Unless the context otherwise requires, all references in this section to the
"Company," "we," "us," or "our" refer to RenovoRx, Inc. You should read the
following discussion and analysis of our financial condition and results of
operations in conjunction with our unaudited interim condensed financial
statements and related notes included elsewhere in this Quarterly Report on Form
10-Q, our management's discussion and analysis of financial condition and
results of operations for the year ended December 31, 2021, included in our
Annual Report on Form 10-K that was filed with the SEC on March 30, 2022 (the
"Annual Report"), and our final prospectus, dated August 25, 2021, filed with
the SEC pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended
(the "Securities Act").
This discussion contains forward-looking statements within the meaning of
Section 27A of the Securities Act and Section 21E of the Securities Exchange Act
of 1934, as amended, that reflect our plans, estimates, and beliefs that involve
risks and uncertainties, including those described in the section titled
"Forward Looking Statements." Our actual results and the timing of selected
events could differ materially from those discussed below. Factors that could
cause or contribute to such differences include, but are not limited to, those
identified below and those set forth under the section titled "Risk Factors"
included elsewhere in this Quarterly Report and in the Annual Report.
Overview
We are a clinical-stage biopharmaceutical company focused on developing
therapies for the local treatment of solid tumors.
We are currently conducting a Phase III registrational trial for our lead
product candidate RenovoGem™. Our therapy platform, RenovoRx Trans-Arterial
Micro-Perfusion, or RenovoTAMP™®, utilizes approved chemotherapeutics with
validated mechanisms of action and well-established safety and side effect
profiles, with the goal of increasing their efficacy, improving their safety,
and widening their therapeutic window by combining such chemotherapeutics with
our proprietary drug delivery system. RenovoTAMP combines our patented Food and
Drug Administration, ("FDA") cleared delivery system, RenovoCath®, with small
molecule chemotherapeutic agents that can be forced across the vessel wall using
pressure, targeting these anti-cancer drugs locally to the solid tumors. While
we anticipate investigating other chemotherapeutic agents for intra-arterial
delivery via RenovoTAMP, our clinical work to date has focused on gemcitabine,
which is a generic small molecule drug. Our first product candidate, RenovoGem,
is a drug/device combination consisting of intra-arterial gemcitabine and
RenovoCath. FDA has determined that RenovoGem will be regulated as, and if
approved we expect will be reimbursed as, a new oncology drug product. We have
secured FDA Orphan Drug Designation for RenovoGem in two indications: pancreatic
cancer and cholangiocarcinoma (bile duct cancer, or CCA). We have completed our
RR1 Phase I/II and RR2 observational registry studies, with 20 and 25 patients
respectively, in locally advanced pancreatic cancer, or LAPC. These studies
demonstrated a median overall survival of 27.9 months from diagnosis in patients
pre-treated with radiation followed by treatment with RenovoGem. Based on
previous large randomized clinical trials, the expected survival of LAPC
patients is 12 - 15 months in patients receiving only intravenous (IV) systemic
chemotherapy or IV chemotherapy plus radiation (which are both considered
standard of care). Unlike the randomized trials that established these
standard-of-care results, our RR1 and RR2 clinical trials did not prospectively
control the standard of care therapy received prior to administration of
RenovoGem. Based on an FDA safety review of our Phase I/II study, FDA allowed us
to proceed to evaluate RenovoGem within our Phase III registrational clinical
trial.
As previously disclosed, in December 2021 we amended the protocol for this
clinical trial to only allow for stereotactic body radiation therapy (SBRT)
during the induction phase of the study (prior to randomization). We had
previously permitted both SBRT and intensity-modulated radiation therapy (IMRT).
