Kiadis Pharma N : Corporate Presentation September 2020

K I A D I S P H A R M A | CO M PA N Y P R ES E N TAT I O N | S E P T E M B E R 2 0 2 0

EURONEXT: KDS

Leveraging the natural strengths of humanity and our collective immune systems to source the best cells for life

K-NK-cell therapy to treat cancer and infectious disease

K-NK-cells:enoughof the rightNK cells, broad opportunity in cancer and infectious disease

Unique proprietary immunotherapy platform, with broad applicability:

• Hyper-functionalNK-cell phenotype, all killing mechanisms
• Engineering optional and synergistic, but not required
• Optimal donors with disease specific attributes

Off the shelf, industrial, scalable

• Industrial, robust, tumor-free manufacturing
• Millions of doses, cryopreserved, cost of goods competitive to antibody

Clinical proof-of-concept in 45 immunocompromised blood cancer patients

• Remarkable remissions; Improvement in relapse and survival
• Anti-infectiveefficacy (viral/fungal/bacterial)
• No safety event (no CRS, no GVHD, no serious AE)
• Repeat dosing, persistence and proliferation in patients

KIADIS PHARMA | www.kiadis.com | CONFIDENTIAL

2

K-NK cells: Sourced from optimal Universal Donors, manufactured with PM21, supplied off-the-shelf

1. Source panels of optimal Universal Donors

• Mature fully licensed NK cells as starting point
• Universal Donor, suitable for all patients, with disease specific attributes

2. Produce millions of doses of hyperfunctional K-NK cells using PM21

• Activation and expansion of Universal Donor NK cells with PM21 (membrane particles of FC21 mbIL21)

• Epigenetics and engineering to enhance product specific efficacy (knock outs, CARs)
• Cryopreservation and storage

3. Supply off-the-shelf supply, immediately available as needed for patients

KIADIS PHARMA | www.kiadis.com

3

Broad applicability: hyper-functional, role across diseases

Natural NK cells: Role

against cancer and infectious disease

Hyper-functionalK-NK cells:

• PM21: all killing

Synergy with antibodies:

Killing upon binding of disease specific antibodies via CD16 (ADCC)

		Activation of adaptive
		immune system:
Antibody	IFNγ	Secretion of cytokines,
CD16		including IFNγ

NK-cell

	mechanisms
	upregulated
•	Universal donor:
	optimal profile and
	minimal inhibition

KIRXDSX

Direct killing via multiple targets: 20+ receptors against stress and viral ligands (many indications, heterogeneous disease, escape)

Activating receptor

Inhibitory receptor

KIADIS PHARMA | www.kiadis.com

No inhibition upon recognition of HLA 'self':

Donor-patient mismatch improves outcomes, no GVHD or safety risk

4

Scalability and off the shelf supply: potential for 1 million doses from each donor

Each donor		Initial K-NK			K-NK expansion		1 million doses
	expansion for			for patient
		intermediate	High density		supply		K-NK Final
			intermediate				inventory
		50 billion cells	bank;		20 trillion cells
		per 2 week run	Adequate for 50		per 3 week run
	(50 doses per run)	runs	(20,000 doses per run)

Dosing: 1 billion cells/dose

KIADIS PHARMA | www.kiadis.com

5

Pipeline: clinical proof-of-concept, cancer and infectious disease

PRE-

CLINICAL

CLINICAL

PROGRAM

INDICATION

SETTING

PRODUCT

CLINICAL

PoC

PH. 1

PH. 2

STATUS

K-NK002

HSCT in

Adjunctive to

Haplo

Phase 2 with US BMT-

blood cancer

SoC (PTCy)

24 patients

CTN; IND approved

K-NK003

AML R/R

After induction

OTS

Phase 1 with US OSU;

(>3L salvage)

chemo (FLAG)

