UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 22, 2017
CALADRIUS BIOSCIENCES, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware (State or Other Jurisdiction of Incorporation) | 001-33650 (Commission File Number) | 22-2343568 (IRS Employer Identification No.) |
106 Allen Road, 4th Floor, Basking Ridge, NJ 07920
(Address of Principal Executive Offices)(Zip Code)
(908) 842-0100
Registrant's Telephone Number
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
x | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.02 Termination of a Material Definitive Agreement
As previously reported on the Current Report on Form 8-K of Caladrius Biosciences, Inc. (the “Company”), dated September 15, 2016, on September 14, 2016, the Company entered into Securities Purchase Agreements (the “Purchase Agreements”) with certain accredited investors, including Newhall Construction, Ltd. (“Newhall”), pursuant to which the investors agreed to purchase an aggregate of 4,449,153 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), at a purchase price of $4.72 per share in a private placement. The investments were placed in two tranches: (i) up to $12.6 million upon the initial closing (the “Initial Closing”), and (ii) up to $8.4 million, subject to certain conditions, including the enrollment of 70 subjects in the Company’s Phase 2 CLBS03 clinical trial, in a second closing (the “Second Closing”). The Initial Closing occurred on September 19, 2016 and the Second Closing, if any, will occur within ten days after the satisfaction or waiver of the certain conditions set forth in the Purchase Agreements. The aggregate gross proceeds for the sale of the shares of Common Stock at the Initial Closing was $6.6 million, which, as further discussed below does not include $6.0 million expected to have been received by Newhall.
The Purchase Agreement relating to Newhall’s investment (the “Newhall Purchase Agreement”) contains certain conditions related to the purchase and sale of Common Stock. As a consequence of Newhall’s failure to satisfy the conditions for the Initial Closing, including Newhall’s failure to pay the purchase price for the shares of Common Stock at the Initial Closing, the Company terminated the Newhall Purchase Agreement on March 22, 2017, and no shares of Common Stock were issued to Newhall. As a result, a total of 1,416,305 shares were issued to the investors at the Initial Closing. Up to 932,204 shares remain subject to issuance at the Second Closing, if any, in connection with the receipt of up to $4.4 million.
Item 7.01. Regulation FD Disclosure.
A copy of a slide presentation that the Company will use at investor and industry conferences and presentations is attached to
this Current Report as Exhibit 99.1 and is incorporated herein solely for purposes of this Item 7.01 disclosure. The information
in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of such section. The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be incorporated by
reference into any filing under the Securities Act of 1933, as amended or the Exchange Act, regardless of any incorporation by
reference language in any such filing. This Item 7.01 will not be deemed an admission as to the materiality of any
information in this Item 7.01 that is required to be disclosed solely by Regulation FD.
Item 9.01. Financial Statement and Exhibits.
(d) Exhibits.
Exhibit No. | Description |
99.1 | Caladrius Biosciences, Inc. Corporate Presentation, March 2017 |
SIGNATURES
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 hereunto duly authorized.
CALADRIUS BIOSCIENCES, INC. | ||||
By: | /s/ David J. Mazzo | |||
Name: | David J. Mazzo, PhD | |||
Title: | Chief Executive Officer | |||
Dated: March 22, 2017
Corporate Presentation
David J. Mazzo, PhD
Chief Executive Officer
March 2017 | NASDAQ: CLBS
Forward-looking statements advisory
Additional Information About the Transaction and Where to Find it: Caladrius intends to file with the Securities and Exchange Commission (“SEC”)
and mail to its stockholders a proxy statement in connection with, among other things, the proposed sale to Hitachi Chemical Co. America, Ltd.
(“Purchaser”) of the 80.1% membership interest in PCT that Purchaser does not already own (the “Sale”). Investors and stockholders of Caladrius are
urged to read the proxy statement and the other relevant materials when they become available because they will contain important information
about Caladrius and the Sale. The proxy statement and other relevant materials (when they become available), and any other documents filed by
Caladrius with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov. In addition, investors and stockholders may obtain free
copies of the documents filed with the SEC by Caladrius by directing such requests to Caladrius Biosciences, Inc., 420 Lexington Avenue, Suite 350, New
York, NY 10170, Attn: Jacquelyn Briggs or jbriggs@caladrius.com, Telephone: (646) 606-2221.
