no
evidence of negative effects on bone mineral density.
On October 22, 2013, we
announced that we received guidance from the FDA instructing the Company to request a meeting to discuss the adequacy of studies
ZA-301 and ZA-302. In addition to this guidance, the FDA further noted they would allow us to run head-to-head studies against
approved testosterone replacement products. These head-to-head studies, ZA-304 and ZA-305, were initiated in January 2014 and subsequently
completed in September and August 2014, respectively. Both of these head-to-head studies achieved superiority for both co-primary
endpoints and most secondary endpoints as compared to the approved testosterone replacement product.
On February 2, 2015, we
announced that we electronically submitted our NDA to the FDA for enclomiphene. The FDA accepted the NDA for review on April 1,
2015 and later assigned a PDUFA goal date of November 30, 2015. In addition, the Division of the FDA scheduled an advisory committee meeting to review the NDA for November
3, 2015. However, the Division subsequently cancelled the scheduled advisory committee meeting due to questions that arose late
in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data. On
December 1, 2015, we announced that we had received a CRL from the FDA. A CRL informs companies that
an NDA cannot be approved in its present form. In the CRL, the FDA stated that, based on recent scientific developments, the design
of the enclomiphene Phase 3 studies is no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an
additional Phase 3 study or studies to support approval in the target population. The FDA also noted concerns regarding study entry
criteria, titration and bioanalytical method validation in the Phase 3 program.
Subsequently, on February
4, 2016, the Company attended a meeting with the FDA reviewers and senior leaders to discuss resolution of issues identified during
the NDA review. The meeting covered a broad range of topics surrounding the NDA data as well as emerging agency and expert thinking
regarding the treatment of hypogonadism. The Company believes based on the meeting that the FDA is not closed to considering secondary
hypogonadism as an indication. Additionally, in January 2016, the Company initiated a Phase 2 double-blind, placebo controlled,
proof of concept study, ZA-205, in obese secondary hypogonadal men to assess the impact of enclomiphene on metabolic parameters
and quality of life under a diet and exercise regimen. On August 15, 2016, we reported six month interim results from this study.
Additionally, on September
12, 2016, we reported that we successfully submitted a European centralized MAA for enclomiphene
for the treatment of secondary hypogonadism. This MAA was subsequently accepted by the EMA and, as
previously reported, has assigned the United Kingdom as the primary rapporteur and France as the co-rapporteur for the application
review. We expect to receive questions relating to this application by the end of January 2017.
On September 26, 2016,
the Company announced that it will participate in a public Advisory Committee Meeting held by the Bone, Reproductive and Urologic
Drugs Division of the FDA. The purpose of the meeting will be to discuss appropriate clinical trial design features, including
acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or
improving testicular function, including spermatogenesis.
Unlike testosterone replacement
therapies, enclomiphene maintains the normal daily rhythm of testosterone peaks and valleys. We previously conducted three studies
in which 24 hour testosterone levels were obtained and, unlike topical testosterone, morning testosterone was the maximum concentration
observed, consistent with the normal circadian rhythm in men. These studies provide evidence that one assessment of testosterone
between 8 a.m. and 10 a.m. correlates to the maximum value of testosterone for a given subject on a given day. Additionally, we
conducted one additional 24-hour study which showed that enclomiphene’s action in maintaining the normal rhythm is both
predictable and dose-dependent.
We believe the advantages
of oral delivery, maintenance of testicular function and additional metabolic benefits will be important differentiating factors
for enclomiphene, should it be approved. There can be no assurance, however, that we will be successful in implementing this strategy
or that the FDA will approve our drug for commercial use.
Proellex®
Product Overview
Proellex®, our product
candidate for female reproductive health, is a new chemical entity that acts as a selective blocker of the progesterone receptor
and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. There are currently no
FDA-approved orally administered drug treatments for the long-term treatment of either uterine fibroids or endometriosis. The National
Uterine Fibroids Foundation estimates that 80% of all women in the U.S. have uterine fibroids, and one in four of these women have
symptoms severe enough to require treatment. According to the Endometriosis Association, endometriosis affects 6.3 million women
in the U.S. and Canada and millions more worldwide.
The current standards of
care for uterine fibroids and endometriosis consist of surgery or short-term treatment with gonadotropin-releasing hormone (“GnRH”)
agonists drugs, such as Lupron®. GnRH agonists induce a low estrogen, menopausal-like state and promote bone loss and are not
recommended for use for more than six months.
