Item 8.01 Other Events.
On March 26, 2020, Trevena, Inc. (the “Company”)
announced that due to the global COVID-19 pandemic, enrollment has been paused in the proof-of-concept clinical trials for TRV250
(treatment of acute migraine) and TRV734 (opioid use disorder). The Company is withdrawing its previous guidance with
respect to timing of top line data and will issue further information regarding these clinical trials as it becomes available.
The Company also announced the U.S. Food and Drug Administration’s (the “FDA”) review of the resubmission of
its NDA for oliceridine is ongoing and that the Company expects the FDA’s Prescription Drug User Fee Act goal date for the
completion of the FDA’s review of the NDA to remain August 7, 2020.
The Company is also supplementing and updating the risk factors
in its prior filings with the Securities and Exchange Commission (the “SEC”), including those discussed under the heading
“Item 1A. Risk Factors,” in the Company’s most recent Annual Report on Form 10-K for the year ended
December 31, 2019, filed with the SEC on March 12, 2020:
Our business could be adversely affected by the
effects of health epidemics and pandemics, including the recent COVID-19 outbreak, in regions where we or third parties on
which we rely have significant concentrations of clinical trial sites or other business operations. The COVID-19 pandemic
could materially affect our operations, including at our headquarters in Pennsylvania and at our clinical trial sites, as
well as the business or operations of our CROs or other third parties with whom we conduct business.
Our business could be adversely affected by health epidemics
in regions where we have concentrations of clinical trial sites or other business operations and could cause significant disruption
in the operations of CROs upon whom we rely. For example, in December 2019, a novel strain of coronavirus,
SARS-CoV-2, causing a disease referred to as COVID-19, was reported to have surfaced in Wuhan, China. Since then, COVID-19 has
spread to multiple countries, including the United States and several European countries. In March 2020, the World Health Organization
declared the COVID-19 outbreak a pandemic. Further, the President of the United States declared the COVID-19 pandemic a national
emergency. The Governor of Pennsylvania declared a state of emergency related to the spread of COVID-19, and issued orders directing
all individuals in seven counties, including where our headquarters is located, to “stay at home” except to perform
certain essential activities. The orders took effect on March 23, 2020 and will continue until at least April 6, 2020. We have
implemented work-from-home policies for all employees. The effects of the Pennsylvania orders and our work-from-home policies
may negatively impact productivity, disrupt our business and delay our clinical programs and timelines, the magnitude of which
will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business
in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business,
operating results and financial condition.
In addition, our clinical trials may be affected by the COVID-19
pandemic. Clinical site initiation and patient enrollment may be delayed due to prioritization of hospital resources toward the
COVID-19 pandemic. For instance, enrollment has been paused in our proof-of-concept clinical trials for TRV250 (treatment of acute
migraine) and TRV734 (opioid use disorder). Also, some patients may not be able to comply with clinical trial protocols
if quarantines impede patient movement or interrupt healthcare services. Similarly, our ability to recruit and retain patients
and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 and adversely
impact our clinical trial operations.
The spread of COVID-19, which has caused a broad impact globally,
may materially affect us economically. While the potential economic impact brought by, and the duration of, COVID-19 may be difficult
to assess or predict, a widespread pandemic could result in significant disruption of global financial markets, reducing our ability
to access capital, which could in the future negatively affect our liquidity. In addition, a recession or market correction resulting
from the spread of COVID-19 could materially affect our business and the value of our common stock.
Forward-Looking Statements
Any statements in this Current Report on Form 8-K about future
expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations,
clinical development and trials of its 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 global COVID-19 pandemic; the status, timing, costs, results and interpretation of the Company’s clinical trials or any
future trials of any of the Company’s product candidates; the uncertainties inherent in conducting clinical trials; expectations
for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with FDA and
the timing of FDA’s decision on the oliceridine NDA; available funding; and other factors discussed in the Risk Factors set
forth in the Company’s Annual Report on Form 10-K filed with the SEC and in other filings the Company makes with the SEC
from time to time. In addition, the forward-looking statements included in this report 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.