Full Press Release Details
Reports Second Quarter 2021 Results
Company reaffirms YE goal of 100 formulary
OLINVYK respiratory physiology study currently
enrolling, topline data expected by YE 2021
NIH / Vanderbilt University Medical Center-led
trial evaluating TRV027 currently enrolling COVID-19 patients
Cleveland Clinic outcomes study investigating
potential benefit of OLINVYK on respiratory, GI, and cognitive function on track to enroll patients in Q3
TRV045 IND filing for diabetic neuropathic
pain on track for Q3
$91M cash at Q2 funds operations through YE
Company to host conference call today, August
12th, 2021, at 8:00 a.m. ET
CHESTERBROOK, PA, August 12, 2021 (GLOBE NEWSWIRE)
-- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines
for patients with central nervous system (CNS) disorders, today reported its financial results for the second quarter ended June 30, 2021
and provided an overview of its recent operational highlights.
"With only five months in the field, our
sales team has continued to make progress with hospital formularies on the OLINVYK launch, and we've begun to roll out our post-approval
clinical study plan to further differentiate its unique clinical profile," said Carrie Bourdow, President and CEO of Trevena. "Additionally,
we achieved meaningful milestones in our pipeline, with trials underway for TRV027 and TRV734 in collaboration with world-class research
Second Quarter 2021 and Recent Corporate Highlights:
OLINVYK (oliceridine) injection Milestones
Initiated respiratory physiology study in elderly / obese subjects. In July, the Company announced a new study evaluating the role
of age and weight in a comparative analysis of the effect of OLINVYK and morphine on respiratory function. The study is being led by a
world-renowned research group that specializes in the effects of opioid medications on human respiratory physiology. Patient enrollment
is ongoing and on track to support topline data by year-end 2021.
clinical development progress made by ex-U.S. partner. In July, the Company announced that Jiangsu Nhwa Pharmaceutical, the Company's
partner in China, had enrolled the first patient in their Phase 3 trial for OLINVYK. Nhwa is conducting and funding this trial to support
an NDA regulatory filing in China. The Company expects to receive approval and commercialization milestones, and a 10% royalty on net
Pipeline and Corporate Milestones
Financial Results for Second Quarter 2021
For the second quarter
of 2021, the Company reported a net loss attributable to common stockholders of $14.0 million, or $0.09 per share, compared to $6.2 million,
or $0.06 per share, for the second quarter of 2020. This increase is primarily related to increases in commercialization activities for
Cash and cash equivalents
were $91.0 million as of June 30, 2021, which the Company believes will be sufficient to fund the Company's operating expenses and
capital expenditure requirements through the fourth quarter of 2022.
The Company will host
a conference call and webcast with the investment community on August 12, 2021, at 8:00 a.m. Eastern Time featuring remarks by Carrie
Bourdow, President and Chief Executive Officer, Bob Yoder, Senior Vice President and Chief Commercial Officer, Mark Demitrack, M.D., Senior
Vice President and Chief Medical Officer, and Barry Shin, Senior Vice President and Chief Financial Officer.
| Title: | Trevena Second Quarter 2021 Financial Results Conference Call and Webcast |
| Date: | Thursday, August 12, 2021 |
| Time: | 8:00 a.m. ET |
| Conference Call Details: | Toll-Free: (855) 465-0180 International: (484) 756-4313 Conference ID: 6799504 |
| Webcast: | https://www.trevena.com/investors/events-presentations/ir-calendar |
About OLINVYK (oliceridine) injection
OLINVYK is a new chemical entity approved by
the FDA in August 2020. OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other
opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for
whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use
vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered.
The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing
information at www.OLINVYK.com.
Trevena, Inc. is a biopharmaceutical company focused
on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product
in the United States, OLINVYK (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require
an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company's novel pipeline is based on Nobel
Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734
for maintenance treatment of opioid use disorder, TRV045 for diabetic neuropathic pain and epilepsy, and TRV027 for acute respiratory
distress syndrome and abnormal blood clotting in COVID-19 patients.
For more information, please visit www.Trevena.com.
Forward-Looking Statements
Any statements in this press release about future
expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical
development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug
products and other statements containing the words "anticipate," "believe," "estimate," "expect,"
"intend," "may," "might," "plan," "objective," "predict," "project,"
"suggest," "target," "potential," "will," "would," "could," "should,"
"continue," "ongoing," or the negative of these terms or 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: the commercialization of any approved drug product,
the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's
investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions
and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all
of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's
intellectual property; uncertainties related to the ongoing COVID-19 pandemic, 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 Form 10-K and Quarterly Reports on Form 10-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 press release 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.
For more information, please contact:
LifeSci Advisors, LLC
Associate Vice President
(Unaudited, in thousands except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Product revenue | $ | 178 | $ | - | $ | 387 | $ | - | ||||||||
| Total revenue | 178 | - | 387 | - | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold | 258 | - | 421 | - | ||||||||||||
| Selling, general and administrative | 10,545 | 3,300 | 17,913 | 6,932 | ||||||||||||
| Research and development | 3,449 | 2,958 | 6,085 | 5,149 | ||||||||||||
| Total operating expenses | 14,252 | 6,258 | 24,419 | 12,081 | ||||||||||||
| Loss from operations | (14,074 | ) | (6,258 | ) | (24,032 | ) | (12,081 | ) | ||||||||
| Other income | 52 | 36 | 168 | 134 | ||||||||||||
| Net loss | $ | (14,022 | ) | $ | (6,222 | ) | $ | (23,864 | ) | $ | (11,947 | ) | ||||
| Per share information: | ||||||||||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.09 | ) | $ | (0.06 | ) | $ | (0.15 | ) | $ | (0.12 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 163,370,485 | 111,297,428 | 161,936,680 | 103,814,876 |
| TREVENA, INC. | ||||||||
| Condensed Balance Sheets | ||||||||
| (Unaudited, in thousands) | ||||||||
| June 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 90,952 | $ | 109,403 | ||||
| Accounts receivable, net | 137 | 71 | ||||||
| Inventories | 1,045 | - | ||||||
| Insurance recovery | 9,000 | 9,000 | ||||||
| Prepaid expenses and other current assets | 1,998 | 570 | ||||||
| Total current assets | 103,132 | 119,044 | ||||||
| Restricted cash | 1,310 | 1,310 | ||||||
| Property and equipment, net | 2,039 | 2,253 | ||||||
| Right-of-use lease assets | 4,921 | 5,119 | ||||||
| Other assets | 799 | 13 | ||||||
| Total assets | $ | 112,201 | $ | 127,739 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable, net | $ | 2,374 | $ | 1,693 | ||||
| Accrued expenses and other current liabilities | 2,852 | 5,168 | ||||||
| Estimated settlement liability | 9,000 | 9,000 | ||||||
| Current portion of lease liabilities | 748 | 703 | ||||||
| Total current liabilities | 14,974 | 16,564 | ||||||
| Leases, net of current portion | 6,718 | 7,101 | ||||||
| Warrant liability | 1 | 6 | ||||||
| Total liabilities | 21,693 | 23,671 | ||||||
| Common stock | 165 | 160 | ||||||
| Additional paid-in capital | 556,721 | 546,422 | ||||||
| Accumulated deficit | (466,378 | ) | (442,514 | ) | ||||
| Total stockholders' equity | 90,508 | 104,068 | ||||||
| Total liabilities and stockholders' equity | $ | 112,201 | $ | 127,739 |