We have conducted numerous
studies with Proellex® dosing approximately 700 women with the drug. All Proellex® studies completed to date exhibited
strong efficacy signals, whether in uterine fibroids or endometriosis. In a 120 patient study of Proellex® as a treatment of
uterine fibroids conducted in the United States (roughly 40 subjects per arm), both a 12.5 and 25 mg dose of Proellex® were
compared to placebo. In this study each of the 12.5 and 25 mg doses achieved highly statistically significant results when compared
to placebo when menstrual bleeding was assessed (p<0.0001). The two doses also achieved highly statistically significant improvement
in quality of life measures using the Uterine Fibroid Symptom Quality of Life questionnaire developed and validated by Georgetown
University and used in the development of device like treatments of uterine fibroids such as uterine artery embolization. There
was no statistical difference in efficacy measures between the two doses. Importantly, in the Phase 2 U.S. trial a significant
percentage of women stopped menstruating. Proellex® resulted in the induction of amenorrhea (cessation of menses), which we
believe is a strong surrogate signal of efficacy. Over 80% of women on both the 12.5 and 25 mg doses exhibited no menses during
the three month trial, whereas all women on placebo exhibited at least one menses.
Up until the summer of
2009, all side effects exhibited in the studies were considered manageable and the benefit of Proellex® far outweighed the
risk. However, in Phase 3 efficacy and larger Phase 3 safety studies in diverse populations, a small number of subjects exhibited
serious adverse effects associated with elevated liver enzymes. As a result of these findings, we elected to stop the trials and
the FDA subsequently placed Proellex® on full clinical hold. All women that experienced elevated liver enzymes and returned
for follow-up visits returned to baseline conditions with no overnight hospitalization necessary. An analysis of all the subjects
that experienced such serious adverse effects showed that the effect only occurred in a small percentage of subjects that were
exposed to the 50 mg dose of the drug for any period of time. Based on these findings, we petitioned the FDA to allow us to conduct
a low dose study to demonstrate both safety and signals of efficacy in low oral doses of Proellex®, up to 12 mg administered
per day. The FDA upgraded the full clinical hold to a partial hold to allow the low dose study to be conducted. In addition, we
are exploring vaginal delivery as an alternative administrative route to bypass first-pass liver effects and reduce systemic exposure,
which is currently in a Phase 2 study.
Low Dose Oral
Pursuant to the terms of
the partial clinical hold currently in place as a result of the liver toxicity exhibited by Proellex®, the FDA allowed us to
run a single study to test low oral doses of Proellex® for signals of safety and efficacy. The study tested five different
doses of Proellex® (1, 3, 6, 9 and 12 mg), with 1 mg being the first dose tested. Each dose was then compared to placebo with
weekly assessments of liver function during both the placebo and drug period. Subjects were dosed with the active drug for 10 weeks,
which allowed for adequate time to determine the impact of a given dose on trends in liver function. Each dose was tested in up
to 12 different subjects and assessment of pharmacokinetic parameters was obtained at the start of dosing and the end of the dosing
period to determine overall and maximum drug exposure for a given dose. We also monitored changes in menstrual bleeding patterns
and ovulation as well as changes in endometrial thickness. The FDA required that an independent Drug Safety Monitoring Board be
established and that the informed consent clearly state the liver toxicity previously experienced with Proellex®. We have completed
this study and have announced that there was no evidence of elevations of liver enzymes over baseline, suggesting these lower doses
avoid the type of adverse events seen at much higher doses in earlier studies.
On July 16, 2012, we announced
that we held a teleconference with the FDA to discuss the development of low dose oral Proellex® as a treatment for endometriosis.
Subsequently, on October 8, 2012, we announced that the FDA has agreed to reclassify the full clinical hold to a partial clinical
hold on low dose oral Proellex® to allow us to conduct a Phase 2 study in the treatment of endometriosis. We initiated this
60 subject, four month active dosing study in November 2012 and it was fully enrolled in January 2016. On September 7, 2016, we
announced positive clinical data for the first course of treatment in this Phase 2 study.
