8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): May 9, 2017

Repros Therapeutics Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware	001-15281	76-0233274
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

2408 Timberloch Place, Suite B-7
The Woodlands, TX	77380
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (281) 719-3400

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).

¨   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).

¨   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240-14d-2(b)).

¨   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240-13e-4(c)).

Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

On May 11, 2017, Repros Therapeutics Inc. (the “Company”) received a letter from NASDAQ notifying the Company that it is no longer in compliance with the minimum stockholders’ equity requirement for continued listing on the NASDAQ Capital Market. NASDAQ Listing Rule 5550(b)(1) requires listed companies to maintain stockholders’ equity of at least $2.5 million. In the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, the Company reported stockholders’ equity of approximately $1.6 million, which is below the minimum stockholders’ equity required for continued listing pursuant to NASDAQ Listing Rule 5550(b)(1). Further, as of May 11, 2017, the Company does not meet the alternative compliance standards relating to the market value of listed securities or net income from continuing operations and does not comply with the NASDAQ Listing Rules.

This notification has no immediate effect on the Company’s listing on the NASDAQ Capital Market. NASDAQ has provided the Company with 45 calendar days, or until June 26, 2017, to submit a plan to regain compliance with the minimum stockholders’ equity standard. If the Company’s plan to regain compliance is accepted, NASDAQ may grant an extension of up to 180 calendar days from the date of the notification letter, or until November 6, 2017, to evidence compliance.

The Company is presently evaluating various courses of action to regain compliance and intends to timely submit a plan to NASDAQ to regain compliance with the NASDAQ minimum stockholders’ equity standard. However, there can be no assurance that the Company’s plan will be accepted or that if it is, the Company will be able to regain compliance. If the Company’s plan to regain compliance with the minimum stockholders’ equity standard is not accepted or if it is and the Company does not regain compliance by November 7, 2017, or if the Company fails to satisfy another NASDAQ requirement for continued listing, NASDAQ staff could provide notice that the Company’s common stock will become subject to delisting. In such event, NASDAQ rules permit the Company to appeal the decision to reject its proposed compliance plan or any delisting determination to a NASDAQ Hearings Panel. Accordingly, there can be no guarantee that the Company will be able to maintain its NASDAQ listing.

Item 8.01 Other Events.

Termination of ATM Program

On August 9, 2016, the Company entered into an Equity Distribution Agreement (the “Sales Agreement”) with Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to create an at-the-market equity program (the “ATM Program”) under which the Company from time to time may offer and sell shares of its common stock, par value $0.001 per share, having an aggregate offering price of up to $10,000,000 (the “Shares”) through Ladenburg as sales agent. All sales under the ATM Program were required to be made under the Company’s effective shelf registration statement on Form S-3 (File No. 333-197253), which was declared effective by the Securities and Exchange Commission (the “SEC”) on June 23, 2016, and a related prospectus supplement filed with the SEC on August 9, 2016.

Effective May 9, 2017, the Company terminated the Sales Agreement and the related ATM Program.

The Company has decided to terminate the Sales Agreement because it does not intend to utilize the Sales Agreement to raise additional capital. The Company will not incur any termination penalties as a result of its termination of the Sales Agreement.

A description of the terms and conditions of the Sales Agreement is set forth in the Company’s current report on Form 8-K filed with the SEC on August 9, 2016 and incorporated herein by reference.

Proellex® License Agreement with the National Institutes of Health

As previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2016, in 1999, we licensed rights to Proellex® from the National Institutes of Health (“NIH”), under an exclusive, worldwide license in the field of treatment of human endocrinologic pathologies or conditions in steroid-sensitive tissues which expires upon the expiration of the last licensed patent, currently 2017. This license agreement contains numerous detailed performance obligations, with time sensitive dates for compliance, relating to clinical development and commercialization activities required by us or our designated third-party providers, as well as additional financial milestones and royalties. If we fail to achieve the benchmarks specified in the commercial development plan attached to the license agreement or meet payment obligations, the NIH can terminate the license agreement and we lose our rights to develop and commercialize Proellex®. We and the NIH periodically update the commercial development plan.

As of May 2017, the Company had not yet met certain milestones under the license agreement. On May 11, 2017, after discussions with NIH, the Company received a letter from NIH stating that it remains NIH’s intention to re-establish meaningful development timelines with the Company once the Company has received further guidance from the Food and Drug Administration (the “FDA”) on the Company’s clinical path forward for Proellex®. NIH has indicated that it understands that the Company had a guidance meeting with the FDA and is waiting to hear back from the FDA once the agency consult with its internal liver experts. The NIH indicated that, consequently, the NIH does not consider the Company in breach of the license agreement at this time.

Item 9.01 Financial Statements and Exhibits.

