8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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 4, 2014

Cytomedix, Inc.

(Exact name of registrant as specified in its charter)

______________

Delaware	01-32518	23-3011702
(State or Other Jurisdiction	(Commission	(I.R.S. Employer
of Incorporation)	File Number)	Identification No.)

209 Perry Parkway, Suite 7, Gaithersburg, MD 20877

(Address of Principal Executive Office) (Zip Code)

240-499-2680

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

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:

¨ 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 2.05. Costs Associated with Exit or Disposal Activities

On May 4, 2014, the Board of Directors (the “Board”) of Cytomedix, Inc., a Delaware corporation (the “Company”) approved the Company’s plans to discontinue further funding of the ALDH Bright Cell development program and close its R&D Facility in Durham, NC in May 2014. The foregoing determination was made in light of the preliminary efficacy and safety results at 90 days from the RECOVER-Stroke phase 2 study in patients with neurological damage arising from an ischemic stroke and treated with ALD-401. Observed improvements in the primary endpoint (mean modified Rankin Score or mRS) were not clinically or statistically significant. This decision is consistent with the Company’s ongoing realignment of its commercial operations to focus on the wound care market and is expected to result in annual savings of approximately $4 million.

The Company will undertake reduction of the entire Durham facility workforce and streamlining of general and administrative expenses. In connection with these actions, the Company currently estimates that it will incur total pre-tax exit and disposal costs in the range of $500,000-$600,000, including employee separation costs of approximately $450,000 and other exit and disposal costs of approximately $150,000. The Company expects to record the majority of such employee separation costs during the second quarter of 2014. The Company also leases a 16,300 square foot facility located in Durham, NC, at approximately $20,000 per month and the least term expiring on December 31, 2018. Any such costs and liabilities related to this anticipated closure, including lease termination costs, will be recognized and measured at fair value in the period when such costs are incurred, which will likely be during the balance of 2014. 

As part of the approved actions, the Company continues to explore strategic alternatives for the BrightCell technology. The Company may incur non-cash impairment charges related to intangible and fixed assets, such as facilities and equipment, or amortizing and non-amortizing intangible assets, as a result of such efforts.

At this time, the Company is unable in good faith to make a final determination of an estimate or range of estimates required by paragraphs (b), (c) and (d) of Item 2.05 of Form 8-K with respect to potential charges related to held-for-sale or discontinued operations, asset impairments, or accelerated depreciation and amortization. As permitted by Item 2.05 of Form 8-K, the Company will file an amendment to this Current Report on Form 8-K under Item 2.05 within four business days after it determines any such estimate or range of estimates. Any such charges would not result in any current or future cash expenditures.

Item 8.01 Other Events

On May 5, 2014, the Company issued a press release announcing the foregoing reorganizations of its research and development operations. A copy of this press release is attached hereto as Exhibit 99.1.

The information contained in this Current Report and the attached exhibit contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. While management has based any forward-looking statements contained therein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company’s control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, as may be updated in the Company’s Quarterly Reports on Form 10-Q filed since the Annual Report. Investors should not place any reliance on forward-looking statements as a prediction of actual results.

The information in Exhibit 99.1 is not “filed” pursuant to the Securities Exchange Act of 1934, as amended, and is not incorporated by reference into any Securities Act registration statements. Additionally, the submission of this report on Form 8-K is not an admission as to the materiality of any information in this report that is required to be disclosed solely by Regulation FD.

Item 9.01 Exhibits

99.1 Press release dated May 5, 2014.

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.

Cytomedix, Inc.
By:	/s/ Martin P. Rosendale
	Martin P. Rosendale Chief Executive Officer

Date: May 8, 2014.

EX-99.1

 

CYTOMEDIX ANNOUNCES RESULTS OF RECOVER-STROKE PHASE 2

STUDY; PROVIDES UPDATE ON R&D REORGANIZATION AND ONGOING

LAUNCH INITIATIVES FOR AUTOLOGEL^TM

Results from RECOVER-Stroke Phase 2 Trial Show No Significant Clinical Benefit;

Completion of R&D Restructuring Expected to Lead to Additional Cost Savings;

Continued Strategic Focus on AutoloGel^TM Launch and Building Profitable Wound Care Business

GAITHERSBURG, Maryland – May 5, 2014 – Cytomedix, Inc. (OTCQX: CMXI), a leading developer of biologically active regenerative therapies, and its wholly owned subsidiary, Aldagen, Inc., announced today the preliminary efficacy and safety results at 90 days from the RECOVER-Stroke phase 2 study in patients with neurological damage arising from an ischemic stroke and treated with ALD-401. Observed improvements in the primary endpoint (mean modified Rankin Score or mRS) were not clinically or statistically significant. In light of this outcome, Cytomedix plans to discontinue further funding of the ALDH Bright Cell development program and close its R&D Facility in Durham, NC. The Company remains focused on its commercial launch initiative for AutoloGel^TM with the goal of driving sales in the estimated $3.4 billion U.S. chronic wound market.

“Ischemic stroke is a challenging medical condition with no effective therapeutic products available to help,” said Martin Rosendale, CEO of Cytomedix. “While the observed benefit of ALD-401 in the RECOVER-Stroke trial is disappointing, the ongoing NIH-funded PACE study in patients with peripheral artery disease (PAD) is approximately 30% enrolled and is continuing at a good rate. PAD is a serious medical problem affecting approximately 8 million people in the U.S., and can lead to chronic wounds, amputation, and death.

With the NIH supporting the PACE study, we believe that the planned closure of our Durham facility is a necessary strategic decision for the Company. The elimination of the associated R&D expense will further reduce our cash burn and is in line with our previously announced goal of building a more commercially focused company.”

Results from Phase 2 RECOVER-Stroke Trial and R&D Reorganization

The study results for patients followed 90 days post treatment with ALD 401 include:

· Group mean and categorical change differences in mean modified Rankin Score (mRS) were not different between the ALD-401 and sham treatment groups.

· Secondary endpoints were not different between groups.

· The safety findings at 90 days are consistent with past reviews by the Data Safety Monitoring Board. There have been no serious adverse events attributable to the use of ALD-401, demonstrating good tolerability and safety.

All patients will be followed for one year, and complete efficacy and safety data will be provided to the scientific community.

In light of the foregoing, Cytomedix plans to close its R&D facility in Durham, NC in May 2014. This decision is consistent with the Company’s ongoing realignment of its commercial operations to focus on the wound care market and is expected to result in annual savings of approximately $4 million.

PACE Study with ALD-301 in Peripheral Artery Disease

The ongoing Phase 2 PACE (Patients with Intermittent Claudication Injected with ALDH Bright Cells) study investigating ALD-301 in patients with peripheral artery disease continues to enroll patients. The study is being funded entirely by NHLBI/NIH. Cytomedix retains ownership of the commercial rights to this program and will continue to seek and pursue opportunities that would potentially allow the asset to be monetized and create additional value for shareholders.

Commercialization of AutoloGel for Chronic Wounds

Cytomedix continues to focus heavily on commercial activities and make progress on the launch of AutoloGel under the Coverage with Evidence Development (CED) program. AutoloGel has been cleared by the FDA for use on a variety of exuding wounds and the Company is in the process of launching it, with Medicare coverage and sufficient payment, into the estimated $3.4 billion U.S. chronic wound market. The final payment decision by the Center for Medicare and Medicaid Services (CMS) came into effect on January 1st this year, significantly expanding the coverage for AutoloGel and allowing providers in the outpatient setting to treat a broad patient population with a variety of wounds.

As part of the ongoing commercial expansion, Cytomedix recently announced a number of senior management appointments and is in the process of building out its commercial team.

“We will continue to focus our time and resources on the successful development and implementation of our reimbursement and customer support functions of the AutoloGel System for chronic wounds,” continued Mr. Rosendale. “We have assembled a talented and experienced commercial team, and continue to work with CMS to expand access to AutoloGel within our Medicare National Coverage Decision.”

About Cytomedix

Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for wound care. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds.  For additional information please visit cytomedix.com.

Forward Looking Statements - Safe Harbor Disclaimer

Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’ actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’ ability to predict or control, including among many others, risks and uncertainties related to the Company’s plans to close the Durham, NC facility, the Company’s continuous ability to commercialize on any such technology going forward, the Company’s ability to successfully execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2014, and thereafter, to successfully negotiate with physician offices as anticipated and to realize the anticipated sales growth from such treatments, the likelihood of a favorable CMS determination relating to the reimbursement rates for AutoloGel™, to meet its stroke trial enrollment rates, to successfully realize sales of the Angel Technology resulting in the royalty stream to the Company, the Company’s ability to successfully integrate the Aldagen acquisition, the Company’s ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company’s expectations of favorable future dialogue with potential strategic partners, and its ability to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company’s sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as “believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2013, and other subsequent filings. These filings are available at www.sec.gov.

Contacts:
Cytomedix, Inc.	Investors
Martin Rosendale, Chief Executive Officer	Andrew McDonald
Steven A. Shallcross, EVP/Chief Financial Officer	LifeSci Advisors, LLC
(240) 499-2680	andrew@lifesciadvisors.com
	(646) 597-6987

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