On October 31, 2013, the
Company held a meeting with the FDA to discuss the clinical development plan for low dose oral Proellex® in the treatment of
uterine fibroids. During the meeting, the FDA provided guidance for endpoints it believed acceptable for the treatment of uterine
fibroids in an efficacy study and instructed the Company to submit a request for lifting the full clinical hold. The Company has
followed the FDA’s recommendations and submitted the study protocol and the request for the full hold lift. Additionally,
on March 17, 2014, we announced that the FDA indicated that we may proceed to conduct Phase 1 and Phase 2 studies of low dose oral
Proellex® for endometriosis and uterine fibroids while remaining on partial clinical hold. This guidance indicated that the
highest allowed dose will be 12 mg daily. On December 29, 2014, we announced that we have initiated a Phase 2B study for low dose
oral Proellex® in the treatment of uterine fibroids. This study was fully enrolled in January 2016. On May 18, 2016, we announced
that oral administration of Proellex®, at doses of both 6 and 12 mg, achieved significant reduction in excessive menstrual
bleeding, the key symptom of uterine fibroids.
Vaginal Administration
We are assessing vaginal
administration of Proellex® to avoid first pass liver effects and achieve higher reproductive tract concentrations of the drug
while minimizing systemic exposure. We reported results from two in vivo animal studies which confirmed reduced maximum circulating
concentrations of the drug when administered vaginally, as well as efficacy signals at substantially lower doses than oral administration.
The Company has an active IND for the vaginal delivery of Proellex® for the treatment of uterine fibroids. Since the clinical
hold relates only to the oral delivery of Proellex®, this IND has no clinical hold issues. In the first quarter of 2012, we
initiated a Phase 2 vaginal administration study for the treatment of uterine fibroids. In January 2013, we reported the final
study results which indicated the 12 mg dose achieved statistically significant improvement in menstrual bleeding, uterine fibroid
symptoms and reduction in fibroid volume even with the low number of subjects enrolled into the study (n=12 @ 12 mg). Based on
these findings, the Company believes the 12 mg dose is appropriate for further development. We held an end of Phase 2 meeting with
the FDA in May 2013, to discuss a Phase 3 study design for the vaginally delivered Proellex as a treatment for uterine fibroids.
The FDA recommended that a Phase 2B study should be conducted prior to commencing a Phase 3 program. On December 29, 2014, we announced
that we have initiated a Phase 2B study for vaginally delivered Proellex® in the treatment of uterine fibroids. This study
was fully enrolled in January 2016. On April 12, 2016, we announced positive clinical data for the vaginal application of Proellex®
in women with severe menstrual bleeding due to uterine fibroids.
Other Products
VASOMAX® has been on
partial clinical hold in the U.S. since 1998, and no further development activities are planned.
Business Strategy
We plan to focus our clinical
program on (i) conducting a Phase 2B study for low dose oral Proellex® in the treatment of uterine fibroids, (ii) conducting
a Phase 2B vaginal administration study for Proellex® in the treatment of uterine fibroids, (iii) conducting a Phase 2 study
for low dose oral Proellex® for the treatment of endometriosis and (iv) conducting a Phase 2 proof of concept study for enclomiphene
for the treatment of secondary hypogonadism. We anticipate that our current liquidity will be sufficient to continue the development
of our product candidates and meet our obligations as they become due into the second quarter of 2017. In the normal course of
business we continue to explore potential corporate partnering opportunities for assistance in the clinical development funding
and commercialization of our products, as appropriate; however, there can be no assurance that an acceptable corporate partnering
opportunity will be successfully completed or that our current liquidity will be sufficient to fund all of our product development
needs.
Corporate Information
We were organized as a Delaware corporation
in August 1987. Our principal executive offices are located at 2408 Timberloch Place, Suite B-7, The Woodlands, Texas,
77380, and our telephone number is (281) 719-3400. We maintain an internet website at www.reprosrx.com. The information
on our website or any other website is not incorporated by reference into this quarterly report and does not constitute a part
of this quarterly report. Our Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and all amendments to such
reports are made available free of charge through the Investor Relations section of our website as soon as reasonably practicable
after they have been filed or furnished with the Securities and Exchange Commission.
General
We have 24 full-time employees.
We utilize the services of contract research organizations, contract manufacturers and various consultants to assist us in performing
clinical and regulatory services for the clinical development of our products. We are substantially dependent on our various contract
groups to adequately perform the activities required to obtain regulatory approval of our products.
