TOEGEPASTE GENETISCHE TECHNOLOGIES CORP MANAGEMENT BESPREKING EN ANALYSE VAN DE FINANCILE STAAT EN RESULTATEN VAN DE ACTIVITEITEN (formulier 10-K)

The following discussion and analysis of our financial condition and results of
operations should be read in conjunction with the financial statements and notes
included in Part IV, Item 15 of this Annual Report on
Form 10-K.
In addition to historical financial information, the following discussion
contains forward-looking statements that reflect our plans, estimates and
beliefs. Our actual results could differ materially from those

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besproken in de toekomstgerichte verklaringen. Factoren die deze verschillen kunnen veroorzaken of ertoe kunnen bijdragen, zijn onder meer de factoren die hieronder en elders in dit jaarverslag worden besproken, met inbegrip van, maar niet beperkt tot, de factoren die zijn uiteengezet in „Waarschuwing met betrekking tot toekomstgerichte verklaringen“ en „Risicofactoren“.

Overzicht


We are a clinical-stage biotechnology company that uses our proprietary gene
therapy platform technology to develop transformational genetic therapies for
people suffering from rare and debilitating diseases. Our initial focus is in
the field of ophthalmology, where we have wholly owned
clinical-stage programs in X-linked retinitis pigmentosa
("XLRP") and achromatopsia ("ACHM"), and an optogenetics program through our
collaboration with Bionic Sight, Inc. (previously Bionic Sight, LLC) ("Bionic
Sight"). Our preclinical pipeline includes a program in dry
age-related macular degeneration
("dAMD"), two programs targeting central nervous system ("CNS") disorders,
including frontotemporal dementia ("FTD") and amyotrophic lateral sclerosis
("ALS"), and a program in otology through our collaboration with Otonomy, Inc.
("Otonomy"). In May 2022, we released interim, masked, clinical data from the
Skyline trial (as defined below) in our XLRP program and we now have
24-month
data from the XLRP Phase 1/2 trial ("Horizon"). In addition to our product
pipeline, we have also developed broad technological and manufacturing
capabilities, utilizing our internal scientific resources and collaborating with
others.

Since our inception, we have devoted substantially all of our resources to the
development of our clinical and preclinical programs in ophthalmology, otology
and CNS, including manufacturing product candidates in compliance with good
manufacturing practices, preparing to conduct and conducting clinical trials of
our product candidates, providing general and administrative support for these
operations and protecting our intellectual property. We do not have any products
approved for sale and have not generated any revenue from product sales. To
date, we have funded our operations primarily through public offerings of our
common stock and warrants to purchase our common stock, private placements of
our preferred stock, collateralized borrowing and collaborations. We have also
been the recipient, either independently or with our collaborators, of grant
funding administered through federal, state, and local governments and agencies
and by patient advocacy groups such as The Foundation Fighting Blindness.

We have incurred losses from operations in each year since inception, except for
fiscal year 2017, wherein we reported net income of $0.4 million due, in part,
to profits from a collaboration agreement that was ultimately terminated in
March 2019. For the years ended June 30, 2022 and 2021, we reported net losses
of $68.9 million and $57.8 million, respectively. Substantially all our net
losses resulted from costs incurred in connection with our research and
development programs and general and administrative and other expenses
associated with our operations. We expect to continue to incur significant
operating expenses in connection with our ongoing activities as we, subject to
the availability of additional funding:

• klinische proeven blijven uitvoeren voor ons XLRP- en ACHM-product

          candidates;



     •    manufacture clinical trial materials and develop larger-scale
          manufacturing capabilities, including the lease of our new
          build-to-suit
          manufacturing and quality control facility;


• ons gentherapieplatform blijven ontwikkelen en onze pijplijn uitbreiden met:

          investing in our preclinical product candidates, including those for:



  •   additional orphan and
      non-orphan
      ophthalmology indications, such as dAMD and other retinal diseases; and



  •   other inherited diseases in CNS and otology;



  •   seek regulatory approval for our product candidates;



     •    add personnel to support our scientific, collaboration and product
          development efforts; and



  •   continue to operate as a public company.



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As of June 30, 2022, we had cash and cash equivalents totaling $46.4 million. We
do not expect to generate revenue from product sales unless and until we
successfully complete development of and obtain regulatory approval for one or
more of our product candidates, which we expect will take a number of years and
which we believe is subject to significant uncertainty. We believe that our
available cash and cash equivalents, along with net proceeds of approximately
$9.0 million from an underwritten public offering of our common stock, together
with accompanying warrants, which is described in Note 15 to our financial
statements in this Annual Report on Form
10-K,
will be sufficient to allow us to generate data from our ongoing and planned
clinical programs and fund currently planned research and discovery programs
through calendar year 2022. We will require substantial additional funding to
continue our XLRP Phase 2/3 ("Vista") trial, move our ACHMB3 product candidate
forward, obtain regulatory approval for our lead product candidates, build the
sales, marketing and distribution infrastructure that we believe will be
necessary to commercialize our lead product candidates, if approved, and execute
our plan to open and operate a leased current Good Manufacturing Practices
("cGMP") manufacturing and quality control facility. However, our current
operating plan may change as a result of many factors currently unknown to us,
and we may need to seek additional funds sooner than planned, through various
strategic transactions, including a merger, public or private equity or debt
financings, government or other third-party funding, or a combination of these
approaches. We may be unable to enter into such other arrangements or raise
additional funds when needed on favorable terms, or at all. Our failure to enter
into such other arrangements or raise capital as and when needed would have a
negative impact on our financial condition and our ability to develop our
product candidates and continue our research and development efforts.

Programma-updates en recente ontwikkelingen

AGTC-501

voor de behandeling van XLRP

AGTC-501,

our lead gene therapy development program for the treatment of XLRP, is designed
to use an engineered adeno-associated virus ("AAV") vector to insert a
stabilized and functional copy of the Retinitis Pigmentosa GTPase Regulator
("RPGR") gene into a patient's photoreceptor cells.
AGTC-501
is comprised of a stabilized RPGR gene and a promoter that was specifically
selected to drive efficient gene expression in primate rods and cones, maintain
photoreceptor function and delay disease progression in preclinical models of
disease. In addition, published
non-human
primate studies showed that our proprietary AAV capsid had as much as twice the
transfection efficiency in photoreceptors when compared to capsids used in
competing programs.

