Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
10 January 2023 - 12:01AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO SECTION 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of January, 2023
Commission File Number: 001-36815
Ascendis Pharma A/S
(Exact Name of Registrant as Specified in Its
Charter)
Tuborg Boulevard 12
DK-2900
Hellerup
Denmark
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file
annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form
40-F ☐
Indicate by check mark if the registrant is submitting the
Form 6-K in paper as
permitted by Regulation S-T
Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the
Form 6-K in paper as
permitted by Regulation S-T
Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
This report on Form 6-K shall be deemed to be
incorporated by reference into the registration statements on
Form S-8 (Registration
Numbers 333-203040,
333-210810, 333-211512, 333-213412, 333-214843, 333-216883, 333-228576, 333-254101 and 333-261550) and Form F-3 (Registration Numbers
333-209336, 333-211511, 333-216882, 333-223134, 333-225284 and 333-256571) of Ascendis Pharma A/S (the
“Company”) (including any prospectuses forming a part of such
registration statements) and to be a part thereof from the date on
which this report is filed, to the extent not superseded by
documents or reports subsequently filed or furnished.
On January 8, 2023, the Company announced that it will provide
an update on its Vision 3x3 strategic roadmap and planned 2023 key
corporate milestones at the 41st Annual J.P. Morgan Health
Conference. Details of the update are outlined below.
Key Updates
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During the fourth quarter, 2022, the Company completed recruitment
into the Phase 3 foresiGHt Trial in adult growth hormone deficiency
(GHD). Topline results from foresiGHt are expected in the fourth
quarter of 2023.
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During the third quarter of 2023, the Company anticipates
completing enrollment in New InsiGHTS, a Phase 2 trial evaluating
the safety and efficacy of TransCon hGH in patients with Turner
Syndrome.
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First European SKYTROFA® (lonapegsomatropin)
commercial launch planned in Germany for the third quarter of
2023.
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SKYTROFA®
(lonapegsomatropin-tcgd) U.S preliminary, unaudited fourth quarter
2022 revenue is expected to be approximately €17.1 million.
This includes an estimated negative foreign currency translation
impact of €0.4 million, compared to a benefit of
€0.5 million in the third quarter of 2022.
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Phase 3 PaTHway Japan trial achieved its primary objectives;
topline results consistent with North American and EU trials.
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FDA Priority Review continues for use in adult patients with
hypoparathyroidism, with an April 30, 2023 PDUFA date; if
approved, U.S. commercial launch planned in the second quarter of
2023.
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Enrollment opened in January 2023 for U.S. Expanded Access Program
(EAP).
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European Commission decision anticipated during the fourth quarter
of 2023; if approved, EU commercial launch planned shortly
thereafter.
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Once-weekly TransCon PTH in preclinical development for patients on
stable daily TransCon PTH dose.
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First-ever randomized, double-blind, placebo-controlled Phase 2
trial (ACcomplisH) suggests a potential for safety, efficacy,
tolerability, and convenience in children with achondroplasia as
young as two years of age; all 57 patients currently remain in the
trial with treatment duration up to 3 years.
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During the second quarter of 2023, the Company expects to complete
enrollment in ApproaCH, a global randomized, double-blind,
placebo-controlled Phase 2b trial in children ages 2–11 years with
achondroplasia. The trial targets enrollment of ~80 patients.
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During the third quarter of 2023, the Company expects to submit an
IND or similar in children under the age of two years with
achondroplasia.
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TransCon TLR7/8 Agonist:
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Reported topline data from the dose escalation portion of the Phase
1/2 transcendIT-101 Trial
at SITC 2022. Early signs of clinical activity were observed in
patients receiving TransCon TLR7/8 Agonist as monotherapy or in
combination with pembrolizumab.
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Enrollment in transcendIT-101 continues with dose
expansion focused on investigating TransCon TLR7/8 Agonist in
combination with pembrolizumab in four cancer types.
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The Phase 1/2 IL-ßeliege
Trial evaluating TransCon IL-2 ß/g monotherapy in patients with locally
advanced or metastatic solid tumors continues to enroll patients.
