<SEC-DOCUMENT>0001171843-24-000110.txt : 20240108
<SEC-HEADER>0001171843-24-000110.hdr.sgml : 20240108
<ACCEPTANCE-DATETIME>20240108061340
ACCESSION NUMBER:		0001171843-24-000110
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20240108
FILED AS OF DATE:		20240108
DATE AS OF CHANGE:		20240108

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NOVARTIS AG
		CENTRAL INDEX KEY:			0001114448
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			V8
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-15024
		FILM NUMBER:		24518210

	BUSINESS ADDRESS:	
		STREET 1:		LICHTSTRASSE 35
		CITY:			BASEL
		STATE:			V8
		ZIP:			CH 4056
		BUSINESS PHONE:		01141613241111

	MAIL ADDRESS:	
		STREET 1:		LICHTSTRASSE 35
		CITY:			BASEL
		STATE:			V8
		ZIP:			CH 4056
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<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>UNITED STATES</B></P>

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<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Washington, D.C. 20549</B></P>

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<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>FORM 6-K</B></P>

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<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><b>Report on Form 6-K dated January 8, 2024</b></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>(Commission File No. 1-15024)</B></P>

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<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">____________________</P>

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<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>Novartis AG</B></P>

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<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Switzerland</B></P>

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    <TD STYLE="width: 47%; font-size: 10pt"><FONT STYLE="font-size: 10pt">Form 40-F:&nbsp;&#9744;</FONT></TD></TR>
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    <TD STYLE="width: 47%"><FONT STYLE="font-size: 10pt"><B>No</B>:&nbsp;<B>&#9746;</B></FONT></TD></TR>
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<P STYLE="font-size: 10pt; margin: 0pt 0 3pt">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
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<P STYLE="font-size: 10pt; margin: 0pt 0 3pt">Indicate by check mark whether the registrant by furnishing the information contained
in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
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    <TD STYLE="width: 33%"><p style="color: rgb(4,96,169); font: 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><b>Novartis&nbsp;International&nbsp;AG<BR>
                           Novartis&nbsp;Global Communications</b><BR>
                           <font style="color: windowtext">CH-4002 Basel</font><BR>
                           <font style="color: windowtext">Switzerland</font></P>

<p style="color: #0460A9; font: bold 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

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<p style="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><font style="font-size: 10pt">&nbsp;</font></p>

<P STYLE="color: #002068; font-size: 10pt; margin: 0pt 0"><FONT STYLE="font-size: 14pt"><B>MEDIA &amp; INVESTOR RELEASE</B></FONT></p>

<P STYLE="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><FONT STYLE="font-size: 10pt"></FONT></P>

<P STYLE="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><font style="font-size: 10pt">&nbsp;</font></p>



<P STYLE="font-size: 10pt; margin: 0pt 0; color: #0460A9"><FONT STYLE="font-size: 12pt"><B>Novartis&nbsp;Scemblix<SUP>&reg;</SUP> shows
superior major molecular response (MMR) rates vs. standard-of-care TKIs in Phase III trial for newly diagnosed patients with chronic
myeloid leukemia</B></FONT></P>

<P STYLE="color: #0460A9; font-size: 10pt; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><FONT STYLE="font-size: 11pt"><B>Ad hoc announcement pursuant to Art. 53</B></FONT></P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><FONT STYLE="font-size: 11pt"><B>&nbsp;</B></FONT><B> </B></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD><I>ASC4FIRST trial&nbsp;met both primary endpoints with clinically meaningful and statistically significant results; Scemblix<SUP>&reg;</SUP>
(asciminib) shows superior&nbsp;MMR rates at&nbsp;week 48 vs. standard-of-care TKIs (imatinib, nilotinib,&nbsp;dasatinib, and bosutinib)&nbsp;in
newly diagnosed Ph</I>+<I>CML-CP patients<SUP>1</SUP></I></TD></TR></TABLE>

<P STYLE="margin: 0pt 0 0pt 0.5in; font-size: 10pt"><I>&nbsp;</I></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD><I>Scemblix demonstrated a favorable safety and tolerability profile with fewer adverse events (AEs) and treatment discontinuations
vs. standard-of-care TKIs; no new safety signals were observed<SUP>1</SUP></I></TD></TR></TABLE>

