TREVENA, INC. (NASDAQ:TRVN) Files An 8-K Results of Operations and Financial Condition
Item 2.02.
On March 5, 2020, Trevena, Inc. (the “Company”) issued a press release announcing an updated and extended cash runway, with a preliminarily estimate of cash, cash equivalents, and marketable securities of approximately $35.8 million as of December 31, 2019, which the Company believes will be sufficient to fund the Company’s operating expenses, debt service, and capital expenditure requirements into the first quarter of 2021.
The information above related to the Company\’s expected operating results for the year ended and as of December 31, 2019, including revenue and cash, cash equivalents and marketable securities, is preliminary, has not been audited and is subject to change upon completion of the audit of the Company\’s financial statements as of and for the year ended December 31, 2019. A copy of the press release is furnished hereto as Exhibit 99.1.
The information under this caption and contained in the press release attached hereto as Exhibit 99.1 is furnished by the Company in accordance with Securities Exchange Commission Release No. 33-8216. This information shall not be deemed “filed” for purposes of Section 18 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 (the “Securities Act”), or the Exchange Act whether made before or after the date of this Current Report on Form 8-K, except as shall be expressly set forth by specific reference in such a filing.
In connection with its press release dated March 5, 2020, the Company announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmitted New Drug Application (NDA) for IV oliceridine, the Company’s lead investigational asset for the management of moderate-to-severe acute pain.
In the acknowledgement letter, FDA stated that the Company’s filing is a complete, Class 2 response to the FDA’s action letter dated November 2, 2018. A Prescription Drug User Fee Act (PDUFA) goal date has been set for August 7, 2020. A copy of the press release is furnished hereto as Exhibit 99.1.
The information under this caption and contained in the press release attached hereto as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or incorporated by reference in any filing under the Securities Act or the Exchange Act whether made before or after the date of this Current Report on Form 8-K, except as shall be expressly set forth by specific reference in such a filing.
| 99.1 | Press Release dated March 5, 2020 |
TREVENA INC Exhibit
EX-99.1 2 tm2011771d1_ex99-1.htm EXHIBIT 99.1 EXHIBIT 99.1 Trevena Announces FDA Has Set PDUFA Date of August 7,…
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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.