We are currently conducting multiple clinical trials of
AGTC-501
that are intended to support the potential submission of a Biologics License
Application ("BLA"), including a Phase 1/2 trial, Horizon, which incorporates an
expansion portion that we refer to as the Skyline trial. The
24-month
data from our Horizon trial show
AGTC-501
continues to demonstrate a favorable safety profile and is well tolerated by
patients. No serious adverse events related to
AGTC-501
have been reported through month 24. In addition to safety, Horizon is
evaluating biologic activity by assessing changes in several measures of visual
function. There were clinically meaningful improvements in visual sensitivity,
as measured by microperimetry, that continued through 24 months after treatment
in centrally treated patients. Specifically, a clinically significant treatment
effect in visual sensitivity was seen and sustained 24 months after treatment
when comparing treated eyes to fellow untreated eyes in this trial and
improvements in visual sensitivity continue to correlate with improvements in
retinal structure 24 months after treatment. In addition, improvements in best
corrected visual acuity seen 12 months after treatment continue to show evidence
of a biological response 24 months after treatment. Collectively, these clinical
data are encouraging and continue to inform our clinical development in patients
with XLRP.

The Skyline trial is a 14 patient multi-site, Phase 2 trial in which patients
are randomized to either a high dose of
AGTC-501
(the dose received by patients in Group 5 of Horizon), or a low dose of
AGTC-501
(the dose received by patients in Group 2 of Horizon). The primary endpoint in
the Skyline trial is the proportion of treated eyes with an improvement of 7
decibels ("dB") or greater in visual sensitivity from baseline in at least 5
loci at 12 months as measured by microperimetry. Secondary endpoints include the
proportion of treated eyes with improvements in best corrected visual acuity at
twelve months, a patient's ability to navigate a mobility maze

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more successfully under varying light and challenge conditions at 12 months, and
improvements in retinal structure at twelve months. The Skyline trial is masked
in that we, the patients and the sites do not know which patient is in which
dose group or which dose group received the high or low dose. Accordingly, we
refer to the two groups as Dose Group A and Dose Group B. We completed
enrollment in the Skyline trial in the first quarter of calendar year 2022 and
reported
3-month
interim results for 13 of the 14 enrolled patients in May 2022. Safety, visual
sensitivity, visual acuity and the mobility maze were the only endpoints
evaluated at 3 months. Retinal structure improvements, another important
endpoint, was not evaluated as changes in retinal structure are not expected
until between 9 and 12 months.

Similar to safety results reported for Horizon, safety results to date for the
Skyline trial support that
AGTC-501
is generally well tolerated and there are no clinically significant safety
concerns. There were
non-serious
ocular adverse events (grade 2) related to the study agent that were similar
between the two dose groups and two ocular serious adverse events, including an
increase in intraocular pressure determined to be related to corticosteroids
which has resolved, and one of visual impairment deemed related to the surgical
procedure which is resolving.

Demographic and baseline characteristics were well balanced between the two dose
groups in the Skyline trial. Notably, compared to Horizon, patients in the
Skyline trial were younger, with better baseline visual sensitivity and visual
acuity.

Improvements in visual sensitivity, the primary efficacy endpoint in the Skyline
trial, were observed in both dose groups at three months. We define responders
as patients who have at least 5 loci increase by at least 7 dB. The response
rate in Dose Group A was 25% (1 of 4 patients, as one patient in this group was
unevaluable) and in Dose Group B was 62.5% (5 of 8 patients), representing a
clear difference between the two groups. Notably, while we did not observe an
increase in visual sensitivity of at least 7 dB in 5
pre-specified
loci as required based on FDA feedback, we did observe an increase in visual
sensitivity of at least 7 dB in 9 to 17 loci in the treated area. These
responders also had improvements in mean visual sensitivity across the treated
region versus the untreated eye per the repeatability coefficient.

The 13 patients in the Skyline trial had better baseline best corrected visual
acuity, a mean of 66.9 ETDRS letters on an eye chart, which correlates to a
Snellen visual acuity equivalent of approximately 20/40. Because these patients
started with better visual acuity, we believe that there was less ability for
them to improve relative to patients in the Horizon trial.

In addition, there was a correlation between visual sensitivity improvements and
trends for patients able to complete the maze more rapidly and with fewer
errors. We are working with the maze vendor on potential adjustments to account
for the fact that only one eye was treated in this analysis, whereas previous
use of the maze has been for patients treated in both eyes. It is possible that
the better visual acuity of the patients in the Skyline trial at baseline
affected the interpretation of the maze results.

De Skyline-studie heeft een vergelijkbare opzet en eindpunten als de klinische Vista-studie. We zijn van mening dat als de Vista-studie vergelijkbare resultaten heeft als de Horizon- en Skyline-studies, de hoeveelheid gegevens een BLA-indiening voor AGTC-501 zal ondersteunen.


The Vista trial is a multi-site, Phase 2/3 clinical trial expected to include
approximately 60 patients randomized across three arms: a
low-dose group (the
1.2E+11 vg/mL dose from the ongoing Horizon and Skyline trials), a high-dose
group (the 1.1E+12 vg/mL dose from the ongoing Horizon and Skyline trials) and
an untreated control group. The primary endpoint will be improvement in visual
sensitivity, defined as having at least a 7 dB increase in visual sensitivity in
at
least 5 pre-specified loci at
Month 12. Together with a third-party vendor, we have developed a machine
learning algorithm based on the available microperimetry data from our Horizon
and Skyline trials that,
on a patient-by-patient basis, predicts
the loci most likely to improve through evaluation of baseline visual
sensitivity. Secondary efficacy endpoints in the Vista trial include mean change
in visual sensitivity, improvements in visual acuity and performance on the
mobility maze as well as structural

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improvements in retinal health as measured by changes in the ellipsoid zone (the
"EZ"), a defined region within the photoreceptor layer of the retina that
degenerates over time and is eventually lost in patients with XLRP. Subject to
the availability of additional funding, we plan to complete a masked interim
analysis, with the interim data expected to be released in the first half of
calendar year 2023. We believe that the interim analysis, together with data
from Horizon, including the Skyline expansion portion, may provide us with the
opportunity to discuss with the United States Food and Drug Administration (the
"FDA") potential amendments to the Vista trial, if necessary, that may support
an earlier BLA submission than we would otherwise anticipate, or optimize the
design of the trial.

