TREVENA,INC. (NASDAQ:TRVN) Files An 8-K Results of Operations and Financial Condition
Item 2.02. Results of Operations and Financial Condition.
The information under this caption and contained in the press release attached hereto as Exhibit99.1 is furnished by Trevena,Inc. (the “Company”) in accordance with Securities Exchange Commission Release No.33-8216. This information shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act whether made before or after the date of this Current Report, except as shall be expressly set forth by specific reference in such a filing.
OnJanuary28, 2019, the Company issued a press release that included the Company’s preliminary estimate of cash, cash equivalents, and marketable securities as of December31, 2018 of approximately $61.5 million. In March2019, the Company expects to issue a press release with full financial results for the fourth quarter and full year ended December31, 2018 and file with the U.S. Securities and Exchange Commission its Annual Report on Form10-K for the fiscal year ended December31, 2018. Based on its current estimates, the Company believes that its cash, cash equivalents, and marketable securities as of December31, 2018 will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2020.
Cautionary Note on Forward Looking Statements
Any statements in Item 2.02 of this Current Report on Form8-K regarding future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations (including the sufficiency of its cash, cash equivalents, and marketable securities to fund operations to a future date), clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to the Company’s intellectual property; the status, timing, costs, results and interpretation of the Company’s clinical trials; the uncertainties inherent in conducting clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical trials results will be indicative of the results of future trials; expectations for regulatory approvals; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and whether cash, cash equivalents, and marketable securities as of December31, 2018 will be sufficient to fund operating expenses and capital expenditure requirements into the second quarter of 2020; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form10-K and Quarterly Reports on Form10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this Current Report on Form8-K represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.
Item 2.02. Other Events
On January28, 2019, the Company issued a press release announcing the receipt of the official Type A meeting minutes from the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received for the oliceridine New Drug Application (NDA). A copy of the press release is furnished hereto as Exhibit99.1 and incorporated herein by reference
Item 2.02. Financial Statements and Exhibits.
(d) Exhibits
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Number |
Description |
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99.1 |
Press Release dated January28, 2019 |
TREVENA INC Exhibit
EX-99.1 2 a19-3483_1ex99d1.htm EX-99.1 Exhibit 99.1 Trevena Announces Receipt of Type A Meeting Minutes and Provides Regulatory Update for Oliceridine — Company announces initial path forward on oliceridine NDA — — Company to host conference call on Monday,…
To view the full exhibit click here
About TREVENA,INC. (NASDAQ:TRVN)
Trevena Inc. is a clinical-stage biopharmaceutical company. The Company discovers, develops and intends to commercialize therapeutics that use an approach to target G protein coupled receptors (GPCRs). Using its product platform, the Company has identified and advanced three differentiated product candidates: Oliceridine (TRV130), TRV027 and TRV250. Its TRV130 is a Mu-receptor G protein Pathway Selective (Mu-GPS) modulator that activates G protein. Its TRV250 is a small molecule G protein biased ligand of the d-opioid receptor in preclinical development. Its TRV734 is a small molecule Mu-GPS that it has discovered and has developed through Phase I as a first-line, orally administered compound for the treatment of moderate to severe acute and chronic pain. Its TRV027 is a peptide b-arrestin biased ligand that targets the angiotensin II type 1 receptor (AT1R). In addition to these three product candidates, the Company has identified and has completed the Phase I program for TRV734.