21 patients

enrolling patients

K-NK004

Multiple

Combination

OTS

Upfront €17,5M;

myeloma

with Sarclisa

CD38KO

value >€875 million

K-NK-ID101

Influenza /

Prophylaxis &

OTS-ID

IND approved; funded

COVID-19

treatment

by ARMI/US DoD

Undisclosed

Cancers and

Stand alone or

Proof-of-concept

infections

combo's

cancer study in 2020

KIADIS PHARMA | www.kiadis.com

6

K-NK004 partnered to Sanofi - potential deal value >€875 million

• K-NK004targets €15 billion market in multiple myeloma
• • Anti-CD38antibodies hamper their own efficacy by depleting patients' own NK cells (no ADCC available)
  • In K-NK004 cells CD38 has been knocked out, thus K-NK004 can not be depleted
  • Sanofi to combine K-NK004 with Sarclisa®, Sanofi's recently approved anti-CD38 antibody
• Sanofi gains exclusive worldwide rights to K-NK004
• • K-NK004in combination with anti-CD38 antibodies in multiple myeloma and CD38+ blood cancers
  • Two additional pre-clinical programs
• Potential deal value ~€875 million, plus royalties
• • €17.5 million upfront
  • €857.5 million in preclinical, clinical, regulatory and commercial milestones
  • Up to low double-digit royalties on Sales by Sanofi

KIADIS PHARMA | www.kiadis.com

7

K-NK unlimited opportunities

Separate products, based on disease specific:

• Universal donor profile
• K-NKattributes
• Engineering (optional)

• AML R/R (induction and maintenance)
• Multiple myeloma (with Sarclisa)
• CML (refractory to TKI)
• …

			Blood
			cancers
• HNC and CRC (with Erbitux)	Solid		Infectious
•	Ovarian Cancer (with PARPi)	K-NK
tumors	disease
•	…

Transplants

• Haplo HSCT

• Matched donor HSCT (OTS)

• …

KIADIS PHARMA | www.kiadis.com | CONFIDENTIAL

• Influenza/COVID-19
• Microbial hospital infections
• …

8

K-NK: differentiated versus other platforms

	COMPANY	CLINICAL	STAGE	SOURCE	REGU-	ENGI-	PARTNER	POTENCY &	SCALE UP &
	POC	LATORY	NEERNG	BREADTH	REGULATORY
	Nantkwest	✓	Phase 2	Cell line	Cancer cell	Required
	Fate		Phase 1	iPSC	Cancer cell	Required	J&J
	Takeda	✓	Phase 1/2a	Cord blood	Cancer cell	Required	Takeda
	Nkarta		Preclinical	Donor	Cancer cell	Required
	Kiadis	✓✓	Phase 2	Universal	PM21	Optional &	Sanofi
	donor	synergistic	US DoD

KIADIS PHARMA | www.kiadis.com | CONFIDENTIAL

9

The future of immunotherapy: enoughof the rightNK cells

Dr. Carl June

Kiadis SAB member

"NK-cell therapy could significantly advance immuno-oncology."ASCO 2018

			Others	K-NK
	Functionality	Potent and persistent, repeat	✓	✓✓
	dosing
	Breadth	Effective across indications,	✓	✓✓
	heterogeneous disease/escape
	Manufacturing	Industrial/scalable and off-the-	✓	✓✓
	shelf
	Regulatory	Safety profile suitable for mass		✓✓
	usage
KIADIS PHARMA | www.kiadis.com			10

K-NK002

Adjunctive to standard of care haploidentical hematopoietic stem cell transplantation (HSCT) with post transplant cyclophosphamide (PTCy)

K-NK002: improvement in Survival, Relapse and GVHD in haplo HSCT

30 billion K-NK cells during HSCT (10 times healthy recipient levels):

• Residual tumor cells sensitized to NK cell killing by chemo
• Patient's own NK cells killed by chemo

	Haplo HSCT	Haplo HSCT
	matched control
READ OUT AT 2 YEARS	with K-NK002	Relapse
(US CIBMTR;
	(MDACC; n=24)
	n=160)
				Control: 38%
Relapse	4%	38%
	(30-46%)
Relapse Free Survival	66%	44%
Non-Relapse-Mortality	30%	18%			K-NK002: 4%
		(0-16%)
Overall Survival	70%	58%
Chronic GVHD	0%	44%