We have accumulated net
operating losses through September 30, 2016 and the value of the tax asset associated with these accumulated net operating losses
may be substantially diminished in value due to various tax regulations, including change in control provisions in the tax code.
Additionally, during 2013, the Company completed an analysis of its section 382 limit. Based on this analysis, the Company concluded
that the amount of net operating loss (“NOL”) carryforwards and the credits available to offset taxable income is limited
under section 382. See “Critical Accounting Policies and the Use of Estimates – Income Taxes,” below.
Losses have resulted principally
from costs incurred in conducting clinical trials for our product candidates, in research and development activities related to
efforts to develop our products and from the associated administrative costs required to support those efforts. There can be no
assurance that we will be able to successfully complete the transition from a development stage company to the successful introduction
of commercially viable products. Our ability to achieve profitability will depend on, among other things, successfully completing
the clinical development of our products in a reasonable time frame and at a reasonable cost, obtaining regulatory approvals, establishing
marketing, sales and manufacturing capabilities or collaborative arrangements with others that possess such capabilities, and,
if applicable, continuing to raise sufficient funds to finance our activities. There can be no assurance that we will be able to
achieve profitability.
Critical Accounting Policies and the Use
of Estimates
The preparation of financial
statements in conformity with accounting principles generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities
at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting
period. Actual results could differ from those estimates.
Accrued Expenses
We estimate accrued expenses
as part of our process of preparing financial statements. Examples of areas in which subjective judgments may be required include
costs associated with services provided by contract organizations for clinical trials, preclinical development and manufacturing
of clinical materials. We accrue for costs incurred as the services are being provided by monitoring the status of the trials or
services provided and the invoices received from our external service providers. In the case of clinical trials, a portion of the
estimated cost normally relates to the projected cost to treat a patient in our trials, and we recognize this cost over the estimated
term of the study based on the number of patients enrolled in the trial on an ongoing basis, beginning with patient enrollment.
As actual costs become known to us, we adjust our accruals. To date, our estimates have not differed significantly from the actual
costs incurred. However, subsequent changes in estimates may result in a material change in our accruals, which could also materially
affect our balance sheet and results of operations.
Research and Development
Expenses
Research and development,
or R&D, expenses include salaries and related employee expenses, contracted regulatory affairs activities, insurance coverage
for clinical trials and prior product sales, contracted research and consulting fees, facility costs and internal research and
development supplies. We expense research and development costs in the period they are incurred. These costs consist of direct
and indirect costs associated with specific projects as well as fees paid to various entities that perform research on our behalf.
Stock-Based Compensation
We had one stock-based
compensation plan at September 30, 2016, the 2011 Equity Incentive Plan. Accounting for stock-based compensation generally requires
the recognition of the cost of employee services for stock-based compensation based on the grant date fair value of the equity
or liability instruments issued. We use the Black-Scholes option pricing model to estimate the fair value of our stock options.
Expected volatility is determined using historical volatilities based on historical stock prices for a period equal to the expected
term. The expected volatility assumption is adjusted if future volatility is expected to vary from historical experience. The expected
term of options represents the period of time that options granted are expected to be outstanding and falls between the options’
vesting and contractual expiration dates. The Company’s historical stock option exercise experience does not provide a reasonable
basis upon which to estimate expected term. As such, the simplified method was used to calculate the expected term. The risk-free
interest rate is based on the yield at the date of grant of a zero-coupon U.S. Treasury bond whose maturity period equals the option’s
expected term.
Income Taxes
Our losses from inception
to date have resulted principally from costs incurred in conducting clinical trials and in research and development activities
related to efforts to develop our products and from the associated administrative costs required to support those efforts. We have
recorded a deferred tax asset for our NOLs; however, as the Company has incurred losses since inception, and since there is no
certainty of future profits, a valuation allowance has been provided in full on our deferred tax assets in the accompanying consolidated
financial statements. Additionally, during 2013, the Company completed an analysis of its section 382 limit. Based on this analysis,
the Company concluded that the amount of NOL carryforwards and the credits available to offset taxable income is limited under
section 382. Accordingly, if the Company generates taxable income in any year in excess of its then annual limitation, the Company
may be required to pay federal income taxes even though it has unexpired NOL carryforwards. Additionally, because U.S. tax laws
limit the time during which NOLs and tax credit carryforwards may be applied against future taxable income and tax liabilities,
the Company may not be able to take full advantage of its NOLs and tax credit carryforwards for federal income tax purposes. Future
public and private stock placements may create additional limitations on the Company’s NOLs, credits and other tax attributes.