Patients receiving IMRT must complete 25 radiation treatments in combination
with oral chemotherapy during the induction phase of the study, which takes
between 35 and 56 days to complete. In comparison, patients receiving SBRT
during the induction phase are only required to complete 5 treatments, over 5
consecutive days, and do not receive oral chemotherapy. The decision to modify
the study population was based on the observation in the Phase III TIGeR-PaC
study that IMRT patients had a higher dropout rate during the induction phase of
the study due to the high frequency of hospital visits and side effects from the
required concurrent chemotherapy. As part of the pre-randomization, induction
phase change made to the protocol, we initiated a review of the statistical
considerations for the study and in June 2022, submitted a modified Statistical
Analysis Plan (the "Modified SAP") to FDA. As part of the Modified SAP, we now
plan to (i) analyze only patients receiving SBRT, consistent with the protocol
change made in December 2021, (ii) include a second interim analysis, (iii)
change the total number of SBRT patients randomized in the study to 114 (a
reduction from the original 200 patients) with a total of 86 deaths from SBRT
patients, including all deaths from SBRT patients enrolled in the study before
the submission of the Modified SAP, and (iv) repower the study from 90% to 80%,
which is commonly used in clinical trials. We believe these changes will shorten
the timeframe needed to complete the study and also significantly decrease our
costs. We have not discussed the protocol amendment or the Modified SAP with the
FDA, and we cannot provide any assurance that the FDA will agree with these
modifications. The first planned interim analysis is triggered when 30%, or 26
of 86, of the total number of deaths have occurred, and the second interim
analysis at 60%, or 52 of 86, of the total number of deaths have occurred. Given
that the timing of the interim analysis is predicated on a specific number of
deaths, it is difficult to predict the exact timing of the interim analysis or
when we will be able to complete the study. As of November 14, 2022, the Phase
III TIGeR-PaC trial has randomized 37 SBRT patients out of 114 total needed
under the Modified SAP. At this rate, we anticipate that all patients will be
enrolled and randomized in 2024, with the final study readout in 2025. We plan
to submit a protocol amendment to FDA in the fourth quarter of 2022 to reflect
the changes in the Modified SAP.
13
We are also planning to evaluate RenovoGem in a second indication in a Phase
II/III trial in extrahepatic (or outside the liver) cholangiocarcinoma (or
eCCA), cancer that occurs in the bile ducts that lead out of the liver and join
with the gallbladder. After significant input from key opinion leaders across
the spectrum of relevant medical specialties and feedback from the FDA, we
submitted the protocol for a Phase II/III eCCA clinical trial to FDA. If FDA
does not object to our study protocol, we anticipate launching the eCCA trial
and enrolling the first patient in the fourth quarter of 2022 or the first
quarter of 2023. In addition, we may evaluate RenovoGem in other indications,
potentially including locally advanced lung cancer, locally advanced uterine
tumors, and glioblastoma (an aggressive type of cancer that can occur in the
brain or spinal cord). To date, we are focused on developing drug/device
candidates with gemcitabine, but in the future, we may develop other product
candidates with other chemotherapeutic agents for intra-arterial delivery via
our RenovoTAMP therapy platform.
Since our inception, we have devoted substantially all of our efforts to
developing our cancer therapy platform and product candidates, raising capital
and organizing and staffing our Company. To date, we have financed our
operations primarily through issuance of convertible preferred stock with net
proceeds of $11.8 million, convertible notes with net proceeds of $5.0 million,
and a loan of $140,000 pursuant to the Paycheck Protection Program under the
Coronavirus Aid, Relief and Economic Security Act (the "CARES Act"), which was
forgiven in February 2021. In August 2021, we completed our IPO with aggregate
gross proceeds of $16.7 million. We paid underwriting discounts and commissions
of $1.3 million, and incurred expenses of $0.8 million in connection with the
offering. As a result, the net offering proceeds to us, after deducting
underwriting discounts and commissions and offering expenses, were $14.6
million.
We have incurred significant operating losses and generated negative cash flows
from operations since our inception. As of September 30, 2022, we had cash and
cash equivalents and short-term marketable securities of $8.1 million. For the
three and nine months ended September 30, 2022, we reported net losses of $2.1
million and $7.7 million, respectively. As of September 30, 2022, we had an
accumulated deficit of $29.0 million. We expect to continue to incur significant
expenses, increasing operating losses and negative cash flows from operations in
2022 and for the foreseeable future. We do not expect to generate revenues from
product sales unless and until we successfully complete development and obtain
regulatory approval for one or more product candidates. We expect that our
expenses will increase substantially in connection with our ongoing research and
development activities, particularly as we:
? Advance clinical development of RenovoGem and our platform technology by
continuing to enroll patients in our ongoing Phase III TIGeR-PaC clinical
trial, expanding the number of clinical trials including our planned clinical
trial in eCCA, and advancing RenovoGem through preclinical and clinical
development in additional indications;
? Hire additional research, development, engineering, and general and
administrative personnel;
? Maintain, expand, enforce, defend, and protect our intellectual property
portfolio; and
? Expand our operational, financial and management systems and increase
personnel, including personnel to support our clinical development,
manufacturing and commercialization efforts and our operations as a public
company.
14
In addition to the variables described above, if and when any of our product
candidates successfully complete development, we will incur substantial
additional costs associated with establishing a sales, marketing, medical
affairs and distribution infrastructure to commercialize products for which we
may obtain marketing approval, regulatory filings, marketing approval, and
post-marketing requirements, in addition to other commercial costs. We cannot
reasonably estimate these costs at this time.