• Phase 1/2: Investigator trial at MDACC: AML/MDS/CML; patients in CR; 59% high risk cytogenetics, median follow up 44 months (range 15-61); dose escalation 13 pts at 105 to 108 cells/kg per dose; highest dose 11 pts at 108 cells/kg per dose
• Control: Matched control from US CIBMTR database (up to 1:4 per patient), matched for e.g., age, disease type/status

KIADIS PHARMA | www.kiadis.com

Ciurea et. al. Blood 2017; Ciurea EBMT2018; Ciurea Haplo2018; Ciurea ASH2019 12

12

K-NK002: Phase 2 NK-REALM in haplo HSCT - IND approved

Haploidentical donor

Single arm, open label, multicenter trial:

• 63 AML/MDS patients
• Adjunctive to haploidentical HSCT with PTCy
• Three doses of 108 NK cells/kg
• Safety lead in 6 patients (107 NK and 108 NK cells/kg)
• Primary endpoint: 1-year relapse
• Statistic plan: reduction from 30% (CIBMTR control) to 15% (K-NK002)
• Haplo donor; PM21 (bridging from FC21 accepted by FDA)
• With US Blood and Marrow Transplant Clinical Trials Network (BMT-CTN)

Peripheral blood collection no	Marrow collection on
later than day -35	day 0
NK cell	Marrow
expansion	infusion
Hydration
-8-7-6-5-4-3-2-1 0	1	2	3 4	5	6	7 8	9	28
Marrow Collection/Infusion							Tacro/MMF beginning day 5
Melphalan 140 mg/m2			GCSF beginning day 7
K-NK002	Melphalan 100 mg/m2	(Age 60 or older)
	Fludarabine 40 mg/m2
TBI 2 Gy	Cyclophosphamide 50 mg/kg

KIADIS PHARMA | www.kiadis.com

13

K-NK002: addressing significant unmet need, with small commercial footprint

HSCT unmet need:

relapse, GVHD, survival

Haplo

Matched Unrelated Donor (MUD)

	53%	51%49%
		45%
38%		38%
26%	27%

Acute	Chronic	Relapse Survival
GVHD II-IV	GVHD

Large patient population:	Top 25 centers perform 65%
>25,000 HSCTs per year	of HSCT procedures
US/EU	2019	2024	CAGR
Thousand
Total	24,2	25,7	1,2%
Cord Blood	1,2	1,0	-4.0%
MUD	11,0	9,9	-2.1%
MRD	6,6	6,7	0.2%
Haplo	5,4	8,2	8.5%
				All Centers	Top 25 Centers*

'Relapse is the major unmet need' Elmariah and Fuchs 2019; Robinson et al 2016

KIADIS PHARMA | www.kiadis.com | CONFIDENTIAL

Size of dot corresponds to total HSCT procedures

Overlap between top 25 sites and NK REALM sites

Simon-Kucher & Partners 2018, CIBMTR transplant data, 2014. Fuchs 207 (up to 3 years follow up; Weighted average of 5 PTCy/MUD comparison publications (n=463 PTCy and n=2647 MUD)

14

K-NK003

Acute Myeloid Leukemia R/R: >3L salvage patients

K-NK003: Remarkable remissions in severe AML R/R >3L salvage patients

Single course after induction chemo (1-8 Billion K-NK cells)

SITES	PATIENTS	REMISSION	OTHER
MDACC	• 4-5 median prior treatments	CR/CRi: 75% (6pts)	•	Subsequent HSCT:
(8 pts)	• 12 out of 21 patients relapsed			43% (9 pts)
	after prior HSCT	ORR: 78,5%	•	With ORR: median
	• 40% median BM blasts		OS 344 days (HCPA)
HCPA	(11 pts)
• Most refractory to FLAG	•	With CR/CRi: median
Brazil	of which
• Many with CNS disease and		DFS 199 days (HCPA)
(13 pts)	CR: 50% (6 pts)
infections, e.g., fungal, TB
	CRi: 7% (1 pt)

Literature FLAG in >3L salvage population: CR: ~20%

Phase 1 Investigator trials: 6 doses in 11 day window at 106 and 107 cells/kg per dose of K-NK-cells from haplo donor; Produced with FC21

