LEXINGTON, Mass., Nov. 4, 2014 (GLOBE NEWSWIRE) -- T2 Biosystems (Nasdaq:TTOO) today reported operating highlights and financial results for the third quarter ended September 30, 2014. Highlights of the quarter included:
- In September, the Company received authorization from the U.S. Food and Drug Administration (FDA) to market its first two products, the T2Candida® Panel and the T2Dx® Instrument for the detection of Candida species in whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections.
- In September, the Company’s T2MR® technology, an innovative and proprietary magnetic resonance-based diagnostic platform, was highlighted at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver. T2 Biosystems’ presence at ICAAC included a symposium focusing on T2MR’s rapid and sensitive identification of sepsis pathogens and its flagship T2Candida Panel.
- In August, the Company announced the close of its initial public offering (IPO) of 5,980,000 shares of common stock, including the underwriters overallotment, at a price of $11.00 per share, raising approximately $58 million net of offering costs.
- In July, the Company also obtained a European CE Mark and ISO 13485 certification for its T2Candida Panel and T2Dx Instrument.
President and CEO John McDonough said, “The activity level and pace of progress as an organization were extremely high in the third quarter. By executing a successful public financing and securing market authorization from the FDA for both a technology platform and an important initial diagnostic test panel, we put ourselves in a position to execute on our business plan. I am grateful to the entire organization, our partners and our investors for their commitment to what we believe is a critical change in how sepsis is managed.”
Financial Results
To date, the Company has generated revenue primarily from research and development agreements and government grants and has not generated any revenue from the sale of products. The Company did not record revenues for this year’s third quarter and first nine months. In last year’s third quarter and first nine months, T2 Biosystems recorded $91,000 and $0.2 million of research and grant revenue, respectively, which primarily consisted of revenue related to feasibility studies and co-development efforts with third parties.
Total operating expenses for the third quarter and first nine months of 2014 were $7.8 million and $21.8 million, respectively, compared to $4.6 million and $14.3 million for the 2013 periods. The increases in operating expenses were mainly associated with the direcT2 pivotal clinical trial and other regulatory support and activity, research and development activities for additional applications of T2MR, expansion of marketing programs, build-out of the US commercial infrastructure, and increases in share-based compensation charges and incremental expenses related to being a public company.
The net loss applicable to common shareholders for the 2014 third quarter was $8.8 million (after adjustments for accretion of redeemable convertible preferred stock), or $0.71 loss per share, compared to $6.6 million, or $4.69 loss per share for the 2013 third quarter. The increased loss was principally due to increased operating expenses noted above. For the first nine months of 2014, the net loss applicable to common shareholders was $26.9 million, or $5.25 loss per share, compared to $19.2 million, or $13.82 loss per share for the first nine months of 2013. Loss per share calculations for each of the periods reported were impacted by the overall increase in common shares outstanding resulting from the August 7, 2014 IPO.
The Company’s balance sheet as of September 30, 2014, showed total cash and cash equivalents of $75.6 million, including proceeds from the IPO in August.
Conference Call
T2 Biosystems’ management will discuss the Company’s financial results for the third quarter ended September 30, 2014, and provide a general business update during a conference call beginning at 4:30 p.m. Eastern Standard Time today, Tuesday, November 4, 2014. To join the call, participants may dial 1-877-407-4018 (U.S.) or 1-201-689-8471 (International). To listen to the live call via T2 Biosystems’ website, go to www.t2biosystems.com, in the Events & Presentations section. A webcast replay of the call will be available for 30 days following the conclusion of the call in the Events & Presentations section of the website.
