On this page of StockholderLetter.com we present the latest annual shareholder letter from INOVIO PHARMACEUTICALS, INC. — ticker symbol INO. Reading current and past INO letters to shareholders can bring important insights into the investment thesis.
TO OUR STAKEHOLDERS
As we reflect on 2024 and look ahead to 2025, I am very pleased to share some highlights of the considerable
progress INOVIO has made and our plans for the potentially transformational year that lies ahead. We are
on the cusp of bringing our first product candidate to market, which would also be the first DNA medicine
available in the US. Our aim is to enable a potentially life-changing solution for patients suffering from recurrent
respiratory papillomatosis (RRP), a devastating, chronic, and rare disease of the respiratory tract. To achieve
this goal, we remain focused on our strategic priorities and are energized by our commitment to patients, who
are at the heart of everything we do.
In 2025, we have three key goals:
1
Submit our Biologics License Application (BLA) for INO-3107
Our primary focus is to complete the submission of our BLA in the second half of 2025, with a goal of receiving
FDA acceptance of the file by the end of the year. To achieve this, we anticipate completing the device verification
testing in the first half of 2025 and requesting rolling submission from the FDA. If granted, we plan to begin the
rolling submission process in mid-2025 and request priority review. We have completed the drafting of all non-device
related modules for the BLA and are focused on completing the device-related modules as quickly as possible.
2
Advance Commercial Preparations
The potential approval of INO-3107 is not only a major proof point for our technology platform, it also offers
the opportunity to generate meaningful revenues to enable the further development of other promising DNA
medicines in our pipeline. To maximize this opportunity, we aim to continue advancing our commercial plans in
2025 to be prepared for a fast and efficient launch if we receive approval. Our efforts are guided by our market
research indicating that INO-3107 has the potential to become the preferred treatment option for RRP based
on the efficacy and tolerability results we have observed to date, as well as INO-3107   s simple, patient-centric
treatment regimen that recognizes that every surgery matters to patients.
3
Progress our Diversified Pipeline
While energized by the significant progress for our lead candidate, we are continuing to leverage the strengths
of our platform and driving progress across our pipeline through collaborations and other potential strategic
opportunities. For INO-3112, we are advancing plans for a Phase 3 study in combination with LOQTORZI  
(toripalimab-tpzi) in patients with locoregionally advanced, high-risk, HPV16/18-positive oropharyngeal squamous
cell carcinoma. For INO-5401 for GBM, following promising data in our Phase 1/2 trial, we are developing a design
for a controlled Phase 2 trial in combination with a PD-1 inhibitor. We are also advancing the next generation of
DNA medicine by building on the promising proof-of-concept Phase 1 data we recently announced for our
DNA-encoded Monoclonal Antibody (DMAbTM) technology.
We are excited about the work ahead and the tremendous opportunity to deliver
on the power and potential of DNA medicine for patients and shareholders alike.
Thank you for your continued support and commitment to INOVIO   s mission.
Dr. Jacqueline Shea, President and CEO
2024 IN REVIEW
Significant Progress for Lead Candidate INO-3107 for RRP
2020


Authorization
to begin Ph 1/2
clinical trial (US;
RRP-001)
Orphan Drug
Designation (US)
2022

Positive results
from 1st cohort
of Ph 1/2 trial
announced
(RRP-001)

Positive results
from 2nd cohort
of Ph 1/2 trial
announced
(RRP-001)

Orphan Drug
Designation (EU)

Breakthrough
Therapy
Designation (US)

INOVIO informed
can submit
BLA under
FDA Accelerated
Approval Pathway
2025 GOALS
2024
2023

Innovation Passport
Designation (UK)

ATMP Certification (EU)




Complete device
verification (DV)
process for array
and device
Pre-BLA Meeting (US)

Testing as part of BLA req   s
found low-level breakage
of plastic molded part of
disposable single-use array
Submit IND to initiate
confirmatory trial

Submit BLA (will
request rolling
submission and
priority review)

Prepare for
commercial launch
Immunology data from
RRP-001 presented
Durability data from
retrospective study
(RRP-002) announced
Advanced Other Key Candidates
INO-3112: Signed clinical collaboration and supply
agreement with Coherus BioSciences, Inc. Gained
alignment with the FDA on the planned Phase 3 trial
design and received initial feedback from European
regulatory authorities on proposed trial design.
DMABs: Announced top-line interim results from
an ongoing Phase 1 trial in March 2025 providing
the first clinical proof-of-concept that DMAbs can be
durably expressed in humans. This next-gen DNA
medicine has the potential to overcome challenges
with traditional monoclonal antibodies and transform
treatments for a broad range of diseases.
Welcomed Steven Egge,
Chief Commercial Officer
Steve joined INOVIO in July 2024,
bringing extensive commercial launch
and broad therapeutic area experience.
INO-4201: Advanced development plans for a
Phase 2 trial for INO-4201 as a potential booster to
ERVEBO   (rVSV-ZEBOV).
INO-5401: Continued efforts to move INO-5401
into its next stage of development for glioblastoma,
which we believe will be a controlled Phase 2
trial. Additionally, our partners at the University of
Pennsylvania continued to advance a Phase 1 trial of
INO-5401 exploring the potential to prevent cancer in
people with BRCA1 or BRCA2 mutations.
APRIL 2025
 • shareholder letter icon 4/7/2025 Letter Continued (Full PDF)
 • stockholder letter icon 3/28/2023 INO Stockholder Letter
 • stockholder letter icon 4/15/2024 INO Stockholder Letter
 • stockholder letter icon More "Miscellaneous" Category Stockholder Letters
 • Benford's Law Stocks icon INO Benford's Law Stock Score = 79