Ciurea SO et. al. ASCO2018; Ciurea SO Haplo2018; Silla L et al ASCO 2020; Silla L et al EHA 2020; Silla L et al EBMT 2020

NCCN guidelines; Roboz GJ, et al. JCO.2014; Jabbour E, et al. Clin Lymphoma Myeloma.2012; Ravandi et al, Blood 2010; Velluchamy 2017: 6 studies, Romee et al. 2016; Shaffer et al. 2016; Rubnitz et al. 2015; Bachanova et al. 2014; Curti et al. 2011; Miller et al. 2005; AML patients only

KIADIS PHARMA | www.kiadis.com

16

16

K-NK003: Remarkable remissions in severe AML R/R >3L salvage patients (Brazil)

• Resolution of CNS and infections

• Inflammation at site of disease

• K-NK cells present in cerebrospinal fluid

• No dose-limiting toxicities; No cytokine storm syndrome

• All patients refractory to prior FLAG therapy

Source: Silla L et al, EHA 2020; Silla et al, ASCO 2020, abstract #3025; Silla L et al, EBMT 2020

KIADIS PHARMA | www.kiadis.com

17

K-NK003: Remarkable remissions in severe AML R/R patients with CNS disease and infections (Brazil)

		Patient 1: Female 48	Patient 3: Female 48	Patient 4: Male, 31	Patient 5: Male, 22
	CNS disease	Mycetoma (aspergillus)		Bone and nerve root	Uncus/ brain stem
	Infections	VRE (enterococcus);	Pulmonary tuberculosis
		Pulmonary aspergillus
	Prior treatments	6 (including HSCT)	6 (including 2 HSCTs)	4 (including HSCT)	7 (including HSCT)
	Relapse	4th relapse	3rd relapse	2nd relapse	3rd relapse
	Total KNK cells	1,4 B cells (106 cells/kg)	2,5 B cells (6.9 × 106)	2,9 B cells (5.5 × 106)	3,3 B cells (8.3 × 106)
	infused
	Complete Response	CR	CR	CR(i)	CR
		Mycetoma resolved	TB resolved
	Duration CR	151 days	301 days	31 days	168 days
	Overall Survival	344 days (no HSCT)	440 days (no HSCT)	176 days (no HSCT)	505 days (no HSCT)

Source: Silla L et al, EHA 2020; Silla et al, ASCO 2020, abstract #3025; Silla L et al, EBMT 2020

KIADIS PHARMA | www.kiadis.com

18

K-NK003: Remarkable remissions in severe AML R/R

patients

Male, 22 years (HCPA; Brazil)

• 7 lines of prior treatment, incl prior failed HSCT
• 2nd CNS relapse, refractory to therapy
• CR; Duration of response 168 days, no subsequent HSCT, overall survival 505 days

Male, 25 years (MDACC)

• 8 lines of prior treatment, incl prior failed HSCT
• Active disease, 90% BM blasts
• CR; Reduction of MRD during 4 months; No subsequent HSCT, overall survival 2 years

Pre-treatment:	1 week after K-NK:	6 months after:
CNS disease	Inflammation	Disease free

Minimum residual disease (% BM blasts)

K-NK003

CR

Continued MRD

reduction

Days

Silla L et al EBMT 2020

KIADIS PHARMA | www.kiadis.com

Courtesy S. Ciurea, MDACC

19

19

K-NK003: Phase 1 in AML R/R (with Ohio State University) - enrolling

Kiadis supported, single arm, open label, investigator-initiated trial

• Primary refractory AML, relapsed AML (>3L salvage)
• Ages: 18 to 80 yrs
• Objective: Establish safety for induction of remission
• Endpoints: Recommended phase 2 dose; Overall Response Rate
• Single course (6 doses within 11 days after induction chemo)
• Dose escalation: 1 x 107 and 3 x 107
• FC21 (switching over to PM21)
• Retreatment/maintenance (if no subsequent transplant)
• Universal Donor; Off the shelf

Potential for further improved outcomes versus current data:

• No waiting time before treatment of patient
• Superior Universal donor
• Retreatment/maintenance
• Higher dose level

KIADIS PHARMA | www.kiadis.com

20

K-NK-ID101:

Universal platform for Respiratory/COVID-19 Seasonal and pandemic

K-NK cells in infectious disease: clinical data in severely immuno-suppressed patients

Immuno-suppressed HSCT patients (K-NK002):		Immuno-compromised patients (K-NK003):
anti-viral				anti-microbial
			• Patient 1: pulmonary and
Control				CNS fungal infection resolved
				(aspergillosis)
K-NK002	Control		•
		Patient 3: pulmonary
	K-NK002
			tuberculosis resolved
			•	Patient 11: ascending
				cholangitis resolved (E.coli)

Literature haplo HSCT: 63% CMV reactivation and 30% BKV infections

Ciurea et. al. Blood 2017; ASCO 2020, L. Silla abstract #3025;

CMV (482 out of 766 patients) and BKV (151 out of 504 patients): Ramlal 2016; Mohty 2019; Malki 2018; Crochiollo 2015; Goldsmth 2016; Slade 2017; Gaballa 2016; Solomon 2015; Raiola 2012; Luznik 2008

KIADIS PHARMA | www.kiadis.com | CONFIDENTIAL

22

K-NK-ID101: address unmet need for influenza & COVID-19

Need:

Prophylaxis/treatment for all seasonal/pandemic strains for influenza and COVID-19

Unmet need with current products:

• Specificity (separate for each virus/strain)
• Time (especially in pandemic)
• Immunocompromised/high risk patients (product efficacy)

K-NK-ID101:

Universal pre-/post-exposure prophylaxis and treatment:

Effective across all influenza/SARS strains

Immunocompromised/high-risk patients, healthcare

workers and military:

Hospital/outpatient setting

Seasonal and early pandemic response:

Off the shelf; Scalable; Health economic benefit

KIADIS PHARMA | www.kiadis.com | CONFIDENTIAL

23

Influenza - NK cells effective across strains, lymphopenia associated with severity of disease

	Effective against across strains	NK-cell lymphopenia associated with	NK-cell inhibition associated with
	(example H3N2)		severe disease (H1N1 2009)	severe disease (H1N1 2009)
		Uninfected			% NK-cell
		A/Eng/878/1969			Mild	Severe
				Lymphopenia
		A/Eng/327/1990
		A/Eng/919/1999
					3%	67%
		A/Eng/24/2000			At enrolment
					(1/39)	(6/9)
					While	13%	100%
					admitted	(5/39)	(10/10)
					After	5%	12%
					recovery	(1/19)	(1/8)

'NK cells play a vital role in the early control of influenza virus replication.' 'Lung tissues from infants with fatal influenza demonstrate a near absence of CD8 T cells and NK cells such that severity has been attributed to inadequate rather than excessive immune responses'

KIADIS PHARMA | www.kiadis.com | CONFIDENTIAL	Owen et al, J. Virol. 2007; Aranda et al, 2012; La et al, PLOS 2011; Fox et al, PLOS 2012	24

COVID-19 - NK cell lymphopenia associated with severity of disease

Severe patients have fewer	NK cells in severe patients	Lower proportion of NK cells
NK cells	make less IFNy	correlates with longer disease

Duration of illness

Recovered patients: number of NK cells is restored and number of cells expressing NKG2A

(marker of immature or exhausted cells) is reduced

Apoil PA 2017; Zhang 2020; Chen 2020; Liu 2020; Zheng 2020

KIADIS PHARMA | www.kiadis.com | CONFIDENTIAL

25

K-NK-ID101: Enhanced antiviral potency

Stronger cytotoxicity	Upregulated anti-viral receptors
	K-NK cells

Normal blood NK-cells

Similar for NKp46 and CD16

Denman et al., PLoSONE, 7(1), 2012

Increased cytokine secretion

	10000
[pg/ml]	1000
Supernatant	10
	100
	1	mbIL15	mbIL21		mbIL15	mbIL21
	Fresh	Fresh
		IFNg			IL-2