Participants in the Solicitation: Caladrius and its directors and executive officers may, under SEC rules, be deemed to be participants in the solicitation
of proxies from Caladrius’ stockholders in connection with the Sale. Information regarding Caladrius’ directors and executive officers is contained
in Caladrius’ proxy statement on Schedule 14A filed with the SEC on May 10, 2016. Additional information regarding the participants in the
solicitation of proxies in respect of the Sale and a description of their direct and indirect interests, by security holdings or otherwise, will be
contained in the proxy statement when it becomes available.
Safe Harbor for Forward Looking Statements: This Corporate Presentation contains forward-looking statements within the meaning of Private
Securities Litigation Reform Act of 1995, including forward-looking statements regarding the Sale, the possibility of obtaining the milestone payment, the
possibility of obtaining stockholder or other approvals or consents for the Sale and Caladrius’ future prospects. These statements are neither promises nor
guarantees, but involve risks and uncertainties that could cause actual events or results to differ materially from those set forth in the forward-looking
statements, including, without limitation: risks and uncertainties relating to potential adverse reactions or changes to business relationships resulting from
the announcement or completion of the Sale; unexpected costs, charges or expenses relating to or resulting from the Sale; litigation or adverse judgments
relating to the Sale; risks relating to the completion of the proposed Sale, including the risk that the required stockholder vote might not be obtained in a
timely manner or at all, or other conditions to the completion of the Sale not being satisfied; any difficulties associated with requests or directions from
governmental authorities resulting from their review of the Sale; any changes in general economic and/or industry-specific conditions; and other risks
detailed in Caladrius’ filings with the SEC, including those disclosed under “Item 1A. Risk Factors” in Caladrius’ Annual Report on Form 10-K filed with the
SEC on March 17, 2017 and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC. You are cautioned not to place undue
reliance on forward-looking statements, which speak only as of the date of this Corporate Presentation. Caladrius does not intend, and disclaims any
obligation, to update or revise any forward-looking information contained in this Corporate Presentation or with respect to the matters described herein.
2
Caladrius transforms cells into therapies
3
Caladrius historical hybrid business model
4
Cell
Therapeutics
CLBS03
CDMO
PCT
Caladrius business model evolution plan
5
CDMO
PCT
Cell
Therapeutics
CLBS03
Caladrius business model evolution plan
6
CDMO
PCT
Cell
Therapeutics
CLBS03
Caladrius business model evolution – two healthy companies emerge
7
Cell
Therapeutics
PCT
CDMO
Caladrius unlocks PCT value and preserves intimate working relationship
8
Capital for Growth
Cell
Therapeutics
PCT
CDMO
Focused, funded and poised for growth1
• Pure-play Cell Therapy
therapeutics development company
• Two technology platforms on which to build
- T regulatory cells for immune modulation
- CD34 for ischemic repair
• On-going landmark phase 2 study
of CLBS03 in recent onset type 1 diabetes
- Strategic relationship with Sanford Research
(CLBS retains all product rights)
- ~$12.2 million CIRM grant awarded
• Phase 2 protocol in Critical Limb Ischemia
for CLBS12 ready to initiate in Japan
- Positive results should qualify product for early
conditional approval in Japan
• Well-funded with cash on hand >~$70 million
• Debt-free
9
1. After the expected PCT sale in May 2017
Immune Modulation
10
T regulatory cell technology platform built on a strong foundation
• T cell technology licensed from University of California at San Francisco
(Jeffrey Bluestone – pioneer in T cell biology, et al) and the Centenary
Institute
• Autologous ex-vivo expanded polyclonal T regulatory cells
• Exclusive rights to an international portfolio of issued and pending patents
• PCT-developed and optimized proprietary manufacturing process
- Discounted development and manufacturing services rates from PCT for
seven years
11
T Regulatory Cells (Tregs):
Restoring immune balance and function
• Deficiency in number or function of Tregs vs. T effector cells manifests as
autoimmune disease
• Augmentation of number/potency of Tregs is intended to restore the immune
system to its “native” state and reduce/eliminate autoimmune disease symptoms
1 Normal immune system:
immune balance
2 Autoimmunity:
immune imbalance
3 Infusion of Tregs:
balance restored
T regulatory cells T effector cells Natural polyclonal T regulatory cells
12
Polyclonal T regulatory cell therapy is potentially applicable across multiple
autoimmune, alloimmune and allergic diseases
13
Combined markets represent a multi-billion dollar opportunity:
1. Pending grant application to fund a Phase 1 study in NMO with decision expected in 1H 2017
2. Global Patient numbers include total patients from US, EU and Japan only.
3. Annual incidence of type 1 diabetes for patients <15 years old. IDF Diabetes Atlas, 7th Edition.
Recent-Onset
Type 1
Diabetes
Neuromyelitis
Optica (NMO)1
Uveitis Cutaneous
Lupus
Graft-versus-
host Disease
(GVHD)
Kidney
Transplant
Scleroderma SLE - Lupus
Global
Patients2
86,0003 13,930 254,869 1,993,080 12,529 3,123 165,537 553,968
Clinical
Study
Endpoints
C-peptide,
insulin use
EDSS,
visual acuity
Response rates CLASI,
Skindex-29
GHVD-free
survival
Failure rates mRSS,
CRISS,
sHAQ
BILAG,
SELENA-
SLEDAI
Biomarkers C-peptide,
others
NMO-IgG
antibody
N/A Cell type
analysis
N/A Renal function Cytokines,
B cells
B cell counts
Additional potential indications:
• Lupus Nephritis • Steroid resistant asthma • Rheumatoid arthritis • Multiple sclerosis • Bullous pemphigoid • Crohn’s Disease
Simple, cost-effective, proprietary
Manufacturing process is scalable and commercially viable
• Simple and efficient clinical manufacturing process:
- Simple, less intrusive cell collection process (whole blood or, eventually, apheresis)
- Reliable and well-characterized cGMP process
- Extremely high Phase 2 manufacturing success rate to date
- Introduction of cryopreservation step(s) is technically likely
1 Day 1: Blood draw or
apheresis from patient
3 Day ~14: Infusion of Treg
therapy to same patient
Collection Processing Infusion
2 Day 2: Treg isolation,
activation & expansion
14
CLBS03: Recent onset type 1 diabetes program overview
• Ongoing Phase 2 clinical study in T1D (T-Rex trial)
- California Institute for Regenerative Medicine up to $12 million grant awarded upon achievement of
certain milestones
- DSMB satisfactory assessment of safety of initial cohort achieved ahead of schedule
- Final cohort enrollment underway
• Strategic collaboration with Sanford Research
- $5 million equity investment
- Providing operating support for trial and clinical sites
• International regulatory recognition
- FDA Fast Track designation – First time granted to a T1D program
- FDA Orphan designation
- EU ATMP (Advanced Therapeutic Medicinal Product) classification
15
T Regulatory Cell (Tregs) therapy offers:
An attractive medical and commercial opportunity for T1D
• Each year >18,000 newly diagnosed patients under 20 years of age
in US1; 3% CAGR worldwide2
• No curative treatments, only lifelong insulin therapy (often with
serious co-morbidities)
• Preserving remaining beta cell function in recent onset patients is
expected to slow/stop disease progression and lead to long-term
medical and pharmaco-economic benefits
1. SEARCH for National Diabetes Statistic Report, 2014
2. Maahs DM, et al. Endocrinol Metab Clin North Am. 2010
16
CLBS03 occupies a unique position in the type 1 diabetes treatment paradigm
17
Chronic symptom
treatment
Disease Modification
(CLBS03)
Function regeneration
Approach Treatment of symptoms Reduce or eliminate
disease progression;
potentially curative
Replace ability to produce insulin
with new cells/organs; potentially
curative
Insulin
Impact
Improve therapeutic effect
and/or efficiency of delivery
of insulin and/or insulin
analogs
Avoid or reduce need for
insulin by preserving active
beta cells
Avoid or reduce need for insulin by
providing new beta cells