As a result, we will need significant additional funding to support our
continuing operations. Until such time, if ever, as we can generate substantial
product revenue, we expect to finance our cash needs through equity issuances,
debt financings and collaborations, licenses or other similar arrangements. We
currently have no credit facility or committed sources of capital. To the extent
that we raise additional capital through the future sale of equity or debt, the
ownership interests of our stockholders will be diluted, and the terms of these
securities may include liquidation or other preferences that adversely affect
the rights of our existing common stockholders. If we raise additional funds
through the issuance of debt securities, these securities could contain
covenants that would restrict our operations. We may require additional capital
beyond our currently anticipated amounts and additional capital may not be
available on reasonable terms, or at all. If we raise additional funds through
collaboration arrangements or other strategic transactions in the future, we may
have to relinquish valuable rights to our technologies or future revenue streams
or grant licenses on terms that may not be favorable to us. If we are unable to
raise additional funds through equity or debt financing when needed, we may be
required to delay, limit, reduce or terminate development or future
commercialization efforts.
Impact of COVID-19
In December 2019, a novel strain of coronavirus, which causes the disease known
as COVID-19, was reported to have surfaced in Wuhan, China. Since then,
COVID-19, including recent variants, has spread globally. In March 2020, the
World Health Organization declared the COVID-19 outbreak a pandemic. The ongoing
COVID-19 global and national health emergency has caused significant disruption
in the international and U.S. economies and financial markets. The continued
spread of COVID-19, and its variants, has caused illness, quarantines,
cancellation of events and travel, business and school shutdowns, reduction in
business activity and financial transactions, labor shortages, supply chain
interruptions and overall economic and financial market instability.
In response to public health directives and orders and to help minimize the risk
of the virus to employees, we have taken precautionary measures, including
implementing hybrid work policies for certain employees. The ongoing COVID-19
global pandemic also has negatively affected, and we expect will continue to
negatively affect, our clinical studies. For example, we have faced challenges
in conducting our clinical trials, including recruiting subjects and
accommodating patient visits. Additionally, our service providers and their
operations may be disrupted, temporarily closed or experience worker or supply
shortages, which could result in additional disruptions or delays in shipments
of purchased materials or the continued development of our product candidates.
To date, we have not suffered material supply chain disruptions.
We are not able to estimate the duration of the pandemic and the potential
impact on our business. As the COVID-19 global pandemic continues to evolve, it
could result in significant long-term disruption of global financial markets,
including a period of a rising rate of inflation, reducing our ability to raise
additional capital when needed and on acceptable terms, if at all, which could
negatively affect our liquidity. The extent to which the COVID-19 pandemic
impacts our clinical development and regulatory efforts will depend on future
developments that are highly uncertain and cannot be predicted with confidence,
such as the duration of the continued outbreak, new travel restrictions,
quarantines and social distancing requirements in the United States and other
countries, business closures or business disruptions and the effectiveness of
actions taken in the United States and other countries to contain and treat the
virus. We will continue to monitor the COVID-19 situation closely.
15
Components of Our Results of Operations
Revenue
We have not generated any revenue from product sales and do not expect to
generate any revenue from the sale of products for several years, if at all. If
our development efforts for our current or future product candidates are
successful and result in marketing approval or collaboration or license
agreements with third parties, we may generate revenue in the future from a
combination of product sales or payments from collaboration or license
agreements.
Operating Expenses
Research and Development
Research and development expenses consist of costs related to the research and
development of our platform technology. Clinical trial costs are a significant
component of research and development expenses and include costs associated with
third-party contractors and consultants. We outsource a substantial portion of
our clinical trial activities, utilizing the service of third-party clinical
trial sites and contract research organizations to assist us with the execution
of our clinical trials. In addition, we have FDA 510(k) clearance for the
RenovoCath delivery device, which comprises part of the RenovoGem product.
Accordingly, we are able to charge our clinical trial sites for the RenovoCath
delivery device. To date, payments from clinical trial sites in consideration
for RenovoCath delivery devices have been adequate to cover our direct
manufacturing costs. Any payments we receive from clinical trial sites as
consideration for use of RenovoCath delivery devices offset our research and
development expenses. We expect our research and development expenses to
increase for the foreseeable future as we continue the development of our
product candidates and enroll subjects in our ongoing Phase III clinical trial,
initiate new clinical trials and pursue regulatory approval of our product
candidates. It is difficult to predict with any certainty the duration and costs
of completing our current or future clinical trials of our product candidates or
if, when or to what extent we will achieve regulatory approval and generate
revenue from the commercialization and sale of our product candidates. The
duration, costs and timing of clinical trials and other development of our
product candidates will depend on a variety of factors, including uncertainties
in clinical trial enrollment, timing and extent of future clinical trials,
development of new product candidates and significant and changing government
regulation. We may never succeed in achieving regulatory approval for any of our
product candidates.
