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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): August 5, 2024
REZOLUTE, INC.
(Exact Name of Registrant as Specified in Charter)
Nevada |
|
001-39683 |
|
27-3440894 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
275 Shoreline Drive, Suite 500, Redwood City,
CA 94065
(Address of Principal Executive Offices, and
Zip Code)
650-206-4507
Registrant’s Telephone Number, Including
Area Code
Not Applicable
(Former Name
or Former Address, if Changed Since Last Report)
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 (see General Instruction
A.2. below):
¨ |
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, par value $0.001 per share |
RZLT |
Nasdaq Capital Market |
Indicate by check mark
whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company
¨
If an emerging growth
company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01 |
Regulation FD Disclosure. |
On
August 5, 2024, Rezolute, Inc. (the “Company”) issued a press release announcing clearance by the U.S. Food and Drug
Administration for its Investigational New Drug application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor
hyperinsulinism. Additionally on August 5, 2024, the Company made available an updated Corporate Presentation on the Investor
Relations page of its website, which will be used at investor and other meetings. A copy of the press release and Corporate
Presentation are attached hereto as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and is incorporated herein by
reference.
The
information in this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, 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 liability
of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange
Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current
Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
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.
|
REZOLUTE, INC. |
|
|
|
|
|
|
DATE: August 5, 2024 |
By: |
/s/Nevan Charles Elam |
|
|
Nevan Charles Elam
Chief Executive Officer |
Exhibit 99.1
Rezolute Announces
FDA Clearance of IND Application for Phase 3 Registrational Study of RZ358 for Treatment of Hypoglycemia Due to Tumor Hyperinsulinism
Second rare disease program with RZ358 in Phase
3 development
Follows successful treatment of multiple patients
with tumor hyperinsulinism
under the Company’s Expanded Access Program
REDWOOD CITY, Calif., August 5, 2024 –
Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company
committed to developing novel, transformative therapies for serious rare diseases, today announced that it received U.S. Food and Drug
Administration (FDA) clearance for its Investigational New Drug (IND) application for RZ358 (ersodetug) to treat hypoglycemia in patients
with tumor hyperinsulinism (HI). The Company is initiating start-up activities for the study which will be primarily conducted in the
U.S. and patient enrollment is planned to commence in the first half of 2025. Ersodetug is also being studied in an ongoing global, pivotal,
Phase 3 clinical trial in patients with congenital HI. Topline data from that study is expected in mid-2025.
“Hypoglycemia associated with tumor HI requires
treatment to prevent serious adverse outcomes and to improve patients’ daily function and quality of life, including enabling them
to receive tumor directed therapies,” said Brian Roberts, M.D., Chief Medical Officer at Rezolute. “We are encouraged by the
substantial real-world benefit we’ve witnessed in tumor HI patients who have previously received ersodetug in our Expanded Access
Program, coupled with the safety and efficacy demonstrated in clinical studies in patients with congenital HI, a similar condition. We
believe that the clearance of our IND for this Phase 3 study reflects FDA’s recognition of the potential for ersodetug to address
this serious unmet need and we are excited to be moving one step closer to a potential universal treatment for hypoglycemia caused by
all forms of HI.”
The Phase 3 registrational study is a double-blind,
randomized, placebo-controlled trial of 24 participants who have inadequately controlled hypoglycemia because of tumor HI. Eligible participants
will be randomized in 1:1 fashion (12 per treatment arm) to receive ersodetug 9 mg/kg per week or matched placebo, as an add-on to standard
of care. Up to 24 additional participants may be enrolled into an open-label arm, in participants whose hypoglycemia is being managed
by IV glucose in a hospital setting. Following a 6-week pivotal treatment period, all participants may receive ersodetug in open-label
extension. The primary endpoint is the change in Level 2 (moderate) and Level 3 (severe) hypoglycemia events by self-monitored blood glucose.
Additional endpoints include overall hypoglycemia events, time in hypoglycemia by continuous glucose monitor, patient reported quality
of life, hospitalizations, and change in glucose requirements (for open-label hospitalized participants).
