Corporate Presentation
November 2023
Forward-Looking Statements
This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our management's beliefs and assumptions and on information currently available to our management. All statements other than statements of historical facts contained in this presentation, including statements regarding the potential benefits, value, synergies and results that may be achieved through our collaboration with Kite; the anticipated payments that may be received by us in connection with the collaboration, including potential milestones and royalties; our and Kite's respective rights and obligations under the transaction agreements; expectations of our ability to benefit from Kite's capabilities, including operational, manufacturing and commercialization expertise and infrastructure; expected costs and expenses to be incurred and shared with Kite; our future financial condition and runway, results of operations, business strategy, milestones, team and operations, timelines, and prospects; the potential of and expectations regarding our product candidates, programs, platform and technology; the mission, plans and objectives of management and; industry trends, including changes in market opportunity, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "can," "contemplate," "continue," "could," "design," "estimate," "expect," "future," "goal," "imagine," "intend," "likely," "may," "mission," "might," "objective," "ongoing," "plan," "potential," "predict," "project," "should," "target," "united to," "will," or "would," or the negative of these terms or other similar expressions or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs, and these statements represent our views as of the date of this presentation. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Information regarding certain risks, uncertainties and assumptions may be found in our filings with the Securities and Exchange Commission. New risk factors emerge from time to time and it is not possible for our management team to predict all risk factors or assess the impact of all factors on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation.
This presentation discusses product candidates that are under preclinical or clinical evaluation and that have not yet been approved for marketing by the U.S.
Food and Drug Administration or any other regulatory authority. The presentation also includes select interim and preliminary results from an ongoing clinical trial as of specific data cutoff dates. Such results should be viewed with caution as final results may differ as additional data becomes available. Until finalized
SOLID
in a clinical study report, clinical trial data presented herein remain subject to adjustment as a result of clinical site audits and other review processes. No
TUMORS 90%
representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied.
This presentation also contains estimates and other statistical data made by independent parties or publicly available information, as well as other information based on our internal sources. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. We have not independently verified the accuracy or completeness of the data contained in these industry publications and other publicly available information. Accordingly, we makes no representations as to the accuracy or completeness of that data.
Arcellx Corporate Presentation | November 2023
2
Arcellx is a Different Kind of
Cell Therapy Company
Potential best-in-class therapy partnered with Kite, the global leader in cell therapy.
Scalable manufacturing and commercial footprint to support leadership
in a $12B+ market.
Sufficient capital to fund operations into 2026.
Reimagining Cell Therapy
Novel Synthetic Binding Domain
Single-infusion ddCAR
platform and
Dosable, controllable ARC-SparX platform
+
Positive Preliminary | Partnered Lead |
Clinical Results | Program |
Demonstrated 100% | Combining potential |
overall response rate | best in class program |
and deep durability in | with Kite's commercial |
CART-ddBCMA | and manufacturing |
multiple myeloma | expertise |
Phase 1 study. | |
Pivotal study enrolling |
ARC-SparX
Platform Potential
ACLX-001 Phase 1 clinical
trial in MM initiated in
2Q22
ACLX-002 Phase 1 clinical
trial in AML/MDS initiated in 4Q22
Built for
Success
Strong investor base
Exceptional team Wholly owned IP Well capitalized
Arcellx Corporate Presentation | November 2023
4
Future Milestones
Future Milestones | Anticipated Timing |
Present long-term clinical and median PFS data from Phase 1 | 2H23 |
clinical trial of CART-ddBCMA | |
Present preliminary data from iMMagine-1 Phase 2 pivotal trial | 2H24 |
Commercial launch for CART-ddBCMA | 2026 |
Arcellx Corporate Presentation | November 2023
5
Maximizing the Value of MM Opportunity with Kite Partnership
Positioned for Leadership | Global Collaboration | Long-term Value |
in CAR-T Space |
Presentation | November 2023
- Combining a potential best-in- class therapy with Kite's operational capabilities
- Proven manufacturing and commercial infrastructure with global cell therapy leader, Kite
- Leveraging synergies across both companies to accelerate patient access
- Co-developmentand co- commercialization of CAR-T ddBCMA with split profits in the U.S.
- Arcellx to receive low to mid-teen royalties ex-U.S.
