Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of drug candidates intended to transform existing treatment and prevention paradigms. Its lead Phase 3 antifungal candidate, rezafungin, will report Phase 3 data at the end of 2021. The potential peak sales opportunity for rezafungin in the US is ~$750M. In addition, the Company is developing Drug-Fc Conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform.
2. 2
T h e s e s l i d e s c o n ta i n f o r w a r d - l o o k i n g s ta te m e n t s w i t h i n t h e m e a n i n g o f t h e
P r i v a te S e c u r i t i e s L i t i g a t i o n Re f o r m A c t o f 1 9 9 5 .
The words “may,” “will,” “estimate,” “plan”,
“anticipate,” “expect,” “potential,” “could,”
“project,” and similar expressions (including the
negative thereof), are intended to identify
forward-looking statements. Because such
statements are subject to risks and uncertainties,
actual results may differ materially from those
expressed or implied by such forward-looking
statements. Such statements include, but are not
limited to, statements regarding Cidara’s research
and development efforts; preclinical and clinical
development activities; plans, projections and
expectations for and the potential effectiveness,
safety and benefits of, its product candidates,
including rezafungin, the Cloudbreak platform and
CD377; Cidara’s ability to successfully
commercialize its product candidates; and
potential ability to achieve milestones under its
respective collaborations with Mundipharma and
Janssen, and receipt of the related milestone
payments; and advancement of its strategic plans.
This presentation also contains estimates and
other statistical data made by independent parties
and by Cidara relating to market size and growth
and other data about Cidara's industry. These data
involve a number of assumptions and limitations,
contained in this presentation speak only as of the
date on which they were made. Cidara undertakes
no obligation to update such statements to reflect
events that occur or circumstances that exist after
the date on which they were made.
We have filed a registration statement (including a
prospectus) (File No. 333-228268) with the SEC for
the offering to which this presentation relates.
Before you invest, you should carefully read the
prospectus and the prospectus supplement, when
available, together with the information
incorporated by reference, as well as any free
writing prospectus that we or the underwriters
provide you in connection with the offering, for
more information about Cidara and the offering.
You may obtain those documents that are filed
with the SEC free of charge by visiting the SEC's
website at www.sec.gov. Alternatively, you may
obtain a copy of the prospectus supplement and
accompanying prospectus, when available, from
Cantor Fitzgerald & Co., Attention: Capital Markets,
499 Park Ave., 5th Floor, New York, New York
10022 or by email at prospectus@cantor.com.
and you are cautioned not to give undue weight to
such estimates. Projections, assumptions and
estimates of the future performance of the
markets in which Cidara operates are necessarily
subject to a high degree of uncertainty and risk,
including, Cidara's ability to obtain additional
financing; the success and timing of Cidara’s
preclinical studies, clinical trials and other research
and development activities; receipt of necessary
regulatory approvals for development and
commercialization, as well as changes to
applicable regulatory laws in the United States and
foreign countries; changes in Cidara's plans to
develop and commercialize its product candidates;
Cidara's ability to obtain and maintain intellectual
property protection for its product candidates; and
the loss of key scientific or management
personnel. These and other risks and uncertainties
are described more fully in Cidara's Form 10-Q as
most recently filed with the United States
Securities and Exchange Commission ("SEC“’)
under the heading “Risk Factors.”
Additional risks and uncertainties may emerge
from time to time, and it is not possible for
Cidara’s management to predict all risk factors and
uncertainties. All forward-looking statements
FORWARD-LOOKING STATEMENTS
3. 3
Rezafungin
• E x - U S /J a p a n
p a r t n e r
• P h a s e 3 d a ta
a nt i c i p a te d e n d o f
2 0 2 1
• N DA s u b m i s s i o n
p l a n n e d m i d - 2 0 2 2
Cloudbreak
• G l o b a l p a r t n e r
• F l u I N D s u b m i s s i o n
a nt i c i p a te d 1 2 / 2 1
• P h a s e 1 sta r t
a nt i c i p a te d e a r l y
2 0 2 2
CONFIDENTIAL
REZAFUNGIN
CLOUDBREAK® DRUG-Fc CONJUGATES
CIDARA INVESTMENT THESIS
4. 4
LEADERSHIP TEAM
J e f f r e y S t e i n , P h . D.
Tay l o r S a n d i s o n , M . D.
