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| 8-K - 8-K - Tobira Therapeutics, Inc. | d815641d8k.htm |
Exhibit 99.1
Regado Biosciences Announces Third Quarter 2014 Financial Results and Provides Corporate Update
Conference Call and Webcast, November 6, 2014, at 8:30 a.m. EST
Basking Ridge, N.J. – November 5, 2014 — Regado Biosciences, Inc. (Nasdaq: RGDO), today announced its third quarter 2014 financial results. A conference call and webcast to discuss the results will be held tomorrow, November 6, 2014, at 8:30 a.m. EST.
THIRD QUARTER 2014 FINANCIAL SUMMARY
Cash and cash equivalents at September 30, 2014, totaled $61.8 million compared to $30.8 million at December 31, 2013. Regado’s net loss for the quarter ended September 30, 2014, was $21.1 million, or a net loss of $.59 per share, as compared to a net loss of $11.4 million, or a net loss of $1.43 per share, for the corresponding period in 2013 on both a basic and fully diluted basis.
Research and development expenses for the third quarter of 2014 were $17.7 million, compared to $9.6 million for the corresponding period in 2013. The increase in research and development expenses was primarily driven by the REGULATE-PCI clinical trial, which began in the third quarter of 2013. The clinical trial expenses for the quarter included site trial activities, data collection, Data and Safety Monitoring Board (DSMB) support and initial trial shutdown expenses. The increase also includes $0.7 million of restructuring charges associated with the reduction in force that was announced September 24, 2014. A write-down of clinical assets totaling $8.9 million is included in the third quarter 2014 results. The company has terminated the REGULATE-PCI trial and is in the process of closing down all associated activities.
General and administrative expenses for the third quarter of 2014 were $3.2 million, compared to $1.6 million for the corresponding period in 2013. The increase in general and administrative expenses included $1.1 million of restructuring charges associated with the reduction in force.
Corporate Updates
| • | REGULATE-PCI – On August 25, 2014, the Company announced the permanent termination of enrollment in its REGULATE-PCI Phase 3 trial for its lead program, Revolixys™ Kit. The decision was made based on a recommendation from the |
| trial’s DSMB following their analysis of the data from the first approximately 3,250 patients enrolled in what was intended to be a 13,200-patient trial comparing the safety and efficacy of Revolixys Kit with bivalirudin. |
| • | Restructuring – On September 24, 2014, the Company announced a workforce reduction that commenced during the third quarter of 2014 and will be completed in the fourth quarter of 2014. This restructuring is associated with the termination of the REGULATE-PCI trial. |
| • | Engagement of Bankers – The Company announced the engagement of MTS Health Partners and Cowen & Co. to serve as strategic advisors in helping to identify strategic alternatives to maximize shareholder value. |
| • | Change in Executive Management – On October 10, 2014, the Company announced the appointment of Michael A. Metzger, president of Regado, to the additional post of chief executive officer and as a member of the Board of Directors. Mr. Metzger previously served as president and chief operating officer of Regado. He replaces David J. Mazzo, Ph.D., who resigned from the Company. |
CONFERENCE CALL INFORMATION
Interested participants and investors may access the conference call by dialing (888) 347-1165 for domestic callers or (412) 902-4276 for international callers. The conference call will be webcast live under the investor relations section of the Regado website at www.regadobio.com and will be archived there for 60 days following the call.
ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc., is a development stage biotechnology company whose mission is to transform lives through the discovery and development of novel therapeutics. Regado applies its expertise to the development of therapies using actively controlled aptamer technology, which is designed to give physicians the ability to control the therapeutic effect in real time. More information can be found at www.regadobio.com.
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to financial projections and estimates and their underlying assumptions, future performance, the timing and amount of termination costs incurred in connection with our workforce reduction plan, the timing and amount of any decrease in annualized cash expenditures as a result of our workforce reduction plan, the timing for completion of the final closure of the REGULATE-PCI trial and outcome of the analysis of the unblinded database and the results of our ongoing efforts to identify and evaluate strategic business alternatives. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors.
| 106 Allen Road | Basking Ridge, NJ 07920 | www.regadobio.com |
Factors that could cause future results to materially differ from those projected in forward-looking statements include the timing and costs associated with our workforce reduction plan, the actual timing and costs associated with the final closure of the REGULATE-PCI trial, the timing and outcome of our unblinded database analysis and the outcome of our due diligence activities associated with exploring business strategic alternatives, as well as the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2014, and in the Company’s other periodic filings with the SEC. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company has no obligation, and expressly disclaims any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Don Elsey, CFO
Regado Biosciences, Inc.