The Company has updated its corporate presentation and is filing the corporate presentation as Exhibit 99.1 to this report. These slides contain statements that are “forward-looking statements” subject to the cautionary statement about forward-looking statements set forth therein.

Exhibit Number	Description
99.1	Repros Therapeutics Inc. Slideshow

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

REPROS THERAPEUTICS INC.
By:	/s/ Kathi Anderson
	Kathi Anderson
	Chief Financial Officer

Dated: May 17, 2017

EXHIBIT INDEX

Exhibit Number	Description
99.1	Repros Therapeutics Inc. Slideshow

EX-99.1

Exhibit 99.1

REPROS THERAPEUTICS CORPORATE PRESENTATION MAY 2017 Dedicated to Treating Male and Female Reproductive Disorders

SAFE HARBOR Any statements made by the Company that are not historical facts contained in these slides (or in any oral accompanying discussion) are forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward - looking statements . These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “potential,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should” or similar expressions . These statements are based on assumptions that the Company has made in light of the Company’s experience in the industry, as well as the Company’s perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances . Forward - looking statements include, but are not limited to, those relating to anticipated milestones for Enclomiphene and Proellex ®, the conduct of planned clinical studies and the timing and nature of the results thereof, the markets for the Company’s products and the potential success of the Company in penetrating those markets and that the Company’s need for and use of financial resources . Such statements are based on current expectations that involve a number of known and unknown risks, uncertainties and other factors that may cause actual events to be materially different from those expressed or implied by such forward - looking statements, including the ability to raise additional needed capital on a timely basis in order for it to continue to fund development of its Enclomiphene and Proellex ® programs, the ability to have success in the clinical development of its technologies, the reliability of interim results to predict final study outcomes, and such other risks as are identified in the Company's most recent Annual Report on Form 10 - K and the subsequent quarterly report on Form 10 - Q and in the prospectus supplement and the accompanying prospectus included in the registration statement mentioned below . These documents are available on request from Repros or at www . sec . gov . Repros disclaims any intention or obligation to update or revise any forward - looking statements, whether as a result of new information, future events or otherwise . In this presentation, we rely on and refer to information and statistics regarding the pharmaceutical industry . We obtained this information and these statistics from third - party sources, which we have supplemented where necessary with information from publicly available sources and our own internal estimates . Industry publications and surveys generally state that they have obtained information from sources believed to be reliable, but do not guarantee the accuracy and completeness of such information . While we believe that each of these studies and publications is reliable, we have not independently verified such data, and we make no any representation as to the accuracy of such information . Similarly, we believe our internal research is reliable, but it has not been verified by any independent sources . 2

COMPANY OVERVIEW • Originally founded as Zonagen – an animal health company using technology from Baylor University • IPO 1993 • Key recent developments • Patrick Fourteau named as Chairman of the Board • Larry Dillaha, M.D. named President and CEO • Important patent issuance with coverage until 2027 • FDA meeting to discuss path forward for Proellex ® • European filing for Enclomiphene 3

EXPERIENCED MANAGEMENT TEAM • Larry Dillaha , M.D. – President and CEO (Feb 2017) • Sanofi, Sciele / Shionogi, Insys Therapeutics • History of clinical and regulatory success • Kathi Anderson, CPA – CFO • Joined Repros in 2002 • More than 15 years in biotech, life sciences • Joe Wernicke, M.D., Ph.D. – Chief Medical Officer • 30 years industry experience • Eli Lilly, Cyberonics • Jaye Thompson, PhD - SVP Clinical and Regulatory Affairs • Over 20 years experience in clinical research • Founded Synergos – sold to InVentiv Health 4

PROELLEX ® ( TELAPRISTONE ACETATE) FOR THE TREATMENT OF UTERINE FIBROIDS AND ENDOMETRIOSIS • Licensed from NIH, 1999 • Selective Progesterone Receptor Modulator (SPRM) • No selectivity for glucocorticoid receptor • Need for chronic intermittent dosing • Lead Indications: • Treatment of Uterine Fibroids • Treatment of Endometriosis expected to follow • Strong patent protection • NCE related thru 2021 • Off - Drug Interval thru 2027 5

SELECTIVE PROGESTERONE RECEPTOR MODULATOR (SPRM) • Evolved from Progesterone Antagonists • Mifepristone • Limited use because of high affinity for glucocorticoid receptor over progesterone receptor • Recognizing need for more selective progesterone receptor activity, SPRMs developed • Mixed agonist and antagonist activity at progesterone receptor • Relative activity is tissue specific • Minimizing activity on other steroidal receptors 6