<P STYLE="margin: 0pt 0 0pt 0.5in; font-size: 10pt"><I>&nbsp;</I></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD><I>With current standard-of-care TKIs, more than 60% of newly diagnosed patients with CML fail to meet molecular response goals at
one year; intolerance and AEs remain a primary reason for discontinuing TKI therapy, with discontinuation rates due to AEs of up to 25%
by five years<SUP>2-13</SUP></I></TD></TR></TABLE>

<P STYLE="margin: 0pt 0; font-size: 10pt"><I>&nbsp;</I></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD><FONT STYLE="font-size: 10pt"><I>Data will be presented at an upcoming medical conference and submitted to regulatory authorities
in 2024</I></FONT></TD></TR></TABLE>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><B>Basel, January 08, 2024</B> &mdash; Novartis today announced positive results from the primary
analysis of ASC4FIRST, a pivotal Phase III trial comparing Scemblix<SUP>&reg;</SUP> (asciminib) with investigators&rsquo; choice of tyrosine
kinase inhibitor (TKI) treatment in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic
phase (Ph+ CML-CP)<SUP>1</SUP>. ASC4FIRST is the first and only randomized head-to-head Phase III trial comparing a CML treatment vs.
approved standard-of-care first- and second-generation TKIs<SUP>1</SUP>.</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">The trial met both primary endpoints of major molecular response (MMR) rate for Scemblix compared
to investigator-selected TKIs (imatinib, nilotinib, dasatinib, and bosutinib) and compared to imatinib, demonstrating clinically meaningful
and statistically significant results for both endpoints<SUP>1</SUP>. Scemblix showed a favorable safety and tolerability profile with
fewer adverse events (AEs) and treatment discontinuations vs. investigator selected standard-of-care TKIs<SUP>1</SUP>. The ASC4FIRST data
showed no new safety signals compared to the established safety profile of Scemblix<SUP>1,14</SUP>.</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&ldquo;We are very encouraged by these results given that a significant proportion of patients
with newly diagnosed chronic myeloid leukemia, or CML, do not achieve their treatment goals,&rdquo; said Prof. Tim Hughes, MD, South Australian
Health &amp; Medical Research Institute (SAHMRI). &ldquo;There remains a significant need in first-line therapy of CML for tolerable treatment
options, allowing people with CML to balance their treatment alongside their quality of life.&rdquo;</P>

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<P STYLE="margin: 0pt 0; font-size: 10pt">Improvements in treatment have transformed CML into a chronic disease, with a life expectancy
similar to that of the general population, making tolerability an important treatment goal<SUP>9</SUP>. While many patients with CML may
benefit from available TKI therapy, intolerance and AEs remain a primary reason for TKI therapy discontinuation, with discontinuation
rates due to AEs of up to 25% by five years<SUP>2-6</SUP>. Additionally, over 60% of newly diagnosed CML patients fail to meet 12-month
molecular response goals <SUP>5-13</SUP>.</P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><I><SUP>&nbsp;</SUP></I></P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><FONT STYLE="color: windowtext">&ldquo;We are excited that Scemblix may help people newly diagnosed
with CML achieve their treatment goals while continuing to live their lives,&rdquo; said Shreeram Aradhye, M.D., President, Development
and Chief Medical Officer, Novartis. &ldquo;Given the chronic nature of their condition, patients often need to be on TKI therapy for
many years, so treatment options that are well tolerated and highly </FONT>efficacious <FONT STYLE="color: windowtext">are crucial to
support adherence. This study outcome builds on our 20-year legacy in CML innovation as we strive to continue to address the remaining
unmet needs for people living with this blood cancer.&rdquo;</FONT></P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">The trial remains ongoing, with the next scheduled data readout planned for week 96, which will
evaluate the key secondary endpoint (MMR at week 96) as well as additional secondary endpoints.</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">Details will be presented at an upcoming medical conference and included as part of regulatory
submissions in 2024.</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><B>About ASC4FIRST Phase III Clinical Trial</B></P>