908-580-2113
delsey@regadobio.com
Media Contacts:
David Schull or Lena Evans
Russo Partners
212-845-4271
212-845-4262
david.schull@russopartnersllc.com
lena.evans@russopartnersllc.com
| 106 Allen Road | Basking Ridge, NJ 07920 | www.regadobio.com |
Regado Biosciences, Inc.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
| September 30, 2014 (Unaudited) |
December 31, 2013 |
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| Assets |
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| Current assets: |
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| Cash and cash equivalents |
$ | 60,680 | $ | 30,688 | ||||
| Restricted cash |
1,082 | 82 | ||||||
| Prepaid expenses |
1,247 | 2,147 | ||||||
| Other assets |
5,517 | 6,211 | ||||||
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| Total current assets |
68,526 | 39,128 | ||||||
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| Property and equipment, net |
316 | 108 | ||||||
| Intangible assets, net |
1,350 | 1,823 | ||||||
| Other non-current assets |
— | 4,694 | ||||||
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| Total assets |
$ | 70,192 | $ | 45,753 | ||||
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| Liabilities and Stockholders’ Equity |
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| Current liabilities: |
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| Accounts payable |
$ | 4,105 | $ | 1,557 | ||||
| Accrued expenses |
8,259 | 5,524 | ||||||
| Warrant liability |
1 | 19 | ||||||
| Current portion of long-term debt |
4,089 | 2,000 | ||||||
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| Total current liabilities |
16,454 | 9,100 | ||||||
| Long-term debt |
— | 2,452 | ||||||
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| Total liabilities |
16,454 | 11,552 | ||||||
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| Commitments and contingencies |
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| Stockholders’ equity: |
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| Series F convertible preferred stock; stated value of $1,000, 1,000,000 shares authorized, 10,000 and 0 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively |
24,832 | — | ||||||
| Common stock, $0.001 par value; 500,000,000 shares authorized; 33,609,212 and 21,310,614 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively |
34 | 21 | ||||||
| Additional paid-in-capital |
232,190 | 179,159 | ||||||
| Accumulated Deficit |
(203,318 | ) | (144,979 | ) | ||||
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| Total stockholders’ equity |
53,738 | 34,201 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 70,192 | $ | 45,753 | ||||
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| 106 Allen Road | Basking Ridge, NJ 07920 | www.regadobio.com |
Regado Biosciences, Inc.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share data)
| For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
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| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Total revenue |
$ | — | $ | — | $ | — | $ | — | ||||||||
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| Operating expenses: |
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| Research and development |
(17,709 | ) | (9,597 | ) | (49,330 | ) | (15,594 | ) | ||||||||
| General and administrative |
(3,249 | ) | (1,614 | ) | (8,635 | ) | (4,240 | ) | ||||||||
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| Total operating expenses |
(20,958 | ) | (11,211 | ) | (57,965 | ) | (19,834 | ) | ||||||||
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| Loss from operations |
(20,958 | ) | (11,211 | ) | (57,965 | ) | (19,834 | ) | ||||||||
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| Other (expense) income: |
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| Interest income |
34 | 2 | 84 | 71 | ||||||||||||
| Interest expense |
(136 | ) | (146 | ) | (458 | ) | (545 | ) | ||||||||
| Other income (expense) |
— | (60 | ) | — | — | |||||||||||
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| Total other expense |
(102 | ) | (204 | ) | (374 | ) | (474 | ) | ||||||||
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| Net loss |
$ | (21,060 | ) | $ | (11,415 | ) | $ | (58,339 | ) | $ | (20,308 | ) | ||||
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| Deemed dividend related to beneficial conversion feature of Series F convertible preferred stock |
— | — | (14,840 | ) | — | |||||||||||
| Net loss attributable to stockholders |
(21,060 | ) | (11,415 | ) | (73,179 | ) | (20,308 | ) | ||||||||
| Net loss attributable to preferred stockholders |
1,183 | — | 3,329 | — | ||||||||||||
| Net loss attributable to common stockholders- basic and diluted |
