Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a
rare disease therapeutics company, today announced the completion
of its acquisition of Acer Therapeutics Inc. (Acer) which marks a
significant step forward in executing Zevra’s strategy to become a
leader in developing and commercializing treatments for rare
diseases and furthers the Company’s commitment to supporting
patient communities with limited or no existing therapeutic
options. As previously announced on August 31, 2023, the
capital-efficient transaction included approximately 2.96 million
shares of Zevra stock and contingent value rights (CVRs) issued in
exchange for all outstanding shares of Acer. The CVRs represent the
right to receive up to $76 million payable upon the achievement of
certain regulatory and net sales milestones, net of the amount
payable, if any, to SWK Funding LLC, a former warrantholder of
Acer. In addition, immediately prior to the signing and
announcement of the merger agreement, Zevra purchased Acer’s senior
secured debt for a combination of cash, Zevra stock and notes
valued at $28.5 million as a condition of entering into the merger
agreement with Acer.
“Today’s acquisition marks an exciting milestone
for Zevra as we advance our mission to deliver therapies to the
rare disease community,” said Neil F. McFarlane, President and
Chief Executive Officer of Zevra. “With our combined resources,
expanded portfolio, and expert capabilities, we have the
opportunity to make a tremendous impact on the lives of people with
serious rare diseases. We are excited about the opportunities ahead
for patients and remain focused on executing our strategic
priorities to create long-term shareholder value.”
The acquisition of Acer brings multiple rare
disease assets and increases Zevra’s revenue potential with the
addition of OLPRUVA®, which is indicated for the treatment of
certain urea cycle disorders (UCDs), expands Zevra’s clinical
portfolio with EDSIVO™, currently in Phase 3 for vascular
Ehlers-Danlos syndrome (vEDS). The acquisition brings complementary
assets and bolsters Zevra’s commercial and development capabilities
with the addition of key Acer personnel and existing commercial
systems.
“The integration of Acer’s programs,
capabilities and accomplished team complements and enhances Zevra’s
portfolio, and advances our mission to bring life-changing
therapies to patients with rare diseases,” said Joshua Schafer,
Chief Commercial Officer and Executive Vice President of Business
Development of Zevra. “Acer’s programs and capabilities are an
excellent fit for Zevra, particularly OLPRUVA for UCDs, which is a
serious rare genetic metabolic disorder. There is a high degree of
overlap between the diagnosing physicians and Centers of Excellence
where patients with UCDs and Niemann-Pick disease type C (NPC) are
treated. We believe this overlap will allow us to realize synergies
and scale to efficiently commercialize both programs.”
Subsequent to the closing of the Acer
transaction, Zevra announced that it has agreed to sell an
aggregate of 1,382,489 shares of its common stock and accompanying
warrants to purchase up to 1,382,489 shares of common stock at a
price of $4.34 per share to a healthcare focused investment fund
(the “Investor”) for gross proceeds of approximately $6.0 million
and an aggregate of 917,934 shares of its common stock to cancel a
warrant held by the Investor to purchase 2,920,306 shares of common
stock of Acer (the “Transaction”). The shares of common stock and
the warrants were offered and sold to the Investor in a registered
direct offering conducted without an underwriter or placement
agent. The Transaction is expected to close on or about November
22, 2023, subject to customary closing conditions.
The securities described above are being sold by
Zevra pursuant to a registration statement on Form S-3
(Registration No. 333-257661), which was filed with the Securities
Exchange Commission (the “SEC”) on July 2, 2021, and became
effective on July 12, 2021, and the prospectus contained therein,
as supplemented by a prospectus supplement to be filed with the
SEC. The securities will be sold only by means of a prospectus,
forming a part of the effective registration statement. Electronic
copies of the accompanying prospectus may be obtained, when
available, by visiting the SEC’s website at http://www.sec.gov.
This press release shall not constitute an offer
to sell or the solicitation of an offer to buy the securities, nor
shall there be any sales of the securities in any state or other
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to the registration or qualification under the
securities laws of any such state or other jurisdiction.
Bryan Cave Leighton Paisner LLP served as legal
advisor to Zevra, and Canaccord Genuity LLC served as exclusive
financial advisor to Zevra for the merger transactions. Pillsbury
Winthrop Shaw Pittman LLP served as legal advisor to Acer, and
William Blair & Company, LLC served as exclusive financial
advisor to Acer.
About Urea Cycle Disorders:Urea
cycle disorders (UCDs) are a group of rare, genetic disorders that
can cause harmful ammonia build-up in the blood, potentially
resulting in brain damage and neurocognitive impairments, if
ammonia levels are not controlled.i Any increase in ammonia over
time is serious. Therefore, it is important to adhere to any
dietary protein restrictions and have alternative medication
options to help control ammonia levels.
About OLPRUVA®:ACER-001 (sodium
phenylbutyrate) was approved for the treatment of certain UCDs in
December 2022 and has recently been marketed under the brand name,
OLPRUVA®. OLPRUVA (sodium phenylbutyrate) for oral suspension is a
prescription medicine indicated as adjunctive therapy to standard
of care, which includes dietary management, for the chronic
management of adult and pediatric patients weighing 20 kg (44
pounds) or greater and with a body surface area (BSA) of 1.2 m2 or
greater, with urea cycle disorders (UCDs) involving deficiencies of
carbamylphosphate synthetase (CPS), ornithine transcarbamylase
(OTC), or argininosuccinic acid synthetase (AS). Please see
Important Safety Information and full Prescribing Information,
including Patient Information.