Our research and development expenses include:
? expenses incurred under agreements with clinical trial sites, contract
research organizations, and consultants that are involved in conducting our
clinical trials;
? costs of acquiring and developing clinical trial materials;
? personnel costs, including salaries, benefits, bonuses, and stock-based
compensation for employees engaged in preclinical and clinical research and
development;
? costs related to compliance with regulatory requirements;
? third-party vendor costs related to manufacturing materials and testing;
? costs related to preclinical studies and pilot testing;
? travel expenses; and
? allocated general and administrative expenses which includes facilities and
other indirect administrative expenses to support research and development
activities.
16
Research and development costs are expensed as incurred. Costs for certain
development activities, such as clinical trials and preclinical studies, are
recognized based on evaluation of progress to completion of specific tasks using
data such as subject enrollment, clinical site activations or information
provided to us by third party vendors.
Due to the ongoing impact of the COVID-19 pandemic and work-from-home policies
and other operational limitations mandated by federal, state, and local
governments as a result of the pandemic, certain of our research and development
activities have been delayed and may be further delayed until we and our vendors
return to pre-pandemic capacity.
General and Administrative
General and administrative expenses consist of salaries, benefits, and
stock-based compensation for personnel in executive, finance and administrative
functions, professional services and associated costs related to accounting,
tax, audit, legal, intellectual property and other matters, consulting costs,
conferences, travel and allocated expenses for rent, insurance and other general
overhead costs. We expect to continue to incur additional expenses as a result
of operating as a public company, including costs to comply with the rules and
regulations of the Securities and Exchange Commission, or SEC, and Nasdaq
listing standards and increased expenses in the areas of insurance, professional
services and investor relations. As a result, we expect our general and
administrative expenses to increase in the foreseeable future. General and
administrative expenses are expensed as incurred.
Other Income (Expenses), Net
Interest Income (Expense) Net
Interest income, net during the three and nine months ended September 30, 2022,
relates to interest earned from cash deposited in our money market account and
our available-for-sale securities.
Interest expense, net during the three and nine months ended September 30, 2021
consisted of charges relating to the amortization of the debt discount and debt
issuance costs as well as interest on amounts outstanding on our 2020 and 2021
Convertible Notes.
Other Income (Expense), Net
Other expense, net during the three and nine months ended September 30, 2021,
represents the mark-to-market adjustment on the derivative liability resulting
from the 2020 and 2021 Convertible Notes. Upon the completion of our IPO in
August 2021, the 2020 and 2021 Convertible Notes were converted into units
consisting of (a) one share of common stock and (b) one five-year warrant to
purchase one share of common stock at an exercise price equal to $10.80 per
share.
Gain on Loan Extinguishment
The gain on loan extinguishment during the nine months ended September 30, 2021
represents the loan extinguishment from the forgiveness and cancellation of our
loan pursuant to the Paycheck Protection Program ("PPP") as well as the loss
from the conversion and settlement of our 2020 and 2021 Convertible Notes.
Income Tax Expense
We account for income taxes using the asset and liability method. Under this
method, deferred income tax assets and liabilities are recorded based on the
estimated future tax effects of differences between the financial statement and
income tax basis of existing assets and liabilities. Deferred income tax assets
and liabilities are recorded net and classified as noncurrent on the balance
sheets. A valuation allowance is provided when it is more likely than not that
some portion or all of a deferred tax asset will not be realized.
17
We are subject to income taxes in the federal and state jurisdictions. Tax
regulations within each jurisdiction are subject to the interpretation of the
related tax laws and regulations and require significant judgment to apply. In
accordance with the authoritative guidance on accounting for uncertainty in
income taxes, we recognize tax liabilities for uncertain tax positions when it
is more likely than not that a tax position will not be sustained upon
examination and settlement with various taxing authorities. Liabilities for
uncertain tax positions are measured based upon the largest amount of benefit
that is more-likely-than-not (greater than 50%) of being realized upon
settlement. Our policy is to recognize interest and/or penalties related to
income tax matters in income tax expense.
On March 27, 2020, the CARES Act was enacted. The CARES Act includes several
significant provisions for corporations, including the usage of net operating
losses, interest deductions and payroll benefits. Corporate taxpayers may
carryback net operating losses, or NOLs, originating during 2018 through 2020
for up to five years.