P r e e ta m S h a h , P h . D. , M B A
C a ro l Wa l d o
President and Chief Executive Officer
Trius, Quorex, Diversa
Chief Medical Officer
Merck, Cubist, Trius
Chief Financial Officer & Chief Business Officer
Brainstorm, Barclays, Caanacord Genuity
Senior Vice President, Regulatory Affairs & QA
Spero, Cubist, Amgen
Pa u l D a r u w a l a
L e s Ta r i , P h . D.
L a u ra N av a l ta
C h r i s t o p h e r Ku r t z
Chief Operating Officer
BMS, Vertex, Merck
Chief Scientific Officer
Trius, ActiveSite, Syrrx
Senor Vice President, Clinical Operations
Novalar, Vical, Baxter
Executive Vice President, Technical Operations
Gilead, Abbvie, Monsanto
5. 5
UP TO ~$1.3B IN POTENTIAL VALUE FROM EXISTING PARTNERSHIPS
• $30M upfront
• $9M equity investment
• $42M in development support
• $487M clin/reg/comm milestones
• Double-digit royalties in the teens
Program: Rezafungin | Rights: ex-US/Japan
~$568M
P h a s e 2 d a t a
• $27M upfront
• $58M in R&D support
• $695M clin/reg/comm milestones
• Mid to high single digit royalties
• Right of 1st negotiation on RSV program
Program: Influenza | Rights: Global
~$780M
P re c l i n i c a l d a t a
7. 7
ECHINOCANDINS
ANTIFUNGAL PIPELINE FOR INVASIVE DISEASE HAS DIMINISHED
• itraconazole
• fluconazole
• amphotericin
lipid forms (3)
• micafungin
• caspofungin
• anidulafungin
• posaconazole
• voriconazole
POLYENES
AZOLES
rezafungin
Number of New Antifungals
1980 1990 2000 2010 2020
5 5 1
Includes antifungals approved for systemic fungal infections.
8. 8
0 200 400 600
265
120
P3 Marketed
NDA
568
725
P2
P1
P3 Marketed
NDA
P2
P1
ANTIBACTERIALS
Melinta / Menarini: Delafloxacin
Paratek / Zai Labs: Omadacycline
Melinta / Menarini:
Vabomere, Orbactiv & Minocin
Ex-US; ex-Japan
China
Ex-US; ex-Japan
ANTIFUNGALS CAN HAVE GREATER VALUE THAN ANTIBACTERIALS
DATA AVAILABLE AT SIGNING
DEAL ($ MILLION)
RIGHTS
Basilea / Pfizer:
Cidara / Mundipharma: Rezafungin
ANTIFUNGALS
Ex-US; ex-Japan
Ex-US; ex-Japan*
0 200 400 600
120
Spero / Pfizer: SPR206 Ex-US; ex-Asia
P2
P2
* If approved by the FDA for the treatment / prevention indications
9. 9
REZAFUN GIN BE IN G DE V E LOPE D FOR IN DICAT ION S WIT H LARGE POT E N T IAL MARKE TS
Source: IQVIA, as of December 31, 2017
$0.5 Polyenes
$1.1 Echinocandins
$2.6 Azoles
OUTPATIENT
INPATIENT
$4.2 Billion
PROPHYLAXIS
TREATMENT
Rezafungin
Targets
Azoles
Azoles/Bactrim
Marketed
Echinocandins
Azoles/Bactrim
Pa tients in ta rg et in d ica tions s p a n in p a tient a n d ou tp a tient s ettin g s
10. 10
REZAFUNGIN’S POTENTIAL GLOBAL OPPORTUNITY SPANS ID AND HEMATOLOGY
Source: Global sales for Cancidas – IQVIA; Noxafil – 2018 Merck Annual Report. Antifungal market data from IQVIA, as of December 31, 2017.
MOSTLY TREATMENT MOSTLY PROPHYLAXIS
Cancidas
(caspofungin)
~$700M
Noxafil
(posaconazole)
~$700M
GLOBAL ANTIFUNGAL MARKET
$ 4 . 2 B I L L I O N
INFECTIOUS DISEASE HEMATOLOGY
11. 11
MOSTLY PROPHYLAXIS
US REZAFUNGIN POTENTIAL SALES OPPORTUNITY: ~$750M(Base Case)
IF APPROVED FOR BOTH TREATMENT AND PROPHYLAXIS INDICATIONS
Revenue projections are for peak year 2032 based on estimates and assumptions, including estimated patient populations, market share and pricing assumptions. Actual results could differ materially. Prophylaxis revenue is an estimate of the peak
sales potential, of which ~$223M is attributed to spontaneous product use that may occur outside of anticipated initial indication. Any such use will not be supported by Company promotion.
