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 third quarter ended
September 30, 2024 and provided an overview of its recent
operational updates.
Third Quarter 2024 and Recent Corporate
Updates
- $2 million Non-Dilutive
Financing Tranche. In July 2024, the Company announced
receipt of a non-dilutive, $2 million tranche in connection with an
amendment (the “Amendment”) to its existing ex-US royalty financing
with R-Bridge Healthcare Fund (“R-Bridge”). The Company is further
eligible to receive up to an additional $8 million based on future
milestones. As part of the Amendment, (i) certain OLINVYK Chinese
IP that had been previously pledged to R-Bridge under the Royalty
Financing was transferred to R-Bridge, (ii) warrants previously
issued to R-Bridge as part of the Royalty Financing were amended to
reduce the exercise price to a 15% premium to the then-current
stock price and to extend the exercise period to five years from
the effective date of the Amendment, (iii) the existing cap on the
US royalty payable to R-Bridge was increased from $10 million to
$12 million (with no minimum or fixed payments), and (iv) R-Bridge
agreed to forgive $10.0 million of the amount that was outstanding
to them prior to the Amendment. This $10.0 million forgiveness was
determined to be a troubled debt restructuring and therefore no
gain will be recognized by the Company for accounting
purposes.
- Reverse Stock
Split. In August 2024 the Company effected a 1-for-25
reverse stock of the Company’s common stock (the “Reverse Stock
Split”). As a result of the Reverse Stock Split, each 25 shares of
the Company’s issued and outstanding common stock were
automatically combined into one validly issued, fully paid and
non-assessable share of common stock. In addition, proportional
adjustments were made to the number of shares of the Company’s
common stock issuable under the Company’s equity incentive plans
and all outstanding securities and other rights convertible or
exercisable into shares of the Company’s common stock, including
all stock options and warrants outstanding immediately prior to the
effectiveness of the Reverse Stock Split. The Reverse Stock Split
did not have any effect on the stated par value of the Company’s
common stock.
- Nasdaq Delisting and
Subsequent Initiation of Trading on OTC Pink
Sheets. On October 4, 2024, the Company
announced that it had received notice that the Nasdaq Hearings
Panel (the “Panel”) had determined to delist the Company’s common
stock from The Nasdaq Stock Market LLC (“Nasdaq”) due to the
Company’s failure to comply with the minimum stockholder’s equity
requirement under Nasdaq Listing Rule 5550(b)(1) (the “Equity
Standard Rule”). As previously disclosed, the Panel had provided
the Company until October 2, 2024, to regain compliance with the
Equity Standard Rule. Trading in the Company’s common stock was
suspended on Nasdaq effective with the open of business on October
8, 2024, and the Company’s common stock began trading on the Pink
Open Market operated by the OTC Markets Group, Inc. (commonly
referred to as the “pink sheets”) on October 8, 2024 under the
trading symbol “TRVN.”
- Additional Cost-Cutting Measures. On
October 5, 2024, in connection with certain cost-cutting
measures, the Board of Directors (“the Board”) approved the
termination of employment, without cause, of three senior
executives: Carrie Bourdow (President & CEO), Mark Demitrack
(SVP & CMO), and Barry Shin (EVP & COO/CFO). The
terminations did not involve any disagreement concerning the
Company’s operations, policies or practices, and the Board thanked
these executives for their service to the Company. Following the
effectiveness of these terminations, Ms. Bourdow continues to serve
as Chairman of the Board and Acting CEO; Mr. Demitrack continues to
serve as Acting CMO; Mr. Shin continues to serve as Acting COO/CFO;
and all entered into consulting agreements with the Company.
Following these cost-cutting measures, the Company has four
employees.
- Resignation of Certain Directors. On November
5, 2024, in connection with the ongoing cost-cutting measures, Mark
Corrigan, M.D.; Marvin H. Johnson, Jr.; Jake R. Nunn; and Anne M.
Phillips each informed the Company of his or her intent to resign
from the Board and the committees thereof, effective as of November
5, 2024. None of these resignations was related to any disagreement
with the Company over any of its operations, policies or practices.