Availability Currently available and
more in development
Currently in Phase 2 trial Many years of development
remaining
US Study1 EU Study2
Dose 4-dose escalation cohorts
(0.05 x 108 to 26 x 108 cells)
1 infusion (10 or 20 million cells/kg) or
2 infusions (30 million cells/kg total)
Patients
14 adult patients with established T1D 22 patients aged 5-18 with T1D
Results • Demonstrated safety/tolerance
• No cytokine release, infectious complications
or infusion reactions observed
• >500 fold dose range tested
• Established manufacturing feasibility
• Can produce expanded Treg cell population
with enhanced functionality
• Implied durability of effect
• Infused Tregs were stable and detected
in peripheral circulation for 1 year
At 12 months:
• 6 treated patients achieved remission3
• 2 treated patients achieved insulin independence
Published Phase I studies demonstrated Treg cell therapy to be:
Well tolerated1,2, durable1
and preserving of beta cell function in children2
1. Bluestone, et al. Science Translational Medicine 2015
2. Marek-Trzonkowska, N et al. Clinical Immunology 2014
3. Remission Definition: Daily dose of insulin ≤ 0.5 UI/kg body weight & fasting c-peptide > 0.5 ng/ml at 12 months after recruitment
0
0.2
0.4
0.6
0.8
1
1.2
M
e
a
n
C
-p
e
p
ti
d
e
(n
g
/m
l)
Fasting C-peptide levels stabilized
One
Year
Control, n=10
Treatment, n=12
Day
0
Month 4
18
T-Rex Study:
Phase 2 trial in adolescents with T1D initiated in March 2016
19
Rigorous
Design
• Double-blind, placebo-controlled, randomized (1:1:1) trial
• Adolescent patients ages 12 to <18 with recent-onset (diagnosed within last 100 days) T1D
Standard
Endpoints
• Preservation of C-peptide level, insulin use, severe hypoglycemic episodes, glucose
and hemoglobin A1c levels
Study
Size
• 111 patients enrolled across ~12 study sites in the USA
Power • 80% power to detect a 0.2 pmol/mL difference in AUC mean C-peptide between active and placebo
Study
Execution • Strategic collaboration with Sanford Research providing operational resources and capital
Treatment • Single infusion of CLBS03 (dose cohorts of 2.5 or 20 million cells/kg) or placebo infusion (control)
NCT02691247 at www.clinicaltrials.gov for more details
2019
T-Rex Study:
Timeline including near-term milestones
20
• Last (111th)
patient randomized
• 6-month follow-up
of 50% of subjects
• 50% of
subjects treated
• 70th subject
enrolled
Interim Analysis of Early
Therapeutic Effect
Topline Data:
Primary Efficacy Endpoint
1 year Analysis
2016
Study initiation in
March 2016
2017 2018 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q
Ischemic Repair
21
CD34 cell therapy is supported by a strong rationale
• CD34 cells have been investigated in clinical studies encompassing >700 patients
- Pre-clinical studies document improved microcirculation1
- Phase 2 clinical studies consistently show benefits in safety and function
o Reduced amputation in critical limb ischemia2
o Improved function in claudication3
o Reduced angina and improved ETT in refractory angina4
o Improved mortality and LVEF in dilated cardiomyopathy5
• Opportunities exist across multiple underserved cardiovascular indications
- Coronary microvascular dysfunction (CMD)
- Refractory angina
- Critical limb ischemia (CLI) in Japan
22
1. Kalka et al. PNAS. 2000; Schatteman et al. J Clin Invest 2000.; Madeddu et al.
FASEB. 2004.