Ersodetug is a fully human monoclonal antibody
that binds to an allosteric site on the insulin receptor at target tissues such as liver, fat and muscle. Ersodetug counteracts excess
insulin receptor activation caused by insulin and related hormones thereby correcting hypoglycemia. Ersodetug has the potential to be
universally effective at treating hypoglycemia caused by any form of HI, including congenital or acquired forms.
About Tumor Hyperinsulinism (HI)
Tumor HI is a rare disease that may be caused
by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell tumors (NICTs), both of which lead to hypoglycemia as a result
of excessive activation of the insulin receptor. Insulinomas are the most common type of ICT and may cause hypoglycemia by stimulating
the over production of insulin. A variety of different NICTs, particularly hepatocellular carcinoma, can cause hypoglycemia by producing
and secreting insulin-like paraneoplastic substances such as IGF-2 that bind to and activate the insulin receptor. With high morbidity
and mortality rates within tumor HI, there remains a significant unmet need for new therapies directed at hypoglycemia treatment. Ersodetug
has shown real-world benefit in patients with insulinoma and preclinical studies have shown that ersodetug can similarly blunt IGF-2 and
insulin-mediated insulin-receptor signaling.
About Rezolute, Inc.
Rezolute is a late-stage rare disease company
focused on significantly improving outcomes for individuals with hypoglycemia caused by HI. The Company’s antibody therapy,
ersodetug, is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment
of congenital HI and tumor HI.
Forward-Looking Statements
Any statements in this press release about the
Company’s future expectations, plans and prospects, including statements regarding the public offering, constitute forward-looking
statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements
include any statements about the Company’s strategy, future operations and future expectations and plans and prospects for the Company,
and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,”
“intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,”
“target,” “potential,” “will,” “would,” “could,” “should,” “continue,”
and similar expressions. These forward-looking statements include statements about the RZ358 Expanded Access Program, the Investigational
New Drug (IND) application for RZ358, the ability of the U.S. Ersodetug to become an effective treatment for congenital hyperinsulinism,
the effectiveness or future effectiveness of the U.S. Ersodetug to become an effective treatment for congenital hyperinsulinism, and statements
regarding clinical trial timelines for RZ358. These forward-looking statements are based on information currently available to the Company
and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current
plans. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs,
future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements.
Such risks and uncertainties include, among others, those related to market and other financial conditions, the potential completion of
the public offering, satisfaction of customary closing conditions related to the public offering and other factors discussed in the “Risk
Factors” section contained in the preliminary prospectus supplement and the reports that the Company files with the SEC. Any forward-looking
statements represent the Company’s views only as of the date of this press release. The Company anticipates that subsequent events
and developments will cause its views to change. While the Company may elect to update these forward-looking statements at some point
in the future, the Company specifically disclaims any obligation to do so except as required by law.
Contacts:
Rezolute, Inc.
Christen Baglaneas
cbaglaneas@rezolutebio.com
508-272-6717
LHA Investor Relations
Tirth T. Patel
tpatel@lhai.com
212-201-6614
Exhibit 99.2
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img001.jpg)
| Late-stage Rare Disease Company
Treating Hyperinsulinism
Corporate Presentation
NASDAQ: RZLT |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img002.jpg)
| Forward Looking Statements
| 2
This presentation, like many written and oral communications presented by Rezolute and our authorized officers, may contain
certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of
the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking
statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking
statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are
generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "prove,"
"potential," "seek," "strive," "try," or future or conditional verbs such as "predict," "could," "may," "likely," "should," "will,"
"would," or similar expressions. These Forward-Looking statements include, but are not limited to, statements regarding the
sunRIZE clinical study, the RIZE study, the Investigational New Drug (IND) application for RZ358 (Ersodetug), the ability of RZ358 to
become an effective treatment, the effectiveness or future effectiveness of RZ358 as a treatment, statements regarding clinical
trial timelines for the treatment. Our ability to predict results or the actual effects of our plans or strategies is inherently
uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law
or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances
that occur after the date on which such statements were made. Important factors that may cause such a difference include any
other factors discussed in our filings with the SEC, including the Risk Factors contained in the Rezolute’s Annual Report on Form
10-K and Quarterly Reports on Form 10-Q, which are available at the SEC’s website at www.sec.gov. You are urged to consider
these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance
on such forward-looking statements, which are qualified in their entirety by this cautionary statement. This presentation shall not
constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other
jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws
of any such state or other jurisdiction. |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img003.jpg)
| Seasoned
management team
with demonstrated
success from early
development
through
commercialization
Each program is a
potential >$1B+
market opportunity
with additional
upside with market
expansion
Compelling real-world evidence of
patient benefit
under the
Company’s
Expanded Access
Program
Two rare disease
Phase 3 programs
evaluating
ersodetug to treat
hypoglycemia in
congenital HI and
tumor HI
RZ358 (ersodetug) is
a fully human
monoclonal
antibody designed
to treat
hypoglycemia
caused by all forms
of hyperinsulinism
(HI)
Rare Disease Company Treating Hyperinsulinism
| 3 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img004.jpg)
| Management Team
| 4
Nevan Charles Elam
Founder & Chief Executive Officer
Brian Roberts
Chief Medical Officer
Daron Evans
Chief Financial Officer
Susan Stewart
Chief Regulatory Officer
Michael Deperro
SVP, Corporate Development |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img005.jpg)
| Program Target IND-Enabling Phase 1 Phase 2 Phase 3 Next
Milestone
Milestone
Expected
RZ358
(ersodetug)
Congenital
Hyperinsulinism
(cHI)
Topline data Mid-2025
RZ358
(ersodetug)
Tumor
Hyperinsulinism
(tHI)
Patient
enrollment in
Phase 3 study
1H 2025
Two Phase 3 Rare Disease Indications Targeting Hyperinsulinism
| 5 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img006.jpg)
| RZ358
Treatment for Hyperinsulinism (HI)
Ersodetug |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img007.jpg)
| GLUT4
INSULIN or IGF-2 GLUCOSE
RZ358
Reduces
Signaling
Increases
Available Blood
Glucose
GLUT4: glucose transporter type 4. | 7
o Ersodetug allosterically binds to the insulin
receptor to modulate the signaling effect
of insulin and IGF-2 to maintain glucose
values in a healthy range
o Novel mechanism operates downstream to
counteract excess insulin receptor
activation
o Administered by IV infusion every 2 to 4
weeks Reduces
Glucose
Uptake
Antibody Designed to Treat All Forms of HI |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img008.jpg)
| Rare disease caused by tumors that
produce insulin or insulin-like
substances such as IGF-2
Rare pediatric genetic disease
characterized by excessive insulin
production
Hypoglycemia as a Result of HI
congenital HI (cHI) tumor HI (tHI)
Ersodetug has shown substantial benefit in studies and real-world use for treatment of cHI and tHI
| 8
Hypoglycemia
o Severe, persistent, life-threatening complication of
over activation of the insulin receptor
o Consequence of multiple forms of HI
o Lack of effective treatment options |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img009.jpg)
| Congenital HI Congenital HI |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img010.jpg)
| o ~2000 individuals in the U.S. that would be candidates to use ersodetug
• 1 in 28,000 live births in the US