Important Safety
Information:Certain medicines may increase the level of
ammonia in your blood or cause serious side effects when taken
during treatment with OLPRUVA. Tell your doctor about all the
medicines you or your child take, especially corticosteroids,
valproic acid, haloperidol, and/or probenecid.
OLPRUVA can cause serious side effects,
including: 1) nervous system problems (neurotoxicity); symptoms
include sleepiness, tiredness, lightheadedness, vomiting, nausea,
headache, confusion; 2) low potassium levels in your blood
(hypokalemia) and 3) conditions related to swelling (edema).
OLPRUVA contains salt (sodium), which can cause swelling from salt
and water retention. Tell your doctor right away if you or your
child experience any of these symptoms. Your doctor may do certain
blood tests to check for side effects during treatment with
OLPRUVA. If you have certain medical conditions such as heart,
liver or kidney problems, are pregnant/planning to get pregnant or
breast-feeding, your doctor will decide if OLPRUVA is right for
you.
The most common side effects of OLPRUVA include
absent or irregular menstrual periods, decreased appetite, body
odor, bad taste or avoiding foods you ate prior to getting sick
(taste aversion). These are not all of the possible side effects of
OLPRUVA. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
About Zevra Therapeutics:Zevra
Therapeutics is a rare disease company melding science, data, and
patient need to create transformational therapies for diseases with
limited or no treatment options. With unique, data-driven clinical,
regulatory, and commercialization strategies, the Company is
overcoming complex drug development challenges to bring much-needed
therapies to patients. With both regulatory and clinical-stage
product candidates, the Company is building its commercial
capability to make new therapies available to the rare disease
community.
Expanded access programs are made available by
Zevra Therapeutics and its affiliates and are subject to the
Company's Expanded Access Program (EAP) policy as published on its
website at www.zevra.com. Participation in these programs is
subject to the laws and regulations of each jurisdiction under
which each respective program is operated. Eligibility for
participation in any such program is at the treating physician's
discretion.
Cautionary Note Concerning
Forward-Looking Statements:This press release may contain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements include all statements that do not relate solely to
historical or current facts, and which can be identified by the use
of words such as "may," "will," "expect," "project," "estimate,"
"anticipate," "plan," "believe," "potential," "should," "continue,"
"could," "intend," "target," "predict," or the negative versions of
those words or other comparable words or expressions, although not
all forward-looking statements contain these identifying words or
expressions. Forward-looking statements are not guarantees of
future actions or performance. These forward-looking statements
include without limitation statements regarding the benefits of,
and synergies related to the merger transaction, the financial and
operating performance of the combined company following the merger,
potential strategic implications as a result of the merger
transaction, Zevra’s path to profitability, Zevra’s strategic and
product development objectives, including with respect to becoming
a leading, commercially-focused rare disease company, Zevra’s plans
to build out commercial teams for products or product candidates,
Zevra’s commercial infrastructure investments and the impact of the
transaction on them, Zevra’s industry, plans, goals and
expectations concerning market position, future operations and
other financial and operating information, and the potential for
achievement of the milestones that would trigger cash payments
pursuant to the CVRs issued to the Acer stockholders.
Forward-looking statements are based on information currently
available to Zevra and its current plans or expectations, and are
subject to several known and unknown uncertainties, risks, and
other important factors that may cause actual results, performance,
or achievements to be materially different from any future results,
performance, or achievements expressed or implied by the
forward-looking statements, including, but not limited to,
uncertainties involving the following: responses of competitors to
the combined company resulting from the transaction; unexpected
costs, charges or expenses of the combined company following the
completion of the transaction; the ability of Zevra to successfully
integrate Acer’s operations, products, product candidates and
technology; the ability of Zevra to implement its plans, forecasts
and other expectations with respect to Acer’s business after the
completion of the transaction and realize additional opportunities
for growth and innovation; the ability of Zevra to realize the
anticipated synergies and related benefits from the transaction in
the anticipated amounts or within the anticipated timeframes or at
all; and the ability to maintain relationships with Zevra’s and
Acer’s respective employees, customers, other business partners and
governmental authorities. These and other important factors are
described in detail in the “Risk Factors” section of Zevra’s and
Acer’s Annual Reports on Form 10-K for the year ended December
31, 2022, as updated in Zevra’s and Acer’s Quarterly Reports on
Form 10-Q for the quarter ended September 30, 2023, and
Zevra’s and Acer’s other filings with the Securities and
Exchange Commission. While Zevra may elect to update such
forward-looking statements at some point in the future, it
disclaims any obligation to do so, except as required by law, even
if subsequent events cause their respective views to change.
Although Zevra believes the expectations reflected in such
forward-looking statements are reasonable, it cannot assure that
such expectations will prove correct. These forward-looking
statements should not be relied upon as representing Zevra’s views
as of any date after the date of this press release.
Zevra Contacts:
Nichol Ochsner+1 (732) 754-2545nochsner@zevra.com
Janine Bogris+1 (201) 245-6838Janine.bogris@canalecomm.com
_____________________
i Ah Mew N, et al. Urea cycle disorders overview [updated June
22, 2017]. In: Adam MP, Ardinger HH, Pagon RA, et al, eds.
GeneReviews® [Internet]. University of Washington; 1993-2022.
Accessed March 20, 2022.
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