$ | (19,877 | ) | $ | (11,415 | ) | $ | (69,850 | ) | $ | (20,308 | ) | ||||
| Comprehensive loss applicable to all stockholders |
(21,060 | ) | (11,415 | ) | (73,179 | ) | (20,308 | ) | ||||||||
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| Loss per share - basic and diluted |
$ | (0.59 | ) | $ | (1.43 | ) | $ | (2.35 | ) | $ | (7.18 | ) | ||||
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| Weighted-average common shares - basic and diluted |
33,609,212 | 8,005,142 | 29,664,548 | 2,828,757 | ||||||||||||
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| 106 Allen Road | Basking Ridge, NJ 07920 | www.regadobio.com |
Regado Biosciences, Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
| For the Nine Months Ended September 30, |
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| 2014 | 2013 | |||||||
| Cash flows used in operating activities: |
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| Net loss |
$ | (58,339 | ) | $ | (20,308 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: |
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| Depreciation |
86 | 41 | ||||||
| Amortization of patents and licenses |
114 | 75 | ||||||
| Impairment of patents |
748 | 10 | ||||||
| Impairment of clinical trial supplies |
8,190 | — | ||||||
| Impairment of prepaid expenses |
465 | — | ||||||
| Accrued final bank fee |
65 | 33 | ||||||
| Amortization of debt discount |
72 | 37 | ||||||
| Amortization of debt issuance costs |
8 | 100 | ||||||
| Change in fair value of warrant liability |
(18 | ) | (56 | ) | ||||
| Stock-based compensation |
1,641 | 346 | ||||||
| Loss on disposal of property and equipment |
15 | — | ||||||
| Other |
— | 64 | ||||||
| Changes in operating assets and liabilities: |
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| Prepaid expenses |
435 | (4,832 | ) | |||||
| Other assets |
(7,496 | ) | (244 | ) | ||||
| Other non-current assets |
4,686 | (1,855 | ) | |||||
| Accounts payable |
2,548 | 221 | ||||||
| Accrued expenses |
2,735 | 4,242 | ||||||
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| Net cash used in operating activities |
(44,045 | ) | (22,126 | ) | ||||
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| Cash flows used in investing activities: |
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| Change in restricted cash |
(1,000 | ) | — | |||||
| Purchase of property and equipment |
(309 | ) | (77 | ) | ||||
| Patent and license acquisition costs |
(389 | ) | (415 | ) | ||||
| Proceeds received from sale of patents |
— | 100 | ||||||
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| Net cash used in investing activities |
(1,698 | ) | (392 | ) | ||||
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| Cash flows from financing activities: |
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| Proceeds from borrowings on bank loan |
— | 4,500 | ||||||
| Repayment of borrowings on bank loan |
(500 | ) | (4,500 | ) | ||||
| Payment of bank origination fee |
— | (85 | ) | |||||
| Payment of debt issuance costs |
— | (57 | ) | |||||
| Proceeds from issuance of common stock, net of underwriting discounts and fees |
76,723 | 43,418 | ||||||
| Payment of offering costs |
(541 | ) | (2,231 | ) | ||||
| Proceeds from sale of preferred stock, net of issuance costs |
— | 10,163 | ||||||
| Proceeds from issuance of common stock from exercise of options and warrants |
53 | — | ||||||
| Proceeds from exercise of warrants |
— | 2 | ||||||
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| Net cash provided by financing activities |
75,735 | 51,210 | ||||||
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| Net increase in cash and cash equivalents |
$ | 29,992 | $ | 28,692 | ||||
| Cash and cash equivalents, beginning of period |
30,688 | 14,764 | ||||||
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| Cash and cash equivalents, end of period |
$ | 60,680 | $ | 43,456 | ||||
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| Supplemental disclosures of cash flow information: |
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| Cash paid for interest |
$ | 248 | $ | 465 | ||||
| Supplemental disclosure of non-cash investing and financing activities: |
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| Exchange of common stock for convertible preferred stock, net of issuance costs |
$ | 24,832 | $ | — | ||||
| Fair value of Series F Preferred Stock beneficial conversion feature |
$ | 14,840 | $ | — | ||||
| Accretion of deemed dividend on Series F Convertible Preferred Stock |
$ | (14,840 | ) | $ | — | |||
| Stock issued for cash held in escrow |
$ | — | $ | 5,155 | ||||
| 106 Allen Road | Basking Ridge, NJ 07920 | www.regadobio.com |