2. Losordo et al. Circ Cardiovasc Interv 2012.
3. From US study (n=17); Not yet published
4. Losordo et al. Circ Res 2011.; Povsic et al. JACC Cardiovasc Interv. 2016.
5. Vrtovec et al. Circ Res 2013.
23
Design
• Prospective, open label, controlled, randomized trial
• Patients with no-option CLI
Advantageous
Primary
Endpoint
• Time to continuous CLI free status
Study
Size
• 35 patients enrolled across multiple centers in Japan
Treatment • Up to 106 autologous G-CSF-mobilized peripheral blood-derived CD34+ cells/kg per affected limb
Control/
comparator
• SOC pharmacotherapy with drugs approved in Japan (e.g. antiplatelets, anticoagulants and
vasodilators)
• The choice of pharmacotherapy will be made by the investigators
Mode of
administration • Intramuscular, 20 injections in lower limb in single administration
Japanese development program for critical limb ischemia:
Designed to leverage new regulatory path to early conditional approval
• Phase 2 protocol and CMC strategy completed in consultation with Japanese PMDA
Multiple grant opportunities in cardiovascular indications
24
Indication
Coronary Microvascular
Dysfunction
Coronary Microvascular
Dysfunction
Grantor
NIH Small Business Innovation
Research
Department of Defense
Decision Expected 2Q17 2H17
Total Award
Sought
$1.9 million $6.9 million
Trial Phase Early Phase 2 Phase 2
Number of
Subjects
20 60
Study Initiation Within 5 months of award date 1Q 2018
Timing of Results 2018 2019/2020
Experienced executive team with broad domain-specific expertise
David J. Mazzo, PhD
Chief Executive Officer
30+ years of experience in all aspects of large and emerging
global biotech, biopharma company operations, successful
international drug development
Joseph Talamo, CPA, MBA
Senior VP and Chief Financial Officer
Versatile finance executive with leadership experience in
publicly traded development and commercial-stage
companies; 20+ years of experience
Douglas W. Losordo, MD
Senior VP and Chief Medical Officer
Leader in cell therapy research and development; renowned
clinician with noteworthy academic and industry credentials;
25+ years of experience
Todd Girolamo, JD, MBA
Senior VP, General Counsel
and Corporate Secretary
Seasoned attorney with 25+ years of legal, finance and
biotechnology industry experience
Raj Prabhakar, MBA
Senior VP, Business Development
20+ years experience, 16+ in biopharma sector. Previously at
Celsion, PATH Global Vaccines, Osiris. Extensive transaction
experience in oncology and Asia-Pacific.
25
2016 Goals Results in 2016
Grow and expand the PCT business
on all fronts
• 57% annual revenue growth to annual revenue of $35.3 million
• Initiated global collaboration and license agreement with Hitachi Chemical
• Began 5-year agreement with Adaptimmune for late-stage clinical supply
Advance CLBS03
• Initiated Phase 2 T-Rex trial in T1D 1Q 2016
• Completed enrollment of first cohort of 19 patients in 3Q 2016
• Procured financial and clinical support from Sanford Research
Execute with financial discipline
• Reduced R&D (37%) and SG&A (32%) expenses significantly from 2015
levels
Monetize non-core assets • Out-licensed certain oncology and dermatology product candidates
Caladrius established a:
Track record of achievement based on execution of the 2016 strategic plan
26
2017 Capital Catalysts and Impact
YE2016
Financial
Information
Hitachi Acquisition of 80.1% of PCT
from CLBS
CIRM CLBS03
Grant Award
(March 2017)
Sept. 2016 PIPE –
Second Tranche
Cash: $14.7m • $5m on signing agreement
(received March 17, 2017)
• $2m from Sanford (accelerated
payment from second tranche of
Sept. 2016 PIPE)
• $65m from Hitachi on closing, plus
up to $5m after indemnification
escrow released (expected May
2017)*
Up to $12.2m with
initial payment of
~$5.5m expected in
April 2017
$2.4m triggered by
70th patient enrolled
in T-Rex Study
(expected 2Q17)
Long-term debt:
$5.7m
• Settle any remaining debt on
closing of PCT sale
27
Select Caladrius financial information
*pending, among other closing conditions, CLBS stockholder approval
Expected Timeframe
CLBS03
• DSMB safety assessment on 1st patient cohort Completed 2016