To date, we have released a significant amount of preclinical and clinical data
including improvements in visual sensitivity and visual acuity, as well as
improvements in retinal health that we believe support both the potential safety
and biological activity of
AGTC-501.
These data include the recent release of the interim data from the ongoing
Horizon and Skyline trials. Data from the ongoing Horizon trial show
improvements in visual sensitivity as measured by Macular Integrity Assessment
("MAIA") and continue to correlate with improvements in retinal structure as
measured by EZ up to 24 months after treatment. There was moderate correlation
12 months after treatment and substantial correlation 24 months after treatment.

Given the efficacy and safety data generated to date, we believe that
AGTC-501
is a potential
best-in-class product
candidate that may provide significant benefits to patients with XLRP, if
approved. Subject to the availability of additional funding and any continuing
impact of the
COVID-19
pandemic, we expect to achieve the following milestones in the XLRP development
program:

     •    provide
          12-month
          data from the Skyline expansion portion of the Horizon clinical trial in
          the first quarter of calendar year 2023; and



  •   provide interim Vista trial data in the first half of calendar year 2023.


AGTC-401
and
AGTC-402
for the Treatment of ACHM

We have been developing two gene therapy product candidates for the treatment of
ACHM. The product candidates are designed to use the same engineered AAV vector
to insert a stabilized and functional copy of the Cyclic Nucleotide Gated
Channel Subunit Beta 3 (CNGB3) gene in the case of
AGTC-401
and a stabilized and functional copy of the Cyclic Nucleotide Gated Channel
Subunit Alpha 3 (CNGA3) gene in the case of
AGTC-402.
The product candidates are designed to use the same proprietary cone-specific
promoter that was designed to maximize gene expression into a patient's
photoreceptor cells. We chose the promoter based on data from preclinical
studies that showed the promoter drove efficient gene expression in all three
types of primate cone photoreceptors and restored cone photoreceptor function in
dog, mouse and sheep models of ACHM.

We are currently conducting a Phase 1/2 clinical trial of
AGTC-401
in ACHM patients with mutations of the CNGB3 gene (ACHMB3) and a separate Phase
1/2 clinical trial of
AGTC-402
in ACHM patients with mutations of the CNGA3 gene (ACHMA3). Each Phase 1/2
clinical trial is being conducted at multiple clinical sites that specialize in
inherited retinal diseases. The primary objective of these trials is to identify
a well-tolerated dose that provides clinical benefit to patients. To date, we
have enrolled a total of 31 adult and pediatric patients into the ACHMB3 trial
of
AGTC-401
and 24 adult and pediatric patients in the ACHMA3 trial of
AGTC-402
and do not currently plan to enroll any additional patients in either trial. We
have data from a portion of the patients in these trials up to 24 months after
treatment, including our most recent release in February 2022 of
3-month
data for the two highest dose groups of ACHMB3 and ACHMA3 pediatric patients
that also included updated adult safety data. These data are consistent with the
data previously released in adult and pediatric ACHMB3 and ACHMA3 patients.

In the Phase 1/2 dose escalation study of
AGTC-401
in ACHMB3 patients, a total of 21 adults were treated over an approximately
80-fold
dose range in five groups and a total of 10 pediatric patients were treated at
the three highest dose groups. Secondary outcome measures evaluating efficacy
were assessed by standard visual function

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tests, such as perimetry. We defined two pediatric patients (17 and 7 years old)
in the 1.1E+12 vg/mL dose group as responders based on improvements in visual
sensitivity as measured by the Octopus static perimeter. Therefore, of the three
adults and four children (total n=7) in the 1.1E+12 vg/mL dose group, four
(>50%) were responders based on improvements in visual sensitivity. These
patients also reported improvements in quality of life as measured by a patient
reported outcome survey developed specifically for patients with ACHM.

The two other pediatric patients in the 1.1E+12 vg/mL dose group and three
pediatric patients ages 7 years and younger in the 3.2E+12 vg/mL dose group
(total n=5) could not sufficiently concentrate and consistently complete the
visual sensitivity testing. Similar to other trials where endpoints are adapted
for young children, we plan to work closely with clinicians and regulators to
develop potential adaptations for younger patients for visual sensitivity
testing. Despite their inability to complete the tests, we received anecdotal
feedback from certain patients that indicate improvements in visual sensitivity.
Based on the totality of data generated to date, we believe that the 1.1E+12
vg/mL dose has been well tolerated and has potential in both adult and pediatric
patients.

We also reported updated interim
3-month
pediatric data and adult and pediatric safety data for the 24 patients enrolled
in the Phase 1/2 study of
AGTC-402
targeting CNGA3 mutations in patients with ACHMA3. Data from the five pediatric
patients in the two highest dose groups were consistent with previously reported
results, indicating no evidence of clinical improvements, and do not support
further clinical development. Most patients with CNGA3 mutations express a
mutant protein that is not typically found in patients with CNGB3 mutations,
which we believe may have impacted the results seen in patients that received
AGTC-402.
We will continue to follow the ACHMA3 patients for long-term safety
observations.

As previously reported, in both the ACHMB3 and ACHMA3 trials, treatment with the
highest dose (3.2 E+12vg/ml) of
AGTC-401
and
AGTC-402,
respectively, led to three cases of severe ocular inflammation in pediatric
patients, which were reported as Suspected Unexpected Serious Adverse Reactions,
or SUSARs. No new additional SUSARs in any adult or pediatric patients have been
reported and the inflammation in all previously reported SUSARs improved with an
adjusted steroid regimen. Two SUSARs (ACHMA3) have since fully resolved and one
(ACHMB3) continues to improve, with all three patients' best corrected visual
acuity returning to baseline after initial declines in visual acuity were
observed following the SUSARs. Importantly, we have not yet observed any
comparable inflammation in any of our XLRP clinical trials.

We had a collaborative and productive End of Phase 2 ("EOP2") meeting with the
FDA to discuss the potential future development of
AGTC-401
and received constructive feedback from the FDA on our proposed primary and
secondary endpoints for a Phase 2/3 clinical trial. With respect to the primary
endpoint of improvement in visual sensitivity relative to baseline, the FDA
reiterated that a 7 dB change in at least 5
pre-specified
loci is required. However, they indicated a willingness to review an alternative
approach to perimetry from a model used in other trials, which would need to be
adapted specifically for ACHMB3. The FDA also indicated that improvements in
light discomfort may be an acceptable secondary endpoint in a Phase 2/3 clinical
trial of
AGTC-401.
We are currently working through the details of the future development plan for
AGTC-401,
but we have paused development activities due to funding constraints.

