Harvard Apparatus Regenerative Technology, Inc. - Quarter Report: 2013 September (Form 10-Q)

Delaware		45-5210462
(State or Other Jurisdiction of Incorporation or Organization)		(IRS Employer Identification No.)

84 October Hill Road, Holliston, MA		01746
(Address of Principal Executive Offices)		(Zip Code)

Large accelerated filer ¨	Accelerated filer ¨
Non-accelerated filer ¨ (Do not check if a smaller reporting company)	Smaller reporting company x

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														February 24,
		Three months ended						Nine months ended						2009 (inception)
		September 30,						September 30,						to September 30,
		2013			2012			2013			2012			2013
Revenues		$	-		$	-		$	-		$	-		$	-
Cost of product revenues			-			-			-			-			-
Gross profit			-			-			-			-			-
Sales and marketing expenses			28			35			82			91			466
General and administrative expenses			974			634			2,604			1,631			7,185
Research and development expenses			1,058			1,059			3,483			3,025			10,916
Operating expenses			2,060			1,728			6,169			4,747			18,567
Operating loss			(2,060)			(1,728)			(6,169)			(4,747)			(18,567)
Loss before income taxes			(2,060)			(1,728)			(6,169)			(4,747)			(18,567)
Income taxes			-			-			-			-			-
Net loss		$	(2,060)		$	(1,728)		$	(6,169)		$	(4,747)		$	(18,567)

 

 

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								Period from
								February 24, 2009
								(inception) to
		Nine months ended September 30,						September 30,
		2013			2012			2013
Cash flows used in operating activities:
Net loss:		$	(6,169)		$	(4,747)		$	(18,567)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense			514			349			1,422
Depreciation			123			38			203
Changes in operating assets and liabilities:
Prepaid expenses			(33)			-			(33)
Accounts payable			(53)			(26)			126
Accrued and other current liabilities			21			16			253
Net cash used in operating activities			(5,597)			(4,370)			(16,596)
Cash flows used in investing activities:
Additions to property, plant and equipment			(145)			(146)			(663)
Net cash used in investing activities			(145)			(146)			(663)
Cash flows from financing activities:
Investment by Harvard Bioscience			5,742			4,516			17,259
Net cash provided by financing activities			5,742			4,516			17,259
Net increase (decrease) in cash and cash equivalents			-			-			-
Cash and cash equivalents at beginning of the period			-			-			-
Cash and cash equivalents at end of period		$	-		$	-		$	-

 

 

1. Overview and Basis of Presentation

Overview

 

 

 

 

Basis of Presentation

 

 

Harvard Bioscience has historically used a centralized approach to cash management and financing of its operations. Transactions relating to HART have been accounted for through the Harvard Bioscience investment account for HART. Accordingly, none of the cash, cash equivalents or debt at the Harvard Bioscience corporate level has been assigned to HART in the financial statements through September 30, 2013.

 

The unaudited financial statements of HART as of September 30, 2013 and for the three and nine months ended September 30, 2013 and 2012 and for the period from February 24, 2009 (inception) to September 30, 2013 have been prepared by the Company pursuant to the rules and regulations of the SEC for interim financial reporting. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations.

2.	Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements

 

The accounting policies underlying the accompanying unaudited financial statements are those set forth in Note 2 to the financial statements for the year ended December 31, 2012 included in the Company’s Form 10 Registration Statement.

 

(a)	Unaudited Interim Financial Information

The accompanying interim balance sheet as of September 30, 2013 and statements of operations for the three and nine months ended September 30, 2013 and 2012 and for the period from February 24, 2009 (inception) to September 30, 2013 are unaudited. The accompanying interim statements of cash flows for the nine months ended September 30, 2013 and 2012 and for the period from February 24, 2009 (inception) to September 30, 2013 are unaudited. The interim unaudited financial statements have been prepared in accordance with GAAP on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2013, its results of operations for the three and nine months ended September 30, 2013 and 2012 and for the period from February 24, 2009 (inception) to September 30, 2013, and the Company’s statements of cash flows for the nine months ended September 30, 2013 and 2012 and for the period from February 24, 2009 (inception) to September 30, 2013.  The financial data and other information disclosed in these notes related to the three and nine month periods ended September 30, 2013 and 2012 and for the period from February 24, 2009 (inception) to September 30, 2013 are unaudited. The results for the three and nine months ended September 30, 2013 and 2012 and for the period from February 24, 2009 (inception) to September 30, 2013 are not necessarily indicative of results to be expected for the year ending December 31, 2013, any other interim periods or any future year or period.