Results of Operations
The following table summarizes the significant components of our results of
operations for the periods presented (in thousands):
Three Months Ended Nine Months Ended
September 30, September 30,
2022 2021 2022 2021
Statements of Operations Data:
Operating expenses:
Research and development $ 846 $ 767 $ 3,525 $ 1,938
General and administrative 1,315 628 4,255 1,377
Total operating expenses 2,161 1,395 7,780 3,315
Loss from operations (2,161 ) (1,395 ) (7,780 ) (3,315 )
Other income (expense), net
Interest income (expense), net 22 (208 ) 43 (835 )
Other income (expense), net 3 170 4 119
(Loss) gain on loan extinguishment - (78 ) - 62
Total other income (expense), net 25 (116 ) 47 (654 )
Net loss $ (2,136 ) $ (1,511 ) $ (7,733 ) $ (3,969 )
Comparison of the Three Months Ended September 30, 2022 and 2021
The following table summarizes the significant components of our results of
operations for the periods presented (in thousands, except percentages):
Three Months Ended Increase /
September 30, (Decrease)
2022 2021 $ %
(unaudited)
Operating expenses:
Research and development $ 846 $ 767 $ 79 10 %
General and administrative 1,315 628 687 109 %
Total operating expenses 2,216 1,395 766 55 %
Loss from operations (2,216 ) (1,395 ) (766 ) (55 )%
Other income (expense), net
Interest income (expense), net 22 (208 ) 230 111 %
Other income (expense), net 3 170 (167 ) (98 )%
Loss on loan extinguishment - (78 ) 78 100 %
Total other income (expense), net 25 (116 ) 141 122 %
Net loss $ (2,136 ) $ (1,511 ) $ (625 ) (41 )%
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Research and Development
Research and development expenses were $0.8 million for the three months ended
September 30, 2022 and 2021, respectively. Clinical consulting to support the
ongoing Phase III trial increased $0.2 million which was offset by a decrease in
our Phase III trial costs of $0.4 million primarily due to scaling down the
European Phase III trial. Preclinical research and development and regulatory
expenses increased by $0.2 million for the three months ended September 30,
2022, compared to the prior year quarter, and represent costs associated with
establishing a secondary manufacturer for RenovoCath delivery devices of $0.1
million, and regulatory and quality assurance consulting expense of $0.1
million. Payments received from clinical trial sites for the use of the
RenovoCath devices have been adequate to cover our direct costs of manufacturing
the delivery devices and offset research and development expenses. Allocated
general and administrative support costs for personnel, facility and office
supply costs increased by $0.1 million compared to the prior year quarter. We
expect research and development expenses to increase during the year.
General and Administrative
General and administrative expenses were $1.3 million for the three months ended
September 30, 2022, an increase of $0.7 million, compared to $0.6 million for
the prior year quarter. This increase was due to higher employee and related
benefits costs of $0.2 million, an increase in legal fees of $0.1 million,
reflecting the increased costs of public company compliance requirements, and a
$0.2 million increase in professional and consulting services expenses relating
to post-IPO support, in each case, as compared to the prior year quarter. The
increase also includes directors and officers liability insurance expense of
$0.2 million, partially offset by an increase of $0.1 million in the allocation
of general and administrative expenses to research and development. We expect
general and administrative expenses to increase during the fiscal year as we
continue to grow.
Interest Income (Expense), Net
Interest income for the three months ended September 30, 2022, was $22,000,
compared to $0.2 million expense in the prior year quarter. The decrease in
interest expense is due to the conversion of the 2020 and 2021 Convertible Notes
into common shares in connection with the IPO. We do not expect to incur
additional interest expenses this year.
Other Income (Expense), Net
Other income (expense), net for the three months ended September 30, 2022, was
$3,000, compared to $0.2 million income in the prior year quarter. The decrease
in other income primarily represents the mark-to-market adjustment on the
derivative liability resulting from the conversion of the 2020 and 2021
Convertible Notes into common shares in connection with the IPO in August 2021.
Loss on Loan Extinguishment
The loss on loan extinguishment, represents the unamortized debt discount on our
2020 and 2021 Convertible Notes, of $78,000 during the three months ended
September 30, 2021 resulted from the conversion of the 2020 and 2021 Convertible
Notes upon the completion of our IPO in August 2021.