• Initiation of enrollment of 2nd patient cohort Completed 2016
• 50% of patients treated:
starts clock to 6-mos. follow-up interim analysis
Mid-2017
• 70th patient enrolled: triggers capital infusion Mid-2017
• Interim analysis assessing early therapeutic effect:
6 months post treatment of 50% patients
Late 2017/Early 2018
• Analysis of 12 month data (primary efficacy endpoint); Go/No Go to Phase 3 Late 2018/Early 2019
• 2-year follow-up complete Late 2019
Other Technologies
• Initiate 35 patient Phase 2 trial in Japan for critical limb ischemia 2H 2017
• Begin patient enrollment in 20 patient Phase 2 trial for coronary microvascular
dysfunction based on NIH SBIR grant
2H 2017
• Additional grant funding opportunities: CD34 program, multiple clinical indications 2017
• Licensing opportunities for CLI in Japan and immuno-oncology in China:
CLI program eligible for early conditional approval
2017
Financing
• Closing of Hitachi Chemical purchase of PCT from Caladrius for $75 million plus
milestone (subject to shareholder approval and customary closing conditions)
Early May 2017
Caladrius offers multiple potential near-term value creating milestones
28
Investor Relations Contact
LHA Investor Relations
Anne Marie Fields, Senior Vice President
Phone: 212.838.3777
Email: afields@lhai.com
Web: www.caladrius.com
29
NASDAQ: CLBS
PCT: Cell & Cell-Based
Gene Therapy CDMO
30
PCT has been:
A comprehensive development and manufacturing partner for 18 years
• Expertise in multiple cell therapy types and therapeutic applications, including:
- CAR-T, TCR, T-cell, NK cell, dendritic cells and CD34+ products, among others
31
cGMP Infrastructure Manufacturing Development
cGMP
Manufacturing
Technology
Transfer
Quality
Systems
GTP
Processing
Global Logistics
& Storage
Innovation,
Engineering and
Automation
Process
Development
& Optimization
Analytical
Development
Regulatory
Consulting
Process
Control
PCT’s deep experience is evidenced by:
An extensive client list of renown cell therapy companies
• Historically: >100 clients, 20,000 products and 6,000 patients
• Critical contribution from PCT to development and/or clinical manufacturing
• Several clients expected to be among next wave to reach commercialization
32
*Some clients request that PCT maintain their anonymity
Selected Clients*
Dedicated capacity contracts with PCT
465 Phase 2
1. Informa/Alliance for Regenerative Medicine. Regenerative medicine clinical trials are as of December 31, 2014 and December 31, 2016. Note that some Phase 2
trials are pivotal trials. 2. Based on company projections. FDA approvals based on pivotal cell therapy trials and historical rates of Phase 3 success and approval.
• Expanding industry-wide pipeline
with increasing number of players
• Attractive revenue growth for PCT based on
clinical contracts alone (2016 projection >30%)
• Maturing development programs with
commercial products on the near-term horizon
• Major revenue growth opportunity for PCT
based on transitioning clients to
commercial manufacturing contracts
378 Total
Regenerative
Medicine
Clinical Trials1
FDA-Approved
Cell Therapies2
11
>20
2016 2020 projected 2014 2016
206 Phase 2
39 Phase 3
802 Total
133 Phase 1
66 Phase 3
271 Phase 1
33
PCT growth driven by:
Growing and maturing cell and cell-based gene therapy market
PCT’s modern cGMP manufacturing facilities offer flexibility and mitigate risk
• Allendale, NJ (30,000 ft2) - owned
- 3 US-compliant cleanrooms
- 5 EU and US-compliant cleanrooms
(expansion completion in 2017)
- Commercial product infrastructure
• Mountain View, CA (25,000 ft2) - leased
- 7 US-compliant cleanrooms
- Dedicated clinical manufacturing
• Both locations feature:
- Process development, process and quality
control, cryostorage capabilities
- Convenient proximity to major transportation
hubs (EWR, LGA, JFK / SFO, SJC, OAK)
34
Manufacturing Present Manufacturing Future
PCT delivers:
A strategic solution that moves well beyond fee-for-service
35
Clinical
Manufacturing
Process
Development
Commercial
Manufacturing
Strategic
Manufacturing
Assessment Cell therapy
product concept
Client may enter
at any stage