KIADIS PHARMA | www.kiadis.com

26

K-NK-ID101: collaborations COVID-19

Research with Dutch consortium:

• Mode of Action
• Function vs Phenotype
• Interplay with antiviral antibodies (mAb & vaccines)
• In vitro & in vivo influenza and CoV infection models

Phase 1/2 with NCH (En-Cor;IND approved; 30 patients)

Research

Phase 1/2a trial

										Marketing
										authorization
							Phase 3 trials
									Large-scale supply
							GMP large
				Emergency use					contract US
						scale
				authorization					government
	Phase 2b trials					capacity (>
			Initial supply
	GMP capacity					million doses
			contract US
					p.a.)
	expansion			government

ARMI/DoD funded $9,5M	Future funding
KIADIS PHARMA | www.kiadis.com | CONFIDENTIAL	27

K-NK-ID101: attractive seasonal and pandemic opportunity

Immunocompromised/high risk patients (US target population: >>>10 million):

• Immunosuppressed: Transplants, Cancer, RA, Crohn, MS, COPD, Asthma
• Immuno-compromised:SCID, PID, sickle cell anemia
• Co-morbidities:Heart disease, stroke, HIV/AIDS, CKD, CF, liver disease
• Critical and intensive care patients
• Neonates
• Pregnant woman
• Nursing home residents

Pandemic response (US target population: >10 million):

• Healthcare workers (8 million in US)
• Law enforcement/firefighters (2 million in US)
• Military (2,3 million in US)

9/30/2020 KIADIS PHARMA|CONFIDENTIAL		28

Corporate

The transformation of Kiadis in 2020

1H 2019

Acquired CytoSen Therapeutics and NK-cell platform

Phase 3 and preparation potential commercial launch of ATIR

Restructured business; focusing on K-NK programs

Formed NK-cell scientific advisory board

Terminated ATIR

2H 2019

Efficacy and persistence data in 45 patients and K-NK platform data at major medical meetings (ASGCT, ASCO, EHA)

IND approved for K-NK002 phase 2 study (NK-REALM; 63 patients)

First patient enrolled and treated for K-NK003 Phase 1 in R/R AML

2020 YTD

Partnered new K-NK004 program to Sanofi; potential deal value of

>€875 million

Launched infectious disease; IND approved for K-NK-ID101 in COVID-19 trial; $9.5 million US government grant received

KIADIS PHARMA | www.kiadis.com

30

Kiadis: strong leadership team with unique cell therapy experience & renowned scientific advisory board

MANAGEMENT TEAM

SCIENTIFIC ADVISORY BOARD

ARTHUR LAHR, CEO

ROBERT FRIESEN, CSO

ANDREW SANDLER, CMO

DIRK DE NAEYER, COO

AMY SULLIVAN, CStratO

RAY BARLOW, CBO

CARL JUNE, MD

CHIARA BONINI, MD

DEAN LEE, MD, PhD, Chairman

ELAINE MARDIS, PhD

HELEN HESLOP, MD, DSc

KRISHNA KOMANDURI, MD

MICHAEL CALIGIURI, MD

TODD FEHNIGER, MD, PhD

KIADIS PHARMA | www.kiadis.com

31

Kiadis: significant progress in 2020 sets the stage for a promising 2021

			2020	2021
			✓ IND filing and approval for NK-REALM study	• Completion safety lead-in and start open enrolment
	K-NK002			NK-REALM Phase 2 trial
		✓ Updates existing clinical proof-of-concept trials
	HSCT		• Interim efficacy and persistence data NK-REALM
		• Start NK-REALM Phase 2 trial enrolment
				Phase 2 trial
	K-NK003		✓ IND approval for Phase 1 trial
		✓ Start Phase 1 trial enrolment	• Interim efficacy/safety data Phase 1 trial
	AML R/R
		✓ Updates existing clinical proof-of-concept trials
	K-NK-ID101		✓ Establish and execute R&D collaborations	• Start Phase 1/2 enrolment
	Influenza /		✓ Government grants	• Interim read out Phase 1/2 trial
	COVID-19		✓ IND approval Phase 1/2 trial	•	Additional government grants
			✓ Preclinical data	• Interim clinical data proof of concept
			✓ Pharma/biotech BD partnership
	Other		•	Pharma/biotech BD partnership
		• Start clinical proof-of-concept (signal) trials in
			• Start new clinical studies
			solid/blood tumors
	KIADIS PHARMA | www.kiadis.com		32

Risks associated with our business

The following are a selection the key risks that relate to our industry and business, operations and financial condition, and to our shares. For further information on the risks that we are subject to, reference is made to the risk factors included in our financial statements and any prospectus that we may publish from time to time.