Op maat gemaakt

Productie- en kwaliteitscontrolefaciliteit in Alachua, Florida


In May 2021, we signed
a 20-year lease
(subsequently modified to 20 years and one month) for
a build-to-suit 21,250
square foot potential cGMP manufacturing and quality control facility adjacent
to our existing Florida facility to prepare for late-stage development and
potential commercialization of our XLRP and ACHMB3 programs. The facility is
also intended to provide supply chain redundancy, reduce manufacturing risk and
enhance quality controls. We anticipate that
the build-out of
the new manufacturing and quality control facility will be completed during the
fourth quarter of calendar year 2022.

Additional information regarding our new cGMP manufacturing and quality control
facility can be found in Note 3 to our financial statements in this Annual
Report on Form
10-K.

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Strategische samenwerkingen en preklinische pijplijn

Bionisch zicht


During February 2017, we entered into a strategic research and development
collaboration agreement with Bionic Sight to develop product candidates for
patients with visual deficits and blindness due to retinal disease. Through the
AGTC-Bionic Sight collaboration, the companies seek to develop a new optogenetic
therapy that leverages AGTC's deep experience in gene therapy and ophthalmology
and Bionic Sight's innovative neuro-prosthetic device and algorithm for retinal
coding. The collaboration agreement grants to us, subject to achievement by
Bionic Sight of certain development milestones, an option to exclusively
negotiate for a limited period of time to acquire: (i) a majority equity
interest in Bionic Sight; (ii) the Bionic Sight assets to which the
collaboration agreement relates; or (iii) an exclusive license with respect to
the product to which the collaboration agreement relates.

In March 2021, Bionic Sight, which has responsibility for conducting the
clinical trial, reported promising results in its first two cohorts of patients
in the Phase 1/2 retinitis pigmentosa optogenetics study. Bionic Sight reported
that these patients, all of whom have complete or near-complete blindness, can
now see light and motion, and, in two cases, can detect the direction of motion.
Bionic Sight also announced that the product candidate was well-tolerated and
that it is continuing to enroll patients at higher doses.

Otonomie


During October 2019, we entered into a strategic collaboration agreement with
Otonomy to
co-develop
and
co-commercialize
an
AAV-based
gene therapy product candidate designed to restore hearing in patients with
sensorineural hearing loss caused by a mutation in the gap junction protein beta
2 gene - the most common cause of congenital hearing loss. Under the
collaboration agreement, the parties began equally sharing the program costs and
any proceeds from potential licensing transactions in January 2020 and can
include additional genetic hearing loss targets in the future. Effective
January 1, 2022, we amended the Otonomy collaboration agreement to increase
Otonomy's responsibility for the overall development and commercialization of
the program, which resulted in (i) a reduction in our share of future product
development costs and (ii) our potential receipt of future payments, and
royalties on any product sales in lieu of equal sharing of any potential profits
or proceeds related to the program.

Additional information regarding the Bionic Sight and Otonomy collaborative
agreements can be found in Note 8 to our financial statements in this Annual
Report on Form
10-K.

Preclinical Pipeline

We also have three wholly-owned product candidates in preclinical testing,
including
AGTC-701
for the treatment of dAMD,
AGTC-601
for the treatment of FTD and
AGTC-801
for the treatment of ALS.

Beoordeling financiële operaties

Omzet


We generate revenue primarily through: (i) collaboration agreements;
(ii) sponsored research arrangements with nonprofit organizations for the
development and commercialization of product candidates; (iii) federal research
and development grant programs; and (iv) licensing arrangements. In the future,
we may generate revenue from product sales (if any products are approved),
license fees, milestone payments, development services, research and development
grants, or from collaboration and royalty payments for the sales of products
developed under licenses of our intellectual property.

We verwachten dat alle inkomsten die we genereren van kwartaal tot kwartaal zullen fluctueren als gevolg van de timing en het bedrag van licentievergoedingen, onderzoeks- en ontwikkelingsprogramma’s, productie-inspanningen en vergoedingen,

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collaboration milestone payments, and the sale of our products, to the extent
that any are approved and successfully commercialized. We do not expect to
generate revenue from product sales for the foreseeable future, if at all. If we
or our collaborators fail to complete the development of our product candidates
in a timely manner or obtain regulatory approval for them, our ability to
generate future revenue and our results of operations, financial position and
cash flows would be materially adversely affected.

Kosten voor onderzoek en ontwikkeling

Onderzoeks- en ontwikkelingskosten bestaan ​​voornamelijk uit kosten gemaakt voor de ontwikkeling van onze productkandidaten en omvatten:

     •    employee-related expenses, including salaries, benefits, travel and
          share-based compensation expense;



     •    expenses incurred under agreements with academic research centers,

contractonderzoeksorganisaties en onderzoekssites die onze

          clinical trials;



  •   license and sublicense fees and collaboration expenses;



     •    costs of acquiring, developing and manufacturing clinical trial
          materials; and


• faciliteiten, afschrijvingen en andere kosten, waaronder directe en

toegerekende kosten voor huur en onderhoud van faciliteiten, verzekeringen en

andere benodigdheden.



Research and development costs are expensed as incurred. Costs for certain
development activities are recognized based on an evaluation of the progress
toward completion of specific tasks, using information and data provided to us
by our vendors and our clinical sites.

We cannot determine with certainty the duration and completion costs of the
current or future clinical trials of our product candidates or if, when, or to
what extent we will generate revenue from the commercialization and sale of any
of our product candidates that obtain regulatory approval. We may never succeed
in achieving regulatory approval for any of our product candidates. The
duration, costs and timing of clinical trials and development of our product
candidates will depend on a variety of factors, including:

     •    the scope, rate of progress and expense of our ongoing clinical trials,
          as well as any additional clinical trials that we are required to, or

besluiten tot, initiëren en andere onderzoeks- en ontwikkelingsactiviteiten;




     •    the timing and level of activity as determined by us or jointly with our
          partners;



  •   the level of funding, if any, received from our partners;



  •   whether or not we elect to cost share with our collaborators;



  •   future clinical trial results;



  •   uncertainties in clinical trial enrollment rates or
      drop-out
      or discontinuation rates of patients;


• hogere kosten en vertraging in verband met fabricage- of testproblemen,

          including ongoing quality assurance, qualifying new vendors and
          developing
          in-house
          capabilities through, among other things, our lease of a new cGMP
          build-to-suit
          manufacturing and quality control facility;



  •   the countries in which trials are conducted;


• mogelijke aanvullende veiligheidsmonitoring of andere onderzoeken op verzoek van

          regulatory agencies or elected as best practice by us;



  •   significant and changing government regulation;



  •   the timing and receipt of any regulatory approvals; and



  •   broader market forces, such as inflation and wage/salary growth.