Rezafungin in Treatment
̴$375M
Rezafungin in Prevention
̴$375M
MOSTLY TREATMENT
INFECTIOUS DISEASE HEMATOLOGY
Detailed Illustrative Market Potential Assumptions available on our website in the “Research and Development Day Webinar” deck
12. 12
STRIVE PHASE 2 DATA IN CANDIDEMIA & INVASIVE CANDIDIASIS
Rob u s t d a ta s u p p ort ReST ORE Ph a s e 3 clin ical tria l
13. 13
PHASE 2:REZAFUNGIN SHOWED SUPERIORITY ON TIME TO NEGATIVE
BLOOD CULTURE COMPARED TO CASPOFUNGIN IN CANDIDEMIA SUBJECTS
Log-rank test (post hoc):
RZF vs CSP
p=0.0025
Daily doses
100%
0%
80%
60%
40%
20%
0 1 2 3 4 5
Rezafungin IV 400/200mg
Caspofungin IV 70/50mg
Days since first dose
6 7 8
Probability
of
negative
blood
culture
Weekly Dose
T IME TO N EGAT IV E BLOOD CULT URE
Data on file from STRIVE Phase 2 clinical trial.
14. 14
PHASE 2: 30-DAY ALL CAUSE MORTALITY – POST HOC ANALYSIS
Data on file from STRIVE Phase 2 clinical trial.
Using the same analysis method as planned for the Phase 3 study, a two-sided 95% confidence interval (CI) for the observed difference in the ACM rate (relevant Rezafungin group minus caspofungin
group) was calculated using the unadjusted method of Miettinen and Nurminen.
Post-hoc analyses do not establish effectiveness and should not be assumed to establish the same outcome in Phase 3.
S U P E R I O R I T Y N O N - I N F E R I O R I T Y
0
-20% 10%
-10%
FAV O RS R E Z A F U N G I N FAV O RS C A S P O F U N G I N
ReSTORE Phase 3 trial endpoint
requires upper limit of
confidence interval be below
20% threshold for FDA
Non-inferiority margin
20%
-24.7% +0.41%
-8.8%
Rezafungin 400/200; n = 46
95% confidence interval
15. 15
0 5 10 15
Days
REZAFUNGIN 400/200
% Neg. Blood Culture1 % Overall Cure2
Median Days in ICU1
CASPOFUNGIN
Rz Cf2 Rz Cf
Rz Cf 5
ICU DAYS
SAVED
28/38
1 DAY 5 DAYS
2 DAYS
27/50
31/36
32/49
34/46
34/61
% Neg. Blood Culture2
73.7
54.0
73.9
55.7
86.1
65.3
13 DAYS
18 DAYS
n/N n/N
n/N
PHASE 2: ADDITIONAL BENEFITS MAY BE DUE TO FRONT -LOADED DOSING
1. Soriano et al. Presented at ISICEM 2021 (Brussels).
2. STRIVE Phase 2: CID September, 2020.
16. 16
ReSTORE PHASE 3 TRIAL DESIGN MIRRORS STRIVE PHASE 2 TRIAL
2 3 4 5 6 7 8 9
5 14 30
N= 92
Caspofungin
Rezafungin
N= 92
Week
Day
Week 1 2 3 4 5 6 7 8 9
Global
Response
Global Response
(1 ENDPOINT – EMA)
All Cause Mortality
(1 ENDPOINT – FDA) End of Follow Up Period
400/200mg
70/50mg
Dose Optional dose
Dose Optional dose
1
Global Response is defined as Clinical Response (as assessed by the Primary Investigator), Mycological Response and Radiological Response (for qualifying invasive candidiasis patients only).
17. 17
REZAFUNGIN OVERALL PHASE 3 DEVELOPMENT PLAN
1. Phase 3 Primary Evaluable Population size.
P H A S E 3 T R E AT M E N T T R I A L
POTENTIAL INDICATION
PLANNED PHASE 3
SIZE
Treatment of candidemia & invasive
candidiasis
184 patients1 (20% NI margin)
FDA: Day 30 All-cause mortality vs SOC
Expect topline data by end of 2021
Prophylaxis against Aspergillus, Candida &
Pneumocystis in allogeneic blood and
marrow transplant patients
462 patients (12.5% NI margin)
P H A S E 3 P R O P H Y L A X I S T R I A L
OVERALL OBJECTIVE Day 90 Fungal free survival vs standard
of care
18. 18
CURRENT ANTIFUNGAL PROPHYLAXIS STANDARD OF CARE IS INADEQUATE
1. Ullmann AJ et al. Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease. N Engl J Med. 2007 Jan 25;356(4):335-47.
2. Vasconcelles MJ et al. Aerosolzed Pentamidine and Pneumocystis Prophylaxis after Bone Marrow Transplantation is Inferior to Other Regimens and is Associated with Decreased Survival and Increased
Risk of Other Infections. A. Society for BMT. 2000.