• We are dependent on external funding in the foreseeable future and require substantial additional funding to continue our operations, including during the next twelve months. If we are unable to raise funding when needed or on acceptable terms, we could be forced to delay, reduce or terminate our development programs and may be unable to continue as a going concern and ultimately go into insolvency.
• We have a history of operating losses and will continue to incur operating losses for the foreseeable future. We may never achieve profitability, while our net losses are expected to fluctuate significantly.
• We are early in our development efforts and all of our programs are in early stage clinical development or preclinical development. If we are unable to advance our programs through clinical development, obtain regulatory approval and commercialize one or more of our product candidates, we may never generate any product revenue and our business will be materially adversely affected.
• Our NK-cell platform and the technologies we are using are new and unproven. The use of NK-cells expressed with PM21 particles and the use of universal donors for NK-cells is a novel and unproven therapeutic approach without any clinical studies in humans with NK-cells produced with our NK-platform having been performed yet, and our development of our NK-platform and our NK-programs may never lead to a marketable product.
• In relation to our lead program K-NK002 and K-NK003,investigator-initiatedproof-of-concept studies have been performed, which may affect the reliability of the results and data generated in these studies and the extent that these are of use for the further development of these programs.
• We may experience setbacks in our clinical trials, including delays in commencing, conducting or completing, inability to commence, conduct or complete, or inconclusive or negative results, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects.
• Due to our limited resources and access to capital, we must prioritize development of certain programs and our decision to pursue these programs may prove to be unsuccessful as they may never receive regulatory approval or achieve profitability.
• We currently rely on a single contract manufacturing organization to provide supplies of our product candidates for our planned clinical trials. We expect to increase manufacturing capacity by using existing or other CMOs and potentially in the future developing our own manufacturing facilities for clinical trials and commercial production of our products. We have no experience operating a manufacturing facility, and we may not be successful in developing our own manufacturing facilities or capacity in the future if we chose this route. If we cannot manufacture our product candidates in sufficient amounts, with CMOs or ourselves, at acceptable costs and on a timely basis, we may be unable to supply sufficient products for clinical trials or to support commercialization.
• In order to have sufficient NK-cells for our planned clinical trials we need to improve and scale up our NK-cell manufacturing process. This could require the process or parts thereof to be changed, which may require revalidation, additional comparability or bridging clinical trials and regulatory vetting and we may experience setbacks in our trials if we do not succeed in improving and upscaling this process or experience delays.
• We rely on third parties who license intellectual property rights to us, including intellectual property relating to our NK-platform. If any such license is terminated, we may be unable to commercialize and market our products candidates.
• The price of our shares may be volatile and fluctuate significantly.
• Ownership of our shares is highly concentrated and the interests of our significant shareholders may conflict with the interests of our other shareholders.
• Future sales and issuances, or the possibility of future sales or issuances, of a substantial number of shares could significantly lower the price of our shares and dilute the interests of shareholders.
• There may be limited liquidity of our shares, which may affect the price of the shares and make it difficult for investors to sell shares at or above the price paid for them or at all.
• We may implement anti-takeover protection that may prevent a change of control, and Dutch corporate law contains provisions that may delay or discourage a takeover attempt.

KIADIS PHARMA | www.kiadis.com

33

When it comes to life-threatening diseases, we are one family.

Kiadis is leveraging the natural strengths of humanity and our collective immune systems to source the best cells for life.

Our uncompromising approach to serve patients, their families and care givers aims to minimize harm and maximize help - delivering personalized treatments for every single patient to offer hope, reduce suffering and provide new life.