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Changes in any of these variables over time with respect to the development of a
product candidate could mean a significant change in the costs and timing
associated with the development of that product candidate. For example, if the
FDA or another regulatory authority were to require us to conduct clinical
trials beyond those that we currently anticipate will be required for the
completion of clinical development of a product candidate or if we experience
significant delays in enrollment in or execution of any of our clinical trials,
which could be adversely impacted
by the COVID-19 pandemic, we
could be required to expend significant additional financial resources and time
on the completion of clinical trial activities and development of our product
candidates.

From our inception and through June 30, 2022, we have incurred approximately
$332.1 million in research and development expenses. We expect our research and
development expenses to increase as we continue the development of our product
candidates, explore potential applications of our gene therapy platform in other
indications and execute our plan to open and operate a leased cGMP manufacturing
and quality control facility.

Algemene en administratieve en andere kosten


General and administrative and other expenses primarily consist of salaries and
related costs for personnel, including share-based compensation and travel
expenses for our employees in executive, operational, legal, business
development, finance and human resource functions. Other general and
administrative expenses include costs to support employee training and
development, board of directors' costs, depreciation, insurance,
facility-related costs not otherwise included in research and development
expenses, professional fees for legal services, patent-related expenses, and
accounting, investor relations, corporate communications and information
technology services. We anticipate that our general and administrative and other
expenses will continue to increase in the future as we hire additional employees
to support our research and development efforts, collaboration arrangements and
the potential commercialization of our product candidates, if approved.
Inflation and wage/salary growth could also contribute to higher future costs.
Additionally, if and when we believe that regulatory approval of our first
product candidate appears likely, we anticipate an increase in payroll and
related expenses as a result of our preparation for commercial operations,
especially as it relates to the sales and marketing of any such product
candidate. Our general and administrative expenses are also expected to increase
as we execute our plan to open and operate a leased cGMP manufacturing and
quality control facility.

Beleggingsinkomsten, netto


Investment income, net consists of interest earned on cash and cash
equivalents and held-to-maturity investments in
debt securities. During the year ended June 30, 2022, investment income, net
declined by $17,000 when compared to the prior year, primarily due to a smaller
investment portfolio in the current year that was partially offset by higher
interest rates in the marketplace.

rentekosten


Interest expense during the year ended June 30, 2022 increased by $1.2 million
when compared to the prior year. This increase was primarily due to a higher
average outstanding balance under our collateralized term loan agreement during
the year ended June 30, 2022. Additional information regarding our long-term
loan agreement can be found in Note 7 to our financial statements in this Annual
Report on Form
10-K.

On September 21, 2022, the Federal Reserve Board announced an increase of 0.75%
in the federal funds rate and indicated that further rate increases will be
announced in the short-term to combat rising inflation in the United States.
When the prime rate reported in

De Wall Street Journal

 increases, as was the case with the most recent federal funds rate increase and
is expected to continue in response to projected hikes in the federal funds rate
by the Federal Reserve Board, the cost of borrowing and related interest expense
on our variable-rate debt also increases.

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Profiteer van inkomstenbelastingen


The income tax benefit for the year ended June 30, 2021 was $2.1 million and was
primarily due to the reversal of uncertain tax position liabilities, including
the related interest and penalties. There was no provision for income taxes
during the year ended June 30, 2022 because, among other things, we had no
uncertain tax positions during that reporting period. Additional information
regarding our income taxes can be found in Note 10 to our financial statements
in this Annual Report on Form
10-K.

Kritische grondslagen en schattingen voor financiële verslaggeving


Management's Discussion and Analysis of Financial Condition and Results of
Operations included in this Annual Report on
Form 10-K is
based on our financial statements, which have been prepared assuming that the
Company will continue as a going concern and in accordance with U.S. generally
accepted accounting principles. The preparation of those financial statements
requires us to make estimates and judgments that affect the reported amounts of
assets, liabilities, revenue and expenses and the disclosure of contingent
assets and liabilities. On an ongoing basis, we evaluate our estimates,
judgments and methodologies, including those related to accrued expenses and
share-based compensation. We base our estimates on historical experience,
current conditions, known trends and events, and various other factors that are
believed to be reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying values of assets and liabilities
that are not readily apparent from other sources. Actual results may differ from
our estimates under different assumptions or conditions. Moreover, we may need
to change the assumptions underlying our estimates due to risks and
uncertainties related to
the COVID-19 pandemic
or otherwise and those changes could have a material adverse effect on our
statements of operations, financial condition and cash flows. While our
significant accounting policies are described in Note 2 to our financial
statements in this Annual Report on Form
10-K,
we believe that the following accounting policies are most critical to the
preparation of our financial statements.

Opbrengstverantwoording


We recognize revenue when our customer obtains control of promised goods or
services, in an amount that reflects the consideration that we expect to receive
in exchange for those goods or services. To determine the appropriate amount of
revenue to be recognized for arrangements determined to be within the scope of
Accounting Standards Codification Topic 606,
Revenue from Contracts with Customers
, we perform the following five steps: (i) identification of the contract;
(ii) determination of whether the promised goods or services are performance
obligations; (iii) measurement of the transaction price, including any
constraints on variable consideration; (iv) allocation of the transaction price
to the performance obligations; and (v) recognition of revenue when (or as) we
satisfy each performance obligation. We only apply the five-step model to
contracts if it is probable that we will collect consideration that we are
entitled to in exchange for the goods or services we transfer to the customer.

Performance obligations are promises to transfer distinct goods or services to a
customer. Promised goods or services are considered distinct when (i) the
customer can benefit from the good or service on its own or together with other
readily available resources and (ii) the promised good or service is separately
identifiable from other promises in the contract. When assessing whether
promised goods or services are distinct, we consider factors such as the stage
of development of the underlying intellectual property, the capabilities of a
customer to develop the intellectual property on its own or whether the required
expertise is readily available.