3. The PATH (Prospective Antifungal Therapy) Alliance registry and invasive fungal infections: update 2012.
35%
38%
34%
Bactrim
Fluconazole
Posaconazole
HIGH D IS CO NTIN UATION R ATE
BMT patients discontinue prophylaxis due to adverse
events and low tolerability
HIGH MORTALITY
90-day mortality in patients with invasive fungal infection3
52%
63%
Hem Malignancy
Blood and marrow transplant
1
1
2
19. 19
REZAFUNGIN: DESIGNED TO SIMPLIFY DOSING REGIMEN
Antifungal prophylaxis in allogeneic blood and marrow transplant setting
SOC for Candida and
Aspergillus
Day
80
70
60
50
40
30
20
10
-10 0
Transplant
SOC for
Pneumocystis
Rezafungin 400/200 once weekly
Candida, Aspergillus
and Pneumocystis
Current
Antifungal
Prophylaxis
Regimens
90
Posaconazole or voriconazole
Bactrim, dapsone or atovaquone
Posaconazole or voriconazole
Fluconazole
Fluconazole
Rezafungin
Regimen in
Ongoing
Phase 3 Trial
21. 21
CLOUDBREAK® COMBINES AN Fc MOIETY WITH POTENT ANTIVIRALS
Fc MOIETY SM TARGETING MOIETIES PEPTIDE FUSIONS
Extends PK and recruits
immune system
Single or multiple types of
small molecules with direct
antiviral activity can be
conjugated to the same Fc
Multiple TMs per Fc can
increase antiviral potency
and spectrum
22. 22
CLOUDBREAK ® COULD REPRESENT A NEW CLASS OF DRUG FC CONJUGATES: “DFCs”
Drug Fc Conjugate
23. 23
POTENTIAL ADVANTAGES OF DRUG -Fc-CONJUGATES
VIRUS
DFCs ARE DESIGNED FOR THE FOLLOWING
ADVANTAGES
• Multivalent binding increases potency
• Engaging different targets on the same virus
improves spectrum, decreases resistance
• Enables a single DFC to target multiple viruses
24. 24
Single dose / ̴3 months
Wild-type Fc (full immune engagement)
CD377 CD388
Single dose / ̴4-6 months
Mutant Fc (attenuated immune
engagement, improved PK, and
extended duration of action)
DFC DEVELOPMENT CANDIDATES TARGETING INFLUENZA
We believe these are
the first agents with
potential for
universal, season-long
flu protection in all
patient populations.
CD377 and CD388 share the same targeting
moiety, linked to different Fc fragments.
25. 25
1 SC/IM dose/season
Pan Flu
Poor vaccines
Pandemic Preparation
FLU
Janssen
Pharmaceuticals
PRE-CLINICAL INFLUENZA DATA SUPPORTS POTENTIAL TO ADDRESS
ADDITIONAL INDICATIONS
RSV
Seasonal
Prevent | Treat
1 SC/IM dose/season
No vaccine
No Good Treatment
HIV
Chronic
Maintain | PREP
2-4 SC doses/year
Alone or in combo
Daily pills for life
SARS-CoV-2
1 SC/IM dose/ season
Pandemic
U N M E T
M E D I C A L
N E E D
S T R A T E G I C
F O C U S
T A R G E T
P R O F I L E
Seasonal & Pandemic
Prevent | Treat
Seasonal & Pandemic
Prevent | Treat
26. 26
FAVORABLE RSV GROWTH INHIBITION DATA WITH INVESTIGATIONAL SINGLE
MOLECULE DFC COCKTAIL
RVC-A
RVC-B
RVC-C
650EC50 (nM)
0.2EC50 (nM)
<0.001EC50 (nM) 4.0EC50 (nM)
RSV A2 Growth Inhibition
Investigational single
molecule cocktail
27. 27
INVESTIGATIONAL HIV SINGLE MOLECULE COCKTAIL DFCs OBSERVED TO BE
ACTIVE AGAINST HIV CELLS IN VITRO
SM CONJUGATE PEPTIDE FUSION DUAL HIV CONJUGATE
HVC-A HVC-B2 HVC-C
1.. CEM-SS cells and HIV-1 IIIB live virus 2.