Carrie Bourdow continues to serve as Chairman of the Board and
Scott Braunstein, M.D. and Barbara Yanni continue to serve as
directors of the Company.
- Continued Strategic Review. The Company
continues its review of strategic alternatives, including for
OLINVYK, TRV045 and its other pipeline assets. There can be no
assurance regarding the schedule for completion of the strategic
review process, that this strategic review process will result in
the Company pursuing any transaction or that any transaction, if
pursued, will be completed. Potential strategic alternatives that
may be explored or evaluated include, but are not limited to, a
sale, license, divestiture or discontinuation of US commercial
sales of OLINVYK; a sale, license or divestiture of our pipeline
assets; or a sale, merger or wind down of the Company.
Financial Results and Other Updates for Third Quarter
2024For the third quarter of 2024, the Company reported a
net loss attributable to common stockholders of $4.9 million, or
$5.79 per share, compared to $7.9 million, or $14.20 per share in
the third quarter of 2023. Cash and cash equivalents were $13.5
million as of September 30, 2024.
About Trevena
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 three differentiated
investigational drug candidates: TRV045 for diabetic neuropathic
pain and epilepsy, TRV250 for the acute treatment of migraine and
TRV734 for maintenance treatment of opioid use disorder.
For more information, please
visit www.Trevena.com
About TRV045
TRV045 is a novel, highly selective
sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being
developed as a potential treatment for acute and chronic
neuropathic pain secondary to diabetic peripheral neuropathy.
Through a collaboration with the National Institutes of Health,
Trevena is also exploring TRV045 as a potential treatment for
epilepsy.
S1P receptors are located throughout the body,
including the central nervous system, where they are believed to
play a role in modulating neurotransmission and membrane
excitability.
Trevena's discovery efforts have identified a family of
compounds that are highly selective for the S1P1 receptor. TRV045
reversed thermal hyperalgesia, a measure of neuropathic pain, in
nonclinical models of diabetic peripheral neuropathy and
chemotherapy-induced peripheral neuropathy. TRV045 was not
associated with lymphopenia and produced no changes in blood
pressure, heart rate, or respiratory function at or above
pharmacologically active doses in nonclinical studies. TRV045 is an
investigational product and is not yet approved by the FDA.
Subjects in both studies referenced in this press release were
enrolled outside of the United States, and the studies were not
conducted under the Investigational New Drug Application for
TRV045.
About
OLINVYK® (oliceridine)
injection
OLINVYK is a new chemical entity approved by the
FDA in August 2020. OLINVYK contains oliceridine, an opioid, which
is 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.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS AND LIFE-THREATENING
RISKS FROM USE
OF OLINVYK
Addiction, Abuse, and Misuse
Because the use of OLINVYK exposes patients and other
users to the risks of opioid addiction, abuse, and misuse, which
can lead to overdose and death, assess each patient’s risk prior to
prescribing and reassess all patients regularly for the development
of these behaviors and conditions.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory
depression may occur with use of OLINVYK, especially during
initiation or following a dosage increase. To reduce the risk of
respiratory depression, proper dosing and titration of OLINVYK are
essential.
Risks From Concomitant Use With Benzodiazepines Or Other
CNS Depressants
Concomitant use of opioids with benzodiazepines or other
central nervous system (CNS) depressants, including alcohol, may
result in profound sedation, respiratory depression, coma, and
death. Reserve concomitant prescribing of OLINVYK and
benzodiazepines or other CNS depressants for use in patients for
whom alternative treatment options are inadequate.
Neonatal Opioid Withdrawal Syndrome
If opioid use is required for an extended period of time
in a pregnant woman, advise the patient of the risk of NOWS, which
may be life-threatening if not recognized and treated. Ensure that
management by neonatology experts will be available at
delivery.
INDICATIONS AND USAGE
OLINVYK is an opioid agonist indicated in adults for the
management of acute pain severe enough to require an intravenous
opioid analgesic and for whom alternative treatments are
inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with
opioids, which can occur at any dosage or duration, reserve OLINVYK
for use in patients for whom alternative treatment options [e.g.,
non-opioid analgesics or opioid combination products]:
- Have not been tolerated or are not
expected to be tolerated.