 

(b)	Recently Issued Accounting Pronouncements

There are no recently issued accounting standards which are not yet effective which the Company believes would materially impact the financial statements.

3.

Liquidity

 

The Company has incurred operating losses and negative cash flow since inception, and had an accumulated deficit of $18.6 million as of September 30, 2013. Since inception, the Company has received funding for operating losses from Harvard Bioscience. The Company is currently investing significant resources in development and commercialization of devices for use by clinicians and researchers in the field of regenerative medicine. The Company expects to continue to incur operating losses and negative cash flows.

 

 

See Note 8 for a discussion of the Separation, initial capitalization and the subsequent spin-off of the Company.

 

4.	Related Party Transactions

 

For each of the periods presented, HART’s operations were fully integrated with Harvard Bioscience, including executive services, finance, treasury, corporate income tax, human resources, legal services and investor relations. The accompanying financial statements reflect the application of certain estimates and allocations of operating expenses and the Company believes the methods used to allocate these operating expenses are reasonable. The allocation methods include time devoted to HART activities, headcount, percentage of operating expenses or other relevant measures. Allocations of expenses for these services were $0.7 million and $1.9 million for the three and nine month periods ended September 30, 2013, respectively. This compares with allocations of expenses for these services of $0.6 million and $1.6 million for the three and nine month periods ended September 30, 2012, respectively. These allocated expenses are reflected in the total operating expenses in the statements of operations, in addition to direct expenses. The Company’s financial statements may not be indicative of the future performance and do not necessarily reflect what the results of operations, financial position and cash flows would have been had the Company operated as an independent, publicly-traded company during the periods presented.

 

Agreements with Harvard Bioscience

5.	Stock-Based Compensation

Stock-based compensation expense for HART represents an allocation from Harvard Bioscience’s stock-based compensation expense for employees and directors whose time has been allocated to HART.

 

Harvard Bioscience maintains its Third Amended and Restated 2000 Stock Option and Incentive Plan (as amended, the “Plan”) for the benefit of certain of its officers, directors and employees. The following disclosure represents the Company’s portion of the Plan maintained by Harvard Bioscience in which the employees and directors participated. All options and awards granted under the Plan consist of Harvard Bioscience common shares. Accordingly, the amounts presented are not necessarily indicative of future performance and do not necessarily reflect the results that the Company would have experienced as an independent, publicly-traded company for the periods presented.

 

Employee options and awards become fully vested over a period of approximately three years and seven months, with the first quarter vesting after approximately seven months of the grant date and the remaining vesting equally over a period of three years thereafter. Options and awards granted to directors become fully vested over periods between one and three years.

 

The fair value of options granted was determined using the Black-Scholes option-pricing model. The determination of fair value on the date of the grant is affected by the grant date market price of Harvard Bioscience common shares and a number of other variables. These variables include, but are not limited to, the expected stock price volatility of Harvard Bioscience common shares over the term of the awards and actual and projected  stock option exercise behaviors. The fair value of restricted stock units was determined by the number of shares granted and the grant date market price of Harvard Bioscience common shares.

     

The compensation expense recognized for all equity-based awards is net of estimated forfeitures and is recognized using the straight-line method over the applicable service period.