CC50 > 10000 nM
Optimized GP120
inhibitor conjugate
Viral envelope binding
peptide
Investigational single
molecule cocktail
Full activity observed in
presence of human
serum
TEMSAVIR
EC50 (nM) = 0.02
0.02 EC50 (nM)1
EC50 (nM)1
0.02 0.009 0.003
EC50 (nM)1 EC50 (nM)1
30. 30
1ST GENERATION DFC CANDIDATES: EQUIPOTENT IN -VITRO TO COMPETITOR
MOLECULES
Discovery Preclinical IND-Enabling Phase 1
CBO−A
EC50, (nM)
CBO−B
CBO−C
CBO−D
2.6
2.6
1.2
4.7
SM DFC CONJUGATES
Small Molecule
EC50, (nM)
1.3
COMPETITOR PROGRAM
All are
structurally
different
Cidara’s early DFC
candidates
represent an
excellent starting
point for
development in
oncology
Next steps: single
molecule cocktail
candidates
31. 31
CLOUDBREAK DFCs ARE A NEW POTENTIAL CLASS OF DRUG
DFCs HAVE THE POTENTIAL
to generate single molecule cocktails that can target
multiple viruses or multiple pathways in oncology.
1. NEAR-TERM EXPECTED MILESTONES: Expected IND
submission CD388 (Influenza) at the end of 2021;
initiation of Phase 1 trials in Q1 2022, if authorized by the
FDA to proceed
2. ACCELERATING DISCOVERY: Experience, learning, and
established infrastructure enables faster development
3. NEW INDICATIONS: Early data from new programs
exemplify potential expansion into new viral indications
and oncology
A single-molecule cocktail has
the potential to improve
potency, spectrum across many
indications
32. 32
FINANCIAL OVERVIEW
1. Information listed here is as of September 30, 2021 (as disclosed in our 10-Q filing).
2. In May 2021, Cidara received from Janssen Pharmaceuticals the previously disclosed $27.0 million upfront payment when the Cloudbreak influenza License and Collaboration Agreement became effective.
3. Includes (i) 49,621,543 shares of common stock and (ii) 10,442,780 shares of common stock issuable upon the conversion of Series X Convertible Preferred stock, both as of September 30, 2021. Each share of Series X Convertible
Preferred is convertible into 10 shares of common stock.
4. Amounts reflect a rolling two-quarter period ending on the date noted. Amounts shown are historical and may not be indicative of future results.
5. Represents net cash used in operations of $(8.5)M adjusted to remove $27.0M up front payment from Janssen, $8.5M received pursuant to the Mundipharma cost share, and $3.1M received pursuant to the Janssen cost reimbursement.
6. Gross proceeds of $38.45M from offering on October 8, 2021, including exercise of greenshoe.
Important Information September 30, 20211
Cash and Restricted Cash $40.3M
PacWest Term Loan – Remaining Principal $3.7M
May 2021 Janssen Upfront Payment2 $27.0M
Common Stock Outstanding 49,621,543
Common Equivalent Shares Outstanding3 60,064,323
Summary Consolidated
Cash Flow Information
Rolling two-quarter
period ended
September 30, 20214
Operating Cash Burn5 $(47.1)M
Janssen up front payment $27.0M
Mundipharma Cost Share Payments $8.5M
Janssen Reimbursement Payments $3.1M
Net Cash Used in Operations $(8.5)M
ATM Equity Proceeds Less Term Loan Payments $0.1M
Net Cash Outflow $(8.4)M
On October 8, 2021, Cidara raised an additional $38.45 million in a confidentially marketed public offering
33. 33
CIDARA IS MUCH MORE THAN A TYPICAL ID COMPANY
R E Z A F U N G I N
T R E AT M E N T
R E Z A F U N G I N
P R O P H Y L A X I S
C L O U D B R E A K D F C
S T R AT E G I C F O C U S
O U R T E A M
Designed to enable fast clearance of infection, early discharge
Potential to transform the care of BMT patients
Radically different approach to prevent and treat serious diseases
Goal to develop transformative long-acting products for
fungal and viral diseases
Experienced creators of shareholder value