19
Comparison of the Nine Months Ended September 30, 2022 and 2021
The following table summarizes the significant components of our results of
operations for the periods presented (in thousands, except percentages):
Nine Months Ended Increase /
September 30, (Decrease)
2022 2021 $ %
(unaudited)
Operating expenses:
Research and development $ 3,525 $ 1,938 $ 1,587 82 %
General and administrative 4,255 1,377 2,878 209 %
Total operating expenses 7,780 3,315 4,465 135 %
Loss from operations (7,780 ) (3,315 ) (4,465 ) (135 )%
Other income (expense), net
Interest income (expense), net 43 (835 ) 878 105 %
Other income (expense), net 4 119 (115 ) (97 )%
Gain on loan extinguishment - 62 (62 ) (100 )%
Total other expense, net 47 (654 ) 701 107 %
Net loss $ (7,733 ) $ (3,969 ) $ (3,764 ) (95 )%
Research and Development
Research and development expenses were $3.5 million for the nine months ended
September 30, 2022, an increase of $1.6 million, compared to $1.9 million for
the prior year period. This increase was primarily due to clinical consulting to
support the ongoing Phase III trial of $0.7 million and employee and related
benefits of $0.1 million, offset by a decrease in clinical development expenses
of $0.5 million due to a lower patient enrollment during 2022 and the scaling
down of our European Phase III trial. Preclinical research and development and
regulatory expenses increased by $0.8 million for the nine months ended
September 30, 2022, compared to the prior year period, and represent costs
associated with establishing a secondary manufacturer for RenovoCath delivery
devices of $0.4 million, contracted research and supplies expense of $0.3
million and marketing and trade shows of $0.1 million. Payments for use of
RenovoCath delivery devices were $0.1 million for the nine months ended
September 30, 2022, which represent the cash payment made by clinical trial
sites for the devices used in the Phase III clinical trial, decreased by $0.1
million during 2022. To date, payments received from clinical trial sites for
the devices have been adequate to cover our direct costs of manufacturing the
RenovoCath delivery devices and offset research and development expenses.
Allocated general and administrative support costs for personnel, facility and
office supply costs increased by $0.3 million, compared to the prior year
period. We expect research and development expenses to increase during the year.
General and Administrative
General and administrative expenses were $4.3 million for the nine months ended
September 30, 2022, an increase of $2.9 million, compared to $1.4 million for
the prior year period. This increase was due to higher employee and related
benefits costs of $0.7 million, an increase in legal fees of $0.3 million,
reflecting the increased costs of public company compliance requirements, and a
$1.1 million increase in professional and consulting services expenses relating
to post-IPO support as compared to the prior year period. The increase also
includes directors and officers liability insurance expense of $0.9 million and
$0.2 million in Delaware franchise tax expense, partially offset by an increase
of $0.3 million in the allocation of general and administrative expenses to
research and development. We expect general and administrative expenses to
increase during the fiscal year.
Interest Income (Expense), Net
Interest income for the nine months ended September 30, 2022, was $43,000
compared to $0.8 million in expense the prior year period. The decrease in
interest expense is due to the conversion of the 2021 Convertible Notes into
common shares in connection with the IPO. We do not expect to incur additional
interest expenses this year.
20
Other Income (Expense), Net
Other income, net for the nine months ended September 30, 2021 was $0.1 million
and represents the mark-to-market adjustment on the derivative liabilities
resulting from the 2020 and 2021 Convertible Notes.
Gain on Loan Extinguishment
The gain on loan extinguishment for the nine months ended September 30, 2022 was
nil compared to $62,000 in the prior year period and represented the forgiveness
and cancelation of our PPP loan of $140,000 offset by the loss on the automatic
conversion of the 2020 and 2021 Convertible Notes upon completion of our IPO in
August 2021. We do not expect to incur any loan extinguishment costs this year.
Liquidity and Capital Resources
For the three and nine months ended September 30, 2022, we incurred a net loss
of $2.1 million and $7.7 million, respectively. As of September 30, 2022, we had
an accumulated deficit of $29.0 million. We expect to incur additional losses
and increase operating expenses in future periods. Since our inception, our
primary sources of liquidity have been the sale and issuance of convertible
preferred stock, convertible notes and common stock, including in our IPO, and
from the exercise of warrants.
As of September 30, 2022 and December 31, 2021, we had $8.1 million and $15.2
million in cash and cash equivalents and short-term marketable securities,
respectively. During the nine months ended September 30, 2022, we used $7.1
million of cash in operations. Our primary requirements for liquidity have been
to fund our clinical trial activity and general corporate and working capital
needs. In August 2021, we completed our IPO and received aggregate gross
proceeds of $16.7 million. We paid underwriting discounts and commissions of
$1.3 million, and we also incurred expenses of $0.8 million in connection with
the offering. As a result, the net offering proceeds to us, after deducting
underwriting discounts and commissions and offering expenses, were $14.6
million. In February 2021, we received notification and confirmation from
Silicon Valley Bank that our PPP loan of $140,000 was forgiven in its entirety
and automatically cancelled by the U.S. Small Business Administration.
Based on our operating plans, we do not expect that our current cash and cash
equivalents as of November 14, 2022, will be sufficient to fund our operating,
investing and financing cash flow needs for at least the next twelve months,
assuming our programs advance as currently contemplated. Based upon this review
and the Company's current financial condition, the Company has concluded that
substantial doubt exists as to the Company's ability to continue as a going
concern. We believe we will be able to raise additional capital through debt
financing, private or public equity financings, license agreements,
collaborative agreements or other arrangements with other companies, or other
sources of financing. There can be no assurance that such financing will be
available or will be at terms acceptable to us. If we are unable to raise
capital when needed or on attractive terms, we would be forced to delay, reduce
or eliminate our clinical trials or other operations. If any of these events
occur, our ability to achieve our operational goals would be adversely affected.