We estimate the transaction price based on the amount expected to be received
for transferring the promised goods or services in the contract. The
consideration may include both fixed consideration and variable
consideration. At the inception of an arrangement that includes variable
consideration and at the end of each reporting period, we evaluate the amount of
potential customer payments and the likelihood that such payments will be
received. We utilize either the most likely amount method or the expected amount
method to estimate the amount to be received based on which method better
predicts the amount expected to be received. If it is

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probable that a significant revenue reversal would not occur, the variable
consideration is included in the transaction price. We will assess our revenue
generating arrangements to determine whether a significant financing component
exists and conclude that a significant financing component does not exist in an
arrangement if the: (a) promised consideration approximates the cash selling
price of the promised goods and services or any significant difference is due to
factors other than financing; and (b) timing of payment approximates the
transfer of goods and services and performance is over a relatively short period
of time within the context of the entire term of the contract.

Our contracts often include development and regulatory milestone payments. At
contract inception, we evaluate whether any such milestones are considered
probable of being reached and estimate the amount to be included in the
transaction price using the most likely amount method. If it is probable that a
significant revenue reversal would not occur, the associated milestone value is
included in the transaction price. Milestone payments that are not within our
control or the customer's control, such as regulatory approvals, are not
included in the transaction price. At the end of each subsequent reporting
period, we reevaluate the probability of achievement of such development
milestones and any related constraint and, if necessary, adjust our estimate of
the overall transaction price. Any such adjustments are recorded on a
cumulative catch-up basis,
which would affect collaboration revenue and earnings in the period of
adjustment.

For arrangements that may include sales-based royalties, including milestone
payments based on the level of sales, and the license is deemed to be the
predominant item to which the royalties relate, we recognize revenue at the
later of (i) when the related sale occurs or (ii) when the performance
obligation to which some or all of the royalty has been allocated has been
satisfied (or partially satisfied). To date, we have not recognized any royalty
revenue resulting from any of our collaboration arrangements.

We allocate the transaction price based on the estimated stand-alone selling
price of the underlying performance obligation or, in the case of certain
variable consideration, to one or more performance obligations. We use
assumptions that require judgment to determine the stand-alone selling price for
each performance obligation identified in a contract. We utilize key assumptions
to determine the stand-alone selling price, which may include other comparable
transactions, pricing considered in negotiating the transaction and the
estimated costs to complete the related performance obligation. Certain variable
consideration is allocated specifically to one or more performance obligation in
a contract when the terms of the variable consideration relate to the
satisfaction of a performance obligation and the resulting amounts allocated to
each performance obligation are consistent with the amounts we would expect to
receive for each performance obligation.

For performance obligations consisting of licenses and other promises, we use
judgment to assess the nature of the combined performance obligation to
determine whether the combined performance obligation is satisfied over time or
at a point in time and, if over time, the appropriate method of measuring
progress for the purpose of recognizing revenue from upfront fees. We evaluate
the measure of progress each reporting period and, if necessary, adjust the
measure of performance and related revenue recognition. If the license to our
intellectual property is determined to be distinct from the other performance
obligations identified in the arrangement, we will recognize revenue
from upfront fees allocated to the license when the license is transferred to
the customer and the customer is able to use and benefit from the license.

We receive payments from our customers based on billing terms established in
each contract. Such billings generally
have 30-day payment
terms. Upfront payments and fees are recorded as deferred revenue upon receipt
or when due until we perform our obligations under those arrangements. Amounts
are recorded as accounts receivable when the right to consideration is
unconditional.

Kosten voor onderzoek en ontwikkeling


Research and development expenses are for activities designed to identify,
develop and test product candidates and generally include compensation and
related benefits
and non-cash share-based
compensation for research-

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gerelateerde medewerkers; laboratoriumkosten; onderhoud en benodigdheden voor dieren en laboratoria; huur; Gereedschap; klinische en preklinische kosten; en betalingen voor gesponsord onderzoek, wetenschappelijke en regelgevende advieskosten en testen.


As part of the process of preparing our financial statements, estimates of
accrued expenses are necessary. The estimation process involves reviewing
quotations and contracts, identifying services that have been performed on our
behalf, and determining the level of services performed and associated costs
incurred for services for which we have not yet been invoiced or otherwise
notified of the actual cost. The majority of our service providers invoice
monthly in arrears for services performed or when contractual milestones are
met. We estimate our accrued expenses at the end of each reporting period based
on the facts and circumstances known at that time. As a result, estimates
recorded in our financial statements and disclosed in the accompanying notes may
change in the future and such changes in estimates, if any, will be recorded in
our operating results in the period they are identified by us. The significant
estimates in our accrued research and development expenses primarily relate to
expenses incurred with respect to academic research centers, contract research
organizations and other vendors in connection with research and development
activities for which we have not yet been invoiced.

There are instances where our service providers require advance payments at the
inception of a contract and other circumstances where our payments to a vendor
will exceed the level of services provided, in both cases resulting in a
prepayment of research and development expenses. Such prepayments are charged to
research and development expense as and when the service is provided or when a
specific milestone outlined in the contract is reached.

op aandelen gebaseerde vergoeding


We account for share-based awards issued to employees in accordance with
Accounting Standards Codification Topic 718,
Compensation-Stock Compensation,
and generally recognize share-based compensation expense on a straight-line
basis over the period that an employee is required to provide service in
exchange for the award. In certain instances, we use a graded vesting schedule
to recognize compensation expense. We also award stock options and restricted
stock units to nonemployees in exchange for consulting services. The
determination of share-based compensation costs for nonemployees is generally
consistent with that of employee awards, with expense recognized as services are
provided to us over the related service period.

For purposes of calculating share-based compensation expense, we estimate the
fair value of stock options using a Black-Scholes option-pricing model. The
determination of the fair value of a share-based compensation award utilizing
the Black-Scholes model is affected by our stock price and a number of
assumptions, including the expected volatility of our stock, the expected life
of the stock option, the risk-free interest rate and expected dividends.
Additionally, we use a Monte Carlo simulation model to determine the fair value
of restricted stock units with market-based vesting conditions for purposes of
calculating share-based compensation expense. The Monte Carlo simulation model
incorporates the probability of satisfying a market condition and uses
transaction details such as our stock price, contractual terms, maturity and
risk-free interest rates, as well as volatility. The fair value of restricted
stock units with no performance or market vesting conditions is based on the
market value of our common stock on the date of grant.

If factors change and we employ different assumptions, share-based compensation
expense may differ significantly from what we have recorded in the past. If
there is a difference between the assumptions used in determining share-based
compensation expense and the actual factors that become known over time,
specifically with respect to anticipated forfeitures, we may change the input
factors used in determining share-based compensation costs for future awards.
These changes, if any, may materially impact our results of operations in the
period that such changes are made.