UTERINE FIBROIDS • Benign smooth muscle tumors of uterus ( leiomyomas ) • Most common tumor of female reproductive tract • 20 - 77% of women aged 35 - 55 • Quality of Life often impacted • Heavy menstrual bleeding • Discomfort and pain • Current Therapy • Medications • NSAIDS, OCPs, GnRH agonists, Progestin releasing IUDs • Minimally Invasive Procedures • Uterine artery embolization, myomectomy, ablation • Surgery • Hysterectomy – most common reason for hysterectomy – over half of the 600,000 done annually 7

ENDOMETRIOSIS • Endometrial tissue growing outside the uterus • Infertility – Pain, including pelvic pain • Dyspareunia • Dysmenorrhea • 11% of women aged 15 - 44 • 25 - 40% of all cases of infertility • 71 - 87% of women with chronic pelvic pain • 53% teenagers with dysmenorrhea • Impact on QoL • Current Therapy • Medication • NSAIDs, opioids, OCPs, Lupron, danazol • Surgery • Laproscopic procedures – high rates of recurrence 8

HOW ANTIPROGESTINS LIKE PROELLEX® WORK GnRH agonists and antagonists. These agents: • Block hypothalamus / pituitary axis • Shut down hormonal secretions • Add - back hormonal therapy Proellex ® Hypothalamus Pituitary Endometrial & Uterine Tissue Antiprogestins • Selectively block progesterone activity • Allow tonic hormone secretions - No add - back hormonal therapy required • Potential for chronic intermittent use 9 O O OMe N O Ac CH 3 H 3 C A1

PROELLEX ® EFFECTIVENESS IN PATIENTS 10 AN EFFECTIVE DOSE OF PROELLEX ® STOPS MENSTRUATION IN MAJORITY OF WOMEN Induction of amenorrhea relieves key symptoms of uterine fibroids and endometriosis 0 10 20 30 40 50 60 70 80 90 100 1 mg 3 mg 6 mg 9 mg 12 mg 25 mg 50 mg % of Women with Induced Amenorrhea • Proellex ® induced amenorrhea (no ovulation) • Mimics early follicular phase without progesterone while maintaining tonic estrogen levels Efficacy shown thru wide range of doses

BROAD PATENT POSITION ON PROELLEX ® • Off Drug Interval • Recent issuance of patent ‘074 – expires 2027 • Relates to the use of Selective Progesterone Receptor Modulators (SPRM), in particular Telapristone Acetate (Proellex ® ) or Ulipristal Acetate, with an Off Drug Interval (ODI) for the treatment of estrogen - dependent hyperproliferative uterine conditions, such as uterine fibroids and endometriosis. • NIH NCE patents • Coverage until 2021 11

REGULATORY / DEVELOPMENT HISTORY 12 Full Clinical Hold 2009 Partial Clinical Hold Phase II studies FDA Meeting Await FDA Feedback • Study doses 12mg and lower • Submit protocols • Increased liver monitoring • Doses of 50mg and 25mg • 2 cases of Hy’s Law at 50mg only • 6mg and 12 mg • Uterine Fibroids • Endometriosis • Good efficacy • No evidence of drug induced liver injury • Meeting changed from EOP2 to Guidance • FDA will get internal liver consult • Company will submit additional information • Remain on Partial Clinical Hold

EXPECTED REGULATORY PATH FORWARD FOR PROELLEX ® • Repros has empaneled group of liver experts to review data and provide opinion • Reached agreement with division to accept additional information from Repros, including opinion from company’s liver experts, for submission to FDA internal liver panel • Submit clinical protocol along with supplemental information • FDA feedback may take 2 - 3 months 13

SIGNIFICANT MARKET OPPORTUNITY AND INVESTMENT IN THIS THERAPEUTIC AREA • Ulipristal Acetate • Gedeon Richter product Partnered with Allergan for US market • On market in EU • Esmya 5 mg for Tx of UF • Recently completed phase III • Venus II trial • Publicly stated intent to file NDA in 2H17 • $520mil by 2020 • Vilaprisan • Bayer asset V • Recently completed phase II program • Projected 1 billion euros per year • GnRH Agonists 14

ENCLOMIPHENE FOR THE TREATMENT OF SECONDARY HYPOGONADISM • NDA submitted Jan 2015 • Complete response letter received Nov 2015 • EMA filing under review present in EU market • Opinion date is anticipated in 1Q18 • Actively seeking partnering opportunities ex US 15

REPROS: NEXT STEPS AND MILESTONES • Continue discussions with FDA and obtain feedback to determine future clinical trial program for Proellex ® for Uterine Fibroids and Endometriosis • Submit Proellex ® trial design to FDA • EMA filing under review for Enclomiphene for secondary hypogonadism • New management has experience and successful track record to achieve favorable results with the FDA • Actively seeking partnering opportunities for Proellex ® in the US, global or regional markets • Actively seeking partnering opportunities for Enclomiphene outside of the US • Maximize value from patent position 16