<P STYLE="margin: 0pt 0; font-size: 10pt">ASC4FIRST (NCT04971226) is a Phase III, head-to-head, multi-center, open-label, randomized study
of oral Scemblix<SUP>&reg;</SUP> 80 mg QD versus investigator-selected first- or second-generation TKI (imatinib, nilotinib, dasatinib,
or bosutinib) in 405 adult patients with newly diagnosed Ph+ CML-CP<SUP>1</SUP>. The two primary endpoints of the study are to compare
efficacy of asciminib vs. investigator-selected TKI and to compare efficacy vs that of TKI within the stratum of participants with imatinib
as pre-randomization selected TKI, based on proportion of patients that achieve MMR at week 48<SUP>1</SUP>. The study remains ongoing
with a key secondary endpoint of proportion of patients that achieve MMR at week 96 and a safety endpoint of discontinuation of study
treatment due to an AE (TTDAE) by week 96. The study also assesses additional secondary safety and efficacy endpoints, including MMR,
MR4, MR4.5, complete hematological response (CHR) and <I>BCR::ABL1</I> &#8804;1% at and by all scheduled data collection time points;
duration of and time to first MMR, MR4 and MR4.5; time to treatment failure; event-free survival, failure-free survival, progression-free
survival, and overall survival<SUP>1</SUP>.</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><B>About Scemblix<SUP>&reg;</SUP> (asciminib)</B></P>

<P STYLE="margin: 0pt 0; font-size: 10pt">Scemblix<SUP>&reg;</SUP> is the first CML treatment that works by specifically targeting the
ABL myristoyl pocket<SUP>15,16</SUP> and was intentionally designed to be highly specific and minimize off-target kinase mediated effects,
which translates into an improved safety and tolerability profile compared to current standard of care.</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">Scemblix is approved in more than 60 countries, including the US and the EU, to treat adults
with Ph+ CML-CP who have previously been treated with two or more TKIs<SUP>14,19</SUP>. In some countries including the US, Scemblix is
also approved in patients with Ph+ CML-CP with the T315I mutation<SUP>2-14,18,19</SUP>.</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">Scemblix represents an important potential treatment option for patients who experience resistance
and/or intolerance to currently available TKI therapies, and it is being studied across multiple treatment lines for Ph+ CML-CP, both
as monotherapy and in combination<SUP>15-18,20-33</SUP>.<B>&nbsp;</B></P>

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<P STYLE="margin: 0pt 0; font-size: 10pt"><B></B></P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><B>About Novartis Commitment to CML</B></P>

<P STYLE="margin: 0pt 0; font-size: 10pt">Novartis has a long-standing scientific commitment to patients living with CML. For more than
two decades, our bold science has helped transform CML into a chronic, versus a life-limiting, condition for many patients. Despite these
advancements, there&rsquo;s still work to be done. We continue to research ways to target the disease more selectively and to address
the challenges of not reaching treatment efficacy goals, experiencing treatment resistance and/or intolerance that many patients face.
Our legacy inspires our future innovation &ndash; we continue to lead the way in developing novel medicines to address serious unmet needs
in CML. Our commitment also goes beyond science. Our collaboration with the Max Foundation has provided access to Glivec, Tasigna and
now Scemblix, starting over 20 years ago, and delivering tremendous patient impact in low and middle income countries, with 90,000 patients
supported to date.</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><B>Disclaimer</B></P>

<P STYLE="margin: 0pt 0; font-size: 10pt">This press release contains forward-looking statements within the meaning of the United States
Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as &ldquo;potential,&rdquo;
&ldquo;can,&rdquo; &ldquo;will,&rdquo; &ldquo;planned,&rdquo; &ldquo;may,&rdquo; &ldquo;commitment,&rdquo; &ldquo;remain,&rdquo; &ldquo;goals,&rdquo;
&ldquo;upcoming,&rdquo; &ldquo;excited,&rdquo; &ldquo;potentially,&rdquo; &ldquo;continuing,&rdquo; &ldquo;continue,&rdquo; &ldquo;strive,&rdquo;
&ldquo;ongoing,&rdquo; &ldquo;to address,&rdquo; or similar terms, or by express or implied discussions regarding potential marketing
approvals, new indications or labeling for Scemblix, or regarding potential future revenues from Scemblix. You should not place undue
reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events,
and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize,
or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements.
There can be no guarantee that Scemblix will be submitted or approved for sale or for any additional indications or labeling in any market,
or at any particular time. Nor can there be any guarantee that Scemblix will be commercially successful in the future. In particular,
our expectations regarding Scemblix could be affected by, among other things, the uncertainties inherent in research and development,
including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation
generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement
pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection;
the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the
effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data
security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis
AG&rsquo;s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release
as a result of new information, future events or otherwise.</P>