• 25 years of treatment required on average
• ~3500 cases in the US
• Often presents within first month of life
o Most common cause of persistent hypoglycemia in infants and children
o Symptoms often not recognized until life-threatening
o Risk of coma, death, and other serious complications
o 50% of children have neurological deficiencies
o No therapy has been developed and approved for chronic treatment
Disease Background
| 10 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img011.jpg)
| o Diazoxide (DZ) is the current standard of care and only approved treatment for hypoglycemia
caused by HI
o 50% of patients do not respond to DZ
o May experience frequent and serious adverse reactions
• FDA black box for pulmonary hypertension
o Patients report1 intolerable side effects and would welcome an alternative treatment option
• Increased body hair (85%)
• Loss of appetite (36%)
• Swelling (25%)
• Stomach pain/upset stomach (23%)
• Facial changes (22%)
Standard of Care for HI is Inadequate
Source: 1) HI Global Registry 2022 Annual Report: 165 patients surveyed, 134 have taken DZ. | 11 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img012.jpg)
| Marginal efficacy, effects wane with repeat dosing
Gastrointestinal side effects
Risk of necrotizing enterocolits, particularly in newborns
Potential interaction with pituitary hormones (growth and
thyroid)
Glucagon
Current formulations short-acting
Temporary measure for emergent glucose correction
Repeated use may deplete liver glucose stores
Long-term efficacy is modest
Somatostatin
Analogues (SSAs)
Pancreatectomy
Invasive procedure, not done globally
Hypoglycemia may persist for years in up to half of patients
Requires adjuvant medical management, and/or repeat surgery
Eventually insulin therapy required
Resection for diffuse disease
[Off label]
Resection for focal disease
Limited number of overall cases
Only done at specialized centers
Can be curative for patients
Frequent, glucose-enriched oral feeds or continuous enteral tube feeds
Multifactorial feeding aversions affect a large proportion of children with cHI
Negative impact on normal daily activities and social interactions
Carbohydrate
Supplementation
Other Available Treatment Options are Suboptimal
| 12 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img013.jpg)
| o 23 participants
• Average age ~6.5 (16 participants were between 2-6 years of age)
• Diverse group across gender and genetics
o ~20% average daily time in hypoglycemia and 13 hypoglycemia events per week at baseline
• Participants were on SOC
o Generally safe and well-tolerated
• No adverse drug reactions
• No study terminations
• No clinically-significant hyperglycemia or hyperglycemia AEs
o Study exceeded expectations for glucose correction:
• Improvement in time in hypoglycemia and overall events of up to ~90% at top doses
• Nearly universal response rate at the top dose
o Predictable and dose-dependent pharmacokinetics
SOC: standard of care. AEs: adverse events. | 13
Phase 2b RIZE Study Results |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img014.jpg)
| Baseline End of Treatment
0
5
10
15
Time by CGM [N=15∧]
% Time
(Median)
-61%
p < 0.0005
Baseline End of Treatment
0
5
10
15
Event Rate by BGM (N=15∧)
Events Per Week
(Median)
p < 0.0005
- 74%
Hypoglycemia (<70 mg/dL) Severe Hypoglycemia (<50 mg/dL)
Baseline End of Treatment
0
1
2
3
4
Time by CGM [N=15∧]
% Time
(Median)
-76%
p< 0.05
Baseline End of Treatment
0
1
2
3
4
Event Rate by BGM (N=15∧)
Events Per Week
(Median)
p < 0.001
- 89%
BGM: blood glucose monitoring. CGM: continuous glucose monitoring. One 9 mg/kg participant excluded from analyses for stopping background therapy while on study; two others wore CGM
incorrectly which impacted efficacy by CGM but were included in analyses.
| 14
Substantial Improvement in All Hypoglycemia Metrics
Improvement in time in hypoglycemia and overall events of ~75% and up to ~90% at top doses
Pooled 6 and 9 mg/kg dose levels representative of Phase 3 population and dosing |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img015.jpg)
| | 15
2-Year-Old
on SSA
6-Year-Old;
Failed meds,
pancreatectomy
Average Daily Time in Hypoglycemia ~40%
Average Daily Time in Hypoglycemia ~45%
Baseline CGM period (≥10 days) Treatment Evaluable CGM (2-weeks)
RZ358 9 mg/kg
On Treatment RZ358 6 mg/kg
On Treatment
Baseline End of Treatment
0
10
20
30
40
50
% Time
Hypoglycemia
93% Improvement
SSA: Somatostatin Analog. CGM: continuous glucose monitoring.