- Arcellx and Kite to collaborate on next generation autologous and non-autologous programs incorporating ddBCMA
- Kite to have exclusive option rights to ARC-SparXprograms targeting BCMA or CS1 for use in myeloma
- Received $325M upfront payment and equity investment
- Kite will manufacture following tech transfer and bear the CMC commercial readiness costs
- Arcellx will continue to independently progress its development pipeline for new product candidates beyond myeloma
- Arcellx is well capitalized to fund operations through BLA filing
Arcellx Corporate
6
Kite Partnership Summary
FINANCIAL TERMS
Topline Economics
$325M
Total upfront consideration
- Upfront payment: $225M
- Equity investment: $100M
Contingent Milestones
Across all programs
- Up to $335M (ddBCMA)
- $635M (next-generation autologous)
- $508M (non-autologous)
Royalties
Tiered, low to mid-teens
- Co-promoteproducts outside U.S.
- Non-co-promoteproducts worldwide (includes next-gen autologous products if Arcellx does not elect to co-promote)
DEAL TERMS
Co-promote Products
(includes CART-ddBCMA & next-gen autologous products that Arcellx elects to co-promote)
Co-Development
- Joint development
- Arcellx will run iMMagine-1 pivotal trial
- Shared development costs limited to out-of-pocket costs and clinical manufacturing batch costs
- 50/50 in U.S.
- 40/60 (Arcellx/Kite) global studies outside U.S.
- 0/100 (Arcellx/Kite) international, country-specific studies outside the U.S.
Manufacturing
- Kite will solely bear CMC costs & associated capital expenses
- Kite will manufacture, following tech transfer
Co-Commercialization
In US
- Arcellx/Kite jointly responsible for commercialization
- Arcellx/Kite equally share profits and losses from directly-related myeloma commercialization
Outside US
- Kite responsible (at its sole cost) for commercialization
Arcellx Corporate Presentation | November 2023
7
Partnership Structure Creates Value While Maximizing Runway
Eliminates CMC
Infrastructure Build
Costs
Commercial readiness
borne by Kite
Downstream benefits in
COGS & timelines
$1B+ benefit
Reduces
Development
Costs
Cost Split, Development:
Costs limited to 3rd party & batch costs in U.S. including iMMagine-1
Kite fully bears int'l. (country-
specific) costs
Next-gen pipeline:
Next generation costs borne
by Kite with Arcellx Opt-in
(Autologous) and fully borne
by Kite with royalty
(Allogeneic)
Manages P&L while
leveragingKite infrastructure
Cost Split, Development:
Limited to OOP costs
- batch costs for clinical manufacturing
Cost Split, Commercial:
Limited to directly-related myeloma activities with defined expense categories
Accelerates
global
timelines
Quicker access to ex-U.S. markets at tiered low to mid-teen royalties
No upfront Arcellx
investments to build global infrastructure
Maximizes
cash
runway
Upfront cash infusion, reduced CapEx & other mechanisms stretch runway, limit development and commercial expenses
Arcellx Corporate Presentation | November 2023
8
Multiple Myeloma is a Significant Market Opportunity
2023 | |||
3rd most | Impacting | Limited Therapies | November |
common | 100,000 patients | comprise ~$20B global | |
| | |||
blood cancer | annually | market today | |
Corporate Presentation | |||
Incurable | Growing opportunity for | Total addressable | |
disease with | CAR-T solutions as more | market of $12B+ | Arcellx |
life expectancy | effective therapies move | ||
in CAR-T | |||
of just over 5 years | to earlier line patients | ||
9 |
Binding Domain Differentiated by Size and Stability
TCR1 | Bi-Valent |
Camelid VHh3 | |
(50kDa) |
scFv2 | (25kDa) |
(25kDa) |
D-Domain
(8kDa)
41BB | 41BB | 41BB | ||
CD3ζ | CD3ζ | CD3ζ | ζ | ζ |
CD3 | CD3 |
Arcellx Corporate Presentation | November 2023
1 Chan, KF. et al. 2018.,Nat Commun 9:1026-1026
2 Bjerragaard-Anderson, K., et al 2018. Sci. Rep., 8:10836-10836.
3 https://commons.wikimedia.org/wiki/File:1I3V_(Lama_VHH_domain_unligated).png#file | 10 |
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Arcellx Inc. published this content on 01 November 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 November 2023 04:18:43 UTC.