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<P STYLE="margin: 0pt 0; font-size: 10pt">Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve
and extend people&rsquo;s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease.
Our medicines reach more than 250 million people worldwide.</P>

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<P STYLE="margin: 0pt 0; font-size: 10pt"><FONT STYLE="color: windowtext">Reimagine medicine with us: Visit us at </FONT><B>https://www.novartis.com
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<P STYLE="font-size: 10pt; margin: 0pt 0"><FONT STYLE="font-size: 10pt"><B>References</B></FONT><B><FONT STYLE="font-size: 11pt">&nbsp;</FONT></B></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">1.</TD><TD>Novartis Data on File, 2024.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">2.</TD><TD>Cortes JE, et al. Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib.
Am J Hematol. 2016;91(12):1206-1214.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">3.</TD><TD>Garg RJ, et al. The use of nilotinib or dasatinib after failure to 2 prior tyrosine kinase inhibitors: long-term follow-up. Blood.
2009;114(20):4361-4368.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">4.</TD><TD>Steegmann JL., et al. European LeukemiaNet recommendations for the management and avoidance of adverse events of treatment in chronic
myeloid leukaemia. Leukemia. 2016;30:1648-1671.</TD></TR></TABLE>

<P STYLE="margin-top: 0; margin-bottom: 0"></P>

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<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">5.</TD><TD>Hochhaus A, et al. Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia. N Engl J Med. 2017;376: 917&ndash;927.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">6.</TD><TD>Cortes JE., et al. Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Na&iuml;ve Chronic Myeloid
Leukemia Patients Trial. J Clin Oncol. 2016;34:2333-2340.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">7.</TD><TD>Akard LP, et al. The &ldquo;Hit Hard and Hit Early&rdquo; Approach to the Treatment of Chronic Myeloid Leukemia: Implications of the
Updated National Comprehensive Cancer Network Clinical Practice Guidelines for Routine Practice. Clin Adv Hematol Oncol. 2013;11(7):421-432.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">8.</TD><TD>Cortes JE, et al. Ponatinib efficacy and safety in Philadelphia chromosome&ndash;positive leukemia: Final 5-year results of the phase
2 PACE trial. Blood. 2018;132(4):393-404.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">9.</TD><TD>Hochhaus A, et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34:966-984.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">10.</TD><TD>Hochhaus A, et al. Leukemia. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic
phase: 5-year update of the randomized ENESTnd trial. 2016;30:1044-1054.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">11.</TD><TD>Br&uuml;mmendorf TH, et al. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia: results from the
24-month follow-up of the BELA trial.Br J Haematol. 2015;168:69-81.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">12.</TD><TD>Cortes JE, et al. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial.
J Clin Oncol. 2018;36:231-237.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">13.</TD><TD>NCCN Clinical Practice Guidelines. Chronic Myeloid Leukemia. V2.2021.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">14.</TD><TD>Scemblix Summary of Product Characteristics, 2022.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">15.</TD><TD>Rea D, et al. A Phase 3, Open-Label, Randomized Study of Asciminib, a STAMP Inhibitor, vs Bosutinib in CML After&#8805; 2 Prior TKIs.
Blood. 2021. DOI: 10.1182/blood.2020009984. PMID: 34407542.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">16.</TD><TD>Cortes JE, et al. Asciminib, a First-in-Class STAMP Inhibitor, Provides Durable Molecular Response in Patients (pts) with Chronic
Myeloid Leukemia (CML) Harboring the T315I Mutation: Primary Efficacy and Safety Results from a Phase 1 Trial. Oral presentation at: ASH
Annual Meeting; Dec. 7, 2020.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">17.</TD><TD>Schoepfer J, et al. Discovery of Asciminib (ABL001), an Allosteric Inhibitor of the Tyrosine Kinase Activity of BCR-ABL1. J Med Chem.
2018;61(18):8120-8135.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">18.</TD><TD>Novartis Data on File, 2021.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">19.</TD><TD>Flis S, et al. Chronic myelogenous leukemia, a still unsolved problem: pitfalls and new therapeutic possibilities. Drug Des Devel
Ther. 2019;13:825-843.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">20.</TD><TD>Wylie AA, et al. The allosteric inhibitor ABL001 enables dual targeting of BCR&ndash;ABL1. Nature. 2017;543(7647):733-737.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">21.</TD><TD>Hughes TP, et al. Asciminib in Chronic Myeloid Leukemia after ABL Kinase Inhibitor Failure. N Engl J Med. 2019; 381(24):2315-2326.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">22.</TD><TD>Hughes TP, et al. Expanded Phase 1 Study of ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Reveals Significant and Durable Responses
