Item 7.01. Regulation FD Disclosure.
Curis, Inc. ("Curis" or the "Company") will present the updates described in
Item 8.01 of this Current Report on Form 8-K on a conference call to be held on
January 6, 2022. A copy of this presentation is attached as Exhibit 99.1 to this
Current Report on Form 8-K. The attached presentation is incorporated herein by
reference.
The information in this Item 7.01 (including Exhibit 99.1 attached hereto) shall
not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act
of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that
section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933 or the Exchange Act, except as expressly set forth by
specific reference in such a filing.
Item 8.01. Other Events.
On January 6, 2022, the Company issued a press release announcing updated
clinical data from its ongoing open label Phase 1/2 dose escalation and
expansion study of CA-4948, a novel, small molecule IRAK-4 inhibitor, as a
monotherapy in patients with relapsed or refractory ("R/R") acute myeloid
leukemia or high risk myelodysplastic syndromes, as well as initial safety,
pharmacokinetic and pharmacodynamic data from its Phase 1 dose escalation study
of CI-8993, a monoclonal antibody targeting VISTA for patients with R/R solid
tumors.
The full text of the press release issued in connection with this announcement
is attached as Exhibit 99.2 to this Current Report on Form 8-K and incorporated
herein by reference.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K and the exhibits attached hereto contain
forward-looking statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995, including, without limitation, any statements
concerning expectations of the potential for Curis's proprietary drug candidates
CA-4948 and CI-8993, including with respect to the potency, anti-cancer
activity, durability and tolerability of CA-4948 and CI-8993; future studies
with respect to CA-4948 and CI-8993; the potential advantages and benefits of
CA-4948, CI-8993 and checkpoint inhibitors over other therapies; Curis's plans
to advance its development programs for CA-4948 and CI-8993, including with
respect to anticipated results, clinical trials, regulatory and
commercialization plans and timelines; and statements of assumptions underlying
any of the foregoing. Forward-looking statements may contain the words
"believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates,"
"assumes," "predicts," "projects," "targets," "will," "may," "would," "could,"
"should," "continue," "potential," "focus," "strategy," "mission," or similar
expressions. These forward-looking statements are not guarantees of future
performance and involve risks, uncertainties, assumptions and other important
factors that may cause actual results to be materially different from those
indicated by such forward-looking statements. For example, Curis may experience
adverse results, delays and/or failures in its drug development programs and may
not be able to successfully advance the development of its drug candidates in
the time frames it projects, if at all. Curis's drug candidates may cause
unexpected toxicities, fail to demonstrate sufficient safety and efficacy in
clinical studies and/or may never achieve the requisite regulatory approvals
needed for commercialization. Favorable results seen in preclinical studies and
early clinical trials of Curis's drug candidates may not be replicated in later
trials. There can be no guarantee that the collaboration agreements with
Aurigene Discovery Technologies Limited and ImmuNext, Inc., or the Cooperative
Research and Development Agreement with the National Cancer Institute, will
continue for their full terms, that Curis or its collaborators will each
maintain the financial and other resources necessary to continue financing their
respective portions of the research, development and commercialization costs, or
that the parties will successfully discover, develop or commercialize drug
candidates under the collaborations. Regulatory authorities may determine to
delay or restrict the ability of Genentech Inc. ("Genentech"), a member of the
Roche Group ("Roche"), and/or Roche's ability to continue to develop or
commercialize Erivedge® in advanced basal cell carcinoma ("BCC"). Erivedge may
not demonstrate sufficient or any activity to merit its further development in
disease indications other than BCC. Competing drugs may be developed that are
superior to Erivedge. In connection with its agreement with entities managed by
Oberland Capital Management, LLC, Curis faces risks relating to the transfer and
encumbrance of certain royalty and royalty-related payments on commercial sales
of Erivedge, including the risk that, in the event of a default by Curis or its
wholly-owned subsidiary, Curis could lose all retained rights to future royalty
and royalty-related payments, Curis could be required to repurchase such future
royalty and royalty-related payments at a price that is a multiple of the
payments it has received, and its ability to enter into future arrangements may
be
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inhibited, all of which could have a material adverse effect on its business,
financial condition and stock price. Curis will require substantial additional
capital to fund its business. If it is not able to obtain sufficient funding, it
will be forced to delay, reduce in scope or eliminate some of its research and
development programs, including related clinical trials and operating expenses,
potentially delaying the time to market for, or preventing the marketing of, any
of its product candidates, which could adversely affect its business prospects
and its ability to continue operations, and would have a negative impact on its
financial condition and its ability to pursue its business strategies. Curis
faces substantial competition. Curis and its collaborators face the risk of
potential adverse decisions made by the FDA and other regulatory authorities,
investigational review boards, and publication review bodies. Curis may not
obtain or maintain necessary patent protection and could become involved in
expensive and time-consuming patent litigation and interference proceedings.
Unstable market and economic conditions, natural disasters, public health
crises, political crises and other events outside of Curis's control could
significantly disrupt its operations or the operations of third parties on which
Curis depends, and could adversely impact Curis's operating results and its
ability to raise capital. For example, the COVID-19 pandemic may result in
closures of third-party facilities, impact enrollment in clinical trials or
impact sales of Erivedge by Genentech and/or Roche. The extent to which the
COVID-19 pandemic may impact Curis's business or operating results is uncertain.
Other important factors that may cause or contribute to actual results being
materially different from those indicated by forward-looking statements include
the factors set forth under the captions "Risk Factor Summary" and "Risk
Factors" in Curis's most recent Annual Report on Form 10-K and Quarterly Report
on Form 10-Q, and the factors that are discussed in other filings that Curis
periodically makes with the Securities and Exchange Commission. In addition, any
forward-looking statements represent the views of Curis only as of the date of
this Current Report on Form 8-K and should not be relied upon as representing
Curis's views as of any subsequent date. Curis disclaims any intention or
obligation to update any of the forward-looking statements after the date of
this Current Report on Form 8-K whether as a result of new information, future
events or otherwise, except as may be required by law.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 Presentation
99.2 Press Release dated January 6, 2022
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document)
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