XOMA Adds Economic Interests in Three First-in-Category Assets to its Royalty and Milestone Portfolio Including XACIATO™ (clindamycin phosphate) Vaginal Gel 2%
April 30 2024 - 7:30AM
XOMA Corporation (NASDAQ: XOMA) announced today it has acquired an
economic interest in three women’s health assets - XACIATO™
(clindamycin phosphate) vaginal gel 2%, Ovaprene®, and Sildenafil
Cream, 3.6% - from Daré Bioscience, Inc., for an upfront payment of
$22 million. XACIATO™ is approved by the U.S. Food and Drug
Administration (FDA) for the treatment of bacterial vaginosis (BV)
in females 12 years of age and older. In 2022, Daré entered
into a license agreement with Organon, which initiated XACIATO™
commercial marketing activities in the fourth quarter of
2023.
“XACIATO™, an important therapy, becomes the fifth commercial
asset in XOMA’s royalty portfolio, and our royalty monetization
transaction with Daré also adds two first-in-category Phase 3
royalty assets that have the potential to create additional value
for our shareholders. Each of the three assets represents a
meaningful advance in the women’s health category that has
typically been under-represented and has significant growth
potential,” stated Brad Sitko, Chief Investment Officer at
XOMA. “XOMA structured an attractive, non-dilutive royalty
capital solution that provides Daré with additional financial
resources to advance its pipeline through key catalysts and aligns
with its stockholders, enabling them to participate in the future
value created by XACIATO™, Ovaprene®, and Sildenafil
Cream.”
Under the terms of the agreement, XOMA will receive the
remaining royalties related to XACIATO™ not already included in
Daré’s December 2023 royalty-backed financing agreement, which
equates to low to high single-digit royalties on net sales.
XOMA also is entitled to potential milestone payments based on the
commercial success of XACIATO. Additionally, XOMA has
acquired an interest in a potential milestone and a low
single-digit synthetic royalty on Ovaprene®, as well as a low
single-digit synthetic royalty on Sildenafil Cream, 3.6%.
Upon achieving a pre-specified return threshold, XOMA will make
upside-sharing milestone payments to Daré.
AdvisorsGibson, Dunn & Crutcher LLP served
as XOMA’s legal advisor, while Daré was advised by Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo, P.C. TD Cowen, a division of TD
Securities, acted as exclusive financial advisor to
Daré.
About XACIATO™ (clindamycin phosphate) vaginal gel
2%XACIATO vaginal gel is a prescription medicine used to
treat bacterial vaginal infections in females 12 years of age and
older, which is under a global license agreement with
Organon. For more information, including important safety
information, please visit www.xaciato.com.
About Ovaprene®Ovaprene® is a novel
investigational hormone-free monthly intravaginal contraceptive
designed to be an easy-to use monthly option and prevent pregnancy
by releasing a locally acting, non-hormonal agent, which impedes
sperm motility, and physically blocks sperm from entering the
cervical canal with its unique knitted polymer barrier. The
novel combination of these complementary approaches has the
potential to produce efficacy consistent with existing short-acting
hormone birth control options (pills, patches, vaginal ring),
without the use of hormones. U.S. commercial rights to
Ovaprene® are under a license agreement with Bayer.
About Sildenafil Cream, 3.6%Sildenafil, a
phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in
a tablet for oral administration currently marketed under the brand
name Viagra® for the treatment of erectile dysfunction in
men. Sildenafil Cream is an investigational, proprietary
cream formulation of sildenafil designed for topical administration
to the vulvar-vaginal tissue on demand to increase genital blood
flow and provide improvements in the female genital arousal
response, while avoiding systemic side effects observed with oral
formulations of sildenafil.
About XOMA CorporationXOMA is a biotechnology
royalty aggregator playing a distinctive role in helping biotech
companies achieve their goal of improving human health. XOMA
acquires the potential future economics associated with
pre-commercial therapeutic candidates that have been licensed to
pharmaceutical or biotechnology companies. When XOMA acquires
the future economics, the seller receives non-dilutive,
non-recourse funding they can use to advance their internal drug
candidate(s) or for general corporate purposes. The Company
has an extensive and growing portfolio of assets (asset defined as
the right to receive potential future economics associated with the
advancement of an underlying therapeutic candidate). For more
information about the Company and its portfolio, please visit
www.xoma.com or follow the Company on LinkedIn.
Forward-Looking Statements/Explanatory
NotesCertain statements contained in this press release
are forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, including statements regarding the timing and
amount of potential commercial payments to XOMA and other
developments related to XACIATO™, Ovaprene®, and Sildenafil Cream,
3.6%. In some cases, you can identify such forward-looking
statements by terminology such as “anticipate,” “intend,”
“believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,”
“will,” “would,” “could” or “should,” the negative of these terms
or similar expressions. These forward-looking statements are
not a guarantee of XOMA’s performance, and you should not
place undue reliance on such statements. These statements are
based on assumptions that may not prove accurate, and actual
results could differ materially from those anticipated due to
certain risks inherent in the biotechnology industry, including
those related to the fact that our product candidates subject to
out-license agreements are still being developed, and our licensees
may require substantial funds to continue development which may not
be available; we do not know whether there will be, or will
continue to be, a viable market for the products in which we have
an ownership or royalty interest; if the therapeutic product
candidates to which we have a royalty interest do not receive
regulatory approval, and our third-party licensees will not be able
to market them. Other potential risks to XOMA meeting these
expectations are described in more detail in XOMA's most recent
filing on Form 10-K and in other filings with the Securities and
Exchange Commission. Consider such risks carefully when
considering XOMA's prospects. Any forward-looking statement
in this press release represents XOMA's beliefs and assumptions
only as of the date of this press release and should not be relied
upon as representing its views as of any subsequent date.
XOMA disclaims any obligation to update any forward-looking
statement, except as required by applicable law.
EXPLANATORY NOTE: Any references to “portfolio” in this press
release refer strictly to milestone and/or royalty rights
associated with a basket of drug products in development. Any
references to “assets” in this press release refer strictly to
milestone and/or royalty rights associated with individual drug
products in development.
As of the date of this press release, all assets in XOMA’s
milestone and royalty portfolio, except VABYSMO® (faricimab),
OJEMDA™ (tovorafenib), XACIATO™ (clindamycin phosphate) vaginal gel
2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA®
(sufentanil sublingual tablet), are investigational
compounds. Efficacy and safety have not been
established. There is no guarantee that any of the
investigational compounds will become commercially
available.
XOMA Investor Contact |
XOMA Media Contact |
Juliane Snowden |
Kathy Vincent |
XOMA Corporation |
KV Consulting & Management |
+1 646-438-9754 |
+1 310-403-8951 |
juliane.snowden@xoma.com |
kathy@kathyvincent.com |
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