Our future capital requirements and the adequacy of available funds will depend
on many factors, including those described in the section titled "Risk Factors."
Depending on the severity and direct impact of these factors on us, we may be
unable to secure additional financing to meet our operating requirements on
commercially acceptable terms favorable to us, or at all.
The Company has filed an omnibus shelf registration statement on Form S-3 that
provides for the aggregate offerings of up to $50.0 million of the Company's
securities subject to various limitations, including limited sales in any
twelve-month period while the Company is subject to the "baby-shelf" rules. The
Company has also filed a registration statement on Form S-1 to register the cash
exercise of the Company's outstanding IPO, underwriter and private warrants.
Cash exercise of the outstanding warrants is only expected to occur when the
trading price of the Company's common stock is in excess of the $10.80 per share
exercise price of the outstanding warrants.
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Sources of Liquidity
Since our inception, we have not generated any revenue from product sales, and
we have incurred significant operating losses and negative cash flows from our
operations. We do not have any products that have achieved regulatory marketing
approval and we do not expect to generate revenue from sales of any product
candidates for several years, if ever.
We have financed our operations primarily through the issuance and sale of
convertible preferred stock and convertible debt. Through the date of this
report, we have raised an aggregate of $35.0 million of gross proceeds from
private placements of our equity and convertible debt securities, the issuance
of securities in our IPO and the exercise of warrants and common stock options.
This amount also includes a loan under the PPP, which was forgiven in February
2021.
Cash Flows
Our primary uses of cash are to fund our operations including research and
development and general and administrative expenses. We will continue to incur
operating losses in the future and expect that our research and development and
general and administrative expenses will continue to increase as we continue our
research and development efforts with respect to clinical development of our
product candidates, further develop our therapy platform and ensure that we are
complying with the requirements of being a public company. The cash used to fund
operating expenses is impacted by the timing of when we pay expenses, as
reflected in the change in our outstanding accounts payable and accrued
expenses.
The following table summarizes our cash flows for the period indicated (in
thousands):
Nine Months Ended
September 30,
2022 2021
Net cash provided by (used in):
Operating activities $ (7,130 ) $ (3,358 )
Investing activities (5,008 ) (15 )
Financing activities 39 19,303
Decrease in cash and cash equivalents $ (12,099 ) $ (15,930 )
Net Cash Used in Operating Activities
Cash used in operating activities for the nine months ended September 30, 2022
reflected a net loss of $7.7 million and a net change in our operating assets
and liabilities of $0.1 million, offset by non-cash charges of $0.5 million,
consisting primarily of stock-based compensation expense. Cash used in operating
activities for the nine months ended September 30, 2021 reflected a net loss of
$4.0 million and a net change in our operating assets and liabilities of $0.1
million, offset by non-cash charges of $0.5 million consisting primarily of
amortization of a debt discount and gain/loss on loan/convertible debt
extinguishments.
Cash Used in Investing Activities
Cash used in investing activities for the nine months ended September 30, 2022
consisted of purchases U.S. Treasury bills, which are classified as
available-for-sale securities. Cash used in investing activities for the nine
months ended September 30, 2021 consisted of capital expenditures made for
leasehold improvements to our office space.
Cash Provided by Financing Activities
Net cash provided by financing activities for the nine months ended September
30, 2022 consisted of proceeds from the exercise of stock options. Net cash
provided by financing activities for the nine months ended September 30, 2021
was $19.3 million, consisting of net proceeds of $14.6 million from the issuance
of common stock in our IPO, $2.0 million from the issuance of convertible notes
and $2.8 million from exercise of warrants and stock options.
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Contractual Obligations and Other Commitments
As of the date of this report, we have a contractual obligation with a secondary
manufacturer to produce our RenovoCath drug medical device.
Critical Accounting Policies and Significant Judgments and Estimates
The accompanying Management's Discussion and Analysis of Financial Condition and
Results of Operations section is based upon our unaudited condensed interim
financial statements and the related disclosures, which have been prepared in
accordance with accounting principles generally accepted in the United States or
GAAP. The preparation of these unaudited condensed interim financial statements
requires us to make estimates, assumptions and judgments that affect the
reported amounts in our unaudited condensed interim financial statements and
accompanying notes. We base our estimates on historical experience and on
various other assumptions that we believe 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 these estimates under different
assumptions or conditions. To the extent that there are material differences
between these estimates and actual results, our future financial statement
presentation, financial condition, results of operations and cash flows will be
affected. Our critical accounting policies and estimates are detailed in our
Annual Report on Form 10-K for the year ended December 31, 2021.