About T2 Biosystems
T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, eliminating the time-consuming sample prep required in current methods. For more information, please visit www.t2biosystems.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the performance of the Company’s diagnostic products and the ability to work with the medical community to bring such products to hospitals, physicians and patients. These and other important factors discussed under the caption “Risk Factors” in the Company’s final prospectus filed with the Securities and Exchange Commission, pursuant to Rule 424(b) of the Securities Act of 1933, as amended, on August 7, 2014, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
– Tables to Follow –
| T2 Biosystems, Inc. | ||||
| Condensed Statements of Operations and Comprehensive Loss | ||||
| (In thousands, except share and per share data) | ||||
| (Unaudited) | ||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
| 2014 | 2013 | 2014 | 2013 | |
| Research and grant revenue | $ -- | $ 91 | $ -- | $ 211 |
| Operating expenses: | ||||
| Research and development expenses | 4,803 | 3,358 | 14,572 | 10,646 |
| Selling, general and administrative expenses | 2,984 | 1,275 | 7,271 | 3,618 |
| Total operating expenses | 7,787 | 4,633 | 21,843 | 14,264 |
| Loss from operations | (7,787) | (4,542) | (21,843) | (14,053) |
| Interest expense, net | (304) | (100) | (471) | (310) |
| Other income (expense), net | -- | -- | (1) | 125 |
| Net loss | $ (8,091) | $ (4,642) | $ (22,315) | $ (14,238) |
| Comprehensive loss | $ (8,091) | $ (4,642) | $ (22,315) | $ (14,238) |
| Reconciliation of net loss to net loss applicable to common stockholders: | ||||
| Net loss | $ (8,091) | $ (4,642) | $ (22,315) | $ (14,238) |
| Accretion of redeemable convertible preferred stock to redemption value | (758) | (1,911) | (4,570) | (4,998) |
| Net loss applicable to common stockholders | $ (8,849) | $ (6,553) | $ (26,885) | $ (19,236) |
| Net loss per share applicable to common stockholders - basic and diluted | $ (0.71) | $ (4.69) | $ (5.25) | $ (13.82) |
| Weighted-average number of common shares used in computing net loss per share applicable to common stockholders - basic and diluted | 12,379,337 | 1,398,425 | 5,120,977 | 1,392,110 |
| T2 Biosystems, Inc. | ||
| Condensed Balance Sheets | ||
| (In thousands, except share and per share data) | ||
| (Unaudited) | ||
| September 30, | December 31, | |
| 2014 | 2013 | |
| Assets | ||
| Current Assets: | ||
| Cash and cash equivalents | $75,589 | $30,198 |
| Prepaid expenses and other current assets | 1,087 | 195 |
| Total current assets | 76,676 | 30,393 |
| Property and equipment, net | 1,698 | 1,118 |
| Restricted cash | 340 | 340 |
| Other assets | 153 | 34 |
| Total assets | $78,867 | $31,885 |
| Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | ||
| Current liabilities: | ||
| Accounts payable | $725 | $943 |
| Accrued expenses | 5,580 | 1,319 |
| Current portion of notes payable | 290 | 1,759 |
| Current portion of deferred rent | 67 | 25 |
| Total current liabilities | 6,662 | 4,046 |
| Notes payable, net of current portion | 10,733 | 3,299 |
| Deferred rent, net of current portion | 18 | 45 |
| Warrants to purchase redeemable securities | -- | 1,225 |
| Other liabilities | 24 | -- |
| Commitments and contingencies | ||
| Redeemable convertible preferred stock | -- | 112,813 |
| Stockholders’ equity (deficit): | ||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued | -- | -- |
| Common stock, $0.001 par value; 200,000,000 and 28,254,907 shares authorized at September 30, 2014 and December 31, 2013, respectively; 20,040,604 and 1,411,986 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively | 20 | 1 |
| Additional paid-in capital | 155,929 | -- |
| Accumulated deficit | (94,519) | (89,544) |
| Total stockholders’ equity (deficit) | 61,430 | (89,543) |
| Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | $78,867 | $31,885 |
CONTACT: Media Contact: Dan Budwick, Pure Communications dan@purecommunicationsinc.com 973-271-6085 Investor Contact: Matt Clawson, Pure Communications matt@purecommunicationsinc.com 949-370-8500
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