Compelling Patient Responses
Nearly universal patient response rate (>50% hypoglycemia correction) observed at mid and top doses |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img016.jpg)
| o Multi-center, double-blind, randomized, controlled, safety and efficacy registrational study
o Patient population (n=56)
• Ages 3 months and above who have not achieved adequate glycemic control with standard of care
medical management
o Primary endpoint: change in average hypoglycemia events per week
• Secondary endpoints include change in average daily percent time in hypoglycemia, change in severe
hypoglycemia events and time, time in a target glucose range, and symptomatic hypoglycemia events
o Pivotal treatment arms
• ~48 participants ages 1 year and above randomized in double blind, placebo-controlled fashion
• Three bi-weekly loading doses, then 4 monthly doses over a total 6-month treatment period
• 5 mg/kg (+ SOC) (n = 16)
• 10 mg/kg (+ SOC) (n = 16)
• Placebo (SOC only) (n = 16)
• Open label treatment arm: ~8 participants ages 3 months to 1 year
• Eligible participants may continue in a long-term extension study following pivotal treatment
o Topline results expected mid-2025
| 16
Phase 3: The sunRIZE Study
SOC: standard of care. |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img017.jpg)
| Immediately Addressable U.S. Market
| 17
Diazoxide (DZ)
(up to 15 mg/kg/day)
Unacceptable
Side Effects
Tolerated
Focal
Diffuse
After ~5-Day
DZ Use:
~30% (420 pts)
~75% (1575 pts)
40%
60%
Responsive
Unresponsive
~3,500 Diagnosed
cHI Patients in US*
~25% (525 pts)
~70% (980 pts)
Addressable population of
~2,000
with an average
treatment duration of
25+ years
Diagnosis and Treatment Pathway Illustrates that ~2,000 Individuals are Addressable
HI: hyperinsulinism. DZ: Diazoxide. DZR: Diazoxide Responsive. DZNR: Diazoxide Non-Responsive (kATP channel defect). *Similar numbers in EU |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img018.jpg)
| o ~10K individuals in primary markets
• 1 in 28,000 live births and up to 1 in 2,500 live births in certain populations due to consanguinity
• In addressable patient population, disease persists for more than 25 years on average
o At Launch >50% of the market is addressable
• <50% of patients are adequately managed by standard of care
• Growing percentage of patients on standard of care experience unacceptable side effects
o Rapid patient identification and concentrated prescriber base enables accelerated adoption
• 60% of patients are diagnosed within 1 month of presentation
• 80% of patients are managed at centers of excellence that are participating the Phase 3 clinical trial
o Regulatory Designations: Orphan, Pediatric Rare Disease (FDA), PRIME (EMA), ILAP (UK)
o Potential for expanded indications such as tumor HI
HI: hyperinsulinism. | 18
Addressable Worldwide Market
$1B+ market opportunity with rare disease pediatric disease drug pricing |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img019.jpg)
| Tumor HI |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img020.jpg)
| o ~1,500 immediately addressable individuals with severe, refractory hypoglycemia in the U.S.
o Hypoglycemia caused by two distinct tumor types:
• Islet Cell Tumors (ICT)
• Excessive secretion of insulin
• Malignant insulinomas are the most common ICTs that cause hypoglycemia
• Non-Islet Cell Tumors (NICT)
• Produce and secrete insulin-like substances such as IGF-2 that over-activate the insulin receptor
• Hepatocellular carcinomas (HCC) are the most common NICTs that cause hypoglycemia
o Significant unmet need across both tumor types
• Resulting hypoglycemia is often severe and may have serious adverse outcomes
• Limited treatment options with poor efficacy and safety profiles
• High morbidity and mortality rates
• Can require hospitalization (often prolonged and in ICU) and interferes with patient quality of life
• May prevent adjuvant tumor treatment
Disease Background
| 20 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img021.jpg)
| o Tumor-directed therapies do not directly treat hypoglycemia
• Adequate hypoglycemia management is required prior to initiation of tumor-targeted therapies
o Therapies to treat malignant insulinoma are often ineffective or poorly tolerated
• Diazoxide (DZ) is the only approved treatment
• Suboptimal response rates and serious side effects
• Somatostatin analogs (SSAs)
• Used off-label with limited success
• May worsen hypoglycemia in tumor HI setting
• mTOR-inhibitors
• Used off-label and have potentially severe side effects
o Limited and often ineffective treatment options for hepatocellular carcinoma (HCC)