Recente boekhoudkundige uitspraken

Zie toelichting 2 bij onze financiële overzichten in dit jaarverslag op formulier 10-K voor een beschrijving van recente boekhoudkundige uitspraken die van toepassing zijn op ons bedrijf.

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Resultaten van operaties

Vergelijking van de afgelopen jaren 30 juni 2022 en 2021

Omzet

Inkomsten van $ 0,3 miljoen tijdens het afgesloten jaar 30 juni 2022 was van een ontwikkelings- en productiecontract dat we namens een bedrijf met winstoogmerk voltooiden.


Effective April 13, 2021, we entered into a license agreement with a third party
whereby we provided nonexclusive rights to our proprietary cone-specific
promoter technology for use in the development of two
non-competing
products. In connection with this agreement, we recognized $0.5 million of
license fee revenue during the year ended June 30, 2021. Additional information
regarding the license agreement can be found in Note 8 to our financial
statements in this Annual Report on Form
10-K.

Kosten voor onderzoek en ontwikkeling

De onderstaande tabel geeft een overzicht van onze onderzoeks- en ontwikkelingskosten per kandidaat-product of programma voor de aangegeven jaren.


                                           Year Ended June 30,             Increase           % Increase

In thousands                               2022             2021          (Decrease)          (Decrease)
External research and development
expenses:
XLRP                                    $    13,489       $ 15,250       $     (1,761 )               (12 )%
ACHM                                          3,345          4,720             (1,375 )               (29 )%
Research and discovery programs and
X-linked
retinoschisis                                 4,930          3,113              1,817                  58 %

Total external research and
development expenses                         21,764         23,083             (1,319 )                (6 )%

Internal research and development
expenses:
Employee-related costs                       16,717         12,663              4,054                  32 %
Share-based compensation                      1,685          1,110                575                  52 %
Other                                         9,349          7,544              1,805                  24 %

Total internal research and
development expenses                         27,751         21,317              6,434                  30 %

Total research and development
expenses                                $    49,515       $ 44,400       $      5,115                  12 %



External research and development expenses consist of collaboration, licensing,
manufacturing, testing and other miscellaneous costs that are directly
attributable to our most advanced product candidates and discovery programs. We
do not allocate employee-related costs, including share-based compensation,
costs associated with broad technology platform improvements or other indirect
costs, to specific programs, as they are deployed across multiple projects under
development and, as such, are separately classified as internal research and
development expenses in the table above.

Research and development expenses for the years ended June 30, 2022 and 2021
were $49.5 million and $44.4 million, respectively, an increase of $5.1 million,
or 12%. The year-over-year increase was due to various factors, including:
(i) higher employee-related costs that were primarily attributable increased
headcount; (ii) increased external spending for our research and discovery
programs, which was primarily for planned material production costs in
connection with our preclinical programs; (iii) higher share-based compensation
costs that were primarily due to restricted stock units granted to certain
employees from May 2021 to July 2021 (the "2021 RSUs"); and (iv) an increase in
internal research and development expenses for certain assay development that we
are now conducting
in-house,
as well as higher costs for rent, travel and consultants. These increases in
research and development expenses were partially offset by: (i) a year-over-year
reduction in manufacturing activities for Vista clinical trial materials; (ii) a
decrease in ACHM expenses due to reduced site

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activity as our two clinical studies have progressed to a point where they are
no longer activating new sites or enrolling new patients; and (iii) lower costs
in connection with the wind-down of
our X-linked retinoschisis
program. Additionally, research and development expenses for the year ended
June 30, 2022 were favorably impacted by changes in estimates that reduced
certain vendor accruals during such reporting period.

Algemene en administratieve en andere kosten


The table below summarizes our general and administrative and other expenses for
the years indicated.


                                           Year Ended June 30,             Increase           % Increase

In thousands                               2022             2021          (Decrease)          (Decrease)
Employee-related costs                  $     6,301       $  5,312       $        989                  19 %
Share-based compensation                      1,740          1,568                172                  11 %
Legal and professional fees                     876          1,636               (760 )               (46 )%
Other                                         8,068          6,035              2,033                  34 %

Total general and administrative
and other expenses                      $    16,985       $ 14,551       $      2,434                  17 %



General and administrative and other expenses for the years ended June 30, 2022
and 2021 were $17.0 million and $14.6 million, respectively, an increase of
$2.4 million, or 17%. The increase was primarily due to: (i) compensation for
new employees; (ii) incremental share-based compensation costs from the 2021
RSUs;
(iii) start-up
costs for our
build-to-suit manufacturing
and quality control facility; and (iv) higher business development, investor
relations and insurance costs. Lower legal fees during the year ended June 30,
2022 were due to reduced use of external legal counsel.

Liquiditeit en kapitaalbronnen


We have incurred cumulative losses and negative cash flows from operations since
our inception and, as of June 30, 2022, we had an accumulated deficit of
$308.2 million. We believe that there is presently insufficient funding
available to allow us to generate data from our ongoing and planned clinical
programs and fund currently planned research and discovery programs for a period
exceeding 12 months from the date of this filing with the SEC. While we expect
to generate some revenue from collaborations, sponsored research agreements,
grants and licensing of our intellectual property, we believe that we will incur
losses and generate negative operating cash flows for the foreseeable future. As
such, these circumstances collectively raise substantial doubt about our ability
to continue as a going concern.
During this 12-month period, our
future liquidity needs will be primarily based on the: (i) success and
progression of our efforts to complete a strategic transaction, including a
merger; (ii) the progress we are able to make on the development of our product
candidates; (iii) repayment obligations under our long-term debt agreement; and
(iii) costs to operate
our leased build-to-suit manufacturing and
quality control facility. It will be several years, if ever, before we have a
product candidate ready for commercialization. We expect that our research and
development expenses and general and administrative and other expenses will
continue to increase and, as a result, we anticipate that we will require
additional capital to fund our operations, which we may raise through a
combination of strategic transactions, including a merger, and equity and debt
offerings.