- Have not provided adequate analgesia
or are not expected to provide adequate analgesia.
The cumulative total daily dose should not exceed 27 mg.
CONTRAINDICATIONS
OLINVYK is contraindicated in patients with:
- Significant respiratory
depression
- Acute or severe bronchial asthma in
an unmonitored setting or in absence of resuscitative
equipment
- Known or suspected gastrointestinal
obstruction, including paralytic ileus
- Known hypersensitivity to
oliceridine (e.g. anaphylaxis)
WARNINGS AND PRECAUTIONS
- OLINVYK contains oliceridine, a Schedule II controlled
substance, that exposes users to the risks of addiction, abuse, and
misuse. Although the risk of addiction in any individual is
unknown, it can occur in patients appropriately prescribed OLINVYK.
Assess risk, counsel, and monitor all patients receiving
opioids.
- Serious, life-threatening respiratory depression has been
reported with the use of opioids, even when used as recommended,
especially in patients with chronic pulmonary disease, or in
elderly, cachectic and debilitated patients. The risk is greatest
during initiation of OLINVYK therapy, following a dose increase, or
when used with other drugs that depress respiration. Proper dosing
of OLINVYK is essential, especially when converting patients from
another opioid product to avoid overdose. Management of respiratory
depression may include close observation, supportive measures, and
use of opioid antagonists, depending on the patient’s clinical
status.
- Opioids can cause sleep-related
breathing disorders including central sleep apnea (CSA) and
sleep-related hypoxemia with risk increasing in a dose-dependent
fashion. In patients who present with CSA, consider decreasing the
dose of opioid using best practices for opioid taper.
- Profound sedation, respiratory
depression, coma, and death may result from the concomitant use of
OLINVYK with benzodiazepines and/or other CNS depressants (e.g.,
non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers,
muscle relaxants, general anesthetics, antipsychotics, other
opioids, or alcohol). Because of these risks, reserve concomitant
prescribing of these drugs for use in patients for whom alternative
treatment options are inadequate, prescribe the lowest effective
dose, and minimize the duration.
- Use of OLINVYK for an extended
period of time during pregnancy can result in withdrawal in the
neonate that may be life-threatening. Observe newborns for signs of
neonatal opioid withdrawal syndrome and manage accordingly. Advise
pregnant women using opioids for a prolonged period of the risk of
neonatal opioid withdrawal syndrome and ensure that appropriate
treatment will be available.
- OLINVYK was shown to have mild QTc
interval prolongation in thorough QT studies where patients were
dosed up to 27 mg. Total cumulative daily doses exceeding 27 mg per
day were not studied and may increase the risk for QTc interval
prolongation. Therefore, the cumulative total daily dose of OLINVYK
should not exceed 27 mg.
- Increased plasma concentrations of
OLINVYK may occur in patients with decreased Cytochrome P450 (CYP)
2D6 function or normal metabolizers taking moderate or strong
CYP2D6 inhibitors; also in patients taking a moderate or strong
CYP3A4 inhibitor, in patients with decreased CYP2D6 function who
are also receiving a moderate or strong CYP3A4 inhibitor, or with
discontinuation of a CYP3A4 inducer. These patients may require
less frequent dosing and should be closely monitored for
respiratory depression and sedation at frequent intervals.
Concomitant use of OLINVYK with CYP3A4 inducers or discontinuation
of a moderate or strong CYP3A4 inhibitor can lower the expected
concentration, which may decrease efficacy, and may require
supplemental doses.
- Opioid-Induced Hyperalgesia (OIH)
occurs when an opioid analgesic paradoxically causes an increase in
pain, or an increase in sensitivity to pain. This differs from
tolerance where increasing doses are required to maintain the
desired effect. Symptoms of OIH include, but may not be limited to,
increased levels of pain upon dose increase, decreased levels of
pain upon dose decrease, or pain from ordinarily non-painful
stimuli (allodynia). These symptoms may suggest OIH only if there
is no evidence of disease progression, opioid tolerance,
withdrawal, or addictive behavior. If OIH is suspected, carefully
consider appropriately decreasing the dose of the current opioid
analgesic or opioid rotation.