• Medical therapies directed at suppressing insulin secretion such as DZ and SSAs do not work in non-islet cell
tumors (NICTs) where HI is caused by non-insulin substances such as IGF-2
Treatment Options and Unmet Need
| 21 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img022.jpg)
| o Multiple ICT patients with severe refractory hypoglycemia
• Hospitalized and in life-threatening or hospice-bound condition
• Required continuous high volume/concentration intravenous
dextrose or nutritional infusion
• Tumor-directed therapies (e.g., embolization, radiotherapy,
chemotherapy) deferred because of hypoglycemia
• Physician-requested use of ersodetug
o Administration of ersodetug resulted in:
• Substantial hypoglycemia improvement with no significant side
effects
• Discontinuation of intravenous dextrose
• Discharge from in-patient to out-patient care
• Resumption of tumor-directed therapies
Real-world Patient Benefit Under EAP
EAP: Expanded Access Program. Sources: n engl j med 389;8 Aug24,2023 - | 22
https://www.nejm.org/doi/full/10.1056/NEJMc2307576?query=TOC&cid=NEJM+eToc%2C+August+24%2C+2023+DM2279684_NEJM_Non_Subscriber&bid=1754093795 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img023.jpg)
| Phase 3 Study Overview
o Multi-center, double-blind, randomized, controlled, safety and efficacy registrational study
o Patient population (n= up to 48)
• Adult ICT and NICT patients with HI who have not achieved adequate hypoglycemia control with SOC therapies
• 24 participants in double-blind, placebo-controlled arm (to evaluate primary endpoint/hypoglycemia events)
• Up to 24 participants in open label arm: initial 6 NICT patients and any hospitalized participants on IV glucose
o Primary endpoint: change in average hypoglycemia events per week by self-monitored blood glucose
• Secondary/additional endpoints: change in average daily percent time in hypoglycemia, change in Level 1
hypoglycemia events and time, hospitalization, patient reported quality of life
• Open-label arm to evaluate change in IV glucose requirements in hospitalized participants
o Treatment arms and dosing regimen
• Once weekly administration over 6-week pivotal treatment period
• 9 mg/kg RZ358 (+ SOC) (n = 12)
• Matched placebo (SOC only) (n = 12)
• 9 mg/kg RZ358 Open Label Arm (n ≤ 24)
• Eligible participants may continue in a long-term extension study following pivotal treatment
o IND filed and cleared: start-up activities in progress to enable patient enrollment in 1H 2025
ICT: islet-cell tumor. NICT: non-islet cell tumor. SOC: standard of care. | 23 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img024.jpg)
| Immediately Addressable U.S. ICT Market
| 24
~300 pts
~30%
~25% ~1,5002 patients
~500 Addressable
Patients with
Severe/Refractory
Hypoglycemia
Malignant Insulinoma Hypoglycemia (Hypo) Diagnosis and Treatment Pathway1
ICT: islet cell tumor. Source: 1) Based on analysis of seven years of data from the Komodo Claims Assessment; 2) Approximate, average prevalence of patient with both malignant insulinoma and
diagnosed hypoglycemia.
Medical
Management
for Hypo
Mild Hypo
(No
treatment)
80%
20%
De-bulking
Surgery
Hypo Not
Adequately
Managed
Hypo
Adequately
Managed
~45%
Refractory
Hypo, Post-Sugery
No Further
Treatment
Provided
~40%
~60%
~215 pts |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img025.jpg)
| Immediately Addressable U.S. NICT Market
| 25
~560 pts
~45%
~25% ~4,5002 patients
~1,000 Addressable
Patients with
Severe/Refractory
Hypoglycemia
Hepatocellular Carcinoma + Hypoglycemia (Hypo) Diagnosis and Treatment Pathway1
NICT: non-islet cell tumor. Source: 1) Based on analysis of seven years of data from the Komodo Claims Assessment; 2) Approximate, average prevalence of patient with both malignant insulinoma and
diagnosed hypoglycemia
Medical
Management
for Hypo
Mild Hypo
(No
treatment)
50%
50%
De-bulking
Surgery
Hypo Not
Adequately
Managed
Hypo
Adequately
Managed
~30%
Refractory
Hypo, Post-Sugery
No Further
Treatment
Provided
~40%
~60%
~405 pts |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_ex99-2img026.jpg)
| Each program has a
potential >$1B+
market opportunity
with upside
potential
Compelling real-world evidence of
patient benefit
under the
Company’s
Expanded Access
Program
RZ358 (ersodetug) is
a fully human
monoclonal
antibody designed
to treat
hypoglycemia
caused by all forms
of HI
Mission-driven to
improve outcomes
for individuals with
severe hypoglycemia
caused by
hyperinsulinism (HI)
Rare Disease Company Treating Hyperinsulinism
| 26
Strong Balance Sheet; cash runway through Q2 2026 |
v3.24.2.u1
Cover
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Aug. 05, 2024 |
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