 

 

	8

 

The following summarizes the Company's portion of stock option transactions under the Plan from January 1, 2013 through September 30, 2013:

 

 

The following assumptions were used to estimate the fair value of stock options granted during the nine months ended September 30, 2013 and 2012:

 

 

The weighted average fair values of the options granted under the 2000 Plan during the nine months ended September 30, 2013 was $2.64, using the Black Scholes option-pricing model.  Stock-based compensation expense for the three and nine months ended September 30, 2013 and 2012 consisted of stock-based compensation expense related to stock options and RSUs. 

 

Stock-based compensation expense for the three and nine months ended September 30, 2013 and 2012, was allocated as follows:

 

The Company did not capitalize any stock-based compensation.

HART operations were historically included in Harvard Bioscience’s consolidated U.S. federal and certain state income tax returns. The provision for income taxes has been determined as if HART had filed separate tax returns for the periods presented. Accordingly, the effective tax rate of HART in the future years could vary from its historical effective tax rates depending on the future legal structure of HART and related tax elections. The historical deferred tax assets, including the net operating loss and credit carryforwards generated by HART will remain with Harvard Bioscience subsequent to the separation.

 

At September 30, 2013 and December 31, 2012, the Company had deferred tax assets of $7.9 million and $5.0 million, respectively, which principally relate to net operating loss carryforwards. The Company has a full valuation allowance on its deferred tax assets. Significant management judgment is required in determining any valuation allowance recorded against deferred tax assets and liabilities. Due to the Company’s operating results, and its cumulative loss position and uncertainty surrounding its forecasts, the Company concluded that a full valuation allowance was needed to offset its deferred tax assets.

 

From time to time, we may be involved in various claims and legal proceedings arising in the ordinary course of business. There are no such matters pending that we expect to be material in relation to our business, financial condition, results of operations or cash flows.

 

On November 1, 2013, the previously announced spin-off of the Company from Harvard Bioscience was completed. On that date, the Company became an independent company that operates the regenerative medicine business previously owned by Harvard Bioscience. The spin-off was completed through the distribution to Harvard Bioscience stockholders of record of all the shares of common stock of HART (the “Distribution”).  In the Distribution, Harvard Bioscience distributed to its stockholders one share of HART common stock for every four shares of Harvard Bioscience common stock they owned as of the close of business on October 21, 2013, the record date for the Distribution. Fractional shares of HART common stock were not included in the Distribution. Instead, Registrar & Transfer Company aggregated fractional shares into whole shares, and sold the whole shares in the open market and distributed the aggregate net cash proceeds pro rata to each holder who otherwise would have been entitled to receive a fractional share in the Distribution.

 

Effective with the spin-off, Harvard Bioscience contributed $15.0 million in cash to HART to fund our operations. Harvard Bioscience will no longer fund the Company’s operations following the Distribution. Based on the Company’s current operating plan, management believes the $15.0 million cash contribution will be sufficient to fund the Company’s operating expenses, working capital needs and capital expenditures for at least the next 18 months following the Distribution. The Company has based the estimates on assumptions that may prove wrong, and the Company may use available capital resources sooner than expected. Further, the Company’s strategy or business plan may change in the future, possibly changing the rate of spending or need for additional capital. The Company may need to secure future funding through equity offerings, debt financings, government funding, marketing and distribution arrangements and other collaborations or strategic alliances. The Company cannot assure it will be successful in raising additional capital on favorable terms or at all. In addition, to preserve the tax-free treatment to Harvard Bioscience of the Distribution, for the two-year period following the Distribution the Company will be limited in issuing equity securities beyond certain thresholds which may limit its ability to raise additional capital.

 

Immediately following the Distribution, the Company had 30.0 million common shares authorized and 7.7 million common shares issued and outstanding. Additionally, the Company’s Board of Directors has the authority to issue up to 2.0 million shares of preferred stock and to determine the price, privileges and other terms of these shares, and may exercise this authority without any further approval of stockholders.