Recent Accounting Pronouncements
In March 2016, the FASB
issued ASU 2016-09, Compensation—Stock Compensation (ASC Topic 718): Improvements to Employee Share-Based Payment Accounting.
The new standard simplifies the accounting for stock-based compensation, including amendments on how both taxes related to stock-based
compensation and cash payments made to taxing authorities are recorded. ASU 2016-09 is effective for annual reporting periods beginning
on or after December 15, 2016, and interim periods within those annual periods and early application is permitted, with any adjustments
reflected as of the beginning of the fiscal year of adoption. We are currently evaluating the impact of this standard on our consolidated
financial statements.
In February 2016, FASB
issued ASU 2016-02, Leases (ASC Topic 842), which supersedes ASC Topic 840, Leases. The new standard is intended to increase transparency
and comparability of organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information
about leasing arrangements. The new guidance is effective for financial statements issued for annual reporting periods beginning
after December 15, 2018, and early application is permitted. We are currently evaluating the impact of this standard on our consolidated
financial statements.
In November 2015,
the FASB issued ASU No. 2015-17, “Balance Sheet Classification of Deferred Taxes” (“ASU 2015-17”),
which requires entities to present deferred tax assets and deferred tax liabilities as noncurrent in a classified balance sheet.
The ASU simplifies the current guidance in ASC Topic 740, Income Taxes, which requires entities to separately present deferred
tax assets and liabilities as current and noncurrent in a classified balance sheet. ASU 2015-17 is effective for fiscal years beginning
after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted for all entities as
of the beginning of an interim or annual reporting period. The Company expects that this guidance will have no effect on the Consolidated
Financial Statements.
In August 2014, the
FASB issued Accounting Standards Update No. 2014-15, “Presentation of Financial Statements - Going Concern.” The new
standard requires management to evaluate whether there are conditions or events that raise substantial doubt about an entity’s
ability to continue as a going concern for both annual and interim reporting periods. This guidance is effective for us for the
fiscal year ending December 31, 2016 and annual and interim periods thereafter. We have assessed the guidance and its impact on
the Company and made the required disclosures.
In May 2014, the FASB issued
Accounting Standards Update 2014-09, “Revenue from Contracts with Customers” (“ASU 2014-09”). ASU 2014-09
is a comprehensive new revenue recognition model requiring a company to recognize revenue to depict the transfer of goods or services
to a customer at an amount reflecting the consideration it expects to receive in exchange for those goods or services. In adopting
ASU 2014-09, companies may use either a full retrospective or a modified retrospective approach. Additionally, this guidance requires
improved disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with
customers. On July 9, 2015, the FASB voted to delay the effective date of this standard by one year. This deferral resulted in
ASU 2014-09 being effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017,
with early adoption being permitted for annual periods beginning after December 15, 2016. Entities have the option of using either
a full retrospective or a modified retrospective approach to adopt the guidance. The Company is currently assessing the effects
this guidance may have on its consolidated financial statements, as well as the method of transition that the Company will use
in adopting the new standard.
Results of Operations
Comparison
of the three and nine month periods ended September 30, 2016 and 2015
Revenues and Other Income
Total revenues and other
income increased to $10,000 for the three month period ended September 30, 2016 as compared to $1,000 for the same period in the
prior year. Total revenue and other income increased to $41,000 for the nine month period ended September 30, 2016 as compared
to $3,000 for the same period in the prior year. All revenue in both periods was from interest income, and the increase was primarily
due to higher yields for the three and nine month period ended September 30, 2016 as compared to the comparable periods in the
prior year.