in Patients with CML-Chronic Phase with Failure of Prior TKI Therapy. Poster presented at: ASH Annual Meeting &amp; Exposition; Dec. 5,
2016.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">23.</TD><TD>Ottmann OG, et al. ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Exhibits Safety and Promising Single- Agent Activity in a Phase
I Study of Patients with CML with Failure of Prior TKI Therapy. Blood. 2015;126(23):138.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">24.</TD><TD>Mauro MJ, et al. Combination of Asciminib Plus Nilotinib (NIL) or Dasatinib (DAS) in Patients (PTS) with Chronic Myeloid Leukemia
(CML): Results from a Phase 1 Study. Poster presented at: EHA Annual Meeting; June 15, 2019.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">25.</TD><TD>Cortes JE, et al. Combination Therapy Using Asciminib Plus Imatinib (IMA) in Patients (PTS) with Chronic Myeloid Leukemia (CML): Results
from a Phase 1 Study. Poster presented at: EHA Annual Meeting; June 15, 2019.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">26.</TD><TD>Manley P., et al. The specificity of asciminib, a potential treatment for chronic myeloid leukemia, as a myristate-pocket binding
ABL inhibitor and analysis of its interactions with mutant forms of BCR-ABL1 kinase. Leukemia Research. 2020;98.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">27.</TD><TD>ClinicalTrials.gov. 2017. Study of Efficacy of CML-CP Patients Treated with ABL001 Versus Bosutinib, Previously Treated With 2 or
More TKIs. [online] Available at: https://clinicaltrials.gov/ct2/show/NCT03106779.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">28.</TD><TD>ClinicalTrials.gov. 2021. A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP. [online]
Available at: https://clinicaltrials.gov/ct2/show/NCT04971226.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">29.</TD><TD>ClinicalTrials.gov. 2020. Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and WithoutT315I Mutation
(AIM4CML). [online] Available at: https://clinicaltrials.gov/ct2/show/NCT04666259.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">30.</TD><TD>ClinicalTrials.gov. 2018. Study of Efficacy And Safety Of Asciminib In Combination With Imatinib In Patients With Chronic Myeloid
Leukemia In Chronic Phase (CML-CP). [online] Available at: https://clinicaltrials.gov/ct2/show/NCT03578367.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">31.</TD><TD>ClinicalTrials.gov. 2021. Study of Efficacy and Safety of CML-CP Patients Treated With Asciminib Versus Best Available Therapy, Previously
Treated With 2 or More Tyrosine Kinase Inhibitors. [online] Available at: https://clinicaltrials.gov/ct2/show/NCT04795427.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">32.</TD><TD>ClinicalTrials.gov. 2014. A Phase I Study of Oral ABL001 in Patients With CML or Ph+ ALL. [online] Available at: https://clinicaltrials.gov/ct2/show/NCT02081378.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in">33.</TD><TD>ClinicalTrials.gov. 2021 Asciminib Treatment Optimization in &#8805; 3rd Line CML-CP. [online] Available at: https://clinicaltrials.gov/ct2/show/NCT04948333.</TD></TR></TABLE>

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<p style="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><font style="font-size: 10pt"><font style="color: Black"><b>&nbsp;</b></font></font></P>

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<P STYLE="font-size: 10pt; margin: 0.55pt 0 0">&nbsp;</P>

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<p style="font-size: 10pt; text-align: center; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>SIGNATURES</B></FONT></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant to
the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.</FONT></P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; background-color: white; font-size: 10pt">
<TR>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
    <TD COLSPAN="2"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Novartis AG</B></FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD></TR>
<TR>
    <TD STYLE="width: 52%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="width: 7%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="width: 25%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="width: 16%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD></TR>
<TR>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD></TR>
<TR>
    <TD><font style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Date: January 8, 2024</font></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By:</FONT></TD>
    <TD STYLE="border-bottom: black 1pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/ PAUL
    PENEPENT</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD></TR>
<TR>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Name:&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Paul Penepent</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD></TR>
<TR>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Title:</FONT></TD>
    <TD COLSPAN="2"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Head Group Financial Reporting and
    Accounting</FONT></TD></TR>
</TABLE>


<P STYLE="margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

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