 

In connection with the spin-off, certain required adjustments were made to the Harvard Bioscience outstanding equity compensation awards under their employee benefit plans.  Each outstanding option to purchase Harvard Bioscience common stock was converted on the date of the Distribution into both an adjusted Harvard Bioscience option to purchase Harvard Bioscience common stock and an option to purchase HART common stock.  Black-Scholes valuation modeling was used to determine the value that each Harvard Bioscience option had lost at the time of the Distribution. To ensure the holder maintained such lost value, 80% of such lost value was provided back to the holder by making appropriate adjustments to the share amount and exercise price of the existing Harvard Bioscience option and 20% of such lost value was provided back to the holder through the issuance of an option to purchase HART common stock. Similar to the adjustment of the existing Harvard Bioscience options, with respect to each unvested Harvard Bioscience restricted stock unit outstanding at the time of the Distribution, such Harvard Bioscience restricted stock units were converted on the date of the Distribution into both an adjusted Harvard Bioscience restricted stock unit and a HART restricted stock unit.  The market prices of Harvard Bioscience and HART common stock were used to determine the value that each Harvard Bioscience restricted stock unit lost at the time of the Distribution and then to ensure the holder maintained such lost value, 80% of such lost value was provided back to the holder by making an appropriate increase of the share amount of the existing Harvard Bioscience restricted stock unit and 20% of such lost value was provided back to the holder through the issuance of a HART restricted stock unit. The share amounts and exercise prices of the adjusted Harvard Bioscience options and HART options, as well as the share amounts of the adjusted Harvard Bioscience restricted stock unit and HART restricted stock unit, were each adjusted and set in a manner to ensure the intrinsic value held by the holder pertaining to the existing Harvard Bioscience award just prior to the Distribution would be maintained immediately following the Distribution and were determined such that tax is not triggered under Section 409A of the Internal Revenue Code.   As part of these required adjustments, the Company issued approximately 0.3 million HART options and approximately 0.02 million HART restricted stock units and Harvard Bioscience issued an additional approximately 1.7 million options and approximately 0.1 million restricted stock units to holders of outstanding Harvard Bioscience equity compensation awards.

 

 

 

Prior to the Distribution, the Company adopted its 2013 Equity Incentive Plan. In November 2013, following the Distribution, the Company issued option grants to its employees and directors totaling approximately 2.0 million options.

 

In connection with the spin-off, on October 31, 2013, the Company entered into various commercial agreements with Harvard Bioscience which contain many of the key provisions related to the Distribution. These agreements include: (i)  a Separation and Distribution Agreement; (ii) an Intellectual Property Matters Agreement; (iii) a Product Distribution Agreement; (iv) a Tax Sharing Agreement; (v) a Transition Services Agreement; and (vi) a Sublease.

 

Harvard Bioscience received a Supplemental Ruling to the Private Letter Ruling dated March 22, 2013 from the IRS to the effect that, among other things, the Separation and related distribution of all of the shares of the Company’s common stock by Harvard Bioscience will qualify as a transaction that is tax-free for U.S. federal income tax purposes under Section 355 and 368(a)(1)(D) of the Internal Revenue Code continuing in effect. The private letter and supplemental rulings and the tax opinion that Harvard Bioscience expects to receive from Burns & Levinson LLP, special counsel to Harvard Bioscience, rely and will rely on certain representations, assumptions and undertakings, including those relating to the past and future conduct of the HART business, and neither the private letter and supplemental rulings nor the opinion would be valid if such representations, assumptions and undertakings were incorrect. Moreover, the private letter and supplemental rulings do not address all the issues that are relevant to determining whether the Distribution will qualify for tax-free treatment. Notwithstanding the private letter and supplemental rulings and opinion, the IRS could determine the Distribution should be treated as a taxable transaction for U.S. federal income tax purposes if, among other reasons, it determines any of the representations, assumptions or undertakings that were included in the request for the private letter and supplemental rulings are false or have been violated or if it disagrees with the conclusions in the opinion that are not covered by the IRS ruling.

 

To preserve the tax-free treatment to Harvard Bioscience of the Separation and Distribution, for the two-year period following the Distribution the Company may be limited, except in specified circumstances, from:

 

 

If the Distribution fails to qualify for tax-free treatment, in general, Harvard Bioscience would be subject to tax as if it had sold the Company’s common stock in a taxable sale for its fair market value, and Harvard Bioscience stockholders who receive shares of HART common stock in the Distribution would be subject to tax as if they had received a taxable Distribution equal to the fair market value of such shares.