- Cases of adrenal insufficiency have
been reported with opioid use (usually greater than one month).
Presentation and symptoms may be nonspecific and include nausea,
vomiting, anorexia, fatigue, weakness, dizziness, and low blood
pressure. If confirmed, treat with physiologic replacement doses of
corticosteroids and wean patient from the opioid.
- OLINVYK may cause severe
hypotension, including orthostatic hypotension and syncope in
ambulatory patients. There is increased risk in patients whose
ability to maintain blood pressure has already been compromised by
a reduced blood volume or concurrent administration of certain CNS
depressant drugs (e.g., phenothiazines or general anesthetics).
Monitor these patients for signs of hypotension. In patients with
circulatory shock, avoid the use of OLINVYK as it may cause
vasodilation that can further reduce cardiac output and blood
pressure.
- Avoid the use of OLINVYK in
patients with impaired consciousness or coma. OLINVYK should be
used with caution in patients who may be susceptible to the
intracranial effects of CO2 retention, such as those with evidence
of increased intracranial pressure or brain tumors, as a reduction
in respiratory drive and the resultant CO2 retention can further
increase intracranial pressure. Monitor such patients for signs of
sedation and respiratory depression, particularly when initiating
therapy.
- As with all opioids, OLINVYK may
cause spasm of the sphincter of Oddi, and may cause increases in
serum amylase. Monitor patients with biliary tract disease,
including acute pancreatitis, for worsening symptoms.
- OLINVYK may increase the frequency
of seizures in patients with seizure disorders and may increase the
risk of seizures in vulnerable patients. Monitor patients with a
history of seizure disorders for worsened seizure control.
- Do not abruptly discontinue OLINVYK
in a patient physically dependent on opioids. Gradually taper the
dosage to avoid a withdrawal syndrome and return of pain. Avoid the
use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and
butorphanol) or partial agonist (e.g., buprenorphine) analgesics in
patients who are receiving OLINVYK, as they may reduce the
analgesic effect and/or precipitate withdrawal symptoms.
- OLINVYK may impair the mental or
physical abilities needed to perform potentially hazardous
activities such as driving a car or operating machinery.
- Although self-administration of
opioids by patient-controlled analgesia (PCA) may allow each
patient to individually titrate to an acceptable level of
analgesia, PCA administration has resulted in adverse outcomes and
episodes of respiratory depression. Health care providers and
family members monitoring patients receiving PCA analgesia should
be instructed in the need for appropriate monitoring for excessive
sedation, respiratory depression, or other adverse effects of
opioid medications.
ADVERSE REACTIONS
Adverse reactions are described in greater
detail in the Prescribing Information.
The most common (incidence ≥10%) adverse
reactions in Phase 3 controlled clinical trials were nausea,
vomiting, dizziness, headache, constipation, pruritus, and
hypoxia.
MEDICAL INFORMATION
For medical inquiries or to report an adverse
event, other safety-related information or product complaints for a
company product, please contact the Trevena Medical Information
Contact Center at 1-844-465-4686 or email MedInfo@Trevena.com.