INO Shareholder/Stockholder Letter Transcript:

TO OUR STAKEHOLDERS
As we reflect on 2024 and look ahead to 2025, I am very pleased to share some highlights of the considerable
progress INOVIO has made and our plans for the potentially transformational year that lies ahead. We are
on the cusp of bringing our first product candidate to market, which would also be the first DNA medicine
available in the US. Our aim is to enable a potentially life-changing solution for patients suffering from recurrent
respiratory papillomatosis (RRP), a devastating, chronic, and rare disease of the respiratory tract. To achieve
this goal, we remain focused on our strategic priorities and are energized by our commitment to patients, who
are at the heart of everything we do.
In 2025, we have three key goals:
1
Submit our Biologics License Application (BLA) for INO-3107
Our primary focus is to complete the submission of our BLA in the second half of 2025, with a goal of receiving
FDA acceptance of the file by the end of the year. To achieve this, we anticipate completing the device verification
testing in the first half of 2025 and requesting rolling submission from the FDA. If granted, we plan to begin the
rolling submission process in mid-2025 and request priority review. We have completed the drafting of all non-device
related modules for the BLA and are focused on completing the device-related modules as quickly as possible.
2
Advance Commercial Preparations
The potential approval of INO-3107 is not only a major proof point for our technology platform, it also offers
the opportunity to generate meaningful revenues to enable the further development of other promising DNA
medicines in our pipeline. To maximize this opportunity, we aim to continue advancing our commercial plans in
2025 to be prepared for a fast and efficient launch if we receive approval. Our efforts are guided by our market
research indicating that INO-3107 has the potential to become the preferred treatment option for RRP based
on the efficacy and tolerability results we have observed to date, as well as INO-3107   s simple, patient-centric
treatment regimen that recognizes that every surgery matters to patients.
3
Progress our Diversified Pipeline
While energized by the significant progress for our lead candidate, we are continuing to leverage the strengths
of our platform and driving progress across our pipeline through collaborations and other potential strategic
opportunities. For INO-3112, we are advancing plans for a Phase 3 study in combination with LOQTORZI  
(toripalimab-tpzi) in patients with locoregionally advanced, high-risk, HPV16/18-positive oropharyngeal squamous
cell carcinoma. For INO-5401 for GBM, following promising data in our Phase 1/2 trial, we are developing a design
for a controlled Phase 2 trial in combination with a PD-1 inhibitor. We are also advancing the next generation of
DNA medicine by building on the promising proof-of-concept Phase 1 data we recently announced for our
DNA-encoded Monoclonal Antibody (DMAbTM) technology.
We are excited about the work ahead and the tremendous opportunity to deliver
on the power and potential of DNA medicine for patients and shareholders alike.
Thank you for your continued support and commitment to INOVIO   s mission.
Dr. Jacqueline Shea, President and CEO

2024 IN REVIEW
Significant Progress for Lead Candidate INO-3107 for RRP
2020


Authorization
to begin Ph 1/2
clinical trial (US;
RRP-001)
Orphan Drug
Designation (US)
2022

Positive results
from 1st cohort
of Ph 1/2 trial
announced
(RRP-001)

Positive results
from 2nd cohort
of Ph 1/2 trial
announced
(RRP-001)

Orphan Drug
Designation (EU)

Breakthrough
Therapy
Designation (US)

INOVIO informed
can submit
BLA under
FDA Accelerated
Approval Pathway
2025 GOALS
2024
2023

Innovation Passport
Designation (UK)

ATMP Certification (EU)




Complete device
verification (DV)
process for array
and device
Pre-BLA Meeting (US)

Testing as part of BLA req   s
found low-level breakage
of plastic molded part of
disposable single-use array
Submit IND to initiate
confirmatory trial

Submit BLA (will
request rolling
submission and
priority review)

Prepare for
commercial launch
Immunology data from
RRP-001 presented
Durability data from
retrospective study
(RRP-002) announced
Advanced Other Key Candidates
INO-3112: Signed clinical collaboration and supply
agreement with Coherus BioSciences, Inc. Gained
alignment with the FDA on the planned Phase 3 trial
design and received initial feedback from European
regulatory authorities on proposed trial design.
DMABs: Announced top-line interim results from
an ongoing Phase 1 trial in March 2025 providing
the first clinical proof-of-concept that DMAbs can be
durably expressed in humans. This next-gen DNA
medicine has the potential to overcome challenges
with traditional monoclonal antibodies and transform
treatments for a broad range of diseases.
Welcomed Steven Egge,
Chief Commercial Officer
Steve joined INOVIO in July 2024,
bringing extensive commercial launch
and broad therapeutic area experience.
INO-4201: Advanced development plans for a
Phase 2 trial for INO-4201 as a potential booster to
ERVEBO   (rVSV-ZEBOV).
INO-5401: Continued efforts to move INO-5401
into its next stage of development for glioblastoma,
which we believe will be a controlled Phase 2
trial. Additionally, our partners at the University of
Pennsylvania continued to advance a Phase 1 trial of
INO-5401 exploring the potential to prevent cancer in
people with BRCA1 or BRCA2 mutations.
APRIL 2025



shareholder letter icon 4/7/2025 Letter Continued (Full PDF)
 

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