Research and Development
Expenses
R&D expenses include
contracted services relating to our clinical product development activities which include preclinical studies, clinical trials,
expenses associated with our patent portfolio, regulatory affairs, including FDA filing fees, and bulk manufacturing scale-up activities
and bulk active ingredient purchases for preclinical and clinical trials primarily relating to our two products in clinical development,
which are enclomiphene and Proellex®. Research and development expenses also include internal operating expenses relating to
our general research and development activities. R&D expenses decreased 42%, or $2.3 million, to $3.2 million for the three
month period ended September 30, 2016, as compared to $5.5 million for the same period in the prior year. Our primary R&D expenses
for the three month periods ended September 30, 2016 and 2015 are shown in the following table (in thousands):
|
|
Three months ended
September 30,
|
|
|
|
|
|
|
|
Research and Development
|
|
2016
|
|
|
2015
|
|
|
Variance
|
|
|
Change (%)
|
|
Enclomiphene clinical development
|
|
$
|
992
|
|
|
$
|
2,203
|
|
|
$
|
(1,211
|
)
|
|
|
(55
|
)%
|
Proellex® clinical development
|
|
|
769
|
|
|
|
1,294
|
|
|
|
(525
|
)
|
|
|
(41
|
)%
|
Payroll and benefits
|
|
|
663
|
|
|
|
1,077
|
|
|
|
(414
|
)
|
|
|
(38
|
)%
|
Operating and occupancy
|
|
|
758
|
|
|
|
932
|
|
|
|
(174
|
)
|
|
|
(19
|
)%
|
Total
|
|
$
|
3,182
|
|
|
$
|
5,506
|
|
|
$
|
(2,324
|
)
|
|
|
(42
|
)%
|
R&D expenses related
to the clinical development of enclomiphene decreased 55%, or approximately $1.2 million, for the three month period ended September
30, 2016 as compared to the prior year period, primarily due to the submission of the NDA to the FDA in the first quarter of 2015.
In January 2016, the Company initiated a Phase 2 double-blind, placebo controlled, proof of concept study, ZA-205. R&D expenses
related to the clinical development of Proellex® decreased 41%, or approximately $525,000, from the 2015 period to the 2016
period, due to decreased expenses associated with our ongoing Phase 2B clinical trials for the treatment of uterine fibroids.
Payroll and benefits expenses
decreased 38%, or approximately $414,000, to $663,000 for the three month period ended September 30, 2016 as compared to $1.1 million
for the same period in the prior year. Included in payroll and benefits expense is a charge for non-cash stock-based compensation
of $158,000 for the three month period ended September 30, 2016 as compared to a charge of $476,000 for the same period in the
prior year. Additionally, salaries for the three month period ended September 30, 2016 were $414,000 as compared to $512,000 for
the same period in the prior year.
Operating and occupancy
expenses decreased 19%, or approximately $174,000, to $758,000 for the three month period ended September 30, 2016 as compared
to $932,000 for the same period in the prior year, primarily due to decreased legal expenses.
R&D expenses decreased
47%, or approximately $9.1 million, to $10.2 million for the nine month period ended September 30, 2016, as compared to $19.3 million
for the same period in the prior year. Our primary R&D expenses for the nine month periods ended September 30, 2016 and 2015
are shown in the following table (in thousands):
|
|
Nine months ended
September 30,
|
|
|
|
|
|
|
|
Research and Development
|
|
2016
|
|
|
2015
|
|
|
Variance
|
|
|
Change (%)
|
|
Enclomiphene clinical development
|
|
$
|
3,173
|
|
|
$
|
8,637
|
|
|
$
|
(5,464
|
)
|
|
|
(63
|
)%
|
Proellex® clinical development
|
|
|
2,915
|
|
|
|
3,473
|
|
|
|
(558
|
)
|
|
|
(16
|
)%
|
Payroll and benefits
|
|
|
2,085
|
|
|
|
3,933
|
|
|
|
(1,848
|
)
|
|
|
(47
|
)%
|
Operating and occupancy
|
|
|
2,018
|
|
|
|
3,234
|
|
|
|
(1,216
|
)
|
|
|
(38
|
)%
|
Total
|
|
$
|
10,191
|
|
|
$
|
19,277
|
|
|
$
|
(9,086
|
)
|
|
|
(47
|
)%
|
For the nine month period
ended September 30, 2016, as compared to the same period in 2015, R&D expenses related to the clinical development of enclomiphene
decreased 63%, or approximately $5.5 million, primarily due to the completion of all Phase 3 clinical trials, partially offset
by the payment of $2.3 million to the FDA associated with the submission of our NDA for the product candidate in 2015. R&D
expenses related to the clinical development of Proellex® decreased 16%, or approximately $558,000, due to decreased expenses
associated with our Phase 2B clinical trials for the treatment of uterine fibroids.