 

Under the tax sharing agreement between Harvard Bioscience and the Company, the Company would generally be required to indemnify Harvard Bioscience against any tax resulting from the Distribution to the extent that such tax resulted from (i) an acquisition of all or a portion of our stock or assets, whether by merger or otherwise, (ii) other actions or failures to act by the Company, or (iii) any of the Company’s representations or undertakings being incorrect or violated. The Company’s indemnification obligations to Harvard Bioscience and its subsidiaries, officers and directors are not limited by any maximum amount. If the Company is required to indemnify Harvard Bioscience or such other persons under the circumstances set forth in the tax sharing agreement, the Company may be subject to substantial liabilities.

 

Prior to the Distribution, the Company’s Board of Directors adopted a Shareholder Rights Plan and declared a dividend distribution of one preferred stock purchase right for each outstanding share of the Company’s common stock. Initially, these rights will not be exercisable and will trade with the shares of the Company’s common stock. Under the Shareholder Rights Plan, the rights generally will become exercisable if a person becomes an “acquiring person” by acquiring 20% or more of the common stock of the Company or if a person commences a tender offer that could result in that person owning 20% or more of the common stock of the Company. If a person becomes an acquiring person, each holder of a right (other than the acquiring person) would be entitled to purchase, at the then-current exercise price, such number of shares of preferred stock which are equivalent to shares of the Company’s common stock having a value of twice the exercise price of the right. If the Company is acquired in a merger or other business combination transaction after any such event, each holder of a right would then be entitled to purchase, at the then-current exercise price, shares of the acquiring company’s common stock having a value of twice the exercise price of the right.

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

This Quarterly Report on Form 10-Q contains statements that are not statements of historical fact and are 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 (the “Exchange Act”). The forward-looking statements are principally, but not exclusively, contained in “Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Forward-looking statements include, but are not limited to, statements about management’s confidence or expectations, and our plans, objectives, expectations and intentions that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “goals,” “sees,” “estimates,” “projects,” “predicts,” “intends,” “think,”“potential,” “objectives,” “optimistic,” “strategy,” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that may cause our actual results to differ materially from those in the forward-looking statements include our ability to obtain and maintain regulatory approval for the bioreactors, scaffolds and other devices and product candidates we pursue; the success of our clinical trials and device and product development programs and the number of patients who can be treated with our products; the amount and timing of costs associated with our development of bioreactors, scaffolds and other devices and products; our failure to comply with regulations and any changes in regulations; our ability to access debt and equity markets; unpredictable difficulties or delays in the development of new technology; our collaborators not devoting sufficient time and resources to successfully carry out their duties or meet expected deadlines; our ability to attract and retain qualified personnel and key employees and retain senior management; our inability to operate effectively as a stand-alone, publicly traded company; the actual costs of separation may be higher than expected; the availability and price of acceptable raw materials and components from third-party suppliers; difficulties in obtaining or retaining the management and other human resource competencies that we need to achieve our business objectives; increased competition in the field of regenerative medicine and the financial resources of our competitors; our ability to obtain and maintain intellectual property protection for our device and product candidates; our inability to implement our growth strategy; plus factors described under the heading “Item 1A. Risk Factors” in this Quarterly Report on Form 10-Q or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. We may not update these forward-looking statements, even though our situation may change in the future, unless we have obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.

 

   

 

 

   

 

 

 

 

   

 

 

 

   

Our actual results could differ materially from our forward-looking statements. Our business faces a variety of risks. We describe below what we believe are currently the material risks and uncertainties we face, but they are not the only risks and uncertainties we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business. In addition, past financial performance may not be a reliable indicator of future performance and historical trends should not be used to anticipate results or trends in future periods. If any of the following risks and uncertainties develops into actual events, these events could have a material adverse effect on our business, financial condition or results of operations. In such case, the trading price of our common stock could decline.   The risk factors generally have been separated into three groups: (i) risks relating to our business, (ii) risks relating to the Separation and (iii) risks relating to our common stock. These risk factors should be read in conjunction with the other information in this Quarterly Report on Form 10-Q.