Most recently, we received: (i) net proceeds of $9.0 million subsequent to
June 30, 2022 from an underwritten public offering of our common stock, together
with accompanying warrants, which is described in Note 15 to our financial
statements in this Annual Report on Form
10-K;
(ii) net proceeds of $9.2 million and $69.3 million during the years ended
June 30, 2022 and 2021, respectively, from underwritten public offerings and
selling our common stock through an
"at-the-market
offering" program, which are described in Note 13 to our financial statements in
this Annual Report on Form
10-K;
and (iii) $9.9 million of loan proceeds, net of debt discounts, in May 2021.
Moreover, through a tenant improvement allowance and tiered rental rates, we
have structured the

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third-party leasing costs for our
build-to-suit
manufacturing and quality control facility in Alachua, Florida in a way that
will not significantly impact our cash runway until the fiscal year ending
June 30, 2024. Notwithstanding the foregoing, we used our available cash and
cash equivalents to fund approximately $2.9 million of tenant fit out work at
such facility in August 2022, which represented our required contribution
pursuant to a recent lease amendment. Additional information regarding our new
manufacturing and quality control facility and long-term loan agreement can be
found in Notes 3 and 7, respectively, to our financial statements in this Annual
Report on Form
10-K.

We are closely monitoring ongoing developments in connection with the
COVID-19
pandemic, which may negatively impact our projected cash position and access to
capital. We will continue to assess our cash position and any progress we make
towards the completion of one or more strategic transactions and, if
circumstances warrant, make appropriate adjustments to our operating plan.

Cash in excess of immediate requirements is invested in accordance with our
investment policy, which primarily seeks to maintain adequate liquidity and
preserve capital by generally limiting investments to certificates of deposit
and investment-grade debt securities that mature within twelve months. As of
June 30, 2022, our cash and cash equivalents were held in bank accounts and
money market funds.

Geld rolt


The table below sets forth the primary sources and uses of cash for the years
indicated.


                                        Year Ended June 30,             Increase           % Increase

In thousands                           2022             2021           (Decrease)          (Decrease)
Cash provided by (used in):
Operating activities                 $ (65,748 )      $ (51,173 )      $   (14,575 )               (28 )%
Investing activities                       (14 )         38,147            (38,161 )             >(100 )%
Financing activities                     7,076           79,615            (72,539 )               (91 )%

Net increase (decrease) in cash
and cash equivalents                 $ (58,686 )      $  66,589        $  (125,275 )             >(100 )%



Operating activities.
For both the years ended June 30, 2022 and 2021, cash used in operating
activities was primarily the result of research and development expenses and
general and administrative and other expenses incurred in conducting normal
business operations. Specifically, the cash used in operating activities of
$65.7 million during the year ended June 30, 2022 was due to a net loss of
$68.9 million and unfavorable changes in our operating assets and liabilities of
$3.2 million, partially offset
by non-cash items
in our statement of operations of $$6.4 million. The cash used in operating
activities of $51.2 million during the year ended June 30, 2021 was due to a net
loss of $57.8 million, partially offset by
non-cash
items in our statement of operations of $2.8 million and favorable changes in
our operating assets and liabilities of $3.9 million.

Investing activities.
Cash used in investing activities during the year ended June 30, 2022, which was
nominal, consisted of purchases of property and equipment of $1.7 million and
intellectual property costs of $0.3 million, partially offset by cash proceeds
of $2.0 million from maturities of investments. Cash provided by investing
activities of $38.1 million during the year ended June 30, 2021 consisted of
cash proceeds of $61.0 million from maturities of investments, net of investment
purchases of $21.0 million, partially offset by purchases of property and
equipment of $1.5 million and intellectual property costs of $0.4 million.

Financing activities.
Cash provided by financing activities of $7.1 million during the year ended
June 30, 2022 consisted of proceeds of $9.2 million from issuances of our common
stock, net of issuance costs, and proceeds from exercises of common stock
options of $0.1 million, partially offset by: (i) principal payments on
long-term debt of $2.2 million; (ii) payments for taxes related to equity
awards; and (iii) principal payments on a finance

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huren.

Cash provided by financing activities of $79.6 million during the year ended
June 30, 2021 included: (i) proceeds of $69.3 million from the issuance of
common stock and accompanying warrants, net of issuance costs; (ii) net cash
received of $9.9 million from a second term loan advance under our
collateralized debt arrangement; and (iii) proceeds from exercises of common
stock options of $0.8 million. These items were partially offset by (i) payments
for deferred financing fees and taxes related to equity awards and
(ii) principal payments on a finance lease.

Bedrijfskapitaalvereisten


We have not generated any revenue from product sales and we do not know when, or
if, we will generate such revenue. We do not expect to have significant revenue
from product sales unless and until we obtain regulatory approval of and
commercialize one of our current or future product candidates. We anticipate
that we will continue to generate losses as we continue the development of, and
seek regulatory approvals for, our product candidates, and begin to
commercialize any approved products. We are subject to all of the risks inherent
in the development of new gene therapy products, and we may encounter unforeseen
expenses, difficulties, complications, delays and other unknown factors that may
adversely affect our business.

We believe that our available cash and cash equivalents, which totaled
$46.4 million on June 30, 2022, along with the net proceeds that we received
from an underwritten public offering in July 2022, will be sufficient to allow
us to generate data from our ongoing and planned clinical programs and fund
currently planned research and discovery programs through calendar year 2022.
However, we will require substantial additional funding to: (i) finish our Vista
trial; (ii) move our ACHMB3 product candidate forward; (iii) complete the
process necessary to seek regulatory approval for our lead product candidates;
(iv) build the sales, marketing and distribution infrastructure that we believe
will be necessary to commercialize our lead product candidates, if approved; and
(v) execute our plan to open and operate a leased cGMP manufacturing and quality
control facility.

To provide the maximum degree of financial flexibility, we may consider various
potential opportunities to fund future operations and/or modulate liquidity
needs, including: (i) seeking various strategic transactions, including a
merger, that provide funding for our programs; (ii) entering into one or more
collaborations to offset the costs of our leased manufacturing and quality
control facility; (iii) reducing our expenditures on research and development
activities and/or restructuring our operations; and (iv) raising new capital
through equity or debt financings or other sources; however, upon the filing of
this Annual Report on Form
10-K,
we will be limited in our ability to use our shelf registration statement on
file with the SEC due to a decrease in our overall market capitalization since
the filing of our 2021 Annual Report on Form
10-K.
We may be unable to successfully execute any of the plans described above, raise
additional funds or enter into such other arrangements when needed on favorable
terms, or at all. Additional information regarding our liquidity and related
matters can be found in Note 1 to our financial statements in this Annual Report
on Form 10-K
under the heading "Liquidity and Financial Condition."

Uit balans

blad arrangementen


During the years presented in this Annual Report on Form
10-K
and as of June 30, 2022, we did not have any
off-balance
sheet arrangements, as defined in the rules and regulations of the Securities
and Exchange Commission.

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