Payroll and benefits expenses
decreased 47%, or approximately $1.8 million, to $2.1 million for the nine month period ended September 30, 2016, as compared to
$3.9 million for the same period in the prior year. Included in payroll and benefits expense is a charge for non-cash stock-based
compensation of $527,000 for the nine month period ended September 30, 2016, as compared to a charge of $1.6 million for the same
period in the prior year. Additionally, salaries for the nine month period ended September 30, 2016 were $1.3 million, as compared
to $2.0 million for the same period in the prior year. Salary expense for the nine month period ended September 30, 2015 included
a bonus awarded to the R&D personnel in the amount of $338,000 upon the FDA’s acceptance of the NDA for enclomiphene.
Operating and occupancy
expenses decreased 38%, or approximately $1.2 million, to $2.0 million for the nine month period ended September 30, 2016, as compared
to $3.2 million for the same period in the prior year, primarily due to decreased legal expenses.
To date through September
30, 2016 we have incurred approximately $73.1 million for the development of enclomiphene and approximately $70.5 million for the
development of Proellex®. These accumulated costs exclude any internal operating expenses and expenses associated with the
patent portfolio.
General and Administrative
Expenses
General and administrative
(“G&A”) expenses decreased 9%, or approximately $103,000, to $997,000 for the three month period ended September
30, 2016 as compared to $1.1 million for the same period in the prior year. Our primary G&A expenses for the three month periods
ended September 30, 2016 and 2015 are shown in the following table (in thousands):
|
|
Three months ended
September 30,
|
|
|
|
|
|
|
|
General and Administrative
|
|
2016
|
|
|
2015
|
|
|
Variance
|
|
|
Change (%)
|
|
Payroll and benefits
|
|
$
|
587
|
|
|
$
|
695
|
|
|
$
|
(108
|
)
|
|
|
(16
|
)%
|
Operating and occupancy
|
|
|
410
|
|
|
|
405
|
|
|
|
5
|
|
|
|
1
|
%
|
Total
|
|
$
|
997
|
|
|
$
|
1,100
|
|
|
$
|
(103
|
)
|
|
|
(9
|
)%
|
G&A payroll and benefits
expenses include salaries, bonuses, non-cash stock-based compensation expense and fringe benefits. Included in payroll and benefits
expense is a charge for non-cash stock-based compensation of $296,000 for the three month period ended September 30, 2016 as compared
to a charge of $407,000 for the same period in the prior year. Additionally, salaries for the three month period ended September
30, 2016 were $257,000 as compared to $256,000 for the same period in the prior year.
G&A operating and occupancy
expenses, which include expenses to operate as a public company, remained relatively constant at $410,000 for the three month period
ended September 30, 2016 as compared to $405,000 for the same period in the prior year.
G&A expenses decreased
14%, or approximately $503,000, to $3.1 million for the nine month period ended September 30, 2016, as compared to $3.6 million
for the same period in the prior year. Our primary G&A expenses for the nine month periods ended September 30, 2016 and 2015
are shown in the following table (in thousands):
|
|
Nine months ended
September 30,
|
|
|
|
|
|
|
|
General and Administrative
|
|
2016
|
|
|
2015
|
|
|
Variance
|
|
|
Change (%)
|
|
Payroll and benefits
|
|
$
|
1,843
|
|
|
$
|
2,284
|
|
|
$
|
(441
|
)
|
|
|
(19
|
)%
|
Operating and occupancy
|
|
|
1,301
|
|
|
|
1,363
|
|
|
|
(62
|
)
|
|
|
(5
|
)%
|
Total
|
|
$
|
3,144
|
|
|
$
|
3,647
|
|
|
$
|
(503
|
)
|
|
|
(14
|
)%
|
G&A payroll and benefits
expenses include salaries, bonuses, non-cash stock-based compensation expense and fringe benefits. Included in payroll and benefits
expense is a charge for non-cash stock-based compensation of $963,000 for the nine month period ended September 30, 2016, as compared
to a charge of $1.3 million for the same period in the prior year. Additionally, salaries for the nine month period ended September
30, 2016 were $771,000, as compared to $847,000 for the same period in the prior year. Salary expense for the nine month period
ended September 30, 2015 included a bonus awarded to the G&A personnel in the amount of $80,000 upon the FDA’s acceptance
of the NDA for enclomiphene.