 

 

 

 

 

	22

	·	untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
	·	unanticipated expenditures to address or defend such actions;
	·	customer notifications for repair, replacement, refunds;
	·	recall, detention or seizure of our products;
	·	operating restrictions or partial suspension or total shutdown of production;
	·	withdrawing BLA approvals or PMAs that have already been granted;
	·	withdrawal of the marketing authorization granted by the European Commission or delay in obtaining such marketing authorization;

	23

	·	withdrawal of the CE Certificates of Conformity granted by the notified body or delay in obtaining these certificates;
	·	refusal to grant export approval for our products; and
	·	criminal prosecution.

	24

	25

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	27

	·	significant awards against us;
	·	substantial litigation costs;
	·	injury to our reputation and the reputation of our products;
	·	withdrawal of clinical trial participants; and
	·	adverse regulatory action.

	28

	29

	30

	31

	32

	33

	34

	35

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·      demand and pricing for our products;

  

·      government or private healthcare reimbursement policies;

  

·      physician and patient acceptance of any of our current or future products;

  

·      manufacturing stoppages or delays;

  

·      introduction of competing products or technologies;

  

·      our operating expenses which fluctuate due to growth of our business; and

  

·      timing and size of any new product or technology acquisitions we may complete.

 

  

  

·      the success or failure of surgeries and procedures involving the use our products;

  

·      the success and costs of preclinical and clinical testing and obtaining regulatory approvals or clearances for our products;

  

·      a shift in our investor base;

  

·      our quarterly or annual results of operations, or those of other companies in our industry;

 

·      actual or anticipated fluctuations in our operating results due to factors related to our business;

  

·      changes in accounting standards, policies, guidance, interpretations or principles;

  

·      announcements by us or our competitors of significant acquisitions, dispositions or intellectual property developments or issuances;

  

·      the failure to maintain our NASDAQ listing or failure of securities analysts to cover our common stock after the Distribution;

  

·      changes in earnings estimates by securities analysts or our ability to meet those estimates;

  

·      the operating and stock price performance of other comparable companies; our issuance of equity, debt or other financing instruments after the Distribution.

 

  

·      overall market fluctuations; and

  

·      general economic conditions.

  

  

  

 

 

 

 

 

 

 

 

 

 

 

 

	39

Item 6.	Exhibits
Exhibit Index
31.1+	Certification of Chief Financial Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2+	Certification of Chief Executive Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*	Certification of Chief Financial Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*	Certification of Chief Executive Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS**	XBRL Instance Document
101.SCH**	XBRL Taxonomy Extension Schema Document
101.CAL**	XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB**	XBRL Taxonomy Extension Labels Linkbase Document
101.PRE**	XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF**	XBRL Taxonomy Extension Definition Linkbase Document

+	Filed herewith.
*	This certification shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
**	XBRL (Extensive Business Reporting Language) information is furnished and not filed or a part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections.

   

 

	HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
	By:	/S/ David Green
		David Green
		President and Chief Executive Officer
	By:	/S/ Thomas McNaughton
		Thomas McNaughton
		Chief Financial Officer

 

31.1+	Certification of Chief Financial Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2+	Certification of Chief Executive Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*	Certification of Chief Financial Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*	Certification of Chief Executive Officer of Harvard Apparatus Regenerative Technology, Inc., pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS**	XBRL Instance Document
101.SCH**	XBRL Taxonomy Extension Schema Document
101.CAL**	XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB**	XBRL Taxonomy Extension Labels Linkbase Document
101.PRE**	XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF**	XBRL Taxonomy Extension Definition Linkbase Document

 

+	Filed herewith.
*	This certification shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
**	XBRL (Extensive Business Reporting Language) information is furnished and not filed or a part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections.