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April 2024

Vol - 02 Issue - 05

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CXO MAGAZINE, APRIL 2024

CFO
FROM ASIA

A VisionaryFinancial Leader Driving
Biotech BreakthroughsM
Mutsuki Takano
Board Director and CFOof Heartseed Inc.
CXO MAGAZINE, APRIL 2024

utsuki Takano, a seasoned
financial leader renowned forhis strategic acumen, currently
holds the esteemed positions ofBoard Director and Chief Financial Officer atHeartseed Inc., an innovative biotechnology
firm at the forefront of medical advancements.
With a rich career spanning over two decades,
Takano's professional journey commenced
at Mitsui & Co., Ltd. in 2004, where hecultivated his expertise in risk management andinternational trade, laying the foundation for his
illustrious career trajectory into venture capital.
In July 2018, Takano embarked on atransformative phase in his career, joining
Promethera Biosciences SA, now rebranded
as Cellaion, as the Japan Branch General

Manager. His tenure at Promethera Biosciences
SA was marked by remarkable achievements,
particularly in fundraising, where his leadershipas the Japan Branch General Managerand Group CFO facilitated the successful
procurement of approximately Eur50 million.
This accomplishment underscored Takano's
adeptness in navigating intricate financial
landscapes with finesse.
Driven by an unwavering commitment
to combat the global COVID-19 pandemic,
Takano transitioned to a gene analysis company
in 2020, where the company is trying to provide
quick PCR testing services all over the Japan.
In his short-term tenure as CFO, he engaged
in reorganizing company back office function
including series of logistics management

CXO MAGAZINE, APRIL 2024

and royalties, cementing Heartseed's position as afrontrunner in the biotechnology landscape.

system starting from distribution of PCR testing
kit through testing result provision, thereby
contributing to public health initiatives keeping
economic activities alive even in a part by theperson non infected, while the nationwide fearto the infection tends to claim for stopping
everything and staying home.
August 2020 heralded a new chapter in
Takano's illustrious career as he assumed
the mantle of CFO and Director of the Board
at Heartseed Inc. Here, Takano's visionary
leadership and financial prowess have been
instrumental in steering the company toward

CXO MAGAZINE, APRIL 2024

prosperity. Leveraging his extensive expertise,
he established the Strategic Finance and Investor
Relations Department, a pivotal move that has
fortified Heartseed's financial framework. On theother side in business partnership development
and negotiation with Novo Nordisk, he served
the Heartseed special team from the perspectivesof risk management. Under Takano's stewardshipand agile leadership, Heartseed has secured
substantial capital investments, totaling JPY6billion, and clinched a transformative global
licensing agreement with Novo Nordisk,
poised to unlock unprecedented milestones

Under Takano'sstewardship,
Heartseed hassecured substantial
capital investments,
totaling JPY6 billion,
and clinched atransformative global
licensing agreementwith Novo Nordisk,
poised to unlock
unprecedented
milestones androyalties, cementing
Heartseed's position
as a frontrunner inthe biotechnology
landscapeA Journey of Hope and Innovation
In his early years, Mutsuki Takano witnessed
firsthand the impact of severe asthma on his
mother's life. Despite the challenges, she managed
her role at a software engineering company, often
needing emergency medical attention duringasthma attacks. Yet, with access to medication anda supportive healthcare system, she persevered,retiring after a successful career. This experience
ignited Takano's belief in the power of medication
to empower individuals facing serious illnesses,
enabling them to pursue their aspirations.
As Takano reflects on his tenure overseeing
operations at Mitsui's Venture Capital divisionin the US, he recalls encountering numerous
biotechnology companies addressing unmet
medical needs on a global scale. "I saw mainly
US companies, sometimes EU or Israel or China,
but not so much about Japan companies," Takano
remarks. However, Takano's journey took atransformative turn upon joining Heartseed in2020. "Our CEO, Dr. Fukuda, showed me a videoof living, beating cardiomyocytes[1] derived
from induced pluripotent stem cells[2]. It was thefirst time I had seen such synchronicity among
cardiomyocytes, sparking immense excitement
within me," Takano shares.
At Heartseed, their corporate mission of"Opening the door to the treatment of heart disease
through regenerative medicine" drives theirinnovation. Guided by core values collectivelytermed as "Heartseed Value," the company fosters aculture of pioneering spirit, self-driven innovation,prioritization of life, continuous growth, andcollaborative teamwork.

CXO MAGAZINE, APRIL 2024Navigating the Frontier of Cell Therapy
In the realm of cell therapy, there exist two
distinct approaches to treatment, differing intheir intended duration of cell presence within
the patient's body. Takano explains, "Thefirst, exemplified by mesenchymal stem cells,
involves the infusion of cells that naturally
dissipate within a short timeframe, thus
requiring lower safety standards and no need for
immune suppressants."
In contrast, the second approach, epitomized
by Heartseed, aims to prolong the presence ofcells within the patient's body significantly,
necessitating stringent safety measures.
Heartseed's commitment to safety is underscoredby requirements such as demonstrating one
year of tumorigenicity[3] in animal models
following cell infusion, in addition to conducting
comprehensive long-term toxicity studies.
"The intricacies of the second type of celltherapy demand advanced cell technology toGuided by corevalues collectivelytermed as "HeartseedValue," the company
fosters a culture ofpioneering spirit, selfdriven innovation,prioritization of life,
continuous growth, andcollaborative teamworkCXO MAGAZINE, APRIL 2024

ensure both safety and stable manufacturing
processes," Takano emphasizes. Heartseed’s
focus lies in producing ventricular-specificcardiomyocytes exclusively, mitigating the riskof arrhythmias that may arise from contamination
with arterial or pacemaker cells.
Takano elaborates, "We have achieved aremarkable purity of 99+% in our cardiomyocyte
production, thanks to our innovative metabolic
selection process." This process, developed
to eliminate non-cardiomyocyte cells, relieson the differential metabolic requirements ofcardiomyocytes versus other cell types. "By
implementing this strategy," Takano explains,"we can ensure the safety and efficacy of our final
product, even at scale, facilitating our entry into
global markets."
Highlighting Heartseed's lineage, Takano
praises CEO Dr. Fukuda's groundbreaking
research. "Dr. Fukuda, an esteemed emeritus
professor at Keio University, boasts a
distinguished career in this field," Dr. Fukuda'spioneering work, including the successful
differentiation of bone marrow mesenchymal
stem cells[4] into cardiomyocytes in 1999, laid
the foundation for Heartseed's inception in 2015.
Leveraging over two decades of research andclinical experience, Heartseed emerged from
Keio University with unparalleled expertise and awealth of cell-treating innovations.
Revolutionizing Heart Failure Treatment
The unique characteristics of cardiomyocytes
beating within the left ventricle of the humanheart distinguish them from other cell types.
Unlike cells in tissues such as hair and skin,cardiomyocytes lack self-proliferation capability,
rendering the heart vulnerable to irreversible
damage in conditions such as heart failure.

CXO MAGAZINE, APRIL 2024

"At any instance of heart damage, such as
myocardial infarction, cardiomyocytes perish,
leading to a gradual decline in heart function,"
Takano explains. "Despite advancements inguideline medications, such as the 'Fantastic
4'—comprising β-blockers, ACEIs/ARNIs,
MRAs, and SGLT2is—that can improve heart
performance, there remains a therapeutic plateau
after maximum dosage administration."
Takano underscores the limited options for endstage heart failure patients, noting, "While hearttransplants offer a potential solution, the numberof eligible patients is restricted. Alternatively,
Left Ventricle Assist Devices (LVADs) providemechanical support, but they come with significant
burdens and risks, including the need for caregiverassistance in case of device malfunction."
Highlighting the substantial unmet medical
needs in severe heart failure, Takano emphasizes,"The progressive decline in living cardiomyocytes
directly correlates with diminishing heart
function." Heartseed envisions a solution tosevere heart failure through 'remuscularization'—
the replacement of dead cardiomyocytes withliving counterparts. Takano shares, "Our ongoing
Phase 1/2 clinical trial for heart failure with
reduced ejection fraction (HFrEF) involves
the use of spheroids of allogeneic iPS-derived
cardiomyocytes. Initial trial results have shownpromising signs of cell engraftment and heart
function recovery in patients within one yearof treatment."
The Synergy of Finance and Innovation"The intersection of financial management andlife-saving treatments is pivotal," asserts Takano.
Success in financing activities directly impacts
the advancement of clinical trials and researchand development efforts. In times of budgetary

CXO MAGAZINE, APRIL 2024

constraints, prioritizing key pipelines becomes
imperative, aligning with industry norms.
Takano reflects on the multifaceted role ofa CFO in a biotech company. "Beyond a deep
passion for improving patient outcomes, CFOs
must possess a diverse skill set akin to that of amixed martial artist," he observes. "Navigating
investor demands, fluctuating market conditions,and unforeseen emergencies requires agility,resilience, and strategic acumen. Merely
possessing technical knowledge is insufficient;past experiences in adversity and a robust spirit
are equally vital."
In the realm of HFrEF treatment throughRemuscularization therapy, Heartseed stands
at the forefront of global competition.
Takano proudly states. "With partnershipand empowerment by Novo Nordisk forglobal development, we expect Heartesed
Remuscularization therapy would provide
transformative solutions to heart failure
patients worldwide in future. "Takano recounts his achievements infinancial leadership, highlighting successful
equity financing rounds totaling approximately

JPY6 billion and instrumental involvementin the global licensing deal with NovoNordisk. "While milestones bring temporary
satisfaction, the pursuit of growth andinnovation remains perpetual," he remarks. "Asa biotech company, our focus lies in delivering
Remuscularization therapy to heart failure
patients, driving towards a future of improved
healthcare outcomes.""With the recent release of one-year initial
data from our LAPiS study for advanced heart
failure patients, excitement abounds," Takanoshares. "We eagerly anticipate the future
progress of our clinical trials, poised to bringhope and healing to those in need."
Forging Bonds
In the dynamic landscape of the biotech industry,collaboration among individuals with diverse
backgrounds and perspectives is paramount.
Takano asserts, "To harness collective efforts
effectively, fostering mutual trust emerges asa cornerstone."
Takano reflects on the invaluable lesson
imparted by a former mentor during his tenure atHeartseed envisions a solution to severe heart
failure through 'remuscularization'—the replacementof dead cardiomyocytes with living counterparts

CXO MAGAZINE, APRIL 2024

spheroids (micro tissues) of iPS derived cardiomyocytes

Mitsui & Co.'s Private Equity Division. "Building
trust entails three fundamental principles,"Takano recalls. "Responsiveness, ensuring timely
and accurate responses to the needs of others;
Speed, delivering prompt responses alignedwith expectations; and Commitment, steadfastly
upholding promises made towards realization."
He emphasizes the application of theseprinciples beyond business transactions,particularly in processes such as Due Diligence.
"While Due Diligence may seem cumbersome attimes, adhering to these principles transforms
it into a mutual trust-building exercise,"Takano explains. "Consistent application ofthese principles fosters enduring relationships
and facilitates smoother interactions withstakeholders."
Drawing inspiration from his mother's journeyof balancing career and family responsibilities,
Takano underscores the significance of medicalinnovation. "As a parent myself, I recognize
the profound impact of advancing medical
treatments on the lives of loved ones," Takanoconcludes. "I am humbled to contribute, albeit
in a small capacity, to the ongoing pursuit ofmedical innovation."[1] Cells in the heart responsible for contractions, playing a crucial role in cell therapy forheart disease. Regenerating or replacing cardiomyocytes offers new possibilities for treatingheart conditions like heart failure.
[2] Cells created from adult cells that have been reprogrammed to behave like embryonicstem cells. They can become any type of cell in the body, offering great potential forregenerative medicine and disease modeling.
[3] The ability of a cell population transplanted into an animal to give rise to malignant or
benign tumors by proliferation, one of the concerns for stem cell therapies.
[4] A type of stem cell found in various parts of the body, like bone marrow and fat.
They're known for their ability to develop into different types of tissues, including bone,cartilage, muscle, and nerve tissues. MSCs were widely studied for their potential in cardiac
regenerative medicine, but there are no products approved for heart diseases by FDA.

CXO MAGAZINE, APRIL 2024