There have been no significant changes to our critical accounting policies or
significant judgments and estimates for the three and nine months ended
September 30, 2022, from those previously disclosed in our Annual Report.
During the three months ended September 30, 2022, we purchased short-term
marketable securities. The accounting policy for the purchased of these
marketable securities is classified as available-for-sale.
Short-Term Marketable Securities
All marketable securities and short-term investments are classified as
available-for-sale and consist of U.S. Treasury bills. Short-term investments
consist of securities with contractual maturities of greater than 90 days from
the original date of purchase. Securities with contractual maturities greater
than one year are classified as short-term investments on the condensed balance
sheets, as we have the ability, if necessary, to liquidate these securities to
meet its liquidity needs in the next 12 months. These securities are carried at
estimated fair value, which is based on quoted market prices or observable
market inputs of almost identical assets, with unrealized gains and losses
included in accumulated other comprehensive income (loss). The amortized cost of
securities is adjusted for amortization of premiums and accretion of discounts
to maturity. Such amortization and accretion are included in interest income or
expense. The cost of securities sold is based on specific identification. Our
investments are subject to a periodic impairment review for other-than-temporary
declines in fair value. The review includes the consideration of the cause of
the impairment including the creditworthiness of the security issuers, the
number of securities in an unrealized loss position, the severity and duration
of the unrealized losses and our intent and ability to hold the investment for a
period of time sufficient to allow for any anticipated recovery in the market
value. When we determine that the decline in fair value of an investment is
below its accounting basis and this decline is other-than-temporary, we reduce
the carrying value of the security and record a loss in the amount of such
decline.
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Emerging Growth Company and Smaller Reporting Company Status
We are an "emerging growth company" as defined in the Jumpstart Our Business
Startups Act ("JOBS Act"). Under the JOBS Act, companies have extended
transition periods available for complying with new or revised accounting
standards. We have elected this exemption to delay adopting new or revised
accounting standards. We will remain an emerging growth company until the
earlier of (1) December 31, 2026, (2) the last day of the fiscal year in which
we have total annual gross revenues of at least $1.07 billion, (3) the date on
which we are deemed to be a "large accelerated filer" as defined in Rule 12b-2
under the Exchange Act, or (4) the date on which we have issued more than $1.0
billion in non-convertible debt securities during the prior three-year period.
An emerging growth company may take advantage of specified reduced reporting
requirements and is relieved of certain other significant requirements that are
otherwise generally applicable to public companies. As an emerging growth
company,
? we may present only two years of audited financial statements, plus unaudited
interim condensed financial statements for any interim period, and related
Management's Discussion and Analysis of Financial Condition and Results of
Operations;
? we may avail ourselves of the exemption from the requirement to obtain an
attestation and report from our auditors on the assessment of our internal
control over financial reporting pursuant to the Sarbanes-Oxley Act;
? we may provide reduced disclosure about our executive compensation
arrangements; and
? we do not require stockholder non-binding advisory votes on executive
compensation or golden parachute arrangements.
We have elected to take advantage of certain reduced disclosure obligations in
this Quarterly Report on Form 10-Q and may elect to take advantage of other
reduced reporting requirements in future filings. As a result, the information
that we provide to you may differ from what other public reporting companies
provide.
We are also a "smaller reporting company," as defined in Rule 12b-2 of the
Exchange Act. We may continue to be a smaller reporting company if, on the last
business day of the second quarter of our calendar year, either (1) the market
value of our stock held by nonaffiliates is less than $250.0 million or (2) our
annual revenue is less than $100.0 million during the most recently completed
fiscal year and the market value of our stock held by non-affiliates is less
than $700.0 million. If we are a smaller reporting company at the time we cease
to be an emerging growth company, we may continue to rely on exemptions from
certain disclosure requirements that are available to smaller reporting
companies. Specifically, as a smaller reporting company we may choose to present
only the two most recent fiscal years of audited financial statements in our
Annual Report on Form 10-K and, like emerging growth companies, smaller
reporting companies have reduced disclosure obligations regarding executive
compensation.
Recently Issued and Adopted Accounting Pronouncements
There were no new accounting pronouncements that were issued or became effective
since the issuance of our 2021 Annual Report on Form 10-K that had, or are
expected to have, a material impact on our unaudited condensed balance sheets,
unaudited condensed statement of operations or unaudited condensed statement of
cash flows.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, nor do we currently have, any
off-balance sheet arrangements, as defined in the rules and regulations of the
SEC.
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