You are encouraged to report suspected adverse
events of prescription drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
PLEASE see www.OLINVYK.com
for full prescribing information including BOXED warning
and important safety information
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 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: the expectations surrounding the continued
advancement of the Company’s product pipeline; the potential safety
and efficacy of the Company’s product candidates and their
regulatory and clinical development; the Company’s intention to
pursue strategic alternatives for OLINVYK and the ability of any
such strategic alternative to provide shareholder value; the
expected financial and operational impacts of the Company’s
decision to reduce commercial support for OLINVYK; 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 discussions with
FDA; available funding; uncertainties related to continued listing
on NASDAQ; uncertainties related to the Company’s intellectual
property; uncertainties related to other matters that could affect
the availability or commercial potential of the Company’s
therapeutic candidates and approved product; 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:
Company Contact:
Bob YoderSVP, Chief Business Officer & Head
of Commercial OperationsTrevena, Inc.(610) 354-8840
TREVENA,
INC. |
|
Condensed
Statements of Operations |
|
(Unaudited,
in thousands except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended Sept 30, |
|
Nine Months Ended Sept 30, |
|
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
Product
revenue |
|
$ |
(21 |
) |
|
$ |
1 |
|
|
$ |
13 |
|
|
$ |
28 |
|
|
License
revenue |
|
|
304 |
|
|
|
179 |
|
|
|
615 |
|
|
|
3,179 |
|
|
Total revenue |
|
|
283 |
|
|
|
180 |
|
|
|
628 |
|
|
|
3,207 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
114 |
|
|
|
175 |
|
|
|
305 |
|
|
|
389 |
|
|
Selling, general and administrative |
|
|
3,880 |
|
|
|
4,572 |
|
|
|
13,323 |
|
|
|
15,799 |
|
|
Research and development |
|
|
1,866 |
|
|
|
4,260 |
|
|
|
8,958 |
|
|
|
12,160 |
|
|
Total operating expenses |
|
|
5,860 |
|
|
|
9,007 |
|
|
|
22,586 |
|
|
|
28,348 |
|
|
Loss from
operations |
|
|
(5,577 |
) |
|
|
(8,827 |
) |
|
|
(21,958 |
) |
|
|
(25,141 |
) |
|
Other
income |
|
|
638 |
|
|
|
897 |
|
|
|
4,450 |
|
|
|
1,380 |
|
|
Net
loss |
|
$ |
(4,939 |
) |
|
$ |
(7,930 |
) |
|
$ |
(17,508 |
) |
|
$ |
(23,761 |
) |
|
|
|
|
|
|
|
|
|
|
|
Per share
information: |
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
($5.79 |
) |
|
($14.20 |
) |
|
($20.54 |
) |
|
($50.65 |
) |
|
Weighted average shares outstanding, basic and diluted |
|
852,801 |
|
|
|
558,564 |
|
|
|
852,253 |
|
|
|
469,149 |
|
|
|
|
|
|
|
|
|
|
|
|
TREVENA,
INC. |
Condensed
Balance Sheets |
(Unaudited,
in thousands) |
|
|
|
|
|
|
|
September
30, 2024 |
December 31,
2023 |
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
13,462 |
|
|
$ |
32,975 |
|
Restricted cash |
|
|
282 |
|
|
|
- |
|
Prepaid expenses and other current assets |
|
|
991 |
|
|
|
2,230 |
|
Total current assets |
|
|
14,735 |
|
|
|
35,205 |
|
Restricted
cash, net of current portion |
|
|
340 |
|
|
|
540 |
|
Property and
equipment, net |
|
|
923 |
|
|
|
1,195 |
|
Right-of-use
lease assets |
|
|
3,190 |
|
|
|
3,665 |
|
Total
assets |
|
$ |
19,188 |
|
|
$ |
40,605 |
|
|
|
|
|
|
Liabilities and stockholders’ (deficit)
equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable, net |
|
$ |
918 |
|
|
$ |
2,303 |
|
Accrued expenses and other current liabilities |
|
|
3,164 |
|
|
|
4,239 |
|
Current portion of loans payable, net |
|
|
902 |
|
|
|
- |
|
Lease liabilities |
|
|
1,102 |
|
|
|
1,012 |
|
Total current liabilities |
|
|
6,086 |
|
|
|
7,554 |
|
Loans
payable, net |
|
|
31,972 |
|
|
|
30,809 |
|
Leases, net
of current portion |
|
|
3,588 |
|
|
|
4,424 |
|
Warrant
liability |
|
|
851 |
|
|
|
5,475 |
|
Total
liabilities |
|
|
42,497 |
|
|
|
48,262 |
|
|
|
|
|
|
Common
stock |
|
|
1 |
|
|
|
1 |
|
Additional
paid-in capital |
|
|
582,259 |
|
|
|
580,403 |
|
Accumulated
deficit |
|
|
(605,569 |
) |
|
|
(588,061 |
) |
Total stockholders’ (deficit) equity |
|
|
(23,309 |
) |
|
|
(7,657 |
) |
Total liabilities and stockholders’ (deficit) equity |
|
$ |
19,188 |
|
|
$ |
40,605 |
|
|
|
|
|
|
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