G&A operating and occupancy
expenses, which include expenses to operate as a public company, decreased 5%, or approximately $62,000, to $1.3 million for the
nine month period ended September 30, 2016, as compared to $1.4 million for the same period in the prior year primarily due to
a decrease in professional services expense.
Off-Balance Sheet Arrangements
As of September 30, 2016,
we did not have any off-balance sheet arrangements.
Liquidity and Capital Resources
Since our inception, we
have financed our operations primarily with proceeds from private placements and public offerings of equity securities and with
funds received under collaborative agreements.
On
August 9, 2016, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Ladenburg
Thalmann & Co. Inc. (“Ladenburg”), pursuant to which we may issue and sell from time to time through Ladenburg,
as sales agent and/or principal, shares of our common stock having an aggregate offering price of up to $10 million (the “ATM
Shares”). Ladenburg is not required to sell on our behalf any specific number or dollar amount of the ATM Shares, but Ladenburg,
upon acceptance of written instructions from us, agreed to use its commercially reasonable efforts consistent with its customary
trading and sales practices, to sell the ATM Shares up to the amount specified, and otherwise in accordance with the terms of a
placement notice delivered to Ladenburg. We have no obligation to sell any ATM Shares under the Equity Distribution Agreement,
and may at any time suspend sales under the Equity Distribution Agreement, provided that such suspension shall not affect either
party’s obligations with respect to the ATM Shares sold prior to the receipt of notice of such suspension. Ladenburg receives
a commission of 3% of the gross sales price of all ATM Shares sold through it under the Equity Distribution Agreement. The ATM
Shares are issued pursuant to our shelf registration statement on Form S-3, as amended (File No. 333-197253). During the quarter
ended September 30, 2016, we sold 807,340 ATM Shares at a weighted average share price of $2.15
,
for
proceeds of approximately $1.6 million, net of expenses including approximately $52,000 in commissions to Ladenburg. Between October
1, 2016 and November 8, 2016, we sold an aggregate of 298,394ATM Shares at a weighted average share price of $2.12
,
for
proceeds of approximately $614,000, net of expenses including approximately $19,000 in commissions to Ladenburg.
Our primary use of cash
to date has been in operating activities to fund research and development, including preclinical studies and clinical trials, and
general and administrative expenses. We had cash and cash equivalents of approximately $10.5 million as of September 30, 2016 as
compared to $21.4 million as of December 31, 2015. All cash and cash equivalents as of September 30, 2016 and December 31, 2015
were held in an account backed by U.S. government securities.
Net
cash of approximately $12.5 million and $20.5 million was used in operating activities during the nine month periods ended September
30, 2016 and 2015, respectively. The major use of cash for operating activities for the nine month period ended September 30, 2016
was to fund our clinical development programs and associated administrative costs. No cash was used in investing activities during
the nine month period ended September 30, 2016.
Cash provided by financing activities for
the nine month period ended September 30, 2016 was approximately $1.6 million due to the 807,340 ATM Shares sold at a weighted
average share price of $2.15, net of related expenses.
We have experienced negative
cash flows from operations since inception. We will require substantial funds for R&D, including preclinical studies and clinical
trials of our product candidates, and to commence sales and marketing efforts, if appropriate, if the FDA or other regulatory approvals
are obtained. Based on our current and planned clinical activities, we believe that our current liquidity will be sufficient to
continue the development of our product candidates and meet our obligations as they become due into the second quarter of 2017.
It is possible that our clinical trial activities will be more costly and take longer than we anticipate; accordingly, there can
be no assurance that additional capital will not be necessary prior to the time anticipated. Our capital requirements will depend
on many factors, which are discussed in detail in “Item 1A., Risk Factors” of Form 10-K for the fiscal year ended December
31, 2015. The uncertainties relating to the foregoing matters raise substantial doubt about our ability to continue as a going
concern.
Our results of operations
may vary significantly from quarter to quarter and year to year, and depend on, among other factors, our ability to raise additional
capital on acceptable terms or at all, our ability to be successful in our clinical trials, the regulatory approval process in
the United States and other foreign jurisdictions and the ability to complete strategic licenses and product development agreements.
The timing of our revenues may not match the timing of our associated product development expenses. To date, R&D expenses have
usually exceeded revenue in any particular period and/or fiscal year.