Results from monotherapy dose escalation are expected during the
first quarter of 2023.
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Ophthalmology selected as the third therapeutic area:
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In vivo data demonstrates, TransCon Hydrogel Platform supports
continuous local drug release over at least 6 months supporting
twice yearly administration.
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TransCon RBZ (ranibizumab) selected as the first product
candidate.
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Forward-Looking Statements
This press release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, included in this press release
regarding Ascendis’ future operations, plans and objectives of
management are forward-looking statements. Examples of such
statements include, but are not limited to, statements relating to
(i) the expected regulatory approval and launch of TransCon
PTH in 2023, (ii) the timing and announcement of top-line results
from the foresiGHt Trial and the Phase 1/2 IL-ßeliege Trial, (iii) the timing of
completion of patient enrollment in the New InsiGHTS Trial and the
ApproaCH Trial (iv) Ascendis’ PDUFA date of April 30,
2023 with respect to the FDA’s Priority Review of TransCon PTH,
(v) the expected launch of TransCon hGH in Europe in 2023,
(vi) Ascendis’ unaudited preliminary financial information for the
fiscal year ended December 31, 2022, (vii) Ascendis’
expectations regarding the timing of its regulatory approvals,
submissions, applications, protocols, clinical trials and the
results thereof, (viii) Ascendis’ ability to apply its
TransCon platform to build a leading, fully integrated global
biopharma company, and (ix) Ascendis’ use of its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis may not actually achieve the plans, carry out the
intentions or meet the expectations or projections disclosed in the
forward-looking statements and you should not place undue reliance
on these forward-looking statements. Actual results or events could
differ materially from the plans, intentions, expectations and
projections disclosed in the forward-looking statements. Various
important factors could cause actual results or events to differ
materially from the forward-looking statements that Ascendis makes,
including the following: dependence on third party manufacturers
and distributors to supply TransCon hGH and the SKYTROFA® Auto-Injector for
commercial sales in the U.S. and other study drug for clinical
studies; unforeseen safety or efficacy results in its oncology
programs, TransCon hGH, TransCon PTH and TransCon CNP or other
development programs; unforeseen expenses related to
commercialization of TransCon hGH in the U.S., the co-pay program
and the further development of TransCon hGH; expenses related to
the development and potential commercialization of its oncology
programs, TransCon hGH, TransCon PTH and TransCon CNP or other
development programs; unforeseen selling, general and
administrative expenses, other research and development expenses
and Ascendis’ business generally; delays in the development of its
oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or
other development programs related to manufacturing, regulatory
requirements, speed of patient recruitment or other unforeseen
delays; dependence on third party manufacturers to supply study
drug for planned clinical studies; Ascendis’ ability to obtain
additional funding, if needed, to support its business activities;
the impact of international economic, political, legal, compliance,
social and business factors, including inflation, and the effects
on its business from the worldwide COVID-19 pandemic and the
ongoing conflict in the region surrounding Ukraine and Russia. For
a further description of the risks and uncertainties that could
cause actual results to differ from those expressed in these
forward-looking statements, as well as risks relating to Ascendis’
business in general, see Ascendis’ Annual Report on Form 20-F filed
with the U.S. Securities and Exchange Commission (SEC) on
March 2, 2022 and Ascendis’ other future reports filed with,
or submitted to, the SEC. Forward-looking statements do not reflect
the potential impact of any future licensing, collaborations,
acquisitions, mergers, dispositions, joint ventures, or investments
that Ascendis may enter into or make. The preliminary financial
information set forth in this press release is subject to the
completion of Ascendis’ audit process and is subject to change. The
estimated preliminary results included in this press release should
not be viewed as a substitute for Ascendis’ annual financial
statements prepared in accordance with International Financial
Reporting Standards. Ascendis does not assume any obligation to
update any forward-looking statements, except as required by
law.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, as amended, the registrant has duly caused this report to be
signed on its behalf by the undersigned hereunto duly
authorized.
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Ascendis Pharma A/S
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Date: January 9, 2023 |
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By: |
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/s/ Michael Wolff Jensen
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Michael Wolff Jensen |
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Senior Vice President, Chief Legal Officer |
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